FrancophonIA/ELRC3.0 huggingface dataset:
English: If PML is confirmed, lenalidomide must be permanently discontinued.
Slovenian: Če se PML potrdi, je treba zdravljenje z lenalidomidom trajno ukiniti.
English: Cases have generally been reported in patients taking concomitant dexamethasone or prior treatment with other immunosuppressive chemotherapy.
Slovenian: O primerih so na splošno poročali pri bolnikih, ki so sočasno jemali deksametazon ali so se predhodno zdravili z drugo imunosupresivno kemoterapijo.
English: What you need to know before you take Eliquis Other medicines and Eliquis
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Eliquis Druga zdravila in zdravilo Eliquis
English: Physicians should monitor patients at regular intervals and should consider PML in the differential diagnosis in patients with new or worsening neurological symptoms, cognitive or behavioural signs or symptoms.
Slovenian: Zdravniki morajo redno spremljati bolnike in pri diferencialni diagnozi pri bolnikih z novimi ali napredujočimi nevrološkimi, kognitivnimi ali vedenjskimi znaki ali simptomi upoštevati možnost PML.
English: What you need to know before you take Lixiana/Roteas Other medicines and Lixiana/Roteas
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Lixiana/Roteas Druga zdravila in zdravilo Lixiana/Roteas
English: *Note: Stated frequencies are applicable for pegfilgrastim; for lipegfilgrastim and lenograstim the frequency is to be calculated by the MAHs.
Slovenian: * Opomba: Navedene pogostnosti veljajo za pegfilgrastim; pogostnost za lipegfilgrastim in lenograstim izračunajo imetniki dovoljenja za promet z zdravilom.
English: The evaluation for PML should be based on neurological examination, magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JC virus (JCV) DNA by polymerase chain reaction (PCR) or a brain biopsy with testing for JCV.
Slovenian: Diagnostika za PML mora temeljiti na nevrološkem pregledu, magnetnoresonančnem slikanju možganov in analizi cerebrospinalnega likvorja za DNK virusa JC (JCV) z verižno reakcijo s polimerazo (PCR) ali na biopsiji možganov s preiskavo za JCV.
English: Additional follow-up and evaluation may be warranted if no alternative diagnosis can be established.
Slovenian: Če ni mogoče postaviti druge diagnoze, sta lahko potrebna dodatno spremljanje in diagnostika.
English: Lenalidomide - Progressive multifocal leukoencephalopathy (PML) (EPITT no 19130)
Slovenian: Lenalidomid - Progresivna multifokalna levkoencefalopatija (PML) (EPITT št. 19130)
English: Lenograstim; lipegfilgrastim; pegfilgrastim - Pulmonary haemorrhage (EPITT no 19181)
Slovenian: Lenograstim; lipegfilgrastim; pegfilgrastim - Krvavitev v pljučih (EPITT št. 19181)
English: If PML is suspected, further dosing must be suspended until PML has been excluded.
Slovenian: Pri sumu na PML je treba nadaljnje odmerke začasno ustaviti do izključitve PML.
English: Special warnings and precautions for use Interaction with other medicinal products affecting haemostasis
Slovenian: Posebna opozorila in previdnostni ukrepi Medsebojno delovanje z drugimi zdravili, ki vplivajo na hemostazo
English: • anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid (aspirin))
Slovenian: • protivnetna zdravila in zdravila za lajšanje bolečin (npr. naproksen ali acetilsalicilno kislino (aspirin))
English: What you need to know before you use REVLIMID [...]
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo REVLIMID [...] Opozorila in previdnostni ukrepi
English: Despite these findings, there may be individuals with a more pronounced pharmacodynamic response when antiplatelet agents are coadministered with apixaban.
Slovenian: Kljub tem ugotovitvam pa je pri posameznih bolnikih lahko farmakodinamični odziv pri sočasni uporabi antitrombocitnih učinkovin in apiksabana izrazitejši.
