FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: The majority of these patients had renal impairment, renal tubulopathy (Fanconi syndrome) or diarrhoea, or conditions where acid-base imbalance is a known complication.
Croatian: Većina tih bolesnika imala je oštećenje bubrega, bubrežnu tubulopatiju (Fanconijev sindrom) ili proljev, ili stanja kod kojih je acido-bazna neravnoteža poznata komplikacija.
English: Stevens-Johnson syndrome
Croatian: Stevens-Johnsonov sindrom 1, hipersenzitivni vaskulitis
English: • The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as:
Croatian: - potreba za tabličnim prikazom vrijednosti serumskog kreatinina, klirensa kreatinina, proteinurije, jetrenih enzima, feritina, izmjerenih prije početka liječenja, npr.:
English: 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.
Croatian: Nakon stavljanja lijeka u promet bili su prijavljeni slučajevi leukopenije, trombocitopenije ili pancitopenije (ili pogoršanja tih citopenija) i pogoršanja anemije u bolesnika liječenih deferasiroksom.
English: <7 ml/kg/month of PRBC (approx. <2 units/month for an adult)
Croatian: < 7 ml/kg/mjesec KE-a (otprilike < 2 jedinice/ mjesec za odraslu osobu)
English: 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%).
Croatian: 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%).
English: Deferasirox is an orally active chelator that is highly selective for iron(III).
Croatian: Deferasiroks je visoko selektivan kelator za željezo (III), djelotvoran pri peroralnoj primjeni.
English: 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).
Croatian: 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.
English: Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males.
Croatian: U žena je prividni klirens deferasiroksa umjereno niži (za 17,5%) nego u muškaraca.
English: Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with Deferasirox Mylan.
Croatian: Bubrežna tubulopatija prijavljena je uglavnom u djece i adolescenata s beta-talasemijom liječenih lijekom Deferasiroks Mylan.
English: 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.
Croatian: 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.
English: Blood creatinine increased
Croatian: povišen kreatinin u krvi
English: Interaction with repaglinide and other agents metabolised by CYP2C8
Croatian: Interakcija s repaglinidom i drugim lijekovima koji se metaboliziraju putem CYP2C8
English: Deferasirox Mylan is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2).
Croatian: Deferasiroks Mylan se ne preporučuje bolesnicima s teškim oštećenjem jetre (Child Pugh stadij C) (vidjeti dio 5.2).
English: Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC03
Croatian: FARMAKOLOŠKA SVOJSTVA 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: kelatori željeza, ATK oznaka: V03AC03 Mehanizam djelovanja
English: Treatment with Deferasirox Mylan should be initiated and maintained by physicians experienced in the treatment of chronic iron overload.
Croatian: Liječenje lijekom Deferasiroks Mylan mora započeti i nadzirati liječnik iskusan u liječenju kroničnog preopterećenja željezom.
English: In patients treated with doses >21 mg/kg/day - When target is reached
Croatian: U bolesnika liječenih dozama > 21 mg/kg/dan
English: The pharmacokinetics of deferasirox have not been studied in patients with renal impairment.
Croatian: Farmakokinetika deferasiroksa nije ispitivana u bolesnika s oštećenjem bubrega.
English: 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).
Croatian: 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).
English: Alternative starting doses
Croatian: Druge moguće početne doze
English: 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).
Croatian: 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).
English: 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.
Croatian: 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%).
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 Deferasirox Mylan 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: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Caution should be taken during chelation therapy to minimise the risk of over-chelation in all patients (see section 4.4).
Croatian: 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).
English: Early signs of acute overdose are digestive effects such as abdominal pain, diarrhoea, nausea and vomiting.
Croatian: Rani znakovi akutnog predoziranja manifestiraju se učincima na probavni sustav poput boli u abdomenu, proljeva, mučnine i povraćanja.
English: Serum creatinine
Croatian: Serumski kreatinin
English: 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).
Croatian: 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).
English: There have been post-marketing reports of metabolic acidosis.
Croatian: Nakon stavljanja lijeka u promet bili su prijavljeni slučajevi metaboličke acidoze.
English: 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).
Croatian: 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).
English: • 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.
Croatian: - 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
English: Creatinine clearance in transfusional iron overload
Croatian: Klirens kreatinina pri preopterećenju željezom izazvanom transfuzijama
English: 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.
Croatian: 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.
English: The recommended initial daily dose of Deferasirox Mylan film-coated tablets is 14 mg/kg body weight.
Croatian: Preporučena početna dnevna doza Deferasiroks Mylan filmom obloženih tableta je 14 mg/kg tjelesne težine.
