FrancophonIA/ELRC3.0 huggingface dataset:
English: Endemic areas are areas where the disease has been continuously present among the people who live there and where outbreaks or epidemics have occurred.
Croatian: Endemska područja su područja na kojima je ova bolest stalno prisutna među ljudima koji tamo žive i u kojima su zabilježena izbijanja bolesti ili epidemije.
English: Additional protection precautions
Croatian: Dodatne mjere zaštite
English: • a mild to high fever or acute disease.
Croatian: • imate blagu do visoku vrućicu ili akutnu bolest.
English: • There is visible evidence of contamination, such as a change in appearance.
Croatian: • ako postoje vidljivi znakovi kontaminacije, primjerice promjena izgleda sadržaja
English: • blueness of the tongue or lips
Croatian: • plava boja jezika ili usana
English: Before each injection, the reconstituted suspension should be gently swirled once again.
Croatian: Prije svake injekcije rekonstituiranu suspenziju treba još jednom nježno zavrtiti.
English: It contains versions of these 4 varieties of the virus that have been weakened so that they cannot cause the disease.
Croatian: Cjepivo sadrži inačice ta 4 tipa virusa koje su oslabljene tako da ne mogu uzrokovati bolest.
English: Dengvaxia is available in packs of 1 or 10.
Croatian: Dengvaxia je dostupna u pakiranjima od 1 ili 10 bočica.
English: After reconstitution, one dose (0.5 mL) contains:
Croatian: Nakon rekonstitucije jedna doza (0,5 ml) sadrži:
English: Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što Vi ili Vaše dijete primite cjepivo jer sadrži Vama važne podatke.
English: Younger children Children less than 9 years of age must not receive the vaccine.
Croatian: Djeca mlađa od 9 godina ne smiju primiti ovo cjepivo.
English: These figures may not be extrapolated to other regions with different seroprevalence and epidemiological situations.
Croatian: Te se vrijednosti ne mogu ekstrapolirati na druge regije s drugačijom seroprevalencijom i epidemiološkom situacijom.
English: Dengue is not transmitted directly from personto-person.
Croatian: Denga se ne prenosi izravno s jedne osobe na drugu.
English: • have a weak immune system (the body's natural defences).
Croatian: • ako imate oslabljen imunosni sustav (prirodni obrambeni sustav tijela).
English: Dengvaxia should not be used in children less than 9 years of age (see sections 4.8).
Croatian: Dengvaxia se ne smije primijeniti djeci mlađoj od 9 godina (vidjeti dio 4.8).
English: • Individuals with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function.
Croatian: • Osobe sa simptomatskom HIV infekcijom ili asimptomatskom HIV infekcijom praćenom dokazima narušene funkcije imunosnog sustava.
English: The virus from an infected person can spread to other people through mosquito bites for about 4 to 5 days (maximum 12 days) after the first symptoms appear.
Croatian: Virus se sa zaražene osobe može proširiti na druge ljude putem uboda komarca tijekom približno 4 do 5 dana (najviše 12 dana) nakon pojave prvih simptoma.
English: In paediatric population, fever has been observed with a higher frequency (very common) than in adults (common).
Croatian: U pedijatrijskoj je populaciji vrućica opažena učestalije (vrlo često) nego u odraslih (često).
English: Non-clinical safety data revealed no special risks for humans based on a repeated-dose toxicity including assessment of local tolerance, and a developmental and reproductive toxicology program.
Croatian: Neklinički podaci o sigurnosti ne ukazuju na poseban rizik za ljude na temelju ispitivanja toksičnosti ponovljenih doza, uključujući ocjenu lokalne podnošljivosti, te programa ispitivanja razvojne i reproduktivne toksičnosti.
English: Pack size of 1 or 10.
Croatian: Pakiranja od 1 ili 10.
