Revinty Ellipta
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
04-09-2023
Valmisteyhteenveto
(SPC)
04-09-2023
Julkisesta arviointikertomuksesta
(PAR)
17-05-2018
Aktiivinen ainesosa:
fluticasone furoate, vilanterol trifenatate
Saatavilla:
GlaxoSmithKline (Ireland) Limited
ATC-koodi:
R03AK10
INN (Kansainvälinen yleisnimi):
fluticasone furoate, vilanterol
Terapeuttinen ryhmä:
Adrenergics and other drugs for obstructive airway diseases
Terapeuttinen alue:
Asthma
Käyttöaiheet:
Asthma IndicationRevinty Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists.COPD IndicationRevinty Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1
Tuoteyhteenveto:
Revision: 22
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2014-05-02
Pakkausseloste
66
B. PACKAGE LEAFLET
67
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REVINTY ELLIPTA 92 MICROGRAMS/22 MICROGRAMS INHALATION POWDER,
PRE-DISPENSED
REVINTY ELLIPTA 184 MICROGRAMS/22 MICROGRAMS INHALATION POWDER,
PRE-DISPENSED
fluticasone furoate/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 Revinty Ellipta is and what it is used for
2.
What you need to know before you use Revinty Ellipta
3.
How to use Revinty Ellipta
4.
Possible side effects
5.
How to store Revinty Ellipta
6.
Contents of the pack and other information
Step-by-step instructions for use
1.
WHAT REVINTY ELLIPTA IS AND WHAT IT IS USED FOR
Revinty Ellipta contains two active substances: fluticasone furoate
and vilanterol. Two different
strengths of Revinty Ellipta are available: fluticasone furoate 92
micrograms/vilanterol 22 micrograms
and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.
The 92/22 micrograms strength is used for the regular treatment of
chronic obstructive pulmonary
disease (
COPD
) in adults, and
ASTHMA
in adults and adolescents 12 years and over.
The 184/22 micrograms strength is used to treat ASTHMA
in adults and adolescents aged 12 years and
older. The 184/22 micrograms strength is not approved for the
treatment of COPD.
REVINTY ELLIPTA SHOULD BE USED EVERY DAY AND NOT ONLY WHEN YOU HAVE
BREATHING PROBLEMS OR
OTHER SYMPTOMS OF COPD AND ASTHMA. IT SHOULD NOT BE USED TO RELIEVE A
SUDDEN ATTACK OF
BREATHLESSNESS OR WHEEZING
. If you get this sort of attack you must use a quick-a
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Revinty Ellipta 92 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
of fluticasone furoate and 22 micrograms of vilanterol (as
trifenatate). This corresponds to a pre-
dispensed dose of 100 micrograms of fluticasone furoate 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
White powder in a light grey inhaler (Ellipta) with a yellow
mouthpiece cover and a dose counter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Asthma
Revinty Ellipta is indicated for the regular treatment of asthma in
adults and adolescents aged 12 years
and older where use of a combination medicinal product (long-acting
beta
2
-agonist and inhaled
corticosteroid) is appropriate:
•
patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled short acting
beta
2
-agonists.
•
patients already adequately controlled on both inhaled corticosteroid
and long-acting beta
2
-agonist.
COPD (Chronic Obstructive Pulmonary Disease)
Revinty Ellipta is indicated for the symptomatic treatment of adults
with COPD with a FEV
1
<70%
predicted normal (post-bronchodilator) with an exacerbation history
despite regular bronchodilator
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Asthma _
Patients with asthma should be given the strength of Revinty Ellipta
containing the appropriate
fluticasone furoate (FF) dosage for the severity of their disease.
Prescribers should be aware that in
patients with asthma, fluticasone furoate (FF) 100 micrograms once
daily is approximately equivalent
to fluticasone propionate (FP) 250 micrograms twice daily, while FF
200 micrograms once daily is
approxima
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