FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicines to treat depression and other mental health problems increase the risk of suicidal thoughts and behaviour in children and adolescents aged under 18 years.
Danish: Medicin til behandling af depression eller andre psykiske problemer øger risikoen for selvmordstanker og selvmordsadfærd hos børn og unge under 18 år.
English: Monotherapy in Lennox-Gastaut Syndrome is rarely achievable, as usually more than one medicinal product is needed to control the symptoms.
Danish: Monoterapi ved behandling af Lennox-Gastaut syndrom er sjældent mulig, da der normalt kræves mere end ét lægemiddel til at opnå kontrol med symptomerne.
English: Usually treatment is started as monotherapy; then if the control of the symptoms is not reached, other medicines are added based on the experience of the physician.
Danish: Almindeligvis indledes behandlingen som monoterapi, og hvis der ikke opnås kontrol med symptomerne, tilføjes andre lægemidler på baggrund af lægens erfaring.
English: lupus-like reactions.
Danish: Lupuslignende reaktioner.
English: Lamictal treats epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits).
Danish: Lamictal virker mod epilepsi ved at blokere de signaler i hjernen, der udløser epileptiske anfald.
English: The efficacy of lamotrigine in combination with mood stabilisers has not been adequately studied.
Danish: Effekten af lamotrigin i kombination med stemningsstabiliserende lægemidler er ikke blevet tilstrækkeligt undersøgt.
English: The recommended dose escalation and maintenance doses for adults and adolescents aged 13 years and above (Table 1) and for children and adolescents aged 2 to 12 years (Table 2) are given below.
Danish: Den anbefalede dosisøgning og de anbefalede vedligeholdelsesdoser til voksne og unge i alderen 13 år og derover (tabel 1) og til børn i alderen 2-12 år (tabel 2) er angivet nedenfor.
English: Î Tell your doctor if you are taking, or if you start or stop taking, any of these.
Danish: Î Fortæl det til lægen, hvis du tager, begynder at tage eller holder op med at tage nogle af disse lægemidler.
English: Occasionally, people with epilepsy may also have thoughts of harming themselves or committing suicide.
Danish: Sommetider kan epilepsi-patienter også have tanker om at skade sig selv eller begå selvmord.
English: Clearance of lamotrigine is primarily metabolic with subsequent elimination of glucuronide-conjugated material in urine.
Danish: Lamotrigins clearance er primært metabolisk med efterfølgende elimination af glukuronidkonjugerede bestanddele i urinen.
English: In addition, a study of bufuralol metabolism using human liver microsome preparations suggested that lamotrigine would not reduce the clearance of medicinal products metabolised predominantly by CYP2D6.
Danish: Derudover indikerede et forsøg, hvor metaboliseringen af bufuralol blev undersøgt ved brug af præparater med humant levermikrosom, at lamotrigin ikke vil nedsætte clearance af lægemidler, der primært metaboliseres af CYP2D6.
English: The other side is marked with two overlapping super-ellipses at right angles.
Danish: Den anden side har to overlappende superellipser, der ligger vinkelret på hinanden.
English: If you have an intolerance to lactose or any other sugars:
Danish: Hvis du ikke kan tåle lactose eller andre sukkerarter
English: In the clinical practice, the approved drugs for Bipolar disorder generally need to be combined to achieve an acceptable control of the symptoms.
Danish: I klinisk praksis er der almindeligvis behov for at kombinere de godkendte midler til bipolar lidelse for at opnå tilfredsstillende kontrol med symptomerne.
English: - Clinical aspects
Danish: - Kliniske aspekter
English: Therapeutic Indications (SPC section 4.1)
Danish: Terapeutiske indikationer (afsnit 4.1 i produktresuméet)
English: However, accumulation of the glucuronide metabolite is to be expected; caution should therefore be exercised in treating patients with renal failure.
