FrancophonIA/ELRC3.0 huggingface dataset:
English: M27 was identified as a major metabolite in plasma with an inhibitory activity against BCL-2 that is at least 58-fold lower than venetoclax in vitro.
Danish: M27 blev identificeret som en hovedmetabolit i plasma med en hæmmende aktivitet på BCL-2, der er mindst 58 gange mindre end venetoclax' in vitro.
English: Of the 194 patients with previously treated CLL who received venetoclax in combination with rituximab, 50% were 65 years or older.
Danish: Af 194 patienter med tidligere behandlet CLL, som fik venetoclax i kombination med rituximab, var 50% 65 år eller ældre.
English: Venetoclax should be taken for 24 months from Cycle 1 Day 1 of rituximab (see section 5.1).
Danish: Venetoclax bør tages i 24 måneder fra 1. dag i 1. rituximab-cyklus (se pkt.
English: Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumour cell survival and has been associated with resistance to chemotherapeutics.
Danish: Overekspression af BCL-2 er påvist i CLL-celler, hvor det medierer tumorcellernes overlevelse og er blevet forbundet med resistens over for kemoterapeutika.
English: The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg as shown in Table 1.
Danish: Dosis skal øges gradvist over en periode på 5 uger til den daglige dosis på 400 mg, jf. tabel 1.
English: Carcinogenicity studies have not been conducted with venetoclax.
Danish: Der er ikke udført karcinogenicitetsstudier med venetoclax.
English: After 77/389 patients were enrolled in the study, the protocol was amended to incorporate the current TLS prophylaxis and monitoring measures described in Posology (see section 4.2).
Danish: Efter 77/389 patienter var indrulleret i studiet, blev protokollen ændret til at indeholde den nuværende TLS profylakse og de monitoreringsforanstaltninger beskrevet i Dosering (se pkt.
English: Drinking plenty of water, at least 1.5 to 2 litres per day, helps to remove cancer cell breakdown products from your body through urine, and may decrease your risk of getting TLS (see section 3).
Danish: Ved at drikke masser af vand, mindst 1,5 til 2 liter hver dag, kan du hjælpe din krop med at udskille kræftcellernes nedbrydningsprodukter i urinen og mindske din risiko for at få tumorlysesyndrom (se punkt 3).
English: • dark or cloudy urine
Danish: • mørk eller grumset urin
English: The primary efficacy endpoint was ORR according to IWCLL updated NCI-WG guidelines.
Danish: Det primære effektmål var ORR i henhold til IWCLL-opdaterede NCI-WG-retningslinjer.
English: It is recommended that venetoclax should be administered with a meal (see section 4.2).
Danish: Det anbefales, at venetoclax administreres i forbindelse med et måltid (se pkt.
English: Venetoclax can cause rapid reduction in tumour, and thus poses a risk for TLS in the initial 5-week dose-titration phase.
Danish: Venetoclax kan medføre hurtig tumorreduktion og indebærer dermed en risiko for tumorlysesyndrom i den indledende 5-ugers dosistitreringsfase.
English: Table 1: Dose increase schedule
Danish: Tabel 1: Doseringsplan
English: If a statin (OATP substrate) is used concomitantly with venetoclax, close monitoring of statin-related toxicity is recommended.
Danish: Hvis et statin (OATP-substrat) anvendes sammen med venetoclax, anbefales tæt monitorering for statinrelaterede bivirkninger.
English: This may lead to changes in kidney function, abnormal heartbeat, or seizures.
Danish: Det kan medføre ændringer i nyrefunktionen, uregelmæssig hjerterytme eller krampeanfald.
English: Safety in patients with severe renal impairment (CrCl <30 ml/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined.
Danish: Sikkerheden hos patienter med svært nedsat nyrefunktion (CrCl < 30 ml/min) og patienter i dialyse er ikke klarlagt, og en anbefalet dosis til disse patienter er ikke fastlagt.
English: When resuming treatment after interruption due to TLS, the instructions for prevention of TLS should be followed (see “Prevention of tumour lysis syndrome” above).
Danish: Når behandlingen genoptages efter afbrydelse på grund af tumorlysesyndrom, skal anvisningerne for forebyggelse af TLS følges (se "Forebyggelse af tumorlysesyndrom" ovenfor).
English: Venclyxto is used to treat patients with chronic lymphocytic leukaemia (CLL) when the disease has come back or has not responded to other treatment.
Danish: Venclyxto bruges til behandling af patienter med kronisk lymfatisk leukæmi (CLL), når sygdommen kommer tilbage eller ikke har reageret på anden behandling.
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.
