natgillin/translations-raw huggingface dataset:
Levofloxacino Serraclinics 
Laboratorios Serra Pamies S.A. Levofloxacino Serraclinics
Ciprofloxacinhydrochlorid 291,1 mg i tabletform 
Ciprofloxacin Hydrochloride 291.1mg Tablet
Levofloxacine Almus Levofloxacinhemihydrat 512,46 mg i tabletform 
Levofloxacine Almus Levofloxacin Hemihydrate 512.46mg Tablet
Levofloxacinhemihydrat 256,23 mg i hætteglas 
Levofloxacin Hemihydrate 256.23mg Vial
Levofloxacină Sandoz Levofloxacinhemihydrat 5,12 mg/ml 
Levofloxacină Sandoz Levofloxacin Hemihydrate 5.12mg/Ml
Ciprofloxacina Almus Ciprofloxacinhydrochloridmon ohydrat 291 mg i tabletform 
Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Ciprofloxacinhydrochlorid 291,5 mg i tabletform 
Ciprofloxacin Hydrochloride 291.5mg Tablet
Ciprofloxacina Almus Ciprofloxacinhydrochloridmon ohydrat 873 mg i tabletform 
Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 500 mg i tabletform 
Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 500mg Tablet
Norfloxacina Sandoz Norfloxacin 400 mg i tabletform 
Norfloxacina Sandoz Norfloxacin 400mg Tablet
Ciprofloxacina Zentiva Ciprofloxacinhydrochloridmon ohydrat 873 mg i tabletform 
Ciprofloxacina Zentiva Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Norfloxacino Sandoz Norfloxacin 400 mg i tabletform 
Norfloxacino Sandoz Norfloxacin 400mg Tablet
Ciprofloxacina Pensa Ciprofloxacinhydrochloridmon ohydrat 500 mg i tabletform 
Ciprofloxacina Pensa Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Levofloxacinhemihydrat 5 mg/ml 
Levofloxacin Hemihydrate 5mg/Ml
Levofloxacine Mylan Levofloxacin 250 mg i tabletform 
Levofloxacine Mylan Levofloxacin 250mg Tablet
Ciprofloxacina Hikma Ciprofloxacinhydrochloridmon ohydrat 873 mg i tabletform 
Ciprofloxacina Hikma Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Ofloxacin Ratiopharm Ofloxacin 200 mg i tabletform Filmovertrukket tablet Til oral anvendelse 
Ofloxacin Ratiopharm Ofloxacin 200mg Tablet
Ofloxacin 200 mg i tabletform Overtrukket tablet 
Ofloxacin 200mg Tablet
Ciprofloxacin Actavis Ciprofloxacinhydrochloridmon ohydrat 250 mg i tabletform 
Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 250mg Tablet
Ciprofloxacine Hikma Ciprofloxacin 200 mg i hætteglas 
Ciprofloxacine Hikma Ciprofloxacin 200mg Vial
Levofloxacina Mylan Levofloxacin 250 mg i tabletform 
Levofloxacina Mylan Levofloxacin 250mg Tablet
Ciprofloxacina Germed Ciprofloxacinhydrochloridmon ohydrat 873 mg i tabletform 
Ciprofloxacina Germed Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Accord Healthcare Limited Levofloxacina Accord Levofloxacinhemihydrat 256,23 mg i tabletform 
Levofloxacina Accord Levofloxacin Hemihydrate 256.23mg Tablet
Ciprofloxacina Sandoz Ciprofloxacin 750 mg i tabletform 
Ciprofloxacina Sandoz Ciprofloxacin 750mg Tablet
Enoxacin 200 mg i tabletform Filmovertrukket tablet Til oral anvendelse 
Pipemidic Acid 400mg Tablet Film-Coated Tablet
