FrancophonIA/ELRC3.0 huggingface dataset:
English: Ciprofloxacine Mylan Ciprofloxacin 500mg Tablet
Danish: Ciprofloxacine Mylan Ciprofloxacin 500 mg i tabletform
English: Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Danish: Ciprofloxacina Sandoz Ciprofloxacinhydrochloridmon ohydrat 500 mg i tabletform
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 512.46mg Tablet
Danish: Levofloxacine Pch Levofloxacinhemihydrat 512,46 mg i tabletform
English: Levofloxacin Macleods Levofloxacin Hemihydrate 256.23mg Tablet
Danish: Macleods Pharma Uk Ltd Levofloxacin Macleods Levofloxacinhemihydrat 256,23 mg i tabletform
English: Levofloxacine Sandoz Levofloxacin 500mg Tablet
Danish: Levofloxacine Sandoz Levofloxacin 500 mg i tabletform
English: Moxifloxacin Mylan Moxifloxacin 400mg Tablet
Danish: Moxifloxacin Mylan Moxifloxacin 400 mg i tabletform
English: Levofloxacin Mylan Levofloxacin 500mg Tablet
Danish: Levofloxacin Mylan Levofloxacin 500 mg i tabletform
English: Moxifloxacine Sandoz Moxifloxacin 400mg Tablet
Danish: Moxifloxacine Sandoz Moxifloxacin 400 mg i tabletform
English: Ciprofloxacín Sandoz Ciprofloxacin 500mg Tablet
Danish: Ciprofloxacín Sandoz Ciprofloxacin 500 mg i tabletform
English: Levofloxacina Generis Levofloxacin Hemihydrate 512.46mg Tablet
Danish: Levofloxacino Combix Levofloxacinhemihydrat 512,46 mg i tabletform
English: Ciprofloxacine Sandoz Ciprofloxacin 500mg Tablet
Danish: Ciprofloxacine Sandoz Ciprofloxacin 500 mg i tabletform
English: Moxifloxacine Mylan Moxifloxacin 400mg Tablet
Danish: Moxifloxacine Mylan Moxifloxacin 400 mg i tabletform
English: Ranbaxy Pharmacie Generiques Ciprofloxacine Ranbaxy Ciprofloxacin 250mg Tablet
Danish: Axcount Generika Gmbh Ciprofloxacin Axcount Ciprofloxacin 250 mg i tabletform
English: Levofloxacin Sandoz Levofloxacin 500mg Tablet
Danish: Levofloxacin Sandoz Levofloxacin 500 mg i tabletform
English: Ciprofloxacín Sandoz Ciprofloxacin 250mg Tablet
Danish: Ciprofloxacín Sandoz Ciprofloxacin 250 mg i tabletform
English: Ranbaxy Pharmacie Generiques Ofloxacine Ranbaxy Ofloxacin 200mg Tablet
Danish: Ofloxacine Ranbaxy Ofloxacin 200 mg i tabletform Filmovertrukket tablet Til oral anvendelse
English: Ciprofloxacine Sandoz Ciprofloxacin 250mg Tablet
Danish: Ciprofloxacine Sandoz Ciprofloxacin 250 mg i tabletform
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 873mg Tablet
Danish: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacinhydrochlorid 873 mg i tabletform
English: Ciprofloxacin Sandoz Ciprofloxacin 500mg Tablet
Danish: Ciprofloxacin Sandoz Ciprofloxacin 500 mg i tabletform
English: Moxifloxacin Sandoz Moxifloxacin 400mg Tablet
Danish: Moxifloxacin Sandoz Moxifloxacin 400 mg i tabletform
English: Levofloxacin Sandoz Levofloxacin 250mg Tablet
Danish: Levofloxacin Sandoz Levofloxacin 250 mg i tabletform
English: Ranbaxy Pharmacie Generiques Levofloxacine Ranbaxy Levofloxacin 500mg Tablet
Danish: Levofloxacine Ranbaxy Levofloxacin 500 mg i tabletform
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 582mg Tablet
Danish: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacinhydrochlorid 582 mg i tabletform
English: All animals should have had water from the same source
Danish: Alle dyr skal have fået vand fra samme kilde.
