FrancophonIA/ELRC3.0 huggingface dataset:
English: OPA titres are expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 %.
Slovenian: Titri OPA so izraženi kot recipročna vrednost največje razredčitve seruma, ki zmanjša preživetje pnevmokokov za najmanj 50 %.
English: Local reactions and systemic events were solicited daily after each vaccination for 14 days in 6 studies and 7 days in the remaining study.
Slovenian: Poročila o lokalnih reakcijah in sistemskih učinkih so bila po vsakem cepljenju pridobljena dnevno v obdobju 14 dni v 6 kliničnih študijah in v obdobju 7 dni v sedmi klinični študiji.
English: S. pneumoniae is the most frequent cause of CAP, and is estimated to be responsible for approximately 30% of all CAP cases requiring hospitalisation in adults in developed countries.
Slovenian: Najpogostejši vzrok CAP je S. pneumoniae, ki v razvitih državah povzroči približno 30 % vseh primerov CAP, kjer je potrebna hospitalizacija odraslih bolnikov.
English: IRR, also referred to as vaccine preventable disease incidence, is the number of cases of vaccine preventable disease per 100,000 person-years of observation.
Slovenian: IRR, ki ga imenujemo tudi incidenca bolezni, ki jo je mogoče preprečiti s cepljenjem, je število primerov bolezni, ki jo je mogoče preprečiti s cepljenjem, na 100.000 oseb-let opazovanja (PYOperson-years of observation).
English: Invasive Pneumococcal Disease
Slovenian: Invazivna pnevmokokna bolezen
English: S. pneumoniae is one of the most common causes of bacterial AOM worldwide.
Slovenian: S. pneumoniae je eden najpogostejših vzrokov bakterijskega akutnega vnetja srednjega ušesa po vsem svetu.
English: Prevenar 13 Relative to PPSV23, 60-64 Years
Slovenian: Prevenar 13 v primerjavi s PPSV23, 60-64 let
English: Immune responses in Special Populations
Slovenian: Imunski odzivi pri posebnih populacijah
English: In this age group, serotypes 1, 3, 5, 6A, 7F, and 19A account for 15.6% to 59.7% of invasive disease, depending on the country, the time period studied, and the use of Prevenar.
Slovenian: V tej starostni skupini serotipi 1, 3, 5, 6A, 7F in 19A povzročajo od 15,6 % do 59,7 % invazivnih bolezni, odvisno od države, preučevanega časovnega obdobja in uporabe cepiva Prevenar.
English: Different injectable vaccines should always be given at different vaccination sites.
Slovenian: Različna cepiva za injiciranje je treba vedno injicirati na različna mesta.
English: During storage, a white deposit and clear supernatant may be observed.
Slovenian: Med shranjevanjem se lahko pojavita bela usedlina in bister supernatant.
English: Safety in 354 previously unvaccinated children (7 months to 5 years of age) was also assessed.
Slovenian: Varnost je bila ocenjena tudi pri 354 predhodno necepljenih otrocih (starih od 7 mesecev do 5 let).
English: In Table 6, NNV is a measure that quantifies the number of people that need to be vaccinated in order to prevent one clinical CAP case.
Slovenian: V preglednici 6 je NNV merilo števila ljudi, ki jih je treba cepiti, da preprečimo en primer klinične CAP.
English: 19 to 733
Slovenian: 19 do 733
English: The efficacy results from these studies (for invasive pneumococcal disease, pneumonia, and acute otitis media) are presented below (Table 3).
Slovenian: Rezultati učinkovitosti iz teh študij (za invazivno pnevmokokno bolezen, pljučnico in akutno vnetje srednjega ušesa) so predstavljeni spodaj (preglednica 3).
English: For all pivotal clinical trials, a serotype-specific opsonophagocytosis assay (OPA) was used as a surrogate to assess potential efficacy against invasive pneumococcal disease and pneumonia.
Slovenian: Pri vseh ključnih kliničnih preskušanjih je bila serotipno specifična opsonofagocitozna analiza (OPA) uporabljena kot nadomestek za oceno morebitne učinkovitosti proti invazivni pnevmokokni bolezni in pljučnici.
