FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of deferasirox and busulfan resulted in an increase of busulfan exposure (AUC), but the mechanism of the interaction remains unclear.
Slovenian: Sočasna uporaba deferasiroksa z busulfanom je povečala izpostavljenost busulfanu (AUC), vendar ostaja mehanizem te interakcije nejasen.
English: Some side effects could become serious.
Slovenian: Nekateri neželeni učinki lahko postanejo resni.
English: If you stop taking it, the excess iron will no longer be removed from your body (see also above section “How long to take Deferasirox Mylan”).
Slovenian: Če zdravilo prenehate jemati, se presežek železa ne bo več izločal iz vašega telesa (glejte tudi poglavje zgoraj “Kako dolgo jemati zdravilo Deferasiroks Mylan”).
English: Safety monitoring schedules for renal and liver parameters are recommended.
Slovenian: Za spremljanje varnosti je priporočeno pripraviti razpored določanja ledvičnih in jetrnih parametrov.
English: Linearity / non-linearity
Slovenian: Linearnost / nelinearnost
English: , tubulointerstitial nephritis
Slovenian: , tubulointersticijski nefritis
English: • Change in the colour of the skin
Slovenian: • spremembe barve kože
English: Elderly patients (≥65 years of age)
Slovenian: Starejši bolniki (stari ≥65 let)
English: • If you vomit blood and/or have black stools,
Slovenian: • če bruhate kri in/ali imate črno blato,
English: As the patient grows the doctor will adjust the dose.
Slovenian: Z rastjo otroka zdravnik prilagaja odmerek.
English: If possible, evaluation of the pharmacokinetics (AUC, clearance) of a busulfan test dose should be performed to allow dose adjustment.
Slovenian: Če je mogoče, je treba izvesti oceno farmakokinetičnih parametrov (AUC, očistka) poskusnega odmerka busulfana za osnovo prilagajanja odmerka.
English: If you think you may be allergic, ask your doctor for advice.
Slovenian: Če mislite, da bi bili lahko alergični, se posvetujte s svojim zdravnikom.
English: This imbalance occurred because patients on deferoxamine were allowed to remain on their pre-study dose even if it was higher than the protocol specified dose.
Slovenian: Do te neuravnoteženosti je prišlo zato, ker so bolnikom, ki so že pred študijo jemali deferoksamin, dovolili obdržati enak odmerek v študiji, čeprav je bil višji kot ga je sicer določal protokol.
English: The Cmax was increased by 30% (90% CI: 20.3% - 40.0%); however a clinical exposure/response analysis revealed no evidence of clinically relevant effects of such an increase.
Slovenian: Cmax je sicer višja za 30 % (90-odstotni interval zaupanja: 20,3 % - 40,0 %), vendar rezultati analize klinične izpostavljenosti/odziva ne kažejo klinično pomembnih učinkov tega zvišanja.
English: Do not take a double dose on the next day to make up for the forgotten tablet(s).
Slovenian: Naslednjega dne ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto (oziroma prejšnje tablete).
English: The mean elimination half-life (t½) ranged from 8 to 16 hours.
Slovenian: Povprečen razpolovni čas izločanja (t1/2) je bil med 8 in 16 urami.
English: The causes of the rises in serum creatinine have not been elucidated.
Slovenian: Vzroki zviševanja koncentracije kreatinina v serumu še niso pojasnjeni.
English: In animal studies, deferasirox was found to be rapidly and extensively secreted into maternal milk.
Slovenian: V študijah na živalih se je pokazalo, da se deferasiroks hitro in v veliki meri izloča v materino mleko.
English: Of the paediatric patients 52 were aged 2 to 5 years.
Slovenian: Od pediatričnih bolnikov jih je bilo 52 starih od 2 do 5 let.
English: • Disturbance in urine test (protein in the urine) If any of these affects you severely, tell your doctor.
Slovenian: • nenormalen izvid preiskave urina (beljakovine v urinu) Če imate s katerim koli od navedenih učinkov resne težave, obvestite svojega zdravnika.
English: • If you experience severe upper stomach pain (pancreatitis), stop taking this medicine and tell your doctor straight away.
Slovenian: • če pride do hude bolečine v zgornjem delu trebuha (vnetje trebušne slinavke), prenehajte jemati to zdravilo in takoj obvestite svojega zdravnika.
English: Patients with estimated creatinine clearance <60 ml/min.
Slovenian: Bolniki z oceno očistka kreatinina <60 ml/min.
