FrancophonIA/ELRC3.0 huggingface dataset:
English: 81.5, 97.9), respectively] compared with three primary doses at 2, 4, and 6 months of age [100% (95% CI: 96.6, 100) and 100% (95% CI: 97.1, 100), respectively] (see section 4.4).
Maltese: W-135 u Y kif imkejla mill-perċentwal ta' individwi b'titri hSBA ≥8 [87.2% (95% CI: 74.3, 95.2) u 92.3% (95% CI: 81.5, 97.9), rispettivament] meta mqabbel ma' tliet dożi primarji f'età ta' xahrejn, 4 u 6 xhur [100% [95% CI: 96.6, 100) u 100% (95% CI: 97.1, 100), rispettivament] (ara sezzjoni 4.4).
English: The local and general adverse reaction profile of a booster dose of Nimenrix given to subjects from 12 months through 30 years of age after primary vaccination with Nimenrix or other conjugated or plain polysaccharide meningococcal vaccines, was similar to the local and general adverse reaction profile observed after primary vaccination with Nimenrix, except for gastrointestinal symptoms (including diarrhoea, vomiting, and nausea), which were very common among subjects 6 years of age and older.
Maltese: Il-profil tar-reazzjonijiet avversi lokali u ġenerali tat-tilqima ta' rinforz ta' Nimenrix mogħtija lil individwi minn 12-il xahar sa 30 sena wara tilqima primarja b'Nimenrix jew vaċċini talpolysaccharide konjugati jew sempliċi tal-meningokokkus, kien simili għall-profil tar-reazzjonijiet avversi lokali u ġenerali osservat wara t-tilqima primarja b'Nimenrix, ħlief għas-sintomi gastrointestinali (inkluż dijarea, rimettar, u dardir) li kienu komuni ħafna fost individwi li kellhom minn 6 snin 'il fuq.
English: Nimenrix powder and solvent for solution for injection in ampoule Meningococcal group A, C, W-135 and Y conjugate vaccine
Maltese: Nimenrix trab u solvent għal soluzzjoni għall-injezzjoni f'ampulla Vaċċin konjugat tal-gruppi A, C, W-135 u Y tal-meningokokkus
English: 10 vials: powder 10 ampoules: solvent 10 x 1 dose (0.5 ml)
Maltese: 10 kunjetti : trab 10 ampulli: solvent 10 x doża 1 (0.5 ml)
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.
Maltese: • Dejta minn studju fuq trabi li kellhom minn 6 sa 12-il ġimgħa meta ngħataw l-ewwel doża (Studju MenACWY-TT-083), fejn 1,052 individwu rċevew mill-anqas doża waħda minn serje primarja ta' 2 jew 3 dożi ta' Nimenrix u 1,008 irċevew doża booster meta kellhom madwar 12il xahar.
English: Infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be administered.
Maltese: Trabi minn età ta' 6 xhur, tfal, adolexxenti u adulti: għandha tingħata doża waħda ta' 0.5 ml.
English: Neisseria meningitidis group Y polysaccharide1
Maltese: Polysaccharide tal-grupp Y ta' Neisseria meningitidis
English: 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
Maltese: Tabella 12: (rSBA*) għal Nimenrix u l-vaċċin ACWY-PS f'adoloxxenti bejn l-età ta' 1117-il sena u adulti li għandhom ≥ 18-il sena xahar wara t-tilqim
English: Nimenrix MenCCRM vaccine W-135 Nimenrix
Maltese: Nimenrix 354 vaċċin MenC-CRM
English: Data from MenACWY-TT-083 support the extrapolation of the immunogenicity data and posology to infants from 12 weeks to less than 6 months of age.
Maltese: Dejta minn MenACWY-TT-083 tappoġġja l-estrapolazzjoni tad-dejta tal-immunoġeniċità u lpożoloġija għat-trabi minn età ta' 12-il ġimgħa sa inqas minn 6 xhur.
