Fufang Difen Nuozhi Pian (复方地芬诺酯片)复方地芬诺酯片
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
- 郑州瑞康制药有限公司Chinese legal name: 郑州瑞康制药有限公司
主要成分Active Ingredients
- 地芬诺酯Difen Nuozhi
- 另一组分为阿托品Lingyi Zufen Weia Tuopin
药物知识说明
地芬诺酯是一种在国家药监局注册认定的药品。该药品含有相关活性成分。
该药品关联的活性成分包括：另一组分为阿托品、地芬诺酯Difen Nuozhi。这些成分信息来自国家药监局数据库。
您可以探索含有相同成分的其他药品：另一组分为阿托品-4112c379成分药品。
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: 复方地芬诺酯片) is a medicine registered with the national drug regulatory authority. It contains active ingredient(s) as recorded.
Active ingredients associated with this product: 地芬诺酯Difen Nuozhi.
Explore other medicines containing the same ingredient: 另一组分为阿托品 productsProducts containing this recorded ingredient.
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: 复方地芬诺酯片Recorded Chinese name: 复方地芬诺酯片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 盐酸地芬诺酯2.5mg,硫酸阿托品25ugRecorded Chinese specification: 盐酸地芬诺酯2.5mg,硫酸阿托品25ug
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.
主要成分Ingredients
生产企业Manufacturer
- 郑州瑞康制药有限公司Chinese legal name: 郑州瑞康制药有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H41020792
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H41020792
Manufacturer
Chinese legal name: 郑州瑞康制药有限公司 (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
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H41020792
生产企业
郑州瑞康制药有限公司(国产)
适应症
本品用于急慢性功能性腹泻及慢性肠炎。
用法用量
口服。
1.成人：每次1～2片，每日2～3次，首剂加倍，饭后服，至腹泻控制时，即可减少剂量。
2.小儿：
(1)8～12岁，每次1片，每日4次。
(2)6～8岁，每次1片，每日3次。
(3)2～5岁，每次1片，每日2次。
不良反应
不良反应少见，服药后偶见口干，恶心，呕吐，头痛，嗜睡，抑郁，烦躁，失眠，皮疹，腹胀及肠梗阻等，减量或停药后消失。
禁忌
1. 严重溃疡性结肠炎病人有发生中毒性巨结肠可能，应禁用。
2. 肝硬化、黄疸患者因可诱发肝性脑病，应慎用。
注意事项
1. 本品长期应用时可产生依赖性，但显然较阿片为弱，肝病患者及正在服用成瘾性药物患者宜慎用。
2. 只宜用常量短期治疗，以免产生依赖性。
3. 腹泻早期和腹胀者应慎用。
4. 由痢疾杆菌，沙门氏菌和某些大肠杆菌引起的急性腹泻，细菌常侵入肠壁粘膜，本品降低肠运动，推迟病原体的排除，反而延长病程，故本品不能用作细菌性腹泻的基本治疗药物。
贮藏
密封保存。
规格
盐酸地芬诺酯2.5mg,硫酸阿托品25ug
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.