FrancophonIA/ELRC3.0 huggingface dataset:
English: Intravenous bolus: may be administered directly without dilution Intravenous infusion: may be administered over 15 minutes in a compatible diluent
Danish: Intravenøs bolus: kan administreres direkte uden fortynding Intravenøs infusion: kan administreres over 15 minutter i en kompatibel fortyndingsvæske
English: The following table summarises the recommended posology for children from 4 years of age and adolescents.
Danish: Følgende tabel sammenfatter den anbefalede dosering for børn og unge fra 4 år.
English: There were no adverse effects on CNS function, neuropathological and brain histopathological examination.
Danish: Der blev ikke set uønskede virkninger på CNS-funktion ved neuropatologisk undersøgelse eller ved histopatologisk undersøgelse af hjernen.
English: Brivaracetam is cleared by multiple pathways including renal excretion, non-CYP-mediated hydrolysis and CYP-mediated oxidations.
Danish: Brivaracetam udskilles via flere veje, inklusive renal udskillelse, non-CYP-medieret hydrolyse og CYP-medieret oxidation.
English: These medicines are used to treat epilepsy.
Danish: Disse lægemidler anvendes til behandling af epilepsi.
English: If patients missed one dose or more, it is recommended that they take a single dose as soon as they remember and take the following dose at the usual morning or evening time.
Danish: Hvis patienter glemmer at tage en eller flere doser, anbefales det, at de tager en enkelt dosis, så snart de kommer i tanke om det og tager den efterfølgende dosis til sædvanlig tid om morgenen eller om aftenen.
English: The safety profile of brivaracetam observed in children was consistent with the safety profile observed in adults.
Danish: Sikkerhedsprofilen af brivaracetam observeret hos børn svarede til sikkerhedsprofilen observeret hos voksne.
English: The 5 ml oral syringe must be used in patients weighing less than 20 kg to ensure accurate dosing as the 10 ml oral syringe does not allow accurate measurements of volumes <1 ml.
Danish: Den orale 5 ml sprøjte skal bruges hos patienter, der vejer under 20 kg for at sikre korrekt dosering, da den orale 10 ml sprøjte ikke giver korrekte målinger for mængder < 1 ml.
English: Two oral syringes (5 ml and 10 ml) are included in the carton.
Danish: To orale sprøjter (5 ml og 10 ml) er vedlagt i kartonen.
English: - For the long term treatment with Briviact, your doctor will ask to you to take Briviact tablets or oral solution.
Danish: - Ved langtidsbehandling med Briviact vil lægen ordinere Briviact tabletter eller oral opløsning.
English: Therefore, starting or ending treatment with St John's wort should be done with caution.
Danish: Derfor bør initiering eller ophør af behandling med prikbladet perikum ske med forsigtighed.
English: Each carton contains 10 vials.
Danish: Hver karton indeholder 10 hætteglas.
English: People with liver problems
Danish: Personer med leverproblemer
English: Of the 130 elderly subjects enrolled in the brivaracetam phase 2/3 development program (44 with epilepsy), 100 were 65-74 years of age and 30 were 75-84 years of age.
Danish: Af de 130 ældre forsøgspersoner, som deltog i fase 2/3 i udviklingsprogrammet for brivaracetam (44 med epilepsi), var 100 i alderen 65-74 år og 30 i alderen 75-84 år.
English: How to take Briviact tablets - Swallow the tablets whole with a glass of liquid.
Danish: Sådan skal De tage Briviact tabletter - Tabletterne synkes hele sammen med et glas væske.
English: Brivaracetam was administered at weekly increasing doses of approximately 1 mg/kg/day, 2 mg/kg/day, and 4 mg/kg/day.
Danish: Brivaracetam blev administreret ved ugentligt forhøjede doser på cirka 1 mg/kg/dag 2 mg/kg/dag og 4 mg/kg/dag.
English: In case of co-administration of brivaracetam and carbamazepine, the amount of carbamazepine-epoxide excreted in breast milk could increase.
