국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
fluticasone furoate
Glaxo Group Ltd.
R01AD12
fluticasone furoate
Nasal preparations
Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.
Revision: 4
Withdrawn
2008-10-06
MEDICINAL PRODUCT NO LONGER AUTHORISED 16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INTRANASAL SPRAY/DEVICE LABEL 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Alisade 27.5 micrograms/spray nasal spray suspension Fluticasone fuorate 2. METHOD OF ADMINISTRATION Read the package leaflet before use 3. EXPIRY DATE _ _ _EXP {MM/YYYY]_ 4. BATCH NUMBER _ _ _LOT {Number}_ 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 sprays 60 sprays 120 sprays 6. OTHER MEDICINAL PRODUCT NO LONGER AUTHORISED 17 B. PACKAGE LEAFLET MEDICINAL PRODUCT NO LONGER AUTHORISED 18 PACKAGE LEAFLET: INFORMATION FOR THE USER ALISADE 27.5 MICROGRAMS PER SPRAY NASAL SPRAY SUSPENSION Fluticasone furoate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Never pass it on to others. It may harm them, even if their symptoms seem the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. IN THIS LEAFLET : 1. WHAT ALISADE IS AND WHAT IT IS USED FOR 2. BEFORE YOU USE ALISADE 3. HOW TO USE ALISADE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ALISADE 6. FURTHER INFORMATION STEP-BY-STEP GUIDE TO USING THE NASAL SPRAY 1. WHAT ALISADE IS AND WHAT IT IS USED FOR Alisade nasal spray is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing and watery, itchy or red eyes, in adults and children aged 6 years and over. Allergy symptoms can occur at specific times of the year and be caused by allergy to pollen from grass or trees (hayfever), or they can occur all year round and be caused by allergy to animals, house-dust mites or moulds. Alisade belongs to a group of medicines called _glucocorticoids_ . Alisade works to decrease inflammation caused by allergy ( _rhinitis_ ). 2. BEFORE YOU USE ALISADE DO NOT USE ALISAD 전체 문서 읽기
MEDICINAL PRODUCT NO LONGER AUTHORISED 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS MEDICINAL PRODUCT NO LONGER AUTHORISED 2 1. NAME OF THE MEDICINAL PRODUCT ALISADE 27.5 micrograms/spray nasal spray suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each spray actuation delivers 27.5 micrograms of fluticasone furoate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, suspension. White suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults, adolescents (12 years and over) and children (6 – 11 years) Alisade is indicated for the treatment of: • the symptoms of allergic rhinitis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fluticasone furoate nasal spray is for administration by the intranasal route only. For full therapeutic benefit regular, scheduled usage is recommended. Onset of action has been observed as early as 8 hours after initial administration. However, it may take several days of treatment to achieve maximum benefit, and the patient should be informed that their symptoms will improve with continuous regular use (see section 5.1). The duration of treatment should be restricted to the period that corresponds to allergenic exposure. Adults and Adolescents (12 years and over) The recommended starting dose is two spray actuations (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 110 micrograms). Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril (total daily dose 55 micrograms) may be effective for maintenance. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Children (6 to 11 years of age) The recommended starting dose is one spray actuation (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55 micrograms). Patients not adequately responding to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) may use two spray 전체 문서 읽기