FrancophonIA/ELRC3.0 huggingface dataset:
English: These strains are circulating worldwide.
Danish: Disse stammer cirkulerer i hele verden.
English: As always, please take care to wash your hands thoroughly after changing soiled nappies.
Danish: Vask, som altid, hænderne grundigt efter bleskift.
English: Despite a low reporting rate of urticaria events (i.e. 0.013 cases per 100,000 doses distributed), some spontaneous cases suggested a possible association between Rotarix vaccination and urticaria.
Danish: På trods af en lav rapporteringshyppighed for urticaria-hændelser (dvs. 0,013 tilfælde pr. 100.000 doser) tydede nogle spontane tilfælde på en mulig sammenhæng mellem Rotarix-vaccination og urticaria.
English: Read all of this leaflet carefully before your child receives this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden dit barn får vaccinen, da den indeholder vigtige oplysninger.
English: • 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).
Danish: • hvis dit barn tidligere har haft en allergisk reaktion over for en rotavirus-vaccine eller et af de øvrige indholdsstoffer i denne vaccine (angivet i punkt 6).
English: Adverse reactions reported are listed according to the following frequency:
Danish: De rapporterede bivirkninger er listet efter følgende hyppigheder:
English: • Check the tube has not been damaged nor is already open.
Danish: • Tjek at tuben ikke er beskadiget og at den ikke allerede er åbnet.
English: These antibodies protect against disease caused by these types of rotavirus.
Danish: De dannede antistoffer beskytter mod sygdomme, forårsaget af disse typer rotavirus.
English: Check that each individual oral tube is not damaged and is still sealed.
Danish: Tjek at hver enkelt tube ikke er beskadiget og stadig er forseglet.
English: Most children with rotavirus diarrhoea recover on their own.
Danish: De fleste børn med rotavirus-diarré bliver selv raske.
English: When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the most commonly occurring types of rotavirus.
Danish: Når dit barn får vaccinen, vil immunsystemet (kroppens naturlige forsvar) udvikle antistoffer mod de mest almindelige typer rotavirus.
English: Safety in preterm infants
Danish: Sikkerhed hos præmature børn
English: After reconstitution:
Danish: Efter rekonstituering:
English: Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person.
Danish: Rotavirus spredes nemt fra hånd til mund ved kontakt med afføring fra en inficeret person.
English: Before reconstitution:
Danish: Før rekonstituering:
English: §NOTE : Impact studies are meant to establish a temporal relationship but not a causal relationship between the disease and vaccination.
Danish: §BEMÆRK : Indvirkningsstudier er beregnet til at etablere en tidsmæssig sammenhæng, men ikke en årsagssammenhæng, mellem sygdom og vaccination.
English: C Check the tube has opened correctly 1.
Danish: C Se efter om tuben er åbnet korrekt 1.
English: Rotarix is for oral use only.
Danish: Rotarix er kun til oral anvendelse.
English: • if your child has a severe infection with a high temperature.
Danish: • hvis dit barn har en alvorlig infektion med høj feber.
English: In order to strengthen the current warning on administration of Rotarix to infants who have known or suspected immunodeficiency, it is recommended to update the current warning.
Danish: For at styrke den nuværende advarsel om administration af Rotarix til spædbørn, der har kendt eller mistænkt immundefekt, anbefales det at opdatere den aktuelle advarsel.
English: 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.
Danish: Op til yderligere 6 tilfælde per 100.000 spædbørn er set i disse lande i forhold til baggrundsincidensen på henholdsvis 25 til 101 per 100.000 spædbørn (under 1 år) per år.
English: 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.
Danish: Lignende studier udført i Armenien, Australien, Brasilien, Canada, El Salvador og Zambia viste en reduktion på 45 % til 93 % mellem 2 og 4 år efter introduktion af vaccinen.
English: *Produced on Vero cells
Danish: *fremstillet på veroceller
English: The vaccine is ready to use (no reconstitution or dilution is required).
Danish: Vaccinen er klar til brug (vaccinen skal ikke rekonstitueres eller fortyndes).
English: 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.
Danish: Data fra observations-sikkerhedsstudier udført i flere lande indikerer, at rotavirusvacciner kan medføre en øget risiko for invagination, oftest inden for 7 dage efter vaccination.
