Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200

mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

Cisplatin Injection BP Water for Injection......... Q.S.

Excipients: ....................Q.S.
10mg/10ml, 10mg/20ml,
50mg/50ml, 100mg/100ml d) Cisplatin Injection BP 50mg/100ml Taj
and 200mg/200ml Taj Pharma
Eachml contains:
Pharma Cisplatin BP ...................0.5mg
Water for Injection......... Q.S.
1. NAME OF THE MEDICINAL Excipients: ....................Q.S.
PRODUCT
e)Cisplatin Injection BP 100mg/100ml Taj
Cisplatin Injection BP 10mg/10ml Taj Pharma
Pharma Eachml contains:
Cisplatin Injection BP 10mg/20ml Taj Cisplatin BP ...................1mg
Pharma Water for Injection......... Q.S.
Cisplatin Injection BP 50mg/50ml Taj Excipients: ....................Q.S.
Pharma
Cisplatin Injection BP 50mg/100ml Taj f) Cisplatin Injection BP 200mg/200ml Taj
Pharma Pharma
Cisplatin Injection BP 100mg/100ml Taj Eachml contains:
Pharma Cisplatin BP ...................1mg
Cisplatin Injection BP 200mg/200ml Taj Water for Injection......... Q.S.
Pharma Excipients: ....................Q.S.
2. QUALITATIVE AND For the full list of excipients, see section 6.1.
QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
a) Cisplatin Injection BP 10mg/10ml Taj
Pharma Cisplatin Taj Pharma solution for injection.
Eachml contains:
Cisplatin BP ...................1mg 4. CLINICAL PARTICULARS
Water for Injection......... Q.S.
Excipients: ....................Q.S. 4.1 Therapeutic indications
b) Cisplatin Injection BP 10mg/20ml Taj To be used as mono-therapy, or as part of an
Pharma existing chemotherapy for advanced or
Eachml contains: metastatic tumours: testicular carcinoma
Cisplatin BP ...................0.5mg (palliative and curative poly-chemotherapy)
Water for Injection......... Q.S. and ovary carcinoma (stages III and IV), and
Excipients: ....................Q.S. head and neck squamous-cell epithelioma
(palliative therapy).
c) Cisplatin Injection BP 50mg/50ml Taj
Pharma In the treatment of small cell lung
Eachml contains: carcinoma.
Cisplatin BP ...................1mg
 Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200 mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

In the treatment of advanced non-small cell For warnings and precautions to be

lung carcinoma. considered prior to the start of the next
treatment cycle, see section 4.4.
4.2 Posology and method of
administration In patients with renal dysfunction or bone
marrow depression, the dose should be
Posology reduced adequately.

Adults and children: Method of administration

The Cisplatin Taj Pharma dosage depends Cisplatin Taj Pharma "Ebewe" 10mg/20ml
on the primary disease, the expected Cisplatin Taj Pharma solution for injection
reaction, and on whether Cisplatin Taj is to be diluted before use (see section 6.6.).
Pharma is used for monotherapy or as a
component of a combination chemotherapy. The diluted solution should be administered
The dosage directions are applicable for only intravenously by injection (see below).
both adults and children. For For administration, any device containing
recommendations on the dosage applicable, aluminium that may come in contact with
based on the diagnosis and the clinical Cisplatin Taj Pharma (sets for intravenous
condition, the current medical literature injection, needles, catheters, syringes) must
should be consulted. be avoided (see section 6.2.).

For monotherapy, the following two dosage The Cisplatin Taj Pharma solution for
regimens are recommended: injection prepared according to instructions
(see section 6.6.) should be administered by
Single dose of 50 to 120mg/m2 body surface intravenous injection over a period of 6 to 8
every 3 to 4 weeks; 15 to 20mg/m2/day for hours.
five days, every 3 to 4 weeks.
Adequate hydration must be maintained
If Cisplatin Taj Pharma is used from 2 to 12 hours prior to administration
in combination chemotherapy, the dose of until minimum 6 hours after the
Cisplatin Taj Pharma must be reduced. A administration of Cisplatin Taj Pharma.
typical dose is 20mg/m2 or more once every Hydration is necessary to cause sufficient
3 to 4 weeks unless in the combination diuresis during and after treatment with
therapy of small-cell and non-small-cell Cisplatin Taj Pharma. It is realised by
lung carcinoma, in which a typical dose of intravenous injection of one of the following
80mg/m2 is administered. solutions: sodium chloride solution 0.9%;
mixture of sodium chloride solution 0.9%
Further dosage recommendations are to be and glucose solution 5% (1:1).
based upon current medical insights, to be
obtained from the literature or/and the Hydration prior to treatment with Cisplatin
appropriate working parties. Taj Pharma:

