Bretaris Genuair 322 micrograms inhalation powder.
White or almost white powder in a white inhaler with an integral dose indicator and a green dosage button.
Each delivered dose (the dose leaving the mouthpiece) contains 375 µg aclidinium bromide equivalent to 322 µg of aclidinium. This corresponds to a metered dose of 400 µg aclidinium bromide equivalent to 343 µg aclidinium.
Excipients with known effect: Each delivered dose contains approximately 12 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
The inhaler device is a multicomponent device made of polycarbonate, acrylonitrile-butadiene-styrene, polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene and stainless steel. It is white-coloured with an integral dose indicator and a green dosage button. The mouthpiece is covered with a removable green protective cap. The inhaler is supplied in a plastic laminate pouch, 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.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
Date of first authorisation: 20 July 2012
Date of last renewal: 20 April 2017