FrancophonIA/ELRC3.0 huggingface dataset:
English: Whereas, in controlled clinical trials with bipolar disorder patients, skin rashes occurred in 8% of patients taking lamotrigine and in 6% of patients taking placebo.
Slovenian: V kontroliranih kliničnih preskušanjih pri bolnikih z bipolarno motnjo pa so se izpuščaji na koži pojavili pri 8 % bolnikov, ki so jemali lamotrigin in pri 6 % bolnikov, ki so jemali placebo.
English: This leaflet was last approved in {MM/YYYY}.
Slovenian: Navodilo je bilo odobreno {MM. LLLL}.
English: Pharmacotherapeutic group: other antiepileptics, ATC code: N03AX09.
Slovenian: Oznaka ATC: N03AX09.
English: diplopia, blurred vision.
Slovenian: diplopija, zamegljen vid.
English: Adults aged 18 years and above - Prevention of depressive episodes in patients with bipolar I disorder who experience predominantly depressive episodes (see section 5.1).
Slovenian: Bipolarna motnja Odrasli od 18. leta naprej - Preprečevanje depresivnih epizod pri bolnikih z bipolarno motnjo I, ki imajo predvsem depresivne epizode (glejte poglavje 5.1).
English: • clumsiness and lack of co-ordination, affecting their balance (ataxia)
Slovenian: • okornost in pomanjkljiva usklajenost gibov, ki prizadene ravnotežje (ataksija),
English: Although the majority recover on withdrawal of lamotrigine treatment, some patients experience irreversible scarring and there have been rare cases of associated death (see section 4.4).
Slovenian: Večina bolnikov po prenehanju uporabe lamotrigina sicer okreva, a pri nekaterih ostanejo trajne brazgotine, bilo pa je tudi nekaj redkih smrtnih primerov (glejte poglavje 4.4).
English: If you develop any of these symptoms after you start taking Lamictal, get a doctor's help straight away:
Slovenian: Če se vam po začetku jemanja zdravila Lamictal pojavi katerikoli od naslednjih simptomov, nemudoma poiščite zdravniško pomoč:
English: Precautions relating to bipolar disorder
Slovenian: Previdnostni ukrepi pri bipolarni motnji
English: In addition, dose-related undesirable effects should be monitored after birth.
Slovenian: Poleg tega je treba bolnice po porodu kontrolirati glede neželenih učinkov, odvisnih od odmerka.
English: Intake of folic acid when planning pregnancy and during early pregnancy may be considered.
Slovenian: Priporočeno je uživanje folne kisline med načrtovanjem nosečnosti in v zgodnji nosečnosti.
English: Serious potentially life-threatening skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's Syndrome) have been reported.
Slovenian: Opisani so bili resni, potencialno smrtno nevarni izpuščaji, vključno s Stevens-Johnsonovim sindromom in toksično epidermalno nekrolizo (Lyellov sindrom).
English: There are no data for monotherapy in seizures associated with Lennox-Gastaut syndrome.
Slovenian: Na voljo ni podatkov o monoterapiji pri napadih, povezanih z Lennox-Gastautovim sindromom.
English: In supportive analyses of time to first depressive episode and time to first manic/hypomanic or mixed episode, the lamotrigine-treated patients had significantly longer times to first depressive episode than placebo patients, and the treatment difference with respect to time to manic/hypomanic or mixed episodes was not statistically significant.
Slovenian: V podpornih analizah časa do prve depresivne epizode in časa do prve manične/hipomanične ali mešane epizode so bili pri bolnikih zdravljenih z lamotrigino časi pomembno daljši do prve depresivne epizode kot med uporabo placeba.
English: However, in a prospective study in healthy adult volunteers using doses of 200 mg lamotrigine and 1200 mg oxcarbazepine, oxcarbazepine did not alter the metabolism of lamotrigine and lamotrigine did not alter the metabolism of oxcarbazepine.
Slovenian: Toda v prospektivni študiji zdravih odraslih prostovoljcev, ki so jemali 200 mg lamotrigina in 1200 mg okskarbazepina, okskarbazepin ni spremenil presnove lamotrigina, lamotrigin pa ni spremenil presnove okskarbazepina.
