FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy of lacosamide as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine CR in 886 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Croatian: Djelotvornost lakozamida kao monoterapije ustanovljena je u dvostruko slijepom ispitivanju neinferiornosti na paralelnim skupinama u usporedbi s karbamazepinom CR u 886 bolesnika u dobi od 16 godina ili starijih s novo ili nedavno dijagnosticiranom epilepsijom.
English: Uncommon: may affect up to 1 in 100 children Feeling sleepy or lacking in energy (lethargy).
Croatian: Manje često: mogu se javiti u do 1 do 100 djece • osjećaju se pospano ili im nedostaje energije (letargija).
English: It is unknown whether the increased metabolite exposure in end-stage renal disease subjects could give rise to adverse effects but no pharmacological activity of the metabolite has been identified.
Croatian: Nije poznato može li povećana izloženost metabolitu kod ispitanika u završnom stadiju bubrežne bolesti uzrokovati povećanje nuspojava, no nije utvrđena farmakološka aktivnost metabolita.
English: Syncope(2) Coordination abnormal
Croatian: Sinkopa(2) Poremećaj koordinacije
English: In patients with proarrhythmic conditions, ventricular tachyarrhythmia has been reported.
Croatian: U bolesnika s proaritmijskim stanjima zabilježena je ventrikularna tahiaritmija.
English: PHARMACEUTICAL FORM Solution for infusion.
Croatian: OBLIK Otopina za infuziju.
English: There are no adequate data from the use of lacosamide in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni lakozamida kod trudnica.
English: The efficacy of lacosamide as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) was established in 3 multicenter, randomised, placebo-controlled clinical trials with a 12-week maintenance period.
Croatian: Djelotvornost lakozamida kao dodatne terapije u preporučenim dozama (200 mg/dan, 400 mg/dan) ustanovljena je u 3 multicentrična, randomizirana, placebom kontrolirana klinička ispitivanja u razdoblju održavanja od 12 tjedana.
English: you have severe heart disease such as heart failure or have had a heart attack.
Croatian: • ako bolujete od teške srčane bolesti kao što je zatajenje srca ili ste imali srčani udar.
English: The physician should prescribe the most appropriate formulation and strength according to weight and dose.
Croatian: Liječnik treba propisati najprikladniju formulaciju i jačinu u skladu s tjelesnom težinom i dozom.
English: Fatalities have been reported in patients following an intake of acute single overdose of several grams of lacosamide.
Croatian: Prijavljeni su smrtni ishodi kod bolesnika nakon akutnog jednokratnog predoziranja uzimanjem nekoliko grama lakozamida.
English: The most frequently reported adverse reactions (≥ 10 %) with lacosamide treatment were dizziness, headache, nausea and diplopia.
Croatian: Najčešće prijavljivane nuspojave (≥ 10 %) tijekom liječenja lakozamidom bile su omaglica, glavobolja, mučnina i diplopija.
English: It is therefore recommended to initiate treatment with the syrup and switch to tablets, if desired.
Croatian: Stoga se preporučuje početi liječenje sirupom te po želji prijeći na tablete.
English: Treatment of lacosamide overdose should include general supportive measures and may include haemodialysis if necessary (see section 5.2).
Croatian: Liječenje predoziranja lakozamidom treba uključivati opće potporne mjere i u slučaju potrebe može uključivati hemodijalizu (vidjeti dio 5.2).
English: Swallow the dose of syrup.
Croatian: 3. Progutajte dozu sirupa.
English: Administration of a loading dose has not been studied in acute conditions such as status epilepticus.
Croatian: Primjena udarne doze nije bila ispitivana u akutnim stanjima kao što je epileptički status (status epilepticus).
English: Lacosamide UCB syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria.
Croatian: Lakozamid UCB sirup sadrži aspartam (E951), izvor fenilalanina, koji može biti štetan u osoba s fenilketonurijom.