Danish: I tilfælde af samtidig administration af brivaracetam og carbamazepin kan mængden af carbamazepinepoxid i modermælken stige.
English: There was no additive effect of brivaracetam and valproate on the AUC of carbamazepine epoxide.
Danish: Der var ingen additiv effekt af brivaracetam og valproat på AUC for carbamazepinepoxid.
English: Findings not observed in clinical studies, but seen in the repeated-dose toxicology dog studies at exposure similar to the clinical plasma AUC, were hepatotoxic effects (mainly porphyria).
Danish: Fund, som ikke blev observeret i kliniske studier, men som blev set i toksikologistudier med gentagen dosering hos hunde ved eksponering svarende til klinisk plasma AUC, var hepatotoksisk virkning (hovedsageligt porfyri).
English: In safety pharmacology studies, the predominant effects were CNS related (mainly transient CNS depression and decreased spontaneous locomotor activity) seen at multiples (greater than 50 fold) of the pharmacologically active dose of brivaracetam, 2 mg/kg.
Danish: I sikkerhedsfarmakologistudier var de dominerende virkninger CNS-relaterede (hovedsageligt forbigående CNS-depression og nedsat spontan lokomotorisk aktivitet) set ved mangedobling (større end 50 gange) af den farmakologisk aktive brivaracetamdosis på 2 mg/kg.
English: A meta-analysis of randomized placebocontrolled trials of AEDs has also shown a small increased risk of suicidal ideation and behaviour.
Danish: En metaanalyse af randomiserede, placebokontrollerede studier med antiepileptika har også vist en let øget risiko for selvmordstanker og -adfærd.
English: In vivo, in human subjects possessing ineffective mutations of CYP2C19, production of the hydroxy metabolite is decreased 10-fold while brivaracetam itself is increased by 22 % or 42 % in individuals with one or both mutated alleles.
Danish: In vivo falder produktionen af hydroxymetabolitten tifoldigt hos mennesker, der har ineffektive mutationer af CYP2C19, mens brivaracetam selv stiger med 22 % eller 42 % hos personer, hvor et eller begge alleler er muteret.
English: Brivaracetam exhibits linear and time-independent pharmacokinetics with low intra- and inter-subject variability, and features complete absorption, very low protein binding, renal excretion following extensive biotransformation, and pharmacologically inactive metabolites.
Danish: Brivaracetam udviser lineær og tidsuafhængig farmakokinetik med lav intra- og interindividuel variation, samt komplet absorption, meget lav proteinbinding, renal udskillelse efter omfattende biotransformation og farmakologisk inaktive metabolitter.
English: UNIQUE IDENTIFIER - 2D BARCODE Not Applicable.
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Ikke relevant.
English: - Pull the plunger down to fill the oral syringe with a small amount of solution (figure 6).
Danish: - Træk stemplet ned for at fylde den orale sprøjte med en lille mængde opløsning (figur 6).
English: No human data on the effect of brivaracetam on fertility are available.
Danish: Der er ingen tilgængelige data vedrørende brivaracetams virkning på fertilitet.
English: How long to take Briviact for
Danish: Hvor længe skal De tage Briviact
English: There is a limited amount of data from the use of brivaracetam in pregnant women.
Danish: Der foreligger begrænsede data vedrørende brug af brivaracetam hos gravide kvinder.
English: In vitro, brivaracetam was not an inhibitor of the CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 3A4, or the transporters P-gp, BCRP, BSEP MRP2, MATE-K, MATE-1, OATP1B1, OATP1B3, OAT1 and OCT1 at clinically relevant concentrations.
Danish: In vitro, var brivaracetam ikke inhibitor af CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 3A4 eller transporterne P-gb, BCRP, BSEP, MRP2, MATE-K, MATE-1, OATP1B1, OATP1B3, OAT1 og OCT1 ved kliniske relevante koncentrationer.
English: - Wash the oral syringe with water only (figure 13).
Danish: - Skyl den orale sprøjte med rent vand (figur 13).
