"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
THROMBIN, TOPICAL U.S.P.
THROMBIN-JMI (thrombin topical bovine origin) ®
Thrombin, Topical (Bovine) must not be injected! Apply on the surface of bleeding tissue.
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.
Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Thrombin-JMI Information
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