natgillin/translations-raw huggingface dataset:
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
Forberedelse: Press-in-bottle-adapteren (PIBA), som leveres i præparatets æske, skal sættes godt fast i flaskehalsen før brug og skal blive på plads, mens flaskes bruges.
Preparation: The press-in-bottle adapter (PIBA) which is supplied in the product carton should be inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage of the bottle.
Glutamat er den primære eksitatoriske neurotransmitter i centralnervesystemet, og det er impliceret i flere neurologiske sygdomme forårsaget af neuronal overeksitering.
Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal overexcitation.
Indsæt den orale sprøjte så langt ind i adapteren åbning som muligt.
Insert the oral syringe into the opening of the adaptor as far as possible.
- Du skal bruge en pålidelig præventionsmetode for at undgå at blive gravid, mens du behandles med Fycompa.
- You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Fycompa.
Der var ingen statistisk signifikant forskel mellem behandlingsgrupperne (p = 0,145).
There was no statistically significant difference between the treatment groups (p = 0.145).
Hvis du f.eks. vælger at tage Fycompa sammen med mad, skal du altid tage det på denne måde.
For example, if you decide to take Fycompa with food, always take it that way.
Personerne havde partielle anfald med eller uden sekundær generalisering, og var ikke tilstrækkeligt kontrollerede med en til tre samtidige AED'er.
Subjects had partial-onset seizures with or without secondary generalisation and were not adequately controlled with one to three concomitant AEDs.
Der var ingen ændringer, der direkte kunne tilskrives perampanel, i klinisk patologi eller histopatologi.
There were no changes directly attributable to perampanel in clinical pathology or histopathology.
Anvisninger i, hvordan den orale sprøjte og adapteren anvendes, gives herunder:
Instructions on how to use the oral syringe and adaptor are provided below:
Disse data var i overensstemmelse med data for den procentvise ændring i anfaldshyppighed og viste, at for PGTG var 50 %-responsraten generelt stabil i tidsperioden fra ca. uge 26 til og med slutningen af år 2.
These data were consistent with those for percent change in seizure frequency and showed that the PGTC 50% responder rate was generally stable across time from about week 26 through the end of year 2.
Det menes, at aktivering af AMPA-receptorerne med glutamat er ansvarlig for de fleste hurtige eksitatoriske synaptiske transmissioner i hjernen.
Activation of AMPA receptors by glutamate is thought to be responsible for most fast excitatory synaptic transmission in the brain.
Data fra in vitro-studier indikerer, at perampanel er ca. 95 % bundet til plasmaproteiner.
Data from in vitro studies indicate that perampanel is approximately 95% bound to plasma proteins.
Lignende resultater blev observeret, når alle anfald og absencer versus myokloniske anfald blev evalueret over tid.
Similar results were seen when all seizures and absence vs. myoclonic seizures were evaluated over time.
Et lille antal personer, der behandles med antiepileptika, har tænkt på at gøre skade på dem selv eller begå selvmord.
A small number of people being treated with anti-epileptics have had thoughts of harming or killing themselves.
På grund af den lange halveringstid og den efterfølgende langsomme reduktion i plasmakoncentration kan perampanel dog seponeres pludseligt, hvis det er absolut nødvendigt.
However, due to its long half-life and subsequent slow decline in plasma concentrations, perampanel can be discontinued abruptly if absolutely needed.
Fycompa er til oral anvendelse.
Fycompa is for oral use.
Mellem 85,3 % og 89,1 % af patienterne tog to til tre samtidige AED'er med eller uden samtidig stimulation af vagusnerven.
Between 85.3% and 89.1% of patients were taking two to three concomitant AEDs with or without concurrent vagal nerve stimulation.
Virkning af perampanel på CYP3A-substrater
Effect of perampanel on CYP3A substrates
Efter op til 52 ugers behandling med perampanel (n = 114) blev der ikke observeret nogen virkning på knoglevæksten.
After up to 52 weeks of treatment with perampanel (n = 114), no effect on bone growth was observed.
<10 % reduktion
<10% decrease
Udskillelse i mælken hos dyr blev målt hos rotter 10 dage post-partum.
The excretion into breast milk was measured in rats at 10 days post-partum.
