FrancophonIA/ELRC3.0 huggingface dataset:
English: EMA brings together scientific experts from across Europe by working closely with the national regulatory authorities in European Union (EU) Member States, in a partnership known as the European medicines regulatory network (For more information, see Chapter 5).
Croatian: EMA povezuje znanstvene stručnjake iz svih dijelova Europe tako što blisko surađuje s nacionalnim nadležnim tijelima u državama članicama Europske unije, u sklopu partnerstva pod nazivom Europska regulatorna mreža za lijekove (više informacija potražite u 5. poglavlju).
English: The Agency updated the procedure in April 2015 to align it with the current version of the policy on handling competing interests and to take into account experience gained since it was first endorsed by EMA's Management Board in 2012.
Croatian: Agencija je ažurirala postupak kako bi ga uskladila s trenutačnom verzijom politike o rješavanju suprotstavljenih interesa te kako bi iskoristila iskustvo stečeno nakon 2012., kada je Upravni odbor EMA-e prvi put donio tu politiku.
English: These national authorities supply thousands of European experts to take part in EMA's scientific committees, working parties and other groups.
Croatian: Ta nacionalna tijela ustupaju tisuće europskih stručnjaka koji sudjeluju u EMA-inim znanstvenim odborima, radnim grupama i drugim skupinama.
English: • evaluate applications for the authorisation of clinical trials.
Croatian: • ne procjenjuje zahtjeve za odobrenje kliničkih ispitivanja.
English: Healthcare professionals can provide individual patients advice on medical conditions, treatments or side effects with a medicine;
Croatian: Zdravstveni radnici daju savjete pojedinačnim bolesnicima o medicinskim stanjima, liječenju ili nuspojavama lijeka;
English: − auto-immune and other immune dysfunctions;
Croatian: − autoimunih bolesti i drugih poremećaja imunosnog sustava;
English: Pooling information
Croatian: Objedinjavanje informacija
English: • carry out research or develop medicines.
Croatian: • ne provodi istraživanja i ne razvija lijekove.
English: EMA and its regulatory network partners run a scheme to enable multinational teams to assess applications for human and veterinary medicines.
Croatian: EMA i njezini regulatorni umreženi partneri uspostavili su sustav koji višenacionalnim timovima omogućuje procjenu zahtjeva za odobrenje humanih i veterinarskih lijekova.
English: What we do
Croatian: Što radimo
English: • two representatives of the European Parliament;
Croatian: • dva predstavnika Europskog parlamenta;
English: The policy on handling competing interests for Management Board members and breach-of-trust procedure aligns with the policy on handling competing interests and breach-of-trust procedure for scientific committee members and experts.
Croatian: Politika o rješavanju suprotstavljenih interesa članova Upravnog odbora i postupak u slučaju zlouporabe povjerenja u skladu je s politikom o rješavanju suprotstavljenih interesa i postupkom u slučaju zlouporabe povjerenja za članove znanstvenih odbora i stručnjake.
English: This forms part of the package of controls and reports that lead to Executive Director receiving discharge for the Agency's budget.
Croatian: To čini dio paketa kontrolnih mjera i izvješća na temelju kojih izvršni direktor dobiva razrješnicu za proračun Agencije.
English: The Agency's evaluations of marketing-authorisation applications submitted through the centralised procedure provide the basis for the authorisation of medicines in Europe.
Croatian: Procjenama zahtjeva za odobrenje za stavljanje u promet predanih putem centraliziranog postupka, koje provodi Agencija, pruža se osnova za odobrenje lijekova u Europi.
English: The mission of the EMA is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the EU.
Croatian: Misija EMA-e jest poticati znanstvenu izvrsnost u području procjene i nadzora lijekova u korist zdravlja ljudi i životinja u EU-u.
English: The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
Croatian: Europska agencija za lijekove (EMA) decentralizirana je agencija Europske unije (EU) odgovorna za znanstvenu procjenu, nadzor i praćenje sigurnosti lijekova koje razvijaju farmaceutske tvrtke za uporabu u EU-u.
English: • the decentralised procedure, whereby a medicine that has not yet been authorised in the EU
Croatian: • decentraliziranim postupkom, pri čemu se lijek koji još nije odobren u EU-u može istovremeno odobriti u nekoliko država članica EU-a.
English: The network pools resources and expertise in the EU and gives EMA access to thousands of European scientific experts who take part in the regulation of medicines.
Croatian: Mreža objedinjuje resurse i stručno znanje EU-a u bazu podataka i pruža EMA-i pristup tisućama europskih znanstvenih stručnjaka koji sudjeluju u regulaciji lijekova.