English: 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).
Maltese: Fis-sottogrupp ta' dawk li kellhom > 65 sena, il-perċentwal ta' individwi li kienu rċevew it-tilqim, li kellhom titri rSBA ≥ 128 xahar wara t-tilqim kien ivarja minn 90 % (grupp A) sa 97 % (grupp Y).
English: 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)
Maltese: Xahar 1 364 95.1% (92.3; 97.0) Sena 1 356 97.8% (95.
English: N ≥8 (95% CI)
Maltese: 8 (95% CI)
English: Nimenrix 89 ACWY-PS 32
Maltese: Il-vaċċin ACWY-PS
English: A single primary dose administered at 6 months of age elicited robust rSBA responses to groups A, C, W-135 and Y, as measured by the percentage of subjects with rSBA titres ≥8, that were comparable to responses after the last dose of a three-dose primary series.
Maltese: Doża primarja waħda li ngħatat f'età ta' 6 xhur irriżultat f'risponsi rSBA robusti għall-gruppi A, C, W-135 u Y, kif imkejla mill-perċentwal ta' individwi b'titri rSBA ≥8, li kienu komparabbli għar-risponsi wara l-aħħar doża ta' serje primarja ta' tliet dożi.
English: Table 4: Bactericidal antibody responses (rSBA*) in toddlers aged 12-23 months Menin gococc al
Maltese: Tabella 4: Risponsi ta' antikorpi batteriċida (rSBA*) fi tfal żgħar bejn l-età ta' 12-23 xahar Grupp
English: 1 month post-vaccination (study MenACWY-TT-027)
Maltese: Xahar wara t-tilqim (studju MenACWY-TT-027)
English: Robust anamnestic responses to the antigen(s) in the priming vaccine were observed.
Maltese: Ġew osservati risponsi anamnestiċi robusti għall-antiġen(i) fil-vaċċin tal-prajmjar.
English: EU/1/12/767/006 - pack of 10
Maltese: EU/1/12/767/006 - pakkett ta' 10
English: The safety and antibody persistence data up to year 5 and the data on co-administration of MenACWY-TT with Prevenar 13 will be provided in sequential study reports at 1, 3 and 5 years after vaccination.
Maltese: Id-dejta tas-sigurtà u tal-persistenza talantikorpi sa sena 5 u d-dejta dwar il-ko-amministrazzjoni ta' MenACWYTT bi Prevenar 13 se tiġi pprovduta f'rapporti ta' studju sekwenzjali ta' sena waħda, 3 snin u 5 snin wara t-tilqima.
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).
Maltese: L-għoti ta' Nimenrix xahar wara l-vaċċin ta' DTaP-HBV-IPV/Hib wassal għal GMTs ta' rSBA kontra gruppi A, C u W-135 aktar baxxi meta mqabbla ma' ko-amministrazzjoni (ara sezzjoni 4.5).
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).
Maltese: Effett ta' tilqima minn qabel b'vaċċin meningokokkali polysaccharide sempliċi Individwi li qabel kienu mlaqqma b'vaċċin tal-polysaccharide sempliċi tal-meningokokkus u li tlaqqmu b' Nimenrix bejn 30 u 42 xahar wara kellhom Titres Ġeometriċi Medji (Geometric Mean Titres (GMTs)) aktar baxxi meta tkejlu b'analiżi batteriċida tas-serum bl-użu tal-komplement tal-fenek (rabbit complement serum bactericidal assay (rSBA)) milli f'individwi li ma kien tlaqqmu bl-ebda vaċċin tal-meningokokkus fl-10 snin ta' qabel (ara sezzjoni 5.1).
English: Timepoint (Years)
Maltese: Punt ta' żmien (sena)
English: In the 6-12 weeks and in the 12-14 months age groups who received 2 doses of Nimenrix given 2 months apart, the first and second doses were associated with similar local and systemic reactogenicity.
