FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: I et lægemiddelinteraktionsstudie hos tre raske forsøgspersoner resulterede samtidig administration af en enkelt dosis på 400 mg venetoclax sammen med 5 mg warfarin i en stigning i Cmax og AUC∞ for R-warfarin og S-warfarin på 18-28 %.
English: The median time since diagnosis was 6.8 years (range: 0.1 to 32 years; N=106).
Danish: Mediantiden efter diagnosen var 6,8 år (interval: 0,1-32 år; N = 106).
English: Median prior lines of therapy was 1 (range: 1 to 5); and included alkylating agents (94%), anti-CD20 antibodies (77%), B-cell receptor pathway inhibitors (2%) and prior purine analogs (81%, including 55% FCR).
Danish: Det mediane antal tidligere behandlinger var 1 (interval: 1-5); og inkluderede alkylerende stoffer (94%), anti-CD20 antistoffer (77%), B-celle receptor-hæmmere (2%) og tidligere behandling med purin-analoger (81%, inklusive 55% FCR).
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.
Danish: Indlægsseddel: Information til patienten Venclyxto 10 mg filmovertrukne tabletter Venclyxto 50 mg filmovertrukne tabletter Venclyxto 100 mg filmovertrukne tabletter venetoclax Dette lægemiddel er underlagt supplerende overvågning.
English: Hazard ratio (95% CI) P-valuea
Danish: Hazard-ratio (95% KI) P-værdia
English: - Women of childbearing age must use a highly effective method of contraception during treatment and for at least 30 days after receiving Venclyxto to avoid becoming pregnant.
Danish: - Kvinder, der kan få børn, skal bruge en sikker præventionsmetode under Venclyxto-behandlingen og i mindst 30 dage efter den sidste dosis for at undgå at blive gravide.
English: Patients should be instructed to drink plenty of water daily starting 2 days before and throughout the dose-titration phase.
Danish: Patienterne skal informeres om, at de skal drikke meget vand hver dag i hele dosistitreringsfasen, og at de skal starte med dette 2 dage før behandlingsstart.
English: Median time since diagnosis was 6.7 years (range: 0.3 to 29.5).
Danish: Mediantiden efter diagnosen var 6,7 år (interval: 0,3-29,5).
English: At initiation and during the dose-titration phase, concomitant use of venetoclax with moderate CYP3A inhibitors (e.g., ciprofloxacin, diltiazem, erythromycin, fluconazole, verapamil) should be avoided.
Danish: Ved behandlingsstart og i dosistitreringsfasen bør samtidig anvendelse af venetoclax og moderate CYP3Ahæmmere (f.eks.ciprofloxacin, diltiazem, erythromycin, fluconazol og verapamil) undgås.
English: Both effects were reversible after cessation of dosing with venetoclax, with recovery of lymphocytes occurring 18 weeks post treatment.
Danish: Den toksiske virkning på såvel lymfocytter som røde blodlegemer var reversibel efter seponering af venetoclax, idet lymfocytterne var gendannet 18 uger efter behandlingen.
English: If a patient vomits following dosing, no additional dose should be taken that day.
Danish: Hvis en patient kaster op efter at have taget sin dosis, må han/hun ikke tage en ekstra dosis den dag.
English: The most frequently reported serious adverse reactions (≥2%) in patients receiving venetoclax in combination with rituximab were pneumonia, febrile neutropenia, and TLS.
Danish: De hyppigst rapporterede alvorlige bivirkninger (≥ 2 %) hos patienter, som fik venetoclax i kombination med rituximab var pneumoni, febril neutropeni og tumorlysesyndrom.
English: Patients with moderate hepatic impairment should be monitored more closely for signs of toxicity at initiation and during the dose-titration phase (see section 4.8).
Danish: Patienter med moderat nedsat leverfunktion skal monitoreres meget nøje for tegn på toksicitet ved behandlingsstart og i dosistitreringsfasen (se pkt.
English: Venetoclax as monotherapy for the treatment of patients with CLL harbouring 17p deletion or TP53 mutation - study M13-982
Danish: Venetoclax som monoterapi til behandling af patienter, der har kronisk lymfatisk leukæmi med 17p-deletion eller TP53-mutation - studie M13-982
English: Also inhibitors of P-gp or BCRP may increase venetoclax exposure (see section 4.5).