English: When serum creatinine is elevated and if another abnormality has been detected (e.g. proteinuria, signs of Fanconi syndrome).
Croatian: ◦ potreba da se razmotri biopsija bubrega: kad je serumski kreatinin povišen, a otkrivena je još jedna abnormalnost (npr. proteinurija, znakovi Fanconijeva sindroma).
English: • Swelling of arms or legs
Croatian: - Oticanje ruku ili nogu
English: 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.
Croatian: 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.
English: 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%).
Croatian: 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%).
English: There have been post-marketing reports of metabolic acidosis occurring during treatment with deferasirox.
Croatian: Nakon stavljanja lijeka u promet bili su prijavljeni slučajevi metaboličke acidoze koja se javljala tijekom liječenja deferasiroksom.
English: Interaction with theophylline and other agents metabolised by CYP1A2
Croatian: Interakcija s teofilinom i drugim lijekovima koji se metaboliziraju putem CYP1A2
English: In duplicate prior to therapy.
Croatian: Dva puta prije terapije.
English: All references to the dispersible tablet formulation throughout the SmPC refer to the reference medical product dispersible tablets.
Croatian: 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.
English: Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with deferasirox.
Croatian: Bubrežna tubulopatija prijavljena je uglavnom u djece i adolescenata s beta-talasemijom liječenih deferasiroksom.
English: For paediatric patients
Croatian: Za pedijatrijske bolesnike
English: Monthly and Monthly
Croatian: - Poslije toga mjesečno i mjesečno
English: If you stop taking Deferasirox Mylan
Croatian: Ako prestanete uzimati Deferasiroks Mylan
English: Non-transfusion-dependent thalassaemia syndromes:
Croatian: Sindromi talasemije neovisni o transfuziji:
English: It is recommended that serum creatinine be assessed in duplicate before initiating therapy.
Croatian: Prije početka terapije preporučuje se određivanje serumskog kreatinina u dva navrata.
English: The pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the upper limit of the normal range.
Croatian: Razine jetrenih transaminaza do 5 puta veće od gornje granice normalnog raspona nisu utjecale na farmakokinetiku deferasiroksa.
English: The transporters MRP2 and MXR (BCRP) are involved in the biliary excretion of deferasirox.
Croatian: U izlučivanju deferasiroksa putem žuči sudjeluju prijenosnici MRP2 i MXR (BCRP).
English: If you miss a dose, take it as soon as you remember on that day.
Croatian: Ako ste zaboravili uzeti Deferasiroks Mylan Ako ste propustili uzeti dozu, uzmite ju istog dana čim se sjetite.
English: Characteristics in patients
Croatian: Obilježja u bolesnika
English: The patient's serum ferritin should be monitored during and after the combination, and the dose of Deferasirox Mylan adjusted if necessary.
Croatian: Tijekom i nakon primjene kombinacije potrebno je pratiti serumski feritin u bolesnika te prilagoditi dozu lijeka Deferasiroks Mylan ako je potrebno.
English: Auditory (decreased hearing) and ocular (lens opacities) disturbances have been reported (see section 4.8).
Croatian: Prijavljeni su poremećaji sluha (slabiji sluh) i vida (zamućenja leće) (vidjeti dio 4.8).
English: Mylan Hungary Kft. Mylan utca 1
Croatian: Mylan utca 1
English: Bioavailability of deferasirox film-coated tablets was 36% greater than that with dispersible tablets.
Croatian: Bioraspoloživost deferasiroks filmom obloženih tableta bila je 36% veća od bioraspoloživosti tableta za oralnu suspenziju.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: - Periodička izvješća o neškodljivosti lijeka (PSUR-evi) Zahtjevi za podnošenje PSUR-eva za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
English: Transfusional iron overload:
Croatian: Preopterećenje željezom izazvano transfuzijama:
English: During post-marketing experience, hepatic failure, sometimes fatal, has been reported with the deferasirox dispersible tablet formulation, especially in patients with pre-existing liver cirrhosis (see section 4.4).
Croatian: Nakon stavljanja deferasiroksa u formulaciji tablete za oralnu suspenziju u promet prijavljeni su slučajevi zatajenja jetre, ponekad sa smrtnim ishodom, posebno u bolesnika s već postojećom cirozom jetre (vidjeti dio 4.4).
English: In a healthy volunteer study, the concomitant administration of deferasirox as a CYP1A2 inhibitor (repeated dose of 30 mg/kg/day, dispersible tablet formulation) and the CYP1A2 substrate theophylline (single dose of 120 mg) resulted in an increase of theophylline AUC by 84% (90% CI: 73% to 95%).
