natgillin/translations-raw huggingface dataset:
After the booster dose a lower percentage of subjects with OPA titres ≥ 8 was observed in the 2-dose schedule for serotypes 5 (87.2% versus 97.5% for the 3dose primed subjects) and 6B (81.1% versus 90.3%), all other responses were comparable.
Po obnovitvenem odmerku je bil odstotek preiskovancev s titri OPA ≥ 8 manjši med tistimi, ki so dobili 2 odmerka, kot med tistimi, ki so primarno dobili 3 odmerke za serotipa 5 (87,2 % v primerjavi s 97,5 %) in 6B (81,1 % v primerjavi z 90,3 %).
The percentage of subjects with OPA titres ≥ 8 and GMTs observed post-primary and postbooster were lower in the 2-dose schedule than that in the 3-dose schedule.
Odstotek preiskovancev s titri OPA ≥ 8 in geometrijsko sredino titrov opaženo po primarnem cepljenju in po obnovitvenem odmerku je bil ob shemi z 2 odmerkoma nižji kot ob shemi s 3 odmerki.
Each injection will be given at least one month apart.
Med injekcijama cepiva mora miniti vsaj en mesec.
Anti-1 97.4 Anti-4 98.0 Anti-5 96.1 Anti-6B 55.7 Anti-7F 96.7 Anti-9V 93.4 Anti-14 96.1 Anti-18C 96.1 Anti-19F 92.8 Anti-23F 69.3
proti-1 97,4 proti-4 98,0 proti-5 96,1 proti-6B 55,7 proti-7F 96,7 proti-9V 93,4 proti-14 96,1 proti-18C 96,1 proti-19F 92,8 proti-23F 69,3
What you need to know before your child receives Synflorix
Kaj morate vedeti, preden bo vaš otrok prejel cepivo Synflorix Vaš otrok cepiva Synflorix ne sme prejeti:
In the study conducted in South Africa, the booster dose given at 9-10 months of age induced marked increases in antibody GMCs and OPA GMTs for each vaccine serotype and serotype 19A in both 2dose and 3-dose priming groups indicative of immunological priming.
V študiji v Južni Afriki je obnovitveni odmerek, uporabljen v starosti od 9 do 10 mesecev, povzročil izrazito povečanje GMC protiteles in GMT OPA za vse serotipe v cepivu in za serotip 19A tako med otroki, primarno cepljenimi z 2 odmerkoma, kot med otroki, primarno cepljenimi s tremi odmerki; to kaže na imunološko pripravo (priming).
• Synflorix is available in vials for 2 doses in a pack of 100.
• Cepivo Synflorix je na voljo v vialah z 2 odmerkoma v pakiranju po 100.
The content of the vial should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Pred pretresanjem in po njem morate vsebino viale pred uporabo pregledati in se prepričati, da ne vsebuje delcev in/ali ni nenormalnega videza.
Very common (these may occur with more than 1 in 10 doses of the vaccine)
Zelo pogosti (pojavi se lahko pri več kot 1 od 10 odmerkov cepiva)
Table 8: Percentage of 3-dose primed subjects with antibody concentrations ≥ 0.20 µg/ml one month post-primary and one month post-booster Antibody
Preglednica 8: Odstotek preiskovancev, ki so prejeli primarno 3 odmerke, s koncentracijo protiteles ≥ 0,20 µg/ml en mesec po prvem odmerku in en mesec po obnovitvenemu odmerku
CI Confidence Interval (1) First episode (2) Follow up period for a maximum of 40 months from 2 weeks after third primary dose (3) Not statistically significant by pre-defined criteria (One sided p=0.032).
