FrancophonIA/ELRC3.0 huggingface dataset:
English: Some infections can be serious and may lead to death.
Danish: Nogle infektioner kan være alvorlige og kan medføre døden.
English: Ελλάδα AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
Danish: AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
English: Reversibility of this finding has not been demonstrated.
Danish: Der er ikke blevet påvist reversibilitet af dette fund.
English: Frequency (all grades)a
Danish: Hyppighed (alle grader)a
English: It also slows down the worsening of the disease.
Danish: Det hæmmer også udviklingen af sygdommen.
English: • you are due to have a vaccine.
Danish: • hvis du skal vaccineres.
English: Copovidone (K 28)
Danish: Copovidon (K 28)
English: Your doctor will advise what your dose should be.
Danish: Din læge vil fortælle dig, hvad din dosis skal være.
English: • Swallow the tablets whole with a glass of water
Danish: • Synk tabletterne hele med et glas vand
English: Effect of food
Danish: Virkningen af mad
English: • you think you may have an infection or have had a long-lasting or repeated infection
Danish: • hvis du tror, at du har en infektion, eller hvis du har en længerevarende eller tilbagevendende infektion
English: Effects of age, sex, and weight
Danish: Betydningen af alder, køn og vægt
English: 12-month estimate
Danish: 12-måneders estimat
English: 17p deletion status was determined based on central laboratory test results.
Danish: 17p-deletion status blev bestemt på baggrund af centrale laboratorietestresultater.
English: Supportive measures including antimicrobials for any signs of infection should be considered.
Danish: Understøttende foranstaltninger, herunder antimikrobielle lægemidler, bør overvejes ved ethvert tegn på infektion.
English: Number of events (%) Disease progression Death events
Danish: Antal hændelser (%) Sygdomsprogression Dødsfald
English: Response assessments were performed at 8 weeks, 24 weeks, and every 12 weeks thereafter.
Danish: Der blev foretaget responsvurderinger efter 8 uger og efter 24 uger og derefter hver 12. uge.
English: Date of first authorisation: 5 December 2016 Date of latest renewal: 6 September 2018
Danish: Dato for første markedsføringstilladelse: 5. december 2016 Dato for seneste fornyelse: 6 September 2018.
English: Take your dose in the morning with a meal and water.
Danish: Tag din dosis om morgenen sammen med et måltid og vand.
English: IRC assessed
Danish: IRC vurderet
English: Complete blood counts should be monitored throughout the treatment period.
Danish: Alle blodtal skal monitoreres i hele behandlingsperioden.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterkortet efter EXP.
English: Additional efficacy results for the pre-specified primary analysis are shown in Table 5 and Figure 2 and Figure 3.
Danish: Yderligere effektresultater for den præspecificerede primære analyse er vist i tabel 5 og figur 2 og figur 3.
English: In CLL, the lymphocytes multiply too quickly and live for too long, so that there are too many of them in the blood.
Danish: Ved CLL formerer lymfocytterne sig for hurtigt og lever for længe, så der er for mange af dem i blodet.
English: All patients had CrCl ≥50 ml/min.
Danish: Alle patienterne havde CrCl ≥ 50 ml/min.
English: This protein helps cancer cells survive.
Danish: Dette protein hjælper kræftcellerne med at overleve.
English: In vitro interaction studies
Danish: Interaktionsstudier in vitro
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl
English: Grade ≥3a
Danish: Grad ≥3a
English: The mean blood-to-plasma ratio was 0.57.
Danish: Den gennemsnitlige blod/plasma-ratio var 0,57.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer)
English: Treatment with venetoclax should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Danish: Behandling med venetoclax skal indledes og superviseres af en læge med erfaring i lægemidler mod cancer.
English: Time to next anti-leukaemic therapy Number of events (%)
Danish: Tid til næste anti-leukæmi behandling Antal hændelser (%)
English: Results of subgroup analyses
Danish: Resultater af undergruppe analyser
English: More intensive measures should be employed as overall risk increases.
Danish: Der skal træffes skærpede foranstaltninger, når den generelle risiko øges.
English: • During the first 5 weeks of treatment, you should take the tablets in the morning to help you follow-up with blood tests, if needed.
Danish: • I de første 5 uger af behandlingen skal du tage tabletterne om morgenen, så der om nødvendigt kan følges op med blodprøver.
English: Additional efficacy results in MURANO Investigator assessed
Danish: Yderligere effektresultater i MURANO Investigator vurderet
English: Treatment should be continued until disease progression or no longer tolerated by the patient.
Danish: Behandlingen bør fortsætte indtil sygdomsprogression eller så længe, den tåles af patienten.
