natgillin/translations-raw huggingface dataset:
Moxifloxacin Actavis Moxifloxacin Hydrochloride 400mg Tablet
Moxifloxacin Actavis Moksifloksacin hidroklorid 400 mg tableta
Ciprofloxacin Generics Ciprofloxacin 500mg Tablet
Ciprofloxacin Generics Ciprofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 250mg Tablet
Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Ciprofloksacin hidroklorid 250 mg tableta
Levofloxacina Tecnigen Levofloxacin 250mg Tablet
Levofloxacina Tecnigen Levofloksacin 250 mg tableta Filmom obložena tableta
Moxifloxacino Tevagen Moxifloxacin 400mg Tablet
Moxifloxacino Tevagen Moksifloksacin 400 mg tableta Filmom obložena tableta
Levofloxacine Hospira Levofloxacin 250mg/50 Ml
Levofloxacin Hospira Levofloksacin 250 mg/50 ml
Norfloxacino Normon Norfloxacin 400mg Tablet
Norfloxacino Normon Norfloksacin 400 mg tableta Obložena tableta Peroralna primjena
Ciprofloxacin Lactate 2.54mg/Ml
Ciprofloksacin laktat 2,54 mg/ml
Ciprofloxacino Mabo Ciprofloxacin 750mg Tablet
Ciprofloxacino Mabo Ciprofloksacin 750 mg tableta Filmom obložena tableta
Ciprofloxacin Hydrochloride 500mg Tablet
Ciprofloksacin hidroklorid 500 mg tableta
Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Ciprofloxacino Cinfa Ciprofloksacin hidroklorid monohidrat 500 mg tableta
Ciprofloxacine Cristers Ciprofloxacin 500mg Tablet
Ciprofloxacine Cristers Ciprofloksacin 500 mg tableta Filmom obložena tableta
Norfloxacino Sandoz Norfloxacin 400mg Tablet
Norfloxacino Sandoz Norfloksacin 400 mg tableta Filmom obložena tableta
Moxifloxacina Torrent Moxifloxacin 400mg Tablet
Moxifloxacina Torrent Moksifloksacin 400 mg tableta Filmom obložena tableta
Norfloxacina Sandoz Norfloxacin 400mg Tablet
Norfloxacina Sandoz Norfloksacin 400 mg tableta Filmom obložena tableta
Ciprofloxacin Hydrochloride 291mg Tablet
Ciprofloksacin hidroklorid 291 mg tableta
Levofloxacina Generis Levofloxacin Hemihydrate 512.46mg Tablet
Levofloxacina Generis Levofloksacin hemihidrat 512,46 mg tableta
Moxifloxacin Aurobindo Moxifloxacin Hydrochloride 436.32mg Tablet
Aurobindo Pharma Gmbh Moxifloxacin Aurobindo Moksifloksacin hidroklorid 436,32 mg tableta
Levofloxacin 512,46mg Tablet Film-Coated Tablet
Levofloksacin 512,46 mg tableta
Levofloxacino Pensa Levofloxacin 500mg Tablet
Levofloxacino Pensa Levofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacin Hydrochloride 582mg Tablet
Ciprofloksacin hidroklorid 582 mg tableta
Ciprofloxacina Ciclum Ciprofloxacin 500mg Tablet
Ciprofloxacina Ciclum Ciprofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacină Arena Ciprofloxacin 250mg Tablet
Ciprofloxacină Arena Ciprofloksacin 250 mg tableta Filmom obložena tableta
Ciprofloxacin Lactate 254.4mg Vial
Ciprofloksacin laktat 254,4 mg bočica
Levofloxacina Zentiva Levofloxacin 500mg Tablet
Levofloxacina Zentiva Levofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacin Mylan Ciprofloxacin 100mg Tablet
Ciprofloxacin Mylan Ciprofloksacin 100 mg tableta Filmom obložena tableta
Ciprofloxacin Heumann Ciprofloxacin 500mg Tablet
Ciprofloxacin Heumann Ciprofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacine Zydus Ciprofloxacin 250mg Tablet
Ciprofloxacine Zydus Ciprofloksacin 250 mg tableta Filmom obložena tableta
Ciprofloxacino Tevagen Ciprofloxacin 250mg Tablet
Ciprofloxacino Tevagen Ciprofloksacin 250 mg tableta Filmom obložena tableta
Norfloxacine Sandoz Norfloxacin 400mg Tablet
Norfloxacine Sandoz Norfloksacin 400 mg tableta Filmom obložena tableta
