FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Keppra on 29 September 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Keppra den 29. september 2000.
English: This document is a summary of the European public assessment report (EPAR) for Keppra.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Keppra.
English: In all of these studies, the main measure of effectiveness was the change in the number of seizures before and during treatment.
Danish: I alle undersøgelserne var det primære effektmål ændringen i antallet af anfald før og under behandlingen.
English: The full EPAR for Keppra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Keppra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Keppra:
Danish: Andre oplysninger om Keppra:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Keppra.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Keppra.
English: All of the patients were taking at least one other anti-epileptic medicine.
Danish: Alle patienterne fik mindst ét andet lægemiddel mod epilepsi.
English: However, there were too few patients aged below 12 years to support the use of Keppra for this type of seizure in this age group.
Danish: Der var dog for få patienter under 12 år til at underbygge anvendelsen af Keppra til denne form for anfald i denne aldersgruppe.
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Danish: Den nøjagtige virkemåde af levetiracetam er endnu ikke klarlagt, men det ser ud til, at stoffet griber ind i funktionen af et protein kaldet det synaptiske vesikelprotein 2A, som findes i spalterne mellem nerverne, og som medvirker ved udskillelsen af kemiske signalstoffer mellem nervecellerne.
English: In both groups, 73% of the patients experienced no seizures for six months once on an adequate dose.
Danish: I begge grupper havde 73 % af patienterne ingen anfald i seks måneder efter at være nået op på en tilstrækkelig dosis.
English: The oral solution is recommended when starting treatment in children under six years old or weighing less than 25 kg.
Danish: Den orale opløsning anbefales, når der indledes behandling af børn, der er under seks år, eller som vejer under 25 kg.
English: • in partial-onset seizures, it has been studied in three main studies in a total of 904 patients aged 16 years and over.
Danish: • Til partielle anfald er det blevet undersøgt i tre hovedundersøgelser af i alt 904 patienter i alderen 16 år og derover.
English: It is available as tablets (250 mg, 500 mg, 750 mg and 1,000 mg), as an oral solution (100 mg/ml), and as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).
Danish: Det fås som tabletter (250 mg, 500 mg, 750 mg og 1 000 mg), som en oral opløsning (100 mg/ml) og som et koncentrat, der blandes til en opløsning til infusion (drop i en vene, 100 mg/ml).
English: With Keppra at a dose of 2,000 mg, the reduction was 27%, and with 3,000 mg, it was around 39%.
Danish: Med Keppra i en dosis på 2 000 mg var reduktionen 27 %, og med 3 000 mg var den ca. 39 %.
English: • partial-onset seizures with or without generalisation in patients from one month of age;
Danish: • partielle anfald med eller uden generalisering hos patienter i alderen én måned og opefter
English: The CHMP decided that Keppra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Keppra opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: This is a type of epilepsy where too much electrical activity in one side 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 er en form for epilepsi, hvor for stærk elektrisk aktivitet i én side af hjernen giver symptomer som pludselige, sætvise bevægelser af en del af kroppen, forvrænget hørelse, lugt- eller synshallucinationer, følelsesløshed eller pludselig angst.
English: This helps Keppra to stabilise electrical activity in the brain and prevent seizures.
Danish: På denne måde stabiliserer Keppra den elektriske aktivitet i hjernen og forhindrer anfald.
English: For more information about treatment with Keppra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Keppra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Keppra is a medicine that contains the active substance levetiracetam.
Danish: Keppra er et lægemiddel, der indeholder det aktive stof levetiracetam.
English: The patient's treatment was continued for 20 weeks once they were taking their full dose.
Danish: Behandlingen af patienterne fortsatte i 20 uger, når de var nået op på fuld dosis.
English: The study measured how many patients remained free of seizures for six months once they had reached their effective dose.
Danish: I undersøgelsen så man på, hvor mange patienter der var anfaldsfrie i seks måneder efter at være nået op på den effektive dosis.
English: Keppra was as effective as carbamazepine in keeping patients free of seizures when taken on its own for partial onset seizures.
Danish: Keppra var lige så effektivt som carbamazepin til at holde patienterne anfaldsfrie, når det for partielle anfald blev taget alene.
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Danish: • primære generaliserede tonisk-kloniske anfald (alvorlige krampeanfald, herunder bevidsthedstab) hos patienter fra 12-års alderen med idiopatisk generaliseret epilepsi (en form for epilepsi, som menes at have en genetisk årsag).
English: The active substance in Keppra, levetiracetam, is an anti-epileptic medicine.
Danish: Det aktive stof i Keppra, levetiracetam, er et antiepileptikum.