English: In adults enrolled in studies utilizing the current lamotrigine dosing recommendations the incidence of serious skin rashes is approximately 1 in 500 in epilepsy patients.
Slovenian: V študijah, v katerih so lamotrigin uporabljali po trenutno veljavnih priporočilih za odmerjanje, je bila incidenca resnih izpuščajev na koži pri odraslih bolnikih z epilepsijo približno 1 na 500 primerov.
English: Additionally the overall risk of rash appears to be strongly associated with:
Slovenian: Poleg tega je tveganje za izpuščaj močno povezano z:
English: In another study, single oral doses of 600 mg carbamazepine significantly impaired fine visual motor co-ordination and eye movements, while increasing both body sway and heart rate, whereas results with lamotrigine at doses of 150 mg and 300 mg did not differ from placebo.
Slovenian: V drugi študiji so posamični peroralni odmerki 600 mg karbamazepina pomembno poslabšali fino vizualnomotorično koordinacijo in gibe oči ter povečali nihanje telesa in srčno frekvenco, učinki lamotrigina v odmerkih 150 mg in 300 mg pa se niso razlikovali od tistih pri placebu.
English: • For adults and children aged 13 years and over, Lamictal can be used on its own or with other medicines, to treat epilepsy.
Slovenian: • Odrasli in otroci od 13. leta naprej lahko jemljejo Lamictal sam ali skupaj z drugimi zdravili, in sicer za zdravljenje epilepsije.
English: Topiramate resulted in no change in plasma concentrations of lamotrigine.
Slovenian: Topiramat ni spremenil plazemske koncentracije lamotrigina.
English: Although changes in the plasma concentrations of other AEDs have been reported, controlled studies have shown no evidence that lamotrigine affects the plasma concentrations of concomitant AEDs.
Slovenian: Čeprav so poročali o spremembah v plazemskih koncentracijah drugih antiepileptikov, kontrolirane klinične študije niso pokazale vpliva lamotrigina na plazemsko koncentracijo sočasno uporabljenih antiepileptikov.
English: In double-blind, adjunctive clinical trials in adults, skin rashes occurred in up to 10% of patients taking lamotrigine and in 5% of patients taking placebo.
Slovenian: V dvojno slepih kliničnih preskušanjih pri odraslih je imelo izpuščaje do 10 % bolnikov, ki so jemali lamotrigin, in 5 % bolnikov, ki so jemali placebo.
English: Clinical efficacy in the prevention of mood episodes in patients with bipolar disorder
Slovenian: Klinična učinkovitost pri preprečevanju razpoloženjskih epizod pri bolnikih z bipolarno motnjo:
English: Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms (see Immune system disorders**).
Slovenian: O izpuščaju so poročali tudi kot o delu preobčutljivostnega sindroma, ki ga spremljajo različne kombinacije sistemskih simptomov (glejte Bolezni imunskega sistema**).
English: In contrast, the mechanisms by which lamotrigine exerts its therapeutic action in bipolar disorder have not been established, although interaction with voltage gated sodium channels is likely to be important.
Slovenian: V nasprotju s tem mehanizem terapevtskega delovanja lamotrigina, mehanizem pri bipolarni motnji ni ugotovljen, čeprav je verjetno pomembno njegovo delovanje na napetostno aktivirane natrijeve kanale.
English: It is recommended that Lamictal not be restarted in patients who have discontinued due to rash associated with prior treatment with lamotrigine unless the potential benefit clearly outweighs the risk.
Slovenian: Bolnikom, ki so prenehali prejemati zdravilo Lamictal zaradi izpuščaja, ki je bil posledica predhodnega zdravljenjem z lamotriginom, tega zdravila ni priporočljivo ponovno uvesti, razen če možna korist nedvomno odtehta tveganje.
English: On average, approximately 20% (range = 5.6 to 35.1) of the amount of lamotrigine present in the body was eliminated during a 4-hour hemodialysis session.
Slovenian: V povprečju se je med 4-urno hemodializo izločilo približno 20 % (območje: od 5,6 do 35,1) v telesu prisotne količine lamotrigina.
English: In tests designed to evaluate the central nervous system effects of medicinal products, the results obtained using doses of 240 mg lamotrigine administered to healthy volunteers did not differ from placebo, whereas both 1000 mg phenytoin and 10 mg diazepam each significantly impaired fine visual motor co-ordination and eye movements, increased body sway and produced subjective sedative effects.
