FrancophonIA/ELRC3.0 huggingface dataset:
English: Ciprofloxacino Sandoz Ciprofloxacin 500mg Tablet
Croatian: Ciprofloxacino Sandoz Ciprofloksacin 500 mg tableta Filmom obložena tableta
English: Moxifloxacina Ciclum Moxifloxacin 400mg Tablet
Croatian: Moxifloxacina Ciclum Moksifloksacin 400 mg tableta Filmom obložena tableta
English: Ciprofloxacine Sandoz Ciprofloxacin 750mg Tablet
Croatian: Ciprofloxacine Sandoz Ciprofloksacin 750 mg tableta Filmom obložena tableta
English: Ciprofloxacin Mylan Ciprofloxacin 750mg Tablet
Croatian: Ciprofloxacin Mylan Ciprofloksacin 750 mg tableta Filmom obložena tableta
English: Ciprofloxacin Sandoz Ciprofloxacin 750mg Tablet
Croatian: Ciprofloxacin Sandoz Ciprofloksacin 750 mg tableta Filmom obložena tableta
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 256.23mg Tablet
Croatian: Levofloxacine Pch Levofloksacin hemihidrat 256,23 mg tableta
English: Moxifloxacin Mylan Moxifloxacin 400mg Tablet
Croatian: Moxifloxacino Mylan Moksifloksacin 400 mg tableta Filmom obložena tableta
English: Levofloxacina Farmoz Levofloxacin 250mg Tablet
Croatian: Levofloxacina Farmoz Levofloksacin 250 mg tableta Filmom obložena tableta
English: Levofloxacin Mylan Levofloxacin 250mg Tablet
Croatian: Levofloxacin Mylan Levofloksacin 250 mg tableta Filmom obložena tableta
English: Levofloxacina Sandoz Levofloxacin 500mg Tablet
Croatian: Levofloxacina Sandoz Levofloksacin 500 mg tableta Filmom obložena tableta
English: Levofloxacino Stada Levofloxacin 500mg Tablet
Croatian: Levofloxacino Stada Levofloksacin 500 mg tableta Filmom obložena tableta
English: Oral Suspension
Croatian: Oralna suspenzija Peroralna primjena
English: Moxifloxacin Sandoz Moxifloxacin 400mg Tablet
Croatian: Moxifloxacin Sandoz Moksifloksacin 400 mg tableta Filmom obložena tableta
English: Levofloxacin Accord Levofloxacin 500mg/100 Ml
Croatian: Accord Healthcare Limited Levofloxacin Accord Levofloksacin 500 mg/100 ml
English: Ciprofloxacina Actavis Ciprofloxacin 250mg Tablet
Croatian: Ciprofloxacina Actavis Ciprofloksacin 250 mg tableta Filmom obložena tableta
English: Ciprofloxacina Mylan Ciprofloxacin 250mg Tablet
Croatian: Ciprofloxacina Mylan Ciprofloksacin 250 mg tableta Filmom obložena tableta
English: All animals should have had water from the same source
Croatian: Sve životinje trebale su dobiti vodu iz istog izvora
English: Fatalities are extremely rare.
Croatian: Pogubni slučajevi iznimno su rijetki.
English: The authors could not provide a sound explanation for this.
Croatian: Autori nisu mogli pružiti razumno objašnjenje za to.
English: Therefore this statement is not maintained.
Croatian: Stoga se ta izjava ne zadržava.
English: These effects might be delayed and subtle.
Croatian: Ti učinci mogu biti odgođeni i suptilni.
English: Other safety aspects
Croatian: Drugi sigurnosni aspekti
English: Risks
Croatian: Rizici
English: Higher relaxivity of Multihance
Croatian: Veći relaksivitet Multihancea
English: In accordance with Article 107k of Directive 2001/83/EC, the CHMP considered the PRAC recommendation adopted on 6 July 2017.
Croatian: U skladu s člankom 107. točkom (k) Direktive 2001/83/EZ, CHMP razmotrio je PRAC-ovu preporuku donesenu 6. srpnja 2017.
English: In addition, the repeated use of these products is most unlikely.
Croatian: Nadalje, ponovljena uporaba tih lijekova nije vjerojatna.
