FrancophonIA/ELRC3.0 huggingface dataset:
English: After the booster dose the GMCs elicited by Synflorix were lower for most serotypes in common with 7-valent Prevenar.
Croatian: Nakon doze docjepljivanja GMC-i postignuti uz Synflorix bili su niži za većinu serotipova zajedničkih sa 7
English: Instructions for administration of the vaccine 1.
Croatian: Upute za primjenu cjepiva
English: Table 8: Percentage of 3-dose primed subjects with antibody concentrations ≥ 0.20 µg/ml one month post-primary and one month post-booster Antibody
Croatian: Tablica 8: Postotak ispitanika primarno cijepljenih s 3 doze, s koncentracijom protutijela ≥ 0,20 µg/ml jedan mjesec nakon primarnog cijepljenja i jedan mjesec nakon doze docjepljivanja protutijelo
English: In COMPAS, serotypes 5 (2 cases), 18C (4 cases) and 23F (1 case) were detected in control group in addition to serotypes 6B and 14.
Croatian: U ispitivanju COMPAS su uz serotipove 6B i 14 u kontrolnoj skupini pronađeni i serotipovi 5 (2 slučaja), 18C (4 slučaja) i 23F (1 slučaj).
English: 4-dose vial
Croatian: 4-dozna bočica
English: 1 adsorbed on aluminium phosphate
Croatian: 1 adsorbirani na aluminijev fosfat ukupno 0,5 miligrama
English: For the cross-reactive serotype 19A, the results did not suggest any differences in ELISA antibody GMCs and OPA GMTs between groups.
Croatian: Za ukriženo reaktivni serotip 19A, rezultati nisu ukazali na razlike između skupina s obzirom na ELISA
English: Kawasaki disease
Croatian: Krvožilni poremećaji vrlo rijetko Kawasakijeva bolest
English: 92.7% of subjects achieved ELISA antibody concentrations ≥ 0.20 µg/ml and at least 81.7% achieved OPA titres ≥ 8 except serotype 1 (at least 58.8% with OPA titres ≥ 8).
Croatian: Jedan mjesec nakon primarnog cijepljenja (tj. nakon treće doze), za svaki serotip sadržan u cjepivu najmanje 92,7% djece je postiglo ELISA koncentraciju protutijela ≥ 0,20 µg/ml, a najmanje 81,7% je postiglo OPA titre ≥ 8, osim za serotip 1 (najmanje 58,8% s OPA titrom ≥ 8).
English: 2-dose vial
Croatian: 2-dozna bočica
English: The first dose may be given as early as 6 weeks of age with a second dose administered 2 months later.
Croatian: Prva doza može se primijeniti već u dobi od navršenih 6 tjedana, a druga doza 2 mjeseca nakon prve doze.
English: 0.5 milligram Al3+ in total 2 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
Croatian: 1 adsorbirani na aluminijev fosfat ukupno 0,5 miligrama Al3+ 2 konjugirani na protein D, proteinski nosač (dobiven iz netipiziranog Haemophilus influenzae)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Synflorix injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Synflorix injekcija i.m.
English: • Synflorix is available in pre-filled syringes for 1 dose with or without needles in packs of 1, 10 or 50.
Croatian: • Synflorix za 1 dozu je dostupan u pakiranju od 1, 10 ili 50 napunjenih štrcaljki sa ili bez igala.
English: If your child gets any side effects, talk to your doctor or pharmacist.
Croatian: Ako Vaše dijete dobije bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: In a large-scale phase III/IV, double-blind, cluster-randomized, controlled, clinical trial in Finland (FinIP), children were randomised into 4 groups according to the two infant vaccination schedules [2-dose (3, 5 months of age) or 3-dose (3, 4, 5 months of age) primary schedule followed by a booster dose as of 11 months of age] to receive either Synflorix (2/3rd of clusters) or hepatitis vaccines as control (1/3rd of clusters).
Croatian: U velikom dvostruko slijepom, klaster-randomiziranom, kontroliranom kliničkom ispitivanju faze III/IV provedenom u Finskoj (FinIP), djeca su bila randomizirana u 4 skupine prema dva rasporeda cijepljenja za dojenčad [primarna imunizacija s 2 doze (u 3. i 5. mjesecu života) ili 3 doze (u 3., 4. i 5. mjesecu života) te zatim doza docjepljivanja u dobi od 11 mjeseci ili više].
