FrancophonIA/ELRC3.0 huggingface dataset:
English: One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib-containing regimen were retreated upon progression.
Danish: 130 patienter (≥ 18 år) med myelomatose, som tidligere havde haft minimim partielt respons på et bortezomib-holdigt regime, blev genbehandling ved progression.
English: For subcutaneous or intravenous use after reconstitution For single use.
Danish: Til subkutan eller intravenøs anvendelse efter rekonstitution.
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 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.
English: Six percent of patients had an adverse local reaction to subcutaneous administration, mostly redness.
Danish: Det rapporteredes, at 6 % fik en lokal reaktion ved subkutan administration, for det meste rødmen.
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+)
English: Instructions for reconstitution Bortezomib must be reconstituted by a healthcare professional.
Danish: Instruktioner for rekonstitution Bortezomib skal rekonstitueres af sundhedspersonale.
English: This medicine contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Danish: Denne medicin indeholder det aktive stof bortezomib, som er en såkaldt proteasomhæmmer.
English: In the BR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Danish: I BR-CAP-gruppen fik 22,5 % af patienterne trombocyttransfusioner sammenlignet med 2,9 % af patienterne i R-CHOP-gruppen.
English: Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours.
Danish: Geometrisk gennemsnit (% CV) for clearance var 7,79 (25 %) l/t/m2, fordelingsvolumen ved steady state var 834 (39 %) l/m og eliminationshalveringstiden var 100 (44 %) timer.
English: Reduce bortezomib to 0.7 mg/m in the first treatment cycle.
Danish: Reducér bortezomib til 0,7 mg/m i den første behandlingscyklus.
English: Dexamethasone was administered in combination with bortezomib to 83 patients in cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
Danish: Dexamethason blev administreret i kombination med bortezomib til 83 patienter i cyklus 1, mens yderligere 11 patienter fik dexamethason i løbet af efterfølgende bortezomib-behandlingscyklusser.
English: At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m
Danish: Mindst 6 måneder efter den forudgående behandling initieredes bortezomib med den senest tålte dosis på 1,3 mg/m
English: Progression Free Survival, months (95% CI)
Danish: Progressionsfri overlevelse, måneder (95 % CI)
English: In addition, the incidence of grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
Danish: Desuden var forekomsten af ≥ grad 3 perifere neuropatier 10 % lavere, og seponeringsraten grundet perifer neuropati var 8 % lavere i den subkutane gruppe sammenlignet med den intravenøse gruppe.
English: These effects have been observed in patients with multiple myeloma affected by an advanced osteolytic disease and treated with bortezomib.
Danish: Disse effekter er blevet observeret hos patienter med myelomatose påvirket af en fremskreden osteolytisk sygdom, der har været behandlet med 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 open-label, randomiseret, fase III non-inferiority studie til sammenligning af effekt og sikkerhed ved subkutan administration af bortezomib versus intravenøs administration.
English: Bortezomib is highly selective for the proteasome.
Danish: Bortezomib er meget selektivt for proteasomet.
English: Also included are adverse drug reactions identified in the BR-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 BRCAP-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: 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 til progression, en signifikant længere overlevelse og en signifikant højere responsrate sammenlignet med behandling med dexametason (se tabel 14) hos alle patienter samt hos patienter, som tidligere havde fået én behandling.
English: Table 12: Efficacy results from study IFM-2005-01 Endpoints
Danish: Tabel 12: Effektresultater fra studiet IFM-2005-01 Effektmål
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, hypoæstesi, paræstesi, ubehag, neuropatiske smerter eller svækkelse.
English: Bortezomib should not be administered intrathecally.
Danish: Bortezomib må ikke administreres intratekalt.
English: (95% CI) (months)
Danish: (95 % CI) (måneder)
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Patient demographic and baseline disease characteristics were similar between the treatment groups.
Danish: Patientdemografiske og baseline-sygdomsegenskaber var sammenlignelige mellem behandlingsgrupperne.
English: Table 11: Efficacy results following the final survival update to VISTA study Efficacy endpoint
Danish: Tabel 11: Effektresultater efter den endelige opdatering af overlevelse i VISTA-studiet
English: Bortezomib therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL.
Danish: Behandling med bortezomib skal indstilles i op til 2 uger, indtil patienten har en ANC ≥ 750 celler/μl og et trombocyttal på ≥ 25.000 celler/μl.
