FrancophonIA/ELRC3.0 huggingface dataset:
English: • precancerous lesions (growths) and cancers in the cervix, vulva or vagina and anus;
Croatian: • pretkancerogenih lezija (izraslina) i rak cerviksa, vulve ili vagine i anusa;
English: The full EPAR and risk management plan summary for Gardasil 9 can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Gardasil 9 nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses.
Croatian: Nakon cjepiva, imunosni sustav može brže proizvoditi protutijela nakon što je izložen stvarnim virusima.
English: There are more than 100 types of papillomavirus, some of which are associated with anogenital cancers in both men and women.
Croatian: Postoji više od 100 tipova papilomavirusa, od kojih su neki povezani s anogenitalnim vrstama raka u muškaraca i žena.
English: The proteins are assembled in ‘virus-like particles' (structures that look like HPV, so that the body can recognise them easily).
Croatian: Bjelančevine su skupljene u „čestice slične virusu” (strukture koje izgledaju poput HPV-a, tako da ih tijelo može lakše prepoznati).
English: The vaccine also contains an ‘adjuvant', a compound containing aluminium to stimulate a better response.
Croatian: Cjepivo također sadrži „adjuvans” (spoj koji sadrži aluminij) za poticanje boljeg odgovora.
English: The women were followed up for around three and a half years after the third dose of the vaccine.
Croatian: Žene su praćene tijekom razdoblja od tri i pol godine nakon treće doze cjepiva.
English: Gardasil 9 is given according to official recommendations.
Croatian: Gardasil 9 se primjenjuje u skladu sa službenim preporukama.
English: This is a summary of the European public assessment report (EPAR) for Gardasil 9.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Gardasil 9.
English: In studies, the most common side effects with Gardasil 9 (seen in more than 1 patient in 10) were reactions at the site of the injection (redness, pain and swelling) and headache.
Croatian: U ispitivanjima su najčešće nuspojave cjepiva Gardasil 9 (uočene kod više od 1 bolesnika na 10) bile reakcije u mjestu injekcije (crvenilo, bol i oticanje) i glavobolja.
English: The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh.
Croatian: Cjepivo se primjenjuje injekcijom u mišić, i to po mogućnosti u rame ili bedro.
English: All papillomaviruses have a shell, or ‘capsid', that is made up of proteins called ‘L1 proteins'.
Croatian: Svi papilomavirusi imaju ovojnicu ili „kapsidu”, koja je izgrađena od bjelančevina naziva „L1 proteini”.
English: It is recommended that individuals who receive the first dose of Gardasil 9 should complete the dosing regimen using this medicine.
Croatian: Preporuča se da pojedinci koji primaju prvu dozu lijeka Gardasil 9 završe potpuni režim doziranja primjenom ovog lijeka.
English: In Europe, approximately 90% of anal cancers, 15% of vulvar cancers, 70% of vaginal cancers, and 30 to 40% of penile cancers are estimated to be caused by HPV infection.
Croatian: Procjenjuje se kako je u Europi otprilike 90% raka anusa, 15% raka vulve, 70% vaginalnih vrsta raka i 30 do 40% raka penisa uzrokovano HPV-om.
English: Regarding side effects, although a large proportion of subjects develop injection site reactions, these are only slightly more than for Gardasil.
Croatian: Vezano uz nuspojave, iako je veliki broj subjekata razvio reakcije na mjestu injekcije, one su bile neznatno veće u odnosu na cjepivo Gardasil.
English: A further 5 HPV types (31, 33, 45, 52, and 58) also carry a high risk for developing cancer (they cause around 20% of cervical cancers).
Croatian: Daljnjih 5 tipova HPV-a (31, 33, 45, 52 i 58) može također prenositi rizik od nastanka raka (uzrokuju otprilike 20% raka cerviksa).
English: Patients who show signs of an allergy after a dose of Gardasil 9 (or of its precursor vaccines Gardasil or Silgard) should stop the vaccination course or should not receive Gardasil 9 at all.
Croatian: Bolesnici koji pokazuju znakove alergije nakon doze lijeka Gardasil 9 (ili na prekursore cjepiva Gardasil ili Silgard) trebaju prekinuti tijek cijepljenja ili uopće ne smiju primiti Gardasil 9.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Gardasil 9's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Gardasil 9 nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil 9 on 10 June 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Gardasil 9 na snazi u Europskoj uniji od 10. lipnja 2015.
