FrancophonIA/ELRC3.0 huggingface dataset:
English: You can take Lamictal dispersible/chewable tablets by swallowing them whole with a little water, by chewing them, or by dissolving them in water:
Danish: Du kan tage Lamictal dispergible tabletter / tyggetabletter ved at synke dem hele med lidt vand, tygge dem eller opløse dem i vand.
English: Glaxo Wellcome Operations Greenford Road Greenford
Danish: Estland Glaxo Wellcome Operations Greenford Road
English: The syndrome shows a wide spectrum of clinical severity and may, rarely, lead to disseminated intravascular coagulation and multiorgan failure.
Danish: Syndromet optræder i et bredt spektrum af kliniske sværhedsgrader og kan i sjældne tilfælde føre til dissemineret intravaskulær koagulation og multiorgansvigt.
English: • a sore mouth or eyes
Danish: • Ømhed i mund eller øjne
English: These may be signs that Lamictal is affecting the way your contraceptive is working.
Danish: Dette kan være tegn på, at Lamictal påvirker effekten af det svangerskabsforebyggende middel.
English: Never take more Lamictal than your doctor tells you to.
Danish: Tag aldrig mere Lamictal, end lægen har foreskrevet.
English: It is indicated as monotherapy as well as adjuvant therapy in partial seizures with or without secondary generalisation, primary generalised seizures and some specific seizure types.
Danish: Lægemidlet er indiceret som monoterapi og som tillægsbehandling af partielle anfald med eller uden sekundær generalisering, primære generaliserede anfald og visse specifikke anfaldstyper.
English: • a combination of lopinavir and ritonavir, used to treat Human Immunodeficiency Virus
Danish: • En kombination af lopinavir og ritonavir, der anvendes til behandling af infektion med humant immundefektvirus (HIV)
English: 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).
Danish: Virkningen af den beskedne stigning i levonorgestrels clearance samt ændringerne i FSH og LH i serum på ovariets ovulatoriske aktivitet kendes ikke (se pkt.
English: • oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy
Danish: • Oxcarbazepin, felbamat, gabapentin, levetiracetam, pregabalin, topiramat eller zonisamid, der anvendes til behandling af epilepsi
English: Precautions relating to epilepsy
Danish: Forsigtighedsregler i forbindelse med epilepsi
English: These experiments also suggested that metabolism of lamotrigine was unlikely to be inhibited by clozapine, fluoxetine, phenelzine, risperidone, sertraline or trazodone.
Danish: Disse forsøg tydede også på, at metaboliseringen af lamotrigin sandsynligvis ikke hæmmes af clozapin, fluoxetin, phenelzin, risperidon, sertralin eller trazodon.
English: Valproate, which inhibits the glucuronidation of lamotrigine, reduces the metabolism of lamotrigine and increases the mean half-life of lamotrigine nearly two-fold.
Danish: Valproat, der hæmmer glukuronideringen af lamotrigin, reducerer metaboliseringen af lamotrigin og øger den gennemsnitlige halveringstid af lamotrigin til næsten det dobbelte.
English: When all bipolar disorder studies (controlled and uncontrolled) conducted with lamotrigine are considered, skin rashes occurred in 12% of patients on lamotrigine.
Danish: Når der tages højde for alle de forsøg med bipolar sygdom (kontrollerede og ukontrollerede), der er udført med lamotrigin, forekom der hududslæt hos 12 % af de patienter, som fik lamotrigin.
English: Lennox-Gastaut Syndrome is a difficult to treat condition and monotherapy is rarely achieved.
Danish: Lennox-Gastaut syndrom er vanskelig at behandle, og monoterapi er sjældent mulig.
English: No dosage adjustment from the recommended schedule is required.
Danish: Dosisjustering i forhold til den anbefalede doseringsplan er ikke nødvendig.
English: Weeks 1 + 2 Weeks 3 + 4 Usual maintenance dose
Danish: Uge 3 + 4 Normal vedligeholdelsesdosis
English: 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.
Danish: Efter samtidig administration af 2 mg risperidon og lamotrigin rapporterede 12 ud af de 14 frivillige somnolens sammenlignet med 1 ud af 20, når risperidon blev administreret alene, og ingen, når lamotrigin blev administreret alene.
English: People with bipolar disorder can sometimes have thoughts of harming themselves or committing suicide.
