FrancophonIA/ELRC3.0 huggingface dataset:
English: Ciprofloxacin Milpharm Ciprofloxacin 500mg Tablet
Slovenian: Ciprofloxacin Milpharm ciprofloksacin 500 mg tableta filmsko obložena tableta
English: Moxifloxacin Aurobindo Moxifloxacin Hydrochloride 436.32mg Tablet
Slovenian: Moxifloxacin Aurobindo moksifloksacinijev klorid 436,32 mg tableta
English: Moxifloxacin Hydrochloride 437mg/250 Ml
Slovenian: Moxifloxacin Stada moksifloksacinijev klorid 437 mg/250 ml
English: Levofloxacina Pensa Levofloxacin 500mg Tablet
Slovenian: Levofloxacino Pensa levofloksacin 500 mg tableta filmsko obložena tableta
English: Ciprofloxacina Generis Ciprofloxacin Hydrochloride 291mg Tablet
Slovenian: Ciprofloxacina Generis ciprofloksacinijev klorid 291 mg tableta
English: Ciprofloxacin Hydrochloride 873mg Tablet
Slovenian: ciprofloksacinijev klorid 873 mg tableta
English: Ciprofloxacine Sandoz Ciprofloxacin Hydrochloride 250mg Tablet
Slovenian: Ciprofloxacine Sandoz ciprofloksacinijev klorid 250 mg tableta
English: Ciprofloxacine Arrow Ciprofloxacin 250mg Tablet
Slovenian: Ciprofloxacine Arrow ciprofloksacin 250 mg tableta filmsko obložena tableta
English: Levofloxacin Hemihydrate 5mg/Ml
Slovenian: Levoxacin levofloksacin hemihidrat 5 mg/ml
English: Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 500mg Tablet
Slovenian: Arcana Arzneimittel Gmbh Ciprofloxacin Arcana ciprofloksacinijev klorid 500 mg tableta
English: Ciprofloxacina Ranbaxy Ciprofloxacin Hydrochloride 500mg Tablet
Slovenian: Ciprofloxacina Ranbaxy ciprofloksacinijev klorid 500 mg tableta
English: Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Slovenian: Ciprofloxacina Sandoz ciprofloksacinijev klorid monohidrat 500 mg tableta
English: Ciprofloxacin Hydrochloride Monohydrate 291.5µg Tablet
Slovenian: Ciproten ciprofloksacinijev klorid monohidrat 291,5 mg tableta
English: Ciprofloxacin Mylan Ciprofloxacin 500mg Tablet
Slovenian: Ciprofloxacine Mylan ciprofloksacinijev klorid 500 mg tableta
English: Levofloxacin Beximco Levofloxacin 250mg Tablet
Slovenian: Levofloxacine Beximco levofloksacin 250 mg tableta filmsko obložena tableta
English: Levofloksacin B. Braun Levofloxacin 5mg/Ml
Slovenian: Levofloksacin B. Braun levofloksacin 5 mg/ml
English: Levofloxacine Zydus Levofloxacin 500mg Tablet
Slovenian: Levofloxacine Zydus levofloksacin 500 mg tableta filmsko obložena tableta
English: Cipro Inf
Slovenian: Kg Cipro
English: Ciprofloxacina Generis Ciprofloxacin 500mg/5 Ml
Slovenian: Ciprofloxacina ciprofloksacin 500 mg
English: Norfloxacine Sandoz Norfloxacin 400mg Tablet
Slovenian: Norfloxacine Sandoz norfloksacin 400 mg tableta filmsko obložena tableta
English: HOLSTEN PHARMA GMBH Ciprofloxacin Real
Slovenian: HOLSTEN PHARMA GMBH Ciprofloxacin cirpofloksacin 500 mg
English: Levofloxacin Hemihydrate 5.12mg/Ml
Slovenian: Levofloxacine Eg levofloksacin hemihidrat 5,12 mg/ml
English: Levofloxacine Beximco Levofloxacin 500mg Tablet
Slovenian: Levofloxacine Beximco levofloksacin 500 mg tableta filmsko obložena tableta
English: Moxifloxacina Aurovitas Moxifloxacin Hydrochloride 436.32mg Tablet
Slovenian: Moxifloxacina Aurovitas moksifloksacinijev klorid 436,32 mg tableta
English: Levofloxacin Hemihydrate 500mg/100 Ml
Slovenian: Talerin levofloksacin hemihidrat 500 mg/100 ml
English: Ciprofloxacina Tolife Ciprofloxacin Hydrochloride 500mg Tablet
Slovenian: Ciprofloxacina Tolife ciprofloksacinijev klorid 500 mg tableta
