FrancophonIA/ELRC3.0 huggingface dataset:
English: Fycompa is not considered a strong inducer or inhibitor of cytochrome P450 or UGT enzymes (see section 5.2).
Danish: Fycompa anses ikke for at være en potent induktor eller hæmmer af CYP- eller UGT-enzymer (se pkt.
English: 1.7 to 5.8% of the patients on perampanel in the clinical studies became seizure free during the 3 month maintenance period compared with 0%-1.0% on placebo.
Danish: 1,7-5,8 % af patienterne, der fik perampanel i de kliniske studier, havde ikke epilepsianfald i løbet af den 3-måneders vedligeholdelsesperiode, sammenlignet med 0-1,0 % i placebogruppen.
English: In Study 332, in patients with PGTC seizures who also had concomitant myoclonic seizures, freedom from seizures was achieved in 16.7% (4/24) on perampanel compared to 13.0% (3/23) in those on placebo.
Danish: I studie 332 stoppede anfaldene hos patienter med PGTC-anfald, der også havde samtidige myokloniske anfald, hos 16,7 % (4/24) af patienterne i perampanel-gruppen sammenlignet med 13,0 % (3/23) i placebogruppen.
English: Perampanel as adjunctive therapy in patients 12 years of age and older with idiopathic generalised epilepsy experiencing primary generalised tonic-clonic seizures was established in a multicenter, randomised, double-blind, placebo-controlled study (Study 332).
Danish: Perampanel som tillægsbehandling hos patienter i alderen 12 år og derover med idiopatisk generaliseret epilepsi, der oplever primært generaliserede tonisk-kloniske anfald, blev undersøgt i et randomiseret, dobbeltblindet, placebokontrolleret multicenterstudie (studie 332).
English: 7 film-coated tablets 28 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Danish: 7 filmovertrukne tabletter 28 filmovertrukne tabletter 84 filmovertrukne tabletter 98 filmovertrukne tabletter
English: Each film-coated tablet contains 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg perampanel.
Danish: Hver filmovertrukket tablet indeholder 2 mg, 4 mg, 6 mg, 8 mg, 10 mg eller 12 mg perampanel.
English: In patients with concomitant absence seizures, freedom from seizures was achieved in 22.2% (6/27) on perampanel compared to 12.1% (4/33) on placebo.
Danish: Hos patienter med samtidige absenceanfald stoppede anfaldene hos 22,2 % (6/27) af patienterne i perampanel-gruppen sammenlignet med 12,1 % (4/33) i placebogruppen.
English: Tablet core (6 mg, 8 mg, 10 mg and 12 mg tablets) Lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, microcrystalline cellulose, magnesium stearate (E470b)
Danish: Tabletkerne (6 mg, 8 mg, 10 mg og 12 mg tabletter) Lactosemonohydrat, lavsubstitueret hydroxypropylcellulose, povidon, mikrokrystallinsk cellulose, magnesiumstearat (E470b)
English: 2 mg tablet - pack of 7, 28 and 98
Danish: 2 mg tablet - pakning med 7, 28 og 98
English: Cartons of 7, 28, 84 and 98 tablets
Danish: Kartoner med 7, 28, 84 og 98 tabletter
English: Treatment with Fycompa should be initiated with a dose of 2 mg/day.
Danish: Behandling med Fycompa bør påbegyndes med en dosis på 2 mg/dag.
English: What you need to know before you take Fycompa
Danish: Det skal du vide, før du begynder at tage Fycompa
English: Carton of 7, 28 and 98 tablets
Danish: Karton med 7, 28 og 98 tabletter
English: 4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets - packs of 7, 28, 84 and 98
Danish: 4 mg, 6 mg, 8 mg, 10 mg, 12 mg tabletter - pakninger med 7, 28, 84 og 98
English: Each bottle of 340 ml contains 170 mg perampanel
Danish: Hver flaske med 340 ml indeholder 170 mg perampanel.
