FrancophonIA/ELRC3.0 huggingface dataset:
English: One side has a bevelled edge and is marked “LTG” above the number 2.
Danish: Den ene side har en skrå kant og er påtrykt "LTG" over tallet 2.
English: • unexpected bleeding or bruising, or your fingers turning blue
Danish: • Uventede blødninger eller blå mærker eller fingrene bliver blå
English: Major depressive episode
Danish: Svær depressiv episode
English: There are no pharmacokinetic interactions between lamotrigine and pregabalin.
Danish: Der er ingen farmakokinetiske interaktioner mellem lamotrigin og pregabalin.
English: The primary endpoint was "Time to Intervention for a Mood Episode (TIME)", where the interventions were additional pharmacotherapy or electroconvulsive therapy (ECT).
Danish: Det primære endpoint var "tid til intervention i en stemningsepisode", hvor interventionerne var yderligere farmakoterapi eller elektrochokbehandling.
English: If therapy with Lamictal is considered necessary during pregnancy, the lowest possible therapeutic dose is recommended.
Danish: Hvis behandling med Lamictal under graviditet vurderes at være nødvendig, anbefales det at anvende den lavest mulige terapeutiske dosis.
English: Theresienhöhe 11
Danish: KG Theresienhöhe 11
English: • hormonal contraceptives, such as the Pill (see below).
Danish: • Hormonale svangerskabsforebyggende midler, f.eks. p-piller (se nedenfor).
English: Only about 2% of lamotrigine-related material is excreted in faeces.
Danish: Kun ca. 2 % af de lamotrigin-relaterede bestanddele udskilles i fæces.
English: Nevertheless differences exist with respect to the precise wording of the epilepsy indication, restriction of age-categories, seizure types, dose recommendations and interactions.
Danish: Dog forekommer der afvigelser med hensyn til den præcise formulering af epilepsiindikationen, afgrænsningen af alderskategorier, anfaldstyper, dosisanbefalinger og interaktioner.
English: • clumsiness and lack of co-ordination (ataxia)
Danish: • Klodsethed og manglende koordinationsevne (ataksi)
English: Also, the current standard treatments for Bipolar disorder and the feasibility of monotherapy were discussed.
Danish: Ligeledes blev de nuværende standardbehandlinger af bipolar lidelse og gennemførligheden af monoterapi drøftet.
English: Specifically, the SAG was asked to clarify the definition of a mood stabiliser and the need for a medicinal product to act on both poles of the disorders.
Danish: Specifikt blev den videnskabelige gruppe bedt om at præcisere definitionen af en humørstabilisator og behovet for et lægemiddel med virkning på begge poler.
English: If you have distressing thoughts or experiences, or if you notice that you feel worse or develop new symptoms while you're taking Lamictal:
Danish: Hvis du har foruroligende tanker eller oplevelser, eller hvis du bemærker, at du får det værre eller udvikler nye symptomer, mens du tager Lamictal:
English: Lithium Buproprion Olanzapine
Danish: Lithium Bupropion Olanzapin
English: Treatment is initiated as monotherapy, but almost inevitably soon other antiepileptics will be added to control the symptoms.
Danish: Behandlingen indledes som monoterapi, men snart vil der næsten uundgåeligt blive tilføjet andre antiepileptika for at kontrollere symptomerne.
English: Ethinyloestradiol/ levonorgestrel combination*
Danish: Kombination af ethinyløstradiol/levonorgestrel*
English: Lamotrigine did not cause QT prolongation in animals at exposures up to approximately two-times the maximum therapeutic free concentration.
Danish: Lamotrigin medførte ikke en QT-forlængelse hos dyr ved eksponeringer på op til ca. to gange den maksimale terapeutiske frie koncentration.
English: Pharmacotherapeutic group: other antiepileptics, ATC code: N03AX09.
Danish: Farmakoterapeutisk klassifikation: andre antiepileptika, ATC-kode: N03AX09.
English: The majority of rashes are mild and self-limiting, however serious rashes requiring hospitalisation and discontinuation of lamotrigine have also been reported.
Danish: Størstedelen af hududslættene er milde og selvbegrænsende, men der er også rapporteret om alvorlige udslæt, som krævede hospitalsindlæggelse og seponering af lamotrigin.
English: Thoughts of harming yourself or suicide
Danish: Tanker om at skade dig selv eller selvmord
English: The usual effective dose of Lamictal for adults and children aged over 12 years is between 100 mg and 400 mg each day.
Danish: Den sædvanlige effektive dosis Lamictal til voksne og børn over 12 år er mellem 100 mg og 400 mg om dagen.
