FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common adverse reaction resulting in discontinuation of lacosamide therapy was dizziness.
Slovenian: Neželeni učinek, zaradi katerega so bolniki najpogosteje prekinili zdravljenje z lakozamidom, je bila omotica.
English: In the treated population, an increase in malformations has been noted with polytherapy, however, the extent to which the treatment and/or the illness is responsible has not been elucidated.
Slovenian: V kolikšni meri je za to odgovorno zdravljenje in/ali sama bolezen, ni pojasnjeno.
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.
Slovenian: Priporočeni začetni odmerek je 50 mg dvakrat na dan, ki ga je treba po enem tednu povečati na začetni terapevtski odmerek 100 mg dvakrat na dan.
English: Maximum recommended dose in patients < 40 kg up to 12 mg/kg/day Maximum recommended dose in patients ≥ 40 kg to < 50 kg up to 10 mg/kg/day
Slovenian: Največji priporočeni odmerek pri bolnikih < 40 kg do 12 mg/kg/dan Največji priporočeni odmerek pri bolnikih ≥ 40 kg do < 50 kg do 10 mg/kg/dan
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.
Slovenian: Zdravilo Lakozamid UCB raztopina za infundiranje je fizikalno kompatibilna in kemijsko stabilna vsaj 24 ur pri temperaturi do 25 °C, če je shranjena v steklenicah ali PVC vrečah in je bila pripravljena s spodaj navedenimi raztopinami.
English: Your doctor may also prescribe a starting dose of 100 mg (10 ml) of Lacosamide UCB twice a day.
Slovenian: Zdravnik vam lahko predpiše tudi začetni odmerek 100 mg (10 ml) zdravila Lakozamid UCB dvakrat na dan.
English: Week 4 Package marked "Week 4"
Slovenian: 4. teden Pakiranje z oznako "4. teden"
English: On the first day of treatment the patient starts with Lacosamide UCB 50 mg tablets twice a day.
Slovenian: Prvi dan zdravljenja začne bolnik z zdravilom Lakozamid UCB 50 mg tablete dvakrat na dan.
English: The estimated 6-month seizure freedom rates were 89.8 % for lacosamide-treated patients and 91.1 % for carbamazepine CR treated patients using the Kaplan-Meier survival analysis method.
Slovenian: Ocenjeno razmerje 6-mesečnega obdobja brez napadov je bilo z uporabo analize preživetja po metodi Kaplan-Meier 89,8 % za bolnike, ki so se zdravili z lakozamidom in 91,1 % za bolnike, ki so se zdravili s karbamazepinom z nadzorovanim sproščanjem.
English: Children and adolescent weighing less than 50 kg The dose depends on their body weight.
Slovenian: Otroci in mladostniki, ki tehtajo manj kot 50 kg, in odrasli Odmerek je odvisen od njihove telesne mase.
English: This will be until you reach a maintenance dose of between 100 mg (10 ml) and 300 mg (30 ml) twice a day.
Slovenian: Odmerek bo povečeval dokler ne boste dosegli vzdrževalnega odmerka med 100 mg (10 ml) in 300 mg (30 ml) dvakrat na dan.
English: Tablet core: microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose (low substituted), colloidal anhydrous silica, crospovidone (polyplasdone XL-10 Pharmaceutical Grade), magnesium stearate.
Slovenian: Jedro tablete: mikrokristalna celuloza, hidroksipropilceluloza, hidroksipropilceluloza (delno substituirana) koloidni silicijev dioksid, krospovidon (farmacevtski poliplasdon XL-10), magnezijev stearat
English: Very common: may affect more than 1 in 10 people Headache;
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
English: Antiepileptic medicinal products
Slovenian: Antiepileptiki
English: Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25°C for product mixed with these diluents and stored in glass or PVC bags.
Slovenian: Dokazali so, da je raztopina med uporabo kemijsko in fizikalno stabilna 24 ur pri 25 °C, če je bilo zdravilo razredčeno s temi raztopinami in shranjeno v steklenicah ali PVC vrečah.
