natgillin/translations-raw huggingface dataset:
I et 24 ugers placebokontrolleret studie hos patienter med symptomatisk KOL, reducerede Anoro Ellipta risikoen for moderat/svær KOL-eksacerbation med 50 % sammenlignet med placebo (baseret på analyse af tiden til første eksacerbation; hazard ratio (HR) 0,5; 95% CI:0,3, 0,8; p = 0,004*), med 20 % sammenlignet med umeclidinium (HR 0,8; 95% CI: 0,5, 1,3; p = 0,391) og med 30 % sammenlignet med vilanterol (HR 0,7; 95% CI: 0,4, 1,1; p = 0,121). 
In a 24-week placebo-controlled study in patients with symptomatic COPD, ANORO ELLIPTA reduced the risk of a moderate/severe COPD exacerbation by 50% compared with placebo (based on analysis of time to first exacerbation: Hazard Ratio (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); by 20% compared with umeclidinium (HR 0.8; 95% CI: 0.5, 1.3; p=0.391); and by 30% compared with vilanterol (HR 0.7; 95% CI: 0.4, 1.1; p=0.121).
Anoro Ellipta er til inhalationsbrug. 
ANORO ELLIPTA is for inhalation use.
Dette svarer til en afdelt dosis på 74,2 mikrogram umeclidiniumbromid svarende til 62,5 mikrogram umeclidinium og 25 mikrogram vilanterol (som trifenatat). 
This corresponds to a pre-dispensed dose of 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate).
Overfølsomhedsreaktioner, herunder Udslæt 
Hypersensitivity reactions including: Rash
Brug ikke lægemidlet efter den udløbsdato, der står på æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP'.
Inhalatoren indeholder to laminerede aluminiumsfolie-blister (en for hvert aktivt stof) med enten 7 eller 30 doser. 
The inhaler contains two aluminium foil laminate blisters of 7 or 30 doses.
In vitro-studier viste, at vilanterol primært metaboliseres via cytochrom P450 3A4 (CYP3A4) og er et substrat for transportproteinet P-glykoprotein (P-gp). 
In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate for the P-gp transporter.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INTERMEDIÆR YDRE KARTON (UDEN BLUE BOX - KUN MULTIPAKNING) 55 mikrogram/22 mikrogram 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 55 micrograms/22 micrograms
Datoen ”Kasseres senest” er 6 uger efter den dag, hvor bakken åbnes. 
The “Discard by” date is 6 weeks from the date you open the tray.
I det andet studie viste Anoro Ellipta 55/22 mikrogram forbedringer sammenlignet med placebo i ændring fra baseline af lungevolumen, målt ved trough og 3 timer efter dosering ved uge 12 (inspiratorisk kapacitet: henholdsvis 198 ml og 238 ml, residualvolumen: henholdsvis -295 ml og -351 ml og funktionel residualkapacitet: henholdsvis -238 ml og -302 ml, alle p < 0,001∗). 
In the second study, ANORO ELLIPTA 55/22 micrograms showed improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 (inspiratory capacity: 198 ml and 238 ml respectively, residual volume: -295 ml and -351 ml respectively and functional residual capacity: -238 ml and -302 ml respectively); all p<0.001∗).
Der er ikke set kliniske relevante påvirkninger af plasmaglukose i kliniske studier med umeclidinium/vilanterol ved den anbefalede terapeutiske dosis. 
No clinically relevant effects on plasma glucose were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose.
Anoro Ellipta er kun beregnet til inhalation. 
ANORO ELLIPTA is for inhalation use only.
Anoro Ellipta (N=217) versus tiotropium 18 mikrogram (N=215) (studie DB2113374) 
ANORO ELLIPTA (N = 217) versus tiotropium 18 mcg (N = 215) (Study DB2113374)
Åbn beskyttelseshætten, når du er klar til at inhalere en dosis. 
Open the cover when ready to inhale a dose.
Kan forekomme hos op til 1 ud af 1.000 personer: 
These may affect up to 1 in 1,000 people:
Pakningsstørrelser med inhalator med 7 eller 30 doser. 
Pack sizes of 7 or 30 dose inhalers.
