natgillin/translations-raw huggingface dataset:
Children below 2 years old (including those at high-risk) should receive the appropriate-for-age Prevenar vaccination series.
Pri otrocih, mlajših od 2 let (vključno z zelo ogroženimi), je treba uporabiti starosti primerno zaporedje cepljenj s cepivom Prevenar.
Clinical trial efficacy of the two-dose infant primary series plus a booster has not been established, and the clinical consequences of lower antibody concentrations against serotypes 6B and 23F after the two-dose
Učinkovitosti primarne serije za dojenčke z dvema odmerkoma in poživitvenim odmerkom niso dokazali in klinične posledice nižjih koncentracij protiteles proti serotipoma 6B in 23F po zaporedju za dojenčke z dvema odmerkoma niso znane.
Uncommon side effects (these may occur with up to 1 in 100 doses of the vaccine) are: • Rash/hives (urticaria)
Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 odmerkov cepiva) so: • izpuščaj/koprivnica (urtikarija)
Therefore, in view of available data the PRAC considered that changes to the conditions of the marketing
Odbor PRAC na podlagi razpoložljivih podatkov priporoča spremembo pogojev dovoljenja za promet z zdravilom.
A significant increase was seen in the concentrations of antibodies against the seven serotypes after the polysaccharide vaccination, suggesting that immunological memory was well established.
Koncentracije protiteles proti sedmim serotipom so se po cepljenju s polisaharidnim cepivom signifikantno zvišale, kar kaže na to, da je bil imunološki spomin že dobro vzpostavljen.
Bacteria can be responsible for 60-70% of clinical episodes of AOM.
Bakterije utegnejo zakriviti 60 % - 70 % kliničnih izbruhov AOM.
Significant increases in antibody (measured by ELISA) were seen for all vaccine serotypes following a three-dose primary series of Prevenar in infants and following booster doses although geometric mean concentrations varied between the 7 serotypes.
Znaten porast protiteles (izmerjen z ELISA) so ugotovili za vse serotipe, vključene v cepivo, po primarnem zaporedju treh odmerkov cepiva Prevenar pri dojenčkih in po poživitvenih odmerkih, čeprav so bile geometrične srednje koncentracije (GMC) 7-ih serotipov različne.
Efficacy of Prevenar against acute otitis media (AOM) was assessed in a randomised, double blind, clinical trial of 1,662 Finnish infants immunised with either Prevenar or a control vaccine (Hepatitis B vaccine), at 2, 4, 6 and 12-15 months of age.
Učinkovitost cepiva Prevenar pri preprečevanju akutnega vnetja srednjega ušesa (AOM) so preučevali v randomizirani dvojno slepi klinični študiji na 1.662 finskih dojenčkih, cepljenih bodisi s cepivom Prevenar bodisi s kontrolnim cepivom (cepivo proti hepatitisu B) v starosti 2, 4, 6 in 12-15 mesecev.
Children aged 24 months - 5 years: one single dose.
Otroci, stari od 24 mesecev do 5 let: en sam odmerek.
In the USA in the same time frame, there was a 94% reduction in vaccine type IPD in individuals under 5 years of age, compared to a pre-vaccine baseline (1998/99).
V ZDA so se v istem časovnem okviru IPD, povzročene s serotipi, ki so vključeni v cepivo, pri otrocih, mlajših od 5 let, v primerjavi z izhodiščem pred cepljenjem (1998/99) zmanjšale za 94 %.
The vaccine should be well shaken to obtain a homogeneous white suspension and be inspected visually for any particulate matter and/or variation of physical aspect prior to administration.
Cepivo je treba pred uporabo dobro pretresti, da nastane bela homogena suspenzija, in ga pred uporabo dobro pregledati, da ne vsebuje delcev in/ali ni drugačnega fizikalnega videza.
Limited data have demonstrated that Prevenar (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).
Obstaja nekaj podatkov, ki so pokazali, da Prevenar (primarno zaporedje treh odmerkov) pri dojenčkih z anemijo srpastih celic sproži sprejemljiv imunski odziv s podobnim varnostnim profilom kot pri skupinah, pri katerih tveganje ni veliko (glejte poglavje 5.1).
