Thrombate
DRUG DESCRIPTION
Antithrombin III (Human), THROMBATE III® is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III.
THROMBATE III is prepared from pooled units of human plasma from normal donors by modifications and refinements of the cold ethanol method of Cohn.1 When reconstituted with Sterile Water for Injection, USP, THROMBATE III has a pH of 6.0-7.5, a sodium content of 110-210 mEq/L, a chloride content of 110-210 mEq/L, an alanine content of 0.075-0.125 M and a heparin content of not more than 0.004 unit/IU AT-III. THROMBATE III contains no preservative and must be administered by the intravenous route. In addition, THROMBATE III has been heat-treated in solution at 60°C ± 0.5°C for not less than 10 hours.
Each vial of THROMBATE III contains the labeled amount of antithrombin III in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a World Health Organization (WHO) antithrombin III reference preparation.
Generic Name: Antithrombin
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