FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Feraccru in children (17 years and under) has not yet been established.
Croatian: Sigurnost i djelotvornost Feraccrua u djece (u dobi do 17 godina) još nisu utvrđene.
English: Take Feraccru on an empty stomach with half a glass of water (one hour before a meal, or at least 2 hours after a meal).
Croatian: Uzimajte Feraccru natašte s pola čaše vode (jedan sat prije obroka ili najmanje dva sata nakon obroka).
English: Other medicines and Feraccru
Croatian: Drugi lijekovi i Feraccru
English: Ingestion of 20 mg/kg elemental iron is potentially toxic and 200-250 mg/kg is potentially fatal.
Croatian: Unos 20 mg/kg elementarnog željeza potencijalno je toksičan, a 200-250 mg/kg potencijalno smrtonosan.
English: Reporting of suspected adverse reactions:
Croatian: Prijavljivanje sumnji na nuspojave:
English: PHARMACEUTICAL FORM Capsules, hard.
Croatian: OBLIK Kapsule, tvrde.
English: Table 2: Summary of Other Key Efficacy Endpoints (AEGIS 1/2)
Croatian: Tablica 2.: Sažetak drugih ključnih mjera ishoda djelotvornosti (AEGIS 1/2)
English: Do not give Feraccru to children or adolescents 17 years and under as it has not been studied in this age group.
Croatian: Nemojte davati Feraccru djeci i adolescentima u dobi od 17 i manje godina jer ispitivanja za tu dobnu skupinu nisu provedena.
English: Before starting treatment, your doctor will use a blood test to make sure that your anaemia is not severe or caused by anything other than iron deficiency (low iron stores).
Croatian: Prije početka liječenja, Vaš će liječnik obaviti krvne pretrage kako bi bio siguran da Vaša anemija nije težeg stupnja ili uzrokovana nečim drugim osim manjkom željeza (niskom zalihom željeza).
English: Skip the missed dose and take the next dose as normal.
Croatian: Preskočite zaboravljenu dozu i uzmite sljedeću prema uobičajenom rasporedu.
English: However, the conducted reproductive toxicity studies are insufficient to discard any risk in humans.
Croatian: Međutim, provedena ispitivanja u pogledu reproduktivne toksičnosti nedovoljna su da bi se zaključilo kako ne postoje rizici za ljude.
English: Do not store the capsules above 25°C.
Croatian: Kapsule nemojte čuvati na temperaturi iznad 25°C.
English: Iron preparations in excess may cause toxicity especially among children.
Croatian: Prevelike doze pripravaka željeza mogu uzrokovati toksičnost, osobito u djece.
English: Tell your doctor or pharmacist if you are taking any other medicines.
Croatian: Obavijestite liječnika ili ljekarnika ako uzimate neke druge lijekove:
English: The pharmacokinetic profiles of maltol/maltol glucuronide and iron parameters were independent of one another.
Croatian: Farmakokinetički profili maltola / maltol glukuronida i parametri željeza bili su međusobno neovisni.
English: • Some antibiotics, such as ciprofloxacin and tetracycline.
Croatian: • nekih antibiotika kao što su ciprofloksacin i tetraciklin;
English: Adverse reaction frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000) or very rare (<1/10000).
Croatian: Učestalosti nuspojava određene su kako slijedi: vrlo često (≥ 1/10), često (≥ 1/100, < 1/10), manje često (≥ 1/1000, < 1/100), rijetko (≥ 1/10 000, < 1/1000), vrlo rijetko (< 1/10 000).
English: What Feraccru looks like and contents of the pack Feraccru is a red hard capsule containing a reddish-brown powder.
Croatian: Kako Feraccru izgleda i sadržaj pakiranja Feraccru je crvena tvrda kapsula koja sadrži crvenkasto-smeđi prah.
English: The most common side effects (may affect up to 1 in 10 people) of Feraccru are:
Croatian: Najčešće nuspojave (mogu se javiti u manje od 1 na 10 osoba) Feraccrua su:
English: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu FRANCE
Croatian: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu FRANCIJA
English: What Feraccru is and what it is used for
Croatian: Što je Feraccru i za što se koristi
English: • Haemochromatosis and other iron overload syndromes.
Croatian: • Hemokromatoza i drugi sindromi preopterećenja željezom.
English: Feraccru must not be administrated to children (see section 4.2).
