Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
BUDESONIDE FORMOTEROL FUMATRATE DIHYDRATE
AstraZeneca UK Limited
400/12 Mcg/Dose
Powder for Inhalation
2010-11-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Edoflo 400micrograms/12micrograms/Inhalation, Inhalation powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 320 micrograms/inhalation and formoterol fumarate dihydrate 9 micrograms/inhalation. Each metered dose contains: budesonide 400 micrograms / inhalation and formoterol fumarate dihydrate 12 micrograms / inhalation. Excipient: Lactose monohydrate 491 micrograms per dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder White powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA Edoflo is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long- acting 2 adrenoceptor agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short -acting 2 adrenoceptor agonists. or - patients already adequately controlled on both inhaled corticosteroids and long-acting 2 adrenoceptor 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 ADMINISTRATION Route of administration: For inhalation use ASTHMA Edoflo is not intended for the initial management of asthma. The dosage of the components of Edoflo 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 maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses o Preberite celoten dokument