Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE
LTT Pharma Limited
R03AK07
BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE
400/12 Mcg/Dose
Powder for Inhalation
inspiratory flow-driven
Each inhaler containing 60 doses
Product subject to prescription which may be renewed (B)
AstraZeneca AB, AstraZeneca GmbH, AstraZeneca UK Limited
Adrenergics and other drugs for obstructive airway diseases
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
It is indicated in adults and adolescents aged 12 to17 years for the regular treatment of asthma and for the symptomatic treatment of patients with severe COPD
Authorised
2015-08-07
THE MANUFACTURER IS: AstraZeneca AB, Sӧdertälje, Sweden AstraZeneca GmbH, Wedel, Germany AstraZeneca UK Limited, Cheshire, UK Symbicort and Turbohaler are registered trademarks of the AstraZeneca AB Leaflet revision date: 10/01/2017 PPA1562/165/002 Blind or partially sighted? Is this leaflet hard to see or read? Phone LTT Pharma Limited, Tel: +44(0)1527 505414 for help. THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA UNDER THE FOLLOWING NAMES: 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 Symbicort Turbohaler is and what it is used for 2. What you need to know before you use Symbicort Turbohaler 3. How to use Symbicort Turbohaler 4. Possible side effects 5. How to store Symbicort Turbohaler 6. Contents of the pack and other information 1. WHAT SYMBICORT TURBOHALER IS AND WHAT IT IS USED FOR Symbicort Turbohaler is an inhaler that is used to treat asthma in adults and adolescents aged 12 to 17 years. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. It 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 br Կարդացեք ամբողջական փաստաթուղթը
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Symbicort Turbohaler, 400 micrograms/12 micrograms/inhalation, inhalation powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 320 micrograms/inhalation and formoterol fumarate dihydrate 9 micrograms/inhalation. Each metered dose contains: budesonide 400 micrograms/inhalation and formoterol fumarate dihydrate 12 micrograms/inhalation. Excipient with known effect: Contains Lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder _Product imported from Slovakia_ White powder 4 CLINICAL PARTICULARS As per PA0970/028/003 5 PHARMACOLOGICAL PROPERTIES As per PA0970/028/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate (which contains milk proteins) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the inhaler and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30 ° C. Keep the container tightly closed, in order to protect from moisture. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 06/01/2017_ _CRN 2185964_ _page number: 1_ 6.5 NATURE AND CONTENTS OF CONTAINER Symbicort Turbohaler is an inspiratory flow-driven, multidose powder inhaler. The inhaler is white with a red turning grip. Each inhaler containing 60 doses. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements 7 PARALLEL PRODUCT AUTHORISATION HOLDER LTT Pharma Limited Unit 18 Oxleasow Road East Moons Moat Redditch Worcestershire B98 0RE United Kingdom 8 PARALLEL PRODUCT AUTHORISATION Կարդացեք ամբողջական փաստաթուղթը