FrancophonIA/ELRC3.0 huggingface dataset:
English: • Take Deferasirox Mylan once a day, every day, at about the same time each day with some water.
Croatian: Kada uzimati Deferasiroks Mylan - Deferasiroks Mylan uzimajte jednom na dan, svaki dan, približno u isto vrijeme svakoga dana uz malo vode.
English: No effect on the offspring was noted.
Croatian: Nije uočen učinak na potomstvo.
English: Your doctor will take these tests into consideration when deciding on the dose of Deferasirox Mylan most suitable for you and will also use these tests to decide when you should stop taking Deferasirox Mylan.
Croatian: Liječnik će uzeti u obzir nalaze tih pretraga prilikom odlučivanja o najprikladnijoj dozi lijeka Deferasiroks Mylan za Vas, a na temelju tih pretraga će odlučiti i kada morate prekinuti uzimanje lijeka Deferasiroks Mylan.
English: These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people).
Croatian: Ove nuspojave su manje česte (mogu se javiti u do 1 na 100 osoba) ili rijetke (mogu se javiti u do 1 na 1000 osoba).
English: UNITED KINGDOM
Croatian: UJEDINJENO KRALJEVSTVO
English: 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: Mora se pratiti odgovor bolesnika i razmotriti povišenje doze ako se ne postigne dovoljna djelotvornost (vidjeti dio 5.1).
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 Deferasirox Mylan 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 Deferasiroks Mylan može biti ograničena i može biti manja od rizika.
English: Once the cause of the liver function test abnormalities has been clarified or after return to normal levels, cautious re-initiation of treatment at a lower dose followed by gradual dose escalation may be considered.
Croatian: Nakon što se otkrije uzrok abnormalnosti testova jetrene funkcije, ili nakon povrata na normalne razine, može se razmotriti ponovno oprezno uvođenje liječenja nižom dozom, koja se postupno može povećavati.
English: >33% above pretreatment average and Decreases <LLN
Croatian: > 33% iznad prosjeka prije liječenja i smanjen < DGN-a
English: After a high-fat meal, AUC and Cmax were increased (by 18% and 29%, respectively).
Croatian: Nakon punomasnog obroka, AUC i Cmax bili su povišeni (za 18% odnosno 29%).
English: You will have regular blood and urine tests during treatment.
Croatian: Tijekom liječenja redovito ćete obavljati pretrage krvi i mokraće.
English: Elderly patients may experience more side effects (in particular diarrhoea) than younger patients.
Croatian: Stariji bolesnici mogu imati više nuspojava (osobito proljev) od mlađih bolesnika.
English: This imbalance occurred because patients on deferoxamine were allowed to remain on their pre-study dose even if it was higher than the protocol specified dose.
Croatian: Ta neravnoteža se dogodila jer su bolesnici liječeni deferoksaminom mogli nastaviti uzimati dozu koju su primali i prije kliničkog ispitivanja, čak i ako je ta doza bila viša od one definirane protokolom.
English: The film-coated tablets should be taken once a day, preferably at the same time each day, and may be taken on an empty stomach or with a light meal (see sections 4.5 and 5.2).
Croatian: Filmom obložene tablete moraju se uzimati jedanput na dan, po mogućnosti u isto vrijeme svakog dana i mogu se uzeti na prazan želudac ili uz lagani obrok (vidjeti dijelove 4.5 i 5.2).
English: One of the secondary efficacy parameters was the change in serum ferritin between baseline and fourth quarter.
Croatian: Jedan od sekundarnih parametara djelotvornosti bio je promjena serumskog feritina od početne vrijednosti do četvrtog tromjesečja.
English: Doses above 28 mg/kg are not recommended because there is only limited experience with doses above this level (see section 5.1).
Croatian: Ne preporučuje se primjena doza iznad 28 mg/kg zbog ograničenog iskustva s dozama iznad te razine (vidjeti dio 5.1).
