natgillin/translations-raw huggingface dataset:
Anafylatisk reaktion
Anaphylactic reaction
Anagni (FR) Italien
Anagni (FR) Italy
Anagrelid hæmmer PDE III.
Anagrelide is an inhibitor of PDE III.
Anagrelid kan medføre intestinal forstyrrelse hos nogle patienter og skade absorberingen af hormonal, oral antikonception.
Anagrelide may cause intestinal disturbance in some patients and compromise the absorption of hormonal oral contraceptives.
Anagrelid metaboliseres primært ved CYP1A2.
Anagrelide is primarily metabolised by CYP1A2.
Anagrelid udviser begrænset hæmmende aktivitet over for CYP1A2, hvilket kan udgøre en teoretisk mulighed for interaktion med andre samtidigt indgivne lægemidler, der har samme clearance mekanisme, f.eks. theophyllin.
Anagrelide demonstrates some limited inhibitory activity towards CYP1A2 which may present a theoretical potential for interaction with other co-administered medicinal products sharing that clearance mechanism e.g. theophylline.
Anagrelids sikkerhed og virkning er ikke klarlagt.
The safety and efficacy of anagrelide in children has not been established.
Anagrelids sikkerhed og virkning som et middel til reduktion af blodpladerne er vurderet i fire open- label, ikke-kontrollerede kliniske undersøgelser (undersøgelsesnummer 700-012, 700-014, 700-999 og 13970-301), der omfattede mere end 4000 patienter med myeloproliferative sygdomme (MPD).
The safety and efficacy of anagrelide as a platelet lowering agent have been evaluated in four open- label, non-controlled clinical trials (study numbers 700-012, 700-014, 700-999 and 13970-301) including more than 4000 patients with myeloproliferative disorders (MPDs).
anakinra abatacept
anakinra abatacept.
Anakinra blokerer interleukin-1’s aktivitet ved at binde sig til de receptorer, som interleukin-1 normalt ville binde sig til, og medvirker dermed til at mindske disse sygdomssymptomer.
By attaching to the receptors that interleukin 1 would normally attach itself to, anakinra blocks the activity of interleukin 1, helping to relieve the symptoms of these diseases.
Anakinra har ikke vist nogen effekt på fertilitet, tidlig udvikling, embryo/fosterudvikling eller peri- eller postnatal udvikling hos rotter i doser op til 100 gange den humane dosis.
Anakinra had no observed effect on the fertility, early development, embryo-foetal development, or peri- and postnatal development in the rat at doses up to 100 times the human dose.
Anakinra neutraliserer den biologiske aktivitet af interleukin-1 (IL-1) og interleukin-1 (IL-1) ved kompetitiv hæmning af bindingen til interleukin-1 type I receptor (IL-1RI).
Anakinra neutralises the biologic activity of interleukin-1α (IL-1α) and interleukin-1β (IL-1β) by competitively inhibiting their binding to interleukin-1 type I receptor (IL-1RI).
Anakinras sikkerhed og virkning i kombination med methotrexat er blevet påvist hos 1790 RA- patienter 18 år med forskellig sværhedsgrad af sygdom.
The safety and efficacy of anakinra in combination with methotrexate have been demonstrated in 1790 RA patients  18 years of age with varying degrees of disease severity.
Anal blødning
Anal haemorrhage
anal fistel (en lille passage, der dannes mellem endetarmsåbningen og den omgivende hud)
anal fistula (a small channel that forms between the anus and the surrounding skin)
Anal fistel Flatulens
Dyspepsia
anal pruritus, rektal blødning, analfissur
anal pruritus, rectal haemorrhage, anal fissure
Anal-undersøgelse og underlivsundersøgelse (for kvinder) anbefales før og ved afslutning af behandlingen, eller når det anses for klinisk indiceret.
