Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
RPH Pharmaceuticals AB
250 mcg Microgram
Powder for Inhalation
2011-08-19
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Asmabec Clickhaler 250 micrograms Inhalation powder. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered actuation of 6.6 mg contains 250 micrograms of beclometasone dipropionate and delivers 225 micrograms of beclometasone dipropionate. Excipients: includes 6.3 mg of lactose monohydrate per dose. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder. White free-flowing powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Beclometasone Dipropionate is indicated for the control of persistent asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For optimum results Asmabec Clickhaler should be used regularly. The initial dose should be appropriate to the severity of the disease and the maintenance dose titrated to the lowest dose at which effective control of asthma is achieved. Adults: The initial dose for patients with mild asthma is 200 to 400 micrograms per day; this may be increased to 800 micrograms per day if required. For patients with moderate asthma and severe asthma the initial dose can be 800 to 1600 micrograms per day, increased to 2000 micrograms in severe cases. The normal maximum daily dose for adults is 2000 micrograms. The maintenance dose is normally 200 to 400 micrograms twice daily. If necessary the dose may be increased to 1600 to 2000 micrograms per day divided into two to four doses and be reduced later when asthma is stabilised. SPECIAL POPULATION There are no special dosage recommendations for elderly patients. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/03/2012_ _CRN 2112755_ _page number: 1_ PAEDIATRIC POPULATION Children aged 6 - 12 years: Up to Pročitajte cijeli dokument