Levofloxacina Generis Levofloxacinhemihydrat 256,23 mg i tabletform 
Levofloxacina Generis Levofloxacin Hemihydrate 256.23mg Tablet
Ciprofloxacina Sandoz Ciprofloxacinhydrochloridmon ohydrat 750 mg i tabletform 
Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 750mg Tablet
Ciprofloxacino Cinfa Ciprofloxacinhydrochloridmon ohydrat 250 mg i tabletform 
Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 250mg Tablet
Levofloxacina Hetero Levofloxacinhemihydrat 256,23 mg i tabletform 
Levofloxacin Hetero Levofloxacin Hemihydrate 256.23mg Tablet
Ciprofloxacina Germed Ciprofloxacinhydrochloridmon ohydrat 291 mg i tabletform 
Ciprofloxacina Germed Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Ciprofloxacine Sandoz Ciprofloxacin 750 mg i tabletform 
Ciprofloxacine Sandoz Ciprofloxacin 750mg Tablet
Ciprofloxacinlactat 254 mg/100 ml 
Ciprofloxacin Lactate 254mg/100 Ml
Norfloxacine Ranbaxy Norfloxacin 400 mg i tabletform 
Ranbaxy Pharmacie Generiques Norfloxacine Ranbaxy Norfloxacin 400mg Tablet
Ciprofloxacin Sandoz Ciprofloxacin 750 mg i tabletform 
Ciprofloxacin Sandoz Ciprofloxacin 750mg Tablet
Ciprofloxacina Germed Ciprofloxacinhydrochloridmon ohydrat 582 mg i tabletform 
Ciprofloxacina Germed Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Norfloxacine Sandoz Norfloxacin 400 mg i tabletform 
Norfloxacine Sandoz Norfloxacin 400mg Tablet
Ciprofloxacino Cinfa Ciprofloxacinhydrochloridmon ohydrat 500 mg i tabletform 
Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Levofloxacinhemihydrat 512,46 mg i tabletform 
Levofloxacin 512,46mg Tablet Film-Coated Tablet
Grækenland Farmellas Enterprises Ltd Cipromycin 
Farmellas Enterprises Ltd
Ciprofloxacina Almus Ciprofloxacinhydrochloridmon ohydrat 582 mg i tabletform 
Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Ciprofloxacina Mylan Ciprofloxacin 250 mg i tabletform 
Ciprofloxacina Mylan Ciprofloxacin 250mg Tablet
Levofloxacina Germed Levofloxacinhemihydrat 512,46 mg i tabletform 
Levofloxacina Germed Levofloxacin Hemihydrate 512.46mg Tablet
Moxifloxacinhydrochlorid 436,37 mg i beholder 
Moxifloxacin Hydrochloride 436.37mg Container
Levofloxacine Sandoz Levofloxacin 250 mg i tabletform 
Levofloxacine Sandoz Levofloxacin 250mg Tablet
Axcount Generika Gmbh Ciprofloxacin Axcount Ciprofloxacin 500 mg i tabletform 
Ciprofloxacin Axcount Ciprofloxacin 500mg Tablet
Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Ciprofloxacinhydrochlorid 500 mg i tabletform 
Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 500mg Tablet
Levofloxacino Mylan Levofloxacin 500 mg i tabletform 
Levofloxacino Mylan Levofloxacin 500mg Tablet
Levofloxacina Sandoz Levofloxacin 250 mg i tabletform 
Levofloxacina Sandoz Levofloxacin 250mg Tablet
Ciprofloxacinhydrochlorid 582 mg i tabletform 
Ciprofloxacin Hydrochloride 582mg Tablet
Levofloxacinhemihydrat 500 mg/100 ml 
Levofloxacin Hemihydrate 500mg/100 Ml
