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Amoxgentin - amoxycillin & potassium clavulanate injection - export 1.2g I.V
PACK
Amoxgentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):
• Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms)
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Cystitis
• Pyelonephritis
• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis
• Bone and joint infections, in particular osteomyelitis
• Intra-abdominal infections
• Female genital infections.
Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the:
• Gastrointestinal tract
• Pelvic cavity
• Head and neck
• Biliary tract surgery.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactam agents (see sections 4.3 and 4.8).
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs, amoxicillin/clavulanic acid therapy must be discontinued and appropriate alternative therapy instituted.
In the case that an infection is proven to be due to an amoxicillin-susceptible organisms(s) then consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin in accordance with official guidance.
This presentation of Amoxgentin may not be suitable for use when there is a high risk that the presumptive pathogens have resistance to beta-lactam agents that is not mediated by beta-lactamases susceptible to inhibition by clavulanic acid. As no specific data for T>MIC are available and the data for comparable oral presentations are borderline, this presentation (without additional amoxicillin) may not be suitable for the treatment of penicillin-resistant S. pneumoniae.
Convulsions may occur in patients with impaired renal function or in those receiving high doses (see section 4.8).
Amoxicillin/clavulanic acid should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP) (see Section 4.8). This reaction requires Amoxgentin discontinuation and contraindicates any subsequent administration of amoxicillin.
Amoxicillin/clavulanic acid should be used with caution in patients with evidence of hepatic impairment (see sections 4.2, 4.3 and 4.8).
Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children. In all populations, signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased. These are usually reversible. Hepatic events may be severe, and in extremely rare circumstances, deaths have been reported. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for
Originaltitel
Amoxgentin - Amoxycillin & Potassium Clavulanate Injection - Export 1.2g I.v - Info
Amoxgentin - amoxycillin & potassium clavulanate injection - export 1.2g I.V
PACK
Amoxgentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):
• Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms)
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Cystitis
• Pyelonephritis
• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis
• Bone and joint infections, in particular osteomyelitis
• Intra-abdominal infections
• Female genital infections.
Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the:
• Gastrointestinal tract
• Pelvic cavity
• Head and neck
• Biliary tract surgery.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactam agents (see sections 4.3 and 4.8).
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs, amoxicillin/clavulanic acid therapy must be discontinued and appropriate alternative therapy instituted.
In the case that an infection is proven to be due to an amoxicillin-susceptible organisms(s) then consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin in accordance with official guidance.
This presentation of Amoxgentin may not be suitable for use when there is a high risk that the presumptive pathogens have resistance to beta-lactam agents that is not mediated by beta-lactamases susceptible to inhibition by clavulanic acid. As no specific data for T>MIC are available and the data for comparable oral presentations are borderline, this presentation (without additional amoxicillin) may not be suitable for the treatment of penicillin-resistant S. pneumoniae.
Convulsions may occur in patients with impaired renal function or in those receiving high doses (see section 4.8).
Amoxicillin/clavulanic acid should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP) (see Section 4.8). This reaction requires Amoxgentin discontinuation and contraindicates any subsequent administration of amoxicillin.
Amoxicillin/clavulanic acid should be used with caution in patients with evidence of hepatic impairment (see sections 4.2, 4.3 and 4.8).
Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children. In all populations, signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased. These are usually reversible. Hepatic events may be severe, and in extremely rare circumstances, deaths have been reported. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for
Amoxgentin - amoxycillin & potassium clavulanate injection - export 1.2g I.V
PACK
Amoxgentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):
• Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms)
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Cystitis
• Pyelonephritis
• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis
• Bone and joint infections, in particular osteomyelitis
• Intra-abdominal infections
• Female genital infections.
Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the:
• Gastrointestinal tract
• Pelvic cavity
• Head and neck
• Biliary tract surgery.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactam agents (see sections 4.3 and 4.8).
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and in atopic individuals. If an allergic reaction occurs, amoxicillin/clavulanic acid therapy must be discontinued and appropriate alternative therapy instituted.
