FrancophonIA/ELRC3.0 huggingface dataset:
English: Eligible patients on a stable dose of 1 to 3 AEDs experiencing at least 3 primary generalised tonic-clonic seizures during the 8-week baseline period were randomised to either perampanel or placebo.
Icelandic: Sjúklingum sem uppfylltu skilyrði til inntöku í rannsóknina, voru á stöðugum skammti af 1 til 3 flogaveikilyfjum og fengu að minnsta kosti 3 þankippa-alflog á 8-vikna upphafstímabilinu var slembiraðað til að fá annaðhvort perampanel eða lyfleysu.
English: Felbamate has been shown to decrease the concentrations of some medicinal products and may also reduce perampanel concentrations.
Icelandic: Sýnt hefur verið fram á að felbamat lækkar blóðþéttni sumra lyfja og gæti einnig lækkað blóðþéttni perampanels.
English: Ten (10) patients were followed up for at least 18 months and, of these, 3 patients (30%) remained on perampanel monotherapy for at least 18 months.
Icelandic: 18 mánuði og af þeim héldu 3 sjúklingar (30%) áfram á einlyfjameðferð með perampaneli í a.m.k.
English: Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg film-coated tablets Perampanel
Icelandic: Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg og 12 mg filmuhúðaðar töflur Perampanel
English: Fycompa 2 mg, 4 mg film-coated tablets
Icelandic: Fycompa 2 mg, 4 mg filmuhúðaðar töflur
English: In the controlled Phase 3 primary generalised tonic-clonic seizures clinical trial, the rate of discontinuation as a result of an adverse reaction was 4.9% in patients randomised to receive perampanel 8 mg, and 1.2% in patients randomised to receive placebo.
Icelandic: 3. stigs samanburðarrannsókninni á frumkomnum þankippa-alflogum var tíðni þess að meðferð væri hætt vegna aukaverkana 4,9% hjá sjúklingum sem var slembiraðað og fengu 8 mg af perampaneli og 1,2% hjá sjúklingum sem fengu lyfleysu samkvæmt slembiröðun.
English: Fycompa should be taken as single oral dose at bedtime.
Icelandic: Fycompa á að taka inn í einum skammti fyrir svefn.
English: Perampanel should be taken orally once daily at bedtime.
Icelandic: Perampanel á að taka inn einu sinni á sólarhring fyrir svefn.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fycompa therapy taking into account the benefit of breast--feeding for the child and the benefit of therapy for the woman.
Icelandic: Vega þarf og meta kosti brjóstagjafar fyrir barnið og ávinning meðferðar fyrir konuna og ákveða á grundvelli matsins hvort hætta eigi brjóstagjöf eða hætta/stöðva tímabundið meðferð með Fycompa.
English: In a population pharmacokinetic analysis of the adolescent patients in the Phase 3 clinical studies, there were no notable differences between this population and the overall population.
Icelandic: Í greiningu á lyfjahvörfum sjúklinga á unglingsaldri í 3. stigs rannsóknunum kom ekki fram neinn munur á lyfjahvörfum hjá þeim og hjá sjúklingahópnum í heild.
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.
Icelandic: Í greiningu á lyfjahvörfum hópa sjúklinga með hlutaflog, sem höfðu kreatínínúthreinsun á bilinu 39 til 160 ml/mín. og fengu allt að 12 mg/sólarhring af perampaneli í klínískum samanburðarrannsóknum með lyfleysu, kom fram að kreatínínúthreinsun hafði ekki áhrif á úthreinsun perampanels.
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).
Icelandic: Með tilliti til einstaklingsbundinnar klínískrar svörunar og þols við 8 mg/sólarhring (16 ml/sólarhring) má auka skammtinn í allt að 12 mg/sólarhring (24 ml/sólarhring), sem getur haft verkun hjá sumum sjúklingum (sjá kafla 4.4).
English: 1) Active metabolite monohydroxycarbazepine was not assessed.
Icelandic: Virka umbrotsefnið einhýdroxýkarbazepín var ekki metið.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX22
Icelandic: Flogaveikilyf, önnur flogaveikilyf, ATC-flokkur:
English: 7 Turn upright and remove the oral syringe.
