natgillin/translations-raw huggingface dataset:
Single events of increase in ALT and aspartate aminotransferase were reported in 20.0% and 8.3%, respectively, of the 145 patients who completed the study. 
Pojedinačni slučajevi porasta ALT-a i aspartat aminotransferaze prijavljeni su u 20,0% odnosno 8,3% od 145 bolesnika koji su završili ispitivanje.
The mean elimination half-life (t½) ranged from 8 to 16 hours. 
Srednja vrijednost poluvijeka eliminacije (t½) kretala se u rasponu od 8 do 16 sati.
At these same doses, the ratios of iron excretion: iron intake were 1.02 (indicating net iron balance) and 1.67 (indicating net iron removal), respectively. 
Pri istim dozama, omjeri izlučenog željeza i unesenog željeza bili su 1,02 (ukazuje na neto ravnotežu željeza) i 1,67 (ukazuje na neto uklanjanje željeza).
Acidbase balance should be monitored as clinically indicated in these populations. 
U toj populaciji se acido-bazna ravnoteža mora pratiti kako je klinički indicirano.
Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3. 
Glukuronidacija deferasiroksa uglavnom se zbiva posredstvom UGT1A1, a u manjoj mjeri i UGT1A3.
Cases of serious acute pancreatitis were observed without documented underlying biliary conditions. 
Zabilježeni su slučajevi ozbiljnog akutnog pankreatitisa bez dokumentiranih podležećih stanja žuči.
Value 2 
Vrijednost 2
(acquired Fanconi syndrome), glycosuria 
(stečeni Fanconijev sindrom), glikozurija
However, as a general precautionary measure in the management of paediatric patients with transfusional iron overload, body weight, height and sexual development should be monitored prior to therapy and at regular intervals (every 12 months). 
Međutim, kao opću mjeru predostrožnosti, pri liječenju pedijatrijskih bolesnika s preopterećenjem željezom zbog transfuzije potrebno je pratiti tjelesnu težinu, visinu i spolni razvoj prije terapije i u redovitim vremenskim razmacima (svakih 12 mjeseci).
Hepatitis, cholelithiasis 
hepatitis, kolelitijaza
It is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload). 
To je kelator željeza, lijek koji se koristi za uklanjanje viška željeza iz tijela (također se zove preopterećenje željezom).
Combination with other iron chelator therapies as the safety of such combinations has not been established (see section 4.5). 
Kombinacija s drugim terapijama kelacije željeza jer sigurnost tih kombinacija nije ustanovljena (vidjeti dio 4.5).
Since the interaction has not been established with dosages higher than 0.5 mg for repaglinide, the concomitant use of deferasirox with repaglinide should be avoided. 
Budući da interakcija nije bila ustanovljena s dozama višim od 0,5 mg repaglinida, treba izbjegavati istodobnu primjenu deferasiroksa s repaglinidom.
There are no data available on the retreatment of patients who reaccumulate iron after having achieved a satisfactory body iron level and therefore retreatment cannot be recommended. 
Nema dostupnih podataka o ponovnom liječenju bolesnika u kojih, nakon što je postignuta zadovoljavajuća razina željeza u organizmu, dođe do ponovne akumulacije željeza te se stoga ponovno liječenje ne može preporučiti.
Reduction of daily dose by 7 mg/kg/day (film-coated tablet formulation), if following renal parameters are observed at two consecutive visits and cannot be attributed to other causes 
Smanjenje dnevne doze za 7 mg/kg/dan (formulacija filmom obloženih tableta), ako su sljedeći bubrežni parametri uočeni tijekom dva uzastopna posjeta te se ne mogu pripisati drugim uzrocima
The dose should be immediately and completely consumed, and not stored for future use. 
Cijela doza se mora odmah uzeti i ne smije se pohraniti za buduću primjenu.
- First month after start of therapy or dose modification (including switch of formulation) 
- Prvi mjesec nakon uvođenja terapije ili izmjene doze (uključujući promjenu formulacije lijeka)
Gastrointestinal haemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, gastritis 
gastrointestinalno krvarenje, želučani ulkus (uključujući višestruke ulkuse), duodenalni ulkus, gastritis
The increases in Cmax due to the change in formulation and due to the effect of a high-fat meal may be additive and therefore, it is recommended that the film-coated tablets should be taken either on an empty stomach or with a light meal. 
Povećanja Cmax uzrokovana promjenom formulacije lijeka i učinkom punomasnog obroka mogla bi biti aditivna pa se stoga preporučuje da se filmom obložene tablete uzimaju ili na prazan želudac ili uz lagani obrok.
Adult patients 
Odrasli bolesnici
There is no specific antidote for deferasirox. 