Efficacy of Prevenar against AOM was assessed as a secondary endpoint in the Kaiser Permanente trial.
Učinkovitost cepiva Prevenar proti akutnemu vnetju srednjega ušesa so ocenili kot sekundarni cilj učinkovitosti v študiji Kaiser Permanente.
urticaria or urticaria-like rash (hives)
koprivnica (urtikarija) ali srbenje
In a clinical trial that compared separate with concomitant administrations of Prevenar (three doses at 2, 3.5, 6 months and a booster dose at approximately 12 months) and Meningitec (meningococcal C conjugate vaccine; two doses at 2 and 6 months and a booster dose at approximately 12 months) there was no evidence of immune interference between the two conjugate vaccines after the primary series or after
V kliničnem preskušanju, ki je primerjalo samostojno uporabo cepiva Prevenar (trije odmerki pri 2, 3,5 in 6 mesecih ter poživitveni odmerek pri približno 12 mesecih starosti) in sočasno uporabo tega cepiva s cepivom Meningitec (konjugirano meningokokno C cepivo; 2 odmerka pri 2 in 6 mesecih in poživitveni odmerek pri približno 12 mesecih starosti), niso pokazali motečega imunskega vpliva v primarnih serijah ali po poživitvenem cepljenju ob sočasnem dajanju obeh cepiv.
Fever of greater than 39.5 °C per dose was observed in 0.6 to 2.8 % of infants receiving Prevenar and hexavalent vaccines (see section 4.4).
Telesno temperaturo  39,5 °C po enem odmerku so opazili pri 0,6 % do 2,8 % dojenčkov, ki so prejemali Prevenar in šestvalentno cepivo istočasno (glejte poglavje 4.4).
Administration of unconjugated pneumococcal polysaccharides at 13 months following the primary series with Prevenar elicited an anamnestic antibody response for the 7 serotypes included in the vaccine, indicating
Dajanje nekonjugiranih pnevmokoknih polisaharidov pri 13 mesecih po primarnem zaporedju cepljenja s cepivom Prevenar je izzvalo spominski protitelesni odziv na vseh 7 v cepivo vključenih serotipov, kar kaže, da je bilo prvo
This indirect or herd effect is due to a reduction in transmission of vaccine serotypes from immunised young children to the rest of the population and coincides with decreased nasopharyngeal carriage of vaccine serotypes.
Ta posredni ali skupinski učinek je posledica manjšega prenašanja serotipov, vključenih v cepivo, s cepljenih mlajših otrok na preostalo populacijo in sovpada z zmanjšanim prenašanjem serotipov, vključenih v cepivo, v nazofarinksu.
In Europe, the estimates of effectiveness in children less than 2 years of age range from 51 % to 79 % when considering vaccine coverage against serotypes causing invasive disease.
V Evropi se ocena učinkovitosti pri otrocih, mlajših od 2 let, giblje med 51 % in 79 %, če upoštevamo tudi pokritost serotipov, ki povzročajo IPD, s cepivom.
After primary immunisation, 95.6% of the subjects had antibody levels of at least 0.35 µg/ml for all seven serotypes found in Prevenar.
Po primarni imunizaciji je bila koncentracija protiteles pri 95,6 % preiskovancev za vseh sedem serotipov, prisotnih v cepivu Prevenar, vsaj 0,35 µg/ml.
Hypersensitivity to the active substances or to any of the excipients, or to diphtheria toxoid.
Preobčutljivost na zdravilne učinkovine, katerokoli pomožno snov cepiva ali za davični toksoid.
2 against serotypes 6B and 23F after two-dose primary series when directly or indirectly compared with three-dose primary series.
2 proti serotipoma 6B in 23F, če to neposredno ali posredno primerjamo s primarnim zaporedjem treh odmerkov.
Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from 2 months up to 5 years of age (see sections 4.2, 4.4 and 5.1).
