FrancophonIA/ELRC3.0 huggingface dataset:
English: Perampanel did not prolong the QTc interval when administered in daily doses up to 12 mg/day, and did not have a dose-related or clinically important effect on QRS duration.
Maltese: Perampanel ma tawwalx l-intervall tal-QTc meta ngħata f'dożi ta' kuljum sa 12 mg/kuljum, u ma kellux effett relatat mad-doża jew effett klinikament importanti fuq it-tul ta' QRS.
English: 1 bottle (340 ml) contains 170 mg perampanel.
Maltese: Kull ml fih 0.5 mg ta' perampanel. 1 flixkun (340 ml) fih 170 mg ta' perampanel.
English: Between 85.3% and 89.1% of patients were taking two to three concomitant AEDs with or without concurrent vagal nerve stimulation.
Maltese: 3% u 89.1% tal-pazjenti kienu qed jieħdu tnejn jew tlett AEDs fl-istess ħin bi jew mingħajr stimulazzjoni tan-nervi vagali fl-istess ħin.
English: There were no changes directly attributable to perampanel in clinical pathology or histopathology.
Maltese: Ma kienx hemm tibdil attribwibbli direttament għal perampanel fil-patoloġija klinika jew istopatoloġija.
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.
Maltese: 338 ml/min f'kontrolli mqabbla, u f'persuni b'indeboliment moderat kien ta' 120 ml/min vs.
English: The median percent change in primary generalised tonic-clonic seizure frequency per 28 days during the Titration and Maintenance Periods (combined) relative to Prerandomisation was greater with perampanel (-76.5%) than with placebo (-38.4%), P < 0.0001.
Maltese: Il-medjan tal-bidla perċentwali fil-frekwenza ta' aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji għal kull 28 jum matul il-Perjodi ta' Titrazzjoni u Manteniment (kombinati) fir-rigward tal-Perjodu ta' qabel l-għażla każwali, kien akbar b'perampanel (-76.5%) milli bil-plaċebo (-38.4%), P<0.0001.
English: 2 mg tablet - pack of 7, 28 and 98
Maltese: Pillola ta' 2 mg - pakkett ta' 7, 28 u 98
English: Severe cutaneous adverse reactions (SCARs) including drug reaction with eosinophilia and systemic symptoms (DRESS)
Maltese: Reazzjonijiet avversi severi tal-ġilda (SCARs, severe cutaneous adverse reactions) li jinkludu reazzjoni tal-mediċina b'eosinofilija u sintomi sistemiċi (DRESS, drug reaction with eosinophilia and systemic symptoms)
English: Each film-coated tablet contains 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, or 12 mg perampanel.
Maltese: Kull pillola miksija b'rita fiha 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, jew 12 mg ta' perampanel.
English: 7 film-coated tablets 28 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Maltese: 7 pilloli miksija b'rita 28 pillola miksija b'rita 84 pillola miksija b'rita 98 pillola miksija b'rita
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.
Maltese: 1.7 sa 5.8% tal-pazjenti li kienu qed jieħdu perampanel fl-istudji kliniċi, ma kellhom l-ebda aċċessjoni matul il-perjodu ta' manteniment ta' 3 xhur meta mqabbla ma' 0% -1.0% tal-pazjenti li kienu qed jieħdu plaċebo.
English: In a population pharmacokinetic analysis of pooled data from 19 Phase 1 studies, the average t½ of perampanel was 105 hours.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' dejta miġbura minn 19-il studju ta' Fażi 1, il-medja ta' t1/2 ta' perampanel kienet ta' 105 sigħat.
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.
Maltese: Fi studju fuq voluntiera b'saħħithom biex jiġu evalwati l-effetti ta' perampanel fuq l-attenzjoni, u lmemorja bl-użu ta' serje standard ta' evalwazzjonijiet, ma nstabu l-ebda effetti ta' perampanel wara dożi waħidhom u multipli ta' perampanel sa 12 mg/kuljum.
English: Levetiracetam No influence
Maltese: Twissijiet u prekawzjonijiet
English: The number of perampanel subjects taking enzyme-inducing anti-epileptic medicinal products was small (n = 9).
