FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary efficacy endpoint was overall response rate (ORR) as assessed by an Independent Review Committee (IRC) using the IWCLL updated NCI-WG guidelines (2008).
Maltese: Il-punt aħħari primarju tal-effikaċja kien ir-rata ta' rispons globali (ORR, overall response rate) kif ivvalutata mill-Kumitat Indipendenti tal-Evalwazzjoni (IRC, Independent Review Committee) bl-użu tal-linji gwida tal-IWCLL aġġornati tal-NCI-WG (2008).
English: Patients should be monitored more closely for signs of toxicities (see sections 4.4 and 4.5).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati aktar mill-qrib għal sinjali ta' tossiċitajiet (ara sezzjonijiet 4.4 u 4.5).
English: Progression-free survival (PFS) was assessed by investigators using the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
Maltese: Is-sopravivenza mingħajr progressjoni (PFS) ġiet ivvalutata minn investigaturi li użaw il-Linji ta' Gwida Internazzjonali tal-Grupp ta' Ħidma tal-Workshop għal Linjemika Limfoċitika Kronika (IWCLL) aġġornati mill-Istitut Nazzjonali tal-Kanċer (NCI-WG).
English: In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.
Maltese: Fl-istudji ta' monoterapija b'venetoclax, 11% tal-pazjenti waqfu minħabba reazzjonijiet avversi.
English: Venetoclax binds directly to the BH3-binding groove of BCL-2, displacing BH3 motif-containing pro-apoptotic proteins like BIM, to initiate mitochondrial outer membrane permeabilization (MOMP), caspase activation, and programmed cell death.
Maltese: Venetoclax jeħel direttament mal-kanal li jorbot il-BH3 ta' BCL-2, fejn ineħħi l-proteini preventivi li fihom il-motif tal-BH3 bħal BIM, sabiex jibda lpermeabilizzazzjoni tal-membrana ta' barra mitokondrijali (MOMP), attivazzjoni tal-caspase, u l-mewt taċ ċelluli pprogrammati.
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.
Maltese: Ġiet osservata tossiċità testikulari (telf taċ-ċelluli ġerminali) fl-istudji dwar it-tossiċità ġenerali fil-klieb esponimenti ta' 0.5 sa 18-il darba tal-esponiment tal-AUC tal-bniedem bid-doża rrakkomandata.
English: Co-administration of a 600 mg single dose of rifampin, a P-gp inhibitor, in 11 healthy subjects increased venetoclax Cmax by 106% and AUC∞ by 78%.
Maltese: fi 11-il individwu b'saħħithom żied venetoclax Cmax b'106% u AUC∞ b'78%.
English: Substrates of P-gp, BCRP, and OATP1B1
Maltese: Sottostrati ta' P-gp, BCRP, u OATP1B1 Venetoclax huwa inibitur in vitro ta' P-gp, BCRP u OATP1B1.
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (7 day pack)
Maltese: KARTUNA (pakkett ta' 7 ijiem)
English: The median age was 66 years (range: 28 to 85 years), 70% were male, and 92% were white.
Maltese: L-età medjana kienet ta' 66 sena (firxa: 28 sa 85 sena), 70% kienu rġiel, u 92% kienu bojod.
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%.
Maltese: L-għoti flimkien ta' rifampin ta' 600 mg darba kuljum, induttur CYP3A b'saħħtu, għal 13-il jum f'10 individwi b'saħħithom naqqas venetoclax Cmax b'42% u AUC∞ b'71%.
English: • medicines that prevent blood clots, warfarin, dabigatran
Maltese: • mediċini li jipprevjenu l-koagulazzjoni tad-demm bħal warfarin, dabigatran
English: • In the tablet core: copovidone (K 28), polysorbate 80 (E433), colloidal anhydrous silica (E551),
Maltese: • Fil-qalba tal-pillola: copovidone, (K 28), polysorbate 80 (E433), colloidal anhydrous silica (E551), anydrous calcium hydrogen phosphate (E341 (ii)), sodium stearyl fumarate.
English: The median number of prior anti-CLL treatments was 2 (range: 1 to 10 treatments); 49.5% with a prior nucleoside analogue, 38% with prior rituximab, and 94% with a prior alkylator (including 33% with prior bendamustine).
