natgillin/translations-raw huggingface dataset:
If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).
Če je uporaba kombinacije teh dveh zdravil nujna, je treba bolnika skrbno klinično spremljati in mu meriti koncentracijo glukoze v krvi (glejte poglavje 4.4).
They should be monitored closely by their doctor for side effects that may require a dose adjustment.
Zdravnik mora starejše bolnike bolj skrbno spremljati glede neželenih učinkov, zaradi katerih bi bilo morda treba prilagoditi odmerek.
Deferasirox Mylan is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
Uporaba zdravila Deferasiroks Mylan ni priporočena pri bolnikih s hudo okvaro jeter (Child-Pugh stopnje C).
Caution should be exercised in patients who are taking Deferasirox Mylan in combination with substances that have known ulcerogenic potential, such as NSAIDs, corticosteroids, or oral bisphosphonates, in patients receiving anticoagulants and in patients with platelet counts below 50,000/mm³ (50 × 10
Previdnost je potrebna pri bolnikih, ki jemljejo zdravilo Deferasiroks Mylan v kombinaciji z zdravilnimi učinkovinami, za katere je znano, da lahko povzročajo ulkuse, kot so nesteroidna protivnetna zdravila, kortikosteroidi ali peroralni difosfonati, pri bolnikih, ki prejemajo antikoagulante, in pri bolnikih s koncentracijo trombocitov, ki je nižja od 50.000/mm
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.
Pri bolnikih z zmerno okvaro jeter (Child-Pugh stopnje B) je treba odmerek znatno znižati in nato postopno zviševati do meje 50 % (glejte poglavji 4.4 in 5.2).
For patients who are unable to swallow whole tablets, Deferasirox Mylan film-coated tablets may be crushed and taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple).
Za bolnike, ki ne morejo pogoltniti celih tablet, je mogoče filmsko obložene tablete Deferasiroks Mylan zdrobiti in celoten odmerek primešati mehki hrani, na primer jogurtu ali jabolčni kaši.
However, in patients with liver iron concentration <7 mg Fe/g dw treated with deferasirox dispersible tablets (5 and 10 mg/kg) or deferoxamine (20 to 35 mg/kg), non-inferiority was not established due to imbalance in the dosing of the two chelators.
Pri bolnikih s koncentracijo železa v jetrih <7 mg Fe/g suhe teže, zdravljenih bodisi z deferasiroksom v obliki disperzibilnih tablet (5 in 10 mg/kg) ali deferoksaminom (20 do 35 mg/kg) pa neinferiornost ni bila ugotovljena zaradi neuravnoteženega odmerjanja obeh kelatorjev.
Abnormal serum creatinine and creatinine clearance values were reported in 5.5% and 1.8% of patients, respectively.
O nenormalni koncentraciji kreatinina v serumu so poročali pri 5,5 % bolnikov, o nenormalni vrednosti očistka kreatinina pa pri 1,8 % bolnikov.
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.
Poleg tega je pri bolnikih s koncentracijo železa v jetrih ≥7 mg Fe/g suhe teže in z različnimi redkimi vrstami anemije ali s srpastocelično anemijo deferasiroks v obliki disperzibilnih tablet v odmerkih do 20 in 30 mg/kg povzročil primerljivo znižanje koncentracije železa v jetrih in feritina v serumu v primerjavi z bolniki z beta talasemijo.
Increase 3.5 - 7 mg/kg/day
zviševanje 3,5 - 7 mg/kg/dan
In a clinical study using single doses of 20 mg/kg deferasirox dispersible tablets, the average exposure was increased by 16% in subjects with mild hepatic impairment (Child-Pugh Class A) and by 76% in subjects with moderate hepatic impairment (Child-Pugh Class B) compared to subjects with normal hepatic function.
V klinični študiji z enkratnimi odmerki deferasiroksa 20 mg/kg v obliki disperzibilnih tablet je bila pri bolnikih z blago okvaro jeter (Child-Pugh stopnje A) povprečna izpostavljenost za 16 % večja kot pri bolnikih z normalnim delovanjem jeter, pri bolnikih z zmerno okvaro jeter (Child-Pugh stopnje B) pa je bila večja za 76 %.
