FrancophonIA/ELRC3.0 huggingface dataset:
English: Moxifloxacino Actavis Moxifloxacin Hydrochloride 400mg Tablet
Lithuanian: Moxifloxacino Actavis Moxifloxacin Hydrochloride 400 mg tabletė
English: Ciprofloxacina Pensa Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Lithuanian: Ciprofloxacina Pensa Ciprofloxacin Hydrochloride Monohydrate 500 mg tabletė
English: Ciprofloxacin Hydrochloride 873mg Tablet
Lithuanian: Ciprofloxacin Hydrochloride 873 mg tabletė
English: Norfloxacin 400mg Tablet
Lithuanian: Norfloxacin 400 mg tabletė Dengta tabletė
English: Ciprofloxacin Hydrochloride 583mg Tablet
Lithuanian: Ciprofloxacin Hydrochloride 583 mg tabletė
English: Norfloxacin 400mg Capsule Capsule, Hard
Lithuanian: Norfloxacin 400 mg kapsulė Kietoji kapsulė
English: Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 750mg Tablet
Lithuanian: Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 750 mg tabletė
English: Levofloxacina Germed Levofloxacin Hemihydrate 512.46mg Tablet
Lithuanian: Levofloxacina Germed Levofloxacin Hemihydrate 512,46 mg tabletė
English: Ciprofloxacin Hydrochloride 500mg Tablet
Lithuanian: Ciprofloxacin Hydrochloride 500 mg tabletė
English: Levofloxacin 1a Pharma Levofloxacin 250mg Tablet
Lithuanian: Levofloxacin 1a Pharma Levofloxacin 250 mg tabletė Plėvele dengta tabletė Vartoti per burną
English: Ciprofloxacina Zentiva Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Lithuanian: Ciprofloxacina Zentiva Ciprofloxacin Hydrochloride Monohydrate 873 mg tabletė
English: Moxifloxacin Sandoz Moxifloxacin 400mg Tablet
Lithuanian: Moxifloxacin Sandoz Moxifloxacin Hydrochloride 400 mg tabletė
English: Ciprofloxacine Apotex Ciprofloxacin 750mg Tablet
Lithuanian: Ciprofloxacine Apotex Ciprofloxacin 750 mg tabletė Tabletė
English: Moxifloxacin Orion Moxifloxacin 400mg Bottle Solution For Infusion Intravenous Use
Lithuanian: Moxifloxacin Orion Moxifloxacin 400 mg flakonas Infuzinis tirpalas
English: Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Lithuanian: Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 582 mg tabletė
English: Ciprofloxacina Germed Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Lithuanian: Ciprofloxacina Germed Ciprofloxacin Hydrochloride Monohydrate 873 mg tabletė
English: Ofloxacine Ratiopharm Ofloxacin 200mg Tablet
Lithuanian: Ofloxacine Ratiopharm Ofloxacin 200 mg tabletė
English: Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 250mg Tablet
Lithuanian: Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 250 mg tabletė
English: Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Lithuanian: Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 500 mg tabletė
English: Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Lithuanian: Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 873 mg tabletė
English: Levofloxacina Arena Levofloxacin Hemihydrate 512.46mg Tablet
Lithuanian: Levofloxacina Arena Levofloxacin Hemihydrate 512,46 mg tabletė
English: Ciprofloxacina Hikma Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Lithuanian: Ciprofloxacina Hikma Ciprofloxacin Hydrochloride Monohydrate 873 mg tabletė
English: Norfloxacino Normon Norfloxacin 400mg Tablet
Lithuanian: Norfloxacino Normon Norfloxacin 400 mg tabletė Dengta tabletė
English: Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 250mg Tablet
Lithuanian: Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 250 mg tabletė
English: Bluefish Pharmaceuticals Ab Ciprofloxacin Bluefish Ciprofloxacin 250mg Tablet
Lithuanian: Bluefish Pharmaceuticals Ab Ciprofloxacin Bluefish Ciprofloxacin 250 mg tabletė Plėvele dengta tabletė Vartoti per burną
English: Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 250mg Tablet
Lithuanian: Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 250 mg tabletė
