FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3: Persistence of immune responses 5 years after primary vaccination with Menveo, and immune responses 1 month after a booster dose among subjects aged 2 - 5 years and 6 -10 years at the time of primary vaccination
Croatian: Tablica 3: Postojanost imunoloških odgovora 5 godina nakon prvog cijepljenja cjepivom Menveo i imunološki odgovori 1 mjesec nakon docjepljivanja ispitanika u dobi od 2 do 5 godina i 6 do 10 godina u vrijeme prvog cijepljenja
English: Concomitant vaccines should always be administered at separate injection sites and preferably contralateral.
Croatian: Kada se cjepiva primjenjuju istodobno, potrebno ih je primijeniti na zasebnim mjestima injiciranja i po mogućnosti na suprotnoj strani tijela.
English: Table 5: Immunogenicity of one dose of Menveo or ACWY-PS in adolescents, measured at one month post vaccination
Croatian: Tablica 5: Imunogenost jedne doze cjepiva Menveo ili ACWY-PS u adolescenata, mjereno mjesec dana nakon cijepljenja
English: Not known: hypersensitivity including anaphylaxis
Croatian: Nepoznato: preosjetljivost uključujući anafilaksu Poremećaji živčanog sustava:
English: In another randomised, observer-blind study (V59P8) US children were immunized with a single dose of either Menveo (N=284) or ACWY-PS (N=285).
Croatian: U drugom randomiziranom, za ocjenitelja slijepom ispitivanju (V59P8) djeca iz SAD-a su imunizirana pojedinačnom dozom cjepiva Menveo (N=284) ili cjepiva ACWY-PS (N=285).
English: 6-10 years hSBA ≥1:8
Croatian: 6-10 godina hSBA ≥1:8
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).
Croatian: U podskupini ispitanika u dobi između 19 i 55 godina koji su bili seronegativni na početku, udio ispitanika koji su postigli hSBA ≥ 1:8 nakon primanja doze cjepiva Menveo navedeni su u nastavku: serogrupa A 67% (582/875); serogrupa C 71% (401/563); serogrupa W-135 82% (131/160); serogrupa Y 66%
English: Very common (may affect more than 1 in 10 people): sleepiness, headache, irritability, generally feeling unwell, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm)
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba): pospanost, glavobolja, razdražljivost, opće loše stanje, bol na mjestu injiciranja, crvenilo na mjestu injiciranja (≤ 50 mm), otvrdnuće na mjestu injiciranja (≤ 50 mm)
English: In the pivotal study V59P20 immunogenicity of Menveo was compared to ACWY-D; 1170 children were vaccinated with Menveo and 1161 received the comparator vaccine in the per protocol populations.
Croatian: u „per-protocol“ populaciji (ispitanici koji su dovršili ispitivanje prema protokolu) 1170 djece je cijepljeno cjepivom Menveo, a 1161 primilo je usporedno cjepivo.
English: General disorders and administration site conditions Not known: injection site cellulitis, injection site swelling, including extensive swelling of the injected limb
Croatian: Nepoznato: celulitis na mjestu injiciranja, oticanje na mjestu injiciranja uključujući prekomjerno oticanje injiciranog ekstremiteta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo powder for injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Menveo prašak za injekciju MenA konjugat
English: Potassium dihydrogen phosphate
Croatian: Prašak saharoza kalijev dihidrogenfosfat
English: Table 2: Immunogenicity of one dose of Menveo or ACWY-PS in subjects 2 through 10 years of age, measured at one month and twelve months post-vaccination
Croatian: Tablica 2: Imunogenost jedne doze cjepiva Menveo ili ACWY-PS u ispitanika u dobi od 2 do 10 godina, mjerena jedan mjesec te dvanaest mjeseci nakon cijepljenja
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENA LYOPHILISED CONJUGATE COMPONENT
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI KOJA SADRŽI LIOFILIZIRANI MENA KONJUGAT
English: A booster dose of Menveo was administered 3 years after primary vaccination with Menveo or ACWY-D.
Croatian: Docjepljivanje cjepivom Menveo primijenjeno je 5 godine nakon prvog cijepljenja cjepivom Menveo ili cjepivom ACWY-PS.
English: Serogrou p
Croatian: Serogrup a
English: Uncommon: dizziness
Croatian: Nepoznato: vrtoglavica
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.
