ประเทศ: ไอร์แลนด์
ภาษา: อังกฤษ
แหล่งที่มา: HPRA (Health Products Regulatory Authority)
SALBUTAMOL SULFATE
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
R03AC02
SALBUTAMOL SULFATE
2.5/2.5 Mg/Ml
Nebuliser Solution
Product subject to prescription which may be renewed (B)
salbutamol
Marketed
1992-11-16
PACKAGE LEAFLET: INFORMATION FOR THE USER 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 SALAMOL STERI-NEB IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SALAMOL STERI-NEB 3. HOW TO USE SALAMOL STERI-NEB 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SALAMOL STERI-NEB 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT SALAMOL STERI-NEB IS AND WHAT IT IS USED FOR Your medicine is called Salamol Steri-Neb 2.5 mg/2.5 ml Nebuliser Solution (referred to as Salamol Steri-Neb throughout this leaflet). It contains a substance called salbutamol, which belongs to a class of medicines called bronchodilators. Bronchodilators help manage BRONCHOSPASM (sudden narrowing of the tubes to the lungs caused by muscle spasm), by opening up the air passages in the lungs for up to 4 – 6 hours after administration. Salamol Steri-Neb is used to treat: • ASTHMA • CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), such as chronic bronchitis and emphysema. If you suffer from asthma, Salamol Steri-Neb can be used to both manage the symptoms before they occur and to relieve symptoms once they occur. Salamol Steri-Neb is for use in adults, adolescents and children aged 4 to 11 years (see section 3, “How to use Salamol Steri-Neb”). 2 WHAT YOU NEED TO KNOW BEFORE YOU USE SALAMOL STERI-NEB DO NOT USE SALAMOL STERI-NEB: • if you are allergic to salbutamol or any of the other ingredients of this medicine (listed in section 6) • for the general management of premature labour or threat อ่านเอกสารฉบับเต็ม
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salamol Steri-Neb 2.5 mg/2.5 ml Nebuliser Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Steri-Neb nebuliser solution (2.5ml) contains Salbutamol Sulphate equivalent to 2.5 mg salbutamol (1mg/ml). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser solution. Clear, colourless to pale yellow, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Salamol Steri-Nebs 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. Salamol Steri-Nebs are indicated in adults, adolescents and children 4 to 11 years. For babies and children under 4 years of age, see section 4.2. 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. The maximum daily dose in adults is normally 20 mg/day. 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 should be considered. H E A L T H P R O D U C T S R E G U L A T O R Y A U T อ่านเอกสารฉบับเต็ม