natgillin/translations-raw huggingface dataset:
N number of subjects per group n/% number/percentage of subjects reporting a first episode of B-CAP anytime from 2 weeks after the administration of the 3rd dose
N število preiskovancev na skupino n/% število/delež preiskovancev, ki so navedli prvi pojav B-CAP kadar koli od drugega tedna po prejetju tretjega odmerka
Synflorix is always injected into a muscle.
Cepivo Synflorix je treba vedno vbrizgati v mišico.
Synflorix should not be mixed with other vaccines.
Cepiva Synflorix ne smete mešati z drugimi cepivi.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ
Children aged 12 months to 5 years will receive 2 injections.
Otroci v starosti od 12 mesecev do 5 let dobijo 2 injekciji.
These can be recognised by: - raised and itchy rash (hives) - swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing - collapse
- dvignjenem in srbečem izpuščaju (koprivnica) - oteklosti, včasih obraza in ust (angioedem), ki povzroča težave z dihanjem
However if your child has received paracetamol before or immediately after Synflorix is given, the obtained levels of antibodies may be slightly reduced.
Toda če otrok dobi paracetamol pred cepljenjem ali takoj po cepljenju s cepivom Synflorix, so pridobljene ravni protiteles lahko rahlo znižane.
What Synflorix is and what it is used for What you need to know before your child receives Synflorix How Synflorix is given
Kaj je cepivo Synflorix in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok prejel cepivo Synflorix Kako uporabljati cepivo Synflorix
IPD Invasive Pneumococcal Disease
IPB invazivna pnevmokokna bolezen
Your doctor or nurse will inject your child with this vaccine.
Vašega otroka bo s tem cepivom cepil zdravnik ali medicinska sestra.
• fits without temperature or due to high temperature (fever)
• napadi krčev brez zvišane telesne temperature ali zaradi zvišane telesne temperature (vročine)
Synflorix helps your body to make its own antibodies.
Cepivo Synflorix pomaga, da telo ustvari svoja lastna protitelesa.
Immunogenicity following a fourth dose (booster dose) at 15 to 18 months of age was evaluated in 44 very preterm, 69 preterm and 127 full term infants.
Imunogenost po četrtem (obnovitvenem) odmerku pri 15 do 18 mesecih starosti so ocenili pri 44 zelo nedonošenih, 69 nedonošenih in 127 donošenih dojenčkih.
• Synflorix is a turbid white suspension.
• Cepivo Synflorix je motna bela suspenzija.
Usually, your child (from 6 weeks to 6 months of age) will receive a course of 4 injections according to official recommendations or an alternative schedule may be used by the health care professional.
Praviloma bo otrok (od 6 tednov do 6 mesecev starosti) dobil zaporedje 4 injekcij v skladu z uradnimi priporočili, zdravnik pa se lahko odloči tudi za kakšen drugačen razpored.
Booster dose at 9-12 versus 15-18 months of age
Obnovitveni odmerek v starosti od 9 do 12 mesecev v primerjavi z odmerkom v starosti od 15 do 18 mesecev
In both COMPAS and the nested Finnish study, Synflorix reduced vaccine type carriage with an apparent increase in non-vaccine (excluding vaccine-related) serotypes observed after booster.
Tako v študiji COMPAS kot v gnezdeni finski študiji je cepivo Synflorix zmanjšalo nosilstvo tipov, ki so v cepivu, z očitnim povečanjem serotipov, ki jih ni v cepivu (izključujoč s cepivom povezane), po obnovitvenem odmerku.
• high temperature of 38 °C or higher (fever)
• visoka telesna temperatura 38 °C ali več (vročina)
In this age group, serotypes 1, 5 and 7F account for 3.3% to 24.1% of IPD depending on the country and time period studied.
1, 5 in 7F povzročijo v tej starostni skupini od 3,3 do 24,1 % invazivne pnevmokokne bolezni, odvisno od države in proučevanega časovnega obdobja.
(5) in the ATP cohort VE was 100% (95% CI: 74.3; 100; 0 versus 16 cases)
(5) UC v kohorti ATP je bila 100 % (95 % IZ: 74,3; 100; 0 v primerjavi s 16 primeri)
Additional immunogenicity data
Dodatni podatki o imunogenosti
The clinical relevance of this lower post-primary OPA response is not known.
