natgillin/translations-raw huggingface dataset:
Ciprofloxacine Zydus Ciprofloxacin 250mg Tablet 
Ciprofloxacine Zydus ciprofloksacin 250 mg tableta filmsko obložena tableta
Levofloxacine B. Braun Levofloxacin 5mg/Ml 
Levofloxacine B. Braun levofloksacin 5 mg/ml
Ciprofloxacin Hydrochloride 582.2mg Tablet 
ciprofloksacinijev klorid 582,16 mg tableta
Moxifloxacin Hydrochloride 436.8mg Tablet 
Moxifloxacina Cinfa moksifloksacinijev klorid 436,8 mg tableta
Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 582mg Tablet 
Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med ciprofloksacinijev klorid 582 mg tableta
Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 291mg Tablet 
Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med ciprofloksacinijev klorid 291 mg tableta
Ciprofloxacino Tevagen Ciprofloxacin 250mg Tablet 
Ciprofloxacino Tevagen ciprofloksacin 250 mg tableta filmsko obložena tableta
Levofloxacino Sandoz Levofloxacin 500mg Tablet 
Levofloxacino Sandoz levofloksacin 500 mg tableta filmsko obložena tableta
Levofloxacin Arcana Levofloxacin 250mg/50 Ml 
Arcana Arzneimittel Gmbh Levofloxacin Arcana levofloksacin 250 mg/50 ml
Levofloxacin Aurobindo Levofloxacin 500mg Tablet 
Levofloxacin Aurobindo levofloksacin 500 mg tableta filmsko obložena tableta
Ofloxacin 100mg Tablet 
Oflox ofloksacin 100 mg tableta filmsko obložena tableta
Ranbaxy Pharmacie Generiques Norfloxacine Ranbaxy Norfloxacin 400mg Tablet 
Norfloxacine Ranbaxy norfloksacin 400 mg tableta filmsko obložena tableta
Ciprofloxacine Mylan Ciprofloxacin 200mg/100 Ml 
Ciprofloxacine Mylan ciprofloksacin 200 mg/100 ml raztopina za infundiranje
Levofloxacina Accord Levofloxacin Hemihydrate 256.23mg Tablet 
Accord Healthcare Limited Levofloxacina Accord levofloksacin hemihidrat 256,23 mg tableta
Levofloxacina Actavis Levofloxacin 500mg Tablet 
Levofloxacin Actavis Group levofloksacin hemihidrat 500 mg tableta
Ciprofloxacina Hikma Ciprofloxacin 200mg/100 Ml 
Ciprofloxacina Hikma ciprofloksacin 200 mg/100 ml raztopina za infundiranje
Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 250mg Tablet 
Portugalska Bluefish Pharmaceuticals Ab Levofloxacina Bluefish levofloksacin 250 mg tableta filmsko obložena tableta
Ciprofloxacin Hydrochloride 291.1mg Tablet 
Ciprofloxacin ciprofloksacinijev klorid 291,5 mg tableta
Intravenous Use 
Pot uporabe
Levofloksacin B. Braun Levofloxacin 500mg/100 Ml 
Levofloksacin B. Braun levofloksacin 500 mg/100 ml
Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet 
Ciprofloxacino Cinfa ciprofloksacinijev klorid monohidrat 500 mg tableta obložena tableta
Moxifloxacino Sandoz Moxifloxacin 400mg Tablet 
Moxifloxacino Sandoz moksifloksacin 400 mg tableta
Levofloxacina Tecnigen Levofloxacin 500mg Tablet 
Levofloxacina Tecnigen levofloksacin 500 mg tableta filmsko obložena tableta
Levofloxacin B. Braun Levofloxacin 500mg/100 Ml 
Levofloxacin B. Braun levofloksacin 500 mg/100 ml
Levofloxacina Ciclum Levofloxacin 250mg Tablet 
Levofloxacina Ciclum levofloksacin 250 mg tableta filmsko obložena tableta
Ciprofloxacin Fair-Med Ciprofloxacin Hydrochloride 582mg Tablet 
Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Healthcare ciprofloksacinijev klorid 582mg tableta
Mediolanum Farmaceutici Spa Qari 
Mediolanum Farmaceutici Spa Qari rufloksacinijev klorid 200 mg tableta
Ciprofloxacin Lactate 2.544mg/Ml 
Dilon ciprofloksacinijev laktat 2,544 mg/ml
Moxifloxacina Sandoz Moxifloxacin 400mg Tablet 
Moxifloxacina Sandoz moksifloksacin 400 mg tableta
Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 500mg Tablet 
Portugalska Bluefish Pharmaceuticals Ab Levofloxacina Bluefish levofloksacin 500 mg tableta filmsko obložena tableta
Levofloxacino B. Braun Levofloxacin 500mg/100 Ml 
Levofloxacino B. Braun levofloksacin 500 mg/100 ml
Levofloxacine Almus Levofloxacin Hemihydrate 512.46mg Tablet 
Levofloxacine Almus levofloksacin hemihidrat 512,46 mg tableta obložena tableta
Ciprofloxacina Actavis Ciprofloxacin 500mg Tablet 
Ciprofloxacina Actavis ciprofloksacin 500 mg tableta filmsko obložena tableta
Ciprofloxacina Mylan Ciprofloxacin 750mg Tablet 
Ciprofloxacina Mylan ciprofloksacin 750 mg tableta filmsko obložena tableta
Ciprofloxacina Sandoz Ciprofloxacin 750mg Tablet 
Ciprofloxacina Sandoz ciprofloksacin 750 mg tableta filmsko obložena tableta
Ciprofloxacin Actavis Ciprofloxacin 500mg Tablet 
Ciprofloxacin Actavis ciprofloksacin 500 mg tableta filmsko obložena tableta
Levofloxacine Jubilant Levofloxacin Hemihydrate 512.46mg Tablet 
Levofloxacin levofloksacin hemihidrat 512,46 mg tableta
Levofloxacin Mylan Levofloxacin 500mg Tablet 
Levofloxacino Mylan levofloksacin 500 mg tableta filmsko obložena tableta
Ciprofloxacin Hikma Ciprofloxacin 200mg/100 Ml 
Ciprofloxacin Hikma ciprofloksacin 200 mg/100 ml raztopina za infundiranje
Ciprofloxacin Hydrochloride 582mg Tablet 
Ciprinol ciprofloksacinijev klorid 582 mg tableta
Levofloxacina B. Braun Levofloxacin 500mg/100 Ml 
Levofloxacina B. Braun levofloksacin 500 mg/100 ml
Moxifloxaxino Normon Moxifloxacin 400mg Units 
Moxifloxaxino Normon moksifloksacin 400 mg enote filmsko obložena tableta
Ciprofloxacine Sandoz Ciprofloxacin 750mg Tablet 
Ciprofloxacine Sandoz ciprofloksacin 750 mg tableta filmsko obložena tableta
Moxifloxacina Mylan Moxifloxacin 400mg Tablet 
Moxifloxacina Mylan moksifloksacin 400 mg tableta
Moxifloxacin Sandoz Moxifloxacin 400mg Tablet 
Moxifloxacin Sandoz moksifloksacin 400 mg tableta
Moxifloxacin Hydrochloride 400mg Tablet 
Moxifloxacin Hexal moksifloksacin 400 mg tableta
Ciprofloxacin Hydrochloride 500mg Tablet 
Ciprofloxacine Alter ciprofloksacinijev klorid 500 mg tableta
Ciprofloksacin Sandoz Ciprofloxacin Hydrochloride 500mg Tablet 
Ciprofloksacin Sandoz ciprofloksacinijev klorid 500 mg tableta
Ciprofloxacin Hydrochloride 250mg Tablet 
Cifloxin ciprofloksacinijev klorid 250 mg tableta
Ciprofloxacin Sandoz Ciprofloxacin 750mg Tablet 
Ciprofloxacin Sandoz ciprofloksacin 750 mg tableta filmsko obložena tableta
Moxifloxacine Sandoz Moxifloxacin 400mg Tablet 
Moxifloxacine Sandoz moksifloksacin 400 mg tableta
Moxifloxacin Actavis Moxifloxacin Hydrochloride 400mg Tablet 
Moxifloxacin Actavis moksifloksacinijev klorid 400 mg tableta
