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              BOTOX THERAPEUTIC VL 200U(肉毒毒素类型A冻干粉注射剂)
              药店国别  
              产地国家 美国 
              处 方 药: 是 
              所属类别 200单位/瓶 
              包装规格 200单位/瓶 
              计价单位: 瓶 
              生产厂家中文参考译名:
              爱立根
              生产厂家英文名:
              Allergan
              该药品相关信息网址1:
              http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=60578
              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:
              BOTOX THERAPEUTIC VL 200U DS 1
              原产地英文药品名:
              ONABOTULINUMTOXINA
              中文参考商品译名:
              BOTOX注射剂 200单位/瓶
              中文参考药品译名:
              A型肉毒毒素
              曾用名:
              简介:

               

              BOTOX(onabotulinumtoxinA)是一种神经传导的阻断剂,治疗过度活跃的肌肉。BOTOX注射作为美容材料,在亚洲年轻化注射中心主要用于瘦脸。只要将极少剂量的botox精确地注射入过于发达的脸部咬肌,使之麻痹萎缩,达到瘦脸目的。
              批准日期:2017年6月16日 公司:Allergan
              BOTOX(onabotulinumtoxinA)用于注射,肌肉注射,肌内注射或皮内注射
              最初的美国批准:1989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。
              BOTOX和所有肉毒杆菌毒素产品的效果从注射区域扩散,产生与肉毒杆菌毒素作用一致的症状。这些症状已在注射后数小时报告。吞咽和呼吸困难可能会危及生命,并且有报道称死亡。儿童因痉挛而出现症状的风险可能最大,但成人也会出现症状,特别是那些有潜在疾病的患者这会使他们容易出现这些症状。
              最近的重大变化
              剂量和用法,安全使用说明:5/2018
              作用机制
              BOTOX通过与运动或自主神经末梢上的受体位点结合,进入神经末梢和抑制乙酰胆碱的释放来阻断神经肌肉传递。这种抑制作用发生在神经毒素切割SNAP-25时,这是一种蛋白质,是成功对接和释放位于神经末梢内的囊泡中乙酰胆碱的蛋白质。当肌内注射治疗剂量时,BOTOX产生肌肉的部分化学去神经支配,导致肌肉活动的局部减少。
              此外,肌肉可能萎缩,可能发生轴突发芽,并且可能发展出额外的乙酰胆碱受体。有证据表明可能会发生肌肉的神经再支配,从而缓慢逆转BOTOX产生的肌肉去神经支配。
              当皮内注射时,BOTOX产生汗腺的暂时化学去神经支配,导致局部减少。在脉内注射后,BOTOX通过抑制乙酰胆碱释放影响逼尿肌活动的传出途径。
              适应症和用法
              BOTOX是一种乙酰胆碱释放抑制剂和神经肌肉阻滞剂,适用于:
              对对抗胆碱能神经反应有反应或不耐受的成年人,治疗具有尿失禁,尿急和尿频症状的膀胱过度活动症(OAB)。
              治疗由于逼尿肌过度活动引起的尿失禁与神经系统疾病[例如脊髓损伤(SCI),多发性硬化症(MS)]相关,对反应不良的成年人不耐受抗胆碱能药物治疗。
              成人慢性偏头痛患者的头痛预防(每月≥15天,头痛持续4小时或更长时间)
              治疗成人患者的痉挛状态。
              治疗成人患者的颈肌张力障碍,减轻头位异常和颈部疼痛的严重程度。
              治疗严重的腋窝多汗症,成人患者局部用药不足。
              治疗≥12岁患者伴有肌张力障碍的眼睑痉挛。
              治疗≥12岁患者的斜视。
              重要限制:BOTOX的安全性和有效性尚未确定:
              预防偶发性偏头痛(14天头痛或更少)。
              小儿患者上肢或下肢痉挛的治疗。
              治疗腋窝以外的身体区域的多汗症。
              剂量和给药
              遵循指示特定的剂量和给药建议;在3个月的间隔内,不要超过400单位的总剂量。
              有关注射前BOTOX重构,储存和制备的说明,请参阅制备和稀释技术。
              过度活跃的膀胱:推荐的总剂量为100单位,在进入逼尿肌的20个部位进行0.5毫升(5单位)注射。
              与神经系统疾病相关的逼尿肌过度活动:建议总剂量为200单位,在穿过30个部位进入逼尿肌的1mL(~6.7单位)注射。
              慢性偏头痛:推荐总剂量155单位,每个部位0.1mL(5单位)注射,分为7个头颈部肌肉
              上肢痉挛状态:根据受影响的肌肉选择剂量;肌肉活动的严重程度,治疗前的反应和不良事件的历史;建议使用肌电图指导。
              下肢痉挛状态:建议总剂量300单位至400单位分为踝和脚趾肌肉。
              颈部肌张力障碍:对患者的头部和颈部位置进行基础剂量给药,疼痛局部化,肌肉肥大,患者反应和不良事件;在初治的肉毒杆菌毒素患者中使用较低的初始剂量,腋窝多汗症:每腋窝50个单位。
              眼睑痉挛:1.25单位-每个受影响眼睛3个部位每个2.5个单位。
              斜视:剂量基于棱镜屈光度校正或以前用BOTOX治疗的反应。
              剂量形式和强度
              对于注射:100单位或200单位真空干燥的粉末在单剂量小瓶中。
              禁忌症
              对任何肉毒杆菌毒素制剂或制剂中的任何组分过敏。
              建议的注射部位感染。
              Intradetrusor注射:尿路感染或尿潴留。
              警告和注意事项
              BOTOX的效力单位不能与其他肉毒杆菌毒素制剂互换。
              毒素效应的传播;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。
              BOTOX注射未经批准的用途后可能出现严重不良反应。
              伴随的神经肌肉疾病可能加剧治疗的临床效果。
              呼吸功能受损患者慎用。
              BOTOX治疗眼睑痉挛可能会导致角膜暴露和溃疡减少。
              BOTOX治疗斜视可能发生球后出血和视网膜循环受损。
              痉挛性治疗患者的支气管炎和上呼吸道感染。