English: It can be used on its own to treat a type of epilepsy called typical absence seizures.
Danish: Det kan anvendes alene til behandling af en form for epilepsi, der kaldes typisk absenceepilepsi.
English: A clinically significant worsening of seizure frequency instead of an improvement may be observed.
Danish: Der kan forekomme en klinisk signifikant forværring af anfaldshyppighed i stedet for en forbedring.
English: The target population will be Bipolar I patients, as these patients were included in the clinical studies.
Danish: Målpopulationen vil være bipolar I-patienter, da de kliniske undersøgelser omfattede disse patienter.
English: 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%]).
Danish: I forsøg for bipolar sygdom var mængden af hændelser numerisk, men ikke statistisk signifikant, større for lamotrigin (29/1212 [2,4 %]) sammenlignet med placebo (19/1054 [1,8 %]).
English: Clearance adjusted for body weight is higher in children than in adults with the highest values in children under five years.
Danish: Clearance justeret for legemsvægt er højere hos børn end hos voksne, og værdierne er højest hos børn under fem år.
English: toxic epidermal necrolysis.
Danish: Toksisk epidermal nekrolyse.
English: It may take a while to find the best dose of Lamictal for you.
Danish: Det kan tage et stykke tid at finde frem til den optimale dosis Lamictal.
English: Similar cases have occurred in association with the use of lamotrigine.
Danish: Der er forekommet lignende tilfælde i forbindelse med brug af lamotrigin.
English: Lamictal should not be given to people aged under 18 years to treat bipolar disorder.
Danish: Lamictal må ikke gives til personer under 18 år til behandling af bipolar sygdom.
English: • a high temperature (fever)
Danish: • Høj legemstemperatur (feber)
English: Lamotrigine is rapidly and completely absorbed from the gut with no significant first-pass metabolism.
Danish: Lamotrigin absorberes hurtigt og fuldstændigt fra tarmen uden signifikant first-pass-metabolisering.
English: Therefore, patients should see how Lamictal therapy affects them before driving or operating machinery.
Danish: Derfor skal patienterne afvente, hvordan behandlingen med Lamictal påvirker dem, før de fører motorkøretøj eller betjener maskiner.
English: A similar effect was seen during a study of lamotrigine and oxcarbazepine in healthy adult volunteers, but dose reduction was not investigated.
Danish: Der blev observeret en lignende effekt i et forsøg med lamotrigin og oxcarbazepin hos raske frivillige voksne, men dosisreduktion blev ikke undersøgt.
English: 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.
Danish: Effekten af andre doser lamotrigin end 300 mg dagligt er ikke blevet undersøgt, og der er ikke foretaget forsøg med andre hormonpræparater til kvinder.
English: During the pill-free week, a two-fold increase in lamotrigine levels has been observed.
Danish: Der er i den pillefrie uge blevet observeret en fordobling af lamotriginniveauerne.
English: * The Target stabilisation dose will alter depending on clinical response
Danish: * Målstabiliseringsdosis afhænger af den kliniske respons.
English: Myoclonic seizures may be worsened by lamotrigine.
Danish: Myokloniske anfald kan forværres ved lamotrigin.
English: To ensure a therapeutic dose is maintained the weight of a child must be monitored and the dose reviewed as weight changes occur.
Danish: For at sikre opretholdelsen af en terapeutisk dosis skal barnets vægt monitoreres, og dosis revurderes i takt med vægtændringerne.
English: The risk of congenital malformations is increased by a factor of 2 to 3 in the offspring of mothers treated with AEDs compared with the expected incidence in the general population of approximately 3%.
Danish: Risikoen for medfødte misdannelser øges med en faktor 2 til 3 hos børn af mødre, der behandles med antiepileptika, i forhold til den forventede incidens på ca. 3 % hos den almene befolkning.
English: These effects are likely to contribute to the anticonvulsant properties of lamotrigine.
Danish: Disse effekter bidrager sandsynligvis til lamotrigins antikonvulsive egenskaber.
English: Administration of lamotrigine resulted in a 15% increase in topiramate concentrations.
Danish: Administration af lamotrigin medførte en stigning i koncentrationen af topiramat på 15 %.
English: <Glaxo Wellcome GmbH & Co., Industriestrasse 32-36, 23843 Bad Oldesloe, Germany.>
Danish: Glaxo Wellcome GmbH & Co., Industriestrasse 32-36, 23843 Bad Oldesloe, Tyskland.
English: The indication will specify that the target population is “Children and adolescents aged 2 to 12 years“.
