Новая Зеландия - английский - Medsafe (Medicines Safety Authority)

a. menarini new zealand pty ltd - ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron - solution for injection - 200 mg/2ml - active: ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron excipient: hydrochloric acid sodium hydroxide water for injection - 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

Новая Зеландия - английский - Medsafe (Medicines Safety Authority)

a. menarini new zealand pty ltd - ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron - solution for injection - 500 mg/5ml - active: ferric derisomaltose 417 mg/ml equivalent to 100 mg/ml elemental iron excipient: hydrochloric acid sodium hydroxide water for injection - 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

Кения - английский - Pharmacy and Poisons Board

magnolia care ltd 17, winsford road, london, catsford se66, 4ls - ferric ammonium citrate, folic acid and… - syrup - ferric ammonium citrate usp 200 mg equivalent to… - ferric ammonium citrate

Намибия - английский - Namibia Medicines Regulatory Council

takeda (pty) ltd - ferric carboxymaltose - solution for infusion - each ml contains 50mg iron as ferric carboxymaltose

Великобритания - английский - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Великобритания - английский - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Великобритания - английский - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

Сингапур - английский - HSA (Health Sciences Authority)

vifor pharma asia pacific pte. ltd. - iron eqv iron sucrose - injection - 100 mg/5 ml - iron eqv iron sucrose 100 mg/5 ml

Соединенные Штаты - английский - NLM (National Library of Medicine)

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.

Соединенные Штаты - английский - NLM (National Library of Medicine)

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