FrancophonIA/ELRC3.0 huggingface dataset:
English: 3, 4 months Czech Republic
Croatian: 3, 4 mjeseca Republika
English: Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy of Rotarix.
Croatian: Ne očekuje se utjecaj asimptomatskih i blažih simptomatskih HIV infekcija na sigurnost i djelotvornost cjepiva Rotarix.
English: Transfer adapter for reconstitution (1/dose) in the following pack sizes:
Croatian: Nastavak za prijenos pri rekonstituciji (1/dozi) u sljedećim veličinama pakiranja:
English: These data should be interpreted with caution # The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very small (1 case in the Rotarix group and 2 cases in the placebo group)
Croatian: Ove podatke treba interpretirati s oprezom # Broj slučajeva na kojima se temeljila procjena djelotvornosti protiv G4P[8] bio je vrlo malen (1 slučaj u Rotarix skupini i 2 slučaja u placebo skupini)
English: The safety profile was similar between Rotarix and placebo recipients.
Croatian: Sigurnosni profil je bio sličan između onih koji su primili Rotarix i placebo.
English: Therefore, breast-feeding may be continued during the vaccination schedule.
Croatian: Stoga se tijekom ciklusa cijepljenja može nastaviti s dojenjem.
English: - Do not use any of the oral tubes on the connecting bar if you notice anything unusual.
Croatian: - Nemojte upotrijebiti nijednu od tuba za oralnu primjenu na spojnoj traci ako primijetite bilo što neobično.
English: Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix.
Croatian: Na temelju dokaza prikupljenih u kliničkim ispitivanjima, dojenje ne smanjuje zaštitu protiv rotavirusnog gastroenteritisa koju pruža Rotarix.
English: 1300 Wavre Belgium
Croatian: 1300 Wavre
English: There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses or growth retardation.
Croatian: Nema podataka o sigurnosti i djelotvornosti cjepiva Rotarix u dojenčadi s gastrointestinalnim bolestima ili zaostajanjem u rastu.
English: Rotarix is available in a pack of 50 tubes.
Croatian: Rotarix je dostupan u pakiranju od 50 tuba.
English: Protective efficacy of the liquid formulation
Croatian: Zaštitna djelotvornost tekućeg oblika
English: Effectiveness after 2 doses in preventing RVGE leading to hospitalization
Croatian: Učinkovitost nakon 2 doze u prevenciji RVGE koji vodi do hospitalizacije
English: There should be an interval of at least 4 weeks between doses.
Croatian: Razmak između doza mora biti najmanje 4 tjedna.
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 safety studies indicate an increased risk of intussusception, mostly within 7 days after rotavirus vaccination (see section 4.8).
Croatian: Iz predostrožnosti, zdravstveni djelatnici moraju pratiti pojavu bilo kojih simptoma koji bi upućivali na pojavu intususcepcije (jaka bol u abdomenu, neprestano povraćanje, pojava krvi u stolici, nadutost abdomena i/ili visoka vrućica) jer podaci iz opservacijskih ispitivanja sigurnosti ukazuju na povećan rizik od intususcepcije, većinom unutar 7 dana nakon cijepljenja protiv rotavirusa (vidjeti dio 4.8).
English: Under no circumstance should this vaccine be administered by injection.
Croatian: Ovo cjepivo se ni pod kojim okolnostima ne smije primijeniti injekcijom.
English: • Turn the cap upside down (180°).
Croatian: • Preokrenite zatvarač (za 180°).
English: Do not inject!
Croatian: Nemojte injicirati!
English: Rotarix should be administered with caution to individuals with immunodeficient close contacts, such as individuals with malignancies, or who are otherwise immunocompromised or individuals receiving immunosuppressive therapy.
Croatian: Rotarix se mora primijeniti s oprezom u pojedinaca s imunodeficijentnim bliskim kontaktima, kao što su pojedinci s malignim bolestima ili koji su na neki drugi način imunokompromitirani ili pojedinci koji se liječe imunosupresivnim lijekovima.
