FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/614/003 - 1 dose pack EU/1/10/614/002 - 5 doses pack
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/614/003 - pakiranje s 1 dozom EU/1/10/614/002 - pakiranje s 5 doza
English: The characterization of the safety profile of Menveo in adolescents and adults is based on data from five randomised controlled clinical trials including 6401 participants (from 11-65 years of age) who received Menveo.
Croatian: Osobe u dobi od 11 do 65 godina Karakterizacija sigurnosnog profila cjepiva Menveo u adolescenata i odraslih temelji se na podacima iz pet randomiziranih, kontroliranih kliničkih ispitivanja, uključujući 6401 ispitanika (u dobi od 11 do 65 godina) koji su primili Menveo.
English: The children also received a booster dose of Menveo, 5 years after a single dose primary vaccination.
Croatian: Djeca su također primila docjepljivanje cjepivom Menveo 5 godina nakon prvog cijepljenja pojedinačnom dozom cjepiva.
English: 3.3 to 8.3 micrograms
Croatian: 3,3 do 8,3 mikrograma
English: The clinical relevance of higher post-vaccination immune responses is not known.
Croatian: Klinički značaj viših imunoloških odgovora nakon cijepljenja nije poznat.
English: V59P6E1 (5 years post vaccination)
Croatian: V59P6E1 (5 godina nakon cijepljenja)
English: 16.7 to 33.3 micrograms
Croatian: 16,7 do 33,3 mikrograma
English: Immunogenicity in individuals 11 years of age and above
Croatian: Imunogenost u osoba u dobi od 11 i više godina
English: MARKETING AUTHORISATION HOLDER GSK Vaccines S.r.l.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GSK Vaccines S.r.l.
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.
Croatian: Dva primarna ispitivanja sigurnosti bila su randomizirana i aktivno kontrolirana, a uključivala su ispitanike u dobi od 11 do 55 godina (N=2663), odnosno od 19 do 55 godina (N=1606).
English: Following reconstitution, the vaccine is a clear, colourless to light yellow solution, free from visible foreign particles.
Croatian: Nakon rekonstitucije cjepivo je bistra, bezbojna do svijetložuta otopina, bez vidljivih stranih čestica.
English: 5.6 to 10.0 micrograms
Croatian: 5,6 do 10,0 mikrograma
English: Concomitant administration of Menveo and other vaccines than those listed above has not been studied.
Croatian: Istodobna primjena cjepiva Menveo s drugim cjepivima, osim onih navedenih iznad, nije ispitana.
English: In adolescents (11 to 18 years of age), Menveo has been evaluated in two co-administration studies with either Tetanus, Reduced Diphtheria and Acellular Pertussis Vaccine, Adsorbed (Tdap) alone or Tdap and Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant (HPV), both of which support the co-administration of the vaccines.
Croatian: U adolescenata (u dobi od 11 do 18 godina) Menveo je procijenjen u dva ispitivanja s istodobnom primjenom drugih cjepiva: ili samo s cjepivom protiv tetanusa, difterije (s reduciranom koncentracijom toksoida) i acelularnog pertusisa, adsorbirano (Tdap) ili s Tdap i četverovalentnim cjepivom protiv humanog papiloma virusa (tipovi 6, 11, 16 i 18), rekombinantno (HPV), od kojih oba podržavaju istodobnu primjenu cjepiva.
English: In the solution: sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate dihydrate and water for injection (See also end of Section 2).
Croatian: U otopini: natrijev klorid, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat dihidrat i voda za injekcije (također pogledajte završetak dijela 2).
English: (Originally contained in the solution) • Meningococcal group C oligosaccharide
Croatian: (Izvorno sadržan u otopini) • Oligosaharid meningokokne grupe C
English: Although a high percentage of subjects achieved hSBA titres above 1:8 following 4-dose series of Menveo, with lower percentages in studies of 2-dose series and of a single dose, Menveo was compared to another meningococcal vaccine in only one pivotal study, where it failed to show a response at least equivalent to a monovalent conjugated serotype C vaccine (after a single dose at the age of 12 months).