English: For most vaccine serotypes and serotype 19A, group comparisons did not suggest any differences post-booster dose in ELISA antibody GMCs and OPA GMTs between the HIV+/+ and HIV-/- groups, or the HIV+/- and HIV-/- groups.
Croatian: Za većinu serotipova sadržanih u cjepivu, usporedbe nisu ukazale na razlike u imunološkom odgovoru nakon primarnog cijepljenja između skupina HIV+/+ i HIV-/- kao ni između skupina HIV+/- i HIV-/-,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Synflorix suspension for injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Synflorix suspenzija za injekciju i.m.
English: A booster (fourth) dose is recommended at least 6 months after the last primary dose and may be given from the age of 9 months onwards (preferably between 12 and 15 months of age) (see sections 4.4 and 5.1).
Croatian: Primjena doze docjepljivanja (četvrte doze) (docjepljivanje) preporučuje se najmanje 6 mjeseci nakon posljednje doze primarne imunizacije i može se primijeniti od navršenih 9 mjeseci nadalje (po mogućnosti u dobi između 12 i 15 mjeseci) (vidjeti dijelove 4.4 i 5.1).
English: Table 7: Percentage of 2-dose primed subjects with antibody concentrations ≥ 0.20 µg/ml one month post-primary and one month post-booster Antibody
Croatian: Tablica 7: Postotak ispitanika primarno cijepljenih s 2 doze, s koncentracijom protutijela ≥ 0,20 µg/ml jedan mjesec nakon primarnog cijepljenja i jedan mjesec nakon doze docjepljivanja protutijelo
English: How to store Synflorix
Croatian: Kako čuvati Synflorix
English: In children as of 2 years of age, fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if your child fainted with a previous injection.
Croatian: Kod djece od 2 godine može se dogoditi nesvjestica nakon, ili čak i prije bilo kojeg uboda s iglom.
English: Efficacy against any NTHi AOM episode was 35.3% (95% CI: 1.8; 57.4).
Croatian: Djelotvornost protiv bilo koje epizode AOM-a uzrokovanog netipiziranim H. influenzae iznosila je 35,3% (95% CI: 1,8; 57,4).
English: Very common Fever ≥ 38 °C rectally (age < 2 years), pain, redness, swelling at the injection site.
Croatian: Opći poremećaji i reakcije na mjestu primjene vrlo često vrućica ≥ 38°C rektalno (dob < 2 godine), bol, crvenilo, oticanje na mjestu injekcije često vrućica > 39°C rektalno (dob < 2 godine),
English: Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Synflorix should receive 23-valent pneumococcal polysaccharide vaccine.
Croatian: Kad god se to preporučuje, rizična djeca u dobi od ≥ 24 mjeseca koja su već primila primarni ciklus cjepiva
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČ
English: Control(2)
Croatian: Prilagođena učinkovitost(2)
English: Children with sickle cell disease
Croatian: Djeca s anemijom srpastih stanica
English: Synflorix suspension for injection in pre-filled syringe Synflorix suspension for injection Synflorix suspension for injection in multidose container (2 doses) Synflorix suspension for injection in multidose container (4 doses)
Croatian: Synflorix suspenzija za injekciju u višedoznom spremniku (2 doze) Synflorix suspenzija za injekciju u višedoznom spremniku (4 doze)
English: For each of the seven serotypes in common, 87.7% to 100% of Synflorix vaccinees and 92.1% to 100% of 7-valent Prevenar vaccinees reached an OPA titre ≥ 8 one month after the third dose.
Croatian: 100% cijepljenih cjepivom Synflorix i 92,1% do 100% cijepljenih 7-valentnim cjepivom Prevenar postigli su OPA titar ≥8 jedan mjesec nakon treće doze.
English: Non-typeable Haemophilus influenzae (NTHi)
Croatian: Netipizirani Haemophilus influenzae (NTHi) CI interval pouzdanosti (1) prva epizoda
English: Pneumococcal polysaccharide serotype 6B1,2
Croatian: Pneumokokni polisaharid serotipa 6B1,2
English: Immunologic non-inferiority to 7-valent Prevenar
Croatian: 7-valentni Prevenar
English: Read the package leaflet before use Intramuscular use
Croatian: Prije uporabe pročitajte uputu o lijeku.
English: • Synflorix is available in vials for 4 doses in packs of 10 or 100.