Nema specifičnog antidota za deferasiroks.
Table 4 Summary of safety monitoring recommendations 
Tablica 4 Sažetak sigurnosnih preporuka za praćenje
Serum transaminases, bilirubin, alkaline phosphatase 
Serumske transaminaze, bilirubin, alkalna fosfataza
1, anaemia aggravated 
1, pogoršanje anemije
Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'. 
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „EXP“.
Deferasirox is highly (99%) protein bound to plasma proteins, almost exclusively serum albumin, and has a small volume of distribution of approximately 14 litres in adults. 
Deferasiroks se u visokom stupnju (99%) veže na proteine plazme, gotovo isključivo na serumski albumin te u odraslih ima mali volumen distribucije od približno 14 litara.
This age group may therefore require higher doses than are necessary in adults. 
U toj se dobnoj skupini, stoga, može pokazati potrebnim primjenjivati više doze nego u odraslih.
Decreases in mean creatinine clearance have been observed in both paediatric and adult patients with beta-thalassemia and iron overload during the first year of treatment, but there is evidence that this does not decrease further in subsequent years of treatment. 
Smanjenja u srednjoj vrijednosti klirensa kreatinina zapažena su i u pedijatrijskih i u odraslih bolesnika s beta-talasemijom i preopterećenjem željezom tijekom prve godine liječenja, no postoji dokaz da se on ne smanjuje dalje u narednim godinama liječenja.
When this results in a daily dose less than 14 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). 
Kada to rezultira dnevnom dozom manjom od 14 mg/kg tjelesne težine, mora se pratiti odgovor bolesnika i razmotriti povećanje doze ako se ne postigne dovoljna djelotvornost (vidjeti dio 5.1).
In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption. 
U preostale trećine bolesnika povišene vrijednosti serumskog kreatinina nisu uvijek reagirale na smanjenje doze ni prekid doziranja.
The absolute bioavailability of the film-coated tablet formulation has not been determined. 
Apsolutna bioraspoloživost formulacije filmom obloženih tableta nije ustanovljena.
In post-marketing reports, a high proportion of cases of metabolic acidosis occurred in children in the context of Fanconi syndrome. 
U izvješćima nakon stavljanja lijeka u promet pojavio se visok udio slučajeva metaboličke acidoze u djece u kontekstu Fanconijevog sindroma.
It is recommended that serum transaminases, bilirubin and alkaline phosphatase be checked before the initiation of treatment, every 2 weeks during the first month and monthly thereafter. 
Preporučuje se provjeriti serumske transaminaze, bilirubin i alkalnu fosfatazu prije početka liječenja, svaka 2 tjedna tijekom prvog mjeseca te nakon toga jednom mjesečno.
The results of the tests for serum creatinine, serum ferritin and serum transaminases should be recorded and regularly assessed for trends. 
Rezultate testova serumskog kreatinina, serumskog feritina i serumskih transaminaza potrebno je bilježiti i redovito procjenjivati trendove kretanja tih vrijednosti.
If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4). 
Ako se čini da je ta kombinacija neophodna, treba oprezno pratiti kliničke znakove i glukozu u krvi (vidjeti dio 4.4).
Doses above 14 mg/kg are not recommended because there is no experience with doses above this level in patients with non-transfusion-dependent thalassaemia syndromes. 
Doze iznad 14 mg/kg ne preporučuju se zbog toga što nema iskustva s dozama iznad te razine u bolesnika sa sindromima talasemije neovisnim o transfuziji.
Weekly during first month of therapy or after dose modification (including switch of formulation). 
Tjedno tijekom prvog mjeseca terapije ili nakon izmjene doze (uključujući promjenu formulacije lijeka).
This includes in particular: - other iron chelators, which must not be taken with Deferasirox Mylan, - antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as Deferasirox Mylan, 
To se posebno odnosi na: - druge kelatore željeza, koji se ne smiju uzimati s lijekom Deferasiroks Mylan, - antacide (lijekove koji se koriste za liječenje žgaravice) koji sadrže aluminij, koji se ne smiju uzimati u isto doba dana kada i Deferasiroks Mylan,
The safety of deferasirox in combination with other iron chelators has not been established. 
Sigurnost deferasiroksa u kombinaciji s drugim kelatorima željeza nije utvrđena.
Most of these patients had pre-existing haematological disorders that are frequently associated with bone marrow failure. 
Većina tih bolesnika je imala prethodne hematološke poremećaje koji su često povezani sa zatajenjem koštane srži.
If you feel dizzy after taking Deferasirox Mylan, do not drive or operate any tools or machines until you are feeling normal again. 
