EVITHROM™ Thrombin, Topical (Human) for Topical Use Only

Indications and Usage
EVITHROM™ 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 is ineffective or impractical.

EVITHROM™ may be used in conjunction with an Absorbable Gelatin Sponge, USP.

Important Safety Information
Do not inject EVITHROM™ directly into the circulatory system. Do not use for the treatment of severe or brisk arterial bleeding. Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. EVITHROM™ is prepared from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

There is a potential risk of thrombosis if absorbed systemically.

Anaphylactic reactions may occur.

Adverse events were reported in the clinical trial with similar frequency in the two study groups (EVITHROM™ or bovine thrombin group). The most common adverse event reported was procedural complications and pruritus. None of the adverse events reported was considered causally related to EVITHROM™ administration.

Immunogenicity was evaluated by testing for the development of antibodies to highly purified antigens: human thrombin, human Factor V/Va, bovine thrombin and bovine Factor V/Va. None of the patients treated with EVITHROM™ developed antibodies to human thrombin or to human Factor V/Va.

Direct comparison of incidence of antibody development following administration of EVITHROM™ with incidence of antibody development following administration of other products may be misleading and the clinical significance of these findings is unknown.

Please see Full Prescribing Information.

Manufactured by OMRIX biopharmaceuticals Ltd. Israel License No. 1603 US-2007/09/039

Distributed by Johnson & Johnson Wound Management A division of ETHICON, INC. Route 22 West Somerville, NJ 08876