FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: 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.
English: 25 (19.2, NR)
Croatian: 25 (19,2; NP)
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)
Croatian: Slika 1: Kaplan-Meierove krivulje preživljenja bez progresije bolesti (populacija predviđena za liječenje) prema ocjeni ispitivača u ispitivanju MURANO (završni datum prikupljanja podataka:
English: 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.
Croatian: Minimalna rezidualna bolest (engl. minimal residual disease, MRD) ocjenjivala se protočnom citometrijom u 93 od 158 bolesnika koji su liječenjem venetoklaksom postigli potpunu remisiju,
English: Investigator assessment (N=158)b
Croatian: (N=158)b
English: Bile acid sequestrants
Croatian: Sekvestranti žučne kiseline
English: • In the tablet core: copovidone (K 28), polysorbate 80 (E433), colloidal anhydrous silica (E551),
Croatian: • U jezgri tablete: kopovidon (K 28), polisorbat 80 (E433), bezvodni koloidni silicijev dioksid
English: Median, months (95% CI)
Croatian: Medijan, mjeseci (95% CI)
English: 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.
Croatian: 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.
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%.
Croatian: 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%.
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%.
Croatian: CYP3A mora primijeniti, početnu dozu venetoklaksa i doze tijekom faze titracije (vidjeti dio 4.2) treba smanjiti za najmanje 50%.
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
Croatian: 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
English: At baseline, 41% of patients had one or more nodes ≥5 cm and 31% had ALC ≥25 x 109/l.
Croatian: 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.
English: Blood chemistries should be monitored and abnormalities managed promptly.
Croatian: Treba nadzirati biokemijske parametre krvi i odmah korigirati sva odstupanja od normalnih vrijednosti.
English: Tumour lysis syndrome Hyperkalaemia Hyperphosphataemia Hypocalcaemia
Croatian: Poremećaji metabolizma i prehrane vrlo često hiperkalijemija hiperfosfatemija hipokalcijemija često sindrom lize tumora hiperuricemija sindrom lize tumora hiperkalijemija hiperfosfatemija hipokalcijemija manje često hiperuricemija
English: Hazard ratio (95% CI) P-valuea
Croatian: Omjer hazarda (95% CI) P-vrijednosta
English: • 5 tablets (5 blisters each with 1 tablet)
Croatian: • 5 tableta (5 blistera, svaki s 1 tabletom)
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).
Croatian: (CrCl ≥ 30 ml/min i < 90 ml/min) (vidjeti dio 5.2).
English: Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax as they contain inhibitors of CYP3A.
Croatian: Seville) i zvjezdasto voće (karambolu) jer oni sadrže inhibitore CYP3A.
English: The frequencies of adverse reactions reported with Venclyxto are summarised in Table 3.
Croatian: Učestalost nuspojava prijavljenih uz Venclyxto sažeto je prikazana u Tablici
English: Venetoclax daily dose
Croatian: Dnevna doza venetoklaksa
English: Common (may affect up to 1 in 10 people)
Croatian: Sindrom lize tumora (često - može se javiti u do 1 na 10 osoba)
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.
Croatian: 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
English: Patients randomised to BR received bendamustine at 70 mg/m2 on Days 1 and 2
Croatian: 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.
English: 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.
Croatian: 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.
English: Grade ≥3a
Croatian: ≥ 3. stupnjaa
English: The ORR for patients with 17p deletion and/or TP53 mutation was 72% (33/46) (95% CI: 56.5, 84.0) in Arm A and 67% (8/12) (95% CI: 34.9, 90.1) in Arm B. For patients without 17p deletion and/or TP53 mutation, the ORR was 69% (31/45) (95% CI: 53.4, 81.8) in Arm A and 71% (17/24) (95% CI: 48.9, 87.4) in Arm B.
Croatian: 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.
English: Dose interruptions or reductions are recommended for patients with severe neutropenia (see section 4.2).
Croatian: U bolesnika s teškom neutropenijom preporučuje se privremeni prekid primjene ili smanjenje doze (vidjeti dio 4.2).
