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ATAXIN 50MG

Quick Overview

Veterinary-specific antibiotic with a broad spectrum of activity

Swift and prolonged action with excellent tissue penetration

Low resistance

Superior bactericidal effect

Less side effects

Available as chewable tablets for better palatability

Convenient once-daily dosing for improved compliance

Economical therapy

Product Description

Details

For the use only of a Registered Veterinary Practitioner only, Hospital or Laboratory or a Farm
Enrofloxacin Tablets

ATAXIN

Easy Chews

For Dogs and Cats

COMPOSITION:

ATAXIN 50 ATAXIN 150

Each uncoated tablet contains: Each uncoated tablet contains:

Enrofloxacin EP 50 mg Enrofloxacin EP 150 mg

Approved flavours used Approved flavours used

CATEGORY: Antimicrobial

PHARMACOLOGY

PHARMACODYNAMICS:

Fluoroquinolones elicit their bactericidal properties through interactions with two intercellular enzymes -
DNA gyrase (DNA topoisomerase II) and DNA topoisomerase IV - which are essential for bacterial DNA
transcription, synthesis and replication. It is believed that fluoroquinolones activity bind with DNA:
enzyme complexes and thereby inhibit the essential processes catalyzed by the enzymes (DNA
supercoiling and chromosomal decatenation). The ultimate outcome of fluoroquinolone intervention is
DNA fragmentation and bacterial cell death.

PHARMACOKINETICS:

Approximately 80% of the orally administered dose enters the systemic circulation unchanged. The
eliminating organs, based on the drug’s body clearance time, can readily remove the drug with no
indication that the eliminating mechanisms are saturated. The primary route of excretion is via urine.
The absorption and elimination characteristics beyond this point are unknown.

In cats, no oral absorption information is available at other than 2.5 mg/kg, administered orally as a
single dose. Saturable absorption and/or elimination processes may occur at greater doses.

Following an oral dose in dogs of 2.5 mg/kg (1.13 mg/lb), enrofloxacin reached 50% of its maximum
serum concentration in 15 minutes and peak serum level was reached in one hour. The elimination half-
life in dogs is approximately 21/2 - 3 hours at that dose, while in cats it is greater than 4 hours.

INDICATIONS:

Enrofloxacin tablet is indicated for use in dogs and cats in the treatment of bacterial infections of
alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa.

DOSAGE AND ADMINISTRATION:

Dogs and Cats:

The dose rate of enrofloxacin is 5mg/kg bodyweight.


One 50mg tablet per 10kg

Or one 150mg tablet per 30kg

To be administered once daily or as a divided dose twice daily for 3 to 10 days with or without food.

Dosage = 5 mg/kg BW Daily

Tablets

Ataxin 50 mg

Ataxin 150 mg

Daily

5 Kg

½ Tablet
10 Kg

1Tablet

15 kg

1 ½ Tablets

20 kg

2 Tablets

30 kg

1 Tablet
45 kg

1 ½ Tablets

60 kg

2 Tablets

CONTRAINDICATIONS, WARNINGS ETC:

Enrofloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones.

Do not exceed the recommended dosage. In cat, retinotoxic effects can occur when the recommended
dose is exceeded.

Not for use in dogs less than 1 year of age or in exceptionally large breeds of dogs with a longer growth
period under 18 months of age, an articular cartilage may be affected during the period of rapid growth.

Not recommended for use in cats less than 8 weeks of age.

This product should not be used for prophylaxis.

Wash hands after use.

DRUG INTERACTION: It should not be used in combination with cloramphenicol, macrolides or


tetracyclines. Since floroquinolones may increase the availability of the theophyline, its dose should be
regulated when given with enrofloxacin.
PREGNANCY AND LACTATION:

The safety of enrofloxacin in breeding female cats has not been established. Use only according to the
benefit/risk assessment by the responsible veterinarian.

USE DURING LACTATION:

As enrofloxacin passes into the maternal milk, the use is not recommended during lactation.

ADVERSE DRUG REACTIONS:

In dogs enrofloxacin may affect articular cartilage during the period of rapid growth.

OVERDOSAGE:

In accidental overdose vomiting, diarrhoea and CNS/behavioral changes may occur. There is no antidote
and treatment should be symptomatic.

STORAGE: Store in a cool and dry place.

Keep out of reach of children.

PRESENTATION: Blister of 10 tablets

LAST UPDATE: August 2013.


Veterinary. Not for human use. For animal treatment only.

For the use only of a Registered Veterinary Practitioner only, Hospital or Laboratory or a Farm

Enrofloxacin Tablets

Details

For the use only of a Registered Veterinary Practitioner only, Hospital or Laboratory or a Farm

Enrofloxacin Tablets

ATAXIN

Easy Chews

For Dogs and Cats

COMPOSITION:

ATAXIN 50 ATAXIN 150

Each uncoated tablet contains: Each uncoated tablet contains:


Enrofloxacin EP 50 mg Enrofloxacin EP 150 mg

Approved flavours used Approved flavours used

CATEGORY: Antimicrobial

PHARMACOLOGY

PHARMACODYNAMICS:

Fluoroquinolones elicit their bactericidal properties through interactions with two intercellular enzymes -
DNA gyrase (DNA topoisomerase II) and DNA topoisomerase IV - which are essential for bacterial DNA
transcription, synthesis and replication. It is believed that fluoroquinolones activity bind with DNA:
enzyme complexes and thereby inhibit the essential processes catalyzed by the enzymes (DNA
supercoiling and chromosomal decatenation). The ultimate outcome of fluoroquinolone intervention is
DNA fragmentation and bacterial cell death.

PHARMACOKINETICS:

Approximately 80% of the orally administered dose enters the systemic circulation unchanged. The
eliminating organs, based on the drug’s body clearance time, can readily remove the drug with no
indication that the eliminating mechanisms are saturated. The primary route of excretion is via urine.
The absorption and elimination characteristics beyond this point are unknown.

In cats, no oral absorption information is available at other than 2.5 mg/kg, administered orally as a
single dose. Saturable absorption and/or elimination processes may occur at greater doses.

Following an oral dose in dogs of 2.5 mg/kg (1.13 mg/lb), enrofloxacin reached 50% of its maximum
serum concentration in 15 minutes and peak serum level was reached in one hour. The elimination half-
life in dogs is approximately 21/2 - 3 hours at that dose, while in cats it is greater than 4 hours.
INDICATIONS:

Enrofloxacin tablet is indicated for use in dogs and cats in the treatment of bacterial infections of
alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa.

DOSAGE AND ADMINISTRATION:

Dogs and Cats:

The dose rate of enrofloxacin is 5mg/kg bodyweight.

One 50mg tablet per 10kg

Or one 150mg tablet per 30kg

To be administered once daily or as a divided dose twice daily for 3 to 10 days with or without food.

Dosage = 5 mg/kg BW Daily

Tablets

Ataxin 50 mg

Ataxin 150 mg
Daily

5 Kg

½ Tablet

10 Kg

1Tablet

15 kg

1 ½ Tablets

20 kg
2 Tablets

30 kg

1 Tablet

45 kg

1 ½ Tablets

60 kg

2 Tablets

CONTRAINDICATIONS, WARNINGS ETC:


Enrofloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones.

Do not exceed the recommended dosage. In cat, retinotoxic effects can occur when the recommended
dose is exceeded.

Not for use in dogs less than 1 year of age or in exceptionally large breeds of dogs with a longer growth
period under 18 months of age, an articular cartilage may be affected during the period of rapid growth.

Not recommended for use in cats less than 8 weeks of age.

This product should not be used for prophylaxis.

Wash hands after use.

DRUG INTERACTION: It should not be used in combination with cloramphenicol, macrolides or


tetracyclines. Since floroquinolones may increase the availability of the theophyline, its dose should be
regulated when given with enrofloxacin.

PREGNANCY AND LACTATION:

The safety of enrofloxacin in breeding female cats has not been established. Use only according to the
benefit/risk assessment by the responsible veterinarian.

USE DURING LACTATION:

As enrofloxacin passes into the maternal milk, the use is not recommended during lactation.

ADVERSE DRUG REACTIONS:

In dogs enrofloxacin may affect articular cartilage during the period of rapid growth.

OVERDOSAGE:
In accidental overdose vomiting, diarrhoea and CNS/behavioral changes may occur. There is no antidote
and treatment should be symptomatic.

STORAGE: Store in a cool and dry place.

Keep out of reach of children.

PRESENTATION: Blister of 10 tablets

LAST UPDATE: August 2013.

Veterinary. Not for human use. For animal treatment only.

For the use only of a Registered Veterinary Practitioner only, Hospital or Laboratory or a Farm

Enrofloxacin Tablets

COMPOSITION:

Each uncoated tablet contains:

Clindamycin Hydrochloride USP 25 mg

Colours: Iron Oxide Red NF

Each uncoated tablet contains:


Clindamycin Hydrochloride USP 150 mg

Colours: Iron Oxide Red NF

Each uncoated tablet contains:

Clindamycin Hydrochloride USP 300 mg

Colours: Iron Oxide Red NF

CATEGORY: Anti-bacterial

PHARMACOLOGY

PHARMACODYNAMICS:

Clindamycin inhibits bacterial protein synthesis at the ribosomal (50s sub-unit) level.

PHARMACOKINETICS:

Absorption:

Clindamycin hydrochloride is rapidly absorbed from the canine gastrointestinal tract following oral
administration. Effective clindamycin antibacterial serum levels are reached within 30 minutes following
administration of the therapeutic dose.
Serum values:

Therapeutic serum levels of clindamycin can be maintained by oral administration of 5.5 mg/kg
bodyweight every 12 hours or 11 mg/kg bodyweight every 24 hours; peak serum concentrations are on
average reached 75 minutes after oral administration. The biological plasma half-life of clindamycin in
the dog is approximately 5 hours. No accumulation of bioactivity has been observed in dogs after
several oral administrations.

Metabolism and Excretion:

Extensive research of the metabolism and excretion pattern of clindamycin shows that the parent
molecule as well as bioactive and bio-inactive metabolites is excreted via the urine and faeces. Nearly all
bioactivity in the serum following oral administration is due to the parent molecule (clindamycin).

INDICATIONS:

Clindamycin uncoated tablet are indicated for use in dogs as follows:

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections,
caused by or associated with Staphylococcus spp, Streptococcus spp (except Streptococcus faecalis),
Bacteroides spp, Fusobacterium necrophorum, and Clostridium perfringens. To help provide
antimicrobial cover during dental procedures.

For the treatment of superficial pyoderma associated with Staphylococcus intermedius.


For the treatment of osteomyelitis, caused by Staphylococcus aureus.

Before Clindamycin therapy is initiated, the involved pathogens should be identified and sensitivity to
clindamycin established.

DOSAGE AND ADMINISTRATION:

For oral administration only.

1. For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections
in dogs, administer either:

•5.5 mg/kg of bodyweight every 12 hours for 7-10 days, or

•11 mg/kg of bodyweight every 24 hours for 7-10 days

If no clinical response is seen within 4 days, redetermine the diagnosis. To help provide antimicrobial
cover during dental procedures, a 10 day course is recommended. This should be initiated five days
before dental therapy and continued for five days thereafter. In dogs, treatment may be extended to a
maximum of 28 days based on clinical judgment.

2. For the treatment of superficial pyoderma in dogs, administer either:

•5.5 mg/kg of bodyweight every 12 hours, or


•11 mg/kg of bodyweight every 24 hours

Therapy of canine superficial pyoderma is usually recommended for 21 days, with extension of therapy
based on clinical judgment.

3. For the treatment of osteomyelitis in dogs, administer:

•11 mg/kg of bodyweight every 12 hours for a minimum of 28 days

If no clinical response is seen within 14 days, the treatment should be stopped and the diagnosis
redetermined.

Dosage table:

Bodyweight

Superficial pyoderma

Dental infections, wounds and abscesses

Osteomyelitis
5.5 mg/kg/12 h - 21 days

11 mg/kg/24 h - 7-10 days

11 mg/kg/12 h - 28 days

4.5 kg

1 x 25 mg bid

2 x 25 mg od

2 x 25 mg bid

13.5 kg

1 x 150 mg od

1 x 150 mg od

1 x 150 mg bid

27.0 kg
1 x 300 mg od

1 x 300 mg od

1 x 300 mg bid

CONTRAINDICATIONS, WARNINIGS ETC:

Do not use in animals that are hypersensitive to preparations containing clindamycin or lincomycin.

Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of
clindamycin by these species may result in severe gastrointestinal disturbance.

Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated
between clindamycin, erythromycin and other macrolides antibiotics.

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood
counts should be performed.
Animals with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic
aberrations should be dosed with caution and should be monitored by serum examination during high-
dose clindamycin therapy.

Vomiting and diarrhoea have occasionally been observed.

Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia
and yeasts. In cases of superinfection, appropriate measures must be taken according to the clinical
situation.

While high dose studies in rats suggest that clindamycin is not a teratogen and does not significantly
affect the breeding performance of males and females, safety in gestating bitches or breeding male dogs
has not been established.

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may
enhance the action of other neuromuscular blocking agents. Clindamycin uncoated tablets should be
used with caution in animals receiving such agents.
Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they antagonize
each other at their site of action at the 50S ribosomal sub-unit.

PREGNANCY AND LACTATION:

Safety in gestating bitches or breeding male dogs has not been established.

INTERACTIONS

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may
enhance the action of other neuromuscular blocking agents. Clindamycin uncoated tablets should be
used with caution in animals receiving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they antagonize
each other at their site of action at the 50S ribosomal sub-unit.

ADVERSE DRUG REACTIONS:

Vomiting and diarrhoea have occasionally been observed.


Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia
and yeasts. In cases of superinfection, appropriate measures must be taken according to the clinical
situation.

OVERDOSAGE:

None known

PRESENTATION: Blister of ten tablets

STORAGE: Store in a cool and dry place.

Keep out of reach of children.

Manufactured by: Sava HealthCare Limited

Details

COMPOSITION:

Each uncoated tablet contains:


Clindamycin Hydrochloride USP 25 mg

Colours: Iron Oxide Red NF

Each uncoated tablet contains:

Clindamycin Hydrochloride USP 150 mg

Colours: Iron Oxide Red NF

Each uncoated tablet contains:

Clindamycin Hydrochloride USP 300 mg

Colours: Iron Oxide Red NF

CATEGORY: Anti-bacterial

PHARMACOLOGY

PHARMACODYNAMICS:

Clindamycin inhibits bacterial protein synthesis at the ribosomal (50s sub-unit) level.

PHARMACOKINETICS:
Absorption:

Clindamycin hydrochloride is rapidly absorbed from the canine gastrointestinal tract following oral
administration. Effective clindamycin antibacterial serum levels are reached within 30 minutes following
administration of the therapeutic dose.

Serum values:

Therapeutic serum levels of clindamycin can be maintained by oral administration of 5.5 mg/kg
bodyweight every 12 hours or 11 mg/kg bodyweight every 24 hours; peak serum concentrations are on
average reached 75 minutes after oral administration. The biological plasma half-life of clindamycin in
the dog is approximately 5 hours. No accumulation of bioactivity has been observed in dogs after
several oral administrations.

