FrancophonIA/ELRC3.0 huggingface dataset:
English: The Cmax of ADC was typically observed at the end of infusion or the sampling closest to the end of infusion.
Danish: Cmax for ADC blev typisk observeret i slutningen af infusionen eller i den prøve, der blev taget tættest på slutningen af infusionen.
English: In clinical trials, the majority of patients had resolution or improvement of their symptoms (see section 4.8).
Danish: I kliniske forsøg opnåede størstedelen af patienterne ophør eller bedring af deres symptomer (se pkt.
English: For intravenous use after reconstitution and dilution
Danish: Til intravenøs brug efter rekonstitution og fortynding.
English: Cough, dyspnoea
Danish: Hoste, dyspnø
English: Of the study's 60 patients, 49 patients (82%) received > 1 prior cancer-related treatment and 11 patients (18%) received 1 prior cancer-related treatment.
Danish: Af studiets 60 patienter havde 49 patienter (82 %) tidligere modtaget > 1 cancerrelateret behandling, og 11 patienter (18 %) havde tidligere fået 1 cancerrelateret behandling.
English: The population pharmacokinetics of brentuximab vedotin were examined from several studies, including data from 380 patients up to 87 years old (34 patients ≥65-< 75 and 17 patients ≥75 years of age).
Danish: Populationsfarmakokinetikken for brentuximab vedotin fra flere studier blev undersøgt, herunder data fra 380 patienter i alderen op til 87 år (34 patienter ≥ 65-< 75 og 17 patienter ≥ 75 år).
English: Adverse events that led to treatment discontinuation in ≥ 2% of patients included peripheral sensory neuropathy, peripheral neuropathy, and peripheral motor neuropathy.
Danish: Bivirkninger, der førte til seponering af behandlingen hos ≥ 2 % af patienterne, omfattede perifer sensorisk neuropati, perifer neuropati og perifer motorisk neuropati.
English: What Adcetris contains
Danish: Adcetris indeholder
English: In the event of new or worsening GI symptoms, perform a prompt diagnostic evaluation and treat appropriately.
Danish: I tilfælde af nye eller forværrede GI-symptomer skal der udføres en omgående diagnostisk vurdering og gennemføres relevant behandling.
English: 31 years (15-77)
Danish: 31 år (15-77)
English: The estimated overall survival at 5 years was 60% (95% CI [47%,73%]).
Danish: Den estimerede samlede overlevelse på 5 år var 60 % (95 KI [47 %, 73 %]).
English: Median number of skin-directed therapies (range) Median number of systemic therapies (range) MF, n (%)
Danish: Mediant antal forudgående behandlinger (interval) Mediant antal hudrettede behandlinger (interval) Mediant antal systemiske behandlinger (interval) MF, n (%)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ADCETRIS in one or more subsets of the paediatric population in the treatment of Hodgkin lymphoma and treatment of anaplastic large cell lymphoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Adcetris i en eller flere undergrupper af den pædiatriske population i behandlingen af Hodgkins lymfom og behandling af anaplastisk storcellet lymfom (se pkt.
English: A best overall response of CR was reported for 7 patients (12%); PR was reported for 23 patients (38%).
Danish: CR blev rapporteret som bedste samlede respons for 7 patienter (12 %), og PR blev rapporteret for 23 patienter (38 %).
English: Infection a, upper respiratory tract infection Infection a, upper respiratory tract infection
Danish: Infektion a, infektion i de øvre luftveje
English: Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations (see section 5.2).
Danish: Tilgængelige data tyder på, at MMAE-clearance kan påvirkes af svært nedsat nyrefunktion, nedsat leverfunktion og ved lav serumalbumin-koncentration (se pkt.
English: Febrile neutropenia reported in < 1% of the patients (see section 4.2).
Danish: Febril neutropeni blev rapporteret for < 1 % af patienterne (se pkt.
English: Forty-six (46) patients with CD30-expressing haematologic malignancies were evaluable of the 52 patients who received 1.8 mg/kg of brentuximab vedotin every 3 weeks as part of a phase 1, single-arm, open-label, multicenter cardiac safety study.
