FrancophonIA/ELRC3.0 huggingface dataset:
English: The information submitted to the Agency will be made public for all participants who make an intervention at the public hearing, with the exception of any personal contact details.2
Croatian: Informacije podnesene Agencije dostupne su svim sudionicima koji interveniraju na javnoj raspravi, osim podataka za kontakt.2
English: The hearings shall be held in accordance with the modalities specified by the Agency and shall be announced by means of the European medicines web-portal.
Croatian: Rasprava se organizira na način koji odredi Agencija i najavljuje se putem europskog portala za lijekove.
English: The value of a public hearing is considered to be greater in that phase of the process where the PRAC has assessed the scientific evidence coming from different sources and where different regulatory options to manage and/or minimise risks are to be considered in a wider public health context, before reaching its conclusion.
Croatian: Javna rasprava ima veću vrijednost u fazi postupka kada PRAC procjenjuje znanstvene dokaze iz različitih izvora i kada se razmatraju različite regulatorne opcije za upravljanje i/ili smanjenje rizika u širem kontekstu javnog zdravlja prije donošenja konačne odluke.
English: A record of the meeting, the list of speakers and all other participants, including their affiliation, their declared interests, any supporting documentation presented by speakers and a summary of the conclusions of the meeting will be made available following the public hearing on the Agency's website.
Croatian: Zapisnik sastanka, popis govornika i svih ostalih sudionika, uključujući njihovu povezanost i navedene interese te popratna dokumentacija koju su govornici izložili i sažetak zaključaka sastanaka bit će dostupni na internetskim stranicama Agencije nakon javne rasprave.
English: The Agency will prepare a list of speakers and a draft agenda for the public hearing, stating the time allocated to each group of speakers, grouped by capacity, and each speaker within a group.
Croatian: Agencija priprema popis govornika i nacrt dnevnog reda za javnu raspravu u kojem se navodi predviđeno vrijeme za svaku skupinu govornika grupiranih prema svojstvu i za svakog govornika posebno unutar skupine.
English: A public hearing is a forum to which the public is invited to express its views, guided by a pre-defined set of questions, on issues related to the safety of a particular medicinal product, a medicinal substance or a therapeutic class, whilst also considering the therapeutic effects of these products.
Croatian: Javna rasprava je forum na koji je javnost pozvana da, vođena kroz prethodno definirana pitanja, izrazi svoje mišljenje o pitanjima u vezi sa sigurnošću određenog lijeka, aktivne tvari ili terapijske klase, uzimajući pritom u obzir terapijske učinke tih proizvoda.
English: Participants are encouraged to use English during the public hearing.
Croatian: Sudionike se potiče da se koriste engleskim jezikom tijekom javne rasprave.
English: • Where space permits, requests to observe the public hearing in person without making an intervention will be accommodated.
Croatian: • Kada to prostor dozvoljava, odobrava se zahtjev za osobno prisustvovanje javnoj raspravi bez intervencije.
English: The Agency shall, in consultation with the parties concerned, draw up rules of procedure on the organisation and conduct of public hearings, in accordance with Article 78 of Regulation (EC) No
Croatian: Uz savjetovanje sa zainteresiranim strankama, Agencija donosi Poslovnik organizacije i provođenja javnih rasprava u skladu s člankom 78. Uredbe (EZ) br. 726/2004.
English: Requests for participation as an observer at the public hearing should also be sent to the Agency.
Croatian: Zahtjevi za prisustvovanje javnoj raspravi u svojstvu promatrača također se šalju Agenciji.
English: The marketing authorisation holder(s) has/have the opportunity to present its/their view(s) to the participants of the public hearing.
Croatian: Nositelj(i) odobrenja za stavljanje lijeka(ova) u promet ima(ju) priliku predstaviti svoje stajalište sudionicima javne rasprave.
English: • Feasibility to hold a public hearing in light of the urgency of the matter.
Croatian: • mogućnost organiziranja javne rasprave s obzirom na hitnost zahtjeva
English: Where time permits, the PRAC Chair can open the floor to all participants in the room, for additional statements on the points made during the hearing.
Croatian: Ako preostane dovoljno vremena, predsjednik PRAC-a može dati riječ svim sudionicima u prostoriji da izraze dodatna mišljenja o zaključcima donesenim tijekom rasprave.
