FrancophonIA/ELRC3.0 huggingface dataset:
English: Venetoclax can cause rapid reduction in tumour, and thus poses a risk for TLS in the initial 5-week dose-titration phase.
Slovenian: Venetoklaks lahko povzroči hitro zmanjšanje tumorja in tako predstavlja tveganje za TLS v začetni 5
English: In non-clinical studies, venetoclax has demonstrated cytotoxic activity in tumour cells that overexpress BCL-2.
Slovenian: V predkliničnih študijah je venetoklaks izkazal citotoksično aktivnost v tumorskih celicah s prekomerno izraženim BCL-2.
English: Chromosomal aberrations were 11q deletion (34%, 43/127), 17p deletion (40%, 50/126), TP53 mutation (38%, 26/68) and unmutated IgVH (78%, 72/92).
Slovenian: Kromosomske aberacije so bile delecija 11q (34 %,43/127), delecija 17p (40 %, 50/126), mutacija TP53 (38 %, 26/68) in nemutiran IgVH (78 %, 72/92).
English: M27 was identified as a major metabolite in plasma with an inhibitory activity against BCL-2 that is at least 58-fold lower than venetoclax in vitro.
Slovenian: Glavni presnovek v plazmi je M27; njegovo inhibicijsko delovanje na BCL-2 je in vitro vsaj 58-krat manjše od venetoklaksa.
English: The most frequently reported serious adverse reactions (≥2%) in patients receiving venetoclax in combination with rituximab were pneumonia, febrile neutropenia, and TLS.
Slovenian: Najpogosteje poročani resni neželeni učinki (≥ 2 %) pri bolnikih, ki so prejemali venetoklaks v kombinaciji z rituksimabom, so bili pljučnica, vročinska nevtropenija in TLS .
English: Agents that may have their plasma concentrations altered by venetoclax
Slovenian: Učinkovine, katerih koncentracije v plazmi se lahko spremenijo zaradi venetoklaksa
English: Overall, 65% of patients received prior nucleoside analogue, 86% rituximab, 39% other monoclonal antibodies, and 72% alkylating agent (including 41% with bendamustine).
Slovenian: V celoti je 65 % bolnikov predhodno prejemalo nukleozidni analog, 86% rituksimab, 39 % druga monoklonska protitelesa in 72 % alkilirajoče sredstvo (vključno 41 %, ki so prejemali bendamustin).
English: Cardiac electrophysiology
Slovenian: Farmakodinamični učinki Srčna elektrofiziologija
English: Rituximab should be administered after the patient has completed the dose-titration schedule and has received the recommended daily dose of 400 mg venetoclax for 7 days.
Slovenian: Rituksimab je treba uporabiti po tem, ko je bolnik zaključil s titracijo odmerka po shemi in je 7 dni prejemal priporočeni dnevni odmerek 400 mg venetoklaksa.
English: • in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
Slovenian: • z odsotno delecijo 17p ali mutacijo TP53 pri odraslih bolnikih, pri katerih tako kemoimunoterapija kot zdravljenje z zaviralcem receptorske poti celic B ni bilo uspešno.
English: 27.2 (21.9, NR)
Slovenian: 27,2 (21,9, ND)
English: • lower number of white blood cells called lymphocytes
Slovenian: • nizko število belih krvnih celic, imenovanih limfociti
English: A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter se priporoča zmanjšanje odmerka za vsaj 50 % skozi celotno obdobje zdravljenja (glejte poglavje 5.2).
English: Twenty-five percent (32/127) of patients were MRD negative in the peripheral blood, including 8 patients who were also MRD negative in bone marrow.
Slovenian: Petindvajset odstotkov (32/127) bolnikov je bilo MRD-negativnih po izvidu periferne krvi, vključno z 8 bolnikov, ki so bili MRD-negativen tudi po izvidu kostnega mozga.
English: In vitro studies demonstrated that venetoclax is predominantly metabolised by cytochrome P450 CYP3A4.
Slovenian: Študije in vitro kažejo, da se venetoklaks presnavlja predvsem s citokromom P450 3A4 (CYP3A4).
English: At an updated efficacy analysis with all patients off treatment (data cut-off date 8 May 2018 and median follow-up of 36 months) the 36-month PFS estimate in the venetoclax + rituximab arm was 71.4% [95% CI: 64.8, 78.1] and in the bendamustine + rituximab arm was 15.2% [95% CI: 9.1, 21].
