natgillin/translations-raw huggingface dataset:
Placebo group 
Skupina s placebom
18C 19A 19F 23F Non-inferiority was defined as the lower limit of the 2-sided 95% CI for GMR was greater than 0.5. 
18C 19A 19F 23F Enakovrednost je bila definirana s spodnjo mejno vrednostjo 2-stranskega 95 % intervala zaupanja (IZ) za GMR, večjo od 0,5.
In adults aged 18-49 years, OPA GMTs to all 13 serotypes in Prevenar 13 were non-inferior to the Prevenar 13 responses in adults aged 60-64 years. 
Pri odraslih, starih od 18 do 49 let, so bile vrednosti GMT OPA pri vseh 13 serotipih v cepivu Prevenar 13 enakovredne odzivom na cepivo Prevenar 13 pri odraslih, starih od 60 do 64 let.
As otitis media is caused by many organisms other than pneumococcal serotypes represented in the vaccine, protection against all otitis media is expected to be low (see section 5.1). 
Ker vnetje srednjega ušesa poleg pnevmokoknih serotipov, ki jih vsebuje cepivo, povzročajo še številni drugi mikroorganizmi, pričakujemo, da bo zaščita pred vnetjem srednjega ušesa majhna (glejte poglavje 5.1).
1 single-dose (0.5 ml) pre-filled syringe with separate needle 1 single-dose (0.5 ml) pre-filled syringe without needle 10 single-dose (0.5 ml) pre-filled syringes with separate needles 10 single-dose (0.5 ml) pre-filled syringes without needle 50 single-dose (0.5 ml) pre-filled syringes with separate needles 50 single-dose (0.5 ml) pre-filled syringes without needle 
1 enoodmerna (0,5 ml) napolnjena injekcijska brizga s priloženo injekcijsko iglo 1 enoodmerna (0,5 ml) napolnjena injekcijska brizga brez injekcijske igle 10 enoodmernih (0,5 ml) napolnjenih injekcijskih brizg s priloženimi injekcijskimi iglami 10 enoodmernih (0,5 ml) napolnjenih injekcijskih brizg brez injekcijskih igel 50 enoodmernih (0,5 ml) napolnjenih injekcijskih brizg s priloženimi injekcijskimi iglami 50 enoodmernih (0,5 ml) napolnjenih injekcijskih brizg brez injekcijskih igel
Prevenar 13 must not be administered intravascularly. 
Cepiva Prevenar 13 se ne sme aplicirati intravaskularno.
The recommended immunisation series consists of four doses, each of 0.5 ml. 
Priporočeno shemo cepljenja sestavljajo štirje odmerki po 0,5 ml.
Prevenar 13 can be given at the same time as other childhood vaccines; in this case, different vaccination sites should be used. 
Cepivo Prevenar 13 se lahko aplicira sočasno z drugimi cepivi proti otroškim boleznim.
Like all vaccines, Prevenar 13 can cause side effects, although not everybody gets them. 
Kot vsa cepiva ima lahko tudi cepivo Prevenar 13 neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
How Prevenar 13 is given 
Kako se cepivo Prevenar 13 uporablja
Adults previously vaccinated with 23-valent pneumococcal polysaccharide vaccine HIV-infected adults ≥ 18 years of age with CD4 ≥ 200 cells/µL (mean 609.1 cells/µL) and viral load < 50,000 copies/ml (mean 330.6 copies/ml), who were free of active AIDS-related illness and were previously vaccinated with 23-valent pneumococcal polysaccharide vaccine administered at least 6 months prior to enrollment, received 3 doses of Prevenar 13, at enrollment, 6 months, and 12 months after the first dose of Prevenar 13. 