IZ interval zaupanja (1) Prvi pojav (2) Obdobje spremljanja največ 40 mesecev od 2 tednov po tretjem primarnem odmerku
Pneumococcal polysaccharide serotype 9V1,2
Pnevmokokni polisaharid serotip 9V1,2
Safety and immunogenicity data for Synflorix are not available for individuals in other specific immunocompromised groups and vaccination should be considered on an individual basis (see section
Podatkov o varnosti in imunogenosti cepiva Synflorix pri posameznikih z drugo obliko imunske oslabelosti ni na voljo.
The results of the COMPAS study, which was performed in Latin America, should be interpreted with caution due to possible differences in epidemiology of pneumonia in different geographical locations.
Zaradi razlik v epidemiologiji pljučnice na različnih geografskih področjih je potrebna previdnost pri interpretaciji rezultatov študije COMPAS, izvedene v Latinski Ameriki.
(2) the 2 groups of control clusters of infants were pooled (3) p-value<0.0001 (4) p-value=0.0009
(4) vrednost p = 0,0009
Synflorix schedule
Synflorix Shema
Based on 1.5 years of surveillance following Synflorix introduction, with over 90% coverage in the vaccine-eligible age group, a decrease in vaccine serotype IPD incidence (largely due to changes in serotype 7F disease) was observed with no concomitant increase in non-vaccine serotype IPD incidence.
pokritosti starostne skupine, primerne za cepljenje, so opažali zmanjšanje incidence IPB s serotipi v cepivu (v veliki meri zaradi sprememb bolezni s serotipom 7F), brez sočasnega povečanja incidence
MARKETING AUTHORISATION NUMBER(S) EU/1/09/508/006 - pack of 1
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/09/508/006 - pakiranje po 1
Table 7: Percentage of 2-dose primed subjects with antibody concentrations ≥ 0.20 µg/ml one month post-primary and one month post-booster Antibody
Preglednica 7: Odstotek preiskovancev, ki so prejeli primarno 2 odmerka, s koncentracijo protiteles ≥ 0,20 µg/ml en mesec po prvem odmerku in en mesec po obnovitvenemu odmerku
Non-inferiority was demonstrated as the upper limit of the 2-sided 95% CI of the antibody GMC ratios was below 2 for each of the 10 vaccine serotypes and for serotype 19A.
Neinferiornost je bila dokazana za vsakega izmed 10 serotipov v cepivu in za serotip 19A, ker je bila zgornja meja 2-stranskega 95 % IZ za razmerje GMC protiteles nižja od 2.
In COMPAS, serotypes 5 (2 cases), 18C (4 cases) and 23F (1 case) were detected in control group in addition to serotypes 6B and 14.
14 odkrili še serotipe 5 (2 primera), 18C (4 primeri) in 23F (1 primer).
MARKETING AUTHORISATION NUMBER(S) EU/1/09/508/012 - pack of 10
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/09/508/012 - pakiranje po 10
4-dose container Sodium chloride 2-phenoxyethanol Water for injections
Vsebnik s 4 odmerki natrijev klorid 2-fenoksietanol voda za injekcije
A clinical study conducted in South Africa assessed the immunogenicity of Synflorix after 3-dose (610-14 weeks of age) or 2-dose (6-14 weeks of age) priming followed by a booster dose at 9-10 months of age.
V klinični študiji v Južni Afriki so ocenili imunogenost cepiva Synflorix pri otrocih, ki so opravili primarno cepljenje s 3 odmerki (v starosti 6, 10 in 14 tednov) ali z 2 odmerkoma (v starosti 6 in 14 tednov) in so prejeli obnovitveni odmerek v starosti od 9 do 10 mesecev.
Store in the original package in order to protect from light Should be used within 6 hours after first broaching of the vial
Uporabiti morate v 6 urah po prvem vbodu v vialo.
In the second clinical study, a single dose administered four months after two catch-up doses at 12-20 months of age elicited a marked increase of ELISA GMCs and OPA GMTs (when comparing the responses pre and post the last dose), indicating that two catch-up doses provide adequate priming.
