FrancophonIA/ELRC3.0 huggingface dataset:
English: Some of these effects may be serious.
Danish: Nogle af bivirkningerne kan være alvorlige.
English: Therefore no dose recommendations can be made in this population.
Danish: Derfor kan der ikke gives nogen dosisanbefalinger til denne population.
English: All these target organs have shown partial to full recovery following discontinuation of treatment.
Danish: Alle disse målorganer har vist partiel til fuld restitution efter ophør af behandlingen.
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: The mechanism of this event is unknown although a component may be due to autonomic neuropathy.
Danish: Mekanismerne ved denne hændelse er ukendt, selvom en komponent kan skyldes autonom neuropati.
English: Some of these events have been fatal.
Danish: Nogle af disse tilfælde har været dødelige.
English: A total of 218 patients were evaluable for response.
Danish: 218 patienter i alt kunne evalueres for respons.
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: Antiviral prophylaxis should be considered.
Danish: Antiviral profylakse skal overvejes.
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 et forbedret respons [MR (11 %) eller PR (7 %)] med kombinationsbehandlingen.
English: Moreover, in dog studies, a slight increase in the corrected QT interval was observed.
Danish: Desuden sås i hundeforsøg en lille stigning i det korrigerede QT-interval.
English: a Based on Independent Review Committee (IRC) assessment (radiological data only).
Danish: a Baseret på bedømmelse fra en uafhængig review-komite (IRC) (kun radiologiske data).
English: Dissolution of the lyophilised powder is completed in less than 2 minutes.
Danish: Opløsning af det frysetørrede pulver sker på under 2 minutter.
English: Bzmb=Bortezomib SUN; M=melphalan, P=prednisone
Danish: Bzmb= Bortezomib SUN; M=melphalan; P=prednison
English: Median follow-up was 16.3 months.
Danish: Median opfølgning var 16,3 måneder.
English: Cluj-Napoca, Judeţul Cluj România
Danish: Cluj-Napoca, Judeţul Cluj
English: You do not need to check the pH of the solution.
Danish: Det er ikke nødvendigt at tjekke opløsningens pH-værdi.
English: This minimises the effects of observed confounders when estimating treatment effects using non-randomised data.
Danish: Dette minimerer effekten af observerede confounders ved estimering af behandlingseffekten ved brug af ikke-randomiserede data.
English: The final analysis for OS performed after a median follow-up of 8.6 years showed no significant difference in OS between the two treatment arms.
Danish: Den endelige analyse af samlet overlevelse (OS), der blev udført efter en median opfølgning på 8,6 år, viste ingen signifikant forskel i OS mellem de to behandlingsarme.
English: Table 7 has been generated using Version 14.1 of the MedDRA.
Danish: Tabel 7 blev genereret ved hjælp af MedDRA version 14.1.
English: Table 8 has been generated using Version 16 of the MedDRA.
Danish: Tabel 8 blev genereret ved hjælp af MedDRA version 16.
English: Due to this early crossover, the median duration of follow-up for surviving patients is 8.3 months.
Danish: På grund af det tidlige cross-over er den mediane varighed af opfølgningen for de overlevende patienter 8,3 måneder.
English: Time related events
Danish: Tidsrelaterede hændelser
English: These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.
Danish: Det kan være tegn på en alvorlig infektion i hjernen, og lægen vil muligvis foreslå nærmere undersøgelser og kontrol.
English: Intrathecal administration has resulted in death.
Danish: Intratekal administration har medført dødsfald.
English: Surgical and medical procedures
Danish: Kirurgiske og medicinske procedurer
English: Treatment was administered for a maximum of 9 cycles (approximately 54 weeks) and was discontinued early for disease progression or unacceptable toxicity.
Danish: Behandlingen blev givet i højst 9 cyklusser (ca. 54 uger) og blev seponeret før tid ved sygdomsprogression eller uacceptabel toksicitet.
English: Neuropathy has been managed with supportive care and other therapies.
Danish: Neuropati er blevet håndteret med understøttende behandling og andre behandlinger.
English: Fertility studies were not performed but evaluation of reproductive tissues has been performed in the general toxicity studies.
Danish: Der er ikke gennemført fertilitetsstudier, men vurdering af reproduktivt væv har fundet sted i generelle toksicitetsstudier.
English: MARKETING AUTHORISATION NUMBER EU/1/16/1102/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/16/1102/001
English: Adverse reactions are listed below by system organ class and frequency grouping.
Danish: Bivirkningerne er angivet nedenfor i henhold til systemorganklasser og frekvensgrupper.
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 responset fastlagt af en uafhængig review-komite, og responskriterierne fra The European Bone Marrow Transplant Group blev brugt.