Danish: Der var ingen generelle forskelle i sikkerhed eller virkning mellem ældre og yngre patienter i kombinationsstudiet med venetoclax + rituximab og monoterapi-studierne.
English: Dose at interruption (mg)
Danish: Dosis ved afbrydelse (mg)
English: One patient (ibrutinib failure) achieved complete remission with incomplete marrow recovery.
Danish: Én patient (der havde oplevet behandlingssvigt ved ibrutinib) opnåede komplet remission med ufuldstændig knoglemarvsregeneration.
English: There is no specific antidote for venetoclax.
Danish: Der er ingen specifik antidot til venetoclax.
English: There is no information about the safety of venetoclax in pregnant women.
Danish: Der foreligger ingen data om sikkerheden ved venetoclax hos gravide kvinder.
English: Take the next dose at the usual time the next day.
Danish: Tag den næste dosis på det sædvanlige tidspunkt næste dag.
English: The efficacy data were further evaluated by an IRC demonstrating a combined ORR of 70% (Arm A: 70%;
Danish: Effektdataene blev yderligere vurderet af en uafhængig review-komité (IRC), og de viste en samlet responsrate (ORR) på 70 % (gruppe A: 70 %, gruppe B: 69 %).
English: • If it is less than 8 hours since the time you usually take your dose, take it as soon as possible.
Danish: • Hvis der er gået mindre end 8 timer, siden du skulle have taget din dosis, skal du tage den så hurtigt som muligt.
English: Your doctor, pharmacist or nurse will do blood tests to check for TLS.
Danish: Lægen, apotekspersonalet eller sundhedspersonalet vil tage blodprøver for at tjekke dig for tumorlysesyndrom.
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).
Danish: Venetoclax har en høj bindingsgrad til humant plasmaprotein med en ubundet plasmafraktion på < 0,01 inden for et koncentrationsområde på 1-30 µM (0,87-26 µg/ml).
English: Grade 3 neutropenia was reported in 32% of patients and grade 4 neutropenia in 26% of patients.
Danish: Der blev rapporteret grad 3 neutropeni hos 32% af patienterne og grad 4 neutropeni hos 26% af patienterne.
English: Venclyxto has no or negligible influence on the ability to drive and use machines.
Danish: Venclyxto påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Laboratory assessments
Danish: Laboratorieanalyser
English: Film-coated tablet Multipack: 112 (4 x 28) film-coated tablets
Danish: Filmovertrukne tabletter Multipakning: 112 (4 x 28) filmovertrukne tabletter
English: Bone marrow, % (95% CI)d 15.5(10.7, 21.3)
Danish: Knoglemarv, % (95% KI)d 15,5 (10,7; 21,3)
English: Before starting treatment, counselling on sperm storage may be considered in some male patients.
Danish: Inden behandlingsstart bør individuel rådgivning om opbevaring af sæd overvejes.
English: No dose adjustment is needed during short-term use of azithromycin when administered concomitantly with venetoclax.
Danish: Dosisjustering er ikke nødvendig ved korttids brug af azithromycin, når det administreres sammen med venetoclax.
English: When your Venclyxto dose has been increased to the full standard dose, check with your doctor if you can start taking these medicines again.
Danish: Når du er nået op på fuld standarddosis af Venclyxto, skal du rådføre dig med din læge, om du må begynde at tage disse lægemidler igen.
English: Blood chemistry (potassium, uric acid, phosphorus, calcium, and creatinine) should be assessed and pre-existing abnormalities corrected.
Danish: Blodprøveranalyser (kalium, urinsyre, phosphat, calcium og kreatinin) skal udføres og eksisterende abnormiteter korrigeres.
English: Venetoclax is a substrate for P-gp and BCRP.
Danish: Venetoclax er substrat for P-gp og BCRP.
English: After approximately 3 months of daily dosing in dogs, venetoclax caused progressive white discoloration of the hair coat, due to loss of melanin pigment in the hair.
Danish: Hos hunde medførte daglig dosering af venetoclax efter ca. 3 måneder progredierende hvid misfarvning af pelsen på grund af tab af melanin.
English: Venclyxto monotherapy is indicated for the treatment of CLL:
Danish: Venclyxto-monoterapi er indiceret til behandling af CLL:
English: The median duration of grade 3 or 4 neutropenia was 8 days (range: 1-712 days).
Danish: Den gennemsnitlige varighed af grad 3 og 4 neutropeni var 8 dage (interval: 1-712 dage).
English: The effect of multiple doses of venetoclax up to 1200 mg once daily on the QTc interval was evaluated in an open-label, single-arm study in 176 patients.
