Država: Švedska
Jezik: švedščina
Source: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat; salmeterolxinafoat
Sandoz A/S
R03AK06
fluticasone propionate; salmeterol
50 mikrogram/250 mikrogram/dos
Inhalationspulver, avdelad dos
laktosmonohydrat Hjälpämne; salmeterolxinafoat 73 mikrog Aktiv substans; flutikasonpropionat 250 mikrog Aktiv substans
Apotek
Receptbelagt
Salmeterol och flutikason
Förpacknings: Inhalator, 1 x 60 doser; Inhalator, 2 x 60 doser; Inhalator, 3 x 60 doser; Inhalator, 4 x 60 doser; Inhalator, 5 x 60 doser; Inhalator, 6 x 60 doser; Inhalator, 10 x 60 doser
Avregistrerad
2015-05-21
PACKAGE LEAFLET: INFORMATION FOR THE USER Salmeterol/Fluticasone Sandoz, 50 microgram/250 microgram/dose, inhalation powder, predispensed SALMETEROL/FLUTICASONE PROPIONATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Salmeterol/Fluticasone Sandoz is and what it is used for 2. What you need to know before you use Salmeterol/Fluticasone Sandoz 3. How to use Salmeterol/Fluticasone Sandoz 4. Possible side effects 5. How to store Salmeterol/Fluticasone Sandoz 6. Contents of the pack and other information 1. WHAT SALMETEROL/FLUTICASONE SANDOZ IS AND WHAT IT IS USED FOR Salmeterol/Fluticasone Sandoz is used to treat: asthma This medicine contains two active substances. Salmeterol: a long-acting substance that widens the airways Fluticasone: a corticosteroid which reduces swelling and inflammation in the lungs 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SALMETEROL/FLUTICASONE SANDOZ DO NOT USE SALMETEROL/FLUTICASONE SANDOZ if you are ALLERGIC to salmeterol, fluticasone or to the other ingredient of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Salmeterol/Fluticasone Sandoz if you have: heart disease, including an irregular or fast heartbeat overactive thyroid gland high blood pressure diabetes mellitus low potassium in your blood tuberculosis now or in the past, or other lung infections Contact your doctor if you experience blurred vision or other visual disturbances. Salmeterol/Fluticasone Sando Preberite celoten dokument
Produktinformationen för Salmeterol/Fluticasone Sandoz 50 mikrogram/250 mikrogram/dos inhalationspulver, avdelad dos, MTnr 50816, gäller vid det tillfälle då läkemedlet godkändes. Informationen kommer inte att uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma anledning finns inte någon svensk produktinformation. Den engelska produktinformationen kommer dock att uppdateras för de produkter där Sverige är referensland. Om läkemedelsnamnet i följande produktinformation inte stämmer med namnet på dokumentet, beror det på att läkemedlet i Sverige är godkänt under ett annat namn. 1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Salmeterol/Fluticasone Sandoz, 50 microgram/250 microgram/dose, inhalation powder, predispensed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose of {Salmeterol/Fluticasone Sandoz} provides: For 50 microgram/250 microgram/dose, inhalation powder, predispensed: 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate. Corresponding with a delivered dose of: 45 micrograms of Salmeterol (as salmeterol xinafoate) and 233 micrograms of fluticasone propionate Excipient with known effect: lactose monohydrate: 12.20 mg per metered dose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed. White, homogenous powder. The pre-dispensed powder, contained in blister, is delivered by a purple plastic dry-powder inhalation device. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ASTHMA_ {Salmeterol/Fluticasone Sandoz} is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonist or patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2- agonist. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Preberite celoten dokument