국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
fluticasone furoate, umeclidinium bromide, vilanterol trifenatate
GlaxoSmithKline Trading Services Limited
R03AL08
fluticasone furoate, umeclidinium, vilanterol
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
Temybric Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
Revision: 4
Withdrawn
2019-06-12
32 B. PACKAGE LEAFLET Medicinal product no longer authorised 33 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TEMYBRIC ELLIPTA 92 MICROGRAMS/55 MICROGRAMS/22 MICROGRAMS INHALATION POWDER, PRE-DISPENSED fluticasone furoate/umeclidinium/vilanterol This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Temybric Ellipta is and what it is used for 2. What you need to know before you use Temybric Ellipta 3. How to use Temybric Ellipta 4. Possible side effects 5. How to store Temybric Ellipta 6. Contents of the pack and other information Step-by-step instructions 1. WHAT TEMYBRIC ELLIPTA IS AND WHAT IT IS USED FOR WHAT TEMYBRIC ELLIPTA IS Temybric Ellipta contains three active substances called fluticasone furoate, umeclidinium bromide and vilanterol. Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids. Umeclidinium bromide and vilanterol belong to a group of medicines called bronchodilators. WHAT TEMYBRIC ELLIPTA IS USED FOR Temybric Ellipta is used to treat chronic obstructive pulmonary disease _ _ ( COPD ) in adults. COPD is a long- term condition characterised by breathing difficulties that slowly get worse. In COPD the muscles around the airways tighten, making breathing difficult. This medicine widens these muscles 전체 문서 읽기
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92 micrograms/55 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 fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 22 micrograms vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 100 micrograms fluticasone furoate, 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium 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 (inhalation powder). White powder in a light grey inhaler (Ellipta) with a beige mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Temybric Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology _Adults _ The recommended and maximum dose is one inhalation of Temybric Ellipta 92/55/22 micrograms once daily, at the same time each day. If a dose is missed the next dose should be inhaled at the usual time the next day. _Special pop 전체 문서 읽기