Composition
Each 5 ml or 10 ml vial contains:
Protamine sulphate ...................... 10 mg/ml

Therapeutic Indications
Treatment of heparin overdosage. To neutralize the effect of heparin given before surgery and during extracorporeal circulation, as in dialysis or cardiac surgery.

Dosage and Administration
Dosage is based on venous blood coagulation studies, dependent on the amount of heparin to be neutralised.
Usually 1 mg Protam for each 90 to 115 units of heparin. Maximum dose is 50 mg.
Protam is administered by slow IV injection over a period of about 10 minutes.
As heparin is being continuously excreted, the dose should be reduced if more than 15 minutes have elapsed since heparin administration, e.g., if Protam is given 30 minutes after heparin, the dose may be reduced to about one-half.

Contraindications
Hypersensitivity to the product.

Warnings and Precautions
Protam should be used with caution in the following conditions:
After cardiac surgery; observe patient closely. Additional doses of Protam should be given if indicated by coagulation studies.
Pregnancy; may be used only if clearly needed.
Breastfeeding women.
Safety and efficacy of the drug have not been established in children.
Excessively rapid IV administration can cause severe hypotensive and anaphylactoid reactions. Have facilities available to treat shock.
Hypersensitivity reactions can occur in diabetics who have received protamine-insulin preparations