FrancophonIA/ELRC3.0 huggingface dataset:
English: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF United Kingdom or
Slovenian: Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Združeno kraljestvo ali
English: Dosage in adolescents and children weighing 50 kg or more is the same as in adults (see above).
Slovenian: Odmerek pri mladostnikih in otrocih, ki tehtajo 50 kg ali več, je enak kot pri odraslih (glejte zgoraj).
English: • Lacosamide Accord is used in adults, adolescents and children aged 4 years and older.
Slovenian: • Zdravilo Lacosamide Accord se uporablja pri odraslih, mladostnikih in otrocih, starih 4 leta in več.
English: What you need to know before you take Lacosamide Accord
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Lacosamide Accord
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: • medicines for fungal infections called fluconazole, itraconazole or ketoconazole;
Slovenian: • zdravila za glivične okužbe, ki se imenujejo flukonazol, itrakonazol ali ketokonazol;
English: Lacosamide Accord film-coated tablets are packed in PVC-PVDC/Aluminium blisters.
Slovenian: Zdravilo Lacosamide Accord filmsko obložene tablete je pakirano v PVC-PVDC/aluminijastih pretisnih omotih.
English: • If you have missed a dose beyond the first 6 hours of the scheduled dose, do not take the missed tablet anymore.
Slovenian: • Če ste z odmerkom zamudili več kot 6 ur od predvidenega časa za odmerek, ne vzemite izpuščene tablete.
English: You will start your treatment with a low dose of Lacosamide Accord, usually 50 mg twice a day, and increase it week by week.
Slovenian: Zdravljenje boste začeli z nizkim odmerkom zdravila Lacosamide Accord, običajno 50 mg dvakrat na dan, in ga iz tedna v teden povečevali.
English: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona SPAIN
Slovenian: Laboratori Fundacio Dau C/ C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Španija
English: How to store Lacosamide Accord Contents of the pack and other information
Slovenian: Shranjevanje zdravila Lacosamide Accord Vsebina pakiranja in dodatne informacije
English: It is not recommended to take Lacosamide Accord if you are pregnant or breast-feeding, as the effects of lacosamide on pregnancy and the unborn baby or the new-born child are not known.
Slovenian: V času nosečnosti ali dojenja jemanje zdravila Lacosamide Accord ni priporočljivo, ker učinki lakozamida na nosečnost, nerojenega otroka ali novorojenega otroka niso znani.
English: Lacosamide Accord is available in packs of 14, 56, 60 or 168 film-coated tablets.
Slovenian: Zdravilo Lacosamide Accord filmsko obložene tablete je na voljo v pakiranjih po 14, 56, 60 ali 168 filmsko obloženih tablet.
English: • If your doctor decides to stop your treatment with Lacosamide Accord , they will tell you how to decrease the dose step by step.
Slovenian: • Če se bo zdravnik odločil za prekinitev zdravljenja z zdravilom Lacosamide Accord, vam bodo povedali, kako po korakih zmanjševati odmerek.
English: 50 mg: Each film-coated tablet contains 0.105 mg of lecithin (soya) 100 mg: Each film-coated tablet contains 0.210 mg of lecithin (soya) 150 mg: Each film-coated tablet contains 0.315 mg of lecithin (soya) 200 mg: Each film-coated tablet contains 0.420 mg of lecithin (soya) For the full list of excipients, see section 6.1.
Slovenian: 50 mg: ena filmsko obložena tableta vsebuje 0,105 mg lecitina (soja) 100 mg: ena filmsko obložena tableta vsebuje 0,210 mg lecitina (soja) 150 mg: ena filmsko obložena tableta vsebuje 0,315 mg lecitina (soja) 200 mg: ena filmsko obložena tableta vsebuje 0,420 mg lecitina (soja) Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Your doctor may also prescribe a starting dose of 100 mg of Lacosamide Accord twice a day.
Slovenian: Zdravnik vam lahko predpiše tudi začetni odmerek 100 mg zdravila Lacosamide Accord dvakrat na dan.
English: The efficacy of lacosamide as adjunctive therapy at recommended doses (200 mg/day, 400 mg/day) was established in 3 multicenter, randomized, placebo-controlled clinical trials with a 12-week maintenance period.
