Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
mometasone (mometasone furoate)
Organon Heist B.V.
R01AD09
mometasone (mometasone furoate)
50mcg/dose
spray nasal (suspension)
18g (140 dose) plastic bottle with spray pump 18g (140 dose)
Prescription
Registered
2024-01-24
2 [Organon] Proprietary SUMMARY OF PRODUCT CHARACTERISTICS 10 [Organon] Proprietary 1. NAME OF THE MEDICINAL PRODUCT NASONEX 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _composition: _one spray dose contains mometasone furoate monohydrate equivalent to 50 mcg mometasone furoate (anhydrous). _excipients: _dispersible cellulose, glycerol, sodium citrate dehydrate, citric acid, polysorbate 80, benzalkonium chloride, purified water. 3. PHARMACEUTICAL FORM A metered-dose nasal spray. _basic physical and chemical properties_: white to off-white powder opaque suspension 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of seasonal allergic or perennial rhinitis in adults and children 2 years of age and older. • In patients 12 years of age and older who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment may be initiated up to 2-4 weeks prior to the anticipated start of the pollen season. • Treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older without signs of severe bacterial infection. • Treatment of nasal polyps and associated symptoms including congestion and loss of smell in adult patients 18 years of age and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Treatment of seasonal or perennial allergic rhinitis: _for adults (including geriatric patients) and children 12 years of age and older the recommended preventive and therapeutic dose is 2 actuations (50 micrograms/actuation) in each nostril once daily (total dose 200 micrograms). Once symptoms are controlled, dose reduction to one actuation in each nostril (total dose 100 micrograms) may be effective for maintenance. If symptoms are inadequately controlled at the recommended therapeutic dose, the daily dose may be increased to a maximum daily dose: of 4 actuations in each nostril once daily (total dose 400 micrograms). Dose reduction is recommended following control of symptoms. This medicinal product demonstrates a clinically significant onset of ac Прочитать полный документ