Treatment with Deferasirox Mylan should be initiated and maintained by physicians experienced in the treatment of chronic iron overload.
Zdravljenje z zdravilom Deferasiroks Mylan naj uvede in nadaljuje zdravnik z izkušnjami pri zdravljenju kronične preobremenitve z železom.
There have been post-marketing reports of metabolic acidosis.
V obdobju trženja zdravila so poročali o pojavu metabolne acidoze.
Interaction with repaglinide and other agents metabolised by CYP2C8
Medsebojno delovanje z repaglinidom in drugimi zdravili, katerih presnova poteka s CYP2C8
Very common (may affect more than 1 in 10 people)
Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov)
Interaction with midazolam and other agents metabolised by CYP3A4
Medsebojno delovanje z midazolamom in drugimi zdravili, katerih presnova poteka s CYP3A4
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).
Terapijo s kelacijo železa je primerno uvesti samo v primeru dokazane preobremenitve z železom (pri koncentraciji železa v jetrih ≥5 mg Fe/g suhe teže oziroma pri koncentraciji feritina v serumu ves čas >800 µg/l).
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.
Po vsakih 3 do 6 mesecih zdravljenja je treba razmisliti o zvišanju odmerka v korakih po 3,5 do 7 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.
Cardiac function should be monitored in patients with severe iron overload during long-term treatment with Deferasirox Mylan.
Pri bolnikih s hudo preobremenitvijo z železom je treba med dolgotrajnim zdravljenjem z zdravilom Deferasiroks Mylan spremljati delovanje srca.
[Bottles]
[Pretisni omoti]
• Glycosuria in non-diabetics and low levels of serum potassium, phosphate, magnesium or urate, phosphaturia, aminoaciduria (monitor as needed).
v primeru glikozurije pri tistih, ki nimajo sladkorne bolezni, in v primeru nizkih koncentracij kalija, fosfatov, magnezija ali uratov v serumu, fosfaturije in aminoacidurije (s spremljanjem po potrebi).
For patients who are unable to swallow whole tablets, the film-coated tablets may be crushed and administered by sprinkling the full dose onto soft food, e.g. yogurt or apple sauce (pureed apple).
Za bolnike, ki ne morejo pogoltniti celih tablet, je mogoče filmsko obložene tablete zdrobiti in celoten odmerek primešati mehki hrani, na primer jogurtu ali jabolčni kaši.
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).
Priporočeno je mesečno spremljanje vrednosti feritina v serumu zaradi presoje bolnikovega odziva na zdravljenje in za preprečevanje prekomerne kelacije (glejte poglavje 4.2).
The average Cmax of deferasirox in subjects with mild or moderate hepatic impairment was increased by 22%.
Pri bolnikih z blago ali zmerno okvaro jeter je bila povprečna Cmax deferasiroksa višja za 22 %.
Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with Deferasirox Mylan.
O renalni tubulopatiji so poročali večinoma pri otrocih in mladostnikih, ki so imeli beta talasemijo in so prejemali zdravilo Deferasiroks Mylan.
• The need for annual auditory and ophthalmic testing
• potreba po letnem testiranju sluha in vida;
On average, serum ferritin decreased by 222.0 µg/l in patients treated with deferasirox dispersible tablets (starting dose 10 mg/kg/day) and increased by 115 µg/l in patients treated with placebo (p<0.001).
Koncentracija feritina se je v povprečju znižala za 222,0 µg/l pri bolnikih, ki so prejemali deferasiroks v obliki disperzibilnih tablet (z začetnim odmerkom 10 mg/kg/dan) in se zvišala za 115 µg/l pri bolnikih, ki so prejemali placebo (p<0,001).
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.
Pri bolnikih, ki niso ustrezno urejeni ob zdravljenju z odmerkom 21 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 28 mg/kg.
Deferasirox Mylan can be used by people aged 65 years and over at the same dose as for other adults.
Ljudje, ki so stari 65 let ali več, lahko uporabljajo zdravilo Deferasiroks Mylan v enakih odmerkih kot odrasli.
