FrancophonIA/ELRC3.0 huggingface dataset:
English: There was an average decrease of 36-39% in systemic exposure in healthy subjects when co-administered with eslicarbazepine acetate 1,200 mg once daily.
Maltese: Kien hemm tnaqqis medju ta' 36-39% fl-esponiment sistemiku f'individwi b'saħħithom meta jingħata flimkien ma' eslicarbazepine acetate 1,200 mg darba kuljum.
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: Dizziness, somnolence
Maltese: afażija, diżestiżija,
English: • Burning sensation;
Maltese: sensazzjoni ta'
English: Thus, interactions can arise when co-administering high doses of eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19 (e.g. Phenytoin).
Maltese: Għaldaqstant, jista' jkun hemm interazzjonijiet meta dożi għoljin ta' eslicarbazepine acetate jingħataw fl-istess ħin ma' prodotti mediċinali li huma metabolizzati primarjament minn CYP2C19 (eż., Phenytoin).
English: • Shaking;
Maltese: • Taqa'
English: Headache, disturbance in attention, tremor, ataxia, balance disorder
Maltese: Insomnja Disturb psikotiku, apatija, dipressjoni,
English: Eslicarbazepine acetate was tested at once-daily doses of 800 mg, 1,200 mg and 1,600 mg.
Maltese: Eslicarbazepine acetate ġie ttestjat f'dożi ta' darba kuljum ta' 800 mg, 1,200 mg u 1,600 mg.
English: Population pharmacokinetics indicate that comparable eslicarbazepine exposure is observed between 20 and 30 mg/kg/day in children above 6 years old and adults with 800 and 1200 mg of eslicarbazepine acetate once-daily, respectively (see section 4.2).
Maltese: Il-farmakokinetika tal-popolazzjoni tindika li esponiment komparabbli ta' eslicarbazepine jiġi osservat f'doża ta' bejn 20 u 30 mg/kg/jum fi tfal li jkollhom aktar minn 6 snin u f'adulti f'doża bejn 800 u
English: 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: The overall median relative decrease in Part I was greater in patients treated with ESL (-25.8%) than in patients treated with placebo (-16.4%).
Maltese: It-tnaqqis relattiv medjan globali f'Parti I kien akbar fil-pazjenti ttrattati b'ESL (-25.8%) milli fil-pazjenti ttrattati bil-plaċebo (-16.4%).
English: Zebinix 800 mg tablets Eslicarbazepine acetate
Maltese: Zebinix 800 mg pilloli Eslicarbazepine acetate
English: The maximum is 1,200 mg once daily.
Maltese: 1,200 mg/jum.
English: The safety profile of eslicarbazepine acetate was generally similar between adult and paediatric patients, except for agitation (common, 1.3%) and abdominal pain (common, 2.1%) which were more common in children than in adults.
Maltese: Il-profil tas-sigurtà ta' eslicarbazepine acetate ġeneralment kien simili bejn pazjenti adulti u pedjatriċi, ħlief għal aġitazzjoni (komuni, 1.3%) u wġigħ addominali (komuni, 2.1%), li kienu aktar komuni fit-tfal milli fl-adulti.
English: The efficacy of eslicarbazepine acetate as adjunctive therapy has been demonstrated in four phase III double-blind placebo-controlled studies in 1,703 randomized adult patients with partial epilepsy refractory to treatment with one to three concomitant antiepileptic medicinal products.
Maltese: III double blind ikkontrollati bi plaċebo f'1,703 ntgħażlu b'mod każwali pazjent adult b'epilessija parzjali refrattarja għall-kura b'wieħed sa tliet prodotti mediċinali antiepilettiċi konkomitanti.
English: There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with the structurally related antiepileptic drugs carbamazepine and oxcarbazepine.
Maltese: Kien hemm ukoll rapporti ta' tnaqqis fid-densità tal-minerali tal-għadam, osteopenija, osteporożi u ksur tal-għadam f'pazjenti fuq terapija fit-tul bil-mediċini antiepilettiċi strutturalment relatati carbamazepine u oxcarbazepine.