Intravenous injection of 100 to 200ml/hour

for a period of 6 to 12 hours.
 Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200 mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

Hydration after termination of the in combination with yellow fever vaccine

administration of Cisplatin Taj Pharma: and phenytoin in prophylactic use (See
section 4.5)
Intravenous injection of another 2 litres at a
rate of 100 to 200ml per hour for a period of 4.4 Special warnings and precautions for
6 to 12 hours. use

Forced diuresis may be required should the Cisplatin Taj Pharma reacts with metallic
urine secretion be less than 100 to aluminum to form a black precipitate of
200ml/hour after hydration. Forced diuresis platinum. All aluminum containing IV sets,
may be realised by intravenously needles, catheters and syringes should be
administering 37.5g mannitol as a 10% avoided.
solution (375ml mannitol solution 10%), or
by administration of a diuretic if the kidney Cisplatin Taj Pharma must be administered
functions are normal. The administration of under close supervision by a qualified doctor
mannitol or a diuretic is also required when specialized in the use of chemotherapeutic
the administrated Cisplatin Taj Pharma dose agents.
is higher than 60mg/m2 of body surface.
Appropriate monitoring and management of
It is necessary that the patient drinks large the treatment and its complications are only
quantities of liquids for 24 hours after the possible if adequate diagnosis and exact
Cisplatin Taj Pharma injection to ensure treatment conditions are available.
adequate urine secretion.
Nephrotoxicity
4.3 Contraindications
Cisplatin Taj Pharma causes severe
Hypersensitivity to the active substance or cumulative nephrotoxicity. A urine output of
other platinum containing compounds, or to 100ml/hour or greater will tend to minimize
any of the excipients listed in section 6.1. Cisplatin Taj Pharma nephrotoxicity. This
can be accomplished by pre-hydration with
in dehydrated condition (pre- and post- 2 liters of an appropriate intravenous
hydration is required to prevent serious renal solution, and similar post Cisplatin Taj
dysfunction); Pharma hydration (recommended
2,500ml/m2/24 hours). If vigorous hydration
with myelosuppression; is insufficient to maintain adequate urinary
output, an osmotic diuretic may be
pre-existing renal impairment or hearing administered (eg, mannitol).
impairment due to the fact that Cisplatin Taj
Pharma is nephrotoxic and neurotoxic (in Neuropathies
particular ototoxic). These toxicities may be
cumulative if disorders of this type pre- Severe cases of neuropathies have been
exist.who are pregnant or breastfeeding (see reported. These neuropathies may be
section 4.6.) irreversible and may manifest by
paraesthesia, areflexia and a proprioceptive
loss and a sensation of vibrations. A loss of
 Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200 mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

motor function has also been reported. A The hematological formula and the hepatic
neurologic examination must be carried out function must be monitored at regular
at regular intervals. intervals.

