GAMIMUNE N 10% (IV) SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

IMMUNOGLOBULIN (HUMAN)

Dostępny od:

TALECRIS BIOTHERAPEUTICS INC

Kod ATC:

J06BA02

INN (International Nazwa):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Dawkowanie:

100MG

Forma farmaceutyczna:

SOLUTION

Skład:

IMMUNOGLOBULIN (HUMAN) 100MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

10/25/50/100/200ML

Typ recepty:

Schedule D

Dziedzina terapeutyczna:

SERUMS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0106267005; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2006-08-03

Charakterystyka produktu

PRODUCT MONOGRAPH
GAMIMUNE
®
N, 5%
IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5%
(IN 10% MALTOSE) pH 4.25
_Solvent/Detergent Treated_
10, 20, 50, 100, 250 and 500 mL
GAMIMUNE
®
N, 10%
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 27250 U.S.A.
Distributed and imported by:
Date of Approval:
Bayer Inc.
June 1, 2005
77 Belfield Road
Toronto, Ontario
M9W 1G6 CANADA
Control No. 098990
2
PRODUCT MONOGRAPH
GAMIMUNE
®
N, 5%
IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5%
(IN 10% MALTOSE) pH 4.25
_Solvent/Detergent Treated_
10, 20, 50, 100, 250 and 500 mL
GAMIMUNE
®
N, 10%
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% - GAMIMUNE
®
N, 5% and Immune
Globulin Intravenous (Human), 10% - GAMIMUNE
®
N, 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 GAMIMUNE
®
N, 5% and 10% are administered intravenously, essentially
100% of the infused IgG antibodies are immediately available in the
recipient's
3
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% - GAMIMUNE
®
N, 5%
equals or exceeds the three week half-life reported for IgG in the
literature, but
individual patient variation in half-lif