Maltese: In-numru ta' individwi fuq perampanel li kienu qed jieħdu prodotti mediċinali antiepilettiċi li jinduċu l-enzimi kien żgħir (n = 9).
English: Purple, round, biconvex tablet, engraved with E295 on one side and ‘8' on other side
Maltese: Pillola vjola, tonda, bikonvessa, imnaqqxa b'E295 fuq naħa waħda u ‘8' fuq in-naħa l-oħra
English: Response rates after addition of perampanel at fixed doses were less when patients received concomitant CYP3A enzyme-inducing anti-epileptic medicinal products (carbamazepine, phenytoin, oxcarbazepine) as compared to response rates in patient who received concomitant non-enzyme-inducing anti-epileptic medicinal products.
Maltese: Ir-rati ta' rispons wara ż-żieda ta' perampanel f'dożi fissi kienu inqas meta pazjenti rċivew fl-istess ħin prodotti mediċinali antiepilettiċi li jinduċu CYP3A (carbamazepine, phenytoin, oxcarbazepine) meta mqabbla mar-rati ta' rispons f'pazjent li rċieva fl-istess ħin prodotti mediċinali antiepilettiċi li ma jinduċux l-enzimi.
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).
Maltese: F'dożi ta' 12 mg/kuljum Fycompa jista' jnaqqas l-effettività ta' kontraċettivi ormonali li fihom progestative; f'din iċ-ċirkustanza forom oħrajn ta' kontraċettivi mhux ormonali addizzjonali huma rakkomandati meta jintuża Fycompa (ara sezzjoni 4.5).
English: Conversely, withdrawal of a concomitant CYP450 3A enzyme inducer can be expected to increase plasma concentrations of perampanel and dose reduction may be required.
Maltese: Bil-kontra, it-twaqqif ta' induttur tal-enzimi CYP450 3A fl-istess ħin jista' jiġi mistenni li jżid il-konċentrazzjonijiet ta' perampanel fil-plażma u tnaqqis fid-doża jista' jkun meħtieġ.
English: Red, round, biconvex tablet, engraved with E277 on one side and ‘4' on other side
Maltese: Pillola ħamra, tonda, bikonvessa, imnaqqxa b'E277 fuq naħa waħda u ‘4' fuq in-naħa l-oħra
English: Ethinylestradiol AUC was not affected by Fycompa 12 mg whereas Cmax was decreased by 18%.
Maltese: L-AUC ta' ethinylestradiol ma ġiex affettwat minn Fycompa 12 mg filwaqt li s-Cmax tnaqqas bi 18%.
English: In urine and faeces, recovered radioactivity was primarily composed of a mixture of oxidative and conjugated metabolites.
Maltese: Fl-awrina u fl-ippurgar, irradjuattività rkuprata kienet primarjament komposta minn taħlita ta' metaboliti ossidattivi u konjugati.
English: 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.
Maltese: Analiżi ta' informazzjoni dwar is-sigurtà f'905 persuna anzjana li kienu kkurati b'perampanel (fi studji double-blind li saru f'indikazzjonijiet mhux ta' epilessija) ma żvelaw l-ebda differenzi relatati mal-età fil-profil tas-sigurtà.
English: In all controlled and uncontrolled trials in patients with partial-onset seizures, 1,639 subjects have received perampanel of whom 1,147 have been treated for 6 months and 703 for longer than 12 months.
Maltese: Fl-istudji kollha kkontrollati u mhux ikkontrollati f'pazjenti b'aċċessjonijiet li jibdew parzjalment, 1,639 persuna rċivew perampanel li minnhom 1,147 ġew ikkurati għal 6 xhur u 703 għal aktar minn 12-il xahar.
English: The precise mechanism by which perampanel exerts its antiepileptic effects in humans remains to be fully elucidated.
Maltese: M'hemm l-ebda antidot speċifiku disponibbli għall-effetti ta' perampanel.
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.
Maltese: Flixkun tal-polyethylene terephthalate (PET) b'għatu tal-polypropylene (PP) li ma jinfetaħx mit-tfal (child-resistant (CR)); kull flixkun fih 340 ml ta' suspensjoni f'kaxxa ta' barra tal-kartun.
