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

ranvet pty. limited - glycerophosphate; iron; ammonium ferric citrate; ferrous sulfate; potassium glycerophosphate; magnesium glycerophosphate; manganese glycerophosphate; sodium glycerophosphate; choline; choline chloride; sorbitol - oral powder, pre-mix - glycerophosphate ungrouped active 21.2 g/l; iron mineral-iron active 11.92 g/l; ammonium ferric citrate mineral-iron active 41.4 g/l; ferrous sulfate mineral-iron active 9.36 g/l; potassium glycerophosphate mineral-potassium active 6.8 g/l; magnesium glycerophosphate mineral-magnesium active 5.43 g/l; manganese glycerophosphate mineral-manganese active 4.6 g/l; sodium glycerophosphate mineral-sodium active 4.37 g/l; choline vitamin-b complex active 0.056 l/l; choline chloride vitamin-b complex active 0.075 l/l; sorbitol carbohydrate other 131.0 g/l - nutrition & metabolism - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - metabolic treatment

Canada - English - Health Canada

american regent, inc - iron (iron dextran complex) - solution - 50mg - iron (iron dextran complex) 50mg - iron preparations

United States - English - 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.

United States - English - 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

United States - English - 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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

vifor france s.a. - iron carboxymaltose 180 mg/ml - eq. iron 50 mg/ml - dispersion for injection/infusion - 50 mg/ml - ferric carboxymaltose 180 mg/ml - iron, parenteral preparations

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

vifor france s.a. - iron carboxymaltose 180 mg/ml - eq. iron 50 mg/ml - dispersion for injection/infusion - 50 mg/ml - ferric carboxymaltose 180 mg/ml - iron, parenteral preparations

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

vifor france s.a. - iron carboxymaltose 180 mg/ml - eq. iron 50 mg/ml - dispersion for injection/infusion - 50 mg/ml - ferric carboxymaltose 180 mg/ml - iron, parenteral preparations

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

zuellig pharma sdn bhd - ferric carboxymaltose -

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

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