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CROFAB is supplied as a carton that contains 2 vials of product (diluent not included) [NDC 50633-110-12]. Each vial of CROFAB contains up to 1 gram of lyophilized total protein and not less than the indicated number of mouse LD50 neutralizing units:
|Snake Species Used for Antivenin Component||Minimum mouse LD50 Units per vial|
|C. atrox (Western Diamondback rattlesnake)||1270|
|C. adamanteus (Eastern Diamondback rattlesnake)||420|
|C. scutulatus (Mojave rattlesnake)||5570|
|A. piscivorus (Cottonmouth or Water Moccasin)||780|
Storage and Handling
- Store vials at 2° to 8°C (36° to 46°F). A temperature excursion for no longer than 7 days within the range of -20° to 25°C (-4° to 77°F) is permitted.
- Do not freeze.
- Use within 4 hours after reconstitution.
- Advise patients to contact their physician immediately if they experience unusual bruising or bleeding (e.g., nosebleeds, excessive bleeding after brushing teeth, the appearance of blood in stools or urine, excessive menstrual bleeding, petechiae, excessive bruising or persistent oozing from superficial injuries) after hospital discharge.Such bruising or bleeding may occur for up to 1 week or longer following initial treatment.
- Advise patients to contact their physician immediately if they experience any signs and symptoms of delayed allergic reactions or serum sickness (e.g., rash, pruritus, urticaria) after hospital discharge.
and distributed by:
BTG International Inc.
West Conshohocken, PA 19428
U.S. License No. 1861
CroFab® is a registered trademark of BTG International Inc.
|CROFAB ovine crotalidae venoms immune fab injection, powder, lyophilized, for solution|
|Labeler — BTG International Inc. (617382395)|
|Cangene BioPharma, LLC||050783398||MANUFACTURE (50633-110)|
|Protherics UK Limited||536591589||ANALYSIS (50633-110), API MANUFACTURE (50633-110)|
Revised: 11/2022 BTG International Inc.
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