Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)
Octapharma USA Inc
HUMAN IMMUNOGLOBULIN G
HUMAN IMMUNOGLOBULIN G 50 mg in 1 mL
Intravenous
Octagam is an immune globulin intravenous (human) 5% liquid indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. Octagam 5% liquid is contraindicated - in patients who have acute severe hypersensitivity reactions to human immunoglobulin. - in IgA deficient patients with antibodies against IgA and history of hypersensitivity. Octagam 5% liquid contains trace amounts of IgA (not more than 0.2 mg/mL in a 5% solution). (See Description [ 11 ]) - in patients with acute hypersensitivity reaction to corn. Octagam 5% liquid contains maltose, a disaccharide sugar that is derived from corn. Patients known to have corn allergies should avoid using Octagam 5% liquid. Risk Summary No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with Octagam 5% liquid
Octagam 5% liquid is supplied in 1.0 g, 2.5 g, 5 g, 10 g or 25 g single use bottles.
Biologic Licensing Application
OCTAGAM IMMUNE GLOBULIN (HUMAN)- IMMUNE GLOBULIN SOLUTION OCTAPHARMA USA INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OCTAGAM, IMMUNE GLOBULIN INTRAVENOUS (HUMAN), SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OCTAGAM. OCTAGAM [IMMUNE GLOBULIN INTRAVENOUS (HUMAN)] 5% LIQUID PREPARATION INITIAL U.S. APPROVAL: 2004 WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN INTRAVENOUS (IGIV) PRODUCTS, INCLUDING OCTAGAM 5% LIQUID. 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. RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROSIS, AND DEATH MAY OCCUR IN PREDISPOSED PATIENTS WITH IGIV PRODUCTS, INCLUDING OCTAGAM 5% LIQUID. RENAL DYSFUNCTION AND ACUTE RENAL FAILURE OCCUR MORE COMMONLY WITH IGIV PRODUCTS CONTAINING SUCROSE. OCTAGAM 5% LIQUID DOES NOT CONTAIN SUCROSE. FOR PATIENTS AT RISK OF THROMBOSIS, RENAL DYSFUNCTION OR ACUTE RENAL FAILURE ADMINISTER OCTAGAM 5% LIQUID 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. INDICATIONS AND USAGE Octagam is an immune globulin intravenous (human), 5% liquid, indicated for treatment of primary humoral immunodeficiency (PI) ( 1 ). DOSAGE AND ADMINISTRATION INTRAVENOUS USE ONLY ( 2 ). Indication Dose Initial Infusion rate Maintenance infusion rate (if tolerated) PI 300-600 mg/kgEvery 3-4 weeks 0.5 mg/kg/min 3.33 mg/kg/min • Ensure that patients with pre-existing renal insufficiency are not volume depleted; discontinue Octagam 5% liquid if renal function deteriorates ( 2.3 ). • For patients at risk of renal dysfunction or Lestu allt skjalið