English: There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures with structurally related antiepileptics medicines like carbamazepine and oxcarbazepine.
Maltese: Kien hemm rapporti ta' disturbi fl-għadam inkluż osteopenija u osteoporożi (l-għadam jirqaq) u ksur tal-għadam b'mediċini antiepilettiċi strutturalment relatati bħal carbamazepine u oxcarbazepine.
English: Zebinix 400 mg tablets are white, circular and biconvex.
Maltese: Pilloli Zebinix 400 mg huma bojod, tondi u konvessi miż-żewġ naħat.
English: There are some data that suggest HLA-A*3101 is associated with an increased risk of carbamazepine induced cutaneous adverse drug reactions including SJS, TEN, Drug rash with eosinophilia (DRESS), or less severe acute generalized exanthematous pustulosis (AGEP) and maculopapular rash in people of European descent and the Japanese.
Maltese: Hemm xi dejta li tissuġġerixxi li HLA-A*3101 hu assoċjat ma' żieda fir-riskju ta' reazzjonijiet avversi tal-mediċina fil-ġilda kkaġunati minn carbamazepine li jinkludu s-Sindrome ta' Stevens-Johnson (SJS), Nekrolisi epidermali tossika (TEN), Raxx minħabba l-mediċina b'eosinofilija (DRESS), jew pustulożi exanthematous ġeneralizzata akuta inqas severa (AGEP) u raxx makulopapulari bl-infafet f'nies ta' razza Ewropea u nies Ġappuniżi.
English: White circular biconvex tablets, engraved ‘ESL 400'on one side and scored on the other side, with a diameter of 11 mm..
Maltese: Pilloli bojod tondi bikonvessi, imnaqqxin b'‘ESL 400' fuq naħa waħda u mnaqqxin b'sinjal fuq in-naħa l-oħra, b'dijametru ta' 11 mm.
English: In the primary efficacy analysis, in which drop-outs were considered as non-responders, 71.1% subjects were classified as seizure free in the eslicarbazepine acetate group and 75.6% in the carbamazepine controlled release group during the 26 week evaluation period (average risk difference -4.28%, 95% confidence interval: [-10,30; 1,74].
Maltese: Fl-analiżi primarja tal-effikaċja, li fiha dawk li ma baqgħux fl-istudju ġew kkunsidrati bħala li ma rrispondewx, 71.1% tal-individwi kienu kklassifikati bħala li ma kellhomx epilessija fil-grupp ta' eslicarbazepine acetate, u 75.6% fil-grupp ta' carbamazepine li jintreħa b'mod ikkontrollat, matul il-perjodu ta' evalwazzjoni ta' 26 ġimgħa (medja fid-differenza tar-riskju ta'4.28%, intervall ta' kunfidenza ta' 95%:
English: Aluminium /Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 30 or 60 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 30 jew 60 pillola.
English: PVC/Aluminium blisters placed into cardboard boxes containing 20 or 60 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih F'folji PVC/Aluminju impoġġijin f'kaxex tal-kartun li fihom 20 jew 60 pillola.
English: Eslicarbazepine acetate 800 mg once daily and 1,200 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 1,200 mg darba kuljum kienu ferm iktar effettivi minn plaċebo fit-tnaqqis tal-frekwenza tal-aċċessjonijiet fuq perijodu ta' manteniment ta' 12-il ġimgħa.
English: The chemical structure of eslicarbazepine acetate is similar to that of carbamazepine, and it is possible that patients who are positive for HLA-B*1502 may also be at risk for SJS after treatment with eslicarbazepine acetate.
Maltese: L-istruttura kimika ta' eslicarbazepine acetate hi simili għal dik ta' carbamazepine, u hu possibbli li pazjenti li huma pożittivi għal HLA-B*1502 jistgħu wkoll ikunu f'riskju għal SJS wara l-kura b'eslicarbazepine acetate.
English: Constipation, dyspepsia, gastritis, abdominal pain, dry mouth, abdominal discomfort, abdominal distension, gingivitis, melaena, toothache
Maltese: sedazzjoni, afażija, diżestiżija, distonija, letarġija, parożmijasindrome ċerebellari, aċċessjoni,
English: BIAL-Portela & Cª., S.A.