Slovenian: Pri posodobljeni analizi učinkovitosti pri vseh bolnikih po zaključenem zdravljenju (upoštevani so podatki do 8. maja 2018 in mediana spremljanja 36 mesecev), je bila 36-mesečna ocena PFS v skupini, ki je prejemala venetoklaks + rituksimab 71,4 % [95 % IZ: 64,8, 78,1], v skupini, ki je prejemala bendamustin + rituksimab pa 15,2 % [95 % IZ: 9,1, 21].
English: Initiation and titration phase
Slovenian: Začetek zdravljenja in faza titracije
English: ORR, % (95% CI) CR + CRi, % nPR, %
Slovenian: ORR, % (95 % IZ) CR + CRi, % nPR, %
English: Venetoclax is a potent, selective inhibitor of B-cell lymphoma (BCL)-2, an anti-apoptotic protein.
Slovenian: Venetoklaks je močan, selektiven zaviralec anti-apoptotične beljakovine limfoma celic B (BCL)-2.
English: Twenty-seven percent (42/158) of patients were MRD negative in the peripheral blood, including 16 patients who were also MRD negative in the bone marrow.
Slovenian: Sedemindvajset odstotkov (42/158) bolnikov je bilo MRD-negativnih po izvidu periferne krvi, vključno s 16 bolniki, ki so bili MRD-negativni tudi po izvidu kostnega mozga.
English: In the phase 2 and phase 1 studies, 352 patients with previously treated CLL, which included 212 patients with 17p deletion and 146 patients who had failed a B-cell receptor pathway inhibitor were treated with venetoclax monotherapy (see section 5.1).
Slovenian: V študijah 1. faze in 2. faze je bilo 352 bolnikov s predhodno zdravljeno KLL zdravljenih z venetoklaksom v monoterapiji, vključno s 212 bolniki z delecijo 17p in 146 bolniki, pri katerih zdravljenje z zaviralcem receptorske poti celic B ni bilo uspešno.
English: The recommended dose of venetoclax in combination with rituximab is 400 mg once daily (see section 5.1 for details of the combination regimen).
Slovenian: Odmerjanje venetoklaksa v kombinaciji z rituksimabom po titraciji Priporočeni odmerek venetoklaksa v kombinaciji z rituksimabom je 400 mg enkrat na dan (za podrobnosti o kombiniranem režimu zdravljenja glejte poglavje 5.1).
English: Your doctor may change your dose of Venclyxto.
Slovenian: Zdravnik lahko spremeni vaš odmerek zdravila Venclyxto.
English: Table 3: Adverse drug reactions reported in patients with CLL treated with venetoclax
Slovenian: Preglednica 3: Neželeni učinki, o katerih so poročali pri bolnikih s KLL, ki so se zdravili z venetoklaksom
English: Following multiple oral administrations, maximum plasma concentration of venetoclax was reached 5-8 hours after dose.
Slovenian: Po večkratnem peroralnem dajanju je venetoklaks dosegel največjo koncentracijo v plazmi v 5 do8 urah po odmerku.
English: For an orally administered P-gp or BCRP substrate sensitive to inhibition in the gastrointestinal tract (e.g., dabigatran exetilate), its administration should be separated from venetoclax administration as much as possible to minimise a potential interaction.
Slovenian: Peroralno dajan P-gp ali BCRP substrat, ki je občutljiv na inhibicijo v gastrointestinalnem traktu (npr. dabigatraneteksilat), mora biti dan kolikor se da ločeno od dajanja venetoklaksa, da se s tem zmanjša možno interakcijo.
English: Figure 2: Kaplan-Meier curves of overall survival (intent-to-treat population) in MURANO
Slovenian: Slika 2:Krivulji Kaplan-Meier za vrednosti celokupnega preživetja (vsi bolniki, predvideni za zdravljenje) v študiji MURANO
English: Patients with moderate hepatic impairment should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase (see section 4.8).
Slovenian: Bolnike z zmerno okvaro jeter je treba bolj skrbno spremljati glede znakov toksičnosti na začetku zdravljenja in med fazo titracije odmerka (glejte poglavje 4.8).