English: What Venclyxto is used for
Croatian: Za što se Venclyxto koristi
English: Dose modifications for tumour lysis syndrome
Croatian: Prilagodbe doze kod sindroma lize tumora
English: • muscle pain or uncomfortable joints
Croatian: • neobičan umor • bol u mišićima ili nelagodu u zglobovima
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Venclyxto Lijek čuvajte izvan pogleda i dohvata djece.
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.
Croatian: 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.
English: • 7 tablets (7 blisters each with 1 tablet)
Croatian: • 7 tableta (7 blistera, svaki s 1 tabletom)
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON Multipack (with blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - višestruko pakiranje (uključujući plavi okvir)
English: In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.
Croatian: Najčešće nuspojave u ispitivanjima monoterapije bile su neutropenija/smanjen broj neutrofila, proljev, mučnina,
English: • 14 tablets (7 blisters each with 2 tablets)
Croatian: • 14 tableta (7 blistera, svaki s 2 tablete)
English: 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.
Croatian: 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.
English: You should start drinking at least 1.5 to 2 litres of water daily two days before starting Venclyxto.
Croatian: Trebate početi piti najmanje 1,5 - 2 litre vode na dan dva dana prije nego što počnete uzimati
English: Post-titration dose for venetoclax monotherapy
Croatian: Doza venetoklaksa u monoterapiji nakon titracije
English: Return to your normal dose schedule the next day.
Croatian: Nastavite s primjenom sutradan prema uobičajenom rasporedu.
English: Concomitant use of venetoclax with P-gp and BCRP inhibitors at initiation and during the dose-titration phase should be avoided; if a P-gp and BCRP inhibitor must be used, patients should be monitored closely for signs of toxicities (see section 4.4).
Croatian: 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,
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.
Croatian: 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∞
English: Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets
Croatian: Venclyxto 10 mg filmom obložene tablete Venclyxto 50 mg filmom obložene tablete Venclyxto 100 mg filmom obložene tablete
English: 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.
Croatian: 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
English: The film-coated tablets are supplied in cartons containing either 10 or 14 tablets (in blisters of 2 tablets).
Croatian: Venclyxto 10 mg tablete Filmom obložene tablete dolaze u kutijama koje sadrže 10 ili 14 tableta (u blisterima s 2 tablete).
English: AbbVie Kft. Tel:+36 1 455 8600
Croatian: Tel:+36 1 455 8600
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
Croatian: - lijekove za gljivične infekcije - flukonazol, itrakonazol, ketokonazol, posakonazol ili vorikonazol - antibiotike koji se koriste za liječenje bakterijskih infekcija - ciprofloksacin, klaritromicin,
English: Urinary tract infection Upper respiratory tract infection
Croatian: anemija, umor i infekcija gornjih dišnih putova.
English: • fits or seizures
Croatian: • mučnina ili povraćanje
English: • 10 tablets (5 blisters each with 2 tablets)
Croatian: • 10 tableta (5 blistera, svaki s 2 tablete)
English: Venclyxto 100 mg film-coated tablets 3 years.
Croatian: Venclyxto 100 mg filmom obložene tablete 3 godine.
English: The median time on treatment at the time of evaluation was 12 months (range: 0 to 22 months).
Croatian: Medijan trajanja liječenja u trenutku ocjenjivanja iznosio je 12 mjeseci (raspon:
English: OS = overall survival; PFS = progression-free survival, PR = partial remission, TTR = time to first response.
Croatian: 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.
English: Film-coated tablet 14 film-coated tablets
Croatian: Filmom obložena tableta 14 filmom obloženih tableta
English: • the dose will be increased to 50 mg (one 50 mg tablet) once a day for 7 days.
Croatian: • doza će se povećati na 50 mg (jedna tableta od 50 mg) jedanput na dan tijekom 7 dana
English: What Venclyxto is and what it is used for 2.
Croatian: Što je Venclyxto i za što se koristi
English: 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).
Croatian: 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
English: Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax (see section 4.5).
Croatian: Tijekom liječenja venetoklaksom treba izbjegavati proizvode od grejpa, gorke naranče (sorta Seville) i zvjezdasto voće (karambolu).
English: Prevention of tumour lysis syndrome (TLS)
Croatian: Prevencija sindroma lize tumora (engl.
