FrancophonIA/ELRC3.0 huggingface dataset:
English: Both groups showed a robust response to the booster dose of Menveo at one month after vaccination (100% of subjects had hSBA ≥ 1:8 across serogroups) and this response largely persisted through 2 years after the booster dose for serogroups C, W-135 and Y (with 87% to 100% of subjects with hSBA ≥ 1:8 across serogroups).
Slovenian: V obeh skupinah je bil odziv na poživitveni odmerek cepiva Menveo zanesljiv po enem mesecu po cepljenju (pri 100 % oseb je bil hSBA ≥ 1:8 za vse seroskupine); ta odziv je pri seroskupinah C, W-135 in Y (87 % do 100 % oseb s hSBA ≥ 1:8 v vseh skupinah) večinoma ostal tudi 2 leti po poživitvenem odmerku.
English: 12 months post-vaccination hSBA ≥1:8
Slovenian: 12 mesecev po cepljenju hSBA ≥1:8
English: Common: nausea, vomiting, diarrhea
Slovenian: Pogosti: navzea, bruhanje, driska Bolezni kože in podkožja:
English: In the subset of subjects aged 11-18 years who were seronegative at baseline (hSBA < 1:4), the proportion of subjects who achieved a hSBA ≥ 1:8 after a dose of Menveo were as follows: serogroup A 75% (780/1039); serogroup C 80% (735/923); serogroup W-135 94% (570/609); serogroup Y 81% (510/630).
Slovenian: Pri osebah, starih 11-18 let, ki so bile ob izhodišču seronegativne (hSBA <1:4), je bil delež oseb, ki so po prvem odmerku cepiva Menveo dosegle hSBA ≥ 1:8, kot sledi: seroskupina A 75 % (780/1039); seroskupina C 80 % (735/923); seroskupina W-135 94 % (570/609); seroskupina Y 81 % (510/630).
English: At 7 days post vaccination, 64% of subjects achieved hSBA ≥1:8 against serogroup A and 88% through 90% of subjects had bactericidal antibodies against serogroups C, W-135 and Y. At one month post vaccination, 92% through 98% of subjects had hSBA ≥1:8 against serogroups A, C, W-135 and Y. A robust immune response as measured by hSBA GMTs against all serogroups was also observed at 7 days (GMTs 34 through 70) and 28 days (GMTs 79 through 127) after a single dose vaccination.
Slovenian: 7 dni po cepljenju je 64 % oseb doseglo hSBA ≥ 1 : 8 proti seroskupini A in 88 % do 90 % oseb je imelo baktericidna protitelesa proti seroskupinam C, W-135 in Y. Po enem mesecu po cepljenju je imelo 92 % do 98 % oseb hSBA ≥ 1 : 8 proti seroskupinam A, C, W-135 in Y. Opazili so tudi zanesljiv imunski odziv, merjen z GMT hSBA proti vsem seroskupinam, po 7 dneh (GMT 34 do 70) in 28 dneh (GMT 79 do 127) po cepljenju z enkratnim odmerkom.
English: Individuals 11 to 65 years of age
Slovenian: Pri osebah, starih 19-55 let,
English: In the 11-18 year old population of the pivotal study, V59P13, the immunogenicity of a single dose of Menveo one month post vaccination is compared with the ACWY-D. Immunogenicity results at one month after Menveo are summarized below in Table 4.
Slovenian: V populaciji, stari 11-18 let, so v osrednji študiji V59P13 primerjali imunogenost enojnega odmerka cepiva Menveo en mesec po cepljenju z ACWY-D.
English: Separate injection sites must be used if more than one vaccine is being administered at the same time.
Slovenian: Če se sočasno aplicira več kot eno cepivo, je treba izbrati ločeni mesti injiciranja.
English: N=42 N=49 N=49
Slovenian: N=42 N=49 N=49 N=42
English: The powder is a white to off- white cake.
Slovenian: Bela do belkasta pogača praška.
English: At 1 year post last vaccination, the percentages of subjects with hSBA ≥1:8 after the 2-dose series and the single dose were both lower than at 1 month post-vaccination (30% after the 2-dose series, 11%20% after the single dose for serogroup A; 61%-81% and 41%-55% for serogroup C; 92%-94% and 90%-91% for serogroup W-135; 67%-75% and 57%-65% for serogroup Y).
