Trelegy Ellipta
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
30-10-2023
Produktets egenskaber
(SPC)
30-10-2023
Offentlige vurderingsrapport
(PAR)
04-01-2019
Aktiv bestanddel:
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
Tilgængelig fra:
GlaxoSmithKline Trading Services
ATC-kode:
R03AL08
INN (International Name):
fluticasone furoate, umeclidinium, vilanterol
Terapeutisk gruppe:
Drugs for obstructive airway diseases,
Terapeutisk område:
Pulmonary Disease, Chronic Obstructive
Terapeutiske indikationer:
Trelegy Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist.
Produkt oversigt:
Revision: 11
Autorisation status:
Authorised
Autorisation dato:
2017-11-15
Indlægsseddel
32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRELEGY ELLIPTA 92 MICROGRAMS/55 MICROGRAMS/22 MICROGRAMS INHALATION
POWDER, PRE-DISPENSED
fluticasone furoate/umeclidinium/vilanterol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Trelegy Ellipta is and what it is used for
2.
What you need to know before you use Trelegy Ellipta
3.
How to use Trelegy Ellipta
4.
Possible side effects
5.
How to store Trelegy Ellipta
6.
Contents of the pack and other information
Step-by-step instructions
1.
WHAT TRELEGY ELLIPTA IS AND WHAT IT IS USED FOR
WHAT TRELEGY ELLIPTA IS
Trelegy Ellipta contains three active substances called fluticasone
furoate, umeclidinium bromide and
vilanterol. Fluticasone furoate belongs to a group of medicines called
corticosteroids, often simply called
steroids. Umeclidinium bromide and vilanterol belong to a group of
medicines called bronchodilators.
WHAT TRELEGY ELLIPTA IS USED FOR
Trelegy Ellipta is used to treat chronic obstructive pulmonary disease
_ _
(
COPD
) in adults. COPD is a long-
term condition characterised by breathing difficulties that slowly get
worse.
In COPD the muscles around the airways tighten, making breathing
difficult. This medicine widens these
muscles in the lungs, reducing the swelling and irritation in the
small air passages and making it easier for air
to get in and out of the lungs. When used regularly, it can help to
control your breathing difficulties and
reduce the effects of COPD on your everyday life.
TRELEGY ELLIP
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation
powder, pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 92 micrograms
fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to
55 micrograms umeclidinium and
22 micrograms vilanterol (as trifenatate). This corresponds to a
pre-dispensed dose of 100 micrograms
fluticasone furoate, 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
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed (inhalation powder)
White powder in a light grey inhaler (Ellipta) with a beige mouthpiece
cover and a dose counter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trelegy Ellipta is indicated as a maintenance treatment in adult
patients with moderate to severe chronic
obstructive pulmonary disease (COPD) who are not adequately treated by
a combination of an inhaled
corticosteroid and a long-acting β2-agonist or a combination of a
long-acting β2-agonist and a long-acting
muscarinic antagonist (for effects on symptom control and prevention
of exacerbations see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
The recommended and maximum dose is one inhalation once daily, each
day at the same time.
If a dose is missed the next dose should be inhaled at the usual time
the next day.
_Special populations _
_Elderly_
No dose adjustment is required in patients 65 years of age or older
(see section 5.2).
_Renal impairment _
No dose adjustment is required in patients with renal impairment (see
section 5.2).
3
_Hepatic impairment _
No dose adjustment is required in patients with mild, moderate or
severe hepatic impairment. Trelegy Ellipta
sh
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