natgillin/translations-raw huggingface dataset:
Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with deferasirox. 
Bubrežna tubulopatija prijavljena je uglavnom u djece i adolescenata s beta-talasemijom liječenih deferasiroksom.
For paediatric patients 
Za pedijatrijske bolesnike
Monthly and Monthly 
- Poslije toga mjesečno i mjesečno
If you stop taking Deferasirox Mylan 
Ako prestanete uzimati Deferasiroks Mylan
Non-transfusion-dependent thalassaemia syndromes: 
Sindromi talasemije neovisni o transfuziji:
It is recommended that serum creatinine be assessed in duplicate before initiating therapy. 
Prije početka terapije preporučuje se određivanje serumskog kreatinina u dva navrata.
The pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the upper limit of the normal range. 
Razine jetrenih transaminaza do 5 puta veće od gornje granice normalnog raspona nisu utjecale na farmakokinetiku deferasiroksa.
The transporters MRP2 and MXR (BCRP) are involved in the biliary excretion of deferasirox. 
U izlučivanju deferasiroksa putem žuči sudjeluju prijenosnici MRP2 i MXR (BCRP).
If you miss a dose, take it as soon as you remember on that day. 
Ako ste zaboravili uzeti Deferasiroks Mylan Ako ste propustili uzeti dozu, uzmite ju istog dana čim se sjetite.
Characteristics in patients 
Obilježja u bolesnika
The patient's serum ferritin should be monitored during and after the combination, and the dose of Deferasirox Mylan adjusted if necessary. 
Tijekom i nakon primjene kombinacije potrebno je pratiti serumski feritin u bolesnika te prilagoditi dozu lijeka Deferasiroks Mylan ako je potrebno.
Auditory (decreased hearing) and ocular (lens opacities) disturbances have been reported (see section 4.8). 
Prijavljeni su poremećaji sluha (slabiji sluh) i vida (zamućenja leće) (vidjeti dio 4.8).
Mylan Hungary Kft. Mylan utca 1 
Mylan utca 1
Bioavailability of deferasirox film-coated tablets was 36% greater than that with dispersible tablets. 
Bioraspoloživost deferasiroks filmom obloženih tableta bila je 36% veća od bioraspoloživosti tableta za oralnu suspenziju.
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. 
- 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.
Transfusional iron overload: 
Preopterećenje željezom izazvano transfuzijama:
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). 
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).
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%). 
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%).
Agents that may decrease Deferasirox Mylan systemic exposure 
Lijekovi koji mogu smanjiti sistemsku izloženost lijeku Deferasiroks Mylan
Increase 3.5 - 7 mg/kg/day 
Povećanje 3,5 - 7 mg/kg/dan
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. 
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]).
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. 
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.
Glucuronidation is the main metabolic pathway for deferasirox, with subsequent biliary excretion. 
Glavni metabolički put deferasiroksa je glukuronidacija s posljedičnim izlučivanjem putem žuči.
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. 
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).
Caution should be used in elderly patients due to a higher frequency of adverse reactions (in particular, diarrhoea). 
Oprez je nužan pri primjeni u starijih bolesnika zbog viših učestalosti nuspojava (osobito proljeva).
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). 
Preporučuje se praćenje serumskog feritina jednom mjesečno zbog procjene bolesnikova odgovora na terapiju te radi izbjegavanja prekomjerne kelacije (vidjeti dio 4.2).
Before initiation of therapy 
Prije terapije.
Cases of acute renal failure have been reported following post-marketing use of deferasirox (see section 4.8). 
Nakon stavljanja deferasiroksa u promet prijavljeni su slučajevi akutnog zatajenja bubrega (vidjeti dio 4.8).
What Deferasirox Mylan contains 
Što Deferasiroks Mylan sadrži
• Abnormal level of acid in blood 
- Jaka bol u gornjem dijelu trbuha (pankreatitis) - Nenormalna razina kiseline u krvi
• 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. 
- 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.
No inhibition of deferasirox metabolism by hydroxyurea was observed in vitro. 
In vitro. nije opaženo da bi hidroksiureja inhibirala metabolizam deferasiroksa.
Deferasirox Mylan is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. 
Deferasiroks Mylan je indiciran za liječenje kroničnog preopterećenja željezom zbog čestih transfuzija krvi (≥ 7 ml/kg/mjesec koncentrata eritrocita) u bolesnika s beta-talasemijom major u dobi od 6 godina i starijih.
