FrancophonIA/ELRC3.0 huggingface dataset:
English: Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal
Croatian: Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo 2734 503 Barcarena Portugal
English: Janssen Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena Portugal
Croatian: Farmacêutica Portugal, Lda Estrada Consiglieri Pedroso, 69 A, Queluz de Baixo2734 503 Barcarena Portugal
English: Janssen-Cilag Limited 50-100 Holmers Farm Way
Croatian: 50-100 Holmers Farm Way
English: Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium
Croatian: Janssen-Cilag NV Antwerpseweg 15-17 B-2340 Beerse Belgium
English: Vorgartenstraße 206B
Croatian: Janssen-Cilag Pharma GmbH Vorgartenstraße 206B
English: (cannot be estimated from the available data)
Croatian: (ne može se procijeniti iz dostupnih podataka)
English: This results in protection against the disease.
Croatian: To rezultira zaštitom od bolesti.
English: The potential risk for pregnant women is unknown.
Croatian: Potencijalan rizik za trudnice nije poznat.
English: Date of latest renewal: 18 September 2017
Croatian: Datum posljednje obnove odobrenja: 18. rujna 2017.
English: These symptoms have been of mild and transient nature)
Croatian: Ti su simptomi bili blage i prolazne prirode.)
English: Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture.
Croatian: Kanamicin se koristi u ranom procesu proizvodnje i uklanja se tijekom kasnijih stadija proizvodnje.
English: Immunogenicity in special populations
Croatian: Imunogenost u posebnim populacijama
English: Ask your doctor or nurse how to throw away medicines you no longer use.
Croatian: Pitajte svog liječnika ili medicinsku sestru kako baciti lijekove koje više ne koristite.
English: - if your child was born prematurely (before or at 28 weeks of pregnancy), particularly if they had breathing difficulties.
Croatian: - ako je Vaše dijete bilo prijevremeno rođeno (u 28 tjednu trudnoće ili ranije), posebice ako je imalo problema s disanjem.
English: The vaccine works by specifically stimulating the body's natural defense system of the vaccinated person.
Croatian: Cjepivo djeluje tako da specifično stimulira prirodni tjelesni obrambeni sustav cijepljene osobe.
English: See section 5.1.
Croatian: (vidjeti dio 5.1).
English: Pack sizes of 1 or 10 syringes.
Croatian: Pakiranja od 1 ili 10 štrcaljki.
English: 2, 3, 4, 12 months
Croatian: 2, 3, 4, 12 mjeseci
English: Intervals between Primary Doses
Croatian: Intervali između primarnih doza
English: Information on the safety of the vaccine to women and their children during breast-feeding is not available.
Croatian: Podaci o sigurnosti cjepiva za žene i njihovu djecu tijekom dojenja nisu dostupni.
English: Before use, the pre-filled syringe should be well shaken in order to form a homogeneous suspension.
Croatian: Prije upotrebe, napunjenu štrcaljku treba dobro protresti da nastane homogena suspenzija.
English: 1 month after 2nd dose
Croatian: 1 mjesec nakon 2. doze
English: Contents of the pack and other information What Bexsero contains
Croatian: Sadržaj pakiranja i druge informacije Što Bexsero sadrži
English: Most of the primary immunogenicity studies were conducted as randomized, controlled, multicenter, clinical trials.
Croatian: Većina primarnih ispitivanja imunogenosti provedena su kao randomizirana, kontrolirana, multicentrična klinička ispitivanja.
English: Adults above 50 years of age
Croatian: Odrasli stariji od 50 godina
English: The safety and efficacy of Bexsero in infants less than 8 weeks of age has not yet been established.
Croatian: Sigurnost i djelotvornost Bexsera u dojenčadi mlađe od 8 tjedana nisu još ustanovljene.
English: For adsorbent see section 2.
Croatian: Za adsorbens, vidjeti dio 2.
English: Non-clinical data reveal no special hazard for humans based on repeated dose toxicity and reproductive and developmental toxicity studies.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja toksičnosti ponovljenih doza, reproduktivne i razvojne toksičnosti.
English: The clinical significance of this observation and the need for additional booster doses to maintain longer term protective immunity has not been established.
Croatian: Klinički značaj tog zapažanja i potreba za dodatnim booster dozama radi održavanja dugotrajnijeg zaštitnog imuniteta nije ustanovljena.