Croatian: Iako je visoki postotak ispitanika postigao titar hSBA iznad 1:8 nakon serije od 4 doze cjepiva Menveo, s manjim postocima u ispitivanjima sa serijom od 2 doze i jednom dozom, Menveo je uspoređen s još jednim meningokoknim cjepivom u samo jednom pivotalnom ispitivanju, u kojem se pokazalo da nije mogao pružiti odgovor koji bi bio barem jednak monovalentnom konjugiranom cjepivu sa serotipom C (nakon jedne doze u dobi od 12 mjeseci).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena, Italija
English: Antibody responses to Menveo and the diphtheria, tetanus or HPV vaccine components were not negatively affected by co-administration.
Croatian: Odgovori protutijela na Menveo i sastojke cjepiva protiv difterije, tetanusa ili HPV-a nisu bili negativno promijenjeni istodobnom primjenom cjepiva.
English: It must not be administered intravascularly, subcutaneously or intradermally.
Croatian: Ne smije se primijeniti intravaskularno, supkutano ili intradermalno.
English: Serog roup
Croatian: Serog rupa
English: Menveo may be given as a booster dose in subjects who have previously received primary vaccination with Menveo, other conjugated meningococcal vaccine or meningococcal unconjugated polysaccharide vaccine.
Croatian: Docjepljivanje cjepivom Menveo moguće je u ispitanika koji su prethodno primarno cijepljeni cjepivom Menveo, drugim konjugiranim cjepivom protiv meningokoka ili nekonjugiranim polisaharidnim cjepivom protiv meningokoka.
English: No effects on fertility were observed in female rabbits receiving Menveo pre-mating and during pregnancy.
Croatian: U ženki kunića nisu uočene posljedice na plodnost nakon primanja doze cjepiva Menveo u fazi prije parenja i u vrijeme trudnoće.
English: This means that you (or your child) should receive other vaccines to protect against diphtheria when these are due or when advised by your doctor.
Croatian: trebali primiti druga cjepiva radi zaštite od difterije prema rasporedu ili kada Vam to savjetuje liječnik.
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.
Croatian: Profil reaktogenosti i stope nuspojava u ispitanika u dobi od 56 do 65 godina koji su primali Menveo (N=216) bili su slični onima uočenim u ispitanika u dobi od 11 do 55 godina koji su primali Menveo.
English: Immunogenicity in older adults
Croatian: Imunogenost u starijih odraslih osoba
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or diphtheria toxoid (CRM197), or a life-threatening reaction after previous administration of a vaccine containing similar components (see section 4.4).
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 ili na toksoid difterije (CRM197), ili po život opasna reakcija nakon prethodne primjene cjepiva koje sadrži slične sastojke
English: Before the injection of any vaccine, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions including thorough medical history and current health status.
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Prije injiciranja bilo kojeg cjepiva, osoba odgovorna za primjenu treba poduzeti sve poznate mjere opreza kako bi se spriječila alergijska ili bilo koja druga reakcija, što uključuje temeljitu anamnezu i procjenu trenutnog zdravstvenog stanja.
English: Menveo contains
Croatian: Menveo sadrži
English: As with any vaccine, Menveo may not fully protect 100% of those who get the vaccine.
Croatian: Kao i druga cjepiva, Menveo možda neće u potpunosti zaštititi sve cijepljene osobe.
English: Menveo can be given concomitantly with any of the following vaccines: monovalent and combined hepatitis A and B, yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies and meningococcal group B (Bexsero).
Croatian: Menveo se može davati istodobno sa bilo kojim od sljedećih cjepiva: monovalentno i kombinirano cjepivo protiv hepatitisa A i B, cjepiva protiv žute groznice, trbušnog tifusa (Vi polisaharidi), japanskog encefalitisa, bjesnoće i meningokoka grupe B (Bexsero).
