natgillin/translations-raw huggingface dataset:
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.
57 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.
Steady-state trough plasma concentrations of lamotrigine were not affected by concomitant pregabalin (200 mg, 3 times daily) administration.
Sočasna uporaba pregabalina (200 mg 3- krat na dan) ni vplivala na plazemsko koncentracijo lamotrigina v stanju dinamičnega ravnovesja.
Administration of lamotrigine resulted in a 15% increase in topiramate concentrations.
Uporaba lamotrigina je povzročila 15% povečanje koncentracije topiramata.
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.
The pharmacokinetics of lithium after 2 g of anhydrous lithium gluconate given twice daily for six days to 20 healthy subjects were not altered by co-administration of 100 mg/ day lamotrigine.
Sočasna uporaba 100 mg lamotrigina na dan ni spremenila farmakokinetike litija pri 20 zdravih preiskovancih, ki so šest dni jemali po 2 g brezvodnega litijevega glukonata dvakrat na dan.
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.
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.
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%.
In vitro experiments indicated that the formation of lamotrigine's primary metabolite, the 2-N-glucuronide, was minimally inhibited by co-incubation with amitriptyline, bupropion, clonazepam, haloperidol or lorazepam.
Poskusi in vitro kažejo, da sočasna inkubacija z amitriptilinom, bupropionom, klonazepamom, haloperidolom ali lorazepamom le minimalno inhibira primarni presnovek lamotrigina, 2- N- glukuronida.
These experiments also suggested that metabolism of lamotrigine was unlikely to be inhibited by clozapine, fluoxetine, phenelzine, risperidone, sertraline or
Ti poskusi tudi kažejo, da ni pričakovati inhibicije presnove lamotrigina s klozapinom, fluoksetinom, fenelzinom, risperidonom, sertralinom ali trazodonom.
Effect of hormonal contraceptives on lamotrigine pharmacokinetics In a study of 16 female volunteers, dosing with 30 µg ethinyloestradiol/ 150 µg levonorgestrel in a combined oral contraceptive pill caused an approximately two-fold increase in lamotrigine oral clearance, resulting in an average 52% and 39% reduction in lamotrigine AUC and Cmax, respectively.
Vpliv hormonskih kontraceptivov na farmakokinetiko lamotrigina V študiji 16 prostovoljk je uporaba kombiniranih kontracepcijskih tablet s 30 µg etinilestradiola/ 150 µg levonorgestrela povzročila približno dvakratno povečanje očistka peroralnega lamotrigina, to pa je povzročilo povprečno 52% zmanjšanje AUC in povprečno 39% zmanjšanje Cmax lamotrigina.
Serum lamotrigine concentrations increased during the course of the week of inactive treatment (including the "pill-free" week), with pre-dose concentrations at the end of the week of inactive treatment being, on average, approximately two-fold higher than during co-therapy (see section 4.4).
Serumska koncentracija lamotrigina se je v tednu neaktivnega zdravljenja (vključno s "tednom brez tablet") povečala.
No adjustments to the recommended dose escalation guidelines for lamotrigine should be necessary solely based on the use of hormonal contraceptives, but the maintenance dose of lamotrigine will need to be increased or decreased in most cases when starting or stopping hormonal contraceptives (see section 4.2).
Uporaba hormonskih kontraceptivov sama po sebi ne zahteva prilagoditve priporočenih smernic za zviševanje odmerka lamotrigina, večinoma pa je po začetku ali prenehanju jemanja hormonskih kontraceptivov treba zvišati ali znižati vzdrževalni odmerek lamotrigina (glejte poglavje 4. 2).
A modest increase in oral clearance of the levonorgestrel component was observed, resulting in an average 19% and 12% reduction in levonorgestrel AUC and Cmax, respectively.
Ugotovili so zmerno povečanje peroralnega očistka levonorgestrela, kar je povzročilo povprečno 19% zmanjšanje AUC in povprečno 12% zmanjšanje Cmax levonorgestrela.
