natgillin/translations-raw huggingface dataset:
Two efficacy studies, COMPAS and POET (Pneumococcal Otitis Media Efficacy Trial), were conducted with pneumococcal conjugate vaccines containing protein D: Synflorix and an investigational 11-valent conjugate vaccine (which in addition contained serotype 3), respectively.
S konjugiranimi pnevmokoknimi cepivi, ki vsebujejo beljakovino D, sta bili opravljeni dve študiji učinkovitosti, COMPAS in POET (Pneumococcal Otitis Media Efficacy Trial): s cepivom Synflorix oziroma z raziskovalnim 11-valentnim konjugiranim cepivom (ki je dodatno vsebovalo serotip 3).
Clinical data suggest that prophylactic administration of paracetamol, used to reduce the rate of possible post-vaccination febrile reactions, might reduce the immune response to Synflorix.
Uporaba s profilaktičnim dajanjem antipiretikov Klinični podatki kažejo, da profilaktična uporaba paracetamola, ki se uporablja za znižanje stopnje možnih febrilnih reakcij po cepljenju, lahko zmanjša imunski odziv na cepivo Synflorix.
Serotype specific efficacy against the first AOM episode was demonstrated for serotypes 6B (86.5%, 95% CI: 54.9; 96.0), 14 (94.8%, 95% CI: 61.0; 99.3), 19F (43.3%, 95% CI: 6.3; 65.4) and 23F (70.8%, 95% CI: 20.8; 89.2).
Za serotip specifična učinkovitost proti prvi epizodi akutnega vnetja srednjega ušesa je bila dokazana za serotipe 6B (86,5 %, 95 % IZ: 54,9-96,0), 14 (94,8 %, 95 % IZ: 61,0-99,3), 19F (43,3 %, 95 % IZ: 6,3-65,4) in 23F (70,8 %, 95 % IZ: 20,8-89,2).
Pack size of 1, 10 or 100.
Velikost pakiranja 1, 10 ali 100.
• Synflorix is available in pre-filled syringes for 1 dose with or without needles in packs of 1, 10 or 50.
• Cepivo Synflorix je na voljo v napolnjenih injekcijskih brizgah z 1 odmerkom (z iglami ali brez igel) v pakiranjih po 1, 10 ali 50.
The third clinical study showed that the administration of 2 doses with a 2 month interval starting at 36-46 months of age resulted in higher ELISA antibody GMCs and OPA GMTs than those observed one month after a 3-dose primary vaccination for each vaccine serotype and the cross-reactive serotype 19A.
Tretja klinična študija je pokazala, da je uporaba 2 odmerkov v presledku 2 mesecev in z začetkom v starosti od 36 do 46 mesecev povzročila višje GMC protiteles z ELISA in GMT OPA za vsakega od serotipov v cepivu in za navzkrižno reaktivni serotip 19A, kot so bile ugotovljene en mesec po primarnem cepljenju s 3 odmerki.
Relative rate reduction % (95% CI)
Relativno zmanjšanje deleža(1) % (95 % IZ)
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Enako kot pri uporabi vseh parenteralnih cepiv mora biti tudi pri dajanju cepiva Synflorix vedno na voljo ustrezna medicinska oskrba in nadzor, če bi se pojavila anafilaktična reakcija, ki je sicer redka.
• If your child gets any side effects, talk to your doctor or pharmacist.
• Če pri vašem otroku opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals S.A.
IMETNIK DOVOLJENJA ZA PROMET GlaxoSmithKline Biologicals S.A.
What Synflorix looks like and contents of the pack
Izgled cepiva Synflorix in vsebina pakiranja
Efficacy of the 11 Pn-PD vaccine against the first occurrence of vaccine serotype AOM episode was 52.6% (95% CI: 35.0; 65.5).
Učinkovitost cepiva 11 Pn-PD proti prvemu pojavu akutnega vnetja srednjega ušesa s serotipom v cepivu je bila 52,6 % (95 % IZ: 35,0-65,5).
