FrancophonIA/ELRC3.0 huggingface dataset:
English: Study design (Region)
Danish: Studiedesign (region)
English: As always, please take care to wash your hands thoroughly after changing soiled nappies.
Danish: Som altid skal man være omhyggelig med at vaske hænderne grundigt efter at have skiftet brugte bleer.
English: If the problem recurs, additional replacement doses should not be given.
Danish: Hvis problemet gentager sig, bør der ikke gives yderligere erstatningsdoser.
English: Date of first authorisation: 27 June 2006
Danish: Dato for første markedsføringstilladelse: 27. juni 2006
English: There is limited evidence of a smaller increased risk following the second dose.
Danish: Der er begrænset evidens for en mindre øget risiko efter den anden dosis.
English: In the general safety analyses, no specific safety concerns were identified.
Danish: De generelle sikkerhedsanalyser viste ingen særlige sikkerhedsrisici.
English: The vaccination course consists of three doses.
Danish: Vaccinationsforløbet består af tre doser.
English: Co-administration resulted in an acceptable safety profile.
Danish: Samtidig indgivelse resulterede i en acceptabel sikkerhedsprofil.
English: Efficacy in premature infants
Danish: Effekt hos præmature spædbørn
English: Sumneytown Pike - PO Box 4 - West Point - Pennsylvania 19486
Danish: Sumneytown Pike - Postboks 4 - West Point - Pennsylvania 19486
English: Study population
Danish: Studiepopulation
English: 4.8 Undesirable effects a. Summary of the safety profile
Danish: 4.8 Bivirkninger a. Oversigt over sikkerhedsprofilen
English: 2,102 unvaccinated Aged <2 years
Danish: 2.102 ikke-vaccinerede Alder <2 år
English: Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data)
Danish: Meget almindelig (≥1/10); Almindelig (≥1/100 til <1/10); Ikke almindelig (≥1/1.000 til <1/100); Sjælden (≥1/10.000 til <1/1.000); Meget sjælden (< 1/10.000), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If you forget or are not able to go back to your doctor/health care professional at the scheduled time, ask him or her for advice.
Danish: Hvis du glemmer eller ikke er i stand til at møde hos din læge/sundhedsplejerske på det aftalte tidspunkt, så spørg ham eller hende til råds.
English: Overall, 31 % and 25 % of the encounters in the respective groups occurred during the FES.
Danish: Generelt opstod 31 % og 25 % af lægebesøgene i de respektive grupper i løbet af FES.
English: The dose administered to mice was approximately 2.79 x 10
Danish: Den dosis, der blev givet til mus, var ca. 2,79 x 10
English: 1 dose (2 ml)
Danish: 1 dosis (2 ml)
English: Infectious Units As lower confidence limit (p = 0.95)
Danish: Infektiøse enheder Som nedre konfidensgrænse (p= 0,95)
English: There was an extension of REST conducted in Finland only.
Danish: Der er blevet udført en forlængelse af REST-studiet, men kun i Finland.
English: The following information is intended for health care professionals only:
Danish: Nedenstående oplysninger er til læger og sundhedspersonale:
English: Age-specific - 1st year of life - 2nd year of life - 3rd year of life - 4th year of life - 5th year of life - 6th-7th year of life
Danish: Aldersspecifik - 1. leveår - 2. leveår - 3. leveår - 4. leveår - 5. leveår - 6.-7. leveår
English: 1,895 vaccinated with 3 doses
Danish: 1.895 vaccinerede Fik 3 doser
English: Read all of this leaflet carefully before your child is vaccinated because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden dit barn vaccineres, da den indeholder vigtige oplysninger.
English: See also section 3.
Danish: Se også punkt 3.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Danish: Da fordelen ved vaccination er stor for denne gruppe af spædbørn, bør vaccination ikke undlades eller udsættes.
English: There should be intervals of at least 4 weeks between doses.
Danish: Der skal være mindst 4 uger mellem doserne.
English: Store in a refrigerator (2 °C to 8 °C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: Open the dosing tube in 2 easy motions:
Danish: Åbn doseringstuben i 2 enkle bevægelser:
English: • Not known (frequency cannot be estimated from the available data): irritability
Danish: • Ikke kendt (hyppigheden kan ikke vurderes ud fra forhåndenværende data): irritabilitet.
