natgillin/translations-raw huggingface dataset:
The use of medicines such as repaglinide, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan, glyburide should be avoided on the day of TOOKAD administration and for at least 24 hours after administration. 
Druga zdravila, ki lahko medsebojno delujejo z zdravilom TOOKAD Na dan uporabe zdravila TOOKAD in vsaj 24 ur po uporabi se je treba izogibati zdravilom, kot so repaglinid, atorvastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, bosentan in gliburid.
- You have abnormal blood clotting. 
Preiskave pogosti nenormalno strjevanje krvi14
proctalgia (pain in the anal region), - Problems with bowels (including diarrhoea or occasional soiling), 
- Težave s črevesjem (vključno z drisko ali občasnim uhajanjem blata).
Use in patients on a controlled potassium diet 
Bolniki, ki so na dieti z nadzorovanim vnosom kalija To zdravilo vsebuje kalij.
Table 2 gives baseline characteristics by arm. 
V preglednici 2 so predstavljene izhodiščne značilnosti glede na krak.
White blood cell count increased 
krvavitev v prostati otekanje mod
There could be an additional risk of eye photosensitivity in patients who have received intra-occular anti-VEGF therapy. 
Pri bolnikih, ki so prejemali intraokularno zdravljenje proti vaskularnemu endotelijskemu rastnemu faktorju (VEGF), lahko obstaja dodatno tveganje preobčutljivosti oči na svetlobo.
• Explain the procedure as well as relevant efficacy and safety results of TOOKAD with simple graphics included in the Patient Information Guide. 
• razlago postopka, kot tudi ustreznih rezultatov glede varnosti in učinkovitosti zdravila
Photosensitivity Strong light may cause skin reactions and eye discomfort while TOOKAD is in the blood stream. 
Dokler je zdravilo TOOKAD v krvnem obtoku, lahko močna svetloba povzroča kožne reakcije in nelagodne občutke v očeh.
Number of subjects with 
Število oseb s/z
Eye irritation Photophobia 
Očesne bolezni občasni draženje očesa fotofobija
The study had two co-primary endpoints for TOOKAD-VTP in comparison to AS: - A: The rate of absence of definite cancer based on histology at 24 months, - B: The difference in rate of treatment failure associated with observed progression of disease from low to moderate or higher risk prostate cancer. 
- B: razlika v stopnji neuspešnosti zdravljenja, povezani z opazovanim napredovanjem bolezni od nizko prek zmerno do visoko tveganega raka prostate.
• Patient information guide • Physician guideline 
• smernice za zdravnike.
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora občasni dispneja ob naporu
Dysuria (bladder pain, bladder spasm, hypertonic bladder, urethral spasm, urinary tract pain). 
6 Disurija (bolečina v mehurju, krči mehurja, hipertonični mehur, krči sečnice, bolečina v sečilih).
Antiplatelet agents (medicines that decrease platelet aggregation (stickiness) in the blood and reduce clotting) 
Antikoagulanti (zdravila, ki preprečujejo strjevanje krvi)
See also under “Other medicines and TOOKAD” for photosensitizing medicines. 
Zdravila, ki povzročajo preobčutljivost na svetlobo, si oglejte tudi v poglavju „Druga zdravila in zdravilo TOOKAD“.
NAME OF THE MEDICINAL PRODUCT TOOKAD 366 mg powder for solution for injection padeliporfin 
TOOKAD 366 mg prašek za raztopino za injiciranje padeliporfin
How TOOKAD is stored 
Shranjevanje zdravila TOOKAD
NAME OF THE MEDICINAL PRODUCT TOOKAD 183 mg powder for solution for injection padeliporfin 
TOOKAD 183 mg prašek za raztopino za injiciranje padeliporfin
Adjusted Hazard Ratio (95% CI) = 0.31 (0.20 ; 0.50) ; p value ≤ 0.001 
eRazmerje tveganja (95 % CI) = 4,39 (2,18; 8,83); vrednost p < 0,001 fRazmerje tveganja (95 % CI) = 4,61 (2,60; 8,16); vrednost p < 0,001
- You have a history of a narrowing of the urethra or urinary flow problems. 
