Recorded Chinese product: 盐酸三氟拉嗪片盐酸三氟拉嗪片
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
- 广州白云山光华制药股份有限公司Chinese legal name: 广州白云山光华制药股份有限公司
主要成分Active Ingredients
- 三氟拉嗪Sanfu Laqin
药物知识说明
三氟拉嗪是一种在国家药监局注册认定的药品。标注生产企业为广州白云山光华制药股份有限公司。
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：广州白云山光华制药股份有限公司Chinese legal name: 广州白云山光华制药股份有限公司、广州白云山光华制药股份有限公司Chinese legal name: 广州白云山光华制药股份有限公司、广州白云山光华制药股份有限公司Chinese legal name: 广州白云山光华制药股份有限公司。
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: 盐酸三氟拉嗪片) is a medicine registered with the national drug regulatory authority. It is manufactured by Chinese legal name: 广州白云山光华制药股份有限公司.
No active ingredient relationships are currently recorded for this product in MedicineGraph.
Manufacturers recorded for this product: 广州白云山光华制药股份有限公司Chinese legal name: 广州白云山光华制药股份有限公司, 广州白云山光华制药股份有限公司Chinese legal name: 广州白云山光华制药股份有限公司, 广州白云山光华制药股份有限公司Chinese legal name: 广州白云山光华制药股份有限公司.
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: 盐酸三氟拉嗪片Recorded Chinese product: 盐酸三氟拉嗪片
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 5mg5 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
- 广州白云山光华制药股份有限公司Chinese legal name: 广州白云山光华制药股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H44020394
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H44020394
Manufacturer
Chinese legal name: 广州白云山光华制药股份有限公司 (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H44020394
生产企业
广州白云山光华制药股份有限公司(国产)
适应症
用于各型精神分裂症，具有振奋和激活作用，适用于紧张型的木僵症状及单纯型与慢性精神分裂症的情感淡漠及行为退缩症状。
用法用量
口服从小剂量开始，一次5mg，一日2～3次。每隔3-4日逐渐增至一次5～10mg，一日2～3次。日剂量为15～30mg，高量为一日45mg。
不良反应
锥体外系反应多见，如静坐不能、急性肌张力障碍和类帕金森病。长期大量使用可发生迟发性运动障碍。可发生心悸、失眠、乏力、口干、视物模糊、排尿困难、便秘、溢乳、男子女性化乳房、月经失调、闭经等。少见思睡、躁动、眩晕、尿潴留。偶见过敏性皮疹、白细胞减少及恶性综合征。偶可引起体位性低血压、心悸或心电图改变、肝酶水平升高或阻塞性黄疸、癫痫。
禁忌
基底神经节病变、帕金森病、帕金森综合征、骨髓抑制、青光眼、昏迷及对吩噻嗪类药过敏者。
注意事项
1、患有心血管疾病（如心衰、心肌梗死、传导异常）应慎用。 2、出现迟发性运动障碍，应停用所有的抗精神病药。 3、出现过敏性皮疹及恶性综合征应立即停药并进行相应的处理。4、肝、肾功能不全者应减量。 5、癫痫与脑器质性疾病患者慎用。6、应定期检查肝功能与白细胞计数。7、用药期间不宜驾驶车辆、操作机械或高空作业。
贮藏
遮光，密闭保存。
规格
5mg
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.