English: Venetoclax as monotherapy for the treatment of patients with CLL harbouring 17p deletion or TP53 mutation - study M13-982
Slovenian: Venetoklaks kot monoterapija za zdravljenje bolnikov s KLL in delecijo 17p ali mutacijo TP53študija M13-982
English: - Tell your doctor immediately if you become pregnant while you are taking this medicine.
Slovenian: - Takoj obvestite zdravnika, če zanosite med jemanjem tega zdravila.
English: If you take more Venclyxto than you should, talk to your doctor, pharmacist, or nurse or go to hospital immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Venclyxto, kot bi smeli Če ste vzeli večji odmerek zdravila Venclyxto, kot bi smeli, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro oziroma pojdite takoj v bolnišnico.
English: If a bile acid sequestrant is to be co-administered with venetoclax, the SmPC for the bile acid sequestrant should be followed to reduce the risk for an interaction, and venetoclax should be administered at least 4-6 hours after the sequestrant.
Slovenian: Če se izmenjevalce žolčnih kislin daje sočasno z ventoklaksom, je potrebno upoštevati povzetek glavnih značilnosti zdravila za izmenjevalce žolčnih kislin, da se zmanjša tveganje za interakcijo, venetoklaks pa je potrebno dati vsaj 4-6 ur po izmenjevalcu.
English: • in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
Slovenian: • s prisotno delecijo 17p ali mutacijo TP53 pri odraslih bolnikih, ki niso primerni za zdravljenje z zaviralcem receptorske poti celic B oziroma pri katerih zdravljenje ni bilo uspešno, ali
English: For patients who are on a steady daily dose of Venclyxto, the venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors.
Slovenian: Pri bolnikih, ki so na stalnem dnevnem odmerku venetoklaksa, je treba odmerek zdravila Venclyxto zmanjšati za 50 % pri sočasni uporabi z zmernimi zaviralci CYP3A in za 75 % pri sočasni uporabi z močnimi zaviralci CYP3A.
English: Blood chemistries should be monitored and abnormalities managed promptly.
Slovenian: Rezultate krvnih preiskav je treba spremljati in ob nepravilnostih takoj ustrezno ukrepati.
English: Peripheral blood, % (95% CI)c
Slovenian: Periferna kri, % (95 % IZ)c
English: The active substance is venetoclax.
Slovenian: Učinkovina je venetoklaks.
English: In the MURANO study, dose interruptions due to adverse reactions occurred in 71% of patients treated with the combination of venetoclax and rituximab; the most common adverse reaction that led to dose interruption of venetoclax was neutropenia (43%).
Slovenian: V študiji MURANO je prišlo do prekinitve odmerka zaradi neželenih učinkov pri 71 % bolnikov zdravljenih s kombinacijo venetoklaksa in rituksimaba; najpogostejši neželeni učinek, ki je povzročil prekinitev odmerka venetoklaksa, je bila nevtropenija (43%).
English: In total, 130 patients in the venetoclax + rituximab arm completed 2 years of venetoclax treatment without progression.
Slovenian: V skupini venetoklaks + rituksimab je skupno 130 bolnikov zaključilo 2 letno zdravljenje z venetoklaksom brez napredovanja.
English: If a patient misses a dose of venetoclax within 8 hours of the time it is usually taken, the patient should take the missed dose as soon as possible on the same day.
Slovenian: Če bolnik izpusti odmerek venetoklaksa in od časa, ko ga običajno vzame, ni minilo več kot 8 ur, naj izpuščeni odmerek vzame čim prej še isti dan.
English: Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax as they contain inhibitors of CYP3A.
Slovenian: Med zdravljenjem z venetoklaksom se je treba izogibati izdelkom iz grenivke, seviljskim pomarančam in zvezdnemu sadežu (karamboli), ker vsebujejo zaviralce CYP3A.
English: o When you are receiving Venclyxto therapy alone, you will stay on the 400 mg daily dose, which is the standard dose, for as long as necessary.
Slovenian: o Če jemljete zdravilo Venclyxto samo, 400 mg dnevni odmerek, ki je standarni odmerek,
English: Other medicines and Venclyxto
Slovenian: Druga zdravila in zdravilo Venclyxto
English: • Do not chew, crush, or break the tablets
Slovenian: • tablet ne žvečite, drobite ali lomite
English: Based on population pharmacokinetic analysis, gastric acid reducing agents (e.g., proton pump inhibitors, H2-receptor antagonists, antacids) do not affect venetoclax bioavailability.
