Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
FLUTICASONE FUROATE
GLAXO SMITH KLINE (ISRAEL) LTD
R01AD12
SPRAY
FLUTICASONE FUROATE 27.5 MCG/DOSE
NASAL
Required
GLAXO OPERATIONS (UK) LIMITED
FLUTICASONE
FLUTICASONE FUROATE
AVAMYS (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.
2014-10-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a physician's prescription only AVAMYS NASAL SPRAY EACH SPRAY RELEASES FLUTICASONE FUROATE 27.5 MCG The list of additional ingredients is detailed in section 6. Pay attention to the important information about some of the ingredients of the medicine in section 2. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or the pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Avamys is intended for the treatment of symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older. THERAPEUTIC GROUP: Corticosteroids Avamys is used to treat symptoms of allergic rhinitis including: stuffy nose, runny nose, itchy nose, sneezing, and watery, itchy and red eyes. Avamys contains the active ingredient fluticasone furoate. This medicine belongs to a group of medicines known as corticosteroids, which are frequently called “steroids”. These are not “anabolic steroids” which athletes often abuse. Avamys reduces the inflammation caused by allergy (rhinitis). Avamys is not addictive. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are sensitive (allergic) to the active ingredient or to any of the additional ingredients contained in the medicine as detailed in section 6. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE BEGINNING TREATMENT WITH AVAMYS, TELL YOUR PHYSICIAN IF: • you are allergic to foods, dyes, preservatives or other medicines. DURING THE COURSE OF TREATMENT WITH AVAMYS, REFER TO YOUR PHYSICIAN IF: • you experience vision changes. CHILDREN AND ADOLESCENTS Avamys is not intended for children under two years of age. DRUG INTERACTIONS IF YOU ARE TAK Perskaitykite visą dokumentą
1 AVAMYS 1. NAME OF THE MEDICINE AVAMYS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AVAMYS Nasal Spray is a white suspension of micronised fluticasone furoate for topical administration to the nasal mucosa by means of a metering atomising spray pump. Each spray of the suspension delivers approximately 27.5 micrograms of micronised fluticasone furoate as an ex-device dose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Spray 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AVAMYS (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older. 4.2 DOSE AND METHOD OF ADMINISTRATION Administer AVAMYS Nasal Spray by the intranasal route only. Prime AVAMYS Nasal Spray before using for the first time by shaking the contents well and releasing 6 sprays into the air away from the face. When AVAMYS Nasal Spray has not been used for more than 30 days or if the cap has been left off the bottle for 5 days or longer, prime the pump again until a fine mist appears. Shake AVAMYS Nasal Spray well before each use. Titrate an individual patient to the minimum effective dosage to reduce the possibility of side effects. ADULTS AND ADOLESCENTS AGED 12 YEARS AND OLDER The recommended starting dosage is 110 mcg once daily administered as 2 sprays (27.5 mcg/spray) in each nostril. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage to 55 mcg (1 spray in each nostril) once daily may be effective in maintaining control of allergic rhinitis symptoms. CHILDREN AGED 2 TO 11 YEARS The recommended starting dosage in children is 55 mcg once daily administered as 2 1 spray (27.5 mcg/spray) in each nostril. Children not adequately responding to 55 mcg may use 110 mcg (2 sprays in each nostril) once daily. Once symptoms have been controlled, dosage reduction to 55 mcg once daily is recommended. 4.3 CONTRAINDICATIONS AVAMYS is contraindicated in patients with a Perskaitykite visą dokumentą