FrancophonIA/ELRC3.0 huggingface dataset:
English: - Then take your next dose at the time you would normally take it. - Do not take a double dose to make up for a forgotten dose.
Danish: - De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Sorbitol liquid
Danish: Sorbitol, flydende
English: One full 5 ml oral dosing syringe corresponds to 50 mg of brivaracetam.
Danish: En fuld 5 ml oral doseringssprøjte svarer til 50 mg brivaracetam.
English: The discontinuation rate due to adverse reactions was 3.5 %, 3.4 % and 4.0 % for patients randomized to brivaracetam at respectively the dose of 50 mg/day, 100 mg/day and 200 mg/day and 1.7% for patients randomized to placebo.
Danish: Seponeringsraten på grund af bivirkninger var 3,5 %, 3,4 % og 4,0 % for doser på henholdsvis 50 mg/dag, 100 mg/dag og 200 mg/dag for patienter, som var randomiseret til brivaracetam, og 1,7 % for patienter, som var randomiseret til placebo.
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 brivaracetam
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 brivaracetam
English: This medicinal product is for single use only, any unused solution should be discarded.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Lægemidlet er kun til enkeltdosisbrug, ubrugt opløsning skal kasseres.
English: nervous excitement (agitation) - thoughts or attempts of harming or killing yourself: tell your doctor straight away - a decrease in white blood cells (called ‘neutropenia') - shown in blood tests
Danish: - unormal tankegang og/eller manglende realitetssans (psykiske forstyrrelser), aggressivitet, nervøs ophidselse (agitation) - tanker om eller forsøg på selvmord eller selvskade: fortæl det straks til lægen - nedsat antal hvide blodlegemer i blodet (kaldet ”neutropi”) - ses i blodprøver
English: As from the 1 ml graduation mark, each graduation corresponds to 0.25 ml which is 2.5 mg of brivaracetam.
Danish: Fra 1 ml målestregen svarer hver streg til 0,25 ml, hvilket svarer til 2,5 mg brivaracetam.
English: <Justification for not including Braille accepted>
Danish: INFORMATION I BRAILLESKRIFT <Fritaget fra krav om brailleskrift>
English: Oral solution Slightly viscous, clear colourless to yellowish liquid.
Danish: Let tyktflydende, klar, farveløs til gullig væske.
English: Following dilution, brivaracetam solution for injection/infusion was found to be physically compatible and chemically stable when mixed with the diluents listed in the section 6.6 for 24 hours and stored in PVC or polyolefin bags at temperature up to 25°C.
Danish: Efter fortynding blev brivaracetam injektions-/infusionsvæskevæske, opløsning fundet fysisk kompatibelt og kemisk stabilt i 24 timer, når det blev blandet med de fortyndere, der står anført i pkt.
English: Contains sodium acetate (trihydrate), sodium chloride.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder natriumacetat (trihydrat), natriumchlorid.
English: What Briviact contains
Danish: Briviact indeholder:
English: None a based on a study involving the administration of a supratherapeutic dose of 400 mg/day brivaracetam.
Danish: Ingen a baseret på et studie, der omfattede administration af en supraterapeutisk brivaracetamdosis på
English: Sodium acetate (trihydrate) Acetic acid, glacial (for pH-adjustment) Sodium chloride
Danish: Natriumacetat (trihydrat) Krystalliseret citronsyre (til justering af pH) Natriumchlorid
English: Lactose anhydrous Magnesium stearate
Danish: Lactose, vandfri Magnesiumstearat.
English: No dose adjustment is needed in patients with impaired renal function (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: Briviact 10 mg/ml oral solution brivaracetam
Danish: Briviact 10 mg/ml oral opløsning brivaracetam
English: Brivaracetam was evaluated in these patients in a short term openlabel pharmacokinetic study and an ongoing open-label extension study, in 16 subjects from 1 month to <4 years of age (see section 5.2).
Danish: Brivaracetam blev vurderet hos 16 forsøgspersoner i alderen 1 måned til < 4 år i et åbent korterevarende farmakokinetisk studie og et igangværende åbent forlængelsesstudie (se pkt.
