Recorded Chinese product: 甲磺酸倍他司汀片甲磺酸倍他司汀片
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
- 卫材(中国)药业有限公司Chinese legal name: 卫材(中国)药业有限公司
主要成分Active Ingredients
- 倍他司汀Beita Siting
药物知识说明
倍他司汀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：倍他司汀Beita Siting。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：倍他司汀-0c503e2f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: 甲磺酸倍他司汀片) is a medicine registered with the national drug regulatory authority. It contains active ingredient(s) as recorded.
Active ingredients associated with this product: 倍他司汀Beita Siting.
Explore other medicines containing the same ingredient: 倍他司汀 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: 甲磺酸倍他司汀片Recorded Chinese product: 甲磺酸倍他司汀片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 6mg6 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
- 卫材(中国)药业有限公司Chinese legal name: 卫材(中国)药业有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20040130
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H20040130
Manufacturer
Chinese legal name: 卫材(中国)药业有限公司 (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H20040130
生产企业
卫材(中国)药业有限公司(国产)
适应症
下列疾病伴发的眩晕、头晕感。 梅尼埃病、梅尼埃综合征、眩晕症。
用法用量
通常成人一次1～2片(甲磺酸倍他司汀一次量6～12mg)，一日3次饭后口服，可视年龄、症状酌情增减。
不良反应
1.在总病例2,254例中，26例(1.15%)有副作用的报告(市场销售后临床调查结果)
2.胃肠道：偶有(0.1%-5%)恶心、呕吐。
3.过敏：偶有(0.1%-5%)皮疹。
禁忌
禁用于对甲磺酸倍他司汀或处方中任何辅料有过敏史的患者。
注意事项
对下列患者需慎重给药：
1.有消化道溃疡史者或活动期消化道溃疡的患者。［由于本品具有组胺样作用，可能会通过影响H2受体而导致胃酸分泌］
2.支气管哮喘的患者。［由于本品具有组胺样作用，可能会通过影响H1受体而导致呼吸道收缩］
3.肾上腺髓质瘤患者。［由于本品具有组胺样作用,可能会导致肾上腺素分泌过度而使血压上升］
贮藏
遮光、密闭保存。
规格
6mg
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.