FrancophonIA/ELRC3.0 huggingface dataset:
English: Aristo Pharma Gmbh (Art 57) Ciprofloxacin Aristo
Estonian: Aristo Pharma Gmbh (Art 57) Ciprofloxacin Aristo Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 500 mg tablett
English: Solution For Injection/Infusion
Estonian: Süste-/infusioonilahus Intravenoosne
English: Norfloxacine Mylan Norfloxacin 400mg Tablet
Estonian: Norfloxacine Mylan Norfloksatsiin, 400 mg tablett Õhukese polümeerikattega tablett
English: Ciprofloxacin Hydrochloride 582mg Tablet
Estonian: Ciprofloxacina Teva Tsiprofloksatsiinhüdrokloriid, 582mg tablett
English: Levofloxacin Hetero Levofloxacin Hemihydrate 256.23mg Tablet
Estonian: Levofloxacin Hetero Levofloksatsiinhemihüdraat, 256,23 mg tablett
English: Moxifloxacin Hydrochloride 437mg/250 Ml
Estonian: Stada Arzneimittel Gmbh Moxifloxacin Stada Moksüfloksatsiinhüdrokloriid 437 mg/250 ml
English: Ciprofloxacin Lactate 127mg/50 Ml
Estonian: Tsiprofloksatsiinlaktaat 127 mg/50 ml
English: Ofloxacin 400mg Tablet
Estonian: Ofloxacine Mylan Ofloksatsiin, 400mg tablett
English: Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 250mg Tablet
Estonian: Ciprofloxacin Actavis Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 250mg tablett
English: Moxifloxacin Double-E Pharma
Estonian: Moxifloxacin DoubleE Pharma
English: Moxifloxacina Cinfa
Estonian: Moxifloxacin Noridem
English: Norfloxacino Sandoz Norfloxacin 400mg Tablet
Estonian: Norfloxacino Sandoz Norfloksatsiin, 400 mg tablett Õhukese polümeerikattega tablett
English: Lomefloxacin Hydrochloride 400mg Tablet
Estonian: Lomefloksatsiinhüdrokloriidi 400 mg tablett
English: Ciprofloxacin Hydrochloride Monohydrate 291mg Capsule
Estonian: Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 291 mg kapsel
English: Levofloxacina Arena Levofloxacin Hemihydrate 512.46mg Tablet
Estonian: Levofloxacina Arena Levofloksatsiinhemihüdraat, 512,46 mg tablett
English: Ciprofloxacin Hydrochloride 291.19mg Tablet
Estonian: Tsiprofloksatsiinhüdrokloriid, 291,19mg tablett
English: Moxifloxacin Hydrochloride 436.37mg Tablet
Estonian: Moxifloxacin Actavis Moksüfloksatsiinhüdrokloriid, 436,37 mg tablett
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 512.46mg Tablet
Estonian: Levofloxacine Pch Levofloksatsiinhemihüdraat, 512,46mg tablett
English: Moksifloksacin Stada Moxifloxacin 400mg/250 Ml
Estonian: Moxifloxacin Stada Moksüfloksatsiin 400 mg/250 ml Infusioonilahus
English: Levofloxacină Actavis Levofloxacin 5mg/Ml
Estonian: Levofloxacin Actavis Levofloksatsiin 5 mg/ml
English: Czech Republic +pharma Arzneimittel Gmbh Levofloxacin +pharma Levofloxacin Hemihydrate 512.46mg Tablet
Estonian: Cooper S.A. Pharmaceuticals Levofloxacin Cooper Levofloksatsiinhemihüdraat 5,1246 mg
English: Ciprofloxacin Hydrochloride 500mg Tablet
Estonian: Ciprofloxacina Alter Tsiprofloksatsiinhüdrokloriid, 500mg tablett
English: Ciprofloxacin Hydrochloride Monohydrate 582mg/Ml
Estonian: Tsiprofloksatsiinhüdrokloriidmon ohüdraat 582 mg/ml
English: Ciprofloxacina Wynn Ciprofloxacin Hydrochloride 291mg Tablet
Estonian: Ciprofloxacina Wynn Tsiprofloksatsiinhüdrokloriid, 291mg tablett
English: Ciprofloxacin Hydrated 500mg/5 Ml
Estonian: Hüdraaditud tsiprofloksatsiin 500 mg/5 ml
English: Norfloxacina Sandoz Norfloxacin 400mg Tablet
Estonian: Norfloxacina Sandoz Norfloksatsiin, 400 mg tablett Õhukese polümeerikattega tablett
English: Norfloxacino Normon Norfloxacin 400mg Tablet
Estonian: Norfloxacina Arena Norfloksatsiin, 400 mg kapsel
