FrancophonIA/ELRC3.0 huggingface dataset:
English: The already reconstituted ADCETRIS can also be diluted into 5% dextrose for injection or Lactated Ringer's for injection.
Danish: Det allerede rekonstituerede ADCETRIS kan også fortyndes i 5 % dextrose til injektion eller Ringerlaktat til injektion.
English: The already reconstituted Adcetris can also be diluted into 5% dextrose for injection or Lactated Ringer's for injection.
Danish: Det allerede rekonstituerede Adcetris kan også fortyndes i 5% dextrose til injektion eller Ringerlaktat til injektion.
English: A pre-specified subgroup analysis of mPFS by disease stage showed that patients with Stage IV disease had a larger effect compared with the ITT population, with an unstratified hazard ratio of 0.71 (95% CI, 0.53; 0.96), compatible with a 29% reduction in the risk of modified PFS events for ADCETRIS+ AVD versus ABVD.
Danish: En præspecificeret subgruppeanalyse af mPFS efter sygdomsstadie viste, at patienter med stadie IV-sygdom oplevede en større effekt sammenlignet med ITT-populationen, med en ikke-stratificeret hazard ratio på 0,71 (95 % CI, 0,53; 0,96), sammenlignelig med en 29 % reduktion i risikoen for modificerede PFS-hændelser for ADCETRIS + AVD kontra ABVD.
English: In the study of ADCETRIS as combination therapy with AVD in 662 patients with previously untreated advanced HL (C25003), the most common adverse reactions (≥ 10%) were: neutropenia, nausea, constipation, vomiting, fatigue, peripheral sensory neuropathy, diarrhoea, pyrexia, alopecia, peripheral motor neuropathy, decreased weight, abdominal pain, anaemia, stomatitis, febrile neutropenia, bone pain, insomnia, decreased appetite, cough, headache, arthralgia, back pain, dyspnoea, myalgia, upper respiratory tract infection, alanine aminotransferase increased.
Danish: I studiet af ADCETRIS som kombinationsbehandling med AVD hos 662 patienter med ikke tidligere behandlet fremskreden HL (C25003) var de mest almindelige bivirkninger (≥ 10 %): neutropeni, kvalme, obstipation, opkastning, træthed, perifer sensorisk neuropati, diarré, pyreksi, alopeci, perifer motorisk neuropati, vægttab, abdominalsmerter, anæmi, stomatit, febril neutropeni, knoglesmerter, insomni, appetitmangel, hoste, hovedpine, artralgi, rygsmerter, dyspnø, myalgi, infektion i de øvre luftveje og forhøjet alaninaminotransferase.
English: Objective response rate (CR + PR) Complete remission (CR) Partial remission (PR)
Danish: Objektiv responsrate (CR + PR) Komplet remission (CR) Partiel remission (PR)
English: Brentuximab vedotin caused embryo-foetal lethality in pregnant female rats.
Danish: Brentuximab vedotin medførte embryo-føtal letalitet hos drægtige hunrotter.
English: 378M (57) 286F (43)
Danish: 378 M (57) 286 K (43)
English: The range of DOR was 1.2+ months to 43+ months and the median follow-up time from first dose for patients who achieved objective response (OR) per IRF was 9.0 months.
Danish: Området for DOR var 1,2+ måneder til 43+ måneder, og den mediane opfølgningstid fra første dosis for patienter, der opnåede objektiv respons (OR) iht.
English: Study SGN35-005
Danish: Studie SGN35-005
English: Haematological toxicities
Danish: Hæmatologiske toksiciteter
English: Peripheral sensory neuropathy, peripheral motor neuropathy
Danish: Perifer sensorisk neuropati, perifer motorisk neuropati
English: 58.5 years (22-83)
Danish: 58,5 år (22-83)
English: Complete blood counts should be monitored prior to administration of each dose of this treatment (see section 4.4).
Danish: Fuldblodstal skal monitoreres før administration af hver enkelt dosis af denne behandling (se pkt.
English: Refer to the summary of product characteristics (SmPC) of chemotherapy agents given in combination with ADCETRIS for patients with previously untreated HL.