English: Levofloxacin Hetero Levofloxacin Hemihydrate 512.47mg Tablet
Lithuanian: Levofloxacin Hetero Levofloxacin Hemihydrate 512,47 mg tabletė
English: Ciprofloxacine Apotex Ciprofloxacin 250mg Tablet
Lithuanian: Ciprofloxacine Apotex Ciprofloxacin 250 mg tabletė Tabletė
English: Ofloxacin Ratiopharm Ofloxacin 200mg Tablet
Lithuanian: Ofloxacin Ratiopharm Ofloxacin 200 mg tabletė
English: Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 750mg Tablet
Lithuanian: Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 750 mg tabletė
English: Moxifloxacin Actavis Moxifloxacin Hydrochloride 400mg Tablet
Lithuanian: Moxifloxacin Actavis Moxifloxacin Hydrochloride 400 mg tabletė
English: Ciprofloxacin Hydrochloride 291mg Tablet
Lithuanian: Ciprofloxacin Hydrochloride 291 mg tabletė
English: Ciprofloxacin Hydrochloride 582mg Tablet
Lithuanian: Ciprofloxacin Hydrochloride 582 mg tabletė
English: Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Lithuanian: Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 500 mg tabletė
English: Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 583mg Tablet
Lithuanian: Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 583 mg tabletė
English: Levofloxacina Accord Levofloxacin Hemihydrate 256.23mg Tablet
Lithuanian: Accord Healthcare Limited Levofloxacina Accord Levofloxacin Hemihydrate 256,23 mg tabletė
English: Levofloxacin 512,46mg Tablet Film-Coated Tablet
Lithuanian: Levofloxacin 512,46 mg tabletė
English: Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 750mg Tablet
Lithuanian: Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 750 mg tabletė
English: Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 500mg Tablet
Lithuanian: Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 500 mg tabletė Plėvele dengta tabletė Vartoti per burną
English: Levofloxacina Germed Levofloxacin Hemihydrate 256.23mg Tablet
Lithuanian: Levofloxacina Germed Levofloxacin Hemihydrate 256,23 mg tabletė
English: Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 250mg Tablet
Lithuanian: Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 250 mg tabletė Plėvele dengta tabletė Vartoti per burną
English: Bluefish Pharmaceuticals Ab Ciprofloxacin Bluefish Ciprofloxacin 500mg Tablet
Lithuanian: Bluefish Pharmaceuticals Ab Ciprofloxacin Bluefish Ciprofloxacin 500 mg tabletė Plėvele dengta tabletė Vartoti per burną
English: Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 500mg Tablet
Lithuanian: Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 500 mg tabletė Plėvele dengta tabletė Vartoti per burną
English: Ciprofloxacin Hydrochloride 291.5mg Tablet
Lithuanian: Ciprofloxacin Hydrochloride 291,5 mg tabletė
English: Ciprofloxacin Hydrochloride 291.1mg Tablet
Lithuanian: Ciprofloxacin Hydrochloride 291,1 mg tabletė
English: Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Lithuanian: Ciprofloxacino Cinfa Ciprofloxacin Hydrochloride Monohydrate 500 mg tabletė
English: Ciprofloxacine Hikma Ciprofloxacin 200mg Vial
Lithuanian: Ciprofloxacine Hikma Ciprofloxacin 200 mg flakonas
English: Moxifloxacin 436.32mg Tablet Film-Coated Tablet
Lithuanian: Moxifloxacin 436,32 mg tabletė
English: Ciprofloxacina Jaba
Lithuanian: Ciprofloxacina Ranbaxy
English: Levofloxacina Generis Levofloxacin Hemihydrate 256.23mg Tablet
Lithuanian: Levofloxacina Generis Levofloxacin Hemihydrate 256,23 mg tabletė
English: Levofloxacina Generis Levofloxacin Hemihydrate 512.46mg Tablet
Lithuanian: Levofloxacina Generis Levofloxacin Hemihydrate 512,46 mg tabletė
English: Pipemidic Acid 400mg Capsule Capsule, Hard
Lithuanian: Pipemidic Acid 400 mg kapsulė Kietoji kapsulė
English: Ranbaxy Pharmacie Generiques Ofloxacine Ranbaxy Ofloxacin 200mg Tablet
Lithuanian: Ofloxacine Ranbaxy Ofloxacin 200 mg tabletė
English: G.E.S.
