FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with brivaracetam in one or more subsets of the paediatric population in epilepsy with partial onset seizures.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med brivaracetam i en eller flere undergrupper af den pædiatriske population ved epilepsi med partielle anfald.
English: Brivaracetam is weakly bound (≤ 20 %) to plasma proteins.
Danish: Brivaracetam bindes svagt (≤20 %) til plasmaproteiner.
English: The medicine is injected slowly into your vein or given as an infusion (drip) over 15 minutes.
Danish: Lægemidlet injiceres langsomt i venen eller gives som en infusion (drop) over 15 minutter.
English: However, as a high proportion of subjects (26%) discontinued from the open-label studies due to lack of efficacy, a selection bias may have occurred, as the subjects who stayed in the study responded better than those who have terminated prematurely.
Danish: Men da en stor del af forsøgspersonerne (26 %) udgik fra de åbne studier på grund af manglende virkning, kan der være opstået et udvælgelsesbias, idet forsøgspersonerne, som blev i studiet, responderede bedre end dem, som havde afsluttet studiet før tid.
English: Somnolence and fatigue (8.2 %) were reported at a higher incidence with increasing dose.
Danish: Døsighed og træthed (8,2 %) blev rapporteret hyppigere i takt med stigende dosis.
English: (Omitted from cartons of 14 film-coated tablets)
Danish: (Udelades på kartoner med 14 filmovertrukne tabletter)
English: Briviact is a long term treatment - keep taking Briviact until your doctor tells you to stop.
Danish: Briviact er til langtidsbehandling - fortsæt med at tage Briviact, indtil lægen siger, at De skal stoppe behandlingen.
English: Recommended maintenance dose
Danish: Anbefalet vedligeholdelsesdosis
English: - These effects are more likely at the start of the treatment or after a dose increase.
Danish: - Disse symptomer er mest almindelige i starten af behandlingen og efter øgning af dosis.
English: Excipients which may cause intolerance
Danish: Hjælpestoffer der kan forårsage intolerans
English: Patients had a mean duration of epilepsy of approximately 23 years.
Danish: Patienterne havde en gennemsnitlig epilepsivarighed på 23 år.
English: Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of brivaracetam on their ability to perform such activities.
Danish: Patienter skal rådes til at udvise forsigtighed ved kørsel eller betjening af potentielt farlige maskiner, indtil de er fortrolige med brivaracetams indvirkning på deres evne til at udføre sådanne aktiviteter.
English: There is insufficient data to determine the clinical significance.
Danish: Der er ikke tilstrækkelige data til at bestemme den kliniske betydning.
English: - Briviact may be diluted before it is injected by your doctor or nurse.
Danish: - Briviact kan fortyndes, før det injiceres af lægen eller sygeplejersken.
English: The safety profile in elderly patients appears to be similar to that observed in younger adult patients.
Danish: Sikkerhedsprofilen hos ældre patienter syntes at svare til den, som er observeret hos yngre voksne patienter.
English: See also section 4.8, paediatric data.
Danish: 4.8, pædiatriske data.
English: Discontinuation of anti-epileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus.
Danish: Seponering af behandling med antiepileptika kan medføre forværring af sygdommen, hvilket kan være skadelig for moderen og fosteret.
English: Brivaracetam is rapidly and completely absorbed after oral administration and the absolute bioavailablity is approximately 100 %.
Danish: Brivaracetam absorberes hurtig og fuldstændigt efter oral administration og den absolutte biotilgængelighed er ca. 100 %.
English: It is not recommended to take Briviact if you are pregnant or breast-feeding, as the effects of Briviact on pregnancy and the unborn baby or the new-born child are not known.
Danish: Det anbefales ikke at tage Briviact, hvis De er gravid eller ammer, da virkningen af Briviact på graviditeten og det ufødte eller nyfødte barn ikke er kendt.
English: A 40 % decrease in steady-state plasma concentration has been estimated across a body weight range from 46 kg to 115 kg.
