natgillin/translations-raw huggingface dataset:
* rSBA testing performed at Public Health England (PHE) laboratories in UK ** hSBA tested at Neomed, Laval, Canada blood sampling performed 1 month post vaccination 
* testiranje rSBA so opravili v laboratorijih PHE (Public Health England) v Veliki Britaniji ** hSBA so testirali na inštitutu Neomed, Laval, Kanada odvzem krvi so opravili 1 mesec po cepljenju
Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap by twisting it anticlockwise. 
Primite valj brizge v eno roko (pazite, da ne boste držali bata brizge) in odvijte pokrovček brizge tako, da ga zasučete v nasprotni smeri urnega kazalca.
• received your dose more than approximately one year ago and could be at risk of infection caused by Neisseria meningitidis type A 
• prvi odmerek prejeli pred več kot približno 1 letom in pri vas ali vašem otroku obstaja posebno tveganje za okužbo z Neisserio meningitidis tipa A.
In study MenACWY-TT-039, serum bactericidal activity was also measured using hSBA as a secondary endpoint (Table 5). 
V študiji MenACWY-TT-039 so kot sekundarni opazovani dogodek merili tudi baktericidno aktivnost v serumu, in sicer s hSBA (preglednica 5).
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. 
Vendar lahko navodilo dobijo tako odrasli kot otroci in morda ga berete za svojega otroka.
Effect of Nimenrix on anti-tetanus antibody concentrations 
Vpliv cepiva Nimenrix na koncentracijo protiteles proti tetanusu
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]). 
En mesec po sočasni uporabi z adsorbiranim kombiniranim cepivom s tetanusnim toksoidom, prečiščenim davičnim toksoidom in acelularnim cepivom proti oslovskemu kašlju (Tdap) so pri preskušancih, starih od 9 do 25 let, ugotovili nižje vrednosti GMC proti vsakemu od antigenov povzročitelja oslovskega kašlja (toksoid oslovskega kašlja [PT - Pertussis Toxoid], filamentozni hemaglutinin [FHA - Filamentous Haemagglutinin] in pertaktin [PRN]).
Table 11: 1 month post-vaccination and 1 year persistence data (hSBA*) in children 6-10 years of age 
Preglednica 11: Podatki 1 mesec po cepljenju in o trajanju imunskega odziva (hSBA*) 1 leto po cepljenju pri otrocih, starih od 6 do 10 let
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. 
V študiji MenACWY-TT-084 so primerjali imunske odzive na dva odmerka cepiva Nimenrix, ki so ju dali v presledku 2 mesecev 43 preskušancem, starim od 2 do 17 let, z anatomsko ali funkcijsko asplenijo, in 43 enako starim preskušancem z normalnim delovanjem vranice.
It may be expected that in patients receiving immunosuppressive treatment, an adequate response may not be elicited. 
Pričakovati je mogoče, da cepivo ne bo izzvalo ustreznega odziva pri bolnikih, ki prejemajo imunosupresivno zdravljenje.
Booster response for subjects previously vaccinated with a conjugate meningococcal vaccine against Neisseria meningitidis 
Odziv na obnovitveni odmerek pri preskušancih, predhodno cepljenih s konjugiranim meningokoknim cepivom proti Neisseria meningitidis
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. 
Cepivo Nimenrix povzroči nastanek baktericidnih protiteles proti kapsularnim polisaharidom Neisseria meningitidis skupin A, C, W-135 in Y, merjenih s preskusi, ki uporabljajo bodisi rSBA bodisi hSBA.
Powder in a vial (type I glass) with a stopper (butyl rubber) and solvent in an ampoule (type I glass). 
Prašek v viali (steklo tipa I) z zamaškom (butilna guma) in vehikel v ampuli (steklo tipa I).
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. 
Če ima malček posebej veliko tveganje za invazivno meningokokno bolezen zaradi izpostavljenosti skupinama W-135 in Y, se lahko razmisli o drugem odmerku cepiva v razmiku 2 mesecev po prvem odmerku.