Metabolism and Excretion:

Extensive research of the metabolism and excretion pattern of clindamycin shows that the parent
molecule as well as bioactive and bio-inactive metabolites is excreted via the urine and faeces. Nearly all
bioactivity in the serum following oral administration is due to the parent molecule (clindamycin).

INDICATIONS:

Clindamycin uncoated tablet are indicated for use in dogs as follows:


For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections,
caused by or associated with Staphylococcus spp, Streptococcus spp (except Streptococcus faecalis),
Bacteroides spp, Fusobacterium necrophorum, and Clostridium perfringens. To help provide
antimicrobial cover during dental procedures.

For the treatment of superficial pyoderma associated with Staphylococcus intermedius.

For the treatment of osteomyelitis, caused by Staphylococcus aureus.

Before Clindamycin therapy is initiated, the involved pathogens should be identified and sensitivity to
clindamycin established.

DOSAGE AND ADMINISTRATION:

For oral administration only.

1. For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections
in dogs, administer either:

•5.5 mg/kg of bodyweight every 12 hours for 7-10 days, or

•11 mg/kg of bodyweight every 24 hours for 7-10 days

If no clinical response is seen within 4 days, redetermine the diagnosis. To help provide antimicrobial
cover during dental procedures, a 10 day course is recommended. This should be initiated five days
before dental therapy and continued for five days thereafter. In dogs, treatment may be extended to a
maximum of 28 days based on clinical judgment.
2. For the treatment of superficial pyoderma in dogs, administer either:

•5.5 mg/kg of bodyweight every 12 hours, or

•11 mg/kg of bodyweight every 24 hours

Therapy of canine superficial pyoderma is usually recommended for 21 days, with extension of therapy
based on clinical judgment.

3. For the treatment of osteomyelitis in dogs, administer:

•11 mg/kg of bodyweight every 12 hours for a minimum of 28 days

If no clinical response is seen within 14 days, the treatment should be stopped and the diagnosis
redetermined.

Dosage table:

Bodyweight

Superficial pyoderma
Dental infections, wounds and abscesses

Osteomyelitis

5.5 mg/kg/12 h - 21 days

11 mg/kg/24 h - 7-10 days

11 mg/kg/12 h - 28 days

4.5 kg

1 x 25 mg bid

2 x 25 mg od

2 x 25 mg bid

13.5 kg

1 x 150 mg od

1 x 150 mg od
1 x 150 mg bid

27.0 kg

1 x 300 mg od

1 x 300 mg od

1 x 300 mg bid

CONTRAINDICATIONS, WARNINIGS ETC:

Do not use in animals that are hypersensitive to preparations containing clindamycin or lincomycin.

Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of
clindamycin by these species may result in severe gastrointestinal disturbance.

Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated
between clindamycin, erythromycin and other macrolides antibiotics.
During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood
counts should be performed.

Animals with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic
aberrations should be dosed with caution and should be monitored by serum examination during high-
dose clindamycin therapy.

Vomiting and diarrhoea have occasionally been observed.

Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia
and yeasts. In cases of superinfection, appropriate measures must be taken according to the clinical
situation.

While high dose studies in rats suggest that clindamycin is not a teratogen and does not significantly
affect the breeding performance of males and females, safety in gestating bitches or breeding male dogs
has not been established.
Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may
enhance the action of other neuromuscular blocking agents. Clindamycin uncoated tablets should be
used with caution in animals receiving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they antagonize
each other at their site of action at the 50S ribosomal sub-unit.

PREGNANCY AND LACTATION:

Safety in gestating bitches or breeding male dogs has not been established.

INTERACTIONS

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may
enhance the action of other neuromuscular blocking agents. Clindamycin uncoated tablets should be
used with caution in animals receiving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they antagonize
each other at their site of action at the 50S ribosomal sub-unit.
ADVERSE DRUG REACTIONS:

Vomiting and diarrhoea have occasionally been observed.

Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia
and yeasts. In cases of superinfection, appropriate measures must be taken according to the clinical
situation.

OVERDOSAGE:

None known

PRESENTATION: Blister of ten tablets

STORAGE: Store in a cool and dry place.

Keep out of reach of children.

Manufactured by: Sava HealthCare Limited


Details

COMPOSITION:

Each uncoated tablet contains:

Clindamycin Hydrochloride USP 25 mg

Colours: Iron Oxide Red NF

Each uncoated tablet contains:

Clindamycin Hydrochloride USP 150 mg

Colours: Iron Oxide Red NF

Each uncoated tablet contains:

Clindamycin Hydrochloride USP 300 mg

Colours: Iron Oxide Red NF

CATEGORY: Anti-bacterial

PHARMACOLOGY
PHARMACODYNAMICS:

Clindamycin inhibits bacterial protein synthesis at the ribosomal (50s sub-unit) level.

PHARMACOKINETICS:

Absorption:

Clindamycin hydrochloride is rapidly absorbed from the canine gastrointestinal tract following oral
administration. Effective clindamycin antibacterial serum levels are reached within 30 minutes following
administration of the therapeutic dose.

Serum values:

Therapeutic serum levels of clindamycin can be maintained by oral administration of 5.5 mg/kg
bodyweight every 12 hours or 11 mg/kg bodyweight every 24 hours; peak serum concentrations are on
average reached 75 minutes after oral administration. The biological plasma half-life of clindamycin in
the dog is approximately 5 hours. No accumulation of bioactivity has been observed in dogs after
several oral administrations.

Metabolism and Excretion:

Extensive research of the metabolism and excretion pattern of clindamycin shows that the parent
molecule as well as bioactive and bio-inactive metabolites is excreted via the urine and faeces. Nearly all
bioactivity in the serum following oral administration is due to the parent molecule (clindamycin).
INDICATIONS:

Clindamycin uncoated tablet are indicated for use in dogs as follows:

For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections,
caused by or associated with Staphylococcus spp, Streptococcus spp (except Streptococcus faecalis),
Bacteroides spp, Fusobacterium necrophorum, and Clostridium perfringens. To help provide
antimicrobial cover during dental procedures.

For the treatment of superficial pyoderma associated with Staphylococcus intermedius.

For the treatment of osteomyelitis, caused by Staphylococcus aureus.

Before Clindamycin therapy is initiated, the involved pathogens should be identified and sensitivity to
clindamycin established.

DOSAGE AND ADMINISTRATION:

For oral administration only.

1. For the treatment of infected wounds and abscesses, and infected mouth cavity and dental infections
in dogs, administer either:

•5.5 mg/kg of bodyweight every 12 hours for 7-10 days, or

•11 mg/kg of bodyweight every 24 hours for 7-10 days


If no clinical response is seen within 4 days, redetermine the diagnosis. To help provide antimicrobial
cover during dental procedures, a 10 day course is recommended. This should be initiated five days
before dental therapy and continued for five days thereafter. In dogs, treatment may be extended to a
maximum of 28 days based on clinical judgment.

2. For the treatment of superficial pyoderma in dogs, administer either:

•5.5 mg/kg of bodyweight every 12 hours, or

•11 mg/kg of bodyweight every 24 hours

Therapy of canine superficial pyoderma is usually recommended for 21 days, with extension of therapy
based on clinical judgment.

3. For the treatment of osteomyelitis in dogs, administer:

•11 mg/kg of bodyweight every 12 hours for a minimum of 28 days

If no clinical response is seen within 14 days, the treatment should be stopped and the diagnosis
redetermined.
Dosage table:

Bodyweight

Superficial pyoderma

Dental infections, wounds and abscesses

Osteomyelitis

5.5 mg/kg/12 h - 21 days

11 mg/kg/24 h - 7-10 days

11 mg/kg/12 h - 28 days

4.5 kg

1 x 25 mg bid

2 x 25 mg od
2 x 25 mg bid

13.5 kg

1 x 150 mg od

1 x 150 mg od

1 x 150 mg bid

27.0 kg

1 x 300 mg od

1 x 300 mg od

1 x 300 mg bid

CONTRAINDICATIONS, WARNINIGS ETC:

Do not use in animals that are hypersensitive to preparations containing clindamycin or lincomycin.
Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of
clindamycin by these species may result in severe gastrointestinal disturbance.

Clindamycin and erythromycin show parallel resistance. Partial cross-resistance has been demonstrated
between clindamycin, erythromycin and other macrolides antibiotics.

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood
counts should be performed.

Animals with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic
aberrations should be dosed with caution and should be monitored by serum examination during high-
dose clindamycin therapy.

Vomiting and diarrhoea have occasionally been observed.

Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia
and yeasts. In cases of superinfection, appropriate measures must be taken according to the clinical
situation.
While high dose studies in rats suggest that clindamycin is not a teratogen and does not significantly
affect the breeding performance of males and females, safety in gestating bitches or breeding male dogs
has not been established.

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may
enhance the action of other neuromuscular blocking agents. Clindamycin uncoated tablets should be
used with caution in animals receiving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they antagonize
each other at their site of action at the 50S ribosomal sub-unit.

PREGNANCY AND LACTATION:

Safety in gestating bitches or breeding male dogs has not been established.

INTERACTIONS
Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may
enhance the action of other neuromuscular blocking agents. Clindamycin uncoated tablets should be
used with caution in animals receiving such agents.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides as they antagonize
each other at their site of action at the 50S ribosomal sub-unit.

ADVERSE DRUG REACTIONS:

Vomiting and diarrhoea have occasionally been observed.

Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as resistant clostridia
and yeasts. In cases of superinfection, appropriate measures must be taken according to the clinical
situation.

OVERDOSAGE:

None known

PRESENTATION: Blister of ten tablets


STORAGE: Store in a cool and dry place.

Keep out of reach of children.

Manufactured by: Sava HealthCare Limited

Details

METAFLAM CHEWABLE TABLET

MELOXICAM 2.5 MG TABLET

COMPOSITION:

CATEGORY: Non-steroidal antiinflammatory drug

PHARMACOLOGY

Meloxicam is a non-steroidal antiinflammatory compound of the oxicam group which acts by inhibition
of prostaglandin synthesis.

Meloxicam exerts anti-inflammatory, anti-exudative, analgesic and antipyretic effects. It inhibits


leukocyte infiltration into the inflamed tissue and prevents bone and cartilage destruction. To a minor
extent it also inhibits collagen-induced thrombocyte aggregation.
INDICATIONS:

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

DOSAGE AND ADMINISTRATION:

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam body weight. Each chewable contains 2.5 mg meloxicam, which corresponds to the daily
maintenance dose for a 25 kg body weight dog respectively. Each chewable tablet can be halved for
accurate dosing according to the individual body weight of the animal. Meloxicam chewable tablets can
be administered with or without food.

Dose scheme for the maintenance dose:

Body weight

Number of Chewable Tablets

20.1 - 25.0

25.1 - 35.0

35.1 - 50.0

The use of meloxicam oral suspension for dogs may be considered for an even more precise dosing. For
dogs weighing less than 20 kg the use of Metaflam Oral Suspension is recommended.

A clinical response is usually seen within 3-4 days. Treatment should be discontinued after 10 days at the
latest if no clinical improvement is apparent.

CONTRAINDICATIONS, WARNINIGS ETC:

Do not use in pregnant or lactating animals.

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
PRECAUTIONS

Meloxicam should not be administered concurrently with steroidal or other non-steroidal anti-
inflammatory drugs, aminoglycoside antibiotics or anti-coagulant agents.

Pre-treatment with anti-inflammatory drugs may result in additional or increased adverse effects and
accordingly a treatment free period with such drugs should be observed for at least 24 hours before
commencement with meloxicam. The treatment free period, however, should take into account the
pharmacokinetic properties of the drugs used previously.

Avoid use in dehydrated, hypovolaemic or hypotensive animals as there is potential risk of increased
renal toxicity.

PREGNANCY AND LACTATION:

The safety of the veterinary medicinal product has not been established during pregnancy or lactation.

ADVERSE DRUG REACTIONS:

Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult
blood, letharthy and renal failure have occasionally been reported. In very rare cases haemorrhagic
diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.
These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

OVERDOSAGE:

In case of overdose, symptomatic treatment should be initiated.

Details

METAFLAM CHEWABLE TABLET

MELOXICAM 1MG AND 2.5 MG TABLET

CATEGORY: Non-steroidal antiinflammatory drug

PHARMACOLOGY

Meloxicam is a non-steroidal antiinflammatory compound of the oxicam group which acts by inhibition
of prostaglandin synthesis.

Meloxicam exerts anti-inflammatory, anti-exudative, analgesic and antipyretic effects. It inhibits


leukocyte infiltration into the inflamed tissue and prevents bone and cartilage destruction. To a minor
extent it also inhibits collagen-induced thrombocyte aggregation.

INDICATIONS:

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
DOSAGE AND ADMINISTRATION:

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam body weight. Each chewable contains either 1 mg or 2.5 mg meloxicam, which corresponds to
the daily maintenance dose for a 10 kg or a 25 kg body weight dog respectively. Each chewable tablet
can be halved for accurate dosing according to the individual body weight of the animal. Meloxicam
chewable tablets can be administered with or without food.

Dose scheme for the maintenance dose:

Body weight (Kg)

Number of Chewable Tablets

1 mg

2.5 mg

4.0 - 7.0

-
7.1 - 10.0

10.1 - 15.0

15.1 - 20.0

20.1 - 25.0

25.1 - 35.0

35.1 - 50.0

A clinical response is usually seen within 3-4 days. Treatment should be discontinued after 10 days at the
latest if no clinical improvement is apparent.

CONTRAINDICATIONS, WARNINIGS ETC:

Do not use in pregnant or lactating animals.

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
PRECAUTIONS

Meloxicam should not be administered concurrently with steroidal or other non-steroidal anti-
inflammatory drugs, aminoglycoside antibiotics or anti-coagulant agents.

Pre-treatment with anti-inflammatory drugs may result in additional or increased adverse effects and
accordingly a treatment free period with such drugs should be observed for at least 24 hours before
commencement with meloxicam. The treatment free period, however, should take into account the
pharmacokinetic properties of the drugs used previously.

Avoid use in dehydrated, hypovolaemic or hypotensive animals as there is potential risk of increased
renal toxicity.

PREGNANCY AND LACTATION:

The safety of the veterinary medicinal product has not been established during pregnancy or lactation.

ADVERSE DRUG REACTIONS:

Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult
blood, letharthy and renal failure have occasionally been reported. In very rare cases haemorrhagic
diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.
These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

OVERDOSAGE:

In case of overdose, symptomatic treatment should be initiated.

METAFLAM

Meloxicam Oral Suspension BP (Vet)

COMPOSITION:

Each ml contains:

Meloxicam BP 1.5 mg

Aqueous base q.s.

