FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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),
Slovenian: 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),
English: Acidbase balance should be monitored as clinically indicated in these populations.
Slovenian: Pri navedenih skupinah bolnikov je potreben nadzor kislinsko-baznega ravnovesja v skladu s kliničnimi indikacijami.
English: • Disturbance in kidney function tests.
Slovenian: • nepravilnosti v izvidih preiskav delovanja ledvic.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: LIC is the preferred method of iron overload determination and should be used wherever available.
Slovenian: Merjenje koncentracije železa v jetrih je metoda izbora pri določanju preobremenitve z železom in jo je treba uporabljati, če je le na razpolago.
English: Renal tubulopathy has been mainly reported in children and adolescents with beta-thalassaemia treated with deferasirox.
Slovenian: O renalni tubulopatiji so poročali večinoma pri otrocih in mladostnikih, ki so deferasiroks prejemali zaradi beta talasemije.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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,
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: • Severe upper stomach pain (pancreatitis)
Slovenian: • hude bolečine v zgornjem delu trebuha (vnetje trebušne slinavke)
English: 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.
Slovenian: 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 %).
English: After dose reduction, interrupt treatment, if Adult and paediatric Remains >33% above pre-treatment average and/or Decreases <LLN
Slovenian: 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)
English: In addition to monthly serum ferritin assessments, LIC should be monitored every three months when serum ferritin is ≤800 µg/l.
Slovenian: 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.
English: Exposure was increased 2.8-fold in one subject with severe hepatic impairment (Child-Pugh Class C) (see sections 4.2 and 4.4).
Slovenian: Pri enem bolniku s hudo okvaro jeter (Child-Pugh stopnje C) je bila izpostavljenost 2,8krat večja (glejte poglavji 4.2 in 4.4).
English: Blood and lymphatic system disorders Not known:
Slovenian: Bolezni krvi in limfatičnega sistema neznana pogostnost:
English: What Deferasirox Mylan looks like and contents of the pack Deferasirox Mylan is supplied as film-coated tablets.
Slovenian: Izgled zdravila Deferasiroks Mylan in vsebina pakiranja Zdravilo Deferasiroks Mylan je na voljo v obliki filmsko obloženih tablet.
English: Auditory (decreased hearing) and ocular (lens opacities) disturbances are uncommon, and yearly examinations are also recommended (see section 4.4).
Slovenian: Občasno pride do težav s sluhom (slabšanje sluha) in vidom (motnjave leče), zato so priporočeni vsakoletni pregledi (glejte poglavje 4.4).
English: Deferasirox Mylan is not recommended during pregnancy unless clearly necessary.
Slovenian: Uporaba zdravila Deferasiroks Mylan med nosečnostjo ni priporočljiva, če ni nujno potrebno.
English: If you miss a dose, take it as soon as you remember on that day.
Slovenian: Če ste pozabili vzeti zdravilo Deferasiroks Mylan Če ste pozabili vzeti odmerek, ga vzemite isti dan, takoj ko se spomnite.
English: 21 mg/kg/day
Slovenian: 21 mg/kg/dan
English: Do not stop taking Deferasirox Mylan unless your doctor tells you to.
Slovenian: Če ste prenehali jemati zdravilo Deferasiroks Mylan Ne prenehajte jemati zdravila Deferasiroks Mylan, če vam tega ne naroči zdravnik.
English: 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.
Slovenian: 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).
English: The pharmacokinetics of deferasirox were not influenced by liver transaminase levels up to 5 times the upper limit of the normal range.
Slovenian: Vrednosti jetrnih transaminaz do 5-kratnika zgornje meje normalnega okvira niso vplivale na farmakokinetiko deferasiroksa.
English: 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%).
Slovenian: 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 %).
English: • If you experience frequent heartburn,
Slovenian: • če vas pogosto muči zgaga,
English: 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%).
Slovenian: 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 %).
English: Do not use any pack that is damaged or shows signs of tampering.
Slovenian: Zdravila ne uporabljajte, če je ovojnina poškodovana ali opazite, da je bila že odprta.