• bruising (haematoma) where the injection is given 
• podplutba (hematom) na mestu injiciranja
• rSBA titres ≥32 for initially seronegative subjects (i.e., pre-vaccination rSBA titre <8) 
• s titri rSBA  32 pri uvodoma seronegativnih preskušancih (tj. titer rSBA pred cepljenjem < 8)
Following administration of Nimenrix there is a waning of serum bactericidal antibody titres against group A when using hSBA (see section 5.1). 
Pri hSBA so po uporabi cepiva Nimenrix opazili upadanje titrov serumskih baktericidnih protiteles proti skupini A (glejte poglavje 5.1).
10 VIALS AND 10 AMPOULES 100 VIAL AND 100 AMPOULES 
PODATKI NA ZUNANJI OVOJNINI 1 VIALA IN 1 AMPULA 10 VIAL IN 10 AMPUL 100 VIAL IN 100 AMPUL
Effect of pre-vaccination antibody to tetanus toxoid The safety and immunogenicity of Nimenrix was evaluated when it was sequentially administered or co-administered with a vaccine containing, diphtheria and tetanus toxoids, acellular pertussis, inactivated polioviruses (1, 2 and 3), hepatitis B surface antigen and Haemophilus influenzae type b polyribosyl ribose phosphate conjugated to tetanus toxoid (DTaP-HBV-IPV/Hib) in the second year of life. 
Vpliv predvakcinacijskega protitelesa na tetanusni toksoid Varnost in imunogenost cepiva Nimenrix so ocenili med zaporedno ali sočasno uporabo cepiva z davičnim in tetanusnim toksoidom, acelularnim cepivom proti oslovskemu kašlju, inaktiviranimi poliovirusi (1, 2 in 3), površinskim antigenom hepatitisa B in poliribozil riboza fosfatom bakterije Haemophilus influenzae tipa b, konjugiranim na tetanusni toksoid (DTaP-HBV-IPV/Hib), v drugem letu življenja.
Thrombocytopenia and coagulation disorders 
Trombocitopenija in motnje koagulacije
Table 12: Bactericidal antibody responses (rSBA*) to Nimenrix and the ACWY-PS vaccine in adolescents aged 11-17 years and adults aged ≥ 18 years 1 month after vaccination 
Preglednica 12: Odziv baktericidnih protiteles (rSBA*) na cepivi Nimenrix in ACWY-PS pri mladostnikih (11-17 let) in odraslih (≥ 18 let) 1 mesec po cepljenju
Table 8: 5 years persistence data in toddlers aged 12-23 months at vaccination (study MenACWY-TT-032; extension of study 027) 
Preglednica 8: Podatki o 5-letnem trajanju imunskega odziva pri malčkih, ob cepljenju starih od 12 do 23 mesecev (študija MenACWY-TT-032; podaljšek študije 027)
See your doctor immediately if you notice any of these. 
Če se vam pojavi kateri od teh znakov, nemudoma pojdite k zdravniku.
Table 10: 44 months persistence data in children 2-10 years of age at vaccination (Study MenACWY-TT-088; extension of study 081) 
Preglednica 10: Podatki o 44-mesečnem trajanju imunskega odziva pri otrocih, ob cepljenju starih od 2 do 10 let (študija MenACWY-TT-088; podaljšek študije 081)
In study MenACWY-TT-104, serum bactericidal activity was also measured using hSBA as a secondary endpoint. 
V študiji Men ACWY-TT-104 so kot sekundarni opazovani dogodek merili tudi baktericidno aktivnost v serumu, in sicer s hSBA.
Trometamol Sodium chloride Water for injections 
Pomožne snovi: saharoza trometamol natrijev klorid voda za injekcije
• generally feeling unwell 
• splošno slabo počutje
The analysis of immunogenicity was conducted on ATP cohort for persistence adapted for each time-point. 
Analizo imunogenosti so opravili na kohorti ATP za trajanje, prilagojeno za vsako časovno točko.
To attach the needle to the syringe, refer to the picture. 
Za namestitev igle na brizgo glejte sliko.
In the subgroup aged >65 years the percentage of vaccines with rSBA titres ≥128 at one month post-vaccination ranged from 90% (group A) to 97% (group Y). 
V podskupini, stari > 65 let, je delež cepljenih oseb s titri rSBA ≥ 128 en mesec po cepljenju znašal od 90 % (skupina A) do 97 % (skupina Y).