CHEMISTRY: 4-hydroxy-2-methyl-N-(5-methyl-1,3-thiazol-2-yl)-2 H-1,2-benzothiazine-3-

carboxamide 1,1-dioxide
CATEGORY: Analgesic, Anti-inflammatory & Antipyratic

PHARMACOLOGY

PHARMACODYNAMICS:

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition
of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic
effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits
collagen-induced thrombocyte aggregation. In vitro and in vivo studies have reported that meloxicam
inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

PHARMACOKINETICS:

Meloxicam has nearly 100% bioavailability when administered orally with food. The terminal elimination
half-life after a single dose is estimated to be approximately 24 hrs (+/-30%) regardless of route of
administration. There is no evidence of statistically significant gender differences in drug
pharmacokinetics. Drug bioavailability, volume of distribution and total systemic clearance remain
constant up to 5 times the recommended dose for use in dogs. However, there is some evidence of
enhanced drug accumulation and terminal elimination half-life prolongation when dogs are dosed for 45
days or longer. Peak drug concentrations can be expected to occur within about 7.5 hrs after oral
administration. Corresponding peak concentration is approximately 0.464 mcg/mL following a 0.09
mg/lb (0.2 mg/kg) oral dose. The drug is 97% bound to canine plasma proteins.

INDICATIONS:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

DOSAGE AND ADMINISTRATION:

Metaflam oral suspension can be given using dropper bottle: Four drops for each kilogram of bodyweight
on the first day and two drops for each kilogram of bodyweight daily as maintenance dose.

Dose regimen:

Day 0

(0.2 mg meloxicam/kg bodyweight on the first day).

Maintenance Dose

(0.1 mg meloxicam/kg bodyweight).

0.25 ml – 1.9 kg

0.25 ml – 3.75 kg

0.3 ml– 2.25 kg

0.3 ml– 4.5 kg


0.5 ml – 3.75 kg

0.5 ml – 7.5 kg

0.6 ml – 4.5 kg

0.6 ml – 9.0 kg

1 ml – 7.5 kg

1 ml – 15 kg

1.5 ml – 11.25 kg

1.5 ml – 22.5 kg

2 ml – 15 kg

2 ml – 30 kg

2.5 ml – 18.75 kg

2.5 ml – 37.5 kg

3 ml – 22.5 kg
3 ml – 45 kg

3.5 ml – 26.25 kg

3.5 ml – 52.5 kg

4 ml – 30 kg

4 ml – 60 kg

4.5 ml – 33.75 kg

4.5 ml – 67.5 kg

5 ml - 37.5 kg

5 ml – 75 kg

WARNINGS AND PRECAUTIONS:


Warning: Repeated use of meloxicam in cats has been associated with acute renal failure and death. Do
not administer additional injectable or oral meloxicam to cats.

Not for use in humans. Keep out of reach of children. Consult a physician in case of accidental ingestion
by humans. For oral use in dogs only. As with any NSAID all dogs should undergo a thorough history and
physical examination before the initiation of NSAID therapy.

Dogs with known hypersensitivity to meloxicam should not receive meloxicam oral suspension. Do not
use in cats. Appropriate laboratory testing to establish hematological and serum biochemical baseline
data is recommended prior to and periodically during administration. Owner should be advised to
observe their dog for signs of potential drug toxicity and be given client information sheet about
meloxicam.

Precautions:
The safe use of meloxicam oral suspension in dogs younger than 6 months of age, dogs used for
breeding, or in pregnant or lactating bitches has not been evaluated. Meloxicam is not recommended for
use in dogs with bleeding disorders, as safety has not been established in dogs with these disorders. As a
class, cyclooxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic
toxicity. Sensitivity to drug associated adverse events varies with the individual patient. Patients at
greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or those
with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially
nephrotoxic drugs should be carefully approached. Since many NSAIDs possess the potential to produce
gastrointestinal ulceration, concomitant use of meloxicam oral suspension with other anti-inflammatory
drugs, such as NSAIDs or corticosteroids, should be avoided or closely monitored. Consider appropriate
washout times when switching from corticosteroid use or from one NSAID to another in dogs. The use of
concomitantly protein-bound drugs with meloxicam oral suspension has not been studied in dogs.
Commonly used protein-bound drugs include cardiac, anticonvulsant and behavioral medications. The
influence of concomitant drugs that may inhibit metabolism of meloxicam oral suspension has not been
evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.

INTERACTIONS:

Combinations containing any of the following medications, depending on the amount present, may also
interact with this medication.

Anticoagulants : Because nonsteroidal anti-inflammatory drugs [NSAIDs] have been associated with
inhibition of platelet aggregation and with the potential for gastrointestinal ulceration or bleeding,
concurrent administration with an anticoagulant could increase the risk of adverse effects; however,
studies in dogs have indicated that effects on thromboxane A2 [as measured by thromboxane B2] are
minimal, making antiplatelet effects unlikely when administered at recommended dosages; also, it has
been reported that no change in buccal mucosal bleeding time occurs in healthy dogs with a single 0.2
mg/kg dose.
Anti-inflammatory drugs, nonsteroidal (NSAID) or Corticosteroids: Concurrent administration of more
than one NSAID or of corticosteroids with a NSAID may greatly increase the risk of adverse effects.

Diuretics: Animals on diuretic therapy could have an increased risk of renal toxicity with NSAID
administration.

Nephrotoxic medications: NSAIDs have been associated with renal toxicity; therefore, administration
with other nephrotoxic medications should be viewed with caution.

PREGNANCY AND LACTATION:

Pregnancy/Lactation

Dogs: The safety of administering meloxicam to dogs during breeding, pregnancy or lactation has not
been studied.

ADVERSE DRUG REACTIONS:

In most cases, adverse effects were transient and disappeared after termination of treatment. In rare
cases however, death has been associated with some of these adverse reactions. The following
suspected adverse effects have been reported:

Gastrointestinal: Vomiting, diarrhea, inappetence, melena, hematemesis, ulceration.

Central Nervous System/Behavioral: Ataxia, seizures, sleepiness, hyperactivity, depression, trembling.


Renal: Elevated creatinine and BUN, acute renal failure.

Dermatologic: Pruritus, eczema, focal alopecia, moist dermatitis (hot spots).

Hypersensitivity: Urticaria, allergic dermatitis.

Hematologic: Immune mediated hemolytic anemia, immune mediated thrombocytopenia.

Hepatic: Elevated liver enzymes, jaundice.

Information for Dog Owners: Meloxicam, like other drugs of its class, is not free from adverse reactions.
Owners should be advised of the potential for adverse reactions and be informed of the clinical signs
associated with drug intolerance. Adverse reactions may include vomiting, diarrhea, decreased appetite,
dark or tarry stools, increased water consumption, increased urination, pale gums due to anemia,
yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or
behavioral changes. Serious adverse reactions associated with this drug class can occur without warning
and in rare situations result in death (see Adverse Reactions). Owners should be advised to discontinue
meloxicam and contact their veterinarian immediately if signs of intolerance are observed. The vast
majority of patients with drug related adverse reactions have recovered when the signs are recognized;
the drug is withdrawn and veterinary care if appropriate is initiated. Owners should be advised of the
importance of periodic follow up for all dogs during administration of any NSAID.

OVERDOSAGE:

In case of overdosing, symptomatic treatment should be initiated.


PRESENTATION: 32ml and 100ml HDPE bottle with measuring syringe.

STORAGE: Store below 300C. Protect from light.

For oral use in dogs only.

Keep out of reach of children

CARODYL

Carprofen Chewable Tablets

COMPOSITION:

Each chewable tablet contains:

Carprofen 25 mg

Excipients q.s.

Each chewable tablet contains:

Carprofen 75 mg
Excipients q.s.

Each chewable tablet contains:

Carprofen 100 mg

Excipients q.s.

CHEMISTRY: 6-chloro-α-methyl-9H-carbazole-2-acetic acid.

CATEGORY: Non - steroidal anti-inflammatory drug

DESCRIPTION: Carodyl® (Carprofen) is a non-steroidal anti-inflammatory drug (NSAIDs) of the propionic


acid class that includes ibuprofen, naproxen and ketoprofen. Carprofen is the nonproprietary designation
for a substituted carbazole.

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

Carprofen is a member of the 2-arylpropionic acid group of non-steroidal anti-inflammatory drugs


(NSAIDs), and possesses anti-inflammatory, analgesic and antipyretic activity. Carprofen is a chiral drug.
Carprofen, like most other NSAIDs is an inhibitor of the enzyme cyclooxygenase of the arachidonic acid
cascade. However, the inhibition of prostaglandin synthesis by carprofen is slight in relation to its anti-
inflammatory and analgesic potency. The precise mode of action of carprofen is not clear.

CARODYL
Carprofen Chewable Tablets

COMPOSITION:

Each chewable tablet contains:

Carprofen 25 mg

Excipients q.s.

Each chewable tablet contains:

Carprofen 75 mg

Excipients q.s.

Each chewable tablet contains:

Carprofen 100 mg

Excipients q.s.

CHEMISTRY: 6-chloro-α-methyl-9H-carbazole-2-acetic acid.

CATEGORY: Non - steroidal anti-inflammatory drug


DESCRIPTION: Carodyl® (Carprofen) is a non-steroidal anti-inflammatory drug (NSAIDs) of the propionic
acid class that includes ibuprofen, naproxen and ketoprofen. Carprofen is the nonproprietary designation
for a substituted carbazole.

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

Carprofen is a member of the 2-arylpropionic acid group of non-steroidal anti-inflammatory drugs


(NSAIDs), and possesses anti-inflammatory, analgesic and antipyretic activity. Carprofen is a chiral drug.
Carprofen, like most other NSAIDs is an inhibitor of the enzyme cyclooxygenase of the arachidonic acid
cascade. However, the inhibition of prostaglandin synthesis by carprofen is slight in relation to its anti-
inflammatory and analgesic potency. The precise mode of action of carprofen is not clear.

PHARMACOKINETICS

Carprofen is rapidly and nearly completely absorbed (more than 90% bioavailable) when administered
orally. Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and
25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8
hours). Carprofen has a small volume of distribution and a low systemic clearance. It is highly bound to
plasma protein.

Carprofen is rapidly and nearly completely absorbed (more than 90% bioavailable) when administered
orally. Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and
25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8
hours). Carprofen has a small volume of distribution and a low systemic clearance. It is highly bound to
plasma protein.

Carprofen is metabolized in the liver by conjunction and oxidation. The excretion of the glycuronide
conjugate is mainly fecal after biliary excretion.
INDICATIONS:

Carodyl® is indicated for the relief of pain and inflammation associated with osteoarthritis and for the
control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

DOSAGE AND ADMINISTRATION:

For oral administration to dogs.

An initial dose of 2 to 4 mg carprofen per kg bodyweight per day in two equally divided doses. After
seven days, dose may be reduced to 2 mg per kg body weight per day as single daily dose subject to
clinical response. Long term treatment should be under veterinarian’s supervision.

To be administered with food.

CONTRAINDICATIONS:

Do not use in case of hypersensitivity to active substance or any of the excipients.

Do not use in dogs suffering from cardiac, hepatic or renal diseases.

Do not exceed the recommended dose.

WARNINGS:
All dogs should undergo a thorough history and physical examination before initiation of NSAIDs therapy.
Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to,
and periodically during, administration of any NSAIDs should be considered.

Owners should be advised to observe for signs of potential drug toxicity.

Consult a physician in cases of accidental ingestion by humans.

For oral use in dogs only. Do not use in cats.

PRECAUTIONS:

Carodyl® is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrand’s disease), as
safety has not been established in dogs with these disorders. The safe use of carprofen in animals less
than 6 weeks of age, pregnant dogs, dogs used for breeding purposes, or in lactating bitches has not
been established.

If additional pain medication is warranted after administration of the total daily dose of carprofen,
alternative analgesia should be considered. The use of another NSAIDs is not recommended. Consider
appropriate washout times when switching from one NSAIDs to another or when switching from
corticosteroid use to NSAIDs use.

Due to the palatable nature of Carodyl® chewable tablets, store out of reach of dogs in a secured
location. Severe adverse reactions may occur if large quantities of tablets are ingested. If you suspect
your dog has consumed Carodyl® chewable tablets above the labeled dose, please call your veterinarian
for immediate assistance.

PREGNANCY AND LACTATION


The safety of carprofen in pregnant or lactating animals has not been established. Do not use in pregnant
or lactating bitches.

ADVERSE REACTIONS:

Typical undesirable effects associated with NSAIDs, such as vomiting, soft faeces/diarrhea, fecal occult
blood, loss of appetite and lethargy have been reported. No clinically significant adverse reactions have
been reported. If adverse reaction occurs, use of the product should be stopped and the advice of a
veterinarian should be sought.

INFORMATION FOR DOG OWNERS:

Carprofen like other drugs of its class, is not free from adverse reactions. Owners should be advised of
the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance.
Adverse reactions may include decreased appetite, vomiting, diarrhea, dark or tarry stools, increased
water consumption, increased urination, and pale gums due to anemia, yellowing of gums, skin or white
of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. The vast majority of
patients with drug related adverse reactions have recovered when the signs are recognized, the drug is
withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance
of periodic follow up for all dogs during administration of any NSAIDs, wash hands after handling the
product.

ANIMAL SAFETY: Reported studies in unanesthetized dogs and clinical field trials have demonstrated that
Carprofen is well tolerated in dogs after oral administration.

PRESENTATION: Blister of 4 tablets, Bottle of 30 tablets and Bottle of 60 tablets

STORAGE: Store at controlled room temperature at 15 -30°C. Protect from light.

Keep out of reach of children.


Last update: August 2013.

Carprofen is rapidly and nearly completely absorbed (more than 90% bioavailable) when administered
orally. Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and
25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8
hours). Carprofen has a small volume of distribution and a low systemic clearance. It is highly bound to
plasma protein.

Carprofen is rapidly and nearly completely absorbed (more than 90% bioavailable) when administered
orally. Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and
25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8
hours). Carprofen has a small volume of distribution and a low systemic clearance. It is highly bound to
plasma protein.

Carprofen is metabolized in the liver by conjunction and oxidation. The excretion of the glycuronide
conjugate is mainly fecal after biliary excretion.

INDICATIONS:

Carodyl® is indicated for the relief of pain and inflammation associated with osteoarthritis and for the
control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

DOSAGE AND ADMINISTRATION:

For oral administration to dogs.

An initial dose of 2 to 4 mg carprofen per kg bodyweight per day in two equally divided doses. After
seven days, dose may be reduced to 2 mg per kg body weight per day as single daily dose subject to
clinical response. Long term treatment should be under veterinarian’s supervision.
To be administered with food.

CONTRAINDICATIONS:

Do not use in case of hypersensitivity to active substance or any of the excipients.

Do not use in dogs suffering from cardiac, hepatic or renal diseases.

Do not exceed the recommended dose.

WARNINGS:

All dogs should undergo a thorough history and physical examination before initiation of NSAIDs therapy.
Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to,
and periodically during, administration of any NSAIDs should be considered.

Owners should be advised to observe for signs of potential drug toxicity.

Consult a physician in cases of accidental ingestion by humans.

For oral use in dogs only. Do not use in cats.

PRECAUTIONS:

Carodyl® is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrand’s disease), as
safety has not been established in dogs with these disorders. The safe use of carprofen in animals less
than 6 weeks of age, pregnant dogs, dogs used for breeding purposes, or in lactating bitches has not
been established.

