活性物质 马来酸茚达特罗

通用名称：indacaterol

ATC代码：R03AC18

营销授权持有人：诺华欧洲药品有限公司

活性物质马来酸茚达特罗

状态：已授权

授权日期：2009-11-30

治疗区域：肺部疾病，慢性阻塞性疾病

药物治疗组：阻塞性气道疾病的药物

治疗指征

Oslif Breezhaler适用于维持支气管扩张剂治疗慢性阻塞性肺疾病成年患者的气流阻塞。

Oslif Breezhaler有什么用？

Oslif Breezhaler是一种药物，用于使患有慢性阻塞性肺疾病（COPD）的成年人保持气道开放。慢性阻塞性肺病是一种长期疾病，其中肺部的气道和气囊受损或阻塞，导致呼吸困难。 Oslif Breezhaler用于维持（常规）治疗。

该药物含有有效成分茚达特罗。

Oslif Breezhaler如何使用？

含有吸入粉剂的Oslif Breezhaler胶囊只能与Oslif Breezhaler吸入器一起使用，不得吞咽。为了接收剂量，患者将胶囊放入吸入器中，并通过口腔吸入粉末。

推荐剂量为一个150微克胶囊，每天一次，每天一次。严重COPD的情况下，医生可能每天将剂量增加到一粒300微克胶囊。

该药物只能通过处方获得。

Oslif Breezhaler如何工作？

Oslif Breezhaler中的活性物质indacaterol是β-2肾上腺素能受体激动剂。它通过与许多器官的肌肉细胞中发现的导致肌肉松弛的β-2受体结合而起作用。吸入Oslif Breezhaler后，茚达特罗到达气道中的受体并激活它们。这会使呼吸道的肌肉放松，有助于保持呼吸道的开放，并使患者呼吸更加轻松。

研究显示了Oslif Breezhaler有什么好处？

在涉及4,000多名COPD患者的三项主要研究中，将Oslif Breezhaler与安慰剂（一种虚拟疗法），噻托溴铵或福莫特罗（其他用于治疗COPD的吸入药物）进行了比较。有效性的主要衡量标准是基于12周后患者的强制呼气量（FEV1，一个人在一秒钟内可以呼吸的最大空气量）的变化。

Oslif Breezhaler在改善COPD患者肺部功能方面比安慰剂更有效。平均而言，接受Oslif Breezhaler治疗的患者中FEV1的增加介于150到190 ml之间，而接受安慰剂的患者中FEV1的变化从减少10 ml到增加20 ml不等。总体而言，Oslif Breezhaler的150和300毫克剂量的效果相似，但结果表明，300毫克剂量的OSLIF Breezhaler可以为病情较重的患者提供更好的缓解。噻托溴铵的FEV1增加为130 ml，福莫特罗的FEV1增加为80 ml。

Oslif Breezhaler有哪些风险？

Oslif Breezhaler的最常见副作用（可能影响超过10人中的1个人）是鼻咽炎（鼻子和喉咙发炎）和上呼吸道感染（鼻子和喉咙发炎）。其他常见的副作用包括胸痛，咳嗽和肌肉痉挛。

有关Oslif Breezhaler的所有副作用和限制的完整列表，请参阅包装传单。

为什么Oslif Breezhaler获得批准？

欧洲药品管理局的结论是，已证明Oslif Breezhaler可有效改善COPD的肺功能。原子能机构还指出，Oslif Breezhaler并没有重大安全问题，其副作用可控且类似于其他β-2肾上腺素能受体激动剂药物。因此，该机构认为Oslif Breezhaler的利益大于其风险，并建议授予其销售许可。

正在采取什么措施来确保安全有效地使用Oslif Breezhaler？

产品特性和包装手册摘要中包括了医疗专业人员和患者应遵循的有关安全有效使用Oslif Breezhaler的建议和预防措施。

有关Oslif Breezhaler的其他信息

欧盟委员会于2009年11月30日授予了在整个欧盟有效的Oslif Breezhaler营销许可。

有关使用Oslif Breezhaler进行治疗的更多信息，请阅读包装说明书（也是EPAR的一部分）或与您的医生或药剂师联系。

Active Substance: indacaterol maleate
Common Name: indacaterol
ATC Code: R03AC18
Marketing Authorisation Holder: Novartis Europharm Ltd.  
Active Substance: indacaterol maleate
Status: Authorised
Authorisation Date: 2009-11-30
Therapeutic Area: Pulmonary Disease, Chronic Obstructive
Pharmacotherapeutic Group: Drugs for obstructive airway diseases

Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Oslif Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Oslif Breezhaler is used for maintenance (regular) treatment.

The medicine contains the active substance indacaterol.

Oslif Breezhaler capsules, which contain a powder for inhalation, are only used with a Oslif Breezhaler inhaler and must not be swallowed. To receive a dose, the patient places a capsule into the inhaler and breathes the powder in through the mouth.

The recommended dose is one 150 microgram capsule, once a day at the same time each day. The doctor may increase the dose to one 300 microgram capsule once a day in cases of severe COPD.

The medicine can only be obtained with a prescription.

The active substance in Oslif Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist. It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax. When Oslif Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them. This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.

In three main studies involving over 4,000 patients with COPD, Oslif Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD). The main measure of effectiveness was based on changes in the patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks.

Oslif Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD. On average, the increase in FEV1 in patients who received Oslif Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml. Overall, the effects of the 150 and 300 microgram doses of Oslif Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease. The increase in FEV1 was 130 ml with tiotropium, and 80 ml with formoterol.

The most common side effects with Oslif Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat). Other common side effects include chest pain, cough and muscle cramps.

For the full list of all side effects and restrictions with Oslif Breezhaler, see the package leaflet.

The European Medicines Agency concluded that Oslif Breezhaler was shown to be effective at improving the lung function in COPD. The Agency also noted that there were no major safety concerns with Oslif Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines. Therefore, the Agency decided that Oslif Breezhaler’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oslif Breezhaler have been included in the summary of product characteristics and the package leaflet.

European Commission granted a marketing authorisation valid throughout the European Union for Oslif Breezhaler on 30 November 2009.

For more information about treatment with Oslif Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.