FrancophonIA/ELRC3.0 huggingface dataset:
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'persuni b'saħħithom b'eslicarbazepine acetate 1,200 mg darba kuljum wera interazzjoni farmakokinetika medja minuri (esponiment ta' lamotrigine naqas bi 15%) bejn eslicarbazepine acetate u lamotrigine u konsegwentement ma huma meħtieġa l-ebda aġġustamenti tad-doża.
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: eslicarbazepine u l-glucuronide tiegħu jikkorrispondu għal iktar minn 90% tal-metaboliti totali eliminati fl-awrina, madwar żewġ terzi fil-forma mhux mibdula u terz bħala konjugat ta' glucuronide.
English: HPDE bottles carton and HPDE bottles of 90 tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 90 pillola.
English: Zebinix 600 mg tablets
Maltese: Zebinix 600 mg pilloli
English: Zebinix 400 mg tablets
Maltese: Zebinix 400 mg pilloli
English: Second or third degree atrioventricular (AV) block.
Maltese: Tieni jew tielet sadd atrijoventrikulari (AV)blokk.
English: Toxic epidermal necrolysis, StevensJohnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, urticaria
Maltese: toxic epidermal necrolysis) u reazzjoni għal mediċina b'eosinofilija u sintomi sistemiċi (DRESS, drug reaction with eosinophila and systemic symptoms), li jistgħu jkunu ta' periklu għall-ħajja jew fatali,
English: Hypertension (including hypertensis crisis), hypotension, orthostatic hypotension, flushing, peripheral coldness
Maltese: Pressjoni għolja (inkluż kriżi ipertensiva), pressjoni baxxa, pressjoni ortostatika baxxa, fawra, kesħa periferali
English: As clinical data are limited in patients with mild to moderate hepatic impairment and pharmacokinetic and clinical data are missing in patients with severe hepatic impairment, eslicarbazepine acetate should be used with caution in patients with mild to moderate hepatic impairment and is not recommended in patients with severe hepatic impairment.
Maltese: Minħabba li d-dejta klinika hi limitata f'pazjenti b'indeboliment epatiku ħafif sa moderat u minħabba li dejta farmakokinetika u klinika hi nieqsa f'pazjenti b'indeboliment epatiku sever, eslicarbazepine acetate għandu jintuża b'attenzjoni f'pazjenti b'indeboliment epatiku ħafif sa moderat u mhuwiex rakkomandat f'pazjenti b'indeboliment epatiku sever.
English: Adverse reactions 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: Reazzjonijiet avversi osservati fi studji fuq l-annimali seħħew f'livelli ta' esponiment ferm iktar baxxi mil-livelli ta' esponiment kliniku għal eslicarbazepine (il-metabolit prinċipali u farmakoloġikament attiv ta' eslicarbazepine acetate).
English: Of these, 65 patients had received ESL and 87 patients had received placebo during the double-blind part of the study.
Maltese: 65 pazjent kienu rċivew ESL u 87 pazjenti kienu rċivew plaċebo matul il-parti double-blind tal-istudju.
English: • Reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, red and swollen eyes and can be preceded by fever and/or flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis);
Maltese: • Tbajja' ħamranin jew irqajja' tondi li ta' sikwit jidhru flimkien ma' nfafet fuq il-parti ċentrali tal ġisem, tqaxxir tal-ġilda, ulċeri tal-ħalq, tal-gerżuma, tal-imnieħer, tal-ġenitali u tal-għajnejn, u għajnejn ħomor u minfuħin li jistgħu jkunu bid-deni li jseħħ qabel u/jew sintomi li jixbhu l influwenza (sindromu ta' Stevens-Johnson/nekrolisi epidermika tossika);
English: (increase of ≥25%) compared to Baseline Parts III-V was 25.7%.
Maltese: Il-proporzjon globali ta' pazjenti b'aggravament (żieda ta' ≥ 25%) meta mqabbel mal-Partijiet fil-Linja Bażi III-V kien ta' 25.
English: In the analysis of treatment failure (seizure risk) based on time to event analysis (Kaplan-Meier analysis and Cox regression), the Kaplan-Meier estimates of seizure risk at the end of the evaluation period was 0.06 with carbamazepine and 0.12 with eslicarbazepine acetate and by the end of 1 year with an additional increased risk to 0.11 with carbamazepine and 0.19 with eslicarbazepine acetate (p=0.0002).
