natgillin/translations-raw huggingface dataset:
Excipient: Each tablet contains 46.9 mg lactose.
Pomožna snov: Ena tableta vsebuje 46,9 mg laktoze.
Adults and adolescents aged 13 years and above - Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including tonic-clonic seizures.
Odrasli in mladostniki, stari 13 let in več - Dopolnilno zdravljenje ali monoterapija pri delnih napadih in generaliziranih napadih, vključno s tonično-kloničnimi napadi.
They are marked ‘GS CL2' on one side; and ‘5' on the other.
Na eni strani imajo oznako ‘GS CL2', na drugi strani pa oznako ‘5'.
A mood stabilising claim implies the protection from both manic and depressive episodes.
Stabilizacija razpoloženja pomeni preprečevanje maničnih epizod in epizod depresije.
15 17 19 21 23 25 27 (one pocket)
15 17 19 21 23 25 27 (en žepek)
• olanzapine, used to treat mental health problems
• olanzapin, ki se uporablja za zdravljenje težav z duševnim zdravjem,
Intervention free p-value Log rank test
Brez posredovanja p vrednost (log-rank test)
Starter pack of 21 or 42 dispersible/chewable tablets.
Začetno pakiranje z 21 ali 42 disperzibilnimi/žvečljivimi tabletami.
The half-life of lamotrigine is generally shorter in children than in adults with a mean value of approximately 7 hours when given with enzyme-inducing medicinal products such as carbamazepine and phenytoin and increasing to mean values of 45 to 50 hours when co-administered with valproate alone (see section 4.2).
Povprečni razpolovni čas je približno 7 ur, če je lamotrigin uporabljen sočasno z zdravili, ki inducirajo encime (npr. s karbamazepinom in fenitoinom), in se podaljša povprečno za 45 do 50 ur, če je uporabljen sočasno z valproatom (glejte poglavje 4.2).
Packs of 30, 56 or 100 tablets.
Pakiranja s 30, 56 ali 100 tabletami.
What Lamictal dispersible/chewable tablets contain The active substance is lamotrigine.
Kaj vsebujejo Lamictal disperzibilne/žvečljive tablete Zdravilna učinkovina je lamotrigin.
Rare side effects These may affect up to 1 in 1,000 people:
Redki neželeni učinki Pojavijo se lahko pri največ 1 od 1.000 oseb:
25 mg/day (once a day)
25 mg/dan (enkrat na dan)
In rats, enhanced foetal as well as post-natal mortality was observed when lamotrigine was administered during late gestation and through the early post-natal period.
Ob vnosu lamotrigina pri podganah v poznejši dobi gestacije in v zgodnjem postnatalnem obdobju je bila opažena zvišana fetalna in tudi postnatalna umrljivost.
Treatment was initiated in 177 subjects, with a dose titration schedule similar to that of children aged 2 to 12 years.
Potek titriranja odmerka je bil podoben kot pri otrocih od 2. do 12. leta starosti.
HOW TO TAKE LAMICTAL
Kako vzeti odmerek Lamictala
For this patient population, initial doses of lamotrigine should be based on the patient's concomitant medicinal products; reduced maintenance doses may be effective for patients with significant renal functional impairment (see sections 4.2 and 4.4).
V tej populaciji je treba začetne odmerke lamotrigina določiti glede na druga zdravila, ki jih bolnik prejema sočasno; pri bolnikih s pomembno okvaro delovanja ledvic so lahko učinkoviti nižji vzdrževalni odmerki (glejte poglavji 4.2 in
Treatment with antidepressants is associated with an increased risk of suicidal thinking and behaviour in children and adolescents with major depressive disorder and other psychiatric disorders.
Pri otrocih in mladostnikih s hudo depresivno motnjo in drugimi psihiatričnimi motnjami je zdravljenje z antidepresivi povezano z večjim tveganjem za samomorilne misli in samomorilno vedenje.
Interactions involving antiepileptic drugs
Medsebojno delovanje z antiepileptiki
100 mg/day Maintain this dose (100 mg/day)
100 mg/dan Vzdržujte ta odmerek (100 mg/dan)
In clinical trials with lamotrigine adverse reactions of a neurological character such as dizziness and diplopia have been reported.