Maltese: BIAL-Portela & Cª., S.A. Teл.:
English: Zebinix 200 mg tablets Eslicarbazepine acetate
Maltese: Zebinix 200 mg pilloli Eslicarbazepine acetate
English: Severe cutaneous adverse reactions (SCARS), including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in post-marketing experience with Zebinix treatment (see section 4.4).
Maltese: Reazzjonijiet avversi severi tal-ġilda (SCARS, severe cutaneous adverse reactions) li jinkludu ssindromu ta' Stevens-Johnson (SJS)/nekrolisi epidermika tossika (TEN, toxic epidermal necrolysis) u reazzjoni għal mediċina b'eosinofilija u sintomi sistemiċi (DRESS, drug reaction with eosinophila and systemic symptoms), ġew irrappurtati fl-esperjenza ta' wara t-tqegħid fis-suq bit-trattament b'Zebinix (ara sezzjoni 4.4).
English: Eisai AB Tel: + 46 (0) 8 501 01 600
Maltese: Tel: + 46 (0) 8 501 01 600
English: In repeat-dose studies in juvenile dogs, the toxicity profile was comparable to that observed in adult animals.
Maltese: Fi studji dwar dożi ripetuti fi klieb ġuvenili, il-profil tat-tossiċità kien komparabbli għal dak osservat f'annimali adulti.
English: In the double-blind period of the phase III study, the least square mean reduction in standardised seizure frequency with eslicarbazepine acetate (-18.1% versus baseline) was different to placebo (8.6% versus baseline) but not statistically significant (p=0.2490).
Maltese: aċċessjonijiet standardizzati b'eslicarbazepine acetate (-18.1% kontra l-linja bażi) kienet differenti mill plaċebo (-8.6% kontra l-linja bażi) imma mhux statistikament sinifikanti (p = 0.2490).
English: EU/1/09/514/007 30 tablets - ALU/ALU blister EU/1/09/514/008 60 tablets - ALU/ALU blister EU/1/09/514/009 30 tablets - PVC/ALU blister EU/1/09/514/010 60 tablets - PVC/ALU blister
Maltese: EU/1/09/514/007 30 pillola - ALU/ALU folji EU/1/09/514/008 60 pillola - ALU/ALU folji EU/1/09/514/009 30 pillola - PVC/ALU folji
English: The pharmacokinetics of eslicarbazepine acetate is linear and dose-proportional in the range 400-1,200 mg both in healthy subjects and patients.
Maltese: Il-farmakokinetika ta' eslicarbazepine acetate hija lineari u proporzjonali għad-doża fil-medda 400-1,200 mg kemm f'persuni f'saħħithom kif ukoll fil-pazjenti.
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-esponiment sistemiku għal simvastatin meta ngħata flimkien ma' eslicarbazepine acetate 800 mg darba kuljum, li x'aktarx kien ikkawżat minn induzzjoni ta' CYP3A4.
English: At this age the intrinsic activity of the elimination process has not yet reached maturation.
Maltese: F'din l-età, l-attività intrinsika tal-proċess ta' eliminazzjoni ma tkunx għadha laħqet il-maturazzjoni.
English: Alopecia, dry skin, hyperhidrosis, erythema, skin disorder, pruritus, dermatitis allergic
Maltese: disturb tal-ġilda, ħakk, dermatite allerġika
English: Aluminium/Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 7, 14 or 28 tablets.
Maltese: Il-pilloli huma ppakkjati f'folji f'kaxxi tal-kartun li fihom 7, 14 jew 28 pillola.
English: In the subsequent 3 open-label extensions (ITT set N=148), the overall responder rate was 26.6% when compared to baseline Parts III-V (i.e. the last 4 weeks in part II).
Maltese: Fit-3 estensjonijiet open-label sussegwenti (sett ITT N = 148), ir-rata globali ta' dawk li rrispondew kienet ta' 26.
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 t-twaħħil tal-proteini tal-plażma ma kienx affettwat b'mod rilevanti mill-preżenza ta' warfarin, diazepam, digoxin, phenytoin u tolbutamide.
