国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Azelastine hydrochloride; Fluticasone propionate
Mylan IRE Healthcare Limited
R01AD; R01AD58
Azelastine hydrochloride; Fluticasone propionate
137 µg/50 microgram(s)
Nasal spray, suspension
Corticosteroids; fluticasone, combinations
Not marketed
2013-02-22
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AZECORT 137 MICROGRAMS / 50 MICROGRAMS PER ACTUATION NASAL SPRAY, SUSPENSION 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. What Azecort is and what it is used for 2. What you need to know before you use Azecort 3. How to use Azecort 4. Possible side effects 5. How to store Azecort 6. Contents of the pack and other information 1. WHAT AZECORT IS AND WHAT IT IS USED FOR Azecort 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. Azecort is used for the symptomatic treatment of severe hay fever (seasonal allergic rhinitis) in adults. Seasonal allergic rhinitis is an allergic reaction to substances such as pollen (hayfever). Azecort relieves the symptoms of seasonal allergies, for example: runny nose, post nasal drip, sneezing and itchy or blocked nose. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AZECORT DO NOT USE AZECORT: • if you are allergic to azelastine hydrochloride or fluticasone propionate or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUT 完全なドキュメントを読む
Health Products Regulatory Authority 02 March 2022 CRN00CDND Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azecort 137 micrograms/50 micrograms per actuation nasal spray, suspension 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 For symptomatic treatment of severe seasonal allergic rhinitis in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For full therapeutic benefit regular usage is essential. Contact with the eyes should be avoided. _ _ _Adults_ One actuation in each nostril twice daily (morning and evening). _Paediatric population_ Azecort should not be used in children and adolescents under 18 years of age. _Elderly_ No dose adjustment is required in this population. _Renal and hepatic impairment_ There are no data in patients with renal and hepatic impairment (see section 4.4). _ _ _Duration of treatment_ Azecort is suitable for long-term use. The duration of treatment should correspond to the period of allergenic exposure. Method of administration Azecort is for nasal use only. _INSTRUCTION FOR USE_ Preparing the spray: Health Products Regulatory Authority 02 March 2022 CRN00CDND Page 2 of 8 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 Azecort must be primed by pressing down and releasing the pump 6 times. If Azecort has not been used for more than 7 days it must be reprimed once by pressing down and releasing the pump. Using 完全なドキュメントを読む