The protection against B-CAP before booster dose and at the time or after booster dose was 13.6% (95% CI: -11.3; 33.0) and 21.7% (95% CI: 3.4; 36.5) respectively.
Zaščita proti B-CAP pred poživitvenim odmerkom, ob ali po poživitvenem odmerku je bila 13,6 % (95% IZ: -11,3; 33,0) in 21,7 % (95% IZ: 3,4; 36,5).
Hypotonic-hyporesponsive episode
Bolezni živčevja redki hipotonično-hiporesponzivne epizode
For serotypes 1, 5 and 7F, the percentages of Synflorix vaccinees reaching an OPA titre ≥ 8 were respectively 65.7%, 90.9% and 99.6% after the primary vaccination course and 91.0%, 96.3% and 100% after the booster dose.
Po primarnem ciklusu cepljenja s cepivom Synflorix je titre OPA ≥ 8 proti serotipom 1, 5 in 7F doseglo 65,7 %, 90,9 % in 99,6 % cepljenih, po obnovitvenem odmerku pa 91,0 %, 96,3 % in 100 %.
Immunogenicity of Synflorix in very preterm (gestation period of 27-30 weeks) (N=42), preterm (gestation period of 31-36 weeks) (N=82) and full term (gestation period > 36 weeks) (N=132) infants was evaluated following a 3-dose primary vaccination course at 2, 4, 6 months of age.
Imunogenost cepiva Synflorix pri zelo nedonošenih (gestacijska starost od 27 do 30 tednov) (n = 42), nedonošenih (gestacijska starost od 31 do 36 tednov) (n = 82) in donošenih (gestacijska starost
No. of IPD cases
Število primerov IPB
Overall, the pre-booster persistence of immune responses was lower in the 2-dose compared to the 3-dose priming group for most vaccine serotypes and was similar for serotype 19A.
V celoti je bilo trajanje imunskih odzivov pred obnovitvenim odmerkom v skupini, primarno cepljeni z 2 odmerkoma, manjše kot v skupini, primarno cepljeni s 3 odmerki, za večino serotipov v cepivu, za serotip 19A pa je bila podobna.
Synflorix can be given at the same time as other childhood vaccines such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B, measles-mumps-rubella, varicella, oral rotavirus vaccines as well as meningococcal serogroup C and serogroups A, C, W-135, Y conjugate vaccines.
Cepivo Synflorix je mogoče uporabiti hkrati z drugimi otroškimi cepivi, npr. proti davici, tetanusu in oslovskemu kašlju, Haemophilusu influenzae tipa b, peroralnim ali inaktiviranim cepivom proti otroški paralizi (poliu), hepatitisu B, ošpicam, mumpsu in rdečkam, noricam, peroralnim cepivom proti rotavirusom ter s konjugiranimi cepivi proti meningokokom serološke skupine C in seroloških skupin A, C, W-135 in Y. Vsako cepivo bodo otroku vbrizgali na drugo mesto.
Children from 6 weeks up to 5 years of age considered to be at a higher risk of pneumococcal infection (such as those with HIV infection, sickle cell disease or impaired or abnormal functioning of the spleen) may receive Synflorix.
Otroci, stari od 6 tednov do 5 let, ki so bolj izpostavljeni pnevmokoknim okužbam (npr. otroci, okuženi s HIV, z boleznijo srpastih celic ali okvarjenim ali nenormalnim delovanjem vranice), lahko dobijo cepivo Synflorix.
Overall, the persistence of the immune response until the booster at 11 months of age was lower in the 2-dose primed subjects.
V celoti je bilo trajanje imunskega odziva do obnovitvenega odmerka pri 11 mesecih starosti nižje med preiskovanci, ki so primarno dobili 2 odmerka.
Similar antibody GMCs and OPA GMTs were observed for all infants except a lower OPA GMT for serotype 5 in very preterm infants.