Croatian: U ispitivanju na zdravim dobrovoljcima, istodobna primjena deferasiroksa kao inhibitora CYP1A2 (ponovljene doze od 30 mg/kg/dan, formulacija tablete za oralnu suspenziju) i supstrata CYP1A2 teofilina (jednokratna doza od 120 mg) rezultirala je povećanjem AUC-a teofilina za 84% (90% CI: 73% do 95%).
English: Agents that may decrease Deferasirox Mylan systemic exposure
Croatian: Lijekovi koji mogu smanjiti sistemsku izloženost lijeku Deferasiroks Mylan
English: Increase 3.5 - 7 mg/kg/day
Croatian: Povećanje 3,5 - 7 mg/kg/dan
English: In a healthy volunteer study, the concomitant administration of deferasirox as a moderate CYP2C8 inhibitor (30 mg/kg daily, dispersible tablet formulation), with repaglinide, a CYP2C8 substrate, given as a single dose of 0.5 mg, increased repaglinide AUC and Cmax about 2.3-fold (90% CI [2.03-2.63]) and 1.6-fold (90% CI [1.42-1.84]), respectively.
Croatian: U ispitivanju na zdravim dobrovoljcima, istodobna primjena deferasiroksa kao umjerenog inhibitora CYP2C8 (30 mg/kg dnevno, formulacija tablete za oralnu suspenziju) s repaglinidom, supstratom CYP2C8, u jednokratnoj dozi od 0,5 mg, povećala je AUC repaglinida za oko 2,3 puta (90% CI [2,03 - 2,63]) i Cmax repaglinida za 1,6 puta (90% CI [1,42 - 1,84]).
English: During clinical studies, increases in serum creatinine of >33% on ≥2 consecutive occasions, sometimes above the upper limit of the normal range, occurred in about 36% of patients.
Croatian: Tijekom kliničkih ispitivanja u otprilike 36% bolesnika dogodila su se povišenja serumskog kreatinina za > 33% kod ≥ 2 uzastopne provjere, katkada i iznad gornje granice normalnog raspona.
English: Glucuronidation is the main metabolic pathway for deferasirox, with subsequent biliary excretion.
Croatian: Glavni metabolički put deferasiroksa je glukuronidacija s posljedičnim izlučivanjem putem žuči.
English: It appeared from a post-hoc analysis of this study that, in the subgroup of patients with liver iron concentration ≥7 mg Fe/g dw treated with deferasirox dispersible tablets (20 and 30 mg/kg) or deferoxamine (35 to ≥50 mg/kg), the non-inferiority criteria were achieved.
Croatian: Post hoc analiza ovog ispitivanja je pokazala da su mjerila neinferiornosti, čini se, bila zadovoljena u podskupini bolesnika s koncentracijom željeza u jetri ≥ 7 mg Fe/g suhe težine liječenih deferasiroks tabletama za oralnu suspenziju (20 i 30 mg/kg) ili deferoksaminom (35 do ≥ 50 mg/kg).
English: Caution should be used in elderly patients due to a higher frequency of adverse reactions (in particular, diarrhoea).
Croatian: Oprez je nužan pri primjeni u starijih bolesnika zbog viših učestalosti nuspojava (osobito proljeva).
English: Monthly monitoring of serum ferritin is recommended in order to assess the patient's response to therapy and to avoid over-chelation (see section 4.2).
Croatian: Preporučuje se praćenje serumskog feritina jednom mjesečno zbog procjene bolesnikova odgovora na terapiju te radi izbjegavanja prekomjerne kelacije (vidjeti dio 4.2).
English: Before initiation of therapy
Croatian: Prije terapije.
English: Cases of acute renal failure have been reported following post-marketing use of deferasirox (see section 4.8).
Croatian: Nakon stavljanja deferasiroksa u promet prijavljeni su slučajevi akutnog zatajenja bubrega (vidjeti dio 4.8).
English: What Deferasirox Mylan contains
Croatian: Što Deferasiroks Mylan sadrži
English: • Abnormal level of acid in blood
Croatian: - Jaka bol u gornjem dijelu trbuha (pankreatitis) - Nenormalna razina kiseline u krvi
English: • The usual daily dose for Deferasirox Mylan film-coated tablets at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Croatian: - Uobičajena dnevna doza Deferasiroks Mylan filmom obloženih tableta na početku liječenja za bolesnike koji ne primaju redovite transfuzije krvi je 7 mg po kilogramu tjelesne težine.
English: No inhibition of deferasirox metabolism by hydroxyurea was observed in vitro.
Croatian: In vitro. nije opaženo da bi hidroksiureja inhibirala metabolizam deferasiroksa.