FrancophonIA/ELRC3.0 huggingface dataset:
English: Effectiveness against physician-diagnosed AOM reported by parents was studied in the nested study within the FinIP trial.
Danish: Effektiviteten mod lægediagnosticeret AOM, som blev rapporteret af forældre, er undersøgt i understudiet af det kliniske studie FinIP.
English: CI Confidence Interval (1) First episode (2) Follow up period for a maximum of 40 months from 2 weeks after third primary dose (3) Not statistically significant by pre-defined criteria (One sided p=0.032).
Danish: CI Konfidensinterval (1) Første episode (2) Opfølgningsperiode på maksimalt 40 måneder fra 2 uger efter tredje primærdosis (3) Ikke statistisk signifikant ved prædefinerede kriterier (ensidig p = 0,032).
English: Vaccine efficacy n
Danish: Vaccineeffekt n
English: • temporarily stopping breathing (apnoea) if your child is born prematurely (before or at 28 weeks of pregnancy)
Danish: • midlertidigt stop af vejrtrækningen (apnø), hvis dit barn er født meget for tidligt (født i uge 28
English: Efficacy against pneumonia was assessed in COMPAS.
Danish: Virkningen mod pneumoni blev undersøgt i COMPAS.
English: Average follow-up, from first vaccination, was 24 to 28 months for invasive disease and hospital-diagnosed pneumonia.
Danish: Den gennemsnitlige catch-up-periode fra første vaccination var 24 til 28 måneder for invasiv sygdom og hospitalsdiagnosticeret pneumoni.
English: No data are available on subcutaneous administration of Synflorix.
Danish: Der findes ingen tilgængelige data for subkutan administration af Synflorix.
English: The response to serotype 7F was in the same range as for the seven serotypes in common between the two vaccines.
Danish: Responset for serotype 7F var i samme størrelsesorden som for de syv serotyper, som er fælles for de to vacciner.
English: The results of the COMPAS study, which was performed in Latin America, should be interpreted with caution due to possible differences in epidemiology of pneumonia in different geographical locations.
Danish: Resultaterne af COMPAS-studiet, som blev udført i Latinamerika, skal tolkes med forsigtighed på grund af muligheden for forskellig epidemiologi af pneumoni i forskellige geografiske områder.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Danish: Som ved alle injicerbare vacciner, skal relevant medicinsk behandling og overvågning være umiddelbart tilgængelig i tilfælde af sjælden anafylaktisk reaktion, efter administration af vaccinen.
English: The immune responses elicited by Synflorix in previously unvaccinated older children were evaluated in three clinical studies.
Danish: Immunrespons fremkaldt af Synflorix hos ikke tidligere vaccinerede ældre børn er evalueret i tre kliniske studier.
English: Synflorix helps your body to make its own antibodies.
Danish: Synflorix hjælper kroppen med at danne sine egne antistoffer.
English: Clinical AOM
Danish: Klinisk AOM
English: • Do not use this medicine after the expiry date which is stated on the carton.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The interval between the pneumococcal conjugate vaccine (Synflorix) and the 23-valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
Danish: Intervallet mellem den konjugerede pneumokokvaccine (Synflorix) og den 23-valente pneumokokpolysaccharidvaccine bør ikke være under 8 uger.
English: Booster dose at 9-12 versus 15-18 months of age
Danish: Boosterdosis ved 9-12 måneders alderen versus 15-18 måneders alderen
English: Hypotonic-hyporesponsive episode
Danish: Hypotoniske, hyporesponsive episoder
English: However, if your child gets any of these symptoms you should contact a doctor urgently.
Danish: Hvis dit barn får nogle af disse symptomer, skal du straks kontakte lægen.
English: Synflorix is not intended for use in adults.
Danish: Synflorix er ikke beregnet til brug hos voksne.
English: Studies with an 11-valent vaccine formulation representative for Synflorix revealed no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity.
