Foster Nexthaler 100 micrograms6 micrograms per dose inhalation powder

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE

Boleh didapati daripada:

Orient Europharma (M) Sdn Bhd

INN (Nama Antarabangsa):

BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE

Unit dalam pakej:

1units Units; 1 Units

Dikeluarkan oleh:

CHIESI FARMACEUTICI SPA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FOSTER
® NEXTHALER
® INHALATION POWDER
_Beclometasone dipropionate/Formoterol Fumarate Dihydrate 100/6
mcg/dose _
1
__________________________________________________________________________________________
WHAT IS IN THIS LEAFLET
1.
What Foster
®
NEXThaler
®
is used for
2.
How
Foster
®
NEXThaler
®
works
3.
Before
you
use
Foster
®
Nexthaler
®
4.
How
to
use
Foster
®
NEXThaler
®
5.
While you are using Foster
®
NEXThaler
®
6.
Side effects
7.
Storage
and
Disposal
of
Foster
®
NEXThaler
®
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT FOSTER
® NEXTHALER
®
IS
USED FOR AND HOW IT WORKS
Foster
®
NEXThaler
®
is
a
powder
inhaled
through
your
mouth and delivered deeply into
your
lungs,
containing
beclomethasone diproprionate, a
glucocorticoid
with
anti-
inflammatory
action
which
reduces swelling and irritation in
the walls of the small air passage
in
the
lungs,
and
formoterol
fumarate,
a
selective
β
2
-
adrenergic agonist that produces
relaxation of bronchial smooth
muscle in patients with reversible
airway
obstruction.
The
combination
of
these
active
substances make breathing easier
by
providing
relief
from
symptoms such as shortness of
breath, wheezing and cough in
patients
with
asthma
and
also
help
to
prevent
asthma
from
worsening.
Foster
®
NEXThaler
®
is
indicated in the regular treatment
of patients with:
_ _
-
Asthma
not
adequately
controlled
with
inhaled
corticosteroids
and
“as
needed”
rapid-actingβ
2
-
agonists or
-
Asthma
already
controlled
on
both
inhaled
corticosteroid
and
long
acting β
2
-agonists.
-
Symptomatic
treatment
of
patients with severe Chronic
Obstructive
Pulmonary
Disease
(COPD)
(FEV
1
<
50% predicted normal) and a
history
of
repeated
exacerbations,
who
have
significant
symptoms
despite regular therapy with
long-acting bronchodilators
BEFORE
YOU
USE
FOSTER
®
NEXTHALER
®
_ _
_When you must not use it:_
-
If you are allergic or think
you are allergic to one or
more
of
the
activ

Ciri produk

PACKAGE INSERT
1.
NAME OF THE MEDICINAL PRODUCT
Foster
®
NEXThaler
®
100 micrograms/6 micrograms per inhalation inhalation powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of 10 mg inhalation powder contains:
100 micrograms of beclometasone dipropionate anhydrous and 6
micrograms of formoterol fumarate
dihydrate.
This is equivalent to a delivered dose (the dose leaving the
mouthpiece
)
of 81.9 micrograms of
beclometasone dipropionate anhydrous and 5.0 micrograms of formoterol
fumarate dihydrate.
Excipients with known effect:
Each inhalation contains 9.9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder.
The multidose inhaler contains a white or almost white powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASTHMA
Foster
®
NEXThaler
®
is indicated in the regular treatment of asthma where use of a
combination product
(inhaled corticosteroid and long-acting beta
2
-agonist) is appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled short-acting
beta
2
-agonist or
-
patients already adequately controlled on both inhaled corticosteroids
and long-acting beta
2
-agonists.
Foster
®
NEXThaler
®
is indicated for adult patients.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Symptomatic treatment of patients with severe COPD (FEV
1
<50% predicted normal) and a history of
repeated exacerbations, who have significant symptoms despite regular
therapy with long-acting
bronchodilators.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Foster
®
NEXThaler
®
is for inhalation use.
A
STHMA
Foster
®
NEXThaler
®
is not intended for the initial management of asthma.
The dosage of Foster
®
NEXThaler
®
is individual and should be adjusted to the severity of the disease.
This should be considered
not only when treatment with combination products is initiated but
also when the dose is adjusted. If an
individual patient should require a combination of doses other than
those available in the combina