FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment should not be started or should be stopped in patients with abnormal liver enzyme levels in the blood (more than three times the normal level).
Slovenian: Pri bolnikih z nenormalno količino jetrnih encimov v krvi (za več kot trikratne običajne vrednosti) se zdravljenje ne sme začeti ali se mora prekiniti.
English: Annually, we also conduct a strategic risk-management review.
Slovenian: Vsako leto izvedemo tudi strateški pregled upravljanja tveganj.
English: The business environment and priorities for 2013
Slovenian: Poslovno okolje in prednostne naloge za leto 2013
English: The budget for 2013 does show an increase compared to 2012, but this is mainly due to fees being increased in line with inflation.
Slovenian: Proračun za leto 2013 je v primerjavi z letom 2012 večji, čeprav je to predvsem posledica pristojbin, ki so se zaradi inflacije povišale.
English: At the same time, the Agency needs to find compensation for services that do not generate revenue (of which there have been an increasing number in recent years) and to finance new legislative tasks.
Slovenian: Hkrati mora agencija najti sredstva za kritje storitev, ki ne ustvarjajo prihodkov (teh je v zadnjih letih čedalje več), in za financiranje novih projektov v zvezi z zakonodajo.
English: Increasing the efficiency of operations
Slovenian: Povečevanje učinkovitosti dejavnosti
English: Guido Rasi
Slovenian: Izvršni direktor Guido Rossi
English: Taking into account the strategy of the Agency and the analysis of its current business environment, we will focus on the following priority areas in 2013:
Slovenian: V letu 2013 se bomo ob upoštevanju strategije agencije in analize trenutnega poslovnega okolja se osredotočili na naslednje prednostne naloge:
English: EMA/MB/945561/2011 Executive Director
Slovenian: 11 marec 2013 EMA/154461/2013 Direktorat
English: Improvements that would further contribute to the quality of the work carried out will be made.
Slovenian: Uvedene bodo tudi izboljšave, ki bodo še dodatno pripomogle k izboljšanju kakovosti opravljenega dela.
English: Numerous detailed aspects will be discussed and agreed with national authorities to facilitate a harmonised implementation.
Slovenian: O številnih podrobnih vidikih se bo treba pogovoriti in sporazumeti z nacionalnimi organi, kar bo olajšalo usklajeno izvajanje zakonodaje.
English: A number of provisions are yet to be implemented, in cooperation with national authorities, and depend on whether resources can be made available.
Slovenian: Nekatere ukrepe je v sodelovanju z nacionalnimi organi še treba izvesti, odvisni pa so od sredstev, ki bodo na voljo.
English: We have analysed the business environment in 2012 and concluded that the factors identified in the strategy remain valid.
Slovenian: Analizirali smo poslovno okolje v letu 2012 in ugotovili, da so opredeljeni dejavniki ostali nespremenjeni.
English: These are brought together within the Operational Excellence programme.
Slovenian: Zbrane so v programu o operativni odličnosti.
English: Implementation work will continue in 2013.
Slovenian: V letu 2013 se bo tako nadaljevalo delo v zvezi z njenim izvajanjem.
English: The Agency and national competent authorities will work on topics such as the development of the Union database, assisting the European Commission in developing further implementing acts, and preparing guidance on behalf of the European Commission.
Slovenian: Agencija in nacionalni pristojni organi se bodo lotili zadev, kot so razvoj podatkovne zbirke Unije, pomoč Evropski komisiji pri pripravi nadaljnjih izvedbenih aktov in priprava smernic v imenu Evropske komisije.
English: Communication and transparency
Slovenian: Obveščanje, sporočanje in preglednost
English: Scientific-assessment activities
Slovenian: Dejavnosti znanstvenega vrednotenja
English: 1 'Road map to 2015: The European Medicines Agency's contribution to science, medicines and health'.
Slovenian: Strateški načrt do 2015: Prispevek Evropske agencije za zdravila k znanosti, zdravilom in zdravju.
English: It builds on existing processes and structures for pharmacovigilance, such as the EudraVigilance system for monitoring suspected side effects.
Slovenian: Temelji na obstoječih farmakovigilančnih postopkih in sistemih, kot je na primer sistem EudraVigilance za spremljanje domnevnih neželenih učinkov.
English: To support these priorities, we will also focus on contributing towards successful collaboration within the European medicines regulatory network, and will run a number of projects and initiatives aimed at increasing the effectiveness and efficiency of our operations.
Slovenian: V podporo tem prednostnim nalogam se bomo še bolj potrudili prispevati k uspešnemu sodelovanju znotraj evropske regulativne mreže za zdravila ter izvedli več projektov in pobud, katerih namen bo povečati učinkovitost izvajanja naših dejavnosti.
