FrancophonIA/ELRC3.0 huggingface dataset:
English: One chart-confirmed case was recorded among infants vaccinated with RotaTeq compared with one chart-confirmed case among concurrent DTaP controls (relative risk = 0.7, 95 % CI: 0.01-55.56).
Slovenian: Pri dojenčkih, cepljenih s cepivom RotaTeq, so na podlagi pregleda kartotek zabeležili en primer, v primerjavi z enim primerom v pripadajoči kontrolni skupini dojenčkov, cepljenih s cepivom DTaP (relativno tveganje = 0,7; 95-odstotni IZ: 0,01-55,56).
English: See section 6.6 for administration instructions.
Slovenian: Za navodila za uporabo glejte poglavje 6.6.
English: Based upon combined data from REST and the FES, the reduction up to 3 years post-vaccination in the rate of hospitalisations and emergency department visits for RV gastroenteritis was 94.4 % (95 % CI: 91.6, 96.2) for genotypes G1-G4, 95.5 % (95 % CI: 92.8, 97.2) for genotype G1, 81.9 % (95 % CI: 16.1, 98.0) for genotype G2, 89.0 % (95 % CI: 53.3, 98.7) for genotype G3, 83.4 % (95 % CI: 51.2, 95.8) for genotype G4, and 94.2 % (95 % CI: 62.2, 99.9) for genotype G9.
Slovenian: Na podlagi kombiniranih podatkov iz REST in FES je bilo zmanjšanje deleža hospitalizacij in obiskov nujne zdravniške pomoči zaradi RV gastroenteritisa v obdobju 3 let po cepljenju 94,4 % (95-odstotni IZ: 91,6; 96,2) za genotipe G1-G4, 95,5 % (95-odstotni IZ: 92,8; 97,2) za genotip G1, 81,9 % (95-odstotni IZ: 16,1; 98,0) za genotip G2, 89,0 % (95-odstotni IZ: 53,3; 98,7) za genotip G3, 83,4 % (95-odstotni IZ: 51,2; 95,8) za genotip G4 in 94,2 % (95-odstotni IZ: 62,2; 99,9) za genotip G9.
English: As with other vaccines, RotaTeq may not completely protect all children who are vaccinated even after all three doses have been given.
Slovenian: Kot velja za vsa cepiva, tudi cepivo RotaTeq morda ne bo popolnoma zaščitilo vseh cepljenih otrok, tudi po prejemu vseh treh odmerkov.
English: A doctor or nurse will administer the recommended doses of RotaTeq to your child.
Slovenian: Zdravnik ali medicinska sestra bo vašemu otroku dal-a priporočene odmerke cepiva RotaTeq.
English: In general, the adverse event profile reported with overdose was comparable to that observed with recommended doses of RotaTeq.
Slovenian: Na splošno je bil profil neželenih dogodkov pri prevelikem odmerjanju podoben kot med uporabo priporočenih odmerkov cepiva RotaTeq.
English: - your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).
Slovenian: - če je kdaj imel invaginacijo (zaprtje črevesa, pri katerem se en del črevesa vrine v drugi del črevesa).
English: Oral Solution Pale yellow clear liquid that may have a pink tint
Slovenian: peroralna raztopina bledorumena bistra tekočina, ki ima lahko rožnat odtenek
English: During year 3, there were no health care contacts for RV gastroenteritis in the vaccine group (n=3,112) and one (non-typeable) in the placebo group (n=3,126).
Slovenian: tretjem letu zaradi RV gastroenteritisa iz skupine, ki je prejela cepivo (n = 3.112), ni zdravnika obiskal nihče, v skupini, ki je prejela placebo (n = 3.126) pa je bil en (ne-tipiziran) obisk zdravnika.
English: Reduction in incidence of RV gastroenteritis through one full season post-vaccination (RotaTeq n=2,834) (% [95 % CI]) Efficacy against any severity by rotavirus genotype
Slovenian: Zmanjšanje pojavnosti RV gastroenteritisa med eno celotno sezono po cepljenju (RotaTeq n = 2.834) (% [95-odstotni IZ]) Učinkovitost proti bolezni katere koli intenzitete glede na genotip rotavirusa
English: Case-control study (US)
Slovenian: Študija primerov in kontrol (ZDA)
English: * human-bovine rotavirus reassortants (live), produced in Vero cells.
