Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
salmeterol xinafoate, fluticasone propionate
Teva B.V.
R03AK06
salmeterol, fluticasone propionate
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive; Asthma
Aerivio Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAerivio 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 product orpatients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Aerivio Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1
Revision: 2
Withdrawn
2016-08-18
30 B. PACKAGE LEAFLET Medicinal product no longer authorised 31 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AERIVIO 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 Aerivio Spiromax is and what it is used for 2. What you need to know before you use Aerivio Spiromax 3. How to use Aerivio Spiromax 4. Possible side effects 5. How to store Aerivio Spiromax 6. Contents of the pack and other information 1. WHAT AERIVIO SPIROMAX IS AND WHAT IT IS USED FOR Aerivio 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 Aerivio Spiromax every day as directed by your doctor. This will make sure that it works properly in controlling your asthma or COPD. AERIVIO SPIROMAX HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON. HOWEVER, AERIVIO SPIROMAX SHOULD NOT BE USED TO RELIEVE AN ATTACK OF BREATHLESSNESS OR WHEEZING. IF THIS HAPPENS YOU NEED TO Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Aerivio 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 Aerivio Spiromax is indicated for use in adults aged 18 years and older only._ _ Asthma Aerivio 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) Aerivio 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 Aerivio Spiromax is indicated in adults 18 years of age and older only. Aerivio Spiromax is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age. _ _ Medicinal product no longer authorised 3 Posology Route of administration: Inhalation use Patients should be made aware that Aerivio Spiromax must be used daily for optimum benefit, even when a Izlasiet visu dokumentu