natgillin/translations-raw huggingface dataset:
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.
No consistent increased local or systemic reactions within repeated doses were seen throughout the primary series or with the booster dose, the exceptions being a higher rate of transient tenderness (36.5%) and tenderness that interfered with limb movement (18.5%) were seen with the booster dose.
Izjemi sta večja pogostnost prehodne občutljivosti (36, 5%) in občutljivosti, ki ovira gibanje uda (18, 5%), opaženi po poživitvenem odmerku.
In a post licensure study involving 115 children between 2-5 years of age, tenderness was reported in up to 39.1% of children; in 15.7% of children the tenderness interfered with limb movement.
V raziskavi, ki je bila opravljena po registraciji zdravila in je zajela 115 otrok, starih od 2 do 5 let, so občutljivost zabeležili pri do 39, 1% otrok, pri 15, 7% otrok pa je občutljivost ovirala gibanje uda.
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%.
Redness or induration > 2cm in diameter was reported in 22.6% and 13.9% of children respectively.
13, 9% otrok.
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 šestvalentnii 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%.
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).
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%.
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.
5 Undesirable effects reported in clinical trials or from the post-marketing experience are listed in the following table per body system and per frequency and this is for all age groups.
Navedeni so po lokalizaciji in po pogostnosti in vključujejo otroke vseh starostnih skupin.
The frequency is defined as follows: very common: ≥ 1/ 10, common: ≥ 1/ 100 and < 1/ 10, uncommon: ≥ 1/ 1,000 and < 1/ 100, rare: ≥ 1/ 10,000 and < 1/ 1,000, very rare: ≤ 1/ 10,000.
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 in zelo redki: ≤ 1/ 10. 000.
Very rare:
Bolezni krvi in limfatičnega sistema: zelo redki:
Lymphadenopathy localised to the region of the injection site
limfadenopatija v predelu mesta injiciranja
Hypersensitivity reactions such as anaphylactic/ anaphylactoid reactions including shock, angioneurotic oedema, bronchospasm, dyspnoea, face oedema.
preobčutljivostne reakcije kot je anafilaktična/ anafilaktoidna reakcija, vključno s šokom, angionevrotičnim edemom, bronhospazmom, oteženim dihanjem, edemom obraza
Seizures, including febrile seizures.
krči, vključno z vročinskimi krči
Gastrointestinal disorders:
Bolezni prebavil: zelo pogosti:
Vomiting, diarrhoea, decreased appetite.
bruhanje, driska, zmanjšan apetit
Very rare:
Bolezni kože in podkožja: občasni: zelo redki:
Erythema multiforme.
izpuščaj/ koprivnica multiformni eritem
Very common:
Splošne težave in spremembe na mestu aplikacije: zelo pogosti: pogosti:
Injection site swelling/ induration and erythema > 2.4 cm, tenderness interfering with movement, fever > 39 °C.
reakcije na mestu injiciranja (n. pr. eritem, zatrdlina/ oteklina, bolečina/ občutljivost), telesna temperatura ≥ 38 °C, razdražljivost, jok, zaspanost, nemiren spanec oteklina/ zatrdlina in rdečina na mestu injiciranja > 2, 4 cm, bolečina, ki zmanjša gibljivost okončine, telesna temperatura > 39 °C
Hypotonic hyporesponsive episode, injection site hypersensitivity reactions (eg., dermatitis, pruritus, urticaria).
epizoda hipotonije in zmanjšane odzivnosti, preobčutljivostne reakcije na mestu injiciranja (n. pr. dermatitis, srbenje, koprivnica)
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4).
Apnea pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti) (glejte poglavje 4. 4).
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.
In general, adverse events reported with overdose have also been reported with recommended single doses of Prevenar.
Na splošno velja, da se neželeni učinki po prevelikem odmerjanju ne razlikujejo od tistih, o katerih poročajo po priporočenih enkratnih odmerkih.
Pharmacotherapeutic group: pneumococcal vaccines, ATC code:
Cepiva proti pnevmokoknim infekcijam, oznaka ATC:
Prevenar has also been shown to elicit functional
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.
6 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 immunogenicity of a two-dose primary series in infants plus a booster at about one year of age has been documented in several studies.
6 Imunogenost primarnega zaporedja dveh odmerkov pri dojenčkih in poživitvenega odmerka približno v starosti enega leta so dokumentirali v več študijah.
Most of the data have indicated that smaller proportions of infants achieved antibody concentrations ≥ 0.35 μ g/ mL (the reference antibody concentration recommended by WHO) 1 against serotypes 6B and 23F after two-dose primary series when directly or indirectly compared with three-dose primary series.
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) 1 proti serotipoma 6B in 23F, če to neposredno ali posredno primerjamo s primarnim zaporedjem treh odmerkov.
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.
