Home | Important Safety Information

Thrombin-JMI® (Thrombin, Topical, Bovine Origin, U.S.P.) is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible. In various types of surgery, solutions of Thrombin-JMI® may be used in conjunction with an Absorbable Gelatin Sponge, USP for hemostasis.

 

Thrombi-Pad™ (3x3 hemostatic pad) is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters and tubes.
Please see the Instructions for Use.

 

Thrombi-Gel® (thrombin/gelatin foam hemostat) is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters and tubes.
Please see the Instructions for Use.

 

Important Safety Information
Because of its action in the clotting mechanism, Thrombin-JMI® must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting and even death may result.

Occasionally, the use of topical bovine thrombin preparations has been associated with abnormalities in hemostasis ranging from alterations in prothrombin time (PT) and partial thromboplastin time (PTT) to severe bleeding or thrombosis. These hemostatic effects have rarely been fatal and appear to be related to the formation of cross-reacting bovine antibodies to thrombin and/or factor V. Consultation with an expert in coagulation disorders is recommended if a patient exhibits any of these abnormalities following the use of topical thrombin, particularly following repeat application. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.

Thrombin-JMI® should be given to a pregnant woman only if clearly indicated. Safety and effectiveness in children have not been established.

 

For additional Important Safety Information, please see the full Prescribing Information.

 

 

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