natgillin/translations-raw huggingface dataset:
During the first year, significantly fewer subjects in the Rotarix group reported severe rotavirus gastroenteritis caused by the circulating wild-type RV compared to the placebo group from 2 weeks after Dose 2 up to one year of age (0.0% versus 0.3%), with a vaccine efficacy of 100% (95% CI: 72.2; 
V prvem letu so pri prejemnikih cepiva Rotarix zabeležili značilno manj primerov hudega rotavirusnega gastroenteritisa, ki ga je povzročil krožeči divji tip RV, kot pri prejemnikih placeba, in sicer od 2. tedna po 2. odmerku do enega leta starosti (0,0 % v primerjavi z 0,3 %), pri čemer je bila učinkovitost cepiva 100 % (95 % IZ: 72,2; 100).
The vaccine contains sucrose and sorbitol as excipients. 
Cepivo vsebuje saharozo in sorbitol kot pomožni snovi.
After reconstitution: The reconstituted vaccine is slightly more turbid than the solvent and is milky white in appearance. 
Rekonstituirano cepivo je nekoliko bolj motno kot vehikel in mlečno belo.
• if your child has diarrhoea or is vomiting. 
• če ima drisko ali bruha.
A clinical study performed in Africa (Rotarix: N = 2,974; placebo: N = 1,443) evaluated Rotarix given at approximately 10 and 14 weeks of age (2 doses) or 6, 10 and 14 weeks of age (3 doses). 
Klinična študija, izvedena v Afriki (cepivo Rotarix: n = 2.974; placebo: n = 1.443), je ovrednotila cepivo Rotarix dano v starosti približno 10 in 14 tednov (2 odmerka) ali v starosti približno 6, 10 in 14 tednov (3 odmerki).
Administration of Rotarix should be postponed in subjects suffering from acute severe febrile illness. 
Cepljenje s cepivom Rotarix je treba odložiti pri osebah, ki prebolevajo hudo akutno vročinsko bolezen.
Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus. 
Cepivo Rotarix ne ščiti pred gastroenteritisom, ki ga povzročajo drugi povzročitelji in ne rotavirusi.
Position the cap to open the tube 
Namestitev zaporke za odprtje tube
The first dose may be administered from the age of 6 weeks. 
Prvi odmerek lahko apliciramo od starosti 6 tednov dalje.
Vaccine efficacy during the first year of life progressively increased with increasing disease severity, reaching 100% (95% CI: 84.7;100) for Vesikari scores ≥17. 
Med prvim letom življenja se učinkovitost cepiva progresivno povečuje s povečevanjem resnosti bolezni in pri oceni ≥ 17 po Vesikariju doseže 100 % (95% interval zaupanja: 84,7;100).
A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastro-enteritis has not been established. 
Povezave med pojavom protiteles zaradi cepljenja s cepivom proti rotavirusom in zaščito pred rotavirusnim gastroenteritisom niso dokazali.
† Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale 
† Hud gastroenteritis je bil opredeljen kot ocena ≥ 11 na Vesikarijevi lestvici
Severity of gastro-enteritis was defined according to two different criteria: - the Vesikari 20-point scale, which evaluates the full clinical picture of rotavirus gastro-enteritis by taking into account the severity and duration of diarrhoea and vomiting, the severity of fever and dehydration as well as the need for treatment or - the clinical case definition based on World Health Organization (WHO) criteria 
Resnost gastroenteritisa je bila definirana po dveh različnih kriterijih: - z 20-točkovno Vesikarijevo lestvico, ki upošteva tako celotno klinično sliko rotavirusnega gastroenteritisa (resnost in trajanje driske ter bruhanja, resnost povišane telesne temperature in dehidracije) kot tudi potrebo po zdravljenju; ali
The efficacy against severe RV gastro-enteritis requiring hospitalisation was 100% (95% CI: 72.4; 100). 
Učinkovitost proti hudem RV gastroenteritisu, ki je zahteval sprejem v bolnišnico, je bila 100 % (95 % IZ: 72,4; 100).
In two comparative controlled trials, vaccine shedding after vaccination with Rotarix liquid formulation was comparable to that observed after vaccination with Rotarix lyophilised formulation. 
