FrancophonIA/ELRC3.0 huggingface dataset:
English: In all of these controlled studies, the discontinuation rate due to adverse reactions was 12.2 % for patients randomised to lacosamide and 1.6 % for patients randomised to placebo.
Croatian: U svim navedenim kontroliranim ispitivanjima, stopa prekidanja liječenja zbog nuspojava bila je 12,2 % kod bolesnika randomiziranih na lakozamid i 1,6 % kod bolesnika randomiziranih na placebo.
English: Lacosamide UCB is used in adults, adolescents and children aged 4 years and older.
Croatian: • Lakozamid UCB se koristi u odraslih, adolescenata i djece od navršenih 4 godine života.
English: The AUC of lacosamide was increased by approximately 30 % in mildly and moderately and 60 % in severely renal impaired patients and patients with end-stage renal disease requiring haemodialysis compared to healthy subjects, whereas Cmax was unaffected.
Croatian: AUC lakozamida bio je, u usporedbi sa zdravim ispitanicima, povećan za oko 30 % u bolesnika sa blagim i umjerenim oštećenjem bubrega te za 60 % u bolesnika s teškim oštećenjem bubrega i u bolesnika sa završnim stadijem bubrežne bolesti koji zahtijevaju hemodijalizu, dok je Cmax bio nepromijenjen.
English: Do not take Lacosamide UCB if any of the above applies to you.
Croatian: Nemojte uzimati Lakozamid UCB ako se na Vas odnosi bilo koja od gornjih tvrdnji.
English: Nausea Vomiting Constipation Flatulence
Croatian: Mučnina Povraćanje Konstipacija
English: Take Lacosamide UCB twice each day - once in the morning and once in the evening.
Croatian: • Primjenjujte Lakozamid UCB dvaput na dan - jednom ujutro i jednom navečer.
English: Lacosamide UCB solution for infusion was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in glass or PVC bags at temperatures up to 25°C.
Croatian: Za Lakozamid UCB otopinu za infuziju se pokazalo da je fizikalno kompatibilna i kemijski stabilna kada se miješa sa sljedećim otopinama za razrjeđivanje kroz barem 24 sata i kada se čuva u staklu ili PVC vrećama na temperaturama do 25°C.
English: Push the piston up to get rid of any bubbles (figure 7).
Croatian: • Gurnite klip prema gore da uklonite mjehuriće (slika 7).
English: However, cases with second- and third-degree AV Block associated with lacosamide treatment have been reported in post-marketing experience.
Croatian: Međutim, slučajevi pojave AV-bloka drugog i trećeg stupnja povezani s liječenjem lakozamidom zabilježeni su tijekom razdoblja nakon stavljanja lijeka u promet.
English: In adjunctive clinical trials in epilepsy patients the incidence rate of reported first-degree AV Block is uncommon, 0.7 %, 0 %, 0.5 % and 0 % for lacosamide 200 mg, 400 mg, 600 mg or placebo, respectively.
Croatian: U dodatnim kliničkim istraživanjima u bolesnika s epilepsijom stopa incidencije prijavljenih AVblokova prvog stupnja manje je česta te iznosi 0,7 %, 0 %, 0,5 % za lakozamid u dozi od 200 mg, 400 mg, 600 mg odnosno 0 % za placebo.
English: A slightly viscous clear, colourless to yellow-brown liquid.
Croatian: Blago viskozna, bistra, bezbojna do žutosmeđa tekućina.
English: Contains sorbitol (E420), sodium methyl parahydroxybenzoate (E219), aspartame (E951), and sodium.
Croatian: Sadrži sorbitol (E420), natrijev metilparahidroksibenzoat (E219), aspartam (E951) i natrij.
English: Instructions for use: oral syringe
Croatian: Upute za uporabu: štrcaljka za usta
English: Turn the bottle upside down (figure 5).
Croatian: • Okrenite bocu naopako (slika 5).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za jednokratnu uporabu.
English: PHARMACEUTICAL FORM AND CONTENTS 1 x 20 ml solution for infusion 200 mg/20 ml
Croatian: OBLIK I SADRŽAJ 1x20 ml otopina za infuziju 200 mg/20 ml
English: 200 mg tablet: indigo carmine aluminium lake (E132).
