Tian Kai (天凯)天凯

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

罗红霉素是一种在国家药监局注册认定的药品。该药品含有罗红霉素-73533932等成分。

该药品关联的活性成分包括:罗红霉素Luohong Meisu。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:新华制药(高密)有限公司Chinese legal name: 新华制药(高密有限公司)。

您可以探索含有相同成分的其他药品:罗红霉素-73533932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: 天凯) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: 罗红霉素Luohong Meisu.

Manufacturers recorded for this product: 新华制药(高密)有限公司Chinese legal name: 新华制药(高密有限公司).

Explore other medicines containing the same ingredient: 罗红霉素 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: 天凯Recorded Chinese name: 天凯
  • 剂型Dosage form: 干混悬剂Powder for oral suspension
  • 规格Specification: 50mg50 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

  • 新华制药(高密)有限公司Chinese legal name: 新华制药(高密有限公司)

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H19990013

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H19990013

Manufacturer

Chinese legal name: 新华制药(高密)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H19990013

生产企业

新华制药(高密)有限公司(国产)

适应症

1.适应于敏感菌株引起的下列感染:上呼吸道感染,下呼吸道感染,耳鼻喉感染, 生殖器感染(淋球菌感染除外),皮肤软组织感染。 2.也可用于支原体肺炎、沙眼衣原体感染及军团病等。

用法用量

1.口服,成人每日1.6g,分2或4次服用,军团菌病宜用较大量,每次0.8一1.6g,一日4次,成人每日量一般不宜超过4g。 2.小儿: (1)每日4次,每次按体重口服7.5一12.5mg/kg;或每日2次,每次15―25mg/kg,严重感染时每日量可加倍,分4次服。 (2)百日咳患儿每次口服10一12.5mg/kg,一日4次,疗程14天。

不良反应

1.可见胃肠道反应:恶心、呕吐、畏食、腹痛。
2.可见肝功能异常:丙氨酸氨基转移酶(ALT)及天门冬氨酸氨基转移酶(AST)升高。
3.可见皮疹。

禁忌

1.对本品过敏者禁用。
2.禁忌与麦角胺及二氢麦角胺配伍。

注意事项

1.肝功能不全者慎用。
2.肾功能不全者可发生累积效应。
3.使用本品可引起非敏感菌的过度增殖,引发二重感染。

贮藏

密封,在凉暗干燥处保存。

规格

50mg

证据Evidence

  • 批准文号: 国药准字H19990013
  • 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.