Slovenian: Eno leto po zadnjem cepljenju so bili odstotki oseb s hSBA ≥ 1:8 po seriji z dvema odmerkoma in z enkratnim odmerkom v obeh skupinah nižji kot en mesec po cepljenju (30 % po seriji z dvema odmerkoma, 11 %-20 % po enkratnem odmerku pri seroskupini A; 61 %-81 % in 41 %-55 % pri seroskupini C; 92 %-94 % in 90 %-91 % pri seroskupini W-135; 67 %-75 % in 57 %-65 % pri seroskupini Y).
English: Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years
Slovenian: Tabela 4: Odzivi baktericidnih protiteles v serumu en mesec po cepljenju s cepivom Menveo pri osebah, starih 11-18 let
English: Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 2-5 years and 6-10 years
Slovenian: Tabela 1: Odzivi baktericidnih protiteles v serumu en mesec po cepljenju s cepivom Menveo pri osebah, starih 2-5 let in 6-10 let
English: Potassium dihydrogen phosphate
Slovenian: Prašek saharoza kalijev dihidrogenfosfat
English: Each dose of Menveo is supplied as a: - 1 Vial containing the MenA Lyophilised Conjugate Component as a white to off-white powder - 1 Vial containing the MenCWY Liquid Conjugate Component as clear solution - Pack size of one dose (2 vials) or five doses (10 vials).
Slovenian: Vsak odmerek cepiva Menveo je na voljo kot: - 1 viala, ki vsebuje komponento liofiliziranega konjugata MenA kot bel do belkast prašek
English: Musculoskeletal and connective tissue disorders: Common: myalgia, arthralgia General disorders and administration site conditions:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva: Pogosti: mialgija, artralgija
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: In the subset of subjects aged 19-55 years who were seronegative at baseline, the proportion of subjects who achieved a hSBA ≥ 1:8 after a dose of Menveo were as follows: serogroup A 67% (582/875); serogroup C 71% (401/563); serogroup W135 82% (131/160); serogroup Y 66% (173/263).
Slovenian: ki so bile ob izhodišču seronegativne, je bil delež oseb, ki so po prvem odmerku cepiva Menveo dosegle hSBA ≥ 1:8, kot sledi: seroskupina A 67 % (582/875); seroskupina C 71 % (401/563); seroskupina W-135 82 % (131/160); seroskupina Y 66 % (173/263).
English: The solution is a colourless clear solution.
Slovenian: Raztopina je brezbarvna bistra raztopina.
English: N=41 N=49 N=49
Slovenian: N=41 N=49 N=49 N=41
English: Overall 3464 subjects aged 2 to10 years were exposed to Menveo in completed clinical trials.
Slovenian: V zaključenih kliničnih študijah je bilo cepivo Menveo uporabljeno pri skupno 3.464 osebah,
English: Table 9: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years
Slovenian: Tabela 9: Odzivi baktericidnih protiteles v serumu en mesec po cepljenju s cepivom Menveo pri osebah, starih 19-55 let
English: The characterization of the safety profile of Menveo in children 2 to 10 years of age is based on data from four clinical trials in which 3181 subjects received Menveo.
Slovenian: temelji na podatkih štirih kliničnih študij, v katerih je bilo s cepivom Menveo cepljenih 3.181 oseb.
English: There are limited data in individuals aged 56-65 and there are no data in individuals aged >65 years.
Slovenian: Pri odraslih, starih med 56 in 65 let, je na voljo le malo podatkov, za odrasle, starejše od 65 let, pa podatkov ni.
English: Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Slovenian: Menveo prašek in raztopina za raztopino za injiciranje Konjugirano cepivo proti meningokokom skupin A, C, W-135 in Y
English: Your doctor will tell you if you need an additional injection of Menveo.
Slovenian: Povedal vam bo, če se morate cepiti še enkrat.
English: Currently available data are not sufficient to establish the efficacy of Menveo in children under 2 years of age.
Slovenian: Trenutno razpoložljivi podatki ne zadostujejo za dokaz učinkovitosti cepiva
English: The two primary safety studies were randomised, active-controlled trials that enrolled participants aged 11 to 55 years (N=2663) and 19 to 55 years (N=1606), respectively.
Slovenian: V eno so bile vključene osebe, stare 11 do 55 let (n = 2663) in v drugo osebe,
English: Uncommon: dizziness, injection site itching
Slovenian: Občasni: omotica, srbenje na mestu injiciranja
English: Immune system disorders
Slovenian: - imate oslabljen imunski sistem.