English: For children weighing 50 kg or greater the brivaracetam starting dose was 50 mg/day and depending on response and tolerability, the dose was increased up to a maximum of 200 mg/day by weekly increments of 50 mg/day.
Danish: For børn, som vejede 50 kg eller derover, var startdosen af brivaracetam 50 mg/dag, som, afhængigt af respons og tolerabilitet, blev øget op til højst 200 mg/dag med ugentlig forhøjelse på 50 mg/dag.
English: In children and adolescents weighing less than 50 kg, a 1 mg/kg/day starting dose is recommended.
Danish: Hos børn og unge, som vejer under 50 kg, anbefales en startdosis på 1 mg/kg/dag.
English: Briviact 100 mg film-coated tablets Each 100 mg film-coated tablet contains 377 mg lactose.
Danish: Briviact 100 mg filmovertrukne tabletter Hver 100 mg filmovertrukken tablet indeholder 377 mg lactose.
English: Children who directly enrolled received a brivaracetam starting dose of 1 mg/kg/day and depending on response and tolerability, the dose was increased up to 5 mg/kg/day by doubling the dose at weekly intervals.
Danish: Børn, som indgik direkte, fik en startdosis af brivaracetam på 1 mg/kg/dag, som blev øget op til 5 mg/kg/dag, afhængig af respons og tolerabilite,t ved at fordoble dosen med ugentlige intervaller.
English: In children and adolescents weighing 50 kg or greater, a 50 mg/day starting dose is recommended.
Danish: Hos børn og unge, som vejer 50 kg eller derover, anbefales en startdosis på 50 mg/dag.
English: Study N01253
Danish: Studie N01253(1)
English: Briviact 50 mg film-coated tablets Each 50 mg film-coated tablet contains 189 mg lactose.
Danish: Briviact 50 mg filmovertrukne tabletter Hver 50 mg filmovertrukken tablet indeholder 189 mg lactose.
English: Briviact is used together with other medicines for epilepsy.
Danish: Briviact anvendes sammen med andre lægemidler mod epilepsi.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Briviact Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: If you have taken more Briviact than you should, talk to your doctor.
Danish: Hvis De har taget for meget Briviact Kontakt lægen, hvis De har taget mere Briviact, end De skulle.
English: Briviact 75 mg film-coated tablets Each 75 mg film-coated tablet contains 283 mg lactose.
Danish: Briviact 75 mg filmovertrukne tabletter Hver 75 mg filmovertrukken tablet indeholder 283 mg lactose.
English: Neutropenia has been reported in 0.5 % (6/1,099) brivaracetam patients and 0 % (0/459) placebo patients.
Danish: Der blev rapporteret neutropeni hos 0,5 % (6/1.099) af patienterne, som fik brivaracetam, og hos 0 % (0/459) af patienterne, som fik placebo.
English: Multipack: 168 (3 packs of 56) film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 168 (3 pakninger a 56) filmovertrukne tabletter
English: Based on individual patient response and tolerability, the dose may be adjusted in the dose range of 50 mg/day to 200 mg/day.
Danish: Afhængigt af patientens individuelle respons og tolerabilitet kan den daglige dosis justeres inden for dosisområdet 50 mg/dag til 200 mg/dag.
English: From the pooled open-label safety and PK studies in adjunctive therapy, 149 children with POS have received brivaracetam, of whom 116 have been treated for ≥6 months, 107 for ≥12 months, 58 for ≥24 months, and 28 for ≥36 months.
Danish: I alt har 149 børn med POS fået brivaracetam i de åbne sikkerheds- og farmakokinetik-studier som tillægsbehandling, hvoraf 116 er blevet behandlet i ≥ 6 måneder, 107 i ≥ 12 måneder, 58 i ≥ 24 måneder og 28 i ≥ 36 måneder.
English: Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day and 4 mg/kg/day.
Danish: Baseret på patientens individuelle respons, kan dosen justeres inden for det effektive dosisområde på mellem 1 mg/kg/dag og 4 mg/kg/dag.
English: What you need to know before you use Briviact 3.
