Ji Di (济迪)济迪

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

索他洛尔是一种在国家药监局注册认定的药品。该药品含有索他洛尔-8e94377b等成分。

该药品关联的活性成分包括：索他洛尔Suota Luoer。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：山东罗欣药业集团股份有限公司Chinese legal name: 山东罗欣药业集团股份有限公司。

您可以探索含有相同成分的其他药品：索他洛尔-8e94377b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: 济迪) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: 索他洛尔Suota Luoer.

Manufacturers recorded for this product: 山东罗欣药业集团股份有限公司Chinese legal name: 山东罗欣药业集团股份有限公司.

Explore other medicines containing the same ingredient: 索他洛尔 productsProducts containing this recorded ingredient.

Source: MedicineGraph authoritative database. Relationships derived from registered product information.

Same active ingredient相同活性成分

Manufacturer recorded for this product本页记录的生产企业

这是什么What is this

  • 通用名/品名Recorded product name: 济迪Recorded Chinese name: 济迪
  • 剂型Dosage form: 片剂Tablets
  • 规格Specification: 40mg40 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

Same active ingredient相同活性成分

生产企业Manufacturer

  • 山东罗欣药业集团股份有限公司Chinese legal name: 山东罗欣药业集团股份有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H19991061

关联实体Relationships

Products by this manufacturer该企业已记录的药品

相关问题Questions

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H19991061

Manufacturer

Chinese legal name: 山东罗欣药业集团股份有限公司 (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

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H19991061

生产企业

山东罗欣药业集团股份有限公司(国产)

适应症

1.转复，预防室上性心动过速，特别是房室结折返性心动过速也可用于予激综合征伴室上性心动过速。|2.心房扑动，心房颤动。|3.各种室性心律失常，包括室性早搏，持续性及非持续性室性心动过速。|4.急性心肌梗死并发严重心律失常。

用法用量

1.口服给药: 1. 80～160mg/日，分二次服用，从小剂量开始，逐渐加量。|2.室性心动过速成可160～480mg/日。|3.肾功能不全应减少剂量。

不良反应

1.与β-受体阻滞剂作用相关的有心动过缓、低血压、支气管痉挛.|2.本品高可有乏力、气短眩晕、恶心、呕吐皮疹等. |3.本品严重的不良反应是致心律失常作用，可表现为原有心律失常加重或出现新的心律失常，严重时可出现扭转性室性心动过速，多源性室必心动过速，心室颤动，多与剂量大，低钾，Q-T延长，严重心脏病变等有关.

禁忌

1.心动过缓，心率<60次/分病态窦房结综合征，Ⅱ-Ⅲ度房室传导阻滞，室内传导阻滞，低血压、休克、Q-T延长。|2.未控制心衰及过敏者。

注意事项

1.用药前及用药过程要查电解质，注意有无低钾、低镁，需及时纠正。|2.用药过程需注意心率及血压变化。|3.应监测心电图QTc变化，QTc>500ms应停药。|4.肾功能不全，需慎用或减量。|5.孕妇，哺乳妇女慎用。

贮藏

遮光，密闭保存。

规格

40mg

证据Evidence

  • 批准文号: 国药准字H19991061
  • 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.