HYPERRAB SD

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

RABIES IMMUNOGLOBULIN

から入手可能:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATCコード:

J06BB05

医薬品形態:

SOLUTION FOR INJECTION

構図:

RABIES IMMUNOGLOBULIN 150 IU/ML

投与経路:

I.M

処方タイプ:

Required

製:

GRIFOLS THERAPEUTICS LLC., USA

治療群:

RABIES IMMUNOGLOBULIN

治療領域:

RABIES IMMUNOGLOBULIN

適応症:

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

承認日:

2014-10-31

製品の特徴

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