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

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)

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)

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).

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

bayer healthcare pharmaceuticals inc. - ferumoxides (unii: g6n3j05w84) (iron - unii:e1uol152h7) - solution - 11.2 mg in 1 ml - feridex i.v. is indicated for i.v. administration as an adjunct to mri (in adult patients) to enhance the t2 weighted images used in the detection and evaluation of lesions of the liver that are associated with an alteration in the res. feridex i.v. is contraindicated in patients with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations.

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

faes farma, s.a. - ferrimanitol ovoalbÚmina - ferrimanitol ovoalbÚmina ....600 mg / (equivalentes a 80 mg de hierro fÉrrico).....

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

takeda uk ltd - ferumoxytol - solution for injection - 30mg/1ml

Canada - English - Health Canada

amag pharmaceuticals inc - iron (ferumoxytol) - solution - 30mg - iron (ferumoxytol) 30mg - iron preparations

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

ecolab inc. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic handwash - for handwashing to decrease bacteria on the skin - recommended for repeated use