natgillin/translations-raw huggingface dataset:
anydrous calcium hydrogen phosphate (E341 (ii)), sodium stearyl fumarate. 
(E551), bezvodni kalcijev hidrogenfosfat (E341 (ii)), natrijev stearilfumarat.
Under low-fat meal conditions, venetoclax mean (± standard deviation) steady state Cmax was 2.1 ± 1.1 μg/ml and AUC24 was 32.8 ± 16.9 μg•h/ml at the 400 mg once daily dose. 
srednja vrijednost (± standardno odstupanje) Cmax i AUC24 venetoklaksa u stanju dinamičke ravnoteže uz dozu od 400 mg jedanput na dan iznosila je 2,1 ± 1,1 μg/ml odnosno 32,8 ± 16,9 μg•h/ml.
At baseline, 53% of patients had one or more nodes ≥5 cm, and 51% had ALC ≥25 x 109/l. 
Na početku ispitivanja, 53% bolesnika imalo je jedan ili više čvorova ≥ 5 cm, dok ih je 51% imalo apsolutan broj limfocita ≥ 25 x 109/l.
PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (7 day pack) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (7-dnevno pakiranje)
Women of childbearing potential/Contraception in females Women should avoid becoming pregnant while taking Venclyxto and for at least 30 days after ending treatment. 
Žene trebaju izbjegavati trudnoću dok uzimaju Venclyxto i još najmanje 30 dana nakon završetka liječenja.
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. 
Svi događaji bili su laboratorijski utvrđeni TLS (odstupanja laboratorijskih vrijednosti koja su ispunjavala ≥ 2 od sljedećih kriterija u razmaku manjem od 24 sata: kalij > 6 mmol/l, mokraćna kiselina > 476 µmol/l, kalcij < 1,75 mmol/l ili fosfor > 1,5 mmol/l; ili su prijavljeni kao događaji TLS-a), a nastupili su u bolesnika koji su imali limfni(e) čvor(ove) ≥ 5 cm ili apsolutni broj limfocita ≥ 25 x 109/l.
In the open-label, randomised phase 3 study (MURANO), the incidence of TLS was 3% (6/194) in patients treated with venetoclax + rituximab. 
U otvorenom, randomiziranom ispitivanju faze 3 (MURANO), incidencija TLS-a u bolesnika liječenih venetoklaksom + rituksimabom iznosila je 3% (6/194).
• dark or cloudy urine 
• tamnu ili mutnu mokraću
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. 
Bolesnici s velikim opterećenjem tumorskom masom (npr. bilo kojim limfnim čvorom promjera ≥ 5 cm ili visokim apsolutnim brojem limfocita [≥ 25 x 109/l]) imaju veći rizik od TLS-a pri uvođenju venetoklaksa.
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). 
Dozu venetoklaksa koja se koristila prije uvođenja inhibitora CYP3A treba ponovno uvesti 2 do 3 dana nakon prekida primjene inhibitora (vidjeti dijelove 4.4 i 4.5).
• the starting dose is 20 mg (two 10 mg tablets) once a day for 7 days. 
• početna doza je 20 mg (dvije tablete od 10 mg) jedanput na dan tijekom 7 dana
aOne patient did not harbour the 17p deletion. 
TTR, mjeseci, medijan (raspon) aJedan bolesnik nije imao deleciju 17p.
These patients should be monitored more closely for signs of toxicity (see section 4.8). 
Te bolesnike je potrebno pažljivije nadzirati zbog mogućih znakova toksičnosti (vidjeti dio 4.8).
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). 
možda biti potrebna hospitalizacija na dan primjene prve doze venetoklaksa radi intenzivnije profilakse i praćenja tijekom prva 24 sata (vidjeti dio 4.8).
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). 
Istodobna primjena venetoklaksa sa snažnim ili umjerenim inhibitorima CYP3A povećava izloženost venetoklaksu i može povećati rizik od TLS-a pri uvođenju liječenja i tijekom faze titracije doze kao i rizik od drugih toksičnosti (vidjeti dio 4.5).
More intensive measures (intravenous hydration, frequent monitoring, hospitalisation) should be employed as overall risk increases. 
Kako se ukupan rizik povećava, potrebno je uvesti i intenzivnije mjere (intravensku hidraciju, česte kontrole, hospitalizaciju).
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). 
Istodobna primjena venetoklaksa sa snažnim inhibitorima CYP3A pri uvođenju liječenja i tijekom faze titracije doze je kontraindicirana (vidjeti dijelove 4.3, 4.4 i 4.5).
