FrancophonIA/ELRC3.0 huggingface dataset:
English: The same study also evaluated antibody persistence data from an additional phase 3 initial study in adolescents.
Croatian: U istom ispitivanju ocjenjivali su se i podaci o postojanosti protutijela iz dodatnog inicijalnog ispitivanja faze 3 provedenog u adolescenata.
English: In case of delay, the booster should not be given later than 24 months of age.
Croatian: U slučaju odgode, docjepljivanje se smije primijeniti najkasnije do dobi od 24 mjeseca.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi tj. zanemarive količine natrija.
English: Bexsero was immunogenic in maternal animals vaccinated prior to lactation, and antibodies were detected in the offspring, but antibody levels in milk were not determined.
Croatian: Bexsero je bio imunogen u skotnih životinja cijepljenih prije laktacije i u mladunčadi su otkrivena protutijela, no razine protutijela u mlijeku nisu određene.
English: Individuals with impaired immune responsiveness, whether due to the use of immune-suppressive therapy, a genetic disorder, or other causes, may have reduced antibody response to active immunisation.
Croatian: Osobe s oštećenom sposobnošću imunološkog odgovora bilo zbog uzimanja imunosupresivne terapije, genetskog poremećaja ili drugih uzroka mogu imati smanjen odgovor protutijela na aktivnu imunizaciju.
English: Tell your doctor or nurse if you know that you or your child is allergic to latex.
Croatian: Obavijestite svojeg liječnika ili medicinsku sestru ako ste Vi ili Vaše dijete alergični na lateks.
English: The safe use of Bexsero in kanamycin-sensitive individuals has not been established.
Croatian: Sigurna primjena Bexsera u osoba osjetljivih na kanamicin nije ustanovljena.
English: *** GMT = geometric mean titer.
Croatian: *** GMT = geometrijska sredina titra.
English: Higher rates of antipyretic use were also reported for infants vaccinated with Bexsero and routine vaccines.
Croatian: Više stope primjene antipiretika također su prijavljene u dojenčadi cijepljene Bexserom i rutinskim cjepivima.
English: Do not use this vaccine after the expiry date which is stated on the carton after EXP.
Croatian: Ovo cjepivo se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „EXP”.
English: Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group B, even if they develop antibodies following vaccination with Bexsero.
Croatian: Osobe s nasljednim nedostacima komplementa (na primjer, nedostatkom C3 ili C5 komponente) i osobe koje primaju terapije koje inhibiraju aktivaciju terminalnog komplementa (na primjer, ekulizumab) imaju povećani rizik od razvoja invazivne bolesti uzrokovane bakterijom Neisseria meningitidis grupe B, čak i ako razviju protutijela nakon cijepljenja Bexserom.
English: The efficacy of Bexsero has not been evaluated through clinical trials.
Croatian: Klinička djelotvornost Djelotvornost Bexsera nije procjenjivana u kliničkim ispitivanjima.
English: In infants and children (less than 2 years of age) the most common local and systemic adverse reactions observed in clinical trials were tenderness and erythema at the injection site, fever and irritability.
Croatian: U dojenčadi i djece (mlađe od 2 godine) najčešće lokalne i sistemske nuspojave primijećene u kliničkim ispitivanjima bile su osjetljivost i eritem na mjestu injiciranja, vrućica i iritabilnost.
English: The bactericidal responses against the NHBA antigen were also high in infants vaccinated at the 2, 4, 6-month schedule, but this antigen appeared to be less immunogenic at the 2, 3, 4-month schedule.
Croatian: Baktericidni odgovori na antigen NHBA bili su također visoki u dojenčadi cijepljenje prema shemi 2, 4, 6 mjeseci, no čini se da je taj antigen manje imunogen u shemi 2, 3, 4 mjeseca.
English: The risk for developing an allergic reaction is very small, but your doctor or nurse needs to be aware of your allergy when deciding if you or your child should receive Bexsero.
