Recorded Chinese product: 普伐他汀钠片普伐他汀钠片

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

主要成分Active Ingredients

药物知识说明

普伐他汀钠是一种在国家药监局注册认定的药品。该药品含有普伐他汀钠-8bb39ced等成分。

该药品关联的活性成分包括:普伐他汀钠Pufa Tating Na。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:中美上海施贵宝制药有限公司Chinese legal name: 中美上海施贵宝制药有限公司。

您可以探索含有相同成分的其他药品:普伐他汀钠-8bb39ced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: 普伐他汀钠片) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: 普伐他汀钠Pufa Tating Na.

Manufacturers recorded for this product: 中美上海施贵宝制药有限公司Chinese legal name: 中美上海施贵宝制药有限公司.

Explore other medicines containing the same ingredient: 普伐他汀钠 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: 普伐他汀钠片Recorded Chinese product: 普伐他汀钠片
  • 剂型Dosage form: 片剂Tablets
  • 规格Specification: 20mg*5片20 mg × 5 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

  • 中美上海施贵宝制药有限公司Chinese legal name: 中美上海施贵宝制药有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H10950315

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H10950315

Manufacturer

Chinese legal name: 中美上海施贵宝制药有限公司 (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

20 mg × 5 tablets

中文说明书原文Original Chinese source label

批准文号

国药准字H10950315

生产企业

中美上海施贵宝制药有限公司(国产)

适应症

本品适用于饮食限制仍不能控制的原发性高胆固醇血症或合并有高甘油三酯三酰甘油血症患者(Ⅱa和Ⅱb型)。

用法用量

本品口服给药:成人开始剂量为10mg~20mg,一日1次,临睡前服用,一日最高剂量为40mg。

不良反应

可见轻度转氨酶升高,皮疹,肌痛,头痛,胸痛,恶心,呕吐,腹泻,疲乏等。

禁忌

1.对本品过敏者
2.活动性肝炎或肝功能试验持续升高者。
3.妊娠及哺乳期的妇女禁用。

注意事项

1.对纯合子家族性高胆固醇血症疗效差。
2.治疗期间,应定期检查肝功能,如SGPT和SGOT增高等于或超过正常上限三倍且为持续性的,应停止治疗。
3.有肝脏疾病史或饮酒史的病人应慎用本品。
4.使用HMG-CoA还原酶抑制剂类降血脂药偶可引起CPK升高,如升高值为正常上限的10倍应停止使用。使用过程中,病人如出现不明原因的肌痛、触痛、无力,特别是伴有不适和发热者,应立即报告医生。
5.其它HMG-CoA还原酶抑制剂类降血脂药与环胞霉素,纤维酸衍生物,烟酸等同时服用,可增加肌炎和肌病的发生率,但本品与上述药物同时使用,临床试验表明并不增加肌炎和肌病的发生率。

贮藏

遮光,密闭,在凉处保存。

规格

20mg*5片

证据Evidence

  • 批准文号: 国药准字H10950315
  • rights: 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。

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.