natgillin/translations-raw huggingface dataset:
In patients whose serum ferritin level has reached the target (usually between 500 and 1,000 µg/l), dose reductions in steps of 3.5 to 7 mg/kg should be considered to maintain serum ferritin levels within the target range and to minimise the risk of overchelation. 
U bolesnika u kojih je razina feritina u serumu dostigla cilj (obično između 500 i 1000 µg/l) treba se razmotriti snižavanje doze u koracima od 3,5 do 7 mg/kg kako bi se održale razine feritina u serumu unutar ciljnog raspona te kako bi se rizik od prekomjerne kelacije sveo na najmanju moguću mjeru.
Deferasirox Mylan can be used by people aged 65 years and over at the same dose as for other adults. 
Osobe u dobi od 65 godina i više mogu uzimati Deferasiroks Mylan u istim dozama kao i druge odrasle osobe.
Deferasirox Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'. 
Deferasiroks Mylan sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
In two clinical studies, growth and sexual development of paediatric patients treated with deferasirox for up to 5 years were not affected (see section 4.4). 
U dva klinička ispitivanja rast i spolni razvoj pedijatrijskih bolesnika liječenih deferasiroksom u trajanju do 5 godina nije bio oštećen (vidjeti dio 4.4).
The majority of these patients had renal impairment, renal tubulopathy (Fanconi syndrome) or diarrhoea, or conditions where acid-base imbalance is a known complication (see section 4.4). 
Većina tih bolesnika imala je oštećenje bubrega, bubrežnu tubulopatiju (Fanconijev sindrom) ili proljev, ili stanja kod kojih je acido-bazna neravnoteža poznata komplikacija (vidjeti dio 4.4).
◦ The need to interrupt treatment after a dose reduction if serum creatinine rises: Adults and Paediatrics: remain >33% above baseline or creatinine clearance <LLN (90 ml/min) 
◦ potreba da se prekine liječenje nakon smanjenja doze u slučaju porasta serumskog kreatinina: odrasli i pedijatrijski bolesnici: ostaje > 33% iznad početne vrijednosti ili klirens kreatinina < DGN (90 ml/min)
What Deferasirox Mylan is and what it is used for 
Što je Deferasiroks Mylan i za što se koristi
Deferasirox Mylan is not recommended in patients with severe hepatic impairment (Child-Pugh Class C). 
Deferasiroks Mylan se ne preporučuje u bolesnika s teškim oštećenjem jetre (Child Pugh stadij C).
Clinical efficacy studies were conducted with deferasirox dispersible tablets. 
Ispitivanja kliničke djelotvornosti provedena su s deferasiroks tabletama za oralnu suspenziju.
No clinical data on exposed pregnancies are available for deferasirox. 
Ne postoje klinički podaci o izloženosti deferasiroksu u trudnoći.
• 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) 
- 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) - Gubitak kose - Bubrežni kamenci - Slabo mokrenje
Hepatic failure Skin and subcutaneous tissue disorders Common: 
Poremećaji kože i potkožnog tkiva Često:
The availability of long-term efficacy and safety data from clinical studies conducted with deferasirox dispersible tablets used at doses above 30 mg/kg is currently limited (264 patients followed for an average of 1 year after dose escalation). 
Trenutačno se raspolaže tek ograničenim podacima iz provedenih kliničkih ispitivanja o dugotrajnoj djelotvornosti i sigurnosti deferasiroks tableta za oralnu suspenziju pri dozama iznad 30 mg/kg (264 bolesnika koji su bili praćeni prosječno 1 godinu nakon povećavanja doze).
CYP450-catalysed (oxidative) metabolism of deferasirox appears to be minor in humans (about 8%). 
Izgleda da je u ljudi metabolizam deferasiroksa (oksidativni) kataliziran s CYP450 vrlo slabo zastupljen (oko 8%).
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which could be life- threatening or fatal, have been reported. 
Prijavljene su teške kožne nuspojave uključujući Stevens-Johnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) i reakciju na lijek s eozinofilijom i sistemskim simptomima (engl. drug reaction with eosinophilia and systemic symptoms, DRESS), koje mogu biti opasne po život ili smrtonosne.