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 873mg Tablet
Slovenian: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med ciprofloksacinijev klorid 873 mg tableta
English: Pefloxacin 400mg Tablet
Slovenian: Abaktal pefloksacinijev mesilat 400 mg tableta
English: Ciprofloxacina Cinfa Ciprofloxacin 250mg Tablet
Slovenian: Ciprofloxacina Cinfa ciprofloksacin 250 mg tableta obložena tableta
English: Levofloxacina Aristo Levofloxacin 250mg Tablet
Slovenian: Levofloxacina Aristo levofloksacin 250 mg tableta filmsko obložena tableta
English: Pefloxacin Mesilate 400mg Tablet
Slovenian: Mofinacin moksifloksacin 400 mg tableta
English: Levofloxacina Generis Levofloxacin Hemihydrate 512.46mg Tablet
Slovenian: Levofloxacina Generis levofloksacin hemihidrat 512,46 mg tableta
English: Ciprofloxacina Cinfa Ciprofloxacin 750mg Tablet
Slovenian: Ciprofloxacina Cinfa ciprofloksacin 750 mg tableta obložena tableta
English: Moxifloxacino Actavis Moxifloxacin Hydrochloride 400mg Tablet
Slovenian: Moxifloxacino Actavis moksifloksacinijev klorid 400 mg tableta
English: Levofloxacin B. Braun Levofloxacin 5mg/Ml
Slovenian: Levofloxacin B. Braun levofloksacin 5 mg/ml
English: Ciprofloxacino Fresenius Kabi
Slovenian: Ciprofloxacino Ranbaxy
English: Ciprofloxacin Ranbaxy Ciprofloxacin 500mg Tablet
Slovenian: Ciprofloxacin Ranbaxy ciprofloksacin 500 mg tableta filmsko obložena tableta
English: Ciprofloxacin Olainfarm Ciprofloxacin 250mg Tablet
Slovenian: Ciprofloxacin Olainfarm ciprofloksacin 250 mg tableta filmsko obložena tableta
English: Ciprofloxacin Hydrochloride 586mg Tablet
Slovenian: Ciprolon ciprofloksacinijev klorid 586 mg tableta
English: Ciprofloxacin Milpharm Ciprofloxacin 750mg Tablet
Slovenian: Ciprofloxacin Milpharm ciprofloksacin 750 mg tableta filmsko obložena tableta
English: Rufloxacin Hydrochloride 200mg Tablet
Slovenian: Monos rufloksacinijev klorid 200 mg tableta
English: Levofloxacino Tecnigen Levofloxacin 500mg Tablet
Slovenian: Levofloxacino Tecnigen levofloksacin 500 mg tableta filmsko obložena tableta
English: Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 750mg Tablet
Slovenian: Ciprofloxacino Cinfa ciprofloksacinijev klorid monohidrat 750 mg tableta obložena tableta
English: Ciprofloxacina Ciclum Ciprofloxacin 250mg Tablet
Slovenian: Ciprofloxacina Ciclum ciprofloksacin 250 mg tableta filmsko obložena tableta
English: Ciprofloxacina Tolife Ciprofloxacin 250mg Tablet
Slovenian: Ciprofloxacina Tolife ciprofloksacin 250 mg tableta filmsko obložena tableta
English: Ciprofloxacin Milpharm Ciprofloxacin 250mg Tablet
Slovenian: Ciprofloxacin Milpharm ciprofloksacin 250 mg tableta filmsko obložena tableta
English: Ciprofloxacin Generics Ciprofloxacin 750mg Tablet
Slovenian: Ciprofloxacin Generics ciprofloksacin 750 mg tableta filmsko obložena tableta
English: Ciprofloxacin Hydrochloride 873.3mg Tablet
Slovenian: ciprofloksacinijev klorid 873,24 mg tableta
English: Ciprofloxacino Sandoz Ciprofloxacin 500mg Tablet
Slovenian: Ciprofloxacino Sandoz ciprofloksacin 500mg tableta filmsko obložena tableta
English: Ciprofloxacin Hydrochloride 291.19mg Tablet
Slovenian: Cifran ciprofloksacinijev klorid 291,19 mg tableta
English: Belgium Teva Pharma Belgium N.V./S.A Moxifloxacine Teva
Slovenian: Teva Pharma Belgium N.V./S.A Moxifloxacine Teva moksifloksacin 400 mg tableta
English: Levofloxacina Tecnigen Levofloxacin 250mg Tablet
Slovenian: Levofloxacina Tecnigen levofloksacin 250 mg tableta filmsko obložena tableta
