FrancophonIA/ELRC3.0 huggingface dataset:
English: For precautionary measures, breast-feeding should be discontinued during treatment with lacosamide.
Slovenian: Iz previdnosti je treba v času zdravljenja z lakozamidom dojenje prekiniti.
English: Common: may affect up to 1 in 10 people Injection site pain or discomfort or irritation.
Slovenian: Pogosti: pojavijo se lahko pri največ 1 do 10 bolnikov • bolečina ali nelagodje na mestu infundiranja ali draženje.
English: Do not take Lacosamide UCB if any of the above applies to you.
Slovenian: Zdravila Lakozamid UCB ne jemljite, če za vas velja kar koli od zgoraj navedenega.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta obrazložitev glede neuporabe Braillove pisave.
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Slovenian: Če o tem niste prepričani, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Lacosamide does not inhibit or induce CYP2C19 and CYP3A4 to a clinically relevant extent.
Slovenian: Lakozamid ne zavira in ne inducira CYP2C19 in CYP3A4 v klinično pomembnem obsegu.
English: Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) Lacosamide UCB 50 mg film-coated tablets
Slovenian: Pakiranje za začetek zdravljenja (le za mladostnike in otroke, ki tehtajo 50 kg ali več, in odrasle) Lakozamid UCB 50 mg filmsko obložene tablete
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.
Slovenian: Pri sočasnem zdravljenju z močnimi zaviralci CYP2C9 (npr. flukonazol) in CYP3A4 (npr. itrakonazol, ketokonazol, ritonavir, klaritromicin) moramo biti previdni, saj lahko povzročijo povečano sistemsko izpostavljenost lakozamida.
English: The oral bioavailability of lacosamide tablets is approximately 100 %.
Slovenian: Biološka uporabnost tablet lakozamida po peroralni uporabi je približno 100 %.
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.
Slovenian: Lakozamid je treba uporabljati previdno pri bolnikih, ki se že zdravijo z zdravili, za katera je znano, da podaljšajo interval P-R (vključno z antiepileptiki, ki zavirajo natrijeve kanalčke), ter pri bolnikih, ki se zdravijo z antiaritmiki.
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.
Slovenian: Uporabljeni odmerki lakozamida so bili od 2 do 17,8 mg/kg/dan pri vnosu dvakrat dnevno do največ 600 mg/dan pri otrocih, ki tehtajo 50 kg ali več.
English: Maximum recommended dose up to 600 mg/day up to 400 mg/day
Slovenian: Največji priporočeni odmerek do 600 mg/dan do 400 mg/dan
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.
Slovenian: Zdravilo Lakozamid UCB je na voljo v pakiranjih po 14, 28, 56, 14 x 1 in 56 x 1 filmsko obložena tableta in v skupnem pakiranju, ki vsebuje 3 škatle s po 56 tabletami.
English: Lacosamide UCB may make you dizzy - this could increase the risk of accidental injury or a fall.
Slovenian: Zdravilo Lakozamid UCB lahko povzroča omotico, kar lahko poveča tveganje za naključne poškodbe ali padce.
English: Table: Start of the treatment (the first 4 weeks) Week Package to be used
Slovenian: Preglednica: Začetek zdravljenja (prvi 4 tedni) Teden
English: Depending on response and tolerability, the maintenance dose can be further increased by 2 mg/kg/day every week.
Slovenian: Glede na odziv in prenašanje zdravila se lahko vzdrževalni odmerek nadalje vsak teden poveča za 2 mg/kg/dan.
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.
Slovenian: Pri otrocih, ki tehtajo od 20 do manj kot 30 kg, je priporočeni največji odmerek 10 mg/kg/dan in pri otrocih, ki tehtajo od 30 do manj kot 50 kg, je priporočeni največji odmerek 8 mg/kg/dan, čeprav je bil v odprtih študijah (glejte poglavji 4.8 in 5.2) pri majhnem številu takšnih otrok uporabljen odmerek do 12 mg/kg/dan.
English: Other medicines and Lacosamide UCB
Slovenian: Druga zdravila in zdravilo Lakozamid UCB
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX18 Mechanism of action
Slovenian: Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX18 Mehanizem delovanja
English: In the repeated dose toxicity studies, mild reversible liver changes were observed in rats starting at about 3 times the clinical exposure.
