natgillin/translations-raw huggingface dataset:
The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy and confers high-level resistance to lamivudine.
Pri z virusom HIV-1 okuženih bolnikih, ki so se zdravili s protiretrovirusnim zdravljenjem, ki je vsebovalo lamivudin, sta se pojavili varianti M184V ali M184I, ki sta povzročili visoko stopnjo odpornosti proti lamivudinu.
The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Pri z virusom HIV-1 okuženih bolnikih, ki so se zdravili s protiretrovirusnim zdravljenjem, ki je vsebovalo lamivudin, sta se pojavili varianti M184V ali M184I.
The M184V/I mutation developed in 2/19 (10.5%) isolates analysed from patients in the efavirenz + emtricitabine + tenofovir disoproxil fumarate group and in 10/29 (34.5%) isolates analysed from the efavirenz + lamivudine/zidovudine group (p-value < 0.05, Fisher’s Exact test comparing the emtricitabine + tenofovir disoproxil fumarate group to the lamivudine/zidovudine group among all subjects).
Mutacija M184V/I se je pojavila pri 2 od 19 (10,5 %) analiziranih izolatih bolnikov v skupini, ki je prejemala efavirenz + emtricitabin + dizoproksiltenofovirijev fumarat, ter pri 10 od 29 (34,5 %) analiziranih izolatih skupine, ki je prejemala efavirenz + lamivudin/zidovudin (vrednost p < 0,05, Fisherjev test natančnosti na osnovi primerjave skupine emtricitabin+dizoproksiltenofovirijev fumarat s skupino lamivudin/zidovudin med vsemi preiskovanci).
The M3 metabolite was the predominant analyte in excreta (~17% of the dose), followed by M2’ (~11% of the dose) and M2 (~4.4 of the dose).
Kot analit v izločkih je prevladoval presnovek M3 (~17 % odmerka), presnovkov M2’ (~11 % odmerka) in M2 (~4,4 % odmerka) je bilo manj.
The M4 metabolite shows a phosphodiesterase selectivity profile similar to that of avanafil and an in vitro inhibitory potency for PDE5 18% of that of avanafil.
Presnovek M4 je podobno selektiven za fosfodiesterazo kot avanafil, njegova moč zaviranja PDE5 in vitro pa je bila 18 % moči avanafila.
The MabCampath solution must be prepared according to the instructions provided in section 6.6. All doses should be administered by intravenous infusion over approximately 2 hours.
Raztopino zdravila MabCampath je treba pripraviti po navodilih, navedenih v poglavju 6.6. Vse odmerke je treba intravensko infundirati v približno 2 urah.
The macrophages were shown to contain telavancin and
Makrofagi so vsebovali telavancin in HP–β–CD.
The macula provides central vision needed to see detail for everyday tasks such as driving, reading and recognising faces.
Makula omogoča središčni vid, ki je potreben pri izvajanju vsakdanjih opravil, na primer pri vožnji avtomobila, branju in prepoznavanju obrazov.
The macula provides central vision that is needed to see detail for everyday tasks such as driving, reading and recognising faces.
Makula zagotavlja osrednji vid, ki je potreben za zaznavanje podrobnosti med vsakdanjimi opravili, na primer pri vožnji avtomobila, branju in prepoznavanju obrazov.
The made-up medicine can be used for 2 months.
Rok uporabnosti pripravljenega zdravila je 2 meseca.
The magnitude of analgesic effect of the 40 mg dose was comparable with that of ketorolac 60 mg IM or ketorolac 30 mg IV.
Izrazitost analgetičnega učinka 40 mg odmerka je bila primerljiva tisti po 60 mg ketorolaka intramuskularno ali 30 mg ketorolaka intravensko.
The magnitude of immune response was lower in the group who received the 2nd dose 1 week later and higher in the groups with longer interval schedules.
Moč imunskega odziva je bila niţja v skupini, ki je prejela 2. odmerek 1 teden kasneje in višja v skupini z daljšimi reţimi presledkov.
The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
Izrazitost interakcije je podobna tisti opisani pri Viekirax + dasabuvir.
The magnitude of interaction when administered with medicinal products listed in Table 2 are similar (≤25% difference in the Least Square Means ratio) for Viekirax with or without dasabuvir, unless otherwise noted.
Izrazitost interakcije med uporabo z zdravili, navedenimi v preglednici 2, je podobna (≤ 25 % razlika v razmerju povprečij po metodi najmanjših kvadratov) za zdravilo Viekirax z dasabuvirjem ali brez njega, razen če je navedeno drugače.
The magnitude of median PFS effect was different in the subgroups by prior therapy.
Mediana vpliva na čas preživetja brez napredovanja bolezni se je med podskupinami razlikovala v odvisnosti od predhodnega zdravljenja.
The magnitude of the effect of moderate to strong inducers (e.g. efavirenz, rifabutin) on olaparib exposure is not established, therefore the co-administration of olaparib with these drugs is also not recommended.
Velikost učinka zmernih do močnih induktorjev (npr. efavirenza, rifabutina) na izpostavljenost olaparibu ni ugotovljena, zato sočasna uporaba olapariba s takšnimi zdravili prav tako ni priporočljiva.
