Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
BECLOMETASONE DIPROPIONATE
GlaxoSmithKline (Ireland) Limited
50 Mcg/Acutuation
Nasal Spray Suspension
2000-10-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beconase Aqueous 50 micrograms per metered dose Nasal Spray Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg spray contains beclometasone dipropionate monohydrate equivalent to 50 micrograms of Beclometasone Dipropionate. Excipients: Each 100mg spray contains 20 micrograms of benzalkonium chloride. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, suspension (Nasal Spray) An aqueous, white, opaque suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and treatment of perennial and seasonal allergic and vasomotor rhinitis. Beconase can significantly delay the recurrence of nasal polyps after nasal polypectomy. Where polyps do recur, Beconase can suppress their increase in size. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Beconase is for the administration by the intranasal route only. ADULTS AND CHILDREN OVER 6 YEARS OF AGE: Two applications to each nostril twice daily. In some patients a single application into each nostril three or four times daily may be preferred. The total daily dose should not usually exceed 400 micrograms (8 sprays). CHILDREN UNDER SIX YEARS: There is insufficient clinical data to recommend use. Beconase Aqueous Nasal Spray has a dust cap which protects the nozzle and keeps it clean. Remember to take this off before using the spray. Replace the dust cap after use. A new spray, or one which has not been used for a few days, may not work the first time. You may need to ‘prime’ the bottle by pumping the spray a few times until a fine mist is produced. To do this, hold the bottle as shown. Put your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle. Keeping y Perskaitykite visą dokumentą