English: Anticoagulants, antiplatelets, and thrombolytics Interaction with other medicinal products affecting haemostasis
Slovenian: Antikoagulanti, antiagregacijska zdravila in trombolitiki Medsebojno delovanje z drugimi zdravili, ki vplivajo na hemostazo
English: Undesirable effects Nervous system disorders Frequency ‘rare': meningitis (aseptic)
Slovenian: Pogostnost „redki“: meningitis (aseptični)
English: Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported with lenalidomide.
Slovenian: Pri zdravljenju z lenalidomidom so poročali o primerih progresivne multifokalne levkoencefalopatije (PML), tudi s smrtnim izidom.
English: Inflammation of the membrane around the spinal cord and brain, which may present as neck stiffness, headache, fever, eye sensitivity to light, nausea and vomiting (meningitis)
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1 000 bolnikov) Vnetje ovojnice hrbtenjače in možganov, ki se lahko kaže kot otrdelost vratu, glavobol, vročina, preobčutljivost oči na svetlobo, slabost in bruhanje (meningitis).
English: Apixaban; edoxaban - Drug interaction between apixaban or edoxaban and selective serotonin reuptake inhibitors (SSRI) and/or serotonin and noradrenaline reuptake inhibitors (SNRI) leading to increased risk of bleeding (EPITT no 19139)
Slovenian: Apiksaban; edoksaban - Medsebojno delovanje med apiksabanom ali edoksabanom ter selektivnimi zaviralci privzema serotonina (SSRI) in/ali zaviralci privzema serotonina in noradrenalina (SNRI), ki povzroči povečano tveganje za pojav krvavitve (EPITT št. 19139)
English: - medicines for high blood pressure or heart problems (e.g., diltiazem) - antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin
Slovenian: - zdravila za zdravljenje visokega krvnega tlaka ali težav s srcem (npr. diltiazem) - antidepresivi, imenovani selektivni zaviralci privzema serotonina ali zaviralci privzema serotonina in noradrenalina
English: At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Slovenian: Če se kadar koli med zdravljenjem ali po njem pojavi kaj od naslednjega, o tem takoj obvestite zdravnika ali medicinsko sestro: zamegljen vid, izguba vida ali dvojni vid, težave pri govorjenju,
English: Eliquis should be used with caution when coadministered with SSRIs/SNRIs or NSAIDs (including acetylsalicylic acid) because these medicinal products typically increase the bleeding risk.
Slovenian: Pri sočasni uporabi zdravila Eliquis in SSRI/SNRI ali NSAID nesteroidnih protivnetnih zdravil (vključno z acetilsalicilno kislino) je potrebna previdnost, saj je za ta zdravila značilno, da povečajo tveganje za krvavitve.
English: These include acetylsalicylic acid (ASA), P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), and chronic nonsteroidal anti-inflammatory drugs (NSAIDs) (see section 4.5).
Slovenian: Ta zdravila vključujejo acetilsalicilno kislino (ASA), inhibitorje trombocitov P2Y12, druge antitrombotike, fibrinolitično terapijo, selektivne zaviralce privzema serotonina (SSRI) ali zaviralce privzema serotonina in noradrenalina (SNRI) in kronična nesteroidna protivnetna zdravila (NSAID)(glejte poglavje 4.5).
English: Care is to be taken if patients are treated concomitantly with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs), or non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid.
Slovenian: Previdnost je potrebna, kadar se bolniki sočasno zdravijo s selektivnimi zaviralci privzema serotonina (SSRI) ali zaviralci privzema serotonina in noradrenalina (SNRI) ali z nesteroidnimi protivnetnimi zdravili (NSAID), vključno z acetilsalicilno kislino.
English: • antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin
Slovenian: • antidepresive, imenovane selektivni zaviralci privzema serotonina ali zaviralci privzema serotonina in noradrenalina
English: A significant increase in bleeding risk was reported with the triple combination of apixaban, ASA and clopidogrel in a clinical study in patients with acute coronary syndrome (see section 4.4).
