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.
Slovenian: Študije vpliva s cepivom Rotarix v Panami, Braziliji in Mehiki so pokazale, da se je v 2 do 4 letih po uvedbi cepiva umrljivost zaradi driske zaradi vseh vzrokov pri otrocih, mlajših od 5 let, zmanjšala od 17 % do 73 %.
English: LIST OF EXCIPIENTS Powder: sucrose, sorbitol See the package leaflet for further information
Slovenian: SEZNAM POMOŽNIH SNOVI Prašek: saharoza, sorbitol Za dodatne informacije glejte navodilo za uporabo.
English: Side effects that have been reported during marketed use of Rotarix include:
Slovenian: Med neželenimi učinki, opisanimi med obdobjem, ko je cepivo Rotarix na trgu, so:
English: The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or diarrhoea.
Slovenian: Znaki gastroenteritisa lahko vključujejo slabost, bruhanje, želodčne krče ali drisko.
English: Severe†
Slovenian: Hud†
English: D. Store remaining doses in the fridge immediately
Slovenian: D. Neporabljene odmerke takoj shranite nazaj v hladilnik
English: 6.6 Special precautions for disposal and other handling The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Cepivo je bistra in brezbarvna tekočina brez vidnih delcev za peroralno uporabo.
English: There are no restrictions on the infant's consumption of food or liquid, either before or after vaccination.
Slovenian: Glede uživanja hrane ali tekočine pred ali po aplikaciji cepiva ni omejitev.
English: When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the most commonly occurring types of rotavirus.
Slovenian: Po cepljenju imunski sistem (obrambni mehanizem telesa) ustvari protitelesa proti najpogostejšim serotipom rotavirusov.
English: Section 4.4 of the SmPC of Rotarix includes a warning on administration of Rotarix to infants who have known or suspected immunodeficiency.
Slovenian: V poglavju 4.4 SmPC-ja cepiva Rotarix je opozorilo o dajanju cepiva Rotarix dojenčkom z znano ali s sumom na imunsko pomanjkljivost.
English: Official batch release:
Slovenian: Uradna sprostitev serije:
English: PHARMACEUTICAL FORM AND CONTENTS Oral suspension
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Peroralna suspenzija
English: Hypersensitivity after previous administration of rotavirus vaccines.
Slovenian: Preobčutljivost po predhodni aplikaciji cepiv proti rotavirusom.
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.
Slovenian: Če veste, da vaš otrok ne prenaša določenih sladkorjev, o tem obvestite zdravnika, preden otrok prejme cepivo.
English: Instructions for reconstitution and administration of the vaccine:
Slovenian: Navodila za rekonstitucijo in aplikacijo cepiva:
English: US
Slovenian: ZDA
English: 2, 3 to 4 months
Slovenian: 2. in 3. do 4. mesec
English: To open the tube
Slovenian: Odpiranje tube
English: Check the membrane has been pierced
Slovenian: Preverite, da ste prebodli membrano
English: The solvent is a turbid liquid with a slow settling white deposit and a colourless supernatant.
Slovenian: Vehikel je motna tekočina s počasi usedajočo se belo usedlino in brezbarvnim supernatantom.
English: • Check the liquid is clear and colourless, without any particles in it.
Slovenian: • Preverite, da je tekočina bistra in brezbarvna ter da v njej ni delcev.
English: Rotarix contains sucrose and sorbitol
Slovenian: Cepivo Rotarix vsebuje saharozo in sorbitol
English: In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.
Slovenian: Če otrok izpljune ali regurgitira večino odmerka cepiva, lahko ob istem obisku prejme še en nadomestni odmerek.
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).
Slovenian: (6) Med preiskovanci, ki niso prejeli celotnega zaporedja cepljenja, je bila učinkovitost po enem odmerku v razponu od 51 % (95 % IZ: 26;67 v El Salvadorju) do 60 % (95 % IZ: 37;75 v Braziliji).
English: As always, please take care to wash your hands thoroughly after changing soiled nappies.
Slovenian: Po vsakem menjavanju plenic si temeljito umijte roke.
English: There are no data on the use of Rotarix during pregnancy and lactation.
Slovenian: O uporabi cepiva Rotarix med nosečnostjo in dojenjem ni podatkov.
English: The shaken suspension will appear as a turbid liquid with a slow settling white deposit
Slovenian: Pretresena suspenzija je motna tekočina s počasi usedajočo se belo usedlino.
English: The vaccine efficacy against severe rotavirus gastro-enteritis during the first year of life was 61.2% (95% CI: 44.0;73.2).
Slovenian: Učinkovitost cepiva proti hudemu rotavirusnemu gastroenteritisu v prvem letu življenja je bila 61,2 % (95 % IZ: 44,0;73,2).
English: - This vaccine has been prescribed for your child only.
Slovenian: - Cepivo je bilo predpisano vašemu otroku osebno in ga ne smete dajati drugim.
English: Malawi
Slovenian: Malavi
English: Safety in preterm infants
Slovenian: Varnost pri nedonošenčkih
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:
Slovenian: Učinkovitost zaščite cepiva proti hudemu rotavirusnemu (RV) gastroenteritisu, pri katerem je potreben sprejem v bolnišnico in/ali rehidracijsko zdravljenje v zdravstvenih ustanovah, in genotipsko specifična učinkovitost cepiva po prejemu dveh odmerkov cepiva Rotarix sta predstavljeni v spodnji preglednici:
English: Protective efficacy of the liquid formulation
Slovenian: Učinkovitost zaščite tekoče oblike cepiva
English: Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person.
Slovenian: Rotavirusi se po stiku z blatom okužene osebe preko rok zlahka zanesejo v usta.
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.
Slovenian: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za cepivo proti rotavirusom, živo odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) cepivo proti rotavirusom, živo nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
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.
Slovenian: O dajanju cepiva Rotarix takšnim otrokom mora zdravnik skrbno razmisliti, še posebej, če meni, da bi bilo necepljenje povezano z večjim tveganjem.
English: ♦ Common (These may occur with up to 1 in 10 doses of the vaccine):
Slovenian: ♦ Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 na 10 odmerkov cepiva):
English: Intussusception (see section 4.4)
Slovenian: Zelo redki invaginacija (glejte poglavje 4.4)
English: Ask your pharmacist how to throw away medicines your child no longer uses.
Slovenian: O načinu odstranjevanja cepiva, ki ga vaš otrok ne potrebuje več, se posvetujte s farmacevtom.
English: The vaccine (1.5 ml liquid) will be given orally.
Slovenian: Otrok bo cepivo (1,5 ml tekočine) prejel peroralno (skozi usta).
English: Rotarix is available in a pack of 1, 5, 10 or 25.
Slovenian: Cepivo Rotarix je na voljo v pakiranjih po 1, 5, 10 ali 25.
English: Instructions for administration of the vaccine in a pre-filled oral applicator:
Slovenian: Navodila za aplikacijo cepiva v napolnjenem peroralnem aplikatorju:
English: However, some children become very ill with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation.
Slovenian: Večina otrok z rotavirusno drisko ozdravi sama po sebi, nekateri otroci pa resno zbolijo in močno bruhajo, imajo hudo drisko, pojavi pa se lahko tudi smrtno nevarna izguba tekočin, ki zahteva sprejem v bolnišnico.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI) ODGOVOREN (ODGOVORNI)
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;
Slovenian: V prvem letu so pri prejemnikih cepiva Rotarix zabeležili značilno manj primerov hudega rotavirusnega gastroenteritisa, ki ga je povzročil krožeči divji tip RV, kot pri prejemnikih placeba, in sicer od 2. tedna po 2. odmerku do enega leta starosti (0,0 % v primerjavi z 0,3 %), pri čemer je bila učinkovitost cepiva 100 % (95 % IZ: 72,2; 100).
English: The vaccine contains sucrose and sorbitol as excipients.
Slovenian: Cepivo vsebuje saharozo in sorbitol kot pomožni snovi.
English: After reconstitution: The reconstituted vaccine is slightly more turbid than the solvent and is milky white in appearance.
Slovenian: Rekonstituirano cepivo je nekoliko bolj motno kot vehikel in mlečno belo.
English: • if your child has diarrhoea or is vomiting.
Slovenian: • če ima drisko ali bruha.
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).
Slovenian: Klinična študija, izvedena v Afriki (cepivo Rotarix: n = 2.974; placebo: n = 1.443), je ovrednotila cepivo Rotarix dano v starosti približno 10 in 14 tednov (2 odmerka) ali v starosti približno 6, 10 in 14 tednov (3 odmerki).
English: Administration of Rotarix should be postponed in subjects suffering from acute severe febrile illness.
Slovenian: Cepljenje s cepivom Rotarix je treba odložiti pri osebah, ki prebolevajo hudo akutno vročinsko bolezen.
English: Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus.
Slovenian: Cepivo Rotarix ne ščiti pred gastroenteritisom, ki ga povzročajo drugi povzročitelji in ne rotavirusi.
English: Position the cap to open the tube
Slovenian: Namestitev zaporke za odprtje tube
English: The first dose may be administered from the age of 6 weeks.
Slovenian: Prvi odmerek lahko apliciramo od starosti 6 tednov dalje.
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.
Slovenian: Med prvim letom življenja se učinkovitost cepiva progresivno povečuje s povečevanjem resnosti bolezni in pri oceni ≥ 17 po Vesikariju doseže 100 % (95% interval zaupanja: 84,7;100).
English: A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastro-enteritis has not been established.
Slovenian: Povezave med pojavom protiteles zaradi cepljenja s cepivom proti rotavirusom in zaščito pred rotavirusnim gastroenteritisom niso dokazali.
English: † Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale
Slovenian: † Hud gastroenteritis je bil opredeljen kot ocena ≥ 11 na Vesikarijevi lestvici
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
Slovenian: Resnost gastroenteritisa je bila definirana po dveh različnih kriterijih: - z 20-točkovno Vesikarijevo lestvico, ki upošteva tako celotno klinično sliko rotavirusnega gastroenteritisa (resnost in trajanje driske ter bruhanja, resnost povišane telesne temperature in dehidracije) kot tudi potrebo po zdravljenju; ali
English: The efficacy against severe RV gastro-enteritis requiring hospitalisation was 100% (95% CI: 72.4; 100).
Slovenian: Učinkovitost proti hudem RV gastroenteritisu, ki je zahteval sprejem v bolnišnico, je bila 100 % (95 % IZ: 72,4; 100).
English: In two comparative controlled trials, vaccine shedding after vaccination with Rotarix liquid formulation was comparable to that observed after vaccination with Rotarix lyophilised formulation.
Slovenian: V dveh primerjalnih nadzorovanih preskušanjih je bilo izločanje vakcinalnega virusa po cepljenju s cepivom Rotarix v tekoči obliki primerljivo z izločanjem vakcinalnega virusa po cepljenju s cepivom Rotarix v liofilizirani obliki.
English: Rotarix is supplied as clear and colourless liquid in 5 single dose squeezable tubes (5 x 1.5 ml) connected by a bar.
Slovenian: Cepivo Rotarix je bistra in brezbarvna tekočina v 5-ih enoodmernih stisljivih tubah (5 x 1,5 ml), ki so med seboj povezane s ploščico.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Slovenian: ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (učinkovin)
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.
Slovenian: Amerika, Latinska Amerika, Azija, Afrika), vključno s preskušanji, v katerih so cepivo Rotarix uporabili sočasno z običajno rabljenimi pediatričnimi cepivi (glejte poglavje 4.5), so naslednje neželene učinke (zbrane 31 dni po cepljenju) ocenili kot morebiti povezane s cepljenjem.
English: Transfer the entire content of the oral applicator into the glass container containing the powder
Slovenian: Celotno vsebino peroralnega aplikatorja iztisnite v stekleničko s praškom.
English: Instructions for administration of the vaccine:
Slovenian: Navodila za aplikacijo cepiva:
English: Mexico
Slovenian: Mehika
English: This vaccine is intended for oral administration only.
Slovenian: To cepivo je namenjeno izključno za peroralno aplikacijo.
English: Read all of this leaflet carefully before your child receives this vaccine because it contains important information for you.
Slovenian: Preden bo vaš otrok prejel cepivo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks.
Slovenian: Najbolje je, da cepljenje z obema odmerkoma opravimo pred dopolnjenim 16. tednom starosti, vsekakor pa mora biti cepljenje z obema odmerkoma zaključeno pred dopolnjenim 24. tednom starosti.
English: Rotarix is available in a pack of 1, 10 or 50.
Slovenian: Cepivo Rotarix je na voljo v pakiranjih po 1, 5, 10 ali 50.
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.
Slovenian: Kljub temu pa lahko, v sicer malo verjetnih primerih, ko otrok izpljune ali regurgitira večino odmerka cepiva, ob istem obisku apliciramo enkraten nadomestni odmerek.
English: 1st year of life Rotarix N=2,572 Placebo N=1,302
Slovenian: Prvo leto življenja Rotarix n=2.572 Placebo n=1.302
English: Bolivia
Slovenian: Bolivija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/330/012 - pack of 50 tubes 13.
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/330/012 - pakiranje s 50 tubami
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)
Slovenian: # Število oseb, na katerih temelji ocena učinkovitosti proti G4P[8] je zelo majhno (1 oseba v skupini, ki je prejela cepivo Rotarix in 2 osebi v skupini, ki je prejela placebo).
English: 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).
Slovenian: Klinična študija, ki so jo izvedli v Aziji (Hongkong, Singapur in Tajvan) (celotna cepljena kohorta: Rotarix: n = 5.359, placebo: n = 5.349), je ocenila cepivo Rotarix, uporabljeno po različnih shemah (2. in 4. mesec starosti, 3. in 4. mesec starosti).
English: After reconstitution, the vaccine contained in the oral applicator should be administered promptly.
Slovenian: Po rekonstituciji je treba cepivo v peroralnem aplikatorju uporabiti takoj.
English: NA(7)
Slovenian: NP (7)
English: • if your child has a rare inherited illness which affects their immune system called Severe Combined Immunodeficiency (SCID).
Slovenian: • če ima redko dedno bolezen, imenovano huda kombinirana imunska pomanjkljivost (SCID), ki prizadene njegov imunski sistem;
English: Oral suspension in pre-filled oral applicator 1 pre-filled oral applicator 1 dose (1.5 ml)
Slovenian: Peroralna suspenzija v napolnjenem peroralnem aplikatorju 1 napolnjen peroralni aplikator 1 odmerek (1,5 ml)
English: Taiwan were calculated using combined rotavirus-negative hospital control and non-diarrhoea hospital control participants).
Slovenian: (4) Učinkovitost cepiva je bila izračunana z uporabo za rotavirus negativnih bolnišničnih kontrolnih preiskovancev (pri računanju ocene za Tajvan se je združilo kontrolne za rotavirus negativne bolnišnične preiskovance in kontrolne bolnišnične preiskovance brez diareje).
English: Both components must be mixed together before your child receives the vaccine.
Slovenian: Preden bo vaš otrok prejel cepivo, je treba obe sestavini zmešati skupaj.
English: Rotavirus vaccine, live
Slovenian: Cepivo proti rotavirusom, živo
English: A. What you need to do before giving Rotarix
Slovenian: A. Kaj morate narediti pred dajanjem cepiva Rotarix 1.
English: Immune response in preterm infants
Slovenian: Imunski odziv pri nedonošenčkih
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)
Slovenian: EU/1/05/330/001- pakiranje po 1 (steklenička + peroralni aplikator + nastavek za prenos) EU/1/05/330/002 - pakiranje po 5 (steklenička + peroralni aplikator + nastavek za prenos) EU/1/05/330/003 - pakiranje po 10 (steklenička + peroralni aplikator + nastavek za prenos) EU/1/05/330/004 - pakiranje po 25 (steklenička + peroralni aplikator + nastavek za prenos)
English: Dulbecco's Modified Eagle Medium (DMEM)
Slovenian: Dulbekov spremenjeni nujni medij (DMEM - »Dulbecco's Modified Eagle Medium«) voda za injekcije
English: Human rotavirus RIX4414 strain (live, attenuated)*
Slovenian: Humani rotavirus, sev RIX4414 (živ, atenuiran)*
English: Human rotavirus RIX4414 strain (live, attenuated)
Slovenian: Humani rotavirus, sev RIX4414 (živ, atenuiran)
English: In a clinical study, 100 infants with HIV infection were administered Rotarix lyophilised formulation or placebo.
Slovenian: V klinični študiji je 100 dojenčkov, okuženih s HIV, dobilo cepivo Rotarix ali placebo.
English: The reconstituted vaccine will appear more turbid than the solvent alone.
Slovenian: Rekonstituirano cepivo je bolj motno kot sam vehikel.
English: Haematochezia
Slovenian: hematohezija
English: Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code: J07BH01 Protective efficacy of the lyophilised formulation
Slovenian: oznaka ATC: J07BH01 Učinkovitost zaščite liofilizirane oblike cepiva
English: Severe rotavirus gastroenteritis† (2nd year of life) Rotarix N=7,175 Placebo N=7,062
Slovenian: Hud rotavirusni gastroenteritis† (drugo leto življenja) Rotarix n = 7.175 Placebo n = 7.062
English: f) Twist the separated oral tube.
Slovenian: f) Zavrtite ločeno tubo.
English: In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given.
Slovenian: Med kliničnimi preskušanji je redko prihajalo do izpljuvanja ali regurgitacije cepiva.
English: For instructions for the preparation or reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede priprave ali rekonstitucije cepiva pred dajanjem glejte poglavje 6.6. 4.3 Kontraindikacije
English: In addition, efficacy against uncommon rotavirus genotypes G8P[4](severe gastro-enteritis) and G12P[6] (any gastro-enteritis) has been demonstrated.
Slovenian: Poleg tega so dokazali učinkovitost proti manj pogostima rotavirusnima genotipoma G8P[4] (hud gastroenteritis) in G12P[6] (gastroenteritis katerekoli jakosti).
English: • Then lift off the cap.
Slovenian: • Nato odstranite zaporko.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/330/009 - pack of 1 tube EU/1/05/330/010 - pack of 10 tubes EU/1/05/330/011 - pack of 50 tubes
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/330/009 - pakiranje z 1 tubo EU/1/05/330/010 - pakiranje z 10 tubami EU/1/05/330/011 - pakiranje s 50 tubami
English: If your child gets any of the side effects, talk to your doctor or pharmacist.
Slovenian: - Če pri vašem otroku opazite katerikoli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
English: Circulating rotavirus strains † Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale
Slovenian: Krožeči sevi rotavirusov † Hud rotavirusni gastroenteritis je bil definiran z oceno ≥ 11 na Vesikarijevi lestvici.
English: Withdraw the entire mixture back into the oral applicator
Slovenian: Celotno vsebino rekonstituiranega cepiva potegnite nazaj v peroralni aplikator.
English: Brazil
Slovenian: Brazilija
English: The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting.
Slovenian: Cepljenje s cepivom Rotarix je treba odložiti pri osebah, ki imajo drisko ali bruhajo.
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”).
Slovenian: Če se otroku, ki je dobil cepivo Rotarix, pojavijo hude bolečine v trebuhu, dolgotrajno bruhanje, kri v blatu, napihnjen trebuh in/ali močno zvišana telesna temperatura, se morate nemudoma posvetovati z zdravnikom ali drugim zdravstvenim osebjem (glejte tudi poglavje 4 »Možni neželeni učinki«).
English: C. Give the vaccine orally immediately after opening
Slovenian: C. Cepivo dajte peroralno takoj po odprtju tube 1.
English: Placebo
Slovenian: Placebo n
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.
Slovenian: Ker je imunski odziv, opažen po aplikaciji 2 odmerkov tekoče oblike cepiva Rotarix, primerljiv z imunskim odzivom po aplikaciji 2 odmerkov liofilizirane oblike cepiva Rotarix, lahko domnevamo, da je učinkovitost zaščite tekoče oblike enaka učinkovitosti zaščite liofilizirane oblike.