natgillin/translations-raw huggingface dataset:
Pyrexia (very common in adults aged 18 to 29 years)
pireksija (zelo pogosto pri odraslih, starih od 18 do 29 let)
For vaccine serotypes, protection against otitis media is expected to be lower than protection against invasive disease.
Za serotipe, ki jih vsebuje cepivo, pričakujemo, da bo zaščita pred vnetjem srednjega ušesa manjša kot zaščita pred invazivnimi boleznimi.
Efficacy study in adults 65 years and older
Študija učinkovitosti pri odraslih, starih 65 let in več
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.
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.
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.
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.
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.
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.
Read all of this leaflet carefully before you or your child receives this vaccine because it contains important information for you.
Preden boste vi ali vaš otrok prejeli cepivo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Vaccines were administered at 1 month intervals.
Odmerke cepiva so prejeli v presledkih po 1 mesec.
(2006) 2, 4, + 13 months
(2006) 2., 4., + 13. mesec
1 dose (0.5 ml) contains:
En odmerek (0,5 ml) vsebuje:
However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Blažja okužba, na primer prehlad, ni razlog za odložitev cepljenja.
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 imelo 95,6 % preskušancev ravni protiteles vsaj 0,35 μg/ml za vseh sedem serotipov v cepivu Prevenar.
What Prevenar 13 is and what it is used for
Kaj je cepivo Prevenar 13 in za kaj ga uporabljamo
4 x 0.5 ml doses
4 x 0,5 ml odmerek
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.
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.
As with concomitant administration with trivalent vaccines, immune responses to some pneumococcal serotypes were lower when both vaccines were given concomitantly.
Kot pri sočasni uporabi s trivalentnimi cepivi so bili imunski odzivi na nekatere pnevmokokne serotipe slabši ob sočasnem dajanju obeh cepiv.
Arthralgia; myalgia
artralgija, mialgija
Table 5: Vaccine efficacy (VE) for the primary and secondary endpoints of the CAPiTA study (per protocol population)
Preglednica 5: Učinkovitost cepiva (UC) za primarni in sekundarna opazovana dogodka v študiji CAPiTA (populacija po protokolu)
Prevenar 13 immunogenicity clinical studies in infants, children and adolescents
Klinične študije imunogenosti cepiva Prevenar 13 pri dojenčkih, otrocih in mladostnikih
Prevenar 13 elicited functional antibodies to all 13 vaccine serotypes in studies 004 and 006.
Cepivo Prevenar 13 je izzvalo tvorbo funkcionalnih protiteles proti vsem 13 serotipom cepiva v študijah 004 in 006.
Adults should receive one injection.
Odrasli morajo prejeti en odmerek cepiva.
* 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.
* 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.
Children (12-59 months) completely immunised with Prevenar (7-valent)
Otroci (12-59 mesecev), ki so bili popolnoma imunizirani s cepivom Prevenar (7-valentnim)
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.
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.
The most common adverse events in children and adolescents 6 to 17 years of age were:
Najpogostejši neželeni učinki pri otrocih in mladostnikih, starih od 6 do 17 let, so bili:
Prevenar 13 should not be given:
Cepiva Prevenar 13 se ne sme dati:
Vaccine efficacy (95% CI) (1-sided p-value)
Učinkovitost cepiva v % (95 % IZ) (1-stranska vrednost p)
Excipients with known effect For the full list of excipients, see section 6.1.
Pomožne snovi z znanim učinkom Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Between 11 and 15 months of age, your child will receive a fourth injection (booster).
Pri starosti od 11 do 15 mesecev bo otrok prejel četrti odmerek (obnovitveni odmerek).
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.
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.
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.
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.
Disease reduction, % 95% CI
Zmanjšanje bolezni, % 95 % IZ
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
5 to 64 years of age
Stari od 5 do 64 let
This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent) (see section 5.1).
Tak odmerek cepiva Prevenar 13 je treba dati najmanj 8 tednov po zadnjem odmerku cepiva Prevenar (7-valentnega) (glejte poglavje 5.1).
Adults 18 to 49 years of age
Odrasli, stari od 18 do 49 let
Since the introduction of 7-valent Prevenar in 2000, pneumococcal disease surveillance data have not shown that the immunity elicited by Prevenar in infancy has waned over time.
Od uvedbe 7-valentnega cepiva Prevenar v letu 2000 podatki iz spremljanja poteka pnevmokokne bolezni niso pokazali, da bi imunost, povzročena s cepivom Prevenar v otroštvu, s časom pojemala.
