Antithrombin III (Human), THROMBATE III® (antithrombin) is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III.

THROMBATE (antithrombin) 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 (antithrombin) 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 (antithrombin) III contains no preservative and must be administered by the intravenous route. In addition, THROMBATE (antithrombin) 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.

The manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.24-27

An individual production step in the THROMBATE (antithrombin) III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 logs). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

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