Icelandic: Snúið glasinu aftur við og losið munngjafarsprautuna.
English: The efficacy of perampanel in partial-onset seizures was established in three adjunctive therapy 19 week, randomised, double-blind, placebo-controlled, multicentre trials in adult and adolescent patients.
Icelandic: Sýnt var fram á verkun perampanels við hlutaflogum í þremur 19 vikna rannsóknum á viðbótarmeðferð sem gerðar voru hjá fullorðnum sjúklingum og unglingum.
English: Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS)
Icelandic: Alvarlegar aukaverkanir í húð (SCARs), þ.m.t. lyfjaútbrot með rauðkyrningageri og altækum einkennum (DRESS)
English: Excipient with known effect: Each 8 mg tablet contains 149.0 mg of lactose (as monohydrate).
Icelandic: Hver 8 mg tafla inniheldur 149,0 mg af laktósa (sem einhýdrat).
English: A 19-week, randomised, double-blind, placebo-controlled study with an open-label extension phase (Study 235) was performed to assess the short-term effects on cognition of Fycompa (target dose range of 8 to 12 mg once daily) as adjunctive therapy in 133 (Fycompa n = 85, placebo n = 48) adolescent patients, ages 12 to less than 18 years old, with inadequately controlled partial-onset seizures.
Icelandic: Nítján vikna, slembiröðuð, tvíblind samanburðarrannsókn með lyfleysu og opnum framhaldsfasa (rannsókn 235) var gerð til að meta skammtímaáhrif Fycompa á vitsmunastarfsemi (markskammtar voru á bilinu 8 til 12 mg einu sinni á sólarhring) sem viðbótarmeðferð hjá 133 (Fycompa n = 85, lyfleysa n = 48) sjúklingum á unglingsaldri, á aldrinum 12 til yngri en 18 ára, með hlutaflog sem ekki hefur náðst fullnægjandi stjórn á. Vitræn starfsemi var metin með t-skori úr prófinu „Cognitive Drug Research (CDR) System Global Cognition“, sem er samsett úr 5 prófum, „Power of Attention“, „Continuity of Attention“, „Quality of Episodic Secondary Memory“, „Quality of Working Memory“ og „Speed of Memory“.
English: What Fycompa contains
Icelandic: Fycompa inniheldur
English: Fycompa may make certain hormonal contraceptives such as levonorgestrel less effective.
Icelandic: Fycompa getur dregið úr áhrifum tiltekinna getnaðarvarnartaflna svo sem levónorgestrels.
English: Each ml contains 0.5 mg perampanel.
Icelandic: Hver ml inniheldur 0,5 mg af perampaneli.
English: Oxcarbazepine is rapidly metabolised by cytosolic reductase enzyme to the active metabolite, monohydroxycarbazepine.
Icelandic: Oxkarbazepín umbrotnar hratt fyrir tilstilli afoxunarensíms í umfrymi yfir í virka umbrotsefnið einhýdroxýcarbazepín.
English: Dysarthria Balance disorder Irritability
Icelandic: Taltruflanir Jafnvægistruflanir Pirringur
English: Conversion to monotherapy
Icelandic: Skipt yfir í einlyfjameðferð
English: Perampanel is extensively metabolised via primary oxidation and sequential glucuronidation.
Icelandic: Perampanel umbrotnar ítarlega við oxun og glúkúróníðraðtengingu.
English: In vitro studies show that perampanel is not a substrate or significant inhibitor of organic anion transporting polypeptides (OATP) 1B1 and 1B3, organic anion transporters (OAT) 1, 2, 3, and 4,
Icelandic: In vitro rannsóknir sýna að perampanel er ekki hvarfefni eða marktækur hemill á lífræn anjónaflutningsfjölpeptíð (e. organic anion transporting polypeptides (OATP))
English: Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate receptor on post-synaptic neurons.
Icelandic: Perampanel er fyrsta lyfið í sínum flokki sem er sértækur blokki, sem ekki er samkeppnisblokki, á jónaganga α-amínó-3-hýdroxý-5-metýl-4-ísoxazólprópíónsýru (AMPA) glútamat viðtakann á taugafrumum handan taugamóta.