English: Fatalities are extremely rare.
Danish: Dødsfald er ekstremt sjældne.
English: Therefore this statement is not maintained.
Danish: Derfor opretholdes denne erklæring ikke.
English: The authors could not provide a sound explanation for this.
Danish: Forfatterne kunne ikke give en god forklaring på dette.
English: Other safety aspects
Danish: Andre sikkerhedsaspekter
English: These effects might be delayed and subtle.
Danish: Disse effekter kan være forsinket og subtile.
English: Neither would the introduction of educational material address this issue.
Danish: Og indførelsen af undervisningsmateriale vil heller ikke løse dette problem.
English: In case such studies were however to be carried out, patients would bear the risks as long as ongoing research is not completed.
Danish: Men hvis sådanne undersøgelser skulle udføres, ville patienterne bære risikoen, så længe den igangværende forskning ikke er afsluttet.
English: Particularly, it was stated that the influence on patient management was not directly demonstrated by the study results.
Danish: Især blev det anført, at indflydelsen på patientadministrationen ikke var direkte påvist af undersøgelsens resultater.
English: In addition, the repeated use of these products is most unlikely.
Danish: Derudover er gentagen brug af disse lægemidler meget usandsynlig.
English: This clearly indicates that potential dechelation in the body is a recognised phenomenon.
Danish: Dette indikerer klart, at potentiel dechelatering i kroppen er et anerkendt fænomen.
English: Whereas
Danish: Hvor
English: Such long-term safety studies are unlikely to be feasible within reasonable period of time.
Danish: Det er ikke sandsynligt, at sådanne langsigtede sikkerhedsundersøgelser er mulige inden for rimelig tid.
English: Detailed conclusions from the meeting can be found in the enclosure 11 to the PRAC assessment report.
Danish: Detaljerede konklusioner fra mødet kan findes i bilag 11 til PRAC's vurderingsrapport.
English: Higher relaxivity of Multihance
Danish: Højere relaksivitet af MultiHance
English: Premedication with antihistamines and corticosteroids could also be applied.
Danish: Præmedicinering med antihistaminer og kortikosteroider kan også anvendes.
English: The experts at the ad-hoc expert meeting shared these same views.
Danish: Eksperterne på ad hocekspertmødet delte de samme synspunkter.
English: The linear compounds therefore particularly persist in the brain.
Danish: De lineære forbindelser persisterer derfor især i hjernen.
English: Organ-specific indication for Omniscan
Danish: Organspecifik indikation for Omniscan
English: • The practical implementation of these measures is moreover not deemed feasible in a clinical setting.
Danish: • Den praktiske gennemførelse af disse foranstaltninger anses i øvrigt ikke for mulig i et klinisk miljø.
English: Nephrogenic systemic fibrosis (NSF)
Danish: Nefrogen systemisk fibrose (NSF)
English: In accordance with Article 107k of Directive 2001/83/EC, the CHMP considered the PRAC recommendation adopted on 6 July 2017.
Danish: I overensstemmelse med artikel 107k i direktiv 2001/83/EF behandlede CHMP PRAC's anbefaling vedtaget den 6. juli 2017.
English: All GdCAs have some degree of renal elimination, which varies from 50% for gadoxetic acid to 100% for most other members of the class.
Danish: Alle GdCA'er har en vis grad af renal eliminering, som varierer fra 50% for gadoxinsyre til 100% for de fleste andre medlemmer af klassen.
English: The vast majority of these reactions are non-serious, with a very low percentage of patients experiencing severe hypersensitivity reactions.
Danish: Langt de fleste af disse reaktioner er ikke alvorlige, med en meget lav procentdel af patienter der oplever alvorlige hypersensitivitetsreaktioner.
English: Additionally, it is not possible to define a period of time during which no potential adverse effect would have time to manifest.