Slovenian: V testih za oceno učinkov zdravil na osrednje živčevje se učinki 240 mg odmerkov lamotrigina pri zdravih prostovoljcih niso razlikovali od učinkov placeba, odmerka 1000 mg fenitoina oz. 10 mg diazepama pa sta pomembno poslabšala fino vizualno-motorično koordinacijo in gibe oči, povečala nihanje telesa in povzročila subjektivne sedativne učinke.
English: The risk of congenital malformations is increased by a factor of 2 to 3 in the offspring of mothers treated with AEDs compared with the expected incidence in the general population of approximately 3%.
Slovenian: Pri otrocih mater, zdravljenih z antiepileptiki, je tveganje za kongenitalne malformacije 2- do 3-krat večje od pričakovane incidence med prebivalstvom na splošno, ki je približno 3 %.
English: 500 mg/day has been required by some patients to achieve desired response
Slovenian: Nekateri bolniki so za želeni odziv potrebovali 500 mg/dan.
English: In a study of healthy volunteers, coadministration of felbamate (1200 mg twice daily) with lamotrigine (100 mg twice daily for 10 days) appeared to have no clinically relevant effects on the pharmacokinetics of lamotrigine.
Slovenian: V študiji zdravih prostovoljcev sočasna uporaba felbamata (1200 mg dvakrat na dan) in lamotrigina (100 mg dvakrat na dan 10 dni) ni klinično pomembno vplivala na farmakokinetiko lamotrigina.
English: The other side is marked with two overlapping super-ellipses at right angles.
Slovenian: Druga stran tablete pa je označena z dvema pravokotno postavljenima prekrivajočima se superelipsama.
English: White to off-white round tablet with a blackcurrant odour.
Slovenian: Bele do umazano bele okrogle tablete z vonjem po črnem ribezu.
English: • a high temperature (fever), flu-like symptoms or drowsiness
Slovenian: • zvišana telesna temperatura, gripi podobni simptomi ali zaspanost
English: Lamictal also treats bipolar disorder.
Slovenian: Lamictal zdravi tudi bipolarno motnjo
English: • changes which may show up in blood tests - including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, neutropenia, agranulo-cytosis), reduced numbers of platelets (thrombocytopenia), reduced numbers of all these types of cell (pancytopenia), and a disorder of the bone marrow called aplastic anaemia
Slovenian: • spremembe, ki se lahko pokažejo pri preiskavah krvi, med njimi zmanjšano število rdečih krvnih celic (anemija), zmanjšano število belih krvnih celic (levkopenija, nevtropenija, agranulocitoza),
English: (Starter pack 42 tablets, monotherapy - calender pack showing day numbers): 1 2 3 4 5 6 7 (one pocket)
Slovenian: (Začetno pakiranje z 42 tabletami, monoterapija - koledarsko pakiranje z označenimi številkami dni): 1 2 3 4 5 6 7 (en žepek)
English: What Lamictal tablets contain
Slovenian: Kaj vsebujejo tablete Lamictal
English: If the calculated daily dose in patients taking valproate is less than 2.5 mg, then Lamictal should not be administered.>
Slovenian: Če je izračunani dnevni odmerek za bolnike, ki jemljejo valproat, manjši od 2,5 mg, Lamictala ne smete uporabljati.>
English: The transition regimen involves escalating the dose of lamotrigine to a maintenance stabilisation dose over six weeks (Table 3) after which other psychotropic medicinal products and/or AEDs can be withdrawn, if clinically indicated (Table 4).
Slovenian: V preglednici 3 je opisan režim 6-tedenskega zviševanja odmerka lamotrigina do vzdrževalnega stabilizacijskega odmerka (preglednica 3), ko je mogoče ukiniti zdravljenje s psihotropnimi zdravila in/ali antiepileptiki, če je to klinično indicirano (preglednica 4).
English: The overall risk of rash, appears to be strongly associated with:
Slovenian: Celotno tveganje za izpuščaj jemočno povezano z:
English: • an unusual skin reaction, such as redness or rashes
Slovenian: • nenavadna reakcija na koži, npr. pordelost ali izpuščaj,
English: DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA {MM. LLLL} [Izpolni država članica]
English: Lamictal is not indicated for the acute treatment of manic or depressive episodes”.
