natgillin/translations-raw huggingface dataset:
Studies in animals did not indicate any teratogenic effects in rats or rabbits, but embyrotoxicity was observed in rats and rabbits at maternal toxic doses (see section 5.3).
Študije na živalih niso pokazale teratogenih učinkov pri podganah ali kuncih, vendar so pri podganah in kuncih opazili embriotoksičnost pri odmerkih, ki so bili toksični tudi za mater (glejte poglavje 5. 3).
Lactation It is unknown whether lacosamide is excreted in human breast milk.
Dojenje Ni znano, ali se lakozamid izloča v materino mleko.
Animal studies have shown excretion of lacosamide in breast milk.
Študije na živalih so pokazale, da se lakozamid izloča v mleko samic.
Vimpat may have minor to moderate influence on the ability to drive and use machines.
Zdravilo Vimpat ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Vimpat treatment has been associated with dizziness or blurred vision.
Zdravljenje z zdravilom Vipmat lahko povzroči omotico ali zamegljen vid.
Accordingly, patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of Vimpat on their ability to perform such activities.
V skladu s tem je treba bolnikom svetovati, da ne vozijo avtomobila ali upravljajo z drugimi potencialno nevarnimi stroji, dokler niso seznanjeni z učinki zdravila Vimpat na njihovo sposobnost izvajanja omenjenih aktivnosti.
Based on the analysis of pooled placebo-controlled clinical trials 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.
Na osnovi analiz združenih, s placebom nadzorovanih kliničnih preskušanj na 1. 308 bolnikih s
The most frequently reported adverse reactions with
4 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.
4 lacosamide treatment were dizziness, headache, nausea and diplopia.
Neželeni učinki, o katerih so pri zdravljenju z lakozamidom najpogosteje poročali, so bili omotica, glavobol, slabost in dvojni vid.
Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time.
Incidenca in resnost neželenih učinkov, povezanih z osrednjim živčnim sistemom in prebavili, sta se običajno s časom zmanjševali.
Over all 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.
V vseh nadzorovanih študijah je zaradi neželenih učinkov zdravljenje prekinilo 12, 2% bolnikov, ki so randomizirano jemali lakozamid, in 1, 6% bolnikov, ki so randomizirano jemali placebo.
The table below shows the frequencies of adverse reactions which have been reported in pooled placebo-controlled clinical trials.
Spodnja preglednica prikazuje pogostnost neželenih učinkov, o katerih so poročali v združenih, s placebom nadzorovanih kliničnih preskušanjih.
The frequencies are defined as follows: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100).
Pogostnost je navedena kot: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100).
Depression
depresija motnje ravnotežja
Balance disorder Coordination abnormal Memory impairment Cognitive disorder Somnolence Tremor Nystagmus
težave s koordinacijo motnje spomina kognitivna motnja zaspanost tremor nistagmus
Diplopia
diplopija
Vision blurred Vertigo
zamegljen vid vrtoglavica
Vomiting Constipation Flatulence
bruhanje zaprtost flatulenca
General disorders and administration site conditions Injury, poisoning and procedural complications
Splošne težave in spremembe na mestu aplikacije Poškodbe, zastrupitve in zapleti pri posegih
Gait disturbance Asthenia Fatigue Fall Skin laceration
težave pri hoji astenija utrujenost padec kožna laceracija
The use of lacosamide is associated with dose-related increase in the PR interval.
Uporaba lakozamida je povezana s podaljšanjem intervala P- R, ki je odvisno od odmerka.
Adverse reactions associated with PR interval prolongation (e. g. atrioventricular block, syncope, bradycardia) may occur.
Pojavijo se lahko neželeni učinki, povezani s podaljšanjem intervala P- R (npr. atrioventrikularni blok, sinkopa, bradikardija).
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.
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.
No second or higher degree AV Block was seen in lacosamide treated patients.
Pri bolnikih, ki so se zdravili z lakozamidom, se atrioventrikularni blok druge ali višje stopnje ni pojavil.
The incidence rate for syncope is uncommon and did not differ between lacosamide treated epilepsy patients (0.1%) and placebo treated epilepsy patients (0.3%).