Danish: Det skal De vide, før De begynder at bruge Briviact
English: Briviact 25 mg film-coated tablets Each 25 mg film-coated tablet contains 94 mg lactose.
Danish: Briviact 25 mg filmovertrukne tabletter Hver 25 mg filmovertrukken tablet indeholder 94 mg lactose.
English: The efficacy of brivaracetam in monotherapy has not been established.
Danish: Virkningen af brivaracetam som monoterapi er ikke klarlagt.
English: Coating - 10 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Danish: Overtræk - 10 mg filmovertrukne tabletter: polyvinylalkohol; titandioxid (E 171); macrogol 3350; talcum.
English: From the pooled open-label safety and PK studies in adjunctive therapy, 149 children have received brivaracetam, of whom 116 have been treated for ≥6 months, 107 for ≥12 months, 58 for ≥24 months, and 28 for ≥36 months.
Danish: I alt har 149 børn fået brivaracetam i de åbne sikkerheds- og farmakokinetik-studier med tillægsbehandling, hvoraf 116 er blevet behandlet i ≥ 6 måneder, 107 i ≥ 12 måneder, 58 i ≥ 24 måneder og 28 i ≥ 36 måneder.
English: Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day and 200 mg/day.
Danish: Baseret på patientens individuelle respons, kan dosen justeres inden for det effektive dosisområde på mellem 50 mg/dag og 200 mg/dag.
English: Metabolism and nutrition disorders
Danish: Ikke almindelig Neutropeni Metabolisme og ernæring Almindelig
English: What Briviact looks like and contents of the pack Briviact 10 mg/ml solution for injection/infusion is a clear, colourless, sterile solution.
Danish: Briviact 10 mg/ml injektions-/infusionsvæske, opløsning er en klar, farveløs, steril opløsning.
English: Suicidal ideation has been reported in 0.3 % (3/1,099) brivaracetam patients and 0.7 % (3/459) placebo patients.
Danish: Der blev rapporteret selvmordstanker hos 0,3 % (3/1.099) af patienterne, som fik brivaracetam og hos 0,7 % (3/459) af patienterne, som fik placebo.
English: - As a child or adolescent weighing less than 50 kg, the maximum dose you will take is 1.5 mg for each kg of bodyweight twice a day.
Danish: - Som barn eller ung, der vejer under 50 kg, er den maksimale dosis 1,5 mg per kg kropsvægt to gange dagligt.
English: Overall, brivaracetam was efficacious for the adjunctive treatment of partial onset seizures in patients 16 years of age and older between 50 mg/day and 200 mg/day.
Danish: Samlet set var brivaracetam i doser på mellem 50 mg/dag og 200 mg/dag effektivt som tillægsbehandling af partielle anfald hos patienter fra 16 år og opefter.
English: Briviact 100 mg are green-grey, oval, film-coated tablets of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Danish: Briviact 100 mg er grøn-grå, ovale, filmovertrukne tabletter, der måler 14,5 mm x 8,1 mm og er præget med ”u100” på den ene side.
English: You will take Briviact together with other medicines for epilepsy.
Danish: De vil tage Briviact sammen med andre lægemidler til behandling af epilepsi.
English: How to take Briviact
Danish: Sådan skal De tage Briviact
English: 50 - 200 mg/day
Danish: Terapeutisk dosisområde 50 - 200 mg/dag
English: (corresponding to 2 mg/kg/intake)
Danish: (svarende til 2 mg/kg/ indtagelse)
English: Briviact 10 mg/ml oral solution
Danish: LÆGEMIDLETS NAVN Briviact 10 mg/ml oral opløsning
English: Brivaracetam is not recommended in end-stage renal disease patients undergoing dialysis due to lack of data.
Danish: På grund af manglende data anbefales brug af brivaracetam ikke til patienter med terminal nyresygdom, som er i dialyse.
English: As a child or adolescent weighing less than 50 kg, the maximum dose you will take is 1.5 mg for each kg of bodyweight twice a day.
Danish: Som barn eller ung, der vejer under 50 kg, er den maksimale dosis 1,5 mg per kg kropsvægt to gange dagligt.
