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Dysport injection 300Units(A型肉毒毒素冻干粉注射剂)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 300单位/瓶 1瓶/盒 
包装规格 300单位/瓶 1瓶/盒 
计价单位: 盒 
生产厂家中文参考译名:
Ipsen Biopharmaceuticals Inc
生产厂家英文名:
Ipsen Biopharmaceuticals Inc
该药品相关信息网址1:
https://dysport.co
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:
Dysport injection 300units/vial 1vial/box
原产地英文药品名:
abobotulinumtoxinA
中文参考商品译名:
Dysport冻干粉注射剂 300单位/瓶 1瓶/盒
中文参考药品译名:
A型肉毒毒素
曾用名:
简介:

 

近日,美国食品药品管理局(FDA)扩大了批准使用Dysport(abobotulinumtoxinA)注射用于治疗成人痉挛,基于其下肢痉挛的补充生物学许可证申请(sBLA)。2015年7月,Dysport®获得批准用于治疗成人上肢痉挛。2016年7月,Dysport®被批准用于治疗2岁及以上的下肢痉挛患者,使其成为第一个也是唯一一个肉毒杆菌患者。
批准日期:2017年6月16日 公司:Ipsen Biopharmaceuticals Inc.
DYSPORT(abobotulinumtoxinA)用于注射,用于肌肉注射
美国最初批准:2009年
警告:
毒素效应过大
查看完整的盒装警告的完整处方信息
DYSPORT和所有肉毒杆菌毒素产品的效果可能从注射区域扩散,产生与肉毒杆菌毒素效应一致的症状。
注射后数小时至数周报告了这些症状。吞咽和呼吸困难可能会危及生命,并且有死亡报告。在因痉挛而接受治疗的儿童中,症状的风险可能最大,但成人症状可能会出现,尤其是那些患有使他们易患症状的患者。
最近的重大变化
警告和注意事项,过敏反应:9/2018
警告和注意事项,干眼症治疗GlabellarLines:9/2018
作用机制
DYSPORT抑制外周胆碱能神经末梢释放神经递质乙酰胆碱。 毒素活动发生在以下序列:毒素重链介导与神经末梢特定表面受体的结合,内化毒素通过受体介导的内吞作用,pH诱导的毒素轻链转运至细胞胞质和SNAP25的裂解导致细胞内阻断神经递质胞吐进入神经肌肉接头。这说明了治疗方法在以运动神经过度传出活动为特征的疾病中毒素的用途。随着神经肌肉接头从SNAP25裂解和新的神经末梢恢复,传递的恢复逐渐发生形成。
适应症和用法
DYSPORT是一种乙酰胆碱释放抑制剂和神经肌肉阻滞剂,适用于:
成人颈部肌张力障碍的治疗
65岁以下成人患者中度至标准线与原发性和皱眉肌活动相关的临时改善治疗成人痉挛状态
2岁及以上儿科患者下肢痉挛的治疗
剂量和给药
安全使用说明
重新配制后,将原始容器存放在2°C至8°C(36°F至46°F)的冰箱中,并在24小时内使用重建后不要冻结避光。
重建指示特定于300单位和500单位
重组DYSPORT用于肌肉注射。重建后,DYSPORT应仅用于一次注射,仅用于一名患者的颈部肌张力障碍
初始剂量为肌肉内给予500单位,作为受影响肌肉的分剂量,必要时每12至16周或更长时间再次治疗,基于临床症状的恢复,剂量在250单位和1000单位之间,以优化临床受益重复治疗不应在少于12周的间隔内进行。
根据患者的反应标记线以250单位步骤滴定
给予50单位的总剂量,分为5个相等的10个单位的等分试样,肌内注射到受影响的肌肉,以达到临床效果再治疗的频率不应超过每3个月一次。
成人痉挛状态
选择剂量基于受影响的肌肉,肌肉痉挛的严重程度,先前的反应和用DSPSP或其他肉毒杆菌毒素A治疗后的不良反应史上肢痉挛的剂量:500单位和1000单位之间
下肢痉挛剂量:最多1500单位
成人每次治疗的最大推荐总剂量(上肢和下肢组合)为1500单位基于临床症状恢复的再治疗不应该在少于12周的间隔内发生。
小儿下肢痉挛状态
根据受影响的肌肉,痉挛的严重程度和肉毒杆菌毒素的治疗史选择剂量
剂量基于单位/kg;推荐总剂量DYSPORT剂量治疗时间为每组10至15单位/kg每次治疗的总剂量单侧下肢注射不得超过15单位/kg,双侧注射30单位/kg,或1000单位,以较低者为准基于临床症状恢复的再治疗不应该在少于12周的间隔内发生。
剂量形式和强度
用于注射:300单位或500单位冻干粉末在一次性使用的小瓶中用于使用不含防腐剂的0.9%氯化钠注射剂重建,USP
禁忌症
对以下情况过敏:
任何肉毒杆菌毒素产品或赋形剂
牛奶蛋白质
建议的注射部位感染
警告和注意事项
DYSPORT的效力单位不能与其他肉毒杆菌毒素产品的制剂互换,因此,DYSPORT的生物学活性单位无法与任何其他肉毒杆菌毒素产品的单位进行比较或转换成单位在呼吸困难,言语或吞咽困难的情况下,可能需要立即就医不应超过推荐剂量和给药频率伴随的神经肌肉疾病可能加剧治疗的临床效果。
DYSPORT含有人体白蛋白。存在传播克罗伊茨费尔特-雅各布病(CJD)的风险,但是,从未发现白蛋白的病毒传播或CJD的病例
不良反应
最常见的不良反应是:颈部肌张力障碍(≥5%):肌肉无力,吞咽困难,口干,注射部位不适,疲劳,头痛,肌肉骨骼疼痛,发音困难,注射部位疼痛和眼睑疼痛Glabellar Lines(≥2%):鼻咽炎,头痛,注射部位疼痛,注射部位反应,上呼吸道感染,眼睑水肿,眼睑下垂,鼻窦炎,恶心和尿液中存在的血液水疗。
包装提供/存储和处理
注射用DYSPORT在无菌一次性玻璃瓶中提供。未开封的DYSPORT样品瓶必须在2°C至8°C(36°F至46°F)的温度下保存。避光。
请勿在样品瓶上的有效期后使用。所有样品瓶,包括过期的样品瓶,或与DYSPORT一起使用的设备都应该像对待所有医疗废物一样谨慎使用。
DYSPORT在纸箱上包含一个独特的全息图。如果您没有看到全息图,请不要使用该产品。请联系855-463-
5127。
颈椎肌张力障碍,成人痉挛和小儿患者的下肢痉挛状态
500单位小瓶
每个小瓶含有500单位的冻干的abobotulinumtoxinA。
包含1个小瓶-NDC 15054-0500-1的盒子
包含2个小瓶的盒子-NDC 15054-0500-2
300单位小瓶
每个小瓶含有300单位的冻干的abobotulinumtoxinA。
包含1个小瓶-NDC 15054-0530-6的盒子
Glabellar Lines
每个小瓶含有300单位的冻干的abobotulinumtoxinA。
包含1个小瓶的盒子-NDC 0299-5962-30
完整说明附件:https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125274s112lbl.pdf
DYSPORT(abobotulinumtoxinA) for injection, for intramuscular use
Important Safety Information
What is the most important information I should know about Dysport?
Dysport may cause serious side effects, including problems breathing or swallowing and/or spread of toxin effects, that can be life threatening and death can happen as a complication. These problems can happen within hours, or days to weeks after an injection of Dysport.
Problems swallowing, breathing, or speaking. Treatment with Dysport can result in swallowing or breathing problems. People with pre-existing swallowing or breathing problems may be at greater risk following treatment with Dysport. Swallowing problems may last for several weeks; you may need a feeding tube to receive food or water. If swallowing problems are severe, food or liquids may go into your lungs.
