FrancophonIA/ELRC3.0 huggingface dataset:
English: Over 96% of patients taking Vosevi in one study tested negative for HCV (their blood tests did not show any sign of the virus) after 12 weeks of treatment, compared with none of the patients who received placebo (a dummy treatment).
Danish: Resultaterne fra én undersøgelse viste, at over 96 % af de patienter, der fik Vosevi, testede negativ for HCV efter 12 ugers behandling (deres blodprøver viste ingen tegn på virusset), mens ingen af de patienter, der fik placebo (et ikke-aktivt stof), blev testet negativ.
English: Vosevi is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus (HCV).
Danish: Vosevi er et lægemiddel mod virus (et antiviralt lægemiddel), der anvendes til behandling af voksne med kronisk hepatitis C, der er en smitsom sygdom, som angriber leveren og forårsages af hepatitis Cvirus (HCV).
English: For practical information about using Vosevi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Vosevi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In two further studies between 95 and 96% of Vosevi patients tested negative for the virus, compared with 96 to 98% of patients taking sofosbuvir/velpatasvir.
Danish: Resultaterne fra to yderligere undersøgelser viste, at 95-96 % af de Vosevibehandlede patienter testede negativ for virusset, mens dette var tilfældet for 96-98 % af de patienter, der alene fik sofosbuvir/velpatasvir.
English: What benefits of Vosevi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vosevi?
English: Additionally, Vosevi was shown to be very effective at eliminating the hepatitis C virus in patients in whom previous treatment with a NS5A inhibitor failed.
Danish: Derudover er det påvist, at Vosevi er meget effektivt til at fjerne hepatitis C-virus hos patienter, der tidligere har oplevet behandlingssvigt med en NS5A-hæmmer.
English: Vosevi has been shown in four main studies of 1,459 patients to be effective at clearing all six varieties (genotypes) of the hepatitis C virus, including in patients with liver cirrhosis and those who have previously tried other direct-acting antivirals.
Danish: Resultaterne fra fire hovedundersøgelser af 1.459 patienter viser, at Vosevi er effektivt til at bekæmpe alle seks genotyper (varianter) af hepatitis C-virusset, også hos patienter med skrumpelever og patienter, der tidligere har fået andre direkte virkende antivirale lægemidler.
English: How is Vosevi used?
Danish: Hvordan anvendes Vosevi?
English: Over 97% of patients taking Vosevi in a second study tested negative, compared with 90% of patients taking only sofosbuvir/velpatasvir.
Danish: Resultaterne fra en anden undersøgelse viste, at 97 % af de patienter, der fik Vosevi, testede negativ, mens dette var tilfældet for 90 % af de patienter, der alene fik sofosbuvir/velpatasvir.
English: • dabigatran etexilate (medicine for preventing blood clots);
Danish: • dabigatranetexilat (lægemiddel til forebyggelse af blodpropper)
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vosevi have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Vosevi.
English: Vosevi has been shown to be highly effective in clearing the hepatitis C virus of all genotypes from the blood of both previously treated and untreated patients, including patients who have cirrhosis.
Danish: Det er påvist, at Vosevi er meget effektivt til at fjerne alle genotyper af hepatitis C-virus fra blod, både hos patienter, der tidligere er blevet behandlet, og hos dem, der ikke tidligere er blevet behandlet.
English: • St John's wort (a herbal remedy used for depression and anxiety).
Danish: • prikbladet perikon (et naturlægemiddel til behandling af depression og angst).
English: How does Vosevi work?
Danish: Hvordan virker Vosevi?
English: • ethinyl oestradiol-containing products (such as contraceptive medicines);
Danish: • ethinyløstradiol-holdige lægemidler (f.eks. præventionsmidler)
English: • rosuvastatin (medicine for lowering cholesterol in the blood);
Danish: • rosuvastatin (kolesterolsænkende medicin)
English: The clinical relevance of these interactions is unknown.
Danish: Den kliniske relevans af disse interaktioner er ukendt.
English: • You will be told when your child should come back for the next injection
Danish: • De vil blive informeret om, hvornår Deres barn bør komme tilbage for at få den næste injektion
English: Using other medicines/vaccines:
Danish: Brug af anden medicin/vacciner:
English: Each individual pack cannot be sold separately.
