梯瓦新药DuoResp Spiromax（budesonide & formoterol fumarate dihydrate，布地奈德+福莫特罗富马酸盐二水合物）获欧盟批准用于COPD和哮喘
2014年5月1日，梯瓦（Teva）药物DuoResp Spiromax获欧盟委员会（EC）批准，用于适合糖皮质激素和长效β2-肾上腺素受体激动剂组合疗法的慢性阻塞性肺病（COPD）和哮喘（asthma）患者的治疗。
DuoResp Spiromax（budesonide & formoterol fumarate dihydrate，布地奈德+福莫特罗富马酸盐二水合物）是一种新的多剂量干粉吸入剂，由布地奈德（budesonide）和福莫特罗（formoterol）组成。布地奈德是一种吸入性皮质类固醇（ICS），用于治疗哮喘患者和COPD患者潜在的炎症；福莫特罗是一种速效和长效β2激动剂（LABA），用于缓解哮喘患者和COPD患者的支气管收缩（bronchoconstriction ）。Spiromax吸入器采用独特的呼吸驱动技术，能够递送一致剂量的药物。
DuoResp Spiromax的开发，旨在改善药物的易用性，并递送一致剂量的药物。由于吸入器技术的落后，许多哮喘和COPD患者存在治疗不足（under-treated）的情况，这导致了额外的就诊次数以及需要紧急护理等形式的不必要负担。
DuoResp Spiromax将进入吸入性皮质类固醇/长效β2激动剂（ICS/LABA）固定剂量组合吸入剂。
DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder， 320 micrograms/9 micrograms inhalation powder
DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder
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1. Name of the medicinal product
DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
2. Qualitative and quantitative composition
Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
This is equivalent to a metered dose of 200 micrograms budesonide and 6 micrograms of formoterol fumarate dihydrate.
Excipient(s) with known effect:
Each dose contains approximately 5 milligrams of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Inhalation powder.
White powder.
White inhaler with a semi-transparent wine red mouthpiece cover.
4. Clinical particulars
4.1 Therapeutic indications
DuoResp Spiromax is indicated in adults 18 years of age and older only.
Asthma
DuoResp Spiromax is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
or
-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.
COPD
Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
4.2 Posology and method of administration
DuoResp Spiromax is indicated in adults 18 years of age and older only.
DuoResp Spiromax is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Posology
Asthma
DuoResp Spiromax is not intended for the initial management of asthma.
DuoResp Spiromax is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled short-acting β2 adrenoreceptor agonists.
The dosage of DuoResp Spiromax is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination medicinal products is initiated but also when th