Source: FDA, National Drug Code (US) Revision Year: 2020
ANASCORP [centruroides (scorpion) immune F(ab')2 (equine) injection] is a sterile nonpyrogenic, lyophilized, polyvalent preparation of equine immune globulin F(ab')2 fragments, manufactured from plasma of horses immunized with with venom of C. noxius, C.l. limpidus, C.l. tecomanus, and C.s.suffusus. The product is obtained by pepsin digestion of horse plasma to remove the Fc portion of immune globulin, 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 ANASCORP contains 45-80 milligrams of sodium chloride, 4.3-38.3 milligrams of sucrose, and 6.6-94.9 milligrams of glycine as stabilizers. Trace amounts of pepsin, 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 19 milligrams of protein and will neutralize at least 150 LD of Centruroides scorpion 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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Each vial of ANASCORP contains a sterile, lyophilized preparation containing not more than 19 milligrams total protein and not less than 150 LD50 (mouse) neutralizing units. |
| How Supplied |
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ANASCORP is supplied as a sterile lyophilized preparation in a single-use vial. When reconstituted, each vial contains not more than 3.8 milligrams per milliliter of protein, and not less than 150 mouse LD neutralizing units. Each carton NDC 66621-0150-2 contains 1 vial of ANASCORP NDC 66621-0150-1. 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 | |
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| ANASCORP | United States |
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