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.
Consequently, Prevenar should cover between 54% and 84% of isolates from invasive pneumococcal disease (IPD) in European children less than 2 years of age.
Zato velja ocena, da naj bi pri evropskih otrocih, mlajših od 2 let, cepivo Prevenar pokrilo 54% do 84% izoliranih pnevmokokov, ki povzročajo invazivne pnevmokokne bolezni (IPD - invasive pneumococcal disease).
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.
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.
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.
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.
The estimate of vaccine serotype specific efficacy was 94% (95% CI:
Ocena serotipično specifične učinkovitosti cepiva je bila 94% (95 - odstotni interval zaupanja:
81, 99) in the intent-to-treat population and 97% (95% CI:
81, 99) v skupini otrok, ki naj bi jih cepili (intent- to- treat), in 97% (95- odstotni interval zaupanja:
85, 100) in the per protocol (fully immunized) population (40 cases).
85, 100) v skupini otrok, ki so opravili vsa cepljenja skladno s protokolom cepljenja (40 primerov).
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.
In the Kaiser Permanente trial, efficacy was 87.5% (95% CI:
V študiji Kaiser Permanente je bila učinkovitost cepiva Prevenar v preprečevanju pnevmokokne pljučnice, ki jo spremlja bakteriemija, proti serotipom bakterije S. pneumoniae, ki so bili vključeni v cepivo, 87, 5% (95- odstotni interval zaupanja:
1 WHO technical report No 927, 2005; Appendix serological criteria for calculation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.
927, 2005; Appendix serological criteria for calculation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.
7 Effectiveness (no microbiological confirmation of diagnosis was performed) against non-bacteraemic pneumonia was also assessed.
7 Ocenjevali so tudi učinkovitost cepiva proti pljučnici brez bakteriemije, v primerih, ko diagnoza pljučnice ni bila mikrobiološko potrjena.
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 beyond the perihilar area, consolidation, or empyema) was 20.5% (95% CI:
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 zunaj predela ob pljučnem hilusu, konsolidacija ali empiem) 20, 5% (95- odstotni interval zaupanja:
Reductions in pneumonia with abnormal chest radiograph were greatest in the first year of life (32.2%; 95% CI:
Zmanjšanje tveganja za pljučnico z nenormalno rentgensko sliko prsnega koša je bilo največje v prvem letu življenja (32, 2%; 95- odstotni interval zaupanja:
3.3, 52.5) and in the first 2 years of life (23.4%; 95% CI:
3, 3, 52, 5) in v prvih 2 letih življenja (23, 4%; 95- odstotni interval zaupanja:
Bacteria can be responsible for 60-70% of clinical episodes of AOM.
Bakterije utegnejo zakriviti 60% - 70% kliničnih izbruhov AOM.
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.
Theoretically, Prevenar could prevent about 60- 80% of serotypes causing pneumococcal AOM.
Teoretično bi Prevenar lahko preprečil okrog 60% - 80% serotipov, ki povzročajo pnevmokokno AOM.
It is estimated that Prevenar could prevent 6-13% of all clinical episodes of AOM.
Ocenjujejo, da bi cepivo Prevenar lahko preprečilo 6% - 13% vseh kliničnih izbruhov AOM.
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.
The estimate for vaccine efficacy against vaccine-serotype AOM, the primary endpoint of the trial, was 57% (95% CI:
Ocena učinkovitosti cepljenja proti akutnemu vnetju srednjega ušesa, povzročenem s serotipi v cepivu, ki je bila glavno merilo učinkovitosti v študiji, je bila 57% (95- odstotni interval zaupanja:
44, 67) in the per-protocol analysis and 54% (95% CI:
44, 67) v skupini otrok, ki so opravili vsa cepljenja skladno s protokolom cepljenja, in 54% (95- odstotni interval zaupanja:
41, 64) in the intent-to-treat analysis.
41, 64) v skupini otrok, ki naj bi jih cepili (intent- to- treat).
A 33% (95% CI: -1, 80) increase in AOM due to serogroups not included in the vaccine was observed in immunised subjects.
Pri cepljenih otrocih so opazili 33% porast (95- odstotni interval zaupanja: - 1, 80) akutnega vnetja srednjega ušesa, povzročenega s serotipi, ki jih cepivo ni vsebovalo.
However, the overall benefit was a 34% (95% CI:
V celoti gledano je bilo pri cepljenih otrocih statistično za 34% (95- odstotni interval zaupanja:
21, 45) reduction in the incidence of all pneumococcal AOM.
21, 45) manj akutnega vnetja srednjega ušesa, povzročenega s pnevmokoki.
The impact of the vaccine on total number of episodes of otitis media regardless of etiology was a 6% (95% CI: -4, 16) reduction.
