FrancophonIA/ELRC3.0 huggingface dataset:
English: This reduces the activity of the nerve cells in the brain, reducing the intensity and the number of seizures.
Danish: Dette nedsætter aktiviteten i nervecellerne i hjernen, hvorved intensiteten og antallet af anfald reduceres.
English: Exalief should be used with caution in patients aged above 65 years because there is not enough information on the medicine's safety in these patients.
Danish: Exalief bør anvendes med forsigtighed hos patienter over 65 år, da der ikke foreligger tilstrækkelige oplysninger om lægemidlets sikkerhed hos disse patienter.
English: The full EPAR for Exalief can be found here.
Danish: Den fuldstændige EPAR for Exalief findes her.
English: The dose may be increased to 1,200 mg once a day depending on how the patient responds to treatment.
Danish: Dosis kan øges til 1 200 mg en gang dagligt afhængigt af, hvordan patienten reagerer på behandlingen.
English: The medicine is not recommended in patients with severe problems with their kidneys or liver.
Danish: Lægemidlet anbefales ikke til patienter, som har svære problemer med deres nyrer eller lever.
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 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, lugteller synshallucinationer, følelsesløshed eller pludselig angst.
English: Epilepsy is caused by excessive electrical activity in the brain.
Danish: Epilepsi skyldes for stærk elektrisk aktivitet i hjernen.
English: Three main studies were performed, involving a total of 1,050 adults with partial-onset seizures that were not controlled by other medicines.
Danish: Der blev gennemført tre hovedundersøgelser, som omfattede i alt 1 050 voksne med partielle anfald, der ikke blev reguleret med andre lægemidler.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EXALIEF EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) EXALIEF EPAR - sammendrag for offentligheden
English: Secondary generalisation occurs when the overactivity later reaches the whole brain.
Danish: Sekundær generalisering vil sige, at den stærke aktivitet senere breder sig til hele hjernen.
English: It is available as white tablets (round: 400 mg; oblong: 600 mg and 800 mg).
Danish: Det fås som hvide tabletter (runde: 400 mg, aflange: 600 mg og 800 mg).
English: The most common side effects with Exalief (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Danish: De hyppigste bivirkninger ved Exalief (som optræder hos flere end 1 ud af 10 patienter) er svimmelhed og søvntrang (søvnighed).
English: What is the risk associated with Exalief?
Danish: Hvilken risiko er der forbundet med Exalief?
English: Exalief should not be used in people who may be hypersensitive (allergic) to eslicarbazepine acetate, any of the other ingredients or other carboxamide derivatives (medicines with a similar structure to eslicarbazepine acetate, such as carbamazepine or oxcarbazepine).
Danish: Exalief må ikke anvendes af personer, der kan være overfølsomme (allergiske) over for eslicarbazepinacetat, et af de øvrige indholdsstoffer eller andre carboxamidderivater (lægemidler med en struktur, der svarer til eslicarbazepinacetat såsom carbamazepin eller oxcarbazepin).
English: For electrical impulses to travel along nerves there needs to be a rapid movement of sodium into the nerve cells.
Danish: For at de elektriske impulser kan bevæge sig langs nervebanerne, skal der være en hurtig strøm af natrium ind i nervecellerne.
English: Exalief is used to treat adults with partial-onset seizures (epileptic fits) with or without secondary generalisation.
Danish: Exalief anvendes til behandling af voksne med partielle anfald (epileptiske anfald) med eller uden sekundær generalisering.
English: Exalief should also be used with caution in patients with kidney problems and the dose should be adjusted according to how the kidneys are functioning.
Danish: Exalief bør også anvendes med forsigtighed hos patienter med nyreproblemer, og dosis skal tilpasses i overensstemmelse med, hvordan nyrerne fungerer.
English: Eslicarbazepine is thought to work by blocking ‘voltage-gated sodium channels', which stops sodium entering the nerve cells.
Danish: Eslicarbazepin menes at virke ved at blokere ‘spændings-gatede natriumkanaler', som forhindrer natrium i at trænge ind i nervecellerne.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Exalief's benefits are greater than its risks for the treatment of partial-onset seizures with or without secondary generalisation in adults who are also taking other anti-epilepsy medicines.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Exalief er større end risiciene ved behandling af partielle anfald med eller uden sekundær generalisering hos voksne, der også får andre antiepileptiske lægemidler.
English: Exalief is a medicine that contains the active substance eslicarbazepine acetate.
Danish: Exalief er et lægemiddel, som indeholder det aktive stof eslicarbazepinacetat.