Aktivna imunizacija proti boleznim, ki jih povzroča Streptococcus pneumoniae serotipov 4, 6B, 9V, 14, 18C, 19F in 23F (vključno s sepso, meningitisom, pljučnico, bakteriemijo in akutnim vnetjem srednjega ušesa) pri dojenčkih in otrocih od 2. meseca do 5. leta starosti (glejte poglavja 4.2, 4.4
1 against serotypes 6B and 23F after two-dose primary series when directly or indirectly compared with three-dose primary series.
1 proti serotipoma 6B in 23F, če to neposredno ali posredno primerjamo s primarnim zaporedjem treh odmerkov.
In a study, including 1,662 children, fever of  38 °C was reported in 41.2 % of children who received Prevenar simultaneously with DTP as compared to 27.9 % in the control group.
V študiji pri 1.662 otrocih, ki so skupaj s cepivom Prevenar prejeli tudi cepivo DTP, so poročali o zvišani telesni temperaturi  38 °C pri 41,2 % otrok; v kontrolni skupini pa samo pri 27,9 %.
Pack size of 1 vial with syringe and 2 needles (1 for withdrawal, 1 for injection).
Pakiranje s po 1 vialo z brizgo in 2 iglama (1 za odvzem, 1 za injiciranje).
In the first two years of the programme, with over 90% coverage, the observed effectiveness against IPD caused by vaccine serotypes was 93% (95% CI 75-98) for the 2 dose infant series and 100% (95% CI 91-100) for the completed schedule.
V prvih dveh letih programa z več kot 90odstotno pokritostjo je bila ugotovljena učinkovitost proti IPD, povzročenim s serotipi, vključenimi v cepivo, 93 % (95-odstotni interval zaupanja 75-98) pri zaporedju za dojenčke z 2 odmerkoma in 100 % (95-odstotni interval zaupanja 91-100) pri dokončanem programu.
However, antibody responses to booster doses in toddlers following two-dose or three-dose infant series were comparable for all 7 vaccine serotypes and indicated that both infant regimens had elicited adequate priming.
So pa bili odzivi protiteles na poživitvene odmerke pri malih otrocih po zaporedju dveh odmerkov ali treh odmerkov za dojenčke podobni pri vseh 7-ih v cepivo vključenih serotipih, kar kaže, da sta obe shemi za dojenčke izzvali ustrezno reakcijo na prvo cepljenje.
There have been reports of overdose with Prevenar, including cases of administration of a higher than recommended dose and cases of subsequent doses administered closer than recommended to the previous dose.
Obstajajo poročila o prevelikem odmerjanju cepiva Prevenar, in sicer vključno s poročili o večjem odmerku od priporočenega in poročila o aplikaciji cepiva po krajšem presledku od priporočenega.
Prevenar has also been shown to elicit functional antibodies (measured by opsonophagocytosis) to all vaccine serotypes following the primary series.
Dokazali so tudi, da Prevenar po primarnem zaporedju spodbuja funkcionalna protitelesa (merjena z opsonofagocitozo) proti vsem v cepivo vključenim serotipom.
The immune response to routine paediatric vaccines co-administered with Prevenar at different injection sites was assessed in 7 controlled clinical studies.
Imunski odgovor na običajna otroška cepiva, ki se dajejo istočasno s cepivom Prevenar na različna mesta, so proučevali v 7 kontroliranih kliničnih študijah.
Sufficient data regarding interference on the concomitant administration of other hexavalent vaccines with Prevenar are currently not available.
Zadostnih podatkov o interakcijah cepiva Prevenar z drugimi šestvalentnimi cepivi še ni.
Effectiveness (no microbiological confirmation of diagnosis was performed) against non-bacteraemic pneumonia was also assessed.
Ocenjevali so tudi učinkovitost cepiva proti pljučnici brez bakteriemije, v primerih, ko diagnoza pljučnice ni bila mikrobiološko potrjena.