Slovenian: Učinkovitost dopolnilnega zdravljenja z lakozamidom v priporočenih odmerkih (200 mg/dan, 400 mg/dan) so preučevali v 3 multicentričnih, randomiziranih, s placebom nadzorovanih kliničnih preskušanjih z 12-tedenskim obdobjem vzdrževalnega zdravljenja.
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.
Slovenian: Preskušanja, v katera je bilo vključenih 1308 bolnikov, ki so imeli v anamnezi parcialne napade v povprečju 23 let, so bila načrtovana za oceno učinkovitosti in varnosti lakozamida pri sočasnem jemanju z 1 do 3 antiepileptiki pri bolnikih z nenadzorovanimi parcialnimi napadi s sekundarno generalizacijo ali brez nje.
English: Table: Start of the treatment (the first 4 weeks)
Slovenian: Preglednica: Začetek zdravljenja (prvi 4 tedni)
English: In anesthetized dogs and Cynomolgus monkeys, at intravenous doses of 15-60 mg/kg, slowing of atrial and ventricular conductivity, atrioventricular block and atrioventricular dissociation were seen.
Slovenian: Pri anesteziranih psih in opicah vrste Cynomolgus so pri intravenskih odmerkih 15-60 mg/kg opazili zmanjšanje atrijske in ventrikularne prevodnosti, atrioventrikularni blok in atrioventrikularno disociacijo.
English: WESSLING Hungary Kft, Anonymus u. 6., Budapest, 1045, Hungary
Slovenian: WESSLING Hungary Kft, Anonymus u. 6., Budapest, 1045, Madžarska
English: A safety pharmacology study with intravenous administration of lacosamide in anesthetized dogs showed transient increases in PR interval and QRS complex duration and decreases in blood pressure most likely due to a cardiodepressant action.
Slovenian: Študije farmakološke varnosti pri intravenski uporabi lakozamida anesteziranim psom so pokazale prehodno podaljšanje intervala P-R in trajanje kompleksa Q-R-S ter znižanje krvnega tlaka, najverjetneje zaradi zaviralnega delovanja na srce.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Lacosamide Accord.
Slovenian: Če za vas velja kar koli od zgoraj navedenega (ali če o tem niste prepričani), se pred jemanjem zdravila Lacosamide Accord posvetujte z zdravnikom ali farmacevtom.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Lacosamide Accord Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: • dizziness;
Slovenian: • omotica;
English: LABORATORI FUNDACIÓ DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040 Barcelona, Spain or
Slovenian: LABORATORI FUNDACIÓ DAU C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040 Barcelona, Španija ali
English: The efficacy and safety of lacosamide in conversion to monotherapy has been assessed in a historicalcontrolled, multicentre, double-blind, randomized trial.
Slovenian: Učinkovitost in varnost lakozamida pri prehodu na samostojno zdravljenje je bila ocenjena iz preteklega nadzorovanega, multicentričnega, dvojno slepega, randomiziranega preskušanja.
English: After oral and intravenous administration of radiolabeled lacosamide, approximately 95% of radioactivity administered was recovered in the urine and less than 0.5% in the faeces.
Slovenian: Po peroralni in intravenski aplikaciji radioaktivno označenega lakozamida so približno 95 % radioaktivnosti zaznali v seču in manj kot 0,5 % v blatu.
English: • medicines used to treat bacterial infections called clarithromycin or rifampicin;
Slovenian: • zdravila, ki se uporabljajo za zdravljenje bakterijskih okužb, imenovana klaritromicin ali rifampicin;
English: However, a higher incidence (≥5 % difference) of fall, diarrhoea and tremor has been reported in elderly patients compared to younger adult patients.
Slovenian: Vendar pa so pri starejših bolnikih poročali o višji incidenci (≥ 5 % razlika) padcev, diareje in tremorja v primerjavi z mlajšimi odraslimi bolniki.
English: The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in openlabel studies (n=408) in adjunctive therapy in children from 4 years of age was consistent with the safety profile observed in adults although the frequency of some adverse reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions (nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %).
Slovenian: Varnostni profil lakozamida v študijah, nadzorovanih s placebom (glejte podrobnosti o študiji v poglavju 5.1), in v odprtih študijah (n = 408) pri dopolnilnem zdravljenju pri otrocih od 4 leta starosti, je bil skladen z varnostnim profilom opaženim pri odraslih, čeprav se je pogostnost nekaterih neželenih učinkov (zaspanost, bruhanje in konvulzije) povečala in so pri pediatričnih bolnikih poročali o dodatnih neželenih učinkih, (nazofaringitis, pireksija, faringitis, zmanjšan apetit, letargičnost in nenormalno vedenje): nazofaringitis (15,7 %), bruhanje (14,7 %), zaspanost (14,0 %), omotica (13,5 %), pireksija (13,0 %), konvulzije (7,8 %), zmanjšan apetit (5,9 %), faringitis (4,7 %), letargija (2,7 %) in nenormalno vedenje (1,7 %).
English: Outer carton - treatment initiation pack containing 4 cartons of 14 film-coated tablets
Slovenian: SAMO ZA PAKIRANJE ZA ZAČETEK ZDRAVLJENJA Zunanja škatla - pakiranje za začetek zdravljenja vsebuje 4 škatlice po 14 filmsko obloženih tablet
English: The patients were randomized to carbamazepine CR or lacosamide, provided as tablets, in a 1:1 ratio.
Slovenian: Bolniki so randomizirano prejemali karbamazepin z nadzorovanim sproščanjem ali lakozamid v obliki tablet, v razmerju 1:1.
English: What Lacosamide Accord is and what it is used for
Slovenian: Kaj je zdravilo Lacosamide Accord in za kaj ga uporabljamo
English: The treatment initiation pack contains 4 cartons, each carton with 14 tablets of 50 mg, 100 mg, 150 mg and 200 mg.
Slovenian: Vsaka škatla vsebuje 14 tablet po 50 mg, 100 mg, 150 mg in 200 mg.
English: 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: 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: 08039 Barcelona, Spain
Slovenian: 08040 Barcelona, Španija ali
English: Convulsion.
Slovenian: • konvulzije.
English: PC:
Slovenian: PC: {številka}
English: If you are taking Lacosamide Accord and you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek medical advice immediately (see section 4).
Slovenian: Če jemljete zdravilo Lacosamide Accord in se pojavijo simptomi nepravilnega srčnega utripa (kot so počasen, hiter ali nepravilen srčni utrip, palpitacije, zasoplost, občutek vrtoglavice, omedlevica), takoj poiščite zdravniško pomoč (glejte poglavje 4).
English: In this study, 425 patients aged 16 to 70 years with uncontrolled partial-onset seizures taking stable doses of 1 or 2 marketed antiepileptic medicinal products were randomized to be converted to lacosamide monotherapy (either 400mg/day or 300mg/day in a 3:1 ratio).
Slovenian: V tej študiji je bilo 425 bolnikov, starih od 16 do 70 let, z nenadzorovanimi parcialnimi napadi, ki so jemali stabilne odmerke 1 ali 2 antiepileptikov, randomizirano za prehod na samostojno zdravljenje z lakozamidom (bodisi 400 mg/dan ali 300 mg/dan, v razmerju 3:1).
English: • It is used to treat a certain type of epilepsy characterised by the occurrence of partial-onset seizure with or without secondary generalisation.
Slovenian: • Zdravilo Lacosamide Accord se uporablja za zdravljenje določene vrste epilepsije, za katero so značilni parcialni napadi s sekundarno generalizacijo ali brez nje.
English: If you weigh 50 kg or more, your doctor may decide to start Lacosamide Accord treatment with a single “loading” dose of 200 mg. You would then start your ongoing maintenance dose 12 hours later.
Slovenian: Če tehtate 50 kg ali več, se lahko zdravnik odloči, da začne zdravljenje z zdravilom Lacosamide Accord z enkratnim začetnim “polnilnim” odmerkom 200 mg.
English: Also, it is not known whether Lacosamide Accord passes into the breast milk.
Slovenian: Prav tako ni znano, ali zdravilo Lacosamide Accord prehaja v materino mleko.
English: • fits (seizures), heart beat problems such as a slow, fast or irregular heart beat , coma or a fall in blood pressure with rapid heartbeat and sweating.
Slovenian: • napadi (krči), težave s srčnim ritmom, kot je počasen, hiter ali nereden srčni utrip, koma ali padec krvnega tlaka s hitrim bitjem srca in znojenjem.