Čez štiri mesece so prejeli en odmerek, ki je izzval izrazit porast ELISA GMC in GMT OPA (če primerjamo odziv pred in po zadnjem odmerku); to kaže, da dva naknadna odmerka zagotavljata ustrezno pripravo (priming).
Pneumococcal polysaccharide serotype 6B1,2
Pnevmokokni polisaharid serotip 6B1,2
However, children who received 7-valent Prevenar for the primary series would not be primed against the additional serotypes contained in Synflorix (1, 5, 7F).
Toda otroci, ki dobijo 7-valentno cepivo Prevenar za primarno zaporedje, ne bodo imeli priprave proti dodatnim serotipom, ki jih vsebuje cepivo
In clinical trials, Synflorix elicited an immune response to all ten serotypes included in the vaccine, but the magnitude of the responses varied between serotypes.
V kliničnih preskušanjih je cepivo Synflorix izzvalo imunski odziv na vseh deset serotipov v cepivu,
In the catch-up cohorts, children between 7-11 months of age at first vaccine dose received Synflorix or hepatitis B control vaccine according to a 2-dose primary schedule followed by a booster dose and children between 12-18 months of age at first vaccine dose received 2 doses of either Synflorix or hepatitis A control vaccine.
V kohortah, ki niso zajete v program cepljenja, so otroci, v starosti od 7 do 11 mesecev, ob prvem odmerku cepiva dobili cepivo Synflorix ali kontrolno cepivo proti hepatitisu B po primarnem zaporedju z 2 odmerkoma in nato obnovitveni odmerek.
• Synflorix is available in vials for 4 doses in packs of 10 or 100.
• Cepivo Synflorix je na voljo v vialah s 4 odmerki v pakiranjih po 10 ali 100.
EU/1/09/508/013 - pack of 100
EU/1/09/508/013 - pakiranje po 100
A clinical study conducted in India assessing a booster dose given at 9-12 or 15-18 months of age in 66 and 71 children, respectively, following primary vaccination at 6, 10 and 14 weeks of age, did not suggest differences between groups in terms of antibody GMCs.
12 mesecev in pri 71 otrocih v starosti od 15 do 18 mesecev, ki so opravili primarno cepljenje v starosti 6, 10 in 14 tednov; izsledki niso pokazali razlike med skupinama, kar zadeva GMC protiteles.
Serotype 6B IPD 0
IPB s serotipom 6B
Anti-6B 63.1 Anti-7F 99.3 Anti-9V 99.3 Anti-14 100 Anti-18C 99.3 Anti-19F 96.1 Anti-23F 77.6
proti-1 98,7 proti-4 99,3 proti-5 100 proti-6B 63,1 proti-7F 99,3 proti-9V 99,3 proti-14 100 proti-18C 99,3 proti-19F 96,1 proti-23F 77,6
Studies with an 11-valent vaccine formulation representative for Synflorix revealed no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity.
5.3 Predklinični podatki o varnosti Na osnovi običajnih študij farmakološke varnosti pri enkratnem in ponavljajočih se odmerkih, študije z 11-valentno formulacijo, ki je reprezentativna cepivu Synflorix, ne kažejo posebnega tveganja za človeka.
In addition when the meningococcal serogroups A, C, W-135 and Y vaccine (TT conjugate) was coadministered with a booster dose of Synflorix during the second year of life in children primed with 3 doses of Synflorix, lower antibody geometric mean concentration (GMC) and opsonophagocytic assay geometric mean titre (OPA GMT) were observed for one pneumococcal serotype (18 C).
Poleg tega so za en pnevmokokni serotip (18 C) opažali nižjo geometrijsko sredino koncentracije (GMCgeometric mean concentration) protiteles in nižjo geometrijsko sredino titrov na opsonofagocitnem preizkusu (OPA GMT - opsonophagocytic assay geometric mean titre), če je bilo cepivo proti meningokokom seroloških skupin A, C, W-135 in Y (konjugat TT) uporabljeno sočasno z obnovitvenim odmerkom cepiva Synflorix v drugem letu življenja pri otrocih, ki so primarno dobili 3 odmerke cepiva Synflorix.
