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THROMBIN-JMI® (thrombin, topical, bovine origin) Warnings and Precautions

5 WARNINGS AND PRECAUTIONS

Warning: Severe Bleeding and Thrombosis Complications

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. Apply topically. DO NOT INJECT.

5.3 Immunogenicity

Inhibitory antibodies may develop in patients and interfere with hemostasis. Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.

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