OUTER CARTON TEXT - 10 pre-filled syringes pack without needle: pack for multi pack presentation (5 x 10), without blue box
BESEDILO NA ŠKATLI - 10 napolnjenih injekcijskih brizg brez igle: pakiranje z več zavitki (5x10), brez Blue box-a
In parallel, there was a 62% reduction in vaccine type IPD in individuals over 5 years of age.
Podobno so se IPD, povzročene s serotipi, ki so vključeni v cepivo, pri osebah, starejših od 5 let, zmanjšale za 62 %.
LABEL TEXT - Outer wrapper label to be applied on the transparent foil for multi pack presentation (5 x 10), including the blue box
BESEDILO NA NALEPKI - nalepka zunanjega ovoja, ki bo nalepljena na prozorni foliji z več zavitki (5x10), vključno z blue box-om
A third dose is recommended in the second year of life.
Tretji odmerek je priporočljivo dati v drugem letu življenja.
Repeated dose subcutaneous toxicity studies (13 weeks, 7 injections of the clinical dose, one every other week, followed by a 4-week recovery period) of Prevenar in rats and monkeys revealed no evidence of any significant local or systemic toxic effects.
Študije subkutane toksičnosti ponavljajočih se odmerkov (13 tednov, 7 injekcij kliničnega odmerka, ena vsak drugi teden, temu je sledilo 4-tedensko obdobje okrevanja) cepiva Prevenar na podganah in opicah niso pokazale nikakršnih znakov pomembnih lokalnih ali sistemskih toksičnih učinkov.
Suspension for injection in pre-filled syringe.
suspenzija za injiciranje v napolnjeni injekcijski brizgi
When compared with no vaccination, point estimates for the effectiveness of 2-, 3-, or 4-doses given on an infant schedule were similar: 96% (95% CI 88-99); 95% (95% CI 88-99); and 100% (95% CI 94-100), respectively.
V primerjavi z necepljenjem so bile točkovne ocene za učinkovitost 2, 3 ali 4 odmerkov, danih po shemi za dojenčke, podobne: 96 % (95-odstotni interval zaupanja 88-99); 95 % (95-odstotni interval zaupanja 88-99); oziroma 100 % (95-odstotni interval zaupanja 94-100).
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
- Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Different injectable vaccines should always be given at different injection sites.
Različna parenteralna cepiva se vedno dajejo na različna mesta.
The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11-15 months of age (see section 5.1)
Prvi odmerek se lahko da od starosti 2 mesecev naprej, drugega vsaj 2 meseca pozneje, tretji (poživitveni) odmerek pa v starosti 11-15 mesecev (glejte poglavje 5.1).
It is important to follow the instructions from the doctor, pharmacist, or nurse so that your child completes
Pomembno je, da upoštevate navodila zdravnika, farmacevta ali medicinske sestre, tako da otrok prejme vse predvidene odmerke cepiva v predvidenem času.
• Each injection will be given at least 1 month apart
• Vse nadaljnje odmerke bo prejel z vsaj enomesečnim presledkom med odmerki.
1 or 10 pre- filled syringes with or without needle Multi pack of 5 packs of 10 pre-filled syringes without needle.
1 ali 10 napolnjenih injekcijskih brizg z ali brez igle 5 setov s po 10 napolnjenimi injekcijskimi brizgami brez igel.
There are no data available to indicate whether the administration of 23-valent pneumococcal polysaccharide vaccine to unprimed children or to children primed with Prevenar might result in hyporesponsiveness to further doses of Prevenar.
Ni podatkov, ki bi kazali, ali uporaba 23-valentnega pnevmokoknega polisaharidnega cepiva pri otrocih, ki še niso bili cepljeni, ali pri otrocih, že cepljenih s cepivom Prevenar, lahko povzroči zmanjšano odzivnost na nadaljnje odmerke cepiva Prevenar.
Prevenar is given to children from 2 months to 5 years to help protect against diseases such as: meningitis, sepsis or bacteraemia (bacteria in blood stream), pneumonia and ear infection caused by seven types of the bacteria Streptococcus pneumoniae.
