natgillin/translations-raw huggingface dataset:
Alternativt kan produktet sættes i køleskab (2 °C- 8 °C) straks efter rekonstitutionen og opbevares i køleskabet i højst 8 timer, hvis det skal rekonstitueres forud for administrationen.
Alternatively, if the product needs to be reconstituted in advance of the administration, it must be placed in a refrigerator (2°C to 8°C) immediately after reconstitution, and kept in the refrigerator for a maximum of 8 hours.
20 °C - 25 °C.
The syringe filled with reconstituted suspension should be allowed up to 30 minutes prior to administration to reach a temperature of approximately 20ºC-25ºC.
Samlet dosis (mg) = Dosis (mg/ m2) x BSA( m2)
Total dose (mg) = Dose (mg/ m2) x BSA (m2)
Nye injektioner bør indgives mindst 2, 5 cm fra det forrige sted og aldrig i områder, hvor stedet er ømt, blodunderløbent, rødt eller hårdt.
New injections should be given at least 2.5 cm from the previous site and never into areas where the site is tender, bruised, red, or hardened.
Det fås som ovale tabletter (lyserød:
It is available as oval tablets (pink:
50 mg; gul:
50 mg; yellow:
100 mg; laksefarvet:
100 mg; salmon:
150 mg; blå:
150 mg; blue:
200 mg), som en syrup (15 mg/ ml) og som en opløsning til infusionsvæske (drop i en vene, 10 mg/ ml).
200 mg), as a syrup (15 mg/ ml) and as a solution for infusion (drip into a vein, 10 mg/ ml).
Vimpat kan anvendes til patienter med partielle anfald med eller uden sekundær generalisering (hvor anfaldet efterfølgende spreder sig til hele hjernen).
It can be used in patients with partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to the whole brain).
Vimpat tages to gange dagligt i forbindelse med et måltid eller mellem måltider.
Vimpat is taken twice a day, with or without food.
Efter en uge bør dosis øges til 100 mg to gange dagligt, og derefter kan det afhængigt af patientens respons være nødvendigt at øge yderligere hver uge med 50 mg to gange dagligt op til en maksimal dosis på 200 mg to gange dagligt.
After one week, the dose should be increased to 100 mg twice a day and then, depending on the patient’ s response, it may be further increased every week by 50 mg twice a day to the maximum dose of 200 mg twice a day.
En særlig pakning med tabletter i alle fire styrker fås som hjælp til behandlingsopstart.
A special pack with tablets of all four strengths is available to help when initiating treatment.
Lavere doser kan anvendes til patienter, der har nyreproblemer.
Lower doses may be used in patients who have problems with their kidneys.
Hvis patienten er midlertidigt ude af stand til at tage tabletterne eller syrupen, kan Vimpat i samme dosis gives som en infusion over 15 minutter til 1 time.
If the patient is temporarily unable to take the tablets or syrup, Vimpat can be given at the same dose as an infusion lasting 15 minutes to one hour.
Denne indgivelsesvej bør kun anvendes i få dage.
This should only be used for a few days.
Lacosamid menes også at medvirke ved udviklingen af nerveceller, der er blevet beskadiget.
Lacosamide is also thought to be involved in the development of nerve cells that have been damaged.
Tilsammen kan disse virkemåder forhindre, at anormal elektrisk aktivitet spredes gennem hjernen, og derigennem mindske risikoen for epileptiske anfald.
The effects of Vimpat were first tested in experimental models before being studied in humans.
Virkningen af Vimpat taget gennem munden blev sammenlignet med virkningen af placebo (inaktiv behandling) i tre hovedundersøgelser med i alt 1 308 patienter.
The effectiveness of Vimpat taken by mouth has been compared with that of placebo (a dummy treatment) in three main studies involving a total of 1,308 patients.
Den primære parameter til måling af virkningen var antallet af patienter, der mindst opnåede en halvering af antallet af epileptiske anfald efter 12 ugers behandling med en stabil dosis.
The main measure of effectiveness was the number of patients whose number of seizures was at least halved after 12 weeks of treatment with a stable dose.
I yderligere to undersøgelser, hvor i alt 199 patienter deltog, så man nærmere på, hvilken varighed infusionen af Vimpat- opløsningen optimalt skulle have, og sammenlignede sikkerheden ved lægemidlet med sikkerheden ved placebo- infusion.
Two additional studies looked at the appropriate duration of the infusion for Vimpat solution and compared its safety with that of placebo infusions in a total of 199 patients.
