FrancophonIA/ELRC3.0 huggingface dataset:
English: Suicidal ideation has been reported in 0.3 % (3/1099) brivaracetam patients and 0.7 % (3/459) placebo patients.
Maltese: Ħsibijiet ta' suwiċidju kienet irrapurtata f' 0.3% (3/1099) tal-pazjenti fuq brivaracetam u 0.7% (3/459) tal- pazjenti fuq plaċebo.
English: The total plasma clearance in patients was estimated to 3.6 L/h.
Maltese: Il-eliminazzjoni totali fil-plażma fil-pazjenti kien stmat għal 3.6 L/siegħa.
English: Adverse reactions from clinical trials
Maltese: Reazzjoni avversi minn provi kliniċi
English: Table 2: Key Efficacy Outcomes for Partial Onset Seizure Frequency per 28 Days Study
Maltese: Importanti tal-effikaċja miġbura għall-Frekwenza tal-Aċċessjonijiet Partial Onset kull 28 Ġurnata
English: Briviact tablets are packaged in blister packs supplied in cardboard boxes containing either 14, 56, 14 x 1 or 100 x 1 film-coated tablets or in multipacks containing 168 (3 packs of 56) film-coated tablets.
Maltese: Il-pilloli Briviact huma ppakkjati f' folji li ssibhom b'kaxxi tal-kartun li fihom jew 14, 56, 14 x 1 jew 100 x 1 pilloli miksija b'rita jew f'pakketti multipli li fihom 168 (3 pakketti ta' 56) pilloli miksija b'rita.
English: Brivaracetam was administered at weekly increasing doses of approximately 1 mg/kg/day, 2 mg/kg/day, and 4 mg/kg/day.
Maltese: Brivaracetam ingħata f'dożi li żdiedu kull ġimgħa ta' madwar 1 mg/kg/jum, 2 mg/kg/jum, u 4 mg/kg/jum.
English: Brivaracetam plasma concentrations may increase when coadministered with CYP2C19 strong inhibitors (e.g. fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19-mediated interaction is considered to be low.
Maltese: Konċentrazzjonijiet tal-plażma ta' brivaracetam jistgħu jiżdiedu meta jingħataw flimkien ma' inhibituri b'saħħithom ta' CYP2C19 (eż. fluconazole, fluvoxamine), imma r-riskju ta' interazzjoni klinikament rilevanti medjata minn CYP2C19-mediated hija kkonsidrata baxxa.
English: n = randomised patients who received at least 1 dose of study medication ~ Dose not studied Statistically significant Approximately 20 % of the patients were on concomitant levetiracetam The primary outcome for N01252 did not achieve statistical significance based on the sequential testing procedure.
Maltese: n = pazjenti randomizzati li rċievew mill-inqas doża waħda ta' mediċina tal-istudju ~ Doża mhux studjata Statistikament sinifikanti Bejn wieħed u ieħor 20 % tal-pazjenti kienu fuq fl-istess ħin fuq levetiracetam ir-riżultat primarju għal N01252 ma laħqitx sinifikanza klinika ibbażata fuq poċedura ta' testijiet sekwenzjali.
English: 50 - 200 mg/day
Maltese: Medda tad-doża terapewtika 50 - 200 mg/jum
English: n = randomised patients who received at least 1 dose of study medication ~ Dose not studied Statistically significant Approximately 20 % of the patients were on concomitant levetiracetam The primary outcome for N01252 did not achieve statistical significance based on the sequential testing procedure, The 100 mg/day dose was nominally significant.
Maltese: n = pazjenti randomizzati li rċievew mill-inqas doża waħda ta' mediċina tal-istudju ~ Doża mhux studjata Statistikament sinifikanti Bejn wieħed u ieħor 20 % tal-pazjenti kienu fuq fl-istess ħin fuq levetiracetam ir-riżultat primarju għal N01252 ma laħqitx sinifikanza klinika ibbażata fuq poċedura ta' testijiet sekwenzjali, id-doża ta' 100 mg/ġurnata kienet sinifikanti nominalment.
