FrancophonIA/ELRC3.0 huggingface dataset:
English: This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent) (see section 5.1).
Slovenian: Tak odmerek cepiva Prevenar 13 je treba dati najmanj 8 tednov po zadnjem odmerku cepiva Prevenar (7-valentnega) (glejte poglavje 5.1).
English: Adults 18 to 49 years of age
Slovenian: Odrasli, stari od 18 do 49 let
English: Since the introduction of 7-valent Prevenar in 2000, pneumococcal disease surveillance data have not shown that the immunity elicited by Prevenar in infancy has waned over time.
Slovenian: Od uvedbe 7-valentnega cepiva Prevenar v letu 2000 podatki iz spremljanja poteka pnevmokokne bolezni niso pokazali, da bi imunost, povzročena s cepivom Prevenar v otroštvu, s časom pojemala.
English: In the second year after the introduction of Prevenar 13 the total number of CAP cases due to the 6 additional vaccine serotypes in Prevenar 13 was reduced from 27 to 7 isolates (74%).
Slovenian: V drugem letu po uvedbi cepiva Prevenar 13 se je skupno število primerov CAP zaradi 6 dodatnih serotipov v cepivu Prevenar 13 zmanjšalo s 27 na 7 izolatov (74 %).
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO CEPIVA
English: The duration of protective efficacy against a first episode of VT pneumococcal CAP, NB/NI VT pneumococcal CAP, and VT-IPD extended throughout the 4-year study.
Slovenian: Učinkovitost zaščite proti prvi epizodi VT-pnevmokokne CAP, NB/NI VT-pnevmokokne CAP in VT-IPD je trajala ves čas 4-letne študije.
English: The proportions of functional antibody responders (OPA titres ≥ 1:8) to serotypes 1, 3 and 5 were high.
Slovenian: Deleži bolnikov, ki so se odzvali s tvorbo delujočih protiteles (titri OPA ≥ 1:8) za serotipe 1, 3 in 5, so bili veliki.
English: • Periodic Safety Update Reports
Slovenian: • Redno posodobljena poročila o varnosti cepiva (PSUR)
English: A third dose is recommended in the second year of life.
Slovenian: Tretji odmerek prejmejo v drugem letu življenja.
English: Prevenar 13 must not be mixed with any other vaccines in the same syringe.
Slovenian: Cepiva Prevenar 13 ne smete mešati z drugimi cepivi v isti injekcijski brizgi.
English: Blood and lymphatic system disorders: Lymphadenopathy (localised to the region of the vaccination-site)
Slovenian: Bolezni krvi in limfatičnega sistema: limfadenopatija (omejena na predel mesta cepljenja)
English: Talk to your doctor, pharmacist, or nurse before the vaccination if you or your child:
Slovenian: Pred cepljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če ste imeli vi ali vaš otrok:
English: Immune responses as measured by IgG GMCs were assessed in 168-211 evaluable subjects approximately 1 month after vaccination.
Slovenian: Imunski odziv so ocenili z IgG GMC pri 168-211 ocenljivih preskušancih približno 1 mesec po cepljenju.
English: Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunisation.
Slovenian: Pri posameznikih z oslabljeno imunsko odzivnostjo zaradi uporabe imunosupresivnih zdravil, genetske motnje, okužbe z virusom HIV ali drugih vzrokov, je imunski odziv na aktivno imunizacijo lahko zmanjšan.
English: The active substances are polysaccharide CRM197 conjugates consisting of:
Slovenian: Učinkovine so polisaharidi, konjugirani na CRM197, sestavljeni iz:
English: The vaccine should be given by intramuscular injection.
Slovenian: Cepivo je treba injicirati intramuskularno.
English: It is unknown whether immunological memory to all serotypes is induced in pre-term infants.
Slovenian: Ni znano, ali pri nedonošenčkih pride do indukcije imunološkega spomina za vse serotipe.
English: • Severe allergic reaction including shock (cardiovascular collapse); angioedema (swelling of lips, face or throat)
Slovenian: • huda alergijska reakcija, vključno s šokom (kardiovaskularni kolaps); angioedem (otekanje ustnic, obraza ali žrela)
English: Once opened, the product may be stored for a maximum of 28 days at 2-8
Slovenian: Po odprtju lahko izdelek shranjujete največ 28 dni pri temperaturi med 2 °C in 8 °C.
