FrancophonIA/ELRC3.0 huggingface dataset:
English: In the first study, the immunogenicity of Pumarix was shown to be comparable to that of the comparator vaccine.
Danish: Den første undersøgelse viste, at Pumarix' immunogenicitet svarer til sammenligninsvaccinens.
English: During a pandemic, the virus strain in the vaccine will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Danish: Under en pandemi skal virusstammen i vaccinen erstattes med den stamme, der forårsager pandemien, inden vaccinen kan
English: The vaccine contains a flu strain called ‘A/Indonesia/05/2005 PR8-IBCDCRG2' (H5N1).
Danish: Vaccinen indeholder en influenzavirusstamme kaldet ”A/Indonesia/05/2005 PR8
English: Pumarix is a ‘mock-up' vaccine.
Danish: Pumarix er en ”modelvaccine”.
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Danish: Når en person vaccineres, opfatter immunsystemet virusset som ”fremmed” og producerer antistoffer mod det. Immunsystemet kan således hurtigere danne antistoffer, når det udsættes for samme virus igen.
English: How does Pumarix work?
Danish: Hvordan virker Pumarix?
English: The main measure of effectiveness in both studies was the ability to trigger the production of antibodies against the flu virus (‘immunogenicity') after six weeks.
Danish: I begge undersøgelser blev virkningen hovedsagelig målt på evnen til at udløse dannelsen af antistoffer mod influenzavirusset
English: This means that, because the vaccine is a mock up and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine.
Danish: Det betyder, at det ikke har været muligt at opnå fyldestgørende oplysninger om den endelige pandemiske vaccine, da det er en modelvaccine, som endnu ikke indeholder den influenzavirusstamme, der forårsager en pandemi.
English: What benefit has Pumarix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Pumarix?
English: The vaccine can only be obtained with a prescription.
Danish: Vaccinen kan derfor ikke fremstilles på forhånd.
English: Adopted at the 2-5 September 2019 PRAC
Danish: Vedtaget på PRAC's møde den 2.-5. september 2019
English: Not known (frequency cannot be estimated from the available data)
Danish: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: Frequency “Not known”
Danish: Hyppighed ikke kendt
English: Stop using <product name> if you develop these symptoms and seek medical attention immediately.
Danish: Hold op med at bruge <produktnavn>, hvis du udvikler disse symptomer, og søg læge med det samme.
English: In both cases, tTreatment with <product name> may be restarted once when the ketone values are normal and the patient's condition has stabilised.
Danish: I begge tilfælde kan bBehandlingen med <produktnavn> kan genoptages, når førstnår ketonstofværdierne er normale, og patientens tilstand er stabiliseret.
English: Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment.
Danish: Patienterne har formentlig højere risiko for at få disse reaktioner tidligt i behandlingsforløbet, idet reaktionen i de fleste tilfælde opstår inden for den første måned af behandlingen.
English: Footnotes:
Danish: Fodnoter:
English: What you need to know before you use <product name>
Danish: Det skal du vide, før du begynder at tage <produktnavn>
English: 2 The following text should replace any current information regarding serious skin reactions in section Warnings and precautions.
Danish: 2 Følgende tekst bør erstatte alle nuværende oplysninger om hudreaktioner i afsnittet Advarsler og forsigtighedsregler.
English: Serious skin reactions have been reported in association with <product name> treatment.
Danish: Der er rapporteret om alvorlige hudreaktioner ved behandling med <produktnavn>.
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors2New information on the known association between SGLT2 inhibitors and diabetic ketoacidosis in surgical patients (EPITT no 19355)
Danish: Natriumglukose-co-transportør 2 (SGLT2)-hæmmere2nye oplysninger om den kendte forbindelse mellem SGLT2hæmmere og diabetisk ketoacidose hos kirurgiske patienter (EPITT nr. 19355)
English: Latency from the initiation of treatment with ibrutinib to the onset of ischemic central nervous vascular conditions was in the most cases after several months (more than 1 month in 78% and more than 6 months in 44% of cases) emphasizing the need for regular monitoring of patients (please see section 4.4 Cardiac arrhythmia and Hypertension and section 4.8).