V dveh primerjalnih nadzorovanih preskušanjih je bilo izločanje vakcinalnega virusa po cepljenju s cepivom Rotarix v tekoči obliki primerljivo z izločanjem vakcinalnega virusa po cepljenju s cepivom Rotarix v liofilizirani obliki.
Rotarix is supplied as clear and colourless liquid in 5 single dose squeezable tubes (5 x 1.5 ml) connected by a bar. 
Cepivo Rotarix je bistra in brezbarvna tekočina v 5-ih enoodmernih stisljivih tubah (5 x 1,5 ml), ki so med seboj povezane s ploščico.
Name and address of the manufacturer(s) of the biological active substance(s) 
ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (učinkovin)
In a pooled analysis from seventeen placebo-controlled clinical trials (Europe, North America, Latin America, Asia, Africa) including trials in which Rotarix was co-administered with routine paediatric vaccines (see section 4.5), the following adverse reactions (collected 31 days post-vaccination) were considered as possibly related to vaccination. 
Amerika, Latinska Amerika, Azija, Afrika), vključno s preskušanji, v katerih so cepivo Rotarix uporabili sočasno z običajno rabljenimi pediatričnimi cepivi (glejte poglavje 4.5), so naslednje neželene učinke (zbrane 31 dni po cepljenju) ocenili kot morebiti povezane s cepljenjem.
Transfer the entire content of the oral applicator into the glass container containing the powder 
Celotno vsebino peroralnega aplikatorja iztisnite v stekleničko s praškom.
Instructions for administration of the vaccine: 
Navodila za aplikacijo cepiva:
Mexico 
Mehika
This vaccine is intended for oral administration only. 
To cepivo je namenjeno izključno za peroralno aplikacijo.
Read all of this leaflet carefully before your child receives this vaccine because it contains important information for you. 
Preden bo vaš otrok prejel cepivo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. 
Najbolje je, da cepljenje z obema odmerkoma opravimo pred dopolnjenim 16. tednom starosti, vsekakor pa mora biti cepljenje z obema odmerkoma zaključeno pred dopolnjenim 24. tednom starosti.
Rotarix is available in a pack of 1, 10 or 50. 
Cepivo Rotarix je na voljo v pakiranjih po 1, 5, 10 ali 50.
However, in the unlikely event that an infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit. 
Kljub temu pa lahko, v sicer malo verjetnih primerih, ko otrok izpljune ali regurgitira večino odmerka cepiva, ob istem obisku apliciramo enkraten nadomestni odmerek.
1st year of life Rotarix N=2,572 Placebo N=1,302 
Prvo leto življenja Rotarix n=2.572 Placebo n=1.302
MARKETING AUTHORISATION NUMBER(S) EU/1/05/330/012 - pack of 50 tubes 13. 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/330/012 - pakiranje s 50 tubami
These data should be interpreted with caution # The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very small (1 case in the Rotarix group and 2 cases in the placebo group) 
# Število oseb, na katerih temelji ocena učinkovitosti proti G4P[8] je zelo majhno (1 oseba v skupini, ki je prejela cepivo Rotarix in 2 osebi v skupini, ki je prejela placebo).
A clinical study conducted in Asia (Hong Kong, Singapore and Taiwan) (Total vaccinated cohort : Rotarix: N = 5,359; placebo: N = 5,349) evaluated Rotarix given according to different schedules (2, 4 months of age; 3, 4 months of age). 
Klinična študija, ki so jo izvedli v Aziji (Hongkong, Singapur in Tajvan) (celotna cepljena kohorta: Rotarix: n = 5.359, placebo: n = 5.349), je ocenila cepivo Rotarix, uporabljeno po različnih shemah (2. in 4. mesec starosti, 3. in 4. mesec starosti).
After reconstitution, the vaccine contained in the oral applicator should be administered promptly. 
Po rekonstituciji je treba cepivo v peroralnem aplikatorju uporabiti takoj.
NA(7) 
NP (7)
• if your child has a rare inherited illness which affects their immune system called Severe Combined Immunodeficiency (SCID). 