English: Standard procedures for management of overdose may be indicated as well as symptomatic treatment, as medically appropriate.
Croatian: Za zbrinjavanje predoziranja mogli bi biti indicirani standardni postupci kao i simptomatsko liječenje, ovisno o tome što je prikladno s medicinskog stajališta.
English: If disturbances are noted during the treatment, dose reduction or interruption may be considered.
Croatian: Ako se tijekom liječenja uoče poremećaji može se razmotriti smanjenje doze ili prekid liječenja.
English: How to store Deferasirox Mylan Contents of the pack and other information
Croatian: Kako čuvati Deferasiroks Mylan Sadržaj pakiranja i druge informacije
English: These reactions are dosedependent, 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: Transaminases increased
Croatian: povišene transaminaze
English: What Deferasirox Mylan is and what it is used for What you need to know before you take Deferasirox Mylan How to take Deferasirox Mylan Possible side effects
Croatian: Što je Deferasiroks Mylan i za što se koristi Što morate znati prije nego počnete uzimati Deferasiroks Mylan Kako uzimati Deferasiroks Mylan Moguće nuspojave
English: Deferasirox Mylan may decrease the efficacy of hormonal contraceptives (see section 4.5).
Croatian: Deferasiroks Mylan može smanjiti djelotvornost hormonskih kontraceptiva (vidjeti dio 4.5).
English: Physicians and patients should remain alert for signs and symptoms of gastrointestinal ulceration and haemorrhage during Deferasirox Mylan 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 Deferasiroks Mylan te odmah započeti dodatne pretrage i liječenje u slučaju sumnje na ozbiljnu gastrointestinalnu nuspojavu.
English: The principal analysis of the pivotal comparative study in 586 patients suffering from betathalassaemia 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: Auditory and ophthalmic testing (including fundoscopy) is recommended before the start of treatment and at regular intervals thereafter (every 12 months).
Croatian: Testiranje sluha i vida (uključujući fundoskopiju) preporučuje se prije početka liječenja i zatim u redovitim vremenskim razmacima (svakih 12 mjeseci).
English: Deferasirox Mylan 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: Deferasiroks Mylan 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: The goals of iron chelation therapy are to remove the amount of iron administered in transfusions and, as required, to reduce the existing iron burden.
Croatian: Cilj terapije, koja se sastoji od keliranja željeza, je ukloniti količinu željeza primljenu transfuzijom i, po potrebi, smanjiti postojeće opterećenje željezom.
English: Therefore, due to a possible decrease in efficacy, caution should be exercised when deferasirox is combined with substances metabolised through CYP3A4 (e.g. ciclosporin, simvastatin, hormonal contraceptive agents, bepridil, ergotamine).
Croatian: Stoga je zbog mogućeg smanjenja djelotvornosti nužan oprez kada se deferasiroks kombinira s lijekovima koji se metaboliziraju preko CYP3A4 (npr. ciklosporin, simvastatin, hormonski kontraceptivni lijekovi, bepridil, ergotamin).
English: For substances that are predominantly metabolised by CYP1A2 and that have a narrow therapeutic index (e.g. clozapine, tizanidine), the same recommendations apply as for theophylline.
Croatian: Za lijekove koje se metaboliziraju uglavnom putem CYP1A2 te imaju uzak terapijski indeks (npr. klozapin, tizanidin) vrijede iste preporuke kao i za teofilin.
English: Creatinine clearance and/or plasma cystatin C Prior to therapy.
Croatian: Klirens kreatinina i/ili cistatin C u plazmi
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: 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: 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: The concomitant administration of deferasirox with anticoagulants may also increase the risk of gastrointestinal haemorrhage.
Croatian: Istodobna primjena deferasiroksa s antikoagulansima također može povećati rizik od gastrointestinalnog krvarenja.
English: ULN: upper limit of the normal range
Croatian: DGN: donja granica normalnog raspona ** GGN: gornja granica normalnog raspona
English: In animal studies, deferasirox was found to be rapidly and extensively secreted into maternal milk.