• clarithromycin for bacterial infections 
• klaritromicinom, za liječenje bakterijskih infekcija • ritonavirom, za liječenje HIV infekcije
- 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). 
- ako na početku liječenja i tijekom razdoblja postupnog povećavanja doze (a koje obično traje
Response rate ORR, % (95% CI) 
Stopa odgovora ORR, % (95% CI)
How to take Venclyxto 
Kako uzimati Venclyxto
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. 
cMeđu bolesnicima za koje su bili dostupni nalazi testiranja na MRD u perifernoj krvi, 72,5% (121/167) bolesnika u skupini liječenoj venetoklaksom + rituksimabom i 20% (26/128)
In 168 patients with CLL starting with a daily dose of 20 mg and increasing over 5 weeks to a daily dose of 400 mg in studies M13-982 and M14-032, the rate of TLS was 2%. 
5 tjedana povećavala do dnevne doze od 400 mg u ispitivanjima M13-982 i M14-032, stopa TLS-a iznosila je 2%.
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. 
Bolesnici s velikim opterećenjem tumorskom masom (npr. bilo kojim limfnim čvorom promjera ≥ 5 cm ili visokim apsolutnim brojem limfocita ≥ 25 x 109/l) imaju veći rizik od TLS-a pri uvođenju venetoklaksa.
25 (19.2, NR) 
25 (19,2; NP)
Figure 1: Kaplan-Meier curves of investigator-assessed progression-free survival (intent-to-treat population) in MURANO (data cut-off date 8 May 2018) 
Slika 1: Kaplan-Meierove krivulje preživljenja bez progresije bolesti (populacija predviđena za liječenje) prema ocjeni ispitivača u ispitivanju MURANO (završni datum prikupljanja podataka:
Minimal residual disease (MRD) was evaluated using flow cytometry in 93 of 158 patients who achieved complete remission (CR), complete remission with incomplete marrow recovery (CRi), or partial remission (PR) with limited remaining disease with venetoclax treatment. 
Minimalna rezidualna bolest (engl. minimal residual disease, MRD) ocjenjivala se protočnom citometrijom u 93 od 158 bolesnika koji su liječenjem venetoklaksom postigli potpunu remisiju,
Investigator assessment (N=158)b 
(N=158)b
Bile acid sequestrants 
Sekvestranti žučne kiseline
• In the tablet core: copovidone (K 28), polysorbate 80 (E433), colloidal anhydrous silica (E551), 
• U jezgri tablete: kopovidon (K 28), polisorbat 80 (E433), bezvodni koloidni silicijev dioksid
Median, months (95% CI) 
Medijan, mjeseci (95% CI)
Patients should be particularly instructed to drink 1.5 to 2.0 L of water daily, 2 days prior to and the days of dosing at initiation and each subsequent dose increase. 
Bolesnike osobito treba uputiti da 2 dana prije i na dan primjene doze na početku liječenja i pri svakom sljedećem povećanju doze svakodnevno popiju 1,5 do 2 l vode.
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%. 
Istodobna primjena rifampina, snažnog induktora CYP3A, u dozi od 600 mg jedanput na dan tijekom 13 dana u 10 zdravih ispitanika smanjila je Cmax venetoklaksa za 42%, a AUC∞ za 71%.
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%. 
CYP3A mora primijeniti, početnu dozu venetoklaksa i doze tijekom faze titracije (vidjeti dio 4.2) treba smanjiti za najmanje 50%.
• 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 
u prisutnosti delecije 17p ili mutacije gena TP53 u odraslih bolesnika koji nisu pogodni za liječenje inhibitorom signalnih puteva B-staničnih receptora ili nisu na njega odgovorili, ili u odsustvu delecije 17p ili mutacije gena TP53 u odraslih bolesnika koji nisu odgovorili ni na kemoimunoterapiju ni na liječenje inhibitorom signalnih puteva
At baseline, 41% of patients had one or more nodes ≥5 cm and 31% had ALC ≥25 x 109/l. 
Na početku ispitivanja, 41% bolesnika imalo je jedan ili više čvorova ≥ 5 cm, dok ih je 31% imalo apsolutni broj limfocita ≥ 25 x 109/l.
Blood chemistries should be monitored and abnormalities managed promptly. 
Treba nadzirati biokemijske parametre krvi i odmah korigirati sva odstupanja od normalnih vrijednosti.