Exposure was increased 2.8-fold in one subject with severe hepatic impairment (Child-Pugh Class C) (see sections 4.2 and 4.4). 
U jednog ispitanika s teškim oštećenjem jetre (Child-Pugh stadij C), izloženost je bila povećana za 2,8 puta (vidjeti dijelove 4.2 i 4.4).
• The usual daily dose for Deferasirox Mylan film-coated tablets at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight. 
- Uobičajena dnevna doza Deferasiroks Mylan filmom obloženih tableta na početku liječenja za bolesnike koji primaju redovite transfuzije krvi je 14 mg po kilogramu tjelesne težine.
Deferasirox Mylan is also used to treat chronic iron overload when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years. 
Deferasiroks Mylan se također koristi za liječenje kroničnog preopterećenja željezom kada je terapija deferoksaminom kontraindicirana ili neodgovarajuća u bolesnika s beta-talasemijom major s preopterećenjem željezom uzrokovanim rijetkim transfuzijama krvi, u bolesnika s ostalim vrstama anemija te u djece u dobi od 2 do 5 godina.
Deferasirox also comes as “dispersible” tablets. 
Deferasiroks je dostupan i u obliku tableta za „oralnu suspenziju”.
Deferasirox Mylan is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusiondependent thalassaemia syndromes aged 10 years and older. 
Deferasiroks Mylan je također indiciran za liječenje kroničnog preopterećenja željezom koje zahtijeva terapiju kelatorima željeza kad je terapija deferoksaminom kontraindicirana ili neodgovarajuća za bolesnike u dobi od 10 godina i starije sa sindromima talasemije neovisnim o transfuziji.
• If you get reduced hearing, tell your doctor as soon as possible. 
- Ako Vam se zamagli ili zamuti vid, - Ako Vam oslabi sluh, čim prije obavijestite svog liječnika.
Rash, pruritus 
osip, svrbež
The recommended initial daily dose of Deferasirox Mylan film-coated tablets in patients with nontransfusion-dependent thalassaemia syndromes is 7 mg/kg body weight. 
Preporučena početna dnevna doza Deferasiroks Mylan filmom obloženih tableta u bolesnika sa sindromima talasemije neovisnim o transfuziji je 7 mg/kg tjelesne težine.
Post-marketing cases of severe forms of renal tubulopathy (such as Fanconi syndrome) and renal failure associated with changes in consciousness in the context of hyperammonaemic encephalopathy have been reported in patients treated with deferasirox, mainly in children. 
Nakon stavljanja lijeka u promet, u bolesnika liječenih deferasiroksom, uglavnom djece, bili su prijavljeni slučajevi teških oblika bubrežne tubulopatije (kao što je Fanconijev sindrom) te zatajenja bubrega povezani s promjenama svijesti u sklopu hiperamonemične encefalopatije.
≥5 mg Fe/g dw or >800 µg/l 
≥ 5 mg Fe/g težine suhog tkiva jetre ili > 800 µg/l
On average, liver iron concentration decreased by 3.80 mg Fe/g dw in patients treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 0.38 mg Fe/g dw in patients treated with placebo (p<0.001). 
Koncentracija željeza u jetri snizila se u prosjeku za 3,80 mg Fe/g težine suhog tkiva jetre 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) povisila za 0,38 mg Fe/g težine suhog tkiva jetre.
Cardiac function should be monitored in patients with severe iron overload during long-term treatment with Deferasirox Mylan. 
U bolesnika s teškim preopterećenjem željezom potrebno je, pri dugotrajnom liječenju lijekom Deferasiroks Mylan, pratiti funkciju srca.
Deferasirox Mylan 360 mg 
Deferasiroks Mylan 360 mg
Decrease 3.5 - 7 mg/kg/day 
Smanjenje 3,5 - 7 mg/kg/dan
Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)). 
U bolesnika s različitim vrstama anemije (npr. talasemijom, bolešću srpastih stanica ili mijelodisplastičnim sindromima (MDS)) može biti nužno provoditi ponovljene transfuzije krvi.
Deferasirox Mylan 90 mg 
Deferasiroks Mylan 90 mg
It is recommended that serum ferritin be monitored every month to assess the patient's response to therapy and to minimise the risk of overchelation (see section 4.4). 
