Соединенные Штаты - английский - NLM (National Library of Medicine)

bryant ranch prepack - 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 the

Соединенные Штаты - английский - NLM (National Library of Medicine)

bryant ranch prepack - 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/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

Соединенные Штаты - английский - NLM (National Library of Medicine)

puracap laboratories llc dba blu pharmaceuticals - 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 the

Соединенные Штаты - английский - NLM (National Library of Medicine)

bryant ranch prepack - 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/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

Соединенные Штаты - английский - NLM (National Library of Medicine)

bryant ranch prepack - 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

Соединенные Штаты - английский - NLM (National Library of Medicine)

procaps s a - 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/m2]). 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/m2]). 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/m2]). 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/m2]). 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/m2]). 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.

Соединенные Штаты - английский - NLM (National Library of Medicine)

kd pharma usa, 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 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 of use: the effect of omega-3-acid ethyl esters on the risk for pancreatitis has not been determined. the effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined. omega-3-acid ethyl esters are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters 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 can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.omega-3-acid ethyl esters 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 per day based on a body surface area comparison. in female rats given oral gavage doses of 100, 600, and 2,000 mg per kg per 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 per day based on body surface area comparison). in pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg per kg per day from gestation day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). in pregnant rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day from gestation day 14 through lactation day 21, no adverse effects were seen at 2,000 mg per kg per day (5 times the human systemic exposure following an oral dose of 4 grams per 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 per kg per day (7 times the human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). in pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg per kg per day from gestation day 7 through 19, no findings were observed in the fetuses in groups given 375 mg per kg per day (2 times human systemic exposure following an oral dose of 4 grams per 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 per 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 are administered to a nursing mother. an animal study in lactating rats given oral gavage 14c-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. 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 do not have any known drug abuse or withdrawal effects.

Соединенные Штаты - английский - NLM (National Library of Medicine)

golden state medical supply, 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 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 of use: the effect of omega-3-acid ethyl esters on the risk for pancreatitis has not been determined. the effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined. omega-3-acid ethyl esters are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters 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 can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.omega-3-acid ethyl esters 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 per day based on a body surface area comparison. in female rats given oral gavage doses of 100, 600, and 2,000 mg per kg per 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 per day based on body surface area comparison). in pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg per kg per day from gestation day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). in pregnant rats given oral gavage doses of 100, 600, and 2,000 mg per kg per day from gestation day 14 through lactation day 21, no adverse effects were seen at 2,000 mg per kg per day (5 times the human systemic exposure following an oral dose of 4 grams per 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 per kg per day (7 times the human systemic exposure following an oral dose of 4 grams per day based on a body surface area comparison). in pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg per kg per day from gestation day 7 through 19, no findings were observed in the fetuses in groups given 375 mg per kg per day (2 times human systemic exposure following an oral dose of 4 grams per 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 per 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 are administered to a nursing mother. an animal study in lactating rats given oral gavage 14c-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. 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 do not have any known drug abuse or withdrawal effects.

Австралия - английский - Department of Health (Therapeutic Goods Administration)

omegapharm - cefepime -

Австралия - английский - Department of Health (Therapeutic Goods Administration)

omegapharm - piperacillin sodium, quantity: 4170 mg (equivalent: piperacillin, qty 4000 mg); tazobactam sodium, quantity: 536 mg (equivalent: tazobactam, qty 500 mg) - injection, powder for - excipient ingredients: - omegapharm piperacillin and tazobactam is indicated for the treatment of serious bacterial infections caused by susceptible strains of beta-lactamase producing organisms in the following conditions, - lower respiratory tract infections, - urinary tract infections (complicated and uncomplicated), - intra-abdominal infections, - skin and skin structure infections, - bacterial septicaemia, and, - gynaecological infections. children under the age of 12 years. in hospitalised children aged 2 to 12 years, omegapharm piperacillin and tazobactam is indicated for the treatment of serious intra-abdominal infections. it has not been evaluated in this indication for paediatric patients below the age of 2 years. . while omegapharm piperacillin and tazobactam is indicated only for the conditions listed above, it may be used as a single agent in the treatment of mixed infections caused by piperacillin susceptible and beta-lactamase producing, piperacillin resistant organisms. appropriate culture and susceptibility tests sho