FrancophonIA/ELRC3.0 huggingface dataset:
English: • That rises in serum transaminases may occur in patients treated with EXJADE o The need for liver function tests prior to prescription, then at monthly intervals or more often if clinically indicated o Not to prescribe to patients with pre-existing severe hepatic disease o The need to interrupt treatment if persistent and progressive increase in liver enzyme were noted.
Croatian: • informacija o tome da u bolesnika liječenih lijekom EXJADE može doći do povišenja serumskih transaminaza o potreba za testovima jetrene funkcije prije propisivanja lijeka, a zatim u mjesečnim razmacima ili češće ako postoji klinička indikacija o da se ne propisuje bolesnicima s prethodnom teškom bolešću jetre o potreba prekida liječenja ako se uoči ustrajno i progresivno povišenje jetrenih enzima.
English: Monitoring - First month after start of therapy or dose modification (including switch of formulation)
Croatian: Praćenje - Prvi mjesec nakon uvođenja terapije ili izmjene doze (uključujući promjenu formulacije lijeka)
English: Caution should be exercised in patients who are taking EXJADE in combination with substances that have known ulcerogenic potential, such as NSAIDs, corticosteroids, or oral bisphosphonates, in patients receiving anticoagulants and in patients with platelet counts below 50,000/mm
Croatian: Nužan je oprez u bolesnika koji uzimaju EXJADE u kombinaciji s lijekovima koje imaju dokazani ulcerogeni potencijal, poput nesteroidnih protuupalnih lijekova, kortikosteroida ili oralnih bisfosfonata, u bolesnika koji primaju antikoagulanse, kao i u bolesnika s brojem trombocita ispod 50 000/mm
English: Tests of genotoxicity in vitro were negative (Ames test, chromosomal aberration test) while deferasirox caused formation of micronuclei in vivo in the bone marrow, but not liver, of non-iron-loaded rats at lethal doses.
Croatian: Testovi genotoksičnosti in vitro bili su negativni (Amesov test, test kromosomskih aberacija), a deferasiroks je in vivo pri letalnim dozama uzrokovao stvaranje mikronukleusa u koštanoj srži, ali ne i u jetri štakora koji nisu bili preopterećeni željezom.
English: In these patients, closer monitoring of LIC and serum ferritin is essential to avoid overchelation (see section 4.4).
Croatian: U tih je bolesnika ključno pozorno praćenje LIC-a i serumskog feritina kako bi se izbjegla prekomjerna kelacija (vidjeti dio 4.4).
English: If any SCAR is suspected, EXJADE should be discontinued immediately and should not be reintroduced.
Croatian: Ako se sumnja na bilo kakvu tešku kožnu nuspojavu, primjenu lijeka EXJADE potrebno je odmah prekinuti i ne smije se ponovno započeti.
English: • The maximum recommended daily dose for EXJADE dispersible tablets is 40 mg per kilogram body weight for patients receiving regular blood transfusions, 20 mg per kilogram body weight for adult patients not receiving regular blood transfusions and 10 mg per kilogram body weight for children and adolescents not receiving regular blood transfusions.
Croatian: • Najviša preporučena dnevna doza EXJADE tableta za oralnu suspenziju je 40 mg po kilogramu tjelesne težine za bolesnike koji primaju redovite transfuzije krvi, 20 mg po kilogramu tjelesne težine za odrasle bolesnike koji ne primaju redovite transfuzije krvi i 10 mg po kilogramu tjelesne težine za djecu i adolescente koji ne primaju redovite transfuzije krvi.
English: About two-thirds of the patients showing serum creatinine increase returned below the 33% level without dose adjustment.
Croatian: U oko dvije trećine bolesnika s povišenim serumskim kreatininom, one su se bez prilagodbe doze vratile ispod razine od 33%.