Croatian: 200 mg tableta: indigo carmine aluminium lake (E132)
English: Based on the analysis of pooled placebo-controlled clinical trials in adjunctive therapy in 1,308 patients with partial-onset seizures, a total of 61.9 % of patients randomised to lacosamide and 35.2 % of patients randomised to placebo reported at least 1 adverse reaction.
Croatian: Na temelju analize udruženih placebom kontroliranih kliničkih istraživanja u dodatnoj terapiji u 1308 bolesnika s parcijalnim napadajima, ukupno 61,9 % bolesnika koji su randomizirani na lakozamid i 35,2 % bolesnika koji su randomizirani na placebo prijavilo je barem jednu nuspojavu.
English: Taking Lacosamide UCB on its own - This is for information only.
Croatian: Kada se uzima samo Lakozamid UCB- ovo je samo informativno.
English: Lacosamide may be taken with or without food.
Croatian: Lakozamid se može uzeti sa ili bez hrane.
English: The recommended starting dose is 2 mg/kg/day which should be increased to an initial therapeutic dose of 4 mg/kg/day after one week.
Croatian: Preporučena početna doza je 2 mg/kg/dan, koju nakon tjedan dana treba povećati na početnu terapijsku dozu od 4 mg/kg/dan.
English: In anesthetised dogs and Cynomolgus monkeys, at intravenous doses of 15-60 mg/kg, slowing of atrial and ventricular conductivity, atrioventricular block and atrioventricular dissociation were seen.
Croatian: Nakon intravenskih doza od 15 do 60 mg/kg anesteziranim psima i makaki majmunima primijećeni su usporeno provođenje impulsa kroz atrij i ventrikul te atrioventrikularni blok i atrioventrikularna disocijacija.
English: This was reported with lacosamide in 4.8 % (3/62) in elderly patients versus 1.6 % (6/382) in younger adult patients.
Croatian: Kod primjene lakozamida on je prijavljen u 4,8 % (3/62) starijih bolesnika naspram 1,6 % (6/382) u mlađih odraslih bolesnika.
English: No second- or higher degree AV Block was seen in these studies.
Croatian: U tim ispitivanjima nije zabilježena pojava AV-bloka drugog ili višeg stupnja.
English: The dose titration in these patients should be performed with caution considering co-existing renal impairment.
Croatian: Titriranje doze u tih bolesnika mora se obaviti s oprezom uzimajući u obzir moguće istovremeno oštećenje bubrega.
English: No dose reduction is necessary in elderly patients.
Croatian: Kod starijih bolesnika ne treba smanjivati dozu.
English: In an interaction trial there was no clinically relevant interaction between lacosamide and the oral contraceptives ethinylestradiol and levonorgestrel.
Croatian: U istraživanju interakcija nije bilo klinički značajne interakcije između lakozamida i oralnih kontraceptiva etinilestradiola i levonorgestrela.
English: This medicinal product contains 2.6 mmol (or 59.8 mg) sodium per vial.
Croatian: Ovaj lijek sadrži 2,6 mmol (ili 59,8 mg) natrija po bočici.
English: Any unused solution should be discarded.
Croatian: Svu neiskorištenu otopinu potrebno je zbrinuti.
English: An in vitro study indicated that lacosamide is not transported by P-glycoprotein in the intestine.
Croatian: Ispitivanje in vitro pokazalo je da se lakozamid ne prenosi P-glikoproteinom u crijevima.
English: In children weighing from 20 to under 30 kg, a maximum dose of 10 mg/kg/day is recommended and in children weighing from 30 to under 50 kg a maximum dose of 8 mg/kg/day is recommended, although in open-label studies (see sections 4.8 and 5.2), a dose up to 12 mg/kg/day has been used by a small number of these children.
Croatian: U djece tjelesne težine od 20 do manje od 30 kg preporučena je maksimalna doza od 10 mg/kg/dan, a u djece tjelesne težine od 30 do manje od 50 kg preporučena je maksimalna doza od 8 mg/kg/dan, iako je u otvorenim ispitivanjima (vidjeti dijelove 4.8 i 5.2) doza do 12 mg/kg/dan primijenjena na malom broju te djece.