English: A booster dose of Menveo was administered 5 years after primary vaccination with Menveo or ACWY-PS. At 7 days after the booster dose, 98%-100% of subjects who previously received Menveo and 73%-84% of subjects who previously received ACWY-PS achieved hSBA ≥1:8 against serogroups A, C, W-135 and Y. At one month post vaccination, the percentages of subjects with hSBA≥1:8 were 98%-100% and 84%-96%, respectively.
Slovenian: Po 7 dneh po poživitvenem odmerku je 98 %-100 % oseb, ki so predhodno prejele cepivo Menveo, in 73 %-84 % oseb, ki so predhodno prejele cepivo ACWY-PS, doseglo hSBA ≥ 1 : 8 proti seroskupinam A, C, W-135 in Y. Po enem mesecu po cepljenju je bil odstotek oseb s hSBA ≥ 1 : 8 98 %-100 % oziroma 84 %-96 %.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees (see section 5.1).
Slovenian: Kot pri vsakem drugem cepivu zaščitni imunski odziv morda ne bo dosežen pri vseh cepljenih osebah
English: Concomitant vaccines should always be administered at separate injection sites and preferably contralateral.
Slovenian: Druga, sočasno uporabljena cepiva je treba vedno aplicirati na drugo mesto, po možnosti na nasprotni strani telesa.
English: Even if you have been vaccinated with Menveo you remain at increased risk of disease caused by the Neisseria meningitidis groups A, C, W-135 and Y bacteria.
Slovenian: Tudi če ste bili cepljeni s cepivom Menveo, imate še vedno večje tveganje za bolezen, ki jo povzročajo bakterije Neisseria meningitidis skupin A, C, W-135 in Y. Kot odziv na vbod z iglo se lahko pojavijo omedlevica, omotica ali druge s stresom povezane reakcije.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo powder for injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Menveo raztopina za injiciranje konjugat MenCWY intramuskularna uporaba
English: Y. At 1 month post last vaccination, the percentages of subjects with hSBA ≥1:8 in the 2-dose group and in the single dose group across the two age strata were: 90%-95% vs 76%-80% for serogroup A, 98%-99% vs 76%-87% for serogroup C, 99% vs 93%-96% for serogroup W-135, and 96% vs 65%69% for serogroup Y. GMTs were higher in the 2-dose group than the single dose group at 1 month after vaccination in both age strata; however, this difference was less pronounced in the older age stratum.
Slovenian: Na začetku študije so bili odstotki oseb s hSBA ≥ 1:8 pri obeh starostnih skupinah: 1 %-5 % pri seroskupini A, 13 %-28 % pri seroskupini C, 42 %-64 % pri seroskupini W-135 in 6 %-19 % pri seroskupini Y. En mesec po zadnjem cepljenju so bili odstotki oseb s hSBA ≥ 1:8 po seriji z dvema odmerkoma in z enkratnim odmerkom pri obeh starostnih skupinah: 90 %-95 % v primerjavi s 76 %-80 % pri seroskupini A, 98 %-99 % v primerjavi s 76 %-87 % pri seroskupini C, 99 % v primerjavi s 93 %-96 % pri seroskupini W-135 in 96 % v primerjavi s 65 %-69 % pri seroskupini Y. Geometrične povprečne vrednosti so bile v obeh starostnih skupinah višje v skupini z dvema odmerkoma kot v skupini z enkratnim odmerkom en mesec po cepljenju, vendar pa je bila ta razlika manj izrazita v starejši skupini.
English: Talk to your doctor or nurse before you or your child are given Menveo if you or your child: - have a weakened immune system.
Slovenian: Preden vas ali vašega otroka cepijo s cepivom Menveo, se posvetujte z zdravnikom ali medicinsko sestro, če vi ali vaš otrok:
English: These include the following vaccines: tetanus, reduced diphtheria and acellular pertussis (Tdap), human papillomavirus (HPV), yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies, hepatitis A and B and meningococcal group B (Bexsero).
Slovenian: cepivo proti rumeni mrzlici, cepivo proti tifusni vročici (polisaharid Vi), cepivo proti japonskem encefalitisu, cepivo proti steklini, cepivo proti hepatitisu A, cepivo proti hepatitisu B in cepivo proti meningokokom skupine B (Bexsero).
