FrancophonIA/ELRC3.0 huggingface dataset:
English: • Drop the tablet(s) into a glass of water, or apple or orange juice (100 to 200 ml).
Croatian: • Ubacite tabletu(e) u čašu s vodom ili sokom od jabuke ili naranče (100 do 200 ml).
English: (signs of severe skin reaction, see also section 4 “Possible side effects”).
Croatian: (znakovi teške alergijske reakcije, vidjeti također dio 4. „Moguće nuspojave”).
English: Acid-base balance should be monitored as clinically indicated in these populations.
Croatian: U toj populaciji se acido-bazna ravnoteža mora pratiti kako je klinički indicirano.
English: • Sleep disorder
Croatian: • Poremećaj spavanja
English: EXJADE has minor influence on the ability to drive and use machines.
Croatian: EXJADE malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Prior to launch of EXJADE in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka EXJADE u promet u svakoj državi članici, nositelj odobrenja mora se dogovoriti oko sadržaja i formata edukacijskog programa s nacionalnim nadležnim tijelom, uključujući komunikacijske medije, načine distribucije i bilo koje druge aspekte programa.
English: Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC03
Croatian: Farmakoterapijska skupina: kelatori željeza, ATK oznaka: V03AC03
English: • The maximum recommended daily dose for EXJADE film-coated tablets is:
Croatian: • Najviša preporučena dnevna doza EXJADE filmom obloženih tableta je:
English: The corresponding doses for the different formulations are shown in the table below.
Croatian: Odgovarajuće doze za različite formulacije lijeka prikazane su u tablici u nastavku.
English: • On two occasions prior to initiation of treatment
Croatian: • u dva navrata prije početka liječenja
English: There were no clinically relevant changes in deferasirox pharmacokinetics when EXJADE granules were administered with food.
Croatian: Nije bilo klinički relevantnih promjena u farmakokinetici deferasiroksa kada su se EXJADE granule primjenjivale uz hranu.
English: If there is a persistent and progressive increase in serum transaminase levels that cannot be attributed to other causes, EXJADE should be interrupted.
Croatian: Uoči li se ustrajno i progresivno povećanje razina serumskih transaminaza koje se ne može pripisati drugim uzrocima, primjena lijeka EXJADE mora se prekinuti.
English: EXJADE is not recommended - if you are at an advanced stage of myelodysplastic syndrome (MDS; decreased production of blood cells by the bone marrow) or have advanced cancer.
Croatian: EXJADE se ne preporučuje - ako ste u uznapredovalom stadiju mijelodisplastičnog sindroma (MDS; bolest smanjenog stvaranja krvnih stanica u koštanoj srži) ili ako imate uznapredovali stadij raka.
English: Do not dissolve the tablets in fizzy drinks or milk.
Croatian: Tablete nemojte otapati u gaziranim napitcima ili mlijeku.
English: • If you vomit blood and/or have black stools,
Croatian: • Ako povraćate krv i/ili imate crne stolice,
English: EXJADE may decrease the efficacy of hormonal contraceptives (see section 4.5).
Croatian: EXJADE može smanjiti djelotvornost hormonskih kontraceptiva (vidjeti dio 4.5).
English: EXJADE can be used by people aged 65 years and over at the same dose as for other adults.
Croatian: Osobe u dobi od 65 godina i više mogu uzimati EXJADE u istim dozama kao i druge odrasle osobe.
English: In patients with a short life expectancy (e.g. high-risk myelodysplastic syndromes), especially when co-morbidities could increase the risk of adverse events, the benefit of EXJADE might be limited and may be inferior to risks.
Croatian: U bolesnika s kratkim očekivanim trajanjem života (npr. mijelodisplastični sindromi visokog rizika), osobito ako druge istodobne bolesti mogu povećati rizik od štetnih događaja, korist primjene lijeka EXJADE može biti ograničena i može biti manja od rizika.
English: • Physician educational material
Croatian: • Edukacijski materijal za liječnike
English: Your doctor will calculate the dose you need and tell you how many sachets to take each day.
Croatian: Liječnik će izračunati kolika Vam doza treba i reći koliko vrećica trebate uzimati svakoga dana.
