FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefits of Zontivity were clearest in a group of 16,897 patients who had had a heart attack, but had no history of stroke or transient ischaemic attack (so-called ‘mini stroke').
Danish: Fordelene ved Zontivity var klarest i den undergruppe på 16 897 patienter, der havde haft et hjerteanfald, men ikke tidligere havde haft slagtilfælde eller såkaldt forbigående slagtilfælde (transitorisk iskæmisk attak).
English: The main measure of effectiveness was based on the number of patients having an ‘event' such as a heart attack or stroke, or dying from cardiovascular disease (problems affecting the heart and blood vessels).
Danish: Virkningen blev hovedsagelig bedømt på antallet af patienter, der fik en "hændelse" såsom et nyt hjerteanfald eller slagtilfælde, eller som døde af en hjerte-karsygdom (problemer, der vedrørte hjertet og blodkarrene).
English: For practical information about using Zontivity, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Zontivity, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In this group, 8.5% of patients (719 out of 8,458 patients) treated with Zontivity had an atherothrombotic event, compared with 10.3% of patients (867 out of 8,439 patients) on placebo.
Danish: I denne gruppe fik 8,5 % af de patienter (719 ud af 8 458), der blev behandlet med Zontivity, en aterotrombotisk hændelse, sammenholdt med 10,3 % (867 ud af 8 439) af dem, der fik placebo.
English: Zontivity is a medicine used to reduce the occurrence of atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes in adult patients who have already had a heart attack or who have peripheral arterial disease (problem with blood flow in the arteries) with symptoms.
Danish: Zontivity er et lægemiddel, der anvendes til at mindske forekomsten af blodpropper og stivhed i arterierne (aterotrombotiske hændelser) såsom nye hjerteanfald eller slagtilfælde hos voksne patienter, der tidligere har haft et hjerteanfald, eller som har problemer med blodgennemstrømningen i arterierne (perifer arteriesygdom) med symptomer.
English: It is given in combination with either aspirin or, where appropriate, with clopidogrel.
Danish: Det gives i kombination med enten aspirin eller, hvis det er relevant, med clopidogrel.
English: Overall, 9.5% of patients (1,259 out of 13,225 patients) taking Zontivity had an atherothrombotic event compared with 10.7% (1,417 out of 13,224 patients) of patients taking placebo.
Danish: Samlet fik 9,5 % af de patienter (1 259 ud af 13 225 patienter), der fik Zontivity, en aterotrombotisk hændelse, sammenholdt med 10,7 % (1 417 ud af 13 224) af dem, der fik placebo.
English: Among patients with peripheral arterial disease, 10.9% (177 out of 1,622 patients) taking Zontivity had an atherothrombotic event compared with 12.5% (206 out of 1,651 patients) of patients taking placebo.
Danish: Blandt patienter med perifær arteriesygdom fik 10,9 % (177 ud af 1 622 patienter) af de patienter, der fik Zontivity, en aterotrombotisk hændelse, sammenholdt med 12,5% (206 ud af 1 651) af dem, der fik placebo.
English: It is given in combination with aspirin and where appropriate, clopidogrel.
Danish: Det gives i kombination med aspirin og, hvis det er relevant, med clopidogrel.
English: What benefits of Zontivity have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zontivity?
English: Regarding Zontivity's safety profile, the CHMP was concerned about the risk of bleeding in patients taking Zontivity on top of their standard therapy, particularly serious bleeding which was more frequent in patients with a history of stroke.
Danish: Vedrørende sikkerhedsprofilen for Zontivity var der i CHMP betænkelighed ved risikoen for blødning hos patienter, der får Zontivity som tillægsbehandling til deres sædvanlige behandling.
English: For the full list of all side effects, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zontivity have 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 Zontivity.
English: The active substance in Zontivity, vorapaxar, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Zontivity, vorapaxar, hæmmer sammenklumpning af blodpladerne.
English: How does Zontivity work?
Danish: Hvordan virker Zontivity?
English: There are limited data on the use of Zontivity for longer than 2 years; therefore, after 2 years of treatment, the benefits and risks of Zontivity should be re-evaluated in individual patients by the treating doctor.
Danish: Derfor bør lægen tage fordele og risici ved Zontivity for den enkelte patient op til ny vurdering efter to års behandling.
English: When the blood clots, components in the blood called platelets stick together.
Danish: Når blod størkner, sker der en sammenklumpning af særlige celler i blodet, blodpladerne.
English: How is Zontivity used?
Danish: Hvordan anvendes Zontivity?
English: It is given in combination with aspirin (acetylsalicylic acid) and where appropriate with a third medicine, clopidogrel, both of which also help prevent atherothrombotic events.
