FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no or limited amount of data from the use of nilotinib in pregnant women.
Slovenian: Podatkov o uporabi nilotiniba pri nosečnicah ni oziroma so omejeni.
English: Resistance to imatinib included failure to achieve a complete haematological response (by 3 months), cytogenetic response (by 6 months) or major cytogenetic response (by 12 months) or progression of disease after a previous cytogenetic or haematological response.
Slovenian: Rezistenca na imatinib je pomenila, da ni prišlo do popolnega hematološkega odziva (v 3 mesecih), do citogenetičnega odziva (v 6 mesecih) ali do pomembnega citogenetičnega odziva (v 12 mesecih), ali da je prišlo do napredovanja bolezni po predhodnem citogenetičnem ali hematološkem odzivu.
English: During treatment with Tasigna - if you faint (loss of consciousness) or have an irregular heart beat while taking this medicine, tell your doctor immediately as this may be a sign of a serious heart condition.
Slovenian: V času zdravljenja z zdravilom Tasigna - če v času jemanja tega zdravila kdaj omedlite (izgubite zavest) ali če pride do nepravilnega bitja srca, takoj povejte svojemu zdravniku, ker je to lahko znak resne bolezni srca.
English: The pharmacokinetic exposure of nilotinib following a single or multiple doses appeared to be comparable between paediatric patients from 2 years to <10 years and from ≥10 years to <18 years.
Slovenian: Pokazalo se je, da je farmakokinetična izpostavljenost nilotinibu po enkratnem oziroma večkratnem odmerjanju primerljiva med pediatričnimi bolniki, ki so stari od 2 leti do manj kot 10 let, in tistimi, ki so stari 10 let ali več do manj kot 18 let.
English: Grapefruit juice and other foods that are known to inhibit CYP3A4 should be avoided.
Slovenian: Izogibati se je treba uživanju grenivkinega soka in drugih živil, za katera je znano, da zavirajo CYP3A4.
English: It may increase the amount of Tasigna in the blood, possibly to a harmful level.
Slovenian: To bi vam lahko povečalo količino zdravila Tasigna v krvi, lahko tudi toliko, da postane škodljivo.
English: Complete haematological response (CHR) in CP patients was evaluated as a secondary endpoint.
Slovenian: Popolni hematološki odziv (CHR) so pri bolnikih v kronični fazi ocenjevali kot sekundarni cilj opazovanja.
English: No effects on sperm count/motility or on fertility were noted in male and female rats up to the highest tested dose, approximately 5 times the recommended dosage for humans.
Slovenian: Pri podganjih samcih in samicah niso opažali vpliva na število/gibljivost spermijev in na plodnost do najvišjega testiranega odmerka, ki je približno 5-kratnik priporočenega odmerka za ljudi.
English: The median time to achieve CCyR was just past 3 months (median 3.4 months).
Slovenian: Mediani čas do popolnega citogenetičnega odziva je bil nekaj več kot 3 mesece (mediano 3,4 mesece).
English: The cardiovascular status of patients should be evaluated and cardiovascular risk factors monitored and actively managed during nilotinib therapy according to standard guidelines.
Slovenian: Oceniti je treba bolnikov srčnožilni status in tekom zdravljenja z nilotinibom redno spremljati dejavnike srčnožilnega tveganja in jih obravnavati v skladu s standardnimi smernicami.
English: None of the metabolites contribute significantly to the pharmacological activity of nilotinib.
Slovenian: Noben od presnovkov ne prispeva pomembno k farmakološkemu delovanju nilotiniba.
English: Nilotinib did not induce teratogenicity, but did show embryo- and foetotoxicity at doses that also showed maternal toxicity.
Slovenian: Nilotinib ni povzročal teratogenosti, je pa izkazal toksičnost za zarodek in plod pri odmerkih, ki so bili toksični tudi za mater.
English: If you stop taking Tasigna
Slovenian: Če ste prenehali jemati zdravilo Tasigna
English: What Tasigna is and what it is used for What you need to know before you take Tasigna How to take Tasigna
Slovenian: Kaj je zdravilo Tasigna in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tasigna Kako jemati zdravilo Tasigna Možni neželeni učinki
English: Available toxicological data in animals have shown excretion of nilotinib in milk (see section 5.3).
Slovenian: Razpoložljivi toksikološki podatki pri živalih kažejo na izločanje nilotiniba v mleko (glejte poglavje 5.3).
English: Nilotinib has little or no effect against the majority of other protein kinases examined, including Src, except for the PDGF, KIT and Ephrin receptor kinases, which it inhibits at concentrations within the range achieved following oral administration at therapeutic doses recommended for the treatment of CML (see Table 6).
Slovenian: Nilotinib le malo oziroma sploh ne učinkuje proti večini drugih preizkušanih protein kinaz, vključno s Src, kar pa ne velja za PDGF, KIT in Ephrin receptor kinaze, ki jih zavira v okviru koncentracij, doseženih s peroralno aplikacijo priporočenih terapevtskih odmerkov za zdravljenje KML (glejte preglednico 6).
English: Clinical studies have not been performed in patients with impaired renal function.
Slovenian: Kliničnih študij pri bolnikih z okvarjenim delovanjem ledvic niso izvajali.
English: Exposures at the lowest dose levels at which the liver effects were seen were lower than the exposure in humans at a dose of 800 mg/day.
Slovenian: Izpostavljenosti pri najnižjih ravneh odmerkov, pri katerih so opazili vpliv na jetra, so bile nižje od izpostavljenosti pri ljudeh pri odmerku 800 mg/dan.
English: Laboratory abnormalities of mild to moderate transient elevations of aminotransferases and total bilirubin have been observed in children at a higher frequency than in adults, indicating a higher risk of hepatotoxicity in the paediatric population (see section 4.8).
Slovenian: Pri otrocih so opažali laboratorijske nepravilnosti z blagim do zmernim prehodnim zvišanjem koncentracij aminotransferaz in celotnega bilirubina pogosteje kot pri odraslih, kar kaže na večje tveganje za hepatotoksičnost pri pediatrični populaciji (glejte poglavje 4.8).
English: The median duration of exposure was 60.5 months (range 0.1-70.8 months).
Slovenian: Srednja vrednost trajanja izpostavljenosti je bila 60,5 meseca (od 0,1 do 70,8 meseca).
English: How much Tasigna to take
Slovenian: Koliko zdravila Tasigna je treba jemati
English: - the electrolytes in the body (potassium, magnesium).
Slovenian: - vrednosti elektrolitov (kalija in magnezija) v telesu.
English: Posology for Philadelphia chromosome positive CML paediatric patients Dosing in paediatric patients is individualised and is based on body surface area (mg/m2).
Slovenian: Odmerjanje za pediatrične bolnike s KML s prisotnim kromosomom Philadelphia Pri pediatričnih bolnikih je odmerjanje individualno in temelji na telesni površini (mg/m2).
English: The rates of response for the two treatment arms are reported in Table 12.
Slovenian: Deleži odzivov v obeh terapevtskih krakih so navedeni v preglednici 12.
English: There is no experience with treatment of paediatric patients below 2 years of age.
Slovenian: Z zdravljenjem pediatričnih bolnikov, ki so stari manj kot 2 leti, ni nobenih izkušenj.
English: Forty-eight of these 51 patients (94.1%) regained MR4.0 and 47 patients (92.2%) regained MR4.5 by the time of the cut-off date.
Slovenian: Oseminštirideset od teh 51 bolnikov (94,1 %) je ponovno doseglo odziv MR 4.0, 47 bolnikov (92,2 %) pa je ponovno doseglo odziv MR 4.5 do presečnega datuma.
English: Treatment with nilotinib must be interrupted and blood count monitored.
Slovenian: Zdravljenje z nilotinibom je treba prekiniti in spremljati krvno sliko.
English: If you have taken more Tasigna than you should have, or if someone else accidentally takes your hard capsules, contact a doctor or hospital for advice straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Tasigna, kot bi smeli Če ste vzeli več zdravila Tasigna, kot bi smeli, ali če je nekdo drug pomotoma zaužil vaše trde kapsule, se nemudoma posvetujte z zdravnikom oziroma pokličite v bolnišnico.
English: Peak concentrations of nilotinib are reached 3 hours after oral administration.
Slovenian: Do najvišjih koncentracij nilotiniba pride 3 ure po zaužitju.
English: These tests will monitor: - the amount of blood cells (white blood cells, red blood cells and platelets) in the body to see how Tasigna is tolerated.
Slovenian: Preiskave bodo pokazale: - število krvnih celic (levkocitov, eritrocitov in trombocitov) v telesu, da boste vedeli, kako prenašate zdravilo Tasigna.
English: If a woman who is being treated with nilotinib is considering pregnancy, treatment discontinuation may be considered based on the eligibility criteria for discontinuing treatment as described in sections 4.2 and 4.4.
Slovenian: Če ženska, ki se zdravi z nilotinibom, želi zanositi, je treba razmisliti o prekinitvi zdravljenja na osnovi kriterijev primernosti za prekinitev zdravljenja, ki so navedeni v poglavjih 4.2 in 4.4.
English: Clinically relevant or severe abnormalities of routine haematological or biochemistry laboratory values in adult patients are presented in Table 5.
Slovenian: V preglednici 5 so prikazane klinično pomembne ali hude nepravilnosti rutinskih hematoloških ali biokemijskih laboratorijskih izvidov pri odraslih bolnikih.
English: Eighty-five of these 86 patients (98.8%) regained MMR, (one patient discontinued study permanently due to subject decision) and 76 patients (88.4%) regained MR4.5 by the time of the cut-off date.
Slovenian: Petinosemdeset od teh 86 bolnikov (98,8 %) je ponovno doseglo odziv MMR, (en bolnik je dokončno prekinil sodelovanje v študiji po svoji odločitvi) in 76 bolnikov (88,4 %) je ponovno doseglo odziv MR 4.5 do presečnega datuma.
English: In healthy subjects receiving esomeprazole at 40 mg once daily for 5 days, gastric pH was markedly increased, but nilotinib absorption was only decreased modestly (27% decrease in Cmax and 34% decrease in AUC0-∞).
Slovenian: Pri zdravih osebah, ki so 5 dni prejemale esomeprazol v odmerku 40 mg enkrat na dan, se je pH vrednost v želodcu izrazito zvišala, pri tem pa se je absorpcija nilotiniba le zmerno zmanjšala (Cmax se je znižala za 27 %, AUC-∞ pa se je zmanjšala za 34 %).
English: The absorption and bioavailability of nilotinib are increased if it is taken with food, resulting in a higher serum concentration (see sections 4.2, 4.4 and 5.2).
Slovenian: Pri zaužitju nilotiniba skupaj s hrano se njegovi absorpcija in biološka uporabnost povečata, kar povzroči višjo koncentracijo v serumu (glejte poglavja 4.2, 4.4 in 5.2).
English: Table 3 Non-haematological adverse reactions (≥5% of all patients)*
Slovenian: Preglednica 3 Nehematološki neželeni učinki (pri več kot 5 % vseh bolnikov)*
English: Treatment must be resumed within 2 weeks at prior dose if ANC >1.5 x 10
Slovenian: Z zdravljenjem je treba ponovno začeti v 2 tednih s predhodnim odmerkom, če je ANC >1,5 x 10
English: BCR-ABL transcript levels must be assessed prior to and during treatment discontinuation (see sections 4.2 and 5.1).
Slovenian: Raven prepisov BCR-ABL je treba meriti pred prekinitvijo zdravljenja in v času prekinitve (glejte poglavji 4.2 in 5.1).
English: The primary endpoint in the AP patients was overall confirmed haematological response (HR), defined as either a complete haematological response, no evidence of leukaemia or return to chronic phase.
Slovenian: Primarni cilj opazovanj pri bolnikih v pospešeni fazi so bili vsi ugotovljeni hematološki odzivi skupaj (HR), kar je bilo opredeljeno kot bodisi popolni hematološki odziv, odsotnost znakov levkemije ali vrnitev v kronično fazo.
English: The safety and efficacy of Tasigna in paediatric patients with Philadelphia chromosome positive CML in chronic phase from 2 to less than 18 years of age have been established (see sections 4.8, 5.1 and 5.2).
Slovenian: Varnost in učinkovitost zdravila Tasigna pri pediatričnih bolnikih, ki imajo KML s prisotnim kromosomom Philadelphia v kronični fazi in so stari od 2 leti do manj kot 18 let, sta dokazani (glejte poglavja 4.8, 5.1 in 5.2).
English: Among the 53 patients who discontinued the TFR phase due to confirmed loss of MR4.0 or loss of MMR, 51 patients restarted nilotinib and 2 patients discontinued the study.
Slovenian: Med 53 bolniki, ki so prekinili fazo remisije brez zdravljenja zaradi potrjene izgube odziva MR 4.0 ali izgube glavnega molekularnega odgovora, je 51 bolnikov ponovno začelo prejemati nilotinib, 2 bolnika pa sta prekinila sodelovanje v študiji.