Danish: Hæmmere af P-gp eller BCRP kan også øge venetoclax-eksponeringen.
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.
Danish: I et dedikeret studie hos patienter med nedsat leverfunktion var venetoclax Cmax og AUC hos forsøgspersoner med let (Child-Pugh A; n = 6) eller moderat nedsat leverfunktion (Child-Pugh B; n = 6) den samme som hos forsøgspersoner med normal leverfunktion efter indtagelse af 50 mg enkeltdosis venetoclax.
English: For patients who are on a steady daily dose of Venclyxto, the venetoclax dose should be reduced by 50% when used concomitantly with moderate CYP3A inhibitors and by 75% when used concomitantly with strong CYP3A inhibitors.
Danish: Hos patienter i Venclyxto-behandling, der er på en stabil daglig dosis, skal venetoclax-dosis reduceres med 50 % ved samtidig behandling med moderate CYP3A-hæmmere og med 75 % ved samtidig behandling med potente CYP3A-hæmmere.
English: At baseline, 41% of patients had one or more nodes ≥5 cm and 31% had ALC ≥25 x 109/l.
Danish: Ved baseline havde 41 % af patienterne én eller flere lymfeknuder ≥ 5 cm, og 31 % havde ALC ≥ 25 x 109/l.
English: If you forget to take Venclyxto
Danish: Hvis du har glemt at tage Venclyxto
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).
Danish: Det mediane antal tidligere behandlinger for kronisk lymfatisk leukæmi var 2 (interval: 1-10 behandlinger), 49,5 % var tidligere blevet behandlet med en nukleosidanalog, 38 % med rituximab og 94 % med et alkylerende middel (hvoraf 33 % tidligere var blevet behandlet med bendamustin).
English: If you are not sure about this, talk to your doctor, pharmacist or nurse before taking Venclyxto.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager Venclyxto.
English: • lower level of calcium
Danish: • nedsat calcium
English: Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Danish: systemorganklasse og hyppighed.
English: Patients randomised to BR received bendamustine at 70 mg/m2 on Days 1 and 2
Danish: Patienterne, som blev randomiseret til BR, fik bendamustin 70 mg/m2 på dag 1 og 2 i 6 cykler og rituximab,
English: In vitro studies demonstrated that venetoclax is predominantly metabolised by cytochrome P450 CYP3A4.
Danish: In vitro-studier har vist, at venetoclax hovedsagelig metaboliseres via CYP3A4.
English: Concomitant use of venetoclax with strong CYP3A inducers (e.g., carbamazepine, phenytoin, rifampin) or moderate CYP3A inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) should be avoided.
Danish: Samtidig anvendelse af venetoclax og potente CYP3A-induktorer (f.eks. carbamazepin, phenytoin og rifampicin) eller moderate CYP3Ainduktorer (f.eks. bosentan, efavirenz, etravirin, modafinil og nafcillin) bør undgås.
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%).
Danish: I MURANO-studiet forekom doseringsafbrydelse på grund af bivirkninger hos 71% af patienterne behandlet med kombinationen af venetoclax og rituximab: den mest almindelige bivirkning, som førte til afbrydelse af venetoclax-dosis, var neutropeni (43%).
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON Multipack (with blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske - Multipakning (med blue box)
English: Co-administration of narrow therapeutic index P-gp, or BCRP substrates (e.g., digoxin, dabigatran, everolimus, sirolimus) with venetoclax should be avoided.
Danish: Samtidig administration af venetoclax og P-gp eller BCRP-substrater med snævert terapeutisk indeks (f.eks. digoxin, dabigatran, everolimus, sirolimus) børundgås.
English: Colloidal anhydrous silica (E551) Polysorbate 80 (E433)
Danish: Silica, kolloid vandfri (E551) Polysorbat 80 (E433)
English: P-gp and BCRP inhibitors
Danish: P-gp- og BCRP-hæmmere
English: • In the tablet core: copovidone (K 28), polysorbate 80 (E433), colloidal anhydrous silica (E551),
Danish: • Tabletkernen: copovidon (K 28), polysorbat 80 (E433), silica, kolloid vandfri (E551),
English: These patients should be monitored more closely for signs of toxicity (see section 4.8).
Danish: Disse patienter bør overvåges nøje for tegn på toksicitet (se pkt.
