FrancophonIA/ELRC3.0 huggingface dataset:
English: 7 tablets 14 tablets 28 tablets
Maltese: 7 pilloli 14-il pillola 28 pillola
English: Eslicarbazepine Cmax is attained at 2 to 3 hours post-dose (tmax).
Maltese: Eslicarbazepine Cmax jintlaħaq 2-3 sigħat wara d-doża (tmax).
English: BIAL -Portela & Cª, S.A. À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Maltese: BIAL - Portela & Cª , S.A. À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Il-Portugall
English: Date of first authorisation: 21.04.2009 Date of latest renewal: 22.01.2014
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' April, 2009 Data tal-aħħar tiġdid: 22 ta' Jannar, 2014
English: Diplopia, vision blurred
Maltese: Diplopija, vista mċajpra
English: • The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.
Maltese: • Is-sustanzi mhux attivi l-oħra huma povidone K29/32, croscarmellose sodium u magnesium stearate.
English: • Medicine toxicity;
Maltese: • Tossiċità għall-mediċina;
English: Flavour Tutti-Frutti artificial (contains maltodextrin, propylene glycol, natural and artificial flavouring, and gum acacia (E414)
Maltese: Togħma Tutti-Frutti artifiċjali (fih maltodextrin, propylene glycol, togħma naturali u artifiċjali, u gum acacia (E414)
English: The frequency of the HLA-A*3101 allele varies widely between ethnic populations.
Maltese: Il-frekwenza tal-allele HLA-A*3101 tvarja ħafna bejn popolazzjonijiet etniċi.
English: PVC/ALU blister
Maltese: PVC/ALU folji ISEM
English: The target dose was 30 mg/kg/day in study 208 and 20 mg/kg/day in study 305.
Maltese: Id-doża fil-mira kienet ta' 30 mg/kg/jum fi istudju 208 u 20 mg/kg/jum fi studju 305.
English: Zebinix is indicated as:
Maltese: Zebinix jintuża:
English: The other ingredients are xanthan gum (E415), macrogol-100 stearate, methyl parahydroxybenzoate (E218), saccharin sodium (E954), flavour tutti-frutti artificial (contains maltodextrin, propylene glycol, natural and artificial flavouring, and gum acacia (E414), masking flavour (contains propylene glycol, water and natural and artificial flavouring) and purified water.
Maltese: • Is-sustanzi mhux attivi l-oħra huma are xanthan gum (E415), macrogol-100 stearate, methyl parahydroxybenzoate (E218), saccharin sodium (E954), togħma tutti-frutti artifiċjali (fiha maltodextrin, propylene glycol, togħma naturali u artifiċjali, u gum acacia (E414), masking flavour (fih propylene glycol, ilma u togħma naturali u artifiċjali) u ilma ppurifikat.
English: Minor metabolites in plasma are Rlicarbazepine and oxcarbazepine, which were shown to be active, and the glucuronic acid conjugates of eslicarbazepine acetate, eslicarbazepine, R-licarbazepine and oxcarbazepine.
Maltese: Metaboliti minuri fil-plażma huma R-licarbazepine u oxcarbazepine, li intwera li kienu attivi, u l-konjugati ta' glucuronic acid ta' eslicarbazepine acetate, eslicarbazepine, R-licarbazepine u oxcarbazepine.
English: Take special care with Zebinix:
Maltese: Tiħux Zebinix:
English: Class related adverse reactions
Maltese: Reazzjonijiet avversi relatati mal-klassi
English: In studies in healthy subjects and epileptic adult patients, the apparent half-life of eslicarbazepine was 10-20 hours and 13-20 hours, respectively.
Maltese: Fi studji f'persuni f'saħħithom u f'pazjenti epilettiċi adulti, il-half life apparenti ta' eslicarbazepine kienet ta' 10-20 siegħa u 13-20 siegħa, rispettivament.
English: A total of 39% patients in study 305 were up titrated to the maximum possible dose (30 mg/kg/day).
