FrancophonIA/ELRC3.0 huggingface dataset:
English: In serious cases there can be recurrence of vomiting and gastrointestinal bleeding, 12 hours after ingestion.
Slovenian: V resnih primerih se bruhanje in krvavitev iz prebavil lahko 12 ur po zaužitju ponovita.
English: Supportive and symptomatic measures reflecting best standard medical care should be implemented.
Slovenian: Treba je uvesti najboljše standardno podporno in simptomatsko zdravljenje.
English: Medicinal products that may impact absorption and distribution of iron from Feraccru Absorption of oral iron may be reduced by calcium and magnesium salts (such as magnesium trisilicate).
Slovenian: Zdravila, ki lahko vplivajo na absorpcijo in porazdelitev železa iz zdravila Feraccru Absorpcija peroralnega železa se lahko zmanjša zaradi kalcijevih in magnezijevih soli (kot je magnezijev trisilikat).
English: • Sodium laurilsulfate
Slovenian: • natrijev lavrilsulfat
English: MARKETING AUTHORISATION NUMBER EU/1/15/1075/001
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET EU/1/15/1075/001
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: Priloga IV Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: • Brilliant Blue (E133)
Slovenian: • barvilo briljantno modro (E133)
English: Too much iron is dangerous in young children and can be life-threatening.
Slovenian: Preveč železa je pri majhnih otrocih nevarno, lahko celo smrtno nevarno.
English: • Haemochromatosis and other iron overload syndromes.
Slovenian: • Hematokromatoza in drugi sindromi preobremenitve z železom.
English: Feraccru must not be administrated to children (see section 4.2).
Slovenian: Zdravilo Feraccru se ne sme dajati otrokom (glejte poglavje 4.2).
English: You should not take Feraccru if you are taking dimercaprol (a medicine used to remove toxic metals from the blood), chloramphenicol (used to treat bacterial infections), or methyldopa (used to treat high blood pressure).
Slovenian: Zdravila Feraccru ne smete jemati, če jemljete dimerkaprol (zdravilo, ki se uporablja za odstranjevanje strupenih kovin iz krvi), kloramfenikol (ki se uporablja za zdravljenje bakterijskih okužb) ali metildopo (ki se uporablja za zdravljenje visokega krvnega tlaka).
English: Non-clinical studies have shown that maltol is metabolised through UGT1A6 and by sulphation.
Slovenian: Neklinične študije so pokazale, da se maltol presnavlja zUGT1A6 in s sulfacijo.
English: Driving and using machines Feraccru is unlikely to have any effect on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Feraccru vplivalo na sposobnost vožnje ali upravljanja s stroji.
English: Table 1: Adverse reactions observed during clinical studies to date.
Slovenian: Preglednica 1: Neželeni učinki, opaženi v kliničnih študijah do zdaj.
English: No dose adjustment is needed in elderly patients
Slovenian: Pri starejših bolnikih odmerka ni treba prilagajati.
English: • Lactose monohydrate (see section 2)
Slovenian: • laktoza monohidrat (glejte poglavje 2)
English: What Feraccru is and what it is used for.
Slovenian: Kaj je zdravilo Feraccru in za kaj ga uporabljamo
English: Feraccru is available in bottles, each containing 56 capsules.
Slovenian: Zdravilo Feraccru je na voljo v plastenkah, ki vsebujejo po 56 kapsul.
English: Early signs and symptoms include nausea, vomiting, abdominal pain and diarrhoea.
Slovenian: Zgodnji znaki in simptomi vključujejo slabost, bruhanje, bolečine v trebuhu in drisko.
English: Symptoms of iron overdose
Slovenian: Simptomi prevelikega odmerjanja železa
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom!
English: What Feraccru looks like and contents of the pack Feraccru is a red hard capsule containing a reddish-brown powder.
Slovenian: Izgled zdravila Feraccru in vsebina pakiranja Zdravilo Feraccru je trda rdeča kapsula, ki vsebuje rdečkastorjav prašek.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Feraccru in one or more subsets of the paediatric population in iron deficient anaemia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Feraccru za eno ali več podskupin pediatrične populacije pri zdravljenju anemije zaradi pomanjkanja železa (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The complex is designed to provide, in a controlled way, utilisable iron for uptake across the intestinal wall and transfer to the iron transport and storage proteins in the body (transferrin and ferritin, respectively).
