FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatitis B Virus (HBV) reactivation and infection When rituximab is used in combination with bortezomib, HBV screening must always be performed in patients at risk of infection with HBV before initiation of treatment.
Danish: Hepatitis B-virus (HBV)-reaktivering og -infektion Når rituximab anvendes i kombination med bortezomib, skal patienter, som har risiko for infektion med HBV, altid screenes for HBV, inden behandlingen startes.
English: In the unlikely event of an overdose, your doctor will monitor you for side effects.
Danish: Skulle overdosering mod al forventning ske, vil din læge overvåge dig for tegn på bivirkninger.
English: Rare cases of hepatic failure have been reported in patients receiving bortezomib and concomitant medicinal products and with serious underlying medical conditions.
Danish: Der er rapporteret sjældne tilfælde af leversvigt hos patienter, der får bortezomib og andre lægemidler samtidig og med alvorlige tilgrundliggende helbredsproblemer.
English: The concentration of the resulting solution will be 1 mg/ml.
Danish: Den færdige koncentration i opløsningen vil være 1 mg/ml.
English: It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness.
Danish: Det anbefales, at patienter monitoreres omhyggeligt for symptomer på neuropati, f.eks. brændende fornemmelse, hyperæstesi, hypæstesi, paræstesi, ubehag, neuropatiske smerter eller svækkelse.
English: Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Danish: Tabel 1: Anbefalede* dosisændringer ved bortezomib-relateret neuropati Sværhedsgrad af neuropati
English: Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Danish: Graden bestemt i henhold til det amerikanske National Cancer Institute's Common Toxicity Criteria (CTCAE) version 4.0.
English: • advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use
Danish: • rådgivning om intravenøs og subkutan administration, herunder at der bør skiftes mellem injektionssteder ved s.c. anvendelse
English: Orthostatic/postural hypotension was not acutely related to bolus infusion of bortezomib.
Danish: Ortostatisk/postural hypotension var ikke akut relateret til bolusinjektion af bortezomib.
English: Bortezomib was positive for clastogenic activity (structural chromosomal aberrations) in the in vitro chromosomal aberration assay using Chinese hamster ovary (CHO) cells at concentrations as low as 3.125 μg/ml, which was the lowest concentration evaluated.
Danish: Bortezomib var positivt for klastogen aktivitet (strukturelle kromosomafvigelser) i in vitro-analysen af kromosomafvigelser ved hjælp af ovarieceller fra kinesiske hamstre (CHO) i koncentrationer så lave som 3,125 µg/ml, som var den laveste vurderede koncentration.
English: Progression free survival (IRC)a Events n (%)
Danish: Progressionsfri overlevelse (IRC)a Hændelser n (%)
English: - The other ingredient is mannitol (E421).
Danish: - Øvrige indholdsstoffer: Mannitol (E421).
English: Normal liver function should be confirmed and caution should be exercised in patients receiving oral hypoglycemics (see section 4.5).
Danish: Normal leverfunktion skal bekræftes, og der skal udvises forsigtighed ved patienter, der behandles med orale hypoglæmika (se pkt.
English: In the Phase II study, patients who did not obtain an optimal response to therapy with bortezomib alone were able to receive high-dose dexamethasone in conjunction with bortezomib.
Danish: I fase II-studiet kunne de patienter, som ikke havde et optimalt respons på behandlingen med bortezomib alene, få højdosis-dexamethason sammen med bortezomib.
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).
Danish: Hvis du får thalidomid, skal du være særlig opmærksom på kravene til graviditetsprøver og prævention (se under "Graviditet og amning" i dette punkt).
English: Response rate populatione n=668
Danish: Responsrate populatione n = 668
English: Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Danish: Efter en intravenøs bolus- eller subkutan injektion af en dosis på 1,3 mg/m2 hos patienter med myelomatose (n=14 i den intravenøse gruppe, n=17 i den subkutane gruppe) sås samme totale systemiske eksponering efter gentagne doser (AUClast) for subkutan og intravenøs administration.
English: The incidence of all grade peripheral neuropathy with bortezomib administered intravenously was lower in the historical studies with bortezomib administered intravenously than in study MMY-3021.
Danish: Forekomsten af alle grader af perifer neuropati efter intravenøs administration af bortezomib var lavere i de ældre studier med bortezomib administreret intravenøst end i studie MMY-3021.
English: Be sure that the correct dose is being given for the subcutaneous route of administration (2.5 mg/ml).
Danish: Kontroller, at den korrekte dosis anvendes til subkutan administration (2,5 mg/ml).
English: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Prior to initiating a new cycle of therapy:
Danish: Dosisjusteringer under behandlingen af patienter med tidligere ubehandlet mantle-celle-lymfom Før påbegyndelse af en ny behandlingscyklus:
English: OR; 95% CI; P valuea
Danish: OR; 95 % CI; p-værdia
English: In the Phase III study, treatment with bortezomib led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
Danish: I fase III-studiet førte behandlingen med bortezomib til signifikant længere tid indtil progression, en signifikant længere overlevelse og en signifikant højere responsrate sammenlignet med behandling med dexamethason (se tabel 14) hos alle patienter samt hos patienter, som tidligere havde fået én behandling.
English: The mean platelet count nadir measured was approximately 40% of baseline in the single-agent multiple myeloma studies and 50% in the MCL study.
Danish: Nadir for det gennemsnitlige trombocyttal var ca. 40 % af værdien ved baseline i myelomatose-studier med monoterapi og 50 % i MCL-studiet.
English: The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the bortezomib containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%).
Danish: Følgende bivirkninger (grad ≥ 3) blev observeret med en hyppigere forekomst i behandlingsregimet med bortezomib sammenlignet med et historisk kontrolstudie, i hvilket baggrundsregimet blev givet alene: I blok 1 perifer sensorisk neuropati (3 % kontra 0 %), ileus (2,1 % kontra 0 %), hypoksi (8 % kontra 2 %).
English: At least 72 hours should elapse between consecutive doses of Bortezomib SUN.
Danish: Der skal gå mindst 72 timer mellem 2 doser Bortezomib SUN.
English: Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported during bortezomib treatment.
Danish: Der er rapporteret akut udvikling eller forværring af kongestiv hjerteinsufficiens og/eller ny forekomst af nedsat ejektionsfraktion fra venstre ventrikel ved behandling med bortezomib.
English: Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with BzmbR-CAP in a clinical trial
Danish: Tabel 8: Bivirkninger hos patienter med mantle-celle-lymfom, som blev behandlet med BzmbR-CAP i et klinisk studie
English: Patients who did not obtain an optimal response (less than Complete Response [CR]) to therapy with bortezomib alone after 4 cycles were allowed to receive dexamethasone 20 mg daily on the day of and after bortezomib administration.
Danish: Patienter, der ikke opnåede et optimalt respons (mindre end et komplet respons [CR]) på behandlingen med bortezomib alene efter 4 cyklusser, fik desuden dexamethason 20 mg dagligt samme dag som og dagen efter administration af bortezomib.
English: A pre-treatment chest radiograph is recommended to serve as a baseline for potential post-treatment pulmonary changes.
Danish: Thoraxrøntgen anbefales før behandling for at tjene som udgangspunkt for potentielle lungeforandringer efter behandling.
English: In the BzmbR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Danish: I BzmbR-CAP-gruppen fik 22,5 % af patienterne trombocyttransfusioner sammenlignet med 2,9 % af patienterne i R-CHOP-gruppen.
English: Overall, bortezomib was administered for the treatment of multiple myeloma in 3,974 patients.
Danish: Samlet blev bortezomib givet til 3.974 patienter til behandling af myelomatose.
English: Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib.
Danish: Patienter, der udviklede ortostatisk hypotension ved bortezomib (som intravenøs injektion), viste ikke tegn på ortostatisk hypotension før behandlingen med bortezomib.
English: Table 13: Efficacy results from study MMY-3010 Endpoints
Danish: Tabel 13: Effektresultater fra studiet MMY-3010 Endepunkter
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11
Danish: Dag 1, 2, 3, 4 Dag 8, 9, 10, 11
English: The incidence of death on treatment was 5% in the subcutaneous treatment group and 7% in the intravenous treatment group.
Danish: Forekomsten af død efter behandlingen var 5 % i den subkutane gruppe og 7 % i den intravenøse gruppe.
English: Bortezomib may have a moderate influence on the ability to drive and use machines.
Danish: Bortezomib påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Caution should be exercised when bortezomib is combined with CYP3A4 or CYP2C19 substrates (see section 4.5).
Danish: Der skal udvises forsigtighed, når bortezomib kombineres med CYP3A4- eller CYP2C19substrater (se pkt.
English: A statistically significant benefit (p < 0.001) in favour of the BzmbR-CAP treatment group over the R-CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months).
Danish: Der blev observeret en statistisk signifikant fordel (p < 0,001) for BzmbR-CAP-gruppen i forhold til R-CHOP-gruppen for TTP (median 30,5 kontra 16,1 måneder), TNT (median 44,5 kontra 24,8 måneder) og TFI (median 40,6 kontra 20,5 måneder).
English: Posology modification
Danish: Dosisændringer
English: Grade 2 with pain or Grade 3 (severe symptoms; limiting self care ADL***)
Danish: Grad 2 med smerter eller grad 3 (svære symptomer, der begrænser personlig pleje (personlig ADL***)
English: Table 2: Recommended posology for Bortezomib SUN in combination with melphalan and prednisone Twice weekly Bortezomib SUN (cycles 1-4)
Danish: Tabel 2: Anbefalet dosering for Bortezomib SUN i kombination med melphalan og prednison Bortezomib SUN to gange om ugen (cyklus 1-4)
English: Inhibition of the proteasome results in cell cycle arrest and apoptosis.
Danish: Hæmning af proteasom resulterer i cellecyklusstop og apoptose.
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for bortezomib the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing bortezomib is unchanged subject to the proposed changes to the product information.
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne På baggrund af de videnskabelige konklusioner for bortezomib er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder bortezomib, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells and MCL cells, the complications of tumour lysis syndrome may occur.
Danish: Da bortezomib er et cytotoksisk stof, som hurtigt kan dræbe maligne plasmaceller og MCL-celler, kan der opstå komplikationer i form af tumorlysesyndrom.
English: The benefit/risk ratio should be considered prior to continuing bortezomib therapy.
Danish: Forholdet mellem fordele og risici skal overvejes, før behandlingen med bortezomib fortsætter.
English: 1.3 The reconstituted product is preservative free and should be used immediately after preparation.
Danish: 1.3 Det rekonstituerede produkt er uden konserveringsmidler og skal anvendes umiddelbart efter præparation.
English: g P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
Danish: g p-værdi fra Cochran-Mantel-Haenszel chi-square-test med IPI og sygdomsstadie som stratifikationsfaktorer.
English: • Reconstitution, dosing and administration booklet
Danish: • Brochure om rekonstitution, dosering og administration
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 AF IKKEANVENDT LÆGEMIDDEL SAMT AFFALD HERAF
English: Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration.
Danish: Profylaktisk brug af granulocyt-kolonistimulerende faktorer skal overvejes i tilfælde af gentagne udsættelser af cyklusadministration.
English: Complete blood counts (CBC) with differential and including platelet counts should be frequently monitored throughout treatment with bortezomib.
Danish: Komplet blodtælling (CBC) med differentialtælling og inklusive trombocyttal skal gennemføres hyppigt under behandlingen med bortezomib.
English: - Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
Danish: - Sprøjt opløsningen som en 35 sek. intravenøs bolusinjektion gennem et perifert eller centralt intravenøst kateter ind i en vene.
English: d Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
Danish: d Log-rank-test justeret for stratifikationsfaktorer: ISS-score og antal tidligere linjer.
English: • Additional risk minimisation measures In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Danish: I de enkelte medlemslande skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om format og indhold af uddannelsespakken.
English: The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Danish: Analysen påviste forbedret ORR (CR+PR) (oddsratio 3,769; 95 % CI 2,045-6,947; p < 0,001), PFS (hazard-ratio 0,511; 95 % CI 0,309-0,845; p = 0,008), TTP (hazard-ratio 0,385; 95 % CI 0,212-0,698; p = 0,001) for bortezomib sammen med dexamethason over bortezomib som monoterapi.
English: The solution should be injected subcutaneously, at a 45-90° angle.
Danish: Opløsningen skal indgives subkutant i en vinkel på 45-90°.
English: Antiviral prophylaxis is recommended in patients being treated with bortezomib.
Danish: Antiviral profylakse anbefales hos patienter, der bliver behandlet med bortezomib.
English: Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Danish: Tabel 15: Oversigt over effektanalyser til sammenligning af subkutan og intravenøs administration af bortezomib
English: For dose adjustments, see Table 5 below.
Danish: Se tabel 5 nedenfor vedrørende dosisjusteringer.
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BzmbR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Danish: Yderligere bivirkninger, som blev identificeret i forbindelse med brug af kombinationsbehandling (BzmbR-CAP), var hepatitis Binfektion (< 1 %) og myokardieiskæmi (1,3 %).
English: The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BzmbR-CAP group and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (BzmbR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
Danish: De to behandlingsgrupper var sammenlignelige, hvad angår den samlede forekomst af alle grader af blødningshændelser (6,3 % i BzmbR-CAP-gruppen og 5,0 % i R-CHOP-gruppen) såvel som blødningshændelser af grad 3 og højere (BzmbR-CAP: 4 patienter [1,7 %]; R-CHOP: 3 patienter [1,2 %]).
English: Table 7: Adverse reactions in patients with Multiple Myeloma treated with bortezomib in clinical trials, and all post-marketing adverse reactions regardless of indication#
Danish: Tabel 7: Bivirkninger hos patienter med myelomatose behandlet med bortezomib i kliniske studier samt alle bivirkninger efter markedsføring, uanset indikation#
English: Haematological toxicity - ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μl
Danish: Hæmatologisk toksicitet - ≥ Grad 3-neutropeni med feber, grad 4neutropeni, som varer mere end 7 dage, trombocyttal < 10 x 109 celler/l
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Danish: Thalidomid er et kendt teratogent lægemiddel, der medfører livstruende medfødte misdannelser hos mennesker.
English: Bortezomib was not genotoxic when tested in the in vitro mutagenicity assay (Ames assay) and in vivo micronucleus assay in mice.
Danish: Bortezomib var ikke genotoksisk i in vitro-analyser af mutagenicitet (Ames' test) og in vivo-analyser af mikronucleus hos mus.
English: The reconstituted solution is clear and colourless, with a final pH of 4 to 7.
Danish: Den rekonstituerede opløsning er klar og farveløs med en pH-værdi på 4-7.
English: The European Medicines Agency has waived the obligation to submit the results of studies with bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med bortezomib i alle undergrupper af den pædiatriske population ved myelomatose og ved mantlecelle-lymfom (se pkt.
English: Bortezomib treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Danish: Behandlingen med bortezomib forbindes meget ofte med hæmatologisk toksicitet (trombocytopeni, neutropeni og anæmi).
English: Induction Transplant Regimens Graph shall contain the following key elements:
Danish: Grafen over induktionstransplantationsregimerne skal indeholde følgende nøgleelementer:
English: The median duration of complete response was 42.1 months in the BzmbR-CAP group compared with 18 months in the R-CHOP group.