Slovenian: V klinični študiji so pri bolnikihz akutnim koronarnim sindromom pri sočasni uporabi apiksabana, acetilsalicilne kisline in klopidogrela poročali o pomembnem povečanju tveganja za pojav krvavitev (glejte poglavje 4.4).
English: Apixaban
Slovenian: Apiksaban
English: Edoxaban
Slovenian: Edoksaban
English: Coughing up blood (haemoptysis) - uncommon* Bleeding from the lung (pulmonary haemorrhage) - rare*
Slovenian: Možni neželeni učinki (na podlagi ustrezajoče pogostnosti): izkašljevanje krvi (hemoptiza) - občasni* krvavitev iz pljuč (pljučna hemoragija) - redki*
English: Undesirable effects Respiratory, thoracic and mediastinal disorders Haemoptysis (uncommon*) Pulmonary haemorrhage (rare*)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Hemoptiza (občasni*)
English: Interaction with other medicinal products and other forms of interaction Anticoagulants, platelet aggregation inhibitors, SSRIs/SNRIs and NSAIDs
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Antikoagulanti, zaviralci agregacije trombocitov, selektivni zaviralci privzema serotonina (SSRI)/zaviralci privzema serotonina in noradrenalina (SNRI) in nesteroidna protivnetna zdravila (NSAID)
English: Interaction with other medicinal products and other forms of interaction Anticoagulants, antiplatelets, and NSAIDs and SSRIs/SNRIs
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Antikoagulanti, antitrombotiki,in nesteroidna protivnetna zdravila (NSAID) ter selektivni zaviralci privzema serotonina (SSRI)/zaviralci privzema serotonina in noradrenalina (SNRI)
English: Warnings and precautions
Slovenian: Bolezni živčevja
English: The current fee system consists of around 130 different fees.
Slovenian: Sedanji sistem pristojbin vključuje približno 130 različnih pristojbin.
English: Transparency is the key aspects of the new proposals.
Slovenian: Preglednost je ključni vidik novih predlogov.
English: A separate discussion with the ECDC will be organised.
Slovenian: Organizirana bo ločena razprava s centrom ECDC.
English: As a consequence, resources needed to respond to a single request are currently disproportionate.
Slovenian: Zato so viri, ki so potrebni za odgovor na posamezen zahtevek, zdaj nesorazmerni.
English: The European Commission study estimates that 5-7 full time equivalents will be needed for this task.
Slovenian: V študiji Evropske komisije je bilo ocenjeno, da bo za to nalogo potrebnih 5-7 ekvivalentov polnega delovnega časa.
English: The second meeting of the chairs took place on 31 May 2010.
Slovenian: Drugi sestanek predsednikov je potekal 31. maja 2010.
English: The first report is expected at the beginning of 2011.
Slovenian: Pričakuje se, da bo prvo poročilo pripravljeno na začetku leta 2011.
English: Common systems need to be developed for proactive release of information.
Slovenian: Oblikovati je treba skupne sisteme za proaktivno objavo informacij.
English: Ombudsman and access to EMA documents
Slovenian: Varuh človekovih pravic in dostop do dokumentov agencije EMA
English: Alternates and other participants
Slovenian: Nadomestni člani in drugi udeleženci
English: The dates for 2011 are as follows: 16-17 March, 9 June, 6 October and 15 December.
Slovenian: Datumi za leto 2011 so: 16. in 17. marec, 9. junij, 6. oktober in 15. december.
English: The whole report can be found on the website of the Commission: http://ec.europa.eu/health/files/pharmacos/news/emea_final_report_vfrev2.pdf
Slovenian: Celotno poročilo je na voljo na spletni strani Komisije na naslovu: http://ec.europa.eu/health/files/pharmacos/news/emea_final_report_vfrev2.pdf.
English: The lease of the Agency's premises expiries in 2014.