Tumour lysis syndrome Hyperkalaemia Hyperphosphataemia Hypocalcaemia 
Poremećaji metabolizma i prehrane vrlo često hiperkalijemija hiperfosfatemija hipokalcijemija često sindrom lize tumora hiperuricemija sindrom lize tumora hiperkalijemija hiperfosfatemija hipokalcijemija manje često hiperuricemija
Hazard ratio (95% CI) P-valuea 
Omjer hazarda (95% CI) P-vrijednosta
• 5 tablets (5 blisters each with 1 tablet) 
• 5 tableta (5 blistera, svaki s 1 tabletom)
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). 
(CrCl ≥ 30 ml/min i < 90 ml/min) (vidjeti dio 5.2).
Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax as they contain inhibitors of CYP3A. 
Seville) i zvjezdasto voće (karambolu) jer oni sadrže inhibitore CYP3A.
The frequencies of adverse reactions reported with Venclyxto are summarised in Table 3. 
Učestalost nuspojava prijavljenih uz Venclyxto sažeto je prikazana u Tablici
Venetoclax daily dose 
Dnevna doza venetoklaksa
Common (may affect up to 1 in 10 people) 
Sindrom lize tumora (često - može se javiti u do 1 na 10 osoba)
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. 
Prema populacijskoj farmakokinetičkoj analizi koja je obuhvatila 219 ispitanika s blagim oštećenjem bubrežne funkcije (CrCl ≥ 60 i < 90 ml/min), 86 ispitanika s umjerenim oštećenjem bubrežne funkcije
Patients randomised to BR received bendamustine at 70 mg/m2 on Days 1 and 2 
Bolesnici randomizirani za protokol BR primali su bendamustin u dozi od 70 mg/m2 1. i 2. dana tijekom 6 ciklusa te rituksimab na prethodno opisan način.
Co-administration of 400 mg once daily ketoconazole, a strong CYP3A, P-gp and BCRP inhibitor, for 7 days in 11 previously treated patients with NHL increased venetoclax Cmax by 2.3-fold and AUC∞ by 6.4-fold. 
Istodobna primjena ketokonazola, snažnog inhibitora CYP3A, P-gp-a i BCRP-a, u dozi od 400 mg jedanput na dan tijekom 7 dana u 11 prethodno liječenih bolesnika s NHL-om povećala je Cmax venetoklaksa 2,3 puta, a AUC∞ 6,4 puta.
Grade ≥3a 
≥ 3. stupnjaa
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. 
Za bolesnike s delecijom 17p i/ili mutacijom gena TP53, ORR je iznosio 72% (33/46) (95% CI: 56,5; 84,0) u skupini A i 67% (8/12) (95% CI: 34,9; 90,1) u skupini B.
Dose interruptions or reductions are recommended for patients with severe neutropenia (see section 4.2). 
U bolesnika s teškom neutropenijom preporučuje se privremeni prekid primjene ili smanjenje doze (vidjeti dio 4.2).
What Venclyxto is used for 
Za što se Venclyxto koristi
Dose modifications for tumour lysis syndrome 
Prilagodbe doze kod sindroma lize tumora
• muscle pain or uncomfortable joints 
• neobičan umor • bol u mišićima ili nelagodu u zglobovima
Keep this medicine out of the sight and reach of children. 
Kako čuvati Venclyxto Lijek čuvajte izvan pogleda i dohvata djece.
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. 
Blijedožuta, ovalna, bikonveksna tableta duljine 17,2 mm i širine 9,5 mm, s utisnutom oznakom 'V' na jednoj strani i '100' na drugoj strani.
• 7 tablets (7 blisters each with 1 tablet) 
• 7 tableta (7 blistera, svaki s 1 tabletom)
PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON Multipack (with blue box) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - višestruko pakiranje (uključujući plavi okvir)
In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection. 
Najčešće nuspojave u ispitivanjima monoterapije bile su neutropenija/smanjen broj neutrofila, proljev, mučnina,
• 14 tablets (7 blisters each with 2 tablets) 
• 14 tableta (7 blistera, svaki s 2 tablete)
Coadministration of 50 mg once daily ritonavir, a strong CYP3A and P-gp inhibitor, for 14 days in 6 healthy subjects increased venetoclax Cmax by 2.4-fold and AUC by 7.9-fold. 
Istodobna primjena ritonavira, snažnog inhibitora CYP3A i P-gp-a, u dozi od 50 mg jedanput na dan tijekom 14 dana u 6 zdravih ispitanika povećala je Cmax venetoklaksa 2,4 puta, a AUC 7,9 puta.
You should start drinking at least 1.5 to 2 litres of water daily two days before starting Venclyxto. 
