USA - engelska - NLM (National Library of Medicine)

royal pharmaceuticals - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - derma-smoothe/fs® is indicated for the topical treatment of atopic dermatitis in adult patients. derma-smoothe/fs® 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 derma-smoothe/fs® needed to cover the affected areas. as with other corticosteroids, derma-smoothe/fs® should be discontinued when control of disease is achieved. contact the physician if no improvement is seen within 2 weeks. derma-smoothe/fs® should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. derma-smoothe/fs® 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 derma-smoothe/fs® . therefore, derma-smoothe/fs® 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 derma-smoothe/fs® 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 derma-smoothe/fs® , 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, derma-smoothe/fs® and histamine/saline controls. subjects were also treated with derma-smoothe/fs® twice daily for 7 days. prick test and patch test results for all 13 patients were negative to derma-smoothe/fs® and the refined peanut oil. one of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of derma-smoothe/fs® . the bulk peanut oil nf, used in derma-smoothe/fs® is heated at 475°f for at least 15 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 derma-smoothe/fs® 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 derma-smoothe/fs® 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 - engelska - NLM (National Library of Medicine)

pharma packaging solutions, llc dba tjoapack llc - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - retisert is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. surgical placement of retisert is contraindicated in active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in active bacterial, mycobacterial or fungal infections of the eye. no adequate animal reproduction studies have been conducted with fluocinolone acetonide. corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. fluocinolone acetonide when administered subcutaneously at a dose of 0.13 mg/kg/day (approximately 10,000 times the daily clinical dose of retisert), during days 6 to 18 of pregnancy in the rabbit, induced abortion at the end of the third and at the beginning of the fourth gestational week. when administered subcutaneously to rats and rabbits during gestation at a maternal toxic dose of 50 mcg/kg/day (approxim

Belgien - engelska - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

alimera sciences europe ltd. - fluocinolone acetonide 0,19 mg - intravitreal implant in applicator - 190 µg - fluocinolone acetonide 0.19 mg - fluocinolone acetonide

Kanada - engelska - Health Canada

bausch & lomb inc - fluocinolone acetonide - implant - 0.59mg - fluocinolone acetonide 0.59mg - corticosteroids

Kanada - engelska - Health Canada

bausch health, canada inc. - fluocinolone acetonide - solution - 0.01% - fluocinolone acetonide 0.01% - anti-inflammatory agents

Kanada - engelska - Health Canada

bausch health, canada inc. - fluocinolone acetonide - ointment - 0.025% - fluocinolone acetonide 0.025% - anti-inflammatory agents

Kanada - engelska - Health Canada

hill dermaceuticals inc - fluocinolone acetonide - solution - 0.01% - fluocinolone acetonide 0.01% - corticosteroids

Kanada - engelska - Health Canada

knight therapeutics inc. - fluocinolone acetonide - implant - 0.19mg - fluocinolone acetonide 0.19mg - corticosteroids

Kanada - engelska - Health Canada

hill dermaceuticals inc - fluocinolone acetonide - emulsion - 0.01% - fluocinolone acetonide 0.01% - anti-inflammatory agents

Israel - engelska - Ministry of Health

cts ltd - ciprofloxacin as hydrochloride; fluocinolone acetonide - ear drops - ciprofloxacin as hydrochloride 3 mg / 1 ml; fluocinolone acetonide 0.25 mg / 1 ml - ciprofloxacin - ciprofloxacin - cetraxal is indicated in adults and in children aged 6 months and older for the following infections:- acute otitis externa (aoe)- acute otitis media in patients with tympanostomy tubes (aomt)caused by ciprofloxacin susceptible microorganisms.consideration should be given to official guidance on the appropriate use of antibacterial agents.