English: Age associated decreased renal clearance with an increase in AUC levels should be considered in elderly patients (see following paragraph ‘renal impairment' and section 5.2).
Croatian: Kod starijih bolesnika treba uzeti u obzir smanjenje bubrežnog klirensa povezanog s dobi i povećanje razina AUC-a (vidjeti sljedeći odlomak „oštećenje bubrega“ i dio 5.2).
English: Lacosamide UCB is available in a bottle of 200 ml.
Croatian: • Lakozamid UCB je dostupan u bocama od 200 ml.
English: Trouble with your memory, thinking or finding words, confusion;
Croatian: • problemi s pamćenjem, poteškoće u razmišljanju ili odabiru riječi, smetenost;
English: What Lacosamide UCB is and what it is used for What you need to know before you take Lacosamide UCB How to take Lacosamide UCB Possible side effects
Croatian: Što je Lakozamid UCB i za što se koristi Što morate znati prije nego počnete uzimati Lakozamid UCB Kako uzimati Lakozamid UCB Moguće nuspojave
English: The administered lacosamide doses ranged from 2 to 17.8 mg/kg/day in twice daily intake, with a maximum of 600 mg/day for children weighing 50 kg or more.
Croatian: Doze lakozamida davane su u rasponu od 2 do 17,8 mg/kg/dan dvaput na dan, s maksimalnom dozom od 600 mg/dan za djecu tjelesne težine od 50 kg ili više.
English: LIST OF EXCIPIENTS Contains sodium chloride, hydrochloric acid, water for injections.
Croatian: POPIS POMOĆNIH TVARI Sadrži natrijev klorid, kloridnu kiselinu, vodu za injekcije.
English: If a loading dose is indicated, an initial dose of 100 mg followed by a 50 mg twice daily regimen for the first week should be used.
Croatian: Ako je indicirana udarna doza, treba koristiti inicijalnu dozu od 100 mg nakon koje slijedi režim doziranja od 50 mg dvaput dnevno u prvom tjednu.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 168 (3 packs of 56) film-coated tablets
Croatian: OBLIK I SADRŽAJ Višestruko pakiranje: 168 (3 pakiranja od 56) filmom obloženih tableta
English: (4) Local adverse reactions associated with intravenous administration.
Croatian: (3) Prijavljeno u otvorenim ispitivanjima. (4)Lokalne nuspojave povezane s intravenskom primjenom.
English: Monitor closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (e.g. myocardial ischemia, heart failure) when lacosamide dose is higher than 400 mg/day (see Method of administration below and section 4.4).
Croatian: Potrebno je pažljivo nadzirati bolesnike s poznatim smetnjama srčane provodljivosti, koji su na istodobnoj terapiji s lijekovima koji produljuju PR interval ili teškom srčanom bolesti (npr. ishemija miokarda, zatajenje srca), kada je doza lakozamida veća od 400 mg /dan (vidjeti Način primjene niže i dio 4.4).
English: In this type of epilepsy, fits first affect only one side of your brain.
Croatian: • U tom obliku epilepsije napadaji prvo zahvaćaju samo jednu stranu mozga, ali se nakon toga mogu proširiti i na veća područja zahvaćajući pritom obje strane mozga.
English: Turn the bottle the right way up (figure 9).
Croatian: • Okrenite bocu u uspravan položaj (slika 9).
English: Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Croatian: Lakozamid UCB je indiciran kao monoterapija i dodatna terapija u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata i djece od navršenih 4 godine života s epilepsijom.
English: If you are taking Lacosamide UCB and you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek medical advice immediately (see section 4).
Croatian: Ako tijekom uzimanja lijeka Lakozamid UCB primijetite simptome poremećaja otkucaja srca (kao što su usporeni, ubrzani ili nepravilni otkucaji srca, osjećaj lupanja srca, nedostatak zraka, osjećaj ošamućenosti, nesvjestica), odmah potražite liječničku pomoć (pogledajte dio 4).
English: Maximum recommended dose up to 600 mg/day up to 400 mg/day
Croatian: Maksimalna preporučena doza do 600 mg/dan do 400 mg/dan
English: Lacosamide should be used with caution in patients treated with medicinal products known to be associated with PR prolongation (including sodium channel blocking antiepileptic medicinal products) and in patients treated with antiarrhythmics.
