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Thrombin-JMI (Thrombin Topical) - Warnings and Precautions

 
 



PRECAUTIONS

General --Consult the Absorbable Gelatin Sponge, USP labeling for complete information for use prior to utilizing the thrombin saturated sponge procedure.

Pregnancy--Category C --Animal reproduction studies have not been conducted with THROMBIN-JMI®. It is also not known whether THROMBIN-JMI® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. THROMBIN-JMI® should be given to a pregnant woman only if clearly indicated.

Pediatric Use --Safety and effectiveness in children have not been established.

Page last updated: 2006-03-03

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