Ireland - English - HPRA (Health Products Regulatory Authority)

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

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alimera sciences ltd - fluocinolone acetonide - prolonged-release intravitreal implant - 190microgram

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)

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

Israel - English - Ministry of Health

megapharm ltd - fluocinolone acetonide - intravitreal injection - fluocinolone acetonide 190 mcg - fluocinolone acetonide - iluvien is indication for the treatment of vision impairment associated with chronic diabetic macular edema (dme), considered insufficiently responsive to available therapies

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

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

alimera sciences, 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 leve

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

zydus lifesciences limited - cholestyramine (unii: 4b33bgi082) (cholestyramine - unii:4b33bgi082) - cholestyramine 4 g in 5.5 g - 1) cholestyramine for oral suspension usp light powder, is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [ldl] cholesterol) who do not respond adequately to diet. cholestyramine for oral suspension usp light powder may be useful to lower ldl cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. prior to initiating therapy with cholestyramine for oral suspension usp light powder secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess total cholesterol, hdl-c, and triglycerides (tg). for individuals with tg less than 400 mg/dl (< 4.5 mmol/l), ldl-c can be estimated using the following equation:- ldl-c = total cholesterol – [(tg/5) + hdl-c] for tg levels > 400 mg/dl, this equation is less accurate and ldl-c concentrations should be determined by ultracentrifugation. in hypertriglyceridemic patients, ldl-c may be low or normal despite elevated total-c. in such cases cholestyramine for oral suspension usp light powder may not be indicated. serum cholesterol and triglyceride levels should be determined periodically based on ncep guidelines to confirm initial and adequate long-term response. a favorable trend in cholesterol reduction should occur during the first month of cholestyramine for oral suspension usp light powder therapy. the therapy should be continued to sustain cholesterol reduction. if adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine for oral suspension usp light powder or adding other lipid-lowering agents in combination with cholestyramine for oral suspension usp light powder should be considered. since the goal of treatment is to lower ldl-c, the ncep4 recommends that ldl-c levels be used to initiate and assess treatment response. if ldl-c levels are not available then total-c alone may be used to monitor long-term therapy. a lipoprotein analysis (including ldl-c determination) should be carried out once a year. the ncep treatment guidelines are summarized below. * coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). * * other risk factors for coronary heart disease (chd) include: age (males ≥ 45 years; females ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature chd; current cigarette smoking; hypertension; confirmed hdl-c < 35 mg/dl (< 0.91 mmol/l); and diabetes mellitus. subtract one risk factor if hdl-c is ≥ 60 mg/dl (≥ 1.6 mmol/l). cholestyramine for oral suspension usp light powder monotherapy has been demonstrated to retard the rate of progression2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) cholestyramine for oral suspension usp light powder is indicated for the relief of pruritus associated with partial biliary obstruction. cholestyramine for oral suspension usp light powder has been shown to have a variable effect on serum cholesterol in these patients. patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease. cholestyramine for oral suspension usp light powder is contraindicated in patients with complete biliary obstruction where bile is not secreted into the intestine and in those individuals who have shown hypersensitivity to any of its components.

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

zydus lifesciences limited - cholestyramine (unii: 4b33bgi082) (cholestyramine - unii:4b33bgi082) - 1) cholestyramine for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [ldl] cholesterol) who do not respond adequately to diet. cholestyramine for oral suspension may be useful to lower ldl cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. prior to initiating therapy with cholestyramine for oral suspension secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess total cholesterol, hdl-c, and triglycerides (tg). for individuals with tg less than 400 mg/dl (< 4.5 mmol/l), ldl-c can be estimated using the following equation:- ldl-c = total cholesterol – [(tg/5) + hdl-c] for tg levels > 400 mg/dl, this equation is less accurate and ldl-c concentrations should be determined by ultracentrifugation. in hypertriglyceridemic patients, ldl-c may be low or normal despite elevated total-c. in such cases cholestyramine for oral suspension may not be indicated. serum cholesterol and triglyceride levels should be determined periodically based on ncep guidelines to confirm initial and adequate long-term response. a favorable trend in cholesterol reduction should occur during the first month of cholestyramine for oral suspension therapy. the therapy should be continued to sustain cholesterol reduction. if adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine for oral suspension or adding other lipid-lowering agents in combination with cholestyramine for oral suspension should be considered. since the goal of treatment is to lower ldl-c, the ncep4 recommends that ldl-c levels be used to initiate and assess treatment response. if ldl-c levels are not available then total-c alone may be used to monitor long-term therapy. a lipoprotein analysis (including ldl-c determination) should be carried out once a year. the ncep treatment guidelines are summarized below. * coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). ** other risk factors for coronary heart disease (chd) include: age (males ≥ 45 years; females ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature chd; current cigarette smoking; hypertension; confirmed hdl-c < 35 mg/dl (< 0.91 mmol/l); and diabetes mellitus. subtract one risk factor if hdl-c is ≥ 60 mg/dl (≥ 1.6 mmol/l). cholestyramine for oral suspension monotherapy has been demonstrated to retard the rate of progression2,3   and increase the rate of regression3 of coronary atherosclerosis. 2) cholestyramine for oral suspension is indicated for the relief of pruritus associated with partial biliary obstruction. cholestyramine for oral suspension has been shown to have a variable effect on serum cholesterol in these patients. patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease. cholestyramine for oral suspension is contraindicated in patients with complete biliary obstruction where bile is not secreted into the intestine and in those individuals who have shown hypersensitivity to any of its components.