natgillin/translations-raw huggingface dataset:
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 «) Vehikel: kalcijev karbonat, ksantanski gumi, voda za injekcije
Rotarix is supplied as a whitish powder in a single dose glass container and a separate oral applicator of solvent which contains a slow settling white deposit and a colourless supernatant.
Cepivo Rotarix je na voljo v enoodmerni steklenički z belkastim praškom in ločeno z vehiklom napolnjenim peroralnem aplikatorju, ki vsebuje počasi usedajočo se belo usedlino in brezbarven supernatant.
Both components must be mixed together before your child receives the vaccine.
Preden bo vaš otrok prejel cepivo je treba obe sestavini zmešati skupaj.
Eesti GlaxoSmithKline Eesti OÜ Tel: +372 667 6900 estonia@gsk.com
Eesti
Österreich GlaxoSmithKline Pharma GmbH.
Österreich
Tel: + 43 1 970 75-0 at .info@gsk.com
46 GlaxoSmithKline Pharma GmbH.
53 Ελλάδα GlaxoSmithKline A.E.B.E Tηλ: + 30 210 68 82 100
GlaxoSmithKline Eesti OÜ Tel: + 43 1 970 75- 0 Tel: +372 667 6900 at. info@ gsk. com estonia@ gsk. com
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu. ------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Podrobne informacije o cepivu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu. ----------------------------------------------------------------------------------------------------------------------------- Naslednje informacije so namenjene samo zdravstvenemu osebju:
A white deposit and clear supernatant is observed upon storage of the oral applicator containing the solvent.
47 Med shranjevanjem se v peroralnem aplikatorju z vehiklom pojavi bela usedlina in bister supernatant.
54 The reconstituted vaccine is slightly more turbid than the solvent and is milky white in appearance.
Rekonstituirano cepivo je nekoliko bolj motno kot vehikel in mlečno belo.
55 Transfer adapter
48 Nastavek za prenos
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 počasi usedajočo se belo usedlin zanesljivo nameščen.
Shake the oral applicator containing the solvent vigorously.
Peroralni aplikator pustite pritrjen in
Transfer the entire content of the oral applicator into the glass container containing the powder
Prepričajte se,
With the oral applicator still attached, shake the glass container and examine it for complete suspension of the powder.
nastavek za prenos in ga s
57 Take special care with Rotarix Inform your doctor/health care professional if your child: • has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system. • has any disorder of the gastrointestinal system. • has not been gaining weight and growing as expected. • was born prematurely, because the level of protection afforded by the vaccine is unknown in this case.
V tem primeru ni znano kakšen nivo zaščite se lahko doseže s cepivom.
The vaccine (1.5 ml liquid) will be given orally.
Otrok bo cepivo (1, 5 ml tekočine) prejel peroralno (skozi usta).
Like all medicines, Rotarix can cause side effects, although not everybody gets them.
Kot vsa cepiva ima lahko tudi cepivo Rotarix neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
Side effects that occurred during clinical trials with Rotarix were as follows:
♦ Zelo pogosti (neželeni učinki, ki se lahko pojavijo pri 1 na 10 odmerkov cepiva ali več):
♦ Very common (These may occur with 1 in 10 doses or more of the vaccine): • loss of appetite • irritability
♦ Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 na 10 odmerkov cepiva):
♦ Common (These may occur with up to 1 in 10 doses of the vaccine): • fever, tiredness • diarrhoea, vomiting, regurgitation of food, flatulence, abdominal pain
povišana telesna temperatura, utrujenost driska, bruhanje, regurgitacija hrane, nabiranje plinov v želodcu in črevesju, bolečine v trebuhu
- The other ingredients in Rotarix are: sucrose, Di-sodium Adipate, Dulbecco’s Modified Eagle
- Pomožne snovi cepiva Rotarix so: saharoza, dinatrijev adipat, Dulbekov spremenjeni nujni medij
59 Medium (DMEM), sterile water
(DMEM – » Dulbecco’ s Modified Eagle Medium «) in voda za injekcije.
