FrancophonIA/ELRC3.0 huggingface dataset:
English: A booster dose produced robust responses, comparable between the two dosing groups, against all four meningococcal groups.
Croatian: Docjepljivanje je proizvelo robustne odgovore protiv sve četiri grupe meningokoka koji su se mogli usporediti između dvije grupe koje su primile doze cjepiva.
English: Toddlers aged 12-14 months had similar rSBA responses to groups A, C, W-135 and Y at one month after one dose of Nimenrix or at one month after two doses of Nimenrix given two months apart.
Croatian: Kod docjepljivanja su mala djeca u dobi od 12 do 14 mjeseci imala slične rSBA odgovore na grupe A, C, W-135 i Y nakon mjesec dana od primjene jedne doze cjepiva Nimenrix ili nakon mjesec dana od primjene dvije doze cjepiva Nimenrix dane u razmaku od dva mjeseca.
English: Persistence of serum bactericidal antibody titres
Croatian: Postojanost titra serumskih baktericidnih protutijela
English: • aching muscles
Croatian: • tupi bolovi u mišićima
English: This leaflet has been written assuming the person receiving the vaccine is reading it, but it can be given to adults and children so you may be reading it for your child.
Croatian: Budući da cjepivo mogu primiti i odrasli i djeca, možda ćete čitati uputu za svoje dijete.
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0) 1 52 11 400
Croatian: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0) 1 52 11 400
English: In individuals aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus vaccine [Types 16, 18] and a combined diphtheria (reduced antigen content), tetanus and acellular pertussis vaccine.
Croatian: U osoba u dobi od 9 do 25 godina Nimenrix se može dati istodobno s cjepivom protiv humanog papilomavirusa [tipova 16, 18] i kombiniranim cjepivom protiv difterije (smanjenog sadržaja antigena), tetanusa i nestaničnog pertusisa.
English: In MenACWY-TT-038, Nimenrix was demonstrated to be non-inferior to the licensed ACWY-PS vaccine in terms of vaccine response to the four groups (A, C, W-135 and Y) (See Table 9).
Croatian: U MenACWY-TT-038 ispitivanju djelotvornost cjepiva Nimenrix bila je ista onoj odobrenog cjepiva ACWY-PS u pogledu odgovora cjepiva na četiri grupe (A, C, W-135 i Y) (vidjeti Tablicu 9).
English: 10 VIALS AND 10 AMPOULES 100 VIAL AND 100 AMPOULES
Croatian: 100 BOČICA I 100 AMPULA
English: Injection site haematoma*
Croatian: Hematom na mjestu injiciranja*
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane vrlo često
English: One month after co-administration with a 10-valent pneumococcal conjugate vaccine, lower Geometric Mean antibody Concentrations (GMCs) and opsonophagocytic assay (OPA) antibody GMTs were observed for one pneumococcal serotype (18C conjugated to tetanus toxoid carrier protein).
Croatian: Mjesec dana nakon istodobne primjene s 10-valentnim konjugiranim pneumokoknim cjepivom zamijećene su niže geometrijske srednje vrijednosti koncentracija (GMC - Geometric Mean Antibody Concentration) i niže GMT protutijela na opsonofagocitnom testu (OPA - opsonophagocytic assay) za jedan pneumokokni serotip (18C konjugiran na tetanusni toksoid proteinski nosač).
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva manje često
English: In the event of either being observed, discard the vaccine.
Croatian: U slučaju da primijetite bilo koje od navedenog, bacite cjepivo.
English: A booster dose might be considered in individuals vaccinated at toddler age remaining at high risk of exposure to meningococcal disease caused by groups A, C, W-135 or Y (see section 5.1).
Croatian: Docjepljivanje se može razmotriti u pojedinaca koji su cijepljeni kao manja djeca i u kojih još uvijek postoji visok rizik izlaganja meningokoknoj bolesti uzrokovanoj grupama A, C, W-135 ili Y (vidjeti dio 5.1).
English: The mixed vaccine will appear as a clear colourless solution.
Croatian: Pomiješano cjepivo je bistra bezbojna otopina.
English: The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration.
Croatian: Prije primjene, pripremljeno cjepivo treba vizualno pregledati na prisutnost stranih čestica i/ili promjenu izgleda.
English: If a toddler is expected to be at particular risk of invasive meningococcal disease due to exposure to groups W-135 and Y, consideration may be given to administering a second dose of Nimenrix after an interval of 2 months.
