natgillin/translations-raw huggingface dataset:
Do not take Deferasirox Mylan - if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila Deferasiroks Mylan - če ste alergični na deferasiroks ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
You may also have MRI (magnetic resonance imaging) tests to determine the amount of iron in your liver. 
Poleg tega boste morda opravili preiskavo z MR (magnetno resonančnim) slikanjem, s katero je mogoče določiti količino železa v vaših jetrih.
Deferasirox was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/− heterozygous mice in a 6-month study. 
Deferasiroks ni bil karcinogen, ko so ga uporabili pri podganah v 2-letni študiji in transgenskih p53+/- heterozigotnih miših v 6-mesečni študiji.
Manufacturer Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom 
Izdelovalec Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, Velika Britanija
If you have questions about how long to take Deferasirox Mylan, talk to your doctor. 
Če imate vprašanja o tem, kako dolgo jemati zdravilo Deferasiroks Mylan, se pogovorite s svojim zdravnikom.
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. 
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.
The safety of deferasirox in combination with other iron chelators has not been established. 
Varnost uporabe deferasiroksa v kombinaciji z drugimi kelatorji železa ni bila ugotovljena.
An erroneously administered single dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment. 
Pomotoma apliciran enkratni odmerek 90 mg/kg je povzročil Fanconijev sindrom, ki pa je po zdravljenju izzvenel.
Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3. 
Glukuronidacija deferasiroksa poteka predvsem z UGT1A1, manj pa z UGT1A3.
Contraindicated 
kontraindicirano
If deferasirox and theophylline are used concomitantly, monitoring of theophylline concentration and theophylline dose reduction should be considered. 
Če se deferasiroks in teofilin uporabljata sočasno, je treba razmisliti o spremljanju koncentracije teofilina in znižanju odmerka teofilina.
If any of these apply to you, tell your doctor straight away. 
Če karkoli od navedenega velja za vas, takoj obvestite svojega zdravnika.
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. 
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.
In some post-marketing cases, renal function deterioration has led to renal failure requiring temporary or permanent dialysis. 
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.
• Tear in stomach or intestine wall that can be painful and cause nausea 
• raztrganje stene želodca ali črevesa, ki je lahko zelo boleče in povzroči občutek slabosti
The rashes resolve spontaneously in most cases. 
Izpuščaji večinoma spontano izzvenijo.
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). 
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).
Combination with other iron chelator therapies as the safety of such combinations has not been established (see section 4.5). 
Kombinacija zdravljenja z drugimi kelatorji železa, saj varnost takih kombinacij ni bila ugotovljena (glejte poglavje 4.5).
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). 
Preiskave bodo pokazale tudi delovanje vaših ledvic (vrednost kreatinina v krvi, prisotnost proteinov v urinu) in jeter (vrednosti transaminaz v krvi).
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. 
• 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.
• Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose. 
• Glede na vaš odziv na zdravljenje vam bo zdravnik kasneje prilagodil zdravljenje in vam morda zvišal ali znižal odmerek.
The kidney toxicity is considered mainly due to iron deprivation in animals that were not previously overloaded with iron. 
Menijo, da je do toksičnosti za ledvice prišlo predvsem zaradi pomanjkanja železa pri živalih, ki predhodno niso bile preobremenjene z železom.
These reactions are dosedependent, mostly mild to moderate, generally transient and mostly resolve even if treatment is continued. 
Ti učinki so odvisni od odmerka, večinoma so blagi do zmerni, v glavnem prehodnega značaja in večinoma izzvenijo tudi ob nadaljevanju zdravljenja.
Doses above 28 mg/kg are not recommended because there is only limited experience with doses above this level (see section 5.1). 
Odmerki nad 28 mg/kg niso priporočljivi, saj so na voljo le omejene izkušnje z odmerki nad to vrednostjo (glejte poglavje 5.1).
Fifty-six patients under the age of 6 years participated in this pivotal study, 28 of them receiving deferasirox dispersible tablets. 
V to ključno študijo je bilo vključenih 56 bolnikov mlajših od 6 let, od teh jih je 28 prejemalo deferasiroks v obliki disperzibilnih tablet.
Deferasirox metabolism depends on UGT enzymes. 
Presnova deferasiroksa je odvisna od encimov UGT.
