Yixing Ganyan Renmian Yiqiu Danbai (乙型肝炎人免疫球蛋白)乙型肝炎人免疫球蛋白
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
- 广东卫伦生物制药有限公司Chinese legal name: 广东卫伦生物制药有限公司
主要成分Active Ingredients
- 人乙型肝炎免疫球蛋白Renyi Xinggan Yanmian Yiqiu Danbai
药物知识说明
人乙型肝炎免疫球蛋白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：人乙型肝炎免疫球蛋白Renyi Xinggan Yanmian Yiqiu Danbai。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：人乙型肝炎免疫球蛋白-113e72e7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: 乙型肝炎人免疫球蛋白) is a medicine registered with the national drug regulatory authority. It contains active ingredient(s) as recorded.
Active ingredients associated with this product: 人乙型肝炎免疫球蛋白Renyi Xinggan Yanmian Yiqiu Danbai.
Explore other medicines containing the same ingredient: 人乙型肝炎免疫球蛋白 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: 乙型肝炎人免疫球蛋白Recorded Chinese name: 乙型肝炎人免疫球蛋白
- 规格Specification: 200IU/瓶200 IU/bottle
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
- 广东卫伦生物制药有限公司Chinese legal name: 广东卫伦生物制药有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字S20043063
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S20043063
Manufacturer
Chinese legal name: 广东卫伦生物制药有限公司 (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S20043063
生产企业
广东卫伦生物制药有限公司(国产)
适应症
本品主要用于乙型肝炎预防。适用于:|1.乙型肝炎表面抗原(HbsAg)阳性母亲所生的婴儿。|2.意外感染的人群。|3.与乙型肝炎患者和乙型肝炎病毒携带者密切接触者。
用法用量
用法:本品只限肌内注射,不得用于静脉输注。用量:|1.母婴阻断:HBsAg阳性母亲所生婴儿出生24小时内注射本品100IU;注射乙型肝炎疫苗的剂量及时间见乙型肝炎疫苗说明书或按医生推荐的其他适宜方案。|2.乙型肝炎预防:一次注射量儿童为100IU,成人为200IU,必要时可间隔3～4周再注射一次。|3.意外感染者,立即(最迟不超过7天)按体重注射8IU～10IU/kg,隔月再注射1次。
不良反应
一般不会出现不良反应,少数人有红肿、疼痛感,无需特殊处理,可自行恢复。
禁忌
1.对人免疫球蛋白过敏或有其他严重过敏史者。|2.有IgA抗体的选择性IgA缺乏者。
注意事项
1.?本品应为无色或淡黄色可带乳光澄清液体。久存可能出现微量沉淀,但一经摇动应立即消散,如有摇不散的沉淀或异物不得使用。|2.玻瓶破裂、过期失效者不得使用。|3.本品开启后,应一次输注完毕,不得分次使用或给第二个人使用。
贮藏
2～8℃避光保存
规格
200IU/瓶
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.