THROMBIN-JMI® Warnings and Precautions

(thrombin, topical, bovine origin)

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

•
Allergic reactions, including anaphylactic/anaphylactoid reactions, have been reported following administration of THROMBIN-JMI.
•
Institute intensive supportive measures and treat individual symptoms. Secure the airway and establish adequate respiratory exchange.

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.

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Warnings and Precautions

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

•
Allergic reactions, including anaphylactic/anaphylactoid reactions, have been reported following administration of THROMBIN-JMI.
•
Institute intensive supportive measures and treat individual symptoms. Secure the airway and establish adequate respiratory exchange.

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.
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Health Professional Information

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