FrancophonIA/ELRC3.0 huggingface dataset:
English: In the monotherapy clinical trial comparing lacosamide to carbamazepine CR, syncope was reported in 7/444 (1.6 %) lacosamide patients and in 1/442 (0.2 %) carbamazepine CR patients.
Croatian: U kliničkom ispitivanju monoterapije u kojem je lakozamid uspoređivan s karbamazepinom CR, sinkopa je zabilježena u 7/444 (1,6 %) bolesnika liječenih lakozamidom i u 1/442 (0,2 %) bolesnika liječenih karbamazepinom CR.
English: The paediatric pharmacokinetic profile of lacosamide was determined in a population pharmacokinetic analysis using sparse plasma concentration data obtained in one placebo-controlled randomised study and three open-label studies in 414 children with epilepsy aged 6 months to 17 years.
Croatian: Farmakokinetika lakozamida u pedijatrijskoj populaciji utvrđena je populacijskom farmakokinetičkom analizom na temelju oskudnih podataka o koncentraciji u plazmi prikupljenih u jednom placebom kontroliranom randomiziranom ispitivanju i tri otvorena ispitivanja u 414 djece s epilepsijom u dobi od 6 mjeseci do 17 godina.
English: Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgija.
English: Common: may affect up to 1 in 10 people Injection site pain or discomfort or irritation.
Croatian: Često: mogu se javiti u do 1 na 10 osoba • bol ili nelagoda ili iritacija na mjestu injekcije
English: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany.
Croatian: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Njemačka.
English: pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %).
Croatian: pireksija (13,0 %), konvulzije (7,8 %), smanjenje teka (5,9 %), faringitis (4,7 %), letargija (2,7 %) i abnormalno ponašanje (1,7 %).
English: In reproductive and developmental toxicity studies in rodents and rabbits, no teratogenic effects but an increase in numbers of stillborn pups and pup deaths in the peripartum period, and slightly reduced live litter sizes and pup body weights were observed at maternal toxic doses in rats corresponding to systemic exposure levels similar to the expected clinical exposure.
Croatian: U ispitivanjima reproduktivne i razvojne toksičnosti na glodavcima i kunićima nisu primijećeni teratogeni učinci, ali je primijećeno povećanje broja mrtvorođenih mladunaca i broja smrti u peripartalnom razdoblju te lagano smanjenje veličine živog legla i smanjenje tjelesne težine mladunaca kod izloženosti ženki dozama toksičnim za štakore, a koje odgovaraju razinama sistemske izloženosti sličnim očekivanoj kliničkoj izloženosti.
English: Therefore, dosage supplementation following haemodialysis is recommended (see section 4.2).
Croatian: Stoga se nakon hemodijalize preporučuje dodatna doza (vidjeti dio 4.2).
English: You would then start your ongoing maintenance dose 12 hours later.
Croatian: Zatim biste približno 12 sati poslije započeli s primjenom svoje stalne doze održavanja.
English: Partial-onset seizures have a similar clinical expression in children from 4 years of age and in adults.
Croatian: Parcijalni napadaji imaju sličnu kliničku sliku u djece od navršene 4 godine života i u odraslih.
English: Blood tests may show abnormal liver function, liver injury;
Croatian: • krvne pretrage mogu ukazivati na promijenjenu funkciju jetre, oštećenje jetre;
English: The precise volume of syrup is to be calculated according to the exact body weight of the child.
Croatian: Točan volumen sirupa treba izračunati s obzirom na točnu tjelesnu težinu djeteta.
English: No clinically relevant difference in lacosamide exposure was observed comparing its pharmacokinetics in extensive metabolisers (EMs, with a functional CYP2C19) and poor metabolisers (PMs, lacking a functional CYP2C19).
Croatian: Nije uočena klinički značajna razlika u izloženosti lakozamidu uspoređujući njegovu farmakokinetiku u ispitanika s brzim metabolizmom (s funkcionalnim CYP2C19) i u ispitanika sa sporim metabolizmom (s manjkom funkcionalnog CYP2C19).