Danish: Virkningen af multiple venetoclax-doser på op til 1.200 mg én gang dagligt på QTc-intervaller blev vurderet i et åbent enkeltgruppestudie med 176 patienter.
English: No human data on the effect of venetoclax on fertility are available.
Danish: Der foreligger ingen humane data om venetoclax' indvirkning på fertilitet.
English: Once the toxicity has resolved to grade 1 or baseline level (recovery), therapy with venetoclax may be restarted at the same dose.
Danish: Når toksiciteten er bedret til grad 1 eller baseline-niveau (restitution), kan venetoclax-behandlingen genoptages med samme dosis.
English: If you vomit after taking Venclyxto, do not take an extra dose that day.
Danish: Hvis du kaster op, efter at du har taget Venclyxto, må du ikke tage en ekstra dosis samme dag.
English: If you are using hormonal contraceptive pills or devices, you must also use a barrier method of contraception (such as condoms) as the effect of hormonal contraceptive pills or devices may be affected by Venclyxto.
Danish: Hvis du bruger p-piller eller andre former for hormonel prævention, skal du også anvende en barrieremetode (f.eks. kondom), da Venclyxto kan påvirke effektiviteten af hormonelle præventionsmidler.
English: Blood creatinine increased aOnly the highest frequency observed in the trials is reported (based on studies MURANO, M13-982, M14032, and M12-175).
Danish: Forhøjet kreatinin i blodet aKun den højest observerede hyppighed i studierne er rapporteret (baseret på studierne MURANO, M13982, M14-032 og M12-175).
English: Prevention of tumour lysis syndrome (TLS)
Danish: Forebyggelse af tumorlysesyndrom (TLS)
English: Your doctor will gradually increase the dose over the next 4 weeks to the full standard dose.
Danish: Derefter vil lægen gradvist øge dosis i løbet af de efterfølgende 4 uger, indtil du er nået op på fuld standarddosis.
English: Venetoclax is not recommended during pregnancy and in women of childbearing potential not using highly effective contraception.
Danish: Venetoclax bør ikke anvendes under graviditet og hos fertile kvinder, der ikke anvender meget effektiv prævention.
English: Restart dose (mga)
Danish: Dosis ved genoptagelse (mga)
English: The next prescribed dose should be taken at the usual time the following day.
Danish: Den næste planlagte dosis skal tages til sædvanlig tid dagen efter.
English: Patients received venetoclax via a recommended dose-titration schedule.
Danish: Patienterne fik venetoclax i henhold til en anbefalet dosistitreringsplan.
English: The population estimate for the terminal phase elimination half-life of venetoclax was approximately 26 hours.
Danish: I en farmakokinetisk populationsanalyse blev den terminale eliminationshalveringstid for venetoclax estimeret til ca. 26 timer.
English: Venclyxto film-coated tablets are for oral use.
Danish: Venclyxto filmovertrukne tabletter er til oral anvendelse.
English: IRC assessment (N=107)a
Danish: Vurdering af uafhængig review-komité (N = 107)a
English: Table 4: Investigator-assessed progression-free survival in patients with previously treated CLL in MURANO
Danish: Tabel 4: Investigators vurdering af progressionsfri overlevelse hos patienter med tidligere behandlet CLL i MURANO
English: Your doctor may need to stop certain medicines when you first start taking Venclyxto and during the first five weeks when your dose is gradually increased to the full standard dose.
Danish: Lægen vil måske sige til dig, at du skal ophøre med noget af din anden medicin, når du starter Venclyxto-behandlingen og i de første fem uger, hvor din dosis gradvist øges til fuld standarddosis.
English: If resolved within 24 to 48 hours of last dose, treatment with venetoclax can be resumed at the same dose.
Danish: Hvis symptomerne fortager sig inden for 24-48 timer efter den seneste dosis, kan venetoclax-behandlingen genoptages med samme dosis.
English: No clinical TLS was observed in patients who followed the current 5-week dose-titration schedule and TLS prophylaxis and monitoring measures (see section 4.2).
Danish: Der blev ikke observeret nogen klinisk TLS hos patienter, som fulgte den nuværende 5-ugers dosistitreringsplan og TLS profylakse og monitoreringsforanstaltninger (se pkt.
English: • a medicine used to prevent organ rejection known as sirolimus
Danish: • et lægemiddel, der bruges til at forebygge afstødning af et organ efter en transplantation - sirolimus
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:
Danish: Tumorlysesyndrom (almindelig bivirkning - kan forekomme hos op til 1 ud af 10 personer) Stop med at tage Venclyxto og søg læge med det samme, hvis du får symptomer på tumorlysesyndrom:
English: • medicines that prevent blood clots, warfarin, dabigatran
Danish: • blodfortyndende lægemidler - warfarin eller dabigatran
English: Your dose may need to be adjusted for side effects.
