natgillin/translations-raw huggingface dataset:
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem v RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Subsequent dose adjustments should be performed according to individual response and tolerability as described above.
Kasnejše prilagajanje odmerka se opravi glede na odziv posameznega bolnika in njegovo prenašanje zdravila, kot je opisano zgoraj.
Instead take Lacosamide UCB at the next time that you would normally take it.
Namesto tega zdravilo Lakozamid UCB vzemite ob času naslednjega odmerka, kot bi ga običajno vzeli.
Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
Krvni testi lahko kažejo hudo zmanjšanje v specifični skupini belih krvnih celic (agranulocitoza);
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge (see section 4.8).
Bolnikom (in skrbnikom bolnikov) je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo znaki samomorilnega razmišljanja ali vedenja (glejte poglavje 4.8).
Drug reaction with eosinophilia and systemic symptoms (DRESS) (1,2)
reakcija na zdravilo z eozinofilijo in sistemskimi simptomi (DRESS)(1,2)
(only for the outer carton) Oral use
(samo za zunanjo ovojnino) za peroralno uporabo
Uncommon: may affect up to 1 in 100 children Feeling sleepy or lacking in energy (lethargy).
Občasni: pojavijo se lahko pri največ 1 od 100 otrok • občutek zaspanosti ali pomanjkanja energije (letargija).
Cardiac conduction disorders, shock and coma have also been observed.
Opazili so tudi motnje prevodnosti srca, šok in komo.
Lacosamide UCB is used as a long term treatment.
Zdravilo Lakozamid UCB se uporablja za dolgotrajno zdravljenje.
The bottle containing Lacosamide UCB syrup should be shaken well before use.
Steklenico z zdravilom Lakozamid UCB sirup je treba pred uporabo dobro pretresti.
This major metabolite has no known pharmacological activity.
Glavni presnovek nima znane farmakološke aktivnosti.
The safety and efficacy of lacosamide in paediatric patients with epilepsy syndromes in which focal and generalised seizures may coexist have not been determined.
Varnost in učinkovitost lakozamida pri pediatričnih bolnikih s sindromi epilepsije, pri katerih lahko sočasno pride do fokalnih in generaliziranih napadov, nista bili dokazani.
In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.
Pri bolnikih, pri katerih se razvije resna srčna aritmija, je treba oceniti klinične koristi in tveganja in po potrebi prekiniti zdravljenje z lakozamidom.
• The types of adverse reactions experienced by patients exposed to doses above 400 mg up to 800 mg were not clinically different from those of patients administered recommended doses of lacosamide.
• Vrste neželenih učinkov, ki so se pojavili pri bolnikih, ki so bili izpostavljeni odmerkom nad 400 mg pa do 800 mg se klinično niso razlikovali od tistih, ki so se pojavili pri bolnikih, ki so jemali priporočene odmerke lakozamida.
Lacosamide has minor to moderate influence on the ability to drive and use machines.
Lakozamid ima blag do zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Lacosamide syrup must be taken orally.
Lakozamid sirup se mora jemati peroralno.
Not known: frequency cannot be estimated from available data Changes in behaviour, not acting like themselves.
Neznana pogostnost: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov • spremembe v vedenju, neznačilno vedenje.
Lacosamide UCB may be used on its own or with other antiepileptic medicines.
• Zdravilo Lakozamid UCB se lahko uporablja samostojno ali z drugimi antiepileptiki.
• 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);
• 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);
If you take more than 3 graduation marks of syrup each day and are on a controlled sodium diet, take this into consideration.
Če boste vsak dan vzeli več kot 3 graduacijske oznake sirupa in ste na dieti z nadzorovanim vnosom natrija, bodite na to pozorni.
SPECIAL STORAGE CONDITIONS Do not store above 25°C.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujete pri temperaturi do 25 °C.
The total daily dose and twice daily administration should be maintained.
Pri tem je treba ohraniti enak skupni dnevni odmerek in aplikacijo dvakrat na dan.
A small number of people being treated with antiepileptic medicinal products such as lacosamide have had thoughts of harming or killing themselves.
Pri majhnem številu ljudi, ki so se zdravili z antiepileptiki, kot je lakozamid, so se pojavile misli na samopoškodovanje ali samomor.
Swallow the dose of syrup.
Odmerek sirupa pogoltnite.
