Recorded Chinese product: 蕲蛇酶注射液蕲蛇酶注射液

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

从蕲蛇毒中提取的凝血酶样酶是一种在国家药监局注册认定的药品。标注生产企业为福建汇天生物药业有限公司。

该药品暂无关联的活性成分信息。

该药品标注的生产企业为:福建汇天生物药业有限公司Chinese legal name: 福建汇天生物药业有限公司、福建汇天生物药业有限公司Chinese legal name: 福建汇天生物药业有限公司、福建汇天生物药业有限公司Chinese legal name: 福建汇天生物药业有限公司。

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: 蕲蛇酶注射液) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 福建汇天生物药业有限公司.

No active ingredient relationships are currently recorded for this product in MedicineGraph.

Manufacturers recorded for this product: 福建汇天生物药业有限公司Chinese legal name: 福建汇天生物药业有限公司, 福建汇天生物药业有限公司Chinese legal name: 福建汇天生物药业有限公司, 福建汇天生物药业有限公司Chinese legal name: 福建汇天生物药业有限公司.

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: 蕲蛇酶注射液Recorded Chinese product: 蕲蛇酶注射液
  • 剂型Dosage form: 注射剂Injection
  • 规格Specification: 1ml:0.75单位Recorded Chinese description: 1ml:0.75单位

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

  • 福建汇天生物药业有限公司Chinese legal name: 福建汇天生物药业有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H19990362

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H19990362

Manufacturer

Chinese legal name: 福建汇天生物药业有限公司 (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

English translation unavailable. The original Chinese source label remains available below.

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H19990362

生产企业

福建汇天生物药业有限公司(国产)

适应症

本品可用于急性脑梗塞的治疗。

用法用量

本品每次0.75单位,溶于250ml或500ml灭菌生理盐水中静脉滴注3小时以上,每日一次,连用7-14天为一个疗程;根据病情需要可重复一个疗程。本品应在医生指导下使用。

不良反应

本品在常规治疗剂量下可致血小板聚集功能明显抑制,部分患者出现血小板计数减少,皮下及粘膜少量出血,停药后可自行恢复。本品可引起过敏反应如皮疹。

禁忌

对本品成份过敏者、有出血倾向者或严重凝血障碍者、溃疡病、肺结核病活动期均禁用。

注意事项

1、肝、肾功能不良者应慎用。 2、用药前需做过敏试验:取本品0.1ml,加灭菌生理盐水至1ml,皮内注射0.1ml,30分钟后观察,丘疹直径超过15mm者判为阳性。 3、本品对血小板有一时性抑制作用,用药期间应定期检查血小板计数,血小板降至正常以下,应暂停使用,待恢复正常可重复使用。再使用本品前仍须做过敏试验。 4、过敏体质者及对其他蛇酶制剂过敏试验阳性者不宜使用。若有过敏反应发生应及时给予相应处理。

贮藏

密闭,在4~10℃保存。

规格

1ml:0.75单位

证据Evidence

  • 批准文号: 国药准字H19990362
  • 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.