FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common Irritability Uncommon Crying abnormal
Croatian: Psihijatrijski poremećaji vrlo često razdražljivost manje često abnormalan plač
English: Synflorix was shown to be immunogenic and no new safety concerns were observed in this study.
Croatian: Synflorix je pokazao imunogenost i nisu primjećeni novi utjecaji na sigurnost u ovom ispitivanju.
English: There was no impact of co-administration on the other nine pneumococcal serotypes.
Croatian: Istodobna primjena nije utjecala na preostalih devet pneumokoknih serotipova.
English: The interval between the pneumococcal conjugate vaccine (Synflorix) and the 23-valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
Croatian: Razmak između pneumokoknog konjugiranog cjepiva (Synflorix) i 23-valentnog pneumokoknog polisaharidnog cjepiva ne smije biti manji od 8 tjedana.
English: Signs of an allergic reaction may include itchy skin rash, being short of breath and swelling of the face or tongue.
Croatian: Znakovi alergijske reakcije mogu uključivati osip na koži popraćen osjećajem svrbeži, nedostatak daha, otečenost lica ili jezika.
English: • high temperature of 38° C or higher (fever)
Croatian: • visoka temperatura od 38°C ili viša (vrućica)
English: The safety and efficacy of Synflorix in children over 5 years of age have not been established.
Croatian: Nije utvrđena djelotvornost i sigurnost primjene cjepiva Synflorix u djece starije od 5 godina.
English: 1 microgram
Croatian: 1 mikrogram
English: • Do not use this medicine after the expiry date which is stated on the carton.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake EXP.
English: Pneumonia of different aetiologies is a leading cause of childhood morbidity and mortality globally.
Croatian: Upala pluća različitih etiologija vodeći je uzrok pobola i smrtnosti u dječjoj dobi diljem svijeta.
English: Synflorix is not intended for use in adults.
Croatian: Synflorix nije namijenjen primjeni u odraslih.
English: Studies with an 11-valent vaccine formulation representative for Synflorix revealed no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity.
Croatian: Ispitivanja s 11-valentnom formulacijom cjepiva za Synflorix nisu otkrila poseban rizik za ljude na osnovi konvencionalnih ispitivanja farmakologije sigurnosti primjene, toksičnosti pojedinačne doze i ponovljenih doza.
English: Other medicines and Synflorix
Croatian: Drugi lijekovi i Synflorix
English: After first opening of the 2-dose vial, immediate use is recommended.
Croatian: Nakon prvog otvaranja 2-dozne bočice, preporučuje se neposredna primjena.
English: As with other vaccines, it may be expected that in patients receiving immunosuppressive treatment an adequate response may not be elicited.
Croatian: Poput ostalih cjepiva, može se očekivati da u bolesnika koji primaju imunosupresivnu terapiju izostane primjereni imunološki odgovor.
English: In both studies there were significant decrease of individual serotypes 6B and 19F.
Croatian: U oba je ispitivanja primijećeno značajno smanjenje pojedinačnih serotipova 6B i 19F.
English: However, children who received 7-valent Prevenar for the primary series would not be primed against the additional serotypes contained in Synflorix (1, 5, 7F).
Croatian: Međutim, djeca koja su primila 7-valentni Prevenar u primarnom cijepljenju neće biti primovakcinirana za dodatne serotipove sadržane u cjepivu Synflorix (1, 5, 7F).
English: • Kawasaki disease (major signs of the illness are for instance: fever, skin rash, swollen lymph glands, inflammation and rash of the mucous membranes of the mouth and throat)
Croatian: • Kawasakijeva bolest (glavni znakovi bolesti su na primjer: vrućica, kožni osip, otečene limfne žlijezde, upala i osip sluznica usta i grla)
English: Alternatively, when Synflorix is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5 ml may be given.
