FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: V dvojno slepem obdobju študije faze III je bilo povprečno zmanjšanje najmanjših kvadratov v standardizirani pogostnosti napadov z eslikarbazepinacetatom (-18,1 % glede na izhodišče) drugačno kot za placebo (-8,6 % glede na izhodišče), a ne statistično značilno (p = 0,2490).
English: Zebinix 400 mg tablets are white, circular and biconvex.
Slovenian: Tablete Zebinix 400 mg so bele, okrogle in bikonveksne.
English: Table 1: Treatment emergent adverse reactions associated with Zebinix obtained from in clinical studies and post-marketing surveillance
Slovenian: Preglednica 1: Zaradi zdravljenja nastali neželeni učinki, povezani z zdravilom Zebinix, v kliničnih študijah in iz izkušenj v obdobju trženja
English: Rash developed as an adverse reaction in 1.2% of total population treated with Zebinix in clinical studies in epileptic patients.
Slovenian: Kožne reakcije Pri 1,2 % celotne populacije bolnikov z epilepsijo, ki so zdravilo Zebinix prejemali v kliničnih študijah, se je kot neželen učinek pojavil izpuščaj.
English: The prevalence of HLA-B*1502 carrier is about 10% in Han Chinese and Thai populations.
Slovenian: Prevalenca nosilcev HLA-B*1502 je približno 10 %
English: • Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;
Slovenian: • zgaga, prebavne težave, bolečine v trebuhu, napihnjenost ali neprijeten občutek v trebuhu ali suha usta,
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.
Slovenian: Pri uporabi 1.200 mg eslikarbazepinacetata enkrat na dan pri ženskah, ki uporabljajo kombinirane peroralne kontraceptive, je prišlo do povprečnega 37-odstotnega zmanjšanja sistemske izpostavljenosti levonorgestrelu in 42-odstotnega zmanjšanja sistemske izpostavljenosti etinilestradiolu, ki je najverjetneje bilo posledica indukcije CYP3A4.
English: Taking into account that more eslicarbazepine acetate-treated patients experienced weight increase than weight decrease during the open label extension of the Phase III studies the current labelling is not considered adequate.
Slovenian: Povečanje telesne mase Glede na to, da je med bolniki, ki so bili zdravljeni z eslikarbazepinacetatom, v podaljšku študije faze III, ki je bil nezaslepljen, pri več bolnikih prišlo do povečanja telesne mase kot pa do zmanjšanja telesne mase, trenutno označevanje zdravila ni ustrezno.
English: PVC/Aluminium blisters placed into cardboard boxes containing 20 or 60 tablets.
Slovenian: Pretisni omoti iz PVC/aluminija, vloženi v kartonske škatle, ki vsebujejo 20 ali 60 tablet.
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.
Slovenian: V študiji pri zdravih osebah je sočasna uporaba 1.200 mg eslikarbazepinacetata enkrat na dan in fenitoina povzročila povprečno 31- do 33-odstotno zmanjšanje izpostavljenosti aktivnemu presnovku eslikarbazepinu, ki je najverjetneje bilo posledica indukcije glukuronidacije, in povprečno 31- do 35odstotno povečanje izpostavljenosti fenitoinu, ki je najverjetneje bilo posledica zaviranja CYP2C19.
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.
Slovenian: 10-20 h, pri odraslih bolnikih z epilepsijo pa 13-20 h. Manj pomembni presnovki v plazmi so R-likarbazepin in okskarbazepin, za katera so ugotovili, da sta aktivna, ter konjugati glukuronske kisline z eslikarbazepinacetatom, eslikarbazepinom, R-likarbazepinom in okskarbazepinom.
English: • Muscle pain, pain in limbs, muscular weakness;
Slovenian: • bolečine v mišicah, bolečine v okončinah, mišična šibkost,
English: Do not breast-feed while you are taking Zebinix.
Slovenian: Med jemanjem zdravila Zebinix ne dojite.
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.
Slovenian: Tablete so pakirane v pretisne omote v kartonskih škatlah, ki vsebujejo 20, 30, 60 ali 90 tablet ali skupno pakiranje ki vsebuje 180 (2x90) tablet, in v steklenice iz HDPE z za otroke varno zaporko v kartonskih škatlah, ki vsebujejo 90 tablet.
