Recorded Chinese product: 注射用乳糖酸红霉素注射用乳糖酸红霉素
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
- 江西赣南海欣药业股份有限公司Chinese legal name: 江西赣南海欣药业股份有限公司
主要成分Active Ingredients
- 红霉素Hongmei Su
药物知识说明
红霉素是一种在国家药监局注册认定的药品。该药品含有红霉素-70dce127等成分。
该药品关联的活性成分包括：红霉素Hongmei Su。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：江西赣南海欣药业股份有限公司Chinese legal name: 江西赣南海欣药业股份有限公司。
您可以探索含有相同成分的其他药品：红霉素-70dce127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: 注射用乳糖酸红霉素) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 红霉素Hongmei Su.
Manufacturers recorded for this product: 江西赣南海欣药业股份有限公司Chinese legal name: 江西赣南海欣药业股份有限公司.
Explore other medicines containing the same ingredient: 红霉素 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: 注射用乳糖酸红霉素Recorded Chinese product: 注射用乳糖酸红霉素
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 按红霉素计0.3g(30万单位)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
- 江西赣南海欣药业股份有限公司Chinese legal name: 江西赣南海欣药业股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H36021155
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H36021155
Manufacturer
Chinese legal name: 江西赣南海欣药业股份有限公司 (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H36021155
生产企业
江西赣南海欣药业股份有限公司(国产)
适应症
本品作为青霉素过敏患者治疗下列感染的替代用药：|1.溶血性链球菌、肺炎链球菌等所致的急性扁桃体炎、急性咽炎、鼻窦炎。|2.溶血性链球菌所致的猩红热、蜂窝织炎、白喉及白喉带菌者、气性坏疽、炭疽、破伤风、放线菌病、梅毒、单核细胞增多性李斯特菌病等。|3.军团菌病，支原体肺炎，衣原体肺炎，其他衣原体属、支原体属所致泌尿生殖系感染。|4.沙眼衣原体结膜炎，厌氧菌所致口腔感染，空肠弯曲菌肠炎，百日咳。
用法用量
1.静脉滴注：成人一次0.5～1.0g，一日2～3次，治疗军团菌病剂量需增加至一日3～4g，分4次滴注，小儿每日按体重20～30mg/kg，分2～3次滴注。2.乳糖酸红霉素滴注液的配制：|(1)先加灭菌注射用水10ml至0.5g乳糖酸红霉素粉针瓶中或加20ml至1g乳糖酸红霉素粉针瓶中，用力震摇至溶解。|(2)然后加入生理盐水或其它电解质溶液中稀释，缓慢静脉滴注，注意红霉素浓度在1%～5%以内。|(3)溶解后也可加入含葡萄糖的溶液稀释，但因葡萄糖溶液偏酸性，必须每100ml溶液中加入4%碳酸氢钠1ml。
不良反应
1.胃肠道反应多见，有腹泻、恶心、呕吐、中上腹痛、口舌疼痛、胃纳减退等，其发生率与剂量大小有关。|2.肝毒性少见，患者可有乏力、恶心、呕吐、腹痛、发热及肝功能异常，偶见黄疸等。|3.大剂量(≥4g/日)应用时，尤其肝、肾疾病患者或老年患者，可能引起听力减退，主要与血药浓度过高(>12mg/L)有关，停药后大多可恢复。|4.过敏反应表现为药物热、皮疹、嗜酸粒细胞增多等，发生率约0.5%～1%。|5.其他：偶有心律失常、口腔或阴道念珠菌感染。
禁忌
对红霉素类药物过敏者禁用。
注意事项
1.溶血性链球菌感染用本品治疗时，至少需持续10日，以防止急性风湿热的发生。|2.肾功能减退患者一般无需减少用量。|3.用药期间定期随访肝功能。肝病患者和严重肾功能损害者红霉素的剂量应适当减少。|4.患者对一种红霉素制剂过敏或不能耐受时，对其他红霉素制剂也可过敏或不能耐受。|5.对诊断的干扰：本品可干扰Higerty法的荧光测定，使尿儿茶酚胺的测定值出现假性增高，血清碱性磷酸酶、胆红素、丙氨酸氨基转移酶和门冬氨酸氨基转移酶的测定值均可能增高。|6.因不同细菌对红霉素的敏感性存在一定差异，故应做药敏测定。
贮藏
密闭
规格
按红霉素计0.3g(30万单位)
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.