Omeprazole Enteric-Coated Tablets (奥美拉唑肠溶片)奥美拉唑肠溶片
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
- 开开援生制药股份有限公司Chinese legal name: 开开援生制药股份有限公司
主要成分Active Ingredients
- 奥美拉唑omeprazole
药物知识说明
奥美拉唑是一种在国家药监局注册认定的药品。该药品含有奥美拉唑-c19b3edf等成分。
该药品关联的活性成分包括:奥美拉唑omeprazole。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:开开援生制药股份有限公司Chinese legal name: 开开援生制药股份有限公司。
您可以探索含有相同成分的其他药品:奥美拉唑-c19b3edf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
omeprazole is a medicine registered with the national drug regulatory authority. It contains omeprazole as active ingredient(s).
Active ingredients associated with this product: omeprazoleomeprazole.
Manufacturers recorded for this product: 开开援生制药股份有限公司Chinese legal name: 开开援生制药股份有限公司.
Explore other medicines containing the same ingredient: omeprazole products.
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: 奥美拉唑肠溶片Omeprazole Enteric-Coated Tablets (奥美拉唑肠溶片)
- 剂型Dosage form: 片剂Tablets
- 规格Specification: 10mg*36片10 mg × 36 tablets
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
- 开开援生制药股份有限公司Chinese legal name: 开开援生制药股份有限公司
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H19990046
关联实体Relationships
相关问题Questions
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H19990046
Manufacturer
Chinese legal name: 开开援生制药股份有限公司 (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
English translation unavailable. The original Chinese source label remains available below.
Specification
10 mg × 36 tablets
中文说明书原文Original Chinese source label
批准文号
国药准字H19990046
生产企业
开开援生制药股份有限公司(国产)
适应症
本品适用于胃溃疡、十二指肠溃疡、应激性溃疡、反流性食管炎和卓-艾综合征(胃泌素瘤)。
用法用量
口服,不可咀嚼. 1.消化性溃疡:一次20mg(1片),一日1~2次.每日晨起吞服或早晚各一次,胃溃疡疗程通常为4~8周,十二指肠溃疡疗程通常2~4周. 2.反流性食管炎:一次20~60 mg(1~。片),一日1~2次.晨起吞服或早晚各一次,疗程通常为4~8周。 3.卓-艾综合征:一次60mg(2片),一日1次,以后每日总剂量可根据病情调整为20~120mg(1~6片),若一日总剂量需超过80mg(4片)时,应分为两次服用.
不良反应
1.本品耐受性良好,常见不良反应是腹泻、头痛、恶心、腹痛、胃肠胀气及便秘,偶见血清氨基转移酶(ALT,AST)增高、皮疹、眩晕、嗜睡、失眠等,这些不良反应通常是轻微的,可自动消失,与剂量无关。
2.长期治疗未见严重的不良反应,但在有些病例中可发生胃粘膜细胞增生和萎缩性胃炎。
禁忌
对本品过敏者、严重肾功能不全者及婴幼儿禁用。
注意事项
1.治疗胃溃疡时,应首先排除溃疡型胃癌的可能,因用本品治疗可减轻其症状,从而延误治疗。
2.肝肾功能不全者慎用。
3.本品为肠溶片,服用时请注意不要嚼碎,以防止药物颗粒过早在胃内释放而影响疗效。
4.本品抑制胃酸分泌的作用强,时间长,为防止抑 酸过分,在一般消化性溃疡等病时,不建议大剂量长期应用(卓-艾氏综合征时例外)。
贮藏
遮光,密封,在阴凉(不超过20℃)干燥处保存。
规格
10mg*36片
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.