Slovenian: Najem prostorov agencije se bo iztekel leta 2014.
English: Contractual arrangements: monitoring of key performance indicators
Slovenian: Pogodbene ureditve: spremljanje ključnih kazalnikov uspešnosti
English: Currently, the Agency uses teleconferencing for meetings involving small numbers of participants.
Slovenian: Agencija zdaj uporablja telekonference za sestanke z manjšim številom udeležencev.
English: European Commission initiative on vigilance system for substances of human origin: cells, tissues, blood
Slovenian: Pobuda Evropske komisije o sistemu stalnega nadzora za snovi človeškega izvora: celice, tkiva in kri
English: In total there were 32 votes cast.
Slovenian: Oddanih je bilo skupaj 32 glasov.
English: The experience was largely welcomed by the committee Chair and members.
Slovenian: Predsednik in člani odbora so to izkušnjo večinoma pozdravili.
English: The proposals coming from the discussions will be classified into those requiring legislative changes and those that can be implemented without changing the legislation.
Slovenian: Predlogi iz razprav bodo razvrščeni med predloge, ki zahtevajo zakonodajne spremembe, in predloge, ki jih je mogoče izvajati brez spremembe zakonodaje.
English: Activities related to referrals increased since the 2004 review of legislation.
Slovenian: Količina dejavnosti v zvezi z napotitvami se je od pregleda zakonodaje iz leta 2004 povečala.
English: 4 August 2010 EMA/MB/404038/2010
Slovenian: 4. avgust 2010 EMA/MB/404038/2010
English: • The political agreement on cross-border healthcare directive.
Slovenian: • političnim sporazumom o direktivi o čezmejnem zdravstvenem varstvu;
English: New appointments
Slovenian: Nova imenovanja
English: Amongst other measures to increase transparency, all declarations of interests submitted by the experts will be systematically published on the website.
Slovenian: V okviru drugih ukrepov za izboljšanje preglednosti bodo na spletni strani sistematično objavljene vse izjave o interesih, ki jih predložijo strokovnjaki.
English: The system is complex and therefore requires simplification, while assuring sustainability and providing needed flexibility.
Slovenian: Ker je zapleten, ga je treba poenostaviti, obenem pa zagotoviti trajnost in potrebno prožnost.
English: This item was considered at the beginning of the meeting by the Vice-Chair.
Slovenian: Podpredsednica je to točko obravnavala na začetku seje.
English: The procedure for the appointment of the Executive Director will be discussed in October.
Slovenian: O postopku imenovanja izvršnega direktorja se bo razpravljalo oktobra.
English: Declaration of conflict of interests
Slovenian: Izjava o navzkrižju interesov
English: No conflicts of interests were declared.
Slovenian: Nihče ni izrazil navzkrižja interesov.
English: Observers from Liechtenstein and Norway were appointed as tellers.
Slovenian: Opazovalca iz Lihtenštajna in Norveške sta bila imenovana za preštevalca glasov.
English: The decision on the option may need to be taken this year to allow adequate time to involve relevant EU institutions and to prepare the Agency for changes, if necessary.
Slovenian: Odločitev o najprimernejši možnosti bo morda treba sprejeti še letos, da bo na voljo dovolj časa za vključitev ustreznih institucij EU in da se bo po potrebi agencija pripravila na spremembe.
English: • Progress on legislative proposals on pharmacovigilance, falsified medicines and information to patients.
Slovenian: • napredkom pri zakonodajnih predlogih o farmakovigilanci, ponarejenih zdravilih in informacijah za bolnike;
English: A new legislative proposal may be adopted by Autumn 2011.
Slovenian: Nov zakonodajni predlog bo morda sprejet do jeseni 2011.
English: Key principles of a revised policy and procedure for the handling of conflicts of interest
Slovenian: Ključna načela revidirane politike in postopek za obravnavo navzkrižja interesov
English: The Board recognised that the arrangements on handing of conflicts of interest differ in different Member States and this needs to be reflected in the memorandum.