English: Nilotinib is a potent inhibitor of the ABL tyrosine kinase activity of the BCR-ABL oncoprotein both in cell lines and in primary Philadelphia-chromosome positive leukaemia cells.
Slovenian: Nilotinib je močan zaviralec delovanja ABL tirozin-kinaze BCR-ABL onkoproteina tako v celičnih linijah kot tudi v primarnih levkemičnih celicah s prisotnim kromosomom Philadelphia.
English: Treatment must be resumed within 2 weeks at prior dose if ANC >1.0 x 10
Slovenian: Z zdravljenjem je treba ponovno začeti v 2 tednih s predhodnim odmerkom, če je ANC >1,0 x 10
English: No patient had a LVEF of <45% during treatment nor an absolute reduction in LVEF of more than
Slovenian: V času zdravljenja ni bil pri nobenem od bolnikov iztisni delež levega prekata manjši od 45 %, pa tudi do absolutnega zmanjšanja iztisnega deleža levega prekata za več kot 15 % ni prišlo.
English: Animal studies did not show an effect on fertility in male and female rats (see section 5.3).
Slovenian: Študije na živalih niso pokazale vpliva na plodnost pri podganjih samcih in samicah (glejte poglavje 5.3).
English: For Grade 2 bilirubin elevations or Grade 3 hepatic transaminase elevations in paediatric patients, treatment must be interrupted until the levels return to Grade 1.
Slovenian: Pri zvišanju koncentracije bilirubina stopnje 2 ali zvišanju koncentracij jetrnih aminotransferaz stopnje 3 pri pediatričnih bolnikih je treba zdravljenje prekiniti, dokler se vrednosti ne znižajo do stopnje 1.
English: In a pre- and postnatal development study in rats, maternal exposure to nilotinib caused reduced pup body weight with associated changes in physical development parameters as well as reduced mating and fertility indices in the offspring.
Slovenian: V študijah antenatalnega in postnatalnega razvoja pri podganah je izpostavljenost samic zdravilu povzročila znižano telesno maso mladičev in s tem povezane spremembe parametrov telesnega razvoja ter zmanjšanje kazalcev parjenja in plodnosti pri potomcih.
English: Events included neutropenia, vomiting and drowsiness.
Slovenian: V teh primerih je med drugim prišlo do nevtropenije, bruhanja in zaspanosti.
English: The primary endpoint was the proportion of patients without confirmed loss of MR4.0 or loss of MMR within 48 weeks following treatment discontinuation.
Slovenian: Primarni cilj študije je bil delež bolnikov brez potrjene izgube odziva MR 4.0 ali izgube glavnega molekularnega odgovora v 48 tednih po prekinitvi zdravljenja.
English: The highest prior imatinib dose was 600 mg/day in 74% of all patients, with 40% of patients receiving imatinib doses 800 mg/day.
Slovenian: Najvišji predhodni odmerek imatiniba je bil pri 74 % vseh bolnikov enak ali večji od 600 mg/dan, 40 % bolnikov pa je prejemalo odmerke imatiniba, ki so bili enaki ali večji od 800 mg/dan.
English: If you forget to take Tasigna
Slovenian: Če ste pozabili vzeti zdravilo Tasigna
English: MCyR rate was 30% with a median time to response of 2.8 months.
Slovenian: Delež pomembnih citogenetičnih odzivov je bil 30 % z mediano časa do odziva 2,8 meseca.
English: Biochemical adverse drug reactions include alanine aminotransferase increased (24%), hyperbilirubinaemia (16%), aspartate aminotransferase increased (12%), lipase increased (11%), blood bilirubin increased (10%), hyperglycaemia (4%), hypercholesterolaemia (3%) and hypertriglyceridaemia (<1%).
Slovenian: Neželeni učinki na biokemijske parametre so vključevali zvišanje vrednosti alanin-aminotransferaze (24 %), hiperbilirubinemijo (16 %), zvišanje vrednosti aspartat-aminotransferaze (12 %), zvišanje vrednosti lipaze (11 %), zvišanje koncentracije bilirubina v krvi (10 %), hiperglikemijo (4 %), hiperholesterolemijo (3 %) in hipertrigliceridemijo (< 1 %).
English: After a single dose of radiolabelled nilotinib in healthy subjects, more than 90% of the dose was eliminated within 7 days, mainly in faeces (94% of the dose).
