Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)
Baxter Healthcare Corporation
HUMAN IMMUNOGLOBULIN G
HUMAN IMMUNOGLOBULIN G 50 mg in 1 mL
Biologic Licensing Application
GAMMAGARD S/D- HUMAN IMMUNOGLOBULIN G BAXTER HEALTHCARE CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GAMMAGARD S/D SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GAMMAGARD S/D GAMMAGARD S/D, IMMUNE GLOBULIN INTRAVENOUS (HUMAN) SOLVENT DETERGENT TREATED IGA LESS THAN OR EQUAL TO 2.2 ΜG/ML IN A 5% SOLUTION INITIAL U.S. APPROVAL: 1994 WARNING _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROPATHY, AND DEATH MAY OCCUR WITH THE INTRAVENOUS ADMINISTRATION OF HUMAN IMMUNE GLOBULIN PRODUCTS, PARTICULARLY THOSE PRODUCTS THAT CONTAIN SUCROSE. GAMMAGARD S/D DOES NOT CONTAIN SUCROSE. FOR PATIENTS AT RISK OF RENAL DYSFUNCTION OR FAILURE, ADMINISTER GAMMAGARD S/DAT THE MINIMUM RATE OF INFUSION PRACTICABLE. INDICATIONS AND USAGE GAMMAGARD S/D is an Immune Globulin Intravenous (Human), indicated for: Treatment of Primary Immunodeficiency (PI) in adults and pediatric patients two years of age or older. (1.1) Prevention of bacterial infections in hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia (CLL). (1.2) Prevention and/or control of bleeding in adult Chronic Idiopathic Thrombocytopenic Purpura (ITP) patients. (1.3) Prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients. (1.4) DOSAGE AND ADMINISTRATION INTRAVENOUS USE ONLY * INDIC ATIO N RECOMMENDED DOSAGE DURATIO N PI (2.1) 300-600 mg/kg Every 3 to 4 weeks CLL (2.2) 400 mg/kg Every 3 to 4 weeks ITP (2.3) 1g/kg Maximal 3 doses on alternate days Kawasaki Syndrome (2.4) Single 1g/kg or 400 mg/kg for 4 consecutive days Begin within 7 days of onset of fever DOSAGE FORMS AND STRENGTHS Freeze-dried preparation containing 2.5g, 5 g and 10g IgG. (3) CONTRAINDICATIONS History of anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human). (4) IgA-deficient patients with antibodies against IgA and a Izlasiet visu dokumentu