FrancophonIA/ELRC3.0 huggingface dataset:
English: Oral dosing syringe (5 ml graduated every 0.1 ml) with an adaptor, recommended for use by patients weighing less than 20 kg or needing a maximum of 50 mg (5 ml) brivaracetam per administration.
Maltese: Siringa ta' dożaġġ orali (5 mL gradata kull 0.1 mL) b'adaptor, rakkomandata għall-użu minn pazjenti li jiżnu inqas minn 20 kg jew li għandhom bżonn massimu ta' 50 mg (5 mL) brivaracetam kull għotja.
English: The adverse reactions most frequently resulting in discontinuation of brivaracetam therapy were dizziness (0.8 %) and convulsion (0.8 %).
Maltese: Ir-reazzjoni avversa li l-iżjed frekwentament iwassal għal diskontinwazzjoni ta' terapija b'brivaracetam kienu sturdament (0.8%) u aċċessjonijiet
English: Green-grey, oval film-coated tablets with dimensions of 14.5 mm x 8.1 mm and debossed with ‘u100' on one side.
Maltese: Pilloli miksija b'rita ħadra fil-griż, ovali, ta' dijametru ta' 14.5 mm x 8.1 mm u mnaqqxa b' ‘u100' fuq naħa waħda.
English: Children (from 4 years of age) and adolescents weighing less than 50 kg The recommended starting dose is 1 mg/kg/day.
Maltese: Tfal (minn età ta' 4 snin) u adolexxenti li jiżnu inqas minn 50 kg Id-doża tal-bidu rakkomandata hi ta' 1 mg/kg/jum.
English: Figure 1 shows the percentage of patients (excluding patients with concomitant levetiracetam) by category of reduction from baseline in POS frequency per 28 days in all 3 studies.
Maltese: Figura 1 turi l-perċentaġġ ta' pazjenti (eskluż il-pazjenti fuq levetiracetam ukoll) bil-kategorija ta' tnaqqis mill-linja bażi f'frekwenza POS kull 28 ġurnata fit-3 studji kollha.
English: In all controlled and uncontrolled trials in patients with epilepsy, 2,388 subjects have received brivaracetam, of whom 1,740 have been treated for ≥ 6 months,1,363 for ≥ 12 months, 923 for ≥ 24 months and 569 for ≥ 60 months (5 years).
Maltese: F'kull prova kontrollata u mhux kontrollata f'pazjenti bl'epilessija, 2388 persuna ħadu brivaracetam, li minnhom 1740 kienu kkurati għal ≥6 xhur,1363 għal ≥12 xhur, 923 għal ≥24 xhur u 569 għal ≥60 xhur (5 snin).
English: Influence of brivaracetam on AED plasma concentration
Maltese: Influwenza ta' brivaracetam fuq konċentrazzjonijiet ta' AED's fil-plasma
English: Immune system disorders Uncommon
Maltese: Mard tas-sistema immuni Mhux komuni
English: A long-term, uncontrolled, open-label safety study included children (from 4 years to less than 16 years) who continued treatment after completing the PK study (see section 5.2) and children directly enrolled into the safety study.
Maltese: Studju tas-sigurtà fit-tul, mingħajr kontroll u open-label inkluda tfal (minn età ta' bejn 4 snin sa inqas minn 16-il sena) li komplew bil-kura wara li lestew l-istudju PK (ara sezzjoni 5.2) u tfal li rreġistraw direttament fl-istudju tas-sigurtà.
English: A 40 % decrease in steady-state plasma concentration has been estimated across a body weight range from 46 kg to 115 kg.
Maltese: Tnaqqis ta' 40 % fil-konċentrazzjonijiet steady-state kien stmat f'medda ta' piz tal-ġisem minn 46 kg sa 115 kg. Madanakollu, din mhix ikkonsidrata bħala differenza klinikament rilevanti.
English: Apart from dose-dependent increases in incidences of somnolence and fatigue brivaracetam 50 mg/day and 100 mg/day had a similar safety profile including CNSrelated AEs and with long-term use.
