Recorded Chinese product: 奥美拉唑微丸奥美拉唑微丸

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

奥美拉唑是一种在国家药监局注册认定的药品。该药品含有奥美拉唑-c19b3edf等成分。

该药品关联的活性成分包括:奥美拉唑omeprazole。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:广东彼迪药业有限公司Chinese legal name: 广东彼迪药业有限公司。

您可以探索含有相同成分的其他药品:奥美拉唑-c19b3edf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

omeprazole is a medicine registered with the national drug regulatory authority. It contains omeprazole as active ingredient(s).

Active ingredients associated with this product: omeprazoleomeprazole.

Manufacturers recorded for this product: 广东彼迪药业有限公司Chinese legal name: 广东彼迪药业有限公司.

Explore other medicines containing the same ingredient: omeprazole products.

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: 奥美拉唑微丸Recorded Chinese product: 奥美拉唑微丸
  • 剂型Dosage form: 丸剂Pills
  • 规格Specification: 每克含奥美拉唑85mgEach gram contains omeprazole 85 mg

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

  • 广东彼迪药业有限公司Chinese legal name: 广东彼迪药业有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H20057363

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H20057363

Manufacturer

Chinese legal name: 广东彼迪药业有限公司 (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

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H20057363

生产企业

广东彼迪药业有限公司(国产)

适应症

适用于胃溃疡、十二指肠溃疡、应激性溃疡、反流性食管炎和卓-艾综合征(胃泌素瘤)。

用法用量

口服。|1.治疗十二指肠溃疡,1次/日,20mg/次,疗程2~4周。|2.治疗-艾综合征,初始剂量为1次/日,60mg/次。90%以上患者用20~120mg/日即可控制症状。如剂量大于80mg/日,则应分2次给药。|3.治疗反流性食管炎剂量为20~60mg/日。

不良反应

主要为恶心、胀气、腹泻、便秘、上腹痛等。皮疹、ALT和胆红素升高也有发生,一般是轻微和短暂的,大多不影响治疗。

禁忌

1.对本品过敏者、严重肾功能不全者及婴幼儿禁用。|2.严重肝功能不全者慎用,必要时剂量减半。

注意事项

本品具有酶抑制作用,一些经肝脏细胞色素P450系统代谢的药物,如双香豆素、地西泮、苯妥英钠等,其t1/2可因合用本品而延长。

贮藏

密封保存。

规格

每克含奥美拉唑85mg

证据Evidence

  • 批准文号: 国药准字H20057363
  • 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.