国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)
Takeda Pharmaceuticals America, Inc.
HUMAN IMMUNOGLOBULIN G
HUMAN IMMUNOGLOBULIN G 50 mg in 1 mL
Primary Immunodeficiency (PI) GAMMAGARD S/D is indicated for the treatment of primary immunodeficiency (PI) associated with defects in humoral immunity, in adults and children two years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.1,2,3 B-cell Chronic Lymphocytic Leukemia (CLL) GAMMAGARD S/D is indicated for prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL).4 Idiopathic Thrombocytopenic Purpura (ITP) GAMMAGARD S/D is indicated for the treatment of adult chronic idiopathic thrombocytopenic purpura to increase platelet count and to prevent and/or to control bleeding. Kawasaki Syndrome GAMMAGARD S/D is indicated for the prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients.5 GAMMAGARD S/D is contraindicated in patients wh
GAMMAGARD S/D is supplied in single use bottles containing the labeled amount of functionally active IgG. The following presentation of GAMMAGARD S/D is available: Each bottle of GAMMAGARD S/D is furnished with a suitable volume of Sterile Water for Injection, USP, a transfer device and an administration set which contains an integral airway and a 15 micron filter. Store GAMMAGARD S/D at a temperature not to exceed 25ºC (77ºF) for 24 months. Do not Freeze. Not made with natural rubber latex.
Biologic Licensing Application
GAMMAGARD S/D- IMMUNE GLOBULIN INTRAVENOUS (HUMAN) TAKEDA PHARMACEUTICALS AMERICA, INC. ---------- 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) IGA LESS THAN 1 MICROGRAM PER ML IN A 5% SOLUTION INITIAL U.S. APPROVAL: 1994 WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING GAMMAGARD S/D. RISK FACTORS MAY INCLUDE ADVANCED AGE, PROLONGED IMMOBILIZATION, HYPERCOAGULABLE CONDITIONS, HISTORY OF VENOUS OR ARTERIAL THROMBOSIS, USE OF ESTROGENS, INDWELLING VASCULAR CATHETERS, HYPERVISCOSITY AND CARDIOVASCULAR RISK FACTORS. (5.3) RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS, AND DEATH MAY OCCUR IN PREDISPOSED PATIENTS WITH IMMUNE GLOBULIN INTRAVENOUS (IGIV) PRODUCTS, INCLUDING GAMMAGARD S/D. RENAL DYSFUNCTION AND ACUTE FAILURE OCCUR MORE COMMONLY WITH IGIV PRODUCTS CONTAINING SUCROSE. GAMMAGARD S/D DOES NOT CONTAIN SUCROSE. (5.2) FOR PATIENTS AT RISK OF THROMBOSIS, ADMINISTER GAMMAGARD S/D AT THE MINIMUM DOSE AND INFUSION RATE PRACTICABLE. ENSURE ADEQUATE HYDRATION IN PATIENTS BEFORE ADMINISTRATION. MONITOR FOR SIGNS AND SYMPTOMS OF THROMBOSIS AND ASSESS BLOOD VISCOSITY IN PATIENTS AT RISK OF HYPERVISCOSITY. (5.3) 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) Prevention of bacterial infections in hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL). (1) Prevention and/or control of bleeding in adult chronic idiopathic thrombocytopenic purpura (ITP) patients. (1) Prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients. (1) DOS 完全なドキュメントを読む