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Artcereb Perfusion Solution 20bag×500ml(电解质/葡萄糖/脑脊髓手术灌注液)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 500毫升/袋 20袋/盒 
包装规格 500毫升/袋 20袋/盒 
计价单位: 盒 
生产厂家中文参考译名:
大冢制药
生产厂家英文名:
Otsuka Pharmaceutical Factory Inc
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/3399500G1025_1_05/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
ARTCEREB(アートセレブ脳脊髄手術用洗浄灌流液)500ml/Bag 20Bag/box
原产地英文药品名:
Electrolyte, Glucose
中文参考商品译名:
ARTCEREB(アートセレブ脳脊髄手術用洗浄灌流液)500毫升/袋 20袋/盒
中文参考药品译名:
电解质/葡萄糖/脑脊髓手术灌注液
曾用名:
简介:

 

部份中文电解质/葡萄糖 /脑脊髓手术灌注溶液处方资料(仅供参考)
英文名:Electrolyte, Glucose 
商品名:Artcereb Irrigation
中文名:电解质/葡萄糖 /脑脊髓手术灌注溶液
生产商:大冢制药
药品简介
Artcereb(电解质/葡萄糖/脑脊髓手术灌注液 )是一种脑室冲洗和灌注的制剂,于2008年在日本获批上市。用于穿颅开颅手术的清洗,脊髓疾患手术的清洗和神经内镜手术的灌流,也可减少术后脑水肿的发生率
アートセレブ脳脊髄手術用洗浄灌流液
药效分类名称
脑脊髓手术用清洗·灌流液
批准日期:2008年4月
商標名
ARTCEREB Irrigation and Perfusion Solution for Cerebrospinal Surgery
一般的名称
脳脊髄手術用洗浄・灌流液
組成
该药物的上腔室液体(糖/电解质液体)和下腔室液体(电解质液体)包含以下成分。
上室液(糖、电解质液)
成分                  150ml
糖质
葡萄糖                 0.305g
电解质
氯化钠                 1.200g
氯化钙水合物           0.085g
氯化镁                 0.110g
下室液(电解质液)
成分                  350ml
电解质
碳酸氢钠               0.970g
氯化钠                 2.375g
氯化钾                 0.065g
磷酸二氢钾             0.075g
混合时
糖质
葡萄糖                 0.61g/L
电解质
Na+                    145mEq/L
K+                     2.8mEq/L
Mg2+                   2.2mEq/L
Ca2+                   2.3mEq/L
Cl-                    129mEq/L
HCO3-                  23.1mEq/L
P1.                    1mmol/L
使用注意事项
因为是液体泄漏的原因,所以要避免强烈的冲击和与尖锐的东西接触等。
为了保持品质,用气体阻隔性的外袋包装,所以在使用之前不要开封。
开封外袋前应确认指示器(二氧化碳检测剂)的颜色,紫色时不要使用。
以下情况下请勿使用。
在外袋内或容器表面发现水滴或结晶时
药液从容器泄漏时
性状及其他药液出现异状时
橡胶栓部的密封脱落时
在隔壁开通之前隔壁已经开通的情况
药效药理
作用机制
本制剂是将组成、性状近似于人的正常脑脊液的制剂,作为脑脊液手术时的清洗、灌注液使用。
对侧脑室-大槽灌注的影响
使用大鼠进行侧脑室-大槽灌注,观察脑波的结果,在生理食盐液中,所有病例都发现了突发性异常脑波,5例中有1例死亡,但本制剂中没有发现这样的异常。
对脑创伤清洗的影响
用本品对大鼠的脑创伤部位进行了4小时的清洗。比较脑组织的比重,使用本制剂时,与乳酸林格尔液及生理食盐液相比,脑浮肿的程度为轻度。从静脉内给药的埃文斯蓝向脑组织中的漏出量的比较来看,本制剂与乳酸林格尔液及生理食盐液相比,脑血管通透性的亢进较少。通过对2,3,5-triphenyltetrazolium chloride(TTC)的染色性来评价细胞损伤的程度,本制剂与乳酸林格氏液及生理盐水相比为轻度。
适应症
○穿头开颅手术时的清洗
○脊髓疾病手术时的清洗及神经内镜手术时的灌注
用法与用量
用于穿头、开颅手术时的清洗、脊髓疾病手术时的清洗以及神经内镜手术时的灌注。
用时通隔壁,将上室液和下室液充分混合。
用量通常使用适量,根据术式及手术时间等适当增减。
另外,上限量以下述为基准。
穿头开颅手术及神经内镜手术4000ml
脊髓疾病手术3000mL
临床结果
国内第Ⅲ期试验
在以102例穿头开颅手术患者及15例神经内镜手术患者为对象的国内第Ⅲ期试验5)中,手术时将本制剂作为穿头开颅手术患者的清洗液(50~8750mL)或神经内镜手术患者的灌流液(350~2980mL)使用。
在有效性分析对象病例113例(穿头开颅手术患者98例及神经内镜手术患者15例)中,对清洗液及灌流液的性能注)进行了评价,结果所有患者均为“良好”以上。
不良反应表达频率方面,穿头·开颅手术患者血中碱性磷酸酶减少2%(2/98例),神经内镜手术患者体温上升13.3%(2/15例)。
注)清洗液的性能通过术野的清洗、来自术野的空气的排除及对手术凝固装置的影响来评价,另外,通过确保清明视野、灌注液的倾斜感及对手术凝固装置的影响来评价灌注液的性能
包装
灌注液
500mL,20袋,包括软袋
制造商和销售商
大冢制药厂有限公司
销售提携
大冢制药有限公司
注:以上中文资料不够完整,使用以原处方资料为准。
完整说明资料附件:
https://www.info.pmda.go.jp/go/pack/3399500G1025_1_05/
-------------------------------------------
