Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
3M Health Care Limited
50 %v/v
Pressurised Inhalation Soln
1999-07-26
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT HFA-134a Beclometasone Dipropionate 50 micrograms Autohaler. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose delivers Beclometasone Dipropionate 50 micrograms ex-valve into the mouthpiece of the actuator. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation solution. Pressurised aluminium container closed with a metering valve and inserted into a breath-actuated beige (cap) and grey (mouthpiece) plastic actuator. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylactic anti-inflammatory treatment of reversible obstructive airway disease. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION NOTE: The recommended total daily dose of beclometasone dipropionate extrafine aerosol from HFA-134a Beclometasone Dipropionate is lower than that for current beclometasone dipropionate CFC product and should be adjusted to the individual patient. HFA-134a Beclometasone Dipropionate is for inhalation use only. ADULTS STARTING AND MAINTENANCE DOSE: For mild to moderate asthma : 50 micrograms to 200 micrograms twice daily. In more severe cases : doses up to 400 micrograms twice daily. The maximum recommended daily dose in adults is 800 micrograms. When patients’ symptoms remain under satisfactory control, the dose can be gradually reduced to the minimum effective dose to maintain control. CHILDREN AGED FIVE YEARS AND OVER – STARTING AND MAINTENANCE DOSE: For mild asthma: 50 micrograms twice daily. Children with well controlled asthma on doses of up to 400 micrograms per day of CFC containing beclometasone dipropionate may be titrated to a dose of 50 micrograms twice daily of HFA-134a Beclometasone Dipropionate. During periods of deterioration in asthma control, the dose may be increased to 100 micrograms twice daily. The dose should be reduced to the minimum Lire le document complet