FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
Danish: Anvendelsen af Prevenar 13 bør baseres på officielle anbefalinger under hensyntagen til risikoen for invasiv sygdom og pneumoni hos forskellige aldersgrupper, underliggende komorbiditet samt variabiliteten af serotype-epidemiologi i forskellige geografiske områder.
English: Table 4: Summary of effectiveness of 7-valent Prevenar for invasive pneumococcal disease Country (year of introduction)
Danish: Sammenfatning af effektiviteten af 7-valent Prevenar mod invasiv pneumokoksygdom Land (Markedsføringsår)
English: Vaccine serotypes: Two doses under age 1: 85%
Danish: Vaccineserotyper: To doser før 1-års alderen: 85 %
English: Typically, your child should receive an initial course of three injections of the vaccine followed by a booster dose.
Danish: Deres barn vil typisk få en indledende serie på tre indsprøjtninger af vaccinen efterfulgt af yderligere en dosis.
English: Between 11 and 15 months of age, your child will receive a fourth injection (booster).
Danish: Når barnet er mellem 11 og 15 måneder, skal det have en fjerde injektion (booster).
English: Prevenar 13 50-59 Relative to 60-64 Years
Danish: Prevenar 13 50-59 år i forhold til 60-64 år
English: Pack of 1, 10 and 50 pre-filled syringe, with or without needle - WITH BLUE BOX
Danish: Pakning med 1, 10 eller 50 fyldte injektionssprøjter, med eller uden kanyle - MED BLUE BOX
English: All episodes analysis
Danish: Analyse af alle episoder
English: Infants and children who have begun immunisation with Prevenar may switch to Prevenar 13 at any point in the schedule.
Danish: Spædbørn og børn, som er påbegyndt immunisering med Prevenar, kan skifte til Prevenar 13 på et hvilket som helst tidspunkt i planen.
English: The clinical relevance of these differences is not known.
Danish: Den kliniske relevans af disse forskelle kendes ikke.
English: Prevenar 13 immunogenicity clinical studies in infants, children and adolescents
Danish: Kliniske immunogenicitetsstudier med Prevenar 13 hos spædbørn, børn og teenagere
English: For all pivotal clinical trials, a serotype-specific opsonophagocytosis assay (OPA) was used as a surrogate to assess potential efficacy against invasive pneumococcal disease and pneumonia.
Danish: I alle pivotale kliniske forsøg blev der anvendt en serotypespecifik opsonofagocytoseanalyse (OPA) som surrogat til at vurdere en mulig effekt mod invasiv pneumokoksygdom og pneumoni.
English: Vaccine efficacy (95% CI) (1-sided p-value)
Danish: Vaccineeffekt (95 % CI) (1-sidet p-værdi)
English: For 9 serotypes, immune responses were related to age, with adults in the 50-59 years group showing statistically significantly greater responses than adults aged 60-64 years.
Danish: For 9 serotyper var immunresponset relateret til alderen, hvor voksne i aldersgruppen 50-59 år viste statistisk signifikant større respons end voksne i aldersgruppen 60-64 år.
English: Clinical studies have been conducted in a number of European countries and the US using a range of vaccination schedules, including two randomised non-inferiority studies (Germany using a 2, 3, 4 month primary series [006] and US using a 2, 4, 6 month primary series [004]).
Danish: Der er udført kliniske studier i flere europæiske lande og i USA med anvendelse af en række vaccinationsplaner, herunder to randomiserede non-inferioritetsstudier (i Tyskland en 2, 3 og 4 måneders primærserie (studie 006) og i USA en 2, 4 og 6 måneders primær serie (studie 004).
English: Episodes
Danish: Episoder
English: Study of Prevenar 13 containing the preservative 2-phenoxyethanol (2-PE):
Danish: Undersøgelse af Prevenar 13 med konserveringsmidlet 2-phenoxyethanol (2-PE):
English: Recurrent AOM (3 episodes in 6 months, or 4 episodes in 1 year) Recurrent AOM (5 episodes in 6 months, or 6 episodes in 1 year) Tympanostomy tube placement
Danish: Tilbagevendende AOM (3 episoder i løbet af 6 måneder, eller 4 episoder i løbet af et år)
English: Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunisation.
