FrancophonIA/ELRC3.0 huggingface dataset:
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic acid (ASA).
Croatian: Klopidogrel/acetilsalicilatna kiselina Zentiva 75 mg/100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 75 mg klopidogrela (u obliku klopidogrelhidrogensulfata) i 100 mg acetilsalicilatne kiseline (ASK).
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets The active substances are clopidogrel and acetylsalicylic acid (ASA).
Croatian: Klopidogrel/acetilsalicilatna kiselina Zentiva 75 mg/100 mg filmom obložene tablete Djelatne tvari su klopidogrel i acetilsalicilatna kiselina (ASK).
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Klopidogrel/acetisalicilatna kiselina Zentiva 75 mg/75 mg
English: You should stop other clopidogrel treatment while you are taking Clopidogrel/Acetylsalicylic acid Zentiva.
Croatian: Ako prestanete uzimati lijek Klopidogrel/acetisalicilatna kiselina Zentiva
English: This randomized, open-label trial included ACS patients requiring PCI.
Croatian: Timing of Platelet Inhibition after Acute Coronary Syndrome) Ovo randomizirano, otvoreno ispitivanje uključivalo je bolesnike s akutnim koronarnim sindromom u kojih je bila potrebna perkutana koronarna intervencija (PCI).
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets
Croatian: Klopidogrel/acetilsalicilatna kiselina Zentiva 75 mg/75 mg filmom obložene tablete Klopidogrel/acetilsalicilatna kiselina Zentiva 75 mg/100 mg filmom obložene tablete
English: Hydrogenated castor oil Stearic acid
Croatian: Klopidogrel/acetisalicilatna kiselina Zentiva sadrži hidrogenirano ricinusovo ulje
English: It is preferable not to take this medicine during first and second trimesters of pregnancy.
Croatian: Ne preporučuje se uzimanje lijeka Klopidogrel/acetisalicilatna kiselina Zentiva u prvom i drugom tromjesečju trudnoće.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Klopidogrel/acetisalicilatna kiselina Zentiva 75 mg/100 mg
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets Yellow, oval, slightly biconvex, engraved with «C75» on one side and «A75» on the other side.
Croatian: Klopidogrel/acetilsalicilatna kiselina Zentiva 75 mg/75 mg filmom obložene tablete Žute, ovalne, blago bikonveksne tablete, s utisnutim oznakama "C75" na jednoj i "A75" na drugoj strani.
English: Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic acid.
Croatian: Jedna tableta sadržava 75 mg klopidogrela (u obliku hidrogensulfata) i 75 mg acetilsalicilatne kiseline.
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets Light pink, oval, slightly biconvex, engraved with «C75» on one side and «A100» on the other side.
Croatian: Klopidogrel/acetilsalicilatna kiselina Zentiva 75 mg/100 mg filmom obložene tablete Svijetlo roze, ovalne, blago bikonveksne tablete, s utisnutim oznakama "C75" na jednoj i "A100" na drugoj strani.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg tablets clopidogrel/acetylsalicylic acid
Croatian: Klopidogrel/acetisalicilatna kiselina Zentiva 75 mg/100 mg tablete klopidogrel/acetilsalicilatna kiselina
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg tablets clopidogrel/acetylsalicylic acid
Croatian: Klopidogrel/acetisalicilatna kiselina Zentiva 75 mg/75 mg tablete klopidogrel/acetilsalicilatna kiselina
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets
Croatian: Klopidogrel/acetilsalicilatna kiselina Zentiva 75 mg/100 mg filmom obložene tablete
English: If you experience prolonged bleeding when taking Clopidogrel/Acetylsalicylic acid Zentiva If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Croatian: Ako pri uzimanju lijeka Klopidogrel/acetisalicilatna kiselina Zentiva imate produljeno krvarenje
English: Core
Croatian: Serija
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid
Croatian: Klopidogrel/acetisalicilatna kiselina Zentiva 75 mg/75 mg filmom obložene tablete klopidogrel/acetilsalicilatna kiselina
English: Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid
Croatian: Klopidogrel/acetisalicilatna kiselina Zentiva 75 mg/100 mg filmom obložene tablete klopidogrel/acetilsalicilatna kiselina
English: 28 March 2019
Croatian: 28. ožujka 2019
English: The revised policy entered into force on 30 January 2015.
Croatian: Revidirana politika stupila je na snagu 30. siječnja 2015.
English: It began operating in 1995.
Croatian: S radom je započela 1995.
