FrancophonIA/ELRC3.0 huggingface dataset:
English: Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving VELCADE.
Danish: Posteriort reversibelt encefalopatisk syndrom (PRES) Der er indberettet PRES hos patienter, der fik VELCADE.
English: AST=aspartate aminotransferase; ULN=upper limit of the normal range.
Danish: Forkortelser: ASAT = aspartat-aminotransferase, ULN = øvre grænse for normalområdet.
English: Herpes zoster virus reactivation
Danish: Herpes zoster virusreaktivering
English: Incidence of PN (%) All GradePN  Grade 2 PN  Grade 3 PN
Danish: Forekomst af PN (%) Alle grader PN ≥ Grad 2 PN ≥ Grad 3 PN
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 (VELCADE plus dexamethasone, and VELCADE 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 (VELCADE plus dexamethason og VELCADE plus dexamethason og thalidomid).
English: Median survival for the Vc+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Danish: Den mediane overlevelse i Vc+M+P-behandlingsgruppen var 56,4 måneder sammenlignet med 43,1 i M+P-behandlingsgruppen.
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: 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 VELCADE.
Danish: Bærere af hepatitis B og patienter med en anamnese med hepatitis B skal nøje monitoreres for kliniske og laboratoriemæssige tegn på aktiv HBV-infektion under og efter rituximab-kombinationsbehandling med VELCADE.
English: Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to VELCADE.
Danish: Bivirkningerne i tabel 7 ansås af investigatorerne for mindst at have en mulig eller sandsynlig årsagsmæssig sammenhæng med VELCADE.
English: Intent to Treat (ITT) population 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 p-værdi fra den stratificerede log-rank test; analyse ud fra behandling udelukker opdeling på tidligere behandling; p < 0,0001
English: Orthostatic/postural hypotension was not acutely related to bolus infusion of VELCADE.
Danish: Ortostatisk/postural hypotension var ikke akut relateret til bolusinjektion af VELCADE.
English: Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with VELCADE.
Danish: Fase II-studiet MMY-2036 (RETRIEVE), et åbent studie med en enkelt arm, blev udført for at bestemme virkning og sikkerhed af genbehandling med VELCADE.
English: • Cysts in the lining of joints (synovial cysts)
Danish: • Cyster i ledkapslerne (synoviale cyster)
English: At least 72 hours should elapse between consecutive doses of VELCADE.
Danish: Der skal gå mindst 72 timer mellem 2 doser VELCADE.
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 studier havde bortezomib ingen indvirkning på den embryonale/føtale udvikling hos rotter og kaniner ved den højest tålte dosis hos mater.
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the VcR-CAP arm.
Danish: Antiviral profylakse blev administreret til 137 af 240 patienter (57 %) i VcR-CAP-armen.
English: 9/l on a VELCADE dosing day (other than day 1)
Danish: 9/l på en VELCADE-dosisdag (bortset fra dag 1)
English: • Hypersensitivity (allergic reaction)
Danish: • Overfølsomhed (allergisk reaktion)
English: The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. VELCADE in combination with dexamethasone) and patients in the comparison group (e.g. VELCADE) are made comparable with respect to confounding factors by individually pairing study subjects.
Danish: "Matchet par"-analysen er en statistisk metode i hvilken patienter i behandlingsgruppen (f.eks. VELCADE i kombination med dexamethason) og patienter i sammenligningsgruppen (f.eks. VELCADE) gøres sammenlignelige med hensyn til confounding faktorer ved individuelt at sammensætte forsøgspersonerne i par.
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 adskiller sig fra proteasom med et t½ på 20 minutter, hvilket påviser, at proteasomhæmning ved hjælp af bortezomib er reversibel.
English: You may also be given VELCADE together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Danish: Du kan ligeledes få VELCADE sammen med lægemidlerne pegyleret liposomal doxorubicin eller dexamethason.
English: Therefore, platelet counts should be monitored prior to each dose of VELCADE.
Danish: Trombocyttallet skal derfor monitoreres før hver VELCADE-dosis.
English: • Budd-Chiari syndrome (the clinical symptoms caused by blockage of the hepatic veins)
Danish: • Budd-Chiaris syndrom (de kliniske symptomer på blokering af levervenerne)
English: Both men and women receiving VELCADE must use effective contraception during and for up to 3 months after treatment.
