部份中文丙酸氟替卡松/富马酸福莫特罗资料（仅供参考）
商品名：Foster NEXThaler
英文名：Beclometasona dipropionato,Formoterol fumarato dihidrato
中文名：丙酸倍氯米松/富马酸福莫特罗乾粉吸入劑
劑  型：干粉吸入劑
主要成分：BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE DIHYDRATE
适应症
Foster Nexthaler适用于需规律使用吸入型皮质类固醇与长效beta 2-致效剂合并治疗的气喘病患。注意：Foster Nexthaler不宜作为气喘的第一线治疗。在以Foster Nexthaler干粉吸入剂治疗急性气喘发作的用途上，目前尚无相关临床数据
给药方法
Fostair NEXThaler的剂量为个人和应调整到该疾病的严重程度。不仅当被启动以组合产品的治疗，但也当剂量被调整这应被考虑。如果个别病人应该要求的剂量比，可以在吸入器的组合的其他的组合，适当剂量的β2-激动剂和/或皮质类固醇的个别吸入器应遵医嘱。
因为它的特细颗粒尺寸分布，当患者被转移到Fostair NEXThaler吸入粉末从制剂与非特细的粒度分布，需要调整剂量。当从以前的治疗的患者的开关，但是应当认为，推荐的总日剂量丙酸倍氯米松对Fostair NEXThaler的是低于当前倍氯米松二丙含-非特细的产品，并应调整到indivudual患者的需要。然而，谁是从Fostair加压吸入溶液转移到Fostair NEXThaler粉吸入剂的患者不需要调整剂量。
Foster NEXThaler Approved in Europe
The Chiesi Group is pleased to announce that the four decentralized procedures for the registration of Foster® NEXThaler™ have been successfully completed and approval has been granted in 14 European countries (Germany, Italy, France, Spain Austria, Belgium, Bulgaria, Greece, Hungary, Luxembourg, the Netherlands, Poland, Slovenia and Slovakia). Further approvals and an extended European roll-out in other territories are planned.
In short, doctors in the abovementioned countries will have the opportunity to prescribe a product formulated as a dry powder inhaler that, from a clinical perspective, is equivalent to the Foster pressurised metered dose inhaler (pMDI) which already forms part of the Chiesi Portfolio. This new formulation offers a high quality alternative for those doctors who prefer to prescribe their patients a powder formulation instead of a pressurised metered dose inhaler.
According to Paolo Chiesi, Vice President and R & D Director «These NEXThaler™ approvals represent the first European regulatory validation for our new inhaler technology. According to some comparative studies, it has already shown to be perceived by doctors and patients as innovative and significantly better than the dry powder inhalers currently available on the market».
The NEXThaler™ device has an intuitive and very simple 3 step inhalation sequence (OPEN-INHALE-CLOSE) and is provided with an advanced full-dose feedback system guaranteeing the complete dose is consistently released upon inhalation.
The procedures were submitted in Europe as a line extension of the pMDI formulation of Foster, already approved in 2007 by the Mutual Recognition Procedure. The pMDI is approved and successfully marketed in 55 countries and is under regulatory review in key territories outside Europe including China.
The clinical trial program for NEXThaler™ registration was extensive and involved more than 700 patients: data demonstrated an attractive safety and efficacy profile, and support the broad clinical utility of the product.
«The realization of this new product presented significant levels of complexity - said Ugo Di Francesco, CEO of the Group; for example, the development of a new generation proprietary delivery technology requires significant investment coupled with innovative thinking and technical expertise. Now, with the final regulatory approval, we can predict that the first commercial launch onto the European market will take place shortly and anticipate that it will take place in Germany».
Just like the aerosol formulation, Foster® NEXThaler™ is indicated for the regular treatment of asthma in adults where the use of a combination product between an inhaled corticosteroid and a long-acting beta2-agonist is appropriate. Similar to the currently marketed Foster® pMDI, the new Foster® NEXThaler™ releases an extra-fine particle cloud that target both the large and small airways allowing the entire bronchial tree to be treated.
«The registration of this product is a further successful achievement for our research and development team - said Alberto Chiesi, President of the Group. This landmark approval provides an impressive platform for our planned future expansion of our product portfolio in respiratory medicine».
https://www.medicines.org.uk/emc/medicine/29177