natgillin/translations-raw huggingface dataset:
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.
Razlike med geometričnimi povprečnimi vrednostmi hSBA pri skupinah z dvema odmerkoma in z enkratnim odmerkom eno leto po cepljenju so bile manjše kot en mesec po cepljenju.
In the pivotal study (V59P13), adolescents or adults received either a dose of Menveo (N = 2649) comparator vaccine ACWY-D (N = 875).
V osrednji študiji (V59P13) so mladostniki ali odrasli prejeli bodisi odmerek cepiva Menveo (n = 2.649) ali primerljivo cepivo ACWY-D (n = 875).
The components of the vaccine should be visually inspected before and after reconstitution.
Pred rekonstitucijo in po njej vizualno preglejte komponente cepiva.
In the solution: sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate dihydrate and water for injection (See also end of Section 2).
V raztopini: natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat in voda za injekcije (glejte tudi poglavje 2)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - POWDER IN VIAL AND SOLUTION IN VIAL
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - PRAŠEK V VIALI IN RAZTOPINA V VIALI
A booster dose of Menveo was administered 3 years after primary vaccination with Menveo or ACWY-D.
Poživitveni odmerek cepiva Menveo so aplicirali 3 leta po osnovnem cepljenju s cepivom Menveo ali ACWY-D.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Možni neželeni učinki Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
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)
Tabela 6: Obstojnost imunskega odziva približno po 21 mesecih, 3 letih in 5 letih po cepljenju s cepivom Menveo (osebe so bile v času cepljenja stare 11-18 let)
• Meningococcal group W-135 oligosaccharide
• Oligosaharid meningokoka skupine W-135
Prior to injection, change the needle with one suitable for the administration.
Pred injiciranjem zamenjajte iglo in namestite iglo, primerno za apliciranje.
Powder and solution for solution for injection (powder and solution for injection).
FARMACEVTSKA OBLIKA prašek in raztopina za raztopino za injiciranje (prašek in raztopina za injiciranje)
Excipients: Potassium dihydrogen phosphate, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, water for injection.
Pomožne snovi: kalijev dihidrogenfosfat, saharoza, natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, voda za injekcije
A small decline was observed in percentages of subjects with hSBA ≥ 1:8 against serogroup A, although percentages were still high (77% to 79%).
Pri seroskupini A je bil odstotek oseb s hSBA ≥ 1:8 nekoliko nižji, a še vedno precej visok (77 % do 79 %).
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.
Cepivo Menveo je cepivo, ki se uporablja za aktivno imunizacijo otrok (starejših od 2 let), mladostnikov in odraslih, pri katerih obstaja tveganje za izpostavitev bakteriji po imenu Neisseria meningitidis seroskupin A, C, W-135 in Y za preprečitev invazivne bolezni.
A significant increase in the hSBA GMTs against all four serogroups was also observed at 7 and 28 days after the booster dose (Table 8).
Po 7 in 28 dneh po poživitvenem odmerku so opazili tudi značilno zvišanje GMT hSBA proti vsem štirim seroskupinam (tabela 8).
Contents of the pack and other information
Shranjevanje cepiva Menveo Vsebina pakiranja in dodatne informacije
Menveo must be prepared for administration by reconstituting the powder with the solution.
Cepivo Menveo je treba pripraviti za uporabo z rekonstitucijo praška z raztopino.
What you need to know before you or your child are given Menveo
Kaj morate vedeti, preden se s cepivom Menveo cepite vi ali vaš otrok
Anxiety‐related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see section 4.8 Undesirable effects).
Pri cepljenju se lahko kot psihogeni odziv na vbod igle pojavijo s tesnobo povezane reakcije, vključno z vazovagalnimi reakcijami (sinkopa), hiperventilacija ali s stresom povezane reakcije (glejte poglavje 4.8).
The clinical relevance of the waning of hSBA serogroup A antibody titers is unknown.
Klinični pomen pojemanja titra protiteles proti seroskupini A v hSBA ni znan.
In another study (V59P6) conducted in 524 adolescents, the immunogenicity of Menveo was compared to that of ACWY-PS.
V drugi študiji (V59P6), izvedeni pri 524 mladostnikih, so imunogenost cepiva Menveo primerjali z imunogenostjo cepiva ACWY-PS.
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).