For longer term treatment Lacosamide UCB tablets and syrup are available.
Za daljše zdravljenje so na voljo tablete in sirup zdravila Lakozamid UCB.
Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine (see section 4.8).
Bolnikom je zato treba svetovati naj bodo previdni, dokler ne poznajo možnih neželenih učinkov zdravila pri sebi (glejte poglavje 4.8).
Slow heart rate, palpitations, irregular pulse or other changes in the electrical activity of your heart (conduction disorder);
• počasen utrip srca, palpitacije, nepravilen srčni utrip ali druge spremembe v električni aktivnosti srca (motnja prevodnosti);
It should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8).
Odmerek se mora dati pod zdravniškim nadzorom, pri čemer je treba upoštevati možnost povečanja incidence resnih srčnih aritmij in neželenih učinkov na centralni živčni sistem (glejte poglavje 4.8).
Open the bottle by pressing the cap while turning it anti-clockwise (figure 1).
Steklenico odprite, tako da pritiskate na zaporko, medtem ko jo obračate v nasprotni smeri urnega kazalca (slika 1).
Treatment of patients with end-stage renal disease should be made with caution as there is little clinical experience and accumulation of a metabolite (with no known pharmacological activity).
Pri zdravljenju bolnikov s končno ledvično odpovedjo je potrebna previdnost, saj je na voljo malo kliničnih izkušenj, poleg tega se akumulira presnovek (z neznano farmakološko aktivnostjo).
In the elderly population, the maintenance lacosamide dose was 200 mg/day in 55 patients (88.7 %), 400 mg/day in 6 patients (9.7 %) and the dose was escalated to over 400 mg/day in 1 patient (1.6 %).
Pri starejši populaciji je bil vzdrževalni odmerek lakozamida 200 mg/dan pri 55 bolnikih (88,7 %), 400 mg/dan pri 6 bolnikih (9,7 %) in pri 1 bolniku (1,6 %) se je odmerek povečal na več kot 400 mg/dan.
Not recommended
Ni priporočljivo
Behavioural, cognition and emotional functioning were measured by the questionnaires Achenbach CBCL and BRIEF that were applied at baseline and throughout the studies and where mainly stable during the course of the trials.
Vedenjsko, kognitivno in čustveno delovanje so merili z vprašalnikoma Achenbach CBCL in BRIEF, ki so ju uporabili v izhodišču in med študijami.
Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision;
• hitri in nenadzorovani gibi oči (nistagmus), zamegljen vid;
Patients should be counselled to seek immediate medical advice if these symptoms occur.
Bolnikom se mora svetovati, da ob pojavu teh simptomov takoj poiščejo zdravniško pomoč.
Additional side effects when given as an intravenous infusion There may be local side effects.
Dodatni neželeni učinki pri dajanju v obliki intravenske infuzije Lahko se pojavijo lokalni neželeni učinki.
In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes.
Elektrofiziološke študije in vitro so pokazale, da lakozamid selektivno poveča počasno inaktivacijo napetostno odvisnih natrijevih kanalčkov, kar povzroči stabilizacijo hiperekscitabilnih nevronskih membran.
This dose is called a maintenance dose and will depend on how you respond to Lacosamide UCB.
Odmerek se imenuje vzdrževalni odmerek in bo odvisen od vašega odziva na zdravilo Lakozamid UCB.
In vitro data
Podatki in vitro
Lacosamide UCB solution for infusion is available in packages of 1 vial and 5 vials.
Zdravilo Lakozamid UCB raztopina za infundiranje je na voljo v pakiranjih po 1 vialo in po 5 vial.
Aspartame (E951): a source of phenylalanine.
• Aspartam (E951): vir fenilalanina.
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.
Erythema(4)
eritem(4)
Such interactions have not been established in vivo but are possible based on in vitro data.
Čeprav te interakcije in vivo niso bile ugotovljene, so na podlagi podatkov in vitro možne.
When you take Lacosamide UCB with other antiepileptic medicines - Start of the treatment (the first 4 weeks)
Ko boste vzeli zdravilo Lakozamid UCB skupaj z drugimi antiepileptiki - Začetek zdravljenja (prvi 4 tedni)
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.
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. 50 %, kar je deloma povezano z manjšo telesno maso.