English: Since patients with neutropenia are at increased risk of infections, they should be monitored for signs and symptoms of infection and treated promptly.
Danish: Eftersom patienter med neutropeni har en øget risiko for infektioner, skal de monitoreres for tegn og symptomer på infektion og omgående behandles.
English: • need to handling the medicinal product in sterile setting
Danish: • at lægemidlet skal håndteres under sterile betingelser
English: Cycles 1 to 4
Danish: Cyklus 1-4
English: In a few cases, patients who have had hepatitis B might have a repeated attack of hepatitis, which can be fatal.
Danish: I nogle få tilfælde kan patienter, som har haft hepatitis B, få et nyt anfald af hepatitis, som kan være dødeligt.
English: Do not use this medicine after the expiry date stated on the vial and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasset og pakningen efter EXP.
English: Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies
Danish: Tabel 14: Resumé af sygdomsresultater fra fase III- (APEX) og fase II-studier
English: Of the 669 patients enrolled, 245 (37%) were 65 years of age or older.
Danish: Ud af de 669 inkluderede patienter var 245 (37 %) 65 år eller ældre.
English: Use of gloves and other protective clothing to prevent skin contact is recommended.
Danish: Det anbefales at bruge handsker og anden beskyttende påklædning for at undgå hudkontakt.
English: If, despite these measures, pregnancy occurs, tell your doctor immediately.
Danish: Hvis du på trods af dette bliver gravid, skal du kontakte lægen med det samme.
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BzmbDx group.
Danish: Den gennemsnitlige behandlingsvarighed var 13 uger for VDDx-gruppen og 11 uger for BzmbDx-gruppen.
English: The median duration of treatment was 24.0 weeks and the median number of treatment cycles received was 6.0, and was consistent across treatment groups.
Danish: Den mediane behandlingsvarighed var 24,0 uger, og det mediane antal behandlingscyklusser var 6,0, hvilket var konsistent for alle behandlingsgrupper.
English: It is, therefore, likely that bortezomib could have a potential effect on either male or female fertility.
Danish: Det er derfor sandsynligt, at bortezomib kan have en potentiel virkning på enten mandlig eller kvindelig fertilitet.
English: These patients should be monitored closely and appropriate precautions taken.
Danish: Sådanne patienter skal monitoreres omhyggeligt, og de nødvendige forholdsregler skal tages.
English: It is not necessary to protect the reconstituted medicinal product from light.
Danish: Det er ikke nødvendigt at beskytte det rekonstituerede produkt mod lys.
English: Response parameters as well as TTP remained significantly better for bortezomib independently of age.
Danish: Responsparametre samt TTP forblev signifikant bedre for bortezomib uafhængigt af alder.
English: The reported efficacy data are considered inconclusive (see section 4.2).
Danish: De indberettede virkningsdata betragtes som inkonklusive (se pkt.
English: Up to 8 cycles of this combination therapy can be administered as long as patients have not progressed and tolerate treatment.
Danish: Der kan gives op til 8 cyklusser af denne kombinationsbehandling, så længe patienterne ikke progredierer og tolererer behandlingen.
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: Day 22
Danish: Dag 22
English: Secondary efficacy endpoints included Progression Free Survival and Overall Survival.
Danish: Sekundære effektendepunkter omfattede progressionsfri overlevelse og samlet overlevelse.
English: May be fatal if given by other routes.
Danish: Kan være dødelig hvis det administreres via andre indgiftsveje.
English: White to off-white lyophilized powder or cake.
Danish: Hvidt til offwhite frysetørret pulver eller kage.
English: Most cases of PML were diagnosed within 12 months of their first dose of bortezomib.
Danish: De fleste tilfælde af PML blev diagnosticeret inden for 12 måneder efter første dosis bortezomib.
English: • Reconstitution poster
Danish: • Poster om rekonstitution
English: The primary endpoint was best confirmed response to retreatment as assessed by EBMT criteria.
Danish: Det primære endepunkt var bedste bekræftede respons på genbehandling vurderet ud fra EBMTkriterierne.
English: Day 8, 11
Danish: Dag 8, 11
English: Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.
Danish: Tal med lægen om, hvornår det er sikkert at genoptage amningen efter din behandling.
English: Similar proportions of patients had creatinine clearance ≤30 ml/min (3% in each arm).
Danish: Tilsvarende andele af patienterne havde kreatininclearance ≤ 30 ml/min (3 % i hver gruppe).
English: Bortezomib should be discontinued if serious reactions occur.
Danish: Bortezomib bør seponeres, hvis der opstår alvorlige reaktioner.
English: Fluid retention may be a predisposing factor for signs and symptoms of heart failure.