Maltese: 46%, intervall ta' kunfidenza ta' 95%: [-11.88; 0.97]. Fl-analiżi ta' kura li ma rnexxietx (riskju ta' aċċessjoni) ibbażata fuq il-ħin sal analiżi tal-avveniment (analiżi Kaplan-Meier u rigressjoni Cox), l-istimi Kaplan-Meier ta' riskju ta' aċċessjoni fit-tmiem tal-perjodu ta' evalwazzjoni kienu ta' 0.06 b'carbamazepine u 0.
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic active substances in several indications.
Maltese: Ideazzjoni u mġiba suwiċidali ġew irrappurtati f'pazjenti kkurati b'sustanzi attivi antiepilettiċi f'diversi indikazzjonijiet.
English: The tablets are packaged in blisters in cardboard boxes containing 20, 30, 60 or 90 tablets or in multipacks containing 180 (2x90) 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 jew f' pakketti b'ħafna li jkun fihom 180 (2x90) pillola, u fi fliexken tal-HDPE b'għatu li ma jistax jinfetaħ mit-tfal f'kaxxi tal-kartun li fihom 90 pillola.
English: The tablets have ‘ESL 400'engraved on one side and are scored on the other side, with a diameter of 11 mm.
Maltese: Il-pilloli għandhom ‘ESL 400' imnaqqxa fuq naħa waħda u huma mnaqqxin b'sinjal fuq in-naħa l-oħra, b'dijametru ta' 11 mm.
English: Fatigue, gait disturbance, asthenia
Maltese: nervożiżmu, aġitazzjoni,
English: Haemodialysis removes eslicarbazepine acetate metabolites from plasma.
Maltese: L-effikaċja ta' eslicarbazepine acetate bħala terapija miżjuda ntweriet fi erba studji ta' fażi
English: Moderate hepatic impairment did not affect the pharmacokinetics of eslicarbazepine acetate.
Maltese: Indeboliment epatiku moderat ma affettwax il-farmakokinetika ta' eslicarbazepine acetate.
English: If you develop a serious rash or another skin symptoms (see section 4), stop taking Zebinix and contact your doctor or seek medical attention immediately.
Maltese: Jekk tiżviluppa raxx serju jew sintomi tal-ġilda oħra (ara sezzjoni 4), waqqaf it-teħid ta' Zebinix u kkuntattja lit-tabib tiegħek jew fittex attenzjoni medika immedjatament.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 20, 30, 60 or 90 tablets
Maltese: Kaxxa ta' 20, 30, 60 jew 90 pillola
English: • with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children patients above 6 years of age, whoare experiencing seizures that affect one part of the brain (partial seizure).
Maltese: • ma' mediċini oħrajn kontra l-epilessija (terapija miżjuda), f'pazjenti adulti, adolexxenti u tfal li jkollhom aktar minn 6 snin, li jkun qed ikollhom aċċessjonijiet li jaffettwaw parti mill-moħħ (aċċessjoni parzjali).
English: Safety margins based on comparative exposure have thus not been established.
Maltese: Għaldaqstant għadu ma ġiex stabbilit marġini ta' sigurtà bbażat fuq esponiment komparattiv.
English: Methyl parahydroxybenzoate (E218)
Maltese: Xanthan gum (E415) Macrogol-100 stearate Methyl parahydroxybenzoate (E218) Saccharin sodium (E954)
English: The most common treatment-emergent adverse reactions reported, in placebo controlled adjunctive therapy studies with adult epileptic patients and in an active controlled monotherapy study comparing eslicarbazepine acetate with carbamazepine controlled release, were dizziness, somnolence, headache, and nausea.
Maltese: L-iktar avvenimenti avversi rrappurtati b'mod komuni, fl-istudji dwar terapija miżjuda kkontrollata bi plaċebo fuq pazjenti adulti epilettiċi, u fi studju dwar monoterapija kkontrollat b'mod attiv li qabbel eslicarbazepine acetate ma' carbamazepine li jintreħa b'mod ikkontrollat, kienu sturdament, ngħas, uġigħ ta' ras u nawsja.
English: A study in healthy subjects showed no effect of eslicarbazepine acetate 1,200 mg once daily on digoxin pharmacokinetics, suggesting that eslicarbazepine acetate has no effect on the transporter Pglycoprotein.