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. 
Namen terapije s kelacijo železa je odstraniti količino železa, ki je bila vnešena s transfuzijo, in po potrebi zmanjšati obstoječo obremenitev z železom.
Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment. 
Večinoma so ti neželeni učinki blagi do zmerni in izzvenijo v nekaj dneh do nekaj tednih zdravljenja.
These side effects are uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people). 
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).
Standard procedures for management of overdose may be indicated as well as symptomatic treatment, as medically appropriate. 
Za zdravljenje v primeru prevelikega odmerjanja so lahko indicirani običajni ukrepi, pa tudi simptomatsko zdravljenje, če je medicinsko upravičeno.
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. 
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.
The absolute bioavailability (AUC) of deferasirox (dispersible tablet formulation) is about 70% compared to an intravenous dose. 
Absolutna biološka uporabnost (AUC) deferasiroksa (v obliki disperzibilnih tablet) je okrog 70 % v primerjavi z intravenskim odmerkom.
Your doctor may require you to undergo a kidney biopsy, if he/she suspects significant kidney damage. 
Zdravnik vas bo morda napotil na biopsijo ledvic, če bo posumil, da imate pomembno okvaro ledvic.
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. 
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.
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. 
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).
Deferasirox is an orally active chelator that is highly selective for iron(III). 
Deferasiroks je peroralno aktiven kelator, ki je visoko selektiven za trovalentno železo (III).
Elderly patients The pharmacokinetics of deferasirox have not been studied in elderly patients (aged 65 or older). 
Starejši bolniki Farmakokinetika deferasiroksa pri starejših bolnikih (starih 65 let ali več) ni bila proučena.
• Take Deferasirox Mylan film-coated tablets either on an empty stomach or with a light meal. 
• Filmsko obložene tablete Deferasiroks Mylan vzemite bodisi na prazen želodec ali z lahkim obrokom.
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). 
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).
It is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload). 
Je kelator železa - to je zdravilo, ki ga uporabljamo za odstranjevanje presežka železa iz telesa ('presežek železa' imenujemo tudi preobremenitev z železom).
One of the secondary efficacy parameters was the change in serum ferritin between baseline and fourth quarter. 
Eden izmed sekundarnih parametrov učinkovitosti je bila sprememba vrednosti feritina v serumu med izhodiščno vrednostjo in zadnjo četrtino študije.
Additional tests may be required to monitor the blood levels of some of these medicines. 
Za spremljanje koncentracije nekaterih od navedenih zdravil v krvi boste morda morali opraviti dodatne preiskave.
The Guide for healthcare professionals shall contain the following key elements: 
Vodnik za zdravstvene delavce mora vsebovati naslednje ključne vsebine:
The results of the tests for serum creatinine, serum ferritin and serum transaminases should be recorded and regularly assessed for trends. 
Izvide meritev vrednosti kreatinina, feritina in transaminaz v serumu je treba beležiti in redno ocenjevati njihove trende.
Gallstones and related biliary disorders were reported in about 2% of patients. 
O žolčnih kamnih in z njimi povezanimi boleznimi žolčnika in žolčevodov so poročali pri približno 2 % bolnikov.
If you are switching from the dispersible tablets to these film-coated tablets, you will need an adjustment of the dose. 
Če prehajate z uporabe disperzibilnih tablet na uporabo filmsko obloženih tablet, vam bo treba prilagoditi odmerek zdravila.
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. 
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.
CYP450-catalysed (oxidative) metabolism of deferasirox appears to be minor in humans (about 8%). 
Kaže, da poteka s CYP450 kataliziran (oksidativni) metabolizem deferasiroksa pri ljudeh le v majhnem obsegu (približno 8 %).
Elevations of transaminases greater than 10 times the upper limit of the normal range, suggestive of hepatitis, were uncommon (0.3%). 
Zvišanja vrednosti transaminaz, ki so bila večja od 10-kratne zgornje meje normalne vrednosti in so kazala na hepatitis, so bila občasna (0,3 %).
About two-thirds of the patients showing serum creatinine increase returned below the 33% level without dose adjustment. 
Približno pri dveh tretjinah bolnikov z zvišanjem koncentracije kreatinina v serumu se je ta vrnila pod raven 33 % zvišanja brez prilagajanja odmerka.
