临床病例报告引发蔗糖铁类似制剂同蔗糖铁原始制剂治疗等效性的疑问

Clinical case reports raise doubts about the therapeutic equivalence of an iron sucrose similar preparation compared with iron sucrose originator
2012-09-30 15:37点击:32次发表评论
作者:Jürgen Steina, Axel Dignassa, Kai Uwe Chowb Read
期刊: CURR MED RES OPIN2012年2月2期28卷

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Intravenous iron sucrose has been used to treat iron deficiency and iron deficiency anaemia associated with different chronic diseases for several decades. Despite the complex structure of iron sucrose, copies called iron sucrose similars (ISSs) have been approved according to the generic approach and therefore, therapeutic equivalence is taken for granted. In February 2011, three patients who previously tolerated well the prescribed iron sucrose originator experienced urticaria, oedema and headache within 1 hour after infusion of an ISS that had been substituted for the origina


学科代码:血液病学   关键词:Anaemia Interchangeability Iron deficiency Iron sucrose similar Non-biological complex drugs Substitutability Read More:
来源: Current Medical Research & Opinion
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