国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Mometasone furoate
IMED Healthcare Ltd.
R01AD09
Mometasone furoate
50 microgram(s)
Nasal spray, suspension
Nasal
18g bottle
Product subject to prescription which may not be renewed (A)
Schering-Plough Labo NV
Decongestants and Other Nasal Preparations for Topical Use-Corticosteroids
mometasone
It is indicated for use in adults and children 12 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis.
Authorised
2015-05-22
PACKAGE LEAFLET: INFORMATION FOR THE USER NASONEX ® 50 MICROGRAMS/ACTUATION NASAL SPRAY, SUSPENSION mometasone furoate PLEASE READ 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. 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 Nasonex is and what it is used for 2. What you need to know before you use Nasonex 3. How to use Nasonex 4. Possible side effects 5. How to store Nasonex 6. Contents of the pack and other information 1. WHAT NASONEX IS AND WHAT IT IS USED FOR WHAT IS NASONEX? Nasonex Nasal Spray contains mometasone furoate, one of a group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it can help to relieve inflammation (swelling and irritation of the nose), sneezing, itching and a blocked up or runny nose. WHAT IS NASONEX USED FOR? Hay fever and perennial rhinitis Nasonex is used to treat the symptoms of hayfever (also called seasonal allergic rhinitis) and perennial rhinitis in adults and children aged 3 and older. Hayfever, which occurs at certain times of the year, is an allergic reaction caused by breathing in pollen from trees, grasses, weeds and also moulds and fungal spores. Perennial rhinitis occurs throughout the year and symptoms can be caused by a sensitivity to a variety of things including house dust mite, animal hair (or dander), feathers and certain foods. Nasonex reduces the swelling and irritation in your nose and thereby relieving sneezing, itching and a blocked-up or runny nose caused by hay fever or perennial rhinitis. Nasal polyps Nasonex is used to treat nasal polyps in adults aged 18 and ov 完全なドキュメントを読む
Health Products Regulatory Authority 28 March 2023 CRN00DGKS Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NASONEX 50 micrograms/actuation Nasal Spray, Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mometasone furoate (as the monohydrate) 50 micrograms/actuation. Excipient with known effect This medicinal product contains benzalkonium chloride _For the full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Nasal Spray, Suspension. _Product imported from Greece and Romania._ White to off-white opaque suspension. 4 CLINICAL PARTICULARS As per PA23198/011/001 5 PHARMACOLOGICAL PROPERTIES As per PA23198/011/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS _Product imported from Greece:_ dispersible cellulose 65 cps (microcrystalline cellulose and carmellose sodium) glycerol sodium citrate citric acid monohydrate polysorbate 80 benzalkonium chloride purified water _Product imported from Romania:_ Dispersable cellulose (microcrystalline cellulose and sodium carmellose) Glycerol Sodium citrate dihydrate Citric acid monohydrate Polysorbate 80 Benzalkonium chloride Purified water 6.2 INCOMPATIBILITIES Not applicable. Health Products Regulatory Authority 28 March 2023 CRN00DGKS Page 2 of 2 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer carton of the product on the market in the country of origin. Use within 2 months of first use. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Do not freeze. 6.5 NATURE AND CONTENTS OF CONTAINER NASONEX Nasal Spray is contained in a white, high density polyethylene bottle, that contains 18 g (140 actuations) of product formulation, supplied with a metered-dose, manual polypropylene spray pump actuator. Pack sizes: 18g: 1 bottle 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane 完全なドキュメントを読む