Portugal - portugisisk - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

vifor france - Óxido férrico sacarosado - solução injetável - 100 mg/5 ml - hidróxido de ferro-sacarose 540 mg/ml - iron, parenteral preparations - n/a - duração do tratamento: longa duração

Portugal - portugisisk - INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde)

vifor france - Óxido férrico sacarosado - solução injetável - 100 mg/5 ml - hidróxido de ferro-sacarose 540 mg/ml - iron, parenteral preparations - n/a - duração do tratamento: longa duração

USA - engelsk - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - iron sucrose (unii: fz7nyf5n8l) (ferric cation - unii:91o4lml611) - venofer is indicated for the treatment of iron deficiency anemia (ida) in patients with chronic kidney disease (ckd). known hypersensitivity to venofer. 8.1 pregnancy risk summary published studies on intravenous iron sucrose treatment after the first trimester of pregnancy have not shown adverse maternal or fetal outcomes (see data). available reports of intravenous iron sucrose use in pregnant women during the first trimester are insufficient to assess the risk of major birth defects and miscarriage. there are risks to the mother and fetus associated with untreated ida in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions (see clinical considerations). animal reproduction studies of iron sucrose administered to rats and rabbits during the period of organogenesis at elemental iron doses equivalent to the maximum recommended human dose based on body surface area revealed no evidence of harm to the fetus (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 iron deficiency anemia during pregnancy should be treated. untreated 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. 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 venofer) which may cause fetal bradycardia, especially during the second and third trimester. data human data published data from randomized controlled studies and prospective observational studies on the use of venofer in pregnant women have not reported an association of venofer and adverse developmental outcomes. however, these studies did not include women exposed during the first trimester of pregnancy and were not designed to assess the risk of major birth defects. maternal adverse events reported in these studies are similar to those reported during clinical trials in adult males and non-pregnant females [seeadverse reactions ( 6.1)]. animal data iron sucrose was administered intravenously to rats and rabbits during the period of organogenesis at elemental iron doses up to 13 mg/kg/day (0.25 times or equivalent to the maximum recommended human dose based on body surface area, respectively) and revealed no evidence of harm to the fetus. 8.2 lactation risk summary iron sucrose is present in human milk, and available published reports following exposure to 100-300 mg intravenous iron sucrose have not reported adverse reactions in breastfed infants (see data). there are no data on the effects on milk production. the developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for venofer and any potential adverse effects on the breastfed child from venofer or from the underlying maternal condition. data a published study showed no difference in iron concentration in the colostrum of 10 iron deficient breastfeeding women who were 2 to 3 days postpartum and received a single dose of 100 mg of intravenous iron sucrose compared to 5 breastfeeding women who received no iron. these results may underestimate the amount of iron in breastmilk following the standard dose of venofer. a published report of 78 breastfeeding women who received 300 mg of intravenous iron sucrose over 3 days (infant age not reported) did not report on the safety of iron sucrose in breastfed infants; however adverse reactions in breastfed infants were not reported. clinical considerations monitor breastfed infants for gastrointestinal toxicity (constipation, diarrhea). 8.4 pediatric use safety and effectiveness of venofer for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent ckd have not been established. safety and effectiveness of venofer for iron maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent ckd receiving erythropoietin therapy were studied. venofer at doses of 0.5 mg/kg, 1 mg/kg, and 2 mg/kg was administered. all three doses maintained hemoglobin between 10.5 g/dl and 14.0 g/dl in about 50% of subjects over the 12-week treatment period with stable epo dosing [see clinical studies ( 14.7)]. venofer has not been studied in patients younger than 2 years of age. in a country where venofer is available for use in children, at a single site, five premature infants (weight less than 1,250 g) developed necrotizing enterocolitis and two of the five died during or following a period when they received venofer, several other medications and erythropoietin. necrotizing enterocolitis may be a complication of prematurity in very low birth weight infants. no causal relationship to venofer or any other drugs could be established. 8.5 geriatric use of the 1,051 patients in two post-marketing safety studies of venofer, 40% were 65 years and older. no overall differences in safety or effectiveness were observed between these subjects 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. in general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Slovenien - slovensk - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

lek d.d. - železo - raztopina za injiciranje/infundiranje - železo 20 mg / 1 ml - zdravila z železom za parenteralno uporabo

Island - islandsk - LYFJASTOFNUN (Icelandic Medicines Agency)

vifor france - ferri oxidum saccharated (sykurflétta) - stungulyf, lausn - 20 mg/ml

Estland - estisk - Ravimiamet

vifor france - raud(iii)hüdroksiid-sahharooskompleks - süste-/infusioonilahus - 20mg 1ml 5ml 5tk

Slovakiet - slovakisk - ŠÚKL (Štátny ústav pre kontrolu liečiv)

vifor france, francúzsko - parenterálne lieky s trojmocným železom - 12 - antianaemica

Finland - finsk - Fimea (Suomen lääkevirasto)

vifor france - iron(iii)hydroxide sucrose complex - injektioneste, liuos/infuusiokonsentraatti, liuosta varten - 20 mg/ml - rauta

Tyrkiet - tyrkisk - TİTCK (Türkİye İlaç Ve Tibbİ Cİhaz Kurumu)

abdİ İbrahİm İlaÇ san. ve tİc. a.Ş. - ferrik hidroksit sükroz kompleksi - demir, parenteral hazırlıkları

Letland - lettisk - Zāļu valsts aģentūra

vifor france, france - dzelzs - Šķīdums injekcijām - 20 mg/ml