English: Week 1 Package marked "Week 1"
Slovenian: 1. teden Pakiranje z oznako "1. teden"
English: What Lacosamide UCB looks like and contents of the pack
Slovenian: Izgled zdravila Lakozamid UCB in vsebina pakiranja
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused solution should be discarded.
Slovenian: ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI Neuporabljeno raztopino zavrzite.
English: Fall Skin laceration Contusion (1) Adverse reactions reported in post marketing experience.
Slovenian: Poškodbe, zastrupitve in padec kožna laceracija zapleti pri posegih kontuzija (1) Neželeni učinki o katerih so poročali v obdobju trženja.
English: After this, each graduation mark (0.25 ml) corresponds to 2.5 mg of lacosamide (for example 4 graduation marks corresponds to 10 mg).
Slovenian: Po tem vsaka graduacijska oznaka (0,25 ml) ustreza 2,5 mg lakozamida (na primer 4 graduacijske oznake ustrezajo 10 mg).
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
English: In paediatric patients weighing less than 50 kg with severe renal impairment (CLCR ≤ 30 ml/min) and in those with end-stage renal disease, a reduction of 25 % of the maximum dose is recommended.
Slovenian: Pri pediatričnih bolnikih, ki tehtajo manj kot 50 kg, s hudo ledvično okvaro (CLCR ≤ 30 ml/min) in pri tistih s končno ledvično odpovedjo je priporočeno 25-% zmanjšanje največjega odmerka.
English: Maximum recommended dose in patients ≥ 30 kg to < 50 kg up to 8 mg/kg/day
Slovenian: Največji priporočeni odmerek pri bolnikih ≥ 30 kg do < 50 kg do 8 mg/kg/dan
English: In an interaction trial there was no clinically relevant interaction between lacosamide and the oral contraceptives ethinylestradiol and levonorgestrel.
Slovenian: V preskušanjih medsebojnega delovanja z drugimi zdravili niso opazili klinično pomembnih interakcij med lakozamidom in peroralnima kontraceptivoma etinilestradiolom in levonorgestrelom.
English: Week 1
Slovenian: DRUGI PODATKI 1. teden
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
Slovenian: Vsako pakiranje s 56 filmsko obloženimi tabletami za 4-tedensko zdravljenje vsebuje: 14 filmsko obloženih tablet zdravila Lakozamid UCB 50 mg 14 filmsko obloženih tablet zdravila Lakozamid UCB 100 mg 14 filmsko obloženih tablet zdravila Lakozamid UCB 150 mg 14 filmsko obloženih tablet zdravila Lakozamid UCB 200 mg
English: Your doctor will decide the dose of Lacosamide UCB based on your body weight.
Slovenian: Vaš zdravnik bo določil odmerek zdravila Lakozamid UCB glede na vašo telesno maso.
English: If you stop taking Lacosamide UCB
Slovenian: Če ste prenehali jemati zdravilo Lakozamid UCB
English: EU/1/19/1383/010 EU/1/19/1383/011 EU/1/19/1383/012 EU/1/19/1383/013 EU/1/19/1383/014 EU/1/19/1383/015 EU/1/19/1383/016 EU/1/19/1383/017 EU/1/19/1383/018 EU/1/19/1383/019 EU/1/19/1383/020 EU/1/19/1383/021 EU/1/19/1383/022 EU/1/19/1383/023 EU/1/19/1383/024 EU/1/19/1383/025 EU/1/19/1383/026 EU/1/19/1383/027
Slovenian: EU/1/19/1383/004 EU/1/19/1383/005 EU/1/19/1383/006 EU/1/19/1383/007 EU/1/19/1383/008 EU/1/19/1383/009 EU/1/19/1383/010 EU/1/19/1383/011 EU/1/19/1383/012 EU/1/19/1383/013 EU/1/19/1383/014 EU/1/19/1383/015 EU/1/19/1383/016 EU/1/19/1383/017 EU/1/19/1383/018 EU/1/19/1383/019 EU/1/19/1383/020 EU/1/19/1383/021 EU/1/19/1383/022 EU/1/19/1383/023
English: Lacosamide UCB is used in adolescents and children aged 4 years and older weighing 50 kg or more and in adults.