English: Hospitalised and/or clinically severe dengue fever in long-term safety follow-up data
Croatian: Podaci o hospitalizaciji i/ili klinički teškom obliku denga groznice tijekom dugoročnog praćenja sigurnosti
English: The MAH shall ensure that in each Member State where Dengvaxia is marketed, all healthcare professionals who are expected to use Dengvaxia have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja dužan je osigurati da u svakoj državi članici u kojoj Dengvaxia bude stavljena na tržište svi zdravstveni radnici za koje se očekuje da će koristiti cjepivo Dengvaxia imaju pristup/dobiju sljedeći edukacijski paket:
English: • If you or your child miss a scheduled injection, your doctor will decide when to give the missed injection.
Croatian: • Ako Vi ili Vaše dijete propustite primiti dogovorenu injekciju, Vaš će liječnik odlučiti kada primijeniti propuštenu injekciju.
English: Procedures should be in place to prevent injury from falling and to manage syncopal reactions.
Croatian: Važno je da postoje utvrđene procedure za sprječavanje ozljeda pri padu i zbrinjavanje sinkopnih reakcija.
English: • skin eruption over the whole body (rash generalized)
Croatian: • kožna erupcija po cijelom tijelu (generalizirani osip)
English: 1541 avenue Marcel Mérieux 69280 Marcy l'Etoile France
Croatian: 1541 avenue Marcel Mérieux 69280 Marcy l'Etoile Francuska
English: A neurovirulence study shows that CYD dengue vaccine is not neurotoxic.
Croatian: Ispitivanje neurovirulencije pokazuje da CYD cjepivo protiv denge nije neurotoksično.
English: • medicines called “immunoglobulins” or blood products containing immuno globulins, such as blood or plasma.
Croatian: • lijekove koji se zovu ‘imunoglobulini' ili krvne pripravke koji sadrže imunoglobuline, kao što su krv ili plazma.
English: Serious allergic (anaphylactic) reactions
Croatian: Ozbiljne alergijske (anafilaktičke) reakcije
English: Instructions for preparing the vaccine intended for medical and healthcare professionals are included at the end of the leaflet.
Croatian: Upute za pripremu cjepiva namijenjene zdravstvenim radnicima nalaze se na kraju ove upute o lijeku.
English: These signs or symptoms (anaphylactic reactions) usually develop soon after the injection is given and while you or your child are still in the clinic or doctor's surgery.
Croatian: Ti se znakovi ili simptomi (anafilaktičke reakcije) obično javljaju ubrzo nakon primjene injekcije, dok ste Vi ili Vaše dijete još u ambulanti ili liječničkoj ordinaciji.
English: Vaccination should be preceded by a review of the individual's medical history (in particular, previous vaccinations and possible adverse reactions which occurred after vaccination).
Croatian: Cijepljenju treba prethoditi pregled osobne medicinske anamneze (osobito prethodnih cijepljenja i mogućih nuspojava koje su se javile nakon cijepljenja).
English: What Dengvaxia is and what it is used for
Croatian: Što je Dengvaxia i za što se koristi
English: The adverse reactions were usually mild to moderate in severity and of short duration (0 to 3 days).
Croatian: Nuspojave su obično bile blage do umjerene težine te kratkotrajne (0 - 3 dana).
English: It must not be injected into a blood vessel.
Croatian: Ne smije se injicirati u krvnu žilu.
English: Person-years: sum of time-at-risk (in years) for the subjects during the study period.
Croatian: Osoba-godina: ukupno vrijeme pod rizikom (u godinama) za ispitanike tijekom razdoblja ispitivanja.
English: These data are inconclusive due to the low number of cases in the immunogenicity subset.
Croatian: Na temelju tih podataka ne mogu se donijeti konačni zaključci zbog malog broja slučajeva u podskupini za ocjenu imunogenosti.
English: Any unused product or waste material should be disposed of in accordance with local regulations.
Croatian: Neiskorišteno cjepivo ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Dengvaxia stimulates the body's natural defences (immune system), to produces antibodies that will help protect against the viruses that cause dengue disease if the body is exposed to them in the future.