If additional pain medication is warranted after administration of the total daily dose of carprofen,
alternative analgesia should be considered. The use of another NSAIDs is not recommended. Consider
appropriate washout times when switching from one NSAIDs to another or when switching from
corticosteroid use to NSAIDs use.

Due to the palatable nature of Carodyl® chewable tablets, store out of reach of dogs in a secured
location. Severe adverse reactions may occur if large quantities of tablets are ingested. If you suspect
your dog has consumed Carodyl® chewable tablets above the labeled dose, please call your veterinarian
for immediate assistance.

PREGNANCY AND LACTATION

The safety of carprofen in pregnant or lactating animals has not been established. Do not use in pregnant
or lactating bitches.

ADVERSE REACTIONS:

Typical undesirable effects associated with NSAIDs, such as vomiting, soft faeces/diarrhea, fecal occult
blood, loss of appetite and lethargy have been reported. No clinically significant adverse reactions have
been reported. If adverse reaction occurs, use of the product should be stopped and the advice of a
veterinarian should be sought.

INFORMATION FOR DOG OWNERS:

Carprofen like other drugs of its class, is not free from adverse reactions. Owners should be advised of
the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance.
Adverse reactions may include decreased appetite, vomiting, diarrhea, dark or tarry stools, increased
water consumption, increased urination, and pale gums due to anemia, yellowing of gums, skin or white
of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. The vast majority of
patients with drug related adverse reactions have recovered when the signs are recognized, the drug is
withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance
of periodic follow up for all dogs during administration of any NSAIDs, wash hands after handling the
product.

ANIMAL SAFETY: Reported studies in unanesthetized dogs and clinical field trials have demonstrated that
Carprofen is well tolerated in dogs after oral administration.

PRESENTATION: Blister of 4 tablets, Bottle of 30 tablets and Bottle of 60 tablets

STORAGE: Store at controlled room temperature at 15 -30°C. Protect from light.

Keep out of reach of children.

CARODYL®

Carprofen chewable tablets

COMPOSITION:

Each chewable tablet contains:

Carprofen 75 mg

Excipients q.s.
CHEMISTRY: 6-chloro-α-methyl-9H-carbazole-2-acetic acid.

CATEGORY: Non – steroidal anti-inflammatory drug

DESCRIPTION: Carodyl® (Carprofen) is a non-steroidal anti-inflammatory drug (NSAIDs) of the propionic


acid class that includes ibuprofen, naproxen and ketoprofen. Carprofen is the nonproprietary designation
for a substituted carbazole.

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

Carprofen is a member of the 2-arylpropionic acid group of non-steroidal anti-inflammatory drugs


(NSAIDs), and possesses anti-inflammatory, analgesic and antipyretic activity. Carprofen is a chiral drug.
Carprofen, like most other NSAIDs is an inhibitor of the enzyme cyclooxygenase of the arachidonic acid
cascade. However, the inhibition of prostaglandin synthesis by carprofen is slight in relation to its anti-
inflammatory and analgesic potency. The precise mode of action of carprofen is not clear.

PHARMACOKINETICS

Carprofen is rapidly and nearly completely absorbed (more than 90% bioavailable) when administered
orally. Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and
25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8
hours). Carprofen has a small volume of distribution and a low systemic clearance. It is highly bound to
plasma protein.

Carprofen is metabolized in the liver by conjunction and oxidation. The excretion of the glycuronide
conjugate is mainly fecal after biliary excretion.
INDICATIONS:

Carodyl® is indicated for the relief of pain and inflammation associated with osteoarthritis and for the
control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

DOSAGE AND ADMINISTRATION:

For oral administration to dogs.

An initial dose of 2 mg to 4 mg carprofen per kg bodyweight per day in two equally divided doses. After
seven days, dose may be reduced to 2 mg per kg bodyweight per day as single daily dose subject to
clinical response. Long term treatment should be under veterinarian’s supervision.

Weight

Tablet size

Dose

Dosage
7.1 – 10 kg

75 mg

37.5 mg

½ tab

14.1 – 18 kg

75 mg

75 mg

1tab

To be administered with food

CONTRAINDICATIONS:

Carodyl® should not be used in dogs exhibiting previous hypersensitivity to carprofen.


Do not use in dogs suffering from cardiac, hepatic or renal diseases.

Do not exceed the recommended dose.

WARNINGS:

All dogs should undergo a thorough history and physical examination before initiation of NSAIDs therapy.
Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to,
and periodically during, administration of any NSAIDs should be considered.

Owners should be advised to observe for signs of potential drug toxicity.

Consult a physician in cases of accidental ingestion by humans.

For use in dogs only. Do not use in cats.

PRECAUTIONS:

Carodyl® is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrand’s disease), as
safety has not been established in dogs with these disorders. The safe use of Carodyl® in animals less
than 6 weeks of age, pregnant dogs, dogs used for breeding purposes, or in lactating bitches has not
been established.
If additional pain medication is warranted after administration of the total daily dose of carprofen,
alternative analgesia should be considered. The use of another NSAIDs is not recommended. Consider
appropriate washout times when switching from one NSAIDs to another or when switching from
corticosteroid use to NSAIDs use.

Due to the palatable nature of Carodyl® chewable tablets, store out of reach of dogs in a secured
location. Severe adverse reactions may occur if large quantities of tablets are ingested. If you suspect
your dog has consumed Carodyl® chewable tablets above the labeled dose, please call your veterinarian
for immediate assistance.

PREGNANCY AND LACTATION

The safety of carprofen in pregnant or lactating animals has not been established. Do not use in pregnant
or lactating bitches.

ADVERSE REACTIONS:

Typical undesirable effects associated with NSAIDs, such as vomiting, soft faeces/diarrhea, fecal occult
blood, loss of appetite and lethargy have been reported. No clinically significant adverse reactions have
been reported. If adverse reaction occurs, use of the product should be stopped and the advice of a
veterinarian should be sought.
INFORMATION FOR DOG OWNERS:

Carodyl®, like other drugs of its class, is not free from adverse reactions. Owners should be advised of
the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance.
Adverse reactions may include decreased appetite, vomiting, diarrhea, dark or tarry stools, increased
water consumption, increased urination, and pale gums due to anemia, yellowing of gums, skin or white
of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. The vast majority of
patients with drug related adverse reactions have recovered when the signs are recognized, the drug is
withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance
of periodic follow up for all dogs during administration of any NSAIDs, wash hands after handling the
product.

ANIMAL SAFETY: Reported studies in unanesthetized dogs and clinical field trials have demonstrated that
Carodyl® is well tolerated in dogs after oral administration.

PRESENTATION: bottle of 30 tabs

STORAGE: Store in cool and dry place. Protect from direct sunlight.

Keep out of reach of children.

For oral use in dogs only.

CARODYL®

Carprofen chewable tablets


COMPOSITION:

Each chewable tablet contains:

Carprofen 100 mg

Excipients q.s.

CHEMISTRY: 6-chloro-α-methyl-9H-carbazole-2-acetic acid.

CATEGORY: Non – steroidal anti-inflammatory drug

DESCRIPTION: Carodyl® (Carprofen) is a non-steroidal anti-inflammatory drug (NSAIDs) of the propionic


acid class that includes ibuprofen, naproxen and ketoprofen. Carprofen is the nonproprietary designation
for a substituted carbazole.

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

Carprofen is a member of the 2-arylpropionic acid group of non-steroidal anti-inflammatory drugs


(NSAIDs), and possesses anti-inflammatory, analgesic and antipyretic activity. Carprofen is a chiral drug.
Carprofen, like most other NSAIDs is an inhibitor of the enzyme cyclooxygenase of the arachidonic acid
cascade. However, the inhibition of prostaglandin synthesis by carprofen is slight in relation to its anti-
inflammatory and analgesic potency. The precise mode of action of carprofen is not clear.

PHARMACOKINETICS
Carprofen is rapidly and nearly completely absorbed (more than 90% bioavailable) when administered
orally. Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and
25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8
hours). Carprofen has a small volume of distribution and a low systemic clearance. It is highly bound to
plasma protein.

Carprofen is metabolized in the liver by conjunction and oxidation. The excretion of the glycuronide
conjugate is mainly fecal after biliary excretion.

INDICATIONS:

Carodyl® is indicated for the relief of pain and inflammation associated with osteoarthritis and for the
control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

DOSAGE AND ADMINISTRATION:

For oral administration to dogs.

An initial dose of 2 mg to 4 mg carprofen per kg bodyweight per day in two equally divided doses. After
seven days, dose may be reduced to 2 mg per kg bodyweight per day as single daily dose subject to
clinical response. Long term treatment should be under veterinarian’s supervision.
Weight

Tablet size

Dose

Dosage

10.1 – 14 kg

100 mg

50 mg

½ tab

18.1 – 27 kg

100 mg

100 mg

1tab
27.1 – 41 kg

100 mg

150 mg

1½ tabs

41.1 – 55 kg

100 mg

200 mg

2 tabs

To be administered with food

CONTRAINDICATIONS:
Carodyl® should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Do not use in dogs suffering from cardiac, hepatic or renal diseases.

Do not exceed the recommended dose.

WARNINGS:

All dogs should undergo a thorough history and physical examination before initiation of NSAIDs therapy.
Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to,
and periodically during, administration of any NSAIDs should be considered.

Owners should be advised to observe for signs of potential drug toxicity.

Consult a physician in cases of accidental ingestion by humans.

For use in dogs only. Do not use in cats.

PRECAUTIONS:

Carodyl® is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrand’s disease), as
safety has not been established in dogs with these disorders. The safe use of Carodyl® in animals less
than 6 weeks of age, pregnant dogs, dogs used for breeding purposes, or in lactating bitches has not
been established.

If additional pain medication is warranted after administration of the total daily dose of carprofen,
alternative analgesia should be considered. The use of another NSAIDs is not recommended. Consider
appropriate washout times when switching from one NSAIDs to another or when switching from
corticosteroid use to NSAIDs use.

Due to the palatable nature of Carodyl® chewable tablets, store out of reach of dogs in a secured
location. Severe adverse reactions may occur if large quantities of tablets are ingested. If you suspect
your dog has consumed Carodyl® chewable tablets above the labeled dose, please call your veterinarian
for immediate assistance.

PREGNANCY AND LACTATION

The safety of carprofen in pregnant or lactating animals has not been established. Do not use in pregnant
or lactating bitches.

ADVERSE REACTIONS:

Typical undesirable effects associated with NSAIDs, such as vomiting, soft faeces/diarrhea, fecal occult
blood, loss of appetite and lethargy have been reported. No clinically significant adverse reactions have
been reported. If adverse reaction occurs, use of the product should be stopped and the advice of a
veterinarian should be sought.
INFORMATION FOR DOG OWNERS:

Carodyl®, like other drugs of its class, is not free from adverse reactions. Owners should be advised of
the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance.
Adverse reactions may include decreased appetite, vomiting, diarrhea, dark or tarry stools, increased
water consumption, increased urination, and pale gums due to anemia, yellowing of gums, skin or white
of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. The vast majority of
patients with drug related adverse reactions have recovered when the signs are recognized, the drug is
withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance
of periodic follow up for all dogs during administration of any NSAIDs, wash hands after handling the
product.

ANIMAL SAFETY: Reported studies in unanesthetized dogs and clinical field trials have demonstrated that
Carodyl® is well tolerated in dogs after oral administration.

PRESENTATION: Bottle of 30 tabs

STORAGE: Store in cool and dry place. Protect from direct sunlight.

Keep out of reach of children.

For oral use in dogs only.

Carodyl 25mg Tablet

COMPOSITION:
Carprofen chewable tablets-25 mg

CATEGORY: Non – steroidal anti-inflammatory drug

For oral use in dogs only

DESCRIPTION: Carodyl (carprofen) is a non-steroidal anti-inflammatory drug (NSAID) of the propionic


acid class that includes ibuprofen, naproxen and ketoprofen. Carprofen is the nonproprietary designation
for a substituted carbazole, 6-chloro-α-methyl-9H-carbazole-2-acetic acid.

CLINICAL PHARMACOLOGY

Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent with characteristic analgesic and


antipyretic activity approximately equipotent to indomethacin in animal models.1

The mechanism of action of carprofen, like that of other NSAIDs, is believed to be associated with the
inhibition of cyclooxygenase activity. Two unique cyclooxygenases have been described in mammals. The
constitutive cyclooxygenase, COX-1, synthesizes prostaglandins necessary for normal gastrointestinal and
renal function. The inducible cyclooxygenase, COX-2, generates prostaglandins involved in inflammation.
Inhibition of COX-1 is thought to be associated with gastrointestinal and renal toxicity while inhibition of
COX-2 provides anti-inflammatory activity. The specificity of a particular NSAID for COX-2 versus COX-1
may vary from species to species. Carprofen has also been shown to inhibit the release of several
prostaglandins in two inflammatory cell systems: rat polymorphonuclear leukocytes (PMN) and human
rheumatoid synovial cells, indicating inhibition of acute (PMN system) and chronic (synovial cell system)
inflammatory reactions.

Several studies have reported that carprofen has modulatory effects on both humoral and cellular
immune responses. Data also indicate that carprofen inhibits the production of osteoclast-activating
factor (OAF), PGE1, and PGE2 by its inhibitory effect in prostaglandin biosynthesis.
Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and 25
mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8 hours)
after single oral doses varying from 1-35 mg/kg of body weight. After a 100 mg single intravenous bolus
dose, the mean elimination half-life was approximately 11.7 hours in the dog. Carprofen is more than
99% bound to plasma protein and exhibits a very small volume of distribution.

Carprofen is eliminated in the dog primarily by biotransformation in the liver followed by rapid excretion
of the resulting metabolites (the ester glucuronide of carprofen and the ether glucuronides of 2 phenolic
metabolites, 7-hydroxy carprofen and 8-hydroxy carprofen) in the feces (70-80%) and urine (10-20%).
Some enterohepatic circulation of the drug is observed.

INDICATIONS: Carodyl is indicated for the relief of pain and inflammation associated with osteoarthritis
and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

DOSAGE AND ADMINISTRATION: Always provide Client Information Sheet with prescription. Carefully
consider the potential benefits and risk of Carodyl and other treatment options before deciding to use
Carodyl. Use the lowest effective dose for the shortest duration consistent with individual response. The
recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily
dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb
twice daily. For the control of postoperative pain, administer approximately 2 hours before the
procedure. Carodyl chewable tablets are scored and dosage should be calculated in half-tablet
increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both
sides of the score. Carodyl chewable tablets are palatable and willingly consumed by most dogs when
offered by the owner. Therefore, they may be fed by hand or placed on food. Care should be taken to
ensure that the dog consumes the complete dose.

CONTRAINDICATIONS: Carodyl should not be used in dogs exhibiting previous hypersensitivity to


carprofen.

WARNINGS:
Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by
humans. For use in dogs only. Do not use in cats.

All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy.
Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to,
and periodically during, administration of any NSAID should be considered.