V kliničnih preskušanjih z lamotriginom so zabeležili nevrološke neželene učinke, npr. omotico in dvojen vid.
The dose adjustments following addition of other psychotropic medicinal products and/or AEDs are also provided below (Table 5).
V preglednici 5 so navedene tudi prilagoditve odmerka ob dodatku drugih psihotropnih zdravil in/ali antiepileptikov.
Interactions involving other medicinal products
Medsebojno delovanje z drugimi zdravili
A small number of people being treated with Lamictal for bipolar disorder or epilepsy have had these thoughts.
Takšno razmišljanje se je pojavilo pri majhnem številu bolnikov, ki so dobivali zdravilo Lamictal zaradi bipolarne motnje ali epilepsije.
Children and adolescents aged 2 to 12 years - Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut syndrome.
Odrasli in mladostniki, stari od 2 do 12 let - Dopolnilno zdravljenje pri delnih napadih in generaliziranih napadih, vključno s tonično-kloničnimi napadi in napadi, povezanimi z Lennox-Gastautovim sindromom.
somnolence, ataxia, dizziness, headache.
zaspanost, ataksija, omotica, glavobol.
In children, the initial presentation of a rash can be mistaken for an infection, physicians should consider the possibility of a reaction to lamotrigine treatment in children that develop symptoms of rash and fever during the first eight weeks of therapy.
Zato morajo zdravniki pri otrocih, ki se jim v prvih osmih tednih zdravljenja pojavijo izpuščaj in zvišana telesna temperatura, pomisliti na možnost reakcije na zdravljenje z lamotriginom.
Table 5: Adults aged 18 years and above - adjustment of lamotrigine daily dosing following the addition of other medicinal products in treatment of bipolar disorder There is no clinical experience in adjusting the lamotrigine daily dose following the addition of other medicinal products.
Preglednica 5: Odrasli od 18. leta naprej - prilagoditev dnevnega odmerjanja lamotrigina po dodatku drugih zdravil pri zdravljenju bipolarne motnje
Withdrawal of inducers of lamotrigine glucuronidation (see section 4.5), depending on original dose of lamotrigine:
Ukinitev induktorjev glukuronidacije lamotrigina (glejte poglavje 4.5), odvisno od prvotnega odmerka 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).
Koncentracija lamotrigina je bila na koncu tedna neaktivnega zdravljenja v povprečju približno dvakrat večja kot med sočasno uporabo s kombinirano kontracepcijsko tableto (glejte poglavje 4.4).
• itchy eyes, with discharge and crusty eyelids (conjunctivitis)
• srbenje oči z izcedkom in krastami na vekah (konjunktivitis)
Skin and subcutaneous tissue disorders During bipolar disorder clinical trials: Very common:
Bolezni kože in podkožja Klinična preskušanja pri bipolarni motnji: Zelo pogosti:
25, 50, 100 and 200 mg tablets: Lactose monohydrate Microcrystalline cellulose Povidone K30
25-, 50-, 100- in 200 mg tablete: laktoza monohidrat mikrokristalna celuloza povidon K30 natrijev karboksimetilškrob (vrsta A) rumeni železov oksid (E172) magnezijev stearat
Lamictal 200 mg tablets are marked ‘GSEE7' on one side and ‘200' on the other.
Tablete Lamictal 200 mg imajo na eni strani oznako 'GSEE7' in na drugi strani '200'.
Excipient: Each tablet contains 109.0 mg lactose.
Pomožna snov: Ena tableta vsebuje 109,0 mg laktoze.
Monotherapy of typical absence seizures:
Monoterapija tipičnih absenc:
This dosage regimen should be used when other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation are added
Ta režim odmerjanja morate uporabiti, kadar dodate druga zdravila, ki pomembno ne zavirajo niti ne inducirajo glukuronidacije lamotrigina
Excipient: Each tablet contains 93.9 mg lactose.
Pomožna snov: Ena tableta vsebuje 93,9 mg laktoze.