English: If the allocated time ends before a speaker has concluded his or her intervention, the PRAC Chair should remind him or her to do so.
Croatian: Ako predviđeno vrijeme završi prije nego što govornici završe svoju intervenciju, predsjednik PRAC-a upozorava ih da je završe.
English: The assessment report will reference how the outcome of the public hearing has been addressed during the considerations at the level of the PRAC.
Croatian: U izvješću o ocjeni navodi se na koji je način ishod javne rasprave utjecao na razmatranja unutar PRAC-a.
English: Participants have to request this when they register to speak at the public hearing.
Croatian: Sudionici moraju to zatražiti prilikom prijave za izlaganje na javnoj raspravi.
English: Each speaker will be asked to briefly introduce himself or herself, clearly state their name and the organisation/group the speaker represents, where applicable, and to declare any interests related to the medicinal products/medicinal substances, including their competitors, discussed at the meeting.
Croatian: Svaki govornik se kratko predstavlja, navodi svoje ime i ako je primjenjivo naziv organizacije/skupine koju predstavlja te svoje interese u vezi s lijekovima / aktivnim tvarima, uključujući njihove konkurente, o kojima se raspravlja na sastanku.
English: All individuals admitted as speakers will receive confirmation in advance of the hearing.
Croatian: Sve osobe koje su odabrane kao govornici primit će potvrdu prije rasprave.
English: “Where the urgency of the matter permits, the Pharmacovigilance Risk Assessment Committee may hold public hearings, where it considers that this is appropriate on justified grounds particularly with regard to the extent and seriousness of the safety concern.
Croatian: „Kad hitnost zahtjeva to dozvoljava, Odbor za ocjenu rizika na području farmakovigilancije može organizirati javnu raspravu, kad smatra da je to primjereno zbog utemeljenih razloga posebno u pogledu opsega i ozbiljnosti sigurnosnog problema.
English: All members of the public who wish to attend the public hearing as a speaker should submit their request in advance of the meeting, by the deadline specified in the Agency's announcement of the public hearing.
Croatian: Svi članovi javnosti (pojedinci) koji žele prisustvovati javnoj raspravi kao govornici moraju podnijeti svoj zahtjev prije rasprave, do roka navedenog u najavi javne rasprave Agencije.
English: 1.4. Who can attend a public hearing
Croatian: Tko može prisustvovati javnoj raspravi
English: The PRAC Chair opens the public hearing.
Croatian: Predsjednik PRAC-a otvara javnu raspravu.
English: Modalities of participation
Croatian: Načini sudjelovanja
English: Supporting documentation presented by the speakers during the intervention will be published on the Agency's website following the public hearing.
Croatian: Popratna dokumentacija izlaganja govornika tijekom intervencije objavljuje se na internetskim stranicama Agencije nakon javne rasprave.
English: Modalities of participation in a public hearing therefore include the following:
Croatian: Stoga su mogući sljedeći načini sudjelovanja na javnoj raspravi:
English: Speakers will be alerted when their allocated time has nearly expired.
Croatian: Govornike se upozorava kad im ističe predviđeno vrijeme za izlaganje.
English: Concluding the hearing
Croatian: Završetak rasprave
English: Any requests by a marketing authorisation holder or another person to present in a non-public hearing data, considered confidential, relevant to the subject matter of the procedure should also be made at the time of submitting the request to participate.
Croatian: Zahtjevi nositelja odobrenja za stavljanje lijeka u promet ili drugih osoba za predstavljanje povjerljivih podataka relevantnih za predmet postupka na raspravi koja nije javna također se moraju podnijeti u vrijeme podnošenja zahtjeva za sudjelovanje.
English: • Information on the location of the public hearing.
Croatian: • informacije o mjestu održavanja javne rasprave
English: Further information is provided on the Agency's website under “Privacy statement”.
Croatian: Dodatne informacije potražite na internetskim stranicama Agencije u odjeljku Izjava o privatnosti.
English: Public hearings give the PRAC a channel to hear the public's views and concerns and take them into account in its opinion-making, particularly where options for regulatory actions to manage and/or minimise risks will need to be considered in a wider public health context.
Croatian: Kroz javne rasprave PRAC ima priliku saslušati mišljenja javnosti i te njeno viđenje problema te ih uzeti u obzir prilikom formiranja mišljenja, posebice u slučaju kada se pojedina regulatorna mjera za upravljanje i/ili smanjenje rizika razmatra u širem kontekstu javnog zdravlja.
