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

ceva animal health pty ltd - iron as ferric hydroxide sucrose compound - parenteral liquid/solution/suspension - iron as ferric hydroxide sucrose compound mineral-iron-base active 20.0 mg/ml - nutrition & metabolism - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - anaemia | iron deficiency | iron supplement | anaemia

Ireland - English - HPRA (Health Products Regulatory Authority)

rowex ltd - ferric carboxymaltose - solution for injection/infusion - iron, parenteral preparations

Australia - English - Department of Health (Therapeutic Goods Administration)

vifor pharma pty ltd - iron sucrose, quantity: 540 mg/ml (equivalent: iron, qty 20 mg/ml) - injection, concentrated - excipient ingredients: sodium hydroxide; water for injections - venofer is indicated for the treatment of iron deficiency anaemia in patients undergoing chronic haemodialysis and who are receiving supplemental erythropoietin therapy.,the diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. serum ferritin, serum iron, transferrin saturation and hypochromic red cells).

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

pharmacosmos therapeutics inc. - ferric derisomaltose (unii: ahu547pi9h) (ferric derisomaltose - unii:ahu547pi9h) - monoferric is indicated for the treatment of iron deficiency anemia (ida) in adult patients: - who have intolerance to oral iron or have had unsatisfactory response to oral iron - who have non-hemodialysis dependent chronic kidney disease (ndd-ckd) monoferric is contraindicated in patients with a history of serious hypersensitivity to monoferric or any of its components (see warnings and precautions (5.1), description (11)) . reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. risk summary there are no available data on monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. however, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects ( see data) . there are risks to the mother and fetus associated with untreated iron deficiency anemia (ida) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions ( see clinical considerations) . iron complexes have been reported to be teratogenic and embryocidal in non-iron depleted pregnant animals. the findings in animals may be due to iron overload and may not be applicable to patients with iron deficiency. animal reproduction studies of ferric derisomaltose administered to rats and rabbits during the period of organogenesis caused adverse developmental outcomes including structural abnormalities and embryo-fetal mortality at doses approximately 0.09 and 0.4 times the maximum recommended human dose (mrhd) of 1000 mg, respectively, based on body surface area ( see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations 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 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 includes increased risk for preterm delivery and low birth weight. fetal/neonatal adverse reactions severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with parenteral iron products (such as monoferric) which may cause fetal bradycardia, especially during the second and third trimester. data animal data iron complexes have been reported to be teratogenic and embryocidal in non-anemic pregnant animals at single doses above 125 mg iron/kg body weight. the highest recommended dose in human clinical use is 20 mg iron/kg body weight. in a combined fertility and embryo-fetal development study in rats, ferric derisomaltose was administered intravenously to female rats 14 days prior to cohabitation and through gestation day (gd) 17 at doses of 3, 11, and 32 mg fe/kg/day. the doses of 11 and 32 mg fe/kg/day (approximately 0.1 and 0.3 times the mrhd of 1000 mg, based on body surface area (bsa)) resulted in an increase in the incidence of skeletal developmental delays. ferric derisomaltose was administered intravenously to pregnant rabbits during organogenesis, from gd7 to gd20, at doses of 11, 25 and 43 mg fe/kg/day. the dose of 43 mg fe/kg/day (approximately 0.8 times the mrhd of 1000 mg, based on bsa) resulted in increased maternal mortality, abortion, and premature delivery, and increased postimplantation loss. adverse developmental findings at this dose included fetal mortality, reduced fetal weights, and fetal developmental variations and malformations (including domed head, cleft palate, microglossia, hydrocephaly, small brain). fetal malformations and reduced fetal weights were also noted in the 25 mg fe/kg/day group (approximately 0.5 times the mrhd based on bsa). risk summary the available data on the use of monoferric in lactating women demonstrate that iron is present in breast milk. however, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for monoferric in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. clinical considerations monitor breastfed children for gastrointestinal toxicity (constipation, diarrhea). safety and effectiveness have not been established in pediatric patients. of the 3934 patients in clinical studies of monoferric, 29% were 65 years and over, while 13% were 75 years and over. no overall differences in safety or effectiveness were observed between these patients and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Malta - English - Medicines Authority

rowex ltd newtown bantry, co. cork, , ireland - solution for injection/infusion - iron 50 mg/ml - antianemic preparations

Malta - English - Medicines Authority

rowex ltd newtown bantry, co. cork, , ireland - solution for injection/infusion - iron 50 mg/ml - antianemic preparations

Malta - English - Medicines Authority

rowex ltd newtown bantry, co. cork, , ireland - solution for injection/infusion - iron 50 mg/ml - antianemic preparations

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

pharmacosmos a/s - ferric derisomaltose (unii: ahu547pi9h) (ferric derisomaltose - unii:ahu547pi9h) - monoferric is indicated for the treatment of iron deficiency anemia (ida) in adult patients: - who have intolerance to oral iron or have had unsatisfactory response to oral iron - who have non-hemodialysis dependent chronic kidney disease (ndd-ckd) monoferric is contraindicated in patients with a history of serious hypersensitivity to monoferric or any of its components [see warnings and precautions (5.1), description (11)] . reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. risk summary there are no available data on monoferric use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. however, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to ass

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

ausrichter pty ltd - iron-sucrose complex - parenteral liquid/solution/suspension - iron-sucrose complex mineral- iorn base active 20.0 mg - nutrition & metabolism - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - iron deficiency | anaemia

Israel - English - Ministry of Health

cts ltd - ferrous as iron iii hydroxide sucrose complex - solution for injection - ferrous as iron iii hydroxide sucrose complex 20 mg/ml - iron-sorbitol-citric acid complex - iron-sorbitol-citric acid complex - venofer is indicated for the treatment of iron deficiency in the following indications:• where there is a clinical need for a rapid iron supply,• in patients who cannot tolerate oral iron therapy or who are non-compliant,• in active inflammatory bowel disease where oral iron preparations are ineffective,• in chronic kidney disease when oral iron preparations are less effective.the diagnosis of iron deficiency must be based on appropriate laboratory tests (e.g. hb, serum ferritin, tsat, serum iron, etc.)(hb haemoglobin, tsat transferrin saturation)