natgillin/translations-raw huggingface dataset:
Bactericidal antibody responses one month after the third vaccination against meningococcal reference strains were high against the fHbp, NadA and PorA P1.4 antigens at both Bexsero vaccination schedules.
En mesec po tretjem cepljenju je bil odziv baktericidnih protiteles proti referenčnim sevom meningokokov velik proti antigenom fHbp, NadA in PorA P1.4 v obeh shemah cepljenja s cepivom Bexsero.
Due to an increased risk of fever, tenderness at the injection site, change in eating habits and irritability when Bexsero was co-administered with the above vaccines, separate vaccinations can be considered when possible.
spremembe prehranjevalnih navad in razdražljivosti pri sočasnem dajanju cepiva Bexsero z zgoraj navedenimi cepivi, je, kadar je mogoče, potrebno razmisliti o ločenem cepljenju.
Neck stiffness or uncomfortable sensitivity to light (photophobia), indicating meningeal irritation, has been sporadically reported shortly after vaccination; these symptoms have been of mild and transient nature.
V posamičnih poročilih so poročali o togosti vratu ali neprijetni občutljivosti na svetlobo (fotofobija), ki kažeta na draženje možganskih ovojnic kmalu po cepljenju; ti simptomi so bili blage in prehodne narave.
* pre-booster time point represents persistence of bactericidal antibody at 8 months after Bexsero vaccination at 2, 3 and 4 months of age and 6 months after Bexsero vaccination at 2, 4 and 6 months of age.
* časovna točka pred poživitvenim odmerkom predstavlja perzistenco baktericidnih protiteles 8 mesecev po cepljenju s cepivom Bexsero v starosti 2, 3 in 4 mesecev ter 6 mesecev po cepljenju s cepivom Bexsero v starosti 2, 4 in 6 mesecev.
Name and address of the manufacturer responsible for batch release:
Ime in naslov izdelovalca, odgovornega za sproščanje serij
Not known: syncope or vasovagal responses to injection, meningeal irritation (signs of meningeal irritation, such as neck stiffness or photophobia, have been sporadically reported shortly after vaccination.
Neznana pogostnost: sinkopa ali vazovagalni odzivi na injiciranje, meningealno draženje (o znakih meningealnega draženja, kot so togost vratu ali fotofobija, so sporadično poročali kmalu po cepljenju.
Children 12 months to 23 months of age should receive two injections of the vaccine followed by an additional injection (booster).
Otroci, stari od 12 mesecev do 23 mesecev, morajo prejeti dve injekciji cepiva, ki jima sledi še dodatna injekcija (poživitveni odmerek).
Bexsero is a suspension for injection in pre-filled syringe (Type I glass) with a plunger stopper (Type I bromobutyl rubber) and with a protective tip cap (Type I or Type II rubber) with or without needles.
Cepivo Bexsero je suspenzija za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) z zamaškom na batu (bromobutilna guma tipa I) in z zaščitno zaporko konice (guma tipa I ali tipa II) z ali brez igle.
*** GMT = geometric mean titer.
*** GST = geometrična sredina titrov.
Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 2
50 mikrogramov vezikli zunanje membrane (OMV - outer membrane vesicles) iz Neisseria meningitidis skupine B sev NZ98/254, izmerjeno kot količina skupnih beljakovin, ki vsebuje PorA P1.4 2
Non-clinical data reveal no special hazard for humans based on repeated dose toxicity and reproductive and developmental toxicity studies.
Predklinični podatki na osnovi študij toksičnosti pri ponavljajočih odmerkih ter vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Immunogenicity
Osnovna imunizacija
Serum bactericidal antibody responses at 1 month following the third dose of Bexsero given at 2, 3, 4 or 2, 4, 6 months of age
Odziv serumskih baktericidnih protiteles 1 mesec po tretjem odmerku cepiva Bexsero, danega v starosti 2, 3, 4 ali 2, 4, 6 mesecev
Uncommon: fever (≥40°C)
- zvišana telesna temperatura (≥ 38 °C)
Immunogenicity in infants 2 months to 5 months of age
Imunogenost pri dojenčkih, starih od 2 do 5 mesecev
associated with a skin rash on the trunk of the body, and sometimes followed by a peeling of the skin on the hands and fingers, swollen glands in the neck, red eyes, lips, throat and tongue - Itchy rash, skin rash
- Kawasakijeva bolezen, ki lahko vključuje simptome kot so zvišana telesna temperatura, ki traja več kot pet dni, v povezavi s kožnim izpuščajem na trupu, ki mu včasih sledi luščenje kože na dlaneh in prstih, otekle žleze na vratu, pordele oči, ustnice, žrelo in jezik - srbeč izpuščaj, kožni izpuščaj
Should concomitant administration of other vaccines be necessary, vaccines must be administered at separate injection sites.
