Recorded Chinese product: 盐酸二氢埃托啡片盐酸二氢埃托啡片
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
- 北京华素制药股份有限公司Chinese legal name: 北京华素制药股份有限公司
主要成分Active Ingredients
- 活性成份二氢埃托啡Huoxing Chengfen Erqing Aituo Fei
药物知识说明
活性成份二氢埃托啡是一种在国家药监局注册认定的药品。标注生产企业为北京华素制药股份有限公司。
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：北京华素制药股份有限公司Chinese legal name: 北京华素制药股份有限公司、北京华素制药股份有限公司Chinese legal name: 北京华素制药股份有限公司、北京华素制药股份有限公司Chinese legal name: 北京华素制药股份有限公司。
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: 盐酸二氢埃托啡片) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 北京华素制药股份有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 北京华素制药股份有限公司Chinese legal name: 北京华素制药股份有限公司, 北京华素制药股份有限公司Chinese legal name: 北京华素制药股份有限公司, 北京华素制药股份有限公司Chinese legal name: 北京华素制药股份有限公司.
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: 盐酸二氢埃托啡片Recorded Chinese product: 盐酸二氢埃托啡片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 20μg*10s20 μg × 10s
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
- 北京华素制药股份有限公司Chinese legal name: 北京华素制药股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20000403
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H20000403
Manufacturer
Chinese legal name: 北京华素制药股份有限公司 (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H20000403
生产企业
北京华素制药股份有限公司(国产)
适应症
本品仅限用于创伤、手术后及诊断明确的各种剧烈疼痛的止痛，包括对吗啡或哌替啶无效者。
用法用量
舌下含化20-40μg，经10-15分钟疼痛可获明显减轻，视需要可于3-4小时后重复用药，只可舌下含化，不可将药片吞服，否则影响止痛效果。允许使用最大剂量一般为60μg，一日180μg，连续用药不得超过三天。超大剂量使用时应遵医嘱。
不良反应
本品用于各种疼痛病例时，在治疗剂量下一般无明显不良反应，少数病人可出现头晕、恶心、呕吐、乏力、出汗，卧床病人比活动病人反应轻。这些反应可不经任何处理而缓解。偶见呼吸减慢至每分钟10次左右，用呼吸兴奋药尼可刹米可纠正，也可用吸氧纠正。未见吗啡样致便秘作用。
禁忌
1．脑外伤神志不清或肺功能不全者禁用。
2．婴幼儿、未成熟新生儿禁用。
3．非剧烈疼痛病例如牙痛、头痛、风湿痛、痔疮痛或局部组织小创伤痛等不宜使用。
注意事项
1．本品为国家特殊管理的麻醉药品，应在医生指导下使用，务必严格遵守国家对麻醉药品的管理条例，医院和病室的贮药处均须加锁，处方颜色应与其他药处方区别开。各级负责保管人员均应遵守交接班制度，不可稍有疏忽。
贮藏
遮光，密封保存。
规格
20μg*10s
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.