Croatian: Ako se očekuje da je malo dijete u posebnoj opasnosti od invazivne meningokokne bolesti zbog izloženosti grupama W-135 i Y, potrebno je razmotriti davanje druge doze cjepiva Nimenrix nakon intervala od 2 mjeseca.
English: The administration of Nimenrix one month after the DTaP-HBV-IPV/Hib vaccine resulted in lower rSBA GMTs against groups A, C and W-135 compared with co-administration (see section 4.5).
Croatian: Primjena cjepiva Nimenrix jedan mjesec nakon cjepiva DTaP-HBV-IPV/Hib rezultirala je nižim GMT rSBA za grupu A, C i W-135 u usporedbi s istodobnom primjenom (vidjeti dio 4.5).
English: Infants from 6 weeks to less than 6 months of age Two injections given 2 months apart at e.g. 2 and 4 months of age (the first injection may be given from the age of 6 weeks).
Croatian: Vaše dijete će primiti dvije injekcije dane u razmaku od 2 mjeseca npr. u 2. i 4. mjesecu starosti (prvu injekciju može primiti u dobi od 6 tjedana).
English: To attach the needle to the syringe, refer to the picture.
Croatian: Da biste pričvrstili iglu na štrcaljku, pogledajte sliku.
English: Study MenACWY-TT-084 compared immune responses to two doses of Nimenrix given two months apart between 43 subjects aged 2-17 years with anatomic or functional asplenia subjects and 43 age-matched subjects with normal splenic function.
Croatian: Ispitivanje MenACWY-TT-084 usporedilo je imunološke odgovore na dvije doze cjepiva Nimenrix dane u razmaku od dva mjeseca skupini od 43 ispitanika u dobi od 2 do 17 godina s anatomskom ili funkcionalnom asplenijom i skupini od 43 ispitanika iste dobi s normalnom funkcijom slezene.
English: Table 14: 1 month post-vaccination (Study MenACWY-TT-052) and 5 years (Study MenACWY-TT-059) persistence data (hSBA*) in adolescents and adults 11-25 years of age
Croatian: Tablica 14: 1 mjesec nakon cijepljenja (ispitivanje MenACWY-TT-052) i petogodišnji podaci (ispitivanje MenACWY-TT-059) o postojanosti (hSBA*) u adolescenata i odraslih u dobi od 11 do 25 godina
English: If an infant aged 6 months to less than 12 months of age is expected to be at particular risk of invasive meningococcal disease due to exposure to groups W-135 and Y, consideration may be given to administering a second primary dose of Nimenrix after an interval of 2 months.
Croatian: Ako se očekuje da je dojenče u dobi od 6 mjeseci do manje od 12 mjeseci u posebnoj opasnosti od invazivne meningokokne bolesti zbog izloženosti grupama W-135 i Y, potrebno je razmotriti davanje druge primarne doze cjepiva Nimenrix nakon intervala od 2 mjeseca.
English: In MenACWY-TT-087, infants received either a single primary dose at 6 months followed by a booster dose at 15-18 months (DTPa-IPV/Hib and 10-valent pneumococcal conjugate vaccine was co-administered at both vaccination time points) or three primary doses at 2, 4, and 6 months followed by a booster dose at 15-18 months.
Croatian: U ispitivanju MenACWY-TT-087 dojenčad je primila bilo jednokratnu primarnu dozu u dobi od 6 mjeseci, nakon koje je slijedilo docjepljivanje u dobi od 15 do 18 mjeseci (u obje vremenske točke cijepljenja bilo je istodobno primijenjeno cjepivo DTPa-IPV/Hib i 10-valentno konjugirano pneumokokno cjepivo), ili tri primarne doze u dobi od 2, 4 i 6 mjeseci, nakon kojih je slijedilo docjepljivanje u dobi od 15 do 18 mjeseci.
English: Pfizer Oy Puh/Tel: +358 (0)9 430 040
Croatian: Puh/Tel: +358 (0)9 430 040
English: (1) blood sampling performed 42 to 56 days post vaccination (2) blood sampling performed 30 to 42 days post vaccination * tested at GSK laboratories
Croatian: (1) uzimanje uzoraka krvi 42 do 56 dana nakon cijepljenja (2) Uzimanje uzoraka krvi 30 do 42 dana nakon cijepljenja * ispitano u laboratorijima tvrtke GSK
English: Nimenrix induces the production of bactericidal antibodies against capsular polysaccharides of Neisseria meningitidis group A, C, W-135 and Y when measured by assays using either rSBA or hSBA.