Croatian: U populaciji staroj od 11 do 18 godina u pivotalnom ispitivanju V59P13, imunogenost pojedinačne doze cjepiva Menveo mjesec dana nakon cijepljenja uspoređena je s ACWY-D.
English: Very common: myalgia
Croatian: Vrlo često: mialgija Često: artralgija
English: 6.6 Special precautions for disposal and other handling Menveo must be prepared for administration by reconstituting powder (in vial) with solution (in vial).
Croatian: Menveo se mora pripremiti za primjenu rekonstituiranjem praška (u bočici) s otopinom (u bočici).
English: At baseline, the percentage of subjects with hSBA ≥1:8 across the two age strata was 1%-5% for serogroup A, 13%-28% for serogroup C, 42%-64% for serogroup W-135, and 6%-19% for serogroup
Croatian: Na početku ispitivanja, postotak ispitanika sa hSBA ≥1:8 u obje dobne skupine bio je 1%-5% za serogrupu A, 13%-28% za serogrupu C, 42%-64% za serogrupu W-135 i 6%-19% za serogrupu Y.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo solution for injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Menveo otopina za injekciju MenCWY konjugat
English: It is possible that the effectiveness of Menveo could be reduced in such individuals.
Croatian: Postoji mogućnost da je učinkovitost cjepiva
English: In children (from 2 to 10 years of age), the side effects that were reported during clinical trials are listed below.
Croatian: Nuspojave prijavljene tijekom kliničkih ispitivanja u djece (u dobi od 2 do 10 godina) navedene su u nastavku.
English: - ever had an allergic reaction to the active substances or any of the other ingredients of this vaccine (listed in section 6) - ever had an allergic reaction to diphtheria toxoid (a substance used in a number of other vaccines) - an illness with high fever.
Croatian: Vi ili Vaše dijete primite Menveo Nemojte primjenjivati Menveo ako ste Vi ili Vaše dijete: - imali alergijsku reakciju na djelatne tvari ili neki drugi sastojak ovog cjepiva (naveden u dijelu 6.) - imali alergijsku reakciju na toksoid difterije (tvar koja se koristi u drugim cjepivima)
English: In the pivotal, randomised, observer-blind study V59P20, in which participants were stratified by age (2 through 5 years and 6 through 10 years), the immunogenicity of a single dose of Menveo one month post vaccination was compared with the single dose of ACWY-D. Immunogenicity results one month after Menveo vaccination among subjects aged 2-5 years and 6-10 years are summarized below in Table 1
Croatian: U pivotalnom, randomiziranom, za ocjenitelja slijepom ispitivanju V59P20, u kojem su ispitanici bili stratificirani prema dobi (od 2 do 5 godina i od 6 do 10 godina), imunogenost pojedinačne doze cjepiva Menveo mjesec dana nakon cijepljenja uspoređena je s pojedinačnom dozom cjepiva ACWY-D.
English: In the children 2-10 years of age, as well as in each age strata (2-5 and 6-10 years), immune response as measured by percentage of subjects with seroresponse, hSBA≥1:8 and GMTs were not only non-inferior to comparator vaccine ACWY-PS, but all were statistically higher than the comparator for all serogroups and all immune measurements at 1 month post vaccination.
Croatian: imunološki odgovori, određeni prema postotku ispitanika sa serološkim odgovorom hSBA≥1:8 i GMTs, nisu bilo samo neinferiorni u odnosu na usporedno cjepivo ACWY-PS, već su bili statistički viši od usporednog cjepiva za sve serogrupe i u svim imunološkim mjerenjima mjesec dana nakon cijepljenja.
English: How to store Menveo
Croatian: Moguće nuspojave Kako čuvati Menveo
English: While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo has not been specifically evaluated in immunocompromised people.
Croatian: Obzirom da infekcija virusom humane imunodeficijencije (HIV) nije kontraindikacija,
English: What you need to know before you or your child are given Menveo
Croatian: Vi ili Vaše dijete primite Menveo Kako primjenjivati Menveo
English: Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 2-5 years and 6-10 years
Croatian: Tablica 1: Odgovori serumskih baktericidnih protutijela mjesec dana nakon cijepljenja cjepivom Menveo u ispitanika u dobi od 2 do 5 godina i 6 do 10 godina
English: In two supportive studies V59P8 and V59P10 immunogenicity of Menveo was compared to ACWY-PS.
