FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are sorbitol (E420) liquid (crystallising), microcrystalline cellulose (E460), carmellose sodium (E466), poloxamer 188, simethicone emulsion 30% (containing purified water, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid and sulfuric acid), citric acid, anhydrous (E330), sodium benzoate (E211) and purified water.
Maltese: - Is-sustanzi mhux attivi l-oħra huma sorbitol (E420) liquid (crystallising), microcrystalline cellulose (E460), carmellose sodium (E466), poloxamer 188, simethicone emulsion 30% (li fiha ilma ppurifikat, silicone oil, polysorbate 65, methylcellulose, silica gel, macrogol stearate, sorbic acid, benzoic acid u sulfuric acid), citric acid, anhydrous (E330), sodium benzoate (E211) u ilma ppurifikat.
English: Fycompa is available in packs of:
Maltese: Fycompa hu disponibbli f'pakketti ta':
English: It comes in a bottle of 340 ml with 2 graduated oral syringes and an LDPE press-in bottle adapter (PIBA).
Maltese: Jiġi fi flixkun ta' 340 ml b'żewġ siringi orali gradwati u identiċi u LDPE press-in bottle adapter (PIBA).
English: In vitro, perampanel inhibited AMPA-induced (but not NMDA-induced) increase in intracellular calcium.
Maltese: In vitro, perampanel inibixxa żieda indotta minn AMPA (iżda mhux indotta minn NMDA fil-calcium intraċellulari).
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
Maltese: 2 mg pilloli miksija b'rita Fycompa 4 mg pilloli miksija b'rita Fycompa 6 mg pilloli miksija b'rita Fycompa 8 mg pilloli miksija b'rita Fycompa 10 mg pilloli miksija b'rita Fycompa 12 mg pilloli miksija b'rita
English: Blister Pack (PVC/Aluminium blister)
Maltese: Pakkett bil-Folji (PVC/Folja tal-aluminju)
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX22
Maltese: Kategorija farmakoterapewtika: antiepilettiċi, antiepilettiċi oħrajn, Kodiċi ATC:
English: The total clearance of Fycompa was increased when administered with carbamazepine (2.75-fold), phenytoin (1.7-fold) and oxcarbazepine (1.9-fold), which are known inducers of enzymes of metabolism (see section 5.2).
Maltese: It-tneħħija totali ta' Fycompa żdiedet meta ngħata ma' carbamazepine (2.75 darbiet), phenytoin (1.7 darbiet) u oxcarbazepine (1.9 darbiet), li huma indutturi magħrufa ta' enzimi tal-metaboliżmu (ara sezzjoni 5.2).
English: Adverse reactions leading to discontinuation:
Maltese: Reazzjonijiet avversi li jwasslu għat-twaqqif:
English: Fycompa with alcohol
Maltese: Fycompa ma' alkoħol
English: Shake for at least 5 seconds before use.
Maltese: Ċaqlaq bis-saħħa għal mill-inqas 5 sekondi qabel l-użu.
English: Single and multiple doses of 8 mg and 12 mg impaired psychomotor performance in healthy volunteers in a dose-related manner.
Maltese: Dożi waħidhom u multipli ta' 8 mg u 12 mg ikkaġunaw indeboliment psikomotoreju f'voluntieri b'saħħithom b'mod relatat mad-doża.
English: In healthy subjects, the CYP3A4 inhibitor ketoconazole (400 mg once daily for 10 days) increased perampanel AUC by 20% and prolonged perampanel half--life by 15% (67.8 h vs 58.4 h).
Maltese: F'persuni b'saħħithom, l-inibitur ta' CYP3A4 ketoconazole (400 mg darba kuljum għal 10 ijiem) żied l-AUC ta' perampanel b'20% u tawwal il-half-life ta' perampanel bi 15% (67.8 sigħat vs 58.4 sigħat).
English: In a population pharmacokinetic analysis of patients with partial-onset seizures receiving Fycompa up to 12 mg/day in placebo-controlled clinical trials, Fycompa did not affect to a clinically relevant manner the clearance of clonazepam, levetiracetam, phenobarbital, phenytoin, topiramate, zonisamide, carbamazepine, clobazam, lamotrigine and valproic acid, at the highest perampanel dose evaluated (12 mg/day).