English: Of the 130 elderly subjects enrolled in the brivaracetam phase 2/3 development program (44 with epilepsy), 100 were 65-74 years of age and 30 were 75-84 years of age.
Maltese: Mill -130 persuni anzjani li ħadu sehem fil-programm ta'żvillup f'fażi 2/3 ta' brivaracetam (44 blepilessija), 100 kellhom 65-74 sena u 30 kellhom 75-84 sena.
English: Common: may affect up to 1 in 10 people - flu - feeling very tired (fatigue) - convulsion, a feeling of ‘spinning' (vertigo) - feeling and being sick, constipation - pain or discomfort at the injection or infusion site - depression, anxiety, not being able to sleep (insomnia), irritability - infections of the nose and throat (such as the ‘common cold'), cough - decrease appetite
Maltese: Komuni: jistgħu jaffetwaw minn 1 minn 10 persuni - influwenza - tħossok vera għajjien (għajja) - aċċessjoni, tħoss kollox idur bik (vertigo) - tħossok imdardar u tirremetti, stitikezza depressjoni, anzjeta`, ma tkunx tista' torqod (insomnja), irritabilita` - infezzjonijiet tal-imnieħer u l-gerżuma (bħal riħ), sogħla tnaqqis fl-aptit
English: No adverse liver changes were seen in rats and monkeys following chronic administration of brivaracetam at 5- and 42fold the clinical AUC exposure.
Maltese: Ebda tibil fil-fwied ma ġie osservat fil-firien jew xadini wara t-teħid kroniku ta' brivaracetam f' 5- u 42-il darba l-esponiment kliniku AUC.
English: Upper respiratory tract infections, cough
Maltese: Infezzjonijiet tat-tratt respiratorju ta' fuq, sogħla
English: Neutropenia
Maltese: Nutropenja
English: The solution for injection/infusion contains 0.83 mmol (or 19.14 mg) sodium per vial.
Maltese: Is-soluzzjoni għall-injezzjoni/infużjoni fiha 0.83 mmol (jew 19.14 mg) sodium kull vjala.
English: Briviact 25 mg are grey, oval, film-coated tablets of 8.9 mm x 5.0 mm and debossed with ‘u25' on one side.
Maltese: Briviact 25 mg huma griżi, ovali, pilloli miksija b'rita ta' 8.9 mm x 5.0 mm u mnaqqxa b' ‘u 25' fuq naħa waħda.
English: No data available
Maltese: Dejta mhux disponibbli
English: Read the package leaflet before use.
Maltese: Mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: 50% Responder rate
Maltese: 50 % Rata ta' Nies li Wiegbu
English: The other ingredients are: sodium acetate (trihydrate), acetic acid, glacial, sodium chloride, water for injection.
Maltese: L-eċċipjenti l-oħra huma: sodium acetate (trihydrate), acetic acid, glacial, sodium chloride, ilma għallinjezzjoni.
English: In a pharmacokinetic and pharmacodynamic interaction study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy subjects, there was no pharmacokinetic interaction but brivaracetam approximately doubled the effect of alcohol on psychomotor function, attention and memory.
Maltese: F'studju farmakokinetiku u farmakodinamiku ta' interazzjoni bejn doża singola ta 200 mg brivaracetam u infużżjoni kontinwa ta' ethanol 0.6 g/L f'suġġetti adulti, ma kien hemm ebda interazzjoni farmakokinetika iżda brivaracetam bejn wieħed u ieħor irdoppjaw l-effett tal-alkoħol fuq funzjoni psikomotorili, attenzjoni u memorja.
English: The effect of the interactions on the plasma concentration is summarised in table 1 (increase is indicated as “↑” and decrease as “↓”, area under the plasma concentration versus time curve as “AUC”, maximum observed concentration as Cmax).