Danish: Når det er hensigtsmæssigt, gives det desuden i kombination med et tredje lægemiddel, clopidogrel, der også begrænser aterotrombotiske hændelser.
English: Blocking the PAR-1 receptor stops the platelets becoming sticky, reducing the risk of a blood clot forming and helping to prevent a stroke or heart attack.
Danish: Dette mindsker risikoen for blodpropper og er med til at forebygge nye slagtilfælde eller hjerteanfald.
English: MA (EU) number
Danish: MF (EU)-nummer Særnavn Styrke
English: Oral suspension Oral use bottle (glass); syringe (PET)
Danish: Oral suspension Oral anvendelse Glasflaske; injektionssprøjte (PET)
English: 1 bottle + 1 bottle adaptor + 2 oral syringes
Danish: 1 flaske + 1 flaskeadapter + 2 orale injektionssprøjter
English: Hands and equipment should be washed and disinfected after use.
Danish: Hænder og udstyr skal vaskes og desinficeres efter brug.
English: This will help protect against coccidiosis.
Danish: Dette er med til at beskytte mod coccidiose.
English: Evalon is a vaccine.
Danish: Evalon er en vaccine.
English: The full EPAR for Evalon can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Evalon findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Evalon avian coccidiosis vaccine (live)
Danish: Evalon aviær coccidiosevaccine (levende)
English: The European Commission granted a marketing authorisation valid throughout the EU for Evalon on
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Evalon den
English: Protection starts at 3 weeks after vaccination and lasts until 60 weeks after vaccination.
Danish: Beskyttelsen begynder 3 uger efter vaccinationen og varer i 60 uger efter vaccinationen.
English: This is a summary of the European public assessment report (EPAR) for Evalon.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Evalon.
English: The withdrawal period for meat and eggs from chickens treated with Evalon is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød og æg fra kyllinger, der behandles med Evalon, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Danish: Det forklarer, hvordan agenturet vurderede dette lægemiddel til dyr for at kunne anbefale udstedelse af en markedsføringstilladelse i Den Europæiske Union (EU) og dets anvendelsesbetingelser.
English: In the future if the animals are exposed to the same Eimeria species the immune system will be able to respond more quickly.
Danish: Hvis dyrene efterfølgende udsættes for samme Eimeria-art, vil immunsystemet blive i stand til at reagere hurtigere.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Evalon'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 Evalon opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The vaccine suspension should be diluted with the solvent and water according to dosing instructions and sprayed onto the birds so that each bird receives one dose.
Danish: Vaccineopslæmningen fortyndes med opløsningsvæske og vand i henhold til doseringsanvisningerne og sprayes på fuglene, så hver fugl får én dosis.
English: There are no known side effects with Evalon.
Danish: Der er ingen kendte bivirkninger ved Evalon.
English: Coccidiosis is a disease of the gut which results in reduced growth, severe diarrhoea, reduced egg production and a high death rate.
Danish: Coccidiose er en tarmsygdom, der medfører nedsat vækst, svær diarré, nedsat ægproduktion og høj dødelighed.
English: When Evalon is given to chickens, the animals' immune system recognises the Eimeria oocysts as foreign and makes defences against them.
Danish: Når Evalon gives til kyllinger, registrerer dyrenes immunsystem Eimeria-oocysterne som fremmede og danner forsvar mod dem.
English: Why is Evalon approved?
Danish: Hvorfor blev Evalon godkendt?
English: The vaccine contains the oocysts of Eimeria species that have been weakened so that they cannot cause disease.
Danish: Vaccinen indeholder oocyster af Eimeria, som er svækket, så de ikke kan forårsage sygdom.
English: It is not intended to provide practical advice on how to use Evalon.
Danish: Det er ikke en praktisk vejledning i, hvordan Evalon bør anvendes.
English: What is Evalon and what is it used for?
Danish: Hvad er Evalon, og hvad anvendes det til?
English: The vaccine is given to one-day-old chicks by coarse spray vaccination.
Danish: Vaccinen gives til daggamle kyllinger ved grov sprayvaccination.
English: The vaccine solvent contains the adjuvant montanide IMS to enhance the immune response.
Danish: Vaccinens opløsningsvæske indeholder adjuvanset montanide IMS for at styrke immunreaktionen.
English: Evalon is available as a suspension and solvent and can only be obtained with a prescription.
Danish: Evalon fås som en opslæmning (suspension) med opløsningsvæske (solvens) og udleveres kun efter recept.
English: Infected birds shed disease spores (oocysts) in their faeces that can spread the infection.
