Source: FDA, National Drug Code (US) Revision Year: 2020
ANAVIP [crotalidae immune F(ab')2 (equine)] is a sterile, lyophilized, polyvalent preparation of equine immunoglobulin F(ab')2 fragments, manufactured from plasma of horses immunized with venom of Bothrops asper and Crotalus durissus. The product is obtained by pepsin digestion of horse plasma to remove the Fc portion of immunoglobulin, followed by fractionation and purification steps. The F(ab')2 content is not less than 85%, F(ab') content is not more than 7%, and the product contains less than 5% intact immunoglobulin. Each vial of ANAVIP contains 25.2-56.8 mg of sodium chloride, 18.2 – 85.8 mg of sucrose, and 16.2-51.8 mg of glycine as stabilizers. Trace amounts of pepsin (≤160 ng/vial), cresol (≤0.058 mg/vial), borates (≤1 mg/vial) and sulfates (≤1.7 mg/vial) may be present from the manufacturing process. Each vial contains no more than 120 mg of protein and will be neutralize not less than 780 times the LD50 of Bothrops asper venom and 790 times the LD50 of Crotalus durissus venom in a mouse neutralization assay.
The manufacturing procedures that contribute to the reduction of risk of viral transmission include pepsin digestion, ammonium sulfate precipitation/heat treatment and nanofiltration.
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ANAVIP is supplied as a sterile, lyophilized powder. Each vial contains not more than 120 milligrams (mg) total protein and not less than the indicated number of mouse LD neutralizing units:
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ANAVIP is supplied as a sterile lyophilized preparation in a single-use 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 780 times the LD50 of Bothrops asper venom and 790 times the LD50 of Crotalus durissus venom in a mouse neutralization assay. Each carton NDC 66621-0790-2 contains 1 vial of ANAVIP NDC 66621-0790-1. Manufactured by: Laboratorios Silanes S.A. de C.V., Toluca, Estado de Mexico, Mexico Manufactured for: Rare Disease Therapeutics, Inc., 2550 Meridian Blvd., Suite 150, Franklin, TN 37067 |
| Drug | Countries | |
|---|---|---|
| ANAVIP | United States |
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