FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were treated on days 1 and 15 of each 28-day cycle with 1.2 mg/kg of ADCETRIS administered as an intravenous infusion over 30 minutes + doxorubicin 25 mg/m vinblastine 6 mg/m2, and dacarbazine 375 mg/m2.
Danish: Patienterne blev behandlet på dag 1 og 15 i hver 28-dages behandlingsserie med 1,2 mg/kg ADCETRIS administreret som en intravenøs infusion over 30 minutter + doxorubicin 25 mg/m2, vinblastin 6 mg/m2 og dacarbazin 375 mg/m2.
English: Out of the 49 patients receiving > 1 line of prior treatment, 22 patients (45%) received subsequent SCT; of the 11 patients who had received 1 prior treatment, 6 patients (55%) received subsequent SCT.
Danish: Af de 49 patienter, som tidligere havde modtaget > 1 behandlingslinje, fik 22 patienter (45 %) efterfølgende ASCT, og af de 11 patienter, som tidligere havde modtaget 1 behandling, fik 6 patienter (55 %) efterfølgende ASCT.
English: Among these 30 patients, the median time to response, defined as the time from first dose to the soonest of PR or CR, was 6 weeks (range, 5 to 39 weeks).
Danish: Blandt disse 30 patienter var den mediane tid til respons, defineret som tiden fra første dosis til den tidligste respons i form af PR eller CR 6 uger (interval 5 til 39 uger).
English: The efficacy and safety of ADCETRIS were evaluated in a randomised, open-label, 2-arm, multicenter trial in 1334 patients with previously untreated advanced HL in combination with chemotherapy (doxorubicin [A], vinblastine [V] and dacarbazine [D] [AVD]).
Danish: Virkningen og sikkerheden af ADCETRIS blev evalueret i et randomiseret, open-label, 2-armet multicenterforsøg med 1.334 patienter med ikke tidligere behandlet fremskreden HL i kombination med kemoterapi (doxorubicin [A], vinblastin [V] og dacarbazin [D] [AVD]).
English: MMAE has been shown to have aneugenic properties in an in vivo rat bone marrow micronucleus study.
Danish: MMAE har vist sig at have aneugene egenskaber i et in vivo-mikronukleus-studie på knoglemarv.
English: Number of vials needed = total volume to be diluted divided by total volume per vial [10 mL/vial])
Danish: Antal nødvendige hætteglas = totalt volumen der skal fortyndes divideret med totalt volumen per hætteglas [10 ml/hætteglas]
English: A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from this therapy, taking into account a potential risk of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med brentuximab vedotin skal ophøre, idet der tages højde for den potentielle risiko ved amning af barnet i forhold til de terapeutiske fordele for kvinden.
English: At the time of last evaluation, most of the patients (82-85%) who experienced peripheral neuropathy had resolution or improvement of their peripheral neuropathy symptoms.
Danish: På tidspunktet for den sidste evaluering havde de fleste af patienterne (82-85 %), der oplevede perifer neuropati, ophør eller bedring af deres symptomer på perifer neuropati.
English: Table 1: Dosing recommendations for neutropenia
Danish: Tabel 1: Dosisanbefalinger ved neutropeni
English: p-value=0.199
Danish: p-værdi = 0,199
English: Table 5: Efficacy results for previously untreated HL patients treated with 1.2 mg/kg of ADCETRIS + AVD on days 1 and 15 of a 28-day cycle (ITT and Stage IV)
Danish: Tabel 5: Effektresultater for ikke tidligere behandlede HL-patienter behandlet med 1,2 mg/kg ADCETRIS + AVD på dag 1 og 15 i en 28-dages behandlingsserie (ITT og stadie IV)
English: Other medicines and Adcetris
Danish: Brug af anden medicin sammen med Adcetris
English: = Number of ADCETRIS vials needed
Danish: =antal nødvendige hætteglas med ADCETRIS
English: Primary prophylaxis with growth factor support (G-CSF) is recommended for all patients with previously untreated HL receiving combination therapy beginning with the first dose (see section 4.4).
Danish: Primær profylakse med vækstfaktorstøtte (G-CSF) anbefales til alle patienter med ikke tidligere behandlet HL, som får kombinationsbehandling, startende med den første dosis (se pkt.
English: Patients with CTCL should receive up to 16 cycles (see section 5.1).
Danish: Patienter med CTCL bør have op til 16 behandlingsserier (se pkt.
English: The most common prior skin directed therapies in the ITT population were radiotherapy (64%), phototherapy (48%) and topical steroids (17%).
Danish: De mest almindelige forudgående hudrettede behandlinger i ITT-populationen var strålebehandling (64 %), lysbehandling (48 %) og topikale steroider (17 %).
English: Use of ADCETRIS in combination with chemotherapy should be avoided in patients with moderate and severe hepatic impairment.
Danish: Brugen af ADCETRIS i kombination med kemoterapi bør undgås hos patienter med moderat og svært nedsat leverfunktion.
English: Among patients who experienced peripheral neuropathy in the pivotal phase 2 studies (SG035-0003 and SG035-0004) and randomised phase 3 monotherapy studies (SGN35-005 and C25001), the median follow up time from end of treatment until last evaluation ranged from 48.9 to 98 weeks.
Danish: Blandt de patienter i de pivotale fase 2-studier (SG035-0003 og SG035-0004) samt randomiserede fase 3-studier med monoterapi (SGN35-005 og C25001), der oplevede perifer neuropati, lå den mediane opfølgningstid fra afslutning af behandlingen til sidste evaluering i intervallet 48,9 til 98 uger.
English: The doctor or nurse will dispose of this medicine.
Danish: Lægen eller sundhedspersonalet vil bortskaffe medicinenrester.
English: Therefore, co-administration of ADCETRIS with bleomycin is contraindicated (see section 4.2).
Danish: Derfor er samtidig administration af ADCETRIS og bleomycin kontraindiceret (se pkt.
English: For the patients who received 1 prior cancer-related treatment, CR was reported for 1 patient (9%) and PR was reported for 4 patients (36%).
Danish: For de patienter, som tidligere havde fået 1 cancerrelateret behandling, blev CR rapporteret for 1 patient (9 %), og PR blev rapporteret for 4 patienter (36 %).
English: Brentuximab vedotin is an antibody drug conjugate (ADC) that delivers an antineoplastic agent that results in apoptotic cell death selectively in CD30-expressing tumour cells.
Danish: Brentuximab vedotin er et antistof-lægemiddel-konjugat (ADC), som frigiver et antineoplastisk middel, der medfører apoptotisk celledød selektivt i tumorceller, der udtrykker CD30.
English: These patients should receive up to 16 cycles (see section 5.1).
Danish: Disse patienter bør have op til 16 behandlingsserier (se pkt.
English: Use of ADCETRIS in combination with chemotherapy should be avoided in patients with severe renal impairment.
Danish: Brugen af ADCETRIS i kombination med kemoterapi bør undgås hos patienter med svært nedsat nyrefunktion.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AFIKKE ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: Combination therapy Note: Primary prophylaxis with G-CSF is recommended for all patients receiving combination therapy beginning with the first dose.
Danish: Kombinationsbehandling Bemærk: Primær profylakse med G-CSF anbefales til alle patienter, der får kombinationsbehandling, startende med den første dosis
English: See Table 1 below for appropriate dosing recommendations (see also section 4.4).
Danish: Se nedenstående Tabel 1 for passende doseringsanbefalinger (se også pkt.
English: Adverse events led to treatment discontinuation in 13% of patients.
Danish: Bivirkninger førte til seponering af behandlingen hos 13 % af patienterne.
English: The analyses showed a consistent trend towards benefit for patients who received ADCETRIS compared with patients who received physician's choice.
Danish: Analyserne viste en ensartet tendens mod en fordel for patienter, der fik ADCETRIS, sammenlignet med patienter, der fik lægens valg.
