Generic Name and Formulations:
Crotalidae polyvalent immune Fab (Ovine) up to 1g of total protein; per vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Indications for CROFAB:
Management of patients with North American crotalid (eg, rattlesnakes, copperheads, cottonmouths/water moccasins) envenomation.
Adults and Children:
Administer as soon as possible after snakebite at first signs of envenomation (within 6hrs of bite). Give by IV infusion over 60mins. First 10mins, proceed slowly at 25–50mL/hr rate; monitor for any allergic reaction. If no reaction occurs, increase to 250mL/hr rate until complete. Initially: 4–6 vials. Observe up to 1hr after completion of 1st dose; if no response, repeat additional dose of 4–6 vials until initial control achieved. After initially controlled, give additional 2-vial doses every 6hrs up to 18hrs (3 doses). May give additional 2-vial doses if necessary based on patient's clinical course.
History of papaya or papain allergy.
Coagulation defects (eg, cancer, collagen disease, CHF, diarrhea, elevated body temp, hepatic disorders, hyperthyroidism, poor nutritional state, steatorrhea, Vit. K deficiency). Monitor for signs/symptoms of recurrent coagulopathy for ≥1week; reevaluate for retreatment and consider using an anticoagulant or antiplatelet drug. Allergies to papain, chymopapain, papaya extracts, pineapple enzyme (bromelain), dust mites or latex allergens. Risk of anaphylactic reaction (esp. if allergic to sheep protein). Monitor for signs/symptoms of allergic reaction; discontinue if occurs. Have epinephrine, antihistamine and/or albuterol available. Pregnancy. Nursing mothers.
Antivenin (monovalent immunoglobulin G [IgG] fragments).
Urticaria, rash, pruritus, nausea, back pain; coagulation abnormalities, acute and delayed hypersensitivity reactions (may be severe), serum sickness.
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