FrancophonIA/ELRC3.0 huggingface dataset:
English: In Europe, it is estimated that these are responsible for about 54% to 84% of invasive infections (infections that have spread into the body) in infants and children under the age of two years, and for about 62% to 83% of invasive infections in children aged between two and five
Danish: I Europa skønnes disse serotyper at være årsag til ca. 54-84 % af alle invasive infektioner (infektioner, der har spredt sig i kroppen) hos spædbørn og børn under to år, og til ca. 6283 % af alle invasive infektioner hos børn mellem to og fem år.
English: Pneumococcal saccharide conjugated vaccine, adsorbed
Danish: Konjugeret saccharid pneumokokvaccine, adsorberet
English: Half of the infants received Prevenar, and the remainder received another vaccine that is not active against S. pneumoniae.
Danish: Den ene halvdel af børnene fik Prevenar, og den anden fik en anden vaccine, der ikke er aktiv mod S. pneumoniae.
English: Prevenar is used to vaccinate infants and children aged between two months and five years against diseases caused by S. pneumoniae.
Danish: Prevenar anvendes til vaccination af spædbørn og børn fra to måneder til fem år mod sygdomme forårsaget af S. pneumoniae.
English: When a person is given the vaccine, the immune system recognises the bacterium contained in the vaccine as ‘foreign' and makes antibodies against it.
Danish: Når man bliver vaccineret, opfatter immunsystemet bakterien i vaccinen som "fremmed" og danner antistoffer mod den.
English: Additional studies looked at the effectiveness and safety of Prevenar in older infants and children, and at the development of antibodies in infants after the two-dose immunisation schedule followed by a
Danish: Yderligere undersøgelser så på virkningen og sikkerheden af Prevenar hos småbørn og børn og på dannelsen af antistoffer hos spædbørn efter to-dosis immuniseringsprogrammet efterfulgt af en
English: Prevenar should not be used in children who may be hypersensitive (allergic) to the Streptococcus vaccine, to any of the other ingredients or to the diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).
Danish: Prevenar bør ikke anvendes til børn, der kan være overfølsomme (allergiske) over for streptokokvaccinen, over for andre af indholdsstofferne eller over for difteritoksoidet (et svækket toksin fra bakterien, der forårsager difteri).
English: What benefit has Prevenar shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Prevenar?
English: Prevenar contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule' that surrounds the S. pneumoniae bacterium.
Danish: Prevenar indeholder små mængder polysakkarider (en slags sukker), der udvindes af den kapsel, der omgiver bakterien S. pneumoniae.
English: Vaccination should be postponed in children with a severe infection
Danish: Vaccination bør udsættes hos børn med svær infektion og høj feber.
English: The effectiveness of Prevenar in the prevention of S. pneumoniae invasive disease has been studied in almost 38,000 infants.
Danish: Virkningen af Prevenar til forebyggelse af invasiv sygdom forårsaget af S. pneumoniae blev undersøgt hos næsten 38 000 børn.
English: It is a suspension for injection that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae).
Danish: Det er en injektionsvæske, suspension, der indeholder dele af bakterien Streptococcus pneumoniae (S. pneumoniae).
English: These polysaccharides have been purified, then ‘conjugated' (attached) to a carrier to help them be better recognised by the immune system.
Danish: Polysakkariderne bliver renset og derefter "konjugeret" (fastgjort) til en bærer, for at immunsystemet bedre kan genkende dem.
English: Prevenar was effective in preventing S. pneumoniae invasive disease.
Danish: Prevenar var effektivt til at forebygge invasiv sygdom forårsaget af S. pneumoniae.
English: During the main study, 49 cases of infection due to the serotypes 4, 6B, 9V, 14, 18C, 19F and 23F of S. pneumoniae were seen among the infants who received the control vaccine, compared with three cases among the infants vaccinated with Prevenar.
Danish: I hovedundersøgelsen blev der registreret 49 tilfælde af infektioner forårsaget af S. pneumoniae serotype 4, 6B, 9V, 14, 18C, 19F og 23F hos de mindre børn, der fik kontrolvaccine.
English: The first dose is usually given at two months of age with an interval of at least one month between doses.
