natgillin/translations-raw huggingface dataset:
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
• dit barn har en alvorlig infektion med høj feber (over 38 °C).
• your child has a severe infection with a high temperature (over 38 °C).
Antistofferne er en del af kroppens immunforsvar, som beskytter dit barn mod disse sygdomme.
The antibodies form a part of the immune system that will protect your child against these diseases.
Desuden har 19.466 børn og 116 præmature spædbørn fået en boosterdosis Synflorix i andet leveår.
Furthermore, 19,466 children and 116 preterm infants received a booster dose of Synflorix in the second year of life.
Hvis du har yderligere spørgsmål om brugen af denne vaccine, spørg din læge, apotekspersonalet eller sygeplejersken.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
Mindst 6 måneder efter den sidste indsprøjtning skal dit barn have yderligere en indsprøjtning (booster).
At least six months after the last injection, your child will receive an additional injection (booster).
Desuden var OPA GMTs i samme intervaller for begge grupper.
In addition, OPA GMTs were in same ranges for both groups.
Som for andre vacciner kan det forventes, at patienter i immunsuppressiv behandling ikke med sikkerhed kan opnå tilstrækkeligt respons.
As with other vaccines, it may be expected that in patients receiving immunosuppressive treatment an adequate response may not be elicited.
Effektivitet i overvågning efter markedsføring
Effectiveness in post-marketing surveillance
Der foreligger ingen humane data vedrørende brug under graviditet eller amning, og der foreligger ingen dyrestudier vedrørende reproduktion.
Human data on the use during pregnancy or breast-feeding and animal reproduction studies are not available.
Ud af disse modtog henholdsvis 76, 96 og 49 spædbørn en booster dosis.
Of these, 76, 96 and 49 infants, respectively, received a booster dose.
Effektresultater af vaccinen hos børn > 36 måneder indikerer aftagende beskyttelse.
Vaccine efficacy results in children > 36 months of age suggest a waning of protection.
(4) Individuelle serotyper, for hvilke statistisk signifikans blev nået i effektivitetsanalysen, som kontrollerede for konfunderende faktorer (der blev ikke justeret for multiplicitet).
(4) Individual serotypes for which statistical significance was reached in the effectiveness analysis controlling for confounding factors (no adjustment for multiplicity performed).
Andelen af personer i ATP-kohorten, som fik en boosterdosis, var 92,3 % i begge analyser.
The proportion of subjects who received the booster dose in the ATP cohort was 92.3% in both analyses.
For andre vaccineserotyper var antallet af rapporterede AOM-tilfælde for begrænset til at der kunne drages en konklusion om effektivitet.
For other vaccine serotypes, the number of AOM cases was too limited to allow any efficacy conclusion to be drawn.
Streptococcus pneumoniae og ikke-kapselbærende Haemophilus influenzae (NTHi) er de mest almindelige årsager til bakteriel AOM på verdensplan.
Streptococcus pneumoniae and Non-Typeable Haemophilus influenzae (NTHi) are the most common causes of bacterial AOM worldwide.
De officielle retningslinjer for immunisering mod difteri, tetanus og Haemophilus influenzae type b bør også følges.
Official recommendations for the immunisation against diphtheria, tetanus and Haemophilus influenzae type b should also be followed.
Inden for hver frekvensgruppe fremlægges bivirkningerne i rækkefølge af faldende alvorlighed.
Within each frequency grouping the adverse reactions are presented in the order of decreasing seriousness.
Efter NIP
After NIP
• Lægen har ordineret denne vaccine til dit barn personligt.
• This vaccine has been prescribed for your child only.
Vaccinens effekt mod B-CAP observeret i interimanalysen er anført nedenfor (tabel 2).
The vaccine efficacy against B-CAP observed at the interim analysis is presented below (table 2).
Før NIP
Before NIP
IPD, som skyldes individuelle serotyper(4) - 6B
IPD due to individual serotypes(4) - 6B
I begge studier var der et signifikant fald af de individuelle serotyper 6B og 19F.
In both studies there were significant decrease of individual serotypes 6B and 19F.
Tabel 3: Vaccine-effekt mod AOM(1) i COMPAS
Table 3: Vaccine efficacy against AOM(1) in COMPAS
Synflorix beskytter kun mod infektioner som skyldes de bakterier, som vaccinen er udviklet til.
Synflorix will only protect against infections caused by the bacteria for which the vaccine has been developed.
Tabel 5: Hyppighed af IPD og den tilsvarende reduktion i forekomsten i Finland IPD
Table 5: Rates of IPD and the corresponding rate reductions in Finland IPD
Immuniseringsprogrammet for Synflorix skal baseres på officielle retningslinjer.
The immunisation schedules for Synflorix should be based on official recommendations.
Allergiske reaktioner (f.eks. eksem, allergisk dermatitis, atopisk dermatitis)
Allergic reactions (such as eczema, allergic dermatitis, atopic dermatitis)
Akut otitis media (AOM) er en almindelig børnesygdom, med forskellig ætiologi.
Acute otitis media (AOM) is a common childhood disease with different aetiologies.
• dit barn er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer i vaccinen (angivet i punkt 6).
• your child is allergic to the active substance, or any of the other ingredients of this vaccine (listed in section 6).
Synflorix giver ikke beskyttelse mod andre mikroorganismer.
Synflorix does not provide protection against other microorganisms.
Sikkerhedsog immungenicitetsdata for Synflorix er ikke tilgængelig for personer i andre specifikke immunkompromitterede grupper og vaccination skal overvejes på individuel basis (se pkt.
Safety and immunogenicity data for Synflorix are not available for individuals in other specific immunocompromised groups and vaccination should be considered on an individual basis (see section
Pneumoni med forskellig ætiologi er globalt set en af de væsentligste årsager til morbiditet og mortalitet i barndommen.
Pneumonia of different aetiologies is a leading cause of childhood morbidity and mortality globally.
• Synflorix er en uklar, hvid suspension.
• Synflorix is a turbid white suspension.
Vaccinen er en uklar, hvid suspension.
The vaccine is a turbid white suspension.
Tal med lægen omkring antal og tidsintervaller for de insprøjtninger dit barn skal have.
Please speak to your doctor for information on the number and timing of injections for your child.
Tabel 4: Sammendrag af Synflorix' effektivitet mod IPD i Brasilien Typer af IPD(1)
Table 4: Summary of effectiveness of Synflorix for IPD in Brazil Types of IPD(1)
Effektiviteten mod lægediagnosticeret AOM, som blev rapporteret af forældre, er undersøgt i understudiet af det kliniske studie FinIP.
Effectiveness against physician-diagnosed AOM reported by parents was studied in the nested study within the FinIP trial.
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).
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).
Vaccineeffekt n
Vaccine efficacy n
• midlertidigt stop af vejrtrækningen (apnø), hvis dit barn er født meget for tidligt (født i uge 28
• temporarily stopping breathing (apnoea) if your child is born prematurely (before or at 28 weeks of pregnancy)
Virkningen mod pneumoni blev undersøgt i COMPAS.
Efficacy against pneumonia was assessed in COMPAS.
Den gennemsnitlige catch-up-periode fra første vaccination var 24 til 28 måneder for invasiv sygdom og hospitalsdiagnosticeret pneumoni.
Average follow-up, from first vaccination, was 24 to 28 months for invasive disease and hospital-diagnosed pneumonia.
Der findes ingen tilgængelige data for subkutan administration af Synflorix.
No data are available on subcutaneous administration of Synflorix.
Responset for serotype 7F var i samme størrelsesorden som for de syv serotyper, som er fælles for de to vacciner.
The response to serotype 7F was in the same range as for the seven serotypes in common between the two vaccines.
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.
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.
Som ved alle injicerbare vacciner, skal relevant medicinsk behandling og overvågning være umiddelbart tilgængelig i tilfælde af sjælden anafylaktisk reaktion, efter administration af vaccinen.
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.
Immunrespons fremkaldt af Synflorix hos ikke tidligere vaccinerede ældre børn er evalueret i tre kliniske studier.
The immune responses elicited by Synflorix in previously unvaccinated older children were evaluated in three clinical studies.
