FrancophonIA/ELRC3.0 huggingface dataset:
English: The number of patients with other ethnic background was limited.
Maltese: In-numru ta' pazjenti b' etniċita` oħra kien limitat.
English: 50 mg/5 ml
Maltese: INDIVIDWALI 50 mg/5 ml
English: The other ingredients are: sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), carmellose sodium, sucralose, sorbitol liquid, glycerol (E422), raspberry flavour, water, purified.
Maltese: L-eċċipjenti l-oħra huma: sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), carmellose sodium, sucralose, likwidu sorbitol, glycerol (E422), raspberry flavour, ilma, purifikat.
English: The steady-state plasma clearance of brivaracetam was similar (0.76 ml/min/kg) to young healthy male subjects (0.83 ml/min/kg) (see section 4.2).
Maltese: Il-eliminazzjoni steady state fil-plażma ta' brivaracetam kien simili (0.76 ml/min/kg) għal dik f' irġiel żagħżagħ f'saħħithom (0.83 ml/min/kg) (ara sezzjoni 4.2).
English: The most frequently reported adverse reactions (>10 %) with brivaracetam treatment were: somnolence (14.3 %) and dizziness (11.0 %).
Maltese: L-iżjed avvenimenti avversi frekwentament rraportati (>10%) b' trattament b' brivaracetam kienu: nagħas (14.3%) u sturdament (11.0%).
English: Allée de la Recherche 60 B-1070 Brussels Belgium
Maltese: B-1070 Brussels Belgium
English: Improvement in the median percent reduction in seizure frequency per 28 days has been observed in patients with type IC seizure (secondary generalized tonic-clonic seizures) at baseline treated with brivaracetam (66.6 % (n=62), 61.2 % (n=100) and 82.1 % (n=75) of the patients on brivaracetam 50 mg/day, 100 mg/day and 200 mg/day respectively as compared to placebo 33.3 % (n=115)).
Maltese: Emeljorament fil-medja tal-perċentaġġ ta' tnaqqis fil-frekwenza ta' aċċessjonijiet kull 28 ġurnata kienet osservata f'pazjenti b' aċċessjoni tat-tip IC (aċċessjonijiet tonic-clonic ġeneralizzati sekondarji) fil-linja bażi ttrattati b' brivaracetam (66.6 % (n=62), 61.2 % (n=100) u 82.1 % (n=75) tal-pazjenti fuq brivaracetam 50 mg/ġurnata, 100 mg/ ġurnata u 200 mg/ ġurnata rispettivament meta mqabbel malplaċebo 33.3 % (n=115)).
English: Currently available data are described in section 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 4.8, 5.1 u 5.2 imma l-ebda rakkomandazzjoni dwar ilpożoloġija ma tista' tingħata.
English: Diluents - Sodium chloride 9 mg/ml (0.9 %) solution for injection - Glucose 50 mg/ml (5 %) solution for injection - Lactated Ringer's solution for injection.
Maltese: Dilwenti - Sodium chloride 9 mg/ml (0.9 %) soluzzjoni għall-injezzjoni - Glucose 50 mg/ml (5 %) soluzzjoni għall-injezzjoni - Soluzzjoni għall-injezzjoni ta' Lactated Ringer.
English: • Packs of 14, 56 film-coated tablets and in multipacks containing 168 (3 packs of 56) filmcoated tablets in PVC/PCTFE - Aluminium blisters
Maltese: • Pakketti ta' 14, 56 pilloli miksija b'rita u f'pakketti multipli li fihom 168 (3 pakketti ta' 56) pilloli miksija b'rita f' folja tal-aluminju - PVC/PCTFE
English: Formal interaction studies have only been performed in adults.
Maltese: Studji formali ta' interazzjoni twettqu biss f'adulti.
English: Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase resulting in an increased concentration of carbamazepine epoxide, an active metabolite of carbamazepine.
Maltese: Brivaracetam huwa inhibitur moderat riversibli ta' epoxide hydrolase li jirriżulta f'żieda filkonċentrazzjoni ta' carbamazepine epoxide, metabolit attiv ta' carbamazepine.
English: 5 ml oral dosing syringe
Maltese: 5 mL siringa ta' dożaġġ orali
English: The percentages of patients with at least a 50 % reduction in seizure frequency were 20.3 %, 34.2 %, 39.5 %, and 37.8 % for placebo, 50 mg/day, 100 mg/day, and 200 mg/day, respectively.
