FrancophonIA/ELRC3.0 huggingface dataset:
English: Ciprofloxacin Teva Uk Ciprofloxacin Hydrochloride 750mg Tablet
Latvian: Ciprofloxacine Teva Ciprofloksacīna hidrohlorīds 750 mg tablete
English: Levofloxacine B. Braun Levofloxacin 5mg/Ml
Latvian: Levofloxacin B. Braun Levofloksacīns 5 mg/ml
English: Norfloxacino Sandoz Norfloxacin 400mg Tablet
Latvian: Norfloxacin Sandoz Norfloksacīns 400 mg tablete Apvalkota tablete
English: Ciprofloxacin Hydrochloride Monohydrate 222mg/100 Ml
Latvian: Ciprofloksacīna hidrohlorīds 222 mg/100 ml
English: Ciprofloxacină Arena Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacină Arena Ciprofloksacīns 500 mg tablete
English: Ciprofloxacina Sandoz Ciprofloxacin 750mg Tablet
Latvian: Ciprofloxacina Sandoz Ciprofloksacīns 750 mg tablete
English: Ciprofloxacin Milpharm Ciprofloxacin 750mg Tablet
Latvian: Ciprofloxacin Milpharm Ciprofloksacīns 750 mg tablete
English: Ciprofloxacin Orion Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacin Orion Ciprofloksacīns 500 mg tablete
English: Moxifloxacin Hydrochloride 437mg/250 Ml
Latvian: Moksifloksacīna hidrohlorīds 437 mg/250 ml
English: Ciprofloxacin Hydrochloride 250mg Tablet
Latvian: Ciprofloxacin Human Ciprofloksacīna hidrohlorīds 250 mg tablete
English: Ciprofloxacina Zentiva Ciprofloxacin Hydrochloride Monohydrate 291.5mg Tablet
Latvian: Ciprofloxacina Teva Ciprofloksacīna hidrohlorīda monohidrāts 291 mg tablete
English: Levofloxacin Hetero Levofloxacin Hemihydrate 256.23mg Tablet
Latvian: Levofloxacina Hetero Levofloksacīna hemihidrāts 256,23mg tablete
English: Pipemidic Acid 400mg Capsule Capsule, Hard
Latvian: Ofloksacīns 400 mg, kapsula Kapsula, cietā
English: Ciprofloxacina Zentiva Ciprofloxacin Hydrochloride Monohydrate 583mg Tablet
Latvian: Ciprofloxacina Almus Ciprofloksacīna hidrohlorīda monohidrāts 583 mg tablete
English: Ciprofloxacin Arcana Ciprofloxacin Hydrochloride 500mg Tablet
Latvian: Arcana Arzneimittel Gmbh Ciprofloxacin Arcana Ciprofloksacīna hidrohlorīds 500 mg tablete
English: Ciprofloxacin Sandoz Ciprofloxacin 750mg Tablet
Latvian: Ciprofloxacin Sandoz Ciprofloksacīns 750 mg tablete
English: Levofloxacino Ranbaxy Levofloxacin 500mg Tablet
Latvian: Levofloxacine Ranbaxy Levofloksacīns 500 mg tablete
English: Ciprofloxacin Orion Ciprofloxacin 250mg Tablet
Latvian: Ciprofloxacin Orion Ciprofloksacīns 250 mg tablete
English: Levofloxacin Hemihydrate 5.12mg/Ml
Latvian: Levofloxacine Arrow Levofloksacīna hemihidrāts 5,12 mg/ml
English: Moxifloxacino Apotex Moxifloxacin Hydrochloride 436.33mg Tablet
Latvian: Moxifloxacino Apotex Moksifloksacīna hidrohlorīds 436,33 mg tablete
English: Ciprofloxacina Sandoz Ciprofloxacin Hydrochloride Monohydrate 500mg Tablet
Latvian: Ciprofloxacina Sandoz Ciprofloksacīna hidrohlorīda monohidrāts 500 mg tablete
English: Ciprofloxacin Hydrochloride 500mg Tablet
Latvian: Ciprofloxacine Mylan Ciprofloksacīna hidrohlorīds 500 mg tablete
English: Levofloxacine Arrow Levofloxacin 250mg/50 Ml
Latvian: Levofloxacine Arrow Levofloksacīns 250 mg/50 ml
English: Levofloxacin Sandoz Levofloxacin 5mg/Ml
