FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with non-transfusion-dependent thalassaemia syndromes and iron overload, treatment with deferasirox dispersible tablets was assessed in a 1-year, randomised, double-blind, placebo-controlled study.
Slovenian: Pri bolnikih s katerim od sindromov talasemije, neodvisnim od transfuzij, in preobremenitvijo z železom, so ocenjevali zdravljenje z deferasiroksom v obliki disperzibilnih tablet v enoletni, randomizirani, dvojno slepi, s placebom kontrolirani študiji.
English: The patient information pack should contain:
Slovenian: Paket izobraževalnih gradiv za bolnike mora vsebovati:
English: Acute renal failure
Slovenian: akutna ledvična odpoved
English: Deferasirox Mylan 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).
Slovenian: Pri bolnikih z okvaro ledvic uporaba zdravila Deferasiroks Mylan ni proučena in je kontraindicirana pri bolnikih z oceno očistka kreatinina <60 ml/min (glejte poglavji 4.3 in 4.4).
English: Decreases in mean creatinine clearance have been observed in both paediatric and adult patients with beta-thalassemia and iron overload during the first year of treatment, but there is evidence that this does not decrease further in subsequent years of treatment.
Slovenian: V prvem letu zdravljenja so tako pri pediatričnih kot pri odraslih bolnikih z beta talasemijo in s preobremenitvijo z železom opažali zmanjšanje povprečne vrednosti očistka kreatinina, vendar se po podatkih te vrednosti v nadaljnjih letih zdravljenja ne zmanjšujejo več.
English: Deferasirox has been studied only in patients with baseline serum creatinine within the ageappropriate normal range.
Slovenian: Deferasiroks je bil proučen samo pri bolnikih z izhodiščno koncentracijo kreatinina v serumu v okviru starostno ustreznih normalnih vrednosti.
English: The availability of long-term efficacy and safety data from clinical studies conducted with deferasirox dispersible tablets used at doses above 30 mg/kg is currently limited (264 patients followed for an average of 1 year after dose escalation).
Slovenian: Zaenkrat še ni na voljo veliko podatkov iz izvedenih kliničnih študij o dolgoročni učinkovitosti in varnosti deferasiroksa v obliki disperzibilnih tablet v odmerkih nad 30 mg/kg (264 bolnikov so spremljali povprečno 1 leto po postopnem zviševanju odmerka).
English: Patient guide should contain the following key elements: ◦ Information on the need for regular monitoring, and when it should be carried out, of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin ◦ Information that renal biopsy may be considered if significant renal abnormalities occur ◦ Availability of several oral formulations (e.g. dispersible tablets, film-coated tablets and granules) and the main differences associated with these formulations (i.e., different posology regimen, different conditions of administration notably with food)
Slovenian: Vodnik za bolnika mora vsebovati naslednje ključne vsebine: o podatke o potrebnosti rednega spremljanja in časovni razpored preiskav koncentracije kreatinina v serumu, očistka kreatinina, proteinurije, vrednosti jetrnih encimov in feritina, o obvestilo o možnosti, da je v primeru pojava pomembnih ledvičnih nepravilnosti treba razmisliti o ledvični biopsiji, o podatke o več različnih peroralnih formulacijah zdravil, ki vsebujejo deferasiroks (npr. disperzibilnih tabletah, filmsko obloženih tabletah in zrncih) in so na voljo, ter glavne razlike med temi formulacijami (to sta različen režim odmerjanja in različni pogoji jemanja, zlasti kar zadeva jemanje skupaj s hrano).
English: • The need to monitor serum ferritin monthly
Slovenian: • potrebo po mesečnem spremljanju feritina v serumu;
English: A food-effect study involving administration of the film-coated tablets to healthy volunteers under fasting conditions and with a low-fat (fat content <10% of calories) or high-fat (fat content >50% of calories) meal indicated that the AUC and Cmax were slightly decreased after a low-fat meal (by 11% and 16%, respectively).
