Recorded Chinese product: 硫酸妥布霉素氯化钠注射液硫酸妥布霉素氯化钠注射液
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H20010559
生产企业Manufacturer
- 江苏苏中药业集团股份有限公司Chinese legal name: 江苏苏中药业集团股份有限公司
主要成分Active Ingredients
- 妥布霉素Tuobu Meisu
药物知识说明
国药准字H20010559是一种在国家药监局注册认定的药品。该药品含有妥布霉素-51a90030等成分。
该药品关联的活性成分包括：妥布霉素Tuobu Meisu。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：江苏苏中药业集团股份有限公司Chinese legal name: 江苏苏中药业集团股份有限公司。
您可以探索含有相同成分的其他药品：妥布霉素-51a90030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: 硫酸妥布霉素氯化钠注射液) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 妥布霉素Tuobu Meisu.
Manufacturers recorded for this product: 江苏苏中药业集团股份有限公司Chinese legal name: 江苏苏中药业集团股份有限公司.
Explore other medicines containing the same ingredient: 妥布霉素 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: 硫酸妥布霉素氯化钠注射液Recorded Chinese product: 硫酸妥布霉素氯化钠注射液
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 100ml:妥布霉素80mg(8万单位):氯化钠0.9gRecorded Chinese specification: 100ml:妥布霉素80mg(8万单位):氯化钠0.9g
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
- 江苏苏中药业集团股份有限公司Chinese legal name: 江苏苏中药业集团股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20010559
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H20010559
Manufacturer
Chinese legal name: 江苏苏中药业集团股份有限公司 (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H20010559
生产企业
江苏苏中药业集团股份有限公司(国产)
适应症
适用于鼻窦炎,皮肤软组织感染,中耳炎,烧伤等。
用法用量
1.静脉滴注。在疗程中宜定期测定患者的血峰、谷浓度、并按此调整剂量。处理严重感染时宜给予首次冲击量，以保证药物在组织和体液中迅速达到有效浓度，剂量应按标准体重（去除过多脂肪）计算。 2.本品可股内注射或静肪注射，7～10天为一疗程： (1)肾功能正常的病人用药量按体重一日2～3mg/kg，分2～4次给药，严重感染病人按体重日4～5mg/kg，临床症状改善后应降至每日3mg/kg。 (2)婴儿和儿童用药量为每日3～5mg/kg，肾功能障碍或老年病人，需减少首剂用药量或延长给药间隔。静滴给药时，可取本品80mg用5%葡萄糖或生理盐水稀释至50或100ml后，在20～60分钟内滴完，间隔时间为6～8小时。
不良反应
不良反应主要是对第八对脑神经及肾脏有毒性，可有听力减退、头昏、眩晕、耳鸣等，以及蛋白尿、管型尿、血尿素氮和血肌酐升高等肾损伤症状。
禁忌
对本品及其他氨基糖苷类药物过敏者禁用。
注意事项
对本品过敏者禁用，过敏体质者慎用。
贮藏
遮光、密闭保存
规格
100ml:妥布霉素80mg(8万单位):氯化钠0.9g
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.