Beiqing Xing (倍清星)倍清星
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
- 广东世信药业有限公司Chinese legal name: 广东世信药业有限公司
主要成分Active Ingredients
- 奥拉西坦 辅料为磷酸二氢钠Recorded Chinese composition: 奥拉西坦 辅料为磷酸二氢钠
- 乙二胺四乙酸二Yier Ansi Yisuan Er
- 奥拉西坦Aola Xitan
- 辅料为磷酸二氢钠和乙二胺四乙酸二Recorded Chinese composition: 辅料为磷酸二氢钠和乙二胺四乙酸二
药物知识说明
奥拉西坦 辅料为磷酸二氢钠是一种在国家药监局注册认定的药品。标注生产企业为广东世信药业有限公司。
该药品暂无关联的活性成分信息。
该药品标注的生产企业为：广东世信药业有限公司Chinese legal name: 广东世信药业有限公司、广东世信药业有限公司Chinese legal name: 广东世信药业有限公司、广东世信药业有限公司Chinese legal name: 广东世信药业有限公司。
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: 倍清星) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 广东世信药业有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 广东世信药业有限公司Chinese legal name: 广东世信药业有限公司, 广东世信药业有限公司Chinese legal name: 广东世信药业有限公司, 广东世信药业有限公司Chinese legal name: 广东世信药业有限公司.
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: 倍清星Recorded Chinese name: 倍清星
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 5ml:1.0g。5 mL:1.0 g
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.
生产企业Manufacturer
- 广东世信药业有限公司Chinese legal name: 广东世信药业有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20050860
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H20050860
Manufacturer
Chinese legal name: 广东世信药业有限公司 (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H20050860
生产企业
广东世信药业有限公司(国产)
适应症
适用轻中度血管性痴呆、老年性痴呆以及脑外伤等症引起的记忆与智能障碍。
用法用量
1.静脉滴注，每次4～6g，每日一次。|2.用前加入到100-250ml5%葡萄糖注射液或0.9%氯化钠注射液中，摇匀后静脉滴注。|3.对功能缺失的治疗通常疗程为2周，对记忆与智能障碍的治疗通常疗程为3周，可酌情增减用量。
不良反应
1.据报道奥拉西坦的不良反应较少，可有焦虑不安、皮肤搔痒、皮疹、恶心、胃痛等，停药后可自行消退。|2.少数患者出现精神兴奋和睡眠异常时应减量。|3.於东晖等进行奥拉西坦胶囊人体耐受性试验时，发现一次口服最大剂量2000mg奥拉西坦后未出现任何不良反应，受试者均能良好接受。|4.在Villardita等应用奥拉西坦对患有轻、中度痴呆的60例患者为期1年的治疗中，他们未发现严重的副反应，并认为每天服用奥拉西坦1600mg是安全的。
禁忌
对本品过敏者、严重肾功能损害者禁用。
注意事项
1.轻、中度肾功能不全者应慎用，必需使用本品时，须减量。|2.患者出现精神兴奋和睡眠紊乱时，应减量。
贮藏
遮光，密封，在阴凉（不超过20℃）处保存。
规格
5ml:1.0g。
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.