Deferasirox Mylan is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2).
Uporaba zdravila Deferasiroks Mylan ni priporočena pri bolnikih s hudo okvaro jeter (Child-Pugh stopnje C) (glejte poglavje 5.2).
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 pretisnem omotu in škatli poleg oznak Uporabno do in EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
There have been post-marketing reports of metabolic acidosis occurring during treatment with deferasirox.
V obdobju trženja zdravila so poročali o pojavu metabolne acidoze med zdravljenjem z deferasiroksom.
The recommended initial daily dose of Deferasirox Mylan film-coated tablets is 14 mg/kg body weight.
Priporočeni začetni dnevni odmerek zdravila Deferasiroks Mylan v obliki filmsko obloženih tablet je 14 mg/kg telesne mase.
Transfusional iron overload:
Preobremenitev z železom zaradi transfuzij:
[Unit dose blisters] 30 × 1 film-coated tablets
[Enoodmerni pretisni omoti] 30 x 1 filmsko obložena tableta
In these patients, closer monitoring of LIC and serum ferritin is essential to avoid over-chelation (see section 4.4).
Pri teh bolnikih je nujno natančno spremljati koncentracijo železa v jetrih in feritina v serumu, da ne pride do prekomerne kelacije (glejte poglavje 4.4).
(acquired Fanconi syndrome), glycosuria
(pridobljeni Fanconijev sindrom),
Once a satisfactory body iron level has been achieved (LIC <3 mg Fe/g dw or serum ferritin <300 µg/l), treatment should be stopped.
Ko bolnik doseže zadovoljivo raven železa v telesu (koncentracijo železa v jetrih <3 mg Fe/g suhe teže ali koncentracijo feritina v serumu <300 µg/l), je treba zdravljenje zaključiti.
Deferasirox Mylan is not recommended for children aged under 2 years.
Uporaba zdravila Deferasiroks Mylan pri otrocih, mlajših od 2 leti, ni priporočljiva.
When serum creatinine is elevated and if another abnormality has been detected (e.g. proteinuria, signs of Fanconi syndrome).
• kadar je koncentracija kreatinina v serumu zvišana in se ugotovi še druga nepravilnost (kot je proteinurija, znaki Fanconijevega sindroma);
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.
V presnovni študiji ravnovesja železa je pri odraslih bolnikih s talasemijo in preobremenitvijo z železom deferasiroks v dnevnem odmerku 10, 20 in 40 mg/kg (v obliki disperzibilnih tablet) povzročil povprečno neto ekskrecijo 0,119; 0,329 oziroma 0,445 mg Fe/kg telesne mase/dan.
• 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 and lead to a change in your brain function),
zmanjšano stopnjo pozornosti ali zavedanja ali postanete zelo zaspani in vam primanjkuje energije (znaki zvišane vrednosti amonijaka v krvi, kar je lahko povezano s težavami z jetri ali ledvicami in lahko vpliva na delovanje možganov),
Acidbase balance should be monitored as clinically indicated in these populations.
Pri navedenih skupinah bolnikov je potreben nadzor kislinsko-baznega ravnovesja v skladu s kliničnimi indikacijami.
• Disturbance in kidney function tests.
• nepravilnosti v izvidih preiskav delovanja ledvic.
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 železa v jetrih se je v povprečju znižala za 3,80 mg Fe/g suhe teže pri bolnikih, ki so prejemali deferasiroks v obliki disperzibilnih tablet (z začetnim odmerkom 10 mg/kg/dan) in se zvišala za 0,38 mg Fe/g suhe teže pri bolnikih, ki so prejemali placebo (p<0,001).
Daily treatment with the deferasirox dispersible tablet formulation at doses of 20 and 30 mg/kg for one year in frequently transfused adult and paediatric patients with beta-thalassaemia led to reductions in indicators of total body iron; liver iron concentration was reduced by about −0.4 and −8.9 mg Fe/g liver (biopsy dry weight (dw)) on average, respectively, and serum ferritin was reduced by about −36 and −926 µg/l on average, respectively.
