Singapore - inglese - HSA (Health Sciences Authority)

apex pharma marketing pte. ltd. - iron (iii) hydroxide sucrose complex eqv iron (iii) - injection - iron (iii) hydroxide sucrose complex eqv iron (iii) 100mg/5ml

Stati Uniti - inglese - NLM (National Library of Medicine)

shield tx (uk) ltd - ferric maltol (unii: ma10qyf1z0) (ferric cation - unii:91o4lml611) - accrufer is indicated for the treatment of iron deficiency in adults. accrufer is contraindicated in patients with a history of: - hypersensitivity to the active substance or to any of the excipients [see description ( 11)] . reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse. - hemochromatosis and other iron overload syndromes [see warnings and precautions ( 5.1)] . use may result in iron overdose [see overdosage ( 10)]. - receiving repeated blood transfusions. use may result in iron overload [see warnings and precautions ( 5.2) and overdosage ( 10)]. risk summary accrufer is not absorbed systemically as an intact complex following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology ( 12.3)] . in animal reproduction studies, oral administration of ferric or ferrous compounds to gravid cd1-mice and wistar-rats during organogenesis at doses 13 to 32 times the recommended human dose resulted in no adverse developmental outcomes. an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. in animal reproduction studies, oral administration of maltol to pregnant crl: cobs-cd (sd) br rats during organogenesis at doses 6 times the recommended human dose resulted in no adverse developmental outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 include increased risk for preterm delivery and low birth weight. data animal data in embryofetal development studies in mice and rats, pregnant animals received oral doses of ferric or ferrous compounds (ferrous sulfate or ferric sodium pyrophosphate) of up to 160 mg/kg/day in mice, or up to 200 mg/kg/day in rats, during the period of organogenesis. administration of ferric or ferrous compounds at doses 13 times (in mice) or 32 times (in rats) the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. in a multigeneration reproductive and developmental study in rats, pregnant animals received oral doses of maltol of 100, 200, and 400 mg/kg/day, during the period of organogenesis. administration of maltol at doses 6 times the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. risk summary there are no data on the presence of accrufer in human milk, the effects on the breastfed child, or the effects on milk production. accrufer is not absorbed systemically as an intact complex by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to accrufer. safety and effectiveness of accrufer have not been established in pediatric patients. of the 295 patients in the randomized trials of accrufer, 39% of patients were aged 65 and older, while 23% were aged 75 and older. no overall differences in safety or effectiveness were observed between these patients and younger patients.

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

ge healthcare limited - ferric (59 fe) citrate injection - solution for injection - 3.7 mbq/ml

Australia - inglese - 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 - inglese - 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)

Israele - inglese - Ministry of Health

uni-pharma kleon tsetis pharmaceutical laboratories ltd. - ferric hydroxide polymaltose complex as - drops - ferric hydroxide polymaltose complex as 50 mg/ml - ferric hydroxide - ferric hydroxide - prevention and treatment of iron deficiency anaemia.

Unione Europea - inglese - EMA (European Medicines Agency)

shield tx (uk) limited - ferric maltol - anemia, iron-deficiency - antianemic preparations - feraccru is indicated in adults for the treatment of iron deficiency anaemia (ida) in patients with inflammatory bowel disease (ibd).

Unione Europea - inglese - EMA (European Medicines Agency)

akebia europe limited - ferric citrate coordination complex - hyperphosphatemia; renal dialysis - drugs for treatment of hyperkalaemia and hyperphosphataemia - fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (ckd).

Filippine - inglese - FDA (Food And Drug Administration)

vifor (international) inc.; importer: zuellig pharma corporation.; distributor: zuellig pharma corporation. - iron (as ferric carboxymaltose) - solution for injection (i.v.) - 50 mg /ml

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

international animal health products pty ltd - ammonium ferric citrate - unknown - ammonium ferric citrate mineral-iron active 0.0 - active constituent