FrancophonIA/ELRC3.0 huggingface dataset:
English: Best clinical response (n = 58 )
Danish: Bedste kliniske respons (n = 58 )
English: Direct the stream toward the wall of the vial and not directly at the cake or powder.
Danish: Ret strømmen mod hætteglassets væg og ikke direkte mod substancen eller pulveret.
English: Patients also had a higher incidence of arthralgia, Grade 3 anaemia, and back pain compared to patients observed in the combined pivotal phase 2 studies.
Danish: Patienterne havde også en højere forekomst af artralgi, Grad 3 anæmi samt rygsmerter sammenlignet med patienter observeret i de kombinerede pivotale fase 2-studier.
English: In the physician's choice arm, the median duration of treatment (number of cycles) for patients receiving bexarotene was approximately 16 weeks (5.5 cycles) and 11 weeks (3 cycles) for patients receiving methotrexate.
Danish: I armen med lægens valg var den mediane varighed af behandlingen (antallet af behandlingsserier) for patienter, som fik bexaroten, cirka 16 uger (5,5 behandlingsserier) og 11 uger (3 behandlingsserier) for patienter, som fik methotrexat.
English: In vitro studies using human liver microsomes indicate that MMAE inhibits only CYP3A4/5 at concentrations much higher than was achieved during clinical application.
Danish: In vitro-studier med humane levermikrosomer indikerer, at MMAE kun hæmmer CYP3A4/5 ved koncentrationer, der er meget højere end dem der var opnået under klinisk applikation.
English: Minimal to no accumulation of ADC was observed with multiple doses at the every 3-week schedule, consistent with the terminal half-life estimate.
Danish: Der observeredes minimal til ingen akkumulation af ADC ved multiple doser ved hver 3-ugers plan, overensstemmende med det terminale halveringstidsestimat.
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil mindst en gang om året vurdere nye oplysninger om, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal.
Danish: PML er en sjælden demyelineringssygdom i centralnervesystemet, der stammer fra reaktivering af latent JCV, ofte med dødelig udgang.
English: Best clinical response (n = 102 )
Danish: Bedste kliniske respons (n = 102 )
English: For refractory disease, or upon progression or relapse after frontline therapy.
Danish: For refraktær sygdom eller efter progression eller recidiv efter primær behandling.
English: There are no data as to whether brentuximab vedotin or its metabolites are excreted in human milk.
Danish: Der foreligger ingen data for, hvorvidt brentuximab vedotin eller dets metabolitter udskilles i human mælk.
English: Approximately 24% of the total MMAE administered as part of the ADC during a brentuximab vedotin infusion was recovered in both urine and faeces over a 1-week period.
Danish: Cirka 24 % af det totale MMAE administreret som en del af ADC under en brentuximab vedotin-infusion blev genfundet i både urin og fæces over en 1-uges periode.
English: The efficacy results are shown in Table 7.
Danish: Virkningsresultaterne er vist i tabel 7.
English: Patients with known cerebral/meningeal disease, including history of PML were excluded from the study.
Danish: Patienter med kendt cerebral/meningeal sygdom, herunder PML i anamnesen, blev udelukket fra studiet.
English: ORR4 was 50% and 75% in the ADCETRIS arm versus 10.2% and 20% in the physician's choice arm for MF and pcALCL, respectively.
Danish: ORR4 var 50 % og 75 % i ADCETRIS-armen kontra henholdsvis 10,2 % og 20 % for MF og pcALCL i armen med lægens valg.
English: Total ADCETRIS dose (mL) to be administered
Danish: Total ADCETRIS-dosis (ml) der skal administreres
English: Reduce dose to 0.9 mg/kg up to a maximum of 90 mg every 2 weeks
Danish: Reducer dosis til 0,9 mg/kg op til højst 90 mg hver 2. uge
English: Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures.