Slovenian: Kompleks je zasnovan tako, da nadzirano sprošča uporabno železo za privzem prek črevesne stene in prenos do beljakovin, ki prenašajo in skladiščijo železo v telesu (transferin oziroma feritin).
English: Feraccru capsules should be taken whole on an empty stomach (with half a glass of water), as the absorption of iron is reduced when Feraccru is taken with food (see section 4.5).
Slovenian: Kapsule zdravila Feraccru je treba vzeti cele na prazen želodec (s pol kozarca vode), saj se absorpcija železa zmanjša, če se zdravilo Feraccru jemlje s hrano (glejte poglavje 4.5).
English: SPECIAL STORAGE CONDITIONS Store below 25°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25C.
English: The maltol appeared to be rapidly metabolised to maltol glucuronide (Cmax = 4677 + 1613 ng/mL).
Slovenian: Videti je bilo, da se je maltol hitro presnovil v maltolovglukuronid (Cmax = 4677 + 1613 ng/ml).
English: At doses of 500 mg/kg/day testicular degeneration and toxic signs indicative of iron chelation were recorded.
Slovenian: Pri odmerkih 500 mg/kg/dan so zabeležili degeneracijo testisov in toksične znake, ki so kazali na kelacijo železa.
English: Shock can result from hypovolaemia or direct cardiotoxicity.
Slovenian: Zaradi hipovolemije ali neposredne kardiotoksičnosti lahko pride do šoka.
English: • Bisphosphonates (used to treat bone diseases).
Slovenian: • bisfosfonati (ki se uporabljajo za zdravljenje bolezni kosti),
English: Uncommon side effects (may affect up to 1 in 100 people) are: thirst, stiff joints, pain in fingers/toes, headache, acne, skin redness, vomiting and increase in bacteria in the small intestine.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) so: žeja, togi sklepi, bolečine v prstih na roki ali na nogi, glavobol, akne, pordela koža, bruhanje in povečanje števila bakterij v tankem črevesju.
English: On the basis of the scientific conclusions for ferric maltol the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing ferric maltol is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za železov maltol odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) železov maltol nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: • Magnesium stearate
Slovenian: • magnezijev stearat
English: Reported severe adverse reactions were abdominal pain [4%], constipation [0.9%] and diarrhoea [0.9%].
Slovenian: Resni neželeni učinki, o katerih so poročali, so bili bolečine v trebuhu [4 %], obstipacija [0,9 %] in driska [0,9 %].
English: Impact of Feraccru on absorption of other medicinal products Oral iron is known to reduce the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine) moxifloxacin, mycophenolate, norfloxacin and ofloxacin.
Slovenian: Učinek zdravila Feraccru na absorpcijo drugih zdravil Znano je, da peroralno železo zmanjšuje absorpcijo penicilamina, bisfosfonatov, ciprofloksacina, entakapona, levodope, levofloksacina, levotiroksina (tiroksina), moksifloksacina, mikofenolata, norfloksacina in ofloksacina.
English: The difference between the change from baseline for Feraccru compared to placebo at week 12 was 2.25 g/dL (p<0.0001).
Slovenian: Razlika v spremembi od izhodišča do 12. tedna med zdravilomFeraccru in placebom je bila 2,25 g/dl (p < 0,0001).
English: The most frequently reported adverse reactions were gastrointestinal symptoms (abdominal pain [8%], flatulence [4%], constipation [4%], abdominal discomfort [2%]/distension [2%] and diarrhoea [3%]) and these were mainly mild to moderate in severity.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so bili prebavni simptomi (bolečine v trebuhu [8 %], flatulenca [4 %], obstipacija [4 %], nelagodje v trebuhu [2 %]/napihnjenost [2 %] in driska [3 %]), ki so bili večinoma blagi do zmerni.
English: • Penicillamine (used to bind metals).
