Land: Armenien
Språk: engelska
Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fluticasone (fluticasone furoate), vilanterol
Glaxo Operations UK Ltd
R03AK10
fluticasone (fluticasone furoate), vilanterol
200mcg/dose+ 25mcg/dose
powder for inhalation
powder in strip (60/2x30/ dose) in plastic inhaler
Prescription
Registered
2016-02-26
Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre- dispensed Summary of Product Characteristics 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 f1uticasone furoate and 22 micrograms of vilanterol (as trifenatate).This corresponds to a pre-dispensed dose of 100 micrograms of f1uticasone furoate and 25 micrograms vilanterol (as trifenatate). Excipients with known effect: Each delivered dose contains approximately 25 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Inhalation powder, pre-dispensed (Inhalation powder). White powder in a light grey inhaler 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--aqonist and inhaled corticosteroid) is appropriate: • patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta--aqonlsts .. CO PO (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_ _Adults_ _and adolescents_ _aged_ 12 years _and over_ One inhalation of Relvar Ellipta_ 92/22_ micrograms once daily. Patients usually experience an improvement in lung function within 15 minutes of inhaling Relvar Ellipta. However, the patient should be informed that regular daily usage is necessary to maintain control of asthma symptoms and that use should be continued even when asymptomatic. If symptoms arise in the period between Läs hela dokumentet