• received your first dose at age 12-23 months and could be at particular risk of infection caused by Neisseria meningitidis types A, C, W-135 and Y 
• prvi odmerek prejeli pri starosti od 12 do 23 mesecev in pri vas ali vašem otroku obstaja posebno tveganje za okužbo z Neisserio meningitidis tipov A, C, W-135 in Y.
If Nimenrix is co-administered with other vaccines, different injection sites should be used. 
Če je cepivo Nimenrix uporabljeno sočasno z drugimi cepivi, ga je treba injicirati na drugo mesto.
Nimenrix must be reconstituted by adding the entire content of the ampoule of solvent to the vial containing the powder. 
Cepivo Nimenrix je treba rekonstituirati tako, da se celotno vsebino ampule z vehiklom doda v vialo s praškom.
Uncommon (these may occur with up to 1 in 100 doses of the vaccine): 
Občasni (pojavijo se lahko pri največ 1 na 100 odmerkov cepiva):
Response to Nimenrix in subjects previously vaccinated with a plain polysaccharide vaccine against Neisseria meningitidis 
Odziv na cepivo Nimenrix pri preskušancih, predhodno cepljenih z navadnim polisaharidnim cepivom proti Neisseria meningitidis
Nimenrix elicited bactericidal responses against groups W-135 and Y that were higher in terms of % with hSBA titre ≥8 when two doses were given compared with one. 
Cepivo Nimenrix je povzročilo baktericidne odzive proti skupinama W-135 in Y, ki so bili (kar zadeva odstotke s titri hSBA ≥ 8) večji pri dveh odmerkih kot pri enem samem.
Common (these may occur with up to 1 in 10 doses of the vaccine): 
Pogosti (pojavijo se lahko pri največ 1 na 10 odmerkov cepiva):
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 
Neznana: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti
Neisseria meningitidis group W-135 polysaccharide1 
Polisaharid Neisseria meningitidis skupine W-135
What you need to know before you receive Nimenrix Nimenrix should not be given if: 
Kaj morate vedeti, preden boste prejeli cepivo Nimenrix
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). 
Cepivo Nimenrix je mogoče dati kot obnovitveni odmerek pri predhodno cepljenih posameznikih, starih 12 mesecev in več, ki so prejeli osnovno cepljenje s konjugiranim ali navadnim polisaharidnim meningokoknim cepivom (glejte poglavji 4.4 in 5.1).
A different injection site will be used for each vaccine. 
Vsako cepivo je treba injicirati na drugo mesto.
Overall, at one month post-vaccination the percentage of vaccines with rSBA titres ≥ 128 ranged from 93% (group C) to 97% (group Y). 
Skupno je en mesec po cepljenju delež cepljenih oseb s titri rSBA ≥ 128 znašal od 93 % (skupina C) do 97 % (skupina Y).
• stomach and digestion problems such as diarrhoea, vomiting and nausea 
• želodčne in prebavne težave, npr. driska, bruhanje in slabost s siljenjem na bruhanje
The mixed vaccine will appear as a clear colourless solution. 
Tako zmešano cepivo je bistra, brezbarvna raztopina.
Powder in a vial (type I glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe with a stopper (butyl rubber). 
Prašek v viali (steklo tipa I) z zamaškom (butilna guma) in vehikel v napolnjeni injekcijski brizgi z zamaškom (butilna guma).
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). 
Trajanje imunskega odziva so ocenili s hSBA 1 leto po cepljenju pri otrocih, starih od 6 do 10 let, ki so prejeli začetno cepljenje v študiji MenACWY-TT-027 (preglednica 11) (glejte poglavje 4.4).
This leaflet was last revised in {MM/YYYY} Other sources of information 
Navodilo je bilo nazadnje revidirano
N VR (95% CI) 
n VR (95 % IZ)
• received your first dose at age 6-14 months and could be at particular risk of infection caused by Neisseria meningitidis types W-135 and Y 
• prvi odmerek prejeli pri starosti od 6 do 14 mesecev in pri vas ali vašem otroku obstaja posebno tveganje za okužbo z Neisserio meningitidis tipov W-135 in Y.