• če ima redko dedno bolezen, imenovano huda kombinirana imunska pomanjkljivost (SCID), ki prizadene njegov imunski sistem;
Oral suspension in pre-filled oral applicator 1 pre-filled oral applicator 1 dose (1.5 ml) 
Peroralna suspenzija v napolnjenem peroralnem aplikatorju 1 napolnjen peroralni aplikator 1 odmerek (1,5 ml)
Taiwan were calculated using combined rotavirus-negative hospital control and non-diarrhoea hospital control participants). 
(4) Učinkovitost cepiva je bila izračunana z uporabo za rotavirus negativnih bolnišničnih kontrolnih preiskovancev (pri računanju ocene za Tajvan se je združilo kontrolne za rotavirus negativne bolnišnične preiskovance in kontrolne bolnišnične preiskovance brez diareje).
Both components must be mixed together before your child receives the vaccine. 
Preden bo vaš otrok prejel cepivo, je treba obe sestavini zmešati skupaj.
Rotavirus vaccine, live 
Cepivo proti rotavirusom, živo
A. What you need to do before giving Rotarix 
A. Kaj morate narediti pred dajanjem cepiva Rotarix 1.
Immune response in preterm infants 
Imunski odziv pri nedonošenčkih
EU/1/05/330/001 - pack of 1 (glass container + oral applicator + transfer adapter) EU/1/05/330/002 - pack of 5 (glass container + oral applicator + transfer adapter) EU/1/05/330/003 - pack of 10 (glass container + oral applicator + transfer adapter) EU/1/05/330/004 - pack of 25 (glass container + oral applicator + transfer adapter) 
EU/1/05/330/001- pakiranje po 1 (steklenička + peroralni aplikator + nastavek za prenos) EU/1/05/330/002 - pakiranje po 5 (steklenička + peroralni aplikator + nastavek za prenos) EU/1/05/330/003 - pakiranje po 10 (steklenička + peroralni aplikator + nastavek za prenos) EU/1/05/330/004 - pakiranje po 25 (steklenička + peroralni aplikator + nastavek za prenos)
Dulbecco's Modified Eagle Medium (DMEM) 
Dulbekov spremenjeni nujni medij (DMEM - »Dulbecco's Modified Eagle Medium«) voda za injekcije
Human rotavirus RIX4414 strain (live, attenuated)* 
Humani rotavirus, sev RIX4414 (živ, atenuiran)*
Human rotavirus RIX4414 strain (live, attenuated) 
Humani rotavirus, sev RIX4414 (živ, atenuiran)
In a clinical study, 100 infants with HIV infection were administered Rotarix lyophilised formulation or placebo. 
V klinični študiji je 100 dojenčkov, okuženih s HIV, dobilo cepivo Rotarix ali placebo.
The reconstituted vaccine will appear more turbid than the solvent alone. 
Rekonstituirano cepivo je bolj motno kot sam vehikel.
Haematochezia 
hematohezija
Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code: J07BH01 Protective efficacy of the lyophilised formulation 
oznaka ATC: J07BH01 Učinkovitost zaščite liofilizirane oblike cepiva
Severe rotavirus gastroenteritis† (2nd year of life) Rotarix N=7,175 Placebo N=7,062 
Hud rotavirusni gastroenteritis† (drugo leto življenja) Rotarix n = 7.175 Placebo n = 7.062
f) Twist the separated oral tube. 
f) Zavrtite ločeno tubo.
In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given. 
Med kliničnimi preskušanji je redko prihajalo do izpljuvanja ali regurgitacije cepiva.
For instructions for the preparation or reconstitution of the medicinal product before administration, see section 6.6. 
Za navodila glede priprave ali rekonstitucije cepiva pred dajanjem glejte poglavje 6.6. 4.3 Kontraindikacije
In addition, efficacy against uncommon rotavirus genotypes G8P[4](severe gastro-enteritis) and G12P[6] (any gastro-enteritis) has been demonstrated. 
Poleg tega so dokazali učinkovitost proti manj pogostima rotavirusnima genotipoma G8P[4] (hud gastroenteritis) in G12P[6] (gastroenteritis katerekoli jakosti).
