FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you think you have hepatitis infection now or have had it in the past.
Danish: • hvis du tror, du har hepatitis-infektion nu, eller hvis du har haft det engang.
English: White to off-white cake or powder.
Danish: Hvid til offwhite kage eller pulver.
English: Based on Independent Review Committee (IRC) assessment (radiological data only).
Danish: Baseret på bedømmelse fra en uafhængig review-komité (IRC) (kun radiologiske data).
English: Consider reduction of the melphalan dose by 25% in the next cycle.
Danish: Overvej reduktion af melphalan dosis med 25 % i den næste cyklus.
English: • Disorders that affect your lungs, preventing your body from getting enough oxygen.
Danish: • Sygdomme, der påvirker lungerne og forhindrer kroppen i at få nok ilt.
English: This survival was greater than the six-to-nine month median survival anticipated by consultant clinical investigators for a similar patient population.
Danish: Denne overlevelse var større end den mediane 6-9 måneders overlevelse, der blev forventet af rådgivende kliniske investigatorer for en lignende patientpopulation.
English: TTP, days [95% CI] 1 year survival,
Danish: TTP, dage [95 % CI] 1 års overlevelse,
English: • Diarrhoea: if this happens, it is important that you drink more water than usual.
Danish: Hvis du har diaré, er det vigtigt, at du drikker mere vand, end du plejer.
English: Eighteen percent of patients achieved, or had an improved response [MR (11%) or PR (7%)] with combination treatment.
Danish: 18 % af patienterne nåede eller havde en forbedret respons [MR (11 %) eller PR (7 %)] med kombinationsbehandlingen.
English: • Difficulty or problems in sleeping
Danish: • Besvær eller problemer med at sove
English: Response parameters as well as TTP remained significantly better for VELCADE independently of age.
Danish: Responsparametre samt TTP forblev signifikant bedre for VELCADE uafhængig af alder.
English: Your doctor may give you another medicine to control diarrhoea
Danish: Lægen kan give dig medicin til at kontrollere diaréen med
English: Most cases of PML were diagnosed within 12 months of their first dose of VELCADE.
Danish: De fleste tilfælde af PML blev diagnosticeret inden for 12 måneder efter første dosis VELCADE.
English: Potentially immunocomplex-mediated reactions
Danish: Mulige immunkompleksmedierede reaktioner
English: A group of dialysis patients who were dosed after dialysis was also included in the study (n=8).
Danish: En gruppe dialysepatienter, som fik VELCADE efter dialyse, blev også inkluderet i studiet (n = 8).
English: • Constipation with or without bloating (can be severe)
Danish: • Forstoppelse med eller uden oppustethed (kan være alvorlig)
English: Use of gloves and other protective clothing to prevent skin contact is recommended.
Danish: Anvendelse af handsker og anden beskyttelsespåklædning til at beskytte mod kontakt med huden anbefales.
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the VcDx group.
Danish: Den gennemsnitlige behandlingsvarighed var 13 uger for VDDx-gruppen og 11 uger for VcDx-gruppen.
English: Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies
Danish: Tabel 14: Resume over sygdomsresultater fra fase III- (APEX) og fase II-studier
English: ● Additional risk minimisation measures
Danish: • Yderligere risikominimeringsforanstaltninger
English: VELCADE should not be used in children and adolescents because it is not known how the medicine will affect them.
Danish: Børn og unge VELCADE bør ikke bruges til børn og unge, da det ikke vides, hvordan lægemidlet vil påvirke dem.
English: In the refractory population of the Phase II study, responses were determined by an independent review committee and the response criteria were those of the European Bone Marrow Transplant Group.
Danish: I den refraktære population i fase II-studiet blev responsen fastlagt af en uafhængig review-komite, og responskriterierne fra The European Bone Marrow Transplant Group blev brugt.
English: • Inability to produce enough insulin or resistance to normal levels of insulin
Danish: • Manglende evne til at danne tilstrækkeligt insulin eller resistens mod normale insulinniveauer
English: No new safety concerns were observed during the study, and in particular VELCADE did not exacerbate target organ damage (heart, kidney and liver).
Danish: Der blev ikke observeret nye sikkerhedssproblemer i løbet af studiet, og navnlig medførte VELCADE ikke forværring af skader på målorganer (hjerte, nyrer og lever).
English: The observed final median difference in the OS between the 2 treatment groups was 35 months.
Danish: Den observerede endelige mediane forskel i OS mellem de to behandlingsgrupper var 35 måneder.
English: The final analysis for OS was performed after a median follow-up of 82 months.
Danish: Den endelige analyse af OS blev udført efter en median opfølgning på 82 måneder.