English: Eslicarbazepine acetate is extensively converted to eslicarbazepine.
Maltese: Eslicarbazepine acetate jinbidel b'mod estensiv għal eslicarbazepine.
English: 14 patients (9.2%) completed open-label treatment with ESL through Part V. The most common reason for withdrawal during any part of the study was sponsor request (30 patients in part III [19.7% of the patients who entered part III], 9 in part IV [9.6% of the patients who entered part IV], and 43 in part V [64.2% of the patients who entered Part V]).
Maltese: III], 9 f'parti IV [9.6% tal-pazjenti li daħlu f'parti IV], u 43 f'parti V [64.2% tal pazjenti li daħlu f'Parti V]).
English: The least square mean reduction in standardised seizure frequency from baseline to maintenance period was significantly (p<0.001) higher with eslicarbazepine acetate (-34.8%) compared to placebo (13.8%).
Maltese: Ittnaqqis fil-medja tal-least squares fil-frekwenza ta' aċċessjonijiet standardizzati mil-linja bażi sal perjodu ta' manteniment, kienet ogħla b'mod sinifikanti (p< 0.001) b'eslicarbazepine acetate (-34.8%) meta mqabbla mal-plaċebo (-13.8%).
English: The binding of eslicarbazepine to plasma proteins is relatively low (<40%) and independent from concentration.
Maltese: It-twaħħil ta' eslicarbazepine mal-proteini fil-plażma huwa relattivament baxx (<40%) u indipendenti mill-konċentrazzjoni.
English: White oblong tablets, engraved ‘ESL 600'on one side and scored on the other side, with a length of 17.3 mm.
Maltese: Il-pilloli għandhom ‘ESL 600' imnaqqxa fuq naħa waħda u huma mnaqqxin b'sinjal fuq in-naħa l-oħra, b'tul ta' 17.3 mm.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza dettaljati filRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: zebinix 800 mg (outer pack only)
Maltese: zebinix 800 mg (pakkett ta' barra biss)
English: Zebinix 400 mg tablets Eslicarbazepine acetate
Maltese: Zebinix 400 mg pilloli Eslicarbazepine acetate
English: PR interval
Maltese: Intervall tal-PR
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/ALU blister
Maltese: ALU/ALU folji PVC/ALU folji
English: The efficacy of eslicarbazepine acetate as conversion to monotherapy was evaluated in 2 double-blind, randomized controlled studies in 365 adult patients with partial-onset seizures.
Maltese: L-effikaċja ta' eslicarbazepine acetate bħala konverżjoni għal monoterapija ġiet evalwata f'2 studji double-blind, ikkontrollati, li fihom il-parteċipanti ntgħażlu b'mod każwali, li saru fuq 365 pazjent adult b'aċċessjonijiet ta' bidu parzjali.
English: Zebinix 600 mg tablets Eslicarbazepine acetate
Maltese: Zebinix 600 mg pilloli Eslicarbazepine acetate
English: Liver centrilobular hypertrophy was seen in repeated-dose toxicity studies in mice and rats and an increased incidence of liver tumours was observed in the carcinogenicity study in mice; these findings are consistent with an induction of hepatic microsomal enzymes, an effect which has not been observed in patients receiving eslicarbazepine acetate.
Maltese: Ipertrofija ċentrilobulari tal-fwied dehret fl-istudji tat-tossiċità dwar dożi ripetuti fil-ġrieden u fil-firien u ġiet osservata żieda fl-inċidenza ta' tumuri tal-fwied fl-istudju dwar il-karċinoġeniċità fil-ġrieden; dawn ir-riżultati huma konsistenti ma' induzzjoni ta' enzimi mikrosomali tal-fwied, effett li ma ġiex osservat f'pazjenti li jirċievu eslicarbazepine acetate.
English: In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4 (e.g. Simvastatin).
Maltese: Eslicarbazepine in vivo wera effett li jinduċi fuq il-metaboliżmu ta' prodotti mediċinali li primarjament jiġu eliminati minn metaboliżmu permezz ta' CYP3A4
English: EU/1/09/514/012 20 tablets - ALU/ALU blister EU/1/09/514/013 30 tablets - ALU/ALU blister EU/1/09/514/014 60 tablets - ALU/ALU blister EU/1/09/514/015 90 tablets - ALU/ALU blister EU/1/09/514/016 20 tablets - PVC/ALU blister EU/1/09/514/017 30 tablets - PVC/ALU blister EU/1/09/514/018 60 tablets - PVC/ALU blister EU/1/09/514/019 90 tablets - PVC/ALU blister
Maltese: EU/1/09/514/014 60 pillola - ALU/ALU folji EU/1/09/514/015 90 pillola - ALU/ALU folji EU/1/09/514/016 20 pillola - PVC/ALU folji EU/1/09/514/017 30 pillola - PVC/ALU folji
English: zebinix 200 mg (outer pack only)
Maltese: zebinix 200 mg (pakkett ta' barra biss)
English: Zebinix 200 mg tablets
Maltese: Zebinix 200 mg pilloli
English: Because of the prevalence of this allele in other Asian populations (e.g, above 15% in the Philippines and Malaysia), testing genetically at risk populations for the presence of HLA- B*1502 may be considered.
Maltese: Minħabba l-prevalenza ta' dan l-allele f'popolazzjonijiet Asjatiċi oħrajn (eż. iktar minn 15% f'nies Filippini u Malasjani), jista' jiġi kkunsidrat ittestjar għal popolazzjonijiet li qegħdin f'riskju ġenetiku għall-preżenza ta' HLA- B*1502.
English: Hyponatraemia has been reported as an adverse reaction in 1.5% of patients treated with Zebinix.
Maltese: L-iponatremija ġiet irrappurtata bħala reazzjoni avversa f' 1.5% ta' pazjenti kkurati b'Zebinix.
English: Psychotic disorder, apathy, depression, nervousness, agitation, irritability, attention deficit/ hyperactivity disorder, confusional state, mood swings, crying, psychomotor retardation, anxiety
Maltese: irritabilità,distur b ta' nuqqas ta' attenzjoni/iperat tività, stat konfużjonali,
English: • Neurological movement disorder where your muscles contract causing twisting and repetitive movements or abnormal postures.
Maltese: • Disturb newroloġiku fil-moviment, fejn il-muskoli jinġibdu u jikkawżaw tgħawwiġ u movimenti ripetittivi jew qagħdiet mhux normali.
English: Zebinix 800 mg tablets
Maltese: Zebinix 800 mg pilloli
English: In placebo-controlled studies involving patients aged from 2 to 18 years with partial-onset seizures (238 patients treated with eslicarbazepine acetate and 189 with placebo), 35.7% of patients treated with eslicarbazepine acetate and 19% of patients treated with placebo experienced adverse reactions.
Maltese: Fi studji kkontrollati bi plaċebo li kienu jinvolvu pazjenti li kellhom bejn sentejn u 18-il sena b'aċċessjonijiet b'bidu parzjali, ikkurati b'eslicarbazepine acetate (238 pazjent ikkurati b'eslicarbazepine acetate u 189 bi plaċebo), 35.7% tal-pazjenti kkurati b'eslicarbazepine acetate u 19% tal-pazjenti kkurati bi plaċebo, kellhom reazzjonijiet avversi.
English: Rash developed as an adverse reaction in 1.2% of total population treated with Zebinix in clinical studies in epileptic patients.
Maltese: Bħala reazzjoni avversa żviluppa raxx f'1.2% mill-popolazzjoni totali kkurata b'Zebinix fi studji kliniċi f'pazjenti epilettiċi.
English: If you have kidney problems you will usually be given a lower dose of Zebinix.
Maltese: Jekk għandek problemi kliewi, inti normalment se tingħata doża aktar baxxa ta' Zebinix.
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-esponiment għall-metabolit attiv eslicarbazepine, li x'aktarx kien ikkawżat minn induzzjoni ta' glukoronidazzjoni.
English: • adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.
