Thrombin-JMI

DRUG DESCRIPTION

The thrombin in Thrombin, Topical (Bovine Origin) THROMBIN-JMI (thrombin topical bovine origin) is a protein substance produced through a conversion reaction in which prothrombin of bovine origin is activated by tissue thromboplastin of bovine origin in the presence of calcium chloride. It is supplied as a sterile powder that has been freeze-dried in the final container. Also contained in the preparation are mannitol and sodium chloride. Mannitol is included to make the dried product friable and more readily soluble. The material contains no preservative.

THROMBIN-JMI (thrombin topical bovine origin) has been chromatographically purified and further processed by ultrafiltration. Analytical studies demonstrate the current manufacturing process' capability to remove significant amounts of extraneous proteins, and result in a reduction of Factor Va light chain content to levels below the limit of detection of semi-quantitative Western Blot assay ( < 92 ng/mL, when reconstituted as directed). The clinical significance of these findings is unknown.



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