FrancophonIA/ELRC3.0 huggingface dataset:
English: It works by blocking the phosphodiesterase enzyme which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Croatian: Djeluje blokiranjem enzima fosfodiesteraze koji inače razgrađuje tvar poznatu kao ciklički gvanozin monofosfat (cGMP).
English: • patients with severe liver disease or end-stage kidney disease requiring dialysis;
Croatian: • bolesnici s teškom bolesti jetre ili terminalnom bolesti bubrega koji trebaju dijalizu;
English: One study was carried out in diabetic men and another in men who had had their prostate gland removed.
Croatian: Jedno ispitivanje provedeno je na dijabetičarima, a drugo na muškarcima kojima je odstranjena prostata.
English: Vivanza must not be used in people who are hypersensitive (allergic) to vardenafil or any of the other ingredients.
Croatian: Lijek Vivanza ne smiju koristiti osobe koje su preosjetljive (alergične) na vardenafil ili bilo koji drugi sastojak lijeka.
English: The CHMP decided that Vivanza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Vivanza nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Vivanza must not be taken with nitrates (medicines used to treat angina).
Croatian: Lijek Vivanza ne smije se uzimati s nitratima (lijekovima koji se koriste za liječenje angine).
English: It must also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non arteritic anterior ischemic optic neuropathy or NAION).
Croatian: Lijek također ne smiju uzimati bolesnici koji su doživjeli gubitak vida zbog problema s dotokom krvi u očni živac (nearteritička prednja ishemička neuropatija ili NAION).
English: In addition, Vivanza must not be taken with medicines known as guanylate cyclase stimulators, including riociguat (used to treat pulmonary hypertension [high blood pressure in the lungs]).
Croatian: Osim toga, lijek Vivanza ne smije se uzimati sa stimulatorima gvanilat ciklaze, uključujući riocigvat (koji se koristi za liječenje pulmonalne hipertenzije [visokog krvnog tlaka u plućima]).
English: The full EPAR for Vivanza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Vivanza nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Više informacija o terapiji lijekom Vivanza pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: What benefit has Vivanza shown during the studies?
Croatian: Koje su koristi lijeka Vivanza dokazane u ispitivanjima?
English: Why has Vivanza been approved?
Croatian: Zašto je lijek Vivanza odobren?
English: How does Vivanza work?
Croatian: Kako Vivanza djeluje?
English: What is Vivanza used for?
Croatian: Za što se Vivanza koristi?
English: For the full list of all side effects reported with Vivanza, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Vivanza potražite u uputi o lijeku.
English: How is Vivanza used?
Croatian: Kako se Vivanza koristi?
English: How has Vivanza been studied?
Croatian: Kako je lijek Vivanza ispitivan?
English: This is exacerbated by the low number of new antimicrobials having been authorised over the past few years.
Croatian: Problem pogoršava mali broj novih antimikrobnih proizvoda odobrenih u posljednjih nekoliko godina.
English: The environment in which the Agency operates is constantly changing and evolving.
Croatian: Okruženje u kojem Agencija djeluje neprestano se mijenja i razvija.
English: Antimicrobial resistance (AMR) is a growing problem for both humans and animals.
Croatian: Antimikrobna rezistencija (AMR) sve je veći problem za ljude i životinje.
English: Globalisation
Croatian: Globalizacija
English: Information technology and social media
Croatian: Informacijska tehnologija i društveni mediji
English: • Enhance cooperation within the Network, as well as with European and international partners.
Croatian: • Unaprjeđivati suradnju unutar mreže kao i suradnju s europskim i međunarodnim partnerima.
English: In light of the above influences and other business environment factors, the Agency has set out the following priorities for 2015:
Croatian: S obzirom na navedene utjecaje i druge čimbenike uvjeta poslovanja, Agencija je za 2015. definirala sljedeće prioritete:
English: Antimicrobial resistance and other public health threats
Croatian: Antimikrobna rezistencija i druge javnozdravstvene opasnosti
English: Planning for changes within the Agency, which will arise as a result of the implementation of the revised legislation, will start in 2015.
Croatian: Planiranje promjena u Agenciji koje će proizaći iz provedbe revidiranog zakonodavstva započet će 2015.
English: EMA priorities and key influences
Croatian: EMA-ini prioriteti i ključni utjecaji
English: Transparency
Croatian: Transparentnost
English: • Improve quality, integration and accessibility of data held by the Agency.
