Sulbactam Sodium for Injection (注射用舒巴坦钠)注射用舒巴坦钠
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
- 海南卫康制药(潜山)有限公司Chinese legal name: 海南卫康制药(潜山有限公司)
主要成分Active Ingredients
- 舒巴坦钠Shuba Tanna
药物知识说明
舒巴坦钠是一种在国家药监局注册认定的药品。该药品含有舒巴坦钠-35399356等成分。
该药品关联的活性成分包括：舒巴坦钠Shuba Tanna。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：海南卫康制药(潜山)有限公司Chinese legal name: 海南卫康制药(潜山有限公司)。
您可以探索含有相同成分的其他药品：舒巴坦钠-35399356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: 注射用舒巴坦钠) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 舒巴坦钠Shuba Tanna.
Manufacturers recorded for this product: 海南卫康制药(潜山)有限公司Chinese legal name: 海南卫康制药(潜山有限公司).
Explore other medicines containing the same ingredient: 舒巴坦钠 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: 注射用舒巴坦钠Sulbactam Sodium for Injection (注射用舒巴坦钠)
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 0.5g瓶/支Recorded 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
- 海南卫康制药(潜山)有限公司Chinese legal name: 海南卫康制药(潜山有限公司)
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20055461
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H20055461
Manufacturer
Chinese legal name: 海南卫康制药(潜山)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.
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H20055461
生产企业
海南卫康制药(潜山)有限公司(国产)
适应症
本品与青霉素类或头孢菌素类联合，用于治疗敏感菌所致的尿路感染、肺部感染、支气管感染、耳鼻喉科感染、腹腔和盆腔感染、胆道感染、败血症、皮肤软组织感染等。
用法用量
该品与氨苄西林以1：2剂量比应用：|1.一般感染，成人剂量为一日舒巴坦1～2g，氨苄西林2～4g，分2～3次静脉滴注或肌内注射。|2.轻度感染，亦可一日舒巴坦0.5g，氨苄西林1g，分2次静脉滴注或肌内注射。|3.重度感染，可增大剂量至一日舒巴坦3～4g，氨苄西林6～8g，分3～4次静脉滴注。
不良反应
该品与氨苄西林联合应用，不良反应发生率约10%以下，中止治疗者仅0.7%：|1.注射部位疼痛3.6%，静脉炎、腹泻、恶心等反应偶有发生，皮疹发生率1%～6%。|2.偶见一过性嗜酸性粒细胞增多、血清氨基转移酶升高等。|3.极个别病例发生剥脱性皮炎、过敏性休克。
禁忌
对青霉素类药物过敏者禁用。
注意事项
1.该品必须和内酰胺类抗生素合用，单独使用无效。|2.用药前须做青霉素皮肤试验，阳性者禁用。|3.交叉过敏反应：对一种青霉素类抗生素过敏者可能对其他青霉素类抗生素也过敏。|4.肾功能减退者，根据血浆肌酐清除率调整用药：血浆肌酐清除率（ml/分钟）半衰期（小时）给药间期（小时）≥3016～815～295125～14924。|5.该品配成溶液后必须及时使用，不宜久置。|6.对诊断的干扰：|(1)用药期间，以硫酸铜法进行尿糖测定时可出现假阳性，用葡萄糖酶法者则不受影响。|(2)大剂量注射给药可出现高钠血症。|(3)可使血清丙氨酸氨基转移酶或门冬氨酸氨基转移酶升高。|7.应用大剂量时应定期检测血清钠。
规格
0.5g瓶/支
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.