GAMUNEX SUMMARY
Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, (GAMUNEX®) is a ready-to-use sterile solution of human immune globulin protein for intravenous administration. GAMUNEX® consists of 9%-11% protein in 0.16-0.24 M glycine. Not less than 98% of the protein has the electrophoretic mobility of gamma globulin. GAMUNEX® contains trace levels of fragments and IgA (average 0.046 mg/mL). IgM levels were at or below the limit of quantitation (0.002 g/L). The distribution of IgG subclasses is similar to that found in normal serum. The measured buffer capacity is 35 mEq/L and the osmolality is 258 mOsmol/kg solvent, which is close to physiological osmolality (285-295 mOsmol/kg). The pH of GAMUNEX® is 4.0-4.5. GAMUNEX® contains no preservative.
GAMUNEX®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, is indicated as replacement therapy of primary immunodeficiency states in which severe impairment of antibody forming capacity has been shown, such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked immunodeficiency with hyper IgM, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies17-24.
GAMUNEX® is indicated in Idiopathic Thrombocytopenic Purpura to rapidly raise platelet counts to prevent bleeding or to allow a patient with ITP to undergo surgery5-10.
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