English: 30 tablets 60 tablets
Slovenian: 30 tablet 60 tablet
English: 20 tablets 60 tablets
Slovenian: 20 tablet 60 tablet
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
Slovenian: BIAL - Portela & Cª , SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado - Portugalska tel: +351 22 986 61 00 faks: +351 22 986 61 99 e-pošta: info@bial.com
English: The most common adverse reaction in the group treated with eslicarbazepine acetate were diplopia (5.0%), somnolence (8.0%) and vomiting (4.6%).
Slovenian: so bili diplopija (5,0 %), somnolenca (8,0 %) in bruhanje (4,6 %).
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);
Slovenian: • rdečkaste, tarčam podobne makule ali okrogle zaplate, pogosto z mehurji na sredi, ki se pojavijo na trupu, luščenje kože, razjede v ustih, grlu, nosu, spolovilih in očeh, rdeče in otekle oči, pred katerimi se lahko pojavijo zvišana telesna temperatura in/ali gripi podobni simptomi
English: zebinix 50 mg/ml (outer pack only)
Slovenian: zebinix 50 mg/ml (samo zunanja ovojnina)
English: Weight gain
Slovenian: Prevalenca alela
English: • Inflamed gums or toothache;
Slovenian: • vnete dlesni ali zobobol,
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.
Slovenian: 400 mg (samo v študijah 301 in 302), 800 mg in 1.200 mg enkrat na dan. Eslikarbazepinacetat pri odmerku 800 mg enkrat na dan in 1.200 mg enkrat na dan je bil bistveno učinkovitejši od placeba pri zmanjšanju pogostnosti epileptičnih napadov v 12-tedenskem vzdrževalnem obdobju.
English: Amber glass bottles with HDPE child resistant closures containing 200 ml oral suspension, inside a cardboard box.
Slovenian: Rjavkaste steklenice z za otroke varno zaporko iz HDPE, ki vsebujejo 200 ml peroralne suspenzije, v kartonski škatli.
English: Do not use this medicine after the expiry date, which is stated on the blister and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake »EXP«.
English: Children aged 6 years and below
Slovenian: Otroci, stari 6 ali manj let
English: The tablets are packaged in blisters in cardboard boxes containing 20 or 60 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 60 tablets.
Slovenian: Tablete so pakirane v pretisne omote v kartonskih škatlah, ki vsebujejo 20 ali 60 tablet, in v steklenice iz HDPE z za otroke varno zaporko v kartonskih škatlah, ki vsebujejo 60 tablet.
English: Replace the closure on the bottle by turning it clock-wise (to the right).
Slovenian: 8. korak: Zaporko namestite nazaj na steklenico z obračanjem v smeri urnega kazalca (v desno).
English: HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
Slovenian: Steklenice iz HDPE s polipropilensko za otroke varno zaporko, vložene v kartonske škatle, ki vsebujejo 90 tablet.
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
Slovenian: BIAL - Portela & Cª , S.A., À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugalska tel: +351 22 986 61 00 faks: +351 22 986 61 99 e-pošta: info@bial.com
English: Therefore it is recommended that you use other forms of safe and effective contraception, when taking Zebinix up to the end of the current menstrual cycle after stopping treatment.
Slovenian: Zato je med jemanjem zdravila Zebinix in do konca trenutnega menstrualnega cikla po končanem zdravljenju priporočeno uporabljati drugo obliko varne in učinkovite kontracepcije.
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
Slovenian: EU/1/09/514/012 20 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/013 30 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/014 60 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/015 90 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/016 20 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/017 30 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/018 60 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/019 90 tablet - Pretisni omot iz PVC/ALU
English: Eslicarbazepine acetate is extensively converted to eslicarbazepine.
Slovenian: Absorpcija Eslikarbazepinacetat se v veliki meri spremeni v eslikarbazepin.
English: Aluminium/Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 7, 14 or 28 tablets.
Slovenian: Pretisni omoti iz PVC/aluminija, vloženi v kartonske škatle, ki vsebujejo 7, 14 ali 28 tablet.