Owners should be advised to observe for signs of potential drug toxicity

PRECAUTIONS:

Carodyl is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrand’s disease), as
safety has not been established in dogs with these disorders. The safe use of Carodyl in animals less than
6 weeks of age, pregnant dogs, dogs used for breeding purposes, or in lactating bitches has not been
established. Studies to determine the activity of Carodyl when administered concomitantly with other
protein-bound or similarly metabolized drugs have not been conducted. Drug compatibility should be
monitored closely in patients requiring additional therapy. Such drugs commonly used include cardiac,
anticonvulsant and behavioral medications. It has been suggested that treatment with carprofen may
reduce the level of inhalant anesthetics needed.

If additional pain medication is warranted after administration of the total daily dose of Carodyl,
alternative analgesia should be considered. The use of another NSAID is not recommended. Consider
appropriate washout times when switching from one NSAID to another or when switching from
corticosteroid use to NSAID use.

Due to the palatable nature of Carodyl chewable tablets, store out of reach of dogs in a secured location.
Severe adverse reactions may occur if large quantities of tablets are ingested. If you suspect your dog has
consumed Carodyl chewable tablets above the labeled dose, please call your veterinarian for immediate
assistance.

INFORMATION FOR DOG OWNERS:


Carodyl, like other drugs of its class, is not free from adverse reactions. Owners should be advised of the
potential for adverse reactions and be informed of the clinical signs associated with drug intolerance.
Adverse reactions may include decreased appetite, vomiting, diarrhea, dark or tarry stools, increased
water consumption, increased urination, pale gums due to anemia, yellowing of gums, skin or white of
the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. The vast majority of
patients with drug related adverse reactions have recovered when the signs are recognized, the drug is
withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance
of periodic follow up for all dogs during administration of any NSAID.

ANIMAL SAFETY: Laboratory studies in unanesthetized dogs and clinical field trials have demonstrated
that Carodyl is well tolerated in dogs after oral administration.

PRESENTATION: Carodyl chewable tablets contain 25 mg of carprofen per tablet in pack of 4 tablet in
Strip.

STORAGE: Store below 30o C. Protect from direct sunlight.

For the use only of a Veterinary Medical Practitioner only, Hospital or Laboratory or a Farm

Carodyl 100 mg Tablet

COMPOSITION:

Carprofen chewable tablets-100 mg

CATEGORY: Non – steroidal anti-inflammatory drug


For oral use in dogs only

DESCRIPTION: Carodyl (carprofen) is a non-steroidal anti-inflammatory drug (NSAID) of the propionic


acid class that includes ibuprofen, naproxen and ketoprofen. Carprofen is the nonproprietary designation
for a substituted carbazole, 6-chloro-α-methyl-9H-carbazole-2-acetic acid.

CLINICAL PHARMACOLOGY

Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent with characteristic analgesic and


antipyretic activity approximately equipotent to indomethacin in animal models.1

The mechanism of action of carprofen, like that of other NSAIDs, is believed to be associated with the
inhibition of cyclooxygenase activity. Two unique cyclooxygenases have been described in mammals. The
constitutive cyclooxygenase, COX-1, synthesizes prostaglandins necessary for normal gastrointestinal and
renal function. The inducible cyclooxygenase, COX-2, generates prostaglandins involved in inflammation.
Inhibition of COX-1 is thought to be associated with gastrointestinal and renal toxicity while inhibition of
COX-2 provides anti-inflammatory activity. The specificity of a particular NSAID for COX-2 versus COX-1
may vary from species to species. Carprofen has also been shown to inhibit the release of several
prostaglandins in two inflammatory cell systems: rat polymorphonuclear leukocytes (PMN) and human
rheumatoid synovial cells, indicating inhibition of acute (PMN system) and chronic (synovial cell system)
inflammatory reactions.

Several studies have reported that carprofen has modulatory effects on both humoral and cellular
immune responses. Data also indicate that carprofen inhibits the production of osteoclast-activating
factor (OAF), PGE1, and PGE2 by its inhibitory effect in prostaglandin biosynthesis.

Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and 25
mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8 hours)
after single oral doses varying from 1-35 mg/kg of body weight. After a 100 mg single intravenous bolus
dose, the mean elimination half-life was approximately 11.7 hours in the dog. Carprofen is more than
99% bound to plasma protein and exhibits a very small volume of distribution.
Carprofen is eliminated in the dog primarily by biotransformation in the liver followed by rapid excretion
of the resulting metabolites (the ester glucuronide of carprofen and the ether glucuronides of 2 phenolic
metabolites, 7-hydroxy carprofen and 8-hydroxy carprofen) in the feces (70-80%) and urine (10-20%).
Some enterohepatic circulation of the drug is observed.

INDICATIONS: Carodyl is indicated for the relief of pain and inflammation associated with osteoarthritis
and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

DOSAGE AND ADMINISTRATION: Always provide Client Information Sheet with prescription. Carefully
consider the potential benefits and risk of Carodyl and other treatment options before deciding to use
Carodyl. Use the lowest effective dose for the shortest duration consistent with individual response. The
recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily
dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb
twice daily. For the control of postoperative pain, administer approximately 2 hours before the
procedure. Carodyl chewable tablets are scored and dosage should be calculated in half-tablet
increments. Tablets can be halved by placing the tablet on a hard surface and pressing down on both
sides of the score. Carodyl chewable tablets are palatable and willingly consumed by most dogs when
offered by the owner. Therefore, they may be fed by hand or placed on food. Care should be taken to
ensure that the dog consumes the complete dose.

CONTRAINDICATIONS: Carodyl should not be used in dogs exhibiting previous hypersensitivity to


carprofen.

WARNINGS:

Keep out of reach of children. Not for human use. Consult a physician in cases of accidental ingestion by
humans. For use in dogs only. Do not use in cats.

All dogs should undergo a thorough history and physical examination before initiation of NSAID therapy.
Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to,
and periodically during, administration of any NSAID should be considered.
Owners should be advised to observe for signs of potential drug toxicity

PRECAUTIONS:

Carodyl is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrand’s disease), as
safety has not been established in dogs with these disorders. The safe use of Carodyl in animals less than
6 weeks of age, pregnant dogs, dogs used for breeding purposes, or in lactating bitches has not been
established. Studies to determine the activity of Carodyl when administered concomitantly with other
protein-bound or similarly metabolized drugs have not been conducted. Drug compatibility should be
monitored closely in patients requiring additional therapy. Such drugs commonly used include cardiac,
anticonvulsant and behavioral medications. It has been suggested that treatment with carprofen may
reduce the level of inhalant anesthetics needed.

If additional pain medication is warranted after administration of the total daily dose of Carodyl,
alternative analgesia should be considered. The use of another NSAID is not recommended. Consider
appropriate washout times when switching from one NSAID to another or when switching from
corticosteroid use to NSAID use.

Due to the palatable nature of Carodyl chewable tablets, store out of reach of dogs in a secured location.
Severe adverse reactions may occur if large quantities of tablets are ingested. If you suspect your dog has
consumed Carodyl chewable tablets above the labeled dose, please call your veterinarian for immediate
assistance.

INFORMATION FOR DOG OWNERS:

Carodyl, like other drugs of its class, is not free from adverse reactions. Owners should be advised of the
potential for adverse reactions and be informed of the clinical signs associated with drug intolerance.
Adverse reactions may include decreased appetite, vomiting, diarrhea, dark or tarry stools, increased
water consumption, increased urination, pale gums due to anemia, yellowing of gums, skin or white of
the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. The vast majority of
patients with drug related adverse reactions have recovered when the signs are recognized, the drug is
withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance
of periodic follow up for all dogs during administration of any NSAID.

ANIMAL SAFETY: Laboratory studies in unanesthetized dogs and clinical field trials have demonstrated
that Carodyl is well tolerated in dogs after oral administration.

PRESENTATION: Carodyl chewable tablets contain 100 mg of carprofen per tablet in pack of 4 tablet in
Strip.

STORAGE: Store below 30o C. Protect from direct sunlight.

For the use only of a Veterinary Medical Practitioner only, Hospital or Laboratory or a Farm

CARODYL®

Carprofen chewable tablets

COMPOSITION:

Each chewable tablet contains:

Carprofen 25 mg

Excipients q.s.

CHEMISTRY: 6-chloro-α-methyl-9H-carbazole-2-acetic acid.


CATEGORY: Non – steroidal anti-inflammatory drug

DESCRIPTION: Carodyl® (Carprofen) is a non-steroidal anti-inflammatory drug (NSAIDs) of the propionic


acid class that includes ibuprofen, naproxen and ketoprofen. Carprofen is the nonproprietary designation
for a substituted carbazole.

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

Carprofen is a member of the 2-arylpropionic acid group of non-steroidal anti-inflammatory drugs


(NSAIDs), and possesses anti-inflammatory, analgesic and antipyretic activity. Carprofen is a chiral drug.
Carprofen, like most other NSAIDs is an inhibitor of the enzyme cyclooxygenase of the arachidonic acid
cascade. However, the inhibition of prostaglandin synthesis by carprofen is slight in relation to its anti-
inflammatory and analgesic potency. The precise mode of action of carprofen is not clear.

PHARMACOKINETICS

Carprofen is rapidly and nearly completely absorbed (more than 90% bioavailable) when administered
orally. Peak blood plasma concentrations are achieved in 1-3 hours after oral administration of 1, 5, and
25 mg/kg to dogs. The mean terminal half-life of carprofen is approximately 8 hours (range 4.5-9.8
hours). Carprofen has a small volume of distribution and a low systemic clearance. It is highly bound to
plasma protein.

Carprofen is metabolized in the liver by conjunction and oxidation. The excretion of the glycuronide
conjugate is mainly fecal after biliary excretion.
INDICATIONS:

Carodyl® is indicated for the relief of pain and inflammation associated with osteoarthritis and for the
control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.

DOSAGE AND ADMINISTRATION:

For oral administration to dogs.

An initial dose of 2 mg to 4 mg carprofen per kg bodyweight per day in two equally divided doses. After
seven days, dose may be reduced to 2 mg per kg bodyweight per day as single daily dose subject to
clinical response. Long term treatment should be under veterinarian’s supervision.

Weight

Tablet size

Dose

Dosage
2 – 5 kg

25 mg

12.5 mg

½ tab

5.1 – 7 kg

25 mg

25 mg

1 tab

To be administered with food

CONTRAINDICATIONS:

Carodyl® should not be used in dogs exhibiting previous hypersensitivity to carprofen.


Do not use in dogs suffering from cardiac, hepatic or renal diseases.

Do not exceed the recommended dose.

WARNINGS:

All dogs should undergo a thorough history and physical examination before initiation of NSAIDs therapy.
Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to,
and periodically during, administration of any NSAIDs should be considered.

Owners should be advised to observe for signs of potential drug toxicity.

Consult a physician in cases of accidental ingestion by humans.

For use in dogs only. Do not use in cats.

PRECAUTIONS:

Carodyl® is not recommended for use in dogs with bleeding disorders (e.g., Von Willebrand’s disease), as
safety has not been established in dogs with these disorders. The safe use of Carodyl® in animals less
than 6 weeks of age, pregnant dogs, dogs used for breeding purposes, or in lactating bitches has not
been established.
If additional pain medication is warranted after administration of the total daily dose of carprofen,
alternative analgesia should be considered. The use of another NSAIDs is not recommended. Consider
appropriate washout times when switching from one NSAIDs to another or when switching from
corticosteroid use to NSAIDs use.

Due to the palatable nature of Carodyl® chewable tablets, store out of reach of dogs in a secured
location. Severe adverse reactions may occur if large quantities of tablets are ingested. If you suspect
your dog has consumed Carodyl® chewable tablets above the labeled dose, please call your veterinarian
for immediate assistance.

PREGNANCY AND LACTATION

The safety of carprofen in pregnant or lactating animals has not been established. Do not use in pregnant
or lactating bitches.

ADVERSE REACTIONS:

Typical undesirable effects associated with NSAIDs, such as vomiting, soft faeces/diarrhea, fecal occult
blood, loss of appetite and lethargy have been reported. No clinically significant adverse reactions have
been reported. If adverse reaction occurs, use of the product should be stopped and the advice of a
veterinarian should be sought.
INFORMATION FOR DOG OWNERS:

Carodyl®, like other drugs of its class, is not free from adverse reactions. Owners should be advised of
the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance.
Adverse reactions may include decreased appetite, vomiting, diarrhea, dark or tarry stools, increased
water consumption, increased urination, and pale gums due to anemia, yellowing of gums, skin or white
of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. The vast majority of
patients with drug related adverse reactions have recovered when the signs are recognized, the drug is
withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance
of periodic follow up for all dogs during administration of any NSAIDs, wash hands after handling the
product.

ANIMAL SAFETY: Reported studies in unanesthetized dogs and clinical field trials have demonstrated that
Carodyl® is well tolerated in dogs after oral administration.

PRESENTATION: Bottle of 30 tabs

STORAGE: Store in cool and dry place. Protect from direct sunlight.

Keep out of reach of children.

For oral use in dogs only.

Details

Praziquantel, Pyrantel Pamoate and Febantel Tablets

KIWOF™ PLUS XL
For Dogs

COMPOSITION:

KIWOF™ PLUS XL FOR DOGS

Each chewable tablet contains:

Praziquantel IP 175 mg

Pyrantel Pamoate IP 504 mg

Febantel 525 mg

Excipients q.s.

PHARMACOLOGY

KIWOF™ PLUS XL Tablets contain three active ingredients having different modes of action and spectra of
activity. Praziquantel is active against cestodes (tapeworms). Praziquantel is absorbed, metabolized in
the liver and excreted in the bile. Upon entering the digestive tract from the bile, cestocidal activity is
exhibited. Following exposure to praziquantel, the tapeworm loses its ability to resist digestion by the
mammalian host. Because of this, whole tapeworms, including the scolices, are very rarely passed after
administration of praziquantel. In many instances only disintegrated and partially digested pieces of
tapeworms will be seen in the stool. The majorities of tapeworms are digested and are not found in the
feces.
Pyrantel pamoate is active against hookworms and ascarids. Pyrantel pamoate acts on the cholinergic
receptors of the nematode resulting in spastic paralysis. Peristaltic action of the intestinal tract then
eliminates the parasite.

Febantel is active against nematode parasites including whipworms. Febantel is rapidly absorbed and
metabolized in the animal.

Available information suggests that the parasite’s energy metabolism is blocked, leading to energy
exchange breakdown and inhibited glucose uptake.

INDICATIONS:

KIWOF™ PLUS XL Tablets are indicated for removal of Tapeworms (Dipylidium caninum, Taenia pisiformis,
Echinococcus granulosus and removal and control of Echincoccus multilocularis). For removal of
Hookworms (Ancylostoma caninum, Uncinaria stenocephala), Ascarids (Toxocara canis, Toxascaris
leonina) and Whipworms (Trichuris vulpis) in dogs.

DOSAGE AND ADMINISTRATION:

For oral administration only.

The tablets can be given directly to the dog or disguised in food. No starvation is needed before or after
treatment.
- For routine control adult dogs should be treated every 3 months. For routine treatment a single dose is
recommended. In the event of heavy roundworm infestation a repeat dose should be given after 14
days.