English: White to almost white granules
Croatian: Granule u vrećici (granule) Bijele do gotovo bijele granule
English: In patients treated with doses >30 mg/kg/day - When target is reached
Croatian: U bolesnika liječenih dozama >30 mg/kg/dan - Kada se postigne cilj
English: After the suspension has been swallowed, any residue must be resuspended in a small volume of water or juice and swallowed.
Croatian: Ako nakon gutanja suspenzije u čaši zaostane talog mora ga se ponovno suspendirati u malom volumenu vode ili soka i progutati.
English: After a high-fat meal, only AUC was mildly increased (by 18%).
Croatian: Nakon punomasnog obroka, samo je AUC bio blago povišen (za 18%).
English: What you need to know before you take EXJADE
Croatian: Što morate znati prije nego počnete uzimati EXJADE
English: These reactions are dose-dependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is continued.
Croatian: Te reakcije su ovisne o dozi, uglavnom su blage do umjerene, općenito prolazne i većinom nestaju i uz nastavak liječenja.
English: • The need to monitor serum ferritin monthly
Croatian: • potreba mjesečnog praćenja serumskog feritina
English: These were dose-dependent.
Croatian: Vrijednosti su bile ovisne o dozi.
English: Taking EXJADE at the same time each day will also help you remember when to take your medicine.
Croatian: Uzimanje lijeka EXJADE svakoga dana u isto vrijeme pomoći će Vam da se sjetite kada uzeti lijek.
English: Taking EXJADE at the same time each day will also help you remember when to take your tablets.
Croatian: Uzimanje lijeka EXJADE svakoga dana u isto vrijeme pomoći će Vam da se sjetite kada uzeti tablete.
English: *LIC is the preferred method of iron overload determination.
Croatian: *LIC je preferirana metoda određivanja preopterećenja željezom.
English: EXJADE is not recommended during pregnancy unless clearly necessary.
Croatian: EXJADE se ne preporučuje tijekom trudnoće, osim ako to nije posve neophodno.
English: > age appropriate ULN**
Croatian: > GGN-a prikladnog za godine**
English: Do not swallow whole or chew.
Croatian: Ne gutati cijele niti žvakati.
English: Deferasirox was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/- heterozygous mice in a 6-month study.
Croatian: Deferasiroks nije bio karcinogen u štakora u 2-godišnjem ispitivanju ni u transgeničnih p53+/- heterozigotnih miševa u 6-mjesečnom ispitivanju.
English: - if you vomit blood and/or have black stools.
Croatian: - ako povraćate krv i/ili imate crne stolice.
English: Deferasirox has been investigated in 411 adult (age 16 years) and 292 paediatric patients (aged 2 to <16 years) with chronic iron overload due to blood transfusions.
Croatian: Deferasiroks je ispitivan u 411 odraslih (dob ≥16 godina) i 292 pedijatrijska (u dobi od 2 do <16 godina) bolesnika s kroničnim preopterećenjem željezom zbog transfuzija krvi.
English: Although there was no significant effect (increase in the extent of absorption AUC by 18-19%; no change in Cmax) of a high-fat meal on deferasirox pharmacokinetics, it is recommended that deferasirox granules be taken either with or without a light meal (see section
Croatian: Iako nije bilo značajnog učinka (povećanja razmjera AUC-a apsorpcije za 18-19%; bez promjene u Cmax) obroka s visokim sadržajem masnoća na farmakokinetiku deferasiroksa, preporučuje se uzimati granule deferasiroksa uz lagani obrok ili bez obroka (vidjeti dio 5.2).
English: The Cmax and AUC0-24h of deferasirox increase approximately linearly with dose under steady-state conditions.
Croatian: Cmax i AUC0-24h deferasiroksa povećavaju se otprilike linearno s porastom doze u uvjetima stanja dinamičke ravnoteže.
English: • Additional risk minimisation measures The MAH must inform the European Medicines Agency and the CHMP of the results of the surveillance programme in each Member State.
Croatian: Nositelj odobrenja mora obavijestiti Europsku agenciju za lijekove i CHMP o rezultatima programa nadzora u svakoj državi članici.