Danish: Patienter med bipolar sygdom kan sommetider have tanker om at skade sig selv eller begå selvmord.
English: 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.
Danish: Forsøg in vitro tydede på, at dannelsen af lamotrigins primære metabolit, 2-N-glukuronid, blev hæmmet minimalt ved samtidig inkubation med amitriptylin, bupropion, clonazepam, haloperidol eller lorazepam.
English: The mean half-life was estimated at 23 hours in infants younger than 26 months on enzyme-inducing therapy, 136 hours when co-administered with valproate and 38 hours in subjects treated without enzyme inducers/inhibitors.
Danish: Den gennemsnitlige halveringstid blev vurderet til at være 23 timer hos spædbørn under 26 måneder, som var i enzyminducerende behandling, 136 timer ved administration sammen med valproat og 38 timer hos forsøgspersoner, der blev behandlet uden enzyminduktorer/-hæmmere.
English: These data indicate that lamotrigine does not influence the pharmacokinetics of levetiracetam and that levetiracetam does not influence the pharmacokinetics of lamotrigine.
Danish: Disse data tyder på, at lamotrigin ikke påvirker levetiracetams farmakokinetik, og at levetiracetam ikke påvirker lamotrigins farmakokinetik.
English: 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.
Danish: CHMP var af den opfattelse, at lamotrigin er effektivt til forebyggelse af ét aspekt ved humørsvingningerne ved bipolar lidelse, nemlig de depressive episoder, mens evnen til forebyggelse af maniske eller hypomaniske episoder ikke er blevet påvist.
English: Therapy with multiple AEDs is associated with a higher risk of congenital malformations than monotherapy and therefore monotherapy should be used whenever possible.
Danish: Behandling med flere antiepileptika er forbundet med en højere risiko for medfødte misdannelser end monoterapi, og derfor skal monoterapi altid benyttes, når det er muligt.
English: Dihydrofolate reductase
Danish: Dihydrofolatreduktase
English: • aggression or irritability
Danish: • Aggressivitet eller irritabilitet
English: Lamictal tablets contain lactose monohydrate.
Danish: Lamictal-tabletter indeholder lactosemonohydrat.
English: Steady-state trough plasma concentrations of lamotrigine were not affected by concomitant pregabalin (200 mg, 3 times daily) administration.
Danish: De laveste plasmakoncentrationer af lamotrigin ved steady state blev ikke påvirket af samtidig administration af pregabalin (200 mg tre gange dagligt).
English: The group concurred that theoretically a mood stabiliser should be able to prevent both manic and depressive recurrences, the characteristic features of Bipolar Disorder, but as of now we do not possess such an ideal mood stabiliser.
Danish: Gruppen var enig om, at en humørstabilisator teoretisk set bør være i stand til at forebygge både de maniske og de depressive tilbagefald, som er karakteristiske for bipolar lidelse, men for øjeblikket findes der ikke en sådan ideel humørstabilisator.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt {MM/ÅÅÅÅ} [Udfyldes nationalt]
English: Overdose has resulted in symptoms including nystagmus, ataxia, impaired consciousness and coma.
Danish: Overdosering har medført symptomer, som omfatter nystagmus, ataksi, bevidsthedssvækkelse og koma.
English: The indication will specify that the target population is “Adults and adolescents aged 13 years and above”.
Danish: I indikationen vil den angivne målpopulation være “Voksne og unge på 13 år og derover”.
English: hepatic failure, hepatic dysfunction, increased liver function tests.
Danish: Leversvigt, hepatisk dysfunktion, forhøjede værdier ved leverfunktionsundersøgelser.
English: Patients taking other preparations containing lamotrigine
Danish: Patienter, som tager andre præparater med lamotrigin
English: Unless safety concerns (for example rash) require an abrupt withdrawal, the dose of Lamictal should be gradually decreased over a period of two weeks.
Danish: Medmindre der kræves øjeblikkelig seponering af sikkerhedsmæssige årsager (f.eks. udslæt), skal dosis af Lamictal reduceres gradvist over en periode på to uger.
English: Lamotrigine caused a dose-related inhibition of the hERG channel tail current in human embryonic kidney cells.
Danish: Lamotrigin medførte en dosisrelateret hæmning af hERG-kanalens tilbageløbsstrøm i humane embryoniske nyreceller.
English: Lamictal also treats bipolar disorder.