Maltese: Studju f'persuni f'saħħithom ma wera l-ebda effett ta' eslicarbazepine acetate 1,200 mg darba kuljum fuq il-farmakokinetika ta' digoxin, li jissuġġerixxi li eslicarbazepine acetate m'għandux effett fuq it trasportatur P-glycoprotein.
English: Based on individual response, the dose may be increased to 1,200 mg once daily Some patients on monotherapy regimen may benefit from a dose of 1,600 mg once daily (see section 5.1).
Maltese: Xi pazjenti fuq il-kors ta' monoterapija jistgħu jibbenefikaw minn doża ta' 1,600 mg darba kuljum (ara sezzjoni 5.1).
English: Eslicarbazepine has inhibiting properties with respect to CYP2C19.
Maltese: Eslicarbazepine għandu karatteristiċi inibitorji fir-rigward ta' CYP2C19.
English: Uncommon (may affect up to 1 in 100 people) side effects are:
Maltese: Effetti sekondarji mhux komuni (li jistgħu jaffettwaw sa 1 kull 100 persuna) huma:
English: Urticaria and angioedema cases have been reported in patients taking Zebinix.
Maltese: Hemm dejta limitata fuq kors ta' monoterapija disponibbli fil-popolazzjoni anzjana.
English: • phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;
Maltese: • phenytoin (mediċina użata biex tikkura l-epilessija) peress lid-doża tiegħek tista' teħtieġ li tkun aġġustata.
English: • Muscle pain, pain in limbs, muscular weakness;
Maltese: • Uġigħ fil-muskoli, uġigħ fid-dirgħajn u r-riġlejn, dgħufija fil-muskoli
English: Taking into consideration the limitations of open label uncontrolled data, the long-term response to eslicarbazepine acetate in the open-label parts of the study was overall maintained.
Maltese: Meta wieħed jikkunsidra l-limitazzjonijiet ta' dejta open-label mhux ikkontrollata, ir-rispons fit-tul għal eslicarbazepine acetate fil-partijiet open-label tal-istudju kien miżmum b'mod globali.
English: Multiple antiepileptic medicinal product therapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practised whenever possible.
Maltese: Kura multipla bi prodott mediċinali kontra l-epilessija tista' tkun assoċjata ma' riskju ogħla ta' malformazzjonijiet konġenitali milli b'monoterapija, u għaldaqstant huwa importanti li kull fejn possibbli, tiġi pprattikata monoterapija.
English: The use of eslicarbazepine acetate is associated with increase in the PR interval.
Maltese: Fi studji kliniċi b'eslicarbazepine acetate, ġie osservat titwil fl-intervall tal-PR.
English: • Initially flu-like symptoms, rash on the face then widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome);
Maltese: • Inizjalment sintomi li jixbhu l-influwenza, raxx fuq il-wiċċ imbagħad raxx mifrux, temperatura tal ġisem għolja, żidiet tal-enzimi fil-fwied, anormalitajiet fid-demm (eosinofilija), glandoli limfatiċi minfuħin u involviment ieħor tal-organi tal-ġisem (Reazzjoni tal-Mediċina b'Eosinofilija u Sintomi Sistemiċi li huma magħrufa wkoll bħala DRESS jew sindromu ta' sensittività eċċessiva għallmediċina);
English: Step 3.
Maltese: Pass 2.
English: Eslicarbazepine is a weak inducer of CYP3A4 and has inhibiting properties with respect to CYP2C19 (as stated in section 4.5).
Maltese: CYP2C19 (kif iddikjarat fl-sezzjoni 4.5).
English: The maximum dose is 1,200 mg once daily.
Maltese: 1,200 mg darba kuljum.
English: In studies with eslicarbazepine in fresh human hepatocytes a mild induction of UGT1A1 mediated glucuronidation was observed.
Maltese: glukuronidazzjoni medjata mill-UGT1A1.
English: How to store Zebinix
Maltese: X'fih Zebinix
English: Study 208 included 2 additional subsequent long-term, open-label extensions (1 year in part II and 2 years in part III) and Study 305 included 4 subsequent long-term, open-label extension periods (1 year in Parts II, III and IV and 2 years in Part V).
Maltese: Studju 208 kien jinkludi żewġ estensjonijiet open-label fuq tul ta' żmien addizzjonali u sussegwenti (sena f'parti II u sentejn f'parti
English: Based on a structural relationship of eslicarbazepine acetate to tricyclic antidepressants, an interaction between eslicarbazepine acetate and MAOIs is theoretically possible.
Maltese: Interazzjoni bejn eslicarbazepine acetate u MAOIs hija teoretikament possibbli, ibbażat fuq relazzjoni strutturali ta' eslicarbazepine acetate għal antidepressanti triċikliċi.
English: White oblong tablets, engraved 'ESL 200' on one side and scored on the other side, with a length of 11 mm.
Maltese: Pilloli bojod tawwalin, imnaqqxin b'‘ESL 200' fuq naħa waħda u mnaqqxin b'sinjal fuq in-naħa l-oħra, b'tul ta' 11 mm.
English: The tablets have ‘ESL 800'engraved on one side and are scored on the other side, with a length of 19 mm.
Maltese: Il-pilloli għandhom ‘ESL 800' imnaqqxa fuq naħa waħda u huma mnaqqxin b'sinjal fuq in-naħa l-oħra, b'tul ta' 19 mm.
English: No change in exposure to carbamazepine or its metabolite carbamazepine-epoxide was noted.
Maltese: Ma kienet osservata l-ebda bidla fl-esponiment għal carbamazepine jew il-metabolit tiegħu carbamazepine-epoxide.
English: • if you are allergic to eslicarbazepine acetate, to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients of this medicine (listed in section 6);
Maltese: • jekk inti allerġiku għal eslicarbazepine acetate, għal xi derivattivi carboxamide oħrajn (ngħidu aħna, carbamazepine jew oxcarbazepine, mediċini użati biex jikkuraw l-epilessija) jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6)
English: If patients of these ethnic origins are tested positive for HLA- B*1502 allele, the use of eslicarbazepine acetate may be considered if the benefits are thought to exceed risks.
Maltese: Jekk il-pazjenti ta' dawn l-oriġini etniċi jkollhom riżultat pożittiv fit-test għal allele HLA- B*1502, l-użu ta' eslicarbazepine acetate jista' jiġi kkunsidrat jekk ikun maħsub li l-benefiċċji jiżbqu r-riskji.
English: Switching preparations
Maltese: Qlib tal-preparazzjonijiet
English: Eslicarbazepine acetate metabolites can effectively be cleared by haemodialysis, if necessary (see section 5.2).
Maltese: 1200 mg ta' eslicarbazepine acetate darba kuljum, rispettivament (ara sezzjoni 4.2).
English: Similar to adults, eslicarbazepine acetate is extensively converted to eslicarbazepine.
Maltese: Bħal fil-każ tal-adulti, eslicarbazepine acetate jiġi mibdul b'mod estensiv għal eslicarbazepine.
English: Coordination abnormal, memory impairment, amnesia, hypersomnia, sedation, aphasia, dysaesthesia, dystonia, lethargy, parosmia, cerebellar syndrome, convulsion, peripheral neuropathy, nystagmus, speech disorder, dysarthria, burning sensation, paraesthesia, migraine
Maltese: Fil-biċċa l-kbira mill-każijiet, l-iponatremija hija bla sintomi, madankollu, tista' tkun akkompanjata minn sintomi kliniċi bħall-aggravament tal-attakki ta' puplesija, konfużjoni, konoxxenza mnaqqsa.
English: A study in adult patients with mild to severe renal impairment showed that clearance is dependent on renal function.
Maltese: Studju f'pazjenti adulti b'indeboliment renali ħafif sa sever wera li r-rata ta' eliminazzjoni hija dipendenti fuq il-funzjoni renali.
English: Drug toxicity, fall, thermal burn
Maltese: Tossiċità għallmediċina, waqgħat, ħruq termali
English: The majority of adverse reactions were reported in <3% of subjects in any treatment group.
Maltese: Il-maġġoranza reazzjonijiet avversi kienu rrappurtati fi <3% tal-individwi fi kwalunkwe grupp ta' kura.
English: Forty-one patients (30.6%) in the eslicarbazepine acetate group compared to 40 patients (31.0%) in the placebo group were responders (≥50% reduction of standardised seizure frequency), resulting in a non-significant difference (p=0.9017).
Maltese: 6%) fil-grupp ta' eslicarbazepine acetate meta mqabbla ma' 40 pazjenti (31.0%) fil-grupp tal-plaċebo kellhom rispons għall-kura (tnaqqis ta' ≤ 50% fil-frekwenza standardizzata ta'
English: The presence of HLA-A*3101 allele may increase the risk for carbamazepine induced cutaneous reactions (mostly less severe) from 5.0% in general population to 26.0% among subjects of European ancestry, whereas its absence may reduce the risk from 5.0% to 3.8%.
Maltese: Il-preżenza tal-allele HLA-A*3101 tista' żżid ir-riskju għal reazzjonijiet tal-ġilda kkaġunati minn carbamazepine (il-biċċa l-kbira inqas severi) minn 5.0% fil-popolazzjoni ġenerali sa 26.
English: The oral suspension is packaged in amber glass bottles with HDPE child resistant closures containing 200 ml oral suspension, inside a cardboard box.
Maltese: Is-suspensjoni orali hi ppakkjata fi fliexken tal-ħġieġ ta' lewn safrani b'għatjien tal-HDPE li ma jistgħux jinfetħu mit-tfal, li fihom 200 ml suspensjoni orali, f'kaxxa tal-kartun.
English: During the reporting period, the MAH detected a signal of overdose.
Maltese: Dawn jistgħu jkunu sinjali ta' reazzjoni allerġika.
English: Nausea, vomiting, diarrhoea
Maltese: Stitikezza, dispepsija, gastrite,
English: Results from patient studies showed that concomitant treatment increased the risk of the following adverse reactions: diplopia, abnormal coordination and dizziness.
Maltese: Riżultati minn studji li saru fuq pazjenti wrew li kura fl-istess ħin żiedet ir-riskju tar-reazzjonijiet avversi li ġejjin: diplopja, koordinazzjoni anormali, u sturdament.
English: Other medicines and Zebinix
Maltese: Mediċini oħra u Zebinix
English: The proportion of patients with exacerbation (increase of ≥25%) compared to the baseline period was 14.2%.
Maltese: Il-proporzjon ta' pazjenti b'aggravament (żieda ta' ≥ 25%) meta mqabbel mal-perjodu tal-linja bażi kien ta' 14.2%.
English: HPDE bottles carton and HPDE bottles of 60 tablets
Maltese: Pakkett ta' fliexken HDPE u fliexken HDPE ta' 60 pillola
English: Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects.
Maltese: L-aktar li jiġu rrappurtati huma qasma fix xoffa, malformazzjonijiet kardjovaskulari u difetti fit-tubu newrali.
English: HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
Maltese: Fliexken HDPE b'għatu li ma jinfetaħx mit-tfal, impoġġijin f'kaxex tal-kartun, li fihom 90 pillola.
English: • Clumsiness;
Maltese: anġjodema,
English: • Underactive thyroid gland.
Maltese: • Diffikultà biex torqod
English: The CHMP recommends that the terms of the marketing authorisation(s) should be varied.
Maltese: MAH (Marketing Authorisation Holder - Detentur tal-Awtorizzazzjoni għat-Tqegħid fuq is-Suq).
English: Ossification delays, reduced foetal weights, an increase in minor skeletal and visceral anomalies were observed at maternal toxic doses in embryotoxicity studies in mice, rats and rabbits.
Maltese: Dewmien flossifikazzjoni, tnaqqis fil-piżijiet tal-feti, żieda f'anomaliji minuri skeletriċi u vixxerali, ġew osservati f'dożi li kienu tossiċi għall-omm fi studji dwar l-embrijotossiċità fil-ġrieden, fil-firien u fil-fniek.
English: Thrombocytopenia, leukopenia
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Zebinix may be taken as monotherapy or added to existing anticonvulsant therapy.
Maltese: Zebinix jista' jittieħed bħala monoterapija jew jiżdied ma' terapija eżistenti kontra l-konvulżjonijiet.
English: Risk related to epilepsy and antiepileptic medicinal products in general It has been shown that in the offspring of women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population.
Maltese: għandu prevalenza ta' 2 sa 5% fil-popolazzjonijiet Ewropej u madwar 10% fil-popolazzjoni Ġappuniża.
English: Plasma levels of eslicarbazepine acetate usually remain below the limit of quantification, following oral administration.
Maltese: Il-livelli ta' eslicarbazepine acetate fil-plażma normalment jibqgħu taħt il-limitu ta' kwantifikazzjoni, wara l għoti orali.
English: Oxcarbazepine and felbamate were not allowed as concomitant medicinal products in these studies.