Maltese: L-għadd medjan ta' kuri kontra s-CLL qabel kien 2 (firxa: 1 sa 10 kuri); 49.5% b'analogu tannukleosidi, 38% b'rituximab minn qabel, u 94% b'sustanzi alkilanti minn qabel (inkluż 33% b'bendamustine minn qabel).
English: Also inhibitors of P-gp or BCRP may increase venetoclax exposure (see section 4.5).
Maltese: Ukoll inibituri ta' 7 P-gp jew BCRP jistgħu jżidu l-espożizzjoni venetoclax (ara sezzjoni 4.5).
English: Venclyxto film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blisters containing either 1, 2 or 4 film-coated tablets.
Maltese: Venclyxto pilloli huma fornuti f'kartuniet bil-folji tal-aluminju PVC/PE/PCTFE.
English: Table 4: Investigator-assessed progression-free survival in patients with previously treated CLL in MURANO
Maltese: Tabella 4: Sopravivenza mingħajr progressjoni evalwata mill-investigatur f'pazjenti b'CLL ittrattati minn qabel f'MURANO
English: Reduced renal function (CrCl <80 ml/min) further increases the risk.
Maltese: Tnaqqis fil-funzjoni tal-kliewi (CrCl <80 ml/min) ukoll iżid ir-riskju
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (5 day pack)
Maltese: KARTUNA (pakkett ta' 5 ijiem)
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).
Maltese: Fl-istudji ta' fażi 2 u fażi 1, 352 pazjent bis-CLL ittrattati minn qabel, li kien jinkludi 212 pazjent bi tneħħija ta' 17p u 146 pazjent li kienu fallew inibitur tal-passaġġ tar-riċettur taċ-ċellula B ġew ittrattati b'monoterapija ta' venetoclax (ara sezzjoni
English: Because venetoclax was not dosed to steady state, it is recommended that the international normalized ratio (INR) be monitored closely in patients receiving warfarin.
Maltese: Minħabba li venetoclax ma kienx iddożat għal stat fiss, huwa rrakkomandat li l-proporzjon normalizzat internazzjonali (INR, international normalized ratio) jiġi mmonitorjat mill-qrib f'pazjenti li jirċievu warfarin.
English: OS = overall survival; PFS = progression-free survival, PR = partial remission, TTR = time to first response.
Maltese: PFS = sopravivenza bla progressjoni, PR = remissjoni parzjali;
English: Median time since diagnosis was 6.7 years (range: 0.3 to 29.5).
Maltese: Ħin medjan mid-dijanjosi kien ta '6.7 snin (firxa: 0.3 sa 29.5).
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].
Maltese: F'analiżi ta' effikaċja aġġornata mal-pazjenti kollha li ma ġewx ittrattati (data ta' skadenza 8 ta' Mejju 2018 u medjan ta' follow-up ta' 36 xahar), l-istima PFS ta' 36 xahar fil-vina ta 'venetoclax + rituximab kienet 71.4% [95% CI: 64.8, 78.1] u fil-fergħa ta' bendamustine + rituximab kienet 15.
English: At the time of data cut-off (26 July 2017), 127 patients were enrolled and treated with venetoclax.
Maltese: Fiż-żmien tal-iskadenza tad-data (26 ta' Ġunju), 127 pazjent kienu rreġistrati u ttrattati b'venetoclax.
English: • a medicine for cancer known as everolimus
Maltese: • mediċina għall-kanċer magħrufa bħala everolimus
English: Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax (see section 4.5).
Maltese: Prodotti tal-grapefruit (tronġa), tal-larinġa tal-bakkaljaw, u tal-karambola għandhom jiġu evitati waqt it trattament b'venetoclax (ara sezzjoni 4.5).
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).
Maltese: L-użu konkomitanti ta' venetoclax b'inibituri ta' CYP3A qawwijin fil-bidu u waqt il-fażi tat-titrazzjoni tad doża huwa kontroindikat (ara sezzjonijiet 4.3, 4.4 u 4.5).