ARTCEREB Irrigation and Perfusion Solution for Cerebrospinal Surgery(アートセレブ脳脊髄手術用洗浄灌流液)
ARTCEREB irrigation and perfusion solution (Artcereb) is a preparation intended for the irrigation and perfusion of the cerebral ventricles。
Brand name : ARTCEREB Irrigation and Perfusion Solution for Cerebrospinal Surgery
 Active ingredient: Electrolyte, Glucose
 Dosage form: colorless and clear liquid
 Print on wrapping:
Effects of this medicine
This liquid medicine whose composition is similar to that of electrolyte of human cerebrospinal fluid ensures safe irrigation of an operative field in trephining and craniotomy, or spinal cord disease surgery, as well as perfusion of spinal fluid in endoscopic neurosurgery.
It is usually used for irrigation of an operative field in trephining and craniotomy, or spinal cord disease surgery, as well as perfusion of spinal fluid in endoscopic neurosurgery.
Before using this medicine, be sure to tell your doctor and pharmacist
If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you are pregnant or breastfeeding.
If you are taking any other medicinal products.(Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines)
Dosing schedule (How to take this medicine)
Your dosing schedule prescribed by your doctor is<<to be written by a healthcare professional>>
This medicine is usually used for irrigation of an operative field in trephining and craniotomy, or spinal cord disease surgery, as well as perfusion of spinal fluid in endoscopic neurosurgery.
Precautions while taking this medicine
Otsuka Pharmaceutical Factory Inc. Injection
Published: 12/2013
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Otsuka Pharmaceutical Factory, the new released "cleaning perfusion solution for Art celebrity brain spinal surgery" to be used as cleaning and perfusate in surgery of the brain, spinal cord from the 12th.
Cleaning and perfusion fluid is used, for example, protection of surgery at the time of blood removal and organizations. During the past brain, spinal cord surgery, mainly but saline or Ringer's lactate it has been used, because the range of surgery affect the tissues of the brain and spinal cord, the composition of the cleaning and the perfusion solution to be close to the cerebrospinal fluid it is believed to be desirable.
Art celebrity brain spinal surgery for cleaning perfusion solution, artificial cerebrospinal fluid close to the composition and properties of the normal cerebrospinal fluid of humans. As cleaning and perfusion solution used at the time of brain spinal surgery, we had to get the first efficacy and effect in the country. Adopt double bag in order to maintain the stability of the ingredients, can be sterile mixed adjusted by a simple operation.   

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