The magnitude of the efficacy outcomes observed at week 24 of treatment was comparable to that observed at week 12:
Rezultati glede učinkovitosti so bili po 24 tednih podobni kot po 12 tednih zdravljenja:
The magnitude of these changes was similar to that seen in published studies, which corresponded to a 15- letter gain in Best Corrected Visual Acuity (BCVA).
Obseg teh sprememb je bil podoben kot v objavljenih študijah in ustreza pridobitvi 15 črk BCVA (najboljša korigirana ostrina vida).
The magnitude of these changes was similar to that seen in published studies, which corresponded to a 15-letter gain in Best Corrected Visual Acuity (BCVA).
Velikost teh sprememb je bila podobna tistim, o katerih so poročali v objavljenih študijah, kar ustreza pridobitvi 15 črk BCVA (Best Corrected Visual Acuity).
The magnitude of these reductions was not considered to be clinically relevant.
Obseg teh zmanjšanj ni klinično pomemben, zato pri bolnikih z blago do zmerno okvaro jeter (ocena po
The magnitude of this value, coupled with the significant decrease in the elimination of doripenem seen with concomitant probenecid administration, suggests that doripenem undergoes glomerular filtration, tubular secretion and
Velikost te vrednosti ter pomembno zmanjšanje izločanja doripenema, ki so ga opazili pri sočasni uporabi probenecida, kažeta, da se doripenem izloča z glomerulno filtracijo, s tubulno sekrecijo in se tudi reabsorbira.
The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long- term exposure (at least 24 weeks) than with short-term exposure.
Obseg povečanja telesne mase ter razmerje mladostnikov, ki so imeli klinično značilno zvečanje telesne mase, sta bila višja pri dolgoročni izpostavljenosti (najmanj 24 tednov) kot pri kratkoročni izpostavljenosti.
The magnitude of weight gain and the proprotion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Obseg povečanja telesne mase ter razmerje mladostnikov, ki so imeli klinično značilno zvečanje telesne mase, sta bila višja pri dolgoročni izpostavljenosti (najmanj 24 tednov) kot pri kratkoročni izpostavljenosti.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 03 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 03 načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.1 of the Risk Management Plan (RMP) presented in Module 1.8.2 of the Marketing Authorisation Application and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v farmakovigilančnem načrtu, dogovorjenem v različici 1.1 načrta za obvladovanje tveganja (RMP), predloženi v modulu 1.8.2 vloge za dovoljenje za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.3 of the Risk Management Plan (RMP) presented in Module of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet se zavezuje, da bo izpeljal vse študije in dodatne aktivnosti v zvezi s farmakovigilanco, navedene v načrtu farmakovigilance, kot je bilo dogovorjeno v različici 1.3 načrta obvladovanja tveganja, predloženega v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in v skladu z vsemi nadaljnjimi posodobitvami načrta za obvladovanje tveganja, odobrenimi s strani Odbora za zdravila za uporabo v humani medicini (CHMP).
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 4.0 načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
The MAH commits to present a plan for the definition of the sources to collect safety data on immunocompromised patient within the prospective cohort safety study.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo predstavil načrt za določanje virov zbiranja podatkov o varnosti pri imunokomprimitiranih bolnikih s prospektivno kohortno študijo varnosti.
The MAH commits to submit the data from pregnancy registry as described in the RMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo posredoval podatke iz svojega internega registra nosečnosti kot je zabeleženo v Načrtu za obvladovanje tveganja.
The MAH commits to update the observational study protocol to screen for auto-antibodies those patients presenting visual or ocular events during the study follow- up.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo posodabljal protokol opazovalnih študij za presejalne raziskave za oceno avtoprotiteles pri tistih bolnikih, ki so v fazi sledenja po študiji imeli težave z vidom ali očmi.
The MAH considers these events a clinical manifestation of ‘photoreceptor alteration’ events, and proposes an update to the product information.
MAH meni, da so ti dogodki klinična manifestacija dogodkov ‘alteracija fotoreceptorja’ in predlaga posodobitev informacije o zdravilu.
The MAH has previously committed to undertake a “Phase III placebo-controlled trial with celecoxib in genotype positive subjects with Familial Adenomatous Polyposis” (CHIP trial, Protocol A3191193) to generate further efficacy and safety data.
Imetnik dovoljenja za promet se je predhodno zavezal, da izvede “S placebom nadzorovano preskušanje III. faze s celekoksibom pri genotipsko pozitivnih preiskovancih s familiarno adenomatozno polipozo” (preskušanje CHIP , protokol A3191193), s katero pridobi dodatne podatke o učinkovitosti in varnosti.
The MAH has proposed addition of ‘anaphylactic reaction’ and ‘stomatitis’ to section 4.8 of the SmPC.
Imetnik dovoljenja za promet z zdravilom je predlagal, da se v poglavje 4.8 povzetka glavnih značilnosti zdravila dodata "anafilaktična reakcija" in "stomatitis".