English: As an add-on treatment, Keppra was more effective than placebo:
Danish: Som tillægsbehandling var Keppra mere effektivt end placebo:
English: Keppra has also been compared with placebo in 314 patients aged between one month and 17 years;
Danish: Keppra blev også sammenlignet med placebo hos 314 patienter i alderen én måned til 17 år.
English: The most common side effects with Keppra (seen in more than 1 patient in 10) are nasopharyngitis (inflammation of the nose and throat), somnolence (sleepiness), and headache.
Danish: De hyppigste bivirkninger ved Keppra (som optræder hos flere end 1 ud af 10 patienter) er nasopharyngitis (betændelse i næse og svælg), somnolens (søvnighed) og hovedpine.
English: This can be increased up to 21 mg/kg twice a day.
Danish: Denne kan øges op til 21 mg/kg to gange dagligt.
English: Keppra can be given as an infusion using the same doses at the same frequency when using the tablets or the oral solution is not possible.
Danish: Keppra kan gives som en infusion i samme doser og med samme hyppighed, når det ikke er muligt at anvende tabletterne eller den orale opløsning.
English: Keppra tablets are swallowed with liquid.
Danish: Keppra-tabletterne synkes hele med væske.
English: What is the risk associated with Keppra?
Danish: Hvilken risiko er der forbundet med Keppra?
English: Keppra has also been studied as an add-on treatment:
Danish: Keppra er også blevet undersøgt som en tillægsbehandling:
English: In these studies, Keppra at doses of 1,000, 2,000 or 3,000 mg per day, was compared with placebo (a dummy treatment) over 12 to 14 weeks.
Danish: I disse undersøgelser blev Keppra i doser af 1 000, 2 000 eller 3 000 mg dagligt sammenlignet med placebo (en virkningsløs behandling) i en periode på 12 til 14 uger.
English: • for partial onset seizures, placebo treatment reduced the weekly number of seizures by 6 to 7%, while the reduction with Keppra at a dose of 1,000 mg per day was between 18 and 33%, depending on the study.
Danish: • Til partielle anfald reducerede placebobehandlingen det ugentlige antal anfald med 6-7 %, mens reduktionen med Keppra i en dosis a 1 000 mg dagligt var mellem 18 og 33 % afhængig af undersøgelsen.
English: Keppra can also be used as an add-on to other anti-epileptic medicines to treat:
Danish: Keppra kan også anvendes som en tillægsbehandling til andre antiepileptika til behandling af:
English: Keppra must not be used in people who are hypersensitive (allergic) to levetiracetam, to other pyrrolidone derivatives (medicines with a similar structure to levetiracetam), or to any of the other ingredients.
Danish: Keppra må ikke anvendes til patienter, der er overfølsomme (allergiske) over for levetiracetam, andre pyrrolidonderivater (lægemidler med en struktur, der ligner levetiracetam) eller andre af indholdsstofferne.
English: • in primary generalised tonic-clonic seizures, Keppra was compared with placebo in 164 patients aged four years or over.
Danish: • Til primære generaliserede tonisk-kloniske anfald blev Keppra sammenlignet med placebo hos 164 patienter i alderen fire år og derover.
English: For the full list of all side effects reported with Keppra, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Keppra fremgår af indlægssedlen.
English: Why has Keppra been approved?
Danish: Hvorfor blev Keppra godkendt?
English: • for tonic-clonic seizures, the number of seizures fell by an average of 28% in the patients receiving placebo, compared with 57% in those receiving Keppra.
Danish: • Til tonisk-kloniske anfald faldt antallet af anfald gennemsnitligt med 28 % hos de patienter, der fik placebo, sammenlignet med 57 % hos dem, der fik Keppra.
English: Lower doses are used in patients who have problems with their kidneys (such as older patients).
Danish: Til patienter med nyreproblemer (såsom ældre patienter) anvendes der lavere doser.
English: In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution.
Danish: Hos spædbørn i alderen mellem en og seks måneder er startdosis 7 mg/kg to gange dagligt med den orale opløsning.
English: In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Danish: Hos patienter i alderen mellem seks måneder og 17 år, som vejer under 50 kg, er startdosis 10 mg pr. kg legemsvægt to gange dagligt, hvilket kan øges til op til 30 mg/kg to gange dagligt.
English: Keppra was also more effective than placebo in children;
Danish: Keppra var hos børn også mere effektivt end placebo.
English: • in myoclonic seizures, Keppra was studied in 122 patients aged 12 years and over, who received either Keppra or placebo in addition to their normal anti-epileptic medicine for up to 30 weeks;
Danish: • Til myoklone anfald blev Keppra undersøgt hos 122 patienter i alderen 12 år og opefter, som i op til 30 uger enten fik Keppra eller placebo i tillæg til deres normale antiepileptikum.
