Pays: Israël
Langue: anglais
Source: Ministry of Health
BECLOMETASONE DIPROPIONATE ANHYDROUS; FORMOTEROL FUMARATE DIHYDRATE
KAMADA LTD, ISRAEL
R03AK08
PRESSURISED SOLUTION
FORMOTEROL FUMARATE DIHYDRATE 6 MCG/DOSE; BECLOMETASONE DIPROPIONATE ANHYDROUS 100 MCG/DOSE
INHALATION
Required
CHIESI FARMACEUTICI S.P.A, ITALY
BECLOMETASONE
FORMOTEROL AND BECLOMETASONE
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.
2018-08-31
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 Lire le document complet
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 Lire le document complet