Danish: Personer med nedsat immunrespons, hvad enten det skyldes immunsuppressiv behandling, en genetisk defekt, infektion med humant immundefekt-virus (hiv) eller andre årsager, kan have nedsat antistofrespons på aktiv immunisering.
English: Therefore the use of Prevenar 13 should be avoided during pregnancy.
Danish: Prevenar 13 bør ikke anvendes under graviditet.
English: Convulsions (including febrile convulsions)
Danish: Krampeanfald (herunder feberkramper).
English: Your doctor may ask you to give your child paracetamol or other medicines that lower fever before Prevenar 13 is given.
Danish: Deres læge vil måske bede Dem om at give Deres barn paracetamol eller anden febernedsættende medicin inden vaccination med Prevenar 13.
English: If your child should become unresponsive or experience seizures (fits) after the vaccination, please contact your doctor immediately.
Danish: Hvis Deres barn ikke er kontaktbart eller får et krampeanfald efter vaccinationen, skal De straks kontakte en læge.
English: 84,496 subjects, 65 years and older received a single vaccination of either Prevenar 13 or placebo in a 1:1 randomisation.
Danish: 84.496 forsøgspersoner i alderen 65 år og derover fik en enkelt vaccination med enten Prevenar 13 eller placebo efter randomisering 1:1.
English: It is unknown whether immunological memory to all serotypes is induced in pre-term infants.
Danish: Det vides ikke, om præmature børn udvikler immunologisk hukommelse overfor alle serotyperne.
English: Infants aged 7-11 months
Danish: Spædbørn i alderen 7-11 måneder
English: Subcutaneous administration of Prevenar 13 was evaluated in a non-comparative study in 185 healthy Japanese infants and children who received 4 doses at 2, 4, 6 and 12-15 months of age.
Danish: Subkutan administration af Prevenar 13 blev vurderet i et ikke-komperativt studie med 185 raske japanske spædbørn og børn, som fik 4 doser, da de var 2, 4, 6 og 12-15 måneder gamle.
English: OPA GMT levels at baseline
Danish: OPA-GMT-niveauer ved baseline
English: NCKP: Clinical pneumonia with abnormal chest X-ray
Danish: NCKP: Klinisk pneumoni med abnorm thorax røntgen
English: • The first injection may be given from the age of six weeks.
Danish: • Den første indsprøjtning kan gives fra 6-ugers-alderen.
English: As otitis media is caused by many organisms other than pneumococcal serotypes represented in the vaccine, protection against all otitis media is expected to be low (see section 5.1).
Danish: Da otitis media forårsages af mange andre organismer end de pneumokok-serotyper, der findes i vaccinen, forventes beskyttelsen mod alle former for otitis media at være lille (se pkt.
English: In adults, an antibody threshold of serotype-specific pneumococcal polysaccharide IgG binding antibody concentration associated with protection has not been defined.
Danish: Hos voksne er der ikke defineret en antistofgrænseværdi for polysaccharid pneumokok serotypespecifik IgG-bindende antistofkoncentration forbundet med beskyttelse.
English: Immune responses as measured by IgG GMCs were assessed in 168-211 evaluable subjects approximately 1 month after vaccination.
Danish: Immunresponset målt efter IgG-GMC blev vurderet hos 168-211 evaluerbare forsøgspersoner ca. 1 måned efter vaccinationen.
English: • Fever of more than 39°C; tenderness at the vaccination-site interfering with movement, redness,
Danish: • Feber på mere end 39 °C, ømhed på vaccinationsstedet, som påvirker bevægelse, rødme,
English: As with concomitant administration with trivalent vaccines, immune responses to some pneumococcal serotypes were lower when both vaccines were given concomitantly.
Danish: Som det er tilfældet ved samtidig administration af trivalente vacciner, var immunresponset på visse pneumokokserotyper lavere, når de 2 vacciner blev givet samtidig.
English: Using the screening method, serotype-specific effectiveness estimates for 2 doses under the age of 1 year in the UK were 66 % (-29, 91 %) and 100 % (25, 100 %) for serotype 6B and 23F, respectively.
Danish: Når screeningsmetoden anvendes, var serotype-specifikke estimater for effektiviteten af 2 doser under 1-års alderen i Storbritannien 66 % (-29, 91 %) og 100 % (25, 100 %) for henholdsvis serotype 6B and 23F.
English: Prevenar 13 group
Danish: Prevenar 13gruppen
English: Higher frequency in some solicited systemic reactions was observed when Prevenar 13 was administered concomitantly with trivalent inactivated influenza vaccine (TIV) compared to TIV given alone (headache, chills, rash, decreased appetite, arthralgia, and myalgia) or Prevenar 13 given alone (headache, fatigue, chills, decreased appetite, and arthralgia).
Danish: Der observeredes en højere frekvens af nogle af de indberettede systemiske reaktioner, når Prevenar 13 blev administreret samtidig med trivalent inaktiveret influenzavaccine (TIV) sammenlignet med TIV givet alene (hovedpine, kulderystelser, udslæt, nedsat appetit, artralgi og myalgi) eller Prevenar 13 givet alene (hovedpine, træthed, udslæt, nedsat appetit og artralgi).
English: Tell your doctor, pharmacist or nurse if you or your child is taking, has recently taken or might take any other medicines, or has recently received any other vaccine.
Danish: Fortæl altid lægen, på apoteket eller sygeplejersken, hvis De eller Deres barn bruger anden medicin, har brugt anden medicin for nylig eller skal til at tage anden medicin eller for nylig har fået anden vaccine.
English: Children were vaccinated with Prevenar (3 doses one month apart from the age of 2 months), 46 of these children also received a 23-valent pneumococcal polysaccharide vaccine at the age of 15-18 months.
Danish: Børnene blev vaccineret med Prevenar (3 doser med en måneds mellemrum fra 2-måneders alderen), og 46 af disse børn fik også en 23-valent pneumokok polysaccharidvaccine i 15-18-måneders alderen.
English: Following the booster dose, antibody concentrations increased from the pre-booster level for all 13 serotypes.
Danish: Efter booster-dosen steg antistofkoncentrationerne fra præ-booster niveau for alle 13 serotyper.
English: Prevenar 13 is a pneumococcal vaccine given to:
Danish: Prevenar 13 er en pneumokokvaccine, som er med til at beskytte:
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 spædbørn, der er født meget for tidligt (født i eller før 28. svangerskabsuge), kan der være længere mellemrum end normalt mellem åndedragene i 2-3 dage efter vaccinationen.
English: Disease reduction, % 95% CI
Danish: Sygdomsreduktion i % 95 % CI
English: These data are intended to guide health care professionals in case of temporary temperature excursions.
Danish: Disse oplysninger er ment som vejledning til sundhedspersonale i tilfælde af, at produktet midlertidigt har været opbevaret uden for køleskab.
English: Store in a refrigerator (2C - 8C).
Danish: Opbevares i køleskab (2C - 8C).
English: Two doses, each of 0.5 ml, with an interval of at least 1 month between doses.
Danish: To doser, hver på 0,5 ml, med et interval på mindst 1 måned mellem doserne.
English: Talk to your doctor, pharmacist, or nurse before the vaccination if your child was born very prematurely (at or before 28 weeks of gestation), as longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Danish: Tal med lægen, apotekspersonalet eller sygeplejersken før vaccinationen, hvis Deres barn er født meget for tidligt (født i eller før 28. svangerskabsuge), da der kan være længere mellemrum end normalt mellem åndedragene i 2-3 dage efter vaccinationen.
English: This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent) (see section 5.1).
Danish: Vaccination med Prevenar 13 skal gives mindst 8 uger efter sidste dosis af Prevenar (7-valent) (se pkt.
English: The interval between the 13-valent pneumococcal conjugate vaccine (Prevenar 13) and the 23-valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
Danish: Intervallet mellem den 13-valente konjugerede pneumokokvaccine (Prevenar 13) og den 23-valente pneumokok polysaccharidvaccine bør ikke være mindre end 8 uger.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Immune responses in Special Populations
Danish: Immunrespons hos særlige populationer:
English: Adults 18 to 49 years of age
Danish: Voksne i alderen 18-49 år
English: NCKP: Vaccine-serotype IPD
Danish: NCKP: Vaccineserotype IPD
English: Children 5 to 17 years of age may receive a single dose of Prevenar 13 if they have been previously vaccinated with one or more doses of Prevenar.
Danish: Børn i alderen 5-17 år kan vaccineres med 1 enkelt dosis Prevenar 13, hvis de tidligere er blevet vaccineret med en eller flere doser Prevenar.
English: Metabolism and nutrition disorders: Very common:
Danish: Metabolisme og ernæring: Meget almindelig:
English: OPA GMT levels one year after Prevenar 13
Danish: OPA-GMT-niveauer ét år efter Prevenar 13
English: Data published by Public Health England showed that, four years after the introduction of Prevenar as a two dose primary infant series with booster dose in the second year of life and with a 94% vaccine uptake, there was a 98% (95% CI 95; 99) reduction in disease caused by the 7 vaccine serotypes in England and Wales.
Danish: Data publiseret af Public Health i England viste, at 4 år efter Prevenar blev introduceret som en primær spædbørnsserie med 2 doser samt boosterdosis i barnets andet leveår og med 94 % vaccinationstilslutning, var der i England og Wales en reduktion på 98 % (95 % CI 95; 99) i sygdom forårsaget af de 7 vaccineserotyper.
English: For serotype 3, the percentages of Prevenar 13 recipients with serum IgG ≥ 0.35 μg/ml were 98.2% (study 006) and 63.5% (study 004).
Danish: For serotype 3 var procentdelen af personer, der fik Prevenar 13, med serum IgG ≥ 0,35 μg/ml 98,2 % (studie 006) og 63,5 % (studie 004).
English: As recommended by the World Health Organization (WHO) the assessment of potential efficacy against IPD in infants and young children has been based on a comparison of immune responses to the seven common serotypes shared between Prevenar 13 and Prevenar, for which protective efficacy has been proven (for Prevenar (7-valent) efficacy in infants and children, see below).
Danish: Som anbefalet af Verdenssundhedsorganisationen (WHO) er vurderingen af den potentielle virkning mod IPD hos spædbørn og børn baseret på en sammenligning af immunrespons over for de syv fælles serotyper, som Prevenar 13 og Prevenar har til fælles, for hvilke en beskyttende virkning er blevet påvist (for Prevenar (7-valent) virkning hos spædbørn og børn, se nedenfor).
English: • if you or your child is allergic (hypersensitive) to the active substances or to any of the other ingredients in this medicine (listed in section 6) or to any other vaccine that contains diphtheria toxoid.
Danish: • hvis De eller Deres barn er overfølsom (allergisk) over for de aktive stoffer, eller et af de øvrige indholdsstoffer i Prevenar 13 (angivet i punkt 6) eller over for andre vacciner, som indeholder difteritoksoid.
English: Prevenar OPA GMT Relative to PPSV23
Danish: Prevenar OPA-GMT-titre i forhold til PPSV23
English: However, talk to your doctor, pharmacist, or nurse first.
Danish: De bør dog tale med Deres læge, apotek eller sygeplejerske først.
English: As with any vaccine, Prevenar 13 will not protect all persons who are vaccinated.
Danish: Ligesom det gælder for alle andre vacciner, vil Prevenar 13 ikke beskytte alle de personer, som bliver vaccineret.
English: In a surveillance study in France in children presenting with acute otitis media, changes in nasopharyngeal (NP) carriage of pneumococcal serotypes were evaluated following the introduction of Prevenar (7-valent) and subsequently Prevenar 13.
