natgillin/translations-raw huggingface dataset:
If you forget to use RoActemra Since RoActemra is given by a doctor or nurse, it is unlikely that you will miss a dose.
Če ste pozabili uporabiti zdravilo RoActemra Ker vam bo zdravilo RoActemra dal zdravnik ali medicinska sestra, ni verjetno, da bi izpustili odmerek.
If you have any further questions on the use of RoActemra, then please ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila RoActemra, se posvetujte z zdravnikom ali s farmacevtom.
The most common side effects of RoActemra are upper respiratory tract infections, with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache.
Najpogostejši neželeni učinki zdravila RoActemra so okužbe zgornjih dihal z značilnimi simptomi, kot so kašelj, zamašen nos, izcedek iz nosu, vnetje žrela in glavobol.
Possible serious side effects include serious infections and allergic (hypersensitivity) reactions.
Med možnimi resnimi neželenimi učinki so resne okužbe in alergijske (preobčutljivostne) reakcije.
If you notice any of the following signs of:
Če opazite katerikoli znak za:
allergic reactions during or after infusion, tell your doctor immediately:
alergijske reakcije med infundiranjem ali po njem, morate to zdravniku povedati nemudoma:
- difficulty with breathing or light-headedness
- težave z dihanjem ali vrtoglavico,
- rash, itching, hives, swelling of the lips.
- izpuščaj, srbenje, koprivnico, otekanje ustnic.
infections, tell your doctor as soon as possible:
34 okužbe, morate to zdravniku povedati čim prej:
- fever and chills
- zvišano telesno temperaturo in mrzlico,
- mouth or skin blisters
- mehurje na ustih ali koži,
- stomach ache
- bolečine v trebuhu,
- persistent headaches.
- trdovraten glavobol.
The symptoms described above can be signs of the side effects listed below, all of which have been observed with RoActemra in clinical studies.
Zgoraj opisani simptomi so lahko znaki neželenih učinkov, navedenih spodaj, ki so jih vse zabeležili v kliničnih študijah zdravila RoActemra:
34 Side effects may occur with certain frequencies, which are defined as follows:
Neželeni učinki se lahko pojavijo z določenimi pogostnostmi, ki so opredeljene takole:
- uncommon: affects 1 to 10 users in 1,000
- občasni: pojavijo se pri 1 do 10 od 1. 000 bolnikov,
Very common side effects: upper respiratory tract infections like coughs and colds.
Zelo pogosti neželeni učinki: okužbe zgornjih dihal, npr. kašelj in prehlad.
Common side effects: lung infection (pneumonia), cold sores (oral herpes simplex), blisters, shingles (herpes zoster), skin infection sometimes with fever and chills, low white blood cell counts shown by blood tests (neutropenia, leucopenia), high cholesterol levels, headache, dizziness, high blood pressure, mouth ulceration, stomach pain, abnormal liver function tests (increased transaminases), rash and itching and eye infection (conjunctivitis).
Pogosti neželeni učinki: okužba pljuč (pljučnica), herpes (oralni herpes simpleks), mehurji, pasovec (herpes zoster), okužba kože, včasih z zvišano telesno temperaturo in mrzlico, majhno število belih krvnih celic, ki ga pokažejo preiskave krvi (nevtropenija, levkopenija), zvišana koncentracija holesterola, glavobol, omotica, visok krvni tlak, razjeda v ustih, bolečine v trebuhu, nenormalni testi delovanja jeter (zvišanje transaminaz), izpuščaj in srbenje ter okužba oči (konjunktivitis).
Uncommon side effects: diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain), red swollen (inflamed) areas in the mouth, high blood fat (triglycerides) and serious allergic (hypersensitivity) reactions.
Občasni neželeni učinki: divertikulitis (zvišana telesna temperatura, slabost, driska, zaprtje, bolečine v trebuhu), rdeči, otekli (vneti) predeli v ustih, zvišane maščobe v krvi (trigliceridi) in resne alergijske (preobčutljivostne) reakcije.
HOW TO STORE ROACTEMRA
SHRANJEVANJE ZDRAVILA ROACTEMRA
Store in a refrigerator (2°C–8°C).
Shranjujte v hladilniku (2 °C – 8 °C).
- The active substance is tocilizumab.