English: • Monthly thereafter o The need to reduce by 10 mg/kg the dose if serum creatinine rises:
Croatian: • poslije toga jednom mjesečno o potreba smanjenja doze za 10 mg/kg ako dođe do rasta serumskog kreatinina:
English: Sachets of polyethylene terephthalate (PET)/Aluminium/polyethylene (PE) foil.
Croatian: Vrećice od polietilentereftalata (PET)/aluminijske/polietilenske (PE) folije.
English: When the granules were administered with apple sauce or yogurt, a food effect was absent.
Croatian: Kada su granule bile primijenjene uz jabučnu kašu ili jogurt, nije bilo učinka hrane na apsorpciju.
English: • Take EXJADE film-coated tablets either on an empty stomach or with a light meal.
Croatian: • EXJADE filmom obložene tablete uzimajte ili na prazan želudac ili uz lagani obrok.
English: Doses (in mg/kg) must be calculated and rounded to the nearest whole sachet size.
Croatian: Doze (u mg/kg) se moraju izračunati i zaokružiti do najbliže doze cijele vrećice.
English: A placebo-controlled randomised study was performed in 225 patients with MDS (Low/Int-1 risk) and transfusional iron overload.
Croatian: Placebom kontrolirano randomizirano ispitivanje provedeno je na 225 bolesnika s MDS-om (niski/srednji-1 rizik) i preopterećenjem željezom izazvano transfuzijama.
English: The dispersible tablets are dispersed by stirring in a glass of water or orange or apple juice (100 to 200 ml) until a fine suspension is obtained.
Croatian: Tablete za oralnu suspenziju se suspendiraju miješanjem u čaši vode ili narančinog ili jabučnog soka (100 do 200 ml) do dobivanja fine suspenzije.
English: EXJADE contains an active substance called deferasirox.
Croatian: EXJADE sadrži djelatnu tvar koja se zove deferasiroks.
English: Serum creatinine, creatinine clearance (estimated with the Cockcroft-Gault or MDRD formula in adults and with the Schwartz formula in children) and/or plasma cystatin C levels should be monitored prior to therapy, weekly in the first month after initiation or modification of therapy with EXJADE (including switch of formulation), and monthly thereafter.
Croatian: Serumski kreatinin, klirens kreatinina (u odraslih procijenjen Cockcroft-Gaultovom ili MDRD formulom, a u djece Schwartzovom formulom) i/ili razine cistatina C u plazmi trebaju se pratiti prije terapije, svaki tjedan tijekom prvog mjeseca nakon početka ili modifikacije terapije lijekom EXJADE (uključujući promjenu formulacije lijeka), a zatim jednom mjesečno.
English: Physicians and patients should remain alert for signs and symptoms of gastrointestinal ulceration and haemorrhage during EXJADE therapy and promptly initiate additional evaluation and treatment if a serious gastrointestinal adverse reaction is suspected.
Croatian: Liječnici i bolesnici moraju stalno paziti na znakove i simptome koji upućuju na gastrointestinalne ulceracije i krvarenja tijekom terapije lijekom EXJADE te odmah započeti dodatne pretrage i liječenje u slučaju sumnje na ozbiljnu gastrointestinalnu nuspojavu.
English: • Disturbance in urine test (protein in the urine) If any of these affects you severely, tell your doctor.
Croatian: • Poremećaj testova mokraće (bjelančevine u mokraći) Ako se bilo koja od ovih nuspojava kod Vas javi u teškom obliku, obavijestite svog liječnika.
English: The results of this study suggest that there is a positive impact of deferasirox on event-free survival (EFS, a composite endpoint including non-fatal cardiac or liver events) and serum ferritin levels.
Croatian: Rezultati ove studije ukazuju da postoji pozitivan utjecaj deferasiroksa na preživljenje bez događaja (engl. event-free survival, EFS, mjera kompozitnog ishoda koja uključuje nefatalne srčane ili jetrene događaje) i razine serumskog feritina.
English: The Cmax was increased by 34% (90% CI: 27.9% - 40.3%); however a clinical exposure/response analysis revealed no evidence of clinically relevant effects of such an increase.