English: Over the 12 weeks of treatment, this fell to 9.8 and 9 seizures per month in patients taking Exalief 800 mg and Exalief 1200 mg respectively, compared with 11.7 per month in those taking placebo.
Danish: I løbet af de 12 ugers behandling faldt dette tal til 9,8 og 9 anfald pr. måned hos patienter, som fik henholdsvis Exalief 800 mg og Exalief 1200 mg sammenlignet med 11,7 pr. måned hos dem, der fik placebo.
English: Exalief treatment starts at a dose of 400 mg once a day, before increasing it to the standard dose of 800 mg once a day after one or two weeks.
Danish: Behandlingen med Exalief indledes med en dosis på 400 mg en gang dagligt, inden denne øges til standarddosis på 800 mg en gang dagligt efter en til to uger.
English: Exalief must only be used as an ‘add-on' to other anti-epileptic medicines.
Danish: Exalief må udelukkende anvendes som en tillægsbehandling til andre lægemidler mod epilepsi.
English: Why has Exalief been approved?
Danish: Hvorfor blev Exalief godkendt?
English: Almost a half of the patients treated with Exalief experience side effects.
Danish: Næsten halvdelen af de patienter, der blev behandlet med Exalief, havde bivirkninger.
English: All three studies compared Exalief given at different doses (400 mg, 800 mg or 1200 mg once a day) with placebo (a dummy treatment).
Danish: I alle tre undersøgelser sammenlignedes Exalief givet i forskellige doser (400 mg, 800 mg eller 1200 mg en gang dagligt) med placebo (en uvirksom behandling).
English: Looking at the results of the three studies taken together, Exalief 800 mg and 1200 mg were more effective than placebo at reducing the number of seizures, when used as add-ons to other anti-epileptic medicines.
Danish: Resultaterne af de tre undersøgelser taget under et viser, at Exalief 800 mg og 1200 mg var mere effektivt end placebo til at reducere antallet af anfald, når det blev givet som tillægsbehandling til andre antiepileptiske lægemidler.
English: For the full list of all side effects reported with Exalief, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Exalief fremgår af indlægssedlen.
English: The active substance in Exalief, eslicarbazepine acetate, is converted into the anti-epileptic medicine eslicarbazepine in the body.
Danish: Det aktive stof i Exalief, eslicarbazepinacetat, omdannes i kroppen til epilepsilægemidlet eslicarbazepin.
English: What is Exalief?
Danish: Hvad er Exalief?
English: What benefit has Exalief shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Exalief?
English: How has Exalief been studied?
Danish: Hvordan blev Exalief undersøgt?
English: What is Exalief used for?
Danish: Hvad anvendes Exalief til?
English: How is Exalief used?
Danish: Hvordan anvendes Exalief?
English: How does Exalief work?
Danish: Hvordan virker Exalief?
English: Frequencies are defined as follows:
Danish: Hyppigheder er defineret som følger:
English: Therefore, both medicinal products can be administered concomitantly.
Danish: Begge lægemidler kan derfor administreres samtidig.
English: No significant difference was seen in the STEMI population.
Danish: Der blev ikke set nogen signifikant forskel i STEMI-populationen.
English: Take your dose at around the same time every day.
Danish: Tag din dosis på omtrent samme tid hver dag.
English: This concern applies especially to patients:
Danish: Denne overvejelse vedrører især følgende patienter:
English: b Other standard therapies were used as appropriate.
Danish: b Andre standardbehandlinger blev anvendt efter relevans.
English: The results of the discussion, and where appropriate the material, should be agreed with the national competent authority and be available prior to launch in each member state.
Danish: Resultaterne af diskussionen, og hvor det er relevant også materialet, bør være efter aftale med den nationale myndighed og være tilgængeligt forud for lancering i hver medlemsstat.
English: CV death
Danish: CV død
English: No dose adjustment is recommended based on ethnicity alone.
Danish: Der tilrådes ingen dosisjustering baseret på etnicitet alene.
English: All of the above may be signs of a stroke.
Danish: Alt det ovennævnte kan være tegn på et slagtilfælde.
English: Not Known
Danish: Ikke kendt
English: TTP is a serious condition and requires prompt treatment.
Danish: TTP er en kritisk tilstand og kræver øjeblikkelig behandling.
English: Package Leaflet: Information for the user
Danish: Indlægsseddel: Information til brugeren
English: Therefore, prasugrel should be used with caution in these patients.
Danish: Prasugrel bør derfor anvendes med forsigtighed til disse patienter.
English: The study failed to meet any of the primary or secondary endpoints.
