Thrombin topical recombinant

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. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.

RECOTHROM Thrombin topical (Recombinant), is a specific human serine protease that promotes hemostasis and acts locally when applied topically to a site of bleeding. RECOTHROM activates platelets and catalyzes the conversion of fibrinogen to fibrin, which are steps that are essential for blood clot formation.

For topical use only. DO NOT INJECT. For topical use only. DO NOT INJECT. • Reconstitute RECOTHROM Thrombin topical (Recombinant) powder with sterile 0.9% sodium chloride, USP, yielding a solution containing 1,000 units (international units of potency) per mL. • Apply RECOTHROM solution with absorbable gelatin sponge or RECOTHROM Spray Applicator Kit directly to the bleeding site surface. The amount required depends upon the area of tissue to be treated. • 5,000-unit RECOTHROM may be used in conjunction with FLOSEAL NT Hemostatic Matrix, 5mL

• 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 Thrombin topical (Recombinant) or any components of RECOTHROM. • Do not use in patients with known hypersensitivity to hamster proteins. • 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 Thrombin topical (Recombinant), any components of RECOTHROM or hamster proteins.

• RECOTHROM Thrombin topical (Recombinant) causes thrombosis if it enters the circulatory system. • Hypersensitivity reactions, including anaphylaxis, may occur.

Thromboembolic adverse reactions were reported in 6% of surgical patients treated with RECOTHROM Thrombin topical (Recombinant) in all completed clinical trials (N=644). Antibody formation to RECOTHROM occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin. • The most common adverse reaction (incidence 6%) was thromboembolic events. • Antibody formation to RECOTHROM Thrombin topical (Recombinant) occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin.

Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze. Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F).