Danish: Inficerede fugle udskiller sporer (oocyster) i afføringen, hvilket kan sprede infektionen.
English: What are the risks associated with Evalon?
Danish: Hvilke risici er der forbundet med Evalon?
English: In a field study involving 4 farms, shedding of oocysts in the faeces was reduced within 3 weeks of vaccination both in Evalon vaccinated chicks and those vaccinated with another vaccine against Eimeria.
Danish: I en feltundersøgelse i fire fjerkræbrug blev udskillelsen af oocyster i afføringen nedsat inden for 3 uger efter vaccination både fra kyllinger, der var vaccineret med Evalon, og fra dem, der var vaccineret med en anden vaccine mod Eimeria.
English: The results with Evalon and the comparator vaccine were similar for 3 out 4 farms; on 1 farm Evalon vaccinated chickens showed better protection than those given the comparator.
Danish: Resultaterne med Evalon og sammenligningsvaccinen svarede til hinanden i 3 ud af 4 brug; på ét brug udviste de kyllinger, der var vaccineret med Evalon, bedre beskyttelse end de, der havde fået sammenligningsvaccinen.
English: Evalon is a veterinary vaccine to protect chickens against coccidiosis caused by the coccidia parasites Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Danish: Evalon er en vaccine til beskyttelse af kyllinger mod coccidiose forårsaget af coccidia-parasitterne Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix og Eimeria tenella.
English: The vaccine contains live attenuated (weakened) oocysts of Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Danish: Vaccinen indeholder svækkede oocyster af Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix og Eimeria tenella.
English: Other information about Evalon?
Danish: Andre oplysninger om Evalon
English: The birds consume the vaccine when preening their feathers.
Danish: Fuglene indtager vaccinen, når de pudser fjerene.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Evalon, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Evalon, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: How does Evalon work?
Danish: Hvordan virker Evalon?
English: How is Evalon used?
Danish: Hvordan anvendes Evalon?
English: What benefits of Evalon have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Evalon?
English: For more information about treatment with Evalon, 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 Evalon, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Evalon, 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 Evalon, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: MA (EU) Numbers (Invented) name Strength
Danish: MT (EU) Nummer (Særnavn)navn Styrke
English: Immediate Packaging Pack size blister (PVC/PVDC-Alu); wallet blister (PVC/PVDC-AluAlu); carton
Danish: Filmovertrukket tablet Oral anvendelse blister (PVC/PVDCAlu); lomme
English: It is given once a day by slow infusion lasting about one hour.
Danish: Det gives én gang dagligt ved langsom infusion i løbet af cirka en time.
English: In patients between 12 months and 17 years of age, the dose depends on body surface area (calculated using the patient's height and weight).
Danish: Hos patienter mellem 12 måneder og 17 år afhænger dosis af legemsoverfladen (beregnet ved hjælp af patientens højde og vægt).
English: Caspofungin Accord should be used with caution in children below 12 months of age, because it has not been studied sufficiently in this age group.
Danish: Caspofungin Accord bør anvendes med forsigtighed hos børn under 12 måneder, da det ikke er undersøgt tilstrækkeligt hos denne aldersgruppe.
English: In adults, treatment begins with a 70mg starting dose, followed by a daily dose of 50 mg, or of 70 mg if the patient weighs more than 80 kg. A lower dose is given to adults who have moderate problems with their liver.
Danish: Hos voksne begynder behandlingen med en 70 mg startdosis, efterfulgt af en daglig dosis på 50 mg, dog 70 mg hvis patienten vejer over 80 kg. Ved moderate leverproblemer hos voksne gives en lavere dosis.
English: The full EPAR and risk management plan summary for Caspofungin Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Caspofungin Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Caspofungin Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Caspofungin Accord.
English: The Committee recommended that Caspofungin Accord be approved for use in the EU.
Danish: Udvalget anbefalede, at Caspofungin Accord godkendes til anvendelse i EU.
English: This means that Caspofungin Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cancidas.
Danish: Det betyder, at Caspofungin Accord er identisk med til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Cancidas.
English: A risk management plan has been developed to ensure that Caspofungin Accord is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Caspofungin Accord anvendes så sikkert som muligt.
English: It contains the active substance caspofungin.
Danish: Det indeholder det aktive stof caspofungin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Caspofungin Accord has been shown to be comparable to Cancidas.
Danish: Udvalget for humanmedicinske lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Caspofungin Accord er sammenligneligt med Cancidas.
