FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack size of 1, 10 or 50.
Danish: Pakningsstørrelse på 1, 10 eller 50.
English: Convulsions (including febrile convulsions)
Danish: Kramper (inklusive feberkramper)
English: HIV positive (HIV+/+) infants and HIV negative infants born from HIV positive mothers (HIV+/-)
Danish: Hiv-positive spædbørn (hiv +/+) og hiv-negative spædbørn født af hiv-positive mødre (hiv +/-)
English: The first dose may be given as early as 6 weeks of age.
Danish: Den første dosis kan gives så tidligt som i 6-ugers alderen.
English: If a vaccine dose is withdrawn into a syringe for injection, the needle used for withdrawal must be replaced by a needle suitable for intramuscular injection.
Danish: Hvis en vaccinedosis trækkes op i injektionssprøjten til brug for administration, skal den anvendte kanyle udskiftes med en ny kanyle til brug for intramuskulær injektion.
English: Unvaccinated infants and children ≥ 7 months of age
Danish: Ikke vaccinerede spædbørn og børn i alderen ≥ 7 måneder
English: The first dose may be given as early as 6 weeks of age with a second dose administered 2 months later.
Danish: Den første dosis kan gives så tidligt som i 6-ugers alderen, efterfulgt af en dosis der administreres 2 måneder senere.
English: However, children who received 7-valent Prevenar for the primary series would not be primed against the additional serotypes contained in Synflorix (1, 5, 7F).
Danish: Børn, som har fået 7-valent Prevenar, har dog ikke fået den primære beskyttelse mod de ekstra serotyper i Synflorix (1, 5, 7F).
English: The results for protein D suggested comparable post-primary and post-booster immune responses between groups.
Danish: Resultaterne for protein D viste sammenlignelige immunrespons efter primærvaccination og boosterdosis mellem grupperne.
English: This study has shown that the immune responses against the 7 common serotypes were comparable to those elicited by a booster dose of 7-valent Prevenar.
Danish: Dette studie har vist, at immunresponset mod de syv fælles serotyper var sammenligneligt med det respons, som blev opnået efter en boosterdosis af 7-valent Prevenar.
English: Following booster vaccination, the most common adverse reactions were pain at the injection site and irritability, which occurred at approximately 51% and 53% respectively.
Danish: Efter boostervaccination var de hyppigste bivirkninger smerte på administrationsstedet og irritabilitet, som blev observeret hos hhv. ca. 51 % og 53 %.
English: Usually, your child (from 6 weeks to 6 months of age) will receive a course of 4 injections according to official recommendations or an alternative schedule may be used by the health care professional.
Danish: Dit barn (i alderen fra 6 uger til 6 måneder) vil sædvanligvis følge et vaccinationsprogram med 4 indsprøjtninger i henhold til de officielle retningslinjer, men lægen kan også vælge at følge et andet vaccinationsprogram.
English: After first opening of multidose vial:
Danish: Efter anbrud af flerdosisbeholder:
English: • unusual crying
Danish: Unormal gråd
English: 1-dose and 2-dose containers 4 years
Danish: 1-dosis og 2-dosis beholder 4 år
English: Different injectable vaccines should always be given at different injection sites.
Danish: De forskellige injicerbare vacciner skal altid administreres på forskellige administrationssteder.
English: It is also recommended to administer a medicine that lowers fever in children with convulsion disorders or with prior history of febrile convulsions.
Danish: Det anbefales også at administrere et lægemiddel, der nedsætter feber hos børn med kramper eller som tidligere har haft feberkramper.
English: Two efficacy studies, COMPAS and POET (Pneumococcal Otitis Media Efficacy Trial), were conducted with pneumococcal conjugate vaccines containing protein D: Synflorix and an investigational 11-valent conjugate vaccine (which in addition contained serotype 3), respectively.
