FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: Venetoclax binder direkte til BCL-2-proteinets BH3-bindende sted og fortrænger pro-apoptotiske proteiner, der indeholder en BH3-sekvens, som BIM og initierer dermed permeabilisering af mitokondriets ydre membran (MOMP), caspase-aktivering og programmeret celledød.
English: A 17p deletion was detected in 26.9% of patients, TP53 mutations in 26.3%, 11q deletion in 36.5%, and unmutated IgVH gene in 68.3%.
Danish: Der blev påvist 17p-deletion hos 26,9% af patienterne, TP53-mutation hos 26,3%, 11q-deletion hos 36,5% og umuteret IgVH gen hos 68,3%.
English: There are no adequate and well-controlled data from the use of venetoclax in pregnant women.
Danish: Der foreligger ikke tilstrækkelige kontrollerede data fra anvendelse af venetoclax til gravide kvinder.
English: MURANO was a randomised, controlled trial in which 194 patients with previously treated CLL received venetoclax in combination with rituximab.
Danish: MURANO var et randomiseret, kontrolleret studie, hvor 194 patienter med tidligere behandlet CLL, fik venetoclax i kombination med rituximab.
English: The M27 metabolite was negative for genotoxicity in the bacterial mutagenicity and chromosomal aberration assays.
Danish: M27-metabolitten var negativ for genotoksicitet i den bakterielle mutagenicitetstest og kromosomafvigelsestesten.
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.
Danish: Efter administration af en enkelt oral dosis på 200 mg radioaktivt mærket [14C]-venetoclax til raske forsøgspersoner blev > 99,9 % af dosen udskilt i fæces og < 0,1 % udskilt i urinen i løbet af 9 dage.
English: The recommended dose of venetoclax is 400 mg once daily.
Danish: Den anbefalede venetoclax-dosis er 400 mg en gang dagligt.
English: o When you are receiving Venclyxto therapy alone, you will stay on the 400 mg daily dose, which is the standard dose, for as long as necessary.
Danish: o Når du kun får behandling med Venclyxto, skal du blive på en daglig dosis på 400 mg, standarddosis, så længe, som det er nødvendigt.
English: Some people may develop unusual levels of some body salts (such as potassium and uric acid) in the blood caused by the fast breakdown of cancer cells during treatment.
Danish: Nogle mennesker kan udvikle unormale niveauer af salte (såsom kalium og urinsyre) i blodet.
English: No TLS with clinical consequences such as acute renal failure, cardiac arrhythmias or sudden death and/or seizures was observed in these patients.
Danish: Der sås ingen tilfælde af tumorlysesyndrom med kliniske konsekvenser som f.eks. akut nyresvigt, hjertearytmier eller pludselig død og/eller krampeanfald hos disse patienter.
English: This is called tumour lysis syndrome (TLS).
Danish: Dette kaldes tumorlysesyndrom (TLS).
English: Venclyxto film-coated tablets are supplied in PVC/PE/PCTFE aluminium foil blisters containing either 1, 2 or 4 film-coated tablets.
Danish: Venclyxto filmovertrukne tabletter fås i PVC/PE/PCTFE-aluminiumsfolie-blisterkort med enten 1, 2 eller 4 filmovertrukne tabletter.
English: Blood chemistries should be reassessed prior to each subsequent dose increase during the titration phase.
Danish: Blodanalyser skal udføres på ny forud for hver dosisøgning i titreringsfasen.
English: Blood chemistries should be monitored and abnormalities managed promptly.
Danish: Blodprøveanalyser skal monitoreres og abnormiteter korrigeres øjeblikkeligt.
English: Dose modifications for other toxicities
Danish: Dosisændring ved anden toksicitet
English: Substrates of P-gp, BCRP, and OATP1B1
Danish: Substrater for P-gp, BCRP og OATP1B1
English: Reduced renal function (CrCl <80 ml/min) further increases the risk.
Danish: Nedsat nyrefunktion (CrCl < 80 ml/min) øger risikoen yderligere.
English: Venetoclax should be administered to patients with severe renal impairment only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS (see section 4.4).
Danish: Venetoclax bør kun administreres til patienter med svært nedsat nyrefunktion, hvis fordelene opvejer risiciene, og disse patienter skal monitoreres nøje for tegn på toksicitet på grund af den øgede risiko for tumorlysesyndrom (se pkt.
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).
Danish: I fase 2- og 1-studierne blev 352 patienter med tidligere behandlet CLL, som inkluderede 212 patienter med 17p-deletion og 146 patienter, der havde oplevet behandlingssvigt ved en B-celle-receptor-hæmmer behandlet med venetoclax i monoterapi (se pkt.
