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- W2088392367 abstract "Background and Objectives The aim of this study was to evaluate the pharmacokinetics, efficacy and safety of a newly developed 10% liquid immunoglobulin preparation in patients with primary immunodeficiency diseases. This new preparation for intravenous use includes three dedicated virus clearance steps in its manufacturing process to ensure a high margin of viral safety. Materials and Methods This was a prospective, open‐label, non‐controlled, multicentre study. Twenty‐two subjects with primary immunodeficiency were treated initially with three infusions of a licensed intravenous immunoglobulin to standardize the immunoglobulin G (IgG) replacement therapy of all subjects to the same intravenous product. A total of nine infusions of the new 10% liquid preparation were subsequently administered. Results The median terminal half‐life of total IgG following administration of the new preparation was 30·1 days. Median terminal half‐lives for IgG subclasses IgG 1 , IgG 2 , IgG 3 and IgG 4 were 28·3, 31·3, 20·9 and 24·2 days, respectively. The median total serum IgG steady‐state trough level was 8·51 g/l. No severe infection episodes started after initiation of treatment with the new preparation. The median rate of mild or moderate infection episodes was 0·48 per month. A total of 194 infusions with the new 10% liquid immunoglobulin preparation were administered. The mean dose per infusion was 0·41 g/kg body weight and the maximum infusion rates recorded were 8 ml/kg/h. Adverse experiences were mostly mild and unrelated to the study drugs. Only 4% of infusions with the new product were followed by one or more related adverse experiences. Conclusion The new 10% liquid immunoglobulin preparation was well tolerated and shown to have an excellent pharmacokinetic, efficacy and safety profile. The liquid formulation provides convenience to patients and healthcare professionals." @default.
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- W2088392367 date "2006-03-15" @default.
- W2088392367 modified "2023-10-17" @default.
- W2088392367 title "Prospective open‐label study of pharmacokinetics, efficacy and safety of a new 10% liquid intravenous immunoglobulin in patients with hypo‐ or agammaglobulinemia" @default.
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- W2088392367 doi "https://doi.org/10.1111/j.1423-0410.2006.00764.x" @default.
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