FrancophonIA/ELRC3.0 huggingface dataset:
English: Czech Republic Bayer Schering Pharma AG D-13342 Berlin
Danish: Bayer Schering Pharma AG D-13353 Berlin Germany
English: Finally taking into account that the medicinal product is intended for long term use, the possible mistakes and misuse are further minimised.
Danish: Endelig minimeres muligheden for fejltagelser og forkert anvendelse yderligere, når det tages i betragtning, at lægemidlet er beregnet til langsigtet anvendelse.
English: Marketing autorisation Holder
Danish: Medlems- land Indehaver af markedføringstilladelsen Sœrnavn
English: Some of these events have been fatal.
Danish: Nogle af disse hændelser har været fatale.
English: 1930 Zaventem, Belgium
Danish: 1930 Zaventem, Belgien
English: Date of first authorisation: 25 July 2016
Danish: Dato for første markedsføringstilladelse: 25. juli 2016
English: This will be done by a healthcare professional.
Danish: Dette vil blive sundhedspersonalet gøre.
English: Special handling instructions.
Danish: Særlige instruktioner for håndtering.
English: Therefore no dose recommendations can be made in this population.
Danish: Der kan derfor ikke gives nogen anbefalinger til dosering til denne population.
English: • Diarrhoea: if this happens, it is important that you drink more water than usual.
Danish: • Diaré: Hvis du har diaré, er det vigtigt, at du drikker mere vand, end du plejer.
English: These results, though not mature, constituted the protocol defined final analysis.
Danish: Disse resultater udgjorde, trods det, at de ikke var endelige, den protokoldefinerede endelige analyse.
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: 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 må ikke overstige 8 timer inden administration.
English: All these target organs have shown partial to full recovery following discontinuation of treatment.
Danish: Alle disse målorganer har udvist delvis til fuld restitution efter seponering af behandlingen.
English: Median follow-up was 16.3 months.
Danish: Medianopfølgningen var 16,3 måneder.
English: Response rate n: response-evaluable patients
Danish: Responsrate n: respons-evaluerbare patienter
English: • Inability to produce enough insulin or resistance to normal levels of insulin
Danish: • Manglende evne til at danne tilstrækkeligt insulin eller resistens over for normale insulinniveauer
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: Potentially immunocomplex-mediated reactions
Danish: Potentielt immunkompleks-medierede reaktioner
English: Eighteen percent of patients achieved, or had an improved response [MR (11%) or PR (7%)] with combination treatment.
Danish: 18% af patienterne opnåede eller havde et forbedret respons [MR (11%) eller PR (7%)] med kombinationsbehandlingen.
English: A total of 218 patients were evaluable for response.
Danish: I alt 218 patienters respons kunne evalueres.
English: Based on Independent Review Committee (IRC) assessment (radiological data only).
Danish: Baseret på en bedømmelse fra en uafhængig review-komité (IRC) (kun radiologiske data).
English: Moreover, in dog studies, a slight increase in the corrected QT interval was observed.
Danish: I hundeforsøg ses desuden en lille stigning i det korrigerede QT-interval.
English: The mechanism of this event is unknown although a component may be due to autonomic neuropathy.
Danish: Mekanismen bag denne hændelse er ukendt, selvom en del af den kan skyldes autonom neuropati.
English: Injection into a vein is rapid, taking 3 to 5 seconds.
Danish: Injektionen ind i en vene sker hurtigt og tager cirka 3 til 5 sekunder.
English: • Breakdown of muscle fibers leading to other complications
Danish: • Nedbrydning af muskelfibre, der fører til andre komplikationer
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 medianoverlevelsen på 6-9 måneder, der var forventet af de rådgivende kliniske investigatorer for en lignende patientpopulation.
English: Bilirubin level
Danish: Bilirubinniveau
English: Use of gloves and other protective clothing to prevent skin contact is recommended.
Danish: Det anbefales at bruge handsker og anden beskyttende beklædning for at undgå hudkontakt.
English: Peri- and postnatal development studies were not conducted.
Danish: Der er ikke udført forsøg af den peri- og postnatale udvikling.
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 crossover er medianvarigheden af opfølgning på de overlevende patienter 8,3 måneder.
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 maksimalt 9 cyklusser (ca. 54 uger) og blev seponeret før tid ved sygdomsprogression eller uacceptabel toksicitet.
