natgillin/translations-raw huggingface dataset:
• if your child was born with a malformation of the gut that could lead to intussusception. 
• če se je rodil z nepravilnostjo črevesja, ki bi lahko povzročila invaginacijo;
Rotarix with food and drink 
Uporaba cepiva Rotarix skupaj s hrano in pijačo
Immune response 
Imunski odziv
There is also a transfer adapter which allows easy transfer of the solvent into the glass container containing the powder for mixing the different components of the vaccine. 
Priložen je tudi nastavek za prenos, ki omogoča enostaven prenos vehikla v stekleničko s praškom in s tem pripravo mešanice dveh različnih sestavin cepiva.
§NOTE : Impact studies are meant to establish a temporal relationship but not a causal relationship between the disease and vaccination. 
§OPOMBA: Namen študij vpliva je ugotoviti časovno povezanost med boleznijo in cepljenjem, ne vzročne povezanosti.
This product contains sucrose 9 mg and sorbitol 13.5 mg (see section 4.4). 
Cepivo vsebuje 9 mg saharoze in 13,5 mg sorbitola (glejte poglavje 4.4).
Administration of Rotarix to infants who have known or suspected immunodeficiency, including in utero exposure to an immunosuppressive treatment, should be based on careful consideration of potential benefits and risks. 
Uporaba cepiva Rotarix pri dojenčkih z znano imunsko pomanjkljivostjo ali sumom nanjo, vključno z in utero izpostavljenostjo imunosupresivnemu zdravljenju, mora temeljiti na natančni oceni možnih koristi in tveganj.
(7) NA: Not available. 
(7) NP: ni podatka.
The first dose was administered from 6 weeks after birth. 
Prvi odmerek so dobili po 6. tednu po rojstvu.
The safety profile presented below is based on data from clinical trials conducted with either the lyophilised or the liquid formulation of Rotarix. 
Spodaj predstavljene varnostne značilnosti temeljijo na podatkih iz kliničnih preskušanj, opravljenih bodisi z liofilizirano ali tekočo obliko cepiva Rotarix.
- Squeezable tube fitted with a membrane and a tube cap: 3 years 
- Tuba z membrano in pokrita z zaporko tube: 3 leta
There should be an interval of at least 4 weeks between doses. 
Med obema odmerkoma morajo miniti vsaj 4 tedni.
Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy of Rotarix. 
Ni pričakovati, da bi asimptomatske ali blago simptomatske okužbe s HIV vplivale na varnost ali učinkovitost cepiva Rotarix.
• if your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment). 
• če je predhodno imel invaginacijo črevesja (črevesno zaporo, pri kateri se en del črevesja uviha v drugega);
N % ≥ 20U/ml [95% CI] 
% ≥ 20 e./ml [95 % IZ]
Rotarix is available in a pack of 50 tubes. 
Cepivo Rotarix je na voljo v pakiranju po 50 tub.
Besides, the SmPC of immunosuppressive therapies, such as adalimumab, infliximab, includes a recommendation to defer live vaccine administration in infants who were exposed in utero to these treatments. 
Poleg tega je v SmPC-ju imunosupresivnih zdravil, kot so adalimumab, infliksimab, priporočilo, da se preloži cepljenje z živimi cepivi pri dojenčkih, ki so bili in utero izpostavljeni tem zdravilom.
A clinical study performed in Latin America evaluated Rotarix in more than 20,000 subjects. 
Klinična študija, izvedena v Latinski Ameriki, je cepivo Rotarix ovrednotila pri več kot 20.000 osebah.
In order to strengthen the current warning on administration of Rotarix to infants who have known or suspected immunodeficiency, it is recommended to update the current warning. 
Z namenom, da se izboljša trenutno opozorilo o dajanju cepiva Rotarix dojenčkom z znano ali s sumom na imunsko pomanjkljivost, se priporoča posodobitev trenutnega opozorila.