I disse tre studier havde personerne en gennemsnitlig epilepsivarighed på ca. 21,06 år.
In these three trials, subjects had a mean duration of epilepsy of approximately 21.06 years.
Det tilhører en gruppe af lægemidler, der kaldes antiepileptika.
It belongs to a group of medicines called anti-epileptics.
Graviditet og amning Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slug tabletten hel sammen med et glas vand.
Swallow the tablet whole with a glass of water.
En enkelt glemt dosis: Da perampanel har en lang halveringstid, bør patienten vente og tage den næste dosis som planlagt.
Single missed dose: As perampanel has a long half-life, the patient should wait and take their next dose as scheduled.
En større reduktion i eksponeringen over for midazolam (eller andre følsomme CYP3Asubstrater) ved højere doser af Fycompa kan ikke udelukkes.
A larger decrease in exposure of midazolam (or other sensitive CYP3A substrates) at higher Fycompa doses cannot be excluded.
Hvis du på noget tidspunkt har sådanne tanker, skal du straks kontakte lægen.
If at any time you have these thoughts, contact your doctor straight away.
Der er begrænset klinisk erfaring med en overdosering af perampanel hos mennesker.
There is limited clinical experience with perampanel overdose in humans.
Hvis der opstår tegn eller symptomer, som tyder på sådanne reaktioner, bør perampanel omgående seponeres, og en alternativ behandling bør overvejes (efter behov).
If signs and symptoms suggestive of these reactions appear, perampanel should be withdrawn immediately and an alternative treatment considered (as appropriate).
AUC for ethinyløstradiol blev ikke påvirket af Fycompa 12 mg, hvorimod Cmax blev reduceret med 18 %.
Ethinylestradiol AUC was not affected by Fycompa 12 mg whereas Cmax was decreased by 18%.
Den adfærdsmæssige udvikling og reproduktionsudviklingen hos afkommet var ikke påvirket, men nogle parametre for fysisk udvikling viste nogen forsinkelse, som sikkert er sekundær til de farmakologi-baserede CNS-virkninger af perampanel.
Behavioural and reproductive development of the offspring was not affected, but some parameters of physical development showed some delay, which is probably secondary to the pharmacology-based CNS effects of perampanel.
Clonazepam Ingen indflydelse
Clonazepam No influence
Hvis du får noget af det ovenstående, efter du tager Fycompa (eller du ikke er sikker), skal du tale med din læge eller apoteket.
If you experience any of the above after taking Fycompa (or you are not sure) talk to your doctor or pharmacist.
I en rapport om en tilsigtet overdosering, der kunne have resulteret i en dosis på op til 264 mg, oplevede patienten hændelser med ændret psykisk status, ophidselse og aggressiv adfærd og kom sig uden sequelae.
In a report of an intentional overdose that could have resulted in a dose up to 264 mg, the patient experienced events of altered mental status, agitation and aggressive behaviour and recovered without sequelae.
Carbamazepin, en kendt potent enzyminduktor, reducerede perampanel-niveauerne med to tredjedele i et studie, der blev udført med raske personer.
Carbamazepine, a known potent enzyme inducer, reduced perampanel levels by two-thirds in a study performed on healthy subjects.
Patienternes respons bør overvåges, når de skiftes fra samtidige ikke-inducerende antiepileptika til enzyminducerende lægemidler og omvendt.
Patients' response should be monitored when they are switching from concomitant non-inducer anti-epileptic medicinal products to enzyme inducing medicinal products and vice versa.
Administrationen af maksimalt tolererede doser til rotter og aber resulterede i farmakologisk baserede kliniske CNS-tegn og nedsat terminal kropsvægt.
The administration of maximum tolerated doses to rats and monkeys resulted in pharmacologically-based CNS clinical signs and decreased terminal body weight.
Farmakoterapeutisk klassifikation; Antiepileptika, andre antiepileptika, ATC-kode: N03AX22
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX22
Du må ikke starte eller stoppe med at tage andre lægemidler uden at tale med lægen eller apotekspersonalet.
Do not start or stop other medicines without talking to your doctor or pharmacist.
Tryk låget ned, og drej det for at åbne flasken.
Push down and turn cap to open bottle.
Perampanel doseres til klinisk virkning uanset andre AED'er.