V randomizirani, opazovalni slepi študiji (V59P10), ki so jo opravili v Argentini, so otroke imunizirali z enim odmerkom cepiva Menveo (n =949) ali ACWY-PS (n = 551).
The following information is intended for healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju: Rekonstitucija cepiva
There are limited data in individuals aged 56-65 and there are no data in subjects aged older than 65 years.
starih med 56 in 65 let, so na voljo le omejeni podatki, za bolnike, starejše od 65 let, pa podatkov ni.
Non-clinical data reveal no special hazard for humans based on conventional repeated-dose and reproductive and developmental toxicity studies.
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih se odmerkih in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
The list provided below presents adverse reactions reported in three pivotal and two supportive clinical trials per system organ class.
Neželeni učinki, o katerih so poročali v treh osrednjih in dveh podpornih kliničnih študijah, so našteti v spodnjem seznamu po organskih sistemih.
The comparative immunogenicity of Menveo vs. ACWY-PS was evaluated in subjects aged 56-65 years, in study V59P17.
Primerljivost za imunogenost med cepivom Menveo in ACWY-PS so ocenili v študiji V59P17 pri osebah, starih 56-65 let.
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).
Odstotek oseb s hSBA ≥ 1 : 8 je ostajal stalen pri odzivu na seroskupine C, W-135 in Y od 21 mesecev do 5 let po cepljenju v skupini, ki je prejela cepivo Menveo, in se je sčasoma nekoliko nižal pri odzivu na seroskupino A (tabela 6).
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
Tabela 8: Odziv na poživitveni odmerek: odzivi baktericidnih protiteles na poživitveni odmerek cepiva Menveo, apliciran po 3 ali 5 letih po osnovnem cepljenju s cepivom Menveo ali ACWY-PS pri osebah, starih 11-17 let
While Human Immunodeficiency Virus (HIV) infection is not a contraindication, Menveo has not been specifically evaluated in immunocompromised people.
ni kontraindikacija, cepiva Menveo niso posebej ocenjevali pri osebah z oslabljenim imunskim sistemom.
Although insufficient clinical data on the use of Menveo during breast-feeding are available, it is unlikely that secreted antibodies in milk would be harmful when ingested by a breastfed infant.
Čeprav ni na voljo zadostnih kliničnih podatkov o uporabi cepiva Menveo med dojenjem, ni verjetno,
Your doctor or nurse will dispose of this medicine.
Zdravilo bo zavrgel zdravnik ali medicinska sestra.
The most common adverse reactions during the clinical trials generally persisted for one to two days and were not severe.
Najpogostejši neželeni učinki, ki so jih opazili v kliničnih študijah, so običajno trajali en ali dva dni in niso bili resni.
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.
S premešanjem vsebin dveh različnih vial (praška MenA in raztopine MenCWY) pred cepljenjem dobimo en odmerek 0,5 ml.
- 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.
(navedeno v poglavju 6) - kadar koli imeli alergijsko reakcijo na toksoid davice (snov, ki se uporablja v številnih drugih cepivih) - bolni in imate zvišano telesno temperaturo.
It must not be administered intravascularly, subcutaneously or intradermally.
Cepiva se ne sme aplicirati intravaskularno, subkutano ali intradermalno.
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).
V drugi randomizirani, opazovalni slepi študiji (V59P8) so otroke v ZDA imunizirali z enim odmerkom cepiva Menveo (n = 284) ali ACWY-PS (n = 285).
Not known: hypersensitivity including anaphylaxis
Neznana pogostnost: preobčutljivost, vključno z anafilakso Bolezni živčevja
Table 10: Immunogenicity of one dose of Menveo or ACWY-PS in adults aged 56-65 years, measured at one month post vaccination.
Tabela 10: Imunogenost enega odmerka cepiva Menveo ali ACWY-PS pri odraslih, starih 56-65 let, merjeno en mesec po cepljenju
At 1 month post-first vaccination, the percentages of subjects with hSBA ≥ 1:8 were consistently higher in the Menveo group for all four serogroups (63% vs 39%, 46% vs 39%, 78% vs 59%, and 65% vs 57% for Menveo as compared to ACWY-PS for serogroups A, C, W-135, and Y, respectively).
