FrancophonIA/ELRC3.0 huggingface dataset:
English: Grade 3 or 4 neutropenia has been reported in patients treated with venetoclax in the combination study with rituximab (GO28667/MURANO) and in the monotherapy studies (see section 4.8).
Slovak: U pacientov liečených venetoklaxom v štúdii v kombinácii s rituximabom (GO28667/MURANO)
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.
Slovak: K ukončeniu liečby v dôsledku nežiaducich reakcií došlo u 16 % pacientov liečených kombináciou venetoklaxu a rituximabu v štúdii MURANO.
English: Tumour lysis syndrome, including fatal events, has occurred in patients with previously treated CLL with high tumour burden when treated with venetoclax.
Slovak: Syndróm z rozpadu nádoru Syndróm z rozpadu nádoru, vrátane fatálnych prípadov, sa vyskytol u pacientov s predtým liečenou CLL
English: Table 6: Efficacy results in patients with previously treated CLL with 17p deletion (study M13-982) Endpoint
Slovak: Tabuľka 6:Výsledky účinnosti u pacientov, ktorí boli predtým liečení na CLL a majú deléciu 17p (štúdia
English: The median time since diagnosis was 6.8 years (range: 0.1 to 32 years; N=106).
Slovak: 6,8 roka (rozsah: 0,1 až 32 roka); (n =
English: MRD negativity was defined as a result below 0.0001 (<1 CLL cell per 104 leukocytes in the sample).
Slovak: MRD negativita sa definovala ako výsledná hodnota nižšia ako 0,0001
English: Pneumonia Upper respiratory tract infection
Slovak: Infekcia horných dýchacích ciest
English: • feeling or being sick (nausea or vomiting)
Slovak: • nevoľnosť alebo vracanie; • pocit zmätenosti;
English: AbbVie Kft. Tel:+36 1 455 8600
Slovak: Tel:+36 1 455 8600
English: Overall, 65% of patients received prior nucleoside analogue, 86% rituximab, 39% other monoclonal antibodies, and 72% alkylating agent (including 41% with bendamustine).
Slovak: rituximabom, 39 % inými monoklonálnymi protilátkami a 72 % alkylačnou látkou (vrátane 41
English: • 5 tablets (5 blisters each with 1 tablet)
Slovak: 5 tabliet (5 blistrov, z ktorých každý obsahuje 1 tabletu);
English: Median, months (95% CI)
Slovak: Medián, mesiace (95 % CI)
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).
Slovak: Súbežné užívanie venetoklaxu a silných inhibítorov CYP3A je kontraindikované pri prvej dávke a počas fázy titrácie dávky (pozri časti 4.3, 4.4 a 4.5).
English: • If you are not sure talk to your doctor, pharmacist or nurse.
Slovak: Ak si nie ste istý, obráťte sa na svojho lekára, lekárnika alebo zdravotnú sestru.
English: • If it is less than 8 hours since the time you usually take your dose, take it as soon as possible.
Slovak: Ak zabudnete užiť Venclyxto • Keď od času, kedy zvyčajne užívate svoju dávku, ubehlo menej ako 8 hodín, užite svoju dávku hneď ako je to možné.
English: How Venclyxto works
Slovak: Ako Venclyxto účinkuje
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
Slovak: Venclyxtom je indikovaná na liečbu CLL: • v prítomnosti delécie 17p alebo mutácie TP53 u dospelých pacientov, u ktorých nie je vhodná alebo zlyhala liečba inhibítorom dráhy B-bunkového receptora, alebo
English: Тел:+359 2 90 30 430
Slovak: България АбВи ЕООД Тел:+359 2 90 30 430
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.
Slovak: cU pacientov s výsledkami testu MRD z periférnej krvi sa zistilo, že 72,5 % pacientov (121/167) v ramene s venetoklaxom
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.
Slovak: Nízky počet bielych krviniek (neutropénia) (veľmi časté - môžu postihnúť viac ako 1 z 10 ľudí)
English: Breast-feeding should be discontinued during treatment with Venclyxto.
Slovak: Počas liečby Venclyxtom sa má dojčenie ukončiť.
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.
Slovak: Svetložltá podlhovastá bikonvexná tableta s dĺžkou 17,2 mm a šírkou 9,5 mm, ktorá má na jednej strane vyrazené písmeno “V“ a na druhej strane číslo “100“.
English: • the dose will be increased to 50 mg (one 50 mg tablet) once a day for 7 days.