GMC protiteles in GMT OPA so ugotovili pri vseh dojenčkih, razen manjšega GMT OPA za serotip 5
If you are not sure, talk to your doctor or pharmacist before having Synflorix.
Če niste prepričani, se pred uporabo cepiva Synflorix posvetujte z zdravnikom ali farmacevtom.
• diffuse swelling of the injected limb, sometimes involving the adjacent joint
• kožni izpuščaj • difuzna oteklost uda v katerega je bilo injicirano cepivo, ki včasih zajame tudi sosednji sklep
A booster (third) dose is recommended at least 6 months after the last primary dose and may be given from the age of 9 months onwards (preferably between 12 and 15 months of age) (see section 5.1).
Obnovitveni (tretji) odmerek je priporočljivo dati vsaj 6 mesecev po zadnjem odmerku primarnega cepljenja in se ga lahko da od 9. meseca starosti dalje (po možnosti med 12. in 15. mesecem starosti) (glejte poglavje 5.1).
For the cross-reactive serotype 19A, similar percentages of subjects reaching antibody threshold and OPA titres ≥ 8 and similar antibody GMC and OPA GMT were observed post-primary in both groups.
Za navzkrižno reaktivni serotip 19A je po primarnem cepljenju podoben delež otrok v obeh skupinah dosegel prag protiteles in titre OPA ≥ 8 ter GMC protiteles in GMT OPA.
Efficacy against any AOM episode due to any pneumococcal serotype was 51.5% (95% CI: 36.8; 62.9).
Učinkovitost proti katerikoli epizodi akutnega vnetja srednjega ušesa zaradi kateregakoli pnevmokoknega serotipa je bila 51,5 % (95 % IZ: 36,8-62,9).
OPA titre ≥ 8 for each vaccine serotype was comparable or higher in the catch-up group than in the 3dose primed infants.
≥ 0,20 µg/ml ali titrom OPA ≥ 8 za vsakega od serotipov v cepivu je bil v skupini z naknadnim cepljenjem primerljiv ali večji kot med dojenčki, primarno cepljenimi s 3 odmerki.
Multidose vial 2-dose vial EU/1/09/508/009 4-dose vial EU/1/09/508/012 EU/1/09/508/013
Viala z 2 odmerkoma EU/1/09/508/009 Viala s 4 odmerki EU/1/09/508/012 EU/1/09/508/013
Post-primary antibody geometric mean concentrations (GMCs) elicited by Synflorix against the seven serotypes in common were lower than those elicited by 7-valent Prevenar.
Postprimarna geometrijska sredina koncentracij (GMC - geometric mean concentrations) protiteles, ki jih je proti sedmim skupnim serotipom izzvalo cepivo Synflorix, je bila nižja, kot po 7-valentnem cepivu Prevenar.
Uncommon Diarrhoea, vomiting
Bolezni prebavil občasni diarea, bruhanje
No data are available on subcutaneous administration of Synflorix.
Podatkov o subkutani uporabi cepiva Synflorix ni.
For the cross-reactive serotype 19A, similar ELISA antibody GMCs were observed post-primary and post-booster for the 2-dose schedule [0.14 µg/ml (95% CI: 0.12; 0.17) and 0.73 µg/ml (95% CI: 0.58; 0.92)] and the 3-dose schedule [0.19 µg/ml (95% CI: 0.16; 0.24) and 0.87 µg/ml (95% CI: 0.69; 1.11)].
Za navzkrižno reaktivni serotip 19A so opažali podobno geometrično sredino koncentracije protiteles z ELISA po primarnem cepljenju in po obnovitvenem odmerku za shemo z 2 odmerkoma (0,14 µg/ml (95 % IZ: 0,12, 0,17) in 0,73 µg/ml (95 % IZ: 0,58, 0,92)) ter shemo s 3 odmerki (0,19 µg/ml (95 % IZ: 0,16, 0,24) in 0,87 µg/ml (95 % IZ: 0,69, 1,11)).