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 blev også noteret en højere incidens af infektioner med grad ≥ 3 neutropeni (24 % versus 19 % i blok 1 og 22 % versus 11 % i blok 2), øget ALAT (17 % versus 8 % i blok 2), hypokalcæmi (18 % versus 6 % i blok 1 og 21 % versus 12 % i blok 2) og hyponatræmi (12 % versus 5 % i blok 1 og 4 % versus 0 i blok 2).
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: Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region d p-value for Response Rate (CR+PR) from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors e
Danish: Nominel p-værdi baseret på den stratificerede log-rank-test justeret for stratifikationsfaktorer: β2mikroglobulin, albumin og region d p-værdi for responsrate (CR+PR) fra Cochran-Mantel-Haenszel chi-square-test justeret for stratifikationsfaktorer e
English: Bortezomib may have a moderate influence on the ability to drive and use machines.
Danish: Bortezomib kan i moderat grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Danish: Den mediane gennemsnitsalder af patienterne i studiet var 57 år, 55 % var mænd, og 48 % af patienterne blev cytogenetisk klassificeret som højrisiko.
English: In addition to peripheral neuropathy, there may be a contribution of autonomic neuropathy to some adverse reactions such as postural hypotension and severe constipation with ileus.
Danish: Ud over perifer neuropati kan der yderligere forekomme autonom neuropati ved nogle bivirkninger så som postural hypotension og svær forstoppelse med ileus.
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: Matched-pair-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: 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 til behandlingen med bortezomib alene, få højdosis dexamethason sammen med bortezomib.
English: Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
Danish: Klinisk effekt ved subkutan administration af bortezomib hos patienter med recidiverende/refraktær myelomatose
English: Grade 2 with pain or grade 3 (severe symptoms; limiting self care ADL***)
Danish: Grad 2 med smerter eller Grad 3 (svære symptomer; begrænset personlige pleje; personlig ADL***)
English: Suicidal ideation*, Adjustment disorder, Delirium, Libido decreased
Danish: Selvmordstanker*, tilpasningsforstyrrelser, delirium, nedsat libido
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 en 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: Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone
Danish: Dosisjusteringer under behandling og efter re-initiering af kombinationsbehandling med melphalan og prednison
English: • Bruises, falls and injuries
Danish: • Blå mærker, fald og skader
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 af bortezomib og pegyleret liposomal doxorubicin.
English: g P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
Danish: P-værdi fra Cochran Mantel-Haenszel chi-square -test, med IPI og sygdomsstadie som stratifikationsfaktorer.
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: A statistically significant benefit (p < 0.001) in favour of the BR-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 BR-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: Macrophage activation
Danish: Aktivering af makrofager
English: - Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.
Danish: Når det er opløst, udtrækkes den relevante mængde af den rekonstituerede opløsning i henhold til beregnet dosis ud fra patientens legemsoverflade.
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: Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m 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/m hos patienter med myelomatose (n = 14 i den intravenøse gruppe, n = 17 i den subkutane gruppe) sås ækvivalente total systemisk eksponering efter gentagne doser (AUClast) for subkutan og intravenøs administration.
English: The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BR-CAP group and 5.0% in the R-CHOP group) as well as grade 3 and higher bleeding events (BR-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 BR-CAP-gruppen og 5,0 % i R-CHOP-gruppen) såvel som blødningshændelser af grad 3 og højere (BR-CAP: 4 patienter [1,7 %]; R-CHOP: 3 patienter [1,2 %]).
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-celler) i koncentrationer så lave som 3,125 μg/ml, som var den lavest undersøgte koncentration.
English: Haematological toxicity - ≥ Grade 3 neutropenia with fever, grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Danish: • ≥ Grad 3 neutropeni med feber, grad 4 neutropeni, som varer længere end 7 dage, trombocyttal < 10.000 celler/μl
English: Do not use bortezomib - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Danish: Brug ikke bortezomib - hvis du er allergisk over for bortezomib, bor eller et af de øvrige indholdsstoffer i denne medicin (angivet i afsnit 6).
English: Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Danish: Tabel 15: Resumé af effektanalyser sammenlignende subkutan og intravenøs administration af bortezomib
English: Based on animal studies, the penetration of bortezomib through the blood-brain barrier appears to be limited, if any and the relevance to humans is unknown.