English: This will help to remove cancer cell breakdown products from your blood through your urine.
Danish: På den måde kan du bidrage til at få fjernet kræftcellernes nedbrydningsprodukter fra dit blod via urinen.
English: Investigator assessment (N=158)b
Danish: Investigators vurdering (N = 158)b
English: Median DOR was not reached with median follow up of approximately 23.8 months.
Danish: Median DOR blev ikke opnået ved median opfølgning i op til omkring 23,8 måneder.
English: Drink 1.5-2 litres of water a day.
Danish: Drik 1,5 til 2 liter vand hver dag.
English: eOverall survival data are not yet mature.
Danish: eSamlede overlevelsesdata er endnu ikke tilstrækkelige.
English: 28 film-coated tablets Component of a multipack, can't be sold separately.
Danish: 28 filmovertrukne tabletter Delpakning af multipakning - må ikke sælges separat.
English: More intensive measures (intravenous hydration, frequent monitoring, hospitalisation) should be employed as overall risk increases.
Danish: Mere intensive foranstaltninger (intravenøs hydrering, hyppig monitorering, indlæggelse) skal anvendes, når den generelle risiko øges.
English: At the time of data cut-off (26 July 2017), 127 patients were enrolled and treated with venetoclax.
Danish: På skæringsdatoen for data (26. juli 2017) var 127 patienter inkluderet og behandlet med venetoclax.
English: The prophylaxis measures listed below should be followed.
Danish: Nedenstående profylaktiske foranstaltninger skal iværksættes.
English: An additional 51 patients were enrolled in a safety expansion cohort.
Danish: Yderligere 51 patienter indgik i en udvidet kohorte til vurdering af sikkerheden.
English: The estimated PFS rate at 6 months post treatment was 92%.
Danish: Den estimerede PFS-rate ved 6 månder efter behandling var 92%.
English: The risk of TLS is a continuum based on multiple factors, including comorbidities.
Danish: Risikoen for tumorlysesyndrom er et kontinuum af mange faktorer, herunder komorbiditeter.
English: The safety and efficacy of immunisation with live attenuated vaccines during or following venetoclax therapy have not been studied.
Danish: Sikkerheden ved og virkningen af immunisering med levende svækkede vacciner under eller efter venetoclax-behandling er ikke undersøgt.
English: • low number of white blood cells with fever (febrile neutropenia)
Danish: • lavt antal hvide blodlegemer og feber (febril neutropeni)
English: Both B- and T-cells were affected, but the most significant decreases occurred with B-cells.
Danish: Både B- og T-celler blev påvirket, men faldet i B-celler var mest signifikant.
English: Patients who experience overdose should be closely monitored and appropriate supportive treatment provided.
Danish: Patienter, der har fået en overdosis, skal monitoreres nøje og have passende understøttende behandling.
English: Tell your doctor if you notice any of the following side effects: Very common
Danish: Fortæl det til lægen, hvis du oplever en eller flere af følgende bivirkninger: Meget almindelige bivirkninger
English: The tablets should not be chewed, crushed, or broken before swallowing.
Danish: Tabletterne må ikke tygges, knuses eller deles, inden de sluges.
English: Alternative treatments should be considered.
Danish: Andre behandlinger bør overvejes.
English: Unstratified hazard ratio is displayed on the X-axis with logarithmic scale.
Danish: Ustratificeret hazard-ratio vises på X-aksen med en logoritmisk skala.
English: • Take the tablets with a meal at around the same time each day
Danish: • Tag tabletterne i forbindelse med et måltid på nogenlunde samme tidspunkt hver dag
English: Investigator-assessed efficacy results are presented for 158 patients with a later data cutoff date 10 June 2016.
Danish: Investigator-evaluerede effekt resultater er vist for 158 patienter med en senere skæringsdato for data 10. juni 2016.
English: The following serious side effects may happen with this medicine:
Danish: Dette lægemiddel kan give følgende alvorlige bivirkninger:
English: For patients who require dose reductions to less than 100 mg for more than 2 weeks, discontinuation of venetoclax should be considered.
Danish: Hos patienter, hvor dosisreduktion til mindre end 100 mg i mere end 2 uger er nødvendig, skal seponering af venetoclax overvejes.
English: Efficacy results are shown in Table 6.
Danish: Effektresultaterne er vist i tabel 6.
English: Venclyxto with food and drink
Danish: Brug af Venclyxto sammen med mad og drikke
English: It is currently unknown whether venetoclax may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method.
Danish: Det vides ikke på nuværende tidspunkt, om venetoclax kan mindske virkningen af hormonelle præventionsmidler, og derfor skal kvinder, der benytter hormonel prævention, også bruge en barrieremetode.
