Generic Name and Formulations:
Thrombin [bovine origin] 5000 IU, 20000 IU; per vial; pwd for topical use after reconstitution; preservative-free.
Indications for THROMBIN-JMI:
Aid to hemostasis for oozing blood and minor bleeding from accessible capillaries and small venules. Adjunct for surgical hemostasis with absorbable gelatin sponge.
For topical use only. See full labeling. Profuse bleeding (eg, abraided surfaces of liver or spleen): 1000 IU/mL. General use (eg. plastic surgery, dental extractions, skin grafting): 100 IU/mL. May dilute to prepare intermediate strengths, if needed. Oozing surfaces: may use dry form.
Direct injection into the circulatory system. Re-exposure if there are known or suspected antibodies to bovine thrombin and/or factor V. Treatment of severe or brisk arterial bleeding.
Not for injection. Allergic reactions: have supportive measures available. Thrombosis. Antibody formation may interfere with hemostasis. Monitor for abnormal coagulation lab values, bleeding, thrombosis. Pregnancy. Nursing mothers.
Hypersensitivity reactions, bleeding, anemia, post-op wound infection, thromboembolic events, hypotension, pyrexia, tachycardia, thrombocytopenia.
Vials—1 (w. diluent); Pump Spray Kit (20000 IU)—1 (w. diluent); Syringe Spray Kit (5000 IU, 20000 IU)—1 (w. diluent); Epistaxis Kit (5000 IU)—1 (w. diluent); Gelfoam-JMI Kit (gelatin sponge or powder)—1