English: • children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their stools.
Croatian: • djeca s rijetkom nasljednom bolesti koja se zove teška kombinirana imunodeficijencija mogu imati upalu sluznice želuca ili crijeva (gastroenteritis) i izlučivati virus iz cjepiva u stolici.
English: Middle Income Countries
Croatian: Države sa srednjim prihodima
English: §NOTE : Impact studies are meant to establish a temporal relationship but not a causal relationship between the disease and vaccination.
Croatian: §NAPOMENA: namjena ispitivanja utjecaja je ustanoviti vremensku, a ne uzročnu povezanost između bolesti i cijepljenja.
English: There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa.
Croatian: Nema podataka o sigurnosti, imunogenosti ili djelotvornosti kad se u prvoj dozi primjenjuje Rotarix, a neko drugo cjepivo protiv rotavirusa u drugoj dozi ili obrnuto.
English: Date of latest renewal: 14 January 2016
Croatian: Datum posljednje obnove odobrenja: 14 siječnja 2016.
English: Protective efficacy in Latin America
Croatian: Zaštitna djelotvornost u Latinskoj Americi
English: A clinical study performed in Europe evaluated Rotarix given according to different European schedules (2, 3 months; 2, 4 months; 3, 4 months; 3, 5 months) in 4,000 subjects.
Croatian: Klinička studija provedena u Europi procjenjivala je Rotarix primijenjen prema različitim europskim rasporedima cijepljenja (2, 3 mjeseca; 2, 4 mjeseca; 3, 4 mjeseca; 3, 5 mjeseci) u 4000 ispitanika.
English: Up to 6 additional cases per 100,000 infants have been observed in these countries against a background incidence of 25 to 101 per 100,000 infants (less than one year of age) per year, respectively.
Croatian: U tim zemljama zabilježeno je do 6 dodatnih slučajeva na 100 000 dojenčadi na osnovnu incidenciju od 25 odnosno 101 slučaja na 100 000 dojenčadi (mlađe od jedne godine) godišnje.
English: Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus.
Croatian: Rotarix ne pruža zaštitu od gastroenteritisa uzrokovanog drugim patogenima osim rotavirusa.
English: Expiry date: DD/MM/YY
Croatian: Rok valjanosti: DD/MM/GG
English: • abdominal pain (see also below for signs of very rare side effects of intussusception)
Croatian: • bol u trbuhu (pogledajte ispod znakove vrlo rijetke nuspojave intususcepcije)
English: • Keep the cap - you need this to pierce the membrane.
Croatian: • Zadržite zatvarač - trebat će vam za probijanje membrane.
English: • if 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 prethodno imalo intususcepciju (začepljenje crijeva koje nastaje kada se jedan dio crijeva uvuče unutar drugog dijela).
English: • One oral tube delivers one dose of vaccine.
Croatian: • Jednom tubom za oralnu primjenu se primjenjuje jedna doza cjepiva.
English: • Submit an application at the latest in 2020 to amend the particulars of the marketing authorisation in order to render the medicinal product PCV-free.
Croatian: • Predati zahtjev za izmjenu Odobrenja za stavljanje lijeka u promet za cjepivo bez PCV-a najkasnije u 2020.
English: • Very rare: intussusception (part of the intestine gets blocked or twisted).
Croatian: • vrlo rijetko: intususcepciju (uvrtanje ili začepljenje dijela tankog crijeva).
English: Calcium carbonate Xanthan gum Sterile water
Croatian: Otapalo kalcijev karbonat ksantanska guma sterilna voda
English: Protective efficacy in Africa
Croatian: Zaštitna djelotvornost u Africi
English: With the oral applicator still attached, shake the glass container and examine it for complete suspension of the powder.
Croatian: Dok je oralni aplikator još spojen, protresite stakleni spremnik i provjerite je li se prašak u potpunosti suspendirao.
English: In a total of twenty-three clinical trials, approximately 106,000 doses of Rotarix (lyophilised or liquid formulation) were administered to approximately 51,000 infants.
Croatian: U ukupno dvadeset i tri klinička ispitivanja primijenjeno je oko 106 000 doza cjepiva Rotarix (liofilizirane ili tekuće formulacije) u oko 51 000 dojenčadi.
English: Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
Croatian: Osobe s neliječenom kongenitalnom malformacijom gastrointestinalnog trakta koja bi mogla biti predispozicija za intususcepciju.
English: This was supported by a very short time-to-onset (from immediate onset to a few hours), the absence of coadministered vaccines or drugs, and the rapid resolution of the event, with or without treatment.
Croatian: Tu povezanost podupiru vrlo kratko vrijeme do nastupa (od neposredno nakon cijepljenja do nekoliko sati kasnije), izostanak istodobne primjene drugih cjepiva ili lijekova te brzo povlačenje događaja, uz liječenje ili bez njega.
English: As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the rotavirus infections it is intended to prevent.
Croatian: Kao i sva ostala cjepiva, Rotarix možda neće u potpunosti zaštititi sve cijepljene osobe od infekcije rotavirusom za čije je spriječavanje namijenjen.
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 vrlo rano rođene dojenčadi (rođene u ili prije 28 tjedna gestacijske dobi) produljeni razmaci između dva udisaja u odnosu na uobičajene razmake mogu se pojaviti tijekom 2-3
English: Besides, the SmPC of immunosuppressive therapies, such as adalimumab, infliximab, includes a recommendation to defer live vaccine administration in infants who were exposed in utero to these treatments.
Croatian: Osim toga, sažetak opisa svojstava lijeka za imunosupresivne lijekove, kao što su adalimumab i infliksimab, uključuje preporuku da se odgodi primjena živih cjepiva u dojenčadi koja je tim lijekovima bila izložena in utero.
English: When Rotarix is given to your child for the first dose, it is recommended that your child also receives Rotarix (and not another rotavirus vaccine) for the second dose.
Croatian: Ako je Vaše dijete dobilo prvu dozu cjepiva Rotarix, preporučuje se da se i u drugoj dozi primijeni Rotarix (a ne neko drugo cjepivo protiv rotavirusa).
English: Dulbecco's Modified Eagle Medium (DMEM)
Croatian: Dulbeccova modificirana Eagleova podloga (DMEM)
English: Safety in infants with human immunodeficiency (HIV) infection In a clinical study, 100 infants with HIV infection were administered Rotarix or placebo.
Croatian: Sigurnost primjene u dojenčadi s infekcijom virusom humane imunodeficijencije (HIV-om) U kliničkoj studiji, kod 100 dojenčadi s HIV infekcijom primijenjen je Rotarix ili placebo.
English: • inflammation of the skin
Croatian: • upala kože
English: Contents of the pack and other information What Rotarix contains - The active substances are: Human rotavirus RIX4414 strain (live, attenuated)*
Croatian: Sadržaj pakiranja i druge informacije Što Rotarix sadrži - Djelatne tvari su: Humani rotavirus soj RIX4414 (živi, atenuirani)*
English: Clinical studies demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected.
Croatian: Kliničke studije su pokazale da nije bilo promjene imunološkog odgovora niti sigurnosnog profila primijenjenih cjepiva.
English: This product contains sucrose 1,073 mg (see section 4.4).
Croatian: Cjepivo sadrži 1073 mg saharoze (vidjeti dio 4.4).
English: The following side effects may happen with this vaccine:
Croatian: Sljedeće nuspojave se mogu javiti kod primjene ovog cjepiva:
English: There is also a transfer adapter which allows easy transfer of the solvent into the glass container containing the powder for mixing the different components of the vaccine.
Croatian: U pakiranju se nalazi i nastavak za prijenos koji omogućava jednostavan prijenos otapala u stakleni spremnik s praškom kako bi se različite komponente cjepiva mogle pomiješati.
English: Put back in fridge immediately
Croatian: Odmah vratite u hladnjak
English: High Income countries
Croatian: Države s visokim prihodima
English: However, in the unlikely event that an infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.
Croatian: Međutim, u malo vjerojatnom slučaju da dojenče ispljune ili regurgitira većinu doze cjepiva, može se dati jedna zamjenska doza tijekom istog posjeta liječniku.
English: It is good clinical practice that vaccination should be preceded by a review of the medical history especially with regard to the contraindications and by a clinical examination.
Croatian: Dobra klinička praksa nalaže da prije cijepljenja treba provjeriti anamnezu, posebice u vezi kontraindikacija te obaviti klinički pregled.
English: Effectiveness after 2 doses in preventing RVGE leading to hospitalization Countries
Croatian: Učinkovitost nakon 2 doze u prevenciji RVGE koji vodi do hospitalizacije Zemlje
English: - Do not use the affected oral tube if you notice anything unusual.
Croatian: - Nemojte upotrijebiti pojedinu tubu za oralnu primjenu ako na njoj primijetite bilo što neobično.
English: In a pooled analysis from seventeen placebo-controlled clinical trials (Europe, North America, Latin America, Asia, Africa) including trials in which Rotarix was co-administered with routine paediatric vaccines (see section 4.5), the following adverse reactions (collected 31 days post-vaccination) were considered as possibly related to vaccination.
Croatian: U skupnoj analizi iz sedamnaest placebom kontroliranih kliničkih ispitivanja (Europa, Sjeverna Amerika, Latinska Amerika, Azija, Afrika) uključujući ispitivanja u kojima je Rotarix bio primijenjen istodobno s drugim rutinskim pedijatrijskim cjepivima (vidjeti dio 4.5), za sljedeće nuspojave (prikupljene kroz 31 dan nakon cijepljenja), povezanost s cijepljenjem je ocijenjena kao moguća.
English: Administration of Rotarix may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.
Croatian: U takve dojenčadi može se uz oprez razmotriti primjena cjepiva Rotarix, kad prema mišljenju liječnika uskraćivanje cijepljenja predstavlja veći rizik.
English: Immune response in preterm infants
Croatian: Imunološki odgovor u prijevremeno rođene dojenčadi
English: Remove the plastic cover from the glass container containing the powder
Croatian: Skinite plastični pokrov sa staklenog spremnika s praškom
English: • This vaccine is given orally - straight from the tube.
Croatian: • Ovo se cjepivo daje u usta - izravno iz tube.
English: In order to strengthen the current warning on administration of Rotarix to infants who have known or suspected immunodeficiency, it is recommended to update the current warning.
Croatian: Kako bi se dodatno naglasilo postojeće upozorenje o primjeni cjepiva Rotarix u dojenčadi kod koje se zna ili sumnja na imunodeficijenciju, preporučuje se ažurirati trenutno upozorenje.
English: The first dose was administered from 6 weeks after birth.
Croatian: Prva doza cjepiva je bila primijenjena u dobi od 6 tjedana nakon rođenja.
English: • Check the liquid is clear and colourless, without any particles in it.
Croatian: • Provjerite je li tekućina bistra i bezbojna, bez ikakvih čestica u njoj.
English: • There is a small spike inside the top of the cap - in the centre.
Croatian: • S unutarnje strane vrha zatvarača nalazi se mali šiljak - u sredini.
English: 1 dose (1.5 ml)
Croatian: 1 doza (1,5 ml)
English: • This vaccine is given orally straight from an individual tube.
Croatian: • Ovo se cjepivo daje u usta izravno iz pojedinačne tube.
English: • if your child was born with a malformation of the gut that could lead to intussusception.
Croatian: • ako je Vaše dijete rođeno s poremećajem crijeva koje bi moglo dovesti do intususcepcije.
English: Countries Period
Croatian: Zemlje Period
English: The signs may include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever.
Croatian: Znakovi uključuju jaku bol u trbuhu, neprestano povraćanje, pojavu krvi u stolici, nadutost trbuha i/ili visoku vrućicu.
English: For subjects with a predisposition for intussusception, see section 4.3.
Croatian: Za osobe s predispozicijom intususcepcije, vidjeti dio 4.3.
English: Administration of Rotarix to infants who have known or suspected immunodeficiency, including in utero exposure to an immunosuppressive treatment, should be based on careful consideration of potential benefits and risks.
Croatian: Primjena cjepiva Rotarix u dojenčadi za koju se zna ili sumnja na imunodeficijenciju, uključujući izloženost imunosupresivnoj terapiji in utero, mora se temeljiti na pažljivom razmatranju mogućih koristi i rizika.
English: Side effects that have been reported during marketed use of Rotarix include:
Croatian: Nuspojave koje su prijavljene nakon stavljanja cjepiva Rotarix u promet uključuju:
English: A clinical study performed in Latin America evaluated Rotarix in more than 20,000 subjects.
Croatian: Americi procjenjivala je Rotarix u više od 20 000 osoba.
English: Clinical protection was assessed in the ATP cohort for efficacy, which includes all subjects from the ATP cohort for safety who entered into the concerned efficacy follow-up period.
Croatian: Klinička zaštita procjenjivana je u kohorti po protokolu za djelotvornost, koja je uključivala sve osobe u kohorti po protokolu sigurnosti koje su ušle u period praćenja djelotvornosti.
English: The oral applicator containing the reconstituted vaccine should be shaken gently again before oral administration.
Croatian: Oralni aplikator koji sadrži rekonstituirano cjepivo treba ponovno nježno protresti prije oralne primjene.
English: g) Pull it from the connecting bar.
Croatian: g) Povucite je kako bi se odvojila od spojne trake.
English: To administer the vaccine orally:
Croatian: Da biste oralno primijenili cjepivo:
English: Similar rates of other adverse events were observed in Rotarix and placebo recipients.
Croatian: Slične stope ostalih štetnih događaja zabilježene su u onih koji su primili Rotarix i placebo.
English: Rotarix may be given with the same posology to preterm infants born after at least 27 weeks of gestational age (see sections 4.8 and 5.1).
Croatian: Isti režim doziranja cjepiva Rotarix se može primijeniti i kod prijevremeno rođene dojenčadi rođene nakon najmanje 27. tjedna gestacijske dobi (vidjeti dijelove 4.8 i 5.1).
English: Section 4.4 of the SmPC of Rotarix includes a warning on administration of Rotarix to infants who have known or suspected immunodeficiency.
Croatian: Dio 4.4 sažetka opisa svojstava lijeka uključuje upozorenje o primjeni cjepiva Rotarix u dojenčadi kod koje se zna ili sumnja na imunodeficijenciju.
English: The shaken suspension will appear as a turbid liquid with a slow settling white deposit
Croatian: Protresena suspenzija izgledat će kao mutna tekućina s bijelim talogom koji se polako taloži
English: Rotarix contains sucrose and sorbitol
Croatian: Rotarix sadrži saharozu i sorbitol
English: To open the separated oral tube: d) Keep the separated oral tube held upright.
Croatian: Da biste otvorili odvojenu tubu za oralnu primjenu: d) Držite odvojenu tubu za oralnu primjenu u uspravnom položaju.
English: Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus infection.
Croatian: Rotarix je virusno cjepivo, koje sadrži živi oslabljeni ljudski rotavirus i koje pomaže zaštititi Vaše dijete starije od 6 tjedana od gastroenteritisa (proljeva i povraćanja) uzrokovanih infekcijom rotavirusom.
English: Instructions for administration of the vaccine in a pre-filled oral applicator:
Croatian: Upute za primjenu cjepiva u napunjenom oralnom aplikatoru:
English: * In these studies, the point estimates and confidence intervals were respectively: 100% (95% CI:1,858.0;100), 100% (95% CI: 21.1;100), 45.4% (95% CI: -81.5;86.6), 74.7 (95% CI :-386.2;99.6).
Croatian: * Točkovna procjena i intervali pouzdanosti u tim ispitivanjima bili su: 100% (95% CI: -1,858,0;100), 100% (95% CI: 21,1;100), 45,4% (95% CI: -81,5;86,6), 74,7 (95% CI :-386,2;99,6).
English: Adverse reactions reported are listed according to the following frequency:
Croatian: Prijavljene nuspojave su navedene prema sljedećoj učestalosti:
English: The safety profile presented below is based on data from clinical trials conducted with either the lyophilised or the liquid formulation of Rotarix.
Croatian: Niže opisan sigurnosni profil temelji se na podacima iz kliničkih ispitivanja koja su provedena bilo s liofiliziranom, bilo s tekućom formulacijom cjepiva Rotarix.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for rotavirus vaccine monovalent (live, oral), the scientific conclusions of CHMP are as follows:
Croatian: (PSUR) za monovalentno cjepivo protiv rotavirusa (živo, oralno), znanstveni zaključci CHMP-a su sljedeći:
English: - Multi-monodose (5 single dose) squeezable tube presentation connected by a bar: 2 years The vaccine should be used immediately after opening.
Croatian: - Više jednodoznih tuba za istiskivanje (5 pojedinačnih doza) spojenih trakom: 2 godine Cjepivo treba primijeniti odmah nakon otvaranja.
English: * Not statistically significant (P ≥ 0.05).
Croatian: * nije statistički značajno (P ≥ 0,05).
English: Do not inject.
Croatian: Nemojte injicirati.
English: Since the immune response observed after 2 doses of Rotarix liquid formulation was comparable to the immune response observed after 2 doses of Rotarix lyophilised formulation, the levels of vaccine efficacy observed with the lyophilised formulation can be extrapolated to the liquid formulation.
Croatian: S obzirom da je imunološki odgovor uočen nakon 2 doze tekućeg oblika cjepiva Rotarix usporediv s imunološkim odgovorom uočenim nakon primjene 2 doze liofiliziranog oblika cjepiva Rotarix, razina djelotvornosti cjepiva uočena s liofiliziranim oblikom može se ekstrapolirati na tekući oblik.
English: Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1).
Croatian: Rotarix je indiciran za aktivnu imunizaciju dojenčadi u dobi od 6. do 24. tjedna za prevenciju gastroenteritisa izazvanog infekcijom rotavirusom (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Unused oral tubes that are still attached to the connecting bar must be put back in the fridge immediately after an oral tube has been used.
Croatian: preostale neupotrijebljene tube koje su još pričvršćene za spojnu traku moraju se odmah vratiti u hladnjak, kako bi se mogle iskoristiti za sljedeće cijepljenje.
English: Protective efficacy in Europe
Croatian: Zaštitna djelotvornost u Europi
English: • Give the vaccine straight away.
Croatian: • Odmah primijenite cjepivo.
English: ♦ Common (These may occur with up to 1 in 10 doses of the vaccine):
Croatian: ♦ Često (mogu se javiti u do 1 na 10 doza cjepiva):
English: If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, contact your doctor before receiving this vaccine.
Croatian: Ako su Vam rekli da Vaše dijete ne podnosi neke šećere, prije primjene cjepiva o tome obavijestite liječnika.
English: PHARMACEUTICAL FORM Oral suspension.
Croatian: OBLIK Oralna suspenzija.
English: Taiwan
Croatian: Tajvan