Glede na incidenco je bila sinkopa opredeljena kot občasen neželeni učinek, incidenci pa se med bolniki z epilepsijo, ki se zdravijo z lakozamidom (0, 1%), in bolniki z epilepsijo, ki prejemajo placebo (0, 3%), nista razlikovali.
There is limited clinical experience with lacosamide overdose in humans.
Pri ljudeh so klinične izkušnje s prevelikim odmerjanjem lakozamida omejene.
Clinical symptoms (dizziness and nausea) following doses of 1200 mg/ day were mainly related to the central nervous system and the gastrointestinal system and resolved with dose adjustments.
Klinični simptomi (omotica in slabost) pri odmerkih 1200 mg/ dan so bili povezani predvsem z osrednjim živčnim sistemom in prebavili ter so po ustrezni prilagoditvi odmerka izginili.
The highest reported overdose in the clinical development program for lacosamide was 12 g taken in conjunction with toxic doses of multiple other antiepileptic drugs.
Največji odmerek, o katerem so poročali v programu kliničnega razvoja zdravila, je bil 12 g
The subject was initially comatose and then fully recovered without permanent sequelae.
Bolnik je bil v začetku komatozen, vendar si je popolnoma opomogel brez trajnih posledic.
There is no specific antidote for overdose with lacosamide.
Za preveliko odmerjanje lakozamida ni na voljo specifičnega antidota.
Treatment of lacosamide overdose should include general supportive measures and may include haemodialysis if necessary (see section 5.2).
Zdravljenje prevelikega odmerjanja lakozamida mora vključevati splošne podporne ukrepe, po potrebi lahko tudi dializo (glejte poglavje 5. 2).
Pharmacotherapeutic group: other antiepileptics, ATC code:
Farmakoterapevtske skupina: drugi antiepileptiki, oznaka ATC:
N03AX18 The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a functionalised amino acid.
N03AX18 Zdravilna učinkovina lakozamid (R- 2- acetamido- N- benzil- 3- metoksipropionamid) je delujoča aminokislina.
Mechanism of action The precise mechanism by which lacosamide exerts its antiepileptic effect in humans remains to be fully elucidated.
Mehanizem delovanja Natančen mehanizem, preko katerega lakozamid doseže svoj antiepileptični učinek pri ljudeh, še ni natančno pojasnjen.
Two observations that may be of relevance for the observed therapeutic effects are:
Dve opažanji, ki sta morda pomembni za opažene terapevtske učinke, sta:
In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes.
In vitro elektrofiziološke študije so pokazale, da lakozamid selektivno poveča počasno aktivacijo napetostnih natrijevih kanalčkov, kar vodi do stabilizacije hiperekscitabilnih nevronskih membran.
Further, lacosamide binds to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein which is mainly expressed in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth.
Poleg tega se lakozamid veže na kolapsin odzivni mediatorski protein 2 (CRMP- 2), fosfoprotein, ki se izraža predvsem v živčevju in sodeluje pri diferenciaciji nevronov in nadzoruje pretirano rast aksonov.
Pharmacodynamic effects Lacosamide protected against seizures in a broad range of animal models of partial and primary generalized seizures and delayed kindling development.
Farmakodinamični učinki Na širokem spektru živalskih modelov s parcialnimi in primarnimi generaliziranimi napadi so pokazali, da lakozamid varuje pred epileptičnimi napadi in zakasni razvoj epileptogenih sprememb.
Clinical experience The efficacy of Vimpat 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.
Klinične izkušnje Učinkovitost zdravila Vimpat kot dodatnega zdravljenja 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.
Vimpat 600 mg/ day was also shown to be effective in controlled adjunctive therapy trials, although the efficacy was similar to 400 mg/ day and patients were less likely to tolerate this dose because of CNS- and gastrointestinal-related adverse reactions.
Zdravilo Vimpat v odmerku 600 mg/ dan je bilo v nadzorovanem dodatnem zdravljenju učinkovito, vendar je bila učinkovitost podobna kot pri odmerku 400 mg/ dan.
Thus, the 600 mg/ day dose is not recommended.
Bolniki so odmerek 600 mg/ dan slabše prenašali zaradi neželenih učinkov, povezanih z osrednjim živčnim sistemom in prebavili, zato odmerek 600 mg/ dan ni priporočljiv.
The maximum recommended dose is 400 mg/ day.
