Country: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
FLUTICASONPROPIONAAT 250 µg/dosis ; SALMETEROLXINAFOAAT 36,3 µg/dosis SAMENSTELLING overeenkomend met ; SALMETEROL 25 µg/dosis
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
R03AK06
FLUTICASONPROPIONAAT 250 µg/dosis ; SALMETEROLXINAFOAAT 36,3 µg/dosis SAMENSTELLING overeenkomend met ; SALMETEROL 25 µg/dosis
Aërosol, suspensie
NORFLURAAN,
Inhalatie
Salmeterol and fluticasone
Hulpstoffen: NORFLURAAN;
1900-01-01
V3 PACKAGE LEAFLET: INFORMATION FOR THE USER SALMETEROL/FLUTICASONPROPIONAAT SANDOZ 25/125 MICROGRAM, AEROSOL, SUSPENSIE SALMETEROL/FLUTICASONPROPIONAAT SANDOZ 25/250 MICROGRAM, AEROSOL, SUSPENSIE 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/Fluticasonpropionaat Sandoz is and what it is used for 2. What you need to know before you use Salmeterol/Fluticasonpropionaat Sandoz 3. How to use Salmeterol/Fluticasonpropionaat Sandoz 4. Possible side effects 5. How to store Salmeterol/Fluticasonpropionaat Sandoz 6. Contents of the pack and other information 1. WHAT SALMETEROL/FLUTICASONPROPIONAAT SANDOZ IS AND WHAT IT IS USED FOR Salmeterol/Fluticasonpropionaat Sandoz 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. Salmeterol/Fluticasonpropionaat Sandoz is not recommended for use by children. The doctor has prescribed this medicine to help prevent breathing problems such as asthma. You must use Salmeterol/Fluticasonpropionaat Sandoz every day as directed by your doctor. This will make sure that it works properly in controlling your asthma. Salmeterol/Fluticasonpropionaat Sandoz helps to stop breathlessness and wheeziness coming on. Howev Baca dokumen lengkap
SANDOZ Business use only Page 1 of 22 1.3.1 spc-label-pl - common-spc - 9,346 (NL/H/3707/001-002_Change ID 167714, PAR Art. 46) 20181105 SALMETEROL XINAFOATE+FLUTICASONE PROPIONATE 25 MCG + 125 MCG / 1 DOS 25 MCG + 250 MCG / 1 DOS PRESSURIZED INHALATION, SUSPENSION 722-2724.00 722-2725.00 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Salmeterol/Fluticasonpropionaat Sandoz 25/125 microgram, aerosol, suspensie Salmeterol/Fluticasonpropionaat Sandoz 25/250 microgram, aerosol, suspensie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION <{[NATIONALLY COMPLETED NAME] 25 MICROGRAMS/125 MICROGRAMS PER DOSE - PRESSURISED INHALATION, SUSPENSION}>_ _ Each metered dose (ex valve) contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 125 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex actuator) of 21 micrograms of salmeterol and 110 micrograms of fluticasone propionate. <{[NATIONALLY COMPLETED NAME] 25 MICROGRAMS/250 MICROGRAMS PER DOSE - PRESSURISED INHALATION, SUSPENSION}>_ _ Each metered dose (ex valve) contains 25 micrograms of salmeterol (as salmeterol xinafoate) 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. The container contains a white homogeneous suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed 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 SANDOZ Business use only Page 2 of 22 1.3.1 spc-label-pl - common-spc - 9,346 (NL/H/3707/001-002_Change ID 167714, PAR Art. 46) 20181105 SALMETEROL XINAFOATE+FLUTICASONE PROPIONATE 25 MCG + 125 MCG / 1 DOS 25 MCG + 250 MCG / Baca dokumen lengkap