FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.2 Posology and method of administration {To be completed nationally}.
Slovenian: 4.2 Odmerjanje in način uporabe {Izpolni država članica}.
English: {PRODUCT NAME} 5 mg chewable tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Slovenian: NAVODILO ZA UPORABO {(Lastniško) ime} 5 mg žvečljive tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
English: 4.3 Contraindications {To be completed nationally}.
Slovenian: 4.3 Kontraindikacije {Izpolni država članica}.
English: Blister packs containing 30 chewable tablets.
Slovenian: Pretisni omoti s 30 žvečljivimi tabletami.
English: Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and patients should be re-evaluated on a regular basis to assess progress.
Slovenian: Pediatrične bolnike smejo zdraviti samo zdravniki, ki imajo izkušnje z zdravljenjem pediatrične hiperlipidemije.
English: The mean achieved LDL-C value was 3.38 mmol/l (range: 1.81-6.26 mmol/l) in the atorvastatin group compared to 5.91 mmol/l (range: 3.93-9.96 mmol/l) in the placebo group during the 26week double-blind phase.
Slovenian: Atorvastatin je med 26tedensko dvojno slepo fazo pomembno zmanjšal plazemsko koncentracijo celotnega holesterola, holesterola LDL, trigliceridov in apolipoproteina B. Med 26-tedensko dvojno slepo fazo je bila povprečna dosežena vrednost holesterola LDL v skupini z atorvastatinom 3,38 mmol/l (razpon: 1,81-6,26 mmol/l) in 5,91 mmol/l (razpon: 3,93-9,96 mmol/l) v skupini s placebom.
English: NAME OF THE MEDICINAL PRODUCT {PRODUCT NAME} 5 mg chewable tablets Atorvastatin
Slovenian: IME ZDRAVILA {(Lastniško) ime} 5 mg žvečljive tablete atorvastatin
English: 6.4 Special precautions for storage {To be completed nationally}.
Slovenian: 6.4 Posebna navodila za shranjevanje {Izpolni država članica}.
English: 5.3 Preclinical safety data
Slovenian: 5.3 Predklinični podatki o varnosti {Izpolni država članica}.
English: {PRODUCT NAME} are available in blister packs containing 30 chewable tablets.
Slovenian: Zdravilo je na voljo v naslednjih pakiranjih: škatla s 30 žvečljivimi tabletami v pretisnem omotu.
English: LIST OF EXCIPIENTS Contains aspartame.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: aspartam.
English: Consistent decreases in LDL-C and TC were observed over the range of atorvastatin and o-hydroxyatorvastatin exposures.
Slovenian: V razponu izpostavljenosti atorvastatinu in o-hidroksiatorvastatinu so ugotovili dosledna znižanja holesterola LDL in trigliceridov.
English: Atorvastatin significantly decreased plasma levels of totalC, LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
Slovenian: Povprečne vrednosti holesterola LDL, trigliceridov, holesterola VLDL in apolipoproteina B so se pri vseh preiskovancih zmanjšale do 2. tedna.
English: Paediatric use
Slovenian: peroralna uporaba
English: NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] {PRODUCT NAME} 5 mg chewable tablet
Slovenian: IME ZDRAVILA [Glejte Dodatek I - Izpolni država članica] {(Lastniško) ime} 5 mg žvečljiva tableta
English: Common: Abdominal pain
Slovenian: Pogosti: bolečine v trebuhu
English: How to take {PRODUCT NAME} 4.
Slovenian: Kako jemati zdravilo X 4.
English: Each tablet contains 5 mg of atorvastatin as atorvastatin calcium trihydrate.
Slovenian: Ena tableta vsebuje 5 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
English: NAME OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally] {Name}
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Izpolni država članica] {ime}
English: Before you take {PRODUCT NAME} 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo X 3.
English: The initial dose of atorvastatin was 5 mg daily of a chewable tablet in Cohort A and 10 mg daily of a tablet formulation in Cohort B. The atorvastatin dose was permitted to be doubled if a subject had not attained target LDL-C of <3.35 mmol/L at Week 4 and if atorvastatin was well tolerated.
Slovenian: Odmerek atorvastatina je bilo dovoljeno podvojiti, če preiskovanec 4. teden ni dosegel ciljne vrednosti holesterola LDL < 3,35 mmol/l, in če je atorvastatin dobro prenašal.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 5 mg atorvastatin (as calcium salt trihydrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena žvečljiva tableta vsebuje 5 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
English: {PRODUCT NAME} tablets can be chewed or should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food.