English: EMA/338312/2016 Rev. 2 European Medicines Agency
Croatian: EMA/338312/2016, rev.
English: Each EU Member State has its own national authorisation procedures.
Croatian: Svaka država članica EU-a ima vlastite nacionalne postupke odobrenja.
English: • Transparency
Croatian: • Transparentnost
English: Annual review of policies on independence
Croatian: Godišnja revizija politika o neovisnosti
English: • the type of activity that the expert will be undertaking.
Croatian: • vrsti aktivnosti koju će stručnjak obavljati.
English: The Agency has separate policies in place for these groups.
Croatian: Agencija je uspostavila zasebne politike za te grupe.
English: • for some interests, such as financial interests, there continues to be no cooling-off period required when the interest is no longer present.
Croatian: • za neke interese, kao što su financijski, i dalje nije potrebno razdoblje mirovanja kada interes više nije prisutan.
English: The centralised procedure is compulsory for:
Croatian: Centralizirani je postupak obavezan za:
English: All other DoIs are available on request.
Croatian: Sve druge izjave o interesima dostupne su na zahtjev.
English: Information about these can normally be found on the websites of the national competent authorities:
Croatian: Informacije o njima obično se mogu pronaći na internetskim stranicama nacionalnih nadležnih tijela:
English: For more information, see Section 3.1.
Croatian: Za dodatne informacije pogledajte dio 3.1.
English: Restrictions to involvement decrease over time and make a distinction between current interests and interests within the last three years;
Croatian: Ograničenja sudjelovanja s vremenom se smanjuju te se razlikuju trenutačni interesi i interesi unutar posljednje tri godine;
English: EMA subsequently updated the policy:
Croatian: EMA je naknadno ažurirala politiku:
English: The system for regulating medicines in Europe is unique in the world.
Croatian: Sustav za regulaciju lijekova u Europi jedinstven je u svijetu.
English: They are selected to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographical spread within the EU.
Croatian: Oni se odabiru kako bi se zajamčila najviša razina specijaliziranih kvalifikacija, širok spektar relevantnog stručnog znanja i najšira moguća geografska rasprostranjenost u EU-u.
English: • for the majority of declared interests a three-year cooling-off period is foreseen.
Croatian: • za većinu izjavljenih interesa predviđa se trogodišnje razdoblje mirovanja.
English: • whose authorisation would be in the interest of public or animal health at EU level.
Croatian: • čije bi odobrenje bilo u interesu javnog zdravlja ili zdravlja životinja na razini EU-a.
English: • developing guidelines and setting standards;
Croatian: • razvija smjernice i postavlja standarde;
English: EMA is governed by an independent Management Board.
Croatian: EMA-om upravlja nezavisni Upravni odbor.
English: In addition to the members, the Management Board also has one observer each from Iceland, Liechtenstein and Norway.
Croatian: Osim članova, Upravni odbor ima i po jednog promatrača iz Islanda, Lihtenštajna i Norveške.
English: • Accelerates the exchange of information on important issues, such as the safety of medicines.
Croatian: • Ubrzava razmjenu informacija o važnim pitanjima, kao što je sigurnost lijekova.
English: The revised rules are similar to the principles adopted for committee members and experts.
Croatian: Revidirana pravila slična su načelima koja su usvojena za članove odbora i stručnjake.
English: The Management Board consists of 35 members, appointed to act in the public interest, who do not represent any government, organisation or sector.
Croatian: Upravni odbor čini 35 članova, imenovanih kako bi djelovali u javnom interesu, koji ne predstavljaju nijednu vladu, organizaciju ili sektor.
English: EMA is a decentralised agency of the European Union (EU), located in Amsterdam.
Croatian: EMA je decentralizirana agencija Europske unije (EU) sa sjedištem u Amsterdamu.
English: Board members are appointed for a three-year term, which may be renewed.
Croatian: Članovi Odbora imenuju se na trogodišnje razdoblje, koje se može produljiti.
English: Please note that the document contains links to sections of the EMA website, some of which are only available in English.
Croatian: Imajte na umu da dokument sadrži poveznice na dijelove EMA-inih internetskih stranica, od kojih su neke dostupne samo na engleskom jeziku.
English: This supports an exchange of information on a number of issues, including:
Croatian: Na taj se način podupire razmjena informacija o brojnim pitanjima, uključujući:
English: • Single evaluation by European experts.
Croatian: • Europski stručnjaci vrše jedinstvenu procjenu.