English: Mylan S.A.S 117 Allée des Parcs Saint-Priest 69800, France
Slovenian: Mylan S.A.S 117 Allée des Parcs Saint-Priest 69800, Francija
English: Do not take Deferasirox Mylan - if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Deferasiroks Mylan - če ste alergični na deferasiroks ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: You may also have MRI (magnetic resonance imaging) tests to determine the amount of iron in your liver.
Slovenian: Poleg tega boste morda opravili preiskavo z MR (magnetno resonančnim) slikanjem, s katero je mogoče določiti količino železa v vaših jetrih.
English: Deferasirox was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/− heterozygous mice in a 6-month study.
Slovenian: Deferasiroks ni bil karcinogen, ko so ga uporabili pri podganah v 2-letni študiji in transgenskih p53+/- heterozigotnih miših v 6-mesečni študiji.
English: Manufacturer Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Slovenian: Izdelovalec Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, Velika Britanija
English: If you have questions about how long to take Deferasirox Mylan, talk to your doctor.
Slovenian: Če imate vprašanja o tem, kako dolgo jemati zdravilo Deferasiroks Mylan, se pogovorite s svojim zdravnikom.
English: There are no data available on the retreatment of patients who reaccumulate iron after having achieved a satisfactory body iron level and therefore retreatment cannot be recommended.
Slovenian: O ponovnem zdravljenju bolnikov, pri katerih pride znova do kopičenja železa zatem, ko so dosegli zadovoljivo raven železa v telesu, ni nobenih podatkov, zato ponovnega zdravljenja ne priporočamo.
English: The safety of deferasirox in combination with other iron chelators has not been established.
Slovenian: Varnost uporabe deferasiroksa v kombinaciji z drugimi kelatorji železa ni bila ugotovljena.
English: An erroneously administered single dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment.
Slovenian: Pomotoma apliciran enkratni odmerek 90 mg/kg je povzročil Fanconijev sindrom, ki pa je po zdravljenju izzvenel.
English: Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3.
Slovenian: Glukuronidacija deferasiroksa poteka predvsem z UGT1A1, manj pa z UGT1A3.
English: Contraindicated
Slovenian: kontraindicirano
English: If deferasirox and theophylline are used concomitantly, monitoring of theophylline concentration and theophylline dose reduction should be considered.
Slovenian: Če se deferasiroks in teofilin uporabljata sočasno, je treba razmisliti o spremljanju koncentracije teofilina in znižanju odmerka teofilina.
English: If any of these apply to you, tell your doctor straight away.
Slovenian: Če karkoli od navedenega velja za vas, takoj obvestite svojega zdravnika.
English: The increases in Cmax due to the change in formulation and due to the effect of a high-fat meal may be additive and therefore, it is recommended that the film-coated tablets should be taken either on an empty stomach or with a light meal.
Slovenian: Zvišanje Cmax zaradi jemanja drugačne formulacije in zaradi vpliva obroka z visoko vsebnostjo maščob je lahko aditivno, zato je filmsko obložene tablete priporočljivo jemati bodisi na prazen želodec ali z lahkim obrokom.
English: In some post-marketing cases, renal function deterioration has led to renal failure requiring temporary or permanent dialysis.
Slovenian: V nekaterih primerih v obdobju trženja se je slabšanje ledvične funkcije končalo z ledvično odpovedjo, zaradi katere je bilo potrebno začasno ali stalno dializno zdravljenje.
English: • Tear in stomach or intestine wall that can be painful and cause nausea
Slovenian: • raztrganje stene želodca ali črevesa, ki je lahko zelo boleče in povzroči občutek slabosti
English: The rashes resolve spontaneously in most cases.
Slovenian: Izpuščaji večinoma spontano izzvenijo.
English: Hepatic function in all patients should be monitored before treatment, every 2 weeks during the first month and then every month (see section 4.4).
Slovenian: Pri vseh bolnikih je treba jetrno funkcijo izmeriti pred zdravljenjem, v prvem mesecu zdravljenja vsaka 2 tedna, nato pa jo spremljati vsak mesec (glejte poglavje 4.4).
English: Combination with other iron chelator therapies as the safety of such combinations has not been established (see section 4.5).
Slovenian: Kombinacija zdravljenja z drugimi kelatorji železa, saj varnost takih kombinacij ni bila ugotovljena (glejte poglavje 4.5).
English: The tests will also monitor your kidney function (blood level of creatinine, presence of protein in the urine) and liver function (blood level of transaminases).