English: Subject to the outcome of the impact assessment, the European Commission plans to submit a legal proposal in the first half of 2013 that will represent a major revision of the legal framework for the authorisation of veterinary medicines.
Slovenian: Evropska komisija v prvi polovici leta 2013 glede na izid ocene učinka načrtuje predložitev zakonodajnega predloga, ki bo odraz obsežne revizije pravnega okvira za odobritev zdravil za uporabo v veterinarski medicini.
English: • Continuing to ensure that assessment activities are conducted to the highest levels of quality and of regulatory and scientific consistency.
Slovenian: • še naprej bomo zagotavljali, da bodo dejavnosti vrednotenja zdravil ustrezale najvišjim standardom kakovosti ter regulativne in znanstvene doslednosti;
English: The intention is ambitious, with the major drivers being to reduce the administrative burden for marketing-authorisation holders, to promote a genuine single market in veterinary medicines across the EU, thereby increasing availability, and to provide a more robust set of tools for managing risks associated with the use of veterinary antimicrobials.
Slovenian: Cilj je ambiciozen, glavna gonila pa so zmanjšanje upravnega bremena za imetnike dovoljenj za promet z zdravilom, spodbujanje resničnega enotnega trga zdravil za uporabo v veterinarski medicini po vsej EU, kar bo povečalo razpoložljivost ter zagotavljanje trdnejšega sklopa orodij za upravljanje tveganj, povezanih z uporabo protimikrobnih zdravil za uporabo v veterinarski medicini.
English: Following this year's exercise, we concluded that the key risks to achieving the mission of the Agency lie within areas that may impact on the quality of the scientific-assessment and pharmacovigilance activities, the availability of scientific expertise and the quality of data received by the Agency.
Slovenian: Po opravljenem letošnjem pregledu smo ugotovili, da je treba ključna tveganja, ki ogrožajo izvedbo glavnih nalog agencije, iskati na področjih, ki lahko vplivajo na kakovost znanstvenega vrednotenja zdravil in dejavnosti farmakovigilance, razpoložljivost strokovnega znanja in kakovost podatkov, ki jih agencija prejme.
English: A number of underlying initiatives are taking place that aim to increase the support to the scientific committees and to further assure the quality and consistency of the Agency's scientific outputs.
Slovenian: Trenutno poteka nekaj dodatnih pobud, katerih cilj je pomoč znanstvenim odborom in nadaljnjemu zagotavljanju kakovosti in doslednosti pripravi znanstvenih poročil agencije.
English: The legislation aims to promote and protect public health by strengthening the Europe-wide system for monitoring the safety and benefit-risk balance of medicines.
Slovenian: Cilj te zakonodaje sta promocija in varovanje javnega zdravja z izboljševanjem vseevropskega sistema za spremljanje varnosti ter razmerij med koristmi in tveganji zdravil.
English: These tasks are not without challenges in the difficult economic climate that both the Agency and the national authorities find themselves.
Slovenian: Te naloge spremljajo izzivi, povezani z gospodarskimi razmerami, v katerih delujejo agencija in nacionalni organi.
English: This sharing of information and knowledge will benefit the scientific community and various bodies working in the field of medicines (e.g. health-technology-assessment bodies).
Slovenian: Izmenjava informacij in znanja bo koristila strokovni skupnosti in drugim organom, ki delujejo na področju zdravil (npr. organov za ocenjevanje zdravstvenih tehnologij).
English: We will continue our review of how committee activities are coordinated, making certain that this results in effective interactions and a smooth, timely and complete flow of information.
Slovenian: Še naprej bomo preverjali, kako usklajeno je delovanje odborov, predvsem da bi zagotovili, da je njihovo medsebojno delovanje učinkovito, pretok informacij pa nemoten, pravočasen in popoln.
English: We will further refine our understanding of what stakeholders expect from our websites, which will help us to fine-tune the next stages of our project to bring together our separate websites into one corporate website, and to progress the development of the European medicines web portal.
Slovenian: Še bolj se bomo potrudili razumeti, kakšna pričakovanja imajo naše interesne skupine glede spletnih strani, kar nam bo pomagalo pri nadaljnjih korakih v projektu združevanja ločenih spletnih strani v eno samo skupno spletišče in pri napredku razvoja evropskega zdravstvenega spletnega portala.
English: It is our objective to explain better how decisions are made with respect to all our opinions, and to provide more quantitative data in documents accompanying our opinions, where this helps to promote understanding.