English: aOne patient did not harbour the 17p deletion.
Danish: (interval) aEn patient havde ikke 17p-deletion.
English: Venetoclax had no effect on QTc interval and there was no relationship between venetoclax exposure and change in QTc interval.
Danish: Venetoclax havde ingen indvirkning på QTc-intervallet, og der var ingen relation mellem venetoclax-eksponering og ændring i QTc-intervallet.
English: Low white blood cell count can increase your risk for infection.
Danish: Et lavt antal hvide blodlegemer kan medføre øget risiko for infektioner.
English: Hospitalisation should be considered for subsequent dose increases based on reassessment of risk.
Danish: Indlæggelse bør overvejes ved efterfølgende dosisstigninger baseret på fornyet risikovurdering.
English: Forest plot of Investigator-Assessed PFS in Subgroups from MURANO
Danish: Forest plot af investigator-vurderet PFS i undergrupper fra MURANO
English: • a medicine for cancer known as everolimus
Danish: • et lægemiddel mod kræft - everolimus
English: aThe modified dose should be continued for 1 week before increasing the dose.
Danish: aDen ændrede dosis bør fastholdes i 1 uge, før dosis øges igen.
English: After completion of titration phase
Danish: Efter afslutning af titreringsfasen
English: • ritonavir for HIV infection.
Danish: • ritonavir mod hiv-infektion.
English: Serious infections including events of sepsis with fatal outcome have been reported.
Danish: Der er rapporteret om alvorlige infektioner inklusive tilfælde af sepsis med letal udgang.
English: Take your dose at the same time each day with a meal and water.
Danish: Tag din dosis på samme tidspunkt hver dag sammen med et måltid og vand.
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).
Danish: Progressionsfri overlevelse (PFS) blev vurderet af investigator ved brug af International Workshop for Chronic Lymphocytic Leukemia (IWCLL) opdateret af National Cancer Institute-sponsorerede arbejdsgruppe (NCI-WG) retningslinier (2008).
English: • lower number of red blood cells
Danish: • nedsat antal røde blodlegemer
English: - Venclyxto should not be used during pregnancy.
Danish: - Venclyxto må ikke anvendes under graviditet.
English: Efficacy results for PFS at the time of pre-specified primary analysis (data cut-off date 8 May 2017) are shown in Table 4.
Danish: Effektresultater for PFS ved tiden for den præspecificerede primære analyse (skæringsdato for data 8. maj 2017) ses i tabel 4.
English: It is unknown whether venetoclax or its metabolites are excreted in human milk.
Danish: Det er ukendt, om venetoclax eller dets metabolitter udskilles i human mælk.
English: • you have liver problems as this may increase your risk for side effects.
Danish: • hvis du har leverproblemer, da det kan øge din risiko for at få bivirkninger.
English: - Do not get pregnant while you are taking this medicine.
Danish: - Du må ikke blive gravid, mens du tager dette lægemiddel.
English: • clarithromycin for bacterial infections
Danish: • clarithromycin mod bakterieinfektioner
English: Venetoclax shows minimal accumulation with accumulation ratio of 1.30-1.44.
Danish: Venetoclax udviser minimal akkumulation med en akkumulations-ratio på 1,301,44.
English: Unchanged venetoclax accounted for 20.8% of the administered radioactive dose excreted in faeces.
Danish: Uomdannet venetoclax udgjorde 20,8 % af den administrerede radioaktive dosis, der blev udskilt i fæces.
English: Dosing should be interrupted if needed (see section 4.2).
Danish: Behandlingen skal om nødvendigt afbrydes (se pkt.
English: Tell your doctor immediately if you have signs of an infection while taking this medicine.
Danish: Kontakt lægen med det samme, hvis du oplever tegn på infektion, mens du tager dette lægemiddel.
English: aThe discrepancy between IRC- and investigator-assessed CR rate was due to interpretation of residual adenopathy on CT scans.
Danish: aForskellen mellem IRC- og investigator-vurderet CR rate skyldtes fortolkningen af resterende adenopati på CT-skanninger.
English: Of the 130 patients, 92 patients completed the 6-month post treatment follow-up visit.
Danish: 92 patienter ud af de 130 patienter gennemførte 6-måneders opfølgningsbesøget.
English: Tell your doctor or pharmacist if you take any of the following medicines as they can increase or decrease the amount of venetoclax in your blood:
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager et eller flere af følgende lægemidler, da de kan mindske eller øge mængden af venetoclax i dit blod:
English: Live vaccines should not be administered during treatment and thereafter until B-cell recovery.