Inhalatorens mundstykke kan rengøres med en tør serviet, før beskyttelseshætten lukkes c) Luk inhalatoren 
The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERETIKET (MED BLUE BOX - MULTIPAKNING) 55 mikrogram/22 mikrogram 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 55 micrograms/22 micrograms
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (ENKELTPAKNINGER) 55 mikrogram/22 mikrogram 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 55 micrograms/22 micrograms
• ømhed i halsen 
• sore throat
Det kliniske udviklingsprogram inkluderede 2.354 patienter, der fik umeclidinium/vilanterol én gang daglig i et klinisk fase III-studie, der varede 24 uger eller længere, hvor 1.296 patienter fik den anbefalede dosis på 55/22 mikrogram i studier af 24 ugers varighed. 
The clinical development programme included 2,354 patients who received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1,296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 micrograms in a 12-month study.
Der forventes ingen klinisk relevant lægemiddelinteraktion på baggrund af størrelsesordenen af disse ændringer, når umeclidinium/vilanterol administreres samtidigt med P-gp-hæmmere. 
Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with P-gp inhibitors.
Hvis der opstår paradoks bronkospasme, skal behandlingen med umeclidinium/vilanterol omgående seponeres og anden behandling iværksættes, hvis det er nødvendigt. 
Treatment with umeclidinium/vilanterol should be discontinued immediately if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.
Ellipta-inhalatoren består af en lysegrå inhalator af plast med en rød beskyttelseshætte over mundstykket og en dosistæller. 
The Ellipta inhaler consists of a light grey plastic body, a red mouthpiece cover and a dose counter.
Obstipation Mundtørhed 
Bladder outlet obstruction
Brug af anden medicin sammen med Anoro Ellipta 
Other medicines and ANORO ELLIPTA
Orofaryngeale smerter Dysfoni 
Oropharyngeal pain Dysphonia
Efter administration af umeclidinium/vilanterol med 2 gange den anbefalede dosis af umeclidinium og den anbefalede dosis af vilanterol, viste patienter med moderat nedsat leverfunktion (Child-Pugh-klasse B) ingen tegn på øget systemisk eksponering over for hverken umeclidinium eller vilanterol (Cmax og AUC), og der var ingen tegn på ændret proteinbinding mellem patienter med moderat nedsat leverfunktion og raske personer. 
Patients with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of altered protein binding between patients with moderate hepatic impairment and healthy volunteers.
Anoro Ellipta 55 mikrogram/22 mikrogram inhalationspulver, afdelt 
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed
Urinvejsinfektion Sinuitis 
Urinary tract infection Sinusitis
Inhalationspulver, afdelt 1 inhalator med 30 doser Del af en multipakning, må ikke sælges separat. 
Component of a multipack, can't be sold separately.
Anoro Ellipta viste en stigning fra baseline i antal dage uden behov for anfaldsmedicin (gennemsnitligt 11,1 %) sammenlignet med et fald fra baseline med placebo (gennemsnitligt 
ANORO ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared with placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion of days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline on placebo (on average 0.9%).
Anoro Ellipta 55/22 mikrog inhalationspulver umeclidinium/vilanterol 
ANORO ELLIPTA 55/22 mcg inhalation powder umeclidinium/vilanterol
Farmakoterapeutisk klassifikation: Midler mod obstruktiv lungesygdom, adrenergika i kombination med antikolinergika, herunder trestof-behandling med kortikosteroider, ATC-kode: R03AL03. 
triple combinations with corticosteroids, ATC code: R03AL03
Glaxo Operations UK Limited (handler som Glaxo Wellcome Operations) Priory Street 
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street
Glaxo Operations UK Ltd. (handler som Glaxo Wellcome Operations) Harmire Road 
Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Harmire Road
Glaxo Operations UK Limited (handler som Glaxo Wellcome Operations) Harmire Road 
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Harmire Road
Hver afgivet dosis indeholder 55 mikrogram umeclidinium (svarende til 65 mikrogram umeclidiniumbromid) og 22 mikrogram vilanterol (som trifenatat). 
Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms vilanterol (as trifenatate).
Glaxo Operations UK Ltd. (handler som Glaxo Wellcome Operations) Priory Street 
Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Anoro Ellipta 55 mikrogram forbedrede fysisk udholdenhed målt ved fysisk anstrengelse sammenlignet med placebo, vurderet ved Endurance Shuttle Walk Test (ESWT) i ét studie, men ikke i det andet. 