English: Patient guide should contain the following key elements: o Information on the need for regular monitoring, and when it should be carried out, of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin o Information that renal biopsy may be considered if significant renal abnormalities occur o Availability of several oral formulations (e.g. dispersible tablets, film-coated tablets and granules) and the main differences associated with these formulations (i.e., different posology regimen, different conditions of administration notably with food)
Croatian: Vodič za bolesnike mora sadržavati sljedeće ključne elemente: o informacije o potrebi redovitog praćenja serumskog kreatinina, klirensa kreatinina, proteinurije, jetrenih enzima, feritina i kada je te pretrage potrebno obaviti o informaciju o tome da je potrebno razmotriti mogućnost biopsije bubrega ako se pojave značajne abnormalnosti bubrega o raspoloživost nekoliko oralnih formulacija (npr. tablete za oralnu suspenziju, filmom obložene tablete i granule) i glavne razlike povezane s tim formulacijama lijeka (npr. različiti režimi doziranja, različiti uvjeti primjene osobito s obzirom na hranu)
English: Clinical efficacy and safety Clinical efficacy studies were conducted with deferasirox dispersible tablets.
Croatian: Klinička djelotvornost i sigurnost Ispitivanja kliničke djelotvornosti provedena su s deferasiroks tabletama za oralnu suspenziju.
English: EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
Croatian: EXJADE se ne preporučuje u bolesnika s teškim oštećenjem jetre (Child Pugh stadij C).
English: The absolute bioavailability of the granule formulation has not been determined.
Croatian: Apsolutna bioraspoloživost formulacije granula nije ustanovljena.
English: If you stop taking EXJADE
Croatian: Ako prestanete uzimati EXJADE
English: As a consequence, EXJADE therapy should be closely monitored to detect adverse reactions and to follow iron burden in the paediatric population.
Croatian: Zbog toga je terapiju lijekom EXJADE u pedijatrijskoj populaciji potrebno pažljivo pratiti kako bi se otkrile nuspojave i pratilo opterećenje željezom.
English: Twice (2x)
Croatian: Prije terapije dvaput (2x)
English: • The maximum recommended daily dose for EXJADE granules:
Croatian: • Najviša preporučena dnevna doza EXJADE granula je:
English: • Recommendations for treatment of non-transfusion-dependent thalassaemia (NTDT) syndromes: o Information that only one course of treatment is proposed for NTDT patients o A warning on the necessity of closer monitoring of liver iron concentration and serum ferritin in the paediatric population o A warning on the currently unknown safety consequences of long-term treatment in the paediatric population
Croatian: • preporuke za liječenje sindroma talasemije neovisne o transfuziji: o informacija da se za bolesnike sa sindromima talasemije neovisne o transfuziji predlaže samo jedan ciklus terapije o upozorenje o potrebi pozornijeg praćenja koncentracija željeza u jetri i serumskog feritina u pedijatrijskoj populaciji o upozorenje o trenutačno nepoznatim sigurnosnim posljedicama dugotrajnog liječenja u pedijatrijskoj populaciji
English: It is recommended that hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who develop unexplained changes in mental status while on Exjade therapy.
Croatian: Preporučuje se razmatranje hiperamonemične encefalopatije i mjerenje razina amonijaka u bolesnika u kojih dođe do neobjašnjivih promjena mentalnog stanja tijekom terapije lijekom EXJADE.
English: Total exposure (AUC) was approximately doubled when taken along with a high-fat breakfast (fat content >50% of calories) and by about 50% when taken along with a standard breakfast.
Croatian: Ukupna izloženost (AUC) otprilike se udvostručila nakon uzimanja lijeka uz punomasni doručak (sadržaj masti >50% kalorija), a nakon uzimanja lijeka uz standardni doručak povećala se za oko 50%.
English: In patients treated with doses >21 mg/kg/day
Croatian: U bolesnika liječenih dozama >21 mg/kg/dan
English: Interventional post-authorisation safety study (PASS): In order to assess the safety of deferasirox film-coated tablets in the paediatric population (especially when the tablets are crushed), the MAH shall conduct and submit the results of a safety study conducted according to an agreed protocol.
