natgillin/translations-raw huggingface dataset:
If not used immediately, in-use storage should not be longer than 24 hours and at a temperature between 2-25°C.
čas shranjevanja med uporabo ne sme presegati 24 ur pri temperaturi od 2°C do 25 °C.
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Pogosti (≥ 1/100 do < 1/10) Občasni (≥ 1/1.000 do < 1/100) Redki (≥ 1/10.000 do < 1/1.000) Zelo redki (< 1/10.000)
Oral suspension 1 tube
peroralna suspenzija 1 tuba
This is so that the unused oral tubes can be used for the next vaccination.
To morate narediti zato, da lahko neporabljene tube uporabite za naslednje cepljenje.
Your child will receive two doses of the vaccine.
Otrok bo prejel dva odmerka cepiva.
No cases of intussusception were reported.
Opisan ni bil noben primer invaginacije.
All RVGE
Vsi RVGE
Do not hold the body of the oral tube, you may squeeze out some of the vaccine.
Ne držite telesa tube, saj lahko iz nje iztisnete nekaj cepiva.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2006
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. februar 2006
Schedule Studies conducted in
Študije izvedene v
• If the membrane has not been pierced return to section B and repeat steps 2, 3 and 4.
Kaj narediti, če membrana ni prebodena • Če membrana ni prebodena, se vrnite na točko B in ponovite korake 2,3 in 4.
Abdominal pain, flatulence
Občasni abdominalna bolečina, flatulenca
Similar studies in Armenia, Australia, Brazil, Canada, El Salvador and Zambia showed a reduction of 45 to 93% between 2 and 4 years after vaccine introduction.
Podobne študije v Armeniji, Avstraliji, Braziliji, Kanadi, El Salvadorju in Zambiji so pokazale zmanjšanja od 45 % do 93 % dve do štiri leta po uvedbi cepiva.
e) Hold the tab of the separated oral tube in one hand and the connecting bar in the other hand.
e) Držite dno ločene tube v eni roki in povezovalno ploščico v drugi.
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.
Za ločitev ene tube od ostalih, začnite na enem koncu: a) Primite dno ene od krajnih tub, da jo ločite od ostalih.
The vaccine is to be administered orally without mixing with any other vaccines or solutions.
Cepivo je treba aplicirati peroralno brez mešanja z drugimi cepivi ali raztopinami.
• Provide, on a 6-month basis, updates on the progress being made on the activities set out in the implementation plan for the development of a PCV-free vaccine, as agreed by CHMP on 15 September 2016: every June and December until the PCV-free Rotarix application.
• vsakih 6 mesecev predal posodobljene informacije o doseženem napredku pri dejavnostih, določenih v implementacijskem načrtu za razvoj cepiva brez PCV, kot je bilo dogovorjeno z odborom CHMP 15. septembra 2016: vsak junij in december, do oddaje vloge za cepivo brez PCV;
It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on longer periods of follow-up (see section 4.4).
Nepojasnjeno ostaja, ali cepiva proti rotavirusom vplivajo na celotno pogostnost invaginacije pri daljših obdobjih spremljanja (glejte poglavje 4.4).
High Income countries
Države z visokim prihodkom
Severity of gastro-enteritis (GE) was defined according to WHO criteria.
Resnost gastroenteritisa (GE) je bila definirana po kriterijih Svetovne zdravstvene organizacije.
Check that each individual oral tube is not damaged and is still sealed.
Preverite, da nobena posamezna tuba ni poškodovana in je še vedno zapečatena.
• There is a small spike inside the top of the cap - in the centre.
• V notranjosti vrha zaporke je majhna konica - v sredini.
• Give the vaccine straight away.
• Cepivo uporabite takoj.
C Check the tube has opened correctly 1.
C Preverite, da ste tubo pravilno odprli 1.
• he/she has any disease or is taking any medicine which reduces his/her resistance to infection or if his/her mother has taken during pregnancy any medicine that may weaken the immune system.
• ima otrok katerokoli bolezen ali jemlje katerokoli zdravilo, ki zmanjšuje njegovo odpornost na okužbe ali je njegova mati med nosečnostjo jemala katerokoli zdravilo, ki lahko oslabi imunski sistem.
- Pre-filled oral applicator: 3 years
- Napolnjen peroralni aplikator: 3 leta
Rotarix should not be used in children over 24 weeks of age.
Cepivo Rotarix se ne sme uporabljati pri otrocih, starejših od 24 tednov.
3, 5 months Finland, Italy 180
Finska, Italija 180
• There should be a hole at the top of the tube.
• Na vrhu tube mora biti luknjica.
• Check the tube has not been damaged nor is already open.
• Preverite, da tuba ni poškodovana ali že odprta.
• Very rare: hives (urticaria)
• zelo redki: koprivnica (urtikarija)
A clinical study in a limited number of asymptomatic or mildly symptomatic HIV positive infants showed no apparent safety problems (see section 4.8).
Klinična študija pri majhnem številu asimptomatskih ali blago simptomatskih HIV-pozitivnih dojenčkov ni pokazala očitnih težav z varnostjo (glejte poglavje 4.8).
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.
Neporabljene tube, ki so še vedno pritrjene na povezovalno ploščico, morate shraniti nazaj v hladilnik takoj po tem, ko ste eno tubo porabili.
• Keep the cap - you need this to pierce the membrane.
• Zaporko obdržite - potrebujete jo, da boste prebodli membrano.
• inflammation of the skin
• napihnjenost • vnetje kože
• Squeeze the liquid gently into the side of the child's mouth - towards the inside of their cheek.
• Nežno stisnite tekočino na stran otrokovih ust - proti notranjosti lica.
• It is ready to use - you do not need to mix it with anything.
• Cepivo je pripravljeno za uporabo - ni vam ga treba zmešati z ničemer.
Safety in infants with human immunodeficiency (HIV) infection
Varnost pri dojenčkih, okuženih s HIV (virusom humane imunske pomanjkljivosti)
Expiry date: DD/MM/YY
Rok uporabnosti: : DD/MM/YY
In order to address the presence of porcine circovirus type 1(PCV-1) in Rotarix, the MAH commits to:
Z namenom obravnavanja prisotnosti prašičjega cirkovirusa tipa 1 (PCV-1) v cepivu Rotarix, se imetnik DzP zavezuje, da bo:
• One oral tube delivers one dose of vaccine.
• Ena tuba vsebuje en odmerek cepiva.
Rotarix should under no circumstances be injected.
Cepiva Rotarix se v nobenem primeru ne sme injicirati.
Subjects with Severe Combined Immunodeficiency (SCID) disorder (see section 4.8).
Osebe s hudo kombinirano imunsko pomanjkljivostjo (SCID) (glejte poglavje 4.8).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine.
Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo prejeti tega cepiva.
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.
Poleg tega je devet študij vpliva na hospitalizacije zaradi driske zaradi vseh vzrokov, izvedenih v Afriki in Latinski Ameriki, pokazalo zmanjšanje od 14 % do 57 % dve do pet let po uvedbi cepiva.
The presence of a minor infection is not a contra-indication for immunisation.
Blage okužbe niso kontraindikacija za cepljenje.
Countries Period
Država Obdobje
Parents/guardians should be advised to promptly report such symptoms to their healthcare provider.
Staršem oz. skrbnikom je potrebno svetovati, da o takšnih simptomih nemudoma poročajo zdravniku.
Administer the entire content of the oral applicator orally (by administering the entire content of the oral applicator on the inside of the cheek)
Celotno vsebino peroralnega aplikatorja aplicirajte peroralno (tako, da aplicirate celotno vsebino peroralnega aplikatorja na notranjo stran lica).
It might be necessary to postpone the vaccination until recovery.
Cepljenje bo morda treba odložiti, dokler ne bo ozdravel.
(6) In subjects who did not receive the full course of vaccination, the effectiveness after one dose ranged from
(6) Med preiskovanci, ki niso prejeli celotnega zaporedja cepljenja, je bila učinkovitost po enem odmerku v razponu od
Data from observational safety studies performed in several countries indicate that rotavirus vaccines carry an increased risk of intussusception, mostly within 7 days of vaccination.
Invaginacija Podatki iz opazovalnih študij varnosti, opravljenih v več državah, kažejo, da cepiva proti rotavirusom spremlja povečano tveganje za invaginacijo, večinoma v 7 dneh po cepljenju.
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.
V skladu z dobro klinično prakso se je pred cepljenjem treba seznaniti z anamnezo, še posebej v povezavi z morebitnimi kontraindikacijami in opraviti klinični pregled.
D Give the vaccine
D Dajanje cepiva
If you notice anything abnormal, do not use the vaccine.
Če opazite karkoli nenormalnega, ne uporabite cepiva.
It is important that you follow the instructions of your doctor or nurse regarding return visits.
Pomembno je, da natančno upoštevate navodila zdravnika ali drugega zdravstvenega osebja glede ponovnega obiska zaradi cepljenja s tem cepivom.
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.
V teh državah so ugotovili do 6 dodatnih primerov na 100.000 dojenčkov v primerjavi z osnovno incidenco od 25 do 101 na 100.000 dojenčkov (mlajših od enega leta starosti) na leto.
• 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.
• najkasneje do leta 2020 oddal vlogo za spremembo dovoljenja za promet, da bo zagotovil cepivo brez PCV.
* Not statistically significant (p ≥0.05).
* Ni statistično značilno (p ≥ 0,05).
• This vaccine is given orally - straight from the tube.
• To cepivo se daje peroralno - neposredno iz tube.
The vaccine should be used immediately after opening.
Cepivo je treba uporabiti takoj po odprtju vsebnika.
The child should be seated in a reclining position.
Otroka morate namestiti v pokončen položaj.
Contacts of recent vaccinees should observe personal hygiene (e.g. wash their hands after changing child's nappies).
Osebe, ki so v stiku s pred kratkim cepljenim otrokom, morajo poskrbeti za ustrezno osebno higieno (npr. umivanje rok po menjavi plenic).
Rotarix is not intended for use in adults.
Cepivo Rotarix ni namenjeno za uporabo pri odraslih.
Contact a doctor/health care professional right away if your child experiences one of these symptoms.
Nemudoma se posvetujte z zdravnikom ali drugim zdravstvenim osebjem, če se pri vašem otroku pojavi kateri izmed teh simptomov.
Other medicines and Rotarix
Druga zdravila in cepivo Rotarix
Effectiveness after 2 doses in preventing RVGE leading to hospitalization
Učinkovitost po 2 odmerkih za preprečevanje RVGE, ki povzroči sprejem v bolnišnico
Do not inject!
Ne injicirajte!
Serious adverse events were observed in 5.1% of recipients of Rotarix as compared with 6.8% of placebo recipients.
Resne neželene učinke so opazili pri 5,1 % otrok, ki so dobili cepivo Rotarix, in pri 6,8 % tistih, ki so dobili placebo.
The vaccine is ready to use (no reconstitution or dilution is required).
Cepivo je že pripravljeno za uporabo (brez rekonstitucije ali nadaljnjega redčenja).
• if your child was born with a malformation of the gut that could lead to intussusception.
• če se je rodil z nepravilnostjo črevesja, ki bi lahko povzročila invaginacijo;
Rotarix with food and drink
Uporaba cepiva Rotarix skupaj s hrano in pijačo
Immune response
Imunski odziv
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.
Priložen je tudi nastavek za prenos, ki omogoča enostaven prenos vehikla v stekleničko s praškom in s tem pripravo mešanice dveh različnih sestavin cepiva.
§NOTE : Impact studies are meant to establish a temporal relationship but not a causal relationship between the disease and vaccination.
§OPOMBA: Namen študij vpliva je ugotoviti časovno povezanost med boleznijo in cepljenjem, ne vzročne povezanosti.
This product contains sucrose 9 mg and sorbitol 13.5 mg (see section 4.4).
Cepivo vsebuje 9 mg saharoze in 13,5 mg sorbitola (glejte poglavje 4.4).
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.
Uporaba cepiva Rotarix pri dojenčkih z znano imunsko pomanjkljivostjo ali sumom nanjo, vključno z in utero izpostavljenostjo imunosupresivnemu zdravljenju, mora temeljiti na natančni oceni možnih koristi in tveganj.
(7) NA: Not available.
(7) NP: ni podatka.
The first dose was administered from 6 weeks after birth.
Prvi odmerek so dobili po 6. tednu po rojstvu.
The safety profile presented below is based on data from clinical trials conducted with either the lyophilised or the liquid formulation of Rotarix.
Spodaj predstavljene varnostne značilnosti temeljijo na podatkih iz kliničnih preskušanj, opravljenih bodisi z liofilizirano ali tekočo obliko cepiva Rotarix.
- Squeezable tube fitted with a membrane and a tube cap: 3 years
- Tuba z membrano in pokrita z zaporko tube: 3 leta
There should be an interval of at least 4 weeks between doses.
Med obema odmerkoma morajo miniti vsaj 4 tedni.
Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy of Rotarix.
Ni pričakovati, da bi asimptomatske ali blago simptomatske okužbe s HIV vplivale na varnost ali učinkovitost cepiva Rotarix.
• if your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).
• če je predhodno imel invaginacijo črevesja (črevesno zaporo, pri kateri se en del črevesja uviha v drugega);
N % ≥ 20U/ml [95% CI]
% ≥ 20 e./ml [95 % IZ]
Rotarix is available in a pack of 50 tubes.
Cepivo Rotarix je na voljo v pakiranju po 50 tub.
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.
Poleg tega je v SmPC-ju imunosupresivnih zdravil, kot so adalimumab, infliksimab, priporočilo, da se preloži cepljenje z živimi cepivi pri dojenčkih, ki so bili in utero izpostavljeni tem zdravilom.
A clinical study performed in Latin America evaluated Rotarix in more than 20,000 subjects.
Klinična študija, izvedena v Latinski Ameriki, je cepivo Rotarix ovrednotila pri več kot 20.000 osebah.
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.
Z namenom, da se izboljša trenutno opozorilo o dajanju cepiva Rotarix dojenčkom z znano ali s sumom na imunsko pomanjkljivost, se priporoča posodobitev trenutnega opozorila.
Rotarix may be given according to the same vaccination course to infants who were born prematurely, provided that the pregnancy had lasted at least 27 weeks.
Pri nedonošenčkih se lahko cepivo Rotarix uporabi po enakem razporedu cepljenja, pod pogojem, da je nosečnost trajala vsaj 27 tednov.
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.
Klinična zaščita je bila ocenjena v kohorti po protokolu za učinkovitost, ki vključuje vse preiskovance iz kohorte po protokolu za varnost, vključene v zadevno obdobje spremljanja učinkovitosti.
Protective efficacy in Latin America
Učinkovitost zaščite v Latinski Ameriki
Position the child to give the vaccine • Seat the child leaning slightly backwards.
Namestite otroka za dajanje cepiva • Posedite otroka tako, da bo nagnjen rahlo nazaj.
The safety profile was similar between Rotarix and placebo recipients.
Varnostni profil je bil pri prejemnikih cepiva Rotarix in placeba podoben.
• You may need to squeeze the tube a few times to get all of the vaccine out - it is okay if a drop remains in the tip of the tube.
• Tubo boste morda morali nekajkrat stisniti, da boste iztisnili celotno cepivo - povsem v redu je, če kapljica ostane v konici tube.
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.
Oba odmerka cepiva mora prejeti, preden dopolni 24 tednov, najbolje pa je, da ju prejme že pred dopolnjenim 16. tednom starosti.
Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
Osebe z nekorigirano kongenitalno malformacijo gastrointestinalnega trakta, ki je lahko predispozicija za invaginacijo.
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.
V retrospektivni študiji podatkovne baze v Belgiji, izvedene pri otrocih, starih 5 let ali manj, je neposredni in posredni vpliv cepljenja s cepivom Rotarix na hospitalizacije, povezane z rotavirusi, dve leti po uvedbi cepiva segal od 64 % (95 % IZ: 49, 76) do 80 % (95 % IZ: 77, 83).
• blood in stools
• kri v blatu
If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.
Če ste na predvideni obisk pozabili, se posvetujte z zdravnikom.
• if your child has a severe infection with a high temperature.
• če ima hujšo okužbo s povišano telesno temperaturo.
Rotarix is a clear and colourless liquid.
Cepivo Rotarix je bistra in brezbarvna tekočina.
No increase in the incidence or severity of these events was seen with the second dose.
Po aplikaciji drugega odmerka se pojavnost ali resnost omenjenih učinkov ni povečala.
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).
Enako odmerjanje cepiva Rotarix lahko uporabimo pri nedonošenčkih, rojenih po vsaj 27 tednih gestacijske starosti (glejte poglavji 4.8 in 5.1).
What Rotarix is and what it is used for
Kaj je cepivo Rotarix in za kaj ga uporabljamo
This product contains sucrose 1,073 mg (see section 4.4).
Cepivo vsebuje 1.073 mg saharoze (glejte poglavje 4.4).
• Hold the side of tube
• Držite stranico tube.
To open the separated oral tube: d) Keep the separated oral tube held upright.
Odpiranje ločene tube: d) Ločeno tubo držite pokončno.
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).
Zdravstveno osebje mora, kot previdnostni ukrep, spremljati vse simptome, ki kažejo na invaginacijo (hude bolečine v trebuhu, dolgotrajno bruhanje, krvavo blato, napihnjenost trebuha in/ali močno zvišano telesno temperaturo), saj podatki iz opazovalnih varnostnih študij kažejo povečano tveganje za invaginacijo, večinoma v 7 dneh po cepljenju s cepivom proti rotavirusu (glejte poglavje 4.8).
Check the expiry date on the connecting bar. 2.
Preverite datum roka uporabnosti na povezovalni ploščici.
How Rotarix works:
Kako cepivo Rotarix deluje:
Press the cap down to pierce the membrane.
Pritisnite zaporko navzdol, da prebodete membrano.
• You may need to squeeze the oral tube a few times to get all of the vaccine out - it is okay if a drop stays in the oral tube.
• Tubo boste morda morali nekajkrat stisniti, da boste iztisnili celotno cepivo - povsem v redu je, če kapljica ostane v tubi.
The extent of protection that Rotarix might provide against other rotavirus strains that have not been circulating in clinical trials is currently unknown.
Obseg morebitne zaščite, dosežene s cepivom Rotarix, proti drugim rotavirusnim sevom, ki med kliničnimi preskušanji niso krožili, trenutno ni znan.
These antibodies protect against disease caused by these types of rotavirus.
Protitelesa ščitijo pred boleznijo, ki jo povzročajo ti serotipi rotavirusov.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Znaki alergijske reakcije lahko vključujejo srbeč kožni izpuščaj, zasoplost in otekanje obraza ali jezika;
If the reconstituted vaccine is to be stored temporarily before administration, replace the protective tip cap on the oral applicator.
Če rekonstituirano cepivo pred aplikacijo začasno shranite, na peroralni aplikator namestite zaščitni pokrovček.
• This vaccine is given orally straight from an individual tube.
• To cepivo se daje peroralno - neposredno iz posamezne tube.
51% (95% CI: 26;67, El Salvador) to 60% (95% CI: 37; 75, Brazil).
51 % (95 % IZ: 26;67 v El Salvadorju) do 60 % (95 % IZ: 37;75 v Braziliji).
In a total of four clinical trials, approximately 3,800 doses of Rotarix liquid formulation were administered to approximately 1,900 infants.
V skupaj štirih kliničnih preskušanjih so uporabili približno 3.800 odmerkov tekoče oblike cepiva Rotarix pri približno 1.900 dojenčkih.
The use of Rotarix should be based on official recommendations.
Cepivo Rotarix se sme uporabljati le v skladu z uradnimi priporočili.
Despite a low reporting rate of urticaria events (i.e. 0.013 cases per 100,000 doses distributed), some spontaneous cases suggested a possible association between Rotarix vaccination and urticaria.
0,013 primerov na 100.000 distribuiranih odmerkov) nekateri spontano poročani primeri kažejo možno povezavo med cepljenjem s cepivom Rotarix in urtikarijo.
The signs may include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever.
Med znaki so lahko hude bolečine v trebuhu, dolgotrajno bruhanje, kri v blatu, napihnjen trebuh in/ali močno zvišana telesna temperatura.
Protective efficacy in Africa
Učinkovitost zaščite v Afriki
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The following side effects may happen with this vaccine:
Pri tem cepivu lahko pride do naslednjih neželenih učinkov:
Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccinees have been observed without causing any clinical symptom.
Poročali so o prenašanju izločenega vakcinalnega virusa na seronegativne osebe, ki so bile v stiku s cepljeno osebo, pri čemer pa se klinični simptomi niso pojavili.
The immunologic mechanism by which Rotarix protects against rotavirus gastro-enteritis is not completely understood.
Imunološki mehanizem, s katerim cepivo Rotarix ščiti pred rotavirusnim gastroenteritisom, ni popolnoma pojasnjen.
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.
Podatki o varnosti, imunogenosti in učinkovitosti cepljenja v primerih, ko je za prvi odmerek uporabljeno cepivo Rotarix, za drugi odmerek pa drugo cepivo proti rotavirusom ali obratno, niso na voljo.
For subjects with a predisposition for intussusception, see section 4.3.
Za osebe z nagnjenostjo k invaginaciji glejte poglavje 4.3.
† Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale * Not statistically significant (p ≥ 0.05).
† Hud gastroenteritis je bil opredeljen kot ocena ≥ 11 na Vesikarijevi lestvici * Ni statistično značilno (p ≥ 0,05).