Recorded Chinese product: 单盐酸氟西泮胶囊单盐酸氟西泮胶囊
This is a medicine registration record from NMPA data.本页为国家药监局药品注册记录。
Labeled sections from the recorded Chinese source are included below. English wording is a reference translation when one is on file, not an official English label.本记录未接入产品级适应症/安全性标注字段。
生产企业Manufacturer
- 上海衡山药业有限公司Chinese legal name: 上海衡山药业有限公司
主要成分Active Ingredients
- 单氟西泮Danfu Xipan
药物知识说明
单氟西泮是一种在国家药监局注册认定的药品。标注生产企业为上海衡山药业有限公司。
该药品暂无关联的活性成分信息。
该药品标注的生产企业为：上海衡山药业有限公司Chinese legal name: 上海衡山药业有限公司、上海衡山药业有限公司Chinese legal name: 上海衡山药业有限公司、上海衡山药业有限公司Chinese legal name: 上海衡山药业有限公司。
本页面内容来自国家药监局数据库，MedicineGraph在此基础上提供关系图谱和知识导航。
Medicine Knowledge
This medicine (original name: 单盐酸氟西泮胶囊) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 上海衡山药业有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 上海衡山药业有限公司Chinese legal name: 上海衡山药业有限公司, 上海衡山药业有限公司Chinese legal name: 上海衡山药业有限公司, 上海衡山药业有限公司Chinese legal name: 上海衡山药业有限公司.
Source: MedicineGraph authoritative database. Relationships derived from registered product information.
这是什么What is this
- 通用名/品名Recorded product name: 单盐酸氟西泮胶囊Recorded Chinese product: 单盐酸氟西泮胶囊
- 剂型Dosage form: 胶囊剂Capsules
- 规格Specification: 30mg30 mg
本段仅展示注册/说明书已记录的身份属性，不含适应症或用法建议。Identity attributes from registration/leaflet records only; no indications or usage advice.
生产企业Manufacturer
- 上海衡山药业有限公司Chinese legal name: 上海衡山药业有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H31021384
关联实体Relationships
信息来源Source and scope
国家药品监督管理局（中国）药品注册数据及已接入说明书字段。National Medical Products Administration (China) medicine-registration data and linked leaflet fields.
- 品名来源Name source: 10多万条药品说明书数据库 (HIGH)Package-insert database (more than 100,000 records) (HIGH)
- 生产企业来源Manufacturer source: 10多万条药品说明书数据库Package-insert database (more than 100,000 records)
- 剂型来源Dosage-form source: 10多万条药品说明书数据库Package-insert database (more than 100,000 records)
范围：当前 MedicineGraph 注册记录及已记录的精确关系；非完整目录，亦不构成疗效等同主张，也不支持换用判断。不含适应症/安全性推断。Scope: current MedicineGraph registration records and exact recorded relationships; not a complete catalog and not a claim of therapeutic equivalence. No inferred indications/safety.
本段为已核准说明书原文摘录（非改写、非AI摘要），非正式英文标签，亦不构成用药建议。 Not an official English label and not medical advice. English wording, when shown, is a reference translation of the Chinese source label.
English translation for reference. Translated from the Chinese source label. Not an official English label and not medical advice.
NMPA approval number
国药准字H31021384
Manufacturer
Chinese legal name: 上海衡山药业有限公司 (domestically manufactured)
Indications
English translation unavailable. The original Chinese source label remains available below.
Dosage and administration
English translation unavailable. The original Chinese source label remains available below.
Adverse reactions
English translation unavailable. The original Chinese source label remains available below.
Contraindications
English translation unavailable. The original Chinese source label remains available below.
Precautions
English translation unavailable. The original Chinese source label remains available below.
Storage
Protect from light and keep tightly closed.
Specification
English translation unavailable. The original Chinese source label remains available below.
中文说明书原文Original Chinese source label
批准文号
国药准字H31021384
生产企业
上海衡山药业有限公司(国产)
适应症
用于治疗各种失眠，如入睡困难，夜间多梦，和早醒。对反复发作的失眠或睡眠障碍以及需睡眠休息的急慢性疾病均有效。
用法用量
按氟西泮计算成人口服15~30mg，睡前服。老年或体弱者一次15mg。
不良反应
1、最常见的不良反应是醒后有思睡的后遗症状，较常见的不良反应是嗜睡，头昏、乏力等，大剂量可有共济失调、震颤。此外尚有严重镇静、嗜睡、定向障碍、昏迷、头痛、神经过敏多语、易激动、胃肠不适、心悸、胸痛，肢体和关节及泌尿生殖道反应。|2、罕见的有皮疹、白细胞减少。|3、个别病人发生兴奋，多语，睡眠障碍，甚至幻觉。停药后，上述症状很快消失。|4、有成瘾性，长期应用后，停药可能发生撤药症状，表现为激动或忧郁。
禁忌
对其它苯二氮卓药物过敏者，可能对本药过敏，禁用。
注意事项
1、为防止依赖性的发生，本品不易反复、多次应用。|2、肝肾功能损害者能延长本品清除半衰期。需反复应用者应定期检查肝、肾功能。|3、严重的精神抑郁可使病情加重，甚至产生自杀倾向，应采取预防措施。|4、如长期使用应逐渐减量，不宜骤停。|5、服药期间忌酒，服药前4小时避免喝茶和含咖啡因的饮料及过多的抽烟，以免减弱本品效果。|6、服药后应避免立即驾驶车辆、操纵机器或高空作业等。|7、对本类药耐受量小的患者初用量易小，逐渐增加剂量。|8、本药在连续用药第2天或第3天效果增大，停药后第1~2天仍维持药效。|9、慎用者：|（1）中枢神经系统处于抑制状态的急性酒精中毒。|（2）肝肾功能损害。|（3）重症肌无力。|（4）急性或易于发生的闭角型青光眼发作。|（5）严重慢性阻塞性肺部病变。
贮藏
遮光，密闭保存。
规格
30mg
信息来源Source and scope
国家药品监督管理局（中国）药品注册数据。National Medical Products Administration (China) medicine-registration data.
范围：当前 MedicineGraph 注册记录及已记录的精确关系；非完整目录，亦不构成疗效等同主张，也不支持换用判断。Scope: current MedicineGraph registration records and exact recorded relationships; not a complete catalog and not a claim of therapeutic equivalence.