Slovenian: • Zdravilo Lakozamid UCB se uporablja pri mladostnikih in otrocih, starih 4 leta ali več, ki tehtajo 50 kg ali več, in pri odraslih.
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Navedba smiselno ni potrebna
English: The measuring cup is suitable for adults, adolescents and children weighing 50 kg and above.
Slovenian: • Merica je primerna za odrasle, mladostnike in otroke, ki tehtajo 50 kg in več.
English: The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients (see section 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter farmakokinetike lakozamida niso preučevali (glejte poglavje 5.2).
English: Turn the bottle upside down (figure 5).
Slovenian: • steklenico obrnite na glavo (slika 5);
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING TREATMENT INITIATION PACK ONLY Intermediate Carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI SAMO ZA PAKIRANJE ZA ZAČETEK ZDRAVLJENJA Notranja škatla
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for infusion contains 10 mg lacosamide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En mililiter raztopine za infundiranje vsebuje 10 mg lakozamida.
English: The usual starting dose of Lacosamide UCB is 50 mg twice a day.
Slovenian: Običajen začetni odmerek zdravila Lakozamid UCB je 50 mg dvakrat na dan.
English: The minimum extractable volume is 1 ml, which is 10 mg of lacosamide.
Slovenian: Najmanjši volumen, ki ga je mogoče izvleči, je 1 ml, kar ustreza 10 mg lakozamida.
English: the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
Slovenian: Običajen začetni odmerek je 1 mg (0,1 ml) za vsak kilogram (kg) telesne mase, dvakrat na dan.
English: Lacosamide UCB solution for infusion can be administered intravenously without further dilution or can be diluted with sodium chloride 9 mg/ml (0.9 %) solution for injection, glucose 50 mg/ml (5 %) solution for injection or lactated Ringer's solution for injection.
Slovenian: Raztopino za infundiranje Lakozamid UCB lahko intravensko apliciramo brez dodatnega redčenja ali jo lahko redčimo z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje, raztopino glukoze 50 mg/ml (5 %) za injiciranje ali raztopino Ringerjevega laktata za injiciranje
English: In reproductive and developmental toxicity studies in rodents and rabbits, no teratogenic effects but an increase in numbers of stillborn pups and pup deaths in the peripartum period, and slightly reduced live litter sizes and pup body weights were observed at maternal toxic doses in rats corresponding to systemic exposure levels similar to the expected clinical exposure.
Slovenian: V študijah vplivov na sposobnost razmoževanja in toksičnosti za razvoj zarodka pri glodavcih in kuncih niso opazili teratogenih učinkov pri odmerkih, toksičnih za samico podgane, ki ustrezajo sistemski izpostavljenosti, podobni pričakovani klinični izpostavljenosti.
English: If multiorgan hypersensitivity reaction is suspected, lacosamide should be discontinued.
Slovenian: Če obstaja sum za preobčutljivostne reakcije, kjer je prizadetih več organskih sistemov hkrati, moramo zdravljenje z lakozamidom prekiniti.
English: 0.1 ml/kg (1 mg/kg) Starting dose
Slovenian: 0,1 ml/kg (1 mg/kg) začetni odmerek
English: Your doctor may increase your twice daily dose every week by 50 mg (5 ml).
Slovenian: Zdravnik vam lahko poveča dnevni odmerek, razdeljen na dva odmerka, vsak teden za 50 mg (5 ml).
English: The use of lacosamide is associated with dose-related increase in the PR interval.
Slovenian: Uporaba lakozamida je povezana s podaljšanjem intervala P-R, ki je odvisno od odmerka.
English: In children weighing from 40 to under 50 kg, a maximum dose of 10 mg/kg/day is recommended.
Slovenian: Pri otrocih, ki tehtajo od 40 do manj kot 50 kg, je priporočen največji odmerek 10 mg/kg/dan.
English: Multipacks containing 168 (3 packs of 56 tablets) film-coated tablets in PVC/PVDC blister sealed with an aluminium foil.