Slovenian: Tablete {(Lastniško) ime} je treba prežvečiti ali jih pogoltniti cele z nekaj vode.
English: Pediatric use should only be carried out by specialists.
Slovenian: Otroke mora zdraviti specialist.
English: Hydroxypropyl cellulose
Slovenian: Hiperholesterolemija
English: An 8-week, open-label study to evaluate pharmacokinetics, pharmacodynamics, and safety and tolerability of atorvastatin was conducted in children and adolescents with genetically confirmed heterozygous familial hypercholesterolemia and baseline LDL-C 4 mmol/L.
Slovenian: Pri otrocih in mladostnikih z genetsko potrjeno heterozigotno familiarno hiperholesterolemijo in izhodiščnim holesterolom LDL  4 mmol/l je bila opravljena 8-tedenska odprta študija za oceno farmakokinetike, farmakodinamike ter varnosti in prenašanja atorvastatina.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
Slovenian: DOPOLNILA, KI JIH JE POTREBNO VKLJUČITI V RELEVANTNA POGLAVJA NAVODILA ZA UPORABO
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu lahko pozneje posodobijo pristojni organi države članice v sodelovanju z referenčno državo članico, če je to primerno, v skladu s postopki, navedenimi v poglavju 4 naslova III Direktive 2001/83/ES.
English: These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Slovenian: Te spremembe ustreznih poglavij informacij o zdravilu so rezultat napotitvenega postopka.
English: What you need to know before you use <product>
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila>
English: No data from clinical studies are available to demonstrate that the use of <product> can prevent pneumonia.
Slovenian: Ni podatkov iz kliničnih študij, ki kažejo, da lahko uporaba zdravila <ime zdravila> prepreči pljučnico.
English: [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Slovenian: [Pri vseh zdravilih v Prilogi I je treba spremeniti obstoječe informacije o zdravilu (vstavitev, zamenjava ali izbris besedila, kot je primerno), da odražajo dogovorjeno besedilo, kot je navedeno spodaj.]
English: The use of <product> in the prevention of pneumonia is not recommended, as no data from clinical studies are available to demonstrate such effect.
Slovenian: Uporaba zdravila <ime zdravila> za preprečevanje pljučnice ni priporočljiva, saj ni podatkov iz kliničnih študij, ki bi dokazovali takšen učinek.
English: [Related changes should be implemented as needed throughout the SmPC]
Slovenian: [Povezane spremembe je treba po potrebi vnesti v celotnem SmPC.]
English: Therefore, the administration of <product> to prevent pneumonia is not recommended.
Slovenian: Zato uporaba zdravila <ime zdravila> za preprečevanje pljučnice ni priporočena.
English: 4.1 Therapeutic indications [For all products, indications in respiratory tract conditions should be replaced by the below ones for adults and for children]
Slovenian: 4.1 Terapevtske indikacije [Pri vseh zdravilih je treba indikacije pri boleznih dihal zamenjati s spodnjimi za odrasle in otroke.]
English: Amendments to relevant sections of the Product Information
Slovenian: Spremembe ustreznih poglavij informacij o zdravilu
English: What <product> is and what it is used for [For all products, indications in respiratory tract conditions should be replaced by the below ones for adults and for children]
Slovenian: Kaj je zdravilo <ime zdravila> in za kaj ga uporabljamo [Pri vseh zdravilih je treba indikacije pri boleznih dihal zamenjati s spodnjimi za odrasle in otroke.]
English: 4.4 Special warnings and precautions for use [For products authorised in the prophylaxis of unspecified recurrent RTI a warning should be added as follows and related changes should be implemented as needed throughout the SmPC]
Slovenian: Posebna opozorila in previdnostni ukrepi [Pri zdravilih, indiciranih za preventivo neopredeljenih ponavljajočih okužb dihal, je treba dodati spodnje opozorilo in povezane spremembe je treba po potrebi vnesti v celotnem SmPC.]
English: Prophylaxis of recurrent upper respiratory tract infections (RTI) in <age group>.
Slovenian: Preventiva ponavljajočih okužb zgornjih dihalnih poti (RTI-respiratory tract infections) pri <starostna skupina>.
English: [For products authorised in the prophylaxis of unspecified recurrent RTI a warning should be added as follows and related changes should be implemented as needed throughout the PL]
Slovenian: [Pri zdravilih , odobrenih za preprečevanje neopredeljenih ponavljajočih okužb dihal, je treba dodati spodnje opozorilo in povezane spremembe je treba po potrebi vnesti v celotnem navodilu za uporabo.]
