Qiangji Niao Pian (羟基脲片)羟基脲片
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
- 湖南洞庭药业股份有限公司Chinese legal name: 湖南洞庭药业股份有限公司
主要成分Active Ingredients
- 羟基脲Qiangji Niao
药物知识说明
羟基脲是一种在国家药监局注册认定的药品。该药品含有羟基脲-de754b91等成分。
该药品关联的活性成分包括：羟基脲Qiangji Niao。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：湖南洞庭药业股份有限公司Chinese legal name: 湖南洞庭药业股份有限公司。
您可以探索含有相同成分的其他药品：羟基脲-de754b91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: 羟基脲片) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 羟基脲Qiangji Niao.
Manufacturers recorded for this product: 湖南洞庭药业股份有限公司Chinese legal name: 湖南洞庭药业股份有限公司.
Explore other medicines containing the same ingredient: 羟基脲 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: 羟基脲片Recorded Chinese name: 羟基脲片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 0.5g0.5 g
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
- 湖南洞庭药业股份有限公司Chinese legal name: 湖南洞庭药业股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H43022021
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H43022021
Manufacturer
Chinese legal name: 湖南洞庭药业股份有限公司
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
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H43022021
生产企业
湖南洞庭药业股份有限公司
适应症
1.慢性粒细胞白血病(CML)有效,并可用于对马利兰耐药的CML。|2.对黑色素瘤、黑棘皮瘤、肾癌、头颈部癌有一定疗效,与放疗联合对头颈部及宫颈鳞癌有效。
用法用量
1.口服,CML每日20～60mg/kg,每周两次,6周为一疗程;|2.头颈癌、宫颈鳞癌等每次80mg/kg,每三天1次,需与放疗合用。
不良反应
1.骨髓抑制为剂量限制性毒性,可致白细胞和血小板减少,停药后1～2周可恢复。|2.有时出现胃肠道反应,尚有致睾丸萎缩和致畸胎的报道。|3.偶有中枢神经系统症状和脱发,亦有本药引起药物性发热的报道,重复给药时可再出现。|4.国外有报道，在骨髓增殖异常的病人中，使用羟基脲出现了皮肤血管毒性反应，包括血管溃疡和血管坏死，报道出现血管毒性的病人多数曾经或者正在接受干扰素治疗。如果使用羟基脲发生血管溃疡或者坏死，应当停止用药。
禁忌
水痘、带状疱疹及各种严重感染禁用。
注意事项
1.服用本品可使患者免疫机能受到抑制,故用药期间避免接种死或活病毒疫苗,一般停药2个月至1年才可考虑接种疫苗。|2.服用本品时应适当增加液体的摄入量,以增加尿量及尿酸的排泄。|3.定期监测白细胞、血小板、血中尿素氮、尿酸及肌苷浓度。|4.下列情况应慎用：|(1)严重贫血未纠正前、骨髓抑制、肾功能不全、痛风、尿酸盐结石史等。|(2)对羟基脲的处理过程应该谨慎。配药或者接触装有羟基脲的药瓶时应当戴上一次性手套，且在接触含有羟基脲的药瓶或者胶囊（片）前后都要洗手。该药应当远离儿童。
贮藏
遮光，密封保存。
规格
0.5g
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.