English: Drink the same amount of water (at least 1.5 to 2 litres daily) two days before and on the day that your dose is increased.
Danish: Drik den samme mængde væske (mindst 1,5 til 2 liter dagligt) fra to dage før, dosis øges, samt på dagen for dosisøgning.
English: Figure 2: Kaplan-Meier curves of overall survival (intent-to-treat population) in MURANO
Danish: Figur 2: Kaplan-Meier-kurver over overlevelse (intent-to-treat population) i MURANO
English: - you are allergic to the active substance venetoclax or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for det aktive stof venetoclax eller et af de øvrige indholdsstoffer i Venclyxto (angivet i punkt 6)
English: • If it is more than 8 hours since the time you usually take your dose, do not take the dose that day.
Danish: • Hvis der er gået mere end 8 timer, siden du skulle have taget din dosis, skal du lade være med at tage din dosis den dag.
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).
Danish: I dosistitreringsfasen skal behandlingen afbrydes og patienterne monitoreres nøje for tegn og symptomer på tumorlysesyndrom (feber, kulderystelser, kvalme, opkastning, forvirring, åndenød, krampeanfald, uregelmæssig hjertefrekvens, mørk eller grumset urin, usædvanlig træthed, muskel- eller ledsmerter, abdominalsmerter og udspilet abdomen) og anden toksicitet (se pkt.
English: The active substance is venetoclax.
Danish: Aktivt stof: venetoclax.
English: Pre-dose: For all patients, blood chemistries should be assessed prior to the initial dose to evaluate kidney function and correct pre-existing abnormalities.
Danish: Før administration: Inden den første dosis skal der udføres blodanalyser hos alle patienter med henblik på vurdering af nyrefunktionen, og eksisterende abnormiteter skal korrigeres.
English: No effects on fertility were observed in fertility and early embryonic development studies in male and female mice.
Danish: Der sås ingen effekt på fertiliteten i studier af fertilitet og tidlig fosterudvikling hos han- og hunmus.
English: Rituximab was initiated after the 5-week dose-titration schedule at 375 mg/m2 for Cycle 1 and 500 mg/m2 for Cycles 26.
Danish: Rituximab blev initieret efter 5ugers dosistitreringsplanen med 375 mg/m2 i cyklus 1 og 500 mg/m2 i cyklus 2-6.
English: It is not known whether the active substance in Venclyxto passes into breast milk.
Danish: Det er ukendt, om det aktive stof i Venclyxto udskilles i mælken hos mennesker.
English: The observed PFS benefit of venetoclax + rituximab compared with bendamustine + rituximab was consistently observed across all subgroups of patients evaluated, including age (< 65, ≥ 65 years and < 75, ≥ 75 years), prior lines of therapy (1, >1), bulky disease (< 5 cm, ≥ 5 cm), 17p deletion, 11q deletion, TP53 mutation, IgVH mutation, and refractory versus relapse to most recent therapy (Figure 3).
Danish: Den observerede PFS-fordel ved venetoclax + rituximab sammenlignet med bendamustin + rituximab var konsistent observeret på tværs af alle undergrupper af evaluerede patienter, hvilket inkluderede alder (< 65, ≥ 65 år og < 75, ≥ 75 år), tidligere behandlingslinier (1, >1), udbredt sygdom (< 5 cm, ≥ 5 cm), 17p-deletion, 11q-deletion, TP53-mutation, IgVH mutation og refraktær mod relaps ved den seneste behandling (figur 3).
English: Do not breast-feed while you are taking this medicine.
Danish: Du må ikke amme, mens du tager dette lægemiddel.
English: For an orally administered P-gp or BCRP substrate sensitive to inhibition in the gastrointestinal tract (e.g., dabigatran exetilate), its administration should be separated from venetoclax administration as much as possible to minimise a potential interaction.
Danish: Administrationen af et oralt P-gp- eller BCRP-substrat, som kan hæmmes i mave-tarm-kanalen (f.eks. dabigatranexetilat), skal være adskilt så meget som muligt fra administrationen af venetoclax for at minimere en potentiel interaktion.
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.
Danish: Testikulær toksicitet (tab af kimceller) blev observeret i studier af generel toksicitet hos hunde ved eksponeringer på 0,5-18 gange eksponeringen (AUC) hos mennesker ved den anbefalede dosis.
English: Tell your doctor, pharmacist or nurse immediately if you get any of the symptoms of TLS listed in section 4.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet med det samme, hvis du får et eller flere af de symptomer på tumorlysesyndrom, der er anført i punkt 4.