Croatian: Feraccru se ne smije davati djeci (vidjeti dio 4.2).
English: If you take more Feraccru than you should
Croatian: Ako uzmete više Feraccrua nego što ste trebali
English: Outer packaging: carton of 1 bottle
Croatian: Vanjsko pakiranje: kutija s 1 bocom
English: • Crospovidone (Type A)
Croatian: • Krospovidon (vrste A)
English: Ferric maltol is not available systemically and is therefore unlikely to pass into the mother's milk.
Croatian: Željezov (III) maltolat nije sistemski dostupan i stoga nije vjerojatno da može doći u majčino mlijeko.
English: Serum samples were assayed for iron parameters.
Croatian: Uzorci seruma ispitivani su na parametre željeza.
English: Abdominal pain (including upper abdomen) Flatulence
Croatian: Bol u abdomenu (uključujući u gornjem dijelu abdomena) Flatulencija
English: Patients were enrolled in one combined randomised, placebo-controlled clinical study (AEGIS 1/2).
Croatian: Bolesnici su bili uključeni u jedno kombinirano randomizirano kliničko ispitivanje kontrolirano placebom (AEGIS 1/2).
English: It is not known if medical products that inhibit UGT enzymes have the potential to increase maltol concentration (see section 4.5).
Croatian: Nije poznato imaju li lijekovi koji inhibiraju enzime UGT potencijal povećati koncentraciju maltola (vidjeti dio 4.5).
English: Pharmacotherapeutic group: Iron trivalent, oral preparation, ATC code: B03AB10.
Croatian: Farmakoterapijska skupina: trovalentno željezo, oralni pripravci, ATK oznaka: B03AB10.
English: TSAT and total serum iron profiles were comparable between Day 1 and Day 8.
Croatian: Profili TSAT-a i ukupnog željeza u serumu bili su usporedivi između 1. i 8. dana.
English: All patients had discontinued from prior oral ferrous product (OFP) treatment: more than 60 % of the subjects stopped taking prior OFP due to adverse events.
Croatian: Svi bolesnici prestali su se liječiti peroralnim pripravcima željeza koje su prethodno upotrebljavali: više od 60 % ispitanika prestalo je uzimati peroralne pripravke željeza koje su prethodno uzimali zbog štetnih događaja.
English: The difference between the change from baseline for Feraccru compared to placebo at week 12 was 2.25 g/dL (p<0.0001).
Croatian: Razlika u promjeni između početne vrijednosti za Feraccru u odnosu na placebo u 12. tjednu bila je 2,25 g/dL (p < 0,0001).
English: MARKETING AUTHORISATION NUMBER EU/1/15/1075/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1075/001
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).
Croatian: Ne smijete uzimati Feraccru ako uzimate dimerkaprol (lijek koji se upotrebljava za uklanjanje toksičnih metala iz krvi), kloramfenikol (koji se upotrebljava za liječenje bakterijskih infekcija) ili metildopu (upotrebljava se za liječenje visokog krvnog tlaka).
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet prvo će periodičko izvješće o neškodljivosti za ovaj lijek dostaviti unutar 6 mjeseci nakon dobivanja odobrenja.
English: Titanium dioxide (E171)
Croatian: Titanijev dioksid (E171)
English: In serious cases there can be recurrence of vomiting and gastrointestinal bleeding, 12 hours after ingestion.
Croatian: U ozbiljnim slučajevima može doći do ponovnog povraćanja i gastrointestinalnog krvarenja, 12 sati nakon uzimanja željeza.
English: Lactose: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Laktoza: ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
English: Blood and urine samples were assayed for maltol and maltol glucuronide.
Croatian: Uzorci krvi i urina ispitivani su na maltol i maltol glukuronid.
English: FRANCE
Croatian: FRANCIJA
English: In mild cases early features improve but in more serious cases there may be evidence of hypoperfusion (cool peripheries and hypotension), metabolic acidosis and systemic toxicity.
Croatian: U blagim slučajevima simptomi se povlače, no u težim slučajevima može doći do hipoperfuzije (hladnih perifernih dijelova i hipotenzije), metaboličke acidoze i sistemske toksičnosti.
English: Too much iron is dangerous in young children and can be life-threatening.
Croatian: Prevelike količine željeza opasne su za malu djecu i mogu biti opasne za život.
English: • Penicillamine (used to bind metals).