English: Ciprofloxacina Pensa Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Estonian: Ciprofloxacina Pensa Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 500 mg tablett
English: Ciprofloxacine Pch Ciprofloxacin Hydrochloride Monohydrate 750mg Tablet
Estonian: Ciprofloxacine Pch Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 750mg tablett
English: Norfloxacine Sandoz Norfloxacin 400mg Tablet
Estonian: Norfloxacine Sandoz Norfloksatsiin, 400 mg tablett Õhukese polümeerikattega tablett
English: Accord Healthcare France Sas Ciprofloxacine Accord Ciprofloxacin 500mg Tablet
Estonian: Madalmaad Accord Healthcare Limited Ciprofloxacine Accord Tsiprofloksatsiin, 500 mg tablett Õhukese polümeerikattega tablett
English: Levofloxacin Ibisqus Levofloxacin 5mg/Ml
Estonian: Levofloxacin Ibisqus Levofloksatsiin 5 mg/ml
English: Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 500mg Tablet
Estonian: Bluefish Pharmaceuticals Ab Levofloxacin Bluefish
English: Ciprofloxacin Alvogen Ciprofloxacin Hydrochloride 500mg Tablet
Estonian: Ciprofloxacino Cinfa Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 500 mg tablett
English: Moxifloxacin Teva Uk Moxifloxacin 400mg Tablet
Estonian: Moxifloxacin Teva Uk Moksüfloksatsiin, 400 mg tablett Õhukese polümeerikattega tablett
English: Ciprofloxacina Jaba
Estonian: Ciprofloxacina Ranbaxy
English: Ciprofloxacin Lactate 2.544mg/Ml
Estonian: Ciprofloxacin Claris Tsiprofloksatsiinlaktaat 2,544 mg/ml
English: Ciprofloxacina Abc
Estonian: Ciprofloxacine Apotex
English: Ciprofloxacin Teva Uk Ciprofloxacin Hydrochloride 750mg Tablet
Estonian: Ciprofloxacine Teva Tsiprofloksatsiinhüdrokloriid, 750 mg tablett
English: Moxifloxacin Acino
Estonian: Moxifloxacino Actavis
English: Ciprofloxacin Lactate 100mg/10 Ml
Estonian: Tsiprofloksatsiinlaktaat 100 mg/10 ml
English: Strides Shasun Uk Limited
Estonian: Ühendkuningriik Strides Shasun Uk Limited Ciprofloxacin CoPharma Limited
English: Amneal Pharma Europe Limited Ciprofloxacin Amneal
Estonian: Accord Healthcare Limited Ciprofloxacina Accord
English: Norfloxacino Pensa
Estonian: Norfloxacino Qualigen
English: Levofloxacin Actavis Levofloxacin 500mg Tablet
Estonian: Levofloxacin Actavis Levofloksatsiinhemihüdraat, 500 mg tablett
English: Ciprofloxacin Hydrochloride 873.3mg Tablet
Estonian: Tsiprofloksatsiinhüdrokloriid, 873,3 mg tablett
English: Ciprofloxacin Hydrochloride 291.5mg Tablet
Estonian: Tsiprofloksatsiinhüdrokloriid, 291,5mg tablett
English: Levofloxacino Aurovitas Levofloxacin Hemihydrate 500mg Tablet
Estonian: Levofloxacino Mabo Levofloksatsiinhemihüdraat, 500 mg tablett
English: Levofloxacin Arcana Levofloxacin 250mg/50 Ml
Estonian: Arcana Arzneimittel Gmbh Levofloxacin Arcana Levofloksatsiin 250 mg/50 ml
English: Ofloxacină Laropharm Ofloxacin 200mg Tablet
Estonian: Ofloxacine Arrow Ofloksatsiin, 200 mg tablett
English: Laboratorios Serra Pamies S.A. Levofloxacino Serraclinics
Estonian: Aurobindo Pharma Gmbh Levofloxacin Aurobindo
English: Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 250mg Tablet
Estonian: Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Tsiprofloksatsiinhüdrokloriid, 250 mg tablett
English: Amneal Pharma Europe Limited Levofloxacin Amneal
Estonian: Accord Healthcare Limited Levofloxacina Combino
English: Ciprofloxacin Hydrochloride 582.2mg Tablet
Estonian: Tsiprofloksatsiinhüdrokloriid, 582,2 mg tablett
English: Levofloxacin Generics Levofloxacin Hemihydrate 5mg/ml
Estonian: Levofloxacina Mylan Levofloksatsiinhemihüdraat 5mg/ml
English: Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 500mg Tablet
