FLIXONASE AQUEOUS
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
03-05-2024
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Virkt innihaldsefni:
FLUTICASONE PROPIONATE
Fáanlegur frá:
PCO Manufacturing
Skammtar:
50 Microgram
Lyfjaform:
Nasal Spray Suspension
Leyfisdagur:
2012-01-20
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flixonase Aqueous 50 micrograms per metered dose, nasal spray, suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered spray contains 50 micrograms of fluticasone propionate.
Excipients: also contains Benzalkonium chloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, suspension.
Product imported from Poland:
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 into each nostril.
For full therapeutic benefit regular usage is essential. The absence of an immediate effect
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