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THROMBIN-JMI
Bleeding disorders
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Drug Name:

THROMBIN-JMI Rx

Generic Name and Formulations:
Thrombin [bovine origin] 5000 IU, 20000 IU; per vial; pwd for topical use after reconstitution; preservative-free.

Company:
Pfizer Inc.

Therapeutic Use:

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.

Adult:

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.

Children:

Not established.

Contraindications:

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.

Boxed Warning:

Severe bleeding and thrombosis complications.

Warnings/Precautions:

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.

Pharmacological Class:

Topical hemostatic.

Adverse Reactions:

Hypersensitivity reactions, bleeding, anemia, post-op wound infection, thromboembolic events, hypotension, pyrexia, tachycardia, thrombocytopenia.

How Supplied:

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


Data provided by MPR.

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