Croatian: Nimenrix potiče stvaranje baktericidnih protutijela protiv kapsularnih polisaharida Neisseria meningitidis grupe A, C, W-135 i Y, mjereno testom koji koristi rSBA ili hSBA.
English: A single dose was associated with lower hSBA titres to groups W-135 and Y compared with two doses given two months apart.
Croatian: Primjena jedne doze bila je povezana s nižim titrima hSBA za grupe W-135 i Y u usporedbi s primjenom dviju doza danih u razmaku od dva mjeseca.
English: Nimenrix is a powder and a solvent for solution for injection.
Croatian: Nimenrix se sastoji od praška i otapala za otopinu za injekciju.
English: Nimenrix booster vaccination in subjects previously primed with a monovalent (MenC-CRM) or a quadrivalent conjugate meningococcal vaccine (MenACWY-TT) was studied in subjects from 12 months of age onwards who received a booster vaccination.
Croatian: Docjepljivanje cjepivom Nimenrix u ispitanika koji su prethodno primili monovalentno (MenC-CRM) ili četverevalentno konjugirano meningokokno cjepivo (MenACWY-TT) ispitivano je u ispitanika starijih od 12 mjeseci koji su primili docjepljivanje.
English: In MenACWY-TT-081, Nimenrix was demonstrated to be non-inferior to another licensed MenCCRM vaccine in terms of vaccine response to group C [94.8% (95% CI: 91.4; 97.1) and 95.7% (95% CI: 89.2; 98.8) respectively], The GMT was lower for the Nimenrix group [2795 (95% CI: 2393; 3263)] versus the MenC-CRM vaccine [5292 (95% CI: 3815; 7340)].
Croatian: U ispitivanju MenACWY-TT-081, djelotvornost cjepiva Nimenrix bila je ista onoj odobrenog cjepiva MenC-CRM u smislu odgovora na cjepivo na grupu C [94,8% (95% CI: 91,4; 97,1) odnosno 95,7% (95% CI: 89,2; 98,8)] i nižeg GMT u skupini koja je primala Nimenrix [2795 (95% CI: 2393; 3263)] naspram onog u skupini koja je primala cjepivo MenC-CRM [5292 (95% CI: 3815; 7340)].
English: • Data from a study in infants aged 6 to 12 weeks at the time of the first dose (Study MenACWY-TT-083), 1,052 subjects received at least one dose of a primary series of 2 or 3 doses of Nimenrix and 1,008 received a booster dose at approximately 12 months of age.
Croatian: • Podaci dobiveni tijekom ispitivanja u dojenčadi u dobi od 6 do 12 tjedana u vrijeme prve doze (ispitivanje MenACWY-TT-083); 1052 ispitanika primilo je najmanje jednu dozu primarnih serija od 2 ili 3 doze cjepiva Nimenrix i 1008 primilo je docjepljivanje u dobi od približno 12 mjeseci.
English: In study MenACWY-TT-039, serum bactericidal activity was also measured using hSBA as a secondary endpoint (Table 5).
Croatian: U ispitivanju MenACWY-TT-039, kao sekundarna mjera ishoda također je mjerena baktericidna aktivnost u serumu primjenom hSBA (Tablica 5).
English: A different injection site will be used for each vaccine.
Croatian: Svako cjepivo treba primijeniti na drugo mjesto.
English: 1 month post-vaccination (study MenACWY-TT-027)
Croatian: 1 mjesec nakon cijepljenja (ispitivanje MenACWY-TT-027)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH MEN ACWY CONJUGATE POWDER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA SA MEN ACWY KONJUGIRANIM PRAŠKOM
English: In MenACWY-TT-083, the first dose was administered at 6 to 12 weeks of age, the second dose was given after an interval of 2 months and a third (booster) dose was given at the age of approximately 12 months.
Croatian: U ispitivanju MenACWY-TT-083 prva doza primijenjena je u dobi od 6 do 12 tjedana, druga je dana nakon intervala od 2 mjeseca i treća doza (docjepljivanje) je dana u dobi od približno 12 mjeseci.
English: In previously vaccinated individuals 12 months of age and older, Nimenrix may be given as a booster dose if they have received primary vaccination with a conjugated or plain polysaccharide meningococcal vaccine (see sections 4.4 and 5.1).