Deferasirox Mylan film-coated tablets may be taken either on an empty stomach or with a light meal, preferably at the same time each day (see sections 4.2 and 5.2). 
Deferasiroks Mylan filmom obložene tablete mogu se uzimati ili na prazan želudac ili uz lagani obrok, po mogućnosti svakoga dana u isto vrijeme (vidjeti dijelove 4.2 i
Pyrexia, oedema, fatigue 
pireksija, edem, umor
Vision and hearing 
Ispitivanje sluha i vida
How much Deferasirox Mylan to take The dose of Deferasirox Mylan is related to body weight for all patients. 
Koliko lijeka Deferasiroks Mylan uzeti Doza lijeka Deferasiroks Mylan u svakog bolesnika ovisi o njegovoj tjelesnoj težini.
◦ The need to reduce by 10 mg/kg the dose if serum creatinine rises: Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min) Paediatrics: either >ULN or creatinine clearance falls to <LLN at two consecutive visits. 
◦ potreba smanjenja doze za 10 mg/kg ako dođe do rasta serumskog kreatinina: odrasli bolesnici: > 33% iznad početne vrijednosti i klirens kreatinina < DGN (90 ml/min) pedijatrijski bolesnici: bilo > GGN ili kad klirens kreatinina padne na < DGN u dva uzastopna posjeta.
• 14 mg per kilogram body weight for adult patients not receiving regular blood transfusions, 
• 14 mg po kilogramu tjelesne težine za odrasle bolesnike koji ne primaju redovite transfuzije krvi,
It appeared from preclinical and clinical studies that deferasirox dispersible tablets could be as active as deferoxamine when used in a dose ratio of 2:1 (i.e. a dose of deferasirox dispersible tablets that is numerically half of the deferoxamine dose). 
Pretklinička i klinička ispitivanja pokazala su, čini se, da bi deferasiroks tablete za oralnu suspenziju mogle biti jednako aktivne kao i deferoksamin ako bi se primjenjivale u omjeru doza 2:1 (tj. doza deferasiroks tableta za oralnu suspenziju trebala bi iznositi polovicu brojčane vrijednosti doze deferoksamina).
However, in patients with liver iron concentration <7 mg Fe/g dw treated with deferasirox dispersible tablets (5 and 10 mg/kg) or deferoxamine (20 to 35 mg/kg), non-inferiority was not established due to imbalance in the dosing of the two chelators. 
Međutim, u bolesnika s koncentracijom željeza u jetri < 7 mg Fe/g suhe težine liječenih deferasiroks tabletama za oralnu suspenziju (5 i 10 mg/kg) ili deferoksaminom (20 do 35 mg/kg) neinferiornost nije potvrđena zbog neravnoteže u doziranju dvaju kelatora.
For patients who are unable to swallow whole tablets, Deferasirox Mylan film-coated tablets may be crushed and taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple). 
Za bolesnike koji ne mogu progutati cijele tablete, Deferasiroks Mylan filmom obložene tablete mogu se zdrobiti i uzeti posipanjem cijele doze na meku hranu kao što je jogurt ili jabučna kaša (pire od jabuke).
An interaction between deferasirox and other CYP2C8 substrates like paclitaxel cannot be excluded. 
Ne može se isključiti interakcija između deferasiroksa i drugih supstrata CYP2C8 kao što je paklitaksel.
Clinical study in patients with non-transfusion-dependent thalassaemia syndromes 
Kliničko ispitivanje u bolesnika sa sindromima talasemije neovisnim o transfuziji
Deferasirox metabolism depends on UGT enzymes. 
Metabolizam deferasiroksa ovisi o UGT-enzimima.
Serum creatinine at Day - X 
Prije početka liječenja Serumski kreatinin na dan - X
In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 7 mg/kg. 
U bolesnika u kojih LIC nije utvrđen i serumski feritin je ≤ 2000 µg/l, doziranje ne smije prelaziti 7 mg/kg.
