FrancophonIA/ELRC3.0 huggingface dataset:
English: Venetoclax should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS (see section 4.4).
Croatian: Venetoklaks treba primijeniti u bolesnika s teškim oštećenjem bubrežne funkcije samo ako korist premašuje rizik i tada bolesnike treba pažljivo nadzirati zbog mogućih znakova toksičnosti uslijed povećanog rizika od TLS-a (vidjeti dio 4.4).
English: Laboratory assessments
Croatian: Određivanje laboratorijskih vrijednosti
English: In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.
Croatian: U ispitivanjima monoterapije, najčešće prijavljene ozbiljne nuspojave (≥ 2%) bile su pneumonija i febrilna neutropenija.
English: The next venetoclax dose should not be administered until the 24-hour blood chemistry results have been evaluated.
Croatian: Sljedeća doza venetoklaksa ne smije se primijeniti dok se ne ocijene nalazi biokemijskih parametara krvi 24 sata nakon prethodne doze.
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).
Croatian: Farmakokinetika venetoklaksa nije se ispitivala u ispitanika s teškim oštećenjem bubrežne funkcije (CrCl < 30 ml/min) ni bolesnika na dijalizi (vidjeti dio 4.2).
English: The median time on treatment for 158 patients was 17 months (range: 0 to 34 months).
Croatian: Medijan vremena provedenog u liječenju za 158 bolesnika iznosio je 17 mjeseci (raspon: 0 do 34 mjeseci).
English: • 112 (4 x 28) tablets (4 cartons of 7 blisters each with 4 tablets).
Croatian: • 112 (4 x 28) tableta (4 kutije sa 7 blistera, svaki s 4 tablete).
English: Treatment with venetoclax should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Croatian: 4.2 Doziranje i način primjene Liječenje venetoklaksom treba započeti i nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: • lower level of calcium
Croatian: • snižene vrijednosti kalcija
English: After 77/389 patients were enrolled in the study, the protocol was amended to incorporate the current TLS prophylaxis and monitoring measures described in Posology (see section 4.2).
Croatian: Nakon što je u ispitivanje uključeno 77/389 bolesnika, plan ispitivanja izmijenjen je radi uvrštavanja trenutno važećih mjera za profilaksu i kontrolu TLS-a opisanih u dijelu 'Doziranje' (vidjeti dio 4.2).
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).
Croatian: U ispitivanjima faze 2 i faze 1 352 bolesnika s prethodno liječenim KLL-om primalo je monoterapiju venetoklaksom, uključujući 212 bolesnika s delecijom 17p i 146 bolesnika koji nisu odgovorili na liječenje inhibitorom signalnih puteva B-staničnih receptora (vidjeti dio 5.1).
English: Venetoclax is a substrate for P-gp and BCRP.
Croatian: Venetoklaks je supstrat P-gp-a i BCRP-a.
English: Carcinogenicity studies have not been conducted with venetoclax.
Croatian: Nisu provedena ispitivanja kancerogenosti venetoklaksa.
English: Safety in patients with severe renal impairment (CrCl <30 ml/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined.
Croatian: (CrCl < 30 ml/min) ili onih na dijalizi nije ustanovljena, te preporučena doza za te bolesnike nije utvrđena.
English: - you are taking a herbal medicine called St. John's wort, used for depression.
Croatian: - ako uzimate biljni lijek koji se zove gospina trava, a koristi se za liječenje depresije.
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.
Croatian: Dvadeset i pet posto (32/127) bolesnika imalo je negativan nalaz na MRD u perifernoj krvi, uključujući 8 bolesnika koji su imali negativan nalaz na MRD i u koštanoj srži.
English: What you need to know before you take Venclyxto 3.
Croatian: Što morate znati prije nego počnete uzimati Venclyxto
English: The risk may decrease as tumour burden decreases with venetoclax treatment (see section 4.4).
Croatian: Rizik se može smanjiti kako se smanjuje opterećenje tumorskom masom uslijed liječenja venetoklaksom (vidjeti dio 4.4).
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.
Croatian: Ako Vaš liječnik smatra da kod Vas postoji rizik od TLS-a, možda ćete se morati liječiti u bolnici kako bi se po potrebi omogućila primjena tekućina u venu, češće krvne pretrage i praćenje zbog mogućih nuspojava.
English: The following serious side effects may happen with this medicine:
Croatian: Kod primjene ovog lijeka mogu se javiti sljedeće ozbiljne nuspojave:
English: Median follow-up time for primary analysis was 23.8 months (range: 0.0 to 37.4 months).