English: In particular, tell your doctor if you are using medicines containing any of the following active substances:
Danish: Du skal særligt fortælle det til lægen, hvis du bruger medicin, som indeholder følgende aktive stoffer:
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 medianopfølgning på 8,6 år, viste ingen signifikant forskel i OS mellem de 2 behandlingsgrupper.
English: Table 7 has been generated using Version 14.1 of the MedDRA.
Danish: Tabel 7 er blevet udarbejdet med anvendelse af MedDRA version 14.1.
English: Table 8 has been generated using Version 16 of the MedDRA.
Danish: Tabel 8 er blevet udarbejdet med anvendelse af MedDRA version 16.
English: These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.
Danish: Dette kan være tegn på en alvorlig infektion i hjernen, og lægen vil muligvis foreslå nærmere undersøgelser og kontrol
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 behandles omgående.
English: Two (1%) of the patients had severe reactions; 1 case of pruritus and 1 case of redness.
Danish: 2 (1%) af patienterne havde svære reaktioner; 1 tilfælde af pruritus og 1 tilfælde af rødme.
English: Cycles 1 to 4
Danish: Cyklus 1 til 4
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BDx group.
Danish: Medianvarighed af behandlingen var 13 uger for VDDx-gruppen og 11 uger for BDxgruppen.
English: These patients should be monitored closely and appropriate precautions taken.
Danish: Sådanne patienter skal monitoreres nøje, og de nødvendige forholdsregler skal tages.
English: Each pack contains 1 single-use vial.
Danish: Hver pakning indeholder 1 engangshætteglas.
English: Your doctor may give you another medicine to control diarrhoea
Danish: Lægen kan give dig medicin til behandling af diaréen
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: 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: Frekvensgrupperne 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: A group of dialysis patients who were dosed after dialysis was also included in the study (n=8).
Danish: En gruppe dialysepatienter, som blev behandlet efter dialyse, blev også inkluderet i forsøget (n=8).
English: Secondary efficacy endpoints included Progression Free Survival and Overall Survival.
Danish: De sekundære effektendepunkter omfattede progressionsfri overlevelse og samlet overlevelse.
English: • Haemoglobin ≥ 8 g/dL
Danish: • Hæmoglobin ≥ 8 g/dl
English: Table 14: Summary of disease outcomes from the Phase III (APEX) and Phase II studies Phase III
Danish: Tabel 14: Resumé af sygdomsresultater fra fase III- (APEX) og fase II-forsøg Fase III
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-forsøget blev responset fastlagt af en uafhængig review-komite, og responskriterierne fra The European Bone Marrow Transplant Group blev brugt.
English: The reported efficacy data are considered inconclusive (see section 4.2).
Danish: De indberettede effektdata betragtes som værende utilstrækkelige (se pkt.
English: White to off-white cake or powder.
Danish: Hvid til offwhite masse eller pulver.
English: The final survival update was performed with a median duration of follow-up of 60.1 months.
Danish: Den endelige opdatering af overlevelsesdata blev udført med en medianopfølgning på 60,1 måneder.
English: # Post-marketing adverse reaction regardless of indication
Danish: MedDRA # Indberetninger efter markedsføring, uanset indikation
English: This minimises the effects of observed confounders when estimating treatment effects using non-randomised data.
Danish: Dette minimerer effekterne af observerede, forvekslelige faktorer, når behandlingseffekten skal estimeres med anvendelse af ikke-randomiserede data.
English: The educational material shall consist of the following:
Danish: Uddannelsesmaterialet skal bestå af følgende:
English: • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Danish: • Information om de potentielle risici ved administrationsfejl, herunder overdosering og underdosering, og om, at utilsigtet intratekal administration har ført til dødsfald
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: Sleep disorders and disturbances*
Danish: Søvnlidelser og -forstyrrelser*
English: One hundred and twenty seven matched pairs of patients were identified.
Danish: Der blev identificeret 127 matchede par patienter.
English: Fluid retention may be a predisposing factor for signs and symptoms of heart failure.
Danish: Væskeretention kan være en prædisponerende faktor for tegn og symptomer på hjerteinsufficiens.
English: In the 6-month rat study, degenerative effects in both the testes and the ovary have been observed.
Danish: I forsøg med 6-måneder gamle rotter er der set degenerative virkninger på både testikler og ovarier.
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 risiciene, især ved moderat til svær thrombocytopeni og risikofaktorer for blødning.
English: There was no evidence of cumulative thrombocytopenia.
Danish: Der var ingen tegn på kumulativ thrombocytopeni.
English: Fertility studies were not performed but evaluation of reproductive tissues has been performed in the general toxicity studies.
