Temybric Ellipta

País: União Europeia

Língua: inglês

Origem: EMA (European Medicines Agency)

Ingredientes ativos:

fluticasone furoate, umeclidinium bromide, vilanterol trifenatate

Disponível em:

GlaxoSmithKline Trading Services Limited

Código ATC:

R03AL08

DCI (Denominação Comum Internacional):

fluticasone furoate, umeclidinium, vilanterol

Grupo terapêutico:

Drugs for obstructive airway diseases,

Área terapêutica:

Pulmonary Disease, Chronic Obstructive

Indicações terapêuticas:

Temybric 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).

Resumo do produto:

Revision: 4

Status de autorização:

Withdrawn

Data de autorização:

2019-06-12

Folheto informativo - Bula

32
B. PACKAGE LEAFLET
Medicinal product no longer authorised
33
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TEMYBRIC ELLIPTA 92 MICROGRAMS/55 MICROGRAMS/22 MICROGRAMS INHALATION
POWDER, PRE-DISPENSED
fluticasone furoate/umeclidinium/vilanterol
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
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 Temybric Ellipta is and what it is used for
2.
What you need to know before you use Temybric Ellipta
3.
How to use Temybric Ellipta
4.
Possible side effects
5.
How to store Temybric Ellipta
6.
Contents of the pack and other information
Step-by-step instructions
1.
WHAT TEMYBRIC ELLIPTA IS AND WHAT IT IS USED FOR
WHAT TEMYBRIC ELLIPTA IS
Temybric 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 TEMYBRIC ELLIPTA IS USED FOR
Temybric 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

Características técnicas

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions. See section
4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Temybric 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
Temybric 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
_Adults _
The recommended and maximum dose is one inhalation of Temybric Ellipta
92/55/22 micrograms once
daily, at the same time each day.
If a dose is missed the next dose should be inhaled at the usual time
the next day.
_Special pop