Croatian: • penicilamina (koji se upotrebljava za vezanje metala)
English: The use of desferroxamine should be considered: for detailed information see product information provided by the manufacturer.
Croatian: Potrebno je razmotriti mogućnost uporabe deferoksamina: detaljnije informacije o tome potražite u informacijama o lijeku koje je osigurao proizvođač.
English: The treatment should be continued as long as necessary to replenish the body iron stores according to blood tests.
Croatian: Liječenje treba nastaviti koliko god je potrebno da bi se nadomjestile zalihe željeza u tijelu u skladu s krvnim pretragama.
English: There are no data from the use of Feraccru in pregnant women.
Croatian: Nema podataka o uporabi Feraccrua u trudnica.
English: Contents of the pack and other information.
Croatian: Sadržaj pakiranja i druge informacije.
English: These effects were not observable in a second study in dogs receiving up to 300 mg/kg/day.
Croatian: Takvi učinci nisu biti vidljivi u drugom ispitivanju u okviru kojeg su psi primali 300 mg/kg/dan.
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja Feraccrua u jednoj ili više podskupina pedijatrijske populacije s anemijom zbog manjka željeza (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: • Magnesium stearate
Croatian: • Magnezijev stearat
English: The complex dissociates on uptake from the gastro-intestinal tract and the complex itself does not enter the systemic circulation.
Croatian: Kompleks disocira prilikom unosa iz probavnog trakta i sam po sebi ne ulazi u sustavnu cirkulaciju.
English: No effect is expected from an oral iron product.
Croatian: Ne očekuju se nikakvi učinci pripravka željeza za peroralnu primjenu.
English: Iron deficiency was also shown to be corrected by increase in ferritin levels in both studies.
Croatian: Pokazalo se također da je porastom razina feritina manjak željeza ispravljen u oba ispitivanja.
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.
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba) su: žeđ, ukočenost zglobova, bol u prstima ruku/ nogu, glavobolja, akne, crvenilo kože, povraćanje i porast bakterija u tankom crijevu.
English: Intravenous administration of iron salts
Croatian: Intravenska primjena soli željeza
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).
Croatian: Lijekovi koji mogu utjecati na apsorpciju i distribuciju željeza iz Feraccrua Apsorpciju pripravaka željeza za peroralnu primjenu mogu smanjiti soli kalcija i magnezija (na primjer, magnezijev trisilikat).
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet.>
English: • Titanium dioxide (E171)
Croatian: • Titanijev dioksid (E171)
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).
Croatian: Kapsule Feraccru trebaju se uzimati cijele i natašte (s pola čaše vode) jer je apsorpcija željeza smanjena kada se Feraccru uzima s hranom (vidjeti dio 4.5).
English: EXP: Use within 45 days of first opening.
Croatian: Upotrijebiti u roku od 45 dana od prvog otvaranja.
English: Capsule shell:
Croatian: Sadržaj kapsule:
English: The maltol appeared to be rapidly metabolised to maltol glucuronide (Cmax = 4677 + 1613 ng/mL).
Croatian: Pokazalo se da se maltol brzo metabolizira u maltol glukuronid (Cmax = 4677 + 1613 ng/mL).
English: At doses of 500 mg/kg/day testicular degeneration and toxic signs indicative of iron chelation were recorded.
Croatian: Pri dozama od 500 mg/kg/dan zabilježena je pojava testikularne degeneracije i toksičnih znakova koji ukazuju na kelirano željezo.
English: These medicinal products should be given at least 2 hours apart from Feraccru.
Croatian: Ti se lijekovi trebaju uzimati u razmaku od najmanje 2 sata od uzimanja Feraccrua.
English: Of the total maltol ingested, a mean of between 39.8 % and 60.0 % was excreted as maltol glucuronide.
Croatian: Od ukupnog unesenog maltola, izlučeno je prosječno između 39,8 % i 60,0 % maltol glukuronida.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ferric maltol, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za željezov (III) maltolat, znanstveni zaključci CHMP-a su sljedeći:
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.
Croatian: Najčešće zabilježene nuspojave su gastrointestinalni simptomi (bol u abdomenu [8 %], flatulencija [4 %], zatvor [4 %], nelagoda [2 %]/distenzija [2 %] u abdomenu i proljev [3 %]) uglavnom blage do umjerene jačine.
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).