English: Blood and lymphatic disorders
Croatian: Poremećaji krvi i limfnog sustava
English: The quality of life assessed by the Pediatric Quality of Life Inventory indicated that subjects in both lacosamide and placebo groups had a similar and stable health-related quality of life during the entire treatment period.
Croatian: Kvaliteta života procijenjena upitnikom kvalitete života za djecu i adolescente (Pediatric Quality of Life Inventory) pokazala je da su ispitanici i u skupni koja je primala lakozamid i u skupini koja je primala placebo imali istu stabilnu kvalitetu života povezanu sa zdravljem tijekom cijelog razdoblja liječenja.
English: In all patients with renal impairment, the dose titration should be performed with caution (see section 5.2).
Croatian: U svih bolesnika s oštećenjem bubrega treba oprezno titrirati dozu (vidjeti dio 5.2).
English: For all patients requiring haemodialysis a supplement of up to 50 % of the divided daily dose directly after the end of haemodialysis is recommended.
Croatian: Za sve bolesnike na hemodijalizi preporučuje se dodatna doza od maksimalno 50 % razdijeljene dnevne doze lijeka neposredno nakon hemodijalize.
English: Furthermore an interaction trial with omeprazole (CYP2C19-inhibitor) demonstrated no clinically relevant changes in lacosamide plasma concentrations indicating that the importance of this pathway is minor.
Croatian: Osim toga ispitivanje interakcija s omeprazolom (inhibitor CYP2C19) nije pokazalo klinički značajne promjene u koncentraciji lakozamida u plazmi što ukazuje na malu važnost tog puta.
English: Lacosamide is primarily eliminated from the systemic circulation by renal excretion and biotransformation.
Croatian: Lakozamid se primarno eliminira iz sistemske cirkulacije putem bubrega i biotransformacijom.
English: Lacosamide UCB solution for infusion is available in packages of 1 vial and 5 vials.
Croatian: Lakozamid UCB otopina za infuziju je dostupna u pakiranjima od 1 bočice i 5 bočica.
English: Convulsion(3)
Croatian: Konvulzije(3)
English: However, subgroup analysis in clinical trials did not identify an increased magnitude of PR prolongation in patients with concomitant administration of carbamazepine or lamotrigine.
Croatian: Međutim, analiza podskupina u kliničkim ispitivanjima nije pokazala povećan opseg produljenja PR-intervala kod bolesnika koji su istovremeno uzimali karbamazepin ili lamotrigin.
English: In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.
Croatian: U bolesnika kod kojih se javi ozbiljna srčana aritmija, potrebno je provesti kliničku procjenu koristi i rizika te po potrebi prekinuti liječenje lakozamidom.
English: Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
Croatian: • natrijev metilparahidroksibenzoat (E219) može uzrokovati alergijske reakcije (moguće i odgođene).
English: Patients weighing 50 kg or more: use the measuring cup.
Croatian: Bolesnici tjelesne težine 50 kg ili više: upotrebljavati mjernu čašu.
English: Abnormalities in liver function tests have been observed in placebo-controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic medicinal products.
Croatian: Poremećaji u testovima jetrene funkcije uočeni su tijekom placebom kontroliranih istraživanja s lakozamidom u odraslih bolesnika s parcijalnim napadajima koji su istovremeno uzimali 1 do 3 antiepileptička lijeka.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX18
Croatian: Farmakoterapijska skupina: antiepileptici, ostali antiepileptici, ATK oznaka: N03AX18
English: The plasma concentration of O-desmethyl-lacosamide is approximately 15 % of the concentration of lacosamide in plasma.
Croatian: Koncentracija O-dezmetil lakozamida u plazmi iznosi oko 15 % koncentracije lakozamida u plazmi.
English: Open the bottle by pressing the cap while turning it anti-clockwise (figure 1).
Croatian: Otvorite bocu tako da pritisnete zatvarač i zakrenete ga suprotno od smjera kazaljke na satu (slika 1).
English: There are two ways in which you can choose to drink the medicine: empty the contents of the oral syringe into a little water by pushing the piston to the bottom of the oral syringe (figure 11) - you will then need to drink all of the water (add just enough to make it easy to drink) or drink the solution directly from the oral syringe without water (figure 12) - drink the whole contents of the oral syringe.
