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

cipla australia pty ltd - salmeterol xinafoate, quantity: 0.0725 mg (equivalent: salmeterol, qty 0.05 mg); fluticasone propionate, quantity: 0.5 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 <50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. fluticasone salmeterol ciphaler 500/50 is not indicated for the initiation of bronchodilator therapy in copd.

Hellas - gresk - Εθνικός Οργανισμός Φαρμάκων

ΤΑΡΓΚΕΤ ΦΑΡΜΑ ΜΟΝΟΠΡΟΣΩΠΗ ΕΤΑΙΡΕΙΑ ΠΕΡΙΟΡΙΣΜΕΝΗΣ ΕΥΘΥΝΗΣ Δ.Τ. target pharma ΜΟΝΟΠΡΟΣΩΠΗ ΕΠΕ (0000010744) Μενάνδρου 54,, 104 31, - fluticasone propionate - ΚΡΕΜΑ - 0,05% w/w - 0080474142 fluticasone propionate 0.500000 mg - fluticasone

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

viatris pty ltd - fluticasone propionate, quantity: 50 microgram/actuation; azelastine hydrochloride, quantity: 137 microgram/actuation (equivalent: azelastine, qty 125 microgram/actuation) - spray, nasal - excipient ingredients: glycerol; disodium edetate; phenethyl alcohol; purified water; carmellose sodium; microcrystalline cellulose; polysorbate 80; benzalkonium chloride - symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 12 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.

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

viatris pty ltd - fluticasone propionate, quantity: 50 microgram/actuation; azelastine hydrochloride, quantity: 137 microgram/actuation (equivalent: azelastine, qty 125 microgram/actuation) - spray, nasal - excipient ingredients: disodium edetate; purified water; glycerol; microcrystalline cellulose; polysorbate 80; phenethyl alcohol; benzalkonium chloride; carmellose sodium - symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 12 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.

USA - engelsk - NLM (National Library of Medicine)

clinical solutions wholesale - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 50 ug in 0.1 g

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

aspire pharma ltd - fluticasone propionate - cutaneous cream - 500microgram/1gram

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - fluticasone propionate - cutaneous cream - 500microgram/1gram

USA - engelsk - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate nasal spray, usp 50 mcg per spray 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 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 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, respectively, the maximum recommended human daily intranasal dose (mrhdid) for adults (on a mg/m2 basis at maternal subcutaneous doses of 45 and 100 mcg/kg/day, respectively) showed fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification. no teratogenicity was seen in rats at doses up to 3 times the mrhdid (on a mg/m2 basis at maternal inhalation doses up to 68.7 mcg/kg/day). in rabbits, fetal weight reduction and cleft palate were observed at a fluticasone propionate dose approximately 0.3 times the mrhdid for adults (on a mg/m2 basis at a maternal subcutaneous dose of 4 mcg/kg/day). however, no teratogenic effects were reported at fluticasone propionate doses up to approximately 20 times the mrhdid for adults (on a mg/m2 basis at a maternal oral dose up to 300 mcg/kg/day). no fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration [see clinical pharmacology (12.3)]. fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits. experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. in addition, because there is a natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy. nonteratogenic effects hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. such infants should be carefully monitored. it is not known whether fluticasone propionate is excreted in human breast milk. however, other corticosteroids have been detected in human milk. subcutaneous administration to lactating rats of tritiated fluticasone propionate at a dose approximately 0.4 times the mrhdid for adults on a mg/m2 basis resulted in measurable radioactivity in milk. since there are no data from controlled trials on the use of intranasal fluticasone propionate nasal spray by nursing mothers, caution should be exercised when fluticasone propionate nasal spray is administered to a nursing woman. the safety and effectiveness of fluticasone propionate nasal spray in children aged 4 years and older have been established [see adverse reactions (6.1), clinical pharmacology (12.3)] . six hundred fifty (650) subjects aged 4 to 11 years and 440 subjects aged 12 to 17 years were studied in us clinical trials with fluticasone propionate nasal spray. the safety and effectiveness of fluticasone propionate nasal spray in children younger than 4 years have not been established. effects on growth controlled clinical trials have shown that intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. this effect was observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (hpa) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of hpa axis function. the long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. the potential for "catch-up" growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. the growth of pediatric patients receiving intranasal corticosteroids, including fluticasone propionate nasal spray, should be monitored routinely (e.g., via stadiometry). the potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies. to minimize the systemic effects of intranasal corticosteroids, including fluticasone propionate nasal spray, each patient's dosage should be titrated to the lowest dosage that effectively controls his/her symptoms. a 1-year placebo-controlled trial was conducted in 150 pediatric subjects (aged 3 to 9 years) to assess the effect of fluticasone propionate nasal spray (single daily dose of 200 mcg) on growth velocity. from the primary population receiving fluticasone propionate nasal spray (n = 56) and placebo (n = 52), the point estimate for growth velocity with fluticasone propionate nasal spray was 0.14 cm/year lower than placebo (95% ci: -0.54, 0.27 cm/year). thus, no statistically significant effect on growth was noted compared with placebo. no evidence of clinically relevant changes in hpa axis function or bone mineral density was observed as assessed by 12-hour urinary cortisol excretion and dual-energy x-ray absorptiometry, respectively. the potential for fluticasone propionate nasal spray to cause growth suppression in susceptible patients or when given at higher than recommended dosages cannot be ruled out. a limited number of subjects aged 65 years and older (n = 129) or 75 years and older (n = 11) have been treated with fluticasone propionate nasal spray in clinical trials. while the number of subjects is too small to permit separate analysis of efficacy and safety, the adverse reactions reported in this population were similar to those reported by younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. formal pharmacokinetic trials using fluticasone propionate nasal spray have not been conducted in subjects with hepatic impairment. since fluticasone propionate is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate in plasma. therefore, patients with hepatic disease should be closely monitored. formal pharmacokinetic trials using fluticasone propionate nasal spray have not been conducted in subjects with renal impairment.

USA - engelsk - NLM (National Library of Medicine)

sincerus florida, llc - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4) -

Storbritannia - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - fluticasone propionate - cutaneous cream - 500microgram/1gram