Hvis man ser på resultaterne af de tre hovedundersøgelser tilsammen, opnåede 34% af de patienter, der fik 200 mg Vimpat dagligt, og 40% af de patienter, der fik 400 mg Vimpat dagligt i tillæg til den eksisterende behandling, en reduktion på mindst 50% af antallet af anfald.
Looking at the results of the three main studies taken together, 34% of the patients adding Vimpat 200 mg/ day and 40% of the patients adding Vimpat 400 mg/ day to their existing treatment achieved at least a 50% reduction in the number of seizures.
Blandt de patienter, der fik placebo i tillæg til den eksisterende behandling, opnåede 23% det samme resultat.
This was compared with 23% of the patients adding placebo.
Dosen på 600 mg var lige så effektiv som 400 mg- dosen, men havde flere bivirkninger.
The 600-mg dose was as effective as the 400-mg dose, but it had more side effects.
Den fuldstændige liste over alle de indberettede bivirkninger ved Vimpat fremgår af indlægssedlen.
For the full list of all side effects reported with Vimpat, see the Package Leaflet.
Vimpat bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for lacosamid eller andre af indholdsstofferne, eller som har en AV- blok af 2. eller 3. grad (en form for forstyrrelse af hjerterytmen).
Vimpat should not be used in people who may be hypersensitive (allergic) to lacosamide or any of the other ingredients, or who have second or third degree AV block (a type of heart rhythm disorder).
Vimpat- tabletter må ikke anvendes til patienter, der er overfølsomme over for peanuts eller soja.
Vimpat tablets must not be used in people who are hypersensitive to peanut or soya.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Vimpat er større end risiciene, når det anvendes som tillæg til behandlingen af partielle epileptiske anfald med eller uden sekundær generalisering hos epilepsipatienter i alderen 16 år og opefter.
The Committee for Medicinal Products for Human Use (CHMP) decided that Vimpat’ s benefits are greater than its risks when used as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Vimpat.
The Committee recommended that Vimpat be given marketing authorisation.
Andre oplysninger om Vimpat:
Other information about Vimpat:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vimpat til UCB Pharma S. A. den 29. august 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Vimpat to UCB Pharma S. A. on 29 August 2008.
Den fuldstændige EPAR for Vimpat findes her.
The full EPAR for Vimpat can be found here.
Indhold
Route of
50 mg 50 mg 50 mg 100 mg 100 mg 100 mg 150 mg 150 mg 150 mg 200 mg 200 mg 200 mg 50/ 100/ 150/ 200 mg
50 mg 50 mg 50 mg 100 mg 100 mg 100 mg 150 mg 150 mg 150 mg 200 mg 200 mg 200 mg 50/ 100/ 150/ 200 mg
Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu)
Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu) Blister (PVC/ PVDC/ alu)
14 tabletter 56 tabletter 168 tabletter 14 tabletter 56 tabletter 168 tabletter 14 tabletter 56 tabletter 168 tabletter 14 tabletter 56 tabletter 168 tabletter Behandlingsstartpakke:
14 tablets 56 tablets 168 tablets 14 tablets 56 tablets 168 tablets 14 tablets 56 tablets 168 tablets 14 tablets 56 tablets 168 tablets Treatment initiation pack:
14 tabletter + 14 tabletter + 14 tabletter + 14 tabletter
14 tablets + 14 tablets + 14 tablets + 14 tablets
EU/ 1/ 08/ 470/ 014 EU/ 1/ 08/ 470/ 015 EU/ 1/ 08/ 470/ 016
EU/ 1/ 08/ 470/ 014 EU/ 1/ 08/ 470/ 015 EU/ 1/ 08/ 470/ 016
Vimpat Vimpat Vimpat
Vimpat Vimpat Vimpat
15 mg/ ml 15 mg/ ml 10 mg/ ml
15 mg/ ml 15 mg/ ml 10 mg/ ml
Syrup Syrup Infusionsvæske, opløsning
Syrup Syrup Solution for infusion
Oral anvendelse Oral anvendelse Intravenøs anvendelse
Oral use Oral use Intravenous use
Flaske (glas eller PET) Flaske (glas eller PET) Hætteglas (glas)
Bottle (glass or PET) Bottle (glass or PET) Vial (glass)
200 ml 465 ml 20 ml
200 ml 465 ml 20 ml
1 flaske 1 flaske 1 hætteglas
1 bottle 1 bottle 1 vial
PRODUKTRESUMÉ 1.