KIWOF™ PLUS XL TABLETS DOSAGE GUIDE: FOR DOGS

17.5 kg body weight = ½ KIWOF™ PLUS XL Tablet

Over17.5 kg upto 35 kg body weight = 1 KIWOF™ PLUS XL Tablet

Over 35 kg upto 52.5 kg body weight = 1 ½ KIWOF™ PLUS XL Tablets

Over 52.5 kg upto 70 kg body weight = 2 KIWOF™ PLUS XL Tablets

- For routine treatment a single dose is recommended.

PREGNANCY AND LACTATION:

- Consult a veterinary surgeon before treating pregnant animals for roundworms.

- The product may be used during lactation.

- Do not exceed recommended dose when treating pregnant bitches.

CONTRA-INDICATIONS, WARNINGS, ETC:


Do not use simultaneously with piperazine compounds.

USER SAFETY:

In the interests of good hygiene, persons administering the tablets directly to the dog, or by adding them
to the dog’s food, should wash their hands afterwards.

ENVIRONMENTAL SAFETY:

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
product should be disposed of in accordance with local requirements.

PRECAUTIONS:

Strict hygienic precautions should be taken when handling dogs or feces suspected of harboring E.
multilocularis. Infected dogs treated for the first time with KIWOF™ PLUS XL Tablets and dogs treated at
intervals greater than 28 days may shed eggs in the feces after treatment. The animal should be held in
the clinic during this interval and all feces should be incinerated or autoclaved. If these procedures are
not possible, the eggs can be destroyed by soaking the feces in a sodium hypochlorite (bleach) solution
of 3.75% or greater. All areas where the animal was maintained or in contact with should be thoroughly
cleaned with sodium hypochlorite and allowed to dry completely before reuse.
KIWOF™ PLUS XL Tablets should be used alone and never combined with other de-worming medicine.

ADVERSE DRUG REACTIONS:

None reported. Vomiting was reported in some cases.

PRESENTATION: Blister of 4 Tablets.

STORAGE: Store in cool and dry place. Protect from Light. Keep out of reach of children.

Veterinary

Not for human use

For treatment of animals only

KIWOF PUPPY SUSPENSION

Pyrantel Pamoate and Febantel suspension

COMPOSITION:
Each ml contains:

Pyrantel Pamoate 14.4 mg

Febantel 15 mg

PHARMACOLOGY:

Pyrantel pamoate is active against hookworms and ascarids (roundworms). Pyrantel pamoate acts on the
cholinergic receptors of the nematode resulting in spastic paralysis. Peristaltic action of the intestinal
tract then eliminates the parasite. In this fixed combination product, the pyrantel and febantel act
synergistically against nematodes (ascarids, hookworms and whipworms) of dogs. In particular, the
spectrum of activity covers Toxocara canis, Ancylostoma caninum and Trichuris vulpis.

INDICATIONS:

For the treatment of roundworm infections in puppies and young dogs up to one year of age caused by:

Ascarids

Toxocara canis, Toxascaris leonina

Hookworm
Ancylostoma caninum, Uncinaria stenocephala

Whipworm

Trichuris vulpis

DOSAGE AND ADMINISTRATION:

The dose is 1 ml suspension per kg bodyweight,

Every two weeks till 3 months of age,

Every month from 3 to 6 months of age and

Every 3 months after age of 6 months.

Administration is by the oral route. The product may be given directly to the puppy or mixed with the
feed. No special dietary measures are necessary.
It is recommended that treatment should be started at 2 weeks of age and should be performed
repeatedly at suitable intervals (for example every two weeks) until weaning

CONTRAINDICATIONS, WARNINGS, ETC:

Do not use simultaneously with compounds containing piperazine.

Parasite resistance to any particular class of anthelmintic may develop following frequent repeated use
of an anthelmintic of that class.

The safety of the product has not been assessed in puppies younger than 2 weeks and weighing less
than 0.6 kg.

In very rare cases mild transient digestive tract signs (e.g., vomiting, diarrhoea) may occur.

The anthelmintic effects of both pyrantel (spastic paralysis) and piperazine (neuromuscular paralysis)
may be antagonised when the two drugs are used together.

User safety

Wash hands after use.

Avoid direct contact with the skin and eyes.


In case of accidental spillage wash the affected area immediately with clean running water.

Environmental safety

Any unused product or waste materials should be disposed of in accordance with national requirements.

Use during Pregnancy and Lactation

This product is contra-indicated for pregnant and lactating bitches.

Side Effects

The side effects are rare at the recommended dosage. It has a wide margin of safety for all sizes and
breeds of dogs. It is approved for use in puppies as young as 2 weeks of age and may be combined with
other treatments, for example heartworm prevention, flea and tick treatments, vaccination.

PRESENTATION: Bottle (15 ml)


Details

COMPOSITION:

Small Dogs:

Each Chewable tablet contains:

Ivermectin BP 68 mcg

Pyrantel Pamoate USP

Equivalent to Pyrantel 57 mg

Excipients q.s.

Medium Dogs:

Each Chewable tablet contains:

Ivermectin BP 136 mcg

Pyrantel Pamoate USP

Equivalent to Pyrantel 114 mg


Excipients q.s.

Large Dogs:

Each Chewable tablet contains:

Ivermectin BP 272 mcg

Pyrantel Pamoate USP

Equivalent to Pyrantel 227 mg

Excipients q.s.

INDICATIONS

For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae
(Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of ascarids
(Toxocara canis, Toxascaris leonina) and hookworms

(Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense).

DOSAGE

KIWOF HART should be administered orally at monthly intervals at the recommended minimum dose
level of 6 mcg of ivermectin per kilogram (2.72 mcg/lb) and 5 mg of pyrantel (as pamoate salt) per kg
(2.27 mg/lb) of body weight. The recommended dosing schedule for prevention of canine heartworm
disease and for the treatment and control of ascarids and hookworms is as follows:

Dog Weight Chewable Tablet Ivermectin Pyrantel

(Kg) Per Month Content Content

Upto 11 1 68 mcg 57 mg

12 to 22 1 136 mcg 114 mg

23 to 45 1 272 mcg 227 mg

KIWOF HART is recommended for dogs 6 weeks of age and older.

For dogs over 100 lb (45kg) use the appropriate combination of these Chewable Tablets.

ADMINISTRATION

Remove only one Chewable Tablet at a time from the foil-backed blister card. Return the card with the
remaining Chewable Tablets to its box to protect the product from light. Because most dogs find KIWOF
HART palatable, the product can be offered to the dog by hand. Alternatively, it may be added intact to a
small amount of dog food. The Chewable Tablet should be administered in a manner that encourages the
dog to chew, rather than to swallow without chewing. Chewable Tablets may be broken into pieces and
fed to dogs that normally swallow treats whole.

Care should be taken that the dog consumes the complete dose, and treated animals should be
observed for a few minutes after administration to ensure that part of the dose is not lost or rejected. If
it is suspected that any of the doses has been lost, re-dosing is recommended.
KIWOF HART should be given at monthly intervals during the period of the year when mosquitoes
(vectors), potentially carrying infective heartworm larvae, are active. The initial dose must be given
within a month (30 days) after the dog's first exposure to mosquitoes. The final dose must be given
within a month (30 days) after the dog's last exposure to mosquitoes.

When replacing another heartworm preventive product in a heartworm disease preventive program, the
first dose of KIWOF HART must be given within a month (30 days) of the last dose of the former
medication.

If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be reduced.
Therefore, for optimal performance, the chewable tablet must be given once a month on or about the
same day of the month. If treatment is delayed, whether by a few days or many, immediate treatment
with KIWOF HART and resumption of the recommended dosing regimen minimizes the opportunity for
the development of adult heartworms.

Monthly treatment with KIWOF HART also provides effective treatment and control of ascarids (T. canis,
T. leonina) and hookworms (A. caninum, U. stenocephala, A. braziliense). Clients should be advised of
measures to be taken to prevent reinfection with intestinal parasites.

EFFICACY

KIWOF HART (ivermectin/pyrantel) Chewable Tablets, given orally using the recommended dose and
regimen, are effective against the tissue larval stage of D. immitis for a month (30 days) after infection
and, as a result, prevent the development of the adult stage.

KIWOF HART Chewable Tablets are also effective against canine ascarids (T. canis, T. leonina) and
hookworms (A. caninum, U. stenocephala, A. braziliense).

PRECAUTIONS
All dogs should be tested for existing heartworm infection before starting treatment with KIWOF HART
which is not effective against adult D. immitis. Infected dogs must be treated to remove adult
heartworms and microfilariae before initiating a program with KIWOF HART.

While some microfilariae may be killed by the ivermectin in KIWOF HART at the recommended dose
level, KIWOF HART is not effective for microfilariae clearance. A mild hypersensitivity-type reaction,
presumably due to dead or dying microfilariae and particularly involving a transient diarrhea, has been
observed in clinical trials with ivermectin alone after treatment of some dogs that have circulating
microfilariae.

Keep out of the reach of children. In case of ingestion by humans, clients should be advised to contact a
physician immediately. Physicians may contact a Poison Control Center for advice concerning cases of
ingestion by humans.

ADVERSE REACTIONS

In reported clinical field trials with KIWOF HART, vomiting or diarrhea within 24 hours of dosing was
rarely observed (1.1% of administered doses). The following adverse reactions have been reported
following the use of KIWOF HART: Depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia,
staggering, convulsions and hypersalivation.

SAFETY

Reported studies with ivermectin indicate that certain dogs of the Collie breed are more sensitive to the
effects of ivermectin administered at elevated dose levels (more than 16 times the target use level) than
dogs of other breeds. At elevated doses, sensitive dogs showed adverse reactions which included
mydriasis, depression, ataxia, tremors, drooling, paresis, recumbency, excitability, stupor, coma and
death. KIWOF HART demonstrated no signs of toxicity at 10 times the recommended dose (60 mcg/kg) in
sensitive Collies.

Results of these trials and reported bioequivalency studies support the safety of KIWOF HART products
in dogs, including Collies, when used as recommended.
KIWOF HART has shown a wide margin of safety at the recommended dose level in dogs, including
pregnant or breeding bitches, stud dogs and puppies aged 6 or more weeks. In clinical trials, many
commonly used flea collars, dips, shampoos, anthelmintics, antibiotics, vaccines and steroid preparations
have been administered with KIWOF HART in a heartworm disease preventing program.

In one trial, where some pups had parvovirus, there was a marginal reduction in efficacy against
intestinal nematodes, possibly due to a change in intestinal transit time.

How Supplied: KIWOF HART is available in three dosage strengths (See DOSAGE section) for dogs of
different weights. Each strength comes in convenient cartons of 6 Chewable Tablets.

PRESENTATION: Blister of 6 Chewable Tablets

Storage: Store at controlled room temperature (15-30°C).

Protect from light.

Keep out of the reach of children

Details

COMPOSITION:

STRONGHEART PLUS [FOR SMALL SIZE DOGS]

Each Chewable Tablet Contains:


Ivermectin BP 68 mcg

Pyrantel Pamoate USP equivalent to Pyrantel 57 mg

Excipients q.s.

STRONGHEART PLUS [FOR MEDIUM SIZE DOGS]

Each Chewable Tablet Contains:

Ivermectin BP 136 mcg

Pyrantel Pamoate USP equivalent to Pyrantel 114 mg

Excipients q.s.

STRONGHEART PLUS [FOR LARGE SIZE DOGS]

Each Chewable Tablet Contains:

Ivermectin BP 272 mcg

Pyrantel Pamoate USP equivalent to Pyrantel 227 mg


Excipients q.s.

INDICATIONS:

For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae
(Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of ascarids
(Toxocara canis, Toxascaris leonina) and hookworms (Ancylostoma caninum, Undnaria stenocephala,
Ancylostoma braziliense).

DOSAGE:

Strongheart Plus should be administered orally at monthly intervals at the recommended minimum dose
level of 6 mcg of Ivermectin per kilogram (2.72 mcg/lb) and 5 mg of Pyrantel (as pamoate salt) per kg
(2.27 mg/lb) of body weight. The recommended dosing schedule for prevention of canine heartworm
disease and for the treatment and control of ascarids and hookworms is as follows:

Dog Weight

Tablet

Ivermectin

Pyrantel
Per Month

Content

Content

kg

lbs

Upto11kg

Upto 25 lbs

68 mcg
57 mg

12-22kg

26-50 lbs

136 mcg

114 mg

23-45kg

51-100 lbs

272 mcg

227 mg

Strongheart Plus is recommended for dogs 6 weeks of age and older.


For dogs over 100 lbs use the appropriate combination of these Chewable Tablets.

ADMINISTRATION:

Remove only one Chewable Tablet at a time from the foil-backed blister card. Return the card with the
remaining chewable tablets to its box to protect the product from light. Because most dogs find
Strongheart Plus palatable, the product can be offered to the dog by hand. Alternatively, it may be added
intact to a small amount of dog food. The chewable tablet should be administered in a manner that
encourages the dog to chew, rather than to swallow without chewing. Chewable Tablets may be broken
into pieces and fed to dogs that normally swallow treats whole.

Care should be taken that the dog consumes the complete dose, and treated animals should be
observed for a few minutes after administration to ensure that part of the dose is not lost or rejected. If
it is suspected that any of the dose has been lost, redosing is recommended.

Strongheart Plus should be given at monthly intervals during the period of the year when mosquitoes
(vectors), potentially carrying infective heartworm larvae, are active. The initial dose must be given
within a month (30 days) after the dog’s first exposure to mosquitoes. The final dose must be given
within a month (30 days) afterthe dog's last exposure to mosquitoes.

When replacing another heartworm preventive product in a heartworm disease preventive program, the
first dose of Strongheart Plus must be given within a month (30 days) of the last dose of the former
medication.

If the interval between doses exceeds a month (30 days), the efficacy of ivermectin can be reduced.
Therefore, for optimal performance, the Chewable Tablet must be given once a month on or about the
same day of the month. If treatment is delayed, whether by a few days or many, immediate treatment
with Strongheart Plus and resumption of the recommended dosing regimen minimizes the opportunity
forthe development of adult heartworms.

Monthly treatment with Strongheart Plus also provides effective treatment and control of ascarids (T.
canis, T. leonina) and hookworms (A. caninum, U. stenocephala, A. braziliense). Clients should be advised
of measures to be taken to prevent reinfection with intestinal parasites.
EFFICACY:

Strongheart Plus Chewable Tablet, given orally using the recommended dose and regimen, are effective
against the tissue larval stage of D. immitisfora month (30 days) after infection and, as a result, prevent
the development of the adult stage. Strongheart Plus chewable tablets are also effective against canine
ascarids (T. canis, T. leonina) and hookworms (A. caninum, U. stenocephala, A. braziliense).

ACCEPTABILITY:

In acceptability and field trials, Strongheart Plus was shown to be an acceptable oral dosage form that
was consumed at first offering by the majority of dogs.

