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Each mg of Protamine Sulfate will neutralize approximately 90 units of heparin activity derived from beef lung tissue or about 115 units of heparin activity derived from porcine intestinal mucosa.
Protamine Sulfate Injection, should be given by very slow intravenous injection in doses not to exceed 50 mg of Protamine Sulfate in any 10 minute period.
Protamine Sulfate is intended for injection without further dilution; however,if further dilution is desired, 5% Dextrose Injection,or 0.9% Sodium Chloride Injection may be used. Diluted solutions should not be stored since they contain no preservative.
Protamine Sulfate should not be mixed with other drugs without knowledge of their compatibility, because Protamine Sulfate has been shown to be incompatible with certain antibiotics,including several of the cephalosporins and penicillins.
Because heparin disappears rapidly from the circulation, the dose of Protamine Sulfate required also decreases rapidly with the time elapsed following intravenous injection of heparin.For example, if the Protamine Sulfate is administered 30 minutes after the heparin, one-half the usual dose may be sufficient.
The dosage of Protamine Sulfate should be guided by blood coagulation studies.Parenteral drug products should be visually inspected for particulate matter and discolouration prior to administration, whenever solution and container permit.
Usage in Children: Safety and effectiveness in children have not been established.
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