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Prospective open-la...
Prospective open-label study of pharmacokinetics, efficacy and safety of a new 10% liquid intravenous immunoglobulin in patients with hypo- or agammaglobulinemia
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Bjorkander, J (author)
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Nikoskelainen, J (author)
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Leibl, H (author)
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- Lanbeck, Peter (author)
- Lund University,Lunds universitet,Enheten för infektionssjukdomar,Forskargrupper vid Lunds universitet,Infectious Diseases Research Unit,Lund University Research Groups
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Wallvik, J (author)
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Lumio, JT (author)
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- Braconier, Jean Henrik (author)
- Lund University,Lunds universitet,Infektionsmedicin,Sektion III,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Infection Medicine (BMC),Section III,Department of Clinical Sciences, Lund,Faculty of Medicine
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Pavlova, BG (author)
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Birthistle, K (author)
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Engl, W (author)
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Walter, S (author)
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Ehrlich, HJ (author)
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(creator_code:org_t)
- Wiley, 2006
- 2006
- English.
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In: Vox Sanguinis. - : Wiley. - 1423-0410 .- 0042-9007. ; 90:4, s. 286-293
- Related links:
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http://dx.doi.org/10...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
Keyword
- pharmacokinetics
- immunoglobulin
- IVIG
- primary immunodeficiency
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Bjorkander, J
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Nikoskelainen, J
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Leibl, H
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Lanbeck, Peter
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Wallvik, J
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Lumio, JT
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show more...
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Braconier, Jean ...
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Pavlova, BG
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Birthistle, K
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Engl, W
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Walter, S
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Ehrlich, HJ
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Hematology
- Articles in the publication
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Vox Sanguinis
- By the university
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Lund University