English: In view of the above, the PRAC concluded that:
Croatian: Uzimajući u obzir prethodno navedeno, PRAC zaključuje sljedeće:
English: Neither would the introduction of educational material address this issue.
Croatian: Taj problem ne bi riješilo ni uvođenje edukativnih materijala.
English: Therefore the condition should not mention “including the brains in human.”
Croatian: Stoga uvjet ne treba sadržavati izraz „uključujući ljudski mozak”.
English: Particularly, it was stated that the influence on patient management was not directly demonstrated by the study results.
Croatian: Konkretno, utvrđeno je da utjecaj na upravljanje bolesnikom nije izravno pokazan u rezultatima ispitivanja.
English: The experts at the ad-hoc expert meeting shared these same views.
Croatian: Stručnjaci na ad hoc sastanku donijeli su isto mišljenje.
English: In case such studies were however to be carried out, patients would bear the risks as long as ongoing research is not completed.
Croatian: U slučaju da se takva ispitivanja ipak provedu, bolesnici bi snosili rizike sve dok se ispitivanje ne dovrši.
English: The long-term clinical consequences of such gadolinium retention are currently unknown.
Croatian: Dugoročne kliničke posljedice takvog zadržavanja gadolinija trenutačno nisu poznate.
English: In general, appropriate medications, equipment and staff experienced in the management of hypersensitivity reactions can be expected in any radiological practice.
Croatian: Općenito gledajući, odgovarajući lijekovi, oprema i osoblje s iskustvom u upravljanju reakcijama preosjetljivosti može se očekivati u bilo kojoj radiološkoj praksi.
English: Detailed conclusions from the meeting can be found in the enclosure 11 to the PRAC assessment report.
Croatian: Detaljni zaključci sa sastanka dostupni su u prilogu 11. u PRAC-ovom izvješću o procjeni.
English: This clearly indicates that potential dechelation in the body is a recognised phenomenon.
Croatian: To jasno pokazuje da je moguća dekelacija u tijelu poznati fenomen.
English: Although in patients with a history of drug allergy the reaction risk might be increased, the risk is still very low.
Croatian: Iako se u bolesnika s povijesti alergija na lijekove rizik od reakcije može povećati, rizik je i dalje vrlo malen.
English: The linear compounds therefore particularly persist in the brain.
Croatian: Linearni spojevi stoga se posebno zadržavaju u mozgu.
English: However, it demonstrates the complexity and difficulties associated with the objective of analysing potential neurological effects.
Croatian: Međutim, pokazuje složenost i poteškoće povezane s analizom mogućih neuroloških učinaka.
English: Premedication with antihistamines and corticosteroids could also be applied.
Croatian: Može se primijeniti premedikacija antihistaminicima i kortikosteroidima.
English: The implemented risk minimisation measures appear to be effective based on annual reviews of spontaneous case reports.
Croatian: Čini se da su provedene mjere za smanjenje rizika djelotvorne na temelju godišnjih ocjena izvješća o pojedinačnom slučaju.
English: With these uncertainties, conclusions on different or similar behaviour of the different contrast agents studied by McDonald et al. are not possible.
Croatian: Uz te nesigurnosti, zaključke o različitom ili sličnom ponašanju različitih kontrastnih sredstava koje su ispitivali McDonald i dr. nije moguće donijeti.
English: The vast majority of these reactions are non-serious, with a very low percentage of patients experiencing severe hypersensitivity reactions.
Croatian: Većina tih reakcija nije ozbiljna, pri čemu vrlo mali postotak bolesnika doživi teške reakcije preosjetljivosti.
English: Macrocyclic GdCAs
Croatian: Makrociklički GdCA-ovi
English: Interventional clinical studies comparing the different products could be considered unethical.
Croatian: Intervencijska klinička ispitivanja koja uspoređuju razne lijekove mogla bi se smatrati neetičnima.
English: The PRAC considered that a 2nd ad-hoc expert meeting was warranted to address some of the aspects that formed part of the detailed grounds submitted by Bracco and GE Healthcare.
Croatian: 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.
English: Such long-term safety studies are unlikely to be feasible within reasonable period of time.
Croatian: Nije vjerojatno da će takva dugoročna ispitivanja biti provediva u razumnom vremenskom roku.