Croatian: Kompleks je osmišljen kako bi osigurao, na kontroliran način, željezo koje se može iskoristiti za unos preko stijenke crijeva i prijenos željeza do proteina za prijenos i pohranu željeza u tijelu (transferina odnosno feritina).
English: • Bisphosphonates (used to treat bone diseases).
Croatian: • bisfosfonata (koji se upotrebljavaju za liječenje koštanih bolesti)
English: Non-clinical studies have shown that maltol is metabolised through UGT1A6 and by sulphation.
Croatian: Neklinička ispitivanja pokazala su da se maltol metabolizira putem UGT1A6 te sulfatacijom.
English: • Some medicines used to treat Parkinson's disease (entacapone, levodopa) and thyroid problems
Croatian: • nekih lijekova za liječenje Parkinsonove bolesti (entakapon, levodopa) i problema sa štitnjačom (levotiroksin);
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.
Croatian: Maltol je ponovno prolazno mjeren u plazmi s poluvijekom od 0,7 sati, s Cmax od 67,3 + 28,3 ng/mL.
English: Rarely, gastric scarring causing stricture or pyloric stenosis (alone or in combination) may lead to partial or complete bowel obstruction 2-5 weeks after ingestion.
Croatian: U rijetkim slučajevima, ožiljci na želucu koji uzrokuju suženje ili piloričnu stenozu (zasebno ili u kombinaciji) mogu dovesti do djelomične ili potpune opstrukcije crijeva 2-5 tjedana nakon uzimanja željeza.
English: HDPE bottles with a child-proof polypropylene push-lock.
Croatian: HDPE boce sa polipropilenskim sigurnosnim zatvaračem za djecu.
English: • Brilliant Blue (E133)
Croatian: • Bojilo Brilliant Blue (E133)
English: If you forget to take your Feraccru
Croatian: Ako ste zaboravili uzeti Feraccru
English: Feraccru is used in adults to treat low iron stores in your body.
Croatian: Feraccru se upotrebljava u odraslih radi liječenja niske razine željeza u tijelu.
English: What you need to know before you take Feraccru
Croatian: Što morate znati prije nego počnete uzimati Feraccru
English: Feraccru is indicated in adults for the treatment of iron deficiency.
Croatian: Feraccru je indiciran u odraslih za liječenje manjka željeza.
English: Symptoms of iron overdose
Croatian: Simptomi predoziranja željezom
English: Early signs and symptoms include nausea, vomiting, abdominal pain and diarrhoea.
Croatian: Rani znakovi i simptomi uključuju mučninu, povraćanje, bol u abdomenu i proljev.
English: SPECIAL STORAGE CONDITIONS Store below 25°C.
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi ispod 25C.
English: Black discolouration of the stool is a well-known ADR of oral iron formulations.
Croatian: Promjena boje stolice u crnu boju poznata je nuspojava peroralnih formulacija željeza.
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.
Croatian: Sigurnost i djelotvornost Feraccrua u liječenju anemije zbog manjka željeza ispitani su na 128 bolesnika (u dobi od 18 do 76 godina; 45 osoba muškog spola i 83 osobe ženskog spola) koji boluju od neaktivne do blago aktivne upalne bolesti crijeva (58 bolesnika s ulceroznim kolitisom [UC] i 70 bolesnika s Crohnovom bolešću [CD]) te početnih vrijednosti Hb koncentracija između 9,5 g/dL i 12 / 13 g/dL u žena / muškaraca.
English: No clinical data on the need to adjust the dosage in patients with impaired hepatic or renal function are available (see section 4.4).
Croatian: Nema dostupnih kliničkih podataka o potrebi prilagodbe doze u bolesnika s oštećenjem funkcije jetre ili bubrega (vidjeti dio 4.4).
English: NAME OF THE MEDICINAL PRODUCT Feraccru 30 mg hard capsules
Croatian: NAZIV LIJEKA Feraccru 30 mg tvrde kapsule
English: Blood tests may show increased levels of proteins that break down chemicals in the blood and of a hormone that stimulates the thyroid gland.
Croatian: Krvne pretrage mogu pokazati povećanu razinu bjelančevina koje razgrađuju kemijske tvari u krvi i hormon koji potiče rad štitnjače.
English: This medicinal product contains lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
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.
Croatian: Maltol izmjeren u plazmi prolazno je pokazao vrijednost AUC0-t između 0,022 i 0,205 h.µg/mL u okviru svih režima doziranja i oba dana ispitivanja.
