FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that makes Trobalt must ensure that doctors who are expected to prescribe Trobalt receive an information pack containing important safety information, including information on the risk of pigment changes in the eye and discolouration of the nails, lips and skin, and on the need for a full eye examination at the start of treatment and at least every 6 months during treatment.
Danish: Virksomheden, der fremstiller Trobalt, skal sikre, at læger, som forventes at udskrive Trobalt, modtager en informationspakke, der indeholder vigtige sikkerhedsoplysninger, herunder om risikoen for pigmentændringer i øjet og misfarvning af negle, læber og hud, samt behovet for en komplet undersøgelse af øjet ved starten af behandlingen og derefter mindst hver sjette måned under behandlingen.
English: Trobalt is used in combination with other anti-epileptic medicines to treat adults with drug-resistant partial-onset seizures (epileptic fits) that cannot be treated with other combinations of medicines.
Danish: Trobalt anvendes i kombination med andre lægemidler mod epilepsi til behandling af voksne med resistente partielle anfald (epileptiske anfald), der ikke kan behandles med andre kombinationer af lægemidler.
English: The active substance in Trobalt, retigabine, is an anti-epileptic medicine.
Danish: Det aktive stof i Trobalt, retigabin, er et antiepileptikum.
English: This compared with a reduction of 13% in the placebo group.
Danish: Til sammenligning var faldet i placebogruppen 13 %.
English: Trobalt has been compared with placebo (a dummy treatment) in three main studies involving a total of 1,244 patients whose seizures were not adequately controlled with other anti-epileptic medicines.
Danish: Trobalt blev sammenlignet med placebo (en virkningsløs behandling) i tre hovedundersøgelser, som omfattede i alt 1 244 patienter, hvis anfald ikke var under tilstrækkelig kontrol med andre antiepileptika.
English: What is the risk associated with Trobalt?
Danish: Hvilken risiko er der forbundet med Trobalt?
English: For more information about treatment with Trobalt, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Trobalt, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Epilepsy is caused by excessive electrical activity in the nerve cells of the brain.
Danish: Epilepsi skyldes for stærk elektrisk aktivitet i hjernens nerveceller.
English: Trobalt acts by keeping the potassium channels open.
Danish: Trobalt virker ved at holde kaliumkanalerne åbne.
English: Trobalt at a maintenance dose of 600, 900 or 1,200 mg a day or placebo was taken for 8 weeks in the first study and 12 weeks in the other two studies.
Danish: Der blev taget Trobalt i en vedligeholdelsesdosis på 600, 900 eller 1 200 mg dagligt eller placebo i 8 uger i den første undersøgelse og i 12 uger i de øvrige to undersøgelser.
English: For more information on how to use Trobalt, including detailed recommendations for different patients groups, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger om anvendelsen af Trobalt, herunder udførlige anbefalinger til de forskellige patientgrupper, findes i produktresuméet (også en del af denne EPAR).
English: Why has Trobalt been approved?
Danish: Hvorfor blev Trobalt godkendt?
English: Trobalt is a medicine that contains the active substance retigabine.
Danish: Trobalt er et lægemiddel, der indeholder det aktive stof retigabin.
English: Trobalt has an effect on the potassium channels located on the nerve cells of the brain.
Danish: Trobalt har en effekt på kaliumkanalerne, som findes på hjernens nerveceller.
English: Trobalt must not be used in people who are hypersensitive (allergic) to retigabine or any of the other ingredients.
Danish: Trobalt må ikke anvendes til personer, som er overfølsomme (allergiske) over for retigabin eller andre af indholdsstofferne.
English: It will also include information on some less common side effects that have been reported with the medicine, such as problems with passing urine, prolonged QT interval (an alteration of the electrical activity of the heart) and hallucinations (seeing or hearing things that are not there).
Danish: Pakken vil også indeholde oplysninger om visse, mindre almindelige bivirkninger, som er blevet indberettet ved lægemidlet, såsom vandledningsproblemer, forlænget QT-interval (en ændring af den elektriske aktivitet i hjertet) og hallucinationer (opfattelsen af at se eller høre ting, som ikke er der).
