FrancophonIA/ELRC3.0 huggingface dataset:
English: If the toxicity recurs, and for any subsequent occurrences, the dose reduction guidelines in Table 2 should be followed when resuming treatment with venetoclax following resolution.
Slovenian: Če se toksičnost znova pojavi ali v primeru kasnejših ponovitev, je treba ob ponovni uvedbi zdravljenja z venetoklaksom in po izginotju znakov toksičnosti upoštevati smernice za zmanjšanje odmerka v preglednici 2.
English: Do not breast-feed while you are taking this medicine.
Slovenian: Med jemanjem tega zdravila ne smete dojiti.
English: Co-administration of a 600 mg single dose of rifampin, a P-gp inhibitor, in 11 healthy subjects increased venetoclax Cmax by 106% and AUC∞ by 78%.
Slovenian: Sočasno dajanje 600 mg enkratnega odmerka rifampina, zaviralca P-gp, je pri 11 zdravih osebah povečalo Cmax venetoklaksa za 106 % in AUC∞ za 78 %.
English: In a drug-drug interaction study in three healthy volunteers, administration of a single dose of 400 mg venetoclax with 5 mg warfarin resulted in an 18% to 28% increase in Cmax and AUC∞ of R-warfarin and S-warfarin.
Slovenian: V študiji medsebojnega delovanja zdravil pri treh zdravih prostovoljcih, ki so jim dali enkratni odmerek 400 mg venetoklaksa s 5 mg varfarina, je prišlo do povečanja Cmax in AUC∞ R-varfarina ter S-varfarina za 18 % do 28 %.
English: At baseline, 46.6% of patients had one or more nodes ≥5 cm, and
Slovenian: Na začetku je imelo 46,6 % bolnikov eno ali več limfnih vozlov ≥ 5 cm, 67,6 % pa
English: P-gp and BCRP inhibitors
Slovenian: Zaviralci P-gp in BCRP
English: Dose modifications for use with CYP3A inhibitors
Slovenian: Prilagoditve odmerka zaradi uporabe z zaviralci CYP3A
English: What Venclyxto is and what it is used for What Venclyxto is
Slovenian: Kaj je zdravilo Venclyxto in za kaj ga uporabljamo Kaj je zdravilo Venclyxto
English: If a patient vomits following dosing, no additional dose should be taken that day.
Slovenian: Če bolnik po vzetem odmerku bruha, naj ta dan ne vzame dodatnega odmerka.
English: In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.
Slovenian: V študijah z monoterapijo sta bila najpogosteje poročana resna neželena učinka (≥ 2 %) pljučnica in vročinska nevtropenija.
English: Table 6: Efficacy results in patients with previously treated CLL with 17p deletion (study M13-982) Endpoint
Slovenian: Preglednica 6: Rezultati učinkovitosti pri bolnikih s predhodno zdravljeno KLL z delecijo 17p (študija M13-982)
English: Median prior lines of therapy was 1 (range: 1 to 5); and included alkylating agents (94%), anti-CD20 antibodies (77%), B-cell receptor pathway inhibitors (2%) and prior purine analogs (81%, including 55% FCR).
Slovenian: Mediana predhodnih vrst zdravljenja je bila 1 (razpon: od 1 do 5); in je vključevala alkilirajoče učinkovine (94 %), anti-CD20 protitelesa (77 %), zaviralce receptorske poti celic B (2 %) in purinske analoge (81 %, vključno s 55 %
English: What Venclyxto looks like and contents of the pack
Slovenian: Izgled zdravila Venclyxto in vsebina pakiranja
English: Venetoclax + rituximab N = 194
Slovenian: venetoklaks + rituksimab N = 194
English: The film-coated tablets are supplied in cartons containing either 10 or 14 tablets (in blisters of 2 tablets).
Slovenian: Filmsko obložene tablete so pakirane v škatlah, ki vsebujejo 10 ali 14 tablet (v pretisnih omotih po 2 tableti).
English: Blood chemistries should be reassessed prior to each subsequent dose increase during the titration phase.
Slovenian: Med fazo titracije je treba pred vsakim naslednjim povečanjem odmerka znova oceniti rezultate krvnih preiskav.
English: In a drug-drug interaction study in 12 healthy subjects, co-administration of 500 mg of azithromycin on the first day followed by 250 mg of azithromycin once daily for 4 days decreased venetoclax Cmax by 25% and AUC∞ by 35%.
