FrancophonIA/ELRC3.0 huggingface dataset:
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs), including brivaracetam, in several indications.
Danish: Selvmordstanker og -adfærd er rapporteret for flere indikationer hos patienter i behandling med antiepileptika inklusive brivaracetam.
English: Brivaracetam may also be initiated at 100 mg/day based on physician assessment of need for seizure control.
Danish: Brivaracetam kan også startes ved 100 mg/dag baseret på lægens vurdering af behovet for kontrol af krampeanfald.
English: Patients with rare heriditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: In clinical studies 2.5 % (4/161), 5.1 % (17/332) and 4.0% (10/249) of the patients on brivaracetam 50 mg/day, 100 mg/day and 200 mg/day respectively became seizure free during the 12-week treatment period compared with 0.5 % (2/418) on placebo.
Danish: I kliniske studier blev 2,5 % (4/161), 5,1 % (17/332) og 4,0 % (10/249) af patienterne, som fik henholdsvis brivaracetam 50 mg/dag, 100 mg/dag og 200 mg/dag, anfaldsfrie i løbet af en 12-ugers behandlingsperiode sammenlignet med 0,5 % (2/148) af patienterne, som fik placebo.
English: The most frequently reported adverse reactions (>10 %) with brivaracetam treatment were: somnolence (14.3 %) and dizziness (11.0 %).
Danish: De hyppigst indberettede bivirkninger (>10 %) med brivaracetambehandling var: døsighed (14,3 %) og svimmelhed (11,0 %).
English: - Open the bottle: press the cap and turn it anti-clockwise (figure 1).
Danish: - Åbn flasken: tryk låget ned og drej den mod uret (figur 1).
English: Studies in rats have shown excretion of brivaracetam in breast milk (see section 5.3).
Danish: Studier i rotter har vist, at brivaracetam udskilles i modermælk (se pkt.
English: Syringe 10 ml and 5ml (as symbols - only for the outer carton)
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Sprøjte 10 ml og 5 ml (som symboler - kun for ydre karton) UDLØBSDATO
English: Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.
Danish: Under klinisk udvikling blev der rapporteret reaktioner, som tydede på akut (type I) overfølsomhed hos et lille antal patienter, som fik brivaracetam (9/3.022).
English: In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults.
Danish: I de åbne, ukontrollerede langtidsstudier, blev der rapporteret selvmordstanker hos 4,7 % af pædiatriske patienter (mere almindelige hos unge) sammenlignet med 2,4 % af voksne, og adfærdsforstyrrelser blev rapporteret hos 24,8 % af pædiatriske patienter sammenlignet med 15,1 % af voksne.
English: - The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day.
Danish: - Den anbefalede dosis er mellem 0,5 mg og 2 mg per kg kropsvægt, som tages to gange dagligt.
English: The 300 ml glass bottle of Briviact is packed in a cardboard box containing a 10 ml oral syringe and a 5 ml oral syringe and an adaptor for the syringe.
Danish: Briviact 300 ml glasflasken er pakket i en papkarton, der indeholder en 10 ml oral sprøjte og en 5 ml oral sprøjte og en adapter til sprøjten.
English: 10 ml oral syringe provided in the carton to ensure accurate dosing.
Danish: ml sprøjte, som er vedlagt i kartonen for at sikre korrekt dosering.
English: Common: may affect up to 1 in 10 people - flu - feeling very tired (fatigue) - convulsion, a feeling of ‘spinning' (vertigo) - feeling and being sick, constipation - pain or discomfort at the injection or infusion site - depression, anxiety, not being able to sleep (insomnia), irritability - infections of the nose and throat (such as the ‘common cold'), cough - decrease appetite
Danish: Almindelig: kan forekomme hos op til 1 ud af 10 personer - influenza - voldsom træthedsfølelse - kramper, en følelse af at snurre rundt (vertigo) - kvalme eller opkastning, forstoppelse - smerte eller ubehag på injektions- eller infusionsstedet - depression, angst, søvnløshed (insomni), irritabilitet - infektioner i næsen eller halsen (såsom en ”almindelig forkølelse”), hoste - nedsat appetit
English: Statistically significant Approximately 20 % of the patients were on concomitant levetiracetam The primary outcome for N01252 did not achieve statistical significance based on the sequential testing procedure .