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;
Croatian: Placebo (N = 64) * srednja vrijednost (SE) Hb na početku: Feraccru 11,0 (1,027) g/dL, placebo 11,1 (0,851) g/dL; ***p<0,0001 u usporedbi s placebo skupinom
English: Administration of iron preparations and tetracyclines should be separated by 2 to 3 hours.
Croatian: Pripravci željeza i tetraciklini trebaju se uzimati u razmaku od 2 ili 3 sata.
English: Brilliant Blue (E133)
Croatian: Bojilo Brilliant Blue (E133)
English: Feraccru should not be used in patients with inflammatory bowel disease (IBD) flare or in IBDpatients with haemoglobin (Hb) <9.5 g/dl.
Croatian: Feraccru se ne smije koristiti u bolesnika s razbuktalom upalnom bolešću crijeva ili u bolesnika s upalnom bolešću crijeva čiji je hemoglobin (Hb) <9,5 g/dL.
English: Table 1: Adverse reactions observed during clinical studies to date.
Croatian: Tablica 1.: Nuspojave zabilježene u kliničkim ispitivanjima do sada KLASIFIKACIJA
English: Serum iron levels measured at about 4 hours after ingestion is the best laboratory measure of severity.
Croatian: Mjerenje koncentracije željeza u serumu otprilike četiri sata nakon unosa željeza najbolji je laboratorijski pokazatelj težine predoziranja.
English: Administration of iron preparations with such compounds should be separated by at least 2 hours.
Croatian: Pripravci željeza i takvi spojevi trebaju se uzimati u razmaku od najmanje 2 sata.
English: Non-clinical studies revealed no special hazard for humans based on repeated dose toxicity and local tolerance studies conducted with ferric maltol.
Croatian: Neklinička ispitivanja ne ukazuju na poseban rizik za ljude na temelju ispitivanja toksičnosti ponovljenih doza i lokalne podnošljivosti provedenih sa željezovim (III) maltolatom.
English: Based on an in vitro study maltol is glucuronised through UGT1A6 (see section 5.2).
Croatian: Na temelju ispitivanja in vitro, glukuronidacija maltola odvija se putem UGT1A6 (vidjeti dio 5.2).
English: Subjects were randomised to receive either 30 mg Feraccru twice daily or a matched placebo control for 12 weeks.
Croatian: Ispitanici su bili randomizirani za primanje ili 30 mg Feraccrua dvaput dnevno ili odgovarajuće placebo kontrole u razdoblju od 12 tjedana.
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).
Croatian: Farmakokinetička svojstva Feraccrua također su ispitana u stanju dinamičke ravnoteže na 15 ispitanika koji su već sudjelovali u prethodno opisanom ispitivanju AEGIS1/2 te u liječenju u fazi otvorenog ispitivanja najmanje 7 dana (Feraccru 30 mg dvaput dnevno).
English: Special care should be taken if other dietary and/or iron salt supplementation are used concurrently.
Croatian: Potreban je poseban oprez ako se istodobno uzimaju drugi dodaci prehrani i/ili nadomjesci u obliku soli željeza.
English: The recommended dose is one capsule twice daily, morning and evening, on an empty stomach (see section 4.5).
Croatian: Preporučuje se uzimati jednu kapsulu dvaput dnevno, jednu ujutro i jednu navečer, natašte (vidjeti dio 4.5).
English: Definitive animal studies are not available for maltol with respect to reproductive toxicity.
Croatian: Konačni rezultati ispitivanja na životinjama za maltol u pogledu reproduktivne toksičnosti nisu dostupni.
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).
Croatian: Pokazalo se da se maltol brzo metabolizira u maltol glukuronid (AUC0-t između 9,83 i 30,9 h.µg/mL u okviru svih režima doziranja).
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.
Croatian: Izloženost maltol glukuronidu povećavala se proporcionalno s dozom u okviru raspona doziranja Feraccrua od 30 do 90 mg dvaput dnevno i nije bilo značajnog nakupljanja ni jednog ni drugog nakon 7 dana liječenja Feraccruom.
English: Poor tissue perfusion may lead to renal failure.
Croatian: Slaba perfuzija tkiva može dovesti do zatajenja bubrega.
English: Iron overdosage is dangerous and can be life-threatening in young children, requiring immediate attention.
Croatian: Predoziranje željezom opasno je i može biti opasno za život malodobne djece te stoga zahtijeva hitno reagiranje.