Odrasli, predhodno cepljeni s 23-valentnim pnevmokoknim polisaharidnim cepivom Imunski odziv so ocenili pri z virusom HIV okuženih odraslih, starih ≥ 18 let, z vrednostmi CD4 ≥ 200 celic/µl (povprečje 609,1 celic/µl) in virusnim bremenom < 50.000 kopij/ml (povprečje 330,6 kopij/ml), brez aktivne, z AIDS-om povezane bolezni in predhodno cepljenih s 23-valentnim pnevmokoknim polisaharidnim cepivom vsaj 6 mesecev pred vključitvijo v študijo.
The fourth (booster) dose is recommended between 11 and 15 months of age (see sections 4.4 and 
Cepljenje s četrtim (obnovitvenim) odmerkom je priporočljivo opraviti v starosti od 11. do 15. meseca (glejte poglavji 4.4 in 5.1).
For each of the seven common serotypes, > 96% and > 90% of the Prevenar 13 recipients reached an OPA titre ≥ 1:8 one month after the primary series in studies 006 and 004, respectively. 
Za vsakega od 7 skupnih serotipov je > 96 % prejemnikov cepiva Prevenar 13 v študiji 006 in > 90 % prejemnikov cepiva Prevenar 13 v študiji 004 doseglo titre OPA ≥ 1:8 en mesec po osnovnem cepljenju.
Your child will receive an initial course of three injections. 
Vaš otrok bo med osnovnim cepljenjem prejel tri odmerke cepiva.
The fourth (booster) dose is recommended between 11 and 15 months of age. 
Cepljenje s četrtim (obnovitvenim) odmerkom je priporočljivo opraviti v starosti od 11. do 15. meseca.
Two-dose primary series 
Osnovna shema z dvema odmerkoma
The following frequencies are based on adverse reactions assessed in Prevenar 13 clinical studies: 
Naslednji podatki o pogostnosti temeljijo na neželenih učinkih iz kliničnih študij cepiva Prevenar 13:
Irritability; any vaccination-site erythema; induration/swelling or pain/tenderness; somnolence; poor quality sleep; vaccination-site tenderness (including impaired movement) 
razdražljivost; rdečina, zatrdlina/oteklina ali bolečina/občutljivost na mestu cepljenja; somnolenca, motnje spanja; občutljivost na mestu cepljenja (vključno z motnjami gibanja)
Table 8 shows OPA GMTs 1-month after a single dose of Prevenar 13 in 18-49 year olds compared to 60-64 year olds. 
V preglednici 8 je predstavljena primerjava geometričnih sredin titrov (GMT) OPA 1 mesec po prejemu enkratnega odmerka cepiva Prevenar 13 pri 18 do 49 let starih osebah ter 60 do 64 let starih osebah.
However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines. 
Cepivo Prevenar 13 nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev, vendar lahko nekateri neželeni učinki, omenjeni v poglavju 4.8, začasno vplivajo na sposobnost vožnje in upravljanja strojev.
Pneumonia is the most common clinical presentation of pneumococcal disease in adults. 
Odrasli ≥ 18 let in starejši Pljučnica je najpogostejša klinična slika pnevmokokne bolezni pri odraslih.
The first dose may be given as early as six weeks of age. 
Cepljenje s prvim odmerkom se lahko opravi že pri starosti šestih tednov.
Children and Adolescents 5 to 17 years of age 
Otroci in mladostniki, stari od 5 do 17 let
Secondary endpoints First episode of confirmed NB/NI vaccine type pneumococcal CAP 
Prva epizoda potrjene NB/NI VT-pnevmokokne CAP
• Enlarged lymph nodes or glands (lymphadenopathy) near the vaccination-site, such as under the arm or in the groin 
• povečanje bezgavk (limfadenopatija) blizu mesta cepljenja, na primer v pazduhi ali dimljah
Prevenar 13 has no or negligible influence on the ability to drive and use machines. 
Cepivo Prevenar 13 nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev, vendar lahko nekateri neželeni učinki, omenjeni v poglavju 4, začasno vplivajo na sposobnost vožnje in upravljanja strojev.