Croatian: Rizik od razvoja alergijske reakcije vrlo je malen, no Vaš liječnik ili medicinska sestra moraju biti svjesni Vaše alergije kada odlučuju trebate li
English: Fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection.
Croatian: Nesvjestica, osjećaj nesvjestice ili druge reakcije povezane uz stres mogu se javiti kao odgovor na bilo koju injekciju iglom.
English: Read all of this leaflet carefully before you or your child receive this medicine because it contains important information for you or your child.
Croatian: Vi ili Vaše dijete počnete primjenjivati ovaj lijek jer sadrži Vama i Vašem djetetu važne podatke.
English: The vaccine is given by deep intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the deltoid muscle region of the upper arm in older subjects.
Croatian: Cjepivo se daje dubokom intramuskularnom injekcijom, po mogućnosti u anterolateralni dio bedra u dojenčadi ili u područje deltoidnog mišića na nadlaktici u starijih osoba.
English: Children, 2 years to 10 years
Croatian: Djeca, 2 godine do 10 godina
English: Allergic reactions that may include severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing), difficulty breathing with wheezing or coughing, rash, loss of consciousness and very low blood pressure.
Croatian: Nuspojave prijavljene nakon stavljanja lijeka na tržište uključuju: Alergijske reakcije koje mogu uključivati teško oticanje usana, usta, grla (što može uzrokovati otežano gutanje), otežano disanje sa zviždanjem pri disanju ili kašljanjem, osip, gubitak svijesti i vrlo nizak krvni tlak.
English: 2 to 5 years of age
Croatian: 2 do 5 godina
English: Collapse (sudden onset of muscle floppiness), less responsive than usual or lack of awareness, and paleness or bluish skin discoloration in young children.
Croatian: Kolaps (nagla pojava mišićne mlohavosti), slabiji odgovor nego obično ili gubitak svijesti te blijeda ili plavkasto obojena koža u male djece.
English: When given concomitantly with other vaccines Bexsero must be administered at separate injection sites (see section 4.2).
Croatian: Kada se daje istodobno s drugim cjepivima, Bexsero se mora primijeniti na zasebnom mjestu injiciranja (vidjeti dio 4.2).
English: 12 to 23 months of age Age of vaccination 6, 8 months
Croatian: 12 do 23 mjeseca Dob prilikom cijepljenja 6, 8 mjeseci
English: Three doses each of 0.5 ml
Croatian: Tri doze, svaka od 0,5 ml
English: As with any vaccine, Bexsero may not fully protect all of those who are vaccinated.
Croatian: Kao i kod drugih cjepiva, Bexsero možda neće u potpunosti zaštititi sve cijepljene osobe.
English: LIST OF EXCIPIENTS Excipients: sodium chloride, histidine, sucrose, water for injections.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: natrijev klorid, histidin, saharoza, voda za injekcije.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Bexsero in one or more subsets of the paediatric population in the prevention of meningococcal disease caused by Neisseria meningitidis group B (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Bexsero u jednoj ili više podskupina pedijatrijske populacije za sprječavanje meningokokne bolesti uzrokovane bakterijom Neisseria meningitidis grupe B (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Frequencies are defined as follows: Very common:
Croatian: Učestalosti su definirane na sljedeći način:
English: There are no data on the use of Bexsero in adults above 50 years of age.
Croatian: Ne postoje podaci o primjeni Bexsera u odraslih starijih od 50 godina.
English: Two doses each of 0.5 ml
Croatian: Dvije doze, svaka od 0,5 ml
English: The first dose should be given no earlier than 2 months of age.
Croatian: Prvu dozu treba dati najranije u dobi od 2 mjeseca.
English: White opalescent liquid suspension.
Croatian: Bijela opalescentna tekuća suspenzija.
English: Adverse reactions (following primary immunisation or booster dose) considered as being at least possibly related to vaccination have been categorised by frequency.
Croatian: Nuspojave (nakon primarne imunizacije ili booster doze) koje se smatraju barem moguće povezane s cijepljenjem kategorizirane su prema učestalosti.
