Recorded Chinese product: 酮咯酸氨丁三醇滴眼液酮咯酸氨丁三醇滴眼液
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
- 成都倍特药业有限公司Chinese legal name: 成都倍特药业有限公司
主要成分Active Ingredients
- 酮咯酸氨丁三醇Tongge Suanan Dingsan Chun
药物知识说明
酮咯酸氨丁三醇是一种在国家药监局注册认定的药品。该药品含有酮咯酸氨丁三醇-0d798185等成分。
该药品关联的活性成分包括：酮咯酸氨丁三醇Tongge Suanan Dingsan Chun。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：成都倍特药业有限公司Chinese legal name: 成都倍特药业有限公司。
您可以探索含有相同成分的其他药品：酮咯酸氨丁三醇-0d798185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: 酮咯酸氨丁三醇滴眼液) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 酮咯酸氨丁三醇Tongge Suanan Dingsan Chun.
Manufacturers recorded for this product: 成都倍特药业有限公司Chinese legal name: 成都倍特药业有限公司.
Explore other medicines containing the same ingredient: 酮咯酸氨丁三醇 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: 酮咯酸氨丁三醇滴眼液Recorded Chinese product: 酮咯酸氨丁三醇滴眼液
- 剂型Dosage form: 滴眼剂Eye drops
- 规格Specification: 5ml:25mg5 mL:25 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
- 成都倍特药业有限公司Chinese legal name: 成都倍特药业有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20123049
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H20123049
Manufacturer
Chinese legal name: 成都倍特药业有限公司 (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H20123049
生产企业
成都倍特药业有限公司(国产)
适应症
本品用于酮咯酸氨丁三醇滴眼液可暂时解除季节性过敏性结膜炎所致的眼部瘙痒。亦可用于治疗白内障摘除术后的炎症。
用法用量
为解除因季节性过敏性结膜炎所致的眼部瘙痒，酮咯酸氨丁三醇滴眼液的推荐剂量是每次1滴(0.25mg)，每日4次。治疗白内障摘除术后患者的术后炎症时，应于白内障术后24小时开始。滴酮咯酸氨丁三醇滴眼液于患眼中，每次1滴，每日4次，连用两周。
不良反应
对过敏性结膜炎的患者,应用酮咯酸氨丁三醇滴眼液最常见的不良反应是在滴用时有暂时的刺痛及烧灼感。据报告,约40%使用酮略酸氨丁三醇滴眼液的患者曾出现此类反应。在各种开放式研究中,报道的在使用酮咯酸氨丁三醇滴眼液治疗期间的其他不良反应包括：眼刺激(3%),过敏反应(3%),浅层眼部感染(0.5%)及浅层角膜炎(1%)。其他少见的不良反应有：眼部干燥,角膜浸润,角膜溃疡,头痛及视物模糊。
禁忌
酮咯酸氨丁三醇滴眼液禁用于已知对此配方中的任何成份过敏的患者。
注意事项
某些非类固醇抗炎药,由于干扰血小板聚集,因而存在延长出血时间的潜在作用。曾有报道眼手术时,局部应用非类固醇抗炎药,可增加眼组织出血(包括眼前房出血)。对已知有出血倾向的患者或因接受其他可致出血时间延长的药物的患者,建议慎用酮咯酸氨丁三醇滴眼液。配戴接触镜时不得使用酮咯酸氨丁三醇滴眼液。
贮藏
密闭，在干燥处保存。
规格
5ml:25mg
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.