Serum ferritin 
Serumski feritin
Maximum dose 14 mg/kg/day 7 mg/kg/day 
Maksimalna doza 14 mg/kg/dan 7 mg/kg/dan
For patients in whom the dose was increased to >7 mg/kg, dose reduction to 7 mg/kg or less is recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l. 
U bolesnika u kojih je doza povećana na > 7 mg/kg, preporučuje se smanjenje doze na 7 mg/kg ili manje kad je LIC < 7 mg Fe/g težine suhog tkiva jetre ili je serumski feritin ≤ 2000 µg/l.
Other medicines and Deferasirox Mylan 
Drugi lijekovi i Deferasiroks Mylan
Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years and in the elderly. 
Proljev je češće prijavljen u pedijatrijskih bolesnika u dobi od 2 do 5 godina i u starijih bolesnika.
For patients who are unable to swallow whole tablets, the film-coated tablets may be crushed and administered by sprinkling the full dose onto soft food, e.g. yogurt or apple sauce (pureed apple). 
Za bolesnike koji ne mogu progutati cijele tablete, filmom obložene tablete mogu se zdrobiti i primijeniti posipanjem cijele doze na meku hranu, npr. jogurt ili jabučnu kašu (pire od jabuke).
Daily treatment with the deferasirox dispersible tablet formulation at doses of 20 and 30 mg/kg for one year in frequently transfused adult and paediatric patients with beta-thalassaemia led to reductions in indicators of total body iron; liver iron concentration was reduced by about −0.4 and −8.9 mg Fe/g liver (biopsy dry weight (dw)) on average, respectively, and serum ferritin was reduced by about −36 and −926 µg/l on average, respectively. 
Dnevno liječenje deferasiroksom u formulaciji tablete za oralnu suspenziju u dozama od 20 i 30 mg/kg tijekom jedne godine u odraslih i pedijatrijskih bolesnika s beta-talasemijom koji su često primali transfuzije dovelo je do smanjenja pokazatelja ukupnog željeza u tijelu; koncentracija željeza u jetri smanjila se prosječno za −0,4, odnosno za −8,9 mg Fe/g jetre (suha težina (st) biopsijskog materijala), a serumski feritin smanjio se u prosjeku za −36, odnosno za −926 µg/l.
The majority of these patients had renal impairment, renal tubulopathy (Fanconi syndrome) or diarrhoea, or conditions where acid-base imbalance is a known complication. 
Većina tih bolesnika imala je oštećenje bubrega, bubrežnu tubulopatiju (Fanconijev sindrom) ili proljev, ili stanja kod kojih je acido-bazna neravnoteža poznata komplikacija.
Stevens-Johnson syndrome 
Stevens-Johnsonov sindrom 1, hipersenzitivni vaskulitis
• The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as: 
- potreba za tabličnim prikazom vrijednosti serumskog kreatinina, klirensa kreatinina, proteinurije, jetrenih enzima, feritina, izmjerenih prije početka liječenja, npr.:
There have been post-marketing reports of leukopenia, thrombocytopenia or pancytopenia (or aggravation of these cytopenias) and of aggravated anaemia in patients treated with deferasirox. 
Nakon stavljanja lijeka u promet bili su prijavljeni slučajevi leukopenije, trombocitopenije ili pancitopenije (ili pogoršanja tih citopenija) i pogoršanja anemije u bolesnika liječenih deferasiroksom.
<7 ml/kg/month of PRBC (approx. <2 units/month for an adult) 
< 7 ml/kg/mjesec KE-a (otprilike < 2 jedinice/ mjesec za odraslu osobu)
In a healthy volunteer study, the concomitant administration of deferasirox dispersible tablets and midazolam (a CYP3A4 probe substrate) resulted in a decrease of midazolam exposure by 17% (90% CI: 8% - 26%). 
U ispitivanju na zdravim dobrovoljcima, istodobna primjena deferasiroks tableta za oralnu suspenziju i midazolama (test supstrat za CYP3A4) rezultirala je smanjenjem izloženosti midazolamu za 17% (90% CI: 8% - 26%).
Deferasirox is an orally active chelator that is highly selective for iron(III). 