Croatian: Dengvaxia potiče prirodni obrambeni sustav tijela (imunosni sustav) da proizvede protutijela koja će ga zaštititi od virusa koji uzrokuju denga bolest ako im tijelo dođe u kontakt s tim virusima u budućnosti.
English: Urticaria (uncommon) was only reported in subjects 9 to 17 years of age (none in adults).
Croatian: Urtikarija (manje često) je prijavljena samo u ispitanika u dobi od 9 do 17 godina (ne i u odraslih).
English: • think you or your daughter may be pregnant or are planning to have a baby, ask your doctor,
Croatian: • ako mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku,
English: In particular, tell your doctor or pharmacist if you are taking any of the following:
Croatian: Osobito je važno da kažete liječniku ili ljekarniku ako uzimate bilo što od sljedećega:
English: Prior to launch of Dengvaxia in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja cjepiva Dengvaxia na tržište u svakoj državi članici nositelj odobrenja mora s nadležnim državnim tijelom usuglasiti sadržaj i oblik edukacijskog programa, uključujući način komunikacije i distribucije te sve ostale aspekte programa.
English: • Pregnant women (see section 4.6).
Croatian: • Trudnice (vidjeti dio 4.6).
English: Tell your doctor or pharmacist if you or your child are using, have recently used or might use any other vaccines or medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako Vi ili Vaše dijete primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje drugo cjepivo ili lijekove.
English: To avoid vaccination of false positives, only test methods with adequate performance in terms of specificity and cross-reactivity based on the local disease epidemiology should be used.
Croatian: Kako bi se izbjeglo cijepljenje osoba s lažno pozitivnim nalazima, smiju se koristiti samo metode testiranja odgovarajućih izvedbenih značajki u smislu specifičnosti i križne reaktivnosti na temelju lokalne epidemiologije bolesti.
English: N: number of subjects per study
Croatian: N: broj ispitanika po ispitivanju
English: Any remaining vaccine doses should be discarded at the end of the immunization session or within 6 hours after reconstitution, whichever comes first.
Croatian: Preostale doze cjepiva potrebno je baciti na kraju provedbe imunizacije ili po isteku 6 sati od rekonstitucije, što god se dogodi ranije.
English: Dengvaxia contains live attenuated viruses.
Croatian: Dengvaxia sadrži žive atenuirane viruse.
English: Contact with disinfectants is to be avoided since they may inactivate the vaccine viruses.
Croatian: Treba izbjegavati doticaj sa sredstvima za dezinfekciju jer ona mogu inaktivirati viruse u cjepivu.
English: No specific studies have been performed on fertility.
Croatian: Nisu provedena specifična ispitivanja učinaka na plodnost.
English: Pharmacotherapeutic group: Vaccines, Viral vaccines, ATC code: J07BX/ Not Yet assigned
Croatian: Farmakoterapijska skupina: Cjepiva, virusna cjepiva, ATK oznaka: J07BX/ nije još dodijeljena Mehanizam djelovanja
English: The powder and the solvent must be mixed together before use.
Croatian: Prašak i otapalo moraju se pomiješati prije primjene.
English: The Control Group in dengue studies was defined as subjects who received at least one injection of placebo or comparator vaccine.
Croatian: Kontrolna skupina u ispitivanjima denge definirala se kao ispitanici koji su primili najmanje jednu injekciju placeba ili usporednog cjepiva.
English: • infections of the nose or throat (upper respiratory tract)
Croatian: • infekcije nosa ili grla (gornjih dišnih putova)
English: Available data are not sufficient to confirm the safety and efficacy in individuals previously infected by any dengue virus and younger than 9 years.
Croatian: Dostupni podaci nisu dostatni da bi se potvrdile sigurnost i djelotvornost cjepiva u osoba mlađih od 9 godina koje su prethodno bile zaražene bilo kojim virusom denge.