Your eyesight and hearing will be tested each year during treatment as a precautionary measure. 
Med zdravljenjem boste vsako leto kot previdnostni ukrep opravili testiranje vida in sluha.
In some cases, only a stabilisation of the serum creatinine values has been observed after dose reduction. 
V nekaterih primerih so po znižanju odmerka opažali samo stabilizacijo vrednosti kreatinina v serumu.
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. 
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.
If there is a persistent and progressive increase in serum transaminase levels that cannot be attributed to other causes, deferasirox should be interrupted. 
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.
After a high-fat meal, AUC and Cmax were increased (by 18% and 29%, respectively). 
Po zaužitju obroka z visoko vsebnostjo maščob sta bili vrednosti AUC in Cmax višji (za 18 % oziroma 29 %).
◦ The need to consider renal biopsy: 
o potreba po razmisleku glede ledvične biopsije:
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. 
Ker medsebojnega delovanja pri odmerkih repaglinida nad 0,5 mg niso ugotovili, se je treba sočasni uporabi deferasiroksa in repaglinida izogibati.
However, the role of deferasirox as a contributing or aggravating factor cannot be excluded (see section 4.8). 
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).
The Cmax and AUC0-24h of deferasirox increase approximately linearly with dose under steady-state conditions. 
Cmax in AUC0-24h deferasiroksa naraščata približno linearno z odmerkom v pogojih dinamičnega ravnovesja.
At a starting dose of 10 mg/kg/day, deferasirox dispersible tablets led to reductions in indicators of total body iron. 
Pri začetnem odmerku 10 mg/kg/dan je deferasiroks v obliki disperzibilnih tablet povzročil znižanje vrednosti kazalcev celotnega železa v telesu.
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. 
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.
Patients experiencing the uncommon adverse reaction of dizziness should exercise caution when driving or operating machines (see section 4.8). 
Bolniki, pri katerih pride do redkega neželenega učinka omotičnosti, morajo biti pri vožnji in upravljanju s stroji previdni (glejte poglavje 4.8).
Drug reaction with eosinophilia and systemic symptoms (DRESS) 
reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)
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. 
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.
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. 
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.
The dose should be immediately and completely consumed, and not stored for future use. 
Bolnik naj odmerek zaužije takoj in v celoti, tako pripravljenega odmerka se ne sme shranjevati za kasnejšo uporabo.
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: 
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:
Deferasirox Mylan can be used in children and adolescents receiving regular blood transfusions aged 2 years and over and in children and adolescents not receiving regular blood transfusions aged 10 years and over. 
Zdravilo Deferasiroks Mylan se lahko uporablja pri otrocih in mladostnikih, ki prejemajo redne transfuzije krvi, starih 2 leti ali več, in pri otrocih in mladostnikih, ki ne prejemajo rednih transfuzij krvi, starih 10 let ali več.
As a consequence, Deferasirox Mylan therapy should be closely monitored to detect adverse reactions and to follow iron burden in the paediatric population. 
Posledično je treba zdravljenje z zdravilom Deferasiroks Mylan skrbno spremljati z namenom odkrivanja neželenih učinkov in slediti obremenitvi z železom pri pediatrični populaciji.
The concomitant administration of deferasirox with anticoagulants may also increase the risk of gastrointestinal haemorrhage. 
Sočasna uporaba deferasiroksa z antikoagulanti lahko tudi poveča tveganje za gastrointestinalne krvavitve.
In the remaining third the serum creatinine increase did not always respond to a dose reduction or a dose interruption. 
Pri preostali tretjini bolnikov se zvišanje koncentracije kreatinina v serumu ni vedno odzvalo na zniževanje odmerka ali prekinitev zdravljenja.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 
Neuporabljeno zdravilo ali odpadni material zavrzite v skaldu z lokalnimi predpisi.
When this results in a daily dose less than 14 mg/kg body weight, the patient's response must be monitored and a dose increase should be considered if sufficient efficacy is not obtained (see section 5.1). 
Če to pomeni dnevni odmerek, ki bi bil nižji od 14 mg/kg telesne mase, je treba spremljati bolnikov odziv in v primerih, ko ne pride do zadostne učinkovitosti, razmisliti o zvišanju odmerka (glejte poglavje 5.1).
