FOSTER 1006 MCGDOSE PRESSURISED INHALATION SOLUTION

Land: Maleisië

Taal: Engels

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

Werkstoffen:

Beclometasone dipropionate; Formoterol Fumarate Dihydrate

Beschikbaar vanaf:

Orient Europharma (M) Sdn Bhd

INN (Algemene Internationale Benaming):

Beclometasone dipropionate; Formoterol Fumarate Dihydrate

Eenheden in pakket:

1Units Units

Geproduceerd door:

CHIESI FARMACEUTICI SPA

Bijsluiter

_Consumer Medication Information Leaflet (RiMUP) _
______________________________________________________________________________
1
FOSTER PRESSURISED INHALATION
SOLUTION
Beclometasone dipropionate / Formoterol Fumarate Dihydrate (100/6
mcg/dose)
________________________________________________________________________________________________________
WHAT IS IN THIS LEAFLET
1.
What Foster is used for
2.
How Foster works
3.
Before you use Foster
4.
How to use Foster
5.
While you are using Foster
6.
Side effects
7.
Storage and disposal of Foster
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT FOSTER IS USED FOR
Foster is indicated in the regular
treatment of:
Asthma
_ _
- asthma not adequately controlled
with inhaled corticosteroids and “as
needed” rapid-acting β
2
-agonists or
- asthma already controlled on both
inhaled corticosteroids and long-
acting β
2
-agonists.
COPD
-Foster can also be used to treat the
symptoms of severe chronic
obstructive pulmonary disease
(COPD) in adults. COPD is a long
term disease of the airways in the
lungs which is primarily caused by
cigarette smoking.
HOW FOSTER WORKS
Foster
is
a
pressurised
inhalation
solution
containing
beclometasone
diproprionate, a glucocorticoid with
anti-inflammatory
action
reducing
the
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 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
asthma
and
also
help
to
prevent
asthma worsening.
BEFORE YOU USE FOSTER
-
_When you must not use it:_
-If you are allergic or think you are
allergic to one or other of the active
ingredients of Foster, or if you are
allergic
to
other
medicines
or
inhalers used to treat asthma or to
any of the other ingredients of Foster,
contact your doctor for advice.
PR

Productkenmerken

Foster
Summary of Product Characteristics
Pag e 1 of 21
1. FOSTER 100/6 MCG/DOSE PRESSURISED INHALATION SOLUTION NAME OF THE MEDICINA L
PRODUCT
Foster 100/6 micrograms per actuation pressurised inhalation solution .
2. QUALITATIVE AND QUAN TITATIVE COMPOSITION
Each metered dose (ex -valve) contains:
100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate.
This is equivalent to a delivered dose (ex -actuator) of 84.6 micrograms of beclometasone
dipropionate and 5.0 micrograms of formoter ol fumarate dihydrate.
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Pressurised inhalation solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Asthma
Foster 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 rapid -acting
beta 2-agonist or
- patients already adequate ly controlled on both inhaled corticosteroids and long -acting beta 2-
agonists.
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 A DMINISTRATION
FOSTER is for inhalation use.