FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Ako Vam je liječnik rekao da Vaše dijete ima bolest tzv. nepodnošenja nekih šećera, posavjetujte se sa svojim liječnikom/zdravstvenim radnikom prije nego što Vaše dijete primi ovo cjepivo.
English: United States of America
Croatian: Sjedinjene Američke Države
English: Concomitant administration of RotaTeq and oral poliomyelitis vaccine (OPV) did not affect the immune response to the poliovirus antigens.
Croatian: Istodobna primjena RotaTeq cjepiva i oralnog cjepiva protiv poliomijelitisa (engl. oral poliomyelitis vaccine, OPV) nije utjecala na imunološki odgovor na antigene poliovirusa.
English: What RotaTeq contains
Croatian: Što RotaTeq sadrži
English: The other ingredients in RotaTeq are: sucrose, sodium citrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, polysorbate 80, culture media (containing inorganic salts, amino acids and vitamins), and purified water.
Croatian: Drugi sastojci cjepiva RotaTeq su: saharoza, natrijev citrat, natrijev dihidrogenfosfat hidrat, natrijev hidroksid, polisorbat 80, podloga za kultiviranje (sadrži anorganske soli, aminokiseline i vitamine) i pročišćena voda.
English: The first dose may be administered from the age of 6 weeks and no later than the age of 12 weeks.
Croatian: Prva se doza može primijeniti u dobi od 6 tjedana, ali ne kasnije od 12 tjedana starosti djeteta.
English: rotavirus type* P1A[8]
Croatian: rotavirus serotipa* P1A[8]
English: tube label
Croatian: Naljepnica na tubi
English: Reduction in hospitalisations and emergency department visits for RV gastroenteritis for up to 2 years post-vaccination (RotaTeq n=34,035) (% [95 % CI])
Croatian: Smanjenje broja hospitalizacija i posjeta hitnoj službi zbog gastroenteritisa uzrokovanog rotavirusom do 2 godine nakon cijepljenja (RotaTeq n=34 035) (% [95% CI])
English: Infectious Units
Croatian: infektivnih jedinica
English: Under no circumstance should this vaccine be administered by injection.
Croatian: Ovo se cjepivo ni u kojem slučaju ne smije primjenjivati injekcijom.
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.
Croatian: U prerano rođene djece (u 28. tjednu trudnoće ili ranije) mogu se javiti duži razmaci između udisaja tijekom 2 do 3 dana nakon primjene cjepiva.
English: During year 3, there were no health care contacts for RV gastroenteritis in the vaccine group (n=3,112) and one (non-typeable) in the placebo group (n=3,126).
Croatian: Tijekom treće godine nije bilo slučajeva traženja liječničke pomoći zbog gastroenteritisa uzrokovanog rotavirusom u skupini cijepljenoj cjepivom (n=3112) dok je jedan takav slučaj bio u placebo skupini (n=3126).
English: The overall frequency of these serious adverse reactions was 0.1 % among recipients of RotaTeq and 0.2 % among placebo recipients.
Croatian: Ukupna učestalost ozbiljnih nuspojava bila je 0,1% među primateljima cjepiva RotaTeq te 0,2% među primateljima placeba.
English: 2 ml solution in a pre-filled squeezable tube (LDPE), with a twist-off cap (HDPE) in a protective bag, pack size of 1 or 10 pre-filled squeezable tube(s).
Croatian: 2 ml otopine u napunjenoj tubi (LDPE) za istiskivanje, sa zatvaračem na navoj (HDPE), u zaštitnoj vrećici, pakiranje od 1 ili 10 tuba za istiskivanje.
English: Adverse Reaction/Event
Croatian: Nuspojava/štetni događaj
English: Anaphylactic reaction
Croatian: Nepoznato anafilaktična reakcija
English: Oral Solution Pale yellow clear liquid that may have a pink tint
Croatian: Oralna otopina Blijedožuta bistra tekućina s mogućom ružičastom nijansom
English: • Common (may affect up to 1 in 10 infants): infections of the upper respiratory system
Croatian: • Često (mogu se javiti u do 1 na 10 dojenčadi): infekcije gornjih dišnih puteva
English: RotaTeq may be given without regard to food, liquid, or breast milk.
