FrancophonIA/ELRC3.0 huggingface dataset:
English: - You can switch between taking Briviact orally to the solution for injection/infusion, and the other way around.
Danish: - De kan skifte mellem at tage Briviact gennem munden og som injektion/infusion, eller omvendt.
English: Since less than 10 % of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance (see section 5.2).
Danish: Da mindre end 10 % af brivaracetam udskilles via urinen, forventes hæmodialyse ikke at øge clearance af brivaracetam i signifikant grad (se pkt.
English: Gender There are no clinically relevant differences in the pharmacokinetics of brivaracetam by gender.
Danish: Køn Der er ingen klinisk relevante kønsforskelle i brivaracetams farmakokinetik.
English: Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required (see table 1).
Danish: Plasmakoncentrationerne af brivaracetam nedsættes ved samtidig administration af stærke enzyminducerende antiepileptika (carbamazepin, phenobarbital, phenytoin), men dosisjustering er ikke nødvendig (se tabel 1).
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a box also containing a 5 ml and 10 ml graduated oral dosing syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Danish: 300 ml brun glasflaske (type III) med en hvid, børnesikret lukning (polypropylen) i en karton, der også indeholder en 5 ml og 10 ml gradueret oral doseringssprøjte (polypropylen, polyethylen) og en adapter til sprøjten (polyethylen).
English: Doses in patients from 4 years of age were defined by weight-based dose adaptations which have been established to achieve similar plasma concentrations to the ones observed in adults taking efficacious doses (section 5.2).
Danish: Doser hos patienter fra 4 år blev bestemt ved dosistilpasning baseret på vægt, hvilket er påvist at føre til tilsvarende plasmakoncentrationer som set hos voksne, der tager en effektiv dosis (pkt.
English: Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Danish: Indehaver af markedsføringstilladelsen UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bryssel, Belgien
English: Titanium dioxide (E171) Macrogol 3350
Danish: Titandioxid (E 171) Macrogol 3350
English: Follow these steps the first time you take Briviact: - Take off the adaptor from the oral syringe (figure 2).
Danish: Følg disse trin første gang De tager Briviact: - Tag adapteren af den orale sprøjte (figur 2).
English: Embryotoxicity was observed in rabbits at a maternal toxic dose of brivaracetam with an exposure level 8-fold the clinical AUC exposure at the maximum recommended dose.
Danish: Der blev observeret embryotoksicitet hos kaniner ved en maternel toksisk brivaracetamdosis svarende til et eksponeringsniveau, der var 8 gange større end den kliniske AUCeksponering ved den maksimalt anbefalede dosis.
English: Each vial of Briviact solution for injection/infusion must be used only once (single use).
Danish: Hvert hætteglas med Briviact injektions-/infusionsvæske, opløsning må kun anvendes en gang (engangsbrug).
English: A study in subjects with severe renal impairment (creatinine clearance <30 ml/min/1.73 m² and not requiring dialysis) revealed that the plasma AUC of brivaracetam was moderately increased (+21 %) relative to healthy controls, while the AUC of the acid, hydroxy and hydroxyacid metabolites were increased 3-, 4-, and 21-fold, respectively.
Danish: Nedsat nyrefunktion Et studie med forsøgspersoner med nedsat nyrefunktion (kreatinclearance <30 ml/min/1,73 m2 og ikke dialysekrævende) viste, at brivaracetams plasma-AUC var øget i moderat grad (+21 %) i forhold til hos raske forsøgspersoner, mens AUC af syre-, hydroxy- og hydroxysyremetabolitterne blev øget henholdsvis 3-, 4- og 21-fold.
English: Brivaracetam solution for injection/infusion is an alternative for patients when oral administration is temporarily not feasible.
Danish: Brivaracetam injektions-/infusionsvæske, opløsning er et alternativ til patienter, når oral administration midlertidigt ikke er mulig.
English: Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A), a transmembrane glycoprotein found at presynaptic level in neurons and in endocrine cells.
Danish: Brivaracetam viser en høj og selektiv affinitet for til det synaptiske vesikelprotein 2A (SV2A), som er et transmembrant glycoprotein, som findes på præsynaptisk niveau i neuroner og endokrine celler.
English: No adverse liver changes were seen in rats and monkeys following chronic administration of brivaracetam at 5- and 42fold the clinical AUC exposure.
Danish: Der blev ikke set negative leverændringer hos rotter og aber efter kronisk administration af brivaracetam ved doser, der var 5 og 42 gange større end den kliniske AUCeksponering.
English: Solution for injection/infusion (injection/infusion) Clear, colourless, solution.