Croatian: Alternativno, kada se Synflorix primjenjuje kao dio rutinskog nacionalnog programa imunizacije dojenčadi, može se cijepiti slijedom od ukupno tri doze, svaka od 0,5 ml.
English: If not used within 6 hours it should be discarded.
Croatian: Ako se ne primijeni u roku od 6 sati treba ga ukloniti.
English: For children above 5 years old safety and efficacy of the vaccine have not been established, therefore vaccination of these children is not recommended.
Croatian: Sigurnost i djelotvornost cjepiva u djece starije od 5 godina nisu ustanovljene, pa se ne preporučuje cijepljenje te djece.
English: Epidemiological data
Croatian: Epidemiološki podaci
English: Before NIP
Croatian: Prije NPI-a
English: Of these, 76, 96 and 49 infants, respectively, received a booster dose.
Croatian: Među njima je 76, 96, odnosno 49 dojenčadi primilo i dozu docjepljivanja.
English: Synflorix is always injected into a muscle.
Croatian: Synflorix se uvijek primjenjuje injekcijom u mišić.
English: Immune memory
Croatian: Imunološka memorija
English: The response to serotype 7F was in the same range as for the seven serotypes in common between the two vaccines.
Croatian: Odgovor na serotip 7F bio je u istom rasponu kao i za sedam zajedničkih serotipova u oba cjepiva.
English: 1-dose and 2-dose containers 4 years
Croatian: 1-dozni i 2-dozni spremnici 4 godine
English: Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age.
Croatian: Aktivna imunizacija protiv invazivne bolesti, upale pluća i akutne upale srednjeg uha izazvanih bakterijom Streptococcus pneumoniae u dojenčadi i djece u dobi od 6 tjedana do 5 godina.
English: Synflorix helps your body to make its own antibodies.
Croatian: Synflorix pomaže tijelu Vašeg djeteta u stvaranju vlastitih protutijela.
English: The vaccine efficacy against B-CAP observed at the interim analysis is presented below (table 2).
Croatian: Djelotvornost cjepiva protiv B-CAP opažena u međuanalizi prikazana je u sljedećoj tablici (tablica 2).
English: The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact on pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographical areas.
Croatian: Primjena cjepiva Synflorix mora biti temeljena na osnovi službenih preporuka koje uzimaju u obzir utjecaj pneumokoknih bolesti u različitim dobnim skupinama kao i varijabilnost epidemiologije u različitim zemljopisnim područjima.
English: Reactogenicity was higher in children receiving whole cell pertussis vaccines concomitantly.
Croatian: Reaktogenost je bila veća u djece koja su istovremeno primala cjelostanično cjepivo protiv pertusisa.
English: The HIV exposure or infection did not appear to alter the effect of Synflorix on pneumococcal carriage up to 24-27 months of age, i.e. up to 15 months following booster vaccination.
Croatian: Čini se da izloženost HIV-u ili HIV infekcija nisu promijenili učinak cjepiva Synflorix na kliconoštvo pneumokoka do dobi od 24 - 27 mjeseci, tj. do 15 mjeseci nakon docjepljivanja.
English: Children aged 12 months to 5 years will receive 2 injections.
Croatian: Djeca u dobi od 12 mjeseci do 5 godina primit će 2 injekcije.
English: If you are not sure, talk to your doctor or pharmacist before having Synflorix.
Croatian: Ako niste sigurni, posavjetujte se s liječnikom ili ljekarnikom prije primjene cjepiva Synflorix.
English: • Children aged 7-11 months received 2 primary doses followed by a booster dose in the second year of life.
Croatian: • Djeca u dobi od 7 do 11 mjeseci primila su 2 doze primarne imunizacije nakon čega je slijedila doza docjepljivanja u drugoj godini života.
English: It is not known whether this lower functional immune response against serotypes 1 and 5 will result in lower protective efficacy against invasive disease, pneumonia or otitis media caused by these serotypes (see section 5.1).