English: FOR ORAL USE ONLY Read the package leaflet before use
Danish: KUN TIL ORAL ANVENDELSE Læs indlægssedlen inden brug.
English: Contact a doctor/health care professional right away if your child experiences one of the following symptoms:
Danish: Kontakt straks en læge/sundhedsplejerske, hvis dit barn får et af følgende symptomer:
English: 402 cases 2,559 controls* Aged <8 years Received 3 doses
Danish: 402 tilfælde 2.559 kontroller* Alder <8 år Fik 3 doser
English: 33,140 vaccinated 26,167 unvaccinated Aged ≥7 months Received 3 doses
Danish: 33.140 vaccinerede 26.167 ikke-vaccinerede Alder ≥7 måneder Fik 3 doser
English: The efficacy observed against G2P[4] most likely resulted from the G2 component of the vaccine.
Danish: Effekten, der blev observeret imod G2P[4], skyldtes mest sandsynligt G2komponenten i vaccinen.
English: Thus human data on use during pregnancy or lactation are not available and animal fertility or reproduction studies have not been performed.
Danish: Der findes derfor ikke data for human anvendelse under graviditet eller amning, og der er ikke gennemført fertilitets- og reproduktionsstudier hos dyr.
English: Clinical trials of efficacy against rotavirus gastroenteritis were performed in Europe, the United States, Latin America, and Asia.
Danish: Der er udført kliniske studier med virkningen mod rotavirus-gastroenteritis i Europa, USA, Latinamerika og Asien.
English: It is important that you follow the instructions of your doctor/health care professional regarding your child's return visits for the follow-up doses.
Danish: Det er vigtigt, at du følger din læges/sundhedsplejerskes instruktioner vedrørende dit barns konsultationer for opfølgende doser.
English: It is important that your child receives all 3 doses of the vaccine for protection against rotavirus.
Danish: Det er vigtigt, at dit barn får alle 3 doser af vaccinen for at opnå maksimal beskyttelse imod rotavirus.
English: 8 infectious units per kg (about 14-fold the projected infant dose).
Danish: 8 infektiøse enheder pr. kg (ca. 14 gange den beregnede dosis til spædbørn).
English: - your child has any disease which reduces his/her resistance to infection.
Danish: Hvis dit barn har en sygdom, som reducerer dets modstandskraft imod infektioner.
English: Ask your doctor/health care professional if you want more information about side effects for RotaTeq.
Danish: Spørg din læge/sundhedsplejerske, hvis du ønsker flere oplysninger om bivirkningerne ved RotaTeq.
English: There are no restrictions on taking food or liquid, including breast milk, either before or after vaccination with RotaTeq.
Danish: Der er ingen begrænsninger for indtagelse af mad eller væske, herunder modermælk, før eller efter vaccination med RotaTeq.
English: Parents/guardians should be advised to promptly report such symptoms to their healthcare provider.
Danish: Forældre/værger skal informeres om omgående at indberette sådanne symptomer til lægen eller sundhedspersonalet.
English: The frequency category was estimated based on observational study data.
Danish: Hyppigheden er estimeret på baggrund af data fra observationsstudier.
English: RV seasons
Danish: RV-sæson
English: - 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.
Danish: har en tæt kontakt, f.eks. med et medlem af husstanden, der har svækket immunsystem, f.eks. en person med cancer, eller en person, der tager lægemidler, der kan svække immunsystemet.
English: Data from observational safety studies performed in several countries indicate that rotavirus vaccines carry an increased risk of intussusception, with up to 6 additional cases per 100,000 infants within 7 days of vaccination.
Danish: Data fra observationelle sikkerhedsstudier udført i adskillige lande tyder på, at rotavirus-vacciner medfører en øget risiko for invagination med op til 6 yderligere tilfælde pr. 100.000 spædbørn inden for 7 dage efter vaccination.
English: If you have been told that your child has an intolerance to some sugars, inform your doctor/health care professional before the vaccine is administered.
Danish: Hvis du har fået at vide, at dit barn har en intolerans over for visse typer sukker, skal du underrette din læge/sundhedsplejerske, før vaccinen indgives.
English: The background incidence of intussusception in infants less than one year of age in these countries ranged from 25 to 101 per 100,000 infants per year.