Perampanel is dosed to clinical effect regardless of other AEDs.
Det anbefales, at seponering foretages gradvist for at minimere risikoen for recidiverende epilepsianfald.
It is recommended that discontinuation be undertaken gradually to minimise the potential for rebound seizures.
Mulighed for misbrug
Abuse potential
I alle tre studier blev titreringsfasen efterfulgt af en vedligeholdelsesfase, der varede 13 uger, hvor patienterne skulle blive på en stabil dosis af perampanel.
In all three trials, the Titration Phase was followed by a Maintenance Phase that lasted 13 weeks, during which patients were to remain on a stable dose of perampanel.
Det er blevet vist, at felbamat reducerer koncentrationen af nogle lægemidler og kan muligvis også reducere perampanelkoncentrationen.
Felbamate has been shown to decrease the concentrations of some medicinal products and may also reduce perampanel concentrations.
Kliniske studier af epilepsi med Fycompa omfattede ikke et tilstrækkeligt antal personer, i alderen fra 65 år til at bestemme om de responderede anderledes end yngre personer.
Clinical studies of Fycompa in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Perampanels sikkerhed og virkning hos børn under 12 år er endnu ikke klarlagt.
The safety and efficacy of perampanel in children below 12 years of age have not been established yet.
Tabletten skal sluges hel sammen med et glas vand.
The tablet should be swallowed whole with a glass of water.
I urin og fæces bestod den genfundne radioaktivitet primært af en blanding af oxidative og konjugerede metabolitter.
In urine and faeces, recovered radioactivity was primarily composed of a mixture of oxidative and conjugated metabolites.
Eisai Manufacturing Ltd. European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN Storbritannien
Eisai Manufacturing Ltd. European Knowledge Centre Mosquito Way Hatfield, Herts AL10 9SN United Kingdom
Vær forsigtig, hvis du indtager alkohol sammen med epilepsimedicin, herunder Fycompa.
Be careful about consuming alcohol with epilepsy medicines including Fycompa.
Du har fået det af din læge for at reducere antallet af dine anfald.
It has been given to you by your doctor to reduce the number of fits that you have.
Hvis en patient har afbrudt perampanel i en sammenhængende periode på over 5 halveringstider, anbefales det, at de indledende doseringsanbefalinger, der beskrives ovenfor, følges.
If a patient has discontinued perampanel for a continuous period of more than 5 half-lives, it is recommended that initial dosing recommendations given above should be followed.
Analyse af sikkerhedsinformation hos 905 perampanelbehandlede ældre personer (i dobbeltblinde studier af ikkeepileptiske indikationer) afslørede ingen aldersrelaterede forskelle i sikkerhedsprofil.
Analysis of safety information in 905 perampanel-treated elderly subjects (in double-blind studies conducted in non-epilepsy indications) revealed no age-related differences in the safety profile.
Kvinder i den fertile alder og kontraception hos mænd og kvinder
Women of childbearing potential and contraception in males and females
Dato for åbning:
Open date:
Denne virkning skal tages med i overvejelserne og behandles, når disse antiepileptika tilføjes eller seponeres fra patientens behandlingsprogram.
This effect should be taken into account and managed when adding or withdrawing these anti-epileptic drugs from a patient's treatment regimen.
Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisteren.
Do not use this medicine after the expiry date which is stated on the carton and blister.
Antallet af personer, der fik perampanel og tog enzyminducerende antiepileptika, var lille (n=9).
The number of perampanel subjects taking enzyme-inducing anti-epileptic medicinal products was small (n = 9).
Det frarådes, at patienterne fører motorkøretøj, betjener komplicerede maskiner eller foretager andre potentielt farlige aktiviteter, indtil det vides, om perampanel påvirker deres evne til at udføre disse opgaver (se pkt.
Patients are advised not to drive a vehicle, operate complex machinery or engage in other potentially hazardous activities until it is known whether perampanel affects their ability to perform these tasks (see sections 4.4 and 4.5).
Fycompa indeholder lactose (en form for sukker).
Fycompa contains lactose (a type of sugar).
19 % reduktion
19% decrease
Den sædvanlige startdosis er 2 mg én gang dagligt, før du går i seng.
