FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare side effects are:
Maltese: Effetti sekondarji rari huma:
English: Common side effects are:
Maltese: Effetti sekondarji komuni huma:
English: Exalief must be added to existing anticonvulsant therapy.
Maltese: Exalief jeħtieġ jiżdied ma' terapija antikonvulżiva eżistenti.
English: HOW TO TAKE EXALIEF
Maltese: X'fih Exalief
English: In vitro eslicarbazepine is a weak inducer of CYP3A4 and UDP-glucuronyl transferases.
Maltese: In vitro eslicarbazepine huwa induttur dgħajjef ta' CYP3A4 u transferażi ta' UDPglucuronyl.
English: Memory impairment, balance disorder, amnesia, hypersomnia, sedation, aphasia, dysaesthesia, dystonia, lethargy, parosmia, autonomic nervous system imbalance, cerebellar ataxia, cerebellar syndrome, grand mal convulsion, neuropathy peripheral, sleep phase rhythm disturbance, nystagmus, speech disorder, dysarthria, hypoaesthesia, ageusia, burning sensation
Maltese: Indeboliment tal-memorja, disturb tal-bilanċ, amneżija, ipersomnija, sedazzjoni, afażja, diżestiżija, distonija, letarġija, parożmija, żbilanċ tas-sistema nervuża awtonomika, atassja ċerebellari, sindrome ċerebellari, aċċessjoni grand mal, newropatija periferali, disturb tar-rittmu tal-fażi tal-irqad, nistagmus, disturbi fid-diskors, diżartrija, ipoestiżija, agwiżija, sensazzjoni ta' ħruq
English: INFORMATION IN BRAILLE Exalief 400 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Exalief 400 mg
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 effettwat f'pazjenti anzjani b'rata ta' eliminazzjoni ta' kreatinin >60 ml/min (ara sezzjoni 4.2).
English: INFORMATION IN BRAILLE Exalief 600 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Exalief 600 mg
English: Marketing Authorisation Holder and Manufacturer BIAL - Portela & Cª , S.A., 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 , S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Il-Portugall tel: +351 22 986 61 00 fax:
English: Asthenia, malaise, chills, oedema peripheral, adverse drug reaction, peripheral coldness
Maltese: Astenija, malaise, tertir, edima periferali, reazzjoni avversa tal-mediċina, kesħa periferali
English: Nocturia, urinary tract infection
Maltese: Nokturja, infezzjoni filpassaġġ urinarju
English: INFORMATION IN BRAILLE Exalief 800 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Exalief 800 mg
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugal tel: +351 22 986 61 00 fax: +351 22 986 61 99
Maltese: Mamede do Coronado - Il-Portugall tel: +351 22 986 61 00 fax:
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 1200 mg darba kuljum ma' warfarin wera tnaqqis żgħir (23%) iżda statistikament sinifikattiv fl-esponiment għal S-warfarin.
English: EU/1/09/520/007 30 tablets - ALU/ALU blister EU/1/09/520/008 60 tablets - ALU/ALU blister EU/1/09/520/009 30 tablets - PVC/ALU blister EU/1/09/520/010 60 tablets - PVC/ALU blister
Maltese: EU/1/09/520/005 14-il pillola - PVC/ALU folji EU/1/09/520/006 28 pillola - PVC/ALU folji
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 ethinyloestradiol, respectively, most likely caused by an induction of CYP3A4.
Maltese: L-għoti ta' eslicarbazepine acetate 1200 mg darba kuljum lil suġġetti nisa li jkunu qed jużaw kontraċettiv orali ikkumbinat wera tnaqqis medju ta' 37% u 42% fl-esponiment sistemiku għal levonorgestrel u ethinyloestradiol, rispettivament, x'aktarx ikkaġunati minn induzzjoni ta' CYP3A4.
English: Exalief may make hormonal contraceptives such as the contraceptive pill less effective.
Maltese: Exalief jista' jagħmel kontraċettivi ormonali bħal pillola kontraċettiva inqas effettiva.
English: However, they have been reported with oxcarbazepine.
Maltese: Madankollu, ġew irrapportati b'oxcarbazepine.