Slovenian: Pri študijah toksičnosti pri ponavljajočih se odmerkih so pri podganah opazili blage, reverzibilne spremembe jeter, ki so se pojavile pri koncentracijah, ki so približno 3-kratnik klinične izpostavljenosti.
English: The CYP2C19 inhibitor omeprazole (40 mg once daily) did not give rise to a clinically significant change in lacosamide exposure.
Slovenian: Omeprazol, zaviralec CYP2C19, (40 mg enkrat na dan) ni povečal klinično pomembnih sprememb v izpostavljenosti lakozamida.
English: Clinical trials indicate that gender does not have a clinically significant influence on the plasma concentrations of lacosamide.
Slovenian: Klinična preskušanja kažejo, da spol nima klinično pomembnega vpliva na plazemske koncentracije lakozamida.
English: Children (from 4 years of age) and adolescents weighing below 50 kg This presentation is not suitable for this category of patients.
Slovenian: Otroci (od 4. leta starosti) in mladostniki, ki tehtajo manj kot 50 kg Ta oblika ni primerna za bolnike te kategorije.
English: Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system.
Slovenian: Simptomi, opaženi po nenamernem ali namernem prevelikem odmerjanju lakozamida, so povezani predvsem s centralnim živčnim sistemom in prebavili.
English: PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 56 filmsko obloženih tablet.
English: Sodium methyl parahydroxybenzoate (E219) may cause allergic reactions (possibly delayed).
Slovenian: • Natrijev metilparahidroksibenzoat (E219) lahko povzroča alergijske reakcije (možno z zakasnitvijo).
English: An infusion duration of at least 30 minutes for administration > 200 mg per infusion (i.e. > 400 mg/day) is preferred.
Slovenian: Zaželjeno trajanje infuzije za aplikacijo > 200 mg na infuzijo (to je > 400 mg/dan) je vsaj 30 minut.
English: Adolescents and children weighing 50 kg or more Dosage in adolescents and children weighing 50 kg or more is the same as in adults (see above).
Slovenian: Mladostniki in otroci, ki tehtajo 50 kg ali več Odmerek pri mladostnikih in otrocih, ki tehtajo 50 kg ali več, je enak kot pri odraslih (glejte zgoraj).
English: Each ml of Lacosamide UCB syrup contains 187 mg sorbitol (E420), 2.60 mg sodium methyl parahydroxybenzoate (E219), 0.032 mg aspartame (E951), and 1.42 mg sodium.
Slovenian: En ml sirupa zdravila Lakozamid UCB vsebuje 187 mg sorbitola (E420), 2,60 mg natrijevega metilparahidroksibenzoata (E219), 0,032 mg aspartama (E951) in 1,42 mg natrija.
English: Lacosamide UCB syrup contains sodium methyl parahydroxybenzoate (E219), which may cause allergic reactions (possibly delayed).
Slovenian: Zdravilo Lakozamid UCB sirup vsebuje natrijev metilparahidroksibenzoat (E219), ki lahko povzroča alergijske reakcije (možno z zakasnitvijo).
English: Furthermore an interaction trial with omeprazole (CYP2C19-inhibitor) demonstrated no clinically relevant changes in lacosamide plasma concentrations indicating that the importance of this pathway is minor.
Slovenian: Poleg tega preskušanje medsebojnega delovanja z omeprazolom (zaviralec CYP2C19) ni pokazalo klinično pomembnih sprememb plazemskih koncentracij lakozamida, kar kaže, da je ta presnovna pot manj pomembna.
English: In the monotherapy clinical trial comparing lacosamide to carbamazepine CR, syncope was reported in 7/444 (1.6 %) lacosamide patients and in 1/442 (0.2 %) carbamazepine CR patients.
Slovenian: V kliničnem preskušanju samostojnega zdravljenja, kjer so primerjali lakozamid s karbamazepinom z nadzorovanim sproščanjem, so o sinkopi poročali pri 7/444 (1,6 %) bolnikih, ki so prejemali lakozamid in pri 1/442 (0,2 %) bolnikih, ki so prejemali karbamazepin z nadzorovanim sproščanjem.
English: Initiation of lacosamide treatment with a loading dose Lacosamide treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen.
Slovenian: Začetek zdravljenja z lakozamidom z začetnim (polnilnim) odmerkom Zdravljenje z lakozamidom lahko začnemo tudi z enkratnim začetnim (polnilnim) odmerkom 200 mg, ki mu po približno 12 urah sledi vzdrževalni režim odmerjanja 100 mg dvakrat na dan (200 mg/dan).
