natgillin/translations-raw huggingface dataset:
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
The increased potential to release gadolinium in the brain would be expected with the linear agents, which have a lower kinetic and thermodynamic stability and are thus more prone to release gadolinium in the tissue environment.
Večja možnost sproščanja gadolinija v možgane bi se pričakovala pri linearnih sredstvih, ki imajo manjšo kinetično in termodinamično stabilnost ter so zato bolj nagnjena k sproščanju gadolinija v okolje tkiv.
A restriction by number of doses may not be possible in clinical practice, because previous exposures to GdCAs may not have been recorded sufficiently with regard to the type of GdCA used.
Omejitev števila odmerkov v klinični praksi morda ne bi bila mogoča, ker predhodne izpostavljenosti sredstvom GdCA morda ne bi bile ustrezno evidentirane glede na vrsto uporabljenega sredstva GdCA.
All GdCAs have some degree of renal elimination, which varies from 50% for gadoxetic acid to 100% for most other members of the class.
Vsa sredstva GdCA se v določeni meri izločajo skozi ledvice, gadoksetna kislina v 50 %, večina drugih članov tega razreda pa v 100 %.
Moreover, there is concern that gadolinium deposition could worsen existing inflammatory diseases, as accumulation in inflammatory lesions has been observed.
Poleg tega obstaja pomislek, da bi odlaganje gadolinija lahko poslabšalo obstoječe vnetne bolezni, saj je bilo kopičenje ugotovljeno v vnetnih lezijah.
Gadolinium containing contrast agents (GdCAs) are complexes of paramagnetic gadolinium (III) with different types of organic chelators.
Kontrastna sredstva, ki vsebujejo gadolinij (GdCA), so kompleksi paramagnetnega gadolinija (III) z različnimi vrstami organskih kelatorjev.
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).
Vsaka prihodnja klinična študija za proučitev dolgoročne varnosti sredstev GdCA pri bolnikih bi morala biti zasnovana tako, da bi vključevala veliko bolnikov, da bi bilo mogoče ugotoviti majhne neželene učinke na kognitivne (kognitivne motnje) ali fizične sposobnosti (finomotorične sposobnosti).
In general, appropriate medications, equipment and staff experienced in the management of hypersensitivity reactions can be expected in any radiological practice.
Na splošno je mogoče pričakovati, da imajo v vsaki radiološki ambulanti ustrezna zdravila, opremo in osebje, ki ima izkušnje z obvladovanjem preobčutljivostnih reakcij.
However linear agents are retained and persist for up to one year or longer.
Vendar pa se linearna sredstva zadržijo in ohranijo do enega leta ali dlje.
Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Potem ko je odbor CHMP pregledal priporočilo odbora PRAC, se je strinjal s končnimi zaključki in razlogi za priporočilo.
There is also a concern that gadolinium deposits in some tissues, particularly bone, could be released at a later stage for example during loss of bone density in aging or pregnancy/breastfeeding, exposing patients to further systemic distribution of gadolinium.
Obstaja tudi pomislek, da bi se lahko depoziti gadolinija v nekaterih tkivih, zlasti kostnih, sprostili pozneje, npr. med izgubo kostne gostote zaradi staranja ali med nosečnostjo/dojenjem, zaradi česar bi bili bolniki izpostavljeni nadaljnjemu sistemskemu razdeljevanju gadolinija.
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.
Odbor PRAC je januarja 2016 v okviru postopka za redno posodobljeno poročilo o varnosti zdravila (PSUSA) pregledal vso razpoložljivo literaturo in podatke v zvezi s kopičenjem gadolinija v možganih ter priporočil, da se za vsa sredstva GdCA iz informacij o izdelku odstranijo navedbe, da izdelki ne prehajajo skozi nepoškodovano krvno-možgansko pregrado.
It was also mentioned that there is currently little, if any, concern amongst experts specifically about the use of macrocyclic agents in clinical practice, and the current safety concern laying over all GdCAs arises from the clinical use of linear GdCAs.
Povedali so tudi, da je med strokovnjaki malo pomislekov, če sploh kaj, posebej glede uporabe makrocikličnih sredstev v klinični praksi, zdajšnji pomisleki v zvezi z varnostjo vseh sredstev GdCA pa izhajajo iz klinične uporabe linearnih sredstev GdCA.
Thus, rather weak binding of linear chelators to Gd becomes obvious in various experiments (including Port et al 2009, Sieber et al 2008), and this makes it unlikely that the complex is fully stable in vivo.
Precej šibka vezava linearnih kelatorjev na gadolinij postane očitna pri različnih poskusih (vključno s Port idr., 2009, Sieber idr., 2008), zato ni verjetno, da bi bil kompleks in vivo povsem stabilen.
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.
Kljub temu in glede na podrobno opisane razloge imetnikov dovoljenja za promet je v okviru ponovne proučitve znova ocenil razpoložljive podatke.
PRAC considered the detailed grounds as submitted by the MAHs within this re-examination procedure and the scientific data underlying these grounds.
Odbor PRAC je proučil podrobno opisane razloge, ki sta jih predložila imetnika dovoljenja za promet z zdravilom v okviru tega postopka ponovne proučitve, in znanstvene podatke, na katerih temeljijo ti razlogi.
Also PRAC was not able to define a safe threshold level for exposure to gadolinium and retention of gadolinium in the brain, or to define a period of time during which a potential adverse effect would have time to manifest.
Odbor PRAC prav tako ni mogel opredeliti varne mejne vrednosti za izpostavljenost gadoliniju in zadrževanje gadolinija v možganih ter časovnega obdobja, v katerem bi se morebitni neželeni učinek lahko pokazal.