English: 12-month PFS estimate (95% CI)
Danish: 12-måneders PFS estimat (95% KI)
English: Prior to initiating venetoclax, tumour burden assessment, including radiographic evaluation (e.g., CT scan), must be performed for all patients.
Danish: Tumorbyrden skal vurderes hos alle patienter inden påbegyndelse af venetoclax-behandling, herunder radiografisk undersøgelse (f.eks. CT-scanning).
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
Danish: rifampicin - lægemider til forebyggelse af krampeanfald og behandling af epilepsi - carbamazepin, phenytoin - lægemidler til behandling af hiv-infektion - efavirenz, etravirin, ritonavir - lægemidler til behandling af forhøjet blodtryk eller hjertekrampe (angina pectoris) - diltiazem,verapamil - lægemidler, der bruges til at sænke indholdet af kolesterol i blodet - colestyramin, colestipol,
English: Venetoclax as monotherapy for the treatment of patients with CLL who have failed a B-cell receptor pathway inhibitor - study M14-032
Danish: Venetoclax som monoterapi til behandling af CLL-patienter, der har oplevet behandlingssvigt af en B-cellereceptor-hæmmer - studie M14-032
English: Other medicines and Venclyxto
Danish: Brug af anden medicin sammen med Venclyxto
English: Concomitant use of venetoclax with moderate CYP3A inhibitors at initiation and during the dose-titration phase should be avoided.
Danish: Samtidig brug af venetoclax og moderate CYP3A-hæmmere bør undgås ved behandlingsstart og i dosistitreringsfasen.
English: Agents that may alter venetoclax plasma concentrations
Danish: Stoffer, der kan ændre plasmakoncentrationen af venetoclax
English: Sepsis Urinary tract infection
Danish: Almindelig Sepsis Urinvejsinfektion
English: Your doctor may change your dose of Venclyxto.
Danish: Det kan være nødvendigt, at lægen ændrer din Venclyxto-dosis.
English: anydrous calcium hydrogen phosphate (E341 (ii)), sodium stearyl fumarate.
Danish: calciumhydrogenfosfat, vandfrit (E341 (ii)), natriumstearylfumarat.
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.
Danish: Alle tilfælde af tumorlysesyndrom blev identificeret ud fra laboratorieværdier (unormale værdier, der opfyldte ≥ 2 af følgende kriterier inden for et indbyrdes interval på 24 timer: kalium > 6 mmol/l, urinsyre > 476 µmol/l, calcium < 1,75 mmol/l eller phosphat > 1,5 mmol/l, eller som blev rapporteret som tilfælde af tumorlysesyndrom) og sås hos patienter, der havde en eller flere lymfeknuder ≥ 5 cm eller ALC ≥ 25 x 109/l.
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%.
Danish: Samtidig administration af en enkeltdosis på 600 mg rifampicin, en P-gp-hæmmer, hos 11 raske forsøgspersoner øgede venetoclax-Cmax 106 % og -AUC∞ 78 %.
English: Women of childbearing potential/Contraception in females Women should avoid becoming pregnant while taking Venclyxto and for at least 30 days after ending treatment.
Danish: Kvinder skal undgå at blive gravide, mens de tager Venclyxto og i mindst 30 dage efter behandlingens afslutning.
English: The median age was 66 years (range: 28 to 85 years), 70% were male, and 92% were white.
Danish: Medianalderen var 66 år (interval: 28-85 år), 70 % var mænd, og 92 % var hvide.
English: A dose reduction of at least 50% throughout treatment is recommended for patients with severe hepatic impairment (see section 5.2).
Danish: Hos patienter med alvorlig nedsat leverfunktion anbefales en dosisreduktion på mindst 50 % (se pkt.
English: How to take Venclyxto 4.
Danish: Sådan skal du tage Venclyxto 4.
English: Tumour lysis syndrome is an important identified risk when initiating venetoclax.
Danish: Tumorlysesyndrom er en væsentlig risiko i forbindelse med behandlingsstart af venetoclax.
English: Anhydrous calcium hydrogen phosphate (E341 (ii))
Danish: Calciumhydrogenphosphat, vandfrit (E341 (ii))
English: Venclyxto should not be used in children and adolescents.
Danish: Venclyxto bør ikke anvendes til børn og unge, da lægemidlet ikke er undersøgt hos disse aldersgrupper.
English: In the monotherapy studies with venetoclax, dose interruptions due to adverse reactions occurred in 40% of patients; the most common adverse reaction leading to dose interruption was neutropenia (5%).