English: Keppra used on its own has been studied in 579 patients with partial-onset seizures aged 16 years and over, who received either Keppra or carbamazepine (another anti-epileptic medicine) for up to two years.
Danish: Keppra anvendt alene blev undersøgt hos 579 patienter på 16 år og derover med partielle anfald, som enten fik Keppra eller carbamazepin (et andet antiepileptikum) i op til to år.
English: • for myoclonic seizures, the number of seizure days per week was halved in 58% of the patients receiving Keppra and in 23% of the patients receiving placebo;
Danish: • Til myoklone anfald blev antallet af daglige anfald pr. uge halveret hos 58 % af de patienter, der fik Keppra, og hos 23 % af de patienter, der fik placebo.
English: Keppra can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Danish: Keppra kan uden supplerende behandling anvendes til patienter over 16 år med nydiagnosticeret epilepsi til behandling af partielle anfald med eller uden sekundær generalisering.
English: What is Keppra?
Danish: Hvad er Keppra?
English: When Keppra is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Danish: Når Keppra anvendes alene, er startdosis 250 mg to gange dagligt, som efter to uger øges til 500 mg to gange dagligt.
English: When Keppra is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Danish: Når Keppra anvendes som tillægsbehandling til en anden behandling med antiepileptika, er startdosis til patienter over 12 år, som vejer over 50 kg, 500 mg to gange dagligt.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
Danish: • myoklone anfald (kortvarige, rykvise trækninger i en muskel eller muskelgruppe) hos patienter fra 12-års alderen med juvenil myoklon epilepsi
English: The daily dose can be increased up to 1,500 mg twice a day.
Danish: Derefter kan dosis øges indtil 1 500 mg to gange dagligt.
English: How has Keppra been studied?
Danish: Hvordan blev Keppra undersøgt?
English: The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1,500 mg twice a day.
Danish: Afhængigt af patientens reaktion på behandlingen kan dosis med to ugers mellemrum yderligere øges til en maksimal dosis på 1 500 mg to gange dagligt.
English: What benefit has Keppra shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Keppra?
English: What is Keppra used for?
Danish: Hvad anvendes Keppra til?
English: How is Keppra used?
Danish: Hvordan anvendes Keppra?
English: How does Keppra work?
Danish: Hvordan virker Keppra?
English: This summary was last updated in 02-2015.
Danish: Dette sammendrag blev sidst ajourført i 02-2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tasermity on 26 February 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tasermity den 26. februar 2015.
English: This medicine is the same as Renagel, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Renagel, som allerede er godkendt i Den Europæiske Union (EU).
English: The full EPAR for Tasermity can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tasermity 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 Tasermity.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tasermity.
English: Other information about Tasermity
Danish: Andre oplysninger om Tasermity
English: A risk management plan has been developed to ensure that Tasermity is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Tasermity anvendes så sikkert som muligt.
English: The company that makes Renagel has agreed that its scientific data can be used for Tasermity (‘informed consent').
Danish: Virksomheden, som fremstiller Renagel, har indvilget i, at dens videnskabelige oplysninger må anvendes for Tasermity (»informeret samtykke«).
English: Tasermity is available as tablets (800 mg).
Danish: Tasermity leveres som tabletter (800 mg).
English: This helps to reduce the phosphate levels in the blood.
Danish: Dette bidrager til at nedsætte fosfatindholdet i blodet.
English: What measures are being taken to ensure the safe and effective use of Tasermity?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tasermity?
English: Tasermity must be taken with meals and patients should keep to their prescribed diets.
Danish: Tasermity skal tages sammen med måltider, og patienterne skal holde deres ordinerede diæt.
English: The recommended starting dose of Tasermity is 1 or 2 tablets three times a day, depending on clinical need and the level of phosphate in the blood.
Danish: Den anbefalede startdosis for Tasermity er 1 eller 2 tabletter tre gange dagligt, afhængigt af det kliniske behov og fosfatindholdet i blodet.
English: This leads to phosphate accumulating in the body, which, in the long term, can cause complications affecting the heart and the bones.
Danish: Dette kan i det lange løb medføre komplikationer, der påvirker hjertet og knoglerne.
English: Patients with severe kidney disease cannot eliminate phosphate from their bodies.
Danish: Patienter med svær nyresygdom kan ikke udskille fosfat.
English: The most common side effects with Tasermity (which may affect more than 1 in 10 people) are nausea (feeling sick) and vomiting.
Danish: De hyppigste bivirkninger ved Tasermity (som optræder hos mere end 1 ud af 10 patienter) er kvalme og opkastning.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tasermity, 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 Tasermity, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tasermity's benefits are greater than its risks for the treatment of hyperphosphataemia and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Tasermity til behandling af hypofosfatæmi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: It is not intended to provide practical advice on how to use Tasermity.