English: In treated patients who completed titration and started withdrawing antiepileptic medicinal products (284 and 99 respectively), monotherapy was maintained in 71.5 % and 70.7 % of patients respectively for 57-105 days (median 71 days), over the targeted observation period of 70 days.
Croatian: Kod liječenih bolesnika koji su završili s titracijom i započeli s ukidanjem drugih antiepileptika (284, odnosno 99), monoterapija je održana u 71,5 % odnosno 70,7 % bolesnika kroz 57-105 dana (medijan 71 dan), preko ciljanog razdoblja promatranja od 70 dana.
English: • A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Croatian: • jako rasprostranjen osip s mjehurima i ljuštenjem kože, posebice oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom) te teži oblik koji uzrokuje ljuštenje kože na više od 30 % površine tijela (toksična epidermalna nekroliza);
English: Caution is recommended in concomitant treatment with strong inhibitors of CYP2C9 (e.g. fluconazole) and CYP3A4 (e.g. itraconazole, ketoconazole, ritonavir, clarithromycin), which may lead to increased systemic exposure of lacosamide.
Croatian: Preporučuje se oprez pri istovremenom liječenju snažnim inhibitorima CYP2C9 (npr. flukonazol) i CYP3A4 (npr. itrakonazol, ketokonazol, ritonavir, klaritromicin), koje može izazvati povećanu sistemsku izloženost lakozamidu.
English: A loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted.
Croatian: Udarnom dozom može se započeti u bolesnika u situacijama kada liječnik odredi da je potrebno brzo postizanje koncentracija lakozamida u plazmi u stanju dinamičke ravnoteže i terapijskog učinka.
English: Do not stop taking Lacosamide UCB without talking to your doctor, as your epilepsy may come back again or become worse.
Croatian: • Ne prekidajte uzimanje lijeka Lakozamid UCB bez savjetovanja s liječnikom jer bi se epilepsija mogla ponovno pojaviti ili pogoršati.
English: See leaflet for further information.
Croatian: Vidjeti uputu o lijeku za daljnje informacije.
English: Fill the measuring cup to the millilitre (ml) dose marker prescribed by your doctor.
Croatian: Ispunite mjernu čašu do oznake za dozu u militrima (ml) koju je propisao Vaš liječnik.
English: The metabolism of lacosamide has not been completely characterised.
Croatian: Metabolizam lakozamida nije u potpunosti pojašnjen.
English: The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient.
Croatian: Možda će biti potrebna prilagodba doze uz pažljivo praćenje aktivnosti bolesti i mogućih nuspojava u bolesnika.
English: In comparison, plasma clearance was estimated at 1.92 L/h in adults (70 kg body weight).
Croatian: U usporedbi s tim, plazmatski klirens bio je procijenjen na 1,92 l/h u odraslih (70 kg tjelesne težine).
English: In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes.
Croatian: Elektrofiziološka ispitivanja in vitro pokazala su da lakozamid selektivno poboljšava sporu inaktivaciju natrijskih kanala reguliranih naponom, rezultat čega je stabilizacija hiperekscitabilnih membrana neurona.
English: How much to use
Croatian: Koliku dozu upotrijebiti
English: Erythema(4)
Croatian: Eritem(4)
English: Risk related to lacosamide
Croatian: Rizik povezan s lakozamidom
English: Adverse reactions associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur.
Croatian: Mogu se javiti nuspojave povezane s produljenjem PR-intervala (npr. atrioventrikularni blok, sinkopa, bradikardija).
English: Following oral administration, the plasma concentration of unchanged lacosamide increases rapidly and reaches Cmax about 0.5 to 4 hours post-dose.
Croatian: Koncentracija nepromijenjenog lakozamida u plazmi nakon peroralne primjene brzo raste i dostiže Cmax oko 0,5 do 4 sata nakon doziranja.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS) (1,2)
Croatian: Reakcija na lijek s eozinofilijom i sustavnim simptomima (DRESS) (1,2)
English: What Lacosamide UCB looks like and contents of the pack
Croatian: Kako Lakozamid UCB izgleda i sadržaj pakiranja
English: Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of lacosamide (approximately 50 % higher AUCnorm).