Croatian: • Synflorix je dostupan u bočicama za 4 doze u pakiranju od 10 ili 100.
English: Very rare ( these may occur with up to 1 in 10,000 doses of the vaccine)
Croatian: Vrlo rijetko (mogu se pojaviti u do 1 na 10 000 doza cjepiva)
English: EU/1/09/508/013 - pack of 100
Croatian: EU/1/09/508/013 - pakiranje od 100
English: Immunogenicity following a fourth dose (booster dose) at 15 to 18 months of age was evaluated in 44 very preterm, 69 preterm and 127 full term infants.
Croatian: 15 do 18 mjeseci je procjenjivana u 44 znatno prijevremeno rođene dojenčadi, 69 dojenčadi rođene prije termina i 127 u terminu rođene dojenčadi.
English: 10 pneumococcal vaccine serotypes
Croatian: Bilo koji pneumokokni serotip 10 pneumokoknih serotipova zastupljenih u cjepivu
English: Pneumococcal polysaccharide serotype 19F1,4
Croatian: Pneumokokni polisaharid serotipa 19F1,4
English: 4-dose container Sodium chloride 2-phenoxyethanol Water for injections
Croatian: 4-dozni spremnik natrijev klorid 2-fenoksietanol voda za injekcije
English: Pneumococcal polysaccharide serotype 9V1,2
Croatian: Pneumokokni polisaharid serotipa 9V1,2
English: A clinical study conducted in Burkina Faso assessed the immunogenicity of Synflorix administered to 146 children with SCD (haemoglobin SS disease, haemoglobin SC disease or with β-thalassemia) compared to 143 age-matched children without SCD.
Croatian: Faso ocjenjivala se imunogenost cjepiva Synflorix primijenjenog u 146 djece s anemijom srpastih stanica (bolest hemoglobina SS, bolest hemoglobina
English: Very common (these may occur with more than 1 in 10 doses of the vaccine)
Croatian: Vrlo često (mogu se pojaviti u više od 1 na 10 doza cjepiva)
English: In Finland, Synflorix was introduced into NIP with a 2+1 schedule in infants (3, 5 months of age and a booster dose at 12 months) without catch-up campaign.
Croatian: Finskoj je Synflorix uveden u NPI s rasporedom cijepljenja 2+1 u dojenčadi (u dobi od 3, 5 mjeseci i doza docjepljivanja u 12 mjesecu) bez naknadne provedbe nakon propuštene ili odgođene imunizacije.
English: Post-marketing experience Immune system disorders
Croatian: Iskustva nakon stavljanja u promet Poremećaji imunološkog sustava vrlo rijetko anafilaksija
English: Higher OPA GMTs in the group boosted at 15-18 months of age were observed for most of the vaccine serotypes and serotype 19A.
Croatian: Opaženi su viši OPA GMT-i za većinu serotipova sadržanih u cjepivu kao i za serotip 19A
English: • Synflorix is available in vials for 1 dose in packs of 1, 10 or 100
Croatian: • Synflorix za 1 dozu je dostupan u pakiranju od 1, 10 ili 100 bočica
English: After first opening of the 4-dose vial, the vaccine may be stored for a maximum of 28 days in a refrigerator (2°C - 8°C).
Croatian: Nakon prvog otvaranja 4-dozne bočice, cjepivo treba čuvati u hladnjaku (2°C - 8°C), najduže 28 dana.
English: Non-inferiority was demonstrated as the upper limit of the 2-sided 95% CI of the antibody GMC ratios was below 2 for each of the 10 vaccine serotypes and for serotype 19A.
Croatian: Ne-inferiornost pokazana kao gornja granica 2-stranog 95% CI omjera GMC protutijela bila je ispod 2
English: Pack size of 1, 10 or 100.
Croatian: Veličina pakiranja: 10 ili 100.
English: Among the 15,447 children in the catch-up vaccinated cohorts, there were no culture-confirmed IPD cases in the Synflorix groups while 5 vaccine serotype IPD cases were observed in the control groups (serotypes 4, 6B, 7F, 14 and 19F).