English: These areas are involved in the regulation of voluntary and involuntary movement; adverse events could potentially include events such as ataxia, tremors and other movement disorders.
Croatian: Ta područja sudjeluju u reguliranju dobrovoljnih i nedobrovoljnih pokreta; štetni učinci mogu uključivati ataksiju, drhtavicu i druge poremećaje kretanja.
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).
Croatian: Vjeruje se da je to razdvajanje povezano s razlikama u stabilnosti kompleksa raznih vrsta GdCA sredstava (Spencer i dr. 1997.).
English: Despite worldwide use serious adverse reactions are rare; urticaria is the most common manifestation.
Croatian: Unatoč uporabi diljem svijeta, štetne reakcije su rijetke, urtikarija je najčešća nuspojava.
English: National assessment
Croatian: Nacionalna procjena
English: Overall, the experts expressed divergent views concerning the risk minimisation measures.
Croatian: Stručnjaci su uglavnom iznijeli različita mišljenja u vezi s mjerama za smanjenje rizika.
English: They are used for contrast enhancement in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA).
Croatian: Koriste se za povećanje kontrasta pri snimanju magnetskom rezonancijom (MRI) i pri magnetskoj angiografiji (MRA).
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.
Croatian: 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.
English: Additionally, it is not possible to define a period of time during which no potential adverse effect would have time to manifest.
Croatian: Nadalje, nije moguće odrediti vremensko razdoblje tijekom kojeg bi se mogući štetni učinci mogli pokazati.
English: • The shape and size of the T1 signal is markedly different from the signal shape reported in two other recent publications, (Jost et al., 2016, and Robert et al., 2015) and it is not fully clear whether the region of enhanced signal indeed corresponds to the DN, or other regions in the brain.
Croatian: • 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.
English: 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.
Croatian: 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.
English: Furthermore, the frequency and timing of applications may not be completely recorded in radiologist's patient file/and or accessible to future contacted radiologist or general practitioner, because the patient has changed the radiologist/general practitioner several times due to change of residence or due to other reasons.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: PRAC conclusions on grounds for re-examination
Croatian: Zaključci PRAC-a o razlozima za ponovnu ocjenu
English: 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.
Croatian: 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.
English: A number of studies have shown a correlation between the number of exposures to linear GdCAs and the signal intensity changes.
Croatian: Brojna ispitivanja pokazala su vezu između broja izlaganja linearnim GdCA-ovima i promjene u intenzitetu signala.
English: • the dynamic phase, for which all the authorised GdCAs can provide enhancement of liver imaging,
Croatian: • dinamična faza u kojoj svi odobreni GdCA-ovi mogu poboljšati snimanje jetre,
English: Enhancement after gadobenate dimeglumine (Multihance) or gadopentetate dimeglumine (Magnevist) appeared more progressively compared with gadodiamide.
Croatian: Poboljšanje nakon primjene gadobenata dimeglumina (Multihance) ili gadopentetata dimeglumina (Magnevist) činilo se progresivnije u usporedbi s gadodiamidom.
English: These observations leave the possibility that the method used for the Gd determination is unreliable under certain circumstances.
Croatian: Ta zapažanja ostavljaju mogućnost da je metoda koja je korištena za utvrđivanje gadolinija nepouzdana u određenim okolnostima.
English: Benefit/risk balance
Croatian: Omjer koristi/rizika
English: The regions of the brain with the greatest potential for brain accumulation are the dentate nucleus and globus pallidus.
Croatian: Područja mozga koja imaju najveći potencijal za taloženje na mozgu su dentatni nukleus i globus pallidus.
English: Toxicity of non-chelated gadolinium
Croatian: Toksičnost nekeliranog gadolinija
English: The absolute rate of hypersensitivity reactions with GdCAs is low and reported as approximately 0.01% to 0.001% across the studies investigating rates of hypersensitivity reactions.
Croatian: Apsolutna stopa reakcija preosjetljivosti nakon primjene GdCA-ova niska je i iznosi približno 0,01 % do 0,001 % u svim ispitivanjima u kojima se ispitivala stopa reakcija preosjetljivosti.
English: • The practical implementation of these measures is moreover not deemed feasible in a clinical setting.
Croatian: • Praktična primjena tih mjera ne smatra se provedivom u kliničkom okruženju.