Danish: Studiet mødte ikke de primære eller sekundære endepunkter.
English: • ≥ 75 years of age (see below).
Danish: • ≥ 75 år (se nedenunder).
English: This interaction may be related to reduced gastrointestinal motility and apply to other opioids.
Danish: Denne interaktion kan være relateret til nedsat gastrointestinal motilitet og gælde for andre opioider.
English: You may take Efient with or without food.
Danish: Du kan tage Efient med eller uden mad.
English: It is particularly important to tell your doctor if you are being treated with:
Danish: Det er især vigtigt at fortælle din læge, hvis du behandles med:
English: Patients may be counted in more than one row.
Danish: Patienterne kan tælles i mere end en række.
English: • Uncontrollable bleeding, for example from a cut.
Danish: • Ukontrolleret blødning fra for eksempel et snitsår.
English: Non-steroidal anti-inflammatory drugs (NSAIDs):
Danish: Non-steroide antiinflammatoriske midler (NSAIDs):
English: The patient population was 92% Caucasian, 26% female, and 39% ≥ 65 years of age.
Danish: Patientpopulationen bestod af 92 % kaukasiere, 26 % kvinder og 39 % ≥ 65 år.
English: Use of any thienopyridine within 5 days before enrolment was an exclusion criterion.
Danish: Enhver brug af thienopyridin indenfor 5 dage før inkludering var et eksklusionskriterie.
English: The benefit was primarily due to a significant decrease in non-fatal MI (see Table 3).
Danish: Fordelen skyldtes primært et signifikant fald i ikke-letale MI (se tabel 3).
English: • Sudden difficulty in walking or loss of balance or co-ordination.
Danish: • Pludseligt besvær med at gå eller problemer med balance og koordination.
English: - If you have severe liver disease.
Danish: - hvis du lider af en alvorlig leversygdom.
English: Talk to your doctor before taking Efient.
Danish: Tal med din læge før du tager Efient.
English: Hazard Ratio (HR) (95% CI)
Danish: Risikoforhold (HR) (95% CI)
English: Patients should be advised to inform physicians and dentists that they are taking prasugrel before any surgery is scheduled and before any new medicinal product is taken.
Danish: Patienterne bør rådes til at informere læger og tandlæger om, at de tager prasugrel, før nogen form for kirurgi planlægges, og før noget nyt lægemiddel tages.
English: • If you have an increased risk of bleeding such as: - age of 75 years or older.
Danish: • Hvis du har en øget risiko for blødning, for eksempel fordi: - du er 75 år eller ældre.
English: These may be signs of a severe allergic reaction (see section 2 ‘What you need to know before you take Efient').
Danish: Dette kan være tegn på en alvorlig allergisk reaktion (se afsnit 2 ”Det skal du vide, før du begynder at tage Efient”).
English: Patients ≥ 75 years old
Danish: Patienter ≥ 75 år
English: Active pathological bleeding.
Danish: Aktiv patologisk blødning.
English: Only take other medicines while you are on Efient if your doctor tells you that you can.
Danish: Tag kun anden medicin, mens du får Efient, hvis din læge siger, at du kan.
English: It is important that you tell your doctor, dentist and pharmacist, that you are taking Efient.
Danish: Det er vigtigt, at du fortæller din læge, tandlæge og på apoteket, at du tager Efient.
English: Children and adolescents Efient should not be used in children and adolescents below 18 years of age.
Danish: Børn og unge Efient må ikke anvendes af børn og unge under 18 år.
English: 85276 Pfaffenhofen Germany
Danish: 85276 Pfaffenhofen Tyskland
English: For oral use.
Danish: Til oral anvendelse.
English: Tell your doctor if you are taking morphine or other opioids (used to treat severe pain).
Danish: Fortæl din læge, hvis du tager morfin eller andre opioider (til behandling af stærke smerter).
English: The active metabolite has an elimination half-life of about 7.4 hours (range 2 to 15 hours).
Danish: Den aktive metabolit har en eliminationshalveringstid på omkring 7,4 timer (fra 2 til 15 timer).
English: Prasugrel is not detected in plasma following oral administration.
Danish: Prasugrel er ikke påvist i plasma efter oral administration.
English: You should use Efient only after discussing with your doctor the potential benefits and any potential risks to your unborn child.
Danish: Du må kun tage Efient, hvis du har talt med din læge om de mulige fordele og enhver eventuel risiko for dit ufødte barn.
English: You will start the treatment with a single dose of 60 mg.
