FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 to 2 implantation matrices
Danish: 1 til 2 implantationsmatricer
English: Dish cells/cm²
Danish: Skål celler/cm²
English: EU (MA) number (Invented)
Danish: MF (EU)-nummer
English: In general, it can be concluded that the safety profile seems well characterized.
Danish: Det kan generelt konkluderes, at sikkerhedsprofilen er godt karakteriseret.
English: Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the variation of the marketing authorisations.
Danish: I henhold til artikel 116 i direktiv 2001/83/EF anbefaler udvalget derfor ændring af markedsføringstilladelserne.
English: Furthermore, residual bias will always be present.
Danish: Desuden vil der altid være resterende bias.
English: Only a limited amount of parameters in these retrospective analyses were available.
Danish: Der var kun et begrænset antal parametre tilgængelige i disse retrospektive analyser.
English: These results should, however, be interpreted with caution.
Danish: Disse resultater bør dog fortolkes med forsigtighed.
English: The statistical analysis and interpretation were not robust according to current standards.
Danish: Den statistiske analyse og fortolkningen var ikke robust ifølge gængse standarder.
English: Both submissions discussed the available data sources and their interpretation.
Danish: I begge anmodninger drøftes de tilgængelige datakilder og fortolkningen heraf.
English: These products contain 18 to 22 carbon atoms and a varying number of double bonds, the first of which is in the n-3 position.
Danish: Disse produkter indeholder 18-22 kulstofatomer og et forskelligt antal dobbeltbindinger, hvor den første er i position n-3.
English: It should also be noted that the current European guidelines no longer recommend omega-3 supplementation in this indication.
Danish: Det bør også bemærkes, at de aktuelle europæiske retningslinjer ikke længere anbefaler omega-3tilskud i denne indikation.
English: With respect to safety, the PRAC concluded in the last PSUSA (January 2017) that no new safety issues had emerged.
Danish: Hvad angår sikkerhed, konkluderede PRAC i den seneste PSUSA (januar 2017), at der ikke var fundet nye sikkerhedsproblemer.
English: It has also been argued that the OMEGA trial had a too short duration (12 months) to observe beneficial effects.
Danish: Der har også været argumenteret for, at OMEGA-studiet havde en for kort varighed (12 måneder) til at observere gavnlige virkninger.
English: The narrow confidence interval excludes any clinically relevant beneficial effects.
Danish: Det snævre konfidensinterval udelukker enhver klinisk relevant gavnlig effekt.
English: Therefore, it is considered that these studies are only supportive.
Danish: Derfor anses disse studier kun for at være understøttende.
English: The recommendations in these guidelines are therefore developed after careful consideration of the scientific and medical knowledge and evidence available at the time of coming into effect.
Danish: Anbefalingerne i disse retningslinjer er således udarbejdet efter omhyggelig inddragelse af den videnskabelige og lægefaglige viden og den tilgængelige evidens på tidspunktet for ikrafttrædelse.
English: Based on the results, there is only a 2.5% chance that the relative risk reduction for MACE exceeds 4%.
Danish: Baseret på resultaterne er der kun 2,5 % sandsynlighed for, at den relative risikoreduktion for MACE overstiger
English: Since this was not the case, these can be considered supportive for a lack of efficacy.
Danish: Da det ikke var tilfældet, kan resultaterne anses for at understøtte en manglende virkning.
English: With any other interpretation about the primary endpoints, multiplicity should have been controlled, which was not the case.
Danish: Ved enhver anden fortolkning af det primære endepunkt ville der være gennemført multiplicitetskontrol, hvilket ikke er sket her.
English: Although statin use increased during the study, it was only 28 - 29% at 6 months and 44 - 46% at 42 months.
Danish: Selvom forbruget af statiner steg i løbet af studiet, sås anvendelse af statiner kun hos 28-29 % efter 6 måneder og 44-46 % efter 42 måneder.
English: It is considered that the study had co-primary endpoints and hierarchical primary and secondary endpoint analyses.
