Relvar Ellipta 10025 micrograms inhalation powder pre-dispensed

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

FLUTICASONE FUROATE; Vilanterol trifenatate

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

FLUTICASONE FUROATE; Vilanterol trifenatate

Unit dalam pakej:

30units Units; 30 ACTUATIONS

Dikeluarkan oleh:

GLAXOSMITHKLINE LLC

Risalah maklumat

_Consumer_
_ _
_Medication_
_ _
_Information_
_ _
_Leaflet_
_ _
_(RiMUP)_
_1 _
_ _
RELVAR ELLIPTA INHALATION
POWDER, PRE-DISPENSED
Fluticasone furoate/vilanterol (100/25 micrograms and 200/25
micrograms)
WHAT IS IN THIS LEAFLET
1.
What Relvar Ellipta is
used
for
2.
How Relvar Ellipta works
3.
Before you use Relvar
Ellipta
4.
How to use Relvar Ellipta
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal
of
Relvar Ellipta
8.
Product Description
9.
Manufacturer and
Product
Registration
Holder
10.
Date of Revision
11.
Serial Number
WHAT RELVAR ELLIPTA IS USED
FOR
The 100/25 micrograms
strength
is used for the
regular treatment
of chronic
obstructive
pulmonary
disease (COPD) in
adults, and
asthma in adults and
adolescents.
The 200/25 micrograms
strength
is used to treat
asthma in adults
and
adolescents . The 200/25
micrograms strength is not
for patients with COPD.
Relvar 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-acting inhaler
(such as
salbutamol).
HOW RELVAR ELLIPTA WORKS
Relvar Ellipta contains two
active substances: fluticasone
furoate and vilanterol. Two
different strengths of Relvar
Ellipta are available:
fluticasone
furoate 100
micrograms/vilanterol 25
micrograms and fluticasone
furoate 200
micrograms/vilanterol 25
micrograms.
Fluticasone furoate belongs
to a
group of medicines called
corticosteroids, often simply
called steroids.
Corticosteroids
reduce
inflammation. They
reduce
the swelling and irritation
in
the small air passages in the
lungs and so gradually ease
breathing problems.
Corticosteroids also help to
prevent attacks of asthma and
aggravation of COPD.
Vilanterol belongs to a group
of
medicines called long
acting
bronchodilators. It
relaxes the
muscles of the
small air passages
in the
lungs. This helps to open
the
airways and makes it easier
for air to get in and out of the
lungs. Wh

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1.
NAME OF THE MEDICINAL PRODUCT
Relvar Ellipta 100/25 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).
Fluticasone furoate/vilanterol has been formulated in two strengths
and one pack size, delivering 30
inhalations per Ellipta inhaler.
Excipients with known effect:
Each delivered dose contains approximately 25 mg of lactose (as
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 with a pale blue mouthpiece cover
and a dose counter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Asthma
Relvar 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.
Relvar Ellipta is indicated for the regular treatment of asthma in
adults aged 18 years and older where
use of a combination medicinal product (long-acting beta2-agonist and
inhaled corticosteroid) is
appropriate:
•
patients already adequately controlled on both inhaled corticosteroid
and long-acting beta
2
-
agonist.
COPD (Chronic Obstructive Pulmonary Disease)
Relvar 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 not adequately controlled with inhaled corticosteroids a