Recorded Chinese product: 注射用放线菌素D注射用放线菌素D
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
- 海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司
主要成分Active Ingredients
- 放线菌素DFangxian Junsu
药物知识说明
放线菌素D是一种在国家药监局注册认定的药品。该药品含有放线菌素d-23610a00等成分。
该药品关联的活性成分包括：放线菌素d。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：海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司。
您可以探索含有相同成分的其他药品：放线菌素d-23610a00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: 注射用放线菌素D) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Manufacturers recorded for this product: 海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司.
Explore other medicines containing the same ingredient: 放线菌素d 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: 注射用放线菌素DRecorded Chinese product: 注射用放线菌素D
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 0.2mg*5支0.2 mg × 5 units
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
- 海正辉瑞制药有限公司Chinese legal name: 海正辉瑞制药有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20023504
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H20023504
Manufacturer
Chinese legal name: 海正辉瑞制药有限公司 (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
Protect from light and keep tightly closed.
Specification
0.2 mg × 5 units
中文说明书原文Original Chinese source label
批准文号
国药准字H20023504
生产企业
海正辉瑞制药有限公司(国产)
适应症
1.对霍奇金病(HD)及神经母细胞瘤疗效突出,尤其是控制发热. 2.对无转移的绒癌初治时单用本药,治愈率达90%～100%,与单用MTX的效果相似. 3.对睾丸癌亦有效,一般均与其它药物联合应用. 4.与放疗联合治疗儿童肾母细胞瘤(Wilms瘤)可提高生存率,对尤文肉瘤和横纹肌肉瘤亦有效.
用法用量
1.本品静注:一般成人每日300～400μg(6～8μg/Kg),溶于0.9%氯化钠注射液20～40ml中,每日一次,10日为一疗程,间歇期两周,一疗程总量4～6mg。 2.本品也可作腔内注射。在联合化疗中,剂量及时间尚不统一
不良反应
1.骨髓抑制为剂量限制性毒性,血小板及粒细胞减少,最低值见于给药后10～21天,尤以血小板下降为著。
2.胃肠道反应多见于每次剂量超过500μg时,表现为恶心、呕吐、腹泻,少数有口腔溃疡,始于用药数小时后,有时严重,为急性剂量限制性毒性。
3.脱发始于给药后7～10天,可逆。
4.少数出现胃炎、肠炎或皮肤红斑、脱屑、色素沉着、肝肾功能损害等,均可逆。
5.漏出血管对软组织损害显著。
禁忌
有患水痘病史者忌用。
注意事项
1.当本品漏出血管外时,应即用1%普鲁卡因局部封闭,或用50～100mg氢化可的松局部注射,及冷湿敷;
2.骨髓功能低下、有痛风病史、肝功能损害、感染、有尿酸盐性肾结石病史、近期接受过放疗或抗癌药物者慎用本品。
3.有出血倾向者慎用本品。
贮藏
遮光，密闭保存。
规格
0.2mg*5支
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.