Maltese: Minn barra żiediet fl-inċidenza ta' nagħas u għajja dipendenti fuq id-doża, brivaracetam 50 mg/ġurnata u 100 mg/ġurnata kellhom profil ta' sigurta` simili inkluż reazzjonijiet avversi relatati mas-CNS b'użu fit-tul.
English: Animal studies did not detect any teratogenic potential of brivaracetam (see section 5.3).
Maltese: Studji fuq lannimali ma sabu ebda potenzjal teratoġeniku għal brivaracetam (ara sezzjoni 5.3)
English: Brivaracetam plasma concentrations are decreased when coadministered with strong enzyme inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required (see table 1).
Maltese: Konċentrazzjonijiet tal-plażma ta' brivaracetam kienu mnaqqsa meta ngħata flimkien ma' AEDs li jindottaw l-enżimi bil-qawwa (carbamazepine, phenobarbital, phenytoin) imma m'hemmx bżonn aġġustament fid-doża ara tabella1).
English: Embryotoxicity was observed in rabbits at a maternal toxic dose of brivaracetam with an exposure level 8-fold the clinical AUC exposure at the maximum recommended dose.
Maltese: Fil-fniek, kien osservat tossiċita` għal embriju f'doża tossika għall-omm b'livell t'esponiment 8- darbiet l-esponiment AUC kliniku fid-doża massima rrikkmandata.
English: Briviact 25 mg film-coated tablets Each 25 mg film-coated tablet contains 94 mg lactose.
Maltese: Briviact 25 mg pilloli miksija b'rita Kull pillola miksija b'rita 25 mg fiha 94 mg lactose.
English: Antiepileptic drugs
Maltese: GĦAMLA FARMAĊEWTIKA
English: Briviact 10 mg tablets brivaracetam
Maltese: TAL-PRODOTT MEDIĊINALI Briviact 10 mg Pilloli brivaracetam
English: The hydroxyacid metabolite did not reveal any safety concerns in non clinical studies.
Maltese: F'studji mhux kliniċi il-metabolit hydroxyacid ma żvelax xi problemi fis-sigurta`.
English: Both metabolites, are further metabolised forming a common hydroxylated acid formed predominantly by hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9).
Maltese: Iż-żewġt metaboliti, huma mmetabolizzati aktar u jiffurmaw hydroxylated acid komuni fformat b'mod predominanti b'idroxylazzjoni ta' katina tal-ġenb propyl fuq il-metabolit carboxylic acid (il-biċċa l-kbira minn CYP2C9).
English: The hydrolysis of the amide moiety leading to the carboxylic acid metabolite (34 % of the dose in urine) is supported by hepatic and extra-hepatic amidase.
Maltese: L-idroliżi tal-parti amide iwassal għal metablite ta' carboxylic acid metabolite (34 % tad-doża fl-awrina) huwa mgħajjun minn amidase fil-fwied u barra mill-fwied.
English: Children (from 4 years of age) and adolescents weighing 50 kg or more
Maltese: Tfal (minn età ta' 4 snin) u adolexxenti li jiżnu inqas minn 50 kg
English: Volumes of oral solution to be taken per administration
Maltese: Mard ġenerali u kondizzjonijiet tas-sit ta' amministrazzjoni
English: Briviact 25 mg tablets brivaracetam
Maltese: TAL-PRODOTT MEDIĊINALI Briviact 25 mg pilloli brivaracetam
English: Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day and 4 mg/kg/day.
Maltese: Abbażi tar-rispons ta' pazjent individwali, id-doża tista' tiġi aġġustata fil-medda ta' doża effettiva ta' bejn 1 mg/kg/jum u 4 mg/kg/jum.
English: Briviact with alcohol - Combining this medicine with alcohol is not recommended.
Maltese: Briviact mal-alkoħol - Mhux irrikkmandat li tħallat din il-mediċina mal-alkoħol.
English: Briviact 10 mg/ml solution for injection/infusion brivaracetam
Maltese: TAL-PRODOTT MEDIĊINALI Briviact 10 mg/ml soluzzjoni għall-injezzjoni/infużjoni brivaracetam
English: Concomitant treatment with levetiracetam
Maltese: Trattament flimkien ma' levetiracetam
English: Therapeutic dose range
Maltese: TAL-PRODOTT MEDIĊINALI
English: One full 5 ml oral dosing syringe corresponds to 50 mg of brivaracetam.
