FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual starting dose of Lacosamide UCB is 50 mg (5 ml) twice a day.
Croatian: Uobičajena je početna doza lijeka Lakozamid UCB 50 mg (5 ml) dvaput na dan.
English: Sodium (salt): o there are 7.09 mg sodium in each graduation mark (5 ml) of the measuring cup.
Croatian: • natrij (sol): o Svaka odmjerna oznaka (5 ml) mjerne čaše sadrži 7,09 mg natrija.
English: Children and adolescents weighing less than 50 kg Use the oral syringe provided in the carton box.
Croatian: Djeca i adolescenti tjelesne težine manje od 50 kg • Upotrebljavajte štrcaljku za usta isporučenu u kartonskoj kutiji.
English: The tables below provide examples of volumes of syrup per intake depending on prescribed dose and body weight.
Croatian: U sljedećim su tablicama navedeni primjeri volumena sirupa po unosu ovisno o propisanoj dozi i tjelesnoj težini.
English: 14 film-coated tablets 14 x 1 film-coated tablet 28 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablet 168 film-coated tablets
Croatian: 14 filmom obloženih tableta 14 x 1 filmom obložena tableta 28 filmom obloženih tableta 56 filmom obloženih tableta 56 x 1 filmom obložena tableta 168 filmom obložena tableta
English: 14 film-coated tablets 14 x 1 film-coated tablet 28 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablet
Croatian: 14 filmom obloženih tableta 14 x 1 filmom obložena tableta 28 filmom obloženih tableta 56 filmom obloženih tableta 56 x 1 filmom obložena tableta
English: Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention; Noise in the ear such as buzzing, ringing or whistling;
Croatian: • smanjenje osjećanja ili osjetljivosti, poteškoće u izgovoru riječi, poremećaj pažnje;
English: Suicide attempt (1) Suicidal ideation Hallucination (1)
Croatian: Suicidalne ideacije Halucinacije (1)
English: Week 1 Package marked "Week 1"
Croatian: 1. tjedan Pakiranje označeno "1. tjedan "
English: The treatment with Lacosamide UCB may also start with a dose of 100 mg of Lacosamide UCB twice a day.
Croatian: Liječenje lijekom Lakozamid UCB također može započeti dozom od 100 mg lijeka Lakozamid UCB dvaput na dan.
English: Your doctor may also prescribe a starting dose of 100 mg of Lacosamide UCB twice a day.
Croatian: Vaš liječnik također može propisati početnu dozu od 100 mg lijeka Lakozamid UCB dvaput na dan.
English: In paediatric patients weighing 50 kg or more and in adult patients with severe renal impairment (CLCR ≤ 30 ml/min) or with end-stage renal disease, a maximum dose of 250 mg/day is recommended and the dose titration should be performed with caution.
Croatian: U pedijatrijskih bolesnika tjelesne težine 50 kg ili više i u odraslih bolesnika s teškim oštećenjem bubrega (CLCR ≤ 30 ml/min) ili sa završnim stadijem bubrežne bolesti preporučuje se maksimalna doza od 250 mg/dan, a titraciju doze mora se provesti s oprezom.
English: Very common: may affect more than 1 in 10 people Headache;
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 osoba
English: The use of lacosamide is associated with dose-related increase in the PR interval.
Croatian: Primjena lakozamida povezana je s pojavom produljenja PR-intervala koje je ovisno dozi.
English: In children weighing from 40 to under 50 kg, a maximum dose of 10 mg/kg/day is recommended.
Croatian: U djece tjelesne težine od 40 do manje od 50 kg preporučena je maksimalna doza od 10 mg/kg/dan.
English: Agranulocytosis(1)
Croatian: Agranulocitoza(1)
English: Children from 4 years and adolescents under 50 kg: use the oral syringe.
Croatian: Djeca u dobi od navršene 4 godine života i adolescenti tjelesne težine manje od 50 kg: upotrebljavati štrcaljku za usta.
English: Single loading dose
Croatian: Jednokratna udarna doza
English: One full 10 ml oral syringe corresponds to 100 mg of lacosamide.
Croatian: Jedna puna štrcaljka za usta od 10 ml odgovara 100 mg lakozamida.