1 mesec po prvem cepljenju je bil odstotek oseb s hSBA ≥ 1:8 dosledno višji v skupini s cepivom Menveo za vse štiri seroskupine (63 % v primerjavi z 39 %, 46 % v primerjavi z 39 %, 78 % v primerjavi z 59 % in 65 % v primerjavi s 57 % za cepivo Menveo v primerjavi z ACWY-PS za seroskupine A, C, W-135 in Y).
If an individual is expected to be at particular risk of exposure to Men A and received a dose of Menveo more than approximately one year previously, consideration may be given to administering a booster dose.
Treba je razmisliti o dajanju poživitvenega odmerka, če se pričakuje, da bo oseba močno izpostavljena Men A in je pred več kot enim letom prejela odmerek cepiva Menveo.
Very common: sleepiness, headache
Zelo pogosti: zaspanost, glavobol Bolezni prebavil:
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.
Po 5 letih po osnovnem cepljenju je bil v skupini s cepivom Menveo bistveno večji odstotek oseb s hSBA ≥ 1 : 8 proti vsem seroskupinam kot v skupini necepljenih kontrolnih oseb.
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.
Obstojnost imunskega odziva in odziv po poživitvenem odmerku pri mladostnikih V študiji V59P13E1 so ocenjevali obstojnost imunskega odziva proti seroskupinam A, C, W-135 in Y po 21 mesecih, 3 letih in 5 letih po osnovnem cepljenju pri osebah, ki so bile v času cepljenja stare 11 do 18 let.
In the powder: potassium dihydrogen phosphate and sucrose.
V prašku: kalijev dihidrogen fosfat in saharoza
Menveo Menveo ACWYPS
Menveo Menveo ACWYPS Menveo Menveo ACWYPS
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.
V študiji V59P6E1, eno leto po cepljenju, je odstotek prejemnikov cepiva Menveo s hSBA ≥ 1:8 ostal značilno večji kot pri prejemnikih cepiva ACWY-PS pri seroskupinah C, W-135 in Y, in med študijskima skupinama podoben za seroskupino A. GMT hSBA za seroskupini W-135 in Y so bile višje pri prejemnikih cepiva Menveo.
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
V osrednji, randomizirani, opazovalni slepi študiji V59P20, v kateri so bili sodelujoči stratificirani po starosti (2 do vključno 5 let in 6 do vključno 10 let), so imunogenost enega odmerka cepiva Menveo en mesec po cepljenju primerjali z enim odmerkom ACWY-D.
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).
To cepivo lahko zaščiti le pred bakterijami meningokoka skupin A, C, W-135 in Y. Cepivo ne ščiti pred drugimi vrstami meningokoknih bakterij, razen pred skupinami A, C, W-135 in Y, ali pred drugimi vzroki meningitisa in sepse (zastrupitve krvi).
Table 5: Immunogenicity of one dose of Menveo or ACWY-PS in adolescents, measured at one month post vaccination
Tabela 5: Imunogenost enega odmerka cepiva Menveo ali ACWY-PS pri mladostnikih, merjeno en mesec po cepljenju
hSBA GMTs (95% CI)
GMT hSBA (95 % IZ)
Allergic reactions that may include severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing), difficulty breathing with wheezing or coughing, rash and swelling of the hands, feet and ankles, loss of consciousness, very low blood pressure; fits (convulsions) including fits associated with fever; balance disorder; faint; infection of the skin at the injection site; injection site swelling, including extensive swelling of the injected limb.
Alergijske reakcije, ki lahko vključujejo hudo otekanje ustnic, ust, grla (kar lahko povzroči težave pri požiranju), oteženo dihanje s piskanjem ali kašljanjem, izpuščaj in otekanje dlani, stopal in gležnjev,
In the event of any foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine.
Če v cepivu opazite vidne delce in/ali drugo odstopanje od pričakovanega izgleda, ga zavrzite.
In children (from 2 to 10 years of age), the side effects that were reported during clinical trials are listed below.
Spodaj so našteti najpogostejši neželeni učinki za otroke (od 2 do 10 let starosti), o katerih so poročali v kliničnih preskušanjih.
General disorders and administration site conditions Not known: injection site cellulitis, injection site swelling, including extensive swelling of the injected limb
Neznana pogostnost: celulitis na mestu injiciranja, oteklina na mestu injiciranja, vključno z obsežnim otekanjem cepljenega uda
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
Tabela 3: Obstojnost imunskega odziva po 5 letih po osnovnem cepljenju s cepivom Menveo in imunski odziv 1 mesec po poživitvenem odmerku pri osebah, ki so bile v času osnovnega cepljenja stare 2-5 let oz. 6-10 let
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
Tabela 2: Imunogenost enega odmerka cepiva Menveo ali ACWY-PS pri osebah, starih 2 do vključno 10 let starosti, merjeno en mesec in dvanajst mesecev po cepljenju
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.