English: Dizziness Somnolence
Danish: Svimmelhed Døsighed
English: Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS)
Danish: Svære kutane bivirkninger (SCARs), herunder lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS)
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: For dosing please use the oral syringe and adaptor provided.
Danish: Brug den medfølgende orale sprøjte og adapter til dosering.
English: Tell your doctor if you are taking or have recently taken these medicines as your dose may need to be adjusted.
Danish: Fortæl altid lægen, hvis du tager disse former for medicin eller har gjort det for nylig, da det kan være nødvendigt at justere din dosis.
English: Treatment with Fycompa should be initiated with a dose of 2 mg/day (4 ml/day).
Danish: Behandling med Fycompa bør påbegyndes med en dosis på 2 mg/dag (4 ml/dag).
English: perampanel oral suspension achieves equivalent AUC0-inf and approximately 23 % lower Cmax and 2 hours delay in time to peak exposure (tmax) compared to the tablet formulation.
Danish: Da en enkeltdosis på 12 mg af begge formuleringer blev administreret sammen med et måltid med et højt fedtindhold, opnåede perampanel oral suspension en ækvivalent AUC0-inf og en ca. 23 % lavere Cmax og en 2-timers forsinkelse i tiden til den maksimale eksponering (tmax) sammenlignet med tabletformuleringen.
English: Perampanel is eliminated almost exclusively by metabolism followed by rapid excretion of metabolites; only trace amounts of perampanel metabolites are observed in plasma.
Danish: Perampanel elimineres næsten udelukkende ved metabolisme efterfulgt af en hurtig udskillelse af metabolitterne.
English: Depending upon individual clinical response and tolerability, the dose may be increased or decreased 2 mg at a time (see section 4.2).
Danish: Afhængig af individuelt klinisk respons og tolerabilitet, kan dosis øges eller nedsættes i trin på 2 mg (se pkt.
English: In a population pharmacokinetic analysis of patients with partial-onset seizures having creatinine clearances ranging from 39 to 160 mL/min and receiving perampanel up to 12 mg/day in placebo-controlled clinical trials, perampanel clearance was not influenced by creatinine clearance.
Danish: I en populationsfarmakokinetisk analyse af patienter med partielle anfald, der havde kreatinin-clearance i intervallet fra 39 til 160 ml/min og fik perampanel op til 12 mg/dag i placebokontrollerede kliniske studier, var perampanel-clearance ikke påvirket af kreatinin-clearance.
English: Your doctor may reduce your dose slowly to avoid your fits (seizures) coming back or getting worse.
Danish: Tag Fycompa, så længe som lægen anbefaler det. Du må ikke holde op, medmindre lægen anviser det. Din læge kan gradvist reducere din dosis, så du undgår, at dine anfald (epileptiske anfald) vender tilbage eller forværres.
English: 6 mg tablet: Ferric Oxide, Red (E172)
Danish: 6 mg tablet: Jernoxid, rød (E172)
English: In all three trials, following a 6-week Baseline Phase to establish baseline seizure frequency prior to randomisation, subjects were randomised and titrated to the randomised dose.
Danish: I alle tre studier blev personerne randomiseret og titreret til den randomiserede dosis efter en 6-ugers baselinefase, der havde til formål at etablere hyppigheden af epilepsianfald ved baseline før randomisering.
English: In a population pharmacokinetic analysis of patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in a placebo-controlled clinical study, perampanel clearance was not influenced by baseline creatinine clearance.
Danish: I en populationsfarmakokinetisk analyse af patienter med primært generaliserede tonisk-kloniske anfald, der fik perampanel op til 8 mg/dag i et placebokontrolleret klinisk studie, var perampanel-clearance ikke påvirket af kreatinin-clearance ved baseline.
English: Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of perampanel.
Danish: Alvorlige hudreaktioner, herunder lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS), er rapporteret i forbindelse med brugen af perampanel.
