Amoxicillin Sodium for Injection (注射用阿莫西林钠)注射用阿莫西林钠

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。

批准文号:NMPA approval number: 国药准字H20003028

生产企业Manufacturer

主要成分Active Ingredients

药物知识说明

国药准字H20003028是一种在国家药监局注册认定的药品。该药品含有阿莫西林钠-565ea081等成分。

该药品关联的活性成分包括：阿莫西林钠Amo Xilin 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：山东鲁抗医药股份有限公司Chinese legal name: 山东鲁抗医药股份有限公司。

您可以探索含有相同成分的其他药品：阿莫西林钠-565ea081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: 注射用阿莫西林钠) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: 阿莫西林钠Amo Xilin Na.

Manufacturers recorded for this product: 山东鲁抗医药股份有限公司Chinese legal name: 山东鲁抗医药股份有限公司.

Explore other medicines containing the same ingredient: 阿莫西林钠 productsProducts containing this recorded ingredient.

Source: MedicineGraph authoritative database. Relationships derived from registered product information.

Same active ingredient相同活性成分

Manufacturer recorded for this product本页记录的生产企业

这是什么What is this

  • 通用名/品名Recorded product name: 注射用阿莫西林钠Amoxicillin Sodium for Injection (注射用阿莫西林钠)
  • 剂型Dosage form: 注射剂Injection
  • 规格Specification: 玻璃瓶,0.5g×50支。Recorded Chinese description: 玻璃瓶,0.5g×50支。

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

Same active ingredient相同活性成分

生产企业Manufacturer

  • 山东鲁抗医药股份有限公司Chinese legal name: 山东鲁抗医药股份有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H20003028

关联实体Relationships

Products by this manufacturer该企业已记录的药品

相关问题Questions

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H20003028

Manufacturer

Chinese legal name: 山东鲁抗医药股份有限公司 (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

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H20003028

生产企业

山东鲁抗医药股份有限公司(国产)

适应症

本品适用于敏感菌(不产β内酰胺酶菌株)所致下列感染中病情较重需要住院治疗或不能口服的患者。|1.溶血链球菌、肺炎链球菌、葡萄球菌或流感嗜血杆菌所致中耳炎、鼻窦炎、咽炎、扁桃体炎等上呼吸道感染。|2.大肠埃希菌、奇异变形杆菌或粪肠球菌所致的泌尿生殖道感染。|3.溶血链球菌、葡萄球菌或大肠埃希菌所致的皮肤软组织感染。|4.溶血链球菌、肺炎链球菌、葡萄球菌或流感嗜血杆菌所致急性支气管炎、肺炎等下呼吸道感染。|5.本品尚可用于治疗伤寒及钩端螺旋体病。

用法用量

肌内注射或稀释后静脉滴注给药。|1.成人一次0.5～1g，每6～8小时1次。|2.小儿一日剂量按体重50～100mg/kg，分3～4次给药。肾功能严重损害患者需调整给药剂量，其中内生肌酐清除率为10～30ml/分钟的患者每12小时0.25～0.5g;内生肌酐清除率小于10ml/分钟的患者每24小时0.2.～0.5g。血液透析可清除本品，每次血液透析后应给予阿莫西林1g。

不良反应

1.恶心、呕吐、腹泻及假膜性肠炎等胃肠道反应。|2.皮疹、药物热和哮喘等过敏反应。|3.贫血、血小板减少、嗜酸性粒细胞增多等。|4.血清氨基转移酶可轻度增高。|5.由念珠菌或耐药菌引起的二重感染。|6.偶见兴奋、焦虑、失眠、头晕及行为异常等中枢神经系统症状。

禁忌

青霉素过敏及青霉素皮肤试验阳性患者禁用。

注意事项

1.青霉素类药物偶可致过敏性休克，尤多见于有青霉素或头孢菌素过敏史的患者。用药前必须详细询问药物过敏史并作青霉素皮肤试验。如发生过敏性休克，应就地抢救，予以保持气道畅通、吸氧及应用肾上腺素、糖皮质激素等治疗措施。|2.传染性单核细胞增多症患者应用本品易发生皮疹，应避免使用。|3.疗程较长患者应检查肝、肾功能和血常规。|4.阿莫西林可导致采用Benedict或Fehling试剂的尿糖试验出现假阳性。|5.下列情况应慎用：|(1)有哮喘、湿疹、枯草热、荨麻疹等过敏性疾病史者。|(2)老年人和肾功能严重损害时可能须调整剂量。

贮藏

遮光，密闭保存。

规格

玻璃瓶,0.5g×50支。

证据Evidence

  • 批准文号: 国药准字H20003028
  • 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.