FrancophonIA/ELRC3.0 huggingface dataset:
English: If your child has already been infected with rotavirus but is not yet ill when vaccinated, RotaTeq may not be able to prevent the illness.
Slovenian: Če se je vaš otrok z rotavirusi že okužil, vendar pa ob cepljenju še ni bil bolan, cepivo RotaTeq morda ne bo moglo preprečiti bolezni.
English: Under no circumstance should this vaccine be administered by injection.
Slovenian: V nobenem primeru se tega cepiva ne sme vbrizgati z injekcijo.
English: The protective efficacy of RotaTeq was evaluated in two ways in the placebo-controlled Rotavirus Efficacy and Safety Trial (REST):
Slovenian: Zaščitna učinkovitost cepiva RotaTeq je bila v s placebom nadzorovanem preskušanju “Rotavirus Efficacy and Safety Trial” (REST) ovrednotena na dva načina:
English: FOR ORAL USE ONLY Read the package leaflet before use
Slovenian: SAMO ZA PERORALNO UPORABO Pred uporabo preberite priloženo navodilo!
English: EU/1/06/348/001 pack of 1 tube EU/1/06/348/002 pack of 10 tubes
Slovenian: EU/1/06/348/001 škatla z 1 tubo EU/1/06/348/002 škatla z 10 tubami
English: Adverse reactions more common in the vaccine group in clinical trials are listed below per system organ class and frequency.
Slovenian: Neželeni učinki, ki so bili v kliničnih preskušanjih pogostejši v skupini, ki je dobila cepivo, so spodaj razvrščeni glede na organski sistem in pogostnost.
English: It is important that you follow the instructions of your doctor/health care professional regarding your child's return visits for the follow-up doses.
Slovenian: Pomembno je, da upoštevate navodila zdravnika ali drugega zdravstvenega osebja glede ponovnih obiskov zaradi prejema nadaljnjih odmerkov cepiva.
English: Instructions
Slovenian: Navodila
English: RotaTeq SHOULD UNDER NO CIRCUMSTANCES BE INJECTED.
Slovenian: CEPIVA RotaTeq SE V NOBENEM PRIMERU NE SME INJICIRATI.
English: 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.
Slovenian: V primeru, da vaš otrok večino odmerka cepiva izpljune ali izbruhne, lahko ob istem obisku dobi še en nadomestni odmerek.
English: Discard the empty tube and cap in approved biological waste containers according to local regulations.
Slovenian: Prazno tubo in zaporko odvrzite v predpisan zabojnik za biološke odpadke v skladu z lokalnimi predpisi.
English: Asymptomatic HIV infection is not expected to affect the safety or efficacy of RotaTeq.
Slovenian: Ne pričakujemo, da bi asimptomatska okužba s HIV vplivala na varnost in učinkovitost cepiva RotaTeq.
English: There is limited evidence of a smaller increased risk following the second dose.
Slovenian: O manjšem povečanju tveganja po drugem odmerku je malo podatkov.
English: Post-marketing adverse events (frequency cannot be estimated from the available data).
Slovenian: Stranski učinki v obdobju trženja zdravila (pogostosti ni mogoče oceniti iz razpoložljivih podatkov)
English: The presence of a minor infection is not a contraindication for immunisation.
Slovenian: Blaga okužba ni kontraindikacija za cepljenje.
English: Country:
Slovenian: Država:
English: RotaTeq with food and drink
Slovenian: Cepivo RotaTeq skupaj s hrano in pijačo
English: The first dose (2 ml) of RotaTeq may be given from the age of 6 weeks and should be given before 12 weeks of age (about 3 months).
Slovenian: Prvi odmerek (2 ml) cepiva RotaTeq lahko otrok prejme, ko je star 6 tednov, mora pa ga prejeti, preden je star 12 tednov (približno 3 mesece).
English: As always, please take care to wash your hands thoroughly after changing soiled nappies.
Slovenian: Tako kot vedno si po previjanju dojenčka temeljito umijte roke.
English: This adverse reaction was identified through post-marketing surveillance.
Slovenian: Ta neželeni učinek so odkrili med spremljanjem v obdobju trženja.
English: • Bronchospasm (rare, may affect up to 1 in 1000 infants).