English: Effect of cytochrome P450 inducers on perampanel pharmacokinetics
Danish: CYP-induktorers indvirkning på perampanels farmakokinetik
English: Other concomitant (non- anti-epileptic) cytochrome P450 inducing or inhibiting medicinal products
Danish: Andre samtidige (ikke-antiepileptiske) CYP-inducerende eller -hæmmende lægemidler
English: In a population pharmacokinetic analysis of patients with partial-onset seizures (age range 12 to 74 years) and primary generalised tonic-clonic seizures (age range 12 to 58 years), and receiving perampanel up to 8 or 12 mg/day in placebo-controlled clinical trials, no significant effect of age on perampanel clearance was found.
Danish: I en populationsfarmakokinetisk analyse af patienter med partielle anfald (aldersinterval fra 12 til 74 år) og primært generaliserede tonisk-kloniske anfald (aldersinterval fra 12 til 58 år), der fik perampanel op til 8 eller 12 mg/dag i placebokontrollerede kliniske studier, blev der ikke fundet nogen signifikant virkning af alder på perampanel-clearance.
English: A statistically significant effect on the reduction in 28-day seizure frequency (Baseline to Treatment Phase) as compared to the placebo group was observed with perampanel treatment at doses of 4 mg/day (Study 306), 8 mg/day (Studies 304, 305 and 306), and 12 mg/day (Studies 304 and 305).
Danish: De puljede 50 %-responsrater var 19 % med placebo, 29 % med 4 mg, 35 % med 8 mg og 35 % med 12 mg. Der blev observeret en statistisk signifikant reduktion i anfaldshyppigheden efter 28 dage (baseline til behandlingsfasen), sammenlignet med placebogruppen, med perampanel-behandling ved doser på 4 mg/dag (studie 306), 8 mg/dag (studie 304, 305 og 306) og 12 mg/dag (studie 304 og 305).
English: In a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in placebo-controlled clinical trials, perampanel clearance in females (0.54 l/h) was 18% lower than in males (0.66 l/h).
Danish: I en populationsfarmakokinetisk analyse af patienter med partielle anfald, der fik perampanel op til 12 mg/dag, og patienter med primært generaliserede tonisk-kloniske anfald, der fik perampanel op til 8 mg/dag, i placebokontrollerede kliniske studier, var perampanel-clearance hos kvinder (0,54 l/t) 18 % lavere end hos mænd (0,66 l/t).
English: Polyethylene terephthalate (PET) bottle with a child-resistant (CR) polypropylene (PP) closure; each bottle contains 340 ml of suspension in an outer cardboard carton.
Danish: Flaske af polyethylenterephthalat (PET) med børnesikret polypropylen (PP) lukke.
English: 1.7 fold decrease
Danish: 1,7 gange reduktion
English: Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased by increments of 2 mg/day to 12 mg/day.
Danish: Afhængigt af individuel klinisk respons og tolerabilitet ved en dosis på 8 mg/dag, kan dosis øges med stigninger på 2 mg/dag til 12 mg/dag.
English: Fycompa 6 mg, 8 mg, 10 mg, 12 mg film-coated tablets
Danish: Fycompa 6 mg, 8 mg, 10 mg, 12 mg filmovertrukne tabletter
English: Mood deteriorated following dosing of 12 mg/day only; the changes in mood were small and reflected a general lowering of alertness.
Danish: Ændringerne i stemningslejet var små og afspejlede en generel reduktion i opmærksomheden.
English: Drug metabolising enzyme inhibition
Danish: Lægemiddelmetaboliserende enzyminduktion
English: Microcrystalline cellulose Magnesium stearate (E470b)
Danish: Mikrokrystallinsk cellulose Magnesiumstearat (E470b)
English: A similar result was seen in a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in placebo-controlled clinical trials.
Danish: Et lignende resultat blev set i en populationsfarmakokinetisk analyse af patienter med partielle anfald, der fik perampanel op til 12 mg/dag, og hos patienter med primært generaliserede tonisk-kloniske anfald, der fik perampanel op til 8 mg/dag, i placebokontrollerede kliniske studier.
English: Patients who are taking concomitant medicinal products that do not shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 2-week intervals.
