THROMBIN-JMI® Boxed Warning

(thrombin, topical, bovine origin)

WARNING: SEVERE BLEEDING AND THROMBOSIS COMPLICATIONS

THROMBIN-JMI can cause fatal severe bleeding or thrombosis. Thrombosis may result from the development of antibodies against bovine thrombin. Bleeding may result from the development of antibodies against factor V. These may cross-react with human factor V and lead to its deficiency. (5.2, 5.3)
Do not re-expose patients to THROMBIN-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V. (4, 5.3)
Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis. (5.3)

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Boxed Warning

WARNING: SEVERE BLEEDING AND THROMBOSIS COMPLICATIONS

THROMBIN-JMI can cause fatal severe bleeding or thrombosis. Thrombosis may result from the development of antibodies against bovine thrombin. Bleeding may result from the development of antibodies against factor V. These may cross-react with human factor V and lead to its deficiency. (5.2, 5.3)
Do not re-expose patients to THROMBIN-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V. (4, 5.3)
Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis. (5.3)
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