Slovenian: V študiji vpliva sočasnega uživanja hrane s filmsko obloženimi tabletami pri zdravih prostovoljcih, ki so zdravilo zaužili na tešče, z obrokom z nizko vsebnostjo maščob (vsebnost maščob <10 % kalorij) ali z obrokom z visoko vsebnostjo maščob (vsebnost maščob >50 % kalorij), se je pokazalo, da sta vrednosti AUC in Cmax nekoliko nižji po zaužitju obroka z nizko vsebnostjo maščob (za 11 % oziroma 16 %).
English: In patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over time, mainly due to increased absorption of dietary iron in response to low blood cell counts.
Slovenian: Tudi pri bolnikih, ki imajo katerega od sindromov talasemije, ki niso posledica transfuzij, lahko sčasoma pride do preobremenitve z železom, predvsem zaradi povečane absorpcije železa iz prehrane, kar je odziv telesa na znižano število krvnih celic.
English: This is because blood contains iron and your body does not have a natural way to remove the excess iron you get with your blood transfusions.
Slovenian: Kri namreč vsebuje železo, presežno železo, ki ga dobite s transfuzijami krvi, pa se iz vašega telesa ne more odstraniti po naravni poti.
English: • Proteinuria (test should be performed prior to therapy and monthly thereafter)
Slovenian: pri proteinuriji (preiskavo je treba izvesti pred začetkom zdravljenja, nato pa enkrat na mesec),
English: It appeared from preclinical and clinical studies that deferasirox dispersible tablets could be as active as deferoxamine when used in a dose ratio of 2:1 (i.e. a dose of deferasirox dispersible tablets that is numerically half of the deferoxamine dose).
Slovenian: Na osnovi predkliničnih in kliničnih študij je postalo razvidno, da je deferasiroks v obliki disperzibilnih tablet lahko prav tako učinkovit kot deferoksamin, če se ga uporablja v razmerju odmerkov 2:1 (to je odmerek deferasiroksa v obliki disperzibilnih tablet, ki je številčno enak polovici odmerka deferoksamina).
English: It is recommended that treatment be started after the transfusion of approximately 20 units (about 100 ml/kg) of packed red blood cells (PRBC) or when there is evidence from clinical monitoring that chronic iron overload is present (e.g. serum ferritin >1,000 µg/l).
Slovenian: 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. vrednosti feritina v serumu >1.000 µg/l).
English: Also, there have been reports of fatal gastrointestinal haemorrhages, especially in elderly patients who had haematological malignancies and/or low platelet counts.
Slovenian: Obstajajo tudi poročila o gastrointestinalnih krvavitvah, ki so se končale s smrtjo, zlasti pri starejših bolnikih s hematološko maligno boleznijo in/ali z znižano koncentracijo trombocitov.
English: Hepatic and renal disorders have been reported, including cases of liver enzyme and creatinine increased with recovery after treatment discontinuation.
Slovenian: Poročali so o motenem delovanju jeter in ledvic, vključno s primeri zvišanih vrednosti jetrnih encimov in kreatinina, ki so se normalizirale po prekinitvi zdravljenja.
English: How to store Deferasirox Mylan Contents of the pack and other information
Slovenian: Shranjevanje zdravila Deferasiroks Mylan Vsebina pakiranja in dodatne informacije
English: Deferasirox Mylan 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).
Slovenian: Filmsko obložene tablete zdravila Deferasiroks Mylan je mogoče jemati bodisi na prazen želodec ali z lahkim obrokom, najbolje vsak dan ob istem času (glejte poglavji 4.2 in 5.2).
English: As a precaution, it is recommended that Deferasirox Mylan is not used during pregnancy unless clearly necessary.
Slovenian: Iz varnostnih razlogov je priporočljivo, da se zdravila Deferasiroks Mylan med nosečnostjo ne uporablja, razen če je to nujno potrebno.
English: There is no specific antidote for deferasirox.
