natgillin/translations-raw huggingface dataset:
EXJADE 125 mg dispersible tablets EXJADE 250 mg dispersible tablets EXJADE 500 mg dispersible tablets 
EXJADE 125 mg disperzibilne tablete EXJADE 250 mg disperzibilne tablete EXJADE 500 mg disperzibilne tablete
If you are switching from the dispersible tablets to these granules, you will need an adjustment of the dose. 
Če prehajate z uporabe disperzibilnih tablet na uporabo zrnc, vam bo treba prilagoditi odmerek zdravila.
Unit packs containing 30 sachets. 
Eno pakiranje vsebuje 30 vrečic.
EXJADE is supplied as dispersible tablets. 
Zdravilo EXJADE je na voljo v obliki disperzibilnih tablet.
EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets 
EXJADE 90 mg filmsko obložene tablete EXJADE 180 mg filmsko obložene tablete EXJADE 360 mg filmsko obložene tablete
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. 
Če bolnik pri zdravljenju z odmerki nad 30 mg/kg ni zadovoljivo urejen, ne sme vztrajati pri zdravljenju s takimi odmerki, ampak je treba, kadar je le mogoče, pretehtati možnosti drugih načinov zdravljenja.
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. 
Pri bolnikih, pri katerih je koncentracija feritina dosegla ciljno vrednost (običajno med 500 in 1.000 µg/l), je treba razmisliti o postopnem zniževanju odmerka v korakih po 5 do 10 mg/kg, da bi koncentracijo feritina v serumu lahko obdržali v okviru ciljnih vrednosti in čim bolj zmanjšali tveganje za prekomerno kelacijo.
Breast-feeding while taking EXJADE is not recommended. 
Dojenje v času jemanja zdravila EXJADE ni priporočljivo.
Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)). 
Bolniki z različnimi vrstami slabokrvnosti (npr. s talasemijo, z boleznijo srpastih celic ali z mielodisplastičnim sindromom - MDS), lahko potrebujejo večkratne transfuzije krvi.
What EXJADE is 
Kaj je zdravilo EXJADE
EXJADE film-coated tablets demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation. 
Zdravilo EXJADE filmsko obložene tablete imajo večjo biološko uporabnost v primerjavi z zdravilom EXJADE disperzibilne tablete.
Approximate tablet dimensions 14 mm x 5.5 mm. 
Približna velikost tablete je 14 mm x 5,5 mm.
Approximate tablet dimensions 10.7 mm x 4.2 mm. 
Približna velikost tablete je 10,7 mm x 4,2 mm.
The patient's serum ferritin should be monitored during and after the combination, and the dose of EXJADE adjusted if necessary. 
V obdobju jemanja te kombinacije zdravil in še po njem je treba spremljati bolnikove vrednosti feritina v serumu in po potrebi prilagajati odmerek zdravila EXJADE.
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. 
Poročali so hudih kožnih neželenih reakcijah (SCAR - severe cutaneous adverse reactions), med drugim o Stevens-Johnsonovem sindromu (SJS), toksični epidermalni nekrolizi (TEN) in reakciji na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS - drug reaction with eosinophilia and systemic symptoms), ki so lahko življenjsko nevarni oziroma smrtni.
The bioavailability (AUC) of deferasirox was moderately (approx. 13-25%) elevated when taken 30 minutes before meals with normal or high fat content. 
Če je bil deferasiroks zaužit 30 minut pred obroki z normalno ali visoko vsebnostjo maščob, se je njegova biološka uporabnost (AUC) zmerno (približno 13-25 %) povečala.
EXJADE 125 mg dispersible tablets Packs containing 28, 84 or 252 dispersible tablets. 
EXJADE 125 mg disperzibilne tablete Pakiranje vsebuje 28, 84 ali 252 disperzibilnih tablet.
Approximate tablet dimensions 20 mm x 5.6 mm. 
Približna velikost tablete je 20 mm x 5,6 mm.
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%). 
Medsebojno delovanje s teofilinom in drugimi zdravili, katerih presnova poteka s CYP1A2 V študiji pri zdravih prostovoljcih je sočasna uporaba deferasiroksa kot zaviralca CYP1A2 (v ponavljajočih se odmerkih po 30 mg/kg/dan v obliki disperzibilnih tablet) in substrata CYP1A2 teofilina (v enkratnem odmerku 120 mg) povečala AUC teofilina za 84 % (90-odstotni IZ: 73 % do 95 %).
EXJADE film-coated tablets may be taken either on an empty stomach or with a light meal, preferably at the same time each day (see sections 4.2 and 5.2). 