Danish: Levende vacciner bør ikke administreres under behandlingen, og først når B-cellerne er normaliserede efter behandlingen.
English: Median OS and DOR were not reached with median follow-up of approximately 14.3 months for Arm A and 14.7 months for Arm B.
Danish: Median OS og DOR var ikke nået efter en median opfølgning på omkring 14,3 måneder i gruppe A og 14,7 måneder i gruppe B.
English: During the dose-titration phase, venetoclax should be taken in the morning to facilitate laboratory monitoring.
Danish: I dosistitreringsfasen skal venetoclax tages om morgenen for at lette monitorering af laboratorieværdierne.
English: The tablets should be taken with a meal in order to avoid a risk for lack of efficacy (see section 5.2).
Danish: Tabletterne skal tages sammen med et måltid for at undgå risiko for manglende virkning (se pkt.
English: MRD negativity was defined as a result below 0.0001 (<1 CLL cell per 104 leukocytes in the sample).
Danish: MRD-negativitet blev defineret som et resultat under 0,0001 (< 1 CLL-celle pr. 104 leukocytter i prøven).
English: Patients continued to receive venetoclax 400 mg once daily until disease progression or unacceptable toxicity was observed.
Danish: Patienterne fortsatte med at få venetoclax 400 mg én gang dagligt indtil sygdomsprogression eller uacceptabel toksicitet.
English: Patients should be instructed to swallow the tablets whole with water at approximately the same time each day.
Danish: Patienterne skal sluge tabletterne hele sammen med vand på nogenlunde samme tidspunkt hver dag.
English: Electrolyte abnormalities should be corrected promptly.
Danish: Elektrolytændringer skal korrigeres øjeblikkeligt.
English: Following multiple oral administrations, maximum plasma concentration of venetoclax was reached 5-8 hours after dose.
Danish: Efter multiple orale doser blev den maksimale plasmakoncentration af venetoclax nået 5-8 timer efter indgift.
English: Venclyxto may be given to you in combination with rituximab or alone.
Danish: Du kan få Venclyxto i kombination med rituximab eller alene.
English: EU/1/16/1138/001 (10 mg, 10 tablets) EU/1/16/1138/002 (10 mg, 14 tablets) EU/1/16/1138/003 (50 mg, 5 tablets) EU/1/16/1138/004 (50 mg, 7 tablets) EU/1/16/1138/005 (100 mg 7 tablets) EU/1/16/1138/006 (100 mg, 14 tablets) EU/1/16/1138/007 (100 mg, 112 (4 x 28) tablets)
Danish: EU/1/16/1138/001 (10 mg, 10 tabletter) EU/1/16/1138/002 (10 mg, 14 tabletter) EU/1/16/1138/003 (50 mg, 5 tabletter) EU/1/16/1138/004 (50 mg, 7 tabletter) EU/1/16/1138/005 (100 mg 7 tabletter) EU/1/16/1138/006 (100 mg, 14 tabletter) EU/1/16/1138/007 (100 mg, 112 (4 x 28) tabletter)
English: Kaplan-Meier curves of investigator-assessed PFS from the updated efficacy analysis are shown in Figure 1.
Danish: Kaplan-Meier-kurver af investigator vurderet PFS fra den opdaterede effektanalyse er vist i figur 1.
English: • a medicine used to treat heart problems known as digoxin
Danish: • et lægemiddel, der anvendes til at behandle hjerteproblemer - digoxin
English: Take the tablets and this leaflet with you.
Danish: Medbring tabletterne og denne indlægsseddel.
English: Your doctor may also give you medicines to help prevent the build up of uric acid in your body before you start treatment with Venclyxto.
Danish: Lægen kan også give dig medicin for at forebygge ophobning urinsyre i kroppen, før du begynder at tage Venclyxto.
English: Bendamustine + rituximab N = 195
Danish: Bendamustin + rituximab N = 195
English: • itraconazole ketoconazole, posaconazole, or voriconazole for fungal infections
Danish: • itraconazol, ketoconazol, posaconazol eller voriconazol mod svampeinfektioner
English: This is because Venclyxto may affect the way some other medicines work.
Danish: Det skyldes, at Venclyxto kan påvirke den måde, andre lægemidler virker på.
English: The same monitoring schedule should be followed at the start of the 50 mg dose and then for patients who continue to be at risk, at subsequent dose increases.
Danish: Det samme monitoreringsmønster skal følges ved stigning til 50 mg-dosen og derefter ved efterfølgende dosisstigninger hos patienter, som fortsat er i risiko.
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.