• A warning on the risk of overchelation and on the necessity of close monitoring of serum ferritin levels and renal and hepatic function. 
• opozorilo glede tveganja za prekomerno kelacijo in potrebo po skrbnem spremljanju vrednosti feritina v serumu ter ledvične in jetrne funkcije;
It is recommended that serum transaminases, bilirubin and alkaline phosphatase be checked before the initiation of treatment, every 2 weeks during the first month and monthly thereafter. 
Transaminaze v serumu, bilirubin in alkalno fosfatazo je priporočljivo pregledovati pred začetkom zdravljenja, nato pa v prvem mesecu vsaka 2 tedna, kasneje pa enkrat mesečno.
Patients should be referred to a renal specialist, and further specialised investigations (such as renal biopsy) may be considered if the following occur despite dose reduction and interruption: 
Bolnika je treba napotiti k nefrologu in pretehtati možnost nadaljnjih specialističnih preiskav (kot je ledvična biopsija), če kljub znižanju odmerka in prekinitvi zdravljenja pride do naslednjega:
Treatment cessation 
Prekinitev zdravljenja
Pharmacotherapeutic group: Iron chelating agents, ATC code: V03AC03 
Farmakoterapevtska skupina: kelirajoča sredstva za zdravljenje akutnih zastrupitev z železom, oznaka ATC: V03AC03
Table 4 Summary of safety monitoring recommendations 
Preglednica 4 Povzetek varnostnih priporočil za spremljanje bolnika Preiskava
Although deferasirox has a lower affinity for aluminium than for iron, it is not recommended to take deferasirox tablets with aluminium-containing antacid preparations. 
Čeprav ima deferasiroks manjšo afiniteto do aluminija kot do železa, ni priporočljivo jemati tablet z deferasiroksom sočasno z antacidi, ki vsebujejo aluminij.
Multiple ulcers have been observed in some patients (see section 4.8). 
Pri nekaterih bolnikih so opažali številne ulkuse (glejte poglavje 4.8).
Deferasirox has been investigated in 411 adult (age ≥16 years) and 292 paediatric patients (aged 2 to <16 years) with chronic iron overload due to blood transfusions. 
Deferasiroks so raziskovali pri 411 odraslih (starih 16 let ali več) in 292 pediatričnih bolnikih (starih od 2 do 16 let) s kronično preobremenitvijo z železom zaradi transfuzij krvi.
Therefore, it must not be combined with other iron chelator therapies (see section 4.3). 
Zato se ga ne sme uporabljati v kombinaciji z drugimi kelatorji železa (glejte poglavje 4.3).
• If you experience frequent abdominal pain, particularly after eating or taking Deferasirox 
• če vas pogosto boli trebuh, posebno po uživanju hrane ali po jemanju zdravila Deferasiroks
No fertility data is available for humans. 
Podatkov o vplivu na plodnost pri človeku ni na voljo.
The patient's response must be monitored and a dose increase should be considered if sufficient efficacy is not obtained (see section 5.1). 
Bolnikov odziv je treba spremljati in v primerih, ko ne pride do zadostne učinkovitosti, razmisliti o zvišanju odmerka (glejte poglavje 5.1).
Auditory and ophthalmic testing (including fundoscopy) is recommended before the start of treatment and at regular intervals thereafter (every 12 months). 
Testiranje sluha in vida (vključno s fundoskopijo) je priporočljivo pred začetkom zdravljenja in nato v rednih intervalih (vsakih 12 mesecev).
The principal analysis of the pivotal comparative study in 586 patients suffering from betathalassaemia and transfusional iron overload did not demonstrate non-inferiority of deferasirox dispersible tablets to deferoxamine in the analysis of the total patient population. 
Osnovna analiza podatkov ključne primerjalne študije s 586 bolniki z beta talasemijo in s preobremenitvijo z železom zaradi transfuzij ni dokazala neinferiornosti deferasiroksa v obliki disperzibilnih tablet v primerjavi z deferoksaminom v analizi celotne populacije bolnikov.
In severe cases, this reintroduction could be conducted in combination with a short period of oral steroid administration. 
V hudih primerih je mogoče ponovno uvesti zdravljenje v kombinaciji s kratkotrajno uporabo peroralnih steroidov.