natgillin/translations-raw huggingface dataset:
The vaccine works by helping the body to make its own antibodies, which protect your child against
Cepivo deluje tako, da pomaga telesu tvoriti lastna protitelesa, ki ščitijo vašega otroka pred naštetimi
Prevenar is not intended for use in adults.
Cepivo Prevenar ni namenjeno za uporabo pri odraslih.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem
Upon storage, a white deposit and clear supernatant can be observed.
Med shranjevanjem lahko nastane bela usedlina in bister supernatant.
Antipyretic treatment should be initiated according to local treatment guidelines.
Antipiretično zdravljenje naj se izvaja v skladu z lokalnimi smernicami.
Unvaccinated infants and children over 7 months of age
Necepljeni dojenčki in otroci, starejši od 7 mesecev
Efficacy against pneumonia
Učinkovitost proti pljučnici
According to official recommendations in your country, an alternative schedule may be used by your health-care provider.
V skladu z uradnimi priporočili v vaši državi lahko vaš zdravstveni delavec uporabi kakšno drugačno shemo cepljenja.
Children were followed until 3.5 years of age.
Otroke so spremljali, dokler niso bili stari 3,5 leta.
For the number of doses to be administered in the different age groups, see section 4.2.
Glede števila odmerkov, ki so potrebni v različnih starostnih skupinah, glejte poglavje 4.2.
• You will be told when your child should come back for the next injection
• Povedali vam bodo, kdaj mora otrok prejeti naslednji odmerek.
The marketing authorisation holder must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bo sistem farmakovigilance, predstavljen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in bo deloval, preden bo dal zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
These reactions were mostly moderate (less than or equal to 39 °C) and transient (see section 4.8).
Te reakcije so večinoma zmerne (39 °C ali manj) in prehodne (glejte poglavje 4.8).
Previously unvaccinated older infants and children:
Predhodno necepljeni starejši dojenčki in mali otroci:
The frequency is defined as follows: Very common(  1/10) Common ( 1/100 to < 1/10) Uncommon ( 1/1,000 to < 1/100) Rare ( 1/10,000 to < 1/1,000)
Pogostnost je opredeljena takole: zelo pogosti ( 1/10) pogosti ( 1/100 in < 1/10) občasni ( 1/1.000 in < 1/100) redki ( 1/10.000 in < 1/1.000) zelo redki (< 1/10.000)
Official batch release: in accordance with Article 114 of Council Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Uradna sprostitev serije: v skladu s 114. členom dopolnjene in spremenjene Direktive 2001/83/ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
Pharmacotherapeutic group: pneumococcal vaccines, ATC code: J07AL02
Farmakoterapevtska skupina: cepiva proti pnevmokoknim infekcijam, oznaka ATC: J07AL02
The safety of the vaccine was assessed in different controlled clinical studies in which more than 18,000 healthy infants (6 weeks to 18 months) were included.
Podatki o varnosti cepiva izhajajo iz različnih kontroliranih kliničnih študij, v katere je bilo vključenih več kot 18.000 zdravih otrok (starih 6 tednov do 18 mesecev).
* Conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg)
* vezan na CRM197 nosilni protein in adsorbiran na aluminijev fosfat (0,5 mg)
A subset of children in this study were followed until they reached 4 to 5 years of age.
Podskupino otrok v tej študiji so spremljali do njihovega 4. ali 5. leta starosti.
The majority of the safety experience comes from the efficacy trial in which 17,066 infants received 55,352 doses of Prevenar.
Večino podatkov o varnosti so dobili v študijah o učinkovitosti, v katere je bilo vključenih 17.066 otrok, ki so prejeli skupno 55.352 odmerkov cepiva Prevenar.
Antipyretic treatment should be initiated whenever warranted or when the temperature rises above 39°C.
Antipiretično zdravljenje pričnemo, kadar je upravičeno ali kadar je telesna temperatura višja od 39 °C.
• Erythema multiforme (a rash causing itchy red blotches)
• multiformni eritem (izpuščaj, ki povzroča srbeče rdeče lise)
CRM197, Activated Saccharides, and Conjugates Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 4300 Oak Park
CRM197, aktivirani saharidi in konjugati Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 4300 Oak Park
The expiry date refers to the last
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Due to the long-standing post marketing experience, the well characterised safety profile and the large exposure of the product the PRAC recommended to amend the PSUR frequency to 10-yearly and to amend Annex II accordingly to reflect the current QRD template sentence referring to the EURD list.