• Then lift off the cap. 
• Nato odstranite zaporko.
MARKETING AUTHORISATION NUMBER(S) EU/1/05/330/009 - pack of 1 tube EU/1/05/330/010 - pack of 10 tubes EU/1/05/330/011 - pack of 50 tubes 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/330/009 - pakiranje z 1 tubo EU/1/05/330/010 - pakiranje z 10 tubami EU/1/05/330/011 - pakiranje s 50 tubami
If your child gets any of the side effects, talk to your doctor or pharmacist. 
- Če pri vašem otroku opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
Circulating rotavirus strains † Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale 
Krožeči sevi rotavirusov † Hud rotavirusni gastroenteritis je bil definiran z oceno ≥ 11 na Vesikarijevi lestvici.
Withdraw the entire mixture back into the oral applicator 
Celotno vsebino rekonstituiranega cepiva potegnite nazaj v peroralni aplikator.
Brazil 
Brazilija
The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting. 
Cepljenje s cepivom Rotarix je treba odložiti pri osebah, ki imajo drisko ali bruhajo.
After your child has received Rotarix, contact a doctor/health care professional right away if your child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever (see also section 4 “Possible side effects”). 
Če se otroku, ki je dobil cepivo Rotarix, pojavijo hude bolečine v trebuhu, dolgotrajno bruhanje, kri v blatu, napihnjen trebuh in/ali močno zvišana telesna temperatura, se morate nemudoma posvetovati z zdravnikom ali drugim zdravstvenim osebjem (glejte tudi poglavje 4 »Možni neželeni učinki«).
C. Give the vaccine orally immediately after opening 
C. Cepivo dajte peroralno takoj po odprtju tube 1.
Since the immune response observed after 2 doses of Rotarix liquid formulation was comparable to the immune response observed after 2 doses of Rotarix lyophilised formulation, the levels of vaccine efficacy observed with the lyophilised formulation can be extrapolated to the liquid formulation. 
Ker je imunski odziv, opažen po aplikaciji 2 odmerkov tekoče oblike cepiva Rotarix, primerljiv z imunskim odzivom po aplikaciji 2 odmerkov liofilizirane oblike cepiva Rotarix, lahko domnevamo, da je učinkovitost zaščite tekoče oblike enaka učinkovitosti zaščite liofilizirane oblike.
The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration. 
Cepivo je bistra in brezbarvna tekočina brez vidnih delcev za peroralno uporabo.
Strains with P[8] genotype † Severe rotavirus gastro-enteritis was defined as an episode of diarrhoea with or without vomiting that required hospitalization and/or re-hydration therapy in a medical facility (WHO criteria) * Not statistically significant (p ≥ 0.05). 
Sevi z genotipom P[8] † Hud rotavirusni gastroenteritis je bil opredeljen kot obdobje driske (z bruhanjem ali brez njega), ki je zahtevalo sprejem v bolnišnico in/ali rehidracijsko zdravljenje v zdravstveni ustanovi (merila Svetovne zdravstvene organizacije).
In a clinical study, 670 pre-term infants from 27 to 36 weeks of gestational age were administered Rotarix and 339 received placebo. 
V klinični študiji je 670 nedonošenčkov z gestacijsko starostjo od 27 do 36 tednov dobilo cepivo Rotarix, 339 pa placebo.
B Get the tube ready 
B Priprava tube
Severe rotavirus gastroenteritis† (1st year of life) Rotarix N=9,009 Placebo N=8,858 
Hud rotavirusni gastroenteritis† (prvo leto življenja) Rotarix n = 9.009 Placebo n = 8.858
Similar rates of other adverse events were observed in Rotarix and placebo recipients. 
Deleži ostalih neželenih učinkov so bili med prejemniki cepiva Rotarix in placeba podobni.
In a total of twenty-three clinical trials, approximately 106,000 doses of Rotarix (lyophilised or liquid formulation) were administered to approximately 51,000 infants. 
Izvedenih je bilo triindvajset kliničnih preskušanj, v katerih je približno 51.000 otrok prejelo približno 106.000 odmerkov cepiva Rotarix (liofilizirana ali tekoča oblika).