English: Not less than 1 month
Croatian: Ne manje od 1 mjeseca
English: Tell your doctor or nurse if you or your child are taking, have recently taken, or might take any other medicines, or have recently received any other vaccine.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako Vi ili Vaše dijete uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove ili ste nedavno primili bilo koje drugo cjepivo.
English: See section 5.1 for information on protection against specific group B strains.
Croatian: Vidjeti dio 5.1 za informacije o zaštiti od specifičnih sojeva grupe B.
English: Bexsero has no or negligible influence on the ability to drive and use machines.
Croatian: Bexsero ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Other medicines and Bexsero
Croatian: Drugi lijekovi i Bexsero
English: Not less than 2 months
Croatian: Ne manje od 2 mjeseca
English: Your doctor or nurse may ask you to give your child medicines that lower fever at the time and after Bexsero has been given.
Croatian: Vaš liječnik ili medicinska sestra možda će Vas zatražiti da svojem djetetu dajete lijekove koji snižavaju vrućicu u vrijeme i nakon primanja Bexsera.
English: The tip cap of the syringe may contain natural rubber latex.
Croatian: Zatvarač vrha štrcaljke može sadržavati prirodnu lateks gumu.
English: The following side effects may also occur after receiving this vaccine.
Croatian: Sljedeće nuspojave također se mogu često pojavljivati nakon primanja ovog cjepiva.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Primjena s drugim cjepivima
English: Ask your doctor for advice whether it is beneficial for you to receive Bexsero.
Croatian: Upitajte svojeg liječnika za savjet je li za Vas primjena Bexsera korisna.
English: - If you or your child are allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6).
Croatian: - ako ste Vi ili Vaše dijete alergični na djelatne tvari ili neki drugi sastojak ovog cjepiva (naveden u dijelu 6).
English: If present, the kanamycin level in the vaccine is low.
Croatian: Ako je prisutan, razina kanamicina u cjepivu je niska.
English: The suspension is white opalescent liquid.
Croatian: Suspenzija je bijela opalescentna tekućina.
English: This will help to reduce some of the side effects of Bexsero.
Croatian: To će pomoći u smanjenju nekih nuspojava Bexsera.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Croatian: Kako je korist od cijepljenja u toj grupi dojenčadi velika, cijepljenje se ne smije uskratiti niti odgađati.
English: Antipyretic medication should be initiated according to local guidelines in infants and children (less than 2 years of age).
Croatian: Antipiretici se moraju primijeniti u skladu s lokalnim smjernicama u dojenčadi i djece (mlađe od 2 godine).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Bexsero is given.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite Bexsero.
English: Insufficient clinical data on exposed pregnancies are available.
Croatian: Dostupni klinički podaci o izloženim trudnoćama su oskudni.
English: If present, kanamycin levels in the final vaccine are less than 0.01 micrograms per dose.
Croatian: Ako su prisutne, razine kanamicina su u završnom cjepivu niže od 0,01 mikrograma po dozi.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Croatian: • Službeno puštanje serije lijeka u promet Sukladno članku 114 Direktive 2001/83/EZ, službeno puštanje serije lijeka u promet preuzet će državni laboratorij ili laboratorij određen za tu svrhu.
English: Experience of overdose is limited.
Croatian: Postoji ograničeno iskustvo s predoziranjem.
English: However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination.
Croatian: No, prisutnost manje infekcije, primjerice prehlade, ne smije rezultirati odgađanjem cijepljenja.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Croatian: Kao i kod svih injekcijskih cjepiva, odgovarajuće medicinsko liječenje i nadzor trebaju uvijek biti odmah dostupni u slučaju anafilaktičkog događaja nakon primjene cjepiva.
English: If you or your child have weakened immunity (for example, due to the use of immunosuppressive medications, or HIV infection, or hereditary defects of the body's natural defence system), it is possible that the effectiveness of Bexsero is reduced.
Croatian: Ako Vi ili Vaše dijete imate oslabljeni imunitet (primjerice, zbog upotrebe imunosupresivnih lijekova ili infekcije HIV-om ili nasljednih oštećenja prirodnog tjelesnog obrambenog sustava), moguće je da je učinkovitost cjepiva Bexsero smanjena.
English: The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe.
Croatian: Cjepivo se ne smije injicirati intravenski, supkutano ili intradermalno i ne smije se miješati s drugim cjepivima u istoj štrcaljki.