Maltese: Fil-gruppi ta' etajiet ta' 6-12-il ġimgħa u ta' 12-14-il xahar li rċevew 2 dożi ta' Nimenrix mogħtija xahrejn minn xulxin, l-ewwel u t-tieni doża ġew assoċjati ma' reattoġeneċità lokali u sistemika simili.
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.
Maltese: F'individwi ta' bejn 9 u 25 sena, Nimenrix jista' jingħata flimkien ma' vaċċin tal-papillomavirus talbniedem [Tipi 16, 18], u vaċċin ikkombinat tad-difterite (kontenut tal-antiġen imnaqqas), tat-tetnu u tas-sogħla konvulsiva aċellulari.
English: Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y, even if they develop antibodies following vaccination with Nimenrix.
Maltese: Persuni b'defiċjenzi tal-kumpliment familjali (pereżempju, defiċjenzi ta' C5 jew C3) u persuni li jirċievu kuri li jinibixxu attivazzjoni tal-kumpliment terminali (pereżempju, eculizumab) jinsabu f'riskju miżjud għal marda invażiva kkawżawta minn gruppi A, C, W-135 u Y ta' Neisseria meningitidis anki jekk jiżviluppaw antikorpi wara tilqima b'Nimenrix.
English: Nimenrix will only protect against infections caused by the bacteria “Neisseria meningitidis” types A, C, W-135 and Y.
Maltese: Nimenrix jipproteġik biss kontra infezzjonijiet ikkawżati mill-batterji “Neisseria meningitidis” tat-tipi A, C, W-135 u Y.
English: No data are available beyond the age of 2 years.
Maltese: Ma hija disponibbli lebda dejta wara l-età ta' sentejn.
English: *rSBA testing performed at PHE laboratories in UK ** tested at GSK laboratories
Maltese: PHE fir-Renju Unit ** l-ittestjar sar fil-laboratorji ta' GSK
English: • swelling, pain and redness where the injection is given.
Maltese: • tħossok irritabbli • nefħa, uġigħ u ħmura fejn tingħata l-injezzjoni.
English: The analysis of immunogenicity was conducted on ATP cohort for immunogenicity.
Maltese: L-analiżi tal-immunoġeniċità saret fuq il-koorti ATP għall-immunoġeniċità.
English: Safety data have also been evaluated in a separate study, in which a single dose of Nimenrix was administered to 274 individuals aged 56 years and older.
Maltese: Fi studju separat, ġiet evalwata wkoll dejta tas-sigurtà, li fih ingħatat doża waħda ta' Nimenrix lil 274 individwu li kellhom minn 56 sena 'l fuq.
English: • 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
Maltese: • irċevejtu d-doża tagħkom aktar minn madwar sena ilu u tistgħu tkunu f'riskju ta' infezzjoni kkawżata minn Neisseria meningitidis tipi A, C, W-135 u Y
English: VR: vaccine response * tested at GSK laboratories Persistence of the immune response was evaluated up to 5 years after vaccination in adolescents primed in study MenACWY-TT-036 (Table 13).
Maltese: Il-persistenza tar-rispons immuni ġiet stmata sa 5 snin wara t-tilqim f'adoloxxenti li kienu tlaqqmu flistudju MenACWY-TT-036 (Tabella 13).
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.
Maltese: F'MenACWY-TT-087, it-trabi rċivew jew doża primarja waħda wara 6 xhur segwita minn doża booster wara 15-18-il xahar (DTPa-IPV/Hib u vaċċin konjugat pnewmokokkali 10-valent ingħataw flimkien fiż-żewġ punti ta' żmien tat-tilqima) jew tliet dożi primarji wara xahrejn, 4 u 6 xhur segwiti minn doża booster wara 15-18-il xahar.
