natgillin/translations-raw huggingface dataset:
{PRODUCT NAME} is also indicated to reduce total-C and LDL-C in patients adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. 
Zdravilo {(Lastniško) ime} je indicirano tudi za znižanje zvišanega celotnega holesterola in holesterola LDL pri bolnikih odraslih s homozigotno obliko familiarne hiperholesterolemije kot dodatek drugim načinom terapevtskega zniževanja lipidov (npr. aferezi LDL) ali če takšni načini niso na voljo.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS 
DOPOLNILA, KI JIH JE POTREBNO VKLJUČITI V RELEVANTNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
Titration should be conducted according to the individual response and tolerability in paediatric patients. 
Prilagajanje je treba pri pediatričnih bolnikih opraviti v skladu s posameznikovim odzivom in prenašanjem.
POSSIBLE SIDE EFFECTS {To be completed nationally}. 
MOŽNI NEŽELENI UČINKI {Izpolni država članica}.
In an openlabel, 8-week study, Tanner Stage 1 (N=15) and Tanner Stage 2 (N=24) paediatric patients (ages 6-17 years) with heterozygous familial hypercholesterolemia and baseline LDL-C 4 mmol/L were treated with 5 or 10 mg of chewable or 10 or 20 mg of filmcoated atorvastatin tablets once daily, respectively. 
V odprti 8-tedenski študiji so pediatrični bolniki s stopnjo 1 po Tannerju (n = 15) in stopnjo  2 (n = 24) po Tannerju, stari od 6 do 17 let, z družinsko heterozigotno familiarno hiperholesterolemijo in izhodiščnim holesterolom LDL  4 mmol/l dobivali enkrat na dan 5 ali 10 mg atorvastatina v žvečljivih tabletah oz. 10 ali 20 mg atorvastatina v filmsko obloženih tabletah.
What {PRODUCT NAME} looks like and contents of the pack {PRODUCT NAME} 5 mg chewable tablets are white to off-white with pink to purple specks with a round shape. 
Izgled zdravila X in vsebina pakiranja {(Lastniško) ime} 5 mg žvečljive tablete so bele do umazano bele, okrogle žvečljive tablete z rožnatimi do vijoličastimi lisami.
MARKETING AUTHORISATION HOLDER [To be completed nationally] [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}> 
IMETNIK DOVOLJENJA ZA PROMET [Izpolni država članica] [Glejte Dodatek I - Izpolni država članica] {Ime in naslov} <{tel.}> <{fax}>
{To be completed nationally}. 
{Izpolni država članica}.
Apparent oral clearance of atorvastatin in paediatric subjects appeared similar to adults when scaled allometrically by body weight. 
Na telesno maso alometrično preračunani navidezni peroralni očistek atorvastatina je bil pri pediatričnih preiskovancih podoben kot pri odraslih.
4.6 Pregnancy and lactation {To be completed nationally}. 
4.6 Nosečnost in dojenje {Izpolni država članica}.
Possible side effects 
Možni neželeni učinki 5.
Marketing Authorisation Holder and Manufacturer {Name and address} <{tel}> <{fax}> <{e-mail}> [See Annex I - To be completed nationally] 
Imetnik dovoljenja za promet z zdravilom in izdelovalec {Ime in naslov} <{tel.}> <{fax}> <{e-mail}> [Glejte Dodatek I - Izpolni država članica]
6.6 Special precautions for disposal {To be completed nationally}. 
6.6 Posebni varnostni ukrepi za odstranjevanje {Izpolni država članica}.
The active substance of {PRODUCT NAME} is atorvastatin. 
Zdravilna učinkovina je atorvastatin.
Paediatric: Pharmacokinetic data in the paediatric population are not available. 
Otroci: Farmakokinetičnih podatkov za otroke ni.
{PRODUCT NAME} tablets can be chewed or swallowed whole with a drink of water, and can be taken at any time of day, with or without food. 
Vzeti jih je mogoče ob kateremkoli času dneva, s hrano ali brez nje.
They are marked with 5 on one side and Pfizer on the other side. 
Tablete imajo na eni strani vtisnjeno oznako "5" in na drugi "Pfizer".
INFORMATION IN BRAILLE {PRODUCT NAME} 5 mg chewable tablets 
PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 5 mg žvečljive tablete
Body weight was the only significant covariate in atorvastatin population PK model. 
V modelu populacijske farmakokinetike atorvastatina je bila edina statistično pomembna sospremenljivka telesna masa.