In the second year of life, Nimenrix can also be given concomitantly with combined diphtheriatetanus - acellular pertussis (DTaP) vaccines, including combination DTaP vaccines with hepatitis B, inactivated poliovirus or Haemophilus influenzae type b (HBV, IPV or Hib) such as DTaP-HBVIPV/Hib vaccine, and 13-valent pneumococcal conjugate vaccine. 
V drugem letu življenja se cepivo Nimenrix lahko uporabi hkrati s kombiniranimi cepivi proti davicitetanusu-oslovskemu kašlju (brezcelično) (DTaP), vključno s kombinacijo cepiv DTaP s cepivom proti hepatitisu B, otroški paralizi (inaktivirano) ali Haemophilusu influenzae tipa b (HBV, IPV ali Hib), npr. cepivom DTaP-HBV-IPV/Hib, in 13-valentnim pnevmokoknim konjugiranim cepivom.
Nimenrix will only protect against infections caused by the bacteria “Neisseria meningitidis” types A, C, W-135 and Y. 
Cepivo Nimenrix zaščiti samo pred okužbami, ki jih povzročajo bakterije “Neisseria meningitidis” tipov A, C, W-135 in Y.
Nimenrix 1 dose 
Nimenrix 1 odmerek po 1. odmerku
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. 
V dveh kliničnih študijah, eni opravljeni pri mladostnikih, starih od 11 do 17 let (študija MenACWYTT-036) in drugi pri odraslih, starih od 18 do 55 let (študija MenACWY-TT-035), so preskušanci prejeli bodisi en odmerek cepiva Nimenrix bodisi en odmerek cepiva ACWY-PS.
≥1:8 and ≥1:128 and hSBA titres ≥1:4 and ≥1:8. 
En mesec po prvem odmerku cepiva in en mesec po drugem odmerku je imel v obeh skupinah podoben odstotek preskušancev titre rSBA ≥ 1 : 8 in ≥ 1 : 128 ter titre hSBA ≥ 1 : 4 in ≥ 1 : 8.
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. 
Pri preskušancih, starejših od 12 mesecev, ki so predhodno prejeli osnovno cepljenje z monovalentnim (MenC-CRM) ali tetravalentnim konjugiranim meningokoknim cepivom (MenACWY-TT), so preučevali cepljenje z obnovitvenim odmerkom cepiva Nimenrix.
Shake well before use. 
intramuskularna uporaba Pred uporabo dobro pretresite.
Nimenrix will only confer protection against Neisseria meningitidis group A, C, W-135 and Y. The vaccine will not protect against any other Neisseria meningitidis groups. 
Cepivo Nimenrix ščiti le pred Neisseria meningitidis skupin A, C, W-135 in Y, ne pa pred drugimi skupinami Neisseria meningitidis.
Nimenrix is supplied as a white powder or cake in a single dose glass vial and a clear and colourless solvent in an ampoule. 
Cepivo Nimenrix je na voljo kot bel prašek ali pogača v stekleni viali z enkratnim odmerkom in kot bister in brezbarven vehikel v ampuli.
Powder and solvent for solution for injection in ampoule 
prašek in vehikel za raztopino za injiciranje v ampuli
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). 
Pri posameznikih, ki so bili kot malčki cepljeni in pri katerih še vedno obstaja veliko tveganje za izpostavljenost meningokokni bolezni, ki jo povzročajo skupine A, C, W-135 ali Y, se lahko razmisli o obnovitvenem odmerku (glejte poglavje 5.1).
Month 1 356 82.0% (77.6; 85.9) Year 1 350 29.1% (24.4; 34.2) Year 5 141 48.9% (40.4; 57.5) 
Nimenrix mesec 1 356 82,0 % (77,6; 85,9) leto 1 350 29,1 % (24,4; 34,2) leto 5 141 48,9 % (40,4; 57,5)
1 year persistence (study MenACWY-TT-028) 
1-letno trajanje (študija MenACWY-TT-028)
Nimenrix is supplied as a white powder or cake in a single dose glass vial and a clear and colourless solvent in a pre-filled syringe. 