Danish: Der kan dog forventes en akkumulering af glukuronidmetabolitten, og derfor skal der udvises forsigtighed ved behandling af patienter med nedsat nyrefunktion.
English: Caution is also required when treating patients with a history of allergy or rash to other AEDs as the frequency of non-serious rash after treatment with lamotrigine was approximately three times higher in these patients than in those without such history.
Danish: Der skal også udvises forsigtighed ved behandling af patienter med kendt allergi over for eller udslæt i forbindelse med andre antiepileptika, da hyppigheden af ikke-alvorligt udslæt efter behandling med lamotrigin var ca. tre gange højere hos disse patienter end hos patienter uden en sådan anamnese.
English: The efficacy and safety of adjunctive therapy in partial seizures in patients aged 1 to 24 months has been evaluated in a small double-blind placebo-controlled withdrawal study.
Danish: Effekten af og sikkerheden ved tillægsbehandling af partielle anfald hos patienter i alderen 1 til 24 måneder er blevet vurderet i et lille, dobbeltblindet, placebokontrolleret seponeringsforsøg.
English: The age range will be modified to reflect the ages for which supporting data are available, adults and patients aged 13 years and older (adolescents).
Danish: Aldersintervallet vil blive justeret, så det afspejler de aldersgrupper, for hvilke der foreligger underbyggende data, nemlig voksne og patienter på 13 år og derover (unge).
English: Although the Marketing Authorisation Holder has not conducted specific studies with lamotrigine monotherapy solely in patients with primary generalised tonic clonic seizures, data from controlled initial monotherapy studies (studies UK49/89, UK74) reassure on the efficacy of lamotrigine on this seizure types.
Danish: Selv om indehaveren af markedsføringstilladelsen ikke har gennemført specifikke undersøgelser med lamotrigin-monoterapi udelukkende hos patienter med primære generaliserede tonisk-kloniske anfald, bekræfter data fra kontrollerede initiale monoterapi-undersøgelser (undersøgelse UK49/89 og UK74) lamotrigins virkning på disse anfaldstyper.
English: This referral is undertaken following concerns related to divergent decisions on approval of the bipolar indication for lamotrigine across EU Member States.
Danish: Denne indbringelse skyldes betænkeligheder vedrørende EU-medlemsstaternes divergerende beslutninger med hensyn til godkendelsen af indikationen bipolar lidelse for lamotrigin.
English: 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.
Danish: I alt 256 forsøgspersoner i alderen 1 til 24 måneder er blevet eksponeret for lamotrigin i dosisintervallet 1-15 mg/kg/dag i op til 72 uger.
English: The risk of serious skin rashes in children is higher than in adults.
Danish: Risikoen for alvorlige hududslæt er højere hos børn end hos voksne.
English: Hepatic dysfunction usually occurs in association with hypersensitivity reactions but isolated cases have been reported without overt signs of hypersensitivity.
Danish: Hepatisk dysfunktion forekommer normalt i forbindelse med overfølsomhedsreaktioner, men der er rapporteret om enkeltstående tilfælde uden åbenlyse tegn på overfølsomhed.
English: The overall risk of rash, appears to be strongly associated with:
Danish: Den samlede risiko for udslæt synes i høj grad at være forbundet med:
English: All patients (adults and children) who develop a rash should be promptly evaluated and Lamictal withdrawn immediately unless the rash is clearly not related to lamotrigine treatment.
Danish: Alle patienter (voksne og børn), som udvikler udslæt, skal straks undersøges, og Lamictal skal omgående seponeres, medmindre udslættet helt klart ikke er forbundet med behandlingen med lamotrigin.
English: The need for treatment with AEDs should be reviewed when a woman is planning to become pregnant.
Danish: Behovet for behandling med antiepileptika skal vurderes, når en kvinde planlægger at blive gravid.