Ototoxicity Carcinogenic potential

Ototoxicity has been observed in up to 31% In humans, in rare cases the appearance of
of patients treated with a single dose of acute leukemia has coincided with use of
Cisplatin Taj Pharma 10mg/m2, and is Cisplatin Taj Pharma, which was in general
manifested by tinnitus and/or hearing loss in associated with other leukemogenic agents.
the high frequency range (4000 to 8000Hz).
Decreased ability to hear conversational Cisplatin Taj Pharma is a bacterial mutagen
tones may occur occasionally. Ototoxic and causes chromosome aberrations in
effect may be more pronounced in children cultures on animal cells. Carcinogenicity is
receiving Cisplatin Taj Pharma. Hearing loss possible but has not been demonstrated.
can be unilateral or bilateral and tends to Cisplatin Taj Pharma is teratogenic and
become more frequent and severe with embryotoxic in mice.
repeated doses; however, deafness after
initial dose of Cisplatin Taj Pharma has been Injection site reactions
reported rarely. Ototoxicity may be
enhanced with prior simultaneous cranial Injection site reactions may occur during the
irradiation and may be related to peak administration of Cisplatin Taj Pharma.
plasma concentration of Cisplatin Taj Given the possibility of extravasation, it is
Pharma. It is unclear whether Cisplatin Taj recommended to closely monitor the
Pharma induced ototoxicity is reversible. injection site for possible infiltration during
Careful monitoring by audiometry should be drug administration. A specific treatment for
performed prior to initiation of therapy and extravasation reactions is unknown at this
prior to subsequent doses of Cisplatin Taj time.
Pharma. Vestibular toxicity has also been
reported (see section 4.8 Undesirable Warning
effects).
This cytostatic agent has a more marked
Allergic phenomena toxicity than is usually found in
antineoplastic chemotherapy.
As with other platinum-based products,
hypersensitivity reactions appearing in most Renal toxicity, which is above-all
cases during perfusion may occur, and cumulative, is severe and requires particular
necessitate discontinuation of the perfusion precautions during administration (see
and an appropriate symptomatic treatment. section 4.2 Posology and method of
Cross reactions, sometimes fatal, have been administration and section 4.8 Undesirable
reported with all the platinum compounds effects).
(see section 4.3 Contraindications and
section 4.8 Undesirable effects). Nausea and vomiting may be intense and

Hepatic function and hematological formula

 Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200 mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

require adequate antiemetic treatment. of the WHO recommended maximum daily

intake of 2 g sodium for an adult.
Close supervision must also be carried out
with regard to ototoxicity, myelodepression This medicinal product contains 354mg
and anaphylactic reactions (see section 4.8 sodium per 100ml vial, equivalent to 17.7%
Undesirable effects). of the WHO recommended maximum daily
intake of 2 g sodium for an adult.
Warning
4.5 Interaction with other medicinal
Preparation of the intravenous solution products and other forms of interaction

As with all other potentially toxic products, Nephrotoxic substances

precautions are essential when handling the
Cisplatin Taj Pharma solution. Skin lesions Concomitant administration of nephrotoxic
are possible in the event of accidental (e.g. cephalosporins, aminoglycosides,
exposure to the product. It is advisable to amphotericin B or contrast media) or
wear gloves. In the event the Cisplatin Taj ototoxic (e.g. aminoglycosides) medicinal
Pharma solution comes into contact with the products will potentiate the toxic effect of
skin or mucous membranes, wash the skin or Cisplatin Taj Pharma on the kidneys. During
mucous membranes vigorously with soap or after treatment with Cisplatin Taj Pharma
and water. caution is advised with predominantly
renally eliminated substances, e.g. cytostatic
Conforming to the procedures appropriate agents such as bleomycin and methotrexate,
for the manipulation and elimination of because of potentially reduced renal
cytostatic agents is recommended. elimination.

Administering the solution to the patient, The renal toxicity of ifosfamide may be
verify the clarity of the solution and the greater when used with Cisplatin Taj
absence of particles. Pharma or in patients who have previously
been given Cisplatin Taj Pharma.

Reduction of the blood's lithium values was

This medicinal product contains 35mg noticed in a few cases after treatment with
sodium per 20ml vial, equivalent to 1.75% Cisplatin Taj Pharma combined with
of the WHO recommended maximum daily
bleomycin and etoposide. It is therefore
intake of 2 g sodium for an adult. recommended to monitor the lithium values.
This medicinal product contains 71mg
Ototoxic substances
sodium per 20ml vial, equivalent to 3.55%
of the WHO recommended maximum daily
Concomitant administration of ototoxic (e.g.
intake of 2 g sodium for an adult. aminoglycosides, loop diuretics) medicinal
products will potentiate the toxic effect of
This medicinal product contains 177mg Cisplatin Taj Pharma on auditory function.
sodium per 50ml vial, equivalent to 8.85%
Except for patients receiving doses of
Cisplatin Taj Pharma exceeding 60mg/m2,
 Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200 mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