The MAH interprets these events as a consequence of the ‘photoreceptor alteration’ events discussed below.
Imetnik dovoljenja za promet z zdravilom (MAH) razlaga te dogodke kot posledico dogodkov ‘alteracija fotoreceptorja’, o katerih razpravljamo spodaj.
The MAH is requested to provide reports on the ß-Confident registry (CACZ885D2401), which was designed to provide data on long-term safety and effectiveness of Ilaris treatment in paediatric and adult CAPS patients in routine clinical practice.
Imetnik dovoljenja za promet z zdravilom mora predložiti poročila o registru ß-Confident (CACZ885D2401), ki je namenjen zbiranju podatkov o dolgoročni varnosti in učinkovitosti zdravljenja z zdravilom Ilaris pri pediatričnih in odraslih bolnikih s CAPS v rutinski klinični praksi.
The MAH is requested to update OS status of study A8081007 and provide the final data within 9 months after the required 238 OS events have been reached.
Imetnik dovoljenja za promet z zdravilom mora posodobiti stanje OS za študijo A8081007 in predložiti končne podatke v 9 mesecih po dosegu zahtevanih 238 dogodkov OS.
The MAH is required to provide updates on the recruitment rates and any intermediary results annually within the annual re- assessment.
Imetnik dovoljenja za promet z zdravilom mora vsako leto v okviru ponovne ocene predložiti zadnje podatke o številu vključenih bolnikov in morebitne vmesne rezultate.
The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority in each Member State prior to distribution of the educational pack in their territory.
Imetnik dovoljenja za promet z zdravilom se mora pred razdeljevanjem izobraževalnega paketa v vsaki posamezni državi članici z nacionalnimi pristojnimi organi dogovoriti glede vsebine in oblike izobraževalnega gradiva ter načrta obveščanja.
The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution of the educational pack.
Imetnik dovoljenja za promet z zdravilom mora vsebino in obliko izobraževalnega gradiva ter načrt sporočanja pred distribucijo uskladiti s pristojnim nacionalnim organom.
The MAH must agree the content and format of the medical educational pack with the national competent authority in each Member State prior to its distribution in their territory.
Imetnik dovoljenja za promet z zdravilom se mora z nacionalno pristojnim organom v vsakih državi članici pred distribucijo zdravila na svojem ozemlju dogovoriti o vsebini in obliki medicinskega izobraževalnega paketa.
The MAH must agree the content and format of the Prescriber Guide together with a communication plan, with the national competent authority in each Member State prior to distribution of the educational pack in their territory.
Imetnik dovoljenja za promet z zdravilom mora vsebino in obliko navodil za predpisovanje in načrt obveščanja pred distribucijo uskladiti s pristojnim nacionalnim organom v vseh državah članicah.
The MAH must ensure that all physicians who are expected to prescribe MabThera are provided with the following:
Imetnik dovoljenja za promet mora zagotoviti, da zdravniki, ki lahko predpišejo zdravilo MabThera, prejmejo:
The MAH must ensure that at launch all physicians who are expected to prescribe Esbriet are provided with a physician information pack containing the following:
Preden da zdravilo v promet, mora imetnik dovoljenja za promet z zdravilom zagotoviti, da vsi zdravniki, ki bodo predpisovali zdravilo Esbriet, prejmejo gradivo z informacijami za zdravnike, ki vsebuje:
The MAH must ensure that the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 vloge dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, ki je predložen v modulu 1.8.1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the medicinal product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, in predložen v modulu 1.8.1 za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must ensure that the system of pharmacovigilance, as described in Part 1 of the marketing authorisation application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisano v delu 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in delujoč, preden se zdravilo da v promet in med njegovim trženjem.
The MAH must ensure that the system of pharmacovigilance, as described in Part I of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v delu I vloge za pridobitev dovoljenja za promet, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2.0, predstavljeni v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2.0 in predložen v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must ensure that the system of pharmacovigilance, as described in version 2.1 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora poskrbeti za vzpostavitev sistema farmakovigilance, kot je opisan v različici 2.1 in predstavljen v modulu 1.8.1 vloge za pridobitev dovoljenja za promet z zdravilom, ki mora biti v veljavi tako preden gre zdravilo na trg kot tudi takrat, ko je zdravilo že na trgu.
The MAH must ensure that the system of pharmacovigilance, as described in version 20 October 2009 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 20 z oktobra 2009 in predložen v modulu 1.8.1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must ensure that the system of pharmacovigilance, as described in version 5 dated 27 April 2009 presented in Module 1.8.2 of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 5 z dne 27. aprila 2009 in predložen v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must ensure that the system of Pharmacovigilance, as presented in Module 1.8.1 of the Marketing Authorisation Application, is in place and functioning before and whilst the medicinal product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 vloge za dovoljenje za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1. dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance je predstavljen v Modulu 1.8.1. pridobitve dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo na trg in toliko časa, kolikor bo zdravilo v prometu.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States
Imetnik dovoljenja za trženje mora ta izobraževalni načrt uvesti nacionalno pred začetkom trženja, in kot je dogovorjeno s pristojnimi organi države članice.