English: Nausea, constipation, vomiting, diarrhoea, abdominal pain, stomatitis
Danish: Kvalme, obstipation, opkastning, diarré, abdominalsmerter, stomatit
English: - Stevens-Johnson syndrome - a rare, serious disorder in which you may experience flu-like symptoms followed by a painful red or purplish rash that spreads and blisters including extensive detachment of the skin - new or recurring cytomegalovirus (CMV) infection
Danish: - Stevens-Johnsons syndrom - en sjælden, alvorlig sygdom, hvor du kan opleve influenzalignende symptomer efterfulgt af et smertefuldt rødt eller lilla udslæt, der spreder sig og danner blærer, herunder omfattende afskalning af huden - nye eller tilbagevendende cytomegalovirusinfektioner (CMV)
English: ADCETRIS dose (mg/kg) x patient's body weight (kg)
Danish: ADCETRIS-dosis (mg/kg) x patientens vægt (kg) = Total ADCETRIS-dosis (mL) der skal yderligere fortyndes
English: After multiple-dose, IV infusion of 1.2 mg/kg brentuximab vedotin every two weeks, maximal serum concentrations of ADC were observed near the end of the infusion and elimination exhibited a multi-exponential decline with a t1/2z of approximately 4 to 5 days.
Danish: Efter flere doser ved intravenøs infusion af 1,2 mg/kg brentuximab vedotin hver anden uge blev der observeret maksimale serumkoncentrationer ved slutningen af infusionen, og elimination udviste et multieksponentielt fald med en t1/2z på cirka 4 til 5 dage.
English: If Grade 3 or Grade 4 neutropenia develops, refer to section 4.2.
Danish: Hvis der udvikles Grad 3 eller Grad 4 neutropeni, se pkt.
English: An exploratory intra-patient analysis showed that approximately 64% of the HL patients treated with ADCETRIS as part of the SG035-0003 clinical study experienced an improvement in clinical benefit as measured by longer progression free survival (PFS) compared with their most recent prior line of therapy.
Danish: En eksplorativ intra-patient-analyse viste, at omkring 64 % af HL-patienterne behandlet med ADCETRIS som en del af det kliniske studie SG035-003 oplevede en forbedring i klinisk gavn målt ved længere progressionsfri overlevelse (PFS) sammenlignet med deres seneste tidligere behandling.
English: At the time of last evaluation, most of the patients (76%) who experienced peripheral neuropathy had resolution or improvement of their peripheral neuropathy symptoms.
Danish: På tidspunktet for den sidste evaluering havde de fleste af patienterne (76 %), der oplevede perifer neuropati, ophør eller bedring af deres symptomer på perifer neuropati.
English: Patient characteristics n = 58
Danish: Patient-katakteristika n = 58
English: The recommended dose in combination with chemotherapy (doxorubicin [A], vinblastine [V] and dacarbazine [D] [AVD]) is 1.2 mg/kg administered as an intravenous infusion over 30 minutes on days 1 and 15 of each 28-day cycle for 6 cycles (see section 5.1).
Danish: Den anbefalede dosis i kombination med kemoterapi (doxorubicin [A], vinblastin [V] og dacarbazin [D] [AVD]) er 1,2 mg/mg administreret som en intravenøs infusion over 30 minutter på dag 1 og 15 i hver 28-dages behandlingsserie i 6 serier (se pkt.
English: Anaphylactic reactions have been reported (see section 4.4).
Danish: Anafylaktiske reaktioner er rapporteret (se pkt.
English: Primary refractory HL is defined as a failure to achieve a complete remission to, or progressed within 3 months of completing frontline therapy.
Danish: Primært refraktær sALCLdefineres som manglende opnåelse af komplet remission efter primær behandling eller progression inden for 3 måneder efter afslutning af denne.
English: Compared to patients with normal hepatic function, MMAE exposure increased approximately 2.3-fold (90% CI 1.27-4.12-fold) in patients with hepatic impairment.
Danish: Sammenlignet med patienter med normal leverfunktion er MMAE-eksponeringen øget cirka 2,3 gange (90 % CI 1,27-4,12 gange) hos patienter med nedsat leverfunktion.
English: The usual dose of Adcetris given in combination with other chemotherapy medicines is 1.2 mg/kg given every 2 weeks for 6 months.
Danish: Den sædvanlige dosis af Adcetris givet i kombination med anden kemoterapi er 1,2 mg/kg givet hver 2. uge i 6 måneder.
English: Primary Refractory to frontline therapy Refractory to most recent therapy Relapsed to most recent therapy Baseline B symptoms Stage III at initial diagnosis Stage IV at initial diagnosis a.