English: Expiry date: DD/MM/YY
Danish: Udløbsdato: DD/MM/ÅÅ
English: 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.
Danish: Det er god klinisk praksis, at der foretages en vurdering af den medicinske anamnese forud for vaccination specielt med hensyn til kontraindikationer, samt at der udføres en klinisk undersøgelse.
English: Rotarix should under no circumstances be injected.
Danish: Rotarix må under ingen omstændigheder injiceres.
English: There is limited evidence of a smaller increased risk following the second dose.
Danish: Der er begrænset evidens for en lidt forhøjet risiko efter dosis nummer 2.
English: In order to address the presence of porcine circovirus type 1(PCV-1) in Rotarix, the MAH commits to:
Danish: For at gøre noget ved tilstedeværelsen af porcine circovirus type 1(PCV-1) i Rotarix er indehaveren af markedsføringstilladelsen forpligtet til at:
English: A protective immune response may not be elicited in all vaccinees (see section 5.1).
Danish: Et beskyttende immunrespons opnås muligvis ikke hos alle vaccinerede (se pkt.
English: • There is a small spike inside the top of the cap - in the centre.
Danish: • Der er en lille spids inden i toppen af hætten - lige i midten.
English: Contact a doctor/health care professional right away if your child experiences one of these symptoms.
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis dit barn oplever nogen af disse symptomer.
English: - Pre-filled oral applicator: 3 years
Danish: - Fyldt oral applikator : 3 år.
English: Tell your doctor if your child is taking, has recently taken or might take any other medicines or has recently received any other vaccine.
Danish: Fortæl det altid til lægen, hvis dit barn får eller skal have anden medicin eller har fået det for nylig, eller hvis dit barn for nylig har fået en anden vaccine.
English: Do not hold the body of the oral tube, you may squeeze out some of the vaccine.
Danish: Hold ikke fast i tubekroppen, da du kan trykke noget af vaccinen ud.
English: 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.
Danish: Ubrugte tuber, der stadig er fastgjort til den sammenhængende plade, skal sættes tilbage i køleskabet straks efter at en tube er blevet anvendt.
English: It is recommended that infants who receive a first dose of Rotarix complete the 2-dose regimen with Rotarix.
Danish: Det anbefales, at børn, som modtager den første dosis Rotarix, fuldender 2-dosis programmet med Rotarix.
English: • This vaccine is ready to use - do not mix it with anything else.
Danish: • Vaccinen er klar til brug - du skal ikke blande den med noget.
English: e) Hold the tab of the separated oral tube in one hand and the connecting bar in the other hand.
Danish: e) Hold fanen af den separerede tube i den ene hånd og den sammenhængende plade med den anden hånd.
English: However, some children become very ill with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation.
Danish: Der er imidlertid børn, som bliver meget syge med alvorlig opkastning, diarré og livstruende væsketab, som kræver hospitalsindlæggelse.
English: • Very rare: hives (urticaria)
Danish: • meget sjælden: nældefeber (urticaria)
English: Date of first authorisation: 21 February 2006 Date of latest renewal: 14 January 2016
Danish: Dato for første markedsføringstilladelse: 21. februar 2006 Dato for seneste fornyelse: 14. januar 2016
English: Besides, the SmPC of immunosuppressive therapies, such as adalimumab, infliximab, includes a recommendation to defer live vaccine administration in infants who were exposed in utero to these treatments.
Danish: Desuden indeholder SmPC'er for immunsuppressive behandlinger, såsom adalimumab, infliximab, en anbefaling om at udsætte administration af levende vacciner til spædbørn, der er blevet eksponeret for disse behandlinger in utero.
English: Rotarix may be given according to the same vaccination course to infants who were born prematurely, provided that the pregnancy had lasted at least 27 weeks.
Danish: Rotarix kan gives med samme vaccinationsinterval til børn, som er født for tidligt, under forudsætning af, at graviditeten har varet i mindst 27 uger.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
Danish: De prækliniske data viser ingen særlig risiko for mennesker på basis af traditionelle forsøg af gentagen dosistoksicitet.
English: Serious adverse events were observed in 5.1% of recipients of Rotarix as compared with 6.8% of placebo recipients.