Slovenian: Naš cilj je bolje pojasniti, kako se z upoštevanjem vseh naših izdanih mnenj sprejemajo odločitve, v dokumentih, ki spremljajo naša mnenja pa zagotoviti več kvantitativnih podatkov, predvsem kadar to prispeva k njihovemu boljšemu razumevanju.
English: The establishment of the Pharmacovigilance Risk Assessment Committee and the possibility of divergent opinions among the Agency committees further put in the spotlight the complex interactions among committees that the Agency needs to manage.
Slovenian: Ustanovitev Odbora za oceno tveganja na področju farmakovigilance in možnost, da se mnenja med odbori razlikujejo, sta še bolj osvetlila zapleteni vidik medsebojnega delovanja odborov, ki so pod okriljem agencije.
English: • Continuing to prepare for the implementation of the falsified-medicines legislation.
Slovenian: • nadaljevali bomo priprave na izvajanje zakonodaje o ponarejenih zdravilih;
English: As a parallel and related activity, we will implement a new ICT strategy, the key elements of which include reviewing the data architecture, streamlining the ICT-application portfolio, and assuring the best use of ICT to support the optimised processes of the Agency.
Slovenian: Vzporedna in povezana dejavnost je izvajanje nove strategije na področju IKT, katere bistveni elementi so revizija arhitekture podatkov, racionalizacija portfelja aplikacij IKT in zagotavljanje njihove najboljše uporabe v podporo čim učinkovitejšim postopkom, ki jih izvaja agencija
English: Following our successful workshop in November 2012, we will continue our planned procedure for consultation with stakeholders, to be in a position to publish the Agency's policy on the release of data from clinical trials in the latter part of the year.
Slovenian: Na podlagi uspešno izvedene delavnice novembra 2012 bomo nadaljevali načrtovan postopek za posvetovanje z interesnimi skupinami, da bomo lahko proti koncu leta objavili, kakšna je politika agencije glede objavljanja rezultatov kliničnih preskušanj.
English: • Preparing for the outcome of the European Commission's impact assessment on revision of the veterinary-medicines legislation.
Slovenian: • pripravili se bomo na izid ocene učinka Evropske komisije o reviziji zakonodaje o zdravilih za uporabo v veterinarski medicini;
English: In its 'Road map to 2015'1 strategy document, the European Medicines Agency (the Agency) identified a number of business drivers that impact on our choice of priorities and objectives, including advances in science, globalisation, demand for better communication and greater openness.
Slovenian: Evropska agencija za zdravila (v nadaljevanju: agencija) je v svojem strateškem dokumentu, ki vsebuje časovni načrt do leta 2015 , opredelila več poslovnih dejavnikov, ki vplivajo na izbiro prednostnih nalog in ciljev, vključujoč znanstveni napredek, globalizacijo, zahtevo po boljši komunikaciji in večjo odprtost.
English: In light of these economic trends, we are running numerous initiatives aimed at optimising the use of resources, which will increase the effectiveness of our work in the related domains.
Slovenian: Upoštevajoč gospodarska gibanja preskušamo številne pobude, da bi čim bolj izrabili razpoložljiva sredstva, s čimer se bo izboljšala učinkovitost našega dela na povezanih področjih.
English: • Further developing the communication and transparency activities of the Agency.
Slovenian: • še naprej bomo razvijali dejavnosti agencije glede obveščanja, sporočanja in preglednosti..
English: The falsified-medicines legislation
Slovenian: Zakonodaja o ponarejenih zdravilih
English: For the veterinary sector of the Agency, 2013 will therefore be a busy year, planning for change and providing assistance to the European Commission in its fields of expertise.
Slovenian: Leto 2013 bo tako za Oddelek za zdravila za uporabo v veterinarski medicini pri agenciji zelo delavno, saj bo načrtoval spremembe in Evropski komisiji pomagal na svojem področju strokovnosti.
English: We will continue to foster our approach to communication and transparency, to strengthen public confidence in the Agency and in the EU system for the evaluation and supervision of medicines.
Slovenian: Še naprej bomo utrjevali pristop, ki smo ga zavzeli v zvezi s sporočanjem, obveščanjem in preglednostjo, saj želimo utrditi zaupanje javnosti v agencijo ter v sistem EU za vrednotenje in nadzor zdravil.
English: To this end, we will further integrate new benefit-risk methodologies in our assessment work in the area of human medicines, and will use the data to communicate with the public about the benefits and risks of medicines, and about the rationale for the opinions we adopt.
Slovenian: S tem namenom bomo dejavnosti vrednotenja še bolj dopolnili z novimi metodologijami za določitev razmerij med koristmi in tveganji zdravil za uporabo v humani medicini , podatke pa bomo uporabili za obveščanje javnosti glede njihovih koristi in tveganj, pa tudi glede podlage za mnenja, ki jih sprejmemo.
