국가: 이스라엘
언어: 영어
출처: Ministry of Health
UMECLIDINIUM AS BROMIDE
GLAXO SMITH KLINE (ISRAEL) LTD
R03BB07
POWDER FOR INHALATION
UMECLIDINIUM AS BROMIDE 55 MCG
INHALATION
Required
GLAXO OPERATIONS UK LIMITED ( TRADING AS GLAXO WELLCOME OPERATIONS)
UMECLIDINIUM BROMIDE
INCRUSE is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
2020-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed according to a physician’s prescription only INCRUSE ELLIPTA 55 MCG, INHALATION POWDER Each dose released from the Incruse Ellipta inhaler contains 55 micrograms of the active ingredient, Umeclidinium (equivalent to 65 micrograms of umeclidinium bromide). For the list of the inactive and allergenic ingredients, see section 2 - “Important information about some of the ingredients of the medicine” and section 6 - “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Incruse Ellipta contains the active substance umeclidinium. 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. Tightening of the muscles around the airways narrows the airways and restricts the flow of air, thereby adding to breathing difficulties. 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 difficulties and reduce the effects of COPD on your everyday life. INCRUSE ELLIPTA 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 reliever inhaler (such as salbutamol). If you do not have a quick-acting inhaler, contact your physician. THERAPEUTIC GROUP: anticholinergic. Incruse Ellipta belongs to a group of medicines called bronchodilators. 2. BEFORE USING THE MEDICINE DO NOT 전체 문서 읽기
Page 1 of 11 1 1. NAME OF THE MEDICINAL PRODUCT Incruse 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 the inhaler) 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 Incruse 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 of umeclidinium bromide once daily. Incruse Ellipta should be administered each day at the same time of the day to maintain bronchodilation. The maximum dose is one inhalation of umeclidinium bromide once daily. _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). Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. Incruse Ellipta has not been studied in patients with severe hepatic impairment and should be used with caution (see section 5.2). _Paediatric population _ There is no relevant use of Incruse Ellipta in the paediatric population (under 18 years of age) for the indication of COPD. _ _ Method of administration Page 2 of 11 2 For inhalation use only. The following instructions for the 30 dose inhaler (30 day supply) 전체 문서 읽기