English: EU/1/09/520/001 7 tablets - ALU/ALU blister EU/1/09/520/002 14 tablets - ALU/ALU blister EU/1/09/520/003 28 tablets - ALU/ALU blister EU/1/09/520/004 7 tablets - PVC/ALU blister EU/1/09/520/005 14 tablets - PVC/ALU blister EU/1/09/520/006 28 tablets - PVC/ALU blister
Maltese: EU/1/09/520/001 7 pilloli - ALU/ALU folji EU/1/09/520/002 14-il pillola - ALU/ALU folji
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 b'suġġetti b'saħħithom, l-għoti fl-istess ħin ta' eslicarbazepine acetate 1200 mg darba kuljum u phenytoin irriżulta fi tnaqqis medju ta' 31-33% fl-espożizzjoni tal-metabolit attiv, eslicarbazepine, li wisq probabbli jiġi kkawżat minn induzzjoni ta' glukuronidazzjoni, u żieda medja ta' 31-35% fl-espożizzjoni ta' phenytoin, wisq probabbli ikkawżata minn inibizzjoni ta' CYP2C19.
English: Exalief 400 mg tablets are packaged in ALU/ALU or ALU/PVC blisters placed into cardboard boxes containing 7, 14 or 28 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Pilloli Exalief 400 mg huma ppakkjati f'folji ALU/ALU jew ALU/PVC impoġġijin f'kaxex tal-kartun li fihom 7, 14 jew 28 pillola.
English: Eslicarbazepine has inhibiting properties with respect to CYP2C19.
Maltese: phenytoin, wisq probabbli ikkawżata minn inibizzjoni ta' CYP2C19.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 20, 30, 60 or 90 tablets
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa ta' 20, 30, 60 jew 90 pillola
English: Peak plasma concentrations (Cmax) of eslicarbazepine are attained at 2-3 hours post-dose and steady state plasma concentrations are attained after 4 to 5 days of once daily dosing, consistent with an effective half-life in the order of 20-24 h. In studies in healthy subjects and epileptic adult patients, the apparent half-life of eslicarbazepine was 10-20 h and 13-20 h, respectively.
Maltese: Konċentrazzjonijiet tal-quċċata fil-plażma (Cmax) ta' eslicarbazepine jinkisbu sagħtejn sa 3 sigħat wara d-doża u konċentrazzjonijiet fil-plażma ta' stat fiss jinkisbu 4 sa 5 ijiem ta' iddożar ta' darba kuljum, konsistenti ma' half-life effettiva ta' madwar 20-24 siegħa.
English: Increased appetite, decreased appetite, hyponatraemia, electrolyte imbalance, cachexia, dehydration, obesity
Maltese: Żieda fl-aptit, tnaqqis fl-aptit, iponatremija, żbilanċ tal-elettroliti, kakeksja, deidratazzjoni, obeżità
English: The influence of Exalief on primary generalised seizures has not been studied.
Maltese: L-influwenza ta' Exalief fuq aċċessjonijiet ġeneralizzati primarji ma ġietx studjata.
English: Exalief 400 mg tablets are white, circular and biconvex.
Maltese: Pilloli Exalief 400 mg huma bojod, tondi u konvessi miż-żewġ naħat.
English: Exalief 800 mg tablets are packed in ALU/ALU or ALU/PVC blisters placed into cardboard boxes containing 20, 30, 60 or 90 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Pilloli Exalief 800 mg huma ppakkjati f'folji ALU/ALU jew ALU/PVC impoġġijin f'kaxex tal-kartun li fihom 20, 30, 60 jew 90 pillola
English: INFORMATION IN BRAILLE Exalief 600 mg (outer pack only)
Maltese: INFORMAZZJONI BIL-BRAILLE Exalief 600 mg (pakkett ta' barra biss)
English: Eslicarbazepine acetate 800 mg once daily and 1200 mg once daily were significantly more effective than placebo in reducing seizure frequency over a 12-week maintenance period.
Maltese: Eslicarbazepine acetate 800 mg darba kuljum u 1200 mg darba kuljum kienu ferm iktar effettivi minn plaċebo fit-tnaqqis tal-frekwenza tal-aċċessjonijiet fuq perijodu ta' manteniment ta' 12-il ġimgħa.