Croatian: Intervencijsko ispitivanje sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet (PASS): Radi procjene sigurnosti deferasiroks filmom obloženih tableta u pedijatrijskoj populaciji (posebno kada su tablete zdrobljene), nositelj odobrenja treba provesti i predati rezultate sigurnosnog ispitivanja provedenog u skladu s dogovorenim protokolom.
English: • Take the EXJADE dispersible tablets on an empty stomach.
Croatian: • EXJADE tablete za oralnu suspenziju uzimajte na prazan želudac.
English: It is recommended that treatment be started after the transfusion of approximately 20 units (about 100 ml/kg) of packed red blood cells (PRBC) or when there is evidence from clinical monitoring that chronic iron overload is present (e.g. serum ferritin >1,000 µg/l).
Croatian: Preporučuje se započeti liječenje nakon transfuzije od približno 20 jedinica (oko 100 ml/kg) koncentrata eritrocita (KE) ili kada na temelju kliničkog praćenja postoji dokaz kroničnog preopterećenja željezom (npr. serumski feritin >1000 µg/l).
English: • Disturbance in liver function tests
Croatian: • Poremećaj testova jetrene funkcije
English: In a 5-year observational study in which 267 children aged 2 to <6 years (at enrollment) with transfusional haemosiderosis received deferasirox, there were no clinically meaningful differences in the safety and tolerability profile of Exjade in paediatric patients aged 2 to <6 years compared to the overall adult and older paediatric population, including increases in serum creatinine of >33% and above the upper limit of normal on ≥2 consecutive occasions (3.1%), and elevation of alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (4.3%).
Croatian: 5-godišnjem opservacijskom ispitivanju u kojem je 267 djece u dobi od 2 do <6 godina (pri uključivanju u ispitivanje) s transfuzijskom hemosiderozom primalo deferasiroks, nije bilo klinički značajnih razlika u profilu sigurnosti i podnošljivosti lijeka Exjade u pedijatrijskih bolesnika u dobi od 2 do <6 godina u usporedbi s općom populacijom odraslih i starijih pedijatrijskih bolesnika, uključujući poraste u serumskom kreatininu od >33% i iznad gornje granice normale prilikom ≥2 uzastopne kontrole (3,1%), i porast alanin aminotransferaze (ALT) iznad 5-erostruke vrijednosti gornje granice normale (4,3%).
English: Starting dose 14 mg/kg/day 20 mg/kg/day After 20 units (about 100 ml/kg) of PRBC
Croatian: Početna doza 14 mg/kg/dan 20 mg/kg/dan Nakon 20 jedinica (oko 100 ml/kg)
English: • A warning on the risk of overchelation and on the necessity of close monitoring of serum ferritin levels and renal and hepatic function.
Croatian: • upozorenje o riziku od prekomjerne kelacije i o potrebi za pažljivim praćenjem razina serumskog feritina te bubrežne i jetrene funkcije
English: There have been reports of ulcers complicated with digestive perforation.
Croatian: Postoje izvještaji o ulkusima zakompliciranim s perforacijama probavnog sustava.
English: • Prescribers - a letter including the following dossiers: o A prescribers' guide informing about the switch between formulations in order to address the important potential risk of medication error for deferasirox o A patient's guide informing about the possibility of co-existing formulations in the EU market, and the differences concerning their administration, in order to address the important potential risk of medication error for deferasirox Additionally, prescribers and pharmacists will be informed via a specific letter regarding the timelines for removing EXJADE dispersible tablets from the EU market.
Croatian: • Liječnici propisivači - dopis sa sljedećim dokumentima: o Vodič za liječnike propisivače u kojem ih se obavještava o prelasku s jedne na drugu formulaciju lijeka radi ukazivanja na važne potencijalne rizike od medikacijskih pogrešaka za deferasiroks o Vodič za bolesnike u kojem ih se obavještava o mogućnosti istodobnog postojanja više formulacija lijeka na tržištu EU i o razlikama vezanim uz njihovu primjenu, radi ukazivanja na važne potencijalne rizike od medikacijskih pogrešaka za deferasiroks Uz to, liječnici propisivači i ljekarnici će putem posebnog dopisa biti obaviješteni o vremenskim okvirima za uklanjanje EXJADE tableta za oralnu suspenziju s EU tržišta.