English: For the full list of all side effects reported with Trobalt, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Trobalt fremgår af indlægssedlen.
English: This is a type of epilepsy where too much electrical activity in one part of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
Danish: Det en form for epilepsi, hvor for stærk elektrisk aktivitet i en side af hjernen giver symptomer som pludselige, sætvise bevægelser af en del af kroppen, forvrænget hørelse, lugt- eller synshallucinationer, følelsesløshed eller pludselig angst.
English: In the first study, Trobalt at 900 mg a day and 1,200 mg a day was more effective than placebo and reduced the number of seizures per month by 29% and 35% respectively.
Danish: I den første undersøgelse var Trobalt 900 mg dagligt og 1 200 mg dagligt mere effektivt end placebo og nedsatte antallet af anfald pr. måned med henholdsvis 29 % og 35 %.
English: The most common side effects with Trobalt (seen in more than 1 patient in 10) are dizziness, somnolence (sleepiness), fatigue (tiredness) as well as pigment changes (discolouration) of parts of the eye (including the retina, the light sensitive membrane at the back of the eye) and discolouration of the nails, lips and skin, which have been reported after several years of treatment.
Danish: De hyppigste bivirkninger ved Trobalt (som optræder hos flere end 1 ud af 10 patienter) er svimmelhed, søvnighed, træthed samt pigmentændringer (misfarvning) i dele af øjet (herunder nethinden, den lette følsomme membran bagest i øjet) og misfarvning af negle, læber og hud, som er blevet indberettet efter adskillige års behandling.
English: What is Trobalt?
Danish: Hvad er Trobalt?
English: In the second study, seizures were at least halved in 39% (61 out of 158 patients) of the patients on 600 mg Trobalt a day and in 47% (70 out of 149 patients) of the patients on 900 mg a day, compared with 19% (31 out of 164) of the patients on placebo.
Danish: I den anden undersøgelse blev anfaldene mindst halveret hos 39 % (61 ud af 158 patienter) af de patienter, som fik 600 mg Trobalt dagligt, og hos 47 % (70 ud af 149 patienter) af de patienter, som fik 900 mg dagligt, sammenlignet med 19 % (31 ud af 164) af de patienter, der fik placebo.
English: In the third study, seizures were at least halved in 56% (66 out of 119 patients) of the patients taking 1,200 mg Trobalt a day, compared with 23% (31 out of 137) of the patients on placebo.
Danish: I den tredje undersøgelse blev anfaldene mindst halveret hos 56 % (66 ud af 119 patienter) af de patienter, som tog 1 200 mg Trobalt dagligt, sammenlignet med 23 % (31 ud af 137) af de patienter, der fik placebo.
English: What is Trobalt used for?
Danish: Hvad anvendes Trobalt til?
English: How has Trobalt been studied?
Danish: Hvordan blev Trobalt undersøgt?
English: Treatment with Trobalt starts with one 100 mg tablet three times a day for one week; the dose is then increased weekly by 50 mg per dose according to the patient's response.
Danish: Dosis øges derefter hver uge med 50 mg pr. dosis, afhængigt af patientens respons.
English: What benefit has Trobalt shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Trobalt?
English: How is Trobalt used?
Danish: Hvordan anvendes Trobalt?
English: How does Trobalt work?
Danish: Hvordan virker Trobalt?
English: This is a summary of the European public assessment report (EPAR) for Veltassa.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Veltassa.
English: The full EPAR for Veltassa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Veltassa findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The maximum dose is 25.2 g once a day.
Danish: Den maksimale dosis er 25,2 g én gang dagligt.
English: The recommended starting dose is 8.4 g once a day.
Danish: Den anbefalede startdosis er 8,4 g én gang dagligt.
English: Hyperkalaemia can cause serious heart problems and muscle weakness.
Danish: Hyperkaliæmi kan forårsage alvorlige hjerteproblemer og muskelsvaghed.
English: What is Veltassa and what is it used for?
Danish: Hvad er Veltassa, og hvad anvendes det til?
English: Other information about Veltassa
Danish: Andre oplysninger om Veltassa
English: The Veltassa mixture should be taken with food and at least 3 hours before or after any other medicines the patient takes by mouth.