Danish: Se produktresuméet for de kemoterapeutika, der gives i kombination med ADCETRIS, ved behandling af patienter med ikke tidligere behandlet HL.
English: Skin and subcutaneous tissue disorders Very common:
Danish: Hud og subkutane væv Meget almindelig:
English: A multiexponential decline in ADC serum concentrations was observed with a terminal half-life of approximately 4 to 6 days.
Danish: Et multieksponentielt fald i ADC-serumkoncentrationer blev observeret ved en terminal halveringstid på cirka 4 til 6 dage.
English: The efficacy and safety of ADCETRIS as a single agent was evaluated in a pivotal phase 3, openlabel, randomised, multicentre study in 128 patients with histologically confirmed CD30+ CTCL.
Danish: ADCETRIS' virkning og sikkerhed som enkeltstof blev evalueret i et åbent, randomiseret, pivotalt fase 3-multicenterstudie med 128 patienter med histologisk bekræftet CD30+ CTCL.
English: To perform a single-arm study in a similar patient population as the sALCL population investigating response rate, duration of response, rate of (second) ASCT and data in subpopulations (including but not necessarily restricted to ALK status and age) based on a CHMP agreed protocol (Study C25006).
Danish: Der skal gennemføres et enkelt-armet studie med en population tilsvarende sALCL-populationen, som skal kortlægge responsraten, varigheden af respons, tiden ind til anden ASCT samt data for underliggende populationer (inkluderende men ikke nødvendigvis forbeholdt ALK status og alder).
English: The primary endpoint was objective response rate that lasts at least 4 months (ORR4) (duration from first response to last response ≥ 4 months), as determined by an independent review of the Global Response Score (GRS) consisting of skin evaluations (modified severity weighted assessment tool [mSWAT] as assessed per investigator), nodal and visceral radiographic assessment, and detection of circulating Sézary cells (Olsen 2011).
Danish: ORR4 blev fastlagt gennem en uafhængig vurdering af Global Response Score (GRS)bestående af hudevalueringer (mSWAT, modified severity weighted assessment tool, som vurderet af investigator), nodal og visceral radiologisk vurdering samt påvisning af cirkulerende Sézary-celler (Olsen 2011).
English: Extracutaneous disease
Danish: Ekstrakutan sygdom
English: How Adcetris is given
Danish: Sådan gives Adcetris
English: The median number of cycles was 7 (range 1 to 16 cycles).
Danish: Det mediane antal serier var 7 (interval 1 til 16 serier).
English: In clinical trials treatment emergent neuropathy occurred in 59% of the population, peripheral motor neuropathy occurred in 14% of patients.
Danish: I kliniske forsøg forekom behandlingsrelateret neuropati hos 59 % af populationen, og perifer motorisk neuropati forekom hos 14 % af patienterne.
English: In the Stage IV population, 35% fewer patients treated with ADCETRIS + AVD received subsequent salvage chemotherapy (n = 45) compared with those treated with ABVD (n = 69) and 22% fewer patients treated with ADCETRIS + AVD received high-dose chemotherapy and transplant (n = 29) compared with those treated with ABVD (n = 37).
Danish: I stadie IV-populationen fik 35 % færre patienter, der fik behandling med ADCETRIS + AVD, efterfølgende salvage-kemoterapi (n = 45) sammenlignet med de patienter, der fik behandling med ABVD (n = 69), og 22 % færre patienter, der fik behandling med ADCETRIS + AVD, fik højdosiskemoterapi og transplantation (n = 29) sammenlignet med de patienter, der fik behandling med ABVD (n = 37).
English: ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) (see section 5.1).
Danish: ADCETRIS er indiceret til behandling af voksne patienter med CD30+ HL med øget risiko for recidiv eller progression efter autolog stamcelletransplantation (ASCT) (se pkt.
English: For the patients who received > 1 prior cancer-related treatment, a best overall response of CR was reported for 6 patients (12%); PR was reported for 19 patients (39%).
Danish: For de patienter, som tidligere havde fået > 1 cancerrelateret behandling, blev CR som bedste samlede respons rapporteret for 6 patienter (12 %), og PR blev rapporteret for 19 patienter (39 %).