Filmsko obložene tablete zdravila EXJADE je mogoče jemati bodisi na prazen želodec ali z lahkim obrokom, najbolje vsak dan ob istem času (glejte poglavji 4.2 in 5.2).
Approximate tablet dimensions 12 mm x 3.6 mm. 
Približna velikost tablete je 12 mm x 3,6 mm.
• EXJADE 125 mg tablets are stamped “J 125” on one side and “NVR” on the other. 
• Tablete zdravila EXJADE 125 mg imajo na eni strani vtisnjeno oznako “J 125”, na drugi pa
EXJADE dispersible tablets must be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day (see sections 4.5 and 5.2). 
Disperzibilne tablete EXJADE je treba zaužiti enkrat dnevno na prazen želodec vsaj 30 minut pred obrokom, najbolje vsak dan ob istem času (glejte poglavji 4.5 in 5.2).
EXJADE 250 mg dispersible tablets Packs containing 28, 84 or 252 dispersible tablets. 
EXJADE 250 mg disperzibilne tablete Pakiranje vsebuje 28, 84 ali 252 disperzibilnih tablet.
• Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. 
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vrečici in škatli poleg oznak Uporabno do in EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
When to take EXJADE 
Kdaj jemati zdravilo EXJADE
In case of switching from dispersible tablets to film-coated tablets, the dose of the film-coated tablets should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole tablet. 
V primeru prehoda z disperzibilnih tablet na filmsko obložene tablete, mora biti odmerek pri filmsko obloženih tabletah za 30 % nižji od prejšnjega odmerka v obliki disperzibilnih tablet, in sicer naj bo odmerek zaokrožen na najbližjo jakost cele tablete.
EXJADE 360 mg film-coated tablets 
EXJADE 360 mg filmsko obložene tablete
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%). 
Medsebojno delovanje z midazolamom in drugimi zdravili, katerih presnova poteka s CYP3A4 V študiji pri zdravih prostovoljcih je sočasen vnos deferasiroksa v obliki disperzibilnih tablet in midazolama (predstavnika substratov CYP3A4) povzročil zmanjšano izpostavljenost midazolamu za 17 % (90% IZ: 8 %-26 %).
In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not exceed 10 mg/kg. 
Pri pediatričnih bolnikih s katerim od sindromov talasemije, neodvisnih od transfuzij, odmerek ne sme preseči 10 mg/kg.
EXJADE 180 mg film-coated tablets 
EXJADE 180 mg filmsko obložene tablete
EXJADE 360 mg film-coated tablets Each film-coated tablet contains 360 mg deferasirox. 
EXJADE 360 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 360 mg deferasiroksa.
Starting dose The recommended initial daily dose of EXJADE dispersible tablets is 20 mg/kg body weight. 
Priporočeni začetni dnevni odmerek zdravila EXJADE v obliki disperzibilnih tablet je 20 mg/kg telesne mase.
Approximate tablet dimensions 15 mm x 4.7 mm. 
Približna velikost tablete je 15 mm x 4,7 mm.
EXJADE 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox. 
EXJADE 180 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 180 mg deferasiroksa.
Post-marketing cases of hepatic failure, some of which were fatal, have been reported. 
V obdobju trženja so poročali o primerih odpovedi jeter, od katerih se jih je nekaj končalo s smrtjo.
EXJADE dispersible tablets must therefore be taken on an empty stomach at least 30 minutes before food, preferably at the same time each day (see sections 4.2 and 5.2). 
Zato je treba zdravilo EXJADE v obliki disperzibilnih tablet jemati na prazen želodec vsaj 30 minut pred zaužitjem hrane, najbolje vsak dan ob istem času (glejte poglavji 4.2 in 5.2).
The MAH shall use distinct outer cartons, blisters and tablets for all formulations (dispersible tablets and film-coated tablets/granules). 
Imetnik dovoljenja za promet z zdravilom mora za vsako od vseh formulacij zdravila (disperzibilne tablete in filmsko obložene tablete oziroma zrnca) pripraviti drugačno zunanjo ovojnino (škatlo) ter drugačne pretisne omote in tablete.
30 film-coated tablets. 
filmsko obložene tablete 30 filmsko obloženih tablet.
After every 3 to 6 months of treatment, a dose increase in increments of 5 to 10 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. 
Po vsakih 3 do 6 mesecih zdravljenja je treba razmisliti o zvišanju odmerka v korakih po 5 do 10 mg/kg, če je pri bolniku koncentracija železa v jetrih ≥7 mg Fe/g suhe teže oziroma ima koncentracijo feritina v serumu ves čas >2.000 µg/l in ta ne kaže trenda zniževanja, bolnik pa zdravilo dobro prenaša.