Danish: * Statistisk signifikant (1) Ca. 20 % af patienterne fik samtidig behandling med levetiracetam (2) På baggrund af den sekventielle testprocedure opnåede de primære endepunkter for N01252 ikke statistisk signifikans.
English: Oral dosing syringe (10 ml graduated every 0.25 ml) with an adaptor, recommended for use by patients weighing more than 20 kg or needing a dose between 50 mg and 100 mg (5 ml to 10 ml) brivaracetam per administration.
Danish: Oral doseringssprøjte (10 ml med mærke for hver 0,25 ml) med adapter, anbefalet til brug hos patienter, der vejer over 20 kg, eller som skal have en maksimal dosis på mellem 50 mg og 100 mg (5 ml til 10 ml) brivaracetam per administration.
English: Pharmacokinetic/pharmacodynamics relationship
Danish: Farmakokinetiske/farmakodynamiske forhold
English: Influence of brivaracetam on AED plasma concentration
Danish: Brivaracetams virkning på plasmakoncentrationen af antiepileptikum
English: Each millilitre (ml) contains 10 milligrams (mg) brivaracetam.
Danish: Hver milliliter (ml) indeholder 10 milligram (mg) brivaracetam.
English: Briviact is administered as an injection or infusion into a vein by a doctor or a nurse.
Danish: Briviact indgives af en læge eller sygeplejerske som en injektion eller en infusion direkte i en vene.
English: 1 - 4 mg/kg/day
Danish: 1 - 4 mg/kg/dag
English: Although the number of subjects is limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently which may reflect competition at the SV2A binding site.
Danish: Selvom antallet af forsøgspersoner var begrænset, blev der ikke observeret nogen fordel hos patienter, som tog levetiracetam og fik tillægsbehandling med brivaracetam versus patienter, som tog levetiracetam og placebo, hvilket kan afspejle konkurrence ved 2V2A-bindingsstedet.
English: The recommended maintenance dose is 2 mg/kg/day.
Danish: Den anbefalede vedligeholdelsesdosis er 2 mg/kg/dag.
English: The recommended starting dose is 50mg/day.
Danish: Den anbefalede startdosis er 50 mg/dag.
English: 14 film-coated tablets 56 film-coated tablets 100 x 1 film-coated tablet 14 x 1 film-coated tablet
Danish: 14 filmovertrukne tabletter 56 filmovertrukne tabletter 100 x 1 filmovertrukket tablet 14 x 1 filmovertrukket tablet
English: The active substance is brivaracetam.
Danish: Aktivt stof: brivaracetam.
English: Common: may affect up to 1 in 10 people - flu - feeling very tired (fatigue) - convulsion, a feeling of ‘spinning' (vertigo) - feeling and being sick, constipation - depression, anxiety, not being able to sleep (insomnia), irritability - infections of the nose and throat (such as the ‘common cold'), cough - decreased appetite
Danish: Almindelig: kan forekomme hos op til 1 ud af 10 personer - influenza - voldsom træthedsfølelse - kramper, en følelse af at snurre rundt (vertigo) - kvalme eller opkastning, forstoppelse - depression, angst, søvnløshed (insomni), irritabilitet - infektioner i næsen eller halsen (såsom en ”almindelig forkølelse”), hoste - nedsat appetit
English: Check with your doctor or pharmacist if you are not sure.
Danish: - Kontakt lægen eller apotekspersonalet, hvis De er usikker på, hvad De skal gøre.
English: The recommended maintenance dose is 100 mg/day.
Danish: Den anbefalede vedligeholdelsesdosis er 100 mg/dag.
English: In monkeys, CNS signs (prostrate, loss of balance, clumsy movements) occurred at 64 fold the clinical Cmax, these effects being less apparent over time.
Danish: Hos aber forekom der CNS-tegn (afkræftelse, tab af balance, klodsede bevægelser) ved 64 gange det kliniske Cmax.
English: In vitro, the hydroxylation of brivaracetam is mediated primarily by CYP2C19.
Danish: Hydroxyleringen af brivaracetam medieres primært af CYP2C19 in vitro.
