Recorded Chinese product: 注射用甲磺酸酚妥拉明注射用甲磺酸酚妥拉明
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
- 上海复旦复华药业有限公司Chinese legal name: 上海复旦复华药业有限公司
主要成分Active Ingredients
- 酚妥拉明Fentuo Laming
药物知识说明
酚妥拉明是一种在国家药监局注册认定的药品。该药品含有酚妥拉明-1f4bf4ba等成分。
该药品关联的活性成分包括：酚妥拉明Fentuo Laming。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：上海复旦复华药业有限公司Chinese legal name: 上海复旦复华药业有限公司。
您可以探索含有相同成分的其他药品：酚妥拉明-1f4bf4ba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: 注射用甲磺酸酚妥拉明) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 酚妥拉明Fentuo Laming.
Manufacturers recorded for this product: 上海复旦复华药业有限公司Chinese legal name: 上海复旦复华药业有限公司.
Explore other medicines containing the same ingredient: 酚妥拉明 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: 注射用甲磺酸酚妥拉明Recorded Chinese product: 注射用甲磺酸酚妥拉明
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 10mg10 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.
主要成分Ingredients
生产企业Manufacturer
- 上海复旦复华药业有限公司Chinese legal name: 上海复旦复华药业有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H10890046
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H10890046
Manufacturer
Chinese legal name: 上海复旦复华药业有限公司 (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H10890046
生产企业
上海复旦复华药业有限公司(国产)
适应症
嗜铬细胞瘤的治疗和术前准备。||嗜铬细胞瘤的诊断(酚妥拉明试验)。||预防和治疗因静脉注射去甲肾上腺素外溢而引起的皮肤坏死。心力衰竭时减轻心脏负荷。
用法用量
成人常用量：(1)酚妥拉明试验：静脉注射5mg，也可先注入2.5mg，若反应阴性，再给5mg，如此则假阳性的结果可以减少，也减少血压巨降的危险性。(2)防止皮肤坏死：在每1000ml含去甲肾上腺素溶液中加入本品10mg静脉滴注，作为预防之用。已发生去甲肾上腺素外溢，用本品5-10mg加10ml氯化钠注射液作局部浸润，此法在外溢后12小时内有效。(3)嗜铬细胞瘤手术：术前1-2小时静脉注射5mg，术时静脉注射5mg或滴注每分钟0.5-1mg，以防肿瘤手术时肾上腺素大量释出。(4)心力衰竭时减轻心脏负荷：静脉滴注每分钟0.17-0.4mg。儿童常用量：(1)酚妥拉明试验：静脉注射一次1mg，亦可按体重0.1mg/kg或按体表面积3mg/m2，或肌内注射3mg。(2)嗜铬细胞瘤手术：术前1-2小时肌内或静脉注射1mg，亦可按体重0.1mg/kg或按体表面积3mg/m2，必要时可重复；术时静脉注射1mg，亦可按体重0.1mg/kg或按体表面积3mg/m2。
不良反应
较常见的有体位性低血压、心动过速、心律失常，鼻塞、恶心、呕吐等，晕倒和乏力较少见；突然胸痛(心肌梗死)、神志模糊、头痛、共济失调、言语含糊等极少见，这些都可能是心、脑血管痉挛或阻塞的表现。
禁忌
1．严重动脉硬化。|||2．严重肾功能不全。|||3．胃炎或胃溃疡。|||4．对本品过敏者。
注意事项
1．有报道指出，使用本品可出现心肌梗死、脑血管痉挛和脑血管疾病，特别是在低血压时。
贮藏
遮光，密闭保存。
规格
10mg
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.