Danish: Det kan være nødvendigt at ændre din dosis, hvis du får bivirkninger.
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.
Danish: Atten patienter i venetoclax + rituximab-armen og 3 patienter i bendamustin + rituximab-armen havde negativ knoglemarv og lymfeknuder <2 cm. bMinimal residual sygdom blev vurderet ved brug af allel-specifik oligonukleotid polymerase kædereaktion (ASO-PCR) og/eller flowcytometri.
English: Based on testicular toxicity in dogs at clinically relevant exposures, male fertility may be compromised by treatment with venetoclax (see section 5.3).
Danish: Baseret på testikulær toksicitet hos hunde ved klinisk relevante eksponeringer, kan den mandlige fertilitet forringes ved behandling med venetoclax (se pkt.
English: Patients should be monitored more closely for signs of toxicities and the dose may need to be further adjusted.
Danish: Patienterne skal monitoreres meget nøje for tegn på toksicitet, og yderligere dosisjustering kan være nødvendig.
English: Venetoclax also caused single cell necrosis in various tissues, including the gallbladder and exocrine pancreas, with no evidence of disruption of tissue integrity or organ dysfunction; these findings were minimal to mild in magnitude.
Danish: Venetoclax forårsagede også enkeltcellenekrose i forskellige væv, herunder galdeblære og eksokrin pancreas, uden tegn på vævsødelæggelse eller påvirket organfunktion; sværhedsgraden af disse fund var minimal til let.
English: Alternative treatments with less CYP3A induction should be considered.
Danish: Andre lægemidler med mindre CYP3A-inducerende effekt bør overvejes.
English: No specific dose adjustment is required for elderly patients (aged ≥65 years) (see section 5.1).
Danish: Ældre Specifik dosisjustering er ikke nødvendig hos ældre patienter (≥ 65 år ) (se pkt.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, apotekspersonalet eller sundhedspersonalet til råds, før du tager dette lægemiddel.
English: Patients followed a 4- to 5-week dose-titration schedule starting at 20 mg and increasing to 50 mg, 100 mg, 200 mg and finally 400 mg once daily.
Danish: Patienterne fulgte en 4-5 ugers titreringsplan med en initialdosis på 20 mg og stigning til 50 mg, 100 mg, 200 mg og endelig 400 mg én gang dagligt.
English: The overall safety profile of Venclyxto is based on data from 546 patients with CLL treated in clinical trials with venetoclax in combination with rituximab or as monotherapy.
Danish: Venclyxtos overordnede sikkersprofil er baseret på data fra 546 patienter med CLL behandlet i kliniske studier med venetoclax i kombination med rituximab eller som monoterapi.
English: Signs may include fever, chills, feeling weak or confused, cough, pain or burning feeling when passing urine.
Danish: Tegnene kan være feber, kulderystelser, svaghed eller forvirring, hoste, smerter eller en brændende fornemmelse, når du lader vandet.
English: Based on venetoclax large volume of distribution and extensive protein binding, dialysis is unlikely to result in significant removal of venetoclax.
Danish: Ud fra venetoclax' store fordelingsvolumen og udtalte proteinbinding vil dialyse sandsynligvis ikke kunne fjerne venetoclax i nævneværdigt omfang.
English: For patients who have had a dosing interruption lasting more than 1 week during the first 5 weeks of dose titration or more than 2 weeks after completing the dose-titration phase, TLS risk should be reassessed to determine if restarting at a reduced dose is necessary (e.g., all or some levels of the dose titration; see Table
Danish: Hos patienter, hvor doseringen har været afbrudt i mere end 1 uge i løbet af de første 5 uger med dosistitrering eller i mere end 2 uger efter afslutning af dosistitreringsfasen, skal risikoen for tumorlysesyndrom vurderes på ny for at afgøre, om det er nødvendigt at genstarte behandlingen med en nedsat dosis (f.eks. alle eller nogle af titreringsniveauerne, se tabel 2).
English: Initiation and titration phase
Danish: Behandlingsstart og titreringsfasen
English: Treatment with Venclyxto should be withheld for any grade 3 or 4 non-haematological toxicities, grade 3 or 4 neutropenia with infection or fever, or grade 4 haematological toxicities, except lymphopenia.
Danish: Venclyxto-behandlingen skal udsættes ved ikke-hæmatologisk grad 3 og 4 toksicitet, grad 3 og 4 neutropeni med infektion eller feber og grad 4 hæmatologisk toksicitet (bortset fra lymfopeni).