Danish: Der er vist et fald på 40 % i steady-state plasmakoncentrationen ved kropsvægt, som rangerede fra 46 kg til 115 kg.
English: The EC50 (brivaracetam plasma concentration corresponding to 50 % of the maximum effect) was estimated to be 0.57 mg/L.
Danish: EC50 (brivaracetam plasmakoncentrationer svarende til 50 % af den maksimale virkning) blev anslået til at være 0,57 mg/l.
English: Limited data are available on neurodevelopment in children <4 years of age.
Danish: Der findes kun begrænsede data vedrørende nervesystemets udvikling hos børn < 4 år.
English: Four of these subjects had decreased neutrophil counts at baseline, and experienced additional decrease in neutrophil counts after initiation of brivaracetam treatment.
Danish: Fire af disse forsøgspersoner havde nedsat neutrofiltal ved baseline og oplevede yderligere fald i neutrofiltallet efter initiering af behandlingen med brivaracetam.
English: Study N01358
Danish: Studie N01358
English: Children and adolescents weighing less than 50 kg - Your doctor may prescribe the injection only for a few days if you cannot take your medicine by mouth.
Danish: Børn og unge, som vejer under 50 kg - Din læge vil muligvis kun ordinere injektion nogle få dage, hvis du ikke kan tage medicinen gennem munden.
English: There is insufficient data to determine the clinical significance of this effect in pregnancy.
Danish: Der er ikke tilstrækkelige data til at bestemme den kliniske betydning af denne virkning på graviditeten.
English: Children Briviact is not recommended for use in children under 4 years of age.
Danish: Børn Briviact er ikke beregnet til anvendelse hos børn under 4 år.
English: Open-label extension studies
Danish: Åbne forlængelsesstudier
English: Briviact with alcohol - Combining this medicine with alcohol is not recommended.
Danish: Brug af Briviact sammen med alkohol - Det er ikke tilrådeligt at kombinere dette lægemiddel med alkohol.
English: Volume per administration (ml) = [weight (kg) x daily dose (mg/kg/day) ] x 0.05
Danish: Volumen per administration (ml) = [vægt (kg) x daglig dosis (mg/kg/dag) ] x 0,05
English: You have been given this medicine to lower the number of fits (seizures) you have.
Danish: - De har fået dette lægemiddel for at nedbringe antallet af kramper (anfald).
English: Due to its lipophylicity (Log P) brivaracetam has high cell membrane permeability.
Danish: På grund af dets lipofilicitet (Log P) har brivaracetam en høj cellemembranpermeabititet.
English: Brivaracetam bolus injection or intravenous infusion has not been studied in acute conditions; e.g. status epilepticus and is therefore not recommended for such conditions.
Danish: Brivaracetam bolusinjektion eller intravenøs injektion er ikke blevet undersøgt ved akutte tilstande, f.eks. status epilepticus, og anbefales derfor ikke til sådanne tilstande.
English: 50 % Responder rate
Danish: 50 % responsrate
English: If you are on a low sodium diet, you need to take this into account.
Danish: Hvis De er på natrium- eller saltfattig diæt, skal De tage hensyn hertil.
English: Study enrollment criteria required that patients have uncontrolled POS despite treatment with either 1 or 2 concomitant AEDs.
Danish: Studieinklusionskriterierne krævede, at patienterne havde ukontrollerede POS uanset, om de samtidig fik behandling med 1 eller 2 antiepileptika.
English: Your doctor will work out the right dose for you, depending on your weight.
Danish: Deres læge vil bestemme den rette dosis for Dem afhængig af Deres vægt.
English: Calendar days: Mon., Tue.,Wed., Thu., Fri., Sat., Sun.
Danish: ANDET Kalenderdage: Man., Tirs., Ons., Tors., Fre., Lør., Søn.
