FrancophonIA/ELRC3.0 huggingface dataset:
English: Nimenrix 2 doses
Maltese: Nimenrix 2 dożi
English: Similar responses in terms of % with hSBA titre ≥8 were observed with groups A and C (Table 7).
Maltese: Risponsi simili f'termini ta' % b'titre ta' hSBA ≥8 ġew osservati bi gruppi A u C (Tabella 7).
English: Primary immunisation
Maltese: Immunizzazzjoni primarja
English: Study MenACWYTT-035 (18-55 years)
Maltese: Studju MenACWYTT-035 (18-55 sena)
English: Pfizer Tél +33 1 58 07 34 40
Maltese: Tél +33 1 58 07 34 40
English: Pfizer PFE, spol.
Maltese: Česká Republika Pfizer PFE,spol.
English: Nimenrix 1 dose
Maltese: Nimenrix 1 doża
English: Name and address of the manufacturers of the biological active substance GlaxoSmithKline Biologicals S.A.
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bijoloġika attiva GlaxoSmithKline Biologicals S.A.
English: Nimenrix MenC-CRM vaccine 116
Maltese: Nimenrix vaċċin MenC-CRM 116
English: • rash (infants).
Maltese: • raxx (trabi).
English: Booster doses
Maltese: Dożi booster
English: Pfizer ApS Tlf: + 45 44 201 100
Maltese: Danmark Pfizer ApS Tlf: + 45 44 201 100
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 16 February 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' April 2012 Data tal-aħħar tiġdid: 16 ta' Frar 2017
English: Pack sizes of 1, 10 and 100
Maltese: Daqsijiet tal-pakkett ta' 1, 10 jew 100
English: Children (2-17 years) with anatomical or functional asplenia
Maltese: Tfal (2-17-il sena) b'asplenja anatomika jew funzjonali
English: Study MenACWYTT-036 (11-17 years)
Maltese: Studju MenACWYTT-036 (11-17-il sena
English: Very common Irritability Uncommon
Maltese: Komuni ħafna Irritabilità Mhux komuni
English: Table 1 Tabulated summary of adverse reactions by system organ class System Organ Class
Maltese: Tabella 1 Sommarju f'tabella tar-reazzjonijiet avversi skont is-sistema tal-klassifika tal-organi Klassi tas-Sistemi u tal
English: Meningococcal Group rSBA*
Maltese: Grupp Meningo kokkali rSBA*
English: Adverse reactions reported in subjects aged >55 years were similar to those observed in younger adults.
Maltese: Ir-reazzjonijiet avversi rrappurtati f'individwi ta' >55 sena kienu simili għal dawk osservati f'persuni adulti iżgħar fl-età.
English: Adverse reactions reported are listed according to the following frequency categories:
Maltese: Reazzjonijiet avversi li ġew irrappurtati huma elenkati skont il-kategoriji ta' frekwenza li ġejjin:
English: Immunodeficiency
Maltese: Immunodefiċjenza
English: Powder for Nimenrix MenACWY Conjugate IM
Maltese: Trab għal Nimenrix MenACWY Konjugat IM
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).
Maltese: Fi studju separat (MenACWY-TT-085), doża unika ta' Nimenrix ingħatat lil 194 adult Lebaniż li kellhom aktar minn 56 sena (fosthom 133 bejn l-età ta' 56-65 sena u 61 li kellhom > 65 sena).
English: Pharmacotherapeutic group: vaccines, meningococcal vaccines, ATC code: J07AH08
Maltese: Kategorija farmakoterapewtika: vaċċini, vaċċini tal-meningokokkus, Kodiċi ATC:
English: Persistence of immunogenicity was analysed using the year 5 ATP cohort.
Maltese: Il-persistenza tal-immunoġeniċità ġiet analizzata permezz tal-koorti ATP tas-sena 5.
English: Trometamol Sodium chloride Water for injections
Maltese: Trometamol Sodium chloride Ilma għall-injezzjonijiet
English: In study MenACWY-TT-039, serum bactericidal activity was also measured using hSBA as a secondary endpoint (Table 5).
Maltese: Fi studju MenACWY-TT-039, attività batteriċida fis-serum tkejlet ukoll permezz tal-hSBA bħala skop finali sekondarju (Tabella 5).
