国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Budesonide
Teva Pharma B.V.
R03BA; R03BA02
Budesonide
1 mg/2ml
Nebuliser suspension
Product subject to prescription which may be renewed (B)
Glucocorticoids; budesonide
Marketed
2014-03-07
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BUDESONIDE TEVA PHARMA 0.5 MG/2 ML NEBULISER SUSPENSION BUDESONIDE TEVA PHARMA 1 MG/2 ML NEBULISER SUSPENSION budesonide 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 Budesonide Teva Pharma Nebuliser Suspension is and what it is used for 2. What you need to know before you use Budesonide Teva Pharma Nebuliser Suspension 3. How to use Budesonide Teva Pharma Nebuliser Suspension 4. Possible side effects 5. How to store Budesonide Teva Pharma Nebuliser Suspension 6. Contents of the pack and other information 1. WHAT BUDESONIDE TEVA PHARMA NEBULISER SUSPENSION IS AND WHAT IT IS USED FOR Budesonide belongs to a group of steroids called glucocorticosteroids which can be used to reduce or prevent inflammatory reactions (swelling) in the lungs. This medicine can be used in adults, adolescents, children and infants aged 6 months and older. Your medicine is used for the treatment of asthma. It is used in patients where other types of inhaler, such as a pressurised inhaler or an inhaler containing a dry powder are unsatisfactory or inappropriate. Budesonide Nebuliser suspension can also be used to treat very serious pseudocroup (laryngitis subglottica) in infants and children who are in hospital. Budesonide Nebuliser suspension can also be given for the treatment of lung attacks in chronic obstructive pulmonary disease (COPD) as an alternative to systemic (oral and/or injection) anti-inflammatories, only after suitable training in the use of this nebulised medic 阅读完整的文件
Health Products Regulatory Authority 10 October 2022 CRN00D0ZX Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Budesonide Teva Pharma 1 mg/2 ml Nebuliser Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Budesonide Teva Pharma 1 mg/2 ml Nebuliser Suspension: Each ampoule of 2 ml suspension contains 1 mg budesonide. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser suspension. A white to off white suspension in a single dose ampoule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Budesonide Nebuliser Suspension is indicated in adults, adolescents, children and infants aged six months and older. _Asthma_ Budesonide Nebuliser Suspension is indicated for the use in persistent bronchial asthma, in patients where use of a pressurised inhaler or dry powder formulation is unsatisfactory or inappropriate. _Pseudocroup_ Very serious pseudocroup (laryngitis subglottica), in which hospitalisation is indicated. _Chronic obstructive pulmonary disease (COPD)_ Exacerbations of chronic obstructive pulmonary disease (COPD) as an alternative to systemic corticosteroids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _General_ Budesonide Nebuliser Suspension are nebulised using a suitable nebuliser (jet nebuliser with mouthpiece and face mask). The amount of budesonide that reaches the patient when administered via a nebuliser varies and depends on the following factors, among others: • nebulisation time • the volume used; • the properties of the nebuliser; • the ratio of inspiratory and expiratory volume of the patient and the dead space; • the use of face mask or mouthpiece. _ASTHMA_ The dose should be given twice daily. Administration once daily may be considered in cases of mild to moderate stable asthma. INITIAL DOSAGE The initial dose should be tailored to the severity of the disease and thereafter should be adjusted on an individual basis. The following doses are recommended but the minimum effective dose should always be sought. Children ag 阅读完整的文件