Danish: Baggrundsincidensen af invagination hos spædbørn under et år i disse lande varierede fra 25 til 101 pr. 100.000 spædbørn pr. år.
English: Uncommon Nasopharyngitis, otitis media
Danish: Ikke almindelig Nasopharyngitis, otitis media
English: The vaccine is to be administered orally without mixing with any other vaccines or solutions.
Danish: Vaccinen skal indgives oralt uden opblanding med andre vacciner eller opløsninger.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: This adverse reaction was identified through post-marketing surveillance.
Danish: Denne bivirkning blev identificeret via bivirkningsovervågningen efter markedsføring.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Text for the protective bag
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Tekst til beskyttelsesposen
English: Post-marketing adverse events (frequency cannot be estimated from the available data).
Danish: Bivirkninger efter markedsføringen (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: Asymptomatic HIV infection is not expected to affect the safety or efficacy of RotaTeq.
Danish: Asymptomatisk HIV-infektion forventes ikke at påvirke sikkerheden eller effekten af RotaTeq.
English: In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må denne vaccine ikke blandes med andre lægemidler.
English: If your child has already been infected with rotavirus but is not yet ill when vaccinated, RotaTeq may not be able to prevent the illness.
Danish: Hvis dit barn allerede er smittet med rotavirus, men endnu ikke er sygt, når det vaccineres, vil RotaTeq måske ikke være i stand til at forhindre sygdommen.
English: Culture media (containing inorganic salts, amino acids and vitamins) Purified water
Danish: Dyrkningsmedie (indeholdende uorganiske salte, aminosyrer og vitaminer) Renset vand
English: A doctor or nurse will administer the recommended doses of RotaTeq to your child.
Danish: En læge eller sygeplejerske vil give de anbefalede doser af RotaTeq til dit barn.
English: Effectiveness study data Post marketing studies demonstrating effectiveness to prevent RV gastroenteritis (RVGE)
Danish: Data fra effektivitetsstudier Post marketing-studier, der viser effektivitet ved forebyggelse af RV-gastroenteritis (RVGE)
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The presence of a minor infection is not a contraindication for immunisation.
Danish: Forekomst af mild infektion er ikke en kontraindikation for vaccination.
English: During the 0-30 day follow-up period after vaccination, there were no statistically significant difference in the rate of Kawasaki disease compared with the expected background rate.
Danish: I opfølgningsperioden 0-30 dage efter vaccination blev der ikke konstateret statistisk signifikant forskel i hyppighed af Kawasakis sygdom sammenlignet med de forventede baggrundshyppigheder.
English: *RV-negative acute gastroenteritis controls
Danish: *Kontrolgruppe med RV-negativ akut gastroenteritis
English: A single and repeated dose oral toxicity study in mice suggests no special hazard to humans.
Danish: Et toksicitetsstudie med mus med enkelt og gentaget dosis tyder ikke på nogen særlig risiko for mennesker.
English: • Allergic reactions (frequency cannot be estimated from the available data), which may be severe (anaphylaxis), and may include: allergic swelling that may affect the face, lips, tongue or throat.
Danish: • Allergiske reaktioner (hyppigheden kan ikke vurderes ud fra forhåndenværende data), som kan være alvorlige (anafylaksi), og som kan omfatte: allergisk hævelse som kan påvirke ansigt, læber, tunge eller svælg.
English: Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
Danish: Denne vaccine kan som alle andre vacciner og al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Also, those caring for recent vaccinees should observe careful hygiene especially when handling excreta.
Danish: Personer, der passer nyvaccinerede, skal være omhyggelig med hygiejnen særligt ved håndtering af ekskreter.
English: RotaTeq SHOULD UNDER NO CIRCUMSTANCES BE INJECTED.
Danish: RotaTeq MÅ UNDER INGEN OMSTÆNDIGHEDER INJICERES.
English: The additional data from the FES increased the number by 136 encounters in total, including 9 in the vaccine group and 127 in the placebo group.
Danish: Med de yderligere data fra FES steg dette antal med i alt 136 lægebesøg, herunder 9 i vaccinegruppen og 127 i placebogruppen.
English: * Severe defined as a score >16/24 using a validated clinical scoring system based on the intensity and duration of symptoms (fever, vomiting, diarrhoea and behavioural changes) Statistically significant
Danish: * Svær sygdom defineret som en score >16/24 med et valideret klinisk scoresystem, baseret på symptomernes (feber, opkastning, diarré og adfærdsændringer) intensitet og varighed Statistisk signifikant
English: These infants should receive the first dose of vaccine between 6 and 12 weeks after birth.