              接受OAB治疗的患者的尿路感染。
              尿潴留:对于OAB或逼尿肌过度活动相关的患者,应监测患者体内残余尿量与神经系统疾病相关的残留尿量
              谁不常规导尿,特别是多发性硬化症或糖尿病患者。
              不良反应
              最常见的不良反应(≥5%和>安慰剂)是:
              OAB:尿路感染,排尿困难,尿潴留与神经系统疾病相关的逼尿肌过度活动:尿路感染,尿潴留,慢性偏头痛:颈部疼痛,头痛,痉挛:四肢疼痛,颈部肌张力障碍:吞咽困难,上呼吸道感染,颈部疼痛,头痛,咳嗽加重,流感综合征,背痛,鼻炎。
              腋窝多汗症:注射部位疼痛和出血,非腋窝出汗,咽炎,流感综合征。
              要报告疑似不良反应,请致电1-800-678-1605联系Allergan或1-800-FDA-1088或www.fda.gov/medwatch联系FDA。
              药物相互作用
              接受同时治疗BOTOX和氨基糖甙类药物或干扰神经肌肉传导的患者(例如,类似于箭毒剂)的患者,或肌肉松弛剂,应密切观察,因为BOTOX的作用可能会得到充分发挥。
              用于特定人群
              怀孕:根据动物数据,可能会造成胎儿伤害。
              儿科用途:18岁以下患者预防慢性偏头痛,治疗OAB的安全性和有效性,逼尿肌过度活动与神经系统疾病,痉挛和腋下多汗症有关; 16岁以下的患者用于治疗颈肌张力障碍;而在12岁以下的患者中用于治疗眼睑痉挛和斜视。
              如何提供/存储和处理
              用于注射的BOTOX(onabotulinumtoxinA)是一种无菌的真空干燥粉末,以单剂量小瓶供应,其尺寸如下:
              100单位NDC 0023-1145-01
              200单位NDC 0023-3921-02
              BOTOX纸箱的顶部和底部襟翼有一个防篡改密封,包含半透明的银色Allergan标志,而BOTOX样品瓶标签有一个全息胶片,在彩虹色的水平线条中包含“Allergan”的名称(在你的之间旋转背面和后面)手指在台灯或荧光灯下观看全息图)。(注意:标签上的全息胶片在日期/批次区域中不存在)每个BOTOX样品瓶标签和纸箱还包含美国许可证号:1145 [见剂量和管理]。
              如果标签未在上述描述,请勿在太平洋时间上午7:00至下午3:00使用该产品并联系Allergan以获取更多信息,地址为1-800-890-4345。
              存储
              未开封的BOTOX小瓶应存放在2°至8°C(36°至46°F)的冰箱中长达36个月。在小瓶上的出汗日期之后不要使用。重组的BOTOX可以在冰箱(2°至8°C)中储存长达24小时,直至使用[见剂和管理]。
              完整资料附件:https://www.allergan.com/assets/pdf/botox_pi.pdf
              BOTOX® (onabotulinumtoxinA)&BOTOX® Cosmetic(onabotulinumtoxinA)Important
              BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
              IMPORTANT SAFETY INFORMATION
              BOTOX® and BOTOX® Cosmetic 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 BOTOX® or BOTOX® Cosmetic:
              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, and trouble swallowing.
              There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, strabismus, or when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.
              Indications
              BOTOX® is a prescription medicine that is injected into muscles and used:
              to treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
              to treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication
              to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
              to treat increased muscle stiffness in elbow, wrist, finger, thumb, ankle, and toe muscles in people 18 years and older with upper and lower limb spasticity
              to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
              to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older
              BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.
              BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows in adults.
              It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
              It is not known whether BOTOX® is safe or effective to treat increased stiffness in upper limb muscles other than those in the elbow, wrist, fingers, and thumb, or in lower limb muscles other than those in the ankle and toes. BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. Treatment with BOTOX® is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.
              It is not known whether BOTOX® and BOTOX® Cosmetic are safe or effective for other types of muscle spasms or for severe sweating anywhere other than your armpits.