Pri sočasnem cepljenju z drugimi cepivi morate cepiva uporabiti na ločenih mestih injiciranja.
In infant studies, participants received three doses of Bexsero either at 2, 4 and 6 or 2, 3 and 4 months of age and a booster dose in their second year of life, as early as 12 months of age.
Imunogenost pri dojenčkih in otrocih V študijah pri dojenčkih so udeleženci prejeli tri odmerke cepiva Bexsero bodisi pri starosti 2, 4 in 6 mesecev bodisi pri starosti 2, 3 in 4 mesece ter poživitveni odmerek v drugem letu življenja od 12. meseca starosti naprej.
The percentages of seropositive subjects (i.e. achieving an hSBA of at least 1:4) across strains ranged from 46% to 95% at one month after the first dose and from 69% to 100% at one month after the second dose (Table 6).
dosežen hSBA vsaj 1:4) je bil za seve v razponu od 46 % do 95 % en mesec po prvem odmerku in od 69 % do 100 % en mesec po drugem odmerku (preglednica 6).
Data on antibody persistence one year after the two doses at 13 and 15 months of age are also summarised in Table 4.
V preglednici 4 so povzeti tudi podatki o perzistenci protiteles eno leto po dveh odmerkih pri starosti 13 in 15 mesecev.
The response to a booster dose administered 4 years after the primary series was indicative of immunological memory as the percentages of subjects with hSBA ≥ 1:5 ranged across strains from 92% to 100%.
Odziv na poživitveni odmerek, uporabljen 4 leta po primarnem zaporedju, je pokazal imunološki spomin, saj so odstotki preiskovancev s hSBA ≥ 1:5 za vse seve segali od 92 do 100 %.
How to store BEXSERO
Shranjevanje cepiva BEXSERO
Percentage of adolescents with seroresponse and at least 4-fold rise in bactericidal titers one month after two doses of Bexsero administered according to different two-dose schedules - stratified by pre-vaccination titers
Preglednica 8: Odstotki mladostnikov s serološkim odzivom in vsaj 4-kratnim porastom baktericidnih titrov en mesec po dveh odmerkih cepiva Bexsero, danima z različnima shemama - stratificirano po titrih pred cepljenjem
General disorders and administration site conditions Very common: fever (≥38°C), injection site tenderness (including severe injection site tenderness defined as crying when injected limb is moved), injection site erythema, injection site swelling, injection site induration, irritability
Zelo pogosti: zvišana telesna temperatura (≥ 38 °C), občutljivost mesta injiciranja (vključno s hudo občutljivostjo na mestu injiciranja, ki je opredeljena kot jok ob premiku cepljenega uda), eritem na mestu injiciranja, oteklina na mestu injiciranja, zatrdlina na mestu injiciranja, razdražljivost
When given at the same time with other vaccines Bexsero must be given at separate injection sites.
Pri sočasnem cepljenju z drugimi cepivi je treba cepivo Bexsero injicirati na ločena mesta.
Serum bactericidal antibody responses following Bexsero vaccination at 6 and 8 months of age or 13 and 15 months of age and persistence of bactericidal antibody one year after the two doses at 13 and 15 months of age
Preglednica 4: Odziv serumskih baktericidnih protiteles po cepljenju s cepivom Bexsero v starosti 6 in 8 mesecev ali 13 in 15 mesecev, ter perzistenca baktericidnih protiteles eno leto po dveh odmerkih, danih v starosti 13 in 15 mesecev
Adolescents (from 11 years of age) and adults should receive two injections of the vaccine.
