FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the dose-normalised mean AUC values were increased by approximately 60% in patients with moderate or severe hepatic impairment.
Danish: De gennemsnitlige, dosis-normaliserede AUC-værdier steg imidlertid med cirka 60% hos patienter med moderat eller alvorligt nedsat leverfunktion.
English: When bortezomib is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Danish: Hvis bortezomib gives sammen med thalidomid og dexamethason, er varigheden af en behandlingscyklus 28 dage (4 uger).
English: Exposure of bortezomib (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Danish: Eksponeringen for bortezomib (dosis-normaliseret AUC og Cmax) var sammenlignelig for alle grupper (se pkt.
English: • Reduction in the number of red blood cells and or white blood cells (see above)
Danish: • Fald i antallet af røde blodlegemer eller hvide blodlegemer (se ovenfor)
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-gruppen.
English: Rare side effects (may affect up to 1 in 1,000 people) Blood clot in small blood vessels (thrombotic microangiopathy)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter) • Blodprop i små blodkar (thrombotisk mikroangiopati)
English: Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8).
Danish: Patienterne skal derfor være forsigtige, når de fører motorkøretøj eller betjener maskiner, og skal frarådes at føre motorkøretøj eller betjene maskiner, hvis de oplever disse symptomer (se pkt.
English: NF-kB is a transcription factor whose activation is required for many aspects of tumourigenesis, including cell growth and survival, angiogenesis, cell-cell interactions, and metastasis.
Danish: NFκB er en transkriptionsfaktor, hvis aktivering kræves til mange aspekter af tumorgenesen, herunder cellevækst og -overlevelse, angiogenese, celle-celle-interaktioner og metastase.
English: A hazard ratio < 1 indicates an advantage for BR-CAP.
Danish: En hazard ratio på < 1 angiver en fordel for BR-CAP.
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 effektendepunkt var TTP, mens det sekundære effektendepunkt var OS og ORR (CR+PR), hvor kriterierne fra The European Group for Blood and Marrow Transplantation (EBMT) blev brugt.
English: • carbamazepine, phenytoin or phenobarbital used to treat epilepsy
Danish: • carbamazepin, phenytoin eller phenobarbital, der bruges til behandling af epilepsi
English: If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of Bortezomib Hospira must be considered unless the benefit of treatment clearly outweighs the risk.
Danish: Hvis toksiciteten ikke forsvinder, eller hvis den opstår igen ved den laveste dosis, skal seponering af Bortezomib Hospira overvejes, medmindre fordelene ved behandlingen tydeligt opvejer risiciene.
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: Forsøg har vist, at bortezomib er cytotoksisk over for en række cancercelletyper, og at cancerceller er mere følsomme over for de pro-apoptotiske virkninger af proteasomhæmningen end normale celler.
English: • heart or blood pressure problems
Danish: • problemer med hjerte eller blodtryk
English: In the BTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Danish: I BTDx-gruppen var 12% af patienterne cytogenetisk klassificeret som højrisiko vs. 16% af patienterne i TDx-gruppen.
English: b 57 (45)
Danish: (38)b b 57 (45)
English: Time related events n=333
Danish: Tidsrelaterede hændelser n=333
English: Grade 1 (asymptomatic; loss of deep tendon reflexes or paraesthesia) with no pain or loss of function
Danish: Grad 1 (asymptomatisk; tab af dybe senereflekser eller paræstesi) uden smerter eller funktionstab
English: Best response n=315
Danish: Bedste respons n=315
English: * Grouping of more than one MedDRA preferred term.
Danish: * Gruppering af mere end én foretrukken term iht.
English: An odds ratio (OR) > 1 indicates an advantage for BR-CAP.
Danish: En odds ratio (OR) på > 1 angiver en fordel for BR-CAP.
English: B= bortezomib M=melphalan, P=prednisone
Danish: B= bortezomib M=melphalan, P=prednison
English: BSA-normalized clearance of bortezomib in paediatric patients was similar to that observed in adults.
Danish: Bortezomibs BSA-normaliserede clearance hos pædiatriske patienter er den samme som den, der ses hos voksne.