The impact of the modest increase in levonorgestrel clearance, and the changes in serum FSH and LH, on ovarian ovulatory activity is unknown (see section 4.4).
Vpliv zmernega povečanja očistka levonorgestrela in sprememb FSH in LH v serumu na ovulacijsko aktivnost jajčnikov ni znan (glejte poglavje 4. 4).
The effects of doses of lamotrigine other than 300 mg/ day have not been studied and studies with other female hormonal preparations have not been conducted.
Učinki ostalih odmerkov lamotrigina, razen 300 mg/ dan, niso bili raziskani in študije z drugimi ženskimi hormonskimi pripravki niso bile izvedene.
In patients receiving concomitant therapy with rifampicin, the appropriate treatment regimen should be used (see section 4.2).
Pri bolnikih, ki sočasno prejemajo rifampicin, je treba uporabiti ustrezen režim zdravljenja (glejte poglavje 4. 2).
In a study in healthy volunteers, lopinavir/ ritonavir approximately halved the plasma concentrations of lamotrigine, probably by induction of glucuronidation.
V študiji zdravih prostovoljcev je lopinavir/ ritonavir približno prepolovil plazemsko koncentracijo lamotrigina, verjetno z indukcijo glukuronidacije.
In patients receiving concomitant therapy with lopinavir/ ritonavir, the appropriate treatment regimen should be used (see section 4.2).
Pri bolnikih, ki se sočasno zdravijo z lopinavirjem/ ritonavirjem, je treba uporabiti ustrezen režim zdravljenja (glejte poglavje 4. 2).
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%.
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%.
62 Risk related to lamotrigine
Tveganje, povezano z lamotriginom
Pregnancy Epidemiological studies involving in total approximately 2000 women exposed to lamotrigine monotherapy during pregnancy cannot exclude an increased risk for congenital malformations.
S študijo ne morejo izključiti povečanega tveganja za kongenitalne malformacije.
Animal studies have shown developmental toxicity (see section 5.3).
Študije na živalih so pokazale toksične učinke na razvoj (glejte poglavje 5. 3).
Lamotrigine has a slight inhibitory effect on dihydrofolic acid reductase and could therefore theoretically lead to an increased risk of embryofoetal damage by reducing folic acid levels (see section 4.4).
Lamotrigin rahlo zavira dihidrofolat- reduktazo in bi tako lahko z zmanjšanjem koncentracije folne kisline teoretično povzročil tveganje za embrio- fetalno okvaro (glejte poglavje 4. 4).
Physiological changes during pregnancy may affect lamotrigine levels and/ or therapeutic effect.
59 Fiziološke spremembe med nosečnostjo lahko vplivajo na koncentracijo lamotrigina in/ ali njegov terapevtski učinek.
Lactation Data indicate that lamotrigine passes into breast milk.
Dojenje Podatki kažejo, da lamotrigin prehaja v materino mleko.
Fertility Animal experiments did not reveal impairment of fertility by lamotrigine (see section 5.3).
Plodnost Poskusi na živalih niso pokazali, da bi lamotrigin vplival na plodnost (glejte poglavje 5. 3).
Two volunteer studies have demonstrated that the effect of lamotrigine on fine visual motor co-ordination, eye movements, body sway and subjective sedative effects did not differ from placebo.
Dve študiji s prostovoljci sta pokazali, da se vpliv lamotrigina na fino vizualno- motorično koordinacijo, gibe oči, nihanje telesa in subjektivne sedativne učinke ne razlikuje od placeba.
The following convention has been utilised for the classification of undesirable effects: - Very common (> 1/ 10), common (> 1/ 100 ,< 1/10), uncommon (> 1/ 1000 ,< 1/100), rare (> 1/ 10,000, < 1/ 1000), very rare (< 1/ 10,000).
Zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1000, < 1/ 100), redki (≥ 1/ 10. 000, < 1/ 1000), zelo redki (< 1/ 10. 000).