Deferasiroks je visoko selektivan kelator za željezo (III), djelotvoran pri peroralnoj primjeni.
On average, serum ferritin decreased by 222.0 µg/l in patients treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 115 µg/l in patients treated with placebo (p<0.001). 
Serumski feritin u prosjeku se snizio za 222,0 µg/l u bolesnika liječenih deferasiroks tabletama za oralnu suspenziju (početna doza 10 mg/kg/dan) dok se u bolesnika koji su primali placebo (p<0,001) povisio za 115 µg/l.
Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males. 
U žena je prividni klirens deferasiroksa umjereno niži (za 17,5%) nego u muškaraca.
Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with Deferasirox Mylan. 
Bubrežna tubulopatija prijavljena je uglavnom u djece i adolescenata s beta-talasemijom liječenih lijekom Deferasiroks Mylan.
If only very poor haemosiderosis control is achieved at doses up to 21 mg/kg, a further increase (to a maximum of 28 mg/kg) may not achieve satisfactory control, and alternative treatment options may be considered. 
Ako je pri dozama do 21 mg/kg postignuta vrlo slaba kontrola hemosideroze, moguće je da se zadovoljavajuća kontrola neće postići ni daljnjim povećanjem doze (na najviše 28 mg/kg) pa je u tom slučaju potrebno razmotriti druge mogućnosti liječenja.
Blood creatinine increased 
povišen kreatinin u krvi
Interaction with repaglinide and other agents metabolised by CYP2C8 
Interakcija s repaglinidom i drugim lijekovima koji se metaboliziraju putem CYP2C8
Deferasirox Mylan is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2). 
Deferasiroks Mylan se ne preporučuje bolesnicima s teškim oštećenjem jetre (Child Pugh stadij C) (vidjeti dio 5.2).
Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC03 
FARMAKOLOŠKA SVOJSTVA 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: kelatori željeza, ATK oznaka: V03AC03 Mehanizam djelovanja
Treatment with Deferasirox Mylan should be initiated and maintained by physicians experienced in the treatment of chronic iron overload. 
Liječenje lijekom Deferasiroks Mylan mora započeti i nadzirati liječnik iskusan u liječenju kroničnog preopterećenja željezom.
In patients treated with doses >21 mg/kg/day - When target is reached 
U bolesnika liječenih dozama > 21 mg/kg/dan
The pharmacokinetics of deferasirox have not been studied in patients with renal impairment. 
Farmakokinetika deferasiroksa nije ispitivana u bolesnika s oštećenjem bubrega.
Chelation therapy should only be initiated when there is evidence of iron overload (liver iron concentration [LIC] ≥5 mg Fe/g dry weight [dw] or serum ferritin consistently >800 µg/l). 
Kelacijska se terapija započinje kad postoji dokaz preopterećenja željezom (koncentracija željeza u jetri [engl. liver iron concentration, LIC] ≥ 5 mg Fe/g težine suhog tkiva jetre ili serumskog feritina dosljedno > 800 µg/l).
Alternative starting doses 
Druge moguće početne doze
In patients treated with doses greater than 21 mg/kg, dose reductions in steps of 3.5 to 7 mg/kg should be considered when control has been achieved (e.g. serum ferritin levels persistently below 2,500 µg/l and showing a decreasing trend over time). 
U bolesnika liječenih dozama većim od 21 mg/kg treba razmotriti snižavanje doze u koracima od 3,5 do 7 mg/kg u slučaju kada je postignuta kontrola (npr. razine feritina u serumu su stalno ispod 2500 µg/l i pokazuju trend opadanja tijekom vremena).
In a 1-year study in patients with non-transfusion-dependent thalassaemia syndromes and iron overload (dispersible tablets at a dose of 10 mg/kg/day), diarrhoea (9.1%), rash (9.1%), and nausea (7.3%) were the most frequent study drug-related adverse events. 
U jednogodišnjem ispitivanju u bolesnika sa sindromima talasemije neovisnim o transfuziji i s preopterećenjem željezom (tablete za oralnu suspenziju u dozi od 10 mg/kg/dan), najčešći štetni događaji povezani s ispitivanim lijekom bili su proljev (9,1%), osip (9,1%) i mučnina (7,3%).