English: • Allergic (hypersensitivity) reaction, including swelling of the face and/or lips, difficulty in breathing
Slovenian: • alergijska (preobčutljivostna) reakcija, vključno z oteklino obraza in/ali ustnic, težko dihanje
English: What Prevenar 13 is and what it is used for What you need to know before you or your child receives Prevenar 13 How Prevenar 13 is given
Slovenian: Kaj je cepivo Prevenar 13 in za kaj ga uporabljamo Kaj morate vedeti, preden boste vi ali vaš otrok prejeli cepivo Prevenar 13 Kako se cepivo Prevenar 13 uporablja Možni neželeni učinki
English: OPA geometric mean titers (GMTs) measured 1-month after each vaccination were calculated.
Slovenian: Izračunane so bile geometrične sredine titrov (GMT) OPA, izmerjene 1 mesec po vsakem cepljenju.
English: NCKP: Clinical pneumonia with abnormal chest X-ray
Slovenian: NCKP: klinična pljučnica z nenormalnim rentgenogramom prsnega koša
English: Children 5 to 17 years of age may receive a single dose of Prevenar 13 if they have been previously vaccinated with one or more doses of Prevenar.
Slovenian: Otroci, stari od 5 do 17 let, lahko prejmejo enkratni odmerek cepiva Prevenar 13, če so bili predhodno cepljeni z enim ali več odmerki cepiva Prevenar.
English: Correspondingly, OPA GMTs were similar in both groups, except for serotype 3, which was lower, and serotype 18C, which was higher, in the group that received Prevenar 13 with 2-PE.
Slovenian: Ustrezno so bile ravni OPA GMT pri obeh skupinah podobne, razen za serotip 3, kjer je bila raven nižja, in serotip 18C, kjer je bila raven višja pri skupini, ki je prejemala Prevenar 13 s konzervansom 2-PE.
English: In general, adverse events reported with overdose are consistent with those that have been reported with doses given in the recommended paediatric schedules of Prevenar 13.
Slovenian: Na splošno so bili neželeni učinki, o katerih so poročali pri prevelikem odmerjanju, enaki tistim, o katerih so poročali pri uporabi odmerkov v okviru priporočenih pediatričnih shem cepiva Prevenar 13.
English: Immune system disorders: Anaphylactic/anaphylactoid reaction including shock; angioedema
Slovenian: Bolezni imunskega sistema: anafilaktična/anafilaktoidna reakcija, vključno s šokom; angioedem
English: 18-49 Years N=836-866
Slovenian: 18-49 let n = 836-866
English: Limited data have demonstrated that Prevenar 7-valent (three-dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups (see section 5.1).
Slovenian: Omejeni podatki kažejo, da 7-valentno cepivo Prevenar (osnovno cepljenje s tremi odmerki) pri dojenčkih s srpastocelično anemijo sproži sprejemljiv imunski odziv s podobnim varnostnim profilom kot so ga opazili pri skupinah, ki nimajo velikega tveganja (glejte poglavje 5.1).
English: A Poisson regression model with random effects was used to calculate VE.
Slovenian: Za izračun UC so uporabili Poissonov model regresije z naključnimi učinki.
English: In an open-label study in 592 healthy children and adolescents including those with asthma (17.4%) who may be predisposed to pneumococcal infection, Prevenar 13 elicited immune responses to all 13 serotypes.
Slovenian: V odprti študiji, v kateri je sodelovalo 592 zdravih otrok in mladostnikov, vključno s tistimi z astmo (17,4 %), za katere velja, da so nagnjeni k pnevmokoknim okužbam, je cepivo Prevenar 13 izzvalo imunski odziv na vseh 13 serotipov.
English: Approximately one month after the toddler dose, the proportion of subjects in each group achieving this same antibody concentration threshold was >97%, except for serotype 3 (71% in preterm infants and 79% in term infants).
Slovenian: Približno en mesec po pediatričnem odmerku je bil delež preskušancev v vsaki skupini, ki je dosegla enak prag za koncentracijo protiteles, > 97 %, razen za serotip 3 (71 % pri nedonošenčkih in 79 % pri donošenčkih).
English: Recommended schedule
Slovenian: Priporočena shema
English: The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine into your arm or your child's arm or leg muscle.