Preporučuje se pratiti vrijednost serumskog feritina svaki mjesec kako bi se procijenio bolesnikov odgovor na terapiju te rizik od prekomjerne kelacije sveo na najmanju moguću mjeru (vidjeti dio 4.4).
Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulations. 
Deferasiroks filmom obložene tablete pokazuju višu bioraspoloživost u usporedbi s formulacijom lijeka deferasiroks u obliku tableta za oralnu suspenziju.
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Deferasirox Mylan (see section 4.4). 
Uz primjenu lijeka Deferasiroks Mylan prijavljene su teške kožne nuspojave, uključujući StevensJohnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) i reakciju na lijek s eozinofilijom i sistemskim simptomima (DRESS) (vidjeti dio 4.4).
21 mg/kg/day 
21 mg/kg/dan
<7 mg Fe/g dw or ≤2,000 µg/l 
< 7 mg Fe/g težine suhog tkiva jetre ili ≤ 2000 µg/l
How long to take Deferasirox Mylan 
Koliko dugo uzimati Deferasiroks Mylan
Interruption of deferasirox therapy should be considered in patients who develop metabolic acidosis. 
U bolesnika koji razviju metaboličku acidozu mora se razmotriti prekid terapije lijekom deferasiroks.
Deferasirox Mylan 180 mg 
Deferasiroks Mylan 180 mg
Optic neuritis Ear and labyrinth disorders Uncommon: 
optički neuritis Poremećaji uha i labirinta Manje često:
Deferasirox film-coated tablets demonstrate higher bioavailability compared to deferasirox dispersible tablet formulation (see section 5.2). 
Deferasiroks filmom obložene tablete pokazuju višu bioraspoloživost u usporedbi s formulacijom lijeka u obliku tableta za oralnu suspenziju (vidjeti dio 5.2).
Test 
Pretraga
Your eyesight and hearing will be tested each year during treatment as a precautionary measure. 
Kao mjeru opreza, svake ćete godine, sve dok se liječite, kontrolirati vid i sluh.
Uncommon (may affect up to 1 in 100 people) 
Manje česte (mogu se javiti u do 1 na 100 osoba) - Omaglica - Vrućica
The patient information pack should contain: 
Informacijski paket za bolesnike mora sadržavati: - Uputu o lijeku - Vodič za bolesnike
Deferasirox Mylan is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older. 
Deferasiroks Mylan se koristi za liječenje kroničnog preopterećenja željezom uzrokovanog čestim transfuzijama krvi u bolesnika s beta-talasemijom major u dobi od 6 godina i starijih.
As a consequence, treatment with Deferasirox Mylan is not recommended in these patients. 
Kao posljedica toga, u tih se bolesnika ne preporučuje liječenje lijekom Deferasiroks Mylan.
Deferasirox has been studied only in patients with baseline serum creatinine within the ageappropriate normal range. 
Deferasiroks je ispitivan samo u bolesnika čije su vrijednosti kreatinina u serumu na početku liječenja bile unutar granica normalnog raspona odgovarajućeg za dob.
7 mg/kg/day 
7 mg/kg/dan
Postmarketing cases of hepatic failure, sometimes fatal, have been reported in patients treated with deferasirox. 
Nakon stavljanja lijeka u promet prijavljeni su slučajevi zatajenja jetre, od kojih su neki bili fatalni, u bolesnika liječnih deferasiroksom.
Dizziness 
gluhoća
- if you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes 
(znakovi teške alergijske reakcije), - Ako primijetite kombinaciju bilo kojih od sljedećih simptoma: osip, crvenu kožu, mjehuriće na usnicama, očima ili u ustima, ljuštenje kože, vrućicu, simptome nalik gripi, povećane limfne čvorove (znakovi teških kožnih reakcija), - Ako primijetite izrazito smanjenje izlučivanja mokraće (znak bubrežnog problema), - Ako osjetite kombinaciju omamljenosti, bolova u gornjem desnom dijelu trbuha, požutite ili
Creatinine clearance 
Klirens kreatinina
Deferasirox Mylan 360 mg film-coated tablets are also available in blister pack of 300 tablets. 
Deferasiroks Mylan 360 mg filmom obložene tablete dostupne su i u blisterima s 300 tableta.
