Australie - anglais - Department of Health (Therapeutic Goods Administration)

a menarini australia pty ltd - ferric derisomaltose, quantity: 834 mg (equivalent: iron, qty mg) - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - monofer is indicated for the treatment of iron deficiency in adults, under the following conditions:- when oral iron preparations are ineffective or cannot be used - where there is a clinical need to deliver iron rapidly the diagnosis must be based on laboratory tests.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

seqirus pty ltd - ferric carboxymaltose, quantity: 3.6 g (equivalent: iron, qty 1000 mg) - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; water for injections - ferinject is indicated for the treatment of iron deficiency in adults and adolescents aged 14 years and older when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used ? there is a clinical need to deliver iron rapidly,the diagnosis of iron deficiency must be based on laboratory tests.,ferinject is indicated for the treatment of iron deficiency anaemia in children aged 1 to 13 years when:,? oral iron preparations are ineffective ? oral iron preparations cannot be used,the diagnosis of iron deficiency anaemia must be based on laboratory tests.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

a menarini australia pty ltd - ferric derisomaltose, quantity: 417 mg (equivalent: iron, qty mg) - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - monofer is indicated for the treatment of iron deficiency in adults, under the following conditions: - when oral iron preparations are ineffective or cannot be used; - where there is a clinical need to deliver iron rapidly the diagnosis must be based on laboratory tests.

États-Unis - anglais - NLM (National Library of Medicine)

coopersurgical, inc. - ferric subsulfate (unii: 3qj8ws6v8h) (ferric cation - unii:91o4lml611) - astringyn® is a styptic agent used for achieving local hemostasis. in punch biopsies of the full dermis, the time to achieve hemostasis is typically less than 20 seconds.1 one method for applying ferric subsulfate solution for dermal use consists of the physician placing fingers at the opposite edges of the wound and stretching the skin. the wound is then wiped with gauze, the ferric subsulfate solution applied, and the tension maintained for approximately 15 seconds.2  

États-Unis - anglais - NLM (National Library of Medicine)

pharmacosmos a/s - iron dextran (unii: 95hr524n2m) (ferric cation - unii:91o4lml611) - each ml contains 200 mg iron(iii) as iron(iii) hydroxide dextran complex and phenol as a preservative read the package leaflet before use

États-Unis - anglais - 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.

États-Unis - anglais - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - sodium ferric gluconate complex in sucrose injection 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. sodium ferric gluconate complex in sucrose injection 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 sodium ferric gluconate complex in sucrose injection use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. sodium ferric gluconate comple

États-Unis - anglais - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - sodium ferric gluconate complex (unii: cc9149u2qx) (ferric cation - unii:91o4lml611) - ferric cation 12.5 mg in 1 ml - sodium ferric gluconate complex in sucrose injection 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. sodium ferric gluconate complex in sucrose injection 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 sodium ferric gluconate complex in sucrose injection use in pregnancy are insufficient to assess the risk of major birth defects and miscarriage. sodium ferric gluconate comple

Bangladesh - anglais - DGDA (Directorate General of Drug Administration)

gonoshasthaya pharmaceuticals ltd. - ferric carboxymaltose - injection - 500 mg/10 ml

Australie - anglais - APVMA (Australian Pesticides and Veterinary Medicines Authority)

qpharma pty ltd - ferric subsulphate - unknown - ferric subsulphate mineral-sulfate active 0.0 - active constituent