English: Improvement in the median percent reduction in seizure frequency per 28 days has been observed in patients with type IC seizure (secondary generalized tonic-clonic seizures) at baseline treated with brivaracetam (66.6 % (n=62), 61.2 % (n=100) and 82.1 % (n=75) of the patients on brivaracetam 50 mg/day, 100 mg/day and 200 mg/day respectively as compared to placebo 33.3 % (n=115)).
Danish: Hos patienter med type IC-anfald (sekundære generaliserede tonisk-kloniske anfald) ved baseline blev der observeret forbedring af median procentvis reduktion i frekvensen af anfald pr. 28 dage (66,6 % (n=62), 61,2 % (n=100) og 82,1 % (n=75) af patienterne, som fik brivaracetam henholdsvis 50 mg/dag, 100 mg/dag og 200 mg/dag sammenlignet med 33,3 % (n=115) af patienterne, som fik placebo).
English: 5 ml oral dosing syringe
Danish: 5 ml oral doseringssprøjte
English: The dose should be administered in two equally divided doses, once in the morning and once in the evening.
Danish: Dosis skal administreres i to lige store opdelte doser, om morgenen og om aftenen.
English: Oral dosing syringe (5 ml graduated every 0.1 ml) with an adaptor, recommended for use by patients weighing less than 20 kg or needing a maximum of 50 mg (5 ml) brivaracetam per administration.
Danish: Oral doseringssprøjte (5 ml med mærke for hver 0,1 ml) medadapter, anbefalet til brug hos patienter, der vejer under 20 kg, eller som skal have en maksimal dosis på 50 mg (5 ml) brivaracetam per administration.
English: People with liver problems If you have problems with your liver: - As an adult, adolescent or child weighing 50 kg or more, the maximum dose you will take is 75 mg twice a day.
Danish: Hvis De har leverproblemer: - Som voksen, ung eller barn, der vejer 50 kg eller derover, er den maksimale dosis 75 mg to gange dagligt.
English: Croscarmellose Sodium, Lactose monohydrate Betadex
Danish: Croscarmellosenatrium Lactosemonohydrat Betadex
English: Brivaracetam oral solution contains sodium.
Danish: Brivaracetam oral opløsning indeholder natrium.
English: Briviact 10 mg/ml solution for injection/infusion 5 ml vial is packed in a carton box of 10 vials.
Danish: Briviact 10 mg/ml injektions-/infusionsvæske, opløsning 5 ml hætteglas er pakket i en karton med 10 hætteglas.
English: Children (from 4 years of age) and adolescents weighing 50 kg or more
Danish: Børn (fra 4 år eller derover) og unge, som vejer 50 kg eller derover
English: Type I hypersensitivity
Danish: Ikke almindelig Type I overfølsomhed Almindelig
English: Currently, no clinical data are available in neonates.
Danish: Der findes i øjeblikket ingen data hos nyfødte.
English: Talk to your doctor or pharmacist before using Briviact if: - You have thoughts of harming or killing yourself.
Danish: Kontakt lægen eller apotekspersonalet, før De bruger Briviact, hvis: - De har tanker om at skade Dem selv eller har selvmordstanker.
English: Briviact oral solution contains methyl parahydroxybenzoate, sodium and sorbitol Briviact oral solution contains: - methyl parahydroxybenzoate (E218) - this may cause allergic reactions (possibly delayed).
Danish: Briviact indeholder methylparahydroxybenzoat, natrium og sorbitol Briviact oral opløsning indeholder: - methylparahydroxybenzoate (E 218) - kan give allergiske reaktioner (kan optræde efter behandlingen).
English: Table 1: Pharmacokinetic interactions between brivaracetam and other AEDs AED coadministered Influence of AED on brivaracetam plasma concentration
Danish: Tabel 1: Farmakokinetiske interaktioner mellem brivaracetam og andre antiepileptika Antiepileptikum administreret samtidig
English: Briviact solution for injection/infusion contains 0.83 mmol (or 19.14 mg) sodium per vial.
Danish: Briviact injektions-/infusionsvæske, opløsning indeholder 0,83 mmol (eller 19,14 mg) natrium pr. hætteglas.
English: The minimum extractible volume is 0.25 ml which is 2.5 mg of brivaracetam.
Danish: Den minimale mængde, som kan udtrækkes, er 0,25 ml, svarende til 2,5 mg brivaracetam.