Največji priporočeni odmerek je zato 400 mg/ dan.
These trials, involving 1308 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 drugs in patients with uncontrolled partial-onset seizures with or without secondary generalisation.
Preskušanja, v katera je bilo vključenih 1. 308 bolnikov, ki so imeli po 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.
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.
V celoti je bil delež bolnikov, pri katerih se je pogostnost napadov zmanjšala za 50%, 23% pri placebu, 34% pri bolnikih, ki so jemali lakozamid v odmerku 200 mg/ dan, in 40% pri bolnikih, ki so jemali lakozamid v odmerku 400 mg/ dan.
There are insufficient data regarding the withdrawal of concomitant antiepileptic medicinal products to achieve monotherapy with lacosamide.
Za doseganje monoterapije z lakozamidom ni na voljo zadostnih podatkov o prekinitvi zdravljenja z drugimi antiepileptiki, ki jih bolnik jemlje sočasno.
Absorption Lacosamide is rapidly and completely absorbed after oral administration.
Absorpcija Lakozamid se po peroralni aplikaciji hitro in popolnoma absorbira.
The oral bioavailability of lacosamide tablets is approximately 100%.
Biološka uporabnost tablet lakozamida po peroralni uporabi je približno 100%.
Following oral administration, the plasma concentration of unchanged lacosamide increases rapidly and reaches Cmax about 0.5 to 4 hours post-dose.
Po peroralni aplikaciji se plazemska koncentracija nespremenjenega lakozamida hitro poveča in doseže Cmax okoli 0, 5 do 4 ure po odmerku.
Vimpat tablets and oral syrup are bioequivalent.
Tablete in peroralni sirup zdravila Vimpat sta bioekvivalentna.
Distribution The volume of distribution is approximately 0.6 L/ kg.
6 Volumen porazdelitve je približno 0, 6 L/ kg.
Lacosamide is less than 15% bound to plasma proteins.
Na plazemske beljakovine se veže manj kot 15% lakozamida.
Metabolism 95% of the dose is excreted in the urine as drug and metabolites.
Presnova 95% odmerka se izloči s sečem v obliki nespremenjenega zdravila in njegovih presnovkov.
The major compounds excreted in urine are unchanged lacosamide (approximately 40% of the dose) and its O-desmethyl metabolite less than 30%.
Glavni spojini, ki se izločata s sečem, sta nespremenjeni lakozamid (približno 40% odmerka) in njegov O- demetilni presnovek (manj kot 30%).
A polar fraction proposed to be serine derivatives accounted for approximately 20% in urine, but was detected only in small amounts (0-2%) in human plasma of some subjects.
Polarna frakcija, ki jo verjetno sestavljajo derivati serina, predstavlja približno 20% odmerka, izločenega s sečem, v človeški plazmi pa so jo v majhnih količinah (0 – 2%) določili pri nekaterih preiskovancih.
Small amounts (0.5-2%) of additional metabolites were found in the urine.
V seču so našli tudi majhne količine (0, 5 – 2%) drugih presnovkov.
However, no
Za tvorbo O- demetilnega presnovka je odgovoren predvsem CYP2C19.
6 clinically relevant difference in lacosamide exposure was observed comparing its pharmacokinetics in extensive metabolisers (EMs, with a functional CYP2C19) and poor metabolisers (PMs, lacking a functional CYP2C19).
Vendar pri primerjavi farmakokinetike preiskovancev s hitro (funkcionalen encim CYP2C19) in počasno presnovo (pomanjkanje funkcionalnega encima CYP2C19) niso opazili klinično pomembnih razlik v izpostavljenosti lakozamidu.
No other enzymes have been identified to be involved in the metabolism of lacosamide.
Identificirali niso nobenih drugih encimov, vključenih v presnovo lakozamida.
The plasma concentration of O-desmethyl-lacosamide is approximately 15% of the concentration of lacosamide in plasma.
Plazemska koncentracija O- demetil- lakozamida predstavlja približno 15% plazemske koncentracije lakozamida.
Elimination Lacosamide is primarily eliminated from the systemic circulation by renal excretion and biotransformation.
Izločanje Lakozamid se primarno iz sistemskega krvnega obtoka izloča z ledvično ekskrecijo in biotransformacijo.
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 feces.