English: BOTTLE LABEL
Slovenian: NALEPKA NA PLASTENKI
English: Caution should be taken during chelation therapy to minimise the risk of over-chelation in all patients (see section 4.4).
Slovenian: Pri vseh bolnikih je pri terapiji s kelacijo železa potrebna previdnost, da se čim bolj zmanjša tveganje za prekomerno kelacijo (glejte poglavje 4.4).
English: Other medicines and Deferasirox Mylan
Slovenian: Druga zdravila in zdravilo Deferasiroks Mylan
English: Transfusional iron overload
Slovenian: Preobremenitev z železom zaradi transfuzij
English: The active substance is deferasirox.
Slovenian: Zdravilna učinkovina je deferasiroks.
English: Diarrhoea, constipation, vomiting, nausea, abdominal pain, abdominal distension, dyspepsia
Slovenian: diareja, zaprtost, bruhanje, navzea, bolečina v trebuhu, napenjanje v trebuhu, dispepsija občasni:
English: Treatment may be reinitiated depending on the individual clinical circumstances.
Slovenian: Glede na klinično stanje posameznika se lahko zdravljenje ponovno uvede.
English: - ciclosporin (used to prevent the body rejecting a transplanted organ or for other conditions, such as rheumatoid arthritis or atopic dermatitis), - simvastatin (used to lower cholesterol), - certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids), - oral bisphosphonates (used to treat osteoporosis), - anticoagulant medicines (used to prevent or treat blood clotting), - hormonal contraceptive agents (birth control medicines), - bepridil, ergotamine (used for heart problems and migraines), - repaglinide (used to treat diabetes), - rifampicin (used to treat tuberculosis), - phenytoin, phenobarbital, carbamazepine (used to treat epilepsy), - ritonavir (used in the treatment of HIV infection), - paclitaxel (used in cancer treatment), - theophylline (used to treat respiratory diseases such as asthma), - clozapine (used to treat psychiatric disorders such as schizophrenia), - tizanidine (used as a muscle relaxant), - cholestyramine (used to lower cholesterol levels in the blood).
Slovenian: - fenitoin, fenobarbital, karbamazepin (za zdravljenje epilepsije), - ritonavir (za zdravljenje okužbe s HIV), - paklitaksel (za zdravljenje raka), - teofilin (za zdravljenje bolezni dihal, kot je astma), - klozapin (za zdravljenje psihiatričnih motenj, kot je shizofrenija), - tizanidin (mišični relaksant), - holestiramin (za zniževanje ravni holesterola v krvi), - busulfan (zdravilo, ki se uporablja pred presaditvijo za uničenje bolnikovega kostnega mozga pred prejemom presadka).
English: Deferasirox did not cause other effects on fertility or reproduction.
Slovenian: Drugih učinkov na plodnost ali sposobnost razmnoževanja deferasiroks ni povzročil.
English: - if you have a low level of platelets or white blood cells in your blood test. - if you have blurred vision - if you have diarrhoea or vomiting.
Slovenian: Mylan, - če vas pogosto muči zgaga, - če vam preiskava krvi pokaže znižano koncentracijo trombocitov ali levkocitov, - če imate zamegljen vid, - če imate drisko ali bruhate.
English: Interaction with theophylline and other agents metabolised by CYP1A2
Slovenian: Medsebojno delovanje s teofilinom in drugimi zdravili, katerih presnova poteka s CYP1A2
English: The Cmax of deferasirox film-coated tablets was increased (by 29%) when taken with a high-fat meal.
Slovenian: Pri jemanju deferaksiroksa v obliki filmsko obloženih tablet skupaj z obrokom z visoko vsebnostjo maščob se je njegova Cmax zvišala (za 29 %).
English: - if you are currently taking any other iron chelator medicines.
Slovenian: - če imate zmerno ali hudo bolezen ledvic, - če trenutno jemljete katero koli drugo zdravilo, ki kelira železo.