Danish: Lamictal virker også mod bipolar sygdom.
English: Your doctor may advise you to take extra folic acid if you're planning to become pregnant and while you're pregnant.
Danish: Lægen kan anbefale, at du tager ekstra folsyre, hvis du planlægger at blive gravid samt under graviditeten.
English: In some breast-fed infants, the serum concentrations of lamotrigine reached levels at which pharmacological effects may occur.
Danish: Serumkoncentrationen af lamotrigin nåede hos nogle ammede spædbørn op på niveauer, ved hvilke der kan forekomme farmakologiske effekter.
English: The pharmacokinetics of lamotrigine in this age group do not differ significantly from a non-elderly adult population (see section 5.2).
Danish: Lamotrigins farmakokinetik hos denne aldersgruppe adskiller sig ikke væsentligt fra den, der ses hos en yngre voksen population (se pkt.
English: Table 6: Effects of other medicinal products on glucuronidation of lamotrigine
Danish: Tabel 6: Effekten af andre lægemidler på glukuronidering af lamotrigin
English: Treatment Regimen
Danish: Behandlingsregimen
English: 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.
Danish: Forsøg SCAB2003 var en randomiseret, dobbeltblindet, placebo- og lithiumkontrolleret multicentervurdering med double dummy og faste doser af langtidsforebyggelsen af recidiv og tilbagefald af depression og/eller mani hos patienter med bipolar affektiv sindslidelse af type I, der for nylig havde haft eller aktuelt havde en svær depressiv episode.
English: Do not pass it on to others.
Danish: Lad derfor være med at give Lamictal til andre.
English: In the subset of epilepsy trials, there were no statistically significant differences in the rate of events between lamotrigine and placebo.
Danish: I forsøg for epilepsi var der ingen statistisk signifikant forskel i mængden af hændelser mellem lamotrigin og placebo.
English: If you stop taking Lamictal, your dose will not need to be reduced gradually.
Danish: Hvis du holder op med at tage Lamictal, er det ikke nødvendigt at nedsætte dosis gradvist.
English: Topiramate resulted in no change in plasma concentrations of lamotrigine.
Danish: Topiramat medførte ingen ændringer i plasmakoncentrationen af lamotrigin.
English: • a disorder of blood clotting, which can cause unexpected bleeding or bruising (disseminated intravascular coagulation)
Danish: • Problemer med blodets størkningsevne, hvilket kan give uventede blødninger eller blå mærker (dissemineret intravaskulær koagulation)
English: Clinical efficacy and safety in Lennox-Gastaut syndrome
Danish: Klinisk effekt og sikkerhed ved Lennox-Gastaut-syndrom
English: If your seizures happen more often, or if you experience a severe seizure while you're taking Lamictal:
Danish: Hvis du oftere får anfald, eller hvis du oplever et svært anfald, mens du tager Lamictal:
English: 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.
Danish: CHMP konkluderede i betragtning af vurderingen af undersøgelserne og anbefalingerne fra den videnskabelige rådgivende gruppe, at lamotrigin bør anvendes til forebyggelse af depressive episoder hos patienter med bipolar I-lidelse, som overvejende oplever depressive episoder.
English: There was no clinically significant effect of lamotrigine on QT interval compared to placebo.
Danish: Lamotrigin havde ingen klinisk signifikant effekt på QT-intervallet sammenlignet med placebo.
English: GlaxoSmithKline Latvia SIA Bruninieku iela 5
Danish: Letland GlaxoSmithKline Letland SIA Bruninieku iela 5
English: The decrease after 48 weeks of treatment was 10% from 41 to 37 mL/min between the young and elderly groups.
Danish: Efter 48 ugers behandling var clearance faldet med 10 % fra 41 til 37 ml/min.
English: 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.
Danish: Der blev hos rotter observeret øget føtal og postnatal mortalitet ved administration af lamotrigin sent i drægtighedsperioden og tidligt i den postnatale periode.
English: Folic acid deficiency is assumed to be associated with an enhanced risk of congenital malformations in animals as well as in humans.
Danish: Folsyremangel antages at være forbundet med en øget risiko for medfødte misdannelser hos både dyr og mennesker.
English: If you are taking certain medicines, your doctor may need to check the dose of Lamictal.
Danish: Hvis du tager noget bestemt slags medicin, kan det være nødvendigt for lægen at kontrollere dosis af Lamictal.