English: Bexsero contains sodium chloride
Croatian: Bexsero sadrži natrijev klorid
English: Overall, 78% (95% confidence limits from 63-90%) of the approximately 1,000 strains were potentially susceptible to vaccine-induced antibodies.
Croatian: Ukupno 78% (95%-tni interval pouzdanosti od 63-90%) od približno 1000 sojeva potencijalno su osjetljivi na protutijela inducirana cjepivom.
English: Among Bexsero recipients, 6837 were infants and children (less than 2 years of age), 1051 were children (2 to 10 years of age) and 2677 were adolescents and adults.
Croatian: Od primatelja Bexsera, njih 6837 bili su dojenčad i djeca (mlađa od 2 godine), 1051 djeca (u dobi od 2 do 10 godina), a 2677 adolescenti i odrasli.
English: Feeling faint or fainting.
Croatian: Osjećaj nesvjestice ili nesvjestica.
English: Your doctor may still recommend that you receive Bexsero if you are at risk of exposure to meningococcal infection.
Croatian: Liječnik ipak može preporučiti da primite Bexsero ako postoji rizik izloženosti meningokoknoj infekciji.
English: 0, 1 months
Croatian: 0, 1 mjesec
English: Of the subjects who received primary infant series of Bexsero, 3285 received a booster dose in the second year of life.
Croatian: Od ispitanika koji su primili primarnu seriju Bexsera za dojenčad, 3285 ih je primilo booster dozu u drugoj godini života.
English: If two needles of different lengths are provided in the pack, choose the appropriate needle to ensure an intramuscular administration.
Croatian: Ako se u pakiranju nalaze dvije igle različitih duljina, odaberite odgovarajuću iglu koja će osigurati intramuskularnu primjenu.
English: A survey of approximately 1,000 different invasive meningococcal group B isolates collected during 2007-2008 in 5 European countries showed that, depending on the country of origin, between 73% and 87% of meningococcal group B isolates had an appropriate MATS antigen profile to be covered by the vaccine.
Croatian: Pregled približno 1000 različitih izolata invazivne meningokokne grupe B prikupljenih tijekom 2007.-2008. u 5 europskih zemalja pokazao je da, ovisno od zemlje porijekla, između 73% i 87% izolata meningokokne grupe B ima odgovarajući MATS antigenski profil kojeg pokriva cjepivo.
English: When fever occurred, it generally followed a predictable pattern, with the majority resolving by the day after vaccination.
Croatian: Kada se pojavila vrućica, uglavnom je imala predvidljiv tijek, s većinom izlječenja jedan dan nakon cijepljenja.
English: This vaccine should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.
Croatian: Ovo cjepivo ne treba primjenjivati u osoba s trombocitopenijom ili bilo kojim poremećajem koagulacije zbog kojeg bi bila kontraindicirana intramuskularna injekcija, osim ako moguća korist jasno nadilazi rizik od primjene.
English: There are limited data on the use of Bexsero in patients with chronic medical conditions or with weakened immunity.
Croatian: Postoje ograničeni podaci o primjeni Bexsera u bolesnika s kroničnim medicinskim stanjima ili s oslabljenim imunitetom.
English: Immunogenicity data are available in individuals with complement deficiencies, asplenia, or splenic dysfunctions (see section 5.1).
Croatian: Dostupni su podaci o imunogenosti u osoba s nedostacima komplementa, asplenijom ili poremećajima funkcije slezene (vidjeti dio 5.1).
English: As with many vaccines, healthcare professionals should be aware that a temperature elevation may occur following vaccination of infants and children (less than 2 years of age).
Croatian: Kao i s mnogim cjepivima, zdravstveni radnici moraju biti svjesni da nakon cijepljenja dojenčadi i djece (mlađe od 2 godine) može uslijediti povišenje temperature.
English: Adsorbed on aluminium hydroxide (0.5 mg Al³+).
Croatian: Adsorbirano na aluminijevu hidroksidu (0,5 mg Al3+).
English: The effect of antipyretics other than paracetamol on the immune response has not been studied.
Croatian: Djelovanje drugih antipiretika osim paracetamola na imunološki odgovor nije ispitivano.
English: There are no data on fertility in humans.
Croatian: Ne postoje podaci o utjecaju na plodnost u ljudi.
English: There were no effects on female fertility in animal studies.