English: It comes in a bottle of 340 ml with 2 graduated oral syringes and an LDPE press-in bottle adapter (PIBA).
Icelandic: Hún er afgreidd í glasi sem inniheldur 340 ml, ásamt tveimur kvörðuðum munngjafarsprautum og lágþéttnipólýetýlen (LDPE) millistykki.
English: The administration of maximum tolerated doses to rats and monkeys resulted in pharmacologically-based CNS clinical signs and decreased terminal body weight.
Icelandic: Þegar rottum og öpum voru gefnir hámarksskammtar sem þoldust komu fram lyfjafræðileg áhrif á miðtaugakerfið með klínískum einkennum og minnkaðri líkamsþyngd við lok rannsóknar.
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).
Icelandic: Með tilliti til einstaklingsbundinnar klínískrar svörunar og þols við 8 mg/sólarhring (16 ml/sólarhring) má auka skammtinn um 2 mg/sólarhring (4 ml/sólarhring) í einu, í 12 mg/sólarhring (24 ml/sólarhring).
English: Alertness and mood
Icelandic: Árvekni og hugarástand
English: Partial-Onset Seizures
Icelandic: Tafla yfir aukaverkanir
English: Orange, round, biconvex tablet, engraved with E275 on one side and ‘2' on other side
Icelandic: Appelsínugul, kringlótt, tvíkúpt tafla, auðkennd með E275 á annarri hliðinni og „2“ á hinni
English: Red, round, biconvex tablet, engraved with E277 on one side and ‘4' on other side
Icelandic: Rauð, kringlótt, tvíkúpt tafla, auðkennd með E277 á annarri hliðinni og „4“ á hinni
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Icelandic: Lýsing á útliti Fycompa og pakkningastærðir
English: - Some other medicines such as rifampicin (a medicine used to treat bacterial infections),
Icelandic: - Sum önnur lyf svo sem rífampicín (lyf til meðferðar við bakteríusýkingum) og hýpericum
English: 4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets - packs of 7, 28, 84 and 98
Icelandic: 2 mg tafla - pakkning með 7, 28 eða 98 töflum 4 mg, 6 mg, 8 mg, 10 mg og 12 mg töflur - pakkningar með 7, 28, 84 eða 98 töflum
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).
Icelandic: Með tilliti til einstaklingsbundinnar klínískrar svörunar og þols við 8 mg/sólarhring má auka skammtinn í allt að 12 mg/sólarhring, sem getur haft verkun hjá sumum sjúklingum (sjá kafla 4.4).
English: 1.9 fold decrease
Icelandic: Oxkarbazepín 1,9-föld lækkun
English: After first opening: 90 days.
Icelandic: 90 dagar.
English: 2 mg tablet: Ferric Oxide, Yellow (E172), Ferric Oxide, Red (E172) 4 mg tablet: Ferric Oxide, Red (E172)
Icelandic: Járnoxíð, gult (E172), járnoxíð, rautt (E172) 4 mg tafla:
English: In addition, a pharmacokinetic-pharmacodynamic (efficacy) analysis was performed in one efficacy trial for primary generalised tonic-clonic seizures.
Icelandic: Að auki var gerð lyfjahvarfa- og lyfhrifagreining (verkun) í einni rannsókn á verkun gegn frumkomnum þankippa-alflogum.
English: Phenobarbital
Icelandic: Fenóbarbítal
English: Green, round, biconvex tablet, engraved with E296 on one side and ‘10' on other side
Icelandic: Græn, kringlótt, tvíkúpt tafla, auðkennd með E296 á annarri hliðinni og „10“ á hinni
English: Patients should be up-titrated using 2 mg (4 ml) doses no faster than every 2 weeks based on tolerability and effectiveness.
Icelandic: Títra skal skammtinn upp um 2 mg (4 ml) í einu með að minnsta kosti 2 vikna millibili og taka skal mið af þoli sjúklingsins og verkun lyfsins.
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.
