(thrombin, topical, bovine origin)

Prescribing Information
Download Prescribing Information

Health Professional Information

Warnings and Precautions

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Allergic reactions, including anaphylactic/anaphylactoid reactions, have been reported following administration of THROMBIN-JMI.
Institute intensive supportive measures and treat individual symptoms. Secure the airway and establish adequate respiratory exchange.

5.2 Thrombosis

THROMBIN-JMI causes thrombosis if it enters the circulatory system due to its action in the clotting system.

Apply topically. DO NOT INJECT.

5.3 Immunogenicity

Inhibitory antibodies may develop in patients and interfere with hemostasis. Do not re-expose patients to THROMBIN-JMI if there are known or suspected antibodies to bovine thrombin and/or factor V, due to the potential for these antibodies to interfere with hemostasis. Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.

Bleeding

Bleeding may result from the development of antibodies against factor V. These antibodies may cross-react with human factor V and lead to human factor V deficiency.

Thrombosis

Thrombosis may result from the development of antibodies against bovine thrombin.

Medication Guide
Download Consumer Medicine Information

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.