Croatian: U 15 447 djece u cijepljenim kohortama nakon naknadne provedbe cijepljenja nakon propuštene ili odgođene imunizacije, nije bilo kulturom potvrđenih slučajeva IPB-a u Synflorix grupi dok je u kontrolnim grupama zabilježeno 5 IPB slučajeva izazvanih serotipovima zastupljenim u cjepivu
English: Pack size of 10 or
Croatian: Veličina pakiranja: 1,10 ili
English: A fine white deposit with a clear colourless supernatant may be observed upon storage of the pre-filled syringe.
Croatian: Tijekom čuvanja napunjene štrcaljke može se uočiti fini bijeli talog s bistrim bezbojnim supernatantom.
English: Pneumococcal polysaccharide serotype 23F1,2
Croatian: Pneumokokni polisaharid serotipa 23F1,2
English: MARKETING AUTHORISATION NUMBER(S) EU//1/09/508/009
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU//1/09/508/009
English: (5) in the ATP cohort VE was 100% (95% CI: 74.3; 100; 0 versus 16 cases)
Croatian: (95% CI: 74,3; 100; 0 naspram 16 slučajeva)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MULTIDOSE (4 DOSES)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA VIŠEDOZNOJ BOČICI (4 DOZE)
English: IPD(1)
Croatian: Tipovi IPB-a(1)
English: The mean duration follow-up from 2 weeks post-dose 3 in the ATP cohort was 23 months (range from 0 to 34 months) for the interim analysis (IA) and 30 months (range from 0 to 44 months) for the end-of-study analysis.
Croatian: (raspon: 0 - 34 mjeseca) za međuanalizu te 30 mjeseci (raspon: 0 - 44 mjeseca) za analizu na kraju ispitivanja.
English: The clinical relevance of these differences is unclear, as Synflorix was observed to be effective against IPD caused by serotype 6B in a doubleblind, cluster-randomized clinical study (see Table 1).
Croatian: Synflorix učinkovit protiv IPB-a uzrokovanog serotipom 6B (vidjeti Tablicu 1).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA NAPUNJENOJ ŠTRCALJKI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/508/012 - pack of 10
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/508/012 - pakiranje od 10
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4 doses (0.5 ml/dose)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 4 doze (0,5 ml/dozi)
English: • If your child gets any side effects, talk to your doctor or pharmacist.
Croatian: • Ako Vaše dijete razvije bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MULTIDOSE (2 DOSES)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA VIŠEDOZNOJ BOČICI (2 DOZE)
English: LIST OF EXCIPIENTS Sodium chloride 2-phenoxyethanol Water for injections
Croatian: natrijev klorid 2-fenoksietanol voda za injekcije
English: Instructions for administration of the vaccine presented in pre-filled syringe 1.
Croatian: Upute za primjenu cjepiva u napunjenoj štrcaljki
English: What Synflorix is and what it is used for What you need to know before your child receives Synflorix How Synflorix is given
Croatian: Što je Synflorix i za što se koristi Što morate znati prije nego
English: Pneumococcal polysaccharide serotype 7F1,2
Croatian: Pneumokokni polisaharid serotipa 7F1,2
English: EU/1/09/508/008 - pack of 100
Croatian: EU/1/09/508/008 - pakiranje od 100
English: asplenia, HIV infection, chronic illness, or those who have other immunocompromising conditions) placing them at higher risk for invasive disease due to Streptococcus pneumoniae.
Croatian: asplenije, HIV infekcije, kronične bolesti ili drugih imunokompromitirajućih stanja).
English: Use with prophylactic administration of antipyretics
Croatian: Primjena s antipireticima u profilaktičkoj primjeni
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses (0.5 ml/dose)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2 doze (0,5 ml/dozi)
English: At the end-of-study analysis (ATP cohort), the vaccine efficacy (first episodes) against B-CAP was 18.2% (95% CI: 4.1; 30.3), against C-CAP 22.4% (95% CI: 5.7; 36.1) and against clinically suspected CAP referred for X-ray 7.3% (95% CI: 1.6; 12.6).
Croatian: iznosila je 18,2% (95% CI: 4,1; 30,3), protiv C-CAP 22,4% (95% CI: 5,7; 36,1), a protiv klinički suspektnog CAP-a upućenog na rendgensko snimanje 7,3% (95% CI: 1,6; 12,6).
English: Anti-1 98.7 Anti-4 99.3 Anti-5 100
Croatian: Anti-9V 99,3 Anti-14
English: 0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (butyl rubber).
Croatian: 0,5 ml suspenzije u bočici (staklo tip I) za 1 dozu s čepom (butil guma).