Danish: Patientevaluering kan inkludere fysisk undersøgelse, laboratorieundersøgelser af serum-amylase og serum-lipase samt abdominal billeddiagnostik, såsom ultralyd og andre passende diagnostiske tiltag.
English: This substance is delivered to cancer cells by the monoclonal antibody.
Danish: Stoffet føres til kræftcellerne af det monoklonale antistof.
English: Patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately 1 year) (see section 5.1).
Danish: Patienter, der opnår stabil sygdom eller bedre, bør have mindst 8 behandlingsserier og op til højst 16 behandlingsserier (cirka 1 år) (se pkt.
English: ADCETRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents.
Danish: ADCETRIS bør kun administreres under kontrol af en læge, med erfaring i anvendelse af lægemidler mod cancer.
English: All patients had a histologically confirmed CD30-expressing disease.
Danish: Alle patienter havde en sygdom med histologisk bekræftet CD30-ekspression.
English: Interaction with medicinal products metabolised through CYP3A4 route (CYP3A4 inhibitors/inducers)
Danish: Interaktion med lægemidler, der metaboliseres via CYP3A4 (CYP3A4-hæmmere/induktorer)
English: Patients with rapidly proliferating tumour and high tumour burden are at risk of tumour lysis syndrome.
Danish: Patienter med hurtigtvoksende tumor og høj tumorbelastning er i risiko for tumorlyse-syndrom.
English: Median per IRF
Danish: Median pr. IRF
English: Grade 2 (interfering with function but not with activities of daily living) or
Danish: Grad 2 (påvirker funktionen, men ikke almindelige dagligdags aktiviteter)
English: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 13,2 mg natrium pr. hætteglas, svarende til 0,7 % af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: Hodgkin lymphoma and systemic anaplastic large cell lymphoma are both types of cancer of the white blood cells.
Danish: Hodgkins lymfom og systemisk anaplastisk storcellet lymfom er begge kræfttyper, der rammer de hvide blodlegemer.
English: Infusion-related reactions a, chills
Danish: Infusionsrelaterede reaktioner a, kulderystelser
English: For further efficacy results see Table 10.
Danish: For yderligere virkningsresultater henvises til Tabel 10.
English: Exposures were approximately dose proportional with a trend observed for lower ADC exposures at lower ages/ body weights in the study population.
Danish: Eksponeringer var tilnærmeligt dosisproportionale i studiets population med en tendens til lavere ADC-eksponeringer ved lavere alder/kropsvægt.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: The median time from onset to resolution or improvement for all events ranged from 16 to 23.4 weeks.
Danish: Den mediane tid fra begyndelsen til ophøret eller bedringen for alle hændelser lå i intervallet 16 til 23,4 uger.
English: Patients should be monitored closely for fever and managed according to best medical practice if febrile neutropenia develops.
Danish: Patienterne skal nøje monitoreres for feber og behandles efter bedste medicinske praksis, dersom der opstår febril neutropeni.
English: In the first cycle, higher MMAE exposure was associated with an absolute decrease in neutrophil count.
Danish: Ved den første behandlingsserie, var højere MMAE eksponering associeret med et absolut fald i neutrofile værdier.
English: The recommended diluent volume is 150 mL.
Danish: Det anbefalede diluentvolumen er 150 ml.
English: feel tired, have frequent urination, increased thirst, increased appetite with unintended weight loss, or irritability (hyperglycaemia) have kidney or liver problems.
Danish: - føler dig træt, har hyppig vandladning, øget tørst, øget appetit med utilsigtet vægttab eller irritabilitet (hyperglykæmi) - har nyre- eller leverproblemer.
English: Binding of the ADC to CD30 on the cell surface initiates internalisation of the ADC-CD30 complex, which then traffics to the lysosomal compartment.
Danish: Binding af ADC til CD30 på celleoverfladen initierer internalisering af ADC-CD30-komplekset, som derefter bevæger sig til det lysosomale rum.