Slovenian: * reasortirani humano-bovini rotavirusi (živi), pridobljeni na celicah Vero infektivnih enot
English: See also section 3.
Slovenian: Glejte tudi poglavje 3.
English: 402 cases 2,559 controls* Aged <8 years Received 3 doses
Slovenian: 402 primerov 2.559 kontrol* starih < 8 let prejeti 3 odmerki hospitalizacija in obiski nujne medicinske pomoči zaradi RVGE
English: Adverse reactions following administration of RotaTeq in clinical trials and adverse events reported post-marketing (in italics)
Slovenian: Neželeni učinki po uporabi cepiva RotaTeq v kliničnih preskušanjih in neželeni dogodki, o katerih so poročali v obdobju trženja (poševna pisava)
English: RotaTeq is intended for use in infants only.
Slovenian: Cepivo RotaTeq je namenjeno samo za uporabo pri dojenčkih.
English: The first dose may be administered from the age of 6 weeks and no later than the age of 12 weeks.
Slovenian: Otrok lahko prvi odmerek prejme od 6 tednov starosti dalje, vendar pa najkasneje pri starosti 12 tednov.
English: As no data exist regarding the interchangeability of RotaTeq with another rotavirus vaccine, it is recommended that infants who receive RotaTeq for the first immunisation against rotavirus should receive this same vaccine for the subsequent doses.
Slovenian: Ker podatkov o zamenljivosti cepiva RotaTeq z drugimi cepivi proti rotavirusom ni na voljo, priporočamo, da otroci, ki so pri cepljenju s prvim odmerkom prejeli cepivo RotaTeq, prejmejo tudi naslednje odmerke istega cepiva.
English: RotaTeq is available in pack size of 1, 10 dosing tubes.
Slovenian: Cepivo RotaTeq je na voljo v pakiranjih po 1 ali 10 odmernih tub.
English: The other ingredients in RotaTeq are: sucrose, sodium citrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide, polysorbate 80, culture media (containing inorganic salts, amino acids and vitamins), and purified water.
Slovenian: Pomožne snovi cepiva RotaTeq so: saharoza, natrijev citrat, natrijev dihidrogenfosfat monohidrat, natrijev hidroksid, polisorbat 80, gojišče (ki vsebuje anorganske soli, aminokisline in vitamine) in prečiščena voda.
English: What RotaTeq is and what it is used for What you need to know before your child receives RotaTeq How to use RotaTeq
Slovenian: Kaj je cepivo RotaTeq in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok prejel cepivo RotaTeq Kako uporabljati cepivo RotaTeq Možni neželeni učinki
English: c. Description of selected adverse reactions
Slovenian: c. Opis posameznih neželenih učinkov
English: The level of protection provided by RotaTeq is based on the completion of all 3 doses.
Slovenian: Osnova za dosego stopnje zaščite, ki jo zagotavlja cepivo RotaTeq, je prejem vseh 3 odmerkov cepiva.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite kateri koli neželeni učinek, ki ni omenjen v tem navodilu.
English: Concomitant administration of RotaTeq and oral poliomyelitis vaccine (OPV) did not affect the immune response to the poliovirus antigens.
Slovenian: Sočasno dajanje cepiva RotaTeq in peroralnega cepiva proti otroški ohromelosti (oral poliolyelitis vaccine - OPV) ni vplivalo na imunski odziv na antigene poliovirusa.
English: Co-administration of RotaTeq with a group C meningococcal conjugate vaccine (MenCC, the vaccine studied was a tetanus toxoid conjugate) at 3 and 5 months of age (and mostly at the same time as DTaP-IPV-Hib vaccine), followed by a third dose of RotaTeq at approximately 6 months of age, demonstrated that the immune responses to RotaTeq and MenCC were unaffected.
Slovenian: Pri sočasni uporabi cepiva RotaTeq s konjugiranim cepivom proti meningokoku skupine C (MenCC, preučevali so konjugirano cepivo s toksoidom tetanusa) pri 3 in 5 mesecih starosti (in večinoma istočasno kot cepivo DTaP-IPV-Hib) in nato še tretjem odmerku cepiva RotaTeq pri približno 6 mesecih starosti, se je pokazalo, da se imunski odziv na cepivo RotaTeq in MenCC ni spremenil.
English: d. Other special populations Apnoea in very premature infants (born ≤28 weeks of gestation) (see section 4.4)
Slovenian: Apneja pri veliko prezgodaj rojenih nedonošenčkih (rojenih v 28. tednu nosečnosti ali prej) (glejte poglavje 4.4).
English: - has not been gaining weight and growing as expected.
Slovenian: - če sta otrokovo pridobivanje na telesni masi in njegova rast počasnejša, kot je pričakovano.
English: Hypersensitivity after previous administration of rotavirus vaccines.
Slovenian: Preobčutljivost po predhodnem dajanju cepiv proti rotavirusom.
English: No clinical data are available on the use of RotaTeq for post-exposure prophylaxis.
Slovenian: Kliničnih podatkov o uporabi cepiva RotaTeq za postekspozicijsko profilakso ni na voljo.
English: In a combined post-hoc analysis of REST and another phase III study, the vaccine efficacy against G1, G2-, G3- and G4-serotype RVG cases (any severity) was 61.5 % [95 % CI: 14.2; 84.2] among infants who were >26 to ≤32 weeks of age at dose 3.
Slovenian: V združeni post-hoc analizi študije REST in še ene študije faze III je bila učinkovitost cepiva proti RV gastroenteritisu (katere koli intenzitete), povzročenem s serotipi G1, G2, G3 in G4, 61,5 % [95-odstotni IZ: 14,2; 84,2] pri dojenčkih, ki so bili ob prejemu 3. odmerka stari > 26 do ≤ 32 tednov.
English: Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty.
Slovenian: Odmerek aplicirajte tako, da nežno iztisnete tekočino v otrokova usta v smeri proti notranji strani lica, dokler odmerna tuba ni prazna (v konici tube lahko ostane kapljica raztopine).
English: Danmark MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
Slovenian: MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
English: It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on longer periods of follow up (see section 4.4).
Slovenian: Iz daljšega obdobja spremljanja pojavnosti še vedno ni jasno, ali cepiva proti rotavirusom vplivajo na celotno pojavnost invaginacije (glejte poglavje 4.4).
English: • Common (may affect up to 1 in 10 infants): infections of the upper respiratory system
Slovenian: • pogosti (pojavijo se lahko pri največ 1 od 10 dojenčkov): okužbe zgornjih dihal
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neuporabljeno cepivo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: • Very common (may affect more than 1 in 10 infants): fever, diarrhoea, vomiting
Slovenian: • zelo pogosti (pojavijo se lahko pri več kot 1 od 10 dojenčkov): zvišana telesna temperatura, driska, bruhanje
English: The reduction in incidence of RV gastroenteritis caused by genotypes G1-G4 during the second rotavirus season after vaccination was 88.0 % [95 % CI 49.4, 98.7] for severe disease and 62.6 % [95 % CI 44.3, 75.4] for disease of any severity.
Slovenian: Zmanjšanje pojavnosti RV gastroenteritisa, povzročenega z genotipi G1-G4 med drugo rotavirusno sezono po cepljenju je bilo 88,0 % [95-odstotni IZ, 49,4; 98,7] za hudo obliko bolezni in 62,6 % [95-odstotni IZ, 44,3; 75,4] za bolezen katere koli intenzitete.
English: There have been reports of administration of higher than recommended doses of RotaTeq.
Slovenian: Poročali so o primerih uporabe večjih odmerkov cepiva RotaTeq od priporočenih.
English: When RotaTeq is given to your child for the first dose, it is recommended that your child also receives RotaTeq (and not another rotavirus vaccine) to complete the vaccination course.
Slovenian: Če vaš otrok kot prvi odmerek dobi cepivo RotaTeq, priporočamo, da cepivo RotaTeq (in ne drugo cepivo proti rotavirusom) dobi tudi za ostale odmerke.
English: However, in the absence of sufficient data, administration of RotaTeq to asymptomatic HIV-infected infants is not recommended.
Slovenian: Vendar pa zaradi pomanjkanja ustreznih podatkov uporabe cepiva RotaTeq pri dojenčkih z asimptomatsko okužbo s HIV ne priporočamo.
English: From birth to 6 weeks RotaTeq is not indicated in this subset of paediatric population.
Slovenian: Od rojstva do 6 tednov V tej podskupini pediatrične populacije cepivo RotaTeq ni indicirano.
English: b. Tabulated summary of adverse reactions
Slovenian: b. Tabelarični pregled neželenih učinkov
English: No further doses are recommended after completion of the 3-dose vaccination course (see sections 4.4 and 5.1 regarding available information on persistence of protection).
Slovenian: Po cepljenju s tremi odmerki ne priporočamo nobenih nadaljnjih odmerkov (za podatke o trajanju zaščite glejte poglavji 4.4 in 5.1).
English: Severe* disease (G1-G4)
Slovenian: Huda* bolezen (G1-G4)
English: This vaccine is contained in a single-dose tube and is a pale yellow clear liquid that may have a pink tint.
Slovenian: Cepivo je bledorumena bistra tekočina, ki ima lahko rožnat odtenek.
English: There are no restrictions on taking food or liquid, including breast milk, either before or after vaccination with RotaTeq.
Slovenian: Otrok lahko pred in po cepljenju s cepivom RotaTeq brez omejitev uživa hrano ali pijačo, vključno z materinim mlekom.
English: The efficacy of RotaTeq was comparable between this subset of infants and infants born at term.
Slovenian: Učinkovitost cepiva RotaTeq je bila v tej skupini otrok primerljiva s tistimi, rojenimi na rok.
English: Co-administration of RotaTeq with vaccines containing one or more of the following antigens at approximately 2, 4 and 6 months of age demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected: - Diphtheria-tetanus-acellular pertussis vaccine (DTaP) - Haemophilus influenzae type b vaccine (Hib) - Inactivated poliomyelitis vaccine (IPV) - Hepatitis B vaccine (HBV) - Pneumococcal conjugate vaccine (PCV)
Slovenian: Pri sočasni uporabi cepiva RotaTeq s cepivi, ki vsebujejo enega ali več spodaj naštetih antigenov, pri približno 2, 4 in 6 mesecih starosti, se je pokazalo, da se imunski odziv in varnostni profil prejetih cepiv nista spremenila: - cepivo proti davici, tetanusu in oslovskem kašlju (DTaP) - cepivo proti Haemophilusu influenzae tipa b (Hib) - inaktivirano cepivo proti otroški ohromelosti (IPV) - cepivo proti hepatitisu B (HBV) - konjugirano cepivo proti pnevmokokom (PCV).
English: 2 ml oral solution in a tube pack size of 1 tube pack size of 10 tubes
Slovenian: 2 ml peroralne raztopine v tubi velikost pakiranja: 1 tuba velikost pakiranja: 10 tub
English: RotaTeq should be administered with caution to individuals with close contacts who are immunodeficient (e.g., individuals with malignancies or who are otherwise immunocompromised or individuals receiving immunosuppressive therapy).
Slovenian: Pri dajanju cepiva RotaTeq otrokom, 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 imunosupresivno obliko zdravljenja) je potrebna previdnost.
English: Age-specific - 1st year of life - 2nd year of life - 3rd year of life - 4th year of life - 5th year of life - 6th-7th year of life
Slovenian: glede na sev - G1P[8] - G2P[4] - G3P[8] - G12P[8] glede na starost - 1. leto življenja - 2. leto življenja - 3. leto življenja - 4. leto življenja - 5. leto življenja - 6.-7. leto življenja
English: Efficacy against genotypes G2P[4], G3P[8], G4P[8] and G9P[8] rotavirus was based on fewer cases than for G1.
Slovenian: Učinkovitost proti rotavirusom genotipov G2P[4], G3P[8], G4P[8] in G9P[8] je temeljila na manjšem številu primerov kot za G1.
English: In clinical trials, efficacy was demonstrated against gastroenteritis due to rotavirus of genotypes G1P[8], G2P[4], G3P[8], G4P[8], and G9P[8].
Slovenian: V kliničnih preskušanjih so dokazali učinkovitost proti gastroenteritisu, ki ga povzročajo rotavirusi genotipov G1P[8], G2P[4], G3P[8], G4P[8] in G9P[8].
English: Previous history of intussusception.
Slovenian: Predhodna invaginacija v anamnezi.
English: α
Slovenian: V
English: 6 Infectious Units P1A[8] 2.3 x 10
Slovenian: P1A[8] 2,3 x 10
English: Waarderweg 39, 2031 BN Haarlem, P.O.
Slovenian: Waarderweg 39, 2031 BN Haarlem, P.O. Box 581, 2003 PC Haarlem
English: This leaflet was last revised in:
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: Co-administration of RotaTeq with DTaP-IPV-HBV-Hib vaccine (Infanrix hexa) at approximately 2, 3, and 4 months of age demonstrated that the immune responses and the safety profiles of the co-administered vaccines were unaffected compared to separate administrations.
Slovenian: Pri sočasni uporabi cepiva RotaTeq s cepivom DTaP-IPV-HBV-Hib (Infanrix hexa) pri približno 2, 3 in 4 mesecih starosti se je pokazalo, da se imunski odziv in varnostni profil sočasno prejetih cepiv v primerjavi z ločeno uporabo nista spremenila.
English: RotaTeq does not protect against diarrhoea and vomiting due to causes other than rotavirus.
Slovenian: Cepivo RotaTeq ne ščiti pred drisko in bruhanjem zaradi drugih vzrokov in ne rotavirusov.
English: Tear open the protective bag and remove the dosing tube.
Slovenian: Zaščitno vrečko raztrgajte in iz nje vzemite odmerno tubo.
English: • Rare (may affect up to 1 in 1000 infants): hives
Slovenian: • redki (pojavijo se lahko pri največ 1 od 1.000 dojenčkov): koprivnica
English: MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561
Slovenian: MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de
English: Based on pooled data from 3 clinical trials in which 6,130 infants received RotaTeq and 5,560 received placebo, the adverse reactions listed occurred with excess incidences in RotaTeq recipients compared to placebo recipients of between 0.2 % and 2.5 %.
Slovenian: Glede na podatke, zbrane iz 3 kliničnih preskušanj, v katerih je 6.130 dojenčkov dobilo RotaTeq, 5.560 dojenčkov pa placebo, je bila pojavnost naštetih neželenih učinkov pri prejemnikih cepiva RotaTeq v primerjavi s placebom za 0,2 % do 2,5 % večja.
English: As with any vaccine, vaccination with RotaTeq may not result in complete protection in all recipients.
Slovenian: Tako kot druga cepiva tudi cepivo RotaTeq morda ne bo popolnoma zaščitilo vseh cepljenih oseb.
English: Overall, 47 % of infants given RotaTeq experienced an adverse reaction compared with 45.8 % of infants given placebo.
Slovenian: Neželeni učinki so se pojavili pri skupno 47 % otrok, ki so prejeli cepivo RotaTeq, in 45,8 % otrok, ki so prejeli placebo.
English: Thus human data on use during pregnancy or lactation are not available and animal fertility or reproduction studies have not been performed.
Slovenian: Podatkov za človeka o uporabi med nosečnostjo ali v obdobju dojenja ni na voljo.
English: It might be necessary to postpone the vaccination until recovery.
Slovenian: Morda bo cepljenje potrebno odložiti, dokler se otrok ne pozdravi.
English: RotaTeq oral solution Rotavirus vaccine, live
Slovenian: RotaTeq peroralna raztopina cepivo proti rotavirusom, živo
English: After your child has received RotaTeq, 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 pri vašem otroku po prejetju cepiva RotaTeq pojavijo hude bolečine v želodcu, ponavljajoče bruhanje, kri v blatu, otekel trebuh in/ali zvišana telesna temperatura, nemudoma obvestite zdravnika/zdravstveno osebje (glejte tudi poglavje 4 "Možni neželeni učinki").
English: Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID) has been reported post-marketing.
Slovenian: O gastroenteritisu z izločanjem cepilnega virusa so v obdobju trženja poročali pri dojenčkih s hudo kombinirano imunsko pomanjkljivostjo (SCID).
English: The administration of RotaTeq should be postponed in subjects suffering from acute diarrhoea or vomiting.
Slovenian: Cepljenje s cepivom RotaTeq je treba odložiti pri osebah z akutno drisko ali bruhanjem.
English: Other medicines and RotaTeq:
Slovenian: Druga zdravila in cepivo RotaTeq
English: - your child was born with a malformation of the gastrointestinal system that might predispose for intussusception.
Slovenian: - če se je rodil z nepravilnostjo v prebavilih, zaradi katere bi bil lahko nagnjen k invaginaciji.
English: RotaTeq may be given at the same time as your child receives other normally recommended vaccinations, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, inactivated or oral poliomyelitis, hepatitis B, pneumococcal conjugate and meningococcus group C conjugate vaccines.
Slovenian: Cepivo RotaTeq se lahko daje sočasno z drugimi običajno priporočenimi cepivi, kot so cepivo proti davici, tetanusu in oslovskemu kašlju, cepivo proti Haemophilusu influenzae tipa b, inaktivirano ali peroralno cepivo proti otroški ohromelosti, cepivo proti hepatitisu B, konjugirano cepivo proti pnevmokokom in konjugirano cepivo proti meningokoku skupine C.
English: Infectious Units As lower confidence limit (p = 0.95)
Slovenian: * reasortirani humano-bovini rotavirusi (živi), pridobljeni na celicah Vero infektivnih enot kot spodnja meja zaupanja (p = 0,95)
English: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Slovenian: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Francija
English: Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
Slovenian: United Kingdom Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
English: In a clinical study, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks.
Slovenian: V klinični študiji je cepivo RotaTeq prejelo približno 1.000 nedonošenčkov, rojenih od 25. do 36. tedna nosečnosti.
English: RotaTeq Oral solution Oral use
Slovenian: RotaTeq peroralna raztopina peroralna uporaba
English: - your child has diarrhoea or is vomiting.
Slovenian: - če ima drisko ali če bruha.
English: The immune response to RotaTeq was unaffected when OPV was administered two weeks after RotaTeq.
Slovenian: Imunski odziv na cepivo RotaTeq je bil nespremenjen, če se je peroralno cepivo proti otroški ohromelosti apliciralo dva tedna po cepivu RotaTeq.
English: No increased risk of Kawasaki disease was observed among infants receiving RotaTeq in a large postmarketing observational safety surveillance study (see section 5.1).
Slovenian: V obsežni opazovalni študiji varnosti v obdobju trženja pri dojenčkih, ki so prejeli cepivo RotaTeq, niso opazili povečanega tveganja za Kawasakijevo bolezen (glejte poglavje 5.1).
English: It is important that your child receives all 3 doses of the vaccine for protection against rotavirus.
Slovenian: Za zaščito pred rotavirusom je pomembno, da otrok prejme vse 3 odmerke cepiva.
English: RotaTeq does not protect against gastroenteritis due to other pathogens than rotavirus.
Slovenian: Cepivo RotaTeq ne zaščiti pred gastroenteritisom, ki ga povzročijo drugi nerotavirusni patogeni.
English: Peak excretion occurred within 7 days of dosing.
Slovenian: Izločanje je bilo največje v sedmih dneh po prejemu odmerka.
English: How to use RotaTeq.
Slovenian: Kako uporabljati cepivo RotaTeq.
English: 2 ml solution in a pre-filled squeezable tube (LDPE), with a twist-off cap (HDPE) in a protective bag, pack size of 1 or 10 pre-filled squeezable tube(s).
Slovenian: 2 ml raztopine v napolnjeni stisljivi tubi (LDPE) z zaporko (HDPE) v zaščitni vrečki.
English: In phase III studies between 92.5 % and 100 % of recipients of RotaTeq achieved a significant rise in serum anti-rotavirus IgA after a three-dose regimen.
Slovenian: V študijah III. faze je bil po cepljenju s tremi odmerki pri 92,5 % do 100 % cepljenih oseb dosežen signifikanten porast serumskih protirotavirusnih IgA protiteles.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: If your child gets any side effects, talk to your doctor or pharmacist.
Slovenian: Če pri vašem otroku opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: Cases of gastroenteritis associated with vaccine virus have been reported post marketing in infants with severe combined immunodeficiency (SCID, see section 4.3).
Slovenian: V obdobju trženja so pri dojenčkih s hudo kombinirano imunsko pomanjkljivostjo (SCID) poročali o primerih gastroenteritisa, povezanega s cepilnim virusom (glejte poglavje 4.3).
English: What RotaTeq looks like and contents of the pack
Slovenian: Izgled cepiva RotaTeq in vsebina pakiranja peroralna raztopina