FrancophonIA/ELRC3.0 huggingface dataset:
English: *Proportion of patients achieving serum phosphorus ≤ 5.5 mg/dl in CKD 5D patients; **Proportion of patients achieving serum phosphorus ≤ 4.0 mg/dl in CKD ND patients NAP: not applicable; SD: standard deviation
Croatian: § Primarni ishod Ispitivanja 304; koprimarni ishod Ispitivanja 204. * Udio bolesnika s KBB 5D koji su postigli razinu fosfora u serumu ≤ 5,5 mg/dl ** Udio bolesnika s KBB ND koji su postigli razinu fosfora u serumu ≤ 4,0 mg/dl NP: nije primjenjivo; SD: standardna devijacija
English: The dose of phosphate binder was titrated as needed to maintain serum phosphorus levels between 3.5 and 5.5 mg/dl, to a maximum of 12 g/day.
Croatian: Doza vezača fosfata bila je titrirana po potrebi, do najviše 12 g dnevno, kako bi se održale razine fosfora u serumu između 3,5 i 5,5 mg/dl.
English: for sevelamer only)
Croatian: Početna razina fosfora u serumu samo za sevelamer)
English: Decreased appetite, hyperkalaemia, hypophosphataemia, increased appetite Dizziness, headache Palpitations, dyspnoea Malignant hypertension
Croatian: povećani apetit omaglica, glavobolja palpitacije, dispneja maligna hipertenzija
English: Talk to your doctor or pharmacist before taking Fexeric if you have: too much iron in your body bowel inflammation
Croatian: Obratite se svom liječniku ili ljekarniku prije nego što uzmete Fexeric ako imate:
English: There are no data regarding the use of ferric citrate coordination complex in pregnant women.
Croatian: Ne postoje podaci o primjeni komplesknog spoja željezovog citrata u trudnica.
English: NAP
Croatian: Nuspojava
English: Increases in ferritin and TSAT above safety thresholds are observed with Fexeric use.
Croatian: Prilikom primjene Fexerica opažena su povišenja feritina i TSAT-a iznad sigurnosnih graničnih vrijednosti.
English: HDPE bottles with child-resistant closure with desiccant.
Croatian: HDPE boce sa sigurnosnim zatvaračem za djecu i sredstvom za sušenje.
English: All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhoea, gastritis, gastritis erosive, and haematemesis).
Croatian: Sve su ozbiljne nuspojave bile gastrointestinalnog karaktera (bol u abdomenu, konstipacija,
English: CKD patients who are not on dialysis require the lower starting dose, 3 g (3 tablets) per day.
Croatian: Bolesnicima s KBB-om koji se ne liječe dijalizom potrebna je niža početna doza od 3 g dnevno (3
English: Package leaflet: Information for the patient Fexeric 1 g film-coated tablets ferric citrate coordination complex This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Fexeric 1 g filmom obložene tablete kompleksni spoj željezovog citrata
English: Data on primary and secondary pharmacodynamics, safety pharmacology and pharmacokinetics of Fexeric were derived from the repeat dose toxicology studies, and did not reveal safety concerns for humans.
Croatian: Podaci o primarnoj i sekundarnoj farmakodinamici, sigurnosnoj farmakologiji i farmakokinetici
English: Pregnancy and women of childbearing potential
Croatian: 4.6 Plodnost, trudnoća i dojenje Trudnoća i žene u reproduktivnoj dobi
English: Bronchitis
Croatian: Nuspojava bronhitis
English: Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of
Croatian: Jedna filmom obložena tableta sadrži 1g kompleksnog spoja željezovog citrata (što odgovara 210 mg
English: During the subsequent 4-week placebo-controlled period, the serum phosphorus levels remained stable in patients receiving Fexeric (mean decrease of 0.24 mg/dl), whereas patients receiving placebo had a mean increase of 1.79 mg/dl (p < 0.0001 for treatment difference).
