Ferric Subsulfate.....Hemostat - परिणामों की खोज

यूनाइटेड किंगडम - अंग्रेज़ी - MHRA (Medicines & Healthcare Products Regulatory Agency)

ferric derisomaltose 100mg/1ml solution for injection vials

pharmacosmos uk ltd - ferric derisomaltose - solution for injection - 100mg/1ml

यूनाइटेड किंगडम - अंग्रेज़ी - MHRA (Medicines & Healthcare Products Regulatory Agency)

ferric derisomaltose 1g/10ml solution for injection vials

pharmacosmos uk ltd - ferric derisomaltose - solution for injection - 100mg/1ml

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

auryxia- ferric citrate tablet, film coated

akebia therapeutics, inc. - tetraferric tricitrate decahydrate (unii: q91187k011) (ferric cation - unii:91o4lml611) - ferric cation 210 mg - auryxia is indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. auryxia is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease not on dialysis. auryxia is contraindicated in patients with iron overload syndromes (e.g., hemochromatosis) [see warnings and precautions (5.1)] . risk summary there are no available data on auryxia use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. animal reproduction studies have not been conducted using auryxia. skeletal and encephalic malformation was observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7-9. however, oral administration of other ferric or ferrous compounds to gravid cd1-mice and wistar-rats caused no fetal malformation. an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. clinical considerations the effect of auryxia on the absorption of vitamins and other nutrients has not been studied in pregnant women. requirements for vitamins and other nutrients are increased in pregnancy. risk summary there are no human data regarding the effect of auryxia in human milk, the effects on the breastfed child, or the effects on milk production. data from rat studies have shown the transfer of iron into milk by divalent metal transporter-1 (dmt-1) and ferroportin-1 (fpn-1). hence, there is a possibility of infant exposure when auryxia is administered to a nursing woman. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for auryxia and any potential adverse effects on the breastfed child from auryxia or from the underlying maternal condition. the safety and efficacy of auryxia have not been established in pediatric patients. juvenile animal toxicity data in animal studies, greater gastrointestinal toxicity was observed when ferric citrate was administered by gavage as compared to administration with solid food. because auryxia is recommended to be taken with meals and patients under 6 months of age are unlikely to be eating solid food, they may be at greater risk of gastrointestinal toxicity. clinical studies of auryxia included 292 subjects aged 65 years and older (104 subjects aged 75 years and older). overall, the clinical study experience has not identified any obvious differences in responses between the elderly and younger patients in the tolerability or efficacy of auryxia.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

ferrlecit- sodium ferric gluconate complex injection

sanofi-aventis u.s. llc - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. ferrlecit is contraindicated in patients with known hypersensitivity to sodium ferric gluconate or any of its components. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary parenteral iron administration may be associated with hypersensitivity reactions [see warnings and precautions (5.1)] , which may have serious consequences, such as fetal bradycardia (see clinical considerations) . advise pregnant women of the potential risk to the fetus. available data from postmarketing reports with ferrlecit use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. ferrlecit contains benzyl alcohol as a preservative. because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

accrufer- ferric maltol capsule

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.