natgillin/translations-raw huggingface dataset:
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. 
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.
Det anbefalede immuniseringsprogram til at sikre optimal beskyttelse består af fire doser, hver på 0,5 ml. 
The recommended immunisation series to ensure optimal protection consists of four doses, each of 0.5 ml.
I prospektive studier blev det estimeret, at 30-50 % af pneumonitilfældene skyldes Streptococcus pneumoniae. 
In prospective studies, Streptococcus pneumoniae was estimated to be responsible for 30-50% of pneumonia cases.
Tabel over bivirkninger Bivirkninger (i alle aldersgrupper) er kategoriseret ud fra hyppighed. 
Adverse reactions (for all age groups)have been categorised by frequency.
Overfølsomhed over for de aktive stoffer, over for et eller flere af hjælpestofferne anført i punkt 6.1 eller nogen af bærerproteinerne. 
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to any of the carrier proteins.
Disse kan genkendes ved: - hævet og kløende udslæt (nældefeber) - hævelser, sommetider i ansigtet eller munden (angioødem), som gør det vanskeligt at trække vejret - besvimelse. 
These can be recognised by: - raised and itchy rash (hives) - swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing - collapse
Kontakt lægen eller apotekspersonalet, før dit barn får vaccinen, hvis: • dit barn har blødningsproblemer eller let får blå mærker. 
Check with your doctor or pharmacist before this vaccine is given if: • your child has a bleeding problem or bruises easily.
Synflorix' sikkerhed og virkning hos børn over 5 år er ikke klarlagt. 
The safety and efficacy of Synflorix in children over 5 years of age have not been established.
GlaxoSmithKline Biologicals Kft. Homoki Nagy István utca 1. 
GlaxoSmithKine Biologicals Kft. Homoki Nagy István utca 1.
Samtidig anvendelse med profylaktisk administration af antipyretika 
Use with prophylactic administration of antipyretics
Synflorix gives altid som en indsprøjtning i en muskel. 
Synflorix is always injected into a muscle.
Alle bekræftede dyrkninger Alle vaccineserotyper(2) 
Any culture confirmed Any vaccine serotype(2)
Generelt sås sammenlignelige vaccineresponser ved de forskellige undersøgte programmer, dog blev et højere immunrespons fundet ved 2-4-6-måneders-programmet. 
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.
Dato for første markedsføringstilladelse: 30. marts 2009 Dato for seneste fornyelse: 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 March 2009
Hyppigheden er rapporteret som: Meget almindelig: 
Frequencies are reported as: Very common: (≥1/10) Common:
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 
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
Profylaktisk anvendelse af antipyretika 
Prophylactic use of antipyretics
VE Vaccine-effektivitet (FinIP) eller vaccine-virkning (COMPAS) N Antal personer i gruppen 
VE Vaccine effectiveness (FinIP) or efficacy (COMPAS) N number of subjects per group
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 %). 
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%).
I et klinisk studie fik børn enten Synflorix (N=603) eller 7-valent Prevenar (N=203) samtidigt med en DTPw -vaccine. 
In a clinical study children received either Synflorix (N=603) or 7-valent Prevenar (N=203) concomitantly with a DTPw containing vaccine.
Farmakoterapeutisk klassifikation: Vacciner, pneumokokvacciner, ATC-kode: J07AL52 Epidemiologiske data 
Pharmacotherapeutic group: vaccines, pneumococcal vaccines, ATC code: J07AL52
Synflorix må ikke blandes med andre vacciner. 
Synflorix should not be mixed with other vaccines.
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. 
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.
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). 
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).
(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). 
(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).
Der sås ingen stigning i hyppigheden eller sværhedsgraden af bivirkningerne ved de efterfølgende doser i det primære vaccinationsprogram. 
No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the primary vaccination series.
Hos børn over 12 måneder øges risikoen for smerter på administrationsstedet med stigende alder. 
For children > 12 months of age, the risk of pain at the injection site may increase with increasing age.
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. 
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.
Boostervaccination med Synflorix kan øge risikoen for bivirkninger. 
Booster doses of Synflorix may increase the risk of side effects.
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. 
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).
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. 
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.
(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. 
(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.
Effekten var 100 % (95 % CI 41,9; 100) mod bakteriel pneumokokpneumoni eller empyem forårsaget af serotyperne i vaccinen. 
Efficacy was 100% (95% CI: 41.9; 100) against bacteraemic pneumococcal pneumonia or empyema due to vaccine serotypes.
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. 
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.
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. 
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.
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). 
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).
De foretrukne administrationssteder er anterolateralt på låret hos spædbørn eller deltoideusmusklen i overarmen hos de lidt større børn. 
The preferred sites are anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in young children.
• krampeanfald uden feber eller pga. høj feber 
• fits without temperature or due to high temperature (fever)
Som for andre vacciner skal administration af Synflorix udsættes hos personer med svær, akut febril sygdom. 
As with other vaccines, the administration of Synflorix should be postponed in subjects suffering from acute severe febrile illness.
IPD Invasiv pneumokoksygdom 
IPD Invasive Pneumococcal Disease
Ikke vaccinerede spædbørn og børn i alderen ≥ 7 måneder: 
Unvaccinated infants and children ≥ 7 months of age:
Synflorix indeholder natrium 
Synflorix contains sodium
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. 
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.
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: 
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:
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. 
Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Synflorix should receive 23-valent pneumococcal polysaccharide vaccine.
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. 
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.
I alle studierne blev Synflorix administreret samtidig med de anbefalede børnevacciner. 
In all trials, Synflorix was administered concurrently with the recommended childhood vaccines.
Persistensen af immunresponset blev observeret i alderen 24-27 måneder for hver gruppe, dvs. op til 15 måneder efter booster vaccinationen. 
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.
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). 
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).
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. 
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.
4-dosis beholder 3 år 
4-dose container 3 years
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. 
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.
Tegn på en overfølsomhedsreaktion kan være kløende hududslæt, stakåndethed og hævelse af ansigt eller tunge. 
Signs of an allergic reaction may include itchy skin rash, being short of breath and swelling of the face or tongue.
Pakningsstørrelse på 1, 10 eller 50. 
Pack size of 1, 10 or 50.
Kramper (inklusive feberkramper) 
Convulsions (including febrile convulsions)
Hiv-positive spædbørn (hiv +/+) og hiv-negative spædbørn født af hiv-positive mødre (hiv +/-) 
HIV positive (HIV+/+) infants and HIV negative infants born from HIV positive mothers (HIV+/-)
Den første dosis kan gives så tidligt som i 6-ugers alderen. 
The first dose may be given as early as 6 weeks of age.
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. 
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.
Ikke vaccinerede spædbørn og børn i alderen ≥ 7 måneder 
Unvaccinated infants and children ≥ 7 months of age
Den første dosis kan gives så tidligt som i 6-ugers alderen, efterfulgt af en dosis der administreres 2 måneder senere. 
The first dose may be given as early as 6 weeks of age with a second dose administered 2 months later.
Børn, som har fået 7-valent Prevenar, har dog ikke fået den primære beskyttelse mod de ekstra serotyper i Synflorix (1, 5, 7F). 
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).
Resultaterne for protein D viste sammenlignelige immunrespons efter primærvaccination og boosterdosis mellem grupperne. 
The results for protein D suggested comparable post-primary and post-booster immune responses between groups.
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. 
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.
Efter boostervaccination var de hyppigste bivirkninger smerte på administrationsstedet og irritabilitet, som blev observeret hos hhv. ca. 51 % og 53 %. 
Following booster vaccination, the most common adverse reactions were pain at the injection site and irritability, which occurred at approximately 51% and 53% respectively.
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. 
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.
Efter anbrud af flerdosisbeholder: 
After first opening of multidose vial:
Unormal gråd 
• unusual crying
1-dosis og 2-dosis beholder 4 år 
1-dose and 2-dose containers 4 years
De forskellige injicerbare vacciner skal altid administreres på forskellige administrationssteder. 
Different injectable vaccines should always be given at different injection sites.
Det anbefales også at administrere et lægemiddel, der nedsætter feber hos børn med kramper eller som tidligere har haft feberkramper. 
It is also recommended to administer a medicine that lowers fever in children with convulsion disorders or with prior history of febrile convulsions.
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). 
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.
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. 
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.
Kontrol program 
Control schedule
Hvis Synflorix administreres samtidigt med andre vacciner, skal der anvendes forskellige administrationssteder. 
If Synflorix is co-administered with other vaccines, different injection sites should be used.
Det vides ikke, om det lidt lavere niveau af antistoffer har nogen indflydelse på, hvor godt dit barn er beskyttet mod pneumokok-sygdom. 
It is not known whether the reduction in antibody levels has an impact on the protection against pneumococcal disease.
I tilfælde af observation af et af de ovennævnte forhold skal vaccinen kasseres. 
In the event of either being observed, discard the vaccine.
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) 
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)
Læs indlægssedlen inden brug Intramuskulær anvendelse 
Read the package leaflet before use Intramuscular use
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. 
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.
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). 
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).
(booster), som skal gives mindst 6 måneder efter tredje indsprøjtning. 
which will be given at least 6 months after the third injection.
For begge programmer indikerede boosterresponset immunologisk priming for alle vaccineserotyper (tabel 7 og 8). 
In both schedules, a booster response indicative of immunological priming was observed for each vaccine serotype (Table 7 and Table 8).
Vaccinen skal gives som intramuskulær injektion. 
The vaccine should be given by intramuscular injection.
Immunogenicitetsdata hos præmature spædbørn 
Immunogenicity data in preterm infants
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. 
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).
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. 
• 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
Betydningen af disse observationer for beskyttelseseffekten er ikke kendt. 
The implications of these findings for protective efficacy are not known.
Det anbefales, at personer, der får den første dosis i et vaccinationsprogram med Synflorix, gennemfører hele vaccinationsprogrammet med Synflorix. 
It is recommended that subjects who receive a first dose of Synflorix complete the full vaccination course with Synflorix.
Alle IPD vaccineserotyper(3) - Invasiv pneumoni eller bakteriæmi - Meningitis 
Any vaccine serotype IPD(3) - Invasive pneumonia or bacteraemia - Meningitis
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. 
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.
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. 
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.