Recorded Chinese product: 甲磺酸帕珠沙星滴眼液甲磺酸帕珠沙星滴眼液

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

帕珠沙星是一种在国家药监局注册认定的药品。该药品含有帕珠沙星-f173acb9等成分。

该药品关联的活性成分包括:帕珠沙星Pazhu Shaxing。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:浙江莎普爱思药业股份有限公司Chinese legal name: 浙江莎普爱思药业股份有限公司。

您可以探索含有相同成分的其他药品:帕珠沙星-f173acb9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: 甲磺酸帕珠沙星滴眼液) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: 帕珠沙星Pazhu Shaxing.

Manufacturers recorded for this product: 浙江莎普爱思药业股份有限公司Chinese legal name: 浙江莎普爱思药业股份有限公司.

Explore other medicines containing the same ingredient: 帕珠沙星 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: 甲磺酸帕珠沙星滴眼液Recorded Chinese product: 甲磺酸帕珠沙星滴眼液
  • 剂型Dosage form: 滴眼剂Eye drops
  • 规格Specification: 0.3%(以帕珠沙星计)Recorded Chinese 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

  • 浙江莎普爱思药业股份有限公司Chinese legal name: 浙江莎普爱思药业股份有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H20110022

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H20110022

Manufacturer

Chinese legal name: 浙江莎普爱思药业股份有限公司 (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H20110022

生产企业

浙江莎普爱思药业股份有限公司(国产)

适应症

用于敏感菌引起的细菌性结膜炎的治疗。

用法用量

滴眼,每次1-2滴,一日4次,通常7天为一疗程,或遵医嘱。

不良反应

国内二、三期临床试验显示,在共计509例细菌性结膜炎患者采用0.3%的甲磺酸帕珠沙星滴眼液治疗后,共有七例发生不良反应(发生率,1.5%),主要表现为眼局部的刺痛感、烧灼感、眼痒等,程度为中度。试验中未发现有全身不良反应。

禁忌

1.对本品成分过敏者禁用。
2..对帕珠沙星一级喹唑酮类抗生素有过敏史者禁用。

注意事项

1.为了防止耐药菌的出现等,原则上应首先确认临床致病菌对本品的敏感性,且尽量将用药时间控制在治疗疾病所需的最少时间内。
2.有支气管哮喘、皮疹、荨麻疹等过敏性疾病家族史的患者慎用;肾功能不全这慎用;心脏活循环功能异常者慎用;有抽出或癫痫等中枢神经系统疾病的患者慎用。
3.本品仅限于滴眼使用。
4.本品连续使用超过14天的安全性尚,未确立故不宜长期连续使用。
5.如使用后出现眼局部刺痛感、灼烧感等症状,应及时咨询医生。
6.为防止污染药液,滴眼时应注意避免容器的前端直接接触手、眼镜等部位。
7.当本品性状发生改变时禁用。
8.请将本品放在儿童不能接触的地方。

贮藏

密封,置阴凉处。

规格

0.3%(以帕珠沙星计)

证据Evidence

  • 批准文号: 国药准字H20110022
  • 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.