English: Although the number of suicidal ideation and behaviour events was too low (6/1073 [0.6%] on lamotrigine and 2/805 [0.3%] on placebo) to allow a definitive comparison between treatment groups, the relative rate reported from this lamotrigine analysis is consistent with the reported class effect for AEDs (see section 4.4).
Danish: Selvom antallet af selvmordstanker og -handlinger var for lav (6/1073 [0,6 %] for lamotrigin og 2/805 [0,3 %] for placebo) til at foretage en definitiv sammenligning mellem behandlingsgrupperne, er den relative mængde rapporteret fra denne lamotrigin-analyse i overensstemmelse med den rapporterede klasseeffekt for antiepileptika (se pkt.
English: Samples for assessment of lamotrigine levels after permanently stopping the contraceptive pill should not be collected during the first week after stopping the pill.
Danish: Prøverne til vurdering af lamotrigin-niveauerne efter permanent seponeringen af den kontraceptive pille må ikke tages i den første uge efter seponeringen.
English: The dose adjustments following addition of other psychotropic medicinal products and/or AEDs are also provided below (Table 5).
Danish: De dosisjusteringer, der skal foretages efter tilføjelse af andre psykofarmaka og/eller antiepileptika, er ligeledes anført nedenfor (tabel 5).
English: There are reports in the literature of decreased lamotrigine levels when lamotrigine was given in combination with oxcarbazepine.
Danish: I litteraturen er rapporteret aftagende mængde af lamotrigin, når lamotrigin er givet i kombination med oxcarbazepin.
English: A small number of people being treated with Lamictal for bipolar disorder or epilepsy have had these thoughts.
Danish: Et lille antal patienter, som har været i behandling med Lamictal mod bipolar sygdom eller epilepsi har haft disse tanker.
English: Interactions involving other medicinal products
Danish: Interaktioner med andre lægemidler
English: The apparent plasma clearance in healthy subjects is approximately 30 mL/min.
Danish: Den påviselige plasmaclearance hos raske forsøgspersoner er ca. 30 ml/min.
English: Peak plasma concentrations occur approximately 2.5 hours after oral administration of lamotrigine.
Danish: De maksimale plasmakoncentrationer nås ca. 2,5 timer efter peroral administration af lamotrigin.
English: Risk related to antiepileptic drugs in general
Danish: Risici i forbindelse med antiepileptika i almindelighed
English: LIST OF EXCIPIENTS Contains lactose monohydrate - see package leaflet for further information
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactosemonohydrat - se indlægsseddel for yderligere information
English: Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly-le-Roi Cedex France
Danish: Frankrig Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly-le-Roi Cedex Frankrig
English: Lamotrigine 2 mg tablets are the lowest strength available, therefore the standard dosing schedule was adapted in some cases during the titration phase (for example, by administering a 2 mg tablet on alternate days when the calculated dose was less than 2 mg).
Danish: Lamotrigin-tabletter med 2 mg er den laveste styrke, som fås, og derfor blev den almindelige doseringsplan i visse tilfælde tilpasset i løbet af titreringsfasen (eksempelvis ved at administrere en tablet med 2 mg hver anden dag, når den beregnede dosis var lavere end 2 mg).
English: After birth lamotrigine levels may increase rapidly with a risk of dose-related adverse events.
Danish: Efter fødslen kan niveauerne af lamotrigin stige hurtigt med en risiko for dosisrelaterede hændelser.
English: The dose you take will depend on:
Danish: Dosis afhænger af:
English: On average, approximately 20% (range = 5.6 to 35.1) of the amount of lamotrigine present in the body was eliminated during a 4-hour hemodialysis session.
Danish: I gennemsnit blev ca. 20 % (med et interval på 5,6 til 35,1 %) af den mængde lamotrigin, der var i kroppen, elimineret i løbet af 4 timers hæmodialyse.