Cepivo je zmanjšalo celotno število izbruhov vnetja srednjega ušesa ne glede na etiologijo za 6% (95- odstotni interval zaupanja: - 4, 16).
In this follow-up, vaccine efficacy for frequent OM (defined as at least 3 episodes within 6 months) was 18% (95% CI:
Pri tem spremljanju je bila učinkovitost pri pogostem vnetju srednjega ušesa (ki je bilo definirano kot vsaj 3 izbruhi v 6 mesecih) 18% (95- odstotni interval zaupanja:
1, 32), for chronic otitis media with effusion, 50% (95% CI:
1, 32), pri kroničnem vnetju srednjega ušesa z izcedkom 50% (95- odstotni interval zaupanja:
15, 71), and for tympanostomy tube placement, 39% (95% CI:
15, 71), pri vstavljeni timpanični cevki pa 39% (95- odstotni interval zaupanja:
Children were followed until 3.5 years of age.
Otroke so spremljali, dokler niso bili stari 3, 5 leta.
The impact of the vaccine on total number of episodes of otitis media regardless of etiology was a 7% reduction (95% CI:
Cepivo je zmanjšalo celotno število izbruhov vnetja srednjega ušesa ne glede na etiologijo za 7% (95- odstotni interval zaupanja:
3, 15) in recurrent AOM (defined as 3 episodes in six months or 4 episodes in one year) or a 23% (95% CI:
Pri otrocih, ki so opravili vsa cepljenja skladno s protokolom cepljenja, se je ponovno akutno vnetje srednjega ušesa (ki je bilo definirano kot 3 izbruhi v pol leta ali 4 izbruhi v enem letu) zmanjšalo za 9% (95- odstotni interval zaupanja:
Tympanostomy tube placement was reduced by 24% (95% CI:
Vstavitev timpanične cevke se je zmanjšala za 24% (95- odstotni interval zaupanja:
12, 35) in the per-protocol analysis and by 23% (95% CI:
12, 35) pri otrocih, ki so opravili vsa cepljenja skladno s protokolom cepljenja, in za 23% (95- odstotni interval zaupanja:
11, 34) in the intent-to-treat analysis.
11, 34) pri otrocih, ki so jih cepili.
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.
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.
8 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.
When compared with no vaccination, point estimates for the effectiveness of 2-, 3-, or 4-doses given on an infant schedule were similar:
V primerjavi z necepljenjem so bile točkovne ocene za učinkovitost 2, 3 ali 4 odmerkov, danih po shemi za dojenčke, podobne:
In the USA in the same time frame, there was a
96% (95- odstotni interval zaupanja 88- 99); 95% (95- odstotni interval zaupanja 88- 99); oziroma 100% (95- odstotni interval zaupanja 94- 100).
8 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%.
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%.
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 90 - odstotno 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.
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.
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.
Evaluation of pharmacokinetic properties is not available for vaccines.
Za cepiva ne obstajajo farmakokinetični podatki.
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.
9 In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
0.5 ml suspension for injection in vial (Type I glass) with a grey butyl rubber stopper - pack size of 1 and 10 vials without syringe/ needles.
0, 5 ml suspenzije za injiciranje v viali (steklo tipa I) s sivim butilnim gumijastim zamaškom - pakiranje s po 1 in 10 vial brez brizg in brez igel.
Pack size of 1 vial with syringe and 2 needles (1 for withdrawal, 1 for injection).
Pakiranje s po 1 vialo z 1 brizgo in 2 iglama (1 za odvzem, 1 za injiciranje).
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 morate pred uporabo dobro pretresti, da nastane bela homogena suspenzija, in ga pred aplikacijo dobro pregledati, da ne vsebuje delcev in/ ali ni drugačnega fizikalnega videza.
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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).
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 in 5. 1).
11 Infants aged 2 - 6 months:
Dojenčki od 2. do 6. meseca starosti:
Alternatively, when Prevenar is given as part of a routine infant immunisation programme, a two-dose schedule may be considered.
12 Kadar se cepivo Prevenar daje v okviru rutinskega programa cepljenja dojenčkov, lahko pride v poštev tudi shema z dvema odmerkoma.
12 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).
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.
13 valentnega polisaharidnega cepiva proti pnevmokokom pri otrocih, starih ≥ 24 mesecev s povečanim tveganjem (anemija srpastih celic, asplenija, okužba s HIV, kronične bolezni, imunska kompromitiranost) za invazivno okužbo, povzročeno z bakterijo Streptococcus pneumoniae.
Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Prevenar should receive 23-valent pneumococcal polysaccharide vaccine.
Otroci s povečanim tveganjem, stari ≥ 24 mesecev, morajo dobiti 23- valentno pnevmokokno polisaharidno cepivo kadarkoli je to potrebno, tudi če so bili cepljeni s cepivom Prevenar.