English: human papillomavirus 9-valent vaccine (recombinant, adsorbed)
Croatian: 9-valentno cjepivo protiv humanog papilomavirusa (rekombinantno, adsorbirano)
English: There should always be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year.
Croatian: Između prve i druge doze mora uvijek proći najmanje jedan mjesec, te najmanje tri mjeseca između druge i treće doze, a sve se doze trebaju primijeniti unutar godine dana.
English: HPV types 16 and 18 cause a large majority of cervical and anal cancers, while HPV types 6 and 11 cause most of genital warts.
Croatian: Tipovi HPV-a 16 i 18 uzrokuju veliku većinu raka cerviksa i anusa, a tipovi HPV-a 6 i 11 uzrokuju većinu genitalnih bradavica.
English: The fifth main study involving 1,518 subjects compared the effect of a two-dose schedule of Gardasil 9 with a three-dose schedule.
Croatian: Peto glavno ispitivanje koje je obuhvatilo 1518 subjekata usporedilo je učinak rasporeda s dvije doze Gardasila 9 i s rasporedom s tri doze.
English: Why is Gardasil 9 approved?
Croatian: Zašto je Gardasil 9 odobren?
English: Gardasil 9 is a suspension for injection available in vials or prefilled syringes.
Croatian: Gardasil 9 je suspenzija za injekciju dostupna u ampulama ili napunjenim štrcaljkama.
English: Gardasil 9 can provide protection against all nine types of HPV infection, as seen in five main studies.
Croatian: Gardasil 9 može pružiti zaštitu od svih devet tipova infekcije HPV-om, kao što je to utvrđeno u pet glavnih ispitivanja.
English: What measures are being taken to ensure the safe and effective use of Gardasil 9?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Gardasil 9?
English: Gardasil 9 contains the purified L1 proteins for the nine HPV types above, produced by a method known as ‘recombinant DNA technology'.
Croatian: Gardasil 9 sadrži pročišćene L1 bjelančevine za devet prethodno navedenih tipova HPV-a koji se proizvode metodom poznatom pod nazivom „tehnologija rekombinantne DNK”.
English: The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 one month after the third dose.
Croatian: Glavna mjera djelotvornosti bio je razvoj protutijela protiv HPV-a tipova 6, 11, 16, 18, 31, 33, 45, 52 i 58 mjesec dana nakon treće doze.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Gardasil 9, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi za lijek Gardasil 9 nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: A risk management plan has been developed to ensure that Gardasil 9 is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Gardasil 9.
English: What is Gardasil 9 and what is it used for?
Croatian: Što je Gardasil 9 i za što se koristi?
English: This study found that Gardasil 9 stimulates similar levels of protection against all nine virus types in young men and women.
Croatian: Ispitivanjem je utvrđeno da Gardasil 9 stimulira slične razine zaštite protiv svih devet tipova virusa u mladih muškaraca i žena.
English: It is not intended to provide practical advice on how to use Gardasil 9.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Gardasil 9.
English: For a twodose schedule, the second dose should be given between five and thirteen months after the first dose.
Croatian: Kod rasporeda s dvije doze, druga se doza mora dati između pet i trinaest mjeseci nakon prve doze.
English: What are the risks associated with Gardasil 9?
Croatian: Koji su rizici povezani s lijekom Gardasil 9?
English: Nearly 100% of cervical cancers are caused by HPV infection.
Croatian: HPV infekcija uzrokuje gotovo 100% raka cerviksa.
English: Other information about Gardasil 9
Croatian: Ostale informacije o lijeku Gardasil 9
English: Gardasil 9 is normally given according to a either a two-dose schedule or a three-dose schedule for males and females from 9 to 14 years old and a three-dose schedule for males and females 15 years old and over.
Croatian: Gardasil 9 obično se daje prema rasporedu s dvije doze cjepiva ili rasporedu s tri doze cjepiva za muške i ženske osobe stare od 9 do 14 godina, te rasporedu s tri doze cjepiva za muške i ženske osobe u dobi i starije od 15 godina.
English: Thus Gardasil 9 is expected to prevent the majority of cervical, vaginal and vulvar cancers and premalignant lesions, as well as genital warts associated with HPV.
Croatian: Očekuje se da će cjepivo Gardasil 9 spriječiti većinu raka cerviksa, vagine i vulve te pretmaligne lezije kao i genitalne bradavice povezane sa HPV-om.
