Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
fluticasone furoate, vilanterol
GlaxoSmithKline (Ireland) Limited
R03AK10
fluticasone furoate, vilanterol
Adrenergics and other drugs for obstructive airway diseases
Pulmonary Disease, Chronic Obstructive
Asthma indication:Relvar Ellipta is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting beta2-agonists.patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist.COPD indication:Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1
Revision: 25
Authorised
2013-11-13
66 B. PACKAGE LEAFLET 67 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RELVAR ELLIPTA 92 MICROGRAMS/22 MICROGRAMS INHALATION POWDER, PRE-DISPENSED RELVAR ELLIPTA 184 MICROGRAMS/22 MICROGRAMS INHALATION POWDER, PRE-DISPENSED fluticasone furoate/vilanterol 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 Relvar Ellipta is and what it is used for 2. What you need to know before you use Relvar Ellipta 3. How to use Relvar Ellipta 4. Possible side effects 5. How to store Relvar Ellipta 6. Contents of the pack and other information Step-by-step instructions for use 1. WHAT RELVAR ELLIPTA IS AND WHAT IT IS USED FOR Relvar Ellipta contains two active substances: fluticasone furoate and vilanterol. Two different strengths of Relvar Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms. The 92/22 micrograms strength is used for the regular treatment of chronic obstructive pulmonary disease ( COPD ) in adults, and ASTHMA in adults and adolescents 12 years and over. The 184/22 micrograms strength is used to treat ASTHMA in adults and adolescents aged 12 years and older. The 184/22 micrograms strength is not approved for the treatment of COPD. RELVAR ELLIPTA SHOULD BE USED EVERY DAY AND NOT ONLY WHEN YOU HAVE BREATHING PROBLEMS OR OTHER SYMPTOMS OF COPD AND ASTHMA. IT SHOULD NOT BE USED TO RELIEVE A SUDDEN ATTACK OF BREATHLESSNESS OR WHEEZING . If you get this sort of attack you must use a quick-acting inha Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate). This corresponds to a pre- dispensed dose of 100 micrograms of fluticasone furoate and 25 micrograms vilanterol (as trifenatate). Excipient with known effect Each delivered dose contains approximately 25 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed White powder in a light grey inhaler (Ellipta) with a yellow mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Asthma Relvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal 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 -agonists. • patients already adequately controlled on both inhaled corticosteroid and long-acting beta 2 -agonist. COPD (Chronic Obstructive Pulmonary Disease) Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV 1 <70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Asthma _ Patients with asthma should be given the strength of Relvar Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease. Prescribers should be aware that in patients with asthma, fluticasone furoate (FF) 100 micrograms once daily is approximately equivalent to fluticasone propionate (FP) 250 micrograms twice daily, while FF 200 micrograms once daily is approximately Lue koko asiakirja