Aurobindo Pharma Gmbh Moxifloxacin Aurobindo Moxifloxacinhydrochlorid 436,32 mg i tabletform 
Moxifloxacin Aurobindo Moxifloxacin Hydrochloride 436.32mg Tablet
Levofloxacin Mylan Levofloxacin 250 mg i tabletform 
Levofloxacin Mylan Levofloxacin 250mg Tablet
Ciprofloxacine Mylan Ciprofloxacin 250 mg i tabletform 
Ciprofloxacine Mylan Ciprofloxacin 250mg Tablet
Moxifloxacino Mylan Moxifloxacin 400 mg i tabletform 
Moxifloxacino Mylan Moxifloxacin 400mg Tablet
Ciprofloxacin Actavis Ciprofloxacinhydrochloridmon ohydrat 500 mg i tabletform 
Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Nederlandene Fairmed Healthcare Gmbh Ciprofloxacine FairMed 
Netherlands Fairmed Healthcare Gmbh
Ciprofloxacin Mylan Ciprofloxacin 250 mg i tabletform 
Ciprofloxacin Mylan Ciprofloxacin 250mg Tablet
Ciprofloxacinhydrochlorid 291 mg i tabletform 
Ciprofloxacin Hydrochloride 291mg Tablet
Moxifloxacin Sandoz Moxifloxacinhydrochlorid 400 mg i tabletform 
Moxifloxacin Sandoz Moxifloxacin Hydrochloride Film-Coated Tablet
Ciprofloxacin Mylan Ciprofloxacin 500 mg i tabletform 
Ciprofloxacin Mylan Ciprofloxacin 500mg Tablet
Macleods Pharma Uk Ltd Levofloxacin Macleods Levofloxacinhemihydrat 512,46 mg i tabletform 
Levofloxacin Macleods Levofloxacin Hemihydrate 512.46mg Tablet
Ciprofloxacinlactat 254,4 mg i hætteglas 
Ciprofloxacin Lactate 254.4mg Vial
Moxifloxacino Sandoz Moxifloxacin 400 mg i tabletform 
Moxifloxacino Sandoz Moxifloxacin 400mg Tablet
Ciprofloxacina Mylan Ciprofloxacin 500 mg i tabletform 
Ciprofloxacina Mylan Ciprofloxacin 500mg Tablet
Levofloxacino Sandoz Levofloxacin 500 mg i tabletform 
Levofloxacino Sandoz Levofloxacin 500mg Tablet
Ciprofloxacina Sandoz Ciprofloxacin 500 mg i tabletform 
Ciprofloxacina Sandoz Ciprofloxacin 500mg Tablet
Ciprofloxacino Sandoz Ciprofloxacin 500 mg i tabletform 
Ciprofloxacino Sandoz Ciprofloxacin 500mg Tablet
Moxifloxacina Sandoz Moxifloxacin 400 mg i tabletform 
Moxifloxacina Sandoz Moxifloxacin 400mg Tablet
Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Ciprofloxacinhydrochlorid 250 mg i tabletform 
Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 250mg Tablet
Levofloxacine Mylan Levofloxacin 500 mg i tabletform 
Levofloxacine Mylan Levofloxacin 500mg Tablet
Levofloxacine Pch Levofloxacinhemihydrat 256,23 mg i tabletform 
Levofloxacine Jubilant Levofloxacin Hemihydrate 256.23mg Tablet
Levofloxacina Mylan Levofloxacin 500 mg i tabletform 
Levofloxacina Mylan Levofloxacin 500mg Tablet
Levofloxacina Sandoz Levofloxacin 500 mg i tabletform 
Levofloxacina Sandoz Levofloxacin 500mg Tablet
Moxifloxacina Mylan Moxifloxacin 400 mg i tabletform 
Moxifloxacina Mylan Moxifloxacin 400mg Tablet
Arcana Arzneimittel Gmbh Levofloxacin Arcana Levofloxacin 250 mg/50 ml 
Levofloxacin Arcana Levofloxacin 250mg/50 Ml
Ciprofloxacina Sandoz Ciprofloxacin 250 mg i tabletform 
Ciprofloxacina Sandoz Ciprofloxacin 250mg Tablet