English: The first study looked at the effectiveness of Gardasil 9 in over 14,000 women aged between 16 and 26 years.
Croatian: Prvo je ispitivanje istražilo djelotvornost lijeka Gardasil 9 u više od 14 000 žena u dobi između 16 i 26 godina.
English: This study also showed that antibody levels against types 6, 11, 16 and 18 were adequate to protect against these four types of HPV infection.
Croatian: Tim je ispitivanjem također utvrđeno da su protutijela protiv tipova 6, 11, 16 i 18 bila primjerena za zaštitu protiv četiri tipa HPV infekcije.
English: For a three-dose schedule, the second dose should be given two months after the first and the third given four months after the second.
Croatian: Kod rasporeda s tri doze, druga se doza mora dati dva mjeseca nakon prve doze, a treća četiri mjeseca nakon druge.
English: For more information about treatment with Gardasil 9, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Gardasil 9 pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: It contains purified proteins from the nine types of HPV listed above.
Croatian: Sadrži pročišćene bjelančevine iz devet tipova prethodno navedenih HPV-ova.
English: The fourth main study compared the levels of antibodies against all nine HPV types one month after the third dose in around 1,419 young men aged 16 to 26 with those in 1,101 women aged 16 to 26.
Croatian: Četvrto glavno ispitivanje usporedilo je koncentracije protutijela protiv svih devet tipova HPV-a mjesec dana nakon treće doze kod 1419 mladih muškaraca u dobi od 16 do 26 godina s koncentracijama u 1101 žena u dobi od 16 do 26 godina.
English: The third study compared the effect of Gardasil 9 with the effect of Gardasil in 600 girls aged 9 to 15 years.
Croatian: Treće je ispitivanje usporedilo djelovanje lijeka Gardasil 9 s djelovanjem lijeka Gardasil u 600 djevojčica u dobi od 9 do 15 godina.
English: The study showed that the vaccine stimulates the production of adequate levels of antibodies against HPV of all nine types in girls and boys aged between nine and 15 years when compared with women 16-26 years of age, for whom protection against disease was demonstrated in the first study.
Croatian: Ispitivanjem je utvrđeno da cjepivo stimulira stvaranje primjerenih razina protutijela protiv HPV-a svih devet tipova u djevojčica i dječaka u dobi između devet i 15 godina u usporedbi s ženama u dobi od 16 do 26 godina, za koje je zaštita od bolesti dokazana u prvom ispitivanju.
English: How does Gardasil 9 work?
Croatian: Kako djeluje Gardasil 9?
English: This study looked at the development of antibodies one month after the last dose, and it showed that boys and girls given two doses of Gardasil 9 have similar levels of protection against all nine virus types to girls and women given three doses of Gardasil 9.
Croatian: U studiji je proučavan razvoj protutijela mjesec dana nakon zadnje doze, te se pokazalo da dječaci i djevojčice koji prime dvije doze cjepiva Gardasil 9 imaju iste razine zaštite od svih devet vrsta virusa kao i djevojčice i žene koje prime tri doze cjepiva Gardasil 9.
English: For the full list of all restrictions, see the package leaflet.
Croatian: Potpuni popis ograničenja potražite u uputi o lijeku.
English: Gardasil 9 is a vaccine used in males and females from the age of nine years to protect against the following conditions caused by nine types of the human papillomavirus (HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58):
Croatian: Gardasil 9 je cjepivo koje se primjenjuje u muškaraca i žena od 9 godina starosti i starijih za zaštitu od bolesti uzrokovanih s devet tipova humanog papilomavirusa (HPV tipovi 6, 11, 16, 18, 31, 33, 45, 52 i
English: For practical information about using Gardasil 9, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Gardasil 9 pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: The CHMP considered that Gardasil 9 offers a broader protection against cancer than its precursor Gardasil, since it protects against additional 5 new types of HPV (31, 33, 45, 52 and 58), which although less common than types 16 and 18, are also considered high-risk HPV types.
Croatian: CHMP je zaključio da Gardasil 9 nudi širi spektar zaštite protiv raka u odnosu na prekursor Gardasil, budući da štiti protiv dodatnih 5 novih tipova HPV-a (31, 33, 45, 52 i 58), koji se također smatraju HPV tipovima visokog rizika, iako su manje uobičajeni od tipova 16 i 18.
