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  药店国别: 美国药房
产地国家: 挪威
所属类别: 神经系统药物->镇痛药
处方药:处方药
包装规格: 5毫克/毫升 100毫/ 瓶
计价单位:
  点击放大  
生产厂家英文名:
Fresenius Kabi USA, LLC
该药品相关信息网址1:
http://www.naropin-us.com/
该药品相关信息网址2:
http://www.rxlist.com/naropin-drug.htm
原产地英文商品名:
Naropin injection solution 500 mg/ 100ml 100ml/ ampule
原产地英文药品名:
Ropivacaine HCL
中文参考商品译名:
耐乐品注射液 500毫克/100毫升 100毫升/瓶
中文参考药品译名:
盐酸罗哌卡因
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Surgery Anesthesia
英文适应病症2:
Epidural anesthesia, including caesarean section
英文适应病症3:
Acute pain control
英文适应病症4:
pain after surgery or childbirth
临床试验期:
完成
中文适应病症参考翻译1:
外科手术麻醉
中文适应病症参考翻译2:
硬膜外麻醉,包括剖腹产
中文适应病症参考翻译3:
急性疼痛控制
中文适应病症参考翻译4:
术后或分娩疼痛
药品信息:
通用名: 盐酸罗哌卡因(ropivacaine hydrochloride)    商品名:耐乐品(Naropin) 药理作用:   自从发现长效局麻药可诱发心脏聚停之后,人们一直在寻求脂溶性较低的、更为安全的替代药品。罗哌卡因就是这样一种新型长效酰胺类局麻药,其作用持续时间长,且具有麻醉和止痛作用。其药理学特点为心脏毒性低微,感觉阻滞与运动阻滞分离较明显,具有外周血管收缩作用。因此该药尤其适用于术后镇痛和产科麻醉。    罗哌卡因与传统局麻药相比,具有下列优点:    1、疗效作用——罗哌卡因作用时间明显长于其它长效局麻药,皮下浸润麻醉作用时间较同浓度的布比卡因长2至3倍。    2、疗效独特——罗哌卡因的感觉—运动阻滞分离度远大于布比卡因,且清除率较高,使其更适合于镇痛。   3、可控性强——罗哌卡因的麻醉效果呈剂量依赖性,也就是说罗哌卡因产生的感觉与运动阻滞程度是可预测可控制的。    4、毒副作用低微——罗哌卡因没有一般长效局麻药的心脏毒性较大的缺点,该品极少发生心脏毒性,且胎儿对本品具良好耐受性。 【适应证】 外科手术麻醉 硬膜外麻醉,包括剖腹产 急性疼痛控制 持续硬膜外输注或间歇性单次用药,如术后或分娩疼痛 区域阻滞 【禁忌症】    对酰胺类局麻药过敏的病人禁用罗哌卡因注射液。    【注意事项】    区域麻醉的实施必须在人员和设备完善的基础上进行。用于监测和紧急复苏的药物和设备应随手可得。在实施较大麻醉前应先给病人建立静脉通路。有关临床医务人员应进行适当的培训并能熟悉副作用、全身毒性和其他并发症的诊断和治疗。    有些局部麻醉如头颈部的注射,严重不良反应的发生率较高,而与所用的局麻药无关。对于年老或伴有其它严重疾患而需施用区域麻醉的病人,应特别注意。为降低严重不良反应的潜在危险,在施行麻醉前,应尽力改善病人的状况,药物剂量也应随之调整。    由于罗哌卡因在肝脏代谢,所以严重肝病患者应慎用,由于药物排泄延迟,重复用药时需减少剂量。通常情况下肾功能不全病人如用单一剂量或短期治疗不需调整用药剂量。慢性肾功能不全患者伴有酸中毒及低蛋白血症,发生全身性中毒的可能性增大。    硬膜外麻醉会产生低血压和心动过缓,如预先输液扩容或使用血管性增压药物,可减少这一副作用的发生,低血压一旦发生可以用5-10mg麻黄素静脉注射治疗,必要时可重复用药。    【药物的相互作用】    接受其他局麻药或与酰胺类结构相关的药物治疗的病人如同时使用罗哌卡因注射液应小心谨慎,因为毒性作用是可以累加的。    【妊娠及哺乳】    妊娠:   该药对生殖的影响已在兔子和大鼠进行了试验。接受试验的两代大鼠未见生育力及一般生殖行为受药物的影响。施用最高剂量的罗哌卡因后,因其对孕母的毒性作用,产后三天内幼仔的死亡数增多,列于新生仔死亡的第二位原因。    对大鼠和兔所进行的致畸试验未见罗哌卡因对器官发生以及胎儿早期发育有任何不利影响,以最大可耐受剂量对围产期及产后的大鼠进行研究,未见其对胎儿后期发育、分娩、哺乳、新生儿生存力及子代的生长有任何影响。    另一大鼠围产期及产后的研究,将罗哌卡因与布比卡因作比较,发现在用药剂量低得多与游离血浆浓度也低的布比卡因即可观察到对孕母的毒性作用。    关于产前孕妇使用罗哌卡因后对胎儿生长的影响尚无临床试验,所以只有在对胎儿利大于弊的情况下才能让孕妇使用罗哌卡因。    分娩时使用罗哌卡因作为产科麻醉或镇痛已有充分的实验记录,未见任何副作用。    哺乳:   在人乳中罗哌卡因或其代谢物的分泌状况未曾研究。根据大鼠实验中乳汁/血浆浓度的比值,估计幼鼠日入量为其母鼠剂量的4%。假设在人类乳汁/血浆浓度比值与大鼠相同,则母乳哺育的婴儿所入罗哌卡因的量较分娩时在孕妇子宫中接受的剂量要低得多。    【对驾驶及操作机器的影响】    即使没有明显的中枢神经系统毒性,局部麻醉会轻微的影响精神状况及共济协调,还会暂时损害运动和灵活性,这些作用与剂量有关。 Common name: ropivacaine (ropivacaine hydrochloride) Product name: Le-resistant product (Naropin) ACTION: Since the discovery of long-acting local anesthetic may induce cardiac poly-stop, people have been looking for a low fat-soluble, more secure alternative to drugs. Ropivacaine is such a novel long-acting amide local anesthetic, its effects lasted for a long time, and has a narcotic and analgesic effect. Its pharmacological characteristics of cardiac toxicity was low, sensory block and motor block separation obviously, with peripheral vascular contraction. Therefore, the drug is especially suitable for postoperative analgesia and obstetric anesthesia. Ropivacaine compared with traditional local anesthetic, has the following advantages: 1, the role of efficacy - the role of ropivacaine significantly longer than other long-acting local anesthetic, subcutaneous infiltration anesthesia duration of action compared with the same concentration of bupivacaine long 2-3 times. 2, a unique effect - the feeling of ropivacaine - motor block separation is much larger than bupivacaine, and higher clearance rate, making it more suitable for analgesia. 3, controllable - the anesthetic effect of ropivacaine dose-dependent manner, the degree of sensory and motor blockade That ropivacaine produced is predictable controllable. 