Levofloxacine Sandoz Levofloxacin 500mg Tablet 
Levofloxacine Sandoz levofloksacin 500 mg tableta filmsko obložena tableta
Levofloxacine Mylan Levofloxacin 250mg Tablet 
Levofloxacina Mylan levofloksacin 250 mg tableta filmsko obložena tableta
Ciprofloxacin Hydrochloride 750mg Tablet 
Ciprofloxacin Teva ciprofloksacinijev klorid 750 mg tableta
Levofloxacine Sandoz Levofloxacin 250mg Tablet 
Levofloxacina Sandoz levofloksacin 250 mg tableta filmsko obložena tableta
Levofloxacine Jubilant Levofloxacin Hemihydrate 256.23mg Tablet 
Levofloxacin levofloksacin hemihidrat 256,23 mg tableta
Ciprofloxacin Lactate 2.55mg/Ml 
Ufexil ciprofloksacinijev laktat 2,55 mg/ml
Levofloxacin Mylan Levofloxacin 250mg Tablet 
Levofloxacin Mylan levofloksacin 250 mg tableta filmsko obložena tableta
Cooper S.A. Pharmaceuticals Levofloxacin Cooper 
Cooper S.A. Pharmaceuticals Levofloxacin Cooper levofloksacin 5 mg/ml
Levofloxacina Sandoz Levofloxacin 500mg Tablet 
Levofloxacina Sandoz levofloksacin 500 mg tableta filmsko obložena tableta
Ciprofloxacin Hydrochloride 528mg Tablet 
Megaflox ciprofloksacinijev klorid 528 mg tableta obložena tableta
Ciprofloxacina Actavis Ciprofloxacin 750mg Tablet 
Ciprofloxacina Actavis ciprofloksacin 750 mg tableta filmsko obložena tableta
Ciprofloxacín Sandoz Ciprofloxacin 500mg Tablet 
Ciprofloxacín Sandoz ciprofloksacin 500 mg tableta filmsko obložena tableta
Ciprofloxacina Mylan Ciprofloxacin 500mg Tablet 
Ciprofloxacina Mylan ciprofloksacin 500 mg tableta filmsko obložena tableta
Levofloxacin Sandoz Levofloxacin 250mg Tablet 
Levoxa levofloksacin hemihidrat 250 mg tableta
Levofloxacin Accord Levofloxacin 500mg/100 Ml 
Accord Healthcare Limited Levofloxacin Accord levofloksacin 500 mg/100 ml
All animals should have had water from the same source 
Vse živali bi morale imeti vodo iz istega vira;
Therefore this statement is not maintained. 
Ta navedba zato ni bila ohranjena.
Fatalities are extremely rare. 
Smrtni primeri so izjemno redki.
Other safety aspects 
Drugi varnostni vidiki
Neither would the introduction of educational material address this issue. 
Tudi uvedba izobraževalnega gradiva ne bi rešila tega vprašanja.
The authors could not provide a sound explanation for this. 
Avtorji tega niso mogli ustrezno pojasniti.
In addition, the repeated use of these products is most unlikely. 
Poleg tega je večkratna uporaba teh izdelkov zelo malo verjetna.
Detailed conclusions from the meeting can be found in the enclosure 11 to the PRAC assessment report. 
Podrobni zaključki s sestanka so na voljo v prilogi 11 k poročilu odbora PRAC o oceni.
Therefore the condition should not mention “including the brains in human.” 
V pogoju se zato ne bi smelo navesti „vključno z možgani pri ljudeh“;
In view of the above, the PRAC concluded that: 
Odbor PRAC je glede na navedeno zaključil, da:
Interventional clinical studies comparing the different products could be considered unethical. 
Intervencijske klinične študije za primerjavo različnih izdelkov pa bi se lahko štele za neetične.
These effects might be delayed and subtle. 
Ti učinki so lahko zapozneli in komaj zaznavni.