63 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
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 **).
hypersensitivity syndrome** (including such symptoms as, fever, lymphadenopathy, facial oedema, abnormalities of the blood and liver, disseminated intravascular coagulation, multi-organ failure).
preobčutljivostni sindrom ** (vključno s simptomi, kot so zvišana telesna temperatura, limfadenopatija, edem obraza, nepravilnosti krvi in jeter, diseminirana intravaskularna koagulacija, večorganska odpoved)
**Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema and abnormalities of the blood and liver.
60 ** O izpuščaju so poročali tudi kot o delu preobčutljivostnega sindroma, ki ga spremljajo različne kombinacije sistemskih simptomov, vključno z zvišano telesno temperaturo, limfadenopatijo, edemom obraza in nepravilnostmi krvi in jeter.
If such signs and symptoms are present, the patient should be evaluated immediately and Lamictal discontinued if an alternative aetiology cannot be established.
Če ni mogoče ugotoviti druge etiologije, je treba uporabo Lamictala prekiniti.
aggression, irritability. confusion, hallucinations, tics.
agresivnost, razdražljivost. zmedenost, halucinacije, tiki.
Nervous system disorders During monotherapy clinical trials:
Bolezni živčevja
headache. somnolence, dizziness, tremor, insomnia. ataxia. nystagmus.
glavobol. zaspanost, omotica, tremor, nespečnost. ataksija. nistagmus.
During other clinical experience:
Druge klinične izkušnje:
somnolence, ataxia, dizziness, headache. nystagmus, tremor, insomnia. agitation, unsteadiness, movement disorders, worsening of Parkinson's disease, extrapyramidal effects, choreoathetosis, increase in seizure frequency.
zaspanost, ataksija, omotica, glavobol. nistagmus, tremor, nespečnost. agitacija, negotovost pri gibanju, motnje gibanja, poslabšanje Parkinsonove bolezni, ekstrapiramidalni učinki, horeoatetoza, pogostejši epileptični napadi.
There have been reports that lamotrigine may worsen parkinsonian symptoms in patients with pre-existing Parkinson’ s disease, and isolated reports of extrapyramidal effects and choreoathetosis in patients without this underlying condition.
Opisani so tudi posamezni primeri ekstrapiramidnih učinkov in horeoatetoze pri bolnikih brez te bolezni.
Eye disorders During monotherapy clinical trials:
Očesne bolezni Klinična preskušanja z monoterapijo:
diplopia, blurred vision. conjunctivitis.
diplopija, zamegljen vid. konjunktivitis.
Gastrointestinal disorders During monotherapy clinical trials:
Bolezni prebavil
64 Common:
Pogosti:
nausea, vomiting, diarrhoea.
navzeja, bruhanje, driska.
nausea, vomiting. diarrhoea.
navzeja, bruhanje. driska.
skin rash.
kožni izpuščaj.
Stevens– Johnson Syndrome. toxic epidermal necrolysis.
Stevens– Johnsonov sindrom. toksična epidermalna nekroliza.
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.
61 V dvojno slepih kliničnih preskušanjih pri odraslih je imelo izpuščaje do 10% bolnikov, ki so jemali lamotrigin, in 5% bolnikov, ki so jemali placebo.
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 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).
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).
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).
- high initial doses of lamotrigine and exceeding the recommended dose escalation of
- visokimi začetnimi odmerki lamotrigina in prekoračenjem priporočenega zviševanja odmerka
lamotrigine therapy (see section 4.2)
lamotrigina (glejte poglavje 4. 2),
- concomitant use of valproate (see section 4.2).
- sočasno uporabo valproata (glejte poglavje 4. 2).
Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms (see Immune system disorders**).
O izpuščaju so poročali tudi kot o delu preobčutljivostnega sindroma, ki ga spremljajo različne kombinacije sistemskih simptomov (glejte Bolezni imunskega sistema **).
Musculoskeletal and connective tissue disorders Very rare:
Bolezni mišično- skeletnega sistema in vezivnega tkiva Zelo redki:
General disorders Common:
Splošne težave in Pogosti:
and administration site conditions tiredness.
spremembe na mestu aplikacije utrujenost.