English: − viral diseases.
Croatian: − virusnih bolesti.
English: • to restrict involvement of experts in the assessment of medicines if they plan to take up a job in the pharmaceutical industry in May 2015.
Croatian: • kako bi se ograničilo sudjelovanje stručnjaka u procjeni lijekova ako planiraju prihvatiti posao u farmaceutskoj industriji, u svibnju 2015.
English: • Product information available in all EU languages at the same time.
Croatian: • Informacije o proizvodu istovremeno su dostupne na svim jezicima Europske unije.
English: The Management Board is made up of the following members:
Croatian: Upravni odbor čine sljedeći članovi:
English: The representatives of the Member States and of the Commission may have alternates.
Croatian: Predstavnici država članica i Komisije mogu imati zamjenike.
English: • the nature of the interests declared;
Croatian: • prirodi izjavljenog interesa;
English: Experts can only be involved once the Agency has assessed their declaration of interests.
Croatian: Stručnjaci se mogu uključiti tek nakon što Agencija procijeni njihovu izjavu o interesima.
English: The representatives of the Member States, European Commission and European Parliament are appointed directly by the Member State and institution concerned.
Croatian: Predstavnike država članica, Europske komisije i Europskog parlamenta imenuju izravno država članica i relevantna institucija.
English: EMA does not:
Croatian: EMA ne radi sljedeće:
English: • scientific advice and protocol assistance;
Croatian: • znanstveni savjeti i pomoć za protokole;
English: It includes a number of measures which take into account the nature of the declared interest before determining the length of time any restrictions may apply:
Croatian: Politika uključuje niz mjera kojima se uzima u obzir priroda izjavljenog interesa prije određivanja razdoblja tijekom kojega se mogu primjenjivati ograničenja:
English: • containing new active substances for indications other than those stated above;
Croatian: • koji sadrže nove djelatne tvari za indikacije koje nisu navedene gore;
English: − cancer;
Croatian: − raka;
English: The Board sets the Agency's budget, approves the annual work programme and is responsible for ensuring that the Agency works effectively and co-operates successfully with partner organisations across the EU and beyond.
Croatian: Odbor utvrđuje proračun Agencije, odobrava godišnji program rada i zadužen je za osiguravanje da Agencija učinkovito radi i uspješno surađuje s partnerskim organizacijama širom Europske unije i izvan nje.
English: The Board also gives its opinion on the Agency's annual accounts.
Croatian: Odbor također daje mišljenje o godišnjim financijskim izvješćima Agencije.
English: Composition
Croatian: Sastav
English: EMA continuously monitors and supervises the safety of medicines that have been authorised in the EU, to ensure that their benefits outweigh their risks.
Croatian: EMA neprekidno prati i nadzire sigurnost lijekova koji su odobreni u EU-u kako bi se osiguralo da su njihove koristi veće od rizika.
English: − human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);
Croatian: − virusa humane imunodeficijencije (HIV) ili sindroma stečene imunodeficijencije (AIDS);
English: Provide information to healthcare professionals and patients
Croatian: Pružanje informacija zdravstvenim stručnjacima i bolesnicima
English: Ensuring the independence of its scientific assessments is a high priority for EMA.
Croatian: Osiguravanje neovisnosti znanstvenih procjena jedan je od glavnih prioriteta u EMA-i.
English: The report includes results of breach-of-trust procedures, any controls carried out, initiatives planned for the following year and recommendations for improvement.
Croatian: Izvješće obuhvaća rezultate postupaka u slučaju zlouporabe povjerenja, sve provedene kontrole, inicijative koje se planiraju za sljedeću godinu te preporuke za poboljšanje.
English: The vast majority of medicines available in the EU are authorised at national level.
Croatian: Velika većina lijekova dostupnih u EU-u odobrava se na nacionalnoj razini.
English: Decisions about price and reimbursement take place at the level of each Member State considering the potential role and use of the medicine in the context of the national health system of that country.
Croatian: Odluke o cijeni i nadoknadi troškova donose se na razini svake države članice, s obzirom na potencijalnu ulogu i primjenu lijeka u kontekstu nacionalnog zdravstvenog sustava te zemlje.
English: • Creates certainty for patients, healthcare professionals, industry and governments by ensuring consistent standards and use of best available expertise;
Croatian: • Pruža sigurnost bolesnicima, zdravstvenim radnicima, industriji i vladama tako što osigurava dosljedne standarde i uporabu najboljeg dostupnog stručnog znanja;
English: This document provides an overview of the main responsibilities of the European Medicines Agency (EMA).