Maltese: l-effett tal-interazzjoni fuq il-konċentrazzjoni fil-plażma huwa elenkati f' tabella 1 (iż-żieda hija indikata bħala “↑” u t-tnaqqis “↓”, erja taħt konċentrazzjoni tal-plażma versus lil-ħin bħala “AUC”, lil-konċentrazzjoni massima osservata bħala Cmax).
English: 14 film-coated tablets 56 film-coated tablets 100 x 1 film-coated tablet 14 x 1 film-coated tablet
Maltese: 14 pilloli miksija b'rita 56 pilloli miksija b'rita 100 x 1 pillola miksija b'rita 14 x 1 pilloli miksija b'rita
English: Briviact 10 mg/ml oral solution brivaracetam
Maltese: TAL-PRODOTT MEDIĊINALI Briviact 10 mg/ml soluzzjoni orali brivaracetam
English: Briviact oral solution is provided with a 5 ml and a 10 ml oral dosing syringe with their adaptor.
Maltese: Briviact soluzzjoni orali hija pprovduta b'siringa ta' dożaġġ orali ta' 5 mL u 10 mL mal-adapter tagħhom.
English: Brivaracetam exhibits linear and time-independent pharmacokinetics with low intra- and inter-subject variability, and features complete absorption, very low protein binding, renal excretion following extensive biotransformation, and pharmacologically inactive metabolites.
Maltese: Brivaracetam juri farmakokinetika linejari u indipendenti mil-ħin b'varjabilita` baxxa kemm fl-istess pazjent kif ukoll bejn il-pazjenti, u juri assorbiment komplet, rabta mal-proteijini baxxa ħafna, eliminazzjoni millkliewi wara bijo-trasformazzjoni estensiva, u metaboliti farmakoloġikament inattivi.
English: Briviact 75 mg film-coated tablets Each 75 mg film-coated tablet contains 283 mg lactose.
Maltese: Briviact 75 mg pilloli miksija b'rita Kull pillola miksija b'rita 75 mg fiha 283 mg lactose.
English: Briviact 50 mg are yellow, oval, film-coated tablets of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Maltese: Briviact 50 mg huma sofor, ovali, pilloli miksija b'rita ta' 11.7 mm x 6.6 mm u mnaqqxa b' ‘u 50' fuq naħa waħda.
English: Findings not observed in clinical studies, but seen in the repeated-dose toxicology dog studies at exposure similar to the clinical plasma AUC, were hepatotoxic effects (mainly porphyria).
Maltese: Sejbiet li ma ġewx osservati f'studji kliniċi, imma dehru f' l-istudji fil-klieb ta' tossikoloġija b'doża ripetuta b'esponimenti simili għal AUC fil-plażma klinika, kienu effetti epatotossiċi (prinċipalment porphyria).
English: B. PACKAGE LEAFLET
Maltese: Tabella 2: Riżultati
English: The discontinuation rate due to adverse reactions was 3.5 %, 3.4 % and 4.0 % for patients randomized to brivaracetam at respectively the dose of 50 mg/day, 100 mg/day and 200 mg/day and 1.7% for patients randomized to placebo.
Maltese: Ir-rata ta' diskontinwazzjoni minħabba avvenimenti avversi kienet 3.5%, 3.4% u 4.0%% għal pazjenti randomizzati fuq brivaracetam rispettivament f'doża ta' 50 mg/ġurnata, 100 mg/ġurnata u 200 mg/ġurnata u 1.7% għal pazjenti fuq plaċebo.
English: The 5 ml oral syringe has 2 overlapping graduations: in steps of 0.25 ml and in steps of 0.1 ml.
Maltese: Is-siringa ta' dożaġġ orali ta' 5 mL għandha żewġ gradazzjonijiet li jiltaqgħu f'ċerti punti: f'passi ta' 0.25 mL u f'passi ta' 0.1 mL.