English: EU/1/12/767/001 - pack of 1 without needle EU/1/12/767/002 - pack of 10 without needle EU/1/12/767/003 - pack of 1 with 2 needles EU/1/12/767/004 - pack of 10 with 20 needles
Maltese: EU/1/12/767/001 - pakkett ta' 1 mingħajr labra EU/1/12/767/002 - pakkett ta' 10 mingħajr labra EU/1/12/767/003 - pakkett ta' 1 b'żewġ labriet EU/1/12/767/004 - pakkett ta' 10 b'20 labra
English: The percentage of subjects with rSBA titres (measured at GSK's laboratories) ≥128 before vaccination ranged from 45% (group C) to 62% (group Y).
Maltese: Ilperċentwal ta' individwi b'titri rSBA (imkejla fil-laboratorji ta' GSK) ≥ 128 qabel it-tilqim kien ivarja minn 45 % (grupp C) sa 62 % (grupp Y).
English: Immunogenicity in children aged 2-10 years
Maltese: Immunoġeniċità fi tfal bejn l-età ta' 2-10 snin
English: Thrombocytopenia and coagulation disorders
Maltese: Tromboċitopenija u disturbi fil-koagulazzjoni
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
Maltese: Dejta ta' xahar wara t-tilqim (Studju MenACWY-TT-052) u ta' persistenza ta' 5 snin (Studju MenACWY-TT-059) (hSBA*) f'adoloxxenti u adulti bejn l-età ta' 11-25 sena
English: Very common: (≥1/10) Common:
Maltese: Komuni ħafna: (≥1/10) Komuni:
English: This total included 3,079 toddlers (12 months to 23 months), 909 children between 2 and 5 years of age, 990 children between 6 and 10 years of age, 2,317 adolescents (11 to 17 years) and 2,326 adults (18 to 55 years).
Maltese: Dan it-total kien jinkludi 3,079 tifel u tifla żgħar (12-il xahar sa 23 xahar), 909 tifel u tifla ta' bejn sentejn u 5 snin, 990 tifel u tifla ta' bejn 6 u 10 snin, 2,317-il adoloxxent (11 sa 17-il sena) u 2,326 adult (18 sa 55 sena).
English: N VR (95% CI)
Maltese: VR (95% CI)
English: 1 year persistence (study MenACWY-TT-028)
Maltese: Persistenza ta' sena (studju MenACWY-TT-028)
English: Two clinical studies have been conducted in infants, MenACWY-TT-083 and MenACWY-TT-087.
Maltese: Saru żewġ studji kliniċi fit-trabi, MenACWY-TT-083 u MenACWY-TT-087.
English: Study (Age range)
Maltese: Studju (Medda taletà)
English: • A pooled analysis of data from 9,621 subjects administered a single dose of Nimenrix.
Maltese: • Analiżi miġbura ta' dejta minn 9,621 individwu mogħtija doża waħda ta' Nimenrix.
English: Nimenrix elicited a bactericidal antibody response against the four meningococcal groups.
Maltese: Nimenrix qanqal rispons ta' antikorpi batteriċida kontra l-erba' gruppi meningokokkali.
English: Vaccine group rSBA*
Maltese: Grupp talvaċċin rSBA*
English: * tested at GSK laboratories
Maltese: * l-ittestjar sar fil-laboratorji ta' GSK
English: Nimenrix is available in packs of 1, 10 or 100.
Maltese: Nimenrix huwa disponibbli f'pakketti ta' 1, 10 jew ta' 100.
English: 10 vials: powder 10 pre-filled syringes: solvent 20 needles
Maltese: 10 siringi mimlijin għal-lest: solvent 20 labra
English: • bruising (haematoma) where the injection is given
Maltese: • tbenġil (ematoma) fejn tingħata l-injezzjoni
English: Neisseria meningitidis group W-135 polysaccharide1
Maltese: Polysaccharide tal-grupp W-135 ta' Neisseria meningitidis
English: Timing
Maltese: TIKKETTAR
English: Pruritus Rash**
Maltese: Ħakk Raxx**
English: In individuals aged 9 to 25 years, Nimenrix can be given concomitantly with human papillomavirus bivalent [Type 16 and 18] vaccine, recombinant (HPV2).