English: Meningococcal Group
Maltese: Grupp Meningo kokkali
English: 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)
Maltese: Tabella 2: Risponsi ta' antikorpi batteriċida (rSBA* u hSBA**) fit-trabi wara żewġ dożi mogħtija xahrejn 'il bogħod minn xulxin u wara doża booster fl-età ta' 12-il xahar (Studju MenACWY-TT-083)
English: *rSBA testing performed at PHE laboratories in UK.
Maltese: *l-ittestjar b'rSBA sar fil-laboratorji
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]).
Maltese: Xahar wara l-għoti flimkien ma' vaċċin ikkombinat tat-tossojde tat-tetnu, tossojde tad-difterite mnaqqas u tas-sogħla konvulsiva aċellulari, adsorbit (Tdap) f'individwi ta' bejn 9 sa 25 sena, ġew osservati GMCs iktar baxxi għal kull antiġen tas-sogħla konvulsiva (tossojde tas-sogħla konvulsiva [PT, pertussis toxoid], emagglutinina filamentuża [FHA, filamentous haemagglutinin] u pertaktina [PRN]).
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
Maltese: Mhux magħruf: ma tistax tittieħed stima mid-data disponibbli • nefħa u ħmura tas-sit tal-injezzjoni; dan jista' jaffettwa erja kbira tad-driegħ imlaqqam
English: Post dose 1(1)
Maltese: NUMRU(I)
English: Pfizer Luxembourg SARL
Maltese: Pfizer BV
English: Table 11: 1 month post-vaccination and 1 year persistence data (hSBA*) in children 6-10 years of age
Maltese: Tabella 11: Dejta ta' xahar wara t-tilqim u ta' persistenza ta' sena (hSBA*) fi tfal bejn l-età ta' 6-10 snin
English: • septicaemia - an infection of the blood.
Maltese: • settiċemija - infezzjoni fid-demm.
English: In infants, Nimenrix can be given concomitantly with combined DTaP-HBV-IPV/Hib vaccines and with 10-valent pneumococcal conjugate vaccine.
Maltese: Fit-trabi, Nimenrix jista' jingħata fl-istess ħin ma' vaċċini kombinati tad-DTaP-HBV-IPV/Hib u ma', vaċċin pnewmokokkali konjugat 10-valenti.
English: This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery.
Maltese: Dan jista' jseħħ flimkien ma' diversi sinjali newroloġiċi bħal disturb temporanju fil-vista, paresteżija, u ċaqliq toniku kloniku taddirgħajn u r-riġlejn waqt li l-persuna tkun qed tistejqer.
English: Malaise
Maltese: LABRA
English: Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal group A, C, W-135 and Y conjugate vaccine
Maltese: Nimenrix trab u solvent għal soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Vaċċin konjugat tal-gruppi A, C, W-135 u Y tal-meningokokkus
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.
Maltese: Tilqima ta' rinforz b'Nimenrix f'individwi li ġew prajmjati b'monovalenti (MenC-CRM) jew vaċċin meningokokkali konjugat kwadrivalenti (MenACWY-TT) qabel, ġiet studjata fl-individwi kollha milletà ta' 12-il xahar 'il fuq li rċevew tilqima ta' rinforz.
English: The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for immunogenicity (1) blood sampling performed 21-48 days post vaccination *tested at Public Health England laboratories
Maltese: L-analiżi tal-immunoġeniċità saret skont il-koorti skont il-protokoll (ATP - according-to-protocol) għall-immunoġeniċità teħid ta' kampjuni tad-demm li saru 21-48 jum wara t-tilqima * ittestjati f'laboratorji ta' Public Health England
English: The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for immunogenicity (1) blood sampling performed 21-48 days post vaccination * tested at Public Health England laboratories
Maltese: L-analiżi tal-immunoġeniċità saret skont il-koorti skont il-protokoll (ATP - according-to-protocol) għall-immunoġeniċità teħid ta' kampjuni tad-demm li saru 21-48 jum wara t-tilqima *ittestjati f'laboratorji ta' Public Health England
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).