A What you need to do before giving Rotarix 
A Kaj morate narediti pred dajanjem cepiva Rotarix
1 dose of powder in a glass container (type I glass) with a stopper (rubber butyl) 1 ml of solvent in an oral applicator (type I glass) with a plunger stopper and a protective tip cap (rubber butyl). 
1 ml vehikla v peroralnem aplikatorju (steklo tipa I) z batnim zamaškom in zaščitnim pokrovčkom (butilna guma).
In a clinical study, 670 pre-term infants from 27 to 36 weeks of gestational age were administered Rotarix lyophilised formulation and 339 received placebo. 
V klinični študiji je 670 nedonošenčkov z gestacijsko starostjo od 27 do 36 tednov dobilo liofilizirano obliko cepiva Rotarix, 339 pa placebo.
How Rotarix is given 
Kako se cepivo Rotarix uporablja
See the package leaflet for further information 
Za dodatne informacije glejte navodilo za uporabo.
The doctor or nurse will administer the recommended dose of Rotarix to your child. 
Priporočeni odmerek cepiva Rotarix bo vašemu otroku dal zdravnik ali medicinska sestra.
EU/1/05/330/005 - pack of 1 pre-filled oral applicator EU/1/05/330/006 - pack of 5 pre-filled oral applicators EU/1/05/330/007 - pack of 10 pre-filled oral applicators EU/1/05/330/008 - pack of 25 pre-filled oral applicators 
EU/1/05/330/005 - pakiranje z 1 napolnjenim peroralnim aplikatorjem EU/1/05/330/006 - pakiranje s 5 napolnjenimi peroralnimi aplikatorji EU/1/05/330/007 - pakiranje s 10 napolnjenimi peroralnimi aplikatorji EU/1/05/330/008 - pakiranje s 25 napolnjenimi peroralnimi aplikatorji
In three placebo-controlled clinical trials (Finland, India and Bangladesh), in which Rotarix was administered alone (administration of routine paediatric vaccines was staggered), the incidence and severity of the solicited events (collected 8 days post-vaccination), diarrhoea, vomiting, loss of appetite, fever, irritability and cough/runny nose were not significantly different in the group receiving Rotarix when compared to the group receiving placebo. 
V skupini, ki je prejela cepivo Rotarix, se pojavnost in resnost nespontano navedenih učinkov (zbranih 8 dni po cepljenju), driske, bruhanja, izgube apetita, povišane telesne temperature, razdražljivosti in kašlja/izcedka iz nosu ni pomembno razlikovala od pojavnosti v skupini, ki je prejela placebo.
Therefore, breast-feeding may be continued during the vaccination schedule. 
Med cepljenjem z obema odmerkoma cepiva se torej lahko nadaljuje z dojenjem.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (1.5 ml) 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek (1,5 ml)
Pre-filled oral applicator EU/1/05/330/005 
Napolnjen peroralni aplikator EU/1/05/330/005
• in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination. 
• pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti) se lahko v dveh do treh dneh po cepljenju pojavijo med vdihi daljši presledki, kot je normalno • otroci z redko dedno boleznijo, imenovano huda kombinirana imunska pomanjkljivost
A clinical study performed in Europe evaluated Rotarix given according to different European schedules (2, 3 months; 2, 4 months; 3, 4 months; 3, 5 months) in 4,000 subjects. 
Klinična študija, izvedena v Evropi, je pri približno 4.000 osebah vrednotila dajanje cepiva Rotarix po različnih shemah dajanja, ki se uporabljajo v Evropi (2. in 3. mesec; 2. in 4. mesec; 3. in 4. mesec; 3.
Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was shown to be maintained in a clinical trial involving more than 4,200 subjects who received Rotarix concomitantly with OPV. 
Zaradi sočasnega dajanja cepiva Rotarix in OPV se imunski odziv na cepivo proti rotavirusom sicer lahko nekoliko zmanjša, vendar pa je klinično preskušanje, v katerega je bilo vključenih več kot 4.200 oseb, ki so cepivo Rotarix prejele skupaj z OPV, pokazalo,
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. 