The booster dose of Synflorix in HIV+/+ and HIV+/- infants induced robust increases in ELISA antibody GMCs and OPA GMTs for each vaccine serotype and serotype 19A indicative of immunological priming.
Obnovitveni odmerek cepiva Synflorix je pri HIV+/+ in HIV+/- dojenčkih povzročil močno povečanje geometrične sredine koncentracij protiteles z ELISA in geometrične sredine titrov OPA za vse serotipe v cepivu in za serotip 19A; to kaže na doseženo imunološko pripravo (priming).
Store in the original package in order to protect from light.
Shranjujte v originalnem pakiranju za zagotovitev zaščite pred svetlobo.
Common (these may occur with up to 1 in 10 doses of the vaccine) • hardness where the injection is given
Pogosti (pojavi se lahko pri največ 1 od 10 odmerkov cepiva) • zatrdelost na mestu, kamor je bilo vbrizgano cepivo
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF PRE-FILLED SYRINGE WITH OR WITHOUT NEEDLE, PACK OF 1, 10, 50
ŠKATLA Z NAPOLNJENO INJEKCIJSKO BRIZGO Z IGLO ALI BREZ NJE, PAKIRANJA PO 1, 10, 50
For the cross-reactive serotype 19A, the results did not suggest any differences in ELISA antibody GMCs and OPA GMTs between groups.
Za navzkrižno reaktivni serotip 19A rezultati niso pokazali nobene razlike v geometrični sredini koncentracij protiteles z ELISA ali geometrične sredine titrov OPA med skupinami.
• Each injection will be given at least one month apart except for the last injection (booster),
• Med injekcijami cepiva mora miniti vsaj en mesec, razen pri zadnji injekciji (obnovitveni odmerek), ki bo uporabljena vsaj 6 mesecev po tretji injekciji.
0.5 ml of suspension in a pre-filled syringe (type I glass) for 1 dose with a plunger stopper (butyl rubber) with or without needles.
0,5 ml suspenzije v napolnjeni injekcijski brizgi (iz stekla tipa I) za 1 odmerek z batnim zamaškom (iz butilne gume), z iglami ali brez njih.
As with any vaccine, Synflorix may not protect all vaccinated individuals against invasive pneumococcal disease, pneumonia or otitis media caused by the serotypes in the vaccine and the cross-reactive serotype 19A.
Tako kot velja za vsa cepiva, je mogoče tudi, da cepivo Synflorix proti invazivni pnevmokokni bolezni, pljučnici ali vnetju srednjega ušesa, ki jih povzročajo serotipi v cepivu in navzkrižno reaktivni serotip 19A, ne zaščiti vseh cepljenih oseb.
(3) Culture or PCR confirmed cases for serotypes 4, 6B, 7F, 9V, 14, 18C, 19F and 23F contributed to the analysis.
(3) K analizi so prispevali s kulturo ali PCR potrjeni primeri serotipov 4, 6B, 7F, 9V, 14, 18C, 19F in 23F.
In a large-scale phase III/IV, double-blind, cluster-randomized, controlled, clinical trial in Finland (FinIP), children were randomised into 4 groups according to the two infant vaccination schedules [2-dose (3, 5 months of age) or 3-dose (3, 4, 5 months of age) primary schedule followed by a booster dose as of 11 months of age] to receive either Synflorix (2/3rd of clusters) or hepatitis vaccines as control (1/3rd of clusters).
faze na Finskem (FinIP), so otroke randomizirali v 4 skupine glede na dve shemi cepljenja [shema primarnega cepljenja z 2 odmerkoma (3. in 5. mesec starosti) ali s 3 odmerki (3., 4. in 5. mesec starosti) in nato obnovitveni odmerek od 11. meseca starosti]; preiskovanci so dobili ali cepivo Synflorix (2/3 klastrov) ali cepivo proti hepatitisu kot kontrolno cepivo (1/3 klastrov).
