HYPERRAB SD

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

RABIES IMMUNOGLOBULIN

Tilgængelig fra:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC-kode:

J06BB05

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

RABIES IMMUNOGLOBULIN 150 IU/ML

Indgivelsesvej:

I.M

Recept type:

Required

Fremstillet af:

GRIFOLS THERAPEUTICS LLC., USA

Terapeutisk gruppe:

RABIES IMMUNOGLOBULIN

Terapeutisk område:

RABIES IMMUNOGLOBULIN

Terapeutiske indikationer:

To be given in conjunction with Rabies vaccine as promptly as possible after exposure.

Autorisation dato:

2014-10-31

Produktets egenskaber

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