Rotarix may be given according to the same vaccination course to infants who were born prematurely, provided that the pregnancy had lasted at least 27 weeks. 
Pri nedonošenčkih se lahko cepivo Rotarix uporabi po enakem razporedu cepljenja, pod pogojem, da je nosečnost trajala vsaj 27 tednov.
Clinical protection was assessed in the ATP cohort for efficacy, which includes all subjects from the ATP cohort for safety who entered into the concerned efficacy follow-up period. 
Klinična zaščita je bila ocenjena v kohorti po protokolu za učinkovitost, ki vključuje vse preiskovance iz kohorte po protokolu za varnost, vključene v zadevno obdobje spremljanja učinkovitosti.
Protective efficacy in Latin America 
Učinkovitost zaščite v Latinski Ameriki
Position the child to give the vaccine • Seat the child leaning slightly backwards. 
Namestite otroka za dajanje cepiva • Posedite otroka tako, da bo nagnjen rahlo nazaj.
The safety profile was similar between Rotarix and placebo recipients. 
Varnostni profil je bil pri prejemnikih cepiva Rotarix in placeba podoben.
• You may need to squeeze the tube a few times to get all of the vaccine out - it is okay if a drop remains in the tip of the tube. 
• Tubo boste morda morali nekajkrat stisniti, da boste iztisnili celotno cepivo - povsem v redu je, če kapljica ostane v konici tube.
The two doses of the vaccine must have been given by the age of 24 weeks, although they should preferably have been given before 16 weeks of age. 
Oba odmerka cepiva mora prejeti, preden dopolni 24 tednov, najbolje pa je, da ju prejme že pred dopolnjenim 16. tednom starosti.
Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception. 
Osebe z nekorigirano kongenitalno malformacijo gastrointestinalnega trakta, ki je lahko predispozicija za invaginacijo.
In a retrospective database study in Belgium conducted in children 5 years of age and younger, the direct and indirect impact of Rotarix vaccination on rotavirus-related hospitalisation ranged from 64% (95% CI: 49;76) to 80% (95% CI: 77;83) two years after vaccine introduction. 
V retrospektivni študiji podatkovne baze v Belgiji, izvedene pri otrocih, starih 5 let ali manj, je neposredni in posredni vpliv cepljenja s cepivom Rotarix na hospitalizacije, povezane z rotavirusi, dve leti po uvedbi cepiva segal od 64 % (95 % IZ: 49, 76) do 80 % (95 % IZ: 77, 83).
• blood in stools 
• kri v blatu
If you forget to go back to your doctor at the scheduled time, ask your doctor for advice. 
Če ste na predvideni obisk pozabili, se posvetujte z zdravnikom.
• if your child has a severe infection with a high temperature. 
• če ima hujšo okužbo s povišano telesno temperaturo.
Rotarix is a clear and colourless liquid. 
Cepivo Rotarix je bistra in brezbarvna tekočina.
No increase in the incidence or severity of these events was seen with the second dose. 
Po aplikaciji drugega odmerka se pojavnost ali resnost omenjenih učinkov ni povečala.
Rotarix may be given with the same posology to preterm infants born after at least 27 weeks of gestational age (see sections 4.8 and 5.1). 
Enako odmerjanje cepiva Rotarix lahko uporabimo pri nedonošenčkih, rojenih po vsaj 27 tednih gestacijske starosti (glejte poglavji 4.8 in 5.1).
What Rotarix is and what it is used for 
Kaj je cepivo Rotarix in za kaj ga uporabljamo
This product contains sucrose 1,073 mg (see section 4.4). 
Cepivo vsebuje 1.073 mg saharoze (glejte poglavje 4.4).
• Hold the side of tube 
• Držite stranico tube.
To open the separated oral tube: d) Keep the separated oral tube held upright. 
Odpiranje ločene tube: d) Ločeno tubo držite pokončno.
