Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)
Bio Products Laboratory Limited
INTRAVENOUS
GAMMAPLEX 5% is an Immune Globulin Intravenous (Human), 5% Liquid indicated for replacement therapy in primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older. This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency, X-linked agammaglobulinemia (XLA), congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. GAMMAPLEX 5% is indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to raise platelet counts. - GAMMAPLEX 5% is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. - GAMMAPLEX 5% is contraindicated in patients with hereditary intolerance to fructose, also in infants and neonates for whom sucrose or fructose tolerance has not been established. - GAMMAPLEX 5% is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Risk Summary A
GAMMAPLEX 5% is supplied in a single use, clear Type II glass bottle, closed with a stopper and oversealed with a tamper-evident cap. The components used in the packaging for GAMMAPLEX 5% are not made with natural rubber latex. The following presentations of GAMMAPLEX 5% are available: Each vial has a label with a peel-off strip showing the product name and batch number. When stored between 2 °C [35.6 °F] and 25 °C [77 °F], GAMMAPLEX 5% has a shelf-life of 36 months. Keep GAMMAPLEX 5% in its original carton to protect it from light. Do not freeze.
Biologic Licensing Application
GAMMAPLEX- HUMAN IMMUNOGLOBULIN G SOLUTION BIO PRODUCTS LABORATORY LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GAMMAPLEX 5% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GAMMAPLEX 5% . GAMMAPLEX 5% IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 5% LIQUID, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2009 WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN PRODUCTS, INCLUDING GAMMAPLEX 5%. 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 (5.2). RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS, AND DEATH MAY OCCUR IN PREDISPOSED PATIENTS WITH IMMUNE GLOBULIN INTRAVENOUS (LGIV) PRODUCTS, INCLUDING GAMMAPLEX 5%. RENAL DYSFUNCTION AND ACUTE RENAL FAILURE OCCUR MORE COMMONLY WITH IGIV PRODUCTS CONTAINING SUCROSE. GAMMAPLEX 5% DOES NOT CONTAIN SUCROSE (5.1). FOR PATIENTS AT RISK OF THROMBOSIS, RENAL DYSFUNCTION OR ACUTE RENAL FAILURE, ADMINISTER GAMMAPLEX 5% 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 FOR HYPERVISCOSITY (2.3, 5.1). INDICATIONS AND USAGE GAMMAPLEX 5% is an Immune Globulin Intravenous (Human) 5% Liquid indicated for the treatment of: primary humoral immunodeficiency (PI) in adults and pediatric patients 2 years of age and older (1.1) chronic immune thrombocytopenic purpura (ITP) (1.2) DOSAGE AND ADMINISTRATION FOR INTRAVENOUS USE ONLY INDICATION DOSE INITIAL INFUSION RATE MAINTENANCE INFUSION RATE (IF TOLERATED) PI 300-800 mg/kg (6-16 mL/kg) every 3-4 weeks 0.5 mg/kg/min (0.01 mL/kg/min) for 15 minutes Increase gradually every 15 minutes to 4 mg/kg/min (0.08 mL/kg/m Citiți documentul complet