English: Film-coated tablet 7 film-coated tablets
Croatian: Filmom obložena tableta 7 filmom obloženih tableta
English: Blood creatinine increased aOnly the highest frequency observed in the trials is reported (based on studies MURANO, M13-982, M14032, and M12-175).
Croatian: MURANO, M13-982, M14-032 i M12-175).
English: Beige, oblong biconvex shaped tablet 14 mm long, 8 mm wide debossed with V on one side and 50 on the other.
Croatian: Bež, ovalna, bikonveksna tableta duljine 14 mm i širine 8 mm, s utisnutom oznakom 'V' na jednoj strani i '50' na drugoj strani.
English: The film-coated tablets are supplied in cartons containing either 5 or 7 tablets(in blisters of 1 tablet).
Croatian: Venclyxto 50 mg tablete Filmom obložene tablete dolaze u kutijama koje sadrže 5 ili 7 tableta (u blisterima s 1 tabletom).
English: • the dose will be increased to 400 mg (four 100 mg tablets) once a day for 7 days.
Croatian: • doza će se povećati na 400 mg (četiri tablete od 100 mg) jedanput na dan tijekom 7 dana.
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.
Croatian: Do prekida liječenja zbog nuspojava došlo je u 16% bolesnika liječenih kombinacijom venetoklaksa i rituksimaba u ispitivanju MURANO.
English: CI = confidence interval; CR = complete remission; CRi = complete remission with incomplete marrow recovery, nPR = nodular PR; NR = not reached, ORR = overall response rate;.
Croatian: CI = interval pouzdanosti; CR = potpuna remisija; CRi = potpuna remisija uz nepotpun oporavak koštane srži; IRC = neovisno ocjenjivačko povjerenstvo; nPR = nodularna djelomična remisija;
English: Film-coated tablet 10 film-coated tablets
Croatian: Filmom obložena tableta 10 filmom obloženih tableta
English: Venclyxto 100 mg film-coated tablet is pale yellow, oblong 17.2 mm long with V on one side and 100 on the other.
Croatian: 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.
English: Venclyxto 100 mg tablets
Croatian: Venclyxto 100 mg tablete
English: Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Croatian: Venclyxto je u kombinaciji s rituksimabom indiciran za liječenje kronične limfocitne leukemije (KLL)
English: 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:
Croatian: Prestanite uzimati Venclyxto i odmah potražite liječničku pomoć ako primijetite bilo koji od simptoma
English: 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.
Croatian: (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.
English: Venclyxto 50 mg film-coated tablets 2 years.
Croatian: Venclyxto 50 mg filmom obložene tablete 2 godine.
English: Each film-coated tablet contains 100 mg venetoclax
Croatian: Jedna filmom obložena tableta sadrži 100 mg venetoklaksa
English: Each film-coated tablet contains 50 mg venetoclax
Croatian: Jedna filmom obložena tableta sadrži 50 mg venetoklaksa
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: • 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.
English: Venclyxto 50 mg film-coated tablet is beige, oblong 14 mm long, with V on one side and 50 on the other.
Croatian: Venclyxto 50 mg filmom obložena tableta je bež, ovalna tableta duljine 14 mm, s oznakom 'V' na jednoj strani i '50' na drugoj strani.
English: Hydration
Croatian: Hidracija
English: Each film-coated tablet contains 10 mg venetoclax
Croatian: Jedna filmom obložena tableta sadrži 10 mg venetoklaksa
English: The cut-off for a negative status was one CLL cell per 104 leukocytes.
Croatian: KLL-a na 104 leukocita.
English: The efficacy data were further evaluated by an IRC demonstrating a combined ORR of 70% (Arm A: 70%;
Croatian: Podatke o djelotvornosti dodatno je ocijenio IRC, pri čemu je utvrđen objedinjen ORR od
English: Venclyxto 10 mg film-coated tablets 2 years.
Croatian: Venclyxto 10 mg filmom obložene tablete 2 godine.
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.
Croatian: Dvadeset i sedam posto bolesnika (42/158) imalo je negativan nalaz na MRD
English: Venclyxto 10 mg film-coated tablet is pale yellow, round 6 mm diameter, with V on one side and 10 on the other.