Danish: Desuden er det ikke muligt at definere en periode, hvor ingen potentiel bivirkning ikke vil have tid til at manifestere sig.
English: It is not fully clear how reliable the method of Gd quantification in tissue was.
Danish: Det er ikke helt klart, hvor pålidelig metoden til Gd-kvantificering i væv var.
English: Despite worldwide use serious adverse reactions are rare; urticaria is the most common manifestation.
Danish: Trods global brug er alvorlige bivirkninger sjældne; urticaria er den mest almindelige manifestation.
English: Skin prick testing could facilitate the identification of an alternative GdCA.
Danish: Hudpriktest kunne lette identifikationen af en alternativ GDCA.
English: In general, appropriate medications, equipment and staff experienced in the management of hypersensitivity reactions can be expected in any radiological practice.
Danish: Generelt kan passende medicin, udstyr og personale med erfaring i behandling af hypersensitivitetsreaktioner forventes i enhver radiologisk praksis.
English: Population-specific indication for Multihance
Danish: Population-specifik indikation for MultiHance
English: Thus, PRAC considered that the McDonald study did not change their previous conclusions and noted that this view is also supported by the ad-hoc expert group held on the 19th of June.
Danish: PRAC mente således, at McDonald-undersøgelsen ikke ændrede deres tidligere konklusioner og bemærkede, at denne opfattelse også støttes af ad hoc-ekspertgruppen afholdt den 19. juni.
English: The implemented risk minimisation measures appear to be effective based on annual reviews of spontaneous case reports.
Danish: De implementerede risikominimeringsforanstaltninger synes at være effektive ud fra årlige gennemgange af spontane sagsrapporter.
English: However, it demonstrates the complexity and difficulties associated with the objective of analysing potential neurological effects.
Danish: Men det viser kompleksiteten og de vanskeligheder, der er forbundet med at analysere potentielle neurologiske virkninger.
English: This dissociation is believed to be related to differences in the stability of the complexes among the various types of GdCAs (Spencer et al. 1997).
Danish: Denne dissociation antages at være relateret til forskelle i kompleksernes stabilitet blandt de forskellige typer GdCA'er (Spencer et al. 1997).
English: In view of the above, the PRAC concluded that:
Danish: På baggrund af ovenstående konkluderede PRAC, at:
English: Gadolinium-associated plaques
Danish: Gadolinium-associerede plaques
English: It should be noted that McDonald et al. (2017) reported very little Gd deposition.
Danish: Det bør noteres, at McDonald et al. (2017) rapporterede om meget lille Gd-aflejring.
English: Data from the clinical post-mortem studies are heterogeneous and it is therefore difficult to compare the levels.
Danish: Data fra de kliniske post mortem-undersøgelser er heterogene, og det er derfor vanskeligt at sammenligne niveauerne.
English: Although in patients with a history of drug allergy the reaction risk might be increased, the risk is still very low.
Danish: Selv om der kan være øget reaktionsrisiko hos patienter med tidligere medicinallergi, er risikoen stadig meget lav.
English: Smith et al. 2017 described that stored Gd still decreases after one week so that obviously a transiently stored pool exists which is different from the material that persists long-term.
Danish: Smith et al. 2017 beskrev, at lagret Gd stadig formindskes efter en uge, således at der åbenbart eksisterer en forbigående lagret pool, som adskiller sig fra det materiale, der persisterer på lang sigt.
English: • Gd retention was studied rather early (one week) after cessation of treatment so that detected Gd may not represent the long-term storage form.
Danish: • Gd-retention blev undersøgt ret tidligt (en uge) efter behandlingens ophør, således at det påviste Gd muligvis ikke repræsenterer den langsigtede opbevaringsform.
English: These observations leave the possibility that the method used for the Gd determination is unreliable under certain circumstances.
Danish: Disse observationer kunne indikere, at den metode, der anvendes til Gd-bestemmelsen, er upålidelig under visse omstændigheder.
English: The PRAC considered that a 2nd ad-hoc expert meeting was warranted to address some of the aspects that formed part of the detailed grounds submitted by Bracco and GE Healthcare.