4, side effects humble - ropivacaine generally no greater long-acting local anesthetic cardiotoxicity shortcomings, the goods rare cardiac toxicity, and the fetus of the goods with good tolerability. [Indications] Surgery Anesthesia Epidural anesthesia, including caesarean section Acute pain control Continuous epidural infusion or intermittent single medication, such as pain after surgery or childbirth Regional anesthesia Taboos Amide local anesthetics to patients allergic to disable ropivacaine injection. [Note] Implementation of regional anesthesia must be done to improve on the basis of personnel and equipment. For monitoring and emergency resuscitation drugs and equipment should be readily available. In the implementation of a large anesthesia to patients preceded the establishment of intravenous access. Relevant clinical staff should be properly trained and familiar with the side effects, diagnosis and treatment of systemic toxicity and other complications. Some local anesthetic injection head and neck, and a higher incidence of serious adverse reactions, regardless of the local anesthetic used. For older or accompanied by other serious disorders and patients need to be administered regional anesthesia, should pay special attention. To reduce the potential risk of serious adverse reactions, in front of an anesthetic, you should try to improve the patient's condition, drug dosage should be adjusted accordingly. Since ropivacaine metabolized in the liver, so should be used with caution in patients with severe liver disease due to delayed excretion of drugs, medication should be repeated dose reduction. Under normal circumstances, patients with renal insufficiency as a single dose or short-term treatment without dose adjustment. Patients with chronic renal insufficiency acidosis and hypoproteinemia, the possibility of systemic poisoning increases. Epidural anesthesia may produce hypotension and bradycardia, such as pre-infusion expansion or vascular booster drug, can reduce the occurrence of side effects, can be used in the event of hypotension 5-10mg ephedrine intravenous treatment, if necessary can repeat medication. [Drug interactions] Patients receiving other local anesthetics or lactam structurally related drugs, such as use of ropivacaine injection should be careful, because the toxic effects are additive. [Pregnancy and lactation] Pregnancy: the impact of the drug on reproduction have been in rabbits and rats were tested. Accept no fertility tests and general reproductive behavior of two generations of rats receiving the drug. After administration of the highest dose of ropivacaine, because of its toxic effects on the pregnant mother, the number of deaths within three days postpartum pups increased, out in the second cause of newborn death. For teratogenicity test conducted in rats and rabbits no ropivacaine organogenesis and early fetal development has any adverse effects to the maximum tolerated dose of perinatal and postnatal rats were studied, and no it late fetal development, childbirth, breast-feeding, newborn offspring viability and growth have any impact. Another perinatal and postnatal study in rats, the ropivacaine and bupivacaine for comparison, found at a much lower dose and free plasma concentrations of bupivacaine low against the pregnant mother can be observed toxicity. After about prenatal maternal use of ropivacaine on fetal growth of no clinical trials affected, so only in the case of more good than harm to the fetus in pregnant women to make use of ropivacaine. Use ropivacaine during delivery of obstetric anesthesia or analgesia as there is sufficient experimental records, no any side effects. Breast-feeding: in human milk secretion status ropivacaine or lidocaine metabolite has not been studied. According to the ratio of rats in the milk / plasma concentration estimated pups daily intake for 4% of maternal dose. Assuming acceptance in the pregnant uterus at the time of human milk / plasma concentration ratio and rats are the same, that the breast-feeding infant ropivacaine were higher than the birth dose is much lower. [Effect on driving and operating machinery] Even without significant central nervous system toxicity, local anesthesia will slightly affect mental condition and Masonic coordination, will temporarily damage the movement and flexibility of these effects and dose.
更新日期: 2018-05-24
附件:
201852423294430.pdf    

 
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