The vast majority of these reactions are non-serious, with a very low percentage of patients experiencing severe hypersensitivity reactions. 
Velika večina teh reakcij ni huda, zelo majhen odstotek bolnikov pa ima hude preobčutljivostne reakcije.
Such long-term safety studies are unlikely to be feasible within reasonable period of time. 
Take študije dolgoročne varnosti verjetno v razumnem času ne bi bile izvedljive.
In case such studies were however to be carried out, patients would bear the risks as long as ongoing research is not completed. 
Če bi se take študije vseeno izvedle, bi bili bolniki izpostavljeni tveganju do zaključka zadevnih raziskav.
The long-term clinical consequences of such gadolinium retention are currently unknown. 
Dolgoročne klinične posledice takega zadrževanja gadolinija trenutno niso znane.
Additionally, it is not possible to define a period of time during which no potential adverse effect would have time to manifest. 
Prav tako ni mogoče opredeliti časovnega obdobja, v katerem bi se morebitni neželeni učinek lahko pokazal.
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. 
O tem se je razpravljalo s kliničnimi strokovnjaki na ad hoc sestanku strokovne skupine, na katerem je bila mogoča povezava potrjena, vendar še ni bila dokazana.
The linear compounds therefore particularly persist in the brain. 
Linearne spojine se torej ohranijo predvsem v možganih.
National assessment 
Nacionalna ocena
Premedication with antihistamines and corticosteroids could also be applied. 
Lahko se uporabi tudi premedikacija z antihistaminiki in kotrikosteroidi.
However, it demonstrates the complexity and difficulties associated with the objective of analysing potential neurological effects. 
Pokazala pa je kompleksnost in težave, povezane s ciljem analizirati morebitne nevrološke učinke;
This clearly indicates that potential dechelation in the body is a recognised phenomenon. 
To jasno kaže, da je potencialna dekelacija v telesu priznan pojav.
Data from the clinical post-mortem studies are heterogeneous and it is therefore difficult to compare the levels. 
Podatki iz kliničnih študij post mortem so heterogeni, zato je ravni težko primerjati.
Higher relaxivity of Multihance 
Višja relaksivnost sredstva Multihance
• The practical implementation of these measures is moreover not deemed feasible in a clinical setting. 
• Poleg tega praktično izvajanje teh ukrepov v kliničnem okolju ne bi bilo izvedljivo.
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. 
Odbor PRAC je zato menil, da McDonaldova študija ne spreminja njegovih prvotnih zaključkov, in poudaril, da je to stališče 19. junija podprla tudi ad hoc strokovna skupina.
Overall, the experts expressed divergent views concerning the risk minimisation measures. 
Strokovnjaki so v zvezi z ukrepi za zmanjšanje tveganja na splošno izrazili različna stališča.
Although in patients with a history of drug allergy the reaction risk might be increased, the risk is still very low. 
Čeprav je morda pri bolnikih z anamnezo alergije na zdravilo tveganje za reakcijo večje, je to tveganje še vedno majhno.
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). 
Ta disociacija naj bi bila povezana z razlikami v stabilnosti kompleksov med različnimi vrstami sredstev GdCA (Spencer idr., 1997).
Particularly, it was stated that the influence on patient management was not directly demonstrated by the study results. 
Posebej je bilo poudarjeno, da rezultati študije niso neposredno pokazali vpliva na obravnavanje bolnika.
The MAHs were also requested to update the safety specifications in the Risk Management Plans for these products to reflect these findings. 
Tudi imetniki dovoljenja za promet z zdravilom so bili pozvani, naj v načrtih za obvladovanje tveganja za te izdelke posodobijo varnostne specifikacije za upoštevanje teh ugotovitev.
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. 
Odbor PRAC je menil, da je treba podatke o kopičenju v možganih in njegovih kliničnih posledicah dodatno proučiti v ustreznem okviru, za kar bo potreben pregled na ravni EU.
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. 
