FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhibition of the 26S proteasome prevents this targeted proteolysis and affects multiple signalling cascades within the cell, ultimately resulting in cancer cell death.
Danish: Hæmning af 26S-proteasom forhindrer denne målrettede proteolyse og påvirker adskillige signaleringskaskader i cellen, hvilket i sidste ende resulterer i cancercelledød.
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were 80.18%-122.80%.
Danish: Den geometriske gennemsnitsratio AUClast var 0,99 og 90 % konfidensintervaller var 80,18 %-122,80
English: Treatment with bortezomib can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Danish: Behandlingen med bortezomib kan meget ofte forårsage et fald i antal af røde og hvide blodlegemer samt blodplader i blodet.
English: Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18%] in BDx group and 52/242 [21%] in VDDx group).
Danish: Henviser til responsrate efter den anden transplantation hos forsøgspersoner, der blev transplanteret 2 gange (42/240 [18 % ] i BDx-gruppen og 52/242 [21 %] i VDDx-gruppen).
English: Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Danish: Bortezomib-medieret proteasomhæmning påvirker cancerceller på flere måder, inklusive, men ikke begrænset til, ændring af regulerende proteiner, som styrer cellecyklusprogression, og aktiveringen af nuklear faktor kappa B (NF-κB).
English: The following information is intended for healthcare professionals only: Only the 3.5 mg vial can be administered subcutaneously, as described below.
Danish: Nedenstående oplysning er til læger og sundhedspersonale: Kun hætteglasset med 3,5 mg kan administreres subkutant som beskrevet nedenfor:
English: Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom
Danish: Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, Storbritannien
English: Bortezomib should not be used during pregnancy unless the clinical condition of the woman requires treatment with bortezomib.
Danish: Bortezomib bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med bortezomib.
English: Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Danish: Bortezomib blev kun administreret i blok 1 og 2 for at undgå potentielle overlappende toksiciteter med co-administrerede lægemidler i blok 3.
English: If bortezomib is used during pregnancy, or if the patient becomes pregnant while receiving this medicinal product, the patient should be informed of potential for hazard to the foetus.
Danish: Hvis bortezomib anvendes under graviditeten, eller hvis patienten bliver gravid, mens hun får dette lægemiddel, skal patienten orienteres om de mulige risici for fostret.
English: Consider dose escalation to 1.0 mg/m or further dose reduction to 0.5 mg/m in subsequent cycles based on patient tolerability.
Danish: Overvej dosisøgning til 1,0 mg/m eller yderligere dosisreduktion til 0,5 mg/m i efterfølgende cyklusser baseret på patientens tolerabilitet.
English: It is not known whether bortezomib is excreted in human milk.
Danish: Det er ukendt, hvorvidt bortezomib udskilles i human mælk.
English: 2 years
Danish: = måneder
English: It is recommended that patients with at least partial response receive 2 additional cycles.
Danish: Det anbefales, at patienter, der som minimum udviser partielt respons, modtager 2 yderligere cyklusser.
English: • bleeding problems and/or low number of platelets in your blood
Danish: • Blødningsproblemer og/eller lavt antal blodplader i blodet
English: Therefore, caution must be used during handling and preparation.
Danish: Derfor skal der udvises forsigtighed ved håndteringen og præparationen.
English: • heart or blood pressure problems
Danish: • Problemer med hjertet eller blodtrykket
English: Moreover, in dog studies, a slight increase in the corrected QT interval was observed.
Danish: Desuden blev der observeret en lille stigning i det korrigerede QT-interval i hundeforsøg.
English: Grade 1 (asymptomatic; loss of deep tendon reflexes or paresthesia) with no pain or loss of function
Danish: Grad 1 (asymptomatisk; tab af dybe senereflekser eller paræstesi) uden smerter eller funktionstab
English: Both men and women receiving bortezomib must use effective contraception during and for up to 3 months after treatment.
Danish: Både mænd og kvinder, som er i behandling med bortezomib, skal anvende sikker prævention under og i op til 3 måneder efter behandlingen.
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BR-CAP arm.
Danish: Antiviral profylakse blev administreret til 137 af 240 patienter (57 %) i BR-CAP-armen.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.>
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • need to handling the medicinal product in sterile setting
Danish: • At lægemidlet skal håndteres under sterile betingelser.
English: Median survival for the B+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Danish: Den mediane overlevelse i B+M+P-behandlingsgruppen var 56,4 måneder sammenlignet med 43,1 i M+P-behandlingsgruppen.
