Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
BUDESONIDE
B & S Healthcare
R03BA02
BUDESONIDE
200 Microgram
Powder for Inhalation
Product subject to prescription which may be renewed (B)
Glucocorticoids
Authorised
2009-07-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pulmicort Turbohaler 200 micrograms, Inhalation Powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 200 micrograms of budesonide For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation Powder Breath actuated metered dose inhaler _Product imported from Poland, Italy and The United Kingdom:_ An opaque plastic metered dose inhaler containing white to off-white spherical granules which break into a fine powder on inhalation 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pulmicort is recommended in patients with bronchial asthma. Pulmicort is indicated for the treatment of chronic obstructive pulmonary disease (COPD). Treatment should be maintained where a beneficial response is obtained during the first 3-6 months of therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Pulmicort Turbohaler is for oral inhalation. COPD Adults (including the elderly): The recommended dose is 400 micrograms twice a day. BRONCHIAL ASTHMA When starting treatment, or during periods of severe asthma and whilst reducing or discontinuing the dosages of oral corticosteroids, the dosage should be adjusted to the individual needs of the patient. Adults: Recommended dosage: 200-1600 micrograms daily. In mild to moderate asthma, a dose of 200-800 micrograms daily, in single or divided doses, may be used. In severe asthma, the daily dosage may be increased to a maximum of 1600 micrograms, in divided doses. Children 5 years of age and above (as children under 5 years may not be able to handle the device properly): Recommended dosage: 200-800 micrograms daily, in single or divided doses. In severe asthma, the daily dosage may be increased to a maximum of 800 micrograms, in divided doses. Elderly: Citiți documentul complet