FrancophonIA/ELRC3.0 huggingface dataset:
English: Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms (see Immune system disorders**).
Danish: Der er også rapporteret om udslæt som en del af et overfølsomhedssyndrom forbundet med et skiftende mønster af systemiske symptomer (se Immunsystemet**).
English: “Epilepsy
Danish: ”Epilepsi
English: Clinical worsening and suicide risk
Danish: Klinisk forværring og selvmordsrisiko forbundet med bipolar sygdom
English: A study in healthy adult volunteers evaluated the effect of repeat doses of lamotrigine (up to 400 mg/day) on cardiac conduction, as assessed by 12-lead ECG.
Danish: I et forsøg hos raske frivillige voksne blev effekten af gentagne doser lamotrigin (op til 400 mg/dag) på den kardiale ledning vurderet.
English: Lamotrigine reduced foetal folic acid levels in rats.
Danish: Lamotrigin reducerede det føtale niveau af folsyre hos rotter.
English: Discontinuation of Lamictal in patients with bipolar disorder In clinical trials, there was no increase in the incidence, severity or type of adverse reactions following abrupt termination of lamotrigine versus placebo.
Danish: Seponering af Lamictal hos patienter med bipolar sygdom Der var i kliniske forsøg ingen stigning i hverken incidensen eller sværhedsgraden af bivirkninger eller nogen ændring i typen af bivirkninger efter pludselig seponering af lamotrigin i forhold til placebo.
English: Î Talk to your doctor if you're pregnant, if you might be pregnant, or if you're planning to become pregnant.
Danish: Graviditet og amning Î Tal med lægen, hvis du er gravid, måske er gravid eller planlægger at blive gravid.
English: GlaxoSmithKline S.A Severo Ochoa 2
Danish: Spanien GlaxoSmithKline S.A Severo Ochoa 2
English: In patients with bipolar disorder, worsening of depressive symptoms and/or the emergence of suicidality may occur whether or not they are taking medications for bipolar disorder, including Lamictal.
Danish: Der kan forekomme forværring af depressive symptomer og/eller tegn på suicidalitet hos patienter med bipolar sygdom, uanset om de modtager behandling for sygdommen eller ej, herunder Lamictal.
English: In supportive analyses of time to first depressive episode and time to first manic/hypomanic or mixed episode, the lamotrigine-treated patients had significantly longer times to first depressive episode than placebo patients, and the treatment difference with respect to time to manic/hypomanic or mixed episodes was not statistically significant.
Danish: I supplerende analyser af tiden til den første depressive episode og tiden til den første maniske/hypomaniske eller blandede episode gik der signifikant længere tid til den første depressive episode hos patienter, som blev behandlet med lamotrigin, end hos patienter, som blev behandlet med placebo.
English: When concomitant AEDs are withdrawn or other AEDs/medicinal products are added on to treatment regimes containing lamotrigine, consideration should be given to the effect this may have on lamotrigine pharmacokinetics (see section 4.5).
Danish: Når samtidige antiepileptika seponeres, eller der føjes andre antiepileptika/lægemidler til behandlingsregimener med lamotrigin, skal der tages højde for den effekt, som dette kan have på lamotrigins farmakokinetik (se pkt.
English: Starting lamotrigine in patients already taking hormonal contraceptives Dose escalation should follow the normal dose recommendation described in the tables.
Danish: Initiering af behandling med lamotrigin hos patienter, som allerede tager hormonale kontraceptiva: Dosisøgningen skal følge den normale dosisanbefaling, der er beskrevet i tabellerne.
English: Phenobarbitone
Danish: Phenobarbital
English: What Lamictal dispersible/chewable tablets look like and contents of the pack Lamictal dispersible/chewable tablets (all strengths) are white to off-white, and may be slightly mottled.
Danish: Lamictal dispergible tabletter / tyggetabletters udseende og pakningsstørrelse Lamictal dispergible tabletter / tyggetabletter (alle styrker) er hvide til offwhite og kan være en anelse spættede.
English: This dosage regimen should be used when valproate is added regardless of any concomitant medicinal products
Danish: Dette dosisregimen skal følges, når valproat tilføjes, uanset om der administreres andre lægemidler samtidigt
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: 25, 50, 100 and 200 mg tablets: Lactose monohydrate Microcrystalline cellulose Povidone K30
Danish: 25, 50, 100 og 200 mg tabletter: Lactosemonohydrat Mikrokrystallinsk cellulose Povidon K30
English: Multiple oral doses of lamotrigine 400 mg daily had no clinically significant effect on the single dose pharmacokinetics of 2 mg risperidone in 14 healthy adult volunteers.