Danish: Injektions-/infusionsvæske, opløsning (injektion/infusion) Klar, farveløs opløsning.
English: When tested in vitro brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6.
Danish: Ved undersøgelse in vitro inducerede brivaracetam ikke CYP1A1/2, men forårsagede induktion af CYP3A4 og CYP2B6.
English: In a third study, a pre-specified analysis demonstrated efficacy over placebo for 100 mg/day and 200 mg/day in patients with prior exposure to levetiracetam.
Danish: I et tredje studie viste en præspecificeret analyse virkning for 100 mg/dag og 200 mg/dag set i forhold til placebo hos patienter med tidligere eksponering for levetiracetam.
English: In vitro interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3.
Danish: In vitro-interaktionsstudier, som havde til formål at vurdere den potentielle inhibitoriske virkning på transportører, konkluderede, at der ikke var klinisk relevante virkninger, bortset fra OAT3.
English: Animal studies did not detect any teratogenic potential of brivaracetam (see section 5.3).
Danish: Dyrestudier har ikke påvist teratogent potentiale for brivaracetam (se pkt.
English: If brivaracetam has to be discontinued it is recommended to withdraw it gradually by 50 mg/day on a weekly basis.
Danish: Hvis behandlingen med brivaracetam skal seponeres, anbefales det at seponere brivaracetam gradvist med 50 mg/dag hver uge.
English: Do not use Briviact if: - you are allergic to brivaracetam, other pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Briviact, hvis: - De er allergisk over for brivaracetam, andre pyrrolidonderivater eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: - Periodic safety update reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Stopping treatment could increase your seizures and harm your baby.
Danish: Ophør af behandling kan øge antallet af anfald og skade Deres barn.
English: Briviact is used in adults, adolescents and children from 4 years of age.
Danish: Anvendelse - Briviact anvendes hos voksne, unge og børn over 4 år.
English: Brivaracetam film-coated tablets contain lactose.
Danish: Brivaracetam filmovertrukne tabletter indeholder lactose.
English: A long-term, uncontrolled, open-label safety study included children (from 4 years to less than 16 years) who continued treatment after completing the PK study (see section 5.2) and children directly enrolled into the safety study.
Danish: Et længerevarende, ukontrolleret åbent sikkerhedsstudie inkluderede børn (fra 4 år til under 16 år), som fortsatte behandling efter fuldførelse af farmakokinetik-studiet (se pkt.
English: Any unused medicinal product, neat or diluted, or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel, ufortyndet eller fortyndet, samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Only clear solution free from particles and discoloration should be used.
Danish: - Kun klar opløsning, som er fri for partikler og som ikke er misfarvet, må anvendes.
English: Do not take Briviact if: - you are allergic to brivaracetam, other pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Briviact, hvis: - De er allergisk over for brivaracetam, andre pyrrolidonderivater eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: - Spørg på apoteket, hvordan De skal bortskaffe medicinrester.
English: In a pharmacokinetic study with a 3-week evaluation period and weekly fixed 3-step up-titration using the brivaracetam oral solution, 99 subjects aged 1 month to <16 years were evaluated.
Danish: I et farmakokinetisk studie med en evalueringsperiode på 3 uger og fast ugentlig optitrering i 3 trin ved brug af den orale opløsning af brivaracetam evalueredes 99 forsøgspersoner i en alder fra 1 måned til < 16 år.
English: Effects of brivaracetam on other medicinal products Brivaracetam given 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by CYP3A4).
Danish: Brivaracetam 50 mg/dag eller 150 mg/dag påvirkede ikke AUC for midazolam (metaboliseres af CYP3A4).
English: All doses were adjusted by body weight, and did not exceed a maximum of 50 mg/day, 100 mg/day, and 200 mg/day.
Danish: Alle doser blev justeret efter kropsvægt og oversteg ikke en maksimal dosis på 50 mg/dag, 100 mg/dag, og 200 mg/dag.
English: Children (≥4 years) and adolescents ≥50 kg Administered in 2 equally divided doses
Danish: Børn (≥ 4 år) og unge ≥ 50 kg Administreres opdelt i to lige store doser
English: In a study in elderly subjects (65 to79 years old; with creatinine clearance 53 to 98 ml/min/1.73 m²) receiving brivaracetam 400 mg/day in bid administration, the plasma half-life of brivaracetam was 7.9 hours and 9.3 hours in the 65 to 75 and >75 years groups, respectively.
Danish: I et studie med ældre forsøgspersoner (65 til 79 år; med kreatininclearance på 53 til 98 ml/min/1,73 m2), som fik brivaracetam 400 mg/dag administreret som to administrationer, var brivaracetams plasmahalveringstid 7,9 timer for 65 til 75 års gruppen og 9,3 timer for >75 års gruppen.