Croatian: Tijekom narednog 4-tjednog placebom kontroliranog razdoblja razine fosfora u serumu ostale su stabilne u bolesnika koji su primali Fexeric (srednja vrijednost smanjenja od 0,24 mg/dl), dok su bolesnici koji su primali placebo imali srednju vrijednost povećanja od
English: and immunosuppressant (methotrexate) medications showed the potential to interact with Fexeric: any of these or other medicinal products that have the potential to interact with Fexeric, should be taken at least 2 hours before or after Fexeric.
Croatian: U in vitro ispitivanjima neki su antibiotici (doksiciklin, cefdinir), antikonvulzivi (natrijev valproat), antidepresivi (sertralinklorid), bisfosfonati (natrijev alendronat), antiparkinsonici (levodopa) i imunosupresivi (metotreksat) pokazali potencijal za interakcije s Fexericom: bilo koji od tih lijekova ili drugi lijekovi s potencijalom za interakcije s Fexericom moraju se uzimati najmanje 2 sata prije ili
English: Monitoring blood levels of these medicines may also be considered: - ciprofloxacin, doxycycline, cefdinir: medicines to treat bacterial infections - valproic acid: a medicine to treat epilepsy and mental disorders - sertraline: a medicine to treat depression - methotrexate: a medicine to treat rheumatoid arthritis, cancer and the skin disease, psoriasis - alendronate: a medicine to treat decreased bone mass and density - levodopa: a medicine to treat Parkinson's disease - levothyroxine: a medicine to treat thyroid hormone deficiency
Croatian: - alendronat: lijek za liječenje smanjenja koštane mase i gustoće - levodopa: lijek za liječenje Parkinsonove bolesti - levotiroksin: lijek za liječenje manjka hormona štitnjače
English: In CKD 5D patients, the primary evaluation of safety is based on the integrated analysis of data from 4 studies involving 557 CKD 5D patients treated with Fexeric for up to 1 year.
Croatian: U bolesnika s KBB 5D primarna procjena sigurnosti temelji se na integriranoj analizi podataka iz 4
English: Pulmonary oedema, wheezing
Croatian: pruritus, osip
English: The active substance is ferric citrate coordination complex.
Croatian: Djelatna tvar Fexerica je kompleksni spoj željezovog citrata.
English: Active severe gastrointestinal disorders (e.g. gastrointestinal bleeding) Haemochromatosis or laboratory tests indicating possible haemochromatosis Other iron overload (primary or secondary) syndromes
Croatian: Hemokromatoza ili nalazi laboratorijskih pretraga koji ukazuju na moguću hemokromatozu
English: Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of ferric iron).
Croatian: Jedna filmom obložena tableta sadrži 1 g kompleksnog spoja željezovog citrata (što odgovara 210 mg trovalentnog željeza)
English: Fexeric should be temporarily discontinued if serum ferritin exceeds 800 ng/ml.
Croatian: Ako feritin u serumu prelazi 800 ng/ml, primjenu Fexerica treba privremeno prekinuti.
English: No dosage reduction is considered necessary but patients with hepatic impairment should initiate treatment with the lower starting dose, 3 g (3 tablets) per day (see section 5.1).
Croatian: Smatra se da nije nužno smanjenje doze, no bolesnici s oštećenjem jetre trebaju započeti liječenje s nižom početnom dozom od
English: See the end of section 4
Croatian: Za postupak prijavljivanja nuspojava, pogledajte dio 4.
English: abdominal pain/discomfort, nausea, vomiting, haemorrhoids, haematochezia, mucous stools, dyspepsia, flatulence, dry mouth
Croatian: Poremećaji metabolizma i prehrane hipofosfatemija proljev, konstipacija, promjena boje fecesa bol /nelagoda u abdomenu, mučnina, povraćanje, hemoroidi, hematohezija, sluzave stolice, dispepsija, flatulencija, suha usta
English: Adverse Reaction
Croatian: inkontinencija
English: In the pivotal non-dialysis study 204, a total of 148 CKD ND patients with hyperphosphatemia and iron deficiency anaemia received treatment with study drug; there were 141 patients in the intent-totreat population (Fexeric: 72 patients; Placebo: 69 patients).