English: • changes which may show up in blood tests - including reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia, neutropenia, agranulo-cytosis), reduced numbers of platelets (thrombocytopenia), reduced numbers of all these types of cell (pancytopenia), and a disorder of the bone marrow called aplastic anaemia
Danish: • Ændringer, der muligvis kan ses i blodprøver, herunder fald i antallet af røde blodlegemer (anæmi), fald i antallet af hvide blodlegemer (leukopeni, neutropeni, agranulocytose), fald i antallet af blodplader (trombocytopeni), fald i antallet af alle disse typer celler (pancytopeni) samt en knoglemarvslidelse, der kaldes aplastisk anæmi
English: Take your dose of Lamictal once or twice a day, as your doctor advises.
Danish: Lamictal skal tages én eller to gange om dagen, alt efter hvad lægen foreskriver.
English: The predicted serum concentration levels in children of 2 to 26 months were in general in the same range as those in older children, though higher Cmax levels are likely to be observed in some children with a body weight below 10 kg.
Danish: De forventede serumkoncentrationer hos børn på 2 til 26 måneder lå generelt inden for samme interval som hos ældre børn, selvom der sandsynligvis vil blive observeret højere Cmax-niveauer hos nogle børn med en legemsvægt på under 10 kg.
English: * Dose may be increased to 400 mg/day as needed
Danish: * Dosis kan øges til 400 mg dagligt efter behov.
English: • Add a little more water to the glass and drink that, to make sure you've taken all the medicine.
Danish: - Hæld lidt mere vand i glasset, og drik det for at sikre, at du har taget al medicinen.
English: A CNS Scientific Advisory Group (SAG) was also consulted to advise the CHMP on Bipolar disorder and its treatment.
Danish: CHMP konsulterede desuden en videnskabelig rådgivende gruppe vedrørende CNS med henblik på rådgivning vedrørende bipolar lidelse og behandling heraf.
English: • a rare skin condition, with severe blisters, and bleeding from the lips, eyes, mouth, nose and genital area (Stevens-Johnson syndrome).
Danish: • En sjælden hudtilstand med svær blæredannelse og blødning fra læber, øjne, mund, næse og kønsorganer (Stevens-Johnsons syndrom).
English: Table 2: Children and adolescents aged 2 to 12 years - recommended treatment regimen in epilepsy (total daily dose in mg/kg body weight/day)
Danish: Tabel 2: Børn og unge i alderen 2-12 år - anbefalet behandlingsregimen ved epilepsi (samlet daglig dosis i mg/kg legemsvægt/dag)
English: If you have bipolar disorder, you may be more likely to think like this:
Danish: Hvis du har bipolar sygdom, kan du have disse tanker:
English: Based on a retrospective analysis of plasma levels in patients who received lamotrigine both with and without gabapentin, gabapentin does not appear to change the apparent clearance of lamotrigine.
Danish: På basis af en retrospektiv analyse af plasmaniveauet hos patienter, der fik lamotrigin både med og uden gabapentin, synes gabapentin ikke at ændre den påviselige clearance af lamotrigin.
English: In 143 paediatric patients aged 2 to 26 months, weighing 3 to 16 kg, clearance was reduced compared to older children with the same body weight, receiving similar oral doses per kg body weight as children older than 2 years.
Danish: Hos 143 børn i alderen 2 til 26 måneder, som vejede fra 3 til 16 kg, var clearance nedsat sammenlignet med ældre børn med samme legemsvægt, der modtog samme perorale doser pr. kilo legemsvægt som børn over 2 år.
English: It is recommended to gradually decrease the daily dose of lamotrigine by 50100 mg each week (at a rate not exceeding 25% of the total daily dose per week) over a period of 3 weeks, unless the clinical response indicates otherwise.
Danish: Dette anbefales gradvist at reducere den daglige dosis lamotrigin med 50-100 mg hver uge (med en frekvens, der ikke overskrider 25 % af den samlede daglige dosis pr. uge) over en periode på tre uger, medmindre den kliniske respons giver anledning til andet.