Slovenian: V študiji medsebojnega delovanja zdravil pri dvanajstih zdravih osebah, ki so jim prvi dan sočasno dali 500 mg azitromicina, v naslednjih 4 dneh pa 250 mg azitromicina enkrat na dan, se je Cmax venetoklaksa zmanjšala za 25 % in AUC∞ za 35 %.
English: Based on a population pharmacokinetic analysis that included 219 subjects with mild renal impairment (CrCl ≥60 and <90 ml/min), 86 subjects with moderate renal impairment (CrCl ≥30 and <60 ml/min) and 217 subjects with normal renal function (CrCl ≥90 ml/min), venetoclax exposures in subjects with mild or moderate renal impairment are similar to those with normal renal function.
Slovenian: Opravljena je bila analiza populacijske farmakokinetike, ki je zajela 219 preiskovancev z blago okvaro ledvic (očistek kreatinina [CrCL] ≥ 60 in < 90 ml/min), 86 preiskovancev z zmerno okvaro ledvic (CrCL ≥ 30 in < 60 ml/min) in 217 preiskovancev z normalnim delovanjem ledvic (CrCL ≥ 90 ml/min).
English: Also inhibitors of P-gp or BCRP may increase venetoclax exposure (see section 4.5).
Slovenian: Tudi zaviralci P-gp ali BCRP lahko povečajo izpostavljenost venetoklaksu
English: aOne patient did not harbour the 17p deletion.
Slovenian: TTR, meseci, mediana (razpon) aEn bolnik ni imel delecije 17p.
English: Venetoclax was not genotoxic in bacterial mutagenicity assay, in vitro chromosome aberration assay and in vivo mouse micronucleus assay.
Slovenian: Venetoklaks ni bil genotoksičen v preizkusu mutagenosti pri bakterijah, preizkusu kromosomskih aberacij in vitro in mikrojedrnem preizkusu pri miših in vivo.
English: The median time since diagnosis was 6.8 years (range: 0.1 to 32 years; N=106).
Slovenian: Mediani čas od diagnoze je bil 6,8 let (razpon: od 0,1 do 32 let, N = 106).
English: No dose adjustment is needed for patients with mild or moderate renal impairment (CrCl ≥30 ml/min and <90 ml/min) (see section 5.2).
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic (CrCL ≥ 30 ml/min in < 90 ml/min) prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON Multipack (with blue box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - večkratno pakiranje (z modrim okencem)
English: Neutropenia is an identified risk with Venclyxto treatment.
Slovenian: Nevtropenija je ugotovljeno tveganje pri zdravljenju z venetoklaksom.
English: 27.5 (26.5, NR)
Slovenian: 27,5 (26,5, ND)
English: Efficacy results for the pre-specified primary analysis (data cut-off date 8 May 2017) were also assessed by an Independent Review Committee (IRC) demonstrating a statistically significant 81% reduction in the risk of progression or death for patients treated with venetoclax + rituximab (hazard ratio: 0.19 [95% CI: 0.13,
Slovenian: ki jih je ocenil tudi neodvisni odbor za pregled (Independent Review Committee - IRC), so pokazali statistično značilno 81 % zmanjšanje tveganja za napredovanje bolezni ali smrt za bolnike, zdravljene z venetoklaksom + rituksimabom (razmerje tveganja: 0,19 [95 % IZ: 0,13, 0,28], P <0,0001).
English: The primary efficacy endpoint was overall response rate (ORR) as assessed by an Independent Review Committee (IRC) using the IWCLL updated NCI-WG guidelines (2008).
Slovenian: Rate), kot ga je ocenil neodvisni odbor za pregled (IRC - Independent Review Committee) z uporabo smernic NCI-WG v posodobitvi IWCLL (2008).
English: Administration with a low-fat meal increased venetoclax exposure by approximately 3.4-fold and administration with a high-fat meal increased venetoclax exposure by 5.1- to 5.3-fold compared to fasting conditions.
Slovenian: V primerjavi z jemanjem na tešče je jemanje zdravila z malo mastnim obrokom povečalo izpostavljenost venetoklaksu za približno 3,4-krat, z zelo mastnim obrokom pa za 5,1- do 5,3-krat.
English: Of the 296 patients evaluated for safety from 3 open-label monotherapy trials, 57% were 65 years or older.
Slovenian: Med 296 bolniki, pri katerih so ocenjevali varnost v 3 odprtih študijah z monoterapijo, je bilo 57 %
English: Concomitant use of venetoclax with strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, ritonavir) at initiation and during the dose-titration phase is contraindicated due to increased risk for TLS (see section 4.3).