Danish: Det vurderes, at studiet havde co-primære endepunkter og hierarkiske primære og sekundære effektanalyser.
English: The study formally failed because the primary analysis of one of the coprimary endpoints did not show a statistically significant difference.
Danish: Studiet har fejlet formelt, fordi den primære analyse af et af de co-primære endepunkter ikke viste en statistisk signifikant forskel.
English: They noted that this treatment is not recommended in the current guidelines for prevention of CVD by the European Society of Cardiology and the European Atherosclerosis Society.
Danish: De bemærkede, at sådan behandling ikke anbefales i de gældende retningslinjer for forebyggelse af kardiovaskulære sygdomme fra det europæiske hjerteselskab (European Society of Cardiology) og den europæiske aterosklerose-forening (European Atherosclerosis Society).
English: However, in the GISSI-P trial, the effect was most pronounced at earlier time points (<12 months) with no increase thereafter.
Danish: I GISSI-P-studiet var virkningen dog mest udtalt på tidlige tidspunkter (< 12 måneder) uden nogen efterfølgende stigning.
English: However, later studies, including meta-analyses1,2,3 have failed to show a beneficial effect in this condition.
Danish: I senere studier, herunder metaanalyser1,2,3 , er det imidlertid ikke lykkedes at påvise en gavnlig virkning ved denne tilstand.
English: OMEGA trial was based on a more robust and adequate design than GISSI-P.
Danish: OMEGA-studiet var baseret på et mere robust og hensigtsmæssigt design end GISSI-P.
English: Thus, retrospective data in these studies did not allow for appropriate statistical adjustment for confounding.
Danish: Retrospektive data fra disse studier tillod derfor ikke at foretage en hensigtsmæssig statistisk tilpasning for forstyrrende faktorer.
English: Therefore, the proposed modification of the indication is not acceptable by the CHMP.
Danish: Derfor kan CHMP ikke acceptere den ansøgte ændring af indikationen.
English: Additionally, the level of evidence in these post-hoc subgroup analyses is not strong.
Danish: Desuden er evidensen i disse post hoc-delgruppeanalyser ikke stærk.
English: The efficacy in this indication was not demonstrated in subsequent and more robust clinical trials.
Danish: Virkningen i denne indikation blev ikke påvist i efterfølgende, mere robuste kliniske studier.
English: Therefore, at the most about 1/3 of the 11,324 randomized patients received appropriate baseline medication at any time during the first year and not more than 5% over the entire first year.
Danish: Det var således højst ca. en tredjedel af de 11.324 randomiserede patienter, der fik relevante baselinelægemidler på et tidspunkt i løbet af det første år, og ikke mere end 5 % fik det i hele det første år.
English: Propensity score matching was incomplete or even not attempted.
Danish: Matchning af tendensscorer var ikke fyldestgørende eller slet ikke forsøgt.
English: Another concern for this study was its open-label design and that the control group did not receive placebo treatment.
Danish: En anden betænkelighed ved dette studie er det åbne design og det faktum, at kontrolgruppen ikke fik nogen placebo-behandling.
English: This study suffers from some methodological limitations and results should be interpreted with caution.
Danish: Studiet har en række metodemæssige begrænsninger, og resultaterne bør derfor fortolkes med forsigtighed.
English: Furthermore, ischaemic stroke is also most often caused by atherosclerosis.
Danish: Iskæmisk slagtilfælde er også oftest forårsaget af aterosklerose.
English: It did not reproduce these findings and did not demonstrate efficacy in this indication.
Danish: Det kunne ikke genskabe disse fund og påviste ikke nogen virkning i denne indikation.
English: Especially selection bias is of concern, as it can be envisaged that omega-3 fatty acids will be prescribed to certain patients (not needing strict treatment immediately).
Danish: Navnlig er udvælgelsesbias bekymrende, da det kan forventes, at omega-3-fedtsyrer vil blive ordineret til visse patienter (der ikke har brug for fuld behandling med det samme).