Estonian: Bluefish Pharmaceuticals Ab Levofloxacina Bluefish
English: Norfloxacin Laropharm Norfloxacin 400mg Tablet
Estonian: Norfloxacina Abc Norfloksatsiin, 400 mg kapsel
English: Moxifloxacin Hydrochloride 436.32mg Tablet
Estonian: Moxifloxacin Puren Moksüfloksatsiinhüdrokloriid, 436,32 mg tablett
English: Accord Healthcare Limited
Estonian: Accord Healthcare Limited Levofloxacina Accord
English: Ciprofloxacino Anages Ciprofloxacin 2mg/Ml
Estonian: Ciprofloxacin Claris Tsiprofloksatsiin 2 mg/ml
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 256.23mg Tablet
Estonian: Levofloxacine Pch Levofloksatsiinhemihüdraat, 256,23 mg tablett
English: Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 583mg Tablet
Estonian: Ciprofloxacina Almus Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 583mg tablett
English: Netherlands Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 500mg Tablet
Estonian: Madalmaad Bluefish Pharmaceuticals Ab Levofloxacin Bluefish
English: Ofloxacine Almus
Estonian: Ofloxacină Laropharm
English: Ciprofloxacin Genericon Ciprofloxacin Hydrochloride 582mg Tablet
Estonian: Ciprofloxacina Krka Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 582mg tablett
English: Ciprofloxacina Generis Ciprofloxacin Hydrochloride 291mg Tablet
Estonian: Ciprofloxacina Krka Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 291mg tablett
English: Ciprofloxacina Germed Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Estonian: Ciprofloxacina Krka Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 873mg tablett
English: Levofloxacine Almus Levofloxacin Hemihydrate 512.46mg Tablet
Estonian: Levofloxacine Almus Levofloksatsiinhemihüdraat, 512,46 mg tablett
English: Levofloxacin Pharma Resources
Estonian: Ühendkuningriik Pharma Resources Gmbh Levofloxacin Pharma Resources
English: Nalidixic Acid Remedica Nalidixic Acid 500mg Tablet
Estonian: Nalidixic Acid Remedica
English: Ciprofloxacina Generis Ciprofloxacin Hydrochloride 873mg Tablet
Estonian: Ciprofloxacina Teva Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 873mg tablett
English: Ciprofloxacin Orion Ciprofloxacin 250mg Tablet
Estonian: Ciprofloxacin Orion Tsiprofloksatsiin, 250 mg tablett Õhukese polümeerikattega tablett
English: Ciprofloxacin Hydrochloride 873mg Tablet
Estonian: Tsiprofloksatsiinhüdrokloriid, 873mg tablett
English: Norfloxacin 400mg Tablet
Estonian: Norfloksatsiin, 400 mg tablett Kattega tablett
English: Levofloxacin Hemihydrate 5.125mg/Ml
Estonian: Levofloksatsiinhemihüdraat 5,12mg/ml
English: Ciprofloxacin Teva Uk Ciprofloxacin Lactate 2mg/Ml
Estonian: Ciprofloxacin Teva Tsiprofloksatsiin 2 mg/ml
English: Norfloxacin 400mg Capsule Capsule
Estonian: Ofloksatsiin, 400 mg kapsel
English: Levofloxacino Mabo
Estonian: Levofloxacino Ranbaxy
English: Ciprofloxacine Alter
Estonian: Ciprofloxacin Alvogen
English: Netherlands Accord Healthcare Limited
Estonian: Madalmaad Accord Healthcare Limited Ciprofloxacine Accord
English: Ciprofloxacina Generis Ciprofloxacin Hydrochloride 582mg Tablet
Estonian: Ciprofloxacina Teva Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 582mg tablett
English: Ciprofloxacin Mylan Ciprofloxacin 750mg Tablet
Estonian: Ciprofloxacine Mylan Tsiprofloksatsiinhüdrokloriid, 750 mg tablett
English: Ciprofloxacin Medreich Ciprofloxacin Hydrochloride 582mg Tablet
Estonian: Ciprofloxacin Abz Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 583mg tablett
English: Levofloxacin Sandoz Levofloxacin 500mg Tablet
