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  药店国别: 澳大利亚药房
产地国家: 澳大利亚
所属类别: 神经系统药物->麻醉药
处方药:处方药
包装规格: 50毫克 10毫升/瓶 10瓶
计价单位:
   
生产厂家英文名:
AbbVie Pty Ltd.
该药品相关信息网址1:
http://www.news-medical.net/drugs/Chirocaine.aspx
原产地英文商品名:
Chirocaine Injection amps 50mg 10ml 10amps
原产地英文药品名:
Levobupivacaine Hydrochloride
中文参考商品译名:
开洛凯因注射剂 50毫克 10毫升/瓶 10瓶
中文参考药品译名:
盐酸左布比卡因
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
anesthesia
英文适应病症2:
pain control
英文适应病症3:
Children - suitable for anesthesia
临床试验期:
完成
中文适应病症参考翻译1:
手术麻醉
中文适应病症参考翻译2:
疼痛控制
中文适应病症参考翻译3:
儿童-适用于浸润麻醉
药品信息:
药理作用 levobupivacaine属于胺基醯胺类局部麻醉剂,局部麻醉剂藉由升高神经电子兴奋的阈值、减缓神经讯号的传导和减慢动作电位上升速率的方式,以阻断神经讯号的生成及传导。一般而言,麻醉的作用与其所作用之神经直径、髓鞘及传导速率有关。临床上,神经功能丧失的顺序为 1)痛;2)温度;3)触觉;4)本体感受(proprioception);5)骨骼肌张力。 适应症 成人-手术麻醉、疼痛控制。儿童-适用于浸润麻醉(肠骨腹股沟神经、肠骨下腹神经阻断)。 用法用量 用于剖妇产部份时,最大建议剂量为150mg。 药动力学 健康自愿者投与40mg levobupivacaine后,Cmax 1.445±0.237 mcg/ml,AUC 1.153±0.447 mcg.hr/ml,t 1/2 1.27±0.37 h,Vd 66.91±18.23 l,Cl 39.06±13.29 l/h。 投与levobupivacaine后的血中浓度,除了与剂量有关,亦与投与途径有关,因为组织的血管分佈会影响投与部位的吸收。 体外试验结果发现,在浓度介于0.1至1mcg/ml之间时,大于97%与血浆蛋白结合。在浓度范围0.01-1mcg/ml时,levobupivccaine与人类血球的结合率非常低(0-2%)。在浓度为10mcg/ml时,则上升至32%。 levobupivacaine藉由CYP3A4及CYP1A2异构酵素分别代谢成desbutyl levobupivacaine及3-hydroxy levobupivacaine。活体内实验结果显示,3-hydroxy levobupivacaine会进一步与glucuronide与盐酸盐结合。 静脉注射放射线标定的levobupivacaine后,在48小时内,平均95%的量可以自尿液及粪便回收。这95%中,71%来自尿液,而24%来自粪便。血浆中放射腺活性的清除半衰期为3.3小时。静脉输注的平均廓清率及最终半衰期分别为39公升/小时即1.3小时。 副作用 低血压、搔痒症、噁心、疼痛、手术后疼痛、头痛、发烧、便秘、呕吐、头晕、贫血、胎儿窘迫。 交互作用 在已接受其他局部麻醉剂或结构相似的醯胺类麻醉剂之病人使用levobupivacaine时,应特别小心,因为这些药品所产生的毒性作用是具加成性的。体外实验结果显示,本品是藉由CYP3A4及CYP1A2代谢,因此藉由此类酵素代谢之药品与levobupivacaine併用时,可能会产生交互作用。 当与CYP3A4及CYP1A2抑制剂併用时必须调整剂量,以免levobupivacaine 全身性浓度增高进而产生毒性。 禁忌 使用任何的区域麻醉剂,包括levobupivacine时,应将与区域麻醉相关的一般禁忌也纳入考量。已知对醯胺类局部麻醉剂过敏的病人禁用levobupivacine。也禁用于静脉区域麻醉(e.q. Bier block)。此外,levobupivacine 7.5mg/ml注射剂不应使用于产科步骤,也不可使用在产科之子宫颈侧神经阻断麻醉。此使用禁忌,包括禁用于Bier block、子宫颈侧神经阻断及0.75%levobupivacaine不应使用于产科步骤,乃根据bupivacaine文献上之使用经验。levobupivacaine尚未于此类麻醉进行试验。 注意事项 有肝脏疾病之病人使用此类药品,尤其是重复投与时,应特别小心。 药品保存方式 药品应置于摄氏15 ~ 25度储存,并置于小孩不及之处;如发生变质或过期,不可再使用。 What CHIROCAINE is used for CHIROCAINE is used to anaesthetise (numb) or make free from pain, specific parts or areas of the body before minor surgery (including surgery to the eye and mouth), and major surgery (including having a baby by caesarean section). CHIROCAINE is also used to help relieve pain during labour and childbirth and after an operation. Your doctor, however, may have prescribed CHIROCAINE for another purpose. Ask your doctor if you have any questions about why CHIROCAINE has been prescribed for you. CHIROCAINE belongs to the group of medicines called local anaesthetics. These medicines work by making an area of the body numb or free from pain. CHIROCAINE is available only with a doctor's prescription. Before you are given CHIROCAINE You should not be given CHIROCAINE if: You have ever had an allergic reaction to CHIROCAINE or any other anaesthetic. Some of the symptoms of an allergic reaction may include rash, itching or