Danish: Disse spædbørn skal have den første dosis af vaccinen mellem 6 og 12 uger efter fødslen.
English: This may present as wheezing, coughing or difficulty breathing.
Danish: Dette kan vise sig som hvæsende vejrtrækning, hoste eller vejrtrækningsbesvær.
English: In addition, there was no statistically significant increased risk of this adverse event during the 0-30 day follow-up period compared with a concurrent control group of infants who received DTaP, but not RotaTeq (n=62,617, 12,339 person-years of follow-up).
Danish: Ydermere var der ingen statistisk signifikant øget risiko for disse bivirkninger i opfølgningsperioden på 0-30 dage sammenlignet med en sideløbende kontrolgruppe med spædbørn, som fik DTaP, men ikke RotaTeq (n=62.617, 12.339 personårs opfølgning).
English: RotaTeq is to be used on the basis of official recommendations.
Danish: RotaTeq skal anvendes på basis af de officielle anbefalinger.
English: Sodium dihydrogen phosphate monohydrate Sodium hydroxide
Danish: Natriumdihydrogenphosphatmonohydrat Natriumhydroxid
English: The most commonly reported adverse reactions that occurred more frequently with vaccine than with placebo were pyrexia (20.9 %), diarrhoea (17.6 %) and vomiting (10.1 %).
Danish: De hyppigst indberettede bivirkninger, der forekom hyppigere ved vaccine end ved placebo, var pyreksi (20,9 %), diarré (17,6 %) og opkastning (10,1 %).
English: It is preferable that the vaccination course of three doses should be completed by the age of 20-22 weeks.
Danish: Det er at foretrække, at vaccinationsforløbet på tre doser afsluttes før 20-22-ugers-alderen.
English: To administer the vaccine:
Danish: Indgivelse af vaccinen:
English: The level of protection provided by RotaTeq is based on the completion of all 3 doses.
Danish: RotaTeqs beskyttelsesniveau er baseret på gennemførelse af alle 3 doser.
English: 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.
Danish: 19 ud af de cirka 1.000 spædbørn fødtes imidlertid ved en gestationsalder på 25 til 28 uger, 55 fødtes ved en gestationsalder på 29 til 31 uger, og resten fødtes ved en gestationsalder på mellem 32 og 36 uger.
English: EU/1/06/348/001 pack of 1 tube EU/1/06/348/002 pack of 10 tubes
Danish: EU/1/06/348/001 pakning med 1 tube EU/1/06/348/002 pakning med 10 tuber
English: If necessary, the third (last) dose may be given up to the age of 32 weeks (see section 5.1).
Danish: Om nødvendigt kan den tredje (sidste) dosis gives op til 32-ugers-alderen (se pkt.
English: The frequency category was estimated based on relevant clinical trials.
Danish: Hyppigheden er estimeret på baggrund af relevante kliniske studier.
English: Case-control study (US)
Danish: Case-kontrolstudie (USA)
English: No immunological correlate of protection has currently been identified for rotavirus vaccines.
Danish: Intet immunologisk korrelat for beskyttelse er i øjeblikket identificeret for rotavirus-vacciner.
English: As with all vaccines, appropriate medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine (see section 4.8).
Danish: Som ved alle vacciner skal passende lægebehandling altid være lettilgængelig i tilfælde af en anafylaktisk hændelse i forbindelse med administration af vaccinen (se pkt.
English: The first dose (2 ml) of RotaTeq may be given from the age of 6 weeks and should be given before 12 weeks of age (about 3 months).
Danish: Den første dosis (2 ml) af RotaTeq kan gives fra 6-ugers-alderen, og bør gives før 12-ugers-alderen (omkring 3 måneder).
English: The overall frequency of these serious adverse reactions was 0.1 % among recipients of RotaTeq and 0.2 % among placebo recipients.
Danish: Den samlede frekvens for disse alvorlige bivirkninger var 0,1 % blandt modtagere af RotaTeq og 0,2 % blandt modtagere af placebo.
English: See section 6.6 for administration instructions.
Danish: 6.6 for anvisninger vedrørende indgivelsen.