English: (≥1/10,000 to <1/1,000)
Croatian: (≥1/10 000 do <1/1000)
English: Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group A, C, W-135 and Y, even if they develop antibodies following vaccination with Menveo.
Croatian: Osobe s nasljednim nedostacima komplemenata (na primjer, nedostatkom C3 ili C5 komponente) i osobe koje primaju terapije koje inhibiraju aktivaciju terminalnog komplementa (na primjer, ekulizumab) imaju povećani rizik od razvoja invazivne bolesti uzrokovane bakterijom Neisseria meningitidis grupe A, C, W-135 i Y, čak i ako su razvili protutijela nakon cijepljenja cjepivom Menveo.
English: Immunogenicity in adolescents
Croatian: Imunogenost u adolescenata
English: Serogroup
Croatian: serogrupa
English: (≥1/100 to <1/10)
Croatian: (≥1/100 do <1/10)
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).
Croatian: To uključuje sljedeća cjepiva: cjepivo protiv tetanusa, difterije (reducirano) i acelularnog pertusisa (Tdap), cjepivo protiv humanog papiloma virusa (HPV), žute groznice, trbušnog tifusa (Vi polisaharidi), japanskog encefalitisa, bjesnoće, hepatitisa A i B i meningokoka grupe B (Bexsero).
English: In the pivotal immunogenicity trial, V59P13, immune responses to Menveo were assessed among adults aged 19 to 55 years.
Croatian: U pivotalnom ispitivanju imunogenosti, V59P13, ispitani su imunološki odgovori na Menveo u odraslih osoba u dobi između 19 i 55 godina.
English: It cannot protect against other types of meningococcal bacteria other than groups A, C, W-135 and Y, or against other causes of meningitis and sepsis (blood poisoning).
Croatian: Ne pruža zaštitu od ostalih vrsta bakterija, osim bakterija meningokokne grupe A, C, W-135 i Y, kao ni od ostalih uzroka meningitisa i sepse (trovanja krvi).
English: Time point
Croatian: Vreme nska točka
English: The differences between hSBA GMTs in the 2-dose and the single dose groups at 1 year after vaccination were lower than those seen at 1 month post-vaccination.
Croatian: Razlike između hSBA GMT u skupinama s 2 doze i s jednostrukom dozom nakon 1 godine od cijepljenja bile su manje od onih zapaženih 1 mjesec nakon cijepljenja.
English: Menveo should under no circumstances be administered intravascularly.
Croatian: Menveo se ni u kojim okolnostima ne smije primijeniti intravaskularno.
English: V59P13E1 (3 years post vaccination)
Croatian: V59P13E1 (3 godine na kon cijepljenja)
English: Dizziness has been very rarely reported following vaccination.
Croatian: Nakon cijepljenja vrlo je rijetko bila zabilježena omaglica.
English: Ensure that no air bubbles are present in the syringe before injecting the vaccine.
Croatian: Prije injiciranja cjepiva povjerite da u štrcaljki nema mjehurića zraka.
English: In a randomized, observer-blind study (V59_57) conducted in US, immunogenicity of a 2-dose series and a single dose of Menveo was compared in children 2 through 5 and 6 through 10 years of age (N=715).
Croatian: U randomiziranom ispitivanju, slijepom za ocjenitelja (V59_57), provedenom u SAD-u, uspoređena je imunogenost serije s 2 doze i jednostruke doze lijeka Menveo u djece u dobi od 2 do 5 i od 6 do 10 godina (N=715).
English: In another study (V59P6) conducted in 524 adolescents, the immunogenicity of Menveo was compared to that of ACWY-PS.
Croatian: U drugom ispitivanju (V59P6) koje je provedeno u 524 adolescenta, imunogenost cjepiva Menveo uspoređena je s onom od ACWY-PS.
