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231224s2011 xx |||||o 00| ||eng c |
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|a 10.1016/j.clim.2011.06.002
|2 doi
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|a pubmed24n0698.xml
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|a (DE-627)NLM209474068
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|a (NLM)21705277
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|a DE-627
|b ger
|c DE-627
|e rakwb
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|a eng
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| 100 |
1 |
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|a Jolles, S
|e verfasserin
|4 aut
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|a Efficacy and safety of Hizentra(®) in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy
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|c 2011
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|a Text
|b txt
|2 rdacontent
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|a ƒaComputermedien
|b c
|2 rdamedia
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|a ƒa Online-Ressource
|b cr
|2 rdacarrier
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|a Date Completed 21.11.2011
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|a Date Revised 29.09.2011
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|a published: Print-Electronic
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|a Citation Status MEDLINE
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|a Copyright © 2011 Elsevier Inc. All rights reserved.
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|a A prospective, open-label, multicenter, single-arm, Phase III study evaluated the efficacy and safety of Hizentra(®), a 20% human IgG for subcutaneous administration, in 51 primary immunodeficiency patients over 40 weeks. Patients previously on intravenous or subcutaneous IgG were switched to weekly subcutaneous infusions of Hizentra(®) at doses equivalent to their previous treatment. IgG levels achieved with Hizentra(®) were similar to pre-study levels with subcutaneous, and higher by 17.7% than pre-study levels with intravenous IgG. No serious bacterial infections were reported in the efficacy period. The rate of all infections was 5.18/year/patient, the rates of days missed from work/school, and days spent in hospital were 8.00/year/patient and 3.48/year/patient, respectively. Local reactions (rate 0.060/infusion) were mostly mild (87.3%). No serious, Hizentra(®)-related adverse events were reported. Individual median infusion durations ranged between 1.14 and 1.27 h. Hizentra(®) maintained or improved serum IgG levels without dose increases and effectively protected patients against infections
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|a Clinical Trial, Phase III
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|a Comparative Study
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|a Journal Article
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|a Multicenter Study
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|a Research Support, Non-U.S. Gov't
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|a Hizentra
|2 NLM
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| 650 |
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|a Immunoglobulin G
|2 NLM
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| 650 |
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|a Immunoglobulins, Intravenous
|2 NLM
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|a Bernatowska, E
|e verfasserin
|4 aut
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|a de Gracia, J
|e verfasserin
|4 aut
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|a Borte, M
|e verfasserin
|4 aut
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|a Cristea, V
|e verfasserin
|4 aut
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|a Peter, H H
|e verfasserin
|4 aut
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|a Belohradsky, B H
|e verfasserin
|4 aut
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|a Wahn, V
|e verfasserin
|4 aut
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| 700 |
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|a Neufang-Hüber, J
|e verfasserin
|4 aut
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|a Zenker, O
|e verfasserin
|4 aut
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|a Grimbacher, B
|e verfasserin
|4 aut
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| 773 |
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|i Enthalten in
|t Clinical immunology (Orlando, Fla.)
|d 1999
|g 141(2011), 1 vom: 02. Okt., Seite 90-102
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|x 1521-7035
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|g volume:141
|g year:2011
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|g pages:90-102
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|u http://dx.doi.org/10.1016/j.clim.2011.06.002
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