Recorded Chinese product: 注射用头孢尼西钠注射用头孢尼西钠

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

头孢尼西钠是一种在国家药监局注册认定的药品。该药品含有头孢尼西钠-f9527753等成分。

该药品关联的活性成分包括:头孢尼西钠Toubao Nixi Na。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:深圳致君制药有限公司Chinese legal name: 深圳致君制药有限公司。

您可以探索含有相同成分的其他药品:头孢尼西钠-f9527753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: 注射用头孢尼西钠) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: 头孢尼西钠Toubao Nixi Na.

Manufacturers recorded for this product: 深圳致君制药有限公司Chinese legal name: 深圳致君制药有限公司.

Explore other medicines containing the same ingredient: 头孢尼西钠 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: 注射用头孢尼西钠Recorded Chinese product: 注射用头孢尼西钠
  • 剂型Dosage form: 注射剂Injection
  • 规格Specification: 按C18H18N6O8S3计算1.0gRecorded Chinese specification

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

  • 深圳致君制药有限公司Chinese legal name: 深圳致君制药有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H20083705

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H20083705

Manufacturer

Chinese legal name: 深圳致君制药有限公司 (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.

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H20083705

生产企业

深圳致君制药有限公司(国产)

适应症

本品主要适用于敏感菌引起的下列感染:下呼吸道感染、尿路感染、败血症、皮肤软组织感染、骨和关节感染,也可用于手术预防感染。

用法用量

1.肌肉注射、静脉注射或静脉滴注:成人一般每日0.5g-1.0g, 分1-2次。|2.对重症、难治感染,成人可增至每日2g,儿童根据感染程度,每日25mg-150mg/kg。

不良反应

头孢尼西钠通常耐受较好,最常见的不良反应为肌肉注射时的疼痛感。发生率大于1%的不良反应有。注射部位反应:疼痛不适,静脉注射部位烧灼感、静脉炎。血液系统:血小板增加,嗜酸性粒细胞增多。肝功能实验室检查异常:碱性磷酸酶增加、血清转氨酶(ALT、AST)增加、乳酸脱氢酶(LDH)增加,谷氨酰胺转肽酶(GGTP)增加。发生率小于1%的不良反应有。过敏反应:发热、皮疹、荨麻疹、瘙痒、红斑、肌痛、变态反应、Stevens-Johnson综合症等。胃肠道:恶心、呕吐、腹泻、伪膜性结肠炎。血液系统:白细胞减少、中性粒细胞减少、血小板减少、溶血性贫血、Coombs’试验阳性。肾毒性:偶见血尿素氮、肌酐值升高,间质性肾炎,少有急性肾衰的报道。中枢神经:抽搐(大剂量或肾功能障碍时)、头痛、精神紧张。神经肌肉骨骼:关节疼痛。其他:念珠菌病。

禁忌

尚不明确。

贮藏

遮光,密封,在阴凉干燥处(不超过 20℃)保存。

规格

按C18H18N6O8S3计算1.0g

证据Evidence

  • 批准文号: 国药准字H20083705
  • 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.