English: Reduced renal function (creatinine clearance [CrCl] <80 ml/min) further increases the risk.
Maltese: It-tnaqqis fil-funzjoni tal-kliewi (tneħħija tal-krejatinina [CrCl] <80 ml/min) aktar iżid ir-riskju.
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.
Maltese: Il-pazjenti fil-fergħa ta' Venclyxto + rituximab spiċċaw l-iskeda tad-doża ta' 5 ġimgħat ta' Venclyxto u mbagħad irċivew 400 mg darba kuljum għal 24 xahar micĊiklu 1 Jum 1 ta' rituximab fin-nuqqas ta' progressjoni tal-marda jew tossiċità inaċċettabbli.
English: All events were laboratory TLS
Maltese: TLS tal-laboratorju; 5
English: Venclyxto 100 mg tablets
Maltese: Venclyxto 100 mg pilloli
English: At baseline, 41% of patients had one or more nodes ≥5 cm and 31% had ALC ≥25 x 109/l.
Maltese: Fil-linja bażi, 41% tal-pazjenti kellhom nodula waħda jew aktar ≥5 cm, u 31% kellhom ALC ≥25 x 109/l.
English: • 10 tablets (5 blisters each with 2 tablets)
Maltese: • 10 pilloli (5 folji b'2 pilloli kull waħda)
English: Concomitant use of venetoclax with strong or moderate CYP3A4 inducers should be avoided (see sections 4.3 and 4.5).
Maltese: CYP3A4 qawwijin jew moderati, għandu jiġi evitat (ara sezzjonijiet 4.3 u 4.5).
English: Of the 107 patients who were evaluated for efficacy from M13-982 study, 57% were 65 years or older.
Maltese: Mill-107 pazjenti li ġew evalwati għall-effikaċja mill-istudju M13-982, 57% kienu ta' 65 sena jew akbar.
English: Blood creatinine increased aOnly the highest frequency observed in the trials is reported (based on studies MURANO, M13-982, M14032, and M12-175).
Maltese: Żieda tal-krejatinina fid-demm a L-ogħla frekwenza osservata biss fil-provi hija rrappurtata (ibbażata fuq studji MURANO, M13-982, M14-032, u
English: Venclyxto 50 mg film-coated tablet is beige, oblong 14 mm long, with V on one side and 50 on the other.
Maltese: Venclyxto pillola miksija b'rita ta' 50 mg hija beige, rettangolari twila 14 mm, b'V fuq naħa u 50 fuq in-naħa l-oħra.
English: Results of subgroup analyses
Maltese: Riżultati tal-analiżi tas-sottogrupp
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.
Maltese: Ħamsa u għoxrin fil-mija (32/127) tal-pazjenti kellhom MRD negattiv fid-demm periferali, inkluż 8 pazjenti li kienu MRD negattiv fil-mudullun ukoll.
English: Grade 3 neutropenia was reported in 32% of patients and grade 4 neutropenia in 26% of patients.
Maltese: In-newtropenija ta' Grad 3 kienet irrappurtata fi 32% tal-pazjenti u newtropenja ta' grad 4 f'26% tal-pazjenti.
English: Co administration with transporter substrates/inhibitors Venetoclax is a P-gp and BCRP substrate as well as a P-gp and BCRP inhibitor and a weak OATP1B1 inhibitor in vitro (see section 4.5).
Maltese: Venetoclax huwa sottostrat P-gp u BCRP kif ukoll inibitur P-gp u BCRP u inibitur dgħajjef OATP1B1 in vitro (ara sezzjoni 4.5).
English: Tumour lysis syndrome is an important identified risk when initiating venetoclax.
Maltese: Sindromu tal-lijasi tat-tumur Is-sindromu tal-lijasi tat-tumur huwa riskju identifikat importanti meta tibda venetoclax.
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.
Maltese: L-għoti flimkien ta' 50 mg darba kuljum ritonavir, CYP3A qawwi u inibitur P-gp, għal 14-il jum f'6 individwi b'saħħithom żied venetoclax Cmax b'2.4 drabi u AUC b'7.9 drabi.