ANORO ELLIPTA 55/22 micrograms improved exercise endurance time compared with placebo, as evaluated with the endurance shuttle walk test (ESWT), in one study but not the second and improved lung volume measures compared with placebo in both studies in adult COPD patients with hyperinflation (functional residual capacity [FRC] >120%).
Umeclidinium er substrat for CYP2D6. 
Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6).
Hver enkelt inhalation leverer en afgivet dosis (den dosis, der forlader mundstykket) på 65 mikrogram umeclidiniumbromid svarende til 55 mikrogram umeclidinium og 22 mikrogram vilanterol (som trifenatat). 
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 65 micrograms umeclidinium bromide equivalent to 55 micrograms of umeclidinium and 22 micrograms of vilanterol (as trifenatate).
KOL- eksacerbationer 
LIST OF EXCIPIENTS
Hvis du er gravid, må du ikke tage dette lægemiddel, medmindre du har aftalt det med lægen. 
Don't use this medicine if you are pregnant unless your doctor tells you that you can.
Anoro Ellipta (N=413) versus 
ANORO ELLIPTA (N =
Anoro Ellipta 55 mikrogram/22 mikrogram inhalationspulver, afdelt umeclidinium/vilanterol 
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol
Hver enkelt inhalation afgiver en leveret dosis (den dosis, der afgives fra mundstykket) på 55 mikrogram umeclidinium (svarende til 65 mikrogram umeclidiniumbromid) og 22 mikrogram vilanterol (som trifenatat). 
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate)
Sjælden Sjælden Sjælden 
Rare Rare Rare
Tørremiddel Bakke 
Constipation Dry mouth
• udslæt 
• tremor
Derudover blev der ikke observeret nogen klinisk signifikante effekter på hjerterytmen ved 24-timers Holtermonitorering hos 53 patienter med KOL, der blev behandlet med umeclidinium/vilanterol 55/22 mikrogram én gang daglig i et studie af 6 måneders varighed eller hos yderligere 55 patienter, der fik umeclidinium/vilanterol 113/22 mikrogram én gang daglig i et andet studie af 6 måneders varighed samt 226 patienter, der umeclidinium/vilanterol 113/22 mikrogram én gang daglig i studiet af 12 måneders varighed. 
In addition, no clinically significant effects on cardiac rhythm were observed on 24-hour Holter monitoring in 53 patients with COPD who were treated with umeclidinium/vilanterol 55/22 micrograms once daily in
Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter. 
Don't use this medicine if you are breast-feeding unless your doctor tells you that you can.
Kontakt straks lægen eller apoteket, hvis du ved et uheld har taget for meget af Anoro Ellipta, da du kan have brug for lægehjælp. 
If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention.
832 patienter fik en højere dosis på 113/22 mikrogram i studier af 24 ugers varighed og 226 patienter fik 113/22 mikrogram i et studie af 12 måneders varighed. 
one 6-month study, or in a further 55 patients who received umeclidinium/vilanterol 113/22 micrograms once daily in another 6-month study and 226 patients who received 113/22 micrograms once daily in the 12-month study.
I et studie af den præ- og postnatale udvikling hos rotter resulterede subkutan administration af umeclidinium i lavere vægtstigning og nedsat fødeindtagelse hos moderen, og i let nedsatte kropsvægte hos afkommet inden fravænning. 
In a pre- and post-natal study, subcutaneous administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose (approximately 80-times the human clinical exposure of umeclidinium 55 micrograms, based on AUC).
Efter administration af umeclidinium/vilanterol med 2 gange den anbefalede dosis af umeclidinium og den anbefalede dosis af vilanterol, viste patienter med svært nedsat nyrefunktion ingen tegn på øget systemisk eksponering over for hverken umeclidinium eller vilanterol (Cmax og AUC). 
Patients with severe renal impairment showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of altered protein binding between patients with severe renal impairment and healthy volunteers.
Sådan skal du tage Anoro Ellipta 
How to use ANORO ELLIPTA
Hvis du har taget for meget Anoro Ellipta 
If you use more ANORO ELLIPTA than you should
Placebo (N=280) Anoro Ellipta (N=413) versus umeclidinium 55 mikrogram (N=418) Anoro Ellipta (N=413) versus vilanterol 22 mikrogram (N=421) 
Placebo (N = 280) ANORO ELLIPTA (N =
Øjne 
versus
Den totale behandlingsperiode var 17 uger. 
The total treatment period was 17 weeks.
