Aosha Libo (奥沙利铂)奥沙利铂
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
- 山东罗欣药业集团股份有限公司Chinese legal name: 山东罗欣药业集团股份有限公司
主要成分Active Ingredients
- 奥沙利铂Aosha Libo
药物知识说明
奥沙利铂是一种在国家药监局注册认定的药品。标注生产企业为山东罗欣药业集团股份有限公司。
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：山东罗欣药业集团股份有限公司Chinese legal name: 山东罗欣药业集团股份有限公司、山东罗欣药业集团股份有限公司Chinese legal name: 山东罗欣药业集团股份有限公司、山东罗欣药业集团股份有限公司Chinese legal name: 山东罗欣药业集团股份有限公司。
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: 奥沙利铂) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 山东罗欣药业集团股份有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 山东罗欣药业集团股份有限公司Chinese legal name: 山东罗欣药业集团股份有限公司, 山东罗欣药业集团股份有限公司Chinese legal name: 山东罗欣药业集团股份有限公司, 山东罗欣药业集团股份有限公司Chinese legal name: 山东罗欣药业集团股份有限公司.
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: 奥沙利铂Recorded Chinese name: 奥沙利铂
- 规格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.
生产企业Manufacturer
- 山东罗欣药业集团股份有限公司Chinese legal name: 山东罗欣药业集团股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20123344
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H20123344
Manufacturer
Chinese legal name: 山东罗欣药业集团股份有限公司 (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H20123344
生产企业
山东罗欣药业集团股份有限公司(国产)
适应症
对乳腺癌、卵巢癌、黑色素瘤和睾丸癌等有抑制作用，和5-氟脲嘧啶(5-FU)及亚叶酸钙合用，用于治疗转移性结肠癌、直肠癌。
用法用量
静脉滴注，20～25mg/(m2・d)，与5-FU[600～700mg/(m2・d)]和亚叶酸钙(300mg/m2・d)合用治疗转移性结肠癌，每3周重复1次，在5-FU给药前2～6小时经静脉注射。
不良反应
1.常见不良反应为感觉异常或肢端麻木、恶心、呕吐、腹泻、黏膜炎、血液系统毒性；|2.血红蛋白、白细胞、中性粒细胞、血小板等均不同程度下降与减少；|3.耳毒性较轻，发热、轻微肝功能异常、暂时性视力减退等。
禁忌
肾功能严重受损者、中性白细胞计数小于2×109/L和(或)血小板计数小于100×109/L的骨髓抑制患者、外周感觉神经病患者、妊娠及哺乳期妇女禁用。
注意事项
1.每次给药前应进行神经学检查和全血细胞计数检查，发现异常时应减少用药量。|2.肾脏或肝功能障碍者、严重骨髓抑制者等慎用。
贮藏
密封，置阴凉处。
规格
－－－－
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.