Slovak: • dávka sa zvýši na 50 mg (jedna 50 mg tableta) raz denne počas 7 dní.
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:
Slovak: Prerušte užívanie Venclyxta a okamžite vyhľadajte lekársku pomoc, ak spozorujete ktorýkoľvek z príznakov
English: Venclyxto 100 mg film-coated tablets 3 years.
Slovak: Venclyxto 100 mg filmom obalené tablety 3 roky.
English: • medicines that prevent blood clots, warfarin, dabigatran
Slovak: , warfarín, dabigatran;
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.
Slovak: Vo všetkých prípadoch to boli laboratórne TLS (ako prípady TLS sa hlásili abnormality v laboratórnych výsledkoch, ktoré spĺňali ≥ 2 z nasledovných kritérií s maximálne 24-hodinovým odstupom: draslík > 6 mmol/l, kyselina močová > 476 µmol/l, vápnik < 1,75 mmol/l alebo fosfor > 1,5 mmol/l) a vyskytli sa len u pacientov, ktorí mali lymfatickú uzlinu (uzliny) ≥
English: How to store Venclyxto
Slovak: Ako uchovávať Venclyxto
English: You should continue to drink at least 1.5 to 2 litres of water on the day you start Venclyxto.
Slovak: Aj v deň, keď dostanete prvú dávku Venclyxta, musíte pokračovať v pití najmenej 1,5 až 2 litrov vody za deň.
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.
Slovak: Venclyxto 100 mg filmom obalená tableta je svetložltá, podlhovastá tableta s dĺžkou 17,2 mm, ktorá má na jednej strane vyrazené písmeno “V“ a na druhej číslo “100“.
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (7 day pack)
Slovak: ŠKATUĽKA (balenie na 7 dní)
English: Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets
Slovak: Venclyxto 10 mg filmom obalené tablety Venclyxto 50 mg filmom obalené tablety Venclyxto 100 mg filmom obalené tablety
English: Venclyxto 50 mg film-coated tablet is beige, oblong 14 mm long, with V on one side and 50 on the other.
Slovak: Venclyxto 50 mg filmom obalená tableta je béžová podlhovastá tableta s dĺžkou 14 mm, ktorá má na jednej strane vyrazené písmeno “V“ a na druhej číslo “50“.
English: Film-coated tablet 14 film-coated tablets
Slovak: Filmom obalená tableta 14 filmom obalených tabliet
English: Based on population pharmacokinetic analysis, gastric acid reducing agents (e.g., proton pump inhibitors, H2-receptor antagonists, antacids) do not affect venetoclax bioavailability.
Slovak: inhibítory protónovej pumpy, antagonisty H2-receptora, antacidá) negatívny vplyv na biologickú dostupnosť venetoklaxu.
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.
Slovak: V štúdii liekovej interakcie viedlo podanie jednej dávky 400 mg venetoklaxu spolu s 5 mg warfarínu trom zdravým dobrovoľníkom k 18
English: Film-coated tablet 7 film-coated tablets
Slovak: Filmom obalená tableta 7 filmom obalených tabliet
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).
Slovak: Po ukončení užívania inhibítora CYP3A sa má za 2 až 3 dni znova prejsť na takú dávku venetoklaxu, ktorú pacient užíval pred začiatkom užívania tohto inhibítora (pozri časti 4.4 a 4.5).
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).
Slovak: Po ukončení užívania inhibítora CYP3A sa má za 2 až 3 dni znova prejsť na takú dávku venetoklaxu, ktorú pacient užíval pred začiatkom užívania tohto inhibítora (pozri časť 4.2).
English: Investigator assessment (N=158)b
Slovak: Vyhodnotenie skúšajúcim (n =
English: Venclyxto 50 mg film-coated tablets 2 years.
Slovak: Venclyxto 50 mg filmom obalené tablety 2 roky.
English: - Tell your doctor immediately if you become pregnant while you are taking this medicine.
Slovak: - Ak počas užívania tohto lieku otehotniete, okamžite sa obráťte na svojho lekára.
English: After a single oral administration of 200 mg radiolabeled [14C]-venetoclax to healthy subjects, >99.9% of the dose was recovered in faeces and <0.1% of the dose was excreted in urine within 9 days.
Slovak: Po jednorazovej perorálnej dávke 200 mg rádioaktívne značeného [14C]-venetoklaxu zdravým jedincom sa do 9 dní
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%.
