产地国家：美国 处 方 药：是 所属类别：100单位/瓶 包装规格：100单位/瓶 计价单位：瓶 生产厂家中文参考译名：Evolus, Inc. 生产厂家英文名：Evolus, Inc. 原产地英文商品名：jeuveau injection 100UI/vial 原产地英文药品名：prabotulinumtoxinA-xvfs 中文参考商品译名：jeuveau注射用粉末 100单位/瓶 中文参考药品译名：肉毒杆菌

简介

近日，美国食品和药物管理局(FDA)已批准其先导产品Jeuveau(prabotulinumtoxinA-xvfs)用于成人，暂时改善与皱眉肌和/或降眉间肌活动相关的中度至重度皱眉纹(glabellar lines)的外观。 Evolus总裁兼首席执行官David Moatazedi表示，“Evolus是近十年来第一家进入快速增长的美国美学神经毒素市场的公司。让Evolus与众不同的是，专注于以客户为中心的方式提供高性能美            容产品。我们很高兴推出Jeuveau，这是首个经FDA批准的专门用于美学的神经毒素，采用Hi-Pure技术并根据严格的质量和安全标准在最先进的设施中生产。” Jeuveau是一种注射型900千道尔顿(kDa)肉毒杆菌A型肉毒毒素，旨在满足日益增长的面部美容市场的需求。Evolus认为，Jeuveau将为医师和患者提供一个非常有吸引力的治疗选择。 批准日期：2019年2月1日 公司：Evolus, Inc. 美国初步批准：2019年 警告：毒素远距离传播 有关完整的盒装警告，请参阅完整的处方信息。所有肉毒杆菌毒素产物，包括肉毒杆菌，可能会从注射区域扩散，产生与肉毒杆菌毒素效应一致的症状。这些症状在注射后数小时到数周内报              告。吞咽和呼吸困难可能危及生命，有死亡报告。Jeuveau不被批准用于治疗痉挛或除格拉贝拉线以外的任何病症。[见警告和注意事项] 作用机制 阻塞神经传动，通过与接受地点的电动机神经终端，掩埋神经终端。抑制乙酰胆碱释放本发明的抑制作用是神经毒剂清洗剂- 25，一种蛋白质积分。并释放乙酰胆碱从血管内脏中的位置。在热          血剂量内注射肌肉的时候产生于肌肉活化中的肌肉凝固的部分化学密度。在加法中，肌肉可能会萎缩，肾上腺癌可以占据，外外侧的乙酰胆碱受体可以提高。有明显的证据表明，肌肉占据了肌          肉的染色体。 适应症和使用 Jeuveau是一种乙酰胆碱释放抑制剂和一种神经肌肉阻滞剂，用于暂时改善中度到重度后玻璃体相关系的外观。有皱眉肌和/或直肠肌肉活动不正常的患者 剂量和给药 格拉贝拉线给药：每5个部位肌肉注射0.1毫升(4单位)，总剂量20单位。 剂型及强度 注射用：100单位真空干燥粉末 单剂量药瓶 禁忌症 •对肉毒杆菌毒素修复或形成过程中的任何成分过敏 •注射部位感染 警告和注意事项 •Jeuveau的效价单位不能与肉毒杆菌毒素产品的其他制剂互换。 •毒素效应扩散;吞咽和呼吸困难可导致死亡。如果出现呼吸、言语或吞咽困难，请立即就医。 未经批准使用的Jeuveau注射后的潜在严重不良反应 •心血管系统已收到不良事件报告，其中一些有致命后果。对已有心血管疾病的患者进行治疗时要小心。 疾病 •伴随的神经肌肉疾病可能加剧治疗的临床效果。 •对呼吸功能受损或吞咽困难的患者慎用 不良反应 最常见的不良反应是： •头痛(9.3%) •眼睑下垂(2%) 上呼吸道感染(3%) •增加白细胞计数(1%) 药物相互作用 同时接受Jeuveau和氨基糖苷类药物治疗或其他干预神经肌肉传导的药物(如箭毒类药物)或肌肉松弛剂治疗的患者应 仔细观察，因为葡萄酒的效果可能会增强。 包装供应/储存和搬运 注射用Jeuveau(Prabotulinumtoxina xvfs)是一种真空干燥粉末，以单剂量小瓶供应，大小如下： 100单位(NDC 72301-595-10) 保管部 未开封的葡萄酒瓶应存放在2°C至8°C(36°F至46°F)的冰箱中，放在原纸箱中，以防光线照射。

英文版说明书

Evolus Receives FDA Approval for Jeuveau(TM) prabotulinumtoxinA-xvfs for Injection U.S. Food and Drug Administration ("FDA") has approved its lead product, Jeuveau(TM), for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults. IMPORTANT SAFETY INFORMATION FOR JEUVEAU(TM) (prabotulinumtoxinA-xvfs) JEUVEAU may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of JEUVEAU: Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months. Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing. Do not use JEUVEAU if you: are allergic to any of the ingredients in JEUVEAU (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC(R)), onabotulinumtoxinA (BOTOX(R)/BOTOX(R) Cosmetic), abobotulinumtoxinA (DYSPORT(R)), or incobotulinumtoxinA (XEOMIN(R)); have a skin infection at the planned injection site; or are a child. Jeuveau dosing units are not the same as, or comparable to, any other botulinum. Tell your healthcare provider about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, Myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of JEUVEAU. Tell your healthcare provider about all your medical conditions, including: any side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles; drooping eyelids; had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed (it is not known if JEUVEAU can harm your unborn baby or passes into breast milk). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using JEUVEAU with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received JEUVEAU in the past. Especially tell your healthcare provider if you: have received any other botulinum toxin product in the past and the last 4 months. and exactly which product you received (such as Botox, Botox Cosmetic, Myobloc, Dysport, or Xeomin). JEUVEAU may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of treatment with JEUVEAU. If this happens, do not drive a car, operate machinery, or do other dangerous activities. JEUVEAU can cause other serious side effects including: allergic reactions (such as itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint), heart problems (such as irregular heartbeat and heart attack), and eye problems (including dry eye, reduced blinking, and corneal problems). Tell your healthcare provider or get medical emergency help right away if you experience a serious side effect. The most common side effects include: headache; eyelid drooping, upper respiratory tract infection, and increased white blood cell count in your blood. APPROVED USE JEUVEAU is a prescription medicine that is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).