The clinical safety database includes safety data for 249 paediatric patients who received atorvastatin, among which 7 patients were < 6 years old, 14 patients were in the age range of 6 to 9, and 228 patients were in the age range of 10 to 17. 
Od tega je bilo 7 bolnikov mlajših od 6 let, 14 bolnikov je bilo starih od 6 do 9 let in 228 bolnikov od 10 do 17 let.
At Week 8, on average, the percent change from baseline in LDL-C and TC was approximately 40% and 30%, respectively, over the range of exposures. 
V celotnem razponu izpostavljenosti je bila v povprečju po 8 tednih odstotna sprememba od izhodiščnega LDL 40 % in trigliceridov 30 %.
Chewable tablet 
Žvečljiva tableta
QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 5 mg atorvastatin (as atorvastatin calcium (trihydrate)). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena žvečljiva tableta vsebuje 5 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
4.4 Special warnings and precautions for use {To be completed nationally}. 
4.4 Posebna opozorila in previdnostni ukrepi {Izpolni država članica}.
White to off-white, round chewable tablets with pink to purple specks, debossed "5" on one side and “Pfizer” on the other measuring 5.6 mm in diameter. 
Tablete imajo na eni strani vtisnjeno oznako "5" in na drugi "Pfizer" ter v premeru merijo 5,6 mm.
4.2 Posology and method of administration {To be completed nationally}. 
4.2 Odmerjanje in način uporabe {Izpolni država članica}.
{PRODUCT NAME} 5 mg chewable tablets Atorvastatin calcium [See Annex I - To be completed nationally] 
NAVODILO ZA UPORABO {(Lastniško) ime} 5 mg žvečljive tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
4.3 Contraindications {To be completed nationally}. 
4.3 Kontraindikacije {Izpolni država članica}.
Blister packs containing 30 chewable tablets. 
Pretisni omoti s 30 žvečljivimi tabletami.
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. 
Pediatrične bolnike smejo zdraviti samo zdravniki, ki imajo izkušnje z zdravljenjem pediatrične hiperlipidemije.
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. 
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.
NAME OF THE MEDICINAL PRODUCT {PRODUCT NAME} 5 mg chewable tablets Atorvastatin 
IME ZDRAVILA {(Lastniško) ime} 5 mg žvečljive tablete atorvastatin
6.4 Special precautions for storage {To be completed nationally}. 
6.4 Posebna navodila za shranjevanje {Izpolni država članica}.
5.3 Preclinical safety data 
5.3 Predklinični podatki o varnosti {Izpolni država članica}.
{PRODUCT NAME} are available in blister packs containing 30 chewable tablets. 
Zdravilo je na voljo v naslednjih pakiranjih: škatla s 30 žvečljivimi tabletami v pretisnem omotu.
LIST OF EXCIPIENTS Contains aspartame. 
SEZNAM POMOŽNIH SNOVI Pomožne snovi: aspartam.
Consistent decreases in LDL-C and TC were observed over the range of atorvastatin and o-hydroxyatorvastatin exposures. 
V razponu izpostavljenosti atorvastatinu in o-hidroksiatorvastatinu so ugotovili dosledna znižanja holesterola LDL in trigliceridov.
Atorvastatin significantly decreased plasma levels of totalC, LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase. 
Povprečne vrednosti holesterola LDL, trigliceridov, holesterola VLDL in apolipoproteina B so se pri vseh preiskovancih zmanjšale do 2. tedna.
Paediatric use 
peroralna uporaba
NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] {PRODUCT NAME} 5 mg chewable tablet 
IME ZDRAVILA [Glejte Dodatek I - Izpolni država članica] {(Lastniško) ime} 5 mg žvečljiva tableta
Common: Abdominal pain 
Pogosti: bolečine v trebuhu
How to take {PRODUCT NAME} 4. 
Kako jemati zdravilo X 4.
Each tablet contains 5 mg of atorvastatin as atorvastatin calcium trihydrate. 
Ena tableta vsebuje 5 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
NAME OF THE MARKETING AUTHORISATION HOLDER [To be completed nationally] {Name} 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Izpolni država članica] {ime}
Before you take {PRODUCT NAME} 3. 
Kaj morate vedeti, preden boste vzeli zdravilo X 3.
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. 
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.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 5 mg atorvastatin (as calcium salt trihydrate). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena žvečljiva tableta vsebuje 5 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
{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. 