Danish: I indikationen vil det blive angivet, at målpopulationen er “Børn og unge på 2 til 12 år”.
English: aggression, irritability.
Danish: Aggressivitet, irritabilitet.
English: ANNEX IV CONDITION OF THE MARKETING AUTHORISATION(S)
Danish: BILAG IV BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Don't stop unless your doctor advises you to.
Danish: Afbryd ikke behandlingen, medmindre lægen beder dig om det.
English: Lamotrigine (the active substance of Lamictal) is a well-known anti-epileptic agent approved for the treatment of epileptic seizures in most EU-member states on a National basis.
Danish: Lamotrigin (det aktive stof i Lamictal) er et velkendt antiepileptikum, der i de fleste EUmedlemsstater er godkendt nationalt til behandling af epileptiske anfald.
English: Clearance and half-life are independent of dose.
Danish: Clearance og halveringstid er dosisuafhængige.
English: It is important to note that early manifestations of hypersensitivity (for example fever, lymphadenopathy) may be present even though rash is not evident.
Danish: Det er vigtigt at bemærke, at tidlige tegn på overfølsomhed (f.eks. feber, lymfadenopati) kan være til stede, selvom udslættet ikke er synligt.
English: Treatment was initiated in 177 subjects, with a dose titration schedule similar to that of children aged 2 to 12 years.
Danish: Behandlingen blev påbegyndt hos 177 forsøgspersoner med en dosistitreringsplan, der var omtrent den samme som for børn i alderen 2 til 12 år.
English: • Swallow your tablets whole.
Danish: • Synk tabletterne hele.
English: Lamictal is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy (see section 4.4).
Danish: Lamictal bør ikke anvendes til børn og unge under 18 år på grund af manglende dokumentation for sikkerhed og effekt (se pkt.
English: Although the disorder is a heterogeneous disease with contrasting therapeutic needs, it was recognised that depressive aspect is the most worrying and a drug able to prevent depressive episodes is therefore of value.
Danish: Selv om lidelsen er en heterogen lidelse med forskellige terapeutiske behov, var der enighed om, at det depressive aspekt var det, der gav anledning til størst bekymring, og at et lægemiddel, som var i stand til at forebygge depressive episoder, derfor var en fordel.
English: General dosing recommendations for Lamictal in special patient populations
Danish: Generelle anbefalinger til dosering af Lamictal hos særlige patientpopulationer
English: Therefore patients should be instructed to promptly report changes in their menstrual pattern, i.e. breakthrough bleeding.
Danish: Derfor skal patienterne rådes til straks at søge læge ved ændringer i deres menstruationsmønster, dvs. gennembrudsblødning.
English: The inter-individual variability for oral clearance was high in the group of paediatric patients of 2 to 26 months (47%).
Danish: Den interindividuelle variabilitet i den perorale clearance var høj i gruppen af børn i alderen 2 til 26 måneder (47 %).
English: The active ingredient of Lamictal passes into breast milk and may affect your baby.
Danish: Det aktive stof i Lamictal udskilles i modermælken og kan påvirke dit barn.
English: The pharmacokinetics of lamotrigine are linear up to 450 mg, the highest single dose tested.
Danish: Lamotrigins farmakokinetik er lineær op til 450 mg, der er den højeste afprøvede enkeltdosis.
English: • changes in liver function, which will show up in blood tests, or liver failure
Danish: • Ændringer i leverfunktionen, hvilket kan ses i blodprøver, eller leversvigt
English: There is considerable inter-individual variation in steady state maximum concentrations but within an individual, concentrations rarely vary.
Danish: Der er betydelige interindividuelle variationer i maksimumkoncentrationerne ved steady state, men koncentrationerne varierer sjældent hos den enkelte patient.
English: Norway GlaxoSmithKline AS Forskningsveien 2a Postbox 180 Vinderen N-0319 Oslo
Danish: GlaxoSmithKline AS Forskningsveien 2a Postbox 180 Vinderen N-0319 Oslo Norge
English: Potential interactions between levetiracetam and lamotrigine were assessed by evaluating serum concentrations of both agents during placebo-controlled clinical trials.
Danish: Potentielle interaktioner mellem levetiracetam og lamotrigin blev vurderet ved at måle serumkoncentrationerne af begge midler i placebokontrollerede kliniske forsøg.
English: Monotherapy should be the most desirable achievement, as the safety concerns tend to be reduced when only one drug is used, but at the present it is rarely obtained.