Croatian: • Poboljšati kvalitetu, integraciju i dostupnost podataka Agencije.
English: EMA/773839/2014 Rev. 1 Management Board
Croatian: EMA/372788/2015
English: To account for this, the Agency will reinforce its support to these stakeholder groups as well.
Croatian: Kako bi ispunila tu ulogu, Agencija će pojačati podršku i ovim zainteresiranim skupinama.
English: The process for evaluating medicines is constantly evolving.
Croatian: Proces ocjene lijekova kontinuirano se razvija.
English: YEAR 2015
Croatian: U 2015.
English: • Ensure efficient crisis management and responsiveness to public health threats, including addressing antimicrobial resistance and the availability of anti-infective treatments.
Croatian: • Osigurati učinkovito krizno upravljanje i odgovaranje na javnozdravstvene prijetnje, uključujući rješavanje pitanja antimikrobne rezistencije i dostupnosti antiinfekcijskih lijekova.
English: The network has access to thousands of experts from Member States across Europe, allowing it to source the best-possible expertise for the regulation of medicines in the European Union (EU).
Croatian: Mreža ima pristup tisućama stručnjaka iz država članica diljem Europe što joj osigurava vrhunska stručna znanja za potrebe reguliranja lijekova u Europskoj uniji (EU).
English: The European medicines regulatory system is based on a network of around 50 human and veterinary medicines regulatory authorities ('national competent authorities', or NCAs) from the 31 European Economic Area countries and the European Medicines Agency.
Croatian: Europski regulatorni sustav za lijekove čini mreža od oko 50 regulatornih tijela za humane i veterinarske lijekove (nacionalna nadležna tijela) iz 31 zemlje Europskog gospodarskog prostora i Europska agencija za lijekove.
English: The revised and improved processes, and the improved ways of working, will be embedded across the organisation as part of the transition into the continuous improvement phase.
Croatian: Revidirani i poboljšani procesi te poboljšani načini rada primjenjivat će se na razini cijele organizacije kao dio prelaska u fazu kontinuiranog poboljšanja.
English: Robust internal processes and expansion of the overall capabilities of the Network will be required.
Croatian: Bit će potrebna uspostava jasnih internih procesa i razvoj sveukupnog kapaciteta mreže.
English: The European medicines regulatory network (Network) is the cornerstone of the work and success of the European system.
Croatian: Europska regulatorna mreža za lijekove (mreža) temelj je uspješnog rada europskog sustava.
English: At the same time, there is increasing awareness of the need to avoid duplication of work done by regulators across the world and use global resources more effectively.
Croatian: Istovremeno raste svijest o nužnosti izbjegavanja dvostrukog rada koji obavljaju regulatori diljem svijeta i o potrebi učinkovitijeg korištenja globalnih resursa.
English: The implementation of the data-integration programme is the key activity for the Agency in this area.
Croatian: Provedba programa integracije podataka u tom je pogledu ključna aktivnost Agencije.
English: It will be an opportunity to look back at how much has been achieved in promoting public and animal health over 20 years and to plan for the future.
Croatian: Bit će to prilika da se osvrnemo na postignuto u pogledu promicanja zdravlja ljudi i životinja u zadnjih 20 godina i da izradimo planove za budućnost.
English: Therefore, the EMA will continue its collaboration with its EU and international partners on a number of initiatives aimed at limiting the development of AMR.
Croatian: Stoga će EMA nastaviti suradnju s EU-om i međunarodnim partnerima na brojnim inicijativama čiji je cilj spriječiti pojavu AMR-a.
English: The implementation of the policy on access to clinical data will also be a significant aspect of the Agency's transparency initiatives.
Croatian: Provedba politike pristupa kliničkim podacima bit će stoga značajan aspekt Agencijinih inicijativa za transparentnost.
English: The Agency will also continue implementing the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project, which collects information on how antimicrobial medicines are used in animals across the EU, and thus allows for a better understanding of the risk factors that lead to the development and spread of antimicrobial resistance.
Croatian: Agencija će također nastaviti provoditi europski projekt praćenja uporabe veterinarskih antimikrobnih lijekova (ESVAC) u sklopu kojeg se prikupljaju informacije o načinu uporabe antimikrobnih lijekova u životinja diljem EU-a, što omogućuje bolje razumijevanje čimbenika rizika koji dovode do razvoja i širenja antimikrobne rezistencije.