Croatian: Nije poznato hoće li ovakva slabija funkcionalna reakcija protiv serotipova 1 i 5 rezultirati slabijom zaštitnom djelotvornošću protiv invazivne bolesti, upale pluća ili upale srednjeg uha izazvanih ovim serotipovima (vidjeti dio 5.1).
English: If your child misses an injection, it is important that you make another appointment.
Croatian: Ako Vaše dijete propusti injekciju, važno je dogovoriti sljedeći posjet liječniku.
English: The first clinical study evaluated the immune responses for vaccine serotypes and the cross-reactive serotype 19A in children aged 7-11 months, 12-23 months and 2 to 5 years:
Croatian: U prvom kliničkom ispitivanju procjenjivali su se imunološki odgovori na serotipove sadržane u cjepivu i ukriženo reaktivni serotip 19A u djece u dobi od 7 do 11 mjeseci, 12 do 23 mjeseca i 2 do 5 godina:
English: There is insufficient evidence that Synflorix provides protection against pneumococcal serotypes not contained in the vaccine except the cross-reactive serotype 19A (see section 5.1) or against nontypeable Haemophilus influenzae.
Croatian: Nema dovoljno dokaza da Synflorix pruža zaštitu od pneumokoknih serotipova koji nisu sadržani u cjepivu osim ukriženo reaktivnog serotipa 19A (vidjeti dio 5.1.) ili od netipiziranog Haemophilus influenzae.
English: Therefore the degree and duration of protection against invasive pneumococcal disease and otitis media due to these three serotypes in children of this age group following a single dose of Synflorix cannot be predicted.
Croatian: Stoga se stupanj i trajanje zaštite protiv invazivne pneumokokne bolesti i upale srednjeg uha izazvane s ova tri serotipa, u djece ove dobne skupine nakon jednokratne doze cjepiva Synflorix, ne mogu predvidjeti.
English: Pre-booster GMCs (8 to 12 months after the last primary dose) were generally similar for the two vaccines.
Croatian: GMC-i prije doze docjepljivanja (8 do 12 mjeseci nakon posljednje doze primarne imunizacije) općenito su bili slični za oba cjepiva.
English: What Synflorix is and what it is used for
Croatian: Što je Synflorix i za što se koristi
English: Prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions.
Croatian: Profilaktička primjena antipiretika prije ili odmah nakon primjene cjepiva može smanjiti incidenciju i intenzitet febrilnih reakcija nakon cijepljenja.
English: The immune responses elicited by Synflorix in previously unvaccinated older children were evaluated in three clinical studies.
Croatian: Imunološki odgovor izazvan cjepivom Synflorix u prethodno necijepljene djece procjenjivan je u trima kliničkim ispitivanjima.
English: • The first injection may be given from the age of 6 weeks onwards.
Croatian: • Prva injekcija se može dati u dobi od 6 tjedana nadalje.
English: Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, prenatal exposure to anti-retroviral therapy and/or to HIV, or other causes, may have reduced antibody response to vaccination.
Croatian: Djeca s oslabljenim imunološkim odgovorom, bilo zbog primjene imunosupresivne terapije, genetskog nedostatka, HIV-infekcije, prenatalne izloženosti antiretrovirusnoj terapiji i/ili HIV-u ili drugih uzroka, mogu imati slabiji odgovor stvaranjem protutijela na cijepljenje.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Croatian: Kao kod ostalih injicirajućih cjepiva, mora se osigurati dostupnost odgovarajuće medicinske skrbi i nadzora u slučaju rijetke anafilaktičke reakcije nakon primjene cjepiva.
English: Infants aged 7 to 11 months will receive 2 injections.
Croatian: Dojenčad u dobi od 7 do 11 mjeseci primit će 2 injekcije.
English: In each group, persistence of the immune responses was observed at 24-27 months of age, i.e. up to 15 months following booster vaccination.
