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BRETARIS GENUAIR Inhalation powder (2018)

Active ingredients: Aclidinium bromide

Product Name and Form

Bretaris Genuair 322 micrograms inhalation powder.

Pharmaceutical form

Inhalation powder.

White or almost white powder in a white inhaler with an integral dose indicator and a green dosage button.

Qualitative and Quantitative Composition

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.

Chemical substance
Description
Aclidinium bromide

Aclidinium bromide 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 bromide acts locally in the lungs to antagonise M3 receptors of airway smooth muscle and induce bronchodilation.

List of excipients

Lactose monohydrate

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Date of first authorisation: 20 July 2012

Date of last renewal: 20 April 2017

Marketing authorization number:

EU/1/12/781/001

EU/1/12/781/002

EU/1/12/781/003