Mladostniki in odrasli stari 11 let in več ob prvem odmerku Mladostniki (stari 11 let in več) in odrasli morajo prejeti dve injekciji cepiva.
A booster dose should be considered in individuals at continued risk of exposure to meningococcal disease, based on official recommendations d
Skladno z uradnimi priporočili je potrebno razmisliti o poživitvenem odmerku pri posameznikih, ki so izpostavljeni stalnemu tveganju za meningokokno bolezen.
The immunogenicity after two primary doses (at 3 and a half and 5 months of age) or three primary doses (at 2 and a half, 3 and a half and 5 months of age) of Bexsero followed by a booster dose in infants starting vaccination between 2 and 5 months of age has been evaluated in an additional phase 3 clinical study.
Zaporedje cepljenja z dvema odmerkoma, ki mu sledi poživitveni odmerek Imunogenost po dveh odmerkih osnovnega cepljenja (pri 3 mesecih in pol in pri 5 mesecih starosti) ali treh odmerkih osnovnega cepljenja (pri 2 mesecih in pol, pri 3 mesecih in pol in pri 5 mesecih starosti) s cepivom Bexsero, ki jim sledi poživitveni odmerek, so pri dojenčkih, ki so s cepljenjem začeli med
Immunogenicity in adolescents (from 11 years of age) and adults
Imunogenost pri mladostnikih (starih več kot 11 let) in odraslih
The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Pri dajanju odmerkov po osnovni imunizacijski shemi zelo prezgodaj rojenim dojenčkom (rojenim z ≤ 28 tedni gestacijske starosti) in zlasti tistim z nezrelostjo dihal v anamnezi morate upoštevati tveganje pojava apneje in potrebo po spremljanju dihal za 48-72 ur.
Serum bactericidal antibody responses following a booster at 12 months after a primary series administered at 2, 3 and 4 or 2, 4 and 6 months of age, and persistence of bactericidal antibody one year after the booster
Preglednica 3: Odziv serumskih baktericidnih protiteles po poživitvenem odmerku 12 mesecev po osnovnem cepljenju v starosti 2, 3 in 4 mesecev ali 2, 4 in 6 mesecev, ter perzistenca baktericidnih protiteles eno leto po poživitvenem odmerku
0, 2 months
Pri 0, 1 mesecu Pri 0, 2 meseci h
A two-dose schedule followed by a booster has been evaluated in infants 3 months to 5 months of age in a clinical study.
Zaporedje cepljenja z dvema odmerkoma, ki mu sledi poživitveni odmerek, so ocenjevali v klinični študiji pri dojenčkih, starih od 3 do 5 mesecev.
Yes, one dose between 12 and 15 months of age with an interval of at least 6 months between the primary series and booster dose b, c
od 2 do 5 mesecev a trije odmerki po 0,5 ml vsaj 1 mesec da, en odmerek med 12. in 15. mesecem starosti s presledkom vsaj 6 mesecev med osnovnim cepljenjem in poživitvenim odmerkom b, c dojenčki, od 3 do 5
These observations are consistent with adequate priming in infancy with both a two-dose and a threedose primary series followed by a booster of Bexsero.
Ta opažanja kažejo ustreznost primarnega cepljenja v obdobju dojenčka tako z dvema kot s tremi odmerki cepiva Bexsero, ki jim(a)
The immunogenicity after two doses administered two months apart in children 6 months to 23 months of age has been documented in two studies whose results are summarised in Table 4.
Imunogenost pri dojenčkih, starih od 6 do 11 mesecev in otrocih od 12 do 23 mesecev Imunogenost po dveh odmerkih, danih otrokom, starim od 6 do 23 mesecev, s presledkom dveh mesecev, so ugotavljali v dveh študijah, katerih rezultati so povzeti v preglednici 4.
As with any vaccine, Bexsero may not fully protect all of those who are vaccinated.
Kot druga cepiva tudi cepivo Bexsero ne zagotovi nujno zaščite pri vseh cepljenih osebah.
12 to 23 months of age Age of vaccination 6, 8 months
Starostni razpon starost od 6 do 11 mesecev starost od 12 do 23 mesecev Starost pri cepljenju pri 6, 8 mesecih pri 13, 15 mesecih fHbp
% seropositive (95% CI) hSBA GMT (95% CI) * % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:4.