Klinični pomen tega nižjega odziva OPA po primarnem cepljenju ni znan.
There was no impact of co-administration on the other nine pneumococcal serotypes.
Na drugih devet pnevmokoknih serotipov ni bilo vpliva.
Overall, the incidence of IPD was 35/100,000 person-years in those cohorts exposed to Synflorix, and 64/100,000 person-years in those exposed to 7-valent Prevenar, representing a statistically significant difference (p = 0.03).
V celoti je bila incidenca IPB 35/100.000 oseba-let v kohortah, izpostavljenih cepivu Synflorix, in 64/100.000 oseba-let v kohortah, izpostavljenih 7valentnemu cepivu Prevenar; razlika je statistično značilna (p = 0,03).
Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age.
4.1 Terapevtske indikacije Aktivna imunizacija proti invazivnim boleznim, pljučnici in akutnim vnetjem srednjega ušesa, ki jih povzroča Streptococcus pneumoniae pri dojenčkih in otrocih od 6. tedna do 5. leta starosti.
Among children with SCD, 48 children <6 months of age received primary vaccination at 8, 12 and 16 weeks of age, followed by a booster dose at 9-10 months of age, 50 children aged 7-11 months and 48 aged 12-23 months started catch-up vaccination according to their age.
Med otroci z boleznijo srpastih celic je 48 otrok, mlajših od 6 mesecev, prejelo primarno cepljenje pri 8, 12 in 16 tednih starosti ter obnovitveni odmerek pri 9 do 10 mesecih starosti, 50 otrok v starosti od 7 do 11 mesecev in 48 otrok v starosti od 12 do 23 mesecev je začelo naknadno cepljenje skladno s svojo starostjo.
Immunosuppressive therapy and immunodeficiency
Imunosupresivna terapija in imunska pomanjkljivost
In addition, as otitis media and pneumonia are caused by many microorganisms other than the Streptococcus pneumoniae serotypes represented by the vaccine, the overall protection against these diseases is expected to be limited and substantially lower than protection against invasive disease caused by the serotypes in the vaccine and serotype 19A (see section 5.1).
Poleg tega povzročajo vnetje srednjega ušesa in pljučnico še številni drugi mikroorganizmi poleg serotipov Streptococcus pneumoniae, ki so v cepivu, zato je pričakovana zaščita pred tema boleznima omejena in bistveno manjša kot zaščita pred invazivno boleznijo, ki jo povzročajo serotipi v cepivu in serotip 19A (glejte poglavje 5.1).
In a clinical study, it has been demonstrated that Synflorix can be safely administered as a booster dose in the second year of life to children who had received 3 primary doses of 7-valent Prevenar.
Klinična študija je pokazala, da je mogoče cepivo Synflorix varno uporabiti za obnovitveni odmerek v drugem letu življenja pri otrocih, ki so dobili 3 primarne odmerke 7-valentnega cepiva Prevenar.
• In children aged 2 to 5 years that received 1 dose, the ELISA antibody GMCs were similar for 6 vaccine serotypes as well as serotype 19A than those achieved following a 3-dose vaccination schedule in infants below 6 months of age while they were lower for 4 vaccine serotypes (serotypes 1, 5, 14 and 23F).
• Pri otrocih, starih od 2 do 5 let, ki so dobili 1 odmerek, so bile GMC protiteles z ELISA podobne za 6 serotipov v cepivu in za serotip 19A v primerjavi s tistimi doseženimi po shemi cepljenja s 3 odmerki pri dojenčkih mlajših od 6 mesecev, medtem ko so bile za 4 serotipe v cepivu nižje (serotipi 1, 5, 14 in 23F).
However, the clinical relevance of this observation is not known.
Vendar klinični pomen tega opažanja ni znan.
Table 3: Vaccine efficacy against AOM(1) in COMPAS
Preglednica 3: Učinkovitost cepiva proti akutnemu vnetju srednjega ušesa (1) v študiji COMPAS
Special populations:
Posebne skupine:
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Pri zelo nedonošenih dojenčkih (rojenih z 28 tedni gestacije ali manj) se lahko 2 do 3 dni po cepljenju pojavljajo daljši presledki med vdihi, kot je normalno.