Croatian: U svakoj je skupini perzistencija imunološkog odgovora opažena u dobi od 24 - 27 mjeseci, tj. do 15 mjeseci nakon docjepljivanja.
English: In both schedules, a booster response indicative of immunological priming was observed.
Croatian: U oba rasporeda primijećen je odgovor na docjepljivanje indikativan za primarni imunološki odgovor.
English: Likely bacterial CAP (B-CAP) is defined as radiologically confirmed CAP cases with either alveolar consolidation/pleural effusion on the chest X-ray, or with non-alveolar infiltrates but with C reactive protein (CRP) ≥ 40 mg/l.
Croatian: Izgledan bakterijski CAP (B-CAP) definira se kao radiološki potvrđeni slučajevi CAP-a kod kojih je utvrđena ili alveolarna konsolidacija/pleuralna efuzija na rendgenskoj snimci prsišta ili nealveolarni infiltrati uz vrijednosti C-reaktivnog proteina (CRP) ≥ 40 mg/l.
English: Pack size of 1, 10 or 50.
Croatian: Veličina pakiranja: 1, 10 ili 50.
English: Clinical data generated with paracetamol and ibuprofen suggest that the prophylactic use of paracetamol might reduce the fever rate, while prophylactic use of ibuprofen showed a limited effect in reducing fever rate.
Croatian: Klinički podaci dobiveni primjenom paracetamola i ibuprofena ukazuju da profilaktička primjena paracetamola može smanjiti stopu vrućice, dok profilaktička primjena ibuprofena pokazuje ograničeni učinak u smanjenju stope vrućice.
English: As with other vaccines, the administration of Synflorix should be postponed in subjects suffering from acute severe febrile illness.
Croatian: Poput ostalih cjepiva, primjenu cjepiva Synflorix treba odgoditi u djece koja pate od teške akutne febrilne bolesti.
English: Infants from 6 weeks to 6 months of age:
Croatian: Dojenčad u dobi od 6 tjedana do 6 mjeseci:
English: What Synflorix looks like and contents of the pack
Croatian: Kako Synflorix izgleda i sadržaj pakiranja
English: The clinical data suggest that paracetamol might reduce the immune response to Synflorix.
Croatian: Klinički podaci ukazuju da paracetamol može smanjiti imunološki odgovor na Synflorix.
English: PHARMACEUTICAL FORM Suspension for injection (injection).
Croatian: OBLIK Suspenzija za injekciju (injekcija).
English: For children > 12 months of age, the risk of pain at the injection site may increase with increasing age.
Croatian: U djece starije od 12 mjeseci, s povećanjem dobi se može povećati rizik od bolnosti na mjestu primjene cjepiva.
English: The following side effects may happen with this medicine:
Croatian: Uz ovo cjepivo moguće su sljedeće nuspojave:
English: The vaccine should be given by intramuscular injection.
Croatian: Cjepivo se daje intramuskularnom injekcijom.
English: Severe allergic reactions may very rarely occur (with up to 1 in 10,000 doses of the vaccine).
Croatian: Teške alergijske reakcije mogu se javiti vrlo rijetko (u do 1 na 10 000 doza cjepiva).
English: In preterm infants born after at least 27 weeks of gestational age, the recommended immunisation series consists of four doses, each of 0.5 ml.
Croatian: U prijevremeno rođene dojenčadi, nakon barem 27 tjedana gestacije, preporučeni raspored imunizacije sastoji se od ukupno četiri doze, svaka od 0,5 ml.
English: Efficacy was 100% (95% CI: 41.9; 100) against bacteraemic pneumococcal pneumonia or empyema due to vaccine serotypes.
Croatian: Djelotvornost cjepiva iznosila je 100% (95% CI: 41,9; 100) protiv bakterijemijske pneumokokne upale pluća ili empijema uzrokovanog serotipovima u sastavu cjepiva.
