natgillin/translations-raw huggingface dataset:
Frequent transfusions are defined as at least 7 ml of packed (concentrated) red blood cells per kilogram body weight in a month. • Exjade is also used when deferoxamine (another medicine used to treat iron overload) cannot be used or is inadequate, in patients who suffer from other types of anaemia, in children aged from two to five years, and in patients with beta thalassaemia major who receive less frequent transfusions.
Pogoste transfuzije pomenijo najmanj 7 ml koncentriranih eritrocitov na kilogram telesne mase na mesec. • Zdravilo Exjade se uporablja tudi, kadar deferoksamina (drugo zdravilo za zdravljenje preobremenitve z železom) ni mogoče uporabljati ali je neprimeren pri bolnikih z drugimi vrstami slabokrvnosti, otrocih v starosti od dve do pet let in pri bolnikih z beta talasemijo major, ki prejemajo transfuzije manj pogosto.
Because the number of patients with chronic iron overload is low, the disease is considered ‘ rare’, and Exjade was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 13 March 2002.
Ker je število bolnikov s kronično preobremenitvijo z železom majhno, velja ta bolezen za „ redko “, zato je bilo zdravilo Exjade 13. marca 2002 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja za zdravljenje redkih bolezni).
Treatment with Exjade should be started and supervised by a doctor who is experienced in the treatment of chronic iron overload due to frequent transfusions.
Zdravljenje z zdravilom Exjade mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem kronične preobremenitve z železom zaradi pogostih transfuzij.
Only patients who have no problems with their kidneys can be treated with Exjade.
Z zdravilom Exjade se lahko zdravijo samo bolniki, ki nimajo težav z ledvicami.
The treatment starts once the patient has received about 100 ml of packed red blood cells per kilogram body weight, or once there are signs of iron overload (when the levels in the blood of ferritin, the protein in the body that stores iron, are over 1 mg per litre).
Zdravljenje se začne, ko bolnik prejme približno 100 ml koncentriranih eritrocitov na kilogram telesne mase ali ko se pojavijo znaki preobremenitve z železom (ko so ravni feritina, tj. beljakovine v telesu za skladiščenje železa, v krvi večje od 1 mg na liter).
The treatment usually starts using a dose of 20 mg per kilogram body weight.
Zdravljenje se običajno začne z odmerkom 20 mg na kg telesne mase.
Starting doses of 10 or 30 mg/ kg can also be used, depending on the frequency of the patient ’ s transfusions.
Lahko pa se uporabljajo tudi začetni odmerki 10 ali 30 mg/ kg telesne mase, odvisno od pogostosti transfuzij pri bolniku.
These doses are then adjusted as needed, every three to six months, according to the response.
Ti odmerki se po potrebi prilagajajo na vsakih tri do šest mesecev, odvisno od odziva.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged Zdravilo Exjade se jemlje vsak dan, po možnosti vsak dan ob istem času, na prazen želodec (vsaj 30 minut pred zaužitjem hrane).
Exjade is taken every day, preferably at the same time each day, on an empty stomach (at least 30 minutes before food).
Število tablet posamezne jakosti, ki sestavljajo odmerek, se določi na podlagi bolnikove telesne mase.
The tablets are dispersed by stirring them in a glass of water or fruit juice to make a suspension for the patient to drink.
Tablete se raztopijo z mešanjem v kozarcu vode ali sadnega soka (na primer pomarančnega ali jabolčnega), da nastane suspenzija, ki jo bolnik lahko spije.
When patients receive repeated transfusions to correct anaemia, the transfused red cells bring iron into the body.
Kadar bolniki prejemajo večkratne transfuzije za odpravo slabokrvnosti, se z eritrociti, vnesenimi s transfuzijo, vnese v telo tudi železo.
As the body does not have a natural way of removing excess iron, it can build up and, over time, damage important organs such as the heart or liver.
Ker pa telo ne more na naraven način odstraniti odvečnega železa, se to lahko kopiči in s časom poškoduje pomembne organe, kot sta srce ali jetra.
The active substance in Exjade, deferasirox, is an ‘ iron chelator’.
Zdravilna učinkovina v zdravilu Exjade, deferasiroks, je „ kelator železa “.
It binds to iron in the body to form a compound called a ‘ chelate ’ that can be excreted by the body, mainly in the stools.
Veže se na železo v telesu in tvori spojino „ kelat “, ki jo telo lahko izloči, in sicer pretežno z blatom.