English: INFORMATION IN BRAILLE Exalief 800 mg (outer pack only)
Maltese: INFORMAZZJONI BIL-BRAILLE Exalief 800 mg (pakkett ta' barra biss)
English: Dyspepsia, gastritis, abdominal pain, dry mouth, abdominal discomfort, abdominal distension, duodenitis, epigastric discomfort, gingival hyperplasia, gingivitis , irritable bowel syndrome, melaena, odynophagia, stomach discomfort, stomatitis, toothache
Maltese: Dispepsija, gastrite, uġigħ addominali, ħalq xott, skumdità addominali, nefħa addominali, duwodenite, skumdità epigastriku, iperplażija ġinġivali, ġinġivite, sindrome ta' musrana irritabbli, melina, odinofaġija, skumdità fl-istonku, stomatite, uġigħ tas-snien
English: NAME OF THE MEDICINAL PRODUCT Exalief 800 mg tablets
Maltese: Exalief 800 mg pilloli
English: Rash developed as an adverse reaction in 1.1% of total population treated with Exalief in placebo-controlled add-on studies in epileptic patients.
Maltese: Bħala reazzjoni avversa żviluppa raxx f'1.1% mill-popolazzjoni totali kkurata b'Exalief fi studji add-on ikkontrollati bi plaċebo f'pazjenti epilettiċi.
English: Caution should be exercised in the treatment of patients with renal impairment and the dose should be adjusted according to creatinine clearance (CLCR) as follows: - CLCR >60 ml/min: no dose adjustment required - CLCR 30-60 ml/min: initial dose of 400 mg every other day for 2 weeks followed by a once daily dose of
Maltese: Għandha tiġi eżerċitata l-kawtela fil-kura ta' pazjenti b'indeboliment renali u d-doża għandha tiġi aġġustata skont ir-rata ta' eliminazzjoni ta' kreatinin (CLCR) kif ġej: - CLCR >60 ml/min: ma huwa meħtieġ l-ebda aġġustament tad-doża - CLCR 30-60 ml/min: doża tal-bidu ta' 400 mg darba iva u darba le għal ġimagħtejn segwiti minn doża waħda kuljum ta' 400 mg.
English: NAME OF THE MEDICINAL PRODUCT Exalief 400 mg tablets
Maltese: Exalief 400 mg pilloli
English: Rash
Maltese: Sess
English: Do not take Exalief if:
Maltese: Tiħux Exalief jekk inti:
English: The pharmacokinetics of eslicarbazepine is linear and dose-proportional in the range 400-1200 mg both in healthy subjects and patients.
Maltese: Il-farmakokinetika ta' eslicarbazepine hija lineari u proporzjonali għad-doża fil-medda 400-1200 mg kemm f'suġġetti f'saħħithom kif ukoll f'pazjenti.
English: Rare adverse reactions such as bone marrow depression, anaphylactic reactions, severe cutaneous reactions (e.g. Stevens-Johnson Syndrome), systemic lupus erythematosus or serious cardiac arrhythmias did not occur during the placebo-controlled studies of the epilepsy program with eslicarbazepine acetate.
Maltese: Reazzjonijiet avversi rari bħal depressjoni fil-mudullun, reazzjonijiet anafilattiċi, reazzjonijiet serji tal-ġilda (eż. Sindrome ta' Stevens-Johnson), lupus erythematosus sistemika jew arritmija kardijaka serja ma seħħewx matul studji kkontrollati bi plaċebo tal-programm tal-epilessija b'eslicarbazepine acetate.
English: Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients.
Maltese: Sensittività eċċesiva għas-sustanza attiva jew derivattivi carboxamide oħrajn (eż., carbamazepine, oxcarbazepine) jew għal xi sustanzi mhux attivi.
English: The pharmacokinetics and metabolism of eslicarbazepine acetate were evaluated in healthy subjects and moderately liver-impaired patients after multiple oral doses.
Maltese: Il-farmakokinetiċi u l-metaboliżmu ta' eslicarbazepine acetate kienu evalwati f'suġġetti f'saħħithom u f'pazjenti b'indeboliment epatiku moderat wara diversi dożi orali.
English: Eslicarbazepine acetate is extensively converted to eslicarbazepine.
Maltese: Eslicarbazepine acetate huwa konvertit b'mod estensiv f'eslicarbazepine.