English: In a pharmacokinetic and pharmacodynamic interaction study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy subjects, there was no pharmacokinetic interaction but brivaracetam approximately doubled the effect of alcohol on psychomotor function, attention and memory.
Danish: I et farmakokinetisk og farmakodynamisk interaktionsstudie sås der ingen farmakokinetisk interaktion mellem en enkeltdosis brivaracetam 200 mg og kontinuerlig infusion af ethanol 0,6 g/l hos raske forsøgspersoner, men brivaracetam omtrent fordoblede effekten af alkohol på psykomotoriske funktioner, opmærksomhed og hukommelse.
English: Risk related to brivaracetam
Danish: Risici forbundet med brivaracetam
English: The 5 ml oral syringe has 2 overlapping graduations: in steps of 0.25 ml and in steps of 0.1 ml.
Danish: 5 ml oral sprøjte har 2 overlappende gradueringer: med trin på 0,25 ml og trin på 0,1 ml.
English: In vitro, Brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose.
Danish: In vitro hæmmer Brivaracetam OAT3 med en halv maksimal inhiberende koncentration, som er 42 gange højere end Cmax ved den højeste kliniske dosis.
English: Briviact contains sodium
Danish: Briviact indeholder natrium
English: Further seizure frequency reduction is obtained by increasing the dose to 100 mg/day and reaches a plateau at 200 mg/day.
Danish: Yderligere reduktion i antallet af anfald opnås ved at øge dosis til 100 mg/dag, og en udjævning nås ved 200 mg/dag.
English: Somnolence and dizziness have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam.
Danish: Der er rapporteret om døsighed og svimmelhed hos én rask forsøgsperson, som tog én 1.400 mg brivaracetam enkeltdosis.
English: Briviact may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) solution for injection or lactated Ringer's solution.
Danish: Briviact kan fortyndes med følgende opløsninger: natriumchlorid 9 mg/ml (0,9 %), glucose 50 mg/ml (5 %) injektionsvæske, opløsning eller Ringer lactat opløsning.
English: The 10 ml oral syringe has only one graduation in steps of 0.25 ml.
Danish: 10 ml oral sprøjte har kun én graduering med trin på 0,25 ml.
English: Brivaracetam did not affect male or female fertility and has demonstrated no teratogenic potential in either rat or rabbit.
Danish: Brivaracetam viste ikke teratogent potentiale og påvirkede ikke fertiliteten hos hverken rotter eller kaniner af begge køn.
English: In controlled studies, the carbamazepine epoxide plasma concentration increased by a mean of 37 %, 62 % and 98 % with little variability at brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day respectively.
Danish: I kontrollerede studier steg plasmakoncentrationen af carbamazepinepoxid gennemsnitligt med 37 %, 62 % og 98 % med lav variabilitet ved brivaracetamdoser på henholdsvis 50 mg/dag, 100 mg/dag og 200 mg/dag.
English: There are two ways in which you can choose to drink the medicine: - empty the contents of the syringe into water (or juice) by pushing the plunger to the bottom of the oral syringe (figure 11) - you will then need to drink all of the water (add just enough to make it easy to drink) or - drink the solution directly from the oral syringe without water - drink the whole contents of the syringe (figure 12).
Danish: De kan vælge mellem to måder at drikke lægemidlet på: - Tøm indholdet af sprøjten ud i vand (eller juice) ved at presse stemplet i den orale sprøjte helt i bund (figur 11).
English: Potential interactions between brivaracetam (50 mg/day to 200 mg/day) and other AEDs were investigated in a pooled analysis of plasma drug concentrations from all phase 2-3 studies in a population pharmacokinetic analysis of placebo-controlled phase 2-3 studies, and in dedicated drugdrug interaction studies (for the following AEDs: carbamazepine, lamotrigine, phenytoin and topiramate).
Danish: Potentielle interaktioner mellem brivaracetam (50 mg/dag til 200 mg/dag) og andre antiepileptika blev undersøgt i en samlet analyse af lægemiddelkoncentrationer i plasma fra alle fase 2-3 studier i en farmakokinetisk populationsanalyse af placebokontrollerede fase 2-3 studier og i et specifikt lægemiddelinteraktionsstudie (for følgende antiepileptika: carbamazepin, lamotrigin, phenytoin og topiramat).
English: At the end of the evaluation period, subjects may have been eligible for entry into a long-term follow-up study continuing on their last received dose (see section 4.8).
