FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall ensure thatall healthcare professionals involved in the prescribing, dispensing, handling or administration of Bortezomib Accord are provided with educational material.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at læger og sundhedspersonale, der beskæftiger sig med ordination, udlevering, håndtering eller administration af Bortezomib Accord, forsynes med uddannelsespakken.
English: Patients in the BzTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
Danish: Patienter i henholdsvis BzTDx- og TDx-gruppen havde en gennemsnitsalder på 57 versus 56 år, 99 % versus 98 % af patienterne var kaukasere og 58 % versus 54 % var mænd.
English: Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib Accord
Danish: Grad ≥ 3 ikke- hæmatologisk toksicitet, som anses for relateret til Bortezomib Accord
English: It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of bortezomib therapy.
Danish: Det anbefales ligeledes, at responderende patienter, som ikke opnår fuldstændig remission, gennemgår i alt 8 behandlingscyklusser med bortezomib.
English: Early and regular monitoring for symptoms of treatment-emergent neuropathy with neurological evaluation should be considered in patients receiving bortezomib in combination with medicinal products known to be associated with neuropathy (e.g. thalidomide) and appropriate dose reduction or treatment discontinuation should be considered.
Danish: Tidlig og regelmæssig monitorering for symptomer på behandlingsrelateret neuropati og neurologisk evaluering skal overvejes hos patienter, der får bortezomib i kombination med lægemidler, der vides at være forbundet med neuropati (fx thalidomid), og passende dosisreduktion eller behandlingsseponering skal overvejes.
English: Table 16: Efficacy results from study LYM-3002
Danish: Tabel 16: Effektresultater fra studie LYM-3002
English: Male patients and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Danish: Mandlige patienter og kvindelige fertile patienter skal anvende sikker kontraception under behandlingen og i 3 måneder efter behandlingen.
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BzR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Danish: Yderligere bivirkninger, som blev identificeret i forbindelse med brug af kombinationsbehandling (BzR-CAP), var hepatitis B-infektion (< 1 %) og myokardie-iskæmi (1,3 %).
English: Angioedema#, Hypersensitivity*
Danish: Angioødem#, overfølsomhed*
English: ** Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc; *** Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medicinal products, and not bedridden.
Danish: ** Instrumentel ADL: Dækker madlavning, indkøb af dagligvarer eller tøj, brug af telefon, håndtering af penge osv. *** Personlig ADL: Dækker badning, på- og afklædning, spisning, toiletbesøg, indtagelse af medicin og oppegående.
English: Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Danish: Gastrointestinal toksicitet, inklusive kvalme, diaré, opkastning og forstoppelse, er meget almindelig ved behandling med bortezomib.
English: Normal liver function should be confirmed and caution should be exercised in patients receiving oral hypoglycaemics (see section 4.5).
Danish: Normal leverfunktion skal bekræftes, og der skal udvises forsigtighed ved patienter, der behandles med orale hypoglykæmika (se pkt.
English: d Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
Danish: d Logrank-test justeret for stratifikationsfaktorer: ISS-score og antal tidligere linjer.
English: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Danish: Normal (CrCl ≥ 60 ml/min/1,73 m2, n=12), Mild (CrCl=40-59 ml/min/1,73 m2, n=10), Moderat (CrCl=20-39 ml/min/1,73 m2, n=9) og Alvorlig (CrCl < 20 ml/min/1,73 m2, n=3).
English: The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) are made comparable with respect to confounding factors by individually pairing study subjects.
Danish: "Matchet par"-analysen er en statistisk metode i hvilken patienter i behandlingsgruppen (f.eks. bortezomib i kombination med dexamethason) og patienter i sammenligningsgruppen (f.eks. bortezomib) gøres sammenlignelige med hensyn til confounding faktorer ved individuelt at sammensætte forsøgspersonerne i par.
English: Intent to Treat Populationb n=74
Danish: Intention to treat-populationb n=74
English: • If, after Bortezomib Accord has been held, the toxicity does not resolve, as defined above, then Bortezomib Accord must be discontinued.
Danish: • Hvis toksiciteten ikke forsvinder efter, at Bortezomib Accord har været indstillet som defineret ovenfor, skal Bortezomib Accord seponeres.
English: Progression Free Survival, months
Danish: Progressionsfri overlevelse, måneder 8,0
English: Reduce Bortezomib Accord to 0.7 mg/m2 in the first treatment cycle.