English: Each pack of 56 film-coated tablets for a 4-week treatment schedule contains: 14 film-coated tablets of Lacosamide UCB 50 mg 14 film-coated tablets of Lacosamide UCB 100 mg 14 film-coated tablets of Lacosamide UCB 150 mg 14 film-coated tablets of Lacosamide UCB 200 mg
Croatian: Jedno pakiranje s 56 filmom obloženih tableta za program 4-tjednog liječenja sadrži: 14 filmom obloženih tableta Lakozamid UCB 50 mg 14 filmom obloženih tableta Lakozamid UCB 100 mg 14 filmom obloženih tableta Lakozamid UCB 150 mg 14 filmom obloženih tableta Lakozamid UCB 200 mg
English: Each graduation mark (5 ml) of the 30 ml measuring cup corresponds to 50 mg of lacosamide (for example 2 graduation marks correspond to 100 mg).
Croatian: Svaka odmjerna oznaka (5 ml) mjerne čaše od 30 ml odgovara 50 mg lakozamida (na primjer, 2 odmjerne oznake odgovaraju 100 mg).
English: if you have a certain type of heart beat problem called second- or third-degree AV block.
Croatian: • ako bolujete od određene vrste poremećaja srčanih otkucaja koji se naziva AV-blok drugog ili trećeg stupnja.
English: If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the missed tablet anymore.
Croatian: • Ako je od propuštene doze proteklo više od 6 sati, nemojte uzimati propuštenu tabletu.
English: Only clear solution free from particles and discoloration should be used.
Croatian: Smije se upotrijebiti samo bistra otopina koja ne sadrži čestice i koja nije promijenila boju.
English: Week 2 Package marked "Week 2"
Croatian: 2. tjedan Pakiranje označeno "2. tjedan "
English: the package marked ‘Week 4' contains 14 tablets of 200 mg.
Croatian: • Pakiranje označeno „4. tjedan“ sadrži 14 tableta od 200 mg.
English: NAME OF THE MARKETING AUTHORISATION HOLDER UCB Pharma S.A.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET UCB Pharma S.A.
English: These trials, involving 1,308 patients with a history of an average of 23 years of partial-onset seizures, were designed to evaluate the efficacy and safety of lacosamide when administered concomitantly with 1-3 antiepileptic medicinal products in patients with uncontrolled partial-onset seizures with or without secondary generalisation.
Croatian: Cilj tih istraživanja bio je ocjenjivati djelotvornost i sigurnost istovremene primjene lakozamida s 1-3 antiepileptička lijeka u bolesnika s nekontroliranim parcijalnim napadajima sa sekundarnom generalizacijom ili bez nje.
English: The discontinuation rate due to adverse reactions was 10.6 % for patients treated with lacosamide and 15.6 % for patients treated with carbamazepine CR.
Croatian: U bolesnika liječenih lakozamidom stopa prekida liječenja zbog nuspojava bila je 10,6 %, a u bolesnika liječenih karbamazepinom CR 15,6 %.
English: the package marked ‘Week 3' contains 14 tablets of 150 mg,
Croatian: • Pakiranje označeno „3. tjedan“ sadrži 14 tableta od 150 mg,
English: the package marked ‘Week 2' contains 14 tablets of 100 mg,
Croatian: • Pakiranje označeno „2. tjedan“ sadrži 14 tableta od 100 mg,
English: In juvenile rats, a reduced body weight was observed at systemic exposure levels similar to the expected clinical exposure.
Croatian: U mladunčadi štakora pri razinama sistemske izloženosti sličnim očekivanoj kliničkoj izloženosti zabilježeno je smanjenje tjelesne težine.
English: Weight 0.1 ml/kg (1 mg/kg)
Croatian: Težina 0,1 ml/kg (1 mg/kg)
English: Based on the analysis of data from a non-inferiority monotherapy clinical trial comparing lacosamide to carbamazepine controlled release (CR), the most frequently reported adverse reactions (≥10%) for lacosamide were headache and dizziness.
Croatian: Na osnovi analize podataka iz kliničkog ispitivanja neinferiornosti monoterapije u kojem se lakozamid uspoređivao s karbamazepinom s kontroliranim oslobađanjem (engl. controlled release, CR), najčešće prijavljene nuspojave (≥ 10 %) za lakozamid bile su glavobolja i omaglica.
English: • if you have a certain type of heart beat problem called second- or third-degree AV block.
Croatian: • ako bolujete od određene vrste poremećaja srčanih otkucaja koji se naziva AV-blok drugog ili trećeg stupnja).
English: Week 4
Croatian: DRUGO 4. tjedan
English: 50 mg tablet: red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132).
Croatian: 50 mg tableta: crveni željezov oksid (E172), crni željezov oksid (E172), indigo carmine aluminium lake (E132)
English: Sleepiness, tiredness or weakness (asthenia);
Croatian: • somnolencija, umor ili slabost (astenija);
English: 1 vial contains 20 ml Lacosamide UCB solution for infusion equivalent to 200 mg lacosamide.
Croatian: 1 bočica sadrži 20 ml Lakozamid UCB otopine za infuziju što odgovara 200 mg lakozamida.
English: Lacosamide should be used with caution in patients with underlying proarrhythmic conditions such as patients with known cardiac conduction problems or severe cardiac disease (e.g. myocardial ischaemia/infarction, heart failure, structural heart disease or cardiac sodium channelopathies) or patients treated with medicinal products affecting cardiac conduction, including antiarrhythmics and sodium channel blocking antiepileptic medicinal products (see section 4.5), as well as in elderly patients.
Croatian: Lakozamid treba oprezno primjenjivati kod bolesnika s podležećim proaritmijskim stanjima kao što su bolesnici s poznatim smetnjama provodljivosti srca ili teškom srčanom bolešću (npr. ishemija/infarkt miokarda, zatajenje srca, strukturna bolest srca ili srčane kanalopatije natrijevih kanala) ili bolesnika na terapiji lijekovima koji utječu na provodljivost srca, uključujući antiaritmike i antiepileptičke lijekove koji blokiraju natrijske kanale (vidjeti dio 4.5), te u starijih bolesnika.
English: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone (polyplasdone XL-10 Pharmaceutical Grade), magnesium stearate.
Croatian: Jezgra tablete: mikrokristalična celuloza, hidroksipropilceluloza, hidroksipropilceluloza (djelomično supstituirana), koloidni, bezvodni silicijev dioksid, krospovidon (poliplasdon XL10 farmaceutske čistoće), magnezijev stearat.
English: In children weighing less than 40 kg, a maximum dose of up to 12 mg/kg/day is recommended.
Croatian: U djece tjelesne težine manje od 40 kg preporučena je maksimalna doza od 12 mg/kg/dan.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Lacosamide UCB 50 mg film-coated tablets Each film-coated tablet contains 50 mg lacosamide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Lakozamid UCB 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg lakozamida.
English: Week 3 Package marked "Week 3"
Croatian: 3. tjedan Pakiranje označeno "3. tjedan "
English: Liver function test abnormal(2)
Croatian: Promijenjeni nalazi jetrene funkcije(2)
English: Week 3
Croatian: DRUGO 3. tjedan
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SAMO VIŠESTRUKA PAKIRANJA
English: In adolescents and adults weighing 50 kg or more, a loading dose of 200 mg may be considered, but further dose titration (> 200 mg daily) should be performed with caution.
Croatian: U adolescenata i odraslih tjelesne težine 50 kg ili više može se razmotriti udarna doza od 200 mg, ali daljnju titraciju doze (>200 mg dnevno) treba provoditi s oprezom.
English: 0.6 ml/kg (6 mg/kg) Maximum recommended dose
Croatian: 0,6 ml/kg (6 mg/kg) Maksimalna preporučena doza
English: 0.5 ml/kg (5 mg/kg) Maximum recommended dose
Croatian: 0,5 ml/kg (5 mg/kg) Maksimalna preporučena doza
English: Each graduation mark (5 ml) of the measuring cup corresponds to 50 mg of lacosamide (for example 2 graduation marks correspond to 100 mg).
Croatian: Svaka odmjerna oznaka (5 ml) mjerne čaše odgovara 50 mg lakozamida (na primjer, 2 odmjerne oznake odgovaraju 100 mg).
English: Adolescents and children weighing 50 kg or more, and adults
Croatian: Adolescenti i djeca tjelesne težine 50 kg ili više, te odrasli
English: What Lacosamide UCB looks like and contents of the pack Lacosamide UCB 10 mg/ml syrup is a slightly viscous clear, colourless to yellow-brown liquid.
Croatian: • Lakozamid UCB 10 mg/ml sirup je blago viskozna, bistra, bezbojna do žutosmeđa tekućina.
English: When you use Lacosamide UCB with other antiepileptic medicines Your doctor will decide the dose of Lacosamide UCB based on your body weight.
Croatian: Kada se Lakozamid UCB upotrebljava s drugim antiepileptičkim lijekovima Vaš će liječnik odlučiti o dozi lijeka Lakozamid UCB na temelju
English: One tablet of Lacosamide UCB 200 mg contains 200 mg lacosamide.
Croatian: Jedna tableta Lakozamid UCB 200 mg sadrži 200 mg lakozamida.
English: When you take Lacosamide UCB with other antiepileptic medicines Your doctor will decide the dose of Lacosamide UCB based on your body weight.
Croatian: Kada se Lakozamid UCB uzima s drugim antiepileptičkim lijekovima Vaš će liječnik odlučiti o dozi lijeka Lakozamid UCB na temelju
English: 150 mg tablet: yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Croatian: 150 mg tableta: žuti željezov oksid (E172), crveni željezov oksid (E172), crni željezov oksid (E172)
English: Lacosamide has a low protein binding of less than 15 %.
Croatian: Na proteine plazme se veže manje od 15 % lakozamida.
English: Fainting;
Croatian: proljev;
English: Product with particulate matter or discolouration should not be used.
Croatian: Lijek koji sadrži čestice ili koji je promijenio boju ne smije se primijeniti.
English: Not known: frequency cannot be estimated from available data Abnormal rapid heartbeat (ventricular tachyarrhythmia);
Croatian: • abnormalno ubrzani otkucaji srca (ventrikularna tahiaritmija);
English: The usual starting dose of Lacosamide UCB is 50 mg twice a day.
Croatian: Uobičajena je početna doza lijeka Lakozamid UCB 50 mg dvaput na dan.
English: Adjunctive therapy
Croatian: Dodatna terapija
English: Each ml of syrup contains 10 mg lacosamide.
Croatian: Jedan ml sirupa sadrži 10 mg lakozamida.
English: Tablet core microcrystalline cellulose hydroxypropylcellulose hydroxypropylcellulose (low substituted) silica, colloidal, anhydrous crospovidone (polyplasdone XL-10 Pharmaceutical Grade) magnesium stearate
Croatian: Jezgra tablete mikrokristalična celuloza hidroksipropilceluloza hidroksipropilceluloza (djelomično supstituirana) silicijev dioksid, koloidni, bezvodni krospovidon (poliplasdon XL - 10 farmaceutske čistoće) magnezijev stearat
English: Lacosamide plasma concentrations were not affected by carbamazepine and by valproic acid.
Croatian: Karbamazepin i valproatna kiselina nisu utjecali na koncentracije lakozamida u plazmi.
English: Salmon, oval film-coated tablets with approximate dimensions of 15.1 mm x 7.0 mm, and debossed with ‘SP' on one side and ‘150' on the other side.
Croatian: Boje lososa, ovalne filmom obložene tablete približnih dimenzija 15,1 mm x 7,0 mm, s utisnutim „SP“ na jednoj strani i „150“ na drugoj strani.
English: 1 ml Lacosamide UCB solution for infusion contains 10 mg lacosamide.
Croatian: 1 ml Lakozamid UCB otopine za infuziju sadrži 10 mg lakozamida.
English: Based on data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic impairment a reduction of 25% of the maximum dose should be applied.
Croatian: Na temelju podataka o odraslim bolesnicima, u pedijatrijskih bolesnika tjelesne težine manje od 50 kg s blagim do umjerenim oštećenjem jetre maksimalnu dozu treba smanjiti za 25 %.
English: The pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment (see section 4.2).
Croatian: Farmakokinetika lakozamida u bolesnika s teškim oštećenjem jetre nije ispitana (vidjeti dio 4.2).
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Croatian: OBLIK I SADRŽAJ 14 filmom obloženih tableta 4. tjedan
English: Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose.
Croatian: Incidencija nuspojava SŽS-a kao što je omaglica može biti pojačana nakon udarne doze.
English: Progesterone concentrations were not affected when the medicinal products were co-administered.
Croatian: Istovremena primjena lijekova nije utjecala na koncentracije progesterona.
English: Lacosamide UCB 150 mg are salmon, oval film-coated tablets of approximately 15.1 mm x 7.0 mm with a debossed ‘SP' on one side and ‘150' on the other side.
Croatian: • Lakozamid UCB 150 mg su boje lososa, ovalne filmom obložene tablete približnih dimenzija 15,1 mm x 7,0 mm, s utisnutim „SP“ na jednoj strani i „150“ na drugoj strani.
English: Patients should be made aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular pulse, palpitations, shortness of breath, feeling lightheaded, fainting).
Croatian: Bolesnike treba obavijestiti o simptomima srčane aritmije (npr. usporen, ubrzan ili nepravilan puls, palpitacije, nedostatak zraka, osjećaj ošamućenosti, nesvjestica), te ih upozoriti da u slučaju pojave tih simpoma odmah zatraže savjet liječnika.
English: A single loading dose of 200 mg approximates steady-state concentrations comparable to 100 mg twice daily oral administration.
Croatian: Postizanje koncentracija u stanju dinamičke ravnoteže kod jednokratne udarne doze od 200 mg usporedivo je s koncentracijama kod oralne primjene100 mg dvaput dnevno.
English: Packs of 14, 28, 56 and 168 film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Croatian: Pakiranja od 14, 28, 56 i 168 filmom obloženih tableta u PVC/PVDC blisteru, zatvorenom aluminijskom folijom.
English: One tablet of Lacosamide UCB 50 mg contains 50 mg lacosamide.
Croatian: Jedna tableta Lakozamid UCB 50 mg sadrži 50 mg lakozamida.
English: Packs of 14 x 1 and 56 x 1 film-coated tablet in PVC/PVDC perforated unit dose blisters sealed with an aluminium foil.
Croatian: Pakiranje od 14 x 1 i 56 x 1 filmom obloženih tableta u PVC/PVDC perforiranim blisterima s jediničnim dozama, zatvorenim aluminijskom folijom.
English: 1 ml Lacosamide UCB syrup contains 10 mg lacosamide.
Croatian: 1 ml Lakozamid UCB sirupa sadrži 10 mg lakozamida.
English: 0.4 ml/kg (4 mg/kg) Maximum recommended dose
Croatian: 0,4 ml/kg (4 mg/kg) Maksimalna preporučena doza
English: The maximum recommended dose is 5 mg (0.5 ml), for each kg of body weight, twice a day.
Croatian: Maksimalna preporučena doza je 5 mg (0,5 ml) na svaki kg tjelesne težine, dva puta na dan.
English: Lacosamide UCB 50 mg Lacosamide UCB 100 mg Lacosamide UCB 150 mg Lacosamide UCB 200 mg
Croatian: Lakozamid UCB 50 mg Lakozamid UCB 100 mg Lakozamid UCB 150 mg Lakozamid UCB 200 mg
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: Ako doživite bilo koju od sljedećih nuspojava, obratite se svom liječniku ili ljekarniku:
English: 150 mg (1 tablet Lacosamide UCB 150 mg)
Croatian: 150 mg (1 tableta Lakozamid UCB 150 mg)
English: 200 mg (1 tablet Lacosamide UCB 200 mg)
Croatian: 200 mg (1 tableta Lakozamid UCB 200 mg)
English: The tables below provide guidance on the volume of solution for infusion per administration depending on prescribed dose and body weight.
Croatian: U sljedećim su tablicama navedene smjernice o volumenu otopine za infuziju po primjeni ovisno o propisanoj dozi i tjelesnoj težini.
English: One tablet of Lacosamide UCB 150 mg contains 150 mg lacosamide.
Croatian: Jedna tableta Lakozamid UCB 150 mg sadrži 150 mg lakozamida.
English: The tables below provide examples of volumes of solution for infusion per administration depending on prescribed dose and body weight.
Croatian: U sljedećim su tablicama navedeni primjeri volumena otopine za infuziju po primjeni ovisno o propisanoj dozi i tjelesnoj težini.
English: In paediatric patients weighing 50 kg or more and in adult patients with mild or moderate renal impairment a loading dose of 200 mg may be considered, but further dose titration (> 200 mg daily) should be performed with caution.
Croatian: U pedijatrijskih bolesnika tjelesne težine 50 kg ili više i u odraslih bolesnika s blagim ili umjerenim oštećenjem bubrega može se razmotriti mogućnost udarne doze od 200 mg, ali daljnju titraciju doze (>200 mg dnevno) treba provoditi s oprezom.
English: The maximum recommended dose is 4 mg (0.4 ml), for each kg of body weight, twice a day.
Croatian: Maksimalna preporučena doza je 4 mg (0,4 ml) na svaki kg tjelesne težine, dva puta na dan.
English: Aggression Agitation(1) Euphoric mood(1)
Croatian: Euforično raspoloženje(1)
English: When you take Lacosamide UCB with other antiepileptic medicines The usual starting dose of Lacosamide UCB is 50 mg (5 ml) twice a day.
Croatian: Kad primjenjujete Lakozamid UCB s drugim antiepileptičkim lijekovima Uobičajena je početna doza lijeka Lakozamid UCB 50 mg (5 ml) dvaput na dan.
English: If you weigh 50 kg or more, your doctor may decide to start Lacosamide UCB treatment with a single “loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.
Croatian: Ako je Vaša tjelesna težina 50 kg ili više, Vaš liječnik može odlučiti započeti liječenje lijekom Lakozamid UCB jednokratnom „udarnom“ dozom od 200 mg.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide UCB.
Croatian: Ako se bilo koja od gornjih tvrdnji odnosi na Vas (ili niste sigurni u to), obratite se svom liječniku ili ljekarniku prije nego primite Lakozamid UCB.
English: Sore throat (pharyngitis);
Croatian: • upala grla (faringitis);
English: The treatment initiation pack contains 56 film-coated tablets in 4 packages: the package marked ‘Week 1'contains 14 tablets of 50 mg,
Croatian: Pakiranje za početak liječenja sadrži 56 filmom obloženih tableta u 4 pakiranja:
English: INFORMATION IN BRAILLE Lacosamide UCB 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Lakozamid UCB 150 mg
English: INFORMATION IN BRAILLE Lacosamide UCB 200 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Lakozamid UCB 200 mg
English: Adolescents and children weighing 50 kg or more and adults When you take Lacosamide UCB on its own
Croatian: Adolescenti i djeca tjelesne težine 50 kg ili više i odrasli Kad uzimate samoLakozamid UCB
English: Manufacturer Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany or UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
Croatian: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Njemačka ili
English: The following table summarises the recommended posology in adjunctive therapy for children and adolescents weighing less than 50 kg.
Croatian: U sljedećoj je tablici sažeto prikazano preporučeno doziranje u dodatnoj terapiji za djecu i adolescente tjelesne težine manje od 50 kg.
English: Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml) for each kg of body weight.
Croatian: Vaš liječnik zatim može povećati dozu koju uzimate dvaput na dan svakih tjedan dana za 1 mg (0,1 ml) na svaki kg tjelesne težine, dok ne dosegnete dozu održavanja.
English: NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 10 mg/ml syrup
Croatian: NAZIV LIJEKA Lakozamid UCB 10 mg/ml sirup
English: The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
Croatian: Uobičajena je početna doza 1 mg (0,1 ml) na svaki kilogram (kg) tjelesne težine, dvaput na dan.
English: Carton 14 tablets - week 1
Croatian: Kutija 14 tableta - 1. tjedan
English: o there are 3.5 mg sodium in each 2.5 ml dose from the oral syringe.
Croatian: o Svaka doza od 2,5 ml iz štrcaljke za usta sadrži 3,5 mg natrija.
English: One tablet of Lacosamide UCB 100 mg contains 100 mg lacosamide.
Croatian: Jedna tableta Lakozamid UCB 100 mg sadrži 100 mg lakozamida.
English: Dosing oral syringe (10 ml graduated every 0.25 ml) with an adaptor (for children and adolescents from 4 years of age weighing less than 50 kg)
Croatian: Dozirna štrcaljka za usta (10 ml s odmjernim oznakama za svakih 0,25 ml) s nastavkom (za djecu u dobi od navršenih 4 godine života i adolescente tjelesne težine manje od 50 kg) Jedna puna štrcaljka za usta (10 ml) odgovara 100 mg lakozamida.
English: Pinkish, oval film-coated tablets with approximate dimensions of 10.4 mm x 4.9 mm, and debossed with ‘SP' on one side and ‘50' on the other side.
Croatian: Ružičaste, ovalne filmom obložene tablete približnih dimenzija 10,4 mm x 4,9 mm, s utisnutim „SP“ na jednoj strani i „50“ na drugoj strani.