Danish: I slutningen af evalueringsperioden kunne forsøgspersoner være kvalificerede til at indgå i et langtids-opfølgningsstudie og fortsætte behandling med den sidst modtagne dosis (se pkt.
English: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Danish: Fremstiller UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgien
English: In juvenile dogs, the brivaracetam-induced changes at the exposure level 6- fold the clinical AUC were similar to those observed in adult animals.
Danish: Hos juvenile hunde svarede de brivaracetam-inducerede ændringer ved et eksponeringsniveau på 6 gange den kliniske AUC til dem, der blev observeret hos voksne dyr.
English: Brivaracetam solution for injection/infusion is physically compatible and chemically stable when mixed with the following diluents
Danish: Brivaracetam injektions-/infusionsvæske, opløsning er fundet fysisk kompatibelt og kemisk stabilt, når det blandes med følgende fortyndere
English: Briviact oral solution is provided with a 5 ml and a 10 ml oral dosing syringe with their adaptor.
Danish: Briviact oral opløsning leveres med en 5 ml og en 10 ml oral doseringssprøjte med adapter.
English: 50 mg/day 100 mg/day 200 mg/day
Danish: 50 mg/dag 100 mg/dag 200 mg/dag
English: Briviact contains the active substance brivaracetam.
Danish: Briviact indeholder det aktive stof brivaracetam.
English: Brivaracetam is not recommended for use in monotherapy.
Danish: Brivaracetam anbefales ikke som monoterapi.
English: Other sources of information
Danish: Yderligere oplysninger
English: Additional graduations at 0.25 ml and 0.75 ml starting at 0.25 ml up to 5 ml are shown.
Danish: Yderligere streger vises ved 0,25 ml og 0,75 ml fra 0,25 ml op til 5 ml.
English: There are limited clinical data on the use of brivaracetam in patients with pre-existing hepatic impairment.
Danish: Der foreligger begrænsede kliniske data om brug af brivaracetam til patienter med eksisterende leverfunktionsnedsættelse.
English: In children aged 4 years and older, partial onset seizures have a similar clinical expression to those in adolescents and adults.
Danish: Hos børn på 4 år eller derover svarer de kliniske tegn på partielle anfald til dem, der ses hos unge og voksne.
English: No clinical data are available in paediatric patients with hepatic impairment.
Danish: Ingen kliniske data er tilgængelige for pædiatriske patienter med nedsat leverfunktion.
English: In the short-term clinical studies of brivaracetam in epilepsy patients, there were no cases of completed suicide and suicide attempt, however both have been reported in open-label extension studies(see section 4.4).
Danish: I de korterevarende kliniske studier med brivaracetam hos epilepsipatienter var der ingen tilfælde med fuldbyrdet selvmord og selvmordsforsøg, dog blev både selvmord og selvmordsforsøg rapporteret i åbne forlængelsesstudier (se pkt.
English: Take the daily dose in two equal divided doses - one in the morning and one in the evening at about the same time each day.
Danish: Tag den daglige dosis fordelt på to lige store doser, en gang om morgenen og en gang om aftenen på omtrent det samme tidspunkt hver dag.
English: The steady-state plasma clearance of brivaracetam was similar (0.76 ml/min/kg) to young healthy male subjects (0.83 ml/min/kg).
Danish: Brivaracetams steady-state plasmaclearance (0,76 ml/min/kg) svarende til den, som sås hos unge raske mandlige forsøgspersoner (0,83 ml/min/kg) (se pkt.
English: 1 mg/kg/day (or 2 mg/kg/day)*
Danish: 1 mg/kg/dag (eller 2 mg/kg/dag)*
English: In the table below, adverse reactions, which were identified based on review of the three placebocontrolled, fixed-dose studies safety database in subjects ≥ 16 years of age, are listed by System Organ Class and frequency.
Danish: Bivirkningerne, som blev identificeret efter gennemgang af sikkerhedsdatabasen for de tre placebokontrollerede, fastdosis-studier hos forsøgspersoner ≥ 16 år, er angivet i nedenstående tabel i henhold til systemorganklasse og frekvens.
English: The percentages of patients with at least a 50 % reduction in seizure frequency were 20.3 %, 34.2 %, 39.5 %, and 37.8 % for placebo, 50 mg/day, 100 mg/day, and 200 mg/day, respectively.
Danish: Procentdelen af patienter med mindst 50 % reduktion i frekvensen af anfald var 20,3 %, 34,2 %, 39,5 % og 37,8 % for henholdsvis placebo, 50 mg/dag, 100 mg/dag og 200 mg/dag.
English: No dose adjustment required
Danish: Dosisjustering er ikke nødvendig
English: Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance.