Maltese: F'individwi ta' bejn 9 u 25 sena, Nimenrix jista' jingħata flimkien ma' vaċċin bivalenti talpapillomavirus tal-bniedem [Tip 16 u 18], rikombinanti (HPV2).
English: Trometamol Solvent:
Maltese: Sucrose Trometamol
English: The analysis of immunogenicity was conducted on the primary according-to-protocol (ATP) cohort for immunogenicity.
Maltese: L-analiżi tal-immunoġeniċità saret fuq il-koorti primarju skont il-protokoll (ATP) għall-immunoġeniċità.
English: After reconstitution, 1 dose (0.5 ml) contains 5 micrograms of Neisseria meningitidis group A, C, W135 and Y polysaccharides.
Maltese: Wara r-rikostituzzjoni, doża 1 (0.5 ml) jkun fiha 5 mikrogrammi ta' polysaccharides tal-gruppi A, C, W-135 u Y ta' Neisseria meningitidis.
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.
Maltese: F'żewġ studji kliniċi, li saru f'adoloxxenti bejn l-età ta' 11-17-il sena (studju MenACWY-TT-036) u f'adulti bejn l-età ta' 18-55 sena (studju MenACWY-TT-035), ingħataw doża waħda ta' Nimenrix jew doża waħda tal-vaċċin ACWY-PS.
English: Although delay is not recommended, stability has been demonstrated for 8 hours at 30°C after reconstitution.
Maltese: Għalkemm mhuwiex irrakkomandat dewmien, intweriet stabbilità għal 8 sigħat f'temperatura ta' 30°C wara r-rikostituzzjoni.
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).
Maltese: Xahar wara l-għoti flimkien ma' vaċċin konjugat pnewmokokkali 10-valent, kienu osservati konċentrazzjonijiet Ġeometriċi Medji (Geometric Mean Concentrations (GMCs)) ta' antikorpi u GMTs ta' antikorpi minn analiżi opsonofagositika (opsonophagocytic assay (OPA)) aktar baxxi għal serotip pnewmokokkali wieħed (18C konjugat ma' proteina ġarriera tat-toxoid tat-tetnu).
English: 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).
Maltese: Il-persistenza tar-rispons immuni kienet stmata permezz ta' hSBA sa 5 snin wara t-tilqim f'adoloxxenti u adulti li kienu tlaqqmu l-ewwel darba f'MenACWY-TT-052 (Tabella 14) (ara sezzjoni 4.4).
English: • The other ingredients are: - In the powder: sucrose and trometamol - In the solvent: sodium chloride and water for injections
Maltese: - Fit-trab: sucrose u trometamol - Fis-solvent: sodium chloride u ilma għall-injezzjonijiet
English: Powder in a vial (type I glass) with a stopper (butyl rubber) and solvent in an ampoule (type I glass).
Maltese: Trab f'kunjett (ħġieġ tat-tip I) b'tapp (gomma butyl) u solvent f'ampulla (ħġieġ tat-tip I).
English: Persistence of serum bactericidal antibody titres
Maltese: Il-persistenza tat-titres tal-antikorpi batteriċidali fis-serum
English: • rSBA titres ≥32 for initially seronegative subjects (i.e., pre-vaccination rSBA titre <8)
Maltese: • b'titres ta' rSBA  32 għal individwi li fil-bidu kienu seronegattivi (jiġifieri, titre ta' rSBA < 8
English: Infants from 6 months of age, children, adolescents and adults One injection.
Maltese: Trabi minn età ta' 6 xhur, tfal, adolexxenti u adulti:
English: Table 1 shows the adverse reactions reported from the studies in subjects aged from 6 weeks up to 55 years of age and post-marketing experience.
Maltese: Tabella 1 turi r-reazzjonijiet avversi trappurtati mill-istudji f'individwi mill-etajiet ta' 6 ġimgħat sa 55 sena u mill-esperjenza ta' wara t-tqegħid fis-suq.
English: The rSBA GMTs were significantly lower in the subjects who had received a dose of ACWY-PS vaccine 30-42 months prior to Nimenrix, however 100% of subjects achieved rSBA titers ≥8 for all four meningococcal groups (A, C, W-135, Y) (see section 4.4).