Initial, escalation and maintenance doses should generally be reduced in patients with moderate or severe hepatic impairment (see section 4.2).
Na splošno je treba pri bolnikih z zmerno ali hudo okvaro jeter začetne odmerke, zviševanje odmerkov in vzdrževalne odmerke zmanjšati (glejte poglavje 4.2)
50 mg/day (once a day)
50 mg/dan (enkrat na dan)
They are marked ‘GSCL5' on one side; and ‘25' on the other.
Na eni strani imajo oznako ‘GSCL5', na drugi strani pa oznako ‘25'.
Dispersible/chewable tablets:
Disperzibilne/žvečljive tablete:
PVC/aluminium foil blister.
Pretisni omot iz PVC/aluminijske folije.
The active substance is lamotrigine.
Zdravilna učinkovina je lamotrigin.
Lamictal tablets should be swallowed whole, and should not be chewed or crushed.
4.2 Odmerjanje in način uporabe Tablete Lamictal mora bolnik zaužiti cele in jih ne sme žvečiti ali zdrobiti.
150 mg/day
150 mg/dan
They are marked ‘GSCX7' on one side; and ‘50' on the other.
Na eni strani imajo oznako ‘GSCX7', na drugi strani pa oznako ‘50'.
Occasionally, people with epilepsy may also have thoughts of harming themselves or committing suicide.
Občasno se lahko razmišljanje o samopoškodovanju ali o samomoru pojavi tudi pri bolnikih z epilepsijo.
If you have distressing thoughts or experiences, or if you notice that you feel worse or develop new symptoms while you're taking Lamictal:
Če se vam med jemanjem zdravila Lamictal pojavijo takšne misli ali ravnanje, ali če opazite poslabšanje počutja ali se vam pojavijo novi simptomi: Î se nemudoma posvetujte s svojim zdravnikom ali poiščite pomoč v najbližji bolnišnici.
Epidemiological studies involving in total approximately 2000 women exposed to lamotrigine monotherapy during pregnancy cannot exclude an increased risk for congenital malformations.
V epidemiološke študije je bilo vključenih približno 2000 žensk, ki so med nosečnostjo prejemale monoterapijo z lamotriginom.
Starter pack 21 dispersible/chewable tablets, valproate add-on therapy Starter pack 42 dispersible/chewable tablets, monotherapy
Začetno pakiranje z 21 disperzibilnimi/žvečljivimi tabletami, dodatek zdravljenja z valproatom Začetno pakiranje z 42 disperzibilnimi/žvečljivimi tabletami, monoterapija
Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation - see section 4.5): This dosage regimen should be used with valproate regardless of any other concomitant medicinal products
Dodatno zdravljenje Z VALPROATOM (zaviralec glukuronidacije lamotrigina - glejte poglavje 4.5): Ta režim odmerjanja morate uporabiti z valproatom ne glede na morebitna druga sočasna zdravila
If you notice any of these symptoms:
Če kaj od tega velja za vas:
Addition of valproate (inhibitor of lamotrigine glucuronidation - see section 4.5), depending on original dose of lamotrigine:
Dodatek valproata (zaviralec glukuronidacije lamotrigina - glejte poglavje 4.5), odvisno od prvotnega odmerka lamotrigina:
If your seizures happen more often, or if you experience a severe seizure while you're taking Lamictal:
Če se vam med zdravljenjem z zdravilom Lamictal napadi pojavljajo pogosteje kot ponavadi, ali če se pojavi hud napad:
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.
Don't stop taking Lamictal without advice Take Lamictal for as long as your doctor recommends.
Ne nehajte jemati zdravila Lamictal, ne da bi vam to naročil zdravnik.
Starter pack of 42 dispersible/chewable tablets.
Začetno pakiranje z 42 disperzibilnimi/žvečljivimi tabletami.