Danish: Væskeretention kan være en forudgående faktor for tegn og symptomer på hjerteinsufficiens.
English: No new safety concerns were observed during the study, and in particular bortezomib did not exacerbate target organ damage (heart, kidney and liver).
Danish: Der blev ikke observeret nye sikkerhedsproblemer i løbet af studiet, og navnlig medførte bortezomib ikke forværring af skader på målorganer (hjerte, nyrer og lever).
English: Therefore, caution should be used during handling and preparation.
Danish: Derfor skal der udvises forsigtighed ved håndteringen og præparationen.
English: Proteasomes play an important role in controlling cell function and growth.
Danish: Proteasomer spiller en vigtig rolle i reguleringen af cellers funktion og vækst.
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 udviste de sekundære endepunkter, som var relateret til respons og tid til hændelse, overensstemmende resultater for subkutan og intravenøs administration (tabel 15).
English: Phase III
Danish: Fase III
English: The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Danish: Den mediane overlevelse for alle inkluderede patienter var 17 måneder (interval < 1 til 36+ måneder).
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 hyppighed for resolution af perifer neuropati i dette studie.
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 multivariansanalyse var responsraten uafhængig af myelomtype, performance status, kromosom 13-deletion-status og antallet eller typen af tidligere behandlinger.
English: b Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Danish: b Op til 6 cyklusser kan gives til patienter, der får i det mindste partielt respons efter 4 cyklusser.
English: • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Danish: • oplysning om potentielle risici ved administration - herunder overdosering og underdosering, samt at utilsigtet intratekal administration har ført til dødsfald
English: * Grouping of more than one MedDRA preferred term.
Danish: * Indikerer termer, der omfatter mere end én MedDRA ”foretrukken term”
English: Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Danish: Grad 4 (livstruende konsekvenser, kræver akut intervention) og/eller autonom svær neuropati
English: Potential benefit of the treatment should be carefully weighed against the risks, particularly in case of moderate to severe thrombocytopenia and risk factors for bleeding.
Danish: De mulige fordele ved behandlingen skal nøje afvejes i forhold til risikoen, især ved moderat til svær trombocytopeni og risikofaktorer for blødning.
English: Electrocardiogram investigations
Danish: Elektrokardiogramundersøgelser
English: If a diagnosis of PML is suspected, patients should be referred to a specialist in PML and appropriate diagnostic measures for PML should be initiated.
Danish: Hvis der er mistanke om PML, skal patienterne henvises til en læge med specialviden om PML, og der bør indledes passende diagnostiske undersøgelser for PML.
English: Most patients required treatment for their orthostatic hypotension.
Danish: De fleste patienter havde brug for behandling mod ortostatisk hypotension.
English: However, cases of severe motor neuropathy with or without sensory peripheral neuropathy have been reported.
Danish: Der er imidlertid også rapporteret alvorlige tilfælde af motorisk neuropati med eller uden sensorisk perifer neuropati.
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 dem, der ikke var refraktære, var den samlede overlevelse signifikant længere, og responsraten var signifikant højere i bortezomibgruppen.
English: This 21-day period (3 weeks) corresponds to one treatment cycle.
Danish: Denne periode på 21 dage (3 uger) svarer til én behandlingscyklus.
English: Bortezomib SUN should not be used in children and adolescents because it is not known how the medicine will affect them.
Danish: Bortezomib SUN bør ikke bruges til børn og unge, da det ikke vides, hvordan lægemidlet vil påvirke dem.
English: A protocol-defined interim analysis (based on 249 TTP events) triggered early study termination for efficacy.
Danish: En protokoldefineret interimanalyse (baseret på 249 TTP-hændelser) triggede afslutning af studiet grundet effekt.
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 bortezomib efter dialyse, blev også inkluderet i studiet (n=8).
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 studier; årsagssammenhængen er ikke fastlagt.
English: Injection under the skin is in either the thighs or the abdomen.
Danish: Injektionen under huden gives enten i lårene eller maven.
English: It is recommended that patients with at least partial response receive 2 additional cycles.
Danish: Det anbefales, at patienter med i det mindste partielt respons får 2 ekstra cyklusser.
English: Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems).
Danish: Din læge kan vælge at ændre dosis og antallet af behandlingscyklusser afhængigt af, hvordan du reagerer på behandlingen, forekomsten af visse bivirkninger, og hvilke sygdomme du lider af (f.eks. leverproblemer).
English: Thalidomide causes birth defects and foetal death.
Danish: Thalidomid kan forårsage medfødte misdannelser og fosterdød.
English: Bortezomib is eliminated more rapidly following the first dose compared to subsequent doses.
Danish: Bortezomib elimineres hurtigere efter første dosis end efter de efterfølgende doser.