Anal examinations and pelvic examinations (for women) are recommended before and at the end of treatment or when considered clinically indicated.
analfistel (en lille passage, der dannes mellem endetarmsåbningen og den omgivende hud)
anal fistula (a small channel that forms between the anus and the surrounding skin)
Analfistel Flatulens
Anal fistula Flatulence
Analfistel, pankreatitis
anal fistula, pancreatitis
Analgetika (f.eks. fentanyl, tramadol)
Analgesics (e.g. fentanyl, tramadol)
Analgetika (fx fentanyl, methadon)
Analgesics (e.g. fentanyl, methadone)
Analgetika forbrug*
Analgesic use
Analgetika Pethidin, piroxicam, propoxyphen
Analgesics Pethidine, piroxicam, propoxyphne
Analgetikaforbrug *
Analgesic use
analinfektion
anal infection
analsår
anal sore
Analyse af aktiveret partiel tromboplastintid (APTT)
Activated partial thromboplastin time (aPTT) assay
Analyse af alle dødsårsager viste ingen signifikant forskel mellem prasugrel og clopidogrel i den totale AKS-population (2,76% mod 2,90%), i UA/NSTEMI- populationen (2.58% mod 2.41%) og i STEMI-populationen (3.28% vs 4.31%).
Analysis of all cause death did not show any significant difference between prasugrel and clopidogrel in the All ACS population (2.76% vs 2.90%), in the UA/NSTEMI population (2.58% vs 2.41%), and in the STEMI population (3.28% vs 4.31%).
Analyse af dosislinearitet baseret på AUC antyder, at tenecteplase udviser non-lineær farmakokinetik i det undersøgte dosisinterval, dvs.
The dose linearity analysis based on AUC suggested that tenecteplase exhibits non-linear pharmacokinetics in the dose range studied, i.e.
Analyse af en undergruppe på 36 personer i alderen 6-35 måneder har vist, at 80,6 % havde en firdobbelt stigning af serum-neutraliserende antistofniveau 21 dage efter den første dosis (66,7 % hos 12 personer i alderen 6-11 måneder, 91,7 % hos 12 personer i alderen 12-23 måneder og 83,3 % hos
Analysis of a subset of 36 subjects aged 6 months to 35 months old showed that 80.6 % had a 4 fold increase in serum neutralising antibodies 21 days after the first dose (66.7 % in 12 subjects aged 6 to 11 months old, 91.7 % in 12 subjects aged 12 to 23 months old and 83.3 % in 12 subjects aged 24 to
Analyse af lamina propria mononukleæ re celler udtaget ved biopsi fra den intestinale mucosa viste, at infliximab-behandling forårsagede en reduktion i antallet af celler, som var i stand til at udtrykke TNFα og interferon-γ.
Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferon γ.
Analyse af OS var ikke justeret for den mulige konfunderende effekt ved overkrydsning.
OS analysis was not adjusted for the potentially confounding effects of crossover.
Analyse af primær overlevelse
Primary Survival Analysis
Analyse af resultaterne for overvægtige patienter, der blev behandlet med metformin efter svigt af diæt alene, viste:
Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:
Analyse af resultaterne for overvægtige patienter, der blev behandlet med metformin, efter at diæt alene havde slået fejl, viste:
Analysis of the results for overweight patients treated with metformin after failure of diet alone showed:
Analyse af samlet overlevelse (OS) demonstrerede en statistisk signifikant reduktion på 57 % af risikoen for død for patienter i IMBRUVICA-armen.
Analysis of overall survival (OS) demonstrated a 57% statistically significant reduction in the risk of death for patients in the IMBRUVICA arm.
Analyse af samlet overlevelse viste en signifikant fordel ved R-FC-behandling i forhold til FC- kemoterapi alene (p=0,0319, log-rank test) (tabel 2a).
The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 2a).
Analyse af samlet overlevelse viste fortsat en signifikant fordel ved R-FC-behandling i forhold til FC- kemoterapi (p=0,0319, log-rank test) (tabel 8a).
The analysis of overall survival showed a significant benefit of R-FC treatment over FC chemotherapy alone (p = 0.0319, log-rank test) (Table 8a).