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti b'aċċessjonijiet li jibdew parzjalment li kienu qed jirċievu Fycompa sa 12 mg/kuljum fi provi kliniċi kkontrollati bi plaċebo, Fycompa m'affettwax b'mod rilevanti kliniku it-tneħħija ta' clonazepam, levetiracetam, phenobarbital, phenytoin, topiramate, zonisamide, carbamazepine, clobazam, lamotrigine u valproic acid, fl-ogħla doża ta' perampanel li ġiet evalwata (12 mg/kuljum).
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.
Maltese: Perampanel hu antagonist selettiv first-in-class, antagonist mhux kompetittiv tar-riċettur ionotropic αamino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) glutamate fuq newroni postsinattiċi.
English: Psychiatric disorders
Maltese: Prestazzjoni psikomotoreja
English: Interactions between Fycompa and other anti-epileptic medicinal products
Maltese: Interazzjonijiet bejn Fycompa u prodotti mediċinali antiepilettiċi oħrajn
English: PVC/aluminium blisters
Maltese: Folji tal-PVC/aluminju
English: The placental transfer was relatively low; 0.09% or less of administered dose was detected in the foetus.
Maltese: It-trasferiment mill-plaċenta kien relattivament baxx; 0.09% jew inqas tad-doża mogħtija ġiet osservata fil-fetu.
English: Tablet core (2 mg and 4 mg tablets):
Maltese: Qalba tal-pillola (pilloli ta' 2 mg u 4 mg):
English: 8 mg tablet: Ferric Oxide, Red (E172), Ferric Oxide, Black (E172) 10 mg tablet: Ferric Oxide, Yellow (E172), FD&C Blue #2 Indigo carmine aluminium lake (E132) 12 mg tablet: FD&C Blue #2 Indigo carmine aluminium lake (E132)
Maltese: Pillola ta' 8 mg: Ferric Oxide, Red (E172), Ferric Oxide, Black (E172) Pillola ta' 10 mg: Ferric Oxide, Yellow (E172), FD&C Blue #2 Indigo carmine aluminium lake (E132)
English: Fycompa contains lactose (a type of sugar).
Maltese: Fycompa fih il-lactose (tip ta' zokkor).
English: Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy (see section 5.1).
Maltese: Fycompa huwa indikat għal kura aġġuntiva ta' aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji f'pazjenti adulti u adolexxenti li jkollhom minn 12-il sena ‘l fuq b'epilessija ġeneralizzata idjopatika (ara sezzjoni 5.1).
English: Excipient with known effect: Each 2 mg tablet contains 78.5 mg of lactose (as monohydrate).
Maltese: Kull pillola ta' 2 mg fiha 78.5 mg ta' lactose (bħala monohydrate).
English: 4 mg, 6 mg, 8 mg, 10 mg, 12 mg tablets - packs of 7, 28, 84 and 98
Maltese: Pilloli ta' 4 mg, 6 mg, 8 mg, 10 mg, 12 mg - pakketti ta' 7, 28, 84 u 98
English: In the epilepsy population pharmacokinetic analysis, perampanel was found to decrease the clearance of oxcarbazepine by 26%.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni bl-epilessija, instab li perampanel naqqas it-tneħħija ta' oxcarbazepine b'26%.
English: The 50% responder rate was 22.2% in combination with enzyme-inducing anti-epileptic medicinal products and was 69.4% when perampanel was given in combination with non-enzyme-inducing anti-epileptic medicinal products.
Maltese: Ir-rata ta' 50% ta' dawk li rrispondew kienet ta' 22.2% flimkien ma' prodotti mediċinali antiepilettiċi li jinduċu l-enzimi, u kienet ta' 69.4% meta perampanel ingħata flimkien ma' prodotti mediċinali antiepilettiċi li ma jinduċux l-enzimi.
English: Cartons of 7, 28,84 and 98 tablets
Maltese: Kartun ta' 7, 28, 84 u 98 pillola
English: Other medicines and Fycompa
Maltese: Mediċini oħra u Fycompa
English: Each carton contains one bottle, two 20 mL graduated oral dosing syringes and an LDPE press-in bottle adapter (PIBA).
Maltese: Kull kaxxa tal-kartun fiha flixkun wieħed, żewġ siringi orali tad-dożaġġ gradwati ta' 20 mL, u LDPE press-in bottle adapter (PIBA).
English: The pharmacokinetics of perampanel have been studied in healthy adult subjects (age range 18 to 79), adults and adolescents with partial-onset seizures and primary generalised tonic-clonic seizures, adults with Parkinson's disease, adults with diabetic neuropathy, adults with multiple sclerosis, and subjects with hepatic impairment.