≥7 mg Fe/g dw or >2,000 µg/l 
≥ 7 mg Fe/g težine suhog tkiva jetre ili > 2000 µg/l
In a retrospective meta-analysis of 2,102 adult and paediatric beta-thalassaemia patients with transfusional iron overload treated with deferasirox dispersible tablets in two randomised and four open label studies of up to five years' duration, a mean creatinine clearance decrease of 13.2% in adult patients (95% CI: −14.4% to −12.1%; n=935) and 9.9% (95% CI: −11.1% to −8.6%; n=1,142) in paediatric patients was observed during the first year of treatment. 
U retrospektivnoj meta-analizi 2102 odrasla i pedijatrijska bolesnika s beta-talasemijom s preopterećenjem željezom izazvanim transfuzijama koji su liječeni deferasiroks tabletama za oralnu suspenziju u dva randomizirana i četiri otvorena ispitivanja u trajanju do pet godina, zapažena je srednja vrijednost smanjenja klirensa kreatinina od 13,2% u odraslih bolesnika (95% CI: −14,4% do
A food-effect study involving administration of the film-coated tablets to healthy volunteers under fasting conditions and with a low-fat (fat content <10% of calories) or high-fat (fat content >50% of calories) meal indicated that the AUC and Cmax were slightly decreased after a low-fat meal (by 11% and 16%, respectively). 
Ispitivanje učinka hrane koje je uključivalo primjenu filmom obloženih tableta u zdravih dobrovoljaca natašte te uz nemasni (sadržaj masti < 10% kalorija) ili punomasni (sadržaj masti > 50% kalorija)
Eye disorders Uncommon: 
Poremećaji oka Manje često:
1, thrombocytopenia 
1, trombocitopenija
Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets 
Deferasiroks Mylan 90 mg filmom obložene tablete Deferasiroks Mylan 180 mg filmom obložene tablete Deferasiroks Mylan 360 mg filmom obložene tablete
Hypromellose Titanium dioxide (E171) Macrogol/PEG (6000) Talc 
hipromeloza titanijev dioksid (E171) makrogol/PEG (6000) talk željezov oksid, žuti (E172) željezov oksid, crveni (E172)
<3 mg Fe/g dw or <300 µg/l 
< 3 mg Fe/g težine suhog tkiva jetre ili < 300 µg/l
Transfusional iron overload 
Preopterećenje željezom izazvano transfuzijama
Deferasirox Mylan 90 mg film-coated tablets Deferasirox Mylan 180 mg film-coated tablets Deferasirox Mylan 360 mg film-coated tablets deferasirox 
Deferasiroks Mylan 90 mg filmom obložene tablete Deferasiroks Mylan 180 mg filmom obložene tablete Deferasiroks Mylan 360 mg filmom obložene tablete deferasiroks
Skin disorders 
Poremećaji kože
• Description of available deferasirox formulations on the market (e.g. dispersible tablets, filmcoated tablets and granules) ◦ Different posology regimen ◦ Different conditions of administration ◦ Dose conversion table when switching from one formulation to another 
Vodič za zdravstvene radnike mora sadržavati sljedeće ključne elemente: - opis dostupnih formulacija deferasiroksa na tržištu (npr. tablete za oralnu suspenziju, filmom obložene tablete i granule) ◦ različiti režimi doziranja ◦ različiti uvjeti primjene ◦ tablica za preračunavanje doze kod prelaska s jedne formulacije lijeka na drugu - preporučene doze i pravila za početak liječenja - potreba mjesečnog praćenja serumskog feritina
Upper gastrointestinal ulceration and haemorrhage have been reported in patients, including children and adolescents, receiving deferasirox. 
U bolesnika koji primaju deferasiroks, uključujući djecu i adolescente, prijavljene su ulceracije i krvarenja u gornjem dijelu gastrointestinalnog trakta.
Deferasirox Mylan is also used when deferoxamine therapy is contraindicated or inadequate to treat patients aged 10 years or older who have iron overload associated with their thalassaemia syndromes, but who are not transfusion dependent. 
Deferasiroks Mylan se također koristi za liječenje bolesnika u dobi od 10 godina ili starijih u kojih je došlo do preopterećenja željezom povezanog sa sindromima talasemije neovisnim o transfuziji.
Each film-coated tablet contains 360 mg deferasirox 
Jedna filmom obložena tableta sadrži 360 mg deferasiroksa
Each film-coated tablet contains 90 mg deferasirox. 