English: You should start drinking at least 1.5 to 2 litres of water daily two days before starting Venclyxto.
Danish: Du skal begynde at drikke mindst 1,5 til 2 liter vand dagligt fra to dage før, du starter behandlingen med Venclyxto.
English: The population estimate for apparent volume of distribution (Vdss/F) of venetoclax ranged from 256-321 L in patients.
Danish: I en farmakokinetisk populationsanalyse blev venetoclax' tilsyneladende fordelingsvolumen (Vdss/F) hos patienter estimeret til 256-321 liter.
English: All six patients completed the dose titration and reached the recommended daily dose of 400 mg of venetoclax.
Danish: Alle seks patienter gennemførte dosistitreringen og opnåede den anbefalede daglige dosis på 400 mg venetoclax.
English: The film-coated tablets are supplied in cartons containing either 7 (in blisters of 1 tablet) or 14 tablets (in blisters of 2 tablets); or a multipack containing 112 tablets (4 x 28 tablets (in blisters of 4 tablets)).
Danish: De filmovertrukne tabletter leveres i æsker med 7 (i blistre med 1 tablet) eller 14 tabletter (i blistre med 2 tabletter) eller en multipakning med 112 tabletter (4x28 i blistre med 4 tabletter)
English: This includes medicines obtained without a prescription, herbal medicines and supplements.
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og kosttilskud.
English: Venetoclax is predominantly metabolised by CYP3A.
Danish: Venetoclax metaboliseres hovedsagelig via CYP3A.
English: Rituximab should be administered after the patient has completed the dose-titration schedule and has received the recommended daily dose of 400 mg venetoclax for 7 days.
Danish: Rituximab bør adminstreres efter patienten har afsluttet dosistitreringsplanen og har fået den anbefalede daglige dosis på 400 mg venetoclax i 7 dage.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Venclyxto in all subsets of the paediatric population in CLL (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier af Venclyxto i alle undergrupper af den pædiatriske population med CLL (se pkt.
English: At the time of evaluation, median duration of treatment with venetoclax was 14.3 months (range: 0.1 to 31.4 months).
Danish: På vurderingstidspunktet var den mediane behandlingsvarighed af venetoclax 14,3 måneder (interval: 0,1-31,4 måneder).
English: Venetoclax is not expected to inhibit OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1 or MATE2K at clinically relevant concentrations.
Danish: Venetoclax forventes ikke at hæmme OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1 eller MATE2K ved klinisk relevante koncentrationer.
English: Post-dose: For patients at risk of TLS, blood chemistries should be monitored at 6 to 8 hours and at 24 hours after the first dose of venetoclax.
Danish: Efter administration: Hos patienter med risiko for tumorlysesyndrom skal blodanalyser monitoreres 6-8 timer samt 24 timer efter den første dosis venetoclax.
English: Tell your doctor if you take any of the following medicines as Venclyxto may affect how they work:
Danish: Fortæl det altid til lægen, hvis du tager et eller flere af følgende lægemidler, da Venclyxto kan påvirke deres virkning:
English: • upper respiratory tract infection - signs include runny nose, sore throat or cough
Danish: • infektion i de øvre luftveje - tegnene kan f.eks. være løbende næse, ondt i halsen eller hoste
English: If your doctor thinks that you are at risk of TLS, you may be treated in the hospital so that you can be given extra fluids into the vein if needed, have your blood tests more often and be checked for side effects.
Danish: Hvis din læge vurderer, at du er i risiko for at få tumorlysesyndrom, kan du blive behandlet på hospitalet, så du om nødvendigt kan få ekstra væske i en blodåre (væskedrop), få taget blodprøver oftere og blive overvåget for bivirkninger.
English: If a bile acid sequestrant is to be co-administered with venetoclax, the SmPC for the bile acid sequestrant should be followed to reduce the risk for an interaction, and venetoclax should be administered at least 4-6 hours after the sequestrant.
Danish: Hvis en galdesyre-kompleksdanner skal administreres sammen med venetoclax, skal produktresuméet for galdesyre-kompleksdanneren følges for at mindske risikoen for interaktion, og venetoclax skal administreres mindst 4-6 timer efter kompleksdanneren.
English: In the film-coating:
Danish: Filmovertræk:
English: No dose adjustment is recommended in patients with mild or moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendigt hos patienter med let eller moderat nedsat leverfunktion.
English: Venclyxto in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.