Slovenian: Priporočeni odmerek cepiva (0,5 ml) vam bo v mišico na roki oziroma bo otroku v mišico na roki ali nogi injiciral zdravnik ali medicinska sestra.
English: A trend to lower frequency of adverse reactions was associated with greater age; adults > 65 years of age (regardless of prior pneumococcal vaccination status) reported fewer adverse reactions than younger adults, with adverse reactions generally most common in the youngest adults, 18 to 29 years of age.
Slovenian: Trend zmanjševanja pogostnosti neželenih učinkov je bil povezan z večjo starostjo; pri odraslih, starejših od 65 let (ne glede na to, ali so bili predhodno že cepljeni proti pnevmokokom), so poročali o manj neželenih učinkih kot pri mlajših odraslih, neželeni učinki pa so se na splošno najpogosteje pojavljali pri najmlajših odraslih, starih od 18 do 29 let.
English: As recommended by the World Health Organization (WHO) the assessment of potential efficacy against IPD in infants and young children has been based on a comparison of immune responses to the seven common serotypes shared between Prevenar 13 and Prevenar, for which protective efficacy has been proven (for Prevenar (7-valent) efficacy in infants and children, see below).
Slovenian: Po priporočilih Svetovne zdravstvene organizacije (SZO) ocena možne učinkovitosti zaščite pred IPD pri dojenčkih in majhnih otrocih temelji na primerjavi imunskih odzivov na sedem serotipov, ki so skupni cepivoma Prevenar 13 in Prevenar, za katere je bila dokazana učinkovitost zaščite (za učinkovitost cepiva Prevenar (7-valentnega) pri dojenčkih in otrocih glejte spodaj).
English: This will help to lower some of the side effects of Prevenar 13.
Slovenian: To pomaga ublažiti nekatere neželene učinke cepiva Prevenar 13.
English: Severe vaccination-site pain/tenderness and severe limitation of arm movement was very common in adults 18 to 39 years and common in all other age groups.
Slovenian: Huda bolečina/občutljivost na mestu cepljenja in močno omejena sposobnost gibanja roke je bila zelo pogosta pri odraslih, starih od 18 do 39 let, in pogosta v vseh drugih starostnih skupinah.
English: Using the screening method, serotype-specific effectiveness estimates for 2 doses under the age of 1 year in the UK were 66 % (-29, 91 %) and 100 % (25, 100 %) for serotype 6B and 23F, respectively.
Slovenian: Z metodo presejanja so učinkovitost, specifično za serotip, za 2 odmerka do starosti 1 leta v Veliki Britaniji ocenili na 66 % (-29, 91 %) oziroma 100 % (25, 100 %) za serotip 6B oziroma 23F.
English: Efficacy against vaccine-type (VT) pneumococcal CAP and IPD was assessed in a large-scale randomised double-blind, placebo-controlled study (Community-Acquired Pneumonia Immunization Trial in Adults-CAPiTA) in the Netherlands.
Slovenian: Učinkovitost proti CAP in IPD, povzročenima z vrsto, prisotno v cepivu (VT - vaccine-type), so ocenili v obsežni, randomizirani, dvojno slepi s placebom nadzorovani študiji (CAPiTA - CommunityAcquired Pneumonia Immunization Trial in Adults) na Nizozemskem.
English: Safety was evaluated in 592 children (294 children aged 5 to 10 years previously immunised with at least one dose of Prevenar and 298 children aged 10 to 17 years who had not received a pneumococcal vaccine).
Slovenian: Varnost je bila ocenjena pri 592 otrocih (294 otrok, starih od 5 do 10 let, ki so bili predhodno cepljeni z vsaj enim odmerkom cepiva Prevenar in 298 otrok, starih od 10 do 17 let, ki niso prejeli pnevmokoknega cepiva).
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to diphtheria toxoid.
Slovenian: Preobčutljivost na učinkovine, katerokoli pomožno snov, navedeno v poglavju 6.1, ali davični toksoid.
English: Additional Prevenar (7-valent) immunogenicity data: children with sickle cell disease The immunogenicity of Prevenar has been investigated in an open-label, multicentre study in 49 infants with sickle cell disease.
Slovenian: Dodatni podatki o imunogenosti cepiva Prevenar (7-valentnega): otroci s srpastocelično anemijo Imunogenost cepiva Prevenar so preučevali v odprti multicentrični študiji pri 49 dojenčkih s srpastocelično anemijo.