English: The administration of Menveo one month after Tdap resulted in statistically significantly lower serogroup W-135 seroresponses.
Croatian: Tdap rezultirala je statistički značajno nižim serološkim odgovorima na serogrupu W-135.
English: In the pivotal study (V59P13), adolescents or adults received either a dose of Menveo (N = 2649) comparator vaccine ACWY-D (N = 875).
Croatian: U pivotalnom ispitivanju (V59P13), adolescenti ili odrasli su primali ili dozu cjepiva Menveo (N=2649), ili usporedno cjepivo ACWY-D (N= 875).
English: In study V59P13E1, the persistence of immune responses against serogroups A, C, W-135 and Y was assessed at 21 months, 3 years and 5 years post primary vaccination among subjects aged 11-18 years at the time of vaccination.
Croatian: U ispitivanju V59P13E1, postojanost imunoloških odgovora protiv serogrupa A, C, W-135 i Y procijenjena je 21 mjesec, 3 godine i 5 godina nakon prvog cijepljenja u ispitanika koji su u vrijeme cijepljenja imali između 11 i 18 godina.
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.
Croatian: Čak i ako ste cijepljeni cjepivom Menveo, i dalje postoji povećani rizik od bolesti uzrokovane bakterijom Neisseria meningitidis grupe A, C, W-135 i Y.
English: Sera were obtained both before vaccination and 1 month after vaccination.
Croatian: Uzorci seruma uzeti su i prije cijepljenja i mjesec dana nakon cijepljenja.
English: (≥1/1,000 to <1/100)
Croatian: (≥1/1000 do <1/100)
English: One dose (2 vials) per package.
Croatian: Jedna doza (2 bočice) po pakiranju.
English: This medicinal products contains less than 1 mmol potassium (39 mg) per dose, i.e. essentially ‘potassium-free'.
Croatian: Ovo cjepivo sadrži manje od 1 mmol kalija (39 mg) po dozi tj. zanemarive količine kalija.
English: What Menveo is and what it is used for What you need to know before you or your child are given Menveo How to use Menveo
Croatian: Što je Menveo i za što se koristi Što morate znati prije nego
English: • Meningococcal group W-135 oligosaccharide
Croatian: • Oligosaharid meningokokne grupe W-135
English: Persistence of immune response and booster response in children 2 to 10 years of age Antibody persistence at 5 years after primary vaccination was assessed in study V59P20E1, this was an extension of study V59P20.
Croatian: Postojanost imunološkog odgovora i odgovora nakon docjepljivanja u djece u dobi od 2 do 10 godina Postojanost protutijela 5 godina nakon prvog cijepljenja procijenjena je u ispitivanju V59P20E1, koje je produžetak ispitivanja V59P20.
English: Menveo is indicated for active immunization of children (from 2 years of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y, to prevent invasive disease.
Croatian: Menveo je indiciran za aktivnu imunizaciju djece (u dobi od 2 i više godina), adolescenata i odraslih s rizikom izloženosti Neisseria meningitidis grupama A, C, W-135 i Y kako bi se spriječila invazivna bolest.
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog cjepiva, obratite se svom liječniku ili medicinskoj sestri.
English: The onset of immune response after the primary vaccination with Menveo in healthy subjects 18 through 22 years of age was evaluated in study V59P6E1.
Croatian: Nastup imunološkog odgovora nakon prvog cijepljenja cjepivom Menveo u zdravih ispitanika u dobi od 18 do 22 godine procijenjen je u ispitivanju V59P6E1.
English: Individuals with complement deficiencies and individuals with functional or anatomical asplenia may not mount an immune response to meningococcal group A, C, W-135 and Y conjugate vaccines.
Croatian: Osobe s deficitom komplementa i one s funkcionalnom ili anatomskom asplenijom možda neće postići imunološki odgovor na konjugirana cjepiva protiv meningokoka grupe A, C, W-135 i Y.