Pri odraslih in pediatričnih bolnikih z beta talasemijo in s pogostimi transfuzijami je vsakodnevno zdravljenje z deferasiroksom v obliki disperzibilnih tablet z odmerki 20 in 30 mg/kg v obdobju enega leta povzročilo zmanjšanje kazalcev celotnega železa v organizmu: koncentracija železa v jetrih se je znižala v povprečju za približno 0,4 oziroma 8,9 mg Fe/g jeter (suhe teže bioptičnega materiala (suhe teže)), vrednost feritina v serumu pa se je v povprečju znižala za približno 36 oziroma 926 µg/l.
LIC is the preferred method of iron overload determination and should be used wherever available.
Merjenje koncentracije železa v jetrih je metoda izbora pri določanju preobremenitve z železom in jo je treba uporabljati, če je le na razpolago.
Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with deferasirox.
O renalni tubulopatiji so poročali večinoma pri otrocih in mladostnikih, ki so deferasiroks prejemali zaradi beta talasemije.
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).
Začetni dnevni odmerek 7 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).
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.
Zdravilo Deferasiroks Mylan je indicirano tudi za zdravljenje kronične preobremenitve z železom zaradi transfuzij krvi v primerih, ko je zdravljenje z deferoksaminom kontraindicirano ali neprimerno pri naslednjih skupinah bolnikov: - pri pediatričnih bolnikih, ki imajo beta talasemijo major in preobremenitev z železom zaradi pogostih transfuzij krvi (7 ml/kg/mesec koncentriranih eritrocitov) in so stari od 2 do 5 let, - pri odraslih in pediatričnih bolnikih, ki imajo beta talasemijo major in preobremenitev z železom zaradi manj pogostih transfuzij krvi (<7 ml/kg/mesec koncentriranih eritrocitov) in so stari 2 leti ali več,
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).
Začetni dnevni odmerek 21 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).
In patients with a short life expectancy (e.g. high-risk myelodysplastic syndromes), especially when co-morbidities could increase the risk of adverse events, the benefit of Deferasirox Mylan might be limited and may be inferior to risks.
Pri bolnikih z nižjo pričakovano življenjsko dobo (kot je na primer pri mielodisplastičnih sindromih z visokim tveganjem) je lahko korist, ki jo prinaša zdravilo Deferasiroks Mylan, omejena in ne dosega vedno ravni tveganja, zlasti kadar bi se zaradi drugih sočasno prisotnih bolezni lahko povečalo tveganje za neželene dogodke.
As with other iron chelator treatment, high-frequency hearing loss and lenticular opacities (early cataracts) have been uncommonly observed in patients treated with deferasirox (see section 4.4).
Kot pri drugih vrstah zdravljenja s kelatorji železa, so tudi pri bolnikih, zdravljenih z deferasiroksom, občasno opazili izgubo sluha za visoke frekvence in motnjavo leče (zgodnje katarakte) (glejte poglavje 4.4).
• Severe upper stomach pain (pancreatitis)
• hude bolečine v zgornjem delu trebuha (vnetje trebušne slinavke)
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.
V enoletni študiji pri bolnikih, ki imajo preobremenitev z železom in katerega od sindromov talasemije, neodvisnih od transfuzij, (prejemali so disperzibilne tablete v odmerku 10 mg/kg/dan) so bili najbolj pogosti s študijskim zdravilom povezani neželeni dogodki naslednji: diareja (9,1 %), izpuščaj (9,1 %) in navzea (7,3 %).
After dose reduction, interrupt treatment, if Adult and paediatric Remains >33% above pre-treatment average and/or Decreases <LLN
prekinitev zdravljenja po znižanju odmerka, če: odrasli in pediatrični bolniki vrednost vztraja >33 % nad povprečjem vrednosti pred zdravljenjem in/ali znižanje pod spodnjo mejo normale (<90 ml/min)
In addition to monthly serum ferritin assessments, LIC should be monitored every three months when serum ferritin is ≤800 µg/l.
Poleg merjenja feritina v serumu enkrat mesečno je treba koncentracijo železa v jetrih meriti vsake tri mesece, kadar je koncentracija feritina v serumu ≤800 µg/l.
