FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Ispitivanja utjecaja cjepiva Rotarix provedena u Panami, Brazilu i Meksiku pokazala su smanjenje mortaliteta zbog proljeva bilo kojeg uzroka u rasponu od 17% do 73% u djece mlađe od 5 godina, unutar 2 do 4 godine nakon uvođenja cjepiva.
English: There are no data on the use of Rotarix during pregnancy and lactation.
Croatian: Nema podataka o primjeni cjepiva Rotarix tijekom trudnoće i dojenja.
English: A clinical study in a limited number of asymptomatic or mildly symptomatic HIV positive infants showed no apparent safety problems (see section 4.8).
Croatian: Klinička studija na ograničenom broju HIV pozitivne dojenčadi bez simptoma ili s blažim simptomima pokazala je da ne postoje očiti problemi sa sigurnošću primjene
English: Transfer the entire content of the oral applicator into the glass container containing the powder
Croatian: Istisnite cijeli sadržaj oralnog aplikatora u stakleni spremnik s praškom
English: A. What you need to do before giving Rotarix
Croatian: A. Što trebate učiniti prije davanja cjepiva Rotarix
English: D. Store remaining doses in the fridge immediately
Croatian: Preostale doze odmah spremite u hladnjak
English: During the first year, significantly fewer subjects in the Rotarix group reported severe rotavirus gastroenteritis caused by the circulating wild-type RV compared to the placebo group from 2 weeks after Dose 2 up to one year of age (0.0% versus 0.3%), with a vaccine efficacy of 100% (95% CI: 72.2;
Croatian: Tijekom prve godine, značajno manje osoba u Rotarix skupini je prijavilo teški rotavirusni gastroenteritis uzrokovan cirkulirajućim divljim sojem RV u odnosu na placebo skupinu, od 2. tjedna nakon druge doze sve do kraja 1. godine života (0,0% nasuprot 0,3%), s djelotvornosti cjepiva od 100% (95% CI: 72,2; 100).
English: Rotarix is supplied as a whitish powder in a single dose glass container and a separate oral applicator of solvent which contains a slow settling white deposit and a colourless supernatant.
Croatian: Rotarix dolazi u obliku bjelkastog praška u jednodoznom staklenom spremniku i otapala u zasebnom oralnom aplikatoru koji sadrži bijeli talog koji se polako taloži i bezbojni supernatant.
English: Press the cap down to pierce the membrane.
Croatian: Pritisnite zatvarač prema dolje kako biste probušili membranu.
English: Oral applicator
Croatian: Oralni aplikator
English: In addition, nine impact studies on all-cause diarrhoea hospitalisation conducted in Africa and Latin America showed a reduction of 14% to 57% between 2 and 5 years after vaccine introduction.
Croatian: Uz to, devet ispitivanja utjecaja na hospitalizaciju zbog proljeva bilo kojeg uzroka provedena u Africi i Južnoj Americi pokazala su smanjenje od 14% do 57% između 2 i 5 godina nakon uvođenja cjepiva.
English: 1 dose of powder in a glass container (type I glass) with a stopper (rubber butyl) 1 ml of solvent in an oral applicator (type I glass) with a plunger stopper and a protective tip cap (rubber butyl).
Croatian: 1 doza praška u staklenom spremniku (staklo tipa I) sa čepom (butil guma) 1 ml otapala u oralnom aplikatoru (staklo tipa I) sa čepom klipa i zaštitnim zatvaračem vrha (butil guma).
English: A clinical study performed in Africa (Rotarix: N = 2,974; placebo: N = 1,443) evaluated Rotarix given at approximately 10 and 14 weeks of age (2 doses) or 6, 10 and 14 weeks of age (3 doses).
Croatian: Klinička studija provedena u Africi (Rotarix: N = 2974; placebo: N = 1443) procjenjivala je Rotarix primijenjen u dobi od približno 10 i 14 tjedana (2 doze) ili 6, 10 i 14 tjedana (3 doze).