Icelandic: Í greiningu á lyfjahvörfum hjá hópum sjúklinga með hlutaflog, sem fengu allt að 12 mg/sólarhring og sjúklingum með frumkomin þankippa-alflog sem fengu allt að 8 mg/sólarhring af perampaneli í klínískum samanburðarrannsóknum með lyfleysu, reyndist vera línulegt samband á milli skammta og plasmaþéttni perampanels.
English: Fycompa 2 mg film-coated tablets Fycompa 4 mg film-coated tablets Fycompa 6 mg film-coated tablets Fycompa 8 mg film-coated tablets Fycompa 10 mg film-coated tablets Fycompa 12 mg film-coated tablets
Icelandic: Fycompa 2 mg filmuhúðaðar töflur Fycompa 4 mg filmuhúðaðar töflur
English: Valproic Acid No influence
Icelandic: Klóbazam Engin áhrif
English: Perampanel is readily absorbed after oral administration with no evidence of marked first-pass metabolism.
Icelandic: Perampanel frásogast greiðlega eftir inntöku án þess að nokkuð bendi til umtalsverðra umbrota við fyrstu umferð um lifur.
English: Nervous system disorders
Icelandic: Sjúkdómar í taugakerfi
English: General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
Icelandic: Veita skal sjúklingum almenna stuðningsmeðferð, þar með talið eftirlit með lífsmörkum og klínísku ástandi.
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).
Icelandic: Í greiningu á lyfjahvörfum hópa sjúklinga með hlutaflog sem fengu allt að 12 mg/sólarhring af perampaneli og sjúklinga með frumkomin þankippa-alflog sem fengu allt að 8 mg/sólarhring í klínískum samanburðarrannsóknum með lyfleysu var úthreinsun perampanels hjá konum (0,54 l/klst.)
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Icelandic: Aukaverkanir sem ekki komu fram í klínískum rannsóknum en sáust hjá dýrum við skömmtun sem er svipuð meðferðarskömmtun og skipta hugsanlega máli við klíníska notkun voru sem hér segir:
English: The oral syringe should be inserted into the PIBA and the dose withdrawn from the inverted bottle.
Icelandic: Stinga skal munngjafarsprautunni í millistykkið, hvolfa glasinu og draga skammtinn úr glasinu.
English: Fycompa is not recommended during pregnancy.
Icelandic: Fycompa er ekki ætlað til notkunar á meðgöngu.
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.
Icelandic: Svipuð niðurstaða kom fram við greiningu á lyfjahvörfum hjá hópum sjúklinga með hlutaflog sem fengu allt að 12 mg/sólarhring af perampaneli og sjúklingum með frumkomin þankippa-alflog sem fengu allt að 8 mg/sólarhring í klínískum samanburðarrannsóknum með lyfleysu.
English: Zonisamide
Icelandic: Zónisamíð
English: Each film-coated tablet contains 8 mg perampanel.
Icelandic: Hver filmuhúðuð tafla inniheldur 8 mg af perampaneli.
English: Date of first authorisation: 23/07/2012 Date of latest renewal: 6 April 2017
Icelandic: 6. apríl 2017.
English: Influence of AED on Fycompa concentration
Icelandic: Áhrif annarra flogaveikilyfja á blóðþéttni Fycompa
English: Excipient with known effect: Each 10 mg tablet contains 147.0 mg of lactose (as monohydrate).
Icelandic: Hver 10 mg tafla inniheldur 147,0 mg af laktósa (sem einhýdrat).
English: Perampanel oral suspension is bioequivalent on a mg per mg basis to perampanel tablets under fasted conditions.
Icelandic: Perampanel mixtúra, dreifa er jafngild (e. bioequivalent) perampanel töflum þ.e. mg á mg, á fastandi maga.
English: Pink, round, biconvex tablet, engraved with E294 on one side and ‘6' on other side
Icelandic: Bleik, kringlótt, tvíkúpt tafla, auðkennd með E294 á annarri hliðinni og „6“ á hinni
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).
Icelandic: Auka má skammtinn með tilliti til klínískrar svörunar og þols smám saman um 2 mg (4 ml) í einu (annaðhvort vikulega eða á 2 vikna fresti eftir því sem við á m.t.t. helmingunartíma eins og lýst er hér á eftir) í allt að 4 mg/sólarhring (8 ml/sólarhring) til 8 mg/sólarhring (16 ml/sólarhring) viðhaldsskammt.
