País: Suecia
Idioma: sueco
Fuente: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat; salmeterolxinafoat
Cross Pharma AB
R03AK06
fluticasone propionate; salmeterol
50 mikrogram/250 mikrogram/dos
Inhalationspulver, avdelad dos
salmeterolxinafoat 72,5 mikrog Aktiv substans; laktosmonohydrat Hjälpämne; flutikasonpropionat 250 mikrog Aktiv substans
Apotek
Receptbelagt
Salmeterol och flutikason
Avregistrerad
2006-06-27
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER Seretide Diskus mite 50 microgram/100 microgram/ dose inhalation powder, pre-dispensed Seretide Diskus 50 microgram/250 microgram/ dose inhalation powder, pre-dispensed Seretide Diskus forte 50 microgram/500 microgram/ dose inhalation powder, pre-dispensed [To be completed nationally] salmeterol/fluticasone propionate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Seretide is and what it is used for 2. What you need to know before you use Seretide 3. How to use Seretide 4. Possible side effects 5. How to store Seretide 6. Contents of the pack and other information 1. WHAT SERETIDE IS AND WHAT IT IS USED FOR Seretide contains two medicines, salmeterol and fluticasone propionate: • Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to get in and out. The effects last for at least 12 hours. • Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs. The doctor has prescribed this medicine to help prevent breathing problems such as: • Asthma • Chronic Obstructive Pulmonary Disease (COPD). Seretide Diskus, at a dose of 50/500 micrograms, reduces the number of flare ups of COPD symptoms. You must use Seretide every day as directed by your doctor. This will make sure that it works properly in controlling your asthma or COPD. SERETIDE HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON. HOWEVER SERETIDE SHOULD NO Leer el documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Seretide Diskus mite 50 microgram/100 microgram/ dose inhalation powder, pre-dispensed. Seretide Diskus 50 microgram/250 microgram/ dose inhalation powder, pre-dispensed. Seretide Diskus forte 50 microgram/500 microgram/ dose inhalation powder, pre-dispensed. [To be completed nationally] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol xinafoate) and 92, 231 or 460 micrograms of fluticasone propionate. This corresponds to a pre-dispensed dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 100, 250 or 500 micrograms fluticasone propionate. Excipients with known effect: Each delivered dose contains up to 12.5 mg 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 28 or 60 regularly placed blisters. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ASTHMA_ Seretide is indicated in the regular treatment of asthma where use of a combination product _ _ (long- acting 2 agonist _ _ and inhaled corticosteroid) is _ _ appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting 2 agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting 2 agonist. Note: Seretide 50 microgram /100 microgram strength is not appropriate in adults and children with severe asthma. _CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_ 2 Seretide is indicated for the symptomatic treatment of patients with COPD, with a FEV 1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ Route of administration: Inhalation use. Patients should be made aware that Leer el documento completo