English: The lower efficacy observed in these patients compared to the leveticacetam-naïve patients was likely due to the higher number of prior AEDs used and higher baseline seizure frequency.
Danish: Den lavere virkning observeret hos disse patienter, sammenlignet med virkningen hos patienter, som ikke tidligere havde fået levetiracacetam, skyldtes sandsynligvis det større antal af tidligere anvendt antiepileptika samt højere anfaldsfrekvens ved baseline.
English: Figure 1: Proportion of patients by category of seizure response for brivaracetam and placebo over 12 weeks across all three double-blind pivotal trials
Danish: Antal patienter kategoriseret efter anfaldsrespons over 12 uger for brivaracetam og placebo på tværs af alle tre dobbeltblinde pivotale studier
English: This plasma concentration is slightly above the median exposure obtained after brivaracetam doses of 50 mg/day.
Danish: Denne plasmakoncentration er lidt højere end median-eksponeringen, som sås efter brivaracetamdoser på 50 mg/dag.
English: No additional safety or tolerability concern was observed (see section 5.1).
Danish: Der blev ikke observeret yderligere sikkerheds- eller tolerabilitetsproblemer (se pkt.
English: Coadministration with a high-fat meal slowed down the absorption rate (median tmax 3 h) and decreased the maximum plasma concentration (37 % lower) of brivaracetam, while the extent of absorption remained unchanged.
Danish: Samtidig administration med et fedtrigt måltid bremsede absorptionsraten (median tmax 3 timer) og sænkede den maksimale plasmakoncentration (37 % lavere) af brivaracetam, mens absorptionsgraden forblev uændret.
English: Briviact contains lactose
Danish: Briviact indeholder lactose
English: Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Danish: Briviact er indiceret som tillægsbehandling til behandling af partielle anfald med eller uden sekundær generalisering hos voksne, unge og børn fra 4 år med epilepsi.
English: Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function.
Danish: Baseret på data hos voksne er dosisjustering ikke nødvendig hos pædiatriske patienter med nedsat nyrefunktion.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX23
Danish: Farmakoterapeutisk klassifikation: antiepileptika, andre antiepileptika, ATC-kode: N03AX23
English: The safety and efficacy of brivaracetam in children aged less than 4 years have not yet been established.
Danish: Brivaracetams sikkerhed og virkning hos børn under 4 år er endnu ikke klarlagt.
English: In vitro, brivaracetam is not a substrate of human Pglycoprotein (P-gp), multidrug resistance proteins (MRP) 1 and 2, and likely not organic anion transporter polypeptide 1B1 (OATP1B1) and OATP1B3.
Danish: In vitro er brivaracetam ikke et substrat af humant P-glycoprotein (P-gp), multimedicinske resistensproteiner (MRP) 1 og 2, og sandsynligvis ikke organisk anion-transporter polypeptid 1B1 (OATP1B1) og OATP1B3.
English: The recommended starting dose is either 50 mg/day or 100 mg/day based on physician assessment of required seizure reduction versus potential side effects.
Danish: Den anbefalede initialdosis er enten 50 mg/dag eller 100 mg/dag baseret på lægens vurdering af nødvendig anfaldsreduktion versus potentielle bivirkninger.
English: Driving and using machines - You may feel sleepy, dizzy or tired while using Briviact.
Danish: Trafik- og arbejdssikkerhed - De kan føle Dem søvnig, svimmel eller træt under behandlingen med Briviact.
English: Each ml of oral solution contains 239.8 mg sorbitol (E420), 1mg methyl parahydroxybenzoate (E218) and 1.16 mg sodium.
Danish: Hver ml oral opløsning indeholder 239,8 mg sorbitol (E 420), 1 mg methylparahydroxybenzoat (E 218) og 1,16 mg natrium.
English: The pharmacokinetics of brivaracetam was not significantly affected by race (Caucasian, Asian) in a population pharmacokinetic modeling from epilepsy patients.