Immune responses following a two-dose primary infant series 
Imunski odzivi po osnovnem cepljenju dojenčkov z dvema odmerkoma
Please speak to your doctor, pharmacist, or nurse for more information. 
Za več informacij se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Haematopoietic stem cell transplant 
Presadek hematopoetskih matičnih celic
Sodium chloride Succinic acid Polysorbate 80 
6.1 Seznam pomožnih snovi natrijev klorid jantarna kislina polisorbat 80
Pack sizes of 1, 5, 10, 25 and 50 vials. 
Velikosti pakiranja po 1, 5, 10, 25 in 50 vial.
Children aged 2 to 17 years should receive one injection. 
Otroci, stari od 2 do 17 let, morajo prejeti en odmerek cepiva.
Vaccination-site erythema, induration/swelling > 7.0 cm; crying 
rdečina ali zatrdlina/oteklina na mestu cepljenja > 7,0 cm, jok
• Enlarged lymph nodes or glands (lymphadenopathy) near the vaccination-site, such as under the arm 
• povečanje bezgavk (limfadenopatija) blizu mesta cepljenja, na primer v pazduhi
Talk to your doctor, pharmacist, or nurse before the vaccination if your child was born very prematurely (at or before 28 weeks of gestation), as longer gaps than normal between breaths may occur for 2-3 days after vaccination. 
Če je bil vaš otrok rojen veliko prezgodaj (v 28. tednu nosečnosti ali prej), se pred cepljenjem posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, saj se lahko 2-3 dni po cepljenju pojavijo nenormalno dolgi presledki med posameznimi vdihi.
• has a weakened immune system (such as due to HIV infection), you/she/he may not get the full benefit from Prevenar 13. 
• oslabljen imunski sistem (na primer zaradi okužbe z virusom HIV).
In adults aged 50-59 years, OPA GMTs to all 13 serotypes in Prevenar 13 were non-inferior to the Prevenar 13 responses in adults aged 60-64 years. 
Pri odraslih, starih 50 do 59 let, so bile vrednosti geometričnih sredin titrov OPA pri vseh 13 serotipih pri cepivu Prevenar 13 enakovredne odzivom na cepivo Prevenar 13 pri odraslih, starih 60 do 64 let.
Table 9: OPA GMTs in pneumococcal polysaccharide vaccinated adults aged ≥ 70 years given either Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine (PPSV23) 
Preglednica 9: GMT OPA pri odraslih, starih ≥ 70 let, cepljenih s pnevmokoknim polisaharidnim cepivom, ki so prejeli bodisi cepivo Prevenar 13 bodisi 23-valentno pnevmokokno polisaharidno cepivo (PPSV23)
Relative to 60-64 Years 
18-49 let v primerjavi s 60-64 let
Adults with a blood-forming stem cell transplant had similar side effects however the frequencies were very common for fever and vomiting. 
Odrasli s presadkom krvotvornih matičnih celic so imeli podobne neželene učinke, vendar sta bila vročina in bruhanje zelo pogosta.
General disorders and administration site conditions: Very common: 
Splošne težave in spremembe na mestu aplikacije: Zelo pogosti:
Adults 50-59 years not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine 
Odrasli, stari 50-59 let, ki predhodno niso bili cepljeni s 23-valentnim pnevmokoknim polisaharidnim cepivom
0.5 ml suspension for injection in a vial (Type I glass) with a latex-free grey chlorobutyl rubber stopper and sealed with an aluminum flip-off seal and a polypropylene flip-off cap. 
0,5 ml suspenzije za injiciranje v viali (steklo tipa I) z zamaškom iz sive klorobutilne gume brez lateksa, s snemljivo zaporko iz aluminija ter snemljivim pokrovčkom iz polipropilena.
Pneumococcal polysaccharide serotype 9V 
2,2 µg pnevmokokni polisaharid serotipa 9V
Each injection will be given at least two months apart. 
