País: Israel
Idioma: anglès
Font: Ministry of Health
BECLOMETASONE DIPROPIONATE ANHYDROUS; FORMOTEROL FUMARATE DIHYDRATE
KAMADA LTD, ISRAEL
R03AK08
PRESSURISED SOLUTION
FORMOTEROL FUMARATE DIHYDRATE 6 MCG/ACTUATION; BECLOMETASONE DIPROPIONATE ANHYDROUS 200 MCG/ACTUATION
INHALATION
Required
CHIESI FARMACEUTICI S.P.A, ITALY
FORMOTEROL AND BECLOMETASONE
Foster 200/6 is indicated in the regular treatment of asthma in adults 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.
2020-05-27
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only Foster ® 200/6 Pressurised solution for inhalation The active ingredients and their quantities: Each actuation releases: Beclometasone dipropionate 200 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. The medicine is not intended for use in children and adolescents below the age of 18. 1. WHAT IS THE MEDICINE INTENDED FOR? Foster 200/6 is intended to treat asthma in adults, 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. Therapeutic group: Foster 200/6 is a pressurised inhalation solution containing two active substances which are inhaled through your mouth and delivered directly into your lungs. The two active substances in Foster 200/6 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 beta agonists, which are long-acting bronchodilators that relax the muscles in airways and by doing this, making it easier to breathe. These two active substances make breathing easier. They also help to prev Llegiu el document complet
FOSTER ® 200/6 1. NAME OF THE MEDICINAL PRODUCT Foster 200/6 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose (ex-valve) contains: 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Pressurised solution for inhalation. The canisters are fitted into a plastic actuator incorporating a mouthpiece and fitted with a dust cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Foster 200/6 is indicated in the regular treatment of asthma in adults 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Foster 200/6 is not intended for the initial management of asthma. The dosage of the components of Foster 200/6 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 200/6 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 micrograms of beclometasone dipropionate extrafine in Foster are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulatio Llegiu el document complet