Croatian: Ispitivanja na životinjama pokazala su da se deferasiroks brzo i opsežno izlučuje u mlijeko ženki.
English: After dose reduction, interrupt treatment, if Adult and paediatric Remains >33% above pre-treatment average and/or Decreases <LLN
Croatian: Nakon smanjenja doze, prekid liječenja, ako Odrasli i pedijatrijski bolesnici ostaje > 33% iznad prosjeka prije liječenja i/ili smanjen < DGN-a
English: The tests will also monitor your kidney function (blood level of creatinine, presence of protein in the urine) and liver function (blood level of transaminases).
Croatian: Pretragama će se pratiti i funkcija Vaših bubrega (razina kreatinina u krvi, prisutnost bjelančevina u mokraći) i jetrene funkcije (razina transaminaza u krvi).
English: Serum ferritin assessed by monthly monitoring reflected changes in liver iron concentration indicating that trends in serum ferritin can be used to monitor response to therapy.
Croatian: Serumski feritin određivan jednom mjesečno odražavao je promjene u koncentraciji željeza u jetri, što upućuje na zaključak da se trendovi promjena serumskog feritina mogu koristiti za praćenje odgovora na terapiju.
English: In some post-marketing cases, renal function deterioration has led to renal failure requiring temporary or permanent dialysis.
Croatian: U nekim slučajevima nakon stavljanja lijeka u promet pogoršanje funkcije bubrega je dovelo do zatajenja bubrega koje je zahtijevalo privremenu ili trajnu dijalizu.
English: Weekly and Weekly
Croatian: tjedno i tjedno
English: Approximate tablet dimensions 17 mm × 6.7 mm.
Croatian: Približne dimenzije tablete 17 mm × 6,7 mm.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Croatian: reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS)
English: Therefore, it must not be combined with other iron chelator therapies (see section 4.3).
Croatian: Stoga se lijek ne smije kombinirati s drugim terapijama kelacije željeza (vidjeti dio 4.3).
English: Table 3 Dose adjustment and interruption of treatment for renal monitoring
Croatian: Tablica 3 Prilagođavanje doze i prekid liječenja u slučaju praćenja funkcije bubrega
English: Immune system disorders Not known:
Croatian: Poremećaji imunološkog sustava Nepoznato:
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: Adjustment Steps (every 3
Croatian: Koraci u prilagodbi doze (svakih 36 mjeseci)
English: Renal excretion of deferasirox and its metabolites is minimal (8% of the dose).
Croatian: Izlučivanje deferasiroksa i njegovih metabolita bubrezima je minimalno (8% doze).
English: In case of switching from dispersible tablets to film-coated tablets, the dose of the film-coated tablets should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole tablet.
Croatian: U slučaju prelaska s tableta za oralnu suspenziju na filmom obložene tablete, doza filmom obloženih tableta treba biti 30% manja od doze tableta za oralnu suspenziju, zaokruženo na najbližu cijelu tabletu.
English: The dosing recommendations for paediatric patients aged 2 to 17 years with transfusional iron overload are the same as for adult patients (see section 4.2).
Croatian: Preporučeno doziranje za pedijatrijske bolesnike u dobi od 2 do 17 godina s transfuzijskim preopterećenjem željezom je isto kao i za odrasle bolesnike (vidjeti dio 4.2).
English: Patients with pre-existing renal conditions and patients who are receiving medicinal products that depress renal function may be more at risk of complications.
Croatian: Bolesnici s već postojećim bubrežnim poremećajima i bolesnici koji primaju lijekove koji smanjuju funkciju bubrega mogu imati veći rizik od komplikacija.
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 povećan je za 22%.
English: Other considerations
Croatian: Druga razmatranja
English: It is recommended that serum ferritin be monitored every month and that the dose of Deferasirox 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 deferosiraksa prilagođavati svakih 3 do 6 mjeseci, ovisno o trendovima kretanja serumskog feritina.