English: Ciprofloxacina Cinfa Ciprofloxacin 500mg Tablet
Slovenian: Ciprofloxacina Cinfa ciprofloksacin 500 mg tableta obložena tableta
English: Levofloxacina Zentiva Levofloxacin 250mg Tablet
Slovenian: Levofloxacina Zentiva levofloksacin 250 mg tableta filmsko obložena tableta
English: Ciprofloxacine Zydus Ciprofloxacin 250mg Tablet
Slovenian: Ciprofloxacine Zydus ciprofloksacin 250 mg tableta filmsko obložena tableta
English: Levofloxacine B. Braun Levofloxacin 5mg/Ml
Slovenian: Levofloxacine B. Braun levofloksacin 5 mg/ml
English: Ciprofloxacin Hydrochloride 582.2mg Tablet
Slovenian: ciprofloksacinijev klorid 582,16 mg tableta
English: Moxifloxacin Hydrochloride 436.8mg Tablet
Slovenian: Moxifloxacina Cinfa moksifloksacinijev klorid 436,8 mg tableta
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 582mg Tablet
Slovenian: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med ciprofloksacinijev klorid 582 mg tableta
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 291mg Tablet
Slovenian: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med ciprofloksacinijev klorid 291 mg tableta
English: Ciprofloxacino Tevagen Ciprofloxacin 250mg Tablet
Slovenian: Ciprofloxacino Tevagen ciprofloksacin 250 mg tableta filmsko obložena tableta
English: Levofloxacino Sandoz Levofloxacin 500mg Tablet
Slovenian: Levofloxacino Sandoz levofloksacin 500 mg tableta filmsko obložena tableta
English: Levofloxacin Arcana Levofloxacin 250mg/50 Ml
Slovenian: Arcana Arzneimittel Gmbh Levofloxacin Arcana levofloksacin 250 mg/50 ml
English: Levofloxacin Aurobindo Levofloxacin 500mg Tablet
Slovenian: Levofloxacin Aurobindo levofloksacin 500 mg tableta filmsko obložena tableta
English: Ofloxacin 100mg Tablet
Slovenian: Oflox ofloksacin 100 mg tableta filmsko obložena tableta
English: Ranbaxy Pharmacie Generiques Norfloxacine Ranbaxy Norfloxacin 400mg Tablet
Slovenian: Norfloxacine Ranbaxy norfloksacin 400 mg tableta filmsko obložena tableta
English: Ciprofloxacine Mylan Ciprofloxacin 200mg/100 Ml
Slovenian: Ciprofloxacine Mylan ciprofloksacin 200 mg/100 ml raztopina za infundiranje
English: Levofloxacina Accord Levofloxacin Hemihydrate 256.23mg Tablet
Slovenian: Accord Healthcare Limited Levofloxacina Accord levofloksacin hemihidrat 256,23 mg tableta
English: Levofloxacina Actavis Levofloxacin 500mg Tablet
Slovenian: Levofloxacin Actavis Group levofloksacin hemihidrat 500 mg tableta
English: Ciprofloxacina Hikma Ciprofloxacin 200mg/100 Ml
Slovenian: Ciprofloxacina Hikma ciprofloksacin 200 mg/100 ml raztopina za infundiranje
English: Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 250mg Tablet
Slovenian: Portugalska Bluefish Pharmaceuticals Ab Levofloxacina Bluefish levofloksacin 250 mg tableta filmsko obložena tableta
English: Ciprofloxacin Hydrochloride 291.1mg Tablet
Slovenian: Ciprofloxacin ciprofloksacinijev klorid 291,5 mg tableta
English: Intravenous Use
Slovenian: Pot uporabe
English: Levofloksacin B. Braun Levofloxacin 500mg/100 Ml
Slovenian: Levofloksacin B. Braun levofloksacin 500 mg/100 ml
English: Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Slovenian: Ciprofloxacino Cinfa ciprofloksacinijev klorid monohidrat 500 mg tableta obložena tableta
English: Moxifloxacino Sandoz Moxifloxacin 400mg Tablet
Slovenian: Moxifloxacino Sandoz moksifloksacin 400 mg tableta
English: Levofloxacina Tecnigen Levofloxacin 500mg Tablet
Slovenian: Levofloxacina Tecnigen levofloksacin 500 mg tableta filmsko obložena tableta
