化学药品及中药的药品说明书撰写原则

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1、【H】GCL5-1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······································

2、··············································8（三）药品名称·················································································8（四）成份························································································9（五）性状·······································

3、·················································9（六）处方组成·················································································9（七）药理毒理·················································································9（八）药代动力学······································

4、·····································10（九）临床研究···············································································11（十）适应证··················································································11（十一）用法用量·················································

5、··························12（十二）不良反应···········································································13（十三）禁忌··················································································14（十四）警告·································································

6、·················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·················

7、··················································202（十九）药物相互作用···································································21（二十）药物过量···········································································22（二十一）规格··················································

8、·····························22（二十二）贮藏············································