País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
TRAMAZOLINE HYDROCHLORIDE DEXAMETHASONE ISONICOTINATE
Boehringer Ingelheim Limited
120/20 Microgram
Nasal Spray Suspension
1999-03-04
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexa-Rhinaspray Duo 120 micrograms/20 micrograms, Nasal Spray, Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tramazoline hydrochloride 120 micrograms/metered dose and dexamethasone isonicotinate 20 micrograms/metered dose. Also contains 150 micrograms/ml benzalkonium chloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, suspension. A white, homogenous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of allergic rhinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS (INCLUDING THE ELDERLY) 1 metered dose into each nostril up to six times in 24 hours, although 2 or 3 applications a day are usually sufficient. CHILDREN 5-12 years: 1 metered dose into each nostril up to twice daily. Under 5 years: Not recommended. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Each course of treatment should not exceed 14 days. No specific information on the use of this product in the elderly is available. No adverse reactions specific to this age group have been reported with tramazoline and dexamethasone. ADMINISTRATION For detailed information on instructions for use please refer to the Patient Information Leaflet. Shake well each time before use. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/10/2007_ _CRN 2039175_ _page number: 1_ Avoid spraying Dexa-Rhinaspray Duo in or around the eye. Should this occur, immediately flush your eye with cold tap water for several minutes. If the nasal tip becomes clogged, remove the clear plastic dust cap. Hold the nasal tip under running warm tap water for about a minute. Llegiu el document complet