Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
RABIES IMMUNOGLOBULIN (HUMAN)
GRIFOLS THERAPEUTICS LLC
J06BB05
RABIES IMMUNOGLOBULIN
150UNIT
SOLUTION
RABIES IMMUNOGLOBULIN (HUMAN) 150UNIT
INTRAMUSCULAR
2ML/10ML
Schedule D
SERUMS
Active ingredient group (AIG) number: 0110666002; AHFS:
CANCELLED POST MARKET
2022-07-08
PRODUCT MONOGRAPH RABIES IMMUNE GLOBULIN [HUMAN] HYPERRAB® S/D _SOLVENT / DETERGENT TREATED_ 2 ML AND 10 ML VIALS INJECTABLE SOLUTION MANUFACTURER’S STANDARD THERAPEUTIC CLASSIFICATION PASSIVE IMMUNIZING AGENT Manufactured by: Grifols Therapeutics Inc. 8360 US 70 Bus. Hwy West Clayton, NC 27520 U.S.A. Distributed and imported by: Grifols Canada Ltd. 5060 Spectrum Way, Suite 405 Mississauga, Ontario L4W 5N5 Control No.: 152140 Date of Approval: January 30, 2012 2 PRODUCT MONOGRAPH HYPERRAB® S/D RABIES IMMUNE GLOBULIN [HUMAN] _SOLVENT/DETERGENT TREATED_ THERAPEUTIC CLASSIFICATION PASSIVE IMMUNIZING AGENT INJECTABLE SOLUTION MANUFACTURER’S STANDARD ACTION AND CLINICAL PHARMACOLOGY The usefulness of prophylactic rabies antibody in preventing rabies in humans when administered immediately after exposure was dramatically demonstrated in a group of persons bitten by a rabid wolf in Iran. 1,2 Similarly, beneficial results were later reported from the U.S.S.R. 3 Studies coordinated by WHO helped determine the optimal conditions under which antirabies serum of equine origin and rabies vaccine can be used in man. 4-7 These studies showed that serum can interfere to a variable extent with the active immunity induced by the vaccine, but could be minimized by booster doses of vaccine after the end of the usual dosage series. Preparation of rabies immune globulin of human origin with adequate potency was reported by Cabasso et al. 8 In carefully controlled clinical studies, this globulin was used in conjunction with rabies vaccine of duck-embryo origin (DEV). 8,9 These studies determined that a human globulin dose of 20 IU/kg of rabies antibody, given simultaneously with the first DEV dose, resulted in amply detectable levels of passive rabies antibody 24 hours after injection in all recipients. The injections produced minimal, if any, interference with the subject’s endogenous antibody response to DEV. More recently, human diploid cell rabies vaccines (HDCV) prepared from tissue culture fluids containing rabies virus h Soma hati kamili