Maltese: Ilperċentaġġi ta' pazjenti b' mill-inqas tnaqqis ta' 50 % fil-frekwenza ta' aċċessjonijiet kienu 20.3 %, 34.2 %, 39.5 %, u 37.8 % għall-plaċebo, 50 mg/ġurnata, 100 mg/ ġurnata, u 200 mg/ ġurnata, rispettivament.
English: Brivaracetam 200mg/day may increase plasma concentrations of medicinal products transported by OAT3.
Maltese: Brivaracetam 200mg/ġurnata jista` jżid il-konċentrazzjonijiet tal-plażma tal-prodotti mediċinali ttrasportati permezz ta' OAT3.
English: In safety pharmacology studies, the predominant effects were CNS related (mainly transient CNS depression and decreased spontaneous locomotor activity) seen at multiples (greater than 50 fold) of the pharmacologically active dose of brivaracetam, 2 mg/kg.
Maltese: F'studji farmakoloġiċi ta' sigurta`, l-effetti predominanti kienu relatati mas-CNS ( l-biċċa l-kbira depressjoni tas-CNS transitorja u attivita` lokomotorili spontanja mnaqqsa)li dehret f' multipli ( akbar minn 50 darba) tad-doża attiva farmakoloġoka ta' brivaracetam, 2 mg/kg.
English: In a study in elderly subjects (65 to79 years old; with creatinine clearance 53 to 98 ml/min/1.73 m²) receiving brivaracetam 400 mg/day in bid administration, the plasma half-life of brivaracetam was 7.9 hours and 9.3 hours in the 65 to 75 and >75 years groups, respectively.
Maltese: F'studju f' persuni anzjani (65 sa 79 sena t' eta`; b'creatinine clearence ta' 53 sa 98 ml/min/1.73 m²) li rċievew brivaracetam 400 mg/ġurnata b'teħid bid, il-half-life tal-plażma ta' brivaracetam kienet 7.9 siegħa u 9.3 siegħa fil-gruppi ta' bejn is- 65 u 75 sena u >75 sena, rispettivament.
English: Decreased appetite
Maltese: Nuqqas t'Aptit
English: Briviact contains sodium
Maltese: Briviact fih sodium
English: - Risk Management Plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: Briviact contains the active substance brivaracetam.
Maltese: Briviact fih is-sustanza attiva brivaracetam.
English: A pharmacokinetic study in subjects with hepatic cirrhosis (Child-Pugh grades A, B, and C) showed similar increases in exposure to brivaracetam irrespective of disease severity (50 %, 57 % and 59 %), relative to matched healthy controls.
Maltese: Studju tal-farmakokinetika f'persuni b' cirrhosis tal-fwied (gradi Child-Pugh A, B, u C) wrew żidiet fl-esponiment simili għal brivaracetam irrispettivament għas-severita` tal-marda (50 %, 57 % u 59 %), relativi għal kontrolli mqabblin f'saħħithom (ara sezzjoni 4.2)
English: CYP2B6 induction has not been investigated in vivo and brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz).
Maltese: L-induzzjoni ta' CYP2B6 ma kienitx investigata in vivo u brivaracetam jista` jnaqqas il-konċentrazzjonijiet tal-plażma tal-prodotti mediċinali immetabolizzati b' CYP2B6 (eż. efavirenz).
English: None a
Maltese: Xejn a
English: In clinical studies 2.5 % (4/161), 5.1 % (17/332) and 4.0% (10/249) of the patients on brivaracetam 50 mg/day, 100 mg/day and 200 mg/day respectively became seizure free during the 12-week treatment period compared with 0.5 % (2/418) on placebo.
Maltese: F'studji kliniċi 2.5 % (4/161), 5.1 % (17/332) u 4.0% (10/249) tal-pazjenti fuq brivaracetam 50 mg/ ġurnata, 100 mg/ ġurnata u 200 mg/ ġurnata rispettivament saru ħielsa minn aċċessjonijiet waqt il-perjodu tattrattament ta' 12-il ġimgħa meta mqabbel ma' 0.5 % (2/418) fuq plaċebo.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX23
Maltese: Kategorija farmakoterapewtika: mediċini ta' kontra l-epilessija, mediċini oħra ta' kontra l-epilessija, Kodiċi ATC:
English: 1 mg/kg/day (or 2 mg/kg/day)*
Maltese: 1 mg/kg/jum (jew 2 mg/kg/jum)*
English: Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A), a transmembrane glycoprotein found at presynaptic level in neurons and in endocrine cells.