Danish: Du vil begynde behandlingen med en enkelt dosis på 60 mg.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Efient 10 mg:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Efient 10 mg:
English: • Sudden confusion, difficulty speaking or understanding others.
Danish: • Pludselig forvirring, talebesvær eller svært ved at forstå andre.
English: The benefit of prasugrel was apparent within the first 3 days and it persisted to the end of study.
Danish: Fordelen ved prasugrel viste sig indenfor de første 3 dage og varede ved til slutningen af forsøget.
English: These patients may have an increased bleeding risk.
Danish: Disse patienter har muligvis øget blødningsrisiko.
English: In the phase 3 clinical trial, 437 patients underwent CABG during the course of the study.
Danish: I det kliniske fase 3-forsøg gennemgik 437 patienter CABG i løbet af forsøget.
English: Mechanism of action / Pharmacodynamic effects
Danish: Virkningsmekanisme/Farmakodynamisk virkning
English: • Sudden numbness or weakness of the arm, leg or face, especially if only on one side of the body.
Danish: • Pludselig følelsesløshed eller svaghed i arme, ben eller ansigt, særlig hvis det kun er i den ene side af kroppen.
English: The active metabolite's exposure (AUC) increases proportionally over the therapeutic dose range.
Danish: Den aktive metabolits eksponering (AUC) øges proportionalt over det terapeutiske dosisområde.
English: For all patients, the loading dose could be administered anytime between randomisation and 1 hour after the patient left the catheterisation lab.
Danish: For alle patienterne kunne loading-dosis administreres til enhver tid mellem randomisering og 1 time efter, at patienten forlod katerisationslaboratoriet.
English: Efient is to be administered concomitantly with acetylsalicylic acid (ASA).
Danish: Efient er beregnet til at blive administreret samtidig med acetylsalicylsyre (ASA).
English: Do not crush or break the tablet.
Danish: Undgå at knuse eller knække tabletten.
English: All of the above may be signs of bleeding, the most common side effect with Efient.
Danish: Alt det ovennævnte kan være tegn på blødning, den mest almindelige bivirkning ved Efient.
English: Bleeding risk
Danish: Blødningsrisiko
English: The benefits and risks of prasugrel should be carefully considered in patients in whom the coronary anatomy has not been defined and urgent CABG is a possibility.
Danish: Fordele og risici ved prasugrel bør overvejes omhyggeligt for de patienter, hvor den koronare anatomi ikke er defineret, og akut CABG er en mulighed.
English: Subjects with diabetes had significant reductions in the primary and all secondary composite endpoints.
Danish: Forsøgspersoner med diabetes havde signifikant reduktion i det primære og alle sekundære sammensatte endepunkter.
English: Distribution Active metabolite binding to human serum albumin (4% buffered solution) was 98%.
Danish: Fordeling Den aktive metabolits binding til humant serumalbumin (4% bufferopløsning) var 98%.
English: You should show the doctor your pack of Efient.
Danish: Du bør vise lægen pakken med Efient.
English: Because animal reproduction studies are not always predictive of a human response, Efient should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Danish: Eftersom reproduktionsforsøg hos dyr ikke altid kan forudsige det humane respons, bør Efient kun anvendes under graviditet, hvis den potentielle fordel for moderen opvejer den potentielle risiko for fostret.
English: • Sudden dizziness or sudden severe headache with no known cause.
Danish: • Pludselig svimmelhed eller pludselig, voldsom hovedpine af ukendt årsag.
English: The format and means of dissemination, of this material should be discussed with the appropriate learned societies.
Danish: Formatet og udbredelsesmåden af dette materiale bør diskuteres i passende videnskabelige fora.
English: *TRITON study in ACS patients undergoing PCI **TRILOGY-ACS study in patients not undergoing PCI (see 5.1):
Danish: *TRITON-studiet, hvor AKS-patienterne gennemgik PCI **TRILOGY-AKS-studiet, hvor patienterne ikke gennemgik PCI (se 5.1):
English: Prasugrel At time of PCIa
Danish: Prasugrel på tidspunktet for PCIa
English: Platelets are very small cell particles that circulate in the blood.
Danish: Blodplader er meget små bestanddele, som cirkulerer i blodet.
English: Avda de la Industria 30 E-28108 Alcobendas (Madrid) Spain
Danish: Avda de la Industria 30 E-28108 Alcobendas (Madrid) Spanien
English: If a patient is to undergo elective surgery, and an antiplatelet effect is not desired, Efient should be discontinued at least 7 days prior to surgery.
Danish: Hvis en patient skal have foretaget elektiv kirurgi, og antitrombotisk virkning ikke er ønskelig, bør Efient seponeres mindst 7 dage forud for indgrebet.