Tablete {(Lastniško) ime} je treba prežvečiti ali jih pogoltniti cele z nekaj vode.
Pediatric use should only be carried out by specialists. 
Otroke mora zdraviti specialist.
Hydroxypropyl cellulose 
Hiperholesterolemija
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. 
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.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET 
DOPOLNILA, KI JIH JE POTREBNO VKLJUČITI V RELEVANTNA POGLAVJA NAVODILA ZA UPORABO
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. 
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.
These amendments to the relevant sections of the Product Information are the outcome of the referral procedure. 
Te spremembe ustreznih poglavij informacij o zdravilu so rezultat napotitvenega postopka.
What you need to know before you use <product> 
Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila>
No data from clinical studies are available to demonstrate that the use of <product> can prevent pneumonia. 
Ni podatkov iz kliničnih študij, ki kažejo, da lahko uporaba zdravila <ime zdravila> prepreči pljučnico.
[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] 
[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.]
The use of <product> in the prevention of pneumonia is not recommended, as no data from clinical studies are available to demonstrate such effect. 
Uporaba zdravila <ime zdravila> za preprečevanje pljučnice ni priporočljiva, saj ni podatkov iz kliničnih študij, ki bi dokazovali takšen učinek.
[Related changes should be implemented as needed throughout the SmPC] 
[Povezane spremembe je treba po potrebi vnesti v celotnem SmPC.]
Therefore, the administration of <product> to prevent pneumonia is not recommended. 
Zato uporaba zdravila <ime zdravila> za preprečevanje pljučnice ni priporočena.
4.1 Therapeutic indications [For all products, indications in respiratory tract conditions should be replaced by the below ones for adults and for children] 
4.1 Terapevtske indikacije [Pri vseh zdravilih je treba indikacije pri boleznih dihal zamenjati s spodnjimi za odrasle in otroke.]
Amendments to relevant sections of the Product Information 
Spremembe ustreznih poglavij informacij o zdravilu
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] 
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.]
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] 
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.]
Prophylaxis of recurrent upper respiratory tract infections (RTI) in <age group>. 
Preventiva ponavljajočih okužb zgornjih dihalnih poti (RTI-respiratory tract infections) pri <starostna skupina>.
[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] 
[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.]
[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.] 
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).]
[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] 
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.]
Results for study 004 were similar. 
Rezultati za študijo 004 so bili podobni.
January 2005 to December 2007. 
Januar 2005 do december 2007.
Based on a 5-year duration of protection. 
Na podlagi 5-letnega trajanja zaščite.
Date of first authorisation: 09 December 2009 Date of latest renewal: 18 September 2014 
Datum prve odobritve: 9. december 2009 Datum zadnjega podaljšanja: 18. september 2014
Complete effectiveness for routine 2+1 schedule not yet available. 
Celotna učinkovitost za rutinsko shemo 2+1 še ni na voljo.
Vaccine efficacy October 1995 to April 20, 1999 October 1995 to April 30, 1998 
Učinkovitost cepiva Od oktobra 1995 do 20. aprila 1999 Od oktobra 1995 do 30. aprila 1998
For the most recent epidemiological information in your country you should consult with the relevant national organisation. 
Za najnovejše epidemiološke podatke v vaši državi se posvetujte s pristojno nacionalno organizacijo.
Calculated vaccine effectiveness as of June 2008 (Broome method). 
Izračunana učinkovitost cepiva v juniju 2008 (Broomova metoda).
Persons ≥ 65 
Osebe ≥ 65
• if you or your child has a severe infection with a high temperature (over 38°C). 
• če imate vi ali vaš otrok hujšo okužbo z vročino (nad 38 °C).
Because these reactions were derived from spontaneous reports, the frequencies could not be determined and are thus considered as not known. 
Ker ti učinki izvirajo iz spontanih poročil, pogostnosti ni mogoče določiti in je torej opredeljena kot neznana.
USA (2000) 
ZDA (2000)
The reductions ranged between 34% and 62% depending on serotype and antibiotic. 
Zmanjšanja so znašala od 34 % do 62 %, odvisno od serotipa in antibiotika.
Per 100,000 person-years of observation. 
Na 100.000 oseb-let opazovanja.
After first use, the product may be stored in a refrigerator for a maximum of 28 days. 
Po prvi uporabi lahko izdelek shranjujete v hladilniku največ 28 dni.
One single dose. 
En sam odmerek.
UK (England & Wales) 
VB (Anglija & Wales)
These reactions were mostly moderate (less than or equal to 39°C) and transient. 