English: Agents that may decrease Deferasirox Mylan systemic exposure
Slovenian: Zdravila, ki lahko zmanjšajo sistemsko izpostavljenost zdravilu Deferasiroks Mylan
English: Gastrointestinal haemorrhage, gastric ulcer (including multiple ulcers), duodenal ulcer, gastritis
Slovenian: gastrointestinalne krvavitve, želodčni ulkus (vključno s številnimi ulkusi), ulkus dvanajstnika, vnetje želodčne sluznice redki:
English: If this applies to you, tell your doctor before taking Deferasirox Mylan.
Slovenian: Če to velja za vas, obvestite o tem svojega zdravnika še pred jemanjem zdravila
English: 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.
Slovenian: V študiji pri zdravih prostovoljcih je sočasna uporaba deferasiroksa kot zmernega zaviralca CYP2C8 (v odmerku 30 mg/kg dnevno v obliki disperzibilnih tablet) in repaglinida, substrata CYP2C8, danega v enkratnem odmerku 0,5 mg, povečala AUC repaglinida za približno 2,3-krat (90% IZ: [2,03-2,63]) in zvišala njegovo Cmax za približno 1,6-krat (90% IZ [1,42-1,84]).
English: Cholestyramine significantly reduced the deferasirox exposure in a mechanistic study to determine the degree of enterohepatic recycling (see section 5.2).
Slovenian: V mehanistični študiji za določanje stopnje enterohepatičnega kroženja je holestiramin pomembno znižal izpostavljenost deferasiroksu (glejte poglavje 5.2).
English: As a consequence, treatment with Deferasirox Mylan is not recommended in these patients.
Slovenian: Iz tega razloga pri navedenih bolnikih zdravljenje z zdravilom Deferasiroks Mylan ni priporočeno.
English: Deferasirox should not be reintroduced in patients who have experienced a hypersensitivity reaction due to the risk of anaphylactic shock (see section 4.3).
Slovenian: Pri bolnikih, pri katerih se je pojavila preobčutljivostna reakcija, se deferasiroksa ne sme ponovno uvesti zaradi tveganja za nastanek anafilaktičnega šoka (glejte poglavje
English: 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%).
Slovenian: 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 %).
English: Auditory (decreased hearing) and ocular (lens opacities) disturbances have been reported (see section 4.8).
Slovenian: Poročali so o motnjah sluha (slabši sluh) in vida (motnjava leče) (glejte poglavje 4.8).
English: It is recommended that serum creatinine be assessed in duplicate before initiating therapy.
Slovenian: Pred uvedbo zdravljenja je priporočljivo dvakrat oceniti koncentracijo kreatinina v serumu.
English: • Anxiety
Slovenian: • utrujenost
English: Breast-feeding while taking Deferasirox Mylan is not recommended.
Slovenian: Dojenje v času jemanja zdravila Deferasiroks Mylan ni priporočljivo.
English: For patients in whom the dose was increased to >7 mg/kg, dose reduction to 7 mg/kg or less is recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l.
Slovenian: Bolnikom, ki ste jim odmerek zvišali na >7 mg/kg, je priporočljivo odmerek znižati na 7 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.
English: These side effects are uncommon.
Slovenian: Ti neželeni učinki se pojavljajo občasno.
English: Continue taking Deferasirox Mylan every day for as long as your doctor tells you.
Slovenian: Kako dolgo jemati zdravilo Deferasiroks Mylan Z vsakodnevnim jemanjem zdravila Deferasiroks Mylan nadaljujte tako dolgo, kot vam je naročil vaš zdravnik.
English: Glucuronidation is the main metabolic pathway for deferasirox, with subsequent biliary excretion.
Slovenian: Glavna metabolična pot deferasiroksa je glukuronidacija, ki ji sledi izločanje z žolčem.
English: If any of these affects you severely, tell your doctor.
Slovenian: Če imate s katerim koli od navedenih učinkov resne težave, obvestite svojega zdravnika.