Danish: Latenstiden fra påbegyndelse af behandling med ibrutinib til forekomst af iskæmiske vaskulære tilstande i centralnervesystemet var i de fleste tilfælde flere måneder (over 1 måned i 78 % af tilfældene og over 6 måneder i 44 % af tilfældene), hvilket understreger behovet for regelmæssig overvågning af patienterne (se pkt.
English: Warnings and precautions - Take special care with <product name> Skin reactions2
Danish: Advarsler og forsigtighedsregler - Vær ekstra forsigtig med <produktnavn> Hudreaktioner2
English: Tell a doctor straight away if you notice any of the following side effects: Uncommon (may affect up to 1 in 100 people): temporary episode of neurologic dysfunction caused by loss of blood flow, stroke.
Danish: Fortæl det straks til lægen, hvis du oplever en eller flere af følgende bivirkninger: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter): Forbigående episode med neurologisk dysfunktion forårsaget af tab af blodgennemstrømning, slagtilfælde.
English: Treatment withdrawal and initiation of an accelerated elimination procedure may be considered taking into account patient's disease and medical history.
Danish: Seponering af behandlingen og iværksættelse af en accelereret eliminationsprocedure kan overvejes, idet der skal tages hensyn til patientens sygdom oganamnese.
English: You should stop taking <product name> and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction.
Danish: Du bør stoppe med at tage <produktnavn> og straks søge læge, hvis du får hududslæt, læsioner i slimhinderne, blærer eller andre tegn på allergi, da dette kan være de første tegn på en meget alvorlig hudreaktion.
English: Teriflunomide - Psoriasis (EPITT no 19366)
Danish: Teriflunomid - psoriasis (EPITT nr. 19366)
English: Special warnings and precautions for use Diabetic ketoacidosis
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Diabetisk ketoacidose
English: A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
Danish: Et stort, rødt og skællende udslæt med knuder under huden og blæredannelse, primært i hudfolder, på kroppen og på armene og ledsaget af feber i begyndelsen af behandlingen (akut generaliseret eksantematøs pustulose).
English: Severe skin reactions
Danish: Svære hudreaktioner
English: For ibuprofen and pseudoephedrine combinations 4.4.
Danish: For kombinationsbehandling med ibuprofen og pseudoephedrin 4.4.
English: Ibuprofen - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 19409)
Danish: Ibuprofen - akut generaliseret eksantematøs pustulose (AGEP) (EPITT nr. 19409)
English: New onset of psoriasis (including pustular psoriasis) and worsening of pre-existing psoriasis have been reported during the use of teriflunomide.
Danish: Der er rapporteret om ny forekomst af psoriasis (herunder pustuløs psoriasis) og forværring af eksisterende psoriasis ved behandling med teriflunomid.
English: Ibuprofen should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.
Danish: Ibuprofen bør seponeres ved de første tegn og symptomer på svære hudreaktioner, f.eks. hududslæt, læsioner i slimhinderne eller andre tegn på overfølsomhed.
English: For ibuprofen monotherapy or ibuprofen in combinations excluding combinations with pseudoephedrine
Danish: For ibuprofen som enkeltstofbehandling eller ibuprofen i kombinationsbehandling, bortset fra kombinationer med pseudoephedrin
English: Tabulated list of adverse reactions Skin and subcutaneous tissue disorders Frequency not known: Psoriasis (including pustular psoriasis)b b: see section 4.4
Danish: Hud og subkutane væv Hyppighed ikke kendt: Psoriasis (herunder pustuløs psoriasis)b b: Se pkt.
English: Ibrutinib - Ischaemic stroke (EPITT no 19369)
Danish: Ibrutinib - iskæmisk slagtilfælde (EPITT nr. 19369)
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDSs (see section 4.8).
Danish: Der er rapporteret om sjældne tilfælde af alvorlige hudreaktioner, indimellem med dødelig udgang, herunder eksfoliativ dermatitis, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse, ved anvendelse af NSAIDS'er (se pkt.