Te reakcije so bile večinoma zmerne (temperatura nižja ali enaka 39 °C) in prehodne.
Incidence per 100,000 personyears of observation (PYO) 
Incidenca na 100.000 oseb-let opazovanja (PYO)
See section 6.5 for the number of doses per container. 
Glejte poglavje 6.5 za število odmerkov na vsebnik.
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. 
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.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. 
Ker je korist cepljenja v tej skupini dojenčkov velika, se cepljenja ne sme izpustiti ali odložiti.
The vaccine works by helping the body to make its own antibodies, which protect you or your child against these diseases. 
Cepivo deluje tako, da spodbudi tvorbo telesu lastnih protiteles, ki vas ali vašega otroka ščitijo pred temi boleznimi.
Children < 5 
Otroci < 5
Prevenar 13 is stable at temperatures up to 25°C for four days. 
Cepivo Prevenar 13 je stabilno pri temperaturah do 25 °C 4 dni.
** p<0.005 to cover 6A where p=0.002 
** p < 0,005 z upoštevanjem 6A, kjer je p = 0,002.
These data are intended to guide health care professionals in case of temporary temperature excursions. 
Ti podatki služijo kot priporočila za zdravstvene delavce v primeru začasnih odstopanj temperature.
The study demonstrated that safety and immunogenicity were generally comparable with observations made in studies of intramuscular administration. 
Študija je pokazala, da sta bili varnost in imunogenost na splošno primerljivi z opažanji v študijah intramuskularne uporabe cepiva.
According to official recommendations in your country, an alternative schedule may be used by your healthcare provider. 
V skladu z uradnimi priporočili v vaši državi lahko vaš ponudnik zdravstvenih storitev uporabi tudi drugačno shemo cepljenja.
Individuals with the conditions described below have an increased risk of pneumococcal disease. 
Posamezniki s spodaj opisanimi stanji so izpostavljeni povečanemu tveganju za pnevmokokne bolezni.
2005 data. 
Podatki iz leta 2005.
The CAPiTA study enrolled volunteers ≥ 65 years of age whose demographic and health characteristics may differ from those seeking vaccination. 
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.
This is a multidose presentation. 
To je večodmerna oblika.
The clinical relevance of the lower GMCs and GMTs is currently unknown. 
Klinični pomen nižjih ravni GMC in GMT zaenkrat ni znan.
Unvaccinated Children (12-23 months) 
Necepljeni otroci (12-23 mesecev)
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. 
Intervali zaupanja (IZ) za razmerje so povratne transformacije intervala zaupanja, zasnovanega na Studentovi tporazdelitvi za srednjo vrednost razlike logaritmov merjenj.
• You will be told when your child should come back for the next injection. 
• Povedali vam bodo, kdaj mora otrok prejeti naslednji odmerek.
For adjuvant, see section 2. 
Za adjuvanse glejte poglavje 2.
2004 data. 
Podatki iz leta 2004.
Decreased appetite 
zmanjšan apetit
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Podrobne informacije o cepivu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
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. 
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.
First episode of VT-IPD 
Prva epizoda VT-IPD
drowsiness; restless sleep 
zaspanost in nemirno spanje
Preterm infants (<37 weeks gestation) 
Nedonošenčki (< 37 tednov nosečnosti)
These observations are consistent with adequate priming (the induction of immunologic memory). 
Ta opažanja so v skladu z ustreznim osnovnim cepljenjem (indukcija imunološkega spomina).
A reduction in carriage was also seen for serotype 3 (2.5% vs 1.1%; p=0.1). 
Zmanjšanje nosilstva so opazili tudi za serotip 3 (2,5 % v primerjavi z 1,1 %; p = 0,1).
Bacteria can be responsible for 60-70% of clinical episodes of AOM. 
Bakterije so lahko odgovorne za od 60 do 70 % kliničnih epizod akutnega vnetja srednjega ušesa.
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. 
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.
It will not protect against other infectious agents that can cause ear infections. 
Ne zaščiti pa pred drugimi povzročitelji, ki lahko povzročijo okužbe ušes.
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). 
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).
Convulsions (including febrile convulsions) 
konvulzije (vključno z vročinskimi konvulzijami)
Immune responses to the additional 6 serotypes were also measured. 
Ovrednotili so tudi imunske odzive na 6 dodatnih serotipov.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 
Študije na živalih ne kažejo neposrednega ali posrednega škodljivega vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).