English: 7 mg/kg/day
Slovenian: 7 mg/kg/dan
English: Post-marketing cases of severe forms of renal tubulopathy (such as Fanconi syndrome) and renal failure associated with changes in consciousness in the context of hyperammonaemic encephalopathy have been reported in patients treated with deferasirox, mainly in children.
Slovenian: V obdobju trženja zdravila so pri bolnikih, ki so prejemali deferasiroks, zlasti pri otrocih, poročali o primerih hudih oblik renalne tubulopatije (kot je Fanconijev sindrom) in ledvične odpovedi v povezavi z motnjami zavesti v okviru hiperamoniemične encefalopatije.
English: Medicines called iron chelators are used to remove the excess iron and reduce the risk of it causing organ damage.
Slovenian: Za odstranjevanje presežnega železa in zmanjševanje nevarnosti, da bi poškodovalo organe, uporabljamo zdravila, ki jih imenujemo kelatorji železa.
English: 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.
Slovenian: V kliničnih študijah je pri približno 36 % bolnikov prišlo do zvišanja koncentracije kreatinina v serumu za >33 % na dveh ali več zaporednih obiskih, nekajkrat preko zgornje meje normalnih vrednosti.
English: Deferasirox Mylan is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.
Slovenian: Zdravilo Deferasiroks Mylan je indicirano 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.
English: Deferasirox Mylan contains an active substance called deferasirox.
Slovenian: Zdravilo Deferasiroks Mylan vsebuje zdravilno učinkovino, ki jo imenujemo deferasiroks.
English: Deferasirox Mylan is also used to treat chronic iron overload when deferoxamine therapy is contraindicated or inadequate in patients with beta thalassaemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years.
Slovenian: Zdravilo Deferasiroks Mylan uporabljamo tudi za zdravljenje kronične preobremenitve z železom v primerih, ko je zdravljenje z deferoksaminom kontraindicirano ali neprimerno pri bolnikih z beta talasemijo major s preobremenitvijo z železom zaradi manj pogostih transfuzij krvi, pri bolnikih z drugimi vrstami slabokrvnosti in pri otrocih, starih od 2 do 5 let.
English: or >1,000μg/l
Slovenian: O ali >1.000μg/l druge možnosti začetnega odmerka
English: Deferasirox Mylan 360 mg
Slovenian: deferasiroks mylan 360 mg
English: Interruption of deferasirox therapy should be considered in patients who develop metabolic acidosis.
Slovenian: Pri bolnikih, pri katerih se pojavi metabolna acidoza je treba razmisliti o prekinitvi zdravljenja z deferasiroksom.
English: A comparable safety profile for film-coated and dispersible tablets was observed.
Slovenian: Pri uporabi filmsko obloženih tablet in disperzibilnih tablet so opažali primerljiv varnostni profil.
English: Common:
Slovenian: NN:
English: Deferasirox also comes as “dispersible” tablets.
Slovenian: Deferasiroks je na voljo tudi v obliki disperzibilnih tablet.
English: The patient's serum ferritin should be monitored during and after the combination, and the dose of Deferasirox Mylan adjusted if necessary.
Slovenian: V obdobju jemanja te kombinacije zdravil in še po njem je treba spremljati bolnikove vrednosti feritina v serumu in po potrebi prilagajati odmerek zdravila Deferasiroks Mylan.
English: There have been post-marketing reports of leukopenia, thrombocytopenia or pancytopenia (or aggravation of these cytopenias) and of aggravated anaemia in patients treated with deferasirox.
Slovenian: V obdobju trženja so pri bolnikih, ki so prejemali deferasiroks, poročali o levkopeniji, trombocitopeniji ali pancitopeniji (oziroma o poslabšanju navedenih citopenij) in o poslabšanju anemije.
English: Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years than in older patients.
Slovenian: Pri pediatričnih bolnikih, starih od 2 do 5 let, so pogosteje poročali o diareji kot pri starejših bolnikih.
English: 1, thrombocytopenia
Slovenian: 1, trombocitopenija
English: • Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating,
Slovenian: • prebavne težave, kot so slabost, bruhanje, driska, bolečine v trebuhu, napihnjen trebuh, zaprtje,