English: The completed DoIs for management staff are available on the EMA website under Agency structure.
Croatian: Popunjene izjave o interesima za upravljačko osoblje dostupne su na internetskim stranicama EMA-e u odjeljku o strukturi Agencije.
English: For more information on the IT systems EMA manages together with the EU Member States, see EU Telematics.
Croatian: Više informacija o IT sustavima kojima EMA upravlja u suradnji s državama članicama EU-a potražite pod EU telematika.
English: • two representatives of the European Commission;
Croatian: • dva predstavnika Europske komisije;
English: Pharmaceutical companies or other medicines developers carry out the research and development of medicines, who then submit the findings and test results for their products to the Agency for evaluation;
Croatian: Farmaceutske tvrtke ili drugi proizvođači lijekova provode istraživanja i razvijaju lijekove, a zatim zaključke i rezultate ispitivanja svojih lijekova šalju
English: These European experts serve as members of the Agency's scientific committees, working parties or in assessment teams supporting their members.
Croatian: Ti europski stručnjaci djeluju kao članovi znanstvenih odbora i radnih grupa Agencije ili pružaju podršku članovima timova za procjenu.
English: The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
Croatian: Agencija je odgovorna za znanstvenu procjenu, nadzor i praćenje sigurnosti lijekova koje razvijaju farmaceutske tvrtke za uporabu u EU-u.
English: Agency staff
Croatian: Osoblje Agencije
English: Evaluate applications for marketing authorisation
Croatian: Procjena zahtjeva za odobrenje za stavljanje u promet
English: The revised policy takes into account input from stakeholders at the Agency's September 2013 public workshop Best expertise vs conflicts of interests: striking the right balance.
Croatian: Revidirana politika u obzir uzima povratne informacije dionika prikupljene tijekom javne radionice Agencije pod nazivom „Najbolji stručnjaci i sukob interesa: uspostava ravnoteže” koja je održana u rujnu 2013.
English: Centralised authorisation procedure
Croatian: Centralizirani postupak odobrenja
English: • Search veterinary medicines
Croatian: • Pretraživanje lijekova za životinje
English: • one representative of doctors' organisations;
Croatian: • jedan predstavnik organizacija liječnika;
English: The Agency works by:
Croatian: Agencija djeluje na sljedeće načine:
English: • veterinary medicines for use as growth or yield enhancers.
Croatian: • veterinarske lijekove koji se rabe za poticanje rasta ili prinosa.
English: • support for early access;
Croatian: • podrška za rani pristup;
English: For more information see Pharmacovigilance.
Croatian: Više informacija potražite pod Farmakovigilancija.
English: • orphan medicines (medicines for rare diseases);
Croatian: • lijekove za rijetke bolesti (lijekovi za liječenje rijetkih bolesti);
English: Its day-to-day operations are carried out by the EMA staff, based inAmsterdam, overseen by EMA's Executive Director.
Croatian: Svakodnevne poslove obavlja osoblje EMA-e u sjedištu u Amsterdamu, pod vodstvom izvršnog direktora EMA-e.
English: Medical devices are regulated by national competent authorities in Europe.
Croatian: Medicinske proizvode reguliraju nacionalna regulatorna tijela u EU-u.
English: It has a key role to play in the 'discharge' (sign-off) process of the Agency's accounts by the European Union's budgetary authority.
Croatian: Ima ključnu ulogu u postupku davanja razrješnice (odobrenja) financijskih izvješća Agencije, koji provodi proračunsko tijelo Europske unije.
English: Handling competing interests
Croatian: Rješavanje suprotstavljenih interesa
English: For more information see:
Croatian: Više informacija potražite na:
English: The European medicines regulatory network gives EMA access to experts from across the EU, allowing it to bring together the best-available scientific expertise in the EU for the regulation of medicines.
Croatian: Europska regulatorna mreža za lijekove EMA-i pruža pristup stručnjacima iz svih dijelova EU-a te tako omogućuje objedinjavanje najboljih znanstvenih stručnjaka EU-a u području regulacije lijekova.
English: Management Board members
Croatian: Članovi Upravnog odbora
English: EMA's Management Board adopted the current version of the policy and trust of-breach procedure in December 2015.
Croatian: Upravni odbor EMA-e donio je aktualnu verziju politike i postupka u slučaju zlouporabe povjerenja.