English: For instructions on preparation and reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o pripremi i rekonstituciji lijeka prije primjene vidjeti dio 6.6. 4.3 Kontraindikacije
English: The contents of the two components (vial and vial) are to be mixed prior to vaccination providing 1 dose of 0.5 ml.
Croatian: Sadržaj te dvije komponente (bočice i bočice) treba pomiješati prije cijepljenja tako da se dobije 1 doza od 0,5 ml.
English: The proportion of subjects with hSBA ≥ 1:8 was non-inferior to
Croatian: Udio ispitanika s hSBA ≥ 1:8 je bio neinferioran prema
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Croatian: Ovo cjepivo sadrži manje od 1 mmol natrija (23 mg) po dozi tj. zanemarive količine natrija.
English: 1 month post-vaccination
Croatian: 1 mjesec nakon cijepljenja
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.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije negoVi ili Vaše dijete primite Menveo ako Vi ili
English: Using a syringe and suitable needle (21G, 40 mm length or 21G, 1 ½ inch length), withdraw the entire contents of the vial of solution and inject into the vial of powder to reconstitute the MenA conjugate component.
Croatian: Koristeći štrcaljku i odgovarajuću iglu (21G, duljine 40 mm) izvucite sav sadržaj bočice s otopinom i ubrizgajte ga u bočicu s praškom kako biste rekonstituirali MenA konjugat.
English: The contents in the two different vials (MenA powder and MenCWY solution) are to be mixed prior to vaccination providing 1 dose of 0.5 ml.
Croatian: Sadržaji iz dvije različite bočice (MenA prašak i MenCWY otopina) moraju se pomiješati u jednu dozu od 0,5 ml prije cijepljenja.
English: Very common: nausea
Croatian: Vrlo često: mučnina
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).
Croatian: Obje grupe pokazale su snažan odgovor na docjepljivanje cjepivom Menveo jedan mjesec nakon cijepljenja (100% ispitanika imalo je hSBA ≥ 1:8 za sve serogrupe) i taj odgovor je većinom ostao postojan tijekom 2 godine nakon docjepljivanja za serogrupe C, W-135 i Y (87%
English: Side effects that have been reported during marketed use include:
Croatian: Manje često: omaglica, svrbež na mjestu injiciranja Nuspojave prijavljene tijekom uporabe na tržištu uključuju:
English: Immunogenicity in adults
Croatian: Imunogenost u odraslih osoba
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno lokalnim propisima.
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).
Croatian: Svi ispitanici u obje starosne skupine imali su hSBA ≥1:8 za sve serogrupe s nekoliko puta većim titrom protutijela od titra primijećenog nakon prvog cijepljenja
English: The clinical relevance of the waning of hSBA serogroup A antibody titers is unknown.
Croatian: Klinički značaj smanjenja titra protutijela protiv serogrupe A u hSBA-u nije poznat.
English: In a randomised, observer-blind study (V59P10) conducted in Argentina, children were immunized with a single dose of either Menveo (N=949) or ACWY-PS (N=551).
Croatian: U randomiziranom, za ocjenitelja slijepom ispitivanju, (V59P10) provedenom u Argentini, djeca su imunizirana pojedinačnom dozom cjepiva Menveo (N=949) ili cjepiva ACWY-PS (N=551).
English: Table 6: Persistence of immune responses approximately 21 months, 3 years and 5 years after vaccination with Menveo (subjects were aged 11-18 years at the time of vaccination)
Croatian: Tablica 6: Postojanost imunoloških odgovora približno 21 mjesec, 3 godine i 5 godina nakon cijepljenja cjepivom Menveo (ispitanici su u vrijeme cijepljenja bili u dobi od 11 do 18 godina)
English: A total of 199 subjects 2-5 years of age were in the Menveo per protocol immunogenicity population and 81 subjects 3-5 years of age were in the ACWY-PS group.