PRECAUTIONS:

All dogs should be tested for existing heartworm infection before starting treatment with Strongheart
Plus which is not effective against adult D. immitis. Infected dogs must be treated to remove adult
heartworms and microfilariae before initiating a program with Strongheart Plus.

While some microfilariae may be killed by the ivermectin in Strongheart Plus at the recommended dose
level, Strongheart Plus is not effective for microfilariae clearance. A mild hypersensitivity-type reaction,
presumably due to dead or dying microfilariae and particularly involving a transient diarrhea, has been
observed in clinical trials with ivermectin alone after treatment of some dogs that have circulating
microfilariae.

WARNINGS:

In case of ingestion by humans, clients should be advised to contact a physician immediately. Physicians
may contact a Poison Control Center for advice concerning cases of ingestion by humans.
ADVERSE REACTIONS:

The following adverse reactions have been reported following the use of Strongheart Plus:
Depression/lethargy, vomiting, anorexia, diarrhea, mydriasis, ataxia, staggering, convulsions and
hypersalivation.

PRESENTATION:

Strongheart Plus is available in three dosage strengths (See DOSAGE section) for dogs of different
weights. Each strength comes in convenient cartons of 6 Chewable Tablet.

STORAGE:

Store at controlled room temperature (15-30°C). Protect from light.

Keep out of reach of children.

KIWOF

Praziquantel and Pyrantel Pamoate Chewable Tablets

COMPOSITION:

Each chewable tablet contains:

Praziquantel IP 20 mg
Pyrantel Pamoate IP 230 mg

Excipients q.s

INDICATIONS:

Kiwof is indicated for the treatment of Roundworms, Hookworms and Tapeworms in cats.

Worms controlled include:

Roundworms:

Toxocara cati,

Toxascaris leonina

Hookworms:

Ancylostoma tubaeforme,

Ancylostoma brazilense,
Uncinaria stenocephala

Tapeworms:

Dipylidium caninum

Taenia taeniaeformis

DOSAGE AND ADMINISTRATION:

The recommended dose rates are 57.5 mg/kg Pyrantel Pamoate and 5 mg/kg Praziquantel. This is
equivalent to 1 tablet per 4 kg (9 lbs) bodyweight. The tablet should be given directly but if necessary
can be disguised in food. Kiwof Tablets may be given directly by mouth or offered in a small amount of
food. Do not withhold food from the cat prior to or after treatment. The tablets are scored into halves to
enable a range of weights to be treated.

Dosage:

2 kg bodyweight – ½ tablet

2.1 to 4 kg bodyweight – 1 tablet

4 to 6 kg bodyweight – 1 ½ tablet

*Not intended for use in kittens less than 6 weeks of age.


Recommended treatments

Kittens: Treat at 6,8,10 and 12 weeks and then a monthly until 6 months of age, after that every 3
months or on veterinary advice.

Lactating queens: Should be treated concurrently with kittens.

Adults: Treat every 3 months or on veterinary advice.

CONTRAINDICATIONS, WARNINGS, ETC:

Do not use in pregnancy.

Not intended for use in kittens less than 6 weeks of age.

Do not use simultaneously with piperazine compounds.

In the interests of good hygiene, persons administering the tablets directly to the cat, or by adding them
to the cat’s food, should wash their hands afterwards.

For animal treatment only.

KEEP OUT OF REACH OF CHILDREN


Do not remove tablets from strip packing until required for use. Any part used tablets should be
discarded.

Safety:

Cats treated with 10 times the highest recommended dose have reported signs of vomiting and
salivation without other adverse effects. A temporary loss in appetite and loose stools have been
reported in some cats.

Disposal:

Disposal of any empty packaging and remaining product in the household refuse.

Further information:

In order to reduce the risk of reinfestation with the tapeworm Dipylidium caninum, appropriate control
measures for the flea intermediate host should be undertaken. The product has been shown to be
efficacious in the control of the tapeworm Joyeauxiella pasqualei, and is effective against Echinococcus
multilocularis.

PRESENTATION: Strip blister of 4 tablets

For the use only of a Veterinary Medical Practitioner only, Hospital or Laboratory or a Farm
FIPROFORT SPRAY

Fipronil Spray 0.25% w/v

COMPOSITION:

Each ml contains:

Fipronil 0.25% w/v

Excipients q.s.

PHARMACOLOGY

Mechanism of action:

Fipronil is a new generation broad-spectrum ectoparasiticidal belonging to phenylpyrazole class. Fipronil


disrupts the insect's central nervous system by blocking the passage of chloride ions through the GABA
receptor and glutamate receptor (GluCl).

Fipronil acts by binding to an allosteric site of GABA receptors. Its neurotoxicity is selective, because the
configuration of GABA receptors in mammals is different from insects.
INDICATIONS:

For effective treatment and prevention of all life stages of ectoparasites i.e. tick (including ticks
responsible for tick fever), flea (flea allergy dermatitis) and lice in Dogs and Cats.

DOSAGE AND ADMINISTRATION:

For 100 ml and 250 ml,

• Hold the bottle in upright position. Ruffle the animal’s coat while applying spray mist to its body.

• Put a pair of disposable gloves.

• Spray on the body of animal from a distance of 10-20 cm against the direction of hair in a well-
ventilated room (if you are treating a dog, you may prefer to treat it outside).

• Apply on entire body concentrating on affected area. Coat the spray all over to make sure the spray
gets right down to the skin.

• Allow animal to air dry. Do not towel dry.

APPLICATION:

In order to wet the coat down to the skin it is recommended that the following application rates be used:
Short-haired animals (<1.5 cm)

- A minimum of 3 ml/kg body mass = 7.5 mg of active material kg/body mass.

Long-haired animals (>1.5 cm)

- A minimum of 6 ml/kg body mass = 15 mg of active material kg/body mass.

250 ml bottle

Each trigger application delivers 1 ml spray volume

e.g. for large dogs over 12 kg

3 pump actions per kg

Weight 15 kg = 45 pumps actions


Weight 30 kg = 90 pumps actions

RESIDUAL ACTION: Ticks: 1 month (3-5 week), Fleas: 2 months (1-3 months) this will depend on the
parasite challenge in the animal's environment.

PRECAUTIONS:

• Avoid spraying into eyes while spraying on face. To prevent spraying into eyes and to ensure proper
coverage on head in nervous animals, puppies and kittens spray Fiprofort onto your gloves and rub on
face and other body parts.

• Do not allow animal to lick the spray.

• Do not shampoo for at least 2 days before and after Fiprofort treatment.

• Do not smoke, eat or drink during application.

• Wear gloves during spraying.

• Wash the hands after use.

• Spray in well-ventilated area.

• Keep sprayed animals away from source of heat until animal gets dry.
• Do not spray directly on the area of damaged skin.

Safety:

Fiprofort spray is safe to use in dogs and cats with no toxic effects when used in recommended way.
Fiprofort spray is not absorbed by skin and stay on for longer duration to provide effective protection.
Fiprofort spray is safe to use on cats and dogs 8 weeks of age and older, pregnant and lactating bitches.
Puppies and kittens may be treated from 2 days of age.

Toxicity:

In case of accidental ingestion or excessive licking by your pet contact your veterinarian immediately for
symptomatic treatment. Wash with plenty of fresh water immediately in case of contact with eyes or
open wound.

Only for use by or under the control of a veterinarian.

STORAGE: Store below 30oC in dark place. Protect from heat.

Keep out of reach of children.


CONTAINER DISPOSAL: Empty package or unused product can be disposed at waste disposal facility. Do
not reuse this container.

PHYSICAL OR CHEMICAL HAZARDS: FLAMMABLE

Keep away from heat and open flame.

PRESENTATION: Bottle of 250 ml

Details

FIPROFORT PLUS SPOT-ON SOLUTION FOR DOGS

Kills fleas, flea eggs & ticks

FIPROFORT PLUS for Dogs

Each pipette contains:

Fipronil 9.8% w/w

(S)-methoprene 8.8% w/w

Excipients q.s.
CATEGORY: Insecticide-acaricide

PHARMACODYNAMICS:

Fipronil is belonging to the family phenylpyrazole. It acts by interaction with complexes formed between
the chloride channels and their ligands, especially the neurotransmitter GABA (gamma-amino butyric
acid), thus blocking the transfer of chloride ions across cell membranes to levels pre and post synaptic. It
thus causes uncontrolled activity on the central nervous system of insects and mites and causes their
death. Fipronil kills fleas within 24 hours, ticks (Dermacentor variabilis, Rhipicephalus sanguineus, Ixodes
scapularis, Ixodes ricinus, Haemaphysalis longicornis, Haemaphysalis flava and Haemaphysalis

campanulata) and lice within 48 hours after application of the product.

The (S)-methoprene is a regulator of insect growth (ROI) of the class of similar juvenile hormone, it
inhibits the development of immature stages of insects. Mimicking the action of the juvenile hormone,
the compound causes impaired development and death of immature stages of fleas. The ovicidal activity
of (S)-methoprene applied to the dog results either from direct penetration into the shell flea eggs newly
laid or its absorption through the cuticle of adult fleas. The (S)-methoprene is also effective in preventing
the development of larvae and pupae chip, prevents contamination of the habitat of dogs treated with
the immature stages of fleas.

PHARMACOKINETICS:
Reported studies showed that absolute bioavailability of fipronil was 9.5 %. The mean maximum
concentration (Cmax) was found to be 19 ng/ml in plasma found after 5 days (Tmax). Plasma
concentrations were below 1 ng/ml (limit of quantification) by max approximately 33 days following
topical administration.

(S)-methoprene showed very low dermal absorption and all plasma concentrations were below the limit
of quantification (10 ng/ml).

In Dogs, fipronil’s major metabolite on the haircoat of the dog and in the blood stream is the sulfone
derivative. Fipronil sulfone is produced on the haircoat (mean concentrations < 16 % of fipronil during
the first month after treatment).

(S)-methoprene is extensively degraded into carbon dioxide and acetate that are subsequently
incorporated into endogenous materials.

In dogs after administration of the association topically, fipronil is poorly absorbed (11%) with average
maximum plasma concentration of approximately 35 ng/ml for fipronil and 55 ng/ml for fipronil sulfone.
In dogs, the plasma fipronil concentrations slowly reached a peak average about 101 hours and
decreasing slowly (half-life) by approximately 154 hours, the highest values are observed in males.

Plasma concentrations of (S)-methoprene are generally below the quantification (20 ng/ml) in dogs after
topical administration.

The concentrations of fipronil, fipronil sulfone and (S)-methoprene in peeling decreases with time, but
are detectable at least 60 days after application in dogs.

Parasites are killed mainly by contact and not by systemic exposure. No pharmacological interference
between fipronil and

(S)-methoprene was detected.

INDICATION AND DOSAGE:

FIPROFORT PLUS provides fast, effective and convenient treatment and control of fleas, ticks and
chewing lice.
Treatment and prevention of flea infestation (CtenocephaIides spp) and control of brown dog ticks
(Rhipicephalus sanguineus), paralysis tick (Ixodes holocyclus) and biting lice (Trichodectes canis) on dogs.

FIPROFORT PLUS has a rapid onset of action and kills re-infections with newly acquired adult fleas for at
least one month.

FIPROFORT PLUS also prevents the development of flea eggs, larvae and pupae produced by adult fleas
acquired for three months in dogs after treatment.

FIPROFORT PLUS controls brown dog ticks for up to one month and paralysis ticks for up to two weeks
after application in dogs. Daily searching of dog is necessary to minimize the risk of tick paralysis.
Searching should continue throughout the paralysis tick season.

FIPROFORT PLUS may be used for the treatment and control of Flea Allergy Dermatitis in dogs.
FIPROFORT PLUS is used for flea control as it breaks the life cycle on the dog and in its surrounding by
killing all stages of fleas.

Recommended Dosage for Dogs

Weight

Dose

FIPROFORT PLUS for small dogs

For use on puppies from 8 weeks of age)

upto 10 kg

0.67 ml/ pipette

FIPROFORT PLUS for medium dogs

10 - 20 kg

1.34 ml/ pipette


FIPROFORT PLUS for large dogs

20 - 40 kg

2.68 ml/ pipette

FIPROFORT PLUS for extra-large dogs

Over 40

4.02 ml/ pipette

TREATMENT FREQUENCY

For Fleas: Monthly application is recommended for dogs. All dogs in a household should be treated at
the same time. It is especially important to treat all household dogs if any pet is allergic to fleas (flea
allergy dermatitis).

Paralysis Ticks: Two-weekly application in dogs is recommended. FIPROFORT PLUS provides control of
paralysis ticks for up to 2 weeks, use of this product does not guarantee prevention of tick paralysis
because ticks are not killed immediately after attachment. Daily searching of dogs is necessary to
minimize the risk of tick paralysis. Searching should continue throughout the paralysis tick season, which
extends from Spring to Autumn, but may be year round in some localized areas.
Brown Dog Tick: Monthly application is recommended in dogs.

Biting Lice: Treat all household dogs at the same time.

APPLICATION:

Break the snap-off top from the pipette along the scored line. Part the hair at back of dog, at the base of
the neck between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and
squeeze gently at one or two spots to empty its contents onto the skin. Care should be taken to avoid
excessive wetting of hair during treatment of dogs. Do not allow treated dogs to lick each other or rub
against other animals until the application site is dry[RD1]

CAUTION: Hazardous to Human.

This product may cause irritation of mucous membranes, skin and eyes. So avoid contact of the product
with the mouth, skin or eyes. Dogs or those who have known hypersensitivity to insecticides or alcohol
should avoid contact with the drug. Avoid contact of contents with the fingers. If this occurs, wash hands
with soap and water. In case of accidental exposure with eyes, rinse with clean water carefully. Do not
handle treated dogs and don’t allow children to play with treated dogs until the application site is dry. It
is therefore recommended that dogs are not treated in the day but in the early evening and that recently
treated dogs are not allowed to sleep with owners, especially children. Do not smoke, drink or eat during
application.
Do not apply FIPROFORT PLUS for more than 30 days.

SAFETY IN DOGS: For external use only.

FIPROFORT PLUS is safe for use in dogs and puppies over 8 weeks of age and in breeding, pregnant or
lactating bitches. Do not use FIPROFORT PLUS if you or your pet has a known hypersensitivity to
insecticides or alcohol.

STORAGE: Store below 30°C in dark place. Protect from heat.

PHYSICAL OR CHEMICAL HAZARDS: FLAMMABLE

Keep away from heat and open flame.


CONTAINER DISPOSAL: Fipronil and (S)-methoprene may adversely affect aquatic organisms. Do not
discard the product or empty pipettes in ponds, rivers and streams. Securely wrap pipette in several
layers of newspaper and discard in trash.

Veterinary. Not for human use. For animal treatment only. For external application only.

FOR THE TREATMENT OF DOGS ONLY.

PRESENTATION:

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs upto 10kg Pipette of 0.67 ml

(FOR USE ON PUPPIES FROM 8 WEEKS OF AGE)

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 10kg upto 20kg Pipette of 1.34 ml

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 20kg upto 40kg Pipette of 2.68 ml

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 40kg Pipette of 4.02 ml
FIPROFORT PLUS SPOT-ON SOLUTION FOR DOGS

Kills fleas, flea eggs & ticks

FIPROFORT PLUS for Dogs

Each pipette contains:

Fipronil 9.8% w/w

(S)-methoprene 8.8% w/w

Excipients q.s.