English: What Briviact looks like and contents of the pack Briviact 10 mg are white to off-white, round, film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Danish: Briviact 10 mg er hvide til gråhvide, runde, filmovertrukne tabletter med en diameter på 6,5 mm og er præget med ”u10” på den ene side.
English: 56 film-coated tablets.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 56 filmovertrukne tabletter.
English: Briviact 25 mg are grey, oval, film-coated tablets of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
Danish: Briviact 25 mg er grå, ovale, filmovertrukne tabletter, der måler 8,9 mm x 5,0 mm og er præget med ”u25” på den ene side.
English: 0.1 ml/kg/intake
Danish: 0,1 ml/kg/ indtagelse
English: (corresponding to 1.5 mg/kg/intake)
Danish: (svarende til 1,5 mg/kg/ indtagelse)
English: (corresponding to 1 mg/kg/intake)
Danish: (svarende til 1 mg/kg/ indtagelse)
English: EU/1/15/1073/022
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1073/022
English: One vial of 5 ml contains 50 mg brivaracetam.
Danish: Et hætteglas på 5 ml indeholder 50 mg brivaracetam.
English: Product with particulate matter or discoloration should not be used.
Danish: Lægemiddel med uklarheder og misfarvning må ikke anvendes.
English: Briviact 50 mg are yellow, oval, film-coated tablets of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Danish: Briviact 50 mg er gule, ovale, filmovertrukne tabletter, der måler 11,7 mm x 6,6 mm og er præget med ”u50” på den ene side.
English: Green-grey, oval film-coated tablets with dimensions of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Danish: Grøn-grå, ovale, filmovertrukne tabletter, der måler 14,5 mm x 8,1 mm og er præget med ”u100” på den ene side.
English: Briviact 75 mg are purple, oval, film-coated tablets of 13.0 mm x 7.3 mm and debossed with ‘u75' on one side.
Danish: Briviact 75 mg er lilla, ovale, filmovertrukne tabletter, der måler 13,0 mm x 7,3 mm og er præget med ”u75” på den ene side.
English: Children (from 4 years of age) and adolescents weighing less than 50 kg The recommended starting dose is 1 mg/kg/day.
Danish: Børn (fra 4 år eller derover) og unge, som vejer under 50 kg Den anbefalede startdosis er 1 mg/kg/dag.
English: EU/1/15/1073/021
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1073/021
English: Children (from 4 years of age) and adolescents weighing 50 kg or more The recommended starting dose is 50mg/day.
Danish: Børn (4 år eller derover) og unge, som vejer 50 kg eller derover Den anbefalede startdosis er 50 mg/dag.
English: Other enzyme inducers
Danish: Andre enzyminducere
English: UCB Pharma S.A. (logo)
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN UCB Pharma S.A. (logo)
English: Elderly (65 years of age and above) No dose adjustment is needed in elderly patients (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: Briviact 75 mg film-coated tablets Each film-coated tablet contains 75 mg brivaracetam.
Danish: Briviact 75 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 75 mg brivaracetam.
English: (corresponding to 0.5 mg/kg/intake)
Danish: (svarende til 0,5 mg/kg/ indtagelse)
English: You will use Briviact together with other medicines for epilepsy.
Danish: De vil bruge Briviact sammen med andre lægemidler til behandling af epilepsi.
English: n = 100 n = 99 n = 100
Danish: n=100
English: Briviact 75 mg film-coated tablets
Danish: Briviact 75 mg filmovertrukne tabletter
English: Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Danish: Gule, ovale, filmovertrukne tabletter, der måler 11,7 mm x 6,6 mm og er præget med ”u50” på den ene side.
English: 50 mg/5 ml 10 vials solution for injection/infusion
Danish: Glucose 50 mg/ml (5 %) injektionsvæske, opløsning
English: For a dose of 4 mg/kg/day
Danish: For en dosis på 4 mg/kg/dag
English: Grey, oval film-coated tablets with dimensions of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
Danish: Grå, ovale, filmovertrukne tabletter, der måler 8,9 mm x 5,0 mm og er præget med ”u25” på den ene side.