Analyse af sikkerhedsinformation hos 905 perampanelbehandlede ældre personer (i dobbeltblinde studier af ikke- epileptiske indikationer) afslørede ingen aldersrelaterede forskelle i sikkerhedsprofil.
Analysis of safety information in 905 perampanel-treated elderly subjects (in double-blind studies conducted in non-epilepsy indications) revealed no age-related differences in the safety profile.
Analyse af tipranavir-resistens hos tidligere behandlede patienter
Analyses of tipranavir resistance in treatment experienced patients
Analyse af udåndingsprøver og testspecifikationer for laboratorier
Mass spectrometry (IRMS)
Analyse af undergrupper
Subgroup analysis
Analyse baseret på effektpopulationen a, b
Randomised Efficacy Sample a, b
Analyse for OS og PFS blev også udført ved ECOG PS.
Analysis for OS and PFS by ECOG PS was also performed.
Analyse omfatter patienter, der fik knoglemarvstransplantationer i denne periode.
Analysis includes patients receiving BM transplant during this period
Analyse på patienter i klinisk remission i uge 52, som ikke havde responderet i uge 6, men opnåede respons i uge 10 eller uge 14, indikerede, at de kunne få gavn af en dosis vedolizumab i uge 10.
Analyses of Week 52 clinical remission in patients who were non-responders at Week 6 but achieved response at Week 10 or Week 14 indicate that non-responder CD patients may benefit from a dose of vedolizumab at Week 10.
Analyse- model
Analysis model
Analyse- population
Analysis population
analysecertifikatet er markeret som forkastet.
The Certificate of Analysis is marked as rejected.
Analysen (ved dyb sekventering) omfattede NS5A-polymorfismer forbundet med resistens, der gav >2,5 gange ændring i EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T og Y93C/F/H/N/S for genotype 1a HCV-infektion og L31I/F/M/V, P32L, P58D, A92K og Y93C/H/N/S for genotype 1b HCV-infektion).
Analysis (by deep sequencing) included NS5A resistance-associated polymorphisms that conferred > 2.5-fold change in EC50 (K24G/N/R, M 28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, and Y93C/F/H/N/S for genotype 1a and L31I/F/M/V, P32L, P58D, A92K, and Y93C/H/N/S for genotype 1b HCV infection).
Analysen af 13C/12C-forholdet i udåndingsluftens kuldioxid er en integreret del af diagnosticeringssættet Helicobacter Test INFAI til børn I alderen 3 – 11 år.
The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test Helicobacter Test INFAI.
Analysen af 13C/12C-forholdet i udåndingsluftens kuldioxid er en integreret del af diagnosticeringssættet Helicobacter Test INFAI.
The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test Helicobacter Test INFAI.
Analysen af data ved en populationsfarmakokinetisk metode viste ingen forskel på intravenøs busulfan-clearance mellem phenytoin- og clonazepambaseret behandling og derfor blev sammenlignelige busulfan- plasmaeksponeringer opnået uanset typen af krampeprofylakse.
The analysis of data through a population pharmacokinetic method indicated no difference on intravenous busulfan clearance between phenytoin and clonazepam based therapy and therefore similar busulfan plasma exposures were achieved whatever the type of seizure prophylaxis.
Analysen af de samlede resultater fra fase III-studierne understøttede de data, der blev indsamlet i de enkelte studier vedrørende en reduktion i det samlede antal VTE’er, alvorlige VTE’er og symptomatiske VTE’er med 10 mg rivaroxaban én gang dagligt sammenlignet med 40 mg enoxaparin én gang dagligt.
The analysis of the pooled results of the phase III trials corroborated the data obtained in the individual studies regarding reduction of total VTE, major VTE and symptomatic VTE with rivaroxaban 10 mg once daily compared to enoxaparin 40 mg once daily.
Analysen af de samlede resultater fra undersøgelser baseret på Arizona Sexual Experience Scale (ASEX) viste, at Thymanax ikke var forbundet med seksuel dysfunktion.