CATEGORY: Insecticide-acaricide

PHARMACODYNAMICS:

Fipronil is belonging to the family phenylpyrazole. It acts by interaction with complexes formed between
the chloride channels and their ligands, especially the neurotransmitter GABA (gamma-amino butyric
acid), thus blocking the transfer of chloride ions across cell membranes to levels pre and post synaptic. It
thus causes uncontrolled activity on the central nervous system of insects and mites and causes their
death. Fipronil kills fleas within 24 hours, ticks (Dermacentor variabilis, Rhipicephalus sanguineus, Ixodes
scapularis, Ixodes ricinus, Haemaphysalis longicornis, Haemaphysalis flava and
Haemaphysaliscampanulata) and lice within 48 hours after application of the product.
The (S)-methoprene is a regulator of insect growth (ROI) of the class of similar juvenile hormone, it
inhibits the development of immature stages of insects. Mimicking the action of the juvenile hormone,
the compound causes impaired development and death of immature stages of fleas. The ovicidal activity
of (S)-methoprene applied to the dog results either from direct penetration into the shell flea eggs newly
laid or its absorption through the cuticle of adult fleas. The (S)-methoprene is also effective in preventing
the development of larvae and pupae chip, prevents contamination of the habitat of dogs treated with

the immature stages of fleas.

PHARMACOKINETICS:

Reported studies showed that absolute bioavailability of fipronil was 9.5 %. The mean maximum
concentration (Cmax) was found to be 19 ng/ml in plasma found after 5 days (Tmax). Plasma
concentrations were below 1 ng/ml (limit of quantification) by max approximately 33 days following
topical administration.

(S)-methoprene showed very low dermal absorption and all plasma concentrations were below the limit
of quantification (10 ng/ml).

In Dogs, fipronil’s major metabolite on the haircoat of the dog and in the blood stream is the sulfone
derivative. Fipronil sulfone is produced on the haircoat (mean concentrations < 16 % of fipronil during
the first month after treatment).
(S)-methoprene is extensively degraded into carbon dioxide and acetate that are subsequently
incorporated into endogenous materials.

In dogs after administration of the association topically, fipronil is poorly absorbed (11%) with average
maximum plasma concentration of approximately 35 ng/ml for fipronil and 55 ng/ml for fipronil sulfone.

In dogs, the plasma fipronil concentrations slowly reached a peak average about 101 hours and
decreasing slowly (half-life) by approximately 154 hours, the highest values are observed in males.

Plasma concentrations of (S)-methoprene are generally below the quantification (20 ng/ml) in dogs after
topical administration.

The concentrations of fipronil, fipronil sulfone and (S)-methoprene in peeling decreases with time, but
are detectable at least 60 days after application in dogs.

Parasites are killed mainly by contact and not by systemic exposure. No pharmacological interference
between fipronil and
(S)-methoprene was detected.

INDICATION AND DOSAGE:

FIPROFORT PLUS provides fast, effective and convenient treatment and control of fleas, ticks and
chewing lice.

Treatment and prevention of flea infestation (CtenocephaIides spp) and control of brown dog ticks
(Rhipicephalus sanguineus), paralysis tick (Ixodes holocyclus) and biting lice (Trichodectes canis) on dogs.

FIPROFORT PLUS has a rapid onset of action and kills re-infections with newly acquired adult fleas for at
least one month.

FIPROFORT PLUS also prevents the development of flea eggs, larvae and pupae produced by adult fleas
acquired for three months in dogs after treatment.

FIPROFORT PLUS controls brown dog ticks for up to one month and paralysis ticks for up to two weeks
after application in dogs. Daily searching of dog is necessary to minimize the risk of tick paralysis.
Searching should continue throughout the paralysis tick season.
FIPROFORT PLUS may be used for the treatment and control of Flea Allergy Dermatitis in dogs.

FIPROFORT PLUS is used for flea control as it breaks the life cycle on the dog and in its surrounding by
killing all stages of fleas.

Recommended Dosage for Dogs

Weight

Dose

FIPROFORT PLUS for small dogs


For use on puppies from 8 weeks of age)

upto 10 kg

0.67 ml/ pipette

FIPROFORT PLUS for medium dogs

10 - 20 kg

1.34 ml/ pipette

FIPROFORT PLUS for large dogs

20 - 40 kg

2.68 ml/ pipette

FIPROFORT PLUS for extra-large dogs

Over 40
4.02 ml/ pipette

TREATMENT FREQUENCY

For Fleas: Monthly application is recommended for dogs. All dogs in a household should be treated at
the same time. It is especially important to treat all household dogs if any pet is allergic to fleas (flea
allergy dermatitis).

Paralysis Ticks: Two-weekly application in dogs is recommended. FIPROFORT PLUS provides control of
paralysis ticks for up to 2 weeks, use of this product does not guarantee prevention of tick paralysis
because ticks are not killed immediately after attachment. Daily searching of dogs is necessary to
minimize the risk of tick paralysis. Searching should continue throughout the paralysis tick season, which
extends from Spring to Autumn, but may be year round in some localized areas.

Brown Dog Tick: Monthly application is recommended in dogs.

Biting Lice: Treat all household dogs at the same time.


APPLICATION:

Break the snap-off top from the pipette along the scored line. Part the hair at back of dog, at the base of
the neck between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and
squeeze gently at one or two spots to empty its contents onto the skin. Care should be taken to avoid
excessive wetting of hair during treatment of dogs. Do not allow treated dogs to lick each other or rub
against other animals until the application site is dry[RD1] .

CAUTION: Hazardous to Human.

This product may cause irritation of mucous membranes, skin and eyes. So avoid contact of the product
with the mouth, skin or eyes. Dogs or those who have known hypersensitivity to insecticides or alcohol
should avoid contact with the drug. Avoid contact of contents with the fingers. If this occurs, wash hands
with soap and water. In case of accidental exposure with eyes, rinse with clean water carefully. Do not
handle treated dogs and don’t allow children to play with treated dogs until the application site is dry. It
is therefore recommended that dogs are not treated in the day but in the early evening and that recently
treated dogs are not allowed to sleep with owners, especially children. Do not smoke, drink or eat during
application.

Do not apply FIPROFORT PLUS for more than 30 days.

SAFETY IN DOGS: For external use only.


FIPROFORT PLUS is safe for use in dogs and puppies over 8 weeks of age and in breeding, pregnant or
lactating bitches. Do not use FIPROFORT PLUS if you or your pet has a known hypersensitivity to
insecticides or alcohol.

STORAGE: Store below 30°C in dark place. Protect from heat.

PHYSICAL OR CHEMICAL HAZARDS: FLAMMABLE

Keep away from heat and open flame.

CONTAINER DISPOSAL: Fipronil and (S)-methoprene may adversely affect aquatic organisms. Do not
discard the product or empty pipettes in ponds, rivers and streams. Securely wrap pipette in several
layers of newspaper and discard in trash.

Veterinary. Not for human use. For animal treatment only. For external application only.
FOR THE TREATMENT OF DOGS ONLY.

PRESENTATION:

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs upto 10kg Pipette of 0.67 ml

(FOR USE ON PUPPIES FROM 8 WEEKS OF AGE)

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 10kg upto 20kg Pipette of 1.34 ml

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 20kg upto 40kg Pipette of 2.68 ml

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 40kg Pipette of 4.02 ml

FIPROFORT PLUS SPOT-ON SOLUTION FOR DOGS

Kills fleas, flea eggs & ticks

FIPROFORT PLUS for Dogs

Each pipette contains:

Fipronil 9.8% w/w


(S)-methoprene 8.8% w/w

Excipients q.s.

CATEGORY: Insecticide-acaricide

PHARMACODYNAMICS:

Fipronil is belonging to the family phenylpyrazole. It acts by interaction with complexes formed between
the chloride channels and their ligands, especially the neurotransmitter GABA (gamma-amino butyric
acid), thus blocking the transfer of chloride ions across cell membranes to levels pre and post synaptic. It
thus causes uncontrolled activity on the central nervous system of insects and mites and causes their
death. Fipronil kills fleas within 24 hours, ticks (Dermacentor variabilis, Rhipicephalus sanguineus, Ixodes
scapularis, Ixodes ricinus, Haemaphysalis longicornis, Haemaphysalis flava and Haemaphysalis

campanulata) and lice within 48 hours after application of the product.

The (S)-methoprene is a regulator of insect growth (ROI) of the class of similar juvenile hormone, it
inhibits the development of immature stages of insects. Mimicking the action of the juvenile hormone,
the compound causes impaired development and death of immature stages of fleas. The ovicidal activity
of (S)-methoprene applied to the dog results either from direct penetration into the shell flea eggs newly
laid or its absorption through the cuticle of adult fleas. The (S)-methoprene is also effective in preventing
the development of larvae and pupae chip, prevents contamination of the habitat of dogs treated with
the immature stages of fleas.
PHARMACOKINETICS:

Reported studies showed that absolute bioavailability of fipronil was 9.5 %. The mean maximum
concentration (Cmax) was found to be 19 ng/ml in plasma found after 5 days (Tmax). Plasma
concentrations were below 1 ng/ml (limit of quantification) by max approximately 33 days following
topical administration.

(S)-methoprene showed very low dermal absorption and all plasma concentrations were below the limit
of quantification (10 ng/ml).

In Dogs, fipronil’s major metabolite on the haircoat of the dog and in the blood stream is the sulfone
derivative. Fipronil sulfone is produced on the haircoat (mean concentrations < 16 % of fipronil during
the first month after treatment).

(S)-methoprene is extensively degraded into carbon dioxide and acetate that are subsequently
incorporated into endogenous materials.

In dogs after administration of the association topically, fipronil is poorly absorbed (11%) with average
maximum plasma concentration of approximately 35 ng/ml for fipronil and 55 ng/ml for fipronil sulfone.
In dogs, the plasma fipronil concentrations slowly reached a peak average about 101 hours and
decreasing slowly (half-life) by approximately 154 hours, the highest values are observed in males.

Plasma concentrations of (S)-methoprene are generally below the quantification (20 ng/ml) in dogs after
topical administration.

The concentrations of fipronil, fipronil sulfone and (S)-methoprene in peeling decreases with time, but
are detectable at least 60 days after application in dogs.

Parasites are killed mainly by contact and not by systemic exposure. No pharmacological interference
between fipronil and

(S)-methoprene was detected.

INDICATION AND DOSAGE:

FIPROFORT PLUS provides fast, effective and convenient treatment and control of fleas, ticks and
chewing lice.
Treatment and prevention of flea infestation (CtenocephaIides spp) and control of brown dog ticks
(Rhipicephalus sanguineus), paralysis tick (Ixodes holocyclus) and biting lice (Trichodectes canis) on dogs.

FIPROFORT PLUS has a rapid onset of action and kills re-infections with newly acquired adult fleas for at
least one month.

FIPROFORT PLUS also prevents the development of flea eggs, larvae and pupae produced by adult fleas
acquired for three months in dogs after treatment.

FIPROFORT PLUS controls brown dog ticks for up to one month and paralysis ticks for up to two weeks
after application in dogs. Daily searching of dog is necessary to minimize the risk of tick paralysis.
Searching should continue throughout the paralysis tick season.

FIPROFORT PLUS may be used for the treatment and control of Flea Allergy Dermatitis in dogs.
FIPROFORT PLUS is used for flea control as it breaks the life cycle on the dog and in its surrounding by
killing all stages of fleas.

Recommended Dosage for Dogs

Weight

Dose

FIPROFORT PLUS for small dogs

For use on puppies from 8 weeks of age)

upto 10 kg
0.67 ml/ pipette

FIPROFORT PLUS for medium dogs

10 - 20 kg

1.34 ml/ pipette

FIPROFORT PLUS for large dogs

20 - 40 kg

2.68 ml/ pipette

FIPROFORT PLUS for extra-large dogs

Over 40

4.02 ml/ pipette

TREATMENT FREQUENCY
For Fleas: Monthly application is recommended for dogs. All dogs in a household should be treated at
the same time. It is especially important to treat all household dogs if any pet is allergic to fleas (flea
allergy dermatitis).

Paralysis Ticks: Two-weekly application in dogs is recommended. FIPROFORT PLUS provides control of
paralysis ticks for up to 2 weeks, use of this product does not guarantee prevention of tick paralysis
because ticks are not killed immediately after attachment. Daily searching of dogs is necessary to
minimize the risk of tick paralysis. Searching should continue throughout the paralysis tick season, which
extends from Spring to Autumn, but may be year round in some localized areas.

Brown Dog Tick: Monthly application is recommended in dogs.

Biting Lice: Treat all household dogs at the same time.

APPLICATION:

Break the snap-off top from the pipette along the scored line. Part the hair at back of dog, at the base of
the neck between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and
squeeze gently at one or two spots to empty its contents onto the skin. Care should be taken to avoid
excessive wetting of hair during treatment of dogs. Do not allow treated dogs to lick each other or rub
against other animals until the application site is dry[RD1] .
CAUTION: Hazardous to Human.

This product may cause irritation of mucous membranes, skin and eyes. So avoid contact of the product
with the mouth, skin or eyes. Dogs or those who have known hypersensitivity to insecticides or alcohol
should avoid contact with the drug. Avoid contact of contents with the fingers. If this occurs, wash hands
with soap and water. In case of accidental exposure with eyes, rinse with clean water carefully. Do not
handle treated dogs and don’t allow children to play with treated dogs until the application site is dry. It
is therefore recommended that dogs are not treated in the day but in the early evening and that recently
treated dogs are not allowed to sleep with owners, especially children. Do not smoke, drink or eat during
application.

Do not apply FIPROFORT PLUS for more than 30 days.

SAFETY IN DOGS: For external use only.

FIPROFORT PLUS is safe for use in dogs and puppies over 8 weeks of age and in breeding, pregnant or
lactating bitches. Do not use FIPROFORT PLUS if you or your pet has a known hypersensitivity to
insecticides or alcohol.
STORAGE: Store below 30°C in dark place. Protect from heat.

PHYSICAL OR CHEMICAL HAZARDS: FLAMMABLE

Keep away from heat and open flame.

CONTAINER DISPOSAL: Fipronil and (S)-methoprene may adversely affect aquatic organisms. Do not
discard the product or empty pipettes in ponds, rivers and streams. Securely wrap pipette in several
layers of newspaper and discard in trash.

Veterinary. Not for human use. For animal treatment only. For external application only.

FOR THE TREATMENT OF DOGS ONLY.


PRESENTATION:

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs upto 10kg Pipette of 0.67 ml

(FOR USE ON PUPPIES FROM 8 WEEKS OF AGE)

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 10kg upto 20kg Pipette of 1.34 ml

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 20kg upto 40kg Pipette of 2.68 ml

FIPROFORT PLUS SPOT-ON SOLUTION For Dogs over 40kg Pipette of 4.02 ml

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