English: Venetoclax in combination with rituximab for the treatment of patients with CLL who have received at least one prior therapy - study GO28667 (MURANO)
Maltese: Effikaċja klinika u sigurtà Venetoclax flimkien ma' rituximab għat-trattament ta' pazjenti bi CLL li rċivew mill-inqas terapija minn qabel - studju GO28667 (MURANO)
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.
Maltese: Sebgħa u għoxrin fil-mija (42/158) tal-pazjenti kellhom MRD negattiv fid-demm periferali, inkluż 16-il pazjent li kellhom MRD negattiv fil-mudullun.
English: The estimated PFS rate at 6 months post treatment was 92%.
Maltese: Ir-rata stmata ta' PFS wara 6 xhur wara t-trattament kienet ta' 92%.
English: Median follow-up time for primary analysis was 23.8 months (range: 0.0 to 37.4 months).
Maltese: Iżżmien medjan ta 'segwitu għall-analiżi primarja kien ta' 23.8 xhur (medda ta '0.0 sa 37.4 xhur).
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON Multipack (with blue box)
Maltese: KARTUNA - Pakkett multiplu -(b'kaxxa blu)
English: 28 film-coated tablets Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: Other medicines and Venclyxto
Maltese: Mediċini oħra u Venclyxto
English: Beige, oblong biconvex shaped tablet 14 mm long, 8 mm wide debossed with V on one side and 50 on the other.
Maltese: Pillola beige, rettangolari, imżaqqa miż-żewġ naħat twila 14 mm, wiesgħa 8 mm, li għandha V imnaqqxa fuq naħa u 50 fuq in-naħa l-oħra.
English: Kaplan-Meier curves of investigator-assessed PFS from the updated efficacy analysis are shown in Figure 1.
Maltese: Il-kurvi Kaplan-Meier tal-PFS evalwati mill-investigatur mill-analiżi aġġornata tal-effikaċja huma murija fil-Figura
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.
Maltese: Pillola safra ċara, rettangolari, imżaqqa miż-żewġ naħat, twila 17.2 mm, wiesgħa 9.5 mm li għandha V imnaqqxa fuq naħa u 100 fuq in-naħa l-oħra.
English: In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.
Maltese: Fl-istudji ta' monoterapija, l-iktar reazzjonijiet avversi komuni kienu kienu tnaqqis fl-għadd ta' newtropenija/newtrofili, dijarea, dardir, anemija, għeja u infezzjoni fin-naħa ta' fuq tal-apparat respiratorju.
English: Tumour lysis syndrome Hyperkalaemia Hyperphosphataemia Hypocalcaemia
Maltese: - mediċina li tintuża biex tittratta kundizzjoni fil-pulmun imsejħa ipertensjoni arterjali pulmonari bosentan
English: Based on population pharmacokinetic analysis, gastric acid reducing agents (e.g., proton pump inhibitors, H2-receptor antagonists, antacids) do not affect venetoclax bioavailability.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, is-sustanzi li jnaqqsu l-aċidu gastriku (eż. inibituri tal pompa tal-protoni, antagonisti tar-riċettur H2, antiaċidi) ma jaffetwawx il-bijdisponibbiltà ta' venetoclax.
English: Of the patients, 37% (34/91) were fludarabine refractory, 81% (30/37) harboured the unmutated IgVH gene, and 72% (60/83) had TP53 mutation.
Maltese: Mill-pazjenti, 37% (34/91) kienu refrattarji għal fludarabine, 81% (30/37) kellhom il-ġene mhux mutat
English: • you have liver problems as this may increase your risk for side effects.
Maltese: • għandek problemi tal-fwied minħabba li jistgħu jżidu r-riskju ta' effetti sekondarji.
English: • 14 tablets (7 blisters each with 2 tablets)
Maltese: • 14-il pillola (7 folji b'2 pilloli kull waħda)
English: Supportive measures including antimicrobials for any signs of infection should be considered.
Maltese: Għandhom jitqiesu miżuri ta' appoġġ inkluż antimikrobjali għal kwalunkwe sinjal ta' infezzjoni.
English: There were no overall differences in safety or efficacy observed between older and younger patients in the combination study with venetoclax + rituximab and the monotherapy studies.