English: Based on Kaplan-Meier product limit estimates.
Danish: Baseret på Kaplan-Meier-estimater for produktgrænser.
English: Reduction in serum M-protein population g n=667
Danish: Reduktion i serum M-protein population g n = 667
English: • Abnormal reaction to blood transfusions
Danish: • Unormal reaktion på blodtransfusioner
English: Electrocardiogram investigations
Danish: Elektrokardiogram undersøgelser
English: In the 6-month rat study, degenerative effects in both the testes and the ovary have been observed.
Danish: I studier med 6-måneders rotter, sås degenerative virkninger på både testikler og ovarier.
English: Date of first authorisation: 26 April 2004 Date of latest renewal: 10 January 2014
Danish: Dato for første markedsføringstilladelse: 26. april 2004 Dato for seneste fornyelse: 10. januar 2014
English: • Sensitivity to light
Danish: • Følsomhed over for lys
English: VELCADE should not be used during pregnancy unless the clinical condition of the woman requires treatment with VELCADE.
Danish: VELCADE bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med VELCADE.
English: The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to VELCADE alone.
Danish: Protokollen tillod, at patienterne fik dexamethason, hvis de havde haft en mindre end optimal respons på VELCADE alene.
English: Dissolution of the lyophilised powder is completed in less than 2 minutes.
Danish: Opløsning af det frysetørrede pulver sker på mindre end 2 minutter.
English: Median duration of follow up is 11.8 months
Danish: Median varighed af opfølgning er 11,8 måneder
English: In addition, secondary response-related and time to event related efficacy endpoints showed consistent results for subcutaneous and intravenous administration (Table 15).
Danish: Desuden viste de sekundære endepunkt, som var relateret til respons og tid til hændelse, overensstemmende resultater for subkutan og intravenøs administration (tabel 15).
English: Treatment with VELCADE can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Danish: Behandlingen med VELCADE kan meget ofte forårsage et fald i antal af røde og hvide blodlegemer samt blodplader i blodet.
English: You do not need to check the pH of the solution.
Danish: Man behøver ikke at tjekke pH-værdien af opløsningen.
English: VELCADE was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Danish: VELCADE blev kun administreret i blok 1 og 2 for at undgå potentiel overlappende toksicitet med co-administrerede lægemidler i blok 3.
English: Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
Danish: Responspopulation omfatter patienter, som havde målbar sygdom ved baseline og fik mindst 1 dosis studiemedicin.
English: By multivariate analysis, the response rate was independent of myeloma type, performance status, chromosome 13 deletion status, or the number or type of previous therapies.
Danish: Ved multivarians analyse var responsraten uafhængig af myelomtype, performance status, kromosom 13 deletion-status og antallet eller typen af tidligere behandling.
English: • Hormone abnormality which may affect salt and water absorption
Danish: • Hormonelle uregelmæssigheder, som kan påvirke salt- og vandoptagelsen
English: Vc=VELCADE; Dx=dexamethasone; T=thalidomide
Danish: Vc = VELCADE; Dx = dexamethason; T = thalidomid
English: When VELCADE is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Danish: Når VELCADE gives sammen med thalidomid og dexamethason, er varigheden af en behandlingscyklus 28 dage (4 uger).
English: • Inability to tolerate alcohol consumption
Danish: • Kan ikke tåle at drikke alkohol
English: Your doctor will work out your dose of VELCADE 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: • low numbers of red or white blood cells
Danish: • lavt antal røde eller hvide blodlegemer
English: A vial is for single use only and the remaining solution must be discarded.
Danish: Et hætteglas er kun til engangsbrug og resterende opløsning skal bortskaffes.
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 gennemtrængningen af bortezomib gennem blod/hjerne-barrieren at være begrænset, om overhovedet nogen og relevansen for mennesker er ukendt.
English: • Infection of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis)
Danish: • Infektion i øjets yderste lag og i indersiden af øjenlåget (conjunctivitis)
English: • Increase of platelets or plasma cells (a type of white cell) in the blood
Danish: • Øget antal blodplader eller plasmaceller (en type hvide celler) i blodet
English: • Altered level of consciousness, confusion
Danish: • Ændret bevidsthedsniveau, forvirring
English: Most patients required treatment for their orthostatic hypotension.
Danish: De fleste patienter havde brug for behandling mod ortostatiske hypotension.
English: OR; 95% CI; P value
Danish: OR; 95 % CI; P værdi
English: In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Danish: I de enkelte medlemslande skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om format og indhold af uddannelsespakken.