English: Talk to your doctor or pharmacist before taking Briviact if: - You have thoughts of harming or killing yourself.
Danish: Kontakt lægen eller apotekspersonalet, før De tager Briviact, hvis: - De har tanker om at skade Dem selv eller har selvmordstanker.
English: If you have more Briviact than you should If you think you have been given too much Briviact, tell your doctor straight away.
Danish: Hvis De får for meget Briviact Kontakt omgående lægen, hvis De tror, at De har fået for meget Briviact.
English: The other ingredients are: sodium acetate (trihydrate), acetic acid, glacial, sodium chloride, water for injection.
Danish: Øvrige indholdsstoffer: natriumacetat (trihydrat); krystalliseret citronsyre; natriumchlorid; vand til injektionsvæsker.
English: 10 mg/ml solution for injection/infusion is packed in 6 ml nominal capacity glass vials (type I) with siliconized bromobutyl rubber stoppers and sealed with an aluminium/polypropylene tear off cap. Each single use vial contains an extractable volume of not less than 5.0 ml of solution for injection/infusion.
Danish: 10 mg/ml injektions-/infusionsvæske, opløsningen er pakket i hætteglas af glas (type I) med en nominel kapacitet på 6 ml med silikoniserede bromobutyl gummipropper og forseglet med et aftageligt aluminium/polypropylen låg.
English: From entry into the randomized studies,5.3 % of the subjects exposed to brivaracetam for 6 months (n=1,500) were seizure free compared to 4.6 % and 3.7 % for subjects exposed for 12 months (n=1,188) and 24 months (n=847), respectively.
Danish: 5,3 % af forsøgspersonerne, som fik brivaracetam i 6 måneder (n=1.500) var anfaldsfrie sammenlignet med 4,6 % og 3,7 % af forsøgspersonerne, som fik brivaracetam i henholdsvis 12 måneder (n=1.188) og 24 måneder (n=847).
English: Upper respiratory tract infections, cough
Danish: Infektioner i de øvre luftveje, hoste
English: n= 96 n= 101
Danish: n=101
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for andre pyrrolidonderivater eller et eller flere af hjælpestofferne anført i pkt.
English: The estimated plasma clearance was 1.61 L/h, 2.18 L/h and 3.19 L/h for children weighing 20 kg, 30 kg and 50 kg, respectively.
Danish: Den estimerede plasmaclearance var 1,61 l/t, 2,18 l/t og 3,19 l/t for børn, der vejede hhv. 20 kg, 30 kg og 50 kg. Til sammenligning blev plasmaclearance estimeret til at være 3,58 l/t hos voksne patienter (kropsvægt på 70 kg).
English: No clinical data are available in neonates.
Danish: Der findes ingen kliniske data hos nyfødte.
English: Brivaracetam has not been studied in patients undergoing hemodialysis (see section 4.2).
Danish: Brivaracetam er ikke blevet undersøgt hos patienter, der får hæmodialyse (se pkt.
English: INTERMEDIATE CARTON WITHIN MULTIPACK (3 PACKS OF 56 FILM-COATED TABLETS) (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE KARTON I MULTIPAKNING (3 PAKNINGER A 56 FILMOVERTRUKNE TABLETTER) (UDEN BLÅ BOKS)
English: The solution for injection/infusion contains 0.83 mmol (or 19.14 mg) sodium per vial.
Danish: Injektions/infusionsvæsken, opløsning indeholder 0,83 mmol (eller 19,14 mg) natrium pr. hætteglas.
English: The efficacy of brivaracetam for the adjunctive therapy of partial onset seizures (POS) was established in 3 randomized, double-blind, placebo-controlled, fixed-dose, multi-center studies in subjects 16 years of age and older.
Danish: Virkningen af brivaracetam som tillægsbehandling ved partielle anfald (partial-onset seizures - POS) blev bestemt hos forsøgspersoner fra 16 år og derover i 3 randomiserede, dobbeltblinde, placebokontrollerede multicenterstudier med fast dosis.
English: If you forget to take Briviact - If you miss a dose take it as soon as you remember.
Danish: Hvis De har glemt at tage Briviact - Hvis De har glemt at tage en dosis, skal De tage den, så snart De kommer i tanker om det. - Tag derefter den næste dosis til sædvanlig tid.