Danish: Brivaracetams farmakokinetik blev ikke påvirket af race (kaukasisk, asiatisk) i signifikant grad i en farmakokinetisk populationsmodellering fra epilepsipatienter.
English: Brivaracetam oral solution can be diluted in water or juice shortly before swallowing and may be taken with or without food (see section 5.2).
Danish: Brivaracetam oral opløsning kan opløses i vand eller juice umiddelbart før indtagelse og kan tages med eller uden mad (se pkt.
English: Interactions with medicinal products
Danish: Interaktion med andre lægemidler
English: Briviact tablets are packaged in blister packs supplied in cardboard boxes containing either 14, 56, 14 x 1 or 100 x 1 film-coated tablets or in multipacks containing 168 (3 packs of 56) film-coated tablets.
Danish: Briviact tabletter er pakket i blisterpakninger, som leveres i æsker indeholdende enten 14, 56, 14 x 1 eller 100 x 1 filmovertrukne tabletter eller i multipakninger indeholdende 168 (3 pakninger a 56) filmovertrukne tabletter.
English: After 1 week of treatment at 50 mg/day, a final week of treatment at the dose of 20 mg/day is recommended.
Danish: Efter 1 uges behandling med 50 mg/dag, anbefales det, at dosis i den sidste behandlingsuge er 20 mg/dag.
English: The frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥ 1/1,000 to < 1/100).
Danish: Bivirkningerne er præsenteret i rækkefølge efter faldende alvorlighed, og deres frekvens er defineret på følgende måde: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100).
English: Lacosamide
Danish: Lacosamid
English: - Turn the bottle the right way up (figure 9).
Danish: - Vend flasken den rigtige vej med toppen op (figur 9).
English: - If you weigh less than 20 kg, you should use the 5 ml oral syringe provided in the carton to ensure accurate dosing.
Danish: - Hvis du vejer under 20 kg, skal du bruge den orale 5 ml sprøjte, som er vedlagt i kartonen, for at sikre korrekt dosering.
English: Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase resulting in an increased concentration of carbamazepine epoxide, an active metabolite of carbamazepine.
Danish: Brivaracetam er en moderat reversibel inhibitor af epoxidhydrolase, hvilket resulterer i en forøget koncentration af carbamazepinepoxid, der er carbamazepins aktive metabolit.
English: Carcinogenicity studies did not indicate any oncogenic potential in rats, whereas increased incidences of hepatocellular tumors in male mice are considered to result of a non-genotoxic, mode of action linked to a phenobarbitonelike liver enzyme induction, which is a known rodent specific phenomenon.
Danish: Karcinogenicitetsstudier viste ikke onkogent potentiale hos rotter, mens øget incidens af hepatocellulære tumorer hos hanmus vurderes at skyldes en non-genotoksisk virkningsmekanisme forbundet med en phenobarbital-lignende leverenzyminduktion, hvilket er kendt som et gnaver-specifikt fænomen.
English: Apart from dose-dependent increases in incidences of somnolence and fatigue brivaracetam 50 mg/day and 100 mg/day had a similar safety profile including CNSrelated AEs and with long-term use.
Danish: Bortset fra dosisafhængige stigninger i incidensen af døsighed og træthed, havde brivaracetam 50 mg/dag og 100 mg/dag en tilsvarende sikkerhedsprofil, inklusive CNS-relaterede bivirkninger og langtidsbehandling.
English: In adults, a 50 mg/day starting dose should be considered.
Danish: Hos voksne bør en startdosis på 50 mg/dag overvejes.
English: It is used to treat a type of epilepsy that has partial seizures with or without a secondary generalisation.
Danish: - Det anvendes til behandling af en bestemt type epilepsi med ”partielle anfald med eller uden sekundær generalisering”.
English: Briviact solution for injection/infusion can be administered as a bolus injection or as an infusion:
Danish: Briviact injektions-/infusionsvæske, opløsning kan administreres som bolusinjektion eller som infusion:
English: If you are not sure, talk to your doctor or pharmacist before taking Briviact.