Danish: Alvorlige bivirkninger blev set hos 5,1 % af de børn, som fik Rotarix, sammenlignet med 6,8 % hos dem, som fik placebo.
English: No increase in the incidence or severity of these events was seen with the second dose.
Danish: Der sås ingen stigning i forekomst eller sværhedsgrad af disse bivirkninger efter anden dosis.
English: Hypersensitivity after previous administration of rotavirus vaccines.
Danish: Overfølsomhed ved tidligere administration af rotavirus-vacciner.
English: D. Store remaining doses in the fridge immediately
Danish: D. Opbevar resterende doser i køleskabet med det samme
English: ♦ Common (These may occur with up to 1 in 10 doses of the vaccine):
Danish: ♦ Almindelig (kan forekomme ved op til 1 ud af 10 vaccinedoser):
English: There is also a transfer adapter which allows easy transfer of the solvent into the glass container containing the powder for mixing the different components of the vaccine.
Danish: Der er også et overførselsaggregat, som muliggør en nem overførsel af solvens til glasbeholderen med pulver med henblik på blanding af de to vaccinekomponenter.
English: There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa.
Danish: Der er ingen data med hensyn til sikkerhed, immunogenicitet eller effektivitet, hvis Rotarix gives som første dosis og en anden rotavirus-vaccine gives som anden dosis eller vice versa.
English: Severity of gastro-enteritis (GE) was defined according to WHO criteria.
Danish: Sværhedsgraden af gastroenteritis (GE) blev defineret efter WHOs kriterier.
English: Check the membrane has been pierced
Danish: Tjek at membranen er blevet perforeret
English: The child should be seated in a reclining position.
Danish: Barnet skal sidde i en tilbagelænet stilling.
English: Section 4.4 of the SmPC of Rotarix includes a warning on administration of Rotarix to infants who have known or suspected immunodeficiency.
Danish: 4.4 i SmPC'et for Rotarix indeholder en advarsel om administration af Rotarix til spædbørn, som har kendt eller mistænkt immundefekt.
English: 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.
Danish: Separer en tube fra de andre fra den ene ende: a) Tag fat i fanen af en af de ydre tuber for at separere den fra de andre.
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Danish: Den potentielle risiko for apnø og behov for overvågning af respirationen i 48-72 timer skal overvejes ved primære immuniseringsprogrammer hos meget tidligt fødte børn (fødsel ≤ uge 28 af svangerskabet) og specielt hos tidligere respiratorisk immature børn.
English: - Squeezable tube fitted with a membrane and a tube cap: 3 years
Danish: - Blød tube forsynet med membran og tubehætte: 3 år
English: Abdominal pain, flatulence
Danish: Abdominalsmerter, flatulens
English: In general, the adverse event profile reported in these cases was similar to that observed after administration of the recommended dose of Rotarix.
Danish: Generelt var bivirkningsprofilen i disse tilfælde den samme, som blev observeret efter administration af den anbefalede dosis Rotarix.
English: The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks.
Danish: Vaccinationsprogrammet skal helst være gennemført før 16-ugers-alderen, og skal være afsluttet ved 24-ugers-alderen.
English: ♦ Uncommon (These may occur with up to 1 in 100 doses of the vaccine):
Danish: ♦ Ikke almindelig (kan forekomme ved op til 1 ud af 100 vaccinedoser):
English: Concomitant administration of Rotarix and oral polio vaccine (OPV) does not affect the immune response to the polio antigens.
Danish: Samtidig administration af Rotarix og oral polio-vaccine (OPV) påvirker ikke immunresponset overfor de forskellige polio-antigener.
English: The incidence of severe RV gastro-enteritis associated with the individual genotypes was too small to allow calculation of efficacy.
Danish: Forekomsten af alvorlig rotavirus-gastroenteritis associeret med de individuelle genotyper var for lav til at kunne beregne effekten.
English: All RVGE
Danish: Alle RVGE
English: • This vaccine is given orally straight from an individual tube.
Danish: • Vaccinen gives oralt direkte fra en individuel tube.
English: These data should be interpreted with caution # The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very small (1 case in the Rotarix group and 2 cases in the placebo group)
Danish: Disse data skal tolkes med forsigtighed # Meget lille antal tilfælde, hvorpå den estimerede effekt mod G4P[8] er baseret, (1 tilfælde i Rotarixgruppen og 2 tilfælde i placebogruppen)
English: Sustained efficacy up to 3 years of age in Asia
Danish: Disse data skal tolkes med forsigtighed Vedvarende effekt op til 3-års-alderen i Asien
English: • Check the expiry date.
Danish: • Tjek udløbsdatoen
English: There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses or growth retardation.
Danish: Der er ingen data vedrørende sikkerhed og effektivitet af Rotarix hos børn med gastrointestinale gener eller væksthæmning.
English: Transfer adapter for reconstitution (1/dose) in the following pack sizes:
Danish: Overførselsanordning til rekonstituering (1/dosis) i følgende pakningsstørrelser:
English: • 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.
Danish: • han/hun har en sygdom eller får medicin, som nedsætter modstandsdygtigheden over for infektioner, eller hvis hans/hendes mor under graviditeten har taget medicin, der kan svække immunforsvaret.
English: Clinical studies from which efficacy data were derived were conducted in Europe, Central and South America, Africa and Asia (see section 5.1).
Danish: Effektdata kommer fra kliniske studier udført i Europa, Central- og Sydamerika, Afrika og Asien (se pkt.
English: • One oral tube delivers one dose of vaccine.
Danish: • En tube leverer èn vaccinedosis.
English: Administration of Rotarix to infants who have known or suspected immunodeficiency, including in utero exposure to an immunosuppressive treatment, should be based on careful consideration of potential benefits and risks.
Danish: Administration af Rotarix til børn, som har en kendt eller mistænkt immundefektsygdom, herunder eksponering for immunsuppresiv behandling in utero, skal baseres på en nøje overvejelse af potentielle fordele og risici.
English: Rotarix is a clear and colourless liquid.
Danish: Rotarix er en klar og farveløs væske.
English: To open the separated oral tube: d) Keep the separated oral tube held upright.
Danish: Åben den separerede tube: d) Hold den separerede tube opret.
English: 1300 Wavre Belgium
Danish: 1300 Wavre
English: • Turn the cap upside down (180°).
Danish: • Vend tubehætten omvendt (180°).
English: 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.
Danish: Hvis dit barn får Rotarix som første dosis, anbefales det, at dit barn også får Rotarix som anden dosis (og ikke en anden slags rotavirus-vaccine).
English: Oral administration only
Danish: Kun til oral administration
English: Taking into account the PRAC Assessment Report on the PSUR(s) for rotavirus vaccine monovalent (live, oral), the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for rotavirus-vaccine monovalent (levende, oral) er CHMP nået frem til følgende videnskabelige konklusioner:
English: • Keep the cap - you need this to pierce the membrane.
Danish: • Behold hætten - du skal bruge den til at perforere membranen med.
English: • inflammation of the skin
Danish: • betændelse i huden.
English: Withdraw the entire mixture back into the oral applicator
Danish: Træk hele blandingen tilbage i den orale applikator.
English: • You may need to squeeze the tube a few times to get all of the vaccine out - it is okay if a drop remains in the tip of the tube.
Danish: • Det kan være nødvendigt at trykke på tuben flere gange for at få al vaccinen ud - der må gerne være en dråbe tilbage i tuben.
English: Therefore, breast-feeding may be continued during the vaccination schedule.
Danish: Således, kan amning fortsættes under vaccinationsprogrammet.
English: Contacts of recent vaccinees should observe personal hygiene (e.g. wash their hands after changing child's nappies).
Danish: Personer i kontakt med nylig vaccinerede børn skal rådes til at opretholde god personlig hygiejne (f.eks. vaske deres hænder efter bleskift).
English: There are no data on the use of Rotarix during pregnancy and lactation.
Danish: Der findes ingen data for anvendelse af Rotarix under graviditet og amning.
English: Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy of Rotarix.
Danish: Hiv-infektioner uden eller med milde symptomer forventes ikke at have indvirkning på sikkerheden eller effekten af Rotarix.
English: * In these studies, the point estimates and confidence intervals were respectively: 100% (95% CI:1,858.0;100), 100% (95% CI: 21.1;100), 45.4% (95% CI: -81.5;86.6), 74.7 (95% CI :-386.2;99.6).
Danish: *I disse studier var punktestimater og konfidensintervaller henholdsvis: 100 % (95 % CI: -1.858,0; 100), 100 % (95 % CI: 21,1; 100), 45,4 % (95 % CI: -81,5; 86,6), 74,7 (95 % CI: -386,2; 99,6).
English: See the package leaflet for further information
Danish: Læs indlægssedlen for yderligere information
English: A clinical study performed in Latin America evaluated Rotarix in more than 20,000 subjects.
Danish: Der er blevet udført et klinisk studie med Rotarix i Latinamerika, som involverede mere end 20.000 personer.
English: If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, contact your doctor before receiving this vaccine.
Danish: Hvis din læge har fortalt, at dit barn ikke kan tåle visse sukkerarter, skal du kontakte din læge, inden dit barn bliver vaccineret.
English: Clinical protection was assessed in the ATP cohort for efficacy, which includes all subjects from the ATP cohort for safety who entered into the concerned efficacy follow-up period.
Danish: Den kliniske beskyttelse blev vurderet i ATP (according to protocol)-kohorten for effekt, som inkluderede alle børn fra ATP-kohorten for sikkerhed, som deltog i den pågældende opfølgningsperiode for effekt.
English: A clinical study in a limited number of asymptomatic or mildly symptomatic HIV positive infants showed no apparent safety problems (see section 4.8).
Danish: Et klinisk studie med et begrænset antal hiv-positive børn uden eller med lette symptomer viste ikke tydelige tegn på øget risiko (se pkt.
English: Administration of Rotarix may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.
Danish: Administration af Rotarix til sådanne børn skal ske med omtanke, hvis det efter lægens mening udgør en større risiko ikke at give vaccinen.
English: The doctor or nurse will administer the recommended dose of Rotarix to your child.
Danish: Lægen eller sygeplejersken vil give dit barn den anbefalede dosis Rotarix.
English: • This vaccine is given orally - straight from the tube.
Danish: • Denne vaccine skal administreres oralt - direkte fra tuben.
English: • blood in stools
Danish: • blod i afføringen
English: There are no restrictions on the infant's consumption of food or liquid, either before or after vaccination.
Danish: Der er ingen restriktioner med hensyn til, hvad barnet må få af mad eller væske hverken før eller efter vaccination.
English: • abdominal pain (see also below for signs of very rare side effects of intussusception)
Danish: • mavesmerter (se også nedenfor angående symptomer på invagination, som er en meget sjælden bivirkning)
English: Rotarix is not intended for use in adults.
Danish: Rotarix er ikke beregnet til voksne.
English: Severe†
Danish: Alvorlig†
English: 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.
Danish: I et klinisk studie i Europa blev Rotarix undersøgt og givet i overensstemmelse med forskellige europæiske programmer (2, 3 måneder; 2, 4 måneder; 3, 4 måneder; 3, 5 måneder) til 4.000 personer.
English: No cases of intussusception were reported.
Danish: Der sås ikke tilfælde af invagination.
English: Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus.
Danish: Rotarix beskytter ikke mod gastroenteritis forårsaget af andre patogener end rotavirus.
English: Immune response in preterm infants
Danish: Immunrespons hos præmature børn
English: The signs may include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever.
Danish: Symptomerne kan være alvorlige mavesmerter, vedvarende opkastning, blod i afføringen, opsvulmet mave og/eller høj feber.
English: Instructions for reconstitution and administration of the vaccine:
Danish: Instruktioner for rekonstituering og administration af vaccinen:
English: • if your child has diarrhoea or is vomiting.
Danish: • hvis dit barn har diaré eller kaster op.
English: In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given.
Danish: Der er kun sjældent observeret spytning eller gylp af vaccinen i de kliniske studier, og i disse tilfælde blev der ikke givet en erstatningsdosis.
English: Check the expiry date on the connecting bar. 2.
Danish: Tjek udløbsdatoen på den sammenhængende plade.
English: The vaccine should be used immediately after opening.
Danish: Vaccinen skal gives straks efter åbning.
English: Dispose of in accordance with local regulations.
Danish: Bortskaffes i henhold til lokale retningslinjer.
English: Middle Income Countries
Danish: Mellemindkomstlande
English: What to do if the membrane has not been pierced
Danish: Hvis membranen ikke er blevet perforeret