Slovenian: • penicilamin (ki se uporaba za vezavo kovin),
English: The safety and efficacy of Feraccru for the treatment of iron deficiency anaemia was studied in 128 patients (age range 18-76 years; 45 males and 83 females) with inactive to mildly active IBD (58 patients with Ulcerative Colitis [UC] and 70 patients with Crohn's disease [CD]) and baseline Hb concentrations between 9.5 g/dL and 12 / 13 g/dL for females / males.
Slovenian: Varnost in učinkovitost zdravila Feraccru za zdravljenje anemije zaradi pomanjkanja železa so proučevali pri 128 bolnikih (starost od 18 do 76 let, 45 moških in 83 žensk) z neaktivno do blago aktivno KVČB (58 bolnikov z ulcerativnim kolitisom [UK] in 70 bolnikov s Crohnovo boleznijo [CB]), ki so imeli izhodiščne vrednosti Hb med 9,5 g/dLin 12/13 g/dL pri ženskah/moških.
English: • Some medicines used to treat Parkinson's disease (entacapone, levodopa) and thyroid problems
Slovenian: • nekatera zdravila za zdravljenje Parkinsonove bolezni (entakapon, levodopa) in bolezni ščitnice (levotiroksin),
English: Do not use this medicine after the expiry date which is stated on the carton after EXP: The expiry date refers to the last day of that month.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake „EXP“.
English: Maltol was transiently measured in plasma with a AUC0-t between 0.022 and 0.205 h.µg/mL across all dosing regimens and both study days.
Slovenian: Prehodno izmerjena največja koncentracija maltola v plazmi, AUC0-t je bila med 0,022 in 0,205 h.µg/ml pri vseh režimih odmerjanja in na oba dneva študije.
English: The pharmacokinetic properties of Feraccru were also investigated at steady state in 15 subjects who were already participating in the AEGIS1/2 study described above and who had been in the open-label treatment phase for at least 7 days (Feraccru 30 mg twice daily).
Slovenian: Farmakokinetične lastnosti zdravila Feraccru so proučevali tudi v stanju dinamičnega ravnovesja pri 15 preiskovancih, ki so že sodelovali v zgoraj opisani študiji AEGIS1/2 in ki so bili vsaj 7 dni v odprti fazi zdravljenja (zdravilo Feraccru 30 mg dvakrat na dan).
English: Pharmacotherapeutic group: Iron trivalent, oral preparation, ATC code: B03AB10.
Slovenian: Farmakoterapevtska skupina: zdravila s trovalentnim železom za peroralno uporabo, oznaka ATC: B03AB10
English: Maltol was again transiently measured in plasma with a half-life of 0.7 hours, with a Cmax of 67.3 + 28.3 ng/mL.
Slovenian: Ponovno so prehodno izmerili maltol v plazmi z razpolovno dobo 0,7 ure in Cmax 67,3 + 28,3 ng/ml.
English: The maltol appeared to be rapidly metabolised to maltol glucuronide (AUC0-t between 9.83 and 30.9 h.µg/mL across all dosage regimens).
Slovenian: Videti je bilo, da se je maltol hitro presnovil v maltolovglukuronid (AUC0-t med 9,83 in 30,9 h.µg/ml pri vseh režimih odmerjanja).
English: Feraccru (N=64) 1.06 (0.08)*** 1.79 (0.11)*** 66 Placebo (N=64) 0.02 (0.08) * Hb at Baseline mean (SE): Feraccru 11.0 (1.027) g/dL, Placebo 11.1 (0.851) g/dL; ***p<0.0001 compared to placebo group;
Slovenian: Placebo (N = 64) *povprečna vrednost (SE)Hb ob izhodišču: Feraccru 11,0 (1,027) g/dL, placebo 11,1 (0,851) g/dL; ***p<0,0001 v primerjavi s skupino, ki je prejemala placebo
English: Feraccru is indicated in adults for the treatment of iron deficiency.
Slovenian: Zdravilo Feraccru je indicirano pri odraslih za zdravljenje pomanjkanja železa.
