Recorded Chinese product: 注射用盐酸吡柔比星注射用盐酸吡柔比星
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
- 海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司
主要成分Active Ingredients
- 吡柔比星Birou Bixing
药物知识说明
吡柔比星是一种在国家药监局注册认定的药品。标注生产企业为海正辉瑞制药有限公司。
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：海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司、海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司、海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司。
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: 注射用盐酸吡柔比星) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 海正辉瑞制药有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司, 海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司, 海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司.
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: 注射用盐酸吡柔比星Recorded Chinese product: 注射用盐酸吡柔比星
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 10mg10 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.
生产企业Manufacturer
- 海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20045983
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H20045983
Manufacturer
Chinese legal name: 海正辉瑞制药有限公司 (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H20045983
生产企业
海正辉瑞制药有限公司(国产)
适应症
本品用于治疗乳腺癌、恶性淋巴瘤、急性白血病、头颈部恶性肿瘤、胃癌、泌尿生殖系统肿瘤（膀胱癌、输尿管癌、肾盂癌、卵巢癌、宫颈癌、子宫内膜癌）。
用法用量
将本品加入5%葡萄糖注射液或注射用水10ml溶解。可静脉、动脉、膀胱内注射。 1.静注:一般按体表面积一次25～40mg/m2; 2.动脉给药:如头颈部癌按体表面积一次7～20mg/m2,一日1次,共用5～7日,亦可每次14～25mg/m2,每周一次; 3.膀胱内给药:按体表面积一次15～30mg/m2,稀释为500～1000μg/ml浓度,注入膀胱腔内保留1～2h,每周。次为一疗程,可用2～5疗程。
不良反应
1.骨髓抑制为剂量限制性毒性,主要为粒细胞减少,平均最低值在14天,第21天恢复,贫血及血小板减少少见。
2.心脏毒性低于ADM,急性心脏毒性主要为可逆性心电图变化,如心律失常或非特异性ST-T异常,慢性心脏毒性呈剂量累积性。
3.胃肠道反应:恶心、呕吐、食欲不振、口腔粘膜炎,有时出现腹泻。
4.其它:肝肾功能异常、脱发、皮肤色素沉着等,偶有皮疹。膀胱内注入可出现尿频、排尿痛、血尿等膀胱刺激症状,甚至膀胱萎缩。
禁忌
严重器质性心脏病或心功能异常者及对本品过敏者禁用;妊娠期、哺乳及育龄期妇女禁用
注意事项
1.严格避免注射时渗漏至血管外,密切监测心脏、血象、肝肾功能及继发感染等情况。原则上每周期均要进行心电图检查,对合并感染、水痘等症状的患者应慎用本药,高龄者适当减量。
2.溶解本品只能用5%葡萄糖注射液或注射用水,以免pH的原因影响效价或浑浊。溶解后药液,即时用完,室温下放置不得超过6小时。
贮藏
光，密闭，在阴凉处（不超过20℃）保存。
规格
10mg
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.