Land: Kanada
Språk: engelska
Källa: Health Canada
IMMUNOGLOBULIN (HUMAN)
TALECRIS BIOTHERAPEUTICS INC
J06BA02
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.
5G
SOLUTION
IMMUNOGLOBULIN (HUMAN) 5G
INTRAVENOUS
10/20/50/100/250/500ML
Schedule D
SERUMS
Active ingredient group (AIG) number: 0106267014; AHFS:
CANCELLED POST MARKET
2006-08-03
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 Läs hela dokumentet