Cepivo Nimenrix je na voljo kot bel prašek ali pogača v stekleni viali z enkratnim odmerkom in kot bister in brezbarven vehikel v napolnjeni injekcijski brizgi.
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). 
Trajanje imunskega odziva so ocenili z rSBA in hSBA do 5 let pri otrocih, ki so prejeli začetno cepljenje v študiji MenACWY-TT-027 (preglednica 8).
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) 
Preglednica 3: Odzivi baktericidnih protiteles (rSBA* in hSBA**) pri dojenčkih po enem odmerku pri 6 mesecih starosti in po obnovitvenem odmerku pri 15-18 mesecih starosti (študija MenACWY-TT-087)
Nimenrix is a powder and a solvent for solution for injection. 
Cepivo Nimenrix vsebuje prašek in vehikel za raztopino za injiciranje.
Table 2: Bactericidal antibody responses (rSBA* and hSBA**) in infants after two doses given 2 months apart and after a booster dose at 12 months of age (Study MenACWY-TT-083) 
Preglednica 2: Odzivi baktericidnih protiteles (rSBA* in hSBA**) pri dojenčkih po dveh odmerkih, danih v presledku 2 mesecev, in po obnovitvenem odmerku pri 12 mesecih starosti (študija MenACWY-TT-083)
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. 
Omedlevica se lahko pojavi po vsakem injiciranju z iglo ali celo pred njim.
Neisseria meningitidis group C polysaccharide1 
Polisaharid Neisseria meningitidis skupine C
(1) blood sampling performed 42 to 56 days post vaccination (2) blood sampling performed 30 to 42 days post vaccination * tested at GSK laboratories 
odvzem krvi so opravili od 42 do 56 dni po cepljenju odvzem krvi so opravili od 30 do 42 dni po cepljenju * testirano v laboratorijih družbe GSK
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. 
Od prvega leta starosti naprej se cepivo Nimenrix lahko uporabi hkrati s katerimkoli od naslednjih cepiv: cepiva proti hepatitisu A (HAV) in hepatitisu B (HBV), cepivo proti ošpicam-mumpsu-rdečkam (MMR), cepivo proti ošpicam-mumpsu-rdečkam-noricam (MMRV), 10-valentno konjugirano pnevmokokno cepivo in cepivo proti sezonski gripi brez adjuvansa.
• If you get any side effects, talk to your doctor or pharmacist. 
• Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Powder and solvent for solution for injection in a pre-filled syringe 
prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi
Meningo coccal Group 
Meningo kokna skupina
Table 9: Bactericidal antibody responses (rSBA*) to Nimenrix and the ACWY-PS vaccine in children aged 2-10 years 1 month after vaccination (study MenACWY-TT-038) 
Preglednica 9: Odziv baktericidnih protiteles (rSBA*) na cepivi Nimenrix in ACWY-PS pri otrocih, starih od 2 do 10 let, 1 mesec po cepljenju (študija MenACWY-TT-038) Meningokokna skupina
Persistence of the immune response was evaluated by hSBA up to 5 years after vaccination in adolescents and adults initially vaccinated in MenACWY-TT-052 (Table 14) (see section 4.4). 
Trajanje imunskega odziva so ocenili s hSBA do 5 let po cepljenju pri mladostnikih in odraslih, ki so prejeli začetno cepljenje v študiji MenACWY-TT-052 (preglednica 14) (glejte poglavje 4.4).
• at least a 4-fold increase in rSBA titres from pre- to post-vaccination for initially seropositive subjects (i.e., pre-vaccination rSBA titre ≥8) 
• z vsaj 4-kratnim porastom titrov rSBA od pred cepljenjem do po cepljenju pri uvodoma seropozitivnih preskušancih (tj. titer rSBA pred cepljenjem ≥ 8) * testirano v laboratorijih družbe GSK
MenCCRM vaccine 
Nimenrix cepivo MenCCRM
Month 1 334 91.0% (87.4; 93.9) Year 1 327 98.5% (96.5; 99.5) Year 5 138 87.0% (80.2; 92.1) 
Nimenrix mesec 1 334 91,0 % (87,4; 93,9) leto 1 327 98,5 % (96,5; 99,5) leto 5 138 87,0 % (80,2; 92,1)
Powder for Nimenrix MenACWY Conjugate IM 
prašek za cepivo Nimenrix Konjugat MenACWY i.m.