Levofloxacin Liconsa Levofloxacin 500mg Tablet
Levofloxacin Liconsa Levofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacine Arrow Ciprofloxacin 500mg Tablet
Ciprofloxacine Arrow Ciprofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacin Heumann Ciprofloxacin 250mg Tablet
Ciprofloxacin Heumann Ciprofloksacin 250 mg tableta Filmom obložena tableta
Levofloxacin Hemihydrate 512.46mg Vial
Levofloksacin hemihidrat 512,46 mg bočica
Ciprofloxacine Arrow Ciprofloxacin 250mg Tablet
Ciprofloxacine Arrow Ciprofloksacin 250 mg tableta Filmom obložena tableta
Levofloxacina Ciclum Levofloxacin 250mg Tablet
Levofloxacina Ciclum Levofloksacin 250 mg tableta Filmom obložena tableta
Moxifloxacine Mylan Moxifloxacin Hydrochloride 400mg Tablet
Moxifloxacine Mylan Moksifloksacin hidroklorid 400 mg tableta
Ciprofloxacina Ciclum Ciprofloxacin 250mg Tablet
Ciprofloxacina Ciclum Ciprofloksacin 250 mg tableta Filmom obložena tableta
Norfloxacin 400mg Tablet
Norfloksacin 400 mg tableta Filmom obložena tableta
Ciprofloxacina Tolife Ciprofloxacin 250mg Tablet
Ciprofloxacina Tolife Ciprofloksacin 250 mg tableta Filmom obložena tableta
Moxifloxacine Sandoz Moxifloxacin 400mg Tablet
Moxifloxacin Sandoz Moksifloksacin hidroklorid 400 mg tableta
Ciprofloxacin Lactate 508.8mg Vial
Ciprofloksacin laktat 508,8 mg bočica
Levofloxacino Normon Levofloxacin Hemihydrate 513mg Tablet
Levofloxacino Normon Levofloksacin hemihidrat 513 mg tableta
Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Ciprofloxacina Sandoz Ciprofloksacin hidroklorid monohidrat 500 mg tableta
Levofloxacina Farmoz Levofloxacin 500mg Tablet
Levofloxacina Farmoz Levofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacin Generics Ciprofloxacin 750mg Tablet
Ciprofloxacin Generics Ciprofloksacin 750 mg tableta Filmom obložena tableta
Moxifloxacina Generis Moxifloxacin 400mg Tablet
Moxifloxacina Generis Moksifloksacin 400 mg tableta Filmom obložena tableta
Levofloxacina Pensa Levofloxacin 250mg Tablet
Levofloxacina Pensa Levofloksacin 250 mg tableta Filmom obložena tableta
Moxifloxacina Bloza Bluepharma - Indústria Farmacêutica
Moxifloxacina Bloza Bluepharma
Moxifloxaxino Normon Moxifloxacin 400mg Units
Moxifloxaxino Normon Moksifloksacin 400 mg jedinice Filmom obložena tableta
Ciprofloxacin Milpharm Ciprofloxacin 250mg Tablet
Ciprofloxacin Milpharm Ciprofloksacin 250 mg tableta Filmom obložena tableta
Ciprofloxacine Arrow Ciprofloxacin 750mg Tablet
Ciprofloxacine Arrow Ciprofloksacin 750 mg tableta Filmom obložena tableta
Ciprofloxacina Tolife Ciprofloxacin 500mg Tablet
Ciprofloxacina Tolife Ciprofloksacin 500 mg tableta Filmom obložena tableta
Levofloxacina Accord Levofloxacin Hemihydrate 256.23mg Tablet
Accord Healthcare Limited Levofloxacina Accord Levofloksacin hemihidrat 256,23 mg tableta
Ciprofloxacina Tolife Ciprofloxacin 750mg Tablet
Ciprofloxacina Tolife Ciprofloksacin 750 mg tableta Filmom obložena tableta
Moxifloxacina Hetero Moxifloxacin 400mg Tablet
Moxifloxacina Hetero Moksifloksacin 400 mg tableta Filmom obložena tableta
Levofloxacine Zydus Levofloxacin 500mg Tablet
Levofloxacine Zydus Levofloksacin 500 mg tableta Filmom obložena tableta
Levofloxacin Arcana Levofloxacin 250mg/50 Ml
Arcana Arzneimittel Gmbh Levofloxacin Arcana Levofloksacin 250 mg/50 ml
Levofloxacina Pensa Levofloxacin 500mg Tablet
Levofloxacina Pensa Levofloksacin 500 mg tableta Filmom obložena tableta
