FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, malapsorpcijom glukoze-galaktoze ili insuficijencijom saharaze-izomaltaze ne smiju uzimati ovo cjepivo.
English: The safety and efficacy of RotaTeq in individuals from birth to 6 weeks of age have not been established.
Croatian: Sigurnost i djelotvornost cjepiva RotaTeq u pojedinaca u dobi od rođenja do 6 tjedana nisu ustanovljene.
English: From 33 weeks to 18 years RotaTeq is not indicated in this subset of paediatric population.
Croatian: Od 33 tjedna do 18 godina RotaTeq nije indiciran u ovoj podskupini pedijatrijske populacije.
English: Clinical trials of efficacy against rotavirus gastroenteritis were performed in Europe, the United States, Latin America, and Asia.
Croatian: Klinička ispitivanja djelotvornosti cjepiva protiv gastroenteritisa uzrokovanog rotavirusom provedena su u Europi, Sjedinjenim Američkim Državama, Južnoj Americi i Aziji.
English: EU/1/06/348/001 pack of 1 tube EU/1/06/348/002 pack of 10 tubes
Croatian: EU/1/06/348/001 pakiranje od 1 tube EU/1/06/348/002 pakiranje od 10 tuba
English: Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
Croatian: Kao i sva druga cjepiva i lijekovi, ovo cjepivo može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: RotaTeq should be administered promptly after removal from refrigeration.
Croatian: RotaTeq treba primijeniti odmah nakon vađenja iz hladnjaka.
English: The background incidence of intussusception in infants less than one year of age in these countries ranged from 25 to 101 per 100,000 infants per year.
Croatian: Osnovna incidencija intususcepcije u dojenčadi u dobi do jedne godine u tim zemljama kretala se u rasponu od 25 do 101 na 100 000 dojenčadi godišnje.
English: Study population
Croatian: Ispitivana populacija
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.
Croatian: Podaci iz opservacijskih ispitivanja sigurnosti provedenih u nekoliko zemalja pokazuju da cjepiva protiv rotavirusa nose povećan rizik od intususcepcije od čak do 6 dodatnih slučajeva na 100 000 dojenčadi unutar 7 dana od cijepljenja.
English: This may present as wheezing, coughing or difficulty breathing.
Croatian: Može se manifestirati kao piskanje pri disanju, kašljanje ili otežano disanje.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Text for the protective bag
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Tekst na zaštitnoj vrećici
English: * See section 4.4.
Croatian: * Vidjeti dio 4.4.
English: Also, those caring for recent vaccinees should observe careful hygiene especially when handling excreta.
Croatian: Također, osobe koje se brinu za nedavno cijepljenu dojenčad moraju strogo paziti na higijenu, pogotovo pri previjanju uz prisustvo izlučevina.
English: • Bronchospasm (rare, may affect up to 1 in 1000 infants).
Croatian: • Bronhospazam (rijetko, može se javiti u do 1 na 1000 dojenčadi).
English: 6 Infectious Units
Croatian: 6 infektivnih jedinica
English: It is important that your child receives all 3 doses of the vaccine for protection against rotavirus.
Croatian: Važno je da Vaše dijete primi sve 3 doze cjepiva zbog zaštite od rotavirusa.
English: Very common Pyrexia
Croatian: Vrlo često pireksija
English: Asymptomatic HIV infection is not expected to affect the safety or efficacy of RotaTeq.
Croatian: . Ne očekuje se da bi asimptomatska infekcija HIV-om mogla utjecati na sigurnost i djelotvornost cjepiva RotaTeq.
English: It might be necessary to postpone the vaccination until recovery.
Croatian: U tom će slučaju možda biti potrebno odgoditi cijepljenje do potpunog oporavka.
English: The frequency category was estimated based on observational study data.
Croatian: Kategorija učestalosti procijenjena je na temelju podataka iz opservacijskih ispitivanja.
English: Outpatients due to RVGE
Croatian: Ambulantni bolesnici zbog RVGE
English: The vaccine contains five types of live rotavirus strains.