Croatian: Cmax je bio povišen za 34% (90% CI: 27,9% - 40,3%); međutim analiza kliničke izloženosti/odgovora nije otkrila nikakve dokaze klinički relevantnih učinaka takvog povišenja.
English: Women of childbearing potential are recommended to use additional or alternative non-hormonal methods of contraception when using EXJADE.
Croatian: Ženama u reproduktivnoj dobi se preporučuje korištenje dodatne ili zamjenske nehormonske metode kontracepcije tijekom primjene lijeka EXJADE.
English: In addition to monthly serum ferritin assessments, LIC should be monitored every three months when serum ferritin is ≤800 µg/l.
Croatian: Osim mjesečnog određivanja serumskog feritina, LIC je potrebno pratiti svaka 3 mjeseca kad je serumski feritin ≤800 µg/l.
English: Patients with estimated creatinine clearance <60 ml/min.
Croatian: Bolesnici s procijenjenim klirensom kreatinina <60 ml/min.
English: Dose reduction or interruption may be also considered if abnormalities occur in levels of markers of renal tubular function and/or as clinically indicated:
Croatian: Smanjenje doze ili prekid liječenja može se također razmatrati ako se pojave abnormalnosti u razinama markera bubrežne tubularne funkcije i/ili prema kliničkoj indikaciji:
English: The average Cmax of deferasirox in subjects with mild or moderate hepatic impairment was increased by 22%.
Croatian: Prosječni Cmax deferasiroksa u ispitanika s blagim ili umjerenim oštećenjem jetre je povećan za 22%.
English: • Every week during the first month of initiation of treatment or after therapy modification
Croatian: • svakog tjedna tijekom prvog mjeseca nakon početka liječenja ili nakon prilagodbe terapije
English: • Brief overview of methods of measuring creatinine clearance
Croatian: • kratak pregled metoda mjerenja klirensa kreatinina
English: The film-coated tablets are ovaloid and biconvex.
Croatian: Filmom obložene tablete su ovalne i bikonveksne.
English: • If you experience frequent abdominal pain, particularly after eating or taking EXJADE,
Croatian: • Ako imate česte bolove u trbuhu, posebno nakon jela ili uzimanja lijeka EXJADE,
English: The principal analysis of the pivotal comparative study in 586 patients suffering from beta-thalassaemia and transfusional iron overload did not demonstrate non-inferiority of deferasirox dispersible tablets to deferoxamine in the analysis of the total patient population.
Croatian: Glavna analiza rezultata ključnog komparativnog kliničkog ispitivanja na 586 bolesnika s betatalasemijom i transfuzijskim preopterećenjem željezom nije dokazala neinferiornost deferasiroks tableta za oralnu suspenziju u odnosu na deferoksamin kada je u analizu bila uključena cijela populacija bolesnika.
English: • A decrease in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (anaemia aggravated), in the number of white blood cells (neutropenia) or in the number of all kinds of blood cells (pancytopenia)
Croatian: • Smanjenje broja stanica koje su uključene u zgrušavanje krvi (trombocitopenija), broja crvenih krvnih stanica (pogoršanje anemije), broja bijelih krvnih stanica (neutropenija) ili svih vrsta krvnih stanica (pancitopenija)
English: o The need to interrupt treatment after a dose reduction if serum creatinine rises:
Croatian: o potreba da se prekine liječenje nakon smanjenja doze u slučaju porasta serumskog kreatinina:
English: • When serum creatinine is elevated and if another abnormality has been detected (e.g. proteinuria, signs of Fanconi syndrome).
Croatian: • kad je serumski kreatinin povišen, a otkrivena je još jedna abnormalnost (npr. proteinurija, znakovi Fanconijeva sindroma).
English: • The rules for treatment dose adjustments and interruption when target serum ferritin +/- liver iron concentration are reached.
Croatian: • pravila za prilagodbe terapijske doze i prekid liječenja kad se postigne ciljana koncentracija serumskog feritina +/- željeza u jetri
English: - if you have a low level of platelets or white blood cells in your blood test. - if you have blurred vision.