English: oC. Other in-use storage times and conditions are the responsibility of the user.
Slovenian: Za čas shranjevanja in pogoje pred uporabo je odgovoren uporabnik.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet s cepivom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet s cepivom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: 7-valent Prevenar
Slovenian: 7-valentni Prevenar
English: NNV is not a rate but instead indicates the number of cases prevented for a given number of persons vaccinated.
Slovenian: NNV ne izraža stopnje, temveč število primerov, preprečenih pri danem številu cepljenih oseb.
English: Burden of disease
Slovenian: Breme bolezni
English: 2-phenoxyethanol Water for injections
Slovenian: 2-fenoksietanol voda za injekcije
English: The immunisation schedules for Prevenar 13 should be based on official recommendations.
Slovenian: Sheme cepljenja s cepivom Prevenar 13 morajo temeljiti na uradnih priporočilih.
English: The incidence in older, predominantly non-vaccinated children (>5 years) did not change over the duration of the study.
Slovenian: Incidenca pri starejših, večinoma necepljenih otrocih (starejši od 5 let), se v času trajanja študije ni spremenila.
English: 5 to 45
Slovenian: 5 do 45
English: For the 7 common serotypes there were no differences between groups in the proportion of subjects with OPA titres ≥ 1:8.
Slovenian: Za 7 skupnih serotipov niso ugotovili razlik med skupinami, kar se tiče deleža preskušancev s titri OPA ≥ 1:8.
English: Safety was assessed in 7 clinical studies including 91,593 adults ranging in age from 18 to 101 years.
Slovenian: Varnost je bila ocenjena v 7 kliničnih študijah, v katere je bilo vključenih 91.593 odraslih v starosti od 18 do 101 leta.
English: 23 to 2948
Slovenian: 23 do 2.948
English: Corrected for proportion of samples serotyped, missing age, denominator compared with 2009/10, and for the trend in total invasive pneumococcal disease up to 2009/10 (after which no trend correction was applied).
Slovenian: Popravljeno za delež serotipiziranih vzorcev, manjkajočo starost, imenovalec, primerjan z obdobjem 2009/10, in trend skupne IPD do obdobja 2009/10 (pozneje popravek trenda ni bil uporabljen).
English: * 95% CI inflated from a Poisson interval based on over-dispersion of 2.1 seen from modelling of 2000-06 pre-Prevenar all IPD data.
Slovenian: * 95 % IZ, ki izhaja iz Poissonovega intervala na podlagi nadrazpršenosti 2,1, ki so jo opazili pri modeliranju vseh podatkov o IPD iz obdobja 2000-06 pred uporabo cepiva Prevenar.
English: For 6 of the remaining 7 common serotypes, similar rates of NP acquisition were observed in both vaccine groups; for serotype 19F a significant reduction was observed.
Slovenian: Za 6 od preostalih 7 skupnih serotipov so opazili podobno naselitev nosnožrelnega prostora pri obeh cepivih; za serotip 19F pa so opazili pomembno zmanjšanje.
English: The reported incidence of community-acquired pneumonia (CAP) and IPD in Europe varies by country, increases with age from 50 years and is highest in individuals aged ≥ 65 years.
Slovenian: Poročana incidenca zunajbolnišnične pljučnice (CAP - Community-Acquired Pneumonia) in invazivne pnevmokokne bolezni (IPD - Invasive Pneumococcal Disease) se v Evropi razlikuje od države do države, po 50. letu se povečuje s starostjo in je največja pri posameznikih, starih ≥ 65 let.
English: Adverse reactions reported in clinical studies or from the postmarketing experience for all age groups are listed in this section per system organ class, in decreasing order of frequency and seriousness.
Slovenian: Neželeni učinki, o katerih so poročali v kliničnih študijah ali v obdobju trženja (za vse starostne skupine), so v tem poglavju navedeni po organskih sistemih po padajoči pogostnosti in resnosti.
English: Efficacy was demonstrated for the primary and secondary endpoints in the per protocol population (Table 5).
