Recorded Chinese product: 枸橼酸他莫昔芬片枸橼酸他莫昔芬片
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。
批准文号:NMPA approval number: 国药准字J20050005
生产企业Manufacturer
- Rottendorf Pharma GmbH
主要成分Active Ingredients
- 他莫西芬Tamo Xifen
药物知识说明
国药准字J20050005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：他莫西芬Tamo Xifen。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：他莫西芬-00d3f795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: 枸橼酸他莫昔芬片) is a medicine registered with the national drug regulatory authority. It contains active ingredient(s) as recorded.
Active ingredients associated with this product: 他莫西芬Tamo Xifen.
Explore other medicines containing the same ingredient: 他莫西芬 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: 枸橼酸他莫昔芬片Recorded Chinese product: 枸橼酸他莫昔芬片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 10mg,100片/ 瓶.Recorded Chinese composition: 10mg,100片/ 瓶.
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
- Rottendorf Pharma GmbH
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字J20050005
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J20050005
Manufacturer
Rottendorf Pharma GmbH (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
English translation unavailable. The original Chinese source label remains available below.
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J20050005
生产企业
Rottendorf Pharma GmbH(国产)
适应症
主要用于晚期乳癌或手术后经放疗、化疗仍不能控制者。
用法用量
日剂量可单次服用,也可分成两个相等剂量服用。他莫昔芬治疗乳腺癌的常规日剂量为20mg至40mg。
不良反应
治疗初期骨和肿瘤疼痛可一过性加重继续治疗可逐渐减轻。少数病人有不良反应。
1.胃肠道反应：食欲不振、恶心、呕吐、腹泻。
2.生殖系统：月经失调，闭经，阴道出血，外阴瘙痒，子宫内膜增生，内膜息肉和内膜癌。
3.皮肤：颜面潮红，皮疹，脱发。
4.骨髓：偶见白细胞和血小板减少。肝功偶见异常。
5.眼睛：长时间（17个月以上）大量（每天240-320mg）使用可出现视网膜病或角膜浑浊。
6.罕见的、需引起注意的不良反应：精神错乱，肺栓塞（表现为气短），血栓形成，无力，嗜睡。
禁忌
1.在妊娠或哺乳期间不应使用他莫昔芬。
2.在孕妇中曾经有关于自发性流产,出生缺陷和胎儿死亡的少量报告,但是尚未确定因果关系。\\\\
3.他莫昔芬也禁用于已知对本品或其中所含组份过敏的患者。
注意事项
1.有肝功能异常者应慎用。如有骨转移，在治疗初期需定期查血钙。
2.运动员慎用。
贮藏
室温（15℃－25℃）干燥处保存。 请将药物置于儿童不能触及处。
规格
10mg,100片/ 瓶.
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.