Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed.
| Pharmaceutical Form |
|---|
|
Inhalation powder, pre-dispensed (inhalation powder). White powder in a grey inhaler (Ellipta) with a light green mouthpiece cover and a dose counter. |
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide.
Excipient with known effect: Each delivered dose contains approximately 12.5 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Umeclidinium |
Umeclidinium is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic). It is a quinuclidine derivative that is a muscarinic receptor antagonist with activity across multiple muscarinic cholinergic receptor subtypes. Umeclidinium bromide exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic cholinergic receptors on airway smooth muscle. |
| List of Excipients |
|---|
|
Lactose monohydrate |
The Ellipta inhaler consists of a grey body, light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet. The tray is sealed with a peelable foil lid.
The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
The inhaler contains one aluminium foil laminate blister of 7 or 30 doses.
Pack sizes of 7 and 30 dose inhaler.
Multipacks containing 90 (3 inhalers of 30) doses.
Not all pack sizes may be marketed.
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
EU/1/14/922/001
EU/1/14/922/002
EU/1/14/922/003
Date of first authorisation: 28 April 2014
Date of latest renewal: 11 January 2019
| Drug | Countries | |
|---|---|---|
| INCRUSE | Austria, Australia, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, United States |
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