English: Based on these limitations, the results of the cohort studies are not considered to override the results of the randomized trials referred to above.
Danish: Som følge af disse begrænsninger anses resultaterne af kohortestudierne ikke for at tilsidesætte resultaterne af ovennævnte randomiserede studier.
English: In addition, less than 5% of the patients included in this study received optimal baseline therapy over the whole study period which questions the results in the context of current secondary therapy recommendations.
Danish: Derudover fik færre end 5 % af patienterne i studiet optimal baseline-behandling i hele studieperioden, hvilket sår tvivl om resultaterne, hvad angår de aktuelle anbefalinger i forbindelse med sekundær forebyggelse.
English: ESC/EAS guidelines are recommendations made by various societies in consultation with task forces, expert groups or consensus panels, with the aim of assisting physicians in selecting the best management strategies for an individual patient with a given condition taking into account the impact on outcome as well as the risk/benefit ratio of particular diagnostic or therapeutic means.
Danish: Retningslinjerne fra ESC/EAS er anbefalinger, der er udarbejdet af en række foreninger i samråd med arbejdsgrupper, ekspertgrupper eller konsensuspaneler med henblik på at hjælpe læger med at vælge de bedste behandlingsstrategier til de enkelte patienter med en given sygdom under hensyn til indvirkningen på udfaldet samt benefit/risk-forholdet for specifikke diagnostiske eller terapeutiske midler.
English: In GISSI-P at the most, 5% of the patients received lipid lowering therapy over the whole period of the first year.
Danish: I GISSI-P fik højst 5 % af patienterne lipidsænkende behandling i hele det første år.
English: Similar to OMEGA trial, a lack of effect of in this indication was observed.
Danish: Ligesom i OMEGA-studiet blev der observeret en mangel på virkning i denne indikation.
English: Grounds for re-examination have been submitted by BASF AF and ALFASIGMA S.p.A, representing eleven MAHs.
Danish: Begrundelserne for revurdering er indsendt af BASF AF og ALFASIGMA S.p.A, som repræsenterer 11 indehavere af markedsføringstilladelse.
English: Two of the studies (Greene5 and Macchia6) included a large number of subjects and for the latter, the documented risk reduction for all-cause mortality was 37% (RR 0.63 CI 0.56-0.72).
Danish: To af studierne (Greene5 og Macchia6) omfattede et stort antal forsøgspersoner, og for sidstnævntes vedkommende var den dokumenterede risikoreduktion for død uanset årsag 37 % (RR 0,63, KI 0,56-0,72).
English: The study is associated with some methodological limitations - this was an open label study where the control group did not receive study medication which may have influenced the results.
Danish: Studiet er forbundet med visse metodemæssige begrænsninger, idet det var et åbent studie, hvor kontrolgruppen ikke fik forsøgslægemidlet, hvilket kan have påvirket resultaterne.
English: The original approval of Omacor (EU reference medicinal product) was based on an open-label study (GISSI-P) from 1999.
Danish: Den oprindelige godkendelse af Omacor (referencelægemiddel i EU) var baseret på et åbent studie (GISSI-P) fra 1999.
English: Beta-blockers that are indicated in most patients post MI were only used in 37 - 44% in GISSI-P.
Danish: Betablokkere, der er indiceret hos de fleste patienter efter hjerteinfarkt, blev kun brugt af 37-44 % i GISSI-P.
English: Studies in patients with an implantable cardioverter defibrillator (ICD) showed inconsistent results regarding antiarrhythmic efficacy (Leaf et al.8, 2005; Brouwer et al.9 2006, Raitt et al.10, 2005; Weisman et al.11, 2017).
Danish: Studier af patienter med en implanterbar defibrillator (ICD) viste inkonsistente resultater vedrørende antiarytmisk effekt (Leaf et al.8, 2005; Brouwer et al.9, 2006, Raitt et al.10, 2005; Weisman et al.11, 2017).
