Australia - engelsk - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - salmeterol xinafoate, quantity: 0.0725 mg; fluticasone propionate, quantity: 0.25 mg - inhalation, powder for - excipient ingredients: lactose monohydrate - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include ? patients on effective maintenance doses of long acting beta 2 agonists and inhaled corticosteroids ? patients who are symptomatic on current inhaled corticosteroid therapy for the symptomatic treatment of patients with severe copd (fev1 not more than 50 per cent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta 2 agonist bronchodilator therapy. fluticasone salmeterol cip haler 250/50 is not indicated for the initiation of bronchodilator therapy in copd.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - salmeterol xinafoate, quantity: 0.0725 mg; fluticasone propionate, quantity: 0.25 mg - inhalation, powder for - excipient ingredients: lactose monohydrate - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include ? patients on effective maintenance doses of long acting beta 2 agonists and inhaled corticosteroids ? patients who are symptomatic on current inhaled corticosteroid therapy for the symptomatic treatment of patients with severe copd (fev1 not more than 50 per cent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta 2 agonist bronchodilator therapy. fluticasone salmeterol multi haler 250/50 is not indicated for the initiation of bronchodilator therapy in copd

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

haleon new zealand ulc - fluticasone propionate 0.05%{relative};   - nasal spray suspension - 0.05% w/w - active: fluticasone propionate 0.05%{relative}   excipient: benzalkonium chloride dispersible cellulose glucose hydrochloric acid phenethyl alcohol polysorbate 80 purified water - flixonase allergy & hayfever 24 hour is indicated for the prophylaxis and treatment of allergic rhinitis including hay fever and that caused by other airborne allergens such as house dust mite, mould spores and animal dander. during treatment flixonase allergy & hayfever 24 hour provides symptomatic relief of sneezing, itchy and runny nose, congestion including associated sinus discomfort and pressure around the nose and eyes. flixonase allergy & hayfever 24 hour also provides relief of ocular symptoms associated with allergic rhinitis.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - salmeterol xinafoate, quantity: 36.32 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation); fluticasone propionate, quantity: 250 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include: - patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids. - patients who are symptomatic on current inhaled corticosteroid therapy.,for the symptomatic treatment of patients with severe copd (fev1 less than 50 precent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. fluticasone propionate/salmeterol (125 microgram/25 microgram and 250 microgram/25 microgram) is not indicated for the initiation of bronchodilator therapy in copd.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - salmeterol xinafoate, quantity: 36.32 microgram/actuation (equivalent: salmeterol, qty 25 microgram/actuation); fluticasone propionate, quantity: 125 microgram/actuation - inhalation, pressurised - excipient ingredients: norflurane - for the regular treatment of asthma, where the use of a combination product is appropriate. this may include: - patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids. - patients who are symptomatic on current inhaled corticosteroid therapy.,for the symptomatic treatment of patients with severe copd (fev1 less than 50 precent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. fluticasone propionate/salmeterol (125 microgram/25 microgram and 250 microgram/25 microgram) is not indicated for the initiation of bronchodilator therapy in copd.

USA - engelsk - NLM (National Library of Medicine)

remedyrepack inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug in 0.1 g - fluticasone propionate nasal spray, usp is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. fluticasone propionate nasal spray, usp is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.3) , description (11) ]. teratogenic effects pregnancy category c. there are no adequate and well-controlled trials with fluticasone propionate nasal spray, usp in pregnant women. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. because animal reproduction studies are not always predictive of human response, fluticasone propionate nasal spray, usp should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. women should be advised to contact their physicians if they become pregnant while taking fluticasone propionate nasal spray, usp. mice and rat

USA - engelsk - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug - fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients aged 4 years and older. fluticasone propionate nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.3) , description (11)] . there are no adequate and well-controlled trials with fluticasone propionate nasal spray in pregnant women. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. because animal reproduction studies are not always predictive of human response, fluticasone propionate nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. women should be advised to contact their physicians if they become pregnant while taking fluticasone propionate nasal spray. mice and rats at fluticasone propionate doses approximately 1 and 4 times, respect

USA - engelsk - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug in 0.1 g - fluticasone propionate nasal spray, usp is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older. fluticasone propionate nasal spray, usp is contraindicated in patients with hypersensitivity to any of its ingredients [see warnings and precautions (5.3) , description (11) ]. teratogenic effects pregnancy category c. there are no adequate and well-controlled trials with fluticasone propionate nasal spray, usp in pregnant women. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. because animal reproduction studies are not always predictive of human response, fluticasone propionate nasal spray, usp should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. women should be advised to contact their physicians if they become pregnant while taking fluticasone propionate nasal spray, usp. mice and rats at

USA - engelsk - NLM (National Library of Medicine)

fougera pharmaceuticals inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 0.5 mg in 1 ml - fluticasone propionate lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age or older. none. pregnancy category c there are no adequate and well-controlled studies in pregnant women. therefore, fluticasone propionate lotion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. systemic embryofetal development studies were conducted in mice, rats and rabbits. subcutaneous doses of 15, 45 and 150 μg/kg/day of fluticasone propionate were administered to pregnant female mice from gestation days 6 to 15. a teratogenic effect characteristic of corticosteroids (cleft palate) was noted after administration of 45 and 150 μg/kg/day (less than the mrhd in adults based on body surface area comparisons) in this study. no treatment related effects on embryofetal toxicity or teratogenicity were noted at 15 μg/kg/day (less than the mrhd in adults based on body surface area compar

USA - engelsk - NLM (National Library of Medicine)

e. fougera & co. a division of fougera pharmaceuticals inc. - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 0.5 mg in 1 g - fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. the safety and efficacy of drug use for longer than 4 weeks in this population have not been established. the safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established. fluticasone propionate cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.