Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
FLUTICASONE PROPIONATE
PCO Manufacturing
50 Microgram
Nasal Spray Suspension
2005-12-16
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flixonase 50 micrograms per metered dose, Aqueous nasal spray, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100mg metered dose contains 50 micrograms fluticasone propionate. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, suspension. _Product imported from Belgium:_ A white, opaque aqueous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fluticasone Propionate Aqueous Nasal Spray is indicated for the prophylaxis and treatment of seasonal allergic rhinitis including hay fever, and perennial rhinitis. Fluticasone propionate has potent anti-inflammatory activity but when used topically on the nasal mucosa has no detectable systemic activity. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fluticasone Propionate Aqueous Nasal Spray is for administration by the intranasal route only. _Adults and children over 12 years of age: _For the prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis: Two sprays into each nostril once a day, preferably in the morning. In some cases two sprays into each nostril twice daily may be required. The maximum daily dose should not exceed four sprays into each nostril. _ELDERLY PATIENTS:_ The normal adult dosage is applicable. _CHILDREN UNDER 12 YEARS OF AGE: _For the prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis in children aged 4-11 years:- One spray into each nostril once a day, preferably in the morning. In some cases one spray into each nostril twice daily may be required. The maximum daily dose should not exceed two sprays 4.3 CONTRAINDICATIONS Fluticasone Propionate Aqueous Nasal Spray is contra-indicated in patients with a hypersensitivity to any of its ingredients. IRISH MEDICINES B Les hele dokumentet