Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
SALBUTAMOL SULFATE
Noridem Enterprises Limited
R03AC02
SALBUTAMOL SULFATE
1.25/2.5 milligram(s)/millilitre
Nebuliser solution
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 Prečítajte si celý dokument
Health Products Regulatory Authority 23 June 2023 CRN00DHW7 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Brodilaten 1.25 mg/2.5 ml Nebuliser solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 2.5 mL of nebuliser solution contain 1.25 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 Symptomatic treatmentof acute severe asthma in children and infants. NOTE: Acute severe asthma requires hospital treatment in the intensive care unit. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Paediatric Population(under 12 years):_ This low-dose presentation is not suitable for treating adults, but is suitable for children and infants. _Infants: _ For infants and toddlers under 18 months: 50 to 150 microg of salbutamol / kg (i.e. 0.1 to 0.3 mL/kg of Brodilaten 1.25 mg in nebulised form) without generally exceeding 2.5 mg of salbutamol (i.e. two single doses of Brodilaten 1.25 mg or one single dose of Brodilaten 2.5 mg in nebulised form). For toddlers over 18 months up to 2 years old: 50 to 150 microg of salbutamol / kg (i.e. 0.1 to 0.3 mL/kg of Brodilaten 1.25 mg in nebulized form) without generally exceeding 5 mg (i.e. four single doses of Brodilaten 1.25 mg or one single dose of Brodilaten5 mg in nebulised form). _Children:_ For children aged 2 – 4 years: 50 to 150 microg of salbutamol / kg (i.e. 0.1 to 0.3 mL/kg of Brodilaten 1.25 mg in nebulized form) without generally exceeding 5 mg (i.e. four single doses of Brodilaten 1.25 mg or one single dose of Brodilaten 5 mg in nebulised form). For children aged 4 – 11 years: 2.5 mg to 5 mg salbutamol up to four times a day. The duration of action of the bronchiodilatory effect of inhaled salbutamol is between four and six hours. Under medical supervision, the nebulisation may be repeated every 20 to 30 minutes depending on the clinical result and tolerance of the treatment, witho Prečítajte si celý dokument