Maltese: Il-persistenza tar-rispons immuni ġiet stmata permezz ta' rSBA u hSBA sa 5 snin fi tfal li kienu tlaqqmu l-ewwel darba fl-istudju MenACWY-TT-027 (Tabella 8).
English: Response to Nimenrix in subjects previously vaccinated with a plain polysaccharide vaccine against Neisseria meningitidis
Maltese: Rispons għal Nimenrix f'individwi li qabel kienu tlaqqmu b'vaċċin b'polysaccharide sempliċi kontra Neisseria meningitidis
English: Post dose
Maltese: Wara doża
English: 10 vials: powder 10 pre-filled syringes: solvent 10 x 1 dose (0.5 ml)
Maltese: 10 siringi mimlijin għal-lest: solvent 10 x doża 1 (0.5 ml)
English: Пфайзер Люксембург САРЛ, Клон България Teл: +359 2 970 4333
Maltese: Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: + 421 2 3355 5500
English: The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for immunogenicity (1) blood sampling performed 21-48 days post vaccination *tested at GSK laboratories
Maltese: Wara doża 2 L-analiżi tal-immunoġeniċità saret skont il-koorti skont il-protokoll (ATP - according-to-protocol) għall-immunoġeniċità teħid ta' kampjuni tad-demm li saru 21-48 jum wara t-tilqima *ittestjati f'laboratorji ta' GSK
English: Insomnia Crying
Maltese: Insomnja Biki
English: In individuals from 1 year of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle (see sections 4.4 and 4.5).
Maltese: Għal xi individwi, doża primarja addizzjonali ta' Nimenrix tista' titqies bħala xierqa (ara sezzjoni 4.4).
English: Table 6: Bactericidal antibody responses (rSBA)* in toddlers aged 12-14 months Meningococcal
Maltese: Tabella 6: Risponsi għal antikorpi batteriċidali (rSBA)* fi tfal żgħar ta' bejn 12 u 14-il xahar
English: Y
Maltese: JIS
English: A 594 C 691
Maltese: C 691
English: Pfizer Kft Tel: +36 1 488 3700
Maltese: Tel: +36 1 488 3700
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
Maltese: Mhux komuni fit-trabi **Raxx seħħ bi frekwenza Komuni fit-trabi ***ADR identifikati wara t-tqegħid fis-suq
English: vaccine 121 97.5%
Maltese: 9) Sena 1 350 29.1% (24
English: Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.
Maltese: Nimenrix huwa indikat għal tilqim attiv ta' individwi mill-età ta' 6 ġimgħat kontra mard invażiv talmeningokokkus ikkawżat mill-gruppi A, C, W-135, u Y ta' Neisseria meningitidis.
English: Injection site induration Injection site pruritus Injection site warmth Injection site anaesthesia
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: Protection against meningococcal disease
Maltese: Protezzjoni kontra mard meningokokkali
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.
Maltese: F'MenACWY-TT-083, l-ewwel doża ngħatat fl-età ta' 6 sa 12-il xahar, it-tieni doża ngħatat wara intervall ta' xahrejn u t-tielet doża (booster) ingħatat fl-età ta' madwar 12-il xahar.
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.
Maltese: Fir-rigward tat-tnaqqis ta' antikorp kontra MenA jew MenC wara l-ewwel doża ta' Nimenrix fit-tfal ta' bejn 12 u 23 xahar, ara taħt Persistenza ta' titres talantikorpi batteriċidali tas-serum.
