Adsorbed Acellular Diphtheria, Tetanus and Pertussis Combined Vaccine吸附无细胞百白破联合疫苗

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

破伤风类毒素是一种在国家药监局注册认定的药品。该药品含有pt被不可逆转地脱毒、成品疫苗用生理盐水配制、破伤风毒素经脱毒-0cb85d35等成分。

该药品关联的活性成分包括:pt被不可逆转地脱毒、成品疫苗用生理盐水配制、破伤风毒素经脱毒、破伤风类毒素是由白喉毒素Poshang Fenglei Dusu Shiyou Baihou Dusu、经氢氧化铝吸附而成Jingqing Yanghua Lvxi Fuer Cheng。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:武汉生物制品研究所有限责任公司Chinese legal name: 武汉生物制品研究所有限责任公司。

您可以探索含有相同成分的其他药品:pt被不可逆转地脱毒-a4da8940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: 吸附无细胞百白破联合疫苗) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: pt, 破伤风类毒素是由白喉毒素Poshang Fenglei Dusu Shiyou Baihou Dusu, 经氢氧化铝吸附而成Jingqing Yanghua Lvxi Fuer Cheng.

Manufacturers recorded for this product: 武汉生物制品研究所有限责任公司Chinese legal name: 武汉生物制品研究所有限责任公司.

Explore other medicines containing the same ingredient: pt被不可逆转地脱毒 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: 吸附无细胞百白破联合疫苗Adsorbed Acellular Diphtheria, Tetanus and Pertussis Combined Vaccine
  • 规格Specification: 每安瓿2.0ml。每1次人用剂量0.5ml,含无细胞百日咳疫苗效价不低于4.0IU,白喉疫苗效价不低于30IU,破伤风疫苗效价不低于40IU。Recorded Chinese description: 每安瓿2.0ml。每1次人用剂量0.5ml,含无细胞百日咳疫苗效价不低于4.0IU,白喉疫苗效价不低于30IU,破伤风疫苗效价不低于40IU。

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

  • 武汉生物制品研究所有限责任公司Chinese legal name: 武汉生物制品研究所有限责任公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字S19980015

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S19980015

Manufacturer

Chinese legal name: 武汉生物制品研究所有限责任公司 (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.

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S19980015

生产企业

武汉生物制品研究所有限责任公司(国产)

适应症

本疫苗接种后,可使机体产生免疫应答,用于预防百日咳、白喉、破伤风。

用法用量

1. 臀部外上方1/4处或上臂外侧三角肌附着处皮肤经消毒后肌内注射。2. 免疫程序与剂量。基础免疫自3月龄开始,至12月龄完成3针免疫,每次0.5ml,每针间隔4~6周。加强免疫通常在基础免疫后18~24月龄内进行,注射剂量为0.5ml。

不良反应

注射本品一般无反应,有的接种部位有轻度红晕、痒感或有低热,一般不须特殊处理,即行消退,如有严重反应及时诊治。

禁忌

1. 有癫痫、神经系统疾病及抽风史者禁用。2. 急性传染病(包括恢复期)及发热者,暂缓注射。

注意事项

1. 使用时应充分摇匀,如出现摇不散之凝块、有异物、安瓿有裂纹、制品曾经冻结、标签不清和过期失效者不可使用。2. 注射后局部可能有硬结,可逐步吸收。注射第2针时应更换另侧部位。 3. 应备肾上腺素,供偶有发生休克时急救用。4. 注射第1针后出现高热、惊厥等异常情况者,不再注射第2针。

规格

每安瓿2.0ml。每1次人用剂量0.5ml,含无细胞百日咳疫苗效价不低于4.0IU,白喉疫苗效价不低于30IU,破伤风疫苗效价不低于40IU。

证据Evidence

  • 批准文号: 国药准字S19980015
  • 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.