natgillin/translations-raw huggingface dataset:
Administration of RotaTeq may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.
O dajanju cepiva RotaTeq takšnim otrokom mora zdravnik skrbno razmisliti, še posebej, če je mnenja, da bi bilo necepljenje povezano z večjim tveganjem.
The level of protection provided by RotaTeq is based on the completion of all 3 doses.
Osnova za dosego stopnje zaščite, ki jo zagotavlja cepivo RotaTeq, je prejem vseh treh odmerkov cepiva.
RotaTeq does not protect against gastroenteritis due to other pathogens than rotavirus.
RotaTeq ne zaščiti pred gastroenteritisu, ki ga povzročijo drugi nerotavirusni patogeni.
During these trials, the most common circulating rotavirus serotype was G1P1[8], while rotavirus serotypes G2P[4], G3P1[8], G4P1[8], and G9P1[8] were identified less often.
Serotipi G2P[ 4], G3P1[ 8], G4P1[ 8] in G9P1[ 8] so bili odkriti redkeje.
The extent of protection that RotaTeq might provide against other rotavirus serotypes and in other populations is unknown.
Stopnja zaščite, ki se jo lahko doseže s cepivom RotaTeq proti drugim serotipom rotavirusov in pri drugih populacijah, ni znana.
No clinical data are available on the use of RotaTeq for post-exposure prophylaxis.
Klinični podatki o uporabi cepiva RotaTeq za postekspozicijsko profilakso niso na voljo.
Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine.
Bolniki z redkimi dednimi težavami intolerance za fruktozo, malabsorpcije glukoze in galaktoze ali pomanjkanja saharaze in izomaltaze tega cepiva ne smejo prejeti.
Clinical studies that involved co-administration of RotaTeq with a range of other routine infant vaccines at 2, 4 and 6 months of age demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected.
Klinične študije, ki so zajele sočasno uporabo cepiva RotaTeq z vrsto drugih rutinskih cepiv za dojenčke pri 2, 4 in 6 mesecih starosti, so pokazale da se imunski odziv in varnostni profil prejetih cepiv nista spremenila.
Therefore, RotaTeq can be given concomitantly with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTaP- HBV-IPV/ Hib)]: diphtheria-tetanus-acellular pertussis vaccine (DTaP), Haemophilus influenzae type b vaccine (Hib), inactivated or oral poliomyelitis vaccine (IPV or OPV; see below), hepatitis B vaccine (HBV) and pneumococcal conjugate vaccine.
Zato se cepivo RotaTeq lahko daje sočasno s katerimkoli od sledečih eno - valentnih ali kombiniranih cepiv [vključno s šestvalentnimi cepivi (DtaP- HBV- IPV/ Hib)]: cepivom proti davici, tetanusu in oslovskem kašlju (DTaP), cepivom proti Haemophilusu influenzae tipa b (Hib), inaktiviranim ali peroralnim cepivom proti otroški ohromelosti (IPV ali OPV, glejte spodaj), cepivom proti hepatitisu B (HBV) in konjugiranim cepivom proti pneumokokom.
Concomitant administration of RotaTeq and oral poliomyelitis vaccine (OPV) does not affect the immune response to the poliovirus antigens.
Sočasno dajanje cepiva RotaTeq in peroralnega cepiva proti otroški ohromelosti (OPV) ne vpliva na imunski odziv na antigene poliovirusa.
Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, there is currently no evidence that clinical protection against severe rotavirus gastroenteritis would be affected.
Čeprav sočasna uporaba OPV lahko neznatno zniža imunski odziv na cepivo proti rotavirusu, zaenkrat ni dokazov za spremenjeno klinično učinkovitost pri preprečevanju resnega gastroenteritisa.
The immune response to RotaTeq is unaffected when OPV is administered two weeks after RotaTeq.
Imunski odziv na cepivo RotaTeq je nespremenjen, če se cepivo proti otroški ohromelosti aplicira dva tedna po cepivu RotaTeq.
RotaTeq is intended for use in infants only.
RotaTeq je namenjen samo za uporabo pri dojenčkih.
Thus human data on use during pregnancy or lactation are not available and animal reproduction studies have not been performed.
Študije na živalih glede sposobnosti razmnoževanja niso bile izvedene.