Danish: Monoterapi bør være det efterstræbte mål, da sikkerheden generelt er større, når der kun anvendes ét lægemiddel, men dette opnås for øjeblikket sjældent.
English: Thus Lamictal is not recommended for use in children below 2 years of age.
Danish: Lamictal bør derfor ikke anvendes til børn under 2 år.
English: Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogent potentiale.
English: LABELLING
Danish: ETIKITTERING
English: Additionally the overall risk of rash appears to be strongly associated with:
Danish: Derudover synes den samlede risiko for udslæt i høj grad at være forbundet med:
English: • Either stir to dissolve, or wait for about a minute, until the tablet is fully dissolved.
Danish: - Rør rundt for at opløse tabletten, eller vent i ca. 1 minut, indtil tabletten er helt opløst.
English: Although the majority recover on withdrawal of lamotrigine treatment, some patients experience irreversible scarring and there have been rare cases of associated death (see section 4.4).
Danish: Selvom de fleste kommer sig ved seponering af behandlingen med lamotrigin, oplever nogle patienter irreversibel ardannelse, og der har været sjældne tilfælde af associerede dødsfald (se pkt.
English: Lamotrigine induces its own metabolism to a modest extent depending on dose.
Danish: Lamotrigin inducerer i beskedent omfang sin egen metabolisering afhængigt af dosis.
English: • a severe skin reaction, starting with a painful red area, developing into large blisters then peeling of layers of skin (toxic epidermal necrolysis)
Danish: • En svær hudreaktion, der begynder med et smertefuldt rødt område og dernæst udvikler sig til store blærer og herefter afskalning af hudlag (toksisk epidermal nekrolyse)
English: 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.
Danish: Det skal overvejes at ændre det terapeutiske regimen, herunder muligvis seponere lægemidlet, hvis patienterne oplever en klinisk forværring (herunder udvikling af nye symptomer) og/eller fremkomst af selvmordstanker/-adfærd, især hvis disse symptomer er svære, debuterer pludseligt eller ikke var en del af patientens oprindelige symptomer.
English: Hungary GlaxoSmithKline Kft. 1124Bp.
Danish: Ungarn GlaxoSmithKline Kft. 1124Bp.
English: Your doctor will discuss the risks and benefits of breast feeding while you're taking Lamictal, and will check your baby from time to time if you decide to breast feed.
Danish: Lægen vil orientere dig om risiciene og fordelene ved at amme, mens du tager Lamictal, og undersøge dit barn fra tid til anden, hvis du vælger at amme.
English: 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%).
Danish: Sikkerhedsprofilen for lamotrigin hos børn i alderen 1 måned til 2 år var omtrent den samme som hos ældre børn, bortset fra at der oftere blev rapporteret om en klinisk signifikant forværring af anfaldene (>= 50 %) hos børn under 2 år (26 %) sammenlignet med ældre børn (14 %).
English: In addition, the patients studied were diagnosed with Bipolar I disorder; therefore the results of these studies may not be extrapolated to Bipolar II disorder.
Danish: Desuden havde de undersøgte patienter diagnosen bipolar I-lidelse, hvorfor resultaterne af disse undersøgelser ikke nødvendigvis kan overføres på bipolar II-lidelse.
English: Î See a doctor as soon as possible.
Danish: Î Skal du søge læge så hurtigt som muligt.
English: phenytoin carbamazepine phenobarbitone primidone rifampicin lopinavir/ritonavir
Danish: phenytoin carbamazepin phenobarbital primidon rifampicin lopinavir/ritonavir
English: The benefit/risk of lamotrigine as add-on treatment in primary generalised tonic clonic seizures in children is also considered favourable.
Danish: Risk/benefit-forholdet for lamotrigin ved tillægsbehandling af primære generaliserede tonisk-kloniske anfald hos børn anses også for at være gunstigt.
English: In a pooled analysis of psychiatric indications, events were more common in the first month of treatment, in patients taking lamotrigine.
Danish: I en poolet analyse af psykiatriske indikationer var hændelser mere almindelige i de første måneder af behandlingen hos patienter i behandling med lamotrigin.
English: WHAT LAMICTAL IS AND WHAT IT IS USED FOR
Danish: LAMICTALS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
English: It inhibits sustained repetitive firing of neurones and inhibits release of glutamate (the neurotransmitter which plays a key role in the generation of epileptic seizures).
Danish: Det hæmmer vedvarende, repetitive neuronale fyringer og frigivelse af glutamat (den neurotransmitter, der spiller en nøglerolle i udviklingen af epileptiske anfald).