English: These include the continuing implementation of the conflicts-of-interests policies and their monitoring, reviewing how the underlying assessment processes are functioning, and reviewing
Slovenian: Med njimi so nadaljnje izvajanje politik glede navzkrižja interesov in njihovega spremljanja, pregledovanje delovanja z njim povezanih postopkov vrednotenja in preverjanje, kako se obdelujejo podatki, potrebni za učinkovito vrednotenje.
English: The projects mentioned in the priority areas below aim at mitigating those risks, as do a number of activities in the work programme.
Slovenian: Projekti, ki jih omenjam v nadaljevanju na posameznih prednostnih področjih, in številne dejavnosti v delovnem programu so namenjeni ravno zmanjševanju teh tveganj.
English: Our priorities for the implementation remain as follows: activities contributing to public health are the highest priority, followed by activities that increase transparency and improve communication, followed by activities that simplify processes.
Slovenian: Pri izvajanju v ospredje še vedno postavljamo dejavnosti, ki prispevajo k javnemu zdravju, čemur sledijo dejavnosti, ki povečujejo preglednost ter izboljšujejo naš pristop k sporočanju in obveščanju, nato pa dejavnosti, katerih namen je poenostavljanje postopkov.
English: Revision of the veterinary-medicines legislation
Slovenian: Revizija zakonodaje o zdravilih za uporabo v veterinarski medicini
English: Similarly, we will advance our goal of opening the Agency's rich repository of data, information and knowledge and providing these resources to broader audiences, to benefit drug development and improve patient care.
Slovenian: Podobno si bomo še naprej prizadevali, da bi svoje bogate zbirke podatkov, informacij in znanja, ki jih hrani agencija, dali na voljo širši javnosti in tako pripomogli k razvoju zdravil in boljši zdravstveni oskrbi bolnikov.
English: The pharmacovigilance legislation
Slovenian: Zakonodaja o farmakovigilanci
English: We will continue to implement the Agency's online strategy, as part of our overall communications strategy.
Slovenian: Kot del splošne strategije obveščanja in sporočanja bomo še naprej izvajali strategijo, ki jo agencija uporablja v zvezi s svetovnim spletom.
English: The legislation enters into force in January 2013.
Slovenian: Zakonodaja bo začela veljati januarja 2013, v zvezi z njo pa mora agencija doseči kar nekaj mejnikov.
English: Further risks relate to the fact that manufacturing and clinical trials are carried out outside of the European Union (EU).
Slovenian: Nadaljnja tveganja so povezana z dejstvom, da izdelovanje zdravil in klinična
English: Continuing to ensure that assessment activities are conducted to the highest scientific levels is the main focus of the Agency.
Slovenian: Glavno vodilo agencije je zagotavljati, da so dejavnosti vrednotenja zdravil izvedene na najvišji znanstveni ravni.
English: Work programme
Slovenian: Uvod k delovnemu programu za leto 2013
English: Some of them, such as advances in science, have a longer-term effect, while others have an immediate impact, including stakeholders' expectations for greater communication, openness and transparency, the impact of new legislation and the impact of the economic climate on resources.
Slovenian: Med temi so med drugim pričakovanja interesnih skupin glede boljšega sporočanja in obveščanja, odprtosti in preglednosti, vpliva nove zakonodaje in posledic gospodarskega stanja na sredstva.
English: • Continuing to prepare for the implementation of the pharmacovigilance legislation, depending on resources.
Slovenian: • v skladu z razpoložljivimi sredstvi bomo nadaljevali priprave na izvajanje zakonodaje o farmakovigilanci;
English: Scientific opinions for non-EU markets
Slovenian: preskušanja potekajo izven držav članic Evropske unije.
English: Date of first authorisation: 19 January 2006 Date of latest renewal: 29 November 2010
Slovenian: Datum prve odobritve: 19. januar 2006 Datum zadnjega podaljšanja: 29. november 2010
English: Therefore, it is recommended that:
Slovenian: Zaradi tega je priporočljivo sledeče:
English: See sections 4.4, 4.8 and 5.3.
Slovenian: Glejte poglavja 4.4, 4.8 in 5.3.
English: Dispose of in accordance with local requirements
Slovenian: Odstranite v skladu z lokalnimi zahtevami.
English: This interference led to a false prolongation of PT and elevation of INR.
Slovenian: Ta interferenca je povzročila lažno podaljšanje PT in zvišanje INR.
English: However, from a microbiological point of view the product should be used immediately.
