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  药店国别: 美国药房
产地国家: 美国
所属类别: 作用于呼吸系统药物->哮喘药物
处方药:处方药
包装规格: (200微克/5微克)/吸入剂 120吸入剂/HFA气雾剂
计价单位:
   
生产厂家英文名:
Merck
该药品相关信息网址1:
http://dulera.com/mometasone_formoterol/dulera/consumer/what_is_dulera.jsp?src=sem&WT.mc_id=DU067&MTD=2&CPN=2&ENG=1&TERM=9&utm_source=google&utm_medium=cpc&utm_term=dulera&utm_campaign=Branded+10%2F11&utm_content=s8Vu9S5x4|dc_pcrid_60059097001&gclid=CKzC2
该药品相关信息网址2:
http://www.webmd.com/drugs/2/drug-154346/dulera-inhalation/details
原产地英文商品名:
Dulera (200mcg / 5mcg) Inhaler 120 Inhalation. Pack Size: 1 Unit HFA Aerosol AD.
原产地英文药品名:
(Mometasone Furoate / Formoterol Fumarate)
中文参考商品译名:
Dulera (200微克/5微克)/吸入剂 120吸入剂/HFA气雾剂
中文参考药品译名:
复合糠酸莫米松&福莫特罗富马酸吸入剂
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Asthma
临床试验期:

中文适应病症参考翻译1:
哮喘
药品信息:
2010年6月24日,默克公司宣布,美国FDA已批准其固定剂量抗哮喘复方吸入剂糠酸莫米松+富马酸福莫特罗(mometasone furoate+formoterol fumarate,Dulera)用于12岁及以上患者持续性哮喘的控制。本品是一个糖皮质激素+长效β2受体激动剂的复方药物。 (莫米松/福莫特罗)喷雾剂以压力定量吸入器的形式包装分发,其内置一个数字计数器,可显示剩余的剂数。两剂的复合制剂Duraler预期于2010年7月底在零售药房出售。每剂含5μg富马酸福莫特罗和100μg或200μg糠酸莫米松。建议开始剂量是根据先前的哮喘治疗设定的。每日最大建议剂量为(莫米松/福莫特罗)喷雾剂200μg/5μg,每日早晚各吸入1次。 FDA批准(莫米松/福莫特罗)喷雾剂部分基于两项随机临床试验(试验1和试验2)的数据。这两项试验历时12-26周,总共涉及1,509例12岁及12岁以上、服用中、高剂量吸入性皮质类固醇后病情未得到控制的持续性哮喘患者。这两项研究包括2~3周导入期,期间受试者接受糠酸莫米松治疗,使哮喘控制在某种水平。 试验1将(莫米松/福莫特罗)喷雾剂100μg/5μg治疗组(n=191)与该药单独组分糠酸莫米松100μg治疗组(n=192)、福莫特罗5μg治疗组(n=202)及安慰剂对照组(n=196)进行比较。试验2将(莫米松/福莫特罗)喷雾剂200μg/5μg治疗组(n=255)与(莫米松/福莫特罗)喷雾剂100μg/5μg治疗组(n=233)以及富马酸福莫特罗200μg治疗组(n=240)进行比较。所有的药物均通过定量吸入器给药,1天吸入2剂。 两项临床试验结果表明,与糠酸莫米松治疗组患者(试验1)和安慰剂对照组患者(试验2)相比,(莫米松/福莫特罗)喷雾剂(100μg/5μg或200μg/5μg)治疗组患者在12周时肺功能较基线获得显著改善。在试验1中,上述差异一直维持至第26周。 试验受试者中最常见的治疗相关的不良事件为鼻咽炎、鼻窦炎和头痛。在被分配至药物治疗组的患者中,这些不良事件的报告发生率≥3%,高于安慰剂对照组。临床试验中(莫米松/福莫特罗)喷雾剂100μg/5μg治疗组患者口腔念珠菌感染的报告发生率为0.7%,而(莫米松/福莫特罗)喷雾剂200μg/5μg治疗组为0.8%,安慰剂对照组为0.5%。 默克研究室,全球科学事务执行董事JamesE.Fish博士表示:“默克公司是研发哮喘药乃至呼吸道系统药物的领航者,一直致力于满足病患的需要,此次开发上市的(莫米松/福莫特罗)喷雾剂是我们的重要成果之一。 What is DULERA (mometasone furoate and formoterol fumarate dihydrate)? DULERA is an inhaled medicine used to control and prevent asthma symptoms such as wheezing in people 12 and older. DULERA is not a rescue inhaler and should not be used as a treatment for sudden asthma symptoms. DULERA is not for people who are well controlled on a long-term asthma-control medicine like a low to medium dose of an inhaled corticosteroid medicine, or who only need a rescue inhaler once in a while. Selected Important Safety Information about DULERA People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in DULERA), have an increased risk of death from asthma problems. It is not known whether mometasone furoate, the other medicine in DULERA, reduces the risk of death from asthma problems seen with formoterol. Call your healthcare provider if breathing problems worsen over time while using DULERA. You may need different treatment. Get emergency medical care if breathing problems worsen quickly, and you use your rescue inhaler medicine, but it does not relieve your breathing problems. DULERA should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma-control medicine, such as an inhaled corticosteroid. When your asthma is well controlled, your healthcare provider may tell you to stop taking DULERA. Your healthcare provider will decide if you can stop DULERA without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems. DULERA does not replace rescue inhalers for sudden asthma symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms. Do not use DULERA more often than prescribed. Do not take DULERA with other medicines that contain a LABA for any reason, as using too much LABA may cause chest pain, increase or decrease in blood pressure, fast and irregular heartbeat, headache, tremor, nervousness, dizziness, weakness, seizures and electrocardiogram (ECG) changes. Tell your doctor about medicines you take and about all of your medical conditions. People taking DULERA may experience Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of these symptoms of a serious allergic reaction: rash, hives, swelling, including swelling of the face, mouth and tongue, or breathing problems. Thrush (yeast infection) in the mouth and throat. A higher chance of infection. Avoid exposure to chickenpox or measles. If exposed, or if you have any signs of infection, tell your healthcare provider immediately. Worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex may occur. Reduced adrenal function (may result in loss of energy). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines. Increase in wheezing right after taking DULERA. Lower bone mineral density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis). Slowed growth in children. Eye problems including glaucoma and cataracts. You should have regular eye exams while using DULERA. Decrease in blood potassium and increase in blood sugar levels. If you are switching to DULERA from an oral corticosteroid, follow your healthcare provider's instructions to avoid serious health risks when you stop using oral corticosteroids. The most common side effects of DULERA include inflammation of the nose and throat, inflammation of the sinuses, and headache.
更新日期: 2014-11-23
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