whose urine secretion is less than 1000ml (hexamethylmelamine) and Cisplatin Taj
per 24 hours, no forced diuresis with loop Pharma.
diuretics should be applied in view of
possible damage to the kidney tract and Paclitaxel
ototoxicity.
Treatment with Cisplatin Taj Pharma prior
Ifosfamide may increase hearing loss due to to an injection with paclitaxel may reduce
Cisplatin Taj Pharma. the clearance of paclitaxel by 33% and
therefore can intensify neurotoxicity.
Attenuated live vaccines
4.6 Fertility, pregnancy and lactation
Yellow fever vaccine is strictly
contraindicated because of the risk of fatal Pregnancy
systemic vaccinal disease (see section 4.3
Contraindications). In view of the risk of There are no adequate data from the use of
generalized illness, it is advisable to use an Cisplatin Taj Pharma in pregnant women,
inactivated vaccine if available. but based on its pharmacological properties
Cisplatin Taj Pharma is suspected to cause
Oral anticoagulants serious birth defects. Studies in animals
have shown reproductive toxicity and
In the event of simultaneous use of oral transplacental carcinogenicity (see section
anticoagulants, it is advisable regularly to 5.3.). Cisplatin Taj Pharma is
check the INR. contraindicated during the pregnancy period.

Antihistamines, Phenothiazines and others Breast-feeding

Simultaneous use of antihistamines, Cisplatin Taj Pharma is excreted in human

buclizine, cyclizine, loxapine, meclozine, milk. Breastfeeding during the therapy is
phenothiazines, thioxanthenes or contraindicated.
trimethobenzamides may mask ototoxicity
symptoms (such as dizziness and tinnitus). Fertility

Anticonvulsive substances Both male and female patients must use

effective contraceptive methods to prevent
Serum concentrations of anticonvulsive conception and/or reproduction during and
medicines may remain at sub-therapeutic for at least 6 months after treatment with
levels during treatment with Cisplatin Taj Cisplatin Taj Pharma.
Pharma.
Genetic consultation is recommended if the
Pyridoxine + altretamine combination patient wishes to have children after ending
the treatment. Since a treatment with
During a randomized study of the treatment Cisplatin Taj Pharma may cause irreversible
of advanced ovarian cancer, the response infertility, it is recommended that men, who
time was unfavorably affected when wish to become fathers in the future, ask for
pyridoxine in combination with altretamine
 Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200 mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

advice regarding cryoconservation of their Table of Adverse Drug Events reported

sperm prior to the treatment. during clinical or post-marketing experience
(MedDRA terms)

Infections and infestations

4.7 Effects on ability to drive and use Common Sepsis
machines
Not known Infectiona
Due to the possible side effects Cisplatin Taj Neoplasm benign, malignant, and
Pharmahas minor or moderate influence on unspecified
the ability to drive and use machines. Uncommon Acute leukemia
Patients who suffer from these effects (eg Blood and lymphatic system disorders
feeling sleepy or vomiting) must avoid
Bone marrow failure,
driving and operating machinery. Very
thrombocytopenia, leukopenia,
common
anemia
4.8 Undesirable effects
Coombs positive hemolytic
Not known
Undesirable effects depend on the used dose anemia
and may have cumulative effects. Immune system disorders
Uncommon Anaphylactoidb reactions
The most frequently reported adverse events Endocrine disorders
(>10%) of Cisplatin Taj Pharma were
Blood amylase increased,
haematological (leukopenia,
Not known inappropriate antidiurectic
thrombocytopenia and anaemia),
hormone secretion
gastrointestinal (anorexia, nausea, vomiting
and diarrhoea), ear disorders (hearing Metabolism and nutrition disorders
impairment), renal disorders (renal failure, Very
Hyponatremia
nephrotoxicity, hyperuricaemia) and fever. common
Uncommon Hypomagnesemia
Serious toxic effects on the kidneys, bone Dehydration, hypokalemia,
marrow and ears have been reported in up to hypophosphatemia,
about one third of patients given a single Not known
hyperuricemia, hypocalcemia,
dose of Cisplatin Taj Pharma; the effects are tetany
generally dose-related and cumulative.
Ototoxicity may be more severe in children. Nervous system disorders
Convulsion, neuropathy
The list is presented by system organ class, peripheral,
MedDRA preferred term, and frequency leukoencephalopathy,
Rare
using the following frequency categories: reversible posterior
leukoencephalopathy
very common (≥ 1/10), common (≥ 1/100, < syndrome
1/10), uncommon (≥1/1000, < 1/100), rare Cerebrovascular accident,
(≥ 1/10000, < 1/1000), very rare (< hemorrhagic stroke, ischemic
Not known
1/10000), and not known (cannot be stroke, ageusia, cerebral
estimated from the available data). arteritis, Lhermitte's sign,
 Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200 mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