English: - When you start taking this medicine you will take Briviact orally (as tablets or an oral solution) or be given it as an injection or infusion.
Danish: - Når De starter behandling med dette lægemiddel, vil De tage Briviact gennem munden (som tabletter eller oral opløsning), eller De vil få det som en injektion/infusion.
English: Currently available data are described in section 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Binding to SV2A is believed to be the primary mechanism for brivaracetam anticonvulsant activity.
Danish: Binding til SV2A menes at være den primære mekanisme til brivaracetams antiepileptiske aktivitet.
English: The primary endpoints in the phase 3 studies were the percent reduction in POS frequency over placebo and the 50 % responder rate based on 50 % reduction in POS frequency from baseline.
Danish: De primære endepunkter i fase 3 studierne var den procentvise reduktion i frekvensen af POS i forhold til placebo, og 50 % responsraten baseret på 50 % reduktion i frekvensen af POS fra baseline.
English: Effects of other agents on the pharmacokinetics of brivaracetam In vitro data suggest that brivaracetam has a low interaction potential.
Danish: Virkning af andre lægemidler på brivaracetams farmakokinetik In vitro-data tyder på, at brivaracetam har et lavt interaktionspotentiale.
English: The majority of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of study drug.
Danish: Størstedelen af hændelser var af mild eller moderat intensitet, ikke alvorlige og medførte ikke seponering af studiemedicin.
English: Prescribers should consider adjusting the brivaracetam dose in patients starting or ending treatment with rifampicin.
Danish: Den ordinerende læge bør overveje at justere dosis af brivaracetam hos patienter, som initierer eller ophører behandling med rifampicin.
English: However, toxicological data accumulated on brivaracetam and on a structurally-related compound indicate that the dog liver changes have developed through mechanisms not relevant for humans.
Danish: Toksikologiske data indsamlet for brivaracetam og et strukturelt relateret stof indikerer dog, at leverforandringerne hos hunden er udviklet gennem mekanismer, som ikke er relevante for mennesker.
English: Brivaracetam is eliminated primarily by metabolism and by excretion in the urine.
Danish: Brivaracetam elimineres primært ved metabolisme og ved udskillelse via urinen.
English: More details are provided below the table.
Danish: Yderligere oplysninger findes under tabellen.
English: The three pivotal double-blind placebo-controlled studies included 38 elderly patients aged between 65 and 80 years.
Danish: De tre pivotale, dobbeltblinde, placebokontrollerede studier inkluderede 38 ældre patienter i alderen 65 år til 80 år.
English: The types of adverse reactions reported during the first 7 days of treatment were similar to those reported for the overall treatment period.
Danish: Typen af bivirkninger, som blev rapporteret i løbet af de første 7 behandlingsdage svarende til dem, som blev rapporteret i den samlede behandlingsperiode.
English: Other strong enzyme inducers (such as St John´s wort (Hypericum perforatum)) may also decrease the systemic exposure of brivaracetam.
Danish: Andre stærke enzyminducere (såsom prikbladet perikum (Hypericum perforatum)) kan også nedsætte den systemiske eksponering for brivaracetam.
English: Opening date (Only for outer carton)
Danish: Dato for første åbning (Kun for ydre karton)
English: None of the 6 cases of neutropenia were severe, required any specific treatment or led to discontinuation of brivaracetam and none had associated infections.
Danish: Ingen af de 6 tilfælde af neutropeni var alvorlige, krævede særlig behandling eller førte til seponering af brivaracetam, og ingen af patienterne fik ledsagende infektioner.
English: The maximum dose should not exceed 3 mg/kg/day.
Danish: Den maksimale dosis bør ikke overstige 3 mg/kg/dag.
English: The total plasma clearance in patients was estimated to 3.6 L/h.
Danish: Den totale plasmaclearance hos patienter blev anslået til at være 3,6 l/t.
English: Brivaracetam did not show any dependence potential in rats.