English: The MAH shall use distinct outer cartons, blisters and tablets for all formulations (dispersible tablets and film-coated tablets/granules).
Croatian: Nositelj odobrenja će koristiti različite vanjske kutije, blistere i tablete za sve formulacije lijeka (tablete za oralnu suspenziju i filmom obložene tablete/granule).
English: Patients should be referred to a renal specialist, and further specialised investigations (such as renal biopsy) may be considered if the following occur despite dose reduction and interruption:
Croatian: Bolesnike treba uputiti nefrologu te razmotriti dodatne specijalističke preglede (poput biopsije bubrega) ukoliko, unatoč smanjenje doze ili prekidu liječenja, dođe do sljedećeg:
English: • Do not use any pack that is damaged or shows signs of tampering.
Croatian: • Ovaj lijek se ne smije upotrijebiti ako je pakiranje oštećeno ili su vidljivi znakovi otvaranja.
English: How long to take EXJADE
Croatian: Koliko dugo uzimati EXJADE
English: Once a satisfactory body iron level has been achieved (LIC <3 mg Fe/g dw or serum ferritin <300 µg/l), treatment should be stopped.
Croatian: Nakon što se postigne zadovoljavajuća razina željeza u tijelu (LIC <3 mg Fe/g težine suhog tkiva jetre ili serumski feritin <300 µg/l) liječenje je potrebno prekinuti.
English: o The need to consider renal biopsy:
Croatian: o potreba da se razmotri biopsija bubrega:
English: • Glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, phosphaturia, aminoaciduria (monitor as needed).
Croatian: • glikozurija u osoba koje nemaju šećernu bolest, niske razine natrija, fosfata, magnezija ili urata u serumu, fosfaturija, aminoacidurija (pratiti po potrebi).
English: In severe cases this reintroduction could be conducted in combination with a short period of oral steroid administration.
Croatian: U teškim slučajevima ponovno uvođenje lijeka može biti provedeno u kombinaciji s peroralnim steroidima tijekom kraćega perioda primjene.
English: EXJADE 500 mg dispersible tablets are also available in multipacks containing 294 (3 packs of 98) dispersible tablets.
Croatian: EXJADE 500 mg tablete za oralnu suspenziju su također dostupne u višestrukim pakiranjima koja sadrže 294 (3 pakiranja po 98) tableta za oralnu suspenziju.
English: • Severe upper stomach pain (pancreatitis)
Croatian: • Jaka bol u gornjem dijelu trbuha (pankreatitis)
English: Non-interventional post-authorisation safety study (PASS): In order to assess the long-term exposure and safety of deferasirox dispersible and film-coated tablets, the MAH should conduct an observational cohort study in paediatric non-transfusion-dependent thalassaemia patients over 10 years old for whom deferoxamine is contraindicated or inadequate conducted according to a CHMP-agreed protocol.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon dobivanja odobrenja za stavljanje lijeka u promet (PASS): Radi procjene dugotrajne izloženosti i sigurnosti deferasiroks tableta za oralnu suspenziju i filmom obloženih tableta, nositelj odobrenja treba provesti opservacijsko kohortno ispitivanje u pedijatrijskih bolesnika s talasemijom neovisnoj o transfuziji koji su stariji od 10 godina i za koje je deferoksamin kontraindiciran ili neodgovarajući, u skladu s protokolom ispitivanja s kojim se CHMP složio.
English: Consider interruption
Croatian: Razmatranje prekida
English: What EXJADE contains
Croatian: Što EXJADE sadrži
English: Deconjugation of glucuronidates in the intestine and subsequent reabsorption (enterohepatic recycling) is likely to occur: in a healthy volunteer study, the administration of cholestyramine after a single dose of deferasirox resulted in a 45% decrease in deferasirox exposure (AUC).