English: Other medicines and Dengvaxia
Croatian: Drugi lijekovi i Dengvaxia
English: • sudden and serious feeling of illness or unease with drop in blood pressure causing dizziness and loss of consciousness, rapid heartbeat linked with breathing difficulty.
Croatian: • iznenadna i ozbiljna slabost ili nelagoda praćena padom krvnog tlaka koji uzrokuje omaglicu i gubitak svijesti, te ubrzane otkucaje srca povezane s otežanim disanjem.
English: • low blood pressure causing dizziness or fainting
Croatian: • nizak krvni tlak koji uzrokuje omaglicu ili nesvjesticu
English: Vaccination is not recommended if you live in area where dengue infections do not regularly occur and if you plan to travel to an area where dengue infections regularly occur.
Croatian: Cijepljenje se ne preporučuje ako živite u području gdje infekcije virusom denge nisu redovita pojava i planirate putovati u područje gdje su infekcije virusom denge česte.
English: The physician educational material should contain:
Croatian: Edukacijski materijali za liječnike moraju sadržavati:
English: Cases: number of subjects with at least one symptomatic virologically-confirmed dengue episode in the considered period.
Croatian: Slučajevi: broj ispitanika s najmanje jednom epizodom simptomatske virološki potvrđene denge u promatranom razdoblju.
English: The active detection of symptomatic dengue cases started on the day of the first injection and lasted until each subject had been followed for at least 13 months after the third injection.
Croatian: Aktivno otkrivanje slučajeva simptomatske denge započelo je na dan primjene prve injekcije, a trajalo je sve dok svaki ispitanik nije bio praćen najmanje 13 mjeseci nakon treće injekcije.
English: Read the package leaflet before use and for reconstitution instructions.
Croatian: Prije uporabe pročitajte uputu o lijeku i upute za rekonstituciju.
English: They can also happen very rarely after receiving any vaccine (may affect up to 1 in 10 000 people).
Croatian: Oni se vrlo rijetko mogu javiti i nakon primjene bilo kojeg drugog cjepiva (mogu se javiti u do 1 na 10 000 osoba).
English: The marketing authorisation holder (MAH) shall submit the first PSURs for this product within 6 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će prvi PSUR za ovaj lijek dostaviti unutar 6 mjeseci nakon dobivanja odobrenja.
English: It is used to help protect you or your child against "dengue disease" caused by dengue virus serotypes 1, 2, 3 and 4.
Croatian: Koristi se kako bi Vas ili Vaše dijete pomoglo zaštititi od „denga bolest” uzrokovane virusom denge serotipa 1, 2, 3 i 4.
English: The Guide for healthcare professionals shall contain the following key elements:
Croatian: • Vodič za zdravstvene radnike Vodič za zdravstvene radnike mora sadržavati sljedeće ključne elemente:
English: Very rare: (may affect up to 1 in 10 000 people) • allergic reactions.
Croatian: Vrlo rijetko: (mogu se javiti u do 1 na 10 000 osoba) • alergijske reakcije
English: For patients receiving treatment with immunoglobulins or blood products containing immunoglobulins, such as blood or plasma, it is recommended to wait for at least 6 weeks, and preferably for 3 months, following the end of treatment before administering Dengvaxia, in order to avoid neutralization of the attenuated viruses contained in the vaccine.
Croatian: U osoba koje se liječe imunoglobulinima ili krvnim pripravcima koji sadrže imunoglobuline, kao što su krv ili plazma, preporučuje se pričekati najmanje 6 tjedana, a po mogućnosti 3 mjeseca nakon završetka liječenja da bi se primijenila Dengvaxia, kako bi se izbjegla neutralizacija atenuiranih virusa sadržanih u cjepivu.
English: Signs of an allergic reaction may include an itchy rash, shortness of breath and swelling of the face and tongue.
Croatian: Znakovi alergijske reakcije mogu uključivati kožni osip koji svrbi, nedostatak zraka te oticanje lica i jezika.
English: Adverse reactions occurred within 3 days following vaccination except fever which appears within 14 days after the injection.