In the case that an infection is proven to be due to an amoxicillin-susceptible organisms(s) then consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin in accordance with official guidance.
This presentation of Amoxgentin may not be suitable for use when there is a high risk that the presumptive pathogens have resistance to beta-lactam agents that is not mediated by beta-lactamases susceptible to inhibition by clavulanic acid. As no specific data for T>MIC are available and the data for comparable oral presentations are borderline, this presentation (without additional amoxicillin) may not be suitable for the treatment of penicillin-resistant S. pneumoniae.
Convulsions may occur in patients with impaired renal function or in those receiving high doses (see section 4.8).
Amoxicillin/clavulanic acid should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP) (see Section 4.8). This reaction requires Amoxgentin discontinuation and contraindicates any subsequent administration of amoxicillin.
Amoxicillin/clavulanic acid should be used with caution in patients with evidence of hepatic impairment (see sections 4.2, 4.3 and 4.8).
Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children. In all populations, signs and symptoms usually occur during or shortly after treatment but in some cases may not become apparent until several weeks after treatment has ceased. These are usually reversible. Hepatic events may be severe, and in extremely rare circumstances, deaths have been reported. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for
AMOXGENTIN IS ANTHIBACTERIAL COMBINATION CONSISTING OF
AMOXICILLIN (AS SODIUM) AND THE BETALACTAMASE INHIBITOR, CLAVULANIC ACID (AS POTASSIUM CLAVULANATE).
1.2g
Amoxgentin IV vials are not suitable for intramuscular of
subcutaneous administration. Amoxgentin IV vials should be given by slow intravenous injection over a period of three to four minutes. It may be injected directly into a vein or via a drop tube. Use Reconstituted Solution within 20 Minutes, Discard any unused Solution. Duration of therapy should be appropriate to the indication and should not exceed 14 days without review.
1000 MG/200 MG IV:
DISSOLVE THE POWDER IN 10ML WATER FOR INJECTION USES: AMOXICILLIN IS USED TO TREAT A WIDE VARIETY OF BACTERIAL INFECTIONS. THIS MEDICATION IS A PENICILLIN-TYPE ANTIBIOTIC. IT WORKS BY STOPPING THE GROWTH OF BACTERIA.THIS ANTIBIOTIC TREATS ONLY BACTERIAL INFECTIONS. IT WILL NOT WORK FOR VIRAL INFECTIONS (SUCH AS COMMON COLD, FLU).
Dosage: As directed by the Physician.
Keep in a cool dry place Do not Store above 30oC, Protect from light
STORE AWAY FROM HEAT, MOISTURE,
AND LIGHT. DO NOT STORE IN THE BATHROOM. KEEP AMOXGENTIN OUT OF THE REACH OF CHILDREN AND AWAY FROM PETS.
1.2g
Manufactured and Exported By:
TAJ PHARMACEUTICALS LIMITED Mumbai., India
for reconstitution as an intravenous
Amoxgentin 1.2g injection or infusion.
TPL-6678-657 AMX
Amoxgentin 1.2g
Amoxycillin & Clavulanate Potassium
1.2g I.V. Injection
for reconstitution as an intravenous
injection or infusion.
1.2g
1000 MG/200 MG IV:
DISSOLVE THE POWDER IN 10ML WATER FOR INJECTION Dosage: As directed by the Physician. Keep in a cool dry place Do not Store above 30oC, Protect from light Manufactured and Exported By: TAJ PHARMACEUTICALS LIMITED Mumbai., India
TPL-6678-657 AMX
Amoxgentin 1.2g
Amoxycillin & Clavulanate Potassium
1.2g I.V. Injection
for reconstitution as an intravenous
injection or infusion.
1.2g
1000 MG/200 MG IV:
DISSOLVE THE POWDER IN 10ML WATER FOR INJECTION Dosage: As directed by the Physician. Keep in a cool dry place Do not Store above 30oC, Protect from light Manufactured and Exported By: TAJ PHARMACEUTICALS LIMITED Mumbai., India
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