Danish: Brivaracetam viste ikke afhængighedspotentiale hos rotter.
English: The table below provides examples of volumes of oral solution per intake depending on prescribed dose and body weight.
Danish: Nedenstående tabel viser eksempler på mængder af oral opløsning per indtagelse afhængigt af den ordinerede dosis og kropsvægt.
English: Component of a multipack, can't be sold separately.
Danish: Del af multipakning, sælges ikke separat.
English: n = randomised patients who received at least 1 dose of study medication ~ Dose not studied
Danish: n = randomiserede patienter, som fik mindst 1 dosis af studiemedicinen
English: Common: may affect up to 1 in 10 people - restlessness and hyperactivity (psychomotor hyperactivity)
Danish: Almindelig: kan påvirke op til 1 ud af 10 personer - rastløshed og hyperaktivitet (psykomotorisk hyperaktivitet)
English: The oral solution contains sorbitol (E420).
Danish: Den orale opløsning indeholder sorbitol (E 420).
English: Population pharmacokinetics modeling indicated that the dose of 2.0 mg/kg twice a day provides the same steady-state average plasma concentration as in adults receiving 100 mg twice daily.
Danish: Farmakokinetisk populationsmodellering viste, at en dosis på 2,0 mg/kg to gange dagligt giver samme gennemsnitlige steady-state plasmakoncentrationer som hos voksne, der får 100 mg to gange dagligt.
English: There was generally no change in the concentration-time profiles of the endogenous markers estradiol, progesterone, luteinizing hormone (LH), follicle stimulating hormone (FSH), and sex hormone binding globulin (SHBG).
Danish: Der var generelt ingen ændring i profilerne for koncentration-tid af de endogene markører estradiol, progesteron, luteiniserende hormon (LH), follikelstimulerende hormon (FSH) og kønshormonbindende globulin (SHBG).
English: Pharmacokinetics in special patient groups
Danish: Farmakokinetiske forhold hos specielle patientgrupper
English: No child received a dose greater than 200 mg/day.
Danish: Ingen børn fik en dosis på mere end 200 mg/dag.
English: In particular, tell your doctor if you are taking any of the following medicines - this is because your doctor may need to adjust your Briviact dose: - Rifampicin - a medicine used to treat bacterial infections.
Danish: Fortæl især altid lægen, hvis De tager følgende lægemidler, da lægen muligvis skal justere Deres dosis af Briviact: - Rifampicin - et lægemiddel, som anvendes til behandling af infektioner, som skyldes bakterier.
English: All packs are available in PVC/PCTFE - Aluminium blisters.
Danish: Alle pakninger fås i PVC/PCTFE - Aluminium blister.
English: Although data are limited, the efficacy was comparable to younger subjects.
Danish: Selvom data er begrænsede, svarede virkningen til den, som kendes fra yngre forsøgspersoner.
English: No additional safety or tolerability concerns were observed.
Danish: Der blev ikke observeret andre sikkerheds- eller tolerabilitetsproblemer.
English: Brivaracetam has minor or moderate influence on the ability to drive and use machines.
Danish: Brivaracetam påvirker i mindre grad eller i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: A small number of people being treated with anti-epileptic medicines such as Briviact have had thoughts of harming or killing themselves.
Danish: En lille del af de personer, der bliver behandlet med epilepsimedicin, som for eksempel Briviact, har haft tanker om at gøre skade på sig selv eller selvmordstanker.
English: It is unknown whether brivaracetam is excreted in human breast milk.
Danish: Det vides ikke, om brivaracetam udskilles i human mælk.
English: There were no adverse effects in any of the standard developmental or maturation endpoints.
Danish: Der sås ikke uønskede virkninger på standardudvikling og modningsmålepunkter.
English: Table 2: Key Efficacy Outcomes for Partial Onset Seizure Frequency per 28 Days Study
Danish: Tabel 2: Væsentlige virkningsresultater for partielle anfald pr. 28 dage Brivaracetam
English: The volume of distribution is 0.5 L/kg, a value close to that of the total body water.
