Recorded Chinese product: 甲钴胺注射液甲钴胺注射液

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

甲钴胺是一种在国家药监局注册认定的药品。该药品含有甲钴胺-bce9ee23等成分。

该药品关联的活性成分包括:甲钴胺Jiagu An。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:湘北威尔曼制药股份有限公司Chinese legal name: 湘北威尔曼制药股份有限公司。

您可以探索含有相同成分的其他药品:甲钴胺-bce9ee23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: 甲钴胺注射液) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: 甲钴胺Jiagu An.

Manufacturers recorded for this product: 湘北威尔曼制药股份有限公司Chinese legal name: 湘北威尔曼制药股份有限公司.

Explore other medicines containing the same ingredient: 甲钴胺 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: 甲钴胺注射液Recorded Chinese product: 甲钴胺注射液
  • 剂型Dosage form: 注射剂Injection
  • 规格Specification: 1ml:0.5mg1 mL:0.5 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.

主要成分Ingredients

生产企业Manufacturer

  • 湘北威尔曼制药股份有限公司Chinese legal name: 湘北威尔曼制药股份有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H20046588

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H20046588

Manufacturer

Chinese legal name: 湘北威尔曼制药股份有限公司 (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

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H20046588

生产企业

湘北威尔曼制药股份有限公司(国产)

适应症

本品用于周围神经病;因缺乏维生素B12引起的巨红细胞性贫血。

用法用量

1.周围神经病成人一次o.5mg,一日1次,一周3次,肌内注射或静脉注射,可按年龄、症状酌情增减。 2.巨幼红细胞性贫血成人一次0.5mg,一日1次,一周3次,肌内注射或静脉注射。给药约两个月后,作为维持治疗每隔1-3个月可给与一次0.5mg。

不良反应

在总病例2,872例中,13例(0.45%)出现副作用。(到再审查结束时)1. 严重副作用(频度不明)过敏症反应:会引起血压下降、呼吸困难等过敏症反应。如果出现这种副作用,应立即中止用药,并采取适当的措施。2. 其它副作用(1) 过敏:0.1%以下出现皮疹。(2) 其它:0.1%以下出现腹痛、发烧感。频度不明情况可能出现,出汗、肌内注射部位疼痛、硬结。注:如果出现这些副作用,应停止用药。

禁忌

尚不明确。

注意事项

1. 给药时见光易分解、开封后立即使用的同时、应注意避光。2. 肌肉注射时肌肉注射时为避免对组织、神经的影响、应注意如下几点:(1) 避免同一部位反复注射、且对新生儿、早产儿、婴儿、幼儿要特别小心。(2) 注意避开神经走向部位。(3) 注意针扎入时、如有剧痛、血液逆流的情况、应立即拔出针头、换部位注射。3. 安瓿打开时本品为一点折割安瓿、将安瓿的切割部位用酒精棉等擦拭后、再切割。4. 为了确保储存质量稳定、采用遮光保护袋LPE(Light Protect Easy open pack)包装、在使用时从遮光保护袋中取出。

贮藏

遮光,密封,在阴凉干燥处保存。

规格

1ml:0.5mg

证据Evidence

  • 批准文号: 国药准字H20046588
  • 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.