Croatian: • ispraznite sadržaj štrcaljke za usta u malo vode gurajući klip do kraja štrcaljke za usta (slika 11) - zatim trebate popiti svu vodu (dodajte samo onoliko vode koliko je dovoljno da se lijek lako popije) ili
English: A polar fraction proposed to be serine derivatives accounted for approximately 20 % in urine, but was detected only in small amounts (0-2 %) in human plasma of some subjects.
Croatian: Polarna frakcija za koju se pretpostavlja da pripada derivatima serina bila je zastupljena s oko 20 % u mokraći, ali je u plazmi pojedinih ispitanika nađena samo u vrlo malim količinama (0-2 %).
English: Clinical trials indicate that gender does not have a clinically significant influence on the plasma concentrations of lacosamide.
Croatian: Klinička istraživanja pokazuju da spol nema klinički značajan utjecaj na koncentracije lakozamida u plazmi.
English: Listed below are the normal recommended doses of Lacosamide UCB for different age groups and weights.
Croatian: U nastavku su navedene uobičajene preporučene doze lijeka Lakozamid UCB za različite dobne skupine i tjelesne težine.
English: Lacosamide 600 mg/day was also shown to be effective in controlled adjunctive therapy trials, although the efficacy was similar to 400 mg/day and patients were less likely to tolerate this dose because of CNS- and gastrointestinal-related adverse reactions.
Croatian: Lakozamid se u dozi od 600 mg/dan također pokazao djelotvornim u kontroliranim istraživanjima dodatne terapije, iako je djelotvornost bila slična onoj pri dozi od 400 mg/dan i bolesnici su teže podnosili tu dozu zbog nuspojava SŽS-a i gastrointestinalnog trakta.
English: Lacosamide treatment has been associated with dizziness or blurred vision.
Croatian: Liječenje lakozamidom povezano je s omaglicom ili zamućenim vidom.
English: 100 mg/day or 200 mg/day 100 mg/day
Croatian: 100 mg/dan ili 200 mg/dan 100 mg/dan
English: The incidence rate for syncope reported in pooled adjunctive therapy clinical trials is uncommon and did not differ between lacosamide (n=944) treated epilepsy patients (0.1 %) and placebo (n=364) treated epilepsy patients (0.3 %).
Croatian: Stopa incidencije sinkope zabilježena u združenim kliničkim ispitivanjima dodatne terapije manje je česta i nije se razlikovala između bolesnika s epilepsijom (n = 944) koji su liječeni lakozamidom (0,1 %) i bolesnika s epilepsijom (n = 364) koji su dobivali placebo (0,3 %).
English: Strong enzyme inducers such as rifampicin or St John's wort (Hypericum perforatum) may moderately reduce the systemic exposure of lacosamide.
Croatian: Jaki induktori enzima poput rifampicina ili gospine trave (Hypericum perforatum) mogu umjereno smanjiti sistemsku izloženost lakozamidu.
English: Animal studies have shown excretion of lacosamide in breast milk.
Croatian: Ispitivanja na životinjama pokazala su da se lakozamid izlučuje u mlijeko.
English: 2 mg/kg/day every week
Croatian: 2 mg/kg/dan svakih tjedan dana
English: Children and adolescents below 50 kg The treatment initiation pack is not suitable for children and adolescents weighing less than 50 kg.
Croatian: Djeca i adolescenti tjelesne težine manje od 50 kg Pakiranje za početak liječenja nije prikladno za djecu i adolescente tjelesne težine manje od 50 kg.
English: Do not use Lacosamide UCB if any of the above applies to you.
Croatian: Nemojte upotrebljavati Lakozamid UCB ako se na Vas odnosi bilo koja od gornjih tvrdnji.
English: Dizziness Headache
Croatian: Omaglica Glavobolja
English: A safety pharmacology study with intravenous administration of lacosamide in anesthetised dogs showed transient increases in PR interval and QRS complex duration and decreases in blood pressure most likely due to a cardiodepressant action.
