מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
umeclidinium bromide
GlaxoSmithKline Trading Services Limited
R03BB07
umeclidinium
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
Rolufta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).,
Revision: 11
Authorised
2017-03-20
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROLUFTA ELLIPTA 55 MICROGRAMS INHALATION POWDER, PRE-DISPENSED umeclidinium 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 Rolufta Ellipta is and what it is used for 2. What you need to know before you use Rolufta Ellipta 3. How to use Rolufta Ellipta 4. Possible side effects 5. How to store Rolufta Ellipta 6. Contents of the pack and other information Step-by-step instructions for use 1. WHAT ROLUFTA ELLIPTA IS AND WHAT IT IS USED FOR WHAT ROLUFTA ELLIPTA IS Rolufta Ellipta contains the active substance umeclidinium (as bromide), which belongs to a group of medicines called bronchodilators. WHAT ROLUFTA ELLIPTA IS USED FOR This medicine is used to treat chronic obstructive pulmonary disease ( COPD ) in adults. COPD is a long-term condition in which the airways and air-sacs in the lungs gradually become blocked or damaged, leading to breathing difficulties that slowly get worse. Difficulties in breathing is added to by tightening of the muscles around the airways, which narrows the airways and so restricts the flow of air. This medicine blocks the tightening of these muscles, making it easier for air to get in and out of the lungs. When used regularly, it can help control your breathing di קרא את המסמך השלם
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 Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide). This corresponds to a pre- dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide. Excipient with known effect Each delivered dose contains approximately 12.5 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 grey inhaler (Ellipta) with a light green mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rolufta 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 dose is one inhalation once daily. It should be administered each day at the same time of the day to maintain bronchodilation. The maximum dose is one inhalation once daily. 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. Umeclidinium has not been studied in patients with severe hepatic impairment and should be used with c קרא את המסמך השלם