Lithuanian: Z O.O.
English: Levofloxacin Hetero Levofloxacin Hemihydrate 256.23mg Tablet
Lithuanian: Levofloxacina Hetero Levofloxacin Hemihydrate 256,23 mg tabletė
English: Levofloxacin Accord Levofloxacin Hemihydrate 512.46mg Tablet
Lithuanian: Levofloxacino Accord Levofloxacin Hemihydrate 512,46 mg tabletė
English: Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 250mg Tablet
Lithuanian: Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 250 mg tabletė
English: Ciprofloxacin 500mg Sachet Oral Suspension In Sachet
Lithuanian: Ciprofloxacin 500 mg maišelis Geriamoji suspensija paketėlyje
English: Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 500mg Tablet
Lithuanian: Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 500 mg tabletė
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 512.46mg Tablet
Lithuanian: Levofloxacine Pch Levofloxacin Hemihydrate 512,46 mg tabletė
English: Moxifloxacin Hydrochloride 436.37mg Container
Lithuanian: Moxifloxacin Hydrochloride 436,37 mg talpyklė
English: Pefloxacin Laropharm Pefloxacin 400mg Tablet
Lithuanian: Pefloxacin Laropharm Pefloxacin 400 mg tabletė Plėvele dengta tabletė Vartoti per burną
English: Levofloxacin Arcana Levofloxacin 250mg/50 Ml
Lithuanian: Arcana Arzneimittel Gmbh Levofloxacin Arcana Levofloxacin 250 mg/50 Ml
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 582mg Tablet
Lithuanian: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacin Hydrochloride 582 mg tabletė
English: Levofloxacina Accord Levofloxacin Hemihydrate 512.46mg Tablet
Lithuanian: Accord Healthcare Limited Levofloxacina Accord Levofloxacin Hemihydrate 512,46 mg tabletė
English: Levofloxacino Accord Levofloxacin Hemihydrate 512.46mg Tablet
Lithuanian: Accord Healthcare Limited Levofloxacin Accord Levofloxacin Hemihydrate 512,46 mg tabletė
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 256.23mg Tablet
Lithuanian: Levofloxacina Arena Levofloxacin Hemihydrate 256,23 mg tabletė
English: Ciprofloxacin Heumann Ciprofloxacin 100mg Tablet
Lithuanian: Ciprofloxacin Hikma Ciprofloxacin 200 mg flakonas
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 873mg Tablet
Lithuanian: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacin Hydrochloride 873 mg tabletė
English: Norfloxacine Cristers Norfloxacin 400mg Tablet
Lithuanian: Norfloxacine Cristers Norfloxacin 400 mg tabletė Plėvele dengtos tabletės Vartoti per burną
English: Ciprofloxacine Fair-Med Ciprofloxacin Hydrochloride 291mg Tablet
Lithuanian: Fairmed Healthcare Gmbh Ciprofloxacin Fair-Med Ciprofloxacin Hydrochloride 291 mg tabletė
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Lithuanian: Burnoje disperguojamoji tabletė
English: All animals should have had water from the same source
Lithuanian: Visi gyvūnai turėjo gauti vandenį iš to paties šaltinio;
English: Fatalities are extremely rare.
Lithuanian: Mirties atvejai itin reti.
English: Other safety aspects
Lithuanian: Kiti saugumo aspektai
English: Therefore this statement is not maintained.
Lithuanian: Todėl šis teiginys išbraukiamas.
English: Overall, the experts expressed divergent views concerning the risk minimisation measures.
Lithuanian: Apskritai ekspertai išreiškė skirtingas nuomones dėl rizikos mažinimo priemonių.