Croatian: RotaTeq se može dati bez obzira na hranu, piće ili majčino mlijeko.
English: These antibodies help protect against gastroenteritis caused by these types of rotavirus.
Croatian: Ova protutijela štite od gastroenteritisa uzrokovanog ovim tipovima rotavirusa.
English: Hospitalization and ED visits due to all cause gastroenteritis
Croatian: Hospitalizacija i dolazak na odjel hitne medicine zbog gastroenteritisa svih uzroka
English: The vaccine can be given without regard to food, liquid, or breast milk.
Croatian: Cjepivo se može dati bez obzira na hranu, piće ili majčino mlijeko.
English: Address:
Croatian: Adresa:
English: The immunological mechanism by which RotaTeq protects against rotavirus gastroenteritis is not completely understood.
Croatian: Imunološki mehanizam kojim RotaTeq štiti od gastroenteritisa uzrokovanog rotavirusom nije potpuno poznat.
English: The safety and efficacy of RotaTeq were comparable between this subset of infants and infants born at term.
Croatian: Sigurnost i djelotvornost RotaTeq cjepiva bila je usporediva između te skupine dojenčadi i dojenčadi rođene u terminu.
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.
Croatian: Preporučuje se da djeca prime sve tri doze do dobi od 20. do 22. tjedna, a najkasnije do dobi od 32 tjedna.
English: The vaccine will be given by gently squeezing the tube and delivering the vaccine into your child's mouth.
Croatian: Cjepivo će se dati laganim pritiskanjem tube i istiskivanjem cjepiva u djetetova usta.
English: The vaccine is to be administered orally without mixing with any other vaccines or solutions.
Croatian: Cjepivo treba primijeniti kroz usta, ne miješajući ga s drugim cjepivima ili otopinama.
English: Based upon combined data from REST and the FES, the reduction up to 3 years post-vaccination in the rate of hospitalisations and emergency department visits for RV gastroenteritis was 94.4 % (95 % CI: 91.6, 96.2) for genotypes G1-G4, 95.5 % (95 % CI: 92.8, 97.2) for genotype G1, 81.9 % (95 % CI: 16.1, 98.0) for genotype G2, 89.0 % (95 % CI: 53.3, 98.7) for genotype G3, 83.4 % (95 % CI: 51.2, 95.8) for genotype G4, and 94.2 % (95 % CI: 62.2, 99.9) for genotype G9.
Croatian: Smanjena učestalost hospitalizacije i posjeta hitnim službama zbog gastroenteritisa uzokovanog rotavirusom serotipova G1-G4 od 94,4% (95% CI: 91,6; 96,2) tijekom 3 godine nakon cijepljenja temeljena je na kombiniranim podacima iz REST i FES ispitivanja; za genotip G1 bila je 95,5% (95% CI: 92,8; 97,2); za genotip G2 81,9% (95% CI: 16,1; 98,0), za genotip G3 89,0% (95% CI: 53,3; 98,7), za genotip G4 83,4% (95% CI 51,2; 95,8) i za genotip G9 94,2% (95% CI: 62,2; 99,9).
English: As no data exist regarding the interchangeability of RotaTeq with another rotavirus vaccine, it is recommended that infants who receive RotaTeq for the first immunisation against rotavirus should receive this same vaccine for the subsequent doses.
Croatian: Budući da nema saznanja o zamjenjivosti RotaTeq cjepiva s drugim cjepivima protiv rotavirusa, preporučuje se da dojenčad koja primi RotaTeq u prvoj imunizaciji protiv rotavirusa nastavi primati isto cjepivo i u docjepljivanju ostalim dvjema dozama.
English: Package Leaflet: Information for the user RotaTeq oral solution Rotavirus vaccine, live
Croatian: Uputa o lijeku: Informacije za korisnika RotaTeq oralna otopina cjepivo protiv rotavirusa, živo
English: When RotaTeq is given to your child for the first dose, it is recommended that your child also receives RotaTeq (and not another rotavirus vaccine) to complete the vaccination course.
Croatian: Primi li Vaše dijete prvu dozu RotaTeq cjepiva, preporučuje se da do kraja cijepljenja također prima RotaTeq (a ne neko drugo cjepivo protiv rotavirusa).
English: Subjects with congenital malformation of the gastrointestinal tract that could predispose to intussusception.
Croatian: Djeca s kongenitalnom malformacijom gastrointestinalnog trakta koja bi mogla biti sklona razvoju intususcepcije.
English: Hypersensitivity after previous administration of rotavirus vaccines.
Croatian: Preosjetljivost nakon prethodne primjene cjepiva protiv rotavirusa.
English: 2 ml oral solution in a tube pack size of 1 tube pack size of 10 tubes
Croatian: 2 ml oralne otopine u tubi Pakiranje od 1 tube
English: See also section 3.
Croatian: Pogledajte također dio 3.
English: RotaTeq does not protect against gastroenteritis due to other pathogens than rotavirus.
Croatian: RotaTeq ne štiti od gastroenteritisa uzrokovanog drugim patogenima osim rotavirusa.
English: Do not use RotaTeq if:
Croatian: Nemojte primjenjivati RotaTeq:
English: Other medicines and RotaTeq:
Croatian: Drugi lijekovi i RotaTeq
English: A complete 3-dose vaccination series of RotaTeq should be administered (see section 4.2) to provide the level and duration of protection against rotavirus gastroenteritis that was observed in the clinical studies.
Croatian: Potrebno je primiti sve 3 doze cjepiva RotaTeq (vidjeti dio 4.2) kako bi razina i trajanje zaštite od gastroenteritisa uzrokovanog rotavirusom bila jednaka onoj zamijećenoj u kliničkim ispitivanjima.
English: However, in the absence of sufficient data, administration of RotaTeq to asymptomatic HIV-infected infants is not recommended.
Croatian: Međutim, kako nema dovoljno podataka, ne preporučuje se primjena cjepiva RotaTeq u dojenčadi s asimptomatskom infekcijom HIV-om.
English: One chart-confirmed case was recorded among infants vaccinated with RotaTeq compared with one chart-confirmed case among concurrent DTaP controls (relative risk = 0.7, 95 % CI: 0.01-55.56).
Croatian: Zabilježen je jedan slučaj na temelju medicinske dokumentacije u dojenčadi cijepljene cjepivom RotaTeq i jedan takav slučaj na temelju medicinske dokumentacije u kontrolnoj skupini dojenčadi cijepljene cjepivom DTaP u istom razdoblju (relativni rizik = 0,7, 95% CI: 0,01; 55,56).
English: RotaTeq is an oral vaccine that helps protect infants and young children against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection and may be given to infants from the age of 6 weeks to 32 weeks (see section 3).
Croatian: RotaTeq je cjepivo koje se uzima kroz usta i koje pomaže u zaštiti dojenčadi i male djece od gastroenteritisa (proljeva i povraćanja) uzrokovanog infekcijom rotavirusom te se može primijeniti u dojenčadi u dobi od 6 tjedana do 32 tjedna (pogledajte dio 3).
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.
Croatian: Zaboravite li ili iz drugog razloga propustite obaviti sljedeći posjet u dogovoreno vrijeme, posavjetujte se sa svojim liječnikom/zdravstvenim radnikom.
English: Co-administration of RotaTeq with a group C meningococcal conjugate vaccine (MenCC, the vaccine studied was a tetanus toxoid conjugate) at 3 and 5 months of age (and mostly at the same time as DTaP-IPV-Hib vaccine), followed by a third dose of RotaTeq at approximately 6 months of age, demonstrated that the immune responses to RotaTeq and MenCC were unaffected.
Croatian: Pokazalo se da istodobna primjena cjepiva RotaTeq s konjugiranim cjepivom protiv meningokoka grupe C (MenCC, ispitivano cjepivo bilo je konjugat toksoida tetanusa) u dojenčadi u dobi od 3 i 5 mjeseci (i većinom u isto vrijeme s cjepivima DTaP-IPV-Hib), nakon čega se treća doza cjepiva RotaTeq primijenila u dobi od približno 6 mjeseci, ne utječe na imunološki odgovor na RotaTeq i MenCC.
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.
Croatian: U 68 038 cijepljene dojenčadi (34 035 u skupini koja je primila cjepivo) zaštitna djelotvornost cjepiva mjerena je smanjenjem stope hospitalizacija i posjeta hitnoj službi zbog gastroenteritisa uzrokovanog rotavirusom u vremenu od 14 dana nakon primitka treće doze cjepiva.
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.
Croatian: U 5673 cijepljene dojenčadi (2834 u skupini koja je primila cjepivo) zaštitna djelotvornost cjepiva mjerena je smanjenjem incidencije gastroenteritisa uzrokovanog G genotipovima (G1-G4) rotavirusa obuhvaćenih cjepivom u vremenu od najmanje 14 dana nakon primitka treće doze cjepiva pa sve do kraja cijele prve sezone pojave rotavirusa nakon cijepljenja.
English: No immunological correlate of protection has currently been identified for rotavirus vaccines.
Croatian: Zasada nije pronađen imunološki korelat zaštite za cjepiva protiv rotavirusa.
English: It is preferable that the vaccination course of three doses should be completed by the age of 20-22 weeks.
Croatian: Preporučuje se da se ciklus cijepljenja od tri doze dovrši do dobi od 20. do 22. tjedna starosti djeteta.
English: RotaTeq may be given to infants who were born prematurely provided that the period of gestation was at least 25 weeks.
Croatian: RotaTeq se može davati prerano rođenoj dojenčadi pod uvjetom da je razdoblje gestacije trajalo najmanje 25 tjedana.
English: Read all of this leaflet carefully before your child is vaccinated because it contains important information for you.
Croatian: Vaše dijete primi cjepivo jer sadrži Vama važne podatke.
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.
Croatian: U REST ispitivanju, u populaciji određenoj protokolom ispitivanja, bile su pružene 403 zdravstvene usluge (20 u skupini cijepljenoj cjepivom i 383 u placebo skupini) povezane s gastroenteritisom uzrokovanim G1-G4 i G9 rotavirusom.
English: The protective efficacy of RotaTeq was evaluated in two ways in the placebo-controlled Rotavirus Efficacy and Safety Trial (REST):
Croatian: Zaštitna djelotvornost RotaTeq cjepiva procijenjena je na dva načina u placebom kontroliranom ispitivanju pod nazivom Ispitivanje djelotvornosti i sigurnosti cjepiva protiv rotavirusa (engl.
English: Adverse reactions more common in the vaccine group in clinical trials are listed below per system organ class and frequency.
Croatian: Nuspojave koje su se češće javljale u skupini koja je u kliničkim ispitivanjima primala cjepivo navedene su niže i raspoređene su po organskim sustavima i učestalosti.
English: Do not use this vaccine after the expiry date which is stated on the label after EXP.
Croatian: Ovo cjepivo se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju, vrećici i naljepnici iza oznake "EXP".
English: See section 6.6 for administration instructions.
Croatian: Za uputu o primjeni vidjeti dio 6.6.
English: The reduction in incidence of RV gastroenteritis caused by genotypes G1-G4 during the second rotavirus season after vaccination was 88.0 % [95 % CI 49.4, 98.7] for severe disease and 62.6 % [95 % CI 44.3, 75.4] for disease of any severity.
Croatian: Smanjenje incidencije gastroenteritisa uzrokovanog genotipovima G1-G4 rotavirusa obuhvaćenih cjepivom tijekom druge sezone nakon cijepljenja bila je 88,0% [95% CI 49,4; 98,7] za teške oblike bolesti, a 62,6% [95% CI 44,3; 75,4] za sve težine bolesti.
English: RotaTeq is intended for use in infants only.
Croatian: RotaTeq je namijenjen isključivo dojenčadi.