English: Levofloxacin B. Braun Levofloxacin 500mg/100 Ml
Slovenian: Levofloxacin B. Braun levofloksacin 500 mg/100 ml
English: Levofloxacina Ciclum Levofloxacin 250mg Tablet
Slovenian: Levofloxacina Ciclum levofloksacin 250 mg tableta filmsko obložena tableta
English: Ciprofloxacin Fair-Med Ciprofloxacin Hydrochloride 582mg Tablet
Slovenian: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Healthcare ciprofloksacinijev klorid 582mg tableta
English: Mediolanum Farmaceutici Spa Qari
Slovenian: Mediolanum Farmaceutici Spa Qari rufloksacinijev klorid 200 mg tableta
English: Ciprofloxacin Lactate 2.544mg/Ml
Slovenian: Dilon ciprofloksacinijev laktat 2,544 mg/ml
English: Moxifloxacina Sandoz Moxifloxacin 400mg Tablet
Slovenian: Moxifloxacina Sandoz moksifloksacin 400 mg tableta
English: Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 500mg Tablet
Slovenian: Portugalska Bluefish Pharmaceuticals Ab Levofloxacina Bluefish levofloksacin 500 mg tableta filmsko obložena tableta
English: Levofloxacino B. Braun Levofloxacin 500mg/100 Ml
Slovenian: Levofloxacino B. Braun levofloksacin 500 mg/100 ml
English: Levofloxacine Almus Levofloxacin Hemihydrate 512.46mg Tablet
Slovenian: Levofloxacine Almus levofloksacin hemihidrat 512,46 mg tableta obložena tableta
English: Ciprofloxacina Actavis Ciprofloxacin 500mg Tablet
Slovenian: Ciprofloxacina Actavis ciprofloksacin 500 mg tableta filmsko obložena tableta
English: Ciprofloxacina Mylan Ciprofloxacin 750mg Tablet
Slovenian: Ciprofloxacina Mylan ciprofloksacin 750 mg tableta filmsko obložena tableta
English: Ciprofloxacina Sandoz Ciprofloxacin 750mg Tablet
Slovenian: Ciprofloxacina Sandoz ciprofloksacin 750 mg tableta filmsko obložena tableta
English: Ciprofloxacin Actavis Ciprofloxacin 500mg Tablet
Slovenian: Ciprofloxacin Actavis ciprofloksacin 500 mg tableta filmsko obložena tableta
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 512.46mg Tablet
Slovenian: Levofloxacin levofloksacin hemihidrat 512,46 mg tableta
English: Levofloxacin Mylan Levofloxacin 500mg Tablet
Slovenian: Levofloxacino Mylan levofloksacin 500 mg tableta filmsko obložena tableta
English: Ciprofloxacin Hikma Ciprofloxacin 200mg/100 Ml
Slovenian: Ciprofloxacin Hikma ciprofloksacin 200 mg/100 ml raztopina za infundiranje
English: Ciprofloxacine Alter
Slovenian: Ciprofloxacine Evolugen
English: Ciprofloxacin Hydrochloride 582mg Tablet
Slovenian: Ciprinol ciprofloksacinijev klorid 582 mg tableta
English: Levofloxacina B. Braun Levofloxacin 500mg/100 Ml
Slovenian: Levofloxacina B. Braun levofloksacin 500 mg/100 ml
English: Moxifloxaxino Normon Moxifloxacin 400mg Units
Slovenian: Moxifloxaxino Normon moksifloksacin 400 mg enote filmsko obložena tableta
English: Ciprofloxacine Sandoz Ciprofloxacin 750mg Tablet
Slovenian: Ciprofloxacine Sandoz ciprofloksacin 750 mg tableta filmsko obložena tableta
English: Moxifloxacina Mylan Moxifloxacin 400mg Tablet
Slovenian: Moxifloxacina Mylan moksifloksacin 400 mg tableta
English: Moxifloxacin Sandoz Moxifloxacin 400mg Tablet
Slovenian: Moxifloxacin Sandoz moksifloksacin 400 mg tableta
English: Moxifloxacin Hydrochloride 400mg Tablet
Slovenian: Moxifloxacin Hexal moksifloksacin 400 mg tableta
English: Ciprofloxacin Hydrochloride 500mg Tablet
Slovenian: Ciprofloxacine Alter ciprofloksacinijev klorid 500 mg tableta
English: Ciprofloksacin Sandoz Ciprofloxacin Hydrochloride 500mg Tablet
Slovenian: Ciprofloksacin Sandoz ciprofloksacinijev klorid 500 mg tableta