The pooled analysis of trials using the Arizona Sexual Experience Scale (ASEX) showed that Thymanax was not associated with sexual dysfunction.
Analysen af de samlede resultater fra undersøgelser baseret på Arizona Sexual Experience Scale (ASEX) viste, at Valdoxan ikke var forbundet med seksuel dysfunktion.
The pooled analysis of trials using the Arizona Sexual Experience Scale (ASEX) showed that Valdoxan was not associated with sexual dysfunction.
Analysen af den totale inkluderede population (64 patienter) viste, at størstedelen som minimum forblev stabile (dvs. uden forværring), baseret på en ikke- pædiatrisk-specifik vurdering af WHO-funktionsklasse (97% to gange dagligt, 100% tre gange dagligt) og lægens samlede kliniske vurdering (94% to gange dagligt, 93% tre gange dagligt) i behandlingsperioden.
The analysis on the global population included (64 patients) showed that the majority had remained at least stable (i.e., without deterioration) based on non-paediatric-specific WHO functional class assessment (97% twice daily, 100% three times daily) and physicians’ global clinical impression (94% twice daily, 93% three times daily) during the treatment period.
Analysen af den totale inkluderede population (64 patienter) viste, at størstedelen som minimum forblev stabile (dvs. uden forværring), baseret på en ikke-pædiatrisk-specifik vurdering af WHO-funktionsklasse (97% to gange dagligt, 100% tre gange dagligt) og lægens samlede kliniske vurdering (94% to gange dagligt, 93% tre gange dagligt) i behandlingsperioden.
The analysis on the global population included (64 patients) showed that the majority had remained at least stable (i.e., without deterioration) based on non-paediatric-specific WHO functional class assessment (97% twice daily, 100% three times daily) and physicians’ global clinical impression (94% twice daily, 93% three times daily) during the treatment period.
Analysen af det co-primære virkningsendepunkt, patologisk fuldstændigt respons, defineret som fravær af invasive neoplastiske celler i brystet, resulterede i hyppigheder på 40,7 % (95 % konfidensinterval: 34,7 – 46,9 %) i armen med intravenøst formuleret Herceptin og 45,4 % (95 % konfidensinterval: 39,2-51,7 %) i armen med Herceptin subkutan formulering.
The analysis of the efficacy co-primary endpoint, pCR, defined as absence of invasive neoplastic cells in the breast, resulted in rates of 40.7 % (95 % CI: 34.7, 46.9) in the Herceptin intravenous arm and
Analysen af det co-primære virkningsendepunkt, patologisk fuldstændigt respons, defineret som fravær af invasive neoplastiske celler i brystet, resulterede i hyppigheder på 40,7 % (95 % konfidensinterval: 34,7–46,9 %) i armen med intravenøst formuleret Herceptin og 45,4 % (95 % konfidensinterval: 39,2-51,7 %) i armen med Herceptin subkutan formulering.
The analysis of the efficacy co-primary endpoint, pCR, defined as absence of invasive neoplastic cells in the breast, resulted in rates of 40.7 % (95 % CI: 34.7, 46.9) in the Herceptin intravenous arm and
Analysen af immunogenicitet blev udført på ATP-kohorten for immunogenicitet.
The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for immunogenicity
Analysen af immunogenicitet blev udført på ATP-kohorten for persistens tilpasset til hvert tidspunkt.
The analysis of immunogenicity was conducted on ATP cohort for persistence adapted for each time- point.
Analysen af immunogenicitet blev udført på ATP-kohorterne for immunogenicitet.
The analysis of immunogenicity was conducted on ATP cohorts for immunogenicity.
Analysen af indvirkningen på NSCLC-histologien for total overlevelse viste klinisk relevante forskelle i overlevelse baseret på histologi, se nedenstående tabel.
There were no clinically relevant differences observed for the safety profile of pemetrexed within the histology subgroups.