English: - Some other medicines such as rifampicin (a medicine used to treat bacterial infections),
Maltese: - Xi mediċini oħrajn bħal rifampicin (mediċina li tintuża għall-kura ta' infezzjonijiet batterjali),
English: Perampanel should be used with caution in elderly taking into account the drug interaction potential in polymedicated patients (see section 4.4).
Maltese: Perampanel għandu jintuża b'kawtela minn persuni anzjani u wieħed għandu jikkunsidra lpotenzjal ta' interazzjoni tal-mediċina f'pazjenti polimedikati (ara sezzjoni 4.4).
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.
Maltese: Fil-prova klinika kkontrollata ta' Fażi 3 dwar aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji, irrata ta' twaqqif b'riżultat ta' reazzjoni avversa kienet ta' 4.9% f'pazjenti li ntgħażlu b'mod każwali biex jirċievu perampanel 8 mg, u 1.2% f'pazjenti li ntgħażlu b'mod każwali biex jirċievu plaċebo.
English: Confusional state
Maltese: Ansjetà Stat ta' konfużjoni
English: Concomitant CYP 3A inducing anti-epileptic medicinal products
Maltese: L-użu fl-istess ħin ta' prodotti mediċinali antiepilettiċi li jinduċu CYP3A
English: The metabolism of perampanel is mediated primarily by CYP3A based on clinical study results in healthy subjects administered radiolabeled perampanel and supported by in vitro studies using recombinant human CYPs and human liver microsomes.
Maltese: Il-metaboliżmu ta' perampanel hu medjat primarjament minn CYP3A ibbażat fuq riżultati ta' studju kliniku f'individwi b'saħħithom li ngħataw perampanel radjutikkettat u appoġġjat minn studji in vitro li użaw CYPs rikombinanti umani u mikrożomi tal-fwied tal-bniedem.
English: The adverse reaction most commonly leading to discontinuation (≥ 2% in the perampanel group and greater than placebo) was dizziness.
Maltese: Irreazzjoni avversa li l-aktar li twassal b'mod komuni għat-twaqqif (≥2 % fil-grupp ta' perampanel u akbar mill-plaċebo) kien l-isturdament.
English: Fycompa 8 mg film-coated tablets 8 mg - packs of 7, 28, 84 and 98
Maltese: Fycompa 8 mg pilloli miksija b'rita 8 mg - pakketti ta' 7, 28, 84 u 98
English: During the 3 months maintenance period, 30.9% (25/81) of the patients on perampanel in the clinical studies became free of PGTC seizures compared with 12.3% (10/81) on placebo.
Maltese: Matul il-perjodu ta' manteniment ta' 3 xhur, 30.9% (25/81) tal-pazjenti li kienu qed jieħdu perampanel fl-istudji kliniċi, ma kellhom l-ebda aċċessjonijiet PGTC meta mqabbla ma' 12.3% (10/81) tal-pazjenti li kienu qed jieħdu plaċebo.
English: How to store Fycompa
Maltese: X'fih Fycompa
English: In the open label extension, no significant changes were observed in global CDR system score after 52 weeks of perampanel treatment (see section 5.1 Paediatric population).
Maltese: Fl-estensjoni open-label, l-ebda bidliet sinifikanti ma ġew osservati fil-punteġġ tas-sistema CDR globali wara 52 ġimgħa ta' kura b'perampanel (ara sezzjoni 5.1 Popolazzjoni pedjatrika).
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).
Maltese: Skont ir-rispons kliniku u t-tollerabilità individwali f'doża ta' 8 mg/jum (16 ml/jum), id-doża tista' tiżdied sa 12 mg/jum (24 ml/jum), li tista' tkun effettiva f'xi pazjenti (ara sezzjoni 4.4).
English: In the Extension Phase, 73.7% of subjects have a modal daily perampanel dose of greater than 4 to 8 mg/day and 16.7% had a modal daily dose of greater than 8 to 12 mg/day.