Croatian: Nimenrix se može primijeniti kao docjepljivanje u prethodno cijepljenih osoba u dobi od 12 mjeseci i starijih ako su primili primarno cijepljenje konjugiranim ili nekonjugiranim polisaharidnim meningokoknim cjepivom (vidjeti dijelove 4.4 i 5.1).
English: Nimenrix is supplied as a white powder or cake in a single dose glass vial and a clear and colourless solvent in an ampoule.
Croatian: Nimenrix je dostupan u jednoj dozi bijelog praška ili kolačića u bočici, te bistrom i bezbojnom otapalu u napunjenoj štrcaljki.
English: (≥1/100 to <1/10)
Croatian: (≥ 1/100 i < 1/10)
English: How Nimenrix works
Croatian: Kako Nimenrix djeluje
English: Effect of prior vaccination with plain polysaccharide meningococcal vaccine Subjects previously vaccinated with a plain polysaccharide meningococcal vaccine and vaccinated with Nimenrix 30 to 42 months later had lower Geometric Mean Titres (GMTs) measured with a serum bactericidal assay using rabbit complement (rSBA) than subjects who had not been vaccinated with any meningococcal vaccine in the preceding 10 years (see section 5.1).
Croatian: Učinak prethodnog cijepljenja nekonjugiranim polisaharidnim meningokoknim cjepivom Osobe koje su prethodno cijepljene nekonjugiranim polisaharidnim meningokoknim cjepivom i 30 do 42 mjeseca kasnije cjepivom Nimenrix, imale su nižu geometrijsku srednju vrijednost titra (GMTGeometric Mean Titre) mjerenu u ispitivanju baktericidnosti seruma korištenjem komplementa kunića (rSBA - rabbit complement serum bactericidal assay) od osoba koje uopće nisu bile cijepljene meningokoknim cjepivom u prethodnih 10 godina (vidjeti dio 5.1).
English: Very common Drowsiness Headache
Croatian: Omamljenost Glavobolja manje često
English: Extensive limb swelling at the injection site, frequently associated with erythema, sometimes involving the adjacent joint or swelling of the entire injected limb *Nausea and Injection site haematoma occurred at a frequency of Uncommon in infants **Rash occurred at a frequency of Common in infants ***ADR identified post-marketing
Croatian: Opsežno oticanje ekstremiteta na mjestu injiciranja, koje se često povezuje s eritemom, a ponekad zahvaća i susjedni zglob, ili oticanje cijelog ekstremiteta u koji je cjepivo injicirano *Mučnina i hematom na mjestu primjene javili su se pri učestalosti Manje često u dojenčadi ** Osip se pojavio pri učestalosti Često u dojenčadi ***ADR identificiran nakon stavljanja lijeka u promet
English: Immunogenicity in toddlers aged 12-23 months
Croatian: Imunogenost u male djece u dobi od 12 do 23 mjeseca
English: If you are not sure, talk to your doctor or nurse before you receive Nimenrix.
Croatian: Ako niste sigurni, prije dobivanja cjepiva Nimenrix razgovarajte s liječnikom ili medicinskom sestrom.
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
Croatian: Manje česte (mogu se javiti u do 1 na 100 doza cjepiva):
English: Trometamol Solvent:
Croatian: saharoza trometamol
English: Time point (year)
Croatian: Vrem. točka (godine)
English: In a separate study (MenACWY-TT-085) a single dose of Nimenrix was administered to 194 Lebanese adults 56 years of age and older (including 133 aged 56-65 years and 61 aged >65 years).
Croatian: U zasebnom je ispitivanju (MenACWY-TT-085) jedna doza cjepiva Nimenrix primijenjena u 194 odrasla Libanonca u dobi od 56 ili više godina (uključujući 133 ispitanika u dobi od 56 do 66 godina i 61 ispitanika starijeg od 65 godina).
English: From age 1 year and above, Nimenrix can be given concomitantly with any of the following vaccines: hepatitis A (HAV) and hepatitis B (HBV) vaccines, measles - mumps - rubella (MMR) vaccine, measles - mumps - rubella - varicella (MMRV) vaccine, 10-valent pneumococcal conjugate vaccine or unadjuvanted seasonal influenza vaccine.
