FOSTER 1006

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BECLOMETASONE DIPROPIONATE ANHYDROUS; FORMOTEROL FUMARATE DIHYDRATE

متاح من:

KAMADA LTD, ISRAEL

ATC رمز:

R03AK08

الشكل الصيدلاني:

PRESSURISED SOLUTION

تركيب:

FORMOTEROL FUMARATE DIHYDRATE 6 MCG/DOSE; BECLOMETASONE DIPROPIONATE ANHYDROUS 100 MCG/DOSE

طريقة التعاطي:

INHALATION

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CHIESI FARMACEUTICI S.P.A, ITALY

المجموعة العلاجية:

BECLOMETASONE

المجال العلاجي:

FORMOTEROL AND BECLOMETASONE

الخصائص العلاجية:

Foster is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting beta2-agonist or- patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.COPD :Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

تاريخ الترخيص:

2018-08-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
The medicine is dispensed with a doctor’s prescription only
FOSTER
®
100/6
PRESSURISED SOLUTION FOR INHALATION
The active ingredients and their quantities:
Each actuation releases:
Beclometasone dipropionate 100 mcg and Formoterol fumarate
dihydrate 6 mcg.
Inactive ingredients: see section 6 in the leaflet.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed to treat your ailment. Do not
pass it on to others. It may harm them even if it seems to you that
their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Treatment of asthma
Foster 100/6 is intended to treat 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 by combined treatment
with inhaled corticosteroids and long acting beta-2 agonist.
Treatment of Chronic Obstructive Pulmonary Disease – COPD
Foster 100/6 is intended for treatment of severe COPD symptoms in
patients with a history of recurrent episodes, who suffer significant
symptoms despite treatment with long-acting bronchodilators.
THERAPEUTIC GROUP:
Formoterol - beta agonist, bronchodilator.
Beclometasone - corticosteroid.
The two active substances in Foster 100/6 are beclometasone
dipropionate and formoterol fumarate dihydrate.
Beclometasone dipropionate belongs to a group called
corticosteroids )also referred to as steroids(, which have an anti-
inflammatory action, and reduce swelling and irritation in the lungs.
Formoterol fumarate dihydrate belongs to a group called long-acting
bronchodilators, which relax the muscles in airways and by doing
this, widen the airways, making it easie

خصائص المنتج

FOSTER
®
100/6
1.
NAME OF THE MEDICINAL PRODUCT
Foster 100/6
2.
QUALITATIVE AND QUANTITATIVE 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 formoterol fumarate dihydrate.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised solution for inhalation.
4.
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Asthma
Foster 100/6 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 adequately 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
P
OSOLOGY AND METHOD OF ADMINISTRATION
Foster 100/6 is for inhalation use.
POSOLOGY
A
STHMA
Foster
100/6
is not intended for the initial management of asthma. The dosage of
the components of
Foster 100/6 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 combination
inhaler, appropriate doses of beta
2
-agonists and/or corticosteroids by individual inhalers should be
prescribed.
Beclometasone dipropionate in Foster 100/6 is characterised by an
extrafine particle size distribution
which results in a more potent effect than formulations of
beclometasone dipropionate with a non-
extrafine particle size distribution (100