Croatian: Medijan trajanja praćenja za primarnu analizu iznosio je 23,8 mjeseci (raspon: 0,0 do 37,4 mjeseca).
English: Venetoclax is a weak inhibitor of CYP2C8, CYP2C9 and UGT1A1 in vitro, but it is not predicted to cause clinically relevant inhibition.
Croatian: Venetoklaks je slab inhibitor CYP2C8, CYP2C9 i UGT1A1 in vitro, ali se ne predviđa da bi mogao uzrokovati klinički značajnu inhibiciju.
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.
Croatian: Ako se toksičnost povrati i kod svake sljedeće pojave, pri ponovnom uvođenju liječenja venetoklaksom nakon njezina povlačenja treba se pridržavati smjernica za smanjenje doze navedenih u Tablici 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).
Croatian: Kromosomske aberacije bile su delecija 11q (34%, 43/127), delecija 17p (40%, 50/126), mutacija gena TP53 (38%, 26/68) i nemutirani gen IgVH (78%, 72/92).
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.
Croatian: U ispitivanjima embriofetalnog razvoja u miševa, venetoklaks je bio povezan s povećanim brojem postimplantacijskih gubitaka i smanjenjem tjelesne težine ploda pri razinama izloženosti 1,1 x izloženost [AUC] koja se postiže u ljudi kod primjene preporučene doze.
English: In vitro studies demonstrated that venetoclax is predominantly metabolised by cytochrome P450 CYP3A4.
Croatian: Ispitivanja in vitro pokazala su da se venetoklaks pretežno metabolizira putem enzima citokroma P450 CYP3A4.
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.
Croatian: Primijećena je toksičnost za testise (gubitak zametnih stanica) u ispitivanjima opće toksičnosti u pasa pri razinama izloženosti od 0,5 do 18 x izloženost [AUC] koja se postiže u ljudi kod primjene preporučene doze.
English: Concomitant use of venetoclax with strong or moderate CYP3A4 inducers should be avoided (see sections 4.3 and 4.5).
Croatian: Treba izbjegavati istodobnu primjenu venetoklaksa i snažnih ili umjerenih induktora CYP3A4 (vidjeti dijelove 4.3 i 4.5).
English: If a narrow therapeutic index P-gp or BCRP substrate must be used, it should be used with caution.
Croatian: Ako se mora primijeniti supstrat P-gp-a ili BCRP-a uskog terapijskog indeksa, treba ga primjenjivati uz oprez.
English: Do not breast-feed while you are taking this medicine.
Croatian: Ne smijete dojiti dok uzimate ovaj lijek.
English: If a patient experiences blood chemistry changes suggestive of TLS, the following day's venetoclax dose should be withheld.
Croatian: Ako u bolesnika nastupe promjene u biokemijskim parametrima krvi koji ukazuju na TLS, sljedeći dan dozu venetoklaksa ne treba primijeniti.
English: o When you are receiving Venclyxto therapy in combination with rituximab, you will receive the 400 mg daily dose for 24 months.
Croatian: o Ako se budete liječili lijekom Venclyxto u kombinaciji s rituksimabom, primat ćete dozu od 400 mg na dan tijekom 24 mjeseca.
English: Breast-feeding should be discontinued during treatment with Venclyxto.
Croatian: Dojenje treba prekinuti tijekom liječenja lijekom Venclyxto.
English: Your doctor may change your dose of Venclyxto.
Croatian: Liječnik će Vam možda promijeniti dozu lijeka Venclyxto.
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.
Croatian: Kod peroralne primjene supstrata P-gp-a ili BCRP-a osjetljivog na inhibiciju u probavnom sustavu (npr. dabigatraneksetilata), razmak između njegove primjene i primjene venetoklaksa treba biti što veći kako bi se minimizirala moguća interakcija.
English: The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg as shown in Table 1.
Croatian: Doza se mora postupno povećavati tijekom razdoblja od 5 tjedana do dnevne doze od 400 mg na način prikazan u Tablici 1. Tablica 1: Raspored povećavanja doze
English: At the time of evaluation, median duration of treatment with venetoclax was 14.3 months (range: 0.1 to 31.4 months).
Croatian: Medijan trajanja liječenja venetoklaksom u trenutku ocjene iznosio je 14,3 mjeseca (raspon: 0,1 do 31,4 mjeseca).
English: More intensive measures should be employed as overall risk increases.
Croatian: treba provoditi intenzivnije mjere.
