化学药品、生物制品说明书指导原则.pdf

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指导原则编号: H GC L 5 - 1



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
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目录
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··········· 4
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(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
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(十九)药物相互作用··································································· 21
(二十)药物过量····································