myelopathy, autonomic Reproductive system and breast

neuropathy disorders
Eye disorders Uncommon Abnormal spermatogenesis
Vision blurred, color blindness General disorders and administration
acquired, blindness cortical, site conditions
Not known
optic neuritis, papilledema, Very
retinal pigmentation Pyrexia
common
Ear and labyrinth disorders Asthenia, malaise, injection
Not known
Uncommon Ototoxicity site extravasationd
Not known Tinnitus, deafness
Cardiac disorders a: Infectious complications have led to death
Arrhythmia, bradycardia, in some patients.
Common:
tachycardia
b: Symptoms reported for anaphylactoid
Rare Myocardial infarction reaction such as facial edema (PT-face
Very rare Cardiac arrest oedema), wheezing, bronchospasm,
Not known Cardiac disorder tachycardia, and hypotension will be
Vascular disorders included in the parentheses for
anaphylactoid reaction in the AE frequency
Common Venous thromboembolism
table.
Thrombotic microangiopathy
Not known (hemolytic uremic syndrome), c: Elevations in BUN and creatinine, serum
Raynaud's phenomenon uric acid, and/or a decrease in creatinine
Respiratory, thoracic and mediastinal clearance are subsumed under renal
disorders insufficiency/failure.
Not known Pulmonary embolism
Gastrointestinal disorders d: Local soft tissue toxicity including tissue
cellulitis, fibrosis, and necrosis (common)
Rare Stomatitis pain (common), oedema (common) and
Vomiting, nausea, anorexia, erythema (common) as the result of
Not known
hiccups, diarrhea extravasation.
Hepatobiliary disorders
Hepatic enzymes increased, Reporting of suspected adverse reactions
Not known
blood bilirubin increased
Reporting suspected adverse reactions after
Skin and subcutaneous tissue disorders
authorisation of the medicinal product is
Not known Rash, alopecia important. It allows continued monitoring of
Musculoskeletal, connective tissue and the benefit/risk balance of the medicinal
bone disorders product.
Not known Muscle spasms
Renal and urinary disorders 4.9 Overdose
Renal failure acute, renal
Not known
failurec, renal tubular disorder
 Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200 mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

CAUTION IS ESSENTIAL IN ORDER Cisplatin Taj Pharma's oncolytic functions

TO PREVENT AN INADVERTENT can be compared to the functions of
OVERDOSE. alkylating substances. Cisplatin Taj Pharma
also offers immunosuppressive,
An acute overdose of Cisplatin Taj Pharma radiosensitising and antibacterial features.
may result in renal failure, liver failure,
deafness, ocular toxicity (including Cisplatin Taj Pharma does not seem to be
detachment of the retina), significant cell cycle specific.
myelosuppression, untreatable nausea and
vomiting and/or neuritis. An overdose may The cytotoxic activities of Cisplatin Taj
be fatal. Pharma are caused by binding all DNA
bases, with a preference for the N-7 position
There is no specific antidote in the event of of guanine and adenosine.
a Cisplatin Taj Pharma overdose. Even if
hemodialysis is initiated 4 hours after the 5.2 Pharmacokinetic properties
overdose it has little effect on the
elimination of Cisplatin Taj Pharma from Distribution
the body due to a strong and rapid fixation
of Cisplatin Taj Pharma to proteins. After intravenous administration, Cisplatin
Taj Pharma is rapidly distributed among all
5. PHARMACOLOGICAL tissues. Following Cisplatin Taj Pharma
PROPERTIES doses of 20 to 120mg/m2, the concentrations
of platinum are highest in liver, prostate and
5.1 Pharmacodynamic properties kidney, somewhat lower in bladder,
muscles, testicle, pancreas and spleen and
Pharmacotherapeutic group: Antineoplastic lowest in bowel, adrenal, heart, lung,
agents / Platinum compounds cerebrum and cerebellum.