English: 2 ml of suspension in a vial (type I glass) for 4 doses with a stopper (butyl rubber).
Croatian: 2 ml suspenzije u bočici (staklo tip I) za 4 doze s čepom (butil guma).
English: Impact on nasopharyngeal carriage (NPC)
Croatian: Utjecaj na nazofaringealno kliconoštvo
English: Two-dose primary series
Croatian: Primarna imunizacija s dvije doze
English: In comparative clinical studies, the incidence of local and general adverse events reported within 4 days after each vaccination dose was within the same range as after vaccination with 7-valent Prevenar.
Croatian: 4 dana nakon svake doze cijepljenja bila je u jednakom rasponu kao nakon cijepljenja 7-valentnim cjepivom Prevenar.
English: EU/1/09/508/007 - pack of 10
Croatian: EU/1/09/508/007 - pakiranje od 10
English: The immune response to Synflorix for each of the vaccine serotypes and serotype 19A, as well as for protein D, did not appear to be influenced by SCD.
Croatian: Čini se da anemija srpastih stanica nije utjecala na imunološki odgovor na Synflorix, tj. niti na jedan od serotipova sadržanih u cjepivu, serotip 19A kao ni na protein D.
English: Frequencies are reported as: Very common: (≥1/10) Common:
Croatian: Učestalost nuspojava definirana je na sljedeći način: Vrlo često:
English: B-1330 Rixensart Belgium
Croatian: BE-1330 Rixensart
English: • feeling sleepy
Croatian: • osjećaj pospanosti
English: Pneumococcal polysaccharide serotype 11,2
Croatian: Pneumokokni polisaharid serotipa 11,2
English: 1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (butyl rubber).
Croatian: 1 ml suspenzije u bočici (staklo tip I) za 2 doze s čepom (butil guma).
English: The reduction in B-CAP and C-CAP was greatest in children < 36 months of age (vaccine efficacy of 20.6% (95% CI: 6.5; 32.6) and 24.2% (95% CI: 7.4; 38.0) respectively).
Croatian: < 36 mjeseci (djelotvornost cjepiva iznosila je 20,6% (95% CI: 6,5; 32,6) odnosno 24,2% (95% CI: 7,4; 38,0)).
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in multidose container (4 doses) 10 MULTIDOSE vials (4 doses per vial - 0.5 ml per dose) 100 MULTIDOSE vials (4 doses per vial - 0.5 ml per dose)
Croatian: 10 VIŠEDOZNIH bočica (4 doze po bočici - 0,5 ml po dozi) 100 VIŠEDOZNIH bočica (4 doze po bočici - 0,5 ml po dozi)
English: A clinical study conducted in South Africa assessed the immunogenicity of Synflorix after 3-dose (610-14 weeks of age) or 2-dose (6-14 weeks of age) priming followed by a booster dose at 9-10 months of age.
Croatian: Synflorix nakon primarne imunizacije s 3 doze (u dobi od 6 - 10 - 14 tjedana) ili s 2 doze (u dobi od 6 - 14 tjedana) te doze docjepljivanja u dobi od 9 - 10 mjeseci.
English: Pneumococcal polysaccharide serotype 141,2
Croatian: Pneumokokni polisaharid serotipa 141,2
English: In the study conducted in South Africa, the booster dose given at 9-10 months of age induced marked increases in antibody GMCs and OPA GMTs for each vaccine serotype and serotype 19A in both 2dose and 3-dose priming groups indicative of immunological priming.
Croatian: 9 - 10 mjeseci potaknula je značajno povećanje GMC-a protutijela i OPA GMT-a za svaki serotip sadržan u cjepivu kao i za serotip 19A i u skupini koja je primarno cijepljenja s 2 doze i u onoj cijepljenoj s 3 doze, što ukazuje na primarni imunološki odgovor.
English: Three-dose primary series
Croatian: Primarna imunizacija s 3 doze
English: Pneumococcal polysaccharide serotype 51,2
Croatian: Pneumokokni polisaharid serotipa 51,2
English: In clinical studies the immunogenicity of Synflorix was evaluated after a 2-dose primary vaccination series (470 subjects) according to different schedules (including 6-14 weeks, 2-4 or 3-5 months of age) and after a third (booster) dose (470 subjects) given at least 6 months after the last primary dose and from the age of 9 months onwards.