English: Total (N=127)
Danish: I alt (N = 127)
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,
Danish: Effektresultater for den præspecificerede primære analyse (skæringsdato for data 8. maj 2017) blev også vurderet af en uafhængig review-kommité (IRC) og viste en statistisk signifikant reduktion på 81% i risikoen for progression eller død hos patienter behandlet med venetoclax + rituximab (hazard-ratio: 0,19 [95% KI: 0,13; 0,28]; P<0,0001).
English: Intravenous fluids should be administered as indicated based on overall risk of TLS or for those who cannot maintain an adequate level of oral hydration.
Danish: Intravenøs væske skal indgives, som angivet, baseret på den generelle risiko for tumorlysesyndrom, eller hvis patienten ikke kan opretholde tilstrækkelig oral hydrering.
English: Venetoclax is a potent, selective inhibitor of B-cell lymphoma (BCL)-2, an anti-apoptotic protein.
Danish: Venetoclax er en potent, selektiv hæmmer af B-celle-lymfom (BCL)-2, et anti-apoptotisk protein.
English: Venclyxto works by blocking a protein in the body called “BCL-2”.
Danish: Venclyxto virker ved at blokere virkningen af et protein i kroppen, der kaldes "BCL-2".
English: It is very important that you drink plenty of water when taking Venclyxto during the first 5 weeks of treatment.
Danish: Det er meget vigtigt, at du drikker masser af vand i de første 5 uger af Venclyxto-behandlingen.
English: Patients should be adequately hydrated during the dose-titration phase to reduce the risk of TLS.
Danish: Patienterne skal hydreres tilstrækkeligt i dosistitreringsfasen for at reducere risikoen for tumorlysesyndrom.
English: This is to see if you can continue to take this medicine safely.
Danish: På den måde kan det kontrolleres, om det er sikkert for dig at fortsætte behandlingen med dette lægemiddel.
English: With venetoclax + rituximab treatment, febrile neutropenia was reported in 4% of patients, grade ≥3 infections in 18%, and serious infections in 21% of patients.
Danish: Ved venetoclax + rituximab behandling blev febril neutropeni rapporteret hos 4% af patienterne, grad ≥3 infektioner hos 18% og alvorlige infektioner hos 21% af patienterne.
English: In total, 130 patients in the venetoclax + rituximab arm completed 2 years of venetoclax treatment without progression.
Danish: I alt gennemførte 130 patienter i venetoclax + rituximab-armen 2 års venetoclax-behandling uden progression.
English: A randomised (1:1), multicenter, open-label phase 3 study evaluated the efficacy and safety of Venclyxto + rituximab versus BR in patients with previously treated CLL.
Danish: Et randomiseret (1:1), multicenter, åbent fase-3 studie evaluerede virkning og sikkerhed af Venclyxto + rituximab overfor BR hos patienter med tidligere behandlet CLL.
English: Vistor hf. Tel: +354 535 7000
Danish: Vistor hf. Sími: +354 535 7000
English: The rates of grade ≥3 laboratory abnormalities relevant to TLS were hyperkalaemia 1%, hyperphosphataemia 1%, and hyperuricaemia 1%.
Danish: Frekvensen af grad ≥3 unormale laboratorieværdier relevante for TLS var hyperkaliæmi 1%, hyperfosfatæmi 1% og hyperurikæmi
English: For events of clinical TLS or blood chemistry changes requiring more than 48 hours to resolve, treatment should be resumed at a reduced dose (see Table 2).
Danish: Ved klinisk tumorlysesyndrom eller ændringer i blodprøver, der ikke fortager sig i løbet af 48 timer, skal behandlingen genoptages med reduceret dosis (se tabel 2).
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.
Danish: Patienterne i Venclyxto + rituximab-armen gennemførte Venclyxtos 5-ugers dosistitreringsplan og fik så 400 mg én gang dagligt i 24 måneder fra 1. dag i 1. rituximab-cyklus indtil sygdomsprogression eller uacceptabel toksicitet.
English: PFS, % (95% CI) 12-month estimate 24-month estimate
Danish: PFS, % (95 % KI) 12-måneders estimat 24-måneders estimat
English: MRD negativity rate at end of combination treatmentb
Danish: MRD-negativitetsrate ved afslutningen på kombinationsbehandlingenb
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)
Danish: Figur 1: Kaplan-Meier-kurver af investigator vurderet progressionsfri overlevelse (intent-to-treat population) i MURANO (skæringsdato for data 8. maj 2018).