Slovenian: Učinkovine, ki zmanjšajo kislost želodčne vsebine Glede na analizo populacijske farmakokinetike, učinkovine, ki zmanjšajo kislost želodčne vsebine (npr. zaviralci protonske črpalke, antagonisti receptorjev H2, antacidi), ne vplivajo na biološko razpoložljivost venetoklaksa.
English: The pharmacokinetics of venetoclax has not been studied in subjects with severe renal impairment (CrCl <30 ml/min) or patients on dialysis (see section 4.2).
Slovenian: Farmakokinetike venetoklaksa niso raziskali pri bolnikih s hudo okvaro ledvic (CrCL < 30 ml/min) in tudi ne pri bolnikih na dializi (glejte poglavje 4.2).
English: Reduced renal function (CrCl <80 ml/min) further increases the risk.
Slovenian: [CrCL] <80 ml/min) dodatno poveča tveganje.
English: Figure 1: Kaplan-Meier curves of investigator-assessed progression-free survival (intent-to-treat population) in MURANO (data cut-off date 8 May 2018)
Slovenian: Slika 1: Krivulji Kaplan-Meier za vrednosti preživetja brez napredovanja bolezni ocenjene s strani raziskovalca (vsi bolniki predvideni za zdravljenje) v študiji MURANO (upoštevani so podatki do 8. maja 2018)
English: Venclyxto film-coated tablets are for oral use.
Slovenian: Način uporabe Filmsko obložene tablete zdravila Venclyxto so za peroralno uporabo.
English: Bendamustine + rituximab N = 195
Slovenian: bendamustine + rituksimab N = 195
English: Progression-free survival (PFS) was assessed by investigators using the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
Slovenian: Chronic Lymphocytic Leukaemia - IWCLL) in posodobljene smernice (2008) delovne skupine, ki jo sponzorira nacionalni inštitut za raka (National Cancer Institute-sponsored Working Group - NCIWG).
English: Discontinuation and dose reductions due to adverse reactions Discontinuations due to adverse reactions occurred in 16% of patients treated with the combination of venetoclax and rituximab in the MURANO study.
Slovenian: Prekinitev zdravljenja in zmanjšanje odmerka zaradi neželenih učinkov Do prekinitve zdravljenja zaradi neželenih učinkov je prišlo pri 16 % bolnikov zdravljenih s kombinacijo venetoklaksa in rituksimaba v MURANO študiji.
English: In subjects with severe (Child-Pugh C; n=5) hepatic impairment, the mean venetoclax Cmax was similar to subjects with normal hepatic function but venetoclax AUCinf was on average 2.7-fold higher (range: no change to 5-fold higher) than venetoclax AUCinf in the subjects with normal hepatic function (see section 4.2).
Slovenian: Pri preiskovancih s hudo jetrno okvaro (Child-Pugh C; n=5), je bila srednja Cmax venetoklaksa podobna kot pri preiskovancih z normalnim delovanjem jeter, vendar je bila AUCinf venetoklaksa v povprečju 2,7-krat višja (razpon: ni prišlo do 5-kratnega zvišanja vrednosti) kot AUCinf venetoklaksa pri preiskovancih z normalnim delovanjem jeter (glejte poglavje 4.2).
English: Macrogol 3350 (E1521) Talc (E553b)
Slovenian: makrogol 3350 (E1521), smukec (E553b).
English: For patients who have completed the dose-titration phase and are on a steady daily dose of venetoclax, the venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors.
Slovenian: Pri bolnikih, ki so končali fazo titracije odmerka in so na stalnem dnevnem odmerku venetoklaksa, je treba odmerek venetoklaksa ob sočasni uporabi z zmernimi zaviralci CYP3A zmanjšati za 50 % in ob sočasni uporabi z močnimi zaviralci CYP3A za 75 %.
English: Dosage reductions due to adverse reactions occurred in 15% of patients treated with the combination of venetoclax and rituximab in the MURANO study and 14% of patients treated with venetoclax in the monotherapy studies.
Slovenian: Do zmanjšanja odmerka zaradi neželenih učinkov je prišlo pri 15 % bolnikov zdravljenih s kombinacijo venetoklaksa in rituksimaba v MURANO študiji in pri 14 % bolnikov zdravljenih z venetoklaksom v študijah z monoterapijo.