Ranbaxy Pharmacie Generiques Norfloxacine Ranbaxy Norfloxacin 400mg Tablet
Norfloxacine Ranbaxy Norfloksacin 400 mg tableta Filmom obložena tableta
Moxifloxacino Hetero Moxifloxacin 400mg Tablet
Moxifloxacino Hetero Moksifloksacin 400 mg tableta Filmom obložena tableta
Levofloxacino Sandoz Levofloxacin 500mg Tablet
Levofloxacino Sandoz Levofloksacin 500 mg tableta Filmom obložena tableta
Levofloxacina Zentiva Levofloxacin 250mg Tablet
Levofloxacina Zentiva Levofloksacin 250 mg tableta Filmom obložena tableta
Ciprofloxacin Axcount Ciprofloxacin 500mg Tablet
Axcount Generika Gmbh Ciprofloxacin Axcount Ciprofloksacin 500 mg tableta Filmom obložena tableta
Levofloxacino Tecnigen Levofloxacin 500mg Tablet
Levofloxacino Tecnigen Levofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacin Milpharm Ciprofloxacin 750mg Tablet
Ciprofloxacin Milpharm Ciprofloksacin 750 mg tableta Filmom obložena tableta
Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 873mg Tablet
Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloksacin hidroklorid 873 mg tableta
Ciprofloxacin Milpharm Ciprofloxacin 500mg Tablet
Ciprofloxacin Milpharm Ciprofloksacin 500 mg tableta Filmom obložena tableta
Solution For Infusion Infusion
Otopina za infuziju Infuzija
Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 291mg Tablet
Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloksacin hidroklorid 291 mg tableta
Levofloxacino Almus Levofloxacin 500mg Tablet
Levofloxacino Mabo Levofloksacin hemihidrat 500 mg tableta
Ciprofloxacina Tecnigen Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Ciprofloxacina Krka Ciprofloksacin hidroklorid monohidrat 582 mg tableta
Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 582mg Tablet
Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloksacin hidroklorid 582 mg tableta
Ciprofloxacina Tecnigen Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Ciprofloxacina Krka Ciprofloksacin hidroklorid monohidrat 291 mg tableta
Ciprofloxacin Actavis Ciprofloxacin 500mg Tablet
Ciprofloxacin Actavis Ciprofloksacin 500 mg tableta Filmom obložena tableta
Levofloxacine Mylan Levofloxacin 250mg Tablet
Levofloxacina Mylan Levofloksacin 250 mg tableta Filmom obložena tableta
Levofloxacine Sandoz Levofloxacin 500mg Tablet
Levofloxacine Sandoz Levofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacina Mylan Ciprofloxacin 750mg Tablet
Ciprofloxacina Mylan Ciprofloksacin 750 mg tableta Filmom obložena tableta
Ranbaxy Pharmacie Generiques Ciprofloxacine Ranbaxy Ciprofloxacin 250mg Tablet
Axcount Generika Gmbh Ciprofloxacin Axcount Ciprofloksacin 250 mg tableta Filmom obložena tableta
Moxifloxacin 400mg Tablet
Moxifloxacine Mylan Moksifloksacin 400 mg tableta Tableta
Levofloxacine Sandoz Levofloxacin 250mg Tablet
Levofloxacina Sandoz Levofloksacin 250 mg tableta Filmom obložena tableta
Ciprofloxacina Sandoz Ciprofloxacin 750mg Tablet
Ciprofloxacina Sandoz Ciprofloksacin 750 mg tableta Filmom obložena tableta
Levofloxacine Jubilant Levofloxacin Hemihydrate 512.46mg Tablet
Levofloxacine Pch Levofloksacin hemihidrat 512,46 mg tableta
Levofloxacin Mylan Levofloxacin 500mg Tablet
Levofloxacino Mylan Levofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacin Lactate 254mg/100 Ml
Ciprofloksacin laktat 254 mg/100 ml
Levofloxacin Actavis Levofloxacin Hemihydrate 250mg Tablet
Levofloxacin Actavis Levofloksacin 250 mg tableta Filmom obložena tableta
Ciprofloxacina Actavis Ciprofloxacin 500mg Tablet
