Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
FORMOTEROL FUMARATE DIHYDRATE
NOVARTIS ISRAEL LTD
R03AC13
POWDER FOR INHALATION
FORMOTEROL FUMARATE DIHYDRATE 12 MCG
INHALATION
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
FORMOTEROL
FORMOTEROL
Foradil is indicated in asthma ( including nocturnal asthma and exercise-induced symptoms) in those treated with inhaled corticosteroids who also require a long-acting beta agonist in accordance with current treatment guidelines.Prophylaxis and treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.
2021-07-31
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FOR API APR21 V8 Ref: UK SmPC Dec2019 Business Use Only SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Foradil ® capsules for inhalation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 12 micrograms formoterol fumarate dihydrate. Excipient(s) with known effect: Each capsule contains 25 mg lactose (as the monohydrate). For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Powder For Inhalation, capsules Clear capsules containing a white powder, with "GC” printed on cap and "FXF" on body or "FXF" on cap and "GC" on body in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Foradil is indicated in asthma (including nocturnal asthma and exercise-induced symptoms) in those treated with inhaled corticosteroids who also require a long-acting beta agonist in accordance with current treatment guidelines. Prophylaxis and treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For use in adults and in children 6 years of age and older _ _ _ADULTS _ Asthma Foradil should only be prescribed as an add-on to an inhaled corticosteroid. Regular maintenance therapy: 1 to 2 inhalation capsules (equivalent to 12 to 24 micrograms formoterol) twice daily. Foradil should only be prescribed as an add-on to an inhaled corticosteroid (ICS). If required, an additional 1 to 2 capsules per day may be used for the relief of ordinary symptoms provided the recommended daily maximum dose of 48 micrograms per day is not exceeded. However, if the need for additional doses is more than occasional (e.g. more FOR API APR21 V8 Ref: UK SmPC Dec2019 Business Use Only frequent than 2 days per week) medical advice should be sought and therapy reassessed, as this may indicate a worsening of the underlying condition. The recommended maximum maintenance dose is 48 micrograms per day. Foradil should not be used to relieve the acute symptoms of an ast Pročitajte cijeli dokument