Med obema odmerkoma morata miniti vsaj dva meseca.
1, 5, 10, 25, 50 single dose vials 
1, 5, 10, 25, 50 enoodmernih vial
Urticaria or urticaria-like rash 
urtikarija ali urtikariji podoben izpuščaj
Pneumococcal immune responses were compared using non-inferiority criteria, including the percentage of subjects with serum anti-polysaccharide serotype-specific IgG concentration ≥0.35 μg/ml and the comparison of IgG GMCs one month after the infant series. 
Imunske odzive proti pnevmokoku so primerjali z merili enakovrednosti, med drugim: odstotni delež preskušancev z vrednostjo za antipolisaharidni serotip specifičnih IgG v serumu ≥ 0,35 μg/ml in primerjava geometričnih srednjih koncentracij (GMC) IgG en mesec po shemi za dojenčke.
Immune responses to Prevenar 13 and 23-valent pneumococcal polysaccharide vaccine were compared in a head to head trial in adults aged ≥ 70 years, who had received a single dose of pneumococcal polysaccharide vaccine at least 5 years before study vaccination. 
Odrasli, ki so bili predhodno cepljeni s 23-valentnim pnevmokoknim polisaharidnim cepivom Imunske odzive na cepivo Prevenar 13 in 23-valentno pnevmokokno polisaharidno cepivo so v preskušanju, ki je potekalo po načelu neposredne primerjave, primerjali pri odraslih, starih ≥ 70 let, ki so prejeli en sam odmerek pnevmokoknega polisaharidnega cepiva najmanj 5 let pred študijskim cepljenjem.
However, in infants and children there have been reports of overdose with Prevenar 13 defined as subsequent doses administered closer than recommended to the previous dose. 
Vendar pa pri dojenčkih in otrocih obstajajo poročila o prevelikem odmerjanju cepiva Prevenar 13 v smislu dajanja zaporednih odmerkov cepiva v krajšem časovnem obdobju od priporočenega.
Adults ≥ 70 years vaccinated with 23-valent pneumococcal polysaccharide vaccine at least 5 years prior 
Odrasli, stari ≥ 70 let, cepljeni s 23-valentnim pnevmokoknim polisaharidnim cepivom najmanj 5 let pred vključitvijo v študijo
Overdose with Prevenar 13 is unlikely due to its presentation as a pre-filled syringe. 
Preveliko odmerjanje cepiva Prevenar 13 je malo verjetno, saj je cepivo na voljo v napolnjeni injekcijski brizgi.
Children aged 12-23 months Two doses, each of 0.5 ml, with an interval of at least 2 months between doses (see section 5.1). 
Otroci, stari od 12 do 23 mesecev Dva odmerka, vsak po 0,5 ml.
Overdose with Prevenar 13 is unlikely due to its presentation as a single dose vial. 
Preveliko odmerjanje cepiva Prevenar 13 je malo verjetno, saj je cepivo na voljo v enoodmerni viali.
• Vomiting; diarrhoea 
• bruhanje, driska
In adults aged 60-64 years, OPA GMTs to Prevenar 13 were non-inferior to the OPA GMTs elicited to the 23-valent pneumococcal polysaccharide vaccine for the twelve serotypes common to both vaccines. 
Pri odraslih, starih 60 do 64 let, so bile vrednosti geometričnih sredin titrov OPA po uporabi cepiva Prevenar 13 enakovredne vrednostim geometričnih sredin titrov OPA, ki jih je povzročilo 23-valentno pnevmokokno polisaharidno cepivo pri 12 serotipih, ki so skupni obema cepivoma.
Table 7 compares the OPA GMTs, 1-month post-dose, in 60-64 year olds given either a single dose of Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine, and in 50-59 year olds given a single dose of Prevenar 13. 