This helps to correct the iron overload and prevent damage due to excess iron.
To pomaga odpravljati preobremenjenost z železom in preprečevati posledice zaradi odvečnega železa.
The effects of Exjade were first tested in experimental models before being studied in humans.
Učinki zdravila Exjade so bili najprej preskušeni poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The main study of effectiveness compared Exjade with deferoxamine in 591 patients with beta thalassaemia major.
V glavni študiji o učinkovitosti so zdravilo Exjade primerjali z deferoksaminom na 591 bolnikih z beta talasemijo major.
About half of the patients were under the age of 16, and 56 were less than six years old.
Približno polovica bolnikov je bila mlajših od 16 let, 56 pa mlajših od šest let.
The doctor and patients knew which medicine they were using because Exjade is given by mouth but deferoxamine is given by subcutaneous infusion (very slow injection under the skin) overnight.
Zdravnik in bolniki so vedeli, katero zdravilo uporabljajo, saj se zdravilo Exjade jemlje peroralno, deferoksamin pa se daje s subkutano infuzijo (zelo počasno injiciranje pod kožo) prek noči.
The effectiveness was measured by looking at the level of iron contained in the liver before and after one year of treatment with the medicines.
Učinkovitost so merili z opazovanjem ravni železa v jetrih pred enoletnim zdravljenjem z zdravili in po njem.
An additional study looked at the effectiveness of Exjade in 184 patients who could not be treated with deferoxamine, including patients with beta thalassaemia major and with other types of anaemia.
V dodatni študiji so preučevali učinkovitost zdravila Exjade pri 184 bolnikih, ki ne morejo jemati deferoksamina, med katerimi so bili bolniki z beta talasemijo major in drugimi vrstami slabokrvnosti.
At the end of the main study, 53% of the patients receiving Exjade had shown a sufficient response to treatment, compared with 66% of the patients receiving deferoxamine.
Na koncu glavne študije je 53% bolnikov, ki so prejemali zdravilo Exjade, izkazalo zadosten odziv na zdravljenje v primerjavi s 66% bolnikov, ki so prejemali deferoksamin.
This indicates that Exjade may not have been as effective as the comparator medicine.
To kaže, da zdravilo Exjade morda ni tako učinkovito kot primerjalno zdravilo.
However, when looking at the 381 patients who had particularly high levels of iron in their liver at the beginning of the study and who received comparable amounts of Exjade or deferoxamine, the two medicines were as effective as each other.
Vendar pa sta bili pri 381 bolnikih, ki so imeli posebno visoke ravni železa v jetrih na začetku študije in so prejemali primerjalne količine zdravila Exjade ali deferoksamina, obe zdravili enako učinkoviti.
There were too few patients in this study aged below six years to demonstrate the safety and effectiveness of Exjade in this age group.
V študiji je sodelovalo premalo bolnikov, mlajših od šest let, da bi lahko potrdili varnost in učinkovitost zdravila Exjade v tej starostni skupini.
In the additional study, more than half of the patients who could not be treated with deferoxamine had responded to treatment with Exjade after a year, including patients aged between two and five years.
V dodatni študiji se je več kot polovica bolnikov, ki ni mogla prejemati deferoksamina, po enem letu odzvala na zdravljenje z zdravilom Exjade, vključno z bolniki, starimi od dve do pet let.
The most common side effect with Exjade (seen in more than 1 patient in 10) is increased blood creatinine (a marker of kidney problems).
Najpogostejši neželeni učinek zdravila Exjade (opažen pri več kot 1 bolniku od 10) je zvišana raven kreatinina (označevalec težav z jetri) v krvi.
For the full list of all side effects reported with Exjade, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Exjade, glejte navodilo za uporabo.
Exjade should not be used in people who may be hypersensitive (allergic) to deferasirox or any of the other ingredients, or in people whose creatinine clearance (a measure of the ability of the kidney to remove creatinine from the blood) is below 60 ml per minute.
Zdravila Exjade ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) deferasiroks ali katero koli drugo sestavino zdravila, ali osebe z očistkom kreatinina (mera za zmožnost ledvic za odstranjevanje kreatinina iz krvi) pod 60 ml na minuto.
It should not be used in combination with other iron chelators.
Zdravilo se ne sme uporabljati v kombinaciji z drugimi kelatorji železa.
It is very important that the patient ’ s kidneys and liver are checked with blood tests before treatment with Exjade is started, and regularly during treatment.