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.
Croatian: Nakon primjene: U bolesnika u kojih postoji rizik od TLS-a, biokemijske parametre krvi treba odrediti 6 do 8 sati i 24 sata nakon primjene prve doze venetoklaksa.
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.
Croatian: Blago oštećenje jetrene funkcije definiralo se kao normalna vrijednost ukupnog bilirubina i vrijednost aspartat transaminaze (AST) > gornje granice normale (GGN) ili ukupni bilirubin > 1,0 - 1,5 x GGN, umjereno oštećenje jetrene funkcije kao ukupni bilirubin > 1,5 - 3 x GGN, a teško oštećenje jetrene funkcije kao ukupni bilirubin > 3,0 x GGN.
English: Your doctor may need to reduce your dose of Venclyxto
Croatian: Liječnik će možda morati smanjiti dozu lijeka Venclyxto
English: Patients in the Venclyxto + rituximab arm completed the Venclyxto 5-week dose-titration schedule and then received 400 mg once daily for 24 months from Cycle 1 Day 1 of rituximab in the absence of disease progression or unacceptable toxicity.
Croatian: Bolesnici u skupini koja je primala Venclyxto + rituksimab dovršili su titraciju doze prema 5-tjednom rasporedu i zatim primali dozu od 400 mg jedanput na dan tijekom 24 mjeseca, računajući od 1. dana 1. ciklusa primjene rituksimaba, ako nije došlo do progresije bolesti ili pojave neprihvatljive toksičnosti.
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.
Croatian: Rituksimab je uveden nakon 5-tjednog razdoblja titracije, u dozi od 375 mg/m2 za 1. ciklus odnosno 500 mg/m2 za 2. - 6. ciklus.
English: Of the 296 patients evaluated for safety from 3 open-label monotherapy trials, 57% were 65 years or older.
Croatian: Među 296 bolesnika kod kojih se ocjenjivala sigurnost u 3 otvorena ispitivanja monoterapije, njih 57% bilo je u dobi od 65 ili više godina.
English: Therefore, women of childbearing potential must use highly effective contraceptive measures while taking venetoclax and for 30 days after stopping treatment.
Croatian: Stoga žene reproduktivne dobi moraju koristiti visoko učinkovite mjere kontracepcije tijekom uzimanja venetoklaksa i još 30 dana nakon završetka liječenja.
English: The observed PFS benefit of venetoclax + rituximab compared with bendamustine + rituximab was consistently observed across all subgroups of patients evaluated, including age (< 65, ≥ 65 years and < 75, ≥ 75 years), prior lines of therapy (1, >1), bulky disease (< 5 cm, ≥ 5 cm), 17p deletion, 11q deletion, TP53 mutation, IgVH mutation, and refractory versus relapse to most recent therapy (Figure 3).
Croatian: + rituksimab dosljedno je bio primjetan u svim ocijenjenim podskupinama bolesnika, uključujući podskupine prema dobi (< 65, ≥ 65 godina te < 75, ≥ 75 godina), prethodnim linijama liječenja (1, > 1), opterećenju tumorskom masom (< 5 cm, ≥ 5 cm), deleciji 17p, deleciji 11q, mutaciji gena TP53, mutaciji gena IgVH te bolesti refraktornoj na posljednju terapiju naspram relapsa bolesti tijekom posljednje terapije (Slika 3).
English: If you forget to take Venclyxto
Croatian: Ako ste zaboravili uzeti Venclyxto
English: Based on testicular toxicity in dogs at clinically relevant exposures, male fertility may be compromised by treatment with venetoclax (see section 5.3).
Croatian: Sudeći prema toksičnosti za testise u pasa pri klinički relevantnim razinama izloženosti, liječenje venetoklaksom može smanjiti plodnost muškaraca (vidjeti dio 5.3).
English: Efficacy results are shown in Table 6.
Croatian: Rezultati za djelotvornost prikazani su u Tablici
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.
Croatian: Treba izbjegavati istodobnu primjenu venetoklaksa sa snažnim induktorima CYP3A (npr. karbamazepinom, fenitoinom, rifampinom) ili umjerenim induktorima CYP3A (npr. bosentanom, efavirenzom, etravirinom, modafinilom, nafcilinom).
English: Of the 127 patients who were evaluated for efficacy from M14-032 study, 58% were 65 years or older.
Croatian: Među 127 bolesnika kod kojih se ocjenjivala djelotvornost u ispitivanju M14-032, njih 58% bilo je u dobi od 65 ili više godina.