Croatian: - ako imate nizak broj krvnih pločica ili bijelih krvnih stanica u krvnoj pretrazi.
English: As a precaution, it is recommended that EXJADE is not used during pregnancy unless clearly necessary.
Croatian: Kao mjera opreza, ne preporučuje se primjenjivati EXJADE tijekom trudnoće, osim ako to nije posve neophodno.
English: Value 2 X and Y are the days (to be determined) when pre-treatment measurements should be performed.
Croatian: X i Y su dani (koji će biti određeni) prije početka liječenja kada je potrebno obaviti spomenuta mjerenja.
English: The MAH shall ensure that, at launch, in each Member State where EXJADE is marketed, all healthcare professionals and patients who are expected to prescribe, dispense and use EXJADE are provided with the following educational package for all available formulations (e.g. dispersible tablets, film-coated tablets and granules) for all indications:
Croatian: Nositelj odobrenja mora osigurati da se prilikom stavljanja lijeka na tržište u svakoj zemlji članici gdje se EXJADE nalazi na tržištu, svim zdravstvenim radnicima i bolesnicima za koje se očekuje da će propisivati, izdavati i primjenjivati EXJADE uruči sljedeći edukacijski paket za sve dostupne formulacije lijeka (npr. tablete za oralnu suspenziju, filmom obložene tablete i granule) i za sve indikacije:
English: Agents that may decrease EXJADE systemic exposure Deferasirox metabolism depends on UGT enzymes.
Croatian: Lijekovi koji mogu smanjiti sistemsku izloženost lijeku EXJADE Metabolizam deferasiroksa ovisi o UGT-enzimima.
English: • Medication errors due to switching between formulations (dispersible tablets and film-coated tablets/granules).
Croatian: • medikacijskih pogrešaka zbog prelaska s jedne na drugu formulaciju lijeka (tablete za oralnu suspenziju i filmom obložene tablete/granule).
English: The patient information pack should contain:
Croatian: Informacijski paket za bolesnike mora sadržavati:
English: • Paediatrics: either >ULN or creatinine clearance falls to <LLN at two consecutive visits.
Croatian: • pedijatrijski bolesnici: bilo >GGN ili kad klirens kreatinina padne na <DGN u dva uzastopna posjeta.
English: Therefore, the concomitant use of EXJADE with potent UGT inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) may result in a decrease in EXJADE efficacy.
Croatian: Zbog toga, istodobna primjena lijeka EXJADE s potentnim UGT-induktorima (npr. rifampicin, karbamazepin, fenitoin, fenobarbital, ritonavir) može imati za posljedicu smanjenje djelotvornosti lijeka EXJADE.
English: Each blister pack contains 30 or 90 film-coated tablets.
Croatian: Svako blister pakiranje sadrži 30 ili 90 filmom obloženih tableta.
English: • The importance of measuring creatinine clearance
Croatian: • važnost mjerenja klirensa kreatinina
English: Talk to your doctor or pharmacist before taking EXJADE: - if you have a kidney or liver problem.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete EXJADE: - ako imate probleme s bubrezima ili jetrom. - ako zbog preopterećenja željezom imate probleme sa srcem.
English: EXJADE can be used in children and adolescents receiving regular blood transfusions aged 2 years and over and in children and adolescents not receiving regular blood transfusions aged 10 years and over.
Croatian: EXJADE mogu uzimati djeca i adolescenti u dobi od 2 godine i stariji koji primaju redovite transfuzije krvi te djeca i adolescenti u dobi od 10 godina i stariji koji ne primaju redovite transfuzije krvi.
English: EXJADE has not been studied in patients with renal impairment and is contraindicated in patients with estimated creatinine clearance <60 ml/min (see sections 4.3 and 4.4).
Croatian: EXJADE nije ispitivan u bolesnika s oštećenjem bubrega te je kontraindiciran u bolesnika s procijenjenim klirensom kreatinina <60 ml/min (vidjeti dijelove 4.3 i 4.4).
English: How to take EXJADE:
Croatian: Kako uzimati EXJADE:
English: Multiple ulcers have been observed in some patients (see section 4.8).
Croatian: U nekih bolesnika opažene su višestruki ulkusi (vidjeti dio 4.8).