English: Furthermore, although this post-hoc analysis did not show differences in benefit with or without concomitant statin therapy, potential differences could not be excluded since the study was underpowered for demonstrating such differences.
Danish: Derudover skal det bemærkes, at selvom disse post hoc-analyser ikke viste fordelsmæssige forskelle med og uden samtidig statin-behandling, kan potentielle forskelle ikke udelukkes, da studiet ikke havde styrke til at påvise sådanne forskelle.
English: actually reflect biologically plausible effects or more likely reflect a selection bias problem.
Danish: Nogle af resultaterne sår tvivl om, hvorvidt de observerede forbindelser rent faktisk afspejler biologisk plausible virkninger eller måske snarere afspejler et problem med udvælgelsesbias.
English: Regarding the OMEGA study, the CHMP considered that although the trial could be considered to be underpowered this does not invalidate the study results entirely, in line with SAG on 19 March 2019.
Danish: Med hensyn til OMEGA-studiet vurderer CHMP, at selvom studiet kan anses for ikke at have tilstrækkelig styrke, kan det ikke ugyldiggøre studiets resultater fuldstændigt, jf. den videnskabelige rådgivende gruppes møde den 19. marts 2019.
English: This potential positive effect on mortality has not been reproduced in subsequent trials and the antiarrhythmic effect has not been confirmed in trials examining patients with ICD.
Danish: Denne mulige positive virkning på dødelighed har ikke kunnet genskabes i efterfølgende studier, og den antiarytmiske virkning er ikke blevet bekræftet i studier af patienter med implanterbar defibrillator (ICD).
English: • It has been hypothesised that the results of the GISSI-P trial was driven by a reduced risk of sudden death, potentially based on an antiarrhythmic effect of omega-3.
Danish: • Der har været fremsat en hypotese om, at resultaterne af GISSI-P-studiet var drevet af en reduceret risiko for pludselig død, muligvis på grund af en antiarytmisk virkning ved omega-3.
English: They also inhibit very-low-density lipoprotein (VLDL) synthesis in the liver, which reduces triglyceride concentrations.
Danish: De hæmmer også VLDL (very lowdensity lipoprotein)-syntesen i leveren, hvormed triglyceridkoncentrationen reduceres.
English: If there was a relevant beneficial antiarrhythmic effect of omega-3 acid ethyl esters, as has been stated, it should also have been relevant for those patient populations at increased cardiovascular risk included in these studies.
Danish: Hvis der var en relevant, gavnlig, antiarytmisk virkning af omega-3-syreethylestere, som det er blevet anført, burde den også have været relevant for de patientpopulationer med forhøjet kardiovaskulær risiko, som var inkluderet i disse studier.
English: The OMEGA study included close to 2000 patients in both arms and over 300 MACE events were reported, more in the omega-3 group than in the placebo group OR 1.25 (0.96-1.52).
Danish: OMEGA-studiet omfattede ca. 2.000 patienter i de to behandlingsgrupper, og der blev rapporteret om over 300 MACE-hændelser, flere i omega-3-gruppen end i placebo-gruppen (OR 1,25 (0,96-1,52)).
English: The experts agreed that there is no sign of harm in the totality of data, but that the beneficial effect of omega-3s may be questioned.
Danish: Eksperterne var enige om, at der ikke er fundet evidens for skade i de samlede data, men at den gavnlige effekt af omega-3-fedtsyrer kan diskuteres.
English: Total mortality was also numerically higher in the omega-3 fatty acids group OR 1.25 (0.90-1.72).
Danish: Den samlede dødelighed var også numerisk højere i den gruppe, der fik omega-3-fedtsyrer (OR 1,25 (0,90-1,72)).
English: They are essential fatty acids and must be obtained from the diet.
Danish: Der er tale om essentielle fedtsyrer, der skal indtages gennem kosten.