Danish: De enkelte pakninger må ikke sælges enkeltvis.
English: Epidemiological data between 1988 and 2003 indicated that in Europe coverage is lower and varies from country to country.
Danish: Epidemiologiske data fra 1988 til 2003 indikerer, at dækningen i Europa er lavere og varierer fra land til land.
English: - if your child has any bleeding problems.
Danish: - hvis Deres barn har blødningsproblemer.
English: - if your child has a severe infection with a high temperature (over 38°C).
Danish: - hvis Deres barn har en alvorlig infektion med en høj temperatur (over 38 °C).
English: The vaccine is a homogeneous white suspension.
Danish: Vaccinen er en homogen, hvid suspension.
English: If this applies to your child, then the vaccination will be postponed until your child is feeling better.
Danish: Hvis dette gælder for Deres barn, vil vaccinationen blive udskudt, indtil Deres barn har det bedre.
English: Do not use if the
Danish: Må ikke anvendes, hvis
English: • Fever of 39°C or higher
Danish: • Feber på 39 ° eller højere
English: Prevenar is not intended for use in adults.
Danish: Prevenar er ikke beregnet til brug hos voksne.
English: The need for a booster dose after these immunisation schedules has not been established.
Danish: Behovet for en booster dosis efter disse immuniseringsplaner er ikke fastslået.
English: Official batch release: in accordance with Article 114 of Council Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: Officiel batchfrigivelse: i overensstemmelse med artikel 114 i Rådets direktiv 2001/83/EØF med ændringer vil den officielle batchfrigivelse blive foretaget af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: The vaccine works by helping the body to make its own antibodies, which protect your child against
Danish: Vaccinen virker ved at hjælpe kroppen med at danne sine egne antistoffer, som beskytter Deres barn
English: Each 0.5 ml dose contains:
Danish: Hver 0,5 ml dosis indeholder:
English: HOW PREVENAR IS GIVEN
Danish: SÅDAN SKAL PREVENAR GIVES
English: • A fourth injection (booster) will be given between 11 and 15 months of age
Danish: • En fjerde injektion (booster) gives i alderen mellem 11 og 15 måneder
English: 2 micrograms
Danish: 2 mikrogram
English: The decrease in the incidence of IPD seen in older children may be partly due to naturally acquired immunity.
Danish: Faldet i incidensen af IPD, som ses hos ældre børn, kan til dels skyldes naturligt erhvervet immunitet.
English: The marketing authorisation holder must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is
Danish: Indehaveren af markedsføringstilladelsen skal tilsikre, at systemet til bivirkningsovervågning, præsenteret i afsnit 1.8.1 i markedsføringstilladelse, er på plads og fungerer, før og mens produktet er
English: A subset of children in this study were followed until they reached 4 to 5 years of age.
Danish: En delmængde af børnene i denne undersøgelse blev fulgt, indtil de fyldte 4 til 5 år.
English: Also safety in previously unvaccinated older children has been assessed.
Danish: Også sikkerheden for uvaccinerede ældre børn er blevet vurderet.
English: Read all of this leaflet carefully before your child receives this vaccine.
Danish: Læs denne indlægsseddel grundigt, inden Deres barn får denne vaccine.
English: The vaccine serotype coverage in the paediatric population decreases with increasing age.
Danish: Vaccinens serotype dækning i den pædiatriske population falder med stigende alder.
English: WHO technical report No 927, 2005; Appendix serological criteria for calculation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.
Danish: Teknisk rapport fra WHO, nr. 927, 2005: Appendix serological criteria for calculation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.
English: • The first injection may be given from 2 months of age
Danish: • Den første injektion kan gives fra 2 måneds alderen
English: Store in a refrigerator (2C - 8C).
Danish: Opbevares i køleskab (2°C - 8°C).
English: Effectiveness (no microbiological confirmation of diagnosis was performed) against non-bacteraemic pneumonia was also assessed.
Danish: Effekt (ingen mikrobiologisk dokumentation af diagnosen blev foretaget) over for ikke-bakteriel pneumoni blev også bedømt.
English: Unvaccinated infants and children over 7 months of age
Danish: Ikke vaccinerede spædbørn og børn over 7 måneder
English: The majority of the safety experience comes from the efficacy trial in which 17,066 infants received 55,352 doses of Prevenar.