Pneumococcal polysaccharide serotype 19F1,4
Pnevmokokni polisaharid serotip 19F1,4
In both schedules, a booster response indicative of immunological priming was observed for each vaccine serotype (Table 7 and Table 8).
Pri obeh časovnih razporedih so zabeležili odziv na obnovitveni odmerek za vsak serotip v cepivu (preglednica
Very rare:
Zelo pogosti:
For each of the seven serotypes in common, 87.7% to 100% of Synflorix vaccinees and 92.1% to 100% of 7-valent Prevenar vaccinees reached an OPA titre ≥ 8 one month after the third dose.
En mesec po tretjem odmerku je titer OPA ≥ 8 proti vsakemu od sedmih skupnih serotipov doseglo od 87,7 % do 100 % preiskovancev, cepljenih s cepivom Synflorix, in od 92,1 % do 100 % preiskovancev, cepljenih s 7-valentnim cepivom Prevenar.
Non-typeable Haemophilus influenzae (NTHi)
10 pnevmokoknih serotipov v cepivu Netipizirani Haemophilus influenzae (NTHi) 15,0 %(4)
Only HIV+/+ infants with WHO classification stage 1 (asymptomatic) or 2 (mild symptoms) were to be enrolled.
Vključeni so bili le dojenčki s HIV+/+, ki so bili po razvrstitvi Svetovne zdravstvene organizacije v 1.
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in pre-filled syringe 1 pre-filled syringe
FARMACEVTSKA OBLIKA IN VSEBINA suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga 1 odmerek (0,5 ml)
CI Confidence Interval (1) In FinIP apart from serotypes 6B and 14, culture-confirmed vaccine serotype IPD cases included 7F (1 case in the Synflorix 2+1 clusters), 18C, 19F and 23F (1 case of each in the control clusters).
in 14 še serotipi 7F (1 primer v klastrih s cepivom Synflorix 2+1), 18C, 19F in 23F (1 primer vsakega v kontrolnih klastrih).V študiji COMPAS so v kontrolni skupini poleg serotipov 6B in
Adjusted Effectiveness(2) % (95% CI)
Učinkovitost je bila 100 % (95 %
Pharmacotherapeutic group: vaccines, pneumococcal vaccines, ATC code: J07AL52
Oznaka ATC: J07AL52
The percentage of subjects with OPA titres ≥ 8 in 2-dose primed subjects compared to 3-dose primed subjects were lower for serotypes 6B, 18C and 23F (74.4%, 82.8%, 86.3% respectively for the 2-dose schedule and 88.9%, 96.2%, 97.7% respectively for the 3-dose schedule).
Za serotipe 6B, 18C in 23F je bil med preiskovanci, ki so primarno dobili 2 odmerka, manjši odstotek takšnih s titri OPA ≥ 8 (74,4 %, 82,8 %, 86,3 % po serotipih), kot med preiskovanci, ki so primarno dobili 3 odmerke (88,9 %, 96,2 %, 97,7 % po serotipih).
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in multidose container (4 doses) 10 MULTIDOSE vials (4 doses per vial - 0.5 ml per dose) 100 MULTIDOSE vials (4 doses per vial - 0.5 ml per dose)
suspenzija za injiciranje v večodmernem vsebniku (4 odmerki) 10 VEČODMERNIH vial (4 odmerki na vialo - 0,5 ml na odmerek)
Pneumococcal polysaccharide serotype 23F1,2
Pnevmokokni polisaharid serotip 23F1,2
In children as of 2 years of age, fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if your child fainted with a previous injection.
Pri otrocih, starejših od 2 let, se lahko pojavi omedlevica po vsakem injiciranju z iglo ali celo pred njim.
Anti-6B 1100 65.9 372 79.0 13.12 7.53 18.28 Anti-9V 1103 98.1 374 99.5
Anti-6B 1100 65,9 372 79,0 13,12 Anti-9V 1103 98,1 374 99,5 1,37 Anti-14 1100 99,5 374 99,5 -0,08 Anti-18C 1102 96,0 374 98,9 2,92 Anti-19F 1104 95,4 375 99,2 3,83 Anti-23F 1102 81,4 374 94,1 12,72
• Synflorix is available in vials for 1 dose in packs of 1, 10 or 100
• Cepivo Synflorix je na voljo v vialah z 1 odmerkom v pakiranjih po 1, 10 ali 100.
The vaccine is a turbid white suspension.
FARMACEVTSKA OBLIKA suspenzija za injiciranje (injekcija) Cepivo je motna bela suspenzija.
• Kawasaki disease (major signs of the illness are for instance: fever, skin rash, swollen lymph glands, inflammation and rash of the mucous membranes of the mouth and throat)
• Kawasakijeva bolezen (pomembnejši znaki bolezni so npr.: povišana telesna temperatura,
The content of the pre-filled syringe should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Pred pretresanjem in po njem morate vsebino napolnjene injekcijske brizge pred uporabo pregledati in se prepričati, da ne vsebuje delcev in/ali ni nenormalnega videza.
This is usually in the thigh or upper arm.
Praviloma ga bo zdravnik vbrizgal v stegno ali nadlaht.
Pre-filled syringe
Pokrovček brizge
Alternatively, when Synflorix is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5 ml may be given.
Če je cepivo Synflorix uporabljeno v okviru rutinskega programa cepljenja dojenčkov, je druga možnost uporaba zaporedja s tremi odmerki po 0,5 ml. Prvi odmerek se lahko da že pri 6 tednih starosti, drugi odmerek pa se uporabi 2 meseca pozneje.
In preterm infants born after at least 27 weeks of gestational age, the recommended immunisation series consists of four doses, each of 0.5 ml.
Pri nedonošenčkih, rojenih z vsaj 27 tedni gestacijske starosti, obsega priporočeno imunizacijsko zaporedje štiri odmerke po 0,5 ml. Primarno zaporedje za dojenčke obsega tri odmerke, pri čemer je prvi odmerek uporabljen pri 2 mesecih starosti, presledek med odmerki pa je vsaj 1 mesec.
A third injection (booster) will be given in the second year of life with at least two months apart.
Tretji (obnovitveni) odmerek otrok dobi v drugem letu življenja in s presledkom vsaj 2 meseca.
1 vial 1 dose (0.5 ml)
1 viala 1 odmerek (0,5 ml)
2 ml of suspension in a vial (type I glass) for 4 doses with a stopper (butyl rubber).
2 ml suspenzije v viali (iz stekla tipa I) za 4 odmerke z zamaškom (iz butilne gume).
Pneumococcal polysaccharide serotype 7F1,2
Pnevmokokni polisaharid serotip 7F1,2
4 conjugated to diphtheria toxoid carrier protein
4 konjugiran na nosilno beljakovino davičnega toksoida
At the end-of-study analysis (ATP cohort), the vaccine efficacy (first episodes) against B-CAP was 18.2% (95% CI: 4.1; 30.3), against C-CAP 22.4% (95% CI: 5.7; 36.1) and against clinically suspected CAP referred for X-ray 7.3% (95% CI: 1.6; 12.6).
CAP 18,2 % (95 % IZ: 4,1; 30,3), proti C-CAP 22,4 % (95 % IZ: 5,7; 36,1) in proti klinično sumljivi CAP, napoteni na rentgensko slikanje, 7,3 % (95 % IZ: 1,6; 12,6).
• nausea, diarrhoea or feeling sick (vomiting)
• siljenje na bruhanje, driska ali bruhanje
Post-marketing experience Immune system disorders
Izkušnje v obdobju trženja Bolezni imunskega sistema zelo redki anafilaksija
A fine white deposit with a clear colourless supernatant may be observed upon storage of the pre-filled syringe.