English: These limitations include the open-label study design with no study medication in the control arm, the small magnitude of effect, the unusual and unexpected observation of an effect on fatal cardiovascular events only in the absence of any effect on non-fatal events and poor precision of the results.
Danish: Disse begrænsninger omfatter det åbne studiedesign uden forsøgslægemiddel i kontrolgruppen, effektens beskedne omfang, den usædvanlige og uventede observation af en virkning, hvad angår fatale kardiovaskulære hændelser alene, og manglende effekt ved ikkefatale hændelser samt den ringe præcision af resultaterne.
English: No attempts have been made to adjust for likely differences between centers regarding strategies and ambition for secondary prevention, likely creating correlations within centers.
Danish: mellem centrene med hensyn til strategier og ambition for sekundær forebyggelse, hvilket sandsynligvis skaber korrelationer inden for det enkelte center.
English: Vitamin E is not considered beneficial in the prophylaxis of cardiovascular events.
Danish: E-vitamin anses ikke som gavnligt ved forebyggelse af kardiovaskulære hændelser.
English: Therefore omega-3 fatty acids are also termed n-3 polyunsaturated fatty acids (n-3 PUFA).
Danish: Derfor kaldes omega-3-fedtsyrer også n-3-flerumættede fedtsyrer (n-3PUFA).
English: • The OMEGA trial (performed in 2010 after the original approval of the secondary prevention indication) was a well performed, double blind trial evaluating a population well representative of the currently approved secondary prevention indication, including the use of standard of care treatment.
Danish: • OMEGA-studiet (der blev gennemført i 2010 efter den oprindelige godkendelse af indikationen sekundær forebyggelse) var et veludført, dobbeltblindet studie til undersøgelse af en population, der var meget repræsentativ for den aktuelt godkendte indikation sekundær forebyggelse, herunder brug af standardbehandling.
English: • The CHMP considered that, even though it is acknowledged that the GISSI-P clinical trial was the basis for the original approval of the secondary prevention indication in the light of more recent data and information, the study is considered to have some serious limitations that cast doubts on the results.
Danish: • CHMP konkluderede, at selvom det anerkendes, at det kliniske GISSI-P-studie var grundlaget for den oprindelige godkendelse af indikationen sekundær forebyggelse, må studiet i lyset af de nyere data og oplysninger anses for at have en række alvorlige begrænsninger, der sår tvivl om resultaterne.
English: The MAHs citation of relevant guideline "included clinical trials need to be longterm controlled (usually 12 months or longer), parallel and preferably double-blind" is correct.
Danish: Markedsføringstilladelsesindehavernes henvisning til relevant retningslinje "herunder kliniske studiers behov for at være langvarige, kontrollerede (typisk 12 måneder eller længere), parallelle og gerne dobbeltblindede" er korrekt.
English: In particular the GISSI-P and OMEGA trials, which were considered most relevant, have been extensively discussed by the MAHs.
Danish: Navnlig studierne GISSI-P og OMEGA, der blev anset for at være de mest relevante, er blevet grundigt drøftet af indehaverne af markedsføringstilladelse.
English: Moreover, the American Heart Association states that use of omega-3 fatty acid supplements is ‘reasonable' for patients with prevalent coronary heart disease such as MI, indication that strength of recommendation is therefore low (Class IIa/IIb Recommendation).
Danish: Desuden anfører den amerikanske hjerteforening (American Heart Association), at brug af omega-3-fedtsyretilskud er "fornuftigt" for patienter med prævalent koronar hjertesygdom som f.eks. hjerteinfarkt, hvilket indikerer, at anbefalingens styrke er lav (klasse IIa/IIb-anbefaling).
English: All these studies carry the risk of a selection bias, which is supported by baseline data provided, e.g. in the retrospective cohort study by Polle (2013)7 only 1 % of post MI patients who were screened were included in the analysis.