English: Citric acid monohydrate (for pH-adjustment) Sodium citrate dihydrate (for pH-adjustment) α,α-Trehalose dihydrate Polysorbate 80
Danish: Citronsyremonohydrat (til justering af pH) Natriumcitrat-dihydrat (til justering af pH) α,α-trehalosedihydrat Polysorbat 80
English: The pharmacokinetics of brentuximab vedotin ADC and MMAE following a 30-minute intravenous infusion of BV administered at 1.4 mg/kg or 1.8 mg/kg given every 3 weeks were evaluated in a phase 1/2 clinical trial of 36 paediatric patients (7-17 years of age) with r/r HL and sALCL (children aged 7-11 years, n = 12 and adolescents aged 12 to 17 years, n = 24) (see section 5.1).
Danish: Farmakokinetikken for brentuximab vedotin ADC og MMAE efter en intravenøs infusion af brentuximab vedotin over 30 minutter administreret som 1,4 mg/kg eller 1,8 mg/kg hver 3. uge blev evalueret i et fase 1/2 klinisk forsøg med 36 pædiatriske patienter (i alderen 7-17 år) med r/r HL og sALCL (børn i alderen 7-11 år: n = 12 og unge i alderen 12-17 år: n = 24) (se pkt.
English: MMAE were observed approximately 2 days after the end of infusion, and exhibited a mono-exponential decline with a t1/2z of approximately 3 to 4 days.
Danish: Maksimale plasmakoncentrationer for MMAE blev observeret cirka 2 dage efter afslutning af infusionen og udviste et monoeksponentielt fald med en t1/2z på cirka 3 til 4 dage.
English: The analyses showed a consistent trend towards benefit for patients who received ADCETRIS + AVD compared with patients who received ABVD in most subgroups.
Danish: Analyserne viste konsekvent en tendens til fordel for de patienter, som fik ADCETRIS + AVD sammenlignet med patienter, som fik ABVD, i de fleste subgrupper.
English: ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy (see section 5.1).
Danish: ADCETRIS er indiceret til behandling af voksne patienter med CD30+ kutant T-cellelymfom (CTCL) efter mindst 1 forudgående systemisk behandling (se pkt.
English: 62 years (22-83)
Danish: 62 år (22-83)
English: The safety, pharmacokinetics and anti-tumour activity of ADCETRIS in 36 paediatric patients (7-17 years of age) with r/r HL and sALCL (children aged 7-11 years, n = 12 and adolescents aged 12 to 17 years, n = 24) were evaluated in a phase 1/2 open-label, single-agent, multicentre doseescalation study (C25002).
Danish: Sikkerheden, farmakokinetikken samt antitumoraktiviteten ved ADCETRIS er evalueret hos 36 pædiatriske patienter (i alderen 7-17 år) med r/r HL og sALCL (fordelt på børn i alderen 7-11 år: n=12 og unge i alderen 12-17 år: n=24) i et åbent fase 1/2 enkeltstof dosiseskalerings multicenterstudie (C25002).
English: Unopened vial: Store in a refrigerator (2 °C-8 °C).
Danish: Uåbnede hætteglas: Opbevares i køleskab (2 °C-8 °C).
English: 0C; ref CTCAE v3) has been reported with treatment with ADCETRIS.
Danish: 9/l, feber ≥ 38,5°C; ref. CTCAE v3) er rapporteret ved behandling med ADCETRIS.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om Adcetris på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/ og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
English: Table 15: Sample calculations for patients receiving the recommended dose of 1.8 mg/kg of ADCETRIS for weights ranging from 60 kg to 120 kg
Danish: Tabel 15: Beregninger for patienter, der får den anbefalede dosis på 1,8 mg/kg ADCETRIS for et vægtinterval mellem 60 kg og 120 kg
English: Withhold treatment with ADCETRIS until toxicity is ≤ Grade 2, then restart treatment at a reduced dose to 0.9 mg/kg every 2 weeks.
Danish: Tilbagehold behandling med ADCETRIS, indtil toksicitet er ≤ Grad 2, og genoptag derefter behandlingen med en reduceret dosis på 0,9 mg/kg hver 2. uge.
English: IRRs are more frequent and more severe in patients with antibodies to brentuximab vedotin (see section 4.8).