English: If a company wishes to request marketing authorisation in several EU Member States for a medicine that is outside the scope of the centralised procedure, it may use one of the following routes:
Croatian: • Nadležna nacionalna tijela (veterinarsko-medicinski proizvodi) Ako neka tvrtka namjerava zatražiti odobrenje za stavljanje u promet u nekoliko država članica EU-a za lijek koji je izvan područja primjene centraliziranog postupka, može to učiniti na jedan od sljedećih načina:
English: EMA also publishes a large amount of information in lay language about its work and about medicines.
Croatian: EMA također objavljuje veliku količinu informacija o svom radu i o lijekovima koje su razumljive i laicima.
English: • Search human medicines
Croatian: • Pretraživanje lijekova za ljude
English: • develop laws concerning medicines.
Croatian: • ne priprema zakone o lijekovima.
English: • paediatric procedures;
Croatian: • pedijatrijski zahvati;
English: • the mutual-recognition procedure, whereby a marketing authorisation granted in one Member
Croatian: • postupkom međusobnog priznavanja, pri čemu odobrenje za stavljanje u promet dodijeljeno u jednoj državi članici može biti priznato i u drugim državama EU-a;
English: These bodies are composed of European experts made available by national competent authorities of the EU Member States, which work closely with EMA in the European medicines regulatory network.
Croatian: Ova tijela čine europski stručnjaci koje ustupaju nadležna nacionalna tijela država članica EU-a, koja s EMA-om blisko surađuju u sklopu Europske regulatorne mreže za lijekove.
English: • two representatives of patients' organisations;
Croatian: • dva predstavnika organizacija bolesnika;
English: Scope of the centralised authorisation procedure
Croatian: Područje primjene centraliziranog postupka odobrenja
English: It is consulted on the rules of procedure and the membership of the Agency's committees.
Croatian: On sudjeluje u savjetovanjima o pravilima postupanja i članovima odborâ Agencije.
English: • National competent authorities (human)
Croatian: • Nadležna nacionalna tijela (lijekovi za humanu uporabu)
English: Breach-of-trust procedure
Croatian: Postupak u slučaju zlouporabe povjerenja
English: National governments or the health authorities of individual EU Member States develop guidelines for decisions regarding diagnosis, management, and treatment in specific areas of healthcare (sometimes known as clinical guidelines);
Croatian: Smjernice o odlukama u pogledu dijagnoze, upravljanja i liječenja u određenim područjima zdravstva (ponekad nazivane i kliničke smjernice) razvijaju vlade ili zdravstvene ustanove pojedinih država članica EU-a;
English: Management Board
Croatian: Upravni odbor
English: • develop treatment guidelines.
Croatian: • ne razvija smjernice za liječenje.
English: EMA has in place a breach-of-trust procedure, which sets out how the Agency deals with incorrect or incomplete DoIs by experts and committee members.
Croatian: EMA je uspostavila postupak u slučaju zlouporabe povjerenja kojim se utvrđuje postupanje Agencije u slučajevima kada stručnjaci ili članovi odbora predaju netočne ili nepotpune izjave o interesima.
English: For more information, see Health-technology-assessment bodies;
Croatian: Više informacija potražite pod Tijela za procjenu medicinskih tehnologija;
English: Pooling expertise
Croatian: Objedinjavanje stručnog znanja
English: Multinational assessment teams
Croatian: Višenacionalni timovi za procjenu
English: • suspected side effects reported with medicines;
Croatian: • moguće nuspojave zabilježene pri primjeni lijekova;
English: The European Commission also develops EU policies in the field of human or veterinary medicines and public health.
Croatian: Europska komisija priprema zakone EU-a o lijekovima, a donose ih Europski parlament i Vijeće Europske unije . Europska komisija također razvija politike EU-a u području lijekova za ljude ili životinje i javnog zdravlja.
English: EMA is involved in the assessment of certain categories of medical devices.
Croatian: U nekim slučajevima EMA-i se može obratiti za savjet u vezi s određenim kategorijama medicinskim proizvoda.
English: • orphan designation of medicines for rare diseases;
Croatian: • oznaka za rijetke bolesti na lijekovima za liječenje rijetkih bolesti);
English: • Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary The data requirements and standards governing the authorisation of medicines are the same in the EU, irrespective of the authorisation route.
Croatian: Zahtjevi u pogledu podataka i standardi koji se primjenjuju na odobravanje lijekova jednaki su u EU-u, bez obzira na postupak odobrenja.
English: Tthe Management Board revised its rules on how the Agency handles potential competing interests of staff members in October 2016.
Croatian: Upravni odbor revidirao je pravila o rješavanju mogućih suprotstavljenih interesa članova osoblja unutar Agencije.
English: • issue marketing authorisations.
Croatian: • ne izdaje odobrenja za stavljanje u promet.
English: For more information, see Medical devices.
Croatian: Za više informacija pogledajte Medicinski proizvodi;
English: • evaluate medical devices.
Croatian: • ne procjenjuje medicinske proizvode.
English: − diabetes;
Croatian: − dijabetesa;
English: These are available on the EMA website under Management Board members.
Croatian: Ona je dostupna na internetskim stranicama Agencije.
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 9 January 2017
Croatian: Datum prvog odobrenja: 20. travnja 2012 Datum posljednje obnove odobrenja: 9 siječanj 2017
English: This medicine should not be used by children or adolescents under 18 years.
Croatian: Ovaj lijek ne smiju koristiti djeca ili adolescenti mlađi od 18 godina.
English: Showering or washing
Croatian: Tuširanje ili pranje
English: The clinical significance of this is unknown.
Croatian: Klinički značaj toga nije poznat.
English: *Spontaneous reports
Croatian: *Spontana izvješća
English: Dosing as for adults (see sections 4.4 and 5.2).
Croatian: Doziranje je jednako kao i u odraslih osoba (vidjeti dijelove 4.4 i 5.2).
English: The safety and efficacy of SANCUSO in children aged 0 to 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka SANCUSO u djece u dobi od 0 do 18 godina nije još ustanovljena.
English: Plasma protein binding is approximately 65%.
Croatian: Vezanje na proteine plazme iznosi otprilike 65%.
English: Exposure to sunlight
Croatian: Izlaganje sunčevoj svjetlosti
English: You must talk to a doctor if you do not feel better or if you feel worse after the first day of chemotherapy.
Croatian: Obavezno se obratite liječniku ako se ne osjećate bolje ili ako se osjećate lošije nakon prvog dana kemoterapije.
English: Symptomatic treatment should be given.
Croatian: Potrebno je primijeniti simptomatsko liječenje.
English: Complete control by day is illustrated below.
Croatian: Potpuna kontrola po danu prikazana je u nastavku.
English: Granisetron distributes freely between plasma and red blood cells.
Croatian: Granizetron se slobodno distribuira između plazme i crvenih krvnih stanica.
English: The remainder of the dose is excreted as metabolites, with 49% in the urine and 34% in the faeces.
Croatian: Ostatak doze izlučuje se u obliku metabolita, od čega 49% u urinu i 34% u stolici.
English: Do not remove the transdermal patch from the sachet until you are ready to use it.
Croatian: Nemojte vaditi transdermalni flaster iz vrećice dok niste spremni upotrijebiti ga.
English: 78% of patients were white, with 12% Asian and 10% Hispanic/Latino.
Croatian: Sedamdeset osam posto bolesnika bili su bijelci, s 12% Azijaca i 10% Latinoamerikanaca.
English: - Contact with water during bathing or showering will not change the way SANCUSO works.
Croatian: - Dodir s vodom tijekom kupanja ili tuširanja neće promijeniti djelovanje lijeka SANCUSO.
English: These data help to clarify the mechanisms by which some of the ECG changes (particularly QT and QRS prolongation) associated with this class of substance can occur.
Croatian: Ti podaci pomažu pojasniti mehanizme kojima mogu nastati neke promjene EKG-a (naročito produženje QT i QRS intervala) povezane s tom skupinom tvari.
English: Other medicines and SANCUSO
Croatian: Drugi lijekovi i SANCUSO
English: Contents of the pack and other information What SANCUSO contains
Croatian: Sadržaj pakiranja i druge informacije Što SANCUSO sadrži
English: If you have forgotten to apply your transdermal patch at the right time, apply it as soon as you remember, and tell your doctor as soon as possible before your chemotherapy treatment.
Croatian: Ako ste zaboravili zalijepiti transdermalni flaster u pravo vrijeme, primijenite ga čim se sjetite i obavijestite liječnika što prije, prije početka kemoterapije.
English: Preclinical data did not reveal any special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, reproduktivne toksičnosti i genotoksičnosti.
English: There is no specific antidote for granisetron.
Croatian: Ne postoji specifični antidot za granizetron.
English: The most commonly reported adverse reaction in clinical studies was constipation, occurring in approximately 8.7% of patients.
Croatian: Najčešće prijavljena nuspojava u kliničkim ispitivanjima bila je konstipacija, koja je zabilježena u približno 8,7% bolesnika.
English: No dose adjustment is necessary.
Croatian: Nije potrebno prilagođavanje doze.
English: What SANCUSO is and what it is used for
Croatian: Što je SANCUSO i za što se koristi
English: The majority of adverse reactions were mild or moderate in severity.
