Laifu Mite (来氟米特)来氟米特
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
- 大连美罗大药厂Chinese legal name: 大连美罗大药厂
主要成分Active Ingredients
- 来氟米特Laifu Mite
药物知识说明
来氟米特是一种在国家药监局注册认定的药品。该药品含有来氟米特-278322e7等成分。
该药品关联的活性成分包括：来氟米特Laifu Mite。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：大连美罗大药厂Chinese legal name: 大连美罗大药厂。
您可以探索含有相同成分的其他药品：来氟米特-278322e7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: 来氟米特) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 来氟米特Laifu Mite.
Manufacturers recorded for this product: 大连美罗大药厂Chinese legal name: 大连美罗大药厂.
Explore other medicines containing the same ingredient: 来氟米特 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: 来氟米特Recorded Chinese name: 来氟米特
- 规格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
- 大连美罗大药厂Chinese legal name: 大连美罗大药厂
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20080046
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)
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H20080046
Manufacturer
Chinese legal name: 大连美罗大药厂 (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H20080046
生产企业
大连美罗大药厂(国产)
适应症
适用于成人类风湿关节炎，有改善病情作用。
用法用量
遵医嘱用。
不良反应
1.主要有腹泻、瘙痒、可逆性肝脏酶（ALT和AST）升高、脱发、皮疹等。
2.在国外临床试验中，来氟米特治疗1339例类风湿关节炎病人中，发生率≥3%的不良事件包括：乏力、腹痛、背痛、高血压、厌食、腹泻、消化不良、胃肠炎、肝脏酶升高、恶心、口腔溃疡、呕吐、体重减轻、关节功能障碍、腱鞘炎、头晕、头痛、支气管炎、咳嗽、呼吸道感染、咽炎、脱发、瘙痒、皮疹、泌尿系统感染等，以上不良事件均在安慰剂对照或阳性对照柳氮磺胺吡啶治疗组及MTX治疗组中发现，来氟米特治疗组以腹泻、肝脏酶升高、脱发、皮疹较为明显，在应用过程汇总应加以注意。
禁忌
其代谢产物过敏者及严重肝脏损害者禁用。
注意事项
1.临床试验发现来氟米特可引起一过性的SGPT升高和白细胞下降，服药初始阶段应定期检查SGPT和白细胞。检查间隔视病人情况而定。
2.严重肝脏损害和明确的乙肝或丙肝血清学指标的患者慎用。用药前及用药后每月检查SGPT，检测时间间隔视病人具体情况而定。
3.免疫缺陷、未控制的感染、活动性胃肠道疾病、肾功能不全、骨髓发育不良的患者慎用。
4.准备生育的男性应该考虑中断治疗，同时服药消胆胺。
5.如果剂量过大或出现毒性时，可给予消胆胺或活性炭快速降低M1浓度。
贮藏
遮光，密封保存。
规格
－－－－
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.