English: In case such studies were however to be carried out, patients would bear the risks as long as ongoing research is not completed.
Lithuanian: Jeigu tokie tyrimai vis dėlto būtų atliekami, pacientams tokia rizika būtų keliama tol, kol moksliniai tyrimai nebūtų užbaigti.
English: In addition, the repeated use of these products is most unlikely.
Lithuanian: Be to, pakartotinis šių preparatų naudojimas yra visiškai mažai tikėtinas.
English: Premedication with antihistamines and corticosteroids could also be applied.
Lithuanian: Taip pat gali būti taikoma premedikacija antihistaminais ir kortikosteroidais.
English: The authors could not provide a sound explanation for this.
Lithuanian: Autoriai negalėjo įtikinamai paaiškinti tokio reiškinio priežasčių.
English: This clearly indicates that potential dechelation in the body is a recognised phenomenon.
Lithuanian: Tai aiškiai parodo, kad galima dechelacija žmogaus organizme yra pripažįstamas reiškinys.
English: In view of the above, the PRAC concluded that:
Lithuanian: Atsižvelgdamas į tai, kas išdėstyta pirmiau, PRAC priėjo prie išvados, kad:
English: Nephrogenic systemic fibrosis (NSF)
Lithuanian: Nefrogeninė sisteminė fibrozė (NSF)
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.
Lithuanian: Tai buvo aptarta su klinikiniais ekspertais ad hoc ekspertų grupės posėdyje, kurio metu patvirtinta galima sąsaja, bet tai dar neįrodyta.
English: National assessment
Lithuanian: Nacionalinis vertinimas
English: The experts at the ad-hoc expert meeting shared these same views.
Lithuanian: Ad hoc ekspertų posėdyje dalyvavę ekspertai pritarė šioms nuomonėms.
English: The long-term clinical consequences of such gadolinium retention are currently unknown.
Lithuanian: Ilgalaikės klinikinės tokio gadolinio užsilaikymo organizme pasekmės šiuo metu nežinomos.
English: The vast majority of these reactions are non-serious, with a very low percentage of patients experiencing severe hypersensitivity reactions.
Lithuanian: Didžioji dauguma šių reakcijų yra nesunkios ir tik labai nedidelė procentinė dalis pacientų patiria sunkias padidėjusias jautrumo reakcijas.
English: Such long-term safety studies are unlikely to be feasible within reasonable period of time.
Lithuanian: Galimybė atlikti tokius ilgalaikius saugumo tyrimus per tam tikrą pagrįstą laikotarpį mažai tikėtina.
English: Neither would the introduction of educational material address this issue.
Lithuanian: Šviečiamoji medžiaga taip pat neišspręstų šios problemos.
English: Additionally, it is not possible to define a period of time during which no potential adverse effect would have time to manifest.
Lithuanian: Be to, neįmanoma nustatyti laikotarpio, per kurį galimas nepageidaujamas poveikis turėtų pasireikšti.
English: Therefore the condition should not mention “including the brains in human.”
Lithuanian: Todėl šioje sąlygoje turėtų nelikti formuluotės „įskaitant žmonių galvos smegenis“.
English: Particularly, it was stated that the influence on patient management was not directly demonstrated by the study results.
Lithuanian: Visų pirma buvo nurodyta, kad tyrimų rezultatai tiesiogiai nepatvirtino įtakos pacientų gydymui.
English: Interventional clinical studies comparing the different products could be considered unethical.
Lithuanian: Intervenciniai klinikiniai tyrimai, kurių metu būtų lyginami skirtingi preparatai, gali būti laikomi neetiškais.
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).
Lithuanian: Manoma, kad toks atskilimas susijęs su įvairių rūšių KMG kompleksų stabilumo skirtumais (Spencer et al., 1997).
English: Detailed conclusions from the meeting can be found in the enclosure 11 to the PRAC assessment report.
Lithuanian: Išsamios šio posėdžio išvados pateikiamos PRAC vertinimo protokolo 11 priede.
English: It is not fully clear how reliable the method of Gd quantification in tissue was.