English: At the end of the interventions the PRAC Chair summarises the interventions heard.
Croatian: Na kraju intervencija predsjednik PRAC-a daje sažetak saslušanih intervencija.
English: In the absence of the PRAC Chair, the PRAC Vice-Chair will chair the public hearing.
Croatian: U slučaju odsustva predsjednika PRAC-a javnim raspravama predsjeda potpredsjednik PRAC-a.
English: Different modalities of participation help to ensure that as many citizens as possible have access to the public hearing process.
Croatian: Različitim načinima sudjelovanja osigurava se pristup građana javnim raspravama u što većoj mjeri.
English: Detailed information on how to follow the broadcast will be made available via the Agency's website.
Croatian: Detaljne informacije o praćenju prijenosa objavljuju se na internetskim stranicama Agencije.
English: For organisational reasons, participants will be asked to register in advance.
Croatian: Iz organizacijskih razloga od sudionika se traži da se prijave unaprijed.
English: Different modalities of participation will help to ensure that as many citizens as possible have access to the public hearing.
Croatian: Različitim načinima sudjelovanja osigurava se mogućnost pristupa građana javnim raspravama u što većoj mjeri.
English: and will allocate time to each group, giving priority to civil society representatives, such as patients, consumers, healthcare professionals and academic research groups or organisations, particularly those relevant to the therapeutic area.
Croatian: Agencija grupira govornike prema njihovom svojstvu (vidjeti odjeljak 3.3.) i predviđa vrijeme za svaku skupinu, a prednost imaju predstavnici civilnog društva, poput bolesnika, potrošača, zdravstvenih radnika i akademskih istraživačkih skupina ili organizacija, posebice onih povezanih s terapijskim područjem.
English: At the start of each referral the PRAC will consider the need to hold a public hearing as described in section 2.2.
Croatian: Na početku svakog postupka PRAC razmatra potrebu za organiziranjem javne rasprave, kao što je opisano u odjeljku 2.2. Rano razmatranje potrebno je kako bi se ostavilo dovoljno vremena za organizaciju sastanka.
English: The public hearing will be chaired by the PRAC Chair.
Croatian: Javnim raspravama predsjeda predsjednik PRAC-a.
English: • The proceedings of the public hearing can also be observed via video broadcast on the Agency's website.
Croatian: • Postupke javne rasprave moguće je također pratiti na internetskim stranicama Agencije putem videoprijenosa.
English: The PRAC members may ask questions for clarification from the speaker once the speaker's intervention has finished.
Croatian: Nakon što govornik završi intervenciju, članovi PRAC-a mogu zatražiti dodatna razjašnjenja od govornika.
English: The decision to hold a public hearing is taken by the Committee on a case-by-case basis, depending on the urgency of the matter in question and on other justified grounds, particularly with regard to the extent and seriousness of the safety issue.
Croatian: Odbor donosi odluku o organizaciji javne rasprave za svaki slučaj posebno, uzimajući u obzir hitnost zahtjeva i sve ostale utemeljene razloge, posebno u pogledu opsega i ozbiljnosti sigurnosnog problema.
English: • General ground rules guiding the public hearing.
Croatian: • opća temeljna pravila provedbe javne rasprave
English: The order and time available for each intervention is determined in the agenda.
Croatian: U dnevnom redu određen je poredak i predviđeno vrijeme svake intervencije.
English: Submitting a request to attend as observer
Croatian: Podnošenje zahtjeva za prisustvovanje u svojstvu promatrača
English: These documents will be published in advance of the public hearing on the Agency's website.
Croatian: Ti se dokumenti objavljuju na internetskim stranicama Agencije prije javne rasprave.
English: Decision to hold a public hearing
Croatian: Odluka o organizaciji javne rasprave
English: The proceedings of the public hearing can also be followed via video broadcast on the Agency's website.
Croatian: Postupke javne rasprave također je moguće pratiti na internetskim stranicama Agencije putem videoprijenosa.
English: Requesters will receive a confirmation of their request in advance of the hearing.
Croatian: Prije rasprave podnositelji zahtjeva primit će potvrdu njihovog zahtjeva.
English: The information gathered in the public hearing will be taken into account during the considerations within the PRAC.
Croatian: PRAC tijekom svojeg razmatranja uzima u obzir informacije prikupljene na javnoj raspravi.
