IMOGAM RABIES-HT- human rabies virus immune globulin injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

HUMAN RABIES VIRUS IMMUNE GLOBULIN (UNII: 95F619ATQ2) (HUMAN RABIES VIRUS IMMUNE GLOBULIN - UNII:95F619ATQ2)

Dostupno od:

Sanofi Pasteur Inc.

INN (International ime):

HUMAN RABIES VIRUS IMMUNE GLOBULIN

Sastav:

HUMAN RABIES VIRUS IMMUNE GLOBULIN 150 [iU] in 1 mL

Administracija rute:

INTRAMUSCULAR

Terapijske indikacije:

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

Proizvod sažetak:

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.

Status autorizacije:

Biologic Licensing Application

Svojstava lijeka

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