Croatian: populacija koju se namjeravalo liječiti (ITT, engl. intent-to-treat) obuhvaćala je 141 bolesnika (Fexeric: 72 bolesnika; placebo: 69 bolesnika).
English: The following side effects have been reported with Fexeric in dialysis patients: Very common side effects (may affect more than 1 in 10 people):
Croatian: Vrlo česte nuspojave (mogu se javiti kod više od 1 na 10 osoba):
English: As a secondary endpoint in dialysis patients, and a co-primary endpoint in non-dialysis patients, the ability of Fexeric to increase iron stores was also evaluated.
Croatian: Također je ocijenjena sposobnost Fexerica da poveća zalihe željeza kao sekundarni ishod u bolesnika liječenih dijalizom i kao koprimarni ishod u bolesnika koji nisu liječeni dijalizom.
English: - if you are allergic to ferric citrate coordination complex or any of the other ingredients of this medicine (listed in section 6) - if you have low levels of phosphorus in your blood - if you have a severe stomach or bowel disease such as stomach or bowel bleeding
Croatian: - ako imate tešku želučanu ili crijevnu bolest kao što je želučano ili crijevno krvarenje;
English: Hypophosphataemia
Croatian: Klinička djelotvornost
English: This medicine contains ferric citrate coordination complex as the active substance.
Croatian: Djelatna tvar u ovom lijeku jest kompleksni spoj željezovog citrata.
English: Also contains sunset yellow FCF (E110), Allura Red AC (E129), see the package leaflet for futher
Croatian: Također sadrži boje Sunset Yellow FCF (E110) i Allura Red AC (E129).
English: Uncommon:
Croatian: SN: NN:
English: They are supplied in one pack size of
Croatian: Dostavljaju se u pakiranju jedne veličine koje sadrži 200 tableta po boci.
English: Do not store above 25°C Keep the bottle tightly closed in order to protect from moisture.
Croatian: Ne čuvati na temperaturi iznad 25°C.
English: The most commonly reported adverse reactions in dialysis-dependent chronic kidney disease (CKD 5D) patients during treatment were discoloured faeces and diarrhoea occurring in 18% and 13% of patients, respectively.
Croatian: (KBB 5D) bile su promjena boje fecesa koja se javila u 18 %, i proljev koji se javio u 13 % bolesnika.
English: Clinical consequences are unknown.
Croatian: Kliničke posljedice nisu poznate.
English: Target organ
Croatian: Ciljni organ
English: Other body areas
Croatian: Druga područja tijela
English: <Product name> is approved for use in children above two years of age.
Croatian: <Naziv lijeka> je odobren za primjenu u djece starije od dvije godine.
English: This includes retention in the brain and in other tissues and organs.
Croatian: To uključuje zadržavanje u mozgu i drugim tkivima i organima.
English: Brain and spine
Croatian: Mozak i kralješnica
English: Because of the lack of information on repeated administration, <Product name> injections should not be repeated unless the interval between injections is at least 7 days.
Croatian: Zbog nedostatka informacija o ponovljenoj primjeni, injekcije <Naziv lijeka>se ne smiju ponavljati osim ako je interval između injekcija najmanje 7 dana.
English: • part for healthcare professionals: Post-contrast imaging acquisition:
Croatian: • dio za zdravstvene radnike: Dobivanje prikaza nakon kontrasta:
English: o Accumulation in the body <Product name> works because it contains a metal called gadolinium.
Croatian: o Nakupljanje u tijelu <Naziv lijeka> djeluje zato što sadrži metal koji se naziva gadolinij.
English: • Section 2: What you need to know before you are given <product name>
Croatian: • Dio 2: Što morate znati prije nego primite <naziv lijeka>
English: Intravenous gadobenic acid (restriction of the indication - all references to other indications should be removed across the Product Information)
Croatian: Gadobenatna kiselina za intravensku primjenu (ograničenje indikacije - iz informacija o lijeku moraju se ukloniti sve reference na druge indikacije)
English: • Section 1 What <Product name> is and what it is used for
Croatian: • Dio 1 Što je <Naziv lijeka> i za što se koristi
English: The amount in millilitre you will be injected depends on how much you weigh in kilogram of body weight.