Danish: Den mediane varighed af komplet respons var 42,1 måneder i BzmbR-CAP-gruppen sammenlignet med 18 måneder i R-CHOP-gruppen.
English: Instructions for reconstitution Bortezomib SUN must be reconstituted by a healthcare professional.
Danish: Instruktioner for rekonstitution Bortezomib SUN skal rekonstitueres af sundhedspersonale.
English: Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
Danish: Bortezomib forårsager reduktion af tumorvækst in vivo i mange prækliniske tumormodeller, inklusive i myelomatose.
English: This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Danish: Denne interimanalyse viste en TTP-risikoreduktion på 45 % (95 % CI, 29-57 %, p < 0,0001) for patienter behandlet med kombinationsbehandlingen bortezomib og pegyleret liposomal doxorubicin.
English: Bortezomib SUN is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Danish: Bortezomib SUN gives intravenøst eller subkutant på dag 1, 4, 8 og 11, fulgt af en ‘hvileperiode' uden behandling.
English: These effects have been observed in patients with multiple myeloma affected by an advanced osteolytic disease and treated with bortezomib.
Danish: Disse virkninger er set hos patienter med myelomatose påvirket af en fremskreden osteolytisk sygdom, der har været behandlet med bortezomib.
English: Developmental toxicity studies in the rat and rabbit have shown embryo-fetal lethality at maternally toxic doses, but no direct embryo-foetal toxicity below maternally toxic doses.
Danish: Udviklingstoksicitetsstudier på rotter og kaniner har vist embryo-/fosterdødelighed ved maternelt toksiske doser, men ingen direkte embryo-/fostertoksicitet ved ikke-maternelt toksiske doser.
English: Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
Danish: Der sås også hyppigere forekomst af infektioner med grad ≥ 3 neutropeni (24 % kontra 19 % i blok 1 og 22 % kontra 11 % i blok 2), forhøjet ALAT (17 % kontra 8 % i blok 2), hypokaliæmi (18 % kontra 6 % i blok 1 og 21 % kontra 12 % i blok 2) samt hyponatriæmi (12 % kontra 5 % i blok 1 og 4 % kontra 0 % i blok 2).
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke-anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Caution is advised when treating patients with a history of syncope receiving medicinal products known to be associated with hypotension; or who are dehydrated due to recurrent diarrhoea or vomiting.
Danish: Der skal udvises forsigtighed ved behandling af patienter med tidligere synkope, der får lægemidler, som er kendt for at være forbundet med hypotension, eller patienter, som er dehydreret pga. tilbagevendende diarré eller opkastning.
English: In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
Danish: In vitro -studier viser, at bortezomib er en svag hæmmer af cytochrom P450 (CYP)-isozymer 1A2, 2C9, 2C19, 2D6 og 3A4.
English: The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration.
Danish: Den rekonstituerede opløsning skal inspiceres visuelt for partikler og misfarvning før anvendelse.
English: Patients should be instructed to seek medical advice if they experience symptoms of dizziness, light-headedness or fainting spells.
Danish: Patienterne skal instrueres i at søge læge, hvis de oplever symptomer som svimmelhed, uklarhed eller besvimelse.
English: With a median duration of follow-up of 40 months, median OS (56.3 months in the R-CHOP group, and not reached in the BzmbR-CAP group) favoured the BzmbR-CAP group, (estimated HR=0.80; p=0.173).
Danish: Med en median opfølgningsvarighed på 40 måneder var den mediane OS (56,3 måneder i R-CHOP-gruppen og ikke nået i BzmbR-CAP-gruppen) højest i BzmbR-CAPgruppen (estimeret HR=0,80; p=0,173).
English: Melphalan (9 mg/m2) and prednisone (60 mg/m2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Danish: Melphalan (9 mg/m2) og prednison (60 mg/m2) gives gennem munden på dag 1, 2, 3 og 4 i den første uge af hver behandlingscyklus.