English: [With regards to the age group, minimal age should be reflected as follows: Luivac and associated names: children from 4 years of age Buccalin and associated names: children from 2 years of age For Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum and their associated names no change is needed to the minimal age currently authorised; however the age cut off should also be reflected in the indication, in line with the SmPC guideline.]
Slovenian: Za Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum in njihova povezana imena ni potrebna sprememba pri trenutno dovoljeni najmanjši starosti, vendar pa je treba starostno mejo navesti tudi pri indikaciji, v skladu s smernico za povzetek glavnih značilnosti zdravila (SmPC).]
English: [With regards to the age group, minimal age should be reflected as follows: Luivac and associated names: children from 4 years of age Buccalin and associated names: children from 2 years of age For Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum and their associated names no change is needed to the minimal age currently authorised; however the age cut off should also be reflected in the indication] [Related changes should be implemented as needed throughout the PL]
Slovenian: Za Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum in njihova povezana imena ni potrebna sprememba pri trenutno dovoljeni najmanjši starosti, vendar pa je treba starostno mejo navesti tudi pri indikaciji.]
English: Results for study 004 were similar.
Slovenian: Rezultati za študijo 004 so bili podobni.
English: January 2005 to December 2007.
Slovenian: Januar 2005 do december 2007.
English: Based on a 5-year duration of protection.
Slovenian: Na podlagi 5-letnega trajanja zaščite.
English: Date of first authorisation: 09 December 2009 Date of latest renewal: 18 September 2014
Slovenian: Datum prve odobritve: 9. december 2009 Datum zadnjega podaljšanja: 18. september 2014
English: Canada (Quebec)
Slovenian: Kanada (Quebec)
English: Complete effectiveness for routine 2+1 schedule not yet available.
Slovenian: Celotna učinkovitost za rutinsko shemo 2+1 še ni na voljo.
English: Vaccine efficacy October 1995 to April 20, 1999 October 1995 to April 30, 1998
Slovenian: Učinkovitost cepiva Od oktobra 1995 do 20. aprila 1999 Od oktobra 1995 do 30. aprila 1998
English: For the most recent epidemiological information in your country you should consult with the relevant national organisation.
Slovenian: Za najnovejše epidemiološke podatke v vaši državi se posvetujte s pristojno nacionalno organizacijo.
English: Calculated vaccine effectiveness as of June 2008 (Broome method).
Slovenian: Izračunana učinkovitost cepiva v juniju 2008 (Broomova metoda).
English: Persons ≥ 65
Slovenian: Osebe ≥ 65
English: • if you or your child has a severe infection with a high temperature (over 38°C).
Slovenian: • če imate vi ali vaš otrok hujšo okužbo z vročino (nad 38 °C).
English: Because these reactions were derived from spontaneous reports, the frequencies could not be determined and are thus considered as not known.
Slovenian: Ker ti učinki izvirajo iz spontanih poročil, pogostnosti ni mogoče določiti in je torej opredeljena kot neznana.
English: USA (2000)
Slovenian: ZDA (2000)
English: The reductions ranged between 34% and 62% depending on serotype and antibiotic.
Slovenian: Zmanjšanja so znašala od 34 % do 62 %, odvisno od serotipa in antibiotika.
English: Per 100,000 person-years of observation.
Slovenian: Na 100.000 oseb-let opazovanja.
English: After first use, the product may be stored in a refrigerator for a maximum of 28 days.
Slovenian: Po prvi uporabi lahko izdelek shranjujete v hladilniku največ 28 dni.
English: One single dose.
Slovenian: En sam odmerek.
English: UK (England & Wales)
Slovenian: VB (Anglija & Wales)
English: These reactions were mostly moderate (less than or equal to 39°C) and transient.
Slovenian: Te reakcije so bile večinoma zmerne (temperatura nižja ali enaka 39 °C) in prehodne.
English: Incidence per 100,000 personyears of observation (PYO)
Slovenian: Incidenca na 100.000 oseb-let opazovanja (PYO)
English: See section 6.5 for the number of doses per container.
Slovenian: Glejte poglavje 6.5 za število odmerkov na vsebnik.
English: The study was not designed to demonstrate efficacy in subgroups, and the number of subjects ≥ 85 years of age was not sufficient to demonstrate efficacy in this age group.
Slovenian: Študija ni bila načrtovana za dokaz učinkovitosti pri podskupinah, število vključenih, starih 85 let in več, pa ni bilo zadostno, da bi dokazali učinkovitost pri tej starostni skupini.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Slovenian: Ker je korist cepljenja v tej skupini dojenčkov velika, se cepljenja ne sme izpustiti ali odložiti.