Danish: IRR ses hyppigere og er sværere hos patienter med antistoffer mod brentuximab vedotin (se pkt.
English: Total dose = patient weight multiplied by recommended dose [1.2 mg/kg a])
Danish: Total dosis = patientvægt multipliceret med den anbefalede dosis [1,2 mg/kg
English: Typical Cmax and AUC of ADC after a single 1.8 mg/kg in a phase 1 study was approximately 31.98 μg/ mL and 79.41 μg/ mL x day respectively.
Danish: Typisk Cmax og AUC for ADC efter en enkelt 1,8 mg/kg dosis i et fase 1-studie var henholdsvis cirka 31,98 μg/ml og 79,41 μg/ml x dag.
English: The safety data in patients with relapsed or refractory HL who had not received an autologous stem cell transplant and were treated with the recommended dose of 1.8 mg/kg every three weeks in a single-arm phase 4 study (n = 60), the phase 1 dose escalation and clinical pharmacology studies (n = 15 patients) and in the NPP (n = 26 patients) (see section 5.1) were consistent with the safety profile of the pivotal clinical studies.
Danish: Sikkerhedsdata fra patienter med recidiverende eller refraktær HL, som ikke havde fået en autolog stamcelletransplantation, og som blev behandlet med den anbefalede dosis på 1,8 mg/kg hver tredje uge i enten et enkelt-armet fase 4-studie (n = 60), i fase 1 dosisoptrapnings- og klinisk farmakologiske studier (n = 15 patienter) eller i et NPP (n = 26 patienter) (se pkt.
English: The range of DOR was 0.1 months to 39.1+ months and the median follow-up time from first dose for patients who achieved objective response (OR) per IRF was 15.5 months.
Danish: Området for DOR var 0,1 måneder til 39,1+ måneder, og den mediane opfølgningstid fra første dosis for patienter, der opnåede objektiv respons (OR) iht.
English: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS.
Danish: Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN) er rapporteret for ADCETRIS, herunder dødelige tilfælde.
English: Note: If patient's weight is more than 100 kg, the dose calculation should use 100 kg.
Danish: Bemærk: Hvis patienten vejer mere end 100 kg, skal dosiskalkulationen gå ud fra 100 kg.
English: Median age (range)
Danish: Median alder (interval)
English: Stevens-Johnson syndrome/toxic epidermal necrolysis
Danish: Stevens-Johnsons syndrom/toksisk epidermal nekrolyse
English: Nausea, diarrhoea vomiting, constipation, abdominal pain
Danish: Kvalme, diarré, opkastning, obstipation, abdominalsmerter
English: The median number of cycles was 7 (range, 2 to 37 cycles).
Danish: Det mediane antal serier var 7 (interval 2 til 37 serier).
English: Medicines of this type (monoclonal antibodies) can cause infusion reactions such as: a rash shortness of breath difficulty breathing cough a tight chest fever back pain chills headache feeling sick (nausea) or being sick (vomiting).
Danish: Medicin af denne type (monoklonale antistoffer) kan give infusionsreaktioner, så som: - Udslæt - Kortåndethed - Åndedrætsbesvær - Hoste - Strammen over brystet - Feber - Rygsmerter - Kulderystelser - Hovedpine - Kvalme eller opkastning.
English: Instructions for reconstitution
Danish: Vejledning i rekonstitution
English: b. To be diluted in 150 mL of diluent and administered by intravenous infusion over 30 minutes every 3 weeks.
Danish: Skal fortyndes i 150 ml diluent og administreres ved intravenøs infusion over 30 minutter hver 3. uge.
English: Pre-specified subgroup analyses of ORR4 per IRF were performed by patients' CTCL subtype, physicians' choice of treatment, baseline ECOG status, age, gender, and geographic region.
Danish: IRF efter patienternes CTCL-undertype, lægens valg af behandling, ECOG-status ved baseline, alder, køn og geografisk område.