Croatian: Ispitanici s umjerenim oštećenjem jetre (Child-Pugh B) imali su veće koncentracije lakozamida u plazmi (oko 50 % veći AUCnorm).
English: Allergic reaction to medicine intake, hives;
Croatian: • alergijska reakcija na uzimanje lijeka, koprivnjača;
English: It is not recommended to take Lacosamide UCB if you are pregnant or breast-feeding, as the effects of Lacosamide UCB on pregnancy and the unborn baby or the new-born child are not known.
Croatian: Ne preporučuje se uzimanje lijeka Lakozamid UCB ako ste trudni ili dojite jer nisu poznati učinci lijeka Lakozamid UCB na trudnoću i na plod ili novorođenče.
English: 6.1 List of excipients water for injections sodium chloride hydrochloric acid (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari voda za injekcije natrijev klorid kloridna kiselina (za podešavanje pH)
English: Wash the oral syringe with water only (figure 13).
Croatian: • Isperite štrcaljku za usta samo vodom (slika 13).
English: Solution for infusion is an alternative for patients when oral administration is temporarily not feasible.
Croatian: Otopina za infuziju predstavlja alternativu za bolesnike kod kojih peroralna primjena privremeno nije moguća.
English: Lacosamide should be administered to adult and paediatric patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks.
Croatian: U odraslih i pedijatrijskih bolesnika s teškim oštećenjem jetre lakozamid treba primjenjivati samo kada se predviđa da očekivana korist od liječenja nadilazi moguće rizike.
English: Lacosamide UCB with alcohol As a safety precaution do not take Lacosamide UCB with alcohol.
Croatian: Lakozamid UCB s alkoholom Kao sigurnosnu mjeru opreza ne uzimajte Lakozamid UCB s alkoholom.
English: Lacosamide UCB may make you dizzy - this could increase the risk of accidental injury or a fall.
Croatian: Lakozamid UCB može kod Vas izazvati omaglicu - to može povećati rizik od slučajne ozljede ili pada.
English: Nystagmus Hypoesthesia Dysarthria Disturbance in attention
Croatian: Nistagmus Hipoestezija Dizartrija Poremećaj pažnje Parestezija
English: What Lacosamide UCB is and what it is used for
Croatian: Što je Lakozamid UCB i za što se koristi
English: Each vial of Lacosamide UCB solution for infusion must be used only once (single use).
Croatian: Svaka bočica Lakozamid UCB otopine za infuziju smije se upotrijebiti samo jednom (jednokratna uporaba).
English: If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time.
Croatian: Ako propusti uzeti dozu, bolesnika treba uputiti da odmah uzme propuštenu dozu lijeka i da zatim uzme sljedeću dozu lakozamida u uobičajeno vrijeme uzimanja.
English: In the elderly population, the maintenance lacosamide dose was 200 mg/day in 55 patients (88.7 %), 400 mg/day in 6 patients (9.7 %) and the dose was escalated to over 400 mg/day in 1 patient (1.6 %).
Croatian: U starijoj populaciji, doza održavanja lakozamida bila je 200 mg/dan u 55 bolesnika (88,7 %), 400 mg/dan u 6 bolesnika (9,7 %) i doza je u jednog bolesnika (1,6 %) bila povećana na više od 400 mg/dan.
English: Abnormal thinking or losing of touch with reality;
Croatian: • neuobičajeno razmišljanje ili gubitak veze sa stvarnošću;
English: Hepatic enzyme increased (> 2x ULN) (1)
Croatian: Povišene vrijednosti jetrenih enzima (> 2x GGN)(1)
English: Double vision (diplopia).
Croatian: • dvoslike (diplopija).
English: Pull the piston down to fill the oral syringe with a small amount of solution (figure 6).
Croatian: • Povucite klip prema dolje da biste štrcaljku za usta napunili malom količinom otopine (slika 6).
English: In a study in elderly men and women including 4 patients > 75 years of age, AUC was about 30 and 50 % increased compared to young men, respectively.