Hvor meget skal der tages 
How much to take
De tilgængelige data er utilstrækkelige til at nå til nogen konklusion. 
The available data are insufficient to reach any conclusions.
Nedsat appetit Øget appetit 
Decreased appetite Increased appetite
Efter første åbning: 90 dage. 
After first opening: 90 days.
Sikkerhed og virkning er endnu ikke kendt for denne aldersgruppe. 
The safety and effectiveness are not yet known in this age group.
Oral suspension Hvid til off-white suspension 
Oral suspension White to off-white suspension
Dato for første markedsføringstilladelse: 23/07/2012 Dato for seneste fornyelse: 6. April 2017 
Date of first authorisation: 23/07/2012 Date of latest renewal: 6 April 2017
Studielægemidlet blev givet én gang dagligt. 
Study drug was given once per day.
Hvis der er suspension tilbage i flasken mere end 90 dage efter, den først blev åbnet, må du ikke bruge det. 
If you have any suspension left in the bottle more than 90 days after it was first opened, you should not use it.
Det kan tage et par uger at finde frem til den rette dosis Fycompa til dig. 
It may take a few weeks to find the right dose of Fycompa for you.
Ældre (fra 65 år) 
Elderly (65 years of age and above)
Tal med lægen før du drikker alkohol. 
Speak to your doctor before drinking alcohol.
Det kan også forårsage, at du får usædvanlige eller ekstreme ændringer i din adfærd eller dit humør. 
It may also cause you to have unusual or extreme changes in behaviour or mood.
Resultaterne hos disse unge var sammenlignelige med de resultater, der blev set hos den voksne population. 
The results in these adolescents were similar to those seen in the adult population.
EXP Efter første åbning: anvendes inden for 90 dage. 
EXP After first opening: use within 90 days.
Låget passer korrekt, når PIBA er på plads. 
The cap fits properly when the PIBA is in place.
- Fycompa kan gøre dig aggressiv, vred eller voldelig. 
- Fycompa may make you aggressive, angry or violent.
Niveauerne nåede et maksimum efter en time og var 3,65 gange niveauet i plasma. 
Levels peaked at one hour and were 3.65 times the levels in plasma.
35 % forhøjelse 
35% increase
Dette var ikke statistisk signifikant (p = 0,96). 
This was not statistically significant (p = 0.96).
Det kan tages sammen med eller uden mad, men fortrinsvis altid under de samme betingelser. 
It may be taken with or without food, but preferably always under the same conditions.
Mekanismen for denne risiko er ukendt, og tilgængelige data ekskluderer ikke muligheden for en forøget risiko med perampanel. 
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for perampanel.
Du kan opleve forvirring, ophidselse og aggressiv opførsel. 
You may experience confusion, agitation and aggressive behaviour.
- Orale præventionsmidler (som også kaldes ”hormonal prævention”). 
- Oral contraceptives (also called “hormonal contraceptives”).
Du må ikke stoppe behandlingen uden først at diskutere det med lægen. 
Do not stop treatment without first discussing it with your doctor.
12 mg (24 ml) afhængigt af dit respons. 
and 12 mg (24 ml) depending on your response.
Vask den orale sprøjte med rent vand, og tør grundigt. 
Wash the oral syringe with clean water and dry thoroughly.
Omrystes i mindst 5 sekunder før brug. 
Shake for at least 5 seconds before use.
Studie 332 inkluderede 22 unge fra 12 til 18 år. 
Study 332 included 22 adolescents between the ages of 12 and 18.
Den må ikke tygges, knuses eller deles. 
It should not be chewed, crushed or split.
Tmax var forsinket med ca. 1 time sammenlignet med fastende tilstande. 
The tmax was delayed by approximately 1 hour compared to that under fasted conditions.
Den følgende konvention er blevet brugt til klassifikation af bivirkninger: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
The following convention has been used for the classification of adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data).
Ud af de 140 personer, som gennemførte studie 332, indgik 114 personer (81,4 %) i forlængelsesfasen. 
Of the 140 subjects who completed the Study 332, 114 subjects (81.4%) had entered the Extension phase.
Der er utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af perampanel til gravide kvinder. 
There are limited amounts of data (less than 300 pregnancy outcomes) from the use of perampanel in pregnant women.
Du kan tage Fycompa sammen med eller uden mad. 
You can take Fycompa with or without food.
