natgillin/translations-raw huggingface dataset:
Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was shown to be maintained in a clinical trial involving more than 4200 subjects who received Rotarix concomitantly with OPV.
Zaradi sočasnega dajanja cepiva Rotarix in OPV se imunski odziv na cepivo proti rotavirusom sicer lahko nekoliko zmanjša, vendar pa je klinično preskušanje, v katerega je bilo vključenih več kot 4. 200 oseb, ki so cepivo Rotarix prejele skupaj z OPV pokazalo, da se je klinična zaščita proti hudi obliki rotavirusnega gastroenteritisa ohranila.
There are no restrictions on the infant’ s consumption of food or liquid, either before or after vaccination.
Glede uživanja hrane ali tekočine pred ali po aplikaciji cepiva ni omejitev.
Thus human data on use during pregnancy or lactation are not available and animal reproduction studies have not been performed.
Študije o vplivih na sposobnost razmnoževanja pri živalih niso bile izvedene.
• Clinical trials
• Klinične študije:
4 In a total of eleven placebo-controlled clinical trials, approximately 77800 doses of Rotarix were administered to approximately 40200 infants.
Izvedenih je bilo enajst s placebom nadzorovanih kliničnih preskušanj, v katerih je približno 40200 otrok prejelo približno 77800 odmerkov cepiva Rotarix.
In two clinical trials (Finland), Rotarix was administered alone (administration of routine paediatric vaccines was staggered).
V dveh kliničnih preskušanjih (Finska) so otroci prejeli samo cepivo Rotarix (rutinsko cepljenje z drugimi cepivi je bilo odloženo).
The incidence of diarrhoea, vomiting, loss of appetite, fever and irritability was not different in the group receiving Rotarix when compared to the group receiving placebo.
V skupini, ki je prejela cepivo Rotarix se pojavnost driske, bruhanja, izgube apetita, povišane telesne temperature in razdražljivosti ni razlikovala od pojavnosti v skupini, ki je prejela placebo.
No increase in the incidence or severity of these reactions was seen with the second dose.
Po aplikaciji drugega odmerka se pojavnost ali resnost omenjenih reakcij ni povečala.
In the remaining nine trials (Europe, Canada, USA, Latin America, Singapore, South-Africa), Rotarix was co-administered with routine paediatric vaccines (see section 4.5).
V preostalih devetih preskušanjih (Evropa, Kanada, Združene države Amerike, Latinska Amerika, Singapur, Južna Afrika) so otroci sočasno s cepivom Rotarix prejeli tudi druga rutinska cepiva (glejte poglavje 4. 5).
The adverse reaction profile observed in these subjects was similar to the adverse reaction profile observed in subjects receiving the same paediatric vaccines and placebo.
Profil neželenih učinkov se pri teh otrocih ni razlikoval od profila neželenih učinkov pri otrocih, ki so sočasno z istimi rutinskimi cepivi prejeli placebo.
Adverse reactions are listed below per system organ class and frequency.
Neželeni učinki so v nadaljevanju navedeni glede na organski sistem in pogostnost.
Very common (≥ 1/ 10) Common (≥ 1/ 100, < 1/ 10) Uncommon (≥ 1/ 1,000, < 1/ 100) Rare (≥ 1/ 10,000, < 1/ 1,000)
Zelo pogosti (≥ 1/ 10) Pogosti (≥ 1/ 100, < 1/ 10) Občasni (≥ 1/ 1. 000, < 1/ 100) Redki (≥ 1/ 10. 000, < 1/ 1. 000)
Nervous system disorders Uncommon: somnolence
Bolezni živčevja Občasni: somnolenca
Respiratory, thoracic and mediastinal disorders Rare: hoarseness, rhinorrhoea
Bolezni dihal, prsnega koša in mediastinalnega prostora Redki: hripavost, rinoreja
Gastrointestinal disorders Very common: loss of appetite Common: diarrhoea, vomiting, abdominal pain, flatulence, regurgitation of food Uncommon: constipation
Bolezni prebavil Zelo pogosti: izguba apetita Pogosti: driska, bruhanje, abdominalna bolečina, flatulenca, regurgitacija hrane Občasni: obstipacija
Skin and subcutaneous tissue disorders Rare: dermatitis, rash
Bolezni kože in podkožja Redki: dermatitis, izpuščaj
Musculoskeletal and connective tissue disorders Rare: muscle cramp
Bolezni mišično- skeletnega sistema in vezivnega tkiva Redki: mišični krči
Infections and infestations Rare: upper respiratory tract infection General disorders and administration site conditions Common: fever, fatigue
Infekcijske in parazitske bolezni Redki: okužba zgornjih dihalnih poti
Psychiatric disorders Very common: irritability Uncommon: sleep disorder, crying
Psihiatrične motnje Zelo pogosti: razdražljivost Občasni: jok, motnje spanja
The risk of intussusception has been evaluated in a large safety trial conducted in Latin America and Finland where 63225 subjects were enrolled.