English: Serogroup hSBA ≥1:8
Slovenian: Seroskupina hSBA ≥1:8
English: NAME OF THE MEDICINAL PRODUCT Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Slovenian: Navodilo za uporabo Menveo prašek in raztopina za raztopino za injiciranje konjugirano cepivo proti meningokokom skupin A, C, W-135 in Y
English: • Meningococcal group Y oligosaccharide
Slovenian: • Oligosaharid meningokoka skupine Y
English: Menveo does not protect against diphtheria.
Slovenian: Cepivo Menveo ne ščiti pred davico.
English: W-135 N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Slovenian: W135 N=96 N=96 N=95 N=95 N=64 N=64 N=60
English: • Meningococcal group A oligosaccharide
Slovenian: • Oligosaharid meningokoka skupine A
English: At one year post vaccination in these same subjects, compared with ACWY-PS, a higher proportion of subjects vaccinated with Menveo had hSBA ≥1:8 for serogroups C, W-135, and Y, with comparable levels for serogroup A. Similar findings were observed in the comparison of hSBA GMTs.
Slovenian: Eno leto po cepljenju je bil delež oseb, cepljenih s cepivom Menveo, s hSBA ≥1:8 višji v primerjavi s cepivom ACWY-PS, za seroskupine C, W-135 in Y, s primerljivimi ravnmi za seroskupino A. Podobni so tudi izsledki primerjave GMT hSBA.
English: Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms
Slovenian: Oligosaharidi meningokoka skupine W-135, 5 mikrogramov, vezani na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 3,3-8,3 mikrograma
English: C N=96 N=96 N=94 N=94 N=64 N=64 N=60 N=60
Slovenian: C N=96 N=96 N=94 N=94 N=64 N=64 N=60
English: Reconstitution of the vaccine
Slovenian: Shranjevanje cepiva Menveo
English: Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell
Slovenian: Zelo pogosti: glavobol, slabost, bolečina na mestu injiciranja, rdečina na mestu injiciranja (≤ 50 mm), otrdelost na mestu injiciranja (≤ 50 mm), bolečina mišic, splošno slabo počutje
English: Y N=96 N=96 N=94 N=94 N=64 N=64 N=59 N=59
Slovenian: Y N=96 N=96 N=94 N=94 N=64 N=64 N=59
English: Skin and subcutaneous tissue disorders:
Slovenian: Zelo pogosti: navzea Bolezni kože in podkožja:
English: Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm)
Slovenian: Zelo pogosti: razdražljivost, splošno slabo počutje, bolečina na mestu injiciranja, eritem na mestu injiciranja (≤ 50 mm), otrdlina na mestu injiciranja (≤ 50 mm)
English: Skin and subcutaneous tissue disorders: Common: rash
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva: Zelo pogosti: mialgija
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml of the reconstituted vaccine) contains: (Originally contained in the powder)
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Menveo En odmerek (0,5 ml rekonstituiranega cepiva) vsebuje:
English: Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms
Slovenian: Oligosaharidi meningokoka skupine C, 5 mikrogramov, vezani na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 7,1-12,5 mikrograma
English: Meningococcal group A oligosaccharides 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7-33.3 micrograms
Slovenian: Oligosaharidi meningokoka skupine A, 10 mikrogramov, vezane na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 16,7-33,3 mikrograma
English: Persistence of immune response and booster response in adolescents
Slovenian: Obstojnost imunskega odziva in odziv po poživitvenem odmerku pri otrocih, starih od 2 do 10 let
English: Serog roup
Slovenian: Seroskupina
English: Common: injection site erythema (>50 mm), injection site induration (>50 mm), fever ≥38°C, chills Uncommon: injection site pruritus
Slovenian: Pogosti: eritem na mestu injiciranja (> 50 mm), otrdlina na mestu injiciranja (> 50 mm), zvišana telesna temperatura ≥ 38 °C, mrzlica Občasni: pruritus na mestu injiciranja
English: Percentages of subjects with hSBA≥1:8
Slovenian: Odstotek oseb s hSBA ≥ 1 : 8
English: For children 2 to 10 years of age, no data are available for evaluating safety and immunogenicity of other childhood vaccines when administered concomitantly with Menveo.