Croatian: Ne postoje učinci na plodnost ženki u ispitivanjima na životinjama.
English: The benefit-risk ratio must be examined before making the decision to immunise during breast-feeding.
Croatian: Omjer koristi/rizika mora se istražiti prije donošenja odluke o imunizaciji tijekom dojenja.
English: - if you or your child receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab.
Croatian: - ako Vi ili Vaše dijete primate terapiju koja blokira dio imunološkog sustava koji se naziva aktivacija komplementa, primjerice ekulizumab.
English: Name and address of the manufacturers of the biological active substance (OMV):
Croatian: Naziv i adresa proizvođača biološke djelatne tvari (OMV):
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Croatian: Potencijalni rizik od apneje i potreba za respiratornim nadzorom tijekom 48 do 72 sata moraju se uzeti u obzir kada se primjenjuje primarna imunizacijska serija na nedonoščad (rođenu ≤ 28 tjedana gestacije) i naročito za one s anamnezom respiratorne nezrelosti.
English: It is important to follow the instructions from the doctor or nurse so that you or your child completes the course of injections.
Croatian: Važno je da slijedite upute liječnika ili medicinske sestre tako da Vi ili Vaše dijete primite sve injekcije iz ciklusa.
English: The vaccination schedules of two doses administered with an interval of one or two months showed similar immune responses in both adults and adolescents.
Croatian: Sheme cijepljenja s dvije doze koje se primjenjuju u intervalu od jednog ili dva mjeseca pokazale su slične imunološke odgovore u odraslih i adolescenata.
English: Infants and children (up to 10 years of age)
Croatian: Dojenčad i djeca (do 10 godina starosti)
English: There was no evidence of maternal or foetal toxicity, and no effects on pregnancy, maternal behaviour, female fertility, or postnatal development in a study in which female rabbits received Bexsero at approximately 10 times the human dose equivalent based on body weights.
Croatian: Nije bilo dokaza maternalne ili fetalne toksičnosti i učinaka na trudnoću, maternalno ponašanje, plodnost ženki ili postnatalni razvoj u ispitivanju u kojem su ženke kunića primale Bexsero u dozama približno 10 puta većim od ekvivalenata humanih doza prema tjelesnoj težini.
English: Immunogenicity was evaluated in infants, children, adolescents and adults.
Croatian: Imunogenost je procjenjivana u dojenčadi, djece, adolescenata i odraslih.
English: Bexsero must not be mixed with other vaccines in the same syringe.
Croatian: Bexsero se ne smije miješati s drugim cjepivima u istoj štrcaljki.
English: Although the risk for developing allergic reactions is very small, healthcare professionals should consider the benefit-risk prior to administering this vaccine to subjects with known history of hypersensitivity to latex.
Croatian: Iako je rizik od razvoja alergijskih reakcija vrlo malen, zdravstveni radnici moraju razmotriti omjer koristi/rizika prije primjene ovog cjepiva u osoba s poznatom preosjetljivošću na lateks.
English: Children and adolescents with complement deficiencies, asplenia, or splenic dysfunction
Croatian: Djeca i adolescenti s nedostacima komplementa, asplenijom ili poremećajima funkcije slezene
English: Serum bactericidal response to NHBA antigen has not been evaluated.
Croatian: Serumski baktericidni odgovor na antigen NHBA nije procijenjen.
English: However, some of the effects mentioned under section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.
Croatian: No, neke od nuspojava spomenutih u dijelu 4 „Moguće nuspojave” mogu privremeno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna doza (0,5 ml) sadrži:
English: Immunogenicity in infants and children
Croatian: Imunogenost u dojenčadi i djece
English: The safety of Bexsero was evaluated in 17 studies including 10 randomised controlled clinical trials with 10565 subjects (from 2 months of age) who received at least one dose of Bexsero.
Croatian: Sigurnost Bexsera procjenjivana je u 17 ispitivanja, uključujući 10 randomiziranih, kontroliranih kliničkih ispitivanja sa 10 565 ispitanika (od 2 mjeseca starosti) koji su primili najmanje jednu dozu
English: When Bexsero is given to you or your child, the very common side effects (may affect more than 1 in 10 people) that you or your child may get (reported in all age groups) are: - pain/tenderness at the injection site, redness of the skin at the injection site, swelling of the skin at the injection site, hardness of the skin at the injection site.