Zelo pomembno je, da se pred začetkom zdravljenja z zdravilom Exjade in nato redno med samim zdravljenjem s krvnimi testi preverijo bolnikova jetra in ledvice.
Exjade is not recommended for patients with severe liver problems as it has not been tested in this group.
Zdravilo Exjade ni priporočeno za uporabo pri bolnikih s hudimi težavami z jetri, saj v tej skupini ni bilo preskušeno.
The Committee for Medicinal Products for Human Use (CHMP) decided that Exjade’ s benefits are greater than its risks for the treatment of chronic iron overload due to frequent blood transfusions in patients with beta thalassaemia major, and due to blood transfusions when deferoxamine therapy is contraindicated or inadequate.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Exjade pri zdravljenju kronične preobremenjenosti z železom, ki je posledica pogostih krvnih transfuzij pri bolnikih z beta talasemijo major ali krvnih transfuzij, kadar je zdravljenje z deferoksaminom kontraindicirano ali neustrezno, večje od z njim povezanih tveganj.
The Committee recommended that the medicine be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Exjade odobri dovoljenje za promet.
2/ 3 Which measures are being taken to ensure the safe use of Exjade?
2/ 3 Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Exjade?
The company responsible for making Exjade available must prepare an education pack for doctors, which is distributed whenever the medicine is launched.
Družba, odgovorna za razpoložljivost zdravila Exjade, mora pripraviti paket za usposabljanje zdravnikov, ki ga je treba razdeliti vsakič, ko je zdravilo dano na trg.
This pack will ensure that doctors know about the need to monitor the patient ’ s health, especially kidney function, when they prescribe the medicine.
Te informacije bodo zagotovile, da se bodo zdravniki pri predpisovanju zdravila zavedali potrebe po spremljanju bolnikovega zdravja, zlasti delovanja ledvic.
The company will also prepare a similar pack for patients.
Podoben paket bo družba pripravila tudi za bolnike.
Other information about Exjade The European Commission granted a marketing authorisation valid throughout the European Union for Exjade to Novartis Europharm Limited on 28 August 2006.
Evropska komisija je dovoljenje za promet z zdravilom Exjade, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 28. avgusta 2006.
The summary of opinion of the Committee for Orphan Medicinal Products for Exjade is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Exjade je na voljo tukaj.
The full EPAR for Exjade can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Exjade je na voljo tukaj.
EU Number
Številka EU EU/ 1/ 06/ 356/ 001
Invented name
Jakost 125 mg
Strength
84 tablet
Pharmaceutical Form
EU/ 1/ 06/ 356/ 003
Route of Administration
EU/ 1/ 06/ 356/ 004
Packaging
84 tablet
Package size
28 tablet
Exjade Exjade Exjade Exjade Exjade Exjade Exjade Exjade Exjade
Tableta za peroralno suspenzijo Peroralna uporaba
Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet Dispersible tablet
Tableta za peroralno suspenzijo Peroralna uporaba
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Tableta za peroralno suspenzijo Peroralna uporaba
Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu) Blister (PVC/ PE/ PVDC/ alu)
PVC/ PE/ PVDC/ aluminijski pretisni omoti
28 tablets 84 tablets 28 tablets 84 tablets 28 tablets 84 tablets 252 tablets 252 tablets 252 tablets
Tableta za peroralno suspenzijo Peroralna uporaba
This product contains lactose.
To zdravilo vsebuje laktozo.
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 zdravljenje kronične preobremenitve z železom zaradi pogostih transfuzij krvi (≥7 ml/ kg/ mesec koncentriranih eritrocitov) pri bolnikih z beta talasemijo major, starih 6 let ali več.
EXJADE 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:
EXJADE je indiciran tudi za zdravljenje kronične preobremenitve z železom zaradi transfuzij krvi v primerih, ko je zdravljenje z deferoksaminom kontraindicirano ali neprimerno pri naslednjih skupinah bolnikov:
- in patients with other anaemias,
- pri bolnikih z drugimi anemijami,
- in patients aged 2 to 5 years,
- pri bolnikih v starosti od 2 do 5 let,
- in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions
- pri bolnikih z beta talasemijo major s preobremenitvijo z železom zaradi manj pogostih
(< 7 ml/ kg/ month of packed red blood cells).
transfuzij krvi (< 7 ml/ kg/ mesec koncentriranih eritrocitov).
Treatment with EXJADE should be initiated and maintained by physicians experienced in the treatment of chronic iron overload due to blood transfusions.