English: Contains croscarmellose sodium, lactose monohydrate and lactose anhydrous.
Danish: Indeholder croscarmellosenatrium, lactosemonohydrat og lactose, vandfri.
English: The minimum extractible volume is 1 ml which is 10 mg of brivaracetam.
Danish: Den minimale mængde, som kan udtrækkes, er 1 ml, hvilket svarer til 10 mg brivaracetam.
English: One full 10 ml oral dosing syringe corresponds to 100 mg of brivaracetam.
Danish: En fuld 10 ml oral doseringssprøjte svarer til 100 mg brivaracetam.
English: What Briviact looks like and contents of the pack Briviact 10 mg/ml oral solution is slightly viscous, clear, colourless to yellowish liquid.
Danish: Briviact 10 mg/ml oral opløsning er en let tyktflydende, klar, farveløs til gullig væske.
English: Experience with epilepsy medicines suggests that the results of efficacy studies performed in adults can be extrapolated to children down to the age of 4 years provided the paediatric dose adaptations are established and safety has been demonstrated (see sections 5.2 and 4.8).
Danish: Erfaring med epilepsilægemidler indikerer, at resultaterne af effekt studier udført hos voksne kan ekstrapoleres til børn ned til en alder på 4 år, forudsat den pædiatriske dosistilpasning er fastslået, og sikkerheden er påvist (se pkt.
English: Study N01252
Danish: Studie N01252(1)
English: Do not use this medicine after the expiry date which is stated on the cardboard box and bottle after EXP.
Danish: - Tag ikke dette lægemiddel efter den udløbsdato, der står på kartonen og flasken efter EXP.
English: As from the 0.1 ml graduation mark, each graduation corresponds to 0.1 ml which is 1 mg of brivaracetam.
Danish: Fra 0,1 ml målestregen svarer hver streg til 0,1 ml, hvilket svarer til 1 mg brivaracetam.
English: Croscarmellose sodium, lactose monohydrate, betadex, lactose anhydrous, magnesium stearate
Danish: Croscarmellosenatrium; lactosemonohydrat; betadex; lactose, vandfri; magnesiumstearat.
English: Treatment with levetiracetam
Danish: Behandling med levetiracetam
English: Citric acid anhydrous (for pH-adjustment) Methyl parahydroxybenzoate (E218) Carmellose sodium
Danish: Citronsyre, vandfri (til justering af pH) Methylparahydroxybenzoat (E 218) Carmellosenatrium
English: The other ingredients are: sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), carmellose sodium, sucralose, sorbitol liquid, glycerol (E422), raspberry flavour, water, purified.
Danish: Øvrige indholdsstoffer: natriumcitrat; citronsyre, vandfri; methylparahydroxybenzoat (E 218); carmellosenatrium; sucralose; sorbitol, flydende; glycerol (E 422); hindbæraroma; vand, renset.
English: briviact 10 mg/ml (Only for outer carton)
Danish: INFORMATION I BRAILLESKRIFT briviact 10 mg/ml (Kun for ydre karton)
English: n = 252 n = 249
Danish: n=252
English: Do not stop taking this medicine unless your doctor tells you to.
Danish: Hvis De holder op med at tage Briviact - Stop ikke med at tage dette lægemiddel medmindre lægen siger, at De skal.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: - Brug ikke dette lægemiddel efter den udløbsdato, der står på kartonen og hætteglasset efter EXP.
English: In rats, there was no effect on fertility with brivaracetam (see section 5.3).
Danish: Hos rotter havde brivaracetam ingen virkning på fertilitet (se pkt.
English: Each ml contains 10 mg brivaracetam.
Danish: Hver ml indeholder 10 mg brivaracetam.
English: What you need to know before you take Briviact
Danish: Det skal De vide, før De begynder at tage Briviact
English: How to use Briviact
Danish: Sådan skal De bruge Briviact
English: Adults, adolescents and children weighing 50 kg or more - The recommended dose is from 25 mg to 100 mg taken twice a day .
Danish: Voksne, unge og børn, som vejer 50 kg eller derover - Den anbefalede dosis er mellem 25 mg og 100 mg, som tages to gange dagligt.