In the nested Finnish study, a significant reduction was also observed for individual serotypes 14, 23F and, in the 3 dose primary schedule, for the cross-reactive serotype 19A.
V gnezdeni finski študiji so opažali tudi značilno zmanjšanje individualnih serotipov 14, 23F in, med primarnim zaporedjem cepljenja s 3 odmerki, navzkrižno reaktivnega serotipa 19A.
• itching, blood clot, bleeding or a small lump where the injection is given
• srbečica, krvni strdek, krvavitev ali majhna bula na mestu, kamor je bilo vbrizgano cepivo
Official recommendations for the immunisation against diphtheria, tetanus and Haemophilus influenzae type b should also be followed.
Informacije o zaščiti, ki jo nudi cepivo Vedno je treba upoštevati uradna priporočila za imunizacijo proti davici, tetanusu in Haemophilus influenzae tipa b.
The clinical data suggest that paracetamol might reduce the immune response to Synflorix.
Klinični podatki kažejo, da paracetamol lahko zmanjša imunski odziv na cepivo Synflorix.
In comparative clinical studies, the incidence of local and general adverse events reported within 4 days after each vaccination dose was within the same range as after vaccination with 7-valent Prevenar.
Incidenca lokalnih in splošnih neželenih učinkov, zabeleženih v 4 dneh po vsakem odmerku cepiva, je bila v primerjalnih kliničnih študijah podobna kot po cepljenju s 7-valentnim cepivom Prevenar.
VE Vaccine effectiveness (FinIP) or efficacy (COMPAS) N number of subjects per group
UC učinkovitost cepiva (FinIP - vaccine effectivness in COMPAS - vaccine efficacy) N število preiskovancev na skupino
As with other vaccines, it may be expected that in patients receiving immunosuppressive treatment an adequate response may not be elicited.
Tako kot druga cepiva tudi to cepivo pri imunsko oslabelih bolnikih lahko ne izzove ustreznega odziva.
Uncommon Headache (age 2 to 5 years)
Bolezni prebavil občasni navzea (starost od 2 do 5 let)
Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Synflorix should receive 23-valent pneumococcal polysaccharide vaccine.
Kadar koli je to priporočljivo, morajo ogroženi otroci, stari ≥ 24 mesecev, ki so že primarno dobili cepivo Synflorix, dobiti 23
Immunogenicity and safety of Synflorix were assessed in a limited number of primed or unprimed subjects with congenital or acquired asplenia, splenic dysfunction or complement deficiencies: 6 subjects 2-5 years of age and 40 subjects 6-17 years of age (Synflorix is indicated up to 5 years of age).
Imunogenost in varnost cepiva Synflorix so ocenili pri omejenem številu cepljenih ali necepljenih posameznikov s kongenitalno ali pridobljeno asplenijo, disfunkcijo vranice, pomanjkanjem komplementa: 6 posameznikov je bilo starih 2-5 let in 40 posameznikov 6-17 let (cepivo Synflorix je indicirano do 5. leta starosti).
In a head-to-head comparative trial with 7-valent Prevenar, non-inferiority of the immune response to Synflorix measured by ELISA was demonstrated for all serotypes, except for 6B and 23F (upper limit of the 96.5% CI around the difference between groups >10%) (Table 6).
V neposrednih primerjalnih študijah z odobrenim 7-valentnim cepivom Prevenar, so z meritvami z ELISA dokazali neinferiornost imunskega odziva na cepivo Synflorix za vse serotipe, razen za serotipa 6B in 23F (zgornja meja 96,5 % IZ okrog razlike med skupinama > 10 %) (preglednica 6).
The difference between both vaccines in terms of percentage of subjects with OPA titres ≥ 8 was <5% for all serotypes in common, including 6B and 23F.
Kar zadeva odstotek preiskovancev s titrom OPA ≥ 8, je bila razlika med cepivoma < 5 % za vse skupne serotipe, vključno s 6B in 23F.
For most vaccine serotypes, group comparisons did not suggest any differences in post-primary immune responses between the HIV+/+ and HIV-/- groups, or the HIV+/- and HIV-/- groups, except for a trend towards a lower percentage of subjects reaching OPA titres ≥ 8 and lower OPA GMTs in the HIV+/+ group.