Croatian: 2 doze (u 470 ispitanika) prema različitim rasporedima (uključujući primjenu u dobi od 6 - 14 tjedana, 2 - 4 mjeseca ili 3 - 5 mjeseci) kao i nakon treće doze (docjepljivanja) (u 470 ispitanika) koja se davala najmanje 6 mjeseci nakon posljednje doze primarne imunizacije i od navršenih 9 mjeseci života nadalje.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/508/006 - pack of 1
Croatian: 12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/508/006 - pakiranje od 1
English: 3-dose primary schedule
Croatian: neovisno o primarnom rasporedu cijepljenja.
English: OPA titre ≥ 8 for each vaccine serotype was comparable or higher in the catch-up group than in the 3dose primed infants.
Croatian: Udio ispitanika s ELISA mjerenom koncentracijom protutijela ≥ 0,20 µg/ml ili OPA titrom ≥ 8 za svaki serotip iz cjepiva bio je usporediv ili viši u skupini koja se cijepila nakon naknadne provedbe nakon propuštene ili odgođene imunizacije nego u dojenčadi primarno cijepljenih s tri doze.
English: Serotype 6B IPD 0
Croatian: IPB uzrokovan serotipom 6B IPB uzrokovan serotipom
English: The antibody GMCs and OPA GMTs were lower after 2-dose for most vaccine serotypes.
Croatian: Za većinu serotipova sadržanih u cjepivu, GMC-i protutijela i OPA GMT-i bili su niži nakon rasporeda s 2 doze.
English: Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Croatian: Cjepivo protiv pneumokoka, polisaharidno, konjugirano, adsorbirano
English: Pneumococcal polysaccharide serotype 41,2
Croatian: Pneumokokni polisaharid serotipa 41,2
English: In the nested Finnish study, a significant reduction was also observed for individual serotypes 14, 23F and, in the 3 dose primary schedule, for the cross-reactive serotype 19A.
Croatian: U ugniježđenom finskom ispitivanju primijećeno je i značajno smanjenje pojedinačnih serotipova 14 i
English: Syringe cap
Croatian: Klip štrcaljke
English: Preterm infants (born after 27 weeks and less than 37 weeks of pregnancy): Your child (from 2 months to 6 months of age) will receive 3 injections with an interval of at least one month between each dose.
Croatian: Vaše dijete (u dobi od 2 mjeseca do 6 mjeseci) će primiti 3 injekcije u razmaku od najmanje jednog mjeseca između svake doze.
English: 2100 Gödöllö
Croatian: Homoki Nagy István utca 1. 2100 Gödöllö
English: In a clinical study NPC was assessed in HIV positive infants (N = 83) and HIV negative infants born from HIV positive mothers (N = 101) and compared to HIV negative infants born from HIV negative mothers (N = 100).
Croatian: (N = 83) i HIV-negativne dojenčadi koju su rodile HIV-pozitivne majke (N = 101) u usporedbi s
English: In a large-scale phase III, randomized, double-blind clinical trial (Clinical Otitis Media and Pneumonia Study - COMPAS) conducted in Argentina, Panama and Colombia, healthy infants aged 6 to 16 weeks received either Synflorix or hepatitis B control vaccine at 2, 4 and 6 months of age followed respectively by either Synflorix or hepatitis A control vaccine at 15 to 18 months of age.
Croatian: Synflorix ili cjepivo protiv hepatitisa B kao kontrolu u 2., 4. i 6. mjesecu života, nakon čega im je u dobi od 15 do 18 mjeseci primijenjen ili Synflorix ili cjepivo protiv hepatitisa A kao kontrola.
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Croatian: Rijetko (mogu se pojaviti u manje od 1 na 1000 doza cjepiva)
English: Check with your doctor or pharmacist before this vaccine is given if: • your child has a bleeding problem or bruises easily.
Croatian: Provjerite s liječnikom ili ljekarnikom prije primjene ovog cjepiva:
English: The vaccine is for intramuscular use only.
Croatian: Cjepivo je namijenjeno isključivo primjeni u mišić.
English: 50 doses (0.5 ml)
Croatian: 50 napunjenih štrcaljki 50 doza (0,5 ml)
English: Store in the original package in order to protect from light Should be used within 6 hours after first broaching of the vial
Croatian: Mora se upotrijebiti unutar 6 sati od prvog otvaranja bočice.