Danish: Seksogfyrre (46) patienter med hæmatologiske maligne sygdomme, der udtrykker CD30, kunne vurderes ud af de 52 patienter, der fik 1,8 mg/kg brentuximab vedotin hver 3. uge som en del af et fase 1, enkelt-armet, open-label, multicenter-studie af kardiel sikkerhed.
English: Grade 3 neutropenia was reported in 18% and Grade 4 neutropenia was reported in 47% of patients.
Danish: Grad 3 neutropeni blev rapporteret hos 18 %, og Grad 4 neutropeni blev rapporteret hos 47 % af patienterne.
English: Peripheral sensory neuropathy, peripheral motor neuropathy a,
Danish: Perifer sensorisk neuropati, perifer motorisk neuropati a,
English: Phase 1 included 3 r/r HL patients treated at 1.4 mg/kg and 9 patients (7 r/r HL and 2 sALCL) treated at 1.8 mg/kg.
Danish: Fase 1 inkluderede 3 patienter med r/r HL, som blev behandlet med 1,4 mg/kg, og 9 patienter (7 med r/r HL og 2 med sALCL), som blev behandlet med 1,8 mg/kg.
English: have severe and persistent stomach pain, with or without nausea and vomiting, as these may be symptoms of a serious and potentially fatal condition known as pancreatitis (inflammation of the pancreas).
Danish: - har alvorlige og vedvarende mavesmerter med eller uden kvalme og opkastning, da disse kan være symptomer på en alvorlig og måske dødelig tilstand kendt som pancreatitis (betændelse i bugspytkirtlen).
English: There is limited experience in patients with renal and hepatic impairment.
Danish: Der er begrænset erfaring med patienter med nedsat nyre- og leverfunktion.
English: However, results of repeat-dose toxicity studies in rats indicate the potential for brentuximab vedotin to impair male reproductive function and fertility.
Danish: Men resultaterne af toksicitetsstudier ved gentagen dosis hos rotter indicerer muligheden for, at brentuximab vedotin kan hæmme mandens reproduktivitetsfunktion og fertilitet.
English: Not estimable.
Danish: Kunne ikke vurderes.
English: Men being treated with this medicine are advised to have sperm samples frozen and stored before treatment.
Danish: Mænd, der behandles med dette lægemiddel, rådes til at få nedfrosset og opbevaret spermprøver før behandlingen.
English: Metabolism and nutrition disorders Very common:
Danish: Metabolisme og ernæring Meget almindelig:
English: The analyses showed a consistent trend towards benefit for patients who received ADCETRIS compared with patients who received placebo with the exception of patients ≥65 years of age (n = 8).
Danish: Analyserne viste konsekvent en tendens til fordel for de patienter, der fik ADCETRIS, sammenlignet med de patienter, der fik placebo, med undtagelse af patienter ≥ 65 år (n = 8).
English: Patients with a diagnosis of mycosis fungoides [MF] or primary cutaneous anaplastic large cell lymphoma [pcALCL] were considered eligible for the study.
Danish: Patienter med diagnosen Mycosis Fungoides [MF] eller primært kutant anaplastisk storcellelymfom [pcALCL] blev anset for at være egnede til studiet.
English: Treatment response was assessed by spiral CT of chest, neck, abdomen and pelvis; PET scans and clinical data.
Danish: Behandlingsrespons blev vurderet ved spiral CT-scanning af thorax, hals, abdomen og pelvis; PET-scanninger og kliniske data.
English: The maximal recommended dose is 180 mg.
Danish: Den maksimale anbefalede dosis er 180 mg.
English: Because of the CD30-targeted mechanism of action brentuximab vedotin is able to overcome chemo-resistance as CD30 is consistently expressed in patients who are refractory to multi-agent chemotherapy, irrespective of prior transplant status.