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 Deferasirox Mylan must be used with caution in such patients. 
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).
Deferasirox Mylan is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups: - in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years, - in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older, - in adult and paediatric patients with other anaemias aged 2 years and older. 
Deferasiroks Mylan je također indiciran za liječenje kroničnog preopterećenja željezom zbog transfuzija krvi kada je terapija deferoksaminom kontraindicirana ili neodgovarajuća u sljedećim skupinama bolesnika: - pedijatrijski bolesnici s beta-talasemijom major i preopterećenjem željezom zbog učestalih transfuzija krvi (≥ 7 ml/kg/mjesec koncentrata eritrocita) u dobi od 2 do 5 godina, - odrasli i pedijatrijski bolesnici s beta-talasemijom major i preopterećenjem željezom zbog neučestalih transfuzija krvi (< 7 ml/kg/mjesec koncentrata eritrocita) u dobi od 2 godine i stariji, - odrasli i pedijatrijski bolesnici s drugim vrstama anemija u dobi od 2 godine i stariji.
In an iron-balance metabolic study in iron-overloaded adult thalassaemic patients, deferasirox at daily doses of 10, 20 and 40 mg/kg (dispersible tablet formulation) induced the mean net excretion of 0.119, 0.329 and 0.445 mg Fe/kg body weight/day, respectively. 
U ispitivanju metaboličke ravnoteže željeza u odraslih bolesnika s talasemijom i preopterećenjem željezom srednja vrijednost neto izlučenog željeza pri dnevnim dozama deferasiroksa od 10, 20, odnosno 40 mg/kg (formulacija tablete za oralnu suspenziju) iznosila je 0,119, 0,329, odnosno 0,445 mg Fe/kg tjelesne težine/dan.
Caution should be taken during chelation therapy to minimise the risk of over-chelation in all patients (see section 4.4). 
Nužan je oprez tijekom kelacijske terapije kako bi se rizik od prekomjerne kelacije sveo na najmanju moguću mjeru u svih bolesnika (vidjeti dio 4.4).
Early signs of acute overdose are digestive effects such as abdominal pain, diarrhoea, nausea and vomiting. 
Rani znakovi akutnog predoziranja manifestiraju se učincima na probavni sustav poput boli u abdomenu, proljeva, mučnine i povraćanja.
Serum creatinine 
Serumski kreatinin
An initial daily dose of 7 mg/kg may be considered for patients who do not require reduction of body iron levels and who are also receiving less than 7 ml/kg/month of packed red blood cells (approximately <2 units/month for an adult). 
Početna dnevna doza od 7 mg/kg može se razmotriti u bolesnika u kojih ne treba snižavati razine željeza u tijelu, a koji također primaju manje od 7 ml/kg/mjesec koncentrata eritrocita (približno < 2 jedinice/mjesec za odraslog).
There have been post-marketing reports of metabolic acidosis. 
Nakon stavljanja lijeka u promet bili su prijavljeni slučajevi metaboličke acidoze.
An initial daily dose of 21 mg/kg may be considered for patients who require reduction of elevated body iron levels and who are also receiving more than 14 ml/kg/month of packed red blood cells (approximately >4 units/month for an adult). 
Početna dnevna doza od 21 mg/kg može se razmotriti u bolesnika u kojih treba sniziti povišene razine željeza u tijelu, a koji također primaju više od 14 ml/kg/mjesec koncentrata eritrocita (približno > 4 jedinice/mjesec za odraslog).
• That rises in serum transaminases may occur in patients treated with Deferasirox Mylan ◦ The need for liver function tests prior to prescription, then at monthly intervals or more often if clinically indicated ◦ Not to prescribe to patients with pre-existing severe hepatic disease ◦ The need to interrupt treatment if persistent and progressive increase in liver enzyme were noted. 