• Suspension for injection in multidose container (4 doses)
• Suspenzija za injiciranje v večodmernem vsebniku (4 odmerki)
Synflorix should not be given if any of the above applies to your child.
Vaš otrok ne sme dobiti cepiva Synflorix, če zanj velja karkoli od navedenega.
• Suspension for injection in multidose container (2 doses)
• Suspenzija za injiciranje v večodmernem vsebniku (2 odmerka)
(2) Culture confirmed cases for serotypes 1, 4, 6B, 7F, 9V, 14, 18C, 19F and 23F contributed to the analysis.
(2) K analizi so prispevali s kulturo potrjeni primeri serotipov 1, 4, 6B, 7F, 9V, 14, 18C, 19F in 23F.
In the interim analysis (ATP cohort), the vaccine efficacy against first episodes of CAP with alveolar consolidation or pleural effusion (C-CAP, WHO definition) was 25.7% (95% CI: 8.4; 39.6) and against first episodes of clinically suspected CAP referred for X-ray was 6.7% (95% CI: 0.7; 12.3).
Vmesna analiza (kohorta po protokolu) je pokazala, da je učinkovitost cepiva proti prvi epizodi CAP z alveolarno konsolidacijo ali plevralnim izlivom (C-CAP, definicija Svetovne zdravstvene organizacije) 25,7 % (95 % IZ: 8,4; 39,6) in proti prvi epizodi klinično sumljivi CAP, napoteni na rentgensko slikanje, 6,7 % (95 % IZ: 0,7; 12,3).
A booster (fourth) dose is recommended at least 6 months after the last primary dose and may be given from the age of 9 months onwards (preferably between 12 and 15 months of age) (see sections 4.4 and 5.1).
Obnovitveni (četrti) odmerek je priporočljivo dati vsaj 6 mesecev po zadnjem odmerku primarnega cepljenja in se ga lahko da od 9. meseca starosti dalje (po možnosti med 12. in 15. mesecem starosti) (glejte poglavji 4.4 in 5.1).
The vaccine efficacy against the first episode of NTHi AOM was 31.1% (95% CI: -3.7; 54.2, not significant).
Učinkovitost cepiva proti prvemu pojavu akutnega vnetja srednjega ušesa z NTHi je bila 31,1 % (95 % IZ: -3,7; 54,2, ni značilno).
Pneumococcal polysaccharide serotype 18C1,3
Pnevmokokni polisaharid serotip 18C1,3
Fever ≥ 38 °C rectally (age 2 to 5 years) Uncommon Fever > 40 °C rectally (age < 2 years), fever > 39 °C rectally (age 2 to 5 years), injection site reactions like diffuse swelling of the injected limb, sometimes involving the adjacent joint, pruritus.
občasni zvišana telesna temperatura > 40 °C rektalno (starost < 2 leti), zvišana telesna temperatura > 39 °C rektalno (starost od 2 do 5 let), reakcije na mestu injiciranja, kot je difuzna oteklost uda v katerega je bilo injicirano cepivo, ki včasih zajame tudi sosednji sklep, srbenje
There are no data available to indicate whether the administration of pneumococcal polysaccharide vaccine to Synflorix primed children may result in hyporesponsiveness to further doses of pneumococcal polysaccharide or to pneumococcal conjugate vaccine.
Ni podatkov, ali lahko pnevmokokno polisaharidno cepivo zmanjša odzivnost na nadaljnje odmerke pnevmokoknega polisaharidnega ali pnevmokoknega konjugiranega cepiva pri otrocih, ki so že dobili cepivo Synflorix.
A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial.
Med shranjevanjem viale se lahko pojavi drobna bela usedlina z bistrim, brezbarvnim supernatantom.
• The other ingredients are sodium chloride (see section 2 for further information) and water for injections
• Pomožni snovi sta natrijev klorid (glejte poglavje 2 za dodatne informacije) in voda za injekcije.
• Suspension for injection in pre-filled syringe
• Suspenzija za injiciranje v napolnjeni injekcijski brizgi.
