title: [Tolerance of a new intravenously applied immunoglobulin preparation and its effect on serum globulin levels].
abstract: In a controlled prospective study, 212 patients were evaluated in 13 different hospitals with regard to the clinical tolerance of a new gammaglobulin preparation which can be administered intravenously. The age of the patients ranged from one day to 83 years. Patients with a primary or secondary immunoglobulin deficiency and patients with normal serum immunoglobulin concentrations were included in the study. In 811 infusions a total of 7128 g gammaglobulin were applied; the maximum dosage was 30 g/day. We saw a transient, recurrent and spontaneously reversible fever reaction in one patient with long-term substitution because of a primary immunodeficiency syndrome. Otherwise, no serious side-effects were seen in clinical or laboratory controls. Patients controlled for their serum gammaglobulin concentrations before and after the infusions showed a significant rise of 112.5 mg/100 ml for each infusion of 3 g gammaglobulin. The new preparation also showed an estimated half-life of 23 days, thus making it a good possibility for long-term substitution in immunodeficient patients.
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004361:Drug Tolerance; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis / Q000627:therapeutic use*; D016756:Immunoglobulins, Intravenous; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy* / Q000276:immunology; D007223:Infant; D007231:Infant, Newborn; D007263:Infusions, Parenteral; D008875:Middle Aged; D005719:gamma-Globulins / Q000378:metabolism*
chemical_list: D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous; D005719:gamma-Globulins
vernacular_title: Verträglichkeit eines neuen, intravenös applizierbaren Immunglobulinpräparats und sein Effekt auf die Serumglobulinkonzentration.