Slovenian: Skupno pakiranje vsebuje 168 (3 škatle s 56 tabletami) filmsko obloženih tablet v PVC/PVDC pretisnih omotih, pokritih z aluminijasto folijo.
English: o there are 3.5 mg sodium in each 2.5 ml dose from the oral syringe.
Slovenian: o V vsakem 2,5-ml odmerku iz brizge za peroralno odmerjanje je 3,5 mg natrija.
English: In the monotherapy clinical trial comparing lacosamide to carbamazepine CR, the extent of increase in PR interval was comparable between lacosamide and carbamazepine.
Slovenian: V kliničnem preskušanju samostojnega zdravljenja, kjer so primerjali lakozamid s karbamazepinom z nadzorovanim sproščanjem, je bilo povečano podaljšanje intervala P-R primerljivo med lakozamidom in karbamazepinom z nadzorovanim sproščanjem.
English: The treatment with Lacosamide UCB may also start with a dose of 100 mg of Lacosamide UCB twice a day.
Slovenian: Zdravljenje z zdravilom Lakozamid UCB se lahko začne tudi z odmerkom 100 mg dvakrat na dan.
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.
Slovenian: V primerjavi z zdravimi preiskovanci, pri katerih je bila Cmax nespremenjena, se je pri bolnikih z blago do zmerno ledvično okvaro AUC lakozamida povečala za približno 30 %, pri bolnikih s hudo ledvično okvaro in bolnikih s končno ledvično odpovedjo, ki potrebujejo dializo, pa za 60 %.
English: Lacosamide protected against seizures in a broad range of animal models of partial and primary generalised seizures and delayed kindling development.
Slovenian: Na širokem spektru živalskih modelov s parcialnimi in primarno generaliziranimi napadi so pokazali, da lakozamid varuje pred epileptičnimi napadi in zakasni razvoj epileptogenih sprememb.
English: 200 mg tablet: indigo carmine aluminium lake (E132).
Slovenian: 200 mg tableta: indigotin (E132)
English: Common: may affect up to 1 in 10 children
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 otrok
English: 2 mg/kg/day
Slovenian: 2 mg/kg/dan
English: Angioedema(1) Urticaria(1)
Slovenian: angioedem(1) urtikarija(1)
English: Atrioventricular block(1,2)
Slovenian: atrijska undulacija(1,2)
English: When you take Lacosamide UCB with other antiepileptic medicines Your doctor will decide the dose of Lacosamide UCB based on your body weight.
Slovenian: Ko boste vzeli zdravilo Lakozamid UCB skupaj z drugimi antiepileptiki Zdravnik bo določil odmerek zdravila Lakozamid UCB glede na vašo telesno maso.
English: Week 2 Package marked "Week 2"
Slovenian: 2. teden Pakiranje z oznako "2. teden"
English: Do not take Lacosamide UCB if you are allergic to lacosamide, or any of the other ingredients of this medicine (listed in Section 6).
Slovenian: • če ste alergični na lakozamid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: In children weighing less than 40 kg, a maximum dose of up to 12 mg/kg/day is recommended.
Slovenian: Pri otrocih, ki tehtajo manj kot 40 kg, je priporočen največji odmerek do 12 mg/kg/dan.
English: One full 10 ml oral syringe corresponds to 100 mg of lacosamide.
Slovenian: Ena polna 10 ml brizga za peroralno odmerjanje ustreza 100 mg lakozamida.
English: Sodium (salt): o there are 7.09 mg sodium in each graduation mark (5 ml) of the measuring cup.
Slovenian: • Natrij (sol): o vsaka graduacijska oznaka (5 ml) merice vsebuje 7,09 mg natrija.
English: Nervous system side effects such as dizziness may be higher after a single “loading” dose.
Slovenian: Neželenih učinkov na centralni živčni sistem, kot je omotica, je lahko po enkratnem »začetnem« (polnilnem) odmerku več.