English: NAME OF THE MEDICINAL PRODUCT Exalief 600 mg tablets
Maltese: Exalief 600 mg pilloli
English: In total, eslicarbazepine and its glucuronide correspond to more than 90% of total metabolites excreted in urine, approximately two thirds in the unchanged form and one third as glucuronide conjugate.
Maltese: B'kollox, eslicarbazepine u l-glucuronide tiegħu jikkorrespondu għal iktar minn 90% tal-metaboliti totali eliminati fl-awrina, madwar żewġ terzi fil-forma mhux mibdula u terz bħala konġugat ta' glucuronide.
English: • Urinary tract infection
Maltese: • Infezzjoni fil-passaġġ urinarju
English: • you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval.
Maltese: • qed tieħu xi mediċina li tista' tikkawża anormalità fuq ECG (elettrokardjogramma) imsejħa intervall PR miżjud.
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic active substances in several indications.
Maltese: Idejazzjoni u mġiba suwiċidali ġew irrapportati f'pazjenti kkurati b'sustanzi attivi anti-epilettiċi f'indikazzjonijiet diversi.
English: The allele HLA-B*1502 is not associated to SJS in the Caucasian population.
Maltese: L-allel HLA-B*1502 mhuwiex assoċjat ma' SJS fil-popolazzjoni Kawkażjana.
English: In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4.
Maltese: Eslicarbazepine in vivo wera effett li jinduċi fuq il-metaboliżmu ta' prodotti mediċinali li primarjament jiġu eliminati minn metaboliżmu permezz ta' CYP3A4.
English: The frequency of possible side effects listed below is defined as using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000)
Maltese: Il-frekwenza ta' effetti sekondarji possibbli elenkati hawn taħt huwa definit permezz tal-konvenzjoni li ġejja: komuni ħafna (jaffettwa aktar minn utent 1 minn kull 10) komuni (jaffettwa utent 1 sa 10 minn kull 100) mhux komuni (jaffettwa utent 1 sa 10 minn kull 1,000) rari (jaffettwa utent 1 sa 10 minn kull 10,000) rari ħafna (jaffettwa inqas minn utent 1 minn kull 10,000)
English: Eslicarbazepine acetate metabolites are eliminated from the systemic circulation primarily by renal excretion.
Maltese: Metaboliti ta' eslicarbazepine acetate huma eliminati miċ-ċirkolazzjoni sistemika primarjament permezz ta' eliminazzjoni renali.
English: The safety and efficacy of Exalief in children below 18 years has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Exalief fi tfal li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: Exalief 600 mg tablets are packed in ALU/ALU or ALU/PVC blisters placed into cardboard boxes containing 30 or 60 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Pilloli Exalief 600 mg jinsabu f'pakketti f'folji ALU/ALU jew ALU/PVC impoġġijin f'kaxex tal-kartun li fihom 30 jew 60 pillola.
English: Adverse affects observed in animal studies occurred at exposure levels appreciably lower than the clinical exposure levels to eslicarbazepine (the principal and pharmacologically active metabolite of eslicarbazepine acetate).
Maltese: Effetti avversi osservati fi studji fuq l-annimali seħħew f'livelli ta' espożizzjoni ferm iktar baxxi mil-livelli ta' espożizzjoni klinika għal eslicarbazepine (il-metabolit prinċipali u farmakoloġikament attiv ta' eslicarbazepine acetate).
English: The presence of HLA-B*1502 allele in other ethnicities is negligible.
Maltese: Il-preżenza ta' allel ta' HLA-B*1502 f'etniċitajiet oħrajn hija negliġibbli.
English: Women of childbearing potential/contraception
Maltese: Nisa f'età fertili/kontraċezzjoni
English: Eslicarbazepine acetate metabolites can effectively be cleared by haemodialysis, if necessary (see section 5.2).
Maltese: Metaboliti ta' eslicarbazepine acetate jistgħu jitneħħew effettivament permezz ta' emodijaliżi, jekk meħtieġ (ara sezzjoni 5.2).
English: A study in healthy subjects showed an average decrease of 50% in systemic exposure to simvastatin when co-administered with eslicarbazepine acetate 800 mg once daily, most likely caused by an induction of CYP3A4.
Maltese: Studju li sar fuq persuni b'saħħithom wera tnaqqis medju ta' 50% fl-espożizzjoni sistemika għal simvastatin meta ngħata flimkien ma' eslicarbazepine acetate 800 mg darba kuljum, li x'aktarx kien ikkawżat minn induzzjoni ta' CYP3A4.
English: Therefore, women of childbearing potential must use adequate contraception during treatment with Exalief, and up to the end of the current menstruation cycle after the treatment has been discontinued (see section 4.4 and 4.6).
Maltese: Għaldaqstant, nisa ta' età li jkollhom it-tfal għandhom jużaw kontraċezzjoni adegwata waqt kura b'Exalief u sa tmiem iċ-ċiklu ta' mestrwazzjoni attwali wara li l-kura tkun twaqqfet (ara sezzjoni 4.4 u 4.6).
English: In studies with eslicarbazepine in fresh human hepatocytes a mild activation of UGT1A1 mediated glucuronidation was observed.
Maltese: Fi studji b'eslicarbazepine f'epatoċiti tal-bniedem friski, ġiet osservata attivazzjoni ħafifa ta' glukuronidazzjoni medjata mill-UGT1A1.
English: The tablets are packaged in blisters in cardboard boxes containing 20, 30, 60 or 90 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.
Maltese: Il-pilloli huma ppakkjati f'folji f'kaxxi tal-kartun li fihom 20, 30, 60 jew 90 pillola, u fi fliexken tal-HDPE b'għatu li ma jistax jinfetaħ mit-tfal f'kaxxi tal-kartun li fihom 90 pillola.
English: During treatment with Exalief dose adjustment is recommended in patients with creatinine clearance <60 ml/min (see section 4.2).
Maltese: Waqt kura b'Exalief aġġustament tad-doża huwa rakkomandat f'pazjenti b'rata ta' eliminazzjoni ta' kreatinin <60 ml/min (ara sezzjoni 4.2).
English: • Inflamed gums, mouth inflammation or toothache
Maltese: Palpitazzjonijiet, bradikardja, bradikardja tas-sinus
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/020
Maltese: FIS-SUQ EU/1/09/520/020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/011
Maltese: FIS-SUQ EU/1/09/520/011
English: A study in healthy subjects with eslicarbazepine acetate 1,200 mg once daily showed a minor average pharmacokinetic interaction (exposure of lamotrigine decreased 15%) between eslicarbazepine acetate and lamotrigine and consequently no dose adjustments are required.
Maltese: Studju f'suġġetti b'saħħithom b'eslicarbazepine acetate 1200 mg darba kuljum wera interazzjoni farmakokinetika medja minuri (espożizzjoni ta' lamotrigine naqset b'15%) bejn eslicarbazepine acetate u lamotrigine u konsegwentement ma huma meħtieġa l-ebda aġġustamenti tad-doża.
English: Eslicarbazepine acetate metabolites are eliminated from the systemic circulation primarily by renal excretion, in the unchanged and glucuronide conjugate forms.
Maltese: Metaboliti ta' eslicarbazepine acetate huma eliminati miċ-ċirkolazzjoni sistemika primarjament permezz ta' eliminazzjoni renali, fil-forom mhux mibdulin u ta' konġugat ta' glucuronide.
English: The efficacy and safety of eslicarbazepine acetate has been demonstrated in three phase III double-blind placebo-controlled studies in 1,049 adult patients with partial epilepsy refractory to treatment with one to three concomitant anti-epileptic medicinal products.
Maltese: III f'1,049 pazjent adult b'epilessija parzjali refrattarja għall-kura b'wieħed sa tliet prodotti mediċinali anti-epilettiċi konkomittanti.
English: • you are allergic (hypersensitive) to the active substance (eslicarbazepine acetate), to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients
Maltese: • allerġiku/a (tbati minn sensittività eċċessiva) għas-sustanza attiva (eslicarbazepine acetate), għal xi derivattivi carboxamide oħrajn (ngħidu aħna, carbamazepine jew oxcarbazepine, mediċini użati biex jikkuraw l-epilessija) jew għal xi sustanzi oħrajn
English: • you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels
Maltese: • inti ssofri minn konfużjoni, aggravar ta' puplesiji jew tnaqqis fil-konoxxenza li jistgħu jkunu sinjali ta' livelli baxxi ta' melħ fid-demm
English: Each tablet contains 600 mg of eslicarbazepine acetate.
