Country: United States
Language: English
Source: NLM (National Library of Medicine)
PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) (UNII: 92VV7G83ED) (PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) - UNII:92VV7G83ED)
Rare Disease Therapeutics, Inc
PIT VIPER IMMUNE GLOBULIN ANTIVENIN IMMUNE GLOBULIN ANTIVENIN - UNII:92VV7G83ED)
PIT VIPER (CROTALINAE) IMMUNE GLOBULIN ANTIVENIN (EQUINE) 24 mg in 1 mL
INTRAVENOUS
ANAVIP [crotalidae immune F(ab')2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American Pit Viper envenomation.
ANAVIP is supplied as a sterile, lyophilized preparation in a single-dose vial. When reconstituted with 10 mL of 0.9% NaCl solution, each vial contains not more than 12 mg per mL of protein, and will neutralize not less than 780 times the LD50 of Bothrops asper (Terciopelo or fer-de-lance) venom and 790 times the LD50 of Crotalus simus (formerly Crotalus durissus) (Central American Rattlesnake) venom, 244 times the LD50 of Crotalus adamanteus (Eastern Diamondback Rattlesnake) venom, 147 times the LD50 of Crotalus atrox (Western Diamondback Rattlesnake) venom, 185 times the LD50 of Crotalus scutulatus (Mohave Rattlesnake) venom, 28 times the LD50 of Agkistrodon contortrix (Copperhead) venom and 61 times the LD50 of Agkistrodon piscivorus (Cottonmouth or Water Moccasin) venom in a mouse neutralization assay. Each carton NDC 66621-0790-2 contains 1 vial of ANAVIP NDC 66621-0790-1.
Biologic Licensing Application
ANAVIP- CROTALIDAE IMMUNE F(AB)2(EQUINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION RARE DISEASE THERAPEUTICS, INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ANAVIP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ANAVIP. ANAVIP CROTALIDAE IMMUNE F(AB') (EQUINE) LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION FOR INTRAVENOUS USE ONLY INITIAL U.S. APPROVAL: 2015 RECENT MAJOR CHANGES Indication and Use (1) April 2021 Dosage and Administration (2) April 2021 Animal Toxicology and/or Pharmacology (13.2) April 2021 INDICATIONS AND USAGE ANAVIP [crotalidae immune F(ab') (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with North American Pit Viper envenomation. (1) DOSAGE AND ADMINISTRATION INTRAVENOUS USE ONLY. DOSE NO. OF VIALS INFUSION RATE Initial Dose 10 vials Infuse intravenously over 60 minutes. Additional dose(s) to achieve initial control 10 vials (as needed) Infuse intravenously over 60 minutes. Observation and late dosing 4 vials Infuse intravenously over 60 minutes. Initiate administration as soon as possible after North American Pit Viper bite in patients who develop signs of envenomation (e.g., local injury, coagulation abnormality, or systemic signs of envenomation). (2) Monitor patients in a health care setting at least 18 hours following initial control of signs and symptoms. Re-emerging symptoms including coagulapathies may be suppressed with an additional 4 vial doses of ANAVIP as needed. (2) Reconstitute each vial with 10 milliliters (mL) of sterile normal saline (0.9% NaCl). (2) Combine and further dilute to a total of 250 mL with sterile normal saline (0.9% NaCl). (2) DOSAGE FORMS AND STRENGTHS Each vial contains a sterile, lyophilized preparation containing not more than 120 milligrams total protein and not less than the indicated number of mouse LD neutralizing units (3): SNAKE SPECIES USED FOR STANDARDIZATION MINIMUM MOUSE LD UNITS PER VIAL _Bothrops asper_ (T Read the complete document