Estonian: Levofloxacin Sandoz Levofloksatsiin, 500 mg tablett Õhukese polümeerikattega tablett
English: Ciprofloxacin Hydrochloride 586mg Tablet
Estonian: Tsiprofloksatsiinhüdrokloriid, 586 mg tablett
English: Levofloxacin Actavis Levofloxacin Hemihydrate 500mg Tablet
Estonian: Levofloxacino Alter Levofloksatsiinhemihüdraat, 500 mg tablett
English: Norfloxacin 1 A Pharma Norfloxacin 400mg Tablet
Estonian: Norfloxacina Cinfa Norfloksatsiin, 400 mg tablett Kattega tablett
English: Ciprofloxacino Alter
Estonian: Ciprofloxacino Tevagen
English: Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Estonian: Ciprofloxacina Almus Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 873mg tablett
English: Norfloxacino Qualigen Norfloxacin 400mg Tablet
Estonian: Norfloxacino Pensa Norfloksatsiin, 400 mg tablett Õhukese polümeerikattega tablett
English: Ciprofloxacina Zentiva Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Estonian: Ciprofloxacin Abz Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 291,5mg tablett
English: Ciprofloxacin Hydrochloride Monohydrate 291.5µg Tablet
Estonian: Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 291,5 µg tablett
English: Moxifloxacin 400mg Tablet
Estonian: Moxifloxacin Actavis Moksüfloksatsiin, 400 mg tablett
English: Moxifloxacine Mylan Moxifloxacin 400mg Tablet
Estonian: Moxifloxacina Mylan Moksüfloksatsiin, 400 mg tablett
English: Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 500mg Tablet
Estonian: Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Tsiprofloksatsiinhüdrokloriid, 500 mg tablett
English: Levofloxacino Accord Levofloxacin Hemihydrate 512.46mg Tablet
Estonian: Accord Healthcare Limited Levofloxacin Accord Levofloksatsiinhemihüdraat 512,46 mg tablett
English: Ciprofloxacino Ratio Ciprofloxacin 250mg Tablet
Estonian: Ciprofloxacino Ratio Tsiprofloksatsiin, 250 mg tablett Õhukese polümeerikattega tablett
English: Levofloxacina Doc
Estonian: Levofloxacina Hospira
English: Levofloxacin Sandoz Levofloxacin 250mg Tablet
Estonian: Levofloxacin Sandoz Levofloksatsiin, 250 mg tablett Õhukese polümeerikattega tablett
English: Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Estonian: Ciprofloxacin Actavis Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 500 mg tablett
English: Levofloxacina Tecnigen Levofloxacin 250mg Tablet
Estonian: Levofloxacina Doc Levofloksatsiinhemihüdraat, 250 mg tablett
English: Ciprofloxacin Hydrochloride 291mg Tablet
Estonian: Tsiprofloksatsiinhüdrokloriid, 291mg tablett
English: Levofloxacina Germed Levofloxacin Hemihydrate 512.46mg Tablet
Estonian: Levofloxacina Get Levofloksatsiinhemihüdraat, 512,46mg tablett
English: Ciprofloxacin Hydrochloride 291.1mg Tablet
Estonian: Ciprofloxacin Ksk Tsiprofloksatsiinhüdrokloriidmon ohüdraat, 291,1mg tablett
English: Ciprofloxacin Mylan Ciprofloxacin 250mg Tablet
Estonian: Ciprofloxacine Mylan Tsiprofloksatsiinhüdrokloriid, 250 mg tablett
English: 250mg Tablet
Estonian: Levofloksatsiinhemihüdraat, 250mg tablett
English: All animals should have had water from the same source
Estonian: Kõik loomad oleksid pidanud vett saama samast kohast.
English: Fatalities are extremely rare.
Estonian: Surmajuhtumeid esineb äärmiselt harva.
English: The authors could not provide a sound explanation for this.
Estonian: Autorid ei suutnud seda usaldusväärselt selgitada.
English: Therefore this statement is not maintained.
Estonian: Seetõttu see väide kustutatakse.
English: Other safety aspects
Estonian: Muud ohutusaspektid
English: Therefore the condition should not mention “including the brains in human.”