Croatian: V59P8 i V59P10, uspoređena je imunogenost cjepiva Menveo s ACWY-PS.
English: Conjugated to Corynebacterium diphtheriae CRM197 protein
Croatian: Konjugiran na protein CRM197 Corynebacterium diphtheriae
English: Excipients: Potassium dihydrogen phosphate, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, water for injection.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: kalijev dihidrogenfosfat, saharoza, natrijev klorid, natrijev dihidrogenfosfat hidrat,
English: At 1 year post vaccination, Menveo continued to be statistically higher than ACWY-PS for serogroups A, W-135 and Y, as measured by percentage of subjects with hSBA≥1:8 and GMTs.
Croatian: Godinu dana nakon cijepljenja Menveo je imao i dalje statistički viši imunološki odgovor od cjepiva ACWY-PS za serogrupe A, W-135 i Y prema mjerenjima postotka ispitanika s hSBA≥1:8 i GMTs.
English: Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years
Croatian: Tablica 4: Odgovori serumskih baktericidnih protutijela mjesec dana nakon cijepljenja cjepivom Menveo u ispitanika u dobi od 11 do 18 godina
English: Table 9: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years
Croatian: Tablica 9: Odgovori serumskih baktericidnih protutijela mjesec dana nakon cijepljenja cjepivom Menveo u ispitanika u dobi od 19 do 55 godina
English: If a vaccine recipient is undergoing immunosuppressant treatment, the immunological response may be diminished.
Croatian: Imunološki odgovor može biti slabiji ako je bolesnik podvrgnut imunosupresivnoj terapiji.
English: Metabolism and nutrition disorders:
Croatian: Poremećaji metabolizma i prehrane: Često: poremećaji prehrane Poremećaji živčanog sustava:
English: At 5 years after primary vaccination, there were significantly higher percentages of subjects with hSBA ≥ 1:8 in the Menveo group than in the vaccine-naive control subjects against all the four serogroups.
Croatian: Pet godina nakon prvog cijepljenja, skupina koja je primala Menveo imala je znatno veće postotke ispitanika s hSBA ≥ 1:8 od kontrolnih ispitanika koji nisu primili cjepivo protiv sve četiri serogrupe.
English: Separate injection sites must be used if more than one vaccine is being administered at the same time.
Croatian: Ako se u isto vrijeme primjenjuje više od jednog cjepiva, potrebno ih je injicirati na različita mjesta.
English: It should be checked if the adverse reactions may be intensified by any co-administration.
Croatian: Potrebno je provjeriti mogu li se nuspojave pojačati kod istodobne primjene cjepiva Menveo s bilo kojim cjepivom.
English: Intramuscular use
Croatian: Za intramuskularnu primjenu
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).
Croatian: Nakon 1 godine od zadnjeg cijepljenja, postotci ispitanika sa hSBA ≥1:8 nakon serije s 2 doze i nakon jednostruke doze bili su niži nego 1 mjesec nakon cijepljenja (30% nakon serije s 2 doze, 11%-20% nakon jednostruke doze za serogrupu A; 61%-81% i 41%-55% za serogrupu C; 92%-94% i 90%-91%
English: Studies with Menveo have shown a waning of serum bactericidal antibody titers against serogroup A when using human complement in the assay (hSBA) (see section 5.1).
Croatian: Ispitivanja s cjepivom Menveo pokazala su smanjenje titra baktericidnih protutijela u serumu protiv serogrupe A u testu s humanim komplementom (engl.
English: Your doctor or nurse may still recommend that you receive Menveo if you are at high risk of infection with meningococcal group A, C, W-135 and Y bacteria.
Croatian: Vam preporučiti da primite Menveo ako ste u visokom riziku od infekcije bakterijama meningokokne grupe A, C, W-135 i Y.
English: België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
Croatian: België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 10 85 52 00
English: Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Croatian: Menveo prašak i otopina za otopinu za injekciju Konjugirano cjepivo protiv meningokoka grupe A, C, W-135 i Y
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava:
English: Menveo is a vaccine that is used for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to a bacterium named Neisseria meningitidis serogroups A, C, W-135 and Y, to prevent invasive disease.