Maltese: Oxcarbazepine u felbamate ma tħallewx bħala prodotti mediċinali konkomitanti f'dawn l-istudji.
English: • if you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels.
Maltese: • jekk inti ssofri minn konfużjoni, aggravar ta' puplesiji jew tnaqqis fil-konoxxenza li jistgħu jkunu sinjali ta' livelli baxxi ta' melħ fid-demm
English: • Diarrhoea;
Maltese: • Deidratazzjoni
English: • Urticaria (skin rash with itching).
Maltese: • Urtikarja (raxx tal-ġilda bil-ħakk).
English: The pharmacokinetics of eslicarbazepine acetate has not been evaluated in patients with severe hepatic impairment (see sections 4.4 and 5.2) and use in these patients is, therefore, not recommended.
Maltese: Il- farmakokinetika ta' eslicarbazepine acetate ma ġietx evelwata f'pazjenti b'indeboliment epatiku sever (ara sezzjonijiet 4.4 u 5.2) u għaldaqstant, l-użu f'dawn il-pazjenti mhuwiex rakkomandat.
English: Impairment of fertility was observed in female rats; decreases in implantations and live embryos seen in the mouse fertility study may also indicate effects on female fertility, however, corpora lutea counts were not evaluated.
Maltese: Ġie osservat indeboliment tal-fertilità f'firien nisa; ġie osservat tnaqqis fl-impjantazzjonijiet u embrijuni ħajjin fl-istudju dwar il-fertilità fil-ġrieden, li jista' jindika wkoll effetti fuq il-fertilità fin-nisa,
English: • do not take oxcarbazepine (a medicine used to treat epilepsy) with Zebinix, as it is not known whether it is safe to take these medicines together.
Maltese: • tiħux oxcarbazepine (mediċina użata biex tikkura l-epilessija) ma' Zebinix, minħabba li mhuwiex magħruf jekk huwiex perikoluż li tieħu dawn il-mediċini flimkien.
English: Each tablet contains 800 mg of eslicarbazepine acetate.
Maltese: b'carbamazepine u 0.19 b'eslicarbazepine acetate (p=0.0002).
English: 400 mg (or 10 mg/kg in children above 6 years) every other day for 2 weeks followed by a once daily dose of 400 mg (or 10 mg/kg in children above 6 years).
Maltese: - CLCR 30-60 ml/min: doża tal-bidu ta' 200 mg (jew 5 mg/kg fi tfal li jkollhom aktar minn 6 snin) darba kuljum jew 400 mg (jew 10 mg/kg fi tfal li jkollhom aktar minn 6 snin) darba iva u darba le għal ġimagħtejn segwita minn doża waħda kuljum ta' 400 mg (jew 10 mg/kg fi tfal li jkollhom aktar minn 6 snin).
English: BIAL-Portela & Cª., S.A. Tel.: + 351 22 986 61 00
Maltese: BIAL-Portela & Cª, S.A. Τηλ: + 351 22 986 61 00
English: • Thermal burn;
Maltese: • Ħruq termali
English: Evidence of nephrotoxicity was observed in repeated dose-toxicity studies in the rat, but was not seen in studies in mice or dogs, and is consistent with an exacerbation of spontaneous chronic progressive nephropathy in this species.
Maltese: Evidenza ta' nefrotossiċità ġiet osservata fi studji dwar tossiċità minn dożi ripetuti fil-firien, iżda din ma dehritx fi studji fuq il-ġrieden jew il-klieb, u hija konsistenti mat-taħrix ta' nefropatija progressiva kronika spontanja f'din l-ispeċi.
English: Zebinix 800 mg tablets are white and oblong.
Maltese: Pilloli Zebinix 800 mg huma bojod u tawwalin.
English: • Urinary tract infection;
Maltese: • Infezzjoni fil-passaġġ urinarju
English: HDPE bottles with polypropylene child resistant closure, inside a cardboard box, containing 60 tablets.
Maltese: Fliexken HDPE b'għatu li ma jinfetaħx mit-tfal, impoġġijin f'kaxex tal-kartun, li fihom 60 pillola.
English: - CLCR 30-60 ml/min: initial dose of 200 mg (or 5 mg/kg in children above 6 years) once daily or
Maltese: - CLCR >60 ml/min: ma huwa meħtieġ l-ebda aġġustament tad-doża