FrancophonIA/ELRC3.0 huggingface dataset:
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres af medlemsstaternes kompetente myndigheder i overensstemmelse med proceduren i kapitel 4 i afsnit III i direktiv 2001/83 / EF i samarbejde med referencemedlemsstaten.
English: These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Danish: Disse ændringer til de relevante afsnit af produktinformationen er resultatet af henvisningsproceduren.
English: Therefore, the administration of <product> to prevent pneumonia is not recommended.
Danish: Derfor anbefales administration af <produkt> til forebyggelse af lungebetændelse ikke.
English: [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Danish: [For alle produkter i bilag I ændres den eksisterende produktinformation (indsættelse, udskiftning eller sletning af teksten, hvor det er relevant) for at afspejle den aftalte formulering som angivet nedenfor]
English: No data from clinical studies are available to demonstrate that the use of <product> can prevent pneumonia.
Danish: Der foreligger ingen data fra kliniske undersøgelser, der kan påvise, at brugen af <produkt> kan forebygge lungebetændelse.
English: The use of <product> in the prevention of pneumonia is not recommended, as no data from clinical studies are available to demonstrate such effect.
Danish: Anvendelse af <produkt> til forebyggelse af lungebetændelse anbefales ikke, da der ikke foreligger data fra kliniske undersøgelser, der kan påvise en sådan virkning.
English: Annex III Amendments to relevant sections of the Product Information
Danish: Bilag III Ændringer til relevante afsnit af produktinformationen
English: Prophylaxis of recurrent upper respiratory tract infections (RTI) in <age group>.
Danish: Profylakse af tilbagevendende øvre luftvejsinfektioner (RTI) hos <aldersgruppe>.
English: Amendments to relevant sections of the Product Information
Danish: Ændringer til relevante afsnit af produktinformationen
English: What you need to know before you use <product>
Danish: Det skal <De> <du> vide, før <De> <du> begynder at <tage> <bruge> <produkt>
English: [For products authorised in the prophylaxis of unspecified recurrent RTI a warning should be added as follows and related changes should be implemented as needed throughout the PL]
Danish: [For produkter, der er godkendt til profylakse af uspecificeret tilbagevendende RTI, skal en advarsel tilføjes som følger og relaterede ændringer skal implementeres efter behov i hele indlægssedlen]
English: 4.4 Special warnings and precautions for use [For products authorised in the prophylaxis of unspecified recurrent RTI a warning should be added as follows and related changes should be implemented as needed throughout the SmPC]
Danish: 4.4 Særlige advarsler og forholdsregler vedrørende brugen [For produkter, der er godkendt til profylakse af uspecificeret tilbagevendende RTI, skal en advarsel tilføjes som følger, og relaterede ændringer skal implementeres efter behov i hele produktresuméet]
English: [Related changes should be implemented as needed throughout the SmPC]
Danish: [Relaterede ændringer skal implementeres efter behov i hele Produktresuméet efter behov]
English: [With regards to the age group, minimal age should be reflected as follows: Luivac and associated names: children from 4 years of age Buccalin and associated names: children from 2 years of age For Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum and their associated names no change is needed to the minimal age currently authorised; however the age cut off should also be reflected in the indication, in line with the SmPC guideline.]
Danish: For Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum og deres tilhørende navne er ingen ændring nødvendig for den minimale alder, der for øjeblikket er godkendt; dog bør aldersbegrænsningen også afspejles i indikationen, i overensstemmelse med retningslinjerne for produktresuméer.]
English: [With regards to the age group, minimal age should be reflected as follows: Luivac and associated names: children from 4 years of age Buccalin and associated names: children from 2 years of age For Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum and their associated names no change is needed to the minimal age currently authorised; however the age cut off should also be reflected in the indication] [Related changes should be implemented as needed throughout the PL]
Danish: For Respivax, Lantigen B, Ismigen, Broncho-Vaxom, Ribomunyl, Polyvaccinum og deres tilhørende navne er ingen ændring nødvendig for den minimale alder, der for øjeblikket er godkendt; dog bør aldersbegrænsningen også afspejles i indikationen] [Relaterede ændringer skal implementeres efter behov i hele indlægssedlen]
English: 4.1 Therapeutic indications [For all products, indications in respiratory tract conditions should be replaced by the below ones for adults and for children]
Danish: 4.1 Terapeutiske indikationer [For alle produkter skal luftvejsindikationer erstattes af nedenstående for voksne og børn] FOR VOKSNE [For produkt med luftvejsindikationer hos voksne, skal indikationen revideres som følger] Profylakse af tilbagevendende luftvejsinfektioner (RTI) hos voksne.