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.
Slovenian: Zaradi prevalence tega alela pri drugih azijskih populacijah (npr. več kot 15 % na Filipinih in v
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.
Slovenian: Pri uporabi strukturno sorodnih antiepileptikov, kot sta karbamazepin in okskarbazepin, so poročali o motnjah kosti, vključno z osteopenijo in osteoporozo (tanjšanjem kosti), ter o zlomih.
English: • Increased bone proteins;
Slovenian: • motnje v presnovi kosti, • zvišanje ravni kostnih beljakovin,
English: • Migraine;
Slovenian: • migrena,
English: Aluminium /Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 30 or 60 tablets.
Slovenian: Pretisni omoti iz PVC/aluminija, vloženi v kartonske škatle, ki vsebujejo 30 ali 60 tablet.
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%).
Slovenian: utrujenost (8,3 %), konvulzije (8,3 %), hiponatriemija (8,3 %), nazofaringitis (6,9 %) in okužba zgornjih dihal (5,6 %).
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic active substances in several indications.
Slovenian: Pri bolnikih, ki so se zaradi različnih indikacij zdravili z antiepileptiki, so poročali o samomorilnih mislih in vedenju.
English: Constipation, dyspepsia, gastritis, abdominal pain, dry mouth, abdominal discomfort, abdominal distension, gingivitis , melaena, toothache
Slovenian: neprijeten občutek v trebuhu, abdominalna distenzija, gingivitis, melena, zobobol pankreatitis
English: The doses of the active comparator, carbamazepine controlled release, were 200 mg, 400 mg and 600 mg, twice-daily.
Slovenian: Eslikarbazepinacetat so preskušali v odmerkih 800 mg, 1.200 mg in 1.600 mg z odmerjanjem enkrat na dan. Odmerki aktivnega primerjalnega zdravila, karbamazepina z nadzorovanim sproščanjem, so bili 200 mg, 400 mg in 600 mg z odmerjanjem dvakrat na dan.
English: Myalgia, bone metabolism disorder, muscular weakness, pain in extremity
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva mialgija, motnje v presnovi kosti, mišična šibkost, bolečina v okončinah
English: A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Slovenian: Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih s placebom nadzorovanih kliničnih preskušanj antiepileptikov.
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
Slovenian: EU/1/09/514/001 7 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/002 14 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/003 28 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/004 7 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/005 14 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/006 28 tablet - Pretisni omot iz PVC/ALU
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 30 or 60 tablets
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 30 ali 60 tabletami
English: The starting dose is 10 mg per kg body weight taken once a day for one or two weeks, before increasing to the maintenance dose.
Slovenian: Začetni odmerek je 10 mg na kg telesne mase, ki se jemlje enkrat na dan en teden ali dva tedna,
English: • Clumsiness;
Slovenian: • nerodnost,
English: How to store Zebinix
Slovenian: Shranjevanje zdravila Zebinix
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/ALU blister
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Pretisni omot iz PVC/ALU
English: • Severe pain in the back and stomach (caused by inflamation of the pancreas);
Slovenian: • zmanjšanje števila trombocitov, ki zveča tveganje za krvavitve ali modrice, • hude bolečine v hrbtu ali trebuhu (ki jih povzroči vnetje trebušne slinavke),
English: Nausea, vomiting, diarrhoea
Slovenian: Bolezni prebavil navzea, bruhanje, diareja zaprtost, dispepsija,
English: • Thermal burn;
Slovenian: • toplotne opekline,
English: Turn the bottle upright and remove the entire oral syringe from the bottle.
Slovenian: 7. korak: Steklenico obrnite prav in odmerno brizgo odstranite iz steklenice.
English: • phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;
Slovenian: • fenitoin (zdravilo za zdravljenje epilepsije), ker bo morda moral prilagoditi odmerek; • karbamazepin (zdravilo za zdravljenje epilepsije), kajti morda bo treba prilagoditi odmerek;
English: Psychotic disorder, apathy, depression, nervousness, agitation, irritability, attention deficit/ hyperactivity disorder, confusional state, mood swings, crying, psychomotor retardation, anxiety
Slovenian: razdražljivost, motnje pozornosti/hiperaktivnost, stanje zmedenosti, spremembe razpoloženja,
English: HDPE bottles with polypropylene child resistant closure, inside a cardboard box, containing 60 tablets.
Slovenian: Steklenice iz HDPE s polipropilensko za otroke varno zaporko, vložene v kartonske škatle, ki vsebujejo 60 tablet.
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).
Slovenian: V obdobju trženja so pri zdravljenju z zdravilom Zebinix poročali o hudih kožnih neželenih reakcijah, vključno s Stevens-Johnsonovim sindromom (SJS)/toksično epidermalno nekrolizo (TEN) ter reakcijo na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS) (glejte poglavje 4.4).
English: Adverse reactions associated with eslicarbazepine acetate obtained from clinical studies and postmarketing surveillance are tabulated below.
Slovenian: V spodnji preglednici so prikazani z eslikarbazepinacetatom povezani neželeni učinki v kliničnih študijah in iz izkušenj v obdobju trženja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 20 or 60 tablets
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 20 ali 60 tabletami
English: Skin and subcutaneous tissue disorders
Slovenian: žolčnika in žolčevodov bolezni jeter
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.
Slovenian: V študijah embriotoksičnosti pri miših, podganah in kuncih so opazili zakasnitev okostenitve, zmanjšano maso fetusa, zvečanje manjših nenormalnosti okostja in drobovja.
English: Each ml of oral suspension contains 50 mg of eslicarbazepine acetate.
Slovenian: En ml peroralne suspenzije vsebuje 50 mg eslikarbazepinacetata.
English: • Feeling sick or vomiting;
Slovenian: • siljenje na bruhanje ali bruhanje,
English: The tablets have ‘ESL 600'engraved on one side and are scored on the other side, with a length of 17.3 mm.
Slovenian: Tablete imajo vtisnjen napis ‘ESL 600' na eni strani in zarezo na drugi, dolžine 17,3 mm. Tableta se lahko deli na enake odmerke.
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).
Slovenian: Pogostnost neželenih učinkov je razvrščena na naslednji način: zelo pogosti (≥ 1/10), pogosti (od
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).
Slovenian: - CLCR 30-60 ml/min: začetni odmerek 200 mg (ali 5 mg/kg pri otrocih, starih več kot 6 let) enkrat dnevno ali 400 mg (ali 10 mg/kg pri otrocih, starih več kot 6 let) vsak drugi dan 2 tedna, nato 400 mg (ali 10 mg/kg pri otrocih, starih več kot 6 let) enkrat dnevno.
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
Slovenian: EU/1/09/514/007 30 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/008 60 tablet - Pretisni omot iz ALU/ALU EU/1/09/514/009 30 tablet - Pretisni omot iz PVC/ALU EU/1/09/514/010 60 tablet - Pretisni omot iz PVC/ALU
English: Contains methyl parahydroxybenzoate (E218) and sulphites See leaflet for further information
Slovenian: Vsebuje metilparahidroksibenzoat (E218) in sulfite.
English: • Medicine toxicity; • Anxiety.
Slovenian: • tesnoba (anksioznost).
English: This leaflet was last revised in MM/YYYY
Slovenian: Navodilo je bilo nazadnje revidirano dne {mesec LLLL }.
English: • Sedation;
Slovenian: • sedacija,
English: Metabolism and nutrition disorders
Slovenian: Bolezni živčevja in očesne bolezni
English: White oblong tablets, engraved ‘ESL 600'on one side and scored on the other side, with a length of 17.3 mm.
Slovenian: Bele, podolgovate tablete z vtisnjenim napisom ‘ESL 600' na eni strani in zarezo na drugi strani, dolžine 17,3 mm. Tableta se lahko deli na enake odmerke.
English: Hyponatraemia has been reported as an adverse reaction in 1.5% of patients treated with Zebinix.
Slovenian: Pri 1,5 % bolnikov, ki so prejemali zdravilo Zebinix, se je kot neželeni učinek pojavila hiponatriemija.
English: Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with eslicarbazepine acetate.
