RECOTHROM, Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age.
IMPORTANT SAFETY INFORMATION
- Do not inject directly into the circulatory system
- Do not use for the treatment of massive or brisk arterial bleeding
- Do not administer to patients with a history of hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins
Warnings and Precautions
- RECOTHROM may cause thrombosis if it enters the circulatory system. Apply topically. DO NOT INJECT
- Hypersensitivity reactions, including anaphylaxis, may occur
- The most common adverse reaction (incidence 6%) was thromboembolic events
- Antibody formation to RECOTHROM occurred in < 1% of patients. None of the antibodies detected neutralized native human thrombin
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