Recorded Chinese product: 注射用培美曲塞二钠注射用培美曲塞二钠
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
- 亚宝药业集团股份有限公司Chinese legal name: 亚宝药业集团股份有限公司
主要成分Active Ingredients
- 培美曲塞二钠Peimei Qusai Erna
药物知识说明
培美曲塞二钠是一种在国家药监局注册认定的药品。该药品含有培美曲塞二钠-9bc77fb9等成分。
该药品关联的活性成分包括：培美曲塞二钠Peimei Qusai Erna。这些成分信息来自国家药监局数据库。
该药品标注的生产企业为：亚宝药业集团股份有限公司Chinese legal name: 亚宝药业集团股份有限公司。
您可以探索含有相同成分的其他药品：培美曲塞二钠-9bc77fb9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: 注射用培美曲塞二钠) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 培美曲塞二钠Peimei Qusai Erna.
Manufacturers recorded for this product: 亚宝药业集团股份有限公司Chinese legal name: 亚宝药业集团股份有限公司.
Explore other medicines containing the same ingredient: 培美曲塞二钠 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: 注射用培美曲塞二钠Recorded Chinese product: 注射用培美曲塞二钠
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 500mg(培美曲塞)Recorded Chinese specification: 500mg(培美曲塞)
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
- 亚宝药业集团股份有限公司Chinese legal name: 亚宝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H20080169
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H20080169
Manufacturer
Chinese legal name: 亚宝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H20080169
生产企业
亚宝药业集团股份有限公司(国产)
适应症
本品适用于与顺铂联合治疗无法手术的恶性胸膜间皮瘤.
用法用量
培美曲塞联合顺铂的推荐剂量为每21天500mg/m2,滴注10分钟,顺铂的推荐剂量为75mg/m2滴注超过2小时,应在培美曲塞给药结束30分钟后再给予顺铂滴注.接受顺铂治疗要有水化方案
不良反应
培美曲塞可以引起骨髓抑制包括中性粒细胞血小板减少和贫血骨髓抑制是常见的剂量限制性毒性
禁忌
禁用于对培美曲塞或药品其他成份有严重过敏史的患者.
注意事项
1.接受培美曲塞治疗同时应接受叶酸和维生素B的补充治疗可以预防或减少治疗相关的血液学或胃肠道不良反应
2.所有准备接受培美曲塞治疗的患者用药前需完成包括血小板计数在内的血细胞检查和血生化检查给药后需监测血细胞最低点及恢复情况临床研究时每周期的开始第天和第天需检查上述项目患者需在中性粒细胞≥/mm血小板≥, cells/mm肌酐清除率≥ml/min时才能开始培美曲塞治疗
3.培美曲塞只建议用0.9％的氯化钠注射液（不含防腐剂）溶解稀释培美曲塞溶液配好后应用.
4.0.9％氯化钠注射液稀释至100ml静脉滴注超过10分钟
5.配好的培美曲塞溶液置于冰箱冷藏或置于室温无需避光其物理及化学特性小时内保持稳定
6.禁用于对培美曲塞或药品其他成分有严重过敏史的患者.
贮藏
遮光，密封，干燥阴凉处（不超过20℃）保存。
规格
0.5g（以C20H21N5O6计）
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.