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.
Slovenian: Študije in vitro kažejo, da lakozamid v plazemskih koncentracijah, izmerjenih v kliničnih preskušanjih, ne inducira encimov CYP1A2, CYP2B6 in CYP2C9 ter ne zavira encimov CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6 in CYP2E1.
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).
Slovenian: Pri samcih in samicah podgan niso opazili neželenih učinkov na plodnost ali na sposobnost razmnoževanja pri odmerkih, ki povzročijo plazemsko izpostavljenost (AUC) do približno 2-krat plazemske AUC pri ljudeh pri največjem priporočenem odmerku za človeka.
English: if you have a certain type of heart beat problem called second- or third-degree AV block.
Slovenian: če imate določeno vrsto težav s srčnim ritmom, ki se imenuje atrioventrikularni blok druge ali tretje stopnje.
English: Marketing Authorisation Holder UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Slovenian: Imetnik dovoljenja za promet z zdravilom UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgija.
English: How to store Lacosamide UCB Contents of the pack and other information
Slovenian: Shranjevanje zdravila Lakozamid UCB Vsebina pakiranja in dodatne informacije
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.
Slovenian: Glede na odziv in prenašanje, lahko bolnik zdravilo Lakozamid UCB 150 mg tablete v tretjem tednu jemlje dvakrat na dan in v četrtem tednu zdravilo Lakozamid UCB 200 mg tablete dvakrat na dan.
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.
Slovenian: Ni znano, ali povečana izpostavljenost presnovku pri bolnikih s končno ledvično odpovedjo povzroči tudi povečanje neželenih učinkov, čeprav niso opazili farmakološke aktivnosti presnovkov.
English: Contains sorbitol (E420), sodium methyl parahydroxybenzoate (E219), aspartame (E951), and sodium.
Slovenian: Vsebuje sorbitol (E420), natrijev metilparahidroksibenzoat (E219), aspartam (E951) in natrij.
English: Psychotic disorder(1)
Slovenian: psihotična motnja(1)
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.
Slovenian: V času nosečnosti ali dojenja jemanje zdravila Lakozamid UCB ni priporočljivo, ker učinki zdravila Lakozamid UCB na nosečnost, nerojenega ali novorojenega otroka niso znani.
English: Solution for infusion is an alternative for patients when oral administration is temporarily not feasible.
Slovenian: Raztopina za infundiranje predstavlja alternativno možnost zdravljenja za bolnike, pri katerih peroralna uporaba zdravila trenutno ni mogoča.
English: PHARMACEUTICAL FORM AND CONTENTS 1 x 20 ml solution for infusion 200 mg/20 ml
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 1 x 20 ml raztopine za infundiranje 200 mg/20 ml
English: There are two ways in which you can choose to drink the medicine: empty the contents of the oral syringe into a little water by pushing the piston to the bottom of the oral syringe (figure 11) - you will then need to drink all of the water (add just enough to make it easy to drink) or drink the solution directly from the oral syringe without water (figure 12) - drink the whole contents of the oral syringe.
Slovenian: • vsebino brizge za peroralno odmerjanje izpraznite v kozarec z malo vode, tako da pritisnete na bat vse do dna brizge za peroralno odmerjanje (slika 11) - potem boste morali spiti vso vodo (nalijte je toliko, da jo boste zlahka spili) ali
English: The plasma concentration of O-desmethyl-lacosamide is approximately 15 % of the concentration of lacosamide in plasma.
Slovenian: Plazemska koncentracija O-desmetil-lakozamida predstavlja približno 15 % plazemske koncentracije lakozamida.
English: The maximum recommended dose is 400 mg/day.
Slovenian: Največji priporočeni odmerek je zato 400 mg/dan.
English: DATE OF REVISION OF THE TEXT Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Co-administration of warfarin with lacosamide does not result in a clinically relevant change in the pharmacokinetics and pharmacodynamics of warfarin.
Slovenian: Sočasna uporaba varfarina in lakozamida ne povzroči klinično pomembne spremembe v farmakokinetiki in farmakodinamiki varfarina.
English: Adolescents and children weighing 50 kg or more, and adults The following table summarises the recommended posology for adolescents and children weighing 50 kg or more, and for adults.
Slovenian: Mladostniki in otroci, ki tehtajo 50 kg ali več, in odrasli Naslednja preglednica vsebuje povzetek priporočenega odmerjanja pri mladostnikih in otrocih, ki tehtajo 50 kg ali več, in pri odraslih.