English: Concomitant administration of Feraccru and intravenous iron should be avoided as the combination may induce hypotension or even collapse due to the fast release of iron resulting from saturation of transferrin caused by intravenous iron.
Slovenian: Treba se je izogibati sočasnemu dajanju zdravila Feraccru in intravenskega železa, ker ta kombinacija lahko povzroči hipotenzijo ali celo kolaps zaradi hitrega sproščanja železa, ki je posledica nasičenosti transferina zaradi intravenskega železa.
English: Intravenous administration of iron salts
Slovenian: Intravensko dajanje železovih soli
English: Feraccru should not be used in patients with inflammatory bowel disease (IBD) flare or in IBDpatients with haemoglobin (Hb) <9.5 g/dl.
Slovenian: Zdravilo Feraccru se ne sme uporabljati pri izbruhih kronične vnetne črevesne bolezni ali pri bolnikih s KVČB s hemoglobinom (Hb) <9,5 g/dl.
English: Black discolouration of the stool is a well-known ADR of oral iron formulations.
Slovenian: Sprememba barve blata v črno je dobro znan neželeni učinek formulacij peroralnega železa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1075/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/15/1075/001
English: Special care should be taken if other dietary and/or iron salt supplementation are used concurrently.
Slovenian: Ob sočasnem jemanju drugih prehranskih dodatkov in/ali dodatkov z železovo soljo je potrebna posebna pozornost.
English: Food has been shown to inhibit uptake of Feraccru: Feraccru should be taken on an empty stomach (see section 4.2)
Slovenian: Dokazano je, da hrana zavira privzem zdravila Feraccru: zdravilo Feraccru je treba jemati na prazen želodec (glejte poglavje 4.2).
English: What you need to know before you take Feraccru.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Feraccru
English: If you forget to take your Feraccru
Slovenian: Če ste pozabili vzeti zdravilo Feraccru
English: Feraccru has not been studied in patients with impaired renal and/or hepatic function.
Slovenian: Zdravilo Feraccru ni bilo proučeno pri bolnikih z okvarjenim delovanjem ledvic in/ali jeter.
English: Total serum iron concentrations and TSAT values were generally higher with increasing Feraccru doses.
Slovenian: Skupna serumska koncentracija železa in vrednost TSAT se v splošnem povečujeta z večanjem odmerka zdravila Feraccru.
English: Serum samples were assayed for iron parameters.
Slovenian: Parametre železa so merili v vzorcih seruma.
English: No effect is expected from an oral iron product.
Slovenian: Vpliv peroralnih zdravil z železom se ne pričakuje.
English: Maximum total iron serum concentrations were measured 1-2 hours after administration.
Slovenian: Največje skupne serumske koncentracije železa so izmerili 1-2 uri po uporabi.
English: Poor tissue perfusion may lead to renal failure.
Slovenian: Zaradi slabe perfuzije tkiva lahko pride do ledvične odpovedi.
English: NAME OF THE MEDICINAL PRODUCT Feraccru 30 mg hard capsules
Slovenian: IME ZDRAVILA Feraccru 30 mg trde kapsule
English: • Gelatin
Slovenian: • želatina
English: Ferritin continued to rise over long-term treatment with Feraccru (mean 68.9 μg/L [SD 96.24] at 64 weeks, a mean overall improvement of 60.3 μg/L).
Slovenian: Zviševanje ravni feritina se je nadaljevalo med dolgotrajnim zdravljenjem z zdravilom Ferracru (povprečje 68,9 μg/l [SD 96,24] v času 64 tednov, kar je povprečno celokupno izboljšanje za 60,3 μg/l).
English: Red capsule (19 mm long x 7 mm diameter).
Slovenian: FARMACEVTSKA OBLIKA kapsula, trda rdeča kapsula (19 mm dolga x 7 mm v premeru)
English: Evidence of hepatocellular necrosis appears at this stage with jaundice, bleeding, hypoglycaemia, encephalopathy and positive anion gap metabolic acidosis.
Slovenian: V tej fazi se pojavi hepatocelična nekroza, ki se kaže kot zlatenica, krvavitev, hipoglikemija, encefalopatija in metabolna acidoza s pozitivno anionsko vrzeljo.
