Kraj: Szwecja
Język: szwedzki
Źródło: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat; salmeterolxinafoat
Devatis GmbH
R03AK06
fluticasone propionate; salmeterol
25 mikrogram/250 mikrogram/dos
Inhalationsspray, suspension
flutikasonpropionat 250 mikrog Aktiv substans; salmeterolxinafoat 36,3 mg Aktiv substans
Receptbelagt
Förpacknings: Spraybehållare, 120 doser; Spraybehållare, 10 x 120 doser (sjukhusförpackning); Spraybehållare, 3 x 120 doser; Spraybehållare, 2 x 120 doser
Godkänd
2019-01-25
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Salmeterol/Flutikason Devatis 25 microgram/250 microgram/actuation, pressurised inhalation, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose (ex valve) contains: 36.3 microgram salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 250 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex actuator) of 21 micrograms of salmeterol and 220 micrograms of fluticasone propionate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, suspension (pressurised inhalation). White to off-white suspension in a metal container. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS {invented name} 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 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Route of administration: Inhalation use. Patients should be made aware that {invented name} must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of {invented name} they are receiving remains optimal and is only changed on medical advice. THE DOSE SHOULD BE TITRATED TO THE LOWEST DOSE AT WHICH EFFECTIVE CONTROL OF SYMPTOMS IS MAINTAINED. WHERE THE CONTROL OF SYMPTOMS IS MAINTAINED WITH {INVENTED NAME} 25/250 MICROGRAM/ACTUATION GIVEN TWICE DAILY THEN THE NEXT STEP COULD INCLUDE A SWAP TO A DIFFERENT INHALED SALMETEROL FLUTICASONE PRODUCT AVAILABLE IN LOWER STRENGTH (25/125 MICROGRAM OR 25/50 MICROGRAM). As an alternative, patients requiring a long-acting β 2 -agonist could be titrated to {invented name} given once daily if, in the opinion of the prescriber, Przeczytaj cały dokument