Med shranjevanjem napolnjene injekcijske brizge se lahko pojavi drobna bela usedlina z bistrim, brezbarvnim supernatantom.
For catch-up vaccination, vaccine effectiveness was 33.2% (95% CI: 3.0; 53.4) in the 7-11 month cohort and 22.4% (95% CI: -8.7; 44.8) in the 12-18 month cohort.
do 11 mesecev in 22,4 % (95 % IZ: -8,7, 44,8) v kohorti od 12 do 18 mesecev.
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (butyl rubber).
0,5 ml suspenzije v viali (iz stekla tipa I) za 1 odmerek z zamaškom (iz butilne gume).
The HIV exposure or infection did not appear to alter the effect of Synflorix on pneumococcal carriage up to 24-27 months of age, i.e. up to 15 months following booster vaccination.
Izpostavljenost HIV ali okužba s HIV kot kaže ni spremenila učinka cepiva Synflorix na pnevmokokno nosilstvo do starosti
No increase in the incidence of AOM due to other bacterial pathogens or non-vaccine/non-vaccine related serotypes was observed in either COMPAS (based on the few cases reported) or POET trial.
niso opažali večje incidence akutnega vnetja srednjega ušesa zaradi drugih bakterijskih patogenov ali serotipov, ki jih ni v cepivu/s cepivom nepovezanih serotipov.
1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (butyl rubber).
1 ml suspenzije v viali (iz stekla tipa I) za 2 odmerka z zamaškom (iz butilne gume).
Synflorix contains sodium
Cepivo Synflorix vsebuje natrij.
Very common Drowsiness Rare
Žilne bolezni zelo redki
Very common Appetite lost
Presnovne in prehranske motnje zelo pogosti izguba apetita
50 doses (0.5 ml)
50 napolnjenih injekcijskih brizg 50 odmerkov (0,5 ml)
Pneumococcal polysaccharide serotype 141,2
Pnevmokokni polisaharid serotip 141,2
1-dose and 2-dose containers Sodium chloride Water for injections
Enoodmerni vsebnik in vsebnik z 2 odmerkoma natrijev klorid voda za injekcije
Anti-14
s 14 primeri).
Synflorix suspension for injection in pre-filled syringe Synflorix suspension for injection Synflorix suspension for injection in multidose container (2 doses) Synflorix suspension for injection in multidose container (4 doses)
Synflorix suspenzija za injiciranje v večodmernem vsebniku (2 odmerka) Synflorix suspenzija za injiciranje v večodmernem vsebniku (4 odmerki)
Higher OPA GMTs in the group boosted at 15-18 months of age were observed for most of the vaccine serotypes and serotype 19A.
Za večino serotipov v cepivu in za serotip 19A so ugotovili višje GMT OPA v skupini, ki je obnovitveni odmerek prejela v starosti od 15 do 18 mesecev, toda klinični pomen tega opažanja ni znan.
Pneumococcal polysaccharide serotype 51,2
Pnevmokokni polisaharid serotip 51,2
Very rare ( these may occur with up to 1 in 10,000 doses of the vaccine)
Zelo redki (pojavijo se lahko pri največ 1 od 10.000 odmerkov cepiva)
EU/1/09/508/008 - pack of 100
EU/1/09/508/008 - pakiranje po 100
The immune response to Synflorix for each of the vaccine serotypes and serotype 19A, as well as for protein D, did not appear to be influenced by SCD.
Kot kaže, bolezen srpastih celic ne vpliva na imunski odziv na cepivo Synflorix za kateri koli serotip v cepivu, niti za serotip 19A ali protein D.