Danish: PRAC anså, at et 2. ad hoc-ekspertmøde var på sin plads til at adressere nogle af de aspekter, der indgik i de detaljerede begrundelser, som var blevet indsendt af Bracco og GE Healthcare.
English: National assessment
Danish: National vurdering
English: Interventional clinical studies comparing the different products could be considered unethical.
Danish: Interventionelle kliniske undersøgelser, der sammenligner de forskellige lægemidler, kunne blive betragtet som uetiske.
English: This is due to the range of potential outcomes of interest, the requirement for long term follow-up, and the heterogeneity of the patient population that undergoes MRI.
Danish: Dette skyldes den vifte af potentielle interesseresultater, kravet om langsigtet opfølgning og heterogeniteten af den patientpopulation, der gennemgår MRI.
English: The macrocyclic agent gadobutrol did not show hyperintensity after this time period.
Danish: Det makrocykliske middel, gadobutrol, viste ikke hyperintensitet efter denne periode.
English: This was discussed with clinical experts within an ad hoc expert group meeting that confirmed a possible association but this has not yet been demonstrated.
Danish: Dette blev drøftet med kliniske eksperter på et ad hoc-ekspertgruppemøde, der bekræftede en mulig forbindelse, men
English: Thus, rather weak binding of linear chelators to Gd becomes obvious in various experiments (including Port et al 2009, Sieber et al 2008), and this makes it unlikely that the complex is fully stable in vivo.
Danish: Således bliver en ret svag binding af lineære chelatdannere til Gd åbenbar i forskellige forsøg (herunder Port et al 2009, Sieber et al. 2008), hvilket gør det usandsynligt, at komplekset er fuldt stabilt in vivo.
English: These areas are involved in the regulation of voluntary and involuntary movement; adverse events could potentially include events such as ataxia, tremors and other movement disorders.
Danish: Disse områder er involveret i reguleringen af frivillig og ufrivillig bevægelse; bivirkninger kan potentielt omfatte hændelser såsom ataksi, tremor og andre bevægelsesforstyrrelser.
English: Indeed there are two phases of liver MRI enhancement with GdCAs:
Danish: Faktisk er der to faser af lever-MRI-forbedring med GdCA'er:
English: Furthermore, the CHMP noted that the changes to the package leaflet for Multihance (gadobenic acid) had not been fully implemented in the PRAC assessment report; the correct wording is provided in the Annex to this opinion.
Danish: Endvidere bemærkede CHMP, at ændringerne i indlægssedlen for MultiHance (gadobensyre) ikke var blevet fuldt ud implementeret i PRAC's vurderingsrapport; den korrekte formulering findes i bilaget til denne udtalelse.
English: These effects can be mimicked in vitro and will further diminish the stability of the GdCA complex in vivo.
Danish: Disse virkninger kan efterlignes in vitro og vil yderligere reducere stabiliteten af GdCA-komplekset in vivo.
English: With regards to the reference to previous assessment conducted at national level (type II variation to extend the indication of Multihance, UK/H/0234/001-002/II/038), it should be noted that the variation application assessment had a different scope than the Article 31 referral procedure and consequently these two procedures are based on a different set of data; therefore a different outcome can be justified.
Danish: Hvad angår henvisningen til tidligere vurdering udført på nationalt plan (type II-variation for udvidet indikation af MultiHance, UK/H/0234/001-002/II/038), skal det bemærkes, at vurderingen af ændringsansøgningen havde et andet omfang end indbringelsesproceduren i artikel 31, hvorfor disse to procedurer er baseret på et andet sæt data; derfor kan et andet resultat begrundes.
English: • The shape and size of the T1 signal is markedly different from the signal shape reported in two other recent publications, (Jost et al., 2016, and Robert et al., 2015) and it is not fully clear whether the region of enhanced signal indeed corresponds to the DN, or other regions in the brain.