Slovenian: Preiskave bodo pokazale tudi delovanje vaših ledvic (vrednost kreatinina v krvi, prisotnost proteinov v urinu) in jeter (vrednosti transaminaz v krvi).
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: • Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose.
Slovenian: • Glede na vaš odziv na zdravljenje vam bo zdravnik kasneje prilagodil zdravljenje in vam morda zvišal ali znižal odmerek.
English: The kidney toxicity is considered mainly due to iron deprivation in animals that were not previously overloaded with iron.
Slovenian: Menijo, da je do toksičnosti za ledvice prišlo predvsem zaradi pomanjkanja železa pri živalih, ki predhodno niso bile preobremenjene z železom.
English: These reactions are dosedependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is continued.
Slovenian: Ti učinki so odvisni od odmerka, večinoma so blagi do zmerni, v glavnem prehodnega značaja in večinoma izzvenijo tudi ob nadaljevanju zdravljenja.
English: Doses above 28 mg/kg are not recommended because there is only limited experience with doses above this level (see section 5.1).
Slovenian: Odmerki nad 28 mg/kg niso priporočljivi, saj so na voljo le omejene izkušnje z odmerki nad to vrednostjo (glejte poglavje 5.1).
English: Fifty-six patients under the age of 6 years participated in this pivotal study, 28 of them receiving deferasirox dispersible tablets.
Slovenian: V to ključno študijo je bilo vključenih 56 bolnikov mlajših od 6 let, od teh jih je 28 prejemalo deferasiroks v obliki disperzibilnih tablet.
English: Deferasirox metabolism depends on UGT enzymes.
Slovenian: Presnova deferasiroksa je odvisna od encimov UGT.
English: 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.
Slovenian: Namen terapije s kelacijo železa je odstraniti količino železa, ki je bila vnešena s transfuzijo, in po potrebi zmanjšati obstoječo obremenitev z železom.
English: Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Slovenian: Večinoma so ti neželeni učinki blagi do zmerni in izzvenijo v nekaj dneh do nekaj tednih zdravljenja.
English: These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people).
Slovenian: Ti neželeni učinki se pojavljajo občasno (lahko se pojavijo pri največ 1 od 100 ljudi) ali redko (lahko se pojavijo pri največ 1 od 1.000 ljudi).
English: Standard procedures for management of overdose may be indicated as well as symptomatic treatment, as medically appropriate.
Slovenian: Za zdravljenje v primeru prevelikega odmerjanja so lahko indicirani običajni ukrepi, pa tudi simptomatsko zdravljenje, če je medicinsko upravičeno.
English: Prior to launch of Deferasirox Mylan in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred prihodom zdravila Deferasiroks Mylan na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi ostalimi vidiki programa.
English: The absolute bioavailability (AUC) of deferasirox (dispersible tablet formulation) is about 70% compared to an intravenous dose.
Slovenian: Absolutna biološka uporabnost (AUC) deferasiroksa (v obliki disperzibilnih tablet) je okrog 70 % v primerjavi z intravenskim odmerkom.
English: Your doctor may require you to undergo a kidney biopsy, if he/she suspects significant kidney damage.
Slovenian: Zdravnik vas bo morda napotil na biopsijo ledvic, če bo posumil, da imate pomembno okvaro ledvic.
English: If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom), as Deferasirox Mylan may reduce the effectiveness of oral and patch contraceptives.
Slovenian: Če trenutno za zaščito pred nosečnostjo uporabljate peroralne kontraceptive (kontracepcijske tablete) ali kontracepcijski obliž, morate uporabljati še dodatno zaščito ali drugo vrsto kontracepcije (na primer kondom), saj zdravilo Deferasiroks Mylan lahko zmanjša učinkovitost kontracepcijskih tablet in obližev.
English: At these same doses, the ratios of iron excretion: iron intake were 1.02 (indicating net iron balance) and 1.67 (indicating net iron removal), respectively.
Slovenian: Pri enakih odmerkih je bilo razmerje med izločanjem in privzemom železa 1,02 (kar kaže na neto ravnovesje železa) oziroma 1,67 (kar kaže na neto odstranjevanje železa).
English: Deferasirox is an orally active chelator that is highly selective for iron(III).
Slovenian: Deferasiroks je peroralno aktiven kelator, ki je visoko selektiven za trovalentno železo (III).
English: Elderly patients The pharmacokinetics of deferasirox have not been studied in elderly patients (aged 65 or older).
