FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy and safety of venetoclax in patients with CLL who had been previously treated with and failed ibrutinib or idelalisib therapy were evaluated in an open-label, multi-center, non-randomised, phase 2 study
Slovenian: Učinkovitost in varnost venetoklaksa pri bolnikih s KLL, predhodno neuspešno zdravljenih z ibrutinibom ali idelalisibom, so ovrednotili v odprti, multicentrični nerandomizirani študiji 2. faze
English: If your doctor thinks that you are at risk of TLS, you may be treated in the hospital so that you can be given extra fluids into the vein if needed, have your blood tests more often and be checked for side effects.
Slovenian: Če vaš zdravnik meni, da pri vas obstaja tveganje za TLS, vas bodo morda zdravili v bolnišnici, da boste lahko prejeli dodatno tekočino v veno, če bo potrebno, pogosteje vam bodo opravljali preiskave krvi in vas spremljali glede neželenih učinkov.
English: Signs may include fever, chills, feeling weak or confused, cough, pain or burning feeling when passing urine.
Slovenian: Znaki lahko vključujejo zvišano telesno temperaturo, mrzlico, občutek šibkosti ali zmedenosti, kašelj, bolečino ali pekoči občutek pri uriniranju.
English: The primary efficacy endpoint was ORR according to IWCLL updated NCI-WG guidelines.
Slovenian: Primarni opazovani dogodek učinkovitost je bil ORR na podlagi smernic NCI-WG v posodobitvi
English: • higher level of a body salt (electrolyte) called phosphate
Slovenian: • povečane vrednosti soli v telesu (elektrolita), imenovane fosfat • nizko vrednost kalcija
English: • feeling short of breath
Slovenian: • občutek kratke sape
English: • If it is less than 8 hours since the time you usually take your dose, take it as soon as possible.
Slovenian: • Če je od časa, ko običajno vzamete vaš odmerek, minilo manj kot 8 ur, ga vzemite čim prej.
English: If a narrow therapeutic index P-gp or BCRP substrate must be used, it should be used with caution.
Slovenian: Če je uporaba P-gp ali BCRP substrata z ozkim terapevtskim indeksom nujna, ga je treba uporabiti previdno.
English: This protein helps cancer cells survive.
Slovenian: Ta beljakovina rakavim celicam pomaga preživeti.
English: Total (N=127)
Slovenian: Skupaj (N = 127)
English: A 17p deletion was detected in 26.9% of patients, TP53 mutations in 26.3%, 11q deletion in 36.5%, and unmutated IgVH gene in 68.3%.
Slovenian: Pri 26,9 % bolnikov je bila ugotovljena 17p delecija, TP53 mutacije pri 26,3 %, delecija 11q pri 36,5 % in nemutirani IgVH gen pri 68,3 %.
English: Post-dose: For patients at risk of TLS, blood chemistries should be monitored at 6 to 8 hours and at 24 hours after the first dose of venetoclax.
Slovenian: Po odmerku: Pri bolnikih, pri katerih obstaja tveganje za TLS, je treba krvne preiskave narediti 6 do 8 ur in 24 ur po prvem odmerku venetoklaksa.
English: - you are taking a herbal medicine called St. John's wort, used for depression.
Slovenian: - jemljete zdravilo rastlinskega izvora iz šentjanževke, ki se uporablja pri depresiji.
English: Venetoclax is a substrate for P-gp and BCRP.
Slovenian: Venetoklaks je substrat za P-gp in BCRP.
English: Tell your doctor if you notice any of the following side effects: Very common
Slovenian: Povejte zdravniku, če opazite katerega od naslednjih neželenih učinkov:
English: The film-coated tablets are supplied in cartons containing either 7 (in blisters of 1 tablet) or 14 tablets (in blisters of 2 tablets); or a multipack containing 112 tablets (4 x 28 tablets (in blisters of 4 tablets)).
Slovenian: Filmsko obložene tablete so pakirane v škatlah, ki vsebujejo 7 (v pretisnih omotih po 1 tableto) ali 14 tablet (v pretisnih omotih po 2 tableti); ali v večkratnem pakiranju, ki vsebuje 112 tablet (4 x 28 tablet (v pretisnih omotih po 4 tablete)).
English: This may lead to changes in kidney function, abnormal heartbeat, or seizures.
Slovenian: To lahko povzroči spremembo v delovanju ledvic, do neenakomernega srčnega utripa ali napada krčev.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX52
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX52 Mehanizem delovanja
English: Patients with reduced renal function (CrCl <80 ml/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase (see “Prevention of tumour lysis syndrome” above).
Slovenian: Bolniki z zmanjšanim delovanjem ledvic (CrCL < 80 ml/min) bodo morda potrebovali bolj intenzivno profilakso in spremljanje, da se zmanjša tveganje za TLS na začetku zdravljenja in med fazo titracije odmerka (glejte »Preprečevanje sindroma tumorske lize« zgoraj).
English: MRD negativity rate at end of combination treatmentb
Slovenian: MRD negativni rezultati ob koncu kombiniranega zdravljenjab
English: The starting dose is 20 mg of venetoclax once daily for 7 days.
Slovenian: Začetni odmerek je 20 mg venetoklaksa enkrat na dan, 7 dni.
English: The next venetoclax dose should not be administered until the 24-hour blood chemistry results have been evaluated.
Slovenian: Naslednjega odmerka venetoklaksa se ne sme dati, dokler niso ocenjeni rezultati preiskave krvi, ki je bila odvzeta 24 ur po prvem odmerku.
English: Laboratory assessments
Slovenian: Laboratorijski izvidi
English: Venetoclax in combination with rituximab for the treatment of patients with CLL who have received at least one prior therapy - study GO28667 (MURANO)
Slovenian: Venetoklaks v kombinaciji z rituksimabom za zdravljenje bolnikov s KLL, ki so predhodno prejeli vsaj eno zdravljenje - študija GO28667 (MURANO)
English: In the open-label, randomised phase 3 study (MURANO), the incidence of TLS was 3% (6/194) in patients treated with venetoclax + rituximab.
Slovenian: V odprti, randomizirani študiji 3. faze (MURANO), je bila pojavnost TLS 3 % (6/194) pri bolnikih zdravljenih z venetoklaksom + rituksimabom.
English: • feeling unusually tired
Slovenian: • občutek nenavadne utrujenosti
English: Mild hepatic impairment was defined as normal total bilirubin and aspartate transaminase (AST) > upper limit of normal (ULN) or total bilirubin >1.0 to 1.5 times ULN, moderate hepatic impairment as total bilirubin >1.5 to 3.0 times ULN, and severe hepatic impairment as total bilirubin >3.0 ULN.
Slovenian: Blaga okvara jeter je bila opredeljena kot normalen celokupni bilirubin in aspartat-transaminaza (AST) nad zgornjo normalno mejo (ZNM) ali kot celokupni bilirubin > 1,0- do 1,5-kratna ZNM, zmerna okvara kot celokupni bilirubin > 1,5- do 3,0kratna ZNM in huda okvara jeter kot celokupni bilirubin > 3,0-kratna ZNM.
English: Also some other medicines can affect the way Venclyxto works.
Slovenian: Tudi druga zdravila lahko vplivajo na način delovanja zdravila Venclyxto.
English: Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Slovenian: Zdravilo Venclyxto v kombinaciji z rituksimabom je indicirano za zdravljenje odraslih bolnikov s kronično limfocitno levkemijo (KLL), ki so predhodno prejeli vsaj eno zdravljenje.
English: Based on embryo-foetal toxicity studies in animals (see section 5.3), venetoclax may harm the foetus when administered to pregnant women.
Slovenian: Nosečnost Na podlagi študij embriofetalne toksičnosti na živalih (glejte poglavje 5.3) lahko venetoklaks, če se ga da nosečnicam, škoduje plodu.
English: Based on testicular toxicity in dogs at clinically relevant exposures, male fertility may be compromised by treatment with venetoclax (see section 5.3).
Slovenian: Na podlagi toksičnosti za testise pri psih pri klinično pomembni izpostavljenosti lahko zdravljenje z venetoklaksom vpliva na plodnost pri moških (glejte poglavje 5.3).
English: Substrates of P-gp, BCRP, and OATP1B1
Slovenian: Substrati P-gp, BCRP in OATP1B1
English: Blood chemistry (potassium, uric acid, phosphorus, calcium, and creatinine) should be assessed and pre-existing abnormalities corrected.
Slovenian: Oceniti je treba rezultate krvnih preiskav (kalij, sečna kislina, fosfor, kalcij in kreatinin) in popraviti obstoječe nepravilnosti.
English: In the initial Phase 1 dose-finding studies, which had a shorter (2 to 3 week) titration phase and higher starting dose, the incidence of TLS was 13% (10/77; 5 laboratory TLS; 5 clinical TLS), including 2 fatal events and 3 events of acute renal failure, 1 requiring dialysis.
Slovenian: začetni 1. fazi študij za določanje odmerka, ki so imele krajšo fazo titracije (2 do 3 tedne) in večji začetni odmerek, je bila pojavnost TLS 13 % (10/77; 5 laboratorijskih TLS; 5 kliničnih TLS), vključno z 2 smrtnima primeroma in 3 primeri akutne odpovedi ledvic, 1 od teh je zahteval dializo.
English: This is called tumour lysis syndrome (TLS).
Slovenian: To se imenuje sindrom tumorske lize (TLS- tumour lysis syndrome).
English: • itraconazole ketoconazole, posaconazole, or voriconazole for fungal infections
Slovenian: • itrakonazol, ketokonazol, posakonazol ali vorikonazol za zdravljenje glivičnih okužb,
English: Based on physician assessment, some patients, especially those at greater risk of TLS, may require hospitalisation on the day of the first dose of venetoclax for more intensive prophylaxis and monitoring during the first 24 hours (see section 4.8).
Slovenian: Nekateri bolniki, še posebno tisti pri katerih obstaja večje tveganje za TLS, bodo na podlagi ocene zdravnika, na dan, ko bodo prejeli prvi odmerek venetoklaksa, morda potrebovali hospitalizacijo za intenzivnejšo profilakso in spremljanje v prvih 24 urah (glejte poglavje 4.8).
English: It is not known whether the active substance in Venclyxto passes into breast milk.
Slovenian: Ni znano ali učinkovina v zdravilu Venclyxto prehaja v materino mleko.
English: You should start drinking at least 1.5 to 2 litres of water daily two days before starting Venclyxto.
Slovenian: Začnite s pitjem vsaj 1,5 do 2 litrov vode na dan dva dni pred začetkom zdravljenja z zdravilom Venclyxto.
English: Patients should be monitored more closely for signs of toxicities (see sections 4.4 and 4.5).
Slovenian: Bolnike je treba bolj skrbno spremljati glede znakov toksičnosti (glejte poglavji 4.4 in 4.5).
English: Venetoclax is predominantly metabolised by CYP3A.
Slovenian: Venetoklaks se presnavlja predvsem s CYP3A.
English: Efficacy results for PFS at the time of pre-specified primary analysis (data cut-off date 8 May 2017) are shown in Table 4.
Slovenian: Rezultati učinkovitosti za preživetje brez napredovanja bolezni v času vnaprej določene primarne analize (upoštevani so podatki do 8. maja 2017) so prikazani v tabeli 4.
English: At the time of evaluation, median duration of treatment with venetoclax was 14.3 months (range: 0.1 to 31.4 months).
Slovenian: Ob času ovrednotenja je zdravljenje z venetoklaksom mediano trajalo 14,3 mesecev (razpon: od 0,1 do 31,4 mesecev).
English: Blood creatinine increased aOnly the highest frequency observed in the trials is reported (based on studies MURANO, M13-982, M14032, and M12-175).
Slovenian: Preiskave pogosti povečana vrednost kreatinina v krvi občasni povečana vrednost kreatinina v krvi aPoroča se samo o najvišji frekvenci, ugotovljeni v preskušanjih (na podlagi študij MURANO, M13-982, M14-032 in M12-175).
English: Venetoclax steady state AUC increased proportionally over the dose range of 150-800 mg.
Slovenian: AUC venetoklaksa se je v stanju dinamičnega ravnovesja v razponu odmerkov od 150 do 800 mg povečevala sorazmerno.
English: In venetoclax clinical studies, patients with any measurable lymph node ≥10 cm or those with both an ALC ≥25 x 109/l and any measurable lymph node ≥5 cm were hospitalised to enable more intensive hydration and monitoring for the first day of dosing at 20 mg and 50 mg during the titration phase (see section 4.2).
Slovenian: V kliničnih študijah z venetoklaksom so bili bolniki s katero koli bezgavko, ki je merila ≥ 10 cm, ali tisti z ALC ≥ 25 x 109/l in katero koli bezgavko, ki je merila ≥ 5 cm, hospitalizirani, da je bila možna intenzivnejša hidracija in spremljanje na prvi dan odmerjenja 20 mg in 50 mg med fazo titracije (glejte poglavje 4.2).