- children aged 12 months -5 years: The vaccination schedule consists of two doses of 0.5 ml with an interval of at least 2 months between doses.
- Otroci, stari od 12 mesecev do 5 let: Shema cepljenja mora obsegati 2 odmerka po 0,5 ml z vsaj
Before and after NIP comparison suggests a significant decrease in the incidence of any culture confirmed IPD, any vaccine serotype IPD and IPD due to serotype 19A.
Primerjava pred in po NPC kaže značilno zmanjšanje incidence katere koli s kulturo potrjene invazivne pnevmokokne bolezni, invazivne pnevmokokne bolezni zaradi katerega koli serotipa v cepivu in invazivne pnevmokokne bolezni zaradi serotipa 19A.
Efficacy was 100% (95% CI: 41.9; 100) against bacteraemic pneumococcal pneumonia or empyema due to vaccine serotypes.
IZ: 41,9; 100) proti bakteriemični pljučnici, povzročeni s pnevmokoki, ali empiemu, povzročenim s serotipi, prisotnimi v cepivu.
MARKETING AUTHORISATION NUMBER(S) EU//1/09/508/009
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/09/508/009
In a clinical study NPC was assessed in HIV positive infants (N = 83) and HIV negative infants born from HIV positive mothers (N = 101) and compared to HIV negative infants born from HIV negative mothers (N = 100).
HIV-negativnih dojenčkih, rojenih HIV-pozitivnim materam (N = 101), v primerjavi z nosilstvom pri HIV-negativnih dojenčkih, rojenih HIV-negativnim materam (N = 100).
Efficacy against any NTHi AOM episode was 35.3% (95% CI: 1.8; 57.4).
Učinkovitost proti kateremu koli pojavu akutnega vnetja srednjega ušesa z NTHi je bila 35,3 % (95 % IZ: 1,8, 57,4).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL MULTIDOSE (4 DOSES), PACK OF 10, 100
PODATKI NA ZUNANJI OVOJNINI VEČODMERNA VIALA (4 ODMERKI), PAKIRANJE PO 10, 100
Each injection will be given at least two months apart.
Med injekcijama cepiva morata miniti vsaj dva meseca.
• The other ingredients are: sodium chloride (see section 2 for further information), 2-phenoxyethanol and water for injections
• Pomožni snovi so: natrijev klorid (glejte poglavje 2 za dodatne informacije), 2-fenoksietanol in voda za injekcije.
3 conjugated to tetanus toxoid carrier protein
3 konjugiran na nosilno beljakovino tetanusnega toksoida
Uncommon Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Bolezni dihal, prsnega koša in mediastinalnega prostora občasni apneja pri zelo nedonošenih otrocih (≤ 28 tednov nosečnosti) (glejte poglavje 4.4)
Any pneumococcal serotype
Kateri koli serotip pnevmokokov
4-dose vial
Viala s 4 odmerki
Efficacy of Synflorix against first episodes of likely bacterial Community Acquired Pneumonia (CAP) occurring from 2 weeks after the administration of the 3rd dose was demonstrated in the ATP cohort
Učinkovitost cepiva Synflorix proti prvi epizodi verjetno bakterijsko povzročene pljučnice, dobljene v domačem okolju (CAP - community acquired pneumonia), ki se je pojavila od drugega tedna po prejetju tretjega odmerka, je bila dokazana v kohorti po protokolu (vrednost p ≤ 0,002) pri vmesni analizi (pogojen z dogodkom, primarni cilj).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Synflorix injection
IME ZDRAVILA IN POT(I) UPORABE Synflorix injekcija i.m.
Ask your pharmacist how to throw away medicines you no longer use.
O načinu odstranjevanja cepiva, ki ga ne potrebujete več, se posvetujte s farmacevtom.
LIST OF EXCIPIENTS Sodium chloride Water for injections
SEZNAM POMOŽNIH SNOVI natrijev klorid, voda za injekcije
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Synflorix suspension for injection
IME ZDRAVILA IN POT(I) UPORABE Synflorix suspenzija za injiciranje i.m.
• The other ingredients are: sodium chloride (see section 2 for further information) and water for injections
• Pomožni snovi sta: natrijev klorid (glejte poglavje 2 za dodatne informacije) in voda za injekcije.
Post-primary and post-booster OPA antibody geometric mean titres (GMTs) elicited by Synflorix were lower than those elicited by 7-valent Prevenar for the seven shared serotypes, except for serotype 19F.
Postprimarna in poobnovitvena geometrijska sredina titrov (GMT - geometric mean titres) protiteles OPA, ki jih je proti sedmim skupnim serotipom izzvalo cepivo Synflorix, je bila - z izjemo serotipa 19F - nižja kot s 7-valentnim cepivom Prevenar.
In both schedules, a booster response indicative of immunological priming was observed.
Pri obeh shemah so opazili odziv na obnovitveni odmerek, ki kaže na imunološko pripravo.
Synflorix should under no circumstances be administered intravascularly or intradermally.
Cepiva Synflorix nikdar ne smete injicirati intravaskularno ali intradermalno.
VE (95% CI)
% (95 % IZ)
Pack size of 100.
Velikost pakiranja 100.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL MULTIDOSE (2 DOSES), PACK OF 100
PODATKI NA ZUNANJI OVOJNINI VEČODMERNA VIALA (2 ODMERKA), PAKIRANJE S 100
2-dose vial
Viala z 2 odmerkoma
These results are indicative of immunological memory in primed subjects for all vaccine serotypes and the cross-reactive serotype 19A.
Ti rezultati kažejo imunološki spomin za vse serotipe v cepivu in za navzkrižno reaktivni serotip 19A pri preiskovancih, ki so dobili primarno cepljenje.
cohort, vaccine efficacy against first clinical AOM episode was 19% (95% CI: 4.4; 31.4).
Toda v kohorti TVC je bila učinkovitost cepiva proti prvemu pojavu kliničnega akutnega vnetja srednjega ušesa 19 % (95 % IZ: 4,4, 31,4).
92.7% of subjects achieved ELISA antibody concentrations ≥ 0.20 µg/ml and at least 81.7% achieved OPA titres ≥ 8 except serotype 1 (at least 58.8% with OPA titres ≥ 8).
En mesec po primarnem cepljenju (tj. po tretjem odmerku) je vsaj 92,7 % preiskovancev doseglo koncentracijo protiteles z ELISA ≥ 0,20 µg/ml in vsaj 81,7 % je doseglo titre OPA ≥ 8 za vse serotipe v cepivu, razen za serotip 1 (vsaj 58,8 % s titri OPA ≥ 8).
After a single dose of Synflorix, administered during the 4th year of life, as a challenge dose, the fold increase in ELISA antibody GMCs and OPA GMTs, pre to post vaccination, was similar in 2-dose primed subjects to that in 3-dose primed subjects.
Po enkratnem odmerku cepiva Synflorix, uporabljenem v 4. letu življenja kot provokacijski odmerek, je bil večkratnik povečanja geometrične sredine koncentracije protiteles z ELISA in geometrične sredine titra OPA pred in po cepljenju med preiskovanci, ki so primarno dobili 2 odmerka, podoben kot med tistimi, ki so primarno dobili 3 odmerke.
• In children aged 12-23 months, the immune responses elicited after two doses were comparable to the responses elicited after three doses in infants below 6 months of age, except for vaccine serotypes 18C and 19F as well as serotype 19A for which responses were higher in the 12-23 months children.
primerljiv odzivu doseženem po treh odmerkih pri dojenčkih, mlajših od 6 mesecev, razen za serotipa v cepivu 18C in 19F in serotip 19A, za katere so bili odzivi večji pri otrocih v starosti od 12 do 23 mesecev.
How Synflorix works
Kako cepivo Synflorix deluje