natgillin/translations-raw huggingface dataset:
In patients concomitantly treated with carbamazepine and eslicarbazepine acetate in placebocontrolled studies, the following adverse reactions were observed: diplopia (11.4% of subjects with concomitant carbamazepine, 2.4% of subjects without concomitant carbamazepine), abnormal coordination (6.7% with concomitant carbamazepine, 2.7% without concomitant carbamazepine), and dizziness (30.0% with concomitant carbamazepine, 11.5% without concomitant carbamazepine), see section 4.5.
U bolesnika istodobno liječenih karbamazepinom i eslikarbazepinacetatom u placebom kontroliranim studijama primijećene su sljedeće nuspojave: diplopija (11,4% ispitanika koji su istodobno primali karbamazepin, 2,4% ispitanika koji nisu istodobno primali karbamazepin), poremećaj koordinacije (6,7% s istodobnom primjenom karbamazepina, 2,7% bez istodobne primjene karbamazepina), i omaglica (30,0% s istodobnom primjenom karbamazepina, 11,5% bez istodobne primjene karbamazepina), vidjeti dio 4.5.
In clinical studies (adjunctive therapy treatment and monotherapy), 2,434 patients with partial-onset seizures were treated with eslicarbazepine acetate (1,983 adult patients and 451 paediatric patients) and 51% of those patients experienced adverse reactions.
U kliničkim ispitivanjima (kao dodatna terapija i kao monoterapija), 2434 bolesnika s parcijalnim napadajima liječeno je eslikarbazepinacetatom (1983 odraslih i 451 pedijatrijski bolesnik), 51% tih bolesnika imalo je nuspojave.
200 ml bottle oral syringe (10 ml) (outer pack only)
oralna suspenzija boca od 200 ml štrcaljka za usta (10 ml) (samo vanjsko pakiranje)
Zebinix may be taken with or without food.
Zebinix se može uzimati s hranom ili bez nje.
Zebinix contains methyl parahydroxybenzoate (E218) and sulphites
Zebinix sadrži metilparahidroksibenzoat (E218) i sulfite
• Disturbances in the sense of smell;
• Smetnje osjeta mirisa;
The median relative change was larger in the previous placebo group (-51.4%) than in the previous ESL group (
Median relativne promjene bio je veći u prethodnoj placebo skupini (-51,4%) nego u prethodnoj ESL skupini (-40,4%).
The most common adverse reaction in the group treated with eslicarbazepine acetate were diplopia (5.0%), somnolence (8.0%) and vomiting (4.6%).
Najčešće nuspojave u skupini liječenoj eslikarbazepinacetatom bile su diplopija (5,0%), somnolencija
Hypertension (including hypertensive crisis), hypotension, orthostatic hypotension, flushing, peripheral coldness
(uključujući hipertenzivnu krizu), hipotenzija, ortostatska hipotenzija, navale crvenila, periferna hladnoća
Urticaria and angioedema cases have been reported in patients taking Zebinix.
Prijavljeni su slučajevi urtikarije i angioedema u bolesnika koji su uzimali Zebinix.
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).
(Kaplan-Meierova analiza i Coxova regresija), Kaplan-Meierova procjena za rizik pojave napadaja na kraju razdoblja evaluacije iznosila je 0,06 u skupini liječenoj karbamazepinom i 0,12 u skupini liječenoj eslikarbazepinacetatom, a nakon 1 godine s dodatnim povećanjem rizika na 0,11 u skupini liječenoj karbamazepinom i 0,19 u skupini liječenoj eslikarbazepinacetatom (p = 0,0002).
• Medicine toxicity;
• Toksičnost lijeka;
Liver disorder
Poremećaji jetre
• Irritability;
• Nespretnost;
20 tablets 30 tablets 60 tablets 90 tablets
20 tableta 30 tableta 60 tableta 90 tableta
Zebinix tablets may be taken with or without food.
Tablete Zebinix se mogu uzimati s hranom ili bez nje.
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.
Studija u zdravih ispitanika nije pokazala utjecaj eslikarbazepinacetata 1200 mg jednom dnevno na farmakokinetiku digoksina, sugerirajući da eslikarbazepinacetat nema nikakav utjecaj na transporter Pglikoprotein.
Zebinix is not recommended if you have severe kidney problems.
Zebinix se ne preporučuje ako imate tešku bolest bubrega.
The pharmacokinetics of eslicarbazepine acetate has not been evaluated in patients with severe hepatic impairment.
Farmakokinetika eslikarbazepinacetata nije ispitivana u bolesnika s teškim oštećenjima jetre.
