Ireland - English - HPRA (Health Products Regulatory Authority)

alimera sciences limited - fluocinolone acetonide - 190 microgram - fluocinolone acetonide

Ireland - English - HPRA (Health Products Regulatory Authority)

alimera sciences europe limited, - fluocinolone acetonide - intravitreal implant in applicator - 190 microgram(s) - fluocinolone acetonide

United States - English - NLM (National Library of Medicine)

eyepoint pharmaceuticals, inc - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - yutiq ® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. yutiq 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. yutiq is contraindicated in patients with known hypersensitivity to any components of this product. risk summary adequate and well-controlled studies with yutiq have not been conducted in pregnant women to inform drug associated risk. animal reproduction studies have not been conducted with yutiq. it is not known whether yutiq can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. yutiq should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the united states general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary systemically administered corticosteroids are present in human milk and can suppress growth, interfere with endogenous corticosteroid production. clinical or nonclinical lactation studies have not been conducted with yutiq. it is not known whether intravitreal treatment with yutiq could result in sufficient systemic absorption to produce detectable quantities of fluocinolone acetonide in human milk, or affect breastfed infants or milk production. the developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for yutiq and any potential adverse effects on the breastfed child from yutiq. safety and effectiveness of yutiq in pediatric patients have not been established. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

United States - English - NLM (National Library of Medicine)

sincerus florida, llc - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) -

United States - English - NLM (National Library of Medicine)

wilshire pharmaceuticals - ciprofloxacin (unii: 5e8k9i0o4u) (ciprofloxacin - unii:5e8k9i0o4u), fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - ciprofloxacin and fluocinolone acetonide otic solution is indicated for the treatment of acute otitis media with tympanostomy tubes (aomt) in pediatric patients (aged 6 months and older) due to staphylococcus aureus , streptococcus pneumoniae , haemophilus influenzae , moraxella catarrhalis , and pseudomonas aeruginosa . ciprofloxacin and fluocinolone acetonide otic solution is contraindicated in: - patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of ciprofloxacin and fluocinolone acetonide otic solution. - viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections. risk summary ciprofloxacin and fluocinolone acetonide otic solution is negligibly absorbed following otic administration and maternal use is not expected to result in fetal exposure to ciprofloxacin and fluocinolone acetonide [see clinical pharmacology (12.3)]. risk summary ciprofloxaci

United States - English - NLM (National Library of Medicine)

xspire pharma, llc - ciprofloxacin (unii: 5e8k9i0o4u) (ciprofloxacin - unii:5e8k9i0o4u), fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - ciprofloxacin and fluocinolone acetonide otic solution is indicated for the treatment of acute otitis media with tympanostomy tubes (aomt) in pediatric patients (aged 6 months and older) due to staphylococcus aureus , streptococcus pneumoniae , haemophilus influenzae , moraxella catarrhalis , and pseudomonas aeruginosa . ciprofloxacin and fluocinolone acetonide otic solution is contraindicated in: - patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any other components of ciprofloxacin and fluocinolone acetonide otic solution. - viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections. risk summary ciprofloxacin and fluocinolone acetonide otic solution is negligibly absorbed following otic administration and maternal use is not expected to result in fetal exposure to ciprofloxacin and fluocinolone acetonide [see clinical pharmacology (12.3)]. risk summary ciprofloxacin and fluocinolone acetonide otic solution is negligibly absorbed by the mother following otic administration and breastfeeding is not expected to result in exposure of the infant to ciprofloxacin and fluocinolone acetonide [ see clinical pharmacology (12.3) ]. ciprofloxacin and fluocinolone acetonide otic solution has been studied in patients as young as 6 months in adequate and well-controlled clinical trials. no major differences in safety and effectiveness have been observed between adult and pediatric patients [ see indications and usage (1)and dosage and administration (2)]. clinical studies of ciprofloxacin and fluocinolone acetonide otic solution did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. read this instructions for use that comes with ciprofloxacin and fluocinolone acetonide otic solution before you start using it and each time you get a refill. there may be new information. this information does not take the place of talking with your healthcare provider about your medical condition or treatment. important information about ciprofloxacin and fluocinolone acetonide otic solution : - ciprofloxacin and fluocinolone acetonide otic solution is for use in the ear only (otic use) . do not inject ciprofloxacin and fluocinolone acetonide otic solution or use ciprofloxacin and fluocinolone acetonide otic solution in the eye. - use ciprofloxacin and fluocinolone acetonide otic solution exactly as your healthcare provider tells you to use it. how should i use ciprofloxacin and fluocinolone acetonide otic solution? this instructions for use has been approved by the food and drug administration.

Belgium - English - 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

Canada - English - Health Canada

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

Canada - English - Health Canada

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

Canada - English - Health Canada

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