Danish: Fordelingsvolumen er 0,5 l/kg, en værdi, der ligger tæt på kroppens totale vandindhold.
English: Patients with an improvement in percent reduction in baseline POS frequency are shown in the 4 right-most categories.
Danish: Patienter med en forbedring i den procentvise reduktion i frekvensen af POS ved baseline er vist i de 4 koloner længst til højre.
English: There is no experience with twice daily intravenous administration of brivaracetam for a period longer than 4 days.
Danish: Der er ingen erfaring med intravenøs administration af brivaracetam to gange dagligt i mere end 4 dage.
English: The hydrolysis of the amide moiety leading to the carboxylic acid metabolite (34 % of the dose in urine) is supported by hepatic and extra-hepatic amidase.
Danish: Hydrolysen af amid-delen som danner carboxylsyre-metabolitten (34 % af dosis i urinen) understøttes af hepatisk og ekstrahepatisk amidase.
English: Due to possible differences in individual sensitivity some patients might experience somnolence, dizziness, and other central nervous system (CNS) related symptoms.
Danish: Da den individuelle følsomhed kan være forskellig, kan nogle patienter opleve døsighed, svimmelhed eller andre CNS-relaterede symptomer.
English: This helps to stop your fits coming back or getting worse.
Danish: Dette forhindrer, at kramperne vender tilbage eller forværres.
English: If your doctor asks you to stop taking this medicine they will lower your dose gradually.
Danish: - Hvis lægen beslutter, at behandlingen med dette lægemiddel skal stoppe, vil han/hun gradvist nedtrappe dosis.
English: (not for packsizes 14 x1 and 100 x 1 film-coated tablet)
Danish: (ikke for pakningsstørrelserne 14 x 1 og 100 x 1 filmovertrukken tablet)
English: - Take the oral syringe out of the adaptor (figure 10).
Danish: - Tag den orale sprøjte ud af adapteren (figur 10).
English: In patients who were followed up in the open-label extension studies for up to 8 years, the safety profile was similar to that observed in the short-term, placebo-controlled studies.
Danish: Hos patienter, som blev fulgt i op til 8 år i åbne forlængelsesstudier, svarede sikkerhedsprofilen til den, som blev observeret i de korterevarende, placebokontrollerede studier.
English: How to take Briviact oral solution - You can take Briviact oral solution on its own, or dilute it in water or juice shortly before swallowing.
Danish: Sådan skal De tage Briviact oral opløsning - De kan tage Briviact oral opløsning alene eller De kan opløse det i vand eller juice umiddelbart før indtagelse.
English: There is no specific antidote for overdose with brivaracetam.
Danish: Der findes ingen specifik antidot mod overdosering med brivaracetam.
English: The effect of the interactions on the plasma concentration is summarised in table 1 (increase is indicated as “↑” and decrease as “↓”, area under the plasma concentration versus time curve as “AUC”, maximum observed concentration as Cmax).
Danish: Interaktionernes virkning på plasmakoncentrationerne er opsummeret i tabel 1 (stigning er angivet som “↑” og fald som “↓”, kurven for areal under plasmakoncentrationen versus tid er angivet som ”AUC”, og den maksimale observerede koncentration er angivet som ”Cmax”).
English: Brivaracetam 200mg/day may increase plasma concentrations of medicinal products transported by OAT3.
Danish: Briviracetam 200 mg/dag kan øge plasmakoncentrationerne af lægemidler, som transporteres af OAT3.
English: - Put the adaptor into the top of the bottle (figure 3).
Danish: - Sæt adapteren fast på toppen af flasken (figur 3).
English: Physicians should discuss family planning and contraception with women of childbearing potential taking brivaracetam (see Pregnancy).
Danish: Læger skal drøfte familiestiftelse og prævention med kvinder i den fødedygtige alder, som tager brivaracetam (se ”Graviditet”).