Slovenian: Pri zdravih osebah se je po enkratnem odmerku več kot 90 % odmerka radioaktivno označenega nilotiniba izločilo v 7 dneh, večinoma v blato (94 % odmerka).
English: In the 2-year rat carcinogenicity study, the major target organ for non-neoplastic lesions was the uterus (dilatation, vascular ectasia, endothelial cell hyperplasia, inflammation and/or epithelial hyperplasia).
Slovenian: V 2-letni študiji karcinogenosti pri podganah je bila maternica glavni tarčni organ za ne-neoplastične lezije (dilatacija, žilne ektazije, hiperplazija endotelijskih celic, vnetje in/ali hiperplazija epitelija).
English: - Women who might get pregnant are advised to use highly effective contraception during treatment and for up to two weeks after ending treatment.
Slovenian: - Ženskam, ki bi lahko zanosile, se med zdravljenjem in še dva tedna po zaključku zdravljenja priporoča uporaba zelo učinkovite kontracepcijske metode.
English: Among newly diagnosed patients, the percentage of patients who achieved MR4.0 was 32%, while 28.0% achieved MR4.5.
Slovenian: Med novo odkritimi bolniki je bil odstotek bolnikov, ki so dosegli odziv MR4.0,32 %, pri tem pa jih je 28,0 % doseglo odziv MR4.5.
English: Eighty-eight patients (46.3%) discontinued the TFR phase due to loss of MMR, and 1 (0.5%), 1 (0.5%), and 3 patients (1.6%) due to death from unknown cause, physician decision and subject decision, respectively.
Slovenian: Oseminosemdeset bolnikov (46,3 %) je prekinilo fazo remisije brez zdravljenja zaradi izgube odziva MMR, 1 bolnik (0,5 %) je prekinil zaradi smrti iz neznanega vzroka, 1 bolnik (0,5 %) zaradi zdravnikove odločitve, 3 bolniki (1,6 %) pa so to fazo prekinili po svoji odločitvi.
English: In adult patients with newly diagnosed CML in chronic phase The median duration of exposure was 60.5 months (range 0.1-70.8 months).
Slovenian: Pri odraslih bolnikih z novo odkrito KML v kronični fazi Srednja vrednost trajanja izpostavljenosti 60,5 meseca (od 0,1 do 70,8 meseca).
English: Should treatment with any of these agents be required, it is recommended that nilotinib therapy be interrupted if possible (see section 4.5).
Slovenian: Če je potrebno zdravljenje s katerim od teh sredstev, je priporočljivo, če je le mogoče, prekiniti zdravljenje z nilotinibom (glejte poglavje 4.5).
English: In patients for whom CYP3A4 inducers are indicated, alternative agents with less enzyme induction potential should be selected.
Slovenian: Pri bolnikih z indikacijami za zdravljenje z induktorji CYP3A4 je treba izbrati druge učinkovine z manjšo zmožnostjo indukcije encimov.
English: Patients who maintain BCR-ABL levels between MMR and MR4 for a minimum of 4 consecutive measurements can return to the original monitoring schedule.
Slovenian: Bolniki, ki ohranijo raven prepisov BCR-ABL v okviru med odzivoma MMR in MR 4 pri najmanj 4 zaporednih meritvah, lahko ponovno začnejo z osnovnim režimom zdravljenja.
English: The median TFS has not yet been reached (Figure 5); 74 of 126 patients (58.7%) did not have a TFS event.
Slovenian: Mediana trajanja preživetja brez zdravljenja (TFS) ni bila dosežena (slika 5); pri 74 od 126 bolnikov (58,7 %) ni prišlo do TFS dogodka.
English: Nilotinib should be used with caution in patients who have or may develop prolongation of the QT interval, including those patients taking anti-arrhythmic medicinal products such as amiodarone, disopyramide, procainamide, quinidine and sotalol or other medicinal products that may lead to QT prolongation such as chloroquine, halofantrine, clarithromycin, haloperidol, methadone and moxifloxacin (see section 4.4).
Slovenian: Nilotinib je treba uporabljati previdno pri bolnikih, ki podaljšanje intervala QT že imajo ali do njega lahko še pride, med drugim pri bolnikih, ki jemljejo antiaritmična zdravila, kot so amiodaron, dizopiramid, prokainamid, kinidin in sotalol, ali druga zdravila, ki lahko povzročajo podaljšanje intervala QT, kot so klorokin, halofantrin, klaritomicin, haloperidol, metadon in moksifloksacin (glejte poglavje 4.4).