English: • Official batch release
Maltese: • diffikultà biex torqod
English: • itching
Maltese: • biki
English: Syringe cap
Maltese: Meningokokkali
English: • 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)
Maltese: • b'żieda ta' mill-anqas 4 darbiet fit-titres ta' rSBA minn qabel għal wara t-tilqim f'individwi li fil bidu kienu seropożittivi (jiġifieri, titre ta' rSBA ≥ 8 qabel it-tilqim)
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
Maltese: L-analiżi tal-immunoġeniċità saret fuq il-koorti ATP għall-immunoġeniċità. kampjuni tad-demm ittieħdu bejn 42 u 56 jum wara t-tilqim kampjuni tad-demm ittieħdu bejn 30 u 42 jum wara t-tilqim * l-ittestjar sar fil-laboratorji ta' GSK
English: organizačná zložka
Maltese: Organi
English: Effect of Nimenrix on anti-tetanus antibody concentrations
Maltese: Nimenrix qanqal risponsi batteriċidali kontra l-gruppi
English: 1 vial: powder 1 ampoule: solvent 1 dose (0.5 ml)
Maltese: kunjett 1: trab siringa 1 mimlija għal-lest: solvent 2 labriet doża 1 (0.5 ml)
English: Instructions for reconstitution of the vaccine with the solvent presented in ampoules:
Maltese: Istruzzjonijiet għar-rikostituzzjoni tal-vaċċin bis-solvent ippreżentatf'ampulli:
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).
Maltese: Trab f'kunjett (ħġieġ tat-tip I) b'tapp (gomma butyl) u solvent f'siringa mimlija għal-lest b'tapp (gomma butyl).
English: The analysis of immunogenicity was conducted on ATP cohort for persistence adapted for each time-point.
Maltese: L-analiżi tal-immunoġeniċità saret fuq il-koorti ATP għall-persistenza adattata għal kull punt ta' żmien.
English: Serum bactericidal activity was also measured using hSBA as a secondary endpoint.
Maltese: Tkejlet ukoll l-attività batteriċidali fis-serum permezz tal-hSBA bħala skop finali sekondarju.
English: Nimenrix is a vaccine which helps protect against infections caused by bacteria (germs) called “Neisseria meningitidis" types A, C, W-135 and Y. “Neisseria meningitidis" types A, C, W-135 and Y bacteria can cause serious illnesses such as:
Maltese: Il-batterji “Neisseria meningitidis” tat-tipi A, C, W-135 u Y jistgħu jikkawżaw mard serju bħal:
English: The response against group C was non-inferior to the one elicited by licensed MenC-CRM and MenC-TT vaccines in terms of percentages with rSBA titres ≥8 at one month after the second dose.
Maltese: Ir-rispons kontra l-grupp C ma kienx inferjuri għal dak prodott mill-vaċċini lliċenzjati MenC-CRM u MenC-TT f'termini ta' perċentwali b'titres rSBA ta' ≥8, xahar wara t-tieni doża.
English: Package leaflet: Information for the user Nimenrix powder and solvent for solution for injection in ampoule
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Maltese: Studji fl-annimali ma jurux effetti ħżiena diretti jew indiretti fuq il-fertilità.
English: Nimenrix will be given to you by a doctor or nurse.
Maltese: Nimenrix se jingħatalek minn tabib jew infermier.
English: titre ≥8) was observed against all groups (A, C, W-135, Y) in all subjects regardless of the meningococcal vaccine history.
Maltese: Rispons immuni (titre ta' rSBA ≥8) deher kontra l-gruppi kollha (A, C, W-135, Y) fl-individwi kollha kienet x'kienet l-istorja ta' tilqim tal-meningokokkus.
English: Table 5: Bactericidal antibody responses (hSBA*) in toddlers aged 12-23 months Meningococcal
Maltese: Risponsi ta' antikorpi batteriċida (hSBA*) fi tfal żgħar bejn l-età ta' 12-23 xahar Grupp
English: Package leaflet: Information for the user Nimenrix powder and solvent for solution for injection in pre-filled syringe
Maltese: Kisser il-parti ta' fuq tal-ampulla, iġbed is-solvent b'siringa u żid is-solvent mat-trab.