ZymoGenetics, Inc., a Bristol-Myers Squibb Company

Product Name:

RECOTHROM Thrombin, topical (Recombinant)

Product Description:

INDICATION

RECOTHROM Thrombin, topical (Recombinant) is indicated as an aid to 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.

IMPORTANT SAFETY INFORMATION

Contraindications

• Topical use only – DO NOT INJECT directly into the circulatory system

• Do not use for the treatment of massive or brisk arterial bleeding or in patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins

Warnings and Precautions

• Potential risk of thrombosis if absorbed systemically

• In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction

Adverse Reactions

• The serious adverse event that occurred in >=1% (n=6/583) of patients exposed to RECOTHROM in completed clinical trials was atrial fibrillation. The most common adverse events reported in these trials (N=583) were incision site pain (51%), procedural pain (30%), and nausea (28%). Adverse events reported in these trials were consistent with those commonly observed in surgical patients

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