Slovenian: Zdravilo Lamictal ni indicirano za akutno zdravljenje maničnih ali depresivnih epizod“.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {DD month YYYY} [To be completed nationally]
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET {DD. mesec LLLL} [Izpolni država članica]
English: The most frequently reported defects are cleft lip, cardiovascular malformations and neural tube defects.
Slovenian: Najpogosteje opisane malformacije so heiloshiza, malformacije srca in ožilja in okvara nevralne cevi.
English: This dosage regimen should be used when valproate is added regardless of any concomitant medicinal products
Slovenian: Ta režim odmerjanja morate uporabiti po dodatku valproata, ne glede na morebitna sočasno uporabljana zdravila
English: If the calculated daily dose in patients taking valproate is less than 1 mg, then Lamictal should not be administered.>
Slovenian: Če je izračunani dnevni odmerek za bolnike, ki jemljejo valproat, manjši od 1 mg, Lamictala ne smete uporabljati.>
English: If you are taking Lamictal for bipolar disorder Lamictal may take some time to work, so you are unlikely to feel better straight away.
Slovenian: Pri zdravilu Lamictal lahko mine nekaj časa, preden začne delovati, zato ni verjetno, da se boste takoj počutili bolje.
English: Lamictal does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila Lamictal niso potrebna posebna navodila.
English: hypersensitivity syndrome** (including such symptoms as, fever, lymphadenopathy, facial oedema, abnormalities of the blood and liver, disseminated intravascular coagulation, multi-organ failure).
Slovenian: preobčutljivostni sindrom** (vključno s simptomi, kot so zvišana telesna temperatura, limfadenopatija, edem obraza, nepravilnosti krvi in jeter, diseminirana intravaskularna koagulacija, večorganska odpoved)
English: Although the number of suicidal ideation and behaviour events was too low (6/1073 [0.6%] on lamotrigine and 2/805 [0.3%] on placebo) to allow a definitive comparison between treatment groups, the relative rate reported from this lamotrigine analysis is consistent with the reported class effect for AEDs (see section 4.4).
Slovenian: Število primerov samomorilnega razmišljanja in vedenja je bilo sicer premajhno (6/1073 [0,6 %] z lamotriginom in 2/805 [0,3 %] s placebom), da bi omogočilo dokončno primerjavo med terapevtskima skupinama.
English: Effects of lamotrigine on hormonal contraceptive efficacy An interaction study in 16 healthy volunteers has shown that when lamotrigine and a hormonal contraceptive (ethinyloestradiol/levonorgestrel combination) are administered in combination, there is a modest increase in levonorgestrel clearance and changes in serum FSH and LH (see section 4.5).
Slovenian: Vpliv lamotrigina na učinkovitost hormonskih kontraceptivov Študija medsebojnega delovanja pri 16 zdravih prostovoljkah je pokazala, da sočasna uporaba lamotrigina in hormonskega kontraceptiva (kombinacije etinilestradiola/levonorgestrela) povzroči zmerno povečanje očistka levonorgestrela in spremembe FSH in LH v serumu (glejte poglavje 4.5).
English: If you are using a hormonal contraceptive like the Pill, your doctor may take samples of your blood to check the level of Lamictal.
Slovenian: Če uporabljate hormonsko kontracepcijo, npr. kontracepcijske tablete, vas bo zdravnik morda napotil na preglede krvi, da bo preveril koncentracijo zdravila Lamictal.
English: Evidence from in vitro studies indicates that lamotrigine does not displace other AEDs from protein binding sites.
Slovenian: Ugotovitve študij in vitro kažejo, da lamotrigin ne izpodriva drugih antiepileptikov z beljakovinskih vezavnih mest.
English: Lamictal should not be given to people aged under 18 years to treat bipolar disorder.
Slovenian: Zdravila Lamictal za zdravljenje bipolarne motnje ne smejo dobivati bolniki, mlajši od 18 let.
English: Following titration, higher maintenance doses of lamotrigine (by as much as two-fold) will be needed in most cases to attain a maximal therapeutic response.