Maltese: Total ta' 39% tal-pazjenti fi studju 305 ġew ittitrati 'l fuq għad-doża massima possibbli (30 mg/kg/jum).
English: Zebinix 50 mg/ml oral suspension
Maltese: Zebinix 50 mg/ml suspensjoni orali
English: • Allergy;
Maltese: • Allerġija
English: Each cardboard box contains a 10 ml polypropylene graduated syringe with 0.2 ml graduations, and a copolymer push-in bottle adapter.
Maltese: Kull kaxxa tal-kartun fiha siringa gradwata tal-polypropylene ta' 10 ml bi gradwazzjonijiet ta' 0.2 ml, u copolymer push-in bottle adapter.
English: Studies in animals have shown impairment of fertility after treatment with eslicarbazepine acetate (see section 5.3).
Maltese: Studji f'annimali urew indeboliment tal-fertilità wara t-trattament b'eslicarbazepine acetate (ara sezzjoni 5.3).
English: Aluminium / Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 20, 30, 60 or 90 tablets and in multi-packs containing 180 (2 packs of 90) tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih F'folji Aluminju/Aluminju jew PVC/Aluminju impoġġijin f'kaxex tal-kartun li fihom 20, 30, 60 jew 90 pillola u f'pakketti b'ħafna li fihom 180 (2 pakketti ta' 90) pilloli.
English: Each ml of oral suspension contains 2.0 mg of methyl parahydroxybenzoate (E218) and approximately 0.00001 mg of sulphites.
Maltese: Kull ml ta' suspensjoni orali fih mg 2.0 ta' methyl parahydroxybenzoate (E218) u madwar 0.00001 mg ta' sulphites.
English: Malaise, chills, oedema peripheral
Maltese: Telqa, tertir, edema periferali
English: Zebinix contains methyl parahydroxybenzoate (E218) and sulphites
Maltese: Fih methyl parahydroxybenzoate (E218) u sulphites
English: Eslicarbazepine acetate was tested at doses of 400 mg (in -301 and -302 studies only), 800 mg and 1,200 mg, once daily.
Maltese: Eslicarbazepine acetate kien ittestjat f'dożi ta' 400 mg (fl - 301 u -302 studji biss), 800 mg u 1,200 mg, darba kuljum.
English: The percentage of subjects with ≥50% reduction (1581 analyzed) in seizure frequency in the phase III studies was 19.3% for placebo, 20.8% for eslicarbazepine acetate 400 mg, 30.5% for eslicarbazepine acetate 800 mg and 35.3% for eslicarbazepine acetate 1,200 mg daily.
Maltese: 8% għal eslicarbazepine acetate 400 mg, 30.5% għal eslicarbazepine acetate 800 mg u 35.3% għal eslicarbazepine acetate 1,200 mg kuljum.
English: HLA-B* 1502 allele - in Han Chinese, Thai and other Asian populations
Maltese: Allele HLA-B* 1502 - f'popolazzjonijiet Ħan Ċiniżi, Tajlandiżi u popolazzjonijiet Asjatiċi oħrajn
English: Children ≥60 kg
Maltese: Tfal li jiżnu ≥60 kg
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjoni 4.8, 5.1 u 5.2 iżda ma tista' ssir lebda rakkomandazzjoni dwar pożoloġija.
English: • Attention deficit/ hyperactivity disorder;
Maltese: • Disturb ta' defiċit fl-attenzjoni/bl-iperattività • Irritabilità
English: Eisai B.V. Tél/Tel: + 31 (0) 900 575 3340
Maltese: Tél/Tel: + 31 (0) 900 575
English: (only for outer packaging)
Maltese: (pakkett ta' barra biss)
English: Zebinix may make hormonal contraceptives such as the contraceptive pill less effective.
Maltese: Zebinix jista' jagħmel kontraċettivi ormonali bħal pillola kontraċettiva, inqas effettiva.
