IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5% SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

IMMUNOGLOBULIN (HUMAN)

Fáanlegur frá:

TALECRIS BIOTHERAPEUTICS INC

ATC númer:

J06BA02

INN (Alþjóðlegt nafn):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Skammtar:

5G

Lyfjaform:

SOLUTION

Samsetning:

IMMUNOGLOBULIN (HUMAN) 5G

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

10/20/50/100/250/500ML

Gerð lyfseðils:

Schedule D

Lækningarsvæði:

SERUMS

Vörulýsing:

Active ingredient group (AIG) number: 0106267014; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2006-08-03

Vara einkenni

PRODUCT MONOGRAPH
IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5%
(IN 10% MALTOSE) pH 4.25
_Solvent/Detergent Treated_
10, 20, 50, 100, 250 and 500 mL
IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10%
(IN 0.16-0.24 M GLYCINE) pH 4.25
_Solvent/Detergent Treated_
10, 25, 50, 100 and 200 mL
PASSIVE IMMUNIZING AGENT
Manufactured by:
Talecris Biotherapeutics, Inc.
8368 US 70 West
Clayton, NC 27520 U.S.A.
Distributed and imported by:
Bayer Inc.
77 Belfield Road
Etobicoke, Ontario
M9W 1G6 CANADA
Date of Approval:
June 1, 2005
Prepared for:
Canadian Blood Services
Ottawa, Ontario
K1G 4J5 CANADA
Prepared for:
Héma-Québec
Saint-Laurent, Québec
H4R 2W7 CANADA
Control No. 098988
2
PRODUCT MONOGRAPH
IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5%
(IN 10% MALTOSE) pH 4.25
_Solvent/Detergent Treated_
10, 20, 50, 100, 250 and 500 mL
IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10%
(IN 0.16-0.24 M GLYCINE) pH 4.25
_Solvent/Detergent Treated_
10, 25, 50, 100 and 200 mL
THERAPEUTIC CLASSIFICATION
PASSIVE IMMUNIZING AGENT
ACTION AND CLINICAL PHARMACOLOGY
Primary Humoral Immunodeficiency
Immune Globulin Intravenous (Human), 5% and Immune Globulin
Intravenous
(Human), 10% treated with solvent/detergent supply, a broad spectrum
of opsonic
and neutralizing IgG antibodies for the prevention or attenuation of a
wide variety
of infectious diseases. Since Immune Globulin Intravenous (Human), 5%
and 10%
are administered intravenously, essentially 100% of the infused IgG
antibodies are
immediately available in the recipient's circulation.
1
Studies using a modified
immunoglobulin at pH 6.8 have shown that approximately 30% of the
infused IgG
disappeared from the circulation in the first 24 hours due primarily
to equilibration
of IgG between the plasma and the extravascular space.
1-4
A further decline of about
40% of the peak level found immediately post-infusion is to be
expected during the
first week.
1-4
The in vivo half-life of Immune Globulin Intravenous (Human), 5%
3
equals or exceeds the three week half-life reported for IgG in the
literature, but
individual patien