English: Acetylsalicylic acid:
Danish: Acetylsalicylsyre:
English: Overdose of Efient may lead to prolonged bleeding time and subsequent bleeding complications.
Danish: Overdosering af Efient kan medføre forlænget blødningstid og efterfølgende blødningskomplikationer.
English: Therefore, platelets are essential to help stop bleeding.
Danish: Blodpladerne er derfor nødvendige som hjælp til at standse blødning.
English: Table 3: Patients with Outcome Events in TRITON Primary Analysis
Danish: Tabel 3: Patienter med endepunktshændelser i TRITON primæranalysen
English: Ethnicity:
Danish: Etnicitet:
English: CABG-related bleeding
Danish: CABG-relateret blødning
English: Although uncommon, severe bleeding can be life-threatening.
Danish: Selvom det ikke er almindeligt, kan voldsom blødning være livstruende.
English: Exposure in subjects of African and Hispanic descent is comparable to that of Caucasians.
Danish: Eksponering hos forsøgspersoner af afrikansk og latin-amerikansk afstamning er sammenlignelig med den for kaukasiere.
English: No clinical study has been conducted in pregnant or breast-feeding women.
Danish: Der er ikke udført kliniske forsøg med gravide eller ammende kvinder.
English: The usual dose of Efient is 10 mg per day.
Danish: Den sædvanlige dosis er 10 mg daglig.
English: Your doctor may wish you to stop taking Efient temporarily due to the increased risk of bleeding
Danish: Din læge vil bede dig stoppe med at tage Efient midlertidigt på grund af øget risiko for blødning.
English: The rodent-specific association of liver tumours and drug-induced enzyme induction is well documented in the literature.
Danish: Den gnaverspecifikke association af levertumorer og stofinduceret enzyminduktion er veldokumenteret i litteraturen.
English: Patients had ACS with moderate to high risk UA, NSTEMI, or STEMI and were managed with PCI.
Danish: Patienterne havde AKS med moderat til høj risiko UA, NSTEMI eller STEMI og blev behandlet med PCI.
English: For the 14, 28, 56 84 and 98 tablet pack sizes, you can check the day on which you last took a tablet of Efient by referring to the calendar printed on the blister.
Danish: På pakninger med 14, 28, 56, 84 og 98 tabletter kan du se hvilken dag, du sidst tog en Efient ved at se på kalenderen, som er trykt på blisterpakningen.
English: Symptomatic ICHe
Danish: Symptomatisk ICHe
English: The observed benefit of prasugrel in patients ≥ 75 years was less than that observed in patients < 75 years.
Danish: Den observerede fordel ved prasugrel hos patienter ≥ 75 år var mindre end den, som blev observeret hos patienter < 75 år.
English: Prasugrel is a prodrug and is rapidly metabolised in vivo to an active metabolite and inactive metabolites.
Danish: Prasugrel er et prodrug og er hurtigt metaboliseret in vivo til en aktiv metabolit og inaktive metabolitter.
English: In patients with acute coronary syndrome, in whom morphine cannot be withheld and fast P2Y12 inhibition is deemed crucial, the use of a parenteral P2Y12 inhibitor may be considered.
Danish: For patienter med akut koronarsyndrom, hos hvem morfin ikke kan tilbageholdes og hurtig P2Y12-hæmning vurderes at være afgørende, kan brug af en parenteral P2Y12-inhibitor overvejes.
English: Prasugrel is a weak inhibitor of CYP2B6.
Danish: Prasugrel er en svag inhibitor af CYP2B6.
English: • Small red bruises on the skin (ecchymoses)
Danish: • Små røde pletter i huden (ekkymoser)
English: The superior efficacy was accompanied by an increase in major bleeding (see sections 4.4 and 4.8).
Danish: Den større effekt var ledsaget af en stigning i større blødninger (se pkt.4.4 og 4.8).
English: Date of latest renewal: 13 November 2013
Danish: Dato for første markedsføringstilladelse: 25. februar 2009 Dato for seneste fornyelse: 13. november 2013
English: If you miss your scheduled daily dose, take Efient when you remember.
Danish: Hvis du glemmer at tage din daglige dosis, så tag Efient, så snart du husker det.
English: Efient was administered without regard to food in TRITON.
Danish: Efient blev administreret uden hensyn til føde i TRITON.
English: Concomitant administration of Efient with coumarin derivatives other than warfarin has not been studied.
Danish: Administration af Efient samtidig med andre kumarinderivater end warfarin er ikke blevet undersøgt.