Trebate početi piti najmanje 1,5 - 2 litre vode na dan dva dana prije nego što počnete uzimati
Post-titration dose for venetoclax monotherapy 
Doza venetoklaksa u monoterapiji nakon titracije
Return to your normal dose schedule the next day. 
Nastavite s primjenom sutradan prema uobičajenom rasporedu.
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). 
Treba izbjegavati istodobnu primjenu venetoklaksa s inhibitorima P-gp-a i BCRP-a pri uvođenju liječenja i tijekom faze titracije doze; ako se inhibitor P-gp-a i BCRP-a mora primijeniti,
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. 
U ispitivanju interakcija s drugim lijekovima, provedenom u tri zdrava dobrovoljca, primjena jednokratne doze venetoklaksa od 400 mg zajedno s 5 mg varfarina povećala je Cmax i AUC∞
Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets 
Venclyxto 10 mg filmom obložene tablete Venclyxto 50 mg filmom obložene tablete Venclyxto 100 mg filmom obložene tablete
Package leaflet: Information for the patient Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets venetoclax This medicine is subject to additional monitoring. 
Uputa o lijeku: Informacije za bolesnika Venclyxto 10 mg filmom obložene tablete Venclyxto 50 mg filmom obložene tablete Venclyxto 100 mg filmom obložene tablete venetoklaks
The film-coated tablets are supplied in cartons containing either 10 or 14 tablets (in blisters of 2 tablets). 
Venclyxto 10 mg tablete Filmom obložene tablete dolaze u kutijama koje sadrže 10 ili 14 tableta (u blisterima s 2 tablete).
AbbVie Kft. Tel:+36 1 455 8600 
Tel:+36 1 455 8600
- 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 
- lijekove za gljivične infekcije - flukonazol, itrakonazol, ketokonazol, posakonazol ili vorikonazol - antibiotike koji se koriste za liječenje bakterijskih infekcija - ciprofloksacin, klaritromicin,
Urinary tract infection Upper respiratory tract infection 
anemija, umor i infekcija gornjih dišnih putova.
• fits or seizures 
• mučnina ili povraćanje
• 10 tablets (5 blisters each with 2 tablets) 
• 10 tableta (5 blistera, svaki s 2 tablete)
Venclyxto 100 mg film-coated tablets 3 years. 
Venclyxto 100 mg filmom obložene tablete 3 godine.
The median time on treatment at the time of evaluation was 12 months (range: 0 to 22 months). 
Medijan trajanja liječenja u trenutku ocjenjivanja iznosio je 12 mjeseci (raspon:
OS = overall survival; PFS = progression-free survival, PR = partial remission, TTR = time to first response. 
ND = nije dostupno; NP = nije postignuto; ORR = stopa ukupnog odgovora; PFS = preživljenje bez progresije bolesti; PR = djelomična remisija; TTR (engl. time to first response) = vrijeme do prvog odgovora.
Film-coated tablet 14 film-coated tablets 
Filmom obložena tableta 14 filmom obloženih tableta
• the dose will be increased to 50 mg (one 50 mg tablet) once a day for 7 days. 
• doza će se povećati na 50 mg (jedna tableta od 50 mg) jedanput na dan tijekom 7 dana
What Venclyxto is and what it is used for 2. 
Što je Venclyxto i za što se koristi
Concomitant use of this medicinal product with strong or moderate CYP3A inhibitors increases venetoclax exposure and may increase the risk for TLS at initiation and during the dose-titration phase (see sections 4.2 and 4.3). 
Istodobna primjena ovog lijeka sa snažnim ili umjerenim inhibitorima CYP3A povećava izloženost venetoklaksu i može povećati rizik od TLS-a pri uvođenju liječenja i tijekom faze titracije doze
Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax (see section 4.5). 
Tijekom liječenja venetoklaksom treba izbjegavati proizvode od grejpa, gorke naranče (sorta Seville) i zvjezdasto voće (karambolu).
Prevention of tumour lysis syndrome (TLS) 
Prevencija sindroma lize tumora (engl.
Film-coated tablet 7 film-coated tablets 
Filmom obložena tableta 7 filmom obloženih tableta
Blood creatinine increased aOnly the highest frequency observed in the trials is reported (based on studies MURANO, M13-982, M14032, and M12-175). 
MURANO, M13-982, M14-032 i M12-175).
Beige, oblong biconvex shaped tablet 14 mm long, 8 mm wide debossed with V on one side and 50 on the other. 
Bež, ovalna, bikonveksna tableta duljine 14 mm i širine 8 mm, s utisnutom oznakom 'V' na jednoj strani i '50' na drugoj strani.
