Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
BUDESONIDE
AstraZeneca UK Limited
200 Mcg/Acutuation
Pressurised Inhalation Suspension
1999-01-30
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pulmicort 200 micrograms Inhaler 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains budesonide 200 micrograms. For excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension Metered dose aerosol consisting of a 10 ml aluminium vial and a 50 microlitre metering value, available with standard adapter or spacer adapter. May also be administered via Nebuhaler®. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of bronchial asthma, not previously well controlled on bronchodilators and/or anti-allergic agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children 12 years and over: 200 micrograms twice daily, in the morning and in the evening. During periods of severe asthma the daily dose can be increased up to 1600 micrograms. In patients whose asthma is well controlled, the daily dose may be reduced below 400 micrograms but should not go below 200 micrograms. Budesonide should not be relied upon to control an acute asthmatic attack. Children under 12 years: 50 to 400 micrograms to be given twice daily, i.e. maximum dosage 800 micrograms /day. Elderly: Dosage as for adults. The dose should be reduced to the minimum needed to maintain good asthma control. ONSET OF EFFECT Improvement in asthma control following inhaled administration of Pulmicort pMDI can occur within 24 hours of initiation of treatment, although peak effect may not be achieved for 1 to 2 weeks or longer after starting treatment. PATIENTS MAINTAINED ON ORAL GLUCOCORTICOSTEROIDS Pulmicort Inhaler may permit replacement or significant reduction in the dosage of oral glucocorticosteroids with maintained or improved asthma control. IRISH MEDICINES BOARD __________________________ Lire le document complet