English: After the booster dose, all vaccine serotypes including 6B and 23F had immune responses consistent with adequate priming with a two-dose primary series.
Slovenian: Po obnovitvenem odmerku so imeli vsi serotipi cepiva, tudi 6B in 23F, imunske odzive skladne z ustreznim osnovnim cepljenjem z dvema odmerkoma.
English: In all infant studies, Prevenar 13 was co-administered with routine paediatric vaccines (see section 4.5).
Slovenian: V vseh študijah pri dojenčkih so dojenčki cepivo Prevenar 13 prejeli skupaj z rutinskimi otroškimi cepivi (glejte poglavje 4.5).
English: At the end of this period Prevenar 13 should be used or discarded.
Slovenian: Po preteku navedenega časa je treba cepivo Prevenar 13 uporabiti ali zavreči.
English: Skin and subcutaneous tissue disorders: Erythema multiforme
Slovenian: Bolezni kože in podkožja: multiformni eritem
English: Functional antibody titers (OPA titers) were not measured in this study.
Slovenian: V tej študiji niso merili funkcionalnih titrov protiteles (titrov OPA).
English: For 9 serotypes, the OPA titers were shown to be statistically significantly greater in Prevenar 13 recipients.
Slovenian: Za 9 serotipov so, kar zadeva titre OPA, pokazali, da so bili statistično pomembno večji pri prejemnikih cepiva Prevenar 13.
English: The protective efficacy of Prevenar 13 against IPD has not been studied.
Slovenian: Učinkovitosti cepiva Prevenar 13 za zaščito pred IPD niso preučevali.
English: Prevenar 13 will only protect against ear infections in children caused by the types of Streptococcus pneumoniae for which the vaccine has been developed.
Slovenian: Cepivo Prevenar 13 lahko otroke ščiti le pred okužbami ušes, ki jih povzročajo tipi bakterije Streptococcus pneumoniae, za katere je bilo cepivo razvito.
English: There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women.
Slovenian: Podatkov o uporabi 13-valentnega pnevmokoknega konjugiranega cepiva pri nosečnicah ni.
English: Individuals with a blood-forming stem cell transplant may receive three injections, with the first given at 3 to 6 months after the transplant and with an interval of at least 1 month between doses.
Slovenian: Posamezniki s presadkom krvotvornih matičnih celic lahko prejmejo tri odmerke cepiva, pri čemer se prvo cepljenje opravi od 3 do 6 mesecev po presaditvi, med odmerki pa mora miniti vsaj en mesec.
English: Immune responses were assessed in 259-270 evaluable subjects approximately 1 month after each dose of vaccine.
Slovenian: Imunski odziv so ocenili pri 259-270 ocenljivih preskušancih približno 1 mesec po vsakem odmerku cepiva.
English: However, 3 (serotypes 1, 5 and 6A) of the 6 additional serotypes showed lower IgG GMC and OPA GMT when compared with children who had received at least one previous vaccination with
Slovenian: Vendar pa je pri 3 (serotipi 1, 5 in 6A) izmed 6 dodatnih serotipov prišlo do nižje ravni IgG GMC in OPA GMT v primerjavi z otroki, pri katerih je bilo opravljeno najmanj eno predhodno cepljenje s cepivom Prevenar 13.
English: GMT GMR (95% CI)
Slovenian: GMT GMR (95 % IZ)
English: Studies of Prevenar 13 not containing the preservative 2-PE
Slovenian: Študije cepiva Prevenar 13, ki ne vsebuje konzervansa 2-PE
English: Vaccine serotypes: 98% All serotypes: 77%
Slovenian: Serotipi cepiva: 98 % Vsi serotipi: 77 %
English: In the study 162 subjects had received one prior dose of 23-valent pneumococcal polysaccharide vaccine, 143 subjects 2 prior doses and 26 subjects more than 2 prior doses of 23-valent polysaccharide vaccine.
Slovenian: V študiji je 162 oseb prejelo en predhoden odmerek 23-valentnega pnevmokoknega polisaharidnega cepiva, 143 oseb dva predhodna odmerka in 26 oseb več kot dva predhodna odmerka 23-valentnega polisaharidnega cepiva.