Croatian: Vjerojatno se može dogoditi dekonjugacija glukoronidata u crijevu i posljedična reapsorpcija (enterohepatičko kruženje): u ispitivanju na zdravim dobrovoljcima, primjena kolestiramina nakon jednokratne doze deferasiroksa je dovela do pada od 45% izloženosti deferasiroksu (AUC).
English: • Description of available deferasirox formulations (e.g. dispersible tablets, film-coated tablets and granules) o Different posology regimen o Different conditions of administration o Dose conversion table when switching from one formulation to another
Croatian: • opis dostupnih formulacija deferasiroksa (npr. tablete za oralnu suspenziju, filmom obložene tablete i granule) o različiti režimi doziranja o različiti uvjeti primjene o tablica za preračunavanje doze kod prelaska s jedne formulacije lijeka na drugu
English: How much EXJADE to take The dose of EXJADE is related to body weight for all patients.
Croatian: Koliko lijeka EXJADE uzeti Doza lijeka EXJADE u svakog bolesnika ovisi o njegovoj tjelesnoj težini.
English: Deferasirox also comes as “film-coated” tablets and granules.
Croatian: Deferasiroks je dostupan i u obliku „filmom obloženih“ tableta i granula.
English: During clinical studies, dose-dependent increases in serum creatinine occurred in about 36% of patients, though most remained within the normal range.
Croatian: Tijekom kliničkih ispitivanja, uočena su povišenja serumskog kreatinina ovisna o dozi u oko 36% bolesnika, iako je većina ostala unutar normalnog raspona.
English: If you forget to take EXJADE
Croatian: Ako ste zaboravili uzeti EXJADE
English: EXJADE is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2).
Croatian: EXJADE se ne preporučuje bolesnicima s teškim oštećenjem jetre (Child Pugh stadij C) (vidjeti dio 5.2).
English: • If you notice a marked decrease in your urine output (sign of kidney problem),
Croatian: • Ako primijetite izrazito smanjenje izlučivanja mokraće (znak bubrežnog problema),
English: If you have taken too much EXJADE, or if someone else accidentally takes your tablets, contact your doctor or hospital for advice straight away.
Croatian: Ako ste uzeli previše lijeka EXJADE, ili je tablete zabunom uzeo netko drugi, odmah se javite svome liječniku ili u bolnicu i zatražite savjet.
English: The bioavailability of deferasirox was increased to a variable extent when taken along with food.
Croatian: Bioraspoloživost deferasiroksa bila je povećana u različitom opsegu kada se lijek uzimao s hranom.
English: • If you get blurred or cloudy eyesight,
Croatian: • Ako Vam se zamagli ili zamuti vid,
English: Unit packs containing 30 or 90 film-coated tablets or multipacks containing 300 (10 packs of 30) film-coated tablets.
Croatian: Jedinično pakiranje sadrži 30 ili 90 filmom obloženih tableta ili višestruko pakiranje koje sadrži 300 (10 pakiranja po 30) filmom obloženih tableta.
English: Limited clinical data (29 patients with normal cardiac function at baseline) using MRI indicate that treatment with deferasirox 10-30 mg/kg/day (dispersible tablet formulation) for 1 year may also reduce levels of iron in the heart (on average, MRI T2* increased from 18.3 to 23.0 milliseconds).
Croatian: Ograničeni klinički podaci (29 bolesnika s normalnom funkcijom srca prije početka liječenja) dobiveni pomoću magnetske rezonancije (MRI) upućuju na zaključak da liječenje deferasiroksom u dozama od 10-30 mg/kg/dan (formulacija tablete za oralnu suspenziju) tijekom 1 godine može također smanjiti razine željeza u srcu (prosječno povećanje MRI T2* s 18,3 na 23,0 milisekunde).
English: • The need for annual auditory and ophthalmic testing
Croatian: • potreba za godišnjim pregledom sluha i vida
English: • Persistent abnormality in another marker of renal function (e.g. proteinuria, Fanconi Syndrome).
Croatian: • trajna abnormalnost drugog markera bubrežne funkcije (npr. proteinurija, Fanconijev sindrom).