Danish: Gentagne perorale doser på 400 mg lamotrigin dagligt havde ingen klinisk signifikant effekt på farmakokinetikken af risperidon ved administration af enkeltdoser på 2 mg risperidon hos 14 raske frivillige voksne.
English: - Seizures associated with Lennox-Gastaut syndrome.
Danish: - Anfald associeret med Lennox-Gastaut-syndrom.
English: If epileptic control is achieved with adjunctive treatment, concomitant AEDs may be withdrawn and patients continued on Lamictal monotherapy.
Danish: Hvis der opnås kontrol med epilepsien med en tillægsbehandling, kan samtidige antiepileptika seponeres, og patienterne kan fortsætte med monoterapi med Lamictal.
English: Following titration, higher maintenance doses of lamotrigine (by as much as two-fold) may be needed to attain a maximal therapeutic response.
Danish: Efter titrering kan det være nødvendigt at øge vedligeholdelsesdosis af lamotrigin (med op til det dobbelte) for at opnå en maksimal terapeutisk respons.
English: Therapy aimed at decreasing absorption (activated charcoal, laxative or gastric lavage) should be performed if indicated.
Danish: Hvis der er indikation herfor, skal der foretages for at nedsætte absorptionen (aktiv kul, afføringsmiddel eller ventrikelskylning).
English: Caution should be exercised when administering Lamictal to patients with renal failure.
Danish: Der skal udvises forsigtighed, når Lamictal administreres til patienter med nedsat nyrefunktion.
English: Initial, escalation and maintenance doses should generally be reduced in patients with moderate or severe hepatic impairment (see section 4.2).
Danish: Initial-, øgnings- og vedligeholdelsesdosis skal generelt reduceres hos patienter med moderat eller svært nedsat leverfunktion (se pkt.
English: • shaking or tremors
Danish: • Rystelser eller tremor
English: 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.
Danish: Muligheden for en reaktion på behandlingen med lamotrigin skal tages i betragtning hos børn, som udvikler symptomer på udslæt og feber i løbet af de første otte uger af behandlingen.
English: Allergic reaction or potentially serious skin reaction: get a doctor's help straight away A small number of people taking Lamictal get an allergic reaction or potentially serious skin reaction, which may develop into more serious, and even life-threatening, problems if they are not treated.
Danish: Et fåtal af de mennesker, der tager Lamictal, får en allergisk reaktion eller mulig alvorlig hudreaktion, som kan udvikle sig til mere alvorlige og endda livstruende problemer, hvis de ikke behandles.
English: Multiple oral doses of bupropion had no statistically significant effects on the single dose pharmacokinetics of lamotrigine in 12 subjects and had only a slight increase in the AUC of lamotrigine glucuronide.
Danish: Gentagne perorale doser bupropion havde ingen statistisk signifikant effekt på farmakokinetikken ved administration af enkeltdoser af lamotrigin hos 12 forsøgspersoner og medførte kun en let stigning i AUC af lamotriginglukuronid.
English: Whereas, in controlled clinical trials with bipolar disorder patients, skin rashes occurred in 8% of patients taking lamotrigine and in 6% of patients taking placebo.
Danish: Derimod forekom der i kontrollerede kliniske forsøg hos patienter med bipolar sygdom hududslæt hos 8 % af de patienter, som fik lamotrigin, og hos 6 % af de patienter, som fik placebo.
English: Always use Lamictal exactly as your doctor has told you to.
Danish: Brug altid Lamictal nøjagtigt efter lægens anvisning.
English: Effect of lamotrigine on hormonal contraceptive pharmacokinetics In a study of 16 female volunteers, a steady state dose of 300 mg lamotrigine had no effect on the pharmacokinetics of the ethinyloestradiol component of a combined oral contraceptive pill.
Danish: Effekten af lamotrigin på hormonale kontraceptivas farmakokinetik I et forsøg med 16 frivillige kvinder havde en steady state-dosis på 300 mg lamotrigin ingen effekt på farmakokinetikken af ethinyløstradiol-komponenten i en kombineret peroral antikonceptionspille.
English: In patients receiving concomitant therapy with phenytoin, carbamazepine, pheonbarbitone or primidone, the appropriate treatment regimen should be used (see section 4.2).
Danish: Hos patienter, som får samtidig behandling med phenytoin, carbamazepin, phenobarbital eller primidon, skal der benyttes et hensigtsmæssigt behandlingsregimen (se pkt.
