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Oscar-Nominated True Grit Gets Top Reviews for Acting but Mixed Reviews for Snakebite Treatment
Date:2/25/2011

mous pit viper bite."

About CroFab®

CroFab® Crotalidae Polyvalent Immune Fab (ovine) is an antivenom used for the management of patients with North American crotalid envenomation.  Crotalid snakes include rattlesnakes, copperheads and cottonmouths/water moccasins.  This antidote is appropriate for use in the great majority of U.S. snakebites, outside of the coral snake.  Early use of CroFab® (within 6 hours of snakebite) is advised to prevent a patient's clinical deterioration and the occurrence of systemic blood-clotting (coagulation) abnormalities.

Important Safety Information

The most common adverse events reported in clinical studies were mild or moderate reactions involving the skin and appendages (primarily urticaria, rash, or pruritus), which occurred in 14 out of 42 patients. Three patients experienced a serious adverse event. Two patients had a severe allergic reaction (severe hives and a severe rash and pruritus) following treatment.  One patient had a recurrent coagulopathy due to envenomation, which required rehospitalization and additional antivenom administration.  In clinical trials, recurrent coagulopathy (the return of a coagulation abnormality after it has been successfully treated with antivenom), characterized by decreased fibrinogen, decreased platelets, and elevated prothrombin time, occurred in approximately half of the patients studied.  Recurrent coagulopathy may persist for 1 to 2 weeks or more.  One patient discontinued CroFab® therapy due to an allergic reaction.  Patients with allergies to papain, chymopapain, other papaya extracts, or the pineapple enzyme bromelain may also be at risk for an allergic reaction to CroFab®.  

For CroFab® full prescribing information, visit:  http://www.crofab.com

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SOURCE BTG International Inc.
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