English: Atrioventricular block(1,2)
Slovenian: Srčne bolezni atrioventrikularni blok(1,2)
English: Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia); A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis);
Slovenian: • široko razširjen izpuščaj z mehurčki in luščenjem kože še posebej okoli ust, nosu, oči in v predelu spolovil (Stevens-Johnsonov sindrom) in bolj huda oblika, ki povzroči luščenje kože na več kot 30 % telesne površine (toksična epidermalna nekroliza);
English: 4.5 Interaction with other medicinal products and other forms of interaction 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 class I antiarrhythmics.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij 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: Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Lacosamide 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 lakozamid, in pri 0% (0/356) bolnikov, ki so jemali placebo.
English: Lacosamide Accord contains soya lecithin.
Slovenian: Zdravilo Lacosamide Accord vsebuje sojin lecitin.
English: When you take Lacosamide Accord with other antiepileptic medicines The usual starting dose of Lacosamide Accord is 50 mg twice a day.
Slovenian: Ko boste vzeli zdravilo Lacosamide Accord skupaj z drugimi antiepileptiki: Običajen začetni odmerek zdravila Lacosamide Accord je 50 mg dvakrat na dan.
English: The most frequently reported adverse reactions (≥10 %) with lacosamide treatment were dizziness, headache, nausea and diplopia.
Slovenian: Neželeni učinki, o katerih so pri zdravljenju z lakozamidom najpogosteje poročali (≥ 10 %), so bili omotica, glavobol, slabost in dvojni vid.
English: Lacosamide Accord is indicated as monotherapy and adjunctive therapy in the treatment of partialonset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Slovenian: Zdravilo Lacosamide Accord je indicirano za samostojno in dopolnilno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, mladostnikih in otrocih od 4. leta starosti z epilepsijo.
English: Nystagmus Hypoesthesia Dysarthria Disturbance in attention
Slovenian: nistagmus hipoestezija disartrija motnje pozornosti parestezija
English: Lacosamide Accord may make you dizzy -this could increase the risk of accidental injury or a fall.
Slovenian: Zdravilo Lacosamide Accord lahko povzroča omotico, kar lahko poveča tveganje za naključne poškodbe ali padce.
English: The usual starting dose of Lacosamide Accord is 50 mg twice a day.
Slovenian: Običajen začetni odmerek zdravila Lacosamide Accord je 50 mg dvakrat na dan.
English: Film-coat: Polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171), lecithin (soya) and colorants* * The colorants are
Slovenian: Obloga tablete: polivinilalkohol, polietilenglikol, smukec, titanov dioksid (E171), lecitin (sojin) in barvila* *Barvila so:
English: • Lacosamide Accord is used in adolescents and children aged 4 years and older weighing 50 kg or more and in adults.
Slovenian: • Zdravilo Lacosamide Accord se uporablja pri mladostnikih in otrocih, starih 4 leta ali več, ki tehtajo 50 kg ali več, in pri odraslih.
English: 100 mg/day or 200 mg/day
Slovenian: 100 mg/dan ali 200 mg/dan 100 mg/dan
English: The 14 x 1 or 56 x 1 tablet pack is available as perforated unit dose PVC-PVDC/Aluminium blisters sealed with an aluminium foil, all other packs are available with standard PVC-PVDC/Aluminium blisters sealed with an aluminium foil.
Slovenian: Pakiranje po 14 x 1 ali 56 x 1 tableta je na voljo v perforiranih PVC-PVDC/aluminijastih pretisnih omotih za enkratni odmerek, pokritih z aluminijasto folijo.
English: Irritability, trouble sleeping, depression;
Slovenian: razdražljivost, težave s spanjem, depresija; zaspanost, utrujenost, ali oslabelost (astenija); srbenje, izpuščaj;
English: Tablet core: Microcrystalline cellulose, hydroxy propyl cellulose-L, hydroxy propyl cellulose (low substituted), silica colloidal anhydrous, crospovidone and magnesium stearate.
Slovenian: Jedro tablete: mikrokristalna celuloza, hidroksipropilceluloza-L, hidroksipropilceluloza (delno substituirana), koloidni brezvodni silicijev dioksid, krospovidon in magnezijev stearat.
English: Based on the analysis of pooled placebo-controlled clinical trials in adjunctive therapy in 1,308 patients with partial-onset seizures, a total of 61.9 % of patients randomized to lacosamide and 35.2 % of patients randomized to placebo reported at least 1 adverse reaction.