Slovenian: Zato bo pri sočasni uporabi z eslikarbazepinacetatom morda treba povečati odmerek zdravil, ki se presnavljajo s CYP3A4.
English: zebinix 200 mg (outer pack only)
Slovenian: zebinix 200 mg (samo zunanja ovojnina)
English: White circular biconvex tablets, engraved ‘ESL 400'on one side and scored on the other side, with a diameter of 11 mm..
Slovenian: Bele, okrogle, bikonveksne tablete z vtisnjenim napisom ‘ESL 400' na eni strani in zarezo na drugi strani, premera 11 mm. Tableta se lahko deli na enake odmerke.
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).
Slovenian: 400 mg (ali 10 mg/kg pri otrocih, starih več kot 6 let) enkrat dnevno.
English: zebinix 800 mg (outer pack only)
Slovenian: zebinix 800 mg (samo zunanja ovojnina)
English: • Itching;
Slovenian: • driska,
English: • Burning sensation;
Slovenian: pekoč občutek,
English: The tablets have ‘ESL 800'engraved on one side and are scored on the other side, with a length of 19 mm.
Slovenian: Tablete imajo vtisnjen napis ‘ESL 800' na eni strani in zarezo na drugi, dolžine 19 mm. Tableta se lahko deli na enake odmerke.
English: The treatment effect observed during the 26-week evaluation period was maintained over 1 year of treatment with 64.7 % eslicarbazepine acetate subjects and 70.3 % carbamazepine controlled release subjects classified as seizure free (average risk difference -5.46%, 95% confidence interval: [-11.88; 0.97].
Slovenian: Učinek zdravljenja, ki so ga opazili v 26-tedenskem obdobju ocenjevanja, se je ohranil skozi obdobje enega leta zdravljenja, pri čemer je bilo 64,7 % bolnikov, zdravljenih z eslikarbazepinacetatom, in 70,3 % bolnikov, zdravljenih s karbamazepinom z nadzorovanim sproščanjem, ocenjenih, da nimajo epileptičnih napadov (povprečna razlika v tveganju
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.
Slovenian: Pri bolnikih, ki so se dolgotrajno zdravili s strukturno sorodnima antiepileptikoma karbamazepinom in okskarbazepinom, so poročali o zmanjšanju mineralne gostote kosti, osteopeniji, osteoporozi in zlomih.
English: Headache, disturbance in attention, tremor, ataxia, balance disorder
Slovenian: Omotica, somnolenca, vrtoglavica, astenija, motnje pri hoji, tremor,
English: During treatment with Zebinix dose adjustment is recommended in patients,adult and children above 6 years of age with creatinine clearance <60 ml/min (see section
Slovenian: Pri bolnikih, odraslih in otrocih, starih nad 6 let, s kreatininskim očistkom < 60 ml/min, je med zdravljenjem z zdravilom Zebinix priporočeno prilagoditi odmerek (glejte poglavje 4.2).
English: • Agitation;
Slovenian: • agitacija,
English: If patients of European descent or Japanese origin are known to be positive for HLA-A*3101 allele, the use of carbamazepine or chemically-related compounds may be considered if the benefits are thought to exceed risks.
Slovenian: A*3101, je mogoče o uporabi eslikarbazepinacetata razmisliti, če so pričakovane koristi večje od tveganj.
English: • Headache;
Slovenian: • glavobol,
English: zebinix 600 mg (outer pack only)
Slovenian: zebinix 600 mg (samo zunanja ovojnina)
English: Zebinix 200 mg tablets
Slovenian: Zebinix 200 mg tablete
English: Zebinix 800 mg tablets
Slovenian: Zebinix 800 mg tablete
English: White oblong tablets, engraved 'ESL 200' on one side and scored on the other side, with a length of 11 mm.
Slovenian: Bele, podolgovate tablete z vtisnjenim napisom ‘ESL 200' na eni strani in zarezo na drugi strani, dolžine 11 mm. Tableta se lahko deli na enake odmerke.
English: The pharmacokinetics of eslicarbazepine acetate has not been evaluated in patients with severe hepatic impairment.
Slovenian: Pri bolnikih s hudo jetrno okvaro farmakokinetike eslikarbazepinacetata niso ocenili.