Cepivo Prevenar uporabljamo za cepljenje otrok, starih od 2 mesecev do 5 let, za zaščito pred boleznimi kot so: meningitis, sepsa ali bakteriemija (bakterije v krvi), pljučnica in okužbe ušesa, ki jih povzroča sedem tipov bakterije Streptococcus pneumoniae.
As many pathogens other than pneumococcal serotypes represented in the vaccine may contribute to the burden of pneumonia in children, protection against all clinical pneumonia is expected to be lower than for invasive pneumococcal disease.
Ker lahko k obremenitvi zaradi pljučnice pri otrocih prispevajo številni patogeni, ne samo pnevmokokni serotipi, ki so prisotni v cepivu, pričakujemo, da bo zaščita pred vsemi kliničnimi pljučnicami slabša kot zaščita pred invazivno pnevmokokno pljučnico.
When Prevenar is co-administered with hexavalent vaccines (DTaP/Hib(PRP-T)/IPV/HepB), the physician should be aware that data from clinical studies indicate that the rate of febrile reactions was higher compared to that occurring following the administration of hexavalent vaccines alone.
Če zdravnik kombinira cepivo Prevenar s šestvalentnim cepivom (DTaP/Hib(PRP-T)IPV/HepB), mora upoštevati, da se po podatkih iz kliničnih študij po kombiniranem cepljenju pogosteje pojavljajo vročinske reakcije kot po samem šestvalentnem cepivu.
The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas (see sections 4.4, 4.8 and 5.1).
Uporabo cepiva Prevenar določimo na osnovi uradnih priporočil, ki upoštevajo pomembnost invazivnih bolezni po starostnih skupinah kot tudi variabilnost različnih geografskih serotipov (glejte
As with any vaccine, Prevenar may not protect all individuals receiving the vaccine from pneumococcal disease.
Podobno kot druga cepiva tudi Prevenar ne zaščiti vseh cepljenih posameznikov pred boleznimi, ki jih povzročajo pnevmokoki.
0.5 ml suspension for injection in vial (Type I glass) with a grey butyl rubber stopper.
0,5 ml suspenzije za injiciranje v viali (steklo tipa I) s sivim butilnim gumijastim zamaškom.
• Hypersensitivity reaction, including swelling of the face and/or lips, difficulty in breathing, rash,
• preobčutljivostne/alergijske reakcije z otekanjem obraza in/ali ustnic, oteženo dihanje, izpuščaj,
The effectiveness of Prevenar against IPD (i.e. comprising the protection afforded by vaccination and from herd immunity due to reduced transmission of vaccine serotypes in the population) has been evaluated in national immunisation programmes that employ three-dose or two-dose infant series, each with booster doses.
Učinkovitost cepiva Prevenar proti invazivnim pnevmokoknim boleznim (IPD), ki jo sestavljata zaščita, ki jo nudi cepljenje, in kolektivna zaščita v populaciji zaradi zmanjšanega prenašanja serotipov, ki so vključeni v cepivo, so ovrednotili v nacionalnih programih cepljenja, v katerih so uporabljali zaporedje treh odmerkov ali zaporedje dveh odmerkov za dojenčke, vedno tudi s poživitvenimi odmerki.
Although some antibody response to diphtheria toxoid may occur, immunisation with this vaccine does not substitute for routine diphtheria immunisation.
Čeprav lahko po cepljenju s cepivom Prevenar pride do določenega imunskega odgovora na davični toksoid, to cepivo ne more nadomestiti običajnega cepljenja proti davici.
The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11-15 months of age.
Prvi odmerek se lahko da od starosti 2 mesecev naprej, drugega vsaj 2 meseca pozneje, tretji (poživitveni) odmerek pa v starosti 11-15 mesecev.
Limited data have demonstrated that Prevenar induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups.
Obstaja nekaj podatkov, ki so pokazali, da Prevenar pri dojenčkih z anemijo srpastih celic sproži sprejemljiv imunski odziv s podobnim varnostnim profilom kot pri skupinah, pri katerih tveganje ni veliko.