Slovenian: Vendar je z mikrobiološkega stališča treba zdravilo uporabiti takoj.
English: A course of treatment usually lasts for 1 to 2 weeks for skin infections.
Slovenian: Postopek zdravljenja običajno traja od 1 do 2 tednov pri okužbah kože.
English: Cubicin will usually be given to you by a doctor or a nurse.
Slovenian: Zdravilo Cubicin vam bo navadno dal zdravnik ali medicinska sestra.
English: For blood or heart infections and skin infections your doctor will decide how long you should be treated.
Slovenian: Pri okužbah krvi ali srca in okužbah kože bo zdravnik odločil, kako dolgo vas bo treba zdraviti.
English: 1**, cough
Slovenian: 1**, kašelj
English: Mitochondrial loss/damage was also observed; however the role and significance of this finding in the overall pathology are unknown.
Slovenian: Opažali so tudi izgubo/poškodbe mitohondrijev, vendar vloga in pomen te ugotovitve v okviru celotne patologije nista znana.
English: This serious allergic reaction needs immediate medical attention.
Slovenian: V primeru resne alergijske reakcije je potrebna takojšnja zdravniška pomoč.
English: If your kidneys do not work well, you may receive Cubicin less often, e.g. once every other day.
Slovenian: Če vaše ledvice ne delujejo dobro, boste prejemali zdravilo Cubicin manj pogosto, npr. vsak drugi dan.
English: Daptomycin is an antibacterial that can stop the growth of certain bacteria.
Slovenian: Daptomicin je protibakterijsko zdravilo, ki lahko zaustavi rast določenih bakterij.
English: The prevalence of resistance may vary geographically and over time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Slovenian: Prevalenca občutljivosti lahko geografsko in časovno variira za izbrane vrste in lokalne informacije o rezistenci so zaželene, še posebno kadar gre za zdravljenje hudih okužb.
English: However, there is currently no evidence that a dose reduction is required (see section 5.2).
Slovenian: Vendar pa trenutno ni nikakršnih dokazov, da je potrebno odmerke zmanjšati (glejte poglavje 5.2).
English: The use of antibacterials may promote the overgrowth of non-susceptible micro-organisms.
Slovenian: Uporaba protibakterijskih zdravil lahko pospeši prekomerno rast neobčutljivih mikroorganizmov.
English: Cubicin may interfere with laboratory tests that measure how well your blood is clotting.
Slovenian: Zdravilo Cubicin lahko moti laboratorijske teste, s katerimi izmerijo, kako dobro se strjuje vaša kri.
English: • Patients should be reviewed regularly while on therapy for any signs or symptoms that might represent myopathy.
Slovenian: • Bolnike je treba med zdravljenjem redno pregledovati, da opazimo kakršne koli znake ali simptome, ki bi lahko predstavljali miopatijo.
English: The duration of therapy should be in accordance with available official recommendations.
Slovenian: Trajanje zdravljenja naj bo v skladu z veljavnimi strokovnimi smernicami.
English: Serious side effects with frequency not known (frequency cannot be estimated from the available data)
Slovenian: Resni neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
English: This medicinal product must not be mixed with other medicinal products except those mentioned above.
Slovenian: Tega zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so navedena zgoraj.
English: The differences noted are most likely due to the normal reduction in renal function observed in the geriatric population.
Slovenian: Do opaženih razlik je po vsej verjetnosti prišlo zaradi normalnega upada ledvične funkcije, ki jo je mogoče opaziti pri populaciji starejših.
English: Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or weakness.
Slovenian: Takoj povejte zdravniku, če občutite nepojasnjene bolečine v mišicah, občutljivost ali šibkost.
English: If superinfection occurs during therapy, appropriate measures should be taken.
Slovenian: Če do superinfekcije pride med terapijo, je treba ustrezno ukrepati.
English: The most common type of infection treated was wound infection (38% of patients), while 21% had major abscesses.
Slovenian: Najbolj pogost tip zdravljene okužbe je bila okužba rane (38 % bolnikov), medtem ko je imelo 21 % bolnikov manjše abscese.
English: Detailed instructions for use and handling are given at the end of the leaflet.
Slovenian: Podrobna navodila za uporabo in rokovanje z zdravilom so navedena na koncu navodila za uporabo.
English: If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: Če ste alergični na daptomicin ali natrijev hidroksid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Regular monitoring of renal function is advised (see also section 5.2).
Slovenian: Priporočeno je redno kontroliranje ledvične funkcije (glejte tudi poglavje 5.2).
English: Mechanisms of resistance
Slovenian: Mehanizmi rezistence