Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
RABIES IMMUNOGLOBULIN
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
J06BB05
SOLUTION FOR INJECTION
RABIES IMMUNOGLOBULIN 150 IU/ML
I.M
Required
GRIFOLS THERAPEUTICS LLC., USA
RABIES IMMUNOGLOBULIN
RABIES IMMUNOGLOBULIN
To be given in conjunction with Rabies vaccine as promptly as possible after exposure.
2014-10-31
THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH AND ITS CONTENT WAS CHECKED AND APPROVED IN DECEMBER 2011 PRESCRIBING INFORMATION HYPERRAB ® S/D RABIES IMMUNE GLOBULIN (HUMAN) SOLVENT/DETERGENT TREATED DESCRIPTION Rabies Immune Globulin (Human),-HyperRAB ® S/D treated with solvent/detergent is a colorless to pale yellow or pink sterile solution of antirabies immune globulin for intramuscular administration; it is preservative-free and latex-free. HyperRAB S/D is prepared by cold ethanol fractionation from the plasma of donors hyperimmunized with rabies vaccine. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30 o C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. HyperRAB S/D is formulated as a 15%-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. HyperRAB S/D is then incubated in a final container for 21-28 days at 20-27 o C. The product is standardized against the U.S. Standard Rabies Immune Globulin to contain an average potency value of 150 IU/mL. The U.S. unit of potency is equivalent to the International Unit (IU) for rabies antibody. The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperRAB S/D has been validated in laboratory studies. Human Immunodeficiency Virus, Type 1(HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical Lugege kogu dokumenti