Analysen af multiple hændelser afslørede en signifikant risikoreduktion på 16 % hos patienter behandlet med zoledronsyre 4 mg sammenlignet med patienter behandlet med pamidronat.
The multiple event analysis revealed a significant risk reduction of 16 % in patients treated with zoledronic acid 4 mg in comparison with patients receiving pamidronate.
Analysen af PFS vurderet af en uafhængig evalueringskomité (censureret for NPT) viser en stratificeret hazard ratio på 0,62 (95 % konfidensinterval: 0,50-0,77, ensidig log-rank p-værdi < 0,0001), når CPB15+ sammenlignes med CPP, med en median PFS på 13,1 måned i CPP-armen og 19,1 måned i CPB15+-armen.
The analysis of PFS as determined by the independent review committee (censoring for NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.50-0.77, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 13.1 in the CPP arm and 19.1 months in the CPB15+ arm.
Analysen af primære og sekundære endepunkter i studiets åben-label fase bekræftede resultaterne fra interimanalysen, som vist i tabellen herunder:
The analyses of primary and secondary endpoints in the open-label phase of the study reaffirmed the results obtained at the time of the interim analysis, as shown in the table below:
Analysen af rPFS benyttede centralt bedømte radiografiske vurderinger af progression.
Analysis of rPFS utilized centrally-reviewed radiographic assessment of progression.
Analysen af samlet overlevelse i den samlede population påviste ikke statistisk signifikans (HR 0,94; 95 % CI: 0,83-1,05).
Overall survival analysis in the overall population did not reach statistical significance (HR 0.94; 95% CI: 0.83 - 1.05).
Analysen af SMPR var tidsjusteret og tog højde for, at en eller flere hændelser opstået i en enkelt 12- ugers periode, kunne være potentielt relateret.
The analysis of the SMPR was time-adjusted and considered that one or more events occurring in a single 12 week period could be potentially related.
Analysen bekræftede, at imatinib-eksponeringen hos børn, som fik 260 mg/m² en gang dagligt (højst 400 mg en gang dagligt) eller 340 mg/m² en gang dagligt (højst 600 mg en gang dagligt), svarede til eksponeringen hos voksne, som fik imatinib 400 mg eller 600 mg en gang dagligt.
The analysis confirmed that exposure of imatinib in paediatric patients receiving 260 mg/m2 once daily (not exceeding 400 mg once daily) or 340 mg/m2 once daily (not exceeding 600 mg once daily) were similar to those in adult patients who received imatinib 400 mg or 600 mg once daily.
Analysen blev udført under anvendelse af en Cox proportional hazards-model med faktorer for behandling, tid til sygdomsprogression ved tidligere næst seneste platinbehandling, objektiv respons på tidligere sidste platinbehandling og jødisk afstamning. b Omkring en fjerdedel af de placebobehandlede patienter i den BRCA-muterede undergruppe (14/62; 22,6 %) fik en efterfølgende PARP-inhibitor.
The analysis was performed using a Cox proportional hazards model with factors for treatment, time to disease progression on prior penultimate platinum therapy, objective response to prior last platinum therapy and Jewish descent. b Approximately a quarter of placebo treated patients in the BRCA-mutated subgroup (14/62; 22.6%) received a subsequent PARP inhibitor.
Analysen for det sekundære endepunkt, relapsfri overlevelse, støtter dissse resultater med en hazard ratio på 0,78 (95 % konfidensinterval = [0,67; 0,92], p = 0,0024) for XELOX versus
The analysis for the secondary endpoint of RFS supports these results with a HR of 0.78 (95% CI=[0.67; 0.92]; p=0.0024) for XELOX vs.
Analysen omfattede 448 skeletrelaterede hændelser, hvoraf 277 (62 %) var strålebehandling af knogler, 95 (21 %) var rygmarvskompression, 47 (10 %) var patologisk knoglefraktur, 36 (8 %) var ændring i antineoplastisk behandling med henblik på behandling af knoglesmerter og 7 (2 %) var knoglekirurgi.