Danish: Både mænd og kvinder, som er i behandling med VELCADE, skal anvende sikker prævention under og op til 3 måneder efter behandlingen.
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 og blod/protein i urinen, væskeophobning
English: • ≥ 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 mere end 7 dage, trombocyttal < 10 x 10 9 celler/l
English: It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of VELCADE therapy.
Danish: Det anbefales ligeledes, at responderende patienter, som ikke opnår fuldstændig remission, gennemgår i alt 8 behandlingscyklusser med VELCADE.
English: Regardless of 2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the VELCADE arm.
Danish: Uanset β2-mikroglobulintal ved baseline var alle effektparametre (tiden indtil progression og samlet overlevelse samt responsrate) signifikant forbedrede i VELCADE-gruppen.
English: • If, after VELCADE has been held, the toxicity does not resolve, as defined above, then VELCADE must be discontinued.
Danish: • Hvis toksiciteten ikke forsvinder efter, at VELCADE har været indstillet som defineret ovenfor, skal VELCADE seponeres.
English: Clinical efficacy with subcutaneous administration of VELCADE in patients with relapsed/refractory multiple myeloma
Danish: Klinisk virkning ved subkutan administration af VELCADE hos patienter med recidiverende/refraktær myelomatose
English: The incidence of all grade peripheral neuropathy with VELCADE administered intravenously was lower in the historical studies with VELCADE administered intravenously than in study MMY-3021.
Danish: Forekomsten af alle grader af perifer neuropati efter intravenøs administration af VELCADE var lavere i de ældre studier med VELCADE administreret intravenøst end i studie MMY-3021.
English: The MAH shall ensure thatall healthcare professionals involved in the prescribing, dispensing, handling or administration of VELCADE 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 VELCADE, forsynes med uddannelsespakken.
English: Instructions for reconstitution
Danish: Instruktioner for rekonstitution
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 effektendepunkter inkluderede tid til progression (TTP), tid til næste anti-lymfombehandling (TNT), varighed af behandlingsfrit interval (TFI), samlet responsrate (ORR) og komplet respons (CR/CRu)-rate, samlet overlevelse (OS) og responsvarighed.
English: If you have mantle cell lymphoma and are given the medicine rituximab with VELCADE you should tell your doctor:
Danish: Hvis du har mantle-celle-lymfom og får lægemidlet rituximab sammen med VELCADE, skal du fortælle det til din læge:
English: The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Danish: Den gennemsnitlige eliminationshalveringstid (t1/2) for bortezomib efter gentagne doser var mellem 40-193 timer.
English: The similar incidences of these events in both treatment arms, indicated that these adverse drug reactions are not attributable to VELCADE alone.
Danish: Forekomsten af disse hændelser var sammenlignelig i de to behandlingsarme, hvilket tyder på, at disse bivirkninger ikke udelukkende kan tilskrives VELCADE.
English: • VELCADE 3.5 mg can be administered both intravenously and subcutaneously while VELCADE 1 mg can be administered only intravenously
Danish: • at VELCADE 3,5 mg kan administreres enten intravenøst eller subkutant, mens VELCADE 1 mg kun må administreres intravenøst
English: An effective re-induction multi-agent chemotherapy regimen was administered in 3 blocks.
Danish: Der blev administreret et effektivt reinduktionskemoterapiregime med flere stoffer i 3 blokke.
English: Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors.
Danish: Deborerede bortezomibmetabolitter er inaktive som 26S-proteasomhæmmere.
English: Additional adverse drug reactions identified associated with the use of the combination therapy (VcR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Danish: Yderligere bivirkninger, som blev identificeret i forbindelse med brug af kombinationsbehandling (VcR-CAP), var hepatitis B-infektion (< 1 %) og myokardie-iskæmi (1,3 %).
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, konfusion, blindhed og andre visuelle og neurologiske forstyrrelser.
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were
Danish: Den geometriske gennemsnitsratio AUClast var 0,99, og 90 % konfidensintervaller var 80,18 %
English: TTP, months (95% CI)
Danish: TTP, måneder (95 % CI)
English: Patients who developed orthostatic hypotension on VELCADE (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with VELCADE.
Danish: Patienter, der udviklede ortostatisk hypotension ved VELCADE (som intravenøs injektion) viste ikke tegn på ortostatisk hypotension før behandlingen med VELCADE.