Croatian: Ako Bexsero primate Vi ili Vaše dijete, vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 osoba) koje možete dobiti Vi ili Vaše dijete (prijavljene u svim dobnim skupinama) su: - bol/osjetljivost na mjestu injiciranja, crvenilo kože na mjestu injiciranja, oticanje kože na mjestu injiciranja, otvrdnuće kože na mjestu injiciranja.
English: No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the vaccination series.
Croatian: Nije primijećeno povećanje incidencije ili težine nuspojava sa sljedećim dozama u seriji cjepiva.
English: Name and address of the manufacturers of the biological active substances (NHBA, NadA, fHbp):
Croatian: Nazivi i adrese proizvođača bioloških djelatnih tvari (NHBA, NadA, fHbp):
English: In addition to reports in clinical trials, worldwide voluntary reports of adverse reactions received for Bexsero since market introduction are included in the list.
Croatian: Dodatno na izvješća iz kliničkih ispitivanja, u popis su uključene spontane prijave nuspojava prikupljene diljem svijeta nakon stavljanja Bexera na tržište.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA
English: The clinical consequences of the reduced immunogenicity of the NHBA antigen at this schedule are not known.
Croatian: Kliničke posljedice smanjene imunogenosti antigena NHBA u toj shemi nisu poznate.
English: Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.
Croatian: No, cjepivo se ne smije uskratiti kada postoji očigledan rizik od izloženosti meningokoknoj infekciji.
English: Immune system disorders Not known: allergic reactions (including anaphylactic reactions)
Croatian: Poremećaji imunološkog sustava Nepoznato: alergijske reakcije (uključujući anafilaktičke reakcije)
English: Metabolism and nutrition disorders Very common: eating disorders
Croatian: Poremećaji metabolizma i prehrane Vrlo često: poremećaji prehrane
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency and they are consequently listed with the frequency unknown.
Croatian: Budući da te nuspojave spontano prijavljuje populacija nepoznate veličine, nije uvijek moguće pouzdano procijeniti njihovu učestalost,
English: Pharmacotherapeutic group: meningococcal vaccines, ATC code: J07AH09
Croatian: Farmakoterapijska skupina: meningokokna cjepiva, ATK oznaka: J07AH09 Mehanizam djelovanja
English: Due to an increased risk of fever, tenderness at the injection site, change in eating habits and irritability when Bexsero was co-administered with the above vaccines, separate vaccinations can be considered when possible.
Croatian: Zbog povećanog rizika od vrućice, osjetljivosti na mjestu injiciranja, promjene prehrambenih navika i iritabilnosti prilikom istodobne primjene Bexsera s gore navedenim cjepivima, odvojena cjepiva mogu se razmatrati kada je to moguće.
English: Sodium chloride, histidine, sucrose and water for injections (see section 2 for further information on sodium and latex).
Croatian: Drugi sastojci: natrijev klorid, histidin, saharoza i voda za injekcije (vidjeti dio 2 za dodatne informacije o natriju i lateksu).
English: Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see section 4.8).
Croatian: Reakcije povezane s anksioznošću, uključujući vazovagalne reakcije (sinkopa), hiperventilaciju ili reakcije povezane uz stres, mogu se javiti u vezi s cijepljenjem kao psihogeni odgovor na injekciju iglom (vidjeti dio 4.8).
English: Prophylactic administration of antipyretics at the time and closely after vaccination can reduce the incidence and intensity of post-vaccination febrile reactions.
Croatian: Profilaktička primjena antipiretika u vrijeme i neposredno nakon cijepljenja može smanjiti incidenciju i intenzitet febrilnih reakcija nakon cijepljenja.
English: ** GMT = geometric mean titer.
Croatian: ** GMT = geometrijska sredina titra.
English: No adverse reactions were seen in vaccinated maternal rabbits or in their offspring through day 29 of lactation.
Croatian: Nisu primijećene nuspojave u cijepljenih skotnih ženki kunića ili njihovoj mladunčadi tijekom 29 dana laktacije.
English: These bacteria can cause serious, and sometimes life-threatening, infections such as meningitis (inflammation of the covering of the brain and spinal cord) and sepsis (blood poisoning).
Croatian: Te bakterije mogu uzrokovati ozbiljne i katkada po život opasne infekcije, kao što je meningitis (upala moždane ovojnice i ovojnice leđne moždine) i sepsu (trovanje krvi).