English: Invasive pneumococcal disease (which includes sepsis, meningitis, bacteraemic pneumonia and bacteraemia)
Croatian: Invazivna pneumokokna bolest (koja uključuje sepsu, meningitis, bakterijemijsku upalu pluća i bakterijemiju)
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: In prospective studies, Streptococcus pneumoniae was estimated to be responsible for 30-50% of pneumonia cases.
Croatian: prospektivnim ispitivanjima procijenjeno je da 30 - 50% slučajeva upale pluća uzrokuje Streptococcus pneumoniae.
English: Enhancement of antibody response to Hib-TT conjugate, diphtheria and tetanus antigens was observed.
Croatian: Primijećen je pojačan odgovor protutijelima na Hib-TT konjugat, antigene difterije i tetanusa.
English: Clinical studies demonstrated that the immune responses and the safety profiles of the co-administered vaccines were unaffected, with the exception of the inactivated poliovirus type 2 response, for which inconsistent results were observed across studies (seroprotection ranging from 78% to 100%).
Croatian: Klinička ispitivanja su pokazala da imunološki odgovori i sigurnosni profili istodobno primjenjivanih cjepiva nisu promijenjeni, s iznimkom imunološkog odgovora na inaktivirani poliovirus tipa 2, za koji su primijećeni nekonzistentni rezultati tijekom ispitivanja (seroprotekcija koja varira od 78% do
English: If Synflorix is co-administered with other vaccines, different injection sites should be used.
Croatian: Ako se Synflorix primjenjuje istovremeno s drugim cjepivima, trebaju se primijeniti na različitim mjestima injiciranja.
English: Safety assessment of Synflorix was based on clinical trials involving the administration of 63,905 doses of Synflorix to 22,429 healthy children and 137 preterm infants as primary vaccination.
Croatian: Sigurnost primjene cjepiva Synflorix ocijenjena je na temelju kliničkih ispitivanja koja su obuhvatila primjenu 63 905 doza cjepiva Synflorix u 22 429 zdrave djece i 137 prijevremeno rođene dojenčadi kao primarno cijepljenje.
English: In addition, as otitis media and pneumonia are caused by many microorganisms other than the Streptococcus pneumoniae serotypes represented by the vaccine, the overall protection against these diseases is expected to be limited and substantially lower than protection against invasive disease caused by the serotypes in the vaccine and serotype 19A (see section 5.1).
Croatian: Osim toga, s obzirom da upalu srednjeg uha i upalu pluća mogu izazvati mnogi drugi mikroorganizmi osim serotipova Streptococcus pneumoniae sadržanih u cjepivu, očekuje se da će ukupna zaštita od tih bolesti biti ograničena i znatno niža od zaštite protiv invazivne bolesti koju uzrokuju serotipovi sadržani u cjepivu i serotip 19A (vidjeti dio 5.1).
English: Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Your doctor may ask you to give your child a medicine that lowers fever (such as paracetamol) before or immediately after Synflorix is given, especially in children being vaccinated with Synflorix and vaccines containing whole cell pertussis at the same time.
Croatian: Liječnik će možda zatražiti da djetetu date lijek za snižavanje vrućice (kao što je paracetamol) prije ili neposredno nakon primjene cjepiva Synflorix, a osobito ako dijete istodobno prima Synflorix i cjepiva koja sadrže cjelostaničnu komponentu protiv hripavca.
English: To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock.
Croatian: Da biste pričvrstili iglu na štrcaljku, okrećite iglu u smjeru kazaljke na satu dok ne osjetite da je čvrsto sjela na svoje mjesto.
English: No increase in the incidence of AOM due to other bacterial pathogens or non-vaccine/non-vaccine related serotypes was observed in either COMPAS (based on the few cases reported) or POET trial.
Croatian: Nije primijećen porast incidencije AOM-a uzrokovanog drugim bakterijskim patogenima ili serotipovima koji nisu sadržani u cjepivu/koji nisu povezani sa serotipovima zastupljenim u cjepivu ni u ispitivanju COMPAS (na temelju malobrojnih prijavljenih slučajeva) ni u ispitivanju POET.