English: Following completion of the 12-week placebo-controlled phase of the studies, all subjects were switched to Feraccru 30 mg twice daily open-label treatment for a further 52 weeks.
Slovenian: Po zaključku 12-tedenske, s placebom nadzorovane faze študije, so vsi preiskovanci za naslednjih 52 tednov prešli na odprto zdravljenje z zdravilom Feraccru 30 mg dvakrat na dan.
English: • Allura Red AC (E129) (see section 2)
Slovenian: • barvilo alurno rdeče AC (E129) (glejte poglavje 2)
English: Feraccru contains iron in a stable ferric state as a complex with a trimaltol ligand.
Slovenian: Zdravilo Feraccru vsebuje železo v stabilni železovi obliki kot kompleks s trimaltolnimligandom.
English: • Sunset Yellow FCF (E110) (see section 2)
Slovenian: • barvilo sončno rumeno FCF (E110) (glejte poglavje 2)
English: IBD Studies
Slovenian: Študije KVČB
English: Concomitant use of chloramphenicol with iron should be avoided as chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Slovenian: Treba se je izogibati sočasni uporabi kloramfenikola in železa, ker kloramfenikol upočasni plazemski očistek železa, vgradnjo železa v rdeče krvne celice in moti eritropoezo.
English: Each capsule contains 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110).
Slovenian: Ena kapsula vsebuje 91,5 mg laktoze, 0,5 mg barvila alurno rdeče AC (E129) in 0,3 mg barvila sončno rumenoFCF (E110).
English: An increase of ≥1 g/dL change in Hb at Week 12 was achieved in 90 % and 69 % of the ulcerative colitis (N=29) and Crohn's Disease (N=35) subgroups, respectively.
Slovenian: Povečanje vrednosti Hb za ≥ 1 g/dl v 12. tednu je doseglo 90 % bolnikov v podskupini z ulcerativnim kolitisom (N = 29) in 69 % bolnikov v podskupini s Crohnovo boleznijo (N = 35).
English: • Flatulence (wind)
Slovenian: • napenjanje (vetrovi),
English: Feraccru is used in adults to treat low iron stores in your body.
Slovenian: Zdravilo Feraccru se uporablja pri odraslih za zdravljenje zmanjšanih zalog železa v telesu.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: HDPE bottles with a child-proof polypropylene push-lock.
Slovenian: Plastenke iz HDPE s polipropilenskim potisnim zaklepnim zapiralom z otroško zaščito.
English: Based on an in vitro study maltol is glucuronised through UGT1A6 (see section 5.2).
Slovenian: Na podlagi študije in vitro se maltolglukuronizirazUGT1A6 (glejte poglavje 5.2).
English: Northumberland NE61 3YA
Slovenian: MorpethNorthumberland NE61 3YA
English: Concomitant use of iron with dimercaprol should be avoided as the combination of dimercaprol and iron is nephrotoxic.
Slovenian: Treba se je izogibati sočasni uporabi železa in dimerkaprola, ker je kombinacija dimerkaprola in železa nefrotoksična.
English: The PRAC concluded that the product information of products containing ferric maltol should be amended accordingly.
Slovenian: Odbor PRAC je zaključil, da je treba ustrezno popraviti navodila za uporabo zdravil, ki vsebujejo železov maltol.
English: • Colloidal anhydrous silica
Slovenian: • koloidni brezvodni silicijev dioksid
English: Haemodialysis does not remove iron effectively but should be considered on a supportive basis for acute renal failure as this will facilitate removal of the irondesferroxamine complex.
Slovenian: S hemodializo železa ne odstranimo učinkovito, vendar je lahko podporni ukrep pri akutni ledvični odpovedi, ker olajša odstranjevanje kompleksa železa in desferoksamina.
English: Definitive animal studies are not available for maltol with respect to reproductive toxicity.
Slovenian: Za maltol ni na voljo dokončnih študij na živalih o vplivu zdravila na sposobnost razmnoževanja.