Danish: I monoterapi-studierne med venetoclax, forekom doseringsafbrydelse på grund af bivirkninger i 40% af patienterne; neutropeni (5%) var den mest almindelige bivirkning, som førte til doseringsafbrydelse.
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.
Danish: d76,9% (30/39) i venetoclax + rituximab-armen og 6,7% (2/30) i bendamustin + rituximab-armen af dem med tilgængelige MRD-testresultater i knoglemarv, viste sig at være MRD-negative.
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).
Danish: Mere intensiv profylakse og monitorering ved behandlingsstart og i dosistitreringsfasen kan være nødvendig hos patienter med nedsat nyrefunktion (CrCl < 80 ml/min) for at mindske risikoen for tumorlysesyndrom (se afsnittet "Forebyggelse af tumorlysesyndrom" ovenfor).
English: Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax (see section 4.5).
Danish: Grapefrugt/grapefrugtjuice, pomerans og stjernefrugt (carambole) skal undgås under behandling med venetoclax (se pkt.
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.
Danish: c72,5% (121/167) i venetoclax + rituximab-armen og 20% (26/128) i bendamustin + rituximab-armen af dem med tilgængelige MRD-testresultater i det perifere blod, viste sig at være MRD-negative.
English: If a narrow therapeutic index P-gp or BCRP substrate must be used, it should be used with caution.
Danish: Der skal udvises forsigtighed, hvis samtidig behandling med et P-gp- eller BCRP-substrat med snævert terapeutisk indeks er nødvendig.
English: If a patient misses a dose by more than 8 hours, the patient should not take the missed dose and should resume the usual dosing schedule the following day.
Danish: Hvis en patient har glemt at tage en dosis, og der er gået over 8 timer, må han/hun ikke tage den manglende dosis, men skal vente til næste dags dosis.
English: ORR, % (95% CI)
Danish: ORR, % (95 % KI)
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).
Danish: Den venetoclax-dosis, som patienten fik inden initiering af CYP3Ahæmmeren, skal genoptages 2-3 dage efter seponering af CYP3A-hæmmeren (se pkt.
English: Ask your doctor for advice on sperm storage before starting treatment with Venclyxto.
Danish: Spørg lægen til råds, før du begynder at tage Venclyxto.
English: Median age was 65 years (range: 22 to 85); 74% were male, and 97% were white.
Danish: Medianalderen var 65 år (interval: 22-85); 74% var mænd og 97% var hvide.
English: Venetoclax is a P-gp, BCRP and OATP1B1 inhibitor in vitro.
Danish: Venetoclax hæmmer P-gp, BCRP og OATP1B1 in vitro.
English: If a patient misses a dose of venetoclax within 8 hours of the time it is usually taken, the patient should take the missed dose as soon as possible on the same day.
Danish: Hvis en patient har glemt at tage en dosis venetoclax, og der er gået mindre end 8 timer, siden dosis skulle have været taget, skal han/hun tage den manglende dosis med det samme (samme dag).
English: The median age was 67 years (range: 37 to 85 years); 65% were male, and 97% were white.
Danish: Medianalderen var 67 år (interval: 37-85 år), 65 % var mænd, og 97 % var hvide.
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.
Danish: Seponering og dosisreduktion på grund af bivirkninger I MURANO-studiet forekom seponering på grund af bivirkninger hos 16% af patienterne behandlet med kombinationen af venetoclax og rituximab.
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.
Danish: KI = konfidensinterval; CR = komplet remission; CRi = komplet remission med ufuldstændig knoglemarvsregeneration; DOR = responsvarighed; nPR = nodulær PR; NR = Ikke opnået; ORR= den samlede responsrate, OS= samlet overlevelse; PFS= progressionsfri overlevelse , PR = partiel remission; TTR= tid til første respons.
English: Table 6: Efficacy results in patients with previously treated CLL with 17p deletion (study M13-982) Endpoint
Danish: Tabel 6: Effektresultater hos patienter med 17p-deletion, der tidligere er behandlet for kronisk lymfatisk leukæmi (studie M13-982)
English: Venetoclax daily dose
Danish: Daglig dosis af venetoclax
English: Patients should be assessed for risk and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricaemics.
Danish: Patienterne skal risikovurderes og have relevant profylakse mod tumorlysesyndrom,
English: • the starting dose is 20 mg (two 10 mg tablets) once a day for 7 days.
