HYPERRAB S/D SOLUTION

Երկիր: Կանադա

Լեզու: անգլերեն

Աղբյուրը: Health Canada

Ակտիվ բաղադրիչ:

RABIES IMMUNOGLOBULIN (HUMAN)

Հասանելի է:

GRIFOLS THERAPEUTICS LLC

ATC կոդը:

J06BB05

INN (Միջազգային անվանումը):

RABIES IMMUNOGLOBULIN

Դոզան:

150UNIT

Դեղագործական ձեւ:

SOLUTION

Կազմը:

RABIES IMMUNOGLOBULIN (HUMAN) 150UNIT

Կառավարման երթուղին:

INTRAMUSCULAR

Միավորները փաթեթում:

2ML/10ML

Ռեկվիզորի տեսակը:

Schedule D

Թերապեւտիկ տարածք:

SERUMS

Ապրանքի ամփոփագիր:

Active ingredient group (AIG) number: 0110666002; AHFS:

Լիազորման կարգավիճակը:

CANCELLED POST MARKET

Հաստատման ամսաթիվը:

2022-07-08

Ապրանքի հատկությունները

PRODUCT MONOGRAPH
RABIES IMMUNE GLOBULIN [HUMAN]
HYPERRAB® S/D
_SOLVENT / DETERGENT TREATED_
2 ML AND 10 ML VIALS
INJECTABLE SOLUTION
MANUFACTURER’S STANDARD
THERAPEUTIC CLASSIFICATION
PASSIVE IMMUNIZING AGENT
Manufactured by:
Grifols Therapeutics Inc.
8360 US 70 Bus. Hwy West
Clayton, NC 27520 U.S.A.
Distributed and imported by:
Grifols Canada Ltd.
5060 Spectrum Way, Suite 405
Mississauga, Ontario
L4W 5N5
Control No.: 152140
Date of Approval: January 30, 2012
2
PRODUCT MONOGRAPH
HYPERRAB® S/D
RABIES IMMUNE GLOBULIN [HUMAN]
_SOLVENT/DETERGENT TREATED_
THERAPEUTIC CLASSIFICATION
PASSIVE IMMUNIZING AGENT
INJECTABLE SOLUTION
MANUFACTURER’S STANDARD
ACTION AND CLINICAL PHARMACOLOGY
The usefulness of prophylactic rabies antibody in preventing rabies in
humans when administered
immediately after exposure was dramatically demonstrated in a group of
persons bitten by a rabid
wolf in Iran.
1,2
Similarly, beneficial results were later reported from the U.S.S.R.
3
Studies
coordinated by WHO helped determine the optimal conditions under which
antirabies serum of
equine origin and rabies vaccine can be used in man.
4-7
These studies showed that serum can
interfere to a variable extent with the active immunity induced by the
vaccine, but could be
minimized by booster doses of vaccine after the end of the usual
dosage series.
Preparation of rabies immune globulin of human origin with adequate
potency was reported by
Cabasso et al.
8
In carefully controlled clinical studies, this globulin was used in
conjunction with
rabies vaccine of duck-embryo origin (DEV).
8,9
These studies determined that a human globulin
dose of 20 IU/kg of rabies antibody, given simultaneously with the
first DEV dose, resulted in amply
detectable levels of passive rabies antibody 24 hours after injection
in all recipients. The injections
produced minimal, if any, interference with the subject’s endogenous
antibody response to DEV.
More recently, human diploid cell rabies vaccines (HDCV) prepared from
tissue culture fluids
containing rabies virus h