Maltese: Siringa ta' dożaġġ orali waħda ta' 5 mL sħiħa tikkorrispondi għal 50 mg ta' brivaracetam.
English: No dose adjustment is needed in patients with impaired renal function (see section 5.2).
Maltese: M'hemmx bżonn aġġustament tad-doża f'pazjenti b'impediment fil-funzjoni renali (ara sezzjoni 5.2).
English: * Based on physician assessment of need for seizure control.
Maltese: * Ibbażata fuq valutazzjoni ta' tabib tal-bżonn għal kontroll ta' aċċessjonijiet.
English: Briviact 50 mg tablets brivaracetam
Maltese: TAL-PRODOTT MEDIĊINALI Briviact 50 mg pilloli brivaracetam
English: - Take the oral syringe out of the adaptor (figure 10).
Maltese: - Oħroġ is-siringa orali mill-adepter (figura 10).
English: Briviact 100 mg film-coated tablets Polyvinyl alcohol
Maltese: Briviact 10 mg pilloli miksija b'rita Polyvinyl alcohol
English: In rats, there was no effect on fertility with brivaracetam (see section 5.3).
Maltese: Fil-firien ma kien hemm ebda effett fuq il-fertilita` b' trattament ta'brivaracetam (ara sezzjoni 5.3).
English: EU/1/15/1073/017 14 film-coated tablets EU/1/15/1073/018 56 film-coated tablets EU/1/15/1073/019 100 x 1 film-coated tablet EU/1/15/1073/027 14 x 1 film-coated tablet
Maltese: EU/1/15/1073/017 14 pilloli miksija b'rita EU/1/15/1073/018 56 pilloli miksija b'rita EU/1/15/1073/019 100 x 1 pillolia miksija b'rita EU/1/15/1073/027 14 x 1 pilloli miksija b'rita
English: Briviact solution for injection/infusion can be administered as a bolus injection or as an infusion:
Maltese: Briviact soluzzjoni għall-injezzjoni jista' jingħata bħala injezzjoni bolus jew bħala infuzjoni:
English: Pharmacokinetic/pharmacodynamics relationship
Maltese: Relazzjoni farmakokinetika/farmakodinamika
English: The 10 ml oral syringe has only one graduation in steps of 0.25 ml.
Maltese: Is-siringa ta' dożaġġ orali ta' 10 mL għandha biss gradazzjoni waħda f'passi ta' 0.25 mL.
English: There is insufficient data to determine the clinical significance of this effect in pregnancy.
Maltese: M'hemmx dejta sufficjenti sabiex tiddetermina is-sinifikanza klinika ta' dan l-effett fuq it-tqala.
English: In the clinical studies, although the numbers were limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently.
Maltese: F'studji kliniċi, għalkemm in-numri kienu limitati, ma kienx hemm ebda benefiċċju osservat ta' brivaracetam versus plaċebo f'pazjenti li jieħdu levetiracetam flimkien.
English: As from the 0.1 ml graduation mark, each graduation corresponds to 0.1 ml which is 1 mg of brivaracetam.
Maltese: Mill-marka ta' gradazzjoni ta' 0.1 mL, kull gradazzjoni tikkorrispondi għal 0.1 mL li huwa 1 mg ta' brivaracetam.
English: UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 395
Maltese: UCB Pharma S.A. Tél: + 33 / (0)1 47 29 44 35
English: What Briviact is
Maltese: DATA TA' SKADENZA
English: EU/1/15/1073/004 168 (3 packs of 56) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1073/004 168 (3 pakketti ta' 56) pilloli miksija b'rita
English: There is limited clinical experience with brivaracetam overdose in humans.
Maltese: Hemm esperjenza klinika limitata b'doża eċċessiva ta' brivaracetam fil-bniedem.
English: Overall, brivaracetam was efficacious for the adjunctive treatment of partial onset seizures in patients 16 years of age and older between 50 mg/day and 200 mg/day.