Danish: Da venetoclax ikke blev doseret til steady state, anbefales det, at INR (international normaliseret ratio) monitoreres nøje hos patienter, der får warfarin.
English: The cut-off for a negative status was one CLL cell per 104 leukocytes.
Danish: Skæringpunktet for negativ status var én CLL celle pr 104 leukocytter.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX52
Danish: Farmakoterapeutisk klassifikation: andre antineoplastiske stoffer, ATC-kode: L01XX52
English: All events of TLS occurred during the venetoclax dose-titration phase and resolved within two days.
Danish: Alle tilfælde af TLS forekom i venetoclax-dosistitreringsfasen og aftog inden for 2 dage.
English: The safety analysis included patients from one phase 3 study (MURANO), two phase 2 studies (M13-982 and M14-032), and one phase 1 study (M12-175).
Danish: Sikkerhedsanalysen inkluderede patienter fra et fase 3-studie (MURANO), to fase 2-studier (M13-982 og M14-032) og et fase 1-studie (M12175).
English: CLL is a type of cancer affecting white blood cells called lymphocytes and the lymph nodes.
Danish: CLL er en type kræft, der påvirker de hvide blodlegemer, der kaldes lymfocytter, og lymfeknuderne.
English: You may feel tired after taking Venclyxto, which may affect your ability to drive or use tools or machines.
Danish: Du kan føle dig træt, når du har taget Venclyxto, og det kan påvirke din evne til at køre motorkøretøjer og betjene værktøjer og maskiner.
English: Fatigue has been reported in some patients taking venetoclax and should be considered when assessing a patient's ability to drive or operate machines.
Danish: Der er rapporteret om træthed hos nogle patienter, der tager venetoclax, og der skal tages højde herfor, når en patients evne til at føre motorkøretøj eller betjene maskiner vurderes.
English: • Do not chew, crush, or break the tablets
Danish: • Du må ikke tygge, knuse eller dele tabletterne
English: Co-administration of CYP3A4 inducers may lead to decreased venetoclax exposure and consequently a risk for lack of efficacy.
Danish: Samtidig administration af CYP3A4-induktorer kan medføre nedsat venetoclax-eksponering og dermed risiko for manglende effekt.
English: • medicines to lower cholesterol levels in the blood known as statins
Danish: • lægemidler, der anvendes til at sænke indholdet af kolesterol i blodet - kaldet statiner
English: The pharmacokinetics of venetoclax do not change over time.
Danish: Farmakokinetikken for venetoclax ændres ikke over tid.
English: Efficacy data are presented for 107 patients with data cutoff date 30 April 2015.
Danish: Effektdata er vist for 107 patienter med skæringsdato for data 30. april 2015.
English: Based on population pharmacokinetic analyses, age, sex, and weight do not have an effect on venetoclax clearance.
Danish: Farmakokinetiske populationsanalyser har vist, at alder, køn og vægt ikke har nogen indvirkning på clearance af venetoclax.
English: Of these, 91 patients had received prior ibrutinib therapy (Arm A) and 36 had received prior idelalisib therapy (Arm B).
Danish: Heraf havde 91 patienter tidligere fået ibrutinib (gruppe A), og 36 havde tidligere fået idelalisib (gruppe B).
English: Arm B (idelalisib failures) (N=36)
Danish: Gruppe B (behandlingssvigt ved idelalisib) (N = 36)
English: The next venetoclax dose should not be administered until the 24-hour blood chemistry results have been evaluated.
Danish: Den næste venetoclax-dosis må ikke administreres, før resultaterne af den blodprøveanalyse 24 timer efter den første dosis er blevet vurderet.
English: It is important that you tell your doctor, pharmacist, or nurse about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Danish: Det er vigtigt, at du fortæller lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin, herunder receptpligtige lægemidler og håndkøbsmedicin, vitaminer og kosttilskud.
English: Minimal residual disease (MRD) was evaluated using flow cytometry in 93 of 158 patients who achieved complete remission (CR), complete remission with incomplete marrow recovery (CRi), or partial remission (PR) with limited remaining disease with venetoclax treatment.
Danish: Minimal residual sygdom (MRD) blev vurderet ved hjælp af flowcytometri hos 93 ud af 158 patienter, der opnåede komplet remission (CR), komplet remission med ufuldstændig knoglemarvsregeneration (CRi) eller partiel remission (PR) med begrænset restsygdom efter behandling med venetoclax.
English: The risk of TLS was reduced after revision of the dosing regimen and modification to prophylaxis and monitoring measures.
Danish: Risikoen for tumorlysesyndrom blev mindsket efter ændring af doseringsregimet og af de profylaktiske og monitoreringsmæssige foranstaltninger.