English: In addition, before treating heavily iron-overloaded children with non-transfusion-dependent thalassaemia with EXJADE, the physician should be aware that the consequences of long-term exposure in such patients are currently not known.
Croatian: Osim toga, prije primjene lijeka EXJADE u liječenju djece s talasemijom neovisnoj o transfuziji u kojih je došlo do teškog preopterećenja željezom, liječnik mora biti svjestan da posljedice dugotrajne izloženosti u tih bolesnika trenutačno nisu poznate.
English: What EXJADE is
Croatian: Što je EXJADE
English: • If you get reduced hearing, tell your doctor as soon as possible.
Croatian: • Ako Vam oslabi sluh, čim prije obavijestite svog liječnika.
English: The bioavailability (AUC) of deferasirox was moderately (approx. 13-25%) elevated when taken 30 minutes before meals with normal or high fat content.
Croatian: Bioraspoloživost (AUC) deferasiroksa umjereno se povećala (približno 13-25%) kada se uzimao 30 minuta prije obroka, bilo s normalnim ili visokim sadržajem masti.
English: The single dose Cmax was not affected, but an increase of theophylline Cmax is expected to occur with chronic dosing.
Croatian: Cmax se nije mijenjao nakon jednokratne doze, ali s kroničnim doziranjem očekuje se povećanje Cmax teofilina.
English: The tablet coating material contains: hypromellose; titanium dioxide (E171); macrogol (4000); talc; indigo carmine aluminium lake (E132).
Croatian: Ovojnica tablete sadrži: hipromelozu, titanijev dioksid (E171), makrogol (4000), talk, indigo carmine aluminium lake (E132).
English: It is recommended that serum ferritin be monitored every month and that the dose of EXJADE be adjusted, if necessary, every 3 to 6 months based on the trends in serum ferritin.
Croatian: Preporučuje se pratiti vrijednost serumskog feritina svaki mjesec i, ukoliko je potrebno, dozu lijeka EXJADE prilagođavati svakih 3 do 6 mjeseci, ovisno o trendovima kretanja serumskog feritina.
English: • That deferasirox causes rises in serum creatinine in some patients o The need to monitor serum creatinine
Croatian: • informacija o tome da deferasiroks uzrokuje povišenje serumskog kreatinina kod nekih bolesnika o potreba praćenja serumskog kreatinina
English: Gastrointestinal disorders
Croatian: gastrointestinalna perforacija
English: Each pack contains 30 sachets.
Croatian: Svako pakiranje sadrži 30 vrećica.
English: Care should be taken to maintain adequate hydration in patients who experience volume-depleting events (such as diarrhoea or vomiting), particularly in children with acute illness.
Croatian: Potrebno je paziti na održavanje odgovarajuće hidracije u bolesnika u kojih dođe do deplecije volumena (npr. uslijed proljeva ili povraćanja), osobito u djece s akutnom bolešću.
English: Treatment with EXJADE will be overseen by a doctor who is experienced in the treatment of iron overload caused by blood transfusions.
Croatian: Liječenje lijekom EXJADE će nadzirati liječnik iskusan u liječenju preopterećenja željezom, uzrokovanog transfuzijama krvi.
English: and/or Decreases <LLN* (<90 ml/min)
Croatian: i/ili smanjen <DGN-a* (<90 ml/min)
English: The underlying conditions requiring transfusion included beta-thalassaemia, sickle cell disease and other congenital and acquired anaemias (myelodysplastic syndromes [MDS], Diamond-Blackfan syndrome, aplastic anaemia and other very rare anaemias).
Croatian: Podležeća stanja, zbog kojih je bila nužna transfuzija, uključivala su beta-talasemiju, bolest srpastih stanica i druge nasljedne i stečene anemije (mijelodisplastični sindromi [MDS], Diamond-Blackfanov sindrom, aplastična anemija i ostale vrlo rijetke anemije).
English: • Take EXJADE granules either with or without a light meal.
Croatian: • EXJADE granule uzimajte uz lagani obrok ili bez njega.
English: 1, anaemia aggravated neutropenia
Croatian: 1, pogoršanje anemije