Futa An Pian (氟他胺片)氟他胺片

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

主要成分Active Ingredients

药物知识说明

氟他胺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复旦复华药业有限公司。

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:上海复旦复华药业有限公司Chinese legal name: 上海复旦复华药业有限公司、上海复旦复华药业有限公司Chinese legal name: 上海复旦复华药业有限公司、上海复旦复华药业有限公司Chinese legal name: 上海复旦复华药业有限公司。

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: 氟他胺片) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 上海复旦复华药业有限公司.

No active ingredient relationships are currently recorded for this product in MedicineGraph.

Manufacturers recorded for this product: 上海复旦复华药业有限公司Chinese legal name: 上海复旦复华药业有限公司, 上海复旦复华药业有限公司Chinese legal name: 上海复旦复华药业有限公司, 上海复旦复华药业有限公司Chinese legal name: 上海复旦复华药业有限公司.

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: 氟他胺片Recorded Chinese name: 氟他胺片
  • 剂型Dosage form: 片剂Tablets
  • 规格Specification: 0.25g*20片0.25 g × 20 tablets

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

  • 上海复旦复华药业有限公司Chinese legal name: 上海复旦复华药业有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H10950220

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H10950220

Manufacturer

Chinese legal name: 上海复旦复华药业有限公司 (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

English translation unavailable. The original Chinese source label remains available below.

Specification

0.25 g × 20 tablets

中文说明书原文Original Chinese source label

批准文号

国药准字H10950220

生产企业

上海复旦复华药业有限公司(国产)

适应症

适用于前列腺癌,对初治及复治患者都可有效。

用法用量

1.治疗局限性前列腺癌症的推荐剂量为每日三次,间隔8小时,每次250mg。 2.如果还使用LHRH激动剂,本品应与LHRH激动剂同时川药或提前24小时川药。 3.本品必须在放疗前8周开始使川,且在放疗期间持续使用。

不良反应

男性乳房女性化,乳房触痛,有时伴有溢乳,如减少剂量或停药则可消失。少数患者可有腹泻、恶心、呕吐、食欲增加、失眠和疲劳。罕见性欲减低、一过性肝功能异常及精子计数减少。本品对心血管的潜在性影响比己烯雌酚小。

禁忌

对本品过敏者禁用。

注意事项

需长期服用本品时应定期检查肝功能和精子计数,如发生异常应减量或停药,一般可恢复正常。本品可增加睾丸酮和雌二醇的血浆浓度,可能发生体液潴留。本品可单独应用,也可与LHRH激动剂、化疗药物联合应用。对良性前列腺增生也有一定的疗效。

贮藏

贮藏于2~30℃避光、防潮、避开儿童。

规格

0.25g*20片

证据Evidence

  • 批准文号: 国药准字H10950220
  • rights: 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。

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.