Slovenian: Sočasna uporaba venetoklaksa z močnimi zaviralci CYP3A (npr. itrakonazolom, ketokonazolom, posakonazolom, vorikonazolom, klaritromicinom, ritonavirjem) na začetku zdravljenja in med fazo titracije odmerka je kontraindicirana zaradi povečanega tveganja za TLS (glejte poglavje 4.3).
English: Co-administration of 600 mg once daily rifampin, a strong CYP3A inducer, for 13 days in 10 healthy subjects decreased venetoclax Cmax by 42% and AUC∞ by 71%.
Slovenian: Sočasno dajanje 600 mg rifampina, močnega induktorja CYP3A, enkrat na dan 13 dni, je pri 10 zdravih osebah zmanjšalo Cmax venetoklaksa za 42 % in AUC∞ za 71 %.
English: • low number of white blood cells with fever (febrile neutropenia)
Slovenian: • majhno število belih krvnih celic s povišano telesno temperaturo (febrilna nevtropenija) Krvni testi lahko pokažejo tudi:
English: Dose interruptions or reductions are recommended for patients with severe neutropenia (see section 4.2).
Slovenian: Pri bolnikih s hudo nevtropenijo je priporočljivo prekiniti odmerjanje ali zmanjšati odmerek (glejte poglavje 4.2).
English: Do not stop taking Venclyxto
Slovenian: Ne prenehajte jemati zdravilo Venclyxto
English: • higher level of creatinine
Slovenian: • povečano vrednost kreatinina • povečano vrednost sečnine
English: Patients with high tumour burden (e.g., any lymph node with a diameter ≥5 cm or high absolute lymphocyte count [ALC ≥25 x 109/l]) are at greater risk of TLS when initiating venetoclax.
Slovenian: Pri bolnikih z veliko tumorsko obremenitvijo (npr. bezgavka s premerom ≥ 5 cm ali veliko absolutno število limfocitov (ALC - Absolute Lymphocyte Count) [ALC ≥25 x 109/l]) je tveganje za TLS večje na začetku zdravljenja z venetoklaksom.
English: In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.
Slovenian: V študijah z monoterapijo z venetoklaksom je prišlo do prekinitve zdravljenja zaradi neželenih učinkov pri 11 % bolnikov.
English: cOf those with MRD assay results available in peripheral blood, 72.5% (121/167) in the venetoclax + rituximab arm and 20% (26/128) in the bendamustine + rituximab arm were found to be MRD negative.
Slovenian: cPri tistih z rezultati MRD testa, ki so bili na voljo v periferni krvi, je bilo ugotovljeno, da je MRD negativen pri 72,5 % (121/167) v skupini venetoklaks + rituksimab in pri 20 % (26/128) v skupini bendamustin + rituksimab.
English: Hazard ratio (95% CI) P-valuea
Slovenian: razmerje tveganj (95% IZ) P-vrednosta
English: The median age was 66 years (range: 28 to 85 years), 70% were male, and 92% were white.
Slovenian: Mediana starost je bila 66 let (razpon: od 28 do 85 let), 70 % je bilo moških in 92 % je bilo belcev.
English: - medicines for fungal infections - fluconazole, itraconazole, ketoconazole, posaconazole, or voriconazole - antibiotics to treat bacterial infections - ciprofloxacin, clarithromycin, erythromycin, nafcillin, or rifampicin - medicines to prevent seizures or to treat epilepsy - carbamazepine, phenytoin - medicines for HIV infection - efavirenz, etravirine, ritonavir - medicines to treat raised blood pressure or angina - diltiazem, verapamil - medicines to lower cholesterol levels in the blood - cholestyramine, colestipol, colesevelam - a medicine used to treat a lung condition called pulmonary arterial hypertension - bosentan - a medicine to treat sleep disorder (narcolepsy) known as modafinil - a herbal medicine known as St. John's wort
Slovenian: - zdravila za zdravljenje okužbe s HIV - efavirenz, etravirin, ritonavir - zdravila za zdravljenje zvišanega krvnega tlaka ali angine pektoris - diltiazem, verapamil - zdravila za znižanje ravni holesterola v krvi - holestiramin, kolestipol, kolesevelam
English: Number of events (%) Disease progression Death events
Slovenian: Število dogodkov (%) napredovanje bolezni smrtni dogodki mediana (meseci) (95% IZ)
English: No dose adjustment is needed during short-term use of azithromycin when administered concomitantly with venetoclax.