Croatian: Menveo je cjepivo koje se koristi za aktivnu imunizaciju djece (u dobi od 2 i više godine), adolescenata i odraslih s rizikom izlaganja bakteriji pod nazivom Neisseria meningitidis serogrupa A,
English: - have haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).
Croatian: Menveo smanjena u takvih osoba. - imate hemofiliju ili neki drugi problem koji može spriječiti ispravno zgrušavanje krvi,
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.
Croatian: Nakon 1 mjeseca od zadnjeg cijepljenja, postotci ispitanika sa hSBA ≥1:8 u skupini s 2 doze u odnosu na skupinu s jednostrukom dozom u dvjema dobnim skupinama bili su: 90%-95% naspram 76%-80% za serogrupu A, 98%-99% naspram 76%-87% za serogrupu C, 99% naspram 93%-96% za serogrupu W-135 i 96% naspram 65%-69% za serogrupu Y.
English: Uncommon: injection site pruritus
Croatian: Manje često: pruritus na mjestu injiciranja
English: In adolescents (from 11 years of age) and adults, the most common side effects that were reported during clinical trials are listed below.
Croatian: Najčešće nuspojave prijavljene tijekom kliničkih ispitivanja u adolescenata (u dobi od 11 i više godina) i odraslih navedene su u nastavku.
English: • Meningococcal group A oligosaccharide
Croatian: • Oligosaharid meningokokne grupe
English: Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms
Croatian: 5 mikrograma oligosaharida meningokokne grupe C konjugirano na 7,1-12,5 mikrograma proteina CRM197 Corynebacterium diphtheriae
English: In study V59P6E1, at one year post vaccination, the percentage of Menveo recipients with hSBA ≥ 1:8 remained significantly higher compared with ACWY-PS recipients for serogroups C, W-135 and Y, and similar between the two study groups for serogroup A. hSBA GMTs for serogroups W-135 and Y were higher among Menveo recipients.
Croatian: ≥ 1:8 ostao je znatno veći u usporedbi s primateljima cjepiva ACWY-PS za serogrupe C, W-135 i Y, i sličan između dvije ispitivane skupine za serogrupu A. hSBA GMTs za serogrupe W-135 i Y viši su kod primatelja cjepiva Menveo.
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).
Croatian: - 1 bočica koja sadrži liofilizirani MenA konjugat u obliku praška bijele do bjelkaste boje - 1 bočica koja sadrži liofilizirani MenCWY konjugat u obliku bistre otopine
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - POWDER IN VIAL AND SOLUTION IN VIAL
Croatian: KARTONSKA KUTIJA - PRAŠAK U BOČICI I OTOPINA U BOČICI
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).
Croatian: Pet godina nakon cijepljenja, postotak primatelja cjepiva Menveo s hSBA ≥ 1:8 ostao je znatno veći u usporedbi s primateljima cjepiva ACWY-PS za serogrupe C i Y.
English: Tel: + 420 2 22 00 11 11 cz.info@gsk.com
Croatian: Česká republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 11 cz.info@gsk.com
English: Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms
Croatian: 5 mikrograma oligosaharida meningokokne grupe W-135 konjugirano na 3,3-8,3 mikrograma proteina CRM197 Corynebacterium diphtheriae
English: 5 year persistence 1 month after booster
Croatian: 1 mjesec nakon docjepljivanja
English: Menveo ACWY-P S
Croatian: ACWY-P S
English: Common: nausea, vomiting, diarrhea
Croatian: Često: mučnina, povraćanje, proljev Poremećaji kože i potkožnog tkiva:
English: Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell
Croatian: Vrlo često: glavobolja, mučnina, bol na mjestu injiciranja, crvenilo na mjestu injiciranja (≤ 50 mm), otvrdnuće na mjestu injiciranja (≤ 50 mm), bol u mišićima, opće loše stanje
English: ACWY-PS for all four serogroups and statistically superior for serogroups A and Y (Table 10).
Croatian: ACWY-PS za sve serogrupe, a bio je statistički superioran za serogrupe
English: Menveo is a powder and a solution for injection.
Croatian: Kako Menveo izgleda i sadržaj pakiranja Menveo je prašak i otopina za injekciju.
