Malaysia - engelsk - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

hyphens pharma sdn. bhd. - fluocinolone acetonide; ciprofloxacin -

Canada - engelsk - Health Canada

medicis canada ltd. - fluocinolone acetonide; neomycin (neomycin sulfate); polymyxin b sulfate - solution - 0.25mg; 3.5mg; 10000unit - fluocinolone acetonide 0.25mg; neomycin (neomycin sulfate) 3.5mg; polymyxin b sulfate 10000unit - antibacterials

USA - engelsk - NLM (National Library of Medicine)

alimera sciences, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.19 mg - iluvien® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (dme) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. iluvien is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases. iluvien is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8. iluvien is contraindicated in patients with known hypersensitivity to any components of this product. pregnancy category c there are no adequate and well-controlled studies of iluvien in pregnant women. animal reproduction studies have not been conducted with fluocinolone acetonide. corticosteroids have been shown to be teratogenic in labor

USA - engelsk - NLM (National Library of Medicine)

solutech pharmaceuticals llc - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.1 mg in 1 ml - do not use if known hypersensitivity to any of the listed ingredients of any of the components included in the kit. fluocinolone acetonide topical solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of components of the preparation. contraindicated in patients with known hypersensitivity to any of the listed ingredients. for alleviating tension on the scar and its surrounding skin. tension on a wound and scar is known to increase scar tissue formation. because of its adherence, silicone tape reduces tension (e.g. tear and stretch) along the incision line or wound which is known to minimize the degree of scarring in terms of spreading or thickening.

USA - engelsk - NLM (National Library of Medicine)

solutech pharmaceuticals llc - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.1 mg in 1 ml - do not use if known hypersensitivity to any of the listed ingredients of any of the components included on the kit. fluocinolone acetonide topical solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of components of the preparation. keratolytic for alleviating tension on the scar and its surrounding skin. tension on a wound and scar is known to increase scar tissue formation. because of its adherence, silicone tape reduces tension (e.g. tear and stretch) along the incision line or wound which is known to minimize the degree of scarring in terms of spreading or thickening.

USA - engelsk - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide topical solution usp, 0.01% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients. fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. safety and effectiveness in pediatric patients younger than 3 months of age have not been established. apply the least amount of fluocinolone acetonide topical oil, 0.01% needed to cover the affected areas. as with other corticosteroids, fluocinolone acetonide topical oil, 0.01% should be discontinued when control of disease is achieved. contact the physician if no improvement is seen within 2 weeks. fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. fluocinolone acetonide topical oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician. application to intertriginous areas should be avoided due to the increased risk of local adverse reactions. [see adverse reactions (6) and use in specific populations (8.4)] . none pregnancy category c: corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. there are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide topical oil, 0.01%. therefore, fluocinolone acetonide topical oil, 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when fluocinolone acetonide topical oil, 0.01% is administered to a nursing woman. 8.4.1 systemic adverse reactions in pediatric patients hpa axis suppression, cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. because of a higher ratio of skin surface area to body mass, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids. [see warnings and precautions (5.1)] 8.4.2 evaluation in peanut-sensitive pediatric subjects a clinical study was conducted to assess the safety of fluocinolone acetonide topical oil, 0.01%, which contains refined peanut oil, on subjects with known peanut allergies. the study enrolled 13 subjects with atopic dermatitis, 6 to 17 years of age. of the 13 subjects, 9 were radioallergosorbent test (rast) positive to peanuts and 4 had no peanut sensitivity (controls). the study evaluated the subjects’ responses to both prick test and patch test utilizing peanut oil nf, fluocinolone acetonide topical oil, 0.01% and histamine/saline controls. subjects were also treated with fluocinolone acetonide topical oil, 0.01% twice daily for 7 days. prick test and patch test results for all 13 patients were negative to fluocinolone acetonide topical oil, 0.01% and the refined peanut oil. one of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide topical oil, 0.01%. the bulk peanut oil nf, used in fluocinolone acetonide topical oil, 0.01% is heated just below 450°f for at least 30 minutes, which should provide for adequate decomposition of allergenic proteins. [see description (11)] 8.4.3 evaluation in pediatric subjects 2 to 6 years old open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. subjects were treated with fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. morning pre-stimulation cortisol and post-acth stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. at the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 μg/dl; normal: cortisol > 7μg/dl) but all had normal responses to 0.25 mg of acth stimulation (cortisol > 18 μg/dl). 8.4.4 evaluation in pediatric subjects 3 months to 2 years old an open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the hpa axis by acth stimulation testing following use of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. all subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. morning pre-stimulation and post-acth stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. all subjects had normal responses to 0.125 mg of acth stimulation (cortisol > 18 μg/dl).

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide topical oil, 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. this product contains refined peanut oil nf (see precautions section).

Singapore - engelsk - HSA (Health Sciences Authority)

hyphens pharma pte. ltd. - ciprofloxacin hydrochloride monohydrate 3.49mg eqv ciprofloxacin; fluocinolone acetonide - solution - 3mg - ciprofloxacin hydrochloride monohydrate 3.49mg eqv ciprofloxacin 3mg; fluocinolone acetonide 0.25mg