English: No dose adjustment is recommended in patients with mild or moderate hepatic impairment.
Slovenian: Prilagoditev odmerka pri bolnikih z blago ali zmerno okvaro jeter ni priporočljiva.
English: • abdominal pain and distension
Slovenian: • bolečina v trebuhu in napihnjenost
English: The median number of prior oncology treatments was 4 (range: 1 to 15) in ibrutinib-treated patients and 3 (range: 1 to 11) in idelalisib-treated patients.
Slovenian: Pri bolnikih, zdravljenih z ibrutinibom, je bilo mediano število predhodnih onkoloških zdravljenj 4 (razpon: od 1 do 15 zdravljenj), pri bolnikih, zdravljenih z idelalisibom, pa 3 (razpon: od 1 do 11 zdravljenj).
English: The median time since diagnosis was 8.3 years (range: 0.3 to 18.5 years; N=96).
Slovenian: Mediani čas od diagnoze je bil 8,3 let (razpon: od 0,3 do 18,5 let, N = 96).
English: Co-administration of narrow therapeutic index P-gp, or BCRP substrates (e.g., digoxin, dabigatran, everolimus, sirolimus) with venetoclax should be avoided.
Slovenian: Sočasnemu dajanju P-gp ali BCRP substratov z ozkim terapevtskim indeksom (npr. digoksin, dabigatran, everolimus, sirolimus) z venetoklaksom se je treba izogibati.
English: Concomitant use of venetoclax with strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin) or moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided.
Slovenian: Sočasni uporabi venetoklaksa z močnimi induktorji CYP3A (npr. karbamazepinom, fenitoinom, rifampinom) ali zmernimi induktorji CYP3A (npr. bozentanom, efavirenzom, etravirinom, modafinilom, nafcilinom) se je treba izogibati.
English: No effects on fertility were observed in fertility and early embryonic development studies in male and female mice.
Slovenian: V študijah plodnosti in zgodnjega embrionalnega razvoja pri mišjih samcih in samicah niso opazili vplivov na plodnost.
English: Concomitant use of preparations containing St. John's wort (see sections 4.4 and 4.5).
Slovenian: Sočasna uporaba preparatov, ki vsebujejo šentjanževko (glejte poglavji 4.4 in 4.5).
English: If a patient misses a dose by more than 8 hours, the patient should not take the missed dose and should resume the usual dosing schedule the following day.
Slovenian: Če je bolnik izpustil odmerek in od časa, ko ga običajno vzame, mine več kot 8 ur, naj ne vzame izpuščenega odmerka in naj naslednji dan nadaljuje z običajno shemo odmerjanja.
English: Your doctor may need to reduce your dose of Venclyxto
Slovenian: Zdravnik vam bo morda moral znižati odmerek zdravila Venclyxto.
English: At baseline, 53% of patients had one or more nodes ≥5 cm, and 51% had ALC ≥25 x 109/l.
Slovenian: Izhodiščno je imelo 53 % bolnikov eno ali več bezgavk velikih ≥ 5 cm in 51 % je imelo ALC ≥ 25 x 109/l.
English: Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax (see section 4.5).
Slovenian: Med zdravljenjem z venetoklaksom se je treba izogibati izdelkom iz grenivke, seviljskim pomarančam in zvezdnemu sadežu (karamboli) (glejte poglavje 4.5).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING CARTON multipack (without blue box)
Slovenian: PODATKI NA PRIMARNI OVOJNINI ŠKATLA - večkratno pakiranje (brez modrega okenca)
English: Median time since diagnosis was 6.7 years (range: 0.3 to 29.5).
Slovenian: Mediana časa od diagnoze je bila 6,7 let (razpon: 0,3 do 29,5).
English: The median number of prior anti-CLL treatments was 2 (range: 1 to 10 treatments); 49.5% with a prior nucleoside analogue, 38% with prior rituximab, and 94% with a prior alkylator (including 33% with prior bendamustine).
Slovenian: Mediano število predhodnih zdravljenj KLL, ki so jih prejemali bolniki, je bilo 2 (razpon: od 1 do 10 zdravljenj), in sicer 49,5 % z nukleozidnim analogom, 38 % z rituksimabom in 94 % z alkilirajočim sredstvom (vključuje 33 % z bendamustinom).