English: >14 ml/kg/month of PRBC (approx. >4 units/month for an adult)
Croatian: >14 ml/kg/mjesec KE-a (otprilike >4 jedinice/mjesec za odraslu osobu)
English: After dose reduction, interrupt treatment, if Adult and paediatric Remains >33% above pre-treatment average and/or Decreases <LLN* (<90 ml/min)
Croatian: Nakon smanjenja doze, prekida liječenja, ako Odrasli i pedijatrijski bolesnici ostaje >33% iznad prosjeka prije liječenja i/ili smanjen <DGN-a* (<90 ml/min)
English: If you have taken too much EXJADE, or if someone else accidentally takes your granules, contact your doctor or hospital for advice straight away.
Croatian: Ako ste uzeli previše lijeka EXJADE, ili je granule zabunom uzeo netko drugi, odmah se javite svome liječniku ili u bolnicu i zatražite savjet.
English: When this results in a daily dose less than 20 mg/kg body weight, the patient's response must be monitored and a dose increase should be considered if sufficient efficacy is not obtained (see section 5.1).
Croatian: Kada to rezultira dnevnom dozom manjom od 20 mg/kg tjelesne težine, mora se pratiti odgovor bolesnika i razmotriti povećanje doze ako se ne postigne dovoljna djelotvornost (vidjeti dio 5.1).
English: • Patient information pack
Croatian: • Informacijski paket za bolesnike
English: In patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be considerably reduced followed by progressive increase up to a limit of 50% (see sections 4.4 and 5.2), and EXJADE must be used with caution in such patients.
Croatian: U bolesnika s umjerenim oštećenjem jetre (Child Pugh stadij B) dozu treba značajno sniziti nakon čega slijedi progresivno povećavanje doze do granice od 50% (vidjeti dijelove 4.4 i 5.2).
English: This includes in particular: - other iron chelators, which must not be taken with EXJADE, - antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as EXJADE, - ciclosporin (used to prevent the body rejecting a transplanted organ or for other conditions, such as rheumatoid arthritis or atopic dermatitis), - simvastatin (used to lower cholesterol), - certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids), - oral bisphosphonates (used to treat osteoporosis), - anticoagulant medicines (used to prevent or treat blood clotting), - hormonal contraceptive agents (birth control medicines), - bepridil, ergotamine (used for heart problems and migraines), - repaglinide (used to treat diabetes), - rifampicin (used to treat tuberculosis), - phenytoin, phenobarbital, carbamazepine (used to treat epilepsy), - ritonavir (used in the treatment of HIV infection), - paclitaxel (used in cancer treatment), - theophylline (used to treat respiratory diseases such as asthma), - clozapine (used to treat psychiatric disorders such as schizophrenia), - tizanidine (used as a muscle relaxant), - cholestyramine (used to lower cholesterol levels in the blood), - busulfan (used as a treatment prior to transplantation in order to destroy the original bone marrow before the transplant).
Croatian: kortikosteroidi), - oralne bisfosfonate (koriste se za liječenje osteoporoze), - antikoagulantne lijekove (koriste se za sprečavanje ili liječenje krvnih ugrušaka), - hormonske kontraceptivne lijekove (lijekovi za kontrolu začeća), - bepridil, ergotamin (koristi se za liječenje srčanih problema i migrene), - repaglinid (koristi se za liječenje šećerne bolesti), - rifampicin (koristi se za liječenje tuberkuloze), - fenitoin, fenobarbital, karbamazepin (koriste se za liječenje epilepsije), - ritonavir (koristi se za liječenje HIV infekcije), - paklitaksel (koristi se za liječenje raka), - teofilin (koristi se za liječenje bolesti dišnih puteva poput astme), - klozapin (koristi se za liječenje psihijatrijskih poremećaja poput shizofrenije), - tizanidin (koristi se kao lijek za opuštanje mišića), - kolestiramin (koristi se za snižavanje razina kolesterola u krvi), - busulfan (koji se koristi kao terapija prije transplantacije radi uništavanja postojeće koštane srži prije transplantacije).