Ciprofloxacine Mylan Ciprofloxacin 500 mg i tabletform 
Ciprofloxacine Mylan Ciprofloxacin 500mg Tablet
Ciprofloxacina Sandoz Ciprofloxacinhydrochloridmon ohydrat 500 mg i tabletform 
Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Levofloxacine Pch Levofloxacinhemihydrat 512,46 mg i tabletform 
Levofloxacine Jubilant Levofloxacin Hemihydrate 512.46mg Tablet
Macleods Pharma Uk Ltd Levofloxacin Macleods Levofloxacinhemihydrat 256,23 mg i tabletform 
Levofloxacin Macleods Levofloxacin Hemihydrate 256.23mg Tablet
Levofloxacine Sandoz Levofloxacin 500 mg i tabletform 
Levofloxacine Sandoz Levofloxacin 500mg Tablet
Moxifloxacin Mylan Moxifloxacin 400 mg i tabletform 
Moxifloxacin Mylan Moxifloxacin 400mg Tablet
Levofloxacin Mylan Levofloxacin 500 mg i tabletform 
Levofloxacin Mylan Levofloxacin 500mg Tablet
Moxifloxacine Sandoz Moxifloxacin 400 mg i tabletform 
Moxifloxacine Sandoz Moxifloxacin 400mg Tablet
Ciprofloxacín Sandoz Ciprofloxacin 500 mg i tabletform 
Ciprofloxacín Sandoz Ciprofloxacin 500mg Tablet
Levofloxacino Combix Levofloxacinhemihydrat 512,46 mg i tabletform 
Levofloxacina Generis Levofloxacin Hemihydrate 512.46mg Tablet
Ciprofloxacine Sandoz Ciprofloxacin 500 mg i tabletform 
Ciprofloxacine Sandoz Ciprofloxacin 500mg Tablet
Moxifloxacine Mylan Moxifloxacin 400 mg i tabletform 
Moxifloxacine Mylan Moxifloxacin 400mg Tablet
Axcount Generika Gmbh Ciprofloxacin Axcount Ciprofloxacin 250 mg i tabletform 
Ranbaxy Pharmacie Generiques Ciprofloxacine Ranbaxy Ciprofloxacin 250mg Tablet
Levofloxacin Sandoz Levofloxacin 500 mg i tabletform 
Levofloxacin Sandoz Levofloxacin 500mg Tablet
Ciprofloxacín Sandoz Ciprofloxacin 250 mg i tabletform 
Ciprofloxacín Sandoz Ciprofloxacin 250mg Tablet
Ofloxacine Ranbaxy Ofloxacin 200 mg i tabletform Filmovertrukket tablet Til oral anvendelse 
Ranbaxy Pharmacie Generiques Ofloxacine Ranbaxy Ofloxacin 200mg Tablet
Ciprofloxacine Sandoz Ciprofloxacin 250 mg i tabletform 
Ciprofloxacine Sandoz Ciprofloxacin 250mg Tablet
Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacinhydrochlorid 873 mg i tabletform 
Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 873mg Tablet
Ciprofloxacin Sandoz Ciprofloxacin 500 mg i tabletform 
Ciprofloxacin Sandoz Ciprofloxacin 500mg Tablet
Moxifloxacin Sandoz Moxifloxacin 400 mg i tabletform 
Moxifloxacin Sandoz Moxifloxacin 400mg Tablet
Levofloxacin Sandoz Levofloxacin 250 mg i tabletform 
Levofloxacin Sandoz Levofloxacin 250mg Tablet
Levofloxacine Ranbaxy Levofloxacin 500 mg i tabletform 
Ranbaxy Pharmacie Generiques Levofloxacine Ranbaxy Levofloxacin 500mg Tablet
Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacinhydrochlorid 582 mg i tabletform 
Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 582mg Tablet
Alle dyr skal have fået vand fra samme kilde. 
All animals should have had water from the same source
Dødsfald er ekstremt sjældne. 
Fatalities are extremely rare.