% seropozitivnih* (95 % IZ) hSBA GST (95 % IZ) * % seropozitivnih = odstotek preiskovancev, ki so dosegli rezultat hSBA ≥ 1:4.
Not less than 1 month
ki lahko vztraja več kot en mesec)
Even if you or your child have been vaccinated with Bexsero you or your child remain at increased risk of disease caused by the Neisseria meningitidis group B bacteria.
Bexsero, imate, ima vaš otrok še vedno večje tveganje za bolezen, ki jo povzročajo bakterije
Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed)
Bexsero suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti meningokokom skupine B (rekombinantno, komponentno, adsorbirano)
- If you get any side effects talk to your doctor or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali medicinsko sestro.
2, 4, 6, 12 months fHbp pre-booster* % seropositive** (95% CI) hSBA GMT*** (95% CI)
Antigen pri 2, 3, 4, 12 mesecih pri 2, 4, 6, 12 mesecih fHbp pred poživitvenim odmerkom* % seropozitivnih** (95 % IZ) hSBA GST*** (95 % IZ)
What you need to know before you or your child receive BEXSERO
Kaj morate vedeti, preden boste vi ali vaš otrok prejeli cepivo BEXSERO NE uporabljajte cepiva Bexsero:
% 4-fold increase after 2nd dose
% s 4-kratnim porastom po 2. odmerku (95 % IZ)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bexsero suspension for injection
IME ZDRAVILA IN POT(I) UPORABE Bexsero suspenzija za injiciranje cepivo proti meningokokom B i.m.
Against each of the vaccine antigens, seroresponse rates and hSBA GMTs were high and similar after the two-dose series in infants 6-8 months of age and children 13-15 months of age.
Po zaporednem cepljenju z dvema odmerkoma so bile stopnje serološkega odziva in vrednosti GST pri hSBA proti vsem antigenom cepiva visoke in podobne pri dojenčkih, starih od 6 do 8 mesecev in otrocih,
Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4
50 mikrogramov vezikli zunanje membrane (OMV - outer membrane vesicles) iz Neisseria meningitidis skupine B sev NZ98/254, izmerjeno kot količina skupnih beljakovin, ki vsebuje
* % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:4.
* % seropozitivnih = odstotek preiskovancev, ki je doseglo rezultat hSBA ≥ 1:4.
Serum bactericidal antibody responses in adults after two doses of Bexsero administered according to different two-dose schedules
Preglednica 9: Odziv serumskih baktericidnih protiteles pri odraslih po dveh odmerkih cepiva Bexsero, danih z različnima shemama
% seropositive* (95% CI)
% seropozitivnih* (95 % IZ)
QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (0.5 ml) contains:
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo Bexsero En odmerek (0,5 ml) vsebuje:
Uncommon: pallor (rare after booster) Rare: Kawasaki syndrome
Redki: Kawasakijev sindrom Bolezni prebavil
The bactericidal responses against the NHBA antigen were also high in infants vaccinated at the 2, 4, 6-month schedule, but this antigen appeared to be less immunogenic at the 2, 3, 4-month schedule.
cepljenih v shemi 2, 4, 6 mesecev, vendar izgleda, da je ta antigen manj imunogen v shemi 2, 3, 4 mesecev.
Fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection.
Kot odziv na vbod z iglo se lahko pojavijo omedlevica, omotica ali druge s stresom povezane reakcije.
The response to a booster dose administered 7.5 years after the primary series was indicative of immunological memory as the percentages of subjects reaching an hSBA ≥ 1:4 across strains ranged from 93% to 100%.
7,5 leta po primarnem zaporedju, je pokazal imunološki spomin, saj so odstotki seropozitivnih preiskovancev, ki so dosegli hSBA ≥ 1:4 za vse seve segali od 93 do 100 %.
A decline in antibody titers to PorA P1.4 and fHbp antigens (reaching 9%-10% and 12%-20% of subjects with an hSBA ≥ 1:5, respectively) has been observed in an additional study in children 4 years of age who received a full priming and booster schedule as infants.