EXJADE 90 mg film-coated tablets EXJADE 180 mg film-coated tablets EXJADE 360 mg film-coated tablets Deferasirox 
EXJADE 90 mg filmsko obložene tablete EXJADE 180 mg filmsko obložene tablete EXJADE 360 mg filmsko obložene tablete deferasiroks
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE dispersible tablets that is numerically half that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 20 mg/kg/day of EXJADE dispersible tablets). 
Pri bolnikih, ki so ob zdravljenju z deferoksaminom že dobro urejeni, je lahko primeren začetni odmerek zdravila EXJADE v obliki disperzibilnih tablet številčno enak polovici odmerka deferoksamina (npr. bolnik, ki prejema 40 mg/kg/dan deferoksamina 5 dni na teden (ali temu ekvivalenten odmerek), lahko preide na začetni dnevni odmerek 20 mg/kg/dan zdravila EXJADE v obliki disperzibilnih tablet).
EXJADE granules should be taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple). 
Zrnca je treba odmerjati tako, da se celoten odmerek primeša mehki hrani, na primer jogurtu ali jabolčni kaši.
Starting dose 14 mg/kg/day 20 mg/kg/day After 20 units (about 100 ml/kg) of PRBC 
14 mg/kg/dan 20 mg/kg/dan po 20 enotah (približno
• EXJADE 250 mg tablets are stamped “J 250” on one side and “NVR” on the other. 
• Tablete zdravila EXJADE 250 mg imajo na eni strani vtisnjeno oznako “J 250”, na drugi pa
These will monitor the amount of iron in your body (blood level of ferritin) to see how well EXJADE is working. 
Spremljanje vašega zdravljenja z zdravilom EXJADE Med zdravljenjem bodo z rednimi preiskavami krvi in urina spremljali količino železa v vašem telesu (vrednost feritina v krvi), da bi ugotovili, kako dobro učinkuje zdravilo EXJADE.
The multipacks contain 300 (10 packs of 30) film-coated tablets. 
Skupno pakiranje vsebuje 300 (10 pakiranj po 30) filmsko obloženih tablet.
OUTER CARTON OF MULTIPACK (including blue box) 
ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA (vključno z modrim okencem)
Anxiety, sleep disorder 
tesnoba, motnje spanja
Care should be taken to maintain adequate hydration in patients who experience volume-depleting events (such as diarrhoea or vomiting), particularly in children with acute illness. 
Pri bolnikih s težavami, ki povzročajo izgubo tekočine, (kot sta diareja in bruhanje), zlasti pri otrocih z akutno boleznijo, je treba poskrbeti za zadostno hidriranost organizma.
EXJADE 90 mg film-coated tablets 
EXJADE 90 mg filmsko obložene tablete
EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2). 
Zdravilo EXJADE v obliki zrnc ima večjo biološko uporabnost v primerjavi z zdravilom EXJADE v obliki disperzibilnih tablet (glejte poglavje 5.2).
• EXJADE 500 mg tablets are stamped “J 500” on one side and “NVR” on the other. 
• Tablete zdravila EXJADE 500 mg imajo na eni strani vtisnjeno oznako “J 500”, na drugi pa
>2,500 µg/l 
zviševanje pri >2.500 µg/l
Dizziness 
gluhost
Starting dose The recommended initial daily dose of EXJADE granules is 14 mg/kg body weight. 
Začetni odmerek Priporočeni začetni dnevni odmerek zdravila EXJADE v obliki zrnc je 14 mg/kg telesne mase.
Starting dose The recommended initial daily dose of EXJADE film-coated tablets is 14 mg/kg body weight. 
Priporočeni začetni dnevni odmerek zdravila EXJADE v obliki filmsko obloženih tablet je 14 mg/kg telesne mase.
Breast-feeding is not recommended during treatment with EXJADE. 
Med zdravljenjem z zdravilom EXJADE dojenje ni priporočljivo.
3.5 - 7 mg/kg/day 5-10 mg/kg/day Decrease 
3,5 - 7 mg/kg/dan 5-10 mg/kg/dan zniževanje
In patients not adequately controlled with doses of 30 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 40 mg/kg may be considered. 
Pri bolnikih, ki niso ustrezno urejeni ob zdravljenju z odmerkom 30 mg/kg (pri katerih na primer koncentracija feritina v serumu vztraja nad 2.500 µg/l in ne kaže trenda zniževanja s časom), je mogoče razmisliti o uporabi odmerkov do 40 mg/kg.
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. 