Croatian: Nuspojave su se javile unutar 3 dana nakon cijepljenja, osim vrućice, koja nastupa unutar 14 dana nakon injekcije.
English: * Adverse reactions from spontaneous reporting.
Croatian: *Spontano prijavljene nuspojave.
English: You should take precautions to prevent mosquito bites.
Croatian: Poduzmite mjere opreza za sprječavanje uboda komaraca.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2018
Croatian: Datum prvog odobrenja: 12.prosinac 2018.
English: It is recommended to continue personal protection measures against mosquito bites after vaccination.
Croatian: Preporučuje se nastaviti poduzimati osobne mjere zaštite od uboda komaraca i nakon cijepljenja.
English: The efficacy was assessed during an Active Phase of 25 months, in which surveillance was designed to maximize the detection of all symptomatic virologically-confirmed dengue (VCD) cases regardless of the severity.
Croatian: Djelotvornost se ocjenjivala tijekom 25-mjesečne aktivne faze, u kojoj je nadzor bio osmišljen tako da se maksimizira otkrivanje svih slučajeva simptomatske virološki potvrđene denge (engl. virologically confirmed dengue, VCD), neovisno o njihovoj težini.
English: • had an allergic reaction after using Dengvaxia before.
Croatian: • ako ste imali alergijsku reakciju nakon prethodne primjene cjepiva Dengvaxia.
English: Dengue is a viral infection which spreads through the bite of an infected Aedes mosquito.
Croatian: Denga je virusna infekcija koja se širi ubodom zaraženog komarca iz roda Aedes.
English: Clinically severe VCD cases†
Croatian: Klinički teški slučajevi VCD-a†
English: As there are no data on co-administration of Dengvaxia vaccine with other vaccines for the population from 9 years and above, the concomitant use of Dengvaxia with other vaccines is not recommended.
Croatian: Budući da nema podataka o istodobnoj primjeni cjepiva Dengvaxia i drugih cjepiva u populaciji osoba u dobi od 9 i više godina, ne preporučuje se istodobna primjena cjepiva Dengvaxia s drugim cjepivima.
English: Women of childbearing potential have to use effective contraception during at least one month after each dose (see section 4.6).
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom najmanje mjesec dana nakon svake doze (vidjeti dio 4.6).
English: A partially used multidose vial must be discarded immediately if:
Croatian: Djelomično iskorištene višedozne bočice moraju se baciti odmah:
English: Like all medicines, Dengvaxia can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Dengvaxia može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: Administration of Dengvaxia must be postponed in individuals suffering from moderate to severe febrile or acute disease.
Croatian: Primjena cjepiva Dengvaxia mora se odgoditi u osoba koje imaju umjerenu do tešku febrilnu ili akutnu bolest.
English: Higher titres post-injection 3 are associated with a lower risk of dengue disease and higher vaccine efficacy, although an immunological correlate of protection has not been established.
Croatian: Viši titri nakon 3. injekcije povezani su s manjim rizikom od denga bolesti i većom djelotvornošću cjepiva, premda nije utvrđen imunološki korelat zaštite.
English: pharmacist or nurse for advice before using Dengvaxia.
Croatian: ljekarniku ili medicinskoj sestri za savjet prije nego primite cjepivo Dengvaxia
English: These data are not sufficient to conclude on the absence of potential effects of Dengvaxia on pregnancy, embryo-foetal development, parturition and post-natal development.
Croatian: Ti podaci nisu dostatni za donošenje zaključka o nepostojanju mogućih učinaka cjepiva Dengvaxia na trudnoću, razvoj zametka i ploda,
English: Estimates from the long-term analysis suggest the onset of increased risk was mainly during the 3rd year following the first injection.
Croatian: Procjene iz analize dugoročnih podataka ukazuju na to da je pojava povećanog rizika uglavnom nastupila tijekom 3. godine nakon prve injekcije.