Slovenian: Pri kratkotrajni uporabi azitromicina sočasno z venetoklaksom prilagajanje odmerka ni potrebno.
English: If a patient experiences blood chemistry changes suggestive of TLS, the following day's venetoclax dose should be withheld.
Slovenian: Prilagoditve odmerka zaradi sindroma tumorske lize Če se pri bolniku pojavijo spremembe v rezultatih krvnih preiskav, ki kažejo na TLS, se naslednji dan ne sme dati odmerka venetoklaksa.
English: • the starting dose is 20 mg (two 10 mg tablets) once a day for 7 days.
Slovenian: • začetni odmerek je 20 mg (dve 10 mg tableti) enkrat na dan, 7 dni
English: potassium >6 mmol/l, uric acid >476 µmol/l, calcium <1.75 mmol/l, or phosphorus >1.5 mmol/l; or were reported as TLS events) and occurred in patients who had a lymph node(s) ≥5 cm or ALC ≥25 x 109/l.
Slovenian: Vsi primeri TLS so bili laboratorijski (laboratorijske nepravilnosti, ki so ustrezale ≥ 2 od naslednjih kriterijev in so se pojavile v 24 urah: kalij > 6 mmol/l, sečna kislina > 476 µmol/l, kalcij < 1,75 mmol/l ali fosfor > 1,5 mmol/l; ali so bili poročani kot primeri TLS) in so se zgodili pri bolnikih, ki so imeli bezgavk(o)e ≥ 5 cm ali ALC ≥ 25 x 109/l.
English: dOf those with MRD assay results available in bone marrow, 76.9% (30/39) in the venetoclax + rituximab arm and 6.7% (2/30) in the bendamustine + rituximab arm were found to be MRD negative.
Slovenian: dPri tistih z rezultati MRD testa, ki so bili na voljo v kostnem mozgu, je bilo ugotovljeno, da je MRD negativen pri 76,9 % (30/39) v skupini venetoklaks + rituksimab in pri 6,7 % (2/30) v skupini bendamustin + rituksimab.
English: Treatment with Venclyxto should be withheld for any grade 3 or 4 non-haematological toxicities, grade 3 or 4 neutropenia with infection or fever, or grade 4 haematological toxicities, except lymphopenia.
Slovenian: 4. stopnje, nevtropenije 3. ali 4. stopnje z okužbo ali zvišano telesno temperaturo ali pa hematološke toksičnosti 4. stopnje, z izjemo limfopenije.
English: Venetoclax is a P-gp, BCRP and OATP1B1 inhibitor in vitro.
Slovenian: Venetoklaks je zaviralec P-gp, BCRP in OATP1B1 in vitro.
English: With venetoclax + rituximab treatment, febrile neutropenia was reported in 4% of patients, grade ≥3 infections in 18%, and serious infections in 21% of patients.
Slovenian: rituksimabom so poročali o febrilni nevtropeniji pri 4 % bolnikov, o okužbah stopnje ≥ 3 pri 18 %
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (5 day pack)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (pakiranje za 5 dni)
English: The median age was 67 years (range: 37 to 85 years); 65% were male, and 97% were white.
Slovenian: Mediana starost je bila 67 let (razpon: od 37 do 85 let); 65 % je bilo moških in 97 % je bilo belcev.
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (7 day pack)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (pakiranje za 7 dni)
English: Anti-hyperuricaemic agents should be administered 2 to 3 days prior to starting treatment with venetoclax in patients with high uric acid levels or at risk of TLS and may be continued through the titration phase.
Slovenian: Pri bolnikih z velikimi vrednostmi sečne kisline ali pri tistih s tveganjem za TLS je treba antihiperurikemike dati 2 do 3 dni pred začetkom zdravljenja z venetokslaksom in se z njimi lahko nadaljuje skozi vso fazo titracije.
English: Concomitant use of venetoclax with strong or moderate CYP3A inhibitors increases venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase and for other toxicities (see section 4.5).
Slovenian: Sočasna uporaba venetoklaksa z močnimi ali zmernimi zaviralci CYP3A poveča izpostavljenost venetoklaksu in lahko poveča tveganje za TLS na začetku zdravljenja in med fazo titracije odmerka ter za druge toksičnosti (glejte poglavje 4.5).
English: Venetoclax is a weak inhibitor of CYP2C8, CYP2C9 and UGT1A1 in vitro, but it is not predicted to cause clinically relevant inhibition.