Croatian: U ispitivanju sigurnosne farmakologije u kojem je lakozamid primijenjen intravenski anesteziranim psima primijećeno je prolazno produljenje PR-intervala i proširenje QRS-kompleksa te sniženje krvnog tlaka, najvjerojatnije zbog kardiodepresivnog učinka.
English: Lacosamide protected against seizures in a broad range of animal models of partial and primary generalised seizures and delayed kindling development.
Croatian: Lakozamid je pokazao zaštitni učinak protiv napadaja u širokom rasponu animalnih modela parcijalnih i primarno generaliziranih konvulzija te odgođenog izbijanja iz epileptičkog žarišta.
English: If you take more Lacosamide UCB than you should If you have taken more Lacosamide UCB than you should, contact your doctor immediately.
Croatian: Ako ste uzeli više lijeka Lakozamid UCB nego što ste smjeli, odmah se obratite liječniku.
English: Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Lacosamide UCB patients and 0 % (0/356) of placebo patients.
Croatian: Povišene vrijednosti ALT-a do ≥ 3 x od gornje granice normale (GGN) zabilježene su u 0,7 % (7/935) bolesnika koji su uzimali Lakozamid UCB i u 0 % (0/356) bolesnika koji su uzimali placebo.
English: The renal clearance of lacosamide was only slightly reduced in elderly subjects in this study.
Croatian: Bubrežni klirens lakozamida bio je neznatno snižen kod starijih ispitanika u tom ispitivanju.
English: The discontinuation rate due to adverse events observed with lacosamide was 21.0 % (13/62) in elderly patients versus 9.2 % (35/382) in younger adult patients.
Croatian: Stopa prekida liječenja zbog nuspojava zabilježenih s lakozamidom bila je 21,0 % (13/62) u starijih bolesnika naspram 9,2 % (35/382) u mlađih odraslih bolesnika.
English: The treatment initiation pack contains 4 cartons, each carton with 14 Lacosamide UCB film-coated tablets of 50 mg, 100 mg, 150 mg and 200 mg.
Croatian: Pakiranje za početak liječenja sadrži 4 kutije, svaka kutija s 14 filmom obloženih tableta od Lakozamid UCB 50 mg, 100 mg, 150 mg i 200 mg.
English: The precise volume of solution for infusion is to be calculated according to the exact body weight of the child.
Croatian: Točan volumen otopine za infuziju treba izračunati s obzirom na točnu tjelesnu težinu djeteta.
English: Atrial fibrillation or flutter were not reported in short term clinical trials; however, both have been reported in open-label epilepsy trials and in post-marketing experience.
Croatian: Fibrilacija ili undulacija atrija nisu zabilježene u kratkoročnim kliničkim istraživanjima; međutim oboje je zabilježeno u otvorenim istraživanjima epilepsije te tijekom razdoblja nakon stavljanja lijeka u promet.
English: In this study, 425 patients aged 16 to 70 years with uncontrolled partial-onset seizures taking stable doses of 1 or 2 marketed antiepileptic medicinal products were randomised to be converted to lacosamide monotherapy (either 400 mg/day or 300 mg/day in a 3:1 ratio).
Croatian: U tom je ispitivanju 425 bolesnika u dobi od 16 do 70 godina s nekontroliranim parcijalnim napadajima, koji su uzimali stabilne doze od 1 ili 2 antiepileptika dostupna na tržištu, randomizirano na prijelaz na monoterapiju lakozamidom (400 mg/dan ili 300 mg/dan u omjeru 3:1).
English: It is used to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation.
Croatian: • Koristi se za liječenje određenog oblika epilepsije karakteriziranog pojavom parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje.
English: Initiation of lacosamide treatment with a loading dose Lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen.
Croatian: Započinjanje liječenja lakozamidom udarnom dozom Liječenje lakozamidom može se također započeti pojedinačnom udarnom dozom od 200 mg, nakon čega otprilike nakon 12 sati slijedi režim doze održavanja od 100 mg dvaput na dan (200 mg/dan).
English: In these patients it should be considered to perform an ECG before a lacosamide dose increase above 400 mg/day and after lacosamide is titrated to steady-state.
Croatian: U ovih bolesnika treba razmotriti snimanje EKG-a prije povećanja doze lakozamida iznad 400 mg/dan i nakon što je lakozamid titriran do stanja dinamičke ravnoteže.
English: The efficacy supported by the extrapolation principle stated above was confirmed by a double-blind, randomised, placebo-controlled study.
Croatian: Djelotvornost potpomognuta gore navedenim principom ekstrapolacije potvrđena je u dvostruko slijepom, randomiziranom, placebom kontroliranom ispitivanju.
English: Psychotic disorder(1)
Croatian: Psihotični poremećaj(1)
English: The other ingredients are: sodium chloride, hydrochloric acid, water for injections.
Croatian: • Drugi sastojci su: natrijev klorid, kloridna kiselina, voda za injekciju.
English: Follow these steps the first time you take Lacosamide UCB:
Croatian: Slijedite ove korake pri prvoj uporabi lijeka Lakozamid UCB:
English: Lacosamide UCB 10 mg/ml solution for infusion is an alternative for patients when oral administration is temporarily not feasible.
Croatian: Lakozamid UCB 10 mg/ml otopina za infuziju alternativa je za bolesnike u kojih peroralna primjena privremeno nije moguća.
English: A total of 67.8 % of patients randomised to lacosamide and 58.1 % of patients randomised to placebo reported at least 1 adverse reaction.
Croatian: Ukupno je 67,8 % bolesnika randomiziranih na lakozamid i 58,1 % bolesnika randomiziranih na placebo prijavilo barem 1 nuspojavu.
English: The 6-month seizure freedom rates in elderly patients of 65 and above (62 patients in lacosamide, 57 patients in carbamazepine CR) were similar between both treatment groups.
Croatian: Stope bolesnika sa 6-mjesečnim razdobljem bez napadaja u starijih bolesnika u dobi od 65 godina i starijih (62 bolesnika liječena lakozamidom, 57 bolesnika liječenih karbamazepinom CR) bile su slične između obje liječene skupine.
English: Co-administration of warfarin with lacosamide does not result in a clinically relevant change in the pharmacokinetics and pharmacodynamics of warfarin.
Croatian: Istovremena primjena varfarina i lakozamida ne rezultira klinički značajnom promjenom u farmakokinetici i farmakodinamici varfarina.
English: PHARMACEUTICAL FORM AND CONTENTS 200 mg/20 ml
Croatian: OBLIK I SADRŽAJ 200 mg/20 ml
English: PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets.
Croatian: OBLIK I SADRŽAJ 56 filmom obloženih tableta.
English: Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
Croatian: Krvnim pretragama može se utvrditi jako smanjenje posebne skupine bijelih krvnih stanica (agranulocitoza);
English: Thoughts of harming or killing yourself or attempting suicide: tell your doctor straight away; Feeling angry or agitated;
Croatian: • misli o samoozljeđivanju ili samoubojstvu ili pokušaj samoubojstva: odmah se obratite liječniku;
English: Bradycardia(1,2) Atrial Fibrillation Atrial Flutter (1,2)
Croatian: Bradikardija(1,2) Fibrilacija atrija(1,2) Undulacija atrija(1,2)
English: A serious skin reaction which may include a high temperature and other flu-like symptoms, a rash on the face, extended rash, swollen glands (enlarged lymph nodes).
Croatian: • ozbiljna kožna reakcija koja može uključivati visoku tjelesnu temperaturu i druge simptome nalik gripi, osip po licu, osip koji se širi, otečene žlijezde (povećani limfni čvorovi).
English: The higher exposure was partly due to a reduced renal function in the studied subjects.
Croatian: Veća izloženost kod ispitanika bila je djelomično zbog smanjene funkcije bubrega.
English: Each ml of Lacosamide UCB syrup contains 187 mg sorbitol (E420), 2.60 mg sodium methyl parahydroxybenzoate (E219), 0.032 mg aspartame (E951), and 1.42 mg sodium.