Danish: • Formen og størrelsen af T1-signalet er markant forskellig fra den signalform, der blev rapporteret i to andre nyere publikationer (Jost et al., 2016 og Robert et al., 2015), og det er ikke helt klart, om regionen med forbedret signal faktisk svarer til DN eller andre regioner i hjernen.
English: Many of these are common but typically non-serious reactions, such as rash, urticaria, and flushing.
Danish: Mange af disse er almindelige, men typisk ikkealvorlige reaktioner, såsom udslæt, urticaria og rødme.
English: Furthermore, the frequency and timing of applications may not be completely recorded in radiologist's patient file/and or accessible to future contacted radiologist or general practitioner, because the patient has changed the radiologist/general practitioner several times due to change of residence or due to other reasons.
Danish: Desuden er det ikke sikkert, at hyppigheden og timingen af anvendelserne er blevet registreret til fulde i radiologipatientens journal og/eller er tilgængelig for en fremtidigt tilknyttet radiolog eller praktiserende læge, fordi patienten har skiftet radiolog/praktiserende flere gange på grund af skiftende bopæl eller af andre årsager.
English: Furthermore, the standard deviation of Gd content in the brain was extraordinary high for Gadovist.
Danish: Endvidere var standardafvigelsen af Gd-indhold i hjernen ekstraordinær høj for Gadovist.
English: Nevertheless, further analysis did not reveal Gd in them so that a low tissue Gd level was assumed, and it was not questioned what otherwise these dense structures could be.
Danish: Ikke desto mindre afslørede yderligere analyse ikke Gd i dem, så man antog et lavt vævs-Gd-niveau, og der blev ikke stillet spørgsmålstegn ved, hvad disse tætte strukturer ellers kunne være.
English: A number of studies have shown a correlation between the number of exposures to linear GdCAs and the signal intensity changes.
Danish: En række undersøgelser har vist en sammenhæng mellem antallet af eksponeringer for lineære GdCA'er og ændringer i signalintensiteten.
English: Also the restriction of the number of doses administered during the lifetime of a patient raises practical difficulties and therefore would not be effective.
Danish: Også begrænsningen i antallet af indgivne doser i løbet af en patients levetid rejser praktiske vanskeligheder og ville derfor ikke være effektiv.
English: • To complement the information in the SmPC with evidence-based educational programs;
Danish: • Supplering af oplysningerne i produktresuméet med evidensbaserede uddannelsesprogrammer;
English: PRAC considered that it is highly unlikely that the release of Gd from gadodiamide is slower in vivo than in vitro.
Danish: PRAC vurderede, at det er meget usandsynligt, at frigivelsen af Gd fra gadodiamid er langsommere in vivo end in vitro.
English: A restriction by number of doses may not be possible in clinical practice, because previous exposures to GdCAs may not have been recorded sufficiently with regard to the type of GdCA used.
Danish: En begrænsning i antallet af doser kan evt. ikke lade sig gøre i klinisk praksis, fordi tidligere eksponeringer for GdCA'er muligvis ikke er blevet registreret tilstrækkeligt med hensyn til den anvendte type GDCA.
English: The MAHs were also requested to update the safety specifications in the Risk Management Plans for these products to reflect these findings.
Danish: Indehaverne af markedsføringstilladelse blev også anmodet om at opdatere sikkerhedsspecifikationerne i risikostyringsplanerne for disse lægemidler for at afspejle disse resultater.
English: Also, according to this view, it would be important to complement this strategy by efforts to better inform healthcare professionals, particularly practitioners requesting imaging, on the choice of contrast agents depending on the different conditions and indications; to allow for increased overall awareness of risk benefit analysis.
Danish: Og i tråd med denne opfattelse ville det være vigtigt at supplere denne strategi med bestræbelser om at forbedre informeringen af sundhedspersonale, især praktiserende læger, der anmoder om billeddannelse, om valget af kontrastmidler afhængigt af forskellige forhold og indikationer; at muliggøre øget overordnet bevidsthed om risk/benefit-analyse.
English: The absolute rate of hypersensitivity reactions with GdCAs is low and reported as approximately 0.01% to 0.001% across the studies investigating rates of hypersensitivity reactions.