English: If you have any further questions on Bexsero, ask your doctor or nurse.
Croatian: U slučaju bilo kakvih pitanja o Bexseru, obratite se liječniku ili medicinskoj sestri.
English: pre-vaccination titer <1:4
Croatian: titar prije cijepljenja <1:4
English: Prophylactic use of paracetamol reduces the incidence and severity of fever without affecting the immunogenicity of either Bexsero or routine vaccines.
Croatian: Profilaktička primjena paracetamola smanjuje incidenciju i težinu vrućice bez utjecaja na imunogenost bilo Bexsera bilo rutinskih cjepiva.
English: However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines.
Croatian: No, neke od nuspojava spomenutih u dijelu 4.8 „Nuspojave” mogu privremeno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: 13, 15 months fHbp
Croatian: 13, 15 mjeseci fHbp
English: Children 2 years to 10 years of age should receive two injections of the vaccine.
Croatian: Djeca u dobi od 2 do 10 godina trebaju primiti dvije injekcije cjepiva.
English: Vaccine efficacy has been inferred by demonstrating the induction of serum bactericidal antibody responses to each of the vaccine antigens (see section Immunogenicity).
Croatian: Djelotvornost cjepiva je dokazana postizanjem indukcije odgovora serumskih baktericidnih protutijela na svaki od antigena cjepiva (vidjeti dio Imunogenost).
English: The percentages of healthy subjects with hSBA ≥1:5 were 98% for antigen fHbp, 99% for antigen NadA, 83% for antigen PorA P1.4, and 99% for antigen NHBA.
Croatian: Postotci zdravih ispitanika s hSBA ≥1:5 bili su 98% za antigen fHbp, 99% za antigen NadA, 83% za antigen PorA P1.4, i 99% za antigen NHBA.
English: Concomitant administration of Bexsero with vaccines other than those mentioned above has not been studied.
Croatian: Istodobna primjena Bexsera s drugim cjepivima osim onih spomenutih gore nije ispitivana.
English: As these antigens are variably expressed by different strains, meningococci that express them at sufficient levels are susceptible to killing by vaccine-elicited antibodies.
Croatian: Budući da ti antigeni imaju različitu ekspresiju u različitim sojevima, meningokoki u kojima imaju dovoljnu razinu ekspresije podložni su uništenju od protutijela nastalih cijepljenjem.
English: Previously unvaccinated children also received two doses in the second year of life, with antibody persistence being measured at one year after the second dose (see Table 4).
Croatian: Prethodno necijepljena djeca također su primila dvije doze u drugoj godini života uz mjerenje postojanosti protutijela godinu dana nakon druge doze (vidjeti Tablicu 4).
English: In adolescents and adults the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.
Croatian: Najčešće prijavljene lokalne i sistemske nuspojave u adolescenata i odraslih bile su bol na mjestu injiciranja, malaksalost i glavobolja.
English: A booster dose should be considered in individuals at continued risk of exposure to meningococcal disease, based on official recommendations d
Croatian: Potrebno je razmotriti booster dozu u osoba u kojih i dalje postoji rizik od izlaganja meningokoknoj bolesti, sukladno službenim preporukama d
English: In studies with adults, data were obtained after two doses of Bexsero with a one month or two month interval between doses (see Table 9).
Croatian: U ispitivanjima u odraslih podaci su dobiveni nakon dvije doze Bexsera s intervalom od jednog ili dva mjeseca između doza (vidjeti Tablicu 9).
English: There are no data on the use of Bexsero in subjects above 50 years of age and limited data in patients with chronic medical conditions.
Croatian: Ne postoje podaci o primjeni Bexsera u osoba iznad 50 godina starosti dok su ograničeni podaci u osoba s kroničnim medicinskim stanjima.
English: An early immune response after the first dose was also evaluated.
Croatian: Ocjenjivao se i rani imunološki odgovor nakon prve doze.