English: • Rare (may affect up to 1 in 1000 infants): hives
Croatian: • Rijetko (mogu se javiti u do 1 na 1000 dojenčadi): koprivnjača
English: Co-administration of RotaTeq with vaccines containing one or more of the following antigens at approximately 2, 4 and 6 months of age demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected: - Diphtheria-tetanus-acellular pertussis vaccine (DTaP) - Haemophilus influenzae type b vaccine (Hib) - Inactivated poliomyelitis vaccine (IPV) - Hepatitis B vaccine (HBV) - Pneumococcal conjugate vaccine (PCV)
Croatian: Pokazalo se da istodobna primjena cjepiva RotaTeq s cjepivima koja sadrže jedan ili više sljedećih antigena u dojenčadi u dobi od približno 2, 4 i 6 mjeseci ne utječe na imunološki odgovor i profile sigurnosti primijenjenih cjepiva: - cjepivo protiv difterije, tetanusa i pertusisa (acelularno) (DTaP) - cjepivo protiv bakterije Haemophilus influenzae tipa B (Hib) - inaktivirano cjepivo protiv dječje paralize (IPV) - cjepivo protiv hepatitisa B (HBV) - konjugirano cjepivo protiv pneumokoka (PCV)
English: In phase III studies between 92.5 % and 100 % of recipients of RotaTeq achieved a significant rise in serum anti-rotavirus IgA after a three-dose regimen.
Croatian: U fazi III kliničkih ispitivanja, 92,5-100% primatelja cjepiva RotaTeq imalo je značajan rast IgA nakon primitka režima od tri doze.
English: Overall, 47 % of infants given RotaTeq experienced an adverse reaction compared with 45.8 % of infants given placebo.
Croatian: Nuspojave su zamijećene u ukupno 47% dojenčadi koja su primala RotaTeq, odnosno 45,8% dojenčadi koja su primala placebo.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva Manje često osip
English: Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty.
Croatian: Primijenite dozu polagano istiskujući tekućinu u djetetova usta prema unutrašnjoj strani obraza, dok potpuno ne ispraznite tubu za doziranje.
English: *RV-negative acute gastroenteritis controls
Croatian: *Kontrole s akutnim gastroenteritisom negativne na rotavirus
English: RotaTeq oral solution Rotavirus vaccine, live
Croatian: RotaTeq oralna otopina cjepivo protiv rotavirusa, živo
English: e-mail@msd.de
Croatian: info@msd.fi
English: Keep the dosing tube in the outer carton in order to protect from light.
Croatian: Tubu za doziranje čuvati u vanjskom kartonskom pakiranju radi zaštite od svjetlosti.
English: Administration of RotaTeq should be postponed in infants suffering from acute severe febrile illness.
Croatian: Primjena RotaTeq cjepiva se mora odgoditi u dojenčadi koja imaju tešku akutnu bolest s vrućicom.
English: Telephone:
Croatian: Tel:
English: From 6 weeks to 32 weeks
Croatian: Od rođenja do 6 tjedana
English: Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650 info@msd.fi
Croatian: Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650
English: Puncture the dispensing tip by screwing cap clockwise until it becomes tight.
Croatian: Probijte vršak tako da zavrnete zatvarač u smjeru kazaljke na satu dok ne postane čvrsto.
English: Based on pooled data from 3 clinical trials in which 6,130 infants received RotaTeq and 5,560 received placebo, the adverse reactions listed occurred with excess incidences in RotaTeq recipients compared to placebo recipients of between 0.2 % and 2.5 %.
Croatian: Na temelju objedinjenih podataka dobivenih iz 3 klinička ispitivanja u kojima je 6130 dojenčadi primalo RotaTeq, a 5560 placebo, navedene nuspojave bile su od 0,2% do 2,5% češće zabilježene u primatelja cjepiva RotaTeq nego u primatelja placeba.
English: In a combined post-hoc analysis of REST and another phase III study, the vaccine efficacy against G1, G2-, G3- and G4-serotype RVG cases (any severity) was 61.5 % [95 % CI: 14.2; 84.2] among infants who were >26 to ≤32 weeks of age at dose 3.
Croatian: U analizi skupnih podataka iz REST kliničkog ispitivanja i još jednog ispitivanja faze III, djelotvornost cjepiva protiv gastroenteritisa (bilo koje jačine) uzrokovanog rotavirusom serotipova G1, G2, G3 i G4 bila je 61,5% [95% CI: 14,2; 84,2] u dojenčadi u dobi od 26 tjedana, a 32 tjedna prilikom primjene treće doze cjepiva.
English: Reduction in incidence of RV gastroenteritis through one full season post-vaccination (RotaTeq n=2,834) (% [95 % CI]) Efficacy against any severity by rotavirus genotype
Croatian: Smanjenje incidencije gastroenteritisa uzrokovanog rotavirusom do kraja cijele prve sezone nakon cijepljenja (RotaTeq n=2834) (% [95% CI]) Djelotvornost protiv svih oblika rotavirus genotipa
English: MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561
Croatian: MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de
English: In clinical trials, efficacy was demonstrated against gastroenteritis due to rotavirus of genotypes G1P[8], G2P[4], G3P[8], G4P[8], and G9P[8].
Croatian: U kliničkim se ispitivanjima pokazala djelotvornost protiv gastroenteritisa prouzročenog genotipovima rotavirusa G1P[8], G2P[4], G3P[8], G4P[8] i G9P[8].
English: Waarderweg 39, 2031 BN Haarlem, P.O.
Croatian: Waarderweg 39, 2031 BN Haarlem - P.O. BOX 581, 2003 PC Haarlem
English: Effectiveness study data Post marketing studies demonstrating effectiveness to prevent RV gastroenteritis (RVGE)
Croatian: Ispitivanja nakon stavljanja cjepiva u promet koja pokazuju učinkovitost u sprječavanju gastroenteritisa prouzročenog rotavirusom (engl. rotavirus gastroenteritis, RVGE)
English: Bronchospasm
Croatian: Rijetko bronhospazam
English: In a clinical study, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks.
Croatian: U kliničkom ispitivanju RotaTeq je primilo približno 1000 dojenčadi rođenih između 25. i 36. tjedna gestacije.
English: RotaTeq may be given at the same time as your child receives other normally recommended vaccinations, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, inactivated or oral poliomyelitis, hepatitis B, pneumococcal conjugate and meningococcus group C conjugate vaccines.
Croatian: Vaše dijete može primati RotaTeq istodobno s drugim uobičajeno preporučenim cjepivima za djecu poput onih protiv difterije, tetanusa, pertusisa (hripavca), bakterije Haemophilus influenzae tipa B, umrtvljenim cjepivom protiv dječje paralize ili cjepivom protiv dječje paralize koje se uzima kroz usta, cjepivom protiv hepatitisa B, konjugiranim cjepivom protiv pneumokoka i konjugiranim cjepivom protiv meningokoka grupe C.
English: Severe* disease (G1-G4)
Croatian: Teški oblik* bolesti (G1-G4)
English: A doctor or nurse will administer the recommended doses of RotaTeq to your child.
Croatian: Djetetu će preporučene doze RotaTeq cjepiva dati liječnik ili medicinska sestra.
English: No clinical data are available on the use of RotaTeq for post-exposure prophylaxis.
Croatian: Nema kliničkih podataka o primjeni RotaTeq cjepiva u profilaksi nakon izloženosti virusu.
English: This adverse reaction was identified through post-marketing surveillance.
Croatian: Ova nuspojava utvrđena je u razdoblju praćenja nakon stavljanja u promet.
English: MSD VACCINS, 162 avenue Jean Jaurès, 69007 LYON, France.
Croatian: MSD VACCINS, 162 avenue Jean Jaurès, 69007 LYON, Francuska.
English: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Croatian: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Francuska
English: See section 2.
Croatian: Vidjeti dio 2.
English: Upper respiratory tract infection
Croatian: Često infekcija gornjih dišnih puteva
English: If you forget an appointment for RotaTeq:
Croatian: Ako ste zaboravili na dogovoreno cijepljenje RotaTeq cjepivom:
English: FOR ORAL USE ONLY Read the package leaflet before use
Croatian: SAMO ZA PRIMJENU KROZ USTA Prije uporabe pročitajte uputu o lijeku.
English: Age-specific - 1st year of life - 2nd year of life - 3rd year of life - 4th year of life - 5th year of life - 6th-7th year of life
Croatian: Specifičan za soj - G1P[8] - G2P[4] - G3P[8] - G12P[8] Specifičan za dob - 1. godina života - 2. godina života - 3. godina života - 4. godina života - 5. godina života - 6.-7. godina života
English: 6 Infectious Units P1A[8] 2.3 x 10
Croatian: P1A[8] 2,3 x 10
English: The infants were followed for up to 3 years post-vaccination in the FES.
Croatian: Cijepljena dojenčad bila je praćena tijekom 3 godine nakon cijepljena u FES ispitivanju.