Yhdysvallat - englanti - NLM (National Library of Medicine)

chartwell rx, llc - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - 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 therapy. limitations of use: the effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. the effect of omega-3-acid ethyl esters capsules 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. risk summary the available data from published case reports and the pharmacovigilance database on the use of omega-3-acid ethyl esters in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, omega-3-acid ethyl esters given orally to female rats prior to mating through lactation did not have adverse effects on reproduction or development when given at doses 5 times the maximum recommended human dose (mrhd) of 4 grams/day, based on a body surface area comparison. omega-3-acid ethyl esters given orally to rats and rabbits during organogenesis was not teratogenic at clinically relevant exposures, based on body surface area comparison (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. 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. data animal data: in female rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) beginning 2 weeks prior to mating through lactation, no adverse effects were observed at 2,000 mg/kg/day (5 times the mrhd based on body surface area [mg/m 2 ]). in a dose-ranging study, female rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) beginning 2 weeks prior to mating through postpartum day 7 had decreased live births (20% reduction) and pup survival to postnatal day 4 (40% reduction) at or greater than 3,000 mg/kg/day in the absence of maternal toxicity at 3,000 mg/kg/day (7 times the mrhd based on body surface area [mg/m 2 ]). in pregnant rats given oral doses of omega-3-acid ethyl esters (1,000, 3,000, or 6,000 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses at a maternally toxic dose (increased food consumption) of 6,000 mg/kg/day (14 times the mrhd based on body surface area [mg/m 2 ]). in pregnant rats given oral doses of omega-3-acid ethyl esters (100, 600, or 2,000 mg/kg/day) from gestation day 14 through lactation day 21, no adverse effects were observed at 2,000 mg/kg/day (5 times the mrhd based on body surface area [mg/m 2 ]). in pregnant rabbits given oral doses of omega-3-acid ethyl esters (375, 750, or 1,500 mg/kg/day) during organogenesis, no adverse effects were observed in fetuses given 375 mg/kg/day (2 times the mrhd based on body surface area [mg/m 2 ]). however, at higher doses, increases in fetal skeletal variations and reduced fetal growth were evident at maternally toxic doses (reduced food consumption and body weight gain) greater than or equal to 750 mg/kg/day (4 times the mrhd), and embryolethality was evident at 1,500 mg/kg/day (7 times the mrhd). risk summary published studies have detected omega-3 fatty acids, including epa and dha, in human milk. lactating women receiving oral omega-3 fatty acids for supplementation have resulted in higher levels of omega-3 fatty acids in human milk. there are no data available on the effects of omega­3 fatty acid ethyl esters on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for omega-3-acid ethyl esters and any potential adverse effects on the breastfed child from omega-3-acid ethyl esters or from the underlying maternal condition. 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. safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years.

Yhdysvallat - englanti - NLM (National Library of Medicine)

strides pharma science limited - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - 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 per 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. 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 therapy

Yhdysvallat - englanti - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - 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 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. 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 therapy. limitation

Yhdysvallat - englanti - NLM (National Library of Medicine)

quality care products, llc - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - 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 per 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 considera

Yhdysvallat - englanti - NLM (National Library of Medicine)

atlantic biologicals corps - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3 fatty acids - unii:71m78end5s) - omega-3-acid ethyl esters 900 mg - lovaza (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (tg) levels in adult patients with severe (≥500 mg/dl) hypertriglyceridemia (htg). ® patients should be placed on an appropriate lipid-lowering diet before receiving lovaza and should continue this diet during treatment with lovaza. usage considerations: laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with lovaza. 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

Yhdysvallat - englanti - NLM (National Library of Medicine)

teva pharmaceuticals, inc. - icosapent ethyl (unii: 6gc8a4payh) (icosapent - unii:aan7qov9ea) - icosapent ethyl capsules are indicated: - as an adjunct to diet to reduce tg levels in adult patients with severe (≥ 500 mg/dl) hypertriglyceridemia. limitations of use: the effect of icosapent ethyl capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. icosapent ethyl capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to icosapent ethyl or any of its components. risk summary the available data from published case reports and the pharmacovigilance database on the use of icosapent ethyl in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies in pregnant rats, non-dose-related imbalances for some minor developmental findings were observed with oral administration of icosapent ethyl during organogenesis at exposures that were equivalent to the clinical exposure at the human dose of 4 g/day, ba

Australia - englanti - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - olive oil, quantity: 50 g; fish oil - rich in omega-3 acids, quantity: 30 g; medium chain triglycerides, quantity: 60 g; soya oil, quantity: 60 g - injection, intravenous infusion - excipient ingredients: glycerol; sodium oleate; dl-alpha-tocopherol; water for injections; egg lecithin; sodium hydroxide - supply of energy and essential fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - olive oil, quantity: 50 g; fish oil - rich in omega-3 acids, quantity: 30 g; medium chain triglycerides, quantity: 60 g; soya oil, quantity: 60 g - injection, intravenous infusion - excipient ingredients: glycerol; sodium oleate; dl-alpha-tocopherol; water for injections; egg lecithin; sodium hydroxide - supply of energy and essential fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - olive oil, quantity: 50 g; fish oil - rich in omega-3 acids, quantity: 30 g; medium chain triglycerides, quantity: 60 g; soya oil, quantity: 60 g - injection, intravenous infusion - excipient ingredients: glycerol; sodium oleate; dl-alpha-tocopherol; water for injections; egg lecithin; sodium hydroxide - supply of energy and essential fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated.

Australia - englanti - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - soya oil, quantity: 20.76 g; olive oil, quantity: 17.3 g; medium chain triglycerides, quantity: 17.3 g; fish oil - rich in omega-3 acids, quantity: 13.84 g - injection, emulsion - excipient ingredients: egg lecithin; glycerol; sodium oleate; dl-alpha-tocopherol; sodium hydroxide; water for injections - finomel is indicated for parenteral nutrition in adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.