V zvezi s sklicevanjem na predhodno oceno, izvedeno na nacionalni ravni (sprememba tipa II za razširitev indikacije sredstva Multihance, UK/H/0234/001-002/II/038), je treba poudariti, da je bil obseg ocene zahtevka za spremembo drugačen kot pri postopku napotitve iz člena 31, zato ta dva postopka temeljita na različnem sklopu podatkov in je različen rezultat mogoče utemeljiti.
Overall summary of the scientific evaluation by the PRAC Background 
Splošni povzetek znanstvenega vrednotenja odbora PRAC Ozadje
Feasibility of clinical studies 
Izvedljivost kliničnih študij
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. 
Poleg tega je opozoril, da spremembe navodila za uporabo sredstva Multihance (gadobenska kislina) v poročilu odbora PRAC o oceni niso bile v celoti izvedene; pravilno besedilo je navedeno v prilogi k temu mnenju.
Another group of experts supported the view that macrocyclic agents are more stable and are preferable as first line contrast agents. 
Druga skupina strokovnjakov je podprla stališče, da so makrociklična sredstva stabilnejša in zaželena kot prva izbira kontrastnih sredstev.
The experts at the ad-hoc expert meeting shared these same views. 
Enako stališče so zavzeli strokovnjaki na ad hoc strokovnem sestanku.
• 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. 
• oblika in velikost signala T1 se izrazito razlikujeta od oblike signala, navedene v dveh drugih nedavnih publikacijah (Jost idr., 2016, ter Robert idr., 2015), in ni popolnoma jasno, ali predel s povečanim signalom dejansko ustreza DN ali pa drugim predelom v možganih;
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. 
Vzrok za to so različni mogoči izidi interesov, zahteva za dolgoročno nadaljnje spremljanje in heterogenost populacije bolnikov, ki opravijo MRI;
Following the adoption of the PRAC recommendation during the March 2017 PRAC meeting, two MAHs (Bracco and GE Healthcare) expressed their disagreement with the initial PRAC recommendation. 
Po sprejetju priporočila odbora PRAC marca 2017 na sestanku odbora PRAC sta dva imetnika dovoljenja za promet z zdravilom (Bracco in GE Healthcare) izrazila nestrinjanje s prvotnim priporočilom odbora PRAC.
For gadobenic acid, the available studies do not establish differences in relaxivity, image quality and technical performance. 
Za gadobensko kislino razpoložljive študije ne ugotavljajo razlik v relaksivnosti, kakovosti slike in tehnični zmogljivosti.
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. 
Odbor PRAC je menil, da je drugi ad hoc strokovni sestanek omogočil obravnavanje nekaterih vidikov iz podrobno opisanih razlogov, ki sta jih predložila Bracco in GE Healthcare.
It is not fully clear how reliable the method of Gd quantification in tissue was. 
Ni popolnoma jasno, kako zanesljiva je bila metoda količinske opredelitve gadolinija v tkivu;
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. 
V skladu s tem stališčem bi bilo tudi pomembno to strategijo dopolniti s prizadevanjem za boljše obveščanje zdravstvenih delavcev, zlasti zdravnikov, ki naročijo slikanje, o izbiri kontrastnih sredstev glede na različne bolezni in indikacije, za večjo splošno ozaveščenost o analizi razmerja med tveganji in koristmi.
Toxicity of non-chelated gadolinium 
Toksičnost nekelatiranega gadolinija
They are used for contrast enhancement in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). 
Uporabljajo se za izboljšanje kontrasta pri magnetnoresonančnem slikanju (MRI) in magnetnoresonančni angiografiji (MRA).
In accordance with Article 107k of Directive 2001/83/EC, the CHMP considered the PRAC recommendation adopted on 6 July 2017. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je v skladu s členom 107k Direktive 2001/83/ES proučil priporočilo Odbora za oceno tveganja na področju farmakovigilance (PRAC), sprejeto 6. julija 2017.
In addition, macrocyclic agents are associated with a low risk of NSF. 
Poleg tega so makrociklična sredstva povezana z majhnim tveganjem NSF.
Population-specific indication for Multihance 
Indikacija sredstva Multihance za določeno populacijo
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. 
