natgillin/translations-raw huggingface dataset:
The CHMP was of the opinion that lamotrigine is effective in preventing one aspect of mood episodes in Bipolar disorder, depressive episodes, while prevention of manic or hypomanic episodes has not been proven.
CHMP je menil, da je lamotrigin učinkovit pri preprečevanju enega izmed razpoloženjskih stanj pri bipolarni motnji, tj. epizod depresije, medtem ko njegova učinkovitost pri preprečevanju maničnih ali hipomaničnih epizod ni bila dokazana.
In clinical trials in patients with bipolar disorder, the incidence of serious rash is approximately 1 in 1000.
V kliničnih preskušanjih pri bolnikih z bipolarno motnjo je bila incidenca resnih izpuščajev približno 1 na 1000.
Clearance of lamotrigine is primarily metabolic with subsequent elimination of glucuronide-conjugated material in urine.
Očistek lamotrigina je predvsem presnoven, ki se izloči v obliki z glukuronidom konjugiranih snovi v urinu.
The indication will specify that the target population is “Adults and adolescents aged 13 years and above”.
V indikaciji bo navedeno, da so ciljna populacija „Odrasli in mladostniki, stari 13 let in več“.
“Epilepsy
„Epilepsija
Haematological abnormalities may or may not be associated with the hypersensitivity syndrome (see Immune system disorders**).
Hematološke nepravilnosti so lahko povezane s preobčutljivostnim sindromom ali pa tudi ne (glejte Bolezni imunskega sistema**).
The pharmacokinetics of lamotrigine in this age group do not differ significantly from a non-elderly adult population (see section 5.2).
Farmakokinetika lamotrigina se v tej starostni skupini ne razlikuje bistveno od farmakokinetike v mlajši populaciji (glejte poglavje 5.2).
However, accumulation of the glucuronide metabolite is to be expected; caution should therefore be exercised in treating patients with renal failure.
Vendar je treba pričakovati kopičanje glukuronidnega presnovka, zato je pri zdravljenju bolnikov z odpovedjo ledvic potrebna previdnost.
To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed as weight changes occur.
Za zagotovitev vzdrževalnega terapevtskega odmerka, morate nadzorovati telesno težo otrok in odmerek po potrebi prilagoditi ob spremembi telesne teže.
Therapeutic Indications (SPC section 4.1)
Terapevtske indikacije (poglavje 4.1 povzetka glavnih značilnosti zdravila)
The efficacy of lamotrigine in the prevention of mood episodes in patients with bipolar I disorder has been evaluated in two studies.
Učinkovitost lamotrigina za preprečevanje razpoloženjskih epizod pri bolnikih z bipolarno motnjo I so ocenili v dveh študijah.
As the efficacy has been demonstrated for prevention of recurrence only, lamotrigine is not indicated for the acute treatment of manic or depressive episodes.
Ker je bila učinkovitost dokazana samo za preprečevanje ponovitev, lamotrigin ni indiciran za akutno zdravljenje maničnih ali depresivnih epizod.
Maximum dose of 200 mg/day can be used depending on clinical response
Uporabite lahko največji odmerek do 200 mg/dan, odvisno od kliničnega odziva
Initial, escalation and maintenance doses should generally be reduced by approximately 50% in patients with moderate (Child-Pugh grade B) and 75% in severe (Child-Pugh grade C) hepatic impairment.
Na splošno je treba začetne odmerke, zviševanje odmerkov in vzdrževalne odmerke pri bolnikih z zmerno okvaro jeter (Child-Pugh B) zmanjšati za približno 50 %, pri bolnikih s hudo okvaro jeter (Child-Pugh C) pa za 75 %.