English: Tablet core microcrystalline cellulose hydroxypropylcellulose hydroxypropylcellulose (low substituted) silica, colloidal, anhydrous crospovidone (polyplasdone XL-10 Pharmaceutical Grade) magnesium stearate
Slovenian: Jedro tablete mikrokristalna celuloza hidroksipropilceluloza hidroksipropilceluloza (delno substituirana) brezvodni koloidni silicijev dioksid krospovidon (farmacevtski poliplasdon XL-10) magnezijev stearat
English: Lacosamide UCB 10 mg/ml solution for infusion is a clear, colourless solution.
Slovenian: • Zdravilo Lakozamid UCB 10 mg/ml raztopina za infundiranje je bistra, brezbarvna raztopina.
English: Decreased feeling or sensitivity, difficulty in articulating words, disturbance in attention; Noise in the ear such as buzzing, ringing or whistling;
Slovenian: • zmanjšani občutki ali občutljivost, težave pri izražanju besed, motnje v pozornosti;
English: Agranulocytosis(1)
Slovenian: urtikarija(1)
English: When you use Lacosamide UCB with other antiepileptic medicines Your doctor will decide the dose of Lacosamide UCB based on your body weight.
Slovenian: Ko zdravilo Lakozamid UCB uporabljate skupaj z drugimi antiepileptiki Zdravnik bo določil odmerek zdravila Lakozamid UCB glede na vašo telesno maso.
English: Children and adolescents weighing less than 50 kg Use the oral syringe and the adaptor provided in this pack.
Slovenian: Otroci in mladostniki, ki tehtajo manj kot 50 kg • Uporabite brizgo za peroralno odmerjanje in nastavek, ki sta priložena temu pakiranju.
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.
Slovenian: Pri mladostnikih in odraslih, ki tehtajo 50 kg ali več, lahko uporabimo začetni (polnilni) odmerek 200 mg, vendar moramo biti pri nadaljnji titraciji odmerka (> 200 mg na dan) previdni.
English: Dosing was initiated at a dose of 2 mg/kg/day in subjects weighing less than 50 kg or 100 mg/day in subjects weighing 50 kg or more in 2 divided doses.
Slovenian: Odmerjanje se je začelo z odmerkom 2 mg/kg/dan pri osebah, ki so tehtale manj kot 50 kg, ali 100 mg/dan pri osebah, ki so tehtale 50 kg ali več, razdeljenim na 2 odmerka.
English: If you have any questions, please go back to your doctor or pharmacist.
Slovenian: Če imate kakršno koli vprašanje, se obrnite na zdravnika ali farmacevta.
English: Week 3 Package marked "Week 3"
Slovenian: 3. teden Pakiranje z oznako "3. teden"
English: Your doctor may also prescribe a starting dose of 100 mg of Lacosamide UCB twice a day.
Slovenian: Zdravnik vam lahko predpiše tudi začetni odmerek 100 mg zdravila Lakozamid UCB dvakrat na dan.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS ONLY
Slovenian: PODATKI NA ZUNANJI OVOJNINI SAMO ZA SKUPNA PAKIRANJA
English: The 14 x 1 and 56 x 1 film-coated tablet packs are available as perforated unit dose PVC/PVDC blisters sealed with an aluminium foil, all other packs are available with standard PVC/PVDC blisters sealed with an aluminium foil.
Slovenian: Pakiranji 14 x 1 in 56 x 1 filmsko obložena tableta sta na voljo v PVC/PVDC perforiranih pretisnih omotih za posamezni odmerek, pokritih z aluminijasto folijo, druga pakiranja pa v standardnih PVC/PVDC pretisnih omotih, pokritih z aluminijasto folijo.
English: However, cases with second- and third-degree AV Block associated with lacosamide treatment have been reported in postmarketing experience.
Slovenian: Vendar pa so v obdobju trženja poročali o primerih atrioventrikularnega bloka druge in tretje stopnje, povezanih z zdravljenjem z lakozamidom.
English: Your doctor may then increase your twice daily dose every week by 1 mg (0.1 ml), for each kg of your body weight.
Slovenian: Zdravnik bo lahko povečal dnevni odmerek, razdeljen na dva odmerka, vsak teden za 1 mg (0,1 ml) za vsak kg vaše telesne mase.
English: Lacosamide UCB solution for infusion can be administered without further dilution, or may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) or lactated Ringer's solution.
