البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
umeclidinium bromide, vilanterol
GlaxoSmithKline (Ireland) Limited
R03AL03
umeclidinium bromide, vilanterol
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
Laventair Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Revision: 17
Authorised
2014-05-08
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER LAVENTAIR ELLIPTA 55 MICROGRAMS/22 MICROGRAMS INHALATION POWDER, PRE-DISPENSED 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 LAVENTAIR ELLIPTA is and what it is used for 2. What you need to know before you use LAVENTAIR ELLIPTA 3. How to use LAVENTAIR ELLIPTA 4. Possible side effects 5. How to store LAVENTAIR ELLIPTA 6. Contents of the pack and other information Step-by-step instructions 1. WHAT LAVENTAIR ELLIPTA IS AND WHAT IT IS USED FOR WHAT LAVENTAIR ELLIPTA IS LAVENTAIR ELLIPTA contains two active substances umeclidinium bromide and vilanterol. These belong to a group of medicines called bronchodilators. WHAT LAVENTAIR ELLIPTA IS USED FOR LAVENTAIR 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. This medicine blocks the tightening of these muscles in the lungs, making it easier for air to get in and out of the lungs. When used regularly, it can help to control your breathing difficulties and reduce the effects of COPD on your everyday life. LAVENTAIR ELLIPTA SHOULD NOT BE USED TO RELIEVE A اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 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 LAVENTAIR ELLIPTA 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 65 micrograms umeclidinium bromide equivalent to 55 micrograms of umeclidinium and 22 micrograms of vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 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 24 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 (ELLIPTA) with a red mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LAVENTAIR ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology The recommended and maximum dose is one inhalation once daily. LAVENTAIR ELLIPTA should be administered at the same time of the day each day to maintain bronchodilation. If a dose is missed the next dose should be inhaled at the usual time the next day. _Special populations _ _ _ _Elderly_ No dose adjustment is required in patients 65 years of age or older (see section 5.2). _Renal impairment _ No dose adjustment is required in patients with renal impairment (see section 5.2). 3 _Hepatic impairment _ No dose adjustment is required in patients with mild or moderate hepatic impairment. The use of LAVENT اقرأ الوثيقة كاملة