Serious allergic reaction which causes swelling of the face, throat, hands, feet, ankles, or lower legs;
• resne alergijske reakcije, ki povzročajo otekanje obraza, žrela, rok, stopal, gležnjev ali spodnjega dela nog;
If you take more Lacosamide UCB than you should If you have taken more Lacosamide UCB than you should, contact your doctor immediately.
Če ste vzeli večji odmerek zdravila Lakozamid UCB, kot bi smeli Če ste vzeli večji odmerek zdravila Lakozamid UCB, kot bi smeli, se takoj posvetujte z zdravnikom.
Administration of a loading dose has not been studied in acute conditions such as status epilepticus.
Dajanja začetnega (polnilnega) odmerka niso preučevali pri akutnih stanjih, kot je status epilepticus.
Exaggerated feeling of wellbeing, seeing and/or hearing things which are not there;
• pretirano dobro počutje, videnje in/ali slišanje stvari, ki niso resnične;
Put the adaptor into the top of the bottle (figure 3).
• nastavek vstavite v zgornji del steklenice (slika 3).
The active substance, lacosamide (R-2-acetamido-N-benzyl-3-methoxypropionamide) is a functionalised amino acid.
Učinkovina lakozamid (R-2-acetamido-N-benzil-3-metoksipropionamid) je delujoča aminokislina.
Packs of 1x20 ml and 5x20 ml.
Pakiranja po 1x20 ml in 5x20 ml.
Wash the oral syringe with water only (figure 13).
• Brizgo za peroralno odmerjanje sperite le z vodo (slika 13).
The patients had to present with unprovoked partial-onset seizures with or without secondary generalisation.
Bolniki so morali imeti neizzvane parcialne napade s sekundarno generalizacijo ali brez nje.
50 mg twice a day (100 mg/day) at weekly intervals
50 mg dvakrat na dan (100 mg/dan) v tedenskih intervalih
Each vial of Lacosamide UCB solution for infusion must be used only once (single use).
Vsaka viala zdravila Lakozamid UCB raztopina za infundiranje se lahko uporabi le enkrat (enkratna uporaba).
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.
Po peroralni in intravenski aplikaciji radioaktivno označenega lakozamida so približno 95 % radioaktivnosti zaznali v seču in manj kot 0,5 % v blatu.
This medicinal product is for single use only, any unused solution should be discarded.
Zdravilo je namenjeno samo enkratni uporabi, neuporabljeno raztopino moramo zavreči.
The 6-month seizure freedom rates in elderly patients of 65 and above (62 patients in lacosamide, 57 patients in carbamazepine CR) were similar between both treatment groups.
Razmerje 6-mesečnega obdobja brez napadov pri starejših bolnikih, starih 65 let in več (62 bolnikov na lakozamidu, 57 bolnikov na karbamazepinu z nadzorovanim sproščanjem) je bilo med obema zdravljenima skupinama podobno.
The body weight normalized difference is 26 and 23 %, respectively.
Normalizirana razlika telesne mase je bila 26 % pri moških in 23 % pri ženskah.
However, a higher incidence (≥ 5 % difference) of fall, diarrhoea and tremor has been reported in elderly patients compared to younger adult patients.
Vendar pa so pri starejših bolnikih poročali o višji incidenci (≥ 5 % razlika) padcev, diareje in tremorja v primerjavi z mlajšimi odraslimi bolniki.
Risk related to lacosamide
Tveganje, povezano z lakozamidom
Fill the measuring cup to the millilitre (ml) dose marker prescribed by your doctor.
Napolnite merico do oznake za odmerek v mililitrih (ml), kot vam ga je predpisal zdravnik.
The usual dose that may be taken per day for each of the first 4 weeks of treatment is shown in the following table.
Običajen odmerek, ki ga boste v vsakem od prvih 4 tednov vzeli na dan, je naveden v spodnji preglednici.
Blood tests may show abnormal liver function, liver injury;
• krvne preiskave lahko pokažejo nenormalne vrednosti jetrne funkcije, poškodba jeter;
The paediatric pharmacokinetic profile of lacosamide was determined in a population pharmacokinetic analysis using sparse plasma concentration data obtained in one placebo-controlled randomised study and three open-label studies in 414 children with epilepsy aged 6 months to 17 years.