Slovenian: Podatkov o varnosti in imunogenosti drugih otroških cepiv, ki se dajejo sočasno s cepivom Menveo,
English: 12 mont hs
Slovenian: 12 mesec ev
English: Uncommon: dizziness
Slovenian: Občasni: omotica
English: Meningococcal group Y oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6-10.0 micrograms.
Slovenian: Oligosaharidi meningokoka skupine Y, 5 mikrogramov, vezani na beljakovino CRM197 bakterije Corynebacterium diphtheriae, 5,6-10,0 mikrograma
English: CI) A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Slovenian: A N=96 N=96 N=95 N=95 N=64 N=64 N=60
English: P Value Menveo vs ACWYPS
Slovenian: P-vrednost cepiva Men veo v primerjav i z ACWY-PS
English: and Y, with the percentages of subjects with hSBA ≥ 1:8 being 32% and 56% against serogroup C in subjects 2-5 and 6-10 years of age, respectively, 74% and 80% against serogroup W-135, and 48% and 53% against serogroup Y. GMTs were respectively 6.5 and 12 for serogroup C, 19 and 26 for serogroup W-135, and 8.13 and 10 for serogroup Y. For serogroup A, 14% and 22% of subjects 2-5
Slovenian: Ugotovili so prisotnosti protiteles proti seroskupinam C, W-135 in Y, pri čemer je bil delež oseb z vrednostjo hSBA ≥ 1:8 za seroskupino C 32 % v starostni skupini 2-5 let in 56 % v starostni skupini 6-10 let, za seroskupino W-135 74 % v starostni skupini 2-5 let in 80 % v starostni skupini 6-10 let, in za seroskupino Y 48 % v starostni skupini 2-5 let in 53 % v starostni skupini 6-10 let.
English: CI)
Slovenian: IZ)
English: GlaxoSmithKline BV Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
Slovenian: Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
English: The immune response observed in the children 2-10 years of age was very similar to those observed in the V59P8 study shown above: immune response to Menveo at 1 month post vaccination, as measured by percentage of subjects with seroresponse, hSBA≥1:8 and GMTs, was non-inferior to ACWY-PS.
Slovenian: Imunski odziv, ki so ga opazili pri otrocih, starih 2-10 let, je bil podoben kot pri študiji V59P8, kot je prikazano zgoraj: imunski odziv na cepivo
English: Very common:
Slovenian: Zelo pogosti: Pogosti:
English: ACWY-PS for all four serogroups and statistically superior for serogroups A and Y (Table 10).
Slovenian: Razmerje oseb s titri hSBA ≥ 1:8 ni bilo inferiorno kot pri ACWY-PS za vse štiri seroskupine, za skupini A in Y pa je bilo statistično boljše (tabela 10).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENA LYOPHILISED CONJUGATE COMPONENT
Slovenian: VIALA OZNAKA SESTAVINA S TEKOČIM KONJUGATOM MENCWY
English: The reactogenicity profile and rates of adverse events among subjects aged 56-65 years who received Menveo (N=216), were similar to that observed in Menveo recipient subjects aged 11-55.
Slovenian: ki so dobili cepivo Menveo (n = 216) so bile podobne tistim, ki so jih opazili pri osebah, cepljenih s cepivom Menveo, starih med 11-55 let.
English: Menveo Menveo ACWY-P S
Slovenian: ACWYPS Menveo ACWYPS Menveo ACWY-PS
English: and 6-10 years of age, respectively, had hSBA ≥ 1:8 (GMTs 2.95 and 3.73).
Slovenian: Delež oseb z vrednostjo hSBA ≥ 1:8 za seroskupino A je bil 14 % (GMT 2,95) v starostni skupini 2-5 let in 22 % (GMT 3,73) v starostni skupini 6-10 let.
English: All subjects in both age groups had hSBA ≥ 1:8 across all serogroups, with antibody titers several fold higher than seen after the primary vaccination (Table 3).
Slovenian: Pri vseh osebah je bila v obeh starostnih skupinah vrednost hSBA ≥ 1:8 za vse seroskupine,
English: How to use Menveo
Slovenian: Način uporabe
English: Sodium dihydrogen phosphate monohydrate
Slovenian: Raztopina natrijev dihidrogenfosfat monohidrat natrijev hidrogenfosfat dihidrat natrijev klorid voda za injekcije
English: Menveo contains
Slovenian: Cepivo Menveo vsebuje
English: In 5 years post vaccination, the percentage of Menveo recipients with hSBA ≥ 1:8 remained significantly higher compared with ACWY-PS recipients for serogroups C and Y. Higher hSBA GMTs were observed for serogroups W-135 and Y (Table 7).