Danish: Studier med en 11-valent vaccineformulering repræsentativ for Synflorix viste ingen særlige risici for mennesker ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet efter enkelte og gentagne doser.
English: Safety was also assessed in 435 previously unvaccinated children from 2 to 5 years old of which 285 subjects received 2 doses of Synflorix.
Danish: Sikkerheden er også undersøgt hos 435 ikke tidligere vaccinerede børn i alderen 2-5 år, hvoraf 285 personer fik 2 doser Synflorix.
English: 7-valent Prevenar Difference in % ≥ 0.20µg/ml (7valent Prevenar minus Synflorix)
Danish: Forskel i % ≥ 0,20 µg/ml (7-valent Prevenar minus Synflorix)
English: Control(2)
Danish: Kontrol(2)
English: In a nested study, infants were followed up till approximately 21 months of age to assess impact on nasopharyngeal carriage and physician-diagnosed AOM reported by parents.
Danish: I et understudie blev spædbørn fulgt op til ca. 21-månedersalderen for at vurdere indvirkning på nasofaryngal bærertilstand og lægediagnosticeret AOM rapporteret af forældre.
English: Effectiveness following catch-up immunisation
Danish: Effektivitet efter catch-up-immunisering
English: Booster dose at 9-10 months of age
Danish: Boosterdosis ved 9-10 måneders alderen
English: Immune responses to the extra three serotypes in Synflorix were also measured.
Danish: Immunresponset på de tre ekstra serotyper i Synflorix blev også vurderet.
English: The 10 pneumococcal serotypes included in this vaccine represent the major disease-causing serotypes in Europe covering approximately 56% to 90% of invasive pneumococcal disease (IPD) in children <5 years of age.
Danish: De 10 pneumokokserotyper, som indgår i denne vaccine, repræsenterer hovedparten af de sygdomsfremkaldende serotyper som findes i Europa og dækker ca. 56-90 % af de invasive pneumokoksygdomme (IPD) hos børn under 5 år.
English: Prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions.
Danish: Profylaktisk administration af antipyretika før eller umiddelbart efter vaccinationen kan nedsætte forekomst og intensitet af febril reaktion som følge af vaccination.
English: Non-typeable Haemophilus influenzae (NTHi)
Danish: Ikke kapselbærende Haemophilus influenzae (NTHi)
English: Only HIV+/+ infants with WHO classification stage 1 (asymptomatic) or 2 (mild symptoms) were to be enrolled.
Danish: Det var kun hiv +/+ spædbørn med WHO klassifikation fase 1 (asymptomatisk) eller fase 2 (lette symptomer) der skulle inkluderes.
English: • Children aged 7-11 months received 2 primary doses followed by a booster dose in the second year of life.
Danish: • Børn i alderen 7-11 måneder modtog 2 primære doser efterfulgt af en boosterdosis i det andet leveår.
English: Instructions for administration of the vaccine 1.
Danish: Instruktion for administration af vaccinen:
English: In this age group, serotypes 1, 5 and 7F account for 3.3% to 24.1% of IPD depending on the country and time period studied.
Danish: I denne aldersgruppe er serotype 1, 5 og 7F årsag til 3,3-24,1 % af IPD afhængig af land og tidspunkt.
English: Pre-booster GMCs (8 to 12 months after the last primary dose) were generally similar for the two vaccines.
Danish: GMCs før boostervaccinationen (8-12 måneder efter sidste primærdosis) var generelt sammenlignelige for de to vacciner.
English: No increase in the incidence of AOM due to other bacterial pathogens or non-vaccine/non-vaccine related serotypes was observed in either COMPAS (based on the few cases reported) or POET trial.
Danish: Der blev ikke set nogen stigning i forekomsten af AOM, forårsaget af andre patogene bakterier eller ikke-vaccine/ikke-vaccinerelaterede serotyper, hverken i COMPAS (baseret på de få rapporterede tilfælde) eller i POET-studiet.