English: The levels remained low at 20 weeks and no further reduction was observed at week 50, suggesting that there may be retention of gadolinium in the brain in the long term with no evidence of clearance up to 1 year.
Croatian: Razine su ostale na niskoj razini pri razdoblju od 20 tjedana te do 50 tjedna nisu primijećena dodatna smanjenja, što znači da zadržavanje gadolinija u mozgu može biti dugoročno, bez dokaza o povlačenju do 1 godine.
English: For the linear agents evaluated in non-clinical studies the T1 signal intensity in the DCN has been shown to persist for at least 1 year without any reduction in intensity.
Croatian: Za linearna sredstva koja su ocjenjivana u nekliničkim ispitivanjima, pokazano je da intenzitet T1 signala za DCN traje najmanje 1 godinu bez smanjenja intenziteta.
English: • Only a small signal was detected in a brain region which McDonald et al. assumed to be the dentate nucleus (DN), but this assignment is not convincing when regarding the figures shown.
Croatian: • Otkriven je samo maleni signal u području mozga za koje su McDonald i dr. pretpostavili da je dentatni nukleus (DN), ali taj dokaz nije uvjerljiv nakon pregleda prikazanih brojki.
English: Furthermore, the CHMP noted that the changes to the package leaflet for Multihance (gadobenic acid) had not been fully implemented in the PRAC assessment report; the correct wording is provided in the Annex to this opinion.
Croatian: Nadalje, CHMP je utvrdio da se izmjene u uputi o lijeku za Multihance (gadobenska kiselina) nisu u potpunosti provele u izvješću o procjeni PRAC-a; ispravan tekst naveden je u Prilogu ovom mišljenju.
English: Moreover, there is concern that gadolinium deposition could worsen existing inflammatory diseases, as accumulation in inflammatory lesions has been observed.
Croatian: Štoviše, postoji zabrinutost da bi taloženje gadolinija moglo pogoršati postojeće upalne bolesti jer je primijećeno taloženje u upaljenim lezijama.
English: • CHMP considered options for risk minimisation measures.
Croatian: • CHMP je razmotrio opcije mjera za smanjenje rizika.
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.
Croatian: Međutim, PRAC smatra da je potrebno dodatno istražiti podatke o taloženju u mozgu i kliničke posljedice tog taloženja u odgovarajućem okviru, što zahtijeva pregled na razini EU-a.
English: For gadobenic acid, the available studies do not establish differences in relaxivity, image quality and technical performance.
Croatian: Dostupna ispitivanja gadobenske kiseline ne pokazuju razlike u relaksivitetu, kvaliteti slike i tehničkoj izvedbi.
English: In addition, macrocyclic agents are associated with a low risk of NSF.
Croatian: Nadalje, makrociklička sredstva povezana su s niskim rizikom od NSF-a.
English: Smith et al. 2017 described that stored Gd still decreases after one week so that obviously a transiently stored pool exists which is different from the material that persists long-term.
Croatian: Smith i dr. (2017.) opisali su da se pohranjeni gadolinij smanjuje nakon jednog tjedna tako da očito postoji prijelazno pohranjeni materijal koji se razlikuje od materijala koji se dugoročno zadržava.
English: For all Gd contrast agents, the experts stated that the general “As Low As Reasonably Achievable” (ALARA) principles should be used and that the exposure to all GdCAs should be minimised, either by reducing the dose or using alternative diagnostic methods, if possible.
Croatian: Za sva kontrastna sredstva koja sadrže gadolinij stručnjaci su izjavili da treba koristiti opća načela „što niža doza” (“As Low As Reasonably Achievable”, ALARA) i da treba smanjiti izloženost svim GdCAovima , smanjenjem doze ili uporabom alternativnih dijagnostičkih metoda (ako je to moguće).
English: Skin prick testing could facilitate the identification of an alternative GdCA.
Croatian: Ispitivanje krvi iz prsta može olakšati otkrivanje alternativnoga GdCA sredstva.
English: Notwithstanding this, and given the detailed grounds provided by the MAHs, the PRAC carried out a new assessment of the available data in the context of the reexamination.
Croatian: Neovisno o tome i uzimajući u obzir detaljne razloge koje su naveli nositelji odobrenja za stavljanje u promet, PRAC je proveo novu ocjenu dostupnih podataka u kontekstu ponovne ocjene.