English: Alternative treatments with less CYP3A induction should be considered.
Croatian: Treba razmotriti druge mogućnosti liječenja koje manje induciraju CYP3A.
English: • feeling or being sick (nausea or vomiting)
Croatian: • vrućicu ili zimicu • mučninu ili povraćanje
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.
Croatian: Ako bolesnik propusti uzeti dozu, a od vremena kada je obično uzima je prošlo više od 8 sati, ne smije uzeti propuštenu dozu, već treba nastaviti s primjenom sljedeći dan prema uobičajenom rasporedu.
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
Croatian: Djelotvornost i sigurnost venetoklaksa u bolesnika s KLL-om koji su prethodno bili liječeni ibrutinibom ili idelalisibom, ali nisu odgovorili na terapiju tim lijekovima, ocjenjivale su se u otvorenom, multicentričnom, nerandomiziranom ispitivanju faze 2 (M14-032).
English: Do not stop taking Venclyxto
Croatian: Nemojte prestati uzimati Venclyxto
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.
Croatian: Medijan broja prethodnih onkoloških terapija bio je 4 (raspon: 1 do 15) u bolesnika liječenih ibrutinibom te 3
English: You should continue to drink at least 1.5 to 2 litres of water on the day you start Venclyxto.
Croatian: 1,5 - 2 litre vode na dan kada počnete uzimati Venclyxto.
English: In rabbits, venetoclax produced maternal toxicity, but no foetal toxicity at exposures of 0.1 times the human AUC exposure at the recommended dose.
Croatian: U kunića je venetoklaks uzrokovao toksičnost za majku, ali ne i toksičnost za fetus pri razinama izloženosti 0,1 x izloženost[AUC] koja se postiže u ljudi kod primjene preporučene doze.
English: What Venclyxto is and what it is used for What Venclyxto is
Croatian: Što je Venclyxto i za što se koristi Što je Venclyxto
English: • If you are not sure talk to your doctor, pharmacist or nurse.
Croatian: • Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: Substrates of P-gp, BCRP, and OATP1B1
Croatian: Supstrati P-gp-a, BCRP-a i prijenosnika OATP1B1
English: Venclyxto monotherapy is indicated for the treatment of CLL:
Croatian: Venclyxto je indiciran kao monoterapija za liječenje KLL-a:
English: Venclyxto tablets are provided in blisters which are packed in cartons as follows:
Croatian: Venclyxto tablete dolaze u blisterima zapakiranima u kutije sa:
English: • itraconazole ketoconazole, posaconazole, or voriconazole for fungal infections
Croatian: • itrakonazolom, ketokonazolom, posakonazolom ili vorikonazolom, za liječenje gljivičnih infekcija
English: The most frequently reported serious adverse reactions (≥2%) in patients receiving venetoclax in combination with rituximab were pneumonia, febrile neutropenia, and TLS.
Croatian: Najčešće prijavljene ozbiljne nuspojave (≥ 2%) u bolesnika koji su primali venetoklaks u kombinaciji s rituksimabom bile su pneumonija, febrilna neutropenija i TLS.
English: If a moderate CYP3A inhibitor must be used, the initiation and titration doses of venetoclax should be reduced by at least 50%.
Croatian: Ako se mora primijeniti umjeren inhibitor CYP3A, početnu dozu i doze venetoklaksa tijekom titracije treba smanjiti za najmanje 50%.
English: Forest plot of Investigator-Assessed PFS in Subgroups from MURANO
Croatian: Slika 3. Grafikon raspona pouzdanosti (engl. forest plot) za PFS prema ocjeni ispitivača u podskupinama iz ispitivanja MURANO
English: The median time since diagnosis was 8.3 years (range: 0.3 to 18.5 years; N=96).
Croatian: Medijan vremena od dijagnoze iznosio je 8,3 godine (raspon: 0,3 do 18,5 godina; N=96).
English: Table 4: Investigator-assessed progression-free survival in patients with previously treated CLL in MURANO
Croatian: Tablica 4: Preživljenje bez progresije bolesti prema ocjeni ispitivača među bolesnicima s prethodno liječenim KLL-om u ispitivanju MURANO
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).
Croatian: Istodobna primjena venetoklaksa sa snažnim inhibitorima CYP3A (npr. itrakonazolom, ketokonazolom, posakonazolom, vorikonazolom, klaritromicinom, ritonavirom) pri uvođenju liječenja i tijekom faze titracije doze kontraindicirana je zbog povećanog rizika od TLS-a (vidjeti dio 4.3).