English: 9/l on a bortezomib dosing day (other than day 1)
Danish: 9/l på en bortezomib doseringsdag (bortset fra dag 1)
English: Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met.
Danish: Thalidomid er kontraindiceret under graviditet og til kvinder i den fertile alder, medmindre alle betingelserne i programmet for svangerskabsforebyggelse for thalidomid overholdes.
English: Antiviral prophylaxis was administered to 26% of the patients in the B+M+P arm.
Danish: Antiviral profylakse blev administreret til 26 % af patienterne i B+M+P-armen.
English: At 10 μM concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1,500-fold more selective for the proteasome than for its next preferable enzyme.
Danish: I koncentrationer på 10 μM hæmmer bortezomib ikke nogen af en lang række screenede receptorer og proteaser, og er mere end 1.500 gange mere selektivt for proteasomet end for det næste foretrukne enzym.
English: - Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).
Danish: Tjek dosis og koncentration i sprøjten før brug (kontroller, at sprøjten er mærket som intravenøs administration).
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 endelig pH-værdi på 4 til 7.
English: Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m per day)
Danish: Derfor frarådes det at anvende dette regime med samtidig administration af højdosis cytarabin (2 g/m daglig)
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m and included in table 7.
Danish: Disse bivirkninger er baseret på et integreret datasæt med 5.476 patienter, hvoraf 3.996 patienter blev behandlet med bortezomib ved 1,3 mg/m og er inkluderet i tabel 7.
English: Patients achieving a response or a stable disease after 4 cycles of this combination therapy can continue to receive the same combination for a maximum of 4 additional cycles.
Danish: Patienter, som opnår respons eller stabiliseret sygdom efter 4 cyklusser med denne kombinationsbehandling, kan fortsætte med den samme kombination i højst 4 yderligere cyklusser.
English: The ubiquitin-proteasome pathway plays an essential role in regulating the turnover of specific proteins, thereby maintaining homeostasis within cells.
Danish: Ubiquitin-proteasom-vejen spiller en vigtig rolle i reguleringen af omsætningen af specifikke proteiner, som derved opretholder homeostasen i cellerne.
English: Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types and that cancer cells are more sensitive to the pro-apoptotic effects of proteasome inhibition than normal cells.
Danish: Studier har vist, at bortezomib er cytotoksisk over for en række cancercelletyper, og at cancerceller er mere følsomme over for den pro-apoptotiske effekt af proteasomhæmning end normale celler.
English: • instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (bortezomib plus dexamethasone, and bortezomib plus dexamethasone and thalidomide).
Danish: • Instruktioner i ordinering og administration, herunder cyklussernes længde og antal cyklusser, for herved at minimere risikoen for lægmiddel- eller administrationsfejl, der kunne opstå grundet de to forskellige bortezomibkombinationsregimer i transplantationsinduktionsregi (bortezomib plus dexamethason og bortezomib plus dexamethason og thalidomid).
English: The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Danish: Det primære effektmål var TTP, og det sekundære effektmål var OS og ORR (CR+PR), ved brug af kriterierne fra The European Group for Blood and Marrow Transplantation (EBMT).
English: A hazard ratio < 1 indicates an advantage for BR-CAP.
Danish: En hazard ratio < 1 angiver en fordel for BR-CAP.
English: Patients with pre-existing severe neuropathy may be treated with bortezomib only after careful risk/benefit assessment.
Danish: Patienter med præ-eksisterende svær neuropati må kun behandles med bortezomib efter en omhyggelig vurdering af risici og fordele.
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 (f.eks. thalidomid), og passende dosisreduktion eller seponering af behandling skal overvejes.
English: tiredness, confusion, blindness or other vision problems.
Danish: træthed, konfusion, blindhed eller andre synsproblemer
English: It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells.
Danish: Den er specifikt designet til at hæmme chymotrypsin-lignende aktivitet ved 26S-proteasomet i pattedyrceller.
English: A statistically significant survival benefit in favour of the B+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Danish: Der blev observeret en statistisk signifikant forbedring af overlevelsen i B+M+P-behandlingsgruppen (HR=0,695; p=0,00043) til trods for efterfølgende behandlinger, inklusive regimer baseret på bortezomib.