Danish: Veltassa-blandingen bør indtages sammen med mad og mindst 3 timer før eller efter andre lægemidler, som patienten indtager oralt.
English: The side effects are relatively moderate but the doctor should take them into account when considering treatment with Veltassa.
Danish: Bivirkningerne er forholdsvis begrænsede, men lægen bør tage hensyn til dem, når der overvejes behandling med Veltassa.
English: Veltassa contains the active substance patiromer.
Danish: Veltassa indeholder det aktive stof patiromer.
English: What measures are being taken to ensure the safe and effective use of Veltassa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Veltassa?
English: Why is Veltassa approved?
Danish: Hvorfor blev Veltassa godkendt?
English: The European Medicines Agency decided that Veltassa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Veltassa opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It is not intended to provide practical advice on how to use Veltassa.
Danish: Det er ikke en praktisk vejledning i, hvordan Veltassa bør anvendes.
English: The doctor then adjusts the dose at intervals of at least one week, based on the patient's blood levels of potassium.
Danish: Lægen tilpasser derefter dosen med intervaller på mindst en uge baseret på patientens kaliumniveau i blodet.
English: Veltassa is available as sachets (8.4, 16.8 and 25.2 g) of patiromer containing a powder for mixing with water or some fruit juices and taking by mouth.
Danish: Veltassa fås som breve (8,4 g, 16,8 g og 25,2 g) af patiromer indeholdende et pulver, der skal blandes med vand eller visse former for frugtsaft og indtages oralt.
English: What are the risks associated with Veltassa?
Danish: Hvilke risici er der forbundet med Veltassa?
English: After 4 weeks of treatment, their potassium level fell on average by 1.0 mmol/litre.
Danish: Efter 4 ugers behandling faldt deres kaliumniveau med gennemsnitligt 1,0 mmol/l.
English: The most common side effects with Veltassa (which may affect more than 1 in 100 people) are those affecting the digestive system (constipation, diarrhoea, abdominal pain and wind) and blood tests showing low levels of magnesium in the blood.
Danish: De hyppigste bivirkninger ved Veltassa (som optræder hos mere end 1 ud af 100 personer) er dem, der påvirker fordøjelsessystemet (forstoppelse, diarré, mavesmerter og luft i tarmen) og et lavt niveau af magnesium i blodet, der kan påvises gennem blodprøver.
English: For more information about treatment with Veltassa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Veltassa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: After 4 weeks, the average potassium level did not change in patients who received Veltassa for 4 weeks but it went back up by an average of 0.7 mmol/litre in patients who received placebo.
Danish: Efter fire uger ændrede det gennemsnitlige kaliumniveau sig ikke hos patienter, der modtog Veltassa i fire uger, men det steg igen med gennemsnitligt 0,7 mmol/l hos patienter, der modtog placebo.
English: When Veltassa is taken by mouth, the active substance, patiromer, remains in the gut where it attaches tightly to potassium to form a compound that is then passed out in the stool.
Danish: Når Veltassa indtages oralt, forbliver det aktive stof, patiromer, i tarmen, hvor det binder sig tæt til kalium og danner en forbindelse, der udskilles i afføringen.
English: In the first part of the study, 243 patients with hyperkalaemia (with average potassium level of 5.6 mmol/litre) were treated with Veltassa.
Danish: I den første del af undersøgelsen blev 243 patienter med hyperkaliæmi (med et gennemsnitligt kaliumniveau på 5,6 mmol/l) behandlet med Veltassa.
English: The second part of the study compared Veltassa with placebo (a dummy treatment) in 107 patients whose potassium level had fallen with Veltassa treatment during the first part of the study.
Danish: I den anden del af undersøgelsen blev Veltassa sammenlignet med placebo (en uvirksom behandling) hos 107 patienter, hvis kaliumniveau var faldet efter behandling med Veltassa i løbet den første del af undersøgelsen.
English: One main study involving patients with chronic kidney disease who had hyperkalaemia found that Veltassa is effective in reducing potassium levels in the blood.