Zdravilo EXJADE je indicirano tudi za zdravljenje kronične preobremenitve z železom, ko je zdravljenje z deferoksaminom kontraindicirano ali neprimerno pri bolnikih, ki potrebujejo terapijo s kelacijo železa in so stari 10 let ali več ter imajo katerega od sindromov talasemije, neodvisnih od transfuzij.
EXJADE 180 mg film-coated tablets EU/1/06/356/014 
EXJADE 180 mg filmsko obložene tablete EU/1/06/356/014
Most of these patients had pre-existing haematological disorders that are frequently associated with bone marrow failure. 
Pri večini teh bolnikov so bile že prej prisotne hematološke bolezni, ki so pogosto povezane z depresijo kostnega mozga, vendar ni mogoče izključiti možnosti, da zdravilo EXJADE prispeva k nastopu citopenije ali jo poslabša.
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE film-coated tablets that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of EXJADE film-coated tablets). 
Pri bolnikih, ki so ob zdravljenju z deferoksaminom že dobro urejeni, je lahko primeren začetni odmerek zdravila EXJADE v obliki filmsko obloženih tablet številčno enak eni tretjini odmerka deferoksamina (npr. bolnik, ki prejema 40 mg/kg/dan deferoksamina 5 dni na teden (ali temu ekvivalenten odmerek), lahko preide na začetni dnevni odmerek 14 mg/kg/dan zdravila EXJADE v obliki filmsko obloženih tablet).
Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 180 on the other). 
Srednje modra ovalna bikonveksna filmsko obložena tableta z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in 180 na drugi strani).
EXJADE 180 mg granules EU/1/06/356/021 
EXJADE 180 mg zrnca EU/1/06/356/021
3.5 - 7 mg/kg/day Up to 28 mg/kg/day 
3,5 - 7 mg/kg/dan do 28 mg/kg/dan
• EXJADE 180 mg film-coated tablets are medium blue and stamped “180” on one side and 
• Filmsko obložene tablete zdravila EXJADE 180 mg so srednje modre in imajo na eni strani vtisnjeno oznako “180”, na drugi pa “NVR“.
EXJADE 360 mg film-coated tablets EU/1/06/356/017 
EXJADE 360 mg filmsko obložene tablete EU/1/06/356/017
EXJADE 360 mg granules EU/1/06/356/022 
EXJADE 360 mg zrnca EU/1/06/356/022
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE granules that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of EXJADE granules). 
Pri bolnikih, ki so ob zdravljenju z deferoksaminom že dobro urejeni, je lahko primeren začetni odmerek zdravila EXJADE v obliki zrnc številčno enak eni tretjini odmerka deferoksamina (npr. bolnik, ki prejema 40 mg/kg/dan deferoksamina 5 dni na teden (ali temu ekvivalenten odmerek), lahko preide na začetni dnevni odmerek 14 mg/kg/dan zdravila EXJADE v obliki zrnc).
EXJADE 90 mg film-coated tablets EU/1/06/356/011 
EXJADE 90 mg filmsko obložene tablete EU/1/06/356/011
There were no clinically relevant changes in deferasirox pharmacokinetics when EXJADE granules were administered with food. 
Pri odmerjanju zdravila EXJADE v obliki zrnc skupaj s hrano ni prišlo do klinično pomembnih sprememb v farmakokinetiki deferasiroksa.
EXJADE 90 mg granules EU/1/06/356/020 
EXJADE 90 mg zrnca EU/1/06/356/020
While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with EXJADE dispersible tablet doses above 30 mg/kg cannot be excluded. 
Čeprav v kliničnih študijah po postopnem zviševanju odmerkov zdravila EXJADE v obliki disperzibilnih tablet nad 30 mg/kg niso opažali povečanega obsega ledvičnih neželenih dogodkov, pri odmerkih zdravila EXJADE v obliki disperzibilnih tablet nad 30 mg/kg ni mogoče izključiti povečanega tveganja za ledvične neželene dogodke.
While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with film-coated tablet doses above 21 mg/kg cannot be excluded. 
Čeprav v kliničnih študijah zdravila EXJADE v obliki disperzibilnih tablet po postopnem zviševanju odmerkov nad 30 mg/kg niso opažali povečanega obsega ledvičnih neželenih dogodkov, pri uporabi zdravila v obliki filmsko obloženih tablet v odmerkih nad 21 mg/kg ni mogoče izključiti povečanega tveganja za ledvične neželene dogodke.
EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet 
EXJADE 90 mg zrnca v vrečici EXJADE 180 mg zrnca v vrečici EXJADE 360 mg zrnca v vrečici
EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet Deferasirox 
EXJADE 90 mg zrnca v vrečici EXJADE 180 mg zrnca v vrečici EXJADE 360 mg zrnca v vrečici deferasiroks
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. 