Danish: Primær refraktær på førstelinjebehandling Refraktært på den seneste behandling Recidiveretpå den seneste behandling Baseline B-symptomer Stadium III ved initiel diagnose Stadium IV ved initiel diagnose a.
English: The median duration of treatment for patients who discontinued due to peripheral neuropathy was 12 cycles.
Danish: Den mediane varighed af behandling for patienter, som seponerede behandlingen på grund af perifer neuropati, var 12 behandlingsserier.
English: Table 16: Sample calculations for patients receiving the recommended dose of 1.2 mg/kg of ADCETRIS for weights ranging from 60 kg to 120 kg as combination therapy or when a reduced dose is required
Danish: Tabel 16: Beregninger for patienter, der får den anbefalede dosis på 1,2 mg/kg ADCETRIS for et vægtinterval mellem 60 kg og 120 kg som kombinationsbehandling, eller når der kræves reduceret dosis
English: There was a trend of increased clearance of brentuximab vedotin in paediatric patients confirmed positive for ADAs.
Danish: Der var en tendens til øget clearance af brentuximab vedotin hos pædiatriske patienter med bekræftet positiv ADA.
English: Peripheral neuropathy led to treatment discontinuation in 15%, dose reductions in 15%, and dose delays in 17% of patients.
Danish: Perifer neuropati medførte seponering af behandlingen hos 15 %, dosisreduktioner hos 15 % og udsat dosering hos 17 % af patienterne.
English: Do not add other medicinal products to the prepared ADCETRIS infusion solution or intravenous infusion set.
Danish: Tilsæt ikke andre lægemidler til den klargjorte Adcetris-infusionsopløsning eller det intravenøse infusionssæt.
English: Grade 3 neutropenia was reported in 13% and Grade 4 neutropenia was reported in 5% of patients.
Danish: Grad 3 neutropeni blev rapporteret hos 13 % af patienterne, og Grad 4 neutropeni blev rapporteret hos 5 % af patienterne.
English: The 32 patients (53%) who did not receive subsequent SCT also received ADCETRIS for a median of 7 cycles (range, 1 to 16 cycles).
Danish: De 32 patienter (53 %), som ikke efterfølgende fik ASCT, fik også ADCETRIS i et mediant antal serier på 7 (interval 1 til 16 serier).
English: The serum and plasma pharmacokinetic characteristics of ADC and MMAE respectively following administration of brentuximab vedotin in combination with AVD were similar to that in monotherapy.
Danish: De farmakokinetiske karakteristika for henholdsvis ADC og MMAE i serum og plasma efter administration af brentuximab vedotin i kombination med AVD svarede til monoterapi.
English: Discontinue treatment
Danish: Seponer behandlingen
English: Compared to patients with normal renal function, MMAE exposure increased approximately 1.9-fold (90% CI 0.85-4.21-fold) in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Danish: Sammenlignet med patienter med normal nyrefunktion er MMAE-eksponeringen øget cirka 1,9 gange (90 % CI 0,85-4,21 gange) hos patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min).
English: A multiexponential decline in ADC serum concentrations was observed with a terminal half-life of approximately 4 to 5 days.
Danish: Et multieksponentielt fald i serumkoncentrationer af ADC blev observeret med en terminal halveringstid på cirka 4 til 5 dage.
English: Grade 4 (< 500/mm < 0.5 x 10
Danish: Grad 4 (<500/mm <0,5 x 10
English: Complete blood counts should be monitored prior to administration of each dose of treatment.
Danish: Fuldblodstal skal monitoreres før administration af hver enkelt behandlingsdosis.
English: p-value=0.035
Danish: p-værdi = 0,035
English: Infusion-related reactions
Danish: Infusionsrelaterede reaktioner
English: Tumour lysis syndrome (TLS) has been reported with ADCETRIS.
Danish: Tumorlyse-syndrom (TLS) er rapporteret ved ADCETRIS.
English: After multiple-dose, IV infusion of 1.2 mg/kg brentuximab vedotin every two weeks, steady-state trough concentrations of ADC and MMAE were achieved by Cycle 3.
Danish: Efter flere doser ved intravenøs infusion af 1,2 mg/kg brentuximab vedotin hver anden uge blev steady state-dalkoncentrationerne for ADC og MMAE opnået ved behandlingsserie 3.