Maltese: Fuq kollox, brivaracetam kien effettiv bejn 50 mg/ġurnata u 200 mg/ġurnata f'terapija aġġuntiva f'aċċessjonijiet partial onset f'pazjenti ta' 16-il sena ‘fuq.
English: Instructions for use are provided in the package leaflet.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Briviact 10 mg/ml solution for injection/infusion
Maltese: IL-PRODOTT MEDIĊINALI Briviact 10 mg/ml soluzzjoni għall-injezzjoni/ infużjoni
English: Children and adolescents weighing less than 50 kg - The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day.
Maltese: Tfal u adolexxenti li jiżnu inqas minn 50 kg - Id-doża rakkomandata hija bejn 0.5 mg u 2 mg għal kull kg ta' piż tal-ġisem, darbtejn kuljum.
English: EU/1/15/1073/020 168 (3 packs of 56) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1073/020 168 (3 pakketti ta' 56) pilloli miksija b'rita
English: EU/1/15/1073/013 14 film-coated tablets EU/1/15/1073/014 56 film-coated tablets EU/1/15/1073/015 100 x 1 film-coated tablet EU/1/15/1073/026 14 x 1 film-coated tablet
Maltese: EU/1/15/1073/013 14 pilloli miksija b'rita EU/1/15/1073/014 56 pilloli miksija b'rita EU/1/15/1073/015 100 x 1 pillolia miksija b'rita EU/1/15/1073/026 14 x 1 pilloli miksija b'rita
English: Pharmacokinetics in special patient groups
Maltese: Farmakokinetika f'gruppi ta' pazjenti speċjali
English: OUTER CARTON of MULTIPACK (WITH BLUE BOX)
Maltese: MIKSIJA B'RITA) (MINGĦAJR IL-BLUE BOX)
English: These medicines are used to treat epilepsy.
Maltese: Dawn il-mediċini jintużaw fit-trattament tal-epilessija.
English: Figure 1: Proportion of patients by category of seizure response for brivaracetam and placebo over 12 weeks across all three double-blind pivotal trials
Maltese: Figura 1: Il-proporzjon ta' pazjenti bil-kategorija ta' rispons fl-aċċessjonijiet għal brivaracetam u plaċebo fuq 12-il ġimgħa mifrux fuq t-tlett-provi pivotali double-blind kollha
English: In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19.
Maltese: Studji in vitro wrew li brivaracetam jesebixxi ftit jew ftit li xejn inhibizzjoni ta' CYP450 isoforms ħlief għal CYP2C19.
English: Yellow, oval film-coated tablets with dimensions of 11.7 mm x 6.6 mm and debossed with ‘u50' on one side.
Maltese: Pilloli miksija b'rita safra, ovali, ta' dijametru ta' 11.7 mm x 6.6 mm u mnaqqxa b' ‘u50' fuq naħa waħda.
English: EU/1/15/1073/005 14 film-coated tablets EU/1/15/1073/006 56 film-coated tablets EU/1/15/1073/007 100 x 1 film-coated tablet EU/1/15/1073/024 14 x 1 film-coated tablet
Maltese: EU/1/15/1073/005 14 pilloli miksija b'rita EU/1/15/1073/006 56 pilloli miksija b'rita EU/1/15/1073/007 100 x 1 pillolia miksija b'rita EU/1/15/1073/024 14 x 1 pilloli miksija b'rita
English: - Pull the plunger down to the millilitre (ml) dose marker on the oral syringe prescribed by your doctor (figure 8).
Maltese: - Neħħi l-adepter mis-siringa orali (figura 2).
English: - Open the bottle: press the cap and turn it anti-clockwise (figure 1).
Maltese: - Iftaħ il-flixkun: agħfas it-tap u dawru kontra l-arloġġ (figura 1).
