国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUTICASONE FUROATE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
FLUTICASONE FUROATE
60 ACTUATIONS; 120 ACTUATIONS
GLAXO WELLCOME S.A.
_ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ AVAMYS _ _ Fluticasone furoate (27.5 micrograms) 1 WHAT IS IN THIS LEAFLET 1. What AVAMYS is used for 2. How AVAMYS works 3. Before you use AVAMYS 4. How to use AVAMYS 5. While you are using it 6. Side effects 7. Storage and disposal of AVAMYS 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT AVAMYS IS USED FOR AVAMYS nasal spray is used to treat allergic symptoms which include: • Stuffy, runny or itchy nose • Sneezing • Water, itchy or red eyes Symptoms can be seasonal. These are caused by allergies to pollen from grass or trees (hayfever). They can also occur throughout the year and can be caused by animal allergies, house-dust mites or moulds. HOW AVAMYS WORKS AVAMYS belongs to a group of medicines called glucocorticoids. AVAMYS decreases inflammation in the nose and irritation of the eyes caused by allergies (rhinitis). _ _ BEFORE YOU USE AVAMYS _When you must not use it _ _ _ If you are allergic ( _hypersensitive_ ) to fluticasone furoate or any other ingredients of AVAMYS. _Before you start to use it _ _ _ Before you use AVAMYS your doctor needs to know: • If you have liver disease, your doctor may lower your dose of AVAMYS Check with your doctor if you think this may apply to you. If you are pregnant, or think you could be, or if you are planning to become pregnant, don’t take AVAMYS without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking AVAMYS while you’re pregnant. It is not known whether the ingredients of AVAMYS can pass into breast milk. If you are breast-feeding, you must check with your doctor before you take AVAMYS. _Taking other medicines _ _ _ Tell your doctor or pharmacist if you are taking any other medicines, if you’ve taken any recently, or if you start taking new ones. This includes medicine bought without a prescription. Some medicines may affect how AVAMYS works, or make it more likely that you’ll have side 完全なドキュメントを読む
[GSK logo] AVAMYS FLUTICASONE FUROATE QUALITATIVE AND QUANTITATIVE COMPOSITION _AVAMYS _ Nasal Spray is a white, uniform suspension contained in an amber glass bottle, fitted with a metering (50 microlitres) atomising spray pump. This inner pack is incorporated within a predominantly off-white plastic device with a blue side-actuated lever and a lid which contains a stopper. Each spray of the suspension delivers approximately 27.5 micrograms of micronised fluticasone furoate as an ex-device dose. PHARMACEUTICAL FORM Nasal spray, suspension. CLINICAL PARTICULARS INDICATIONS ADULTS AND ADOLESCENTS (12 YEARS AND OLDER) Treatment of the nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) and ocular symptoms (itching/burning, tearing/watering, and redness of the eye) of seasonal allergic rhinitis. Treatment of the nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) of perennial allergic rhinitis. CHILDREN (2 TO 11 YEARS) Treatment of the nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) of seasonal and perennial allergic rhinitis. DOSAGE AND ADMINISTRATION _AVAMYS _ 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. It may take several days of treatment to achieve maximum benefit. An absence of an immediate effect should be explained to the patient ( _see Clinical Studies_ ). POPULATIONS For the treatment of seasonal allergic rhinitis and perennial allergic rhinitis: ADULTS AND ADOLESCENTS (12 YEARS AND OLDER) The recommended starting dosage is 2 sprays (27.5 micrograms per spray) in each nostril once daily (total daily dose, 110 micrograms). Once adequate control of symptoms is achieved, dose reduction to 1 spray in each nostril once daily (total daily dose, 55 micrograms) may be effective for maintenance. CHILDREN (2 TO 11 YEARS) The recommended starting dosage is 1 spray (27.5 microgr 完全なドキュメントを読む