English: In the initial study, whose results are summarised in Table 5, participants received two doses of Bexsero two months apart.
Croatian: U inicijalnom ispitivanju, čiji su rezultati sažeti u Tablici 5, ispitanici su primili dvije doze Bexera u razmaku od dva mjeseca.
English: Care must be taken to ensure that the vaccine is injected intramuscularly only.
Croatian: Pazite da cjepivo injicirate samo intramuskularno.
English: Talk to your doctor or nurse first.
Croatian: Najprije se obratite svom liječniku ili medicinskoj sestri.
English: There are no data in adults above 50 years of age.
Croatian: Ne postoje podaci za odrasle starije od 50 godina.
English: % 4-fold increase after 2nd dose
Croatian: % 4-strukog povećanja nakon 2. doze (95% CI)
English: Suspension for injection (0.5 ml) 1 pre-filled syringe containing 0.5 ml suspension with needles 1 pre-filled syringe containing 0.5 ml suspension without needles
Croatian: Suspenzija za injekciju (0,5 ml) 1 napunjena štrcaljka s 0,5 ml suspenzije s iglama 1 napunjena štrcaljka s 0,5 ml suspenzije bez igala
English: Common (these may affect up to 1 in 10 people) - skin rash (infants and children 2 to 10 years of age)
Croatian: Često (mogu se javiti u manje od 1 na 10 osoba) - osip na koži (dojenčad i djeca u dobi od 2 do 10 godina)
English: A decline in antibody titers to PorA P1.4 and fHbp antigens (reaching 9%-10% and 12%-20% of subjects with an hSBA ≥ 1:5, respectively) has been observed in an additional study in children 4 years of age who received a full priming and booster schedule as infants.
Croatian: Smanjenje titara protutijela na antigene PorA P1.4 i fHbp (dosežući 9%-10%, odnosno 12%-20% ispitanika s hSBA ≥ 1:5) zabilježeno je u dodatnom ispitivanju u djece u dobi od 4 godine koja su primila kompletnu primarnu imunizaciju i booster dozu kao dojenčad.
English: In clinical studies in infants vaccinated at 2, 4 and 6 months of age, fever (≥ 38°C) was reported by 69% to 79% of subjects when Bexsero was co-administered with routine vaccines (containing the following antigens: pneumococcal 7-valent conjugate, diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type b) compared with 44% to 59% of subjects receiving the routine vaccines alone.
Croatian: U kliničkim ispitivanjima u dojenčadi cijepljenih u 2., 4. i 6. mjesecu života, vrućicu (≥ 38°C) je prijavilo 69% do 79% ispitanika kada je Bexsero primjenjivan istodobno s rutinskim cjepivima (koja sadrže sljedeće antigene: pneumokokni 7-valentni konjugat, difterija, tetanus, nestanični pertusis, hepatitis B, inaktivirani virus poliomijelitisa i hemofilus tip b) u usporedbi sa 44% do 59% ispitanika koji su primali rutinska cjepiva samostalno.
English: 6 to 11 months of age
Croatian: 6 do 11 mjeseci
English: The Meningococcal Antigen Typing System (MATS) was developed to relate antigen profiles of different strains of meningococcal group B bacteria to killing of the strains in the serum bactericidal assay with human complement (hSBA).
Croatian: Meningococcal Antigen Typing System, MATS) razvijen je zbog povezivanja profila antigena različitih sojeva bakterija meningokokne grupe B s uništavanjem sojeva u testu baktericidnosti seruma s humanim komplementom (hSBA).
English: You may receive an additional injection (booster).
Croatian: Možda ćete primiti i dodatnu injekciju cjepiva (docjepljivanje).
English: Clinical studies demonstrated that the immune responses of the co-administered routine vaccines were unaffected by concomitant administration of Bexsero, based on non-inferior antibody response rates to the routine vaccines given alone.
Croatian: Klinička ispitivanja su pokazala da primjena Bexsera nije utjecala na imunološke odgovore istodobno primijenjenih rutinskih cjepiva, temeljem neinferiornih stopa odgovora protutijela u odnosu na samostalno primijenjena rutinska cjepiva.
English: Data on antibody persistence one year after the two doses at 13 and 15 months of age are also summarised in Table 4.
Croatian: Podaci o postojanosti protutijela jednu godinu nakon dvije doze u dobi od 13 i 15 mjeseci također su sažeti u Tablici 4.
English: Children, 12 months to 23 months
Croatian: Djeca, 12 mjeseci do 23 mjeseca
English: Your child may receive an additional injection (booster).
Croatian: Vaše će dijete možda primiti i dodatnu injekciju cjepiva (docjepljivanje).
English: - The interval between each injection should be at least 1 month.
Croatian: - Razmak između injekcija treba biti najmanje 1 mjesec.
English: What BEXSERO is and what it is used for
Croatian: Što je Bexsero i za što se koristi Što morate znati prije nego
English: In an extension study the persistence of the immune response was assessed one year after the booster dose (see Table 3).
Croatian: U nastavku ispitivanja postojanost imunološkog odgovora procijenjena je jednu godinu nakon booster doze (vidjeti Tablicu 3).
English: 25 micrograms produced in E. coli cells by recombinant DNA technology adsorbed on aluminium hydroxide (0.5 mg Al³+) NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein)
Croatian: 25 mikrograma proizvedeno u stanicama E. coli tehnologijom rekombinantne DNK adsorbirano na aluminijevu hidroksidu (0,5 mg Al3+) NHBA (Neisserial heparin vezujući antigen), NadA (Neisseria adhezin A), fHbp (faktor H
English: In the study in adolescents, bactericidal responses following two doses of Bexsero were stratified by baseline hSBA less than 1:4 or equal to or greater than 1:4.
Croatian: U ispitivanju u adolescenata baktericidni odgovori nakon dvije doze Bexsera su stratificirani prema početnoj vrijednosti hSBA manjoj od 1:4 ili jednakoj ili većoj od 1:4.
English: Stopping breathing or irregular breathing for a short time may be more common in the first three days following vaccination in these babies and they may need special monitoring.
Croatian: Zaustavljanje disanja ili nepravilno disanje tijekom kratkog vremena mogu biti češći u prva tri dana nakon cijepljenja kod tih beba te im može biti potreban poseban nadzor. - ako Vi ili Vaše dijete imate alergiju na antibiotik kanamicin.
English: Persistence of the immune response one year after the booster dose is also presented in Table 3.
Croatian: Postojanost imunološkog odgovora jednu godinu nakon booster doze također je prikazana u Tablici 3.
English: Sera were obtained both before vaccination, one month after the third vaccination (see Table 2) and one month after booster vaccination (see Table 3).
Croatian: Serumi su prikupljeni prije cijepljenja, jedan mjesec nakon trećeg cijepljenja (vidjeti Tablicu 2) i jedan mjesec nakon booster cijepljenja (vidjeti Tablicu 3).
English: Antibody persistence was evaluated in an extension study in children 3 to 4 years of age.
Croatian: Postojanost protutijela ocjenjivala se u nastavku ispitivanja u djece u dobi od 3 do 4 godine.
English: - A booster will be given in the second year of life after an interval of at least 2 months from the second injection.
Croatian: Docjepljivanje će se primijeniti u drugoj godini života nakon razmaka od najmanje 2 mjeseca od druge injekcije.
English: Comparable percentages of subjects were seropositive at 2 to 3 years after being previously vaccinated with either two doses followed by a booster of Bexsero (ranging from 35% to 91%) or three doses followed by a booster (ranging from 36% to 84%).
Croatian: Usporediv postotak ispitanika bio je seropozitivan 2 - 3 godine nakon prethodnog cijepljenja dvjema dozama Bexsera nakon kojih je uslijedila booster doza (raspon od 35% do 91%) ili trima dozama nakon kojih je uslijedila booster doza (raspon od 36% do 84%).