Nervous system disorders During bipolar disorder clinical trials:
Bolezni živčevja Klinična preskušanja pri bipolarni motnji:
headache. agitation, somnolence, dizziness.
glavobol. agitiranost, zaspanost, omotica.
Gastrointestinal disorders During bipolar disorder clinical trials:
Klinična preskušanja pri bipolarni motnji:
Skin and subcutaneous tissue disorders During bipolar disorder clinical trials:
Bolezni kože in podkožja Klinična preskušanja pri bipolarni motnji:
skin rash.
izpuščaj.
Stevens– Johnson Syndrome.
Stevens– Johnsonov sindrom.
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.
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.
Musculoskeletal and connective tissue disorders During bipolar disorder clinical trials:
Bolezni mišično- skeletnega sistema in vezivnega tkiva Klinična preskušanja pri bipolarni motnji:
General disorders and administration site conditions During bipolar disorder clinical trials:
Klinična preskušanja pri bipolarni motnji:
Acute ingestion of doses in excess of 10 to 20 times the maximum therapeutic dose has been reported.
Poročali so o akutnem zaužitja odmerkov, ki so za 10 - do 20- krat presegali največji terapevtski odmerek.
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).
Pharmacotherapeutic group: other antiepileptics, ATC code:
Oznaka ATC:
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
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.
66 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.
10 mg diazepama pa sta pomembno poslabšala fino vizualno- motorično koordinacijo in gibe oči, povečala nihanje telesa in povzročila subjektivne sedativne učinke.
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.
V drugi študiji so posamični peroralni odmerki 600 mg karbamazepina pomembno poslabšali fino vizualno - motorično 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.
Serum levels were measured at the end of week 2 of titration and the subsequent dose either reduced or not increased if the concentration exceeded 0.41 µg/ mL, the expected concentration in adults at this time point.
Nadaljnji odmerek so potem bodisi zmanjšali ali ga niso povečali, če je koncentracija presegla 0, 41 µg/ ml, kar je pričakovana koncentracija pri odraslih ob tem času.
Dose reductions of up to 90% were required in some patients at the end of week 2.
Nekaterim bolnikom je bilo treba odmerek na koncu 2. tedna zmanjšati do 90%.
Thirty-eight responders (> 40% decrease in seizure frequency) were randomised to placebo or continuation of lamotrigine.
V kraku s placebom je bil delež
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.
63 preiskovancev, pri katerih zdravljenje ni bilo uspešno, 84% (16/ 19 preiskovancev), v kraku z lamotriginom pa 58% (11/ 19 preiskovancev).
The difference was not statistically significant:
Razlika ni bila statistično značilna:
26.3%, CI95% -2.6 %< > 50.2%, p=0.07.
26, 3%, 95% IZ: - 2, 6% < > 50, 2%, p = 0, 07.
A total of 256 subjects between 1 to 24 months of age have been exposed to lamotrigine in the dose range 1 to 15 mg/ kg/ day for up to 72 weeks.
Lamotriginu v odmerkih od 1 do 15 mg/ kg/ dan je bilo do 72 tednov izpostavljenih skupaj 256 preiskovancev, starih od 1 do 24 mesecev.
The safety profile of lamotrigine in children aged 1 month to 2 years was similar to that in older children except that clinically significant worsening of seizures (> =50%) was reported more often in children under 2 years of age (26%) as compared to older children (14%).
Varnostni profil lamotrigina pri otrocih, starih od 1 meseca do 2 let, je bil podoben kot pri starejših otrocih, le da je bilo klinično pomembno poslabšanje napadov (> = 50%) pogostejše pri otrocih, mlajših od 2 let (26%), kot pri starejših otrocih (14%).
Clinical efficacy and safety in Lennox-Gastaut syndrome
Klinična učinkovitost in varnost pri Lennox- Gastautovem sindromu
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.
Study SCAB2003 was a multicentre, double-blind, double dummy, placebo and lithium-controlled, randomised fixed dose evaluation of the long-term prevention of relapse and recurrence of depression and/ or mania in patients with bipolar I disorder who had recently or were currently experiencing a major depressive episode.