Slovenian: Po titriranju so večinoma potrebni večji (celo dvakratni) vzdrževalni odmerki lamotrigina, da je dosežen največji terapevtski odziv.
English: In the subset of epilepsy trials, there were no statistically significant differences in the rate of events between lamotrigine and placebo.
Slovenian: V podskupini preskušanj pri epilepsiji se delež teh pojavov med lamotriginom in placebom ni statistično značilno razlikoval.
English: Certain AEDs (such as phenytoin, carbamazepine, phenobarbitone and primidone) which induce hepatic drug-metabolising enzymes induce the glucuronidation of lamotrigine and enhance the metabolism of lamotrigine.
Slovenian: Nekateri antiepileptiki (npr. fenitoin, karbamazepin, fenobarbiton in primidon), ki inducirajo jetrne encime za presnovo zdravil, inducirajo glukuronidacijo lamotrigina in pospešijo njegovo presnovo.
English: 1 - 10 mg/kg/day, although some patients have required higher doses (up to 15 mg/kg/day) to achieve desired response (once a day or two divided doses)
Slovenian: 1-10 mg/kg/dan, vendar so nekateri bolniki za želeni odziv potrebovali večje odmerke (do 15 mg/kg/dan).
English: In single dose studies in subjects with end stage renal failure, plasma concentrations of lamotrigine were not significantly altered.
Slovenian: V študijah posamičnega odmerka pri preiskovancih z odpovedjo ledvic v zadnji fazi, se plazemska koncentracija lamotrigina ni pomembno spremenila.
English: There is no evidence that lamotrigine causes clinically significant induction or inhibition of hepatic oxidative drug-metabolising enzymes, and interactions between lamotrigine and medicinal products metabolised by cytochrome P450 enzymes are unlikely to occur.
Slovenian: Ni dokazov, da bi lamotrigin klinično pomembno induciral ali zaviral jetrne oksidacijske encime za presnovo zdravil, zato niso verjetne interakcije med lamotriginom in zdravili, ki se presnavljajo z encimi citokroma P450.
English: • phenytoin, primidone or phenobarbitone, used to treat epilepsy
Slovenian: • fenitoin, primidon ali fenobarbiton, ki se uporabljajo za zdravljenje epilepsije,
English: Lamictal is given as adjunctive therapy but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaut syndrome.
Slovenian: Zdravilo Lamictal se daje kot dopolnilno zdravljenje, lahko pa je tudi začetno antiepileptično zdravilo (AED) pri Lennox-Gastautovem sindromu.
English: Austria
Slovenian: Austrija
English: • skin rashes or redness
Slovenian: • izpuščaj ali pordelost kože
English: After birth lamotrigine levels may increase rapidly with a risk of dose-related adverse events.
Slovenian: Po porodu se lahko koncentracija lamotrigina hitro poveča in obstaja tveganje za pojav neželenih učinkov, ki so odvisni od odmerka.
English: Study of the effect of lamotrigine on cardiac conduction
Slovenian: Raziskava vpliva lamotrigina na prevajanje v srcu
English: Someone who has taken too much Lamictal may have any of these symptoms:
Slovenian: Če vzamete preveč zdravila Lamictal, se vam lahko pojavi kateri od naslednjih simptomov:
English: lamotrigine
Slovenian: lamotrigin
English: Animal experiments did not reveal impairment of fertility by lamotrigine.
Slovenian: Poskusi na živalih niso pokazali vpliva lamotrigina na poslabšanje plodnosti.
English: Luxembourg GlaxoSmithKline s.a. Rue du Tilleul 13, B86
Slovenian: Luksemburg GlaxoSmithKline s.a. Rue du Tilleul 13, B86
English: nystagmus.
Slovenian: nistagmus.
English: Table 3: Adults aged 18 years and above - recommended dose escalation to the maintenance total daily stabilisation dose in treatment of bipolar disorder
Slovenian: Preglednica 3: Odrasli od 18. leta naprej - priporočeno zviševanje odmerka do vzdrževalnega celotnega dnevnega stabilizacijskega odmerka pri zdravljenju bipolarne motnje
English: Interactions involving other psychoactive agents
Slovenian: Medsebojno delovanje s psihoaktivnimi snovmi
English: 25, 50, 100 and 200 mg tablets, 5, 25, 50, 100 and 200 mg dispersible/chewable tablets: Three years.