Danish: To virkningsstudier, COMPAS og POET (Pneumococcal Otitis Media Efficacy Trial) blev udført med konjugerede pneumokokvacciner indeholdende protein D: henholdsvis Synflorix og en konjugeret 11valent testvaccine (som yderligere indeholdt serotype 3).
English: 1 microgram
Danish: 1 mikrogram
English: Following catch-up vaccination in children 12 to 23 months of age, urticaria was reported more frequently (uncommon) compared to the rates observed in infants during primary and booster vaccination.
Danish: Efter et opfølgningsprogram hos børn i alderen 12-23 måneder blev urticaria set oftere (hyppighed: ikke almindelig) sammenlignet med hyppigheden observeret hos spædbørn under det primære vaccinationsprogram og boostervaccination.
English: Control schedule
Danish: Kontrol program
English: If Synflorix is co-administered with other vaccines, different injection sites should be used.
Danish: Hvis Synflorix administreres samtidigt med andre vacciner, skal der anvendes forskellige administrationssteder.
English: It is not known whether the reduction in antibody levels has an impact on the protection against pneumococcal disease.
Danish: Det vides ikke, om det lidt lavere niveau af antistoffer har nogen indflydelse på, hvor godt dit barn er beskyttet mod pneumokok-sygdom.
English: In the event of either being observed, discard the vaccine.
Danish: I tilfælde af observation af et af de ovennævnte forhold skal vaccinen kasseres.
English: Table 1: Number of vaccine serotype IPD cases and vaccine effectiveness (FinIP) or efficacy (COMPAS) in infants below 7 months of age at enrolment receiving at least one vaccine dose (Infant total vaccinated cohort)
Danish: Tabel 1: Antal IPD-tilfælde forårsaget af vaccineserotyper samt vaccine-effektivitet (FinIP) eller vaccine-virkning (COMPAS) hos børn i alderen under 7 måneder ved indskrivning, som fik mindst en vaccinedosis (kohorte af alle vaccinerede spædbørn)
English: Read the package leaflet before use Intramuscular use
Danish: Læs indlægssedlen inden brug Intramuskulær anvendelse
English: There are no data available to indicate whether the administration of pneumococcal polysaccharide vaccine to Synflorix primed children may result in hyporesponsiveness to further doses of pneumococcal polysaccharide or to pneumococcal conjugate vaccine.
Danish: Der findes ingen tilgængelige data for, om administration af pneumokokpolysaccharidvaccine til børn, der er immuniseret med Synflorix, kan resultere i mindre modtagelighed over for yderligere doser af pneumokokpolysaccharid eller konjugeret pneumokokvaccine.
English: Among the 15,447 children in the catch-up vaccinated cohorts, there were no culture-confirmed IPD cases in the Synflorix groups while 5 vaccine serotype IPD cases were observed in the control groups (serotypes 4, 6B, 7F, 14 and 19F).
Danish: Blandt de 15.447 børn i catch-up-vaccineret-kohorterne blev der ikke fundet kulturbekræftet IPDtilfælde i Synflorix-grupperne, mens der blev observeret 5 tilfælde af IPD forårsaget af vaccineserotyper i kontrolgrupperne (serotype 4, 6B, 7F, 14 og 19F).
English: which will be given at least 6 months after the third injection.
Danish: (booster), som skal gives mindst 6 måneder efter tredje indsprøjtning.
English: In both schedules, a booster response indicative of immunological priming was observed for each vaccine serotype (Table 7 and Table 8).
Danish: For begge programmer indikerede boosterresponset immunologisk priming for alle vaccineserotyper (tabel 7 og 8).
English: The vaccine should be given by intramuscular injection.
Danish: Vaccinen skal gives som intramuskulær injektion.
English: Immunogenicity data in preterm infants
Danish: Immunogenicitetsdata hos præmature spædbørn
English: In addition, as otitis media and pneumonia are caused by many microorganisms other than the Streptococcus pneumoniae serotypes represented by the vaccine, the overall protection against these diseases is expected to be limited and substantially lower than protection against invasive disease caused by the serotypes in the vaccine and serotype 19A (see section 5.1).
