IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5% SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

IMMUNOGLOBULIN (HUMAN)

Διαθέσιμο από:

TALECRIS BIOTHERAPEUTICS INC

Φαρμακολογική κατηγορία (ATC):

J06BA02

INN (Διεθνής Όνομα):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Δοσολογία:

5G

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

IMMUNOGLOBULIN (HUMAN) 5G

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

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

Τρόπος διάθεσης:

Schedule D

Θεραπευτική περιοχή:

SERUMS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2006-08-03

Αρχείο Π.Χ.Π.

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