Lithuanian: Nėra visiškai aišku, kiek patikimas buvo šis gadolinio kiekio audiniuose nustatymo metodas;
English: The MAHs were also requested to update the safety specifications in the Risk Management Plans for these products to reflect these findings.
Lithuanian: Registruotojų taip pat buvo paprašyta atnaujinti saugumo specifikacijas šių preparatų rizikos valdymo planuose, kad į jas būtų įtraukta informacija apie šiuos nustatytus faktus.
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.
Lithuanian: Kalbant apie nuorodą į ankstesnį vertinimą, kuris buvo atliktas nacionaliniu lygmeniu (II tipo variacija, siekiant išplėsti Multihance indikaciją, UK/H/0234/001-002/II/038), reikėtų atkreipti dėmesį į tai, kad paraiškos dėl variacijos vertinimo procedūros taikymo sritis skiriasi nuo 31 straipsnyje numatytos kreipimosi procedūros, tad šios dvi procedūros vykdomos remiantis skirtingais duomenų rinkiniais, todėl jų rezultatai pagrįstai gali skirtis.
English: They are used for contrast enhancement in magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA).
Lithuanian: Jie naudojami siekiant padidinti kontrastą, atliekant magnetinio rezonanso vaizdinimo tyrimą (MRVT) ir magnetinio rezonanso angiografiją (MRA).
English: Higher relaxivity of Multihance
Lithuanian: Didesnis Multihance relaksuojamumas
English: The linear compounds therefore particularly persist in the brain.
Lithuanian: Todėl linijinės struktūros junginiai visų pirma išlieka galvos smegenyse.
English: • The practical implementation of these measures is moreover not deemed feasible in a clinical setting.
Lithuanian: • Be kita ko, manoma, kad šių priemonių praktinis taikymas klinikinėje praktikoje yra neįmanomas.
English: Although in patients with a history of drug allergy the reaction risk might be increased, the risk is still very low.
Lithuanian: Nors pacientams, kuriems praeityje pasireiškė alergija vaistams, gali kilti didesnė tokių reakcijų rizika, ji vis tiek yra labai nedidelė.
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.
Lithuanian: Vis dėlto PRAC nusprendė, kad žinias apie gadolinio kaupimąsi galvos smegenyse ir šio reiškinio klinikines pasekmes reikia išsamiau ištirti pagal atitinkamą sistemą, todėl būtina atlikti peržiūrą ES mastu.
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.
Lithuanian: • T1 režimu matomo signalo forma ir dydis ryškiai skiriasi nuo signalo formos, aprašytos kituose dviejuose neseniai paskelbtuose straipsniuose (Jost et al., 2016, ir Robert et al., 2015), ir nėra visiškai aišku, ar ši stipresnio signalo sritis iš tiesų susijusi su DB, ar su kitomis galvos smegenų sritimis;
English: These observations leave the possibility that the method used for the Gd determination is unreliable under certain circumstances.
Lithuanian: Šie pastebėjimai leidžia manyti, kad tam tikromis aplinkybėmis gadolinio kiekiui nustatyti naudojamas metodas gali būti nepatikimas.
English: 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.
Lithuanian: Taigi, pakankamai silpnas linijinės struktūros chelatorių jungimasis prie gadolinio tampa akivaizdus atliekant įvarius bandymus (įskaitant Port et al, 2009, Sieber et al, 2008), todėl mažai tikėtina, kad šis kompleksas yra visiškai stabilus in vivo.
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.
Lithuanian: Taigi, PRAC laikėsi nuomonės, kad dėl McDonald et al.tyrimo nėra pagrindo keisti ankstesnių komiteto išvadų ir atkreipė dėmesį į tai, kad šiai nuomonei taip pat pritarė ad hoc ekspertų grupė, kurios posėdis įvyko birželio 19 d.
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.
Lithuanian: Be to, kadangi išvados dėl variacijos buvo pateiktos tuo pat metu, kai buvo vykdoma peržiūra PRAC, nuspręsta, kad išvados dėl variacijos neprieštarauja ES lygmeniu tuo metu vykdytos peržiūros rezultatams.