English: The Committee can reconsider its previous decision not to hold a public hearing during the course of the referral procedure, on the basis of new information.
Croatian: Odbor može tijekom trajanja postupaka procjene sigurnosti lijeka(ova), a na temelju novih informacija, ponovno razmotriti ranije donesenu odluku o neodržavanju javne rasprave.
English: Submitting a request to speak at the public hearing
Croatian: Podnošenje zahtjeva za izlaganje na javnoj raspravi
English: The Committee takes the decision to hold a public hearing on a case-by-case basis, where the urgency of the matter in question permits and after considering that this is appropriate on justified grounds particularly with regard to the extent and seriousness of the safety concern.
Croatian: Odbor donosi odluku o organiziranju javne rasprave za svaki predmet posebno, uzimajući u obzir hitnost zahtjeva uz utvrđivanje njene primjerenosti utemeljene na opravdanim razlozima, a posebno u pogledu opsega i ozbiljnosti sigurnosnog problema.
English: Evaluating the need for a public hearing
Croatian: Razmatranje potrebe za organizacijom javne rasprave
English: Opening statements
Croatian: 4.2. Uvodne izjave
English: The contributions made by the public during a public hearing will be considered by the PRAC.
Croatian: PRAC također uzima u obzir doprinose javnosti dobivene tijekom javne rasprave.
English: Anybody who has submitted a request to speak at the public hearing to the Agency and who has not been admitted
Croatian: Istovremeno se obavještavaju i sve osobe koje su Agenciji podnijele zahtjev za izlaganje na javnoj raspravi, a nisu odabrane uz obrazloženje zbog čega njihov zahtjev nije prihvaćen.
English: Conduct of a public hearing - during the hearing
Croatian: Provođenje javne rasprave - tijek rasprave
English: Follow-up to the public hearing
Croatian: Nastavno praćenje javne rasprave
English: Meeting records
Croatian: Zapisnici sastanka
English: The requests to speak at the public hearing will be reviewed by the Agency.
Croatian: Agencija razmatra zahtjeve za izlaganje na javnoj raspravi.
English: 3.5. Review of requests to speak at the public hearing
Croatian: Razmatranje zahtjeva za izlaganje na javnoj raspravi
English: The announcement of a public hearing is made in advance of the hearing.
Croatian: Javnu raspravu treba objaviti prije njenog održavanja.
English: The questions asked by the PRAC to be addressed during the hearing determine the target audience.
Croatian: Ciljna publika određuje se na temelju pitanja kojima se PRAC želi posvetiti tijekom rasprave.
English: Purpose of a public hearing
Croatian: 1.3. Svrha javne rasprave
English: Announcement of the public hearing
Croatian: Najava javne rasprave
English: The full EPAR for Cinryze can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Cinryze nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 01-2017.
Croatian: Ovaj sažetak je posljednji put ažuriran: 01. 2017.
English: What is Cinryze and what is it used for?
Croatian: Što je Cinryze i za što se koristi?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cinryze on 15 June 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Cinryze na snazi u Europskoj uniji od 15. lipnja 2011.
English: The main measure of effectiveness in this study was how long it took for the symptoms to start improving.
Croatian: Glavno mjerilo učinkovitosti u tom ispitivanju bilo je vrijeme proteklo do početka poboljšanja simptoma.
English: In addition, the company will maintain a patient registry to provide further data on long-term safety and the way the medicine is used in practice.
Croatian: Osim toga, tvrtka će voditi registar bolesnika kako bi se dobili daljnji podaci o dugoročnoj sigurnosti primjene i načinu kako se lijek primjenjuje u praksi.
English: What measures are being taken to ensure the safe and effective use of Cinryze?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cinryze?
English: This is a summary of the European public assessment report (EPAR) for Cinryze.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Cinryze.
English: Why has Cinryze been approved?
Croatian: Zašto je Cinryze odobren?
English: Other information about Cinryze
Croatian: Ostale informacije lijeku Cinryze
English: Two main studies involving children aged 6 to 11 years were also carried out.
Croatian: Provedena su i dva glavna ispitivanja u djece u dobi od 6 do 11 godina.
English: Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema.
Croatian: U bolesnika s niskim koncentracijama tog proteina, ta dva sustava prekomjerno su aktivna što rezultira pojavom simptoma angioedema.