Slovenian: • Bronhospazem (redek, pojavi se lahko pri največ 1 od 1.000 dojenčkov).
English: Read all of this leaflet carefully before your child is vaccinated because it contains important information for you.
Slovenian: Preden bo vaš otrok prejel cepivo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: * Severe defined as a score >16/24 using a validated clinical scoring system based on the intensity and duration of symptoms (fever, vomiting, diarrhoea and behavioural changes) Statistically significant
Slovenian: * Huda bolezen je definirana z rezultatom > 16/24 pri uporabi potrjenega kliničnega ocenjevalnega sistema na osnovi intenzitete in trajanja simptomov (zvišana telesna temperatura, bruhanje, driska in vedenjske spremembe).
English: Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, The Netherlands
Slovenian: Izdelovalec, odgovoren za sproščanje serij: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, Nizozemska
English: The first dose was administered from 6 weeks after birth.
Slovenian: Prvi odmerek so prejeli od 6 tednov po rojstvu dalje.
English: • Severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever.
Slovenian: • Huda bolečina v želodcu, ponavljajoče bruhanje, kri v blatu, otekel trebuh in/ali zvišana telesna temperatura.
English: The additional data from the FES increased the number by 136 encounters in total, including 9 in the vaccine group and 127 in the placebo group.
Slovenian: Po dodatnih podatkih iz FES se je to število povečalo za skupno 136 (9 v skupini, ki je prejela cepivo, in 127 v skupini, ki je prejela placebo).
English: Although concomitant administration of OPV slightly reduced the immune response to rotavirus vaccine, there is currently no evidence that clinical protection against severe rotavirus gastroenteritis would be affected.
Slovenian: Čeprav je sočasna uporaba OPV neznatno znižala imunski odziv na cepivo proti rotavirusu, zaenkrat ni dokazov o tem, da bi se spremenila klinična zaščita pred resnim rotavirusnim gastroenteritisom.
English: These antibodies help protect against gastroenteritis caused by these types of rotavirus.
Slovenian: Ta protitelesa pomagajo ščititi pred gastroenteritisom, ki ga povzročajo ti tipi rotavirusov.
English: 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 studies indicate an increased risk of intussusception, mostly within 7 days after rotavirus vaccination (see section 4.8).
Slovenian: Zdravstveno osebje mora iz previdnosti spremljati vse simptome, ki bi lahko kazali na invaginacijo (hude bolečine v trebuhu, ponavljajoče bruhanje, kri v blatu, napihnjen trebuh in/ali zvišana telesna temperatura), saj so podatki iz opazovalnih študij pokazali povečano tveganje za invaginacijo, večinoma v 7 dneh po cepljenju s cepivom Rotateq (glejte poglavje 4.8).
English: It is preferable that the vaccination course of three doses should be completed by the age of 20-22 weeks.
Slovenian: Cepljenje s tremi odmerki je najbolje zaključiti do starosti 20-22 tednov.
English: In REST there were 403 healthcare encounters (20 in the vaccine group and 383 in the placebo group) associated with G1-G4 and G9 RV gastroenteritis in the per protocol population.
Slovenian: V študiji REST je bilo 403 obiskov zdravnika (20 v skupini, ki je prejela cepivo, in 383 v skupini, ki je prejela placebo), povezanih z G1-G4 in G9 RV gastroenteritisom v populaciji po protokolu.
English: Also, those caring for recent vaccinees should observe careful hygiene especially when handling excreta.
Slovenian: Osebe, ki skrbijo za otroka, ki je bil pred kratkim cepljen, se morajo držati stroge higiene, še posebej pri rokovanju z izločki.
English: However, 19 of the approximately 1,000 infants were born at a gestational age of 25 to 28 weeks, 55 were born at a gestational age of 29 to 31 weeks and the remainder was born at a gestational age of between 32 and 36 weeks.
Slovenian: V tej študiji je bilo 19 od približno 1.000 nedonošenčkov rojenih od 25. do 28. tedna nosečnosti, 55 jih je bilo rojenih od 29. do 31. tedna nosečnosti, preostali nedonošenčki pa so bili rojeni od 32. do 36. tedna nosečnosti.