Croatian: Lakozamid treba primjenjivati s oprezom kod bolesnika liječenih lijekovima za koje se zna da produljuju PR-interval (uključujući antiepileptičke lijekove koji blokiraju natrijske kanale) te kod bolesnika liječenih antiaritmicima.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C for product mixed with the diluents mentioned in 6.6 and stored in glass or PVC bags.
Croatian: Kemijska i fizikalna stabilnost u primjeni dokazana je tijekom 24 sata na temperaturama do 25°C za lijek pomiješan s otopinama za razrjeđivanje navedenim u 6.6 i čuvanim u staklu ili PVC vrećama.
English: The decrease in non-renal clearance in the patients of the study was estimated to give a 20 % increase in the AUC of lacosamide.
Croatian: Procijenjeno je da smanjenje nebubrežnog klirensa kod bolesnika u ispitivanju povećava AUC lakozamida za 20 %.
English: Children and adolescent weighing less than 50 kg The dose depends on their body weight.
Croatian: Djeca i adolescenti tjelesne težine manje od 50 kg Doza ovisi o njihovoj tjelesnoj težini.
English: Conversion to monotherapy
Croatian: Prijelaz na monoterapiju
English: Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
Croatian: Krvnim pretragama mogu se utvrditi povišene razine jetrenih enzima i jedne vrste bijelih krvnih stanica (eozinofilija);
English: If you forget to take Lacosamide UCB
Croatian: Ako ste zaboravili uzeti Lakozamid UCB
English: Depending on response and tolerability, the maintenance dose can be further increased by 2 mg/kg/day every week.
Croatian: Ovisno o odgovoru i podnošljivosti, doza održavanja se svakih tjedan dana može dalje povećavati za 2 mg/kg/dan.
English: 0.2 ml/kg 0.3 ml/kg 0.4 ml/kg 0.5 ml/kg Maximum recommended dose: 0.6 ml/kg
Croatian: 0,2 ml/kg 0,3 ml/kg 0,4 ml/kg 0,5 ml/kg Maksimalna preporučena doza: 0,6 ml/kg
English: Lacosamide syrup is provided with a measuring cup with graduation marks (for patients weighing 50 kg or more) and with an oral syringe with an adaptor (for patients weighing less than 50 kg).
Croatian: Lakozamid sirup isporučuje se s mjernom čašom s odmjernim oznakama (za bolesnike tjelesne težine 50 kg ili više) i sa štrcaljkom za usta s nastavkom (za bolesnike tjelesne težine manje od 50 kg).
English: During the titration period, lacosamide doses were adjusted in 1or 2 mg/kg/day increments in subjects weighing less than 50 kg or 50 or 100 mg/day in subjects weighing 50 kg or more at weekly intervals to achieve the target maintenance period dose range.
Croatian: Tijekom razdoblja titracije, doze lakozamida prilagođene su u povećanjima od 1 ili 2 mg/kg/dnevno u ispitanika s tjelesnom težinom manjom od 50 kg ili 50 ili 100 mg/dnevno u ispitanika s tjelesnom težinom od 50 kg ili većom u tjednim intervalima kako bi se postigao ciljani raspon doze u razdoblju održavanja.
English: Other medicines and Lacosamide UCB
Croatian: Drugi lijekovi i Lakozamid UCB
English: The maximum recommended dose is 400 mg/day.
Croatian: Maksimalna je preporučena doza 400 mg/dan.
English: Treatment initiation pack
Croatian: Pakiranje za početak liječenja
English: The CYP2C19 inhibitor omeprazole (40 mg once daily) did not give rise to a clinically significant change in lacosamide exposure.
Croatian: Omeprazol (40 mg jednom na dan), koji je inhibitor CYP2C19, nije prouzročio klinički značajnu promjenu izloženosti lakozamidu.
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Croatian: Ako niste sigurni u to, obratite se svom liječniku ili ljekarniku prije nego uzmete ovaj lijek.
English: The typical plasma clearance was estimated to be 1.04 L/h, 1.32 L/h and 1.86 L/h for children weighing 20 kg, 30 kg and 50 kg respectively.
Croatian: Tipični plazmatski klirens bio je procijenjen na 1,04 l/h, 1,32 l/h i 1.86 l/h za djecu tjelesne težine od 20 kg, 30 kg i 50 kg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING TREATMENT INITIATION PACK ONLY Outer carton - treatment initiation pack containing 4 cartons of 14 film-coated tablets
Croatian: LIJEČENJA Vanjska kutija - pakiranje za početak liječenja koje sadrži 4 kutije s 14 filmom obloženih tableta
English: The patients had to present with unprovoked partial-onset seizures with or without secondary generalisation.
Croatian: Bolesnici su morali imati spontane parcijalne napadaje sa sekundarnom generalizacijom ili bez nje.
English: Uncommon: may affect up to 1 in 100 people Injection site redness.
Croatian: Manje često: mogu se javiti u do 1 na 100 osoba • crvenilo na mjestu injekcije.
English: PHARMACEUTICAL FORM AND CONTENTS 200 ml syrup with measuring cup and oral syringe
Croatian: OBLIK I SADRŽAJ 200 ml sirup s mjernom čašom i štrcaljkom za usta
English: Put the adaptor into the top of the bottle (figure 3).
Croatian: • Postavite nastavak na vrh boce (slika 3).
English: During the second week, the patient takes Lacosamide UCB 100 mg tablets twice a day.
Croatian: Tijekom drugog tjedna bolesnik uzima Lakozamid UCB tabletu 100 mg dvaput na dan.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister label
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister
English: Lacosamide did not affect the pharmacokinetics of omeprazole (metabolised by CYP2C19 and CYP3A4, lacosamide given 300 mg twice a day).
Croatian: Lakozamid nije utjecao na farmakokinetiku omeprazola (metabolizira ga CYP2C19 i CYP3A4, lakozamid dan 300 mg dvaput na dan).
English: Lacosamide UCB tablets and oral syrup are bioequivalent.
Croatian: Lakozamid UCB tablete i oralni sirup su bioekvivalentni.
English: Do not drive, cycle or use any tools or machines until you know how this medicine affects you.
Croatian: Nemojte voziti automobil ili bicikl, niti koristiti alate ili strojeve dok ne znate kako ovaj lijek utječe na Vas jer Lakozamid UCB može uzrokovati omaglicu ili zamućen vid.
English: The Kaplan-Meier estimates of 12-month seizure freedom rates were 77.8 % for lacosamide-treated patients and 82.7 % for carbamazepine CR treated patients.
Croatian: Procjene stopa bolesnika s 12-mjesečnim razdobljem bez napadaja po Kaplan-Meierovoj metodi bile su 77,8 % za bolesnike liječene lakozamidom i 82,7 % za bolesnike liječene karbamazepinom CR.
English: Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) Lacosamide UCB 50 mg film-coated tablets
Croatian: Pakiranje za početak liječenja (samo za adolescente i djecu tjelesne težine veće od 50 kg, te odrasle) Lakozamid UCB 50 mg filmom obložene tablete
English: Thus, moderate inhibitors of CYP2C19 are unlikely to affect systemic lacosamide exposure to a clinically relevant extent.
Croatian: Stoga nije vjerojatno da će primjena umjerenog inhibitora CYP2C19 klinički značajno utjecati na sistemsku izloženost lakozamidu.
English: If your doctor decides to stop your treatment with Lacosamide UCB, they will tell you how to decrease the dose step by step.
Croatian: • Ako liječnik odluči prekinuti Vaše liječenje lijekom Lakozamid UCB, dat će Vam upute kako postupno smanjivati dozu.
English: Measuring cup (for adolescents and children weighing 50 kg or more, and adults) Each graduation mark (5 ml) of the measuring cup corresponds to 50 mg lacosamide.
Croatian: Mjerna čaša (za adolescente i djecu tjelesne težine 50 kg ili više, te odrasle) Svaka odmjerna oznaka (5 ml) mjerne čaše odgovara 50 mg lakozamida.
English: Lacosamide UCB syrup contains sodium methyl parahydroxybenzoate (E219), which may cause allergic reactions (possibly delayed).