Maltese: Fil-Fażi ta' Estensjoni, 73.7% tal-individwi kellhom doża modali ta' perampanel kuljum ta' aktar minn 4 sa 8 mg/jum, u 16.7% kellhom doża modali ta' kuljum ta' aktar minn 8 sa 12 mg/jum.
English: Thirty four (34) patients were followed up for at least 6 months and, of these, 24 patients (71%) remained on perampanel monotherapy for at least 6 months.
Maltese: Erba' u tletin (34) pazjent ġew segwiti għal mill-inqas 6 xhur u, minn dawn, 24 pazjent (71%) baqgħu fuq monoterapija b'perampanel għal mill-inqas 6 xhur.
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).
Maltese: Skont ir-rispons kliniku individwali u ttollerabilità għal doża ta' 8 mg kuljum (16 ml/jum), id-doża tista' tiżdied b'inkrementi ta' 2 mg/kuljum (4 ml/jum) għal 12 mg/kuljum (24 ml/jum).
English: Perampanel is eliminated almost exclusively by metabolism followed by rapid excretion of metabolites; only trace amounts of perampanel metabolites are observed in plasma.
Maltese: Perampanel jiġi eliminat kważi esklussivament permezz tal-metaboliżmu, segwit minn tneħħija mgħaġġla tal-metaboliti; ammonti żgħar ħafna tal-metaboliti ta' perampanel jiġu osservati fil-plażma.
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.
Maltese: Riżultat simili ġie osservat f'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti b'aċċessjonijiet li jibdew parzjalment li kienu qed jirċievu perampanel sa 12 mg/kuljum u pazjenti b'aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji li kienu qed jirċievu perampanel sa 8 mg/jum fi provi kliniċi kkontrollati bi plaċebo.
English: Of these, 14 patients (27%) reverted to adjunctive therapy in the following months.
Maltese: Minn dawn, 14-il pazjent (27%) reġgħu lura għal terapija aġġuntiva fix-xhur ta' wara.
English: Fycompa 10 mg tablets Perampanel
Maltese: Fycompa 10 mg pilloli Perampanel
English: Switching between the tablet and suspension formulation should be done with caution (see section 5.2).
Maltese: Li taqleb bejn il-formulazzjoni tal-pillola u s-suspensjoni għandu jsir b'kawtela (ara sezzjoni 5.2).
English: Fycompa 4 mg tablets Perampanel
Maltese: Fycompa 4 mg pilloli Perampanel
English: Fycompa 12 mg tablets Perampanel
Maltese: Fycompa 12 mg pilloli Perampanel
English: Green, round, biconvex tablet, engraved with E296 on one side and ‘10' on other side
Maltese: Pillola ħadra, tonda, bikonvessa, imnaqqxa b'E296 fuq naħa waħda u ‘10' fuq in-naħa l-oħra
English: Fycompa is not considered a strong inducer or inhibitor of cytochrome P450 or UGT enzymes (see section 5.2).
Maltese: Fycompa mhuwiex ikkunsidrat li hu induttur jew inibitur qawwi ta' ċitokrom P450 jew enzimi UGT (ara sezzjoni 5.2).
English: Fycompa 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg film-coated tablets Perampanel
Maltese: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg u 12 mg pilloli miksija b'rita Perampanel
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal products in several indications.
Maltese: Ħsibijiet u mġiba marbuta ma' suwiċidji, ġew irrappurtati f'pazjenti kkurati bi prodotti mediċinali antiepilettiċi f'diversi indikazzjonijiet.
English: Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal overexcitation.
Maltese: Glutamate hu n-newrotrasmettitur eċċitatorju primarju fis-sistema nervuża ċentrali u hu implikat f'numru ta' disturbi newroloġiċi kkawżati minn eċċitazzjoni eċċessiva newronali.
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).
Maltese: Reazzjonijiet avversi severi tal-ġilda (SCARs, severe cutaneous adverse reactions) li jinkludu reazzjoni tal-mediċina b'eosinofilija u sintomi sistemiċi (DRESS, drug reaction with eosinophilia and systemic symptoms), ġew irrappurtati f'assoċjazzjoni mal-kura bi perampanel (ara sezzjoni 4.4).