Croatian: U dobi od 1 godine i više, Nimenrix se može dati istodobno s bilo kojim od sljedećih cjepiva: cjepivo protiv hepatitisa A (HAV) i hepatitisa B (HBV), cjepivo protiv morbila, parotitisa i rubele (MPR), cjepivo protiv morbila, parotitisa, rubele i varičela (MPRV), 10-valentno konjugirano pneumokokno cjepivo ili cjepivo protiv sezonske gripe bez adjuvansa.
English: Robust anamnestic responses to the antigen(s) in the priming vaccine were observed.
Croatian: Zabilježeni su robustni anamnestički podaci odgovora na protutijela kod primarnog cijepljenja.
English: In study MenACWY-TT-021 conducted in subjects aged 4.5-34 years, the immunogenicity of Nimenrix administered between 30 and 42 months after vaccination with a ACWY-PS vaccine was compared to the immunogenicity of Nimenrix administered to age-matched subjects who had not been vaccinated with any meningococcal vaccine in the preceding 10 years.
Croatian: U ispitivanju MenACWY-TT-021 provedenom na ispitanicima u dobi od 4,5 do 34 godine, imunogenost cjepiva Nimenrix danog između 30 i 42 mjeseca nakon cijepljenja cjepivom ACWY-PS je uspoređivana s imunogenosti cjepiva Nimenrix danog ispitanicima iste dobi koji tijekom prethodnih deset godina nisu bili cijepljeni bilo kojim meningokoknim cjepivom.
English: In a separate study (MenACWY-TT-085) a single dose of Nimenrix was administered to 194 Lebanese adults 56 years of age and older (including 133 aged 56-65 years and 61 aged > 65 years).
Croatian: U zasebnom je ispitivanju (MenACWY-TT-085) jedna doza cjepiva Nimenrix primijenjena u 194 odrasla Libanonca u dobi od 56 ili više godina (uključujući 133 ispitanika u dobi od 56 do 66 godina i u 61 ispitanika starijeg od 65 godina).
English: These must be mixed together before use.
Croatian: Prašak i otapalo treba pomiješati prije primjene.
English: * rSBA testing performed at Public Health England (PHE) laboratories in UK ** hSBA tested at Neomed, Laval, Canada blood sampling performed 1 month post vaccination
Croatian: *rSBA testiranje provedeno je u laboratorijima Zavoda za javno zdravstvo Engleske (PHE) u Ujedinjenom Kraljevstvu **hSBA testiran u Neomedu, Laval, Kanada uzorkovanje krvi provedeno je 1 mjesec nakon cijepljenja
English: One month after co-administration with a combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Tdap) in subjects aged 9 to 25 years, lower GMCs were observed to each pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]).
Croatian: U ispitanika u dobi od 9 do 25 godina, mjesec dana nakon istodobne primjene s kombiniranim cjepivom protiv tetanusa (toksoidom), difterije (smanjenog sadržaja toksoida) i pertusisa (nestaničnim), adsorbiranim (engl. tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine; Tdap), zamijećene su niže vrijednosti GMC-a kao odgovor na svaki pojedini antigen pertusisa (toksoid pertusisa [engl. pertussis toxoid, PT], filamentozni hemaglutinin [FHA] i pertaktin [PRN]).
English: Powder in a vial (type I glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe with a stopper (butyl rubber).
Croatian: Prašak u bočici (staklo tip I) s čepom (butil) i otapalo u napunjenoj štrcaljki s čepom klipa (butil guma).
English: 1 year persistence (study MenACWY-TT-028)
Croatian: Postojanost nakon 1 godine (ispitivanje MenACWY-TT-028)
English: titre ≥8) was observed against all groups (A, C, W-135, Y) in all subjects regardless of the meningococcal vaccine history.
Croatian: Imunološki odgovor (rSBA titar ≥8) je zapažen u svim grupama (A, C, W-135, Y) u svih ispitanika bez obzira na prethodno cijepljenje meningokoknim cjepivom (vidjeti dio 4.4).
English: Common (these may occur with up to 1 in 10 doses of the vaccine):
Croatian: Česte (mogu se javiti u do 1 na 10 doza cjepiva):
English: Nimenrix must be reconstituted by adding the entire content of the ampoule of solvent to the vial containing the powder.
Croatian: Nimenrix se mora rekonstituirati dodavanjem cijelog sadržaja ampule s otapalom u bočicu koja sadrži prašak.