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.
Lithuanian: Be to, CHMP atkreipė dėmesį tai, kad PRAC vertinimo protokole įgyvendinti ne visi Multihance (gadobeno rūgšties) pakuotės lapelio pakeitimai; teisinga formuluotė pateikta šios nuomonės priede.
English: PRAC conclusions on grounds for re-examination
Lithuanian: PRAC išvados dėl pagrindo pakartotinai išnagrinėti priimtą nuomonę
English: For gadobenic acid, the available studies do not establish differences in relaxivity, image quality and technical performance.
Lithuanian: Kalbant apie gadobeno rūgštį, atlikti tyrimai nerodo jokių relaksuojamumo, vaizdų kokybės ir techninės kokybės skirtumų.
English: Population-specific indication for Multihance
Lithuanian: Su konkrečiomis populiacijomis susijusi Multihance indikacija
English: 1 ICP-MS: Inductively coupled plasma mass spectrometry
Lithuanian: 1 ISP-MS - induktyviai susietos plazmos masių spektrometrija.
English: Data from the clinical post-mortem studies are heterogeneous and it is therefore difficult to compare the levels.
Lithuanian: Klinikinių post mortem tyrimų duomenys yra heterogeniški, todėl sunku palyginti šių medžiagų koncentracijas.
English: These effects might be delayed and subtle.
Lithuanian: Šis poveikis gali pasireikšti vėliau ir gali būti vos pastebimas.
English: 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.
Lithuanian: Be to, vadovaujantis šia nuomone, būtų svarbu įgyvendinant šią strategiją taip pat geriau informuoti sveikatos priežiūros specialistus, ypač praktikuojančius gydytojus, kurie reikalauja atlikti vaizdinimo tyrimus, apie kontrastinių medžiagų pasirinkimą, atsižvelgiant į skirtingas ligas ir indikacijas, kad jie apskritai būtų geriau informuoti apie naudos ir rizikos santykio analizę.
English: Another group of experts supported the view that macrocyclic agents are more stable and are preferable as first line contrast agents.
Lithuanian: Kita ekspertų grupė pritarė nuomonei, kad makrociklinės struktūros medžiagos yra stabilesnės ir jas reikėtų naudoti kaip pirmos eilės kontrastines medžiagas.
English: Many of these are common but typically non-serious reactions, such as rash, urticaria, and flushing.
Lithuanian: Daugelis iš jų - tai dažnos, bet paprastai nesunkios reakcijos, kaip antai bėrimas, urtikarija ir raudonis.
English: In view of available observational data which did not confirm a risk related to Gd accumulation in the brain so far, the PRAC considered that:
Lithuanian: Atsižvelgdamas į turimus stebimųjų tyrimų duomenis, kuriais lig šiol nepavyko patvirtinti su gadolinio kaupimusi galvos smegenyse susijusios rizikos, PRAC laikėsi nuomonės, kad:
English: Particularly zinc, copper and iron (Frenzel et al., 2008) are described as competing metals which can liberate Gd; glycosaminoglycans like heparin may bind Gd and thereby remove it from its pharmacological chelator.
Lithuanian: Visų pirma cinkas, varis ir geležis (Frenzel et al., 2008) yra apibūdinami kaip konkuruojantys metalai, kurie gali išlaisvinti gadolinį; tokie glikozaminoglikanai kaip heparinas gali prisijungti gadolinį ir taip pašalinti jį iš jo farmakologinio chelatoriaus.
English: In addition, macrocyclic agents are associated with a low risk of NSF.
Lithuanian: Be to, makrociklinės struktūros medžiagos siejamos su nedidele NSF rizika.
English: Gadolinium containing contrast agents (GdCAs) are complexes of paramagnetic gadolinium (III) with different types of organic chelators.
Lithuanian: Kontrastinės medžiagos su gadoliniu (KMG) yra paramagnetinio gadolinio (III) kompleksai su įvairių rūšių organiniais chelatoriais.