Maltese: Ma kienx hemm differenzi ġenerali fis-sigurtà u fl-effikaċja osservati bejn pazjenti akbar u pazjenti iżgħar fl-istudju kkombinat ma' venetoclax + rituximab u l-istudji ta' monoterapija.
English: MURANO was a randomised, controlled trial in which 194 patients with previously treated CLL received venetoclax in combination with rituximab.
Maltese: MURANO kien prova randomizzata u kkontrollata li fiha 194 pazjent b'CLL ittrattati qabel irċivew venetoclax flimkien ma' rituximab.
English: Hyperuricaemia
Maltese: Iperfosfatemija
English: Venclyxto 50 mg tablets venetoclax
Maltese: Venclyxto 50 mg pilloli venetoclax
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.
Maltese: rituximab u 6.7% (2/30) fil-fergħa ta' bendamustine + rituximab nstabu li kienu MRD negattivi.
English: In a drug-drug interaction study in 12 healthy subjects, co-administration of 500 mg of azithromycin on the first day followed by 250 mg of azithromycin once daily for 4 days decreased venetoclax Cmax by 25% and AUC∞ by 35%.
Maltese: azithromycin fl-ewwel jum segwit minn 250 mg ta' azithromycin darba kuljum għal 4 ijiem naqqas venetoclax Cmax b'25 % u AUC∞ b'35 %.
English: Co-administration of CYP3A4 inducers may lead to decreased venetoclax exposure and consequently a risk for lack of efficacy.
Maltese: L-għoti flimkien tal-indutturi CYP3A4 jista' jwassal għal tnaqqis fl-esponiment ta' venetoclax u konsegwentement għal riskju ta' nuqqas ta' effikaċja.
English: • in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
Maltese: • fl-assenza ta' tneħħija ta' 17p jew ta' mutazzjoni TP53 f'pazjenti adulti li fallew kemm kimoimmunoterapija kif ukoll inibitur tar-riċettur taċ-ċellula B.
English: • the dose will be increased to 400 mg (four 100 mg tablets) once a day for 7 days.
Maltese: • id-doża ser tiżdied għal 400 mg (erba' pilloli ta' 100 mg) darba kuljum għal 7t ijiem.
English: Patients with reduced renal function (CrCl <80 ml/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase (see “Prevention of tumour lysis syndrome” above).
Maltese: (CrCl <80 ml/min) jistgħu jeħtieġu profilassi aktar intensiva u monitoraġġ sabiex inaqqsu r-riskju tat-TLS
English: Of the 296 patients evaluated for safety from 3 open-label monotherapy trials, 57% were 65 years or older.
Maltese: Mill-296 pazjent evalwati għas-sikurezza minn 3 provi monoterapija miftuħa, 57% kienu ta' 65 sena jew akbar.
English: In total, 130 patients in the venetoclax + rituximab arm completed 2 years of venetoclax treatment without progression.
Maltese: B'kollox, 130 pazjent fil-vina ta' venetoclax + rituximab spiċċaw 2 snin ta' trattament b'venetoclax mingħajr progressjoni.
English: You should continue to drink at least 1.5 to 2 litres of water on the day you start Venclyxto.
Maltese: Għandek tibda tixrob mill-anqas 1.5 sa 2 litri ta' ilma kuljum jumejn qabel ma tibda Venclyxto.
English: Venclyxto 10 mg tablets venetoclax
Maltese: Venclyxto 10 mg pilloli venetoclax
English: During dose-titration phase, treatment should be interrupted and patients should be monitored carefully for signs and symptoms of TLS (fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, muscle or joint pain, abdominal pain and distension) along with other toxicities (see section 4.2).
Maltese: Waqt il-fażi tat-titrazzjoni tad doża, it-trattament għandu jiġi interrott u l-pazjenti għandhom jiġu mmonitorjati bir-reqqa għal sinjali u sintomi tat-TLS (deni, tertir, dardir, rimettar, konfużjoni, qtugħ ta' nifs, aċċessjonijiet, taħbit tal-qalb irregolari, awrina skura jew imċajpra, għeja mhux tas-soltu, uġigħ fil-muskoli jew fil-ġogi, uġigħ addominali u nefħa) flimkien ma' tossiċitajiet oħrajn (ara sezzjoni 4.2).