Synflorix hjælper kroppen med at danne sine egne antistoffer.
Synflorix helps your body to make its own antibodies.
Klinisk AOM
Clinical AOM
• Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
• Do not use this medicine after the expiry date which is stated on the carton.
Intervallet mellem den konjugerede pneumokokvaccine (Synflorix) og den 23-valente pneumokokpolysaccharidvaccine bør ikke være under 8 uger.
The interval between the pneumococcal conjugate vaccine (Synflorix) and the 23-valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
Boosterdosis ved 9-12 måneders alderen versus 15-18 måneders alderen
Booster dose at 9-12 versus 15-18 months of age
Hypotoniske, hyporesponsive episoder
Hypotonic-hyporesponsive episode
Hvis dit barn får nogle af disse symptomer, skal du straks kontakte lægen.
However, if your child gets any of these symptoms you should contact a doctor urgently.
Synflorix er ikke beregnet til brug hos voksne.
Synflorix is not intended for use in adults.
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.
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.
Sikkerheden er også undersøgt hos 435 ikke tidligere vaccinerede børn i alderen 2-5 år, hvoraf 285 personer fik 2 doser Synflorix.
Safety was also assessed in 435 previously unvaccinated children from 2 to 5 years old of which 285 subjects received 2 doses of Synflorix.
Forskel i % ≥ 0,20 µg/ml (7-valent Prevenar minus Synflorix)
7-valent Prevenar Difference in % ≥ 0.20µg/ml (7valent Prevenar minus Synflorix)
Kontrol(2)
Control(2)
I et understudie blev spædbørn fulgt op til ca. 21-månedersalderen for at vurdere indvirkning på nasofaryngal bærertilstand og lægediagnosticeret AOM rapporteret af forældre.
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.
Effektivitet efter catch-up-immunisering
Effectiveness following catch-up immunisation
Boosterdosis ved 9-10 måneders alderen
Booster dose at 9-10 months of age
Immunresponset på de tre ekstra serotyper i Synflorix blev også vurderet.
Immune responses to the extra three serotypes in Synflorix were also measured.
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.
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.
Profylaktisk administration af antipyretika før eller umiddelbart efter vaccinationen kan nedsætte forekomst og intensitet af febril reaktion som følge af vaccination.
Prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions.
Ikke kapselbærende Haemophilus influenzae (NTHi)
Non-typeable Haemophilus influenzae (NTHi)
Det var kun hiv +/+ spædbørn med WHO klassifikation fase 1 (asymptomatisk) eller fase 2 (lette symptomer) der skulle inkluderes.
Only HIV+/+ infants with WHO classification stage 1 (asymptomatic) or 2 (mild symptoms) were to be enrolled.
• Børn i alderen 7-11 måneder modtog 2 primære doser efterfulgt af en boosterdosis i det andet leveår.
• Children aged 7-11 months received 2 primary doses followed by a booster dose in the second year of life.
Instruktion for administration af vaccinen:
Instructions for administration of the vaccine 1.
I denne aldersgruppe er serotype 1, 5 og 7F årsag til 3,3-24,1 % af IPD afhængig af land og tidspunkt.
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.
GMCs før boostervaccinationen (8-12 måneder efter sidste primærdosis) var generelt sammenlignelige for de to vacciner.
Pre-booster GMCs (8 to 12 months after the last primary dose) were generally similar for the two vaccines.
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.
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.
Immunogenicitet hos særlige populationer
Immunogenicity in special population
• Periodiske, opdaterede sikkerhedsindberetninger (PSUR' er)
• Periodic Safety Update Reports
Effektivitet/virkning i kohorten af spædbørn i alderen under 7 måneder ved indskrivning
Effectiveness/efficacy in infant cohort below 7 months of age at enrolment
• overfølsomhedsreaktioner, f.eks. allergiske hudreaktioner
• allergic reactions such as skin allergies
CI konfidensinterval
CI Confidence Interval
Som for alle andre vacciner, beskytter Synflorix ikke nødvendigvis alle børn, som bliver vaccineret fuldt ud.
As with all vaccines, Synflorix may not fully protect all children who are vaccinated.
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.