1 1.
Hver filmovertrukket tablet indeholder 0, 17 mg soyalecithin.
Each film-coated tablet contains 0.17 mg soya-lecithin.
Filmovertrukket tablet Lyserødlig, oval filmovertrukket tablet præget med ‘ SP ’ på den ene side og ‘ 50 ’ på den anden.
Film-coated tablet Pinkish, oval film-coated tablet debossed with ‘ SP’ on one side and ‘ 50’ on the other side.
Vimpat er indiceret som tillægsbehandling af fokale anfald med eller uden sekundær generalisering hos patienter i alderen 16 år og ældre med epilepsi.
Vimpat is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
Vimpat skal tages to gange daglig.
Vimpat must be taken twice a day.
Vimpat kan indtages alene eller sammen med mad.
Vimpat may be taken with or without food.
200 mg/ uge).
In accordance with current clinical practice, if Vimpat has to be discontinued, it is recommended this be done gradually (e. g. taper the daily dose by 200 mg/ week).
Patienter med nedsat nyrefunktion Dosisjustering er ikke nødvendig hos patienter med mildt til moderat nedsat nyrefunktion (CLCR > 30 ml/ min).
Use in patients with renal impairment No dose adjustment is necessary in mildly and moderately renally impaired patients (CLCR > 30 ml/ min).
En maksimal dosis på 250 mg/ dag anbefales til patienter med alvorligt nedsat nyrefunktion (CLCR ≤30 ml/ min) og til patienter med nyresygdom i slutstadiet.
A maximum dose of 250 mg/ day is recommended for patients with severe renal impairment (CLCR ≤ 30 ml/ min) and in patients with endstage renal disease.
Til hæmodialyse - krævende patienter anbefales det at supplere med op til 50% af den opdelte daglige dosis direkte efter endt hæmodialyse.
For patients requiring haemodialysis a supplement of up to 50% of the divided daily dose directly after the end of haemodialysis is recommended.
5. 2).
In all patients with renal impairment, the dose titration should be performed with caution (see section 5.2).
Patienter med nedsat leverfunktion Dosisjustering er ikke nødvendig hos patienter med mildt til moderat nedsat leverfunktion.
Use in patients with hepatic impairment No dose adjustment is needed for patients with mild to moderate hepatic impairment.
5. 2).
The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients (see section 5.2).
2 Ældre (over 65 år) Dosisjustering er ikke nødvendig hos ældre patienter.
Use in elderly (over 65 years of age) No dose reduction is necessary in elderly patients.
5. 2).
2 should be considered in elderly patients (see ‘ Use in patients with renal impairment’ above and section 5.2).
Pædiatriske patienter Vimpat bør ikke anvendes til børn og unge under 16 år, da der ikke foreligger data om sikkerhed og virkning hos denne aldersgruppe.
Paediatric patients Vimpat is not recommended for use in children and adolescents below the age of 16 as there is no data on safety and efficacy in these age groups.
Overfølsomhed over for det aktive stof eller over for peanuts eller soja eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substance or to peanuts or soya or to any of the excipients.
4. 8).
Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine (see section 4.8).
Der er observeret forlængelser af PR- intervallet med lacosamid i kliniske studier.
Prolongations in PR interval with lacosamide have been observed in clinical studies.
Lacosamid skal anvendes med forsigtighed til patienter med overledningsforstyrrelser eller alvorlig hjertesygdom som f. eks. myokardieinfarkt eller hjertesvigt i anamnesen.
Lacosamide should be used with caution in patients with known conduction problems or severe cardiac disease such as a history of myocardial infarction or heart failure.
Der bør især udvises forsigtighed ved behandling af ældre patienter, da ældre kan have en forøget risiko for hjertesygdomme, eller når lacosamid anvendes samtidig med produkter, som man ved er forbundet med PR- forlængelse.
Caution should especially be exerted when treating elderly patients as they may be at an increased risk of cardiac disorders or when lacosamide is used in combination with products known to be associated with PR prolongation.
Selvmordstanker og – adfærd er rapporteret hos patienter i behandling med antiepileptika.
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications.
En metaanalyse af randomiserede, placebokontrollerede forsøg med antiepileptika har vist en let forøget risiko for selvmordstanker og – adfærd.
A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Derfor bør patienterne overvåges for, om de får tegn på selvmordstanker og – adfærd, og passende behandling bør overvejes.