English: Both studies were double-blind and placebo controlled with a duration of maintenance of 8 weeks (study 208) and 12 weeks (study 305), respectively.
Maltese: Iż-żewġ studji kienu double-blind u kkontrollati bi plaċebo, b'perjodu ta' tul ta' manteniment ta' 8 ġimgħat (studju 208) u 12-il Ġimgħa (studju 305), rispettivament.
English: 200 ml bottle oral syringe (10 ml) (outer pack only)
Maltese: Flixkun ta' 200 ml Siringa orali (10 ml) (pakkett ta' barra biss)
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and phenytoin resulted in an average decrease of 31-33% in exposure to the active metabolite, eslicarbazepine, most likely caused by an induction of glucuronidation, and an average increase of 31-35% in exposure to phenytoin, most likely caused by an inhibition of CYP2C19.
Maltese: Fi studju f'persuni b'saħħithom, l-għoti fl-istess ħin ta' eslicarbazepine acetate 1,200 mg darba kuljum u phenytoin irriżulta fi tnaqqis medju ta' 31-33% fl-esponiment għall-metabolit attiv, eslicarbazepine, li wisq probabbli jiġi kkawżat minn induzzjoni ta' glukuronidazzjoni, u żieda medja ta' 31-35% flesponiment għal phenytoin, wisq probabbli ikkawżat minn inibizzjoni ta' CYP2C19.
English: Dermatitis allergic (uncommon, 0.8%) was reported only in the paediatric population.
Maltese: Dermatite allerġika (mhux komuni, 0.8%) ġiet irrappurtata biss fil-popolazzjoni pedjatrika.
English: Zebinix 50 mg/ml oral suspension Eslicarbazepine acetate
Maltese: Zebinix 50 mg/ml suspensjoni orali Eslicarbazepine acetate
English: Masking flavour (contains propylene glycol, water and natural and artificial flavouring) Purified water
Maltese: Masking flavour (fih propylene glycol, ilma u togħma naturali u artifiċjali)
English: In clinical studies (adjunctive therapy treatment and monotherapy), 2,434 patients with partial-onset seizures were treated with eslicarbazepine acetate (1,983 adult patients and 451 paediatric patients) and 51% of those patients experienced adverse reactions.
Maltese: Fi studji kliniċi (kura b'terapija miżjuda u b'monoterapija), 2,434 pazjent b'aċċessjonijiet ta' bidu parzjali, ġew ikkurati b'eslicarbazepine acetate (1,983 pazjent adult u 451 pazjent pedjatriku) u 51% minn dawk il-pazjenti kellhom reazzjonijiet avversi.
English: • hormonal contraceptives (such as the contraceptive pill) since Zebinix may make these less effective;
Maltese: • kontraċettivi ormonali (bħall pillola kontraċettiva) peresse Zebinix jista 'jagħmel dawn inqas effettiv;
English: HLA-A*3101 allele has a prevalence of 2 to 5% in European populations and about 10% in Japanese population.
Maltese: L-allele HLA-A*3101 għandu prevalenza ta' 2 sa 5% fil-popolazzjonijiet Ewropej u madwar 10% fil-popolazzjoni Ġappuniża.
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) and not known (frequency cannot be estimated from 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, u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The doses of the active comparator, carbamazepine controlled release, were 200 mg, 400 mg and 600 mg, twice-daily.
Maltese: Id-dożi talkomparatur attiv, carbamazepine li jintreħa b'mod ikkontrollat, kienu 200 mg, 400 mg u 600 mg,
English: The safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients were evaluated in one non-controlled study, with a duration of 26 weeks, in 72 elderly (aged ≥ 65 years).
Maltese: Is-sigurtà u l-effikaċja ta' eslicarbazepine acetate bħala terapija aġġuntiva għal aċċessjonijiet parzjali f'pazjenti anzjani ġiet evalwata fi studju wieħed mhux ikkontrollat, li dam 26 ġimgħa, fi 72 persuna anzjana (li kellhom ≥ 65 sena).