200 mg/day Maintain this dose (200 mg/day) Addition of inducers of lamotrigine glucuronidation in patients NOT taking valproate (see section 4.5), depending on original dose of lamotrigine: 200 mg/day
200 mg/dan Vzdržujte ta odmerek (200 mg/dan) Dodatek induktorjev glukuronidacije lamotrigina pri bolnikih, ki NE jemljejo valproata (glejte poglavje 4.5), odvisno od prvotnega odmerka lamotrigina: 200 mg/dan
Dose-related adverse events cannot be excluded.
Z odmerkom povezanih neželenih učinkov ni mogoče izključiti.
the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Lamictal and associated names (see Annex I).
je CHMP priporočil dopolnitev dovoljenj(a) za promet, za katere(ga) so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo podani v Dodatku III za zdravilo Lamictal in z njim povezana imena (glejte Dodatek I).
The predicted serum concentration levels in children of 2 to 26 months were in general in the same range as those in older children, though higher Cmax levels are likely to be observed in some children with a body weight below 10 kg.
Predvidena serumska koncentracija je bila pri otrocih od 2. do 26. meseca na splošno v enakem razponu kot pri starejših otrocih, vendar pa so pri otrocih s telesno težo pod 10 kg verjetnejše višje vrednosti Cmax.
Lamotrigine induces its own metabolism to a modest extent depending on dose.
Lamotrigin v zmerni meri inducira svojo lastno presnovo, odvisno od odmerka.
Lennox-Gastaut Syndrome is a difficult to treat condition and monotherapy is rarely achieved.
Lennox-Gastautov sindrom je težko zdraviti, zato je monoterapija redko izvedljiva.
There are no pharmacokinetic interactions between lamotrigine and pregabalin.
Med lamotriginom in pregabalinom ni farmakokinetičnih interakcij.
Table 7: Summary of results from studies investigating the efficacy of lamotrigine in the prevention of mood episodes in patients with bipolar I disorder
Preglednica 7: Povzetek rezultatov študij, ki sta raziskovali učinkovitost lamotrigina za preprečevanje razpoloženjskih epizod pri bolnikih z bipolarno motnjo I
Like all medicines, Lamictal can cause side effects, but not everyone gets them.
Kot vsa zdravila ima lahko tudi zdravilo Lamictal neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The symptoms listed above can develop into more serious problems, such as organ failure or a very severe skin condition, if they are not treated.
Če našteti simptomi niso zdravljeni, se lahko razvijejo v resnejše težave, npr. odpoved organov ali zelo hudo bolezen kože.
Some medicines interact with Lamictal or make it more likely that you'll have side effects.
Nekatera zdravila medsebojno delujejo z zdravilom Lamictal ali povečajo verjetnost neželenih učinkov.
These events usually resolve when the dose of carbamazepine is reduced.
Ti učinki po zmanjšanju odmerka karbamazepina ponavadi izginejo.
Î Talk to your doctor if you're pregnant, if you might be pregnant, or if you're planning to become pregnant.
Nosečnost in dojenje Î Posvetujte se z zdravnikom, če ste noseči, če domnevate, da ste noseči, ali načrtujete nosečnost.
This dosage regimen should be used when the following are withdrawn:
Ta režim odmerjanja morate uporabiti po ukinitvi naslednjih zdravil:
There are reports in the literature that severe convulsive seizures including status epilepticus may lead to rhabdomyolysis, multiorgan dysfunction and disseminated intravascular coagulation, sometimes with fatal outcome.
V literaturi so opisani primeri, hudih epileptičnih napadov, vključno s status epilepticus-om, ki lahko povzročijo rabdomiolizo, disfunkcijo različnih organov in diseminirano intravaskularno koagulacijo, včasih s smrtnim izidom.
phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ritonavir
fenitoin karbamazepin fenobarbiton primidon rifampicin lopinavir/ritonavir
The rash, usually maculopapular in appearance, generally appears within eight weeks of starting treatment and resolves on withdrawal of Lamictal (see section 4.4).
Izpuščaj, ki je ponavadi makulopapulozen, se na splošno pojavi v osmih tednih po začetku zdravljenja in po prenehanju uporabe Lamictala izgine (glejte poglavje 4.4).