English: Ciprofloxacin Hydrochloride 250mg Tablet
Slovenian: Cifloxin ciprofloksacinijev klorid 250 mg tableta
English: Ciprofloxacin Sandoz Ciprofloxacin 750mg Tablet
Slovenian: Ciprofloxacin Sandoz ciprofloksacin 750 mg tableta filmsko obložena tableta
English: Moxifloxacine Sandoz Moxifloxacin 400mg Tablet
Slovenian: Moxifloxacine Sandoz moksifloksacin 400 mg tableta
English: Moxifloxacin Actavis Moxifloxacin Hydrochloride 400mg Tablet
Slovenian: Moxifloxacin Actavis moksifloksacinijev klorid 400 mg tableta
English: Levofloxacine Sandoz Levofloxacin 500mg Tablet
Slovenian: Levofloxacine Sandoz levofloksacin 500 mg tableta filmsko obložena tableta
English: Levofloxacine Mylan Levofloxacin 250mg Tablet
Slovenian: Levofloxacina Mylan levofloksacin 250 mg tableta filmsko obložena tableta
English: Ciprofloxacin Hydrochloride 750mg Tablet
Slovenian: Ciprofloxacin Teva ciprofloksacinijev klorid 750 mg tableta
English: Levofloxacine Sandoz Levofloxacin 250mg Tablet
Slovenian: Levofloxacina Sandoz levofloksacin 250 mg tableta filmsko obložena tableta
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 256.23mg Tablet
Slovenian: Levofloxacin levofloksacin hemihidrat 256,23 mg tableta
English: Ciprofloxacin Lactate 2.55mg/Ml
Slovenian: Ufexil ciprofloksacinijev laktat 2,55 mg/ml
English: Levofloxacin Mylan Levofloxacin 250mg Tablet
Slovenian: Levofloxacin Mylan levofloksacin 250 mg tableta filmsko obložena tableta
English: Cooper S.A. Pharmaceuticals Levofloxacin Cooper
Slovenian: Cooper S.A. Pharmaceuticals Levofloxacin Cooper levofloksacin 5 mg/ml
English: Levofloxacina Sandoz Levofloxacin 500mg Tablet
Slovenian: Levofloxacina Sandoz levofloksacin 500 mg tableta filmsko obložena tableta
English: Ciprofloxacin Hydrochloride 528mg Tablet
Slovenian: Megaflox ciprofloksacinijev klorid 528 mg tableta obložena tableta
English: Ciprofloxacina Actavis Ciprofloxacin 750mg Tablet
Slovenian: Ciprofloxacina Actavis ciprofloksacin 750 mg tableta filmsko obložena tableta
English: Ciprofloxacín Sandoz Ciprofloxacin 500mg Tablet
Slovenian: Ciprofloxacín Sandoz ciprofloksacin 500 mg tableta filmsko obložena tableta
English: Ciprofloxacina Mylan Ciprofloxacin 500mg Tablet
Slovenian: Ciprofloxacina Mylan ciprofloksacin 500 mg tableta filmsko obložena tableta
English: Levofloxacin Sandoz Levofloxacin 250mg Tablet
Slovenian: Levoxa levofloksacin hemihidrat 250 mg tableta
English: Levofloxacin Accord Levofloxacin 500mg/100 Ml
Slovenian: Accord Healthcare Limited Levofloxacin Accord levofloksacin 500 mg/100 ml
English: All animals should have had water from the same source
Slovenian: Vse živali bi morale imeti vodo iz istega vira;
English: Therefore this statement is not maintained.
Slovenian: Ta navedba zato ni bila ohranjena.
English: Fatalities are extremely rare.
Slovenian: Smrtni primeri so izjemno redki.
English: Other safety aspects
Slovenian: Drugi varnostni vidiki
English: Neither would the introduction of educational material address this issue.
Slovenian: Tudi uvedba izobraževalnega gradiva ne bi rešila tega vprašanja.
English: The authors could not provide a sound explanation for this.
Slovenian: Avtorji tega niso mogli ustrezno pojasniti.
English: Nephrogenic systemic fibrosis (NSF)
Slovenian: Nefrogena sistemska fibroza (NSF)
English: In addition, the repeated use of these products is most unlikely.
Slovenian: Poleg tega je večkratna uporaba teh izdelkov zelo malo verjetna.