English: Uncommon: cerebrovascular accident, transient ischaemic attack, ischaemic stroke
Danish: Ikke almindelige bivirkninger: cerebrovaskulær hændelse, transitorisk iskæmisk attak, iskæmisk slagtilfælde
English: Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products.
Danish: Der er rapporteret om akut generaliseret eksantematøs pustulose (AGEP) i forbindelse med ibuprofen-holdige lægemidler.
English: 1 Only if the already existing AGEP ADR in section 4.8 is listed specifically for pseudoephedrine.
Danish: 4.8 er angivet specifikt for pseudoephedrin.
English: Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with ibuprofen and pseudoephedrine-containing products.
Danish: Der kan opstå svære hudreaktioner, f.eks. akut generaliseret eksantematøs pustulose (AGEP), ved anvendelse af ibuprofen i kombination med pseudoephedrin-holdige lægemidler.
English: Special warnings and precautions for use Severe skin reactions
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Svære hudreaktioner
English: Special warnings and precautions for use Skin reactions
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Hudreaktioner
English: The children were followed up until the end of their second year of life.
Danish: Der blev fulgt op på børnene indtil udgangen af deres andet leveår.
English: The full EPAR for Synflorix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Synflorix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Synflorix on 30 March 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Synflorix den 30. marts 2009.
English: The children were followed up for an average of around 2 years.
Danish: Børnene blev fulgt i gennemsnitligt 2 år.
English: The majority of these reactions were of mild to moderate severity and were not long lasting.
Danish: De fleste bivirkninger var milde til moderate og var ikke langvarige.
English: This is a summary of the European public assessment report (EPAR) for Synflorix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Synflorix.
English: The vaccination schedule for Synflorix depends on the age of the child and should be based on official recommendations.
Danish: Vaccinationsprogrammet for Synflorix afhænger af barnets alder og bør være baseret på officielle anbefalinger.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend the body against the infection.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare kroppen mod infektionen.
English: In Europe, it is estimated that these are responsible for 56 to 90% of the cases of invasive disease caused by S. pneumoniae in children under the age of 5 years.
Danish: I Europa anslås det, at disse er ansvarlige for mellem 56 og 90 % af alle tilfælde af invasiv sygdom forårsaget af S. pneumoniae hos børn under 5 år.
English: Additional studies looked at the effects of booster vaccinations and vaccinations in older infants and children.
Danish: Andre undersøgelser havde til formål at vurdere virkningen af boostervaccination og vaccination af ældre spædbørn og børn.
English: The children received one dose of Synflorix in the first study and two doses in the second study.
Danish: Børnene modtog én dosis Synflorix i den første undersøgelse og to doser i den anden undersøgelse.
English: For the three additional polysaccharides (1, 5, 7F), Synflorix was effective in triggering the production of antibodies.
Danish: For de tre sidste polysakkarider (1, 5 og 7F) var Synflorix effektivt til at udløse dannelse af antistoffer.
English: Synflorix contains the polysaccharides from ten different types of S. pneumoniae (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).
Danish: Synflorix indeholder polysakkarider fra 10 forskellige typer S. pneumoniae (serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F og 23F).
English: The vaccine is given by injection into the thigh muscle in infants or into the shoulder muscle in young children.
Danish: Vaccinen gives ved indsprøjtning i lårmusklen hos spædbørn eller i skuldermusklen hos mindre børn.
English: The most common side effects with Synflorix (which may affect more than 1 in 10 people) are pain, redness and swelling at the injection site, fever, drowsiness, irritability and loss of appetite.
Danish: De hyppigste bivirkninger ved Synflorix (som kan forekomme hos mere end 1 ud af 10 patienter) er smerte, rødme og hævelse på injektionsstedet, feber, sløvhed, irritabilitet og appetitløshed.
English: However, children aged under 6 months with conditions that make them more likely to catch these invasive diseases, such as those with human immunodeficiency virus (HIV) infection, sickle cell disease or spleen problems, should be given three doses followed by a booster dose.
Danish: Børn under 6 måneder med tilstande, der gør dem mere modtagelige over for disse invasive sygdomme, som f.eks. børn, der har hiv (humant immundefektvirus)-infektion, seglcelleanæmi eller miltproblemer, bør have tre doser efterfulgt af en booster.