In a subset of infants from 3 placebo-controlled clinical trials (n=6,130 recipients of RotaTeq and 5,560 placebo recipients), RotaTeq was evaluated for all adverse events within 42 days of vaccination with or without concomitant use of other paediatric vaccines.
Pri podskupini dojenčkov, ki so bile vključeni v 3 s placebom nadzorovana klinična preskušanja (6. 130 dojenčkov, ki so prejeli cepivo RotaTeq, 5. 560 dojenčkov, ki so prejeli placebo) so vrednotili vse neželene dogodke cepiva RotaTeq, ki so se pojavili v 42 dneh po cepljenju.
Overall, 47% of infants given RotaTeq experienced an adverse reaction compared with 45.8% of infants given placebo.
Neželene reakcije so se pojavile pri skupno 47% otrok, ki so prejeli cepivo RotaTeq, in 45, 8% otrok, ki so prejeli placebo.
The most commonly reported adverse reactions that occurred more frequently with vaccine than with placebo were pyrexia (20.9%), diarrhoea (17.6%) and vomiting (10.1%).
Neželene reakcije, o katerih so poročali najpogosteje in so bile po prejemu cepiva RotaTeq pogostejše kot po prejemu placeba, so bile: povišana telesna temperatura (20, 9%), driska (17, 6%) in bruhanje (10, 1%).
Adverse reactions more common in the vaccine group are listed below per system organ class and frequency.
Neželene reakcije, ki so bile pogostejše v skupini, ki je dobila cepivo, so spodaj razvrščene glede na organski sistem in pogostost.
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%.
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 reakcij pri prejemnikih cepiva RotaTeq v primerjavi s placebom za 0, 2% do 2, 5% večja.
Frequencies are reported as:
Pogostost je označena kot:
Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100); Rare (≥ 1/ 10,000, < 1/ 1,000)
zelo pogoste (≥ 1/ 10); pogoste (≥ 1/ 100, < 1/ 10); občasne (≥ 1/ 1. 000, < 1/ 100); redke (≥ 1/ 10. 000, < 1/ 1. 000)
Nasopharyngitis
Infekcijske in parazitske bolezni Pogoste: okužba zgornjih dihal Občasne: nazofaringitis
Abdominal pain upper
Bolezni prebavil Zelo pogoste: driska, bruhanje Občasne: bolečina v zgornjem delu trebuha
Rash
Bolezni kože in podkožja Občasne: izpuščaj
Pyrexia
Splošne težave in spremembe na mestu aplikacije Zelo pogoste: zvišana telesna temperatura
Serious adverse reactions were assessed in all participants (36,150 recipients of RotaTeq and 35,536 placebo recipients) of 3 clinical trials for up to 42 days after each dose.
Pri vseh otrocih (36. 150 otrok, ki so prejeli cepivo RotaTeq, in 35. 536 otrok, ki so prejeli placebo), ki so bili vključeni v 3 klinična preskušanja za obdobje 42 dni po vsakem odmerku, so ocenili pojavnost resnih neželenih reakcij.
The overall frequency of these serious adverse reactions was 0.1% among recipients of RotaTeq and 0.2% among placebo recipients.
Pri otrocih, ki so prejeli cepivo RotaTeq, je bila pojavnost resnih neželenih reakcij 0, 1%, pri otrocih, ki so prejeli placebo, pa 0, 2%.
Kawasaki disease was reported in 5 of 36,150 vaccine recipients (< 0.1%) and 1 of 35,536 placebo recipients (< 0.1%) with a relative risk (RR) of 4.9 [95% CI, 0.6 – 239.1] (not statistically significant).
O Kawasakijevi bolezni so poročali pri 5 od 36. 150 prejemnikov cepiva (< 0, 1%) in pri 1 od 35. 536 prejemnikov placeba (< 0, 1%) z relativnim tveganjem 4, 9 [95- odstotni IZ, 0, 6- 239. 1] (statistično nepomembno).
Otitis media and bronchospasm were reported in significantly more vaccine than placebo recipients overall; however, among cases that were considered to be vaccine-related in the opinion of the study investigator, the incidence of otitis media (0.3%) and bronchospasm (< 0.1%) was the same for vaccine and placebo recipients.
Glede na število primerov, ki so jih raziskovalci pripisali cepivu, pa sta bili pojavnosti vnetja srednjega ušesa (0, 3%) in
Haematochezia was reported as an adverse experience in 0.6% (39/ 6,130) of vaccine recipients and 0.6% (34/ 5,560) of placebo recipients within 42 days of any dose (the difference was not statistically significant).
5 bronhospazma (< 0, 1%) enaki tako pri otrocih, ki so prejeli cepivo, kot pri otrocih, ki so prejeli placebo.
Intussusception The risk of intussusception has been evaluated in a placebo-controlled study in infants.
O hematoheziji kot neželenem učinku so poročali pri 0, 6% (39/ 6. 130) cepljenih s cepivom in pri 0, 6% (34/ 5. 560) prejemnikov placeba v obdobju 42 dni po prejemu kateregakoli odmerka (razlika ni bila statistično pomembna).
During the combined 42-day periods following each dose, there were 6 cases of intussusception in 34,837 recipients of RotaTeq compared with 5 cases in 34,788 placebo recipients.
Med 42 - dnevnim obdobjem po prejemu vsakega odmerka so poročali o šestih primerih invaginacije pri 34. 837 otrocih, ki so prejeli cepivo RotaTeq, in o petih primerih invaginacije pri 34. 788 otrocih, ki so prejeli placebo.
The 95% CI for the relative
95- odstotni interval zaupanja za relativno tveganje sta bila 0, 4, 6, 4.
There was no clustering of cases among recipients of RotaTeq at any time period after any dose.
Pri otrocih, ki so prejeli cepivo RotaTeq, kopičenja primerov v kateremkoli obdobju po prejemu kateregakoli odmerka niso opazili.
Post-marketing reports The following adverse experiences have been spontaneously reported with RotaTeq.
Postmarketinška poročila O naslednjih neželenih učinkih so poročali ob uporabi zdravila Rotateq.
Urticaria
Bolezni prebavil: hematohezija Bolezni kože in podkožja: urtikarija
Additional information on special populations:
Dodatne informacije za posebne skupine:
There are no data with regard to overdose.
Podatki o prevelikem odmerjanju niso na voljo.
Pharmacotherapeutic group: viral vaccines ATC code:
Farmakoterapevtska skupina: virusna cepiva Oznaka ATC:
Efficacy The protective efficacy of RotaTeq was evaluated in two ways in the placebo-controlled Rotavirus Efficacy and Safety Trial (REST):
Učinkovitost Zaščitna učinkovitost cepiva RotaTeq je bila v s placebom nadzorovanem preskušanju “ Rotavirus Efficacy and Safety Trial ” (REST) ovrednotena na dva načina:
In 5,673 vaccinated infants (2,834 in the vaccine group) protective efficacy was measured as a reduction in the incidence of rotavirus (RV) gastroenteritis caused by vaccine G serotypes (G1-G4) that occurred at least 14 days after the third dose of vaccine through the first full rotavirus season after vaccination.
Pri 5. 673 cepljenih otrocih (2. 834 otrok v skupini, ki je prejemala cepivo) je bila učinkovitost zaščite merjena kot zmanjšanje pojavnosti rotavirusnega (RV) gastroenteritisa, povzročenega s serotipi cepiva (G1- G4) vsaj 14 dni po prejemu tretjega odmerka cepiva med prvo celotno rotavirusno sezono po cepljenju.
In 68,038 vaccinated infants (34,035 in the vaccine group) protective efficacy was measured as a reduction in the rate of hospitalisations and emergency department visits for RV gastroenteritis from 14 days after the third dose.
Pri 68. 038 cepljenih otrocih (34. 035 otrok v skupini, ki je prejemala cepivo) je bila učinkovitost zaščite merjena kot zmanjšanje števila sprejemov v bolnišnico in obiskov enot za nujno medicinsko pomoč zaradi RV gastroenteritisa od 14. dneva po tretjem odmerku.
6 The results of these analyses are presented in the following tables.
Rezultati teh analiz so predstavljeni v tabelah v nadaljevanju.
Reduction in incidence of RV gastroenteritis through one full season post-vaccination (RotaTeq n=2,834) (% [95% CI]) Serotype Severe* disease
6 Zmanjšanje pojavnosti RV gastroenteritisa med eno celotno sezono po cepljenju (RotaTeq n = 2. 834)% (95- odstotni IZ) Serotip
Any
Huda *
severity (G1-G4)
intenzitete (G1- G4)
* Severe defined as a score > 16/ 24 using a validated clinical scoring system based on the intensity and duration of symptoms (fever, vomiting, diarrhoea and behavioural changes) † Statistically significant
* Huda bolezen je definirana z rezultatom > 16/ 24 pri uporabi potrjenega kliničnega ocenjevalnega sistema na osnovi intenzitete in trajanja simptomov (povišana telesna temperatura, bruhanje, driska in vedenjske spremembe) † Statistično pomembno
Reduction in hospitalisations and emergency department visits for RV gastroenteritis for up to 2 years post- vaccination (RotaTeq n=34,035) (% [95% CI])
Zmanjšanje števila sprejemov v bolnišnico/ obiskov enot za nujno medicinsko pomoč zaradi RV gastroenteritisa v času do dveh let po cepljenju (RotaTeq n = 34. 035)% (95- odstotni IZ)
Statistically significant
Statistično pomembno
The reduction in incidence of RV gastroenteritis caused by 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.
Pojavnost RV gastroenteritisa, povzročenega s serotipi G1- G4 je bila med drugo rotavirusno sezono po cepljenju manjša, in sicer pojavnost hude bolezni za 88, 0% [95- odstotni IZ, 49, 4; 98, 7], pojavnost bolezni katerekoli intenzitete pa za 62, 6% [95- odstotni IZ, 44, 3; 75, 4].
Efficacy against G2P[4], G3P[8], G4P[8] and G9P[8] rotavirus was based on fewer cases than for G1.
Učinkovitost proti rotavirusom G2P[ 4], G3P[ 8], G4P[ 8] in G9P[ 8] je temeljila na manjšem številu primerov kot za G1.
The efficacy observed against G2P[4] most likely resulted from the G2 component of the vaccine.
Učinkovitost, ki so jo opazili proti G2P[ 4], je najverjetneje povzročila G2 komponenta cepiva.
This Finnish Extension Study (FES) included a subset of 20,736 subjects that had been enrolled previously in REST.
V podaljšek študije na Finskem (FES – Finnish Extension Study) je bilo vključenih 20. 736 oseb, ki so bili že prej vključeni v REST.
In REST there were 403 healthcare encounters (20 in the vaccine group and 383 in the placebo group) associated with G1-G4 and G9 RV gastroenteritis in the per protocol population.
V REST je bilo 403 obiskov zdravnika (20 v skupini, ki je prejela cepivo, in 383 v skupini, ki je prejela placebo), povezanih z G1- G4 in G9 RV gastroenteritisom v per protocol populaciji.
Overall, 31% and 25% of the encounters in the respective groups occurred during the FES.
25% obiskov zdravnika v posamezni skupini pojavilo tekom FES.
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:
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) for serotypes G1-G4, 95.5% (95% CI:
91, 6; 96, 2) za serotipe G1- G4, 95, 5% (95- odstotni IZ:
92.8, 97.2) for serotype G1, 81.9% (95% CI:
92, 8; 97, 2) za serotip G1, 81, 9% (95 - odstotni IZ:
16.1, 98.0) for serotype G2, 89.0% (95% CI:
16, 1; 98, 0) za serotip G2, 89, 0% (95- odstotni IZ:
53.3, 98.7) for serotype G3, 83.4% (95% CI:
53, 3; 98, 7) za serotip G3, 83, 4% (95 - odstotni IZ:
51.2, 95.8) for serotype G4, and 94.2% (95% CI:
51, 2; 95, 8) za serotip G4 in 94, 2% (95- odstotni IZ:
62.2, 99.9) for serotype G9.
62, 2; 99, 9) za serotip G9.
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).
V 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.
A complete 3-dose vaccination series of RotaTeq should be administered (see section 4.2) to provide the level and duration of protection against rotavirus gastroenteritis that was observed in the clinical studies.
Za takšen obseg in trajanje zaščite proti rotavirusnemu gastroenteritisu, kot so jih opazili v kliničnih študijah, je potrebno cepljenje z vsemi 3 odmerki cepiva RotaTeq (glejte poglavje 4. 2).
However, post hoc analyses indicated that RotaTeq achieved some reduction in the numbers of cases of rotavirus gastroenteritis of sufficient severity to require hospitalisation or an emergency department visit before completion of all three doses (i.e. from approximately 14 days after administration of the first dose onwards).
Vendar pa so naknadne analize pokazale, da so s cepivom RotaTeq neko zmanjšanje števila primerov rotavirusnega gastroenteritisa, dovolj hudega, da je zahteval hospitalizacijo ali obisk nujne zdravniške pomoči, dosegli pred zaključkom cepljenja z vsemi tremi odmerki (to je od približno 14. dneva po prvem odmerku).
7 In REST, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks.
7 Učinkovitost pri nedonošenčkih V študiji REST so cepivo RotaTeq dajali približno 1. 000 nedonošenčkom, ki so bili rojeni od 25. do 36. tedna nosečnosti.
Immunogenicity The immunological mechanism by which RotaTeq protects against rotavirus gastroenteritis is not completely understood.
Imunogenost Imunološki mehanizem, s katerim cepivo RotaTeq ščiti pred rotavirusnim gastroenteritisom, ni popolnoma pojasnjen.
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.
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.
The vaccine induces an immune response (i.e., appearance of serum neutralising antibody) to the five human-rotavirus proteins expressed on the reassortants (G1, G2, G3, G4 and P1[8]).
Cepivo sproži imunski odziv (npr. pojav serumskih nevtralizirajočih protiteles) na pet humanih rotavirusnih proteinov, vključenih v prerazporejene rotaviruse (G1, G2, G3, G4 in P1[ 8]).
A single and repeated dose oral toxicity study in mice suggests no special hazard to humans.
Študije toksičnosti enega samega peroralnega odmerka in ponavljajočih se odmerkov, izvedene na miših, ne kažejo posebnega tveganja za človeka.
The dose administered to mice was approximately 2.79 x 108 infectious units per kg (about 14-fold the projected infant dose).
Odmerek, ki so ga dajali mišim, je bil približno 2, 79 X 108 infektivnih enot na kg (približno 14- kratni odmerek, ki je predviden za cepljenje otrok).
RotaTeq is unlikely to pose any environmental risk.
Verjetnost, da bi cepivo RotaTeq predstavljalo kakršnokoli tveganje za okolje, je majhna.
See section 6.6.
Glejte poglavje 6. 6.
Sucrose Sodium citrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide Polysorbate 80 Culture media (containing inorganic salts, amino acids and vitamins) Purified water
saharoza natrijev citrat natrijev dihidrogenfosfat monohidrat natrijev hidroksid polisorbat 80 medij za gojišče (vsebuje anorganske soli, aminokisline in vitamine) prečiščena voda
The vaccine must not be mixed with other medicinal products.
Cepiva ne smemo mešati z drugimi zdravili.
RotaTeq should be administered promptly after removal from refrigeration.
Ko cepivo RotaTeq vzamete iz hladilnika, ga morate nemudoma aplicirati.
Store in a refrigerator (2 °C – 8 °C).
Cepivo shranjujte in prevažajte na hladnem (2 °C – 8 °C).
Keep the dosing tube in the outer carton in order to protect from light.
Odmerno tubo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
8 6.5 Nature and contents of container
8 6. 5 Vrsta ovojnine in vsebina
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 in a pack of 10.
1 ali 10.
The vaccine is to be administered orally without mixing with any other vaccines or solutions.
Ne razredčujte.
Do not dilute.
Aplikacija cepiva:
To administer the vaccine:
Raztrgajte zaščitno vrečko in iz nje vzemite odmerno tubo.
Tear open the protective bag and remove the dosing tube.
Tubo držite v navpičnem položaju in s frcanjem pokrovčka iz konice tube odstranite tekočino.
Clear the fluid from the dispensing tip by holding tube vertically and tapping the twist-off cap.
Konico tube preluknjajte tako, da zaporko vrtite v smeri urinega kazalca, dokler ne začutite odpora.
Open the dosing tube in 2 easy motions:
2.
Puncture the dispensing tip by screwing cap clockwise until it becomes tight.
Zaporko odstranite tako, da jo zavrtite proti smeri urinega kazalca.
Remove cap by turning it counterclockwise.
Aplicirajte odmerek.
(A residual drop may remain in the tip of the tube.)
Otroku tekočino nežno iztisnete v usta v smeri proti notranji strani lica, dokler odmerna tuba ni prazna (v konici tube lahko ostane kapljica raztopine).
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 LYON France
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F- 69007 LYON Francija
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
Name of Company:
Ime izdelovalca:
Merck & Co., Inc Sumneytown Pike – PO Box 4 – West Point – Pennsylvania 19486 United States of America +1 215 652 5603
Merck & Co., Inc Sumneytown Pike – PO Box 4 – West Point – Pennsylvania 19486 Združene države Amerike +1 215 652 5603
manufacturer responsible for batch release
Ime in naslov izdelovalca, odgovornega za sproščanje serije
Box 581, 2003 PC Haarlem the Netherlands +31 23 5153153 +31 23 5148000
Box 581, 2003 PC Haarlem Nizozemska +31 23 5153153 +31 23 5148000
RotaTeq – Pack size of 1 single-dose(2ml) Tube RotaTeq – Pack size of 10 single-dose(2ml) Tubes
1.
RotaTeq, oral solution Rotavirus vaccine (live, oral)
RotaTeq peroralna raztopina cepivo proti rotavirusom (živo, peroralno)
One 2 ml dose contains rotavirus serotype*:
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN
G1 ≥ 2.2 x 106 IU1 G2 ≥ 2.8 x 106 IU1 G3 ≥ 2.2 x 106 IU1 G4 ≥ 2.0 x 106 IU1 P1[8] ≥ 2.3 x 106 IU1
En 2 ml odmerek vsebuje serotip * rotavirusa: ≥ 2, 2 x 106 i. e. 1 G1 ≥ 2, 8 x 106 i. e. 1 G2 ≥ 2, 2 x 106 i. e. 1 G3 ≥ 2, 0 x 106 i. e. 1 G4 ≥ 2, 3 x 106 i. e. 1 P1[ 8]
1 Infectious Units
* prerazporejeni humano- bovini rotavirusi (živi), pridobljeni na celicah Vero 1 infektivnih enot
2 ml oral solution in a tube pack size of 1 tube pack size of 10 tubes
10 tub
FOR ORAL USE ONLY Read the package leaflet before use
SAMO ZA PERORALNO UPORABO Pred uporabo preberite priloženo navodilo.
Store in a refrigerator Keep the dosing tube in the outer carton in order to protect from light.
Odmerno tubo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
Please read the package leaflet for disposal of medicines no longer required
Za odstranjevanje cepiva, ki ga ne rabite več, preberite, prosimo, navodilo za uporabo.
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F-69007 Lyon France
Sanofi Pasteur MSD, SNC 8, rue Jonas Salk F- 69007 Lyon Francija
EU/1/06/348/001 pack of 1 tube EU/1/06/348/002 pack of 10 tubes
EU/ 0/ 00/ 000/ 001 škatla z 1 tubo EU/ 0/ 00/ 000/ 002 škatla z 10 tubami
16 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Text for the protective bag
PODATKI V BRAILLOVI PISAVI
RotaTeq, oral solution Rotavirus vaccine, (live, oral)
RotaTeq peroralna raztopina cepivo proti rotavirusom (živo, peroralno)
RotaTeq Oral solution Oral use
RotaTeq Peroralna raztopina Peroralna uporaba
RotaTeq, oral solution Rotavirus vaccine (live oral)
RotaTeq peroralna raztopina cepivo proti rotavirusom (živo, peroralno)
Read all of this leaflet before your child is vaccinated.
Preden bo vaš otrok prejel cepivo, natančno preberite navodilo!
- If you have any further questions, ask your doctor/health care professional.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali drugim zdravstvenim osebjem.
please tell your doctor/health care professional.
omenjen v tem navodilu, obvestite svojega zdravnika ali drugo zdravstveno osebje.
What RotaTeq is and what it is used for 2.
Kaj je cepivo RotaTeq in za kaj ga uporabljamo 2.
Before your child receives RotaTeq 3.
Kaj morate vedeti, preden bo vaš otrok prejel cepivo RotaTeq 3.
How RotaTeq is given 4.
Kako se cepivo RotaTeq daje 4.
How to store RotaTeq 6.
Shranjevanje cepiva RotaTeq 6.