Croatian: Cjepivo sadrži pet tipova živih sojeva rotavirusa.
English: A single and repeated dose oral toxicity study in mice suggests no special hazard to humans.
Croatian: Ispitivanje toksičnosti jednokratne i ponovljenih oralnih doza kod miševa nije ukazalo na poseban rizik za ljude.
English: • Severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever.
Croatian: • Jaka bol u trbuhu, uporno povraćanje, krv u stolici, nadut trbuh i/ili visoka vrućica.
English: Please read the package leaflet for disposal of medicines no longer required
Croatian: Pročitati u uputi o lijeku o uklanjanju lijekova koji više nisu potrebni.
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).
Croatian: Nadalje, rizik od ove nuspojave nije bio statistički značajno povećan tijekom prvih 0-30 dana praćenja u usporedbi s onim u kontrolnoj skupini dojenčadi koja je u tom razdoblju primila DTaP, ali ne i RotaTeq (n=62 617, 12 339 osobagodina praćenja).
English: Efficacy
Croatian: Djelotvornost
English: These infants should receive the first dose of RotaTeq at least six weeks after birth (see sections 4.4 and 5.1).
Croatian: Ova dojenčad treba primiti prvu dozu cjepiva RotaTeq najmanje šest tjedana nakon rođenja (vidjeti dijelove 4.4 i 5.1).
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.
Croatian: Važno je da slijedite upute Vašeg liječnika/zdravstvenog radnika vezane uz ponovni dolazak zbog nastavka cijepljenja.
English: Thus human data on use during pregnancy or lactation are not available and animal fertility or reproduction studies have not been performed.
Croatian: Nema podataka o njegovoj primjeni u trudnoći i za vrijeme dojenja, a istraživanja njegova utjecaja na plodnost i reprodukciju životinja nisu provedena.
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine ATC code: J07BH02.
Croatian: Farmakoterapijska skupina: cjepiva, virusna cjepiva, ATK oznaka: J07BH02.
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.
Croatian: U slučaju da dijete ispljune ili povrati većinu doze cjepiva, zamjenska doza može se dati u istom posjetu liječniku.
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.
Croatian: Dodatni podaci iz FES ispitivanja povisili su broj traženih zdravstvenih usluga za ukupno 136, uključujući 9 u skupini cijepljenoj cjepivom i 127 u placebo skupini.
English: Do not dilute.
Croatian: Ne razrjeđivati.
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).
Croatian: To mogu biti simptomi vrlo rijetke (može se javiti u do 1 na 10 000 dojenčadi), ali ozbiljne nuspojave koja se naziva intususcepcija (začepljenje u crijevu koji nastane kad se jedan dio crijeva uvuče u drugi dio).
English: Safety or efficacy data are not available for infants with active gastrointestinal illnesses (including chronic diarrhoea) or growth retardation.
Croatian: Nisu dostupni podaci o sigurnosti i djelotvornosti cjepiva u dojenčadi s aktivnim gastrointestinalnim bolestima (uključujući kronični proljev) ili sa zastojem u rastu.
English: Overall, 31 % and 25 % of the encounters in the respective groups occurred during the FES.
Croatian: Zaključno, 31% i 25% slučajeva pružanja zdravstvenih usluga bili su zabilježeni tijekom FES ispitivanja u pojedinim skupinama.
English: The level of protection provided by RotaTeq is based on the completion of all 3 doses.
Croatian: Razina zaštite koju osigurava RotaTeq temelji se na primjeni sve 3 doze cjepiva.
English: When an infant is given the vaccine, the immune system (the body's natural defences) will make antibodies against the most commonly occurring types of rotavirus.
Croatian: Kada dojenče dobije cjepivo, njegov imunološki sustav (prirodni mehanizam kojim se tijelo štiti) stvara protutijela protiv najčešćih tipova rotavirusa.
English: There should be intervals of at least 4 weeks between doses.
Croatian: Razdoblje između doziranja treba biti najmanje 4 tjedna.
English: The first dose was administered from 6 weeks after birth.
Croatian: Prvu dozu primili su od 6. tjedna nakon rođenja.
English: RotaTeq should be administered with caution to individuals with close contacts who are immunodeficient (e.g., individuals with malignancies or who are otherwise immunocompromised or individuals receiving immunosuppressive therapy).
Croatian: RotaTeq se mora s oprezom primjenjivati u osoba koje su u bliskom kontaktu s imunodeficijentnim osobama (npr. osobama s malignim bolestima ili drugim imunokompromitiranim osobama ili osobama koje primaju imunosupresivnu terapiju).
English: Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, The Netherlands
Croatian: Proizvođač odgovoran za puštanje serije lijeka u promet: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, Nizozemska
English: 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
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Uncommon Nasopharyngitis, otitis media
Croatian: Manje često nazofaringitis, otitis media
English: Post-marketing adverse events (frequency cannot be estimated from the available data).
Croatian: Nuspojave nakon stavljanja u promet (učestalost se ne može procijeniti iz dostupnih podataka).
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.
Croatian: Ako je Vaše dijete već bilo zaraženo rotavirusom, ali se u vrijeme cijepljenja još nije razboljelo, RotaTeq ga možda neće zaštititi od bolesti.
English: The frequency category was estimated based on relevant clinical trials.
Croatian: Skupina učestalosti procijenjena je na temelju odgovarajućih kliničkih ispitivanja.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Croatian: Blage infekcije poput prehlade ne bi trebale predstavljati problem, ali ipak prvo porazgovarajte sa svojim liječnikom. - ako Vaše dijete ima proljev ili povraća.
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 %).
Croatian: Najčešće prijavljivane nuspojave koje su se češće pojavljivale u dojenčadi na cjepivu, nego li u dojenčadi na placebu, bile su pireksija (20,9%), proljev (17,6%) te povraćanje (10,1%).
English: Study design (Region)
Croatian: Ustroj ispitivanja (regija)
English: Discard the empty tube and cap in approved biological waste containers according to local regulations.
Croatian: Bacite praznu tubu sa zatvaračem u odgovarajuće spremnike za biološki otpad u skladu s nacionalnim propisima.
English: No further doses are recommended after completion of the 3-dose vaccination course (see sections 4.4 and 5.1 regarding available information on persistence of protection).
Croatian: Nakon završetka ciklusa cijepljenja od 3 doze ne preporučuje se naknadno doziranje (vidjeti dijelove 4.4 i 5.1 o dostupnim podacima o trajnosti zaštite).
English: One dose (2 ml) contains rotavirus type*: G1
Croatian: Jedna doza (2 ml) sadrži rotavirus serotipa*: G1
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: As with other vaccines, RotaTeq may not completely protect all children who are vaccinated even after all three doses have been given.
Croatian: Kao i druga cjepiva, RotaTeq ne može u potpunosti zaštititi svu cijepljenu djecu, čak niti nakon što prime sve tri doze cjepiva.
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).
Croatian: Kao i kod svih cjepiva odgovarajuće medicinsko liječenje mora uvijek biti na raspolaganju za slučaj anafilaktičke reakcije nakon primjene cjepiva (vidjeti dio 4.8).
English: For subjects with a predisposition for intussusception, see section 4.3.
Croatian: Za ispitanike sa sklonošću intususcepciji, vidjeti dio 4.3.
English: Claims database analysis (US)
Croatian: Navodi analizu baze podataka (SAD)
English: RotaTeq - Pack size of 1 single-dose (2 ml) Tube RotaTeq - Pack size of 10 single-dose (2 ml) Tubes
Croatian: RotaTeq - pakiranje od 1 jednodozne (2 ml) tube RotaTeq - pakiranje od 10 jednodoznih (2 ml) tuba
English: RotaTeq is available in pack size of 1, 10 dosing tubes.
Croatian: RotaTeq je dostupan u pakiranjima s 1 ili 10 tuba za doziranje.
English: What RotaTeq looks like and contents of the pack
Croatian: Kako RotaTeq izgleda i sadržaj pakiranja
English: This vaccine is contained in a single-dose tube and is a pale yellow clear liquid that may have a pink tint.
Croatian: Cjepivo je pakirano u jednodoznu tubu, a izgleda kao blijedožuta bistra tekućina koja može imati ružičastu nijansu.
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).
Croatian: Kawasakijeva bolest prijavljena je u 5 od 36 150 primatelja cjepiva (<0,1%) te u 1 od 35 536 primatelja placeba (<0,1%) s relativnim rizikom (RR) od 4,9 [95% CI, 0,6-239,1] (nije statistički značajno).
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.
Croatian: Premda je istodobna primjena s OPV-om malo smanjila imunološki odgovor na cjepivo protiv rotavirusa, trenutno nema dokaza da utječe na kliničku zaštitu od teškog gastroenteritisa uzrokovanog rotavirusom.
English: Very common Diarrhoea, vomiting
Croatian: Vrlo često dijareja, povraćanje
English: RotaTeq is to be used on the basis of official recommendations.
Croatian: RotaTeq se treba primjenjivati u skladu sa službenim preporukama.
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).
Croatian: Međutim, post hoc analize ukazale su da je RotaTeq smanjio broj slučajeva teškog gastroenteritisa uzrokovanog rotavirusom koji je zahtijevao hospitalizaciju ili posjet hitnoj službi i prije primanja sve tri doze cjepiva (tj. nakon približno 14 dana od primanja prve doze cjepiva).
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
Croatian: • Manje često (mogu se javiti u do 1 na 100 dojenčadi): bolovi u trbuhu (također vidjeti gore navedene znakove vrlo rijetke nuspojave intususcepcije), curenje nosa i grlobolja, infekcija uha, osip, krv u stolici
English: Very Rare
Croatian: Rijetko urtikarija
English: In general, the adverse event profile reported with overdose was comparable to that observed with recommended doses of RotaTeq.
Croatian: Profil štetnih događaja prijavljenih kod predoziranja općenito je bio usporediv s onim primijećenim kod primjene preporučenih doza cjepiva RotaTeq.
English: The extent of protection that RotaTeq might provide against other rotavirus types and in other populations is unknown.
Croatian: Nije poznat opseg zaštite koju RotaTeq može pružiti protiv drugih tipova rotavirusa i u drugih populacijskih skupina.
English: What RotaTeq is and what it is used for
Croatian: Što je RotaTeq i za što se koristi
English: - your child developed an allergic reaction after receiving a dose of RotaTeq or other rotavirus vaccine.
Croatian: - ako je Vaše dijete imalo alergijsku reakciju nakon što je primilo dozu RotaTeq cjepiva ili drugog cjepiva protiv rotavirusa.
English: Keep this vaccine out of the sight and reach of children.
Croatian: Cjepivo čuvajte izvan pogleda i dohvata djece.
English: The following other side effects reported with the use of RotaTeq were:
Croatian: Ostale nuspojave prijavljene uz primjenu cjepiva RotaTeq bile su:
English: 8 infectious units per kg (about 14-fold the projected infant dose).
Croatian: 8 infektivnih jedinica po kg (što je oko 14
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).
Croatian: Zdravstveni radnici moraju, opreza radi, pratiti razvoj svih simptoma koji bi mogli ukazivati na intususcepciju (jaka bol u abdomenu, uporno povraćanje, krvave stolice, nadutost abdomena i/ili visoka vrućica), budući da podaci iz opservacijskih ispitivanja ukazuju na povećan rizik od intususcepcije, većinom unutar 7 dana od cijepljenja protiv rotavirusa (vidjeti dio 4.8).
English: Instructions
Croatian: Upute
English: RotaTeq is indicated for the active immunisation of infants from the age of 6 weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1).
Croatian: RotaTeq je indiciran za aktivnu imunizaciju dojenčadi u dobi od 6 tjedana do 32 tjedna radi prevencije gastroenteritisa uzrokovanog infekcijom rotavirusom (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Your child will receive 3 doses of RotaTeq given at least four weeks apart.
Croatian: Vaše će dijete primiti 3 doze RotaTeq cjepiva primijenjene s najmanje četiri tjedna razmaka između doza.
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.
Croatian: Primijeti li se ili posumnja da dijete gotovo sigurno nije progutalo cijelu dozu (npr. da je dojenče ispljunulo ili povratilo cjepivo), zamjenska se doza može dati za vrijeme istog posjeta liječniku premda takvo dodatno doziranje nije ispitivano u kliničkim ispitivanjima.
English: These infants should receive the first dose of vaccine between 6 and 12 weeks after birth.
Croatian: Takva dojenčad treba primiti prvu dozu cjepiva u dobi između 6. do 12. tjedna nakon rođenja.
English: - your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).
Croatian: - ako je Vaše dijete ranije imalo intususcepciju (zastoj u crijevu koji nastane kad se jedan dio crijeva uvuče u drugi dio).
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.
Croatian: Međutim, od 1000 dojenčadi, 19 ih je bilo rođeno u 25. do 28. tjednu gestacije, 55 u 29. do 31. tjednu gestacije, a preostali u 32. do 36. tjednu gestacije.
English: Country:
Croatian: Zemlja:
English: * human-bovine rotavirus reassortants (live), produced in Vero cells.
Croatian: * reasortanti humano-bovinih rotavirusa (živi), proizvedeni na Vero stanicama.
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.
Croatian: RotaTeq se u ispitivanjima izlučio u stolici u 8,9% primatelja cjepiva, gotovo isključivo u prvom tjednu od primitka prve doze te samo u jednog primatelja (0,3%) nakon treće doze cjepiva.
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).
Croatian: U velikom prospektivnom, opservacijskom ispitivanju u Sjedinjenim Američkim Državama nakon stavljanja cjepiva u promet analizirao se rizik od Kawasakijeve bolesti u 85 150 dojenčadi koja je primila jednu ili više doza cjepiva RotaTeq (17 433 osoba-godina praćenja).
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.
Croatian: Nema raspoloživih podataka iz kliničkih ispitivanja o sigurnosti i djelotvornosti primjene RotaTeq cjepiva u imunokompromitirane dojenčadi, dojenčadi zaražene HIV-om ili dojenčadi koja je primila krv ili imunoglobuline transfuzijom unutar 42 dana prije primjene cjepiva
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.
Croatian: Stoga se RotaTeq može davati istodobno s monovalentnim ili kombiniranim cjepivima za dojenčad koja sadrže jedan ili više sljedećih antigena: DTaP, Hib, IPV ili OPV, HBV, PCV i MenCC.
English: D. CONDITION OR RESTRICTION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Tear open the protective bag and remove the dosing tube.
Croatian: Otvorite zaštitnu vrećicu i izvadite tubu za doziranje.
English: The immune response to RotaTeq was unaffected when OPV was administered two weeks after RotaTeq.
Croatian: Imunološki odgovor na RotaTeq nije bio narušen kad se OPV davao dva tjedna nakon primjene RotaTeq cjepiva.
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]).
Croatian: Cjepivo potiče imunološki odgovor (tj. nastanak neutralizirajućih protutijela u serumu) na pet proteina humanog rotavirusa izraženih u reasortantima (G1, G2, G3, G4 i P[8]).
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).
Croatian: Prva se doza RotaTeq cjepiva (2 ml) može dati djetetu starom najmanje 6 tjedana, a svakako se mora dati prije navršenog 12. tjedna (oko 3 mjeseca).
English: • Very common (may affect more than 1 in 10 infants): fever, diarrhoea, vomiting
Croatian: • Vrlo često (mogu se javiti u više od 1 na 10 dojenčadi): vrućica, proljev, povraćanje