English: If you have been told by your doctor that you cannot tolerate or digest some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, før De tager dette lægemiddel, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: Briviact 10 mg film-coated tablets Each 10 mg film-coated tablet contains 88 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Briviact 10 mg filmovertrukne tabletter Hver 10 mg filmovertrukken tablet indeholder 88 mg lactose.
English: Briviact 100 mg film-coated tablets Polyvinyl alcohol
Danish: Briviact 100 mg filmovertrukne tabletter Polyvinylalkohol
English: 0.2 ml/kg/intake
Danish: 0,2 ml/kg/ indtagelse
English: 0.15 ml/kg/intake
Danish: 0,15 ml/kg/ indtagelse
English: Briviact 100 mg film-coated tablets Each film-coated tablet contains 100 mg brivaracetam.
Danish: Briviact 100 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 100 mg brivaracetam.
English: Excipient(s) with known effect: Each ml of solution for injection/infusion contains 3.8 mg sodium.
Danish: Hver ml injektions-/infusionsvæske, opløsning indeholder 3,8 mg natrium.
English: Briviact 25 mg film-coated tablets Each film-coated tablet contains 25 mg brivaracetam.
Danish: Briviact 25 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 25 mg brivaracetam.
English: Purple, oval film-coated tablets with dimensions of 13.0 mm x 7.3 mm debossed with ‘u75' on one side.
Danish: Lilla, ovale, filmovertrukne tabletter, der måler 13,0 mm x 7,3 mm og er præget med ”u75” på den ene side.
English: Briviact 10 mg/ml solution for injection/infusion
Danish: LÆGEMIDLETS NAVN Briviact 10 mg/ml injektions-/infusionsvæske, opløsning
English: Briviact 100 mg film-coated tablets
Danish: Briviact 100 mg filmovertrukne tabletter
English: Briviact 25 mg film-coated tablets
Danish: Briviact 25 mg filmovertrukne tabletter
English: For a dose of 3 mg/kg/day
Danish: For en dosis på 3 mg/kg/dag
English: Briviact 50 mg film-coated tablets Polyvinyl alcohol
Danish: Briviact 50 mg filmovertrukne tabletter Polyvinylalkohol
English: Briviact 10 mg film-coated tablets
Danish: Briviact 10 mg filmovertrukne tabletter
English: Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172).
Danish: Gul jernoxid (E 172) Rød jernoxid (E 172) Sort jernoxid (E 172).
English: Each ml of solution for injection/infusion contains 10 mg brivaracetam.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml injektions-/infusionsvæske, opløsning indeholder 10 mg brivaracetam.
English: For a dose of 2 mg/kg/day
Danish: For en dosis på 2 mg/kg/dag
English: Concomitant treatment with levetiracetam
Danish: Samtidig behandling med levetiracatam
English: Briviact 50 mg film-coated tablets Each film-coated tablet contains 50 mg brivaracetam.
Danish: Briviact 50 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 50 mg brivaracetam.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 50 mg/5 ml
English: How to store Briviact
Danish: Sådan får De Briviact
English: Briviact 75 mg tablets brivaracetam
Danish: LÆGEMIDLETS NAVN Briviact 75 mg tabletter brivaracetam
English: Briviact 50 mg film-coated tablets
Danish: Briviact 50 mg filmovertrukne tabletter
English: Brivaracetam film-coated tablets must be taken orally swallowed in whole with liquid and may be taken with or without food (see section 5.2).
Danish: Brivacatam kan tages med eller uden mad (se pkt.
English: Briviact 100 mg tablets brivaracetam
Danish: LÆGEMIDLETS NAVN Briviact 100 mg tabletter brivaracetam
English: Briviact 10 mg tablets brivaracetam
Danish: LÆGEMIDLETS NAVN Briviact 10 mg tabletter brivaracetam
English: Neutropenia
Danish: Overtræk
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Regler for bortskaffelse Ingen særlige forholdsregler.