There are reports in the literature of decreased lamotrigine levels when lamotrigine was given in combination with oxcarbazepine.
V literaturi so opisani primeri zmanjšanja koncentracije lamotrigina, ko so prejemali lamotrigin v kombinaciji z okskarbazepinom.
In a study in 10 male volunteers, rifampicin increased lamotrigine clearance and decreased lamotrigine half-life due to induction of the hepatic enzymes responsible for glucuronidation.
V študiji 10 moških prostovoljcev je rifampicin povečal očistek lamotrigina in zmanjšal razpolovni čas lamotrigina zaradi indukcije jetrnih encimov odgovornih za glukuronidacijo.
Lamictal dispersible/chewable tablets may be chewed, dispersed in a small volume of water (at least enough to cover the whole tablet) or swallowed whole with a little water.
Disperzibilne/žvečljive tablete Lamictal lahko bolnik zveči, raztopi v majhni količini vode (vsaj toliko, da prekrije celo tableto) ali pogoltne cele z malo vode.
The results indicate that the drug substance and drug product can be reproducibly manufactured.
Rezultati kažejo, da je pri proizvodnji zdravilne učinkovine in zdravila mogoče zagotoviti ponovljivost.
In six volunteers with kidney failure, 20% of the lamotrigine was removed from the body during a 4-hour haemodialysis session (see section 5.2).
Pri šestih prostovoljcih z odpovedjo ledvic se je med 4-urno dializo izločilo iz telesa 20 % lamotrigina (glejte poglavje 5.2).
When all bipolar disorder studies (controlled and uncontrolled) conducted with lamotrigine are considered, skin rashes occurred in 12% of patients on lamotrigine.
Če upoštevamo vse (kontrolirane in nekontrolirane) študije z lamotriginom pri bipolarni motnji, so se izpuščaji na koži pojavili pri 12 % bolnikov, ki so uporabljali lamotrigin.
Therefore patients should be monitored for signs of suicidality during treatment with Lamictal.
Zato je treba bolnike med zdravljenjem z zdravilom Lamictal nadzirati glede znakov samomorilnosti.
Lamictal and associated names (see Annex I) 25 mg tablets Lamictal and associated names (see Annex I) 50 mg tablets Lamictal and associated names (see Annex I) 100 mg tablets Lamictal and associated names (see Annex I) 200 mg tablets Lamictal and associated names (see Annex I) 2 mg dispersible/chewable tablets Lamictal and associated names (see Annex I) 5 mg dispersible/chewable tablets Lamictal and associated names (see Annex I) 25 mg dispersible/chewable tablets Lamictal and associated names (see Annex I) 50 mg dispersible/chewable tablets Lamictal and associated names (see Annex I) 100 mg dispersible/chewable tablets Lamictal and associated names (see Annex I) 200 mg dispersible/chewable tablets
Lamictal in sorodna imena (glejte Dodatek I) 25 mg tablete Lamictal in sorodna imena (glejte Dodatek I) 50 mg tablete Lamictal in sorodna imena (glejte Dodatek I) 100 mg tablete Lamictal in sorodna imena (glejte Dodatek I) 200 mg tablete Lamictal in sorodna imena (glejte Dodatek I) 2 mg disperzibilne/žvečljive tablete Lamictal in sorodna imena (glejte Dodatek I) 5 mg disperzibilne/žvečljive tablete Lamictal in sorodna imena (glejte Dodatek I) 25 mg disperzibilne/žvečljive tablete Lamictal in sorodna imena (glejte Dodatek I) 50 mg disperzibilne/žvečljive tablete Lamictal in sorodna imena (glejte Dodatek I) 100 mg disperzibilne/žvečljive tablete Lamictal in sorodna imena (glejte Dodatek I) 200 mg disperzibilne/žvečljive tablete
The majority of rashes are mild and self-limiting, however serious rashes requiring hospitalisation and discontinuation of lamotrigine have also been reported.
