Recorded Chinese product: 注射用盐酸氨溴索注射用盐酸氨溴索
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
- 氨溴索Anxiu Suo
药物知识说明
氨溴索是一种在国家药监局注册认定的药品。该药品含有氨溴索-e92651e5等成分。
该药品关联的活性成分包括：氨溴索Anxiu Suo。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：氨溴索-e92651e5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: 注射用盐酸氨溴索) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 氨溴索Anxiu Suo.
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: 氨溴索 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: 注射用盐酸氨溴索Recorded Chinese product: 注射用盐酸氨溴索
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 30mg30 mg
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H20090230
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H20090230
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.
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H20090230
生产企业
海南卫康制药(潜山)有限公司(国产)
适应症
本品适用于伴有痰液分泌不正常及排痰功能不良的急性、慢性呼吸道疾病.例如慢性支气管炎急性加重、喘息型支气管炎、支气管扩张及支气管哮喘的祛痰治疗。术后肺部并发症的预防性治疗。早产儿及新生儿婴儿呼吸窘迫综合征(IRDS)的治疗。
用法用量
用前用5ml无菌注射用水溶解，缓慢静脉注射。成人及12岁以上儿童：每天2次，每次30mg。本品亦可用适量无菌注射用水稀释后与葡萄糖、果糖、0.9%氯化钠注射液或林格氏液混合静脉点滴使用。预防治疗：成人及12岁以上儿童：每天2-3次，每次15mg，严重病例可以增至每次30mg；6-12岁儿童：每天2-3次，每次15mg；2-6岁儿童：每天3次，每次7.5mg；2岁以下儿童：每天2次，每次7.5mg；均为缓慢静脉注射。婴儿呼吸窘迫综合征(1RDS)的治疗：每日用药总重以婴儿体重计算30mg/kg，分4次给药，应使用注射泵给药。静脉注射时间至少5分钟。
不良反应
本品通常能很好耐受，曾有轻度的胃肠道不良反应报道．主要为胃部灼热、消化不良和偶尔出现恶心、呕吐。过敏反应极少出现，主要为皮疹。极少病例出现严重的急性过敏性反应，但其与盐酸氨溴索的相关性尚不能肯定，这类病人通常对其他物质亦产生过敏。快速静注可引起头痛、腿痛和疲惫感。
禁忌
本品已知对盐酸氨溴索或其它配方成份过敏者禁用。
注意事项
本品用无菌注射用水溶解后pH5.0．不能与pH大于6.3的其它溶液混合。因为pH值增加会导致产生氨滇索游离碱沉淀。
贮藏
密闭
规格
30mg
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.