Latvian: Levofloxacin Sandoz Levofloksacīns 5 mg/ml
English: Moxifloxacin Orion Moxifloxacin 400mg Vial
Latvian: Moxifloxacin Orion Moksifloksacīns 400 mg pudele
English: Levofloxacino B. Braun Levofloxacin 500mg/100 Ml
Latvian: Levofloxacino B. Braun Levofloksacīns 500 mg/100 ml
English: Norfloxacina Sandoz Norfloxacin 400mg Tablet
Latvian: Norfloxacina Sandoz Norfloksacīns 400 mg tablete Apvalkota tablete
English: Levofloxacin Sandoz Levofloxacin 250mg Tablet
Latvian: Levofloxacin Sandoz Levofloksacīns 250 mg tablete
English: 512.46mg Tablet
Latvian: Levofloksacīna hemihidrāts 512,46mg tablete
English: Ciprofloxacino Tevagen Ciprofloxacin 750mg Tablet
Latvian: Ciprofloxacino Tevagen Ciprofloksacīns 750 mg tablete
English: Levofloxacina Zentiva Levofloxacin 250mg Tablet
Latvian: Levofloxacin Mylan Levofloksacīns 250 mg tablete
English: Ciprofloxacin Mylan Ciprofloxacin 250mg Tablet
Latvian: Ciprofloxacin Mylan Ciprofloksacīns 250 mg tablete
English: Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 291mg Tablet
Latvian: Ciprofloxacina Almus Ciprofloksacīna hidrohlorīda monohidrāts 291 mg tablete
English: Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Latvian: Ciprofloxacina Almus Ciprofloksacīna hidrohlorīda monohidrāts 582 mg tablete
English: Ciprofloxacine Sandoz Ciprofloxacin 750mg Tablet
Latvian: Ciprofloxacine Sandoz Ciprofloksacīns 750 mg tablete
English: Ciprofloxacina Sandoz Ciprofloxacin 250mg Tablet
Latvian: Ciprofloxacina Sandoz Ciprofloksacīns 250 mg tablete
English: Ciprofloxacín Sandoz Ciprofloxacin 250mg Tablet
Latvian: Ciprofloxacín Sandoz Ciprofloksacīns 250 mg tablete
English: Levofloxacina Combino Levofloxacin 500mg/100 Ml
Latvian: Accord Healthcare Limited Levofloxacina Combino Levofloksacīns 500 mg/100 ml
English: Levofloxacin Hemihydrate 5.125mg/Ml
Latvian: Levofloxacine Hospira Levofloksacīna hemihidrāts 5,125 mg/ml
English: Ciprofloxacin Hydrated 500mg/5 Ml
Latvian: Ciprofloksacīna hidrāts 500 mg/5 ml
English: Levofloxacina Germed Levofloxacin Hemihydrate 256.23mg Tablet
Latvian: Levofloxacina Germed Levofloksacīna hemihidrāts 256,23mg tablete
English: Moxifloxacin Hydrochloride 436.32mg Tablet
Latvian: Kg Moxifloxacin Puren Moksifloksacīna hidrohlorīds 436,32 mg tablete
English: Levofloxacin Hemihydrate 512.46mg Vial
Latvian: Levofloksacīna hemihidrāts 512,46mg flakons
English: Ciprofloxacino Pensa Ciprofloxacin 250mg Tablet
Latvian: Ciprofloxacino Pensa Ciprofloksacīns 250 mg tablete
English: Pefloxacin Mesilate 80mg/Ml
Latvian: Pefloksacīna mesilāts 80 mg/ml
English: Enoxacin 200mg Tablet
Latvian: Enoksacīns 200 mg tablete Apvalkota tablete
English: Moxifloxacin 400mg Tablet
Latvian: Moxifloxacin Mylan Moksifloksacīns 400 mg tablete
English: Ciprofloxacino Aristo Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacino Aristo Ciprofloksacīns 500 mg tablete
English: Ciprofloxacin Teva Uk Ciprofloxacin Hydrochloride 500mg Tablet
Latvian: Ciprofloxacin Teva Uk Ciprofloksacīna hidrohlorīds 500 mg tablete
English: Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloxacin 250mg Tablet