Maltese: • terapija miżjuda f'adulti, adolexxenti u tfal li jkollhom aktar minn 6 snin, b'aċċessjonijiet ta' bidu parzjali b'ġeneralizzazzjoni sekondarja jew mingħajrha.
English: Rare adverse reactions such as bone marrow depression, anaphylactic reactions, 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 dipressjoni fil-mudullun, reazzjonijiet anafilattiċi, lupus erythematosus sistemiku jew arritmija kardijaka serja ma seħħewx matul studji kkontrollati bi plaċebo tal-programm tal-epilessija b'eslicarbazepine acetate.
English: • the blood thinner - warfarin;
Maltese: • Żieda fil-proteini tal-għadam;
English: Other form of this medicine, like oral suspension, maybe more suitable for children.
Maltese: Forma oħra ta' din il-mediċina, bħal suspensjoni orali, tista' tkun aktar adattata għat-tfal.
English: Interactions with other antiepileptic medicinal products
Maltese: Interazzjonijiet ma' prodotti mediċinali antiepilettiċi oħrajn
English: Severe cutaneous adverse reactions (SCARS) including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in post-marketing experience with Zebinix treatment.
Maltese: Johnson (SJS, Stevens-Johnson syndrome)/nekrolisi epidermika tossika (TEN, toxic epidermal necrolysis) u reazzjoni għal mediċina b'eosinofilija u sintomi sistemiċi (DRESS, drug reaction with eosinophila and systemic symptoms), ġew irrappurtati fl-esperjenza ta' wara t-tqegħid fis-suq bittrattament b'Zebinix.
English: The information currently provided in section 4.9 of the SmPC is limited and does not reflect a potential cardiac risk of eslicarbazepine acetate overdose or the risk of seizure induction.
Maltese: L-informazzjoni pprovduta bħalissa f'sezzjoni 4.9 tal-SmPC hija limitata u ma tirriflettix riskju kardijaku potenzjali ta' doża eċċessiva b'eslicarbazepine acetate jew ir-riskju ta' induzzjoni ta' aċċessjoni.
English: Do not stop taking your oral suspension suddenly.
Maltese: Tiqafx tieħu s-suspensjoni orali f'daqqa.
English: • carbamazepine (a medicine used to treat epilepsy) since your dose may have to be adjusted and the following side effects of Zebinix may occur in higher frequency: seeing double, abnormal coordination and dizziness;
Maltese: • carbamazepine (mediċina użata għall-kura tal-epilessija) għax id-doża tiegħek jista' jkollha bżonn li tiġi aġġustata u l-effetti sekondarji li ġejjin ta' Zebinix jistgħu jseħħu bi frekwenza ogħla: tara doppju, koordinament mhux normali u sturdament.
English: In patients with CLCR <30 ml/min use is not recommended due to insufficient data.
Maltese: F'pazjenti b'CLCR <30 ml/min, l-użu mhuwiex rakkomandat minħabba dejta insuffiċjenti.
English: zebinix 600 mg (outer pack only)
Maltese: zebinix 600 mg (pakkett ta' barra biss)
English: HLA-B* 1502 in individuals of Han Chinese and Thai origin has been shown to be strongly associated with the risk of developing the severe cutaneous reactions known as Stevens Johnson syndrome (SJS) when treated with carbamazepine.
Maltese: Intwera li HLA-B* 1502 f'individwi ta' oriġini Ħan Ċiniża u Tajlandiża hu assoċjat ħafna mar-riskju li jiżviluppaw reazzjonijiet severi tal-ġilda magħrufa bħala sindrome ta' Stevens-Johnson (SJS) meta jiġu kkurati b'carbamazepine.
English: Forty-two patients (50.6%) in the eslicarbazepine acetate group compared to 10 patients (25.0%) in the placebo group were responders (≥50% reduction of standardised seizure frequency), resulting in a significant difference (p=0.009).
Maltese: Tnejn u erbgħin pazjent (50.6%) fil-grupp ta' eslicarbazepine acetate meta mqabbla ma' 10 pazjenti (25.0%) fil-grupp tal-plaċebo rrispondew għall-kura, u dan irriżulta f'differenza sinifikanti (p = 0.009).