English: In absence of haemodialysis in patients with end-stage renal disease, the levels were increased and continuously rising during the 24-hour sampling.
Slovenian: Če bolniki s končno ledvično odpovedjo niso na dializi, se njegove koncentracije povečujejo in med 24-urnim vzorčenjem vztrajno rastejo.
English: This was reported with lacosamide in 4.8 % (3/62) in elderly patients versus 1.6 % (6/382) in younger adult patients.
Slovenian: O tem so pri lakozamidu poročali pri 4,8 % (3/62) starejših bolnikov v primerjavi z 1,6 % (6/382) mlajšimi odraslimi bolniki.
English: 100 mg/day or 200 mg/day 100 mg/day
Slovenian: 100 mg/dan ali 200 mg/dan 100 mg/dan
English: Lacosamide UCB tablets and syrup are bioequivalent.
Slovenian: Tablete in peroralni sirup zdravila Lakozamid UCB so bioekvivalentni.
English: Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Lacosamide UCB patients and 0 % (0/356) of placebo patients.
Slovenian: Povišane vrednosti ALT na ≥ 3x zgornjo mejo normalnih vrednosti (ULN-upper limit of normal), so se pojavile pri 0,7 % (7/935) bolnikov, ki so jemali zdravilo Lakozamid UCB, in pri 0 % (0/356) bolnikov, ki so jemali placebo.
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).
Slovenian: Sirupu lakozamida je priložena merica z graduacijskimi oznakami (za bolnike, ki tehtajo 50 kg ali več) in brizga za peroralno dajanje z nastavkom (za bolnike, ki tehtajo manj kot 50 kg).
English: Do not drive, cycle or use any tools or machines until you know how this medicine affects you.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Dokler ne veste, kako to zdravilo deluje na vas, ne vozite, kolesarite in ne uporabljajte orodij.
English: Incidence and severity of central nervous system (CNS) and gastrointestinal (GI) adverse reactions usually decreased over time.
Slovenian: Incidenca in resnost neželenih učinkov, povezanih s centralnim živčnim sistemom in prebavili, sta se običajno s časom zmanjševali.
English: You may take Lacosamide UCB with or without food.
Slovenian: • Zdravilo Lakozamid UCB lahko jemljete s hrano ali brez nje.
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.
Slovenian: V dopolnilnih kliničnih preskušanjih pri bolnikih z epilepsijo je bila incidenca atrioventrikularnega bloka prve stopnje opredeljena kot občasni neželeni učinek, ki se je pojavil pri 0,7 %, 0 %, 0,5 % oziroma 0 % bolnikov, ki so jemali lakozamid v odmerku 200 mg, 400 mg, 600 mg oziroma placebo.
English: Lacosamide UCB is used in adults, adolescents and children aged 4 years and older.
Slovenian: • Zdravilo Lakozamid UCB se uporablja pri odraslih, mladostnikih in otrocih, starih 4 leta in več.
English: In vivo data
Slovenian: Podatki in vivo
English: you have a heart problem that affects the beat of your heart and you often have a particulary slow, fast or irregular heart beat (such as AV block, atrial fibrillation and atrial flutter).
Slovenian: • imate težave s srcem, ki vplivajo na bitje vašega srca in imate pogosto posebej počasno, hitro ali neredno bitje (npr. atrioventrikularni blok, atrijska fibrilacija in atrijska undulacija);
English: Lacosamide UCB is available in a bottle of 200 ml.
Slovenian: • Zdravilo Lakozamid UCB je na voljo v steklenicah po 200 ml.
English: Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of lacosamide (approximately 50 % higher AUCnorm).
Slovenian: Plazemske koncentracije lakozamida so bile pri bolnikih z zmerno jetrno okvaro (Child-Pugh B) povečane (približno 50 % večje kot AUCnorm).
English: Risk related to lacosamide There are no adequate data from the use of lacosamide in pregnant women.
Slovenian: Tveganje, povezano z lakozamidom O uporabi lakozamida pri nosečnicah ni zadostnih podatkov.
English: (2) Dosage in adolescents 50 kg or more is the same as in adults.
Slovenian: (2) Odmerek pri mladostnikih, ki tehtajo 50 kg ali več, je enak kot pri odraslih.