Danish: Ydermere kan otitis media og pneumoni skyldes mange andre mikroorganismer end de Streptococcus pneumoniae-serotyper, som repræsenteres af vaccinen, og den totale beskyttelse mod disse sygdomme forventes at være begrænset og væsentligt lavere end beskyttelsen mod invasive sygdomme forårsaget af serotyperne i vaccinen og serotype 19A (se pkt.
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: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelargentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The implications of these findings for protective efficacy are not known.
Danish: Betydningen af disse observationer for beskyttelseseffekten er ikke kendt.
English: It is recommended that subjects who receive a first dose of Synflorix complete the full vaccination course with Synflorix.
Danish: Det anbefales, at personer, der får den første dosis i et vaccinationsprogram med Synflorix, gennemfører hele vaccinationsprogrammet med Synflorix.
English: Any vaccine serotype IPD(3) - Invasive pneumonia or bacteraemia - Meningitis
Danish: Alle IPD vaccineserotyper(3) - Invasiv pneumoni eller bakteriæmi - Meningitis
English: Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines, or if they have recently received any other vaccine.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis dit barn får anden medicin, eller har fået det for nylig, eller hvis dit barn fornylig har fået en anden vaccine.
English: In both COMPAS and the nested Finnish study, Synflorix reduced vaccine type carriage with an apparent increase in non-vaccine (excluding vaccine-related) serotypes observed after booster.
Danish: I både COMPAS og det finske understudie reducerede Synflorix bærertilstanden af vaccinetyperne med en mulig stigning i bærertilstanden af ikke-vaccine (eksklusive vaccinerelaterede) serotyper efter booster.
English: Alternatively, when Synflorix is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5 ml may be given.
Danish: Hvis Synflorix gives som en del af et rutinemæssigt vaccinationsprogram til spædbørn, kan der alternativt gives en serie på 3 doser, hver på 0,5 ml.
English: The use of prophylactic antipyretic medicinal products is recommended: - for all children receiving Synflorix simultaneously with vaccines containing whole cell pertussis because of higher rate of febrile reactions (see section 4.8).
Danish: Det anbefales at anvende profylaktiske antipyretika: - til alle børn, der får Synflorix samtidig med vacciner, som indeholder helcelle-pertussis pga. større frekvens af febrile reaktioner (se pkt.
English: Infants from 6 weeks to 6 months of age
Danish: Spædbørn i alderen fra 6 uger til 6 måneder
English: A clinical study conducted in Burkina Faso assessed the immunogenicity of Synflorix administered to 146 children with SCD (haemoglobin SS disease, haemoglobin SC disease or with β-thalassemia) compared to 143 age-matched children without SCD.
Danish: Et klinisk studie udført i Burkina Faso vurderede Synflorix's immunogenicitet ved administration til 146 børn med SCD (hæmoglobin SS sygdom, hæmoglobin SC sygdom eller med β-thalassæmi) sammenlignet med 143 børn i den samme alder uden SCD.
English: Overall, the persistence of the immune response until the booster at 11 months of age was lower in the 2-dose primed subjects.
Danish: Generelt var persistensen af immunresponset indtil boostervaccinationen ved 11-måndersalderen lavere i 2-dosis-gruppen.
English: Based on immunological bridging of the functional vaccine response (OPA) of Synflorix with the 11-valent formulation used within POET, it is expected that Synflorix provides similar protective efficacy against pneumococcal AOM.
Danish: Ud fra en immunologisk ekstrapolation af det funktionelle vaccinerespons (OPA) af Synflorix med 11valent-formuleringen, som blev anvendt i POET-studiet, forventes det, at Synflorix har tilsvarende effekt ved beskyttelse mod AOM, der er forårsaget af pneumokokker.