Croatian: U ispitivanju sa starijim muškarcima i ženama, uključujući 4 bolesnika starija od 75 godina života, AUC je bio veći za oko 30, odnosno 50 % nego kod mladih muškaraca.
English: Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Croatian: • problemi s održavanjem ravnoteže, drhtanje (tremor), trnci (parestezija) ili grčevi mišića, lako padanje i zadobivanje modrica;
English: SPECIAL STORAGE CONDITIONS Do not refrigerate.
Croatian: POSEBNE MJERE ČUVANJA Ne odlagati u hladnjak.
English: The elimination half-life of lacosamide is approximately 13 hours.
Croatian: Poluvrijeme eliminacije lakozamida je približno 13 sati.
English: Atrioventricular block(1,2)
Croatian: Atrioventrikularni blok(1,2)
English: An infusion duration of at least 30 minutes for administration > 200 mg per infusion (i.e. > 400 mg/day) is preferred.
Croatian: Poželjno je trajanje infuzije od najmanje 30 minuta za primjenu > 200 mg po infuziji (npr. > 400 mg/dan).
English: If you take more than 12.5 ml of syrup each day and are on a controlled sodium diet, take this into consideration.
Croatian: Ako uzimate više od 12,5 ml sirupa svakog dana i ako ste na ograničenom unosu natrija, morate to uzeti u obzir.
English: Subjects were to remain on stable lacosamide dose throughout the maintenance period or were withdrawn and entered in the blinded taper period.
Croatian: Ispitanici su ostali na stabilnoj dozi lakozamida kroz cijelo razdoblje održavanja ili su povučeni iz ispitivanja i ušli u slijepo razdoblje postupnog smanjenja doze.
English: Following a 4-hour haemodialysis treatment, AUC of lacosamide is reduced by approximately 50 %.
Croatian: Nakon 4-satne hemodijalize AUC lakozamida smanjio se za oko 50 %.
English: The pharmacokinetics is dose-proportional and constant over time, with low intra- and inter-subject variability.
Croatian: Farmakokinetika je proporcionalna dozi i konstantna tijekom vremena s malim varijacijama kod svakog ispitanika i među njima.
English: How much to take
Croatian: Koliku dozu uzeti
English: The pharmacokinetics and safety of a single loading dose of intravenous lacosamide were determined in a multicenter, open-label study designed to assess the safety and tolerability of rapid initiation of lacosamide using a single intravenous loading dose (including 200 mg) followed by twice daily oral dosing (equivalent to the intravenous dose) as adjunctive therapy in adult subjects 16 to 60 years of age with partial-onset seizures.
Croatian: Farmakokinetika i sigurnost jednokratne udarne doze intravenskog lakozamida utvrđena je u multicentričnom otvorenom ispitivanju dizajniranom za ocjenu sigurnosti i podnošljivosti brzog uvođenja lakozamida koristeći jednokratnu intravensku udarnu dozu (koja uključuje 200 mg) nakon koje slijedi oralno doziranje dvaput dnevno (ekvivalentno intravenskoj dozi) kao dodatna terapija u odraslih ispitanika u dobi od 16 do 60 godina s parcijalnim napadajima.
English: If you take more than 3 graduation marks of syrup each day and are on a controlled sodium diet, take this into consideration.
Croatian: Ako uzimate više od tri odmjerne oznake sirupa svakog dana i ako ste na ograničenom unosu natrija, morate to uzeti u obzir.
English: In patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy below should be followed.
Croatian: U bolesnika koji su dosegli dozu veću od 400 mg/dan i koji trebaju dodatni antiepileptički lijek, treba slijediti preporučeno doziranje za dodatnu terapiju.
English: In vitro studies indicate that the enzymes CYP1A2, CYP2B6, and CYP2C9 are not induced and that CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6, and CYP2E1 are not inhibited by lacosamide at plasma concentrations observed in clinical trials.
Croatian: Ispitivanja in vitro ukazuju da enzimi CYP1A2, CYP2B6 i CYP2C9 nisu inducirani te da CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6 i CYP2E1 nisu inhibirani lakozamidom pri koncentracijama u plazmi dosegnutim tijekom kliničkih istraživanja.
English: After oral and intravenous administration of radiolabeled lacosamide, approximately 95 % of radioactivity administered was recovered in the urine and less than 0.5 % in the faeces.
Croatian: Nakon peroralne i intravenske primjene radioaktivno obilježenog lakozamida u mokraći je nađeno oko 95 % primijenjene radioaktivnosti, a u fecesu manje od 0,5 %.
English: Lacosamide UCB can be started by: - taking the medicine by mouth or - by being given as an intravenous infusion (sometimes called an “IV infusion”) where the medicine is given into your vein by a doctor or nurse.
Croatian: • Primjenu lijeka Lakozamid UCB moguće je započeti: - uzimanjem lijeka kroz usta ili - davanjem lijeka u obliku intravenske infuzije (koja se ponekad naziva „i.v. infuzija“), pri čemu Vam lijek u venu primjenjuje liječnik ili medicinska sestra / medicinski tehničar.
English: Lacosamide UCB is available in packs of 14, 28, 56, 14 x 1 and 56 x 1 film-coated tablets and in multipacks comprising 3 cartons, each containing 56 tablets.
Croatian: Lakozamid UCB je dostupan u pakiranjima od 14, 28, 56, 14 x 1 i 56 x 1 filmom obloženih tableta i u višestrukim pakiranjima koja se sastoje od 3 kutije od kojih svaka sadrži 56 tableta.
English: The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a functionalised amino acid.
Croatian: Djelatna tvar, lakozamid (R-2-acetamido-N-benzil-3-metoksipropionamid) funkcionalna je aminokiselina.
English: Treatment with lacosamide has been associated with dizziness which could increase the occurrence of accidental injury or falls.
Croatian: Liječenje lakozamidom povezano je s pojavom omaglice, što može povećati pojavu slučajnog ozljeđivanja ili padanja.
English: You will start your treatment with a low dose of Lacosamide UCB, usually 50 mg twice a day, and increase it week by week.
Croatian: Vaše liječenje ćete započeti niskom dozom lijeka Lakozamid UCB, obično 50 mg dvaput na dan, i povećavati je iz tjedna u tjedan.
English: Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
Croatian: • usporeni otkucaji srca, osjećaj lupanja srca, nepravilan puls ili druge promjene električne aktivnosti srca (poremećaji provođenja);
English: PVC/PVDC blister sealed with an aluminium foil.
Croatian: PVC/PVDC blister, zatvoren aluminijskom folijom.
English: In the monotherapy study comparing lacosamide to carbamazepine CR, the types of adverse reactions related to lacosamide in elderly patients (≥ 65 years of age) appear to be similar to that observed in patients less than 65 years of age.
Croatian: U ispitivanju monoterapije u kojem je lakozamid uspoređivan s karbamazepinom CR, čini se da su vrste nuspojava povezane s lakozamidom u starijih bolesnika (≥ 65 godina starosti) bile slične onima opaženim kod bolesnika mlađih od 65 godina.
English: When you take Lacosamide UCB with other antiepileptic medicines - Start of the treatment (the first 4 weeks)
Croatian: Kad uzimate Lakozamid UCB s drugim antepileptičkim lijekovima Početak liječenja (prva 4 tjedna)
English: In absence of haemodialysis in patients with end-stage renal disease, the levels were increased and continuously rising during the 24-hour sampling.
Croatian: Kod nehemodijaliziranih bolesnika sa završnim stadijem bubrežne bolesti razine su bile povećane i kontinuirano su rasle tijekom 24-satnog uzorkovanja.
English: No adverse reactions on male or female fertility or reproduction were observed in rats at doses producing plasma exposures (AUC) up to approximately 2 times the plasma AUC in humans at the maximum recommended human dose (MRHD).