Slovenian: CYP2C9 in UGT1A1, vendar predvidoma ne povzroči klinično pomembnega zavrtja.
English: Venetoclax daily dose
Slovenian: Dnevni odmerek venetoklaksa
English: Restart dose (mga)
Slovenian: Odmerek ob ponovni uvedbi zdravljenja (mga)
English: • If you are not sure talk to your doctor, pharmacist or nurse.
Slovenian: • Če niste prepričani, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Based on a population pharmacokinetic analysis that included 74 subjects with mild hepatic impairment, 7 subjects with moderate hepatic impairment and 442 subjects with normal hepatic function, venetoclax exposures are similar in subjects with mild and moderate hepatic impairment and normal hepatic function.
Slovenian: Opravljena je bila analiza populacijske farmakokinetike, ki je zajela 74 preiskovancev z blago okvaro jeter, 7 preiskovancev z zmerno okvaro jeter in 442 preiskovancev z normalnim delovanjem jeter.
English: The venetoclax dose that was used prior to initiating the CYP3A inhibitor should be resumed 2 to 3 days after discontinuation of the inhibitor (see section 4.2).
Slovenian: Odmerek venetoklaksa, ki se je uporabljal pred začetkom zdravljenja z zaviralcem CYP3A, je treba znova uvesti 2 do 3 dni po prenehanju zdravljenja z zaviralcem (glejte poglavje 4.2).
English: A larger dose reduction may occur at the discretion of the physician.
Slovenian: Zdravnik lahko zaradi previdnosti dodatno zmanjša odmerek.
English: • In the tablet core: copovidone (K 28), polysorbate 80 (E433), colloidal anhydrous silica (E551),
Slovenian: • Jedro tablete: kopovidon (K 28), polisorbat 80 (E433), brezvodni koloidni silicijev dioksid
English: Tumour lysis syndrome Hyperkalaemia Hyperphosphataemia Hypocalcaemia
Slovenian: Presnovne in prehranske motnje zelo pogosti hiperkaliemija hiperfosfatemija hipokalciemija pogosti sindrom tumorske lize hiperurikemija sindrom tumorske lize hiperkaliemija hiperfosfatemija hipokalciemija občasni hiperurikemija
English: OS, % (95% CI)
Slovenian: OS, % (95% IZ)
English: Patients randomised to BR received bendamustine at 70 mg/m2 on Days 1 and 2
Slovenian: Bolniki, randomizirani na BR, so prejemali bendamustin 70 mg/m2 6 ciklusov na 1. in 2. dan in rituksimab, kot je opisano zgoraj.
English: Pale yellow, oblong biconvex shaped tablet 17.2 mm long, 9.5 mm wide debossed with V on one side and 100 on the other.
Slovenian: Svetlo rumene, podolgovate, bikonveksne tablete, dolge 17,2 mm in široke 9,5 mm z oznako V na eni in 100 na drugi strani.
English: • 5 tablets (5 blisters each with 1 tablet)
Slovenian: • 5 tablet (5 pretisnih omotov s po 1 tableto)
English: Median age was 65 years (range: 22 to 85); 74% were male, and 97% were white.
Slovenian: Mediana starosti je bila 65 let (razpon od 22 do 85 let); 74 % jih je bilo moških in 97 % jih je bilo belcev.
English: Forest plot of Investigator-Assessed PFS in Subgroups from MURANO
Slovenian: Drevesni diagram za vrednosti preživetja brez napredovanja bolezni ocenjene s strani raziskovalca pri podskupinah v študiji MURANO
English: • dark or cloudy urine
Slovenian: • neenakomeren srčni utrip • temen ali moten urin
English: Concomitant use of venetoclax with strong CYP3A inhibitors at initiation and during the dose-titration phase is contraindicated (see sections 4.3, 4.4, and 4.5).
Slovenian: Sočasna uporaba venetoklaksa z močnimi zaviralci CYP3A na začetku zdravljenja in med fazo titracije odmerka je kontraindicirana (glejte poglavja 4.3, 4.4 in 4.5).
English: Hazard ratio
Slovenian: Razmerje tveganj
English: Breast-feeding should be discontinued during treatment with Venclyxto.
Slovenian: Med zdravljenjem z zdravilom Venclyxto je treba dojenje prekiniti.
English: anydrous calcium hydrogen phosphate (E341 (ii)), sodium stearyl fumarate.
Slovenian: (E551), brezvodni kalcijev hidrogenfosfat, brezvodni (E341 (ii)), natrijev stearilfumarat.