English: Bexsero (0.5 ml) will be given to you or your child by a doctor or nurse.
Croatian: Bexsero (0,5 ml) će Vama ili Vašem djetetu dati liječnik ili medicinska sestra.
English: 10 pre-filled syringes each containing 0.5 ml suspension with needles 10 pre-filled syringes each containing 0.5 ml suspension without needles
Croatian: 10 napunjenih štrcaljki, svaka s 0,5 ml suspenzije s iglama 10 napunjenih štrcaljki, svaka s 0,5 ml suspenzije bez igala
English: Antibody persistence data for the study in adolescents were obtained in an extension phase 3 study.
Croatian: Podaci o postojanosti protutijela iz ispitivanja u adolescenata dobiveni su u nastavku ispitivanja faze 3.
English: Inconsistent results were seen across studies for responses to inactivated poliovirus type 2 and pneumococcal conjugate serotype 6B and lower antibody titers to the pertussis pertactin antigen were also noted, but these data do not suggest clinically significant interference.
Croatian: Putem ispitivanja odgovora na inaktivirani poliovirus tip 2 i konjugat pneumokoka serotip 6B, utvrđeni su nesukladni rezultati i niži titri protutijela na pertaktin, antigen pertusisa, no ti podaci ne ukazuju na klinički značajan međusoban utjecaj cjepiva.
English: Very common: sleepiness, unusual crying, headache Uncommon: seizures (including febrile seizures)
Croatian: Poremećaji živčanog sustava Vrlo često: pospanost, neuobičajeno plakanje, glavobolja Manje često: napadaji (uključujući febrilne napadaje)
English: After 24-36 months, the percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) declined, ranging across strains from 21% to 74% in children 4-7 years of age and from 47% to 86% in children 8-12 years of age.
Croatian: Nakon 24 - 36 mjeseci postotak seropozitivnih ispitanika (tj. onih koji su postigli hSBA od najmanje 1:4) se smanjio pa se kod svih sojeva kretao u rasponu od 21% do 74% u djece u dobi od 4 do 7 godina, odnosno u rasponu od 47% do 86% u djece u dobi od 8 do 12 godina.
English: Similar responses were also observed for adolescents administered two doses of Bexsero with an interval of six months.
Croatian: Slični odgovori primijećeni su u adolescenata koji su primili dvije doze Bexsera u intervalu od šest mjeseci.
English: - A booster will be given after an interval of 12 to 23 months from the second injection.
Croatian: Docjepljivanje će se primijeniti nakon razmaka od najmanje 12 do 23 mjeseca od druge injekcije.
English: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Croatian: GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italija
English: These observations are consistent with adequate priming in infancy with both a two-dose and a threedose primary series followed by a booster of Bexsero.
Croatian: Ta opažanja ukazuju na adekvatnu primarnu imunizaciju u dojenačkoj dobi i uz dvije i uz tri doze primarne serije nakon kojih slijedi booster doza Bexera.
English: In the same study the response to a further dose was indicative of immunological memory as 81%-95% of subjects reached an hSBA ≥ 1:5 to PorA P1.4 and 97%-100% to fHbp antigens following further vaccination.
Croatian: U istom ispitivanju odgovor na daljnju dozu bio je indikativan za imunološko pamćenje, budući da je 81%-95% ispitanika dosegnulo hSBA ≥ 1:5 za antigen PorA P1.4 i 97%-100% za antigen fHbp nakon daljnjeg cijepljenja.
English: Three-dose primary series followed by a booster
Croatian: Primarna serija od tri doze nakon kojih slijedi booster doza
English: The immunogenicity after two doses administered two months apart in children 6 months to 23 months of age has been documented in two studies whose results are summarised in Table 4.
Croatian: Imunogenost nakon dvije doze primijenjene u razmaku od dva mjeseca u djece u dobi od 6 mjeseci do 23 mjeseca dokumentirana je u dva ispitivanja čiji su rezultati sažeti u Tablici