Danish: Den CD30 målrettede virkningsmekanisme gør brentuximab vedotin i stand til at overvinde kemo-resistens, da CD30 konstant udtrykkes hos patienter, som er refraktær over for flerstofs kemoterapi, uanset forudgående transplantationsstatus.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på hætteglassets etiket og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Serious infections such as pneumonia, staphylococcal bacteraemia, sepsis/septic shock (including fatal outcomes) and herpes zoster, cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS.
Danish: Alvorlige infektioner som pneumoni, stafylokok-bakteriæmi, sepsis/septisk shock (inklusive dødelige tilfælde) og herpes zoster, cytomegalovirus (CMV) (reaktivering) samt opportunistiske infektioner som fx Pneumocystis jiroveci pneumoni og oral candidiasis er rapporteret hos patienter behandlet med ADCETRIS.
English: Adcetris is a white to off-white cake or powder for concentrate for solution for infusion provided in a glass vial.
Danish: Adcetris er en hvid til gullig substans eller pulver til koncentrat til infusionsvæske, opløsning, som leveres i et hætteglas af glas.
English: Men being treated with this medicine are advised not to father a child during treatment and for up to 6 months following the last dose.
Danish: Mænd, der behandles med dette lægemiddel, tilrådes ikke at avle børn under behandlingen og i op til 6 måneder efter den sidste dosis af medicinen.
English: ADCETRIS is an antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 [IgG1], produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE).
Danish: ADCETRIS er et antistof-lægemiddelkonjugat bestående af et CD30-rettet monoklonalt antistof (rekombinant kimerisk immunglobulin G1 [IgG1], fremstillet ved rekombinant DNA-teknologi i ovarieceller fra kinesiske hamstere), som er kovalent bundet til antimikrotubulus-midlet monomethylauristatin E (MMAE).
English: Safety was evaluated in a phase 1/2 study in paediatric patients aged 7-17 years of age (n = 36) with relapsed or refractory (r/r) HL and sALCL (see section 5.1).
Danish: Sikkerheden blev evalueret i et fase 1/2-studie med pædiatriske patienter i alderen 7-17 år (n = 36) med recidiverende eller refraktær (r/r) HL og sALCL (se pkt.
English: • B symptoms at pre-ASCT relapse
Danish: • B-symptomer ved recidiv før ASCT
English: The efficacy and safety of ADCETRIS were evaluated in two additional open-label studies in 108 patients with relapsed CD30+ CTCL (including MF and pcALCL as well as SS, LyP and mixed CTCL histology), regardless of CD30 expression level.
Danish: ADCETRIS virkning og sikkerhed blev evalueret i to andre åbne studier med 108 patienter med recidiverende CD30+ CTCL (inkluderende MF og pcALCL samt SS, LyP og blandet CTCLhistologi., uafhængigt af graden af CD30-ekspression.
English: See Table 6 for patient characteristics.
Danish: Tabel 6 viser patientkarakteristika.
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret den
English: In non-clinical studies, brentuximab vedotin treatment has resulted in testicular toxicity, and may alter male fertility.
Danish: I ikke-kliniske studier har brentuximab vedotin-behandling resulteret i testikulær toksicitet og kan påvirke mænds fertilitet.
English: Serious adverse drug reactions occurred in 12% of patients.
Danish: Alvorlige bivirkninger forekom hos 12 % af patienterne.
English: Final Study Report by: Q1 2021
Danish: Endelig studierapport: 1. kvartal 2021
English: When you first receive this medicine and during the course of treatment, tell your doctor if you: have confusion, trouble thinking, memory loss, blurred or loss of vision, decreased strength, decreased control or sensation in one arm or leg, a change in the way of walking, or loss of balance, as these may be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
Danish: Når du begynder at få denne medicin og under behandlingsforløbet skal du fortælle lægen, hvis du: - er konfus, har problemer med at tænke, hukommelsestab, uklart eller tab af synet, nedsat styrke, nedsat kontrol eller følelse i en arm eller et ben, en forandring i måden at gå på eller tab af balance, da dette kan være symptomer på en alvorlig og måske dødelig hjernesygdom, der kaldes progressiv multifokal leukoencefalopati (PML).