English: Week 1 (beginning with withdrawal)
Danish: Uge 1 (starter ved seponeringen)
English: 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.
Danish: Der foreligger rapporter om, at lamotrigin kan forværre symptomer på Parkinsons sygdom hos patienter med eksisterende Parkinsons sygdom, og der er enkeltstående rapporter om ekstrapyramidale effekter og choreoathetosis hos patienter uden denne grundsygdom.
English: If this applies to you: Î Tell your doctor, and don't take Lamictal.
Danish: Hvis dette gælder for dig, Î skal du fortælle det til lægen og lade være med at tage Lamictal.
English: Table 1: Adults and adolescents aged 13 years and above - recommended treatment regimen in epilepsy
Danish: Tabel 1: Voksne og unge i alderen 13 år og derover - anbefalet behandlingsregimen ved epilepsi Behandlingsregimen
English: Measurement of serum FSH, LH and oestradiol during the study indicated some loss of suppression of ovarian hormonal activity in some women, although measurement of serum progesterone indicated that there was no hormonal evidence of ovulation in any of the 16 subjects.
Danish: Målinger af FSH, LH og østradiol i serum under forsøget indikerede en delvist reduceret undertrykkelse af ovariernes hormonale aktivitet hos nogle kvinder, selvom målinger af progesteron i serum tydede på, at der ikke var hormonale tegn på ægløsning hos nogen af de 16 forsøgspersoner.
English: 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.
Danish: Forekomsten af selvmordstanker og -handling er blevet evalueret i en poolet analyse af placebokontrolleret kliniske forsøg for lamotrigin, hvor 6467 patienter, med forskellige indikationer, er blevet involveret.
English: GSK d.o.o.
Danish: Slovenien GSK d.o.o.
English: The potential benefits of breast-feeding should be weighed against the potential risk of adverse effects occurring in the infant.
Danish: De potentielle fordele ved amning skal opvejes mod den potentielle risiko for bivirkninger hos spædbarnet.
English: This dosage regimen should be used when the following are withdrawn:
Danish: Dette dosisregimen skal følges, når følgende midler seponeres:
English: These events usually resolve when the dose of carbamazepine is reduced.
Danish: Disse bivirkninger forsvinder sædvanligvis efter dosisreduktion af carbamazepin.
English: Initial, escalation and maintenance doses should generally be reduced by approximately 50% in patients with moderate (Child-Pugh grade B) and 75% in severe (Child-Pugh grade C) hepatic impairment.
Danish: Initial-, øgnings- og vedligeholdelsesdosis skal generelt reduceres med ca. 50 % hos patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) og med 75 % ved svært nedsat leverfunktion (Child-Pugh klasse C).
English: When stopping hormonal contraceptives, the clearance of lamotrigine may be halved.
Danish: Ved seponering af hormonale kontraceptiva kan lamotrigins clearance blive halveret.
English: 1 - 10 mg/kg/day, although some patients have required higher doses (up to 15 mg/kg/day) to achieve desired response (once a day or two divided doses)
Danish: 1-10 mg/kg/dag, selvom nogle patienter har haft behov for højere doser (op til 15 mg/kg/dag) for at opnå den ønskede respons (én gang dagligt eller fordelt på to doser)
English: <GlaxoSmithKline EOOD, Gradinarska Street 5, Sofia 1510, Bulgaria.>
Danish: GlaxoSmithKline EOOD, Gradinarska Street 5, Sofia 1510, Bulgarien.
English: If you forget to take Lamictal Don't take extra tablets or a double dose to make up for a forgotten dose.
Danish: Hvis du har glemt at tage Lamictal Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The skin rashes led to the withdrawal of lamotrigine treatment in 2% of patients.
Danish: Hududslættene førte til seponering af behandlingen med lamotrigin hos 2 % af patienterne.
English: Some medicines interact with Lamictal or make it more likely that you'll have side effects.