Croatian: Količina koja će Vam biti ubrizgana u mililitrima ovisi o Vašoj tjelesnoj težini u kilogramima.
English: Dynamic imaging:
Croatian: Dinamičko oslikavanje:
English: Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Croatian: Bolesnici koji se podvrgavaju transplantaciji jetre su pod pojačanim rizikom jer je incidencija akutnog zatajenja bubrega visoka u ovoj skupini.
English: • Assessment of myocardial perfusion
Croatian: •procjena perfuzije miokarda
English: Studies have shown that small amounts of gadolinium can remain in the body, including the brain.
Croatian: Ispitivanja su pokazala da male količine gadolinija mogu ostati u tijelu, uključujući i mozak.
English: • Specific applications in the heart include measurement of myocardial perfusion under pharmacological stress conditions and viability diagnostics ("delayed enhancement").
Croatian: • Specifične primjene u srcu uključuju mjerenje perfuzije miokarda pod farmakološkim stresnim uvjetima i dijagnostici funkcije („odgođeno poboljšanje“).
English: Immediately following bolus injection.
Croatian: Neposredno nakon bolus injekcije.
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR< 30ml/min /1.73 m2).
Croatian: Prijavljeni su slučajevi nefrogene sistemske fibroze (NSF) povezane s primjenom nekih kontrastnih sredstava koja sadrže gadolinij u bolesnika s akutnim ili kroničnim teškim oštećenjem bubrega (GFR <30 ml/min/1,73 m2).
English: This has not been seen following the small amounts given with injections into the joint.
Croatian: To nije bilo opaženo nakon primjene malih količina koje se daju injekcijom u zglob.
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Croatian: Izmjene i dopune odgovarajućih dijelova informacija o lijeku Postojeće informacije o lijeku treba prilagoditi (umetnuti, zamijeniti ili izbrisati tekst, kako je prikladno) kako bi odgovarale dogovorenom tekstu koji je naveden niže.
English: Signal intensity increases and non-clinical data show that gadolinium is released from linear GdCAs.
Croatian: Pojačanje intenziteta signala i neklinički podaci pokazuju da se gadolinij oslobađa iz linearnih gadolinijskih kontrastnih sredstava.
English: The dose should be calculated based on the patient's body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section.
Croatian: Dozu treba izračunati na temelju tjelesne težine bolesnika, te ona ne smije biti viša od preporučene doze po kilogramu tjelesne težine navedene u ovom dijelu.
English: Brain and Spine up to 60 minutes after the administration.
Croatian: Mozak i kralješnica Do 60 minuta nakon primjene.
English: It helps your doctor to identify any abnormalities of your liver brain/spine, arteries or other parts of your body.
Croatian: Pomaže liječniku u otkrivanju bilo kakvih promjena na jetri mozgu/kralješnici, arterijama ili drugim dijelovima Vašeg tijela.
English: These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Croatian: Ove izmjene i dopune odgovarajućih dijelova informacija o lijeku rezultat su arbitražnog postupka.
English: The lowest dose that provides sufficient enhancement for diagnostic purposes should be used.
Croatian: Potrebno je primijeniti najnižu dozu koja osigurava dovoljno pojačanje prikaza za dijagnostičke svrhe.
English: • Section 3 How to use <Product name>
Croatian: • Dio 3: Kako primjenjivati <Naziv lijeka>
English: between 40 and 120 minutes following the injection, depending on the individual imaging needs.
Croatian: između 40 i 120 minuta nakon injekcije, ovisno o potrebama snimanja u pojedinom slučaju.
English: <Product name> is injected into a vein, usually in your arm just before the MRI scan.
Croatian: <Naziv lijeka> se ubrizgava u venu, obično ruke, neposredno prije pregleda MR-om.
English: Retention of gadolinium in the brain has not been identified for intra-articular administration.
Croatian: Zadržavanje gadolinija u mozgu nije zabilježeno kod intraartikularne primjene.