English: 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.
Danish: Der blev observeret en beskeden stigning i den perorale clearance af levonorgestrel-komponenten, hvilket medførte et gennemsnitligt fald i AUC og Cmax af levonorgestrel på henholdsvis 19 % og 12 %.
English: 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.
Danish: Eftersom der er individuelle forskelle i responsen på enhver behandling med antiepileptika, skal patienter, som tager Lamictal til behandling af epilepsi, konsultere en læge vedrørende epilepsi og evnen til at føre motorkøretøj.
English: 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.
Danish: Forsøg SCAB2006 havde samme design som forsøg SCAB2003, men adskilte sig fra forsøg SCAB2003 ved, at der blev vurderet en fleksibel dosis lamotrigin (100 til 400 mg/dag) og ved, at det omfattede patienter med bipolar affektiv sindslidelse af type I, som for nylig havde haft eller aktuelt havde en manisk episode.
English: There are limited data on the efficacy and safety of lamotrigine for adjunctive therapy of partial seizures in children aged 1 month to 2 years (see section 4.4).
Danish: Der er begrænsede data på lamotrigins effekt og sikkerhed for tillægsbehandling af partielle anfald hos børn i alderen 1 måned til 2 år (se pkt.
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).
Danish: Overgangsregimenet omfatter en gradvis øgning af lamotrigindosis til en vedligeholdende stabiliseringsdosis i løbet af seks uger (tabel 3), hvorefter behandling med andre psykofarmaka og/eller antiepileptika kan seponeres, hvis der er klinisk indikation herfor (tabel 4).
English: Escalation and maintenance doses should be adjusted according to clinical response (see section 5.2).
Danish: Øgnings- og vedligeholdelsesdosis skal justeres i forhold til den kliniske respons (se pkt.
English: During other clinical experience: Very common:
Danish: Ved anden klinisk erfaring: Meget almindelig:
English: The undesirable effects have been divided into epilepsy and bipolar specific sections based on the data currently available.
Danish: Bivirkningerne er inddelt i et afsnit om epilepsi og et afsnit om bipolar sygdom på basis af de aktuelt foreliggende data.
English: Denmark GlaxoSmithKline Pharma A/S Nykaer 68
Danish: Danmark GlaxoSmithKline Pharma A/S Nykaer 68
English: Hence an article 30 procedure (Directive 2001/83/EC) for harmonisation of the SPC of lamotrigine across Europe has been initiated by the Marketing Authorisation Holder.
Danish: Indehaverne af markedsføringstilladelsen har derfor indledt en artikel 30-procedure (i henhold til Rådets direktiv 2001/83/EØF) med henblik på harmonisering af produktresuméerne for lamotrigin i hele Europa.
English: Risk related to lamotrigine
Danish: Risici i forbindelse med lamotrigin
English: They are marked ‘LTG' above the number ‘2' on one side; and with two ovals overlapping at right angles on the other.
Danish: De er påtrykt 'LTG' over tallet '2' på den ene side, og den anden side har to overlappende ovale figurer, der ligger vinkelret på hinanden.
English: A meta-analysis of placebo-controlled trials of AEDs (including lamotrigine) showed an increased risk of suicidal behaviour (see section 5.1).
Danish: En meta-analyse af placebokontrolleret forsøg af antiepileptika (herunder lamotrigin) viste en forhøjet risiko for selvmordsadfærd (se pkt.
English: Lamotrigine at 200 mg did not affect the pharmacokinetics of olanzapine.
Danish: 200 mg lamotrigin påvirkede ikke olanzapins farmakokinetik.
English: Certain patients, such as those with a history of suicidal behaviour or thoughts, young adults, and those patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment, may be at a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Danish: Enkelte patienter, f.eks. patienter med selvmordsadfærd eller -tanker i anamnesen, unge voksne og patienter, som før behandlingen har haft selvmordstanker i væsentligt omfang, synes at have øget risiko for selvmordstanker eller selvmordsforsøg.
English: Data indicate that lamotrigine passes into breast milk.
Danish: Data tyder på, at lamotrigin udskilles i modermælk.
English: HDPE bottles with a child resistant/tamper evident closure.
Danish: HDPE-glas med børnesikret/åbningssikret lukning.
English: If you are using a hormonal contraceptive, and you notice any changes in your menstrual pattern, such as breakthrough bleeding or spotting between periods: Î Tell your doctor.