To achieve maintenance, doses may be increased by maximum of 25 - 50 mg every one to two weeks until optimal response is achieved
Za dosego vzdrževalnega odmerka, zvišujte odmerke za največ 25-50 mg na en do dva tedna, dokler ni dosežen optimalen odziv.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients who experience clinical worsening (including development of new symptoms) and/or the emergence of suicidal ideation/behaviour, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Pri bolnikih, ki se jim pojavijo klinično poslabšanje (vključno s pojavom novih simptomov) in/ali samomorilno razmišljanje/vedenje, pride v poštev sprememba terapevtskega režima, tudi z možnostjo prenehanja uporabe zdravila.
To achieve maintenance, doses may be increased by maximum of 1.2 mg/kg every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 400 mg/day
Za dosego vzdrževalnega odmerka, zvišujte odmerke za največ 1,2 mg/kg/dan na en do dva tedna, dokler ni dosežen optimalen odziv; največji vzdrževalni odmerek ne sme preseči 400 mg/dan..
Adjunctive therapy WITH valproate (inhibitor of lamotrigine glucuronidation - see section 4.5): This dosage regimen should be used with valproate regardless of any concomitant medicinal products
Dodatno zdravljenje Z VALPROATOM (zaviralec glukuronidacije lamotrigina - glejte poglavje 4.5): Ta režim odmerjanja morate uporabiti z valproatom ne glede na morebitna sočasna zdravila
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.
Opisano je, da lahko lamotrigin poslabša parkinsonske simptome pri bolnikih, ki že imajo Parkinsonovo bolezen.
Lamotrigine caused a dose-related inhibition of the hERG channel tail current in human embryonic kidney cells.
V človeških embrionalnih ledvičnih celicah je lamotrigin povzročil, od odmerka odvisno inhibicijo terminalnega toka hERG kanalov.
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.
Študija SCAB2003 je bila multicentrična, randomizirana dvojno slepa raziskava stalnega odmerka z vzporednim placebom, kontrolirana s placebom in litijem.
Excipient: Each tablet contains 23.5 mg lactose.
Pomožna snov: 23,5 mg laktoze.
headache.
glavobol.
If such signs and symptoms are present, the patient should be evaluated immediately and Lamictal discontinued if an alternative aetiology cannot be established.
Če se pojavijo takšni znaki in simptomi, je treba bolnika takoj pregledati.
This dosage regimen should be used without valproate but with:
Ta režim odmerjanja morate uporabiti, kadar bolnik ne jemlje valproata, prejema pa:
25 mg tablets:
25 mg tablete:
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.
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).
Each pack contains blisters of 30, 56 or 100 tablets.
Eno pakiranje vsebuje pretisne omote s 30, 56 ali 100 tabletami.
Belgium GlaxoSmithKline s.a. Rue du Tilleul 13, B86
GlaxoSmithKline s.a. Rue du Tilleul 13, B86 1332 Genval Belgija
Following titration, higher maintenance doses of lamotrigine (by as much as two-fold) may be needed to attain a maximal therapeutic response.
Za največji terapevtski odziv so lahko po titriranju potrebni višji (celo dvakratni) vzdrževalni odmerki lamotrigina.
• feeling sick (nausea) or being sick (vomiting)
• slabost v želodcu (navzeja) ali bruhanje
This dosage regimen should be used with other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation
Ta režim odmerjanja morate uporabiti z zdravili, ki pomembno ne zavirajo niti ne inducirajo glukuronidacije lamotrigina
Starter pack 42 tablets, non-valproate add-on therapy
Začetno pakiranje z 42 tabletami, dodatek zdravljenja brez valproata
Following the co-administration of risperidone 2 mg with lamotrigine, 12 out of the 14 volunteers reported somnolence compared to 1 out of 20 when risperidone was given alone, and none when lamotrigine was administered alone.
Ko je bil risperidon uporabljen sam, je bil ta delež 1 od 20, ko pa je bil lamotrigin uporabljen sam, pa nič.
Addition of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
Dodatek zdravil, ki pomembno ne zavirajo NITI ne inducirajo glukuronidacije lamotrigina (glejte poglavje 4.5):
Withdrawal of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
Ukinitev zdravil, ki pomembno ne zavirajo NITI ne inducirajo glukuronidacije lamotrigina NITI (glejte poglavje 4.5):
Lamictal 25 mg tablets are marked ‘GSEC7' on one side and ‘25' on the other.