In the second year after the introduction of Prevenar 13 the total number of CAP cases due to the 6 additional vaccine serotypes in Prevenar 13 was reduced from 27 to 7 isolates (74%).
V drugem letu po uvedbi cepiva Prevenar 13 se je skupno število primerov CAP zaradi 6 dodatnih serotipov v cepivu Prevenar 13 zmanjšalo s 27 na 7 izolatov (74 %).
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO CEPIVA
The duration of protective efficacy against a first episode of VT pneumococcal CAP, NB/NI VT pneumococcal CAP, and VT-IPD extended throughout the 4-year study.
Učinkovitost zaščite proti prvi epizodi VT-pnevmokokne CAP, NB/NI VT-pnevmokokne CAP in VT-IPD je trajala ves čas 4-letne študije.
The proportions of functional antibody responders (OPA titres ≥ 1:8) to serotypes 1, 3 and 5 were high.
Deleži bolnikov, ki so se odzvali s tvorbo delujočih protiteles (titri OPA ≥ 1:8) za serotipe 1, 3 in 5, so bili veliki.
• Periodic Safety Update Reports
• Redno posodobljena poročila o varnosti cepiva (PSUR)
A third dose is recommended in the second year of life.
Tretji odmerek prejmejo v drugem letu življenja.
Prevenar 13 must not be mixed with any other vaccines in the same syringe.
Cepiva Prevenar 13 ne smete mešati z drugimi cepivi v isti injekcijski brizgi.
Blood and lymphatic system disorders: Lymphadenopathy (localised to the region of the vaccination-site)
Bolezni krvi in limfatičnega sistema: limfadenopatija (omejena na predel mesta cepljenja)
Talk to your doctor, pharmacist, or nurse before the vaccination if you or your child:
Pred cepljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če ste imeli vi ali vaš otrok:
Immune responses as measured by IgG GMCs were assessed in 168-211 evaluable subjects approximately 1 month after vaccination.
Imunski odziv so ocenili z IgG GMC pri 168-211 ocenljivih preskušancih približno 1 mesec po cepljenju.
Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunisation.
Pri posameznikih z oslabljeno imunsko odzivnostjo zaradi uporabe imunosupresivnih zdravil, genetske motnje, okužbe z virusom HIV ali drugih vzrokov, je imunski odziv na aktivno imunizacijo lahko zmanjšan.
The active substances are polysaccharide CRM197 conjugates consisting of:
Učinkovine so polisaharidi, konjugirani na CRM197, sestavljeni iz:
The vaccine should be given by intramuscular injection.
Cepivo je treba injicirati intramuskularno.
It is unknown whether immunological memory to all serotypes is induced in pre-term infants.
Ni znano, ali pri nedonošenčkih pride do indukcije imunološkega spomina za vse serotipe.
• Severe allergic reaction including shock (cardiovascular collapse); angioedema (swelling of lips, face or throat)
• huda alergijska reakcija, vključno s šokom (kardiovaskularni kolaps); angioedem (otekanje ustnic, obraza ali žrela)
Once opened, the product may be stored for a maximum of 28 days at 2-8
Po odprtju lahko izdelek shranjujete največ 28 dni pri temperaturi med 2 °C in 8 °C.
• Allergic (hypersensitivity) reaction, including swelling of the face and/or lips, difficulty in breathing
• alergijska (preobčutljivostna) reakcija, vključno z oteklino obraza in/ali ustnic, težko dihanje
What Prevenar 13 is and what it is used for What you need to know before you or your child receives Prevenar 13 How Prevenar 13 is given
Kaj je cepivo Prevenar 13 in za kaj ga uporabljamo Kaj morate vedeti, preden boste vi ali vaš otrok prejeli cepivo Prevenar 13 Kako se cepivo Prevenar 13 uporablja Možni neželeni učinki
OPA geometric mean titers (GMTs) measured 1-month after each vaccination were calculated.
Izračunane so bile geometrične sredine titrov (GMT) OPA, izmerjene 1 mesec po vsakem cepljenju.
NCKP: Clinical pneumonia with abnormal chest X-ray
NCKP: klinična pljučnica z nenormalnim rentgenogramom prsnega koša
Children 5 to 17 years of age may receive a single dose of Prevenar 13 if they have been previously vaccinated with one or more doses of Prevenar.
