HYPERRAB S/D (rabies immune globulin- human injection

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Human Rabies Virus Immune Globulin (UNII: 95F619ATQ2) (Human Rabies Virus Immune Globulin - UNII:95F619ATQ2)

Tilgængelig fra:

GRIFOLS USA, LLC

INN (International Name):

Human Rabies Virus Immune Globulin

Sammensætning:

Human Rabies Virus Immune Globulin 150 [iU] in 1 mL

Indgivelsesvej:

INTRAMUSCULAR

Terapeutiske indikationer:

Rabies vaccine and HyperRAB S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. HyperRAB S/D should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given. Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S. Public Health Service Advisory Committee on Immunization Practices (ACIP). [19] Every exposure to possible rabies infection must be individually evaluated. The following factors should be considered before specific antirabies treatment is initiated: Carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies

Produkt oversigt:

HyperRAB S/D is packaged in 2 mL and 10 mL single dose vials with an average potency value of 150 international units per mL (IU/mL). The 2 mL vial contains a total of 300 IU which is sufficient for a child weighing 15 kg. The 10 mL vial contains a total of 1500 IU which is sufficient for an adult weighing 75 kg. HyperRAB S/D is preservative-free and latex-free.

Autorisation status:

Biologic Licensing Application

Produktets egenskaber

HYPERRAB S/D- RABIES IMMUNE GLOBULIN (HUMAN) INJECTION
GRIFOLS USA, LLC
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RABIES IMMUNE GLOBULIN (HUMAN)
HYPERRAB S/D
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°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 the final container for 21–28 days
at 20–27°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 inactivation.
Significant removal of model enveloped and non