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

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.

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

ceva animal health pty ltd - lysine-l hydrochloride; copper sulfate; ammonium ferric citrate; vitamin b2 = riboflavin; glycine; methionine-dl; biotin - vitamin h; choline bitartrate; inositol; vitamin b12 = cyanocobalamin; vitamin b3 = nicotinamide; pantothenol-d = panthenol-d; vitamin b6 hydrochloride = pyridoxine hydrochloride - parenteral liquid/solution/suspension - lysine-l hydrochloride amino acid-lysine-l active 20.0 mg/ml; copper sulfate mineral-copper active 70.0 ug/ml; ammonium ferric citrate mineral-iron active 15.0 mg/ml; vitamin b2 = riboflavin vitamin-b2 active 10.0 mg/ml; glycine amino acid-glycine other 20.0 mg/ml; methionine-dl amino acid-methionine-dl other 20.0 mg/ml; biotin - vitamin h vitamin-b complex other 10.0 ug/ml; choline bitartrate vitamin-b complex other 10.0 mg/ml; inositol vitamin-b complex other 10.0 mg/ml; vitamin b12 = cyanocobalamin vitamin-b12 other 150.0 ug/ml; vitamin b3 = nicotinamide vitamin-b3 other 100.0 mg/ml; pantothenol-d = panthenol-d vitamin-b5 other 15.0 mg/ml; vitamin b6 hydrochloride = pyridoxine hydrochloride vitamin-b6 other 10.0 mg/ml - nutrition & metabolism - cattle | dog | horse | beef | bitch | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | castrate | colt | co - 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

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

vetoquinol australia pty ltd - glycine; lysine hydrochloride; methionine-dl; cobalt gluconate; copper gluconate; ammonium ferric citrate; biotin-d; choline chloride; inositol - anhydrous; vitamin b12 = cyanocobalamin; vitamin b3 = nicotinamide; pantothenol-dl = panthenol-dl; vitamin b2 phosphate sodium = riboflavin phosphate sodiu; vitamin b6 hydrochloride = pyridoxine hydrochloride; benzyl alcohol - parenteral liquid/solution/suspension - glycine amino acid-glycine active 20.0 mg/ml; lysine hydrochloride amino acid-lysine 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-d vitamin-b complex active 10.0 ug/ml; choline chloride vitamin-b complex active 10.0 mg/ml; inositol - anhydrous vitamin-b complex active 10.0 mg/ml; vitamin b12 = cyanocobalamin vitamin-b12 active 0.15 mg/ml; vitamin b3 = nicotinamide vitamin-b3 active 100.0 mg/ml; pantothenol-dl = panthenol-dl 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; benzyl alcohol benzene other 20.0 mg/ml - nutrition & metabolism - horse | colt | donkey | endurance horse | filly | foal | gelding | high performance horses | horses at stud | mare | pacer | pol - not applicable (vet)

New Zealand - English - Ministry for Primary Industries

troy laboratories pty limited - glycine; riboflavin 5'-phosphate sodium; biotin; choline (45% in methanol); racemethionine; dexpanthenol; vitamin b6 (pyridoxine hydrochloride); ferric ammonium citrate; lysine; copper gluconate; vitamin b12; inositol; cobalt gluconate; niacinamide - glycine 20 g/litre; riboflavin 5'-phosphate sodium 10 g/litre; biotin 0.01 g/litre; choline (45% in methanol) 10 g/litre; racemethionine 20 g/litre; dexpanthenol 15 g/litre; vitamin b6 (pyridoxine hydrochloride) 10 g/litre; ferric ammonium citrate 15 g/litre; lysine 20 g/litre; copper gluconate 0.2 g/litre; vitamin b12 0.15 g/litre; inositol 10 g/litre; cobalt gluconate 0.7 g/litre; niacinamide 100 g/litre - parenteral nutrient/electrolyte

Ireland - English - HPRA (Health Products Regulatory Authority)

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

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

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

core pharma limited, tanzania - ferric ammonium , folic acid , pyridoxine , thiamine , nicotinamide - suspension, oral - 200,0.5,(50mcg),1.5,2.33 mg

Philippines - English - FDA (Food And Drug Administration)

agfield international corporation; distributor: agfield international corporation - ferric ammonium citrate, cyanocobalamin (vit. b12), nicotinamide (vit. pp), cobalt gluconate (vet.) - solution for injection (im/sc/oral) - 1.7500 mg/ 0.0250 mg/ 20.0000 mg/ 0.0067 mg

Canada - English - Health Canada

rogar/stb inc. - ferric ammonium citrate; thiamine hydrochloride; riboflavin 5'-phosphate sodium; cobalt gluconate; copper gluconate; nicotinic acid; vitamin b12; dexpanthenol; pyridoxine hydrochloride - liquid - 10mg; 5mg; 1mg; .5mg; .1mg; 25mg; .022mg; 7mg; 2mg - ferric ammonium citrate 10mg; thiamine hydrochloride 5mg; riboflavin 5'-phosphate sodium 1mg; cobalt gluconate .5mg; copper gluconate .1mg; nicotinic acid 25mg; vitamin b12 .022mg; dexpanthenol 7mg; pyridoxine hydrochloride 2mg - vitamin b-complex with minerals - horses