HYPERRHO S/D FULL DOSE SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ANTI-D (RH) IMMUNOGLOBULIN (HUMAN)

Disponible depuis:

GRIFOLS THERAPEUTICS LLC

Code ATC:

J06BA01

DCI (Dénomination commune internationale):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASC. ADM

Dosage:

1500UNIT

forme pharmaceutique:

SOLUTION

Composition:

ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 1500UNIT

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

3ML

Type d'ordonnance:

Schedule D

Domaine thérapeutique:

SERUMS

Descriptif du produit:

Active ingredient group (AIG) number: 0106269004; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2022-07-08

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
HYPERRHO™ S/D FULL DOSE
Rh
o
(D) Immune Globulin [Human]
Bayer Standard
_Solvent / Detergent Treated_
Solution for Injection
Single use vials and pre-filled syringes
Passive Immunizing Agent
Manufactured by:
Talecris Biotherapeutics, Inc.
8368 US 70 West
Clayton, NC 27520 U.S.A.
Distributed and imported by:
Bayer Inc.
Date of Approval:
77 Belfield Road
June 1, 2005
Toronto, Ontario
M9W 1G6 Canada
Control No. 098984
2
PRODUCT MONOGRAPH
HYPERRHO™ S/D FULL DOSE
Rh
o
(D) Immune Globulin [Human]
Bayer Standard
_Solvent/Detergent Treated_
Solution for Injection
THERAPEUTIC CLASSIFICATION
Passive Immunizing Agent
ACTION AND CLINICAL PHARMACOLOGY
HYPERRHO™ S/D FULL DOSE (Rh
o
(D) Immune Globulin [Human]) is used to
prevent isoimmunization in the Rh
o
(D) negative individual exposed to Rh
o
(D)
positive blood as a result of a fetomaternal hemorrhage occurring
during a delivery
of an Rh
o
(D) positive infant, abortion (either spontaneous or induced), or
following
amniocentesis or abdominal trauma. Similarly, immunization resulting
in the
production of anti-Rh
o
(D) following transfusion of Rh positive red cells to an Rh
o
(D)
negative recipient may be prevented by administering Rh
o
(D) Immune Globulin
[Human].
1,2
Rh hemolytic disease of the newborn is the result of the active
immunization of an
Rh
o
(D) negative mother by Rh
o
(D) positive red cells entering the maternal circulation
during a previous delivery, abortion, amniocentesis, abdominal trauma,
or as a result
of red cell transfusion.
3,4
HYPERRHO™ S/D FULL DOSE (Rh
o
(D) Immune
Globulin [Human]) acts by suppressing the immune response of Rh
o
(D) negative
individuals to Rh
o
(D) positive red blood cells. The mechanism of action of
HYPERRHO™ S/D FULL DOSE (Rh
o
(D) Immune Globulin [Human]) is not fully
understood.
3
The administration of Rh
o
(D) Immune Globulin [Human] within 72 hours of a full-
term delivery of an Rh
o
(D) positive infant by an Rh
o
(D) negative mother reduces the
incidence of Rh isoimmunization from 12%–13% to 1%