Derfor opretholdes denne erklæring ikke. 
Therefore this statement is not maintained.
Forfatterne kunne ikke give en god forklaring på dette. 
The authors could not provide a sound explanation for this.
Andre sikkerhedsaspekter 
Other safety aspects
Disse effekter kan være forsinket og subtile. 
These effects might be delayed and subtle.
Og indførelsen af undervisningsmateriale vil heller ikke løse dette problem. 
Neither would the introduction of educational material address this issue.
Men hvis sådanne undersøgelser skulle udføres, ville patienterne bære risikoen, så længe den igangværende forskning ikke er afsluttet. 
In case such studies were however to be carried out, patients would bear the risks as long as ongoing research is not completed.
Især blev det anført, at indflydelsen på patientadministrationen ikke var direkte påvist af undersøgelsens resultater. 
Particularly, it was stated that the influence on patient management was not directly demonstrated by the study results.
Derudover er gentagen brug af disse lægemidler meget usandsynlig. 
In addition, the repeated use of these products is most unlikely.
Dette indikerer klart, at potentiel dechelatering i kroppen er et anerkendt fænomen. 
This clearly indicates that potential dechelation in the body is a recognised phenomenon.
Hvor 
Whereas
Det er ikke sandsynligt, at sådanne langsigtede sikkerhedsundersøgelser er mulige inden for rimelig tid. 
Such long-term safety studies are unlikely to be feasible within reasonable period of time.
Detaljerede konklusioner fra mødet kan findes i bilag 11 til PRAC's vurderingsrapport. 
Detailed conclusions from the meeting can be found in the enclosure 11 to the PRAC assessment report.
Højere relaksivitet af MultiHance 
Higher relaxivity of Multihance
Præmedicinering med antihistaminer og kortikosteroider kan også anvendes. 
Premedication with antihistamines and corticosteroids could also be applied.
Eksperterne på ad hocekspertmødet delte de samme synspunkter. 
The experts at the ad-hoc expert meeting shared these same views.
De lineære forbindelser persisterer derfor især i hjernen. 
The linear compounds therefore particularly persist in the brain.
Organspecifik indikation for Omniscan 
Organ-specific indication for Omniscan
• Den praktiske gennemførelse af disse foranstaltninger anses i øvrigt ikke for mulig i et klinisk miljø. 
• The practical implementation of these measures is moreover not deemed feasible in a clinical setting.
Nefrogen systemisk fibrose (NSF) 
Nephrogenic systemic fibrosis (NSF)
I overensstemmelse med artikel 107k i direktiv 2001/83/EF behandlede CHMP PRAC's anbefaling vedtaget den 6. juli 2017. 
In accordance with Article 107k of Directive 2001/83/EC, the CHMP considered the PRAC recommendation adopted on 6 July 2017.
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. 
All GdCAs have some degree of renal elimination, which varies from 50% for gadoxetic acid to 100% for most other members of the class.
Langt de fleste af disse reaktioner er ikke alvorlige, med en meget lav procentdel af patienter der oplever alvorlige hypersensitivitetsreaktioner. 
The vast majority of these reactions are non-serious, with a very low percentage of patients experiencing severe hypersensitivity reactions.
Desuden er det ikke muligt at definere en periode, hvor ingen potentiel bivirkning ikke vil have tid til at manifestere sig. 
Additionally, it is not possible to define a period of time during which no potential adverse effect would have time to manifest.
Det er ikke helt klart, hvor pålidelig metoden til Gd-kvantificering i væv var. 
It is not fully clear how reliable the method of Gd quantification in tissue was.
Trods global brug er alvorlige bivirkninger sjældne; urticaria er den mest almindelige manifestation. 
Despite worldwide use serious adverse reactions are rare; urticaria is the most common manifestation.
Hudpriktest kunne lette identifikationen af en alternativ GDCA. 
Skin prick testing could facilitate the identification of an alternative GdCA.