English: 15.8 months (95% CI [8.5, -])
Danish: 15,8 måneder (95% CI [8,5; -])
English: In patients receiving ADCETRIS combination therapy, serious adverse reactions occurred in 36% of patients.
Danish: Hos patienter, der fik ADCETRIS som kombinationbehandling, forekom der alvorlige bivirkninger hos 36 % af patienterne.
English: 52 years (14-76)
Danish: 52 år (14-76)
English: Adjusted p-value
Danish: Justeret p-værdi
English: In the clinical trial of ADCETRIS as combination therapy, serious infections including opportunistic infections occurred in 15% of patients; sepsis, neutropenic sepsis, septic shock or bacteraemia occurred in 4% of the patients.
Danish: I det kliniske forsøg med ADCETRIS som kombinationsbehandling forekom der alvorlige infektioner, herunder opportunistiske infektioner, hos 15 % af patienterne; sepsis, neutropenisk sepsis, septisk shock eller bakteriæmi forekom hos 4 % af patienterne.
English: Maximum concentrations of brentuximab vedotin ADC were typically observed at the end of infusion or the sampling timepoint closest to the end of infusion.
Danish: Maksimumkoncentrationer af brentuximab vedotin ADC blev typisk observeret ved slutningen af en infusion eller på det prøveudtagningstidspunkt, der lå nærmest slutningen af infusionen.
English: Of the 35 patients (33%) who had B symptoms at baseline, 27 patients (77%) experienced resolution of all B symptoms at a median time of 0.7 months from initiation of ADCETRIS.
Danish: Ud af de 35 patienter (33 %), der havde B-symptomer ved baseline, oplevede 27 patienter (77 %) ophør af alle B-symptomer med mediantid på 0,7 måneder fra initiering af ADCETRIS.
English: A phase 4 single-arm study was conducted in patients with relapsed or refractory HL (n = 60) who had received at least one prior chemotherapeutic regimen and at the time of treatment initiation with ADCETRIS were not considered candidates for SCT or multiagent chemotherapy.
Danish: Der blev gennemført et enkelt-armet fase 4-studie med patienter med recidiverende eller refraktært HL (n = 60), som havde fået mindst et tidligere kemoterapi-regime, og som på tidspunktet for indledning af behandling med ADCETRIS ikke blev anset for at være kandidater til ASCT eller flerstofskemoterapi.
English: Adcetris is used to treat cutaneous T-cell lymphoma (CTCL) in patients who have previously received at least one medicine that travels through the bloodstream.
Danish: Adcetris bruges til at behandle kutant T-cellelymfom (CTCL) hos patienter, som tidligere har fået mindst ét lægemiddel, der optages via blodbanen.
English: Febrile neutropenia was reported in 21% of the patients who did not receive primary prophylaxis with G-CSF (see section 4.2).
Danish: Febril neutropeni blev rapporteret hos 21 % af de patienter, der ikke fik primær profylakse med G-CSF (se pkt.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: ADCETRIS may have a moderate influence on the ability to drive and use machines (e.g. dizziness), see section 4.8.
Danish: ADCETRIS påvirker muligvis i moderat grad evnen til at føre motorkøretøj og betjene maskiner (f.eks. svimmelhed), se pkt.
English: Therefore, co-administration of brentuximab vedotin with strong CYP3A4 and P-gp inhibitors may increase the incidence of neutropenia.
Danish: Derfor kan samtidig administration af brentuximab vedotin og stærke CYP3A4 og P-gp-hæmmere øge forekomsten af neutropeni.
English: The results in the intent-to-treat (ITT) population showed a statistically significant improvement in modified PFS for ADCETRIS+ AVD, with a stratified hazard ratio of 0.770 (95% CI, 0.603; 0.983, p = 0.035), indicating a 23% reduction in the risk of modified PFS events for ADCETRIS+ AVD versus ABVD.