Večinoma je bil izpuščaj blag in je minil sam od sebe, vendar pa so bili opisani tudi primeri resnih izpuščajev, ki so zahtevali sprejem v bolnišnico in prenehanje zdravljenja z lamotriginom.
Overdose has resulted in symptoms including nystagmus, ataxia, impaired consciousness and coma.
Preveliko odmerjanje je povzročilo simptome, med katerimi so bili nistagmus, ataksija, motnje zavesti in koma.
Î If any of the side effects becomes severe or troublesome, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
Î Če katerikoli neželeni učinek postane hud ali moteč, ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
There have been reports of decreased lamotrigine plasma levels during pregnancy with a potential risk of loss of seizure control.
Poročali so o zmanjšanu plazemske koncentracije lamotrigina med nosečnostjo in s tem povezano tveganje izgube nadzora nad napadi.
In addition, pharmacokinetics of lamotrigine was studied in 12 healthy elderly subjects following a 150 mg single dose.
Proučevali so tudi farmakokinetiko lamotrigina pri 12 zdravih starejših preiskovancih, ki so dobili posamičen odmerek 150 mg.
Î Tell your doctor, and don't take Lamictal.
Î Povejte svojemu zdravniku in ne vzemite zdravila Lamictal.
There is no experience with haemodialysis as treatment of overdose.
Izkušenj s hemodializo pri zdravljenju prevelikega odmerjanja ni.
Twelve volunteers with chronic renal failure, and another six individuals undergoing hemodialysis were each given a single 100 mg dose of lamotrigine.
Dvanajst prostovoljcev s kronično odpovedjo ledvic in drugih šest bolnikov na hemodializi je prejelo posamičen odmerek 100 mg lamotrigina.
GlaxoSmithKline Export Ltd 980 Great West Road Brentford Middlesex
GlaxoSmithKline Export Ltd 980 Great West Road Brentford
The inter-individual variability for oral clearance was high in the group of paediatric patients of 2 to 26 months (47%).
V skupini pediatričnih bolnikov, starih od 2 do 26 mesecev, je bila inter-individualna variabilnost peroralnega očistka velika (47 %).
These have included potentially life-threatening rashes such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.8).
Med temi so bili tudi potencialno smrtno nevarni izpuščaji, npr. Stevens-Johnsonov sindrom in toksična epidermalna nekroliza (glejte poglavje 4.8).
ANNEX IV CONDITION OF THE MARKETING AUTHORISATION(S)
DODATEK IV POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM
Table 4: Adults aged 18 years and above - maintenance stabilisation total daily dose following withdrawal of concomitant medicinal products in treatment of bipolar disorder Once the target daily maintenance stabilisation dose has been achieved, other medicinal products may be withdrawn as shown below.
Preglednica 4: Odrasli od 18. leta naprej - vzdrževalni stabilizacijski celotni dnevni odmerek po prenehanju sočasne uporabe drugih zdravil pri zdravljenju bipolarne motnje Ko je ciljni dnevni vzdrževalni stabilizacijski odmerek dosežen, lahko ukinete druga zdravila, kot je prikazano spodaj.
• aggression or irritability
• napadalnost ali razdražljivost
LIST OF EXCIPIENTS Contains lactose monohydrate - see package leaflet for further information
SEZNAM POMOŽNIH SNOVI Vsebuje laktozo monohidrat - za dodatne informacije glejte navodilo za uporabo.
CONDITIONS CONSIDERED ESSENTIAL FOR THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT INCLUDING PHARMACOVIGILANCE
POGOJI, KI SO BISTVENI ZA VARNO IN UČINKOVITO UPORABO
In a study in healthy adult volunteers, 15 mg olanzapine reduced the AUC and Cmax of lamotrigine by an average of 24% and 20%, respectively.
