EACH VIAL CONTAINS 40 MG OF DIGOXIN IMMUNE DIGIFAB IS A STERILE, LYOPHILIZED PREPARATION OF DIGOXIN-IMMUNE OVINE FAB (MONOVALENT) IMMUNOGLOBULIN FRAGMENTS. THESE FRAGMENTS ARE OBTAINED FROM THE BLOOD OF HEALTHY SHEEP IMMUNIZED WITH A DIGOXIN DERIVATIVE, DIGOXIN DICARBOXYMETHOXYLAMINE (DDMA), A DIGOXIN ANALOGUE WHICH CONTAINS THE FUNCTIONALLY ESSENTIAL CYCLOPENTAPERHYDROPHENANTHRENE: LACTONE RING MOIETY COUPLED TO KEYHOLE LIMPET HEMOCYANIN (KLH). THE FINAL PRODUCT IS PREPARED BY ISOLATING THE IMMUNOGLOBULIN FRACTION OF THE OVINE SERUM, DIGESTING IT WITH PAPAIN AND ISOLATING THE DIGOXIN-SPECIFIC FAB FRAGMENTS BY AFFINITY CHROMATOGRAPHY

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 HS Explanatory Notes to heading 3002, (C), (1), third paragraph.