Exposure was increased 2.8-fold in one subject with severe hepatic impairment (Child-Pugh Class C) (see sections 4.2 and 4.4).
Pri enem bolniku s hudo okvaro jeter (Child-Pugh stopnje C) je bila izpostavljenost 2,8krat večja (glejte poglavji 4.2 in 4.4).
Blood and lymphatic system disorders Not known:
Bolezni krvi in limfatičnega sistema neznana pogostnost:
What Deferasirox Mylan looks like and contents of the pack Deferasirox Mylan is supplied as film-coated tablets.
Izgled zdravila Deferasiroks Mylan in vsebina pakiranja Zdravilo Deferasiroks Mylan je na voljo v obliki filmsko obloženih tablet.
Auditory (decreased hearing) and ocular (lens opacities) disturbances are uncommon, and yearly examinations are also recommended (see section 4.4).
Občasno pride do težav s sluhom (slabšanje sluha) in vidom (motnjave leče), zato so priporočeni vsakoletni pregledi (glejte poglavje 4.4).
Deferasirox Mylan is not recommended during pregnancy unless clearly necessary.
Uporaba zdravila Deferasiroks Mylan med nosečnostjo ni priporočljiva, če ni nujno potrebno.
If you miss a dose, take it as soon as you remember on that day.
Če ste pozabili vzeti zdravilo Deferasiroks Mylan Če ste pozabili vzeti odmerek, ga vzemite isti dan, takoj ko se spomnite.
Do not stop taking Deferasirox Mylan unless your doctor tells you to.
Če ste prenehali jemati zdravilo Deferasiroks Mylan Ne prenehajte jemati zdravila Deferasiroks Mylan, če vam tega ne naroči zdravnik.
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.
Naknadna analiza te študije pa je pokazala, da so bili kriteriji za neinferiornost doseženi pri podskupini bolnikov, pri katerih je bila koncentracija železa v jetrih ≥7 mg Fe/g suhe teže, zdravljeni pa so bili bodisi z deferasiroksom v obliki disperzibilnih tablet (20 in 30 mg/kg) ali deferoksaminom (35 do ≥50 mg/kg).
The pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the upper limit of the normal range.
Vrednosti jetrnih transaminaz do 5-kratnika zgornje meje normalnega okvira niso vplivale na farmakokinetiko deferasiroksa.
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%).
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 %).
• If you experience frequent heartburn,
• če vas pogosto muči zgaga,
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%).
V študiji pri zdravih prostovoljcih je sočasna uporaba deferasiroksa (v enkratnem odmerku 30 mg/kg v obliki disperzibilnih tablet) in močnega induktorja UGT rifampicina (v ponavljajočih se odmerkih po 600 mg/dan) povzročila zmanjšano izpostavljenost deferasiroksu za 44 % (90% IZ: 37 % - 51 %).
Do not use any pack that is damaged or shows signs of tampering.
Zdravila ne uporabljajte, če je ovojnina poškodovana ali opazite, da je bila že odprta.
BOTTLE LABEL
NALEPKA NA PLASTENKI
Caution should be taken during chelation therapy to minimise the risk of over-chelation in all patients (see section 4.4).
Pri vseh bolnikih je pri terapiji s kelacijo železa potrebna previdnost, da se čim bolj zmanjša tveganje za prekomerno kelacijo (glejte poglavje 4.4).
Other medicines and Deferasirox Mylan
Druga zdravila in zdravilo Deferasiroks Mylan
Transfusional iron overload
Preobremenitev z železom zaradi transfuzij
The active substance is deferasirox.
Zdravilna učinkovina je deferasiroks.
Diarrhoea, constipation, vomiting, nausea, abdominal pain, abdominal distension, dyspepsia
diareja, zaprtost, bruhanje, navzea, bolečina v trebuhu, napenjanje v trebuhu, dispepsija občasni:
Treatment may be reinitiated depending on the individual clinical circumstances.
Glede na klinično stanje posameznika se lahko zdravljenje ponovno uvede.