Slovenian: Za deferasiroks ni specifičnega antidota.
English: How much Deferasirox Mylan to take The dose of Deferasirox Mylan is related to body weight for all patients.
Slovenian: Koliko zdravila Deferasiroks Mylan vzeti Odmerek zdravila Deferasiroks Mylan je pri vseh bolnikih odvisen od telesne mase.
English: No such effects were observed in iron-preloaded rats.
Slovenian: Takih učinkov pa ni bilo pri podganah, ki so bile predhodno obremenjene z železom.
English: The study compared the efficacy of two different deferasirox dispersible tablet regimens (starting doses of 5 and 10 mg/kg/day, 55 patients in each arm) and of matching placebo (56 patients).
Slovenian: Študija je primerjala učinkovitost dveh različnih shem zdravljenja z deferasiroksom v obliki disperzibilnih tablet (začetni odmerki so bili 5 in 10 mg/kg/dan, v vsaki skupini pa je bilo 55 bolnikov) ter primerjalno s placebom (56 bolnikov).
English: • The need for a guidance table highlighting pre-treatment measurements of serum creatinine, creatinine clearance, proteinuria, hepatic enzymes, ferritin, such as:
Slovenian: • potreba po vodenju in upoštevanju preglednice, ki opozarja na naslednje meritve pred zdravljenjem: koncentracije kreatinina v serumu, očistka kreatinina, proteinurije ter vrednosti jetrnih encimov in feritina, kot je prikazano:
English: Doses above 14 mg/kg are not recommended because there is no experience with doses above this level in patients with non-transfusion-dependent thalassaemia syndromes.
Slovenian: Uporaba odmerkov nad 14 mg/kg ni priporočljiva, saj z odmerki, ki presegajo navedeno vrednost, ni nobenih izkušenj pri bolnikih, ki imajo katerega od sindromov talasemije, neodvisnih od transfuzij.
English: For patients, already well managed on treatment with deferoxamine, a starting dose of Deferasirox Mylan 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 Deferasirox Mylan film-coated tablets).
Slovenian: Pri bolnikih, ki so ob zdravljenju z deferoksaminom že dobro urejeni, je lahko primeren začetni odmerek zdravila Deferasiroks Mylan 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 Deferasiroks Mylan v obliki filmsko obloženih tablet).
English: This includes in particular: - other iron chelators, which must not be taken with Deferasirox Mylan, - antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as Deferasirox Mylan,
Slovenian: To vključuje še posebno: - druge kelatorje železa, ki se jih ne sme jemati sočasno z zdravilom Deferasiroks Mylan, - antacide (zdravila za lajšanje težav pri zgagi), ki vsebujejo aluminij in se jih ne sme jemati istočasno kot zdravilo Deferasiroks Mylan, - ciklosporin (za preprečevanje zavrnitve presajenega organa in za zdravljenje drugih bolezni,
English: If such reactions occur, Deferasirox Mylan should be discontinued and appropriate medical intervention instituted.
Slovenian: V primeru takih reakcij je treba zdravljenje z zdravilom Deferasiroks Mylan prekiniti in ustrezno strokovno ukrepati.
English: Diarrhoea is reported more commonly in paediatric patients aged 2 to 5 years and in the elderly.
Slovenian: O diareji poročajo pogosteje pri pediatričnih bolnikih starih od 2 do 5 let in pri starejših.
English: • If you get blurred or cloudy eyesight,
Slovenian: • če vaš vid postane nejasen ali zamegljen,
English: All references to the dispersible tablet formulation throughout the SmPC refer to the reference medical product dispersible tablets.
Slovenian: Vse informacije, ki se tekom SmPC nanašajo na disperzibilne tablete, se nanašajo na referenčno zdravilo v obliki disperzibilne tablete.
English: Deferasirox is highly (99%) protein bound to plasma proteins, almost exclusively serum albumin, and has a small volume of distribution of approximately 14 litres in adults.