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Patienter (og plejepersonale) bør tilrådes straks at søge læge, hvis der opstår tegn på selvmordstanker og – adfærd.
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Lacosamid bør anvendes med forsigtighed hos patienter i behandling med lægemidler, som man ved er forbundet med PR- forlængelse (f. eks. carbamazepin, lamotrigin, pregabalin) samt hos patienter i behandling med klasse I- antiarytmetika.
Lacosamide should be used with caution in patients treated with medicinal products known to be associated with PR prolongation (e. g. carbamazepine, lamotrigine, pregabalin) and in patients treated with class I antiarrhythmic drugs.
Undergruppeanalyser i kliniske studier viste dog ikke forøget PR- forlængelse hos patienter ved samtidig administration af carbamazepin eller lamotrigin.
However, subgroup analysis did not identify an increased magnitude of PR prolongation in patients with concomitant administration of carbamazepine or lamotrigine in clinical trials.
In vitro- studier viser, at enzymerne CYP1A2, 2B6 og 2C9 ikke induceres, og at CYP1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2D6 og 2E1 ikke hæmmes af lacosamid ved plasmakoncentrationer observeret i kliniske forsøg.
In vitro studies indicate that the enzymes CYP1A2, 2B6, and 2C9 are not induced and that CYP1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2D6, and 2E1 are not inhibited by lacosamide at plasma concentrations observed in clinical trials.
Et in vitro - studie har vist, at lacosamid ikke transporteres af P- glycoprotein i tarmen.
An in vitro study indicated that lacosamide is not transported by P-glycoprotein in the intestine.
Lacosamid hæmmer eller inducerer ikke enzymet CYP2C19 in vivo.
Lacosamide does not inhibit or induce the enzyme CYP2C19 in vivo.
In vitro- studier tyder på, at lacosamid kan være en svag hæmmer og inducer af CYP3A4.
In vitro studies indicate that lacosamide may be a weak inhibitor and inducer of CYP3A4.
Den kliniske relevans af dette er på nuværende tidspunkt ikke kendt.
The clinical relevance of this is presently unknown.
Et interaktionsstudie med carbamazepin tyder ikke på en markant hæmmende effekt af lacosamid på CYP3A4 katalyseret metabolisme i terapeutiske doser.
An interaction study with carbamazepine does not indicate a marked inhibitory effect of lacosamide on CYP3A4 catalysed metabolism at therapeutic doses.
Stærke enzym- inducere såsom rifampicin eller prikbladet perikon (Hypericum perforatum) kan reducere lacosamids systemiske indvirkning i moderat grad.
Strong enzyme inducers such as rifampicin or St John´s wort (Hypericum perforatum) may moderately reduce the systemic exposure of lacosamide.
Derfor bør opstart eller afslutning af behandlingen med disse enzym- inducere udføres med forsigtighed.
Therefore, starting or ending treatment with these enzyme inducers should be done with caution.
3 Antiepileptika I interaktionsforsøg påvirkede lacosamid ikke signifikant plasmakoncentrationen af carbamazepin og valproinsyre.
Antiepileptic drugs In interaction trials lacosamide did not significantly affect the plasma concentrations of carbamazepine
En PK- analyse i befolkningen vurderede, at samtidig behandling med andre enzym - inducerende antiepileptiske lægemidler (carbamazepin, phenytoin, phenobarbital i forskellige doser) nedsatte lacosamids samlede systemiske indvirkning med 25%.
A population PK analysis estimated that concomitant treatment with other anti-epileptic drugs known to be enzyme inducers (carbamazepine, phenytoin, phenobarbital, in various doses) decreased the overall systemic exposure of lacosamide by 25%.
P- piller I et interaktionsforsøg sås ingen klinisk relevant interaktion mellem lacosamid og p- pillerne ethinyløstradiol og levonorgestrel.
Oral contraceptives In an interaction trial there was no clinically relevant interaction between lacosamide and the oral contraceptives ethinylestradiol and levonorgestrel.
Andre Interaktionsforsøg viste, at lacosamid ikke havde nogen effekt på digoxins farmakokinetik.
Others Interaction trials showed that lacosamide had no effect on the pharmacokinetics of digoxin.
Omeprazol 40 mg daglig forøgede lacosamids AUC med 19%.
Omeprazole 40 mg q. d. increased the AUC of lacosamide by 19%.
Denne effekt mangler muligvis klinisk relevans.
The effect probably lacks clinical relevance.
