Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
fluticasone furoate
GlaxoSmithKline (Ireland) Limited
R01AD12
fluticasone furoate
Nasal preparations, Corticosteroids
Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial
Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
Revision: 22
Authorised
2008-01-11
20 B. PACKAGE LEAFLET 21 PACKAGE LEAFLET: INFORMATION FOR THE USER AVAMYS 27.5 MICROGRAMS PER SPRAY NASAL SPRAY SUSPENSION fluticasone furoate 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 or nurse. - This medicine has been prescribed for you only. Never pass it on to others. It may harm them, even if their signs of illness seem the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET 1. What Avamys is and what it is used for 2. What you need to know before you use Avamys 3. How to use Avamys 4. Possible side effects 5. How to store Avamys 6. Contents of the pack and other information Step-by-step guide to using the nasal spray 1. WHAT AVAMYS IS AND WHAT IT IS USED FOR Avamys (fluticasone furoate) belongs to a group of medicines called _glucocorticoids_. Avamys works to decrease inflammation caused by allergy (_rhinitis_) and therefore reduce symptoms of allergy. Avamys 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 to name some of the most common. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AVAMYS DO NOT USE AVAMYS • IF YOU ARE ALLERGIC to fluticasone furoate or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS CHILDREN AND ADOLESCENTS Do not use in children under 6 years old. 22 Taking Avamys: • may when taken for a long time cause children to grow more slowly. The doctor will check y Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT AVAMYS 27.5 micrograms/spray, nasal spray suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each spray actuation delivers 27.5 micrograms of fluticasone furoate. Excipient with known effect One actuation delivers 8.25 micrograms of benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal spray, suspension. White suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Avamys is indicated in adults, adolescents and children (6 years and over) Avamys is indicated for the treatment of the symptoms of allergic rhinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _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 actuations 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 once daily (total daily dose, 55 micrograms) is recommended. 3 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 info Đọc toàn bộ tài liệu