The film-coated tablets are supplied in cartons containing either 5 or 7 tablets(in blisters of 1 tablet). 
Venclyxto 50 mg tablete Filmom obložene tablete dolaze u kutijama koje sadrže 5 ili 7 tableta (u blisterima s 1 tabletom).
• the dose will be increased to 400 mg (four 100 mg tablets) once a day for 7 days. 
• doza će se povećati na 400 mg (četiri tablete od 100 mg) jedanput na dan tijekom 7 dana.
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. 
Do prekida liječenja zbog nuspojava došlo je u 16% bolesnika liječenih kombinacijom venetoklaksa i rituksimaba u ispitivanju MURANO.
CI = confidence interval; CR = complete remission; CRi = complete remission with incomplete marrow recovery, nPR = nodular PR; NR = not reached, ORR = overall response rate;. 
CI = interval pouzdanosti; CR = potpuna remisija; CRi = potpuna remisija uz nepotpun oporavak koštane srži; IRC = neovisno ocjenjivačko povjerenstvo; nPR = nodularna djelomična remisija;
Film-coated tablet 10 film-coated tablets 
Filmom obložena tableta 10 filmom obloženih tableta
Venclyxto 100 mg film-coated tablet is pale yellow, oblong 17.2 mm long with V on one side and 100 on the other. 
Venclyxto 100 mg filmom obložena tableta je blijedožuta, ovalna tableta duljine 17,2 mm, s oznakom 'V' na jednoj strani i '100' na drugoj strani.
Venclyxto 100 mg tablets 
Venclyxto 100 mg tablete
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. 
Venclyxto je u kombinaciji s rituksimabom indiciran za liječenje kronične limfocitne leukemije (KLL)
Tumour lysis syndrome (common - may affect up to 1 in 10 people) Stop taking Venclyxto and seek medical attention immediately if you notice any of the symptoms of TLS: 
Prestanite uzimati Venclyxto i odmah potražite liječničku pomoć ako primijetite bilo koji od simptoma
CI = confidence interval; CR = complete remission; CRi = complete remission with incomplete marrow recovery, DOR = duration of response; IRC = independent review committee; nPR = nodular PR; NA = not available; NR = not reached; ORR = overall response rate; PFS = progression-free survival, PR = partial remission; TTR = time to first response. 
(n=48) CI = interval pouzdanosti; CR = potpuna remisija; CRi = potpuna remisija uz nepotpun oporavak koštane srži; nPR = nodularna djelomična remisija; NP = nije postignuto; ORR = stopa ukupnog odgovora; OS (engl. overall survival) = ukupno preživljenje; PFS = preživljenje bez progresije bolesti; PR = djelomična remisija; TTR = vrijeme do prvog odgovora.
Venclyxto 50 mg film-coated tablets 2 years. 
Venclyxto 50 mg filmom obložene tablete 2 godine.
Each film-coated tablet contains 100 mg venetoclax 
Jedna filmom obložena tableta sadrži 100 mg venetoklaksa
Each film-coated tablet contains 50 mg venetoclax 
Jedna filmom obložena tableta sadrži 50 mg venetoklaksa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
• lijekove za snižavanje razine kolesterola u krvi koji se zovu statini Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koje ste nabavili bez recepta te biljne lijekove i dodatke prehrani.
Venclyxto 50 mg film-coated tablet is beige, oblong 14 mm long, with V on one side and 50 on the other. 
Venclyxto 50 mg filmom obložena tableta je bež, ovalna tableta duljine 14 mm, s oznakom 'V' na jednoj strani i '50' na drugoj strani.
Hydration 
Hidracija
Each film-coated tablet contains 10 mg venetoclax 
Jedna filmom obložena tableta sadrži 10 mg venetoklaksa
The cut-off for a negative status was one CLL cell per 104 leukocytes. 
KLL-a na 104 leukocita.
The efficacy data were further evaluated by an IRC demonstrating a combined ORR of 70% (Arm A: 70%; 
Podatke o djelotvornosti dodatno je ocijenio IRC, pri čemu je utvrđen objedinjen ORR od
Venclyxto 10 mg film-coated tablets 2 years. 
Venclyxto 10 mg filmom obložene tablete 2 godine.
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. 
Dvadeset i sedam posto bolesnika (42/158) imalo je negativan nalaz na MRD
Venclyxto 10 mg film-coated tablet is pale yellow, round 6 mm diameter, with V on one side and 10 on the other. 
Venclyxto 10 mg filmom obložena tableta je blijedožuta, okrugla tableta promjera 6 mm, s oznakom 'V' na jednoj strani i '10' na drugoj strani.