English: Neutropenia is an identified risk with Venclyxto treatment.
Croatian: Neutropenija je poznat rizik liječenja lijekom Venclyxto.
English: The primary efficacy endpoint was ORR according to IWCLL updated NCI-WG guidelines.
Croatian: Primarna mjera ishoda za djelotvornost bio je ORR prema NCI-WG smjernicama koje je ažurirao IWCLL.
English: Of the 107 patients who were evaluated for efficacy from M13-982 study, 57% were 65 years or older.
Croatian: Među 107 bolesnika kod kojih se ocjenjivala djelotvornost u ispitivanju M13-982, njih 57% bilo je u dobi od 65 ili više godina.
English: Patients should be monitored more closely for signs of toxicities (see sections 4.4 and 4.5).
Croatian: Bolesnike treba pažljivije nadzirati zbog mogućih znakova toksičnosti (vidjeti dijelove 4.4 i 4.5).
English: Median age was 65 years (range: 22 to 85); 74% were male, and 97% were white.
Croatian: Medijan dobi iznosio je 65 godina (raspon: 22 do 85); 74% bili su muškarci, a 97% bijelci.
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.
Croatian: Ako kod Vas postoji rizik od TLS-a, možda ćete se morati liječiti u bolnici kako bi se po potrebi omogućila primjena tekućina u venu, češće provođenje krvnih pretraga i praćenje zbog mogućih nuspojava.
English: Additional efficacy results in MURANO Investigator assessed
Croatian: Tablica 5. Dodatni rezultati za djelotvornost u ispitivanju MURANO
English: Your doctor may also give you medicines to help prevent the build up of uric acid in your body before you start treatment with Venclyxto.
Croatian: Liječnik će Vam prije početka liječenja lijekom Venclyxto možda dati i lijekove koji će pomoći spriječiti nakupljanje mokraćne kiseline u tijelu.
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).
Croatian: U ispitanika s teškim (Child-Pugh C; n=5) oštećenjem jetrene funkcije, srednja vrijednost Cmax za venetoklaks bila je slična onoj u ispitanika s normalnom jetrenom funkcijom, ali je vrijednost AUCinf za venetoklaks bila u prosjeku 2,7 puta veća (raspon: od bez promjene do 5 puta veća) u odnosu na vrijednost AUCinf za venetoklaks u ispitanika s normalnom jetrenom funkcijom (vidjeti dio 4.2).
English: Agents that may have their plasma concentrations altered by venetoclax
Croatian: Lijekovi čija se plazmatska koncentracija može promijeniti uslijed djelovanja venetoklaksa
English: Preparations containing St. John's wort are contraindicated during treatment with venetoclax, as efficacy may be reduced (see section 4.3).
Croatian: Primjena pripravaka koji sadrže gospinu travu kontraindicirana je tijekom liječenja venetoklaksom jer može smanjiti njegovu djelotvornost (vidjeti dio 4.3).
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.
Croatian: U ispitivanju oštećenja jetrene funkcije, vrijednosti Cmax i AUC za venetoklaks u ispitanika s blagim (Child-Pugh A; n=6) ili umjerenim (Child-Pugh B; n=6) oštećenjem jetrene funkcije bile su slične onim u ispitanika s normalnom jetrenom funkcijom, nakon primanja jedne doze venetoklaksa od 50 mg.
English: Agents that may alter venetoclax plasma concentrations
Croatian: Lijekovi koji mogu promijeniti plazmatske koncentracije venetoklaksa
English: If a patient vomits following dosing, no additional dose should be taken that day.
Croatian: Ako bolesnik povrati nakon uzimanja doze, ne smije uzeti dodatnu dozu taj dan.
English: Venclyxto film-coated tablets are for oral use.
Croatian: Venclyxto filmom obložene tablete namijenjene su za peroralnu primjenu.
English: 25 (19.6, NR)
Croatian: 25 (19,6; NP)
English: Table 6: Efficacy results in patients with previously treated CLL with 17p deletion (study M13-982) Endpoint
Croatian: Tablica 6: Rezultati za djelotvornost u bolesnika s prethodno liječenim KLL-om i delecijom 17p (ispitivanje M13-982)
English: In non-clinical studies, venetoclax has demonstrated cytotoxic activity in tumour cells that overexpress BCL-2.
Croatian: U nekliničkim je ispitivanjima venetoklaks pokazao citotoksičnu aktivnost u tumorskim stanicama koje prekomjerno eksprimiraju