Danish: Patienter, der samtidig tager lægemidler, som ikke forkorter perampanels halveringstid (se pkt.
English: Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported (frequency unknown; see section 4.8) in association with perampanel treatment.
Danish: Svære kutane bivirkninger (SCARs), herunder lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS), som kan være livstruende eller dødelig, er rapporteret (hyppighed ikke kendt; se pkt.
English: 2 mg tablet: Ferric Oxide, Yellow (E172), Ferric Oxide, Red (E172) 4 mg tablet: Ferric Oxide, Red (E172)
Danish: 2 mg tablet: Jernoxid, gul (E172), jernoxid, rød (E172) 4 mg tablet: Jernoxid, rød (E172)
English: 7 Turn upright and remove the oral syringe.
Danish: Vend flasken om, og fjern den orale sprøjte.
English: Each ml of oral suspension contains 0.5 mg perampanel
Danish: Hver ml oral suspension indeholder 0,5 mg perampanel.
English: Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg film-coated tablets Perampanel
Danish: Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg og 12 mg filmovertrukne tabletter Perampanel
English: At doses of 12 mg/day Fycompa may decrease the effectiveness of progestative-containing hormonal contraceptives; in this circumstance additional non-hormonal forms of contraception are recommended when using Fycompa (see section 4.5).
Danish: Ved doser på 12 mg/dag kan Fycompa nedsætte virkningen af progesteron-indeholdende hormonal antikonception.
English: How to use Fycompa
Danish: Sådan skal du bruge Fycompa
English: Depending upon individual clinical response and tolerability at a dose of 8 mg/day (16 ml/day), the dose may be increased by increments of 2 mg/day (4 ml/day) to 12 mg/day (24 ml/day).
Danish: Afhængigt af individuel klinisk respons og tolerabilitet ved en dosis på 8 mg/dag (16 ml/dag) kan dosis øges med stigninger på 2 mg/dag (4 ml/dag) til 12 mg/dag (24 ml/dag).
English: Systemic Symptoms (DRESS)*
Danish: Lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS)*
English: Diplopia Vision blurred
Danish: Diplopi Sløret syn
English: How to take Fycompa
Danish: Sådan skal du tage Fycompa
English: Perampanel dosing for patients with mild and moderate impairment should not exceed 8 mg. Use in patients with severe hepatic impairment is not recommended.
Danish: Perampanel-dosering til patienter med let til moderat nedsat leverfunktion bør ikke overstige 8 mg.
English: Suicidal ideation
Danish: Selvmordstanker
English: Red, round, biconvex tablet, engraved with E277 on one side and ‘4' on other side
Danish: Rød, rund, bikonveks tablet, præget med E277 på den ene side og med '4' på den anden side
English: - Some other medicines such as rifampicin (a medicine used to treat bacterial infections),
Danish: - Nogle andre former for medicin som refampicin (et lægemiddel til behandling af bakterielle infektioner), hypericum (prikbladet perikon) (et lægemiddel, der anvendes til behandling af lette angsttilfælde) og ketoconazol (et lægemiddel til behandling af svampeinfektioner) kan påvirke
English: Fycompa 2 mg, 4 mg film-coated tablets
Danish: Fycompa 2 mg, 4 mg filmovertrukne tabletter
English: Each ml contains 0.5 mg perampanel.
Danish: Hver ml indeholder 0,5 mg perampanel.
English: Tell your doctor if you are taking or have recently taken this medicine as your dose may need to be adjusted.
Danish: Fortæl altid lægen, hvis du tager denne medicin, da det kan være nødvendigt at justere din dosis.
English: Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with perampanel treatment (see section 4.4).
Danish: Svære kutane bivirkninger (SCARs), herunder lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS), er rapporteret i forbindelse med behandling med perampanel (se pkt.
English: In the fertility study in rats, prolonged and irregular oestrous cycles were observed at the maximum tolerated dose (30 mg/kg) in females; however, these changes did not affect fertility and early embryonic development.
