Recorded Chinese product: 酒石酸托特罗定胶囊酒石酸托特罗定胶囊
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
- 安徽环球药业股份有限公司Chinese legal name: 安徽环球药业股份有限公司
主要成分Active Ingredients
- 托特罗定Tuote Luoding
药物知识说明
托特罗定是一种在国家药监局注册认定的药品。标注生产企业为安徽环球药业股份有限公司。
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：安徽环球药业股份有限公司Chinese legal name: 安徽环球药业股份有限公司、安徽环球药业股份有限公司Chinese legal name: 安徽环球药业股份有限公司、安徽环球药业股份有限公司Chinese legal name: 安徽环球药业股份有限公司。
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: 酒石酸托特罗定胶囊) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 安徽环球药业股份有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 安徽环球药业股份有限公司Chinese legal name: 安徽环球药业股份有限公司, 安徽环球药业股份有限公司Chinese legal name: 安徽环球药业股份有限公司, 安徽环球药业股份有限公司Chinese legal name: 安徽环球药业股份有限公司.
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: 酒石酸托特罗定胶囊Recorded Chinese product: 酒石酸托特罗定胶囊
- 剂型Dosage form: 胶囊剂Capsules
- 规格Specification: 2mg2 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.
生产企业Manufacturer
- 安徽环球药业股份有限公司Chinese legal name: 安徽环球药业股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H20000603
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H20000603
Manufacturer
Chinese legal name: 安徽环球药业股份有限公司 (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
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H20000603
生产企业
安徽环球药业股份有限公司(国产)
适应症
本品适用于因膀胱过度兴奋引起的尿频、尿急或紧迫性尿失禁症状的治疗。
用法用量
给志愿者的最大剂量是单剂给予L-酒石酸托特罗定12.8mg，其最严重的不良反应是调节失调和排尿困难。在此本品过量的事件中用洗胃和给予活性炭进行治疗。
不良反应
本品的副作用一般可以耐受，停药后即可消失。本品可引起轻、中度抗胆碱能作用，如口干、消化不良和泪液减少。常见自主神经系统：口干（>1/100）胃肠系统：消化不良、便秘、腹痛、胀气、呕吐全身性：头痛眼：干眼病皮肤：皮肤干燥精神：思睡、神经质中枢神经系统：感觉异常不很常见：自主神经系统：调节失调（
禁忌
1．尿潴留、胃滞纳、未经控制的窄角型青光眼患者禁用。2．已证实对本品有过敏反应的患者禁用。3．重症肌无力患者、严重的溃疡性结肠炎患者、中毒性巨结肠患者禁用。
注意事项
1．服用本品可能引起视力模糊，用药期间驾驶车辆、开动机器和进行危险作业者应当注意。2．肝功能明显低下的患者，每次剂量不得超过半粒（1mg）。3．肾功能低下的患者、自主性神经疾病患者、裂孔疝患者慎用本品。4．由于尿潴留的风险，本品慎用于膀胱出口梗阻的病人；由于胃滞纳的风险，也慎用于患胃肠道梗阻性疾病，如幽门狭窄的患者。
贮藏
遮光，密闭保存。
规格
2mg
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.