5.2 Thrombosis
THROMBIN-JMI causes thrombosis if it enters the circulatory system due to its action in the clotting system.
Apply topically. DO NOT INJECT.
5.3 Immunogenicity
Inhibitory antibodies may develop in patients and interfere with hemostasis. Do not re-expose patients to THROMBIN-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V, due to the potential for these antibodies to interfere with hemostasis. Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.
Bleeding
Bleeding may result from the development of antibodies against factor V. These antibodies may cross-react with human factor V and lead to human factor V deficiency.
Thrombosis
Thrombosis may result from the development of antibodies against bovine thrombin.