English: Unvaccinated infants, children, and adolescents over 7 months of age
Slovenian: Necepljeni dojenčki, otroci in mladostniki, starejši od 7 mesecev
English: IRR is calculated as the incidence in the placebo group minus the incidence in the vaccine group, and was mathematically equivalent to VE × the incidence in the placebo group.
Slovenian: IRR so izračunali kot incidenco v skupini s placebom, od katere so odšteli incidenco v skupini s cepivom, in je matematično enakovredna UC, pomnoženi z incidenco v skupini s placebom.
English: In clinical studies, Prevenar 13 elicited an immune response to all thirteen serotypes included in the vaccine.
Slovenian: V kliničnih študijah je cepivo Prevenar 13 izzvalo imunski odziv na vseh trinajst serotipov, ki so vključeni v cepivo.
English: The need for revaccination with a subsequent dose of Prevenar 13 has not been established.
Slovenian: Potreba po ponovnem cepljenju z naslednjim odmerkom cepiva Prevenar 13 ni bila dokazana.
English: Vaccine serotypes: Two doses under age 1: 85%
Slovenian: Serotipi cepiva: dva odmerka pred dopolnjeno starostjo 1 leta: 85 %
English: Each study included healthy adults and immuno-competent adults with stable underlying conditions known to predispose individuals to pneumococcal infection (i.e., chronic cardiovascular disease, chronic pulmonary disease including asthma, renal disorders and diabetes mellitus, chronic liver disease including alcoholic liver disease), and adults with risk factors such as smoking and alcohol abuse.
Slovenian: V vsaki študiji so sodelovali zdravi odrasli in imunokompetentni odrasli s stabilnimi osnovnimi boleznimi, za katere je znano, da pri posameznikih povzročijo nagnjenost k pnevmokokni okužbi (npr. kronična srčnožilna bolezen, kronična pljučna bolezen, vključno z astmo, bolezni ledvic in sladkorna bolezen, kronična bolezen jeter, vključno z alkoholno boleznijo jeter), in odrasli z dejavniki tveganja, kot sta na primer kajenje in zloraba alkohola.
English: Concomitant use with other vaccines has not been investigated.
Slovenian: Sočasne uporabe z drugimi cepivi niso raziskali.
English: Prevenar 13 is for intramuscular use only.
Slovenian: Cepivo Prevenar 13 je namenjeno samo za intramuskularno uporabo.
English: Additionally, all 13 serotypes met the pre-defined non-inferiority criterion for IgG GMCs (lower bound of the 97.5% CI of GMC ratio [GMR] was greater than 0.5).
Slovenian: Poleg tega je vseh 13 serotipov ustrezalo predhodno določenim merilom enakovrednosti za IgG GMC (spodnja meja 97,5 % IZ za razmerje GMC [GMR] je bila večja od 0,5).
English: Diarrhoea; vomiting (in adults aged 18 to 49 years)
Slovenian: diareja, bruhanje (pri odraslih, starih od 18 do 49 let)
English: Hypersensitivity reaction including face oedema, dyspnoea, bronchospasm
Slovenian: preobčutljivostna reakcija, vključno z edemom obraza, dispnejo in bronhospazmom
English: NB/NI - non-bacteraemic/non-invasive VT-IPD - vaccine-type invasive pneumococcal disease
Slovenian: NB/NI - nebakteriemijska/neinvazivna VT-IPD - invazivna pnevmokokna bolezen, povzročena z VT
English: For these 3 serotypes, the proportion of responders among preterm infants was significantly lower than among term infants.
Slovenian: Pri teh 3 serotipih je bil delež nedonošenčkov z odzivom pomembno manjši kot pri donošenčkih.
English: • Fever of more than 39°C; tenderness at the vaccination-site interfering with movement, redness,
Slovenian: • vročina, višja od 39 °C; občutljivost na mestu cepljenja, ki ovira gibanje, rdečina, zatrdlina,
English: As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness.
Slovenian: Kot pri drugih cepivih je treba tudi cepljenje s cepivom Prevenar 13 odložiti pri osebah, ki imajo hudo akutno vročinsko bolezen.
English: • Vomiting (for those 50 years and older); fever (for those 30 years and older)
Slovenian: • bruhanje (pri osebah, starih 50 let in več), vročina (pri osebah, starih 30 let in več)
English: For serotype 3, the percentages of Prevenar 13 recipients with serum IgG ≥ 0.35 μg/ml were 98.2% (study 006) and 63.5% (study 004).
