natgillin/translations-raw huggingface dataset:
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.
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.
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
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
In the powder: potassium dihydrogen phosphate and sucrose.
U prašku: kalijev dihidrogenfosfat i saharoza.
Bellaria-Rosia 53018 Sovicille (SI) Italy
GSK Vaccines S.r.l. Bellaria-Rosia 53018 Sovicille (SI) Italija
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).
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).
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)
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)
Serogroup hSBA ≥1:8
Serogrupa hSBA ≥1:8
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)
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)
One dose consists of 1 vial of MenA Lyophilised Conjugate Component to be reconstituted with 1 vial of MenCWY Liquid Conjugate Component.
Jedna doza sadrži 1 bočicu liofiliziranog MenA konjugata za rekonstituciju s 1 bočicom tekućeg
Common: arthralgia
Često: mialgija, artralgija
Menveo must be prepared for administration by reconstituting the powder with the solution.
Rekonstitucija cjepiva Menveo se mora pripremiti za primjenu rekonstitucijom praška s otopinom.
This vaccine can only protect against meningococcal group A, C, W-135, and Y bacteria.
Ovo cjepivo pruža zaštitu samo od bakterija meningokokne grupe A, C, W-135 i Y.
There was antibody persistence observed against serogroups C, W-135
Primijećena je postojanost protutijela protiv serogrupa C, W-135 i
Table 10: Immunogenicity of one dose of Menveo or ACWY-PS in adults aged 56-65 years, measured at one month post vaccination.
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.
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
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
Concomitant vaccines should always be administered at separate injection sites and preferably contralateral.
Kada se cjepiva primjenjuju istodobno, potrebno ih je primijeniti na zasebnim mjestima injiciranja i po mogućnosti na suprotnoj strani tijela.
Table 5: Immunogenicity of one dose of Menveo or ACWY-PS in adolescents, measured at one month post vaccination
Tablica 5: Imunogenost jedne doze cjepiva Menveo ili ACWY-PS u adolescenata, mjereno mjesec dana nakon cijepljenja
Not known: hypersensitivity including anaphylaxis
Nepoznato: preosjetljivost uključujući anafilaksu Poremećaji živčanog sustava:
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).
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).
6-10 years hSBA ≥1:8
6-10 godina hSBA ≥1:8
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).
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%
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)
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)
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.
u „per-protocol“ populaciji (ispitanici koji su dovršili ispitivanje prema protokolu) 1170 djece je cijepljeno cjepivom Menveo, a 1161 primilo je usporedno cjepivo.
General disorders and administration site conditions Not known: injection site cellulitis, injection site swelling, including extensive swelling of the injected limb
Nepoznato: celulitis na mjestu injiciranja, oticanje na mjestu injiciranja uključujući prekomjerno oticanje injiciranog ekstremiteta
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo powder for injection
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Menveo prašak za injekciju MenA konjugat
Potassium dihydrogen phosphate
Prašak saharoza kalijev dihidrogenfosfat
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
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
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MENA LYOPHILISED CONJUGATE COMPONENT
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI KOJA SADRŽI LIOFILIZIRANI MENA KONJUGAT
A booster dose of Menveo was administered 3 years after primary vaccination with Menveo or ACWY-D.
Docjepljivanje cjepivom Menveo primijenjeno je 5 godine nakon prvog cijepljenja cjepivom Menveo ili cjepivom ACWY-PS.
Serogrou p
Serogrup a
Uncommon: dizziness
Nepoznato: vrtoglavica
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.
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.
Very common: myalgia
Vrlo često: mialgija Često: artralgija
6.6 Special precautions for disposal and other handling Menveo must be prepared for administration by reconstituting powder (in vial) with solution (in vial).
Menveo se mora pripremiti za primjenu rekonstituiranjem praška (u bočici) s otopinom (u bočici).
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
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.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Menveo solution for injection
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Menveo otopina za injekciju MenCWY konjugat
It is possible that the effectiveness of Menveo could be reduced in such individuals.
Postoji mogućnost da je učinkovitost cjepiva
In children (from 2 to 10 years of age), the side effects that were reported during clinical trials are listed below.
Nuspojave prijavljene tijekom kliničkih ispitivanja u djece (u dobi od 2 do 10 godina) navedene su u nastavku.
- 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.
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)
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
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.
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.
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.
How to store Menveo
Moguće nuspojave Kako čuvati Menveo
While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo has not been specifically evaluated in immunocompromised people.
Obzirom da infekcija virusom humane imunodeficijencije (HIV) nije kontraindikacija,
What you need to know before you or your child are given Menveo
Vi ili Vaše dijete primite Menveo Kako primjenjivati Menveo
Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 2-5 years and 6-10 years
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
In two supportive studies V59P8 and V59P10 immunogenicity of Menveo was compared to ACWY-PS.
V59P8 i V59P10, uspoređena je imunogenost cjepiva Menveo s ACWY-PS.
Conjugated to Corynebacterium diphtheriae CRM197 protein
Konjugiran na protein CRM197 Corynebacterium diphtheriae
Excipients: Potassium dihydrogen phosphate, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, water for injection.
POPIS POMOĆNIH TVARI Pomoćne tvari: kalijev dihidrogenfosfat, saharoza, natrijev klorid, natrijev dihidrogenfosfat hidrat,
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.