Croatian: U ovom se dokumentu pruža pregled glavnih dužnosti Europske agencije za lijekove (EMA).
English: − neurodegenerative diseases;
Croatian: − neurodegenerativnih bolesti;
English: • medicines derived from biotechnology processes, such as genetic engineering;
Croatian: • lijekove dobivene iz biotehnoloških procesa, poput genetičkog inženjerstva;
English: New staff must get rid of any interests they have before they can start to work at the Agency.
Croatian: Novi članovi osoblja moraju se osloboditi svih interesa prije početka rada u Agenciji.
English: • provide medical advice.
Croatian: • ne pruža medicinske savjete.
English: The four ‘civil society' Board members (patients', doctors' and veterinarians' representatives) are appointed by the Council of the European Union, after consultation of the European Parliament.
Croatian: Četiri člana Odbora koji pripadaju „civilnom društvu” (predstavnici bolesnika, liječnika i veterinara) imenuje Vijeće Europske unije nakon savjetovanja s Europskim parlamentom.
English: The Agency also implements policies and procedures to ensure its works independently, openly and transparently and upholds the highest standards in its scientific recommendations.
Croatian: Agencija također provodi pravila i postupke kako bi se osiguralo da djeluje nezavisno, otvoreno i transparentno te da se pridržava najviših standarda u svojim znanstvenim preporukama.
English: This restriction is reflected in the guidance document.
Croatian: To je ograničenje sadržano u dokumentu sa smjernicama.
English: Some of the data are supplied by the Member States and centrally managed by EMA.
Croatian: Dio podataka pružaju države članice, a njima centralno upravlja EMA.
English: Facilitate development and access to medicines
Croatian: Olakšavanje razvoja i pristupa lijekovima
English: The majority of medicines available in the EU were authorised at national level, either because they were authorised before EMA's creation or they were not in the scope of the centralised procedure.
Croatian: Većina lijekova dostupnih u EU-u odobrena je na nacionalnoj razini, zato što su odobreni prije osnivanja EMA-e ili zato što nisu pripadali području primjene centraliziranog postupka.
English: The aim is to mobilise the best expertise for medicines evaluation, regardless of where experts are based.
Croatian: Cilj jest mobilizirati najbolje stručne timove za procjenu lijekova, bez obzira na to gdje se ti stručnjaci nalaze.
English: • informing the public on the safety of medicines and cooperating with external parties, in particular representatives of patients and healthcare professionals.
Croatian: • informira javnost o sigurnosti lijekova i surađuje s vanjskim stranama, posebice s predstavnicima bolesnika i zdravstvenih stručnjaka.
English: EMA is a networking organisation whose activities involve thousands of experts from across Europe.
Croatian: EMA je mrežna organizacija čije aktivnosti uključuju tisuće stručnjaka iz svih dijelova Europe.
English: The Agency also seeks to publish clear and up-to-date information on how it operates, including planning and reporting documents and information on funding, financial management and budgetary reporting.
Croatian: Agencija također nastoji objavljivati jasne i ažurne informacije o svom radu, uključujući dokumente o planiranju i izvještavanju te informacije o financiranju, financijskom upravljanju i proračunskom izvještavanju.
English: About us
Croatian: O nama
English: The Agency publishes clear and impartial information about medicines and their approved uses.
Croatian: Agencija objavljuje jasne i nepristrane informacije o lijekovima i njihovim odobrenim primjenama.
English: Similarly, requirements for chairs and members in a lead role, e.g. rapporteurs, are stricter than requirements for the other committee members.
Croatian: Slično tome, zahtjevi za predsjednike i članove na vodećim pozicijama, npr. izvjestitelje, stroži su od zahtjeva za druge članove odbora.
English: EMA protects public and animal health in the EU Member States, as well as the countries of the European Economic Area (EEA), by ensuring that all medicines available on the EU market are safe, effective and of high quality.
Croatian: EMA štiti zdravlje ljudi i životinja u državama članicama EU-a, kao i u zemljama Europskoga gospodarskog prostora (EGP), tako što osigurava da su svi lijekovi dostupni na tržištu EU-a sigurni, djelotvorni i kvalitetni.
English: • Medicines are authorised for all EU citizens at the same time.
Croatian: • Lijekovi se istovremeno odobravaju za sve državljane EU-a.