English: What RotaTeq is and what it is used for
Slovenian: Kaj je cepivo RotaTeq in za kaj ga uporabljamo
English: Hospitalization and ED visits due to all cause gastroenteritis
Slovenian: hospitalizacija in obiski nujne medicinske pomoči zaradi katerega koli vzroka gastroenteritisa
English: Infants who have known or suspected immunodeficiency (see sections 4.4 and 4.8).
Slovenian: Dojenčki z znanim pomanjkljivim imunskim odzivom ali sumom nanj (glejte poglavji 4.4 in 4.8).
English: To administer the vaccine:
Slovenian: Aplikacija cepiva:
English: What you need to know before your child receives RotaTeq
Slovenian: Kaj morate vedeti, preden bo vaš otrok prejel cepivo RotaTeq
English: Outpatients due to RVGE
Slovenian: ambulantno zdravljenje zaradi RVGE
English: One dose (2 ml) contains rotavirus type*: G1
Slovenian: En odmerek (2 ml) vsebuje rotaviruse tipa*: G1
English: The vaccine will be given by gently squeezing the tube and delivering the vaccine into your child's mouth.
Slovenian: Cepivo bo dal-a tako, da bo iz tube cepivo nežno iztisnil-a v otrokova usta.
English: - has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system.
Slovenian: - če je vaš otrok v tesnem stiku z osebo (npr. v skupnem gospodinjstvu), ki ima oslabljen imunski sistem, npr. z osebo z rakom ali z osebo, ki se zdravi z zdravili, ki lahko oslabijo imunski sistem.
English: Efficacy in premature infants
Slovenian: Učinkovitost pri nedonošenčkih
English: In addition, there was no statistically significant increased risk of this adverse event during the 0-30 day follow-up period compared with a concurrent control group of infants who received DTaP, but not RotaTeq (n=62,617, 12,339 person-years of follow-up).
Slovenian: Poleg tega v obdobju spremljanja 0-30 dni po cepljenju ni bilo statistično značilnega povečanja tveganja za ta neželeni dogodek v primerjavi s pripadajočo kontrolno skupino dojenčkov, ki so prejeli cepivo DTaP in ne cepiva RotaTeq (n = 62.617; spremljanje je trajalo 12.339 oseb-let).
English: As with all vaccines, appropriate medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine (see section 4.8).
Slovenian: Kot pri vseh cepivih mora biti na voljo ustrezno zdravljenje za primer anafilaktične reakcije po aplikaciji cepiva (glejte poglavje 4.8).
English: However, post hoc analyses indicated that RotaTeq achieved some reduction in the numbers of cases of rotavirus gastroenteritis of sufficient severity to require hospitalisation or an emergency department visit before completion of all three doses (i.e. from approximately 14 days after administration of the first dose onwards).
Slovenian: Vendar pa so naknadne analize pokazale, da so s cepivom RotaTeq nekoliko zmanjšali število primerov rotavirusnega gastroenteritisa, dovolj hudega, da je zahteval hospitalizacijo ali obisk nujne zdravniške pomoči, dosegli že pred zaključkom cepljenja z vsemi tremi odmerki (to je od približno 14. dneva po prvem odmerku).
English: Data from observational safety studies performed in several countries indicate that rotavirus vaccines carry an increased risk of intussusception, with up to 6 additional cases per 100,000 infants within 7 days of vaccination.
Slovenian: Podatki iz opazovalnih študij varnosti, izvedenih v več državah, so za cepiva proti rotavirusom pokazali tudi do 6 dodatnih primerov invaginacije na 100.000 dojenčkov v 7 dneh po cepljenju, kar kaže na povečano tveganje za pojav invaginacije.
English: If you forget or are not able to go back to your doctor/health care professional at the scheduled time, ask him or her for advice.
Slovenian: Če ste na dogovorjeni obisk pozabili ali pa niste mogli priti ob načrtovanemu času, se posvetujte z zdravnikom/drugim zdravstvenim osebjem.
English: tube label
Slovenian: nalepka na tubi
English: These could be symptoms of a very rare (may affect up to 1 in 10,000 infants), but serious, side effect called intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).