Ciprofloxacina Actavis Ciprofloksacin 500 mg tableta Filmom obložena tableta
Levofloxacin Actavis Levofloxacin 250mg Tablet
Levofloxacina Actavis Levofloksacin 250 mg tableta Filmom obložena tableta
Levofloxacina Tecnigen Levofloxacin 500mg Tablet
Levofloxacina Tecnigen Levofloksacin 500 mg tableta Filmom obložena tableta
Ciprofloxacino Sandoz Ciprofloxacin 500mg Tablet
Ciprofloxacino Sandoz Ciprofloksacin 500 mg tableta Filmom obložena tableta
Moxifloxacina Ciclum Moxifloxacin 400mg Tablet
Moxifloxacina Ciclum Moksifloksacin 400 mg tableta Filmom obložena tableta
Ciprofloxacine Sandoz Ciprofloxacin 750mg Tablet
Ciprofloxacine Sandoz Ciprofloksacin 750 mg tableta Filmom obložena tableta
Ciprofloxacin Mylan Ciprofloxacin 750mg Tablet
Ciprofloxacin Mylan Ciprofloksacin 750 mg tableta Filmom obložena tableta
Ciprofloxacin Sandoz Ciprofloxacin 750mg Tablet
Ciprofloxacin Sandoz Ciprofloksacin 750 mg tableta Filmom obložena tableta
Levofloxacine Jubilant Levofloxacin Hemihydrate 256.23mg Tablet
Levofloxacine Pch Levofloksacin hemihidrat 256,23 mg tableta
Moxifloxacin Mylan Moxifloxacin 400mg Tablet
Moxifloxacino Mylan Moksifloksacin 400 mg tableta Filmom obložena tableta
Levofloxacina Farmoz Levofloxacin 250mg Tablet
Levofloxacina Farmoz Levofloksacin 250 mg tableta Filmom obložena tableta
Levofloxacin Mylan Levofloxacin 250mg Tablet
Levofloxacin Mylan Levofloksacin 250 mg tableta Filmom obložena tableta
Levofloxacina Sandoz Levofloxacin 500mg Tablet
Levofloxacina Sandoz Levofloksacin 500 mg tableta Filmom obložena tableta
Levofloxacino Stada Levofloxacin 500mg Tablet
Levofloxacino Stada Levofloksacin 500 mg tableta Filmom obložena tableta
Oral Suspension
Oralna suspenzija Peroralna primjena
Moxifloxacin Sandoz Moxifloxacin 400mg Tablet
Moxifloxacin Sandoz Moksifloksacin 400 mg tableta Filmom obložena tableta
Levofloxacin Accord Levofloxacin 500mg/100 Ml
Accord Healthcare Limited Levofloxacin Accord Levofloksacin 500 mg/100 ml
Ciprofloxacina Actavis Ciprofloxacin 250mg Tablet
Ciprofloxacina Actavis Ciprofloksacin 250 mg tableta Filmom obložena tableta
Ciprofloxacina Mylan Ciprofloxacin 250mg Tablet
Ciprofloxacina Mylan Ciprofloksacin 250 mg tableta Filmom obložena tableta
All animals should have had water from the same source
Sve životinje trebale su dobiti vodu iz istog izvora
Fatalities are extremely rare.
Pogubni slučajevi iznimno su rijetki.
The authors could not provide a sound explanation for this.
Autori nisu mogli pružiti razumno objašnjenje za to.
Therefore this statement is not maintained.
Stoga se ta izjava ne zadržava.
These effects might be delayed and subtle.
Ti učinci mogu biti odgođeni i suptilni.
Other safety aspects
Drugi sigurnosni aspekti
Higher relaxivity of Multihance
Veći relaksivitet Multihancea
In accordance with Article 107k of Directive 2001/83/EC, the CHMP considered the PRAC recommendation adopted on 6 July 2017.
U skladu s člankom 107. točkom (k) Direktive 2001/83/EZ, CHMP razmotrio je PRAC-ovu preporuku donesenu 6. srpnja 2017.
In addition, the repeated use of these products is most unlikely.
Nadalje, ponovljena uporaba tih lijekova nije vjerojatna.
In view of the above, the PRAC concluded that:
Uzimajući u obzir prethodno navedeno, PRAC zaključuje sljedeće:
Neither would the introduction of educational material address this issue.
Taj problem ne bi riješilo ni uvođenje edukativnih materijala.
Therefore the condition should not mention “including the brains in human.”