Oral suspension in pre-filled oral applicator.
Peroralna suspenzija v napolnjenem peroralnem aplikatorju.
Rotarix is supplied as clear and colourless liquid in a single dose pre-filled oral applicator (1.5 ml).
En napolnjeni peroralni aplikator vsebuje en odmerek (1, 5 ml).
61 Instructions for administration of the vaccine:
Navodila za aplikacijo cepiva:
Administer orally (i.e. into the child’s mouth, towards the inner cheek) the entire content of the oral
Celotno vsebino peroralnega aplikatorja aplicirajte peroralno (tako, da aplicirate celotno vsebino peroralnega aplikatorja na notranjo stran lica).
63 Take special care with Rotarix Inform your doctor/health care professional if your child: • has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system. • has any disorder of the gastrointestinal system. • has not been gaining weight and growing as expected. • was born prematurely, because the level of protection afforded by the vaccine is unknown in this case.
V tem primeru ni znano kakšen nivo zaščite se lahko doseže s cepivom.
65 Medium (DMEM), sterile water
(DMEM – » Dulbecco’ s Modified Eagle Medium «) in voda za injekcije.
Rotarix is supplied as clear and colourless liquid in a single dose squeezable tube (1.5 ml).
Ena stisljiva tuba vsebuje en odmerek (1, 5 ml).
67 Instructions for administration of the vaccine:
Navodila za aplikacijo cepiva:
Tube tip
Konica tube
RotaTeq is an oral vaccine, presented as a solution in a single dose tube.
Zdravilo RotaTeq je peroralno cepivo v obliki raztopine v enoodmerni tubi.
It contains five live rotavirus strains, each carrying a different antigen (G1, G2, G3, G4 and P1[8]).
Vsebuje pet živih sevov rotavirusov, od katerih ima vsak drugačen antigen (G1, G2, G3, G4 in P1[ 8]).
RotaTeq is a vaccine given to babies from six weeks of age to prevent gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Cepivo RotaTeq dajemo dojenčkom od šest tednov starosti dalje za preprečevanje gastroenteritisa (driske in bruhanja), ki ga povzročijo okužbe z rotavirusi.
RotaTeq is given according to official recommendations.
S cepivom RotaTeq cepimo v skladu z uradnimi priporočili.
RotaTeq is given as three doses, with at least four weeks between each dose.
Cepivo RotaTeq dajemo v treh odmerkih, pri čemer mora biti razmik med vsakih odmerkom vsaj štiri tedne.
The content of the tube of RotaTeq is given directly into the mouth of the baby.
Vsebino tube RotaTeq damo neposredno v usta dojenčka.
The first dose is given when the baby is between six and 12 weeks of age.
S prvim odmerkom cepimo dojenčka pri starosti med šest in 12 tednov.
It is better if the last dose is given before the child is aged 20 to 22 weeks, and in any case, all three doses should have been given by the time the child is 26 weeks (six months) old.
Bolje je, če z zadnjim odmerkom otroka cepimo, preden doseže starost 20 do 22 tednov, v vsakem primeru pa moramo vse tri odmerke dati pred dopolnjenim 26. tednom (šest mesecev).
RotaTeq can be given at the same time as other vaccinations (except the oral polio vaccine, when a two-week interval is needed between administration of the two vaccines).
Cepivo RotaTeq lahko dajemo sočasno z drugimi cepivi (izjema je peroralno cepivo proti otroški ohromelosti (polio), v tem primeru je časovni razmik med cepljenji s tema cepivoma dva tedna).
RotaTeq can be given to premature babies, as long as the pregnancy lasted at least 25 weeks.
Cepivo RotaTeq se lahko daje prezgodaj rojenim otrokom, če je nosečnost trajala vsaj 25 tednov.
The first dose should be given six weeks after birth.
Prvi odmerek je treba dati šest tednov po rojstvu.
An antigen is a specific structure that the body can recognise as ‘ foreign’ and against which it can make an antibody, a special protein that can neutralise or destroy the antigen.