              It is not known if BOTOX® Cosmetic is safe and effective for use more than 1 time every 3 months.
              BOTOX® and BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® and BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
              Do not receive BOTOX® or BOTOX® Cosmetic if you: are allergic to any of its ingredients (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
              Do not receive BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing.
              Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post-treatment, if required, should be considered for treatment.
              Patients treated for overactive bladder
              In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX® compared to 2 of the 542 treated with placebo.
              Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than non-diabetics.
              Patients treated for overactive bladder due to neurologic disease
              In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).
              Among patients not using CIC at baseline, those with MS were more likely to require CIC post-injection than those with SCI.
              The dose of BOTOX® and BOTOX® Cosmetic is not the same as, or comparable to, any other botulinum toxin product.
              Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® or BOTOX® Cosmetic should be discontinued.
              Tell your doctor 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 BOTOX® or BOTOX® Cosmetic.
              Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX® for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX®.
              Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.
              Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX®.
              Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in people receiving BOTOX® for upper limb spasticity. Upper respiratory infections were also reported more frequently in people with prior breathing related problems with spasticity.
              Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).
              Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® or BOTOX® Cosmetic can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® or BOTOX® Cosmetic passes into breast milk).
              Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® or BOTOX® Cosmetic with certain medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you received BOTOX® or BOTOX® Cosmetic in the past.
              Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic injection; take muscle relaxants; take allergy or cold medicines; take sleep medicine; take aspirin-like products or blood thinners.
              Other side effects of BOTOX® and BOTOX® Cosmetic include: dry mouth, discomfort or pain at injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of eyelids, dry eyes, and drooping eyebrows. In people being treated for urinary incontinence other side effects include: urinary tract infection, painful urination, and/or inability to empty your bladder on your own. If you have difficulty fully emptying your bladder after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.
              For more information refer to the Medication Guide or talk with your doctor.
              You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 

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