Ze Kang (泽康)泽康

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

主要成分Active Ingredients

药物知识说明

米托蒽醌是一种在国家药监局注册认定的药品。该药品含有相关活性成分。

该药品关联的活性成分包括:米托蒽醌Mituo Enkun。这些成分信息来自国家药监局数据库。

您可以探索含有相同成分的其他药品:米托蒽醌-4a1ba3ae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: 泽康) is a medicine registered with the national drug regulatory authority. It contains active ingredient(s) as recorded.

Active ingredients associated with this product: 米托蒽醌Mituo Enkun.

Explore other medicines containing the same ingredient: 米托蒽醌 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: 泽康Recorded Chinese name: 泽康
  • 剂型Dosage form: 注射剂Injection
  • 规格Specification: 100ml:5mg(以米托蒽醌计)Recorded Chinese specification: 100ml:5mg(以米托蒽醌计)

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

  • 清华紫光古汉生物制药股份有限公司Chinese legal name: 清华紫光古汉生物制药股份有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H20030013

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H20030013

Manufacturer

Chinese legal name: 清华紫光古汉生物制药股份有限公司

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H20030013

生产企业

清华紫光古汉生物制药股份有限公司

适应症

用于恶性淋巴瘤、乳腺癌和各种急性白血病。

用法用量

静脉滴注,每次滴注时间不少于30分钟。成人:单用本品一次12-14mg/m2体表面积,每3-4周一次;或4-8mg/m2,一日一次,连用3-5天,间隔2-3周。联合用药,一次5-10mg/m2体表面积,当总剂量超过140-160mg/m2时应警惕心脏毒性。

不良反应

1、中度骨髓抑制,主要是白细胞和血小板减少,为剂量限制性毒性。|2、可有恶心、呕吐、食欲减退、腹泻;偶见乏力、脱发、皮疹、口腔炎、尿道感染等。|3、心脏毒性,可有心悸、早博及心电图异常等,其发生与总剂量有关,总剂量超过140-160mg/m2时,心肌损害加重。在用过阿霉素,纵隔部位接受过放射治疗或原有心脏疾病的患者,总剂量不宜超过100-120mg/m2。文献报道本品发生心力衰竭的最低剂量为55-255mg/m2,发生在左心室排血量减少的最低剂量为21-150mg/m2。在使用阿霉素总剂量超过350mg/m2的患者,应在严密观察下使用本品,总剂量超过450mg/m2的患者不宜再用本品。|4、静脉滴注药液外溢时,会发生严重的局部反应。

禁忌

-

注意事项

-

贮藏

遮光,密闭,在阴凉处保存。

规格

100ml:5mg(以米托蒽醌计)

证据Evidence

  • 批准文号: 国药准字H20030013
  • rights: 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。

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.