Ako nakon uzimanja lijeka Deferasiroks Mylan osjetite omaglicu, nemojte upravljati vozilima niti raditi s alatima ili strojevima sve dok se ponovno ne počnete osjećati normalno.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
Unutar svake skupine učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
If deferasirox and theophylline are used concomitantly, monitoring of theophylline concentration and theophylline dose reduction should be considered. 
Ako se deferasiroks i teofilin primjenjuju istodobno treba razmotriti praćenje koncentracije teofilina i smanjenje doze teofilina.
Hypersensitivity reactions (including anaphylactic reactions and angioedema) Metabolism and nutrition disorders Not known: 
reakcije preosjetljivosti (uključujući anafilaktičke reakcije i angioedem) Poremećaji metabolizma i prehrane Nepoznato:
Patients with estimated creatinine clearance <60 ml/min. 
Bolesnici s procijenjenim klirensom kreatinina < 60 ml/min.
Transfusions 
Transfuzije
Deferasirox Mylan is not recommended for children aged under 2 years. 
Deferasiroks Mylan se ne preporučuje za djecu mlađu od 2 godine.
The primary efficacy parameter was the change in liver iron concentration (LIC) from baseline after 12 months of treatment. 
Primarni parametar djelotvornosti bila je promjena koncentracije željeza u jetri (LIC) u odnosu na početnu vrijednost nakon 12 mjeseci liječenja.
Do not stop taking Deferasirox Mylan unless your doctor tells you to. 
Ne prekidajte uzimanje lijeka Deferasiroks Mylan, osim ako Vam to ne kaže liječnik.
Contraindicated 
Kontraindicirano
Safety monitoring schedules for renal and liver parameters are recommended. 
Preporučuje se napraviti rasporede sigurnosnog praćenja za bubrežne i jetrene parametre.
Elevations of transaminases greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon (0.3%). 
Povišenja transaminaza veća za 10 puta od gornje granice normalnog raspona, koja upućuju na hepatitis, bila su manje česta (0,3%).
McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland 
McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska
One third of deferoxamine dose 
Jedna trećina doze deferoksamina
Elderly patients The pharmacokinetics of deferasirox have not been studied in elderly patients (aged 65 or older). 
Stariji bolesnici Farmakokinetika deferasiroksa nije ispitivana u starijih bolesnika (u dobi od 65 godina ili starijih).
The absolute bioavailability (AUC) of deferasirox (dispersible tablet formulation) is about 70% compared to an intravenous dose. 
Apsolutna bioraspoloživost (AUC) deferasiroksa (formulacija tablete za oralnu suspenziju) je oko 70% u usporedbi s intravenskom dozom.
If such reactions occur, Deferasirox Mylan should be discontinued and appropriate medical intervention instituted. 
Ako nastupe takve reakcije, primjena lijeka Deferasiroks Mylan treba se prekinuti i poduzeti odgovarajuće medicinske intervencije.
The Cmax of deferasirox film-coated tablets was increased (by 29%) when taken with a high-fat meal. 
Cmax deferasiroks filmom obloženih tableta bila je povećana (za 29%) kada se lijek uzimao s obrokom s visokim sadržajem masnoća.
These were dose-dependent. 
Ta su povišenja ovisila o dozi.
• Take Deferasirox Mylan once a day, every day, at about the same time each day with some water. 
Kada uzimati Deferasiroks Mylan - Deferasiroks Mylan uzimajte jednom na dan, svaki dan, približno u isto vrijeme svakoga dana uz malo vode.
No effect on the offspring was noted. 
Nije uočen učinak na potomstvo.
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. 
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.
These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people). 
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).
The patient's response must be monitored and a dose increase should be considered if sufficient efficacy is not obtained (see section 5.1). 
Mora se pratiti odgovor bolesnika i razmotriti povišenje doze ako se ne postigne dovoljna djelotvornost (vidjeti dio 5.1).
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. 
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.
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. 
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.
>33% above pretreatment average and Decreases <LLN 
> 33% iznad prosjeka prije liječenja i smanjen < DGN-a
After a high-fat meal, AUC and Cmax were increased (by 18% and 29%, respectively). 
Nakon punomasnog obroka, AUC i Cmax bili su povišeni (za 18% odnosno 29%).
You will have regular blood and urine tests during treatment. 
Tijekom liječenja redovito ćete obavljati pretrage krvi i mokraće.
Elderly patients may experience more side effects (in particular diarrhoea) than younger patients. 
Stariji bolesnici mogu imati više nuspojava (osobito proljev) od mlađih bolesnika.
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. 
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.
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). 
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).
One of the secondary efficacy parameters was the change in serum ferritin between baseline and fourth quarter. 
