LAVENTAIR Inhalation powder, pre-dispensed Ref.[8299] Active ingredients: Umeclidinium Vilanterol

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Product name and form

LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed.

Pharmaceutical Form

Inhalation powder, pre-dispensed (inhalation powder).

White powder in a light grey inhaler (ELLIPTA) with a red mouthpiece cover and a dose counter.

Qualitative and quantitative composition

Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 65 micrograms umeclidinium bromide equivalent to 55 micrograms of umeclidinium and 22 micrograms of vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).

Excipient with known effect: Each delivered dose contains approximately 25 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.

Vilanterol

Vilanterol is a selective long-acting, beta2-adrenergic agonist (LABA). The pharmacologic effects of beta2-adrenoceptor agonist active substances, including vilanterol, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

List of Excipients

Lactose monohydrate
Magnesium stearate

Pack sizes and marketing

The ELLIPTA inhaler consists of a light grey body, red 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 two aluminium foil laminate blisters of 7 or 30 doses.

Pack sizes of 7 or 30 dose inhalers. Multipack of 3 × 30 dose inhalers.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

EU/1/14/899/001

EU/1/14/899/002

EU/1/14/899/003

Date of first authorisation: 08 May 2014

Date of latest renewal: 11 January 2019

Drugs

Drug Countries
LAVENTAIR Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.