V preglednici 7 je predstavljena primerjava geometričnih sredin titrov (GMT) OPA 1 mesec po prejemu odmerka pri 60 do 64 let starih osebah, ki so prejele bodisi en sam odmerek cepiva Prevenar 13 bodisi 23-valentnega pnevmokoknega polisaharidnega cepiva, in pri 50 do 59 let starih osebah, ki so prejele en sam odmerek cepiva Prevenar 13.
Children and adolescents aged 6 to 17 years 
Otroci in mladostniki, stari od 6 do 17 let
Pneumococcal polysaccharide serotype 18C 
2,2 µg pnevmokokni polisaharid serotipa 18C
After the first vaccination, Prevenar 13 elicited antibody levels measured by both IgG GMCs and OPA GMTs that were statistically significantly higher when compared to levels prior to vaccination. 
Po prvem cepljenju je cepivo Prevenar 13 povzročilo ravni protiteles, izmerjene z IgG GMC in OPA GMT, ki so bile statistično pomembno višje v primerjavi z ravnmi pred cepljenjem.
Prevenar 13 contains sodium 
Cepivo Prevenar 13 vsebuje natrij
Metabolism and nutrition disorders: Very common: 
Presnovne in prehranske motnje: Zelo pogosti:
One year after vaccination with Prevenar 13 OPA titers had declined compared to one month after vaccination, however OPA titers for all serotypes remained higher than levels at baseline. 
Eno leto po cepljenju s cepivom Prevenar 13 so se titri OPA zmanjšali v primerjavi s titri 1 mesec po cepljenju, vendar pa so titri OPA za vse serotipe ostali večji od izhodiščnih ravni.
One year after vaccination with Prevenar 13 OPA titers had declined compared to one month after vaccination, however, OPA titers for all serotypes remained higher than levels at baseline: 
Eno leto po cepljenju s cepivom Prevenar 13 so se titri OPA zmanjšali v primerjavi s titri 1 mesec po cepljenju, vendar pa so titri OPA za vse serotipe ostali večji od izhodiščnih ravni:
Adults 60-64 years not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine 
Odrasli, stari 60-64 let, ki predhodno niso bili cepljeni s 23-valentnim pnevmokoknim polisaharidnim cepivom
Adults 18-49 years not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine 
Odrasli, stari 18-49 let, ki predhodno niso bili cepljeni s 23-valentnim pnevmokoknim polisaharidnim cepivom
The following side effects include those reported for Prevenar 13 in adults: 
O naslednjih neželenih učinkih so poročali pri uporabi cepiva Prevenar 13 pri odraslih:
Prevenar 13 significantly reduced newly identified NP acquisition of the 6 additional serotypes (and serotype 6C) combined and of individual serotypes 1, 6A, 6C, 7F, 19A when compared with Prevenar. 
Cepivo Prevenar 13 je v primerjavi s cepivom Prevenar pomembno zmanjšalo na novo ugotovljeno naselitev nosnožrelnega prostora za 6 dodatnih serotipov (in serotip 6C) v celoti ter za posamezne serotipe 1, 6A, 6C, 7F, 19A.
Prevenar 13 contains the 7 pneumococcal capsular polysaccharides that are in Prevenar (4, 6B, 9V, 14, 18C, 19F, 23F) plus 6 additional polysaccharides (1, 3, 5, 6A, 7F, 19A) all conjugated to CRM197 carrier protein. 
Cepivo Prevenar 13 vsebuje istih 7 pnevmokoknih kapsularnih polisaharidov kot cepivo Prevenar (4, 6B, 9V, 14, 18C, 19F, 23F) in še 6 dodatnih polisaharidov (1, 3, 5, 6A, 7F, 19A).
The clinical significance of this observation is unknown. 
Klinični pomen teh ugotovitev ni znan.
Table 9 compares the OPA GMTs, 1-month post-dose, in pneumococcal polysaccharide vaccinated adults aged ≥ 70 years given a single dose of either Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine. 