English: For patients who have had a dosing interruption lasting more than 1 week during the first 5 weeks of dose titration or more than 2 weeks after completing the dose-titration phase, TLS risk should be reassessed to determine if restarting at a reduced dose is necessary (e.g., all or some levels of the dose titration; see Table
Slovenian: 1 teden oziroma več kot 2 tedna po zaključku faze titracije odmerka, je treba znova oceniti tveganje za
English: DOR, months, median (95% CI)
Slovenian: DOR, meseci, mediana (95 % IZ)
English: 28 film-coated tablets Component of a multipack, can't be sold separately.
Slovenian: Del večkratnega pakiranja, ni na voljo samostojno.
English: Patients with high tumour burden (e.g., any lymph node with a diameter ≥5 cm or high ALC ≥25 x 109/l) are at greater risk of TLS when initiating venetoclax.
Slovenian: Pri bolnikih z veliko tumorsko obremenitvijo (npr. bezgavka s premerom ≥ 5 cm ali veliko absolutno število limfocitov [ALC ≥25 x 109/l]) je tveganje za TLS večje na začetku zdravljenja z venetoklaksom.
English: In vitro studies indicated that venetoclax is not an inhibitor or inducer of CYP1A2, CYP2B6, CYP2C19, CYP2D6 or CYP3A4 at clinically relevant concentrations.
Slovenian: CYP1A2, CYP2B6, CYP2C19, CYP2D6 ali CYP3A4.
English: It is important that you tell your doctor, pharmacist, or nurse about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Slovenian: Pomembno je, da zdravniku, farmacevtu ali medicinski sestri poveste o vseh zdravilih, ki jih jemljete,
English: All events were laboratory TLS
Slovenian: Vsi bolniki so imeli CrCL
English: If a moderate CYP3A inhibitor must be used, the initiation dose of venetoclax and the doses for the titration phase (see section 4.2) should be reduced by at least 50%.
Slovenian: nujna, je treba začetni odmerek venetoklaksa in odmerke v fazi titracije (glejte poglavje 4.2) zmanjšati za vsaj 50 %.
English: There were no overall differences in safety or efficacy observed between older and younger patients in the combination study with venetoclax + rituximab and the monotherapy studies.
Slovenian: Med starejšimi in mlajšimi bolniki v študiji s kombinacijo venetoklaks + rituksimab in v študijah z monoterapijo v celoti niso ugotovili razlik glede varnosti in učinkovitosti.
English: ORR, % (95% CI)
Slovenian: ORR, % (95 % IZ)
English: PFS, months, median (95% CI)
Slovenian: PFS, meseci, mediana (95% IZ)
English: Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets
Slovenian: Venclyxto 10 mg filmsko obložene tablete Venclyxto 50 mg filmsko obložene tablete Venclyxto 100 mg filmsko obložene tablete
English: Table 7: Efficacy results as assessed by investigator in patients who have failed a B-cell receptor pathway inhibitor (study M14-032)
Slovenian: Preglednica 7: Rezultati učinkovitosti po oceni raziskovalca pri bolnikih, pri katerih zdravljenje z zaviralcem receptorske poti celic B ni bilo uspešno (študija M14-032) Skupina A (neuspeh z ibrutinibom) (N = 91)
English: Women of childbearing potential/Contraception in females Women should avoid becoming pregnant while taking Venclyxto and for at least 30 days after ending treatment.
Slovenian: Ženske se morajo izogniti zanositvi med jemanjem zdravila Venclyxto in še vsaj 30 dni po končanem zdravljenju.
English: Co-administration of venetoclax with other strong CYP3A4 inhibitors is predicted to increase venetoclax AUC by on average 5.8- to 7.8-fold.
Slovenian: predvideno AUC venetoklaksa poveča v povprečju za 5,8- do 7,8-krat.
English: The venetoclax dose that was used prior to initiating the CYP3A inhibitor should be resumed 2 to 3 days after discontinuation of the inhibitor (see sections 4.4 and 4.5).
Slovenian: Odmerek venetoklaksa, ki se je uporabljal pred začetkom sočasnega zdravljenja z zaviralcem CYP3A, je treba znova uvesti 2 do 3 dni po prekinitvi zdravljenja z zaviralcem (glejte poglavji 4.4 in 4.5).
English: • 7 tablets (7 blisters each with 1 tablet)
Slovenian: • 7 tablet (7 pretisnih omotov s po 1 tableto)