Slovenian: 5 let po cepljenju je odstotek prejemnikov cepiva Menveo s hSBA ≥ 1:8 za seroskupini C in Y ostal značilno večji v primerjavi s prejemniki cepiva ACWY-PS.
English: Common: rash, injection site redness (> 50 mm), injection site firmness (> 50 mm), joint ache, fever ≥ 38°C, chills
Slovenian: Pogosti: izpuščaj, rdečina na mestu injiciranja (>50 mm), otrdelost na mestu injiciranja (>50 mm), bolečina sklepov, zvišana telesna temperatura ≥ 38 °C, mrzlica
English: Common (may affect up to 1 in 10 people): change in eating habits, nausea, vomiting, diarrhea, rash, muscle ache, joint ache, chills, fever ≥38oC, injection site redness (>50mm) and injection site firmness (>50mm)
Slovenian: slabost, bruhanje, driska, izpuščaj, bolečina mišic, bolečina sklepov, mrzlica, zvišana telesna temperatura ≥ 38 °C, rdečina na mestu injiciranja (>50 mm) in otrdelost na mestu injiciranja (>50 mm)
English: Timepo int
Slovenian: Menve o
English: Menveo ACWYPS Menveo ACWY-P S Menveo ACWYPS Menveo ACWY-PS A N=280 N=281 N=280 N=281 N=253 N=238 N=253 N=238
Slovenian: A n = 280 n = 281 n = 280 n = 281 n = 253 n = 238 n = 253 n = 238
English: P Value Menveo vs
Slovenian: Pred poživitveni m odmerkom
English: hSBA ≥ 1:8 (95% CI)
Slovenian: GMT hSBA (95 % I Z)
English: Powder
Slovenian: KG
English: Intramuscular use
Slovenian: Poživitveni odmerek
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENCWY LIQUID CONJUGATE COMPONENT
Slovenian: OVOJNINAH VIALA OZNAKA SESTAVINA LIOFILIZIRANEGA KONJUGATA MENA
English: Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC
Slovenian: Pogosti: eritem na mestu injiciranja (> 50 mm), otrdlina na mestu injiciranja (> 50 mm), mrzlica,
English: In the non-inferiority study, V59P6, immunogenicity was assessed among adolescents aged 11-17 years who had been randomised to receive either Menveo or ACWY-PS. Menveo was shown to be non-inferior to ACWY-PS vaccine for all four serogroups (A, C, W-135 and Y) based on seroresponse, proportions achieving hSBA ≥1:8, and GMTs.
Slovenian: Pokazalo se je, da cepivo Menveo ni inferiorno od cepiva ACWY-PS za vse štiri seroskupine (A, C, W-135 in Y) na podlagi serološkega odziva, razmerij v doseganju hSBA ≥1:8 in za GMT.
English: Metabolism and nutrition disorders:
Slovenian: Ti neželeni učinki so bili: Presnovne in prehranske motnje:
English: 5 year persistence 1 month after booster
Slovenian: 1 mesec po poživitvenem odmerku
English: GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
Slovenian: Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
English: Sero grou p
Slovenian: Seros kupin a
English: GlaxoSmithKline S.p.A. Tel: +39 (0)45 9218 111
Slovenian: Tel: +39 (0)45 9218 111
English: Very common: injection site pain, injection site erythema (≤50 mm), injection site induration
Slovenian: Zelo pogosti: bolečina na mestu injiciranja, eritem na mestu injiciranja (≤50 mm), otrdlina na mestu injiciranja (≤ 50 mm), splošno slabo počutje
English: No effects on fertility were observed in female rabbits receiving Menveo pre-mating and during pregnancy.
Slovenian: Pri samicah kuncev, cepljenih s cepivom Menveo pred paritvijo in med brejostjo, niso opazili vpliva na sposobnost razmnoževanja.
English: • The Committee considered Protelos and Osseor (strontium ranelate) in the procedure under Article 20 of Regulation (EC) No 726/2004, initiated by the European Commission.
Slovenian: Pregled zdravila Protelos/Osseor se je začel maja 2013 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
English: Background information
Slovenian: Informacije za bolnike