Danish: Hvis De er usikker, skal De tale med lægen eller apotekspersonalet, før De tager Briviact.
English: A nasogastric tube or a gastrostomy tube may be used when administering brivaracetam oral solution.
Danish: Der kan anvendes en nasogastrisk sonde eller en gastrostomisonde til administration af brivaracetam oral opløsning.
English: Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low.
Danish: Plasmakoncentrationerne af brivaracetam kan stige, når det administreres samtidig med stærke CYP2C19-hæmmere (f.eks. fluconazol, fluvoxamin), men risikoen for en klinisk relevant CYP2C19medieret interaktion anses som værende lav.
English: The most commonly taken AEDs at the time of study entry were carbamazepine (40.6 %), lamotrigine (25.2 %), valproate (20.5 %), oxcarbazepine (16.0 %), topiramate (13.5 %), phenytoin (10.2 %) and levetiracetam (9.8 %).
Danish: De mest almindelige antiepileptika, som blev taget på tidspunktet for initiering af studiet, var carbamazepin (40,6 %), lamotrigin (25,2 %), valproat (20,5 %), oxcarbazepin (16,0 %), topiramat (13,5 %), phenytoin (10,2 %) og levetiracetam (9,8 %).
English: Both metabolites, are further metabolised forming a common hydroxylated acid formed predominantly by hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9).
Danish: Begge metabolitter metaboliseres yderligere til en almindelig hydroxyleret syre dannet fortrinsvist ved hydroxylering af propyl-sidekæden på carboxylsyremetabolitten (hovedsageligt af CYP2C9).
English: Intake of brivaracetam with alcohol is not recommended.
Danish: Samtidig indtagelse af brivaracetam og alkohol anbefales ikke.
English: In the clinical studies, although the numbers were limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently.
Danish: I kliniske studier, selvom antallet var begrænset, blev der ikke observeret fordele ved brivaracetam versus placebo hos patienter, som samtidig tog levetiracetam.
English: A second disposition pathway involves hydroxylation mediated by CYP2C19 (see section 5.2).
Danish: En anden udskillelsesvej omfatter hydroxylering medieret af CYP2C19 (se pkt.
English: Allée de la Recherche 60 (address only for outer carton) B-1070 Brussels
Danish: Allée de la Recherche 60 (adresse kun for ydre karton) B-1070 Bryssel
English: It is recommended to parent and care giver to administer Briviact oral solution with the measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box.
Danish: Det anbefales, at forældre og omsorgspersoner administrerer Briviact oral opløsning ved brug af den måleenhed (10 ml eller 5 ml oral doseringssprøjte), der er vedlagt i kartonen.
English: This is because stopping treatment could increase the number of fits you have.
Danish: Dette skyldes, at stop i behandling kan medføre en stigning i antallet af kramper.
English: Each film-coated tablet contains 10 mg, 25 mg, 50mg, 75 mg, or 100 mg brivaracetam.
Danish: Hver filmovertrukken tablet indeholder 10 mg, 25 mg, 50 mg, 75 mg eller 100 mg brivaracetam.
English: There is no data on placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats (see section 5.3).
Danish: Der findes ingen data vedrørende placentapassage hos mennesker, men det blev vist, at brivaracetam let krydser placenta hos rotter (se pkt.
English: There is limited clinical experience with brivaracetam overdose in humans.
Danish: Der er begrænset klinisk erfaring vedrørende overdosering med brivaracetam hos mennesker.
English: As in adults, brivaracetam solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible.
Danish: Som hos voksne er brivaracetam injektions-/infusionsvæske, opløsning en alternativ administrationsvej for patienter, når oral administration midlertidigt ikke er mulig.
English: The daily dose of brivaracetam ranged from 5 to 200 mg/day across these studies.
Danish: Den daglige brivaracetamdosis varierede fra 5 til 200 mg/dag på tværs af studierne.
English: In rats, brivaracetam was shown to readily cross the placenta and to be excreted in milk of lactating rats with concentrations similar to maternal plasma levels.