Slovak: Ak sa musí použiť stredne silný inhibítor CYP3A, prvá dávka a titračné dávky venetoklaxu sa musia zredukovať aspoň o 50 %. U pacientov sa musia starostlivejšie monitorovať prejavy toxicít (pozri časti 4.4 a 4.5).
English: • 7 tablets (7 blisters each with 1 tablet)
Slovak: • 7 tabliet (7 blistrov, z ktorých každý obsahuje 1 tabletu).
English: • 14 tablets (7 blisters each with 2 tablets)
Slovak: • 14 tabliet (7 blistrov, z ktorých každý obsahuje 2 tablety).
English: Diarrhoea Vomiting Nausea
Slovak: Syndróm z rozpadu nádoru
English: Venclyxto 10 mg film-coated tablets 2 years.
Slovak: Venclyxto 10 mg filmom obalené tablety 2 roky.
English: Film-coated tablet 10 film-coated tablets
Slovak: Filmom obalená tableta 10 filmom obalených tabliet
English: In venetoclax clinical studies, patients with any measurable lymph node ≥10 cm or those with both an ALC ≥25 x 109/l and any measurable lymph node ≥5 cm were hospitalised to enable more intensive hydration and monitoring for the first day of dosing at 20 mg and 50 mg during the titration phase (see section 4.2).
Slovak: 5 cm, aby sa umožnila intenzívnejšia hydratácia a monitorovanie počas prvého dňa podania dávky a v titračnej fáze, keď sa podávalo 20 mg a 50 mg (pozri časť 4.2).
English: In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.
Slovak: V štúdiách monoterapie boli najčastejšie hlásenými závažnými nežiaducimi reakciami (≥
English: Febrile neutropenia Lymphopenia
Slovak: Neutropénia Anémia Lymfopénia
English: Post-titration dose for venetoclax in combination with rituximab
Slovak: Pozorovaný prínos z hľadiska PFS pre venetoklax + rituximab v porovnaní s bendamustínom
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.
Slovak: V štúdii MURANO bola neutropénia (všetkých stupňov) hlásená u 61 % pacientov v skupine s venetoklaxom + rituximabom.
English: At an updated efficacy analysis with all patients off treatment (data cut-off date 8 May 2018 and median follow-up of 36 months) the 36-month PFS estimate in the venetoclax + rituximab arm was 71.4% [95% CI: 64.8, 78.1] and in the bendamustine + rituximab arm was 15.2% [95% CI: 9.1, 21].
Slovak: 2018 a medián sledovania 36 mesiacov) bol 36-mesačný odhad PFS v ramene s venetoklaxom + rituximabom 71,4
English: • the dose will be increased to 400 mg (four 100 mg tablets) once a day for 7 days.
Slovak: • dávka sa zvýši na 400 mg (štyri 100 mg tablety) raz denne počas 7 dní.
English: • the dose will be increased to 200 mg (two 100 mg tablets) once a day for 7 days.
Slovak: • dávka sa zvýši na 200 mg (dve 100 mg tablety) raz denne počas 7 dní.
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (5 day pack)
Slovak: ŠKATUĽKA (balenie na 5 dní)
English: Venclyxto 100 mg tablets
Slovak: Venclyxto 100 mg tablety
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.
Slovak: + rituximab dokončili 5-týždňovú schému titrácie dávky Venclyxta a potom dostávali 400 mg jedenkrát denne počas
English: • Venclyxto 100 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
Slovak: Venclyxto 100 mg filmom obalené tablety: žltý oxid železitý (E172), polyvinylalkohol (E1203), oxid titaničitý (E171), makrogol 3350 (E1521), mastenec (E553b).
English: • 10 tablets (5 blisters each with 2 tablets)
Slovak: 10 tabliet (5 blistrov, z ktorých každý obsahuje 2 tablety);
English: Eighteen patients in the venetoclax + rituximab arm and 3 patients in the bendamustine + rituximab arm had negative bone marrow and lymph nodes <2 cm. bMinimal residual disease was evaluated using allele-specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry.
Slovak: + rituximabom mali negatívnu kostnú dreň a lymfatické uzliny < 2 cm.
English: Venclyxto 10 mg tablets
Slovak: Venclyxto 10 mg tablety
English: • Venclyxto 10 mg film-coated tablets: iron oxide yellow (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).
Slovak: Venclyxto 10 mg filmom obalené tablety: žltý oxid železitý (E172), polyvinylalkohol (E1203), oxid titaničitý (E171), makrogol 3350 (E1521), mastenec (E553b).