English: Symptomatic VCD Any serotype
Croatian: Simptomatski VCD Bilo koji serotip Serotip 1
English: Then, GMTs stabilize over the next 2 to 4 years and remain superior to pre-vaccination GMTs.
Croatian: stabilizira tijekom naredne 2 do 4 godine i ostaje superioran u odnosu na GMT prije cijepljenja.
English: Most of the side effects occurred within 3 days of having the injection of Dengvaxia.
Croatian: Većina nuspojava javila se unutar 3 dana od injekcije cjepiva Dengvaxia.
English: This phase includes therefore the primary endpoint observation period from 28 days after the third injection up to the end of the Active Phase.
Croatian: Stoga ova faza uključuje razdoblje promatranja za primarnu mjeru ishoda koje je trajalo od 28. dana nakon treće injekcije sve do završetka aktivne faze.
English: Dengvaxia is available in packs of 5 (vaccine and solvent vials provided in the same box).
Croatian: Dengvaxia je dostupna u pakiranjima od 5 (bočice s cjepivom i otapalom isporučuju se u istoj kutiji).
English: Animal studies did not indicate any harmful effects with respect to female fertility (see section 5.3).
Croatian: Ispitivanja na životinjama nisu ukazala ni na kakve štetne učinke na plodnost ženki (vidjeti dio 5.3).
English: During clinical development, immunogenicity data were collected in a total of approximately 5700 subjects 9 months to 60 years of age that received at least one injection of the vaccine.
Croatian: Tijekom kliničkog razvoja, podaci o imunogenosti prikupljali su se u sveukupno približno 5700 ispitanika u dobi od 9 mjeseci do 60 godina koji su primili najmanje jednu injekciju cjepiva.
English: Dengvaxia is a vaccine.
Croatian: Dengvaxia je cjepivo.
English: • ever fainted from an injection.
Croatian: • ako ste se ikada onesvijestili zbog injekcije.
English: There are no safety, immunogenicity or efficacy data to support vaccination of individuals living in non-endemic areas and travelling to endemic areas, therefore vaccination of these individuals is not recommended.
Croatian: Putnici Nema podataka o sigurnosti, imunogenosti ni djelotvornosti koji bi poduprli cijepljenje osoba koje ne žive u endemskim područjima, već putuju u takva područja, pa se cijepljenje tih osoba ne preporučuje.
English: The same information is also available on the following URL: http://qr.sanofi.com/dengvaxia
Croatian: Iste informacije možete pronaći i na sljedećoj mrežnoj stranici: http://qr.sanofi.com/dengvaxia
English: The estimations described above for a 6 year period are derived from data obtained in the pivotal clinical trials in countries with a particular dengue seroprevalence and epidemiological context.
Croatian: Gore navedene procjene za razdoblje od 6 godina utemeljene su na podacima prikupljenima u pivotalnim kliničkim ispitivanjima u zemljama sa specifičnom seroprevalencijom virusa denge i specifičnim epidemiološkim uvjetima.
English: • are of child-bearing age, you must use an effective method of contraception to avoid pregnancy for at least one month after each Dengvaxia dose.
Croatian: • u reproduktivnoj dobi, morate koristiti učinkovitu metodu kontracepcije kako biste izbjegli trudnoću tijekom najmanje mjesec dana nakon svake doze cjepiva Dengvaxia
English: †The efficacy against hospitalised and severe VCD was not a primary objective and cut-off thresholds to define statistical significance were not pre-specified.
Croatian: †Djelotvornost protiv VCD-a koji je zahtijevao hospitalizaciju i teškog oblika VCD-a nije bila primarni cilj, pa nisu unaprijed definirane granične vrijednosti za utvrđivanje statističke značajnosti.
English: The clinical efficacy of the vaccine is based on bridging of immunogenicity data (see below section 3.2).
Croatian: Klinička djelotvornost cjepiva utvrđena je posrednim zaključivanjem na temelju podataka o imunogenosti (vidjeti odlomak 3.2 u nastavku).
English: Travellers
Croatian: Putnici