Jedna filmom obložena tableta sadrži 90 mg deferasiroksa.
Breast-feeding while taking Deferasirox Mylan is not recommended. 
Tijekom primjene lijeka Deferasiroks Mylan ne preporučuje se dojenje.
Skin rashes may appear during Deferasirox Mylan treatment. 
Tijekom liječenja lijekom Deferasiroks Mylan moguća je pojava kožnih osipa.
How to take Deferasirox Mylan 
Kako uzimati Deferasiroks Mylan
Adverse reactions reported during post-marketing experience. 
Nuspojave prijavljene nakon stavljanja lijeka u promet.
What Deferasirox Mylan is 
Što je Deferasiroks Mylan
• Each film-coated tablet of Deferasirox Mylan 360 mg contains 360 mg deferasirox. 
- Svaka Deferasiroks Mylan 360 mg filmom obložena tableta sadrži 360 mg deferasiroksa.
Monitoring your Deferasirox Mylan treatment 
Praćenje liječenja lijekom Deferasiroks Mylan
Each film-coated tablet contains 180 mg deferasirox 
Jedna filmom obložena tableta sadrži 180 mg deferasiroksa
> age appropriate ULN 
> GGN-a prikladnog za godine i/ili smanjen < DGN-a
• Each film-coated tablet of Deferasirox Mylan 90 mg contains 90 mg deferasirox. 
- Svaka Deferasiroks Mylan 90 mg filmom obložena tableta sadrži 90 mg deferasiroksa.
Medicines called iron chelators are used to remove the excess iron and reduce the risk of it causing organ damage. 
Da bi se uklonio višak željeza i smanjio rizik od oštećenja organa, koriste se lijekovi koji se nazivaju kelatorima željeza.
• Each film-coated tablet of Deferasirox Mylan 180 mg contains 180 mg deferasirox. 
- Svaka Deferasiroks Mylan 180 mg filmom obložena tableta sadrži 180 mg deferasiroksa.
Deferasirox Mylan 180 mg film-coated tablets 
Deferasiroks Mylan 180 mg filmom obložene tablete
Deafness Respiratory, thoracic and mediastinal disorders Uncommon: 
Poremećaji dišnog sustava, prsišta i sredoprsja Manje često:
Non-transfusion-dependent thalassaemia syndromes 
Sindromi talasemije neovisni o transfuziji
• The importance of measuring creatinine clearance • Brief overview of methods of measuring creatinine clearance 
Edukacijski materijal za liječnike mora sadržavati: - Sažetak opisa svojstava lijeka - Vodič za zdravstvene radnike
90 film-coated tablets 300 film-coated tablets 
90 filmom obloženih tableta 300 filmom obloženih tableta
How to store Deferasirox Mylan 
Kako čuvati Deferasiroks Mylan
A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 1' on the other side. 
Bikonveksna filmom obložena tableta modificiranog oblika kapsule, boje breskve, s utisnutom oznakom „ ” na jednoj strani tablete i „DF 1” na drugoj strani.
A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF 2' on the other side. 
Bikonveksna filmom obložena tableta modificiranog oblika kapsule, boje breskve, s utisnutom oznakom „ ” na jednoj strani tablete i „DF 2” na drugoj strani.
Deferasirox Mylan 360 mg film-coated tablets 
Deferasiroks Mylan 360 mg filmom obložene tablete
Deferasirox Mylan 90 mg film-coated tablets 
Deferasiroks Mylan 90 mg filmom obložene tablete
30 film-coated tablets 90 film-coated tablets 
30 filmom obloženih tableta 90 filmom obloženih tableta
Liver function test elevations have been observed in patients treated with deferasirox. 
U bolesnika liječenih deferasiroksom opažena su povišenja vrijednosti testova jetrene funkcije.
A peach, film-coated, modified capsule shaped, biconvex tablet debossed with “ ” on one side of the tablet and ‘DF' on the other side. 
Bikonveksna filmom obložena tableta modificiranog oblika kapsule, boje breskve, s utisnutom oznakom „ ” na jednoj strani tablete i „DF” na drugoj strani.
6 months) 
6.3 Rok valjanosti
Very common (may affect more than 1 in 10 people) 
Vrlo česte (mogu se javiti u više od 1 na 10 osoba) - Poremećaj testova funkcije bubrega.