English: The vaccine works by helping the body to make its own antibodies, which protect you or your child against these diseases.
Slovenian: Cepivo deluje tako, da spodbudi tvorbo telesu lastnih protiteles, ki vas ali vašega otroka ščitijo pred temi boleznimi.
English: Children < 5
Slovenian: Otroci < 5
English: Prevenar 13 is stable at temperatures up to 25°C for four days.
Slovenian: Cepivo Prevenar 13 je stabilno pri temperaturah do 25 °C 4 dni.
English: ** p<0.005 to cover 6A where p=0.002
Slovenian: ** p < 0,005 z upoštevanjem 6A, kjer je p = 0,002.
English: These data are intended to guide health care professionals in case of temporary temperature excursions.
Slovenian: Ti podatki služijo kot priporočila za zdravstvene delavce v primeru začasnih odstopanj temperature.
English: The study demonstrated that safety and immunogenicity were generally comparable with observations made in studies of intramuscular administration.
Slovenian: Študija je pokazala, da sta bili varnost in imunogenost na splošno primerljivi z opažanji v študijah intramuskularne uporabe cepiva.
English: According to official recommendations in your country, an alternative schedule may be used by your healthcare provider.
Slovenian: V skladu z uradnimi priporočili v vaši državi lahko vaš ponudnik zdravstvenih storitev uporabi tudi drugačno shemo cepljenja.
English: Individuals with the conditions described below have an increased risk of pneumococcal disease.
Slovenian: Posamezniki s spodaj opisanimi stanji so izpostavljeni povečanemu tveganju za pnevmokokne bolezni.
English: 2005 data.
Slovenian: Podatki iz leta 2005.
English: The CAPiTA study enrolled volunteers ≥ 65 years of age whose demographic and health characteristics may differ from those seeking vaccination.
Slovenian: V študijo CAPiTA so bili vključeni prostovoljci, stari 65 let in več, katerih demografske in zdravstvene značilnosti se lahko razlikujejo od tistih, ki se želijo cepiti.
English: This is a multidose presentation.
Slovenian: To je večodmerna oblika.
English: The clinical relevance of the lower GMCs and GMTs is currently unknown.
Slovenian: Klinični pomen nižjih ravni GMC in GMT zaenkrat ni znan.
English: Unvaccinated Children (12-23 months)
Slovenian: Necepljeni otroci (12-23 mesecev)
English: Confidence intervals (CIs) for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.
Slovenian: Intervali zaupanja (IZ) za razmerje so povratne transformacije intervala zaupanja, zasnovanega na Studentovi tporazdelitvi za srednjo vrednost razlike logaritmov merjenj.
English: HIV infection
Slovenian: Okužba s HIV
English: • You will be told when your child should come back for the next injection.
Slovenian: • Povedali vam bodo, kdaj mora otrok prejeti naslednji odmerek.
English: For adjuvant, see section 2.
Slovenian: Za adjuvanse glejte poglavje 2.
English: 2004 data.
Slovenian: Podatki iz leta 2004.
English: Decreased appetite
Slovenian: zmanjšan apetit
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o cepivu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: In accordance with Article 114 Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Slovenian: V skladu s členom 114 Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
English: First episode of VT-IPD
Slovenian: Prva epizoda VT-IPD
English: drowsiness; restless sleep
Slovenian: zaspanost in nemirno spanje
English: Preterm infants (<37 weeks gestation)
Slovenian: Nedonošenčki (< 37 tednov nosečnosti)
English: These observations are consistent with adequate priming (the induction of immunologic memory).
Slovenian: Ta opažanja so v skladu z ustreznim osnovnim cepljenjem (indukcija imunološkega spomina).
English: A reduction in carriage was also seen for serotype 3 (2.5% vs 1.1%; p=0.1).
Slovenian: Zmanjšanje nosilstva so opazili tudi za serotip 3 (2,5 % v primerjavi z 1,1 %; p = 0,1).
English: Bacteria can be responsible for 60-70% of clinical episodes of AOM.
Slovenian: Bakterije so lahko odgovorne za od 60 do 70 % kliničnih epizod akutnega vnetja srednjega ušesa.
English: Other adverse events previously observed in infants and children 6 weeks to 5 years of age may also be applicable to this age group but were not seen in this study possibly due to the small sample size.
