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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