Slovenian: Učinkovitost je bila dokazana za primarni in sekundarna opazovana dogodka v populaciji po protokolu (preglednica 5).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden prejmete to cepivo.
English: 6A 7F 19A The serotype in Prevenar with the lowest percent response rate was 6B in study 006 (87.1 %).
Slovenian: 6A 7F 19A Serotip v cepivu Prevenar z najmanjšim deležem odziva v študiji 006 je bil 6B (87,1 %).
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET S CEPIVOM
English: The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
Slovenian: Uporaba cepiva Prevenar 13 mora temeljiti na podlagi uradnih priporočil, ki upoštevajo tako tveganje invazivne bolezni in pljučnice v različnih starostnih skupinah ter sočasno prisotne bolezni, kot tudi variabilnost epidemiološke razširjenosti serotipov v različnih zemljepisnih predelih.
English: The most commonly reported adverse reactions in children 6 weeks to 5 years of age were vaccination-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali pri otrocih, starih od 6 tednov do 5 let, so bili reakcije na mestu cepljenja, vročina, razdražljivost, zmanjšan apetit in podaljšan ali skrajšan čas spanja.
English: Tell your doctor, pharmacist or nurse if you or your child is taking, has recently taken or might take any other medicines, or has recently received any other vaccine.
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če vi ali vaš otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo ali če ste bili vi ali vaš otrok pred kratkim cepljeni s katerimkoli cepivom.
English: If this applies to you or your child, then the vaccination will be postponed until you or your child is feeling better.
Slovenian: V tem primeru bo zdravnik cepljenje odložil, dokler se vi ali vaš otrok ne boste počutili bolje.
English: It is unknown whether pneumococcal 13-valent conjugate vaccine is excreted in human milk.
Slovenian: Ni znano, ali se 13-valentno pnevmokokno konjugirano cepivo pri človeku izloča v mleko.
English: Your doctor may ask you to give your child paracetamol or other medicines that lower fever before Prevenar 13 is given.
Slovenian: Zdravnik vam bo morda naročil, da svojemu otroku date paracetamol ali druga zdravila za zniževanje vročine, preden bo dobil cepivo Prevenar 13.
English: For the six additional serotypes, these values were compared with the lowest response among all of the seven common serotypes in the Prevenar recipients.
Slovenian: Za šest dodatnih serotipov so te vrednosti primerjali z najmanjšim odzivom med vsemi sedmimi skupnimi serotipi pri preskušancih, ki so prejeli cepivo Prevenar.
English: A post-hoc analysis was used to estimate the following public health outcomes against clinical CAP (as defined in the CAPiTA study, and based on clinical findings regardless of radiologic infiltrate or etiologic confirmation): vaccine efficacy (VE), incidence rate reduction (IRR), and number needed to vaccinate (NNV) (Table 6).
Slovenian: S post-hoc analizo so ocenili naslednje javnozdravstvene izide glede klinične CAP (kot so jo opredelili v študiji CAPiTA in na podlagi kliničnih ugotovitev, ne glede na radiološki infiltrat ali potrditev vzroka): učinkovitost cepiva (UC), zmanjšanje incidence (IRR - incidence rate reduction) in število ljudi, ki jih je treba cepiti (NNV - number needed to vaccinate) (preglednica 6).
English: • has any present or past medical problems after any dose of Prevenar or Prevenar 13 such as an allergic reaction or problems with breathing.
Slovenian: • po predhodnem cepljenju s katerimkoli odmerkom cepiva Prevenar ali Prevenar 13 kakršnekoli zdravstvene težave, na primer alergijsko reakcijo ali težave z dihanjem.
English: Hampshire PO9 2NG United Kingdom
Slovenian: Hampshire PO9 2NG Velika Britanija
English: All serotypes: 73% Vaccine serotypes: 2-dose infant series: 99% Completed schedule:100%
Slovenian: Vsi serotipi: 73 % Serotipi cepiva: shema cepljenja dojenčkov z 2 odmerkoma: 99 % dokončana shema:100 %
English: Bacteraemic pneumonia (approximately 80% of IPD in adults), bacteraemia without a focus, and meningitis are the most common manifestations of IPD in adults.