English: The study looked at the development of antibodies one month after the third dose, and it showed that girls vaccinated with Gardasil 9 have similar levels of protection against types 6, 11, 16 and 18 as girls vaccinated with Gardasil.
Croatian: Ispitivanje je istražilo razvoj protutijela mjesec dana nakon treće doze, i utvrđeno je da su djevojčice cijepljene cjepivom Gardasil 9 imale slične razine zaštite protiv tipova 6, 11, 16 i 18 kao djevojčice cijepljene cjepivom Gardasil.
English: The second study in 3066 subjects compared the effect of Gardasil 9 in girls and boys aged nine to 15 years with the effect of Gardasil 9 in young women aged 16 to 26 years.
Croatian: Drugo ispitivanje provedeno koje je obuhvatilo 3066 subjekata usporedilo je djelovanje cjepiva Gardasil 9 kod djevojčica i dječaka u dobi od devet do 15 godina s djelovanjem cjepiva Gardasil 9 u mladih žena u dobi od 16 do 26 godina.
English: This study showed that 1 out of 6,016 women vaccinated with 3 doses of Gardasil 9 developed disease related to HPV types 31, 33, 45, 52 and 58, compared with 30 out of 6,017 women vaccinated with 3 doses of Gardasil.
Croatian: To je ispitivanje pokazalo da se kod 1 od 6016 žena cijepljenih s 3 doze cjepiva Gardasil 9 razvila bolest povezana s tipovima HPV-a 31, 33, 45, 52 i 58, u usporedbi s 30 od 6017 žena cijepljenih s 3 doze cjepiva Gardasil.
English: The study looked at how many women given Gardasil 9 developed disease (growths or cancer) due to HPV infection caused by HPV types 31, 33, 45, 52 and 58 when compared with Gardasil vaccine (a previously approved vaccine which protects against types 6, 11, 16 and 18).
Croatian: Ispitivanje je istražilo kod kojeg broja žena koje su primile lijek Gardasil 9 se razvila bolest (bradavice ili rak) zbog infekcije HPV-om uzrokovane tipovima HPV-a 31, 33, 45,52 i 58 u usporedbi s cjepivom Gardasil (prethodno odobreno cjepivo koje štiti od tipova 6, 11, 16 i 18).
English: What benefits of Gardasil 9 have been shown in studies?
Croatian: Koje su koristi lijeka Gardasil 9 utvrđene u ispitivanjima?
English: For the full list of all side effects reported with Gardasil 9, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Gardasil 9 potražite u uputi o lijeku.
English: The protocol shall be submitted in accordance with Article 107n (1) of Directive 2001/83/EC:
Croatian: Protokol će biti dostavljen u skladu sa člankom 107n (1.) Direktive 2001/83/EZ:
English: The study should be conducted in more than one Member State.
Croatian: Ispitivanje treba provesti u više od jedne države članice.
English: Further interim reports should be submitted to the PRAC 6-monthly thereafter for the first 2 years.
Croatian: Daljnja privremena izvješća trebaju se dostaviti PRAC-u svakih 6 mjeseci tijekom prve 2 godine.
English: The final study report shall be submitted to the PRAC:
Croatian: Konačno završno izvješće dostavit će se PRAC-u:
English: The first interim report shall be submitted to the PRAC :
Croatian: Prvo privremeno izvješće dostavit će se PRAC-u:
English: National competent authorities of Member State(s) or reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nadležna državna tijela države(a) članice(a) ili referentne(ih) države(a) članice(a), gdje je to primjenjivo, osigurati će ispunjavanje sljedećih uvjeta od strane nositelja odobrenja:
English: These should be submitted to the National Competent Authorities: By 12 January 2015
Croatian: Do 12. siječnja 2015.
English: Within 6 months of the Coordination group agreement.
Croatian: U roku od 6 mjeseci u dogovoru s
English: The Marketing Authorisation Holders of valproate and related substances shall develop and submit educational materials according to agreed core elements.
Croatian: Nositelji odobrenja za stavljanje u promet lijeka valproat i povezanih tvari razvit i dostavit će edukacijske materijale sukladno dogovorenim ključnim elementima.
English: The study design should aim to evaluate and quantify the effectiveness of the risk minimisation measures, and should include a pre- and postimplementation analysis and assessment.
