国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
SALBUTAMOL SULFATE
Noridem Enterprises Limited
R03AC; R03AC02
SALBUTAMOL SULFATE
5.0/2.5 milligram(s)/millilitre
Nebuliser solution
Selective beta-2-adrenoreceptor agonists; salbutamol
Not marketed
2019-09-13
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER Brodilaten 1.25 mg / 2.5 mL Nebuliser solution Brodilaten 2.5 mg / 2.5 mL Nebuliser solution Brodilaten 5.0 mg / 2.5 mL Nebuliser solution Salbutamol 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, nurse 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. THE NAME OF YOUR MEDICINE IS THE FOLLOWING: - Brodilaten 1.25 mg / 2.5 mL Nebuliser solution - Brodilaten 2.5 mg / 2.5 mL Nebuliser solution - Brodilaten 5.0 mg / 2.5 mL Nebuliser solution In the rest of this leaflet your medicine is called Brodilaten. WHAT IS IN THIS LEAFLET 1. What Brodilaten is and what it is used for 2. What you need to know before you use Brodilaten 3. How to use Brodilaten 4. Possible side effects 5. How to store Brodilaten 6. Contents of the pack and other information 1. WHAT BRODILATEN IS AND WHAT IT IS USED FOR Brodilaten contains a medicine called salbutamol. This belongs to a group of medicines called fast- acting bronchodilators. • Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get in and out. • They help to relieve chest tightness, wheezing and cough. BRODILATEN 1.25 MG/2.5 ML: This low dose is adapted for use in children and infants only to treat severe asthma attacks, where inhalation of high doses of salbutamol is required. Brodilaten is used to treat breathing problems in people with asthma and other chest illnesses. It is usually given to people who suffer quite badly from these conditions. Brodilaten is also given to treat severe attacks of asthma. Brodilaten is a liquid contain 完全なドキュメントを読む
Health Products Regulatory Authority 23 June 2023 CRN00DHW7 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brodilaten 5.0 mg/2.5 ml Nebuliser solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2.5 mL of nebuliser solution contain 5.00 mg salbutamol (as salbutamol sulfate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser solution. Clear and colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Brodilatenis indicated in adults, adolescents and children aged 4 to 11 years. Brodilaten 5.0 mg / 2.5 mL Nebuliser solution is not indicated for babies and children under 4 years of age, see section 4.2 Brodilatenis indicated for treatment of severe acute exacerbations of chronic obstructive pulmonary disease (COPD), and in the treatment of acute severe asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly):_ 2.5 mg to 5 mg salbutamol up to four times a day. Up to 40 mg per day can be given under strict medical supervision in hospital. _Paediatric Population_ Children aged 12 years and over: Dose as per adult population. Children aged 4-11 years: 2.5 mg to 5 mg up to four times a day. The clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered. Brodilaten is intended to be used undiluted. However, if prolonged delivery time (more than 10 minutes) is required, the solution may be diluted with sterile normal saline to a 1:1 dilution. Method of administration Brodilaten is for inhalation use only, to be breathed in through the mouth, under the direction of a physician, using a suitable nebuliser. The solution should not be injected or swallowed. For single use only. Use immediately after first opening the single-dose container. Any solution remaining in the nebuliser after nebulisation should be discarded. Brodilaten may be administered from a suitable nebuliser, e.g. PARI LC SPRINT nebuliser, after 完全なドキュメントを読む