Otroci, stari od 5 do 17 let, lahko prejmejo enkratni odmerek cepiva Prevenar 13, če so bili predhodno cepljeni z enim ali več odmerki cepiva Prevenar.
Correspondingly, OPA GMTs were similar in both groups, except for serotype 3, which was lower, and serotype 18C, which was higher, in the group that received Prevenar 13 with 2-PE.
Ustrezno so bile ravni OPA GMT pri obeh skupinah podobne, razen za serotip 3, kjer je bila raven nižja, in serotip 18C, kjer je bila raven višja pri skupini, ki je prejemala Prevenar 13 s konzervansom 2-PE.
In general, adverse events reported with overdose are consistent with those that have been reported with doses given in the recommended paediatric schedules of Prevenar 13.
Na splošno so bili neželeni učinki, o katerih so poročali pri prevelikem odmerjanju, enaki tistim, o katerih so poročali pri uporabi odmerkov v okviru priporočenih pediatričnih shem cepiva Prevenar 13.
Immune system disorders: Anaphylactic/anaphylactoid reaction including shock; angioedema
Bolezni imunskega sistema: anafilaktična/anafilaktoidna reakcija, vključno s šokom; angioedem
18-49 Years N=836-866
18-49 let n = 836-866
Limited data have demonstrated that Prevenar 7-valent (three-dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups (see section 5.1).
Omejeni podatki kažejo, da 7-valentno cepivo Prevenar (osnovno cepljenje s tremi odmerki) pri dojenčkih s srpastocelično anemijo sproži sprejemljiv imunski odziv s podobnim varnostnim profilom kot so ga opazili pri skupinah, ki nimajo velikega tveganja (glejte poglavje 5.1).
A Poisson regression model with random effects was used to calculate VE.
Za izračun UC so uporabili Poissonov model regresije z naključnimi učinki.
In an open-label study in 592 healthy children and adolescents including those with asthma (17.4%) who may be predisposed to pneumococcal infection, Prevenar 13 elicited immune responses to all 13 serotypes.
V odprti študiji, v kateri je sodelovalo 592 zdravih otrok in mladostnikov, vključno s tistimi z astmo (17,4 %), za katere velja, da so nagnjeni k pnevmokoknim okužbam, je cepivo Prevenar 13 izzvalo imunski odziv na vseh 13 serotipov.
Approximately one month after the toddler dose, the proportion of subjects in each group achieving this same antibody concentration threshold was >97%, except for serotype 3 (71% in preterm infants and 79% in term infants).
Približno en mesec po pediatričnem odmerku je bil delež preskušancev v vsaki skupini, ki je dosegla enak prag za koncentracijo protiteles, > 97 %, razen za serotip 3 (71 % pri nedonošenčkih in 79 % pri donošenčkih).
Recommended schedule
Priporočena shema
The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine into your arm or your child's arm or leg muscle.
Priporočeni odmerek cepiva (0,5 ml) vam bo v mišico na roki oziroma bo otroku v mišico na roki ali nogi injiciral zdravnik ali medicinska sestra.
A trend to lower frequency of adverse reactions was associated with greater age; adults > 65 years of age (regardless of prior pneumococcal vaccination status) reported fewer adverse reactions than younger adults, with adverse reactions generally most common in the youngest adults, 18 to 29 years of age.
Trend zmanjševanja pogostnosti neželenih učinkov je bil povezan z večjo starostjo; pri odraslih, starejših od 65 let (ne glede na to, ali so bili predhodno že cepljeni proti pnevmokokom), so poročali o manj neželenih učinkih kot pri mlajših odraslih, neželeni učinki pa so se na splošno najpogosteje pojavljali pri najmlajših odraslih, starih od 18 do 29 let.
As recommended by the World Health Organization (WHO) the assessment of potential efficacy against IPD in infants and young children has been based on a comparison of immune responses to the seven common serotypes shared between Prevenar 13 and Prevenar, for which protective efficacy has been proven (for Prevenar (7-valent) efficacy in infants and children, see below).
Po priporočilih Svetovne zdravstvene organizacije (SZO) ocena možne učinkovitosti zaščite pred IPD pri dojenčkih in majhnih otrocih temelji na primerjavi imunskih odzivov na sedem serotipov, ki so skupni cepivoma Prevenar 13 in Prevenar, za katere je bila dokazana učinkovitost zaščite (za učinkovitost cepiva Prevenar (7-valentnega) pri dojenčkih in otrocih glejte spodaj).