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine) • itching, blood clot, bleeding or a small lump where the injection is given
Croatian: Manje često (mogu se pojaviti u manje od 1 na 100 doza cjepiva) • svrbež, krvni ugrušak, krvarenje ili mala kvržica na mjestu davanja injekcije
English: In infants, the most common adverse reactions observed after primary vaccination were redness at the injection site and irritability which occurred after approximately 41% and 55% of all doses respectively.
Croatian: U dojenčadi, najčešće nuspojave primijećene nakon primarnog cijepljenja bile su crvenilo na mjestu injekcije i razdražljivost, koji su se pojavili nakon približno 41% odnosno 55% svih doza.
English: However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Croatian: Međutim lakša infekcija, kao što je prehlada, ne treba biti razlogom odgađanja cijepljenja.
English: Safety and immunogenicity data for Synflorix are not available for individuals in other specific immunocompromised groups and vaccination should be considered on an individual basis (see section
Croatian: Nisu dostupni podaci o sigurnosti primjene i imunogenosti cjepiva Synflorix kod pripadnika drugih specifičnih imunokompromitiranih skupina, pa odluku o cijepljenju treba donijeti na individualnoj osnovi (vidjeti dio 4.2).
English: Table 1: Number of vaccine serotype IPD cases and vaccine effectiveness (FinIP) or efficacy (COMPAS) in infants below 7 months of age at enrolment receiving at least one vaccine dose (Infant total vaccinated cohort)
Croatian: Tablica 1: Broj slučajeva IPB-a uzrokovanog serotipovima zastupljenima u cjepivu i učinkovitost (FinIP) ili djelotvornost (COMPAS) cjepiva u dojenčadi mlađe od 7 mjeseci u trenutku uključivanja u ispitivanje koja su primila najmanje jednu dozu cjepiva (cjelokupna kohorta cijepljene dojenčadi)
English: If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog cjepiva, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Children should receive the dose regimen of Synflorix that is appropriate to their age at the time of commencing the vaccination series (see section 4.2).
Croatian: Djecu se mora cijepiti cjepivom Synflorix dozom koja odgovara njihovoj dobi u trenutku početka ciklusa cijepljenja (vidjeti dio 4.2).
English: However if your child has received paracetamol before or immediately after Synflorix is given, the obtained levels of antibodies may be slightly reduced.
Croatian: Međutim, ako Vaše dijete primi paracetamol prije ili neposredno nakon primjene cjepiva Synflorix, postignute razine protutijela mogu biti blago snižene.
English: In both schedules, a booster response indicative of immunological priming was observed for each vaccine serotype (Table 7 and Table 8).
Croatian: U oba rasporeda cijepljenja primijećen je odgovor na docjepljivanje indikativan za primarni imunološki odgovor za svaki serotip sadržan u cjepivu (Tablica 7 i Tablica 8).
English: Based on immunological bridging of the functional vaccine response (OPA) of Synflorix with the 11-valent formulation used within POET, it is expected that Synflorix provides similar protective efficacy against pneumococcal AOM.
Croatian: Na temelju imunološkog prenošenja funkcionalnog odgovora na cjepivo (OPA) cjepiva Synflorix i 11-valentne formulacije, koja je primijenjena u okviru ispitivanja POET, očekuje se slična zaštitna djelotvornost cjepiva Synflorix protiv pneumokoknog AOM-a.
English: In a nested study, infants were followed up till approximately 21 months of age to assess impact on nasopharyngeal carriage and physician-diagnosed AOM reported by parents.
Croatian: U ugniježđenom ispitivanju dojenčad je praćena do približno 21 mjeseca života s ciljem ocjenjivanja utjecaja na nazofaringealno kliconoštvo te AOM koji su prijavili roditelji, a dijagnosticirao liječnik.