• Feeling unsteady or having a sensation of spinning or floating;
• Osjećaj nestabilnosti ili osjećaj vrtnje ili plutanja; • Mučnina ili povraćanje;
What you need to know before you take Zebinix 3.
Što morate znati prije nego počnete uzimati Zebinix
Zebinix 50 mg/ml oral suspension Eslicarbazepine acetate
Zebinix 50 mg/ml oralna suspenzija eslikarbazepinacetat
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.
Stoga se savjetuje da, dok uzimate Zebinix, koristite druge oblike sigurne i učinkovite kontracepcije sve do kraja tekućeg menstrualnog ciklusa nakon prekida liječenja.
Similar to adults, eslicarbazepine acetate is extensively converted to eslicarbazepine.
Slično kao u odraslih, eslikarbazepinacetat se opsežno pretvara u eslikarbazepin.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS ALU/ALU blister
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER Al/Al blister
Uncommon (may affect up to 1 in 100 people) side effects are:
Manje česte (mogu se javiti kod do 1 na 100 osoba) nuspojave su:
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).
U 3 otvorena nastavka ispitivanja (ITT N = 148) koja su uslijedila, ukupna stopa bolesnika koja je imala odgovor na terapiju iznosila je 26,6% u usporedbi s početnim vrijednostima u dijelovima III-V (tj. u 4 posljednja tjedna dijela II).
Psychotic disorder, apathy, depression, nervousness, agitation, irritability, attention deficit/ hyperactivity disorder, confusional state, mood swings, crying, psychomotor retardation, anxiety
poremećaji apatija, depresija, nervoza, agitacija, razdražljivost, deficit pažnje/ hiperaktivni poremećaj, konfuzno stanje, promjene raspoloženja, plač,
MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/ALU blister
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER PVC/Al blister
HPDE bottles carton and HPDE bottles of 90 tablets
Kutija s HPDE bocama i HPDE boce s 90 tableta
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.
Manji metaboliti u plazmi su R-likarbazepin i okskarbazepin, koji su aktivni te konjugati glukuronske kiseline s eslikarbazepinacetatom, eslikarbazepin, R-likarbazepin i okskarbazepin.
Seizure-free rates during the entire 10-week monotherapy period were 7.6% (1,600 mg) and 8.3 % (1,200 mg) in one study and 10.0% (1,600 mg) and 7.4 % (1,200 mg) in the other study, respectively.
(1200 mg) u jednom, odnosno 10,0% (1600 mg) i 7,4% (1200 mg) u drugom ispitivanju.
Take special care with Zebinix:
Budite posebno oprezni kada uzimate Zebinix:
Dosage should be increased in weekly or bi-weekly increments of 10 mg/kg/day up to 30 mg/kg/day,based on individual response.
Dozu treba povećavati svakog tjedna ili svaka dva tjedna za 10 mg/kg/dan do najviše 30 mg/kg/dan, ovisno o individualnom odgovoru.
How to take Zebinix
Kako uzimati Zebinix
Common (may affect up to 1 in 10 people) side effects are:
Česte (mogu se javiti kod do 1 na 10 osoba) nuspojave su:
Dizziness; somnolence; vertigo; asthenia; gait disturbance; tremor; ataxia; balance disorder; vision blurred; diarrhoea; rash and hyponatraemia were less common in children than in adults.
Omaglica, somnolencija, vrtoglavica, astenija, poremećaj hoda, tremor, ataksija, poremećaj ravnoteže, zamućen vid, proljev, osip i hiponatrijemija bili su manje česti u djece nego u odraslih.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 20, 30, 60 or 90 tablets
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija s 20, 30, 60 ili 90 tableta
• 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);
• U početku simptomi slični gripi, osip po licu koji se potom širi, visoka tjelesna temperatura, porast razine jetrenih enzima, odstupanja u rezultatima krvnih pretraga (eozinofilija), povećani limfni čvorovi i zahvaćenost drugih organa (osip uzrokovan lijekom s eozinofilijom i sistemskim simptomima, poznata i kao DRESS ili sindrom preosjetljivosti na lijek);
In the age group from 6 to 11 years of age, the most common adverse reaction observed in more than two patients treated with eslicarbazepine acetate were diplopia (9.5%), somnolence (7.4%), diziness (6.3%), convulsion (6.3%) and nausea (3.2%); in the age group from 12 to 18 years were somnolence (7.4%), vomiting (4.2%), diplopia (3.2%) and fatigue (3.2%).
U dobnoj skupini od 6 do 11 godina najčešće nuspojave primijećene u više od dva bolesnika liječena eslikarbazepinacetatom bile su diplopija (9,5%), somnolencija (7,4%), omaglica (6,3%), konvulzije (6,3%) i mučnina (3,2%); u dobnoj skupini od 12 do 18 godina bile su to somnolencija (7,4%), povraćanje (4,2%), diplopija (3,2%) i umor (3,2%).
Children with a body weight of 60 kg or more should be given the same dose as for adults.
Djeci tjelesne težine 60 kg ili više potrebno je davati iste doze kao i odraslima.
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.
Djelotvornost eslikarbazepinacetata kod prelaska na monoterapiju procjenjivana je u 2 dvostruko slijepa, randomizirana, kontrolirana ispitivanja na 365 odraslih bolesnika s parcijalnim napadajima.
Eslicarbazepine acetate is extensively converted to eslicarbazepine, which is mainly eliminated by glucuronidation.
Eslikarbazepinacetat se opsežno konvertira u eslikarbazepin, koji se uglavnom eliminira putem glukuronidacije.
Amber glass bottles with HDPE child resistant closures containing 200 ml oral suspension, inside a cardboard box.
Boce od smeđeg stakla s HDPE zatvaračem sigurnim za djecu koje sadrže 200 ml oralne suspenzije, u kartonskim kutijama.
• phenytoin (a medicine used to treat epilepsy) since your dose may need to be adjusted;
• fenitoin (lijek za liječenje epilepsije) jer će možda biti potrebno prilagoditi dozu.
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.
Eslikarbazepin može in vivo imati inducirajući učinak na metabolizam lijekova koji se uglavnom eliminiraju konjugacijom putem UDP-glukuronil transferaze.
HPDE bottles carton and HPDE bottles of 60 tablets
Kutija sa HPDE bocama i HPDE boce sa 60 tableta
• blistering or peeling of the skin and/or mucous membranes, rash, swallowing or breathing problems, swelling of your lips, face, eyelids, throat or tongue.
• Stvaranje mjehurića po koži ili ljuštenje kože i/ili sluznica, osip, poteškoće gutanja ili disanja, oticanje usana, lica, vjeđa, grla ili jezika.
Constipation, dyspepsia, gastritis, abdominal pain, dry mouth, abdominal discomfort, abdominal distension, gingivitis , melaena, toothache
Konstipacija, dispepsija, gastritis, bol u abdomenu, suha usta, nelagoda u abdomenu, distenzija abdomena, gingivitis, melena, zubobolja
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).
- CLCR 30-60 ml/min: početna doza od 200 mg (ili 5 mg/kg u djece starije od 6 godina) jedanput dnevno ili 400 mg (ili 10 mg/kg u djece starije od 6 godina) svaki drugi dan kroz 2 tjedna, nakon toga jedanput dnevno doza od 400 mg (ili 10 mg/kg u djece starije od 6 godina).
It is unknown whether eslicarbazepine acetate is excreted in human milk.
Nije poznato izlučuje li se eslikarbazepinacetat u majčino mlijeko kod ljudi.
PVC/Aluminium blisters placed into cardboard boxes containing 20 or 60 tablets.
PVC/aluminij blisteri u kartonskim kutijama koje sadrže 20 ili 60 tableta.
Although the robustness of these post-hoc subgroup analyses is limited, the data suggest an age and dose dependent increase in effect size.
Iako je robusnost ovih post-hoc analiza podskupina ograničena,
• simvastatin (a medicine used to lower cholesterol levels) since your dose may have to be adjusted;
• simvastatin (lijek za smanjenje razine kolesterola) jer će možda biti potrebno prilagoditi Vašu dozu.
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%).
Smanjenje srednje vrijednosti dobivene metodom najmanjih kvadrata za standardiziranu učestalost napadaja, od početnih vrijednosti do razdoblja održavanja, bilo je značajno veće (p<0,001) za eslikarbazepinacetat (-34,8%) u usporedbi s placebom (-13,8%).
Tel: + 39 02 518 1401
Eisai S.r.l. Tel: + 39 02 518 1401
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).
Korištena je sljedeća konvencija za klasifikaciju pojave nuspojava: vrlo često ≥1/10, često ≥1/100 i <1/10,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 7, 14 or 28 tablets
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija sa 7, 14 ili 28 tableta
Plasma levels of eslicarbazepine acetate usually remain below the limit of quantification, following oral administration.
Nakon peroralne primjene, plazmatske razine eslikarbazepinacetata obično ostaju ispod granice kvantifikacije.
Aluminium/Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 7, 14 or 28 tablets.
Aluminij/aluminij ili PVC/aluminij blisteri u kartonskim kutijama koje sadrže 7, 14 ili 28 tableta.
• Anxiety.
• Tjeskoba.
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%).
Najčešće pojedinačne nuspojave bile su omaglica (12,5% ispitanika), somnolencija (9,7%), umor, konvulzije i hiponatrijemija (svaka 8,3%), nazofaringitis (6,9%) i infekcija gornjih dišnih puteva (5,6%).
In studies in healthy subjects and epileptic adult patients, the apparent half-life of eslicarbazepine was 10-20 hours and 13-20 hours, respectively.
U ispitivanjima u zdravih ispitanika prividni poluvijek eslikarbazepina je od 10-20 sati, odnosno u epileptičkih odraslih bolesnika, 13-20 sati.
HLA-B* 1502 allele - in Han Chinese, Thai and other Asian populations
Prisutnost alela HLA-B*1502 u populacijama pripadnika kineskog naroda Han, pripadnika naroda Tai i pripadnika drugih azijskih naroda
Always use the oral syringe provided to take your medicine.
Za uzimanje lijeka uvijek koristite priloženu štrcaljku za usta.
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.
U ispitivanju u zdravih ispitanika, istodobna primjena eslikarbazepinacetata 1200 mg jednom dnevno i topiramata nije pokazala značajne promjene u izloženosti eslikarbazepinu, nego 18% smanjenu ekspoziciju topiramatu, najvjerojatnije uzrokovanu smanjenom bioraspoloživosti topiramata.
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.
U ispitivanju u zdravih ispitanika, istodobna primjena eslikarbazepinacetata 800 mg jednom dnevno i karbamazepina 400 mg dva puta dnevno rezultirala je u prosjeku padom od 32% u izloženosti aktivnom metabolitu eslikarbazepinu, najvjerojatnije uzrokovan indukcijom glukuronidacije.
Table 1: Treatment emergent adverse reactions associated with Zebinix obtained from in clinical studies and post-marketing surveillance
Tablica 1: Nuspojave nastale tijekom liječenja povezane s primjenom Zebinixa tijekom kliničkih ispitivanja i praćenja nakon stavljanja lijeka u promet
• Feeling extremely sleepy;
• Osjećaj izrazite pospanosti;
Adverse reactions associated with eslicarbazepine acetate obtained from clinical studies and postmarketing surveillance are tabulated below.
Tablični prikaz nuspojava Nuspojave povezane s eslikarbazepinacetatom prikupljene tijekom kliničkih ispitivanja i praćenjem lijeka nakon njegovog stavljanja u promet, prikazane su u tablici u nastavku.
Method and route of administration Zebinix is for oral use.
Način i put primjene Zebinix se uzima kroz usta.
Replace the closure on the bottle by turning it clock-wise (to the right).
8. korak: Vratite zatvarač na bocu i zakrenite ga u smjeru kazaljke na satu (prema desno).
Zebinix is used: • on its own (monotherapy) in adult patients with newly diagnosed epilepsy
• sam (kao monoterapija) u odraslih bolesnika s novodijagnosticiranom epilepsijom
• Burning sensation;
• Osjećaj žarenja;
Eslicarbazepine acetate metabolites are eliminated from the systemic circulation primarily by renal excretion.
Metaboliti eslikarbazepinacetata su eliminirani iz sistemske cirkulacije primarno preko bubrega.
Eslicarbazepine acetate was tested at doses of 20 and 30 mg/kg/day, up to a maximum of 1,200 mg/day.
Eslikarbazepinacetat ispitan je u dozama od 20 i 30 mg/kg/dan, do maksimalne doze od 1200 mg/dan.
EU/1/09/514/021 20 tablets - PVC/ALU blister EU/1/09/514/022 60 tablets - PVC/ALU blister
EU/1/09/514/021 20 tableta - PVC/Al blister EU/1/09/514/022 60 tableta - PVC/Al blister
Zebinix is not recommended in patients with severe liver problems.
Zebinix se ne preporučuje u bolesnika s teškim bolestima jetre.
• Heart burn, stomach upset, abdominal pain, abdominal bloating and discomfort or dry mouth;
• Žgaravica, nadražaj želuca, bol u trbuhu, nadimanja i nelagoda u trbuhu ili suha usta;
Children with a body weight of ≥60 kg Children with a body weight of 60 kg or more should be given the same dose as for adults.