English: Each tablet contains 8 mg perampanel.
Icelandic: Hver tafla inniheldur 8 mg af perampaneli.
English: If you have taken more Fycompa than you should contact your doctor straight away.
Icelandic: Ef tekinn er stærri skammtur en mælt er fyrir um Ef þú hefur tekið meira af Fycompa en mælt er fyrir um áttu að hafa samband við lækni án tafar.
English: Film coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets) Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), colourants*
Icelandic: Hýprómellósi 2910, talkúm, makrógól 8000, títantvíoxíð (E171), litarefni*
English: Excipient with known effect: Each 6 mg tablet contains 151.0 mg of lactose (as monohydrate).
Icelandic: Hver 6 mg tafla inniheldur 151,0 mg af laktósa (sem einhýdrat).
English: Blue, round, biconvex tablet, engraved with E297 on one side and ‘12' on other side
Icelandic: Blá, kringlótt, tvíkúpt tafla, auðkennd með E297 á annarri hliðinni og „12“ á hinni
English: 2 oral syringes
Icelandic: 6.2 Ósamrýmanleiki
English: Perampanel is dosed to clinical effect regardless of other AEDs.
Icelandic: Perampanel er skammtað þar til klínískri verkun er náð án tillits til annarra flogaveikilyfja.
English: Cognitive function
Icelandic: KLÍNÍSKAR UPPLÝSINGAR
English: In a healthy volunteer study to assess the effects of perampanel on alertness, and memory using a standard battery of assessments, no effects of perampanel were found following single and multiple doses of perampanel up to 12 mg/day.
Icelandic: Í rannsókn sem gerð var hjá heilbrigðum sjálfboðaliðum til þess að meta áhrif perampanels á árvekni og minni var notuð röð staðlaðra prófana.
English: Excipient with known effect: Each 12 mg tablet contains 145.0 mg of lactose (as monohydrate).
Icelandic: Hver 12 mg tafla inniheldur 145,0 mg af laktósa (sem einhýdrat).
English: Turn upside down and withdraw the prescribed amount of Fycompa from the bottle.
Icelandic: Hvolfið glasinu og dragið ávísað magn af Fycompa úr glasinu.
English: Purple, round, biconvex tablet, engraved with E295 on one side and ‘8' on other side
Icelandic: Fjólublá, kringlótt, tvíkúpt tafla, auðkennd með E295 á annarri hliðinni og „8“ á hinni
English: NAME OF THE MEDICINAL PRODUCT
Icelandic: Notkun eftir markaðssetningu lyfsins
English: The cap should be replaced after each use.
Icelandic: Setja skal lokið á glasið eftir hverja notkun.
English: Excipient with known effect: Each 4 mg tablet contains 157.0 mg of lactose (as monohydrate).
Icelandic: Hver 4 mg tafla inniheldur 157,0 mg af laktósa (sem einhýdrat).
English: There appears to be an increased risk of falls, particularly in the elderly; the underlying reason is unclear.
Icelandic: Svo virðist sem aukin hætta sé á byltum, sérstaklega hjá öldruðum.
English: Fycompa contains sorbitol
Icelandic: Fycompa inniheldur sorbitól
English: Open label extension study
Icelandic: Opin framhaldsrannsókn
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).
Icelandic: Í slíkum tilvikum er mælt með notkun annarra getnaðarvarna sem ekki byggja á hormónum meðan á meðferð með Fycompa stendur (sjá kafla 4.5).
English: Topiramate
Icelandic: Verkunarháttur
English: Fycompa 8 mg film-coated tablets
Icelandic: Fycompa 8 mg filmuhúðaðar töflur
English: Titanium dioxide (E171) Ferric oxide, red (E172)
Icelandic: Títantvíoxíð (E171) Járnoxíð, rautt (E172)
English: Titanium dioxide (E171) Ferric oxide, yellow (E172) Ferric oxide, red (E172)
Icelandic: Títantvíoxíð (E171) Járnoxíð, gult (E172) Járnoxíð, rautt (E172)
English: Primary Generalised Tonic-Clonic Seizures
Icelandic: Klínískt mikilvæg lækkun
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.