English: • If prolonged grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
Danish: • Hvis der observeres langvarig grad 4 neutropeni eller trombocytopeni eller trombocytopeni med blødning i den forgående cyklus
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BR-CAP arm and with at least a possible or probable causal relationship to the components of the BR-CAP arm, are listed in table 8 below.
Danish: Bivirkninger, identificeret med en forekomst på ≥ 1 %, tilsvarende eller højere forekomst i BR-CAParmen og med mindst en mulig eller sandsynlig årsagssammenhæng med komponenterne i BR-CAParmen, er anført i tabel 8 nedenfor.
English: Uncommon Fall, Contusion Rare
Danish: Ikke almindelig Fald, kontusion Sjælden
English: No new safety concerns were observed when bortezomib was added to the standard pediatric pre B cell ALL chemotherapy backbone.
Danish: Der blev ikke observeret nogen nye sikkerhedsproblemer, når bortezomib blev adderet til den standard pædiatriske B-celle ALL kemoterapi grundbehandling.
English: PRES is a rare, often reversible, rapidly evolving neurological condition, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances.
Danish: PRES er en sjælden, ofte reversibel neurologisk lidelse, som udvikles hurtigt, og som kan optræde med blandt andet kramper, hypertension, hovedpine, sløvhed, forvirring, blindhed og andre visuelle og neurologiske forstyrrelser.
English: The kinetics of proteasome inhibition were evaluated in vitro, and bortezomib was shown to dissociate from the proteasome with a t½ of 20 minutes, thus demonstrating that proteasome inhibition by bortezomib is reversible.
Danish: Kinetikken ved proteasomhæmning blev vurderet in vitro, og det blev påvist, at bortezomib dissocierer fra proteasomet med en t½ på 20 minutter, hvilket viser, at proteasomhæmning ved hjælp af bortezomib er reversibel.
English: Grade ≥ 3 non-haematological toxicities
Danish: Grad ≥ 3 ikke-hæmatologiske toksiciteter
English: The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of bortezomib 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, forsynes med uddannelsespakken.
English: In non-clinical studies, bortezomib had no effects on embryonal/foetal development in rats and rabbits at the highest maternally tolerated doses.
Danish: I non-kliniske studier havde bortezomib ingen indvirkning på den embryonale/føtale udvikling hos rotter og kaniner ved den højest tålte dosis hos moderdyret.
English: • Increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine, fluid retention
Danish: • Øget eller nedsat urinproduktion (pga. nyreskade), smerter ved vandladning eller blod/protein i urinen, væskeophobning
English: Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m basis are associated with increases in heart rate, decreases in contractility, hypotension and death.
Danish: Farmakologiske studier vedrørende kardiovaskulær sikkerhed med aber og hunde viser, at intravenøse doser på ca. 2-3 gange den anbefalede kliniske dosis på mg/m2-basis er forbundet med pulsstigninger, fald i kontraktilitet, hypotension og dødsfald.
English: However, the dose-normalised mean AUC values were increased by approximately 60% in patients with moderate or severe hepatic impairment.
Danish: De gennemsnitlige AUC-værdier justeret i forhold til standarddosis forøgedes derimod med ca. 60 % hos patienter med moderat eller alvorligt nedsat leverfunktion.
English: Granulocyte colony stimulating factors may be administered for haematologic toxicity according to local standard practice.
Danish: Granulocytkolonistimulerende faktorer kan administreres ved hæmatologisk toksicitet i henhold til lokal standardpraksis.
English: a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 0.0001
Danish: Intent to Treat (ITT) population b p-værdi fra den stratificerede log-rank test; analyse ud fra behandling udelukker opdeling på tidligere behandling; p < 0,0001
English: • Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots
Danish: • Betændelse eller blødning i blodkarrene, der kan vise sig som små rødlige eller lilla prikker
English: How bortezomib is given
Danish: Hvordan bortezomib gives
English: The median number of cycles received for both groups was 4 cycles.
Danish: Begge grupper fik i gennemsnitlig 4 cyklusser.
English: Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Danish: Sekundære effektmål omfattede post-transplantations-responsrater (CR+nCR, CR+nCR+VGPR+PR), progressionsfri overlevelse og samlet overlevelse.
English: Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA).
Danish: Baseret på en farmakokinetisk populationsanalyse øgedes bortezomibclearance ved stigende legemsoverfladeareal (BSA).
English: Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function.
Danish: Resultater fra in vitro, ex-vivo og dyremodeller med bortezomib tyder på, at bortezomib øger osteoblast-differentieringen og -aktiviteten og hæmmer osteoklastfunktionen.
