Država: Švedska
Jezik: švedščina
Source: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat; salmeterolxinafoat
1A Farma A/S
R03AK06
fluticasone propionate; salmeterol
50 mikrogram/250 mikrogram/dos
Inhalationspulver, avdelad dos
laktosmonohydrat Hjälpämne; flutikasonpropionat 0,25 mg Aktiv substans; salmeterolxinafoat 0,073 mg Aktiv substans
Receptbelagt
Förpacknings: Inhalator, 1 x 60 doser; Inhalator, 10 x 60 doser; Inhalator, 6 x 60 doser; Inhalator, 5 x 60 doser; Inhalator, 4 x 60 doser; Inhalator, 3 x 60 doser; Inhalator, 2 x 60 doser
Avregistrerad
2017-02-17
PACKAGE LEAFLET: INFORMATION FOR THE USER [Salmeterol/Fluticasone 1A Farma, 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 1A Farma] is and what it is used for 2. What you need to know before you use [Salmeterol/Fluticasone 1A Farma] 3. How to use [Salmeterol/Fluticasone 1A Farma] 4. Possible side effects 5. How to store [Salmeterol/Fluticasone 1A Farma] 6. Contents of the pack and other information 1. WHAT [SALMETEROL/FLUTICASONE 1A FARMA] IS AND WHAT IT IS USED FOR [Salmeterol/Fluticasone 1A Farma] 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 1A FARMA] DO NOT USE [SALMETEROL/FLUTICASONE 1A FARMA] 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 1A Farma] if you have: heart disease, including an irregular or fast heartbeat overactive thyroid gland high blood pressure diabetes mellitus ([Salmeterol/Fluticasone 1A Farma] may increase your blood sugar) low potassium in your blood tuberculosis (TB) now or in the past or other lung infections C Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT {Salmeterol/Fluticasone 1A Farma, 50 microgram/250 microgram/dose, inhalation powder, pre- dispensed} {Salmeterol/Fluticasone 1A Farma, 50 microgram/500 microgram/dose, inhalation powder, pre- dispensed} 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose of {Salmeterol/Fluticasone 1A Farma} provides: For 50 microgram/250 microgram/dose, inhalation powder, pre-dispensed: 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 Each metered dose of {Salmeterol/Fluticasone 1A Farma} provides: For 50 microgram/500 microgram/dose, inhalation powder, pre-dispensed: 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate. Corresponding with a delivered dose of: 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate Excipient with known effect Lactose monohydrate: 11.95 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 1A Farma} 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. _CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_ {Salmeterol/Fluticasone 1A Farma} is indicated for the symptomatic t Preberite celoten dokument