English: Children with splenic dysfunction
Danish: Børn med dysfunktion af milten
English: Very common Irritability Uncommon Crying abnormal
Danish: Meget almindelig Irritabilitet Ikke almindelig
English: Children from 6 weeks up to 5 years of age considered to be at a higher risk of pneumococcal infection (such as those with HIV infection, sickle cell disease or impaired or abnormal functioning of the spleen) may receive Synflorix.
Danish: Børn fra 6 uger og op til 5 år, som vurderes at have en høj risiko for at få en infektion med pneumokokbakterier (f.eks. børn med hiv-infektion, seglcellesygdom eller med nedsat eller unormal funktion af milten), må få Synflorix.
English: Post-marketing experience Immune system disorders
Danish: Erfaringer efter markedsføring Immunsystemet
English: Your doctor or nurse will inject your child with this vaccine.
Danish: Lægen eller sygeplejersken giver vaccinen som en indsprøjtning til dit barn.
English: Although there was no significant difference between the two groups in the percentages of subjects with antibody concentration ≥ 0.20 µg/ml (ELISA), the percentages of subjects for serotypes 6B and 23F were lower than for the other vaccine serotypes (Table 7 and Table 8).
Danish: Selvom der ikke var signifikant forskel i procentdelen af børn med antistofkoncentrationer ≥ 0,20 μg/ml (ELISA) mellem de to grupper, var procentdelen lavere for serotyperne 6B og 23F end for de andre vaccineserotyper (tabel 7 og 8).
English: The clinical relevance of these differences is not known.
Danish: Den kliniske relevans af disse forskelle er ikke kendt.
English: Additional immunogenicity data
Danish: Yderligere immunogenicitetsdata
English: Safety of Synflorix was also assessed in 50 children with SCD starting vaccination at 7-11 months of age, all of them receiving the booster vaccination, and in 50 children with SCD starting vaccination at 12-23 months of age.
Danish: Sikkerhed for Synflorix blev også vurderet hos 50 børn med SDC, som startede vaccinationen i alderen 7-11 måneder, og de modtog alle en booster vaccination, og det blev vurderet hos 50 børn med SCD som startede vaccinationen i alderen 12-23 måneder.
English: It is important to follow the instructions from the doctor or nurse to complete the courses of injections.
Danish: Det er vigtigt at følge lægens eller sundhedspersonalets vejledning, så hele vaccinationsprogrammet bliver gennemført.
English: Vaccine effectiveness or efficacy (VE) was demonstrated in preventing culture-confirmed IPD due to vaccine pneumococcal serotypes when Synflorix was given to infants in either 2+1 or 3+1 schedules in FinIP or 3+1 schedule in COMPAS (see Table 1).
Danish: Der blev påvist vaccine-effektivitet eller vaccine-virkning (VE) til forebyggelse af kulturbekræftet IPD, forårsaget af pneumokokserotyperne i vaccinen, når Synflorix blev givet til spædbørn enten som 2+1- eller 3+1-vaccinationsprogram i FinIP eller som 3+1-vaccinationsprogram i COMPAS (se tabel
English: Synflorix should under no circumstances be administered intravascularly or intradermally.
Danish: Synflorix må under ingen omstændigheder gives intravaskulært eller intrakutant.
English: For most vaccine serotypes, group comparisons did not suggest any differences in post-primary immune responses between the HIV+/+ and HIV-/- groups, or the HIV+/- and HIV-/- groups, except for a trend towards a lower percentage of subjects reaching OPA titres ≥ 8 and lower OPA GMTs in the HIV+/+ group.
Danish: For de fleste af vaccines serotyper, viste gruppe sammenligninger ikke nogen forskel i immunresponset efter primær vaccination mellem hiv +/+ og hiv -/- grupperne, eller hiv +/- og hiv -/grupperne, bortset fra en tendens til, at et lavere antal personer opnåede OPA titer ≥ 8 og lavere OPA GMTs i gruppen for hiv +/+.