Slovenian: Za serotip 3 sta bila odstotka prejemnikov cepiva Prevenar 13 s serumsko koncentracijo IgG ≥ 0,35 µg/ml 98,2 % (študija 006) in 63,5 % (študija 004).
English: Vomiting (in adults aged 50 years and over)
Slovenian: bruhanje (pri odraslih, starih 50 let in več)
English: Adults aged 50 years and older
Slovenian: Odrasli, stari 50 let in več
English: Children and adolescents aged 2-17 years One single dose of 0.5 ml.
Slovenian: Otroci in mladostniki, stari od 2 do 17 let En sam odmerek po 0,5 ml.
English: Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to Prevenar 13 suggest that administration of paracetamol concomitantly or within the same day of vaccination may reduce the immune response to Prevenar 13 after the infant series.
Slovenian: Podatki iz klinične študije, izvedene v obdobju trženja, ki je ocenjevala vpliv profilaktične uporabe antipiretikov (ibuprofena in paracetamola) na imunski odziv na cepivo Prevenar 13, kažejo, da lahko uporaba paracetamola sočasno ali v istem dnevu kot cepljenje zmanjša imunski odziv na cepivo Prevenar 13 pri cepljenju dojenčkov.
English: Higher frequency in some solicited systemic reactions was observed when Prevenar 13 was administered concomitantly with trivalent inactivated influenza vaccine (TIV) compared to TIV given alone (headache, chills, rash, decreased appetite, arthralgia, and myalgia) or Prevenar 13 given alone (headache, fatigue, chills, decreased appetite, and arthralgia).
Slovenian: Večja pogostnost nekaterih poročanih sistemskih reakcij je bila opažena ob sočasnem dajanju cepiva Prevenar 13 s trivalentnim inaktiviranim cepivom proti gripi (TIV) v primerjavi s samostojno danim cepivom TIV (glavobol, mrzlica, izpuščaj, zmanjšan apetit, artralgija in mialgija) ali samostojno danim cepivom Prevenar 13 (glavobol, utrujenost, mrzlica, zmanjšan apetit in artralgija).
English: In a similar analysis, hospitalisations and ambulatory visits for all-cause pneumonia were reduced by 52.4 % and 41.1 %, respectively.
Slovenian: V podobni analizi so se sprejemi na zdravljenje v bolnišnico zaradi pljučnice ne glede na vzrok zmanjšali za 52,4 %, ambulantni pregledi pa za 41,1 %.
English: Infants aged 7-11 months
Slovenian: Dojenčki, stari od 7 do 11 mesecev
English: In clinical studies, the safety profile of Prevenar 13 was similar to Prevenar.
Slovenian: V kliničnih študijah je bil varnostni profil cepiva Prevenar 13 podoben kot pri cepivu Prevenar.
English: Immunogenicity and safety of Prevenar 13 has been demonstrated in adults aged 18 years and older including those previously vaccinated with a pneumococcal polysaccharide vaccine.
Slovenian: Imunogenost in varnost cepiva Prevenar 13 so dokazali pri odraslih, starih 18 let in več, vključno s tistimi, ki so bili predhodno cepljeni s pnevmokoknim polisaharidnim cepivom.
English: Children younger than 2 years old should receive the appropriate-for-age Prevenar 13 vaccination series (see section 4.2).
Slovenian: Pri otrocih, mlajših od 2 let, je treba uporabiti starosti primerno shemo cepljenja s cepivom Prevenar 13 (glejte poglavje 4.2).
English: Immune responses to serotype 6A were statistically significantly greater following vaccination with Prevenar 13 than after 23-valent pneumococcal polysaccharide vaccine.
Slovenian: Imunski odzivi na serotip 6A so bili statistično pomembno večji po cepljenju s cepivom Prevenar 13 kot po cepljenju s 23-valentnim pnevmokoknim polisaharidnim cepivom.
English: hardness, swelling at the vaccination-site of 2.5 cm -7.0 cm (after the initial course of injections)
Slovenian: oteklina na mestu cepljenja s premerom 2,5 cm-7 cm (po začetni shemi injekcij)
English: Additional information in special populations
Slovenian: Dodatne informacije o posebnih populacijah