Lacosamid påvirkede ikke enkeltdosisfarmakokinetikken af omeprazol.
Lacosamide did not affect the single-dose pharmacokinetics of omeprazole.
Der er ingen data tilgængelige om interaktion mellem lacosamid og alkohol.
No data on the interaction of lacosamide with alcohol are available.
Lacosamid har en lav proteinbinding på under 15%.
Lacosamide has a low protein binding of less than 15%.
Graviditet Risiko relateret til epilepsi og antiepileptika generelt Det gælder for alle antiepileptika, at forekomsten af misdannelser hos børn af kvinder, der er behandlet for epilepsi, er 2- 3 gange højere end for den generelle befolkning, hvor forekomsten er ca.
Pregnancy Risk related to epilepsy and antiepileptic medicinal products in general For all anti-epileptic drugs, it has been shown that in the offspring of women treated with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3% in the general population.
Hos den behandlede befolkning er en stigning i misdannelser set ved polyterapi, men i hvilket omfang behandlingen og/ eller sygdommen er ansvarlig er ikke blevet belyst.
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.
Risiko relateret til lacosamid Der findes ingen adækvate data vedrørende anvendelse af lacosamid til gravide kvinder.
Risk related to lacosamide There are no adequate data from the use of lacosamide in pregnant women.
Dyrestudier har ikke påvist teratogene virkninger hos rotter eller kaniner, men ved dosisniveauer, der er toksiske for hunnen, er der observeret embryotoksicitet hos rotter og kaniner (se pkt.
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).
Amning Det vides ikke, om lacosamid udskilles i human modermælk.
Lactation It is unknown whether lacosamide is excreted in human breast milk.
Vimpat kan påvirke evnen til at føre motorkøretøj og betjene maskiner i mindre eller moderat grad.
Vimpat may have minor to moderate influence on the ability to drive and use machines.
Behandling med Vimpat er blevet forbundet med svimmelhed eller sløret syn.
Vimpat treatment has been associated with dizziness or blurred vision.
Patienterne bør derfor rådes til først at køre bil eller betjene andre potentielt farlige maskiner, når de er fortrolige med, hvilken effekt Vimpat har på deres evne til at udføre sådanne aktiviteter.
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.
Baseret på analysen af poolede placebo- kontrollerede kliniske forsøg, omfattende 1. 308 patienter med
The most frequently reported adverse reactions with
De mest almindeligt rapporterede bivirkninger ved lacosamidbehandling var svimmelhed, hovedpine, kvalme og diplopi (dobbeltsyn).
4 lacosamide treatment were dizziness, headache, nausea and diplopia.
Incidensen og alvorligheden af bivirkninger på centralnervesystemet og mave- tarmkanalen aftog i reglen med tiden.
Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time.
For alle kontrollerede studier var seponeringsraten på grund af bivirkninger 12, 2% for patienter randomiseret til lacosamid, og 1, 6% for patienter randomiseret til 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.
Nedenstående tabel viser hyppigheden af bivirkninger, der er rapporteret i poolede placebo - kontrollerede kliniske forsøg.
The table below shows the frequencies of adverse reactions which have been reported in pooled placebo-controlled clinical trials.
Hyppigheden er defineret som følger: meget almindelig (≥1/ 10), almindelig (≥1/ 100 til < 1/ 10), ikke almindelig (≥1/ 1. 000 til < 1/ 100).
The frequencies are defined as follows: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10), uncommon (≥ 1/ 1,000 to < 1/ 100).
Inden for hver enkelt frekvensgruppe opstilles bivirkningerne efter, hvor alvorlige de er.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System - organklasse
System organ class
Balanceforstyrrelse Abnorm koordination Svækket hukommelse Kognitiv forstyrrelse Somnolens Tremor Nystagmus
Balance disorder Coordination abnormal Memory impairment Cognitive disorder Somnolence Tremor Nystagmus
Sløret syn Vertigo
Vision blurred Vertigo
Opkastning Forstoppelse Flatulens
Vomiting Constipation Flatulence
Almene symptomer og reaktioner på administrationsstedet
General disorders and administration site conditions Injury, poisoning and procedural complications
Traumer, forgiftninger og behandlings - komplikationer
Gait disturbance Asthenia Fatigue Fall Skin laceration
Brug af lacosamid er forbundet med en dosisrelateret forlængelse af PR- intervallet.
The use of lacosamide is associated with dose-related increase in the PR interval.