Bolnikom, ki ste jim odmerek zvišali na >10 mg/kg, je priporočljivo odmerek znižati na 10 mg/kg ali manj, če se jim koncentracija železa v jetrih zniža pod 7 mg Fe/g suhe teže ali imajo koncentracijo feritina v serumu ≤2.000 µg/l.
Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 360 on the other). 
Temno modra ovalna bikonveksna filmsko obložena tableta z zaobljenimi robovi in vtisnjenima oznakama (NVR na eni in 360 na drugi strani).
EXJADE 500 mg dispersible tablets Each dispersible tablet contains 500 mg deferasirox. 
EXJADE 500 mg disperzibilne tablete Ena disperzibilna tableta vsebuje 500 mg deferasiroksa.
EXJADE 250 mg dispersible tablets Each dispersible tablet contains 250 mg deferasirox. 
EXJADE 250 mg disperzibilne tablete Ena disperzibilna tableta vsebuje 250 mg deferasiroksa.
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). 
Pri uporabi zdravila EXJADE so poročali o hudih kožnih neželenih reakcijah (SCAR), med drugim o Stevens-Johnsonovem sindromu (SJS), toksični epidermalni nekrolizi (TEN) in reakcijah na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) (glejte poglavje 4.4).
In a 5-year observational study in which 267 children aged 2 to <6 years (at enrollment) with transfusional haemosiderosis received deferasirox, there were no clinically meaningful differences in the safety and tolerability profile of Exjade in paediatric patients aged 2 to <6 years compared to the overall adult and older paediatric population, including increases in serum creatinine of >33% and above the upper limit of normal on ≥2 consecutive occasions (3.1%), and elevation of alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (4.3%). 
V 5-letni opazovalni študiji, v kateri je deferasiroks prejemalo 267 otrok, ki so bili ob vključitvi stari od 2 do manj kot 6 let in so imeli transfuzijsko hemosiderozo, ni bilo klinično pomembnih razlik v profilih varnosti in prenašanja zdravila Exjade med pediatričnimi bolniki v starosti od 2 do manj kot 6 let in celotno populacijo odraslih ter starejših pediatričnih bolnikov.
EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation. 
Zdravilo EXJADE v obliki zrnc ima večjo biološko uporabnost v primerjavi z zdravilom EXJADE v obliki disperzibilnih tablet.
Exjade 360 mg film-coated tablets deferasirox 
Exjade 360 mg filmsko obložene tablete deferasiroks
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. 
V primeru prehoda z disperzibilnih tablet na zrnca mora biti odmerek pri zrncih za 30 % nižji od prejšnjega odmerka v obliki disperzibilnih tablet, in sicer naj bo odmerek zaokrožen na najbližjo jakost cele vrečice.
• Each sachet of EXJADE 180 mg granules contains 180 mg deferasirox. 
• Ena vrečica zdravila EXJADE 180 mg zrnca vsebuje 180 mg deferasiroksa.
EXJADE 125 mg dispersible tablets EU/1/06/356/001 
EXJADE 125 mg disperzibilne tablete EU/1/06/356/001
10 mg/kg/day ≥5 mg Fe/g dw or >800 µg/l 
10 mg/kg/dan ≥5 mg Fe/g suhe teže ali
EXJADE 125 mg dispersible tablets 
EXJADE 125 mg disperzibilne tablete
While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with granule doses above 21 mg/kg cannot be excluded. 
Čeprav v kliničnih študijah zdravila EXJADE v obliki disperzibilnih tablet po postopnem zviševanju odmerkov nad 30 mg/kg niso opažali povečanega obsega ledvičnih neželenih dogodkov, pri uporabi zdravila v obliki zrnc v odmerkih nad 21 mg/kg ni mogoče izključiti povečanega tveganja za ledvične neželene dogodke.
Each dispersible tablet contains 125 mg of deferasirox. 
Ena disperzibilna tableta vsebuje 125 mg deferasiroksa.
It is recommended that hyperammonaemic encephalopathy be considered and ammonia levels measured in patients who develop unexplained changes in mental status while on Exjade therapy. 
Pri bolnikih, pri katerih v času zdravljenja z zdravilom Exjade pride do nepojasnjenih sprememb duševnega stanja, je priporočeno upoštevati možnost, da gre za hiperamoniemično encefalopatijo, in jim meriti koncentracijo amonijaka.
Exjade 180 mg film-coated tablets deferasirox 
Exjade 180 mg filmsko obložene tablete deferasiroks