Morda vam bo zdravnik ali medicinska sestra še vedno priporočal cepljenje s cepivom Menveo, če je tveganje okužbe z bakterijo meningokoka skupine A, C,
Antibody responses to Menveo and the diphtheria, tetanus or HPV vaccine components were not negatively affected by co-administration.
Sočasno dajanje ne vpliva negativno na odzive protiteles na cepivo Menveo in na sestavine cepiv proti davici, tetanusu ali HPV.
Menveo will be given to you or your child by a doctor or nurse.
Kako uporabljati cepivo Menveo Cepivo Menveo bo vam ali vašemu otroku injiciral zdravnik ali medicinska sestra.
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.
1 leto po cepljenju je bilo cepivo Menveo še naprej statistično višje kot ACWY-PS za seroskupine A, W-135 in Y, izmerjeno v odstotkih oseb s hSBA ≥ 1:8 in GMT.
6-10 years hSBA ≥1:8
6-10 let hSBA ≥1:8
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).
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.
12 months post-vaccination hSBA ≥1:8
12 mesecev po cepljenju hSBA ≥1:8
Common: nausea, vomiting, diarrhea
Pogosti: navzea, bruhanje, driska Bolezni kože in podkožja:
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).
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).
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.
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.
Individuals 11 to 65 years of age
Pri osebah, starih 19-55 let,
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.
V populaciji, stari 11-18 let, so v osrednji študiji V59P13 primerjali imunogenost enojnega odmerka cepiva Menveo en mesec po cepljenju z ACWY-D.
Separate injection sites must be used if more than one vaccine is being administered at the same time.
Če se sočasno aplicira več kot eno cepivo, je treba izbrati ločeni mesti injiciranja.
The powder is a white to off- white cake.
Bela do belkasta pogača praška.
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).
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).
Table 4: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 11-18 years
Tabela 4: Odzivi baktericidnih protiteles v serumu en mesec po cepljenju s cepivom Menveo pri osebah, starih 11-18 let
Table 1: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 2-5 years and 6-10 years
Tabela 1: Odzivi baktericidnih protiteles v serumu en mesec po cepljenju s cepivom Menveo pri osebah, starih 2-5 let in 6-10 let
Potassium dihydrogen phosphate
Prašek saharoza kalijev dihidrogenfosfat
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).
Vsak odmerek cepiva Menveo je na voljo kot: - 1 viala, ki vsebuje komponento liofiliziranega konjugata MenA kot bel do belkast prašek
Musculoskeletal and connective tissue disorders: Common: myalgia, arthralgia General disorders and administration site conditions:
Bolezni mišično-skeletnega sistema in vezivnega tkiva: Pogosti: mialgija, artralgija
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
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).
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).
The solution is a colourless clear solution.
Raztopina je brezbarvna bistra raztopina.
Overall 3464 subjects aged 2 to10 years were exposed to Menveo in completed clinical trials.
V zaključenih kliničnih študijah je bilo cepivo Menveo uporabljeno pri skupno 3.464 osebah,
Table 9: Serum bactericidal antibody responses following Menveo one month after vaccination among subjects aged 19-55 years
Tabela 9: Odzivi baktericidnih protiteles v serumu en mesec po cepljenju s cepivom Menveo pri osebah, starih 19-55 let
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.
temelji na podatkih štirih kliničnih študij, v katerih je bilo s cepivom Menveo cepljenih 3.181 oseb.
There are limited data in individuals aged 56-65 and there are no data in individuals aged >65 years.
Pri odraslih, starih med 56 in 65 let, je na voljo le malo podatkov, za odrasle, starejše od 65 let, pa podatkov ni.
Menveo powder and solution for solution for injection Meningococcal Group A, C, W-135 and Y conjugate vaccine
Menveo prašek in raztopina za raztopino za injiciranje Konjugirano cepivo proti meningokokom skupin A, C, W-135 in Y
Your doctor will tell you if you need an additional injection of Menveo.
Povedal vam bo, če se morate cepiti še enkrat.