USA - engelska - NLM (National Library of Medicine)

prasco laboratories - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters 900 mg - omega-3-acid ethyl esters is indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (greater than or equal to 500 mg per dl) hypertriglyceridemia (htg). usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters and should continue this diet during treatment with omega-3-acid ethyl esters. laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy. limitations

USA - engelska - NLM (National Library of Medicine)

american health packaging - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters 1 g - omega-3-acid ethyl esters capsules, usp are indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (greater than or equal to 500 mg/dl) hypertriglyceridemia. usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, usp and should continue this diet during treatment with omega-3-acid ethyl esters capsules, usp. laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of tg-lowering dr

USA - engelska - NLM (National Library of Medicine)

avkare - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters 1 g - omega-3-acid ethyl esters capsules, usp are indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (≥500 mg/dl) hypertriglyceridemia (htg).             usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules, usp and should continue this diet during treatment with omega-3-acid ethyl esters capsules, usp.             laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters. every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.             limitations of use: the effect of omega-3-acid ethyl esters capsules, usp on the risk for pancreatitis has not been determined. the effect of omega-3-acid ethyl esters capsules, usp on cardiovascular mortality and morbidity has not been determined. omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters capsules or any of its components. pregnancy category c: there are no adequate and well-controlled studies in pregnant women. it is unknown whether omega-3-acid ethyl esters capsules can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. omega-3-acid ethyl esters capsules should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. animal data: omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats when given in doses resulting in exposures 7 times the recommended human dose of 4 grams/day based on a body surface area comparison.             in female rats given oral gavage doses of 100, 600, and 2,000 mg/kg/day beginning 2 weeks prior to mating and continuing through gestation and lactation, no adverse effects were observed in the high-dose group (5 times human systemic exposure following an oral dose of 4 grams/day based on body surface area comparison).            in pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg/kg/day from gestation day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).             in pregnant rats given oral gavage doses of 100, 600, and 2,000 mg/kg/day from gestation day 14 through lactation day 21, no adverse effects were seen at 2,000 mg/kg/day (5 times the human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison). however, decreased live births (20% reduction) and decreased survival to postnatal day 4 (40% reduction) were observed in a dose-ranging study using higher doses of 3,000 mg/kg/day (7 times the human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).             in pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg/kg/day from gestation day 7 through 19, no findings were observed in the fetuses in groups given 375 mg/kg/day (2 times human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison). however, at higher doses, evidence of maternal toxicity was observed (4 times human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison). studies with omega-3-acid ethyl esters have demonstrated excretion in human milk. the effect of this excretion on the infant of a nursing mother is unknown; caution should be exercised when omega-3-acid ethyl esters capsules are administered to a nursing mother. an animal study in lactating rats given oral gavage 14 c-ethyl epa demonstrated that drug levels were 6 to 14 times higher in milk than in plasma. safety and effectiveness in pediatric patients have not been established. a limited number of subjects older than 65 years were enrolled in the clinical trials of omega-3-acid ethyl esters capsules. safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years. omega-3-acid ethyl esters capsules do not have any known drug abuse or withdrawal effects.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - omega-3-acid ethyl esters 90, quantity: 1000 mg - capsule, soft - excipient ingredients: purified water; gelatin; glycerol; d-alpha-tocopherol - hypertriglyceridaemia: endogenous hypertriglyceridaemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response. treatment is indicated for the following types of dyslipidaemia (fredrickson classification) only: -type iv & v as monotherapy and with close monitoring of ldl-c levels. - type iib as add-on therapy to statins, when control of triglycerides with statins has been shown to be insufficient. patients with higher baseline levels of triglycerides are more likely to exhibit a better response to omacor. omacor is not indicated in exogenous hypertriglyceridaemia (type 1 hyperchylomicronaemia). there are insufficient data to support the use in patients with secondary endogenous hypertriglyceridaemia including patients with diabetes mellitus.

USA - engelska - NLM (National Library of Medicine)

qpharma inc - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters 900 mg - omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (greater than or equal to 500 mg/dl) hypertriglyceridemia. usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed, if possible, prior to consideration of tg-lowering drug t

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

ibsa farmaceutici italia s.r.l. - eicosapentaenoic acid 460 mg; docosahexaenoic acid 380 mg; tocopherol-d-alfa 4 mg - capsule, soft - 1000 mg - eicosapentaenoic acid 460 mg; docosahexaenoic acid 380 mg; tocopherol-d-alfa 4 mg - omega-3-triglycerides incl. other esters and acids

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - eicosapentaenoic acid; docosahexaenoic acid - oral capsule - 460mg ; 380mg

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

strides pharma uk ltd - eicosapentaenoic acid; docosahexaenoic acid - oral capsule - 460mg ; 380mg

Irland - engelska - HPRA (Health Products Regulatory Authority)

imbat limited - omega-3-acid ethyl esters, eicosapentaenoic acid, docosahexanoic acid - capsules, soft - 1000 milligram - other lipid modifying agents

Irland - engelska - HPRA (Health Products Regulatory Authority)

epax as - omega-3-acid ethyl esters 90 - capsules, soft - 1000 milligram