Slovenian: Deferasiroks se v veliki meri (99 %) veže na proteine v plazmi, skoraj izključno na serumske albumine.
English: After adjustment of the strength, the film-coated tablet formulation (360 mg strength) was equivalent to deferasirox dispersible tablets (500 mg strength) with respect to the mean area under the plasma concentration time curve (AUC) under fasting conditions.
Slovenian: Po prilagoditvi jakosti je formulacija filmsko obložene tablete (v jakosti 360 mg) enakovredna deferasiroksu v obliki disperzibilnih tablet (v jakosti 500 mg) glede povprečne površine pod krivuljo, ki prikazuje odvisnost plazemske koncentracije od časa (AUC) v pogojih na tešče.
English: Serum creatinine, creatinine clearance (estimated with the Cockcroft-Gault or MDRD formula in adults and with the Schwartz formula in children) and/or plasma cystatin C levels should be monitored prior to therapy, weekly in the first month after initiation or modification of therapy with deferasirox (including switch of formulation), and monthly thereafter.
Slovenian: Koncentracijo kreatinina v serumu, očistek kreatinina (ocenjen po Cockcroft-Gaultovi ali MDRD formuli pri odraslih in po Schwartzovi formuli pri otrocih) in/ali vrednost cistatina C v serumu je treba najprej določiti pred začetkom zdravljenja, v prvem mesecu po uvedbi ali spremembi zdravljenja z deferasiroksom (kar vključuje tudi prehod z uporabe ene formulacije zdravila na uporabo druge) jo je treba spremljati tedensko, kasneje pa enkrat mesečno.
English: Renal excretion of deferasirox and its metabolites is minimal (8% of the dose).
Slovenian: Izločanje deferasiroksa in njegovih presnovkov skozi ledvice je le minimalno (8 % odmerka).
English: These were dose-dependent.
Slovenian: Ta zvišanja so bila odvisna od odmerka.
English: Particular attention should therefore be paid to monitoring of serum creatinine in patients who are concomitantly receiving medicinal products that depress renal function, and in patients who are receiving high doses of deferasirox and/or low rates of transfusion (<7 ml/kg/month of packed red blood cells or <2 units/month for an adult).
Slovenian: Zato je treba posebej pozorno spremljati koncentracijo kreatinina v serumu pri tistih bolnikih, ki sočasno prejemajo zdravila, ki zmanjšujejo delovanje ledvic, in pri tistih, ki prejemajo visoke odmerke deferasiroksa in/ali transfuzije z majhno intenzivnostjo (<7 ml/kg/mesec koncentriranih eritrocitov ali <2 enoti/mesec pri odraslem).
English: • The importance of measuring creatinine clearance • Brief overview of methods of measuring creatinine clearance
Slovenian: • kratek pregled metod merjenja očistka kreatinina;
English: • Low urine output
Slovenian: • zmanjšano izločanje urina
English: While no increase in renal adverse events was observed after dose escalation of deferasirox 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.
Slovenian: Čeprav v kliničnih študijah deferasiroksa 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.
English: Deferasirox Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Slovenian: Zdravilo Deferasiroks Mylan vsebuje manj kot 1 mmol natrija (23 mg) na tableto, kar v bistvu pomeni ‘brez natrija'.
English: Deconjugation of glucuronidates in the intestine and subsequent reabsorption (enterohepatic recycling) is likely to occur: in a healthy volunteer study, the administration of cholestyramine after a single dose of deferasirox resulted in a 45% decrease in deferasirox exposure (AUC).
Slovenian: Z veliko verjetnostjo se glukuronidi v črevesu dekonjugirajo in nato ponovno absorbirajo (enterohepatična cirkulacija): v študiji pri zdravih prostovoljcih je uporaba holestiramina po enkratnem odmerku deferasiroksa povzročila 45-odstotno zmanjšanje izpostavljenosti deferasiroksu (AUC).