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-proteasomet forhindrer denne målrettede proteolyse og påvirker flere signaleringskaskader inde i cellen, hvilket til sidst fører til, at cancercellerne dør.
English: There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mantle cell lymphoma.
Danish: Der findes ingen evidens for, at dosisjustering er nødvendig hos patienter over 65 år med myelomatose eller mantle-celle-lymfom.
English: A minority of patients with orthostatic hypotension experienced syncopal events.
Danish: En lille gruppe patienter med ortostatisk hypotension havde hændelser med synkope.
English: The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Bortezomib Hospira is provided with educational material.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alt sundhedspersonale, der er involveret i ordination, udlevering, håndtering eller administration af Bortezomib Hospira, får udleveret uddannelsesmaterialet.
English: May be fatal if given by other routes
Danish: Kan være fatalt ved anvendelse af andre administrationsveje
English: • If several Bortezomib Hospira doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Danish: • Hvis flere doser Bortezomib Hospira i en cyklus afbrydes (≥ 3 doser ved administration 2 gange om ugen eller ≥ 2 doser ved administration én gang om ugen)
English: Name and address of the manufacturers responsible for batch release Hospira UK Ltd.
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Hospira UK Ltd.
English: the combined 1-year survival rate was 88.1%.
Danish: Den kombinerede overlevelse efter 1 år var for disse dosiskohorter 88,1%.
English: The similar incidences of these events in both treatment arms, indicated that these adverse drug reactions are not attributable to bortezomib alone.
Danish: Den ensartede forekomst af disse hændelser i begge behandlingsgrupper tyder på, at disse bivirkninger ikke kan tilskrives bortezomib alene.
English: For patients with a response first documented at cycle 6, two additional treatment cycles were given.
Danish: Til patienter med et respons, som først blev dokumenteret ved cyklus 6, blev der givet 2 supplerende behandlingscyklusser.
English: • Blood clot in small blood vessels (thrombotic microangiopathy)
Danish: • Blodprop i små blodkar (thrombotisk mikroangiopati)
English: Platelet transfusion for the treatment of thrombocytopenia should be considered when clinically appropriate.
Danish: Thrombocyttransfusion til behandling af thrombocytopeni skal overvejes, når det er klinisk relevant.
English: The teratogenic potential of bortezomib has not been fully investigated.
Danish: Bortezomibs teratogene potentiale er ikke fuldstændigt undersøgt.
English: Autonomic neuropathy may be related to bortezomib or bortezomib may aggravate an underlying condition such as diabetic or amyloidotic neuropathy.
Danish: Autonom neuropati kan være forbundet med bortezomib, eller bortezomib kan forværre en tilgrundliggende tilstand såsom diabetisk eller amyloid neuropati.
English: 39 ml/min/1.73 m 2, n=9), and Severe (CrCL < 20 ml/min/1.73 m 2, n=3).
Danish: ml/min/1,73 m 2, n=9) og alvorlig (CrCl < 20 ml/min/1,73 m 2, n=3).
English: It is recommended that patients with at least partial response receive 2 additional cycles.
Danish: Det anbefales, at patienter, der som et minimum opnår partielt respons, får 2 ekstra cyklusser.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis produktet ikke anvendes straks, er opbevaringstid og -betingelser inden anvendelse brugerens eget ansvar.
English: In the event of new or worsening pulmonary symptoms (e.g., cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients treated appropriately.
Danish: I tilfælde af nye lungesymptomer eller forværring af lungesymptomer (f.eks. hoste, dyspnø) er det nødvendigt med en hurtig diagnosticering, og at patienterne behandles i overensstemmelse hermed.
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 inde i cellerne.
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-gruppen.
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, der opnår respons eller stabiliseret sygdom efter 4 cyklusser med denne kombinationsbehandling, kan fortsætte med den samme kombination i højst 4 cyklusser yderligere.
English: Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered medicinal product in Block 3.
Danish: Bortezomib blev kun administreret i blok 1 og 2 for at undgå potentiel overlapning af toksiciteter med samtidigt administrerede lægemidler i blok 3.
English: There have been isolated cases of QT-interval prolongation in clinical studies, causality has not been established.