- po postopku VTP čutite kakršno koli nenormalno bolečino; - imate anamnezo zoženja sečnice ali težave s pretokom urina;
Rectal haemorrhage (anal haemorrhage). 
- Hematospermija (prisotnost krvi v ejakulatu).
VTP procedure. 
VTP.
Ureteric haemorrhage Urethral haemorrhage Urinary tract disorders 
Bolezni ledvic in sečil zelo pogosti zastajanje urina hematurija disurija6 motnje uriniranja7
TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection padeliporfin 
Navodilo za uporabo TOOKAD 183 mg prašek za raztopino za injiciranje TOOKAD 366 mg prašek za raztopino za injiciranje padeliporfin Za to zdravilo se izvaja dodatno spremljanje varnosti.
Perineal injury, perineal pain and prostatitis 
pogosti prostatitis bolečina v spolovilih11 bolečina v prostati12
Progression to Gleason ≥ 4 49 (23.8) Number of subjects progressed in the treated lobe* at Month 24, n (%) 
B: Razlika v stopnji neuspešnosti zdravljenja, povezani z opazovanim napredovanjem bolezni Število oseb, pri katerih je bolezen v 24. mesecu napredovala, n (%)
6.6 Special precautions for disposal and other handling 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Priprava raztopine mora potekati v okolju s pridušeno svetlobo.
Perineal pain (pelvic pain). 
- Učinkovina je padeliporfin.
Groin pain Muscle haemorrhage Haemarthrosis Musculoskeletal pain Pain in extremity 
Bolezni mišičnega sistema in vezivnega tkiva pogosti bolečine v hrbtu občasni bolečina v dimljah krvavitev v mišici hemartroza bolečina v mišično-skeletnem sistemu bolečina v udu
The median time to onset of genito-urinary infections was 22.5 days (4-360). 
Srednja vrednost časa do nastopa okužbe sečil in spolovil je znašala 22,5
PHARMACEUTICAL FORM Powder for solution for injection. 
FARMACEVTSKA OBLIKA prašek za raztopino za injiciranje Prašek je liofilizat temne barve.
Adjusted Hazard Ratio (95% CI) = 0.11 (0.05 ; 0.25) ; p value ≤ 0.001 
39 (50,0)j gPrilagojeno razmerje tveganja (95 % CI) = 0,34 (0,24; 0,46); vrednost p ≤ 0,001 hPrilagojeno razmerje tveganja (95 % CI) = 0,31 (0,20; 0,50); vrednost p ≤ 0,001 iPrilagojeno razmerje tveganja (95 % CI) = 0,17 (0,12; 0,27); vrednost p ≤ 0,001 Prilagojeno razmerje tveganja (95 % CI) = 0,11 (0,05; 0,25); vrednost p ≤ 0,001
Haematoma Hypertension 
Žilne bolezni pogosti hematom hipertenzija
In general, the dose of TOOKAD contains less than 1 mmol (39 mg) potassium, i.e. essentially ‘potassium free'. 
(39 mg) kalija, kar v bistvu pomeni, da je pravzaprav „brez kalija“.
TOOKAD is indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and: - Clinical stage T1c or T2a, - Gleason Score ≤ 6, based on high-resolution biopsy strategies, - PSA ≤ 10 ng/mL, - 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm 
- trije pozitivni stebrički rakastega tkiva z najdaljšo dolžino stebrička rakastega tkiva 5 mm v katerem koli stebričku ali 1-2 pozitivna stebrička rakastega tkiva s prisotnostjo rakastega tkiva, ki je v katerem koli stebričku ≥ 50 % v kateremkoli stebričku, ali gostota PSA ≥ 0,15
How TOOKAD is stored Contents of the pack and other information 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo TOOKAD
This appearance is normal 
Takšen videz je normalen.
(cases/controls) 
(primeri/kontrole)
America; 11 countries 
Latinska Amerika; 11 držav
* Because these events were reported spontaneously, it is not possible to reliably estimate their frequency. 
* Ker so bili ti dogodki poročani spontano, njihove pogostnosti ni mogoče zanesljivo oceniti.
Sustained efficacy up to 3 years of age in Asia 
Dolgotrajna učinkovitost do 3. leta starosti v Aziji
Bond et al. (2018) suggested some noncompliance to such recommendation in a recent conference abstract. 
Bond et al. (2018) navaja nekatera neskladja s tem priporočilom v nedavnem abstraktu za konferenco.
not less than 106.0 CCID50 
ne manj kot 106,0 CCID50
These data should be interpreted with caution. 
Te podatke je treba interpretirati previdno.
There is limited evidence of a smaller increased risk following the second dose. 
Malo je dokazov o manjšem povečanju tveganja po drugem odmerku.
(5) Vaccine effectiveness was calculated using neighborhood controls. 
(5) Učinkovitost cepiva je bila izračunana z uporabo kontrol iz soseščine.
Impact on hospitalisation§ 
Vpliv na hospitalizacije§
10, 14 weeks and 6, 10, 14 weeks (Pooled) 
10, 14 teden in 6, 10, 14 teden (združeno)
Date of latest renewal: 14 January 2016 
Datum zadnjega podaljšanja: 14. januar 2016
Vaccine effectiveness estimate is based on 41 fully vaccinated cases and 175 fully vaccinated controls. 
Ocena učinkovitosti cepiva temelji na 41 v celoti cepljenih primerih in 175 v celoti cepljenih kontrol.
50 tubes 
50 tub
All of these strains are circulating worldwide. 
Vsi ti sevi krožijo po celem svetu.
If the reconstituted vaccine is not used within 24 hours, it should be discarded. 
Če se rekonstituirano cepivo ne uporabi v 24 urah, ga je treba zavreči.
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.
Frequencies are reported as: 
Pogostnost je navedena kot:
South Africa, Malawi 
Južnoafriška republika, Malavi
*Produced on Vero cells 
*Pridobljen na Vero celicah
These strains are circulating worldwide. 
Ti sevi krožijo po celem svetu.
No point estimate was available for the remaining study. 
Za preostale študije ocenjene vrednosti niso na voljo.
Impact on mortality§ 
Vpliv na umrljivost§
• You do not need to twist. 
• Ni vam treba vrteti.
This was supported by a very short time-to-onset (from immediate onset to a few hours), the absence of coadministered vaccines or drugs, and the rapid resolution of the event, with or without treatment. 
To podpira zelo kratek čas do nastanka (od takojšnjega nastanka do nekaj ur), odsotnost sočasno danih cepiv ali zdravil in hitra rešitev dogodka, z ali brez zdravljenja.
(1) The number of fully vaccinated (2 doses) and unvaccinated cases and controls is given. 
(1) Navedeno je število v celoti cepljenih (2 odmerka) in necepljenih primerov in kontrol.
Clinical studies from which efficacy data were derived were conducted in Europe, Central and South America, Africa and Asia (see section 5.1). 
Klinične študije, na katerih temeljijo podatki o učinkovitosti, so bile izvedene v Evropi, Centralni ter Južni Ameriki, Afriki in Aziji (glejte poglavje 5.1).
Rotavirus infection is the most common cause of severe diarrhoea in infants and young children. 
Okužba z rotavirusi je najpogostejši vzrok hude driske pri dojenčkih in mlajših otrocih.
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.
A minor infection such as a cold should not be a problem, but talk to your doctor first. 
Blažja okužba, kot je npr. prehlad, ne bi smela biti težava, vendar se pred cepljenjem vseeno pogovorite z zdravnikom;
The incidence of severe RV gastro-enteritis associated with the individual genotypes was too small to allow calculation of efficacy. 
Incidenca hudega RV gastroenteritisa, povezanega s posameznimi genotipi, je bila premajhna, da bi dopuščala izračun učinkovitosti.
• Turn the cap upside down (180°). 
• Obrnite zaporko na glavo (180°).
• if your child has previously had any allergic reaction to rotavirus vaccines or any of the other ingredients of this vaccine (listed in section 6). 
• če je predhodno imel kakršnokoli alergijsko reakcijo na cepiva proti rotavirusom ali katerokoli sestavino tega cepiva (navedeno v poglavju 6).
Tell your doctor if your child is taking, has recently taken or might take any other medicines or has recently received any other vaccine. 
Obvestite svojega zdravnika, če vaš otrok jemlje, je pred kratkim jemal ali pa bo morda začel jemati katerokoli drugo zdravilo, ali če je bil pred kratkim cepljen s katerimkoli cepivom.
Some cases of overdose have been reported. 
Poročali so o nekaj primerih prevelikega odmerjanja.
Natural fluctuations of the incidence of the disease may also influence the observed temporal effect. 
Na opaženi časovni učinek lahko vpliva tudi naravno nihanje incidence bolezni.
g) Pull it from the connecting bar. 
g) Povlecite jo od povezovalne ploščice.
If not used immediately, in-use storage should not be longer than 24 hours and at a temperature between 2-25°C. 
čas shranjevanja med uporabo ne sme presegati 24 ur pri temperaturi od 2°C do 25 °C.
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) 
Pogosti (≥ 1/100 do < 1/10) Občasni (≥ 1/1.000 do < 1/100) Redki (≥ 1/10.000 do < 1/1.000) Zelo redki (< 1/10.000)
Oral suspension 1 tube 
peroralna suspenzija 1 tuba
This is so that the unused oral tubes can be used for the next vaccination. 
To morate narediti zato, da lahko neporabljene tube uporabite za naslednje cepljenje.
Other special populations 
Posebne populacije
Your child will receive two doses of the vaccine. 
Otrok bo prejel dva odmerka cepiva.
No cases of intussusception were reported. 
Opisan ni bil noben primer invaginacije.
All RVGE 
Vsi RVGE
Do not hold the body of the oral tube, you may squeeze out some of the vaccine. 
Ne držite telesa tube, saj lahko iz nje iztisnete nekaj cepiva.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 February 2006 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. februar 2006
Schedule Studies conducted in 
Študije izvedene v
• If the membrane has not been pierced return to section B and repeat steps 2, 3 and 4. 
Kaj narediti, če membrana ni prebodena • Če membrana ni prebodena, se vrnite na točko B in ponovite korake 2,3 in 4.
Abdominal pain, flatulence 
Občasni abdominalna bolečina, flatulenca
Similar studies in Armenia, Australia, Brazil, Canada, El Salvador and Zambia showed a reduction of 45 to 93% between 2 and 4 years after vaccine introduction. 
Podobne študije v Armeniji, Avstraliji, Braziliji, Kanadi, El Salvadorju in Zambiji so pokazale zmanjšanja od 45 % do 93 % dve do štiri leta po uvedbi cepiva.
e) Hold the tab of the separated oral tube in one hand and the connecting bar in the other hand. 
e) Držite dno ločene tube v eni roki in povezovalno ploščico v drugi.
To separate one oral tube from the others starting at one end: a) Hold the tab of one of the end oral tubes to separate it from the others. 
Za ločitev ene tube od ostalih, začnite na enem koncu: a) Primite dno ene od krajnih tub, da jo ločite od ostalih.
The vaccine is to be administered orally without mixing with any other vaccines or solutions. 
Cepivo je treba aplicirati peroralno brez mešanja z drugimi cepivi ali raztopinami.
• Provide, on a 6-month basis, updates on the progress being made on the activities set out in the implementation plan for the development of a PCV-free vaccine, as agreed by CHMP on 15 September 2016: every June and December until the PCV-free Rotarix application. 
• vsakih 6 mesecev predal posodobljene informacije o doseženem napredku pri dejavnostih, določenih v implementacijskem načrtu za razvoj cepiva brez PCV, kot je bilo dogovorjeno z odborom CHMP 15. septembra 2016: vsak junij in december, do oddaje vloge za cepivo brez PCV;
It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on longer periods of follow-up (see section 4.4). 
Nepojasnjeno ostaja, ali cepiva proti rotavirusom vplivajo na celotno pogostnost invaginacije pri daljših obdobjih spremljanja (glejte poglavje 4.4).
High Income countries 
Države z visokim prihodkom
Severity of gastro-enteritis (GE) was defined according to WHO criteria. 
Resnost gastroenteritisa (GE) je bila definirana po kriterijih Svetovne zdravstvene organizacije.
Check that each individual oral tube is not damaged and is still sealed. 
Preverite, da nobena posamezna tuba ni poškodovana in je še vedno zapečatena.
• There is a small spike inside the top of the cap - in the centre. 
• V notranjosti vrha zaporke je majhna konica - v sredini.
• Give the vaccine straight away. 
• Cepivo uporabite takoj.
C Check the tube has opened correctly 1. 
C Preverite, da ste tubo pravilno odprli 1.
• he/she has any disease or is taking any medicine which reduces his/her resistance to infection or if his/her mother has taken during pregnancy any medicine that may weaken the immune system. 
• ima otrok katerokoli bolezen ali jemlje katerokoli zdravilo, ki zmanjšuje njegovo odpornost na okužbe ali je njegova mati med nosečnostjo jemala katerokoli zdravilo, ki lahko oslabi imunski sistem.
- Pre-filled oral applicator: 3 years 
- Napolnjen peroralni aplikator: 3 leta
Rotarix should not be used in children over 24 weeks of age. 
Cepivo Rotarix se ne sme uporabljati pri otrocih, starejših od 24 tednov.
3, 5 months Finland, Italy 180 
Finska, Italija 180
• There should be a hole at the top of the tube. 
• Na vrhu tube mora biti luknjica.
• Check the tube has not been damaged nor is already open. 
• Preverite, da tuba ni poškodovana ali že odprta.
• Very rare: hives (urticaria) 
• zelo redki: koprivnica (urtikarija)
A clinical study in a limited number of asymptomatic or mildly symptomatic HIV positive infants showed no apparent safety problems (see section 4.8). 
Klinična študija pri majhnem številu asimptomatskih ali blago simptomatskih HIV-pozitivnih dojenčkov ni pokazala očitnih težav z varnostjo (glejte poglavje 4.8).
Unused oral tubes that are still attached to the connecting bar must be put back in the fridge immediately after an oral tube has been used. 
Neporabljene tube, ki so še vedno pritrjene na povezovalno ploščico, morate shraniti nazaj v hladilnik takoj po tem, ko ste eno tubo porabili.
• Keep the cap - you need this to pierce the membrane. 
• Zaporko obdržite - potrebujete jo, da boste prebodli membrano.
• inflammation of the skin 
• napihnjenost • vnetje kože
• Squeeze the liquid gently into the side of the child's mouth - towards the inside of their cheek. 
• Nežno stisnite tekočino na stran otrokovih ust - proti notranjosti lica.
• It is ready to use - you do not need to mix it with anything. 
• Cepivo je pripravljeno za uporabo - ni vam ga treba zmešati z ničemer.
Safety in infants with human immunodeficiency (HIV) infection 
Varnost pri dojenčkih, okuženih s HIV (virusom humane imunske pomanjkljivosti)
Expiry date: DD/MM/YY 
Rok uporabnosti: : DD/MM/YY
In order to address the presence of porcine circovirus type 1(PCV-1) in Rotarix, the MAH commits to: 
Z namenom obravnavanja prisotnosti prašičjega cirkovirusa tipa 1 (PCV-1) v cepivu Rotarix, se imetnik DzP zavezuje, da bo:
• One oral tube delivers one dose of vaccine. 
• Ena tuba vsebuje en odmerek cepiva.
Rotarix should under no circumstances be injected. 
Cepiva Rotarix se v nobenem primeru ne sme injicirati.
Subjects with Severe Combined Immunodeficiency (SCID) disorder (see section 4.8). 
Osebe s hudo kombinirano imunsko pomanjkljivostjo (SCID) (glejte poglavje 4.8).
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine. 
Bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo prejeti tega cepiva.
In addition, nine impact studies on all-cause diarrhoea hospitalisation conducted in Africa and Latin America showed a reduction of 14% to 57% between 2 and 5 years after vaccine introduction. 
Poleg tega je devet študij vpliva na hospitalizacije zaradi driske zaradi vseh vzrokov, izvedenih v Afriki in Latinski Ameriki, pokazalo zmanjšanje od 14 % do 57 % dve do pet let po uvedbi cepiva.
The presence of a minor infection is not a contra-indication for immunisation. 
Blage okužbe niso kontraindikacija za cepljenje.
Countries Period 
Država Obdobje
Parents/guardians should be advised to promptly report such symptoms to their healthcare provider. 
Staršem oz. skrbnikom je potrebno svetovati, da o takšnih simptomih nemudoma poročajo zdravniku.
Administer the entire content of the oral applicator orally (by administering the entire content of the oral applicator on the inside of the cheek) 
Celotno vsebino peroralnega aplikatorja aplicirajte peroralno (tako, da aplicirate celotno vsebino peroralnega aplikatorja na notranjo stran lica).
It might be necessary to postpone the vaccination until recovery. 
Cepljenje bo morda treba odložiti, dokler ne bo ozdravel.
(6) In subjects who did not receive the full course of vaccination, the effectiveness after one dose ranged from 
(6) Med preiskovanci, ki niso prejeli celotnega zaporedja cepljenja, je bila učinkovitost po enem odmerku v razponu od
Data from observational safety studies performed in several countries indicate that rotavirus vaccines carry an increased risk of intussusception, mostly within 7 days of vaccination. 
Invaginacija Podatki iz opazovalnih študij varnosti, opravljenih v več državah, kažejo, da cepiva proti rotavirusom spremlja povečano tveganje za invaginacijo, večinoma v 7 dneh po cepljenju.
It is good clinical practice that vaccination should be preceded by a review of the medical history especially with regard to the contraindications and by a clinical examination. 
V skladu z dobro klinično prakso se je pred cepljenjem treba seznaniti z anamnezo, še posebej v povezavi z morebitnimi kontraindikacijami in opraviti klinični pregled.
D Give the vaccine 
D Dajanje cepiva
If you notice anything abnormal, do not use the vaccine. 
Če opazite karkoli nenormalnega, ne uporabite cepiva.
It is important that you follow the instructions of your doctor or nurse regarding return visits. 
Pomembno je, da natančno upoštevate navodila zdravnika ali drugega zdravstvenega osebja glede ponovnega obiska zaradi cepljenja s tem cepivom.
Up to 6 additional cases per 100,000 infants have been observed in these countries against a background incidence of 25 to 101 per 100,000 infants (less than one year of age) per year, respectively. 
V teh državah so ugotovili do 6 dodatnih primerov na 100.000 dojenčkov v primerjavi z osnovno incidenco od 25 do 101 na 100.000 dojenčkov (mlajših od enega leta starosti) na leto.
• Submit an application at the latest in 2020 to amend the particulars of the marketing authorisation in order to render the medicinal product PCV-free. 
• najkasneje do leta 2020 oddal vlogo za spremembo dovoljenja za promet, da bo zagotovil cepivo brez PCV.
* Not statistically significant (p ≥0.05). 
* Ni statistično značilno (p ≥ 0,05).
• This vaccine is given orally - straight from the tube. 
• To cepivo se daje peroralno - neposredno iz tube.
The vaccine should be used immediately after opening. 
Cepivo je treba uporabiti takoj po odprtju vsebnika.
The child should be seated in a reclining position. 
Otroka morate namestiti v pokončen položaj.
Contacts of recent vaccinees should observe personal hygiene (e.g. wash their hands after changing child's nappies). 
Osebe, ki so v stiku s pred kratkim cepljenim otrokom, morajo poskrbeti za ustrezno osebno higieno (npr. umivanje rok po menjavi plenic).
Rotarix is not intended for use in adults. 
Cepivo Rotarix ni namenjeno za uporabo pri odraslih.
Contact a doctor/health care professional right away if your child experiences one of these symptoms. 
Nemudoma se posvetujte z zdravnikom ali drugim zdravstvenim osebjem, če se pri vašem otroku pojavi kateri izmed teh simptomov.
Other medicines and Rotarix 
Druga zdravila in cepivo Rotarix
Effectiveness after 2 doses in preventing RVGE leading to hospitalization 
Učinkovitost po 2 odmerkih za preprečevanje RVGE, ki povzroči sprejem v bolnišnico
Do not inject! 
Ne injicirajte!
Serious adverse events were observed in 5.1% of recipients of Rotarix as compared with 6.8% of placebo recipients. 
Resne neželene učinke so opazili pri 5,1 % otrok, ki so dobili cepivo Rotarix, in pri 6,8 % tistih, ki so dobili placebo.
The vaccine is ready to use (no reconstitution or dilution is required). 
Cepivo je že pripravljeno za uporabo (brez rekonstitucije ali nadaljnjega redčenja).