Protitelo je posebna beljakovina, ki lahko nevtralizira ali uniči antigen.
When a child is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these antigens, which help prevent infections caused by rotaviruses that occur naturally that carry the same or very similar antigens.
Ko otroka cepimo, imunski sistem (obrambni sistem proti okužbam) izdela protitelesa proti tem antigenom, s čimer pripomore k preprečevanju okužb, ki jih povzročajo v naravi prisotni rotavirusi z enakimi ali zelo podobnimi antigeni.
Overall, the studies of RotaTeq involved over 72,000 infants, including about 2,000 premature babies.
Učinki zdravila RotaTeq so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged very large (over 70,000 infants) because it was designed to see if the vaccine caused a very rare, serious side effect called intussusception, a condition in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage.
Učinkovitost zdravila so preučili pri skoraj 6000 dojenčkih.
The effectiveness of the vaccine was measured by looking at how many children developed rotavirus gastroenteritis during the following rotavirus season (the time of the year when rotaviruses are known to circulate and cause infection, generally during the cooler months in winter to early spring).
Učinkovitost cepiva je bila izmerjena z ugotavljanjem števila otrok, pri katerih se je v naslednji rotavirusni sezoni (obdobje v letu, ko se pričakuje kroženje rotavirusov in pojav okužb, ponavadi v hladnejših mesecih – od zime do zgodnje pomladi) pojavil rotavirusni gastroenteritis.
82 infants vaccinated with RotaTeq developed rotavirus gastroenteritis (one with severe gastroenteritis) compared to 315 cases among those who received placebo (51 severe cases).
Pri skoraj 6000 dojenčkih, pri katerih so preučevali učinkovitost cepiva, se je število primerov rotavirusnih gastroenteritisov zaradi virusov z enakim antigenom, kot je v cepivu, po cepljenju s cepivom RotaTeq zmanjšalo: rotavirusni gastroenteritis se je pojavil pri 82 dojenčkih (pri enem hud gastroenteritis), ki so bili cepljeni s cepivom RotaTeq, in 315 dojenčkih, ki so prejemali placebo (51 hudih primerov).
The study also showed that, when the children had been vaccinated with RotaTeq, there were fewer hospital admissions or visits to emergency clinics for rotavirus gastroenteritis in vaccinated infants.
Študija je pokazala tudi, da je bilo v skupini otrok, ki so bili cepljeni s cepivom RotaTeq, manj sprejemov v bolnišnico oziroma obiskov klinik za nujno pomoč zaradi rotavirusnega gastroenteritisa.
During the main study, in which about 35,000 infants received RotaTeq and 35,000 received placebo, six infants developed intussusception in the 42 days following a dose of RotaTeq, compared to five who developed the disease after receiving a placebo vaccine.
V glavni študiji, v kateri je približno 35. 000 dojenčkov prejelo cepivo RotaTeq, 35. 000 pa placebo se je pri šestih dojenčkih pojavilo uvihanje črevesja v 42 dneh po odmerku cepiva RotaTeq v primerjavi s petimi dojenčki, pri katerih se je ta bolezen pojavila po prejemu placebo cepiva.
The most common side effects (seen in more than 1 patient in 10) were pyrexia (fever), diarrhoea and vomiting.
Najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) so bili pireksija (zvišana telesna temperatura), driska in bruhanje.
For the full list of all side effects reported with RotaTeq, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila RotaTeq, glejte navodilo za uporabo.
RotaTeq should not be used in infants who may be hypersensitive (allergic) to the active substance or any of the other ingredients, or who have shown signs of allergy after receiving a dose of RotaTeq or another vaccine against rotavirus.
Cepivo RotaTeq se ne sme uporabiti pri dojenčkih, ki utegnejo biti preobčutljivi za (alergični na) zdravilno učinkovino ali katero koli drugo sestavino zdravila, in dojenčkih, ki so kazali znake alergije po prejemu odmerka cepiva RotaTeq ali drugega cepiva proti rotavirusom.
RotaTeq should not be given to infants who have had intussusception in the past or who have problems with their bowel that could predispose them to the disease, or in infants whose immune system is weakened.
Cepivo RotaTeq se ne sme uporabiti pri dojenčkih, ki so imeli uvihanje črevesja v preteklosti, pri dojenčkih, ki imajo težave s črevesjem, ki lahko pomenijo nagnjenost k tej bolezni, in pri dojenčkih, katerih imunski sistem je oslabljen.
As for all vaccines, if RotaTeq is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Tako kot pri vseh cepivih, obstaja tudi pri cepivu RotaTeq tveganje za razvoj apneje (kratki premori med dihanjem), če se daje prezgodaj rojenim otrokom.
Their breathing should be monitored for up to three days after vaccination.
Njihovo dihanje je treba nadzorovati do tri dni po dajanju cepiva
The Committee for Medicinal Products for Human Use (CHMP) concluded that the studies carried out had shown that RotaTeq protects against rotavirus gastroenteritis due to specific types of the virus.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da so študije dokazale zaščitno vlogo cepiva RotaTeq pred rotavirusnim gastroenteritisom, ki ga povzročajo različni tipi virusa.
The possibility of a low risk of intussusception following vaccination, which cannot be ruled out, will be closely monitored after the vaccine is introduced onto the market.
Majhne možnosti uvihanja črevesja po cepljenju ne moremo izključiti, zato se bo to stanje natančno spremljalo po dajanju cepiva v promet.
The Committee decided that RotaTeq’ s benefits are greater than its risks when used in infants from the age of six weeks for the prevention of gastroenteritis due to rotavirus infection.
Odbor je mnenja, da so koristi cepiva RotaTeq večje od z njim povezanih tveganj, če se uporablja za dojenčke od starosti šest tednov dalje za preprečevanje gastroenteritisa, povzročenega z rotavirusi.
The Committee recommended that RotaTeq be given marketing authorisation.
Odbor je za cepivo RotaTeq priporočil odobritev dovoljenja za promet.
Which measures are being taken to ensure the safe use of RotaTeq?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila RotaTeq?
The company that makes RotaTeq will monitor some of the side effects of RotaTeq once it is on the market, particularly the side effects that affect the digestive system.
Proizvajalec cepiva RotaTeq bo nekatere njegove neželene učinke, zlasti neželene učinke, ki vplivajo na prebavila, spremljal potem, ko bo cepivo dano v promet.
The European Commission granted a marketing authorisation valid throughout the European Union for RotaTeq to Sanofi Pasteur MSD, SNC, on 27 June 2006.
Evropska komisija je dovoljenje za promet z zdravilom RotaTeq, veljavno po vsej Evropski uniji, odobrila družbi Sanofi Pasteur MSD, SNC, dne 27. junija 2006.
The full EPAR for RotaTeq can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo RotaTeq je na voljo tukaj.
not less than 2.2 x 106 IU1, 2 not less than 2.8 x 106 IU1, 2 not less than 2.2 x 106 IU1, 2 not less than 2.0 x 106 IU1, 2 not less than 2.3 x 106 IU1, 2
_ * _ En 2- ml odmerek vsebuje: ne manj kot 2, 2 x 106 IE1, 2 G1 serotip * rotavirusa ne manj kot 2, 8 x 106 IE1, 2 G2 serotip * rotavirusa ne manj kot 2, 2 x 106 IE1, 2 G3 serotip * rotavirusa ne manj kot 2, 0 x 106 IE1, 2 G4 serotip * rotavirusa ne manj kot 2, 3 x 106 IE1, 2 P1[ 8] serotip * rotavirusa
1 Infectious Units 2 As lower confidence limit (p = 0.95)
* prerazporejeni humano- bovini rotavirusi (živi), pridobljeni na celicah Vero 1 Infektivnih enot 2 Kot spodnja meja zaupanja (p = 0, 95)
RotaTeq, oral solution
RotaTeq peroralna raztopina
Rotavirus vaccine (live, oral)
cepivo proti rotavirusom (živo, peroralno)
not less than 2.2 x 106 IU1, 2 not less than 2.8 x 106 IU1, 2 not less than 2.2 x 106 IU1, 2 not less than 2.0 x 106 IU1, 2 not less than 2.3 x 106 IU1, 2
En 2- ml odmerek vsebuje: ne manj kot 2, 2 x 106 i. e. 1, 2 G1 serotip * rotavirusa ne manj kot 2, 8 x 106 i. e. 1, 2 G2 serotip * rotavirusa ne manj kot 2, 2 x 106 i. e. 1, 2 G3 serotip * rotavirusa ne manj kot 2, 0 x 106 i. e. 1, 2 G4 serotip * rotavirusa ne manj kot 2, 3 x 106 i. e. 1, 2 P1[ 8] serotip * rotavirusa
This product contains sucrose 1080 mg (see section 4.4).
Cepivo vsebuje 1080 mg saharoze (glejte poglavje 4. 4).
Pale yellow clear liquid that may have a pink tint
Bledorumena bistra tekočina, ki ima lahko rožnat odtenek.
RotaTeq is indicated for the active immunisation of infants from the age of 6 weeks for prevention of gastroenteritis due to rotavirus infection (see section 4.2).
Uporabljamo ga za preprečevanje rotavirusnega gastroenteritisa (glejte poglavje 4. 2).
In clinical trials, efficacy was demonstrated against gastroenteritis due to rotavirus of serotypes G1P1[8], G2P[4], G3P1[8], G4P1[8], and G9P1[8].
V kliničnih preskušanjih so dokazali učinkovitost proti gastroenteritisu, ki ga povzročajo rotavirusi serotipov G1P1[ 8], G2P[ 4], G3P1[ 8], G4P1[ 8] in G9P1[ 8].
See sections 4.4 and 5.1.
Glejte poglavji 4. 4 in 5. 1.
The use of RotaTeq should be in accordance with official recommendations.
Cepivo RotaTeq je treba uporabljati v skladu z uradnimi priporočili.
Posology Three doses of RotaTeq should be administered.
Odmerjanje Otrok mora prejeti tri odmerke cepiva RotaTeq.
The first dose may be administered from the age of six weeks and no later than the age of 12 weeks.
Otrok lahko prvi odmerek prejme pri starosti 6 tednov, vendar pa najkasneje pri starosti 12 tednov.
RotaTeq may be given to infants who were born prematurely provided that the period of gestation was at least 25 weeks.
Cepivo Rotateq lahko prejmejo nedonošenčki, ki so bili rojeni najmanj v 25. tednu nosečnosti.
These infants should receive the first dose of RotaTeq at least six weeks after birth.
Ti otroci morajo prvi odmerek cepiva Rotateq prejeti najmanj 6 tednov po rojstvu.
2 There should be intervals of at least 4 weeks between doses.
2 Med cepljenjem s posameznim odmerkom morajo miniti vsaj 4 tedni.
It is preferable that all three doses should be administered before the age of 20-22 weeks.
Zaželeno je, da do starosti 20- 22 tednov cepimo z vsemi tremi odmerki.
All three doses should be given by the age of 26 weeks.
Otrok mora vse tri odmerke cepiva prejeti pred dopolnjenim 26. tednom starosti.
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.
Ker podatki o zamenljivosti cepiva RotaTeq z drugimi cepivi proti rotavirusom niso na voljo, priporočamo, da otrok, ki je pri cepljenju proti rotavirusom prejel prvi odmerek cepiva RotaTeq, prejme tudi naslednje odmerke istega cepiva.
If it is observed or strongly suspected that an incomplete dose has been swallowed (e. g., infant spits or regurgitates the vaccine), a single replacement dose may be given at the same vaccination visit, however, this has not been studied in clinical trials.
Če opazite ali mislite, da otrok ni pogoltnil celega odmerka (npr. če otrok cepivo izpljune ali izbruhne), mu lahko ob istem obisku date en nadomestni odmerek, vendar pa to v kliničnih preskušanjih ni bilo preučeno.
No further doses are recommended after completion of the 3-dose series (see sections 4.4 and 5.1 regarding available information on persistence of protection).
Po cepljenju s tremi odmerki ne priporočamo nobenih nadaljnjih odmerkov (za podatke o trajanju zaščite glejte poglavji 4. 4 in 5. 1).
Method of administration For oral administration only.
Način uporabe Samo za peroralno uporabo.
See section 6.6 for administration instructions.
Za navodila za uporabo glejte poglavje 6. 6.
Subjects with congenital malformation of the gastrointestinal tract that could predispose to intussusception.
Osebe s prirojenimi nepravilnostmi prebavil, ki bi lahko povzročile invaginacijo.
Infants who have known or suspected immunodeficiency.
Dojenčki, s pomanjkljivim imunskim odzivom ali sumom nanj.
However, in the absence of sufficient data, administration of RotaTeq to asymptomatic HIV subjects is not recommended.
Vendar pa v odsotnosti ustreznih podatkov uporabe cepiva RotaTeq pri dojenčkih z asimptomatsko okužbo s HIV ne priporočamo.
No safety or efficacy data are available regarding administration of RotaTeq to immunocompromised infants, infants infected with HIV or infants who have received a blood transfusion or immunoglobulins within 42 days of dosing.
Podatki o varnosti in učinkovitosti cepiva RotaTeq pri otrocih z imunsko pomanjkljivostjo, otrocih, okuženih z virusom HIV, ali otrocih, ki so v 42 dneh pred ali po prejemu odmerka cepiva prejeli transfuzijo krvi ali imunoglobuline, niso na voljo.
In trials, RotaTeq was shed in the stools of 8.9% of vaccine recipients almost exclusively in the week after dose 1 and in only one vaccine recipient (0.3%) after dose 3.
Pri 8, 9% cepljenih oseb je bilo izločanje prisotno skoraj izključno v tednu po prejemu prvega odmerka, po prejemu tretjega odmerka pa le pri eni osebi (0, 3%).
Peak excretion occured within 7 days of dosing.
Izločanje je bilo največje med prvimi sedmimi dnevi po prejemu odmerka.
It is theoretically possible that transmission of vaccine virus may occur to
Vakcinalni virus se teoretično lahko prenese na seronegativne osebe, ki so v stiku z otrokom.
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).
3 osebe z rakavimi obolenji, s kakorkoli drugače oslabljenim imunskim sistemom ali osebe, ki se zdravijo z imunosupresivno obliko zdravljenja) je potrebna previdnost.
In a clinical study, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks.
V kliničnih študijah je cepivo Rotateq prejelo približno 1. 000 nedonošenčkov, rojenih od 25. do 36. tedna nosečnosti.
The first dose was administered from 6 weeks after birth.
Prvi odmerek so prejeli od 6 tedna po rojstvu dalje.
The safety and efficacy of RotaTeq were comparable between this subset of infants and infants born at term.
Varnost in učinkovitost cepiva Rotateq pri nedonošenčkih sta bili primerljivi z varnostjo in učinkovitostjo pri dojenčkh rojenih na rok.
However, 19 of the approximately 1,000 infants were born at a gestational age of 25 to 28 weeks, 55 were born at a gestational age of 29 to 31 weeks and the remainder was born at a gestational age of between 32 and 36 weeks.
V tej študiji je bilo 19 od 1. 000 nedonošenčkov, rojenih od 25. do 28. tedna nosečnosti, 55 je bilo nedonošenčkov, rojenih od 29. do 31. tedna nosečnosti, preostali nedonošenčki pa so bili rojeni od 32. do 36. tedna nosečnosti.
See sections 4.2 and 5.1.
Glejte poglavji 4. 2. in 5. 1.
Safety or efficacy data are not available for infants with active gastrointestinal illnesses (including chronic diarrhoea) or growth retardation.
Podatki o varnosti in učinkovitosti cepiva pri otrocih z aktivno boleznijo prebavil (vključno s kronično drisko) ali otrocih z zavrto rastjo niso na voljo.