Latvian: Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloksacīns 250mg tablete Apvalkota tablete
English: Ciprofloxacina Mylan Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacina Mylan Ciprofloksacīns 500 mg tablete
English: Levofloxacin Hospira Levofloxacin 500mg/100 Ml
Latvian: Levofloxacin Hospira Levofloksacīns 500 mg/100 ml
English: Ciprofloxacino Tevagen Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacino Tevagen Ciprofloksacīns 500 mg tablete
English: Levofloxacina Zentiva Levofloxacin 500mg Tablet
Latvian: Levofloxacin Torrent Levofloksacīns 500 mg tablete
English: Ciprofloxacin Milpharm Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacin Milpharm Ciprofloksacīns 500 mg tablete
English: Levofloxacin Noridem Levofloxacin 5mg/Ml
Latvian: Levofloxacine Arrow Levofloksacīns 5 mg/ml
English: Levofloxacine Hospira Levofloxacin 250mg/50 Ml
Latvian: Levofloxacino Hospira Levofloksacīns 250 mg/50 ml
English: Moxifloxacina Sandoz Moxifloxacin 400mg Tablet
Latvian: Moxifloxacina Sandoz Moksifloksacīns 400 mg tablete
English: Moxifloxacin Noridem Moxifloxacin 1.6mg/Ml
Latvian: Moxifloxacin Noridem Moksifloksacīns 1,6 mg/ml
English: Ciprofloxacina Hikma Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Latvian: Ciprofloxacina Jaba Ciprofloksacīna hidrohlorīda monohidrāts 873 mg tablete
English: Ciprofloxacin Generics Ciprofloxacin 750mg Tablet
Latvian: Ciprofloxacin Generics Ciprofloksacīns 750 mg tablete
English: Moxifloxacin Hydrochloride 400mg Tablet
Latvian: Moxifloxacina Mylan Moksifloksacīns 400 mg tablete
English: Levofloksasiini Teva Levofloxacin 5mg/Ml
Latvian: Levofloxacin Infomed Levofloksacīns 5 mg/ml
English: Ciprofloxacin Mylan Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacine Mylan Ciprofloksacīns 500 mg tablete
English: Moxifloxacino Tevagen Moxifloxacin 400mg Tablet
Latvian: Moxifloxacino Tevagen Moksifloksacīns 400 mg tablete
English: Ciprofloxacin Hydrochloride 291.19mg Tablet
Latvian: Ciprofloksacīna hidrohlorīds 291,19 mg tablete
English: Ciprofloxacin Lyomark Ciprofloxacin Lactate 2.54mg/Ml
Latvian: Ciprofloxacin Lyomark Ciprofloksacīna laktāts 2,54 mg/ml
English: Ciprofloxacín Sandoz Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacín Sandoz Ciprofloksacīns 500 mg tablete
English: Ciprofloxacina Sandoz Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacina Sandoz Ciprofloksacīns 500 mg tablete
English: Levofloxacina Tecnigen Levofloxacin 500mg Tablet
Latvian: Levofloxacino Tecnigen Levofloksacīns 500 mg tablete
English: Norfloxacino Qualigen Norfloxacin 400mg Tablet
Latvian: Norfloxacino Qualigen Norfloksacīns 400 mg tablete Apvalkota tablete
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 512.46mg Tablet
Latvian: Levofloxacine Almus Levofloksacīna hemihidrāts 512,46 mg tablete
English: Ciprofloxacin Lactate 127.2mg/50 Ml
Latvian: Ciprofloksacīna laktāts 127,2 mg/50 ml
English: Ciprofloxacino Tarbis Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacino Tarbis Ciprofloksacīns 500 mg tablete
English: Levofloxacine Jubilant Levofloxacin Hemihydrate 256.23mg Tablet