English: Although deferasirox has a lower affinity for aluminium than for iron, it is not recommended to take deferasirox tablets with aluminium-containing antacid preparations.
Croatian: Premda je afinitet deferasiroksa za aluminij niži nego za željezo, ne preporučuje se uzimati deferasiroks tablete istodobno s antacidima koji sadrže aluminij.
English: Multiple ulcers have been observed in some patients (see section 4.8).
Croatian: U nekih bolesnika opaženi su višestruki ulkusi (vidjeti dio 4.8).
English: Studies in animals have shown some reproductive toxicity at maternally toxic doses (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su određenu reproduktivnu toksičnost pri dozama toksičnima za gravidne ženke (vidjeti dio 5.3).
English: [Unit dose blisters] 30 × 1 film-coated tablets
Croatian: [Blisteri djeljivi na jedinične doze] 30 × 1 filmom obložena tableta
English: If any of these apply to you, tell your doctor straight away.
Croatian: Ako se bilo što od navedenog odnosi na Vas, odmah obavijestite svog liječnika.
English: Elevations of liver transaminases were reported as an adverse reaction in 2% of patients.
Croatian: Povišenja jetrenih transaminaza prijavljena su kao nuspojave u 2% bolesnika.
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: Care should be taken to maintain adequate hydration in patients who develop diarrhoea or vomiting.
Croatian: Nužan je oprez kako bi se održala odgovarajuća hidracija u bolesnika koji razviju proljev ili povraćanje.
English: Abnormal serum creatinine and creatinine clearance values were reported in 5.5% and 1.8% of patients, respectively.
Croatian: Abnormalne vrijednosti serumskog kreatinina bile su prijavljene u 5,5%, a klirensa kreatinina u 1,8% bolesnika.
English: The kidney toxicity is considered mainly due to iron deprivation in animals that were not previously overloaded with iron.
Croatian: Smatra se da je bubrežna toksičnost najvećim dijelom posljedica gubitka željeza u životinja koje prethodno nisu bile preopterećene željezom.
English: Dose adjustments may be made in steps of 3.5 to 7 mg/kg and are to be tailored to the individual patient's response and therapeutic goals (maintenance or reduction of iron burden).
Croatian: Prilagodbe doze, ako je potrebno, se mogu provoditi u koracima po 3,5 do 7 mg/kg, vodeći računa o individualnom odgovoru bolesnika i terapijskim ciljevima (održavanje ili smanjenje opterećenja željezom).
English: In animals, no adverse effects on male or female fertility were found (see section 5.3).
Croatian: U životinja nisu uočene nuspojave na plodnost mužjaka ni ženki (vidjeti dio 5.3).
English: Data in children with non-transfusion-dependent thalassaemia are very limited (see section 5.1).
Croatian: Podaci o primjeni u djece s talasemijom neovisnoj o transfuziji vrlo su ograničeni (vidjeti dio 5.1).
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 deferasirox (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 deferasiroksom (uključujući promjenu formulacije lijeka), a zatim jednom mjesečno.
English: They should be monitored closely by their doctor for side effects that may require a dose adjustment.
Croatian: Njihov ih liječnik treba pažljivo pratiti s obzirom na nuspojave jer će možda biti potrebna prilagodba doze.
English: Deferasirox (dispersible tablet formulation) is absorbed following oral administration with a median time to maximum plasma concentration (tmax) of about 1.5 to 4 hours.
Croatian: Deferasiroks (formulacija tablete za oralnu suspenziju) se nakon peroralne primjene apsorbira s medijanom vremena do najviše koncentracije (tmax) u plazmi od oko 1,5 do 4 sata.
English: In a study to assess the safety of deferasirox film-coated and dispersible tablets, 173 adult and paediatric patients with transfusion dependent thalassaemia or myelodysplastic syndrome were treated for 24 weeks.
