11.07.2015 Views

Infusion Master - NHIA

Infusion Master - NHIA

Infusion Master - NHIA

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octagam ®Immune Globulin Intravenous (Human) 5%Solvent/Detergent TreatedBrief SummaryPlease consult Package Insert for full prescribing informationoctagam ® is indicated for the treatment of primary immunedeficient diseases, such as: congenital agammaglobulinemiaand hypogammaglobulinemia, common variable immunodeficiency,Wiskott-Aldrich syndrome and severe combinedimmunodeficiencies.CONTRAINDICATIONSIntolerance to homologous immunoglobulins, especially invery rare cases of immunoglobulin A (IgA) deficiency, whenthe patient has IgE mediated antibodies to IgA.WARNINGSImmune Globulin intravenous (Human) (IGIV) productshave been reported to be associated with renal dysfunction,acute renal failure, osmotic nephrosis, anddeath. Patients predisposed to acute renal failureinclude patients with any degree of pre-existing renalinsufficiency, diabetes mellitus, age greater than 65,volume depletion, sepsis, paraproteinemia, or patientsreceiving known nephrotoxic drugs. Especially in suchpatients IGIV products should be administered at theminimum concentration available and the minimumrate of infusion practicable. While these reports ofrenal dysfunction and acute renal failure have beenassociated with the use of many of the licensed IGIVproducts, those containing sucrose as stabilizeraccounted for a disproportionate share of the totalnumber.octagam ® does not contain sucrose.See PRECAUTIONS and DOSAGE AND ADMINISTRA-TION sections for important information intended toreduce the risk of acute renal failure.octagam ® , should only be administered intravenously. Otherroutes of administration have not been evaluated.octagam ® should be given at the infusion rate under DOSAGEAND ADMINISTRATION at least until the physician has hadadequate experience with a given patient.Immediate anaphylactic and hypersensitivity reactions are arare possibility. Epinephrine should be available for treatmentof any acute anaphylactoid reactions.octagam ® contains only trace amounts of IgA (

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