English: - St John's wort (also known as Hypericum perforatum) - a herbal medicine used to treat depression and anxiety as well as other conditions.
Danish: - Prikbladet perikon (også kendt som Hypericum perforatum), som er et naturlægemiddel, som anvendes til behandling af depression og angst samt andre tilstande.
English: - Pull the plunger down to the millilitre (ml) dose marker on the oral syringe prescribed by your doctor (figure 8).
Danish: - Træk stemplet ned til den milliliter (ml) doseringsstreg på den orale sprøjte, som lægen har ordineret (figur 8).
English: Less than 1 % of the dose is excreted in faeces and less than 10 % of brivaracetam is excreted unchanged in urine.
Danish: Mindre end 1 % af dosis udskilles i fæces og mindre end 10 % af brivaracetam udskilles uomdannet i urinen.
English: Patients (and caregivers of patients) should be advised to seek medical advice should any signs of suicidal ideation or behaviour emerge.
Danish: Patienter (og plejepersonale) bør rådes til straks at kontakte en læge, hvis der opstår tegn på selvmordstanker eller -adfærd.
English: Exposure to brivaracetam was increased in adult patients with chronic liver disease.
Danish: Eksponering for brivaracetam var øget hos voksne patienter med kronisk leversygdom.
English: The physician should prescribe the most appropriate formulation and strength according to weight and dose.
Danish: Lægen skal ordinere den mest hensigstsmæssige formulering og styrke baseret på vægt og dosis.
English: Dose taken twice daily for children from 4 years of age weighing less than 50 kg.
Danish: Dosis som tages to gange dagligt for børn på 4 år og derover, som vejer under 50 kg.
English: Follow these steps each time you take Briviact: - Put the oral syringe into the adaptor opening (figure 4).
Danish: Følg disse trin hver gang De tager Briviact: - Sæt den orale sprøjte ind i adapteråbningen (figur 4).
English: OUTER CARTON / BOTTLE
Danish: YDRE KARTON/FLASKE
English: Brivaracetam film-coated tablets, oral solution and solution for intravenous injection show the same AUC, while the maximum plasma concentration is slightly higher after intravenous administration.
Danish: Brivaracetam filmovertrukne tabletter, oral opløsning og injektionsvæske, opløsning viser samme AUC, mens den maksimale plasmakoncentration er lidt højere efter intravenøs administration.
English: Figure 1 shows the percentage of patients (excluding patients with concomitant levetiracetam) by category of reduction from baseline in POS frequency per 28 days in all 3 studies.
Danish: Figur 1 viser procentdelen af patienter (eksklusive patienter, som samtidig fik levetiracetam) i alle 3 studier kategoriseret efter reduktion i POS pr. 28 dage fra baseline.
English: A decision should be made whether to discontinue breastfeeding or to discontinue brivaracetam, taking into account the benefit of the medicinal product to the mother.
Danish: Det skal besluttes, om amning eller behandling med brivaracetam skal ophøre, idet der tages højde for de terapeutiske fordele for moderen.
English: - Keep the bottle, the oral syringe, and the leaflet in the carton.
Danish: - Opbevar flasken, den orale sprøjte og indlægssedlen i kartonen.
English: - If you weigh 20 kg or more, your doctor will recommend the use of the 5 ml oral syringe or the
Danish: - Hvis du vejer 20 kg eller derover, vil lægen anbefale brug af den orale 5 ml sprøjte eller orale 10
English: Check with your doctor which one you should use.
Danish: Spørg lægen, hvilken du skal bruge.
English: - Intravenous bolus: brivaracetam may be administered as an intravenous bolus without dilution.
Danish: - Intravenøs bolus: brivaracetam kan administreres som intravenøs bolus uden fortynding.
English: Two oral syringes will be provided in the carton.
Danish: To orale sprøjter leveres i kartonen.