Mechanism of action Biotransformation

Cisplatin Taj Pharma is an anorganic Over 90% of the total plasma Cisplatin Taj
substance containing a heavy metal [cis- Pharma is bounded with protein after two
diamminedichloroplatinum(II)]. This hours following the administration. This
substance inhibits the DNA synthesis by process may be irreversible. The protein-
realising transverse connections within and bounded part is not antineoplastic active.
between the DNA strings. The protein and Cisplatin Taj Pharma is non-linearly
RNA synthesis is inhibited to a lesser extent. pharmacokinetic. Cisplatin Taj Pharma is
converted by a non-enzymatic process into
Pharmacodynamic effects one or more metabolites. Elimination from
the plasma is realised in two phases after
Although the primary activity of Cisplatin intravenous bolus injection of 50-
Taj Pharma seems to be the inhibition of 100mg/m2 of Cisplatin Taj Pharma. The
DNA synthesis, the antineoplastic process following half-life period have been
includes other activities, such as registered for humans:
enlargement of the tumour immunogenicity.
 Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200 mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

t ½ (distribution): 10-60 minutes Studies in rats showed that exposure during

pregnancy produces tumours in the adult
t ½ (terminal): approximately 2-5 days offspring.

Elimination Pregnancy and lactation: Cisplatin Taj

Pharma is embryotoxic and teratogenic for
The considerable protein binding of the total mice and rats, and defects have been
platinum contents results in an extended or reported for both species. Cisplatin Taj
incomplete excretion phase with cumulative Pharma was found in the milk.
urine secretion ranging from 27 to 45% of
the administered dose in a period from 84 to 6. PHARMACEUTICAL
120 hours. An extended injection results in PARTICULARS
the urine secretion of a larger part of the
dose. The faecal secretion is minimal, and 6.1 List of excipients
small amounts of platinum can be traced in
the gallbladder and the large intestine. Sodium chloride, Hydrochloric acid,Water
Dysfunctional kidneys increase the plasma for injections.
half-life period, which may also increase
theoretically in the presence of ascites 6.2 Incompatibilities
caused by the highly protein binding
activities of Cisplatin Taj Pharma. Cisplatin Taj Pharma reacts with aluminium
which results in production of a black
5.3 Preclinical safety data platinum precipitate. Therefore any device
containing aluminium that may come in
Chronic toxicity: contact with Cisplatin Taj Pharma (sets for
intravenous injection, needles, catheters,
Chronic toxicity models indicate kidney syringes) must be avoided.
damage, bone marrow depression, gastro-
intestine disorders and ototoxicity. This medicinal product must not be mixed
with other medicinal products except those
Mutagenity and carcinogenity: mentioned in section 6.6.

Cisplatin Taj Pharma is mutagenic in The Cisplatin Taj Pharma 1mg/ml

numerous in vitro and in vivo tests (bacterial concentrate must not be diluted with glucose
test systems and chromosome defects in solution 5% alone or mannitol solution 5%
animal cells and tissue cultures). Long term alone, but only with the mixtures containing
studies of Cisplatin Taj Pharma on mice and additionally sodium chloride as stated in
rats evidenced the carcinogenic effects. section 6.6.

Reproductive toxicity: Antioxidants (such as sodium

metabisulphite), bicarbonates (sodium
Fertility: Gonadal suppression resulting in bicarbonate), sulfates, fluorouracil and
amenorrhoea or azoospermia may be paclitaxel may inactivate Cisplatin Taj
irreversible and cause definitive infertility. Pharma in injection systems.
 Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200 mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

6.3 Shelf life Packs of 1, 5 or 10 vial(s) containing 10ml,

20ml, 50ml, 100ml or 200ml Cisplatin Taj
Medicinal product as packaged for sale: Pharma solution for injection each.

2 years Not all pack sizes may be marketed.

Solution for injection after dilution (see 6.6 Special precautions for disposal and
section 6.6): other handling

Chemical and physical in-use stability has Cisplatin Taj Pharma 1mg/ml Cisplatin Taj
been demonstrated for 48 hours at 2 Pharma solution for injection is to be diluted
to 8°C when protected from light for before use. For preparation of solution for
solutions with a final Cisplatin Taj Pharma injection, any device containing aluminium
concentration of 0.1mg/ml after dilution of that may come in contact with Cisplatin Taj
the Cisplatin Taj Pharma 10mg/20ml Pharma (sets for intravenous injection,
concentrate with one of the following needles, catheters, syringes) must be
solutions: avoided (see section 6.2.).