Spread of toxin effects. The effects of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism which include: loss of strength and muscle weakness all over the body, double or blurred vision, and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, and trouble breathing or swallowing. The risk of these symptoms is probably greatest in children treated for spasticity. These problems could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.
Call your doctor or get medical help right away if you experience these problems after treatment with Dysport.
Do not receive a Dysport injection if: you are allergic to Dysport or any of its ingredients, or cow’s milk protein; you had an allergic reaction to any other botulinum toxin product, such as Myobloc®, Botox®, or Xeomin®; or you have a skin infection at the planned injection site.
Before you receive a Dysport injection tell your doctor:
About all your medical conditions, including if you have a disease that affects your muscles and nerves (such as ALS or Lou Gehrig’s disease [amyotrophic lateral sclerosis], myasthenia gravis, or Lambert-Eaton syndrome). You may be at increased risk of serious side effects, including difficulty swallowing or breathing.
If you have or have had any of the following: a side effect from any botulinum toxin in the past; problems with breathing such as asthma or emphysema; swallowing; bleeding; diabetes; and slow heartbeat, or problems with your heart rate or rhythm.
If you have plans to have surgery, had surgery on your face, have weakness of your forehead muscles (trouble raising your eyebrows), drooping eyelids, or any other change in the way your face normally looks.
If you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Dysport can harm your unborn baby or if it passes into breast milk.
About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received Dysport in the past.
Especially tell your doctor if you have received any other injections of botulinum toxin in the last four months or ever; Myobloc®, Botox®, or Xeomin® (exactly which ones); an antibiotic recently by injection; or if you take muscle relaxants; allergy, cold or sleep medicine.
Most Common Side effects of Dysport in:
adults with upper limb spasticity include: urinary tract infection, muscle weakness, musculoskeletal pain, fall, depression, stuffy or runny nose and sore throat, and dizziness.
adults with lower limb spasticity include: muscle weakness, pain in your arms or legs, and fall.
people with cervical dystonia include: muscle weakness, dry mouth, feeling of tiredness, muscle pain, problems speaking, eye problems, difficulty swallowing, injection site pain, and headache.
children (2 to 17 years of age) with lower limb spasticity include: upper respiratory infection, stuffy or runny nose and sore throat, flu, cough, and fever.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Dysport. For more information, ask your doctor or pharmacist. You may report side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
Indication
What is Dysport?
Dysport is a prescription medicine that is injected into muscles and used to treat:
cervical dystonia (CD) in adults
increased muscle stiffness in adults with spasticity
increased muscle stiffness in children 2 years of age and older with lower limb spasticity
It is not known whether Dysport is safe or effective in children under 2 years old for the treatment of lower limb spasticity; for treating other types of muscle spasms; or for treating cervical dystonia or upper limb spasticity in children under 18 years of age. 

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