English: Timing of the modified event was the date of the first PET scan post completion of first-line therapy demonstrating the absence of complete response (CR), defined as Deauville score of ≥3.
Danish: Timingen for den modificerede hændelse var datoen for den første PET-scanning efter fuldførelse af førstelinjebehandling, som påviste fravær af komplet respons (CR), defineret som Deauville-score på ≥ 3.
English: Of the recovered MMAE, approximately 72% was recovered in the faeces.
Danish: Af det genfundne MMAE blev cirka 72 % genfundet i fæces.
English: Relapsed or refractory sALCL
Danish: Recidiverende eller refraktært sALCL
English: Reconstituted/diluted solution: Use immediately or store in a refrigerator (2 C-8 °C) and use within 24 hours.
Danish: Opblandet/fortyndet opløsning: Skal bruges omgående efter opblanding eller opbevares i køleskab (2 °C-8 °C) og bruges inden for 24 timer.
English: This medicine has been given ‘conditional approval'.
Danish: Dette lægemiddel er godkendt under ”betingede omstændigheder”.
English: Type I glass vial with a butyl rubber stopper and an aluminium/plastic flip-off seal, containing 50 mg powder.
Danish: Type I glas-hætteglas med en prop af butylgummi og en aluminium/plast- forsegling, der kan vippes af, indeholdende 50 mg pulver.
English: Older patients who received G-CSF primary prophylaxis had lower incidence of neutropenia and febrile neutropenia than those who did not receive G-CSF primary prophylaxis.
Danish: Ældre patienter, som fik G-CSF som primær profylakse, havde en lavere forekomst af neutropeni og febril neutropeni end dem, der ikke fik G-CSF som primær profylakse.
English: The upper 90% confidence interval (CI) around the mean effect on QTc was < 10 msec at each of the Cycle 1 and Cycle 3 post-baseline time points.
Danish: Det øverste 90 % konfidensinterval (CI) omkring den gennemsnitlige effekt på QTc var < 10 msek ved hvert af tidspunkterne i behandlingsserie 1 og behandlingsserie 3 efter baseline.
English: Patients should be monitored for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paraesthesia, discomfort, a burning sensation, neuropathic pain or weakness.
Danish: Patienterne bør monitoreres for symptomer på neuropati, så som hypoæstesi, hyperæstesi, paraæstesi, ubehag, en brændende fornemmelse, neuropatiske smerter eller svaghed.
English: The most commonly reported opportunistic infections were herpes viral infections.
Danish: De mest almindelige opportunistiske infektioner, der blev rapporteret, var herpesvirusinfektioner.
English: Patients should be closely monitored for new or worsening neurological, cognitive, or behavioural signs or symptoms, which may be suggestive of PML.
Danish: Patienterne bør nøje monitoreres for nye eller forværrede neurologiske, kognitive eller adfærdsmæssige tegn eller symptomer, der kan tyde på PML.
English: Adcetris is used to treat patients with advanced classical Hodgkin lymphoma who have not had treatment before.
Danish: Adcetris bruges til at behandle patienter med fremskreden klassisk Hodgkins lymfom, som ikke er blevet behandlet før.
English: Toxic epidermal necrolysis was not reported in the combination therapy setting.
Danish: Toksisk epidermal nekrolyse blev ikke rapporteret i forbindelse med kombinationsbehandling.
English: Store in a refrigerator (2 °C-8 °C).
Danish: Opbevares i køleskab (2 °C-8 °C).
English: Patients who discontinued due to peripheral neuropathy received a median of 8 doses of ADCETRIS+AVD (A+AVD) before discontinuation of one or more agents.
Danish: Patienter, som seponerede behandlingen på grund af perifer neuropati, fik en median af 8 doser med ADCETRIS+AVD (A+AVD), inden et eller flere af stofferne blev seponeret.
English: The frequency of febrile neutropenia was 11% in patients who received primary prophylaxis with G-CSF.
