美国药品说明书目录Word文档下载推荐.doc

1、2. Dosage and Administration用量与用法Recommended Dose推荐用量；Dosage Adjustments/Dose Modification用量调整3. Dosage Forms and Strengths剂型与规格4. Contraindications禁忌证5. Warnings and Precautions注意事项6. Adverse Reactions不良反应（含统计数据）7. Drug Interactions药物相互作用8. Use in Specific Populations特殊人群用药Pregnancy妊娠；Labor and del

2、ivery分娩；Nursing Mothers哺乳期妇女；Pediatric Use小儿用药；Geriatric Use老人用药；Hepatic Impairment肝功能不全；Renal Impairment肾功能不全9. Drug Abuse and Dependence药物滥用和依赖性（部分药品无）Controlled Substance管制药物；10. Overdosage用药过量11. Description性状（含化学名称，分子式，分子量，结构式，理化性质）12. Clinical Pharmacology临床药理学Mechanism of Action作用机理；Pharmacod

3、ynamics药效动力学；Pharmacokinetics药代动力学13. Nonclinical Toxicology非临床毒理学Carcinogenesis致癌；Mutagenesis致突变；Impairment of Fertility生殖毒性Animal toxicology and/or pharmacology动物毒理学和/或药理学14. Clinical Studies临床研究15. References参考（部分药品无）16. How Supplied/Storage and Handling包装与贮藏17. Patient Counseling Information患者咨询信息