English: Film-coated tablet 5 film-coated tablets
Slovak: Filmom obalená tableta 5 filmom obalených tabliet
English: The film-coated tablets are supplied in cartons containing either 5 or 7 tablets(in blisters of 1 tablet).
Slovak: Venclyxto 50 mg tablety Filmom obalené tablety sa dodávajú v škatuľkách obsahujúcich 5 alebo 7 tabliet (v blistroch s 1 tabletou).
English: In the MURANO study, dose interruptions due to adverse reactions occurred in 71% of patients treated with the combination of venetoclax and rituximab; the most common adverse reaction that led to dose interruption of venetoclax was neutropenia (43%).
Slovak: V štúdii MURANO došlo k prerušeniu podávania lieku v dôsledku nežiaducich reakcií u 71 % pacientov liečených kombináciou venetoklaxu a rituximabu.
English: Number of events (%) Disease progression Death events
Slovak: % pacientov, infekcie stupňa ≥ 3
English: The safety and efficacy of venetoclax in 107 patients with previously treated CLL with 17p deletion were evaluated in a single arm, open-label, multi-center study (M13-982).
Slovak: 17p, hodnotila v jednoramennej, otvorenej, multicentrickej štúdii (M13-982).
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.
Slovak: až 1,5-násobok ULN, stredne závažné poškodenie pečene sa definovalo ako celkový bilirubín > 1,5- až
English: • abdominal pain and distension
Slovak: • nevoľnosť a vracanie
English: Venetoclax steady state AUC increased proportionally over the dose range of 150-800 mg.
Slovak: Rovnovážna AUC pre venetoklax sa zvyšovala priamo úmerne s dávkou v rámci dávkového rozsahu 150 až 800 mg. Pri nízkotučnej strave bola priemerná rovnovážna Cmax venetoklaxu (± štandardná odchýlka)
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,
Slovak: % zníženie rizika progresie alebo smrti u pacientov liečených venetoklaxom + rituximabom (pomer rizika: 0,19 [95
English: Tell your doctor if you notice any of the following side effects: Very common
Slovak: Ak zaznamenáte niektorý z nasledovných vedľajších účinkov, obráťte sa na svojho lekára:
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovak: Ak teraz užívate alebo ste v poslednom čase užívali, či práve budete užívať ďalšie lieky, povedzte to svojmu lekárovi a lekárnikovi.
English: Iron oxide yellow (E172) Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b)
Slovak: čierny oxid železitý (E172), polyvinylalkohol (E1203), oxid titaničitý (E171), makrogol 3350
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.
Slovak: negatívnych v periférnej krvi, vrátane 16 pacientov, ktorí boli MRD negatívni aj v kostnej dreni.
English: • the dose will be increased to 100 mg (one 100 mg tablet) once a day for 7 days.
Slovak: • dávka sa zvýši na 100 mg (jedna 100 mg tableta) raz denne počas 7 dní.
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.
Slovak: 30 a < 60 ml/min) a 217 pacientov s normálnou funkciou obličiek (CrCl ≥
English: Venetoclax as monotherapy for the treatment of patients with CLL who have failed a B-cell receptor pathway inhibitor - study M14-032
Slovak: Venetoklax ako monoterapia na liečbu pacientov s CLL, u ktorých zlyhala liečba inhibítorom dráhy B
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovak: Populačný odhad pre zdanlivý distribučný objem
English: Venclyxto 50 mg tablets venetoclax
Slovak: Venclyxto 50 mg tablety venetoklax
English: Venclyxto 10 mg film-coated tablet is pale yellow, round 6 mm diameter, with V on one side and 10 on the other.
Slovak: Venclyxto 10 mg filmom obalená tableta je svetložltá, okrúhla tableta s priemerom 6 mm, ktorá má na jednej strane vyrazené písmeno “V“ a na druhej číslo “10“.
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.
Slovak: 5 cm alebo vysoký absolútny počet lymfocytov [ALC ≥
English: Venclyxto 100 mg tablets venetoclax
Slovak: Venclyxto 100 mg tablety venetoklax
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.
