Recorded Chinese product: 醋酸甲羟孕酮分散片醋酸甲羟孕酮分散片

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

甲羟孕酮是一种在国家药监局注册认定的药品。该药品含有甲羟孕酮-ce25332f等成分。

该药品关联的活性成分包括:甲羟孕酮Jiaqiang Yuntong。这些成分信息来自国家药监局数据库。

该药品标注的生产企业为:浙江仙琚制药股份有限公司Chinese legal name: 浙江仙琚制药股份有限公司。

您可以探索含有相同成分的其他药品:甲羟孕酮-ce25332f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: 醋酸甲羟孕酮分散片) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: 甲羟孕酮Jiaqiang Yuntong.

Manufacturers recorded for this product: 浙江仙琚制药股份有限公司Chinese legal name: 浙江仙琚制药股份有限公司.

Explore other medicines containing the same ingredient: 甲羟孕酮 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: 醋酸甲羟孕酮分散片Recorded Chinese product: 醋酸甲羟孕酮分散片
  • 剂型Dosage form: 片剂Tablets
  • 规格Specification: 0.1g0.1 g

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

  • 浙江仙琚制药股份有限公司Chinese legal name: 浙江仙琚制药股份有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H20103709

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H20103709

Manufacturer

Chinese legal name: 浙江仙琚制药股份有限公司 (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

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H20103709

生产企业

浙江仙琚制药股份有限公司(国产)

适应症

本品用于不能手术、复发性或转移性激素依赖性肿瘤的姑息治疗或辅助治疗,如子宫内膜癌、肾癌、乳腺癌等。

用法用量

本品服用须经医嘱。子宫内膜癌及肾癌:每日0.2~0.4g;乳腺癌:每日0.4~0.8g,甚至每日高达1g,性激素疗法至少需要治疗8至10周才有反应。各种癌症病人恶液质及疼痛的姑息治疗:每日0.5~1g。对各种癌症化疗时保护骨髓作用:每日0.5~1g(由化疗前一周至一个疗程后一周)。

不良反应

1.和其它孕酮类药物相似,可能出现乳房痛、溢乳、闭经、子宫颈糜烂或子宫颈分泌改变以及男性乳房女性化。|2.精神方面:神经质、失眠、嗜眠、疲劳、头晕。|3.皮肤与粘膜:过敏反应包括瘙痒、荨麻疹、血管神经性水肿至全身性皮疹及无防御性反应等曾被报告,也曾报告少数病例有痤疮、秃发或多毛。|4.胃肠道:恶心及消化不良,尤其在较大剂量情况下。亦可能产生类似肾上腺皮质醇反应及高血钙反应,偶有阻塞性黄疸的报导。

禁忌

对醋酸甲羟孕酮及本品其它任何成份过敏者,各种血栓栓塞性疾病(血栓性静脉炎、肺栓塞等),严重肝功能损害,因骨转移产生的高钙血症,月经过多,妊娠或哺乳期妇女禁用。

注意事项

1、本药须在有经验的临床医师指导下使用,一旦出现因该药增强凝血机制而致血栓栓塞症状如偏头痛、视力减退、复视等情况时应立即停药。|2、在连续大剂量MPA治疗时应注意有无高血症、水钠潴留、高血钙症候等,如出现这些症状应调整用药。|3、本品可能会引起一定程度体液潴留。患有癫痫、偏头痛、气喘、心脏功能不全或肾脏功能不全者,使用本品时应谨慎观察。|4、有抑郁病史的病人需仔细观察,若忧郁复发到严重程度需停止用药。某些病人使用孕激素时,对葡萄糖耐受性降低,因此糖尿病患者应慎用。|5.对本品过敏者禁用,过敏体质者慎用,本品性状发生改变时禁止使用。|6.如正在使用其他药品,使用本品前请咨询医师或药师。|7.请将本品放在儿童不能接触的地方。

贮藏

遮光,密封保存

规格

0.1g

证据Evidence

  • 批准文号: 国药准字H20103709
  • 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.