Danish: Størstedelen af erfaringerne omkring sikkerhed kommer fra undersøgelsen af virkningen, hvori 17.066 børn fik 55.352 doser Prevenar.
English: • CONDITIONS AND RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
English: Antipyretic treatment should be initiated whenever warranted or when the temperature rises above 39°C.
Danish: Febersænkende behandling bør indledes efter behov, eller når temperaturen stiger til over 39C.
English: Upon storage, a white deposit and clear supernatant can be observed.
Danish: Ved opbevaring kan der konstateres et hvidt bundfald og klart supernatant.
English: Acute otitis media (AOM) is a common childhood disease with different aetiologies.
Danish: Akut otitis media (AOM) er en almindelig børnesygdom med forskellig ætiologi.
English: Previously unvaccinated older infants and children:
Danish: Tidligere ikke-vaccinerede ældre spædbørn og børn:
English: The immunisation schedules for Prevenar should be based on official recommendations.
Danish: Immuniseringsplanerne for Prevenar skal baseres på anbefalingerne fra myndighederne.
English: A minor infection, such as a cold, should not be a problem.
Danish: En mildere infektion, såsom en forkølelse, bør ikke være et problem.
English: Human data on the use during pregnancy or lactation and animal reproduction studies are not available.
Danish: Der foreligger ingen humane data vedrørende brug under graviditet og amning, og der foreligger ingen reproduktionsundersøgelser hos dyr.
English: At the booster, some suppression of Hib antibody level was observed but all children had protective levels.
Danish: Ved booster dosis blev observeret nogen suppression af Hib antistofniveauet, men alle børn havde beskyttende niveauer.
English: • Hypotonic-hyporesponsive episode (collapse or shock-like state)
Danish: • Hypotonisk hyporesponsiv episode (kollaps eller choklignende tilstand)
English: These reactions were primarily transient in nature.
Danish: Disse reaktioner var for det meste moderate
English: The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas (see sections 4.4, 4.8 and 5.1).
Danish: Brugen af Prevenar bør besluttes på basis af officielle anbefalinger, som tager højde for indvirkningen af invasiv sygdom hos forskellige aldersgrupper samt forskelle i serotype-epidemiologi i forskellige geografiske områder (se afsnit 4.4, 4.8 og 5.1).
English: A total of 52 cases of invasive disease caused by vaccine serotypes had accumulated in a blinded followup period through April 20, 1999.
Danish: I alt 52 tilfælde af invasiv sygdom forårsaget af vaccine serotyper var akkumuleret i en udvidet, blindet opfølgningsperiode indtil 20. april 1999.
English: Efficacy of Prevenar against AOM was assessed as a secondary endpoint in the Kaiser Permanente trial.
Danish: Prevenars effekt over for AOM blev bedømt som sekundært slutresultat i Kaiser Permanente undersøgelsen.
English: Amongst the most commonly reported adverse reactions were injection site reactions and fever.
Danish: Blandt de hyppigst rapporterede bivirkninger var reaktioner på injektionsstedet og feber.
English: Adverse reactions reported in clinical trials or from the post-marketing experience are listed in the following table per system organ class and per frequency and this is for all age groups.
Danish: Bivirkninger rapporteret ved kliniske undersøgelser eller erfaringer efter markedsføring er anført i følgende liste inddelt efter systemorganklasse og hyppighed og for alle aldersgrupper.
English: Do not use Prevenar after the expiry date stated on the carton and label.
Danish: Brug ikke Prevenar efter den udløbsdato, der står på pakningen.
English: Due to the long-standing post marketing experience, the well characterised safety profile and the large exposure of the product the PRAC recommended to amend the PSUR frequency to 10-yearly and to amend Annex II accordingly to reflect the current QRD template sentence referring to the EURD list.
Danish: På baggrund af den langvarige erfaring efter markedsføringen, den velbeskrevne sikkerhedsprofil og produktets store eksponering anbefalede PRAC at ændre den periodiske indsendelse af sikkerhedsopdateringer (PSUR) til hvert 10. år og at ændre Bilag II i overensstemmelse dermed for at afspejle den aktuelle formulering fra QRD-skabelonen, som refererer til EURD-listen.
