natgillin/translations-raw huggingface dataset:
- if you experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your blood, which may be associated with liver or renal problems, see also section 4 “Possible side effects”). 
smanjenu pozornost ili svijest ili osjećaj izrazite pospanosti uz nisku razinu energije (znakovi visoke razine amonijaka u Vašoj krvi, što može biti povezano s jetrenim ili bubrežnim tegobama, vidjeti također dio 4. „Moguće nuspojave”).
The other ingredients are lactose monohydrate, crospovidone type A, povidone, sodium laurilsulfate, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate. 
Drugi sastojci su laktoza hidrat, krospovidon tip A, povidon, natrijev laurilsulfat, mikrokristalična celuloza, koloidni bezvodni silicijev dioksid i magnezijev stearat.
Treatment with EXJADE should be initiated and maintained by physicians experienced in the treatment of chronic iron overload. 
Liječenje lijekom EXJADE mora započeti i dalje pratiti liječnik iskusan u liječenju kroničnog preopterećenja željezom.
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) obrok ukazalo je na to da su AUC i Cmax bili blago povišeni nakon nemasnog obroka (za 11% odnosno 16%).
Dose adjustments may be made in steps of 5 to 10 mg/kg and are to be tailored to the individual patient's response and therapeutic goals (maintenance or reduction of iron burden). 
Prilagodbe doze, ako je potrebno, se mogu provoditi u koracima po 5 do 10 mg/kg vodeći računa o individualnom odgovoru bolesnika i terapijskim ciljevima (održavanje ili smanjenje opterećenja željezom).
Skin rashes may appear during EXJADE treatment. 
Tijekom liječenja lijekom EXJADE moguća je pojava kožnih osipa.
After adjustment of the strength, the granules formulation (4 x 90 mg strength) was equivalent to EXJADE dispersible tablets (500 mg strength) with respect to the mean area under the plasma concentration time curve (AUC) under fasting conditions. 
Nakon prilagodbe jačine, formulacija granula (jačina 4 x 90 mg) bila je ekvivalentna EXJADE formulaciji tablete za oralnu suspenziju (jačina 500 mg) s obzirom na srednju površinu ispod krivulje koncentracije u plazmi i vremena (AUC) kada se uzima natašte.
For deferasirox granules, a dose ratio of 3:1 can be considered (i.e. a dose of deferasirox granules that is numerically one third of the deferoxamine dose). 
Za deferasiroks granule može se razmotriti omjer doza 3:1 (tj. doza deferasiroks granula koja iznosi trećinu brojčane vrijednosti doze deferoksamina).
• If you experience frequent heartburn, 
• Ako imate česte žgaravice,
Monitoring your EXJADE treatment 
Praćenje liječenja lijekom EXJADE
Dose adjustments may be made in steps of 3.5 to 7 mg/kg and are to be tailored to the individual patient's response and therapeutic goals (maintenance or reduction of iron burden). 
Prilagodbe doze, ako je potrebno, se mogu provoditi u koracima po 3,5 do 7 mg/kg vodeći računa o individualnom odgovoru bolesnika i terapijskim ciljevima (održavanje ili smanjenje opterećenja željezom).
EXJADE 125 mg, 250 mg and 500 mg dispersible tablets are available in unit packs containing 28, 84 or 252 dispersible tablets. 
EXJADE 125 mg, 250 mg i 500 mg tablete za oralnu suspenziju su dostupne u jediničnim pakiranjima koja sadrže 28, 84 ili 252 tablete za oralnu suspenziju.
- if you notice a marked decrease in your urine output (sign of kidney problem). 
- ako primijetite izrazito smanjenje izlučivanja mokraće (znak bubrežnog problema).
• Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. 
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „Rok valjanosti“/„EXP“.
Doses above 40 mg/kg are not recommended because there is only limited experience with doses above this level. 
Ne preporučuje se primjena doza iznad 40 mg/kg zbog ograničenog iskustva s dozama iznad te razine.
Starting dose 7 mg/kg/day 
Početna doza 7 mg/kg/dan
The availability of long-term efficacy and safety data with EXJADE 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 o dugotrajnoj djelotvornosti i sigurnosti EXJADE tableta za oralnu suspenziju pri dozama iznad 30 mg/kg (264 bolesnika koji su bili praćeni prosječno 1 godinu nakon povećavanja doze).
In case of switching from film-coated tablets/granules to dispersible tablets, the dose of dispersible tablets should be 40% higher than the dose of film-coated tablets/granules, rounded to the nearest whole tablet. 
U slučaju prelaska s filmom obloženih tableta/granula na tablete za oralnu suspenziju, doza tableta za oralnu suspenziju treba biti 40% viša od doze filmom obloženih tableta/granula, zaokruženo na najbližu cijelu tabletu.
It is recommended that serum creatinine be assessed in duplicate before initiating therapy. 
Prije početka terapije preporučuje se određivanje serumskog kreatinina u duplikatu.
98 dispersible tablets. 
98 tableta za oralnu suspenziju.
If you are switching from the dispersible tablets to these granules, you will need an adjustment of the dose. 
Ako prelazite s tableta za oralnu suspenziju na ove granule, bit će Vam potrebna prilagodba doze.
Stevens-Johnson syndrome1, hypersensitivity vasculitis1, urticaria1, erythema multiforme 
Stevens-Johnsonov sindrom 1, hipersenzitivni vaskulitis
Doses above 20 mg/kg are not recommended because there is no experience with doses above this level in patients with non-transfusion-dependent thalassaemia syndromes. 
Doze iznad 20 mg/kg ne preporučuju se zbog toga što nema iskustva s dozama iznad te razine u bolesnika sa sindromima talasemije neovisnim o transfuziji.
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.
• Adults and Paediatrics: remain >33% above baseline or creatinine clearance <LLN (90 ml/min) 
• odrasli i pedijatrijski bolesnici: ostaje >33% iznad početne vrijednosti ili klirens kreatinina <DGN (90 ml/min)
Half of deferoxamine dose 
Polovica doze deferoksamina
When to take EXJADE 
Kada uzimati EXJADE
The most frequent reactions reported during chronic treatment with deferasirox dispersible tablets in adult and paediatric patients include gastrointestinal disturbances (mainly nausea, vomiting, diarrhoea or abdominal pain) and skin rash. 
Najčešće prijavljene reakcije tijekom kroničnog liječenja deferasiroks tabletama za oralnu suspenziju u odraslih i u pedijatrijskih bolesnika uključuju gastrointestinalne tegobe (uglavnom mučnina, povraćanje, proljev ili bol u trbuhu) i kožni osip.
EXJADE is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older. 
EXJADE 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.
Creatinine clearance and/or plasma cystatin C 
Klirens kreatinina i/ili cistatin C u plazmi Prije terapije.
No inhibition of deferasirox metabolism by hydroxyurea was observed in vitro. 
In vitro nije opaženo da bi hidroksiureja inhibirala metabolizam deferasiroksa.
EXJADE 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. 
EXJADE 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.
EXJADE is supplied as dispersible tablets. 
EXJADE se isporučuje u obliku tableta za oralnu suspenziju.
• EXJADE 360 mg film-coated tablets are dark blue and stamped “360” on one side and “NVR” 
• EXJADE 360 mg filmom obložene tablete su tamno plave i na jednoj strani imaju otisnutu oznaku „360“, a na drugoj strani „NVR“.
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 lifethreatening 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.
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 teofilina za 84% (90% CI: 73% do 95%).
84 dispersible tablets 
84 tablete za oralnu suspenziju
EXJADE 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. 
EXJADE 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.
EXJADE granules should be taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple). 
EXJADE granule trebaju se uzeti posipanjem cijele doze na meku hranu kao što je jogurt ili jabučna kaša (pire od jabuke).
- if you experience frequent abdominal pain, particularly after eating or taking EXJADE. 
- ako imate česte bolove u trbuhu, posebno nakon jela ili uzimanja lijeka EXJADE. - ako imate česte žgaravice.
5-10 mg/kg/day Up to 40 mg/kg/day Decrease 3.5 - 7 mg/kg/day 5-10 mg/kg/day 
5-10 mg/kg/dan Do 40 mg/kg/dan Smanjenje 3,5 - 7 mg/kg/dan 5-10 mg/kg/dan
Deferasirox has been studied only in patients with baseline serum creatinine within the age-appropriate 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.