Croatian: Jedan ml Lakozamid UCB sirupa sadrži 187 mg sorbitola (E420), 2,60 mg natrijeva metilparahidroksibenzoata (E219), 0,032 mg aspartama (E951) i 1,42 mg natrija.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX18 Mechanism of action
Croatian: Farmakoterapijska skupina: antiepileptici, ostali antiepileptici, ATK oznaka: N03AX18 Mehanizam djelovanja
English: The adjusted absolute difference between treatments was -1.3 % (95 % CI: -5.5, 2.8).
Croatian: Prilagođena apsolutna razlika između liječenja bila je -1,3 % (95% CI:5,5, 2,8).
English: Lacosamide is effectively removed from plasma by haemodialysis.
Croatian: Lakozamid se učinkovito uklanja iz plazme hemodijalizom.
English: Interaction trials showed that lacosamide had no effect on the pharmacokinetics of digoxin.
Croatian: Istraživanja interakcija pokazala su da lakozamid nije imao utjecaja na farmakokinetiku digoksina.
English: In juvenile dogs, transient and dose-related CNS clinical signs started to be observed at systemic exposure levels below the expected clinical exposure.
Croatian: U štenadi su se prolazni klinički simptomi SŽS-a povezani s dozom počeli pojavljivati pri razinama sistemske izloženosti nižim od očekivane kliničke izloženosti.
English: They will help you decide if you should take Lacosamide UCB or not.
Croatian: Liječnik će Vam pomoći u donošenju odluke trebate li uzimati Lakozamid UCB ili ne.
English: Lacosamide can also be initiated at the dose of 100 mg twice a day based on the physician's assessment of required seizure reduction versus potential side effects.
Croatian: Terapija lakozamidom također se može započeti dozom od 100 mg dvaput na dan na temelju ocjene liječnika za potrebnim smanjenjem napadaja u odnosu na potencijalne nuspojave.
English: Following twice daily dosing, steady state plasma concentrations are achieved after a 3 day period.
Croatian: 3 dana nakon doziranja dvaput dnevno postiže se stanje dinamičke ravnoteže koncentracije u plazmi.
English: In the placebo-controlled trials of lacosamide in epilepsy patients, atrial fibrillation or flutter were not reported; however, both have been reported in open-label epilepsy trials and in post-marketing experience.
Croatian: U placebom kontroliranim istraživanjima lakozamida u bolesnika s epilepsijom, fibrilacija ili undulacija atrija nisu zabilježene; međutim, oboje je zabilježeno u otvorenim istraživanjima epilepsije te tijekom razdoblja nakon stavljanja lijeka u promet.
English: In the repeated dose toxicity studies, mild reversible liver changes were observed in rats starting at about 3 times the clinical exposure.
Croatian: U ispitivanjima toksičnosti ponovljenih doza primijećene su blage reverzibilne promjene jetre kod štakora nakon izloženosti tri puta veće od kliničke izloženosti.
English: The carton boxes of Lacosamide UCB syrup contain a 30 ml measuring cup with graduation marks and a 10 ml oral syringe.
Croatian: Kartonske kutije Lakozamid UCB sirupa sadrže mjernu čašu od 30 ml s odmjernim oznakama i štrcaljku za usta od 10 ml.
English: Adolescents and children weighing 50 kg or more Dosage in adolescents and children weighing 50 kg or more is the same as in adults (see above).
Croatian: Adolescenti i djeca tjelesne težine 50 kg ili više Doziranje u adolescenata i djece tjelesne težine 50 kg ili više jednako je kao u odraslih (vidjeti gore).
English: Colourless type I glass vial with a chlorobutyl rubber closure coated with a fluoropolymer.
Croatian: I sa klorobutilnim gumenim zatvaračem obloženim fluoropolimerom.
English: Overall the proportion of subjects with a 50 % reduction in seizure frequency was 23 %, 34 %, and 40 % for placebo, lacosamide 200 mg/day and lacosamide 400 mg/day.
Croatian: Ukupni udio ispitanika s 50 % smanjenom frekvencijom parcijalnih napadaja bio je 23 % u skupini s placebom, 34 % u skupini s lakozamidom 200 mg/dan i 40 % u skupini s lakozamidom 400 mg/dan.