Croatian: U ženki i mužjaka štakora nisu primijećene nuspojave povezane s plodnošću ili reprodukcijom pri dozama koje uzrokuju plazmatsku izloženost (AUC) do približno 2 puta veće od plazmatske AUC pri najvišoj preporučenoj dozi u ljudi.
English: In rare cases, these events have led to asystole, cardiac arrest and death in patients with underlying proarrhythmic conditions.
Croatian: U rijetkim slučajevima, ovi su događaji u bolesnika s podležećim proaritmijskim stanjima doveli do asistolije, srčanog zastoja i smrti.
English: Statistically significant (p=0.0003) and clinically relevant reduction in partial-onset seizure frequency per 28 days from baseline to the maintenance period was observed between the lacosamide and the placebo group.
Croatian: Statistički značajno (p=0,0003) i klinički relevantno smanjenje djelomičnih pojava učestalosti napadaja od 28 dana od početne točke do razdoblja održavanja uočeno je između skupina koje su primale placebo i lakozamid.
English: Nervous system side effects such as dizziness may be higher after a single “loading” dose.
Croatian: Nuspojave središnjeg živčanog sustava kao što je omaglica mogu biti pojačane nakon jednokratne „udarne“ doze.
English: These reactions are variable in expression, but typically present with fever and rash and can be associated with involvement of different organ systems.
Croatian: Te reakcije imaju različite kliničke slike, no u pravilu se očituju vrućicom i osipom i mogu biti povezane sa zahvaćenošću različitih organskih sustava.
English: 5 x 20 ml solution for infusion
Croatian: 5x20 ml otopina za infuziju
English: The efficacy and safety of lacosamide in conversion to monotherapy has been assessed in a historicalcontrolled, multicentre, double-blind, randomised trial.
Croatian: Djelotvornost i sigurnost lakozamida kod prijelaza na monoterapiju ocjenjivane su u povijesno kontroliranom, multicentričnom, dvostruko slijepom, randomiziranom ispitivanju.
English: The patients were randomised to carbamazepine CR or lacosamide, provided as tablets, in a 1:1 ratio.
Croatian: Bolesnici su bili randomizirani na karbamazepin CR ili lakozamid, u obliku tableta, u omjeru 1:1.
English: There was no clinically relevant interaction between lacosamide and metformin.
Croatian: Nije bilo klinički značajne interakcije između lakozamida i metformina.
English: Your doctor will work out the right dose for you:
Croatian: Vaš će liječnik odrediti odgovarajuću dozu:
English: Depending on response and tolerability, Lacosamide UCB 150 mg tablets may be taken twice a day during the third week and Lacosamide UCB 200 mg tablets twice a day during the fourth week.
Croatian: Ovisno o odgovoru i podnošljivosti, Lakozamid UCB tablete od 150 mg mogu se uzimati dvaput na dan tijekom trećeg tjedna i Lakozamid UCB tablete od 200 mg dvaput na dan tijekom četvrtog tjedna.
English: Population pharmacokinetic analyses in different age groups estimated that concomitant treatment with other antiepileptic medicinal products known to be enzyme inducers (carbamazepine, phenytoin, phenobarbital, in various doses) decreased the overall systemic exposure of lacosamide by 25 % in adults and 17 % in paediatric patients.
Croatian: Populacijskom farmakokinetičkom analizom u različitim dobnim skupinama procijenjeno je da je istovremenom primjenom s drugim antiepileptičkim lijekovima koji induciraju enzime (karbamazepin, fenitoin, fenobarbital, u različitim dozama) smanjena ukupna sistemska izloženost lakozamidu za 25 % u odraslih i 17 % u pedijatrijskih bolesnika.
English: The exposure of the O-desmethyl metabolite was several-fold increased in patients with moderate and severe renal impairment.
Croatian: Izloženost O-dezmetilnom metabolitu nekoliko je puta veća kod bolesnika s umjerenim i teškim oštećenjem bubrega.
English: Administration of a loading dose has not been studied in children.
Croatian: Primjena udarne doze nije ispitana u djece.