Danish: Resultaterne i ITT-populationen (intent-to-treat) viste en statistisk signifikant forbedring i modificeret PFS for ADCETRIS + AVDmed en stratificeret hazard ratio på 0,770 (95 % CI, 0,603; 0,983, p =0,035), hvilket indikerer en 23 % reduktion i risikoen for modificerede PFShændelser for ADCETRIS + AVD kontra ABVD.
English: Prior chemotherapy Regimens (range) Histologically confirmed CD30-expressing disease Anaplastic lymphoma kinase (ALK)-negative disease Disease characteristics
Danish: Tidligere kemoterapi-regimer (område) Histologisk bekræftet CD30-udtrykkende sygdom Anaplastisk lymfom kinase (ALK)-negativ sygdom Sygdomskarakteristika
English: Of the patients treated, 9 responding patients went on to receive an allogeneic stem cell transplant (SCT) and 9 responding patients went on to autologous SCT.
Danish: Af de behandlede patienter fortsatte 9 responderende patienter med at modtage en allogen stamcelletransplantation (ASCT), og 9 responderende patienter fortsatte med autolog ASCT.
English: The presence of antibodies to brentuximab vedotin did not correlate with a clinically meaningful reduction in serum brentuximab vedotin levels and did not result in a decrease in the efficacy of brentuximab vedotin.
Danish: Tilstedeværelsen af antistoffer over for brentuximab vedotin korrelerede ikke med en klinisk meningsfyldt reduktion af brentuximab vedotin-niveauer i serum og medførte ikke et fald i virkningen af brentuximab vedotin.
English: Population pharmacokinetic analysis indicated that the pharmacokinetics of ADCETRIS in combination with AVD were consistent to that in monotherapy.
Danish: Farmakokinetisk populationsanalyse indikerede, at farmakokinetikken for ADCETRIS i kombination med AVD svarede til den for monoterapi.
English: Additionally, the population pharmacokinetics of brentuximab vedotin in combination with AVD were examined, including data from 661 patients up to 82 years old (42 patients ≥ 65-< 75 and 17 patients ≥ 75 years of age).
Danish: Desuden blev brentuximab vedotins populationsfarmakokinetik i kombination med AVD undersøgt, inklusive data fra 661 patienter op til 82 år (42 patienter ≥ 65-< 75 og 17 patienter ≥ 75 år).
English: In patients with Stage IV disease for whom no extranodal disease was reported, no benefit has been shown at time of analysis ([n = 85] [HR = 1.49, 95% CI (0.51, 4.31)]).
Danish: Hos patienter med stadie IV-sygdom, for hvem der ikke blev rapporteret ekstranodal sygdom viste resultaterne ingen fordel på analysetidspunktet ([n = 85] [HR = 1,49; 95 % CI (0,51,;4,31)]).
English: Per IRF, the objective response rate (ORR) in the ITT population was 50% (95% CI, 37; 63%).
Danish: IRF-vurdering var den objektive responsrate (ORR) i ITTgruppen 50 % (95 % CI [37 %, 63 %]).
English: Table 3: Adverse reactions to ADCETRIS
Danish: Tabel 3: Bivirkninger ved ADCETRIS
English: In clinical trials, patients were periodically tested for antibodies to brentuximab vedotin using a sensitive electrochemiluminescent immunoassay.
Danish: I kliniske forsøg blev patienter periodisk testet for antistoffer over for brentuximab vedotin ved hjælp af en følsom elektrokemiluminescens-immunanalyse.
English: Of the patients treated, 8 responding patients went on to receive an allogeneic SCT.
Danish: Ud af de behandlede patienter fortsatte 8 responderende patienter med at få allogen ASCT.
English: Patient characteristics n = 102
Danish: Patient-katakteristika n = 102
English: Adcetris contains the active substance brentuximab vedotin, an anti-cancer agent, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells.
Danish: Adcetris indeholder det aktive stof brentuximab vedotin, et middel mod kræft, som består af et monoklonalt antistof bundet til et stof, der skal dræbe kræftceller.
