Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

abio marketing sdn bhd - iron (iii)- hydroxide sucrose complex -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

zuellig pharma sdn bhd - iron (iii)- hydroxide sucrose complex -

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

help s.a. pedini - iron (iii)-hydroxide sucrose complex - solution for i/v injection or concentrate for solution for infusion - 20mg/ml

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

shield tx (uk) ltd - ferric maltol (unii: ma10qyf1z0) (ferric cation - unii:91o4lml611) - accrufer is indicated for the treatment of iron deficiency in adults. accrufer is contraindicated in patients with a history of: - hypersensitivity to the active substance or to any of the excipients [see description ( 11)] . reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse. - hemochromatosis and other iron overload syndromes [see warnings and precautions ( 5.1)] . use may result in iron overdose [see overdosage ( 10)]. - receiving repeated blood transfusions. use may result in iron overload [see warnings and precautions ( 5.2) and overdosage ( 10)]. risk summary accrufer is not absorbed systemically as an intact complex following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology ( 12.3)] . in animal reproduction studies, oral administration of ferric or ferrous compounds to gravid cd1-mice and wistar-rats during organogenesis at doses 13 to 32 times the recommended human dose resulted in no adverse developmental outcomes. an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. in animal reproduction studies, oral administration of maltol to pregnant crl: cobs-cd (sd) br rats during organogenesis at doses 6 times the recommended human dose resulted in no adverse developmental outcomes. the estimated 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. clinical considerations disease-associated maternal and/or embryo/fetal risk untreated iron deficiency anemia (ida) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. adverse pregnancy outcomes associated with ida include increased risk for preterm delivery and low birth weight. data animal data in embryofetal development studies in mice and rats, pregnant animals received oral doses of ferric or ferrous compounds (ferrous sulfate or ferric sodium pyrophosphate) of up to 160 mg/kg/day in mice, or up to 200 mg/kg/day in rats, during the period of organogenesis. administration of ferric or ferrous compounds at doses 13 times (in mice) or 32 times (in rats) the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. in a multigeneration reproductive and developmental study in rats, pregnant animals received oral doses of maltol of 100, 200, and 400 mg/kg/day, during the period of organogenesis. administration of maltol at doses 6 times the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. risk summary there are no data on the presence of accrufer in human milk, the effects on the breastfed child, or the effects on milk production. accrufer is not absorbed systemically as an intact complex by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to accrufer. safety and effectiveness of accrufer have not been established in pediatric patients. of the 295 patients in the randomized trials of accrufer, 39% of patients were aged 65 and older, while 23% were aged 75 and older. no overall differences in safety or effectiveness were observed between these patients and younger patients.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - sucroferric oxyhydroxide -

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة أدوية الحكمة - hikma pharmaceuticals - iron (as ferric carboxymaltose) 500 mg/10ml - (as ferric carboxymaltose) 500 mg/10ml

Singapore - English - HSA (Health Sciences Authority)

apex pharma marketing pte. ltd. - iron (iii) hydroxide sucrose complex eqv iron (iii) - injection - iron (iii) hydroxide sucrose complex eqv iron (iii) 100mg/5ml

Israel - English - Ministry of Health

cts ltd - ferric carboxymaltose - solution for injection / infusion - ferric carboxymaltose 1800 mg/vial - ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. the diagnosis must be based on laboratory tests.

Israel - English - Ministry of Health

cts ltd - ferric carboxymaltose - solution for injection / infusion - ferric carboxymaltose 1800 mg/vial - ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. the diagnosis must be based on laboratory tests. 28/10/2014 בקשה לשינוי משטר מינונים

Israel - English - Ministry of Health

cts ltd - ferric carboxymaltose - solution for injection / infusion - ferric carboxymaltose 1800 mg/vial - ferinject is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. the diagnosis must be based on laboratory tests.