natgillin/translations-raw huggingface dataset:
After your child has received Rotarix, contact a doctor/health care professional right away if your child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever (see also section 4 “Possible side effects”).
Če se otroku, ki je dobil cepivo Rotarix, pojavijo hude bolečine v trebuhu, dolgotrajno bruhanje, kri v blatu, napihnjen trebuh in/ali močno zvišana telesna temperatura, se morate nemudoma posvetovati z zdravnikom ali drugim zdravstvenim osebjem (glejte tudi poglavje 4 »Možni neželeni učinki«).
C. Give the vaccine orally immediately after opening
C. Cepivo dajte peroralno takoj po odprtju tube 1.
Since the immune response observed after 2 doses of Rotarix liquid formulation was comparable to the immune response observed after 2 doses of Rotarix lyophilised formulation, the levels of vaccine efficacy observed with the lyophilised formulation can be extrapolated to the liquid formulation.
Ker je imunski odziv, opažen po aplikaciji 2 odmerkov tekoče oblike cepiva Rotarix, primerljiv z imunskim odzivom po aplikaciji 2 odmerkov liofilizirane oblike cepiva Rotarix, lahko domnevamo, da je učinkovitost zaščite tekoče oblike enaka učinkovitosti zaščite liofilizirane oblike.
The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration.
Cepivo je bistra in brezbarvna tekočina brez vidnih delcev za peroralno uporabo.
Strains with P[8] genotype † Severe rotavirus gastro-enteritis was defined as an episode of diarrhoea with or without vomiting that required hospitalization and/or re-hydration therapy in a medical facility (WHO criteria) * Not statistically significant (p ≥ 0.05).
Sevi z genotipom P[8] † Hud rotavirusni gastroenteritis je bil opredeljen kot obdobje driske (z bruhanjem ali brez njega), ki je zahtevalo sprejem v bolnišnico in/ali rehidracijsko zdravljenje v zdravstveni ustanovi (merila Svetovne zdravstvene organizacije).
In a clinical study, 670 pre-term infants from 27 to 36 weeks of gestational age were administered Rotarix and 339 received placebo.
V klinični študiji je 670 nedonošenčkov z gestacijsko starostjo od 27 do 36 tednov dobilo cepivo Rotarix, 339 pa placebo.
B Get the tube ready
B Priprava tube
Severe rotavirus gastroenteritis† (1st year of life) Rotarix N=9,009 Placebo N=8,858
Hud rotavirusni gastroenteritis† (prvo leto življenja) Rotarix n = 9.009 Placebo n = 8.858
Similar rates of other adverse events were observed in Rotarix and placebo recipients.
Deleži ostalih neželenih učinkov so bili med prejemniki cepiva Rotarix in placeba podobni.
In a total of twenty-three clinical trials, approximately 106,000 doses of Rotarix (lyophilised or liquid formulation) were administered to approximately 51,000 infants.
Izvedenih je bilo triindvajset kliničnih preskušanj, v katerih je približno 51.000 otrok prejelo približno 106.000 odmerkov cepiva Rotarix (liofilizirana ali tekoča oblika).
A What you need to do before giving Rotarix
A Kaj morate narediti pred dajanjem cepiva Rotarix
1 dose of powder in a glass container (type I glass) with a stopper (rubber butyl) 1 ml of solvent in an oral applicator (type I glass) with a plunger stopper and a protective tip cap (rubber butyl).
1 ml vehikla v peroralnem aplikatorju (steklo tipa I) z batnim zamaškom in zaščitnim pokrovčkom (butilna guma).
In a clinical study, 670 pre-term infants from 27 to 36 weeks of gestational age were administered Rotarix lyophilised formulation and 339 received placebo.
V klinični študiji je 670 nedonošenčkov z gestacijsko starostjo od 27 do 36 tednov dobilo liofilizirano obliko cepiva Rotarix, 339 pa placebo.
How Rotarix is given
Kako se cepivo Rotarix uporablja
See the package leaflet for further information
Za dodatne informacije glejte navodilo za uporabo.
The doctor or nurse will administer the recommended dose of Rotarix to your child.
Priporočeni odmerek cepiva Rotarix bo vašemu otroku dal zdravnik ali medicinska sestra.
EU/1/05/330/005 - pack of 1 pre-filled oral applicator EU/1/05/330/006 - pack of 5 pre-filled oral applicators EU/1/05/330/007 - pack of 10 pre-filled oral applicators EU/1/05/330/008 - pack of 25 pre-filled oral applicators
EU/1/05/330/005 - pakiranje z 1 napolnjenim peroralnim aplikatorjem EU/1/05/330/006 - pakiranje s 5 napolnjenimi peroralnimi aplikatorji EU/1/05/330/007 - pakiranje s 10 napolnjenimi peroralnimi aplikatorji EU/1/05/330/008 - pakiranje s 25 napolnjenimi peroralnimi aplikatorji
In three placebo-controlled clinical trials (Finland, India and Bangladesh), in which Rotarix was administered alone (administration of routine paediatric vaccines was staggered), the incidence and severity of the solicited events (collected 8 days post-vaccination), diarrhoea, vomiting, loss of appetite, fever, irritability and cough/runny nose were not significantly different in the group receiving Rotarix when compared to the group receiving placebo.
V skupini, ki je prejela cepivo Rotarix, se pojavnost in resnost nespontano navedenih učinkov (zbranih 8 dni po cepljenju), driske, bruhanja, izgube apetita, povišane telesne temperature, razdražljivosti in kašlja/izcedka iz nosu ni pomembno razlikovala od pojavnosti v skupini, ki je prejela placebo.
Therefore, breast-feeding may be continued during the vaccination schedule.
Med cepljenjem z obema odmerkoma cepiva se torej lahko nadaljuje z dojenjem.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (1.5 ml)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek (1,5 ml)
Pre-filled oral applicator EU/1/05/330/005
Napolnjen peroralni aplikator EU/1/05/330/005
• in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
• pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti) se lahko v dveh do treh dneh po cepljenju pojavijo med vdihi daljši presledki, kot je normalno • otroci z redko dedno boleznijo, imenovano huda kombinirana imunska pomanjkljivost
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 4,000 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.
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 4,200 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,
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance.
Pred aplikacijo morate preveriti videz cepiva glede morebitne prisotnosti kakršnihkoli tujih delcev in/ali neobičajnega fizikalnega videza.
• Very rare: intussusception (part of the intestine gets blocked or twisted).
• zelo redki: invaginacija (zapora ali zasukanje dela črevesa).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (1 ml)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 odmerek (1 ml)
In observational studies, vaccine effectiveness was demonstrated against severe gastro-enteritis leading to hospitalisation due to rotavirus of common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8] as well as the less common rotavirus genotypes G9P[4] and G9P[6].
V opazovalnih študijah so dokazali učinkovitost cepiva proti hudemu gastroenteritisu, ki zahteva sprejem v bolnišnico in ga povzročajo pogosti rotavirusni genotipi G1P[8], G2P[4], G3P[8], G4P[8] in G9P[8], kot tudi manj pogosta rotavirusna genotipa G9P[4] in G9P[6].
Check the liquid in the oral tubes is clear, colourless and free from any particles.
Preverite, da je tekočina v tubi bistra in brezbarvna ter da v njej ni delcev.
Remove the plastic cover from the glass container containing the powder
S stekleničke s praškom odstranite plastični pokrovček.
b) With your other hand, hold the tab of the oral tube next to it. c) Pull the tab and tear it away from the oral tube next to it.
c) Povlecite dno in ga odtrgajte od sosednje tube.
Remove the protective tip cap from the oral applicator.
S peroralnega aplikatorja odstranite zaščitni pokrovček.
- If you get any side effects, talk to your doctor or pharmacist.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
50 tubes 50 x 1 dose (1.5 ml)
50 tub 50 x 1 odmerek (1,5 ml)
< 4 yrs
< 4 leta
Repeatedly flick the top of the tube until it is clear of any liquid
Večkrat frcnite vrh tube, dokler na njem ni več tekočine • S frcanjem tik pod membrano odstranite vso tekočino iz najtanjšega predela tube.
Rotarix may be given at the same time your child receives other normally recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C conjugate vaccines.
Otrok lahko cepivo Rotarix prejme sočasno z drugimi predpisanimi cepivi, kot so cepivo proti davici, tetanusu in oslovskemu kašlju, cepivo proti hemofilusu influence tipa b, peroralno ali inaktivirano cepivo proti otroški ohromelosti, cepivo proti hepatitisu B, konjugirano cepivo proti pnevmokokom in konjugirano cepivo proti meningokokom serološke skupine C.
Connecting bar
POVEZANE S PLOŠČICO
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Rotarix
IME ZDRAVILA IN POT(I) UPORABE Vehikel za Rotarix peroralna uporaba
Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus infection.
Cepivo vašega otroka, starejšega od 6 tednov, pomaga ščititi pred gastroenteritisom (drisko in bruhanjem), ki ga povzročajo rotavirusi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED ORAL APPLICATOR, PACK SIZE OF 1, 5, 10 OR 25
PODATKI NA ZUNANJI OVOJNINI NAPOLNJENI PERORALNI APLIKATOR, VELIKOST PAKIRANJA 1, 5, 10 ALI 25
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TUBE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH TUBA
8-11 m
8-11 mesecev vsi
Discard the used oral tubes in approved biological waste containers according to local regulations.
Uporabljeno tubo zavrzite v ustrezen vsebnik za odstranjevanje bioloških odpadkov v skladu z lokalnimi predpisi.
10 tubes 10 x 1 dose (1.5 ml)
10 tub 10 x 1 odmerek (1,5 ml)
The protective vaccine efficacy (pooled doses) observed against any and severe rotavirus gastro-enteritis is presented in the following table:
Učinkovitost zaščite cepiva (združeni odmerki), ki je bila opažena proti rotavirusnemu gastroenteritisu katerekoli jakosti in proti hudemu rotavirusnemu gastroenteritisu, je predstavljena v spodnji preglednici:
• Once the tube is open check the liquid is clear,
• Ko je tuba odprta, preverite, da je tekočina bistra, brez prisotnih delcev.
Oral applicator
Peroralni aplikator
PARTICULARS TO APPEAR ON THE OUTER PACKAGING TUBE, PACK SIZES OF 1, 10 OR 50
PODATKI NA ZUNANJI OVOJNINI TUBA, VELIKOST PAKIRANJA 1, 5 ALI 50
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 single dose tubes
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 5 enoodmernih tub
The severe RV gastro-enteritis cases were due to RV strains G1P[8], G2P[4], G3P[8] and G9P[8].
Primere hudega RV gastroenteritisa so povzročili sevi RV G1P[8], G2P[4], G3P[8]
STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (1.5 ml) contains:
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 odmerek (1,5 ml) vsebuje:
In general, the adverse event profile reported in these cases was similar to that observed after administration of the recommended dose of Rotarix.
Poročani neželeni učinki so bili v glavnem podobni neželenim učinkom po dajanju priporočenega odmerka cepiva Rotarix.
Pull off the cap
Snemite zaporko
The following table shows the percentage of subjects initially seronegative for rotavirus (IgA antibody titres < 20 U/ml) (by ELISA) with serum anti-rotavirus IgA antibody titres ≥20U/ml one to two months after the second dose of vaccine or placebo as observed in different studies with Rotarix lyophilised formulation.
V spodnji preglednici so prikazani odstotki oseb, ki so bile predhodno seronegativne na rotavirus (titri IgA protiteles < 20 e/ml) (ELISA), pri katerih je bil en ali dva meseca po aplikaciji drugega odmerka cepiva ali placeba v različnih študijah liofilizirane oblike cepiva Rotarix dosežen titer serumskih protirotavirusnih IgA protiteles ≥ 20 e./ml.
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.
The oral applicator containing the reconstituted vaccine should be shaken gently again before oral administration.
Pred peroralno aplikacijo morate peroralni aplikator z rekonstituiranim cepivom ponovno nežno pretresti.
• abdominal pain (see also below for signs of very rare side effects of intussusception)
♦ Občasni (neželeni učinki, ki se lahko pojavijo pri manj kot 1 na 100 odmerkov cepiva): • bolečine v trebuhu (glejte tudi znake zelo redkega neželenega učinka invaginacije spodaj)
2, 4 months Spain
2. in 4. mesec
The following table shows the percentage of subjects initially seronegative for rotavirus (IgA antibody titres < 20 U/ml) (by ELISA) with serum anti-rotavirus IgA antibody titres ≥ 20U/ml one to two months after the second dose of vaccine or placebo as observed in different studies.
V spodnji preglednici so prikazani odstotki oseb, ki so bile predhodno seronegativne na rotavirus (titri IgA protiteles < 20 e/ml) (ELISA), 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.
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.
The mixed vaccine will appear more turbid than the solvent alone.
Tako pripravljeno cepivo je na videz bolj motno kot pa sam vehikel.
The protective vaccine efficacy after two doses of Rotarix observed against severe rotavirus gastroenteritis up to 2 years of age is presented in the following table:
V spodnji preglednici je prikazana učinkovitost zaščite cepiva po dveh odmerkih cepiva Rotarix, opažena proti hudemu rotavirusnemu gastroenteritisu v starosti do 2 let:
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 katerimkoli 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. S kliničnimi študijami so dokazali, da se imunski odziv in varnostni profil apliciranih cepiv ne spremeni.
Pre-filled oral applicator
Napolnjen peroralni aplikator
After the reconstitution, the vaccine should be administered immediately.
Rekonstituirano cepivo je treba uporabiti takoj.
Viral antigen particles detected by ELISA were found in 50% of stools after the first dose and 4% of stools after the second dose.
Po aplikaciji prvega odmerka cepiva so s testom ELISA odkrili virusne antigene v 50 % vzorcev blata, po aplikaciji drugega odmerka cepiva pa v 4 % vzorcev blata.
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pred rekonstitucijo:
In the event of either being observed, discard the vaccine.
Če opazite kar koli od navedenega, cepivo zavrzite.
Clinical studies have been conducted in Europe, Latin America, Africa and Asia to evaluate the protective efficacy of Rotarix against any and severe rotavirus gastro-enteritis.
Klinične študije, ki so vrednotile učinkovitost zaščite pred katerimkoli rotavirusnim gastroenteritisom oziroma pred hudim rotavirusnim gastroenteritisom, so bile izvedene v Evropi, Latinski Ameriki, Afriki in Aziji.
These data are considered sufficient to support the inclusion of urticaria in section 4.8 of the SmPC with the frequency very rare, as the SmPC guideline recommends to list in section 4.8 all adverse reactions for which, after a thorough assessment, a causal relationship between the medicinal product and the adverse event is at least a reasonable possibility.
Smernice za SmPC priporočajo navajanje vseh neželenih učinkov, za katera je po podrobni oceni vzročna povezava med zdravilom in neželenim učinkom smiselno vrjetna, v poglavje 4.8.
When Rotarix is given to your child for the first dose, it is recommended that your child also receives Rotarix (and not another rotavirus vaccine) for the second dose.
Če je otrok prejel prvi odmerek cepiva Rotarix, priporočamo, da prejme tudi drugi odmerek cepiva Rotarix
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GLASS CONTAINER WITH POWDER TO BE RECONSTITUTED WITH SOLVENT
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH STEKLENIČKA S PRAŠKOM, KI SE GA REKONSTITUIRA Z VEHIKLOM
10 glass containers: powder 10 oral applicators: solvent 10 transfer adapters 10 x 1 dose (1 ml)
10 steklenih vsebnikov: prašek 10 peroralnih aplikatorjev: vehikel 10 nastavkov za prenos 10 x 1 odmerek (1 ml)
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8].
V kliničnih preskušanjih so dokazali učinkovitost proti gastroenteritisu, ki ga povzročajo rotavirusi najpogostejših genotipov G1P[8], G2P[4], G3P[8], G4P[8] in G9P[8].
Transfer adapter for reconstitution (1/dose) in the following pack sizes:
Nastavek za prenos pri rekonstituciji (1/odmerek).
Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1).
Uporabljamo ga za preprečevanje rotavirusnega gastroenteritisa (glejte poglavja 4.2, 4.4 in 5.1).
• Hold the tube upright.
• Tubo držite pokončno.
Rotarix oral suspension in pre-filled oral applicator Rotarix oral suspension in squeezable tube
Rotarix peroralna suspenzija v napolnjenem peroralnem aplikatorju Rotarix peroralna suspenzija v tubi
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] genotype during the first year of life.
Združena analiza petih študij* kaže, da je bila med prvim letom življenja učinkovitost proti hudemu rotavirusnemu gastroenteritisu (Vesikari ≥ 11), ki ga povzroča genotip G2P[4] rotavirusa 71,4-odstotna
< 5 yrs
< 5 let
STATEMENT OF ACTIVE SUBSTANCE(S) After reconstitution, 1 dose (1 ml) contains:
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Po rekonstituciji 1 odmerek (1 ml) vsebuje:
In a clinical study conducted in preterm infants, born after at least 27 weeks of gestational age, the immunogenicity of Rotarix was assessed in a subset of 147 subjects and showed that Rotarix is immunogenic in this population; 85.7% (95% CI: 79.0;90.9) of subjects achieved serum anti-rotavirus IgA antibody titres ≥ 20U/ml (by ELISA) one month after the second dose of vaccine.
Izkazalo se je, da je cepivo Rotarix v tej populaciji imunogeno; en mesec po drugem odmerku cepiva je 85,7 % (95 % IZ: 79,0; 90,9) preiskovancev doseglo serumske titre IgA protiteles proti rotavirusu ≥ 20 e./ml (določeno z ELISA).
Rotarix should be administered with caution to individuals with immunodeficient close contacts, such as individuals with malignancies, or who are otherwise immunocompromised or individuals receiving immunosuppressive therapy.
Pri otrocih, ki so v tesnem stiku z osebami z imunsko pomanjkljivostjo, npr. osebami z rakavimi obolenji, s kakorkoli drugače oslabljenim imunskim sistemom ali osebami, ki se zdravijo z imunosupresivnimi zdravili,
1 glass container: powder 1 oral applicator: solvent 1 transfer adapter 1 dose (1 ml)
1 steklen vsebnik: prašek 1 peroralni aplikator: vehikel 1 nastavek za prenos 1 odmerek (1 ml)
Powder and solvent for oral suspension
Prašek in vehikel za peroralno suspenzijo
The vaccine contains sucrose as an excipient.
Cepivo vsebuje saharozo kot pomožno snov.
It is recommended that infants who receive a first dose of Rotarix complete the 2-dose regimen with Rotarix.
Priporočamo, da otroci, ki so prejeli prvi odmerek cepiva Rotarix, prejmejo tudi drugi odmerek cepiva Rotarix, in da se tako začeto cepljenje zaključi z istim cepivom.
Please read the instructions for use all the way through before starting to give the vaccine.
Preden začnete dajati cepivo, preberite celotno navodilo za uporabo.
Apnoea in very premature infants (≤ 28 weeks of gestation)
apneja pri veliko prezgodaj rojenih nedonošenčkih (rojenih pred ali v 28. tednu nosečnosti) (glejte poglavje 4.4)
Rotarix oral suspension in multi-monodose (5 single dose) squeezable tube presentation connected by a bar Rotavirus vaccine, live
Rotarix peroralna suspenzija v kompletu več enoodmernih tub (5 posameznih odmerkov), ki so med seboj povezane s ploščico cepivo proti rotavirusom, živo
• 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.
Discard the empty tube and cap in approved biological waste containers according to local regulations.
Prazno tubo in zaporko zavrzite v ustrezen vsebnik za odstranjevanje bioloških odpadkov v skladu z lokalnimi predpisi.
Rotarix contains sucrose
Cepivo Rotarix vsebuje saharozo
25 glass containers: powder 25 oral applicators: solvent 25 transfer adapters 25 x 1 dose (1 ml)
25 steklenih vsebnikov: prašek 25 peroralnih aplikatorjev: vehikel 25 nastavkov za prenos 5 x 1 odmerek (1 ml)
After two doses of Rotarix, the protective vaccine efficacy observed during the first and second year of life is presented in the following table:
V spodnji preglednici je prikazana učinkovitost zaščite cepiva med prvim in drugim letom življenja po aplikaciji dveh odmerkov cepiva Rotarix:
Severe rotavirus gastroenteritis† Rotarix N=2,974 Placebo N=1,443
Hud rotavirusni gastroenteritis† Rotarix n=2.974 Placebo n=1.443
Rotarix is for oral use only.
Cepivo Rotarix je namenjeno izključno za peroralno uporabo.
• 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;
5 glass containers: powder 5 oral applicators: solvent 5 transfer adapters 5 x 1 dose (1 ml)
5 steklenih vsebnikov: prašek 5 peroralnih aplikatorjev: vehikel 5 nastavkov za prenos 5 x 1 odmerek (1 ml)
MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a.
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM GlaxoSmithKline Biologicals s.a.
The first dose may be given from the age of 6 weeks.
Otrok lahko prejme prvi odmerek cepiva, ko je star 6 tednov ali več.
History of intussusception.
Invaginacija v anamnezi.
Dermatitis
Občasni dermatitis
What you need to know before your child receives Rotarix
Kaj morate vedeti, preden bo vaš otrok prejel cepivo Rotarix Vaš otrok cepiva Rotarix ne sme prejeti:
Glass container
Povezovalna ploščica