Danish: En hovedundersøgelse, der omfattede patienter med kronisk nyresygdom, som led af hyperkaliæmi, konkluderede, at Veltassa er effektivt med hensyn til at reducere kaliumniveauet i blodet.
English: Veltassa is a medicine used for treating adults with high levels of potassium in the blood (hyperkalaemia).
Danish: Veltassa er et lægemiddel til behandling af voksne med et for højt kaliumniveau i blodet (hyperkaliæmi).
English: patiromer draws potassium from the body into the gut and so reduces the amount of potassium in the blood.
Danish: På den måde trækker patiromer kalium ud af kroppen og ind i tarmen og reducerer dermed mængden af kalium i blodet.
English: The Agency considered that there is a need for effective treatment of hyperkalaemia and Veltassa achieves a meaningful lowering of potassium levels.
Danish: Agenturet konkluderede, at der er behov for en effektiv behandling af hyperkaliæmi, og med Veltassa opnås en væsentlig reduktion af kaliumniveauerne.
English: For the full list of all side effects and restrictions with Veltassa, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Veltassa fremgår af indlægssedlen.
English: For practical information about using Veltassa, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Veltassa, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Veltassa used?
Danish: Hvordan anvendes Veltassa?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Veltassa have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Veltassa.
English: What benefits of Veltassa have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Veltassa?
English: How does Veltassa work?
Danish: Hvordan virker Veltassa?
English: Route of administration Immediate Packaging Content (concentration) Pack size
Danish: Indhold (koncentration) Paknings-størrelse
English: People handling the medicine should wash their hands after handling the product.
Danish: Personer, der håndterer lægemidlet, bør vaske hænder efter at have håndteret produktet.
English: It can only be obtained with a prescription.
Danish: Det udleveres kun efter recept.
English: This medicine is the same as NexGard, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med NexGard, som allerede er godkendt i Den Europæiske Union (EU).
English: The appropriate strength of tablets to be given is determined based on the dog's bodyweight.
Danish: Den rette tabletstyrke, der skal gives, bestemmes ud fra hundens kropsvægt.
English: Only one chewable tablet at a time should be removed from the blister to prevent children from accessing the product.
Danish: Der bør kun tages én tyggetablet ud fra blisterkortet ad gangen for at forhindre, at børn får adgang til produktet.
English: The blister with the remaining chewable tablets should be returned into the carton.
Danish: Blisterkortet med de resterende tyggetabletter bør lægges tilbage i pakningen.
English: Afoxolaner Merial received a marketing authorisation valid throughout the EU on 20 May 2019.
Danish: Afoxolaner Merial fik en markedsføringstilladelse med gyldighed i hele EU den 20. maj 2019.
English: This authorisation was based on the authorisation granted to NexGard in 2014 (‘informed consent').
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for NexGard i 2014 ("informeret samtykke").
English: Further information on Afoxolaner Merial can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/afoxolaner-merial.
Danish: Yderligere oplysninger om Afoxolaner Merial findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/afoxolaner-merial.
English: This means that it kills parasites that live on or in the skin or in the fur of animals, such as fleas, ticks and mites.
Danish: Det vil sige, at det dræber parasitter, der lever på eller i huden eller i pelsen på dyr, såsom lopper, flåter og mider.
English: Because parasites must start feeding on the dog in order to be killed by the medicine, there may be a risk of transmission of diseases with which they may be infected.
Danish: Da parasitter skal begynde at tage næring fra hunden for at blive dræbt af lægemidlet, kan det ikke udelukkes, at de kan overføre sygdomme, de kan være inficeret med.
English: Afoxolaner Merial kills fleas within 8 hours and ticks within 48 hours.
Danish: Afoxolaner Merial dræber lopper i løbet af 8 timer og flåter i løbet af 48 timer.
English: In order for the active substance to have an effect, fleas and ticks must attach to the skin and start feeding on the dog's blood.
Danish: For at det aktive stof kan virke, skal lopper og flåter først hægte sig fast i huden og begynde at tage næring fra hundens blod.
English: After being given, its actions last for at least 5 weeks against fleas and up to one month against ticks.
Danish: Efter indgivelsen holder virkningen sig i mindst 5 uger mod lopper og op til én måned mod flåter.