English: White to off-white, round film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Danish: Hvide til gråhvide, runde, filmovertrukne tabletter med en diameter på 6,5 mm og er præget med
English: briviact 100 mg
Danish: INFORMATION I BRAILLESKRIFT briviact 100 mg
English: Briviact 25 mg tablets brivaracetam
Danish: LÆGEMIDLETS NAVN Briviact 25 mg tabletter brivaracetam
English: briviact 75 mg
Danish: INFORMATION I BRAILLESKRIFT briviact 75 mg
English: Excipients
Danish: Fortyndere
English: Briviact 50 mg tablets brivaracetam
Danish: LÆGEMIDLETS NAVN Briviact 50 mg tabletter brivaracetam
English: Briviact 10mg/ml solution for injection/infusion brivaracetam
Danish: Briviact 10 mg/ml injektions-/infusionsvæske, opløsning brivaracetam
English: EU/1/15/1073/017 14 film-coated tablets EU/1/15/1073/018 56 film-coated tablets EU/1/15/1073/019 100 x 1 film-coated tablet EU/1/15/1073/027 14 x 1 film-coated tablet
Danish: EU/1/15/1073/017 14 filmovertrukne tabletter EU/1/15/1073/018 56 filmovertrukne tabletter EU/1/15/1073/019 100 x 1 filmovertrukken tablet EU/1/15/1073/027 14 x 1 filmovertrukken tablet
English: Diluents - Sodium chloride 9 mg/ml (0.9 %) solution for injection - Glucose 50 mg/ml (5 %) solution for injection - Lactated Ringer's solution for injection.
Danish: Natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning
English: Briviact 100 mg film-coated tablets brivaracetam
Danish: LÆGEMIDLETS NAVN Briviact 100 mg filmovertrukne tabletter brivaracetam
English: Briviact 75 mg film-coated tablets brivaracetam
Danish: LÆGEMIDLETS NAVN Briviact 75 mg filmovertrukne tabletter brivaracetam
English: Children (≥4 years) and adolescents <50 kg
Danish: Børn (≥ 4 år) og unge < 50 kg Administreres opdelt i to lige store doser
English: Briviact 10 mg film-coated tablets brivaracetam
Danish: LÆGEMIDLETS NAVN Briviact 10 mg filmovertrukne tabletter brivaracetam
English: EU/1/15/1073/013 14 film-coated tablets EU/1/15/1073/014 56 film-coated tablets EU/1/15/1073/015 100 x 1 film-coated tablet EU/1/15/1073/026 14 x 1 film-coated tablet
Danish: EU/1/15/1073/013 14 filmovertrukne tabletter EU/1/15/1073/014 56 filmovertrukne tabletter EU/1/15/1073/015 100 x 1 filmovertrukken tablet EU/1/15/1073/026 14 x 1 filmovertrukken tablet
English: Briviact 25 mg film-coated tablets brivaracetam
Danish: LÆGEMIDLETS NAVN Briviact 25 mg filmovertrukne tabletter brivaracetam
English: Iron oxide yellow (E172) Iron oxide red (E172).
Danish: Gul jernoxid (E 172) Rød jernoxid (E 172).
English: Briviact 50 mg film-coated tablets brivaracetam
Danish: LÆGEMIDLETS NAVN Briviact 50 mg filmovertrukne tabletter brivaracetam
English: - 75 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
Danish: - 75 mg filmovertrukne tabletter: polyvinylalkohol; titandioxid (E 171); macrogol 3350; talcum; gul jernoxid (E 172); rød jernoxid (E 172); sort jernoxid (E 172).
English: EU/1/15/1073/004 168 (3 packs of 56) film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1073/004 168 (3 pakninger a 56) filmovertrukne tabletter
English: Iron oxide yellow (E172) Iron oxide black (E172).
Danish: Gul jernoxid (E 172) Sort jernoxid (E 172).
English: Each film-coated tablet contains 50 mg brivaracetam.
Danish: Hvert 5 ml hætteglas indeholder 50 mg brivaracetam.
English: - 50 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172).
Danish: - 50 mg filmovertrukne tabletter: polyvinylalkohol; titandioxid (E 171); macrogol 3350; talcum; gul jernoxid (E 172); rød jernoxid (E 172).
English: briviact 10 mg
Danish: INFORMATION I BRAILLESKRIFT briviact 10 mg