Danish: Den absolutte frekvens af hypersensitivitetsreaktioner med GdCA'er er lav og rapporteret som ca. 0,01% til 0,001% i alle de foretagne undersøgelser af hyppigheden af hypersensitivitetsreaktioner.
English: They are used for contrast enhancement in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA).
Danish: De anvendes til at forbedre kontrasten i magnetisk resonansbilleddannelse (MRI) og magnetisk resonansangiografi (MRA).
English: • the dynamic phase, for which all the authorised GdCAs can provide enhancement of liver imaging,
Danish: • den dynamiske fase, hvori alle de godkendte GdCA'er kan levere forbedret billeddannelse af leveren
English: The levels remained low at 20 weeks and no further reduction was observed at week 50, suggesting that there may be retention of gadolinium in the brain in the long term with no evidence of clearance up to 1 year.
Danish: Niveauerne forblev lave i 20 uger, og der blev ikke observeret nogen yderligere reduktion i uge 50, hvilket indikerer, at der kan være retention af gadolinium i hjernen på lang sigt uden evidens på forsvinden i op til 1 år.
English: Observational clinical studies will have limitations because methods for measuring adverse cognitive or motor neurological outcomes may not be captured by standard methods, or not be measured routinely, and may neither be reliable nor valid.
Danish: Observationsmæssige kliniske undersøgelser vil have begrænsninger, fordi metoder til måling af uønskede kognitive eller motoriske neurologiske resultater måske ikke kan indfanges via standardmetoder eller måske ikke kan måles rutinemæssigt og måske hverken er pålidelige eller gyldige.
English: However, the PRAC considered that the knowledge about brain accumulation and its clinical consequences needed to be further investigated in the appropriate framework, requiring therefore a review at EU level.
Danish: PRAC anså imidlertid, at denne viden om hjerneakkumulering og de kliniske konsekvenser heraf skulle undersøges nærmere inden for passende rammer, hvilket derfor indebar en gennemgang på EU-plan.
English: • To extend the posology to lower doses in specific applications and clinical settings where the advances in technology have shown that to be appropriate.
Danish: • Udvidelse af dosologien til lavere doser i specifikke anvendelser og kliniske omgivelser, hvor de teknologiske fremskridt har vist, at dette vil være passende.
English: • Only a small signal was detected in a brain region which McDonald et al. assumed to be the dentate nucleus (DN), but this assignment is not convincing when regarding the figures shown.
Danish: • Der blev kun påvist et lille signal i en hjerneregion, som McDonald et al. antog at være den tandede kerne (DN), men dette arbejde er ikke overbevisende, når man ser på de viste tal.
English: For all Gd contrast agents, the experts stated that the general “As Low As Reasonably Achievable” (ALARA) principles should be used and that the exposure to all GdCAs should be minimised, either by reducing the dose or using alternative diagnostic methods, if possible.
Danish: For alle Gd-kontrastmidler erklærede eksperterne, at de generelle "så-lavt-som-muligt"-principper (ALARA) bør anvendes, og at eksponeringen for alle GdCA'er bør minimeres, enten ved at reducere dosis eller anvendelse af alternative diagnostiske metoder, hvis dette er muligt.
English: With these uncertainties, conclusions on different or similar behaviour of the different contrast agents studied by McDonald et al. are not possible.
Danish: Med disse usikkerheder in mente kan der ikke drages konklusioner om forskellig eller lignende adfærd hos de forskellige kontrastmidler, der er undersøgt af McDonald et al.
English: Moreover, there is concern that gadolinium deposition could worsen existing inflammatory diseases, as accumulation in inflammatory lesions has been observed.
Danish: Derudover er der bekymring for, at gadoliniumaflejring kan forværre eksisterende inflammatoriske sygdomme, da der er blevet observeret akkumulering i inflammatoriske læsioner.
English: Toxicity of non-chelated gadolinium
Danish: Toksicitet af ikkechelateret gadolinium