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a box also containing a 5 ml and 10 ml graduated oral dosing syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Maltese: Flixkun tal-ħġieġ kulur ambra ta' 300 ml (tip III) b' tap abjad resistanti għat-tfal (polypropylene) f'kaxxa li fiha wkoll siringa ta' 5 mL u 10 ml għad-dożaġġ immarkata (polypropylene, polyethylene) u edepter għas-siringa (polyethylene).
English: Effects of brivaracetam on other medicinal products Brivaracetam given 50 or 150 mg/day did not affect the AUC of midazolam (metabolised by CYP3A4).
Maltese: Brivaracetam meta jingħata kemm f'dożi ta 50 jew 150 mg/ġurnata ma kellux effett fuq l-AUC ta' midazolam (immetabolizzat minn CYP3A4).
English: In patients who were followed up in the open-label extension studies for up to 8 years, the safety profile was similar to that observed in the short-term, placebo-controlled studies.
Maltese: F'pazjenti li kienu ġew segwiti sa 8 snin f'studji ta' estenzjoni open-label, il-profil ta' sigurta` kienet simili ta' dik osservata f'studji kkontrollati minn plaċebo fuq medda qasira.
English: Brivaracetam was evaluated in these patients in a short term openlabel pharmacokinetic study and an ongoing open-label extension study, in 16 subjects from 1 month to <4 years of age (see section 5.2).
Maltese: Brivaracetam kien evalwat f'dawn il-pazjenti f'studji talfarmakokinetika open label mhux twil u f'studju ta' estenzjoni open label li għadu għaddej, f'16il pazjent ta' bejn xahar u <4 snin (ara sezzjoni 5.2).
English: Potential interactions between brivaracetam (50 mg/day to 200 mg/day) and other AEDs were investigated in a pooled analysis of plasma drug concentrations from all phase 2-3 studies in a population pharmacokinetic analysis of placebo-controlled phase 2-3 studies, and in dedicated drugdrug interaction studies (for the following AEDs: carbamazepine, lamotrigine, phenytoin and topiramate).
Maltese: Interazzjonijiet potenzjali bejn brivaracetam (50 mg/ġurnata sa 200 mg/ġurnata) u AEDs oħra kienu investigati f'analiżi miġbura ta' konċentrazzjonijiet tal-mediċina fil-plażma mill-istudji kollha ta'fażi 2-3 u f'analiżi ta' farmakokinetika fil-popolazzjoni f' studji f'fażi 2-3 ikkontrollati mill-plaċebo, u f'studji ddedikati ta' interazzjoni bejn mediċin u oħra (għal dawn l-AEDs li ġejjin: carbamazepine, lamotrigine, phenytoin u topiramate).
English: In juvenile rats, brivaracetam exposure levels 6- to 15-fold the clinical AUC exposure at the maximum recommended dose induced developmental adverse effects (i.e. mortality, clinical signs, decreased body weight and lower brain weight).
Maltese: F'firien ġovanili, livell t'esponimentta' brivaracetam assoċjat 6- sa 15-il darba l-esponiment AUC kliniku fid-doża massima rikkmandata indottaw effetti avversi fl-izvillup (i.e. mortalita`, sinjali kliniċi, tnaqqis fil-piz tal-ġisem u piz tal-moħħ baxx).
English: Each ml contains 10 mg brivaracetam.
Maltese: U KWANTITATTIVA Kull ml fih 10 mg brivaracetam.
English: The 100 mg/day dose was nominally significant.
Maltese: Id-doża ta' 100 mg/ġurnata kienet sinifikanti nominalment.
English: Potential interactions between brivaracetam (50 mg/day to 200 mg/day) and other AEDs were investigated in a pooled analysis of plasma drug concentrations from all phase 2-3 studies, in a population pharmacokinetic analysis of placebo-controlled phase 2-3 studies, and in dedicated drugdrug interaction studies (for the following AEDs: carbamazepine, lamotrigine, phenytoin and topiramate).
Maltese: Interazzjonijiet potenzjali bejn brivaracetam (50 mg/ġurnata sa 200 mg/ġurnata) u AEDs oħra kienu investigati f'analiżi miġbura ta' konċentrazzjonijiet tal-mediċina fil-plażma mill-istudji kollha ta'fażi 2-3 u f'analiżi ta' farmakokinetika fil-popolazzjoni f' studji f'fażi 2-3 ikkontrollati mill-plaċebo, u f'studji ddedikati ta' interazzjoni bejn mediċina u oħra (għal dawn l-AEDs li ġejjin: carbamazepine, lamotrigine, phenytoin u topiramate).
English: In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults.
Maltese: Fi studji open-label, mhux ikkontrollati u fuq perjodu twil ta' żmien, il-ħsibijiet ta' suwiċidju kienu rrappurtati f'4.7 % tal-pazjenti pedjatriċi (aktar komuni fl-adolexxenti) meta mqabbla ma' 2.4 % ta' adulti u disturbi fl-imġiba kienu rrappurtati f'24.8 % tal-pazjenti pedjatriċi meta mqabbla ma' 15.1 % ta' adulti.
English: 50 mg/day 100 mg/day 200 mg/day
Maltese: 100 mg/jum2 mg/kg/jum
English: How to store Briviact
Maltese: X'fih Briviact
English: Open label extension studies
Maltese: Studji ta' estenzjoni open-label
English: Briviact oral solution contains methyl parahydroxybenzoate, sodium and sorbitol Briviact oral solution contains: - methyl parahydroxybenzoate (E218) - this may cause allergic reactions (possibly delayed).
Maltese: Briviact soluzzjoni orali fih methyl parahydroxybenzoate, sodium u sorbitol Briviact soluzzjoni orali fih: - methyl parahydroxybenzoate (E218) - dan jista' jikkawża reazzjonijiet allerġiċi (possibilment aktar tard). - 1.16 milligrams sodium kull millilitre.
English: Purple, oval film-coated tablets with dimensions of 13.0 mm x 7.3 mm debossed with ‘u75' on one side.
Maltese: Pilloli miksija b'rita vjola, ovali, ta' dijametru ta' 13.0 mm x 7.3 mm u mnaqqxa b' ‘u75' fuq naħa waħda.
English: The following table summarises the recommended posology for children from 4 years of age and adolescents.
Maltese: It-tabella li ġejja tagħti sommarju tal-pożoloġija rakkomandata għal tfal minn età ta' 4 snin u adolexxenti.
English: - 75 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
Maltese: - 75 mg pilloli miksija b'rita: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, terra, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172).
English: Uncommon: may affect up to 1 in 100 people - allergic reactions - abnormal thinking and/or loss of touch with reality (psychotic disorder), being aggressive,
Maltese: Mhux komuni: jista' jaffetwa minn 1 minn 100 persuna - reazzjonijiet allerġiċi - ħsibijiet anormali u/jew tinqata' mir-realtà (mard psikotiku), tkun aggressiv, eċitament nervuż
English: 10 mg/ml solution for injection/infusion is packed in 6 ml nominal capacity glass vials (type I) with siliconized bromobutyl rubber stoppers and sealed with an aluminium/polypropylene tear off cap. Each single use vial contains an extractable volume of not less than 5.0 ml of solution for injection/infusion.
Maltese: Is-soluzzjoni għall-injezzjoni 10 mg/ml hija ppakkjata f' vjali tal-ħġieġ ta' kapaċita` nominali ta' 6 ml (type I) b'tappijiet tal-gomma ta' bromobutyl silikonizzati u ssiġillati b' tapp li jitqatta talaluminju/polypropylene.
English: - Each ml contains 10 mg brivaracetam - Each 5 ml vial contains 50 mg brivaracetam
Maltese: - Kull ml fih 10 mg brivaracetam - Kull vjala ta' 5 ml vial fiha 50 mg brivaracetam
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara EXP.
English: Briviact 50 mg film-coated tablets Each 50 mg film-coated tablet contains 189 mg lactose.
Maltese: Briviact 50 mg pilloli miksija b'rita Kull pillola miksija b'rita 50 mg fiha 189 mg lactose.
English: Somnolence and dizziness have been reported in a healthy subject taking a single dose of 1,400 mg of brivaracetam.
Maltese: Kienu rrappurtati nagħas u sturdament f'persuna f'saħħitha li ħadet doża singola ta' 1,400 mg ta' brivaracetam.
English: - Intravenous bolus: brivaracetam may be administered as an intravenous bolus without dilution.
Maltese: - Doża bolus ġol-vina: brivaracetam jista' jingħata bħala bolus ġol-vina mingħajr ma jiġi dilwit.
English: From entry into the randomized studies,5.3 % of the subjects exposed to brivaracetam for 6 months (n=1,500) were seizure free compared to 4.6 % and 3.7 % for subjects exposed for 12 months (n=1,188) and 24 months (n=847), respectively.
Maltese: Mid-dħul ġol-istudji randomizzati, 5.3 % tal-pazjenti esposti għal brivaracetam għal 6 xhur (n=1,500) kienu ħielsa mill-aċċessjonijiet meta mqabbla ma' 4.6 % u 3.7 % tal-pazjenti esposti għal 12-il xahar (n=1,188) u 24 xahar (n=847), rispettivament.
English: Briviact is administered as an injection or infusion into a vein by a doctor or a nurse.
Maltese: Briviact jingħata bħala injezzjoni jew infużjonu ġol-vina minn tabib jew infermiera.
English: - 100 mg film-coated tablets: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide black (E172).
Maltese: - 100 mg pilloli miksija b'rita: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, terra, iron oxide yellow (E172), iron oxide black (E172).
English: A nasogastric tube or a gastrostomy tube may be used when administering brivaracetam oral solution.
Maltese: Tubu nażogastriku jew tubu għal gastrostomy jista' jintuża meta tittieħed brivaracetam soluzzjoni orali.
English: The other ingredients are:
Maltese: Persuni anzjani:
English: Oral dosing syringe (10 ml graduated every 0.25 ml) with an adaptor, recommended for use by patients weighing more than 20 kg or needing a dose between 50 mg and 100 mg (5 ml to 10 ml) brivaracetam per administration.
Maltese: Siringa ta' dożaġġ orali (10 mL gradata kull 0.25 mL) b'adapter, rakkomandata għall-użu minn pazjenti li jiżnu aktar minn 20 kg jew li għandhom bżonn doża ta' bejn 50 mg u 100 mg (5 mL sa 10 mL) brivaracetam kull għotja.
English: As from the 1 ml graduation mark, each graduation corresponds to 0.25 ml which is 2.5 mg of brivaracetam.
Maltese: Mill-marka ta' gradazzjoni ta' 1 mL, kull gradazzjoni tikkorrispondi għal 0.25 mL li huwa 2.5 mg ta' brivaracetam.
English: Brivaracetam did not show any dependence potential in rats.
Maltese: Brivaracetam ma weriex potenzjal għal dipendenza fil-firien.
English: Briviact 10 mg film-coated tablets Each 10 mg film-coated tablet contains 88 mg lactose.
Maltese: Briviact 10 mg pilloli miksija b'rita Kull pillola miksija b'rita 10 mg fiha 88 mg lactose.
English: Brivaracetam is cleared by multiple pathways including renal excretion, non-CYP-mediated hydrolysis and CYP-mediated oxidations.
Maltese: Brivaracetam huwa mneħħi b'modi differenti inkluż eskrezzjoni mill-kliewi, idroliżi mhux medjat minn CYP u oxidazzjonijiet medjati minn CYP.
English: Brivaracetam is rapidly and completely absorbed after oral administration and the absolute bioavailablity is approximately 100 %.