The usual starting dose is 2 mg once a day before you go to bed.
De tre pivotale dobbeltblinde placebokontrollerede fase 3-studier inkluderede 143 unge fra 12 til 18 år.
The three pivotal double-blind placebo-controlled phase 3 studies included 143 adolescents between the ages of 12 and 18.
Derfor skal patienterne overvåges for tegn på selvmordstanker og -adfærd, og der skal overvejes hensigtsmæssig behandling.
Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
- Hvis du har lette eller moderate leverproblemer, bør din dosis ikke overstige 8 mg dagligt, og der skal være mindst 2 uger mellem dine dosisforhøjelser.
- If you have mild or moderate liver problems, your dose should not be more than 8 mg each day and your dose increases should be at least 2 weeks apart.
Dosisjustering anses ikke for at være nødvendig hos ældre (se pkt.
A dose adjustment in the elderly is not considered to be necessary (see section 4.2).
Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Storbritannien
Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom
I løbet af en 6-ugers baselineperiode skulle personerne have over fem epilepsianfald og ingen anfaldsfri periode længere end 25 dage.
During a 6-week baseline period, subjects were required to have more than five seizures with no seizure-free period exceeding 25 days.
Brug ikke lægemidlet efter den udløbsdato, der står på flaskens etiket og kartonen.
Do not use this medicine after the expiry date which is stated on the bottle label and carton.
Indeholder sorbitol: Læs indlægssedlen for yderligere information.
Contains sorbitol: see leaflet for further information.
Der bør udvises forsigtighed, hvis Fycompa oral suspension kombineres med andre antiepileptika indeholdende sorbitol, da en kombineret indtagelse på over 1 gram sorbitol kan påvirke absorptionen af nogle lægemidler.
Caution should be exercised when combining Fycompa oral suspension with other antiepileptic medications containing sorbitol, since a combined intake of over 1 gram of sorbitol may affect absorption of some drugs.
Hovedparten af disse patienter havde partielle anfald i anamnesen.
The majority of these patients had a history of partial onset seizures.
Patienterne blev titreret til en måldosis på 8 mg dagligt eller den højeste tolererede dosis i løbet af fire uger og behandlet i yderligere 13 uger med det sidste dosisniveau, der blev opnået ved slutningen af titreringsperioden.
Patients were titrated over four weeks to a target dose of 8 mg per day or the highest tolerated dose and treated for an additional 13 weeks on the last dose level achieved at the end of the titration period.
Når den lange halveringstid tages med i overvejelserne, kan de virkninger, der forårsages af perampanel, være langvarige.
In view of its long half-life, the effects caused by perampanel could be prolonged.
Fycompa bør ikke anvendes til børn under 12 år.
Fycompa is not recommended for children aged under 12.
Efter administration af en radioaktivt mærket perampanel-dosis til enten 8 raske voksne eller ældre personer blev ca. 30 % af den genfundne radioaktivitet fundet i urinen og 70 % i fæces.
Following administration of a radiolabeled perampanel dose to either 8 healthy adults or elderly subjects, approximately 30% of recovered radioactivity was found in the urine and 70% in the faeces.
PVC/aluminiumblisters
PVC/aluminium blisters
Fycompa skal tages som en enkelt oral dosis ved sengetid.
Fycompa should be taken as single oral dose at bedtime.
Den kan tages sammen med eller uden mad (se pkt.
It may be taken with or without food (see section 5.2).
Vend på hovedet, og træk den ordinerede mængde Fycompa ud af flasken.
Turn upside down and withdraw the prescribed amount of Fycompa from the bottle.
Fycompa bør ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception, medmindre det er klart nødvendigt.
Fycompa is not recommended in women of childbearing potential not using contraception unless clearly necessary.
Perampaneldosis bør reduceres, hvis sådanne symptomer opstår, og perampanel bør straks seponeres, hvis symptomerne er svære.
The dosage of perampanel should be reduced if such symptoms occur and should be discontinued immediately if symptoms are severe.
På grund af den lave renale clearance er det usandsynligt, at særlige indgreb, såsom forceret dialyse eller hæmoperfusion, er nyttige.
Because of low renal clearance special interventions such as forced diuresis, dialysis or haemoperfusion are unlikely to be of value.