English: Society wants to see the outcomes of clinical trials, pharmacovigilance and other stages of the medicines lifecycle.
Croatian: Društvo želi vidjeti ishode kliničkih ispitivanja, farmakovigilancije i ostalih faza životnog ciklusa lijekova.
English: The Agency will also be developing and improving its public health crisis response mechanisms, building on the past experience of pandemic influenza and the ongoing work on Ebola.
Croatian: Agencija će također razvijati i poboljšavati svoje mehanizme odgovora na javnozdravstvene prijetnje na temelju prethodnih iskustava s pandemijom gripe i trenutačnog rada na problemu ebole.
English: As the Agency regulates both human and veterinary medicines, it is well placed to implement the 'One Health' approach and follow its application in tackling the AMR, both in its own work and through collaboration with its European and international partners.
Croatian: Budući da Agencija regulira humane i veterinarske lijekove, prikladno je primijeniti pristup 'One Health' (sveobuhvatno zdravlje) i koristiti ga u rješavanju problema s AMR-om, kako u vlastitom radu tako i u suradnji s europskim i međunarodnim partnerima.
English: Key influences
Croatian: Glavni utjecaji
English: This means the environment trends, workload forecasts and implementation of a number of objectives and activities described in this work programme will impact the national authorities and their work as well.
Croatian: To znači da će trendovi u okruženju, predviđanja radnog opterećenja i provedba brojnih ciljeva i aktivnosti opisanih u ovom planu rada utjecati i na rad nacionalnih tijela.
English: As a result, development of the EU Clinical Trial Portal and Database, and other associated systems, will be one of the key focus areas of the Agency in the coming years.
Croatian: Stoga će u narednim godinama razvoj europskog portala i baze podataka za klinička ispitivanja i drugih povezanih sustava biti jedan od glavnih fokusa rada Agencije.
English: The Clinical Trials Regulation was published in May 2014, assigning the Agency the responsibility for developing the systems necessary to implement the Regulation.
Croatian: Uredbom o kliničkim ispitivanjima, koja je donesena u svibnju 2014., Agencija je dobila zadatak da razvije sustav potreban za provedbu Uredbe.
English: The discussions are expected to continue over the next years, with the adoption of the legislation expected in 2016.
Croatian: Predviđa se da će se rasprave odvijati sljedećih nekoliko godina, a donošenje zakonodavstva očekuje se 2016.
English: To manage this, and to improve pharmacovigilance activities and the safety of European patients, the Agency will be developing further data sources.
Croatian: U tu svrhu i radi unaprjeđenja aktivnosti na području farmakovigilancije i sigurnosti bolesnika u Europi, Agencija će razvijati dodatne izvore informacija.
English: Along with SMEs, academia and public-private partnerships are also becoming an increasingly important source of innovation in medicines.
Croatian: Osim MSP-ova, akademska zajednica i javno-privatna partnerstva također postaju sve važniji izvor inovacija u razvoju lijekova.
English: Transparency of the decision-making process throughout the lifecycle of medicines remains a key driver.
Croatian: Transparentnost u donošenju odluka tijekom životnog ciklusa lijekova ostaje bitan pokretač.
English: European medicines regulatory network
Croatian: Europska regulatorna mreža za lijekove
English: Scientific advancement and managing complexity to facilitate patient access to medicines
Croatian: Znanstveni napredak i ovladavanje složenošću radi lakšeg pristupa bolesnika lijekovima
English: In addition, the requests from stakeholders will increasingly relate not only to accessing data, but also to interpretation and analyses of those data.
Croatian: Osim toga, zahtjevi dionika neće se odnositi samo na pristup podacima, nego sve više i na tumačenje i analizu tih podataka.
English: • Provide technical support to the European Commission during the co-decision process for the proposal on revision of the veterinary medicines legislation in the Council and the European
Croatian: • Pružati tehničku podršku Europskoj komisiji u procesu suodlučivanja o prijedlozima za reviziju propisa o veterinarsko-medicinskim proizvodima u Vijeću i Europskom parlamentu.
English: Priorities
Croatian: Prioriteti
English: Following closely these developments and ensuring availability of the required expertise will remain an important part of the Agency's agenda.
Croatian: Pomno praćenje tih pojava i osiguranje dostupnosti potrebne stručnosti ostat će važan dio Agencijinog rada.
English: • Further increase transparency and implement stakeholder and communication strategies.
Croatian: • Povećavati transparentnost i implementirati strategije suradnje i komunikacije s dionicima.
English: In the coming years, the Agency expects a significant increase in its activities, both in terms of volumes (e.g. scientific advice and pharmacovigilance) and in terms of complexity of products, scientific issues and procedures, due to the scientific development.
Croatian: U nadolazećem razdoblju Agencija očekuje znatan porast opsega svojih aktivnosti, kako u pogledu količine (npr. davanje znanstvenih savjeta i farmakovigilancija) tako i u pogledu složenosti proizvoda, znanstvenih pitanja i procedura uslijed napretka znanosti.
English: The final elements of the EU's pharmacovigilance legislation will be implemented during 2015 and 2016.
Croatian: Potpuna provedba europskog zakonodavstva vezanog za farmakovigilanciju bit će dovršena tijekom 2015. i 2016.
English: Hence, the Agency will additionally support efforts to increase international worksharing in all areas, as well as support convergence of international practices and work within international coalitions to encourage better and more effective use of global regulatory resources.
Croatian: Zbog toga će Agencija dodatno podržavati napore na povećanju međunarodne suradnje na svim poljima, kao i konvergenciju međunarodnih praksi i rada unutar međunarodnih tijela s ciljem boljeg i učinkovitijeg korištenja globalnih regulatornih resursa.
English: The NCAs and the Agency will also need to prepare for the upcoming revision of the fee legislation, to ensure adequate financing and sustainability of the Network.
Croatian: Nacionalna nadležna tijela i Agencija morat će se pripremiti i za nadolazeću reviziju propisa o naknadama kako bi se osiguralo odgovarajuće financiranje i održivost mreže.
English: This year, 2015, will be the 20th anniversary of the inauguration of the EMA, and the beginning of not only centralised approval of medicines, but of the whole European medicines network.
Croatian: Ove godine, 2015., navršava se 20 godina od osnutka EMA-e kao i od početka ne samo centraliziranog odobravanja lijekova, nego i djelovanja europske mreže u području lijekova.
English: As part of this work, the Agency will continue contributing to the work of the Transatlantic Task Force on Antimicrobial Resistance (TATFAR), which aims to increase levels of communication, coordination and cooperation between the EU and the United States on human and veterinary antimicrobials.
Croatian: U tom smislu Agencija će nastaviti doprinositi radu Transatlantske radne skupine za antimikrobnu rezistenciju (TATFAR) kojoj je cilj unaprijediti komunikaciju, koordinaciju i suradnju između Europske unije i Sjedinjenih Država u području humanih i veterinarskih antimikrobnih proizvoda.
English: To deliver on its responsibilities, the EMA works closely with the NCAs.
Croatian: Kako bi ispunila svoje zadaće, EMA usko surađuje s nacionalnim nadležnim tijelima.
English: At the same time, the ability to manage the increasing workload is on occasion limited by the current capacity of the Network, and finding sustainable solutions for maintaining and increasing the Network's capacity will be an important focus area.
Croatian: Trenutačno ograničen kapacitet mreže ponekad nije dovoljan za sve veće radno opterećenje te će u fokusu biti pronalaženje održivih rješenja za održavanje i povećanje kapaciteta mreže.
English: In 2015, the Agency will be capitalising on its recent programme to increase the effectiveness and efficiency of activities.
Croatian: Agencija će osjetiti prednosti svojeg najnovijeg programa za povećanje učinkovitosti i efikasnosti aktivnosti.
English: As part of this change, the volume of data and information to be managed and the number of procedures to be run will increase significantly over the next years.
Croatian: Kao posljedica ovih promjena sljedećih će se godina znatno povećati količina podataka i informacija kojima treba upravljati kao i broj procedura koje treba provesti.
English: Therefore, the Agency will continue providing technical support to the European Commission (‘Commission', or EC) with respect to discussion in the European Parliament and the Council on their proposal for revision of the veterinary legislation, including on amendments to the framework for authorisation of innovative veterinary medicines, simplification of post-authorisation maintenance of veterinary products, pharmacovigilance and other aspects.
Croatian: Stoga će Agencija nastaviti pružati tehničku podršku Europskoj komisiji (Komisija ili EK) za potrebe rasprave u Europskom parlamentu i Vijeću o njihovom prijedlogu revizije zakonodavstva o veterinarstvu, uključujući izmjene okvira za odobravanje inovativnih veterinarsko-medicinskih proizvoda, pojednostavljenje procesa nakon autorizacije veterinarskih proizvoda, farmakovigilanciju i druge aspekte.