Maltese: Il-farmakokinetika ta' perampanel ġiet studjata f'persuni adulti b'saħħithom (medda ta' età minn 18 sa 79), adulti u adolexxenti b'aċċessjonijiet li jibdew parzjalment u aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji, adulti bil-marda ta' Parkinson, adulti b'newropatija dijabetika, adulti bi sklerożi multipla, u persuni b'indeboliment tal-fwied.
English: Perampanel at doses of 4 mg/day to 12 mg/day has been shown to be effective therapy in partial-onset seizures.
Maltese: Intwera li perampanel f'dożi ta' 4 mg/kuljum sa 12 mg/kuljum hu terapija effettiva għal aċċessjonijiet li jibdew parzjalment.
English: 6 mg tablet: Ferric Oxide, Red (E172)
Maltese: Pillola ta' 6 mg: Ferric Oxide, Red (E172)
English: Carbamazepine, a known potent enzyme inducer, reduced perampanel levels by two-thirds in a study performed on healthy subjects.
Maltese: Carbamazepine, induttur potenti magħruf tal-enzimi, naqqas il-livelli ta' perampanel b'żewġ terzi fi studju li twettaq fuq persuni b'saħħithom.
English: *The colourants are:
Maltese: *Il-koloranti huma:
English: The mean change (SD) from baseline to end of double-blind treatment (19 weeks) in CDR System Global Cognition t-Score was 1.1 (7.14) in the placebo group and (minus) -1.0 (8.86) in the perampanel group, with the difference between the treatment groups in LS means (95% CI) = (minus) -2.2 (-5.2, 0.8).
Maltese: Il-bidla medja (SD) mil-linja bażi sal-aħħar tal-kura double-blind (19-il Ġimgħa) fis-CDR System Global Cognition t-Score kienet ta' 1.1 (7.14) fil-grupp tal-plaċebo u (minus) -1.0 (8.86) fil-grupp ta' perampanel, bid-differenza bejn il-gruppi ta' kura fil-medji LS (95% CI) = (minus) -2.2 (-5.2, 0.8).
English: What Fycompa looks like and contents of the pack All strengths of Fycompa are round, biconvex film-coated tablets 2 mg: orange, marked with E275 on one side and 2 on other side 4 mg: red, marked with E277 on one side and 4 on other side 6 mg: pink, marked with E294 on one side and 6 on other side 8 mg: purple, marked with E295 on one side and 8 on other side 10 mg: green, marked with E296 on one side and 10 on other side 12 mg: blue, marked with E297 on one side and 12 on other side
Maltese: Il-qawwiet kollha ta' Fycompa huma pilloli miksija b'rita u tondi 2 mg: oranġjo, immarkata b'E275 fuq naħa waħda u ‘2' fuq in-naħa l-oħra 4 mg: ħamra, immarkata b'E277 fuq naħa waħda u ‘4' fuq in-naħa l-oħra 6 mg: roża, immarkata b'E294 fuq naħa waħda u ‘6' fuq in-naħa l-oħra 8 mg: vjola, immarkata b'E295 fuq naħa waħda u ‘8' fuq in-naħa l-oħra 10 mg: ħadra, immarkata b'E296 fuq naħa waħda u ‘10' fuq in-naħa l-oħra 12 mg: blu, immarkata b'E297 fuq naħa waħda u ‘12' fuq in-naħa l-oħra
English: Dysarthria Balance disorder Irritability
Maltese: Disartrija Disturb fil-bilanċ Irritabilità
English: 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.
Maltese: Ilfunzjoni konoxxittiva ġiet evalwata mill-Cognitive Drug Research (CDR) System Global Cognition tScore, li hu punteġġ kompost derivat minn 5 dominji li jittestjaw il-Qawwa tal-Attenzjoni, ilKontinwità tal-Attenzjoni, il-Kwalità tal-Memorja Sekondarja Episodika, il-Kwalità tal-Memorja Operattiva u l-Veloċità tal-Memorja.
English: 1.9 fold decrease
Maltese: .9 Doża eċċessiva
English: Excipient with known effect: Each 10 mg tablet contains 147.0 mg of lactose (as monohydrate).
Maltese: Kull pillola ta' 10 mg fiha 147.0 mg ta' lactose (bħala monohydrate).
English: A statistically significant effect on the reduction in 28-day seizure frequency (Baseline to Treatment Phase) as compared to the placebo group was observed with perampanel treatment at doses of 4 mg/day (Study 306), 8 mg/day (Studies 304, 305 and 306), and 12 mg/day (Studies 304 and 305).
Maltese: Ġie osservat effett statistikament sinifikanti fuq it-tnaqqis fil-frekwenza ta' aċċessjonijiet matul 28 jum (Linja Bażi sal-Fażi ta' Kura) meta mqabbel mal-grupp tal-plaċebo, bil-kura b'perampanel f'dożi ta' 4 mg/kuljum (Studju 306), 8 mg/kuljum (Studji 304, 305 u 306), u 12 mg/kuljum (Studji 304 u 305).
English: For patients with perampanel in the open label extension (n = 112), the mean change (SD) from baseline to end of open-label treatment (52 weeks) in CDR System Global Cognition t-Score was (minus) -1.0 (9.91).
Maltese: Għal pazjenti b'perampanel fl-estensjoni openlabel (n=112), il-bidla medja (SD) mil-linja bażi sal-aħħar tal-kura open-label (52 Ġimgħa) fis-CDR System Global Cognition t-Score kienet ta' (minus) -1.0 (9.91).
English: Open label extension study
Maltese: Studju ta' estensjoni open-label
English: A decrease in PGTC seizure frequency of at least 50% was seen in 65.9% of subjects after 1 year of treatment during the Extension Phase (relative to their pre-perampanel baseline seizure frequency).
Maltese: Tnaqqis fil-frekwenza ta' aċċessjonijiet PGTC ta' mill-inqas 50% ġie osservat f'65.9% tal-individwi wara sena ta' kura matul ilFażi ta' Estensjoni (meta mqabbel mal-frekwenza tagħhom ta' aċċessjonijiet fil-linja qabel ma bdew jieħdu perampanel).
English: Carton of 7, 28 and 98 tablets
Maltese: Kartuna ta' 7, 28 u 98 pilloli
English: 1) Active metabolite monohydroxycarbazepine was not assessed.
Maltese: Il-metabolit attiv monohydroxycarbazepine ma ġiex evalwat.
English: Some anti-epileptic drugs known as CYP450 3A enzyme inducers (carbamazepine, phenytoin, oxcarbazepine) have been shown to increase perampanel clearance and consequently to decrease plasma concentrations of perampanel.
Maltese: Intwera li xi mediċini antiepilettiċi magħrufa bħal indutturi tal-enzimi CYP450 3A (carbamazepine, phenytoin, oxcarbazepine) iżidu t-tneħħija ta' perampanel u konsegwentement inaqqsu konċentrazzjonijiet fil-plażma ta' perampanel.
English: Potential interactions between Fycompa (up to 12 mg once daily) and other anti-epileptic drugs (AEDs) were assessed in clinical studies and evaluated in the population PK analysis of four pooled Phase 3 studies including patients with partial-onset seizures and primary generalised tonic-clonic seizures.
Maltese: Interazzjonijiet potenzjali bejn Fycompa (sa 12 mg darba kuljum) u mediċini antiepilettiċi oħrajn (AEDs) ġew evalwati fi studji kliniċi u evalwati fl-analiżi PK fil-popolazzjoni ta' erba' studji miġbura ta' Fażi 3 li jinkludu pazjenti b'aċċessjonijiet b'bidu parzjali u aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji.
English: Elderly (65 years of age and above)
Maltese: Anzjani (65 sena u aktar)
English: Fycompa 6 mg, 8 mg, 10 mg, 12 mg film-coated tablets
Maltese: Fycompa 6 mg, 8 mg, 10 mg, 12 mg pilloli miksija b'rita
English: Suicidal ideation Suicide attempt
Maltese: tipprova ttemm ħajtek (tentattiv ta' suwiċidju)
English: 2 mg tablet: Ferric Oxide, Yellow (E172), Ferric Oxide, Red (E172) 4 mg tablet: Ferric Oxide, Red (E172)
Maltese: Pillola ta' 2 mg: Ferric Oxide, Yellow (E172), Ferric Oxide, Red (E172) Pillola ta' 4 mg: Ferric Oxide, Red (E172)
English: Based on the clinical trial database of 196 adolescents exposed to perampanel from double-blind studies for partial-onset seizures and primary generalised tonic-clonic seizures, the overall safety profile in adolescents was similar to that of adults, except for aggression, which was observed more frequently in adolescents than in adults.