V dodatni študiji pri otrocih, starih 4 leta, ki so kot dojenčki prejeli celotno osnovno in poživitveno shemo, so opazili padec titra protiteles proti antigenoma PorA P1.4 in fHbp (pri 9−10 % oziroma 12−20 % preiskovancih z rezultatom hSBA ≥ 1:5).
% seropositive (95% CI)
% seropozitivnih (95 % IZ)
Serum bactericidal antibody responses in adolescents one month after two doses of Bexsero administered according to different two-dose schedules and persistence of bactericidal antibody 18 to 23 months after the second dose
Preglednica 7: Odziv serumskih baktericidnih protiteles pri mladostnikih en mesec po dveh odmerkih cepiva Bexsero, danima z različnima shemama, in obstojnost baktericidnih protiteles 18 do 23 mesecev po drugem odmerku
** % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:5.
** % seropozitivnih = odstotek preiskovancev, ki je doseglo rezultat hSBA ≥ 1:5.
Infants 6 months to 11 months of age should receive two injections of the vaccine followed by an additional injection (booster).
Dojenčki, stari od 6 do 11 mesecev ob prvem odmerku Dojenčki, stari od 6 do 11 mesecev, morajo prejeti dve injekciji cepiva, ki jima sledi še dodatna injekcija (poživitveni odmerek).
hSBA GMT (95% CI)
hSBA GMT (95 % IZ)
Serum bactericidal antibody responses to each of the vaccine antigens NadA, fHbp, NHBA and PorA P1.4 was evaluated using a set of four meningococcal group B reference strains.
Imunogenost Odzivi serumskih baktericidnih protiteles na antigene cepiva NadA, fHbp, NHBA in PorA P1.4 so ocenili s pomočjo kompleta štirih referenčnih sevov meningokokov skupine B. Baktericidna protitelesa proti tem sevom so izmerili s testom baktericidnosti seruma s človeškim serumom kot virom komplementa
These bacteria can cause serious, and sometimes life-threatening, infections such as meningitis (inflammation of the covering of the brain and spinal cord) and sepsis (blood poisoning).
Cepivo Bexsero se daje osebam, starim 2 meseca ali več, za zaščito pred boleznijo, ki jo povzroča bakterija Neisseria meningitidis skupine B. Ta bakterija lahko povzroči hude in včasih smrtno nevarne okužbe, kot sta meningitis (vnetje ovojnic možganov in hrbtenjače) in sepsa (okužba krvi).
ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET
No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the vaccination series.
Pri nadaljnjih odmerkih sheme cepljenja niso opazili povečanja pojavnosti ali resnosti neželenih učinkov.
6 to 10 years of age fHbp
Antigen starost od 2 do 5 let starost od 6 do 10 let fHbp
Fever (adolescents from 11 years of age and adults).
Zvišano telesno temperaturo (mladostniki, starejši od 11 let, in odrasli).
hSBA GMT** (95% CI)
hSBA GMT** (95 % IZ)
% seropositive (95% CI) hSBA GMT (95% CI) * % seropositive = the percentage of subjects who achieved an hSBA ≥ 1:4 (in the 6 to 11 months range of age) and an hSBA ≥ 1:5 (in the 12 to 23 months range of age).
* % seropozitivnih = odstotek preiskovancev, ki je doseglo rezultat hSBA ≥ 1:4 (v razponu od 6 do 11 mesecev starosti) oz. hSBA ≥ 1:5 (v razponu od 12 do 23 mesecev).
The vaccine should be visually inspected for particulate matter and discoloration prior to administration.
Cepivo je treba pred uporabo pregledati s prostim očesom za prisotnost delcev in spremembo barve.
There was no evidence of maternal or foetal toxicity, and no effects on pregnancy, maternal behaviour, female fertility, or postnatal development in a study in which female rabbits received Bexsero at approximately 10 times the human dose equivalent based on body weights.
V študiji na kunčjih samicah, ki so prejele cepivo Bexsero v odmerku, ki je približno 10-krat večji od človeškega ekvivalenta na osnovi telesne mase, niso ugotovili dokazov toksičnosti za mater ali plod oz. učinkov na brejost, obnašanje matere, plodnost samic ali postnatalni razvoj.