English: The C1 inhibitor protein is required to control the ‘complement' and ‘contact' systems, collections of proteins in the blood that fight against infection and cause inflammation.
Croatian: Protein inhibitor C1 potreban je za kontrolu „komplementnog” i „kontaktnog” sustava, nakupina proteina u krvi koji se bore protiv infekcija i uzrokuju upalu.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Cinryze.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke za primjenu lijeka Cinryze.
English: A second dose of 1,000 Units may be given if the patient has not responded adequately after one hour, or sooner for attacks in the larynx (voice box) or if the start of the treatment had been delayed.
Croatian: Druga doza od 1000 jedinica može se dati ako bolesnik nije odgovarajuće reagirao na lijek nakon jednog sata, ili ranije u slučaju laringealnih napadaja (u području grkljana) ili u slučaju odgođenog početka liječenja.
English: The average number of attacks during 12 weeks of treatment with Cinryze was reduced compared with the period before Cinryze and the attacks were less severe, did not last as long and required less treatment.
Croatian: Prosječni broj napadaja tijekom 12 tjedana liječenja lijekom Cinryze bio je smanjen u usporedbi s razdobljem prije primjene lijeka Cinryze, napadaji su bili manje teški i nisu trajali dugo, a zahtijevali su manje liječenja.
English: For more information about treatment with Cinryze, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Cinryze pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: The patients chosen for the second study were those with frequent attacks, at least two attacks per month on average.
Croatian: Za drugo ispitivanje bili su odabrani ispitanici koji su imali česte napadaje, u prosjeku barem dva napadaja mjesečno.
English: Cinryze can only be obtained with a prescription.
Croatian: Cinryze se izdaje samo na recept.
English: The doctor should review the need for routine prevention on a regular basis and can adjust the frequency of the injections or the dose according to how the patient is responding.
Croatian: Liječnik treba redovito provjeravati postoji li potreba za rutinskom prevencijom i može prilagođavati učestalost injekcija ili dozu prema tome kako bolesnik reagira na liječenje.
English: Treatment should be started under the supervision of a doctor experienced in treating hereditary angioedema.
Croatian: Liječenje treba započeti pod nadzorom liječnika s iskustvom u liječenju nasljednog angioedema.
English: Patients with hereditary angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain.
Croatian: Bolesnici s nasljednim angioedemom imaju napadaje oticanja koji se mogu pojaviti na bilo kojem dijelu tijela, npr. na licu, udovima ili oko crijeva, što uzrokuju nelagodu i bol.
English: It is also used to prevent angioedema attacks that can be triggered by medical, dental or surgical procedures.
Croatian: Također se koristi za sprječavanje napadaja angioedema koji mogu biti izazvani medicinskim, stomatološkim ili kirurškim zahvatima.
English: What are the risks associated with Cinryze?
Croatian: Koji su rizici povezani s lijekom Cinryze?
English: Cinryze was effective in preventing attacks triggered by these procedures, with 98% of procedures not triggering an attack within 72 hours.
Croatian: Lijek Cinryze bio je učinkovit u prevenciji napadaja uzrokovanih tim zahvatima, pri čemu kod 98 % zahvata nije došlo do napadaja u razdoblju od 72 sata.
English: In children from 6 to 11 years of age the dose is reduced to 500 Units.
Croatian: U djece u dobi od 6 do 11 godina, doza je smanjena na 500 jedinica.
English: Cinryze is available as a powder and solvent that are made up into a solution for injection into a vein.
Croatian: Cinryze je dostupan je kao prašak i otapalo koji služe za pripremu otopine za injekciju u venu.
English: All the patients were given Cinryze and started having improvements 4 hours into treatment.
Croatian: Svi su bolesnici primili Cinryze, a poboljšanje su počeli osjećati nakon 4 sata.
English: The only common side effect seen in studies with Cinryze (seen in between 1 and 10 patients in 100) is rash, which is not serious and typically involves the arms, chest, abdomen or the injection site.
Croatian: Jedina česta nuspojava lijeka Cinryze zabilježena u ispitivanjima (zabilježena u 1 do 10 na 100 bolesnika) jest osip koji nije ozbiljan i uglavnom zahvaća ruke, prsni koš, trbuh ili mjesto primjene injekcije.
English: C1 inhibitor (human)
Croatian: Cinryze inhibitor C1 (ljudski)