Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Salbutamol
Valeas SPA Industria Chimica e Farmaceutica
R03AC; R03AC02
Salbutamol
100 microgram(s)
Pressurised inhalation, suspension
Product subject to prescription which may be renewed (B)
Selective beta-2-adrenoreceptor agonists; salbutamol
Not marketed
2011-07-27
Health Products Regulatory Authority 12 November 2020 CRN00C14M Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Salbutamol CFC-Free Inhaler 100 micrograms per metered dose, pressurised inhalation, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose contains 100 micrograms of salbutamol (equivalent to 120 micrograms of salbutamol sulphate). This is equivalent to a delivered dose of 90 micrograms of salbutamol (equivalent to 108 micrograms of salbutamol sulphate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation suspension Pressurised inhalation suspension supplied in an aluminium canister with a metering valve and a plastic actuator and dust cap. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Salbutamol CFC-Free Inhaler is indicated in adults, adolescents and children. For babies and children under 4 years of age, see sections 4.2 and 5.1. Salbutamol CFC-Free Inhaler is indicated for the relief and prevention of bronchial asthma and conditions associated with reversible airways obstruction. Salbutamol CFC-Free Inhaler can be used as relief medication in the management of mild, moderate or severe asthma, provided that its use does not delay the introduction and use of regular inhaled corticosteroid therapy, where necessary. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Salbutamol CFC-Free Inhaler is for oral inhalation use only. Posology ADULTS (INCLUDING THE ELDERLY) AND ADOLESCENTS (CHILDREN 12 YEARS AND OVER): For the relief of acute bronchospasm, one inhalation (100 micrograms) increasing to two inhalations (200 micrograms), if necessary. To prevent allergen- or exercise-induced symptoms, two inhalations (200 micrograms) should be taken 10-15 minutes before challenge. Maximum daily dose: two inhalations (200 micrograms) up to four times a day. PAEDIATRIC POPULATION: Babies and young children using Salbutamol CFC-Free Inhaler may benefit from the use of a paediatric spacer device with a face mask (for example the BABY Soma hati kamili