Maltese: Brivaracetam juri affinita` għolja u selettiva għal synaptic vesicle protein 2A (SV2A), transmembrane glycoprotein li jinstgħab fill-livell ta' presynaptic f'neurons u f' celloli endrokriniċi.
English: When tested in vitro brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6.
Maltese: Meta ġie ttestjat in vitro, brivaracetam ma indottax CYP1A1/2 imma ndotta CYP3A4 u CYP2B6 .
English: 10 ml oral dosing syringe
Maltese: 10 mL siringa ta' dożaġġ orali
English: - If you drink alcohol while taking Briviact the negative effects of alcohol may be increased.
Maltese: - Jekk tixrob l-alkoħol waqt li tieħu Briviact l-effetti negattivi tal-alkoħil jistgħu jiżdiedu.
English: Common: may affect up to 1 in 10 people - restlessness and hyperactivity (psychomotor hyperactivity)
Maltese: Komuni: jistgħu jaffettwaw sa 1 minn kull 10 persuni - nuqqas ta' kwiet/sabar u iperattività (iperattività psikomotorja)
English: Brivaracetam has not been studied in patients undergoing hemodialysis (see section 4.2).
Maltese: Brivaracetam ma ġiex studjat f'pazjenti sottomessi għal emodijaliżi (ara sezzjoni 4.2).
English: Table 1: Pharmacokinetic interactions between brivaracetam and other AEDs AED coadministered Influence of AED on brivaracetam plasma concentration
Maltese: Tabella 1: Interazzjonijiet farmakokinetika bejn brivaracetam u AEDs AED meta jingħata flimkien
English: Neutropenia has been reported in 0.5 % (6/1099) brivaracetam patients and 0 % (0/459) placebo patients.
Maltese: Nutropinja ġiet irrapurtata f' 0.5% (6/1099) tal-pazjenti fuq brivaracetam u 0% (0/459) tal-pazjenti fuq plaċebo.
English: The recommended maintenance dose is 2 mg/kg/day.
Maltese: Id-doża ta' manteniment rakkomandata hi ta' 2 mg/kg/jum.
English: Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.
Maltese: Reazzjonijiet li jissuġġerixxu ipersensittivita` (Tip I) imedjata kienu rrappurtati f'grupp żgħir ta' pazjenti fuq brivaracetam (9/3022) waqt żvillup kliniku.
English: Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe derivattiv ta' pyrrolidone ieħor jew wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: The risk of clinically relevant CYP3A4 interactions is considered to be low.
Maltese: Ir-riskju ta' interazzjonijiet ta' CYP3A4 rilevanti huwa kkonsidrat bħala baxx.
English: All packs are available in PVC/PCTFE - Aluminium blisters.
Maltese: Il-pakketti kollha ssibhom f' PVC/PCTFE - folji tal-aluminju.
English: Brivaracetam is primarily metabolized by hydrolysis of the amide moiety to form the corresponding carboxylic acid (approximately 60 % the elimination), and secondarily by hydroxylation on the propyl side chain (approximately 30 % the elimination).
Maltese: Brivaracetam huwa primarjament metabolized bil-idroliżi tal-parti amide biex jifforma l- carboxylic acid li jikkorispondi (approximament 60 % tal-eliminazzjoni), u sekondarjament bil- idroxilazzjoni talkatina tal-ġenb propyl side chain (approssimament 30 % tal-eliminazzjoni).
English: - Wash the oral syringe with water only (figure 13).
Maltese: - Aħsel is-siringa orali bl-ilma biss (figura 13).
English: In vitro, Brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose.
Maltese: In vitro, Brivaracetam jinhibixxi OAT3 b'nofs ilkonċentrazzjoni inhibitorja massima 42- il-darba ogħla minn Cmax fl-ogħla doża klinika.
English: Across all studies, 81.7 % of the patients who completed randomized studies were enrolled in the long-term open-label extension studies.
Maltese: 81.7 % tal-pazjenti li lestew studji randomizzati mill-istudji kollha, kienu mdaħħla f'studji ta' estenzjoni fit-tul open-label.
English: In clinical studies, brivaracetam was used as adjunctive therapy and when it was used with carbamazepine, it induced a dose-related increase in the concentration of the active metabolite, carbamazepine-epoxide (see section 4.5).
Maltese: F' studji kliniċi, brivaracetam kien użat bħala terapija aġġuntiva u meta użat ma' carbamazepine, indotta żieda relatata mad-doża fil-konċentrazzjoni tal-metabolit attiv, carbamazepine-epoxide (ara sezzjoni 4.5).
English: Metabolism and nutrition disorders
Maltese: Mard tal-Metaboliżmu u tan-Nutrizzjoni
English: Recommended starting dose 50 mg/day (or 100 mg/day)*
Maltese: Doża rakkomandata tal-bidu 50 mg/jum (jew 100 mg/jum)*
English: The safety profile in elderly patients appears to be similar to that observed in younger adult patients.
Maltese: Il-profil ta' sigurta` f'pazjenti anzjani jidher simili ta' dak osservat f'pazjenti adulti iżgħar.
English: In vitro, the hydroxylation of brivaracetam is mediated primarily by CYP2C19.
Maltese: In vitro, l-idroxilazzjoni ta' brivaracetam hija medjata primċiparjament b' CYP2C19.
English: Juvenile animals studies
Maltese: Studji fuq animali ġovanili
English: - St John's wort (also known as Hypericum perforatum) - a herbal medicine used to treat depression and anxiety as well as other conditions.
Maltese: - St John's wort (magħrufa wkoll bħala Hypericum perforatum) - mediċina magħmula tmill-pjanti li tintuża fit-trattament ta' depressjoni u anzjeta` kif ukoll kondizzjonijiet oħra.
English: Adults, adolescents and children weighing 50 kg or more - The recommended dose is from 25 mg to 100 mg taken twice a day .
Maltese: Adulti, adolexxenti u tfal li jiżnu 50 kg jew aktar - Id-doża rakkomandata hija bejn 25 mg u 100 mg darbtejn kuljum.
English: When brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum daily dose) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg), a reduction in estrogen and progestin AUCs of 27 % and 23 %, respectively, was observed without impact on suppression of ovulation.
Maltese: Meta brivaracetam ingħata flimkien f'doża ta' 400 mg/ġurnata (id-doppju tad-doża massima rrikkmandata ta' kuljum) ma' kontraċettiv orali li fih ethinylestradiol (0.03 mg) u levonorgestrel (0.15 mg), tnaqqis fl-AUCs ta' estrogen u progestin ta' 27% u 23%, rispettivament, kienet osservata mingħajr impatt fuq is-soppressjoni ta' ovulazzjoni.
English: In vitro interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3.
Maltese: Studji ta' interazzjonijiet in vitro li jiddeterminaw l-effetti inhibitorji potenzjali fuq transporters ikkonkludew li m'hemmx effetti klinikament rilevanti, ħlief għal OAT3.
English: Briviact 10 mg/ml solution for injection/infusion 5 ml vial is packed in a carton box of 10 vials.
Maltese: Briviact 10 mg/ml soluzzjoni għall-injezzjoni/infużjoni vjala ta' 5 ml huwa ppakkjat f'kartun li fihom 10 vjali.
English: Patients with rare heriditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti b'problemi ereditarji rari ta' intolleranza għal galactose, id-defiċjenza ta' lactase Lapp jew mal-assorbiment ta' glucose-galactose, m'għandhomx jieħdu din il-mediċina.
English: Other strong enzyme inducers (such as St John´s wort (Hypericum perforatum)) may also decrease the systemic exposure of brivaracetam.
Maltese: Mediċini oħra li jindottaw bis-saħħa l-enżimi (bħal St John´s wort (Hypericum perforatum)) jistgħu wkoll inaqqsu l-espozizzjoni sistemika ta' brivaracetam.
English: A study in subjects with severe renal impairment (creatinine clearance <30 ml/min/1.73 m² and not requiring dialysis) revealed that the plasma AUC of brivaracetam was moderately increased (+21 %) relative to healthy controls, while the AUC of the acid, hydroxy and hydroxyacid metabolites were increased 3-, 4-, and 21-fold, respectively.
Maltese: Studju f'persuni b'indeboliment sever renali (creatinine clearance <30 ml/min/1.73 m² u m'għandhomx bżonn dijaliżi) wrew li l-AUC tal-plażma ta' brivaracetam kienet miżjuda moderatament (+21 %) relattivament għal controls f'saħħithom, iżda l-AUC metaboliti aċidużi, idroxi u hydroxyacid kienu miżjuda 3-, 4-, u 21-fold, rispettivament.
English: The recommended maintenance dose is 100 mg/day.
Maltese: Id-doża ta' manteniment rakkomandata hi ta' 100 mg/jum.
English: Sodium acetate (trihydrate) Acetic acid, glacial (for pH-adjustment) Sodium chloride
Maltese: Sodium acetate (trihydrate) Acetic acid, glacial
English: Briviact may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) solution for injection or lactated Ringer's solution.
Maltese: Briviact jista' jiġi dilwit b'dawn is-soluzzjonijiet li ġejjin: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) soluzzjoni għall-injezzjoni jew lactated Ringer's solution.
English: Briviact solution for injection/infusion contains 0.83 mmol (or 19.14 mg) sodium per vial.
Maltese: Briviact soluzzjoni għall-injezzjoni/infużjoni fiha 0.83 mmol (jew 19.14 mg) sodium kull vjala.
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs), including brivaracetam, in several indications.
Maltese: Ħsibijiet u aġir ta' suwiċidju kienu rrappurtati f'pazjenti ttrattati b'mediċini ta' kontra l-epilessija (AEDs), inkluż brivaracetam, f'diversi indikazzjonijiet.
English: The active substance is brivaracetam.
Maltese: Is-sustanza attiva hija brivaracetam.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti b'problemi ereditarji rari ta' intolleranza ta' fructose m'għandhomx jieħdu din il-mediċina.
English: - Intravenous infusion: brivaracetam may be diluted in a compatible diluent and administered as a 15-minute intravenous infusion (see section 6.6).
Maltese: - Infużjoni ġol-vina: brivaracetam jista' jiġi dilwit f'dilwent kompatibbli u jingħata bħala infużjoni ġol-vina ta' 15-il minuta (ara sezzjoni 6.6).
English: In a pharmacokinetic study with a 3-week evaluation period and weekly fixed 3-step up-titration using the brivaracetam oral solution, 99 subjects aged 1 month to <16 years were evaluated.
Maltese: Fi studju farmakokinetiku b'perjodu ta' evalwazzjoni ta' 3 ġimgħat u b'żieda fissa fil-ġimgħa ta' 3 passi fit-titrazzjoni li uża s-soluzzjoni orali ta' brivaracetam, 99 individwu ta' età minn xahar sa <16il sena ġew evalwati.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet għal-ħażna wara d-dilwazzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: EXPIRY DATE
Maltese: Data ta' ftuħ
English: The clinical experience in patients ≥ 65 years is limited.
Maltese: .2) L-esperjenza klinika f'pazjenti ≥ 65 hija limitata.
English: The efficacy of brivaracetam for the adjunctive therapy of partial onset seizures (POS) was established in 3 randomized, double-blind, placebo-controlled, fixed-dose, multi-center studies in subjects 16 years of age and older.
Maltese: L'effikaċja ta' brivaracetam fit-terapija aġġuntiva ta' aċċessjonijiet partial onset (POS) kienet stabbilita f'tlett studji multi-ċentrali, b'doża fissa, ikkontrollati mill-plaċebo, double-blind u randomised f'pazjenti ta' 16-il sena u fuqhom.
English: Brivaracetam is weakly bound (≤ 20 %) to plasma proteins.
Maltese: Brivaracetam huwa marbut b'mod dgħajjef (≤20 %) mal-protejini fil-plażma.
English: The 300 ml glass bottle of Briviact is packed in a cardboard box containing a 10 ml oral syringe and a 5 ml oral syringe and an adaptor for the syringe.
Maltese: Il-flixkun tal-ħġieġ ta' 300 ml Briviact huwa ppakjat f' kaxxa tal-kartun li fiha siringa orali ta' 10 ml u siringa orali ta' 5 mL u adepter għas-siringa.
English: Briviact 10 mg film-coated tablets Briviact 25 mg film-coated tablets Briviact 50 mg film-coated tablets Briviact 75 mg film-coated tablets Briviact 100 mg film-coated tablets brivaracetam
Maltese: Briviact 10 mg pilloli miksija b'rita Briviact 25 mg pilloli miksija b'rita Briviact 50 mg pilloli miksija b'rita Briviact 75 mg pilloli miksija b'rita Briviact 100 mg pilloli miksija b'rita
English: Intravenous bolus: may be administered directly without dilution Intravenous infusion: may be administered over 15 minutes in a compatible diluent
Maltese: Bolus ġol-vina: tista' tingħata direttament mingħajr dilwazzjoni Infużjoni ġol-vina: tista' tingħata fuq 15-il minuta f'dilwent kompatibbli
English: The three pivotal double-blind placebo-controlled studies included 38 elderly patients aged between 65 and 80 years.
