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Product Details
Product Name : PROTAMINE SULPHATE INJ
Brand Name : Protide
Model Name :
Product Features : PRESENTATION : PROTIDE is supplied as Protamine Sulphate I.P. 10 mg/ml in 5 ml aqueous solution. Such 5 vials are packed in a box.
Technical Details : PROTAMINE SULPHATE INJECTION I.P. 50mg / 5ml vial Neutralisation of the Anticoagulant Effect of Heparin Specification : CHEMISTRY : Protamine Sulphate DESCRIPTION OF INJECTION : PROTIDE is a clear, colourless solution filled in 5 ml flint tubular vial. PHARMACOLOGY : When administered alone, protamine has an anticoagulant effect. However, when it is given in the presence of heparin (which is strongly acidic), a stable salt is formed and the anticoagulant activity of both drugs is lost. INDICATIONS : 1. Protamine sulphate is indicated in the treatment of heparin overdosage. DOSAGE AND ADMINISTRATION : Administration : By slow intravenous injection only. Dosage : Protamine Sulphate Injection should be given by very slow intravenous injection over a 10-minute period in doses not to exceed 50 mg. Protamine sulphate is intended for injection without further dilution; however, if further dilution is desired, 5 % Dextrose in Water or Normal Saline may be used. Diluted solutions should not be stored since they contain no preservative. Because heparin disappears rapidly from the circulation, the dose of protamine sulphate required also decreases rapidly with the time elapsed following intravenous injection of heparin. For example, if protamine sulphate is administered 30 minutes after heparin, one half the usual dose may be sufficient. The dosage of protamine sulphate should be guided by blood coagulation studies. CONTRAINDICATIONS : Protamine sulphate is contraindicated in patients who have shown previous intolerance to the drug. WARNINGS : Hyperheparinemia or bleeding : Hyperheparinemia or bleeding has been reported in experimental animals and in some patients 30 minutes to 18 hours after cardiac surgery (under cardiopulmonary bypass) in spite of complete neutralization of heparin by adequate doses of protamine sulphate at the end of the operation. It is important to keep the patient under close observation after cardiac surgery. Additional doses of protamine sulphate should be administered if indicated by coagulation studies, such as the heparin titration test with protamine and the determination of plasma thrombin time. Too-rapid administration of protamine sulphate can cause severe hypotensive and anaphylactoid reactions. Facilities to treat shock should be available. PREGNANCY AND LACTATION : Pregnancy Category C : Animal reproduction studies have not been conducted with protamine sulphate. It is also not known whether protamine sulphate can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Nursing Mothers : It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when protamine sulphate is administered to a nursing woman. Paediatric Use : Safety and effectiveness in paediatric patients have not been established. ADVERSE REACTIONS : The intravenous administration of protamine sulphate may cause a sudden fall in blood pressure and bradycardia. Other reactions include transitory flushing and feeling of warmth, dyspnoea, nausea, vomiting, and lassitude. Back pain has been reported in conscious patients undergoing such procedures as cardiac catheterization. Severe adverse reactions have been reported including : 1. Anaphylaxis that resulted in severe respiratory distress, circulatory collapse and capillary leak. Fatal anaphylaxis has been reported in one patient with no prior history of allergies; 2. Anaphylactoid reactions with circulatory collapse, capillary leak, and noncardiogenic pulmonary oedema; acute pulmonary hypertension. Complement activation by the heparin-protamine complexes, release of lysosomal enzymes from neutrophils, and prostaglandin and thromboxane generation have been associated with the development of anaphylactoid reactions. DRUG INTERACTIONS : Antibiotics : Protamine sulphate has been shown to be incompatible with certain antibiotics, including several of the cephalosporins and penicillins. STORAGE CONDITION : Store in a refrigerator between 2°C and 8°C (35.6°F and 46.4° F). Do not freeze. PRESENTATION : PROTIDE is supplied as Protamine Sulphate I.P. 10 mg/ml in 5 ml aqueous solution. Such 5 vials are packed in a box.
Fact Sheet
Year of Incorporation : 1947
Countries of Export : more than 25 countries in South America, Central America, Caribbean, South East Asia, West Africa &
Quality Certification : -



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