English: Antiviral prophylaxis is recommended in patients being treated with VELCADE.
Danish: Antiviral profylakse anbefales hos patienter, der bliver behandlet med VELCADE.
English: Median a response duration
Danish: Median a responsvarighed
English: Antiviral prophylaxis was administered to 26% of the patients in the Vc+M+P arm.
Danish: Antiviral profylakse blev administreret til 26 % af patienterne i Vc+M+P-gruppen.
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 Endepunkt
English: • Low blood pressure, sudden fall of blood pressure on standing which may lead to fainting
Danish: • Lavt blodtryk, pludseligt blodtryksfald i stående stilling, som kan medføre besvimelse
English: In the Phase II study, patients who did not obtain an optimal response to therapy with VELCADE alone were able to receive high-dose dexamethasone in conjunction with VELCADE.
Danish: I fase II-studiet kunne de patienter, som ikke havde en optimal respons på behandlingen med VELCADE alene, få højdosis dexamethason sammen med VELCADE.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: VELCADE treatment is commonly associated with orthostatic/postural hypotension.
Danish: Behandlingen med VELCADE forbindes almindeligvis med ortostatisk/postural hypotension.
English: • Heart problems to include heart attack, angina
Danish: • Hjerteproblemer inklusive hjerteanfald, angina pectoris
English: Rare cases of hepatic failure have been reported in patients receiving VELCADE and concomitant medicinal products and with serious underlying medical conditions.
Danish: Der er rapporteret sjældne tilfælde af leversvigt hos patienter, der får VELCADE og andre lægemidler samtidig og med alvorlige tilgrundliggende helbredsproblemer.
English: On the basis of the scientific conclusions for bortezomib the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing bortezomib is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for bortezomib er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder bortezomib, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: The reconstituted solution should be used immediately after preparation.
Danish: Den rekonstituerede opløsning skal anvendes umiddelbart efter præparering.
English: Overall, VELCADE was administered for the treatment of multiple myeloma in 3,974 patients.
Danish: Samlet blev VELCADE givet til 3.974 patienter til behandling af myelomatose.
English: Table 12: Efficacy results from study IFM-2005-01
Danish: Tabel 12: Effektresultater fra studiet IFM-2005-01
English: Also included are adverse drug reactions identified in the VcR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to VELCADE based on historical data in the multiple myeloma studies.
Danish: Den inkluderer desuden bivirkninger, som blev identificeret i VcR-CAP-armen, og som af investigatorerne blev anset for at have mindst en mulig eller sandsynlig årsagssammenhæng med VELCADE, baseret på historiske data i myelomatosestudierne.
English: Combination with dexamethasone
Danish: Kombination med dexamethason
English: Discontinuation due to PN (%)
Danish: Seponering på grund af PN (%)
English: Day 1, 4
Danish: Dag 1, 4
English: Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with VELCADE.
Danish: På grund af risiko for alvorlige bivirkninger hos ammede børn bør amning ophøre under behandling med VELCADE.
English: What you need to know before you use VELCADE
Danish: Det skal du vide, før du begynder at bruge VELCADE
English: An open label, randomised, Phase III non-inferiority study compared the efficacy and safety of the subcutaneous administration of VELCADE versus the intravenous administration.
Danish: Der er gennemført et åbent, randomiseret, fase III noninferiority-studie til sammenligning af effekt og sikkerhed af subkutan administration af VELCADE versus intravenøs administration.
English: Patients who had received 2 to 3 prior therapeutic regimens had a response rate of 32% (10/32) and patients who received greater than 7 prior therapeutic regimens had a response rate of 31% (21/67).
Danish: Patienter, som havde fået 2 eller 3 tidligere behandlinger, havde en responsrate på 32 % (10/32) og patienter, som havde fået mere end 7 tidligere behandlinger, havde en responsrate på 31 % (21/67).
English: 42.9% and 10.4% of patients in the VcR-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 VcR-CAP-armen var i alderen 65-74 år og ≥ 75 år.
English: The educational material shall consist of the following:
Danish: Uddannelsespakken skal omfatte følgende:
English: The majority of the patients in both groups completed treatment, 80% in the VcR-CAP group and 82% in the R-CHOP group.
Danish: Størstedelen af patienterne i begge grupper fuldførte behandlingen, 80 % i VcR-CAP-gruppen og 82 % i R-CHOP-gruppen.