Danish: Alle disse studier har en indbygget risiko for udvælgelsesbias, som understøttes af de fremlagte baseline-data; f.eks. blev kun 1 % af de screenede patienter i det retrospektive kohortestudie (Polle, 2013)7, der havde haft et hjerteinfarkt, medtaget i analysen.
English: These were not rich enough to allow for a full adjustment of differences in risk profiles or to mirror real life post MI situations (e.g. no data regarding smoking history, BMI/obesity, physical exercise were reported in the Macchia study).
Danish: Dette var ikke nok til at tillade en fuld justering for forskelle i risikoprofiler eller afspejle situationer fra det virkelige liv efter et hjerteinfarkt (f.eks. var der ingen data for rygehistorie, BMI/fedme og fysisk aktivitet i Macchia-studiet).
English: This included the responses submitted by the marketing authorisation holders in writing and during an Oral Explanation, as well as the outcome of the consultation with the Cardiovascular Scientific Advisory Group on the 10 of October 2018.
Danish: De omfattede blandt andet de svar, som indehaverne af markedsføringstilladelse havde fremsendt på skrift og afgivet mundtligt under en høring, samt udfaldet af samrådet med den videnskabelige rådgivende gruppe vedrørende kardiovaskulære sygdomme den 10. oktober
English: The latter concern also applies to post-hoc analyses in patients with or without anti-platelet medicinal products, betablockers or ACE-inhibitors.
Danish: Sidstnævnte problem gælder også post hoc-analyser hos patienter med og uden trombocythæmmende midler, betablokkere eller ACE-hæmmere.
English: Even though the incidence of sudden death may have been too low to draw firm conclusions, the OR for MACE and total mortality was above 1.21 and 1.25 respectively with lower CI close to 1 not supporting an effect in the approved indication.
Danish: Selvom incidensen af pludselig død kan have været for lav til at drage endelige konklusioner, var OR for MACE og samlet dødelighed over hhv. 1,21 og 1,25 med et lavere KI tæt på 1, som ikke understøttede en virkning i den godkendte indikation.
English: However, ignoring double blind by using no treatment as comparator (as in GISSI-P) ignores another important concept in clinical trials, i.e. the use of a (blinded) comparator in order to control the other effects than the investigational drug, and deviation of this principle should only be needed or suitable "when it is difficult or impossible to avoid" (ICH E10 guideline on Choice of control group in clinical trials).
Danish: Ved at tilsidesætte dobbeltblinding og ikke gøre brug af en komparatorbehandling (som det er tilfældet i GISSI-P) tilsidesætter man imidlertid et andet vigtigt aspekt af kliniske studier, nemlig brug af en (blindet) komparator med henblik på at undersøge andre virkninger end forsøgslægemidlets effekt; en afvigelse fra dette princip bør kun anses som nødvendig eller acceptabel, "når den er vanskelig eller umulig at undgå" (ICH E10-retningslinjen om valg af kontrolgruppe i kliniske forsøg).
English: Following the adoption of the CHMP opinion in December 2018, a re-examination request was received from the MAHs involved in the procedure, BASF AS (representing Mylan Hrvatska D.O.O, BGP Products Ltd, Ferrer-Galenica S.A and Strides Arcolab International Limited) and ALFASIGMA S.p.A (on behalf of DOC GENERICI S.r.l., EG S.p.A., IBSA FARMACEUTICI ITALIA S.r.l., PFIZER ITALIA S.r.l., SPA SOCIETÀ PRODOTTI ANTIBIOTICI S.p.A.).
Danish: Efter vedtagelse af CHMP's udtalelse i december 2018 blev der indsendt en anmodning om revurdering fra de berørte indehavere af markedsføringstilladelse, nemlig BASF AS (som repræsentant for Mylan Hrvatska D.O.O, BGP Products Ltd, Ferrer-Galenica S.A og Strides Arcolab International Limited) og ALFASIGMA S.p.A (på vegne af DOC GENERICI S.r.l., EG S.p.A., IBSA FARMACEUTICI ITALIA S.r.l., PFIZER ITALIA S.r.l.