Danish: I fertilitetsstudier med rotter blev der observeret langvarige og uregelmæssige østrus-cyklusser ved den maksimalt tolererede dosis (30 mg/kg) hos hunner.
English: What Fycompa contains
Danish: Fycompa indeholder:
English: Orange, round, biconvex tablet, engraved with E275 on one side and ‘2' on other side
Danish: Orange, rund, bikonveks tablet, præget med E275 på den ene side og med '2' på den anden side
English: 1.9 fold decrease
Danish: Oxcarbazepin 1,9 gange reduktion
English: Excipient with known effect: Each 2 mg tablet contains 78.5 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver 2 mg tablet indeholder 78,5 mg lactose (som monohydrat).
English: In the fertility study in rats, prolonged and irregular oestrous cycles were observed at high-dose (30 mg/kg) in females; however, these changes did not affect the fertility and early embryonic development.
Danish: I fertilitetsstudier med rotter blev der observeret langvarige og uregelmæssige østrus-cyklusser ved høj dosis (30 mg/kg) hos hunner.
English: Fycompa contains sorbitol
Danish: Fycompa indeholder lactose
English: Each millilitre contains 0.5 mg of perampanel.
Danish: Hver milliliter indeholder 0,5 mg perampanel.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Fycompa.
Danish: Fycompa indeholder sorbitol Kontakt lægen, før du tager Fycompa, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Depending upon individual clinical response and tolerability at a dose of 8 mg/day (16 ml/day), the dose may be increased up to 12 mg/day (24 ml/day), which may be effective in some patients (see section 4.4).
Danish: Afhængigt af individuelt klinisk respons og tolerabilitet ved en dosis på 8 mg/dag (16 ml/dag) kan dosis øges op til 12 mg/dag (24 ml/dag), hvilket kan være effektivt til nogle patienter (se pkt.
English: Titanium dioxide (E171) Ferric oxide, red (E172)
Danish: Titandioxid (E171) Jernoxid, rød (E172)
English: Patients who are taking concomitant medicinal products that shorten the half-life of perampanel (see section 4.5) should be titrated no more frequently than at 1-week intervals.
Danish: Patienter, der samtidig tager lægemidler, som forkorter perampanels halveringstid (se pkt.
English: Green, round, biconvex tablet, engraved with E296 on one side and ‘10' on other side
Danish: Grøn, rund, bikonveks tablet, præget med E296 på den ene side og med '10' på den anden side
English: Each tablet contains 8 mg perampanel.
Danish: Hver tablet indeholder 8 mg perampanel.
English: Depending upon individual clinical response and tolerability at a dose of 8 mg/day, the dose may be increased up to 12 mg/day, which may be effective in some patients (see section 4.4).
Danish: Afhængigt af individuelt klinisk respons og tolerabilitet ved en dosis på 8 mg/dag kan dosis øges op til 12 mg/dag, hvilket kan være effektivt til nogle patienter (se pkt.
English: Excipient with known effect: Each 8 mg tablet contains 149.0 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver 8 mg tablet indeholder 149,0 mg lactose (som monohydrat).
English: Blue, round, biconvex tablet, engraved with E297 on one side and ‘12' on other side
Danish: Blå, rund, bikonveks tablet, præget med E297 på den ene side og med '12' på den anden side
English: Pink, round, biconvex tablet, engraved with E294 on one side and ‘6' on other side
Danish: Lyserød, rund, bikonveks tablet, præget med E294 på den ene side og med '6' på den anden side
English: Fycompa 8 mg tablets Perampanel
Danish: Fycompa 8 mg tabletter Perampanel
English: Each film-coated tablet contains 8 mg perampanel.
Danish: Hver filmovertrukket tablet indeholder 8 mg perampanel.
English: The dose may be increased based on clinical response and tolerability by increments of 2 mg (4 ml) (either weekly or every 2 weeks as per half-life considerations described below) to a maintenance dose of 4 mg/day (8 ml/day) to 8 mg/day (16 ml/day).