Generelt kan passende medicin, udstyr og personale med erfaring i behandling af hypersensitivitetsreaktioner forventes i enhver radiologisk praksis. 
In general, appropriate medications, equipment and staff experienced in the management of hypersensitivity reactions can be expected in any radiological practice.
Population-specifik indikation for MultiHance 
Population-specific indication for Multihance
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. 
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.
De implementerede risikominimeringsforanstaltninger synes at være effektive ud fra årlige gennemgange af spontane sagsrapporter. 
The implemented risk minimisation measures appear to be effective based on annual reviews of spontaneous case reports.
Men det viser kompleksiteten og de vanskeligheder, der er forbundet med at analysere potentielle neurologiske virkninger. 
However, it demonstrates the complexity and difficulties associated with the objective of analysing potential neurological effects.
Denne dissociation antages at være relateret til forskelle i kompleksernes stabilitet blandt de forskellige typer GdCA'er (Spencer et al. 1997). 
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).
På baggrund af ovenstående konkluderede PRAC, at: 
In view of the above, the PRAC concluded that:
Gadolinium-associerede plaques 
Gadolinium-associated plaques
Det bør noteres, at McDonald et al. (2017) rapporterede om meget lille Gd-aflejring. 
It should be noted that McDonald et al. (2017) reported very little Gd deposition.
Data fra de kliniske post mortem-undersøgelser er heterogene, og det er derfor vanskeligt at sammenligne niveauerne. 
Data from the clinical post-mortem studies are heterogeneous and it is therefore difficult to compare the levels.
Selv om der kan være øget reaktionsrisiko hos patienter med tidligere medicinallergi, er risikoen stadig meget lav. 
Although in patients with a history of drug allergy the reaction risk might be increased, the risk is still very low.
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. 
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.
• Gd-retention blev undersøgt ret tidligt (en uge) efter behandlingens ophør, således at det påviste Gd muligvis ikke repræsenterer den langsigtede opbevaringsform. 
• Gd retention was studied rather early (one week) after cessation of treatment so that detected Gd may not represent the long-term storage form.
Disse observationer kunne indikere, at den metode, der anvendes til Gd-bestemmelsen, er upålidelig under visse omstændigheder. 
These observations leave the possibility that the method used for the Gd determination is unreliable under certain circumstances.
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. 
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.
National vurdering 
National assessment
Interventionelle kliniske undersøgelser, der sammenligner de forskellige lægemidler, kunne blive betragtet som uetiske. 
Interventional clinical studies comparing the different products could be considered unethical.
Dette skyldes den vifte af potentielle interesseresultater, kravet om langsigtet opfølgning og heterogeniteten af den patientpopulation, der gennemgår MRI. 
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.
Det makrocykliske middel, gadobutrol, viste ikke hyperintensitet efter denne periode. 
The macrocyclic agent gadobutrol did not show hyperintensity after this time period.
Dette blev drøftet med kliniske eksperter på et ad hoc-ekspertgruppemøde, der bekræftede en mulig forbindelse, men 
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.
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. 
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.
Disse områder er involveret i reguleringen af frivillig og ufrivillig bevægelse; bivirkninger kan potentielt omfatte hændelser såsom ataksi, tremor og andre bevægelsesforstyrrelser. 
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.
Faktisk er der to faser af lever-MRI-forbedring med GdCA'er: 
Indeed there are two phases of liver MRI enhancement with GdCAs:
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. 
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.
Disse virkninger kan efterlignes in vitro og vil yderligere reducere stabiliteten af GdCA-komplekset in vivo. 
These effects can be mimicked in vitro and will further diminish the stability of the GdCA complex in vivo.
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. 
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.
• 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. 
• 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.
Mange af disse er almindelige, men typisk ikkealvorlige reaktioner, såsom udslæt, urticaria og rødme. 
Many of these are common but typically non-serious reactions, such as rash, urticaria, and flushing.
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. 
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.