Danish: Den første dosis gives sædvanligvis, når barnet er to måneder, og der skal gå mindst én måned mellem hver dosis.
English: The vaccine is given by injection into the thigh muscle in infants, or into the upper arm muscle in
Danish: Vaccinen gives ved indsprøjtning i lårmusklen hos spædbørn eller i overarmsmusklen hos mindre børn.
English: The vaccine is also ‘adsorbed' (fixed) onto an aluminium compound to stimulate a better response.
Danish: Vaccinen bliver desuden adsorberet (bundet til overfladen) af en aluminiumholdig forbindelse, hvorved immunreaktionen forstærkes.
English: These include sepsis (blood infection), meningitis (infection of the membranes that surround the brain and spine), pneumonia (infection of the lungs), otitis media (infection of the middle ear) and bacteraemia (bacteria detected in the blood).
Danish: Disse omfatter sepsis (blodforgiftning), meningitis (infektion af membranerne omkring hjernen og rygmarven), lungebetændelse, mellemørebetændelse og
English: However, the CHMP concluded that this is unlikely to lead to a difference in the rate of protection against infection with S. pneumoniae following a booster injection, when Prevenar is used as part of a routine immunisation programme in which most infants are vaccinated.
Danish: S. pneumoniae efter en boosterinjektion, når Prevenar anvendes som del af et rutinemæssigt immuniseringsprogram, hvor de fleste spædbørn vaccineres.
English: The study measured the number of children who developed an S. pneumoniae invasive disease during the 3.5 years of the study.
Danish: Det blev registreret, hvor mange af børnene der fik en invasiv sygdom forårsaget af S. pneumoniae i de tre et halvt år, undersøgelsen varede.
English: • Children aged between 24 months and five years need one single dose.
Danish: • Børn i alderen 24 måneder til 5 år skal have en enkelt dosis.
English: This helps to
Danish: Derved er man bedre beskyttet mod
English: • Infants aged between two and six months need three doses.
Danish: • Spædbørn fra to til seks måneder skal have tre doser.
English: S. pneumoniae, but to a lower level than the three-dose schedule.
Danish: Hos spædbørn bevirkede to-dosis immuniseringsprogrammet dannelse af antistoffer mod S. pneumoniae, men niveauet var lavere end i tre-dosis programmet.
English: • Children aged between 12 and 23 months need two doses, with an interval of at least two months between doses.
Danish: • Børn i alderen 12 til 23 måneder skal have to doser.
English: • Infants aged between seven and 11 months need two doses, with an interval of at least one month between doses.
Danish: • Spædbørn fra syv til 11 måneder skal have to doser.
English: This summary was last updated in November 2017.
Danish: Dette sammendrag blev sidst ajourført i november 2017.
English: Hands should be washed after handling the medicine.
Danish: Der bør vaskes hænder efter håndteringen af lægemidlet.
English: It is given to dogs once daily on an empty stomach at least one hour before the next meal.
Danish: Det gives til hunde én gang dagligt på tom mave mindst én time før det næste måltid.
English: Galliprant is a veterinary medicine.
Danish: Galliprant er et veterinærlægemiddel.
English: The European Commission granted a marketing authorisation valid throughout the EU for Galliprant on 9 January 2018.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Galliprant den 09/01/2018.
English: This is a summary of the European public assessment report (EPAR) for Galliprant.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Galliprant.
English: The full EPAR for Galliprant can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Galliprant findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The dose is based on the bodyweight of the dog and the length of treatment depends on the response.
Danish: Dosen afhænger af hundens vægt, og varigheden af behandlingen afhænger af responsen.
English: If the medicine is accidentally swallowed by a person, the advice of a doctor should be sought immediately.
Danish: Hvis en person utilsigtet indtager lægemidlet, bør der straks søges lægehjælp.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Galliprant's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Galliprant opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It is not intended to provide practical advice on how to use Galliprant.
Danish: Det er ikke en praktisk vejledning i, hvordan Galliprant bør anvendes.
English: What is Galliprant and what is it used for?
Danish: Hvad er Galliprant, og hvad anvendes det til?
English: Intermittent treatment may be beneficial in some dogs as signs of osteoarthritis come and go.