English: - shortness of breath or cough (may affect more than 1 in 10 people) - flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin (may affects up to 1 in 100 people) - a change in feeling or sensitivity, especially in the skin, numbness, tingling, discomfort, a burning sensation, weakness, or pain in the hands or feet (neuropathy; may affect more than 1 in 10 people) - a feeling of weakness (may affect more than 1 in 10 people) - constipation (may affect more than 1 in 10 people) - diarrhoea, vomiting (may affect more than 1 in 10 people) - chills or shivering (may affect up to 1 in 10 people) - feeling tired, frequent urination, increased thirst, increased appetite with unintended weight loss, and irritability (these may be signs of hyperglycaemia, which may affect up to1 in 10 people) - unusual bleeding or bruising under the skin, longer than usual bleeding after your blood has been drawn, or bleeding from your gums (these may be signs of thrombocytopenia which may affect up to 1 in 10 people) - headaches, experience dizziness, look pale (these may be signs of anaemia, which may affect more than 1 in 10 people)
Danish: - åndenød eller hoste (kan forekomme hos mere end 1 ud af 10 personer) - influenza-lignende symptomer efterfulgt af et smertefuldt rødt eller lilla udslæt, der breder sig og danner blærer herunder omfattende afskalning af huden (kan forekomme hos op til 1 ud af 100 personer) - En forandring i følelse eller følsomhed, specielt i huden, følelsesløshed, snurren, ubehag, en brændende fornemmelse, svaghed eller smerte i hænder eller fødder (neuropati; kan forekomme hos flere end 1 ud af 10 personer) - En følelse af svaghed (kan forekomme hos flere end 1 ud af 10 personer) - Forstoppelse (kan forekomme hos flere end 1 ud af 10 personer) - Diarré, opkastning (kan forekomme hos flere end 1 ud af 10 personer) - Kuldegysninger eller kulderystelser (kan forekomme hos op til 1 ud af 10 personer) - Træthedsfølelse, hyppig vandladning, øget tørst, øget appetit med utilsigtet vægttab og irritabilitet (dette kan være tegn på hyperglykæmi, som kan forekomme hos op til 1 ud af 10 personer) - Usædvanlig blødning eller blå mærker under huden, længere blødning end normalt efter blodprøvetagning, eller blødning fra tandkødet (dette kan være tegn på trombocytopeni, som kan forekomme hos op til 1 ud af 10 personer) - hovedpine, oplever svimmelhed, ser bleg ud (dette kan være tegn på anæmi, der kan forekomme hos flere end 1 ud af 10 personer)
English: 398M (59) 272F (41)
Danish: 398 M (59) 272 K (41)
English: • HL that occurred <12 months or HL that was refractory to frontline therapy
Danish: • HL, som forekom < 12 måneder efter primær behandling, eller HL, som var refraktær overfor primær behandling
English: In the clinical trial of ADCETRIS as combination therapy, treatment emergent neuropathy occurred in 67% of the population; peripheral motor neuropathy occurred in 11% of patients.
Danish: I det kliniske forsøg med ADCETRIS som kombinationsbehandling forekom behandlingsrelateret neuropati hos 67 % af populationen; perifer motorisk neuropati forekom hos 11 % af patienterne.
English: Stevens-Johnson syndrome and toxic epidermal necrolysis
Danish: Stevens-Johnsons syndrom og toksisk epidermal nekrolyse
English: Total dose = patient weight multiplied by recommended dose [1.8 mg/kg a])
Danish: Total dosis = patientvægt multipliceret med den anbefalede dosis [1,8 mg/kg
English: Objective response rate (CR + PR)
Danish: Objektiv responsrate (CR + PR)
English: Median number of prior chemotherapy regimens (range)
Danish: Sygdomskarakteristika Mediant antal tidligere kemoterapiregimer (interval)
English: Stratified Hazard Ratio
Danish: Stratificeret Hazard Ratio
English: The efficacy in elderly patients with Stage IV disease in the A + AVD arm (patients ≥ 60 years of age [n = 118] [HR = 0.80, 95% CI (0.42, 1.53)] and ≥ 65 years of age [n = 78] [HR = 0.78, 95% CI (0.36, 1.67)]) showed better benefit compared with elderly patients in ITT population.