Stoga uvjet ne treba sadržavati izraz „uključujući ljudski mozak”.
Particularly, it was stated that the influence on patient management was not directly demonstrated by the study results.
Konkretno, utvrđeno je da utjecaj na upravljanje bolesnikom nije izravno pokazan u rezultatima ispitivanja.
The experts at the ad-hoc expert meeting shared these same views.
Stručnjaci na ad hoc sastanku donijeli su isto mišljenje.
In case such studies were however to be carried out, patients would bear the risks as long as ongoing research is not completed.
U slučaju da se takva ispitivanja ipak provedu, bolesnici bi snosili rizike sve dok se ispitivanje ne dovrši.
The long-term clinical consequences of such gadolinium retention are currently unknown.
Dugoročne kliničke posljedice takvog zadržavanja gadolinija trenutačno nisu poznate.
In general, appropriate medications, equipment and staff experienced in the management of hypersensitivity reactions can be expected in any radiological practice.
Općenito gledajući, odgovarajući lijekovi, oprema i osoblje s iskustvom u upravljanju reakcijama preosjetljivosti može se očekivati u bilo kojoj radiološkoj praksi.
Detailed conclusions from the meeting can be found in the enclosure 11 to the PRAC assessment report.
Detaljni zaključci sa sastanka dostupni su u prilogu 11. u PRAC-ovom izvješću o procjeni.
This clearly indicates that potential dechelation in the body is a recognised phenomenon.
To jasno pokazuje da je moguća dekelacija u tijelu poznati fenomen.
Although in patients with a history of drug allergy the reaction risk might be increased, the risk is still very low.
Iako se u bolesnika s povijesti alergija na lijekove rizik od reakcije može povećati, rizik je i dalje vrlo malen.
The linear compounds therefore particularly persist in the brain.
Linearni spojevi stoga se posebno zadržavaju u mozgu.
However, it demonstrates the complexity and difficulties associated with the objective of analysing potential neurological effects.
Međutim, pokazuje složenost i poteškoće povezane s analizom mogućih neuroloških učinaka.
Premedication with antihistamines and corticosteroids could also be applied.
Može se primijeniti premedikacija antihistaminicima i kortikosteroidima.
The implemented risk minimisation measures appear to be effective based on annual reviews of spontaneous case reports.
Čini se da su provedene mjere za smanjenje rizika djelotvorne na temelju godišnjih ocjena izvješća o pojedinačnom slučaju.
With these uncertainties, conclusions on different or similar behaviour of the different contrast agents studied by McDonald et al. are not possible.
Uz te nesigurnosti, zaključke o različitom ili sličnom ponašanju različitih kontrastnih sredstava koje su ispitivali McDonald i dr. nije moguće donijeti.
The vast majority of these reactions are non-serious, with a very low percentage of patients experiencing severe hypersensitivity reactions.
Većina tih reakcija nije ozbiljna, pri čemu vrlo mali postotak bolesnika doživi teške reakcije preosjetljivosti.
Macrocyclic GdCAs
Makrociklički GdCA-ovi
Interventional clinical studies comparing the different products could be considered unethical.
Intervencijska klinička ispitivanja koja uspoređuju razne lijekove mogla bi se smatrati neetičnima.
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.
PRAC je uzeo u obzir da je zakazan 2. ad hoc sastanak stručne skupine radi rješavanja nekih aspekata koji su bili dio detaljnih razloga koje su podnijeli Bracco i GE Healthcare.
Such long-term safety studies are unlikely to be feasible within reasonable period of time.
Nije vjerojatno da će takva dugoročna ispitivanja biti provediva u razumnom vremenskom roku.
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.
Ta područja sudjeluju u reguliranju dobrovoljnih i nedobrovoljnih pokreta; štetni učinci mogu uključivati ataksiju, drhtavicu i druge poremećaje kretanja.
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).
Vjeruje se da je to razdvajanje povezano s razlikama u stabilnosti kompleksa raznih vrsta GdCA sredstava (Spencer i dr. 1997.).
Despite worldwide use serious adverse reactions are rare; urticaria is the most common manifestation.
Unatoč uporabi diljem svijeta, štetne reakcije su rijetke, urtikarija je najčešća nuspojava.
National assessment
Nacionalna procjena
Overall, the experts expressed divergent views concerning the risk minimisation measures.
Stručnjaci su uglavnom iznijeli različita mišljenja u vezi s mjerama za smanjenje rizika.