Danish: Intermitterende behandling kan være gavnlig hos nogle hunde, da tegn på osteoartritis kommer og går.
English: Galliprant is available as tablets and can only be obtained with a prescription.
Danish: Galliprant fås som tabletter og udleveres kun efter recept.
English: In total, 51% of dogs (120 of 235) were treated successfully with Galliprant at 28 days after the start of the treatment.
Danish: I alt var behandlingen med Galliprant vellykket hos 51 % (120 ud af 235) af hundene 28 dage efter påbegyndelse af behandling.
English: Galliprant contains grapiprant, a non-steroidal, non-cyclooxygenase inhibiting anti-inflammatory drug (NSAID), of the piprant class, that works in a different way from other NSAIDs, which block a range of cyclo-oxygenase enzymes.
Danish: Galliprant indeholder grapiprant, der er et non-steroidt, non-cyclooxygenase-hæmmende antiinflammatorisk lægemiddel (NSAID), der hører til piprant-klassen, og som virker på en anderledes måde end andre NSAID'er, der blokerer en række cyclooxygenase-enzymer.
English: The most common side effect with Galliprant (which may affect more than 1 in 10 animals) is mild and generally short-lived vomiting.
Danish: Den hyppigste bivirkning ved Galliprant (som kan forekomme hos mere end 1 ud af 10 hunde) er mild opkastning, der som regel er kortvarig.
English: It contains the active substance grapiprant.
Danish: Det indeholder det aktive stof grapiprant.
English: Why is Galliprant approved?
Danish: Hvorfor blev Galliprant godkendt?
English: By blocking EP4, grapiprant helps relieve the signs of the condition.
Danish: Ved at blokere EP4 medvirker grapiprant til at lindre tegnene på
English: Galliprant must not be given to pregnant, lactating or breeding dogs.
Danish: Galliprant må ikke gives til drægtige eller diegivende hunde eller avlshunde.
English: What are the risks associated with Galliprant?
Danish: Hvilke risici er der forbundet med Galliprant?
English: Success was assessed by the dog owners and by veterinarians, using scoring systems for pain severity, pain interference and overall life quality.
Danish: Behandlingsresultatet blev bedømt af hundeejerne og dyrlæger ved hjælp af scoresystemerne til vurdering af sværhedsgraden af smerterne, smerteinterferens og overordnet livskvalitet.
English: For the full list of side effects and restrictions with Galliprant, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Galliprant fremgår af indlægssedlen.
English: Grapiprant works by blocking a specific target receptor called EP4, through which natural substances called prostaglandins act to produce pain in osteoarthritis.
Danish: Grapiprant virker ved at blokere en specifik målreceptor (EP4), hvorigennem naturlige stoffer, der kaldes prostaglandiner, virker ved at fremkalde smerte.
English: If swallowed by a child, mild and reversible gastrointestinal signs and nausea may be seen.
Danish: Hvis et barn indtager det, kan det medføre milde og reversible gastrointestinale tegn, og kvalme kan forekomme.
English: Two field studies were conducted involving dogs mostly with mild to moderate osteoarthritis confirmed by radiography in at least one limb joint.
Danish: Der er gennemført to feltundersøgelser med hunde, der havde mild til moderat osteoartritis som bekræftet ved radiografi i mindst ét led i et ben.
English: Other information about Galliprant?
Danish: Andre oplysninger om Galliprant
English: This compared to 36% of dogs receiving a dummy treatment (82 of 231).
Danish: Blandt de hunde, der fik ikkeaktivt stof, var behandlingen vellykket hos 36 % (82 ud af 231).
English: It is used in dogs to treat pain associated with mild to moderate osteoarthritis, a condition causing swelling and pain in the joints.
Danish: Det anvendes til hunde, der har smerter som følge af mild til moderat osteoartritis (en lidelse, som medfører hævelse og smerter i leddene).
English: How is Galliprant used?
Danish: Hvordan anvendes Galliprant?
English: What benefits of Galliprant have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Galliprant?
English: For more information about treatment with Galliprant, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Galliprant, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How does Galliprant work?
Danish: Hvordan virker Galliprant?
English: For practical information about using Galliprant, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Galliprant, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Strength Pharmaceutical Form Route of Administration
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage Indhold
English: Always wash your hands and ensure that the area around you is clean.
