מדינה: הולנד
שפה: הולנדית
מקור: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AZELASTINEHYDROCHLORIDE 1000 mg/g SAMENSTELLING overeenkomend met ; AZELASTINE 0,913 mg/g ; FLUTICASONPROPIONAAT 0,365 mg/g
AZELASTINEHYDROCHLORIDE 1000 mg/g SAMENSTELLING overeenkomend met ; AZELASTINE 0,913 mg/g ; FLUTICASONPROPIONAAT 0,365 mg/g
Neusspray, suspensie
BENZALKONIUMCHLORIDE ; CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; DINATRIUMEDETAAT 2-WATER ; FENYLETHYLALCOHOL ; GLYCEROL (E 422) ; POLYSORBAAT 80 (E 433) ; WATER, GEZUIVERD, BENZALKONIUMCHLORIDE ; CARMELLOSE NATRIUM (E 466) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; DINATRIUMEDETAAT 2-WATER ; FENYLETHYLALCOHOL ; GLYCEROL (E 422) ; POLYSORBAAT 80 (E 433) ; WATER, GEZUIVERD
Nasaal gebruik
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AZELASTINE/FLUTICASONPROPIONAAT WIN MEDICA 137 MICROGRAM / 50 MICROGRAM PER VERSTUIVING, NEUSSPRAY, SUSPENSIE azelastine hydrochloride/fluticasone propionate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WhatNasal Spray is and what it is used for 2. What you need to know before you use קרא את המסמך השלםNasal Spray 3. How to use Nasal Spray 4. Possible side effects 5. How to store Nasal Spray 6. Contents of the pack and other information 1. WHAT NASAL SPRAY IS AND WHAT IT IS USED FOR Nasal Spray contains two active substances: azelastine hydrochloride and fluticasone propionate. • Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction – thus reducing symptoms of allergic rhinitis. • Fluticasone propionate belongs to a group of medicines called corticosteroids which reduces inflammation. Nasal Spray is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis if the use of either intranasal antihistamine or corticosteroid alone is not considered sufficient. Seasonal and perennial allergic rhinitis are allergic reactions to substances such as pollen (hayfever), house mites, moulds, dust or pets. Nasal Spray relieves the symptoms of allergies,
SAMENVATTING VAN DE PRODUCTKENMERKEN 1. NAAM VAN HET GENEESMIDDEL Azelastine/Fluticasonpropionaat Win Medica 137 microgram / 50 microgram per verstuiving, neusspray, suspensie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each g of suspension contains 1000 micrograms azelastine hydrochloride and 365 micrograms fluticasone propionate. One actuation (0.14 g) delivers 137 micrograms azelastine hydrochloride (= 125 micrograms azelastine) and 50 micrograms fluticasone propionate. Excipient with known effect: One actuation (0.14 g) delivers 0.014 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, suspension. White, homogeneous suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY _ For full therapeutic benefit regular usage is essential. Contact with the eyes should be avoided. Adults and adolescents (12 years and older) One actuation in each nostril twice daily (morning and evening). Children below 12 yearsNasal Spray is not recommended for use in children below 12 years of age as safety and efficacy has not been established in this age group. Elderly No dose adjustment is required in this population. Renal and hepatic impairment There are no data in patients with renal and hepatic impairment. _DURATION OF TREATMENT _ קרא את המסמך השלםNasal Spray is suitable for long-term use. The duration of treatment should correspond to the period of allergenic exposure. _METHOD OF ADMINISTRATION _ Nasal Spray is for nasal use only. _INSTRUCTION FOR USE _ Preparing the spray: The bottle should be shaken gently before use for about 5 seconds by tilting it upwards and downwards and the protective cap be removed afterwards. Prior to first use Nasal Spray must be primed by pressing down and