Australia - English - 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.

Kenya - English - 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

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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

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

troy laboratories pty ltd - glycine; lysine-l hydrochloride; methionine-dl; cobalt gluconate; copper gluconate; ammonium ferric citrate; biotin - vitamin h; choline chloride; inositol; vitamin b12 = cyanocobalamin; vitamin b3 = nicotinamide; pantothenol-d = panthenol-d; vitamin b2 phosphate sodium = riboflavin phosphate sodiu; vitamin b6 hydrochloride = pyridoxine hydrochloride - parenteral liquid/solution/suspension - glycine amino acid-glycine active 20.0 mg/ml; lysine-l hydrochloride amino acid-lysine-l active 20.0 mg/ml; methionine-dl amino acid-methionine-dl active 20.0 mg/ml; cobalt gluconate mineral-cobalt active 0.7 mg/ml; copper gluconate mineral-copper active 0.2 mg/ml; ammonium ferric citrate mineral-iron active 15.0 mg/ml; biotin - vitamin h vitamin-b complex active 10.0 ug/ml; choline chloride vitamin-b complex active 10.0 mg/ml; inositol vitamin-b complex active 10.0 mg/ml; vitamin b12 = cyanocobalamin vitamin-b12 active 150.0 ug/ml; vitamin b3 = nicotinamide vitamin-b3 active 100.0 mg/ml; pantothenol-d = panthenol-d vitamin-b5 active 15.0 mg/ml; vitamin b2 phosphate sodium = riboflavin phosphate sodiu vitamin-b2 active 10.0 mg/ml; vitamin b6 hydrochloride = pyridoxine hydrochloride vitamin-b6 active 10.0 mg/ml - nutrition & metabolism - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - mineral and nutritional additive | acetonaemia | actinobacillosis | amino acid supplement | amino acids | bone fragility | bone growth | calcium supplement | cartilage strength | copper deficiency | egg shell | fatty acid deficiency | fatty liver | glucose | grass tetany | hepatotoxic drugs | hypocalcaemia | hypomagnesaemia | ileitis | iodine deficiencies | lactating | laxative | l-carnitine supplement | liver abscess | liver damage | lysine deficiencies | milk fever | mineral additive | myopathies | myositis syndrome | pangamic acid | phosphorous supplement | rickets | selenium deficiency | shell strength | soft bone disease | vitamin b12 | vitamin d supplement | vitamin e deficiencies | zinc deficiencies

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)

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

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

ceva animal health pty ltd - sodium cacodylate; copper gluconate; ferric chloride - parenteral liquid/solution/suspension - sodium cacodylate mineral-arsenic active 6.4 mg/ml; copper gluconate mineral-copper active 0.19 mg/ml; ferric chloride mineral-iron active 0.68 mg/ml - nutrition & metabolism - dog | horse | bitch | castrate | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at - iron & haemopoietic agent | mineral and nutritional additive | acetonaemia | actinobacillosis | amino acid supplement | amino acids | anaemia | bone fragility | bone growth | calcium supplement | cartilage strength | copper deficiency | egg shell | fatty acid deficiency | fatty liver | glucose | grass tetany | haemopoietic agents | hematinic | hepatotoxic drugs | hypocalcaemia | hypomagnesaemia | ileitis | iodine deficiencies | iron deficiency | lactating | laxative | l-carnitine supplement | liver abscess | liver damage | lysine deficiencies | milk fever | mineral additive | myopathies | myositis syndrome | pangamic acid | phosphorous supplement | rickets | selenium deficiency | shell strength | soft bone disease | vitamin b12 | vitamin d supplement | vitamin e deficiencies | zinc deficiencies

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

ruth consolidated industries pty ltd - manganese (ii) sulphate; caffeine citrate; ammonium ferric citrate; potassium glycerophosphate; sodium glycerophosphate; thiamine as thiamine hydrochloride - oral solution/suspension - manganese (ii) sulphate ungrouped active 2.2 g/l; caffeine citrate alkaloid active 12.0 g/l; ammonium ferric citrate mineral-iron active 23.0 g/l; potassium glycerophosphate mineral-potassium active 24.0 g/l; sodium glycerophosphate mineral-sodium active 21.8 g/l; thiamine as thiamine hydrochloride vitamin-b1 active 0.2 g/l - nutrition & metabolism - dog - greyhound | horse - racehorse | racing greyhound - a restorative | appetite stimulant | aid in correcting inappetance | appetiser (stomachic) | dietary adjunct stimulant | during general convalescence | supportive therapy to infectio