English: • If several VELCADE doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Danish: • Hvis flere VELCADE-doser i en cyklus tilbageholdes (≥ 3 doser under indgift to gange om ugen eller ≥ 2 doser under indgift en gang om ugen)
English: At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered Vc+M+P treatment.
Danish: På tidspunktet for en forudspecificeret interimanalyse var det primære endepunkt, tid til progression, opnået, og patienterne i M+P-gruppen blev tilbudt Vc+M+P-behandling.
English: VELCADE is for single use only.
Danish: VELCADE er kun til engangsbrug.
English: Pregnancy and breast-feeding You should not use VELCADE if you are pregnant, unless clearly necessary.
Danish: Graviditet og amning Du må ikke bruge VELCADE hvis du er gravid, medmindre det er absolut nødvendigt.
English: • Death
Danish: • Død
English: The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Danish: Det primære effektendepunkt var progressionsfri overlevelse baseret på en bedømmelse fra en uafhængig review-komité (IRC).
English: BSA-normalized clearance of bortezomib in pediatric patients was similar to that observed in adults.
Danish: BSAnormaliseret bortezomib-clearance hos pædiatriske patienter var den samme som den, der observeres hos voksne.
English: VELCADE should not be administered intrathecally.
Danish: VELCADE må ikke administreres intratekalt.
English: If you have a history of hepatitis B infection you will be carefully checked by your doctor for signs of active hepatitis B.
Danish: Hvis du tidligere har haft hepatitis B-infektion, vil din læge undersøge dig omhyggeligt for at se, om du har tegn på aktiv hepatitis B.
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 (trombotisk mikroangiopati)
English: Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Danish: Op til 6 cyklusser kan gives til patienter, der får i det mindste partielt respons efter 4 cyklusser
English: Exposure of VELCADE (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Danish: Eksponering for VELCADE (dosis-normaliseret AUC og Cmax) var sammenlignelig for alle grupper (se pkt.
English: How VELCADE is given
Danish: Hvordan VELCADE gives
English: Elderly MCL patients
Danish: Ældre patienter med MCL
English: If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of VELCADE must be considered unless the benefit of treatment clearly outweighs the risk.
Danish: Hvis toksiciteten ikke forsvinder, eller hvis den forekommer igen ved den laveste dosis, skal seponering af VELCADE overvejes, medmindre fordelene ved behandlingen tydeligt opvejer risici.
English: Vc=VELCADE; M=melphalan, P=prednisone
Danish: Vc = VELCADE; M = melphalan, P = prednison
English: • moderate to severe liver problems
Danish: • moderate til svære problemer med leveren
English: In the VcTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Danish: I VcTDx-gruppen var 12 % af patienterne cytogenetisk klassificeret som højrisiko versus 16 % af patienterne i TDx-gruppen.
English: VELCADE may have a moderate influence on the ability to drive and use machines.
Danish: VELCADE påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: CI=Confidence Interval
Danish: CI = konfidensinterval
English: Six percent of patients had an adverse local reaction to subcutaneous administration, mostly redness.
Danish: Seks procent af patienterne fik en lokal reaktion på subkutan administration, for det meste rødmen.
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Frekvensen defineres som: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If VELCADE 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 VELCADE anvendes under graviditeten, eller hvis patienten bliver gravid, mens hun får dette lægemiddel, skal hun orienteres om de mulige risici for fostret.
English: (CrCL=20-39 ml/min/1.73 m 2, n=9), and Severe (CrCL < 20 ml/min/1.73 m 2, n=3).
Danish: (CrCl = 20-39 ml/min/1,73 m 2, n = 9) og Alvorlig (CrCl < 20 ml/min/1,73 m 2, n = 3).
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the VcR-CAP arm and with at least a possible or probable causal relationship to the components of the VcR-CAP arm, are listed in Table 8 below.
Danish: Lægemiddelbivirkninger, identificeret med en forekomst på ≥ 1 %, tilsvarende eller højere forekomst i VcR-CAP-armen og med mindst en mulig eller sandsynlig årsagssammenhæng med komponenterne i VcR-CAP-armen, er anført i tabel 8 nedenfor.
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 multiple signalleringskaskader i cellen, hvilket til sidst resulterer i cancer-celle-død.
English: Patients with pre-existing severe neuropathy may be treated with VELCADE only after careful risk/benefit assessment.
Danish: Patienter med præ-eksisterende, svær neuropati må kun behandles med VELCADE efter en omhyggelig vurdering af risici og fordele.
English: If you are given too much VELCADE
Danish: Hvis du har brugt for meget VELCADE
English: • Reduction in the number of red blood cells and or white blood cells (see above)
Danish: • Reduktion i antallet af røde blodlegemer eller hvide blodlegemer (se ovenfor)
English: Haematological toxicity during a cycle
Danish: Hæmatologisk toksicitet i løbet af en cyklus:
English: Do not store above 30ºC.