Pediatrični farmakokinetični profil lakozamida je bil ugotovljen v populacijski farmakokinetični analizi z uporabo redkih podatkov o koncentraciji v plazmi, pridobljenih v eni s placebom nadzorovani randomizirani študiji in treh odprtih študijah pri 414 otrocih z epilepsijo, starih od 6 mesecev do 17 let.
You would then start your ongoing maintenance dose 12 hours later.
Svoj redni vzdrževalni odmerek boste začeli nato jemati 12 ur pozneje.
Lacosamide should be administered to adult and paediatric patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks.
Odraslim in pediatričnim bolnikom s hudo okvaro jeter lahko dajemo lakozamid samo takrat, ko se predvideva, da bo pričakovana terapevtska korist odtehtala možna tveganja.
The plasma concentration increases proportionally with dose after oral (100-800 mg) and intravenous (50-300 mg) administration.
Plazemska koncentracija narašča sorazmerno z odmerkom pri peroralni (100 - 800 mg) in intravenski (50 - 300 mg) uporabi.
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-desmetilni presnovek (manj kot 30 %).
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 exposure.
V študijah toksičnosti so bile plazemske koncentracije lakozamida podobne ali le mejno povečane v primerjavi s koncentracijami, ki so jih opazili pri bolnikih, kar dovoljuje majhne ali neobstoječe mejne vrednosti izpostavljenosti pri človeku.
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).
you have severe heart disease such as heart failure or have had a heart attack.
• imate hudo srčno obolenje, kot sta srčno popuščanje ali če ste imeli srčni infarkt;
The efficacy supported by the extrapolation principle stated above was confirmed by a double-blind, randomised, placebo-controlled study.
Učinkovitost, podprto z zgoraj navedenim načelom ekstrapolacije, je potrdila dvojno slepa, randomizirana, s placebom nadzorovana študija.
Hepatic enzyme increased (> 2x ULN) (1)
povišane vrednosti jetrnih encimov (> 2x ULN) (1)
The quality of life assessed by the Pediatric Quality of Life Inventory indicated that subjects in both lacosamide and placebo groups had a similar and stable health-related quality of life during the entire treatment period.
Kakovost življenja, ocenjena s pediatričnim vprašalnikom o kakovosti življenja (Pediatric Quality of Life Inventory), je pokazala, da so imele osebe v skupini z lakozamidom in v skupini s placebom celotno obdobje zdravljenja podobno in stabilno kakovost življenja v zvezi z zdravjem.
Studies in animals did not indicate any teratogenic effects in rats or rabbits, but embryotoxicity was observed in rats and rabbits at maternal toxic doses (see section 5.3).
Študije na živalih, pri podganah ali kuncih, niso pokazale teratogenih učinkov, vendar so pri podganah in kuncih opazili embriotoksičnost pri odmerkih, ki so bili toksični tudi za mater (glejte poglavje 5.3).
Partial-onset seizures have a similar clinical expression in children from 4 years of age and in adults.
Parcialni napadi imajo pri otrocih od 4. leta starosti in pri odraslih podoben klinični izraz.
The overall duration of treatment with intravenous lacosamide is at the physician's discretion; there is experience from clinical trials with twice daily infusions of lacosamide for up to 5 days in adjunctive therapy.
Skupno trajanje zdravljenja z intravenskim lakozamidom je po presoji zdravnika; izkušnje iz kliničnih preskušanj z dvakrat dnevnim infundiranjem lakozamida so za uporabo zdravila do 5 dni.
They were usually mild to moderate in intensity.
Učinki so bili po intenziteti običajno blagi do zmerni.
The table below shows the frequencies of adverse reactions which have been reported in clinical trials and post-marketing experience.
V spodnji preglednici je prikazana pogostnost neželenih učinkov, o katerih so poročali v kliničnih preskušanjih in v izkušnjah dobljenih v obdobju trženja.
In treated patients who completed titration and started withdrawing antiepileptic medicinal products (284 and 99 respectively), monotherapy was maintained in 71.5 % and 70.7 % of patients respectively for 57-105 days (median 71 days), over the targeted observation period of 70 days.
Pri zdravljenih bolnikih, ki so končali titracijo in začeli s prenehanjem jemanja antiepileptikov (284 oziroma 99), je bilo v ciljnem opazovanem obdobju 70 dni samostojno zdravljenje vzdrževano pri 71,5 % oziroma 70,7 % bolnikov od 57-105 dni (mediana 71 dni).
