Hepatitis A Inactivated Vaccine (Vero Cell)甲型肝炎灭活疫苗(Vero细胞)
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S20090006
生产企业Manufacturer
- 上海泽润生物科技有限公司Chinese legal name: 上海泽润生物科技有限公司
主要成分Active Ingredients
- 甲型肝炎灭活病毒Jiaxing Ganyan Miehuo Bingdu
- 氢氧化铝Qingyang Hualv
- 甘氨酸Ganan Suan
- 二钠Er Na
- 磷酸二氢钠Linsuan Erqing Na
- 苯氧乙醇Benyang Yichun
- 氯化钠Lvhua Na
- 吐温Tu Wen
- 注射用水Water for Injection (注射用水)
- 收获后经纯化Shouhuo Houjing Chunhua
- 二氢钠Erqing Na
药物知识说明
国药准字S20090006是一种在国家药监局注册认定的药品。该药品含有相关活性成分。
该药品关联的活性成分包括:二氢钠Erqing Na、二钠Er Na、吐温Tu Wen、氢氧化铝Qingyang Hualv、氯化钠Lvhua Na。这些成分信息来自国家药监局数据库。
您可以探索含有相同成分的其他药品:二氢钠-45136870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: 甲型肝炎灭活疫苗(Vero细胞)) is a medicine registered with the national drug regulatory authority. It contains active ingredient(s) as recorded.
Active ingredients associated with this product: 二氢钠Erqing Na, 二钠Er Na, 吐温Tu Wen, 氢氧化铝Qingyang Hualv, 氯化钠Lvhua Na.
Explore other medicines containing the same ingredient: 二氢钠 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: 甲型肝炎灭活疫苗(Vero细胞)Hepatitis A Inactivated Vaccine (Vero Cell)
- 规格Specification: 6~15岁人群用剂量:800EU/0.5mlRecorded Chinese specification: 6~15岁人群用剂量:800EU/0.5ml
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
- 上海泽润生物科技有限公司Chinese legal name: 上海泽润生物科技有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字S20090006
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)
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S20090006
Manufacturer
Chinese legal name: 上海泽润生物科技有限公司
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S20090006
生产企业
上海泽润生物科技有限公司
适应症
1.本品适用于6岁以上的甲型肝炎易感者。目前暂时尚未获得6岁以下儿童临床应用的数据。 2.接种本疫苗后,可刺激机体产生抗甲型肝炎病毒的免疫力,用于预防甲型肝炎。
用法用量
1.于上臂外侧三角肌附着处用酒精消毒后肌肉内注射; 2.成人用量(16岁及16岁以上人群):每次剂量1.0ml;儿童用量(6岁~16岁人群):每次剂量0.5ml。 3.初次免疫接种1剂疫苗,推荐6个月加强接种1剂疫苗。 本品尚未进行免疫持久性的临床观察。
不良反应
注射部位可有疼痛、瘙痒和红肿等;偶有全身不良反应如:发热、乏力、腹痛、腹泻、呕吐、食欲不振、皮疹、头痛等,一般可自行缓解。
禁忌
1.身体不适,腋温超过37.5℃者;
2.患急性传染病(包括肝炎等)或其它严重疾病者;
3.过敏体质者。包括对本疫苗中的任何一种成份有过敏史的人或注射第一剂疫苗后有过敏反应的人停用本疫苗。
注意事项
1.在包装和标签规定的有效期内使用;
2.疫苗不得冻结,若已冻结应做废弃处理;
3.疫苗若有异物、摇不散块状物或瓶身有裂纹、破裂者,均不得使用;
4.疫苗在保存中可能有微细白色沉淀物,使用时需摇匀;
5.勿使疫苗接触消毒剂;
6.注射免疫球蛋白者,应间隔1个月以上再接种本疫苗;
7.妊娠期妇女慎用。
贮藏
2~8℃保存。
规格
6~15岁人群用剂量:800EU/0.5ml
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.