Za večino serotipov v cepivu primerjava skupin ni pokazala nobene razlike v imunskem odzivu po primarnem cepljenju med skupinama HIV+/+ in HIV-/- ali med skupinama HIV+/- in HIV-/-, razen trenda k nižjemu odstotku preiskovancev z doseženimi titri OPA ≥ 8 in nižjo geometrično sredino titrov OPA v skupini HIV+/+.
Any culture confirmed Any vaccine serotype(2)
Povzročena s katerim koli serotipom v cepivu(2)
If you are not sure, talk to your doctor or pharmacist before your child is given Synflorix.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden vaš otrok dobi cepivo Synflorix.
Preterm newborn infants (born between 27-36 weeks gestation)
Nedonošenčki (rojeni med 27 in 36 tedni gestacijske starosti)
The results for protein D suggested comparable post-primary and post-booster immune responses between groups.
Rezultati za protein D so med skupinami pokazali podobne imunske odzive po primarnem cepljenju in po obnovitvenem odmerku.
Vaccine effectiveness or efficacy (VE) was demonstrated in preventing culture-confirmed IPD due to vaccine pneumococcal serotypes when Synflorix was given to infants in either 2+1 or 3+1 schedules in FinIP or 3+1 schedule in COMPAS (see Table 1).
Učinkovitost cepiva (UC - Vaccine effectiveness ali vaccine efficacy) je bila dokazana za preprečitev s kulturo potrjene IPB zaradi pnevmokoknih serotipov v cepivu, če so dojenčki dobili cepivo Synflorix po shemi 2+1 ali 3+1 v FinIP bodisi po shemi 3+1 v COMPAS (glejte preglednico 1).
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to cepivo neželene učinke, ki pa se ne pojavijo pri vseh cepljenih.
Safety and immunogenicity data are available for HIV infected infants (asymptomatic or with mild symptoms according to WHO classification), HIV negative infants born from HIV positive mothers, children with sickle cell disease and children with splenic dysfunction (see sections 4.8 and 5.1).
Na voljo so podatki o varnosti in imunogenosti pri dojenčkih, okuženih s HIV (asimptomatski ali z blagimi simptomi po razvrstitvi Svetovne zdravstvene organizacije), pri HIV-negativnih dojenčkih, rojenih HIV-pozitivnim materam, pri otrocih z boleznijo srpastih celic in pri otrocih z disfunkcijo vranice (glejte poglavji 4.8 in 5.1).
If Synflorix is co-administered with other vaccines, different injection sites should be used.
Če uporabite cepivo Synflorix sočasno z drugimi cepivi, uporabite za injiciranje različna mesta.
0.5 milligram Al3+ in total 2 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
0,5 miligrama Al3+ v celoti konjugiran na nosilno beljakovino D (pridobljena iz netipiziranega Haemophilus influenzae)
In the same study, Synflorix was shown to elicit functional antibodies to all vaccine serotypes.
Ista študija je pokazala, da cepivo Synflorix izzove nastanek funkcionalnih protiteles proti vsem serotipom v cepivu.
In COMPAS, 7,214 subjects [Total Vaccinated cohort (TVC)] were included in the AOM efficacy analysis of which 5,989 subjects were in the ATP cohort (Table 3).
7.214 preiskovancev [celotna cepljena kohorta (TVC - Total Vaccinated cohort)]; od tega je bilo 5.989 preiskovancev v kohorti ATP (preglednica 3).
The vaccine should be well shaken before use.
Cepivo pred uporabo dobro pretresite.
Of these, 76, 96 and 49 infants, respectively, received a booster dose.
76 prvih, 96 drugih in 49 tretjih je prejelo obnovitveni odmerek.
HIV positive (HIV+/+) infants and HIV negative infants born from HIV positive mothers (HIV+/-)
HIV-pozitivni (HIV+/+) dojenčki in HIV-negativni dojenčki, rojeni HIV-pozitivnim materam
9-16 micrograms
9-16 mikrogramov
3 micrograms
3 mikrograme
A booster (third) dose is recommended in the second year of life with an interval of at least 2 months after the last primary dose.
Obnovitveni (tretji) odmerek je priporočljivo dati v drugem letu življenja, vsaj 2 meseca po zadnjem primarnem odmerku.
Severe allergic reactions may very rarely occur (with up to 1 in 10,000 doses of the vaccine).