The analysis involved 448 skeletal-related events, of which 277 events (62%) were radiation to bone, 95 events (21%) were spinal cord compression, 47 events (10%) were pathologic bone fracture, 36 events (8%) were change in antineoplastic therapy to treat bone pain and 7 events (2%) were surgery to bone.
Analysen omfattede kun forsøgspersoner, der blev randomiseret til behandling, fik mindst én injektion, havde en baseline-værdi og mindst én effektvurdering post-baseline. b Forskellen (Abilify Maintena minus placebo) i middelændring fra baseline beregnet ved mindste kvadraters metode.
The analysis included only subjects who were randomly assigned to treatment, given at least one injection, had baseline and at least one post-baseline efficacy assessment. b Difference (Abilify Maintena minus placebo) in least squares mean change from baseline.
Analysen påviste forbedret ORR (CR+PR) (odds-ratio 3,769; 95 % CI 2,045-6,947; p < 0,001), PFS (hazard ratio 0,511; 95 % CI
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511;
Analysen påviste forbedret ORR (CR+PR) (oddsratio 3,769; 95 % CI 2,045-6,947; p < 0,001), PFS (hazard-ratio 0,511; 95 % CI
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511;
Analysen var designet til at identificere BRAF V600E- og V600K-mutationerne med høj sensitivitet (ned til 5 % V600E- og V600K-sekvens i en baggrund af vildtypesekvens ved brug af DNA ekstraheret fra FFPE-væv).
The assay was designed to detect the BRAF V600E and V600K mutations with high sensitivity (down to 5% V600E and V600K sequence in a background of wild- type sequence using DNA extracted from FFPE tissue).
Analysen var specifikt designet til at kunne skelne mellem V600E- og V600K- mutationerne.
The assay was specifically designed to differentiate between the V600E and V600K mutations.
Analysen var stratificeret i forhold til brug af enzyminducerende antiepileptika (EIAEDer) ved randomiseringen (ja/nej).
The analysis was stratified by use of enzyme-inducing antiepileptic drugs (EIAEDs) at randomisation (yes/no).
Analysen var stratificeret vha. enzyminducerende antiepileptika (EIAEDer) ved randomiseringen (ja/nej).
The analysis was stratified by use of enzyme-inducing antiepileptic drugs (EIAEDs) at randomisation (yes/no).
Analysenaf PFS var baseret på evaluering af en IRC.
The analysis of PFS was based on evaluation by an IRC.
Analysepræstationen af NovoEight i FVIII:C undersøgelsen blev evalueret og sammenlignet med et markedsført fuld længde rekombinant FVIII produkt i et internationalt studie omfattende 36 laboratorier.
In an international study involving 36 laboratories, the assay performance of NovoEight in FVIII:C assays was evaluated and compared to a marketed full length recombinant FVIII product.
Analyser af data fra kliniske studier viste ikke evidens for øget risiko for svære neuropsykiatriske hændelser med vareniclin sammenlignet med placebo.
Analyses of clinical trial data did not show evidence of an increased risk of serious neuropsychiatric events with varenicline compared to placebo.
Analyser af den estimerede absorberede strålingsdosis blev udført ved brug af kvantitativ scanning med gamma-emitter [111In] radioaktivt mærket Zevalin, blodprøveudtagning og MIRDOSE3 software-programmet.
Analyses of estimated radiation absorbed dose were carried out using quantitative imaging with the gamma-emitter [111In]-radiolabelled Zevalin, blood sampling, and the MIRDOSE3 software program.
Analyser af gentagne hændelser viste en risikoreduktion på 36 % i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mg-gruppen sammenlignet med placebo.
Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Analyser af gentagne hændelser viste risikoreduktion på 30,7 % i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mg- gruppen sammenlignet med placebo.
Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Analyser af gentagne hændelser viste risikoreduktion på 30,7% i udviklingen af skeletrelaterede hændelser i zoledronsyre 4 mg- gruppen sammenlignet med placebo.
Multiple event analysis showed 30.7% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.