English: EU/1/15/1073/001 EU/1/15/1073/002 EU/1/15/1073/003 EU/1/15/1073/004 EU/1/15/1073/005 EU/1/15/1073/006 EU/1/15/1073/007 EU/1/15/1073/008 EU/1/15/1073/009 EU/1/15/1073/010 EU/1/15/1073/011 EU/1/15/1073/012 EU/1/15/1073/013 EU/1/15/1073/014 EU/1/15/1073/015 EU/1/15/1073/016 EU/1/15/1073/017 EU/1/15/1073/018 EU/1/15/1073/019 EU/1/15/1073/020 EU/1/15/1073/023 EU/1/15/1073/024 EU/1/15/1073/025 EU/1/15/1073/026 EU/1/15/1073/027
Maltese: EU/1/15/1073/016 EU/1/15/1073/017 EU/1/15/1073/018 EU/1/15/1073/019 EU/1/15/1073/020
English: Risk related to epilepsy and antiepileptic medicinal products in general For all anti-epileptic drugs, it has been shown that in the offspring of treated women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population.
Maltese: Għal kull mediċina ta' kontra l-epilessija, kien muri li fit-tfal ta' nisa ttrattati għal-epilessija, ilprevalenza ta' malformazzjonijet hija tnejn jew tlett darbiet akbar mir-rata ta' bejn wieħed u ieħor 3% fil-popolazzjoni in ġenerali.
English: EU/1/15/1073/009 14 film-coated tablets EU/1/15/1073/010 56 film-coated tablets EU/1/15/1073/011 100 x 1 film-coated tablet EU/1/15/1073/025 14 x 1 film-coated tablet
Maltese: EU/1/15/1073/009 14 pilloli miksija b'rita EU/1/15/1073/010 56 pilloli miksija b'rita EU/1/15/1073/011 100 x 1 pillolia miksija b'rita EU/1/15/1073/025 14 x 1 pilloli miksija b'rita
English: Since less than 10 % of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance (see section 5.2).
Maltese: Peress li inqas minn 10% ta' brivaracetam huwa mneħħi fl-awrina, emodijaliżi mhux mistennija li żżid b'mod sinifikanti l-eliminazzjoni ta' brivaracetam (ara sezzjon 5.2).
English: EU/1/15/1073/008 168 (3 packs of 56) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1073/008 168 (3 pakketti ta' 56) pilloli miksija b'rita
English: Suicidal ideation, psychotic disorder, aggression, agitation Nervous system disorders Very common Dizziness, somnolence Common
Maltese: Ħsibijiet ta' suwiċidju, mard psikotiku, aggressjoni, aġitazzjoni
English: EU/1/15/1073/001 14 film-coated tablets EU/1/15/1073/002 56 film-coated tablets EU/1/15/1073/003 100 x 1 film-coated tablet EU/1/15/1073/023 14 x 1 film-coated tablet
Maltese: EU/1/15/1073/001 14 pilloli miksija b'rita EU/1/15/1073/002 56 pilloli miksija b'rita EU/1/15/1073/003 100 x 1 pilloli miksija b'rita EU/1/15/1073/023 100 x 1 pilloli miksija b'rita
English: Strong enzyme inducing AEDs
Maltese: L'ebda induzzjoni ta'
English: - The recommended dose is from 0.5 mg to 2 mg for each kg of bodyweight, taken twice a day.
Maltese: - Id-doża rakkomandata hija minn 0.5 mg sa 2 mg għal kull kg ta' piż tal-ġisem, meħuda darbtejn kuljum.
English: From the pooled open-label safety and PK studies in adjunctive therapy, 149 children with POS have received brivaracetam, of whom 116 have been treated for ≥6 months, 107 for ≥12 months, 58 for ≥24 months, and 28 for ≥36 months.
Maltese: Mill-istudji miġbura tas-sigurtà open-label u tal-PK fuq terapija aġġuntiva, 149 tifel/tifla irċivew brivaracetam, li minnhom 116 kien ilhom jirċievu l-kura għal ≥6 xhur, 107 għal ≥12-il xahar, 58 għal ≥24 xahar, u 28 għal ≥36 xahar.
English: Children (≥4 years) and adolescents ≥50 kg Administered in 2 equally divided doses
Maltese: Tfal (≥4 snin) u adolexxenti ≥50 kg
English: Tel: + 48 22 696 99 20
Maltese: UCB Pharma Sp. z o.o. Tel: + 48 22 696 99 20
English: Children (from 4 years of age) and adolescents weighing 50 kg or more The recommended starting dose is 50mg/day.
Maltese: Tfal (minn età ta' 4 snin) u adolexxenti li jkunu jiżnu 50 kg jew aktar Id-doża tal-bidu rakkomandata hi ta' 50 mg/jum.
English: EU/1/15/1073/012 168 (3 packs of 56) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1073/012 168 (3 pakketti ta' 56) pilloli miksija b'rita
English: The estimated plasma clearance was 1.61 L/h, 2.18 L/h and 3.19 L/h for children weighing 20 kg, 30 kg and 50 kg, respectively.
Maltese: Modellar tal-farmakokinetika jindikaw li d-doża ta' 2.0 mg/kg darbtejn kuljum jipprovdu l-istess konċentrazzjoni medja fil-plażma bħall-adulti li rċievew 100 mg darbtejn kuljum. Leliminazzjoni stmata fil-plażma kienet ta' 1.61 L/siegħa, 2.18 L/ siegħa u 3.19 L/ siegħa għal tfal li jiżnu 20 kg, 30 kg u 50 kg, rispettivament.
English: EU/1/15/1073/016 168 (3 packs of 56) film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1073/016 168 (3 pakketti ta' 56) pilloli miksija b'rita
English: Intravenous administration was associated with infusion site pain in 2.8 % of the patients.
Maltese: It-teħid minn ġol-vina kien assoċjat ma' uġigħ fis-sit tal-infużjoni f' 2.8% tal-pazjenti.
English: Briviact 75 mg film-coated tablets Each film-coated tablet contains 75 mg brivaracetam.
Maltese: Briviact 75 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 75 mg brivaracetam.
English: Excipients which may cause intolerance
Maltese: Eċċipjenti li jistgħu jikkawżaw intolleranza
English: In clinical studies, a reduction in seizure frequency over placebo was higher with the dose of 100 mg/day than with 50 mg/day.
Maltese: F'studji kliniċi, tnaqqis fil-frekwenza tal-aċċessjonijiet fuq il-plaċebo kienet akbar b' doża ta' 100 mg/ġurnata milli b' 50 mg/ġurnata.
English: Although the number of subjects is limited, there was no observed benefit of brivaracetam versus placebo in patients taking levetiracetam concurrently which may reflect competition at the SV2A binding site.
Maltese: Għalkemm in-numru ta' pazjenti kien limitat, ma kien hemm ebda benefiċċju osservat ta' brivaracetam versus plaċebo f' pazjenti li jieħduh flimkien ma' levetiracetam li jistaċ jkun jirrifletti kompetizzjoni fisit tal-irbit-fis-SV2A .
English: For a dose of 4 mg/kg/day
Maltese: Għal doża ta' 4 mg/kg/jum
English: Exposure to brivaracetam was increased in adult patients with chronic liver disease.
Maltese: Esponiment għal brivaracetam kienet ogħla f'pazjenti adulti b'mard kroniku tal-fwied.
English: Each film-coated tablet contains 75 mg brivaracetam.
Maltese: Kull pillola miksija b'rita fiha 75 mg brivaracetam.
English: Experience with epilepsy medicines suggests that the results of efficacy studies performed in adults can be extrapolated to children down to the age of 4 years provided the paediatric dose adaptations are established and safety has been demonstrated (see sections 5.2 and 4.8).
Maltese: Esperjenza b'mediċini tal-epilessija tissuġġerixxi li r-riżultati ta' studji tal-effikaċja li twettqu f'adulti jistgħu jiġu estrapolati għal tfal sa età minima ta' 4 snin sakemm jiġu stabbiliti l-adattamenti tad-doża pedjatrika u tintwera s-sigurtà (ara sezzjonijiet 5.2 u 4.8).
English: From a microbiological point of view, the product should be used immediately after dilution.
Maltese: Minn punt mikrobijoloġiku, dan il-prodott għandu jintuza immedjatament wara d-dilwazzjoni.