English: The assessment of potential efficacy against IPD pre-licensure was based on a comparison of immune responses to the seven serotypes shared between Synflorix and another pneumococcal conjugate vaccine for which protective efficacy was evaluated previously (i.e. 7-valent Prevenar), as recommended by the WHO.
Danish: Vurderingen af den potentielle virkning mod IPD blev inden udstedelse af markedsføringstilladelse baseret på sammenligning af immunresponset på de 7 serotyper, som findes i både Synflorix og en anden konjugeret pneumokokvaccine, som tidligere var blevet evalueret (f.eks. 7-valent Prevenar), som anbefalet af WHO.
English: In the same study, Synflorix was shown to elicit functional antibodies to all vaccine serotypes.
Danish: Det samme studie viste, at Synflorix fremkaldte funktionelle antistoffer mod alle vaccineserotyper.
English: In COMPAS it was 66.7% (95% CI: 21.8; 85.9; 7 versus 21 cases).
Danish: I COMPAS var det 66,7 % (95 % CI 21,8;85,9; 7 versus 21 tilfælde).
English: Children should receive the dose regimen of Synflorix that is appropriate to their age at the time of commencing the vaccination series (see section 4.2).
Danish: Børn skal følge det dosis-program med Synflorix, som passer til deres alder ved starten af vaccination (se pkt.
English: Immunogenicity and safety of Synflorix were assessed in a limited number of primed or unprimed subjects with congenital or acquired asplenia, splenic dysfunction or complement deficiencies: 6 subjects 2-5 years of age and 40 subjects 6-17 years of age (Synflorix is indicated up to 5 years of age).
Danish: Synflorix's immunogenicitet og sikkerhed er blevet vurderet hos et begrænset antal tidligere vaccinerede eller uvaccinerede personer med medført eller erhvervet aspleni, dysfunktion af milten eller komplementdefekter: 6 personer i alderen 2-5 år og 40 personer i alderen 6-17 år (Synflorix er indiceret op til en alder på 5 år).
English: Store in the original package in order to protect from light Should be used within 6 hours after first broaching of the vial
Danish: Opbevares i den originale yderpakning for at beskytte mod lys Skal anvendes inden for 6 timer efter anbrud
English: A clinical study evaluated the immunogenicity of Synflorix in 2-dose or 3-dose primed subjects in four European countries.
Danish: Et klinisk studie har vurderet Synflorix' immunogenicitet hos personer vaccineret med 2 eller 3 doser, i fire europæiske lande.
English: Children aged 12 months to 5 years will receive 2 injections.
Danish: Børn i alderen fra 12 måneder op til 5 år skal have 2 indsprøjtninger.
English: Immunosuppressive therapy and immunodeficiency
Danish: Immunsupprimerende behandling og immundefekt
English: For the cross-reactive serotype 19A, the results did not suggest any differences in ELISA antibody GMCs and OPA GMTs between groups.
Danish: For den krydsreaktive serotype 19A, viste resultaterne ikke nogen forskel i ELISA antistof GMCs og OPA GMTs imellem grupperne.
English: 1 adsorbed on aluminium phosphate
Danish: 1 mikrogram adsorberet på aluminiumphosphat
English: Therefore the degree and duration of protection against invasive pneumococcal disease and otitis media due to these three serotypes in children of this age group following a single dose of Synflorix cannot be predicted.
Danish: Derfor kan niveauet og varigheden af beskyttelsen efter en enkeltdosis Synflorix mod invasiv pneumokoksygdom og otitis media, der er forårsaget af disse tre serotyper, ikke forudsiges for børn i denne aldersgruppe.
English: Clinical data generated with paracetamol and ibuprofen suggest that the prophylactic use of paracetamol might reduce the fever rate, while prophylactic use of ibuprofen showed a limited effect in reducing fever rate.