Slovenian: Priznal je, da se ureditve za obravnavo navzkrižij interesov po državah članicah razlikujejo in da je na to treba opozoriti v memorandumu.
English: The Management Board telematics committee will prepare an overview of available options.
Slovenian: Odbor upravnega odbora za telematiko bo pripravil pregled razpoložljivih možnosti.
English: In case an Executive Director cannot be appointed by the end of 2010 or is unable to start office from 1 January 2011, the Board asked the Executive Director to inform the Board about the arrangements to appoint an interim director for discussion at the October meeting.
Slovenian: Če izvršnega direktorja ne bo mogoče imenovati do konca leta 2010 ali če ta ne bo mogel nastopiti mandata 1. januarja 2011, je upravni odbor pozval izvršnega direktorja, naj ga obvesti o ureditvi za imenovanje začasnega direktorja, o kateri se bo razpravljalo na oktobrski seji.
English: The Board was advised of the list of scientific, international and national publications in which the announcement is to be placed.
Slovenian: Upravni odbor je prejel nasvete o seznamu znanstvenih, mednarodnih in nacionalnih publikacij, v katerih je treba objaviti obvestilo.
English: Following this, the Council will give its advice on whether the Fee Regulation needs to be reviewed.
Slovenian: Svet bo zatem svetoval, ali je treba uredbo pregledati.
English: Providing such access demands significant resources for the Agency.
Slovenian: Agencija za zagotavljanje takega dostopa potrebuje precejšnje vire.
English: The number of indictors will be expanded in future, once experience with the agreed indicators is gained and systems for reporting on other indicators are established.
Slovenian: Število kazalnikov se bo v prihodnosti povečalo po prvih izkušnjah z dogovorjenimi kazalniki in vzpostavitvi sistemov poročanja o drugih kazalnikih.
English: Draft agenda for 10 June 2010 meeting
Slovenian: Osnutek dnevnega reda za sejo dne 10. junija 2010
English: Following the adoption, the Board's opinion and the final accounts will be sent to the relevant EU institutions.
Slovenian: Ko bodo mnenje upravnega odbora in končni računovodski izkazi sprejeti, bodo poslani ustreznim institucijam EU.
English: However, an agreement on what information should be considered confidential is pending.
Slovenian: Vendar še vedno ni bil dosežen sporazum, katere informacije je treba šteti za zaupne.
English: A workshop will be organised on 6-7 September 2010 as part of the consultation process, to which a wide range of EU and third-country regulators and stakeholders will be invited.
Slovenian: V okviru posvetovanja bo 6. in 7. septembra 2010 organizirana delavnica, na katero bodo povabljeni številni regulativni organi in zainteresirane strani iz EU in tretjih držav.
English: However, the European Commission representative stated that the Commission will be unable to allocate additional resources and the tasks will have to be accommodated within the existing human and financial resources at either Agency.
Slovenian: Vendar je predstavnik Evropske komisije povedal, da Komisija ne more dodeliti dodatnih virov in da bo treba naloge opraviti z obstoječimi človeškimi in finančnimi viri teh dveh agencij.
English: The Board also asked the European Commission to assure timely communication with the Board at the highest level.
Slovenian: Upravni odbor je poleg tega Evropsko komisijo pozval, naj poskrbi za pravočasno komuniciranje z upravnim odborom na najvišji ravni.
English: 7. Review of fees payable to the EMA (Fee Regulation)
Slovenian: Pregled pristojbin, ki se plačujejo agenciji EMA (uredba o pristojbinah)
English: The number of data fields to be removed varies in different cases.
Slovenian: Število podatkovnih polj, ki jih je treba odstraniti, se po posameznih primerih razlikuje.
English: Apologies
Slovenian: Opravičilo
English: The Board also considered the analysis of the impact of proposed changes on the current membership of the committees and scientific advisory groups.