Slovenian: To so lahko simptomi zelo redkega (pojavi se lahko pri največ 1 od 10.000 dojenčkov), a resnega neželenega učinka, imenovanega invaginacija (zaprtje črevesja, pri čemer se en del črevesja uviha v drugi del črevesja).
English: Do not use this vaccine after the expiry date which is stated on the label after EXP.
Slovenian: Tega cepiva ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: In trials, RotaTeq was shed in the stools of 8.9 % of vaccine recipients almost exclusively in the week after dose 1 and in only one vaccine recipient (0.3 %) after dose 3.
Slovenian: V preskušanjih se je cepivo RotaTeq z blatom izločalo pri 8,9 % cepljenih osebah skoraj izključno v tednu po prejemu 1. odmerka, po prejemu 3. odmerka pa le pri eni osebi (0,3 %).
English: The vaccine induces an immune response (i.e., appearance of serum neutralising antibody) to the five human-rotavirus proteins expressed on the reassortants (G1, G2, G3, G4 and P[8]).
Slovenian: Cepivo sproži imunski odziv (tj. pojav serumskih nevtralizirajočih protiteles) na pet humanih rotavirusnih proteinov, vključenih v reasortirane rotaviruse (G1, G2, G3, G4 in P[8]).
English: If it is observed or strongly suspected that an incomplete dose has been swallowed (e.g., infant spits or regurgitates the vaccine), a single replacement dose may be given at the same vaccination visit, however, this has not been studied in clinical trials.
Slovenian: Če opazite ali mislite, da otrok ni pogoltnil celega odmerka (npr. če otrok cepivo izpljune ali izbruhne), mu lahko ob istem obisku daste en nadomestni odmerek, vendar pa to v kliničnih preskušanjih ni bilo preučeno.
English: Kawasaki disease was reported in 5 of 36,150 vaccine recipients (<0.1 %) and 1 of 35,536 placebo recipients (<0.1 %) with a relative risk (RR) of 4.9 [95 % CI, 0.6 - 239.1] (not statistically significant).
Slovenian: O Kawasakijevi bolezni so poročali pri 5 od 36.150 prejemnikov cepiva (< 0,1 %) in pri 1 od 35.536 prejemnikov placeba (< 0,1 %) z relativnim tveganjem 4,9 [95-odstotni IZ, 0,6-239.1]
English: The vaccine can be given without regard to food, liquid, or breast milk.
Slovenian: Cepivo se lahko daje ne glede na hrano, pijačo ali materino mleko.
English: The immunological mechanism by which RotaTeq protects against rotavirus gastroenteritis is not completely understood.
Slovenian: Imunološki mehanizem, s katerim cepivo RotaTeq ščiti pred rotavirusnim gastroenteritisom, ni popolnoma pojasnjen.
English: The extent of protection that RotaTeq might provide against other rotavirus types and in other populations is unknown.
Slovenian: Stopnja zaščite, ki se jo lahko doseže s cepivom RotaTeq proti drugim tipom rotavirusov in pri drugih populacijah, ni znana.
English: Your child will receive 3 doses of RotaTeq given at least four weeks apart.
Slovenian: Otrok bo prejel 3 odmerke cepiva RotaTeq v vsaj štiri-tedenskih presledkih.
English: Safety or efficacy data are not available for infants with active gastrointestinal illnesses (including chronic diarrhoea) or growth retardation.
Slovenian: Podatkov o varnosti in učinkovitosti cepiva pri otrocih z aktivno boleznijo prebavil (vključno s kronično drisko) ali otrocih z zavrto rastjo ni na voljo.
English: 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.
Slovenian: Pri veliko prezgodaj rojenih dojenčkih (rojenih v 28. tednu nosečnosti ali prej) so lahko 2-3 dni po cepljenju presledki med vdihi daljši, kot je normalno.
English: • Uncommon (may affect up to 1 in 100 infants): stomach pains (see also above for signs of a very rare side effect of intussusception), runny nose and sore throat, ear infection, rash, blood in stool
Slovenian: • občasni (pojavijo se lahko pri največ 1 od 100 dojenčkov): bolečine v želodcu (glejte tudi zgoraj glede znakov zelo redkega neželenega učinka, imenovanega invaginacija), izcedek iz nosu in vnetje žrela, okužba ušesa, izpuščaj, kri v blatu
English: - your child is allergic to any of the components of this vaccine (see section 6 Contents of the pack and other information).
Slovenian: - če je alergičen na katero koli sestavino tega cepiva (glejte poglavje 6.
English: Reduction in hospitalisations and emergency department visits for RV gastroenteritis for up to 2 years post-vaccination (RotaTeq n=34,035) (% [95 % CI])
Slovenian: Zmanjšanje števila sprejemov v bolnišnico/obiskov enot za nujno medicinsko pomoč zaradi RV gastroenteritisa v času do dveh let po cepljenju (RotaTeq n = 34.035) (% [95-odstotni IZ])
English: Administration of RotaTeq may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.
Slovenian: Uporaba cepiva RotaTeq lahko pride v poštev tudi pri teh otrocih, še posebej, če po mnenju zdravnika necepljenje predstavlja večje tveganje.
English: The most commonly reported adverse reactions that occurred more frequently with vaccine than with placebo were pyrexia (20.9 %), diarrhoea (17.6 %) and vomiting (10.1 %).
Slovenian: Neželeni učinki, o katerih so poročali najpogosteje in so bili po prejemu cepiva RotaTeq pogostejši kot po prejemu placeba, so bili: zvišana telesna temperatura (20,9 %), driska (17,6 %) in bruhanje (10,1 %).
English: Talk to your doctor or pharmacist before using RotaTeq if your child: - has received a blood transfusion or immunoglobulins within the last 6 weeks.
Slovenian: Pred cepljenjem s cepivom RotaTeq se posvetujte z zdravnikom ali farmacevtom: - če je vaš otrok v zadnjih 6 tednih prejel transfuzijo krvi ali imunoglobuline.
English: From 33 weeks to 18 years RotaTeq is not indicated in this subset of paediatric population.
Slovenian: Od 33 tednov do 18 let V tej podskupini pediatrične populacije cepivo RotaTeq ni indicirano.
English: In 5,673 vaccinated infants (2,834 in the vaccine group) protective efficacy was measured as a reduction in the incidence of rotavirus (RV) gastroenteritis caused by vaccine G genotypes (G1G4) that occurred at least 14 days after the third dose of vaccine through the first full rotavirus season after vaccination.
Slovenian: Pri 5.673 cepljenih otrocih (2.834 otrok v skupini, ki je prejemala cepivo) je bila učinkovitost zaščite merjena kot zmanjšanje pojavnosti rotavirusnega (RV) gastroenteritisa, ki so ga povzročili cepilni genotipi G (G1-G4) in ki se je pojavil vsaj 14 dni po prejemu tretjega odmerka cepiva med prvo celotno rotavirusno sezono po cepljenju.
English: Open the dosing tube in 2 easy motions:
Slovenian: Odmerno tubo odprite z 2 preprostima giboma:
English: For subjects with a predisposition for intussusception, see section 4.3.
Slovenian: Pri osebah s predispozicijo za invaginacijo glejte poglavje 4.3.
English: Co-administration resulted in an acceptable safety profile.
Slovenian: Varnosti profil je bil pri sočasni uporabi sprejemljiv.
English: Post-marketing observational safety surveillance study In a large prospective post-marketing observational study in the US, the risk of Kawasaki disease was analysed among 85,150 infants receiving one or more doses of RotaTeq (17,433 person-years of follow-up).
Slovenian: V obsežni opazovalni študiji varnosti v obdobju trženja v ZDA, so tveganje za Kawasakijevo bolezen preučili pri 85.150 dojenčkih, ki so prejeli en ali več odmerkov cepiva RotaTeq (spremljanje je trajalo 17.433 oseb-let).
English: Therefore, RotaTeq can be given concomitantly with monovalent or combination infant vaccines containing one or more of the following antigens: DTaP, Hib, IPV or OPV, HBV, PCV and MenCC.
Slovenian: Zato se lahko cepivo RotaTeq daje sočasno z monovalentnimi ali kombiniranimi otroškimi cepivi, ki vsebujejo enega ali več od naslednjih antigenov: DTaP, Hib, IPV ali OPV, HBV, PCV in MenCC.
