Clinical use of a new pH 4.25 intravenous immunoglobulin preparation (gamimune-N).
A multicentre, randomised, double-blinded, cross-over study was done to evaluate the clinical use and safety of a new immunoglobulin preparation for intravenous use (IVIgG). This reagent, IVIgG pH 4.25, was compared to a standard commercially available preparation IVIgG pH 6.8. Thirty-nine patients with primary immunodeficiency disease received a total of 232 infusions at a dose of 400 mg/kg every 4 weeks. Adverse effects from such infusions were transient and minimal. Clinically significant abnormalities did not occur. There were no statistically significant differences between the results for IVIgG pH 6.8 and for the new IVIgG pH 4.25 preparation. It was possible to infuse the new IVIgG pH 4.25 reagent at rates of 0.1 ml (5.0 mg)/kg/min without inducing vasomotor adverse effects.
D000293:Adolescent; D000328:Adult; D000361:Agammaglobulinemia / Q000628:therapy; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007074:Immunoglobulin G / Q000008:administration & dosage / Q000627:therapeutic use*; D016756:Immunoglobulins, Intravenous; D007153:Immunologic Deficiency Syndromes / Q000628:therapy*; D007223:Infant; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011897:Random Allocation
D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous