FrancophonIA/ELRC3.0 huggingface dataset:
English: Severity of gastro-enteritis was defined according to two different criteria: - 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 or - the clinical case definition based on World Health Organization (WHO) criteria
Danish: Sværhedsgraden af gastroenteritis blev defineret ud fra to forskellige kriterier: - Vesikari 20-point skalaen, som vurderer det samlede kliniske billede af rotavirus-gastroenteritis ved sværhedsgraden og varigheden af diarré og opkastning, sværhedsgraden af feber og dehydrering samt behovet for behandling.
English: 8-11 m
Danish: 8-11 mdr.
English: A clinical study conducted in Asia (Hong Kong, Singapore and Taiwan) (Total vaccinated cohort : Rotarix: N = 5,359; placebo: N = 5,349) evaluated Rotarix given according to different schedules (2, 4 months of age; 3, 4 months of age).
Danish: I et klinisk studie udført i Asien (Hong Kong, Singapore og Taiwan) (Total vaccineret kohorte: Rotarix: n = 5.359; placebo: n = 5.349) blev Rotarix vurderet efter administration af forskellige vaccinationsprogrammer (ved 2- og 4-måneders-alderen; ved 3- og 4-måneders-alderen).
English: Excretion of the vaccine virus in the stools is known to occur after vaccination with peak excretion around the 7th day.
Danish: Efter vaccinering udskilles vaccinevirus via afføring med maksimum udskilning omkring 7. dagen.
English: Other medicines and Rotarix
Danish: Brug af anden medicin sammen med Rotarix
English: 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.
Danish: I et klinisk studie med 147 præmature børn tidligst født efter uge 27 af svangerskabet blev immunogeniciteten af Rotarix undersøgt, og det blev vist, at Rotarix er immunogen i denne population; 85,7 % (95 % CI: 79,0; 90,9) af børnene opnåede serum-anti-rotavirus-IgA-antistoftitre ≥ 20 E/ml (ved ELISA) en måned efter anden vaccinedosis.
English: Viral antigen particles detected by ELISA were found in 50% of stools after the first dose and 4% of stools after the second dose.
Danish: Ved hjælp af ELISA blev der målt antigener i 50 % af afføringerne efter første dosis og i 4 % efter anden dosis.
English: Effectiveness after 2 doses in preventing RVGE leading to hospitalization Countries
Danish: Effektive virkning efter 2 doser til forebyggelse af RVGE som kræver indlæggelse på hospital Land Periode
English: Efficacy up to 2 years of age Rotarix N= 5,263 Placebo N= 5,256 Vaccine efficacy (%) against severe rotavirus gastro-enteritis [95% CI] Genotype
Danish: Effekt hos børn i op til 2-års-alderen Rotarix n = 5.263 Placebo n = 5.256 Effekt (%) mod alvorlig rotavirus-gastroenteritis [95 % CI] Genotype
English: After reconstitution, the vaccine contained in the oral applicator should be administered promptly.
Danish: Efter rekonstituering skal vaccinen i den orale applikator anvendes med det samme.
English: 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.
Danish: Da immunresponset, som blev opserveret efter 2 doser Rotarix (suspension) er sammenlignelig med immunresponset observeret efter 2 doser Rotarix (frysetørret pulver), kan niveauet for vaccineeffektivitet for lægemiddelformen frysetørret pulver ekstrapoleres til lægemiddelformen suspension.
English: N % ≥ 20U/ml [95% CI]
Danish: ≥ 20 E/ml [95 % CI]
English: Position the child to give the vaccine • Seat the child leaning slightly backwards.
Danish: Gør barnet klar til at få vaccinen • Sæt barnet i en let tilbagelænet stilling.
English: Powder and solvent for oral suspension.
Danish: Pulver og solvens til oral suspension.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.5 ml) contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 dosis (1,5 ml) indeholder:
English: A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastro-enteritis has not been established.
Danish: Der er ikke etableret en sammenhæng mellem antistofkoncentration opnået ved rotavirus-vaccination og beskyttelse mod rotavirus-gastroenteritis.
English: In a retrospective database study in Belgium conducted in children 5 years of age and younger, the direct and indirect impact of Rotarix vaccination on rotavirus-related hospitalisation ranged from 64% (95% CI: 49;76) to 80% (95% CI: 77;83) two years after vaccine introduction.
Danish: I et retrospektivt database-studie udført i Belgien med børn på 5 år og derunder varierede den direkte og den indirekte indvirkning af Rotarix-vaccine på rotavirus-relateret hospitalisering fra 64 % (95% CI: 49; 76) til 80 % (95% CI: 77; 83) to år efter introduktion af vaccinen.
English: Do not inject!
Danish: Må ikke injiceres!
English: Powder and solvent for oral suspension
Danish: Pulver og solvens til oral suspension
English: Rotarix is available in a pack of 1, 5, 10 or 25.
Danish: Rotarix findes i pakninger á 1, 5, 10 eller 25 stk.
English: Any unused vaccine or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt vaccine eller affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: • if your child has a rare inherited illness which affects their immune system called Severe Combined Immunodeficiency (SCID).
Danish: • hvis dit barn har en sjælden, arvelig sygdom, der påvirker immunsystemet (svær kombineret immundefekt (SCID)).
English: The vaccine (1.5 ml liquid) will be given orally.
Danish: Vaccinen (1,5 ml væske) gives i munden.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Rotarix
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til Rotarix
English: The safety profile was similar between Rotarix and placebo recipients.
Danish: Bivirkningsprofilen var sammenlignelig for Rotarix-gruppen og placebo-gruppen.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVEREING OG ANVENDELSE
English: The oral applicator containing the reconstituted vaccine should be shaken gently again before oral administration.
Danish: Den orale applikator indeholdende rekonstiueret vaccine skal omrystes forsigtigt igen lige før administration.
English: Rotarix contains sucrose
Danish: Rotarix indeholder saccharose
English: In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.
Danish: Hvis dit barn spytter det meste af den indgivne vaccinedosis ud eller gylper den op, kan en erstatningsdosis gives med det samme, inden du forlader lægens konsultation.
English: C. Give the vaccine orally immediately after opening
Danish: C. Administrer vaccinen oralt straks efter åbning 1.
English: 1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber butyl) and a protective tip cap (rubber butyl), in pack sizes of 1, 5, 10 or 25.
Danish: 1,5 ml oral suspension i en fyldt oral applikator (type I glas) med stempelprop (butylgummi) og med en beskyttelseshætte (butylgummi) i pakningsstørrelserne 1, 5, 10 eller 25.
English: Powder: dextran, sucrose, sorbitol (see also section 2, Rotarix contains sucrose and sorbitol), amino acids, Dulbecco's Modified Eagle Medium (DMEM) Solvent: calcium carbonate, xanthan gum, sterile water
Danish: Pulver: dextran, saccharose, sorbitol (se også afsnit 2, Rotarix indeholder saccharose og sorbitol), aminosyrer, Dulbecco's Modified Eagle Medium (DMEM)
English: The vaccine efficacy against severe rotavirus gastro-enteritis during the first year of life was 61.2% (95% CI: 44.0;73.2).
Danish: Effekten mod alvorlige typer rotavirus-gastoenteritis var i første leveår 61,2 % (95 % CI: 44,0; 73,2).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (1 ml) contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Efter rekonstituering, indeholder 1 dosis (1 ml):
English: (6) In subjects who did not receive the full course of vaccination, the effectiveness after one dose ranged from 51% (95% CI: 26;67, El Salvador) to 60% (95% CI: 37;75, Brazil).
Danish: (6) Hos personer, som ikke fik hele vaccinationsprogrammet, varierede effektiviteten efter en dosis fra 51% (95% CI: 26; 67, El Salvador) til 60 % (95 % CI: 37; 75, Brasilien).
English: 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.
Danish: En samlet analyse af fem effektivitetsstudier*, viste en effektivitet på 71,4 % (95 % CI: 20,1; 91,1) mod alvorlige typer rotavirus-gastroenteritis (Vesikari score > 11) forårsaget af rotavirus type G2P[4]-genotype i løbet af det første leveår.
English: 1st year of life Rotarix N=2,572 Placebo N=1,302
Danish: 1. leveår Rotarix n = 2.572 Placebo n = 1.302
English: To administer the vaccine orally:
Danish: Administrer vaccinen oralt:
English: Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix.
Danish: Baseret på evidens fra kliniske studier reducerer amning ikke den beskyttelse mod rotavirusgastroenterititis, som Rotarix giver.
English: Store in the original package, in order to protect from light.
Danish: Opbevares i den originale pakning for at beskytte mod lys.
English: Shake the oral applicator containing the solvent vigorously.
Danish: Omryst den orale applikator med solvens kraftigt .
English: During the first year, significantly fewer subjects in the Rotarix group reported severe rotavirus gastroenteritis caused by the circulating wild-type RV compared to the placebo group from 2 weeks after Dose 2 up to one year of age (0.0% versus 0.3%), with a vaccine efficacy of 100% (95% CI: 72.2;
Danish: I løbet af det første år (i perioden fra 2 uger efter anden dosis indtil 1-års-alderen) sås signifikant færre børn i Rotarix-gruppen med alvorlig rotavirus-gastroenteritis forårsaget af den naturligt forekommende rotavirus sammenlignet med placebo-gruppen (0,0 % versus 0,3 %), med en vaccineeffekt på 100 % (95 % CI: 72,2; 100).
English: Vaccine efficacy (%) against rotavirus gastro-enteritis requiring hospitalisation and/or rehydration therapy in a medical facility [95% CI] Circulating rotavirus strains † Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale * Not statistically significant (p ≥ 0.05).
Danish: Effekt (%) mod rotavirus-gastroenteritis, som kræver hospitalisering og/eller rehydrering under lægelig supervision [95 % CI] Cirkulerende rotavirusstammer † Alvorlig gastroenteritis blev defineret ved en score ≥ 11 på Vesikari-skalaen * Ikke statistisk signifikant (p ≥ 0,05).
English: • he/she has a close contact such as a household member who has a weakened immune system,
Danish: • han/hun har tæt kontakt til personer med nedsat immunforsvar, f.eks. personer i din husstand.
English: 2, 3 to 4 months
Danish: 2, 3 - 4 mdr.
English: Rotarix is available in a pack of 1, 10 or 50.
Danish: Rotarix findes i pakninger á 1, 10 eller 50 stk.
English: f) Twist the separated oral tube.
Danish: f) Drej den separerede tube rundt.
English: What you need to know before your child receives Rotarix
Danish: Det skal du vide, før dit barn får Rotarix
English: 2nd year of life Rotarix N=2,554 Placebo N=1,294 Vaccine efficacy (%) against any and severe rotavirus gastro-enteritis [95% CI]
Danish: 2. leveår Rotarix n = 2.554 Placebo n = 1.294 Effekt (%) mod enhver type rotavirus-gastroenteritis og mod alvorlige typer rotavirus-gastroenteritis [95 % CI]
English: g) Pull it from the connecting bar.
Danish: g) Træk tuben af den sammenhængende plade.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/330/012 - pack of 50 tubes 13.
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/330/012 - pakning med 50 tuber
English: Subjects with Severe Combined Immunodeficiency (SCID) disorder (see section 4.8).
Danish: Personer med svær kombineret immundefekt (SCID − severe combined immune deficiency) (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/330/009 - pack of 1 tube EU/1/05/330/010 - pack of 10 tubes EU/1/05/330/011 - pack of 50 tubes
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/330/009 - pakning med 1 tube EU/1/05/330/010 - pakning med 10 tuber EU/1/05/330/011 - pakning med 50 tuber
English: Under no circumstance should this vaccine be administered by injection.
Danish: Vaccinen må under ingen omstændigheder injiceres.
English: 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).
Danish: Stammer med P[8]genotype † Alvorlig rotavirus-gastroenteritis blev defineret som en diaréepisode med eller uden opkastning, som krævede hospitalisering og/eller rehydrering under lægelig supervision (WHO-kriterie) * Ikke statistisk signifikant (p ≥ 0,05).
English: The shaken suspension will appear as a turbid liquid with a slow settling white deposit
Danish: Den omrystede solvens vil fremstå som en uklar væske med et langsomt sættende hvidt bundfald.
English: Connect the transfer adapter onto the glass container by pushing it downwards until the transfer adapter is properly and securely placed
Danish: Sæt overførselsaggregatet på glasbeholderen ved at trykke nedad, indtil overførselsaggregatet er placeret sikkert på toppen af glasbeholderen.
English: Effectiveness after 2 doses in preventing RVGE leading to hospitalization
Danish: Effektive virking efter 2 doser til forebyggelse af RVGE som kræver indlæggelse på hospital Land Periode
English: 1.5 ml of oral suspension in a squeezable tube (polyethylene) fitted with a membrane and a tube cap (polypropylene), in pack sizes of 1, 10 or 50.
Danish: 1,5 ml oral suspension i en blød tube (polyethylen) forsynet med membran og tubehætte (polypropylen) i pakningsstørrelserne 1, 10 eller 50.
English: • You do not need to twist.
Danish: • Du skal ikke dreje tubehætten rundt.
English: Brazil
Danish: Brasilien
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING TUBE, PACK SIZES OF 1, 10 OR 50
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE TUBE, PAKNINGSSTØRRELSER 1, 10 ELLER 50
English: To open the tube
Danish: Åbning af tuben
English: • children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their stools.
Danish: • børn, som lider af en sjælden, arvelig sygdom kaldet svær kombineret immundefekt (SCID), kan have mave-tarmkatar og udskille vaccinevirus med afføringen.
English: It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on longer periods of follow-up (see section 4.4).
Danish: Baseret på længerevarende opfølgningsperioder er det fortsat uklart, om rotavirusvacciner har indvirkning på den overordnede incidens af invagination (se pkt.
English: Remove the protective tip cap from the oral applicator.
Danish: Fjern beskyttelseshætten fra den orale applikator.
English: Immune response
Danish: Immunrespons
English: In a clinical study, 670 pre-term infants from 27 to 36 weeks of gestational age were administered Rotarix and 339 received placebo.
Danish: I et klinisk studie blev Rotarix administreret til 670 præmature børn født i uge 27-36 af svangerskabet, og 339 børn fik placebo.
English: 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.
Danish: Følgende tabel viser procentdelen af personer, som initialt var seronegative for rotavirus (IgAantistoftiter < 20 E/ml) (ved ELISA) med serum-anti-rotavirus-IgA-antistoftitre > 20 E/ml 1-2 måneder efter anden vaccinedosis henholdsvis placebo i forskellige studier.
English: 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.
Danish: Ved hjælp af ELISA blev der målt antigener i 50 % af afføringerne efter første dosis af Rotarix (frysetørret pulver formulering) og i 4 % efter anden dosis.
English: EU/1/05/330/001 - pack of 1 (glass container + oral applicator + transfer adapter) EU/1/05/330/002 - pack of 5 (glass container + oral applicator + transfer adapter) EU/1/05/330/003 - pack of 10 (glass container + oral applicator + transfer adapter) EU/1/05/330/004 - pack of 25 (glass container + oral applicator + transfer adapter)
Danish: EU/1/05/330/001- 1 stk. pakning (glasbeholder + oral applikator + overførselsaggregater) EU/1/05/330/002 - 5 stk. pakning (glasbeholder + oral applikator + overførselsaggregater) EU/1/05/330/003 - 10 stk. pakning (glasbeholder + oral applikator + overførselsaggregater) EU/1/05/330/004 - 25 stk. pakning (glasbeholder + oral applikator + overførselsaggregater)
English: Severe rotavirus gastroenteritis† (2nd year of life) Rotarix N=7,175 Placebo N=7,062
Danish: Alvorlige typer rotavirusgastroenteritis† (2. leveår) Rotarix n = 7.175 Placebo n = 7.062
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 single dose tubes
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 5 enkeltdoser i tube
English: Similar rates of other adverse events were observed in Rotarix and placebo recipients.
Danish: Andre bivirkninger blev set med sammenlignelige hyppigheder i Rotarix-gruppen og placebo-gruppen.
English: In three comparative controlled trials, the immune response elicited by Rotarix liquid formulation was comparable to the one elicited by Rotarix lyophilised formulation.
Danish: I tre sammenlignende kontrollerede studier var immunresponset fremkaldt af Rotarix (suspension) sammenligneligt med det fremkaldt af Rotarix (frysetørret pulver).
English: B Get the tube ready
Danish: B Klargør tuben
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (1.5 ml) contains:
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 dosis (1,5 ml) indeholder:
English: US
Danish: USA
English: 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.
Danish: c) Træk i fanen og riv den af tuben ved siden af.
English: 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:
Danish: Den beskyttende virkning efter administration af to doser Rotarix mod alvorlig rotavirusgastroenteritis hos børn i op til 2-års-alderen er angivet i nedenstående tabel:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS TUBE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER TUBE
English: 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).
Danish: 1 ml solvens i oral applikator (type I glas) med en stempelprop og en beskyttelseshætte (butylgummi).
English: LIST OF EXCIPIENTS Sucrose
Danish: LISTE OVER HJÆLPESTOFFER Saccharose
English: • if your child has previously had intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).
Danish: • hvis dit barn tidligere har haft en speciel form for tarmslyng, hvor en del af tarmen forskubbes ind i en anden del (invagination).
English: A. What you need to do before giving Rotarix
Danish: A. Det skal du vide, før du giver Rotarix
English: Severe rotavirus gastroenteritis† (1st year of life) Rotarix N=9,009 Placebo N=8,858
Danish: Alvorlige typer rotavirusgastroenteritis† (1. leveår) Rotarix n = 9.009 Placebo n = 8.858
English: If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.
Danish: Hvis du glemmer et besøg, skal du kontakte din læge.
English: Strains with P[8] genotype † Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale * Not statistically significant (p ≥ 0.05).
Danish: Stammer med P[8]genotype † Alvorlig gastroenteritis blev defineret ved en score ≥ 11 på Vesikari-skalaen * Ikke statistisk signifikant (p ≥ 0,05).
English: 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
Danish: EU/1/05/330/005 - pakning med 1 fyldt oral applikator EU/1/05/330/006 - pakning med 5 fyldte orale applikatorer EU/1/05/330/007 - pakning med 10 fyldte orale applikatorer EU/1/05/330/008 - pakning med 25 fyldte orale applikatorer
English: This product contains sucrose 1,073 mg (see section 4.4).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Dette produkt indeholder 1.073 mg saccharose (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GLASS CONTAINER WITH POWDER TO BE RECONSTITUTED WITH SOLVENT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER GLASBEHOLDER MED PULVER TIL REKONSTITUERING MED SOLVENS
English: • Hold the tube upright.
Danish: • Hold tuben lodret.
English: The protective vaccine efficacy against severe rotavirus (RV) gastro-enteritis requiring hospitalisation and/or rehydration therapy in a medical facility and the genotype specific vaccine efficacy after two doses of Rotarix are presented in the table below:
Danish: Graden af beskyttelse efter vaccination mod alvorlige typer rotavirus RV)-gastroenteritis krævende hospitalisering og/eller medicinsk behandling af dehydrering versus genotype-specifik effektivitet af vaccinen efter 2 doser Rotarix er angivet i tabellen nedenfor.
English: 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.
Danish: Følgende tabel viser procentdelen af personer, som initialt var seronegative for rotavirus (IgAantistoftiter < 20 E/ml) (ved ELISA) med serum-anti-rotavirus-IgA-antistoftitre > 20 E/ml 12 måneder efter anden vaccinedosis henholdsvis placebo i forskellige studier med Rotarix (frysetørret pulver).
English: 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.
Danish: I et klinisk studie blev Rotarix (frysetørret pulver formulering) administreret til 670 præmature børn født i uge 27-36 af svangerskabet, og 339 børn fik placebo.
English: Pull off the cap
Danish: Pres hætten ned
English: In a pooled analysis from seventeen placebo-controlled clinical trials (Europe, North America, Latin America, Asia, Africa) including trials in which Rotarix was co-administered with routine paediatric vaccines (see section 4.5), the following adverse reactions (collected 31 days post-vaccination) were considered as possibly related to vaccination.
Danish: I en samlet analyse af sytten placebokontrollerede, kliniske studier (Europa, Nordamerika, Latinamerika, Asien, Afrika) inklusive studier, hvor Rotarix blev givet samtidig med rutinemæssige børnevaccinationer (se pkt.
English: • Then lift off the cap.
Danish: • Løft derefter tubehætten op.
English: Glass container
Danish: Glasbeholder