English: The PRAC confirmed it had considered the totality of the data submitted by the MAHs in the context of the initial referral procedure.
Croatian: PRAC je potvrdio da je razmotrio sve podatke koje su podnijeli nositelji odobrenja u kontekstu početnog postupka upućivanja.
English: These effects can be mimicked in vitro and will further diminish the stability of the GdCA complex in vivo.
Croatian: Ti se učinci mogu oponašati in vitro te će dodatno smanjiti stabilnost GdCA kompleksa in vivo.
English: Overall summary of the scientific evaluation by the PRAC Background
Croatian: Cjelokupan sažetak znanstvene ocjene PRAC-a Kontekst
English: The CHMP, having considered the PRAC recommendation, is of the view that the following clarifications to the PRAC grounds and recommendation are necessary:
Croatian: CHMP nakon razmatranja preporuke PRAC-a smatra da je potrebno dodatno objašnjenje sljedećih PRAC-ovih razloga i preporuka:
English: Data from the clinical post-mortem studies are heterogeneous and it is therefore difficult to compare the levels.
Croatian: Podaci iz kliničkih post mortem ispitivanja heterogeni su te je stoga teško usporediti razine.
English: However linear agents are retained and persist for up to one year or longer.
Croatian: Međutim, linearna sredstva zadržavaju se do jedne godine ili duže.
English: All GdCAs have some degree of renal elimination, which varies from 50% for gadoxetic acid to 100% for most other members of the class.
Croatian: Svi GdCA-ovi u određenoj se mjeri izlučuju kroz bubrege, od 50 % za gadoksetičnu kiselinu do 100 % za ostala sredstva iz tog razreda.
English: The MAHs were also requested to update the safety specifications in the Risk Management Plans for these products to reflect these findings.
Croatian: . Od nositelja odobrenja zatraženo je i da ažuriraju sigurnosne specifikacije u planovima za upravljanje rizikom za te lijekove kako bi se prikazala navedena otkrića.
English: 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.
Croatian: Međutim, ta ispitivanja imaju značajna ograničenja (npr. ispitivanja ne mogu isključiti izlaganje linearnim GdCA-ovima prije početka ispitivanja) te se stoga ne može utvrditi uzročna veza s makrocikličkim sredstvima.
English: Many of these are common but typically non-serious reactions, such as rash, urticaria, and flushing.
Croatian: Mnogi od njih uobičajeni su, ali obično to nisu ozbiljne reakcije, na primjer osip, urtikarija i crvenilo kože.
English: It should be noted that McDonald et al. (2017) reported very little Gd deposition.
Croatian: Valja napomenuti da su McDonald i dr. (2017.) prijavili vrlo malo taloženje gadolinija.
English: The macrocyclic agent gadobutrol did not show hyperintensity after this time period.
Croatian: Makrocikličko sredstvo gadobutrol nije pokazalo prekomjernu osjetljivost nakon tog vremenskog razdoblja.
English: In January 2016, in the framework of a PSUSA procedure, the PRAC reviewed all available literature and data related to the accumulation of gadolinium in the brain and recommended the removal of statements from the product information of all GdCAs that the products do not pass the intact blood brain barrier.
Croatian: U okviru postupka PSUSA, PRAC je u siječnju 2016. pregledao svu dostupnu literaturu i podatke povezane s taloženjem gadolinija u mozgu i preporučio uklanjanje izjava iz informacija o lijeku za sve GdCA-ove o tome da lijek ne prelazi netaknutu krvno-moždanu barijeru
English: Cardiac MR including perfusion and delayed enhancement imaging provides relevant information in terms of viable tissue in various cardiovascular disorders needed for work up and management of these diseases.
Croatian: MR srca, uključujući snimanje perfuzije i snimanje u odgođenoj fazi pruža važne informacije u pogledu održivog tkiva u raznim kardiovaskularnim poremećajima potrebnog za rad i upravljanje tim bolestima.
English: Furthermore, the standard deviation of Gd content in the brain was extraordinary high for Gadovist.
Croatian: Štoviše, standardno odstupanje od sadržaja gadolinija u mozgu bilo je iznimno visoko za Gadovist.