English: Eighteen patients in the venetoclax + rituximab arm and 3 patients in the bendamustine + rituximab arm had negative bone marrow and lymph nodes <2 cm. bMinimal residual disease was evaluated using allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry.
Slovenian: Osemnajst bolnikov v skupini venetoklaks + rituksimab in 3 bolniki v skupini bendamustin + rituksimab je imelo negativne rezultate po izvidu kostnega mozga in limfne vozle <2 cm. bMinimalna rezidualna bolezen je bila ovrednotena z verižno reakcijo z alel-specifično oligonukleotidno polimerazo (ASO-PCR) in/ali s pretočno citometrijo.
English: Patients continued to receive venetoclax 400 mg once daily until disease progression or unacceptable toxicity was observed.
Slovenian: Bolniki so nato prejemali 400 mg venetoklaksa enkrat na dan do napredovanja bolezni ali pojava nesprejemljivih toksičnih učinkov.
English: Co-administration of bile acid sequestrants with venetoclax is not recommended as this may reduce the absorption of venetoclax.
Slovenian: Sočasno dajanje izmenjevalcev žolčnih kislin z venetoklaksom ni priporočljivo, saj lahko zmanjša absorpcijo venetoklaksa.
English: The risk may decrease as tumour burden decreases with venetoclax treatment (see section 4.4).
Slovenian: Tveganje se lahko zmanjša z zmanjšanjem tumorske obremenitve pri zdravljenju z venetoklaksom (glejte poglavje 4.4).
English: You will begin treatment with Venclyxto at a low dose for 1 week.
Slovenian: Zdravljenje z zdravilom Venclyxto boste začeli z majhnim odmerkom, kar bo trajalo 1 teden.
English: • you are due to have a vaccine.
Slovenian: • boste cepljeni.
English: Venclyxto is a cancer medicine that contains the active substance venetoclax.
Slovenian: Zdravilo Venclyxto je zdravilo za zdravljenje raka, ki vsebuje učinkovino venetoklaks.
English: - Do not get pregnant while you are taking this medicine.
Slovenian: Nosečnost - Ne zanosite med jemanjem tega zdravila.
English: Tumour lysis syndrome is an important identified risk when initiating venetoclax.
Slovenian: Sindrom tumorske lize Sindrom tumorske lize je pomembno ugotovljeno tveganje ob začetku zdravljenja z venetoklaksom.
English: aThe discrepancy between IRC- and investigator-assessed CR rate was due to interpretation of residual adenopathy on CT scans.
Slovenian: aRazlika med CR vrednostjo ocenjeno s strani IRC in tisto s strani raziskovalca je bila posledica interpretacije preostale adenopatije pri računalniški tomografiji (CT).
English: Grade 3 or 4 neutropenia has been reported in patients treated with venetoclax in the combination study with rituximab (GO28667/MURANO) and in the monotherapy studies (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z venetoklaksom, so poročali o nevtropeniji 3. ali 4. stopnje v kombinirani študiji z rituksimabom (GO28667/MURANO) in v študijah z monoterapijo (glejte poglavje 4.8).
English: Rituximab was initiated after the 5-week dose-titration schedule at 375 mg/m2 for Cycle 1 and 500 mg/m2 for Cycles 26.
Slovenian: Rituksimab so začeli prejemati po 5-tedenski shemi titriracije odmerka pri 375 mg/m2 za 1. cikel in 500 mg/m2 pri ciklusih 2-6.
English: Testicular toxicity (germ cell loss) was observed in general toxicity studies in dogs at exposures of 0.5 to 18 times the human AUC exposure at the recommended dose.
Slovenian: Toksičnost za moda (izguba zarodnih celic) je bila opažena v splošnih študijah toksičnosti pri psih pri 0,5- do 18-kratni izpostavljenosti glede na izpostavljenost pri človeku (AUC) ob uporabi priporočenega odmerka.
English: Venetoclax is not expected to inhibit OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1 or MATE2K at clinically relevant concentrations.
Slovenian: Ni pričakovati, da bi venetoklaks v klinično pomembni koncentraciji zaviral OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1 ali MATE2K.
English: In embryo-foetal development studies in mice, venetoclax was associated with increased post-implantation loss and decreased foetal body weight at exposures of 1.1 times the human AUC exposure at the recommended dose.
Slovenian: V študijah embrio-fetalnega razvoja pri miših je bil venetoklaks povezan z večjo postimplantacijsko izgubo in zmanjšanjem mase telesa ploda pri 1,1-kratni izpostavljenosti glede na izpostavljenost pri človeku (AUC) ob uporabi priporočenega odmerka.
English: Contents of the pack and other information What Venclyxto contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Venclyxto
English: o When you are receiving Venclyxto therapy in combination with rituximab, you will receive the 400 mg daily dose for 24 months.
Slovenian: o Če jemljete zdravilo Venclyxto v kombinaciji z rituksimabom, boste jemali 400 mg dnevni odmerek 24 mesecev.
English: Of the 107 patients who were evaluated for efficacy from M13-982 study, 57% were 65 years or older.
Slovenian: Med 107 bolniki, pri katerih so v študiji M13-982 ocenjevali učinkovitost, je bilo 57 % starih 65 let ali več.
English: TTR, months, median (range)
Slovenian: TTR, meseci, mediana (razpon)
English: Serious infections including events of sepsis with fatal outcome have been reported.
Slovenian: Poročali so o resnih okužbah, vključno s pojavom sepse, s smrtnim izidom.
English: Prevention of tumour lysis syndrome (TLS)
Slovenian: Preprečevanje sindroma tumorske lize (TLS - Tumour Lysis Syndrome)
English: Venetoclax is not an inhibitor of UGT1A4, UGT1A6, UGT1A9 and UGT2B7.
Slovenian: Venetoklaks ne zavira UGT1A4, UGT1A6, UGT1A9 ali UGT2B7.
English: Venclyxto monotherapy is indicated for the treatment of CLL:
Slovenian: Zdravilo Venclyxto kot monoterapija je indicirano za zdravljenje KLL:
English: Concomitant use of venetoclax with P-gp and BCRP inhibitors at initiation and during the dose-titration phase should be avoided; if a P-gp and BCRP inhibitor must be used, patients should be monitored closely for signs of toxicities (see section 4.4).
Slovenian: Sočasni uporabi venetoklaksa z zaviralci P-gp in BCRP na začetku in med fazo titracije odmerka se je potrebno izogibati; če je uporaba zaviralcev P-gp in BCRP nujna, je treba bolnike skrbno spremljati glede znakov toksičnosti (glejte poglavje 4.4).
English: • 112 (4 x 28) tablets (4 cartons of 7 blisters each with 4 tablets).
Slovenian: • 112 (4 x 28) tablet (4 škatle s 7 pretisnimi omoti s po 4 tabletami).
English: Median OS and DOR were not reached with median follow-up of approximately 14.3 months for Arm A and 14.7 months for Arm B.
Slovenian: Mediana OS (čas celokupnega preživetja) in DOR (trajanje odziva) nista bila dosežena v času spremljanja v približno 14,3 mesecih (mediana) za skupino A in 14,7 mesecih (mediana) za skupino B.
English: Dose-titration schedule
Slovenian: Shema titracije odmerka
English: Tumour lysis syndrome, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with venetoclax.
Slovenian: Do sindroma tumorske lize, vključno s smrtnimi dogodki, je prišlo pri bolnikih s predhodno zdravljeno KLL in veliko tumorsko obremenitvijo, ko so bili zdravljeni z venetoklaksom.
English: Venclyxto works by blocking a protein in the body called “BCL-2”.
Slovenian: Zdravilo Venclyxto deluje tako, da v telesu zavira beljakovino, imenovano “BCL-2”.
English: Prior to initiating venetoclax, tumour burden assessment, including radiographic evaluation (e.g., CT scan), must be performed for all patients.
Slovenian: Pred začetkom zdravljenja z venetoklaksom je treba pri vseh bolnikih narediti oceno tumorske obremenitve, vključno z radiografskim vrednotenjem (npr. posnetek z računalniško tomografijo (CT)).
English: Preparations containing St. John's wort are contraindicated during treatment with venetoclax, as efficacy may be reduced (see section 4.3).
Slovenian: Preparati, ki vsebujejo šentjanževko, so med zdravljenjem z venetoklaksom kontraindicirani, ker je učinkovitost lahko zmanjšana (glejte poglavje 4.3).
English: Concomitant use of venetoclax with strong or moderate CYP3A4 inducers should be avoided (see sections 4.3 and 4.5).
Slovenian: Sočasni uporabi venetoklaksa z močnimi ali zmernimi induktorji CYP3A4 se je potrebno izogibati (glejte poglavji 4.3 in 4.5).
English: Before starting treatment, counselling on sperm storage may be considered in some male patients.
Slovenian: Pred začetkom zdravljenja se je pri nekaterih moških bolnikih smiselno posvetovati o shranitvi semenske tekočine.
English: The median time on treatment at the time of evaluation was 12 months (range: 0 to 22 months).
Slovenian: Mediani čas zdravljenja je bil ob času ovrednotenja 12 mesecev (razpon: od 0 do 22 mesecev).
English: If a moderate CYP3A inhibitor must be used, the initiation and titration doses of venetoclax should be reduced by at least 50%.
Slovenian: Če je uporaba zmernega zaviralca CYP3A nujna, je treba začetne in titracijske odmerke venetoklaksa zmanjšati za vsaj 50 %.
English: Venetoclax shows minimal accumulation with accumulation ratio of 1.30-1.44.
Slovenian: Kopičenje venetoklaksa je minimalno; razmerje kopičenja je od 1,30 do 1,44.
English: • If it is more than 8 hours since the time you usually take your dose, do not take the dose that day.
Slovenian: • Če je od časa, ko običajno vzamete vaš odmerek, minilo več kot 8 ur, ta dan ne vzemite odmerka.
English: It is recommended that venetoclax should be administered with a meal (see section 4.2).
Slovenian: Venetoklaks je priporočljivo jemati med obrokom (glejte poglavje 4.2).
English: The safety and efficacy of venetoclax in 107 patients with previously treated CLL with 17p deletion were evaluated in a single arm, open-label, multi-center study (M13-982).
Slovenian: Varnost in učinkovitost venetoklaksa pri 107 bolnikih s predhodno zdravljeno KLL z delecijo 17p so proučili v odprti, multicentrični študiji z eno samo skupino (M13-982).
English: The ORR for patients with 17p deletion and/or TP53 mutation was 72% (33/46) (95% CI: 56.5, 84.0) in Arm A and 67% (8/12) (95% CI: 34.9, 90.1) in Arm B. For patients without 17p deletion and/or TP53 mutation, the ORR was 69% (31/45) (95% CI: 53.4, 81.8) in Arm A and 71% (17/24) (95% CI: 48.9, 87.4) in Arm B.
Slovenian: ORR za bolnike z 17p delecijo in/ali TP53 mutacijo je bil 72 % (33/46) (95 % IZ: 56.5, 84.0) v skupini A in 67 % (8/12) (95 % IZ: 34.9, 90.1) v skupini B. Za bolnike brez 17p delecije in/ali TP53 mutacije pa je bil ORR 69 % (31/45) (95 % IZ: 53.4, 81.8) v skupini A in 71 % (17/24) (95 % IZ: 48.9, 87.4) v skupini B.
English: aThe modified dose should be continued for 1 week before increasing the dose.
Slovenian: a S prilagojenim odmerkom je treba nadaljevati 1 teden,
English: If you are at risk of TLS you may be treated in hospital so that you can be given fluids into the vein if needed, have blood tests done more often and to check for side effects.
Slovenian: Če pri vas obstaja tveganje za TLS vas bodo morda zdravili v bolnišnici, tako da boste, če bo potrebno, lahko prejeli tekočine v veno, pogosteje vam bodo opravljali preiskave krvi in vas spremljali glede neželenih učinkov.
English: The M27 metabolite was negative for genotoxicity in the bacterial mutagenicity and chromosomal aberration assays.
Slovenian: Presnovek M27 je bil negativen glede genotoksičnosti v preizkusu mutagenosti pri bakterijah in preizkusu kromosomskih aberacij.
English: Median follow-up time for primary analysis was 23.8 months (range: 0.0 to 37.4 months).
Slovenian: Mediana spremljanja primarne analize je bila 23,8 mesecev (razpon: 0,0 do 37,4 mesecev).
English: Of the patients, 37% (34/91) were fludarabine refractory, 81% (30/37) harboured the unmutated IgVH gene, and 72% (60/83) had TP53 mutation.
Slovenian: Med bolniki je bilo 37 % (34/91) odpornih proti fludarabinu, 81 % (30/37) jih je imelo nemutiran gen IgVH in 72 % (60/83) jih je imelo mutacijo TP53.
English: No clinical TLS was observed in patients who followed the current 5-week dose-titration schedule and TLS prophylaxis and monitoring measures (see section 4.2).
Slovenian: Pri bolnikih, ki so sledili sedanji 5-tedenski shemi titracije odmerka in profilaksi TLS ter ukrepom spremljanja, niso opazili nobenega kliničnega TLS (glejte poglavje 4.2).