Danish: Venclyxto i kombination med rituximab er indiceret til behandling af kronisk lymfatisk leukæmi (CLL) hos voksne patienter, der har fået mindst en tidligere behandling.
English: Table 2: Dose modification for TLS and other toxicities
Danish: Tabel 2: Dosisændring ved tumorlysesyndrom og anden toksicitet
English: Co administration with CYP and UGT substrates
Danish: Samtidig administration af CYP- og UGT-substrater
English: Venclyxto tablets are provided in blisters which are packed in cartons as follows:
Danish: Venclyxto-tabletter er tilgængelige i blisterkort, der er pakket i æsker:
English: A risk to the breast-feeding child cannot be excluded.
Danish: En risiko for børn, som ammes, kan ikke udelukkes.
English: The median number of prior oncology treatments was 4 (range: 1 to 15) in ibrutinib-treated patients and 3 (range: 1 to 11) in idelalisib-treated patients.
Danish: Det mediane antal tidligere cancerbehandlinger var 4 (interval: 1-15) for patienter i ibrutinib-gruppen og 3 (interval: 1-11) for patienter i idelalisib-gruppen.
English: Venetoclax in combination with rituximab for the treatment of patients with CLL who have received at least one prior therapy - study GO28667 (MURANO)
Danish: Venetoclax i kombination med rituximab til behandling af patienter med CLL, der har fået mindst en tidligere behandling - studie GO28667 (MURANO)
English: o When you are receiving Venclyxto therapy in combination with rituximab, you will receive the 400 mg daily dose for 24 months.
Danish: o Når du får behandling med Venclyxto i kombination med rituximab, vil du få en dosis på 400 mg dagligt i 24 måneder.
English: You will begin treatment with Venclyxto at a low dose for 1 week.
Danish: Du skal starte behandlingen med at tage en lav dosis Venclyxto i 1 uge.
English: Administration with a low-fat meal increased venetoclax exposure by approximately 3.4-fold and administration with a high-fat meal increased venetoclax exposure by 5.1- to 5.3-fold compared to fasting conditions.
Danish: Administration sammen med et fedtfattigt måltid øgede venetoclax-eksponeringen med ca. 3,4 gange, og administration sammen med et fedtrigt måltid øgede venetoclax-eksponeringen med 5,1-5,3 gange i forhold til administration under faste.
English: In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.
Danish: I monoterapi-studierne, var de mest almindelige bivirkninger neutropeni/nedsat neutrofiltal, diarré, kvalme, anæmi, træthed og infektion i de øvre luftveje.
English: In non-clinical studies, venetoclax has demonstrated cytotoxic activity in tumour cells that overexpress BCL-2.
Danish: I prækliniske studier har venetoclax vist cytotoksisk aktivitet i tumorceller, der har overekspression af BCL-2.
English: Reduced renal function (creatinine clearance [CrCl] <80 ml/min) further increases the risk.
Danish: Nedsat nyrefunktion (kreatininclearance [CrCl] < 80 ml/min) øger risikoen yderligere.
English: Co-administration of venetoclax with other strong CYP3A4 inhibitors is predicted to increase venetoclax AUC by on average 5.8- to 7.8-fold.
Danish: Samtidig administration af venetoclax og andre potente CYP3A4-hæmmere formodes at kunne øge venetoclax-AUC gennemsnitlig 5,8-7,8 gange.
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).
Danish: Det primære effektmål var den samlede responsrate (ORR) vurderet af en uafhængig review-komité på baggrund af 2008-retningslinjerne fra IWCLL opdateret af NCI-WG.
English: If a patient experiences blood chemistry changes suggestive of TLS, the following day's venetoclax dose should be withheld.
Danish: Hvis der hos en patient ses ændringer i blodprøver, der kan være tegn på tumorlysesyndrom, skal venetoclaxdosering undlades den efterfølgende dag.
English: • lower number of white blood cells called lymphocytes
Danish: • nedsat antal hvide blodlegemer, de såkaldte lymfocytter
English: No dose adjustment is needed for patients with mild or moderate renal impairment (CrCl ≥30 ml/min and <90 ml/min) (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion (CrCl ≥ 30 ml/min og < 90 ml/min) (se pkt.
English: The starting dose is 20 mg of venetoclax once daily for 7 days.
Danish: Startdosis er 20 mg venetoclax én gang dagligt i 7 dage.
English: Also some other medicines can affect the way Venclyxto works.
Danish: Nogle lægemidler kan også påvirke den måde, Venclyxto virker på.
English: The risk may decrease as tumour burden decreases with venetoclax treatment (see section 4.4).