English: Detailed conclusions from the meeting can be found in the enclosure 11 to the PRAC assessment report.
Slovenian: Podrobni zaključki s sestanka so na voljo v prilogi 11 k poročilu odbora PRAC o oceni.
English: Therefore the condition should not mention “including the brains in human.”
Slovenian: V pogoju se zato ne bi smelo navesti „vključno z možgani pri ljudeh“;
English: In view of the above, the PRAC concluded that:
Slovenian: Odbor PRAC je glede na navedeno zaključil, da:
English: Interventional clinical studies comparing the different products could be considered unethical.
Slovenian: Intervencijske klinične študije za primerjavo različnih izdelkov pa bi se lahko štele za neetične.
English: These effects might be delayed and subtle.
Slovenian: Ti učinki so lahko zapozneli in komaj zaznavni.
English: The vast majority of these reactions are non-serious, with a very low percentage of patients experiencing severe hypersensitivity reactions.
Slovenian: Velika večina teh reakcij ni huda, zelo majhen odstotek bolnikov pa ima hude preobčutljivostne reakcije.
English: Such long-term safety studies are unlikely to be feasible within reasonable period of time.
Slovenian: Take študije dolgoročne varnosti verjetno v razumnem času ne bi bile izvedljive.
English: In case such studies were however to be carried out, patients would bear the risks as long as ongoing research is not completed.
Slovenian: Če bi se take študije vseeno izvedle, bi bili bolniki izpostavljeni tveganju do zaključka zadevnih raziskav.
English: The long-term clinical consequences of such gadolinium retention are currently unknown.
Slovenian: Dolgoročne klinične posledice takega zadrževanja gadolinija trenutno niso znane.
English: Additionally, it is not possible to define a period of time during which no potential adverse effect would have time to manifest.
Slovenian: Prav tako ni mogoče opredeliti časovnega obdobja, v katerem bi se morebitni neželeni učinek lahko pokazal.
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.
Slovenian: 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.
English: The linear compounds therefore particularly persist in the brain.
Slovenian: Linearne spojine se torej ohranijo predvsem v možganih.
English: National assessment
Slovenian: Nacionalna ocena
English: Premedication with antihistamines and corticosteroids could also be applied.
Slovenian: Lahko se uporabi tudi premedikacija z antihistaminiki in kotrikosteroidi.
English: However, it demonstrates the complexity and difficulties associated with the objective of analysing potential neurological effects.
Slovenian: Pokazala pa je kompleksnost in težave, povezane s ciljem analizirati morebitne nevrološke učinke;
English: This clearly indicates that potential dechelation in the body is a recognised phenomenon.
Slovenian: To jasno kaže, da je potencialna dekelacija v telesu priznan pojav.
English: Data from the clinical post-mortem studies are heterogeneous and it is therefore difficult to compare the levels.
Slovenian: Podatki iz kliničnih študij post mortem so heterogeni, zato je ravni težko primerjati.
English: Higher relaxivity of Multihance
Slovenian: Višja relaksivnost sredstva Multihance
English: • The practical implementation of these measures is moreover not deemed feasible in a clinical setting.
Slovenian: • Poleg tega praktično izvajanje teh ukrepov v kliničnem okolju ne bi bilo izvedljivo.
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.
Slovenian: 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.
English: Overall, the experts expressed divergent views concerning the risk minimisation measures.
Slovenian: Strokovnjaki so v zvezi z ukrepi za zmanjšanje tveganja na splošno izrazili različna stališča.
English: Although in patients with a history of drug allergy the reaction risk might be increased, the risk is still very low.
Slovenian: Čeprav je morda pri bolnikih z anamnezo alergije na zdravilo tveganje za reakcijo večje, je to tveganje še vedno majhno.
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).
Slovenian: Ta disociacija naj bi bila povezana z razlikami v stabilnosti kompleksov med različnimi vrstami sredstev GdCA (Spencer idr., 1997).
English: Particularly, it was stated that the influence on patient management was not directly demonstrated by the study results.
Slovenian: Posebej je bilo poudarjeno, da rezultati študije niso neposredno pokazali vpliva na obravnavanje bolnika.
English: The MAHs were also requested to update the safety specifications in the Risk Management Plans for these products to reflect these findings.
Slovenian: 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.
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Overall summary of the scientific evaluation by the PRAC Background
Slovenian: Splošni povzetek znanstvenega vrednotenja odbora PRAC Ozadje
English: Feasibility of clinical studies
Slovenian: Izvedljivost kliničnih študij