- Zdravilna učinkovina je tocilizumab.
Each 4 ml vial contains 80 mg tocilizumab (20 mg/ml).
Ena 4- ml viala vsebuje 80 mg tocilizumaba (20 mg/ ml).
Each 10 ml vial contains 200 mg tocilizumab (20 mg/ml).
Ena 10- ml viala vsebuje 200 mg tocilizumaba (20 mg/ ml).
Each 20 ml vial contains 400 mg tocilizumab (20 mg/ml).
Ena 20- ml viala vsebuje 400 mg tocilizumaba (20 mg/ ml).
- The other ingredients are sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium
- Pomožne snovi so saharoza, polisorbat 80, natrijev hidrogenfosfat dodekahidrat, natrijev
dihydrogen phosphate dihydrate and water for injections.
dihidrogenfosfat dihidrat in voda za injekcije.
What RoActemra looks like and contents of the pack RoActemra is a concentrate for solution for infusion.
Izgled zdravila RoActemra in vsebina pakiranja
RoActemra is supplied as vials containing 4 ml, 10 ml and 20 ml concentrate for solution for infusion.
35 Zdravilo RoActemra je na voljo v vialah po 4, 10 ali 20 ml koncentrata za raztopino za infundiranje.
35 Manufacturer Roche Pharma AG Emil-Barell-Str.
Izdelovalec Roche Pharma AG Emil- Barell- Str.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http://www.emea.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/ml (0.9%) solution for injection from a 100 ml infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions.
V aseptičnih pogojih iz 100- ml vrečke za infundiranje izvlecite toliko sterilne, apirogene 0, 9 -% (9 mg/ ml) raztopine natrijevega klorida za injiciranje, kot je potrebni volumen koncentrata zdravila RoActemra za bolnikov odmerek.
The required amount of RoActemra concentrate (0.4 ml/kg) should be withdrawn from the vial and placed in the 100 ml infusion bag.
Potrebno količino koncentrata zdravila RoActemra (0, 4 ml/ kg) morate izvleči iz viale in dati v 100- ml vrečko za infundiranje.
37
37 Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Rotarix is an oral vaccine.
Rotarix je peroralno cepivo (cepivo, ki ga bolnik zaužije skozi usta).
It is presented as a powder and solvent which are mixed to make up an oral suspension.
Na voljo je v dveh oblikah: • kot prašek in vehikel, ki se v peroralnem aplikatorju zmešata v peroralno suspenzijo; • kot peroralna suspenzija v predhodno napolnjenem peroralnem aplikatorju ali epruveti.
It contains a live attenuated (weakened) form of the human rotavirus (RIX4414 strain).
Cepivo Rotarix vsebuje živo atenuirano (oslabljeno) obliko humanega rotavirusa (sev RIX4414).
Rotarix is used in babies from six weeks of age as a vaccine to prevent gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Cepivo Rotarix se uporablja pri dojenčkih, starejših od šest tednov, za preprečevanje gastroenteritisa (driske in bruhanja), ki ga povzroča okužba z rotavirusi.
Rotarix is given according to official recommendations.
Cepivo Rotarix se daje v skladu z uradnimi priporočili.
Rotarix is given as two doses, given at least four weeks apart.
Cepivo Rotarix se daje z dvema odmerkoma, med katerima mora biti najmanj štiritedenski presledek.
It is better if the full course (both doses) is given before the child is aged 16 weeks, and in any case, it should have been given by the time the child is 24 weeks old.
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.
The powder and solvent are mixed just before administration, and the resulting suspension is given directly into the mouth of the baby using the oral syringe provided.
Če za cepljenje uporabljamo peroralno suspenzijo, je treba vsebino predhodno napolnjenega peroralnega aplikatorja ali epruvete dati v dojenčkova usta.
Rotarix can be given at the same time as other vaccinations.
Cepivo Rotarix se lahko daje sočasno z drugimi cepivi.
Rotarix contains small amounts of rotavirus, a virus that causes gastroenteritis.
Cepivo Rotarix vsebuje majhno količino rotavirusa, virusa, ki povzroča gastroenteritis.
The virus is alive, but it has been weakened so that it does not cause the disease, and this makes it suitable to use in a vaccine.
Virus je živ, vendar oslabljen, tako da ne povzroči bolezni, zato je primeren za uporabo v cepivu.
When a child is given the vaccine, the immune system (the system that fights diseases) recognises the weakened virus as ‘ foreign’ and makes antibodies against it (an antibody is a special protein that can neutralise or destroy an antigen, such as an infectious agent or virus).
Protitelesa so posebne beljakovine, ki lahko nevtralizirajo ali uničijo antigene, kot so na primer infekcijski agensi ali virusi.
Between 78 and 95% of babies receiving Rotarix make antibodies against rotavirus after vaccination.
Med 78 in 95% dojenčkov je po cepljenju s cepivom Rotarix tvorilo protitelesa proti rotavirusom.
The effects of Rotarix were first tested in experimental models before being studied in humans.
Učinki cepiva Rotarix so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Overall, the clinical studies of Rotarix in humans involved over 72,000 infants and took place in various countries worldwide.
Klinične študije cepiva Rotarix pri ljudeh so skupaj zajele prek 72. 000 dojenčkov in so potekale po različnih državah na vseh koncih sveta.
In all studies, the vaccine was compared with a placebo (a dummy vaccine).
V vseh študijah so cepivo primerjali s placebom (cepivom brez zdravilne učinkovine).
The main study looked at the effectiveness and safety of Rotarix, and it involved over 63,000 infants.
V glavni študiji so preučevali učinkovitost in varnost cepiva Rotarix, v njej pa je sodelovalo prek 63. 000 dojenčkov.
The study was very large because it was designed to see if the vaccine caused a very rare, serious side effect, intussusception, a condition in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage.
Študija je bila široko zasnovana zato, da bi lahko ugotovili, ali cepivo povzroči zelo redek in resen neželen učinek, imenovan invaginacija, pri katerem se en del črevesja uviha v drugega, kar vodi do zapore črevesja.
Effectiveness was measured by looking at how many 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Učinkovitost cepiva so merili na podlagi števila otrok, ki so v obdobju po cepljenju in pred dopolnjenim enim letom starosti razvili hud rotavirusni gastroenteritis.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged children developed severe rotavirus gastroenteritis in the months after they had been vaccinated (and before they reached one year of age).
V štirih dodatnih študijah, v katerih je sodelovalo več kot 3000 dojenčkov, so ugotavljali, ali sta obe obliki cepiva enako varni in učinkoviti pri stimulaciji tvorbe protiteles proti rotavirusom.
12 infants vaccinated with Rotarix developed severe rotavirus gastroenteritis compared to 77 cases among those who received placebo.
V glavni študiji je bilo število primerov hudega rotavirusnega gastroenteritisa po cepljenju s cepivom Rotarix manjše: hud rotavirusni gastroenteritis se je razvil pri 0, 1% dojenčkov, cepljenih s cepivom Rotarix, pri katerih so ugotavljali učinkovitost cepiva (pri 12 od skupno 9000 dojenčkov) v primerjavi z 0, 9% dojenčkov, ki so prejeli placebo (pri 77 od skupno 9000 dojenčkov).
In the main study, in which about 31,500 children received Rotarix and 31,500 received placebo, nine children developed intussusception following vaccination with Rotarix, compared to 16 who developed the disease after receiving a placebo vaccine.
V glavni študiji, v kateri je 31. 500 dojenčkov prejelo cepivo Rotarix, 31. 500 pa placebo, se je po cepljenju s cepivom Rotarix pri devetih dojenčkih razvila invaginacija v primerjavi s 16 otroki, ki so za invaginacijo zboleli po cepljenju s placebom.
This shows that there is no increased risk of intussusception with Rotarix.
Iz tega je razvidno, da tveganje za invaginacijo zaradi cepiva Rotarix ni povečano.
The most common side effects (seen in more than 1 patient in 10) are irritability and loss of appetite.
Najpogostejša neželena učinka (opažena pri več kot 1 bolniku od 10) sta razdražljivost in izguba teka.
For the full list of all side effects reported with Rotarix, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Rotarix, glejte navodilo za uporabo.
Rotarix should not be used in children who may be hypersensitive (allergic) to any of the ingredients of the vaccine, or who have shown signs of allergy after having received a previous dose of rotavirus vaccine.
Cepiva Rotarix ne smejo prejeti dojenčki, ki utegnejo biti preobčutljivi za (alergični na) katero koli sestavino cepiva ali pri katerih so se pokazali znaki alergije po prejetem predhodnem odmerku cepiv proti rotavirusom.
It should not be given to children who have had intussusception in the past, or who have problems with their bowel that could predispose them to the disease.
Cepiva ne smejo prejeti dojenčki, ki so imeli invaginacijo v preteklosti ali ki imajo take težave s črevesjem, ki so lahko predispozicija za to bolezen.
It should also not be given to children whose immune system is weakened.
Za celoten seznam omejitev glejte navodilo za uporabo.
For the full list of restrictions, see the Package Leaflet.
Cepivo Rotarix se pod nobenim pogojem ne sme injicirati.
As for all vaccines, if Rotarix is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Tako kot pri vseh cepivih obstaja tudi pri cepivu Rotarix tveganje za razvoj apneje (kratkih premorov pri dihanju), če se daje mnogo prezgodaj rojenim dojenčkom.
Their breathing should be monitored for up to three days after vaccination.
Njihovo dihanje je treba nadzorovati do tri dni po dajanju cepiva, zlasti pa po prvem cepljenju.
The Committee for Medicinal Products for Human Use (CHMP) decided that Rotarix’ s benefits are greater than its risks for the vaccination of infants from the age of six weeks for the prevention of gastroenteritis due to rotavirus infection.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi cepiva Rotarix pri cepljenju dojenčkov, starejših od šest tednov, za preprečevanje gastroenteritisa, ki ga povzroča okužba z rotavirusom, večje od z njim povezanih tveganj.
The Committee recommended that Rotarix be given marketing authorisation.
Odbor je priporočil, da se za cepivo Rotarix odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Rotarix to GlaxoSmithKline Biologicals s. a. on 21 February 2006.
Evropska komisija je dovoljenje za promet s cepivom Rotarix, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s. a. dne 21. februarja 2006.
The full EPAR for Rotarix can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za cepivo Rotarix je na voljo tukaj.
This summary was last updated in 12-2007.
Povzetek je bil nazadnje posodobljen 09- 2008.
not less than 106.0 CCID50
ne manj kot 106, 0 CCID50
5 glass containers + 5 oral applicators + 5 transfer adapters
5 steklenih vsebnikov + 5 peroralnih aplikatorjev + 5 nastavkov za prenos
Powder and solvent for oral suspension
Prašek in vehikel za
Oral use
Peroralna
powder: glass container; solvent: oral applicator (glass)
prašek: stekleni vsebnik;
10 glass containers + 10 oral applicators + 10 transfer adapters
10 steklenih vsebnikov + 10 peroralnih aplikatorjev +
25 glass containers + 25 oral applicators + 25 transfer adapters
25 steklenih vsebnikov + 25 peroralnih aplikatorjev +
not less than 106.0 CCID50
ne manj kot
Prefilled oral applicator (glass)
Napolnjeni peroralni
Squeezable tube (polyethylene)
Stisljiva tuba
After reconstitution, 1 dose (1ml) contains:
Po rekonstituciji 1 odmerek (1 ml) vsebuje:
Human rotavirus RIX4414 strain (live, attenuated)*
ne manj kot 106. 0 CCID50 Humani rotavirus, sev RIX4414 (živ, atenuiran) *
*Produced on Vero cells
* Pridobljen na Vero celicah
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).
Rotarix is indicated for the active immunisation of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection (see section 4.2).
Uporabljamo ga za preprečevanje rotavirusnega gastroenteritisa (glejte poglavje 4. 2).
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of types G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8] (see sections 4.4 and 5.1).
V kliničnih preskušanjih so dokazali učinkovitost proti gastroenteritisu, ki ga povzročajo rotavirusi serotipov G1P[ 8], G2P[ 4], G3P[ 8], G4P[ 8] in G9P[ 8] (glejte poglavji 4. 4 in 5. 1).
The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks.
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.
In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given.
V takšnih primerih niso aplicirali nadomestnega odmerka.
It is recommended that infants who receive a first dose of Rotarix complete the 2-dose regimen with Rotarix.
Priporočamo, da otroci, ki so prejeli prvi odmerek cepiva Rotarix prejmejo tudi drugi odmerek cepiva Rotarix, in da se tako začeto cepljenje zaključi z istim cepivom.
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
2 Method of administration
2 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.
Previous history of intussusception.
Invaginacija v anamnezi.
Infants who have known or suspected immunodeficiency.
Otroci z imunsko pomanjkljivostjo ali sumom nanjo.
However, in the absence of sufficient data, administration of Rotarix to asymptomatic HIV subjects is not recommended.
Asimptomatska okužba z virusom HIV domnevno sicer ne vpliva na varnost in učinkovitost cepiva Rotarix, vendar pa, zaradi nezadostnih podatkov, pri osebah z asimptomatsko okužbo z virusom HIV uporabe cepiva Rotarix ne priporočamo.
Viral antigen particles detected by ELISA were found in 50% of stools after the first dose and 4% of stools after the second dose.
Po aplikaciji prvega odmerka cepiva so s testom ELISA odkrili virusne antigene v 50% vzorcev blata, po aplikaciji drugega odmerka cepiva pa v 4% vzorcev blata.
When these stools were tested for the presence of live vaccine strain, only 17% were positive.
Ko so te vzorce blata testirali na prisotnost živega vakcinalnega seva virusa, je bilo pozitivnih le 17% vzorcev.
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.
Pri otrocih, ki so v tesnem stiku z osebami z imunsko pomanjkljivostjo, npr. osebami z rakavimi obolenji, s kakor koli drugače oslabljenim imunskim sistemom ali osebami, ki se zdravijo z imunosupresivnimi zdravili, je potrebna previdnost pri cepljenju s cepivom Rotarix.
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).
Limited data in 140 premature children indicate that Rotarix can be given to premature children, however a lower immune response may be observed and the level of clinical protection remains unknown.
Stopnja klinične zaščite ni znana.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
3 Pri aplikaciji odmerkov primarne imunizacije veliko prezgodaj rojenim nedonošenčkom (rojenim pred ali v 28. tednu nosečnosti), še posebno tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati možnost pojava apneje in potrebo po 48 do 72 urnem spremljanju pljučnega delovanja.
3 As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Ker je korist cepljenja v tej skupini otrok velika, cepljenja ne bi smeli odložiti ali ga izpustiti.
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of types G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8].
V kliničnih preskušanjih so dokazali učinkovitost proti gastroenteritisu, ki ga povzročajo rotavirusi serotipov G1P[ 8], G2P[ 4], G3P[ 8], G4P[ 8] in G9P[ 8].
The extent of protection that Rotarix might provide against other serotypes is unknown.
Obseg morebitne zaščite, dosežene s cepivom Rotarix, proti drugim serotipom ni znan.
Clinical studies from which efficacy data were derived were conducted in Europe and Central and South America (see section 5.1).
Klinične študije na katerih temeljijo podatki o učinkovitosti so bile izvedene v Evropi in Centralni ter Južni Ameriki (glejte poglavje 5. 1).
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.
Rotarix can be given concomitantly with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/ Hib)]: diphtheria-tetanus-whole cell pertussis vaccine (DTPw), diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine.
Cepivo Rotarix se lahko daje sočasno s katerim koli od naslednjih monovalentnih ali kombiniranih cepiv [vključno s šestvalentnimi cepivi (DTPa- HBV- IPV/ Hib)]: cepivom proti davici, tetanusu in oslovskemu kašlju – celotna celica (DTPw), cepivom proti davici, tetanusu in oslovskemu kašlju – acelularno (DTPa), cepivom proti hemofilusu influence tipa b (Hib), inaktiviranim cepivom proti otroški ohromelosti (IPV), cepivom proti hepatitisu B (HBV), konjugiranim cepivom proti pnevmokokom in konjugiranim cepivom proti meningokokom serološke skupine C.
Clinical studies demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected.
S kliničnimi študijami so dokazali, da se imunski odziv in varnostni profil apliciranih cepiv ne spremeni.
Concominant administration of Rotarix and oral polio vaccine (OPV) does not affect the immune response to the polio antigens.
Pri sočasni aplikaciji cepiva Rotarix in peroralnega cepiva proti otroški ohromelosti (OPV) se imunski odziv na polio antigene ne spremeni.