Croatian: U ispitivanju za procjenu sigurnosti deferasiroks filmom obloženih tableta i tableta za oralnu suspenziju, 173 odrasla i pedijatrijska bolesnika s talasemijom ovisnom o transfuziji ili mijelodisplastičnim sindromom liječeni su tijekom 24 tjedana.
English: If no satisfactory control is achieved at doses above 21 mg/kg, treatment at such doses should not be maintained and alternative treatment options should be considered whenever possible.
Croatian: Ako se pri dozama iznad 21 mg/kg ne postiže zadovoljavajuća kontrola, liječenje takvim dozama se ne treba nastaviti i potrebno je razmotriti druge mogućnosti liječenja kad god je to moguće.
English: Women of childbearing potential are recommended to use additional or alternative non-hormonal methods of contraception when using Deferasirox Mylan.
Croatian: Ženama u reproduktivnoj dobi se preporučuje korištenje dodatne ili zamjenske nehormonske metode kontracepcije tijekom primjene lijeka Deferasiroks Mylan.
English: For adults not assessed and ≤2,000 µg/l
Croatian: Nije procijenjeno i ≤ 2000 µg/l
English: Therefore, the concomitant use of Deferasirox Mylan with potent UGT inducers (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, ritonavir) may result in a decrease in Deferasirox Mylan efficacy.
Croatian: Zbog toga, istodobna primjena lijeka Deferasiroks Mylan s potentnim UGT-induktorima (npr. rifampicin, karbamazepin, fenitoin, fenobarbital, ritonavir) može imati za posljedicu smanjenje djelotvornosti lijeka Deferasiroks Mylan.
English: Care should be taken to maintain adequate hydration in patients who experience volumedepleting 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: Fifty-six patients under the age of 6 years participated in this pivotal study, 28 of them receiving deferasirox dispersible tablets.
Croatian: U tom ključnom kliničkom ispitivanju sudjelovalo je 56 bolesnika mlađih od 6 godina, od kojih je njih 28 primalo deferasiroks tablete za oralnu suspenziju.
English: The tablet coating material contains: hypromellose, titanium dioxide (E171), macrogol/PEG (6000), talc, iron oxide yellow (E172), iron oxide red (E172).
Croatian: Ovojnica tablete sadrži: hipromelozu, titanijev dioksid (E171), makrogol/PEG (6000), talk, željezov oksid, žuti (E172), željezov oksid, crveni (E172).
English: Continue taking Deferasirox Mylan every day for as long as your doctor tells you.
Croatian: Deferasiroks Mylan uzimajte svakog dana, onoliko dugo koliko Vam je rekao liječnik.
English: Patients experiencing the uncommon adverse reaction of dizziness should exercise caution when driving or operating machines (see section 4.8).
Croatian: Bolesnici u kojih se javlja omaglica kao manje česta nuspojava moraju biti oprezni pri upravljanju vozilima ili radu na strojevima (vidjeti dio 4.8).
English: Also, there have been reports of fatal gastrointestinal haemorrhages, especially in elderly patients who had haematological malignancies and/or low platelet counts.
Croatian: Također, bila su prijavljena gastrointestinalna krvarenja sa smrtnim ishodom, osobito u starijih bolesnika sa zloćudnim hematološkim bolestima i/ili niskim brojem trombocita.
English: Hepatic and renal disorders have been reported, including cases of liver enzyme and creatinine increased with recovery after treatment discontinuation.
Croatian: Bili su prijavljeni jetreni i bubrežni poremećaji, uključujući slučajeve povišenja jetrenih enzima i kreatinina čije su se vrijednosti vratile u normalu nakon prestanka liječenja.
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 povećanje Cmax teofilina.
English: After 20 units (about 100 ml/kg) of PRBC
Croatian: Nakon 20 jedinica (oko 100 ml/kg) KE-a ili > 1000 μg/l
English: LIC is the preferred method of iron overload determination and should be used wherever available.
Croatian: LIC je preferirana metoda određivanja preopterećenja željezom koju treba primjenjivati kad god je to moguće.