Maltese: Exalief 600 mg pilloli Eslicarbazepine acetate
English: In vitro studies have shown that plasma protein binding was not relevantly affected by the presence of warfarin, diazepam, digoxin, phenytoin and tolbutamide.
Maltese: Studji in vitro wrew li l-irbit tal-proteini tal-plażma ma kienx effettwat b'mod rilevanti mill-preżenza ta' warfarin, diazepam, digoxin, phenytoin u tolbutamide.
English: Haemodialysis removes eslicarbazepine acetate metabolites from plasma.
Maltese: L-emodijaliżi tneħħi metabolit ta' eslicarbazepine acetate mill-plażma.
English: Vision disturbance, oscillopsia, binocular eye movement disorder, ocular hyperaemia, saccadic eye movement, eye pain
Maltese: Disturbi fil-vista, oxillopsija, disturbi ta' moviment binokulari tal-għajnejn, iperemija okulari, moviment sakkadiku tal-għajnejn, uġigħ fl-għajnejn
English: Eslicarbazepine in vivo may have an inducing effect on the metabolism of medicinal products that are mainly eliminated by conjugation through the UDP glucuronyl transferases.
Maltese: Eslicarbazepine in vivo jista' jkollu effett li jinduċi fuq il-metaboliżmu ta' prodotti mediċinali li primarjament jiġu eliminati minn konjugazzjoni permezz tal-UDP-glucuronyl transferases.
English: 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: +351 22 986 61 99 e-mail: info@bial.com
English: In humans, the pharmacological activity of eslicarbazepine acetate is primarily exerted through the active metabolite eslicarbazepine.
Maltese: Fil-bnedmin l-attività farmakoloġika ta' eslicarbazepine acetate hija primarjament eżerċitata minn ġol-metabolit attiv eslicarbazepine.
English: A meta-analysis of randomised placebo controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Maltese: Meta-analiżi ta' provi randomizzati ikkontrollati bi plaċebo ta' prodotti mediċinali anti-epilettiċi wriet ukoll żieda żgħira fir-riskju ta' ideazzjoni u mġiba suwiċidali.
English: No effects on F1 fertility parameters were observed in rats and mice.
Maltese: Ma kienu osservati l-ebda effetti fuq il-parametri F1 tal-fertilità fil-firien u fil-ġrieden.
English: Pharmacovigilance Plan or risk minimisation activities
Maltese: Sistema ta' Farmakoviġilanza jew fuq l-attivitajiet ta' minimizzazzjoni tar-riskju;
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 1,200 mg once daily and topiramate showed no significant change in exposure to eslicarbazepine but an 18% decrease in exposure to topiramate, most likely caused by a reduced bioavailability of topiramate.
Maltese: Fi studju fuq suġġetti b'saħħithom, għoti fl-istess ħin ta' eslicarbazepine acetate 1200 mg darba kuljum u topiramate ma wera ebda bidla sinifikanti fl-espożizzjoni għal eslicarbazepine iżda tnaqqis ta' 18% fl-espożizzjoni għal topiramate, wisq probabbli kkawżata minn bijodisponibilità mnaqqsa ta' topiramate.
English: HPDE bottles carton and HPDE bottles of 90 tablets
Maltese: Pakkett ta' flixken HDPE u fliexken HDPE ta' 90 pillola
English: Each tablet contains 400 mg of eslicarbazepine acetate.
Maltese: Exalief 400 mg pilloli Eslicarbazepine acetate
English: In a study in healthy subjects, concomitant administration of eslicarbazepine acetate 800 mg once daily and carbamazepine 400 mg twice daily resulted in an average decrease of 32% in exposure to the active metabolite eslicarbazepine, most likely caused by an induction of glucuronidation.
Maltese: Fi studju li sar fuq persuni b'saħħithom, l-għoti fl-istess ħin ta' eslicarbazepine acetate 800 mg darba kuljum u carbamazepine 400 mg darbtejn kuljum, irriżulta fi tnaqqis medju ta' 32% fl-espożizzjoni għall-metabolit attiv eslicarbazepine, li x'aktarx kien ikkawżat minn induzzjoni ta' glukoronidazzjoni.