English: Compared with positive controls (including phenobarbital, rifampicin), perampanel was found to weakly induce CYP2B6 (30 µmol/l) and CYP3A4/5 (≥ 3 µmol/l) among major hepatic CYPs and UGTs in cultured human hepatocytes.
Maltese: Induzzjoni ta' enzimi li jimmetabolizzaw il-mediċina Meta mqabbel mal-kontrolli pożittivi (li jinkludu phenobarbital, rifampicin), instab li perampanel jinduċi b'mod dgħajjef CYP2B6 (30 µmol/l) u CYP3A4/5
English: In the controlled and uncontrolled trial in patients with primary generalised tonic-clonic seizures, 114 subjects have received perampanel of whom 68 have been treated for 6 months and 36 for longer than 12 months.
Maltese: Fil-prova kkontrollata u mhux ikkontrollata f'pazjenti b'aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji, 114-il individwu rċivew perampanel, li minnhom 68 ġew ikkurati għal 6 xhur u 36 għal aktar minn 12-il xahar.
English: Clonazepam No influence
Maltese: L-ebda influwenza
English: Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.
Maltese: Fycompa huwa indikat għal kura aġġuntiva ta' aċċessjonijiet li jibdew parzjalment bi jew mingħajr aċċessjonijiet ġeneralizzati sekondarji f'pazjenti adulti u adolexxenti li jkollhom 12-il sena jew aktar b'epilessija.
English: Fycompa 6 mg tablets Perampanel
Maltese: Fycompa 6 mg pilloli Perampanel
English: Common (may affect more than 1 user in 100) are: - increased or decreased appetite, weight gain - feeling aggressive, angry, irritable, anxious or confused - difficulty with walking or other balance problems (ataxia, gait disturbance, balance disorder) - slow speech (dysarthria) - blurred vision or double vision (diplopia) - spinning sensation (vertigo) - feeling sick (nausea) - back pain - feeling very tired (fatigue) - falling down
Maltese: Komuni (jistgħu jaffettwaw iktar minn utent 1 minn kull 100) huma: - żieda jew tnaqqis fl-aptit, żieda fil-piż - tħossok aggressiv, irrabjat, irritabbli, ansjuż jew konfuż - diffikultà biex timxi jew problemi oħrajn fil-bilanċ (nuqqas ta' bilanċ, disturb fil-mod kif timxi,
English: Fycompa 4 mg film-coated tablets 4 mg - packs of 7, 28, 84 and 98
Maltese: Fycompa 4 mg pilloli miksija b'rita 4 mg - pakketti ta' 7, 28, 84 u 98
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.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti b'aċċessjonijiet li jibdew b'mod parzjali li kienu qed jirċievu perampanel sa 12 mg/jum u pazjenti b'aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji li kienu qed jirċievu perampanel sa 8 mg/jum mg/kuljum fi provi kliniċi kkontrollati bi plaċebo, instabet relazzjoni lineari bejn id-doża u l-konċentrazzjonijiet ta' perampanel fil-plażma.
English: In a placebo controlled study conducted in adolescent patients, no significant changes in cognition relative to placebo as measured by Cognitive Drug Research (CDR) System Global Cognition Score were observed for perampanel.
Maltese: Fi studju kkontrollat bi plaċebo li twettaq f'pazjenti adolexxenti, ma ġew osservati l-ebda bidliet sinifikanti fil-konjizzjoni meta mqabbla mal-plaċebo kif imkejla mill-Cognitive Drug Research (CDR) System Global Cognition Score għal perampanel.
English: Fycompa 6 mg film-coated tablets 6 mg - packs of 7, 28, 84 and 98
Maltese: Fycompa 6 mg pilloli miksija b'rita 6 mg - pakketti ta' 7, 28, 84 u 98
English: In in vitro studies, perampanel did not compete with AMPA for binding to the AMPA receptor, but perampanel binding was displaced by noncompetitive AMPA receptor antagonists, indicating that perampanel is a noncompetitive AMPA receptor antagonist.
