Rubella Live Attenuated Vaccine (Human Diploid Cell)风疹减毒活疫苗(人二倍体细胞)

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

风疹减毒活病毒是一种在国家药监局注册认定的药品。标注生产企业为北京天坛生物制品股份有限公司。

该药品暂无关联的活性成分信息。

该药品标注的生产企业为:北京天坛生物制品股份有限公司Chinese legal name: 北京天坛生物制品股份有限公司、北京天坛生物制品股份有限公司Chinese legal name: 北京天坛生物制品股份有限公司、北京天坛生物制品股份有限公司Chinese legal name: 北京天坛生物制品股份有限公司。

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: 风疹减毒活疫苗(人二倍体细胞)) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 北京天坛生物制品股份有限公司.

No active ingredient relationships are currently recorded for this product in MedicineGraph.

Manufacturers recorded for this product: 北京天坛生物制品股份有限公司Chinese legal name: 北京天坛生物制品股份有限公司, 北京天坛生物制品股份有限公司Chinese legal name: 北京天坛生物制品股份有限公司, 北京天坛生物制品股份有限公司Chinese legal name: 北京天坛生物制品股份有限公司.

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: 风疹减毒活疫苗(人二倍体细胞)Rubella Live Attenuated Vaccine (Human Diploid Cell)
  • 规格Specification: 复溶后每瓶0.5ml。Recorded Chinese description: 复溶后每瓶0.5ml。

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.

生产企业Manufacturer

  • 北京天坛生物制品股份有限公司Chinese legal name: 北京天坛生物制品股份有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字S10980008

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)

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S10980008

Manufacturer

Chinese legal name: 北京天坛生物制品股份有限公司 (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S10980008

生产企业

北京天坛生物制品股份有限公司(国产)

适应症

8月龄以上的风疹易感者。

用法用量

(1)按每瓶0.5ml加入灭菌注射用水,待疫苗溶解并摇匀后使用。

(2)于上臂外侧三角肌下缘附着处皮下注射0.5ml。

不良反应

注射后一般无局部反应。在6~11天内,个别人可能出现一过性发热反应及轻微皮疹,一般不超过2天可自行缓解;成人接种后2~4周内,个别人可能出现轻度关节反应,一般不需要特殊处理,必要时可对症治疗。

禁忌

(1)患严重疾病、发热者。


(2)有过敏史者。


(3)妊娠期妇女。

注意事项

(1)开启疫苗瓶和注射时,切勿使消毒剂接触疫苗。

贮藏

于8℃以下避光保存和运输。

规格

复溶后每瓶0.5ml。

证据Evidence

  • 批准文号: 国药准字S10980008
  • 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.