Slovenian: Na osnovi analiz združenih, s placebom nadzorovanih kliničnih preskušanj pri dopolnilnem zdravljenju pri 1308 bolnikih s parcialnimi napadi, so vsaj o enem neželenem učinku poročali pri skupaj 61,9 % bolnikov, ki so randomizirano jemali lakozamid, in pri 35,2 % bolnikov, ki so randomizirano jemali placebo.
English: The oral bioavailability of lacosamide tablets is approximately 100%.
Slovenian: Biološka uporabnost tablet lakozamida po peroralni uporabi je približno 100 %.
English: Lacosamide Accord is indicated as monotherapy and adjunctive therapy in the treatment of partialonset seizures with or without secondary generalisation in adolescents and children from 4 years of age weighing 50 kg or more and in adults with epilepsy.
Slovenian: Zdravilo Lacosamide Accord je indicirano za samostojno in dopolnilno zdravljenje parcialnih napadov s sekundarno generalizacijo ali brez nje pri mladostnikih in otrocih od 4. leta starosti, ki tehtajo 50 kg ali več, in pri odraslih, z epilepsijo.
English: This is because Lacosamide Accord may make you feel dizzy or cause blurred vision.
Slovenian: Razlog za to je, da lahko zdravilo Lacosamide Accord povzroča omotico ali zamegljen vid.
English: Adolescents and children weighing 50 kg or more and adults When you take Lacosamide Accord on its own
Slovenian: Mladostniki in otroci, ki tehtajo 50 kg ali več, in odrasli Ko boste vzeli zdravilo Lacosamide Accord samostojno:
English: In vitro studies indicate that the enzymes CYP1A2, CYP2B6, and CYP2C9 are not induced and that CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP 2D6, 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: 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: Overall the proportion of subjects with a 50% reduction in seizure frequency was 23 %, 34 %, and 40 % for placebo, lacosamide 200 mg/day and lacosamide 400 mg/day.
Slovenian: V celoti je bil delež bolnikov, pri katerih se je pogostnost napadov zmanjšala za 50 %, pri placebu 23 %, pri bolnikih, ki so jemali lakozamid v odmerku 200 mg/dan, 34 % in pri bolnikih, ki so jemali lakozamid v odmerku 400 mg/dan, 40 %.
English: • feeling sick (nausea) or being sick (vomiting);
Slovenian: • siljenje na bruhanje (navzea) ali bruhanje;
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.
Slovenian: Na osnovi analize podatkov dobljenih pri kliničnem preskušanju ne-inferiornega samostojnega zdravljenja, kjer so primerjali lakozamid s karbamazepinom z nadzorovanim sproščanjem, sta bila glavobol in omotica neželena učinka, o katerih so pri lakozamidu najpogosteje poročali (≥ 10 %).
English: On the first day of treatment the patient starts with Lacosamide Accord 50 mg tablets twice a day.
Slovenian: Prvi dan zdravljenja začne bolnik z zdravilom Lacosamide Accord 50 mg tablete dvakrat na dan.
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 do 12 mg/kg/dan.
English: In all of these controlled studies, the discontinuation rate due to adverse reactions was 12.2 % for patients randomized to lacosamide and 1.6 % for patients randomized to placebo.
Slovenian: V vseh nadzorovanih študijah je zdravljenje zaradi neželenih učinkov prekinilo 12,2 % bolnikov, ki so randomizirano jemali lakozamid, in 1,6 % bolnikov, ki so randomizirano jemali placebo.
English: Paediatric population Adolescents and children weighing 50 kg or more
Slovenian: Pediatrična populacija Mladostniki in otroci, ki tehtajo 50 kg ali več
English: If you forget to take Lacosamide Accord
Slovenian: Če ste pozabili vzeti zdravilo Lacosamide Accord
English: Bradycardia(1,2) Atrial Fibrillation Atrial Flutter (1,2)
Slovenian: bradikardija(1,2) atrijska fibrilacija(1,2) atrijska undulacija(1,2)
English: Therefore, this medicinal product should be used with caution in patients allergic to peanut or soya.
Slovenian: Zdravilo Lacosamide Accord vsebuje sojin lecitin, zato je potrebna previdnost pri bolnikih, ki so alergični na arašide ali sojo.
English: Blister label - week 4
Slovenian: PRETISNI OMOT - 4. teden
English: If you stop taking Lacosamide Accord
Slovenian: Če ste prenehali jemati zdravilo Lacosamide Accord