English: It is preferred that all three doses should be given by the age of 20-22 weeks and at latest all three doses should be given by the age of 32 weeks.
Slovenian: Najbolje je, da vse tri odmerke cepiva prejme do starosti 20-22 tednov, mora pa jih dobiti vsaj do 32. tedna starosti.
English: The vaccination course consists of three doses.
Slovenian: Cepljenje je treba izvesti s tremi odmerki.
English: A single and repeated dose oral toxicity study in mice suggests no special hazard to humans.
Slovenian: Študije toksičnosti enega samega peroralnega odmerka in ponavljajočih se peroralnih odmerkov, izvedene na miših, ne kažejo posebnega tveganja za človeka.
English: The vaccine contains five types of live rotavirus strains.
Slovenian: Cepivo RotaTeq vsebuje pet tipov živih sevov rotavirusov.
English: rotavirus type* P1A[8]
Slovenian: rotaviruse tipa* P1A[8]
English: United States of America
Slovenian: Združene države Amerike
English: 33,140 vaccinated 26,167 unvaccinated Aged ≥7 months Received 3 doses
Slovenian: 33.140 cepljenih 26.167 necepljenih starih ≥ 7 mesecev prejeti 3 odmerki hospitalizacija in obiski nujne medicinske pomoči zaradi RVGE
English: No safety or efficacy data are available from clinical trials regarding administration of RotaTeq to immunocompromised infants, infants infected with HIV or infants who have received a blood transfusion or immunoglobulins within 42 days of dosing.
Slovenian: Podatkov iz kliničnih preskušanj o varnosti in učinkovitosti cepiva RotaTeq pri otrocih z imunsko pomanjkljivostjo, otrocih, okuženih z virusom HIV, ali otrocih, ki so v 42 dneh pred ali po prejemu odmerka cepiva prejeli transfuzijo krvi ali imunoglobuline, ni na voljo.
English: RotaTeq - Pack size of 1 single-dose (2 ml) Tube RotaTeq - Pack size of 10 single-dose (2 ml) Tubes
Slovenian: RotaTeq - pakiranje z 1 eno-odmerno (2 ml) tubo RotaTeq - pakiranje z 10 eno-odmernimi (2 ml) tubami
English: The safety and efficacy of RotaTeq in individuals from birth to 6 weeks of age have not been established.
Slovenian: Varnost in učinkovitost cepiva RotaTeq pri otrocih od rojstva do 6. tedna starosti nista dokazani.
English: In 68,038 vaccinated infants (34,035 in the vaccine group) protective efficacy was measured as a reduction in the rate of hospitalisations and emergency department visits for RV gastroenteritis from 14 days after the third dose.
Slovenian: Pri 68.038 cepljenih otrocih (34.035 otrok v skupini, ki je prejemala cepivo) je bila učinkovitost zaščite merjena kot zmanjšanje števila sprejemov v bolnišnico in obiskov enot za nujno medicinsko pomoč zaradi RV gastroenteritisa od 14. dneva po tretjem odmerku.
English: If you have been told that your child has an intolerance to some sugars, inform your doctor/health care professional before the vaccine is administered.
Slovenian: Če veste, da vaš otrok ne prenaša določenih sladkorjev, o tem obvestite zdravnika ali drugo zdravstveno osebje, preden otrok prejme cepivo.
English: The active substances in RotaTeq are 5 human-bovine reassortant rotavirus strains: G1 2.2 x 10
Slovenian: Učinkovine cepiva RotaTeq so 5 sevov reasortiranih humano-bovinih rotavirusov: G1 2,2 x 10
English: This Finnish Extension Study (FES) included a subset of 20,736 subjects that had been enrolled previously in REST.
Slovenian: V podaljšek študije na Finskem (FES - Finnish Extension Study) je bilo vključenih 20.736 oseb, ki so bile že prej vključene v študijo REST. Dojenčke so v FES spremljali 3 leta po cepljenju.
English: Keep the dosing tube in the outer carton in order to protect from light.
Slovenian: Odmerno tubo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: RotaTeq may be given without regard to food, liquid, or breast milk.
Slovenian: RotaTeq se lahko daje ne glede na hrano, pijačo ali materino mleko.