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: Ako Vaše dijete ispljune ili povrati većinu doze cjepiva, u istom posjetu liječniku može dobiti jednu zamjensku dozu.
English: Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was shown to be maintained in a clinical trial involving more than 4,200 subjects who received Rotarix concomitantly with OPV.
Croatian: Iako istodobna primjena OPV cjepiva može neznatno smanjiti imunološki odgovor na cjepivo protiv rotavirusa, klinička zaštita protiv teškog gastroenteritisa izazvanog rotavirusom je dokazano održana u kliničkom ispitivanju koje je uključivalo više od 4200
English: 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:
Croatian: Zaštitna djelotvornost cjepiva protiv teškog rotavirusnog (RV) gastroenteritisa koji je zahtijevao hospitalizaciju i/ili rehidracijsku terapiju u medicinskoj ustanovi i genotip specifična djelotvornost cjepiva nakon dvije doze cjepiva Rotarix prikazani su u sljedećoj tablici:
English: Both components must be mixed together before your child receives the vaccine.
Croatian: Prije nego što Vaše dijete primi cjepivo, oba sastojka se moraju pomiješati.
English: B Get the tube ready
Croatian: B Priprema tube
English: GlaxoSmithKline Biologicals s.a. Parc de la Noire Epine Rue Fleming, 20
Croatian: Parc de la Noire Epine Rue Fleming, 20
English: Those trials have shown that the safety profile of the liquid formulation is comparable to the lyophilised formulation.
Croatian: Ta su ispitivanja pokazala da je sigurnosni profil tekuće formulacije usporediv s liofiliziranim formulacijom.
English: The vaccine efficacy against severe rotavirus gastro-enteritis during the first year of life was 61.2% (95% CI: 44.0;73.2).
Croatian: Djelotvornost cjepiva protiv teških rotavirusnih gastroenteritisa tijekom prve godine života iznosila je 61,2% (95% CI: 44,0;73,2).
English: The first dose may be given from the age of 6 weeks.
Croatian: Prvu dozu dijete može primiti u dobi od 6 tjedana.
English: Instructions for reconstitution and administration of the vaccine:
Croatian: Upute za rekonstituciju i primjenu cjepiva:
English: These data should be interpreted with caution Sustained efficacy up to 3 years of age in Asia A clinical study conducted in Asia (Hong Kong, Singapore and Taiwan) (Total vaccinated cohort: Rotarix: N = 5,359; placebo: N = 5,349) evaluated Rotarix given according to different schedules (2, 4 months of age; 3, 4 months of age).
Croatian: Ove podatke treba interpretirati s oprezom Postojana djelotvornost do 3. godine života u Aziji Klinička studija provedena u Aziji (Hong Kong, Singapur i Tajvan), (ukupna procjepljena kohorta: Rotarix: N = 5359; placebo: N = 5349), procjenjivala je Rotarix primijenjen prema različitim rasporedima cijepljenja (2, 4 mjeseca starosti; 3, 4 mjeseca starosti).
English: Viral antigen particles detected by ELISA were found in 50% of stools after the first dose and 4% of stools after the second dose.
Croatian: Djelići virusnog antigena otkriveni ELISA testom nađeni su u 50% uzoraka stolica nakon prve doze i u 4% uzoraka stolica nakon druge doze.
English: Vaccine efficacy was 100% (95% CI: 67.5; 100).
Croatian: Djelotvornost cjepiva je iznosila 100% (95% CI: 67,5; 100).
English: In a clinical study, 670 pre-term infants from 27 to 36 weeks of gestational age were administered Rotarix and 339 received placebo.
Croatian: U kliničkoj studiji, kod 670 prijevremeno rođene dojenčadi u gestacijskoj dobi od 27 do 36 tjedana starosti primijenjen je Rotarix, dok je njih 339 primilo placebo.
English: After two doses of Rotarix, the protective vaccine efficacy observed during the first and second year of life is presented in the following table:
Croatian: Nakon dvije doze cjepiva Rotarix uočena zaštitna djelotvornost tijekom prve i druge godine života prikazana je u sljedećoj tablici:
English: After your child has received Rotarix, contact a doctor/health care professional right away if your child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever (see also section 4 “Possible side effects”).
Croatian: Ako kod djeteta nakon što je primilo Rotarix primijetite jaku bol u trbuhu, neprestano povraćanje, pojavu krvi u stolici, nadutost trbuha i/ili visoku vrućicu, odmah kontaktirajte liječnika ili drugog zdravstvenog djelatnika (pogledajte također dio 4 ''Moguće nuspojave'').
English: Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code: J07BH01 Protective efficacy
Croatian: Farmakoterapijska skupina: cjepivo protiv rotavirusa, ATK oznaka: J07BH01 Zaštitna djelotvornost
English: LIST OF EXCIPIENTS Powder: sucrose, sorbitol See the package leaflet for further information
Croatian: Prašak: saharoza, sorbitol Za daljnje informacije vidjeti uputu o lijeku
English: The efficacy against severe RV gastro-enteritis requiring hospitalisation was 100% (95% CI: 72.4; 100).
Croatian: Djelotvornost cjepiva protiv teškog RV gastroenteritisa koji je zahtijevao hospitalizaciju iznosila je 100% (95% CI: 72,4; 100).
English: Check the expiry date on the connecting bar. 2.
Croatian: Provjerite rok valjanosti na spojnoj traci.
English: After reconstitution, the vaccine contained in the oral applicator should be administered promptly.
Croatian: Nakon rekonstitucije, cjepivo koje se nalazi u oralnom aplikatoru mora se odmah primijeniti.
English: A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastro-enteritis has not been established.
Croatian: Nije ustanovljen odnos između odgovora protutijela na cijepljenje protiv rotavirusa i zaštite protiv rotavirusnog gastroenteritisa.
English: (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).
Croatian: (6) u ispitanika koji nisu dovršili ciklus cijepljenja, učinkovitost nakon jedne doze je bila od 51% (95% CI: 26;67, Salvador) do 60% (95% CI: 37;75, Brazil).
English: e) Hold the tab of the separated oral tube in one hand and the connecting bar in the other hand.
Croatian: e) Jednom rukom držite jezičak odvojene tube za oralnu primjenu, a drugom spojnu traku.
English: In a total of four clinical trials, approximately 3,800 doses of Rotarix liquid formulation were administered to approximately 1,900 infants.
Croatian: U ukupno četiri klinička ispitivanja, primijenjeno je oko 3800 doza tekuće formulacije cjepiva Rotarix u oko 1900 dojenčadi.
English: After the reconstitution, the vaccine should be administered immediately.
Croatian: Nakon rekonstitucije cjepivo treba odmah primijeniti.
English: Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency (SCID) disorder
Croatian: gastroenteritis s izlučivanjem cjepnog virusa stolicom u dojenčadi s teškim poremećajem kombinirane imunodeficijencije
English: Mexico
Croatian: Meksiko
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.5 ml) contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 doza (1,5 ml) sadrži:
English: Dispose of in accordance with local regulations.
Croatian: Zbrinuti sukladno nacionalnim propisima.
English: The immunologic mechanism by which Rotarix protects against rotavirus gastro-enteritis is not completely understood.
Croatian: Imunološki mehanizam kojim Rotarix štiti protiv rotavirusnog gastroenteritisa nije u potpunosti razjašnjen.
English: Rotarix is a clear and colourless liquid.
Croatian: Rotarix je bistra i bezbojna otopina.
English: EU/1/05/330/001 - pack of 1 (glass container + oral applicator + transfer adapter) EU/1/05/330/002 - pack of 5 (glass container + oral applicator + transfer adapter) EU/1/05/330/003 - pack of 10 (glass container + oral applicator + transfer adapter) EU/1/05/330/004 - pack of 25 (glass container + oral applicator + transfer adapter)
Croatian: EU/1/05/330/001 - pakiranje od 1 (stakleni spremnik + oralni aplikator + nastavak za prijenos) EU/1/05/330/002 - pakiranje od 5 (stakleni spremnik + oralni aplikator + nastavak za prijenos) EU/1/05/330/003 - pakiranje od 10 (stakleni spremnik + oralni aplikator + nastavak za prijenos) EU/1/05/330/004 - pakiranje od 25 (stakleni spremnik + oralni aplikator + nastavak za prijenos)
English: ♦ Uncommon (These may occur with up to 1 in 100 doses of the vaccine):
Croatian: ♦ Manje često (mogu se javiti u do 1 na 100 doza cjepiva):
English: 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.
Croatian: Dvije doze cjepiva moraju se dati do navršena 24 tjedna života, iako se preporučuje da se daju prije navršenih 16 tjedana života.
English: Administer the entire content of the oral applicator orally (by administering the entire content of the oral applicator on the inside of the cheek)
Croatian: Peroralno primijenite cjelokupni sadržaj oralnog aplikatora (istiskujući cjelokupni sadržaj oralnog aplikatora uz unutarnju stranu obraza)
English: - The other ingredients in Rotarix are:
Croatian: - Pomoćne tvari u cjepivu Rotarix su:
English: • he/she has any disorder of the gastrointestinal system.
Croatian: • ima bilo koji poremećaj probavnog sustava.
English: Instructions for administration of the vaccine in a squeezable tube: Please read the instructions for use all the way through before starting to give the vaccine.
Croatian: Upute za primjenu cjepiva u tubi za istiskivanje: Prije primjene cjepiva pročitati do kraja upute za primjenu cjepiva.
English: The vaccine contains sucrose and sorbitol as excipients.
Croatian: Cjepivo sadrži saharozu i sorbitol kao pomoćne tvari.
English: No data are available on the use of Rotarix for post-exposure prophylaxis.
Croatian: Nema dostupnih podataka o primjeni cjepiva Rotarix za profilaksu nakon izlaganja virusu.
English: Scientific conclusions
Croatian: PRILOG IV. ZNANSTVENI ZAKLJUČCI
English: 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.
Croatian: U retrospektivnom ispitivanju baze podataka provedenom u Belgiji, u djece u dobi od 5 godina i mlađe, direktni i indirektni utjecaj cijepljenja cjepivom Rotarix na hospitalizaciju povezanu s rotavirusom bio je u rasponu od 64% (95% CI: 49;76) do 80% (95% CI: 77;83) dvije godine nakon uvođenja cjepiva.
English: Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code: J07BH01 Protective efficacy of the lyophilised formulation
Croatian: Farmakoterapijska skupina: cjepivo protiv rotavirusa, ATK oznaka: J07BH01 Zaštitna djelotvornost liofiliziranog oblika
English: 51% (95% CI: 26;67, El Salvador) to 60% (95% CI: 37; 75, Brazil).
Croatian: 26;67, Salvador) do 60% (95% CI: 37;75, Brazil).
English: In a clinical study, 100 infants with HIV infection were administered Rotarix lyophilised formulation or placebo.
Croatian: U kliničkoj studiji, kod 100 dojenčadi s HIV infekcijom primilo je liofilizirani oblik cjepiva Rotarix ili placebo.
English: Low Income Countries
Croatian: Države s malim prihodima
English: The vaccine (1 ml liquid) will be given orally.
Croatian: Cjepivo (1 ml tekućine) će se dati kroz usta.
English: A pooled analysis of five efficacy studies*, showed a 71.4% (95% CI:20.1;91.1) efficacy against severe rotavirus gastro-enteritis (Vesikari score ≥11) caused by rotavirus G2P[4] genotype during the first year of life.
Croatian: Skupna analiza pet ispitivanja djelotvornosti*, pokazala je djelotvornost od 71,4% (95% CI: 20,1;91,1) protiv teškog rotavirusnog gastroenteritisa (Vesikari rezultat ≥11) uzrokovanog rotavirusom genotipa G2P[4] tijekom prve godine života.
English: • if your child has a rare inherited illness which affects their immune system called Severe Combined Immunodeficiency (SCID).