Slovenian: 25-, 50-, 100- in 200 mg tablete, 5-, 25-, 50-, 100- in 200 mg disperzibilne/žvečljive tablete: 3 leta.
English: One side has a bevelled edge and is marked “LTG” above the number 2.
Slovenian: Na eni strani tablete s poševnim robom je napis "LTG" nad številko 2.
English: However, during prolonged human dosing, lamotrigine did not induce significant changes in the haemoglobin concentration, mean corpuscular volume, or serum or red blood cell folate concentrations up to 1 year or red blood cell folate concentrations for up to 5 years.
Slovenian: Vendar lamotrigin pri človeku med dolgotrajno uporabo do 1 leta ni pomembno spremenil koncentracije hemoglobina, povprečnega korpuskularnega volumna, koncentracije folata v eritrocitih ali v serumu, v obdobju 5 let pa ne koncentracije folata v eritrocitih.
English: • unexpected bleeding or bruising, or your fingers turning blue
Slovenian: • nepričakovana krvavitev ali podplutbe, ali pomodrelost prstov
English: Fertility Animal experiments did not reveal impairment of fertility by lamotrigine (see section 5.3).
Slovenian: Plodnost Poskusi na živalih niso pokazali, da bi lamotrigin vplival na plodnost (glejte poglavje 5.3).
English: Discontinuation of Lamictal in patients with bipolar disorder In clinical trials, there was no increase in the incidence, severity or type of adverse reactions following abrupt termination of lamotrigine versus placebo.
Slovenian: Ukinitev zdravila Lamictala pri bolnikih z bipolarno motnjo V kliničnih preskušanjih po nenadni prekinitvi lamotrigina niso ugotovili večje incidence, resnosti ali vrste neželenih učinkov kot pri placebu.
English: Mean clearances were 0.42 mL/min/kg (chronic renal failure), 0.33 mL/min/kg (between hemodialysis) and 1.57 mL/min/kg (during hemodialysis), compared with 0.58 mL/min/kg in healthy volunteers.
Slovenian: Povprečni očistki so bili 0,42 ml/min/kg (kronična odpoved ledvic), 0,33 ml/min/kg (v obdobju med hemodializami) in 1,57 ml/min/kg (med samo hemodializo).
English: Myoclonic seizures may be worsened by lamotrigine.
Slovenian: Lamotrigin lahko poslabša mioklonične napade.
English: Multiple oral doses of bupropion had no statistically significant effects on the single dose pharmacokinetics of lamotrigine in 12 subjects and had only a slight increase in the AUC of lamotrigine glucuronide.
Slovenian: Večkratni peroralni odmerki bupropiona pri 12 preiskovancih niso statistično značilno vplivali na farmakokinetiko lamotrigina po posamičnem odmerku, AUC lamotrigin-glukuronida pa se je le rahlo povečala.
English: hepatic failure, hepatic dysfunction, increased liver function tests.
Slovenian: odpoved jeter, moteno delovanje jeter, zvišani testi jetrnega delovanja.
English: Valproate, which inhibits the glucuronidation of lamotrigine, reduces the metabolism of lamotrigine and increases the mean half-life of lamotrigine nearly two-fold.
Slovenian: Valproat zavre glukuronidacijo lamotrigina, zmanjša njegovo presnovo in skoraj dvakrat podaljša povprečni razpolovni čas lamotrigina.
English: Lamictal is not indicated for the acute treatment of manic or depressive episodes.
Slovenian: Lamictal ni indiciran za akutno zdravljenje maničnih ali depresivnih epizod.
English: Lamictal is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy (see section 4.4).
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba Lamictala ni priporočljiva pri otrocih do 18. leta starosti (glejte poglavje 4.4).
English: The proportion of subjects with treatment failure was 84% (16/19 subjects) in the placebo arm and 58% (11/19 subjects) in the lamotrigine arm.
Slovenian: V kraku s placebom je bil delež preiskovancev, pri katerih zdravljenje ni bilo uspešno, 84 % (16/19 preiskovancev), v kraku z lamotriginom pa 58 % (11/19 preiskovancev).