Data on concomitant administration of Prevenar with Infanrix hexa (DTaP/Hib(PRP-T)/IPV/HepB vaccine) have shown no clinically relevant interference in the antibody response to each of the individual antigens when given as a 3 dose primary vaccination.
Podatki o sočasni uporabi cepiva Infanrix hexa (DTaP/Hib(PRP-T)/IPV/HepB) s cepivom Prevenar kažejo, da ne pride do klinično pomembnih sprememb v tvorbi protiteles proti posameznim antigenom, če ga uporabimo kot osnovno cepljenje s tremi odmerki.
The vaccine should be given by intramuscular injection.
Cepivo se daje intramuskularno.
Like all vaccines, Prevenar can cause side effects, although not everybody gets them.
Kot vsa druga cepiva ima lahko tudi cepivo Prevenar neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
A higher rate of local reactions has been observed in children older than 24 months of age compared with infants.
Pri otrocih, starejših od 24 mesecev, so opažali večjo pogostnost lokalnih reakcij kot pri dojenčkih.
Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja za promet z zdravilom
The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children  24 months of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness or who are immunocompromised) placing them at higher risk for invasive disease due to Streptococcus pneumoniae.
Uporaba konjugiranega pnevmokoknega cepiva ne nadomesti uporabe 23-valentnega pnevmokoknega polisaharidnega cepiva pri otrocih, starih  24 mesecev z večjim tveganjem (kot so otroci z anemijo srpastih celic, asplenijo, okužbo s HIV, kroničnimi boleznimi ali drugače imunsko kompromitirani); pri njih kljub vsemu ostaja večje tveganje za invazivno okužbo z bakterijo Streptococcus pneumoniae.
- for children with seizure disorders or with a prior history of febrile seizures.
- pri otrocih s konvulzijami ali pri tistih, ki imajo v anamnezi vročinske krče.
As with other vaccines, the administration of Prevenar should be postponed in subjects suffering from acute, severe febrile illness.
Kot pri drugih cepljenjih je treba tudi cepljenje s cepivom Prevenar odložiti pri otrocih, ki imajo akutno hudo vročinsko bolezen.
It is estimated that Prevenar could prevent 6-13% of all
Ocenjujejo, da bi cepivo Prevenar lahko preprečilo 6 %-13 % vseh kliničnih izbruhov AOM.
Prevenar will not protect against other Streptococcus pneumoniae serotypes than those included in the vaccine nor other micro-organisms that cause invasive disease or otitis media.
Cepivo Prevenar ne ščiti pred okužbami z drugimi serotipi bakterije Streptococcus pneumoniae kot s tistimi, ki so vključeni v cepivo, niti pred okužbami z drugimi mikroorganizmi, ki povzročajo invazivne okužbe ali vnetje srednjega ušesa.
Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunisation.
Otroci z oslabljeno imunostjo zaradi uporabe imunosupresivnih zdravil, genetske motnje, okužbe s HIV ali drugih vzrokov imajo lahko slabši imunski odziv na aktivno imunizacijo.
Do not inject intravenously.
Ni za intravensko dajanje.
Read all of this leaflet carefully before your child receives this vaccine.
Preden vaš otrok dobi to cepivo natančno preberite to navodilo!
Children aged 12 to 23 months should receive two injections.
Otroci, stari od 12 do 23 mesecev, morajo prejeti dva odmerka cepiva.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Kot pri drugih parenteralnih cepivih je tudi pri cepljenju s cepivom Prevenar potrebno imeti na voljo ustrezno medicinsko oskrbo in nadzor za morebitno redko anafilaktično reakcijo po dajanju cepiva.
Prevenar can be administered simultaneously with other paediatric vaccines in accordance with the recommended immunisation schedules.
Cepljenje s cepivom Prevenar lahko kombiniramo z drugimi cepivi za otroke, skladno z veljavnim programom imunoprofilakse.
The most common side effects (these may occur with more than 1 in 10 doses of the vaccine) are:
Najpogostejši neželeni učinki (lahko se pojavijo pri več kot 1 od 10 odmerkov cepiva) so: