FrancophonIA/ELRC3.0 huggingface dataset:
English: See section 2 for further information about sodium.
Danish: 2 for yderligere oplysninger om natrium.
English: Alternatively, treatment may be started at the last tolerated dose (see section 5.1).
Danish: Alternativt kan behandlingen startes med den sidst tolererede dosis (se pkt.
English: The safety profile of ADCETRIS is based on available clinical trial data, the Named Patient Program (NPP), and post-marketing experience to date.
Danish: ADCETRIS sikkerhedsprofil er baseret på de tilgængelige data fra kliniske forsøg, udleveringstilladelser (Named Patient Program (NPP)) og postmarketing-erfaringen til dato.
English: You should not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs the potential risk to the unborn baby.
Danish: Du må ikke bruge denne medicin, hvis du er gravid, medmindre du og din læge beslutter, at den gavn, du har af medicinen, opvejer den mulige risiko for dit ufødte barn.
English: If neutropenia develops during treatment it should be managed by dose delays.
Danish: Hvis der udvikles neutropeni under behandlingen, skal den behandles med dosis udsættelse.
English: Of these 33 patients who received the RP2D, 32 were evaluable for response.
Danish: Af de 33 patienter, som fik RP2D, kunne respons evalueres hos de 32.
English: The safety profile in elderly patients was consistent with that of adult patients.
Danish: Sikkerhedsprofilen hos ældre patienter svarede til den for voksne patienter.
English: Of the 329 patients, 165 patients were randomised to the treatment arm and 164 patients were randomised to the placebo arm.
Danish: Af de 329 patienter blev 165 patienter randomiseret til behandlingsarmen, og 164 patienter blev randomiseret til placeboarmen.
English: Median ADC AUC in children and adolescents from this study was approx. 14% and 3% lower than in adult patients, respectively, while MMAE exposures were 53% lower and 13% higher, respectively, than in adult patients.
Danish: Median ADC AUC hos børn og unge i dette studie var ca. henholdsvis 14 % og 3 % lavere end hos voksne patienter, mens MMAE-eksponering var henholdsvis 53 % lavere og 13 % højere end hos voksne patienter.
English: For further efficacy results, see Table 12 and Figure 5.
Danish: For yderligere virkningsresultater henvises til Tabel 12 og figur 5.
English: Grade 3 (interfering with activities of daily living)
Danish: Grad 3 (påvirker almindelige dagligdags aktiviteter)
English: Adverse reactions for ADCETRIS are listed by MedDRA System Organ Class and Preferred Term (see Table 3).
Danish: Bivirkninger for ADCETRIS er opstillet efter MedDRA Systemorganklasse og foretrukken term (se Tabel 3).
English: If you develop infusion reactions (as stated previously), your doctor may stop giving this medicine and start support treatment.
Danish: Hvis du får infusionsreaktioner (som angivet ovenfor), kan din læge måske stoppe med at give dig denne medicin og påbegynde en støttebehandling.
English: Physician's Choice (Methotrexate or Bexarotene) n = 64
Danish: Lægens valg (methotrexat eller bexaroten) n = 64
English: At least one metabolite of MMAE has been shown to be active in vitro.
Danish: Mindst en metabolit af MMAE har vist sig aktiv in vivo.
English: No differences were observed in quality of life between the treatment and placebo arms.
Danish: Der blev ikke observeret nogen forskel i livskvalitet mellem behandlings- og placeboarmen.
English: Acute pancreatitis has been observed in patients treated with ADCETRIS.
Danish: Akut pancreatitis er blevet observeret hos patienter i behandling med ADCETRIS.
English: The significance of this finding in stage IV HL patients with no extranodal disease is not established due to small patient numbers and low event rates (14 events).
Danish: Betydningen af dette resultat hos patienter med stadie IV HL uden ekstranodal sygdom er ikke vist pga. det lille antal patienter og den lave rate af tilfælde (14 tilfælde).
English: These results were consistent with the pharmacological effect of MMAE on the mitotic apparatus (disruption of the microtubule network) in cells.
Danish: Disse resultater var overensstemmende med den farmakologiske virkning af MMAE på det mitotiske apparat (nedbrydning af mikrotubulus-netværket) i celler.
English: • Relapsed or progressive HL that occurred <12 months from the end of frontline treatment
Danish: • Recidiverende eller progredierende HL, som forekom < 12 måneder efter afslutningen af primærbehandlingen
English: After the first dose of Adcetris in combination with chemotherapy, your doctor may also give you a medicine that will help prevent development or reduce the severity of neutropenia (decrease of white blood cell count) which can increase the risk of infection.
Danish: Efter den første dosis af Adcetris i kombination med kemoterapi vil din læge muligvis også give dig et lægemiddel, der vil hjælpe med at forhindre eller nedsætte sværhedsgraden af neutropeni (nedsat antal hvide blodlegemer), som kan øge risikoen for infektion.
English: Patients with Stage IV Disease
Danish: Patienter med stadie IV-sygdom
English: Immediate and delayed infusion-related reactions (IRR), as well as anaphylactic reactions, have been reported.
Danish: Umiddelbare og forsinkede infusionsrelaterede reaktioner (IRR) samt anafylaktiske reaktioner er blevet rapporteret.
English: Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out.
Danish: Selvom der ikke er etableret en kausal sammenhæng med ADCETRIS, kan risikoen for lungetoksicitet ikke udelukkes.
English: Fifty nine percent (59%) of patients had advanced stage disease (Stage III or IV) at initial diagnosis.
Danish: Ni og halvtreds procent (59 %) af patienterne havde fremskreden sygdomsstadie (stadie III eller IV) ved initial diagnose.
English: The following side effects have been reported with Adcetris alone:
Danish: Følgende bivirkninger er rapporteret med Adcetris alene:
English: ADCETRIS should not be used during pregnancy unless the benefit to the mother outweighs the potential risks to the foetus.
Danish: ADCETRIS bør ikke anvendes under graviditet, medmindre fordelen for moderen vejer tungere end den potentielle risiko for fosteret.
English: This expression is independent of disease stage, line of therapy or transplant status.
Danish: Denne præsentation er uafhængig af sygdommens fase, behandlingstypen eller transplantation status.
English: • Best response of PR or SD to most recent salvage therapy as determined by CT and/or PET scanning
Danish: • PR eller SD (stabil sygdom) som bedste respons på den seneste salvage-behandling fastlagt med CT- og/eller PET-scanning
English: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection with an absolute neutrophil count < 1.0 x 10
Danish: Febril neutropeni (feber af ukendt oprindelse uden klinisk eller mikrobiologisk dokumenteret infektion med et absolut neutrofiltal på <1,0 x 10
English: ADCETRIS-induced peripheral neuropathy is typically an effect of cumulative exposure to this medicinal product and is reversible in most cases.
Danish: ADCETRIS-induceret perifer neuropati er typisk et resultat af kumulativ eksponering for dette lægemiddel, og det er i de fleste tilfælde reversibelt.
English: No meaningful differences in quality of life (assessed by the EuroQol five dimensions questionnaire [EQ-5D] and Functional Assessment of Cancer Therapy-General [FACT-G]) were observed between the treatment arms.
Danish: Der blev ikke observeret betydende forskel i livskvalitet (vurderet med EQ-5D [EuroQol-spørgeskema med fem dimensioner] og FACT-G [Functional Assessment of Cancer Therapy-General]) mellem behandlingsarmene.
English: Number of deaths (%)
Danish: Antal dødsfald (%)
English: Stratified log-rank test was not performed for PFS per Investigator.
Danish: Stratificeret log-rank-test blev ikke udført for PFS iht.
English: 40.5 months
Danish: 40,5 måneder
English: Liver disease and other medical conditions that may have been present before you start taking Adcetris and some medications that you are currently taking might increase the risk of liver injury.
Danish: Leversygdom og andre medicinske tilstande, som kan have eksisteret, før du begyndte at få behandling med Adcetris, og visse lægemidler, du tager kan øge risikoen for leverskader.
English: 27.9 months
Danish: 27,9 måneder
English: The best overall response rate (ORR) per independent review facility (IRF) was analysed across both study phases at the RP2D.
Danish: Den bedste overordnede responsrate (ORR) ifølge Independent Review Facility (IRF) blev analyseret på tværs af begge studiefaser ved RP2D.
English: Fatigue, pyrexia, infusion-related reactions
Danish: Træthed, pyreksi, infusionsrelaterede reaktioner
English: Serious cases of hepatotoxicity, including fatal outcomes, have also occurred.
Danish: Alvorlige tilfælde af levertoksicitet, inkluderende dødelige udgange, er også forekommet.
English: At the time of analysis, the median modified PFS follow-up time for both arms was 24.6 months Data from an interim OS analysis
Danish: På tidspunktet for analyse var den mediane opfølgningstid for modificeret PFS for begge arme 24,6 måneder Data fra en foreløbig OS-analyse
English: Doxorubicin, vinblastine and dacarbazine (AVD)
Danish: Doxorubicin, vinblastin og dacarbazin (AVD)
English: The median number of cycles was approximately 12 cycles in the ADCETRIS arm.
Danish: Det mediane antal behandlingsserier var cirka 12 behandlingsserier i ADCETRIS-armen.
English: However, any patient who experiences an event of hyperglycaemia should have their serum glucose closely monitored.
Danish: Enhver patient, der oplever en hyperglykæmisk hændelse, skal have serum-glucose nøje monitoreret.
English: Within each System Organ Class, adverse reactions are listed under frequency categories of: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Inden for hver Systemeorganklasse er bivirkninger angivet under frekvenskategorierne: Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til < 1/100), Sjælden (≥ 1/10.000 til < 1/1.000); Meget sjælden (< 1/10.000); Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: Patients who develop Grade 3 or Grade 4 lymphopenia may continue treatment without interruption.
Danish: Patienter, der udvikler lymfopeni i Grad 3 eller Grad 4, kan fortsætte behandlingen uden afbrydelse.
English: The reconstituted solution should be inspected visually for any foreign particulate matter and/or discolouration.
Danish: Den rekonstituerede opløsning skal kontrolleres visuelt for eventuelle fremmed partikler og/eller misfarvning.
English: Liver function should be tested before initiating the treatment and routinely monitored in patients receiving ADCETRIS.
Danish: Leverfunktionen bør testes, før behandling igangsættes og monitoreres rutinemæssigt hos patienter, der behandles med ADCETRIS.
English: CTCL is a cancer of a certain type of white blood cell called a ‘T-cell' that mainly affects the skin.
Danish: CTCL er en form for kræft i en bestemt type hvide blodlegemer kaldet "T-celler", som hovedsagelig påvirker huden.
English: Symptoms of an anaphylactic reaction may include, but are not limited to, urticaria, angioedema, hypotension and bronchospasm.
Danish: Symptomer på en anafylaktisk reaktion kan omfatte, men er ikke begrænset til urticaria, angioødem, hypotension og bronkospasme.
English: MMAE did not induce any major CYP450 enzymes in primary cultures of human hepatocytes.
Danish: MMAE inducerede ikke nogen vigtigere CYP-enzymer i primære kulturer af humane hepatocytter.
English: ADCETRIS treatment should start following recovery from ASCT based on clinical judgment.
Danish: Behandling med ADCETRIS bør starte efter restitution fra ASCT på baggrund af klinisk vurdering.
English: MMAE is not likely to displace or to be displaced by highly protein-bound medicines.
Danish: Det er usandsynligt, at MMAE erstatter eller erstattes af stærkt protein-bundne lægemidler.
English: In vitro, MMAE was a substrate of P-gp and was not an inhibitor of P-gp at clinical concentrations.
Danish: In vitro var MMAE et substrat af P-gp og var ikke en P-gp-hæmmer ved kliniske koncentrationer.
English: Adcetris is used to treat CTCL where a specific type of protein is present on the cells' surface.
Danish: Adcetris bruges til at behandle CTCL, hvis der er en bestemt type protein til stede på cellernes overflade.
English: PML has been reported in patients who received this treatment after receiving multiple prior chemotherapy regimens.
Danish: Der er rapporteret PML hos patienter, der modtog behandling efter at have fået flere forudgående kemoterapiregimer.
English: 6.7 months
Danish: 6,7 måneder
English: Patients were stratified by these disease types and randomised 1:1 to receive either ADCETRIS or the physician's choice of either methotrexate or bexarotene.
Danish: Patienterne blev inddelt efter disse sygdomstyper og randomiseret 1:1 til at få enten ADCETRIS eller lægens valg af enten methotrexat eller bexaroten.
English: Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG United Kingdom
Danish: Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG Storbritannien
English: Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Austria
Danish: Takeda Austria GmbH St. Peter-Straβe 25 A-4020 Linz Østrig
English: The reconstituted solution in the vial is a clear to slightly opalescent, colourless solution with a final pH of 6.6.
Danish: Den rekonstituerede opløsning i hætteglasset er en klar til let uklar, farveløs opløsning med en endelig pH på 6,6.
English: The infusion may be restarted at a slower rate after symptom resolution.
Danish: Infusionen kan genstartes ved lavere hastighed efter, at symptomerne er ophørt.
English: Prior ASCT
Danish: Tidligere ASCT
English: The pharmacokinetics of ADCETRIS in combination with AVD were evaluated in a single phase 3 study in 661 patients.
Danish: Farmakokinetikken for ADCETRIS i kombination med AVD blev evalueret i et enkelt fase 3-studie med 661 patienter.
English: Classical Hodgkin lymphoma expresses specific proteins on the cell surface that are different from non-classical Hodgkin lymphoma.
Danish: Klassisk Hodgkins lymfom udtrykker specifikke proteiner på celleoverfladen, som adskiller sig fra ikke-klassisk Hodgkins lymfom.
English: This medicine contains 13.2 mg sodium (main component of cooking/table salt) in each vial.
Danish: Dette lægemiddel indeholder 13,2 mg natrium (hovedkomponent i madlavnings-/bordsalt) pr. hætteglas.
English: Based on population PK estimation the typical apparent central volume of distribution of MMAE was 35.5 l
Danish: Baseret på et populationfarmakokinetisk skøn var MMAE's typiske tilsyneladende centrale distributionsvolumen 35,5 l.
English: Within the cell, a single defined active species, MMAE, is released via proteolytic cleavage.
Danish: Inde i cellen frisættes en enkelt defineret aktiv art, MMAE via proteolytisk spaltning.
English: Patients should be carefully monitored during and after infusion.
Danish: Patienterne skal nøje monitoreres under og efter en infusion.
English: In case of overdose, the patient should be closely monitored for adverse reactions, particularly neutropenia, and supportive treatment should be administered (see section 4.4).
Danish: I tilfælde af overdosering bør patienten nøje monitoreres for bivirkninger, specielt neutropeni, og støttebehandling bør administreres (se pkt.
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives en anbefaling om dosering.
English: Your doctor may lower your starting dose to 1.2 mg/kg if you have kidney or liver problems.
Danish: Din læge kan nedsætte startdosis til 1,2 mg/kg, hvis du har nyre- eller leverproblemer.
English: If you think you have previously had a similar reaction, tell your doctor BEFORE you are given this medicine.
Danish: Hvis du mener, at du tidligere har haft en tilsvarende reaktion, skal du fortælle lægen om det, FØR du får medicinen.
English: Premedication may include paracetamol, an antihistamine and a corticosteroid.
Danish: Præmedicineringen kan omfatte paracetamol, antihistamin og corticosteroid.
English: Pharmacokinetics in special populations
Danish: Farmakokinetik hos specielle populationer
English: Less than half of the patients in the pivotal phase 2 population with Grade 3 or Grade 4 neutropenia had temporally associated infections, and the majority of temporally associated infections were Grade 1 or Grade 2.
Danish: Mindre end halvdelen af patienterne i den pivotale fase 2-population med Grad 3 eller Grad 4 neutropeni havde midlertidigt associerede infektioner, og størstedelen af de midlertidigt associerede infektioner var Grad 1 eller Grad 2.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler undtagen dem nævnt i pkt.
English: The following side effects have been reported with Adcetris in combination with chemotherapy medicines:
Danish: Følgende bivirkninger er rapporteret med Adcetris i kombination med kemoterapi-lægemidler:
English: The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).
Danish: Lægen skal være specielt opmærksom på symptomer, der tyder på PML, som patienten måske ikke selv opdager (fx kognitive, neurologiske eller psykiatriske symptomer).
English: More serious adverse events and dose modifications (including dose delays, reductions, and discontinuations) were reported in the older patients compared with the overall study population.
Danish: Der blev rapporteret flere alvorlige bivirkninger og dosismodifikationer (herunder udsat dosering, reduktioner og seponeringer) hos ældre patienter sammenlignet med den samlede studiepopulation.
English: John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in ADCETRIS-treated patients.
Danish: John Cunningham virus (JCV) reaktivering, som medfører progredierende multifokal leukoencefalopati (PML) og død, kan forekomme hos patienter behandlet med ADCETRIS.
English: Figure 5: Kaplan-Meier Plot of OS
Danish: Figur 5: Kaplan-Meier-plot af OS
English: Medical resource utilization (MRU) analysis showed that hospitalizations and outpatient visits, as well as working days/other activities missed by patients and caregivers were lower with ADCETRIS compared with placebo in patients with HL at increased risk of relapse.
Danish: Analyse af anvendte medicinske ressourcer (MRU) viste, at hospitalsindlæggelser og ambulante besøg samt arbejdsdage/andre aktiviteter, som patienter og omsorgspersoner ikke kunne deltage i, var lavere med ADCETRIS sammenlignet med placebo for patienter med HL med øget risiko for recidiv.