Maltese: Brivaracetam huwa assorbit malajr u kompletament wara t-teħid mill-ħalq u l-bijodisponibbilta` hija approssimament 100 %.
English: However, as a high proportion of subjects (26%) discontinued from the open-label studies due to lack of efficacy, a selection bias may have occurred, as the subjects who stayed in the study responded better than those who have terminated prematurely.
Maltese: Madanakollu, peress li proporzjon għoli ta' persuni (26%) waqfu mill-istudji open-label minħabba nuqqas ta' effikaċja, seta' kien hemm diżgwid fis- selezzjoni , peress li l-persuni li baqgħu fl-istudju rrispondew aħjar minn dawk li waqfu qabel il-waqt.
English: In comparison, plasma clearance was estimated at 3.58 L/h in adult patients (70 kg body weight).
Maltese: Bħala paragun, l-eliminazzjoni fil-plażma kienet stmata li kienet ta' 3.58 L/ siegħa f'pazjenti adulti (piż tal-ġisem ta' 70 kg).
English: In healthy subjects, coadministration with the strong enzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 45 %.
Maltese: F'pazjenti f'saħħithom, meta jingħata flimkien ma' rifampicin li tindotta l-enżimi bil-qawwa (600 mg/ġurnata għal 5 tijiem), inaqqas l-erja taħt il-kurva tal-konċentrazzjonijiet tal-plażma ta' brivaracetam (AUC) b' 45%.
English: Briviact 75 mg tablets brivaracetam
Maltese: TAL-PRODOTT MEDIĊINALI Briviact 75 mg pilloli brivaracetam
English: Coadministration with a high-fat meal slowed down the absorption rate (median tmax 3 h) and decreased the maximum plasma concentration (37 % lower) of brivaracetam, while the extent of absorption remained unchanged.
Maltese: It-teħid flimkien ma' ikla għolja fix-xaħam baxxa r-rata ta' assorbiment (tmax medju 3 sigħat) u naqqas il-konċentrazzjoni massima fil-plażma (37 % iżjed baxxa) ta' brivaracetam, iżda l-livell ta' assorbiment baqa' ma nbidilx.
English: Briviact 10 mg/ml oral solution
Maltese: IL-PRODOTT MEDIĊINALI Briviact 10 mg/ml soluzzjoni orali
English: One full 10 ml oral dosing syringe corresponds to 100 mg of brivaracetam.
Maltese: Siringa ta' dożaġġ orali waħda ta' 10 mL sħiħa tikkorrispondi għal 100 mg ta' brivaracetam.
English: Briviact 10 mg film-coated tablets Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Maltese: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
English: Briviact 100 mg tablets brivaracetam
Maltese: TAL-PRODOTT MEDIĊINALI Briviact 100 mg pilloli brivaracetam
English: Briviact 100 mg film-coated tablets Each 100 mg film-coated tablet contains 377 mg lactose.
Maltese: Briviact 100 mg pilloli miksija b'rita Kull pillola miksija b'rita 100 mg fiha 377 mg lactose.
English: (not for packsizes 14 x1 and 100 x 1 film-coated tablet)
Maltese: (tħalla barra mill-pakketti ta' 14 pilloli miksija b'rita)
English: Doses in patients from 4 years of age were defined by weight-based dose adaptations which have been established to achieve similar plasma concentrations to the ones observed in adults taking efficacious doses (section 5.2).
Maltese: Dożi f'pazjenti minn età ta' 4 snin ġew definiti b'adattamenti fid-doża bbażati fuq il-piż li ġew stabbiliti biex jinkisbu konċentrazzjonijiet fil-plażma simili għal dawk osservati f'adulti li jieħdu dożi effikaċi (sezzjoni 5.2).
English: Briviact 50 mg film-coated tablets Polyvinyl alcohol
Maltese: Briviact 50 mg pilloli miksija b'rita Polyvinyl alcohol