Croatian: Venclyxto 10 mg filmom obložena tableta je blijedožuta, okrugla tableta promjera 6 mm, s oznakom 'V' na jednoj strani i '10' na drugoj strani.
English: Film-coated tablet 5 film-coated tablets
Croatian: Filmom obložena tableta 5 filmom obloženih tableta
English: Iron oxide yellow (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b)
Croatian: Film ovojnica željezov oksid, žuti (E172) poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol 3350 (E1521) talk (E553b)
English: • the dose will be increased to 200 mg (two 100 mg tablets) once a day for 7 days.
Croatian: • doza će se povećati na 200 mg (dvije tablete od 100 mg) jedanput na dan tijekom 7 dana
English: Tel: + 385 (0)1 5625 501
Croatian: AbbVie d.o.o. Tel: + 385 (0)1 5625 501
English: ORR, % (95% CI)
Croatian: PFS, % (95% CI)
English: Tumour lysis syndrome, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with venetoclax.
Croatian: U bolesnika s prethodno liječenim KLL-om i velikim opterećenjem tumorskom masom, pri liječenju venetoklaksom zabilježen je sindrom lize tumora, uključujući slučajeve sa smrtnim ishodom.
English: In vitro studies indicated that venetoclax is not an inhibitor or inducer of CYP1A2, CYP2B6, CYP2C19, CYP2D6 or CYP3A4 at clinically relevant concentrations.
Croatian: CYP2C19, CYP2D6 ni CYP3A4 pri klinički značajnim koncentracijama.
English: • severe infection in the blood (sepsis)
Croatian: Česte (mogu se javiti u do 1 na 10 osoba) • teška infekcija u krvi (sepsa)
English: Low white blood cell count (neutropenia) (very common - may affect more than 1 in 10 people) Your doctor will check your blood count during treatment with Venclyxto.
Croatian: Nizak broj bijelih krvnih stanica (neutropenija) (vrlo često - može se javiti u više od 1 na
English: In the MURANO study, neutropenia was reported in 61% (all grades) of patients on the venetoclax + rituximab arm. Forty-three percent of patients treated with venetoclax + rituximab experienced dose interruption and 3% of patients discontinued venetoclax due to neutropenia.
Croatian: Primjena je privremeno prekinuta u 43% bolesnika liječenih venetoklaksom + rituksimabom, dok je liječenje venetoklaksom zbog neutropenije trajno prekinulo 3% bolesnika.
English: • higher level of potassium
Croatian: • povišene vrijednosti kalija
English: Name and address of the manufacturer(s) responsible for batch release AbbVie Deutschland GmbH & Co. KG Knollstrasse
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet AbbVie
English: • Venclyxto 50 mg film-coated tablets: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b)
Croatian: • Venclyxto 50 mg filmom obložene tablete: žuti željezov oksid (E172), crveni željezov oksid (E172), crni željezov oksid (E172), poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 3350 (E1521), talk (E553b).
English: • the dose will be increased to 100 mg (one 100 mg tablet) once a day for 7 days.
Croatian: • doza će se povećati na 100 mg (jedna tableta od 100 mg) jedanput na dan tijekom 7 dana
English: • Venclyxto 100 mg film-coated tablets: Each film-coated tablet contains 100 mg venetoclax.
Croatian: • Venclyxto 100 mg filmom obložene tablete: jedna filmom obložena tableta sadrži 100 mg venetoklaksa.
English: • Venclyxto 50 mg film-coated tablets: Each film-coated tablet contains 50 mg venetoclax.
Croatian: • Venclyxto 50 mg filmom obložene tablete: jedna filmom obložena tableta sadrži 50 mg venetoklaksa.
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.
Croatian: bolesnika u skupini liječenoj venetoklaksom + rituksimabom i 6,7% (2/30) bolesnika koji su primali bendamustin
English: Venclyxto 50 mg tablets venetoclax
Croatian: Venclyxto 50 mg tablete venetoklaks
English: • Venclyxto 100 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
Croatian: • Venclyxto 100 mg filmom obložene tablete: žuti željezov oksid (E172), poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 3350 (E1521), talk (E553b).