English: If a HMG-CoA reductase inhibitor (a lipid-lowering agent) is required, please refer to section 4.5 before initiating treatment since certain HMG-CoA reductase inhibitors are also metabolised by the CYP3A4 pathway.
Slovenian: Če bolnik potrebuje katerega od zaviralcev reduktaze HMG-CoA (zdravila za zniževanje vrednosti maščob v krvi), še pred začetkom zdravljenja preverite poglavje 4.5, saj se določeni zaviralci reduktaze HMG-CoA prav tako presnavljajo s CYP3A4.
English: If you have questions about when to take this medicine, talk to your doctor or pharmacist.
Slovenian: Če imate vprašanja o tem, kdaj jemati to zdravilo, se pogovorite z zdravnikom ali s farmacevtom.
English: In patients with CML, a change in DNA (genetic material) triggers a signal that tells the body to produce abnormal white blood cells.
Slovenian: Pri bolnikih, ki imajo kronično mieloično levkemijo, pride do spremembe v DNA (genskem zapisu), ki sproži signal, zaradi katerega telo izdeluje nenormalne levkocite.
English: Nilotinib may be used concurrently with esomeprazole or other proton pump inhibitors as needed.
Slovenian: Če je treba, se nilotinib lahko uporablja sočasno z esomeprazolom ali z drugimi zaviralci protonske črpalke.
English: Progression to accelerated phase (AP) or blast crisis (BC) on treatment is defined as the time from the date of randomisation to the first documented disease progression to accelerated phase or blast crisis or CML-related death.
Slovenian: Napredovanje v pospešeno fazo ali blastno krizo v času zdravljenja je opredeljeno s časom od datuma randomizacije do prvega dokumentiranega napredovanja bolezni v pospešeno fazo ali blastno krizo oziroma do smrti zaradi kronične mieloične levkemije (KML).
English: If blood counts remain low, a dose reduction to 400 mg once daily may be required.
Slovenian: Če se krvna slika ne popravi, je morda potrebno znižanje odmerka na 400 mg enkrat dnevno.
English: The majority of patients had a long history of CML that included extensive prior treatment with other antineoplastic agents, including imatinib, hydroxyurea, interferon, and some had even failed organ transplant (Table 11).
Slovenian: Večina bolnikov je imela KML že dolgo in so bili predhodno v veliki meri zdravljeni z drugimi antineoplastičnimi zdravili, vključno z imatinibom, s hidroksiureo, z interferonom, pri nekaterih celo transplantacija kostnega mozga ni bila uspešna (preglednica 11).
English: - Do not take any food together with the hard capsules.
Slovenian: - Skupaj s trdimi kapsulami ne uživajte nobene hrane.
English: Hyperbilirubinaemia (including blood bilirubin increased)
Slovenian: hiperbilirubinemija (vključno z zvišano koncentracijo bilirubina v krvi)
English: - if you have sudden heart palpitations, severe muscle weakness or paralysis, seizures or sudden changes in your thinking or level of alertness, tell your doctor immediately as this may be a sign of a fast breakdown of cancer cells called tumour lysis syndrome.
Slovenian: - če občutite nenadno močno bitje srca, hudo mišično oslabelost ali paralizo, epileptične napade ali nenadne spremembe v zmožnosti mišljenja ali stopnji zavedanja, takoj povejte svojemu zdravniku, saj je to lahko znak hitrega razpada tumorskih celic, ki mu pravimo sindrom tumorske lize.
English: The primary endpoint was the percentage of patients in MMR at 48 weeks after starting the TFR phase (considering any patient who required re-initiation of treatment as non-responder).
Slovenian: Primarni cilj študije je bil odstotek bolnikov, ki so po 48 tednih po začetku faze remisije brez zdravljenja (TFR) v stanju glavnega molekularnega odgovora (MMR) (pri čemer velja vsak bolnik, ki potrebuje ponoven začetek zdravljenja, za neodzivnega).
English: If test results warrant therapy, physicians should follow their local standards of practice and treatment guidelines.
Slovenian: Če bolnik glede na izvide teh preiskav potrebuje zdravljenje, naj zdravniki pri tem upoštevajo lokalne standarde in dogovorjene smernice zdravljenja.