- važnost mjerenja klirensa kreatinina - kratak pregled metoda mjerenja klirensa kreatinina - informacija o tome da u bolesnika liječenih lijekom Deferasiroks Mylan može doći do povišenja serumskih transaminaza ◦ potreba za testovima jetrene funkcije prije propisivanja lijeka, a zatim u mjesečnim razmacima ili češće ako postoji klinička indikacija ◦ da se ne propisuje bolesnicima s prethodnom teškom bolešću jetre ◦ potreba prekida liječenja ako se uoči ustrajno i progresivno povišenje jetrenih enzima. - potreba za godišnjim pregledom sluha i vida
Creatinine clearance in transfusional iron overload 
Klirens kreatinina pri preopterećenju željezom izazvanom transfuzijama
After every 3 to 6 months of treatment, a dose increase in increments of 3.5 to 7 mg/kg should be considered if the patient's LIC is ≥7 mg Fe/g dw, or if serum ferritin is consistently >2,000 µg/l and not showing a downward trend, and the patient is tolerating the medicinal product well. 
Nakon svakih 3 do 6 mjeseci liječenja potrebno je razmotriti mogućnost povećanja doze za 3,5 do 7 mg/kg ako je u bolesnika LIC ≥ 7 mg Fe/g težine suhog tkiva jetre, odnosno ako je serumski feritin dosljedno > 2000 µg/l bez naznaka silaznog trenda, a bolesnik dobro podnosi lijek.
The recommended initial daily dose of Deferasirox Mylan film-coated tablets is 14 mg/kg body weight. 
Preporučena početna dnevna doza Deferasiroks Mylan filmom obloženih tableta je 14 mg/kg tjelesne težine.
When serum creatinine is elevated and if another abnormality has been detected (e.g. proteinuria, signs of Fanconi syndrome). 
◦ potreba da se razmotri biopsija bubrega: kad je serumski kreatinin povišen, a otkrivena je još jedna abnormalnost (npr. proteinurija, znakovi Fanconijeva sindroma).
• Swelling of arms or legs 
- Oticanje ruku ili nogu
In addition, in patients with liver iron concentration ≥7 mg Fe/g dw with various rare anaemias or sickle cell disease, deferasirox dispersible tablets up to 20 and 30 mg/kg produced a decrease in liver iron concentration and serum ferritin comparable to that obtained in patients with beta-thalassaemia. 
Osim toga, u bolesnika s različitim rijetkim anemijama ili s bolešću srpastih stanica koji su imali koncentraciju željeza u jetri ≥ 7 mg Fe/g suhe težine, primjenom deferasiroks tableta za oralnu suspenziju u dozama do 20 i 30 mg/kg postignuto je sniženje koncentracije željeza u jetri i serumskog feritina usporedivo s onim postignutim u bolesnika s beta-talasemijom.
In a healthy volunteer study, the concomitant administration of deferasirox (single dose of 30 mg/kg, dispersible tablet formulation) and the potent UGT inducer, rifampicin, (repeated dose of 600 mg/day) resulted in a decrease of deferasirox exposure by 44% (90% CI: 37% - 51%). 
U ispitivanju na zdravim dobrovoljcima, istodobna primjena deferasiroksa (jednokratna doza od 30 mg/kg, formulacija tablete za oralnu suspenziju) i potentnog UGT induktora, rifampicina (ponovljena doza od 600 mg/dan) dovela je do smanjene izloženosti deferasiroksa za 44% (90% CI: 37% - 51%).
There have been post-marketing reports of metabolic acidosis occurring during treatment with deferasirox. 
Nakon stavljanja lijeka u promet bili su prijavljeni slučajevi metaboličke acidoze koja se javljala tijekom liječenja deferasiroksom.
Interaction with theophylline and other agents metabolised by CYP1A2 
Interakcija s teofilinom i drugim lijekovima koji se metaboliziraju putem CYP1A2
In duplicate prior to therapy. 
Dva puta prije terapije.
All references to the dispersible tablet formulation throughout the SmPC refer to the reference medical product dispersible tablets. 
Sve reference na formulaciju lijeka u obliku tableta za oralnu suspenziju u ovom sažetku opisa svojstava lijeka odnose se na tablete za oralnu suspenziju referentnog lijeka.