Latvian: Levofloxacina Arena Levofloksacīna hemihidrāts 256,23mg tablete
English: Ciprofloxacin Sandoz Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacino Sandoz Ciprofloksacīns 500mg tablete
English: Ciprofloxacină Arena Ciprofloxacin 250mg Tablet
Latvian: Ciprofloxacină Arena Ciprofloksacīns 250 mg tablete
English: Ciprofloxacine Sandoz Ciprofloxacin 250mg Tablet
Latvian: Ciprofloxacine Sandoz Ciprofloksacīns 250 mg tablete
English: Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 250mg Tablet
Latvian: Ciprofloxacin Actavis Ciprofloksacīna hidrohlorīda monohidrāts 250 mg tablete
English: Levofloxacina Accord Levofloxacin Hemihydrate 512.46mg Tablet
Latvian: Accord Healthcare Limited Levofloxacina Accord Levofloksacīna hemihidrāts 512,46 mg tablete
English: Bluefish Pharmaceuticals Ab Levofloxacina Bluefish Levofloxacin 250mg Tablet
Latvian: Bluefish Pharmaceuticals Ab Levofloxacin Bluefish Levofloksacīns 250 mg tablete
English: Lomefloxacin Hydrochloride 400mg Tablet
Latvian: Moxifloxacin Sandoz Moksifloksacīna hidrohlorīds 400 mg tablete
English: Ciprofloxacina Almus Ciprofloxacin Hydrochloride Monohydrate 873mg Tablet
Latvian: Ciprofloxacina Almus Ciprofloksacīna hidrohlorīda monohidrāts 873 mg tablete
English: Levofloxacina Generis Levofloxacin Hemihydrate 256.23mg Tablet
Latvian: Levofloxacina Generis Levofloksacīna hemihidrāts 256,23 mg tablete
English: Ciprofloxacin Teva Uk Ciprofloxacin Lactate 2mg/Ml
Latvian: Ciprofloxacin Teva Uk Ciprofloksacīna laktāts 2 mg/ml
English: Ciprofloxacina Hikma Ciprofloxacin Hydrochloride Monohydrate 291.1mg Tablet
Latvian: Ciprofloxacina Jaba Ciprofloksacīna hidrohlorīda monohidrāts 291 mg tablete
English: Ciprofloxacin Hydrochloride 100mg Tablet
Latvian: Ciprofloxacin Stada Ciprofloksacīns 100 mg tablete
English: Ciprofloxacine Sandoz Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacine Sandoz Ciprofloksacīns 500 mg tablete
English: Levofloxacino Accord Levofloxacin Hemihydrate 512.46mg Tablet
Latvian: Accord Healthcare Limited Levofloxacin Accord Levofloksacīna hemihidrāts 512,46 mg tablete
English: Ciprofloxacino Stada Ciprofloxacin 500mg Tablet
Latvian: Ciprofloxacino Stada Ciprofloksacīns 500 mg tablete
English: Ciprofloxacino Normon Ciprofloxacin 2mg/Ml
Latvian: Ciprofloxacino Normon Ciprofloksacīns 2 mg/ml
English: Ciprofloxacin Actavis Ciprofloxacin Hydrochloride Monohydrate 750mg Tablet
Latvian: Ciprofloxacin Actavis Ciprofloksacīna hidrohlorīda monohidrāts 750 mg tablete
English: Ciprofloxacin Hydrochloride 582.2mg Tablet
Latvian: Ciprofloksacīna hidrohlorīds 582,2 mg tablete
English: Ciprofloxacin Accord Ciprofloxacin 750mg Tablet
Latvian: Accord Healthcare Limited Ciprofloxacin Accord Ciprofloksacīns 750 mg tablete
English: Levofloxacine B.Braun Levofloxacin 500mg/100 Ml
Latvian: Levofloxacina B. Braun Levofloksacīns 500 mg/100 ml
English: Ciprofloxacina Tecnigen Ciprofloxacin Hydrochloride Monohydrate 582mg Tablet
Latvian: Ciprofloxacina Teva Ciprofloksacīna hidrohlorīda monohidrāts 582 mg tablete
English: Ranbaxy Pharmacie Generiques Ofloxacine Ranbaxy Ofloxacin 200mg Tablet