Danish: Der er ikke gennemført fertilitetsforsøg, men undersøgelser af reproduktivt væv har fundet sted i generelle toksicitetsforsøg.
English: Proteasomes play an important role in controlling cell function and growth.
Danish: Proteasomer spiller en vigtig rolle i reguleringen af cellernes funktion og vækst.
English: * Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
Danish: * Baseret på doseringsændringer i fase II- og III-forsøg af myelomatose og erfaring efter markedsføring.
English: Most patients required treatment for their orthostatic hypotension.
Danish: De fleste patienter havde brug for behandling af den ortostatiske hypotension.
English: AST=aspartate aminotransferase; ULN=upper limit of the normal range.
Danish: ASAT = aspartataminotransferase; ULN = øvre grænse for normalområdet.
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 nogen nye sikkerhedsmæssige problemer i løbet af forsøget, og navnlig førte bortezomib ikke til forværring af skader på målorganer (hjerte, nyrer og lever).
English: Horizon, Honey Lane Hurley, SL66RJ United Kingdom
Danish: Horizon, Honey Lane Hurley, SL6 6RJ Storbritannien
English: Overall, bortezomib was administered for the treatment of multiple myeloma in 3,974 patients.
Danish: Samlet set blev bortezomib indgivet til behandling af myelomatose hos 3.974 patienter.
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 dyreforsøg synes bortezomibs penetration gennem blod-/hjerne-barrieren at være begrænset, om overhovedet nogen, og relevansen for mennesker er ukendt.
English: Response population includes patients who had measurable disease at baseline CR=Complete Response; PR=Partial Response.
Danish: Responspopulation omfatter patienter, som havde målbar sygdom ved baseline CR = komplet respons; PR = partielt respons.
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 hvert medlemsland skal indehaveren af markedsføringstilladelsen være enig med den nationale kompetente myndighed om indholdet og formatet af uddannelsesmaterialet.
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 B+M+P treatment.
Danish: På tidspunktet for en forudspecificeret interimanalyse var det primære endepunkt, tid indtil progression, opnået, og patienterne i M+P-gruppen blev tilbudt B+M+P-behandling.
English: b Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Danish: b Der kan gives op til 6 cyklusser til patienter, der som et minimum opnår partielt respons efter 4 cyklusser
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 endepunkter, som var relateret til respons og tid indtil hændelse, overensstemmende resultater for subkutan og intravenøs administration (tabel 15).
English: Haematological toxicity during a cycle
Danish: Hæmatologisk toksicitet under en cyklus
English: The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Danish: Medianoverlevelsen for alle inkluderede patienter var 17 måneder (interval < 1-36+ måneder).
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, der havde fået 2-3 tidligere behandlingsregimer, havde en responsrate på 32% (10/32), og patienter, der havde fået mere end 7 tidligere behandlingsregimer, havde en responsrate på 31% (21/67).
English: • moderate to severe liver problems
Danish: • moderate til alvorlige leverproblemer
English: Therefore, caution should be used during handling and preparation.
Danish: Derfor skal der udvises forsigtighed ved håndtering og klargøring.
English: The resulting solution is then either injected into a vein or under the skin.
Danish: Opløsningen bliver derefter injiceret ind i en vene eller ind under huden.
English: Six percent of patients had an adverse local reaction to subcutaneous administration, mostly redness.
Danish: 6% af patienterne fik en lokal reaktion på den subkutane administration, fortrinsvis rødmen.
English: • Confirm the dose and concentration in the syringe prior to use (check that the syringe is markedas intravenous administration).
Danish: • Kontrollér dosis og koncentrationen i sprøjten før brug (kontrollér, at sprøjten er mærket til intravenøs administration).
English: Management of orthostatic/postural hypotension may include adjustment of antihypertensive medicinal products, rehydration or administration of mineralocorticosteroids and/or sympathomimetics.
Danish: Behandlingen af ortostatisk/postural hypotension kan omfatte justering af antihypertensiva, rehydrering eller administration af mineralkortikosteroider og/eller sympatomimetika.
English: Posology modification or delay
Danish: Doseringsændring eller udsættelse
English: Manufacturer Hospira UK Ltd.
Danish: Fremstiller Hospira UK Ltd.
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Danish: Thalidomid er et kendt teratogent aktivt stof, der forårsager alvorlige, livstruende fødselsdefekter.
English: • Inability to tolerate alcohol consumption
Danish: • Intolerans over for alkohol
English: Do not give by other routes.