Danish: Hvis du bruger et hormonalt svangerskabsforebyggende middel, og du bemærker ændringer i dit menstruationsmønster, f.eks. gennembrudsblødning eller pletblødning mellem menstruationerne:
English: Pregnancy may also alter the effectiveness of Lamictal, so your doctor may take samples of your blood to check the level of Lamictal, and may adjust your dose.
Danish: Graviditet kan også ændre Lamictals effekt, og lægen kan derfor tage blodprøver for at kontrollere niveauet af Lamictal i dit blod.
English: Suicidal ideation and behaviours (suicidality) have been reported in patients treated with AEDs in several indications, including epilepsy and bipolar disorder.
Danish: Forekomst af selvmordstanker og -adfærd (suicidalitet) er blevet set hos patienter i behandling med antiepileptika for flere indikationer, herunder epilepsi og bipolar sygdom.
English: In a study of subjects with Gilbert's Syndrome, mean apparent clearance was reduced by 32% compared with normal controls but the values are within the range for the general population.
Danish: I et forsøg hos forsøgspersoner med Gilbert-Meulengrachts sygdom blev den påviselige gennemsnitlige clearance reduceret med 32 % i forhold til den raske kontrolgruppe, men værdierne ligger inden for det område, der gælder for den almene befolkning.
English: • a high temperature (fever), flu-like symptoms or drowsiness
Danish: • Høj legemstemperatur (feber), influenzalignende symptomer eller døsighed
English: 30 tablets 50 tablets 56 tablets 60 tablets 90 tablets 100 tablets
Danish: 30 tabletter 50 tabletter 56 tabletter 60 tabletter 90 tabletter 100 tabletter
English: Mean plasma half-lives were 42.9 hours (chronic renal failure), 57.4 hours (between hemodialysis) and 13.0 hours (during hemodialysis), compared with 26.2 hours in healthy volunteers.
Danish: De gennemsnitlige plasmahalveringstider var 42,9 timer (kronisk nedsat nyrefunktion), 57,4 timer (mellem hæmodialyser) og 13,0 timer (under hæmodialyse) i forhold til 26,2 timer hos raske frivillige.
English: 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.
Danish: Det er i litteraturen beskrevet, at svære krampeanfald, herunder status epilepticus, kan føre til rabdomyolyse, dysfunktion af flere organer og dissemineret intravaskulær koagulation, undertiden med fatalt udfald.
English: One registry has reported an increased incidence of facial clefts.
Danish: Der er i ét register rapporteret om en øget incidens af kindspalte.
English: 500 mg/day has been required by some patients to achieve desired response
Danish: Nogle patienter har haft behov for 500 mg/dag for at opnå den ønskede respons
English: Î Talk to your doctor if you're breast feeding or planning to breast feed.
Danish: Î Tal med lægen, hvis du ammer eller planlægger at amme.
English: Î Tell your doctor, and don't take Lamictal.
Danish: Î Tal med lægen, og lad være med at tage Lamictal.
English: As the efficacy has been demonstrated for prevention of recurrence only, lamotrigine is not indicated for the acute treatment of manic or depressive episodes.
Danish: Da der kun er påvist virkning mod forebyggelse af tilbagefald, er lamotrigin ikke indiceret til akut behandling af maniske eller depressive episoder.
English: If such signs and symptoms are present, the patient should be evaluated immediately and Lamictal discontinued if an alternative aetiology cannot be established.
Danish: Hvis sådanne tegn og symptomer opstår, skal patienten straks undersøges, og behandlingen med Lamictal skal seponeres, hvis der ikke kan etableres en alternativ ætiologi.
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.
Danish: Ved længerevarende behandling af mennesker har lamotrigin dog ikke induceret signifikante ændringer i hæmoglobinkoncentrationen, middelerytrocytvolumenet eller serum- eller erytrocytfolatkoncentrationen i op til ét år eller erytrocytfolatkoncentrationen i op til fem år.
English: 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).
Danish: CHMP anbefalede ændring af markedsføringstilladelsen/-erne for Lamictal og tilknyttede navne (se bilag I), for hvilke produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III.
English: White to off-white round tablet with a blackcurrant odour.
Danish: Hvid til offwhite, rund tablet med solbærlugt.
English: diarrhoea.
Danish: Diarré.