English: Liver, kidneys, urinary tract , adrenal glands
Croatian: Jetra, bubrezi, urinarni trakt, adrenalne žlijezde
English: • MRI of the brain and spine in adults and children above the age of 2 years, where it improves the detection of lesions and provides diagnostic information additional to that obtained with unenhanced MRI (see section 5.1).
Croatian: • MR mozga i kralježnice u odraslih i djece u dobi iznad 2 godine, gdje pojačava detekciju lezija i osigurava dodatne dijagnostičke informacije uz one dobivene s MR-om bez pojačanja signala (vidjeti dio 5.1).
English: A T1-weighted, gradient-echo sequence with a time resolution of 2 minutes or less should be acquired before contrast injection and repeated several times over a period of 5 to 8 min after a rapid intravenous contrast bolus injection.
Croatian: T1-mjerena, dinamička akvizicija s vremenskom razlučivosti od 2 minute ili manje prije injekcije kontrasta te ponovljena nekoliko puta tijekom perioda od 5-8 minuta nakon brze intravenske bolus injekcije kontrasta.
English: Delayed imaging: between 40 and 120 minutes following the injection, depending on the individual imaging needs.
Croatian: Odgođeno oslikavanje: između 40 i 120 minuta nakon injekcije, ovisno o potrebama snimanja u pojedinom slučaju.
English: As there is a possibility that NSF may occur with <Product name>, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI.
Croatian: Budući da postoji mogućnost da se NSF može javiti s <Naziv lijeka>, mora ga se izbjegavati u bolesnika s teškim oštećenjem bubrega te u bolesnika koji su u perioperativnom razdoblju transplantacije jetre, osim ako su dijagnostičke informacije neophodne i ne mogu se dobiti s MR-om bez kontrastnog pojačanja.
English: T1-weighted sequences to be acquired as either dynamic or static delayed imaging.
Croatian: T1-mjerena sekvenca, kao akvizicija dinamičkog ili statičkog odgođenog oslikavanja.
English: The possible diagnostic advantages of using <active substance name (INN)> in patients who will require repeated scans should be weighed against the potential for deposition of gadolinium in the brain and other tissues.
Croatian: Potrebno je procijeniti moguće dijagnostičke prednosti primjene <djelatna tvar (INN)> u bolesnika u kojih će biti potrebna ponovljena snimanja u odnosu na potencijal gadolinija da se taloži u mozgu i drugim tkivima.
English: Studies have shown that after exposure to GdCAs given intravenously at significantly higher doses than intra-articular products gadolinium is retained in the body.
Croatian: Ispitivanja su pokazala da se nakon izloženosti gadolinijskom kontrastnom sredstvu primijenjenom intravenski u značajno višim dozama nego kod intraartikularnih pripravaka, gadolinij zadržava u tijelu.
English: • Magnetic Resonance Angiography (MRA) for the assessment of stenoses, occlusions and collaterals in adults and children (above the age of 2 years).
Croatian: • MR angiografija (MRA) za procjenu stenoze, okluzije i kolaterala u odraslih i djece (u dobi iznad 2 godine).
English: Post-contrast imaging acquisition: Liver
Croatian: Dobivanje prikaza nakon kontrasta: Jetra
English: immediately after the administration, with scan delay calculated on the basis of test bolus or automatic bolus detection technique.
Croatian: Neposredno nakon primjene, s odgođenim prikazom izračunatim na temelju testnog bolusa ili tehnike automatske detekcije bolusa.
English: • Assessment of cardiac masses or myocardial viability
Croatian: • procjena mase srca ili funkcije miokarda
English: Delayed imaging:
Croatian: Odgođeno oslikavanje:
English: If an automatic contrast detection pulse sequence is not used for bolus timing, then a test bolus injection <2 mL of the agent should be used to calculate the appropriate scan delay.
Croatian: Ako se ne primijeni automatska kontrastna detekcija pulsne sekvencije za vremensko usklađivanje bolusa, tada je potrebno primijeniti testnu bolus injekciju sa sredstvom < 2 ml, kako bi se izračunalo odgovarajuće odgađanje prikaza.
