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Duaklir Pressair 400mcg/12mcg(溴化阿地溴铵和富马酸福莫特罗吸入粉末)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 400微克/12微克(60剂量)吸入粉 
包装规格 400微克/12微克(60剂量)吸入粉 
计价单位: 支 
生产厂家中文参考译名:
Circassia Pharmaceuticals plc
生产厂家英文名:
Circassia Pharmaceuticals plc
该药品相关信息网址1:
https://www.rxlist.com/duaklir-pressair-drug.htm#indications
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:
Duaklir Pressair 400mcg/12mcg(60Doses)Inhalation Powder
原产地英文药品名:
aclidinium bromide and formoterol fumarate Inhalation Powder
中文参考商品译名:
Duaklir Pressair 400微克/12微克(60剂量)吸入粉
中文参考药品译名:
溴化阿地溴铵/福莫特罗富马酸盐
曾用名:
简介:

 

部份中文溴化阿地溴铵和福莫特罗富马酸盐处方资料(仅供参考)
商品名:Duaklir Pressair
英文名:aclidinium bromide and formoterol fumarate Inhalation Powder, for Oral Inhalation
通用名:溴化阿地溴铵和富马酸福莫特罗
生产商:Circassia Pharmaceuticals plc
药品介绍:
2019年4月1日 ,美国食品和药物管理局(FDA)批准Duaklir Pressair(阿地溴铵/福莫特罗富马酸盐)吸入粉用于慢性阻塞性肺病(COPD)的维持治疗。
Duaklir Pressair结合了长效的毒蕈碱拮抗剂(LAMA)和富马酸福莫特罗(一种长效β2-肾上腺素能激动剂(LABA))的阿地溴铵。它适用于呼吸驱动的Pressair吸入器每日两次使用。

适应症
DUAKLIR PRESSAIR是阿地溴铵(一种抗胆碱能药)和福莫特罗富马酸盐(一种LABA)的组合,用于慢性阻塞性肺病(COPD)患者的维持治疗。
使用限制
DUAKLIR PRESSAIR不适用于缓解急性支气管痉挛或治疗哮喘[见警告和注意事项]。
剂量和给药
推荐剂量的DUAKLIR PRESSAIR是一次口服吸入400mcg/12 mcg,每日两次(早上一次,晚上一次)。每天两次吸入不要超过一次。
包装提供
剂型和优势
吸入粉末
DUAKLIR PRESSAIR是一种呼吸驱动的多剂量干粉吸入器,每次驱动可计量400mcg溴化阿哌啶和12mcg富马酸福莫特罗。
存储和处理
DUAKLIR PRESSAIR 400mcg/12mcg(溴化阿地溴铵和福莫特罗富马酸盐吸入粉末)在带有干燥剂袋的密封袋中提供,有60个计量剂量(NDC 72124-001-01)和30个计量剂量(NDC 72124-001) -02)。
使用多剂量干粉吸入器PRESSAIR®给予活性成分,其递送60剂量或30剂量的溴化阿地溴铵和富马酸福莫特罗粉末用于口服吸入。
PRESSAIR吸入器是一种白色和橙色的装置,由一个带有剂量指示器的组装塑料剂量机构,一个装有药品配方的药品储存单元和一个用橙色保护帽盖住的烟嘴组成。
将DUAKLIR PRESSAIR存放在干燥的地方,温度为20°C-25°C(68°F-77°F);允许偏移温度为15-30°C(59-86°F)[见USP受控室温]。不要将吸入器存放在振动表面上。
PRESSAIR吸入器应存放在密封袋内,并且只能在使用前立即打开。扔掉袋子和干燥剂小袋。
标记为“0”后丢弃(处置)PRESSAIR吸入器,红色背景显示在剂量指示器的中间,当设备为空并锁定时,或者在您打开密封袋的日期后2个月吸入器进来,以先到者为准。请将本品放在儿童不能接触的地方。
FDA Approves Duaklir Pressair (aclidinium bromide and formoterol fumarate) for Maintenance Treatment of Chronic Obstructive Pulmonary Disease
Food and Drug Administration (FDA) has approved Duaklir Pressair (aclidinium bromide, formoterol fumarate) for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
Duaklir Pressair combines aclidinium bromide, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA). It is intended for twice-daily use with the breath-actuated Pressair inhaler.
The approval was supported by data from the phase 3 ACLIFORM, AUGMENT, and AMPLIFY studies which included patients with moderate to very severe COPD. The 24-week trials eva luated the efficacy of Duaklir Pressair compared with aclidinium 400mcg, or formoterol fumarate 12mcg in nearly 5000 patients aged >40 years.
Results showed that treatment with Duaklir Pressair led to a statistically significant increase in mean change from baseline in trough FEV1 and change from baseline in 1-hour post-dose FEV1 at week 24 (co-primary endpoints) relative to formoterol fumarate 12mcg and aclidinium 400mcg, respectively.In addition, the labeling includes results from the phase 4 ASCENT study (N=3630) which eva luated aclidinium bromide in patients with moderate to very severe COPD with and without a history of exacerbations. The primary endpoint was rate of moderate to severe exacerbations during the first year of treatment, defined as worsening of COPD symptoms for at least 2 consecutive days that required treatment with antibiotics and/or systemic corticosteroids or resulted in hospitalization or death. The data showed aclidinium bromide statistically significantly reduced COPD exacerbations by 17% vs placebo (P=.003).
“With guidelines recommending combined LAMA and LABA therapy for a number of COPD patient groups, we believe Duaklir will make an important contribution to the treatment of this debilitating disease,” stated Michael Asmus, Circassia’s Vice President, US Medical Affairs.
400mcg/12mcg strength dry powder inhaler containing 30-or 60-metered doses.
 

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