V preglednici 9 je predstavljena primerjava geometričnih sredin titrov (GMT) OPA 1 mesec po uporabi odmerka pri odraslih, starih ≥ 70 let, cepljenih s pnevmokoknim polisaharidnim cepivom, ki so prejeli en sam odmerek bodisi cepiva Prevenar 13 bodisi 23-valentnega pnevmokoknega polisaharidnega cepiva.
If you forget to go back at the scheduled time, ask the doctor, pharmacist, or nurse for advice. 
Če ste pozabili na cepljenje s predvidenim odmerkom ob dogovorjenem času, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Immune responses following a three-dose primary infant series 
Imunski odzivi po osnovnem cepljenju dojenčkov s tremi odmerki
Skin and subcutaneous tissue disorders: Very common: 
Bolezni kože in podkožja: Zelo pogosti:
Three-dose primary series 
Osnovna shema s tremi odmerki
An increase in vaccination-site reactions was reported in children older than 12 months compared to rates observed in infants during the primary series with Prevenar 13. 
Pri otrocih, starejših od 12 mesecev, so med osnovnim cepljenjem s cepivom Prevenar 13 pogosteje poročali o reakcijah na mestu cepljenja kot pri dojenčkih.
• Fever; irritability; pain, tenderness, redness, swelling or hardness at the vaccination-site; 
• razdražljivost; bolečina, občutljivost, rdečina, otekanje ali zatrdlina na mestu cepljenja,
In infants and children there have been reports of overdose with Prevenar 13 defined as subsequent doses administered closer than recommended to the previous dose. 
Pri dojenčkih in otrocih obstajajo poročila o prevelikem odmerjanju cepiva Prevenar 13 v smislu dajanja zaporednih odmerkov cepiva v krajšem časovnem obdobju od priporočenega.
Immune responses in preterm and term infants were compared using the proportion of subjects achieving a pneumococcal polysaccharide IgG binding antibody concentration ≥0.35 μg/mL 1 month after the infant series, the approach used for immunogenicity comparisons of Prevenar 13 to Prevenar based on WHO guidelines. 
Imunske odzive nedonošenčkov in donošenčkov so primerjali z deležem preskušancev, ki so dosegli koncentracijo protiteles IgG, ki se vežejo na pnevmokokne polisaharide, ki je ≥ 0,35 μg/ml 1 mesec po shemi za dojenčke; to je pristop, ki je bil za primerjavo imunogenosti cepiva Prevenar 13 in cepiva Prevenar uporabljen skladno s priporočili SZO.
Infants and children who have previously received Prevenar may receive Prevenar 13 to complete the course of injections. 
Pri dojenčkih in otrocih, ki so predhodno že prejeli odmerek cepiva Prevenar, se cepljenje lahko dokonča s cepivom Prevenar 13.
Antipyretic treatment should be initiated according to local treatment guidelines for children with seizure disorders or with a prior history of febrile seizures and for all children receiving Prevenar 13 simultaneously with vaccines containing whole cell pertussis. 
Pri otrocih z napadi krčev ali z anamnezo vročinskih krčev in vseh otrocih, ki prejmejo cepivo Prevenar 13 skupaj s cepivom proti oslovskemu kašlju s celimi celicami, je treba uvesti zdravljenje vročine v skladu z nacionalnimi smernicami.
Headaches 
glavoboli
EU/1/09/590/012 - pack of 1 multidose container EU/1/09/590/013- pack of 5 multidose containers EU/1/09/590/014- pack of 10 multidose containers EU/1/09/590/015 - pack of 25 multidose containers EU/1/09/590/016- pack of 50 multidose containers 
EU/1/09/590/012 - pakiranje po 1 večodmerni vsebnik EU/1/09/590/013 - pakiranje po 5 večodmernih vsebnikov EU/1/09/590/014 - pakiranje po 10 večodmernih vsebnikov EU/1/09/590/015 - pakiranje po 25 večodmernih vsebnikov EU/1/09/590/016 - pakiranje po 50 večodmernih vsebnikov
Pneumococcal polysaccharide serotype 7F 
4,4 µg pnevmokokni polisaharid serotipa 7F
A fourth (booster) dose of Prevenar 13 was administered 6 months after the third dose. 
