מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
HUMAN RABIES VIRUS IMMUNE GLOBULIN (UNII: 95F619ATQ2) (HUMAN RABIES VIRUS IMMUNE GLOBULIN - UNII:95F619ATQ2)
Sanofi Pasteur Inc.
HUMAN RABIES VIRUS IMMUNE GLOBULIN
HUMAN RABIES VIRUS IMMUNE GLOBULIN 150 [iU] in 1 mL
INTRAMUSCULAR
Rabies Immune Globulin (Human) Heat Treated, Imogam Rabies – HT, in conjunction with the standard series of Rabies Vaccine vaccinations, is indicated for individuals suspected of exposure to rabies, particularly severe exposure, with one exception: persons who have been previously immunized with Rabies Vaccine. Previously immunized persons are those who have had a documented rabies virus neutralizing antibody titer and who have completed one of the recommended regimens (pre-exposure or post-exposure) with a cell culture vaccine or another vaccine. Administer only vaccine to these persons (i.e., post-exposure for a person previously vaccinated). (1) Inject Imogam Rabies – HT, as promptly as possible after exposure, along with the first dose of vaccine. If initiation of treatment is delayed for any reason, still administer Imogam Rabies – HT and the first dose of vaccine, regardless of the interval between exposure and treatment. If Rabies Immune Globulin (Human) was not administered when vaccination was begun
Imogam Rabies – HT is supplied in a 2 mL single-dose vial with a minimal potency of 150 International Units per milliliter (IU/mL). Multiple vials may be needed for a single effective dose. Single-dose vial, 2 mL, NDC 49281-190-58. Packaged as NDC 49281-190-20. Imogam Rabies – HT contains no preservative. Discard unused portion immediately.
Biologic Licensing Application
IMOGAM RABIES-HT- HUMAN RABIES VIRUS IMMUNE GLOBULIN INJECTION, SOLUTION SANOFI PASTEUR INC. ---------- RABIES IMMUNE GLOBULIN (HUMAN) USP, HEAT TREATED IMOGAM RABIES – HT AHFS Category: 80:04 RIG _RX ONLY_ FOR WOUND INFILTRATION AND INTRAMUSCULAR USE ONLY DESCRIPTION Rabies Immune Globulin (Human) USP, Heat Treated, Imogam Rabies – HT, is a sterile solution of antirabies immunoglobulin (10-16% protein) for wound infiltration and intramuscular administration. Rabies immune globulin (RIG) is prepared by cold alcohol fractionation from pooled venous plasma of individuals immunized with Rabies Vaccine prepared from human diploid cells (HDCV). The product is stabilized with 0.3 M glycine. The immune globulin solution has a pH of 6.8 ± 0.4 adjusted with sodium hydroxide or hydrochloric acid. No preservatives are added. Imogam Rabies – HT is a clear or slightly opalescent, colorless or pale-yellow or light-brown liquid. During storage it may show formation of slight turbidity or a small amount of visible particulate matter. A heat-treatment process step (58° to 60°C, 10 hours) to inactivate viruses is used to further reduce any risk of blood-borne viral transmission. The inactivation and removal of model laboratory strains of enveloped and non-enveloped viruses during the manufacturing and heat treatment processes for Imogam Rabies – HT have been validated by spiking experiments. Human immunodeficiency virus, type 1 (HIV-1) and type 2 (HIV-2) were selected as relevant viruses for plasma derived products. Bovine viral diarrhea virus and Sindbis virus were chosen to model hepatitis C virus. Porcine pseudorabies virus was selected to model hepatitis B virus and herpes virus. Avian reovirus was used to model non-enveloped RNA viruses and for its relative resistance to inactivation by chemical and physical methods. Finally, porcine parvovirus was selected to model human parvovirus B19 and its notable resistance to inactivation by heat treatment. Removal and/or inactivation of the spiked model viruses was demonstr קרא את המסמך השלם