Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Salbutamol
GlaxoSmithKline (Ireland) Limited
R03AC; R03AC02
Salbutamol
2.5 mg/2.5 millilitre(s)
Nebuliser solution
Product subject to prescription which may be renewed (B)
Selective beta-2-adrenoreceptor agonists; salbutamol
Not marketed
1984-07-18
Reason for Update: Type IA removal of BC as BR site (Brexit) Market: IE Agency Approval date: 19/02/2021 (submission date for Type IA) Text Date: 10/02/2021 Text Issue and Draft No.: Issue 5 Draft 1 - 1 - GSK LOGO PACKAGE LEAFLET: INFORMATION FOR THE USER VENTOLIN NEBULES 2.5MG/2.5ML NEBULISER SOLUTION VENTOLIN NEBULES 5 MG/2.5ML NEBULISER SOLUTION SALBUTAMOL (AS SULFATE) 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. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1 What Ventolin Nebules are and what they are used for 2 What you need to know before you take Ventolin Nebules 3 How to use Ventolin Nebules 4 Possible side effects 5 How to store Ventolin Nebules 6 Contents of the pack and other information 1 WHAT VENTOLIN NEBULES ARE AND WHAT THEY ARE USED FOR Ventolin Nebules 2.5mg/2.5ml and 5 mg/2.5ml Nebuliser Solution (called ‘Ventolin Nebules’ in this leaflet) contain 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. Ventolin Nebules are used to treat breathing problems in people with asthma and other chest illnesses. They are usually given to people who suffer seriously from these conditions when other forms of treatment do not help enough. Ventolin Nebules are also given to treat severe attacks of asthma. A Nebule is a small plastic container that contains a liquid. The liquid is put into a machine called a n Aqra d-dokument sħiħ
Health Products Regulatory Authority 08 October 2019 CRN009D3T Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ventolin Nebules 2.5mg/2.5ml Nebuliser Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The concentration of salbutamol is 0.1%. Each nebule contains 2.5 mg Salbutamol (as sulfate). Each ml of solution contains 1 mg Salbutamol (as sulfate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser solution. A clear, colourless to pale yellow, sterile, isotonic, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ventolin Nebules are indicated in adults, adolescents and children 4 to 11 years. For babies and children under 4 years of age, see section 4.2. Ventolin Nebules are indicated for the treatment or routine management of bronchospasm. They provide short acting (four hours) bronchodilation in reversible airways obstruction due to asthma and chronic obstructive pulmonary disease (COPD) such as chronic bronchitis and emphysema. For patients with asthma salbutamol may be used to relieve symptoms when they occur and to manage them prior to a known trigger. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ADULTS AND ADOLESCENTS AGED 12 YEARS AND OVER:_ A suitable starting dose of salbutamol by wet inhalation is 2.5 milligrams. This may be increased to 5 milligrams. Treatment may be repeated up to four times daily. In adult dosing, up to 40 milligrams per day, can be given under strict medical supervision in hospital for the treatment of severe airways obstruction. _Paediatric population _ For children aged 4 to 11 years: A suitable starting dose of salbutamol by wet inhalation is 2.5 milligrams. This may be increased to 5 milligrams. Treatment may be repeated up to four times daily. Other pharmaceutical forms may be more appropriate for administration in children under 4 years old. Clinical efficacy of nebulised salbutamol in infants under 18 months is uncertain. As transient hypoxaemia may occur, supplemental oxygen therapy sh Aqra d-dokument sħiħ