- sodium chloride solution 0.9%; Preparation of solution for injection must

- mixture of sodium chloride solution take place in aseptic conditions.
0.9% and glucose solution 5% (1:1);
- mixture of sodium chloride solution For dilution of the concentrate, one of the
0.9% and mannitol solution 5% (1:1). following solutions should be used:

From a microbiological point of view, the - sodium chloride solution 0.9%;

product should be used immediately. If not - mixture of sodium chloride solution
used immediately, in-use storage times and 0.9% and glucose solution 5% (1:1)
conditions prior to use are the responsibility (resulting final concentrations: sodium
of the user and would normally not be chloride 0.45%, glucose 2.5%).
longer than 24 hours at 2 to 8°C, unless - Should hydration prior to the treatment
reconstitution / dilution (etc) has taken place with Cisplatin Taj Pharma be
in controlled and validated aseptic impossible, the concentrate may be
conditions. diluted with:
- mixture of sodium chloride solution
6.4 Special precautions for storage 0.9% and mannitol solution 5% (1:1)
(resulting final concentrations: sodium
Medicinal product as packaged for sale: chloride 0.45%, mannitol 2.5%).

Do not store above 25 °C. Do not refrigerate Preparation of Cisplatin Taj Pharma solution
or freeze. Keep the vial in the outer carton. for injection:

For storage conditions of the diluted The required amount (dose) of the Cisplatin
medicinal product, see section 6.3. Taj Pharma concentrate 1mg/ml calculated
according to the instructions in section 4.2.
6.5 Nature and contents of container
 Cis platin Injection B P 10mg/ 10ml, 10 mg/ 20ml, 50mg/ 50ml, 5 0mg/ 100ml, 100 mg/ 100ml, 200 mg/ 200ml Injectio n TajPhar ma : U s es -Anti-cancer, Side E ffects -naus ea and v omiting, I nterac tions , Pictur es , W arnings , Cis platin Dos age & Rx Info | Cis pla tin U s es , Side Effects - naus ea and vomiting, Cis platin : Indicati ons -To t reat t umou r of tes tis and overy, Side Ef fects - naus ea and vomi ting, W arnings , Cis platin - D rug Info rmati on - TajPha rma, Cis plati n dos e Taj phar maceuticals Cis platin inte ractions , Taj Pha rmaceutical Cis platin con train dications , Cis platin p rice, Cis platin TajPha rma anti ps ychotics Cis platin 10mg/ 10ml, 10mg/ 20ml, 50 mg/ 50ml, 50mg/ 100 ml, 100mg/ 100ml, 2 00mg/ 200ml Injec tion SMP C- TajPha rma Stay conn ected t o all update d on Cis platin Taj P harmaceu ticals Taj pharmaceuticals , Patie nt Inf orma tion Leafle ts , SMPC.

should be diluted in 1-2 litres of one of the Manufactured in India By:

above mentioned solutions. TAJ PHARMACEUTICALS LIMITED
at SURVEY NO.188/1 TO 189/1,190/1 TO
The diluted solution should be administered 4, ATHIYAWAD, DABHEL, DAMAN-
only by intravenous injection (see section 396210 (INDIA).
4.2.). Only clear and colourless to yellowish
solutions without visible particles should be
used.

For single use only.

Cytotoxic agents should be prepared for

administration only by personnel who have
been trained in the safe handling of the
preparation.

Refer to local cytotoxic handling guidelines.

As any other cytotoxic agent, Cisplatin Taj

Pharma should be used with extreme
caution: gloves, face masks and protective
clothing are required and vital. Cisplatin Taj
Pharma should be processed under a
protective hood, if possible. Contact with
skin and/or mucous membranes must be
avoided. Pregnant hospital employees
should not work with Cisplatin Taj Pharma.

Skin contact: Rinse with large quantities of

water. Apply an ointment if you have a
temporary burning feeling. (Note: Some
persons are sensitive to platinum and may
experience a skin reaction).

In the event of spillage, operators should put

on gloves and mop up the spilled material
with a sponge kept in the area for that
purpose. Rinse the area twice with water.
Put all solutions and sponges into a plastic
bag and seal it. In the case of spillage all
items coming into contact with Cisplatin Taj
Pharma should be handled and disposed in
accordance to local cytotoxic guidelines.