H-化学药品、生物制品说明书指导原则(第二稿) 20080904.docVIP

精品资料 精品资料 PAGE / NUMPAGES 精品资料 【 H 】 G C L 5 - 1 指导原则编号： 化学药品、生物制品说明书指导原则 （第二稿） 二 00 四年三月一日 1 目 录 一．概述 ························ 4 二．药品说明书形式与内容的一般要求 ··········· 4 三．说明书形式与内容的具体要求 ············· 8 （一）标题························································································8 （二）警示语····················································································8 （三）药品名称·················································································8 （四）成份························································································9 （五）性状························································································9 （六）处方组成·················································································9 （七）药理毒理·················································································9 （八）药代动力学···········································································10 （九）临床研究···············································································11 （十）适应证··················································································11 （十一）用法用量···········································································12 （十二）不良反应···········································································13 （十三）禁忌··················································································14 （十四）警告··················································································15 （十五）注意事项···········································································16 （十六）妊娠期妇女及哺乳期妇女用药·······································17 （十七）儿童用药···········································································19 （十八）老年患者用药···································································20 2 （十九）药物相互作用······························