English: Very common Irritability Uncommon
Croatian: Razdražljivost manje često
English: Persistence of the immune response was evaluated by hSBA 1 year after vaccination in children 6-10 years of age who were initially vaccinated in study MenACWY-TT-027 (Table 11) (see section 4.4).
Croatian: Postojanost imunološkog odgovora je procijenjena pomoću hSBA jednu godinu nakon cijepljenja u djece u dobi od 6 do 10 godina koja su primarno cijepljena u ispitivanju MenACWY-TT-027 (Tablica 11) (vidjeti dio 4.4).
English: Study (Age range)
Croatian: Ispitivanje (Dobni raspon)
English: Previously vaccinated individuals 12 months of age and older: Please tell your doctor if you have received a previous injection with another meningococcal vaccine than Nimenrix.
Croatian: Molimo obavijestite svog liječnika ako ste prethodno primili injekciju nekog drugog meningokoknog cjepiva koje nije Nimenrix.
English: • rSBA titres ≥32 for initially seronegative subjects (i.e., pre-vaccination rSBA titre <8)
Croatian: • titrima rSBA 32 u inicijalno seronegativnih ispitanika (tj. titar pred cijepljenje <8)
English: Not known: frequency cannot be estimated from the available data • injection site swelling and redness; this may affect a large area of the vaccinated limb
Croatian: Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka
English: (≥1/1,000 to <1/100)
Croatian: (≥ 1/1000 i < 1/100)
English: Immunogenicity in adolescents aged 11-17 years and adults aged ≥ 18 years In two clinical studies, conducted in adolescents 11-17 years of age (study MenACWY-TT-036) and in adults 18-55 years of age (study MenACWY-TT-035), either one dose of Nimenrix or one dose of the ACWY-PS vaccine were administered.
Croatian: U dva klinička ispitivanja provedena u adolescenata u dobi od 11 do 17 godina (ispitivanje MenACWY-TT-036) i u odraslih u dobi od 18 do 55 godina (ispitivanje MenACWY-TT-035), primijenjene su jedna doza cjepiva Nimenrix, ili jedna doza cjepiva ACWY-PS.
English: Persistence of the immune response was evaluated by rSBA and hSBA up to 5 years in children initially vaccinated in study MenACWY-TT-027 (Table 8).
Croatian: Postojanost imunološkog odgovora procjenjivana je pomoću rSBA i hSBA do 5 godina u djece primarno cijepljene u ispitivanju MenACWY-TT-027 (Tablica 8).
English: Regarding waning of antibody against group A or group C after a first dose of Nimenrix in children aged 12-23 months, see under Persistence of serum bactericidal antibody titres.
Croatian: A ili C nakon prve doze cjepiva Nimenrix u djece u dobi od 12 do 23 mjeseca, vidjeti dio „Postojanost titra serumskih baktericidnih protutijela“.
English: Nimenrix 2 doses
Croatian: Nimenrix 2 doze
English: Response to Nimenrix in subjects previously vaccinated with a plain polysaccharide vaccine against Neisseria meningitidis
Croatian: Odgovor na Nimenrix u ispitanika koji su prethodno cijepljeni nekonjugiranim polisahardnim cjepivom protiv bakterije Neisseria meningitidis
English: Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection.
Croatian: Kao psihogeni odgovor na ubod injekcijom, osobito u adolescenata, nakon ili čak i prije samog cijepljenja može doći do sinkope (gubitka svijesti).
English: Month 1 364 95.1% (92.3; 97.0) Year 1 356 97.8% (95.6; 99.0) Year 5 142 94.4% (89.2; 97.5) The analysis of immunogenicity was conducted on ATP cohort for persistence adapted for each timepoint.
Croatian: 1.mjesec 364 95,1% (92,3; 97,0) 1. godina 356 97,8% (95,6; 99,0) 5. godina 142 94,4% (89,2; 97,5) Analiza imunogenosti je provedena na ATP-kohorti za postojanost, prilagođeno za svaku vremensku točku.
English: Table 3: Bactericidal antibody responses (rSBA* and hSBA**) in infants after one dose at 6 months of age and after a booster dose at 15-18 months of age (Study MenACWY-TT-087)
Croatian: Tablica 3: Odgovori baktericidnih protutijela (rSBA* i hSBA**) u dojenčadi nakon primjene jedne doze u dobi od 6 mjeseci i nakon docjepljivanja u dobi od 15 do 18 mjeseci (ispitivanje MenACWY-TT-087)