Recorded Chinese product: 盐酸妥卡尼片盐酸妥卡尼片
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
- 上海信谊药厂有限公司Chinese legal name: 上海信谊药厂有限公司
主要成分Active Ingredients
- 妥卡尼Tuoka Ni
药物知识说明
妥卡尼是一种在国家药监局注册认定的药品。标注生产企业为上海信谊药厂有限公司。
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：上海信谊药厂有限公司Chinese legal name: 上海信谊药厂有限公司、上海信谊药厂有限公司Chinese legal name: 上海信谊药厂有限公司、上海信谊药厂有限公司Chinese legal name: 上海信谊药厂有限公司。
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: 盐酸妥卡尼片) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 上海信谊药厂有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
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, 上海信谊药厂有限公司Chinese legal name: 上海信谊药厂有限公司, 上海信谊药厂有限公司Chinese legal name: 上海信谊药厂有限公司.
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: 盐酸妥卡尼片Recorded Chinese product: 盐酸妥卡尼片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 0.2g0.2 g
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
- 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H31022043
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H31022043
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H31022043
生产企业
上海信谊药厂有限公司(国产)
适应症
本品用于严重的室性心律失常的治疗。包括室性早博，室性心动过速。
用法用量
口服给药： |1.一次0.2～0.4g，每8～12小时1次。或遵医嘱。 |2.先用0.4g，3～4小时后再重复一次，以后以一次0.2～0.4g，每8～12小时1次维持或遵医嘱。
不良反应
不良反应多轻微、短暂，一般不影响治疗，常见者：|1.胃肠道系统有厌食、恶心、呕吐、便秘等;|2.神经系统有眩晕、头痛、嗜睡、出汗、耳鸣、震颤等。偶见皮疹。|上述反应在停药后均可自行消失。
禁忌
1.对妥卡尼、胺酰酶类局麻药过敏者禁用。|2.未安装起博器的Ⅱ至Ⅲ度房室传导阻滞患者禁用。|3.不用于治疗有致死性室性心律失常的病人。
注意事项
1.有报道发生粒细胞缺乏，骨髓抑制，白细胞减少症，嗜中性白细胞减少症，再生障碍性贫血，血小板减少症等，多在用药12周内发生。因此建议用药三个月内每周查血常规。|2.有报道发生肺纤维化，间质性肺炎，纤维性肺泡炎，肺水肿等，多发生于重症患者，有致死报道。因此要经常做胸部X线检查。如果肺部疾病加重，要及时停药。|3.在房扑或房颤病人中应用时，该药有时可加快心室率。
贮藏
遮光，密封保存。
规格
0.2g
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.