Danish: Samtidig administration af brivaracetam (100 mg/dag) med et oralt kontraceptiv, som indeholdt ethinylestradiol (0,03 mg) og levonorgestrel (0,15 mg), påvirkede ikke de to stoffers farmakokinetik.
English: AUC 19 % ↓ No dose adjustment required
Danish: AUC 19 % ↓ Dosisjustering er ikke nødvendig
English: In a pooled analysis of the three pivotal trials, no differences in efficacy (measured as 50 % responder rate) was observed within the dose range of 50 mg/day to 200 mg/day when brivaracetam is combined with inducing or non-inducing AEDs.
Danish: I en samlet analyse af de tre pivotale studier blev der ikke set forskelle i virkning (målt som 50 % responsrate) inden for dosisområdet 50 mg/dag til 200 mg/dag, når brivaracetam blev givet samtidig med andre inducerende eller ikke-inducerende antiepileptika.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
English: In clinical studies, brivaracetam was used as adjunctive therapy and when it was used with carbamazepine, it induced a dose-related increase in the concentration of the active metabolite, carbamazepine-epoxide (see section 4.5).
Danish: Brivaracetam blev brugt som tillægsbehandling i kliniske studier, og når det blev brugt sammen med carbamazepin, fremkaldte det en dosisrelateret stigning i koncentrationen af den aktive metabolit carbamazepinepoxid (se pkt.
English: The efficacy and tolerability of brivaracetam in paediatric patients less than 4 years of age have not been established (see section 4.2).
Danish: Brivaracetams virkning og tolerabilitet hos pædiatriske patienter på under 4 år er ikke klarlagt (se pkt.
English: When brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum daily dose) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg), a reduction in estrogen and progestin AUCs of 27 % and 23 %, respectively, was observed without impact on suppression of ovulation.
Danish: Når brivaracetamdoser på 400 mg/dag (to gange den anbefalede daglige maksimumdosis) blev administreret samtidig med et oralt kontraceptiv, som indeholdt ethinylestradiol (0,03 mg) og levonorgestrel (0,15 mg), blev der observeret en reduktion på 27 % og 23 % i AUC for henholdsvis østrogen og progestin uden påvirkning af suppression af ovulationen.
English: Allée de la Recherche 60 B-1070 Brussels Belgium
Danish: Allée de la Recherche 60 B-1070 Bryssel Belgien
English: AUC 21 % ↓ No dose adjustment required
Danish: AUC 21 % ↓ Dosisjustering er ikke nødvendig
English: The adverse reactions most frequently resulting in discontinuation of brivaracetam therapy were dizziness (0.8 %) and convulsion (0.8 %).
Danish: De bivirkninger, som hyppigst resulterede i seponering af behandlingen med brivaracetam, var svimmelhed (0,8 %) og krampe (0,8 %).
English: An additional adverse reaction reported in children was psychomotor hyperactivity
Danish: En yderligere bivirkning rapporteret hos børn var psykomotorisk hyperaktivitet (4,7 %).
English: - Intravenous infusion: brivaracetam may be diluted in a compatible diluent and administered as a 15-minute intravenous infusion (see section 6.6).
Danish: - Intravenøs infusion: brivaracetam kan fortyndes i en kompatibel fortyndingsvæske og administreres som intravenøs infusion over 15 minutter (se pkt.
English: • Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) filmcoated tablets in PVC/PCTFE - Aluminium blisters
Danish: • Pakninger med 14, 56 filmovertrukne tabletter og i multipakninger med 168 (3 pakninger a 56) filmovertrukne tabletter i PVC/PCTFE - Aluminium blister
English: AUC 20% ↑
Danish: Ingen a AUC 20 % ↑ a Cmax 20 % ↑
English: • Packs of 14 x 1 and 100 x 1 film-coated tablet in PVC/PCTFE - Aluminium blisters
Danish: • Pakninger med 14 x 1 og 100 x 1 filmovertrukken tablet i PVC/PCTFE - Aluminium blister
English: The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
Danish: Den orale opløsning indeholder methylparahydroxybenzoate (E 218), der kan give allergiske reaktioner (kan optræde efter behandlingen).
English: Your doctor will work out the right daily dose for you.
Danish: Lægen vil bestemme den korrekte dosis for Dem.
English: Nausea, vomiting, constipation
Danish: Kvalme, opkastning, konstipation
English: Brivaracetam may also be initiated at 2 mg/kg/day based on physician assessment of need for seizure control.
Danish: Brivaracetam kan også startes ved 2 mg/kg/dag baseret på lægens vurdering af behovet for kontrol af krampeanfald.