Croatian: • ako Vaše dijete boluje od rijetke nasljedne bolesti koja pogađa njegov imunološki sustav, a zove se teška kombinirana imunodeficijencija.
English: Efficacy up to 2 years of age Rotarix N= 5,263 Placebo N= 5,256 Vaccine efficacy (%) against severe rotavirus gastro-enteritis [95% CI] Genotype
Croatian: Djelotvornost do 2. godine života Rotarix N= 5263 Placebo N= 5256 Djelotvornost cjepiva (%) protiv teškog oblika rotavirusnog gastroenteritisa [95% CI] Genotip
English: Severity of gastro-enteritis was defined according to two different criteria: - the Vesikari 20-point scale, which evaluates the full clinical picture of rotavirus gastro-enteritis by taking into account the severity and duration of diarrhoea and vomiting, the severity of fever and dehydration as well as the need for treatment or - the clinical case definition based on World Health Organization (WHO) criteria
Croatian: Težina gastroenteritisa je bila definirana prema dva različita kriterija: - Vesikari ljestvica od 20 bodova, kojom se procjenjuje ukupna klinička slika rotavirusnog gastroenteritisa uzimajući u obzir težinu i trajanje proljeva i povraćanja, težinu vrućice i dehidracije kao i potrebu za liječenjem ili - klinička definicija slučaja temeljena na kriterijima Svjetske zdravstvene organizacije (SZO)
English: Check that each individual oral tube is not damaged and is still sealed.
Croatian: Provjerite svaku pojedinu tubu za oralnu primjenu kako biste se uvjerili da nije oštećena ili već otvorena.
English: Instructions for administration of the vaccine:
Croatian: Upute za primjenu cjepiva:
English: The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration.
Croatian: Cjepivo je bistra, bezbojna tekućina, bez vidljivih čestica, za oralnu primjenu.
English: Vaccine efficacy during the first year of life progressively increased with increasing disease severity, reaching 100% (95% CI: 84.7;100) for Vesikari scores ≥17.
Croatian: Ove podatke treba interpretirati s oprezom Djelotvornost cjepiva tijekom prve godine života progresivno raste s porastom težine bolesti, dosežući 100% (95% CI: 84.7;100) za rezultate ≥17 po Vesikariju.
English: • Squeeze the liquid gently into the side of the child's mouth, towards the inside of their cheek.
Croatian: • Istisnite tekućinu lagano i postrance u djetetova usta, prema unutarnjoj strani obraza.
English: 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.
Croatian: Na temelju znanstvenih zaključaka za monovalentno cjepivo protiv rotavirusa (živo, oralno), CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) monovalentno cjepivo protiv rotavirusa (živo, oralno) nepromijenjen, uz predložene izmjene informacija o lijeku.
English: The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or diarrhoea.
Croatian: Znakovi gastroenteritisa mogu uključivati mučninu, povraćanje, grčeve u trbuhu ili proljev.
English: Safety in preterm infants
Croatian: Sigurnost primjene u prijevremeno rođene dojenčadi
English: The reconstituted vaccine will appear more turbid than the solvent alone.
Croatian: Rekonstituirano cjepivo bit će mutnije od samog otapala.
English: In the event of either being observed, discard the vaccine.
Croatian: U slučaju uočavanja takvih promjena, cjepivo treba baciti.
English: The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks.
Croatian: Ciklus cijepljenja preporučljivo je dovršiti prije navršenih 16 tjedana života, ali se mora dovršiti do dobi od 24 tjedna.
English: Viral antigen particles detected by ELISA were found in 50% of stools after the first dose of Rotarix lyophilised formulation and 4% of stools after the second dose.
Croatian: Djelići virusnog antigena otkriveni ELISA testom nađeni su u 50% uzoraka stolica nakon prve doze liofiliziranog oblika cjepiva Rotarix i u 4% uzoraka stolica nakon druge doze.
English: PHARMACEUTICAL FORM AND CONTENTS Oral suspension
Croatian: OBLIK I SADRŽAJ Oralna suspenzija
English: Rotarix is available in a pack of 1, 5, 10 or 25.
Croatian: Rotarix je dostupan u pakiranju od 1, 5, 10 ili 25.
English: The extent of protection that Rotarix might provide against other rotavirus strains that have not been circulating in clinical trials is currently unknown.
Croatian: Trenutno nije poznat opseg zaštite koju Rotarix može pružiti protiv drugih sojeva rotavirusa koji nisu cirkulirali u kliničkim studijama.
English: Human rotavirus RIX4414 strain (live, attenuated)*
Croatian: Humani rotavirus soj RIX4414 (živi, atenuirani)*
English: • Hold the tube upright.
Croatian: • Držite tubu uspravno.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (1 ml) contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Nakon rekonstitucije, 1 doza (1 ml) sadrži:
English: Bolivia
Croatian: Bolivija
English: Rotarix is for oral use only.
Croatian: Rotarix se primjenjuje isključivo peroralno.
English: Remove the protective tip cap from the oral applicator.
Croatian: Skinite zaštitni zatvarač vrha s oralnog aplikatora.
English: In a clinical study conducted in preterm infants, born after at least 27 weeks of gestational age, the immunogenicity of Rotarix was assessed in a subset of 147 subjects and showed that Rotarix is immunogenic in this population; 85.7% (95% CI: 79.0;90.9) of subjects achieved serum anti-rotavirus IgA antibody titres ≥ 20U/ml (by ELISA) one month after the second dose of vaccine.
Croatian: U kliničkoj studiji provedenoj u prijevremeno rođenoj dojenčadi, rođenoj s najmanje 27 tjedana gestacijske dobi, imunogenost cjepiva Rotarix je bila procjenjivana u podskupini od 147 ispitanika, te je pokazala da je Rotarix imunogeničan u ovoj populaciji; 85,7% (95% CI: 79,0; 90,9) ispitanika ostvarilo je titar IgA protutijela protiv rotavirusa u serumu ≥20 U/ml (ELISA) jedan mjesec nakon druge doze cjepiva.
English: The mixed vaccine will appear more turbid than the solvent alone.
Croatian: Pomiješano cjepivo bit će mutnije od samog otapala.
English: Human rotavirus RIX4414 strain (live, attenuated)
Croatian: Humani rotavirus soj RIX4414 (živi, atenuirani)
English: It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on longer periods of follow-up (see section 4.4).
Croatian: Na temelju duljih razdoblja praćenja, ostaje nejasno utječu li cjepiva protiv rotavirusa na sveukupnu incidenciju intususcepcije (vidjeti dio 4.4).
English: To separate one oral tube from the others starting at one end: a) Hold the tab of one of the end oral tubes to separate it from the others.
Croatian: Da biste odvojili jednu od tuba za oralnu primjenu počevši od one s kraja trake: a) Uhvatite jezičak jedne od tuba za oralnu primjenu koja se nalazi na kraju trake.
English: Rotavirus vaccine, live
Croatian: Cjepivo protiv rotavirusa, živo
English: • Once the tube is open check the liquid is clear,
Croatian: • Nakon što je tuba otvorena provjerite je li tekućina bistra, bez ikakvih čestica u njoj.
English: Powder: dextran, sucrose, sorbitol (see also section 2, Rotarix contains sucrose and sorbitol), amino acids, Dulbecco's Modified Eagle Medium (DMEM) Solvent: calcium carbonate, xanthan gum, sterile water
Croatian: Prašak: dekstran, saharoza, sorbitol (pogledajte također dio 2 “Rotarix sadrži saharozu i sorbitol“), aminokiseline, Dulbeccova modificirana Eagleova podloga (DMEM) Otapalo: kalcijev karbonat, ksantanska guma, sterilna voda
English: Date of first authorisation: 21 February 2006 Date of latest renewal: 14 January 2016
Croatian: Datum posljednje obnove odobrenja: 14. siječnja 2016.