Recorded Chinese product: 复方利多卡因乳膏复方利多卡因乳膏

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

利多卡因 每g本品含丙胺卡因 利多卡因是一种在国家药监局注册认定的药品。该药品含有利多卡因-c221ea43等成分。

该药品关联的活性成分包括:利多卡因Liduo Kayin。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:北京紫光制药有限公司Chinese legal name: 北京紫光制药有限公司。

您可以探索含有相同成分的其他药品:利多卡因-c221ea43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: 复方利多卡因乳膏) is a medicine registered with the national drug regulatory authority. It contains recorded ingredients as active ingredient(s).

Active ingredients associated with this product: 利多卡因Liduo Kayin.

Manufacturers recorded for this product: 北京紫光制药有限公司Chinese legal name: 北京紫光制药有限公司.

Explore other medicines containing the same ingredient: 利多卡因 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: 复方利多卡因乳膏Recorded Chinese product: 复方利多卡因乳膏
  • 剂型Dosage form: 乳膏剂Cream
  • 规格Specification: 10g10 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

  • 北京紫光制药有限公司Chinese legal name: 北京紫光制药有限公司

注册信息NMPA approval number

  • 批准文号NMPA approval number: 国药准字H20063466

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H20063466

Manufacturer

Chinese legal name: 北京紫光制药有限公司 (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

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H20063466

生产企业

北京紫光制药有限公司(国产)

适应症

本品用于下列情况的皮层局部麻醉: (1)针穿刺,如:置入导管或取血样本; (2)浅层外科手术。

用法用量

用于皮肤:在皮肤表面涂上一层厚厚的乳膏,上盖密封敷膜,成人和1岁以上的儿童大1.5g/10cm2,小手术大约2g,涂药时间至少1小时,最长5小时,大面积皮肤手术大约1.5~2g/10cm2,涂药时间至少2小时,最长5小时。3~12月婴儿在16cm2面积的皮肤最多涂用2g的乳膏,涂药时间大约1小时。生殖器粘膜:在粘膜涂本品5~10g,约5~10分钟,不需覆盖密封敷膜,即可开始手术。

不良反应

本品在应用部位可产生局部反应,以苍白、红斑(发红)和水肿较多见,这些反应多为短暂而且轻微。

禁忌

(1)对酰胺类局部麻醉药或对此产品中任何其它成份高度过敏者;
(2)先天性或特发性高铁血红蛋白血症患者。

注意事项

(1)因为没有足够的有关吸收情况的资料,本品不能用于开放性伤口,也不能用于儿童生殖器官粘膜;
(2)实验室试验结果显示本品进入中耳时有耳毒性作用,但在完整鼓膜的动物外耳道无异常发现,本品不能应用于受损的耳鼓膜;
(3)本品用于眼睛附近时应特别小心,因为它可引起角膜刺激反应;
(4)特异反应性皮炎患者使用本品时需特别小心,较短的涂用时间即可(15~30分钟);
(5)对于腿部溃疡,应消毒后使用;
(6)使用时间延长麻醉效果会减低;
(7)在得到进一步临床资料之前,本品不能应用于下列情况: 3个月以下的婴儿;正在接受高铁血红蛋白诱发剂治疗的3~12个月的婴儿。

贮藏

密封,宜置25℃以下保存,不得冷冻。

规格

10g

证据Evidence

  • 批准文号: 国药准字H20063466
  • 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.