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Lakozamid)
Presnova lakozamida ni popolnoma pojasnjena.
The metabolism of lacosamide has not been completely characterised.Tveganje, povezano z lakozamidom Ni zadostnih podatkov o uporabi lakozamida pri nosečnicah.
Risk related to lacosamide There are no adequate data from the use of lacosamide in pregnant women.Podatki o medsebojnem delovanju lakozamida z alkoholom niso na voljo.
No data on the interaction of lacosamide with alcohol are available.Pri ljudeh so klinične izkušnje s prevelikim odmerjanjem lakozamida omejene.
There is limited clinical experience with lacosamide overdose in humans.Izkušnje z uporabo lakozamida pri starejših bolnikih z epilepsijo so omejene.
The experience with lacosamide in elderly patients with epilepsy is limited.Iz previdnosti je treba v času zdravljenja z lakozamidom dojenje prekiniti.
For precautionary measures, breast-feeding should be discontinued during treatment with lacosamide.V kliničnih študijah so pri zdravljenju z lakozamidom opazili podaljšanje intervala P-R.
Prolongations in PR interval with lacosamide have been observed in clinical studies.Pri bolnikih s hudo okvaro jeter farmakokinetike lakozamida niso preučevali(glejte poglavje 5. 2.
The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients(see section 5.2.Zdravljenje z lakozamidom je povezano z omotico, kar lahko poveča pojav naključnih poškodb ali padcev.
Treatment with lacosamide has been associated with dizziness which could increase the occurrence of accidental injury or falls.Neželeni učinek, zaradi katerega so bolniki najpogosteje prekinili zdravljenje z lakozamidom, je bila omotica.
The most common adverse reaction resulting in discontinuation of lacosamide therapy was dizziness.Farmakokinetike lakozamida niso ovrednotili pri bolnikih s hudo jetrno okvaro(glejte poglavje 4. 2.
The pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment(see section 4.2.Čeprav farmakokinetičnih podatkov o medsebojnem delovanju lakozamida z alkoholom ni na voljo,
Although no pharmacokinetic data on the interaction of lacosamide with alcohol are available,Neželeni učinki, o katerih so pri zdravljenju z lakozamidom najpogosteje poročali,
The most frequently reported adverse reactions with lacosamide treatment were dizziness,izkušnje iz kliničnih preskušanj z dvakrat dnevnim infundiranjem lakozamida so za uporabo zdravila do 5 dni.
there is experience from clinical trials with twice daily infusions of lacosamide for up to 5 days.Ni znano, ali se lakozamid izloča v materino mleko.
It is unknown whether lacosamide is excreted in human breast milk.Antiepileptiki V preskušanjih medsebojnega delovanja z drugimi zdravili lakozamid ni pomembno vplival na.
Antiepileptic drugs In interaction trials lacosamide did not significantly affect the plasma concentrations of carbamazepine.Antiepileptiki V preskušanjih medsebojnega delovanja z drugimi zdravili lakozamid ni pomembno vplival na.
Antiepileptic drugs In interaction trials lacosamide did not significantly affect the plasma concentrations of carbamazepine and valproic acid.In vitro študija je pokazala, da se lakozamid v črevesju ne prenaša preko glikoproteina P.
An in vitro study indicated that lacosamide is not transported by P-glycoprotein in the intestine.NE jemljite zdravila Vimpat• če ste alergični na(preobčutljivi za) lakozamid ali katerokoli sestavino zdravila Vimpat(navedene so v poglavju 6.
Do NOT take Vimpat• if you are allergic(hypersensitive) to lacosamide, or any of the other ingredients of Vimpat(listed in Section 6.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.
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.
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