• Reactions reported after an intake of more than 800 mg are dizziness, nausea, vomiting, seizures (generalised tonic-clonic seizures, status epilepticus).
• Neželeni učinki, o katerih so poročali po vnosu več kot 800 mg so omotica, navzea, bruhanje, epileptični napadi (generalizirani tonično-klonični napadi, status epilepticus).
Lacosamide must be taken twice a day (usually once in the morning and once in the evening).
Lakozamid mora bolnik vzeti dvakrat na dan (običajno enkrat zjutraj in enkrat zvečer).
The pharmacokinetics and safety of a single loading dose of intravenous lacosamide were determined in a multicenter, open-label study designed to assess the safety and tolerability of rapid initiation of lacosamide using a single intravenous loading dose (including 200 mg) followed by twice daily oral dosing (equivalent to the intravenous dose) as adjunctive therapy in adult subjects 16 to 60 years of age with partial-onset seizures.
Farmakokinetika in varnost enkratnega začetnega (polnilnega) odmerka lakozamida za intravensko uporabo sta bili določeni z multicentrično, odprto študijo, s katero so ocenili varnost in prenašanje hitrega vnosa lakozamida z uporabo enkratnega intravenskega začetnega (polnilnega) odmerka (vključuje 200 mg), ki mu sledi peroralno odmerjanje dvakrat na dan (ekvivalentno intravenskemu odmerku) kot dopolnilno zdravljenje pri odraslih osebah, starih od 16 do 60 let, s parcialnimi napadi.
Efficacy of lacosamide as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine CR in 886 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Učinkovitost lakozamida pri samostojnem zdravljenju je bila ugotovljena v dvojno slepi, z vzporednimi skupinami, ne-inferiorni primerjavi s karbamazepinom z nadzorovanim sproščanjem pri 886 bolnikih, starih 16 let ali starejših, z na novo ali nedavno diagnosticirano epilepsijo.
Use the measuring cup provided in this pack.
• Uporabite merico, ki je priložena temu pakiranju.
If you take more than 12.5 ml of syrup each day and are on a controlled sodium diet, take this into consideration.
Če boste vsak dan vzeli več kot 12,5 ml sirupa in ste na dieti z nadzorovanim vnosom natrija, bodite na to pozorni.
Lacosamide is primarily eliminated from the systemic circulation by renal excretion and biotransformation.
Lakozamid se iz sistemskega krvnega obtoka primarno izloča z ledvično ekskrecijo in biotransformacijo.
A loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted.
Začetni (polnilni) odmerek lahko dajemo bolnikom v primerih, ko zdravnik ugotovi, da sta zagotovljena hiter doseg stanja dinamičnega ravnovesja koncentracije lakozamida v plazmi in terapevtski učinek.
A total of 67.8 % of patients randomised to lacosamide and 58.1 % of patients randomised to placebo reported at least 1 adverse reaction.
Skupaj 67,8 % bolnikov, randomiziranih na lakozamid, in 58,1 % bolnikov, randomiziranih na placebo, je poročalo o vsaj enem neželenem učinku.
In accordance with current clinical practice, if lacosamide has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week).
V skladu s trenutno klinično prakso je priporočljivo, da je prekinitev zdravljenja z lakozamidom postopna (npr. zmanjševanje dnevnega odmerka za 200 mg/teden).
Cardiac rhythm and conduction
Srčni ritem in prevodnost
For most patients the maintenance dose is between 200 mg and 400 mg per day.
Pri večini bolnikov je vzdrževalni odmerek med 200 mg in 400 mg na dan.
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).
This will be until you reach a maintenance dose.
Odmerek bo povečeval, dokler ne boste dosegli vzdrževalnega odmerka.
Lacosamide may be taken with or without food.
Lakozamid se lahko jemlje s hrano ali brez nje.
Risk related to epilepsy and antiepileptic medicinal products in general For all antiepileptic medicinal products, it has been shown that in the offspring of treated women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population.
Tveganje, povezano z epilepsijo, in antiepileptiki na splošno Pri vseh antiepileptikih se je pokazalo, da je pri potomcih zdravljenih žensk z epilepsijo, prevalenca malformacij dva- do trikrat večja kot pri normalni populaciji, kjer je ta približno 3 %.