Ferumoxytol - search results

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

ferumoxytol injection

sandoz inc - ferumoxytol non-stoichiometric magnetite (unii: clh5ft6412) (ferumoxytol non-stoichiometric magnetite - unii:clh5ft6412) - ferumoxytol is indicated for the treatment of iron deficiency anemia (ida) in adult patients: ferumoxytol is contraindicated in patients with: risk summary limited available data with ferumoxytol use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and fetus associated with untreated iron deficiency anemia (ida) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see clinical considerations ). in animal studies, administration of ferumoxytol to pregnant rabbits during organogenesis caused adverse developmental outcomes including fetal malformations and decreased fetal weights at maternally toxic doses of 6 times the estimated human daily dose. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the e

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

feraheme- ferumoxytol injection

amag pharmaceuticals, inc. - ferumoxytol non-stoichiometric magnetite (unii: clh5ft6412) (ferumoxytol non-stoichiometric magnetite - unii:clh5ft6412) - ferumoxytol non-stoichiometric magnetite 510 mg in 17 ml - feraheme is indicated for the treatment of iron deficiency anemia (ida) in adult patients: feraheme is contraindicated in patients with: risk summary limited available data with ferumoxytol use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. there are risks to the mother and fetus associated with untreated iron deficiency anemia (ida) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see clinical considerations ). in animal studies, administration of ferumoxytol to pregnant rabbits during organogenesis caused adverse developmental outcomes including fetal malformations and decreased fetal weights at maternally toxic doses of 6 times the estimated human daily dose. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estim

European Union - English - EMA (European Medicines Agency)

rienso

takeda pharma a/s - ferumoxytol - anemia; kidney failure, chronic - other antianemic preparations - rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (ckd).the diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).