Danish: Risikoen mindskes, efterhånden som tumorbyrden falder i løbet af venetoclax-behandlingen (se pkt.
English: Anti-hyperuricaemic agents should be administered 2 to 3 days prior to starting treatment with venetoclax in patients with high uric acid levels or at risk of TLS and may be continued through the titration phase.
Danish: Midler mod hyperurikæmi skal administreres 2-3 dage inden påbegyndelse af venetoclax-behandling hos patienter med højt urinsyreniveau eller med risiko for tumorlysesyndrom; disse midler kan administreres i hele titreringsfasen.
English: In rabbits, venetoclax produced maternal toxicity, but no foetal toxicity at exposures of 0.1 times the human AUC exposure at the recommended dose.
Danish: Hos kaniner medførte venetoclax maternel toksicitet, men ingen føtal toksicitet, ved eksponeringer svarende til 0,1 gange eksponeringen (AUC) hos mennesker ved den anbefalede dosis.
English: Blocking this protein helps to kill and lower the number of cancer cells.
Danish: Ved at blokere virkningen af dette protein hjælper Venclyxto med at dræbe kræftcellerne og reducere antallet af dem.
English: The median time on treatment for 158 patients was 17 months (range: 0 to 34 months).
Danish: Den mediane behandlingstid for de 158 patienter var 17 måneder (interval: 0 til 34 måneder).
English: In the open-label, randomised phase 3 study (MURANO), the incidence of TLS was 3% (6/194) in patients treated with venetoclax + rituximab.
Danish: I det åbne, randomiserede fase 3-studie (MURANO), var incidensen af TLS 3% (6/194) hos patienter behandlet med venetoclax + rituximab.
English: If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist, or nurse before taking this medicine.
Danish: Hvis noget af ovenstående gælder for dig, eller hvis du er i tvivl, skal du tale med lægen, apotekspersonalet eller sundhedspersonalet, før du tager dette lægemiddel.
English: In vitro studies indicated that venetoclax is not an inhibitor or inducer of CYP1A2, CYP2B6, CYP2C19, CYP2D6 or CYP3A4 at clinically relevant concentrations.
Danish: In vitro-studier tyder på, at venetoclax ikke hæmmer eller inducerer CYP1A2, CYP2B6, CYP2C19, CYP2D6 eller CYP3A4 ved klinisk relevante koncentrationer.
English: The instructions for “Prevention of tumour lysis syndrome” should be followed (see section 4.2).
Danish: Anvisningerne for "Forebyggelse af tumorlysesyndrom" skal følges (se pkt.
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.
Danish: En farmakokinetisk populationsanalyse, der omfattede 219 personer med let nedsat nyrefunktion (CrCl ≥ 60 og < 90 ml/min), 86 personer med moderat nedsat nyrefunktion (CrCl ≥ 30 og < 60 ml/min) og 217 personer med normal nyrefunktion (CrCl ≥ 90 ml/min), viste, at venetoclax-eksponeringen hos personer med let til moderat nedsat nyrefunktion svarer til eksponeringen hos personer med normal nyrefunktion.
English: Venetoclax is not an inhibitor of UGT1A4, UGT1A6, UGT1A9 and UGT2B7.
Danish: Venetoclax hæmmer ikke UGT1A4, UGT1A6, UGT1A9 og UGT2B7.
English: • 112 (4 x 28) tablets (4 cartons of 7 blisters each with 4 tablets).
Danish: • 112 (4 x 28) tabletter (4 æsker med 7 blisterkort hver med 4 tabletter).
English: The frequencies of adverse reactions reported with Venclyxto are summarised in Table 3.
Danish: Hyppigheden af bivirkninger ved Venclyxto er vist i tabel 3.
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.
Danish: • uden tilstedeværelse af 17p-deletion eller TP53-mutation hos voksne patienter, hvor både kemoimmunbehandling og en B-celle-receptor-hæmmer har fejlet.
English: Venetoclax is a weak inhibitor of CYP2C8, CYP2C9 and UGT1A1 in vitro, but it is not predicted to cause clinically relevant inhibition.
Danish: Venetoclax er en svag hæmmer af CYP2C8, CYP2C9 og UGT1A1 in vitro, men forventes ikke at forårsage klinisk relevant hæmning.
English: The 5-week dose-titration schedule is designed to gradually reduce tumour burden (debulk) and decrease the risk of tumour lysis syndrome.
Danish: Doseringsplanen med dosistitrering over 5 uger er udformet for at reducere tumorbyrden gradvist og mindske risikoen for tumorlysesyndrom.