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  药店国别: 英国药房
产地国家: 英国
所属类别: 神经系统药物->麻醉药
处方药:处方药
包装规格: 5克
计价单位:
  点击放大  
生产厂家英文名:
Reckitt Benckiser Healthcare
该药品相关信息网址1:
https://www.medicines.org.uk/emc/product/5938/smpc
原产地英文商品名:
LMX4, Lidocaine 4%w/w Cream 5g
原产地英文药品名:
Lidocaine
中文参考商品译名:
LMX4, 利多卡因膏 4%w/w 5克
中文参考药品译名:
利多卡因
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Local anaesthetic for topical use to produce surface anaesthesia of the skin prior
临床试验期:
完成
中文适应病症参考翻译1:
皮肤表面麻醉
药品信息:

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 详细处方信息以本药内容附件PDF文件(201910814014310.pdf)的“原文Priscribing Information”为准
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 部分中文LMX4, 利多卡因膏 4% w/w 处方资料(仅供参考)


【英文名称】
LMX4, Lidocaine 4%w/w Cream

【适用证】

在以下情况下局部麻醉以局部产生皮肤表面麻醉:

-静脉插管或静脉穿刺

-在需要使用局部麻醉剂的情况下,在完整皮肤的较大表面积上进行痛苦的局部治疗。
 

【用法用量】

仅用于皮肤。

静脉插管或静脉穿刺:

成人,包括老人和一个月以上的儿童:

在皮肤上涂抹1g至2.5g的乳霜,以覆盖2.5cm x 2.5cm(6.25cm2)的区域,在该区域会发生静脉插管或静脉穿刺。 1岁以下的婴儿应使用不超过1克的乳膏。 1g奶油相当于从5g管中挤出的奶油约5cm,或从30g管中挤出的奶油约3.5cm。

乳膏应保持不受干扰,并且该区域可以用闭塞性敷料覆盖,以防止患者干扰或干扰或其他外部因素。 30分钟后应获得足够的麻醉,但是在敷料下LMX4 Cream可以使用长达5个小时。在开始操作之前,应使用干净的纱布棉签清除LMX4 Cream,并按常规方式准备静脉插管或静脉穿刺部位。去除乳霜后应立即开始该程序。婴儿1个月至3个月的最长施用时间不应超过60分钟。 3个月至12个月婴儿的最长施用时间不应超过4小时。 12个月婴儿-成人最大使用时间不得超过5小时。

不建议将LMX4用于一个月以下的婴儿。

在完整皮肤的较大表面积上进行痛苦的局部治疗:

成人,包括老人。

以大约1.5克至2克LMX4 / 10cm2的皮肤剂量(或其倍数)施用乳霜,最大面积为900cm2。应用直至产生反应,在临床研究中通常持续30至60分钟。

通常估计的较大数量为30g-40g / 200cm2(约10cm x 20cm,或覆盖面部),45g-60g / 300cm2(约10cm x 30cm,或覆盖手臂)或135g-180g / 900cm2(约) 30cm x 30cm,或覆盖躯干或背部)。

间接证据表明,连续使用基于利多卡因的局部治疗可导致利多卡因的全身性蓄积。因此,在去除LMX4后的12个小时内不得重新使用LMX4,在任何24小时内最多可给予2剂。

LMX4乳霜应按指定剂量均匀使用,在整个局部治疗区域均匀厚度。可以采取措施确保在达到足够的止痛效果之前,乳霜保持不受干扰。

在开始操作之前,应使用干净的纱布棉签去除LMX4乳霜,并按常规方法进行局部治疗。去除乳霜后应立即开始该程序。

不建议在18岁以下的患者中使用LMX4进行此适应症。
 

【禁忌】

对活性物质或任何酰胺类局部麻醉剂或任何赋形剂过敏。
 

【 Therapeutic indications】

Local anaesthetic for topical use to produce surface anaesthesia of the skin prior to:

- venous cannulation or venipuncture

- administration of painful topical treatments on larger surface areas of intact skin where use of a topical anaesthetic is appropriate.
 

【Posology and method of administration】

For cutaneous use only.

Venous cannulation or venipuncture:

Adults, including elderly, and children over one month of age:

Apply 1g to 2.5g of cream onto the skin to cover a 2.5cm x 2.5cm (6.25cm2) area where venous cannulation or venipuncture will occur. No more than 1g of cream should be applied to infants below the age of 1 year. 1g of cream equates to approximately 5cm of cream squeezed from the 5g tube, or 3.5cm from the 30g tube.

The cream should remain undisturbed and the area can be covered with an occlusive dressing to prevent disturbance or interference by the patient or other external factors. Adequate anaesthesia should be obtained after 30 minutes, but the LMX4 Cream may be applied for up to 5 hours under a dressing. Prior to starting the procedure, the LMX4 Cream should be removed using a clean gauze swab and the site for venous cannulation or venipuncture prepared in the usual manner. The procedure should be initiated shortly after the cream has been removed. Maximum application time for 1 month up to 3 month infant should not exceed 60 minutes. Maximum application time for 3 month up to 12 month infant should not exceed 4 hours. Maximum application for 12 month infant – adult should not exceed 5 hours.

LMX4 is not recommended for use in infants under one month of age.

Painful topical treatments on larger surface areas of intact skin:

Adults, including the elderly.

Apply the cream at a dosage of approximately 1.5g to 2g LMX4 /10cm2 skin to be treated, or multiples thereof, up to a maximum area of 900cm2. Apply until a response is achieved, which is generally for between 30 to 60 minutes in clinical studies.

Typical estimated larger quantities would be 30g-40g/200cm2 (approximately 10cm x 20cm, or covering a face), 45g-60g/300cm2 (approximately 10cm x 30cm or covering an arm), or 135g-180g/900cm2 (approximately 30cm x 30cm, or covering a torso or back).

Indirect evidence has shown that successive applications of lidocaine-based topical treatments can lead to systemic accumulation of lidocaine. LMX4 must therefore not be reapplied for 12 hours following its removal, giving a maximum of 2 doses in any 24 hour period.

The LMX4 cream should be applied evenly at the specified dosage with a uniform thickness across the area where the topical treatment will occur. Measures may be taken to ensure the cream remains undisturbed until adequate analgesia has been achieved.

Prior to starting the procedure, the LMX4 Cream should be removed using a clean gauze swab and the site for topical treatment prepared in the usual manner. The procedure should be initiated shortly after the cream has been removed.

Use of LMX4 is not recommended for this indication in patients below 18 years of age.
 

【Contraindications】

Hypersensitivity to the active substance, or any of the amide-type local anaesthetics, or any of the excipients.
 

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 详细处方信息以本药内容附件PDF文件(201910814014310.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-10-8
附件:
201910814014310.pdf    

 
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