An Xin (安信)安信

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

比阿培南是一种在国家药监局注册认定的药品。标注生产企业为南京先声东元制药有限公司。

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:南京先声东元制药有限公司Chinese legal name: 南京先声东元制药有限公司、南京先声东元制药有限公司Chinese legal name: 南京先声东元制药有限公司、南京先声东元制药有限公司Chinese legal name: 南京先声东元制药有限公司。

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: 安信) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 南京先声东元制药有限公司.

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

Manufacturers recorded for this product: 南京先声东元制药有限公司Chinese legal name: 南京先声东元制药有限公司, 南京先声东元制药有限公司Chinese legal name: 南京先声东元制药有限公司, 南京先声东元制药有限公司Chinese legal name: 南京先声东元制药有限公司.

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: 安信Recorded Chinese name: 安信
  • 剂型Dosage form: 注射剂Injection
  • 规格Specification: 0.3g。0.3 g

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

  • 南京先声东元制药有限公司Chinese legal name: 南京先声东元制药有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H20080225

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H20080225

Manufacturer

Chinese legal name: 南京先声东元制药有限公司 (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H20080225

生产企业

南京先声东元制药有限公司(国产)

适应症

本品适用于治疗由敏感细菌所引起的败血症、肺炎、肺部脓肿、慢性呼吸道疾病引起的二次感染、难治性膀胱炎、肾盂肾炎、腹膜炎、妇科附件炎等。

用法用量

1.每0.3g比阿培南溶解于100ml生理盐水或葡萄糖注射液中静脉滴注。|2.成人每日0.6g,分2次滴注,每次30~60分钟。|3.可根据患者年龄、症状适当增减给药剂量,但1天的最大给药量不得超过1.2g。

不良反应

1.国外文献报道,最为常见的不良反应为皮疹/皮肤瘙痒、恶心、呕吐以及腹泻等。|2.在2348个病例中,有64例(2.7%)出现不良反应,主要表现为皮疹(1.0%)、腹泻(0.7%)等。|3.在2287个病例中,有304例(13.3%)的522个临床检测指标异常,主要表现为ALT(GPT)上升(144例,6.3%),AST(GOT)上升(93例,4.1%),嗜酸性粒细胞增多(77例,3.4%)等。|4.该品严重不良反应包括:休克(<0.1%)、过敏,间质性肺炎(0.1%-5%),PIE综合症,伪膜性结肠炎等严重肠炎,肌痉挛、精神障碍,肝功能损伤、黄疸,急性肾功能不全。

禁忌

1.对本品过敏者禁用。|2.正在服用丙戊酸钠类药物的患者禁用。

注意事项

1.对碳青霉烯类、青霉素类及头孢类抗生素药物过敏者慎用。|2.本人或直系亲属有易诱发支气管哮喘、皮疹、荨麻疹等症状的过敏性体质者慎用。|3.严重的肾功能不全者慎用。|4.老年患者慎用(参照【老年用药】)。|5.进食困难及全身状况恶化者,可能会出现维生素K缺乏症状,应注意观察。|6.有癫痫史者或中枢神经系统疾病患者慎用。|7.除尿潜血反应外,采用班氏试剂、斐林试剂以及试纸法检测尿糖可能出现假阳性结果。|8.直接库姆斯试验可能呈现阳性结果。

贮藏

遮光,密封保存。

规格

0.3g。

证据Evidence

  • 批准文号: 国药准字H20080225
  • 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.