English: What <product> is and what it is used for [For all products, indications in respiratory tract conditions should be replaced by the below ones for adults and for children]
Danish: Virkning og anvendelse [For alle produkter skal luftvejsindikationer erstattes af nedenstående for voksne og børn] FOR VOKSNE [For produkt med luftvejsindikationer hos voksne, skal indikationen revideres som følger] Forebyggelse af tilbagevendende luftvejsinfektioner (RTI) hos voksne.
English: January 2005 to December 2007.
Danish: Januar 2005 til december 2007.
English: Based on a 5-year duration of protection.
Danish: Baseret på en beskyttelsesvarighed på 5 år.
English: Results for study 004 were similar.
Danish: Resultaterne for studie 004 var de sammenlignelige.
English: oC. Other in-use storage times and conditions are the responsibility of the user.
Danish: oC. Andre opbevaringstider og betingelser under anvendelse er brugerens ansvar.
English: Complete effectiveness for routine 2+1 schedule not yet available.
Danish: Fuldstændig effektivitet for rutine 2+1 planen endnu ikke tilgængelig.
English: After first use:
Danish: Efter første anvendelse:
English: Vaccine efficacy October 1995 to April 20, 1999 October 1995 to April 30, 1998
Danish: Vaccinens effekt Oktober 1995 til 20. april 1999 Oktober 1995 til 30. april 1998
English: Date of first authorisation: 09 December 2009 Date of latest renewal: 18 September 2014
Danish: Dato for første markedsføringstilladelse: 9. december 2009 Dato for seneste fornyelse: 18. september 2014
English: UK (England & Wales)
Danish: UK (England og Wales)
English: Calculated vaccine effectiveness as of June 2008 (Broome method).
Danish: Beregnet effektivitet af vaccinen pr. juni 2008 (Broome-metoden).
English: • if you or your child has a severe infection with a high temperature (over 38°C).
Danish: • hvis De eller Deres barn har en alvorlig infektion med høj temperatur (over 38 °C).
English: One single dose.
Danish: En enkelt dosis.
English: This does not constitute a sign of deterioration.
Danish: Dette er ikke tegn på nedbrydning.
English: ** p<0.005 to cover 6A where p=0.002
Danish: ** p<0,005 for at dække 6A hvor p=0,002
English: Do not use if the content appears otherwise.
Danish: Må ikke anvendes, hvis indholdet fremtræder på anden måde.
English: These observations are consistent with adequate priming (the induction of immunologic memory).
Danish: Disse observationer er forenelige med tilstrækkelig priming (induktion af immunologisk hukommelse).
English: • You will be told when your child should come back for the next injection.
Danish: • De vil blive informeret om, hvornår Deres barn skal have den næste indsprøjtning.
English: Persons ≥ 65
Danish: Personer ≥ 65
English: If this applies to you or your child, then the vaccination will be postponed until you or your child is feeling better.
Danish: Hvis dette gælder for Dem eller Deres barn, vil vaccinationen blive udskudt, indtil De eller Deres barn har det bedre.
English: The study demonstrated that safety and immunogenicity were generally comparable with observations made in studies of intramuscular administration.
Danish: Studiet viste, at sikkerhed og immunogenicitet generelt var sammenlignelige med observationer fundet i studier med intramuskulær administration.
English: The vaccine works by helping the body to make its own antibodies, which protect you or your child against these diseases.
Danish: Vaccinen virker ved at hjælpe kroppen med at danne sine egne antistoffer, som beskytter Dem eller Deres barn mod disse sygdomme.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Danish: Da fordelen ved vaccination er høj i denne gruppe spædbørn, bør vaccination ikke tilbageholdes eller udskydes.
English: Per 100,000 person-years of observation.
Danish: Pr. 100.000 personår med observation.
English: The reductions ranged between 34% and 62% depending on serotype and antibiotic.
Danish: Reduktionen var mellem 34% til 62% afhængig af serotype og antibiotika.
English: After first use, the product may be stored in a refrigerator for a maximum of 28 days.
Danish: Efter første anvendelse kan produktet opbevares i køleskab i højst 28 dage.
English: Incidence per 100,000 personyears of observation (PYO)
Danish: Incidens pr. 100.000 personår med observation (PYO)
English: Individuals with the conditions described below have an increased risk of pneumococcal disease.