Zelo redko se lahko pojavijo hude alergijske reakcije (pri največ 1 od 10.000 odmerkov cepiva).
Effectiveness/efficacy in infant cohort below 7 months of age at enrolment
Učinkovitost v kohorti dojenčkov, ob vključitvi mlajših od 7 mesecev
Table 5: Rates of IPD and the corresponding rate reductions in Finland IPD
Preglednica 5: Deleži invazivne pnevmokokne bolezni in ustrezna zmanjšanja deležev na Finskem
The mean duration follow-up from 2 weeks post-dose 3 in the ATP cohort was 23 months (range from 0 to 34 months) for the interim analysis (IA) and 30 months (range from 0 to 44 months) for the end-of-study analysis.
Povprečno trajanje spremljanja od drugega tedna po prejetju tretjega odmerka, je bilo 23 mesecev (razpon od 0 do 34 mesecev) v kohorti po protokolu pri vmesni analizi in 30 mesecev (razpon od 0 do 44 mesecev) pri analizi ob koncu študije.
Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, prenatal exposure to anti-retroviral therapy and/or to HIV, or other causes, may have reduced antibody response to vaccination.
Otroci z oslabljeno imunsko odzivnostjo (naj bo zaradi uporabe imunosupresivnih zdravil, genetske motnje, okužbe s HIV, prenatalne izpostavljenosti protiretrovirusnemu zdravljenju in/ali HIV ali drugih vzrokov) se lahko slabše odzovejo na aktivno imunizacijo.
This study has shown that the immune responses against the 7 common serotypes were comparable to those elicited by a booster dose of 7-valent Prevenar.
Ta študija je pokazala, da so imunski odzivi proti 7 pogostim serotipom primerljivi odzivom, ki jih izzove obnovitveni odmerek 7-valentnega cepiva Prevenar.
Effectiveness in post-marketing surveillance
Učinkovitost med nadzorom po pridobitvi dovoljenja za promet
Your doctor may ask you to give your child a medicine that lowers fever (such as paracetamol) before or immediately after Synflorix is given, especially in children being vaccinated with Synflorix and vaccines containing whole cell pertussis at the same time.
Zdravnik vam bo morda naročil, da otroku pred cepljenjem ali takoj po cepljenju s cepivom Synflorix date zdravilo za znižanje zvišane telesne temperature (vročine) (kot npr. paracetamol), še posebno otrokom, ki so hkrati cepljeni s cepivom Synflorix in polnoceličnimi cepivi proti oslovskemu kašlju.
The functional immune response to serotypes 1 and 5 was lower in magnitude than the response against all other vaccine serotypes.
Funkcionalni imunski odziv na serotipa 1 in 5 je bil manjši kot na vse druge serotipe v cepivu.
In a clinical study conducted in South Africa the immunogenicity of Synflorix administered as a 3-dose primary vaccination course (at 6, 10 and 14 weeks of age) followed by a booster dose (at 9 to 10 months of age) was assessed in 70 HIV positive (HIV+/+) infants, 91 HIV negative infants born from HIV positive mothers (HIV+/-) and 93 HIV negative infants born from HIV negative mothers (HIV-/-).
V klinični študiji v Južni Afriki so imunogenost cepiva Synflorix, uporabljenega za primarno cepljenje s 3 odmerki (pri 6, 10 in 14 tednih starosti), ki mu je sledil obnovitveni odmerek (pri 9 do 10 mesecih starosti), ocenili pri 70 HIV-pozitivnih (HIV+/+) dojenčkih, pri 91 HIV-negativnih dojenčkih, rojenih HIV-pozitivnim materam (HIV+/-), in pri 93 HIV-negativnih dojenčkih, rojenih HIV-negativnim materam (HIV-/-).
Immune responses were compared using non-inferiority criteria in terms of antibody GMC ratio (GMC from group of subjects receiving Synflorix without 2-PE over GMC from group of subjects receiving Synflorix with 2-PE) for each of the 10 vaccine serotypes and for the cross-reactive serotype 19A.
Imunske odzive so primerjali glede neinferiornosti na osnovi razmerja GMC protiteles (GMC skupine, ki je prejela cepivo Synflorix brez 2-PE, napram GMC skupine, ki je prejela cepivo Synflorix z 2-PE) za vsakega izmed 10 serotipov v cepivu in za navzkrižno reaktivni serotip 19A.