English: Immunogenicity in special population
Danish: Immunogenicitet hos særlige populationer
English: • Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR' er)
English: Effectiveness/efficacy in infant cohort below 7 months of age at enrolment
Danish: Effektivitet/virkning i kohorten af spædbørn i alderen under 7 måneder ved indskrivning
English: • allergic reactions such as skin allergies
Danish: • overfølsomhedsreaktioner, f.eks. allergiske hudreaktioner
English: CI Confidence Interval
Danish: CI konfidensinterval
English: As with all vaccines, Synflorix may not fully protect all children who are vaccinated.
Danish: Som for alle andre vacciner, beskytter Synflorix ikke nødvendigvis alle børn, som bliver vaccineret fuldt ud.
English: The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact on pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographical areas.
Danish: Synflorix skal anvendes i henhold til officielle retningslinjer under hensyntagen til virkningen på pneumokoksygdomme i forskellige aldersgrupper og variationen i epidemiologi i forskellige geografiske områder.
English: The recommended immunisation series to ensure optimal protection consists of four doses, each of 0.5 ml.
Danish: Det anbefalede immuniseringsprogram til at sikre optimal beskyttelse består af fire doser, hver på 0,5 ml.
English: In prospective studies, Streptococcus pneumoniae was estimated to be responsible for 30-50% of pneumonia cases.
Danish: I prospektive studier blev det estimeret, at 30-50 % af pneumonitilfældene skyldes Streptococcus pneumoniae.
English: Adverse reactions (for all age groups)have been categorised by frequency.
Danish: Tabel over bivirkninger Bivirkninger (i alle aldersgrupper) er kategoriseret ud fra hyppighed.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to any of the carrier proteins.
Danish: Overfølsomhed over for de aktive stoffer, over for et eller flere af hjælpestofferne anført i punkt 6.1 eller nogen af bærerproteinerne.
English: These can be recognised by: - raised and itchy rash (hives) - swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing - collapse
Danish: Disse kan genkendes ved: - hævet og kløende udslæt (nældefeber) - hævelser, sommetider i ansigtet eller munden (angioødem), som gør det vanskeligt at trække vejret - besvimelse.
English: Check with your doctor or pharmacist before this vaccine is given if: • your child has a bleeding problem or bruises easily.
Danish: Kontakt lægen eller apotekspersonalet, før dit barn får vaccinen, hvis: • dit barn har blødningsproblemer eller let får blå mærker.
English: The safety and efficacy of Synflorix in children over 5 years of age have not been established.
Danish: Synflorix' sikkerhed og virkning hos børn over 5 år er ikke klarlagt.
English: GlaxoSmithKine Biologicals Kft. Homoki Nagy István utca 1.
Danish: GlaxoSmithKline Biologicals Kft. Homoki Nagy István utca 1.
English: Use with prophylactic administration of antipyretics
Danish: Samtidig anvendelse med profylaktisk administration af antipyretika
English: Synflorix is always injected into a muscle.
Danish: Synflorix gives altid som en indsprøjtning i en muskel.
English: Any culture confirmed Any vaccine serotype(2)
Danish: Alle bekræftede dyrkninger Alle vaccineserotyper(2)
English: In general, comparable vaccine responses were observed for the different schedules, although somewhat higher immune responses were noted for the 2-4-6 month schedule.
Danish: Generelt sås sammenlignelige vaccineresponser ved de forskellige undersøgte programmer, dog blev et højere immunrespons fundet ved 2-4-6-måneders-programmet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 March 2009
Danish: Dato for første markedsføringstilladelse: 30. marts 2009 Dato for seneste fornyelse:
English: Frequencies are reported as: Very common: (≥1/10) Common:
Danish: Hyppigheden er rapporteret som: Meget almindelig:
English: N number of subjects per group n/% number/percentage of subjects reporting a first episode of B-CAP anytime from 2 weeks after the administration of the 3rd dose
Danish: N antal personer per gruppe n/% antal/procentdel af personer, der rapporterede første tilfælde af B-CAP fra 2 uger efter administration af 3. dosis
English: Prophylactic use of antipyretics
Danish: Profylaktisk anvendelse af antipyretika
English: VE Vaccine effectiveness (FinIP) or efficacy (COMPAS) N number of subjects per group
Danish: VE Vaccine-effektivitet (FinIP) eller vaccine-virkning (COMPAS) N Antal personer i gruppen
English: Clinical studies demonstrated that the immune responses and the safety profiles of the co-administered vaccines were unaffected, with the exception of the inactivated poliovirus type 2 response, for which inconsistent results were observed across studies (seroprotection ranging from 78% to 100%).
Danish: Kliniske studier har vist, at immunrespons og sikkerhedsprofil for vacciner, der er administreret på samme tid, var uændret med undtagelse af responset for inaktiveret poliovirus type 2, hvor der blev set inkonsistente resultater på tværs af studierne (serobeskyttelse fra 78 % til 100 %).
English: In a clinical study children received either Synflorix (N=603) or 7-valent Prevenar (N=203) concomitantly with a DTPw containing vaccine.
Danish: I et klinisk studie fik børn enten Synflorix (N=603) eller 7-valent Prevenar (N=203) samtidigt med en DTPw -vaccine.
English: Pharmacotherapeutic group: vaccines, pneumococcal vaccines, ATC code: J07AL52
Danish: Farmakoterapeutisk klassifikation: Vacciner, pneumokokvacciner, ATC-kode: J07AL52 Epidemiologiske data
English: Synflorix should not be mixed with other vaccines.
Danish: Synflorix må ikke blandes med andre vacciner.
English: Likely bacterial CAP (B-CAP) is defined as radiologically confirmed CAP cases with either alveolar consolidation/pleural effusion on the chest X-ray, or with non-alveolar infiltrates but with C reactive protein (CRP) ≥ 40 mg/l.
Danish: En sandsynlig bakteriel CAP (B-CAP) er defineret som et radiologisk verificeret CAP-tilfælde med enten alveolær konsolidering/pleuraeffusion på røntgenbillede af brystet eller uden alveolær infiltration men med C-reaktivt protein (CRP) ≥ 40 mg/l.
English: In COMPAS, 7,214 subjects [Total Vaccinated cohort (TVC)] were included in the AOM efficacy analysis of which 5,989 subjects were in the ATP cohort (Table 3).
Danish: I COMPAS blev 7.214 personer (TV- (total vaccineret) kohorte) inkluderet i AOM-effekt-analysen, hvoraf 5.989 personer var i ATP-kohorten (tabel 3).
English: (1) The relative rate reduction indicates how much the incidence of IPD in children of ≤5 years of age was reduced in the Synflorix cohort (followed for 3 years after NIP introduction) versus age and season matched non-vaccinated historical cohorts (each followed for 3 year periods before introduction of Synflorix into NIP).
Danish: (1) Den relative reduktion af hyppigheden viser, hvor meget forekomsten af IPD hos børn ≤ 5 år blev reduceret i Synflorix-kohorten (fulgt i 3 år efter introduktion af NIP) versus alders- og sæsonmatchede historiske ikke-vaccinerede kohorter (hver fulgt i 3-års perioder før introduktion af Synflorix i NIP).
English: No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the primary vaccination series.
Danish: Der sås ingen stigning i hyppigheden eller sværhedsgraden af bivirkningerne ved de efterfølgende doser i det primære vaccinationsprogram.
English: For children > 12 months of age, the risk of pain at the injection site may increase with increasing age.
Danish: Hos børn over 12 måneder øges risikoen for smerter på administrationsstedet med stigende alder.
English: Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, prenatal exposure to anti-retroviral therapy and/or to HIV, or other causes, may have reduced antibody response to vaccination.
Danish: Børn med svækket immunforsvar, hvad enten det skyldes immunsupprimerende behandling, en genetisk defekt, hiv-infektion, prænatal eksponering til antiretroviral behandling og/eller hiv, eller andre årsager, kan have nedsat antistofrespons på vaccination.
English: Booster doses of Synflorix may increase the risk of side effects.
Danish: Boostervaccination med Synflorix kan øge risikoen for bivirkninger.
English: It is not known whether this lower functional immune response against serotypes 1 and 5 will result in lower protective efficacy against invasive disease, pneumonia or otitis media caused by these serotypes (see section 5.1).
Danish: Det vides ikke om det lavere funktionelle immunrespons for serotype 1 og 5 vil medføre en lavere beskyttelse mod invasiv sygdom, pneumoni eller otitis media forårsaget af disse serotyper (se pkt.
English: The HIV exposure or infection did not appear to alter the effect of Synflorix on pneumococcal carriage up to 24-27 months of age, i.e. up to 15 months following booster vaccination.
Danish: Eksponering for hiv eller hiv-infektion syntes ikke at ændre på Synflorix' virkning overfor bærertilstand af pneumokok op til en alder på 24-27 måneder, dvs. op til 15 måneder efter booster vaccinationen.
English: (1) Culture or PCR confirmed IPD (2) The adjusted effectiveness represents the percent reduction in IPD in the Synflorix vaccinated group compared to the unvaccinated group, controlling for confounding factors.
Danish: (1) IPD bekræftet ved dyrkning eller PCR (2) Den justerede effektivitet repræsenterer den procentvise reduktion i IPD hos gruppen, der blev vaccineret med Synflorix, sammenlignet med gruppen, der ikke blev vaccineret, under kontrol af konfunderende faktorer.
English: Efficacy was 100% (95% CI: 41.9; 100) against bacteraemic pneumococcal pneumonia or empyema due to vaccine serotypes.
Danish: Effekten var 100 % (95 % CI 41,9; 100) mod bakteriel pneumokokpneumoni eller empyem forårsaget af serotyperne i vaccinen.
English: In comparative clinical studies, the incidence of local and general adverse events reported within 4 days after each vaccination dose was within the same range as after vaccination with 7-valent Prevenar.
Danish: I et sammenlignende klinisk studie, var den rapporterede hyppighed af lokale og generelle bivirkninger 4 dage efter hver vaccine-dosis i samme størrelsesorden som efter vaccination med 7valent Prevenar.
English: Safety assessment of Synflorix was based on clinical trials involving the administration of 63,905 doses of Synflorix to 22,429 healthy children and 137 preterm infants as primary vaccination.
Danish: Sikkerhedsvurderingen af Synflorix er baseret på kliniske studier, som omfatter administration af 63.905 doser Synflorix til 22.429 raske børn og 137 præmature spædbørn som primærvaccination.
English: The effect of Synflorix on nasopharyngeal carriage was studied in 2 double-blind randomised studies using an inactive control: in the nested study of FinIP in Finland (5,023 subjects) and in COMPAS (1,700 subjects).
Danish: Synflorix' indvirkning på nasofaryngal bærertilstand blev undersøgt i 2 dobbelt-blindede, randomiserede studier med en inaktiv kontrol: i understudiet af FinIP i Finland (5.023 personer) og i COMPAS (1.700 personer).
English: The preferred sites are anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in young children.
Danish: De foretrukne administrationssteder er anterolateralt på låret hos spædbørn eller deltoideusmusklen i overarmen hos de lidt større børn.
English: • fits without temperature or due to high temperature (fever)
Danish: • krampeanfald uden feber eller pga. høj feber
English: As with other vaccines, the administration of Synflorix should be postponed in subjects suffering from acute severe febrile illness.
Danish: Som for andre vacciner skal administration af Synflorix udsættes hos personer med svær, akut febril sygdom.