Danish: Personer med de tilstande, der er beskrevet nedenfor, har en øget risiko for pneumokoksygdom.
English: Different injectable vaccines should always be given at different vaccination sites.
Danish: Forskellige vacciner til injektion skal altid gives på forskellige vaccinationssteder.
English: Administer the entire dose.
Danish: Hele dosen administreres.
English: Bacteria can be responsible for 60-70% of clinical episodes of AOM.
Danish: Bakterier kan være ansvarlige for 60-70 % af kliniske tilfælde af AOM.
English: Once opened, the product may be stored for a maximum of 28 days at 2-8
Danish: Efter åbning kan produktet opbevares i højst 28 dage ved 2-8
English: The CAPiTA study enrolled volunteers ≥ 65 years of age whose demographic and health characteristics may differ from those seeking vaccination.
Danish: CAPiTA-studiet inkluderede frivillige forsøgspersoner ≥ 65 år, hvis demografiske og sundhedsmæssige karakteristik kan adskille sig fra dem, der ønsker vaccination.
English: These reactions were mostly moderate (less than or equal to 39°C) and transient.
Danish: Reaktionerne var overvejende moderate (under eller lig med 39 °C) og forbigående.
English: See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes.
Danish: 4.4 og 5.1 vedrørende oplysninger om beskyttelse mod specifikke pneumokokserotyper.
English: Unvaccinated Children (12-23 months)
Danish: Uvaccinerede børn (12-23 måneder)
English: Decreased appetite
Danish: Nedsat appetit.
English: Children < 5
Danish: Børn < 5
English: Prevenar 13 is stable at temperatures up to 25°C for four days.
Danish: Prevenar 13 kan opbevares ved temperaturer op til 25 C i op til 4 dage.
English: Because these reactions were derived from spontaneous reports, the frequencies could not be determined and are thus considered as not known.
Danish: Da bivirkningerne er baseret på spontane indberetninger, kan hyppigheden ikke bestemmes og angives derfor som ikke kendt.
English: Read all of this leaflet carefully before you or your child receives this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De eller Deres barn får vaccinen, da den indeholder vigtige oplysninger.
English: The immunogenicity after two doses in infants has been documented in four studies.
Danish: Immunogenicitet hos spædbørn efter to doser er blevet dokumenteret i fire studier.
English: Immune responses after subcutaneous administration
Danish: Immunrespons efter subkutan administration
English: S. pneumoniae is one of the most common causes of bacterial AOM worldwide.
Danish: S. pneumoniae er en af de mest almindelige årsager til bakteriel AOM på verdensplan.
English: Vaccines were administered at 1 month intervals.
Danish: Vaccinerne blev indgivet med intervaller på 1 måned.
English: At the end of this period Prevenar 13 should be used or discarded.
Danish: Efter denne periode skal Prevenar 13 enten anvendes eller bortskaffes.
English: Adults should receive one injection.
Danish: Voksne skal have én indsprøjtning.
English: Immune responses to the additional 6 serotypes were also measured.
Danish: Immunresponset over for de 6 yderligere serotyper blev også målt.
English: IRR, also referred to as vaccine preventable disease incidence, is the number of cases of vaccine preventable disease per 100,000 person-years of observation.
Danish: IRR, som også kaldes vaccineforebyggelig sygdomsincidens, er antallet af tilfælde af vaccineforebyggelig sygdom pr. 100.000 personår med observation.
English: First episode of VT-IPD
Danish: Første episode af VT-IPD
English: The frequency is defined as follows: very common ( 1/10), common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100), rare ( 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).
Danish: Frekvensen defineres som følger: meget almindelig ( 1/10); almindelig ( 1/100 til < 1/10); ikke almindelig ( 1/1.000 til < 1/100); sjælden (> 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Efficacy was demonstrated for the primary and secondary endpoints in the per protocol population (Table 5).
Danish: Effekt blev påvist for de primære og sekundære endepunkter i per protokol-populationen (tabel 5).
English: Arthralgia; myalgia
Danish: Artralgi, myalgi.
English: HIV infection
Danish: Hiv-infektion
English: Table 2: Serotype specific number of cases and incidence reductions of IPD in 2013/14 compared to 2008/09-2009/10 (2008/10) by age in England and Wales
Danish: Tabel 2: Antal serotype-specifikke tilfælde og reduktioner i hyppigheden af IPD i 2013/14 sammenlignet med 2008/09-2009/10 (2008/10) efter alder i England og Wales
English: There was no carriage of serotypes 1 and 5 observed.