Latvian: Ofloxacine Ranbaxy Ofloksacīns 200 mg tablete Apvalkota tablete
English: Ciprofloxacin Lactate 2.55mg/Ml
Latvian: Ciprofloksacīna laktāts 2,55 mg/ml
English: Levofloxacina Arena Levofloxacin Hemihydrate 512.46mg Tablet
Latvian: Levofloxacina Arena Levofloksacīna hemihidrāts 512,46 mg tablete
English: Ofloxacin 200mg/40 Ml
Latvian: Ofloksacīns 200 mg/40 ml
English: Ciprofloxacin Noridem Ciprofloxacin 2mg/Ml
Latvian: Ciprofloxacin Noridem Ciprofloksacīns 2 mg/ml
English: Levofloxacina Farmoz Levofloxacin 5mg/Ml
Latvian: Levofloxacina Farmoz Levofloksacīns 5 mg/ml
English: Ciprofloxacin Lactate 100mg/10 Ml
Latvian: Ciprofloxacina Zentiva Ciprofloksacīna laktāts 10 mg/ml
English: Ciprofloxacin Lactate 254.4mg/100 Ml
Latvian: Ciprofloksacīna laktāts 254,4 mg/100 ml
English: Fatalities are extremely rare.
Latvian: Nāves gadījumi ir ārkārtīgi reti.
English: All animals should have had water from the same source
Latvian: Visiem dzīvniekiem ūdeni vajadzēja saņemt no viena un tā paša avota.
English: Other safety aspects
Latvian: Citi drošuma aspekti
English: The authors could not provide a sound explanation for this.
Latvian: Autori tam nevarēja sniegt pamatotu skaidrojumu.
English: Therefore this statement is not maintained.
Latvian: Tādēļ šis apgalvojums netiek atbalstīts.
English: Therefore the condition should not mention “including the brains in human.”
Latvian: Tāpēc nosacījumā nedrīkst minēt “ieskaitot cilvēka smadzenēs”.
English: Nephrogenic systemic fibrosis (NSF)
Latvian: Nefrogēna sistēmiska fibroze (NSF)
English: In view of the above, the PRAC concluded that:
Latvian: Ņemot vērā iepriekš minēto, PRAC secināja:
English: These effects might be delayed and subtle.
Latvian: Šīs sekas var būt aizkavētas vai neizteiktas.
English: Neither would the introduction of educational material address this issue.
Latvian: To nespētu arī šīs problēmas novēršanai paredzētu izglītojošu materiālu iekļaušana.
English: Detailed conclusions from the meeting can be found in the enclosure 11 to the PRAC assessment report.
Latvian: Detalizēti sanāksmes secinājumi ir pieejami PRAC novērtējuma ziņojuma 11. pielikumā.
English: However, it demonstrates the complexity and difficulties associated with the objective of analysing potential neurological effects.
Latvian: Tomēr tas atklāj sarežģītību un grūtības, kas ir saistītas ar mērķi analizēt potenciālās neiroloģiskās sekas.
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.
Latvian: Tas tika apspriests ar klīniskajiem ekspertiem speciālās ekspertu grupas sanāksmes ietvaros, kas apstiprināja iespējamu saistību, taču tā vēl nav pierādīta.
English: In case such studies were however to be carried out, patients would bear the risks as long as ongoing research is not completed.
Latvian: Ja tomēr šādi pētījumi tiktu veikti, pacienti būtu pakļauti riskam līdz pat pētījuma beigām.
English: Such long-term safety studies are unlikely to be feasible within reasonable period of time.
Latvian: Šādi ilgtermiņa drošuma pētījumi samērīgā laika posmā nešķiet iespējami.