English: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/Ολλανδία/ Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Danish: Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
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 patierne fik en lokal reaktion på subkutan administration, for det meste rødmen.
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 Bzmb+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 Bzmb+M+P-behandling.
English: In addition, following a search of the worldwide medical and scientific literature carried out for the period covered by this PSUSA and a number of papers reporting safety information, 35 cases of Thrombotic Microangiopathy (TMA) were retrieved.
Danish: Efter en søgning i den globale medicinske og videnskabelige litteratur, der omfattede den periode, som er dækket af denne PSUSA, og et antal præsentationer med sikkerhedsoplysninger, blev der desuden fundet 35 tilfælde af trombotisk mikroangiopati (TMA).
English: Posology modification or delay
Danish: Dosisjustering eller udsættelse
English: A minority of patients with orthostatic hypotension experienced syncopal events.
Danish: En lille gruppe patienter med ortostatisk hypotension oplevede synkopale hændelser.
English: Renal complications are frequent in patients with multiple myeloma.
Danish: Nyrekomplikationer er hyppige hos patienter med myelomatose.
English: The major metabolic pathway is deboronation to form two deboronated metabolites that subsequently undergo hydroxylation to several metabolites.
Danish: Den primære metabolisme er deborering, hvorved der dannes to deborerede metabolitter, som efterfølgende undergår hydroxylering til flere metabolitter.
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, hvis overhovedet eksisterende, og relevansen for mennesker er ukendt.
English: Prior to initiating a new cycle of therapy:
Danish: Før påbegyndelse af en ny behandlingscyklus:
English: Patients with risk factors for or existing heart disease should be closely monitored.
Danish: Patienter med risiko for eller med eksisterende hjertesygdom skal monitoreres nøje.
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 eller forværring af lungesymptomer (f.eks. hoste, dyspnø) er det nødvendigt med en hurtig diagnosticering, og at patienterne behandles i overensstemmelse hermed.
English: The teratogenic potential of bortezomib has not been fully investigated.
Danish: Det teratogene potentiale ved bortezomib er ikke fuldstændigt undersøgt.
English: Based on this review, chalazion/blepharitis is considered associated with the use of bortezomib.
Danish: Baseret på denne gennemgang betragtes chalazion/blefaritis som associeret med brugen af bortezomib.
English: Most adverse reactions are mild to moderate in nature and are observed throughout treatment.
Danish: De fleste bivirkninger er milde til moderate og ses i hele behandlingsperioden.
English: Day -- -- Day
Danish: Dag -- -- Dag
English: By interfering with their function, bortezomib can kill cancer cells.
Danish: Ved at påvirke deres funktion kan bortezomib dræbe kræftceller.
English: The final survival update was performed with a median duration of follow-up of 60.1 months.
Danish: Den endelige opdatering af overlevelsesdata fandt sted med en median opfølgning på 60,1 måneder.
English: Patients whose levels of paraprotein continue to decrease after 8 cycles can also continue for as long as treatment is tolerated and they continue to respond.
Danish: Patienter, hvis paraproteinniveau fortsat falder efter 8 cyklusser, kan også fortsætte, så længe de tolererer behandlingen og fortsat opnår respons.
English: The total storage time for the reconstituted medicinal product should not exceed 8 hours prior to administration.
Danish: Den samlede opbevaringstid for det rekonstituerede lægemiddel bør ikke overstige 8 timer inden administration.
English: Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than 8 cycles.
Danish: Patienter, der opnår et komplet respons, kan fortsætte behandlingen i mindst 2 cyklusser efter første tegn på komplet respons, selv om dette kræver behandling i flere end 8 cyklusser.
English: e Median duration of follow up is 11.8 months
Danish: e Median varighed af opfølgning er 11,8 måneder.
English: The 26S proteasome is a large protein complex that degrades ubiquitinated proteins.
Danish: 26S-proteasom er et stort proteinkompleks, som nedbryder ubiquitinerede proteiner.
English: The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to bortezomib alone.
Danish: Protokollen tillod, at patienterne fik dexamethason, hvis de havde haft et mindre end optimalt respons på bortezomib alene.
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 oplysninger er til læger og sundhedspersonale: Kun hætteglasset med 3,5 mg kan administreres subkutant som beskrevet nedenfor:
English: One hundred and twenty seven matched pairs of patients were identified.
Danish: Der blev identificeret et hundrede og syvogtyve matchede par patienter.
English: After correcting for the BSA effect, other demographics such as age, body weight and sex did not have clinically significant effects on bortezomib clearance.
Danish: Efter korrektion for BSA-virkning havde andre demografiske data som f.eks. alder, legemsvægt og køn ikke klinisk signifikant indvirkning på bortezomib-clearance.