Danish: Der observeredes ingen bærere af serotyperne 1 og 5.
English: Local reactions and systemic events were solicited daily after each vaccination for 14 days in 6 studies and 7 days in the remaining study.
Danish: Lokale reaktioner og systemiske bivirkninger blev registreret dagligt i 14 dage efter hver vaccination i 6 kliniske studier og i 7 dage i det sidste studie.
English: Pharmacotherapeutic group: vaccines, pneumococcal vaccines; ATC code: J07AL02
Danish: Farmakoterapeutisk klassifikation: Vacciner, pneumokokvacciner; ATC-kode: J07AL02
English: Prevenar 13 can be given at the same time as other childhood vaccines; in this case, different vaccination sites should be used.
Danish: Prevenar 13 kan gives på samme tidspunkt som andre børnevacciner; i dette tilfælde skal forskellige injektionssteder anvendes.
English: A reduction in carriage was also seen for serotype 3 (2.5% vs 1.1%; p=0.1).
Danish: En reduktion i antal bærere sås også for serotype 3 (2,5 % vs 1,1 %; p = 0,1).
English: This is a multidose presentation.
Danish: Dette er en flerdosis pakning.
English: The incidence in older, predominantly non-vaccinated children (>5 years) did not change over the duration of the study.
Danish: Hyppigheden hos ældre og overvejende ikke vaccinerede børn (> 5 år) ændrede sig ikke i løbet af studiet.
English: During storage, a white deposit and clear supernatant can be observed.
Danish: Under opbevaring kan der observeres et hvidt bundfald og en klar supernatant.
English: drowsiness; restless sleep
Danish: døsighed, urolig søvn.
English: Significant incidence reductions were also observed in older age groups who had not been vaccinated with Prevenar 13 (indirect effect).
Danish: Der blev også observeret signifikante reduktioner i hyppigheden hos ældre aldersgrupper, som ikke var blevet vaccineret med Prevenar 13 (indirekte virkning).
English: Safety in 354 previously unvaccinated children (7 months to 5 years of age) was also assessed.
Danish: Sikkerheden hos 354 børn uden tidligere vaccination (i alderen 7 måneder til 5 år) blev også vurderet.
English: • has any bleeding problems or bruises easily.
Danish: • har blødningsproblemer eller let får blå mærker.
English: Adverse reactions from clinical studies
Danish: Uønskede reaktioner fra kliniske studier
English: * 95% CI inflated from a Poisson interval based on over-dispersion of 2.1 seen from modelling of 2000-06 pre-Prevenar all IPD data.
Danish: * 95 % CI opskaleret fra et Poisson-interval baseret på en 2,1 overspredning ud fra modellering af alle præ-Prevenar IPD-data 2000-06.
English: The most commonly reported adverse reactions in children 6 weeks to 5 years of age were vaccination-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep.
Danish: De hyppigst indberettede bivirkninger hos børn i alderen 6 uger til 5 år var reaktioner på vaccinationsstedet, feber, irritabilitet, nedsat appetit og forøget og/eller nedsat søvn.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Danish: Som med alle vacciner til injektion skal relevant medicinsk behandling og overvågning altid være til umiddelbar rådighed i tilfælde af en sjælden anafylaktisk reaktion efter administration af vaccinen.
English: Infants, children, and adolescents previously vaccinated with Prevenar
Danish: Spædbørn, børn og unge, som tidligere er vaccineret med Prevenar
English: NNV also incorporates the length of the trial or duration of protection and is calculated as 1 divided by the product of the IRR and duration of protection (or length of trial) (=1/(IRR × duration).
Danish: NNV inkorporerer også forsøgslængden eller beskyttelsesvarigheden og er beregnet som 1 divideret med produktet af IRR og beskyttelsesvarighed (eller forsøgslængde) (=1/(IRR × varighed).
English: Prevenar 13 should not be given:
Danish: Prevenar 13 må ikke gives:
English: While direct cause-and-effect cannot be inferred from observational analyses of this type, these findings suggest that Prevenar plays an important role in reducing the burden of mucosal disease (AOM and pneumonia) in the target population.
Danish: Mens et direkte årsag-virkningsforhold ikke kan udledes fra observationsanalyser af denne type, tyder disse fund på, at Prevenar spiller en vigtig rolle ved at reducere byrden af slimhindesygdomme (AOM og pneumoni) hos målpopulationen.
English: Other adverse events previously observed in infants and children 6 weeks to 5 years of age may also be applicable to this age group but were not seen in this study possibly due to the small sample size.
Danish: Andre bivirkninger, som tidligere er set hos børn i alderen 6 uger til 5 år, kan være relevante for denne aldersgruppe også, men blev ikke set i dette studie, hvilket kan skyldes det begrænsede antal børn i studiet.
English: Acute Otitis Media
Danish: Akut otitis media
English: This will help to lower some of the side effects of Prevenar 13.
Danish: Det vil hjælpe med at reducere nogle af bivirkningerne ved Prevenar 13.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apoteket til råds, før De får dette lægemiddel.
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: UNIK IDENTIFIKATOR - 2D-STREGKODE
English: The protective efficacy of Prevenar 13 against IPD has not been studied.
Danish: Den beskyttende virkning af Prevenar 13 mod IPD er ikke blevet undersøgt.
English: Corrected for proportion of samples serotyped, missing age, denominator compared with 2009/10, and for the trend in total invasive pneumococcal disease up to 2009/10 (after which no trend correction was applied).
Danish: Korrigeret for andelen af serotypebestemte prøver, manglende alder, niveau sammenlignet med 2009/10 og for udviklingen i total invasiv pneumokoksygdom frem til 2009/10 (hvorefter der ikke blev anvendt tendenskorrigering).
English: Prevenar 13 has no or negligible influence on the ability to drive and use machines.
Danish: Prevenar 13 påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Furthermore, in this study statistically significantly greater OPA GMTs were demonstrated for 10 of the 12 serotypes in common.
Danish: Desuden blev der i dette studie påvist statistisk signifikant større OPA-GMT'er for 10 af de 12 fælles serotyper.
English: For vaccine serotypes, protection against otitis media is expected to be lower than protection against invasive disease.
Danish: For vaccine-serotyperne forventes beskyttelsen mod otitis media at være mindre end beskyttelsen mod invasiv sygdom.
English: For the six additional serotypes, these values were compared with the lowest response among all of the seven common serotypes in the Prevenar recipients.
Danish: For de seks yderligere serotyper blev disse værdier sammenlignet med det laveste respons blandt alle de syv fælles serotyper hos Prevenar-behandlede forsøgspersoner.
English: The study was not designed to demonstrate efficacy in subgroups, and the number of subjects ≥ 85 years of age was not sufficient to demonstrate efficacy in this age group.
Danish: Studiet var ikke designet til at påvise-effekten i undergrupper, og antallet af forsøgspersoner ≥ 85 år var ikke tilstrækkeligt til at påvise effekt i denne aldersgruppe.
English: NCKP: Acute Otitis Media (AOM) Total episodes
Danish: NCKP: Akut otitis media (AOM) Totalt antal episoder
English: The clinical relevance of the lower GMCs and GMTs is currently unknown.
Danish: Den kliniske betydning af lavere GMC og GMT kendes ikke.
English: 4 x 0.5 ml doses
Danish: 4 x 0,5 ml doser
English: The clinical relevance of the antibody levels elicited by Prevenar 13 in these special populations is unknown.
Danish: Den kliniske relevans af de antistofniveauer, som Prevenar 13 fremkaldte hos disse særlige populationer, er ukendt.
English: The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine into your arm or your child's arm or leg muscle.
Danish: Lægen eller sygeplejersken vil indsprøjte den anbefalede dosis (0,5 ml) af vaccinen i musklerne i Deres arm. Børn vil få indsprøjtningen i muskler i armen eller benet.
English: Functional antibody titers (OPA titers) were not measured in this study.
Danish: Funktionelle antistoftitre (OPA-titre) blev ikke målt i dette studie.
English: The reported incidence of community-acquired pneumonia (CAP) and IPD in Europe varies by country, increases with age from 50 years and is highest in individuals aged ≥ 65 years.
Danish: Den rapporterede hyppighed af samfundserhvervet pneumoni (community-acquired pneumonia (CAP)) og IPD i Europa varierer fra land til land, øges fra 50 års-alderen og er højest hos personer i alderen ≥ 65 år.
English: Prevenar 13 is estimated to cover over 90% of serotypes causing antimicrobial-resistant IPD.
Danish: Det estimeres, at Prevenar 13 dækker over 90 % af de serotyper, som forårsager antimikrobielresistent IPD.