Slovenian: Pljučnica z bakteriemijo (približno 80 % primerov IPD pri odraslih), bakteriemija brez žarišča in meningitis so najpogostejše pojavne oblike IPD pri odraslih.
English: The efficacy of 7-valent Prevenar was evaluated in two major studies - the Northern California Kaiser Permanente (NCKP) study and the Finnish Otitis Media (FinOM) study.
Slovenian: Učinkovitost 7-valentnega cepiva Prevenar so ovrednotili z dvema večjima kliničnima študijama - s severnokalifornijsko študijo Northern California Kaiser Permanente (NCKP) in finsko študijo vnetja srednjega ušesa (FinOM).
English: Prevenar 13 50-59 Relative to 60-64 Years
Slovenian: Prevenar 13 50-59 let v primerjavi s 60-64 let
English: The first dose was administered at 3 to 6 months after HSCT.
Slovenian: Prvi odmerek so prejeli od 3 do 6 mesecev po HSCT.
English: Five clinical studies were conducted in Europe and the USA evaluating the immunogenicity of Prevenar 13 in different age groups ranging from 18-95 years of age.
Slovenian: V Evropi in ZDA so izvedli 5 kliničnih študij, s katerimi so ocenjevali imunogenost cepiva Prevenar 13 pri različnih starostnih skupinah v starosti od 18 do 95 let.
English: Furthermore, in this study statistically significantly greater OPA GMTs were demonstrated for 10 of the 12 serotypes in common.
Slovenian: Poleg tega so v tej študiji dokazali statistično pomembno večje vrednosti geometričnih sredin titrov (GMT) OPA za 10 izmed 12 skupnih serotipov.
English: While direct cause-and-effect cannot be inferred from observational analyses of this type, these findings suggest that Prevenar plays an important role in reducing the burden of mucosal disease (AOM and pneumonia) in the target population.
Slovenian: Medtem ko iz tovrstnih opazovalnih analiz ne moremo sklepati na neposreden vzrok in posledico, te ugotovitve kažejo, da ima cepivo Prevenar pri ciljni populaciji pomembno vlogo pri zmanjševanju bremena bolezni sluznic (akutno vnetje srednjega ušesa in pljučnica).
English: First episode analysis
Slovenian: Analiza prve epizode
English: The clinical relevance of the antibody levels elicited by Prevenar 13 in these special populations is unknown.
Slovenian: Klinična pomembnost ravni protiteles, ki jih pri teh posebnih populacijah povzroči cepivo Prevenar 13, ni znana.
English: There was no carriage of serotypes 1 and 5 observed.
Slovenian: Nosilstva za serotipa 1 in 5 niso opazili.
English: In children and adolescents aged 6 to 17 years, the incidence of pneumococcal disease is low, however, there is an increased risk of morbidity and mortality in those with underlying comorbidities.
Slovenian: Pri otrocih in mladostnikih, starih od 6 do 17 let, je incidenca pnevmokokne bolezni majhna, vendar pa pri tistih s sočasno prisotnimi boleznimi obstaja povečano tveganje obolevnosti in smrtnosti.
English: All episodes analysis
Slovenian: Analiza vseh epizod
English: Prevenar 13, provides protection against 13 types of Streptococcus pneumoniae bacteria, and replaces Prevenar, which provided protection against 7 types.
Slovenian: Cepivo Prevenar 13 nudi zaščito proti 13 tipom bakterije Streptococcus pneumoniae in nadomešča cepivo Prevenar, ki nudi zaščito proti 7 tipom.
English: What you need to know before you or your child receives Prevenar 13
Slovenian: Kaj morate vedeti, preden boste vi ali vaš otrok prejeli cepivo Prevenar 13
English: Following the widespread use of Prevenar, the incidence of IPD has been consistently and substantially reduced.
Slovenian: Zaradi razširjene uporabe cepiva Prevenar se je incidenca invazivnih pnevmokoknih bolezni dosledno in znatno zmanjšala.
English: Pyrexia (very common in adults aged 18 to 29 years)
Slovenian: pireksija (zelo pogosto pri odraslih, starih od 18 do 29 let)
English: For vaccine serotypes, protection against otitis media is expected to be lower than protection against invasive disease.
Slovenian: Za serotipe, ki jih vsebuje cepivo, pričakujemo, da bo zaščita pred vnetjem srednjega ušesa manjša kot zaščita pred invazivnimi boleznimi.
English: Efficacy study in adults 65 years and older
Slovenian: Študija učinkovitosti pri odraslih, starih 65 let in več
English: For children 1 to 5 years of age previously vaccinated with Prevenar, your doctor or nurse will recommend how many injections of Prevenar 13 are required.
Slovenian: Za otroke, stare od 1 do 5 let, ki so bili predhodno cepljeni s cepivom Prevenar, vam bosta zdravnik ali medicinska sestra priporočila, koliko odmerkov cepiva Prevenar 13 je potrebnih.
English: Overall, the frequency categories were similar for all age groups, with the exception of vomiting which was very common ( 1/10) in adults aged 18 to 49 years and common ( 1/100 to < 1/10) in all other age groups, and pyrexia was very common in adults aged 18 to 29 years and common in all other age groups.
Slovenian: V celoti so bile kategorije pogostnosti podobne za vse starostne skupine, razen pri bruhanju, ki je bilo zelo pogosto (≥ 1/10) pri odraslih, starih od 18 do 49 let, in pogosto (≥ 1/100 do < 1/10) v vseh drugih starostnih skupinah; pireksija pa je bila zelo pogosta pri odraslih, starih od 18 do 29 let, in pogosta v vseh drugih starostnih skupinah.
English: Reductions were 53% (167 to 79 cases) (p<0.001) for CAP cases with pleural effusion and 63% (64 to 24 cases) (p<0.001) for microbiologically confirmed pneumococcal CAP cases.
Slovenian: Zmanjšanje je bilo 53 % (s 167 na 79 primerov) (p < 0,001) za primere CAP s plevralnim izlivom in 63 % (s 64 na 24 primerov) (p < 0,001) za mikrobiološko potrjene primere CAP zaradi pnevmokokov.
English: Read all of this leaflet carefully before you or your child receives this vaccine because it contains important information for you.
Slovenian: Preden boste vi ali vaš otrok prejeli cepivo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Vaccines were administered at 1 month intervals.
Slovenian: Odmerke cepiva so prejeli v presledkih po 1 mesec.
English: (2006) 2, 4, + 13 months
Slovenian: (2006) 2., 4., + 13. mesec
English: 1 dose (0.5 ml) contains:
Slovenian: En odmerek (0,5 ml) vsebuje:
English: However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Slovenian: Blažja okužba, na primer prehlad, ni razlog za odložitev cepljenja.
English: 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.
Slovenian: Po primarni imunizaciji je imelo 95,6 % preskušancev ravni protiteles vsaj 0,35 μg/ml za vseh sedem serotipov v cepivu Prevenar.
English: 5 to 37
Slovenian: 5 do 37
English: What Prevenar 13 is and what it is used for
Slovenian: Kaj je cepivo Prevenar 13 in za kaj ga uporabljamo
English: 4 x 0.5 ml doses
Slovenian: 4 x 0,5 ml odmerek
English: In the same study another group of adults aged 50-59 years and another group of adults aged 18-49 years received a single dose of Prevenar 13.
Slovenian: V isti študiji sta druga skupina odraslih v starosti od 50 do 59 let in tretja skupina odraslih v starosti od 18 do 49 let prejeli en sam odmerek cepiva Prevenar 13.
English: As with concomitant administration with trivalent vaccines, immune responses to some pneumococcal serotypes were lower when both vaccines were given concomitantly.
Slovenian: Kot pri sočasni uporabi s trivalentnimi cepivi so bili imunski odzivi na nekatere pnevmokokne serotipe slabši ob sočasnem dajanju obeh cepiv.
English: Arthralgia; myalgia
Slovenian: artralgija, mialgija
English: Table 5: Vaccine efficacy (VE) for the primary and secondary endpoints of the CAPiTA study (per protocol population)
Slovenian: Preglednica 5: Učinkovitost cepiva (UC) za primarni in sekundarna opazovana dogodka v študiji CAPiTA (populacija po protokolu)
English: Prevenar 13 immunogenicity clinical studies in infants, children and adolescents
Slovenian: Klinične študije imunogenosti cepiva Prevenar 13 pri dojenčkih, otrocih in mladostnikih
English: Prevenar 13 elicited functional antibodies to all 13 vaccine serotypes in studies 004 and 006.
Slovenian: Cepivo Prevenar 13 je izzvalo tvorbo funkcionalnih protiteles proti vsem 13 serotipom cepiva v študijah 004 in 006.
English: Adults should receive one injection.
Slovenian: Odrasli morajo prejeti en odmerek cepiva.
English: * Patients with at least 2 of the following: Cough; purulent sputum, temperature >38°C or <36.1°C; pneumonia (auscultatory findings); leukocytosis; C-reactive protein value >3 times the upper limit of normal; hypoxemia with a partial oxygen pressure <60 mm Hg while breathing room air.
Slovenian: * Bolniki z vsaj 2 od naslednjega: kašelj, gnojen sputum, telesna temperatura > 38 °C ali < 36,1 °C; pljučnica (ugotovljena z avskultacijo); levkocitoza; vrednost C-reaktivnega proteina > 3-kratnik zgornje meje normale; hipoksemija s parcialnim tlakom kisika < 60 mmHg pri dihanju sobnega zraka.
English: Children (12-59 months) completely immunised with Prevenar (7-valent)
Slovenian: Otroci (12-59 mesecev), ki so bili popolnoma imunizirani s cepivom Prevenar (7-valentnim)
English: Prevenar 13 was administered to 48,806 adults; 2,616 (5.4%) aged 50 to 64 years, and 45,291 (92.8%) aged 65 years and older.
Slovenian: Cepivo Prevenar 13 so dali 48.806 odraslim; 2.616 (5,4 %), starim od 50 do 64 let, in 45.291 (92,8 %), starim 65 let in več.
English: The most common adverse events in children and adolescents 6 to 17 years of age were:
Slovenian: Najpogostejši neželeni učinki pri otrocih in mladostnikih, starih od 6 do 17 let, so bili:
English: Prevenar 13 should not be given:
Slovenian: Cepiva Prevenar 13 se ne sme dati:
English: Vaccine efficacy (95% CI) (1-sided p-value)
Slovenian: Učinkovitost cepiva v % (95 % IZ) (1-stranska vrednost p)
English: Excipients with known effect For the full list of excipients, see section 6.1.
Slovenian: Pomožne snovi z znanim učinkom Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Between 11 and 15 months of age, your child will receive a fourth injection (booster).
Slovenian: Pri starosti od 11 do 15 mesecev bo otrok prejel četrti odmerek (obnovitveni odmerek).
English: Subcutaneous administration of Prevenar 13 was evaluated in a non-comparative study in 185 healthy Japanese infants and children who received 4 doses at 2, 4, 6 and 12-15 months of age.
Slovenian: Subkutano cepljenje s cepivom Prevenar 13 so ocenjevali v neprimerjalni študiji pri 185 zdravih japonskih dojenčkih in otrocih, ki so prejeli po 4 odmerke pri 2, 4, 6 in 12-15 mesecih starosti.
English: Safety and immunogenicity data for Prevenar 13 are not available for individuals in other specific immuno-compromised groups (e.g., malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis.
Slovenian: Podatki o varnosti in imunogenosti cepiva Prevenar 13 pri posameznikih iz drugih specifičnih skupin imunsko oslabljenih posameznikov (npr. z malignimi boleznimi ali nefrotskim sindromom) niso na voljo, zato je treba potrebo po cepljenju pretehtati individualno.
English: Disease reduction, % 95% CI
Slovenian: Zmanjšanje bolezni, % 95 % IZ
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: 5 to 64 years of age
Slovenian: Stari od 5 do 64 let