English: Caspofungin Accord is an antifungal medicine used to treat adults, adolescents and children with:
Danish: Caspofungin Accord er et lægemiddel, der anvendes til behandling af voksne, unge og børn med:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Caspofungin Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Caspofungin Accord, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Because Caspofungin Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Caspofungin Accord er et generisk lægemiddel, antages det at have de samme fordele og risici som referencelægemidlet.
English: No additional studies in humans were needed as Caspofungin Accord is a generic medicine that is given by infusion and contains the same active substance as Cancidas.
Danish: Der behøvedes ikke flere undersøgelser hos patienter, da Caspofungin Accord er et generisk lægemiddel, som gives ved infusion og indeholder samme aktive stof som Cancidas.
English: Caspofungin Accord is a ‘generic medicine'.
Danish: Caspofungin Accord er et "generisk lægemiddel".
English: Other information about Caspofungin Accord
Danish: Andre oplysninger om Caspofungin Accord
English: Caspofungin Accord can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of invasive fungal infections.
Danish: Caspofungin Accord udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af invasive svampeinfektioner.
English: Caspofungin Accord must be made up into a concentrated solution and then diluted before use, using a diluent that does not contain glucose.
Danish: Caspofungin Accord skal tilberedes som en koncentreret opløsning og derefter fortyndes inden brug ved hjælp af en fortyndingsvæske, der ikke indeholder glukose.
English: It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide', which is necessary for the fungus to survive and grow.
Danish: Det virker ved at gribe ind i produktionen af et polysacharid af glucantypen, der er en del af svampens cellevæg og nødvendigt for at svampen fortsat kan leve og vokse.
English: What are the benefits and risks of Caspofungin Accord?
Danish: Hvilke fordele og risici er der forbundet med Caspofungin Accord?
English: • invasive aspergillosis (another type of fungal infection due to Aspergillus) when the infection does not respond to or the patient does not tolerate amphotericin B or itraconazole (other antifungal medicines);
Danish: • invasiv aspergillose (en anden form for infektion, der skyldes svampe af arten Aspergillus), når de andre svampemidler amphotericin B og/eller itraconazol ikke virker på infektionen eller ikke tåles af patienten,
English: • invasive candidiasis (a type of fungal infection due to Candida);
Danish: • invasiv kandidose (en infektion med svampe af arten Candida),
English: Therefore, the CHMP's view was that, as for Cancidas, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Cancidas.
English: It is not intended to provide practical advice on how to use Caspofungin Accord.
Danish: Det er ikke en praktisk vejledning i, hvordan Caspofungin Accord bør anvendes.
English: For more information about treatment with Caspofungin Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Caspofungin Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Caspofungin Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Caspofungin Accord?
English: Fungal cells treated with Caspofungin Accord have incomplete or defective cell walls, making them fragile, unable to grow and causing their death.
Danish: Ved behandling med Caspofungin Accord bliver svampecellernes cellevæg svækket eller defekt, så de bliver skrøbelige og ude af stand til at vokse.
English: What is Caspofungin Accord and what is it used for?
Danish: Hvad er Caspofungin Accord, og hvad anvendes det til?
English: The company provided data from the published literature on caspofungin.
Danish: Virksomheden fremlagde data fra faglitteraturen om caspofungin.
English: For practical information about using Caspofungin Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Caspofungin Accord, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Caspofungin Accord is a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Caspofungin Accord er et pulver, som bruges til at fremstille en væske til indgift med drop i en vene (infusionsvæske).
English: The active substance in Caspofungin Accord, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins'.
Danish: Det aktive stof i Caspofungin Accord, caspofungin, er et lægemiddel i gruppen af echinocandiner.
English: The list of fungi against which Caspofungin Accord is active can be found in the summary of product characteristics (also part of the EPAR).
Danish: En liste over de svampe, som Caspofungin Accord virker mod, findes i produktresuméet, der også er en del af denne EPAR.
English: • suspected fungal infections (such as due to Candida or Aspergillus) when the patient is febrile
Danish: • ved mistanke om svampeinfektion (f.eks. forårsaget af Candida eller Aspergillus), når patienten har feber og for lavt antal hvide blodlegemer (neutropeni).
English: Why is Caspofungin Accord approved?
Danish: Hvorfor blev Caspofungin Accord godkendt?
English: How has Caspofungin Accord been studied?
Danish: Hvordan blev Caspofungin Accord undersøgt?
English: How is Caspofungin Accord used?
Danish: Hvordan anvendes Caspofungin Accord?
English: How does Caspofungin Accord work?
Danish: Hvordan virker Caspofungin Accord?
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmith Kline
Danish: Prepandemisk influenza vaccine (H5N1) (split virion, inaktiveret, adjuveret) GlaxoSmithKline Biologicals µg HA