Fufang Huanlin Xianan Pian (复方环磷酰胺片)复方环磷酰胺片
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
- 沈阳经典药业有限公司Chinese legal name: 沈阳经典药业有限公司
主要成分Active Ingredients
- 环磷酰胺 人参茎叶总皂苷Recorded Chinese composition: 环磷酰胺 人参茎叶总皂苷
- 环磷酰胺Huanlin Xianan
- 人参茎叶总皂苷Renshen Jingye Zongzao Gan
药物知识说明
环磷酰胺 人参茎叶总皂苷是一种在国家药监局注册认定的药品。该药品含有人参茎叶总皂苷、环磷酰胺、环磷酰胺 人参茎叶总皂苷-e528090c等成分。
该药品关联的活性成分包括：人参茎叶总皂苷Renshen Jingye Zongzao Gan、环磷酰胺Huanlin Xianan、环磷酰胺 人参茎叶总皂苷Recorded Chinese composition: 环磷酰胺 人参茎叶总皂苷。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：沈阳经典药业有限公司Chinese legal name: 沈阳经典药业有限公司。
您可以探索含有相同成分的其他药品：人参茎叶总皂苷-3964b342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: 复方环磷酰胺片) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 人参茎叶总皂苷Renshen Jingye Zongzao Gan, 环磷酰胺Huanlin Xianan, 环磷酰胺 人参茎叶总皂苷Recorded Chinese composition: Recorded Chinese name: 环磷酰胺 Recorded Chinese name: 人参茎叶总皂苷.
Manufacturers recorded for this product: 沈阳经典药业有限公司Chinese legal name: 沈阳经典药业有限公司.
Explore other medicines containing the same ingredient: 人参茎叶总皂苷 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: 复方环磷酰胺片Recorded Chinese name: 复方环磷酰胺片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 环磷酰胺50mg,人参茎叶总皂苷50mgRecorded Chinese specification: 环磷酰胺50mg,人参茎叶总皂苷50mg
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
- 沈阳经典药业有限公司Chinese legal name: 沈阳经典药业有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H21022607
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H21022607
Manufacturer
Chinese legal name: 沈阳经典药业有限公司 (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
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H21022607
生产企业
沈阳经典药业有限公司(国产)
适应症
抗肿瘤药。本品适用于恶性淋巴瘤、多发性骨髓瘤、淋巴细胞白血病、神母细胞瘤，骨外骨肉瘤，横纹肌肉瘤,小儿横纹肌肉瘤，卵巢癌，肺癌，乳癌以及各种恶性淋巴瘤。
用法用量
口服。成人常用量:一次1片，一日3～4次。
不良反应
1.骨髓抑制为最常见的毒性,白细胞往往在给药后10～14天最低,多在第21天恢复正常,血小板减少比其他烷化剂少见;常见的副反应还有恶心、呕吐。严重程度与剂量有关。|2.环磷酰胺的代谢产物可产生严重的出血性膀胱炎,大量补充液体可避免。本品也可致膀胱纤维化。|3.当大剂量环磷酰胺(按体重50mg/kg)与大量液体同时给予时,可产生水中毒,可同时给予呋塞米以防止。|4.环磷酰胺可引起生殖系统毒性,如停经或精子缺乏,妊娠初期给药可致畸胎。|5.长期给予环磷酰胺可产生继发性肿瘤。|6.复方环磷酰胺可减轻严重免疫抑制。|7.用于白血病或淋巴瘤治疗时,易发生高尿酸血症及尿酸性肾病。|8.少见的副作用有发热、过敏、皮肤及指甲色素沉着、粘膜溃疡、谷丙转氨酶升高、荨麻疹、口咽部感觉异常或视力模糊。
禁忌
孕妇及哺乳期妇女禁用。
注意事项
1.下列情况应慎用:骨髓抑制、有痛风病史、肝功能损害、感染、肾功能损害、肿瘤细胞浸润骨髓、有泌尿素结石史、以前曾接受过化疗或放射治疗。|2.用药期间须定期检查白细胞计数及分类、血小板计数,肾功能(尿素氮 肌酐消除率),肝功能(血清胆红素、谷丙转氨酶)及血清尿酸水平。|3.肾功能损害时,环磷酰胺的剂量应减少至治疗量的1/2～1/3。|4.白血病、淋巴瘤病人出现尿酸性肾病时,可采用以下的方法预防:大量补液、碱化尿液及(或)给予别嘌醇。|5.当肿瘤细胞浸润骨髓或以往的化疗或放射治疗引起严重骨髓抑制,环磷酰胺的剂量应减少至治疗量的1/2～1/3。|6.如有明显的白细胞减少(特别是粒细胞减少)或血小板减少,应停用复方环磷酰胺片。|7.对诊断的干扰:本品可使血清胆碱酯酶减少,血及尿中尿酸水平增加。
贮藏
遮光，密封，在30℃以下保存。
规格
环磷酰胺50mg,人参茎叶总皂苷50mg
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.