Maltese: Fi studji in vitro, perampanel ma kkompetiex ma' AMPA għat-twaħħil mar-riċettur AMPA, iżda t-twaħħil ta' perampanel ġie spostat minn antagonisti mhux kompetittivi ta' riċettur AMPA, u dan jindika li perampanel hu antagonist mhux kompetittiv ta' riċettur AMPA.
English: 7 film-coated tablets 28 film-coated tablets 98 film-coated tablets
Maltese: 7 pilloli miksija b'rita 28 pilloli miksija b'rita 98 pilloli miksija b'rita
English: Oral suspension White to off-white suspension
Maltese: Suspensjoni orali Suspensjoni ta' lewn abjad sa abjad jagħti fil-griż
English: No efficacy benefit was observed at the dose of 12 mg as compared to the dose of 8 mg in the overall population.
Maltese: Ma ġie osservat l-ebda benefiċċju ta' effikaċja fid-doża ta' 12 mg meta mqabbel mad-doża ta' 8 mg fil-popolazzjoni globali.
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).
Maltese: Aċċessjonijiet Toniċi-Kloniċi Ġeneralizzati Primarji Perampanel bħala terapija aġġuntiva f'pazjenti li jkollhom 12-il sena u aktar, b'epilessija ġeneralizzata idjopatika, u li kellhom aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji, ġiet stabbilita fi studju kkontrollat bi plaċebo, multiċentriku, li fih il-parteċipanti ntgħażlu b'mod każwali u doubleblind (Studju 332).
English: 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.
Maltese: Jekk pazjent ikun waqqaf perampanel għal perjodu kontinwu ta' iktar minn 5 half-lives, hu rakkomandat li r-rakkomandazzjoni tad-dożaġġ inizjali mogħtija hawn fuq jiġu segwiti.
English: Open date:
Maltese: Preparazzjoni:
English: The 50% primary generalised tonic-clonic seizures responder rate during the Maintenance Period was significantly higher in the perampanel group (58.0%) than in the placebo group (35.8%), P = 0.0059.
Maltese: Ir-rata' ta' 50% ta' ta' dawk li rrispondew b'aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji matul il-Perjodu ta' Manteniment kienet sinifikament ogħla fil-grupp ta' perampanel (58.0%) milli fil-grupp tal-plaċebo (35.
English: Fycompa 10 mg film-coated tablets 10 mg - packs of 7, 28, 84 and 98
Maltese: Fycompa 10 mg pilloli miksija b'rita 10 mg - pakketti ta' 7, 28, 84 u 98
English: In a retrospective study of clinical practice, 51 patients with epilepsy who received perampanel as adjunctive treatment converted to perampanel monotherapy.
Maltese: Fi studju retrospettiv ta' prattika klinika, 51 pazjent b'epilessija li rċivew perampanel bħala kura aġġuntiva, qalbu għal monoterapija b'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.
Maltese: F'pazjenti b'aċċessjonijiet ta' assenza fl-istess ħin, il-ħelsien mill-aċċessjonijiet intlaħaq fi 22.2% (6/27) tal-pazjenti li kienu qed jieħdu perampanel meta mqabbel ma' 12.1% (4/33) ta' dawk li kienu fuq plaċebo.
English: Ferric oxide, red (E172) Ferric oxide, black (E172)
Maltese: Titanium dioxide (E171) Ferric oxide, red (E172) Ferric oxide, black (E172)
English: You should use other forms of safe and effective contraception (such as a condom or coil) when taking Fycompa.
Maltese: Għandek tuża forom oħrajn ta' kontraċezzjoni sigura u effettiva (bħal kondom jew coil) meta tkun qed tieħu Fycompa.
English: In perampanel-treated patients in clinical trials, aggression, anger and irritability were reported more frequently at higher doses.
Maltese: Fi studji kliniċi f'pazjenti li jirċievu terapija b'perampanel, aggressjoni, rabja u irritabilità ġew irrappurtati b'mod iktar frekwenti f'dożi ogħla.
English: Each film-coated tablet contains 8 mg perampanel.
Maltese: Kull pillola fiha 8 mg ta' perampanel.
English: It belongs to a group of medicines called anti epileptics.
Maltese: Jappartjeni għal grupp ta' mediċini msejħa antiepilettiċi.