Tablete Lamictal 25 mg imajo na eni strani oznako 'GSEC7' in na drugi strani '25'.
200 − 400 mg/day (two divided doses)
200 - 400 mg/dan (v dveh deljenih odmerkih)
Withdrawal of valproate (inhibitor of lamotrigine glucuronidation - see section 4.5), depending on original dose of lamotrigine:
Ukinitev valproata (zaviralec glukuronidacije lamotrigina - glejte poglavje 4.5), odvisno od prvotnega odmerka lamotrigina:
Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation (see section 4.5):
Dodatno zdravljenje BREZ VALPROATA IN Z INDUKTORJI glukuronidacije lamotrigina (glejte poglavje 4.5):
Suicidal ideation and behaviours (suicidality) have been reported in patients treated with AEDs in several indications, including epilepsy and bipolar disorder.
Pri bolnikih, ki so bili zaradi različnih indikacij zdravljeni z antiepileptičnimi zdravili, vključno z epilepsijo in bipolarno motnjo, sta opisana samomorilno razmišljanje in vedenje (samomorilnost).
To achieve maintenance, doses may be increased by maximum of 0.6 mg/kg every one to two weeks until optimal response is achieved, with a maximum of maintenance dose of 200 mg/day
Za dosego vzdrževalnega odmerka, zvišujte odmerke za največ 0,6 mg/kg/dan na en do dva tedna, dokler ni dosežen optimalen odziv; največji vzdrževalni odmerek ne sme preseči 200 mg/dan..
Marketing Authorisation Holder
Imetnik dovoljenja za promet Izmišljeno ime
White to off-white, elongated, biconvex tablet with a blackcurrant odour, marked “GS CL2” on one side and “5” on the other.
Bele do umazano bele, podolgovate, bikonveksna tablete z vonjem po črnem ribezu, označene z "GS CL2" na eni strani in "5" na drugi.
Lamictal 100 mg tablets are marked ‘GSEE5' on one side and ‘100' on the other.
Tablete Lamictal 100 mg imajo na eni strani oznako 'GSEE5' in na drugi strani '100'.
METHOD AND ROUTE OF ADMINISTRATION Oral use
POSTOPEK IN POT(I) UPORABE ZDRAVILA Peroralna uporaba
If any of these applies to you: Î Tell your doctor, who may decide to lower your dose, or that Lamictal is not suitable for you.
Î Povejte svojemu zdravniku; morda vam bo zmanjšal odmerek, ali bo presodil, da zdravilo Lamictal za vas ni primerno.
Marketing Authorisation Holder: [See Annex I - To be completed nationally]
Imetnik dovoljenja za promet: [Glejte Dodatek I - Izpolni država članica]
“Children 2 to 12 years {Tradename} is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome”.
Zdravilo {trgovsko ime zdravila} je indicirano kot dopolnilno zdravljenje pri zdravljenju epilepsije, pri delnih napadih in generaliziranih napadih, vključno s tonično-kloničnimi napadi in napadi, povezanimi z Lennox-Gastautovim sindromom“.
In patients receiving concomitant therapy with valproate, the appropriate treatment regimen should be used (see section 4.2).
Za bolnike, ki se sočasno zdravijo z valproatom, morate uporabiti ustrezen režim zdravljenja (glejte poglavje 4.2).
Lamictal 50 mg tablets are marked ‘GSEE1' on one side and ‘50' on the other.
Tablete Lamictal 50 mg imajo na eni strani oznako 'GSEE1' in na drugi strani '50'.
Each pack contains blisters of 10, 14, 28, 30, 50 or 56 tablets.
Eno pakiranje vsebuje pretisne omote z 10, 14, 28, 30, 50 ali 56 tabletami.
“Adults and children above 12 years {Tradename} is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome”.
Zdravilo {trgovsko ime zdravila} je indicirano kot dopolnilno zdravljenje ali monoterapija pri zdravljenju epilepsije, pri delnih napadih in generaliziranih napadih, vključno s tonično-kloničnimi napadi in napadi, povezanimi z Lennox-Gastautovim sindromom“.