English: When you take Lacosamide UCB on its own
Slovenian: Ko boste vzeli zdravilo Lakozamid UCB samostojno
English: It is not recommended to use 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.
Slovenian: V času nosečnosti ali dojenja uporaba zdravila Lakozamid UCB ni priporočljivo, ker učinki zdravila Lakozamid UCB na nosečnost, nerojenega ali novorojenega otroka niso znani.
English: Problems in keeping your balance, shaking (tremor), tingling (paresthesia) or muscle spasms, falling easily and getting bruises;
Slovenian: • težave z ravnotežjem, tresenje (tremor), mravljinčenje (parestezija) ali mišični krči, pogosto padanje in modrice;
English: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany.
Slovenian: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Nemčija.
English: Your doctor will show you how to use the oral syringe, before you use it for the first time.
Slovenian: Zdravnik vam bo pred prvo uporabo pokazal, kako uporabljati brizgo za peroralno odmerjanje.
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
Slovenian: 14 filmsko obloženih tablet 14 x 1 filmsko obložena tableta 28 filmsko obloženih tablet 56 filmsko obloženih tablet 56 x 1 filmsko obložena tableta 168 filmsko obloženih tablet
English: A 200 ml amber glass bottle with white polypropylene screw cap, a measuring cup and an oral syringe with an adaptor.
Slovenian: 200 ml rjava steklenica z belo polipropilensko navojno zaporko, merico in brizgo za peroralno odmerjanje z nastavkom.
English: Your doctor will work out the right dose for you:
Slovenian: Pravilni odmerek vam bo določil zdravnik.
English: PHARMACEUTICAL FORM AND CONTENTS 200 ml syrup with measuring cup and oral syringe
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 200 ml sirupa z merico in brizgo za peroralno odmerjanje
English: Data generally suggest that lacosamide has a low interaction potential.
Slovenian: V splošnem podatki kažejo, da ima lakozamid majhen potencial medsebojnega delovanja z drugimi zdravili.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER UCB Pharma S.A.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM UCB Pharma S.A.
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.
Slovenian: Stopnja prekinitev zaradi neželenih učinkov je bila 10,6 % za bolnike, ki so se zdravili lakozamidom in 15,6 % za bolnike, ki so se zdravili s karbamazepinom z nadzorovanim sproščanjem.
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).
Slovenian: Skrbno spremljajte bolnike z znanimi motnjami prevodnosti srca, pri sočasni uporabi zdravil, ki podaljšajo interval P-R ali pri resnih srčnih obolenjih (npr. miokardni infarkt v anamnezi ali srčno popuščanje) v primerih, ko je odmerek lakozamida večji od 400 mg/dan (glejte spodaj Način uporabe in poglavje 4.4).
English: Do not stop treatment without talking to your doctor first as this could increase your fits (seizures).
Slovenian: Zdravljenja ne prekinite, preden se ne posvetujete z zdravnikom, saj bi se število vaših napadov (krčev) zaradi tega lahko povečalo.
English: Lacosamide is rapidly and completely absorbed after oral administration.
Slovenian: Lakozamid se po peroralni uporabi hitro in popolnoma absorbira.
English: Carton of 168 film-coated tablets containing 3 Cartons of 56 film-coated tablets (with Blue box)
Slovenian: Škatla s 168 filmsko obloženimi tabletami, ki vsebuje 3 škatle s po 56 filmsko obloženimi tabletami (z modrim poljem)
English: Taking Lacosamide UCB on its own - This is for information only.
Slovenian: Samostojno jemanje zdravila Lakozamid UCB - to navodilo je le informativno.
English: 6.1 List of excipients water for injections sodium chloride hydrochloric acid (for pH adjustment)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi voda za injekcije natrijev klorid klorovodikova kislina (za uravnavanje pH)
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
Slovenian: 14 filmsko obloženih tablet 14 x 1 filmsko obložena tableta 28 filmsko obloženih tablet 56 filmsko obloženih tablet 56 x 1 filmsko obložena tableta
English: A slightly viscous clear, colourless to yellow-brown liquid.
Slovenian: sirup Rahlo viskozna, bistra tekočina brezbarvne do rumeno-rjave barve.
English: No dose adjustment is necessary in mildly and moderately renally impaired adult and paediatric patients (CLCR > 30 ml/min).
Slovenian: Pri blagi in zmerni ledvični okvari prilagoditev odmerka pri odraslih in pediatričnih bolnikih ni potrebna (CLCR > 30 ml/min).