English: Treatment with Deferasirox Mylan will be overseen by a doctor who is experienced in the treatment of iron overload caused by blood transfusions.
Slovenian: Zdravljenje z zdravilom Deferasiroks Mylan bo nadzoroval zdravnik z izkušnjami z zdravljenem preobremenitve z železom zaradi krvnih transfuzij.
English: Clinical study in patients with non-transfusion-dependent thalassaemia syndromes
Slovenian: Klinične študije pri bolnikih s sindromi talasemije, neodvisnimi od transfuzij
English: Severe forms associated with changes in consciousness in the context of hyperammonaemic encephalopathy have been reported.
Slovenian: Poročali so o hudih oblikah v povezavi z motnjami zavesti v okviru hiperamoniemične encefalopatije.
English: Do not store it for future use.
Slovenian: Tako pripravljenega odmerka ne smete shranjevati za kasnejšo uporabo.
English: 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.
Slovenian: V primeru prehoda z disperzibilnih tablet na filmsko obložene tablete, mora biti odmerek pri filmsko obloženih tabletah 30% nižji od prejšnjega odmerka v obliki disperzibilnih tablet, in sicer naj bo odmerek zaokrožen na najbližjo jakost cele tablete.
English: Blood disorders
Slovenian: Bolezni krvi
English: • 28 mg per kilogram body weight for patients receiving regular blood transfusions,
Slovenian: • 28 mg na kilogram telesne mase za bolnike, ki prejemajo redne transfuzije krvi,
English: • A decrease in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (anaemia aggravated), in the number of white blood cells (neutropenia) or in the number of all kinds of blood cells (pancytopenia)
Slovenian: • zmanjšano število celic, ki so pomembne za strjevanje krvi, (trombocitopenija), zmanjšano število rdečih krvnih celic (poslabšanje anemije), zmanjšano število belih krvnih celic
English: During clinical studies dose-dependent increases in serum creatinine occurred in about 36% of patients, though most remained within the normal range.
Slovenian: V kliničnih študijah je pri približno 36 % bolnikov prišlo do od odmerka odvisnega zvišanja koncentracije kreatinina v serumu, čeprav je ta večinoma ostala v mejah normalnih vrednosti.
English: Elevations of liver transaminases greater than 2 times the baseline and 5 times the upper limit of normal were reported in 1.8% of patients.
Slovenian: O zvišanih vrednostih jetrnih aminotransferaz, ki so presegale 2-kratnik izhodiščne vrednosti in 5-kratnik zgornje meje normalnih vrednosti, so poročali pri 1,8 % bolnikov.
English: Deferasirox induced similar responses in iron-overloaded patients with other anaemias.
Slovenian: Deferasiroks je povzročil podobne odzive tudi pri bolnikih z drugimi anemijami in s preobremenitvijo z železom.
English: Cataract, maculopathy
Slovenian: katarakta, makulopatija redki:
English: 1, renal tubular necrosis General disorders and administration site conditions Uncommon:
Slovenian: 1, renalna tubularna nekroza Splošne težave in spremembe na mestu aplikacije občasni:
English: When interruption of treatment may be necessary, treatment may be reintroduced after resolution of the rash, at a lower dose followed by gradual dose escalation.
Slovenian: Če je treba zdravljenje prekiniti, je po izginotju izpuščaja mogoče ponovno uvesti zdravljenje z nižjim odmerkom in kasnejšim postopnim zviševanjem odmerka.
English: Characteristics in patients
Slovenian: Posebnosti pri bolnikih
English: Caution should be used in elderly patients due to a higher frequency of adverse reactions (in particular, diarrhoea).
Slovenian: Pri starejših bolnikih je potrebna previdnost zaradi pogostejših neželenih učinkov (zlasti zaradi diareje).
English: In two clinical studies, growth and sexual development of paediatric patients treated with deferasirox for up to 5 years were not affected (see section 4.8).
