Country: Կանադա
language: անգլերեն
source: Health Canada
IMMUNOGLOBULIN (HUMAN)
TALECRIS BIOTHERAPEUTICS INC
J06BA02
IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.
100MG
SOLUTION
IMMUNOGLOBULIN (HUMAN) 100MG
INTRAVENOUS
10/25/50/100/200ML
Schedule D
SERUMS
Active ingredient group (AIG) number: 0106267005; AHFS:
CANCELLED POST MARKET
2006-08-03
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 read_full_document