English: Pharmacotherapeutic group: Antiepileptics, carboxamide derivatives, ATC code: N03AF04
Maltese: Mediċini antiepilettiċi, derivattivi ta' carboxamide, Kodiċi ATC:
English: In patients concomitantly treated with carbamazepine and eslicarbazepine acetate in placebocontrolled studies, the following adverse reactions were observed: diplopia (11.4% of subjects with concomitant carbamazepine, 2.4% of subjects without concomitant carbamazepine), abnormal coordination (6.7% with concomitant carbamazepine, 2.7% without concomitant carbamazepine), and dizziness (30.0% with concomitant carbamazepine, 11.5% without concomitant carbamazepine), see section 4.5.
Maltese: F'pazjenti kkurati fl-istess ħin b'carbamazepine u b'eslicarbazepine acetate fi studji kkontrollati bi plaċebo, ir-reazzjonijiet avversi li ġejjin kienu osservati: diplopja (11.4% tal-persuni li ħadu carbamazepine fl-istess ħin, 2.4% tal-persuni li ma ħadux carbamazepine fl-istess ħin), koordinazzjoni anormali (6.7% tal-persuni li ħadu carbamazepine fl-istess ħin, 2.7% tal-persuni li ma ħadux carbamazepine fl-istess ħin), u sturdament (30.0% tal-persuni li ħadu carbamazepine fl-istess ħin, 11.5% tal-persuni li ma ħadux carbamazepine fl-istess ħin), ara sezzjoni 4.5.
English: In the age group from 6 to 11 years of age, the most common adverse reactions observed in more than two patients treated with eslicarbazepine acetate were diplopia (9.5%), somnolence (7.4%), diziness (6.3%), convulsion (6.3%) and nausea (3.2%); in the age group from 12 to 18 years were somnolence (7.4%), vomiting (4.2%), diplopia (3.2%) and fatigue (3.2%).
Maltese: Fil-grupp ta' età minn 6 sa 11-il sena, l-aktar reazzjonijiet avversi komuni osservata f'aktar minn żewġ pazjenti kkurati b'eslicarbazepine acetate kienu diplopija (9.5%), ngħas (7.4%), sturdament (6.3%), konvulżjoni (6.3%) u dardir (3.2%); fil-grupp ta' età minn 12 sa 18-il sena kienu ngħas (7.4%), rimettar (4.2%), diplopija (3.2%) u għeja (3.2%).
English: Outer carton / bottle
Maltese: Kartina ta' barra/flixkun
English: From the 815 randomized patients, 401 patients were treated with eslicarbazepine acetate once-daily [271 patients (67.6%) remained at dose of 800 mg, 70 patients (17.5%) remained at dose of 1,200 mg and 60 patients (15.0%) were treated with 1,600 mg].
Maltese: Mit815 pazjent li ntgħażlu b'mod każwali, 401 pazjent ġew ikkurati b'eslicarbazepine acetate [271 pazjent (67.6%) baqgħu fuq doża ta' 800 mg, 70 pazjent (17.5%) baqgħu f'doża ta' 1,200 mg, u 60 pazjent (15.0% ) ġew ikkurati b'doża ta' 1,600 mg].
English: Risk related to epilepsy and antiepileptic medicinal products in general
Maltese: Riskju relatat ma' epilessija u ma' prodotti mediċinali għal kontra l-epilessija in ġenerali
English: The binding of warfarin, diazepam, digoxin, phenytoin and tolbutamide was not significantly affected by the presence of eslicarbazepine.
Maltese: It-twaħħil ta' warfarin, diazepam, digoxin, phenytoin u tolbutamide ma kienx sinifikattivament affettwat mill-preżenza ta' eslicarbazepine.
English: EU/1/09/514/021 20 tablets - PVC/ALU blister EU/1/09/514/022 60 tablets - PVC/ALU blister
Maltese: EU/1/09/514/021 20 pillola - PVC/ALU folji EU/1/09/514/022 60 pillola - PVC/ALU folji
English: 20 tablets 60 tablets
Maltese: 20 pillola 60 pillola
English: Electrolyte imbalance, dehydration, hypochloraemia
Maltese: Żbilanċ tal-elettroliti, deidratazzjoni, ipokloremija
English: Seizure-free rates during the entire 10-week monotherapy period were 7.6% (1,600 mg) and 8.3 % (1,200 mg) in one study and 10.0% (1,600 mg) and 7.4 % (1,200 mg) in the other study, respectively.
Maltese: 10 ġimgħat kienu ta' 7.6% (1,600 mg) u 8.3% (1,200 mg) fi studju wieħed, u 10.
English: 90 tablets.
Maltese: 28 pillola.
English: The maximum dose is1,200 mg once daily (see section 5.1).
Maltese: Id-doża massima hi ta' 1,200 mg darba kuljum (ara sezzjoni 5.1).
English: In children above 6 years, 36 patients (35.0%) in the eslicarbazepine acetate group compared to 29 patients (30.2%) in the placebo group were responders (p=0.4759) and the least square mean reduction in standardised seizure frequency was higher in the eslicarbazepine acetate group compared to placebo (-24.4% versus -10.5%); however, the difference of 13.9% was not statistically significant (p=0.1040).
Maltese: 2%) fil-grupp tal-plaċebo, irrispondew għall-kura (p = 0.4759), u t-tnaqqis medja tal-least squares fil-frekwenza standardizzata ta' aċċessjonijiet kienet ogħla fil-grupp ta' eslicarbazepine acetate meta mqabbla mal-plaċebo (-24.4% kontra -10.5%); madankollu, id-differenza ta' 13.9% ma kinitx statistikament sinifikanti (p=0.1040).
English: The pharmacokinetic profile of eslicarbazepine acetate is unaffected in the elderly patients with creatinine clearance >60 ml/min (see section 4.2).
Maltese: Il-profil farmakokinetiku ta' eslicarbazepine acetate mhuwiex affettwat f'pazjenti anzjani b'rata ta' eliminazzjoni ta' krejatinina ta' >60 ml/min (ara sezzjoni 4.2).
English: However, they have been reported with oxcarbazepine.
Maltese: Madankollu, ġew irrappurtati b'oxcarbazepine.
English: Other medicinal products
Maltese: FARMAĊEWTIKA
English: Symptoms observed after an overdose of eslicarbazepine acetate are primarily associated with central nervous symptoms (e.g. seizures of all types, status epilepticus) and cardiac disorders (e.g. cardiac arrhythmia).
Maltese: Is-sintomi osservati wara doża eċċessiva ta' eslicarbazepine acetate huma primarjament assoċjati massistema nervuża ċentrali (eż. aċċessjonijiet ta' kull tip, status epilepticus) u disturbi kardijaċi (eż. arritmija kardijaka).
English: The data shows that the incidence of adverse reactions in this population (65.3 %) is similar to the general population enrolled in the double-blind epilepsy studies (66.8%).
Maltese: Id-dejta turi li l-inċidenza ta' reazzjonijiet avversi f'din il-popolazzjoni (65.3%) hi simili bħal dik tal-popolazzjoni ġenerali li ġiet irreġistrata fl-istudji double-blind dwar l epilessija (66.8%).
English: Amongst these, when excluding patients aged 6 years and younger, 14 (48.3%) and 11 (30.6%) of patients in the eslicarbazepine acetate and placebo group, respectively, were responders (p=0.1514).
Maltese: Fost dawn, meta wieħed jeskludi pazjenti li kellhom 6 snin u iżgħar, 14 (48.3%) u 11 (30.6%) tal-pazjenti fil-grupp ta' eslicarbazepine acetate u fil grupp tal-plaċebo, rispettivament, irrispondew għall-kura (p = 0.1514).
English: Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċesiva għas-sustanza attiva jew derivattivi carboxamide oħrajn (eż., carbamazepine, oxcarbazepine) jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Administration of eslicarbazepine acetate 1,200 mg once daily to female subjects using a combined oral contraceptive showed an average decrease of 37% and 42% in systemic exposure to levonorgestrel and ethinylestradiol, respectively, most likely caused by an induction of CYP3A4.
Maltese: L-għoti ta' eslicarbazepine acetate 1,200 mg darba kuljum lil persuni nisa li jkunu qed jużaw kontraċettiv orali ikkombinat wera tnaqqis medju ta' 37% u 42% fl-esponiment sistemiku għal levonorgestrel u ethinyloestradiol, rispettivament, x'aktarx ikkaġunat minn induzzjoni ta' CYP3A4.
English: The most frequent individual adverse reactions were dizziness (12.5% of subjects), somnolence (9.7%), fatigue, convulsion and hyponatraemia (8.3%, each), nasopharyngitis (6.9%) and upper respiratory tract infection (5.6%).
Maltese: L-iktar reazzjonijiet avversi individwali frekwenti kienu sturdament (12.5%) tal individwi, ngħas (9.7%), għeja kbira, konvulżjoni u iponatremija (8.3% kull wieħed), nażofarinġite (6.9%) u infezzjoni fin-naħa ta' fuq tal-passaġġ respiratorju (5.6%).
English: The total median standardised seizure frequency was 2.4 (resulting in a median relative change from Baseline Part III-V of -22.9%).
Maltese: Il frekwenza medjana totali ta' aċċessjonijiet standardizzati kienet ta' 2.4 (li rriżultat f'bidla relattiva medjana mill-Partijiet fil-Linja Bażi III-V ta' -22.9%).
English: • Difficulty in coordinating movements (ataxia);
Maltese: • Diffikultà biex tikkordina l-movimenti (atassja);
English: zebinix 50 mg/ml (outer pack only)
Maltese: zebinix 50 mg/ml (pakkett ta' barra biss)
English: 30 tablets 60 tablets
Maltese: 30 pillola 60 pillola
English: The prevalence of HLA-B*1502 carrier is about 10% in Han Chinese and Thai populations.
Maltese: Il-prevalenza ta' persuna li ġġorr HLA-B*1502 hi ta' madwar 10% f'popolazzjonijiet Ħan Ċiniżi u Tajlandiżi.
English: Of the 183 patients who completed parts I and II of the study, 152 patients were enrolled into part III.
Maltese: Mill-183 pazjent li lestew partijiet I u II tal-istudju, 152 pazjent kienu rreġistrati fil-parti
English: Zebinix oral suspension contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed) and sulphites which may rarely cause severe hypersensitivity reactions and bronchospasm.
Maltese: Zebinix suspensjoni orali fih methyl parahydroxybenzoate (E218) li jistgħu jikkawżaw reazzjonijiet allerġiċi (possibbilment li jdumu ma jseħħu) u sulphites li jistgħu rarament jikkawżaw reazzjonijiet ta'
English: Teл.
Maltese: Mejt
English: In vitro eslicarbazepine is a weak inducer of CYP3A4 and UDP-glucuronyl transferases.
Maltese: In vitro, eslicarbazepine huwa induttur dgħajjef ta' CYP3A4 u ta' UDP
English: Two clusters of ADRs were identified in context of overdose cases - epilepsy/seizures/status epilepticus and cardiac events, mainly arrhythmias.
Maltese: Żewġ raggruppamenti ta' ADRs (Adverse Drug Reactions - Reazzjonijiet Avversi għall-Mediċina) kienu identifikati filkuntest ta' każijiet ta' doża eċċessiva - epilessija/aċċessjonijiet/status epilepticus u avvenimenti kardijaċi, l-aktar arritmija.
English: Dizziness; somnolence; vertigo; asthenia; gait disturbance; tremor; ataxia; balance disorder; vision blurred; diarrhoea; rash and hyponatraemia were less common in children than in adults.