They are used for contrast enhancement in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA).
Koriste se za povećanje kontrasta pri snimanju magnetskom rezonancijom (MRI) i pri magnetskoj angiografiji (MRA).
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.
U pogledu upućivanja na prethodnu procjenu provedenu na nacionalnoj razini (varijacija vrste II. za proširenje indikacije lijeka Multihance UK/H/0234/001-002/II/038) valja napomenuti da je procjena primjene varijacije imala područje primjene drugačije od onog u postupku upućivanja iz članka 31. te se posljedično ta dva postupka temelje na različitim skupovima podataka; stoga je moguće opravdati drugačiji ishod.
Additionally, it is not possible to define a period of time during which no potential adverse effect would have time to manifest.
Nadalje, nije moguće odrediti vremensko razdoblje tijekom kojeg bi se mogući štetni učinci mogli pokazati.
• 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.
• Oblik i veličina T1 signala znatno se razlikuje od oblika signala prijavljenog u dvije nedavne publikacije (Jost i dr., 2016. i Robert i dr., 2015.) te nije potpuno jasno odgovara li područje poboljšanog signala zaista DN-u ili drugim područjima u mozgu.
There is no strong evidence of a true difference in the rate of hypersensitivity reactions or other acute reactions associated with GdCAs or of a difference in the rate of ADRs with a fatal outcome across the class.
Ne postoje jaki dokazi o pravoj razlici u stopi reakcija preosjetljivosti ili drugih akutnih reakcija povezanih s GdCA-ovima ili razlici u stopi ADR-ova sa smrtnim ishodom u cijelom razredu.
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.
Štoviše, podaci o učestalosti i vremenu primjene možda nisu u potpunosti zabilježeni u radiološkom kartonu bolesnika i/ili nisu dostupni budućem radiologu ili liječniku opće prakse jer je bolesnik promijenio radiologa/liječnika opće prakse nekoliko puta zbog promjene mjesta stanovanja ili drugih razloga.
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.
Osim toga, budući da je varijacija zaključena paralelno s PRAC-ovom ocjenom, smatra se da zaključci o varijaciji ne dovode u pitanje ishod ocjene EU-a koja je u tijeku.
The design of any future clinical study to investigate the long-term safety of GdCAs in patients would require large numbers of patients to have sufficient power to detect small adverse effects on cognition (cognitive disorders) or physical abilities (fine motor skills).
Dizajn bilo kojeg budućeg ispitivanja dugoročne sigurnosti GdCA-ova u bolesnika zahtijeva da veliki broj bolesnika ima dovoljno vještina za otkrivanje malih štetnih učinaka na kognitivne (kognitivni poremećaji) ili fizičke sposobnosti (fine motoričke vještine).
PRAC conclusions on grounds for re-examination
Zaključci PRAC-a o razlozima za ponovnu ocjenu
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.
Nakon donošenja preporuke PRAC-a tijekom sastanka u ožujku 2017., dva nositelja odobrenja za stavljanje u promet (Bracco i GE Healthcare) izrazila su neslaganje s početnom preporukom PRAC-a.
A number of studies have shown a correlation between the number of exposures to linear GdCAs and the signal intensity changes.
Brojna ispitivanja pokazala su vezu između broja izlaganja linearnim GdCA-ovima i promjene u intenzitetu signala.
• the dynamic phase, for which all the authorised GdCAs can provide enhancement of liver imaging,
• dinamična faza u kojoj svi odobreni GdCA-ovi mogu poboljšati snimanje jetre,
Enhancement after gadobenate dimeglumine (Multihance) or gadopentetate dimeglumine (Magnevist) appeared more progressively compared with gadodiamide.
Poboljšanje nakon primjene gadobenata dimeglumina (Multihance) ili gadopentetata dimeglumina (Magnevist) činilo se progresivnije u usporedbi s gadodiamidom.
These observations leave the possibility that the method used for the Gd determination is unreliable under certain circumstances.
Ta zapažanja ostavljaju mogućnost da je metoda koja je korištena za utvrđivanje gadolinija nepouzdana u određenim okolnostima.
Benefit/risk balance
Omjer koristi/rizika
The regions of the brain with the greatest potential for brain accumulation are the dentate nucleus and globus pallidus.
Područja mozga koja imaju najveći potencijal za taloženje na mozgu su dentatni nukleus i globus pallidus.
Toxicity of non-chelated gadolinium
Toksičnost nekeliranog gadolinija