Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MOMETASONE FUROATE
ORGANON MALAYSIA SDN. BHD.
MOMETASONE FUROATE
40Units Units; 60Units Units; 120Units Units; 140Units Units; 40 Units; 60 Units; 120 Units; 140 Units
Organon Heist bv
Copyright 2023 Organon group of companies. All rights reserved. NASONEX ® Aqueous Nasal Spray LPC-OG0887-NS-082017 Brand of mometasone furoate monohydrate FOR INTRANASAL ADMINISTRATION DESCRIPTION: NASONEX Aqueous Nasal Spray is a metered-dose, manual pump spray unit containing a suspension of mometasone furoate. Each metered-dose pump actuation of NASONEX Aqueous Nasal Spray delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate. Inactive ingredients: Cellulose, glycerol, citric acid monohydrate, sodium citrate dihydrate, polysorbate 80, benzalkonium chloride and purified water. Preservatives: benzalkonium chloride 0.2 mg/g. ACTIONS: Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active. PRECLINICAL PHARMACOLOGY AND TOXICOLOGY: Preclinical studies demonstrate that mometasone furoate is devoid of androgenic, antiandrogenic, estrogenic or antiestrogenic activity but, like other glucocorticoids, it possesses some antiuterotrophic activity and delays vaginal opening in animal models at high oral doses of 56 mg/kg/day and 280 mg/kg/day. In cell culture, mometasone furoate was shown to be at least ten times more potent than other steroids, including beclomethasone dipropionate (BDP), betamethasone, hydrocortisone and dexamethasone, at inhibiting the synthesis/release of IL-1, IL-6 and TNF α . Mometasone furoate (IC 50 = 0.12 Nm) was also at least six times more potent than BDP and betamethasone at inhibiting IL-5 production. Also, in mixed leukocytes from atopic patients, mometasone was a more potent leukotriene production inhibitor than BDP. In a preclinical model, the compound has been shown to reduce the accumulation of eosinophils markedly at the site of an allergic reaction. For example, in allergic mice with IgE-mediated allergy, inhaled mometasone furoate at doses as low as 13 micrograms/kg inhibited eosinophil infiltration into bronc Прочетете целия документ