Danish: Et overvågningsstudie i Frankrig omfattende børn med akut otitis media evaluerede ændringer i den nasofaryngeale pneumokok-serotype-forekomst efter indførelse af Prevenar (7-valent) og senere Prevenar 13.
English: Hypotonic-hyporesponsive episode
Danish: Hypotonisk hyporesponsiv episode.
English: Both studies were randomised, double-blind, active-control studies in which infants were randomised to receive either Prevenar or control vaccine (NCKP, meningococcal serogroup C CRM-conjugate [MnCC] vaccine; FinOM, hepatitis B vaccine) in a four-dose series at 2, 4, 6, and 12-15 months of age.
Danish: Begge studier var randomiserede, dobbelt-blindede, aktivt kontrollerede studier, hvor spædbørn blev randomiseret til at få enten Prevenar eller kontrolvaccine (NCKP, meningokok serogruppe C CRM-konjugat [MnCC]vaccine; FinOM, hepatitis B-vaccine) i en serie med fire doser i 2-, 4-, 6- og 12-15-måneders alderen.
English: • 4.4 µg of polysaccharide for serotype 6B
Danish: • 4,4 µg polysaccharid for serotype 6B
English: Additional information in special populations: Apnoea in very premature infants ( 28 weeks of gestation) (see section 4.4).
Danish: Yderligere oplysninger om specielle populationer: Apnø hos spædbørn, der er født meget for tidligt ( 28 ugers svangerskab) (se pkt.
English: Overall, no significant differences in frequencies of adverse reactions were seen when Prevenar 13 was given to adults previously vaccinated with the pneumococcal polysaccharide vaccine.
Danish: Samlet set sås ingen signifikante forskelle i frekvensen af bivirkninger, når Prevenar 13 blev givet til voksne, der tidligere var blevet vaccineret med pneumokok polysaccharidvaccine.
English: However, 3 (serotypes 1, 5 and 6A) of the 6 additional serotypes showed lower IgG GMC and OPA GMT when compared with children who had received at least one previous vaccination with
Danish: Tre serotyper (serotype 1, 5 og 6A) af de seks yderligere serotyper udviste imidlertid lavere IgG-GMC og OPA-GMT sammenlignet med børn, som havde fået mindst en tidligere vaccination med Prevenar 13.
English: 18-49 Years N=836-866
Danish: 18-49 år N=836-866
English: For each of the 6 additional serotypes, Prevenar 13 elicited OPA titres ≥ 1:8 in 91.4% to 100% of vaccinees one month after the primary series in studies 004/006.
Danish: For hver af de 6 yderligere serotyper fremkaldte Prevenar 13 OPA titre ≥ 1:8 i 91,4 % til 100 % af de vaccinerede en måned efter den primære serie i studie 004/006.
English: • Severe allergic reaction including shock (cardiovascular collapse); angioedema (swelling of lips, face or throat)
Danish: • Svær allergisk reaktion, herunder shock (hjertekollaps), angioødem (hævelse af læber, ansigt eller svælg)
English: Additionally, all 13 serotypes met the pre-defined non-inferiority criterion for IgG GMCs (lower bound of the 97.5% CI of GMC ratio [GMR] was greater than 0.5).
Danish: Derudover opfyldte alle 13 serotyper det prædefinerede non-inferioritetskriterium for IgG GMC'er (den nedre grænse af 97,5 % CI af GMC-ratio [GMR] var større end 0,5).
English: Vaccine serotypes: 98% All serotypes: 77%
Danish: Vaccineserotyper: 98 % Alle serotyper: 77 %
English: Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to Prevenar 13 suggest that administration of paracetamol concomitantly or within the same day of vaccination may reduce the immune response to Prevenar 13 after the infant series.
Danish: Data fra et klinisk studie efter markedsføring, som vurderede virkningen af profylaktisk brug af antipyretika (ibuprofen og paracetamol) på immunresponset på Prevenar 13, antyder, at administration af paracetamol, samtidig med eller samme dag, som vaccinen gives, kan reducere immunresponset på Prevenar 13 efter børnevaccinationsserierne.
English: The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children ≥ 2 years of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness, or those who are immuno-compromised) placing them at higher risk for invasive disease due to Streptococcus pneumoniae.
Danish: Anvendelsen af konjugeret pneumokokvaccine erstatter ikke brugen af 23-valent pneumokok polysaccharidvaccine til børn ≥ 2 år gamle med lidelser (såsom seglcelleanæmi, aspleni, hiv-infektion, kronisk sygdom eller immunkompromitterede), som giver dem højere risiko for invasiv sygdom på grund af Streptococcus pneumoniae.
English: Prevenar 13 elicited increased antibody levels after each dose of Prevenar 13.
Danish: Prevenar 13 fremkaldte et forhøjet antistofniveau efter hver dosis Prevenar 13.
English: A fourth injection (booster) is recommended 6 months after the third injection.
Danish: Det anbefales at få en fjerde indsprøjtning (booster) 6 måneder efter den tredje indsprøjtning.
English: Immunogenicity studies in adults ≥18 years and the elderly
Danish: Immunogenicitetsstudier hos voksne fra 18 år samt ældre personer
English: • Vomiting (for those 50 years and older); fever (for those 30 years and older)
Danish: • Opkastning (hos voksne fra 50 år og ældre), feber (hos voksne fra 30 år og ældre).
English: Severe vaccination-site pain/tenderness and severe limitation of arm movement was very common in adults 18 to 39 years and common in all other age groups.
Danish: Svær smerte/ømhed på vaccinationsstedet og svær begrænsning i armens bevægelighed var meget almindelig hos voksne i alderen 18-39 år og almindelig i alle andre aldersgrupper.
English: Children younger than 2 years old should receive the appropriate-for-age Prevenar 13 vaccination series (see section 4.2).
Danish: Børn under 2 år bør have den Prevenar 13-vaccinationsserie, der er passende til alderen (se pkt.
English: The vaccine should be shaken well to obtain a homogeneous white suspension prior to expelling air from the syringe, and should be inspected visually for any particulate matter and/or variation of physical aspect prior to administration.
Danish: Vaccinen skal rystes grundigt for at opnå en homogen hvid suspension, før luften trykkes ud af sprøjten, og den skal inspiceres visuelt for eventuelle partikler og/eller variationer i fysisk udseende før administration.
English: * Patients with at least 2 of the following: Cough; purulent sputum, temperature >38°C or <36.1°C; pneumonia (auscultatory findings); leukocytosis; C-reactive protein value >3 times the upper limit of normal; hypoxemia with a partial oxygen pressure <60 mm Hg while breathing room air.
Danish: * Patienter med mindst 2 af følgende: Hoste; purulent sputum, temperatur > 38 °C eller < 36,1°C; pneumoni (auskultationsfund); leukocytose; C-reaktivt protein > 3 gange den øvre normalgrænse; hypoksæmi med et partielt ilttryk < 60 mm Hg ved indånding af rumluft.
English: Manufacturer responsible for batch release: Wyeth Pharmaceuticals New Lane
Danish: Fremstiller ansvarlig for batchfrigivelse: Wyeth Pharmaceuticals New Lane
English: The vaccine should be shaken well to obtain a homogeneous white suspension and should be inspected visually for any particulate matter and/or variation of physical aspect prior to administration.
Danish: Vaccinen skal rystes grundigt for at opnå en homogen hvid suspension, og den skal inspiceres visuelt for eventuelle partikler og/eller variationer i fysisk udseende før administration.
English: Shake well before use.
Danish: Omrystes grundigt før anvendelse.
English: Children < 5 years of age.
Danish: Børn < 5 år.
English: Total episodes
Danish: Totalt antal episoder
English: Children aged 12-23 months Two doses, each of 0.5 ml, with an interval of at least 2 months between doses (see section 5.1).
Danish: Børn i alderen 12-23 måneder To doser, hver på 0,5 ml, med et interval på mindst 2 måneder mellem doserne (se pkt.