• shaking or tremors
• grobo ali drobno tresenje
Each Lamictal 200 mg tablet contains 200 mg lamotrigine.
Ena tableta Lamictal 200 mg vsebuje 200 mg lamotrigina.
ataxia.
ataksija.
• lithium, used to treat mental health problems
• litij, ki se uporablja za zdravljenje težav z duševnim zdravjem,
Lamictal Dispersible 50mg Starter-Pack add-on 50 mg Dispersible Tablet
Lamictal Dispersible 50mg Starter-Pack add-on 50 mg Disperzibilna tableta Peroralna uporaba
Major manic episode Lamotrigine Lithium Placebo Lamotrigine Lithium Placebo
Placebo Lamotrigin Litij
Starter pack 42 dispersible/chewable tablets, non-valproate add-on therapy
Začetno pakiranje z 42 disperzibilnimi/žvečljivimi tabletami, dodatek zdravljenja brez valproata
200 mg tablets:
200 mg tablete:
Musculoskeletal and connective tissue disorders During bipolar disorder clinical trials: Common:
Bolezni mišično-skeletnega sistema in vezivnega tkiva Klinična preskušanja pri bipolarni motnji: Pogosti:
400 mg/day 300 mg/day 200 mg/day
400 mg/dan 300 mg/dan 200 mg/dan
42 dispersible/chewable tablets
42 disperzibilnih/žvečljivih tablet
50 mg tablets:
50 mg tablete:
Packs of 14, 21, 30, 42, 50, 56 or 100 tablets.
Pakiranja s 14, 21, 30, 42, 50, 56 ali 100 tabletami.
150 mg/day 225 mg/day 300 mg/day
150 mg/dan 225 mg/dan 300 mg/dan
5 − 15 mg/kg/day (once a day or two divided doses)
5 - 15 mg/kg/dan (enkrat na dan ali v dveh deljenih odmerkih)
Each Lamictal 100 mg tablet contains 100 mg lamotrigine.
Ena tableta Lamictal 100 mg vsebuje 100 mg lamotrigina.
200 mg/day 300 mg/day 400 mg/day
200 mg/dan 300 mg/dan 400 mg/dan
• your age
• vaše starosti,
The need for treatment with AEDs should be reviewed when a woman is planning to become pregnant.
Če ženska načrtuje nosečnost, je treba znova pretehtati potrebo po zdravljenju z antiepileptiki.
To achieve maintenance, doses may be increased by maximum of 100 mg every one to two weeks until optimal response is achieved
Za dosego vzdrževalnega odmerka, zvišujte odmerke za največ 100 mg na en do dva tedna, dokler ni dosežen optimalen odziv.
100 mg tablets:
100 mg tablete:
GROUNDS FOR AMENDMENT OF THE SUMMARYIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
Each Lamictal 25 mg tablet contains 25 mg lamotrigine.
Ena tableta Lamictal 25 mg vsebuje 25 mg lamotrigina.
Maintain target dose achieved in dose escalation (200 mg/day; two divided doses) (dose range 100 - 400 mg/day)
Vzdržujte ciljni odmerek, dosežen pri zviševanju odmerka (200 mg/dan; dva deljena odmerka).
Adjunctive therapy WITHOUT valproate and WITHOUT inducers of lamotrigine glucuronidation (see section 4.5):
Dodatno zdravljenje BREZ VALPROATA IN BREZ INDUKTORJEV glukuronidacije lamotrigina (glejte poglavje 4.5):
300 mg/day 225 mg/day 150 mg/day
300 mg/dan 225 mg/dan 150 mg/dan
Packs of 10, 14, 28, 30, 50 or 56 dispersible/chewable tablets.
Pakiranja z 10, 14, 28, 30, 50 ali 56 disperzibilnimi/žvečljivimi tabletami.
50 mg/day (once a day or two divided doses)
50 mg/dan (enkrat na dan ali v dveh deljenih odmerkih)