Recorded Chinese product: 达那唑胶囊达那唑胶囊

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

达那唑是一种在国家药监局注册认定的药品。该药品含有达那唑-1051214a等成分。

该药品关联的活性成分包括:达那唑Dana Zuo。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:广州柏赛罗药业有限公司Chinese legal name: 广州柏赛罗药业有限公司。

您可以探索含有相同成分的其他药品:达那唑-1051214a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: 达那唑胶囊) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: 达那唑Dana Zuo.

Manufacturers recorded for this product: 广州柏赛罗药业有限公司Chinese legal name: 广州柏赛罗药业有限公司.

Explore other medicines containing the same ingredient: 达那唑 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: 达那唑胶囊Recorded Chinese product: 达那唑胶囊
  • 剂型Dosage form: 胶囊剂Capsules
  • 规格Specification: 100mg*30粒/盒Recorded Chinese specification: 100mg*30粒/盒

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

  • 广州柏赛罗药业有限公司Chinese legal name: 广州柏赛罗药业有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H20023742

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H20023742

Manufacturer

Chinese legal name: 广州柏赛罗药业有限公司 (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

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H20023742

生产企业

广州柏赛罗药业有限公司(国产)

适应症

本品用于子宫内膜异位症的治疗,也可用于治疗纤维囊性乳腺病、自发性血小板减少性紫癜、遗传性血管性水肿、系统性红斑狼疮、男子女性化乳房、青春期性早熟。

用法用量

1.子宫内膜异位症,一日量400~800mg,分次服用,连服3~6个月,如停药后症状再出现,可再给药一疗程;(在肝功正常情况下)|2.纤维囊性乳腺病,于月经开始后第一天服药,一次50~200mg,每日2次,如停药后一年内症状复发,可再给药;|3.遗传性血管性水肿,开始一次200mg,每日2~3次,直到疗效出现,维持量一般是开始量的50%或更少,在1~3个月或更长一段的间隔时间递减,根据治疗前发病的频率而定。

不良反应

1.较多见的不良反应:|闭经,突破性子宫出血,并可有乳房缩小、音哑、毛发增多。可出现痤疮、皮肤或毛发的油脂增多、下肢浮肿或体重增多,症状与药量有关,是雄激素效应的表现。|2.较少见的不良反应:|血尿、鼻衄、牙龈出血、白内障(视力逐渐模糊)?肝功能异常、颅内压增高(表现为严重头痛、视力减退、复视、呕吐)?白细胞增多症、急性胰腺炎、多发性神经炎等。|3.罕见的不良反应有:|女性阴蒂增大、男性睾丸缩小。肝脏功能损害严重时,男女均可出现巩膜或皮肤黄染。|4.以下反应如果持续出现需引起注意 |(1)由于雌激素效能低下,可使妇女有阴道灼热、干枯及瘙痒,或阴道出血。 |(2)可出现皮肤发红、情绪或精神状态的改变、神经质或多汗。 |(3)有时可出现肌痉挛性疼痛,属于肌肉中毒症状。

禁忌

血栓病患者、心肝肾疾患者、异常性生殖器出血患者禁用。

注意事项

1.癫痫、偏头痛、糖尿病患者慎用。|2.治疗期间注意肝功能检查。男性用药时,需检查精液量、粘度、精子数和活动力,每3~4月检查一次,特别是青年患者。|3.女性开始时,应采取工具避孕,防止妊娠;一旦发生妊娠,立即停药并终止妊娠。|4.服药期间对一些诊断性实验有影响。如糖耐量试验、甲状腺功能试验、血清总T4可降低而血清T3则可增加。|5.使用本品时应注意有无心脏功能损害、肾脏功能损害、生殖器官出血及肝脏功能损害,对男性应注意睾丸大小。|6.出现男性化症状,应停止治疗。

贮藏

遮光,密封保存。

规格

100mg*30粒/盒

证据Evidence

  • 批准文号: 国药准字H20023742
  • 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.