English: What measures are being taken to ensure the safe and effective use of Synflorix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Synflorix?
English: Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Danish: Konjugeret polysakkarid-pneumokokvaccine (adsorberet)
English: The ability of Synflorix to trigger the production of antibodies (immunogenicity) was assessed in one main study involving 1,650 healthy infants aged between 6 and 12 weeks.
Danish: Synflorix' evne til at udløse dannelse af antistoffer (immunogenicitet) blev vurderet i en hovedundersøgelse, der omfattede 1.650 raske spædbørn i alderen 6-12 uger.
English: Other information about Synflorix
Danish: Andre oplysninger om Synflorix
English: The response to Synflorix in 2 to 5 year olds was similar to the younger age group, with better results in children who received two doses.
Danish: Responset på Synflorix hos børn i alderen 2-5 år svarede til responset i den yngre aldersgruppe, med bedre resultater hos børn, der fik to doser.
English: The studies showed that Synflorix led to an increase in antibody production following booster vaccinations.
Danish: Undersøgelserne viste, at Synflorix medførte en stigning i dannelsen af antistoffer efter boostervaccinationer.
English: Synflorix is available as a suspension for injection.
Danish: Synflorix fås som en suspension til injektion.
English: For more information about treatment with Synflorix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Synflorix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Synflorix contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule' that surrounds the S. pneumoniae bacterium.
Danish: Synflorix indeholder små mængder polysakkarider (en type sukker), der udvindes af den "kapsel", som omgiver bakterien S. pneumoniae.
English: The percentage of children who had bacterial pneumonia was 2.3% (240 out of over 10,000) among those given Synflorix compared with 3% (304 out of over 10,000) among those given the comparator.
Danish: Andelen af børn med bakteriel lungebetændelse var 2,3 % (240 ud af over 10.000) blandt de børn, der fik Synflorix, sammenholdt med 3 % (304 ud af over 10.000) blandt de børn, der fik sammenligningsvaccinen.
English: These polysaccharides have been purified, then conjugated (attached) to a carrier to help them to be recognised by the immune system.
Danish: Polysakkariderne er blevet renset og derefter fastgjort (konjugeret) til en bærer, for at immunsystemet bedre kan genkende dem.
English: A fourth (‘booster') dose is recommended at least 6 months after the third dose, preferably when the child is between 12 and 15 months of age.
Danish: En fjerde dosis (en "booster"-dosis) anbefales mindst seks måneder efter den tredje dosis, helst når barnet er 12-15 måneder gammelt.
English: In particular, two clinical studies in children aged 2 to 5 years investigated the ability of Synflorix to produce antibodies in this age group compared with other age groups.
Danish: Navnlig blev der gennemført to kliniske undersøgelser af børn i alderen 2-5 år, hvor man vurderede Synflorix' evne til at danne antistoffer hos denne aldersgruppe sammenholdt med andre aldersgrupper.
English: Invasive disease results from the bacterium spreading through the body causing serious infections such as septicaemia (blood infection), meningitis (infection of the membranes around the brain and spine) and pneumonia.
Danish: Invasiv sygdom optræder, når bakterien spreder sig i kroppen og forårsager alvorlige infektioner som f.eks. blodforgiftning, meningitis (betændelse i hinderne rundt om hjernen og rygmarven) og lungebetændelse.
English: In studies in infants and older children, although Synflorix produced a lower antibody response than the comparator vaccine, it fulfilled pre-defined criteria and was considered acceptable in this group.
Danish: Undersøgelser hos spædbørn og ældre børn viste, at selvom Synflorix gav et lavere antistofrespons end sammenligningsvaccinen, levede det op til de foruddefinerede kriterier og blev betragtet som acceptabelt i denne gruppe.
English: Synflorix was as effective as the comparator in triggering the production of antibodies against five of the polysaccharides that the two vaccines shared in common (4, 9V, 14, 18C and 19F), but it was less effective than the comparator for two (6B and 23F).
Danish: Synflorix var lige så effektivt som sammenligningsvaccinen til at udløse dannelse af antistoffer mod fem af de polysakkarider, som de to vacciner havde tilfælles (4, 9V, 14, 18C og 19F), men det var mindre effektivt end sammenligningsvaccinen for to af dem (6B og 23F).
English: • When Synflorix is given as part of a routine infant immunisation programme (when all infants in an area are vaccinated at around the same time), a course of two doses may be given 2 months apart, from the age of 6 weeks, followed by a booster dose at least 6 months later.
Danish: • Når Synflorix gives inden for et almindeligt immuniseringsprogram for spædbørn (når alle spædbørn i et område vaccineres omtrent samtidig), kan et vaccinationsforløb på to doser gives med to måneders mellemrum, fra spædbørnene er 6 uger gamle, efterfulgt af en booster mindst seks måneder senere.
English: The vaccine is also adsorbed (fixed) onto an aluminium compound to stimulate a better response.
Danish: Vaccinen bliver desuden bundet til overfladen (adsorberet) af en aluminiumholdig forbindelse for at forstærke immunresponset.
English: It is recommended that a booster dose be given at least 6 months after the third dose.
Danish: Det anbefales, at der gives en booster mindst seks måneder efter den tredje dosis.
English: It is not intended to provide practical advice on how to use Synflorix.
Danish: Det er ikke en praktisk vejledning i, hvordan Synflorix bør anvendes.
English: The Agency also noted that Synflorix contains additional polysaccharides from the types of S. pneumoniae that are responsible for disease in Europe and therefore decided that Synflorix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturet lagde også vægt på, at Synflorix indeholder yderligere polysakkarider fra de typer S. pneumoniae, der er ansvarlige for sygdom i Europa, og vurderede derfor, at fordelene ved Synflorix opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Synflorix.
English: What is Synflorix and what is it used for?
Danish: Hvad er Synflorix, og hvad anvendes det til?
English: Synflorix is a vaccine that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae, also called pneumococcus).
Danish: Synflorix er en vaccine, der indeholder dele af bakterien Streptococcus pneumoniae (S. pneumoniae, også kaldet pneumokok).
English: Why is Synflorix approved?
Danish: Hvorfor blev Synflorix godkendt?
English: Synflorix is a vaccine that protects against infections caused by S. pneumoniae.
Danish: Synflorix er en vaccine, der beskytter mod infektioner forårsaget af S. pneumoniae.
English: It is recommended that a booster dose is given at least 2 months after the second dose, during the child's second year of life.
Danish: Det anbefales, at der gives en booster mindst to måneder efter den anden dosis i løbet af barnets andet leveår.
English: The occurrence of the first episode of acute otitis media caused by S. pneumoniae was approximately halved among children who were given the investigational vaccine compared with those given the comparator.
Danish: Forekomsten af den første episode af akut mellemørebetændelse forårsaget af S. pneumoniae var omtrent halveret hos de børn, der havde fået forsøgsvaccinen, sammenholdt med de børn, der havde fået sammenligningsvaccinen.
English: Synflorix must not be used in children who have a high fever, but it can be given in children who have a mild infection such as a cold. For the full list of restrictions, see the package leaflet.
Danish: Synflorix må ikke anvendes hos børn med høj feber, men kan anvendes hos børn, der har en mild infektion som f.eks. en forkølelse.
English: The study involved almost 5,000 infants aged 3 months and compared an investigational vaccine that contains the same polysaccharides as Synflorix with another vaccine that is not active against S. pneumoniae (in this case, a vaccine against hepatitis A virus).
Danish: Undersøgelsen omfattede næsten 5.000 spædbørn i alderen 3 måneder og sammenlignede en forsøgsvaccine, der indeholdt de samme polysakkarider som Synflorix, med en anden vaccine, som ikke virkede på S. pneumoniae (i dette tilfælde en vaccine mod hepatitis A-virus).
English: For practical information about using Synflorix, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Synflorix, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The children in this study were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae and were followed up for an average of 30 months.
Danish: Børnene i denne undersøgelse fik enten Synflorix eller en sammenligningsvaccine, som ikke virkede på S. pneumoniae, og der blev fulgt op på børnene i gennemsnitligt 30 måneder.