natgillin/translations-raw huggingface dataset:
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.
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.