Danish: Kliniske data fra studier med paracetamol og ibuprofen tyder på, at profylaktisk administration af paracetamol kan nedsætte feberudviklingen, mens profylaktisk administration af ibuprofen har en begrænset virkning til at nedsætte feberudviklingen.
English: Immunogenicity of Synflorix containing the preservative 2-phenoxyethanol (2-PE)
Danish: Immunogenicitet for Synflorix der indeholder konserveringsmidlet 2-phenoxyethanol (2-PE)
English: Infants aged 7 to 11 months will receive 2 injections.
Danish: Spædbørn i alderen 7-11 måneder skal have 2 indsprøjtninger.
English: Non-inferiority was demonstrated as the upper limit of the 2-sided 95% CI of the antibody GMC ratios was below 2 for each of the 10 vaccine serotypes and for serotype 19A.
Danish: Der blev påvist non-inferioritet, da den øvre grænse for det 2-sidet 95 % CI af antisof GMC ratioer var under 2, for hver af de 10 serotyper i vaccinen og for serotype 19A.
English: Immunogenicity following a fourth dose (booster dose) at 15 to 18 months of age was evaluated in 44 very preterm, 69 preterm and 127 full term infants.
Danish: Immunogeniciteten efter fjerde dosis (boosterdosis) ved 15-18-måneders alderen blev evalueret hos 44 meget præmature spædbørn, hos 69 præmature spædbørn og hos 127 spædbørn født omkring terminen.
English: Very common Drowsiness Rare
Danish: Meget almindelig Døsighed Sjælden
English: • loss of appetite
Danish: • appetitløshed.
English: Adjusted Effectiveness(2) % (95% CI)
Danish: Justeret effektivitet(2) % (95 % CI)
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 meget for tidligt fødte børn (født i uge 28 eller tidligere i svangerskabet) kan længere mellemrum mellem vejrtrækningerne forekomme i 2-3 dage efter vaccinationen.
English: These results are indicative of immunological memory in primed subjects for all vaccine serotypes and the cross-reactive serotype 19A.
Danish: Disse resultater indikerer immunologisk hukommelse hos vaccinerede børn over for alle vaccineserotyper samt over for den krydsreaktive serotype 19A.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Based on 1.5 years of surveillance following Synflorix introduction, with over 90% coverage in the vaccine-eligible age group, a decrease in vaccine serotype IPD incidence (largely due to changes in serotype 7F disease) was observed with no concomitant increase in non-vaccine serotype IPD incidence.
Danish: Baseret på 1,5 års overvågning efter introduktion af Synflorix og med over 90 % vaccination af den berettigede aldersgruppe blev der observeret et fald i hyppigheden af IPD forårsaget af vaccineserotyper (hovedsageligt på grund af ændringer i serotype 7F-sygdom) uden samtidig stigning i hyppigheden af IPD forårsaget af non-vaccineserotyper.
English: Infants from 6 weeks to 6 months of age:
Danish: Spædbørn i alderen fra 6 uger til 6 måneder:
English: A booster (third) dose is recommended in the second year of life with an interval of at least 2 months after the last primary dose.
Danish: Det anbefales at give en boosterdosis (tredje dosis) i det andet leveår med et interval på mindst 2 måneder efter sidste primære dosis.
English: In both schedules, a booster response indicative of immunological priming was observed.
Danish: For begge programmer indikerede boosterresponset immunologisk priming.
English: A clinical study conducted in India assessing a booster dose given at 9-12 or 15-18 months of age in 66 and 71 children, respectively, following primary vaccination at 6, 10 and 14 weeks of age, did not suggest differences between groups in terms of antibody GMCs.
Danish: Et klinisk studie udført i Indien, som vurderede boosterdosis givet ved 9-12 måneders alderen eller ved 15-18 måneders alderen, hos henholdsvis 66 og 71 børn, efter en primær vaccination ved 6, 10 og 14 ugers alderen, viste ikke forskel mellem grupperne i henhold til antistof GMCs.