CroFab: Package Insert and Label Information (Page 3 of 3)

15 REFERENCES

  1. Consroe P, Egen NB, Russell FE, Gerrish K, Smith DC, Sidki A, et al. Comparison of a new ovine antigen binding fragment (Fab) antivenin for United States Crotalidae with the commercial antivenin for protection against venom induced lethality in mice. J Trop Med Hyg 1995; 53(5):507 510.
  2. Dart RC, Hurlbut KM, Garcia R, Boren J. Validation of a severity score for the assessment of Crotalid snakebite. Ann Emerg Med 1996; 27(3):321 326.
  3. Lavonas EJ, Ruha AM, Banner W, Bebarta V, Bernstein JN, Bush SP, Kerns WP, Richardson WH, Seifert SA, Tanen DA, Curry SC, Dart RC. Unified treatment algorithm for the management of crotaline snakebite in the United States: results of an evidence-informed consensus workshop. BMC Emerg Med February 3 2011;11:2 (http://www.biomedcentral.com/1471-227X/11/2).
  4. La Grange RG and Russell FE. Blood platelet studies in man and rabbits following Crotalus envenomation. Proc West Pharmacol Soc 1970;13:99-105.
  5. Lyons WJ. Profound thrombocytopenia associated with Crotalus ruber ruber envenomation: a clinical case. Toxicon 1971; 9:237 240.
  6. Tallon RW, Koch KL, Barnes SG, Ballard JO. Letter to Editor. N Engl J Med 1981;305:1347.
  7. Quarre JP, Lecomte J, Lauwers D, Gilbert P, Thiriaux J. Allergy to latex and papain. J Allergy Clin Immunol 1995; 95(4):922.
  8. Baur X, Chen Z, Rozynek P, Düser D, Raulf Heimsoth M. Cross reacting IgE antibodies recognizing latex allergens, including Hev b 1, as well as papain. Allergy 1995; 50(7):604 609.
  9. Furlow TG, Brennan LV. Purpura following timber rattlesnake (Crotalus horridus horridus) envenomation. Cutis 1985; 35:234 236.
  10. Budzynski AZ, Pandya BV, Rubin RN, Brizuela BS, Soszka T, Stewart GJ. Fibrinogenolytic afibrinogenemia after envenomation by western diamondback rattlesnake (Crotalus atrox). Blood 1984; 63(1):1 14.
  11. Kojis FG. Serum sickness and anaphylaxis. Am J Dis Child 1997;93 350.
  12. Kirkpatrick CH, The Digibind Study Advisory Panel. Allergic histories and reactions of patients treated with digoxin immune Fab (ovine) antibody. Am J Emerg Med 1991; 9(2 Suppl 1):7 10.
  13. Lavonas EJ, Khatri V, Daugherty C, Bucher-Bartelson B, King T, Dart RC. Medically significant late bleeding after treated Crotaline envenomation: A systematic review. Ann Emerg Med 2014;63(1):71-78.
  14. Pizon AF, Riley BD, LoVecchio F, and Gill R. Safety and Efficacy of Crotalidae Polyvalent Immune Fab in Pediatric Crotaline Envenomations. Acad Emerg Med 2007;14:373-376.
  15. Offerman SR, Bush SP, Moynihan JA, Clark RF. Crotaline Fab Antivenom for the Treatment of Children with Rattlesnake Envenomation. Pediatrics 2002; 110(5):968-971.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

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.

17 PATIENT COUNSELING INFORMATION

  • 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.

Manufactured for

and distributed by:

BTG International Inc.

West Conshohocken, PA 19428

U.S. License No. 1861

CroFab® is a registered trademark of BTG International Inc.

P11012F

PRINCIPAL DISPLAY PANEL — NDC 50633-110-11 — Vial Label

Vial-Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — NDC 50633-110-12 — Carton Label

Carton-Label
(click image for full-size original)

CROFAB ovine crotalidae venoms immune fab injection, powder, lyophilized, for solution
Product Information
Product Type Item Code (Source) NDC:50633-110
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE) (CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE)) CROTALUS ATROX IMMUNE FAB ANTIVENIN (OVINE) 1 g
AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE) (AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE)) AGKISTRODON PISCIVORUS IMMUNE FAB ANTIVENIN (OVINE) 1 g
CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE) (CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE)) CROTALUS SCUTULATUS IMMUNE FAB ANTIVENIN (OVINE) 1 g
CROTALUS ADAMANTEUS IMMUNE FAB ANTIVENIN (OVINE) (CROTALUS ADAMANTEUS IMMUNE FAB ANTIVENIN (OVINE)) CROTALUS ADAMANTEUS IMMUNE FAB ANTIVENIN (OVINE) 1 g
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50633-110-12 2 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (50633-110-11)
1 NDC:50633-110-11 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS This package is contained within the CARTON (50633-110-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103788 02/10/2000
Labeler — BTG International Inc. (617382395)
Establishment
Name Address ID/FEI Operations
Cangene BioPharma, LLC 050783398 MANUFACTURE (50633-110)
Establishment
Name Address ID/FEI Operations
Protherics UK Limited 536591589 ANALYSIS (50633-110), API MANUFACTURE (50633-110)

Revised: 11/2022 BTG International Inc.

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