English: • MR imaging of the whole body in adults and children (above the age of 2 years) including head and neck region, thoracic space (including the heart and female breast), abdomen (pancreas and liver), abdomen (gastrointestinal tract), retroperitoneal space (kidney, adrenal glands), pelvis (prostate, bladder and uterus) and musculoskeletal system where it facilitates identification of abnormal structures or lesions and helps in differentiating normal from pathological tissues (see sections 4.2 and
Croatian: • MR oslikavanje cijelog tijela u odraslih i djece (u dobi iznad 2 godine), uključujući područje glave i vrata, prostor toraksa (uključujući srce i dojke u žena) abdomena (gušteraču i jetru), abdomena (gastrointestinalnog trakta), retroperitoneuma (bubrezi, adrenalne žlijezde), pelvisa (prostata, mokraćni mjehur i maternica) i mišićno-koštanog sustava gdje poboljšava identifikaciju abnormalnih struktura ili lezija i pomaže u razlikovanju normalnog od patoloških tkiva (vidjeti dijelove 4.2 i 5.1).
English: <Product name> is a special dye (or contrast agent) which contains the rare earth metal gadolinium and improves images of the liver brain/spine, arteries and other body areas during MRI scans.
Croatian: <Naziv lijeka> je specijalna boja (ili kontrastno sredstvo) koja sadrži rijetki zemljani metal, gadolinij, i pojačava prikaze jetre mozga/kralješnice, arterija i drugih područja tijela tijekom pregleda magnetskom rezonancijom.
English: <Product name> is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) indicated for: of the liver in adults and children (above the age of 2 years)
Croatian: <Naziv lijeka> je paramagnetsko kontrastno sredstvo za primjenu u dijagnostičkom snimanju magnetskom rezonancijom (MR) indicirano za: jetre u odraslih i djece (starije od 2 godine).
English: Section 4.1 Therapeutic indications <Product name> is indicated for the detection of focal liver lesions and provides information on the character of lesions in T1-weighted magnetic resonance imaging (MRI).
Croatian: Dio 4.1 Terapijske indikacije <Naziv lijeka> je indiciran za otkrivanje fokalnih lezija u jetri i pruža informacije o prirodi lezija pri snimanju T1-mjerene snimke magnetskom rezonancijom (MR).
English: MRI of brain/spine: 0.2 ml per kilogram of body weight MRI of arteries: 0.2 ml per kilogram of body weight MRI of the liver, the kidney, urinary tract or adrenal glands: 0.1 ml per kilogram of body weight
Croatian: MR oslikavanje mozga/kralješnice: 0,2 ml po kilogramu tjelesne težine MRI oslikavanje arterija: 0,2 ml po kilogramu tjelesne težine MR oslikavanje jetre, bubrega, urinarnog trakta ili adrenalnih žlijezdi: 0,1 ml po kilogramu tjelesne težine
English: No side effects have been seen due to gadolinium remaining in the brain.
Croatian: Nisu opažene nuspojave zbog gadolinija koji zaostaje u mozgu.
English: Amendments to relevant sections of the product information
Croatian: Izmjene i dopune odgovarajućih dijelova informacija o lijeku
English: MRI of the breast, heart or other body areas: 0.2 ml per kilogram of body weight
Croatian: MR oslikavanje dojki, srca ili drugih područja tijela: 0,2 ml po kilogramu tjelesne težine
English: If use of <Product name> cannot be avoided, the dose should not exceed 0.1 mmol/kg body weight when used for MR of the brain and spine, MR-angiography breast MRI or whole body MRI and should not exceed 0.05 mmol/kg body weight when used for MR of the liver, kidneys, urinary tract or adrenal glands.
Croatian: Ako se ne može izbjeći primjena <Naziv lijeka>, doza ne smije prekoračiti 0,1 mmol/kg tjelesne težine kada se koristi za MR mozga i kralješnice, angiografiju, MR oslikavanje dojki ili MR oslikavanje cijelog tijela i ne smije preći 0,05 mmol/kg tjelesne težine kada se koristi za MR jetre, bubrega, urinarnog trakta ili adrenalnih žlijezdi.