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.
Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years
Tablica 4: Odgovori serumskih baktericidnih protutijela mjesec dana nakon cijepljenja cjepivom Menveo u ispitanika u dobi od 11 do 18 godina
Table 9: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years
Tablica 9: Odgovori serumskih baktericidnih protutijela mjesec dana nakon cijepljenja cjepivom Menveo u ispitanika u dobi od 19 do 55 godina
If a vaccine recipient is undergoing immunosuppressant treatment, the immunological response may be diminished.
Imunološki odgovor može biti slabiji ako je bolesnik podvrgnut imunosupresivnoj terapiji.
Metabolism and nutrition disorders:
Poremećaji metabolizma i prehrane: Često: poremećaji prehrane Poremećaji živčanog sustava:
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.
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.
Separate injection sites must be used if more than one vaccine is being administered at the same time.
Ako se u isto vrijeme primjenjuje više od jednog cjepiva, potrebno ih je injicirati na različita mjesta.
It should be checked if the adverse reactions may be intensified by any co-administration.
Potrebno je provjeriti mogu li se nuspojave pojačati kod istodobne primjene cjepiva Menveo s bilo kojim cjepivom.
Intramuscular use
Za intramuskularnu primjenu
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).
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%
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).
Ispitivanja s cjepivom Menveo pokazala su smanjenje titra baktericidnih protutijela u serumu protiv serogrupe A u testu s humanim komplementom (engl.
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.
Vam preporučiti da primite Menveo ako ste u visokom riziku od infekcije bakterijama meningokokne grupe A, C, W-135 i Y.
België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 10 85 52 00
Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Menveo prašak i otopina za otopinu za injekciju Konjugirano cjepivo protiv meningokoka grupe A, C, W-135 i Y
Immune system disorders
Poremećaji imunološkog sustava:
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.
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,
- have haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).
Menveo smanjena u takvih osoba. - imate hemofiliju ili neki drugi problem koji može spriječiti ispravno zgrušavanje krvi,
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.
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.
Uncommon: injection site pruritus
Manje često: pruritus na mjestu injiciranja
In adolescents (from 11 years of age) and adults, the most common side effects that were reported during clinical trials are listed below.
Najčešće nuspojave prijavljene tijekom kliničkih ispitivanja u adolescenata (u dobi od 11 i više godina) i odraslih navedene su u nastavku.
• Meningococcal group A oligosaccharide
• Oligosaharid meningokokne grupe
Meningococcal group C oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1-12.5 micrograms
5 mikrograma oligosaharida meningokokne grupe C konjugirano na 7,1-12,5 mikrograma proteina CRM197 Corynebacterium diphtheriae
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.
≥ 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.
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).
- 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
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - POWDER IN VIAL AND SOLUTION IN VIAL
KARTONSKA KUTIJA - PRAŠAK U BOČICI I OTOPINA U BOČICI
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).
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.
Tel: + 420 2 22 00 11 11 cz.info@gsk.com
Česká republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 11 cz.info@gsk.com
Meningococcal group W-135 oligosaccharides 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3-8.3 micrograms
5 mikrograma oligosaharida meningokokne grupe W-135 konjugirano na 3,3-8,3 mikrograma proteina CRM197 Corynebacterium diphtheriae
5 year persistence 1 month after booster
1 mjesec nakon docjepljivanja
Menveo ACWY-P S
ACWY-P S
Common: nausea, vomiting, diarrhea
Često: mučnina, povraćanje, proljev Poremećaji kože i potkožnog tkiva:
Very common: headache, nausea, injection site pain, injection site redness (≤ 50 mm), injection site firmness (≤ 50 mm), muscle ache, generally feeling unwell
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
ACWY-PS for all four serogroups and statistically superior for serogroups A and Y (Table 10).
ACWY-PS za sve serogrupe, a bio je statistički superioran za serogrupe
Menveo is a powder and a solution for injection.
Kako Menveo izgleda i sadržaj pakiranja Menveo je prašak i otopina za injekciju.
NAME OF THE MEDICINAL PRODUCT Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
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
Timepoint
Vremensk a točka
12 months post-vaccination hSBA ≥1:8
12 mjeseci nakon cijepljenja hSBA ≥1:8
Common: rash
Često: osip
and 6-10 years of age, respectively, had hSBA ≥ 1:8 (GMTs 2.95 and 3.73).
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).
3 years
7 dana
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).
A 75% (780/1039); serogrupa C 80% (735/923); serogrupa W-135 94% (570/609); serogrupa Y 81% (510/630).
GlaxoSmithKline d.o.o.
GlaxoSmithKline A.E.B.E
Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC
Često: eritem na mjestu injiciranja (>50 mm), otvrdnuće na mjestu injiciranja (>50 mm), vrućica ≥38°C, zimica
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).
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
P Value Menveo vs ACWYPS
P vrijedn ost Menveo naspram ACWYPS
In non-clinical studies, Menveo had no direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
embrionalni/fetalni razvoj, porod ili postnatalni razvoj.
The comparative immunogenicity of Menveo vs. ACWY-PS was evaluated in subjects aged 56-65 years, in study V59P17.
U ispitivanju V59P17 ispitana je komparativna imunogenost cjepiva Menveo u usporedbi s ACWY-PS u ispitanika u dobi od 56 do 65 godina.
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
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