Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
BUDESONIDE FORMOTEROL FUMATRATE DIHYDRATE
AstraZeneca UK Limited
100/6 Microgram
Powder for Inhalation
2011-01-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Budfor 100micrograms/6micrograms/Inhalation, Inhalation powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 80 micrograms/inhalation and formoterol fumarate dihydrate 4.5 micrograms/inhalation. Each metered dose contains: budesonide 100 micrograms/inhalation and formoterol fumarate dihydrate 6 micrograms/inhalation. Excipient: Lactose monohydrate 810 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 Budfor 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. NOTE: Budfor (100 micrograms/6 micrograms/inhalation) is not appropriate in patients with severe asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: For inhalation use Budfor is not intended for the initial management of asthma. The dosage of the components of Budfor 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 of 2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed. The dose should be titrated to the Les hele dokumentet