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

fresenius kabi usa, llc - fish oil (unii: xgf7l72m0f) (fish oil - unii:xgf7l72m0f) - omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (pnac). limitations of use: - omegaven is not indicated for the prevention of pnac. it has not been demonstrated that omegaven prevents pnac in parenteral nutrition (pn)-dependent patients [see clinical studies (14)]. - it has not been demonstrated that the clinical outcomes observed in patients treated with omegaven are a result of the omega-6:omega-3 fatty acid ratio of the product [see clinical studies (14)]. use of omegaven is contraindicated in patients with: - known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients [see warnings and precautions (5.2)]. - severe hemorrhagic disorders due to a potential effect on platelet aggregation. - severe disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentrations greater than 1,000 mg/dl) [see warnings and precautions (5.6)]. risk summary there are no av

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

omegapharm - cefepime -

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

omegapharm - cefepime -

Ireland - English - HPRA (Health Products Regulatory Authority)

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

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

physicians total care, inc. - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3-acid ethyl esters - unii:d87ygh4z0q) - omega-3-acid ethyl esters 1 g - 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. usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving lovaza and should continue this diet during treatment with lovaza. laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting lovaza therapy. 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 lovaza on cardiovascular mortality and morbidity

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

rebel distributors corp - omega-3-acid ethyl esters (unii: d87ygh4z0q) (omega-3-acid ethyl esters - unii:d87ygh4z0q) - omega-3-acid ethyl esters 1 g - 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. usage considerations: patients should be placed on an appropriate lipid-lowering diet before receiving lovaza and should continue this diet during treatment with lovaza. laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting lovaza therapy. 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 lovaza on cardiovascular mortality and morbidity in patients

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

tmig, inc. - vitamin d (unii: 9vu1ki44gp) (vitamin d - unii:9vu1ki44gp) - vitamin d 1000 [iu] - 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 consider

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

mylan pharmaceuticals inc. - mycophenolic acid (unii: hu9dx48n0t) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolic acid 180 mg - mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. mycophenolic acid delayed-release tablets are to be used in combination with cyclosporine and corticosteroids. mycophenolic acid delayed-release tablets and mycophenolate mofetil (mmf) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent. mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (mpa), mycophenolate mofetil, or to any of its excipients. reactions like rash, pruritus, hypotension, and chest pain have been observed in clinical trials and post marketing

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

mylan institutional inc. - mycophenolic acid (unii: hu9dx48n0t) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolic acid 180 mg - mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. mycophenolic acid delayed-release tablets are to be used in combination with cyclosporine and corticosteroids. mycophenolic acid delayed-release tablets and mycophenolate mofetil (mmf) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent. mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (mpa), mycophenolate mofetil, or to any of its excipients. reactions like rash, pruritus, hypotension, and chest pain have been observed in clinical trials and post marketing

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

biogen inc. - dimethyl fumarate (unii: fo2303mni2) (monomethyl fumarate - unii:45iub1px8r) - dimethyl fumarate 120 mg - tecfidera is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. tecfidera is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of tecfidera. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.1)]. risk summary available data from the tecfidera pregnancy registry, observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see data ). in animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (dmf) was administered during pregnancy and lactation at clinically relevant doses (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data human data in a prospective observational tecfidera pregnancy registry (2013-2022), the rate of major birth defects among 362 live births and stillbirths from women who were exposed to dimethyl fumarate during pregnancy was 3.6% (95% ci: 1.9-6.1). no specific pattern of major birth defects was identified. important potential study limitations include exposure misclassification, no adjustment for confounders, and lack of an internal comparator cohort. animal data in rats administered dmf orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. this dose also produced evidence of maternal toxicity (reduced body weight). plasma exposure (auc) for monomethyl fumarate (mmf), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (rhd) of 480 mg/day. in rabbits administered dmf orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. the plasma auc for mmf at the no-effect dose is approximately 5 times that in humans at the rhd. oral administration of dmf (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested. neurobehavioral impairment was observed at all doses. a no-effect dose for developmental toxicity was not identified. the lowest dose tested was associated with plasma auc for mmf lower than that in humans at the rhd. risk summary there are no data on the presence of dmf or mmf in human milk. the effects on the breastfed infant and on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tecfidera and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of tecfidera did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.