Danish: Det må ikke gives via andre administrationsveje.
English: Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Danish: Grad 4 (livstruende følger; akut indgriben nødvendig) og/eller svær autonom neuropati
English: Bortezomib should not be used in children and adolescents because it is not known how the medicine will affect them.
Danish: Bortezomib Hospira må ikke bruges til børn og unge, da det ikke vides, hvordan medicinen vil påvirke dem.
English: Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Danish: Tildeling af grad baseret på NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
English: Patient demographic and baseline disease characteristics were similar between the treatment groups.
Danish: Patientdemografi og sygdomskarakteristika ved baseline var sammenlignelige behandlingsgrupperne imellem.
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 komplet respons, kan fortsætte behandlingen i mindst 2 cyklusser efter første tegn på komplet respons, også selv om dette kræver behandling i flere end 8 cyklusser.
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) udløste afslutning af forsøget grundet effekt.
English: • need to handling the medicinal product in sterile setting
Danish: • Information om behovet for, at lægemidlet håndteres under sterile betingelser
English: The 26S proteasome is a large protein complex that degrades ubiquitinated proteins.
Danish: 26S-proteasomet er et stort proteinkompleks, som nedbryder ubiquitinerede proteiner.
English: In patients with MCL, transient neutropenia that was reversible between cycles was observed, with no evidence of cumulative neutropenia.
Danish: Hos patienter med MCL blev der observeret forbigående neutropeni, som var reversibel mellem cyklusserne og uden evidens for kumulativ neutropeni.
English: In patients, overdose more than twice the recommended dose has been associated with the acute onset of symptomatic hypotension and thrombocytopenia with fatal outcomes.
Danish: Hos patienter er overdosering med mere end det dobbelte af den anbefalede dosis blevet forbundet med akut symptomatisk hypotension og thrombocytopeni med fatale udfald.
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: Medianvarighed af behandlingen var 24,0 uger, og medianantal behandlingscyklusser var 6,0, hvilket var ens for alle behandlingsgrupper.
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BR-CAP arm and with at least a possible or probable causal relationship to the components of the BR-CAP arm, are listed in Table 8 below.
Danish: Lægemiddelbivirkninger, identificeret med en forekomst på ≥ 1%, tilsvarende eller højere forekomst i BR-CAP-gruppen og med mindst en mulig eller sandsynlig kausal sammenhæng med komponenterne i BR-CAP-gruppen, er anført i tabel 8 nedenfor.
English: Very Common Decreased appetite Common
Danish: Meget almindelig Nedsat appetit Almindelig
English: However, cases of severe motor neuropathy with or without sensory peripheral neuropathy have been reported.
Danish: Der er imidlertid også indberettet alvorlige tilfælde af motorisk neuropati med eller uden sensorisk perifer neuropati.
English: Reduction in serum M-protein population g n=667
Danish: Reduktion i serum-M-protein Population g n=667
English: Regardless of β2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the bortezomib arm.
Danish: Uanset β2-mikroglobulintal ved baseline var alle effektparametre (tiden indtil progression og samlet overlevelse samt responsrate) signifikant forbedrede i bortezomib-gruppen.
English: tiredness, confusion, blindness or other vision problems.
Danish: træthed, forvirring, blindhed eller andre synsproblemer.
English: Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Danish: Bortezomib-medieret proteasomhæmning påvirker cancerceller på flere måder, herunder - men ikke begrænset til - ændring af regulatorproteiner, som styrer cellecyklusprogressionen og aktiveringen af nuklear faktor kappa B (NF-κB).
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-effekt har andre demografiske data såsom alder, legemsvægt og køn ikke nogen klinisk signifikante virkninger på bortezomibs clearance.
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 2 deborerede metabolitter, som efterfølgende gennemgår hydroxylering til flere metabolitter.
English: Treatment with bortezomib can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Danish: Behandlingen med bortezomib kan meget ofte forårsage et fald i antallet af røde og hvide blodlegemer samt blodplader i blodet.
English: A vial is for single use only and the remaining solution must be discarded.
Danish: Et hætteglas er kun beregnet til engangsbrug, og resterende opløsning skal kasseres.
English: Your doctor will work out your dose of bortezomib according to your height and weight (body surface area).
Danish: Din læge vil fastlægge din dosis af bortezomib ud fra din højde og vægt (legemsoverfladeareal).
English: • Abnormal protein deposits in your vital organs
Danish: • Unormal aflejring af protein i vitale organer