English: restlessness or agitation, changes in your mental status, disorientation
Danish: rastløshed eller ophidselse, ændringer i sindstilstand, desorientering
English: This medicine is for intravenous use only.
Danish: Dette lægemiddel er kun til intravenøs anvendelse.
English: Response Evaluable Population n=73
Danish: Population evaluerbar for respons n = 73
English: Hepatitis B Virus (HBV) reactivation and infection When rituximab is used in combination with VELCADE, 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 VELCADE, skal patienter, som har risiko for infektion med HBV, altid screenes for HBV, inden behandlingen startes.
English: bleeding of the eye
Danish: blødning fra øjnene
English: Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: 2-microglobulin, albumin, and region.
Danish: Estimatet af Hazard ratio er baseret på Cox' proportionelle risikomodel justeret for stratifikationsfaktorer: 2mikroglobulin, albumin og region.
English: The benefit/risk ratio should be considered prior to continuing VELCADE therapy.
Danish: Forholdet mellem fordele og risici skal overvejes, før behandlingen med VELCADE fortsætter.
English: Special care is required when treating patients with any risk factors for seizures.
Danish: Der skal udvises særlig forsigtighed, ved behandling af patienter med risikofaktorer for kramper.
English: Normal liver function should be confirmed and caution should be exercised in patients receiving oral hypoglycemics (see section 4.5).
Danish: Normal leverfunktion skal bekræftes, og der skal udvises forsigtighed ved patienter, der behandles med orale hypoglykæmika (se pkt.
English: • If platelet counts ≤ 30 x 10
Danish: • Hvis trombocyttallet er ≤ 30 x 10
English: • A severe reversible brain condition which includes seizures, high blood pressure, headaches,
Danish: • En alvorlig, reversibel tilstand i hjernen, der omfatter krampeanfald, højt blodtryk, hovedpine,
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 bortezomibs koncentrationsinterval på 0,01-1,0 µg/ml var in vitro proteinbindingen gennemsnitligt 82,9 % i humant plasma.
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Danish: Perifer neuropati ≥ grad 3 forekom hos 6 % af patienterne i den subkutane behandlingsgruppe sammenlignet med 16 % i den intravenøse behandlingsgruppe (p = 0,0264).
English: 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: M (9 mg/m P (60 mg/m
Danish: M (9 mg/m P (60 mg/m da g 1
English: Modification of starting dose
Danish: Justering af initialdosis
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 middel (%CV) for clearance var 7,79 (25 %) l/t/m2, fordelingsvolumen ved steady state var 834 (39 %) l/m2 og eliminationshalveringstiden var 100 (44 %) timer.
English: Only the 3.5 mg vial can be administered subcutaneously, as described below.
Danish: Kun hætteglasset med 3,5 mg kan administreres subkutant som beskrevet nedenfor:
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 på grund af perifer neuropati var 8 % lavere i den subkutane gruppe i forhold til den intravenøse gruppe.
English: Early and regular monitoring for symptoms of treatment-emergent neuropathy with neurological evaluation should be considered in patients receiving VELCADE 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 VELCADE i kombination med lægemidler, der vides at være forbundet med neuropati (fx thalidomid), og passende dosisreduktion eller behandlingsseponering skal overvejes.
English: Turnhoutseweg 30 B-2340 Beerse Belgium
Danish: Turnhoutseweg 30 B-2340 Beerse Belgien
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 kaukasere og medianen for Karnofsky performance status var en score på 80.
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) i koncentrationer så lave som 3,125 µg/ml, som var den lavest vurderede koncentration.
English: Patients who did not obtain an optimal response (less than Complete Response [CR]) to therapy with VELCADE alone after 4 cycles were allowed to receive dexamethasone 20 mg daily on the day of and after VELCADE administration.
Danish: Patienter, der ikke opnåede et optimalt respons (mindre end et komplet respons [CR]) på behandlingen med VELCADE alene efter 4 cyklusser, fik desuden dexamethason 20 mg dagligt dagen før og efter administration af VELCADE.
English: In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and 4.4).
Danish: I tilfælde af overdosering skal patientens vitale tegn monitoreres, og der skal ydes relevant, støttende behandling for at opretholde blodtrykket (f.eks. væske, pressorer og/eller inotropiske midler) og kropstemperatur (se pkt.