Danish: Noget medicin påvirker den måde, Lamictal virker på, eller gør det mere sandsynligt, at du får bivirkninger.
English: METHOD AND ROUTE OF ADMINISTRATION Oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse
English: Epidemiological studies involving in total approximately 2000 women exposed to lamotrigine monotherapy during pregnancy cannot exclude an increased risk for congenital malformations.
Danish: På basis af epidemiologiske forsøg hos i alt ca. 2.000 kvinder, som under graviditeten blev eksponeret for monoterapi med lamotrigin, kan det ikke udelukkes, at der er en øget risiko for medfødte misdannelser.
English: Results of a population pharmacokinetic analysis including both young and elderly patients with epilepsy, enrolled in the same trials, indicated that the clearance of lamotrigine did not change to a clinically relevant extent.
Danish: Resultaterne af en farmakokinetisk populationsanalyse af både unge og ældre patienter med epilepsi, som var inkluderet i de samme forsøg, indikerede, at lamotrigins clearance ikke ændrer sig i et klinisk relevant omfang.
English: However, the possibility of these changes resulting in decreased contraceptive efficacy in some patients taking hormonal preparations with lamotrigine cannot be excluded.
Danish: Det kan dog ikke udelukkes, at disse forandringer medfører en nedsat kontraceptiv effekt hos nogle patienter, som tager hormonpræparater sammen med lamotrigin.
English: • difficulty in sleeping
Danish: • Søvnproblemer
English: The results indicate that the drug substance and drug product can be reproducibly manufactured.
Danish: Resultaterne viser, at det aktive stof og lægemidlet kan fremstilles ens hver gang.
English: The Marketing Authorisation Holder commits to timely submission of MR/national variations to implement labelling changes, which may be agreed following Pharmacovigilance Working Party (PhVWP) recommendation concerning suicidal ideation and behaviour with anti-epileptic drugs.
Danish: Indehaveren af markedsføringstilladelsen forpligter sig til rettidigt at forelægge ændringer i henhold til den gensidige anerkendelsesprocedure/den nationale procedure med henblik på gennemførelse af ændringer af etiketteringen, som måtte blive vedtaget efter anbefaling fra arbejdsgruppen for lægemiddelovervågning vedrørende selvmordstanker og -adfærd i forbindelse med anvendelse af lægemidler mod epilepsi.
English: There have been reports of decreased lamotrigine plasma levels during pregnancy with a potential risk of loss of seizure control.
Danish: Der er rapporteret om fald i plasmaniveauerne af lamotrigin under graviditet med en potentiel risiko for en dårligere kontrol af anfald.
English: Maximum dose of 200 mg/day can be used depending on clinical response
Danish: Der må maksimalt gives en dosis på 200 mg/dag afhængigt af den kliniske respons
English: There is no experience with haemodialysis as treatment of overdose.
Danish: Der foreligger ingen erfaring med hæmodialyse som behandling af overdosering.
English: The CHMP was concerned about the suitability of lamotrigine used as mood stabiliser.
Danish: CHMP var betænkelig ved, hvorvidt lamotrigin var egnet som humørstabilisator.
English: Hormonal contraceptives (such as the Pill) can affect the way Lamictal works Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, a cap or a coil.
Danish: Hormonale svangerskabsforebyggende midler (f.eks. p-piller) kan påvirke effekten af Lamictal Lægen kan anbefale, at du bruger en bestemt form for hormonalt svangerskabsforebyggende middel eller en anden svangerskabsforebyggende metode, f.eks. kondomer, pessar eller spiral.
English: agitation, unsteadiness, movement disorders, worsening of Parkinson's disease, extrapyramidal effects, choreoathetosis, increase in seizure frequency.
Danish: Agitation, usikkerhed på benene, bevægeforstyrrelser, forværring af Parkinsons sygdom, ekstrapyramidale effekter, choreoathetosis, stigning i frekvensen af krampeanfald.