The percentage of vaccinees reaching the threshold for the three additional serotypes in Synflorix (1, 5 and 7F) was respectively 97.3%, 99.0% and 99.5% and was at least as good as the aggregate 7-valent Prevenar response against the 7 common serotypes (95.8%).
Odstotki cepljenih, ki so dosegli prag za dodatne tri serotipe v cepivu Synflorix (1, 5 in 7F), so bili 97,3 %, 99,0 % in 99,5 % in so bili vsaj tako dobri kot agregirani odziv proti 7 pogostim serotipom s 7-valentnim cepivom Prevenar (95,8 %).
In COMPAS it was 66.7% (95% CI: 21.8; 85.9; 7 versus 21 cases).
V študiji COMPAS je bila 66,7 % (95 % IZ: 21,8 ; 85,9 ; 7 v primerjavi z 21 primeri).
Control schedule
Kontrole Shema
Following booster vaccination, children > 12 months of age are more likely to experience injection site reactions compared to the rates observed in infants during the primary series with Synflorix.
Po obnovitvenem cepljenju obstaja pri otrocih, starejših od 12 mesecev, večja verjetnost za reakcije na mestu injiciranja v primerjavi z deleži, opaženimi pri dojenčkih med primarnim zaporedjem cepljenja s cepivom Synflorix.
In individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as Human Immunodeficiency Virus (HIV) infection, sickle cell disease (SCD) or splenic dysfunction), Synflorix may be given according to the above mentioned schedules except that a 3-dose schedule should be given as primary vaccination in infants starting vaccination from 6 weeks to 6 months of age (see sections 4.4 and 5.1).
Posameznike, ki so dovzetni za invazivne pnevmokokne bolezni zaradi njihovega zdravstvenega stanja (kot je okužba z virusom humane imunske pomanjkljivosti (HIV), bolezen srpastih celic ali disfunkcija vranice), se lahko cepi s cepivom Synflorix po zgoraj navedenih shemah cepljenja, vendar je pri otrocih, pri katerih se s cepljenjem prične od 6. tedna do 6. meseca starosti, potrebno uporabiti primarno zaporedje cepljenja s tremi odmerki (glejte poglavji 4.4 in 5.1).
Pack size of 1, 10 or 50.
Velikost pakiranja 1, 10 ali 50.
- for children with seizure disorders or with a prior history of febrile seizures.
- za otroke s krči ali anamnezo vročinskih krčev.
The antibody GMCs and OPA GMTs were lower after 2-dose for most vaccine serotypes.
GMC protiteles in GMT OPA so bili po cepljenju z 2 odmerkoma nižji za večino serotipov v cepivu.
The OPA response for serotypes 1 and 5 was lower in magnitude than the response for each of the other serotypes.
Odziv OPA na serotipa 1 in 5 je bil manjši kot odziv proti vsakemu od drugih serotipov.
Immunologic non-inferiority to 7-valent Prevenar
Podatki o imunogenosti Imunološka neinferiornost v primerjavi s 7-valentnim cepivom Prevenar
Immunogenicity of Synflorix containing the preservative 2-phenoxyethanol (2-PE)
Imunogenost cepiva Synflorix, ki vsebuje konzervans 2-fenoksietanol (2-PE)
Among the 15,447 children in the catch-up vaccinated cohorts, there were no culture-confirmed IPD cases in the Synflorix groups while 5 vaccine serotype IPD cases were observed in the control groups (serotypes 4, 6B, 7F, 14 and 19F).
Med 15.447 otroki v kohortah, ki niso zajete v program cepljenja, cepljenih s cepivom Synflorix, ni bilo s kulturo potrjenih primerov IPB, v skupinah, cepljenih s kontrolnim cepivom pa je bilo 5 primerov IPB s serotipi v cepivu (serotipi 4, 6B, 7F, 14 in 19F).
In all trials, Synflorix was administered concurrently with the recommended childhood vaccines.
V vseh preskušanjih so cepivo Synflorix uporabljali hkrati s priporočenimi cepivi za otroke.
Booster doses of Synflorix may increase the risk of side effects.
Obnovitveni odmerki cepiva Synflorix lahko povečajo tveganje za neželene učinke.