Slovenian: Drugi neželeni učinki, opaženi pri dojenčkih in otrocih, starih od 6 tednov do 5 let, so lahko prisotni tudi pri tej starostni skupini, vendar jih v tej študiji niso opazili, verjetno zaradi majhne velikosti vzorca.
English: It will not protect against other infectious agents that can cause ear infections.
Slovenian: Ne zaščiti pa pred drugimi povzročitelji, ki lahko povzročijo okužbe ušes.
English: The frequency is defined as follows: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
English: Convulsions (including febrile convulsions)
Slovenian: konvulzije (vključno z vročinskimi konvulzijami)
English: Immune responses to the additional 6 serotypes were also measured.
Slovenian: Ovrednotili so tudi imunske odzive na 6 dodatnih serotipov.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednega ali posrednega škodljivega vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: In this study, reductions of S. pneumoniae serotypes 19A, 19F, and 6A not susceptible to a number of antibiotics were documented.
Slovenian: V tej študiji so dokumentirali zmanjšanja S. pneumoniae serotipov 19A, 19F in 6A, ki niso bili dovzetni za številne antibiotike.
English: 9 to 122
Slovenian: 9 do 122
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o kateremkoli domnevnem neželenem učinku cepiva na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: • Worsening or new pain in your joints, worsening or new pain in your muscles
Slovenian: • poslabšanje ali novonastala bolečina v sklepih, poslabšanje ali novonastala bolečina v mišicah
English: NNV also incorporates the length of the trial or duration of protection and is calculated as 1 divided by the product of the IRR and duration of protection (or length of trial) (=1/(IRR × duration).
Slovenian: Poleg tega NNV vključuje tudi dolžino preskušanja ali trajanje zaščite in se izračuna kot 1, deljeno z zmnožkom IRR in trajanjem zaščite (ali dolžino preskušanja) (= 1/(IRR × trajanje).
English: Significant incidence reductions were also observed in older age groups who had not been vaccinated with Prevenar 13 (indirect effect).
Slovenian: Pomembna zmanjšanja incidence so ugotovili tudi pri starejših skupinah, ki niso bile cepljene s cepivom Prevenar 13 (posredni učinek).
English: See also section 4.
Slovenian: Glejte tudi poglavje 4.
English: Pharmacotherapeutic group: vaccines, pneumococcal vaccines; ATC code: J07AL02
Slovenian: Farmakoterapevtska skupina: cepiva, cepiva proti pnevmokoknim infekcijam; oznaka ATC: J07AL02.
English: There was no reduction seen in serotype 3 and for serotype 5 the colonization was too infrequent to assess impact.
Slovenian: Za serotip 3 niso opazili zmanjšanja, pri serotipu 5 pa je bila kolonizacija preveč redka, da bi lahko ocenili vpliv.
English: Other medicines/vaccines and Prevenar 13
Slovenian: Druga zdravila/cepiva in cepivo Prevenar 13
English: 5 to 186
Slovenian: 5 do 186
English: Table 2: Serotype specific number of cases and incidence reductions of IPD in 2013/14 compared to 2008/09-2009/10 (2008/10) by age in England and Wales
Slovenian: Preglednica 2: Število primerov in zmanjšanje incidence IPD za vsak serotip v obdobju 2013/14 v primerjavi z obdobjem 2008/09-2009/10 (2008/10) po starosti v Angliji in Walesu Stari < 5 let
English: • if you or your child is allergic (hypersensitive) to the active substances or to any of the other ingredients in this medicine (listed in section 6) or to any other vaccine that contains diphtheria toxoid.
Slovenian: • če ste vi ali vaš otrok alergični (preobčutljivi) na učinkovine ali katerokoli sestavino tega cepiva (navedeno v poglavju 6) ali na katerokoli drugo cepivo, ki vsebuje davični toksoid.
English: The immunogenicity after two doses in infants has been documented in four studies.
Slovenian: Imunogenost po cepljenju z dvema odmerkoma pri dojenčkih so dokumentirali v štirih študijah.
English: 18 to 381
Slovenian: 18 do 381
English: Adverse reactions from clinical studies
Slovenian: Neželeni učinki iz kliničnih študij
English: For serotype 6A
Slovenian: Za serotip 6A
English: Therefore the use of Prevenar 13 should be avoided during pregnancy.
Slovenian: Zato se je treba uporabi cepiva Prevenar 13 med nosečnostjo izogibati.
English: Infants, children, and adolescents previously vaccinated with Prevenar
Slovenian: Dojenčki, otroci in mladostniki, ki so bili predhodno cepljeni s cepivom Prevenar