Po peroralni in intravenski aplikaciji radioaktivno označenega lakozamida so približno 95% radioaktivnosti zaznali v seču in manj kot 0, 5% v blatu.
The pharmacokinetics is dose-proportional and constant over time, with low intra- and inter-subject variability.
Farmakokinetika je sorazmerna z odmerkom in časovno konstantna, z nizko intra - in interindividualno variabilnostjo.
Following twice daily dosing, steady state plasma concentrations are achieved after a 3 day period.
Pri dvakrat dnevnem odmerjanju dosežemo plazemske koncentracije v stanju dinamičnega ravnovesja po 3 dneh.
The plasma concentration increases with an accumulation factor of approximately 2.
Plazemska koncentracije narašča s faktorjem akumulacije približno 2.
Pharmacokinetics in special patient groups Gender Clinical trials indicate that gender does not have a clinically significant influence on the plasma concentrations of lacosamide.
Farmakokinetika pri posebnih skupinah bolnikov Spol Klinična preskušanja kažejo, da spol nima klinično pomembnega vpliva na plazemske koncentracije lakozamida.
Renal impairment The AUC of lacosamide was increased by approximately 30% in mildly and moderately and 60% in severely renal impaired patients and patients with endstage renal disease requiring hemodialysis compared to healthy subjects, whereas cmax was unaffected.
Ledvična okvara 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%.
Therefore dosage supplementation following haemodialysis is recommended (see section 4.2).
Po 4- urni dializi se AUC lakozamida zmanjša za približno 50%, zato je po dializi priporočljivo dodatno odmerjanje zdravila (glejte poglavje 4. 2).
The exposure of the O-desmethyl metabolite was several-fold increased in patients with moderate and severe renal impairment.
Pri bolnikih z zmerno do hudo ledvično okvaro se je izpostavljenost O- demetilnemu presnovku nekajkrat povečala.
In absence of haemodialysis in patients with endstage renal disease, the levels were increased and continuously rising during the 24-hour sampling.
Če bolniki s končno ledvično odpovedjo niso na dializi, se njihove koncentracije povečujejo in med 24- urnim vzorčenjem vztrajno rastejo.
It is unknown whether the increased metabolite exposure in endstage renal disease subjects could give rise to adverse effects but no pharmacological activity of the metabolite has been identified.
Ni znano, ali povečana izpostavljenost presnovku pri bolnikih s končno ledvično odpovedjo vodi tudi do povečanja neželenih učinkov, čeprav niso opazili farmakološke aktivnosti presnovkov.
Hepatic impairment Subjects with moderate hepatic impairment (Child-Pugh B) showed higher plasma concentrations of lacosamide (approximately 50% higher AUCnorm).
Jetrna okvara Plazemske koncentracije lakozamida so bile pri bolnikih z zmerno jetrno okvaro (Child- Pugh B) povečane (približno 50% večje kot AUCnorm).
The decrease in non-renal clearance in the patients of the study was estimated to give a 20% increase in the AUC of lacosamide.
Ocenjujejo, da je zmanjšanje neledvičnega očistka pri bolnikih v študiji povzročilo 20% povečanje AUC lakozamida.
The pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment (see section 4.2).
Farmakokinetike lakozamida niso ovrednotili pri bolnikih s hudo jetrno okvaro (glejte poglavje 4. 2).
Elderly (over 65 years of age) In a study in elderly men and women including 4 patients > 75 years of age, AUC was about 30 and 50% increased compared to young men, respectively.
Starejši bolniki (starejši od 65 let) V študiji pri starejših moških in ženskah, v kateri so sodelovali tudi 4 bolniki, starejši od 75 let, je bila AUC v primerjavi z mladimi moškimi povečana za 30 oz.
This is partly related to lower body weight.
50%, kar je deloma povezano z manjšo 7 telesno maso.
The body weight normalized difference is 26 and 23%, respectively.
Normalizirana razlika telesne mase je bila 26% pri moških in 23% pri ženskah.
An increased variability in exposure was also observed.
Opazili so tudi povečano variabilnost v izpostavljenosti.
A general dose reduction is not considered to be necessary unless indicated due to reduced renal function (see section 4.2).
Splošno zmanjševanje odmerka ni potrebno, razen če je to indicirano zaradi zmanjšanega delovanja ledvic (glejte poglavje 4. 2).