hives, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty in breathing. Before you start to take or are given CHIROCAINE you must tell your doctor if 1. You are pregnant or plan to become pregnant. Your doctor will discuss the risks and benefits of receiving CHIROCAINE when pregnant; 2. You are breastfeeding or wish to breastfeed. Your doctor will discuss the risks and benefits of receiving CHIROCAINE when breastfeeding; 3. You have, or have had any medical conditions including: Kidney or liver disease Heart disease Very low blood pressure Difficulties with blood clotting Conditions affecting the nervous system (neurological problems) An electrolyte imbalance (unusual amount of salt in your body) A condition called hypoxia (lack of oxygen in your blood) 4. You are allergic to any other medicines, foods, dyes or preservatives. If you have not told your doctor or nurse about any of the above, tell them before you are given CHIROCAINE. Taking other medicines Tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop. In particular, tell your doctor if you take any of the following: Local anaesthetics or drugs that are related to amide-type local anaesthetics eg lignocaine Medicines used for epilepsy: phenytoin phenobarbitone Medicines used to treat tuberculosis rifampicin Azole antimyotics : ketoconazole Anti-HIV medicines: ritonavir Macrolide antibiotics: erythromycin clarithromycin Calcium channel antagonists: verapamil Medicines to treat stomach problems: omeprazole cimetidine Antidepressants: fluvoxamine Medicines to treat heart problems: mexilitine These medicines may affect how well CHIROCAINE works, or may be affected by CHIROCAINE. Your doctor or pharmacist can tell you what to do if you are receiving CHIROCAINE at the same time as you are taking other medicines. How CHIROCAINE is given Your doctor or nurse will administer CHIROCAINE, usually by injection through a needle or into a small tube in your back (epidural). While being given CHIROCAINE, you should drink plenty of fluids or, if you are unable to drink, your doctor will make sure that you receive plenty of fluids. Your doctor will determine how CHIROCAINE will be given and when it will be given. This may differ from the information contained in this leaflet. How much will be given? The dosage for both adults and children will depend on the condition you are being treated for, on your body weight and on your medical condition. The smallest dose that can produce an effective anaesthesia (numbing of the required area) will be used. Your doctor will adjust the amount or frequency of your doses according to the degree of numbness required. If there is something that you do not understand, please ask your doctor, pharmacist or nurse for help. If you are given too much CHIROCAINE As CHIROCAINE is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any side effects after being given CHIROCAINE tell your doctor immediately. You may need urgent medical attention.
更新日期: 2014-07-30
附件:
201473100000838.pdf    

 
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