Danish: Må ikke opbevares ved over 30 °C.
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 VELCADE 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 VELCADE-gruppen.
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 tumorgenese, inklusive cellevækst og -overlevelse, angiogenese, celle-celle-interaktioner og metastase.
English: 9/l and the absolute neutrophils count should be ≥ 1.0 x 10
Danish: 9/l, og absolut neutrofiltal skal være ≥ 1,0 x 10
English: • bleeding problems and/or low number of platelets in your blood
Danish: • blødningsproblemer og/eller lavt antal blodplader i blodet
English: (usually on the legs) to large bruise-like patches under the skin or tissue
Danish: (sædvanligvis på benene) eller store blå mærker under huden eller vævet.
English: Patients on oral antidiabetic agents receiving VELCADE 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 VELCADE, kan have brug for nøje monitorering af deres blodsukkerniveau og justering af deres antidiabetikadosis.
English: Time to first response in CR + PR Median
Danish: Tid til første respons i CR + PR Median
English: Once weekly VELCADE (cycles 5-9)
Danish: VELCADE en gang om ugen (cyklus 5-9)
English: Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in VcDx 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 VcDx-gruppen og 52/242 [21 %] i VDDx-gruppen).
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 VELCADE, regardless of disease status.
Danish: Som et resultat af den forud planlagte interimanalyse blev dexamethason-gruppen standset på anbefaling fra datamonitoreringskomiteen, og alle patienter som var randomiseret til dexamethason, fik derefter tilbudt VELCADE uanset sygdommens status.
English: • heart or blood pressure problems
Danish: • problemer med hjertet eller blodtrykket
English: Treatment with VELCADE is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Danish: Behandling med VELCADE er meget ofte forbundet med perifer neuropati, som er overvejende sensorisk.
English: Median c(95% CI) (months) Response rate n: response-evaluable patients 229 Overall complete response (CR+CRu)
Danish: Median c (95 % CI) (måneder) Responsrate n: respons-evaluerbare patienter 229 Samlet komplet respons (CR+CRu)
English: Patient demographic and baseline disease charateristics were similar between the treatment groups.
Danish: Patientdemografiske og baseline-sygdomsegenskaber var sammenlignelige behandlingsgrupperne imellem.
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 påvist, at bortezomib er cytotoksisk over for en række cancercelletyper, og at cancerceller er mere følsomme over for pro-apoptotiske virkninger af proteasom-hæmning end normale celler.
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with VELCADE 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 patienter blev behandlet med VELCADE ved 1,3 mg/m2 og er medtaget i tabel 7.
English: OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by Cochran Mantel-Haenszel test.
Danish: OR for responsrater baseret på Mantel-Haenszel skøn af den fælles oddsratio for stratificerede tabeller; p-værdier efter Cochran Mantel-Haenszel test.
English: • Blood clot in small blood vessels (thrombotic microangiopathy)
Danish: • Blodprop i små blodkar (trombotisk mikroangiopati)
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 foregående cyklus
English: • High or low blood pressure
Danish: • Højt eller lavt blodtryk
English: There have been fatal cases of inadvertent intrathecal administration of VELCADE.
Danish: Der er forekommet fatale tilfælde af utilsigtet intratekal administration af VELCADE.
English: • Abnormal protein deposits in your vital organs
Danish: • Unormal aflejring af protein i vigtige organer
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: Intent to Treat Population n=74
Danish: Intention to treat-population n = 74
English: Reduce VELCADE to 0.7 mg/m2 in the first treatment cycle.
Danish: Reducer VELCADE til 0,7 mg/m2 i første behandlingscyklus.
English: tiredness, confusion, blindness or other vision problems.
Danish: træthed, konfusion, blindhed eller andre synsproblemer.
English: • Skin reactions and disorders (which may be severe and life threatening), skin ulcers
Danish: • Hudreaktioner og hudsygdomme (som kan være alvorlige og livstruende), hudsår
English: A hazard ratio < 1 indicates an advantage for VcR-CAP.
Danish: En hazard ratio < 1 angiver en fordel for VcR-CAP.
English: A statistically significant survival benefit in favour of the Vc+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including VELCADE-based regimens.
Danish: Der blev observeret en statistisk signifikant forbedring af overlevelsen i Vc+M+Pbehandlingsgruppen (HR = 0,695; p = 0,00043) til trods for efterfølgende behandlinger, inklusive regimer baseret på VELCADE.
English: At 10 M 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 proteasom end for det næste foretrukne enzym.