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
V študijah toksičnosti so bile plazemske koncentracije lakozamida podobne ali le mejno povečane glede na koncentracije, ki so jih opazili pri bolnikih, kar dovoljuje majhne ali neobstoječe mejne vrednosti izpostavljenosti pri človeku.
7 exposure 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.
Študije farmakološke varnosti pri intravenski aplikaciji lakozamida anesteziranim psom so pokazale prehodno podaljšanje intervala P- R in trajanje kompleksa Q- R- S ter zmanjšanje krvnega tlaka, najverjetneje zaradi zaviralnega delovanja na srce.
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.
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.
In the repeated dose toxicity studies, mild reversible liver changes were observed in rats starting at about 3 times the clinical exposure.
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.
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.
V študijah vplivov na sposobnost razmoževanja in toksičnosti za razvoj zarodka pri glodavcih in kuncih niso pri za samico podgane toksičnih odmerkih, ki ustrezajo sistemski izpostavljenosti, podobni pričakovani klinični izpostavljenosti, opazili teratogenih učinkov, prišlo pa je do povečanja števila mrtvorojenih mladičev in smrti mladičev v peripartalnem obdobju ter do nekoliko zmanjšanega števila živega zaroda in telesne mase mladičev.
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.
Ker pri živalih niso mogli preučevati večjih stopenj izpostavljenosti zaradi toksičnosti za samico, so podatki nezadostni za popolno opredelitev embriofeto- toksičnega in teratogenega potenciala lakozamida.
Studies in rats revealed that lacosamide and/ or its metabolites readily crossed the placental barrier.
Študije pri podganah so pokazale, da lakozamid in/ ali njegovi presnovki brez težav prehajajo placento.
Tablet core: microcrystalline cellulose hydroxypropylcellulose hydroxypropylcellulose (low substituted) silica, colloidal, anhydrous crospovidone magnesium stearate
Mikrokristalna celuloza hidroksipropilceluloza hidroksipropilceluloza (delno substituirana) silicijev dioksid, koloidni, brezvodni krospovidon magnezijev stearat
Tablet coat: polyvinyl alcohol polyethylene glycol 400, 3350 and 8000 talc soya-lecithin hypromellose titanium dioxide (E171) red iron oxide (E172), black iron oxide (E172), indigo carmine aluminium lake (E132)
Obloga tablete: polivinilalkohol polietilenglikol 400, 3350 in 8000 smukec sojin lecitin hipromeloza titanov dioksid (E171) rdeči železov oksid (E172), črni železov oksid (E172), indigotin (E132)
6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevenje
PVC/ PVDC blister sealed with an aluminium foil.
PVC/ PVDC pretisni omot, pokrit z aluminijasto folijo.
8 Packs of 14, 56 and 168 film-coated tablets.
Pakiranja po 14, 56 in 168 filmsko obloženih tablet
UCB Pharma SA Allée de la Recherche 60 B-1070 Bruxelles Belgium
UCB Pharma SA Allée de la Recherche 60 B- 1070 Bruxelles Belgija
Date of first authorisation:
29.
29 August 2008
2008
Each film-coated tablet contains 0.34 mg soya-lecithin.
Ena filmsko obložena tableta vsebuje 0, 34 mg sojinega lecitina.
Film-coated tablet Dark yellow, oval film-coated tablet debossed with ‘ SP’ on one side and ‘ 100’ on the other side.
Filmsko obložena tableta Temno rumena, ovalna filmsko obložena tableta z vtisnjeno oznako ‘ SP ’ na eni strani in oznako ‘ 100 ’ na drugi strani.
10 5.2).
10 Izkušnje z uporabo lakozamida pri starejših bolnikih z epilepsijo so omejene.
Antiepileptic drugs In interaction trials lacosamide did not significantly affect the plasma concentrations of carbamazepine and valproic acid.
Antiepileptiki
11 valproic acid.
11 V preskušanjih medsebojnega delovanja z drugimi zdravili lakozamid ni pomembno vplival na plazemske koncentracije karbamazepina in valprojske kisline, prav tako pa niso bile ob uporabi karbamazepina in valprojske kisline spremenjene plazemske koncentracije lakozamida.