Slovenian: V dveh kliničnih študijah rast in spolno dozorevanje pediatričnih bolnikov, zdravljenih z deferasiroksom do 5 let, nista bila motena (glejte poglavje 4.8).
English: Bioavailability of deferasirox film-coated tablets was 36% greater than that with dispersible tablets.
Slovenian: Biološka uporabnost deferasiroksa v obliki filmsko obloženih tablet je bila za 36 % večja kot pri disperzibilnih tabletah.
English: White HDPE bottle with white opaque polypropylene (PP) screw cap with aluminum seal containing 90 or 300 film-coated tablets.
Slovenian: Bela HDPE plastenka z belim netransparentnim polipropilenskim (PP) zamaškom z aluminijasto zaporko, ki vsebuje 90 ali 300 filmsko obloženih tablet.
English: • Description of available deferasirox formulations on the market (e.g. dispersible tablets, filmcoated tablets and granules) ◦ Different posology regimen ◦ Different conditions of administration ◦ Dose conversion table when switching from one formulation to another
Slovenian: • opis formulacij zdravila, ki vsebujejo deferasiroks (npr. disperzibilnih tablet, filmsko obloženih tablet in zrnc), ki so na voljo o različne režime odmerjanja o različne pogoje jemanja o preglednico za pretvorbo višine odmerkov pri prehodu z ene formulacije na drugo
English: Taking Deferasirox Mylan at the same time each day will also help you remember when to take your tablets.
Slovenian: Če boste jemali tablete zdravila Deferasiroks Mylan vsak dan ob istem času, tudi ne boste pozabili, kdaj jih morate vzeti.
English: The other ingredients are microcrystalline cellulose, crospovidone, povidone, magnesium stearate, colloidal anhydrous silica and poloxamer.
Slovenian: Druge sestavine zdravila so mikrokristalna celuloza, krospovidon, povidon, magnezijev stearat, brezvoden koloidni silicijev dioksid, poloksamer.
English: Elderly patients may experience more side effects (in particular diarrhoea) than younger patients.
Slovenian: Pri starejših bolnikih lahko pogosteje pride do neželenih učinkov (zlasti driske) kot pri mlajših bolnikih.
English: The majority of these patients had renal impairment, renal tubulopathy (Fanconi syndrome) or diarrhoea, or conditions where acid-base imbalance is a known complication.
Slovenian: Večina teh bolnikov je imela okvaro ledvic, renalno tubulopatijo (Fanconijev sindrom), diarejo ali stanja, pri katerih je nastanek kislinsko-baznega neravnovesja znan zaplet.
English: Deferasirox and its metabolites are primarily excreted in the faeces (84% of the dose).
Slovenian: Deferasiroks in njegovi presnovki se pretežno izločajo z blatom (84 % odmerka).
English: If serum ferritin falls consistently below 500 µg/l (in transfusional iron overload) or below 300 µg/l (in non-transfusion-dependent thalassaemia syndromes), an interruption of treatment should be considered.
Slovenian: Če vrednosti feritina v serumu večkrat padejo pod 500 µg/l (če gre za preobremenitev z železom zaradi transfuzij) oziroma pod 300 µg/l (pri sindromih talasemije, neodvisnih od transfuzij), je treba razmisliti o prekinitvi zdravljenja.
English: • The rules for treatment dose adjustments and interruption when target serum ferritin +/− liver iron concentration are reached.
Slovenian: • pravila za prilagajanje odmerka in prekinitev zdravljenja, kadar je dosežena ciljna koncentracija feritina v serumu skupaj z doseženo ciljno koncentracijo železa v jetrih ali brez nje;
English: No clinical data on exposed pregnancies are available for deferasirox.
Slovenian: Za deferasiroks ni na voljo kliničnih podatkov nosečnic, ki so bile izpostavljene zdravilu.
English: The pharmacokinetics of deferasirox have not been studied in patients with renal impairment.
Slovenian: Farmakokinetika deferasiroksa pri bolnikih z okvaro ledvic ni bila proučena.