English: Grade ≥ 3 non-haematological toxicities considered to be related to bortezomib
Danish: Grad ≥ 3 ikke-hæmatologisk toksicitet, som anses for at være relateret til bortezomib
English: Therefore, caution should be used during handling and preparation of bortezomib.
Danish: Der skal derfor udvises forsigtighed ved håndtering og anvendelse af bortezomib.
English: Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with bortezomib.
Danish: Fase II-studiet MMY-2036 (RETRIEVE), et open-label studie med en enkelt arm, blev udført for at bestemme effekt og sikkerhed af genbehandling med bortezomib.
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Danish: Yderligere bivirkninger, som blev identificeret i forbindelse med brug af kombinationsbehandling (BR-CAP), var hepatitis B-infektion (< 1 %) og myokardie-iskæmi (1,3 %).
English: Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Danish: Sekundære effektmål inkluderede tid til progression (TTP), tid til næste antilymfombehandling (TNT), varighed af behandlingsfrit interval (TFI), samlet responsrate (ORR) og komplet respons (CR/CRu)-rate, samlet overlevelse (OS) og responsvarighed.
English: Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
Danish: På baggrund af det begrænsede bidrag (7 %) fra CYP2D6 til metaboliseringen af bortezomib, forventes det ikke, at CYP2D6-fænotypen, som metaboliserer dårligt, påvirker den samlede disponering for bortezomib.
English: • The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Danish: Den rekonstituerede opløsning administreres subkutant i låret (højre eller venstre) eller abdomen (højre eller venstre side).
English: If you are given too much bortezomib
Danish: Hvis du har brugt for meget bortezomib
English: If you have mantle cell lymphoma and are given the medicine rituximab with bortezomib you must tell your doctor:
Danish: Hvis du har mantle-celle-lymfom og får lægemidlet rituximab sammen med bortezomib, skal du fortælle det til din læge:
English: Patients should be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML as part of the differential diagnosis of CNS problems.
Danish: Patienterne bør monitoreres regelmæssigt for nye eller tiltagende neurologiske symptomer eller tegn, der kunne tyde på PML, som led i differentialdiagnosticeringen af lidelser i centralnervesystemet.
English: As a result of a pre-planned interim analysis, the dexamethasone arm was halted at the recommendation of the data monitoring committee and all patients randomised to dexamethasone were then offered bortezomib, regardless of disease status.
Danish: Som et resultat af den forud planlagte interimanalyse blev dexametason-armen standset på anbefaling fra datamonitoreringskomitéen og fik derefter tilbudt bortezomib uanset sygdommens status.
English: Patients in the BTDx 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 BTDx- 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: 42.9% and 10.4% of patients in the BR-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 BR-CAP-armen var i alderen 65-74 år og ≥ 75 år.
English: The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80.
Danish: Den mediane alder hos patienterne i studiet var 71 år, 50 % var mænd, 88 % var kaukasiere og medianen for Karnofsky performance status for patienterne var en score på 80.
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: Refererer til madlavning, indkøb af dagligvarer eller tøj, brug af telefon, håndtering af penge osv. *** Personlig ADL: Refererer til bad, på-/afklædning, spisning, toiletbesøg, tage medicin og oppegående
English: CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Danish: CR = fuldstændigt respons; nCR = næsten fuldstændigt respons PR = partielt respons; MR = minimalt respons
English: Undesirable effects in table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Danish: Bivirkningerne i tabel 7 ansås af investigatorerne for mindst at have en mulig eller sandsynlig årsagsmæssig sammenhæng med bortezomib.
English: Refer to the Summary of Product Characteristics of thalidomide for additional information.
Danish: Der henvises til produktresuméet for thalidomid for yderligere information.
English: Over a bortezomib concentration range of 0.01 to 1.0 μg/ml, the in vitro protein binding averaged 82.9% in human plasma.
Danish: I koncentrationsinterval for bortezomib på 0,01-1,0 μg/ml var in vitro proteinbindingen gennemsnitligt 82,9 % i humant plasma.
English: The majority of the patients in both groups completed treatment, 80% in the BR-CAP group and 82% in the R-CHOP group.
Danish: Størstedelen af patienterne i begge grupper fuldførte behandlingen, 80 % i BR-CAP-gruppen og 82 % i R-CHOP-gruppen.