Vitamin K1 Injection (维生素K1注射液)维生素K1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
- 浙江医药股份有限公司新昌制药厂Chinese legal name: 浙江医药股份有限公司新昌制药厂
主要成分Active Ingredients
- 维生素KWeisheng Su
药物知识说明
维生素K是一种在国家药监局注册认定的药品。该药品含有维生素k-294b69e3等成分。
该药品关联的活性成分包括：维生素k。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：浙江医药股份有限公司新昌制药厂Chinese legal name: 浙江医药股份有限公司新昌制药厂。
您可以探索含有相同成分的其他药品：维生素k-294b69e3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: 维生素K1注射液) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).
Manufacturers recorded for this product: 浙江医药股份有限公司新昌制药厂Chinese legal name: 浙江医药股份有限公司新昌制药厂.
Explore other medicines containing the same ingredient: 维生素k 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: 维生素K1注射液Vitamin K1 Injection (维生素K1注射液)
- 剂型Dosage form: 注射剂Injection
- 规格Specification: 1ml:10mg1 mL:10 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
- 浙江医药股份有限公司新昌制药厂Chinese legal name: 浙江医药股份有限公司新昌制药厂
注册信息NMPA approval number
- 批准文号NMPA approval number: 国药准字H33021114
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H33021114
Manufacturer
Chinese legal name: 浙江医药股份有限公司新昌制药厂 (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H33021114
生产企业
浙江医药股份有限公司新昌制药厂(国产)
适应症
本品用于维生素K缺乏引起的出血，如梗阻性黄疸、胆瘘、慢性腹泻等所致出血，香豆素类、水杨酸钠等所致的低凝血酶原血症，新生儿出血以及长期应用广谱抗生素所致的体内维生素K缺乏。
用法用量
1.低凝血酶原血症:肌内或深部皮下注射，每次10mg，每日1～2次，24小时内总量不超过40mg。 2.预防新生儿出血:可于分娩前12～24小时给母亲肌注或缓慢静注2～5mg。也可在新生儿出生后肌内或皮下注射0.5～1mg，8小时后可重复。 3.本品用于重症患者静注时，给药速度不应超过1mg/分。
不良反应
偶见过敏反应。静注过快、超过5mg/分、可引起面部潮红、出汗、支气管痉挛、心动过速、低血压等、曾有快速静脉注射致死的报道。肌注可引起局部红肿和疼痛。新生儿应用本品后可能出现高胆红素血症、黄疸和溶血性贫血。
禁忌
严重肝脏疾患或肝功不良者禁用。
注意事项
1. 有肝功能损伤的患者、本品的疗效不明显、盲目加量可加重肝损伤。
2. 本品对肝素引起的出血倾向无效。外伤出血无必要使用本品。
3. 本品用于静脉注射宜缓慢、给药速度不应超过1mg/分。
4. 本品应避免冻结、如有油滴析出或分层则不宜使用、但可在避光条件下加热至70℃～80℃?振摇使其自然冷却、如澄明度正常则仍可继续使用。
贮藏
常温，避光贮藏。
规格
1ml:10mg
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.