A STERILE NONPYROGENIC, PURIFIED, LYOPHILIZED PREPARATION OF OVINE FAB (MONOVALENT) IMMUNOGLOBULIN FRAGMENTS OBTAINED FROM THE BLOOD OF HEALTHY SHEEP FLOCKS IMMUNIZED WITH ONE OF THE FOLLOWING NORTH AMERICAN SNAKE VENOMS. (WESTERN DIAMONDBACK RATTLESNAKE, EASTERN DIAMONDBACK RATTLESNAKE, MOJAVE RATTLESNAKE OR WATER MOCCASIN). TO OBTAIN THE FINAL ANTIVENIN PRODUCT, THE FOUR DIFFERENT MONOSPECIFIC ANTIVENINS ARE MIXED. EACH MONOSPECIFIC ANTIVENIN IS PREPARED BY FRACTIONATING THE IMMUNOGLOBULIN FROM THE OVINE SERUM, DIGESTING IT WITH PAPAIN AND ISOLATING THE VENOM SPECIFIC FAB FRAGMENTS ON ION EXCHANGE AND AFFINITY CHROMATOGRAPHY COLUMNS. EACH VIAL CONTAINS UP TO 1G OF TOTAL PROTEIN AND NOT LESS THAN THE INDICATED NUMBER OF MOUSE LD50 NEUTRALIZING UNITS PER VIAL. USED FOR THE MANAGEMENT OF PATIENTS WITH NORTH AMERICAN CROTALID ENVENOMATION.

CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING:- GENERAL INTERPRETATIVE RULES (GIRS) GIR 1 HAS BEEN USED TO CLASSIFY THIS PRODUCT BY THE TERMS OF HEADING 3002 - HUMAN BLOOD; ANIMAL BLOOD PREPARED FOR THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS, CULTURES OF MICRO-ORGANISMS (EXCLUDING YEASTS) AND SIMILAR PRODUCTS GIR 5B HAS BEEN USED TO IDENTIFY THE TYPE OF PACKAGING. GIR 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300210 - ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES ALSO CLASSIFIED IN ACCORDANCE WITH: HSENs TO 3002 AND CNENs TO 3002