GAMMAGARD S/D (immune globulin intravenous- human kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)

Tilgjengelig fra:

Takeda Pharmaceuticals America, Inc.

INN (International Name):

HUMAN IMMUNOGLOBULIN G

Sammensetning:

HUMAN IMMUNOGLOBULIN G 50 mg in 1 mL

Indikasjoner:

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

Produkt oppsummering:

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.

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

GAMMAGARD S/D- IMMUNE GLOBULIN INTRAVENOUS (HUMAN)
TAKEDA PHARMACEUTICALS AMERICA, INC.
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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