Slovenian: Starejši bolniki Farmakokinetika deferasiroksa pri starejših bolnikih (starih 65 let ali več) ni bila proučena.
English: • Take Deferasirox Mylan film-coated tablets either on an empty stomach or with a light meal.
Slovenian: • Filmsko obložene tablete Deferasiroks Mylan vzemite bodisi na prazen želodec ali z lahkim obrokom.
English: Dose adjustments may be made in steps of 3.5 to 7 mg/kg and are to be tailored to the individual patient's response and therapeutic goals (maintenance or reduction of iron burden).
Slovenian: Prilagajanje odmerka lahko poteka v korakih po 3,5 do 7 mg/kg, prirediti jih je potrebno odzivu in ciljem zdravljenja posameznega bolnika (vzdrževanje ali zmanjševanje obremenitve z železom).
English: It is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload).
Slovenian: Je kelator železa - to je zdravilo, ki ga uporabljamo za odstranjevanje presežka železa iz telesa ('presežek železa' imenujemo tudi preobremenitev z železom).
English: One of the secondary efficacy parameters was the change in serum ferritin between baseline and fourth quarter.
Slovenian: Eden izmed sekundarnih parametrov učinkovitosti je bila sprememba vrednosti feritina v serumu med izhodiščno vrednostjo in zadnjo četrtino študije.
English: Additional tests may be required to monitor the blood levels of some of these medicines.
Slovenian: Za spremljanje koncentracije nekaterih od navedenih zdravil v krvi boste morda morali opraviti dodatne preiskave.
English: The Guide for healthcare professionals shall contain the following key elements:
Slovenian: Vodnik za zdravstvene delavce mora vsebovati naslednje ključne vsebine:
English: The results of the tests for serum creatinine, serum ferritin and serum transaminases should be recorded and regularly assessed for trends.
Slovenian: Izvide meritev vrednosti kreatinina, feritina in transaminaz v serumu je treba beležiti in redno ocenjevati njihove trende.
English: Gallstones and related biliary disorders were reported in about 2% of patients.
Slovenian: O žolčnih kamnih in z njimi povezanimi boleznimi žolčnika in žolčevodov so poročali pri približno 2 % bolnikov.
English: If you are switching from the dispersible tablets to these film-coated tablets, you will need an adjustment of the dose.
Slovenian: Če prehajate z uporabe disperzibilnih tablet na uporabo filmsko obloženih tablet, vam bo treba prilagoditi odmerek zdravila.
English: If you take more Deferasirox Mylan than you should If you have taken too much Deferasirox Mylan, or if someone else accidentally takes your tablets, contact your doctor or hospital for advice straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Deferasiroks Mylan, kot bi smeli Če ste vzeli preveč zdravila Deferasiroks Mylan ali je vaše tablete pomotoma zaužil kdo drug, takoj pokličite zdravnika ali v bolnišnico.
English: CYP450-catalysed (oxidative) metabolism of deferasirox appears to be minor in humans (about 8%).
Slovenian: Kaže, da poteka s CYP450 kataliziran (oksidativni) metabolizem deferasiroksa pri ljudeh le v majhnem obsegu (približno 8 %).
English: Elevations of transaminases greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon (0.3%).
Slovenian: Zvišanja vrednosti transaminaz, ki so bila večja od 10-kratne zgornje meje normalne vrednosti in so kazala na hepatitis, so bila občasna (0,3 %).
English: About two-thirds of the patients showing serum creatinine increase returned below the 33% level without dose adjustment.
Slovenian: Približno pri dveh tretjinah bolnikov z zvišanjem koncentracije kreatinina v serumu se je ta vrnila pod raven 33 % zvišanja brez prilagajanja odmerka.
English: Your eyesight and hearing will be tested each year during treatment as a precautionary measure.
Slovenian: Med zdravljenjem boste vsako leto kot previdnostni ukrep opravili testiranje vida in sluha.
English: In some cases, only a stabilisation of the serum creatinine values has been observed after dose reduction.
Slovenian: V nekaterih primerih so po znižanju odmerka opažali samo stabilizacijo vrednosti kreatinina v serumu.
English: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Slovenian: McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska
English: Deferasirox was not teratogenic, but caused increased frequency of skeletal variations and stillborn pups in rats at high doses that were severely toxic to the non-iron-overloaded mother.
Slovenian: Deferasiroks ni bil teratogen, je pa povzročil povečano pogostnost skeletnih sprememb in mrtvorojenih mladičev pri podganah v visokih odmerkih, ki so bili zelo toksični za matere, ki niso bile preobremenjene z železom.