Croatian: U „per-protocol“ populaciji koja je primila Menveo bilo je ukupno 199 ispitanika u dobi od 2 do 5 godina, a u skupini koja je primila ACWY-PS bio je 81 ispitanik u dobi od 3 do 5 godina.
English: Table 8: Response to Booster: bactericidal antibody responses to Menveo booster administered at 3 or 5 years after the primary vaccination with Menveo or ACWY-PS in subjects aged 11-17 years
Croatian: Tablica 8: Odgovor na docjepljivanje: odgovori baktericidnih protutijela na docjepljivanje cjepivom Menveo 3 mjeseca i 5 godina nakon prvog cijepljenja cjepivom Menveo ili cjepivom ACWY-PS u ispitanika u dobi od 11 do 17 godina
English: In the powder: potassium dihydrogen phosphate and sucrose.
Croatian: U prašku: kalijev dihidrogenfosfat i saharoza.
English: Bellaria-Rosia 53018 Sovicille (SI) Italy
Croatian: GSK Vaccines S.r.l. Bellaria-Rosia 53018 Sovicille (SI) Italija
English: The percentages of subjects with hSBA ≥ 1:8 remained constant against serogroups C, W-135, and Y from 21 months to 5 years postvaccination in the Menveo group and decreased slightly over time against serogroup A (Table 6).
Croatian: Postotci ispitanika s hSBA ≥ 1:8 ostali su nepromjenljivi protiv serogrupa C, W-135, i Y od 21 mjesec do 5 godina nakon cijepljenja u skupini koja je primala Menveo i malo se smanjili tijekom vremena protiv serogrupe A (Tablica 6).
English: Table 7: Persistence of immune responses approximately 12 months and 5 years after vaccination with Menveo and ACWY-PS (subjects were aged 11-18 years at the time of vaccination)
Croatian: Tablica 7: Postojanost imunoloških odgovora približno 12 mjeseci i 5 godina nakon cijepljenja cjepivom Menveo i cjepivom ACWY-PS (ispitanici su u vrijeme cijepljenja bili u dobi od 11 do 18 godina)
English: Serogroup hSBA ≥1:8
Croatian: Serogrupa hSBA ≥1:8
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)
Croatian: Često (mogu se javiti u do 1 na 10 osoba): promjene prehrambenih navika, mučnina, povraćanje, proljev, osip, bol u mišićima, bol u zglobovima, zimica, vrućica ≥38oC, crvenilo na mjestu injiciranja (>50 mm) i otvrdnuće na mjestu injiciranja (>50 mm)
English: One dose consists of 1 vial of MenA Lyophilised Conjugate Component to be reconstituted with 1 vial of MenCWY Liquid Conjugate Component.
Croatian: Jedna doza sadrži 1 bočicu liofiliziranog MenA konjugata za rekonstituciju s 1 bočicom tekućeg
English: Common: arthralgia
Croatian: Često: mialgija, artralgija
English: Menveo must be prepared for administration by reconstituting the powder with the solution.
Croatian: Rekonstitucija cjepiva Menveo se mora pripremiti za primjenu rekonstitucijom praška s otopinom.
English: This vaccine can only protect against meningococcal group A, C, W-135, and Y bacteria.
Croatian: Ovo cjepivo pruža zaštitu samo od bakterija meningokokne grupe A, C, W-135 i Y.
English: There was antibody persistence observed against serogroups C, W-135
Croatian: Primijećena je postojanost protutijela protiv serogrupa C, W-135 i
English: Table 10: Immunogenicity of one dose of Menveo or ACWY-PS in adults aged 56-65 years, measured at one month post vaccination.
Croatian: Tablica 10: Imunogenost jedne doze cjepiva Menveo ili ACWY-PS u starijih osoba u dobi od 56 do 65 godina, mjereno mjesec dana poslije cijepljenja.