This will help to lower some of the side effects of Prevenar 13.
To pomaga ublažiti nekatere neželene učinke cepiva Prevenar 13.
Severe vaccination-site pain/tenderness and severe limitation of arm movement was very common in adults 18 to 39 years and common in all other age groups.
Huda bolečina/občutljivost na mestu cepljenja in močno omejena sposobnost gibanja roke je bila zelo pogosta pri odraslih, starih od 18 do 39 let, in pogosta v vseh drugih starostnih skupinah.
Using the screening method, serotype-specific effectiveness estimates for 2 doses under the age of 1 year in the UK were 66 % (-29, 91 %) and 100 % (25, 100 %) for serotype 6B and 23F, respectively.
Z metodo presejanja so učinkovitost, specifično za serotip, za 2 odmerka do starosti 1 leta v Veliki Britaniji ocenili na 66 % (-29, 91 %) oziroma 100 % (25, 100 %) za serotip 6B oziroma 23F.
Efficacy against vaccine-type (VT) pneumococcal CAP and IPD was assessed in a large-scale randomised double-blind, placebo-controlled study (Community-Acquired Pneumonia Immunization Trial in Adults-CAPiTA) in the Netherlands.
Učinkovitost proti CAP in IPD, povzročenima z vrsto, prisotno v cepivu (VT - vaccine-type), so ocenili v obsežni, randomizirani, dvojno slepi s placebom nadzorovani študiji (CAPiTA - CommunityAcquired Pneumonia Immunization Trial in Adults) na Nizozemskem.
Safety was evaluated in 592 children (294 children aged 5 to 10 years previously immunised with at least one dose of Prevenar and 298 children aged 10 to 17 years who had not received a pneumococcal vaccine).
Varnost je bila ocenjena pri 592 otrocih (294 otrok, starih od 5 do 10 let, ki so bili predhodno cepljeni z vsaj enim odmerkom cepiva Prevenar in 298 otrok, starih od 10 do 17 let, ki niso prejeli pnevmokoknega cepiva).
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to diphtheria toxoid.
Preobčutljivost na učinkovine, katerokoli pomožno snov, navedeno v poglavju 6.1, ali davični toksoid.
Additional Prevenar (7-valent) immunogenicity data: children with sickle cell disease The immunogenicity of Prevenar has been investigated in an open-label, multicentre study in 49 infants with sickle cell disease.
Dodatni podatki o imunogenosti cepiva Prevenar (7-valentnega): otroci s srpastocelično anemijo Imunogenost cepiva Prevenar so preučevali v odprti multicentrični študiji pri 49 dojenčkih s srpastocelično anemijo.
After the booster dose, all vaccine serotypes including 6B and 23F had immune responses consistent with adequate priming with a two-dose primary series.
Po obnovitvenem odmerku so imeli vsi serotipi cepiva, tudi 6B in 23F, imunske odzive skladne z ustreznim osnovnim cepljenjem z dvema odmerkoma.
In all infant studies, Prevenar 13 was co-administered with routine paediatric vaccines (see section 4.5).
V vseh študijah pri dojenčkih so dojenčki cepivo Prevenar 13 prejeli skupaj z rutinskimi otroškimi cepivi (glejte poglavje 4.5).
At the end of this period Prevenar 13 should be used or discarded.
Po preteku navedenega časa je treba cepivo Prevenar 13 uporabiti ali zavreči.
Skin and subcutaneous tissue disorders: Erythema multiforme
Bolezni kože in podkožja: multiformni eritem
Functional antibody titers (OPA titers) were not measured in this study.
V tej študiji niso merili funkcionalnih titrov protiteles (titrov OPA).
For 9 serotypes, the OPA titers were shown to be statistically significantly greater in Prevenar 13 recipients.
Za 9 serotipov so, kar zadeva titre OPA, pokazali, da so bili statistično pomembno večji pri prejemnikih cepiva Prevenar 13.
The protective efficacy of Prevenar 13 against IPD has not been studied.
Učinkovitosti cepiva Prevenar 13 za zaščito pred IPD niso preučevali.
Prevenar 13 will only protect against ear infections in children caused by the types of Streptococcus pneumoniae for which the vaccine has been developed.
Cepivo Prevenar 13 lahko otroke ščiti le pred okužbami ušes, ki jih povzročajo tipi bakterije Streptococcus pneumoniae, za katere je bilo cepivo razvito.