English: It will not protect against other infectious agents that can cause
Danish: Den beskytter ikke mod andre smitstoffer, som kan
English: It is estimated that more than 80 % of the antimicrobial resistant strains would be covered by the serotypes included in the vaccine.
Danish: Det vurderes, at mere end 80% af de antimikrobielt resistente stammer vil være dækket af serotyperne i vaccinen.
English: Infants aged 6 weeks to 6 months of age
Danish: Spædbørn i alderen 6 uger til 6 måneder
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for
English: - if your child is allergic (hypersensitive) to the active substances, to any other ingredients or to
Danish: - hvis Deres barn er overfølsom (allergisk) over for de aktive stoffer eller et af de øvrige
English: Most of the data have indicated that smaller proportions of infants achieved antibody concentrations ≥0.35 μg/ml (the reference antibody concentration recommended by
Danish: De fleste data har indikeret, at et lille antal spædbørn opnåede antistofkoncentrationer ≥ 0,35 μg/ml (den af WHO anbefalede antistofkoncentration)
English: The vaccine should be well shaken to obtain a homogeneous white suspension and 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 inspiceres visuelt for eventuelle partikler og/eller forandring af fysisk udseende inden indgivelse.
English: Like all vaccines, Prevenar can cause side effects, although not everybody gets them.
Danish: Prevenar kan som alle andre vacciner give bivirkninger, men ikke alle får bivirkninger.
English: The pneumococcus is responsible for 30-40% of all bacterial AOM and a greater fraction of severe AOM.
Danish: Pneumokokker er ansvarlige for 30-40% af alle bakterielle tilfælde af AOM og en større andel af alvorlig AOM.
English: Efficacy trials in the 2- to 5-year-old population have not been conducted.
Danish: Der er ikke foretaget effektforsøg i populationen 2 til 5 år.
English: Prevenar can be administered simultaneously with other paediatric vaccines in accordance with the recommended immunisation schedules.
Danish: Prevenar kan indgives samtidigt med andre pædiatriske vacciner i overensstemmelse med de anbefalede immuniseringsplaner.
English: Children were followed until 3.5 years of age.
Danish: Børnene blev fulgt, indtil de var 3½ år gamle.
English: However, the presence of a minor infection, such as a cold, should not result
Danish: Tilstedeværelsen af en lettere infektion, såsom en forkølelse, bør dog ikke
English: - for children with seizure disorders or with a prior history of febrile seizures.
Danish: - til børn med anfaldssygdomme eller med en tidligere anamnese med febrile krampeanfald.
English: In older children receiving a single dose of vaccine, a higher rate of local reactions has been observed than that previously described in infancy.
Danish: Hos ældre børn, som fik en enkelt vaccinedosis, observeredes en større frekvens af lokale reaktioner, end hvad der tidligere er beskrevet for spædbørn.
English: The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine into your child's arm or leg muscle.
Danish: Deres læge eller sygeplejerske vil injicere den anbefalede dosis (0,5 ml) af vaccinen i en muskel på Deres barns arm eller ben.
English: Pharmacotherapeutic group: pneumococcal vaccines, ATC code: J07AL02
Danish: Farmakoterapeutisk klassifikation: Pneumokokvacciner, ATC-kode: J07AL02.
English: CRM197, Activated Saccharides, and Conjugates Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 4300 Oak Park
Danish: CRM197, aktiverede saccharider og konjugater Wyeth Pharmaceuticals, Division of Wyeth Holdings Corporation 4300 Oak Park
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 ved alle vacciner til injektion, skal relevant lægebehandling og overvågning altid være til stede i tilfælde af en sjælden anafylaktisk hændelse efter indgivelse af vaccinen.
English: * Conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg)
Danish: * Konjugeret til CRM197 bærerproteinet og adsorberet på aluminiumphosphat (0,5 mg)
English: The safety of the vaccine was assessed in different controlled clinical studies in which more than 18,000 healthy infants (6 weeks to 18 months) were included.
Danish: Vaccinens sikkerhed blev vurderet i forskellige, kontrollerede undersøgelser, hvori mere end 18.000 raske børn (i alderen 6 uger til 18 måneder) indgik.
English: After primary immunisation, 95.6% of the subjects had antibody levels of at least 0.35 µg/ml for all seven serotypes found in Prevenar.
Danish: Efter den primære immunisering havde 95,6% af børnene antistofniveauer på mindst 0,35 µg/ml for alle syv serotyper fra Prevenar.
English: The expiry date refers to the last
Danish: Udløbsdatoen (Exp) er den sidste dag
English: The immunogenicity of Prevenar has been investigated in an open-label, multicenter study in 49 infants with sickle cell disease.
Danish: Prevenars immunogenicitet er blevet undersøgt i en åben multicenter undersøgelse med 49 børn med seglcellesygdom.
English: Estimates of efficacy against invasive disease were obtained in the US population where vaccine serotype coverage ranged from 80 to 89 %.
Danish: Bedømmelsen af effekten over for invasiv sygdom kommer fra den amerikanske befolkning, hvor vaccine serotype dækningen varierer mellem 80 til 89%.
English: Although some antibody response to diphtheria toxoid may occur, immunisation with this vaccine does not substitute for routine diphtheria immunisation.
Danish: Selvom der kan forekomme nogle antistofreaktioner over for difteritoxin, er immunisering med denne vaccine ikke en erstatning for rutinemæssig immunisering for difteri.
English: At the time of the study, the serotypes included in the vaccine accounted for 89 % of IPD.
Danish: På undersøgelsestidspunktet dækkede de serotyper, der er i vaccinen, for 89% af IPD.
English: No undesirable effects were reported in the majority of individuals.
Danish: For de fleste personer blev der ikke rapporteret om bivirkninger.
English: Efficacy against invasive disease was assessed in a large-scale randomised, double-blind, clinical trial in a multiethnic population in Northern California (Kaiser Permanente trial).
Danish: Effekt mod invasiv sygdom blev vurderet i en storstilet klinisk randomiseret dobbeltblind undersøgelse i en multietnisk befolkning i det nordlige Californien (Kaiser Permanente undersøgelse).
English: Apnoea in very premature infants ( 28 weeks of gestation) (see section 4.4).
Danish: Apnø hos præmature ( 28 ugers svangerskab) (se afsnit 4.4).
English: In general, adverse reactions reported with overdose have also been reported with recommended single doses of Prevenar.
Danish: Generelt er bivirkningsrapporter med overdosering også rapporteret for anbefalede Prevenar enkeltdoser.
English: Vaccination in high-risk groups should be considered on an individual basis.
Danish: Vaccination i højrisikogrupper bør overvejes i det enkelte tilfælde.
English: Redness was reported in 40.0 % of children, and induration was reported in 32.2 % of subjects.
Danish: Rødme blev set hos 40,0% af børnene, og induration blev rapporteret hos 32,2% af børnene.
English: Consequently, Prevenar should cover between 54 % and 84 % of isolates from invasive pneumococcal disease (IPD) in European children less than 2 years of age.
Danish: Som følge heraf skulle Prevenar dække mellem 54 og 84% af isolater fra invasive pneumokoksygdomme (IPD) hos europæiske børn under 2 år.
English: Inconsistent reduction in response to pertussis antigens as well as to inactivated polio vaccine (IPV) were observed.
Danish: Der blev observeret inkonsistent reduktion i responsen på pertussis antigener og på inaktiveret poliovaccine (IPV).
English: Additionally, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease.
Danish: For vaccine-serotyperne forventes beskyttelsen mod otitis media derudover at være væsentlig lavere end beskyttelsen mod invasiv sygdom.
English: Also contains sodium chloride and water for injections.
Danish: Indeholder også natriumchlorid og vand til injektion.
English: Prevenar will only protect against ear infections caused by the types of Streptococcus pneumoniae for which the vaccine has been developed.
Danish: Prevenar beskytter kun mod infektioner i øret, som er forårsaget af de typer Streptococcus pneumoniae, som vaccinen er udviklet til.
English: Children below 2 years old should receive the appropriate-for-age Prevenar vaccination series (see section 4.2).
Danish: Børn under 2 år bør have den for alderen passende Prevenar vaccinationsserie (se afsnit 4.2).
English: The preferred sites are anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in young children.
Danish: De foretrukne steder er den anterolaterale side af låret (musculus vastus lateralis) hos spædbørn, eller i musculus deltoideus på overarmen hos små børn.