As a precaution, healthcare professionals should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever) since data from observational safety studies indicate an increased risk of intussusception, mostly within 7 days after rotavirus vaccination (see section 4.8). 
Zdravstveno osebje mora, kot previdnostni ukrep, spremljati vse simptome, ki kažejo na invaginacijo (hude bolečine v trebuhu, dolgotrajno bruhanje, krvavo blato, napihnjenost trebuha in/ali močno zvišano telesno temperaturo), saj podatki iz opazovalnih varnostnih študij kažejo povečano tveganje za invaginacijo, večinoma v 7 dneh po cepljenju s cepivom proti rotavirusu (glejte poglavje 4.8).
Check the expiry date on the connecting bar. 2. 
Preverite datum roka uporabnosti na povezovalni ploščici.
How Rotarix works: 
Kako cepivo Rotarix deluje:
Press the cap down to pierce the membrane. 
Pritisnite zaporko navzdol, da prebodete membrano.
• You may need to squeeze the oral tube a few times to get all of the vaccine out - it is okay if a drop stays in the oral tube. 
• Tubo boste morda morali nekajkrat stisniti, da boste iztisnili celotno cepivo - povsem v redu je, če kapljica ostane v tubi.
The extent of protection that Rotarix might provide against other rotavirus strains that have not been circulating in clinical trials is currently unknown. 
Obseg morebitne zaščite, dosežene s cepivom Rotarix, proti drugim rotavirusnim sevom, ki med kliničnimi preskušanji niso krožili, trenutno ni znan.
These antibodies protect against disease caused by these types of rotavirus. 
Protitelesa ščitijo pred boleznijo, ki jo povzročajo ti serotipi rotavirusov.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, zasoplost in otekanje obraza ali jezika;
If the reconstituted vaccine is to be stored temporarily before administration, replace the protective tip cap on the oral applicator. 
Če rekonstituirano cepivo pred aplikacijo začasno shranite, na peroralni aplikator namestite zaščitni pokrovček.
• This vaccine is given orally straight from an individual tube. 
• To cepivo se daje peroralno - neposredno iz posamezne tube.
51% (95% CI: 26;67, El Salvador) to 60% (95% CI: 37; 75, Brazil). 
51 % (95 % IZ: 26;67 v El Salvadorju) do 60 % (95 % IZ: 37;75 v Braziliji).
In a total of four clinical trials, approximately 3,800 doses of Rotarix liquid formulation were administered to approximately 1,900 infants. 
V skupaj štirih kliničnih preskušanjih so uporabili približno 3.800 odmerkov tekoče oblike cepiva Rotarix pri približno 1.900 dojenčkih.
The use of Rotarix should be based on official recommendations. 
Cepivo Rotarix se sme uporabljati le v skladu z uradnimi priporočili.
Despite a low reporting rate of urticaria events (i.e. 0.013 cases per 100,000 doses distributed), some spontaneous cases suggested a possible association between Rotarix vaccination and urticaria. 
0,013 primerov na 100.000 distribuiranih odmerkov) nekateri spontano poročani primeri kažejo možno povezavo med cepljenjem s cepivom Rotarix in urtikarijo.
The signs may include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever. 
Med znaki so lahko hude bolečine v trebuhu, dolgotrajno bruhanje, kri v blatu, napihnjen trebuh in/ali močno zvišana telesna temperatura.
Protective efficacy in Africa 
Učinkovitost zaščite v Afriki
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The following side effects may happen with this vaccine: 
Pri tem cepivu lahko pride do naslednjih neželenih učinkov:
Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccinees have been observed without causing any clinical symptom. 
Poročali so o prenašanju izločenega vakcinalnega virusa na seronegativne osebe, ki so bile v stiku s cepljeno osebo, pri čemer pa se klinični simptomi niso pojavili.
The immunologic mechanism by which Rotarix protects against rotavirus gastro-enteritis is not completely understood. 
Imunološki mehanizem, s katerim cepivo Rotarix ščiti pred rotavirusnim gastroenteritisom, ni popolnoma pojasnjen.