30 film-coated tablets 90 film-coated tablets 
Filmom obložene tablete 30 filmom obloženih tableta 90 filmom obloženih tableta
Cardiac function should be monitored in patients with severe iron overload during long-term treatment with EXJADE. 
U bolesnika s teškim preopterećenjem željezom potrebno je, pri dugotrajnom liječenju lijekom EXJADE, pratiti funkciju srca.
Bioavailability of deferasirox granules was 52% greater than that with dispersible tablets. 
Bioraspoloživost deferasiroks granula bila je 52% veća od bioraspoloživosti tableta za oralnu suspenziju.
Prior to therapy. 
Prije terapije.
>33% above pretreatment average and Decreases <LLN* (<90 ml/min) 
> 33% iznad prosjeka prije liječenja i smanjen <DGN-a* (<90 ml/min)
Clinical study in patients with non-transfusion-dependent thalassaemia syndromes 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%).
The other ingredients are microcrystalline cellulose; crospovidone; povidone; magnesium stearate; colloidal anhydrous silica and poloxamer. 
Drugi sastojci su mikrokristalična celuloza, krospovidon, povidon, magnezijev stearat, koloidni bezvodni silicijev dioksid i poloksamer.
• Do not use this medicine after the expiry date which is stated on the sachet and the carton after EXP. 
• Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vrećici i kutiji iza oznake „Rok valjanosti“/„EXP“.
• EXJADE 90 mg film-coated tablets are light blue and stamped “90” on one side and “NVR” on the other. 
• EXJADE 90 mg filmom obložene tablete su svijetlo plave i na jednoj strani imaju otisnutu oznaku „90“, a na drugoj strani „NVR“.
Lactose content The dispersible tablets contain lactose. 
Svaka tableta za oralnu suspenziju sadrži laktozu.
The availability of long-term efficacy and safety data from clinical studies conducted with EXJADE 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 EXJADE tableta za oralnu suspenziju pri dozama iznad 30 mg/kg (264 bolesnika koji su bili praćeni prosječno 1 godinu nakon povećavanja doze).
If no satisfactory control is achieved at doses above 30 mg/kg, treatment at such doses should not be maintained and alternative treatment options should be considered whenever possible. 
Ako se pri dozama iznad 30 mg/kg ne postiže zadovoljavajuća kontrola, liječenje takvim dozama se ne treba nastaviti i potrebno je razmotriti druge mogućnosti liječenja kad god je to moguće.
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).
If you are switching from the film-coated tablets or granules to these dispersible tablets, you will need an adjustment of the dose. 
Ako prelazite s filmom obloženih tableta ili granula na ove tablete za oralnu suspenziju, bit će Vam potrebna prilagodba doze.
or >1,000 µg/l 
KE-a ili >1000 µg/l
How to take EXJADE 
Kako uzimati EXJADE
EXJADE is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta thalassaemia major aged 6 years and older. 
EXJADE se koristi za liječenje kroničnog preopterećenja željezom uzrokovanog čestim transfuzijama krvi u bolesnika s beta-talasemijom major u dobi od 6 godina i starijih.
Deferasirox also comes as “dispersible” tablets. 
Deferasiroks je dostupan i u obliku tableta za „oralnu suspenziju“.
• 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.: Prije početka liječenja Serumski kreatinin na dan - X
In case of switching from dispersible tablets to granules, the dose of the granules should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole sachet. 
U slučaju prelaska s tableta za oralnu suspenziju na granule, doza granula treba biti 30% manja od doze tableta za oralnu suspenziju, zaokruženo na najbližu cijelu vrećicu.
Approximate tablet dimensions 17 mm x 6.7 mm. 
Približne dimenzije tablete 17 mm x 6,7 mm.
• Adults: >33% above baseline and creatinine clearance <LLN (90 ml/min) 
• odrasli bolesnici: >33% iznad početne vrijednosti i klirens kreatinina <DGN (90 ml/min)
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.
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.
PVC/PVDC/Aluminium blisters. 
6.5 Vrsta i sadržaj spremnika PVC/PVDC/aluminij blisteri.
• Patient guide 
• Vodič za bolesnike
PVC/PE/PVDC/Aluminium blisters. 
