17化学药品、生物制品说明书指导原则.pdf

【 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··································································· 21 （二十）药物过量································································