Warfarin Sodium Tablets (华法林钠片)华法林钠片

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

主要成分Active Ingredients

药物知识说明

华法林是一种在国家药监局注册认定的药品。该药品含有华法林-e1542025等成分。

该药品关联的活性成分包括:华法林warfarin。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:上海信谊药厂有限公司Chinese legal name: 上海信谊药厂有限公司。

您可以探索含有相同成分的其他药品:华法林-e1542025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

warfarin is a medicine registered with the national drug regulatory authority. It contains warfarin as active ingredient(s).

Active ingredients associated with this product: warfarinwarfarin.

Manufacturers recorded for this product: 上海信谊药厂有限公司Chinese legal name: 上海信谊药厂有限公司.

Explore other medicines containing the same ingredient: warfarin products.

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: 华法林钠片Warfarin Sodium Tablets (华法林钠片)
  • 剂型Dosage form: 片剂Tablets
  • 规格Specification: 2.5mg;2.5mg(薄膜衣片);1mg((薄膜衣)Recorded Chinese description: 2.5mg;2.5mg(薄膜衣片);1mg((薄膜衣)

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

  • 上海信谊药厂有限公司Chinese legal name: 上海信谊药厂有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H20084641

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H20084641

Manufacturer

Chinese legal name: 上海信谊药厂有限公司 (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H20084641

生产企业

上海信谊药厂有限公司(国产)

适应症

本品适用于需长期持续抗凝的患者。|1. 能防止血栓的形成及发展,用于治疗血栓栓塞性疾病。|2. 治疗手术后或创伤后的静脉血栓形成,并可作心肌梗死的辅助用药。|3. 对曾有血栓栓塞病患者及有术后血栓并发症危险者,可予预防性用药。

用法用量

1.口服,成人常用量:避免冲击治疗口服第1~3天3~4mg(年老体弱及糖尿病患者半量即可),3天后可给维持量一日2.5~5mg(可参考凝血时间调整剂量使INR值达2~3)。|2.因本品起效缓慢,治疗初2天由于血浆抗凝蛋白细胞被抑制可以存在短暂高凝状态,如须立即产生抗凝作用,可在开始同时应用肝素,待本品充分发挥抗凝效果后再停用肝素。

不良反应

1.过量易致各种出血。|2.早期表现有瘀斑、紫癜、牙龈出血、鼻衄、伤口出血经久不愈,月经量过多等3.出血可发生在任何部位,特别是泌尿和消化道。肠壁血肿可致亚急性肠梗阻,也可见硬膜下颅内血肿和穿刺部位血肿。|4.偶见不良反应有恶心、呕吐、腹泻、瘙痒性皮疹,过敏反应及皮肤坏死。|5.大量口服甚至出现双侧乳房坏死,微血管病或溶血性贫血以及大范围皮肤坏疽。|6.一次量过大的尤其危险。

禁忌

肝肾功能损害、严重高血压、凝血功能障碍伴有出血倾向、活动性溃疡、外伤、先兆流产、近期手术者禁用。妊娠期禁用。老年人或月经期应慎用。

注意事项

1.严格掌握适应症,在无凝血酶原测定的条件时,切不可滥用本品。|2.个体差异较大,治疗期间应严密观察病情,并依据凝血酶原时间INR值调整用量。治疗期间还应严密观察口腔黏膜、鼻腔、皮下出血及大便隐血、血尿等,用药期间应避免不必要的手术操作,选期手术者应停药7天,急诊手术者需纠正PTINR值≤1.6,避免过度劳累和易致损伤的活动。|3.若发生轻度出血,或凝血酶原时间已显著延长至正常的2.5倍以上,应即减量或停药。严重出血可静注维生素Kl10~20mg,用以控制出血,必要时可输全血、血浆或凝血酶原复合物。|4.于本品系间接作用抗凝药,半衰期长,给药5~7日后疗效才可稳定,因此,维持量足够与否务必观察5~7天后方能定论。

贮藏

遮光,密封保存。

规格

2.5mg;2.5mg(薄膜衣片);1mg((薄膜衣)

证据Evidence

  • 批准文号: 国药准字H20084641
  • rights: 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。

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.