Danish: Hyppigheden af febril neutropeni var 11 % hos patienter, der fik primær profylakse med G-CSF.
English: Classical HL, sALCL and subtypes of CTCL (including MF and pcALCL) express CD30 as an antigen on the surface of their malignant cells.
Danish: Klassisk HL, sALCL og undertyper af CTCL (herunder MF og pcALCL) præsenterer CD30 som et antigen på overfladen af deres maligne celler.
English: Febrile neutropenia
Danish: Febril neutropeni
English: Tell your doctor if you have kidney or liver problems as your doctor may lower your starting dose to 0.9 mg/kg or may not recommend Adcetris.
Danish: Fortæl det til lægen, hvis du har nyre- eller leverproblemer, da lægen så muligvis vil nedsætte din startdosis til 0,9 mg/kg eller fraråde behandling med Adcetris.
English: DO NOT SHAKE.
Danish: MÅ IKKE RYSTES.
English: Combined use of bleomycin and ADCETRIS causes pulmonary toxicity (see section 4.5).
Danish: Kombineret anvendelse af bleomycin og ADCETRIS medfører pulmonal toksicitet (se pkt.
English: (95% CI [0.40, 0.81]) Stratified log-rank test p=0.001
Danish: (95 % CI [0,40; 0,81]) Stratificeret log-ranktest p = 0,001
English: - are currently using bleomycin, an anti-cancer agent
Danish: - for øjeblikket får bleomycin, et middel mod kræft.
English: Relapsed or refractory HL
Danish: Recidiverende eller refraktært HL
English: Median Overall survival
Danish: Median Samlet overlevelse
English: Patients with pcALCL received either prior radiation therapy or at least 1 prior systemic therapy and patients with MF received at least 1 prior systemic therapy.
Danish: Patienter med pcALCL fik enten forudgående strålebehandling eller mindst 1 forudgående systemisk behandling, og patienter med MF fik mindst 1 forudgående systemisk behandling.
English: Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (17%), pyrexia (6%), and neutropenia (3%).
Danish: Alvorlige bivirkninger, der forekom hos ≥ 3 % af patienterne, omfattede febril neutropeni (17 %), pyreksi (6 %) og neutropeni (3 %).
English: Median age, years (range)
Danish: Mediane alder, år (interval)
English: In vivo data in animals and humans suggest that only a small fraction of MMAE released from brentuximab vedotin is metabolised.
Danish: In vivo-data hos dyr og mennesker tyder på, at kun en lille fraktion af MMAE frigjort fra brentuximab vedotin metaboliseres.
English: Eight HL patients and 9 sALCL patients went on to receive SCT following treatment with ADCETRIS.
Danish: Otte patienter med HL og 9 patienter med sALCL fortsatte til at modtage SCT efter behandlingen med ADCETRIS.
English: Tell your doctor if you are taking any other medicines, if you have taken any recently, or if you start taking new ones.
Danish: Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Neutropenia a, anaemia, febrile neutropenia
Danish: Neutropeni a, anæmi, febril neutropeni
English: Calculation to determine the total number of ADCETRIS vials needed:
Danish: Beregning til bestemmelse af det totale antal ADCETRIS-hætteglas, der skal til:
English: Hyperglycaemia has been reported during clinical trials in patients with an elevated Body Mass Index (BMI) with or without a history of diabetes mellitus.
Danish: Hyperglykæmi er rapporteret i kliniske forsøg hos patienter med forhøjet Body Mass Index (BMI) med eller uden diabetes mellitus i anamnesen.
English: The other chemotherapy medicines are doxorubicin, vinblastine and dacarbazine.
Danish: De andre kemoterapi-lægemidler er doxorubicin, vinblastin og dacarbazin.
English: ADCETRIS should be held for any suspected case of PML.
Danish: ADCETRIS bør tilbageholdes ved eventuelle mistænkte tilfælde af PML.