There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa. 
Podatki o varnosti, imunogenosti in učinkovitosti cepljenja v primerih, ko je za prvi odmerek uporabljeno cepivo Rotarix, za drugi odmerek pa drugo cepivo proti rotavirusom ali obratno, niso na voljo.
For subjects with a predisposition for intussusception, see section 4.3. 
Za osebe z nagnjenostjo k invaginaciji glejte poglavje 4.3.
† Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale * Not statistically significant (p ≥ 0.05). 
† Hud gastroenteritis je bil opredeljen kot ocena ≥ 11 na Vesikarijevi lestvici * Ni statistično značilno (p ≥ 0,05).
Vaccine efficacy was 100% (95% CI: 67.5; 100). 
Učinkovitost cepiva je bila 100 % (95 % IZ: 67,5; 100).
Protective efficacy in Europe 
Učinkovitost zaščite v Evropi
As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the rotavirus infections it is intended to prevent. 
Kot velja za vsa cepiva, tudi cepivo Rotarix morda ne bo popolnoma zaščitilo vseh cepljenih oseb pred okužbami z rotavirusi.
Concomitant administration of Rotarix and oral polio vaccine (OPV) does not affect the immune response to the polio antigens. 
Pri sočasni aplikaciji cepiva Rotarix in peroralnega cepiva proti otroški ohromelosti (OPV) se imunski odziv na polio antigene ne spremeni.
1 dose (1.5 ml) 
1 odmerek (1,5 ml)
* In these studies, the point estimates and confidence intervals were respectively: 100% (95% CI:1,858.0;100), 100% (95% CI: 21.1;100), 45.4% (95% CI: -81.5;86.6), 74.7 (95% CI :-386.2;99.6). 
100 % (95 % IZ: -1.858,0; 100), 100 % (95 % IZ: 21,1; 100), 45,4 % (95 % IZ: -81,5; 86,6) in 74,7 % (95 % IZ: -386,2; 99,6).
Adverse reactions reported are listed according to the following frequency: 
Tabelarični pregled neželenih učinkov Poročane neželene učinke so razvrstili glede na naslednjo pogostnost:
Under no circumstance should this vaccine be administered by injection. 
To cepivo se v nobenem primeru ne sme injicirati.
Put back in fridge immediately 
Takoj vrnite v hladilnik
Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency (SCID) disorder 
gastroenteritis z izločanjem cepilnega virusa pri dojenčkih s hudo kombinirano imunsko pomanjkljivostjo (SCID)
Safety in infants with human immunodeficiency (HIV) infection In a clinical study, 100 infants with HIV infection were administered Rotarix or placebo. 
Varnost pri dojenčkih, okuženih s HIV (virusom humane imunske pomanjkljivosti) V klinični študiji je 100 dojenčkov, okuženih s HIV, dobilo cepivo Rotarix ali placebo.
No data are available on the use of Rotarix for post-exposure prophylaxis. 
Podatki o uporabi cepiva Rotarix za postekspozicijsko profilakso niso na voljo.
Read the instructions before administration of the vaccine. 
Pred uporabo cepiva preberite navodila.
There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses or growth retardation. 
Podatki o varnosti in učinkovitosti cepiva Rotarix pri otrocih z boleznimi prebavil ali zavrto rastjo niso na voljo.
• he/she has not been gaining weight and growing as expected. 
• se telesna masa otroka ali rast ne povečujeta v skladu s pričakovanji;
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix. 
Dokazi, pridobljeni med kliničnimi preskušanji kažejo, da dojenje ne zmanjša zaščite pred rotavirusnim gastroenteritisom, ki se jo doseže s cepivom Rotarix.
For instructions for administration, see section 6.6. 
Za navodila pred dajanjem glejte poglavje 6.6.
Those trials have shown that the safety profile of the liquid formulation is comparable to the lyophilised formulation. 
Ta preskušanja so pokazala, da so varnostne značilnosti tekoče oblike podobne kot pri liofilizirani obliki.
Impact studies with Rotarix conducted in Panama, Brazil and Mexico showed a decrease in all-cause diarrhoea mortality ranging from 17% to 73% in children less than 5 years of age, within 2 to 4 years after vaccine introduction. 
Študije vpliva s cepivom Rotarix v Panami, Braziliji in Mehiki so pokazale, da se je v 2 do 4 letih po uvedbi cepiva umrljivost zaradi driske zaradi vseh vzrokov pri otrocih, mlajših od 5 let, zmanjšala od 17 % do 73 %.
LIST OF EXCIPIENTS Powder: sucrose, sorbitol See the package leaflet for further information 
SEZNAM POMOŽNIH SNOVI Prašek: saharoza, sorbitol Za dodatne informacije glejte navodilo za uporabo.
Side effects that have been reported during marketed use of Rotarix include: 
Med neželenimi učinki, opisanimi med obdobjem, ko je cepivo Rotarix na trgu, so:
The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or diarrhoea. 
Znaki gastroenteritisa lahko vključujejo slabost, bruhanje, želodčne krče ali drisko.
Severe† 
Hud†
D. Store remaining doses in the fridge immediately 
D. Neporabljene odmerke takoj shranite nazaj v hladilnik
6.6 Special precautions for disposal and other handling The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration. 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Cepivo je bistra in brezbarvna tekočina brez vidnih delcev za peroralno uporabo.
There are no restrictions on the infant's consumption of food or liquid, either before or after vaccination. 
Glede uživanja hrane ali tekočine pred ali po aplikaciji cepiva ni omejitev.
When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the most commonly occurring types of rotavirus. 
Po cepljenju imunski sistem (obrambni mehanizem telesa) ustvari protitelesa proti najpogostejšim serotipom rotavirusov.
Section 4.4 of the SmPC of Rotarix includes a warning on administration of Rotarix to infants who have known or suspected immunodeficiency. 
V poglavju 4.4 SmPC-ja cepiva Rotarix je opozorilo o dajanju cepiva Rotarix dojenčkom z znano ali s sumom na imunsko pomanjkljivost.
Official batch release: 
Uradna sprostitev serije:
PHARMACEUTICAL FORM AND CONTENTS Oral suspension 
FARMACEVTSKA OBLIKA IN VSEBINA Peroralna suspenzija
Hypersensitivity after previous administration of rotavirus vaccines. 
Preobčutljivost po predhodni aplikaciji cepiv proti rotavirusom.
If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, contact your doctor before receiving this vaccine. 
Če veste, da vaš otrok ne prenaša določenih sladkorjev, o tem obvestite zdravnika, preden otrok prejme cepivo.
Instructions for reconstitution and administration of the vaccine: 
Navodila za rekonstitucijo in aplikacijo cepiva:
US 
ZDA
2, 3 to 4 months 
2. in 3. do 4. mesec
To open the tube 
Odpiranje tube
Check the membrane has been pierced 
Preverite, da ste prebodli membrano
The solvent is a turbid liquid with a slow settling white deposit and a colourless supernatant. 
Vehikel je motna tekočina s počasi usedajočo se belo usedlino in brezbarvnim supernatantom.
• Check the liquid is clear and colourless, without any particles in it. 
• Preverite, da je tekočina bistra in brezbarvna ter da v njej ni delcev.
Rotarix contains sucrose and sorbitol 
Cepivo Rotarix vsebuje saharozo in sorbitol
In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit. 
Če otrok izpljune ali regurgitira večino odmerka cepiva, lahko ob istem obisku prejme še en nadomestni odmerek.
(6) In subjects who did not receive the full course of vaccination, the effectiveness after one dose ranged from 51% (95% CI: 26;67, El Salvador) to 60% (95% CI: 37;75, Brazil). 