Ocenjevala je dolgotrajno preprečevanje recidiva in ponovitve depresije in/ ali manije pri bolnikih z bipolarno motnjo I, ki so trenutno imeli hujšo depresivno epizodo.
Once stabilised using lamotrigine monotherapy or adjunctive therapy, patients were randomly assigned into one of five treatment groups: lamotrigine (50, 200, 400 mg/ day), lithium (serum levels of 0.8 to 1.1 mMol/ L) or placebo for a maximum of 76 weeks (18 months).
Ko se je stanje z monoterapijo z lamotriginom ali dodatno terapijo stabilizirano, so bolnike naključno razvrstili v eno od petih terapevtskih skupin: lamotrigin (50, 200, 400 mg/ dan), litij (serumske koncentracije od 0, 8 do 1, 1 mmol/ l) ali placebo za največ 76 tednov (18 mesecev).
Study SCAB2006 had a similar design as study SCAB2003, but differed from study SCAB2003 in evaluating a flexible dose of lamotrigine (100 to 400 mg/ day) and including patients with bipolar I disorder who had recently or were currently experiencing a manic episode.
Rezultati so prikazani v preglednici 7.
The results are shown in Table 7.
Preglednica 7:
Summary of results from studies investigating the efficacy of lamotrigine in the prevention of mood episodes in patients with bipolar I disorder
Povzetek rezultatov študij, ki sta raziskovali učinkovitost lamotrigina za preprečevanje razpoloženjskih epizod pri bolnikih z bipolarno motnjo I
‘ Proportion’ of patients being event free at week 76
"Delež" bolnikov, ki so bili 76. teden brez dogodka
Study SCAB2003 Bipolar I
Študija SCAB2003 Bipolarna I
Inclusion criterion
Merilo za vključitev
Major depressive episode
hujša depresivna epizoda
Major manic episode
hujša manična epizoda
Placebo Lamotrigine Lithium
Placebo Lamotrigin
Intervention free p-value Log rank test
Brez posredovanja
0.22 0.21 0.004 0.006
0, 12 0, 17
0.12 0.17 0.24 - 0.023 0.006
p vrednost (log test)
0.04 -
0, 006
Depression free
Brez depresije
0.51 0.46
0, 51
0.41 0.82
0, 46
0.71
0, 41
p-value Log rank
- rank
-value Log rank 0.047 0.209 -
Brez manije
0.015
0, 67
0.167
0, 53
-
0, 64
test
0, 37
Free of mania p-value Log rank test
p vrednost (log test)
0.70 0.339
- rank
0.86 0.026
0, 339
0.67 -
0, 026
0.53 0.280
0, 280
0.64 0.006
0, 006
0.37 -
-
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.
Kar zadeva čas do manične/ hipomanične ali mešane epizode, razlika med zdravljenji ni bila statistično značilna.
The efficacy of lamotrigine in combination with mood stabilisers has not been adequately studied.
64 Učinkovitost lamotrigina v kombinaciji s stabilizatorji razpoloženja ni ustrezno raziskana.
The incidence of suicidal ideation and behaviour was evaluated in a pooled analysis of placebo-controlled clinical trials with lamotrigine involving a total of 6467 patients from a number of indications.
Incidenco samomorilnega razmišljanja in vedenja so ocenili v kumulativni analizi s placebom kontroliranih kliničnih preskušanj lamotrigina, ki so skupaj zajela 6. 467 bolnikov z več različnimi indikacijami.
In the subset of bipolar disorder trials, the rate of events was numerically, but not statistically significantly, greater for lamotrigine (29/ 1212 [2.4%]) compared with placebo (19/ 1054 [1.8%]).
V podskupini preskušanj pri bipolarni motnji je bil delež teh pojavov številsko, ne pa tudi statistično značilno večji pri lamotriginu (29/ 1212 [2, 4%]) kot pri placebu (19/ 1054 [1, 8%]).