English: IPD Invasive Pneumococcal Disease
Danish: IPD Invasiv pneumokoksygdom
English: Unvaccinated infants and children ≥ 7 months of age:
Danish: Ikke vaccinerede spædbørn og børn i alderen ≥ 7 måneder:
English: Synflorix contains sodium
Danish: Synflorix indeholder natrium
English: In a clinical study, it has been demonstrated that Synflorix can be safely administered as a booster dose in the second year of life to children who had received 3 primary doses of 7-valent Prevenar.
Danish: I et klinisk studie er det påvist, at Synflorix kan administreres sikkert som boosterdosis i det andet leveår til børn, som har fået 3 primære doser 7-valent Prevenar.
English: The first clinical study evaluated the immune responses for vaccine serotypes and the cross-reactive serotype 19A in children aged 7-11 months, 12-23 months and 2 to 5 years:
Danish: I det første kliniske studie blev immunresponset for vaccineserotyper og den krydsreaktive serotype 19A hos børn i alderen 7-11 måneder, 12-23 måneder og 2-5 år evalueret:
English: Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Synflorix should receive 23-valent pneumococcal polysaccharide vaccine.
Danish: Hvis det er officielt anbefalet, skal børn i alderen ≥ 24 måneder, som er i risikogruppe og allerede primet med Synflorix, have en 23-valent pneumokokpolysaccharidvaccine.
English: Your doctor may ask you to give your child a medicine that lowers fever (such as paracetamol) before or immediately after Synflorix is given, especially in children being vaccinated with Synflorix and vaccines containing whole cell pertussis at the same time.
Danish: Lægen kan give dig besked på, at du skal give dit barn febernedsættende medicin (f.eks. paracetamol) før eller umiddelbart efter, at barnet har fået Synflorix, især hos børn, der vaccineres med Synflorix og vacciner, der indeholder helcelle pertussis på samme tid.
English: In all trials, Synflorix was administered concurrently with the recommended childhood vaccines.
Danish: I alle studierne blev Synflorix administreret samtidig med de anbefalede børnevacciner.
English: In each group, persistence of the immune responses was observed at 24-27 months of age, i.e. up to 15 months following booster vaccination.
Danish: Persistensen af immunresponset blev observeret i alderen 24-27 måneder for hver gruppe, dvs. op til 15 måneder efter booster vaccinationen.
English: Overall, the incidence of IPD was 35/100,000 person-years in those cohorts exposed to Synflorix, and 64/100,000 person-years in those exposed to 7-valent Prevenar, representing a statistically significant difference (p = 0.03).
Danish: Den overordnede forekomst af IPD var 35/100.000 personår i de kohorter, som fik Synflorix, og 64/100.000 personår i de kohorter, som fik 7valent Prevenar, hvilket viser en statistisk signifikant forskel (p = 0,03).
English: As for other vaccines administered intramuscularly, Synflorix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Danish: Som ved andre vacciner, der administreres intramuskulært, skal Synflorix gives med forsigtighed til personer med trombocytopeni eller andre koagulationsforstyrrelser, da der kan forekomme blødning efter en intramuskulær administration hos disse personer.
English: 4-dose container 3 years
Danish: 4-dosis beholder 3 år
English: It has also been demonstrated that Synflorix induces an immune response to the cross-reactive serotype 19A with 48.8% (95% CI: 42.9; 54.7) of vaccinees reaching an OPA titre ≥ 8 one month after a booster dose.
Danish: Det er også vist, at Synflorix inducerer et immunrespons mod den krydsreaktive serotype 19A, idet 48,8 % (95 % CI: 42,9;54,7) af de vaccinerede opnåede en OPA-titer ≥ 8 en måned efter en boosterdosis.
English: Signs of an allergic reaction may include itchy skin rash, being short of breath and swelling of the face or tongue.
Danish: Tegn på en overfølsomhedsreaktion kan være kløende hududslæt, stakåndethed og hævelse af ansigt eller tunge.