Icelandic: Í öllum þremur rannsóknunum var einstaklingunum slembiraðað og skammtar stilltir að slembiröðuðum skammti, eftir að 6-vikna upphafsfasanum lauk, þar sem tíðni floga var metin áður en slembiröðun fór fram.
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.
Icelandic: Í greiningu á lyfjahvörfum hópa sjúklinga með frumkomin þankippa-alflog, sem fengu allt að 8 mg/sólarhring af perampaneli í klínískum samanburðarrannsóknum með lyfleysu, kom fram að kreatínínúthreinsun í upphafi hafði ekki áhrif á úthreinsun perampanels.
English: Each tablet contains 4 mg perampanel.
Icelandic: Hver tafla inniheldur 4 mg af perampaneli.
English: In vitro assessment of drug interactions
Icelandic: In vitro prófanir á milliverkunum lyfja
English: Each tablet contains 12 mg perampanel.
Icelandic: Hver tafla inniheldur 12 mg af perampaneli.
English: Each film-coated tablet contains 12 mg perampanel.
Icelandic: Hver filmuhúðuð tafla inniheldur 12 mg af perampaneli.
English: Each film-coated tablet contains 2 mg perampanel.
Icelandic: Hver filmuhúðuð tafla inniheldur 2 mg af perampaneli.
English: Between 85.3% and 89.1% of patients were taking two to three concomitant AEDs with or without concurrent vagal nerve stimulation.
Icelandic: Í þessum þremur rannsóknum var meðaltíminn sem einstaklingar höfðu haft flogaveiki 21,06 ár. Á bilinu 85,3% til 89,1% sjúklinga voru á samhliða meðferð með tveimur til þremur flogaveikilyfjum með eða án samhliða örvunar skreyjutaugar.
English: Fycompa 8 mg film-coated tablets 8 mg - packs of 7, 28, 84 and 98
Icelandic: Fycompa 8 mg filmuhúðaðar töflur 8 mg - pakkningar með 7, 28, 84 eða 98 töflum
English: Post-marketing use
Icelandic: MARKAÐSLEYFISNÚMER
English: In vivo, perampanel significantly prolonged seizure latency in an AMPA-induced seizure model.
Icelandic: In vivo lengdi perampanel marktækt þann tíma sem engin flog áttu sér stað í AMPA-örvuðu flogalíkani.
English: Each tablet contains 2 mg perampanel.
Icelandic: Hver tafla inniheldur 2 mg af perampaneli.
English: Perampanel at a dose up to 8 mg/day has been shown to be effective in primary generalised tonic-clonic seizures.
Icelandic: Sýnt hefur verið fram á að perampanel í skömmtum sem eru allt að 8 mg/sólarhring veitir virka meðferð við frumkomnum þankippa-alflogum.
English: Each film-coated tablet contains 10 mg perampanel.
Icelandic: Hver filmuhúðuð tafla inniheldur 10 mg af perampaneli.
English: The mean apparent clearance of unbound perampanel in mildly impaired subjects was 188 ml/min vs. 338 ml/min in matched controls, and in moderately impaired subjects was 120 ml/min vs. 392 ml/min in matched controls.
Icelandic: Sýnileg úthreinsun óbundins perampanels hjá einstaklingum með væga skerðingu á lifrarstarfsemi var að meðaltali 188 ml/mín. samanborið við 338 ml/mín.
English: Each tablet contains 6 mg perampanel.
Icelandic: Hver tafla inniheldur 6 mg af perampaneli.
English: A pharmacokinetic-pharmacodynamic (efficacy) analysis was performed based on the pooled data from the 3 efficacy trials for partial-onset seizures.
Icelandic: Greining var gerð á lyfjahvörfum-lyfhrifum (verkun) á grundvelli samantekinna upplýsinga úr rannsóknunum þremur sem gerðar voru m.t.t. hlutafloga.
English: Each tablet contains 10 mg perampanel.
Icelandic: Hver tafla inniheldur 10 mg af perampaneli.