Synflorix
Protitelo Synflorix
In a large-scale phase III, randomized, double-blind clinical trial (Clinical Otitis Media and Pneumonia Study - COMPAS) conducted in Argentina, Panama and Colombia, healthy infants aged 6 to 16 weeks received either Synflorix or hepatitis B control vaccine at 2, 4 and 6 months of age followed respectively by either Synflorix or hepatitis A control vaccine at 15 to 18 months of age.
stari od 6 do 16 tednov, pri 2, 4 in 6 mesecih starosti prejeli ali cepivo Synflorix ali kontrolno cepivo proti hepatitisu B, nato pa pri 15 do 18 mesecih starosti bodisi cepivo Synflorix bodisi kontrolno cepivo proti hepatitisu A.
EU/1/09/508/007 - pack of 10
EU/1/09/508/007 - pakiranje po 10
Vascular disorders
ntramuskularna uporaba
Pneumococcal polysaccharide serotype 41,2
Pnevmokokni polisaharid serotip 41,2
Anti-19F 1104 95.4 375 99.2
Anti-4 1106 97,1 373 100
After the booster dose the GMCs elicited by Synflorix were lower for most serotypes in common with 7-valent Prevenar.
Synflorix, nižja za večino serotipov, skupnih s 7-valentnim cepivom Prevenar.
For serotypes 6B and 23F, respectively, 65.9% and 81.4% of infants vaccinated at 2, 3 and 4 months reached the antibody threshold (i.e. 0.20 µg/ml) one month after the third dose of Synflorix versus 79.0% and 94.1% respectively, after three doses of 7-valent Prevenar.
Synflorix doseglo 65,9 % oziroma 81,4 % dojenčkov, cepljenih pri 2, 3 in 4 mesecih; po treh odmerkih 7-valentnega cepiva Prevenar je bil ta delež 79,0 % oziroma 94,1 %.
Immunogenicity data in preterm infants
Podatki o imunogenosti pri nedonošenčkih
Following booster vaccination, the most common adverse reactions were pain at the injection site and irritability, which occurred at approximately 51% and 53% respectively.
Po obnovitvenem cepljenju sta bila najpogostejša neželena učinka bolečina na mestu injiciranja in razdražljivost.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4 doses (0.5 ml/dose)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 4 odmerki (0,5 ml/odmerek)
Fever > 39 °C rectally (age < 2 years), injection site reactions like injection site induration Uncommon Injection site reactions like injection site haematoma, haemorrhage and nodule Adverse reactions additionally reported after booster vaccination of primary series and/or catch-up vaccination: Nervous system disorders
(starost < 2 leti), bolečina, pordelost, oteklost na mestu injiciranja pogosti zvišana telesna temperatura > 39 °C rektalno (starost < 2 leti), reakcije na mestu injiciranja, kot je induracija na mestu injiciranja občasni reakcije na mestu injiciranja, kot so hematom,
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Redki (pojavi se lahko pri največ 1 od 1.000 odmerkov cepiva)
NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection in multidose container (4 doses) Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Navodilo za uporabo Synflorix suspenzija za injiciranje v večodmernem vsebniku (4 odmerki) konjugirano, adsorbirano cepivo s pnevmokoknimi polisaharidi
How to store Synflorix
Kako uporabljati cepivo Synflorix
IPD due to individual serotypes(4) - 6B
Invazivna pnevmokokna bolezen zaradi posameznih serotipov(4)
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses (0.5 ml/dose)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2 odmerka (0,5 ml/odmerek)
Impact on nasopharyngeal carriage (NPC)
Vpliv na nazofaringealno nosilstvo
If your child gets any side effects, talk to your doctor or pharmacist.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
The clinical relevance of the above observations is unknown.
Klinični pomen teh ugotovitev ni znan.
Angioedema
- Meningitis
schedule schedule
POSTOPEK UPORABE
The proportion of subjects with an ELISA antibody concentration ≥ 0.20 µg/ml or an
Delež preiskovancev s koncentracijo protiteles z ELISA
Urticaria
Protitelo