Maltese: Il-GMTs ta' rSBA kienu anqas b'mod sinifikanti fl-individwi li kienu rċivew doża tal-vaċċin ACWY-PS minn 30-42 xahar qabel Nimenrix, madankollu, 100 % tal-individwi kisbu titers ta' rSBA ≥8 għall-erba' gruppi meningokokkali kollha (A, C, W-135, Y) (ara sezzjoni 4.4).
English: Nimenrix elicited bactericidal responses against all four groups that were similar in terms of % with rSBA titre ≥8 and GMT after one or two doses (Table 6).
Maltese: Nimenrix qanqal risponsi batteriċidali kontra l-erba' gruppi li kienu simili f'termini ta' % b'titre ta' rSBA ≥8 u GMT wara doża waħda jew tnejn (Tabella 6).
English: Study MenACWY-TT-104(1)
Maltese: Studju MenACWY-TT-104
English: Table 8: 5 years persistence data in toddlers aged 12-23 months at vaccination (study MenACWY-TT-032; extension of study 027)
Maltese: Tabella 8: Dejta ta' persistenza ta' 5 snin fi tfal żgħar li kellhom etajiet bejn 12-23 xahar meta tlaqqmu (studju MenACWY-TT-032; estensjoni tal-istudju 027)
English: Neisseria meningitidis group C polysaccharide1
Maltese: Polysaccharide tal-grupp C ta' Neisseria meningitidis
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)].
Maltese: Fl-istudju MenACWY-TT-081, Nimenrix intwera li ma kienx inferjuri għal vaċċin liċenzjat ieħor MenC-CRM f'termini ta' rispons tal-vaċċin għall-grupp C [94.8 % (95 % CI: 91.4; 97.1) u 95.7 % (95 % CI: 89.2; 98.8) rispettivament].
English: EU/1/12/767/007 - pack of 100
Maltese: EU/1/12/767/007 - pakkett ta' 100
English: 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.
Maltese: Effett ta' antikorpi ta' qabel it-tilqima kontra t-tossojde tat-tetnu Is-sigurtà u l-immunoġeniċità ta' Nimenrix kienu stmati meta ngħata wara, jew flimkien ma' vaċċin li kien fih, tossojdi tad-difterite u tat-tetnu, sogħla konvulsiva aċellulari, poljovirusijiet inattivati (1, 2 u 3), antiġen tal-wiċċ tal-epatite B u polyribosyl ribose phosphate tal-Haemophilus influenzae tat-tip b konjugat mat-tossojde tat-tetnu (DTaP-HBV-IPV/Hib) fit-tieni sena tal-ħajja.
English: Table 13: 5 years persistence data (rSBA*) in adolescents aged 11-17 years at vaccination Menin gococc al
Maltese: Tabella 13: Dejta ta' persistenza ta' 5 snin (rSBA*) f'adoloxxenti li kellhom etajiet bejn 1117-il sena meta tlaqqmu
English: A booster dose produced robust responses, comparable between the two dosing groups, against all four meningococcal groups.
Maltese: Doża booster ipproduċiet risponsi robusti, komparabbli bejn iż-żewġ gruppi tad-dożaġġ, kontra l-erba' gruppi meningokokkali kollha.
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.
Maltese: Studju MenACWY-TT-084 qabbel ir-risponsi immuni għal żewġ dożi ta' Nimenrix mogħtija xahrejn minn xulxin bejn 43 individwu li kellhom bejn sentejn u 17-il sena b'asplenja anatomika jew funzjonali u 43 individwu mqabblin fl-età b'funzjoni splenika normali.
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.
Maltese: Nimenrix jinduċi l-produzzjoni ta' antikorpi batteriċida kontra l-polysaccharides tal-kapsula ta' Neisseria meningitidis tal-gruppi A, C, W-135 u Y meta jitkejlu b'analiżi li tuża jew l-rSBA jew l-hSBA.
English: VR: vaccine response defined as the proportion of subjects with:
Maltese: VR: rispons għall-vaċċin definit bħala l-proporzjon ta' individwi:
English: Table 10: 44 months persistence data in children 2-10 years of age at vaccination (Study MenACWY-TT-088; extension of study 081)
Maltese: Dejta ta' persistenza ta' 44 xahar fi tfal b'età minn sentejn sa 10 snin meta tlaqqmu (Studju MenACWY-TT-088; estensjoni tal-istudju 081)
English: Syringe barrel
Maltese: Għatu tas-siringa
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).
Maltese: Il-persistenza tar-rispons immuni kienet stmata permezz ta' hSBA sena wara t-tilqim fi tfal li kellhom bejn 6-10 snin li kienu tlaqqmu l-ewwel darba fl-istudju MenACWY-TT-027 (Tabella 11) (ara sezzjoni 4.4).
English: *rSBA testing performed at Public Health England (PHE) laboratories in UK **hSBA tested at GSK laboratories blood sampling performed 21 to 48 days post vaccination
Maltese: *l-ittestjar tal-rSBA sar fil-laboratorji ta' Public Health England (PHE) fir-Renju Unit **l-ittestjar tal-hSBA sar fil-laboratorji ta' GSK kampjuni tad-demm ittieħdu 21 sa 48 jum wara t-tilqim
English: • aching muscles
Maltese: • uġigħ fil-muskoli
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
Maltese: *l-ittestjar tal-rSBA sar fil-laboratorji ta' Public Health England (PHE) fir-Renju Unit **l-ittestjar tal-hSBA sar f'Neomed, Laval, il-Kanada kampjuni tad-demm ittieħdu xahar wara t-tilqim
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.
Maltese: Mill-età ta' sena 'l fuq, Nimenrix jista' jingħata flimkiem ma' kwalunkwe wieħed minn dan it-tilqim li ġej: vaċċini tal-epatite A (hepatitis A vaccine (HAV)) u tal-epatite B (hepatitis B vaccine (HBV)), vaċċin tal-ħosba, tal-gattone u tal-ħosba Ġermaniża (measles - mumps - rubella (MMR) vaccine), vaċċin tal-ħosba, tal-gattone, tal-ħosba Ġermaniża u tal-ġidri r-riħ (measles - mumps - rubellavaricella (MMRV) vaccine), vaċċin konjugat pnewmokokkali 10-valent jew vaċċin mhux awżiljat talinfluwenza tal-istaġun.
English: Study MenACWY-TT-039(1)
Maltese: Studju MenACWY-TT-039
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.
Maltese: Fi studju MenACWY-TT-021 li sar f'individwi bejn l-eta ta' 4.5-34 sena, l-immunoġeniċità ta' Nimenrix mogħti bejn 30 u 42 xahar wara t-tilqim b'vaċċin ACWY-PS tqabblet mal-immunoġeniċità ta' Nimenrix mogħti lil individwi mqabblin fl-età li ma kienu mlaqqmin bl-ebda vaċcin talmeningokokkus fl-10 snin ta' qabel.
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)
Maltese: Tabella 3: Risponsi ta' antikorpi batteriċida (rSBA* u hSBA**) fit-trabi wara doża waħda mogħtija f'età ta' 6 xhur u wara doża booster fl-età ta' 15-18-il xahar (Studju MenACWY-TT
English: Pfizer BV Tel: +31 (0)10 406 43 01
Maltese: Tel: +31 (0)10 406 43 01
English: DTaP-HBV-IPV/Hib and a 10-valent pneumococcal vaccine were co-administered.
Maltese: DTaP-HBVIPV/Hib u vaċċin pnewmokokkali 10-valenti ngħataw flimkien.
English: After completion of the primary immunisation course in infants 6 weeks to less than 12 months of age, a booster dose should be given at 12 months of age with an interval of at least 2 months after the last Nimenrix vaccination (see section 5.1).
Maltese: Wara t-tmiem tal-kors ta' immunizzazzjoni primarja fi trabi ta' età ta' 6 ġimgħat sa inqas minn 12il xahar, għandha tingħata doża booster f'età ta' 12-il xahar b'intervall ta' mill-inqas xahrejn wara laħħar tilqima ta' Nimenrix (ara sezzjoni 5.1).
English: 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)
Maltese: Xahar 1 334 91.0% (87.4; 93.9) Sena 1 327 98.5% (96.5; 99.5)
English: 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)
Maltese: Tabella 9: (rSBA*) għal Nimenrix u l-vaċċin ACWY-PS fi tfal bejn l-età ta' 2-10 snin xahar wara t-tilqim (studju MenACWY-TT-038)
English: In clinical studies MenACWY-TT-039 and MenACWY-TT-040 a single dose of Nimenrix elicited rSBA responses against the four meningococcal groups, with a response against group C that was comparable to the one elicited by the licensed MenC-CRM vaccine in terms of percentages with rSBA
Maltese: Fi studji kliniċi MenACWY-TT-039 u MenACWY-TT-040, doża waħda ta' Nimenrix siltet risponsi ta' rSBA kontra l-erba' gruppi meningokokkali, b'rispons kontra l-grupp C li kien kumparabbli ma' dak li nstilet bil-vaċċin liċenzjat MenC-CRM f'termini ta' perċentwali b'titres ta' rSBA ≥8 (Tabella 4).
English: Overall, at one month post-vaccination the percentage of vaccines with rSBA titres ≥ 128 ranged from 93% (group C) to 97% (group Y).
Maltese: B'mod ġenerali, xahar wara t-tilqim, il-perċentwal ta' individwi li kienu rċevew it-tilqim, li kellhom titri rSBA ≥ 128 kien ivarja minn 93 % (grupp C) sa 97 % (grupp Y).
English: More than 98% of subjects had anti-PT, FHA or PRN concentrations above the assay cut-off thresholds.
Maltese: Aktar minn 98 % tal-individwi kellhom konċentrazzjonijiet kontra PT, FHA jew PRN ta' aktar mil-limiti tal-cut-off tal-assaġġ.
English: After reconstitution, 1 dose (0.5 ml) contains: Neisseria meningitidis group A polysaccharide1
Maltese: - Wara r-rikostituzzjoni, doża waħda (0.5 ml) jkun fiha: Polysaccharide tal-grupp A ta' Neisseria meningitidis
English: ≥1:8 and ≥1:128 and hSBA titres ≥1:4 and ≥1:8.
Maltese: Xahar wara l-ewwel doża talvaċċin u xahar wara t-tieni doża, perċentwali simili tal-individwi fiż-żewġ gruppi kellhom titri rSBA ≥1:8 u ≥1:128 u titri hSBA ≥1:4 u ≥1:8.
English: Immunogenicity in toddlers aged 12-23 months
Maltese: Immunoġeniċità fi tfal żgħar b'età ta' 12-23 xahar
English: Other medicines and Nimenrix
Maltese: Mediċini oħra u Nimenrix
English: 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)
Maltese: .4; 34.2) Sena 5 141 48.9 % (40.4; 57.5)
English: Pfizer Luxembourg SARL,
Maltese: Pfizer Luxembourg SARL Eesti filiaal Tel.:
English: Study MenACWY-TT-040(2)
Maltese: Studju MenACWY-TT-040
English: 100 vials: powder 100 ampoules: solvent 100 x 1 dose (0.5 ml)
Maltese: 100 kunjett: trab 100 ampulla: solvent 100 x doża 1 (0.5 ml)
English: Anti-capsular meningococcal antibodies protect against meningococcal diseases via complement mediated bactericidal activity.
Maltese: Antikorpi kontra l-kapsula tal-meningokokkus jipproteġu kontra mard tal-meningokokkus permezz ta' attività batteriċida medjata mill-komplement.
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).
Maltese: Fl-istudju MenACWY-TT-038, Nimenrix intwera li ma kienx inferjuri għal vaċċin liċenzjat ACWYPS f'termini ta' rispons tal-vaċċin għall-erba' gruppi (A, C, W-135 u Y) (Ara Tabella 9).
English: Menin gococc al Group
Maltese: Grupp Menin gokok kali
English: EU/1/12/767/005 - pack of 1
Maltese: EU/1/12/767/005 - pakkett ta' 1
English: 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.
Maltese: Fit-tieni sena tal-ħajja, Nimenrix jista' jingħata wkoll fl-istess waqt ma' tilqim ikkombinat taddifterite, tat-tetnu u tas-sogħla konvulsiva aċellulari (DTaP) inkluż il-kombinazzjoni tat-tilqim DTaP mal-epatite B, il-poljovirus inattivat jew il-Haemophilus influenzae tat-tip b (HBV, IPV jew Hib), bħat-tilqima DTaP-HBV-IPV/Hib) u l-vaċċin konjugat pnewmokokkali 13-il valent.