Danish: Det er ikke en praktisk vejledning i, hvordan Tasermity bør anvendes.
English: The dose of Tasermity should be adjusted every two to three weeks to reach an acceptable level of phosphate in the blood, which should then be monitored regularly.
Danish: Dosis af Tasermity bør korrigeres hver anden til tredje uge, indtil fosfatindholdet i blodet er acceptabelt, hvorefter det bør overvåges regelmæssigt.
English: Tasermity sevelamer hydrochloride
Danish: Tasermity sevelamerhydrochlorid
English: What is Tasermity and what is it used for?
Danish: Hvad er Tasermity, og hvad anvendes det til?
English: For the full list of all side effects and restrictions with Tasermity, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Tasermity fremgår af indlægssedlen.
English: For more information about treatment with Tasermity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tasermity, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Why is Tasermity approved?
Danish: Hvorfor blev Tasermity godkendt?
English: What are the risks associated with Tasermity?
Danish: Hvilke risici er der forbundet med Tasermity?
English: It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood).
Danish: Det kan både anvendes hos patienter i hæmodialyse (hvor der bruges apparatur til at filtrere blodet) og i peritonealdialyse (hvor der pumpes væske ind i bughulen, og blodet filtreres af kroppens egen indvendige hinde).
English: The active substance in Tasermity, sevelamer hydrochloride, is a phosphate binder.
Danish: Det aktive stof i Tasermity, sevelamerhydrochlorid, er en fosfatbinder.
English: Tasermity contains the active substance sevelamer hydrochloride.
Danish: Tasermity indeholder det aktive stof sevelamerhydrochlorid.
English: Studies have shown that Tasermity significantly reduces blood phosphate levels in patients with kidney disease undergoing dialysis.
Danish: Undersøgelser har vist, at Tasermity nedsætter fosfatindholdet i blodet væsentligt hos patienter, der har nyresygdom og er i dialyse.
English: For practical information about using Tasermity, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Tasermity, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Tasermity is a medicine used to control hyperphosphataemia (high blood phosphate levels) in adult patients on dialysis (a blood clearance technique).
Danish: Tasermity er et lægemiddel, der anvendes til at kontrollere for højt fosfatindhold i blodet (hyperfosfatæmi) hos voksne patienter, der får renset blodet ved dialyse.
English: In a study of 84 patients undergoing haemodialysis, there was an average fall in phosphate levels of 0.65 mmol/l in patients taking Tasermity for 8 weeks, compared with a fall of 0.68 mmol/l in patients taking calcium acetate, another phosphate-lowering medicine.
Danish: I en undersøgelse med 84 patienter i hæmodialyse var det gennemsnitlige fald i fosfatindholdet 0,65 mmol/l hos de patienter, der fik Tasermity i 8 uger.
English: Tasermity should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Danish: For at forebygge knoglesygdom bør Tasermity anvendes sammen med andre behandlinger, såsom tilskud af calcium og D-vitamin.
English: When taken with meals, the sevelamer molecules in Tasermity attach in the gut to phosphate from food, preventing it from being absorbed into the body.
Danish: Når Tasermity tages sammen med et måltid, bliver madens indhold af fosfat bundet til sevelamermolekylerne i tarmen, så det ikke optages i kroppen.
English: What benefits of Tasermity have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Tasermity?
English: Tasermity must not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).
Danish: Tasermity må ikke anvendes hos personer med for lavt fosfatindhold i blodet (hypofosfatæmi) eller tarmslyng (ileus).
English: How is Tasermity used?
Danish: Hvordan anvendes Tasermity?
English: Similar results with Tasermity were seen in another 8-week study involving 172 haemodialysis patients, while in a third longer-term study (over 44 weeks) Tasermity led to an average fall of 0.71 mmol/l.
Danish: I en tredje, mere langvarig undersøgelse (over 44 uger) bevirkede Tasermity et gennemsnitligt fald på 0,71 mmol/l.
English: The benefit of Tasermity has also been shown in a study of 143 patients undergoing peritoneal dialysis: patients receiving Tasermity in this study had similar falls in phosphate levels over 12 weeks as the patients receiving calcium acetate (0.52 and 0.58 mmol/l, respectively).
Danish: I denne undersøgelse opnåede de patienter, der fik Tasermity, i løbet af 12 uger samme fald i fosfatindholdet som dem, der fik calciumacetat (henholdsvis 0,52 og 0,58 mmol/l).
English: How does Tasermity work?
Danish: Hvordan virker Tasermity?