Croatian: Pomoćne tvari koje mogu uzrokovati nepodnošenje Lakozamid UCB sirup sadrži natrijev metilparahidroksibenzoat (E219) koji može uzrokovati alergijske reakcije (moguće i odgođene).
English: Children (from 4 years of age) and adolescents weighing less than 50 kg
Croatian: Djeca (od navršenih 4 godine života) i adolescenti tjelesne težine manje od 50 kg
English: Lacosamide UCB is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adolescents and children from 4 years of age weighing 50 kg or more and in adults with epilepsy.
Croatian: Lakozamid UCB je indiciran kao monoterapija i dodatna terapija u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u adolescenata i djece od navršenih 4 godine života tjelesne težine 50 kg ili veće i u odraslih s epilepsijom.
English: In children from 4 years of age with a body weight of under 20 kg:
Croatian: U djece u dobi od navršenih 4 godine tjelesne težine manje od 20 kg:
English: • The other ingredients are glycerol (E422), carmellose sodium, sorbitol liquid (crystallizing) (E420), polyethylene glycol 4000, sodium chloride, citric acid anhydrous, acesulfame potassium (E950), sodium methyl parahydroxybenzoate (E219), strawberry flavour (contains propylene glycol, maltol), masking flavour (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water), purified water.
Croatian: • Drugi sastojci su: glicerol (E422), karmelozanatrij, sorbitol, tekući (kristalizirajući) (E420), polietilenglikol 4000, natrijev klorid, citratna kiselina, bezvodna, acesulfamkalij (E950), natrijev metilparahidroksibenzoat (E219), aroma jagode (sadrži propilenglikol, maltol), prekrivajuća aroma (sadrži propilenglikol, aspartam (E951), acesulfamkalij (E950), maltol, deioniziranu vodu), pročišćena voda.
English: You may take Lacosamide UCB with or without food.
Croatian: • Lakozamid UCB možete uzimati s hranom ili bez nje.
English: UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Croatian: UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgija.
English: (2) Dosage in adolescents 50 kg or more is the same as in adults.
Croatian: (2) Doziranje za adolescente tjelesne težine jednake ili veće od 50 kg isto je kao za odrasle.
English: There is experience with twice daily infusions of Lacosamide UCB for up to 5 days.
Croatian: Postoji iskustvo s infuzijom lijeka Lakozamid UCB dvaput na dan do 5 dana.
English: The recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week.
Croatian: Preporučena početna doza je 50 mg dvaput na dan, koju nakon tjedan dana treba povećati na početnu terapijsku dozu od 100 mg dvaput na dan.
English: Lacosamide is rapidly and completely absorbed after oral administration.
Croatian: Lakozamid se brzo i u potpunosti apsorbira nakon peroralne primjene.
English: The table below shows the frequencies of adverse reactions which have been reported in clinical trials and post-marketing experience.
Croatian: U donjoj tablici prikazana je učestalost nuspojava prijavljenih u kliničkim istraživanjima i u razdoblju nakon stavljanja lijeka u promet.
English: There is no specific antidote for overdose with lacosamide.
Croatian: Za predoziranje lakozamidom nema specifičnog antidota.
English: A 200 ml amber glass bottle with white polypropylene screw cap, a measuring cup and an oral syringe with an adaptor.
Croatian: Smeđa staklena boca od 200 ml s bijelim polipropilenskim zatvaračem s navojem, mjernom čašom i štrcaljkom za usta s nastavkom.
English: Suicidal ideation Hallucination (1)
Croatian: Suicidalne ideacije Halucinacije(1)
English: If the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time.
Croatian: Ako bolesnik primijeti da je propustio uzeti dozu, a do sljedeće doze je preostalo manje od 6 sati, treba ga uputiti da pričeka i uzme sljedeću dozu lakozamida prema uobičajenom rasporedu.
English: • Runny nose (nasopharyngitis);
Croatian: • curenje iz nosa (nazofaringitis);
English: The minimum extractable volume is 1 ml, which is 10 mg of lacosamide.
Croatian: Minimalni volumen koji se može izvući je 1 ml, što je 10 mg lakozamida.
English: 100 mg tablet: yellow iron oxide (E172).
Croatian: 100 mg tableta: žuti željezov oksid (E172)