English: If there is a persistent and progressive increase in serum transaminase levels that cannot be attributed to other causes, deferasirox should be interrupted.
Slovenian: V primeru persistentnega in progresivnega zvišanja koncentracij transaminaz v serumu, ki ga ni mogoče pripisati drugim vzrokom, je treba zdravljenje z zdravilom Deferasiroks Mylan prekiniti.
English: After a high-fat meal, AUC and Cmax were increased (by 18% and 29%, respectively).
Slovenian: Po zaužitju obroka z visoko vsebnostjo maščob sta bili vrednosti AUC in Cmax višji (za 18 % oziroma 29 %).
English: ◦ The need to consider renal biopsy:
Slovenian: o potreba po razmisleku glede ledvične biopsije:
English: Since the interaction has not been established with dosages higher than 0.5 mg for repaglinide, the concomitant use of deferasirox with repaglinide should be avoided.
Slovenian: Ker medsebojnega delovanja pri odmerkih repaglinida nad 0,5 mg niso ugotovili, se je treba sočasni uporabi deferasiroksa in repaglinida izogibati.
English: However, the role of deferasirox as a contributing or aggravating factor cannot be excluded (see section 4.8).
Slovenian: Vendar pa ni mogoče izključiti, da bi imel pri tem deferasiroks lahko vlogo dejavnika, ki dodatno prispeva k takemu stanju ali ga poslabša (glejte poglavje 4.8).
English: The Cmax and AUC0-24h of deferasirox increase approximately linearly with dose under steady-state conditions.
Slovenian: Cmax in AUC0-24h deferasiroksa naraščata približno linearno z odmerkom v pogojih dinamičnega ravnovesja.
English: At a starting dose of 10 mg/kg/day, deferasirox dispersible tablets led to reductions in indicators of total body iron.
Slovenian: Pri začetnem odmerku 10 mg/kg/dan je deferasiroks v obliki disperzibilnih tablet povzročil znižanje vrednosti kazalcev celotnega železa v telesu.
English: In addition, before treating heavily iron-overloaded children with non-transfusion-dependent thalassaemia with Deferasirox Mylan, the physician should be aware that the consequences of long-term exposure in such patients are currently not known.
Slovenian: Poleg tega se mora zdravnik pred začetkom zdravljenja otrok s težko preobremenitvijo z železom z zdravilom Deferasiroks Mylan zavedati, da posledice pri dolgotrajnem zdravljenju teh bolnikov trenutno niso znane.
English: Patients experiencing the uncommon adverse reaction of dizziness should exercise caution when driving or operating machines (see section 4.8).
Slovenian: Bolniki, pri katerih pride do redkega neželenega učinka omotičnosti, morajo biti pri vožnji in upravljanju s stroji previdni (glejte poglavje 4.8).
English: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Slovenian: reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)
English: Your doctor will take these tests into consideration when deciding on the dose of Deferasirox Mylan most suitable for you and will also use these tests to decide when you should stop taking Deferasirox Mylan.
Slovenian: Te preiskave bo vaš zdravnik upošteval pri izbiranju za vas najbolj ustreznega odmerka zdravila Deferasiroks Mylan in se na podlagi izvidov teh preiskav tudi odločil, kdaj bi morali prenehati z jemanjem zdravila Deferasiroks Mylan.
English: For substances that are predominantly metabolised by CYP1A2 and that have a narrow therapeutic index (e.g. clozapine, tizanidine), the same recommendations apply as for theophylline.
Slovenian: Za zdravilne učinkovine, ki se pretežno presnavljajo s CYP1A2 in imajo ozek terapevtski indeks, (na primer klozapin in tizanidin) veljajo enaka priporočila kot za teofilin.
English: The dose should be immediately and completely consumed, and not stored for future use.
Slovenian: Bolnik naj odmerek zaužije takoj in v celoti, tako pripravljenega odmerka se ne sme shranjevati za kasnejšo uporabo.
English: The MAH shall ensure that, at launch, in each Member State where Deferasirox Mylan is marketed, all healthcare professionals and patients who are expected to prescribe, dispense and use Deferasirox Mylan are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, v katerih bo zdravilo Deferasiroks Mylan na trgu, ob prihodu zdravila na trg vsi zdravstveni delavci in bolniki, za katere se pričakuje, da bodo predpisovali, izdajali ali uporabljali zdravilo Deferasiroks Mylan, prejeli naslednji paket izobraževalnih gradiv: