FrancophonIA/ELRC3.0 huggingface dataset:
English: Close the bottle with the plastic screw cap (you do not need to remove the adaptor).
Croatian: • Zatvorite bocu plastičnim zatvaračem s navojem (ne trebate ukloniti nastavak).
English: (2) See Description of selected adverse reactions.
Croatian: (2) Vidjeti Opis izdvojenih nuspojava.
English: Lacosamide UCB may be used on its own or with other antiepileptic medicines.
Croatian: • Lakozamid UCB se može koristiti samostalno ili s drugim antiepileptičkim lijekovima.
English: Therefore, clinically relevant interactions with other medicinal products through competition for protein binding sites are considered unlikely.
Croatian: Stoga se klinički značajne interakcije s drugim lijekovima zbog kompetitivnog vezanja za proteine smatraju malo vjerojatnima.
English: It is given over 15 to 60 minutes.
Croatian: Infuzija traje od 15 do 60 minuta.
English: Irritability Feeling drunk
Croatian: Razdražljivost Osjećaj opijenosti
English: Irritability Feeling drunk Injection site pain or discomfort (4) Irritation(4)
Croatian: Razdražljivost Osjećaj opijenosti Bol ili nelagoda na mjestu injekcije (4) Iritacija(4)
English: Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
Croatian: • prekomjerni osjećaj dobrog raspoloženja, vidite i/ili čujete stvari koje ne postoje;
English: They were usually mild to moderate in intensity.
Croatian: Njihov intenzitet obično je bio blag do umjeren.
English: The precise mechanism by which lacosamide exerts its antiepileptic effect in humans remains to be fully elucidated.
Croatian: Točan mehanizam kojim lakozamid iskazuje svoj antiepileptički učinak kod ljudi još uvijek nije potpuno pojašnjen.
English: The usual dose that may be taken per day for each of the first 4 weeks of treatment is shown in the following table.
Croatian: Uobičajena doza koja se smije uzeti u jednom danu za svaki od prva 4 tjedna liječenja je prikazana u sljedećoj tablici.
English: Use the measuring cup provided in this pack.
Croatian: • Koristite mjernu čašu isporučenu u ovom pakiranju.
English: Small amounts (0.5-2 %) of additional metabolites were found in the urine.
Croatian: U mokraći su nađene male količine (0,5-2 %) drugih metabolita.
English: Each package has 14 tablets, corresponding to 2 tablets per day for 7 days.
Croatian: Jedno pakiranje ima 14 tableta, što odgovara 2 tabletama na dan tijekom 7 dana.
English: These transient changes started in the same concentration range as after maximum recommended clinical dosing.
Croatian: Te prolazne promjene javljale su se kod istog raspona koncentracija kao i nakon maksimalno preporučenog kliničkog doziranja.
English: Cardiac rhythm and conduction
Croatian: Srčani ritam i provodljivost
English: Incidence and severity of central nervous system (CNS) and gastrointestinal (GI) adverse reactions usually decreased over time.
Croatian: Incidencija i težina nuspojava središnjeg živčanog sustava (SŽS) i gastrointestinalnog (GI) sustava obično su se smanjivale tijekom vremena.
English: Not known: frequency cannot be estimated from available data Changes in behaviour, not acting like themselves.
Croatian: Nepoznato: ne može se procijeniti iz dostupnih podataka • mijenja im se ponašanje, ne ponašaju se uobičajeno.
English: The bottle containing Lacosamide UCB syrup should be shaken well before use.
Croatian: Boca koja sadrži Lakozamid UCB sirup mora se dobro protresti prije uporabe.
English: This is to prevent your epilepsy from coming back again or becoming worse.
Croatian: To se radi kako bi se sprječilo da se epilepsija ponovno pojavi ili da postane teža.
English: Pharmacokinetics in special patient groups
Croatian: Farmakokinetika kod posebnih skupina bolesnika
English: Shake well before use.
Croatian: Dobro protresti prije uporabe
English: Accordingly, patients should be advised not to drive or to operate other potentially hazardous machinery until they are familiar with the effects of lacosamide on their ability to perform such activities.
Croatian: U skladu s tim bolesnike treba savjetovati da ne upravljaju vozilima ili drugim potencijalno opasnim strojevima dok se ne upoznaju s učincima lakozamida na njihovu sposobnost obavljanja takvih aktivnosti.
English: The dose should be gradually adjusted until the optimum response is obtained.
Croatian: Dozu treba postupno prilagođavati dok se ne dobije optimalan odgovor.
English: Since higher exposure levels could not be tested in animals due to maternal toxicity, data are insufficient to fully characterise the embryofetotoxic and teratogenic potential of lacosamide.
Croatian: S obzirom na to da izloženost višim vrijednostima nije mogla biti ispitana na životinjama zbog toksičnosti za majku, nema dovoljno podataka koji bi okarakterizirali potpuni embriofetotoksični i teratogeni potencijal lakozamida.
English: (3) Reported in open-label studies.
Croatian: (3) Prijavljeno u otvorenim ispitivanjima.
English: Your doctor may prescribe a different dose if you have problems with your kidneys or with your liver.
Croatian: Liječnik može propisati drugačiju dozu ako imate problema s bubrezima ili jetrima.
English: The solution for infusion is infused over a period of 15 to 60 minutes twice a day.
Croatian: Otopina za infuziju se infundira u razdoblju od 15 do 60 minuta dvaput dnevno.
English: This substance may be harmful for people with phenylketonuria (a rare metabolic disease).
Croatian: Ta tvar može biti štetna u osoba s fenilketonurijom (rijetka metabolička bolest).
English: Subsequent dose adjustments should be performed according to individual response and tolerability as described above.
Croatian: Daljnje prilagodbe doziranja treba provesti ovisno o individualnom odgovoru i podnošljivosti kao što je gore opisano.
English: • Fever (pyrexia);
Croatian: • vrućica (pireksija);
English: Lacosamide syrup must be taken orally.
Croatian: Lakozamid sirup se mora uzeti oralno.
English: Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine (see section 4.8).
Croatian: Stoga bolesnike treba savjetovati da budu oprezni dok se ne upoznaju s mogućim učincima tog lijeka (vidjeti dio 4.8).
English: Lacosamide UCB is used as a long term treatment.
Croatian: Lakozamid UCB se koristi za dugotrajno liječenje.
English: The packages are marked with ‘week 1 (2, 3 or 4)'.
Croatian: Pakiranja su označena s ʻ1. (2., 3. ili 4.) tjedan'.
English: Each package contains a different dosage strength of Lacosamide UCB, so you will increase your dose gradually.
Croatian: Svako pakiranje sadrži drugu jačinu doze lijeka Lakozamid UCB, tako da ćete Vašu dozu postupno povećavati.
English: The pack contains 4 different packages for the first 4 weeks of treatment, one package for each week.
Croatian: Pakiranje sadrži 4 različita pakiranja za prva 4 tjedna liječenja, jedno pakiranje za svaki tjedan.
English: Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower legs;
Croatian: • ozbiljna alergijska reakcija koja uzrokuje oticanje lica, grla, ruke, stopala, gležnjeva ili potkoljenica;
English: The study consisted of an 8-week baseline period followed by a 6-week titration period.
Croatian: Ispitivanje se sastojalo od početnog razdoblja u trajanju od 8 tjedana nakon čega je uslijedilo razdoblje titracije u trajanju od 6 tjedana.
English: The total daily dose and twice daily administration should be maintained.
Croatian: Potrebno je održavati ukupnu dnevnu dozu i primjenu dvaput na dan.
English: Cardiac conduction disorders, shock and coma have also been observed.
Croatian: Također su opaženi poremećaji srčane provodljivosti, šok i koma.
English: A small number of people being treated with antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves.
Croatian: Mali broj ljudi koji se liječe antiepileptičkim lijekovima kao što je lakozamid imali su misli o samoozljeđivanju ili samoubojstvu.
English: Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
Croatian: • brzi i nekontrolirani pokreti očiju (nistagmus), zamućen vid;
English: • Convulsion.
Croatian: • konvulzije.
English: There is limited clinical data in the elderly patients with epilepsy, particularly at doses greater than 400 mg/day (see sections 4.4, 4.8, and 5.1).
Croatian: Postoje ograničeni klinički podaci u starijih bolesnika s epilepsijom, osobito kod doza većih od 400 mg/dan (vidjeti dijelove 4.4, 4.8 i 5.1).
English: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have been reported in patients treated with some antiepileptic medicinal products.
Croatian: Multiorganske reakcije preosjetljivosti (također poznate kao reakcija na lijek s eozinofilijom i sistemskim simptomima, DRESS) zabilježene su u bolesnika koji su liječeni nekim antiepileptičkim lijekovima.
English: Studies in animals did not indicate any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats and rabbits at maternal toxic doses (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala nikakve teratogene učinke kod štakora ili zečeva, ali je zabilježena embriotoksičnost kod štakora i zečeva kod doza toksičnih za majke (vidjeti dio 5.3).
English: You need to know this if you are on a controlled sodium diet.
Croatian: To morate znati ako ste na prehrani s ograničenim unosom natrija.
English: Therefore, starting or ending treatment with these enzyme inducers should be done with caution.
Croatian: Dakle, treba biti oprezan kod započinjanja ili prestanka liječenja tim induktorima enzima.
English: 50 mg twice a day (100 mg/day) at weekly intervals
Croatian: 50 mg dvaput na dan (100 mg/dan) u tjednim intervalima
English: Balance disorder Memory impairment Cognitive disorder Somnolence Tremor
Croatian: Poremećaji ravnoteže Oštećenje pamćenja Kognitivni poremećaj Somnolencija Tremor
English: The safety and efficacy of lacosamide in children aged below 4 years have not yet been established.
Croatian: Sigurnost i djelotvornost lakozamida u djece mlađe od 4 godine nisu još ustanovljene.
English: A general dose reduction is not considered to be necessary unless indicated due to reduced renal function (see section 4.2).
Croatian: Opće smanjenje doze smatra se nepotrebnim osim ako nije indicirano zbog smanjene funkcije bubrega (vidjeti dio 4.2).
English: You should continue to take Lacosamide UCB until your doctor tells you to stop.
Croatian: Lakozamid UCB morate nastaviti uzimati sve dok Vam liječnik ne odredi da prestanete.
English: Lacosamide UCB treatment initiation pack contains 4 different packages (one for each tablet strength) with 14 tablets each, for the first 2 to 4 weeks of therapy depending on the patient's response and tolerability.
Croatian: Lakozamid UCB pakiranje za početak liječenja sadrži 4 različita pakiranja (jedno za svaku jačinu tablete), svako s 14 tableta, za prva 2 do 4 tjedna terapije ovisno o odgovoru i podnošljivosti bolesnika.
English: Subjects must have achieved the minimum target dose for their body weight category for the final 3 days of the titration period to be eligible for entry into the 10-week maintenance period.
Croatian: Ispitanici su morali postići minimalnu ciljanu dozu za svoju tjelesnu težinu za posljednja 3 dana razdoblja titracije kako bi bili podobni za ulaz u razdoblje održavanja u trajanju od 10 tjedana.
English: In vitro data
Croatian: Podaci in vitro
English: In post-marketing experience, AV block (including second degree or higher AV block) has been reported.
Croatian: Nakon stavljanja lijeka u promet zabilježen je AV blok (uključujući AV blok drugog ili višeg stupnja).
English: Although no pharmacokinetic data on the interaction of lacosamide with alcohol are available, a pharmacodynamic effect cannot be excluded.
Croatian: Iako nema dostupnih farmakokinetičkih podataka o interakcijama lakozamida i alkohola, ne može se isključiti farmakodinamički učinak.
English: 95 % of the dose is excreted in the urine as lacosamide and metabolites.
Croatian: 95 % doze izlučuje se mokraćom u obliku lakozamida i metabolita.
English: The plasma concentration increases proportionally with dose after oral (100-800 mg) and intravenous (50-300 mg) administration.
Croatian: Koncentracija u plazmi se povećava proporcionalno s dozom nakon peroralne (100-800 mg) i intravenske (50-300 mg) primjene.
English: A sore throat, high temperature and getting more infections than usual.
Croatian: • grlobolja, visoka tjelesna temperatura i učestalije infekcije nego uobičajeno.
English: Aspartame (E951): a source of phenylalanine.
Croatian: • aspartam (E951): izvor fenilalanina.
English: Table: Start of the treatment (the first 4 weeks) Week Package to be used
Croatian: Tablica: Početak liječenja (prva 4 tjedna) Tjedan Pakiranje koje se koristi
English: It should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8).
Croatian: Treba je primijeniti pod liječničkim nadzorom uzimajući u obzir potencijal za povećanu incidenciju ozbiljne srčane aritmije i nuspojava središnjeg živčanog sustava (vidjeti dio 4.8).
English: In juvenile rats and dogs, the types of toxicity do not differ qualitatively from those observed in adult animals.
Croatian: Vrste toksičnosti zabilježene u mladunčadi štakora i štenadi ne razlikuju se kvalitativno od onih zabilježenih u odraslih životinja.
English: Such interactions have not been established in vivo but are possible based on in vitro data.
Croatian: Takve interakcije nisu utvrđene in vivo, ali su moguće temeljem podataka in vitro.
English: Packs of 1x20 ml and 5x20 ml.
Croatian: Pakiranja od 1x20 ml i 5x20 ml.
English: The efficacy of lacosamide in children aged 4 years and older has been extrapolated from data of adolescents and adults with partial-onset seizures, for whom a similar response was expected provided the paediatric dose adaptations are established (see section 4.2) and safety has been demonstrated (see section 4.8).
Croatian: Djelotvornost lakozamida u djece u dobi od 4 godine i starije ekstrapolirana je iz podataka o adolescentima i odraslima s parcijalnim napadajima za koje se očekivao sličan odgovor uz uvjet da su uspostavljene prilagodbe pedijatrijske doze (vidjeti dio 4.2) i da je dokazana sigurnost (vidjeti dio 4.8).
English: Instructions for use: measuring cup
Croatian: Upute za uporabu: mjerna čaša
English: • Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, seizures (generalised tonic-clonic seizures, status epilepticus).
Croatian: • Reakcije prijavljene nakon uzimanja doza većih od 800 mg su omaglica, mučnina, povraćanje, napadaji (generalizirani toničko-klonički napadaji, status epilepticus).
English: If you have any of these thoughts at any time, tell your doctor straight away.
Croatian: Ako Vam se ikada pojave takve misli, odmah obavijestite svog liječnika.
English: These changes included an increased organ weight, hypertrophy of hepatocytes, increases in serum concentrations of liver enzymes and increases in total cholesterol and triglycerides.
Croatian: Promjene su obuhvaćale povećanu masu organa, hipertrofiju hepatocita, povišene koncentracije jetrenih enzima u serumu te povišen ukupni kolesterol i trigliceride.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge (see section 4.8).
Croatian: Bolesnike (i njegovatelje bolesnika) treba upozoriti da potraže liječnički savjet ako se pojave znakovi suicidalnih ideacija ili ponašanja (vidjeti dio 4.8).
English: A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Croatian: Metaanaliza randomiziranih, placebom kontroliranih ispitivanja antiepileptičkih lijekova također je pokazala blago povećan rizik od suicidalnih ideacija i ponašanja.
English: The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal and generalised seizures may coexist have not been determined.
Croatian: Sigurnost i djelotvornost lakozamida u pedijatrijskih bolesnika s epileptičkim sindromima u kojima mogu zajedno postojati žarišni i generalizirani napadaji nisu utvrđene.
English: Chemin du Foriest B-1420 Braine-L'Alleud BELGIUM
Croatian: Chemin du Foriest B-1420 Braine-L'Alleud BELGIJA
English: • The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 800 mg were not clinically different from those of patients administered recommended doses of lacosamide.
Croatian: • Vrste nuspojava koje su se javile u bolesnika izloženih dozama iznad 400 mg pa sve do 800 mg nisu bile klinički različite od onih u bolesnika koji su primjenjivali preporučene doze lakozamida.
English: In accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week).
Croatian: Sukladno trenutačnoj kliničkoj praksi, ako treba prekinuti primjenu lakozamida, preporučeno je postupno ukidanje lijeka (npr. smanjivanje dnevne doze za 200 mg/tjedan).
English: Outer carton / bottle
Croatian: Vanjska kutija / boca
English: Shake the bottle well before use.
Croatian: Protresite dobro bocu prije uporabe.
English: Behavioural, cognition and emotional functioning were measured by the questionnaires Achenbach CBCL and BRIEF that were applied at baseline and throughout the studies and where mainly stable during the course of the trials.
Croatian: Bihevioralno, kognitivno i emocionalno funkcioniranje mjereno upitnicima Achenbach CBCL i BRIEF koji su primijenjeni u početnoj točki ispitivanja i kroz cijelo ispitivanje i uglavnom su bili stabilni tijekom ispitivanja.
English: Additional side effects when given as an intravenous infusion There may be local side effects.
Croatian: Dodatne nuspojave pri primjeni u obliku intravenske infuzije Moguće su lokalne nuspojave.
English: Thus, the 600 mg/day dose is not recommended.
Croatian: Stoga se doza od 600 mg/dan ne preporučuje.
English: This medicinal product is for single use only, any unused solution should be discarded.
Croatian: Lijek je samo za jednokratnu uporabu, svu neiskorištenu otopinu treba baciti.
English: However, a higher incidence (≥ 5 % difference) of fall, diarrhoea and tremor has been reported in elderly patients compared to younger adult patients.
Croatian: Međutim, zabilježena je veća incidencija (≥ 5 % razlike) padova, proljeva i tremora u starijih bolesnika u odnosu na mlađe odrasle bolesnike.
English: Risk related to epilepsy and antiepileptic medicinal products in general For all antiepileptic medicinal products, it has been shown that in the offspring of treated women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population.