Danish: Reducer Bortezomib Accord til 0,7 mg/m2 i første behandlingscyklus.
English: d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+)
Danish: d p-værdi fra Cochran-Mantel-Haenszel chi-square-testen justeret for stratifikationsfaktorer; analyse ud fra behandling udelukker opdeling på tidligere behandling * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) TTP = Tid til progression
English: Also included are adverse drug reactions identified in the BzR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Danish: Den inkluderer desuden bivirkninger, som blev identificeret i BzR-CAP-armen, og som af investigatorerne blev anset for at have mindst en mulig eller sandsynlig årsagssammenhæng med bortezomib, baseret på historiske data i myelomatose-studierne.
English: The majority of the patients in both groups completed treatment, 80% in the BzR-CAP group and 82% in the R-CHOP group.
Danish: Størstedelen af patienterne i begge grupper fuldførte behandlingen, 80 % i BzR-CAP-gruppen og 82 % i R-CHOP-gruppen.
English: Bortezomib Accord should not be administered intrathecally.
Danish: Bortezomib Accord må ikke administreres intratekalt.
English: Fall, Contusion
Danish: Fald, kontusion
English: System Organ Class
Danish: Systemorganklasse Frekvens
English: h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Danish: h Inkluderer alle radiologiske CR+CRu+PR efter IRC uanset verificering ved knoglemarv og
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 en optimal respons på behandlingen med bortezomib alene, få højdosis dexamethason sammen med bortezomib.
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 dagen før og efter administration af bortezomib.
English: An open label, randomised, Phase III non-inferiority study compared the efficacy and safety of the subcutaneous administration of bortezomib versus the intravenous administration.
Danish: Der er gennemført et åbent, randomiseret, fase III noninferiority-studie til sammenligning af effekt og sikkerhed af subkutan administration af bortezomib versus intravenøs administration.
English: The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the Bortezomib Accord 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 Accord 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: Once weekly Bortezomib Accord (cycles 5-9)
Danish: Bortezomib Accord en gang om ugen (cyklus 5-9)
English: 42.9% and 10.4% of patients in the BzR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
Danish: Henholdsvis 42,9 % og 10,4 % af patienterne i BzR-CAP-armen var i alderen 65-74 år og ≥ 75 år.
English: Instructions for reconstitution Bortezomib Accord must be reconstituted by a healthcare professional.
Danish: Instruktioner for rekonstitution Bortezomib Accord skal rekonstitueres af sundhedspersonale.
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: Bortezomib Accord contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Danish: Bortezomib Accord indeholder det aktive stof bortezomib, som er en såkaldt proteasomhæmmer.
English: Your doctor will work out your dose of Bortezomib Accord according to your height and weight (body surface area).
Danish: Din læge vil bestemme dosis ud fra din højde og vægt (areal af legemsoverflade).
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 chi2 -test, med IPI og sygdomsstadie som stratifikationsfaktorer.
English: In the BzR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Danish: I BzR-CAP-gruppen fik 22,5 % af patienterne trombocyttransfusioner sammenlignet med 2,9 % af patienterne i R-CHOP-gruppen.
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 dispenseret fra kravet om at fremlægge resultaterne af studier med bortezomib i alle undergrupper af den pædiatriske population ved myelomatose og ved mantlecelle-lymfom (se pkt.
English: The median duration of complete response was 42.1 months in the BzR-CAP group compared with 18 months in the R-CHOP group.
Danish: Den mediane varighed af komplet respons var 42,1 måneder i BzR-CAP-gruppen sammenlignet med 18 måneder i R-CHOP-gruppen.
English: Bortezomib treatment is commonly associated with orthostatic/postural hypotension.
Danish: Behandlingen med bortezomib forbindes almindeligvis med ortostatisk/postural hypotension.
English: You may also be given Bortezomib Accord together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Danish: Du kan ligeledes få Bortezomib Accord sammen med lægemidlerne pegyleret liposomal doxorubicin eller dexamethason.
English: A statistically significant benefit (p < 0.001) in favour of the BzR-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 BzR-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: Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (BzR-CAP)
Danish: Kombinationsbehandling med rituximab, cyclophosphamid, doxorubicin og prednison (BzR-CAP)
English: The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BzR-CAPgroup and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (BzR-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 BzR-CAP-gruppen og 5,0 % i R-CHOP-gruppen) såvel som blødningshændelser af grad 3 og højere (BzR-CAP: 4 patienter [1,7 %]; R-CHOP: 3 patienter [1,2 %]).
English: Six bortezomib cycles are recommended, although for patients with a response first documented at cycle 6, two additional bortezomib cycles may be given.
Danish: Seks bortezomib-cyklusser anbefales, men patienter med et respons, som først dokumenteres ved cyklus 6, kan gives yderligere to bortezomib-cyklusser.
English: 2 years (for Bortezomib Accord 1 mg) 3 years (for Bortezomib Accord 3.5 mg)
Danish: Hætteglas inden anbrud 2 år (for Bortezomib Accord 1 mg) 3 år (for Bortezomib Accord 3,5 mg)
English: Table 8 Adverse reactions in patients with Mantle cell lymphoma treated with BzR-CAP in a clinical trial
Danish: Tabel 8: Bivirkninger hos patienter med mantle-celle-lymfom, som blev behandlet med BzR-CAP i et klinisk studie
English: For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib Accord as outlined in Table 1.
Danish: I tilfælde af bortezomib-relateret neuropatisk smerte og/eller perifer neuropati indstilles og/eller modificeres Bortezomib Accord-behandlingen som beskrevet i tabel 1.
English: Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001)
Danish: Bortezomib-kombinationsbehandling med pegyleret liposomal doxorubicin (studie DOXILMMY-3001)
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) (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 sammen med dexamethason over bortezomib som monoterapi.
English: In particular, tell your doctor if you are using medicines containing any of the following active substances: - ketoconazole, used to treat fungal infections - ritonavir, used to treat HIV infection - rifampicin, an antibiotic used to treat bacterial infections - carbamazepine, phenytoin or phenobarbital used to treat epilepsy - St. John's Wort (Hypericum perforatum), used for depression or other conditions - oral antidiabetics
Danish: Særligt skal du fortælle lægen, hvis du bruger medicin, som indeholder følgende aktive stoffer: - ketoconazol, som bruges til behandling af svampeinfektioner - ritonavir, bruges til behandling af Hiv-infektion - rifampicin, et antibiotikum, som bruges til at behandle bakterie-infektioner - carbamazepin, phenytoin eller phenobarbital til behandling af epilepsi - perikon (Hypericum perforatum), naturmedicin som bruges mod depression eller andre lidelser - tabletter til behandling af sukkersyge (diabetes)
English: Subcutaneous or Intravenous use.
Danish: Kun til subkutan eller intravenøs anvendelse.
English: Since dialysis may reduce bortezomib concentrations, Bortezomib Accord should be administered after the dialysis procedure (see section 5.2).
Danish: Da dialyse kan reducere koncentrationen af bortezomib, bør Bortezomib Accord gives efter dialyse (se pkt.
English: The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV
Danish: Demografiske og baseline-sygdomskarakteristika var generelt afbalanceret mellem de to behandlingsarme: Den mediane patientalder var 66 år, 74 % var mænd, 66 % var kaukasere og 32 % asiater, 69 % af patienterne havde et positivt knoglemarvsaspirat og/eller en positiv knoglemarvsbiopsi for MCL, 54 % af patienterne havde en IPI-score (International Prognostic Index) på ≥ 3, og 76 % var i sygdomsstadie IV. Behandlingens varighed (median=17 uger) og varigheden af opfølgningen (median=40 måneder) var sammenlignelige i de to behandlingsarme.
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: • Increased appetite
Danish: Nedsat appetit
English: Leukopenia*, Lymphopenia*
Danish: Almindelig Leukopeni*, lymfopeni*
English: Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*,C-reactive protein increased
Danish: Hyperbilirubinæmi*, abnorme proteinanalyser*, vægtstigning, abnorm blodprøve*, forhøjet C-reaktivt protein
English: Bortezomib Accord is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Danish: Bortezomib Accord gives intravenøst eller subkutant på dag 1, 4, 8 og 11, fulgt af en ‘hvileperiode' uden behandling.
English: Response Rate at 8 cycles n (%)
Danish: Responsrate efter 8 cyklusser n (%)
English: • Bortezomib Accord 3.5 mg can be administered both intravenously and subcutaneously, while Bortezomib Accord 1 mg can be administered only intravenously
Danish: • at Bortezomib Accord 3,5 mg kan administreres enten intravenøst eller subkutant, mens Bortezomib Accord 1 mg kun må administreres intravenøst
English: Median OS was 90.7 months for the BzR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
Danish: Den mediane OS var 90,7 måneder for BzR-CAP -gruppen sammenlignet med 55,7 måneder for R-CHOP-gruppen (HR = 0,66; p = 0,001).
English: There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mental cell lymphona.
Danish: Der er ikke data, der tyder på, at dosisjustering er nødvendig hos patienter med myelomatose eller mantle-celle-lymfom, der er ældre end 65 år.
English: Events n (%) Mediana (95% CI)
Danish: Hændelser n (%) Mediana (95 % CI)
English: • advice on method of administration for both intravenous and subcutaneous use, including the need to rotate injection sites for subcutaneous use
Danish: • rådgivning om intravenøs og subkutan administration, herunder at der bør skiftes mellem injektionssteder ved subkutan anvendelse
English: Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy
Danish: Tabel 9: Forekomst af perifer neuropati under induktionsbehandling efter toksicitet og behandlingsseponering på grund af perifer neuropati
English: Bortezomib Accord might cause tiredness, dizziness, fainting, or blurred vision.
Danish: Bortezomib Accord kan forårsage træthed, svimmelhed, besvimelse og uklart/sløret syn.
English: Treatment was administered for a maximum of 9 cycles (approximately 54 weeks) and was discontinued early for disease progression or unacceptable toxicity.
Danish: 54 uger) og blev seponeret før tid ved sygdomsprogression eller uacceptabel toksicitet.
English: Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each Bortezomib Accord treatment cycle.
Danish: Melphalan og prednison bør begge gives oralt på dag 1, 2, 3 og 4 i den første uge af hver behandlingscyklus med Bortezomib Accord.
English: Both in patients who were refractory to their last prior therapy and those who were not refractory, overall survival was significantly longer and response rate was significantly higher on the bortezomib arm.
Danish: som var refraktære over for den seneste behandling, og de, der ikke var refraktære, var den samlede overlevelse signifikant længere, og responsraten var signifikant højere i bortezomib-gruppen.
English: Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib bortezomib intravenous arm bortezomib subcutaneous arm
Danish: Tabel 15: Oversigt over effektanalyser til sammenligning af subkutan og intravenøs administration af bortezomib bortezomib intravenøs gruppe bortezomib subkutan gruppe
English: In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with bortezomib+melphalan+prednisone compared with melphalan+prednisone (14% versus 4% respectively).
Danish: I fase III-studiet med hidtil ubehandlede myelomatosepatienter var den samlede forekomst af herpes zoster-reaktivering større hos patienter behandlet med bortezomib+melphalan+prednison sammenlignet med melphalan+prednison (14 % versus 4 %).
English: Response Rate at 4 cycles n (%)
Danish: Responsrate efter 4 cyklusser n (%)
English: Absorption Following intravenous bolus administration of a 1.0 mg/m2 and 1.3 mg/m2 dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Danish: Absorption Efter intravenøs bolusindgift af en dosis på 1,0 mg/m2 og 1,3 mg/m2 til 11 patienter med myelomatose og kreatininclearance-værdier på mere end 50 ml/min., var de gennemsnitlige maksimale plasmakoncentrationer af bortezomib efter første dosis henholdsvis 57 og 112 ng/ml.
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: • to remind that patients receiving Bortezomib Accord in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
Danish: • for at minde patienter, der modtager Bortezomib Accord sammen med thalidomid, om, at de skal overholde det svangerskabsforebyggende program for thalidomid, og med reference til produktresuméet for thalidomid for yderligere oplysninger.
English: • Platelet counts should be ≥ 70 x 109/l and the absolute neutrophils count should be ≥ 1.0 x 109/l
Danish: • Trombocyttal skal være ≥ 70 x 109/l, og absolut neutrofiltal skal være ≥ 1,0 x 109/l
English: • a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate Bortezomib Accord dose.
Danish: • et redskab til beregning af dosis, hvor den ordinerende læge kan indlæse patientens højde og vægt for ud fra disse at beregne arealet af legemsoverfladen og derved fastsætte en passende dosering af Bortezomib Accord.