Riik: Rootsi
keel: rootsi
Allikas: Läkemedelsverket (Medical Products Agency)
budesonid; formoterolfumaratdihydrat
AstraZeneca AB
R03AK07
budesonide; formoterol
160 mikrogram/4,5 mikrogram/inhalation
Inhalationsspray, suspension
budesonid 160 mikrog Aktiv substans; formoterolfumaratdihydrat 4,5 mikrog Aktiv substans
Receptbelagt
Förpacknings: Inhalator, 120 doser
Godkänd
2016-02-18
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER GARDETTE 160 MICROGRAMS /4.5 MICROGRAMS/ACTUATION PRESSURISED INHALATION, SUSPENSION Budesonide/Formoterol fumarate dihydrate 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 or pharmacist. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Gardette is and what it is used for 2. What you need to know before you use Gardette 3. How to use Gardette 4. Possible side effects 5. How to store Gardette 6. Contents of the pack and other information 1. WHAT GARDETTE IS AND WHAT IT IS USED FOR Gardette is an inhaler that is used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 and older. COPD is a long-term disease of the airways in the lungs, which is often caused by cigarette smoking. Gardette contains two different medicines: budesonide and formoterol fumarate dihydrate. Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in your lungs. Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta 2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This helps you to breathe more easily. Do not use this medicine as a “reliever” inhaler. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GARDETTE DO NOT USE GARDETTE: if you are allergic to budesonide, formoterol or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Lugege kogu dokumenti
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1 . NAME OF THE MEDICINAL PRODUCT Gardette, 160 micrograms/4.5 micrograms/actuation pressurised inhalation, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (ex-actuator) contains: budesonide 160 micrograms/actuation and formoterol fumarate dihydrate 4.5 micrograms/actuation. This is equivalent to a metered dose containing budesonide 200 micrograms/actuation and formoterol fumarate dihydrate 6 micrograms/actuation. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, suspension. White suspension in an aluminium canister fitted into a red actuator with a grey dust cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) Gardette is indicated in adults, aged 18 and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV 1 ) <70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy (see also section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Inhalation use. COPD _Recommended dose:_ _Adults:_ 2 actuations twice daily. GENERAL INFORMATION _Special patient groups:_ There are no special dosing requirements for elderly patients. There are no data available for use of Gardette in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis. _Paediatric Population:_ There is no relevant use of Gardette 160 micrograms /4.5 micrograms in children 11 years of age and under or in adolescents 12 to 17 years of age in the symptomatic treatment of COPD. INSTRUCTIONS FOR THE CORRECT USE OF GARDETTE On actuation of Gardette, a volume of the suspension is expelled from the canister at high velocity. When the patient inhales through the mouthpiece at the same time as actuating the inhaler, the substance will Lugege kogu dokumenti