Maltese: Ibbażat fuq id-database tal-provi kliniċi ta' 196 persuna adolexxenti esposti għal perampanel minn studji double-blind għal aċċessjonijiet b'bidu parzjali u aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji, il-profil tas-sigurtà globali fl-adolexxenti kien simili għal dak tal-adulti, ħlief għallaggressjoni, li ġiet osservata aktar ta' spiss fl-adolexxenti milli fl-adulti.
English: - Felbamate (a medicine used to treat epilepsy) may also affect Fycompa.
Maltese: - Felbamate (mediċina li tintuża biex tikkura l-epilessija) jista' jaffettwa wkoll lil Fycompa.
English: Perampanel is extensively metabolised via primary oxidation and sequential glucuronidation.
Maltese: Perampanel jiġi metabolizzat b'mod estensiv permezz ta' ossidazzjoni primarja u glukuronidazzjoni sekwenzjali.
English: The three pivotal double-blind placebo-controlled phase 3 studies included 143 adolescents between the ages of 12 and 18.
Maltese: It-3 studji importanti ħafna ta' fażi 3, double-blind, ikkontrollati bi plaċebo, kienu jinkludu 143 persuni adolexxenti li kellhom bejn 12 u 18-il sena.
English: Fycompa 0.5 mg/ml oral suspension Perampanel
Maltese: Fycompa 0.5 mg/ml suspensjoni orali perampanel
English: Blue, round, biconvex tablet, engraved with E297 on one side and ‘12' on other side
Maltese: Pillola blu, tonda, bikonvessa, imnaqqxa b'E297 fuq naħa waħda u ‘12' fuq in-naħa l-oħra
English: In a population pharmacokinetic analysis of patients with partial-onset seizures (age range 12 to 74 years) and primary generalised tonic-clonic seizures (age range 12 to 58 years), and receiving perampanel up to 8 or 12 mg/day in placebo-controlled clinical trials, no significant effect of age on perampanel clearance was found.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti li kellhom bidu t'aċċessjonijiet parzjali (medda ta' età ta' 12 sa 74 sena) u aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji (medda ta' età ta' 12 sa 58 sena), u li kienu qed jirċievu sa 8 jew 12 mg/kuljum perampanel fi provi kliniċi kkontrollati bi plaċebo, ma nstab l-ebda effett sinifikanti tal-età fuq it-tneħħija ta' perampanel.
English: Orange, round, biconvex tablet, engraved with E275 on one side and ‘2' on other side
Maltese: Pillola oranġjo, tonda, bikonvessa, imnaqqxa b'E275 fuq naħa waħda u ‘2' fuq in-naħa l-oħra
English: hypericum (St. John's Wort) (a medicine used to treat mild anxiety) and ketoconazole (a medicine used to treat fungal infections) may affect Fycompa.
Maltese: hypericum (St. John's Wort) (mediċina li tintuża biex tikkura ansjetà ħafifa) u ketoconazole
English: Multiple dosing of perampanel 12 mg/day increased levels of anger, confusion, and depression as assessed using the Profile of Mood State 5-point rating scale (see section 5.1).
Maltese: Dożaġġ multiplu ta' perampanel 12 mg/kuljum żied il-livell ta' rabja, konfużjoni, u dipressjoni kif evalwat bl-użu tal-iskala ta' klassifikazzjoni ta' 5 punti tal-Profil tal-Istat tal-Burdata (ara sezzjoni 5.1).
English: Each millilitre contains 0.5 mg of perampanel.
Maltese: Kull millimetru fih 0.5 mg ta' perampanel.
English: Pink, round, biconvex tablet, engraved with E294 on one side and ‘6' on other side
Maltese: Pillola roża, tonda, bikonvessa, imnaqqxa b'E294 fuq naħa waħda u ‘6' fuq in-naħa l-oħra
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:
Maltese: Ma dehrux effetti mhux mixtieqa waqt studji kliniċi, iżda dehru f'annimali f'livelli ta' esponiment simili għal-livelli ta' esponiment kliniku u b'rilevanza possibbli għall-użu kliniku kif spjegat:
English: In the controlled Phase 3 partial-onset seizures clinical trials, the rate of discontinuation as a result of an adverse reaction was 1.7%, 4.2% and 13.7% in patients randomised to receive perampanel at the recommended doses of 4 mg, 8 mg and 12 mg/day, respectively, and 1.4% in patients randomised to receive placebo.
Maltese: Fil-provi kliniċi kkontrollati ta' Fażi 3 dwar aċċessjonijiet b'bidu parzjali, ir-rata ta' twaqqif bħal riżultat ta' reazzjoni avversa kienet ta' 1.7%, 4.2% u 13.7% f'pazjenti li ntgħażlu b'mod każwali biex jirċievu perampanel fid-dożi rakkomandati ta' 4 mg, 8 mg u 12 mg/kuljum, rispettivament, u 1.4% f'pazjenti li ntgħażlu b'mod każwali biex jirċievu plaċebo.
English: There is limited clinical experience with perampanel overdose in humans.
Maltese: Hemm esperjenza klinika limitata b'doża eċċessiva ta' perampanel fil-bnedmin.
English: Each bottle of 340 ml contains 170 mg perampanel
Maltese: Kull flixkun ta' 340 ml fih 170 mg ta' perampanel
English: - Midazolam (a medicine used to stop prolonged, acute (sudden) convulsive seizures, for sedation and sleep problem) may be affected by Fycompa.
Maltese: - Midazolam (mediċina li tintuża biex twaqqaf aċċessjonijiet twal, akuti (li jiġu f'daqqa) u konvulżivi, għal sedazzjoni u problemi fl-irqad) tista' tiġi affettwata minn Fycompa.
English: Freedom from all seizures was achieved in 23.5% (19/81) of patients on perampanel compared to 4.9% (4/81) of patients on placebo.
Maltese: Il-ħelsien millaċċessjonijiet kollha ntlaħaq fi 23.5% (19/81) tal-pazjenti li kienu qed jieħdu perampanel meta mqabbel ma' 4.9% (4/81) tal-pazjenti li kienu fuq plaċebo.
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).
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti li kellhom bidu t'aċċessjonijiet parzjali li kienu qed jirċievu sa 12 mg/kuljum perampanel u pazjenti b'aċċessjonijiet toniċi-kloniċi ġeneralizzati primarji li jkunu qed jirċievu perampanel sa 8 mg/jum fi provi kliniċi kkontrollati bi plaċebo, ittneħħija ta' perampanel fin-nisa (0.54 l/siegħa) kienet 18% inqas milli fl-irġiel (0.66 l/siegħa).
English: Symptoms of DRESS include typically, although not exclusively, fever, rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities and eosinophilia.
Maltese: Is-sintomi ta' DRESS tipikament jinkludu, għalkemm mhux b'mod esklussiv, deni, raxx assoċjat mal-involviment ta' sistemi oħrajn ta' organi, limfadenopatija, anormalitjiet fit-testijiet tal-funzjoni tal-fwied u eosinofilija.
English: Two studies (studies 304 and 305) compared doses of perampanel 8 and 12 mg/day with placebo and the third study (study 306) compared doses of perampanel 2, 4 and 8 mg/day with placebo.
Maltese: Żewġ studji (studji 304 u 305) qabblu dożi ta' perampanel 8 u 12 mg/kuljum ma' plaċebo u t-tielet studju (studju 306) qabbel doża ta' perampanel 2, 4 u 8 mg/kuljum ma' plaċebo.
English: 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).
Maltese: Il-konvenzjoni li ġejja ntużat għall-klassifikazzjoni tar-reazzjonijiet avversi: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli.
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.
Maltese: Studju double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo, li dam 19-il ġimgħa, b'fażi ta' estensjoni open-label (Studju 235), twettaq sabiex jiġu evalwati l-effetti fuq ilkonjizzjoni ta' Fycompa (medda tad-doża fil-mira ta' 8 sa 12 mg darba kuljum) bħala terapija aġġuntiva f'133 (Fycompa n=85, plaċebo n=48) pazjenti adolexxenti, li kellhom minn 12 sa inqas minn 18-il sena, li kellhom aċċessjonijiet b'bidu parzjali li ma kinux ikkontrollati b'mod adegwat.
English: Fycompa 8 mg tablets Perampanel
Maltese: Fycompa 8 mg pilloli Perampanel
English: In these three trials, subjects had a mean duration of epilepsy of approximately 21.06 years.
Maltese: F'dawn it-tliet provi, l-individwi kellhom tul medju ta' epilessija ta' madwar 21.06 snin.