English: An increase of ≥2 g/dL change in Hb at Week 12 was achieved in 62 % and 51 % of the ulcerative colitis and Crohn's Disease subgroups, respectively.
Slovenian: Povečanje vrednosti Hb za ≥ 2 g/dl v 12. tednu je doseglo 62 % bolnikov v podskupini z ulcerativnim kolitisom in 51 % bolnikov v podskupini s Crohnovo boleznijo.
English: Do not store the capsules above 25°C.
Slovenian: Kapsule shranjujte pri temperaturi do 25 C.
English: Iron overdosage is dangerous and can be life-threatening in young children, requiring immediate attention.
Slovenian: Preveliko odmerjanje železa je nevarno in pri majhnih otrocih celo smrtno nevarno; takoj je treba poiskati zdravniško pomoč.
English: Mean ferritin (μg/L) levels in subjects taking feraccru improved steadily from baseline (mean 8.6 μg/L [SD 6.77]) to Week 12 (mean 26.0 μg/L [SD 30.57]), a mean overall improvement of 17.4 μg/L.
Slovenian: Povprečne ravni feritina (μg/l) pri bolnikih, ki so jemali zdravilo Ferracru, so se stabilno izboljševale od izhodišča (povprečje 8,6 μg/l [SD 6,77]) do 12. tedna (povprečje 26,0 μg/l [SD 30,57]), kar je povprečno celokupno izboljšanje za 17,4 μg/l.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ferric maltol, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za železov maltol je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Sunset Yellow (E110) and Allura Red (E129): may cause allergic reactions.
Slovenian: Barvili sončno rumeno (E110) in alurno rdeče (E129): lahko povzročita alergijske reakcije.
English: Subjects were randomised to receive either 30 mg Feraccru twice daily or a matched placebo control for 12 weeks.
Slovenian: Preiskovanci so bili za 12 tednov randomizirani na zdravilo Feraccru 30 mg dvakrat na dan ali ustrezno kontrolo s placebom.
English: The pharmacokinetic properties of Feraccru was assessed through measurement of plasma and urine concentrations of maltol and maltol glucuronide, together with serum iron parameters after a single dose and at steady state (after 1 week) in 24 subjects with iron deficiency, randomised to receive 30 mg, 60 mg or 90 mg Feraccru twice daily.
Slovenian: Farmakokinetične lastnosti zdravila Feraccru so ocenjevali z merjenjem koncentracije maltola in maltolovegaglukuronida v plazmi in urinu, skupaj s serumskimi parametri železa, po enkratnem odmerku in v stanju dinamičnega ravnovesja (po enem tednu) pri 24 preiskovancih s pomanjkanjem železa, ki so bili randomizirani na 30 mg, 60 mg ali 90 mg zdravila Feraccru dvakrat na dan. Maltol in maltolovglukuronid so merili v vzorcih krvi in urina.
English: Of the total maltol ingested, a mean of between 39.8 % and 60.0 % was excreted as maltol glucuronide.
Slovenian: Od skupnega zaužitega maltola se je v obliki maltolovegaglukuronida povprečno izločilo med 39,8 % in 60,0 %.
English: However, no carcinogenic effects were recorded in studies conducted in mice and rats receiving up to 400 mg/kg/day maltol.
Slovenian: Vendar pa v študijah na miših in podganah, ki so prejemale do 400 mg maltola/kg/dan, niso zabeležili kancerogenih učinkov.
English: Exposure to maltol glucuronide increased dose proportionally over the Feraccru 30 to 90 mg twice daily dosing range and there was no significant accumulation of either after 7 days treatment with Feraccru.
Slovenian: Izpostavljenost maltolovemuglukuronidu se je povečevala sorazmerno z odmerkom v območju med 30 in 90 mg zdravila Feraccru dvakrat na dan. Ne eden ne drugi se po 7 dneh zdravljenja z zdravilom Feraccru nista kopičila v pomembnejših količinah.
English: Tell your doctor or pharmacist if you are taking any other medicines.
Slovenian: Druga zdravila in zdravilo Feraccru Zdravniku ali farmacevtu morate povedati, če jemljete katera druga zdravila.