Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
mometasone furoate, Quantity: 50 microgram/actuation
ORGANON PHARMA PTY LTD
Spray, suspension
Excipient Ingredients: dispersible cellulose; citric acid monohydrate; glycerol; purified water; benzalkonium chloride; citric acid; sodium citrate dihydrate; polysorbate 80
Nasal
65-dose, 40-dose, 140 metered sprays, 2 x 140 dose
(S4) Prescription Only Medicine
For the treatment of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis and the prophylaxis of seasonal allergic rhinitis in adults, adolescents and children between the ages of 3 and 11 years. The treatment of nasal polyps in adult patients 18 years of age and older. For the treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older without the signs and symptoms of severe bacterial infection.
Visual Identification: A white to off-white opaque suspension; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2001-02-14
NASONEX ® AQUEOUS NASAL SPRAY 0.05% _Mometasone Furoate Monohydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about NASONEX. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NASONEX IS USED FOR NASONEX contains the active ingredient mometasone furoate. This belongs to a family of medicines called corticosteroids, which are used to help reduce inflammation. ALLERGIC RHINITIS (HAYFEVER): NASONEX is sprayed into the nose to help relieve symptoms that may occur with hayfever or other year- round allergies, including stuffiness (congestion) in the nose, discharge, itching and sneezing. Your doctor may also prescribe this medicine to help prevent these symptoms two to four weeks before the beginning of the pollen season. NASAL POLYPS: Swollen tissue in the nose can cause grape-like swellings called 'polyps'. Polyps can cause nasal stuffiness, discomfort and loss of smell. NASONEX can be used for the treatment of nasal polyps in patients over 18 years of age. ACUTE RHINOSINUSITIS: Rhinosinusitis is the swelling of the sinuses resulting in stuffiness of the nose, large quantities of mucus from the nose, cough, face pain and/or fever. These symptoms usually last for less than 4 weeks. NASONEX is used to treat the symptoms of rhinosinusitis in adults and children 12 years of age and older, who do not have the signs or symptoms of a severe bacterial infection. YOUR DOCTOR MAY HAVE PRESCRIBED IT FOR ANOTHER REASON. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. There is no evidence that this medicine is addictive. This medicine is available only w Прочитајте комплетан документ
S-CCDS-MK0887-NS-082017 1 AUSTRALIAN PRODUCT INFORMATION – NASONEX ® AQUEOUS NASAL SPRAY 0.05%, ALCOHOL FREE (MOMETASONE FUROATE MONOHYDRATE) 1 NAME OF THE MEDICINE Mometasone furoate (as monohydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NASONEX Aqueous Nasal Spray 0.05% is a metered-dose, manual pump spray unit containing a suspension of mometasone furoate. Each actuation delivers approximately 100 mg of mometasone furoate monohydrate suspension, containing mometasone furoate monohydrate equivalent to mometasone furoate 50 micrograms. NASONEX Aqueous Nasal Spray 0.05% contains mometasone furoate 0.5 mg/g (as the monohydrate). For the full list of excipients, see Section 6.1 LIST OF EXCIPIEINTS. 3 PHARMACEUTICAL FORM Nasal Spray, suspension NASONEX Aqueous Nasal Spray 0.05% does not contain fluorocarbon propellants. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NASONEX Aqueous Nasal Spray 0.05% is indicated for the treatment of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis and the prophylaxis of seasonal allergic rhinitis in adults, adolescents and children between the ages of 3 and 11 years. NASONEX Aqueous Nasal Spray 0.05% is also indicated for the treatment of nasal polyps in adult patients 18 years of age and older. NASONEX Aqueous Nasal Spray 0.05% is indicated for the treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older without signs or symptoms of severe bacterial infection. 4.2 DOSE AND METHOD OF ADMINISTRATION DO NOT EXCEED THE RECOMMENDED DOSAGE. The effect of NASONEX Aqueous Nasal Spray 0.05% is not immediate. Full therapeutic benefit takes a few days to develop. Dosage should be administered as directed and not be taken by the patients at will for symptomatic relief. S-CCDS-MK0887-NS-082017 2 Administration to young children should be aided by an adult. ALLERGIC RHINITIS In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with NASONEX Aqueous Прочитајте комплетан документ