English: • the dose will be increased to 200 mg (two 100 mg tablets) once a day for 7 days.
Maltese: • id-doża ser tiżdied għal 200 mg (żewġ pilloli ta' 100 mg) darba kuljum għal 7t ijiem.
English: Lymphopenia
Maltese: Ipokalċimja
English: Of the 127 patients who were evaluated for efficacy from M14-032 study, 58% were 65 years or older.
Maltese: Mill-127 pazjent li ġie evalwat għall-effikaċja mill-istudju M14-032, 58% kienu ta' 65 sena jew akbar.
English: - Keep this leaflet.
Maltese: Proporzjon ta 'periklu
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).
Maltese: posaconazole, voriconazole, clarithromycin, ritonavir,) fil-bidu u waqt il-fażi tat-titrazzjoni tad-doża huwa kontro-indikat minħabba ż-żieda fir-riskju tat-TLS (ara sezzjoni 4.3).
English: MRD negativity was defined as a result below 0.0001 (<1 CLL cell per 104 leukocytes in the sample).
Maltese: kienet definita bħala riżultat taħt 0.0001 (<1 ċellula tas-CLL għal kull 104 lewkoċiti fil-kampjun).
English: Based on venetoclax large volume of distribution and extensive protein binding, dialysis is unlikely to result in significant removal of venetoclax.
Maltese: venetoclax u irbit estensiv tal-proteina, huwa improbabbli li d-dijalisi tirriżulta fi tneħħija sinifikanti ta' venetoclax.
English: Venclyxto 100 mg tablets venetoclax
Maltese: Venclyxto 100 mg pilloli venetoclax
English: Dosage reductions due to adverse reactions occurred in 15% of patients treated with the combination of venetoclax and rituximab in the MURANO study and 14% of patients treated with venetoclax in the monotherapy studies.
Maltese: It-tnaqqis fid-doża minħabba reazzjonijiet avversi seħħ f'15% tal-pazjenti ttrattati b'taħlita ta' venetoclax u rituximab fl-istudju MURANO u 14% tal-pazjenti ttrattati b'venetoclax fl-istudji ta' monoterapija.
English: A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment (see section 5.2).
Maltese: Tnaqqis fid-doża ta' mill-inqas 50% matul it-trattament huwa rrakkomandat għal pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 5.2).
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.
Maltese: Venclyxto pillola miksija b'rita ta' 100 mg hija safra ċara, rettangolari twila 17.2 mm, b'V fuq naħa u 100 fuq in-naħa l-oħra.
English: Effects of age, sex, and weight
Maltese: Effetti fuq l-età, is-sess, u l-piż
English: Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets
Maltese: Venclyxto 10 mg pilloli miksijin b'rita Venclyxto 50 mg pilloli miksijin b'rita Venclyxto 100 mg pilloli miksijin b'rita
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)
Maltese: • Venclyxto 50 mg pilloli miksijin b'rita: iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b)
English: Not applicable.
Maltese: negattivi.
English: Of these, 91 patients had received prior ibrutinib therapy (Arm A) and 36 had received prior idelalisib therapy (Arm B).
Maltese: Minn dawn, 91 pazjent kienu rċevew terapija minn qabel b'ibrutinib (Fergħa A) u 36 kienu rċevew terapija minn qabel b'idelalisib (Fergħa B).
English: The instructions for “Prevention of tumour lysis syndrome” should be followed (see section 4.2).
Maltese: L-istruzzjonijiet għall-Prevenzjoni tas sindromu tal-lijasi tat-tumur għandhom jiġu segwiti (ara sezzjoni 4.2).
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.
Maltese: aId-diskrepanza bejn l-IRC u r-rata CR evalwata mill-investigatur kienet dovuta għall-interpretazzjoni ta' adenopatija residwa fuq sken CT. Tmintax-il pazjent fil-fergħa ta' venetoclax + rituximab u 3 pazjenti filfergħa ta' bendamustine + rituximab kellhom mudullun negattiv u lymph nodes <2 ċm.