Danish: Dosis kan øges på grundlag af klinisk respons og tolerabilitet med stigninger på 2 mg (4 ml) (enten ugentligt eller hver 2. uge under hensyntagen til halveringstiden som beskrevet nedenfor) til en vedligeholdelsesdosis på 4 mg/dag (8 ml/dag) til 8 mg/dag (16 ml/dag).
English: Titanium dioxide (E171) Ferric oxide, yellow (E172) Ferric oxide, red (E172)
Danish: Titandioxid (E171) Jernoxid, gul (E172) Jernoxid, rød (E172)
English: Purple, round, biconvex tablet, engraved with E295 on one side and ‘8' on other side
Danish: Lilla, rund, bikonveks tablet, præget med E295 på den ene side og med '8' på den anden side
English: Each tablet contains 10 mg perampanel.
Danish: Hver tablet indeholder 10 mg perampanel.
English: Fycompa 8 mg film-coated tablets 8 mg - packs of 7, 28, 84 and 98
Danish: Fycompa 8 mg filmovertrukne tabletter 8 mg - pakning med 7, 28, 84 og 98
English: Excipient with known effect: Each 6 mg tablet contains 151.0 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver 6 mg tablet indeholder 151,0 mg lactose (som monohydrat).
English: Each tablet contains 12 mg perampanel.
Danish: Hver tablet indeholder 12 mg perampanel.
English: Fycompa 8 mg film-coated tablets
Danish: Fycompa 8 mg filmovertrukne tabletter
English: Each tablet contains 4 mg perampanel.
Danish: Hver tablet indeholder 4 mg perampanel.
English: In a population pharmacokinetic analysis of patients with partial-onset seizures receiving perampanel up to 12 mg/day and patients with primary generalised tonic-clonic seizures receiving perampanel up to 8 mg/day in placebo-controlled clinical trials, a linear relationship was found between dose and perampanel plasma concentrations.
Danish: Hos raske personer øgedes plasmakoncentrationerne af perampanel direkte proportionalt med de administrerede doser i intervallet fra 2-12 mg. I en populationsfarmakokinetisk analyse af patienter med partielle anfald, der fik perampanel i doser på op til 12 mg/dag, og patienter med primært generaliserede tonisk-kloniske anfald, der fik perampanel op til 8 mg/dag, i placebokontrollerede kliniske studier, blev der fundet et lineært forhold mellem dosis og perampanel-plasmakoncentration.
English: Each tablet contains 2 mg perampanel.
Danish: Hver tablet indeholder 2 mg perampanel.
English: Each film-coated tablet contains 10 mg perampanel.
Danish: Hver filmovertrukket tablet indeholder 10 mg perampanel.
English: Each film-coated tablet contains 12 mg perampanel.
Danish: Hver filmovertrukket tablet indeholder 12 mg perampanel.
English: What you need to know before you take Fycompa 3.
Danish: Det skal du vide, før du begynder at tage Fycompa Sådan skal du tage Fycompa Bivirkninger
English: Excipient with known effect: Each 10 mg tablet contains 147.0 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver 10 mg tablet indeholder 147,0 mg lactose (som monohydrat).
English: If any of these happens, talk to your doctor or pharmacist.
Danish: Hvis du får nogle af disse symptomer, skal du kontakte lægen eller apoteket.
English: Excipient with known effect: Each 12 mg tablet contains 145.0 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver 12 mg tablet indeholder 145,0 mg lactose (som monohydrat).
English: Fycompa 10 mg tablets Perampanel
Danish: Fycompa 10 mg tabletter Perampanel
English: Each film-coated tablet contains 4 mg perampanel.
Danish: Hver filmovertrukket tablet indeholder 4 mg perampanel.
English: Each tablet contains 6 mg perampanel.
Danish: Hver tablet indeholder 6 mg perampanel.
English: Excipient with known effect: Each 4 mg tablet contains 157.0 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver 4 mg tablet indeholder 157,0 mg lactose (som monohydrat).