Recorded Chinese product: 盐酸乙胺丁醇胶囊盐酸乙胺丁醇胶囊
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
- 吉林万通药业集团梅河药业股份有限公司Chinese legal name: 吉林万通药业集团梅河药业股份有限公司
主要成分Active Ingredients
- 乙胺丁醇Yian Dingchun
药物知识说明
乙胺丁醇是一种在国家药监局注册认定的药品。该药品含有乙胺丁醇-04f234fe等成分。
该药品关联的活性成分包括:乙胺丁醇Yian Dingchun。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:吉林万通药业集团梅河药业股份有限公司Chinese legal name: 吉林万通药业集团梅河药业股份有限公司。
您可以探索含有相同成分的其他药品:乙胺丁醇-04f234fe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: 盐酸乙胺丁醇胶囊) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Active ingredients associated with this product: 乙胺丁醇Yian Dingchun.
Manufacturers recorded for this product: 吉林万通药业集团梅河药业股份有限公司Chinese legal name: 吉林万通药业集团梅河药业股份有限公司.
Explore other medicines containing the same ingredient: 乙胺丁醇 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: 盐酸乙胺丁醇胶囊Recorded Chinese product: 盐酸乙胺丁醇胶囊
- 剂型Dosage form: 胶囊剂Capsules
- 规格Specification: 0.25g0.25 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.
主要成分Ingredients
生产企业Manufacturer
- 吉林万通药业集团梅河药业股份有限公司Chinese legal name: 吉林万通药业集团梅河药业股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H22023685
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H22023685
Manufacturer
Chinese legal name: 吉林万通药业集团梅河药业股份有限公司 (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H22023685
生产企业
吉林万通药业集团梅河药业股份有限公司(国产)
适应症
本品适用于与其他抗结核药联合治疗结核分枝杆菌所致的肺结核和肺外结核,亦可用于非典型结核分枝杆菌感染的治疗。
用法用量
需与其他抗结核药物联合使用。|1.初治:|(1)口服,按体重15mg/kg,一日1次;或一次25~30mg/kg,最高2.5g,一周3次;|(2)或按体重50mg/kg,最高2.5g一周2次。|2.复治:口服,按体重25mg/kg,一日1次,连续60天后,继以按体重15mg/kg,一日1次。|3.非典型结核分枝杆菌感染:按体重15~25mg/kg,一日1次。
不良反应
1.常见视神经损害,如球后视神经炎,视神经中心纤维损害。|(1)可能与本品同铜,锌等金属元素螯合后引起这些金属元素含量下降有关。球后视神经炎发生率约0.8%,与剂量,疗程有关,长期服药,每日剂量大于25mg/kg时易于发生,每日剂量15mg/kg发生率为1%,25mg/kg为6%, 35mg/kg增至15%。|(2)表现为视力模糊,眼痛,红绿色盲或视力减退,视野缩小。上述反应早期发现和及时停药则可于数周或数月内自行消失,永久性视觉功能丧失极少发生。|2.少见畏寒,关节肿痛(尤其大趾,髁,膝关节)和病变关节表面皮肤发热拉紧感(急性痛风,高尿酸血症)。|3.偶见胃肠道不适,恶心,呕吐,腹泻,肝功能损害,周围神经炎(常表现为麻木,针刺感,烧灼痛或手足软弱无力)和过敏反应(常表现为皮疹,瘙痒,头痛,发热,关节痛)等。
禁忌
对本品过敏者、已知视神经炎患者、乙醇中毒者、及年龄<13岁者应谨慎使用。
注意事项
1.痛风、视神经炎、糖尿病眼底病变、肝、肾功能减退患者慎用。肾功能减退的患者应减量。|2.单用本品细菌可迅速产生耐药性,因此必须与其他抗结核药联合应用。|3.治疗期间应检查:|(1)眼部,视野、视力、红绿鉴别力等,在用药前、疗程中每月检查一次,尤其是疗程长、每日剂量超过15mg/kg的患者。|(2)由于本品可使血中尿酸浓度增高,引起痛风发作,因此在疗程中应定期测定血清尿酸。|4.对诊断的干扰、服用本品可使血尿酸浓度测定值增高。|5.如发生胃肠道刺激,本品可与食物同服。一日剂量分次服用可能达不到有效血药浓度,因此本品一日剂量宜1次服用。
贮藏
遮光,密闭保存。
规格
0.25g
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.