Croatian: Rizik povezan s epilepsijom i antiepileptici općenito Za sve antiepileptičke lijekove pokazalo se da se u potomstva majki liječenih zbog epilepsije rizik od nastanka malformacija dvostruko ili trostruko povećava u usporedbi s očekivanom incidencijom u općoj populaciji od oko 3 %.
English: In non-clinical experiments lacosamide in combination with levetiracetam, carbamazepine, phenytoin, valproate, lamotrigine, topiramate or gabapentin showed synergistic or additive anticonvulsant effects.
Croatian: Neklinički pokusi pokazali su da lakozamid u kombinaciji s levetiracetamom, karbamazepinom, fenitoinom, valproatom, lamotriginom, topiramatom ili gabapentinom ima sinergističke ili aditivne antikonvulzivne učinke.
English: Antiepileptic medicinal products
Croatian: Antiepileptički lijekovi
English: Studies in rats revealed that lacosamide and/or its metabolites readily crossed the placental barrier.
Croatian: Ispitivanja na štakorima pokazala su da lakozamid i/ili njegovi metaboliti lako prolaze placentalnu barijeru.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika i ne bi smjeli trajati dulje od 24 sata na temperaturi od 2 do 8°C, osim ako razrjeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: Depression Confusional state Insomnia(1)
Croatian: Depresija Konfuzno stanje Nesanica(1)
English: For longer term treatment Lacosamide UCB tablets and syrup are available.
Croatian: Za dugotrajnije liječenje dostupne su Lakozamid UCB tablete i sirup.
English: The major compounds excreted in urine are unchanged lacosamide (approximately 40 % of the dose) and its O-desmethyl metabolite less than 30 %.
Croatian: Glavninu sastojaka izlučenih mokraćom čine nepromijenjen lakozamid (otprilike 40 % doze) i njegov O-dezmetilni metabolit manje od 30 %.
English: Treatment of patients with end-stage renal disease should be made with caution as there is little clinical experience and accumulation of a metabolite (with no known pharmacological activity).
Croatian: Liječenje bolesnika sa završnim stadijem bubrežne bolesti zahtijeva oprez zbog nedovoljnog kliničkog iskustva i zbog nakupljanja metabolita (bez poznate farmakološke aktivnosti).
English: This dose is called a maintenance dose and will depend on how you respond to Lacosamide UCB.
Croatian: Ta doza naziva se dozom održavanja i ovisit će o Vašem odgovoru na Lakozamid UCB.
English: In vivo data
Croatian: Podaci in vivo
English: Lacosamide must be taken twice a day (usually once in the morning and once in the evening).
Croatian: Lakozamid se mora uzimati dvaput na dan (obično jedanput ujutro i jedanput navečer).
English: The overall duration of treatment with intravenous lacosamide is at the physician's discretion; there is experience from clinical trials with twice daily infusions of lacosamide for up to 5 days in adjunctive therapy.
Croatian: O ukupnom trajanju liječenja intravenskim lakozamidom odlučuje liječnik; postoji iskustvo iz kliničkih ispitivanja s infuzijama lakozamida dvaput dnevno do 5 dana u dodatnoj terapiji.
English: A spinning sensation (vertigo), feeling drunk;
Croatian: • osjećaj vrtnje (vrtoglavica), osjećaj opijenosti;
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Lacosamide UCB syrup contains sorbitol (E420).
Croatian: Lakozamid UCB sirup sadrži sorbitol (E420).
English: In the toxicity studies, the plasma concentrations of lacosamide obtained were similar or only marginally higher than those observed in patients, which leaves low or non-existing margins to human exposure.
Croatian: U ispitivanjima toksičnosti koncentracije lakozamida u plazmi bile su slične ili samo neznatno veće od onih uočenih kod bolesnika, što predstavlja male granice izloženosti kod ljudi ili ih uopće nema.
English: For most patients the maintenance dose is between 200 mg and 400 mg per day.
Croatian: Za većinu bolesnika doza održavanja je između 200 mg i 400 mg na dan.
English: The dose was based on dose-response and ranged from 400 to 1,200 mg/day for carbamazepine CR and from 200 to 600 mg/day for lacosamide.
Croatian: Doziranje je bilo temeljeno na odgovoru na dozu i u rasponu od 400 do 1200 mg/dan za karbamazepin CR i od 200 do 600 mg/dan za lakozamid.
English: Known second- or third-degree atrioventricular (AV) block.
Croatian: Poznati atrioventrikularni (AV) blok drugog ili trećeg stupnja.
English: Swallow the Lacosamide UCB tablet with a glass of water.
Croatian: • Progutajte tabletu lijeka Lakozamid UCB uz čašu vode.