Danish: Virkningen hos ældre patienter med stadie IV-sygdom i A + AVD-armen (patienter ≥ 60 år [n = 118] [HR = 0,80; 95 % CI (0,42; 1,53)] og ≥ 65 år [n = 78] [HR = 0,78; 95 % CI (0,36; 1,67)]) viste større gavn sammenlignet med ældre patienter i ITT-populationen.
English: - The other ingredients are citric acid monohydrate, sodium citrate dihydrate, α,α-trehalose dihydrate, and polysorbate 80.
Danish: Øvrige indholdsstoffer: Citronsyremonohydrat, natriumcitratdihydrat, α,α-trehalose-dihydrat og polysorbat 80.
English: Psychiatric Disorders Very common:
Danish: Psykiske forstyrrelser Meget almindelig:
English: Each single use vial must be reconstituted with 10.5 mL of water for injections to a final concentration of 5 mg/ mL.
Danish: Hvert engangs-hætteglas skal rekonstitueres med 10,5 ml vand til injektioner til en endelig koncentration på 5 mg/ml.
English: Uncommon side effects (may affect up to 1 in 100 people) - Tumour lysis syndrome - a potentially-life threatening condition in which you may experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances.
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) - Tumorlysesyndrom - en potentielt livstruende tilstand, hvor du kan opleve svimmelhed, nedsat vandladning, forvirring, opkastning, kvalme, hævelse, stakåndethed eller forstyrrelser af hjerterytmen.
English: Twenty-eight patients (47%) went on to receive SCT after a median of 7 cycles (range, 4 to 16 cycles) of ADCETRIS treatment.
Danish: Otteogtyve patienter (47 %) fik efterfølgende ASCT efter et mediant antal serier på 7 (interval 4 til 16 serier) med behandling med ADCETRIS.
English: Keep the vial in the outer carton in order to protect from light.
Danish: Opbevares i den originale yderpakning for at beskytte mod lys.
English: Adverse reactions (combination therapy)
Danish: Bivirkninger (monoterapi) Bivirkninger (kombinationsbehandling)
English: Each vial contains a 10% overfill giving 55 mg of Adcetris per vial and a total reconstituted volume of 11 mL.
Danish: Hvert hætteglas indeholder et overskud på 10 %, hvilket giver 55 mg Adcetris per hætteglas og et samlet rekonstitueret mængde på 11 ml.
English: Modification of dosing schedule
Danish: Modificering af dosisplan Modificering af dosisplan
English: Bone marrow involvement at time of diagnosis or study entry, n (%)
Danish: Knoglemarvsinvolvering på tidspunktet for diagnosticering eller indgang i studiet, n (%) B-symptomer a, n (%)
English: The primary endpoint in Study C25003 was modified PFS (mPFS) per independent review facility (IRF), defined as time from randomisation to disease progression, death, or evidence of non-complete response (non-CR) after completion of first-line therapy per IRF followed by subsequent anticancer therapy.
Danish: Independent Review Facility (IRF), defineret som tid fra randomisering til sygdomsprogression eller død, eller evidens for ikke-komplet respons (non-CR) efter fuldførelse af førstelinjebehandling iht.
English: 3.6 vials
Danish: 3,6 hætteglas
English: Nervous system disorders Very common:
Danish: Nervesystemet Meget almindelig:
English: Following dilution, infuse the ADCETRIS solution immediately at the recommended infusion rate.
Danish: Efter fortynding infunderes Adcetris-opløsningen umiddelbart ved den anbefalede infusionshastighed.
English: 33 years (18-71)
Danish: 33 år (18-71)
English: Infections and infestations Very common:
Danish: Infektioner og parasitære sygdomme Meget almindelig:
English: Cutaneous T-cell lymphoma
Danish: Kutant T-cellelymfom
English: Adcetris 50 mg powder for concentrate for solution for infusion brentuximab vedotin
Danish: Adcetris 50 mg pulver til koncentrat til infusionsvæske, opløsning brentuximab vedotin
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om ADCETRIS findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk.
English: Baseline patient characteristics showed failure from multiple prior chemotherapy regimens (median of 3 with a range of 1 to 7) before first administration with ADCETRIS.
Danish: Patientkarakteristika før den første administration af ADCETRIS viste behandlingssvigt på flere tidligere kemoterapi regimer (median på 3 med et interval på 1 til 7).