NAME OF THE MEDICINAL PRODUCT Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed)
Navodilo za uporabo Bexsero suspenzija za injiciranje v napolnjeni injekcijski brizgi cepivo proti meningokokom skupine B (rekombinantno, komponentno, adsorbirano)
General disorders and administration site conditions Very common: injection site pain (including severe injection site pain defined as unable to perform normal daily activity), injection site swelling, injection site induration, injection site erythema, malaise
Zelo pogosti: bolečina na mestu injiciranja (vključno s hudo bolečino na mestu injiciranja, ki je opredeljena kot nezmožnost opravljanja običajnih dnevnih dejavnosti), oteklina na mestu injiciranja, zatrdlina na mestu injiciranja, eritem na mestu injiciranja, slabo počutje Neznana pogostnost: zvišana telesna temperatura, reakcije na mestu injiciranja (vključno z obsežno oteklino cepljenega uda, mehurji na mestu injiciranja ali okoli njega in nodulom na mestu injiciranja,
Ask your doctor for advice whether it is beneficial for you to receive Bexsero.
Posvetujte se s svojim zdravnikom ali medicinsko sestro, ali je cepljenje s cepivom Bexsero koristno za vas.
% seropositive (95% CI) hSBA GMT (95% CI) 18-23 months after 2nd dose
% seropozitivnih (95 % IZ) hSBA GST (95 % IZ) 18-23 mesecev po 2. odmerku
Seroresponse rates and percentages of subjects with at least a 4-fold increase in hSBA titer from baseline to one month after the second dose of Bexsero are summarised in Table 8.
V preglednici 8 so povzete stopnje serološkega odziva in odstotki preiskovancev, ki jim je titer hSBA od izhodišča do enega meseca po drugem odmerku cepiva Bexsero porasel za vsaj 4-krat.
Higher rates of antipyretic use were also reported for infants vaccinated with Bexsero and routine vaccines.
Pri dojenčkih, cepljenih s cepivom Bexsero in rutinskimi cepivi, je bila ugotovljena tudi večja pogostnost uporabe antipiretikov.
% seropositive* (95% CI) hSBA GMT** (95% CI) 18-23 months after 2nd dose
% seropozitivnih* (95 % IZ) hSBA GST** (95 % IZ) 18−23 mesecev po 2. odmerku
Recombinant Neisseria meningitidis group B fHbp fusion protein 1, 2, 3
50 mikrogramov rekombinantna fuzijska beljakovina fHbp iz Neisseria meningitidis skupine B 1, 2, 3
Persistence of the immune response one year after the booster dose is also presented in Table 3.
V preglednici 3 so prikazani tudi podatki o perzistenci imunskega odziva eno leto po poživitvenem odmerku.
Contents of the pack and other information
Shranjevanje cepiva Bexsero Vsebina pakiranja in dodatne informacije
% seropositive (95% CI) hSBA GMT (95% CI) 12 months after 2nd dose
% seropozitivnih (95 % IZ) hSBA GST (95 % IZ) 12 mesecev po 2. odmerku
% seropositive* (95% CI) hSBA GMT** (95% CI) 12 months after 2nd dose
% seropozitivnih* (95 % IZ) hSBA GST** (95 % IZ) 12 mesecev po 2. odmerku
Adolescents (from 11 years of age) and adults
Mladostniki (stari 11 let in več) in odrasli
Ask your doctor or nurse how to throw away medicines you no longer use.
O načinu odstranjevanja cepiva, ki ga ne uporabljate več, se posvetujte z zdravnikom ali medicinsko sestro.
- The first injection should be given no earlier than 2 months of age if three initial doses are given; the interval between injections should be at least 1 month.
- Prve injekcije ne smete dati pred 2 mesecema starosti, če so dani trije osnovni odmerki;
12 months after booster % seropositive (95% CI) hSBA GMT (95% CI)
12 mesecev po poživitvenem odmerku % seropozitivnih (95 % IZ) hSBA GST (95 % IZ)
Two doses each of 0.5 ml
mesecev dva odmerka po 0,5 ml vsaj 2 meseca dojenčki,
Age at first dose Primary Immunisation
Preglednica 1: Povzetek odmerjanja Starost ob prvem odmerku