1conjugated to tetanus toxoid carrier protein 
5 mikrogramov konjugiran na nosilno beljakovino tetanusnega toksoida
Month 1 359 96.1% (93.5; 97.9) Year 1 336 94.9% (92.0; 97.0) Year 5 140 92.9% (87.3; 96.5) 
Nimenrix mesec 1 359 96,1 % (93,5; 97,9) leto 1 336 94,9 % (92,0; 97,0) leto 5 140 92,9 % (87,3; 96,5)
Persistence of immunogenicity was analysed using the year 5 ATP cohort. 
Za analizo trajanja imunogenosti so uporabili kohorto ATP za leto 5.
Meningococcal Group 
Meningokokna skupina
Study MenACWY-TT-104(1) 
Študija MenACWY-TT-104
10 vials: powder 10 pre-filled syringes: solvent 20 needles 
10 napolnjenih injekcijskih brizg: vehikel 20 igel
Although similar responses to groups A and C were observed with both dosing schedules, a single primary dose in infants at 6 months was associated with lower hSBA responses to groups W-135 and Y as measured by the percentage of subjects with hSBA titres ≥8 [87.2% (95% CI: 74.3, 95.2) and 92.3% (95% CI: 
Čeprav so pri obeh shemah odmerjanja ugotovili podobne odzive proti skupinama A in C, je bil enkratni osnovni odmerek pri dojenčkih, starih 6 mesecev, povezan z manjšimi odzivi hSBA proti skupinama W-135 in Y, merjeno z odstotkom preskušancev s titri hSBA ≥ 8 [87,2 % (95 % IZ: 74,3; 95,2) oz. 92,3 % (95 % IZ: 81,5; 97,9)], v primerjavi s 3 osnovnimi odmerki pri starosti 2, 4 in 6 mesecev [100 % (95 % IZ: 96,6; 100) oz. 100 % (95 % IZ: 97,1; 100)] (glejte poglavje 4.4).
Nimenrix is not likely to affect your ability to drive or use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi cepivo Nimenrix vplivalo na vašo sposobnost za upravljanje vozil ali strojev.
Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal group A, C, W-135 and Y conjugate vaccine 
Nimenrix prašek in vehikel za raztopino za injiciranje v napolnjeni injekcijski brizgi cepivo proti meningokokom skupin A, C, W-135 in Y, konjugirano
MenCTT vaccine 
em odmerku cepivo MenC-TT
Study MenACWY-TT-039(1) 
Študija MenACWY-TT-039
The clinical relevance of these observations is unknown. 
Klinični pomen teh opažanj ni znan.
Serum bactericidal activity was also measured using hSBA as a secondary endpoint. 
Kot sekundarni opazovani dogodek so merili tudi baktericidno delovanje v serumu, in sicer s hSBA.
Very common Fever Swelling at injection site Pain at injection site Redness at injection site Fatigue 
Splošne težave in spremembe na mestu aplikacije zelo pogosti zvišana telesna temperatura oteklina na mestu injiciranja bolečina na mestu injiciranja pordelost na mestu injiciranja utrujenost pogosti hematom na mestu injiciranja*
Instructions for reconstitution of the vaccine with the solvent presented in ampoules 
Navodila za rekonstitucijo cepiva z vehiklom, priloženim v ampuli
EU/1/12/767/007 - pack of 100 
EU/1/12/767/007 - pakiranje po 100
Table 13: 5 years persistence data (rSBA*) in adolescents aged 11-17 years at vaccination Menin gococc al 
Preglednica 13: Podatki o trajanju imunskega odziva (rSBA*) 5 let po cepljenju pri mladostnikih, ob cepljenju starih od 11 do 17 let
EU/1/12/767/005 - pack of 1 
EU/1/12/767/005 - pakiranje po 1
Infants from 6 weeks to less than 12 months of age: One booster dose at 12 months of age, at least 2 months after the last dose of Nimenrix. 
En obnovitveni odmerek pri starosti 12 mesecev, najmanj 2 meseca po zadnjem odmerku cepiva Nimenrix.