(6) Med preiskovanci, ki niso prejeli celotnega zaporedja cepljenja, je bila učinkovitost po enem odmerku v razponu od 51 % (95 % IZ: 26;67 v El Salvadorju) do 60 % (95 % IZ: 37;75 v Braziliji).
As always, please take care to wash your hands thoroughly after changing soiled nappies. 
Po vsakem menjavanju plenic si temeljito umijte roke.
There are no data on the use of Rotarix during pregnancy and lactation. 
O uporabi cepiva Rotarix med nosečnostjo in dojenjem ni podatkov.
The shaken suspension will appear as a turbid liquid with a slow settling white deposit 
Pretresena suspenzija je motna tekočina s počasi usedajočo se belo usedlino.
The vaccine efficacy against severe rotavirus gastro-enteritis during the first year of life was 61.2% (95% CI: 44.0;73.2). 
Učinkovitost cepiva proti hudemu rotavirusnemu gastroenteritisu v prvem letu življenja je bila 61,2 % (95 % IZ: 44,0;73,2).
- This vaccine has been prescribed for your child only. 
- Cepivo je bilo predpisano vašemu otroku osebno in ga ne smete dajati drugim.
Malawi 
Malavi
Safety in preterm infants 
Varnost pri nedonošenčkih
The protective vaccine efficacy against severe rotavirus (RV) gastro-enteritis requiring hospitalisation and/or rehydration therapy in a medical facility and the genotype specific vaccine efficacy after two doses of Rotarix are presented in the table below: 
Učinkovitost zaščite cepiva proti hudemu rotavirusnemu (RV) gastroenteritisu, pri katerem je potreben sprejem v bolnišnico in/ali rehidracijsko zdravljenje v zdravstvenih ustanovah, in genotipsko specifična učinkovitost cepiva po prejemu dveh odmerkov cepiva Rotarix sta predstavljeni v spodnji preglednici:
Protective efficacy of the liquid formulation 
Učinkovitost zaščite tekoče oblike cepiva
Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person. 
Rotavirusi se po stiku z blatom okužene osebe preko rok zlahka zanesejo v usta.
Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for rotavirus vaccine monovalent (live, oral) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing rotavirus vaccine monovalent (live, oral) is unchanged subject to the proposed changes to the product information The CHMP recommends that the terms of the marketing authorisation(s) should be varied. 
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za cepivo proti rotavirusom, živo odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) cepivo proti rotavirusom, živo nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Administration of Rotarix may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk. 
O dajanju cepiva Rotarix takšnim otrokom mora zdravnik skrbno razmisliti, še posebej, če meni, da bi bilo necepljenje povezano z večjim tveganjem.
♦ Common (These may occur with up to 1 in 10 doses of the vaccine): 
♦ Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 na 10 odmerkov cepiva):
Intussusception (see section 4.4) 
Zelo redki invaginacija (glejte poglavje 4.4)
Ask your pharmacist how to throw away medicines your child no longer uses. 
O načinu odstranjevanja cepiva, ki ga vaš otrok ne potrebuje več, se posvetujte s farmacevtom.
The vaccine (1.5 ml liquid) will be given orally. 
Otrok bo cepivo (1,5 ml tekočine) prejel peroralno (skozi usta).
Rotarix is available in a pack of 1, 5, 10 or 25. 
Cepivo Rotarix je na voljo v pakiranjih po 1, 5, 10 ali 25.
Instructions for administration of the vaccine in a pre-filled oral applicator: 
Navodila za aplikacijo cepiva v napolnjenem peroralnem aplikatorju:
However, some children become very ill with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation. 
Večina otrok z rotavirusno drisko ozdravi sama po sebi, nekateri otroci pa resno zbolijo in močno bruhajo, imajo hudo drisko, pojavi pa se lahko tudi smrtno nevarna izguba tekočin, ki zahteva sprejem v bolnišnico.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI) ODGOVOREN (ODGOVORNI)