English: Improving the quality and efficiency of our work
Croatian: Unaprjeđenje kvalitete i učinkovitosti rada
English: • Facilitate early stages of medicines development in both the human and veterinary areas.
Croatian: • Poticati rane faze razvoja lijekova u područjima humane i veterinarske medicine.
English: The ever-increasing role of information technology in health-related matters, including use of e-health records and databases, mobile communications and social media by consumers and healthcare professionals, also demands that surveillance methods evolve to consider these developments.
Croatian: Sve važnija uloga informacijske tehnologije u zdravstvenim pitanjima, uključujući korištenje elektroničkih zdravstvenih kartona i baza podataka, mobilnih komunikacijskih sredstava i društvenih medija od strane potrošača i zdravstvenih djelatnika također zahtijeva razvoj metoda praćenja tih trendova.
English: All aspects of the work of the Agency, from the initial evaluation through to postauthorisation monitoring, are thus becoming subject to more intense scrutiny by the stakeholders and the community as a whole, with impact on public trust in the Agency's work.
Croatian: Svi aspekti rada Agencije, od početne evaluacije sve do praćenja nakon odobravanja, pod sve su budnijim nadzorom dionika i zajednice u cjelini, što utječe na povjerenje javnosti prema radu Agencije.
English: Ensuring more prospective medicines reach their patients in such an environment requires adapting and simplifying our processes and approaches, making them more open, flexible and easier to navigate for the sponsors, especially the SMEs.
Croatian: Kako bismo se pobrinuli da u takvom okruženju što više budućih lijekova dospije do bolesnika, moramo se prilagoditi i pojednostaviti procese i pristupe i učiniti ih otvorenijima, fleksibilnijima i preglednijima za naručitelje ispitivanja, osobito MSP-ove.
English: • Deliver business activities to a high level of quality, efficiency and consistency in both the human and veterinary areas.
Croatian: • Postići visoku kvalitetu poslovnih aktivnosti, učinkovitosti i dosljednosti u područjima humane i veterinarske medicine.
English: In addition, the Agency is reviewing the available regulatory tools and their use, to allow patient access to medicines for conditions with unmet medical need, and exploring concepts such as adaptive pathways and specific mechanisms to support innovative medicines with high public-health potential.
Croatian: Osim toga, Agencija je pristupila reviziji dostupnih regulatornih alata i njihove primjene kako bi bolesnicima omogućila pristup lijekovima za stanja za koja ne postoji adekvatan medicinski odgovor, te ispituje koncepte kao što su prilagodljive procedure i specifični mehanizmi kojima bi pružala podršku inovativnim lijekovima s visokim potencijalom za zdravlje ljudi.
English: • Implement pharmacovigilance legislation and the clinical trials legislation.
Croatian: • Provoditi zakonodavstvo iz područja farmakovigilancije i kliničkih ispitivanja.
English: The increasing workload will call for higher involvement of the NCAs.
Croatian: Veće radno opterećenje zahtijevat će veći angažman nacionalnih nadležnih tijela.
English: Pharmacovigilance and clinical trials legislation
Croatian: Zakonodavstvo u području farmakovigilancije i kliničkih ispitivanja
English: As a result, increased focus on ensuring that medicines tested and manufactured outside the EU meet the EU requirements will drive efforts to develop and strengthen collaboration with international partners regarding collaborative inspections, information exchange, capacity building and greater mutual reliance.
Croatian: Stoga će u nastojanju da lijekovi testirani i proizvedeni izvan EU-a udovoljavaju europskim zahtjevima naglasak biti na razvoju i jačanju suradnje s međunarodnim partnerima u pitanjima inspekcije, razmjene informacija, izgradnje kapaciteta i veće međusobno povjerenje.
English: Veterinary medicines legislation
Croatian: Zakonodavstvo u području veterinarsko-medicinskih proizvoda
English: As a result of full implementation of the legislation, the coordinating role of the Agency in the monitoring of all EU medicines, irrespective of their route of authorisation, will increase, and with it the scope of the Agency's responsibilities in the pharmacovigilance field.
Croatian: Potpunom provedbom zakonodavstva povećat će se i uloga Agencije kao koordinatora u praćenju svih lijekova na području EU-a, neovisno o mehanizmu njihovog odobravanja, a time i opseg odgovornosti Agencije u području farmakovigilancije.