Ravni so 20 tednov ostale nizke, do 50. tedna pa ni bilo ugotovljeno dodatno znižanje, kar kaže, da se gadolinij v možganih morda zadrži dolgoročno, pri čemer ni dokazov, da bi v enem letu izginil.
However, these studies have significant limitations (e.g. studies could not exclude exposure to linear GdCA prior to study period) and do therefore not establish a causal relationship with macrocyclic agents. 
Vendar pa so te študije precej omejene (študije na primer niso mogle izključiti izpostavljenosti linearnemu sredstvu GdCA pred obdobjem študije), zato ne ugotavljajo vzročne povezanosti z makrocikličnimi sredstvi.
Prolonged elimination time in patients with renal impairment and release of gadolinium from GdCAs are the main factors that contribute to the development of NSF. 
Podaljšani čas izločanja pri bolnikih z ledvično okvaro in sproščanje gadolinija iz sredstev GdCA sta glavna dejavnika, ki prispevata k razvoju NSF.
Besides, as the variation was concluded in parallel to the PRAC review, the variation conclusions were understood as being without prejudice of the outcome of the ongoing EU review. 
Ker je bila sprememba zaključena hkrati s pregledom odbora PRAC, se je razumelo, da zaključki v zvezi s spremembo ne vplivajo na rezultat pregleda, ki je potekal na ravni EU.
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. 
Poleg tega v kartoteki, ki jo za bolnika vodi radiolog, morda ne bi bila v celoti zabeležena pogostnost in časovni razpored uporabe ali pa ta ne bi bila dostopna naslednjemu radiologu ali splošnemu zdravniku, s katerim bi bolnik stopil v stik, ker bi večkrat spremenil radiologa/splošnega zdravnika zaradi spremembe bivališča ali iz drugih razlogov.
The study also found that changes in signal intensity were strongly correlated with the amount of gadolinium detected by ICP-MS. 
V študiji je bilo tudi ugotovljeno, da so bile spremembe intenzivnosti signala močno povezane s količino gadolinija, ugotovljenega z ICP-MS.
1 ICP-MS: Inductively coupled plasma mass spectrometry 
1 ICP-MS: masna spektrometrija z induktivno sklopljeno plazmo.
On 9 March 2016, the European Commission triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of gadolinium containing medicinal products and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked. 
Evropska komisija je 9. marca 2016 na podlagi farmakovigilančnih podatkov sprožila napotitev v skladu s členom 31 Direktive 2001/83/ES in odbor PRAC zaprosila, naj oceni vpliv navedenih pomislekov na razmerje med koristmi in tveganji, ki vsebujejo gadolinij, ter izda priporočilo o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno umakniti ali ukiniti.
These conclusions are in line with the opinion of the experts expressed at the ad hoc expert meeting, i.e. that linear and macrocyclic agents can be used interchangeably for cardiac imaging and that there is no established or perceived difference in their clinical utility. 
Ti zaključki so v skladu z mnenjem strokovnjakov, izraženim na ad hoc strokovnem sestanku, in sicer, da je mogoče linearna in makrociklična sredstva pri slikanju srca uporabljati zamenljivo ter da ni bila ugotovljena ali zaznana razlika v njihovi klinični koristnosti.
With these uncertainties, conclusions on different or similar behaviour of the different contrast agents studied by McDonald et al. are not possible. 
Glede na te negotovosti ni mogoče sprejeti zaključkov o različnem ali podobnem obnašanju različnih kontrastnih sredstev, ki so jih proučili McDonald idr.
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. 
Opazovalne klinične študije bi imele omejitve, ker metode merjenja neželenih učinkov na kognitivne ali motorično nevrološke sposobnosti morda v standardnih metodah niso zajete ali se ne merijo redno, zato morda ne bi bile zanesljive in veljavne.
A number of studies have shown a correlation between the number of exposures to linear GdCAs and the signal intensity changes. 
Več študij je dokazalo povezavo med številom izpostavljenosti linearnim sredstvom GdCA in spremembami intenzivnosti signala.
Impact of renal impairment 
Učinek ledvične okvare