Cepljenje s četrtim (obnovitvenim) odmerkom so prejeli 6 mesecev po tretjem odmerku.
Number needed to vaccinate 
Število ljudi, ki jih je treba cepiti
Incidence rate reduction (95% CI) 
Zmanjšanje incidence (95 % IZ)
7-valent Prevenar serotypes 
Serotipi 7-valentnega cepiva Prevenar
Adults with HIV infection had similar side effects however the frequencies were very common for fever, vomiting and common for nausea. 
Odrasli z okužbo s HIV so imeli podobne neželene učinke, vendar sta bila vročina in bruhanje zelo pogosta, slabost s siljenjem na bruhanje pa pogost.
In preterm infants, the recommended immunisation series consists of four doses, each of 0.5 ml. 
Pri nedonošenčkih priporočeno shemo cepljenja sestavljajo štirje odmerki po 0,5 ml.
Nervous system disorders: Common: 
Bolezni živčnega sistema: Pogosti:
EU/1/09/590/002 - pack of 1 with separate needle EU/1/09/590/001 - pack of 1 without needle EU/1/09/590/004 - pack of 10 with separate needles EU/1/09/590/003 - pack of 10 without needle EU/1/09/590/006 - pack of 50 with separate needles EU/1/09/590/005 - pack of 50 without needle 
EU/1/09/590/002 - pakiranje po 1 s priloženo injekcijsko iglo EU/1/09/590/001 - pakiranje po 1 brez injekcijske igle EU/1/09/590/004 - pakiranje po 10 s priloženimi injekcijskimi iglami EU/1/09/590/003 - pakiranje po 10 brez injekcijskih igel EU/1/09/590/006 - pakiranje po 50 s priloženimi injekcijskimi iglami EU/1/09/590/005 - pakiranje po 50 brez injekcijskih igel
Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Prevenar 13 and Infanrix hexa (see section 4.8). 
Pri sočasni uporabi cepiva Prevenar 13 s cepivom Infanrix hexa so opazili zvečano stopnjo poročanja konvulzij (z vročino ali brez nje) ter epizod hipotonije in zmanjšane odzivnosti (glejte poglavje 4.8).
• Seizures (or fits), including those caused by a high temperature 
• krči (konvulzije), vključno z vročinskimi krči
Adults with HIV infection have similar frequencies of adverse reactions, except that pyrexia and vomiting were very common and nausea common. 
Pogostnost neželenih učinkov pri odraslih z okužbo s HIV je bila podobna, z izjemo pireksije in bruhanja, ki sta bila zelo pogosta, in navzee, ki je bila pogosta.
The vaccine should be shaken well to obtain a homogeneous white suspension and should be inspected visually for any particulate matter and/or variation of physical aspect prior to administration. 
Pred cepljenjem morate cepivo pregledati glede prisotnosti kakršnihkoli vidnih delcev in/ali neobičajne spremembe videza.
EU/1/09/590/007 - pack of 1 vial EU/1/09/590/008 - pack of 5 vials EU/1/09/590/009 - pack of 10 vials EU/1/09/590/010 - pack of 25 vials EU/1/09/590/011 - pack of 50 vials 
EU/1/09/590/007 - pakiranje po 1 vialo EU/1/09/590/008 - pakiranje po 5 vial EU/1/09/590/009 - pakiranje po 10 vial EU/1/09/590/010 - pakiranje po 25 vial EU/1/09/590/011 - pakiranje po 50 vial
Unvaccinated infants and children ≥ 7 months of age 
Predhodno necepljeni dojenčki in otroci, stari 7 mesecev ali več