English: • Severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever.
Danish: • Svære mavesmerter, vedvarende opkastning, blod i afføringen, opsvulmet mave og/eller høj feber.
English: Under no circumstance should this vaccine be administered by injection.
Danish: Denne vaccine må under ingen omstændigheder indgives ved injektion.
English: Adverse reactions more common in the vaccine group in clinical trials are listed below per system organ class and frequency.
Danish: Bivirkninger, der var mere almindelige i vaccinegruppen i kliniske studier, er anført herunder inddelt efter organklasse og hyppighed.
English: 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.
Danish: Hos børn, der er født meget for tidligt (i løbet af eller før 28. svangerskabsuge) kan der opstå længere pauser i vejrtrækningen end normalt, dette kan ske i 2-3 dage efter vaccination.
English: Safety or efficacy data are not available for infants with active gastrointestinal illnesses (including chronic diarrhoea) or growth retardation.
Danish: Der findes ikke sikkerheds- og virkningsdata for spædbørn med aktiv, gastrointestinal sygdom (herunder kronisk diarré) eller hæmmet vækst.
English: (A residual drop may remain in the tip of the tube.)
Danish: (Der kan være en dråbe tilbage i tubespidsen).
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: Det er fortsat uvist, hvorvidt rotavirus-vacciner påvirker den samlede incidens af invagination baseret på længere opfølgningsperioder (se pkt.
English: tube label
Danish: Tubeetiket
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: It is preferred that all three doses should be given by the age of 20-22 weeks and at latest all three doses should be given by the age of 32 weeks.
Danish: Det er at foretrække, at alle tre doser gives før 20-22-ugers-alderen, og alle tre doser skal senest være givet ved 32-ugers-alderen.
English: Claims database analysis (US)
Danish: Analyse af skadesdatabase (USA)
English: 6 Infectious Units
Danish: 6 Infektiøse enheder
English: - your child developed an allergic reaction after receiving a dose of RotaTeq or other rotavirus vaccine.
Danish: Hvis dit barn udviklede en allergisk reaktion efter at have fået en dosis RotaTeq eller anden rotavirus-vaccine.
English: These could be symptoms of a very rare (may affect up to 1 in 10,000 infants), but serious, side effect called intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).
Danish: Disse kan være symptomer på en meget sjælden (kan forekomme hos op til 1 ud af 10.000 spædbørn) men alvorlig bivirkning kaldet invagination (tarmobstruktion hvor et stykke af tarmen bliver foldet ind i et andet tarmstykke).
English: During year 3, there were no health care contacts for RV gastroenteritis in the vaccine group (n=3,112) and one (non-typeable) in the placebo group (n=3,126).
Danish: I løbet af år 3 var der ingen kontakt med sundhedsvæsenet på grund af rotavirus-gastroenteritis i vaccinegruppen (n=3.112) og et (som ikke kunne typebestemmes) i placebogruppen (n=3.126).
English: As with other vaccines, RotaTeq may not completely protect all children who are vaccinated even after all three doses have been given.
Danish: Som alle andre vacciner beskytter RotaTeq måske ikke alle vaccinerede børn fuldstændigt, selv ikke efter at alle tre doser er blevet givet.
English: RotaTeq should be administered promptly after removal from refrigeration.
Danish: RotaTeq skal indgives med det samme, efter den er blevet taget ud af køleskabet.
English: - your child is allergic to any of the components of this vaccine (see section 6 Contents of the pack and other information).
Danish: Hvis dit barn er allergisk over for et eller flere af vaccinens hjælpestoffer (se punkt 6 Pakningsstørrelser og yderligere oplysninger).
English: These antibodies help protect against gastroenteritis caused by these types of rotavirus.
Danish: Disse antistoffer hjælper med at beskytte imod gastroenteritis, der skyldes disse typer af rotavirus.
English: Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, The Netherlands
Danish: Fremstiller med ansvar for batchfrigivelse: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, Holland
English: This vaccine is contained in a single-dose tube and is a pale yellow clear liquid that may have a pink tint.
Danish: Denne vaccine leveres i en enkeltdosistube og er en lysegul, klar væske, der kan have et lyserødt skær.
English: The first dose was administered from 6 weeks after birth.
Danish: Den første dosis blev givet fra 6 uger efter fødslen.