English: These observations leave the possibility that the method used for the Gd determination is unreliable under certain circumstances.
Latvian: Šie novērojumi pieļauj iespēju, ka Gd noteikšanai izmantotā metode noteiktos apstākļos ir neuzticama.
English: Premedication with antihistamines and corticosteroids could also be applied.
Latvian: Var izmantot premedikāciju ar antihistamīniem un kortikosteroīdiem.
English: Higher relaxivity of Multihance
Latvian: Augstāka Multihance relaksivitāte
English: • for clinically important benefits that are currently not established in an identified population or indication and which outweigh the risks related to the product.
Latvian: • par klīniski svarīgiem ieguvumiem, kas šobrīd nav konstatēti identificētajā populācijā vai indikācijā un kas pārspēj ar preparātu saistītos riskus.
English: The long-term clinical consequences of such gadolinium retention are currently unknown.
Latvian: Šādas gadolīnija saglabāšanās ilgtermiņa klīniskās sekas šobrīd nav zināmas.
English: Skin prick testing could facilitate the identification of an alternative GdCA.
Latvian: Ādas skarifikācijas tests varētu palīdzēt noteikt alternatīvu GdCA.
English: With these uncertainties, conclusions on different or similar behaviour of the different contrast agents studied by McDonald et al. are not possible.
Latvian: Ņemot vērā šo nenoteiktību, secinājumus par dažādu kontrastvielu atšķirīgu vai līdzīgu uzvedību, ko pētīja McDonald et al., izdarīt nav iespējams.
English: In addition, the repeated use of these products is most unlikely.
Latvian: Bez tam, atkārtota šo preparātu lietošana ir ļoti maz ticama.
English: Although in patients with a history of drug allergy the reaction risk might be increased, the risk is still very low.
Latvian: Lai gan pacientiem, kuriem anamnēzē ir alerģija uz zālēm, reakcijas risks var pastiprināties, šis risks ir ļoti zems.
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.
Latvian: Tādējādi PRAC atzina, ka McDonald pētījums nemainīja komitejas iepriekšējos secinājumus un norādīja, ka šo viedokli atbalsta arī speciālā ekspertu grupa, kas tikās 19. jūnijā.
English: Overall, the experts expressed divergent views concerning the risk minimisation measures.
Latvian: Kopumā eksperti par riska mazināšanas pasākumiem pauda atšķirīgus viedokļus.
English: The implemented risk minimisation measures appear to be effective based on annual reviews of spontaneous case reports.
Latvian: Šķiet, ka ieviestie riska mazināšanas pasākumi, pamatojoties uz ikgadējiem spontānu gadījumu ziņojumiem, ir efektīvi.
English: The vast majority of these reactions are non-serious, with a very low percentage of patients experiencing severe hypersensitivity reactions.
Latvian: Lielākā daļa šo reakciju nav nopietnas, ar ļoti nelielu daļu pacientu, kam ir novērojamas smagas paaugstināta jutības reakcijas.
English: The macrocyclic agent gadobutrol did not show hyperintensity after this time period.
Latvian: Makrocikliskā viela gadobutrols pēc šā laika perioda hiperintensitāti neuzrādīja.
English: The experts at the ad-hoc expert meeting shared these same views.
Latvian: Ekspertiem speciālās ekspertu grupas sanāksmē bija līdzīgs viedoklis.
English: The linear compounds therefore particularly persist in the brain.
Latvian: Tādēļ smadzenēs īpaši noturīgi ir lineārie savienojumi.
English: Interventional clinical studies comparing the different products could be considered unethical.
Latvian: Intervences klīniskos pētījumus, kuros salīdzina dažādus preparātus, var uzskatīt par neētiskiem.
English: These effects can be mimicked in vitro and will further diminish the stability of the GdCA complex in vivo.
Latvian: Šos rezultātus var imitēt in vitro, un tie vēl vairāk samazinās GdCA kompleksa stabilitāti in vivo apstākļos.
English: Data from the clinical post-mortem studies are heterogeneous and it is therefore difficult to compare the levels.