Slovenian: Poleg tega je obravnaval analizo učinka predlaganih sprememb na sedanje članstvo v odborih in znanstvenih svetovalnih skupinah.
English: The conclusions of the evaluation are positive and highlight the effectiveness and the efficiency of the Agency, as part of the network, as well as recognising its contribution to EU policies.
Slovenian: Sklepne ugotovitve ocene so pozitivne ter poudarjajo učinkovitost in uspešnost agencije kot dela mreže, poleg tega pa je v njih priznan tudi njen prispevek k politikam EU.
English: • A strategic discussion on the benefits of e-readiness and the different systems being used by medicines agencies to work in an electronic-only environment.
Slovenian: • strateško razpravo o koristih e-pripravljenosti in različnih sistemih, ki jih agencije za zdravila uporabljajo pri delu v izključno elektronskem okolju;
English: The report contains information for 2009 on what action has been taken by the rapporteur and the regulatory outcome, where relevant.
Slovenian: Poročilo vsebuje informacije za leto 2009 o ukrepih, ki jih je sprejel poročevalec, in njihovem zakonodajnem učinku, če je to primerno.
English: • Overview of the allowable conflicts of interests for the various EMA activities.
Slovenian: • Pregled dovoljenih navzkrižij interesov za različne dejavnosti agencije EMA.
English: When deciding where to allocate the responsibilities for the new task, the European Commission may consider whether to combine the capacities and experience of collaboration of the two agencies (EMA and ECDC).
Slovenian: Evropska komisija lahko med odločanjem, komu naj podeli pristojnosti za to novo nalogo, prouči, ali naj združi zmogljivosti in izkušnje s sodelovanjem dveh agencij (EMA in ECDC).
English: 32 votes cast
Slovenian: 32 oddanih glasov
English: The Agency works to address the issues and will adopt the same approach to data released reactively and proactively.
Slovenian: Agencija si prizadeva obravnavati ta vprašanja in bo sprejela en sam pristop za podatke, ki so objavljeni reaktivno in proaktivno.
English: The Executive Director's report covers the achievements in key policy areas as well as describes the management system to provide reasonable assurance on the effective and efficient use of resources to achieve the policy objectives.
Slovenian: Poročilo izvršnega direktorja zajema dosežke na ključnih področjih politike in opis sistema upravljanja za predložitev razumnega zagotovila o učinkoviti in smotrni uporabi virov za doseganje ciljev politike.
English: • Presentation on key principles of a revised policy and procedures on the handling of conflicts of interests of scientific committees' members and experts: Impact analysis and proposed way forward.
Slovenian: • Predstavitev ključnih načel revidirane politike in postopkov za obravnavo navzkrižij interesov članov in strokovnjakov znanstvenih odborov: analiza učinka in predlagani prihodnji ukrepi.
English: The final adoption of an updated policy is expected in October 2010.
Slovenian: Končno sprejetje posodobljene politike je načrtovano za oktober 2010.
English: The proposals will be implemented in a stepwise approach.
Slovenian: Predlogi se bodo izvajali postopoma.
English: The Agency started work to identify and review options for future accommodation taking into account financial and functional requirements, including accessibility of the Agency by experts.
Slovenian: Agencija je začela izvajati dejavnosti za opredelitev in proučitev možnosti za prihodnje prostore ob upoštevanju finančnih in funkcionalnih zahtev, vključno z dostopnostjo agencije za strokovnjake.
English: Tabled documents
Slovenian: Predloženi dokumenti
English: The activity of the newly proposed member in his capacity of a surgeon is only very marginally linked with the objectives of the CHMP.
Slovenian: Dejavnost novega predlaganega člana v funkciji kirurga je le zelo bežno povezana s cilji odbora CHMP.
English: The newly proposed member never worked as a member of the CHMP and has no specific experience as an employee at the National Medicines Agency.
Slovenian: Predlagani član ni bil nikoli član odbora CHMP in nima izkušenj z delom v nacionalni agenciji za zdravila.