Maltese: Fi tlett studji importanti kkontrollati mill-plaċebo, double-blind ġew inklużi 38 pazjent anzjan ta' bejn il- 65 u t-80 sena.
English: Additional graduations at 0.25 ml and 0.75 ml starting at 0.25 ml up to 5 ml are shown.
Maltese: Jidhru gradazzjonijiet addizzjonali kull 0.25 mL u 0.75 mL li jibdew minn 0.25 mL sa 5 mL.
English: Gender There are no clinically relevant differences in the pharmacokinetics of brivaracetam by gender.
Maltese: Ġeneru M'hemmx differnzi klinikament rilevanti fil-farmakokinetika ta' brivaracetam skond il-ġeneru.
English: In juvenile dogs, the brivaracetam-induced changes at the exposure level 6- fold the clinical AUC were similar to those observed in adult animals.
Maltese: Fi klieb ġovanili, it-tibdiliet li ndotta brivaracetam b'livelli t'esponiment 6- darbiet aktar mill-esponiment AUC kliniku kien simili ta' dak osservat f'annimali adulti.
English: Excipient(s) with known effect: Each ml of solution for injection/infusion contains 3.8 mg sodium.
Maltese: Kull ml ta' soluzzjoni għall-injezzjoni/ infużjoni fiha 3.8 mg sodium.
English: The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).
Maltese: Is-soluzzjoni orali fiha methyl parahydroxybenzoate (E218), li tista' tikkawża reazzjonijet allerġiċi (possibilment aktar tard).
English: Each carton contains 10 vials.
Maltese: Kull pakkett fih 10 vjali.
English: Brivaracetam is eliminated primarily by metabolism and by excretion in the urine.
Maltese: Brivaracetam huwa eliminat prinċiparjament b'metaboliżmu u eskrezzjoni fl-awrina.
English: In controlled studies, the carbamazepine epoxide plasma concentration increased by a mean of 37 %, 62 % and 98 % with little variability at brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day respectively.
Maltese: F'studji kkontrollati, ilkonċentrazzjoni fil-plażma ta' carbamazepine epoxide żdiedet b'medja ta' 37%, 62% u 98% bi ftit tibdil b'dożi ta' brivaracetam ta' 50 mg/ġurnata, 100 mg/ġurnata u 200 mg/ġurnata rispettivament.
English: Briviact 75 mg are purple, oval, film-coated tablets of 13.0 mm x 7.3 mm and debossed with ‘u75' on one side.
Maltese: Briviact 75 mg huma vjola, ovali, pilloli miksija b'rita ta' 13.0 mm x 7.3 mm u mnaqqxa b' ‘u 75' fuq naħa waħda.
English: Briviact is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Maltese: Briviact huwa indikat bħala terapija aġġuntiva fit-trattament ta' aċċessjonijiet tat-tip partial onset kemm bi jew mingħajr ġeneralizzazzjoni sekondarja f'adulti, adolexxenti u tfal minn età ta' 4 snin b'epilessija.
English: Briviact contains lactose
Maltese: Briviact fih lactose
English: The primary endpoints in the phase 3 studies were the percent reduction in POS frequency over placebo and the 50 % responder rate based on 50 % reduction in POS frequency from baseline.
Maltese: Il-punti primarji fl-studji f'fażi 3 kienu il-perċentaġġ tat-tnaqqis fil-frekwenza POS fuq il-placebo u 50 % rata ta' rispons ibbażata fuq tnaqqis ta' 50 % fil-frekwenza ta' POS mill-linja bażi.
English: No clinical data are available in neonates.
Maltese: M'hemm l-ebda data klinika disponibbli fi trabi ta' twelid.
English: Briviact 100 mg are green-grey, oval, film-coated tablets of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Maltese: Briviact 100 mg huma ħodor-griżi, ovali, pilloli miksija b'rita ta' 14.5 mm x 8.1 mm u mnaqqxa b' ‘u 100' fuq naħa waħda.
English: The minimum extractible volume is 0.25 ml which is 2.5 mg of brivaracetam.
Maltese: Il-volum minimu li jista' jiġi estratt huwa 0.25 mL li huwa 2.5 mg ta' brivaracetam.
English: One vial of 5 ml contains 50 mg brivaracetam.
Maltese: Vjala waħda ta' 5 ml fiha 50 mg brivaracetam.