Danish: Baseret på dyrestudier synes bortezomibs penetration af blod/hjerne-barrieren at være begrænset, om overhovedet nogen.
English: A lower starting dose is recommended in patients with moderate or severe hepatic impairment, and those patients should be closely monitored (see section 4.2, table 6).
Danish: Det anbefales at give en lavere startdosis til patienter med moderat eller alvorligt nedsat leverfunktion, og disse patienter bør monitoreres nøje (se pkt.
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 med bortezomib (som intravenøs injektion) viste ikke tegn på ortostatisk hypotension før behandlingen med bortezomib.
English: Inhibition of the proteasome results in cell cycle arrest and apoptosis.
Danish: Hæmning af proteasomet resulterer i cellecyklusstop og apoptose.
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Danish: Thalidomid er et kendt teratogent lægemiddel, som medfører livstruende medfødte misdannelser hos mennesker.
English: Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001)
Danish: Bortezomib-kombinationsbehandling med pegyleret liposomal doxorubicin (studie DOXIL-MMY
English: • Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood,
Danish: • Besvær eller problemer med at sove, svedeture, angst, humørsvingninger, nedsat humør,
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 dehydrerede pga. tilbagevendende diarré eller opkastning.
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 mikronukleus hos mus.
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 hjertesvigt og/eller ny forekomst af nedsat ejektionsfraktion fra venstre ventrikel ved behandling med bortezomib.
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 i højere grad i behandlingsregimet med bortezomib sammenlignet med et historisk kontrolstudie, hvor grundbehandlingen blev givet alene: i blok 1 perifer sensorisk neuropati (3 % versus 0 %); ileus (2,1 % versus 0 %), hypoxi (8 % versus 2 %).
English: White to off-white lyophilized powder or cake.
Danish: Hvid til offwhite frysetørret pulver eller masse.
English: In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to bortezomib were in the range 65-74 years and ≥ 75 years of age, respectively.
Danish: I et studie med patienter med tidligere ubehandlet mantlecellelymfom var henholdsvis 42,9 % og 10,4 % af de patienter, der fik bortezomib, i alderen 65-74 år og ≥ 75 år.
English: h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Danish: Inkluderer alle radiologiske CR+CRu+PR efter IRC uanset verificering ved knoglemarv og LDH.
English: Main efficacy results are presented in table 13.
Danish: De væsentligste effektresultater er præsenteret i tabel 13.
English: A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate
Danish: Der blev foretaget et farmakokinetisk studie hos patienter med varierende grad af nedsat nyrefunktion, som blev klassificeret i følgende grupper i henhold til deres kreatininclearance (CrCl): Normal (CrCl ≥ 60 ml/min/1,73 m2, n=12), Mild (CrCl=40-59 ml/min/1,73 m2, n=10), Moderat
English: Table 13: Efficacy results from study MMY-3010 Endpoints
Danish: Tabel 13: Effektresultater fra studie MMY-3010 Effektmål
English: Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
Danish: Estimatet af Hazard ratio er baseret på Cox' proportionelle risikomodel justeret for stratifikationsfaktorer: β2-mikroglobulin, albumin og region.
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 disease.
Danish: Demografiske og baseline-sygdomskarakteristika var generelt afbalanceret mellem de to behandlingsarme: Den mediane patientalder var 66 år, 74 % var mænd, 66 % var kaukasiere og 32 % asiatere, 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: An odds ratio (OR) > 1 indicates an advantage for BR-CAP.
Danish: En oddsratio (OR) > 1 angiver en fordel for BR-CAP.
English: Injection sites should be rotated for successive injections.
Danish: Der skal vælges et nyt injektionssted mellem på hinanden følgende injektioner.
English: For dose adjustments, see table 5 below.
Danish: Se tabel 5 nedenfor vedrørende dosisjusteringer.
English: Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each bortezomib 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.
English: This study included 222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m of bortezomib by either the subcutaneous or intravenous route for 8 cycles.
Danish: Dette studie inkluderede 222 patienter med recidiverende eller refraktær myelomatose, som blev randomiseret i forholdet 2:1 til at få 1,3 mg/m bortezomib enten som subkutan eller intravenøs administration i 8 cyklusser.