LAVENTAIR Inhalation powder, pre-dispensed (2019)
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Περιεχόμενα
Name of the medicinal product
LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed.
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 ...
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.
Therapeutic indications
LAVENTAIR ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Posology and method of administration
Posology Adults The recommended dose is one inhalation of LAVENTAIR ELLIPTA 55/22 micrograms once daily. LAVENTAIR ELLIPTA should be administered at the same time of the day each day to maintain bronchodilation. ...
Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Asthma Umeclidinium/vilanterol should not be used in patients with asthma since it has not been studied in this patient population. Paradoxical bronchospasm Administration of umeclidinium/vilanterol may ...
Interaction with other medicinal products and other forms of interaction
Beta-adrenergic blockers Medicinal products containing beta-adrenergic blockers may weaken or antagonise the effect of beta<sub>2</sub>-adrenergic agonists, such as vilanterol. Concurrent use of either ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of umeclidinium/vilanterol in pregnant women. Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant after administration ...
Effects on ability to drive and use machines
Umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most frequently reported adverse reaction with umeclidinium/vilanterol was nasopharyngitis (9%). Tabulated summary of adverse reactions The safety profile of LAVENTAIR ...
Overdose
An overdose of umeclidinium/vilanterol will likely produce signs and symptoms due to the individual components' actions, consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids ATC code: R03AL03 Mechanism of action ...
Pharmacokinetic properties
When umeclidinium and vilanterol were administered in combination by the inhaled route, the pharmacokinetics of each component was similar to those observed when each active substance was administered ...
Preclinical safety data
In nonclinical studies with umeclidinium and vilanterol, alone and in combination, findings were those typically associated with the primary pharmacology of either muscarinic receptor antagonists or beta ...
List of excipients
Lactose monohydrate Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years. In-use shelf-life after opening the tray: 6 weeks.
Special precautions for storage
Do not store above 30°C. If stored in a refrigerator allow the inhaler to return to room temperature for at least an hour before use. Keep the inhaler inside the sealed tray in order to protect from moisture ...
Nature and contents of container
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 ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
EU/1/14/899/001 EU/1/14/899/002 EU/1/14/899/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 08 May 2014 Date of latest renewal: 11 January 2019
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