Danish: • startdosis er 20 mg (to 10 mg-tabletter) én gang dagligt i 7 dage.
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.
Danish: I MURANO-studiet blev dosis reduceret på grund af bivirkninger hos 15 % af patienterne, som blev behandlet med kombinationen af venetoclax og rituximab og hos 14 % af patienterne behandlet med venetoclax i monoterapi-studierne.
English: Hyperkalaemia Hyperphosphataemia Hypocalcaemia
Danish: Hyperfosfatæmi Hyperkaliæmi Hypokalcæmi
English: • 5 tablets (5 blisters each with 1 tablet)
Danish: • 5 tabletter (5 blisterkort hver med 1 tablet)
English: 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.
Danish: Steady state-AUC for venetoclax steg proportionalt med dosis i intervallet 150-800 mg. Ved indtagelse af 400 mg venetoclax én gang dagligt sammen med et fedtfattigt måltid var den gennemsnitlige steady stateCmax (± standardafvigelse) 2,1 ± 1,1 μg/ml, og AUC24 var 32,8 ± 16,9 μg•time/ml.
English: Tumour lysis syndrome Hyperkalaemia Hyperphosphataemia Hypocalcaemia
Danish: Tumorlysesyndrom Hyperkaliæmi Hyperfosfatæmi Hypokalcæmi
English: What Venclyxto is used for
Danish: Hvad bruges Venclyxto til?
English: Тел:+359 2 90 30 430
Danish: АбВи ЕООД Тел: +359 2 90 30 430
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%.
Danish: Samtidig administration af rifampicin, en potent CYP3A-induktor, 600 mg én gang dagligt i 13 dage hos 10 raske forsøgspersoner nedsatte venetoclax-Cmax 42 % og -AUC∞ 71 %.
English: Response rate ORR, % (95% CI)
Danish: Responsrate ORR, % (95% KI)
English: Median, months (95% CI)
Danish: Median, måneder (95% KI)
English: Based on embryo-foetal toxicity studies in animals (see section 5.3), venetoclax may harm the foetus when administered to pregnant women.
Danish: 5.3) kan venetoclax skade fosteret, hvis det gives til gravide kvinder.
English: for 6 cycles and rituximab as described above.
Danish: som beskrevet ovenfor.
English: • higher level of urea
Danish: • forhøjet urinstof
English: PARTICULARS TO APPEAR ON THE OUTER CARTON CARTON (7 day pack)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske (7-dages pakning)
English: Table 7: Efficacy results as assessed by investigator in patients who have failed a B-cell receptor pathway inhibitor (study M14-032)
Danish: Tabel 7: Effektresultater i henhold til investigators vurdering hos patienter, der havde oplevet behandlingssvigt af en B-celle-receptor-hæmmer (studie M14-032) Gruppe A (behandlingssvigt ved ibrutinib) (N = 91)
English: Patients should be monitored more closely for signs and symptoms of TLS.
Danish: Patienterne skal monitoreres meget nøje for symptomer på tumorlysesyndrom.
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).
Danish: Samtidig brug af dette lægemiddel og potente eller moderate CYP3A-hæmmere øger venetoclaxeksponeringen og kan øge risikoen for tumorlysesyndrom ved behandlingsstart og i dosistitreringsfasen (se pkt.
English: AbbVie SA Tél/Tel: +32 10 477811
Danish: Tél/Tel: +32 10 477811
English: It belongs to a group of medicines called “BCL-2 inhibitors”.
Danish: Det indeholder det aktive stof venetoclax og tilhører en gruppe lægemidler, der kaldes "BCL-2-hæmmere".
English: Venclyxto is a cancer medicine that contains the active substance venetoclax.
Danish: Venclyxto er et lægemiddel til behandling af kræft.
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.
Danish: Samtidig administration af 50 mg ritonavir, en stærk CYP3A- og P-gp-hæmmer, en gang dagligt i 14 dage hos 6 raske forsøgspersoner forhøjede venetoclax Cmax med 2,4-gange og AUC med 7,9-gange.
English: Diarrhoea Vomiting Nausea Constipation
Danish: Diarré Opkastning Kvalme Obstipation
English: In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions.
Danish: 11 % af patienterne i monoterapi-studierne med venetoclax seponerede på grund af bivirkninger.