English: Pancreatitis acute
Danish: Akut pancreatitis
English: Hodgkin lymphoma
Danish: Hodgkins lymfom
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om rekonstitution og fortynding af lægemidlet før administration, se pkt.
English: While the presence of antibodies to brentuximab vedotin does not necessarily predict the development of an IRR, there was a higher incidence of IRRs observed in patients with persistently positive anti-drug antibodies (ADA) relative to patients with transiently positive ADA and never positive ADA.
Danish: Selv om tilstedeværelsen af antistoffer over for brentuximab vedotin ikke nødvendigvis betyder udvikling af en IRR, blev der observeret en højere forekomst af IRR hos patienter med vedvarende positiv ADA (antistoffer mod lægemidlet) i forhold til patienter med forbigående positiv ADA og aldrig positiv ADA.
English: If you are breast-feeding, you should discuss with your doctor whether you should receive this medicine.
Danish: Hvis du ammer, skal du drøfte med lægen, om du skal have denne medicin.
English: Overall response rates for MF were 54-66%; pcALCL, 67%; SS, 50%; LyP, 92%; and mixed CTCL histology, 82-85%.
Danish: Den overordnede responsrate for MF var 54 - 66 %; pcALCL, 67 %; SS 50 %; LyP 92 % og blandet CTCL histologi
English: Date of renewal: 10 September 2018
Danish: Dato for første markedsføringstilladelse: 25. oktober 2012 Dato for seneste fornyelse: 10. september 2018
English: Modification of dose and schedule
Danish: Modificering af dosis og plan
English: If an IRR occurs, the infusion should be interrupted and appropriate medical management instituted.
Danish: Hvis der forekommer en IRR, skal infusionen afbrydes, og der skal iværksættes passende medicinsk behandling.
English: Response to treatment with ADCETRIS was assessed by Independent Review Facility (IRF) using the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007).
Danish: Respons på behandling med ADCETRIS blev evalueret af Independent Review Facility (IRF) ved brug af de reviderede responskriterier for malignt lymfom (Revised Response Criteria for Malignant Lymphoma) (Cheson, 2007).
English: Advanced (IIB-IVB pcALCL, n (%)
Danish: Tidlig (IA-IIA) Fremskreden (IIB-IVB pcALCL, n (%) Kun hud
English: MMAE exposures decreased after multiple doses of brentuximab vedotin with approximately 50% to 80% of the exposure of the first dose being observed at subsequent doses.
Danish: MMAE-eksponeringerne mindskes efter multiple doser brentuximab vedotin med cirka 50 % til 80 % af eksponeringen for den første dosis, der observeres ved efterfølgende doser.
English: Severity grade of neutropenia (signs and symptoms [abbreviated description of CTCAE a])
Danish: Sværhedsgrad ved neutropeni (tegn og symptomer [forkortet beskrivelse af CTCAE a])
English: General precautions
Danish: Generelle forholdsregler
English: The analysis indicated that MMAE clearance was 2-fold lower in patients with low serum albumin concentrations <3.0 g/dl compared with patients with serum albumin concentrations within the normal range.
Danish: Analysen tydede på, at MMAE-clearance var 2 gange lavere hos patienter med lav serum-albumin <3,0 g/dl sammenlignet med patienter med serum-albumin inden for normalområdet.
English: Complete remission (CR) was 33% (34 of 102 patients in the ITT set).
Danish: Komplet remission (CR) blev opnået hos 33 % (34 af 102 patienter i ITT-gruppen).
English: Adcetris contains sodium
Danish: Adcetris indeholder natrium
English: Percent Difference (95% CI)
Danish: Procent forskel (95% CI)
English: The ADC is eliminated by catabolism with a typical estimated CL and half life of 1.5 l/day and 4-6 days respectively.
Danish: ADC udskilles ved katabolisme med en typisk estimeret CL og halveringstid på henholdsvis 1,5 l/dag og 4-6 dage.