English: Hepatic impairment
Maltese: Mard psikjatriku
English: Due to its lipophylicity (Log P) brivaracetam has high cell membrane permeability.
Maltese: L-effikaċja ta' brivaracetam f'monoterapija ma ġietx stabbilita.
English: In children and adolescents weighing less than 50 kg, a 1 mg/kg/day starting dose is recommended.
Maltese: Fi tfal u adolexxenti li jiżnu inqas minn 50 kg, doża tal-bidu ta' 1 mg/kg/jum hija rakkomandata.
English: Following dilution, brivaracetam solution for injection/infusion was found to be physically compatible and chemically stable when mixed with the diluents listed in the section 6.6 for 24 hours and stored in PVC or polyolefin bags at temperature up to 25°C.
Maltese: Wara i-dilwazzjoni, is-soluzzjoni brivaracetam kienet misjuba li hija fiżikament kompatibbli u kimikament stabbli meta mħallta ma' dilwenti u sustanzi oħra elenkati f'sezzjoni 6.6 għal mhux aktar minn 24 siegħa u maħżuna f' PVC jew boroż ta' polyolefin f'temperatura sa mhux aktar minn 25°C.
English: 100 mg/day
Maltese: 100 mg/ġur nata
English: Lifepharma (Z.A.M.)
Maltese: Sturdament, nagħas
English: In the table below, adverse reactions, which were identified based on review of the three placebocontrolled, fixed-dose studies safety database in subjects ≥ 16 years of age, are listed by System Organ Class and frequency.
Maltese: Fit-tabella hawn taħt, ir-reazzjonijiet avversi, li kienu identifikati fuq bażi ta' eżami tad-database tattliet studji ta' sigurta` ikkontrollati bil-plaċebo u b'doża fissa f'individwi ta' ≥ 16-il sena huma elenkati skont is-Sistema tal-Klassifikazzjoni tal-Organi u l-frekwenza.
English: Briviact 10 mg/ml injection/infusion brivaracetam
Maltese: Informazzjoni għall-pazjent Briviact 10mg/ml soluzzjoni għall-injezzjoni/infużjoni brivaracetam
English: For a dose of 3 mg/kg/day
Maltese: Għal doża ta' 3 mg/kg/jum
English: White to off-white, round film-coated tablets of 6.5 mm in diameter and debossed with ‘u10' on one side.
Maltese: Pilloli miksija b'rita bajda għal abjad imdennes, tondi, ta' dijametru ta' 6.5 mm u mnaqqxa b' ‘u10' fuq naħa waħda.
English: Further seizure frequency reduction is obtained by increasing the dose to 100 mg/day and reaches a plateau at 200 mg/day.
Maltese: Kien hemm aktar tnaqqis filfrekwenza tal-aċċessjonijiet meta d-doża tiżdied għal 100 mg/ġurnata u tilħaq pjanura b' 200 mg/ġurnata.
English: As in adults, brivaracetam solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible.
Maltese: Bħal fl-adulti, soluzzjoni għall-injezzjoni/infużjoni ta' brivaracetam hija alternattiva ta' mnejn jista jingħata għal pazjenti fejn l-għoti orali temporanjament mhuwiex fattibbli.
English: In adults, a 50 mg/day starting dose should be considered.
Maltese: F'adulti, għandha tiġi kkunsidrata doża tal-bidu ta' 50 mg/ġurnata.
English: - The active substance is clopidogrel.
Maltese: - Is-sustanza attiva hija clopidogrel.
English: Date of first authorisation: 28 July 2009 Date of latest renewal: 11 April 2014
Maltese: Data ta' l-ewwel awtorizzazzjoni: 28 ta' Lulju 2009 Data tal-aħħar tiġdid: 11ta' April 2014
English: Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Maltese: Clopidogrel u l-metabolita prinċipali (inattiv) ċirkolanti jintrabtu b'mod reversibbli in vitro malproteini umani tal-plażma (98% u 94% rispettivament).
English: Musculo-skeletal bleeding (haemarthrosis), arthritis, arthralgia, myalgia
Maltese: Fsada muskoluskeletriku (emartru), artrite, artralġija, mijalġija