V študiji zdravih odraslih prostovoljcev je 15 mg olanzapina znižalo AUC lamotrigina za povprečno 24 %, njegovo Cmax pa za 20 %.
Women taking hormonal contraceptives
Ženske, ki jemljejo hormonske kontraceptive
The mean clearance in the elderly (0.39 mL/min/kg) lies within the range of the mean clearance values (0.31 to 0.65 mL/min/kg) obtained in nine studies with non-elderly adults after single doses of 30 to 450 mg.
Povprečni očistek pri starejših (0,39 ml/min/kg) je v območju povprečnih vrednosti očistka (0,31 do 0,65 ml/min/kg), ugotovljenih v devetih študijah mlajših odraslih po posamičnih odmerkih od 30 do 450 mg.
Week 2 Week 3 onwards *
2. teden 3. teden in naprej
In a study of patients with epilepsy, coadministration of zonisamide (200 to 400 mg/day) with lamotrigine (150 to 500 mg/day) for 35 days had no significant effect on the pharmacokinetics of lamotrigine.
V študiji bolnikov z epilepsijo 35-dnevna sočasna uporaba zonisamida (200 do 400 mg/dan) in lamotrigina (150 do 500 mg/dan) ni pomembno vplivala na farmakokinetiko lamotrigina.
As there is individual variation in response to all AED therapy, patients taking Lamictal to treat epilepsy should consult their physician on the specific issues of driving and epilepsy.
Ker se odziv na antiepileptike od bolnika do bolnika razlikuje, se morajo bolniki, ki za zdravljenje epilepsije jemljejo Lamictal, z zdravnikom posvetovati glede specifičnih vprašanj o upravljanju vozil in epilepsiji.
Starting lamotrigine in patients already taking hormonal contraceptives Dose escalation should follow the normal dose recommendation described in the tables.
Uvedba lamotrigina pri bolnicah, ki že jemljejo hormonske kontraceptive Zviševanje odmerka mora biti skladno z običajnimi priporočili za odmerjanje, navedenimi v preglednicah.
If you are taking certain medicines, your doctor may need to check the dose of Lamictal.
Če jemljete določena zdravila, bo zdravnik morda moral prilagoditi odmerek zdravila Lamictal.
Since higher exposure levels could not be tested in animals due to the severity of maternal toxicity, the teratogenic potential of lamotrigine has not been characterised above clinical exposure.
Ker raziskave višjih koncentracij izpostavitve zaradi izrazitih toksičnih učinkov za mater pri živalih niso bile mogoče, zato teratogeni potencial lamotrigina pri odmerkih, višjih od odmerkov pri klinični izpostavitvi, ni bil ovrednoten.
• oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy
• okskarbazepin, felbamat, gabapentin, levetiracetam, pregabalin, topiramat ali zonisamid, ki se uporabljajo za zdravljenje epilepsije,
There was no clinically significant effect of lamotrigine on QT interval compared to placebo.
Lamotrigin v primerjavi s placebom ni klinično pomembno vplival na interval QT.
What Lamictal dispersible/chewable tablets look like and contents of the pack Lamictal dispersible/chewable tablets (all strengths) are white to off-white, and may be slightly mottled.
Izgled Lamictal disperzibilnih/žvečljivih tablet in vsebina pakiranja Lamictal disperzibilne/žvečljive tablete (vse jakosti) so bele do umazano bele barve in so lahko rahlo lisaste.
confusion, hallucinations, tics.
zmedenost, halucinacije, tiki.
The results of pharmacological studies suggest that lamotrigine is a use- and voltage-dependent blocker of voltage gated sodium channels.
Farmakološke študije kažejo, da je lamotrigin od uporabe in napetosti odvisen blokator napetostno aktiviranih natrijevih kanalov.
