Recorded Chinese product: 卡莫司汀注射液卡莫司汀注射液
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
- 通化茂祥制药有限公司Chinese legal name: 通化茂祥制药有限公司
主要成分Active Ingredients
- 卡莫司汀Kamo Siting
药物知识说明
卡莫司汀是一种在国家药监局注册认定的药品。标注生产企业为通化茂祥制药有限公司。
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：通化茂祥制药有限公司Chinese legal name: 通化茂祥制药有限公司、通化茂祥制药有限公司Chinese legal name: 通化茂祥制药有限公司、通化茂祥制药有限公司Chinese legal name: 通化茂祥制药有限公司。
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: 卡莫司汀注射液) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 通化茂祥制药有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 通化茂祥制药有限公司Chinese legal name: 通化茂祥制药有限公司, 通化茂祥制药有限公司Chinese legal name: 通化茂祥制药有限公司, 通化茂祥制药有限公司Chinese legal name: 通化茂祥制药有限公司.
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: 卡莫司汀注射液Recorded Chinese product: 卡莫司汀注射液
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 2ml:0.125g2 mL:0.125 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
- 通化茂祥制药有限公司Chinese legal name: 通化茂祥制药有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H22023473
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H22023473
Manufacturer
Chinese legal name: 通化茂祥制药有限公司 (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H22023473
生产企业
通化茂祥制药有限公司(国产)
适应症
因能够通过血脑屏障，故对脑瘤（恶性胶质细胞瘤、脑干胶质瘤、成神经管细胞瘤、星形胶质细胞瘤、室管膜瘤）、脑转移瘤和脑膜白血病有效，对恶性淋巴瘤、多发性骨髓瘤，与其它药物合用对恶性黑色素瘤有效。
用法用量
静脉注射按体表面积100mg/m2，每日一次，连用2～3日；或200mg/m2，用一次，每6～8周重复。溶入5%葡萄糖或生理盐水150ml中快速点滴。
不良反应
一次静脉注射后，骨髓抑制经常发生在用药后4～6周，白细胞最低值见于5～6周，在6～7周逐渐恢复。但多次用药，可延迟至10～12周恢复。一次静脉注射后，血小板最低值见于4～5周，在6～7周内恢复，血小板下降常比白细胞严重。静脉注射部位可产生血栓性静脉炎。大剂量可产生脑脊髓病。长期治疗可产生肺间质或肺纤维化。有时甚至l～2疗程后即出现肺并发症，部分患者不能恢复。此外可产生恶心、呕吐等消化道反应，用药后2小时即可出现，常持续4～6小时。对肝肾均有影响，肝脏损害常可恢复，肾脏毒性可见氮质血症，功能减退，肾脏缩小。本品有继发白血病的报道。亦有致畸胎的可能性。本品可抑制睾丸或卵子功能，引起闭经或精子缺乏。
禁忌
既往对本药过敏的病人，妊娠及哺乳期妇女禁用。
注意事项
1、老年人易有肾功能减退，可影响排泄，应慎用。2、对诊断的干扰：本品可引起肝肾功能异常。3、下列情况慎用：骨髓抑制、感染、肝肾功能异常、接受过放射治疗或抗癌药治疗的患者。4、用药期间应注意检查血常规、血小板、肝肾功能、肺功能。5、本品可抑制身体免疫机制，使疫苗接种不能激发身体抗体产生。化疗结束后三个月内不宜接种活疫苗。6、预防感染，注意口腔卫生。
贮藏
遮光，密闭，在5℃以下冷冻处保存。
规格
2ml:0.125g
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.