GAMMAGARD S/D human immunoglobulin

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Baxter Healthcare Corporation

INN (International Name):

HUMAN IMMUNOGLOBULIN G

Sammensætning:

HUMAN IMMUNOGLOBULIN G 50 mg in 1 mL

Autorisation status:

Biologic Licensing Application

Produktets egenskaber

GAMMAGARD S/D- HUMAN IMMUNOGLOBULIN G
BAXTER HEALTHCARE CORPORATION
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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)
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