6.5 Vrsta i sadržaj spremnika PVC/PE/PVDC/ aluminij blisteri.
Test 
Pretrage
EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2). 
EXJADE filmom obložene tablete pokazuju višu bioraspoloživost u usporedbi s formulacijom lijeka EXJADE u obliku tableta za oralnu suspenziju (vidjeti dio 5.2).
The multipacks contain 300 (10 packs of 30) film-coated tablets. 
Višestruko pakiranje sadrži 300 (10 pakiranja od 30) filmom obloženih tableta.
The granules should be administered by sprinkling the full dose onto soft food, e.g. yogurt or apple sauce (pureed apple). 
Granule treba primijeniti posipanjem cijele doze na meku hranu, npr. jogurt ili jabučnu kašu (pire od jabuke).
Titanium dioxide (E171) Macrogol (4000) 
Ovojnica: hipromeloza titanijev dioksid (E171) makrogol (4000) talk indigo carmine aluminium lake (E132)
EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2). 
EXJADE granule pokazuju višu bioraspoloživost u usporedbi s formulacijom lijeka EXJADE u obliku tableta za oralnu suspenziju (vidjeti dio 5.2).
In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not exceed 10 mg/kg. 
U pedijatrijskih bolesnika sa sindromima talasemije neovisnim o transfuziji doza ne smije prelaziti 10 mg/kg.
EXJADE 125 mg dispersible tablets EXJADE 250 mg dispersible tablets EXJADE 500 mg dispersible tablets 
EXJADE 125 mg tablete za oralnu suspenziju EXJADE 250 mg tablete za oralnu suspenziju EXJADE 500 mg tablete za oralnu suspenziju
Approximate tablet dimensions 14 mm x 5.5 mm. 
Približne dimenzije tablete 14 mm x 5,5 mm.
EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets 
EXJADE 90 mg filmom obložene tablete EXJADE 180 mg filmom obložene tablete EXJADE 360 mg filmom obložene tablete
In patients treated with doses greater than 30 mg/kg, dose reductions in steps of 5 to 10 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 30 mg/kg treba razmotriti snižavanje doze u koracima od 5 do 10 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 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%). 
Interakcija s midazolamom i drugim lijekovima koji se metaboliziraju putem CYP3A4 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%).
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 EXJADE (see section 4.4). 
Uz primjenu lijeka EXJADE prijavljene su teške kožne nuspojave, uključujući Stevens-Johnsonov sindrom (SJS), toksičnu epidermalnu nekrolizu (TEN) i reakciju na lijek s eozinofilijom i sistemskim simptomima (DRESS) (vidjeti dio 4.4).
In patients whose serum ferritin level has reached the target (usually between 500 and 1,000 µg/l), dose reductions in steps of 5 to 10 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 5 do 10 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.
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. 
Interakcija s repaglinidom i drugim lijekovima koji se metaboliziraju putem CYP2C8 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]).
28 dispersible tablets 
28 tableta za oralnu suspenziju
Interruption of EXJADE therapy should be considered in patients who develop metabolic acidosis. 
U bolesnika koji razviju metaboličku acidozu mora se razmotriti prekid terapije lijekom EXJADE.
In patients in whom LIC was not assessed and serum ferritin is ≤2,000 µg/l, dosing should not exceed 10 mg/kg. 
U bolesnika u kojih LIC nije utvrđen i serumski feritin je ≤2000 µg/l, doziranje ne smije prelaziti10 mg/kg.
For patients in whom the dose was increased to >10 mg/kg, dose reduction to 10 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 >10 mg/kg, preporučuje se smanjenje doze na 10 mg/kg ili manje kad je LIC <7 mg Fe/g težine suhog tkiva jetre ili je serumski feritin ≤2000 µg/l.
In patients not adequately controlled with doses of 21 mg/kg (e.g. serum ferritin levels persistently above 2,500 µg/l and not showing a decreasing trend over time), doses of up to 28 mg/kg may be considered. 
U bolesnika neodgovarajuće kontroliranih dozama od 21 mg/kg (tj. razine feritina u serumu su stalno iznad 2500 µg/l i ne pokazuju trend opadanja tijekom vremena) može se razmotriti primjena doza do 28 mg/kg.