Danish: Der har været enkeltstående tilfælde af forlængelse af QT-intervallet i kliniske forsøg; den kausale sammenhæng er ikke fastlagt.
English: It is recommended that patients receive 2 cycles of Bortezomib Hospira following a confirmation of a complete response.
Danish: Det anbefales, at patienterne får 2 cyklusser med Bortezomib Hospira efter bekræftelse af komplet respons.
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 (på grund af nyreskade), smerter ved vandladning eller blod/protein i urinen, væskeophobning
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: Medianoverlevelsen i B+M+Pbehandlingsgruppen var 56,4 måneder sammenlignet med 43,1 i M+P-behandlingsgruppen.
English: Musculoskeletal pain*
Danish: Muskuloskeletale smerter*
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 dexamethason-gruppen standset på anbefaling fra datamonitoreringskomiteen, og alle patienter fik derefter tilbudt bortezomib uanset sygdomsstatus.
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 så selektivt for proteasomet som for dets næste foretrukne enzym.
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 til ordination og administration, herunder cyklussernes længde og antal cyklusser, for herved at minimere risikoen for medicinerings- eller administrationsfejl, der kan opstå som følge af de to forskellige kombinationsregimer med bortezomib i transplantationsinduktionsregi (bortezomib plus dexamethason og bortezomib plus dexamethason og thalidomid)
English: Carriers of hepatitis B and patients with a history of hepatitis B must be closely monitored for clinical and laboratory signs of active HBV infection during and following rituximab combination treatment with Bortezomib Hospira.
Danish: Bærere af hepatitis B og patienter med en anamnese med hepatitis B skal monitoreres nøje for kliniske og laboratoriemæssige tegn på aktiv HBV-infektion under og efter rituximab-kombinationsbehandling med Bortezomib Hospira.
English: • Confirm the dose and concentration in thesyringe prior to use.
Danish: • Kontrollér dosis og koncentrationen i sprøjten inden anvendelse.
English: (Check that the syringe is markedas subcutaneous administration.)
Danish: (Kontrollér, at sprøjten er mærket til subkutan administration).
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, herunder regimer baseret på bortezomib.
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: Data fra forsøg in vitro, ex vivo og i dyremodeller med bortezomib tyder på, at bortezomib øger osteoblastdifferentieringen og -aktiviteten og hæmmer osteoklastfunktionen.
English: The median number of cycles received for both groups was 4 cycles.
Danish: Begge grupper fik et medianantal cyklusser på 4.
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 kramper, hypertension, hovedpine, letargi, konfusion, blindhed og andre visuelle og neurologiske forstyrrelser.
English: Concomitant medicinal products
Danish: Samtidige medicineringer
English: Patients on oral antidiabetic agents receiving Bortezomib Hospira treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
Danish: Patienter i behandling med orale antidiabetika, som behandles med Bortezomib Hospira, kan have brug for nøje monitorering af deres blodsukkerniveau og justering af deres antidiabetika-dosis.
English: Pregnancy and breast-feeding You should not use bortezomib if you are pregnant, unless clearly necessary.
Danish: Graviditet og amning Du må ikke bruge Bortezomib Hospira, hvis du er gravid, medmindre det er absolut nødvendigt.
English: Female patients of childbearing potential and male patients must use effective contraceptive measures during and for 3 months following treatment.
Danish: Kvindelige patienter i den fertile alder og mandlige patienter skal anvende sikker kontraception under behandlingen og i 3 måneder efter behandlingen.
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: Både hos de patienter, 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: No information on possible sequelae or rates of peripheral neuropathy resolution were available in this study.
Danish: Der var ingen tilgængelige oplysninger om mulige sequelae eller raterne for helbredelse af perifer neuropati i dette forsøg.
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), er hepatitis B-infektion (< 1%) og myokardie-iskæmi (1,3%).
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 prækliniske forsøg havde bortezomib ingen virkning på den embryonale/føtale udvikling hos rotter og kaniner ved den højeste maternelt tålte dosis.
English: All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively.
Danish: Perifer neuropati uanset grad og perifer neuropati ≥ grad 3 blev set hos henholdsvis 40% og 8,5% af patienterne.
