País: Suecia
Idioma: sueco
Fuente: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat; salmeterolxinafoat
Neutec lnhaler lreland Limited
R03AK06
fluticasone propionate; salmeterol
50 mikrogram/100 mikrogram/dos
Inhalationspulver, avdelad dos
flutikasonpropionat 100 mikrog Aktiv substans; salmeterolxinafoat 73 mikrog Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagt
Förpacknings: Inhalator, 1 x 60 doser; Inhalator, 10 x 60 doser; Inhalator, 3 x 60 doser; Inhalator, 2 x 60 doser
Godkänd
2020-02-11
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Neuair Airmaster 50 microgram/100 microgram/ dose inhalation powder, pre-dispensed Neuair Airmaster 50 microgram/250 microgram/ dose inhalation powder, pre-dispensed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Neuair Airmaster 50 microgram /100 microgram Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone propionate. This corresponds to a pre-metered dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 100 micrograms fluticasone propionate. Neuair Airmaster 50 microgram /250 microgram Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone propionate. This corresponds to a pre-metered dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms fluticasone propionate. Excipient with known effect Each delivered dose contains approximately 13 milligrams of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed. Moulded plastic device containing a foil strip with 60 regularly placed blisters. Each blister contains pre-dispensed dose of white to off white inhalation powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Neuair Airmaster is indicated in adults and adolescents 12 years of age and older. _ASTHMA_ Neuair Airmaster is indicated in the regular treatment of asthma where use of a combination product (long- acting β 2 agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short- acting β 2 agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting β 2 agonist Note: Neuair Airmaster 50 microgram /100 microgram strength is not appropriate in adults and children with Leer el documento completo