Croatian: Većina nuspojava bila je blaga ili umjerena.
English: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands
Croatian: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, Nizozemska
English: Avoid these activities while wearing this transdermal patch.
Croatian: Izbjegavajte te aktivnosti dok nosite ovaj transdermalni flaster.
English: The used transdermal patch will still contain some granisetron and should be disposed of immediately as described in section 5.
Croatian: Iskorišteni transdermalni flaster još sadrži nešto granizetrona i treba ga odmah baciti kako je opisano u dijelu 5.
English: Talk to your doctor if you want to remove the patch before the end of your chemotherapy treatment course (up to 7 days).
Croatian: Razgovarajte sa svojim liječnikom ako želite ukloniti flaster prije kraja liječenja kemoterapijom (do 7 dana).
English: Used transdermal patches still contain active ingredients, which may be harmful to others.
Croatian: Iskorišteni transdermalni flasteri još uvijek sadrže djelatne tvari koje mogu biti štetne za druge.
English: - Do not cut the transdermal patch into smaller pieces.
Croatian: Nemojte rezati transdermalni flaster na manje komadiće.
English: Do not put SANCUSO on areas that have been treated with creams, oils, lotions, powders or other skin products that could keep the transdermal patch from sticking well to your skin.
Croatian: Nemojte stavljati SANCUSO na područja na koja ste nanijeli kreme, ulja, losione, pudere ili druge proizvode za kožu zbog kojih se transdermalni flaster ne bi dobro prilijepio za kožu.
English: Granisetron may be affected by direct natural or artificial sunlight, see section 5.3 for further information.
Croatian: Izravna prirodna ili umjetna sunčeva svjetlost može utjecati na granizetron, vidjeti dio 5.3 za više informacija.
English: What SANCUSO looks like and contents of the pack
Croatian: Kako SANCUSO izgleda i sadržaj pakiranja
English: 2132NP Hoofddorp The Netherlands Tel: +31 (0) 237200822
Croatian: Tel: +31 (0) 237200822
English: - The active substance is granisetron.
Croatian: - Djelatna tvar je granizetron.
English: After intravenous injection, approximately 12% of the dose is excreted unchanged in the urine of healthy subjects in 48 hours.
Croatian: Nakon intravenske primjene, približno 12% doze izlučuje se neizmijenjeno u urinu zdravih ispitanika nakon 48 sati.
English: Each transdermal patch is packaged in a heat-sealed sachet composed of polyester-coated paper/aluminium/LLDPE.
Croatian: Svaki transdermalni flaster pakiran je u toplinski zalijepljenoj vrećici sastavljenoj od papira/aluminija/LLDPE obloženog poliesterom.
English: This medicine may not work as well and/or may affect your skin if exposed to direct sunlight or the light from sunlamps or tanning beds.
Croatian: Ovaj lijek možda neće biti jednako djelotvoran i/ili može utjecati na Vašu kožu ako se izlažete izravnoj sunčevoj svjetlosti ili svjetlu UV-lampi ili solarija.
English: If you use more SANCUSO than you should, simply remove the extra patch(es) and contact your doctor.
Croatian: Ako primijenite više lijeka SANCUSO nego što ste trebali, jednostavno uklonite dodatni flaster ili dodatne flastere i obratite se svom liječniku.
English: Tell your doctor or nurse before using this treatment if any of the following applies to you: - if you have been told you have a heart disorder or disease - if you have pain in your stomach or your stomach is swollen - if you have problems with your kidneys or liver.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primijenite ovo liječenje ako se bilo što od sljedećeg odnosi na vas: - ako Vam je rečeno da imate tegobe sa srcem ili kakvu bolest srca, - ako osjećate bol ili oticanje trbuha - ako imate problema s bubrezima ili jetrom.
English: If you use more SANCUSO than you should
Croatian: Ako primijenite više lijeka SANCUSO nego što ste trebali
English: Skin reactions at the site of application, such as irritation, itching or redness are uncommon and may affect up to 1 in 100 people.
Croatian: Kožne reakcije na mjestu primjene, kao što su nadražaj, svrbež ili crvenilo su manje česte i mogu se javiti u do 1 na 100 osoba.
English: - if you are allergic to granisetron or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to any other anti-sickness medicines whose name ends in “setron” e.g. ondansetron.
Croatian: - ako ste alergični na granizetron ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.), - ako ste alergični na bilo koji drugi lijek protiv mučnine čiji naziv završava sa "zetron" npr.
English: If it does not, tell your doctor.
Croatian: Ako ne nestane, obratite se svom liječniku.