There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women.
Podatkov o uporabi 13-valentnega pnevmokoknega konjugiranega cepiva pri nosečnicah ni.
Individuals with a blood-forming stem cell transplant may receive three injections, with the first given at 3 to 6 months after the transplant and with an interval of at least 1 month between doses.
Posamezniki s presadkom krvotvornih matičnih celic lahko prejmejo tri odmerke cepiva, pri čemer se prvo cepljenje opravi od 3 do 6 mesecev po presaditvi, med odmerki pa mora miniti vsaj en mesec.
Immune responses were assessed in 259-270 evaluable subjects approximately 1 month after each dose of vaccine.
Imunski odziv so ocenili pri 259-270 ocenljivih preskušancih približno 1 mesec po vsakem odmerku cepiva.
However, 3 (serotypes 1, 5 and 6A) of the 6 additional serotypes showed lower IgG GMC and OPA GMT when compared with children who had received at least one previous vaccination with
Vendar pa je pri 3 (serotipi 1, 5 in 6A) izmed 6 dodatnih serotipov prišlo do nižje ravni IgG GMC in OPA GMT v primerjavi z otroki, pri katerih je bilo opravljeno najmanj eno predhodno cepljenje s cepivom Prevenar 13.
GMT GMR (95% CI)
GMT GMR (95 % IZ)
Studies of Prevenar 13 not containing the preservative 2-PE
Študije cepiva Prevenar 13, ki ne vsebuje konzervansa 2-PE
Vaccine serotypes: 98% All serotypes: 77%
Serotipi cepiva: 98 % Vsi serotipi: 77 %
In the study 162 subjects had received one prior dose of 23-valent pneumococcal polysaccharide vaccine, 143 subjects 2 prior doses and 26 subjects more than 2 prior doses of 23-valent polysaccharide vaccine.
V študiji je 162 oseb prejelo en predhoden odmerek 23-valentnega pnevmokoknega polisaharidnega cepiva, 143 oseb dva predhodna odmerka in 26 oseb več kot dva predhodna odmerka 23-valentnega polisaharidnega cepiva.
Unvaccinated infants, children, and adolescents over 7 months of age
Necepljeni dojenčki, otroci in mladostniki, starejši od 7 mesecev
IRR is calculated as the incidence in the placebo group minus the incidence in the vaccine group, and was mathematically equivalent to VE × the incidence in the placebo group.
IRR so izračunali kot incidenco v skupini s placebom, od katere so odšteli incidenco v skupini s cepivom, in je matematično enakovredna UC, pomnoženi z incidenco v skupini s placebom.
In clinical studies, Prevenar 13 elicited an immune response to all thirteen serotypes included in the vaccine.
V kliničnih študijah je cepivo Prevenar 13 izzvalo imunski odziv na vseh trinajst serotipov, ki so vključeni v cepivo.
The need for revaccination with a subsequent dose of Prevenar 13 has not been established.
Potreba po ponovnem cepljenju z naslednjim odmerkom cepiva Prevenar 13 ni bila dokazana.
Vaccine serotypes: Two doses under age 1: 85%
Serotipi cepiva: dva odmerka pred dopolnjeno starostjo 1 leta: 85 %
Each study included healthy adults and immuno-competent adults with stable underlying conditions known to predispose individuals to pneumococcal infection (i.e., chronic cardiovascular disease, chronic pulmonary disease including asthma, renal disorders and diabetes mellitus, chronic liver disease including alcoholic liver disease), and adults with risk factors such as smoking and alcohol abuse.
V vsaki študiji so sodelovali zdravi odrasli in imunokompetentni odrasli s stabilnimi osnovnimi boleznimi, za katere je znano, da pri posameznikih povzročijo nagnjenost k pnevmokokni okužbi (npr. kronična srčnožilna bolezen, kronična pljučna bolezen, vključno z astmo, bolezni ledvic in sladkorna bolezen, kronična bolezen jeter, vključno z alkoholno boleznijo jeter), in odrasli z dejavniki tveganja, kot sta na primer kajenje in zloraba alkohola.
Concomitant use with other vaccines has not been investigated.
Sočasne uporabe z drugimi cepivi niso raziskali.
Prevenar 13 is for intramuscular use only.
Cepivo Prevenar 13 je namenjeno samo za intramuskularno uporabo.