English: Alanine aminotransferase/aspartate aminotransferase (ALT/AST) increased
Danish: Forhøjet alaninaminotransferase/ aspartataminotransferase (ALAT/ASAT)
English: - The active substance is brentuximab vedotin.
Danish: Aktivt stof: Brentuximab vedotin.
English: Co-administration of midazolam, a CYP3A4 substrate, with brentuximab vedotin did not alter the metabolism of midazolam; therefore brentuximab vedotin is not expected to alter the exposure to medicines that are metabolized by CYP3A4 enzymes.
Danish: Samtidig administration af midazolam, et CYP3A4-substrat, og brentuximab vedotin ændrede ikke metabolismen af midazolam; derfor forventes brentuximab vedotin ikke at ændre eksponeringen for lægemidler, der metaboliseres af CYP3A4-enzymer.
English: Pre-specified subgroup analyses of PFS per IRF were performed by patients' best response to pre-ASCT salvage therapy, HL status after frontline therapy, age, gender, baseline weight, baseline ECOG performance status, number of treatments pre-ASCT, geographic region, pre-ASCT PET status, B symptom status after failure of frontline therapy, and pre-ASCT extranodal disease status.
Danish: IRF blev udført efter patienternes bedste respons på salvage-behandling før ASCT, HL-status efter primær behandling, alder, køn, vægt ved baseline, ECOG-performancestatus ved baseline, antal behandlinger før ASCT, geografisk område, PET-status før ASCT, B-symptomstatus efter svigt af primær behandling samt status for ekstranodal sygdom før ASCT.
English: Gently invert the bag to mix the solution containing Adcetris.
Danish: Vend forsigtigt posen for at blande den opløsning, der indeholder ADCETRIS.
English: Peripheral neuropathy led to treatment discontinuation in 7%, dose reductions in 21%, and dose delays in 1% of patients.
Danish: Perifer neuropati medførte seponering af behandlingen hos 7 %, dosisreduktioner hos 21 % og udsat dosering hos 1 % af patienterne.
English: The usual dose of Adcetris given alone is 1.8 mg/kg, given once every 3 weeks for no more than one year.
Danish: Den sædvanlige dosis af Adcetris alene er 1,8 mg/kg givet en gang hver 3. uge i højst et år.
English: If SJS or TEN occur, ADCETRIS should be discontinued and appropriate medical therapy should be administered.
Danish: Hvis SJS eller TEN forekommer, skal ADCETRIS seponeres, og passende behandling iværksættes.
English: Eighteen (18) patients (18%) received 16 cycles of ADCETRIS; and the median number of cycles received was 9 (ranging from 1 to 16).
Danish: Atten (18) patienter (18 %) modtog 16 behandlingsserier ADCETRIS; og det mediane antal modtagne behandlingsserier var 9 (interval fra 1 til 16).
English: Unstratified Hazard Ratio and p-value
Danish: Ikkestratificeret Hazard Ratio og p-værdi
English: The efficacy in elderly patient population (patients ≥ 60 years of age [n = 186] [HR = 1.00, 95% CI (0.58, 1.72)] and ≥ 65 years of age [n = 122] [HR = 1.01, 95% CI (0.53, 1.94)]) and patients with no extranodal sites (n = 445) (HR = 1.04, 95% CI [0.67, 1.62]) showed no clinically meaningful difference between the two arms.
Danish: Virkningen i den ældre patientpopulation (patienter ≥ 60 år [n = 186] [HR = 1,00; 95 % CI (0,58; 1,72)] og ≥ 65 år [n = 122] [HR = 1,01; 95 % CI (0,53; 1,94)]) samt patienter uden ekstranodale steder (n = 445) (HR = 1,04; 95 % CI [0,67; 1,62]) viste ingen klinisk betydningsfuld forskel mellem de to arme.
English: The objective response rate (ORR) per IRF assessment was 75% (76 of 102 patients in the intent-to-treat [ITT] set) and tumour reduction was achieved in 94% of patients.
Danish: IRF-vurdering var 75 % (76 af 102 patienter i ‘intent-to-treat' [ITT]-gruppen), og tumorreduktion blev opnået hos 94 % af patienterne.
English: Sixty-two percent of patients had extranodal site involvement Of the 1334 patients, 664 patients were randomised to the ADCETRIS + AVD arm and 670 patients were randomised to the ABVD (doxorubicin [A], bleomycin [B], vinblastine [V] and dacarbazine [D]) arm and stratified by number of International Prognostic Factor Project (IPFP) risk factors and region.
Danish: Af de 1.334 patienter blev 664 patienter randomiseret til ADCETRIS + AVD-armen, og 670 patienter blev randomiseret til ABVD-armen (doxorubicin [A], bleomycin [B], vinblastin [V] og dacarbazin [D]) og inddelt efter antallet af IPFP-risikofaktorer (International Prognostic Factor Project) og område.
English: Keep the vial in the original carton in order to protect from light.
Danish: Opbevares i den originale ydrepakning for at beskytte mod lys.
English: Median time from HL diagnosis to first dose (range) 0.92 mo (0.1-21.4)
Danish: Mediantid fra HL-diagnose til første dosis (interval) 0,92 mdr.
English: Table 8: Summary of PFS per IRF and OS by number of risk factors in the phase 3 HL post-ASCT Study
Danish: IRF og OS efter antal risikofaktorer i HL post-ASCT fase 3studiet
English: • Extranodal disease at pre-ASCT relapse
Danish: • Ekstranodal sygdom ved recidiv før ASCT
English: ADCETRIS 50 mg powder for concentrate for solution for infusion.
Danish: ADCETRIS 50 mg pulver til koncentrat til infusionsvæske, opløsning.
English: ADCETRIS is for single use only.
Danish: Adcetris er kun til engangsbrug.
English: In the ITT population, 33% fewer patients treated with ADCETRIS + AVD in the ITT population received subsequent salvage chemotherapy (n = 66) and high-dose chemotherapy and transplant (n = 36) compared with those treated with ABVD (n = 99 and n = 54, respectively).
Danish: I ITT-populationen fik 33 % færre patienter, der fik behandling med ADCETRIS + AVD, efterfølgende salvage-kemoterapi (n = 66) samt højdosis-kemoterapi og transplantation (n = 36) sammenlignet med de patienter, der fik behandling med ABVD (henholdsvis n = 99 og n = 54).
English: ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD)(see sections 4.2 and 5.1).
Danish: ADCETRIS er indiceret til behandling af voksne patienter med ikke tidligere behandlet CD30+ Hodgkins lymfom (HL) stadie IV i kombination med doxorubicin, vinblastin og dacarbazin (AVD) (se pkt.
English: Cases of pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), some with fatal outcomes, have been reported in patients receiving ADCETRIS.
Danish: Tilfælde af lungetoksictet, herunder pneumoni, interstitiel lungesygdom og Acute Respiratory Distress Syndrome (ARDS; akut lungesvigt), nogle med dødelig udgang, er rapporteret hos patienter i behandling med ADCETRIS.
English: Co-administration of brentuximab vedotin with ketoconazole, a strong CYP3A4 and P-gp inhibitor, increased the exposure to the antimicrotubule agent MMAE by approximately 73%, and did not alter the plasma exposure to brentuximab vedotin.
Danish: Administration af brentuximab vedotin samtidigt med ketoconazol, en stærk CYP3A4 og P-gphæmmer, øgede eksponeringen for antimikrotubulus-midlet MMAE med cirka 73 % og ændrede ikke plasmaeksponeringen for brentuximab vedotin.
English: Withhold dose until toxicity returns to ≤ Grade 2 or baseline then resume treatment at the same dose and schedule .
Danish: Tilbagehold dosis, indtil toksiciteten vender tilbage til ≤ Grad 2 eller baseline, genoptag derefter behandlingen med samme dosis og plan b. Overvej
English: Patients with Stage IV disease for whom extranodal disease was reported ([n = 722] [HR = 0.69, 95% CI (0.50, 0.94)]) showed an mPFS (per IRF) benefit.
Danish: Patienter med stadie IV-sygdom, for hvem der blev rapporteret ekstranodal sygdom ([n = 722] [HR = 0,69; 95 % CI (0,50, 0,94)]), havde en fordel, hvad angår mPFS (per IRF).
English: Gently swirl the vial to aid dissolution.
Danish: Slyng forsigtigt hætteglasset for at hjælpe med opløsningen.