Danish: Hos rotter blev det vist, at brivaracetam let krydser placenta, samt udskilles i modermælken i koncentrationer svarende til maternelle plasmakoncentrationer.
English: Briviact film-coated tablets contain lactose (a type of sugar).
Danish: Briviact filmovertrukne tabletter indeholder lactose (en sukkerart).
English: In clinical studies, a reduction in seizure frequency over placebo was higher with the dose of 100 mg/day than with 50 mg/day.
Danish: I kliniske studier var reduktionen i frekvensen af anfald i forhold til placebo højere med dosen på 100 mg/dag end med dosen på 50 mg/dag.
English: Very common: may affect more than 1 in 10 people - feeling sleepy or dizzy
Danish: Meget almindelig: kan forekomme hos flere end 1 ud af 10 personer - søvnighed eller svimmelhed
English: After first opening of the bottle, use within 5 months.
Danish: Skal anvendes inden for 5 måneder efter første åbning af flasken.
English: Brivaracetam is primarily metabolized by hydrolysis of the amide moiety to form the corresponding carboxylic acid (approximately 60 % the elimination), and secondarily by hydroxylation on the propyl side chain (approximately 30 % the elimination).
Danish: Brivaracetam metaboliseres primært ved hydrolyse af amid-delen til dannelse af den tilsvarende carboxylsyre (ca. 60 % af udskillelsen), og sekundært ved hydroxylering af propyl-sidekæden (ca. 30 % af udskillelsen).
English: Adverse reactions from clinical trials
Danish: Bivirkninger fra kliniske studier
English: The main disposition pathway of brivaracetam is by CYP-independent hydrolysis.
Danish: Brivaracetams vigtigste udskillelsesvej er via CYP-uafhængig hydrolyse.
English: A pharmacokinetic study in subjects with hepatic cirrhosis (Child-Pugh grades A, B, and C) showed similar increases in exposure to brivaracetam irrespective of disease severity (50 %, 57 % and 59 %), relative to matched healthy controls.
Danish: Et farmakokinetisk studie med forsøgspersoner med levercirrhose (Child-Pugh-klasse A, B og C) viste stigninger i eksponering for brivaracetam uanset sygdommens sværhedsgrad (50 %, 57 % og 59 %), der var sammenlignelige med stigninger hos raske forsøgspersoner (se pkt.
English: A maximum daily dose of 150 mg administered in 2 divided doses is recommended for all stages of hepatic impairment (see section 4.4 and 5.2).
Danish: En maksimal daglig dosis på 150 mg administreret på 2 opdelte doser anbefales ved alle stadier af nedsat leverfunktion (se pkt.
English: In healthy subjects, coadministration with the strong enzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 45 %.
Danish: Samtidig administration med den stærke enzyminducer rifampicin (600 mg/dag i 5 dage) hos raske forsøgspersoner nedsatte brivaracetam-arealet under plasmakoncentrationskurven (AUC) med 45 %.
English: CYP2B6 induction has not been investigated in vivo and brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz).
Danish: CYP2B6-induktion er ikke undersøgt in vivo og brivaracetam kan nedsætte plasmakoncentrationerne af lægemidler, som metaboliseres af CYP2B6 (f.eks. efavirenz).
English: Raspberry flavour (propylene glycol 90 % - 98 %) Purified water.
Danish: Hindbæraroma (propylenglycol 90 % - 98 %) Vand, renset.
English: In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19.
Danish: In vitro-studier har vist, at brivaracetam udviser svag eller ingen inhibition af CYP450-isoformer bortset fra CYP2C19.
English: Antiepileptic drugs
Danish: Antiepileptiske lægemidler
English: Brivaracetam may increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lanzoprazole, omeprazole, diazepam).
Danish: Brivaracetam kan øge plasmakoncentrationerne af lægemidler, som metaboliseres af CYP2C19 (f.eks. lanzoprazol, omeprazol, diazepam).