Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
salmeterol, fluticasone propionate
Teva B.V.
R03AK06
salmeterol xinafoate, fluticasone propionate
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive; Asthma
Airexar Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1
Revision: 2
Withdrawn
2016-08-18
30 B. PACKAGE LEAFLET 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AIREXAR SPIROMAX 50 MICROGRAMS/500 MICROGRAMS INHALATION POWDER 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, pharmacist or nurse. - 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 pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Airexar Spiromax is and what it is used for 2. What you need to know before you use Airexar Spiromax 3. How to use Airexar Spiromax 4. Possible side effects 5. How to store Airexar Spiromax 6. Contents of the pack and other information 1. WHAT AIREXAR SPIROMAX IS AND WHAT IT IS USED FOR Airexar Spiromax 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. Your doctor has prescribed this medicine for the treatment of either Severe asthma, to help prevent attacks of breathlessness and wheeziness, or Chronic obstructive pulmonary disease (COPD), to reduce the number of flare ups of symptoms. You must use Airexar Spiromax every day as directed by your doctor. This will make sure that it works properly in controlling your asthma or COPD. AIREXAR SPIROMAX HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON. HOWEVER, AIREXAR SPIROMAX SHOULD NOT BE USED TO RELIEVE AN ATTACK OF BREATHLESSNESS OR WHEEZING. IF THIS HAPPENS YOU NEED TO USE A FAST-ACTING ‘RELIEVER’ (‘RE Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Airexar Spiromax 50 micrograms/500 micrograms inhalation powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate. Each delivered dose (the dose from the mouthpiece) contains 45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate. Excipient(s) with known effect: Each dose contains approximately 10 milligrams of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder. White powder. White inhaler with a semi-transparent yellow mouthpiece cover. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Airexar Spiromax is indicated for use in adults aged 18 years and older only._ _ Asthma Airexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product_ _(inhaled corticosteroid and long-acting β 2 agonist) is_ _appropriate: - patients not adequately controlled on a lower strength corticosteroid combination product or - patients already controlled on a high dose inhaled corticosteroid and long-acting β 2 agonist. Chronic Obstructive Pulmonary Disease (COPD) Airexar Spiromax 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 Airexar Spiromax is indicated in adults 18 years of age and older only. Airexar Spiromax is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age. _ _ 3 Posology Route of administration: Inhalation use Patients should be made aware that Airexar Spiromax must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the Izlasiet visu dokumentu