English: In vitro, brivaracetam did ot induce CYP1A2.
Danish: Brivaracetam inducerede ikke CYP1A2 in vitro.
English: - Briviact solution for injection/infusion is used for a short amount of time when you cannot take Briviact orally.
Danish: - Briviact injektions-/infusionsvæske, opløsning anvendes i kortere perioder, når De ikke kan tage
English: OUTER CARTON of MULTIPACK (WITH BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON AF MULTIPAKNING (MED BLÅ BOKS)
English: - Turn the bottle upside down (figure 5).
Danish: - Vend flasken på hovedet (figur 5).
English: Recommended starting dose 50 mg/day (or 100 mg/day)*
Danish: 50 mg/dag (eller 100 mg/dag)*
English: In juvenile rats, brivaracetam exposure levels 6- to 15-fold the clinical AUC exposure at the maximum recommended dose induced developmental adverse effects (i.e. mortality, clinical signs, decreased body weight and lower brain weight).
Danish: Hos juvenile rotter fremkaldte brivaracetam udviklingsmæssige uønskede virkninger (dvs. dødelighed, kliniske tegn, nedsat kropsvægt og lavere hjernevægt) ved eksponeringsniveauer på 6 til 15 gange den kliniske AUC-eksponering ved den maksimalt anbefalede dosis.
English: Children and adolescents weighing less than 50 kg - The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day.
Danish: Børn og unge, som vejer under 50 kg - Den anbefalede dosis er mellem 0,5 mg og 2 mg per hvert kg kropsvægt, som tages to gange dagligt.
English: In two phase 3 randomised placebo-controlled studies, levetiracetam was administered as concomitant AED in about 20 % of the patients.
Danish: Levetiracetam blev administreret som antiepileptisk tillægsbehandling hos ca. 20 % af patienterne i to randomiserede, placebokontrollerede fase 3 studier.
English: Dose adjustments are recommended for patients with hepatic impairment (see section
Danish: Dosisjustering anbefales hos patienter med nedsat leverfunktion (se pkt.
English: 10 ml oral dosing syringe
Danish: 10 ml oral doseringssprøjte
English: Briviact 10 mg film-coated tablets Briviact 25 mg film-coated tablets Briviact 50 mg film-coated tablets Briviact 75 mg film-coated tablets Briviact 100 mg film-coated tablets
Danish: Briviact 10 mg filmovertrukne tabletter Briviact 25 mg filmovertrukne tabletter Briviact 50 mg filmovertrukne tabletter Briviact 75 mg filmovertrukne tabletter Briviact 100 mg filmovertrukne tabletter
English: In all controlled and uncontrolled trials in patients with epilepsy, 2,388 subjects have received brivaracetam, of whom 1,740 have been treated for ≥ 6 months,1,363 for ≥ 12 months, 923 for ≥24 months and 569 for ≥ 60 months (5 years).
Danish: I alle kontrollerede og ukontrollerede studier hos patienter med epilepsi fik sammenlagt 2.388 forsøgspersoner brivaracetam, af disse blev 1.740 patienter behandlet i ≥6 måneder, 1.363 patienter blev behandlet i ≥12 måneder, 923 patienter blev behandlet i 24 måneder og 569 patienter blev behandlet i ≥60 måneder (5 år).
English: Contains sodium citrate, carmellose sodium, methyl parahydroxybenzoate (E218), sorbitol liquid and glycerol (E422).
Danish: Indeholder natriumcitrat, carmellosenatrium, methylparahydroxybenzoat (E 218), flydende sorbitol og glycerol (E 422).
English: In all controlled and uncontrolled trials in patients with epilepsy, 2,388 subjects have received brivaracetam, of whom 1,740 have been treated for ≥ 6 months,1,363 for ≥ 12 months, 923 for ≥ 24 months and 569 for ≥ 60 months (5 years).
Danish: I alle kontrollerede og ukontrollerede studier hos patienter med epilepsi fik sammenlagt 2.388 forsøgspersoner brivaracetam; af disse blev 1.740 patienter behandlet i ≥6 måneder, 1.363 patienter blev behandlet i ≥12 måneder, 923 patienter blev behandlet i 24 måneder og 569 patienter blev behandlet i ≥60 måneder (5 år).