Latvian: Dati no klīniskajiem pētījumiem, kas veikti pēc nāves, ir neviendabīgi, un tādēļ ir grūti salīdzināt līmeņus.
English: Additionally, it is not possible to define a period of time during which no potential adverse effect would have time to manifest.
Latvian: Turklāt nav iespējams noteikt laika periodu, kurā nevarētu sākties jebkādas nelabvēlīgas blakusparādības.
English: It is not fully clear how reliable the method of Gd quantification in tissue was.
Latvian: Nav pilnībā skaidrs, cik uzticama bija metode Gd daudzuma noteikšanai audos.
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.
Latvian: Smith et al. 2017 aprakstīja, ka uzkrātais Gd aizvien samazinās pēc vienas nedēļas, tāpēc acīmredzami eksistē īslaicīgs uzkrājums, kas atšķiras no materiāla, kas saglabājas ilgstoši.
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.
Latvian: Ņemot vērā atsauci uz iepriekšējo novērtējumu, kas veikts valsts līmenī (II tipa variāciju Multihance indikāciju paplašināšanai, UK/H/0234/001-002/II/038), jānorāda, ka šā variācijas pieteikuma novērtējuma joma atšķīrās no 31. pantā noteiktās pārskatīšanas procedūras un tāpēc šīs divas procedūras ir balstītas uz dažādām datu kopām, kas ļauj pamatot dažādus rezultātus.
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.
Latvian: Neskatoties uz to un ņemot vērā reģistrācijas apliecības īpašnieku sniegto detalizēto pamatojumu, PRAC veica jaunu pieejamo datu novērtēšanu pārskatīšanas kontekstā.
English: • The practical implementation of these measures is moreover not deemed feasible in a clinical setting.
Latvian: • Šo pasākumu praktiskā ieviešana bez tam nešķiet iespējama klīnikas apstākļos.
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.
Latvian: PRAC atzina, ka otrajā ad hoc ekspertu sanāksmē bija jāizskata daži aspekti, kas veido daļu detalizētā pamatojuma, ko iesniedza Bracco un GE Healthcare.
English: Indeed there are two phases of liver MRI enhancement with GdCAs:
Latvian: Patiesībā ir divas aknu MRI uzlabošanas fāzes ar GdCA:
English: 1 ICP-MS: Inductively coupled plasma mass spectrometry
Latvian: 1 ICP-MS: Induktīvi sapārotas plazmas masspektrometrija
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).
Latvian: Uzskata, ka šī disociācija ir saistīta ar dažāda veida GdCA kompleksu stabilitātes atšķirībām (Spencer et al.
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.
Latvian: • T1 signāla forma un izmērs izteikti atšķiras no signāla formas, par ko ir ziņots divos jaunākos pētījumos (Jost et al., 2016, un Robert et al., 2015), un nav pilnībā skaidrs, vai pastiprinātā signāla apgabals tiešām atbilst DN vai kādam citam smadzeņu apgabalam.
English: • Gd retention was studied rather early (one week) after cessation of treatment so that detected Gd may not represent the long-term storage form.
Latvian: • Gd saglabāšanos pētīja diezgan agri (vienu nedēļu) pēc terapijas izbeigšanas, tāpēc atklātais Gd var nebūt ilgstošas uzkrāšanās formā.
English: The MAHs were also requested to update the safety specifications in the Risk Management Plans for these products to reflect these findings.
Latvian: Reģistrācijas apliecības īpašniekiem tika pieprasīts atjaunināt šo preparātu riska pārvaldības plānu drošuma specifikācijas, lai atspoguļotu šos atklājumus.
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.
Latvian: Bez tam, tā kā šī variācija tika pabeigta vienlaikus ar PRAC pārskatu, varēja saprast, ka notiekošās ES pārskatīšanas rezultāti nav ietekmējuši variācijas secinājumus.
English: • To complement the information in the SmPC with evidence-based educational programs;
Latvian: • Papildināt zāļu aprakstā esošo informāciju ar izglītojošām uz pierādījumiem balstītām programmām;