V preskušanje je bilo vključenih 63225 oseb.
This trial gave evidence of no increased risk of intussusception in the Rotarix group when compared with the placebo group as shown in the table below.
Kot je razvidno iz tabele v nadaljevanju, tveganje za pojav invaginacije ni bilo povečano v skupini, ki je prejela cepivo Rotarix, v primerjavi s skupino, ki je prejela placebo.
Intussusception within 31 days after administration of:
Invaginacija v 31 dneh po
Relative risk (95% CI*)
Relativno tveganje (95% IZ *)
First dose
aplikaciji:
1
1 2 5 5
0.50 (0.07; 3.80)
0, 50 (0, 07; 3, 80) 0, 99 (0, 31; 3, 21)
Second dose *CI: confidence interval
* IZ: interval zaupanja (CI – » confidential interval «)
Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Apneja pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti) (glejte poglavje 4. 4).
Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code:
Cepiva proti rotavirusom (povzročitelji gastroenteritisov), oznaka ATC:
Protective efficacy
Učinkovitost zaščite
Clinical studies have been conducted in Europe and Latin America to evaluate the protective efficacy of Rotarix against any and severe rotavirus gastro-enteritis.
Klinične študije, ki so vrednotile učinkovitost zaščite pred katerim koli rotavirusnim gastroenteritisom oziroma pred hudim rotavirusnim gastroenteritisom so bile izvedene v Evropi in Latinski Ameriki.
A clinical study performed in Europe evaluated Rotarix given according to different European schedules (2, 3 months; 2, 4 months; 3, 4 months; 3, 5 months) in 4000 subjects.
Klinična študija, izvedena v Evropi je pri približno 4. 000 osebah vrednotila dajanje cepiva Rotarix po različnih shemah dajanja, ki se uporabljajo v Evropi (2 in 3 mesec; 2 in 4 mesec; 3 in 4 mesec; 3 in 5 mesec).
Severity of gastro- enteritis was defined according to the Vesikari 20-point scale which evaluates the full clinical picture of rotavirus gastro-enteritis by taking into account the severity and duration of diarrhoea and vomiting, the severity of fever and dehydration as well as the need for treatment.
Resnost gastroenteritisa so definirali v skladu z 20- točkovno Vesikari- jevo lestvico, ki upošteva tako celotno klinično sliko rotavirusnega gastroenteritisa (resnost in trajanje driske ter bruhanja, resnost povišane telesne temperature in dehidracije) kot tudi potrebo po zdravljenju.
After two doses of Rotarix, the protective vaccine efficacy observed during the first and second year of life is presented in the following table:
6 V spodnji tabeli je prikazana učinkovitost zaščite cepiva med prvim in drugim letom življenja po aplikaciji dveh odmerkov cepiva Rotarix:
Vaccine efficacy (%) against any and severe rotavirus gastro-enteritis [95% CI]
Drugo leto življenja Prvo leto življenja Rotarix N=2. 554; Rotarix N=2. 572; Placebo N=1. 294 (§) Placebo N=1. 302 (§) Učinkovitost cepiva (%) proti rotavirusnemu gastroenteritisu katerekoli jakosti in proti hudemu rotavirusnemu gastroenteritisu [95% IZ]
Type
Hud †
Any severity
Hud †
Severe† Any se
Serotip
Any severity Severe† Any severity
Katerakoli jakost
Severe†
Katerakoli jakost
Strains with P[8]
Sevi s P[ 8]
genotype
genotipom
Circulating
Krožeči sevi
rotavirus strains
rotavirusov
Vaccine efficacy (%) against rotavirus gastro-enteritis requiring medical attention [95% CI]
Učinkovitost cepiva (%) proti rotavirusnemu gastroenteritisu, pri katerem je potrebno zdravljenje [95% IZ]
Vaccine efficacy (%) against hospitalisation due to rotavirus gastro-enteritis [95% CI]
Učinkovitost cepiva (%) proti rotavirusnemu gastroenteritisu, pri katerem je potrebno zdravljenje v bolnišnici [95% IZ]
Severe gastro-enteritis defined as a score ≥11 on the Vesikari scale (§) ATP cohort for efficacy * Statistically significant (p < 0.05)
(§) kohorta po protokolu za učinkovitost * Statistično pomembno (p < 0, 05)
Vaccine efficacy during the first year of life progressively increased with increasing disease severity, reaching 100% (95% CI:
Med prvim letom življenja se učinkovitost cepiva progresivno povečuje s povečevanjem resnosti bolezni in pri oceni ≥ 17 po Vesikari- ju doseže 100% (95% interval zaupanja:
84.7;100) for Vesikari scores ≥17.
84, 7; 100).
A clinical study performed in Latin America evaluated Rotarix in more than 20000 subjects.
7 Klinična študija, izvedena v Latinski Ameriki, je cepivo Rotarix ovrednotila pri več kot 20000 osebah.
Severity of gastro-enteritis was defined according to WHO criteria.
Resnost gastroenteritisa je bila definirana po kriterijih Svetovne zdravstvene organizacije.
The protective vaccine efficacy against severe rotavirus gastro-enteritis requiring hospitalisation and/or rehydration therapy in a medical facility and the type specific vaccine efficacy after two doses of Rotarix are presented in the table below:
Učinkovitost zaščite cepiva proti hudemu rotavirusnemu gastroenteritisu, pri katerem je potreben sprejem v bolnišnico in/ ali rehidracijsko zdravljenje v zdravstvenih ustanovah in serotipsko specifična učinkovitost cepiva po prejemu dveh odmerkov cepiva Rotarix sta predstavljeni v spodnji tabeli:
Type
Serotip
Severe rotavirus gastro- enteritis (1st year of life) Rotarix N=9009; Placebo N=8858(§) Efficacy (%) [95% CI]
Hud rotavirusni gastroenteritis (prvo leto življenja) Rotarix N = 9. 009; Placebo N = 8. 858( §) Učinkovitost (%) [95% IZ]
Severe rotavirus gastro- enteritis (2nd year of life) Rotarix N=7175; Placebo N=7062 (§) Efficacy (%) [95% CI]
rotavirusni gastroenteritis (drugo leto življenja) Rotarix N = 7. 175; Placebo N = 7. 062( §) Učinkovitost (%) 95% IZ
Strains with P[8] genotype
Sevi z genotipom P[ 8]
(§) ATP cohort for efficacy * Statistically significant (p < 0.05) # The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very small (1 case in the Rotarix group and 2 cases in the placebo group).
(§) kohorta po protokolu za učinkovitost * Statistično pomembno (p < 0, 05) # Število oseb na katerih temelji ocena učinkovitosti proti G4P[ 8] je zelo majhno (1 oseba v skupini, ki je prejela cepivo Rotarix in 2 osebi v skupini, ki je prejela placebo).
A pooled analysis of five efficacy studies*, showed a 71.4% (95% CI:20.1;91.1) efficacy against severe rotavirus gastro-enteritis (Vesikari score ≥11) caused by rotavirus G2P[4] type during the first year of life. * In these studies, the point estimates and confidence intervals were respectively:
20, 1; 91, 1). * Ocenjene vrednosti in intervali zaupanja iz teh študij:
100% (95% CI: - 1858.0;100), 100% (95% CI:
100% (95% interval zaupanja: - 1858, 0; 100), 100% (95% interval zaupanja:
21.1;100), 45.4% (95% CI: -81.5;86.6), 74.7 (95% CI :-386.2;99.6).
21, 1; 100), 45, 4% (95% interval zaupanja: - 81, 5; 86, 6) in 74, 7% (95% interval zaupanja: - 386, 2; 99, 6).
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.
7 The following table shows the percentage of subjects with serum anti-rotavirus IgA antibody titers ≥ 20U/ml (by ELISA) one to two months after the second dose of vaccine or placebo as observed in different studies.
8 V spodnji tabeli so prikazani odstotki oseb, pri katerih je bil en ali dva meseca po aplikaciji drugega odmerka cepiva ali placeba v različnih študijah dosežen titer serumskih protirotavirusnih IgA protiteles ≥ 20 E/ ml (ELISA).
% ≥ 20U/ml [95% CI]
% ≥ 20 E/ ml [95% IZ]
2, 3 months
2 in 3 mesec
France, Germany
Francija,
2, 4 months
2 in 4 mesec
3, 5 months
3 in 5 mesec
3, 4 months
3 in 4 mesec
2, 3 to 4 months
2 in 3 do 4
Latin America; 11 countries
Latinska
15.1% [11.7;19.0]
Amerika; 11 držav
Powder Sucrose Dextran Sorbitol Amino acids Dulbecco’s Modified Eagle Medium (DMEM)
Prašek saharoza dekstran sorbitol aminokisline Dulbekov spremenjeni nujni medij (DMEM – » Dulbecco’ s Modified Eagle Medium «)
Solvent Calcium carbonate Xanthan gum Sterile water
Vehikel kalcijev karbonat ksantanski gumi voda za injekcije
8 After the reconstitution, the vaccine should be administered immediately.
Rekonstituirano cepivo je treba nemudoma aplicirati.
However, experimental data have shown that the reconstituted vaccine is stable when stored for 24 hours at ambient temperature (18-25°C).
9 Eksperimentalni podatki kažejo, da je rekonstituirano cepivo stabilno 24 ur, če se ga shranjuje pri sobni temperaturi (18- 25 °C).
These data are not recommendations for storage.
Ti podatki niso priporočila za shranjevanje.
In case of temporary storage of the powder and the solvent outside the refrigerator, experimental data have shown that the powder as well as the solvent are stable when stored at temperatures up to 37°C for 1 week.
V primeru začasnega shranjevanja praška in vehikla zunaj hladilnika eksperimentalni podatki kažejo, da sta tako prašek kot vehikel stabilna 1 teden, če se ju shranjuje pri temperaturi do 37 °C.
For storage conditions of the reconstituted product, see section 6.3.
Za pogoje shranjevanja rekonstituiranega cepiva glejte poglavje 6. 3.
Transfer adapter for reconstitution (1/dose) in the following pack sizes:
Velikosti pakiranja:
- pack size of 1 glass container of powder plus 1 oral applicator of solvent
- pakiranje z 1 stekleničko s praškom in 1 peroralnim aplikatorjem z vehiklom;
- pack size of 5 glass containers of powder plus 5 oral applicators of solvent
- pakiranje s 5 stekleničkami s praškom in 5 peroralnimi aplikatorji z vehiklom;
- pack size of 10 glass containers of powder plus 10 oral applicators of solvent
- pakiranje z 10 stekleničkami s praškom in 10 peroralnimi aplikatorji z vehiklom;
- pack size of 25 glass containers of powder plus 25 oral applicators of solvent
- pakiranje s 25 stekleničkami s praškom in 25 peroralnimi aplikatorji z vehiklom.
The solvent should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to reconstitution.
Pred rekonstitucijo morate preveriti videz vehikla glede morebitne prisotnosti kakršnih koli tujih delcev in/ ali neobičajnega fizikalnega videza, in sicer tako preden ga pretresete kot tudi potem, ko ste ga pretresli.
The reconstituted vaccine should also be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Pred aplikacijo morate preveriti tudi videz rekonstituiranega cepiva glede morebitne prisotnosti kakršnih koli tujih delcev in/ ali neobičajnega fizikalnega videza.
Remove the plastic cover from the glass container containing the powder.
S stekleničke s praškom odstranite plastični pokrovček.
Connect the transfer adapter onto the glass container by pushing it downwards until the transfer adapter is properly and securely placed.
Prepričajte se, da je dobro in zanesljivo nameščen.
The shaken suspension will appear as a turbid liquid with a slow settling white deposit.
Pretresena suspenzija je motna tekočina s počasi usedajočo se belo usedlino.
Connect the oral applicator into the transfer adapter by pushing it firmly on this device.
Peroralni aplikator nastavite na nastavek za prenos in ga s pritiskom dobro pritrdite.
Transfer the entire content of the oral applicator into the glass container containing the powder.
Celotno vsebino peroralnega aplikatorja iztisnite v stekleničko s praškom.
With the oral applicator still attached, shake the glass container and examine it for complete suspension of the powder.
Prepričajte se, da se je prašek popolnoma raztopil.
This appearance is normal.
Takšen videz je normalen.
Withdraw the entire mixture back into the oral applicator.
Celotno vsebino rekonstituiranega cepiva potegnite nazaj v peroralni aplikator.
Remove the oral applicator from the transfer adapter.
Peroralni aplikator odstranite iz nastavka za prenos.
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).
Do not inject.
Ne injicirajte!
Oral applicator Tip-Cap
Zaščitni pokrovček peroralnega 3.
1.
Na stekleničko nastavite 1.
Remove the plastic cover from the glass container containing the powder
S stekleničke s praškom odstranite aplikatorja dobro pretresite.
Shake the oral applicator containing the solvent vigorously.
Pretresena nastavek za prenos in ga pritisnite plastični pokrovček. suspenzija je motna tekočina s nanj.
The shaken suspension will appear as a turbid liquid with a slow settling white deposit
Prepričajte se, da je dobro in počasi usedajočo se belo usedlino. zanesljivo nameščen.
4.
Peroralni aplikator pustite pritrjen in 4.
Remove the protective tip cap from the oral applicator
S peroralnega aplikatorja
Connect the oral applicator into the transfer adapter by pushing it firmly on this device
Peroralni aplikator nastavite na
Transfer the entire content of the oral applicator into the glass container containing the powder
Celotno vsebino peroralnega
With the oral applicator still attached, shake the glass container and examine it for complete suspension of the powder.
Prepričajte se,
The reconstituted vaccine will appear more turbid than the solvent alone.
odstranite zaščitni pokrovček.
This appearance is normal
nastavek za prenos in ga s
Withdraw the entire mixture back into the oral applicator
pritiskom dobro pritrdite.
9.
praškom.
Remove the oral applicator from the transfer adapter
Rekonstituirano cepivo je bolj motno kot sam vehikel.
This vaccine is for oral administration only.
To cepivo je namenjeno izključno 8.
The child should be seated in a reclining position.
Peroralni aplikator odstranite iz
Administer the entire content of the oral applicator orally (by administering the entire content of the oral applicator on the inside of the cheek)
Otroka
Do
Ne injicirajte.
not inject.
nastavka za prenos.
1 dose (1.5ml) contains:
En odmerek (1, 5 ml) vsebuje:
This product contains sucrose 1073 mg (see section 4.4).
Cepivo vsebuje 1. 073 mg saharoze (glejte poglavje 4. 4).
Method of administration
3 Način uporabe
12 Rotarix is for oral use only.
Cepivo Rotarix je namenjeno izključno za peroralno uporabo.
Viral antigen particles detected by ELISA were found in 50% of stools after the first dose of Rotarix lyophilised formulation and 4% of stools after the second dose.
Po aplikaciji prvega odmerka liofilizirane oblike cepiva Rotarix so s testom ELISA odkrili virusne antigene v 50% vzorcev blata, po aplikaciji drugega odmerka cepiva pa v 4% vzorcev blata.
13 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.
4 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.
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.
14 • Clinical trials for the lyophilised formulation
• Klinična preskušanja liofilizirane oblike cepiva
In a total of eleven placebo-controlled clinical trials, approximately 77800 doses of Rotarix lyophilised formulation were administered to approximately 40200 infants.
Izvedenih je bilo enajst s placebom nadzorovanih kliničnih preskušanj, v katerih je približno 40200 otrok prejelo približno 77800 odmerkov liofilizirane oblike cepiva Rotarix.
In two clinical trials (Finland), Rotarix lyophilised formulation was administered alone (administration of routine paediatric vaccines was staggered).
V dveh kliničnih preskušanjih (Finska) so otroci prejeli samo liofilizirano obliko cepiva Rotarix (rutinsko cepljenje z drugimi cepivi je bilo odloženo).
In the remaining nine trials (Europe, Canada, USA, Latin America, Singapore, South-Africa), Rotarix lyophilised formulation was co-administered with routine paediatric vaccines (see section 4.5).
V preostalih devetih preskušanjih (Evropa, Kanada, Združene države Amerike, Latinska Amerika, Singapur, Južna Afrika) so otroci sočasno z liofilizirano obliko cepiva Rotarix prejeli tudi druga rutinska cepiva (glejte poglavje 4. 5).
Very common (≥1/10) Common (≥1/100, < 1/10) Uncommon (≥1/1,000, < 1/100) Rare (≥1/10,000, < 1/1,000)
Zelo pogosti (≥ 1/ 10) Pogosti (≥ 1/ 100, < 1/ 10) Občasni (≥ 1/ 1. 000, < 1/ 100) Redki (≥ 1/ 10. 000, < 1/ 1. 000)
Infections and infestations Rare: upper respiratory tract infection
Infekcijske in parazitske bolezni Redki: okužba zgornjih dihalnih poti
General disorders and administration site conditions Common: fever, fatigue
Splošne težave in spremembe na mestu aplikacije Pogosti: povišana telesna temperatura, utrujenost
15 Intussusception within 31 days after administration of:
Invaginacija v 31 dneh po
First dose Second dose *CI: confidence interval
prvega odmerka drugega odmerka
1 5
1 2 5 5
2 5
0, 50 (0, 07; 3, 80) 0, 99 (0, 31; 3, 21)
0.50 (0.07;3.80) 0.99 (0.31;3.21)
* IZ: interval zaupanja (CI – » confidential interval «)
• Post marketing surveillance for the lyophilised formulation:
• Spremljanje liofilizirane oblike cepiva po pridobitvi dovoljenja za promet:
• Clinical trials for the liquid formulation
• Klinična preskušanja tekoče oblike cepiva
In a total of four clinical trials, approximately 3800 doses of Rotarix liquid formulation were administered to approximately 1930 infants.
Izvedena so bila štiri klinična preskušanja, v katerih je približno 1. 930 otrok prejelo 3. 800 odmerkov tekoče oblike cepiva Rotarix.
Those trials have shown that the safety and reactogenicity profile of the liquid formulation is comparable to the lyophilised formulation.
Ta preskušanja so pokazala, da je profil varnosti in neželenih učinkov tekoče oblike cepiva primerljiv s profilom liofilizirane oblike cepiva.
Protective efficacy of the lyophilised formulation
Učinkovitost zaščite liofilizirane oblike cepiva
After two doses of Rotarix, the protective vaccine efficacy observed during the first and second year of life is presented in the following table:
7 V spodnji tabeli je prikazana učinkovitost zaščite cepiva med prvim in drugim letom življenja po aplikaciji dveh odmerkov cepiva Rotarix:
1st year of life
Hud †
2nd year of life
Hud †
Rotarix N=2572;
Serotip
Rotarix N=2554;
Katerakoli jakost
Placebo N=1302 (§)
Katerakoli jakost
Placebo N=1294 (§)
G1P[ 8]
G4P[8]
Sevi s P[ 8]
16
genotipom
G9P[8]
Krožeči sevi
[51.1;88.5]
rotavirusov