Fycompa skal titreres i henhold til det individuelle patientrespons for at optimere balancen mellem virkning og tolerabilitet. 
Fycompa must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability.
Den gennemsnitlige daglige dosis var 10,05 mg. 
The mean average daily dose was 10.05 mg.
Der blev ikke set nogen virkning på vægt, højde og kønsudvikling efter op til 104 ugers behandling (n = 114). 
No effects on weight, height and sexual development were seen following up to 104 weeks of treatment (n = 114).
Personerne, der oplevede intolerable uønskede hændelser, kunne blive på den samme dosis, eller deres dosis kunne nedsættes til den tidligere tolererede dosis. 
Subjects experiencing intolerable adverse events could remain on the same dose or have their dose decreased to the previously tolerated dose.
Populationen omfattede 164 patienter (perampanel N=82, placebo N=82). 
The population included 164 patients (perampanel N = 82, placebo N = 82).
Generel støttebehandling af patienten er indiceret, herunder overvågning af vitale tegn og observation af patientens kliniske status. 
General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
- Fycompa kan gøre dig svimmel eller søvnig, især i begyndelsen af behandlingen. 
- Fycompa may make you feel dizzy or sleepy, particularly at the beginning of treatment.
I kombination med den manglende aldersrelaterede forskel i perampanel-eksponering indikerer resultaterne, at der ikke er behov for dosisjustering hos ældre. 
In combination with the lack of age-related difference in perampanel exposure, the results indicate that dose-adjustment in the elderly is not required.
Låget skal sættes på igen efter hver brug. 
The cap should be replaced after each use.
Kognitiv funktion 
Cognitive function
De fleste rapporterede hændelser var enten lette eller moderate, og patienterne kom i bedring enten spontant eller efter dosisjustering. 
Most of the reported events were either mild or moderate and patients recovered either spontaneously or with dose adjustment.
Lad være med at føre motorkøretøj eller betjene maskiner, indtil du ved, hvordan Fycompa påvirker dig. 
Do not drive or use machines until you know how Fycompa affects you.
Der er ingen tilgængelig specifik antidot mod virkningerne af perampanel. 
There is no available specific antidote to the effects of perampanel.
Disse virkninger kan også forekomme, når Fycompa anvendes i kombination med andre undertrykkere af centralnervesystemet (CNS). 
These effects may also be seen when Fycompa is used in combination with other central nervous system (CNS) depressants.
Virkningen af disse interaktioner på de gennemsnitlige steady-state koncentrationer opsummeres i den følgende tabel. 
The effect of these interactions on average steady state concentration is summarised in the following table.
Hvis dette forekommer, må du ikke føre motorkøretøj eller betjene værktøj eller maskiner. 
If this happens to you, do not drive or use any tools or machines.
Den kognitive funktion blev vurderet ved Cognitive Drug Research (CDR) System Global Cognition t-Score, som er en sammensat score afledt fra 5 domæner, der tester Power of Attention, Continuity of Attention, Quality of Episodic Secondary Memory, Quality of Working Memory, og Speed of Memory. 
Cognitive function was assessed by the Cognitive Drug Research (CDR) System Global Cognition t-Score, which is a composite score derived from 5 domains testing Power of Attention, Continuity of Attention, Quality of Episodic Secondary Memory, Quality of Working Memory, and Speed of Memory.
*Farvestofferne er: 
*The colourants are:
Ud af disse vendte 14 patienter (27 %) tilbage til tillægsbehandling i de følgende måneder. 
Of these, 14 patients (27%) reverted to adjunctive therapy in the following months.
Den præcise mekanisme, hvorved perampanel udøver sin antiepileptiske virkninger hos mennesker, mangler stadig at blive helt belyst. 
The precise mechanism by which perampanel exerts its antiepileptic effects in humans remains to be fully elucidated.
- Du må ikke tage mere Fycompa, end din læge har anbefalet. 
- Don't take more Fycompa than your doctor has recommended.
Tanker om at udøve skade på andre, fysiske overgreb eller truende adfærd blev imidlertid observeret hos nogle patienter (< 1 % i kliniske studier med perampanel). 
However, thoughts of harming others, physical assault or threatening behaviour were observed in some patients (<1% in perampanel clinical studies).
Ataksi Dysartri Balanceforstyrrelser Irritabilitet 
Dysarthria Balance disorder Irritability