English: Afoxolaner kills parasites by causing over-stimulation of their nervous system.
Danish: Afoxolaner dræber parasitter ved at overstimulere deres nervesystem.
English: The company that makes NexGard has agreed that its scientific data can be used for Afoxolaner Merial (‘informed consent').
Danish: Den virksomhed, som fremstiller NexGard, har indvilget i, at dens videnskabelige oplysninger må anvendes for Afoxolaner Merial ("informeret samtykke").
English: The effectiveness of Afoxolaner Merial was investigated in both laboratory and field studies.
Danish: Virkningen af Afoxolaner Merial er undersøgt i både laboratorie- og feltstudier.
English: It may be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Danish: Det kan anvendes som led i behandlingen af loppebetinget allergisk dermatitis (en allergisk reaktion mod loppebid).
English: The European Medicines Agency decided that Afoxolaner Merial's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Afoxolaner Merial opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: Afoxolaner Merial reduced the number of fleas and ticks by at least 98% and was at least as effective as a spot-on medicine containing pyriprole (another medicine against fleas and ticks).
Danish: Afoxolaner Merial reducerede antallet af lopper og flåter med mindst 98 % og var mindst lige så effektivt som et spot-on-lægemiddel, der indeholder pyriprol (et andet lægemiddel mod lopper og flåter).
English: Treatment should be repeated at monthly intervals during the flea or tick seasons, monthly for demodectic mange until the mange is successfully treated (as confirmed by two negative skin scrapings one month apart) and monthly for two months for sarcoptic mange, or longer if treatment is unsuccessful as indicated by clinical signs and skin scrapings.
Danish: Behandlingen bør gentages med månedlige intervaller i løbet af loppe- eller flåtsæsonen, månedligt ved demodicoseskab, indtil det er lykkedes at behandle skabet (bekræftet ved to negative hudskrabninger med én måneds mellemrum) og månedligt i to måneder ved sarcoptesskab eller længere, hvis kliniske tegn og hudskrabninger viser, at behandlingen ikke har virket.
English: For more information about using Afoxolaner Merial, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Afoxolaner Merial, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Afoxolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dogs' environment.
Danish: Afoxolaner dræber lopper, før de kan lægge æg, og reducerer dermed spredningen af smitten til hundens omgivelser.
English: This results in uncontrolled activity of the nervous system and the paralysis and death of fleas, ticks and mites.
Danish: Dette medfører en ukontrolleret aktivitet i nervesystemet, så lopperne, flåterne og miderne lammes og dør.
English: Afoxolaner Merial is a veterinary medicine used to treat infestations with fleas and ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs.
Danish: Afoxolaner Merial er et lægemiddel til dyr, der anvendes til behandling af loppe- og flåtangreb såvel som demodicose- og sarcoptesskab (angreb på huden forårsaget af to forskellige typer af mider) hos hunde.
English: In an EU field study involving 146 dogs with flea and/or tick infestations, a single treatment with Afoxolaner Merial was effective in treating flea and tick infestations in dogs for up to 30 days after treatment.
Danish: I et EU-feltstudie med 146 hunde med loppe- og/eller flåtangreb var en enkelt behandling med Afoxolaner Merial effektiv mod loppe- og flåtangreb hos hunde i op til 30 dage efter behandlingen.
English: An overview of Afoxolaner Merial and why it is authorised in the EU
Danish: Oversigt over Afoxolaner Merial, og hvorfor det er godkendt i EU
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those nerves that
Danish: Det blokerer den normale transport af ladede chloridpartikler (ioner) ind og ud af nervecellerne, navnlig hos de nerver, der producerer stoffet gammaaminosmørsyre (GABA), som regulerer nervesystemet.
English: What is Afoxolaner Merial and what is it used for?
Danish: Hvad er Afoxolaner Merial, og hvad anvendes det til?
English: Afoxolaner Merial reduced the number of live mites by 96% 28 days after starting treatment and by 100% 56 days after starting treatment.
Danish: Afoxolaner Merial havde reduceret antallet af levende mider med 96% 28 dage efter behandlingsstart og med 100% 56 dage efter behandlingsstart.