Odbor PRAC zaradi dolgotrajnih izkušenj iz obdobja trženja zdravila, dobro znanega varnostnega profila in velike izpostavljenosti zdravilu priporoča spremembo pogostnosti PSUR na 10 let in ustrezno spremembo Priloge II, da bo odražala stavek iz trenutne predloge QRD, ki se nanaša na seznam EURD.
- if your child is allergic (hypersensitive) to the active substances, to any other ingredients or to
- če je vaš otrok alergičen (preobčutljiv) na zdravilne učinkovine, na katerokoli drugo sestavino
No undesirable effects were reported in the majority of individuals.
V večini primerov niso poročali o neželenih učinkih.
Acute otitis media (AOM) is a common childhood disease with different aetiologies.
Akutno vnetje srednjega ušesa (AOM - acute otitis media) je pogosta otroška bolezen z različnimi etiologijami.
Please tell your doctor, nurse or pharmacist if your child is taking or has recently taken any other medicines including medicines obtained without prescription or has recently received any other vaccine.
Prosimo, povejte zdravniku, sestri ali farmacevtu, če vaš otrok jemlje ali je pred kratkim jemal katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta, ali če je bil pred kratkim cepljen.
Medicines should not be disposed of via wastewater or household waste.
Cepiva ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Efficacy against invasive disease was assessed in a large-scale randomised, double-blind, clinical trial in a multiethnic population in Northern California (Kaiser Permanente trial).
Učinkovitost proti invazivni bolezni je bila ugotovljena v veliki, randomizirani, dvojno slepi klinični študiji med večetničnim prebivalstvom v Severni Kaliforniji (študija Kaiser Permanente).
• A fourth injection (booster) will be given between 11 and 15 months of age
• Četrti (obnovitveni) odmerek bo prejel v starosti od 11 do 15 mesecev.
In older children receiving a single dose of vaccine, a higher rate of local reactions has been observed than that previously described in infancy.
Pri starejših otrocih, ki so dobili en sam odmerek cepiva, je bila pogostnost lokalnih reakcij večja, kot je bila predhodno opisana pri dojenčkih.
• Hypotonic-hyporesponsive episode (collapse or shock-like state)
• epizoda hipotonije in zmanjšane odzivnosti (kolaps ali šoku podobno stanje)
In Quebec, Canada Prevenar was introduced at 2, 4 and 12 months of age with a single dose catch-up programme in children up to 5 years of age.
V Quebecu v Kanadi so Prevenar uvedli v starosti 2, 4 in 12 mesecev s programom naknadnega cepljenja z enkratnim odmerkom otrok, starih do 5 let.
Preliminary data from England and Wales reported less than 1 year following introduction of routine immunisation at 2, 4 and 13 months with a single dose catch-up programme for children 13 to 23 months of age have suggested that effectiveness of this schedule might be lower against serotype 6B than against
Predhodni podatki iz Anglije in Walesa, o katerih so poročali manj kot 1 leto po uvedbi rutinskega cepljenja pri 2, 4 in 13 mesecih z naknadnim programom z enim samim odmerkom pri otrocih, starih 13 do 23 mesecev, so pokazali, da utegne biti učinkovitost te sheme manjša proti serotipu 6B kot proti
Detailed information on this medicine is available on the European Medicines Agency website:
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila:
WHAT PREVENAR IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO PREVENAR IN ZA KAJ GA UPORABLJAMO
Also safety in previously unvaccinated older children has been assessed.
Ocenjeni so bili tudi podatki o varnosti pri starejših otrocih, ki niso bili
The pneumococcus is responsible for 30-40% of all bacterial AOM and a greater fraction of severe AOM.
Pnevmokoki so odgovorni za 30 % - 40 % vseh primerov bakterijskega AOM in za še večji delež težkega AOM.
Also contains sodium chloride and water for injections.
Vsebuje tudi natrijev klorid in vodo za injekcije.
The decrease in the incidence of IPD seen in older children may be partly due to naturally acquired immunity.
Zmanjšanje incidence invazivne pnevmokokne bolezni pri starejših otrocih je morda delno posledica naravno pridobljene imunosti.
Infants aged 6 weeks to 6 months of age
Dojenčki, stari od 6 tednov do 6 mesecev
The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine into your child's arm or leg muscle.
Zdravnik ali sestra bo otroku injiciral priporočeni odmerek cepiva (0,5 ml) v mišico na roki ali nogi.
Official Medicines Control Laboratory (OMCL) Agence Française de Sécurité Sanitaire des Produits de Santé Direction des laboratoires et des contrôles Avenue Jean Jaurès, 321
Uradni kontrolni laboratorij za zdravila (Official Medicines Control Laboratory - OMCL) Agence Française de Sécurité Sanitaire des Produits de Santé Direction des laboratoires et des contrôles
Vaccine effectiveness against IPD caused by vaccine serotypes was evaluated in 3- to 59-month old children within the first four years of the implementation of the programme.
Učinkovitost cepiva proti IPD, povzročenim s serotipi, vključenimi v cepivo, so ovrednotili pri otrocih, starih od 3 mesece do 59 mesecev, v prvih štirih letih izvajanja programa.
It is estimated that more than 80 % of the antimicrobial resistant strains would be covered by the serotypes included in the vaccine.
Ocenjujejo, naj bi bilo več kot 80 % na antibiotike odpornih sevov pokritih s serotipi, ki so vključeni v cepivo.
Theoretically, Prevenar could prevent about 6080% of serotypes causing pneumococcal AOM.
Teoretično bi Prevenar lahko preprečil okrog 60 % - 80 % serotipov, ki povzročajo pnevmokokno AOM.
In all studies, Prevenar was administered concurrently with the recommended childhood vaccines.
V vseh študijah so uporabljali cepivo Prevenar skupaj s priporočenimi cepivi za otroke.
At the booster, some suppression of Hib antibody level was observed but all children had protective levels.
Po poživitvenem odmerku so opazili nekoliko zmanjšan titer protiteles proti bakteriji Hib, vendar so imeli vsi otroci potrebno zaščitno raven protiteles.
Antibody concentrations were similar to those achieved following a three-dose infant series and a booster dose at less than 2 years of age.
Koncentracije protiteles so bile podobne tistim, ki so jih dosegli po zaporedju treh odmerkov za dojenčke in poživitvenem odmerku pri otrocih, mlajših od 2 let.
At the time of the study, the serotypes included in the vaccine accounted for 89 % of IPD.
V času študije so serotipi v cepivu vključevali 89 % povzročiteljev IPD.
Human data on the use during pregnancy or lactation and animal reproduction studies are not available.
Podatki o uporabi med nosečnostjo ali dojenjem pri človeku in podatki iz študije vplivov na sposobnost razmnoževanja pri živalih niso na
It will not protect against other infectious agents that can cause
Ne zaščiti pa pred drugimi povzročitelji okužb, ki
A minor infection, such as a cold, should not be a problem.
Vendar pa blažja okužba, kot je prehlad, ni razlog za odložitev
Estimates of efficacy against invasive disease were obtained in the US population where vaccine serotype coverage ranged from 80 to 89 %.
Oceno o učinkovitosti proti invazivnim okužbam so dobili med ameriškim prebivalstvom, kjer v cepivo vključeni serotipi tvorijo od 80 % do 89 % vseh primerov okužb.
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 po 28 tednih gestacije ali prej) se lahko pojavijo daljši premori med vdihi dva do tri dni po cepljenju.
What Prevenar looks like and contents of the pack
Izgled cepiva Prevenar in vsebina pakiranja
The immunogenicity of Prevenar has been investigated in an open-label, multicenter study in 49 infants with sickle cell disease.
Imunogenost cepiva Prevenar so raziskali v odprti multicentrični študiji pri 49 dojenčkih z anemijo srpastih celic.
Additionally, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease.
Poleg tega je za serotipe, zastopane v cepivu, pričakovati, da bo zaščita pred vnetjem srednjega ušesa znatno manjša kot zaščita pred invazivnimi boleznimi.
Detailed information on this product is available on the website of the European Medicines Agency
Podrobne informacije o cepivu so objavljene na spletni strani Evropske agencije za zdravila
In the USA, generalised vaccination with Prevenar using a four-dose series in infants and a catch-up programme for children up to 5 years of age was introduced in 2000.
V ZDA so splošno cepljenje s cepivom Prevenar, in sicer zaporedje štirih odmerkov pri dojenčkih in program naknadnega cepljenja za otroke, stare do 5 let, uvedli leta 2000.
The immunogenicity of a two-dose primary series in infants plus a booster at about one year of age has been documented in several studies.
Imunogenost primarnega zaporedja dveh odmerkov pri dojenčkih in poživitvenega odmerka približno v starosti enega leta so dokumentirali v več študijah.
Prevenar will only protect against ear infections caused by the types of Streptococcus pneumoniae for which the vaccine has been developed.
Prevenar ščiti samo pred okužbami ušesa, ki jih povzročajo tisti tipi bakterije Streptococcus pneumoniae, proti katerim so to cepivo razvili.
The need for a booster dose after these immunisation schedules has not been established.
Ali je po teh imunizacijskih shemah potreben poživitveni odmerek, ni bilo ugotovljeno.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Inconsistent reduction in response to pertussis antigens as well as to inactivated polio vaccine (IPV) were observed.
Včasih so opazili tudi zmanjšan imunski odgovor na antigene oslovskega kašlja in na inaktivirano polio vakcino (IPV).
For any information about this medicinal product, please contact the local representative of the Marketing
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika
Infants aged 2 - 6 months:
Dojenčki od 2. do 6. meseca starosti:
Each 0.5 ml dose contains 2 micrograms of saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 micrograms of serotype 6B per dose (16 micrograms total saccharide) conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg).
En odmerek po 0,5 ml vsebuje po 2 mikrograma saharidov serotipov 4, 9V, 14, 18C, 19F in 23F in 4 mikrograme serotipa 6B (vseh saharidov je 16 mikrogramov), konjugiranih na CRM197 nosilni protein in adsorbiranih na aluminijev fosfat (0,5 mg).
The preferred sites are anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in young children.
Najprimernejše mesto injiciranja je anterolateralni del stegna (mišica vastus lateralis) pri dojenčkih ali deltoidna mišica na nadlahti pri majhnih otrocih.
Children below 2 years old should receive the appropriate-for-age Prevenar vaccination series (see section 4.2).
Pri otrocih, mlajših od 2 let, je treba uporabiti starosti primerno zaporedje cepljenj s cepivom Prevenar (glejte poglavje 4.2).
Fever of > 39 °C was reported in 3.3 % of children compared to 1.2 % in the control group.
O zvišani telesni temperaturi  39 °C so poročali pri 3,3 % otrok v primerjavi z 1,2 % otrok iz kontrolne skupine.
Do not use Prevenar after the expiry date stated on the carton and label.
Cepiva Prevenar ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Vaccination in high-risk groups should be considered on an individual basis.
Glede cepljenja otrok z visokim tveganjem se je potrebno odločiti za vsakega posameznika posebej.
In European children between 2 to 5 years of age, Prevenar should cover about 62 % to 83 % of the clinical isolates responsible for invasive pneumococcal disease.
Pri evropskih otrocih, starih od 2 do 5 let, naj bi cepivo Prevenar pokrilo okrog 62 % do 83 % klinično izoliranih pnevmokokov, ki povzročajo invazivne pnevmokokne bolezni.
Children were vaccinated with Prevenar (3 doses one month apart from the age of 2 months) and 46 of these children also received a 23-valent pneumococcal polysaccharide vaccine at the age of 15-18 months.
Otroke so cepili s cepivom Prevenar (3 odmerki z enomesečnim presledkom od starosti 2 mesecev naprej), 46 od teh otrok pa so v starosti 15-18 mesecev cepili tudi s 23-valentnim polisaharidnim cepivom proti pnevmokokom.
If you forget to go back to the doctor or nurse at the scheduled time, ask the doctor or nurse for advice.
Če pozabite pripeljati otroka na cepljenje ob predpisanem času, se posvetujte z zdravnikom ali s
Most of the data have indicated that smaller proportions of infants achieved antibody concentrations ≥0.35 μg/ml (the reference antibody concentration recommended by
Podatki so večinoma pokazali, da je po primarnem zaporedju dveh odmerkov manjši del dojenčkov dosegel koncentracijo protiteles  0,35 µg/ml (referenčna koncentracija protiteles, ki jo priporoča SZO)
If this applies to your child, then the vaccination will be postponed until your child is feeling better.
V tem primeru bo zdravnik cepljenje odložil, dokler otrok ne bo ozdravel.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR VARIATION TO THE TERMS OF THE
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Prevenar is a pneumococcal vaccine.
Prevenar je pnevmokokno cepivo.
Important information about some of the ingredients of Prevenar: This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially sodium-free.
Pomembne informacije o nekaterih sestavinah cepiva Prevenar: To cepivo vsebuje manj kot 1 mmol natrija (23 mg) na odmerke, kar v bistvu pomeni 'brez natrija'.
In the per-protocol analysis, the estimated risk reduction for the first episode of clinical pneumonia with abnormal chest radiograph (defined as the presence of infiltrates, effusion or consolidation) was 35 % (95 % CI: 4, 56).
V analizi skladno s protokolom cepljenja je bilo ocenjeno zmanjšanje tveganja za prvi izbruh klinične pljučnice z nenormalno rentgensko sliko prsnega koša (opredeljeno kot prisotnost infiltratov, izliv ali konsolidacija) 35 % (95-odstotni interval zaupanja: 4, 56).
Prevenar can be given at the same time as other childhood vaccines; in this case different injection sites
Otrok lahko dobi cepivo Prevenar skupaj z drugimi cepivi za otroke; v tem primeru bo zdravnik izbral različna mesta injiciranja.
A fourth dose is recommended in the second year of life.
Četrti odmerek je priporočljivo dati v drugem letu življenja.
Different injectable vaccines should always be given at different
Različna parenteralna cepiva je treba vedno dati na različnih mestih.
More than 37,816 infants were immunised with either Prevenar or a control vaccine (meningococcal conjugate group C vaccine), at 2, 4, 6 and 12-15 months of age.
Več kot 37.816 dojenčkov je bilo cepljenih ali s cepivom Prevenar ali s kontrolnim cepivom (konjugirano meningokokno C cepivo) v 2., 4., 6. in 12. do 15. mesecu življenja.
Prevenar is for intramuscular use only.
Cepivo Prevenar je namenjeno samo za intramuskularno uporabo.
The interval between the pneumococcal conjugate vaccine (Prevenar) and the 23valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
Presledek med konjugiranim pnevmokoknim cepivom (Prevenar) in 23-valentnim pnevmokoknim polisaharidnim cepivom mora biti najmanj 8 tednov.
1 vial with syringe and 2 needles (1 for withdrawal, 1 for injection).
1 viala z 1 brizgo in 2 iglama (1 za odvzem, 1 za injiciranje).
In addition, GMCs were lower for antibodies to most serotypes after a twodose infant series than after a three-dose infant series.
Poleg tega so bile po seriji dveh odmerkov za dojenčke vrednosti GMC nižje za protitelesa proti večini serotipov kot po seriji treh odmerkov za dojenčke.
• The first injection may be given from 2 months of age
• Prvi odmerek lahko prejme od starosti šestih tednov naprej.
A higher rate of local reactions has been observed in children older than 24 months of age compared with infants (see section 4.8).
Pri otrocih, starejših od 24 mesecev, so opažali večjo pogostnost lokalnih reakcij kot pri dojenčkih (glejte poglavje 4.8).
HOW PREVENAR IS GIVEN
KAKO SE CEPIVO PREVENAR UPORABLJA
The antibody response to Hib tetanus protein conjugate (PRP-T), tetanus and Hepatitis B (HepB) vaccines was similar to controls.
Porast protiteles po cepljenju s konjugiranim cepivom proti bakteriji Haemophilus influenzae tipa B (Hib), vezanim na tetanusni protein (PRP-T), cepivom proti tetanusu in cepivom proti hepatitisu B (HepB) je bil podoben kot v kontrolnih skupinah.
Ask your pharmacist how to dispose of medicines no longer required.
O načinu odstranjevanja cepiva, ki ga ne potrebujete več, se posvetujte s farmacevtom.
Amongst the most commonly reported adverse reactions were injection site reactions and fever.
Med najpogostejšimi neželenimi učinki so bile reakcije na mestu cepljenja in zvišana telesna
Alternatively, when Prevenar is given as part of a routine infant immunisation programme, a two-dose schedule may be considered.
Kadar se cepivo Prevenar daje v okviru rutinskega programa cepljenja dojenčkov, lahko pride v poštev tudi shema z dvema odmerkoma.
The other ingredients are sodium chloride and water for injections.
Pomožni snovi sta natrijev klorid in voda za injekcije.
The vaccine serotype coverage in the paediatric population decreases with increasing age.
Pokritje serotipov v cepivu se pri otrocih s starostjo zmanjšuje.
When Prevenar is co-administered with hexavalent vaccines (DTaP/Hib(PRP-T)/IPV/HepB), fever ≥ 38 °C per dose was reported in 28.3 % to 48.3 % of infants in the group receiving Prevenar and the hexavalent vaccine at the same time as compared to 15.6 % to 23.4 % in the group receiving the hexavalent vaccine alone.
Če so Prevenar kombinirali s šestvalentnimi cepivi (DTaP/Hib(PRP-T)IPV/HepB), se je zvišana telesna temperatura  38 °C po enem odmerku pojavila pri 28,3 % do 48,3 % dojenčkov, medtem ko se je pri dojenčkih, ki so prejemali samo šestvalentno cepivo, ta pojavila samo pri 15,6 % do 23,4 %.
Redness was reported in 40.0 % of children, and induration was reported in 32.2 % of subjects.
Pordelost so zabeležili pri 40,0 % otrok, zatrdlino pa pri 32,2 %.