English: NAME OF THE MEDICINAL PRODUCT Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Croatian: Uputa o lijeku: Informacije za korisnika Menveo prašak i otopina za otopinu za injekciju Konjugirano cjepivo protiv meningokoka grupe A, C, W-135 i Y
English: Timepoint
Croatian: Vremensk a točka
English: 12 months post-vaccination hSBA ≥1:8
Croatian: 12 mjeseci nakon cijepljenja hSBA ≥1:8
English: Common: rash
Croatian: Često: osip
English: and 6-10 years of age, respectively, had hSBA ≥ 1:8 (GMTs 2.95 and 3.73).
Croatian: Za serogrupu A, 14% ispitanika u dobi od 2 do 5 godina i 22% ispitanika u dobi od 6 do 10 godina imalo je hSBA ≥1:8 (GMTs 2,95 i 3,73).
English: 3 years
Croatian: 7 dana
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).
Croatian: A 75% (780/1039); serogrupa C 80% (735/923); serogrupa W-135 94% (570/609); serogrupa Y 81% (510/630).
English: GlaxoSmithKline d.o.o.
Croatian: GlaxoSmithKline A.E.B.E
English: Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC
Croatian: Često: eritem na mjestu injiciranja (>50 mm), otvrdnuće na mjestu injiciranja (>50 mm), vrućica ≥38°C, zimica
English: To ensure optimal antibody levels against all vaccine serogroups, the primary vaccination schedule with Menveo should be completed one month prior to risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y. Bactericidal antibodies (hSBA≥1:8) were observed in at least 64% of subjects at 1 week post vaccination (see section 5.1 for immunogenicity data per individual serogroups).
Croatian: Kako bi se osigurale optimalne razine protutijela protiv svih serogrupa cjepiva, prvo cijepljenje cjepivom Menveo potrebno je dovršiti mjesec dana prije rizika od izlaganja bakteriji
English: GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
Croatian: KG Tel: +49 (0)89 36044 8701 de.impfservice@gsk.com
English: P Value Menveo vs ACWYPS
Croatian: P vrijedn ost Menveo naspram ACWYPS
English: In non-clinical studies, Menveo had no direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Croatian: embrionalni/fetalni razvoj, porod ili postnatalni razvoj.
English: The comparative immunogenicity of Menveo vs. ACWY-PS was evaluated in subjects aged 56-65 years, in study V59P17.
Croatian: U ispitivanju V59P17 ispitana je komparativna imunogenost cjepiva Menveo u usporedbi s ACWY-PS u ispitanika u dobi od 56 do 65 godina.
English: CI) A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
Croatian: A N=96 N=96 N=95 N=95 N=64 N=64 N=60 N=60
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
Croatian: Y uz postotak ispitanika s hSBA ≥1:8 protiv serogrupe C od 32% za ispitanike u dobi od 2 do 5 godina i 56% za ispitanike u dobi od 6 do 10 godina, protiv serogrupe W-135 od 74% za ispitanike u dobi od 2 do 5 godina i 80% za ispitanike u dobi od 6 do 10 godina i protiv serogrupe
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.
Croatian: Sedam dana nakon docjepljivanja, 98% - 100% ispitanika koji su prethodno cijepljeni cjepivom Menveo i 73% - 84% ispitanika koji su prethodno cijepljeni cjepivom ACWY-PS postigli su hSBA ≥1:8 protiv serogrupa A, C, W-135 i Y.
English: Very common: injection site pain, injection site erythema (≤50 mm), injection site induration
Croatian: Vrlo često: bol na mjestu injiciranja, eritem na mjestu injiciranja (≤50 mm), otvrdnuće na mjestu injiciranja (≤50 mm), malaksalost
English: Very rare:
Croatian: Manje često:
English: 4.7 Effects on ability to drive and use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedena ispitivanja utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
English: Menveo Menveo ACWY-P S
Croatian: Menveo ACWYPS Menveo ACWY -PS Menveo ACWY-PS
English: Common: rash, injection site redness (> 50 mm), injection site firmness (> 50 mm), joint ache, fever ≥ 38°C, chills
Croatian: Često: osip, crvenilo na mjestu injiciranja (> 50 mm), otvrdnuće na mjestu injiciranja (> 50 mm), bol u zglobovima, vrućica ≥ 38°C, zimica
English: 4.4 Special warnings and precautions for use
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom