Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
SALBUTAMOL SULFATE
Neutec Inhaler Ireland Limited
R03AC02
SALBUTAMOL SULFATE
Nebuliser solution
salbutamol
Not marketed
2023-06-30
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SALBUTAMOL NEUTEC 2.5 MG 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Salbutamol Neutec is and what it is used for 2. What you need to know before you use Salbutamol Neutec 3. How to use Salbutamol Neutec 4. Possible side effects 5. How to store Salbutamol Neutec 6. Contents of the pack and other information 1. WHAT SALBUTAMOL NEUTEC IS AND WHAT IT IS USED FOR Salbutamol Neutec contains a medicine called salbutamol. This belongs to a group of medicines called short and 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. Salbutamol Neutec is used to treat breathing problems in people with asthma and other lung conditions that cause narrowing of the airways (such as chronic obstructive pulmonary disease). They are usually given to people who suffer seriously from these conditions when other forms of treatment do not seem to work. Salbutamol Neutec can be used to treat adults, adolescents and children, aged 4 to 11 years. Salbutamol Neutec is provided in a small plastic container that contains a liquid. The liquid is put into a machine called a nebuliser. This machine makes a fine mist for you to breathe in through a face mask. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SALBUTAMOL NEUTEC DO NOT USE SALBUTAMOL NEUTEC IF: • you are allergic to salbutamol sulphate Prečítajte si celý dokument
Health Products Regulatory Authority 22 March 2024 CRN00F26G Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salbutamol Neutec 2.5 mg/2.5 ml nebuliser solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 mL single-dose container contains 2.5 mg of salbutamol (as salbutamol sulphate), which is equivalent to 1 mg of salbutamol per 1 mL. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser solution. A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Salbutamol Neutec is indicated in adults, adolescents and children, aged 4 to 11 years. Salbutamol Neutec is indicated for symptomatic treatment of acute reversible airway obstruction in patients with asthma or in patients with severe chronic obstructive pulmonary disease (COPD) when the use of a metered dose inhaler or dry powder inhaler is ineffective or impossible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and adolescents aged 12 years and over_ The starting dose of salbutamol by wet inhalation is 2.5 mg. This may be increased to 5 mg. Treatment may be repeated up to four times daily. In adult dosing, up to 40 mg 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: The starting dose of salbutamol by wet inhalation is 2.5 mg. This may be increased to 5 mg. Treatment may be repeated up to four times daily. Other pharmaceutical forms may be more appropriate for administration in children under 4 years old. As transient hypoxaemia may occur, supplemental oxygen therapy should be considered. _ _ Method of administration Salbutamol inhaled formulations are administered by the inhaled route only, to be breathed in through the mouth with a nebuliser. The solution must not be injected or swallowed. Salbutamol has a duration of action of 4 to 6 hours in most patients. Salbutamol Neutec is intended to be used undiluted. Salbutamol Neutec may be adm Prečítajte si celý dokument