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 undersøgt in vitro, og det blev påvist, at bortezomib adskiller sig fra proteasomet med et t½ på 20 minutter, hvilket viser, at bortezomibs proteasomhæmning er reversibel.
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 produktet er opløst, udtrækkes den ønskede mængde af den rekonstituerede opløsning i henhold til den dosis, der er beregnet ud fra patientens legemsoverfladeareal.
English: Very Common Pneumonia* Common
Danish: Meget almindelig Pneumoni* Almindelig
English: • Infection of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis)
Danish: • Infektion i øjets yderste lag og på indersiden af øjenlåget (konjunktivitis)
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: Inden for bortezomibs koncentrationsinterval på 0,01-1,0 µg/ml er proteinbindingen in vitro gennemsnitligt 82,9% i humant plasma.
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 Hospira, skal bruge sikker prævention under og op til 3 måneder efter behandlingen.
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: ** Instrumental ADL: dækker madlavning, indkøb af dagligvarer eller tøj, brug af telefon, håndtering af penge osv. *** ADL med personlig pleje: dækker badning, på- og afklædning, spisning, toiletbesøg, indtagelse af medicin og oppegående.
English: Herpes zoster virus reactivation
Danish: Reaktivering af herpes zoster-virus
English: Early and regular monitoring for symptoms of treatment-emergent neuropathy with neurological evaluation should be considered in patients receiving Bortezomib Hospira 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 Hospira i kombination med lægemidler, der vides at være forbundet med neuropati (f.eks. thalidomid), og passende dosisreduktion eller behandlingsseponering skal overvejes.
English: Table 12: Efficacy results from study IFM-2005-01 Endpoints
Danish: Tabel 12: Effektresultater fra forsøg IFM-2005-01 Endepunkter
English: • Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
Danish: • Injicér opløsningen som en 3-5 sekunders intravenøs injektion gennem et perifert eller centralt intravenøst kateter ind i en vene.
English: in BDx group and 52/242 [21%] in VDDx group).
Danish: (42/240 [18% ] i BDx-gruppen og 52/242 [21%] i VDDx-gruppen).
English: If Bortezomib Hospira 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 Hospira anvendes under graviditeten, eller hvis patienten bliver gravid, mens hun får dette lægemiddel, skal hun orienteres om de mulige risici for fostret.
English: Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Danish: Overvej dosisøgning til 1,0 mg/m2 eller yderligere dosisreduktion til 0,5 mg/m2 i de efterfølgende cyklusser, afhængigt af patientens tolerabilitet.
English: Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA).
Danish: Baseret på en farmakokinetisk populationsanalyse steg bortezomibs clearance i takt med et stigende BSA (legemsoverfladeareal).
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/m2 and included in Table 7.
Danish: Disse bivirkninger er baseret på et integreret datasæt med 5.476 patienter, hvoraf 3.996 blev behandlet med bortezomib i en dosis på 1,3 mg/m2, og er inkluderet i tabel 7.
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: De sekundære effektendepunkter omfattede tid indtil progression (TTP), tid indtil næste anti-lymfombehandling (TNT), varighed af behandlingsfrit interval (TFI), samlet responsrate (ORR) og komplet responsrate (CR/CRu), samlet overlevelse (OS) og responsvarighed.
English: • ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Danish: • Neutropeni ≥ grad 3 med feber, neutropeni grad 4 i mere end 7 dage, thrombocyttal < 10.000 celler/μl
English: Intent to Treat Population n=74
Danish: Intention to treat-population n=74
English: 222 subjects were enrolled into the study; 221 subjects were treated with bortezomib Hazards ratio estimate is based on a Cox model adjusted for stratification factors: ISS staging and number of prior lines.
Danish: Der indgik 222 forsøgspersoner i forsøget, og 221 af disse blev behandlet med bortezomib Estimatet af hazards ratio er baseret på en Cox-model justeret for stratifikationsfaktorer: ISSstadieinddeling og antal tidligere linjer d.
English: Patients with pre-existing severe neuropathy may be treated with Bortezomib Hospira only after careful risk/benefit assessment.
Danish: Patienter med eksisterende svær neuropati må kun behandles med Bortezomib Hospira efter en nøje vurdering af risici og fordele.