Estonian: Seetõttu ei peaks tingimus sisaldama sõnu „sealhulgas inimese peaajus“.
English: Nephrogenic systemic fibrosis (NSF)
Estonian: Nefrogeenne süsteemne fibroos (NSF)
English: • The practical implementation of these measures is moreover not deemed feasible in a clinical setting.
Estonian: • Samuti ei peeta nende meetmete praktilist rakendamist kliinilises olukorras teostatavaks.
English: Such long-term safety studies are unlikely to be feasible within reasonable period of time.
Estonian: Selliste pikaajaliste ohutusuuringute tegemine mõistliku aja jooksul ei ole tõenäoliselt võimalik.
English: The experts at the ad-hoc expert meeting shared these same views.
Estonian: Ajutise eksperdirühma koosolekul osalenud eksperdid jagasid samu vaateid.
English: Premedication with antihistamines and corticosteroids could also be applied.
Estonian: Kasutada võib ka premedikatsiooni antihistamiinide ja kortikosteroididega.
English: Additionally, it is not possible to define a period of time during which no potential adverse effect would have time to manifest.
Estonian: Peale selle ei ole võimalik määratleda ajavahemikku, mille jooksul ei jõua ilmneda ükski võimalik kõrvaltoime.
English: Detailed conclusions from the meeting can be found in the enclosure 11 to the PRAC assessment report.
Estonian: Koosoleku üksikasjalikud järeldused on esitatud ravimiohutuse riskihindamise komitee aruande 11. lisas.
English: Neither would the introduction of educational material address this issue.
Estonian: Samuti ei lahenda seda küsimust teabematerjalide kasutamine.
English: 1 ICP-MS: Inductively coupled plasma mass spectrometry
Estonian: 1 ICP-MS (inductively coupled plasma mass spectrometry): induktiivsidestunud plasma mass-spektromeetria
English: In addition, the repeated use of these products is most unlikely.
Estonian: Peale selle on nende kontrastainete korduv kasutamine väga vähetõenäoline.
English: Although in patients with a history of drug allergy the reaction risk might be increased, the risk is still very low.
Estonian: Kuigi ravimiallergia anamneesiga patsientidel võib reaktsiooni tekkerisk olla suurem, on risk ikkagi väga väike.
English: This clearly indicates that potential dechelation in the body is a recognised phenomenon.
Estonian: See näitab selgesti, et organismis toimuv potentsiaalne kelaadist vabanemine on tuntud nähtus.
English: These effects might be delayed and subtle.
Estonian: Need kahjulikud toimed võivad olla hilised ja vähe väljendunud.
English: Particularly, it was stated that the influence on patient management was not directly demonstrated by the study results.
Estonian: Eriti märgiti, et uuringutulemused ei tõendanud otseselt mõju patsientide käsitlemisele.
English: National assessment
Estonian: Riiklik hindamine
English: In case such studies were however to be carried out, patients would bear the risks as long as ongoing research is not completed.
Estonian: Kui sellised uuringud siiski tehakse, on patsiendid uuringu lõpuni endiselt riskidest ohustatud.
English: Interventional clinical studies comparing the different products could be considered unethical.
Estonian: Eri kontrastaineid võrdlevaid kliinilisi sekkumisuuringuid võib pidada ebaeetiliseks.
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.
Estonian: Seda asjaolu arutati ajutise eksperdirühma koosolekul kliiniliste ekspertidega, kes kinnitasid seose võimalikkust, kuid see on seni veel tõendamata.
English: The vast majority of these reactions are non-serious, with a very low percentage of patients experiencing severe hypersensitivity reactions.
Estonian: Enamik neist reaktsioonidest ei ole tugevad ning raskeid ülitundlikkusreaktsioone esineb väga väikesel protsendil patsientidest.
English: Another group of experts supported the view that macrocyclic agents are more stable and are preferable as first line contrast agents.
Estonian: Teine eksperdirühm toetas arvamust, et makrotsüklilised ained on stabiilsemad ja esimese valiku kontrastainetena eelistatavad.
English: Data from the clinical post-mortem studies are heterogeneous and it is therefore difficult to compare the levels.
Estonian: Surmajärgsete kliiniliste uuringute andmed on heterogeensed ja seega on kontsentratsioonide võrdlemine keerukas.
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.
Estonian: • T1-signaali kuju ja suurus on oluliselt teistsugune kui kahes varasemas publikatsioonis (Jost et al., 2016, ja Robert et al., 2015) teatatud signaali kuju ning ei ole täiesti selge, kas intensiivsema signaali piirkond tõepoolest vastab hammastuumale või on tegu muu ajupiirkonnaga.
English: In non-clinical studies (Robert et al. 2016 Lohrke et al. 2015; Lohrke et al. 2016; Kartamihardja et al. 2016a; Kartamihardja et al. 2016b; Smith et al. 2017; Rasschaert et al. 2016; MAH unpublished studies) the levels were typically around 10-fold higher with linear agents.
Estonian: Mittekliinilistes uuringutes (Robert et al., 2016; Lohrke et al., 2015; Lohrke et al., 2016; Kartamihardja et al., 2016a; Kartamihardja et al., 2016b; Smith et al., 2017; Rasschaert et al., 2016; müügiloa hoidja avaldamata uuringud) oli kontsentratsioon lineaarsete kontrastainete korral tüüpiliselt ligikaudu 10 korda suurem.
English: In accordance with Article 107k of Directive 2001/83/EC, the CHMP considered the PRAC recommendation adopted on 6 July 2017.
Estonian: Kooskõlas direktiivi 2001/83/EÜ artikliga 107k arutas inimravimite komitee ravimiohutuse riskihindamise komitee 6. juulil 2017 vastu võetud soovitust.
English: It should be noted that McDonald et al. (2017) reported very little Gd deposition.
Estonian: Tuleb märkida, et uuringus McDonald et al. (2017) teatati väga vähesest gadoliiniumi ladestumisest.
English: In general, appropriate medications, equipment and staff experienced in the management of hypersensitivity reactions can be expected in any radiological practice.
Estonian: Üldiselt on sobivad ravimid, varustus ja ülitundlikkusreaktsioonide käsitlemise kogemusega personal eeldatavalt olemas kõigis radioloogiaosakondades.
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).
Estonian: Komplekside lagunemine arvatakse olevat seotud gadoliiniumi sisaldavate kontrastainete eri tüüpi komplekside erineva stabiilsusega (Spencer et al., 1997).
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.
Estonian: Samuti ei pruugi radioloogi patsiendidokumentatsioonis olla täielikult dokumenteeritud kasutuskordade sagedus ja aeg ja/või ei pruugi see teave olla kättesaadav radioloogile või perearstile tulevikus, sest patsient võib elukoha muutuse või muude põhjuste tõttu olla mitu korda vahetanud radioloogi/perearsti.
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.
Estonian: Ravimiohutuse riskihindamise komitee oli siiski arvamusel, et peaajju akumuleerumise ja selle kliiniliste tagajärgede teavet peab sobivas raamistikus edasi uurima, seega on vaja vaadata andmed läbi Euroopa Liidu tasandil.
English: PRAC considered that it is highly unlikely that the release of Gd from gadodiamide is slower in vivo than in vitro.
Estonian: Komitee oli arvamusel, et on äärmiselt vähetõenäoline, et gadoliiniumi vabanemine gadodiamiidist on in vivo aeglasem kui in vitro.
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.
Estonian: Ravimiohutuse riskihindamise komitee oli arvamusel, et uuring McDonald et al. ei muutnud nende varasemaid järeldusi, ja märkis, et seda arvamust toetab ka 19. juunil kogunenud ajutine eksperdirühm.
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.
Estonian: Pärast ravimiohutuse riskihindamise komitee soovituse vastuvõtmist komitee 2017. aasta märtsi koosolekul teatasid kaks müügiloa hoidjat (Bracco ja GE Healthcare), et nad ei nõustu komitee esialgse soovitusega.
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.
Estonian: Need piirkonnad osalevad tahtlike ja tahtmatute liigutuste reguleerimisel, mistõttu kõrvalnähud võivad potentsiaalselt olla näiteks ataksia, treemorid ja muud liikumishäired.
English: These observations leave the possibility that the method used for the Gd determination is unreliable under certain circumstances.
Estonian: Nende tähelepanekute tõttu on võimalik, et gadoliiniumi määramise meetod ei ole teatud tingimustel usaldusväärne.
English: • No specific patient group with less risk of accumulation in the brain can currently be identified.
Estonian: • Praegu ei ole tuvastatud ühtki spetsiifilist patsiendirühma, kellel peaajju akumuleerumise risk oleks väiksem.