Maltese: Sturdament; ngħas; mejt; astenija; disturb fil-mixi; rogħda; atassija; disturb fil-bilanċ; vista mċajpra; dijarea; raxx u iponatremija, kienu inqas komuni fit-tfal milli fl-adulti.
English: Τηλ: + 30 210 668 3000
Maltese: Arriani Pharmaceuticals S.A. Τηλ: + 30 210 668 3000
English: Uncommon Not known
Maltese: Komuni ħafna
English: In the subsequent 1-year open-label extension (Part II) of the phase III study (ITT set N=225) the total responder rate was 46.7% (steadily increasing from 44.9% (weeks 1-4) to 57.5% (weeks > 40)).
Maltese: III (sett ITT N = 225) ir-rata ta' dawk li rrispondew totali kienet ta' 46.7% (li żdiedet b'mod stabbli minn 44.9% (ġimgħat 1-4) għal 57.5% (ġimgħat > 40)).
English: There are insufficient data supporting a recommendation for HLA-A*3101 screening before starting carbamazepine or chemically-related compounds treatment.
Maltese: Hemm dejta insuffiċjenti li tappoġġja rakkomandazzjoni għal screening ta' HLA-A*3101 qabel tinbeda kura b'carbamazepine jew b'komposti kimikament relatati.
English: The most common adverse reaction in the group treated with eslicarbazepine acetate were diplopia (5.0%), somnolence (8.0%) and vomiting (4.6%).
Maltese: L-aktar reazzjonijiet avversi komuni fil grupp ikkurat b'eslicarbazepine acetate kienu diplopija (5.0%), ngħas (8.0%) u rimettar (4.6%).
English: EU/1/09/514/001 7 tablets - ALU/ALU blister EU/1/09/514/002 14 tablets - ALU/ALU blister EU/1/09/514/003 28 tablets - ALU/ALU blister EU/1/09/514/004 7 tablets - PVC/ALU blister EU/1/09/514/005 14 tablets - PVC/ALU blister EU/1/09/514/006 28 tablets - PVC/ALU blister
Maltese: EU/1/09/514/001 7 pilloli - ALU/ALU folji EU/1/09/514/002 14-il pillola - ALU/ALU folji EU/1/09/514/003 28 pillola - ALU/ALU folji EU/1/09/514/004 7 pilloli - PVC/ALU folji EU/1/09/514/005 14-il pillola - PVC/ALU folji EU/1/09/514/006 28 pillola - PVC/ALU folji
English: The pharmacokinetics and metabolism of eslicarbazepine acetate were evaluated in healthy subjects and moderately liver-impaired patients after multiple oral doses.
Maltese: Il-farmakokinetika u l-metaboliżmu ta' eslicarbazepine acetate kienu evalwati f'persuni f'saħħithom u f'pazjenti b'indeboliment epatiku moderat wara dożi orali multipli.
English: BIAL - Portela & Cª , SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99 e-mail: info@bial.com
Maltese: BIAL - Portela & Cª , SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Il-Portugall tel: +351 22 986 61 00 fax:
English: Eslicarbazepine acetate was tested at doses of 20 and 30 mg/kg/day, up to a maximum of 1,200 mg/day.
Maltese: Eslicarbazepine acetate ġie ttestjat f'dożi ta' 20 u 30 mg/kg/jum, sa massimu ta' 1,200 mg/jum.
English: Epistaxis, chest pain
Maltese: Epistassi, uġigħ fis sider
English: Co-administration of eslicarbazepine acetate 1,200 mg once daily with warfarin showed a small (23%), but statistically significant decrease in exposure to S-warfarin.
Maltese: Għoti konkomitanti ta' eslicarbazepine acetate 1,200 mg darba kuljum ma' warfarin wera tnaqqis żgħir (23%) iżda statistikament sinifikattiv fl-esponiment għal S-warfarin.
English: HLA-A*3101 allele- European descent and Japanese populations
Maltese: L-allele HLA-A*3101