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.

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

Ireland - English - HPRA (Health Products Regulatory Authority)

ge healthcare limited - ferric (59 fe) citrate injection - solution for injection - 3.7 mbq/ml

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - ferric carboxymaltose 180mg equivalent to iron 50mg - solution for injection - 50 mg/ml - active: ferric carboxymaltose 180mg equivalent to iron 50mg excipient: hydrochloric acid sodium hydroxide water for injection - indicated for the treatment of iron deficiency when oral iron preparations are ineffective, oral preparations cannot be used or there is a clinical need to deliver iron rapidly.

Israel - English - Ministry of Health

uni-pharma kleon tsetis pharmaceutical laboratories ltd. - ferric hydroxide polymaltose complex as - drops - ferric hydroxide polymaltose complex as 50 mg/ml - ferric hydroxide - ferric hydroxide - prevention and treatment of iron deficiency anaemia.

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.

European Union - English - EMA (European Medicines Agency)

shield tx (uk) limited - ferric maltol - anemia, iron-deficiency - antianemic preparations - feraccru is indicated in adults for the treatment of iron deficiency anaemia (ida) in patients with inflammatory bowel disease (ibd).

European Union - English - EMA (European Medicines Agency)

akebia europe limited - ferric citrate coordination complex - hyperphosphatemia; renal dialysis - drugs for treatment of hyperkalaemia and hyperphosphataemia - fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (ckd).

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

international animal health products pty ltd - ammonium ferric citrate - unknown - ammonium ferric citrate mineral-iron active 0.0 - active constituent

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