电解质/葡萄糖/脑脊髓手术灌注液(Artcereb Perfusion Solution 20bagX500ml)说明书

产地国家:日本 处 方 药: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: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   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

简介:

部份中文电解质/葡萄糖/脑脊髓手术灌注液处方资料(仅供参考)

英文名:Electrolyte, Glucose 商品名:ARTCEREB Irrigation 中文名:电解质/葡萄糖/脑脊髓手术灌注液 生产商:大冢制药 アートセレブ脳脊髄手術用洗浄灌流液 药品分类名:脑脊髓外科手术冲洗/灌注液 批准日期:2008年4月 商标:ARTCEREB Irrigation and Perfusion Solution for Cerebrospinal Surgery 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 ■上腔室液体(糖/电解液): 成分(以150毫升计): 葡萄糖:0.305克 氯化钠 :1.200克 水合氯化钙 0.085克 氯化镁 0.110克 ■下腔室液体(电解液): 成分(350mL中) 碳酸氢钠 0.970克 氯化钠 2.375克 氯化钾 0.065克 磷酸二氢钾 0.075克 ■混合时: <电解液> 钠+:145平方米/升 K +:2.8平方米/升 镁2+:2.2毫当量/升 钙+:2.3毫当量/升 氯:129平方米/升 HCO3-:23.1毫当量/升 P:1.1毫摩尔/升 <碳水化合物> 葡萄糖:0.61克/升 处理注意事项: 1.直到使用前,才应打开外袋(外层包裹有阻气膜,以防止药液的pH升高); 2.打开外袋之前,请检查指示灯的颜色,如果它是紫色的,请不要使用; 3.应在上腔室液体和下腔室液体混合时使用,或者当隔墙变白时(当隔断墙被剥离时会发白),并且变白的部分通向两个腔室; 4.将引入针直接插入橡胶塞的大孔中; 5.请勿使用在包装中发现有水滴或液体内容物变色或混浊的产品; 6.使用容器上的秤作为粗略的指导。 药效与药理: 药理学 使用大鼠进行侧脑室灌注后,观察到脑电图,结果生理盐水均显示突然异常脑电图,每5例中有1例死亡。 用该产品洗涤大鼠脑伤口4小时。当比较脑组织的比重时,与使用林格氏乳酸盐溶液和生理盐水溶液相比,该药物的脑水肿程度更轻。通过比较泄漏到脑组织的静脉注射伊文思蓝的量,该产品显示出比林格氏乳酸盐溶液和生理盐水溶液低的脑血管通透性。通过对2,3,5-三苯基四唑氯化物(TTC)染色评估细胞毒性程度时,该药物比林格氏乳酸溶液和生理盐溶液温和) 适应症: 开颅手术和开颅手术中的冲洗,脊髓手术中的冲洗和神经内镜手术中的灌注。 用法与用量: 它用于开颅手术和开颅手术中的灌洗,脊髓手术中的灌洗以及神经内窥镜手术中的灌洗。 在使用时,打开隔板以混合上腔室液体和下腔室液体。 通常使用的量是适当的量,并且可以根据操作方法和操作时间适当地增加或减少。 上限如下。 开颅手术/开颅手术和神经内窥镜手术:4000毫升 脊髓手术:3000毫升 临床结果:以下是在全国17个机构中对总共157例接受开颅/开颅手术和神经内镜手术的患者进行的临床试验的总结。 (1)II期临床试验) 对总共44例患者进行了临床研究,其中40例接受了开颅手术和开颅手术,还有4例接受了神经内窥镜手术。根据术后并发症(不良事件)作为疗效评估临床结果的结果,在发生的任何术后并发症中均未发现与研究药物有因果关系。另外,通过评估洗涤溶液和灌注液的性能是否存在问题的结果,证实了在任何性能上均没有问题。 (2)III期临床试验) 对总共113例患者,98例行开颅/开颅手术和15例行神经内窥镜手术的患者进行了临床研究,评估了灌洗液和灌注液的性能。对于冲洗液的评价,作为评价手术部位的冲洗,从手术部位除去空气以及对手术用凝结剂的性能的影响的结果,没有问题,“良好”为100%。 关于灌注液的评估,评估结果以确保清晰的视野,评估灌注液的粘性和对手术凝血装置的影响作为性能。 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 注:以上中文资料不够完整,使用以原处方资料为准。

英文说明书

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<> 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:  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.
用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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