English: Thirty-eight responders (> 40% decrease in seizure frequency) were randomised to placebo or continuation of lamotrigine.
Danish: 38 respondenter (reduktion i frekvensen af anfald på > 40 %) blev randomiseret til placebo eller fortsat behandling med lamotrigin.
English: People with bipolar disorder (sometimes called manic depression) have extreme mood swings, with periods of mania (excitement or euphoria) alternating with periods of depression (deep sadness or despair).
Danish: Personer med bipolar sygdom (undertiden kaldet maniodepressiv psykose) har voldsomme humørsvingninger med maniske perioder (opstemthed eller eufori), som veksler med perioder med depression (dyb nedtrykthed eller modløshed).
English: Major manic episode Lamotrigine Lithium Placebo Lamotrigine Lithium Placebo
Danish: Svær manisk episode Lamotrigin Lithium Placebo Lamotrigin Lithium Placebo
English: The apparent plasma half-life in healthy subjects is estimated to be approximately 33 hours (range 14 to 103 hours).
Danish: Den påviselige plasmahalveringstid hos raske forsøgspersoner estimeres til at være ca. 33 timer (varierer fra 14 til 103 timer).
English: 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.
Danish: Behandling med antidepressiva er forbundet med en øget risiko for selvmordstanker og -adfærd hos børn og unge med alvorlige depressioner og andre psykiske forstyrrelser.
English: • uncontrollable body movements (tics), uncontrollable muscle spasms affecting the eyes, head and torso (choreoathetosis), or other unusual body movements such as jerking, shaking or stiffness
Danish: • Ukontrollerede kropsbevægelser (tics), ukontrollerede muskelspasmer i øjne, hoved og overkrop (choreoathetosis) eller andre unormale kropsbevægelser som spjæt, rystelser eller stivhed
English: Available data from a number of studies suggest the incidence of rashes associated with hospitalisation in epileptic children is from 1 in 300 to 1 in 100.
Danish: Tilgængelige data fra en række forsøg indikerer, at incidensen af udslæt, som er forbundet med hospitalsindlæggelse, hos børn med epilepsi er mellem 1 ud af 300 og 1 ud af 100.
English: The proportion of subjects with treatment failure was 84% (16/19 subjects) in the placebo arm and 58% (11/19 subjects) in the lamotrigine arm.
Danish: Andelen af forsøgspersoner med behandlingssvigt var 84 % (16/19 forsøgspersoner) i placeboarmen og 58 % (11/19 forsøgspersoner) i lamotrigin-armen.
English: Should a woman decide to breast-feed while on therapy with lamotrigine, the infant should be monitored for adverse effects.
Danish: Hvis en kvinde beslutter sig for at amme, mens hun behandles med lamotrigin, skal spædbarnet monitoreres for bivirkninger.
English: The maintenance effect on typical absence seizures remains unclear, thus a warning will be included in the SPC stating that “In children taking lamotrigine for the treament of typical absence seizures, efficacy may not be maintained in all patients”.
Danish: Om virkningen kan fastholdes ved de typiske absenceanfald, er fortsat uklar, og der vil derfor blive indsat en advarsel i produktresuméet, der påpeger, at “Hos børn, der får lamotrigin til behandling af typiske absenceanfald, kan virkningen muligvis ikke fastholdes hos alle patienter”.
English: Manufacturer: <Glaxo Operations UK Limited (Trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, United Kingdom.>
Danish: Fremstiller: Glaxo Operations UK Limited (handler som Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, Storbritannien.
English: A mood stabilising claim implies the protection from both manic and depressive episodes.
Danish: En påstand om humørstabilisering omfatter både beskyttelse mod både maniske og depressive episoder.
English: If the calculated dose of lamotrigine (for example for treatment of children with epilepsy or patients with hepatic impairment) does not equate to whole tablets, the dose to be administered is that equal to the lower number of whole tablets.
Danish: Hvis den beregnede dosis lamotrigin (f.eks. til behandling af børn med epilepsi eller patienter med nedsat leverfunktion) ikke svarer til et helt antal tabletter, skal den anvendte dosis svare til laveste antal hele tabletter.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidality emerge.
Danish: Patienterne (og plejepersonalet) skal oplyses om at søge læge, hvis der forekommer tegn på suicidalitet.
English: In women being treated for epilepsy, sudden discontinuation of AED therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Danish: Antiepileptika må ikke seponeres pludseligt hos kvinder, der behandles mod epilepsi, da dette kan føre til gennembrudsanfald, som kan få alvorlige konsekvenser for kvinden og det ufødte barn.