Jedan od sekundarnih parametara djelotvornosti bio je promjena serumskog feritina od početne vrijednosti do četvrtog tromjesečja.
Doses above 28 mg/kg are not recommended because there is only limited experience with doses above this level (see section 5.1). 
Ne preporučuje se primjena doza iznad 28 mg/kg zbog ograničenog iskustva s dozama iznad te razine (vidjeti dio 5.1).
Standard procedures for management of overdose may be indicated as well as symptomatic treatment, as medically appropriate. 
Za zbrinjavanje predoziranja mogli bi biti indicirani standardni postupci kao i simptomatsko liječenje, ovisno o tome što je prikladno s medicinskog stajališta.
If disturbances are noted during the treatment, dose reduction or interruption may be considered. 
Ako se tijekom liječenja uoče poremećaji može se razmotriti smanjenje doze ili prekid liječenja.
How to store Deferasirox Mylan Contents of the pack and other information 
Kako čuvati Deferasiroks Mylan Sadržaj pakiranja i druge informacije
These reactions are dosedependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is continued. 
Te reakcije su ovisne o dozi, uglavnom su blage do umjerene, općenito prolazne i većinom nestaju i uz nastavak liječenja.
Transaminases increased 
povišene transaminaze
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 
Što je Deferasiroks Mylan i za što se koristi Što morate znati prije nego počnete uzimati Deferasiroks Mylan Kako uzimati Deferasiroks Mylan Moguće nuspojave
Deferasirox Mylan may decrease the efficacy of hormonal contraceptives (see section 4.5). 
Deferasiroks Mylan može smanjiti djelotvornost hormonskih kontraceptiva (vidjeti dio 4.5).
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. 
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.
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. 
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.
Auditory and ophthalmic testing (including fundoscopy) is recommended before the start of treatment and at regular intervals thereafter (every 12 months). 
Testiranje sluha i vida (uključujući fundoskopiju) preporučuje se prije početka liječenja i zatim u redovitim vremenskim razmacima (svakih 12 mjeseci).
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. 
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.
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. 
Cilj terapije, koja se sastoji od keliranja željeza, je ukloniti količinu željeza primljenu transfuzijom i, po potrebi, smanjiti postojeće opterećenje željezom.
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). 
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).
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. 
Za lijekove koje se metaboliziraju uglavnom putem CYP1A2 te imaju uzak terapijski indeks (npr. klozapin, tizanidin) vrijede iste preporuke kao i za teofilin.
Creatinine clearance and/or plasma cystatin C Prior to therapy. 
Klirens kreatinina i/ili cistatin C u plazmi
Deferasirox was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/− heterozygous mice in a 6-month study. 
Deferasiroks nije bio karcinogen u štakora u 2-godišnjem ispitivanju ni u transgeničnih p53+/− heterozigotnih miševa u 6-mjesečnom ispitivanju.
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. 
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.
In addition to monthly serum ferritin assessments, LIC should be monitored every three months when serum ferritin is ≤800 µg/l. 
Osim mjesečnog određivanja serumskog feritina, LIC je potrebno pratiti svaka 3 mjeseca kad je serumski feritin ≤ 800 µg/l.
The concomitant administration of deferasirox with anticoagulants may also increase the risk of gastrointestinal haemorrhage. 
Istodobna primjena deferasiroksa s antikoagulansima također može povećati rizik od gastrointestinalnog krvarenja.
ULN: upper limit of the normal range 
DGN: donja granica normalnog raspona ** GGN: gornja granica normalnog raspona
In animal studies, deferasirox was found to be rapidly and extensively secreted into maternal milk. 
Ispitivanja na životinjama pokazala su da se deferasiroks brzo i opsežno izlučuje u mlijeko ženki.
After dose reduction, interrupt treatment, if Adult and paediatric Remains >33% above pre-treatment average and/or Decreases <LLN 
Nakon smanjenja doze, prekid liječenja, ako Odrasli i pedijatrijski bolesnici ostaje > 33% iznad prosjeka prije liječenja i/ili smanjen < DGN-a
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). 
Pretragama će se pratiti i funkcija Vaših bubrega (razina kreatinina u krvi, prisutnost bjelančevina u mokraći) i jetrene funkcije (razina transaminaza u krvi).
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. 
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.
In some post-marketing cases, renal function deterioration has led to renal failure requiring temporary or permanent dialysis. 
U nekim slučajevima nakon stavljanja lijeka u promet pogoršanje funkcije bubrega je dovelo do zatajenja bubrega koje je zahtijevalo privremenu ili trajnu dijalizu.
Weekly and Weekly 
tjedno i tjedno