Croatian: Cilj dizajna ispitivanja treba biti ocjena i kvantificiranje djelotvornosti mjera za smanjivanje rizika, te isti treba uključivati analizu i ocjenu prije i nakon implementacije.
English: The Marketing Authorisation Holders of valproate and related substances shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to further characterise the prescribing patterns for valproate.
Croatian: Nositelji odobrenja za stavljanje u promet lijeka valproat i povezanih tvari provest će ispitivanje iskoristivosti lijeka kako bi ocijenili djelotvornost mjera za smanjivanje rizika i dalje okarakterizirali obrasce propisivanja za valproat.
English: These materials should ensure that prescriber are informed and the patients understand and acknowledge the risks associated with valproate in utero exposure.
Croatian: Ovi materijali trebaju osigurati informiranost propisivača te razumijevanje i prepoznavanje od strane bolesnika rizika povezanih s in-utero izlaganju valproatu.
English: Annex IV Conditions to the marketing authorisations
Croatian: Dodatak IV.
English: Concentrate for solution for intraocular irrigation
Croatian: Koncentrat za otopinu za intraokularno ispiranje
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Croatian: Broj EU odobrenja (Zaštićeno) ime Jačina
English: 10 (1 x 10) vial (multipack)
Croatian: Intraokularna primjena bočica (staklena) 10 (1 x 10) bočica (višestruko pakiranje)
English: Page 2/2
Croatian: Stanica 2/2
English: 28 March 2014
Croatian: 28. ožujka 2014.
English: Committee for medicinal products for veterinary use (CVMP)
Croatian: Povjerenstvo za veterinarsko-medicinske proizvode (CVMP)
English: International non-proprietary name (INN): barium selenate
Croatian: Međunarodni nezaštićeni naziv (INN): barij selenat
English: The re-examination procedure started on 11 June 2013.
Croatian: Postupak ponovnog pregleda započet je dana 11. lipnja 2013.
English: The referral started on 15 September 2011.
Croatian: Postupak upućivanja započet je 15. rujna 2011.
English: EMA/197955/2014 Veterinary Medicines
Croatian: EMA/197955/2014
English: On 23 August 2013, the European Commission requested the CVMP to review its opinion, mainly to clarify some aspects related to consumer risk assessment.
Croatian: Dana 23. kolovoza 2013., Europska je komisija zatražila od CVMP-a da pregleda svoje mišljenje, uglavnom kako bi pojasnio određene aspekte povezane s ocjenom rizika za potrošače.
English: The revised opinion was converted into a Decision by the European Commission on 28 March 2014.
Croatian: Dana 28. ožujka 2014. godine Europska komisija je preinačila revidirano mišljenje u Odluku.
English: During its meeting of 14-16 May 2013 the CVMP appointed K. Törneke as rapporteur and K. Baptiste as co-rapporteur for the re-examination procedure.
Croatian: Tijekom sastanka održanog od 14. - 16. svibnja 2013. godine, CVMP je imenovao K. Törnekea kao izvjestitelja i K. Baptistea kao pomoćnog izvjestitelja za postupak ponovnog pregleda.
English: Written explanations were provided by the applicants and marketing authorisation holders on 14 November 2011 and on 30 November 2012.
Croatian: Podnositelji zahtjeva i nositelji odobrenja za stavljanje VMP-a u promet dostavili su dana 14. studenog 2011. i 30. studenog 2012. pisana pojašnjenja.
English: The consolidated detailed grounds for the re-examination were submitted by Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) on 10 June 2013.
Croatian: Konsolidirani detaljni razlozi za ponovni pregled dostavljeni su od strane tvrtki Cross Vetpharm Group Limited i Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) dana 10. lipnja 2013.
English: On 26 April 2013, Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) notified the Agency of their intention to request a reexamination of the CVMP opinion of 10 April 2013.
Croatian: Dana 26. travnja 2013., Cross Vetpharm Group Limited i Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) obavijestili su Agenciju o svojoj namjeri da zatraže ponovno ispitivanje mišljenja CVMP-a od dana 10. travnja 2013. godine.
English: Opinion following an Article 350F referral for long-acting formulations for injection containing barium selenate for all food producing species EMA/197955/2014
Croatian: Mišljenje nakon provedenog postupka upućivanja sukladno članku 35.0F za dugodjelujuće formulacije za injekcije koje sadrže barijev selenat za sve vrste koje se koriste u proizvodnji hrane EMA/197955/2014