Zdravljenje z zdravilom EXJADE naj uvede in nadaljuje zdravnik z izkušnjami pri zdravljenju kronične preobremenitve z železom zaradi krvnih transfuzij.
It is recommended that treatment be started after the transfusion of approximately 20 units (about 100 ml/ kg) of packed red blood cells or when there is evidence from clinical monitoring that chronic iron overload is present (e. g. serum ferritin > 1,000 µg/ l).
Priporočeno je, da se zdravljenje prične po transfuziji približno 20 enot (okrog 100 ml/ kg) koncentriranih eritrocitov ali ob prisotnosti znakov kronične preobremenitve z železom, ugotovljenih s kliničnim spremljanjem (npr. feritin v serumu > 1. 000 µg/ l).
Doses (in mg/ kg) must be calculated and rounded to the nearest whole tablet size.
Odmerke (v mg/ kg) je treba izračunati in zaokrožiti na najbližjo vrednost jakosti tablete.
The goals of iron chelation therapy are to remove the amount of iron administered in transfusions and, as required, to reduce the existing iron burden.
Namena terapije s kelacijo železa sta odstraniti količino železa, ki je bila vnešena s transfuzijo, in po potrebi zmanjšati obstoječo obremenitev z železom.
Starting dose U
odmerek UZačetni
The recommended initial daily dose of EXJADE is 20 mg/ kg body weight.
Priporočeni začetni dnevni odmerek zdravila EXJADE je 20 mg/ kg telesne mase.
An initial daily dose of 30 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).
Začetni dnevni odmerek 30 mg/ kg je lahko primeren za bolnike, pri katerih je treba znižati zvišano raven železa v organizmu in pri tem prejemajo več kot 14 ml/ kg/ mesec koncentriranih eritrocitov (približno > 4 enote/ mesec pri odraslem).
2 An initial daily dose of 10 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).
Začetni dnevni odmerek 10 mg/ kg je lahko primeren za bolnike, pri katerih ni treba znižati ravni železa v organizmu in prejemajo manj kot 7 ml/ kg/ mesec koncentriranih eritrocitov (približno < 2 enoti/ mesec pri odraslem).
The patient’ s response must be monitored and a dose increase should be considered if sufficient efficacy is not obtained (see section 5.1).
Bolnikov odziv je treba spremljati in v primerih, ko ne pride do zadostne učinkovitosti, razmisliti o zvišanju odmerka (glejte poglavje 5. 1).
For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE 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).
2 Pri bolnikih, ki so ob zdravljenju z deferoksaminom že dobro urejeni, je lahko primeren začetni odmerek zdravila EXJADE 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).
When this results in a daily dose less than 20 mg/ kg body weight, the patient’ s response must be monitored and a dose increase should be considered if sufficient efficacy is not obtained (see section 5.1).
Če to pomeni dnevni odmerek, ki bi bil nižji od 20 mg/ kg telesne mase, je treba spremljati bolnikov odziv in v primerih, ko ne pride do zadostne učinkovitosti, razmisliti o zvišanju odmerka (glejte poglavje 5. 1).
Maintenance dose U
odmerek UVzdrževalni
It is recommended that serum ferritin be monitored every month and that the dose of EXJADE be adjusted, if necessary, every 3 to 6 months based on the trends in serum ferritin.
Priporočeno je spremljanje feritina v serumu vsak mesec in prilagajanje odmerka zdravila EXJADE po potrebi vsakih 3 do 6 mesecev glede na trend feritina v serumu.
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).
Prilagajanje odmerka lahko poteka v korakih po 5 do 10 mg/ kg, prirediti jih je potrebno odzivu in ciljem zdravljenja posameznega bolnika (vzdrževanje ali zmanjševanje obremenitve z železom).
Doses above 30 mg/ kg are not recommended because there is only limited experience with doses above this level.
Odmerki nad 30 mg/ kg niso priporočljivi, saj so na voljo le omejene izkušnje z odmerki nad to vrednostjo.
If serum ferritin falls consistently below 500 µg/ l, an interruption of treatment should be considered (see section 4.4).
Če feritin v serumu večkrat pade pod 500 µg/ l, je treba razmisliti o prekinitvi zdravljenja (glejte poglavje 4. 4).
Preparation U
UPriprava
EXJADE 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).
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).
The tablets are dispersed by stirring in a glass of water or orange or apple juice (100 to 200 ml) until a fine suspension is obtained.
