Recorded Chinese product: 盐酸氮芥注射液盐酸氮芥注射液
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
- 上海旭东海普药业有限公司Chinese legal name: 上海旭东海普药业有限公司
主要成分Active Ingredients
- 氮芥Dan Jie
药物知识说明
氮芥是一种在国家药监局注册认定的药品。标注生产企业为上海旭东海普药业有限公司。
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：上海旭东海普药业有限公司Chinese legal name: 上海旭东海普药业有限公司、上海旭东海普药业有限公司Chinese legal name: 上海旭东海普药业有限公司、上海旭东海普药业有限公司Chinese legal name: 上海旭东海普药业有限公司。
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: 盐酸氮芥注射液) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 上海旭东海普药业有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 上海旭东海普药业有限公司Chinese legal name: 上海旭东海普药业有限公司, 上海旭东海普药业有限公司Chinese legal name: 上海旭东海普药业有限公司, 上海旭东海普药业有限公司Chinese legal name: 上海旭东海普药业有限公司.
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: 盐酸氮芥注射液Recorded Chinese product: 盐酸氮芥注射液
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 1ml：5mg1 mL:5 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
- 上海旭东海普药业有限公司Chinese legal name: 上海旭东海普药业有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H31020897
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H31020897
Manufacturer
Chinese legal name: 上海旭东海普药业有限公司 (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
Protect from light and keep tightly closed.
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H31020897
生产企业
上海旭东海普药业有限公司(国产)
适应症
恶性淋巴瘤，尤其是霍奇金病的治疗，腔内用药对控制癌性胸腔、心包腔及腹腔积液有较好疗效。
用法用量
静脉注射：每次4-6mg/m2(或0.1mg/kg)，加生理盐水10ml由输液小壶或皮管中冲入，并用生理盐水或5%葡萄糖液冲洗血管，每周1次，连用2次，休息1-2周重复。腔内给药：每次5-10mg(1-2支)，加生理盐水20-40ml稀释，在抽液后即时注入，每周1次，可根据需要重复。局部皮肤涂抹：新配制每次5mg(1支)，加生理盐水50ml，每日1-2次，主要用于皮肤蕈样霉菌病。
不良反应
骨髓抑制：主要表现为白细胞和血小板减少，严重时可导致全血细胞减少。白细胞下降最低值在注射本品后第7-10天，停药1-2周后多可恢复。
禁忌
对本品过敏者禁用。
注意事项
本品剂量限制性毒性为骨髓抑制，故应密切观察血象变化，每周查血象1-2次。氮芥对局部组织刺激性强，若漏出血管外，可导致局部组织坏死，故严禁口服、皮下及肌肉注射，药物一旦溢出，应立即用硫代硫酸钠注射液或1%普鲁卡因注射液局部注射，用冰袋冷敷局部6-12小时。氮芥水溶液极易分解，故药物开封后应在10分钟内注人体内。凡有骨髓抑制、感染、肿瘤细胞侵及骨髓、曾接受过多程化疗或放疗者应慎用。
贮藏
遮光，密闭保存。
规格
1ml：5mg
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.