English: The efficacy of retreatment in patients who had previously responded (CR or PR) to treatment with ADCETRIS was evaluated in a phase 2, open-label, multicenter trial.
Danish: Virkningen af genbehandling hos patienter, som tidligere havde responderet (CR eller PR) på behandling med ADCETRIS, blev evalueret i et åbent fase 2-multicenterforsøg.
English: Results from these phase 1 studies and from the NPP experience showed, that in patients with relapsed or refractory HL without prior ASCT, clinically meaningful responses can be achieved as evidenced by an investigator-assessed, objective response rate of 54% and a complete remission rate of 22% after a median of 5 cycles of ADCETRIS.
Danish: Resultater fra disse fase 1-studier og erfaringerne fra NPP viste, at hos patienter med recidiverende eller refraktær HL uden forudgående ASCT, kan der opnås klinisk meningsfuldt respons med en objektiv responsrate på 54 % og en komplet remission rate på 22 %, vurderet ved investigator, efter en median på 5 behandlingsserier af ADCETRIS.
English: Pharmacotherapeutic group: Antineoplastic agents; other antineoplastic agents; monoclonal antibodies, ATC code: L01XC12
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler; andre antineoplastiske midler; monoklonale antistoffer, ATC-kode: L01XC12
English: In patients with relapsed or refractory HL or sALCL who were retreated with ADCETRIS (SGN35-006), the majority of patients (80%) also had improvement or resolution of their peripheral neuropathy symptoms at the time of last evaluation.
Danish: Hos patienter med recidiverende eller refraktær HL eller sALCL, som fik genbehandling med ADCETRIS (SGN35-006), opnåede størstedelen af patienterne (80 %) også bedring eller ophør af deres symptomer på perifer neuropati på tidspunktet for sidste evaluering.
English: In older patients (≥ 60 years of age; n = 83 [13%]), the incidence of adverse events was similar across treatment arms.
Danish: Hos ældre patienter (≥ 60 år; n = 83 [13 %]) var forekomsten af bivirkninger ens på tværs af behandlingsarme.
English: If an anaphylactic reaction occurs, administration of ADCETRIS should be immediately and permanently discontinued and appropriate medical therapy should be administered.
Danish: Hvis der forekommer en anafylaktisk reaktion, skal administrationen af ADCETRIS omgående og permanent seponeres, og der skal administreres passende medicinsk behandling.
English: The exposure of MMAE (as assessed by AUC14D between Cycle 1 and Cycle 3) appeared to decrease with time by approximately 50%.
Danish: Eksponeringen for MMAE (som vurderet af AUC14D mellem behandlingsserie 1 og behandlingsserie 3) faldt tilsyneladende med tiden med cirka 50 %.
English: Percent Difference (95% CI) p-value
Danish: Procent forskel (95% CI) p-værdi
English: The median time from onset to resolution or improvement of peripheral neuropathy events was 10 weeks (ranged from 0 weeks to 139 weeks).
Danish: Den mediane tid fra begyndelsen til ophøret eller bedringen af perifer neuropati var 10 uger (i intervallet 0 uger til 139 uger).
English: The median overall survival (OS) is 40.5 months (the median observation time (time to death or last contact) from first dose was 35.1 months (range 1.8 to 72.9+ months).
Danish: Den mediane samlede overlevelse (OS) er 40,5 måneder (den mediane observationstid (tid indtil død eller sidste kontakt) fra første dosis var 35,1 måneder (interval 1,8 til 72,9+ måneder).
English: Intent to Treat (ITT) Population
Danish: ITT-population (intent-to-treat)
English: The elimination of MMAE was limited by its rate of release from ADC, typical apparent CL and half life of MMAE was 19.99 l/day and 3-4 days respectively.
Danish: Udskillelsen af MMAE var begrænset af dets frisættelseshastighed fra ADC, typisk var tydelig CL og halveringstid for MMAE henholdsvis 19,99 l/dag og 3-4 dage.