Slovak: + rituximabom bolo negatívnych z hľadiska MRD. dU pacientov s výsledkami testu MRD z kostnej drene sa zistilo, že 76,9 % pacientov (30/39) v ramene s venetoklaxom
English: Each film-coated tablet contains 50 mg venetoclax
Slovak: Každá filmom obalená tableta obsahuje 50 mg venetoklaxu
English: Venclyxto 10 mg tablets venetoclax
Slovak: Venclyxto 10 mg tablety venetoklax
English: Gastric acid reducing agents
Slovak: Liečivá na redukciu žalúdočnej kyseliny
English: Each film-coated tablet contains 10 mg venetoclax
Slovak: Každá filmom obalená tableta obsahuje 10 mg venetoklaxu
English: Each film-coated tablet contains 100 mg venetoclax
Slovak: Každá filmom obalená tableta obsahuje 100 mg venetoklaxu
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.
Slovak: V štúdii zameranej na sledovanie poškodenia funkcie pečene boli Cmax a AUC venetoklaxu po podaní jednorazovej dávky 50 mg venetoklaxu u subjektov s miernou (trieda
English: Venclyxto 50 mg film-coated tablets Each film-coated tablet contains 50 mg of venetoclax.
Slovak: Venclyxto 50 mg filmom obalené tablety: každá filmom obalená tableta obsahuje 50 mg venetoklaxu.
English: Ask your doctor for advice on sperm storage before starting treatment with Venclyxto.
Slovak: Venclyxtom sa poraďte so svojim lekárom o možnosti uchovania spermií.
English: Venclyxto 50 mg film-coated tablets:
Slovak: Venclyxto 50 mg filmom obalené tablety:
English: DOR, months, median (95% CI)
Slovak: Medián DOR, mesiace (95 % CI)
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.
Slovak: U pacientov s vysokou nádorovou záťažou (napr. akákoľvek lymfatická uzlina s priemerom ≥
English: Venclyxto 100 mg film-coated tablets:
Slovak: Venclyxto 100 mg filmom obalené tablety:
English: • Venclyxto 10 mg film-coated tablets: Each film-coated tablet contains 10 mg venetoclax.
Slovak: Venclyxto 10 mg filmom obalené tablety: každá filmom obalená tableta obsahuje 10 mg venetoklaxu.
English: Venetoclax is highly bound to human plasma protein with unbound fraction in plasma <0.01 across a concentration range of 1-30 µM (0.87-26 µg/ml).
Slovak: 0,01 v rámci koncentračného rozsahu 1 - 30 µM (0,87 - 26 µg/ml).
English: In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.
Slovak: + rituximabom prerušilo podávanie lieku a 3 % pacientov ukončilo liečbu venetoklaxom v dôsledku neutropénie.
English: Beige, oblong biconvex shaped tablet 14 mm long, 8 mm wide debossed with V on one side and 50 on the other.
Slovak: Venclyxto 50 mg filmom obalená tableta Béžová podlhovastá bikonvexná tableta s dĺžkou 14 mm a šírkou 8 mm, ktorá má na jednej strane vyrazené písmeno “V“ a na druhej strane číslo “50“.
English: • Venclyxto 100 mg film-coated tablets: Each film-coated tablet contains 100 mg venetoclax.
Slovak: Venclyxto 100 mg filmom obalené tablety: každá filmom obalená tableta obsahuje 100 mg venetoklaxu.
English: Venclyxto 10 mg film-coated tablets:
Slovak: Venclyxto 10 mg filmom obalené tablety:
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
Slovak: Účinnosť a bezpečnosť venetoklaxu sa hodnotili v otvorenej, multicentrickej, nerandomizovanej štúdii fázy 2 (M14-032)
English: At baseline, 41% of patients had one or more nodes ≥5 cm and 31% had ALC ≥25 x 109/l.
Slovak: 5 cm a 31 % malo ALC ≥25 x 109/l.
English: Venclyxto 50 mg film-coated tablets
Slovak: Venclyxto 50 mg filmom obalené tablety
English: Venclyxto 50 mg film-coated tablets venetoclax
Slovak: Venclyxto 50 mg filmom obalené tablety venetoklax
English: • higher level of potassium
Slovak: • zvýšená hladina močoviny
English: Venclyxto 10 mg film-coated tablets
Slovak: Venclyxto 10 mg filmom obalené tablety
English: Keep this medicine out of the sight and reach of children.
Slovak: Ako uchovávať Venclyxto Tento liek uchovávajte mimo dohľadu a dosahu detí.
English: Tumour lysis syndrome Hyperuricaemia
Slovak: Syndróm z rozpadu nádoru Hyperurikémia
English: Venclyxto 10 mg film-coated tablets venetoclax
Slovak: Venclyxto 10 mg filmom obalené tablety venetoklax