Danish: Vask altid dine hænder, og sørg for at området omkring dig er rent.
English: • Inject slowly over 1 to 3 minutes.
Danish: • Injicér langsomt over 1 til 3 minutter.
English: General recommendations are provided in Table 2.
Danish: Generelle anbefalinger findes i tabel 2.
English: Additional doses can be given if needed.
Danish: Der kan om nødvendigt gives yderligere doser.
English: This may become severe and could be life-threatening
Danish: Disse kan blive alvorlige og være livstruende
English: All evaluated minor surgeries were performed successfully.
Danish: Alle evaluerede mindre kirurgiske indgreb var udført med succes.
English: A single dose is recommended.
Danish: En enkelt dosis anbefales.
English: • you have recently had surgery
Danish: • du er blevet opereret for nylig
English: CV = coefficient of variation.
Danish: CV = variationskoefficient.
English: • Take out the number of Refixia packages you need.
Danish: • Tag det antal pakninger med Refixia, du har brug for.
English: Pack size of 1.
Danish: Pakningsstørrelse med 1.
English: This is given as one injection every week.
Danish: Dosis gives som én injektion hver uge.
English: • Check the name, strength and colour of the package, to make sure it contains the correct product.
Danish: • Kontrollér navnet, styrken og farven på pakningen for at sikre, at den indeholder det rigtige præparat.
English: Eighteen out of these 20 joints (90%) were no longer considered target joints at the end of the trial.
Danish: 18 ud af disse 20 led (90%) blev ikke længere betragtet som target joints ved studiets afslutning.
English: Always use an aseptic technique.
Danish: Benyt altid aseptisk teknik.
English: Osmolality: 272 mOsmol/kg.
Danish: Osmolalitet: 272 mOsmol/kg.
English: Pre-operative dose.
Danish: Præoperativ dosis.
English: In each of these situations, the benefit of treatment with Refixia should be weighed against the risk of these complications.
Danish: I alle disse situationer skal fordelen ved behandling med Refixia vejes op imod risikoen for disse komplikationer.
English: From a microbiological point of view, the reconstituted product should be used immediately.
Danish: Fra en mikrobiologisk synsvinkel skal det rekonstituerede præpararet anvendes straks.
English: If the medicine has not been used before the new expiry date, it should be disposed of.
Danish: Hvis lægemidlet ikke er blevet anvendt inden den nye udløbsdato, skal det kasseres.
English: In case of self-administration or administration by caregiver appropriate training is needed.
Danish: I tilfælde af selvadministration eller administration, der foretages af en omsorgsperson, er passende oplæring nødvendig.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Nedenstående tabel er opstillet i henhold til MedDRA-systemorganklassifikationen (SOC og Preferred Term Level).
English: Submission of study results: Q2-2028
Danish: Fremsendelse af studieresultaler: Q2-2028
English: Do not use the powder if the colour has changed.
Danish: Brug ikke pulveret, hvis farven er forandret.
English: Therefore, silica based reagents should be avoided.
Danish: Silicaholdige reagenser bør derfor undgås.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Danish: Det skal bemærkes, at ABR ikke er sammenlignelig mellem forskellige faktorkoncentrater og mellem forskellige kliniske studier.
English: Do not use Refixia:
Danish: Brug ikke Refixia:
English: Depending on the location and the severity of bleeding you may need a higher dose (80 IU per kg) or extra injections.
Danish: Afhængigt af blødningsstedet og blødningens sværhedsgrad har du muligvis brug for en højere dosis (80 IE per kg) eller yderligere injektioner.
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal standardbehandling for shock følges.
English: This new expiry date should never exceed the one initially mentioned on the outer carton.
Danish: Denne nye udløbsdato må aldrig overskride den oprindelige udløbsdato, der er angivet på den ydre karton.
English: The solvent is a histidine solution.
Danish: Solvensen er en histidinopløsning.
English: Minor surgery including tooth extraction.
Danish: Mindre kirurgi, herunder tandudtrækning.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Danish: Derfor skal patienter, der oplever allergiske reaktioner, undersøges for tilstedeværelse af en inhibitor.
English: • feeling very tired.
Danish: • udtalt træthed.
English: 40 IU/kg body weight once weekly.
Danish: 40 IE/kg legemsvægt en gang om ugen.
English: (anaphylactic reactions)
Danish: (anafylaktiske reaktioner)
English: The dose will depend on your weight and what the medicine is being used for.
Danish: Dosis afhænger af din legemsvægt, og hvad lægemidlet anvendes til.
English: In such cases, it is recommended that a specialised haemophilia centre is contacted.
Danish: I sådanne tilfælde anbefales det at kontakte et specialiseret hæmofilicenter.
English: Spike (under protective paper)
Danish: Spids (under beskyttelsespapiret)
English: No mechanism behind the tremors was identified.
Danish: Mekanismen bag denne tremor blev ikke identificeret.
English: 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 the available data).
Danish: < 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: • Wash your hands and dry them properly using a clean towel or air dry.
Danish: • Vask dine hænder, og tør dem af i et rent håndklæde, eller lufttør dem.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using Refixia.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger Refixia.
English: Additional doses of 40 IU/kg can be given.
Danish: Der kan gives yderligere doser på 40 IE/kg.
English: Factor IX is a single chain glycoprotein.
Danish: Faktor IX er et enkeltkædet glykoprotein.
English: There were no apparent differences in the pharmacokinetic profiles between normal weight and overweight patients.
Danish: Der var ingen synlige forskelle mellem den farmakokinetiske profiler hos normalvægtige og overvægtige patienter.
English: No symptoms associated with overdoses have been reported.
Danish: Der er ikke rapporteret nogen symptomer i forbindelse med overdosering.
English: Your doctor may choose another dose or how often the injections should be given, based on your need.
Danish: Din læge kan vælge en anden dosis eller ændre på, hvor ofte injektionen skal gives, ud fra dine behov.
English: It must be clear and colourless and no particles should be visible.
Danish: Den skal være klar og farveløs, og der må ikke være synlige partikler.
English: Factor IX is a protein naturally found in the blood that helps to stop bleeding.
Danish: Faktor IX er et protein, som findes naturligt i blodet, og som hjælper med at stoppe blødning.
English: Discuss with your doctor the dose and number of injections you need.
Danish: Tal med din læge om, hvilken dosis og hvor mange injektioner du har brug for.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data) • neutralising antibodies (inhibitors).
Danish: Bivirkninger med ukendt hyppighed (hyppigheden kan ikke vurderes ud fra tilgængelige data) • dannelse af neutraliserende antistoffer (inhibitorer).
English: The following side effects have been observed with Refixia:
Danish: Følgende bivirkninger er set med Refixia:
English: Do not open the equipment until you are ready to use it.
Danish: Åbn ikke udstyret, før du er klar til at bruge det.
English: Uncommon Unknown Unknown
Danish: Ikke almindelig Ikke kendt
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Danish: Trombin omdanner herefter fibrinogen til fibrin, og et koagel dannes.
English: Routine monitoring of factor IX activity levels for the purpose of dose adjustment is not necessary.
Danish: Rutinemæssig monitorering af faktor IX-aktivitetsniveauet med henblik på dosisjustering er ikke nødvendig.
English: Allergic reactions are possible with this medicine.
Danish: Der kan forekomme allergiske reaktioner med dette lægemiddel.
English: It is a vitamin-K dependent coagulation factor and it is synthesised in the liver.
Danish: Det er en vitamin K-afhængig koagulationsfaktor, der syntetiseres i leveren.
English: • Place the vial on a flat and solid surface.
Danish: • Placer hætteglasset på en flad og fast overflade.
English: Consider two repeated doses of 40 IU/kg (in 1-3 day intervals) within the first week after surgery.
Danish: Overvej to gentagne doser på 40 IE/kg (i intervaller på 1-3 dage) i den første uge efter indgrebet.
English: Factor IX is activated by factor XIa and by factor VII/tissue factor complex.
Danish: Faktor IX aktiveres af faktor XIa og af faktor VII/vævsfaktorkompleks.
English: • you suffer from other serious illness e.g. liver disease, heart disease, or cancer
Danish: • du lider af andre alvorlige sygdomme, f.eks. leversygdom, hjertesygdom eller kræft