Slovenian: Zdravilo Lakozamid UCB raztopina za infundiranje boste lahko prejeli brez predhodnega redčenja ali pa bo zdravilo prej razredčeno z eno od naslednjih raztopin: raztopina natrijevega klorida 9 mg/ml (0,9 %), raztopina glukoze 50 mg/ml (5 %) ali raztopina Ringerjevega laktata.
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).
Slovenian: Vsaka graduacijska oznaka (5 ml) merice ustreza 50 mg lakozamida (na primer 2 graduacijski oznaki ustrezata 100 mg).
English: Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day).
Slovenian: Glede na odziv posameznega bolnika in njegovo prenašanje zdravila se lahko vzdrževalni odmerek nadalje poveča v tedenskih intervalih za 50 mg dvakrat na dan (100 mg/dan) do največjega priporočenega dnevnega odmerka 300 mg dvakrat na dan (600 mg/dan).
English: In interaction trials lacosamide did not significantly affect the plasma concentrations of carbamazepine and valproic acid.
Slovenian: V preskušanjih medsebojnega delovanja z drugimi zdravili, lakozamid ni pomembno vplival na plazemske koncentracije karbamazepina in valprojske kisline, prav tako ob uporabi karbamazepina in valprojske kisline plazemske koncentracije lakozamida niso bile spremenjene.
English: Sleepiness, tiredness or weakness (asthenia);
Slovenian: • zaspanost, utrujenost ali slabo počutje (astenija);
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).
Slovenian: Ena graduacijska oznaka (5 ml) na 30 ml merici ustreza 50 mg lakozamida (npr. 2 graduacijski oznaki ustrezata 100 mg).
English: Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg (200 mg twice a day).
Slovenian: Glede na odziv posameznega bolnika in njegovo prenašanje zdravila lahko vzdrževalni odmerek povečujemo v tedenskih intervalih po 50 mg dvakrat na dan (100 mg/dan) do največjega priporočenega dnevnega odmerka 400 mg (200 mg dvakrat na dan).
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.
Slovenian: • Zdravilo Lakozamid UCB 10 mg/ml sirup je rahlo viskozna, bistra tekočina brezbarvne do rumeno-rjave barve.
English: (1) Children and adolescents less than 50 kg should preferably start the treatment with Lacosamide UCB 10 mg/ml syrup.
Slovenian: (1) Otroci in mladostniki, ki tehtajo manj kot 50 kg, naj zdravljenje po možnosti začnejo z zdravilom Lakozamid UCB 10 mg/ml sirup.
English: In children weighing less than 20 kg, due to an increased clearance compared to adults, a maximum dose of up to 12 mg/kg/day is recommended.
Slovenian: Pri otrocih, ki tehtajo manj kot 20 kg, je zaradi povečanega očistka v primerjavi z odraslimi, priporočen največji odmerek 12 mg/kg/dan.
English: 1 vial of 20 ml contains 200 mg lacosamide.
Slovenian: 1 viala po 20 ml vsebuje 200 mg lakozamida.
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.
Slovenian: Preobčutljivostne reakcije, kjer je prizadetih več organskih sistemov hkrati Pri bolnikih, ki so se zdravili z nekaterimi antiepileptiki, so poročali o preobčutljivostnih reakcijah, ki so prizadele več organskih sistemov hkrati (znanih tudi kot reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS).
English: One tablet of Lacosamide UCB 200 mg contains 200 mg lacosamide.
Slovenian: Ena tableta zdravila Lakozamid UCB 200 mg vsebuje 200 mg lakozamida.
English: Week 2
Slovenian: DRUGI PODATKI 2. teden
English: Only clear solution free from particles and discoloration should be used.
Slovenian: Uporablja se lahko samo raztopina brez delcev, ki ni spremenila barve.
English: Each package has 14 tablets, corresponding to 2 tablets per day for 7 days.
Slovenian: Vsako pakiranje ima 14 tablet, kar zadostuje za 7 dni jemanja po 2 tableti na dan. Vsako pakiranje vsebuje drugo jakost zdravila Lakozamid UCB, tako da boste odmerek povečevali postopno.