Take special care with Lamictal Your doctor needs to know before you take Lamictal:
Bodite posebno pozorni pri jemanju zdravila Lamictal Preden vzamete zdravilo Lamictal, morate zdravniku povedati:
300 mg/day in week 6, if necessary increasing to usual target dose of 400 mg/day in week 7, to achieve optimal response (two divided doses)
300 mg/dan v 6. tednuče je potrebno z zviševanjem na običajni ciljni odmerek 400 mg/dan 7. teden, da dosežete optimalen odziv (v dveh deljenih odmerkih)
• changes in liver function, which will show up in blood tests, or liver failure
• spremenjeno delovanje jeter, ki se kaže s spremenjenimi izvidi preiskav krvi, odpoved jeter
Children are more likely to be affected than adults.
Te težave so pri otrocih pogostejše kot pri odraslih.
Starting and stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and TAKING inducers of lamotrigine glucuronidation Adjustment to the recommended maintenance dose of lamotrigine may not be required.
Uvedba in prenehanje uporabe hormonskih kontraceptivov pri bolnicah, ki že jemljejo vzdrževalne odmerke lamotrigina in JEMLJEJO induktorje glukuronidacije lamotrigina Prilagoditev priporočenega vzdrževalnega odmerka lamotrigina ni vedno potrebna.
The skin rashes led to the withdrawal of lamotrigine treatment in 2% of patients.
Zaradi izpuščajev na koži so zdravljenje z lamotriginom prekinili pri 2 % bolnikov.
The CHMP, taking into consideration the assessment of the studies and the recommendation of the SAG concluded that lamotrigine should be used for the prevention of depressive episode in patients with Bipolar I disorder who experience predominantly depressive episodes.
CHMP je ob upoštevanju vrednotenja raziskav in priporočila Znanstvene svetovalne skupine za klinično nevroznanost zaključil, da se lamotrigin lahko uporablja za preprečevanje epizod depresije pri bolnikih z bipolarno motnjo I, pri katerih prevladujejo epizode depresije.
These experiments also suggested that metabolism of lamotrigine was unlikely to be inhibited by clozapine, fluoxetine, phenelzine, risperidone, sertraline or trazodone.
Ti poskusi tudi kažejo, da ni pričakovati inhibicije presnove lamotrigina s klozapinom, fluoksetinom, fenelzinom, risperidonom, sertralinom ali trazodonom.
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.
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.
This leaflet was last approved in {MM/YYYY}.
Navodilo je bilo odobreno {MM. LLLL}.
Pharmacotherapeutic group: other antiepileptics, ATC code: N03AX09.
Oznaka ATC: N03AX09.
diplopia, blurred vision.
diplopija, zamegljen vid.
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).
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).
• clumsiness and lack of co-ordination, affecting their balance (ataxia)
• okornost in pomanjkljiva usklajenost gibov, ki prizadene ravnotežje (ataksija),
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).
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).
If you develop any of these symptoms after you start taking Lamictal, get a doctor's help straight away:
Če se vam po začetku jemanja zdravila Lamictal pojavi katerikoli od naslednjih simptomov, nemudoma poiščite zdravniško pomoč:
Precautions relating to bipolar disorder
Previdnostni ukrepi pri bipolarni motnji
In addition, dose-related undesirable effects should be monitored after birth.
Poleg tega je treba bolnice po porodu kontrolirati glede neželenih učinkov, odvisnih od odmerka.
Intake of folic acid when planning pregnancy and during early pregnancy may be considered.
Priporočeno je uživanje folne kisline med načrtovanjem nosečnosti in v zgodnji nosečnosti.
Serious potentially life-threatening skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's Syndrome) have been reported.
Opisani so bili resni, potencialno smrtno nevarni izpuščaji, vključno s Stevens-Johnsonovim sindromom in toksično epidermalno nekrolizo (Lyellov sindrom).
There are no data for monotherapy in seizures associated with Lennox-Gastaut syndrome.
Na voljo ni podatkov o monoterapiji pri napadih, povezanih z Lennox-Gastautovim sindromom.
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.
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.