Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Covis Pharma Europe B.V., Gustav Mahlerplein 2, 1082MA Amsterdam, The Netherlands
Duaklir Genuair 340 micrograms/12 micrograms inhalation powder.
| Pharmaceutical Form |
|---|
|
Inhalation powder. White or almost white powder in a white inhaler with an integral dose indicator and an orange dosage button. |
Each delivered dose (the dose leaving the mouthpiece) contains 396 micrograms of aclidinium bromide (equivalent to 340 micrograms of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate. This corresponds to a metered dose of 400 micrograms of aclidinium bromide (equivalent to 343 micrograms of aclidinium) and a metered dose of 12 micrograms of formoterol fumarate dihydrate.
Excipients with known effect: Each delivered dose contains approximately 11 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Aclidinium |
Aclidinium is a competitive, selective muscarinic receptor antagonist (also known as an anticholinergic), with a longer residence time at the M3 receptors than the M2 receptors. M3 receptors mediate contraction of airway smooth muscle. Inhaled aclidinium acts locally in the lungs to antagonise M3 receptors of airway smooth muscle and induce bronchodilation. |
|
| Eformoterol |
Formoterol is a predominantly selective β2-stimulator. Formoterol has bronchodilator activity in patients with reversible obstructive airway diseases. In humans formoterol is effective in the prophylaxis of bronchospasm induced by methacholine challenge. |
|
| Formoterol and Aclidinium bromide |
Aclidinium is a long-acting muscarinic antagonist (also known as an anticholinergic) and formoterol is a long-acting β2-adrenergic agonist. The combination of these substances with different mechanisms of action results in additive efficacy compared to that achieved with either component alone. Relaxation of both central and peripheral airways with combination treatment may contribute to the beneficial effects of aclidinium/formoterol combination on lung function. |
| List of Excipients |
|---|
|
Lactose monohydrate |
The Genuair inhaler is a multicomponent device made of plastic (polycarbonate, acrylonitrilebutadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene) and stainless steel. It is white-coloured with an integral dose indicator and an orange dosage button. The mouthpiece is covered with a removable orange protective cap. The inhaler is supplied sealed in a protective aluminium laminate bag containing a silica gel desiccant sachet, placed in a cardboard carton.
Carton containing 1 inhaler with 30 doses.
Carton containing 1 inhaler with 60 doses.
Carton containing 3 inhalers each with 60 doses.
Not all pack sizes may be marketed.
Covis Pharma Europe B.V., Gustav Mahlerplein 2, 1082MA Amsterdam, The Netherlands
EU/1/14/964/001
EU/1/14/964/002
EU/1/14/964/003
Date of first authorisation: 19 November 2014
Date of latest renewal: 23 August 2019
| Drug | Countries | |
|---|---|---|
| DUAKLIR | Austria, Canada, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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