Clinical relevance of information in the Summaries of Product Characteristics for dose adjustment in renal impairment
作者: Teresa M. SalgadoBlanca ArguelloFernando Martinez-MartinezShalom I. BenrimojFernando Fernandez-Llimos
作者单位: 1Research Institute for Medicines and Pharmaceutical Sciences (iMed.UL), Faculty of Pharmacy, University of Lisbon
2Cátedra de Atención Farmacéutica, Facultad de Farmacia de Granada, University of Granada
3Graduate School of Health, University of Technology Sydney
4Research Institute for Medicines and Pharmaceutical Sciences (iMed.UL), Department of Social Pharmacy, Faculty of Pharmacy, University of Lisbon
刊名: European Journal of Clinical Pharmacology, 2013, Vol.69 (11), pp.1973-1979
来源数据库: Springer Nature Journal
DOI: 10.1007/s00228-013-1560-2
关键词: Clinical decision support systemsDose adjustmentDrug labellingPhysician order entry systemsRenal impairment
原始语种摘要: Abstract(#br) Purpose(#br)Information about dosing adjustments in patients with chronic kidney disease is important to avoid toxicity for several medicines. The aim of our study was to assess the clinical relevance of the instructions for dose adjustment in patients with renal impairment provided in the Summaries of Product Characteristics (SmPCs) approved by the European Medicines Agency (EMA).(#br) Methods(#br)SmPCs available on the EMA website on April 2011 were retrieved, and information on the elimination route and instructions for use in renal impairment was analysed independently by two of the authors. SmPCs were classified as containing ‘explicit’ or ‘poor’ information based on whether they presented (or not) instructions for use of the medicine in renal impairment. Information...
全文获取路径: Springer Nature  (合作)
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来源刊物:
影响因子:2.741 (2012)

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关键词翻译
关键词翻译
  • adjustment 
  • information 报告
  • impairment 减损
  • renal 肾的
  • relevance 关联性