Tablete se raztopijo z mešanjem v kozarcu vode ali pomarančnega ali jabolčnega soka (100 do 200 ml) dokler ne nastane redka suspenzija.
The tablets must not be chewed or swallowed whole (see also section 6.2).
Tablet se ne sme žvečiti ali pogoltniti celih (glejte tudi poglavje 6. 2).
Elderly patients (≥ 65 years of age) U
bolniki (stari ≥65 let) UStarejši
Paediatric patients (2 to 17 years of age) U
bolniki (stari od 2 do 17 let) UPediatrični
The dosing recommendations for paediatric patients are the same as for adult patients.
Priporočeno odmerjanje za pediatrične bolnike je enako kot za odrasle.
In children aged between 2 and 5 years, exposure is lower than in adults (see section 5.2).
Pri otrocih starih med 2 in 5 let je izpostavljenost zdravilu nižja kot pri odraslih (glejte poglavje 5. 2).
Patients with renal impairment U
z okvaro ledvic UBolniki
EXJADE has not been studied in patients with renal impairment and is contraindicated in patients with estimated creatinine clearance < 60 ml/ min (see sections 4.3 and 4.4).
Pri bolnikih z okvaro ledvic uporaba zdravila EXJADE ni proučena in je kontraindicirana pri bolnikih z oceno očistka kreatinina < 60 ml/ min (glejte poglavji 4. 3 in 4. 4).
Patients with hepatic impairment U
z okvaro jeter UBolniki
EXJADE has not been studied in patients with hepatic impairment and must be used with caution in such patients.
Pri bolnikih z okvaro jeter uporaba zdravila EXJADE ni proučena, pri takih bolnikih je potrebna previdnost pri uporabi.
The initial dosing recommendations for patients with hepatic impairment are the same as described above.
Priporočeno začetno odmerjanje za bolnike z okvaro jeter je enako zgoraj opisanemu.
Hepatic function in all patients should be monitored before treatment then every month (see section 4.4).
Pri vseh bolnikih je treba jetrno funkcijo izmeriti pred zdravljenjem, nato pa jo spremljati vsak mesec (glejte poglavje 4. 4).
Combination with other iron chelator therapies as the safety of such combinations has not been established (see section 4.5).
Kombinacija zdravljenja z drugimi kelatorji železa, saj varnost takih kombinacij ni bila ugotovljena (glejte poglavje 4. 5).
Patients with estimated creatinine clearance < 60 ml/ min.
Bolniki z oceno očistka kreatinina < 60 ml/ min.
Renal function:
ledvic:
U
UDelovanje
EXJADE has been studied only in patients with baseline serum creatinine within the age-appropriate normal range.
EXJADE je bil proučen samo pri bolnikih z izhodiščno koncentracijo kreatinina v serumu v okviru starostno ustreznih normalnih vrednosti.
During clinical trials, 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.
V kliničnih preskušanjih je pri približno 36% bolnikov prišlo do zvišanja kreatinina v serumu za > 33% na dveh ali več zaporednih obiskih, nekajkrat preko zgornje meje normalnih vrednosti.
These were dose- dependent.
Ta zvišanja so bila odvisna od odmerka.
About two-thirds of the patients showing serum creatinine increase returned below the 33% level without dose adjustment.
Približno pri dveh tretjinah bolnikov z zvišanjem kreatinina v serumu se je ta vrnil pod raven 33% zvišanja brez prilagajanja odmerka.
In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption.
Pri preostali tretjini bolnikov se zvišanje kreatinina v serumu ni vedno odzvalo na zniževanje odmerka ali prekinitev zdravljenja.
Cases of acute renal failure have been reported following post-marketing use of EXJADE (see section 4.8).
Na podlagi postmarketinške uporabe zdravila EXJADE so poročali o primerih akutne ledvične odpovedi (glejte poglavje 4. 8).
Particular attention should therefore be paid to monitoring of serum creatinine in patients who are receiving high doses of EXJADE and/ or low rates of transfusion (< 7 ml/ kg/ month of packed red blood cells or < 2 units/ month for an adult).
Zato je treba posebej pozorno spremljati koncentracijo kreatinina v serumu pri tistih bolnikih, ki prejemajo visoke odmerke zdravila EXJADE in/ ali transfuzije z majhno intenzivnostjo (< 7 ml/ kg/ mesec koncentriranih eritrocitov ali < 2 enoti/ mesec pri odraslem).