Recorded Chinese product: 注射用异环磷酰胺注射用异环磷酰胺
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
- 齐鲁制药(海南)有限公司Chinese legal name: 齐鲁制药(海南有限公司)
主要成分Active Ingredients
- 异环磷酰胺 其辅料为甘露醇Recorded Chinese composition: 异环磷酰胺 其辅料为甘露醇
- 甘氨酸Ganan Suan
- 异环磷酰胺Yihuan Linxian An
- 其辅料为甘露醇和甘氨酸Recorded Chinese composition: 其辅料为甘露醇和甘氨酸
药物知识说明
异环磷酰胺 其辅料为甘露醇是一种在国家药监局注册认定的药品。该药品含有其辅料为甘露醇和甘氨酸、异环磷酰胺、异环磷酰胺 其辅料为甘露醇-5f2aeb60等成分。
该药品关联的活性成分包括：其辅料为甘露醇和甘氨酸、异环磷酰胺Yihuan Linxian An、异环磷酰胺 其辅料为甘露醇、甘氨酸Ganan Suan。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：齐鲁制药(海南)有限公司Chinese legal name: 齐鲁制药(海南有限公司)。
您可以探索含有相同成分的其他药品：其辅料为甘露醇和甘氨酸-c426ba7a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: 注射用异环磷酰胺) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 异环磷酰胺Yihuan Linxian An, 甘氨酸Ganan Suan.
Manufacturers recorded for this product: 齐鲁制药(海南)有限公司Chinese legal name: 齐鲁制药(海南有限公司).
Explore other medicines containing the same ingredient: 其辅料为甘露醇和甘氨酸 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: 注射用异环磷酰胺Recorded Chinese product: 注射用异环磷酰胺
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 0.5g或1.0gRecorded Chinese specification
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
- 齐鲁制药(海南)有限公司Chinese legal name: 齐鲁制药(海南有限公司)
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20093079
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H20093079
Manufacturer
Chinese legal name: 齐鲁制药(海南)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H20093079
生产企业
齐鲁制药(海南)有限公司(国产)
适应症
本品适用于睾丸癌、卵巢癌、乳腺癌、肉瘤、恶性淋巴瘤和肺癌等。
用法用量
1. 单药治疗 静脉注射按体表面积每次1.2~2.5g/m2,连续5日为一疗程。|2. 联合用药 静脉注射按体表面积每次1.2~2.0g/m2,连续5日为一疗程。|3.每一疗程间隙3~4周.500～600mg/m2。
不良反应
1.骨髓抑制:白细胞减少较血小板减少为常见，最低值在用药后1～2周，多在2～2周后恢复。对肝功有影响。胃肠道反应:包括食欲减退、恶心及呕吐，一般停药1～。天即可消失。|2.泌尿道反应:可致出血性膀胱炎，表现为排尿困难、尿频和尿痛、可在给药后几小时或几周内出现，通常在停药后几天内消失。|3.中枢神经系统毒性:与剂量有关，通常表现为焦虑不安、神情慌乱、幻觉和乏力等。少见晕厥、癫痫样发作甚至昏迷。|4.少见的有一过性无症状肝肾功能异常;若高剂量用药可因肾毒性产生代谢性酸中毒。罕见心脏和肺毒性。|5.其他反应尚包括脱发、恶心和呕吐等。注射部位可产生静脉炎。|6.长期用药可产生免疫抑制、垂体功能低下、不育症和继发性肿瘤。
禁忌
严重骨髓抑制患者? 对本品过敏者、妊娠及哺乳期妇女禁用。
注意事项
1.本品的代谢产物对尿路有刺激性,应用时应鼓励患者多饮水,大剂量应用时应水化、利尿,同时给予尿路保护剂美司钠。|2.低白蛋白血症、肝肾功能不全、骨髓抑制及育龄期妇女慎用。|3.本品水溶液不稳定,须现配现用。|4.用药期间应定期检查白细胞,血小板和肝肾功能测定。
贮藏
遮光，密闭，在冷处 (2～10℃) 保存。
规格
0.5g或1.0g
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.