English: In a dedicated hepatic impairment study, venetoclax Cmax and AUC in subjects with mild (Child-Pugh A; n=6) or moderate (Child-Pugh B; n=6) hepatic impairment were similar to subjects with normal hepatic function, after receiving a 50 mg single dose of venetoclax.
Slovenian: V namenski študiji okvare jeter, sta bila Cmax in AUC venetoklaksa pri preiskovancih z blago (ChildPugh A; n=6) ali zmerno (Child-Pugh B; n=6) okvaro jeter podobna kot pri preiskovancih z normalnim delovanjem jeter, po prejemu 50 mg enojnega odmerka venetoklaksa.
English: Concomitant use of venetoclax with moderate CYP3A inhibitors at initiation and during the dose-titration phase should be avoided.
Slovenian: Sočasni uporabi venetoklaksa z zmernimi zaviralci CYP3A na začetku zdravljenja in med fazo titracije odmerka se je treba izogibati.
English: - you are taking any of the medicines listed below when you start your treatment and while your dose is gradually being increased (usually over 5 weeks).
Slovenian: - na začetku vašega zdravljenja ali v obdobju postopnega povečevanja odmerka (običajno v
English: If you forget to take Venclyxto
Slovenian: Če ste pozabili vzeti zdravilo Venclyxto
English: The European Medicines Agency has waived the obligation to submit the results of studies with Venclyxto in all subsets of the paediatric population in CLL (see section 4.2 for information on paediatric use).
Slovenian: Venclyxto za vse podskupine pediatrične populacije pri KLL (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • muscle pain or uncomfortable joints
Slovenian: • bolečina v mišicah ali nelagodje v sklepih
English: Venetoclax as monotherapy for the treatment of patients with CLL who have failed a B-cell receptor pathway inhibitor - study M14-032
Slovenian: Venetoklaks kot monoterapija za zdravljenje bolnikov s KLL, pri katerih zdravljenje z zaviralcem receptorske poti celic B ni bilo uspešno - študija M14-032
English: Toxicities observed in animal studies with venetoclax included dose -dependent reductions in lymphocytes and red blood cell mass.
Slovenian: Med toksičnimi učinki, opaženimi v študijah venetoklaksa na živalih, sta bili od odmerka odvisno zmanjšanje števila limfocitov in zmanjšanje mase eritrocitov.
English: At baseline, 41% of patients had one or more nodes ≥5 cm and 31% had ALC ≥25 x 109/l.
Slovenian: Izhodiščno je imelo 41 % bolnikov eno ali več bezgavk velikih ≥ 5 cm in 31 % je imelo ALC ≥ 25 x 109/l.
English: All patients had CrCl ≥50 ml/min.
Slovenian: ≥ 50 ml/min.
English: The film-coated tablets are supplied in cartons containing either 5 or 7 tablets(in blisters of 1 tablet).
Slovenian: Filmsko obložene tablete so pakirane v škatlah, ki vsebujejo 5 ali 7 tablet (v pretisnih omotih po 1 tableto).
English: In a drug-drug interaction study, administration of a single 100 mg dose of venetoclax with 0.5 mg digoxin, a P-gp substrate, resulted in a 35% increase in digoxin Cmax and a 9% increase in digoxin AUC∞.
Slovenian: V študiji medsebojnega delovanja zdravil je dajanje enkratnega odmerka 100 mg venetoklaksa z 0,5 mg digoksina, substratom P-gp, povečalo Cmax digoksina za 35 % in AUC∞ digoksina za 9 %.
English: Of the 127 patients who were evaluated for efficacy from M14-032 study, 58% were 65 years or older.
Slovenian: Med 127 bolniki, pri katerih so v študiji M14-032 ocenjevali učinkovitost, je bilo 58 % starih
English: Therefore, women of childbearing potential must use highly effective contraceptive measures while taking venetoclax and for 30 days after stopping treatment.
Slovenian: Zato morajo ženske v rodni dobi med jemanjem venetoklaksa in še 30 dni po končanem zdravljenju uporabljati visoko učinkovito metodo kontracepcije.
English: Your doctor may need to stop certain medicines when you first start taking Venclyxto and during the first five weeks when your dose is gradually increased to the full standard dose.
Slovenian: Venclyxto in v prvih petih tednih, ko vam bo odmerek postopoma povečeval do celotnega standardnega odmerka.