English: Hepatotoxicity in the form of elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) has been reported with ADCETRIS.
Danish: Levertoksicitet i form af forhøjet alaninaminotransferase (ALAT) og aspartataminotransferase (ASAT) er rapporteret med ADCETRIS.
English: Complete blood counts should be monitored prior to administration of each dose.
Danish: Fuldblodstal skal monitoreres før administration af hver enkelt dosis.
English: Systemic anaplastic large cell lymphoma
Danish: Systemisk anaplastisk storcellet lymfom
English: 24.1 months (95% CI [11.5, -])
Danish: 24,1 måneder (95% CI [11,5; -])
English: The most common prior systemic therapies in the ITT population were chemotherapy (71%), immunotherapy (43%) and bexarotene (38%).
Danish: De mest almindelige forudgående systemiske behandlinger i ITT-populationen var kemoterapi (71 %), immunterapi (43 %) og bexaroten
English: The median number of cycles was 8.5 (range, 2 to 30 cycles).
Danish: Det mediane antal serier var 8,5 (interval 2 til 30 serier).
English: Patients were treated with 1.8 mg/kg of ADCETRIS every 3 weeks.
Danish: Patienterne blev behandlet med 1,8 mg/kg ADCETRIS hver 3. uge.
English: The ORR per IRF assessment was 86% (50 of 58 patients in the ITT set).
Danish: IRF-vurdering var på 86 % (50 af 58 patienter i ITT-gruppen).
English: Calculation to determine the total ADCETRIS dose (mL) to be further diluted (see section 4.2):
Danish: Beregning til bestemmelse af den totale ADCETRIS-dosis (ml) for videre fortynding (se pkt.
English: Patients with a concurrent diagnosis of systemic ALCL, Sezary syndrome and other nonHodgkin lymphoma (except for lymphomatoid papulosis [LyP]) were excluded from this study.
Danish: Patienter, der samtidig havde diagnosen systemisk ALCL, Sézarys syndrom og andre non-Hodgkins lymfomer (bortset fra lymfomatoid papulose [LyP]) eller blev udelukket fra dette studie.
English: Study SGN35-006 (Retreatment study)
Danish: Studie SGN35-006 (genbehandlingsstudie)
English: For single use only
Danish: Kun til engangsbrug.
English: ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.
Danish: ADCETRIS skal seponeres, hvis diagnosen akut pancreatitis bekræftes.
English: Median time from HL diagnosis to first dose (range)
Danish: Mediantid fra HL-diagnose til første dosis (interval)
English: Alanine aminotransferase (ALT) increased
Danish: Forhøjet alaninaminotransferase (ALAT)
English: Of the 17 patients (29%) who had B symptoms at baseline, 14 patients (82%) experienced resolution of all B symptoms in a median time from initiation of ADCETRIS of 0.7 months.
Danish: Ud af de 17 patienter (29 %), der havde B-symptomer ved baseline, oplevede 14 patienter (82 %) ophør af alle B-symptomer med en median tid på 0,7 måneder fra initiering af ADCETRIS.
English: There was a higher incidence of infusion-related reactions observed in patients with antibodies to brentuximab vedotin relative to patients who tested transiently positive or negative.
Danish: Der blev observeret en højere forekomst af infusionsrelaterede reaktioner hos patienter med antistoffer over for brentuximab vedotin i forhold til patienter, som blev testet forbigående positive eller negative i laboratorietests.
English: Adverse events led to treatment discontinuation in 24% of patients receiving ADCETRIS.
Danish: Bivirkninger medførte seponering af behandlingen for 24 % af de patienter, der fik ADCETRIS.
English: Co-administration of brentuximab vedotin did not affect the plasma exposure of AVD.
Danish: Samtidig administration af brentuximab vedotin påvirkede ikke plasmaeksponeringen for AVD.
English: No pulmonary toxicity or fatal events were reported with brentuximab vedotin + AVD.
Danish: Der blev ikke rapporteret nogen hændelser med lungetoksicitet eller letale hændelser med brentuximab vedotin + AVD.