English: The regulatory network also includes the European Commission , whose principal role in the European system is to take binding decisions based on the scientific recommendations delivered by EMA.
Croatian: Regulatorna mreža također uključuje Europsku komisiju , čija je osnovna uloga u europskom sustavu usvajati obvezujuće odluke na temelju znanstvenih preporuka EMA-e.
English: Requirements for experts who are members of scientific committees are stricter than for those participating in advisory bodies and ad-hoc expert groups.
Croatian: Zahtjevi za stručnjake koji su članovi znanstvenih odbora ostaju stroži nego za one koji sudjeluju u savjetodavnim tijelima i ad hoc stručnim skupinama.
English: • Reduces the administrative burden through the centralised authorisation procedure, helping medicines to reach patients faster;
Croatian: • Smanjuje administrativno opterećenje putem centraliziranog postupka odobravanja, čime bolesnici brže dolaze do lijekova;
English: Benefits for EU citizens
Croatian: Prednosti za državljane EU-a
English: • take decisions on the price or availability of medicines.
Croatian: • ne donosi odluke o cijeni ili dostupnosti lijekova.
English: Patents having effect in most European countries may be obtained either nationally, via national patent offices, or via a centralised process at the European Patent Office;
Croatian: Patenti koji su na snazi u većini europskih zemalja mogu se dobiti na nacionalnoj razini putem ureda za patente ili putem centraliziranog postupka u Europskom uredu za patente;
English: For more information on the authorisation routes of medicines in the EU, see Chapter 2 of this document on the Authorisation of medicines;
Croatian: Više informacija o kanalima odobravanja lijekova u EU-u potražite u 2. poglavlju ovog dokumenta, Odobravanje lijekova;
English: In addition, the Agency has a number of working parties and related groups, which the committees can consult on scientific issues relating to their particular field of expertise.
Croatian: Osim toga, Agencija ima niz radnih grupa i drugih povezanih skupina s kojima se odbori mogu savjetovati u znanstvenim pitanjima povezanima s njihovim stručnim područjima.
English: This helps to reduce duplication and supports efficient and effective regulation of medicines across the EU.
Croatian: Time se umanjuje mogućnost udvostručenja te se podržava učinkovita i djelotvorna regulacija lijekova diljem EU-a.
English: • scientific guidelines on requirements for the quality, safety and efficacy testing of medicines;
Croatian: • znanstvene smjernice o zahtjevima testiranja kvalitete, sigurnosti i djelotvornosti lijekova;
English: For more information see European Commission: Medicinal products for human use;
Croatian: Više informacija potražite pod Europska komisija: Lijekovi za humanu uporabu ;
English: To fulfil its mission, the EMA works closely with national competent authorities in a regulatory network.
Croatian: Da bi ispunila svoju misiju, EMA blisko surađuje s nadležnim nacionalnim tijelima u regulatornoj mreži.
English: • Enables Member States to pool resources and coordinate work to regulate medicines efficiently and effectively;
Croatian: • Mreža državama članicama omogućuje objedinjavanje resursa i koordiniranje rada kako bi se lijekovi regulirali djelotvorno i učinkovito;
English: The authorisation of clinical trials occurs at Member State level, although the Agency plays a key role in ensuring that the standards of good clinical practice are applied in cooperation with the Member States and manages a database of clinical trials carried out in the EU.
Croatian: Odobravanje kliničkih ispitivanja vrši se na razini država članica iako Agencija ima ključnu ulogu u osiguravanju da se standardi dobre kliničke prakse primjenjuju u suradnji s državama članicama te upravlja bazom podataka kliničkih ispitivanja koja se provode u EU-u.
English: The Agency operates at the heart of the network, coordinating and supporting interactions between over fifty national competent authorities for both human and veterinary medicines.
Croatian: Agencija djeluje u središtu mreže te koordinira i podržava interakciju među više od pedeset nacionalnih nadležnih tijela za humane i veterinarske lijekove.
English: All Management Board members must submit a DoI every year.
Croatian: Svi članovi Upravnog odbora svake godine moraju podnijeti izjavu o interesima.
English: They can be nominated by Member States or by the Agency itself and are made available by the national competent authorities.
Croatian: Mogu ih imenovati države članice ili sama Agencija, a na raspolaganje ih stavljaju nadležna nacionalna tijela.
English: The tasks and responsibilities of the Management Board are set out in the Agency's legal background.
Croatian: Zadaci i odgovornosti Upravnog odbora utvrđeni su pravnim okvirom Agencije.