Pred aplikacijo morate preveriti videz cepiva glede morebitne prisotnosti kakršnihkoli tujih delcev in/ali neobičajnega fizikalnega videza.
• Very rare: intussusception (part of the intestine gets blocked or twisted). 
• zelo redki: invaginacija (zapora ali zasukanje dela črevesa).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (1 ml) 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek (1 ml)
In observational studies, vaccine effectiveness was demonstrated against severe gastro-enteritis leading to hospitalisation due to rotavirus of common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8] as well as the less common rotavirus genotypes G9P[4] and G9P[6]. 
V opazovalnih študijah so dokazali učinkovitost cepiva proti hudemu gastroenteritisu, ki zahteva sprejem v bolnišnico in ga povzročajo pogosti rotavirusni genotipi G1P[8], G2P[4], G3P[8], G4P[8] in G9P[8], kot tudi manj pogosta rotavirusna genotipa G9P[4] in G9P[6].
Check the liquid in the oral tubes is clear, colourless and free from any particles. 
Preverite, da je tekočina v tubi bistra in brezbarvna ter da v njej ni delcev.
Remove the plastic cover from the glass container containing the powder 
S stekleničke s praškom odstranite plastični pokrovček.
b) With your other hand, hold the tab of the oral tube next to it. c) Pull the tab and tear it away from the oral tube next to it. 
c) Povlecite dno in ga odtrgajte od sosednje tube.
Remove the protective tip cap from the oral applicator. 
S peroralnega aplikatorja odstranite zaščitni pokrovček.
- If you get any side effects, talk to your doctor or pharmacist. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
50 tubes 50 x 1 dose (1.5 ml) 
50 tub 50 x 1 odmerek (1,5 ml)
< 4 yrs 
< 4 leta
Repeatedly flick the top of the tube until it is clear of any liquid 
Večkrat frcnite vrh tube, dokler na njem ni več tekočine • S frcanjem tik pod membrano odstranite vso tekočino iz najtanjšega predela tube.
Rotarix may be given at the same time your child receives other normally recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C conjugate vaccines. 
Otrok lahko cepivo Rotarix prejme sočasno z drugimi predpisanimi cepivi, kot so cepivo proti davici, tetanusu in oslovskemu kašlju, cepivo proti hemofilusu influence tipa b, peroralno ali inaktivirano cepivo proti otroški ohromelosti, cepivo proti hepatitisu B, konjugirano cepivo proti pnevmokokom in konjugirano cepivo proti meningokokom serološke skupine C.
Connecting bar 
POVEZANE S PLOŠČICO
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Rotarix 
IME ZDRAVILA IN POT(I) UPORABE Vehikel za Rotarix peroralna uporaba
Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus infection. 
Cepivo vašega otroka, starejšega od 6 tednov, pomaga ščititi pred gastroenteritisom (drisko in bruhanjem), ki ga povzročajo rotavirusi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED ORAL APPLICATOR, PACK SIZE OF 1, 5, 10 OR 25 
PODATKI NA ZUNANJI OVOJNINI NAPOLNJENI PERORALNI APLIKATOR, VELIKOST PAKIRANJA 1, 5, 10 ALI 25
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TUBE 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH TUBA
8-11 m 
8-11 mesecev vsi
Discard the used oral tubes in approved biological waste containers according to local regulations. 
Uporabljeno tubo zavrzite v ustrezen vsebnik za odstranjevanje bioloških odpadkov v skladu z lokalnimi predpisi.
10 tubes 10 x 1 dose (1.5 ml) 
10 tub 10 x 1 odmerek (1,5 ml)
The protective vaccine efficacy (pooled doses) observed against any and severe rotavirus gastro-enteritis is presented in the following table: 
Učinkovitost zaščite cepiva (združeni odmerki), ki je bila opažena proti rotavirusnemu gastroenteritisu katerekoli jakosti in proti hudemu rotavirusnemu gastroenteritisu, je predstavljena v spodnji preglednici:
• Once the tube is open check the liquid is clear, 
• Ko je tuba odprta, preverite, da je tekočina bistra, brez prisotnih delcev.
Oral applicator 
Peroralni aplikator