Djeca tjelesne težine ≥60 kg Djeca tjelesne težine 60 kg i više trebaju uzimati doze jednake onima za odrasle.
CONDITIONS O R RESTRICTIONS REGARDING SUPPLY AND USE
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I
Myalgia, bone metabolism disorder, muscular weakness, pain in extremity
slabost u mišićima, bol u ekstremitetima
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.
Tablete su pakirane u blistere u kartonskim kutijama, koje sadrže 20, 30, 60 ili 90 tableta ili višestruka pakovanja koja sadrže 180 (2x90) tableta, i u HDPE boce sa zatvaračem sigurnim za djecu, u kartonskim kutijama koje sadrže 90 tableta.
20 tablets 60 tablets
20 tableta 60 tableta
There was no effect on the Rwarfarin pharmacokinetics or on coagulation.
Nije bilo nikakvog utjecaja na farmakokinetiku R
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
Tijekom liječenja Zebinixom, preporučuje se prilagodba doze u bolesnika, odraslih i djece starije od 6 godina, s klirensom kreatinina <60 ml/min (vidjeti dio 4.2).
30 tablets 60 tablets
30 tableta 60 tableta
Alopecia, dry skin, hyperhidrosis, erythema, skin disorder, pruritus, dermatitis allergic
Alopecija, suha koža, hiperhidroza, eritem,
Zebinix is not recommended in patients with severe renal disease.
Zebinix se ne preporučuje kod bolesnika sa teškim bolestima bubrega.
• Migraine;
• Glavobolja;
Be careful, do not push the plunger down when removing the oral syringe from the bottle.
Pazite da dok vadite štrcaljku za usta ne pritisnite klip prema dolje.
• Skin rash;
• Osip kože;
Step 4.
Prilog IV.
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
EU/1/09/514/012 20 tableta - Al/Al blister EU/1/09/514/013 30 tableta - Al/Al blister EU/1/09/514/014 60 tableta - Al/Al blister EU/1/09/514/015 90 tableta - Al/Al blister EU/1/09/514/016 20 tableta - PVC/Al blister EU/1/09/514/017 30 tableta - PVC/Al blister EU/1/09/514/018 60 tableta - PVC/Al blister EU/1/09/514/019 90 tableta - PVC/Al blister
Aluminium /Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 30 or 60 tablets.
Aluminij/aluminij ili PVC/aluminij blisteri u kartonskim kutijama koje sadrže 30 ili 60 tableta.
The most common 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.
Najčešće prijavljene nuspojave, tijekom placebom kontroliranih ispitivanja dodatne terapije u odraslih bolesnika s epilepsijom i u aktivno kontroliranom ispitivanju monoterapije u kojem se eslikarbazepinacetat uspoređivao s karbamazepinom s kontroliranim oslobađanjem, bile su omaglica, somnolencija, glavobolja i mučnina.
• Seeing double or blurred vision;
• Dvostruke slike ili zamućenje vida;
• with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children patients above 6 years of age, who are experiencing seizures that affect one part of the brain (partial seizure).
• zajedno s drugim antiepilepticima (kao dodatna terapija) u odraslih bolesnika, adolescenata i djece starije od 6 godina, kojiimaju napadaje koji zahvaćaju jedan dio mozga (parcijalni napadaji).
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%).
25,8%) nego u bolesnika koji su primali placebo (-16,4%).
• with other antiepileptic medicines (adjunctive therapy), in adult, adolescents and children patients above 6 years of age who are experiencing seizures that affect one part of the brain (partial seizure).
• zajedno s drugim antiepilepticima (kao dodatna terapija) u odraslih bolesnika, adolescenata i djece starije od 6 godina koji imaju napadaje koji zahvaćaju jedan dio mozga (parcijalni napadaji).
The efficacy of eslicarbazepine acetate as monotherapy has been demonstrated in a double-blind, active controlled (carbamazepine controlled release) study, involving 815 randomized adult patients with newly diagnosed partial-onset seizures.
Djelotvornost eslikarbazepinacetata kao monoterapije dokazana je u dvostruko slijepom, aktivno kontroliranom (karbamazepin s kontroliranim oslobađanjem) ispitivanju, koje je uključivalo 815
Two clusters of ADRs were identified in context of overdose cases - epilepsy/seizures/status epilepticus and cardiac events, mainly arrhythmias.
napadaji / status epileptikus i kardijalni događaji, uglavnom aritmije.
Package leaflet: Information for the user Zebinix 50 mg/ml oral suspension
Uputa o lijeku: Informacije za korisnika Zebinix 50 mg/ml oralna suspenzija eslikarbazepinacetat