English: Treatment should be continued until disease progression or unacceptable toxicity(see section 4.4).
Danish: Behandlingen bør fortsættes indtil sygdomsprogression eller uacceptabel toksicitet (se pkt.
English: Adcetris is also used to lower the likelihood of classical Hodgkin Lymphoma coming back after an autologous stem cell transplant in patients with certain risk factors.
Danish: Adcetris bruges også for at mindske sandsynligheden for, at klassisk Hodgkins lymfom vender tilbage efter en autolog stamcelletransplantation hos patienter med visse risikofaktorer.
English: ADCETRIS should be administered through a dedicated intravenous line and it must not be mixed with other medicinal products (see section 6.2).
Danish: ADCETRIS skal administreres gennem et dedikeret intravenøst kateter og må ikke blandes med andre lægemidler (se pkt.
English: For a reduced dose, use 1.2 mg/kg for the calculation.
Danish: For en reduceret dosis benyttes 1,2 mg/kg til beregningen.
English: No patients required dose reduction or discontinued treatment for neutropenia.
Danish: Ingen patienter havde behov for dosisreduktion eller stoppede med behandlingen på grund af neutropeni.
English: Rash a, pruritus
Danish: Udslæt a, pruritus
English: In the event of either being observed, discard the medicinal product.
Danish: I tilfælde af at nogle af delene observeres, skal lægemidlet kasseres.
English: Two percent of patients required dose reduction and < 1% discontinued one of more of the study drugs due to neutropenia.
Danish: To procent af patienterne havde behov for dosisreduktion, og < 1 % stoppede med behandlingen med et eller flere af forsøgslægemidlerne som følge af neutropeni.
English: Fatigue, pyrexia
Danish: Træthed, pyreksi
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER BETINGEDE OMSTÆNDIGHEDER
English: The European Organization for Research and Treatment of Cancer Quality of Life 30-Item Questionnaire (EORTC-QLQ-C30) showed no clinically meaningful difference between the two arms in both the ITT and Stage IV population.
Danish: Spørgeskemaet EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life 30-Item) viste ingen klinisk betydningsfuld forskel mellem de to arme i både ITT- og stadie IV-populationerne.
English: The median observation time (time to death or last contact) from first dose was 71.4 months.
Danish: Den mediane observationsstid (tid indtil død eller sidste kontakt) fra første dosis var 71,4 måneder.
English: Arthralgia, myalgia
Danish: Artralgi, myalgi
English: Any portion left in the vial, after withdrawal of the volume to be diluted, must be disposed of in accordance with local requirements.
Danish: Tilbageværende rester i hætteglasset, efter optrækket af volumet til fortyndingen, skal bortskaffes i henhold til lokale retningslinjer.
English: Patients should be closely monitored for new or worsening abdominal pain, which may be suggestive of acute pancreatitis.
Danish: Patienterne bør overvåges nøje for nye eller forværrede abdominalsmerter, hvilket kan være tegn på akut pancreatitis.
English: Herpes zoster, Pneumocystis jiroveci pneumonia
Danish: Herpes zoster, pneumocystis jiroveci pneumoni
English: Grade 4 (sensory neuropathy which is disabling or motor neuropathy that is life threatening or leads to paralysis)
Danish: Grad 4 (sensorisk neuropati som er invaliderende eller motorisk neuropati som er livstruende eller medfører paralyse)
English: 3.6 vials a.
Danish: 3,6 hætteglas a.
English: Data in HL Patients Who Are Not Stem Cell Transplant (SCT) Candidates
Danish: Data for patienter med HL, som ikke er kandidater til stamcelletransplantation (ASCT).
English: Table 5 provides the efficacy results for modified PFS and overall survival (OS) in the ITT population and patients with Stage IV disease.
Danish: Tabel 5 viser effektresultaterne for modificeret PFS og samlet overlevelse (OS) i ITT-populationen og patienter med stadie IV-sygdom.
English: Investigations Very common:
Danish: Undersøgelser Meget almindelig
English: Prior chemotherapy Regimens Time from ASCT to first post-transplant relapse
Danish: Tidligere kemoterapi-regimer Tid fra ASCT til første recidiv efter transplantation
English: The pharmacokinetics of brentuximab vedotin were evaluated in phase 1 studies and in a population pharmacokinetic analysis of data from 314 patients.
Danish: Farmakokinetikken for brentuximab vedotin blev evalueret i fase 1-studier og i en populationsfarmakokinetisk analyse af data fra 314 patienter.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger - Gem indlægssedlen.