English: Rua Dr. António Loureiro Borges 3 ArquiparqueMiraflores
Danish: Rua Dr. António Loureiro Borges 3 Arquiparque - Miraflores 1495 - 131 Algés
English: Î Don't drive or operate machines unless you are sure you're not affected.
Danish: Î Du må kun køre bil, motorcykel, cykle eller arbejde med værktøj eller maskiner, hvis du er sikker på, at du ikke er påvirket.
English: BATCH NUMBER
Danish: senest {MM/ÅÅÅÅ} BATCHNUMMER
English: nystagmus, tremor, insomnia.
Danish: Nystagmus, tremor, søvnmangel.
English: Evidence from in vitro studies indicates that lamotrigine does not displace other AEDs from protein binding sites.
Danish: In vitro-forsøg indikerer, at lamotrigin ikke fortrænger andre antiepileptika fra proteinbindingsstederne.
English: Therefore, consideration should be given to using contraception without a pill-free week, as first-line therapy (for example, continuous hormonal contraceptives or non-hormonal methods).
Danish: Det skal derfor overvejes at bruge kontraceptiva uden en pillefri uge som førstevalgsbehandling (for eksempel kontinuerlige hormonale kontraceptiva eller ikke-hormonale metoder).
English: Middlesex UB11 1BT United Kingdom
Danish: Middlesex UB11 1BT Storbritannien
English: In a study in 10 male volunteers, rifampicin increased lamotrigine clearance and decreased lamotrigine half-life due to induction of the hepatic enzymes responsible for glucuronidation.
Danish: I et forsøg med 10 frivillige mandlige forsøgspersoner øgede rifampicin lamotrigins clearance og reducerede halveringstiden af lamotrigin som følge af induktion af de leverenzymer, der er ansvarlige for glukuronidering.
English: The seizures in some types of epilepsy may occasionally become worse or happen more often while you're taking Lamictal.
Danish: Hvis du tager Lamictal til behandling af epilepsi Nogle typer af epileptiske anfald kan sommetider blive værre eller forekomme oftere mens du tager Lamictal.
English: Current lamotrigine stabilisation dose (prior to withdrawal)
Danish: Aktuel stabiliseringsdosis af lamotrigin (før seponering)
English: Sodium starch glycolate (Type A) Iron oxide yellow (E172) Magnesium stearate.
Danish: Natriumstivelsesglycolat (type A) Gul jernoxid (E172) Magnesiumstearat.
English: Therefore patients receiving Lamictal for bipolar disorder should be closely monitored for clinical worsening (including development of new symptoms) and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes.
Danish: Patienter, som modtager Lamictal for bipolar sygdom, bør derfor overvåges nøje for klinisk forværring (herunder udvikling af nye symptomer) og suicidalitet.
English: Glaxo Wellcome House Berkeley Avenue
Danish: The Wellcome Foundation Limited Glaxo Wellcome House Berkeley Avenue
English: 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).
Danish: Serumkoncentrationerne af lamotrigin steg gradvist i løbet af ugen med inaktiv behandling (herunder den "pillefri" uge), og koncentrationerne før dosis i slutningen af ugen med inaktiv behandling var i gennemsnit ca. dobbelt så høje som ved samtidig behandling (se pkt.
English: Mean half-life is reduced to approximately 14 hours when given with glucuronidation-inducing medicinal products such as carbamazepine and phenytoin and is increased to a mean of approximately 70 hours when co-administered with valproate alone (see section 4.2).
Danish: Den gennemsnitlige halveringstid reduceres til ca. 14 timer, når lamotrigin administreres sammen med lægemidler, der inducerer glukuronidering, f.eks. carbamazepin og phenytoin, og øges til gennemsnitligt ca. 70 timer, når det administreres sammen med valproat alene (se pkt.
English: Therefore, patients may terminate Lamictal without a step-wise reduction of dose.
Danish: Behandlingen med Lamictal kan derfor seponeres uden gradvis dosisreduktion.
English: 8 9 10 11 12 13 14 (1 pocket)
Danish: 8 9 10 11 12 13 14 (1 lomme)
English: In clinical trials with lamotrigine adverse reactions of a neurological character such as dizziness and diplopia have been reported.
Danish: I kliniske forsøg med lamotrigin er der rapporteret om bivirkninger af neurologisk karakter, f.eks. svimmelhed og diplopi.
English: Lamictal is not indicated for the acute treatment of manic or depressive episodes.
Danish: Lamictal er ikke indiceret til akut behandling af maniske eller depressive episoder.
English: Belgium GlaxoSmithKline s.a. Rue du Tilleul 13, B86
Danish: Belgien GlaxoSmithKline s.a. Rue du Tilleul 13, B86
English: Apart from the indication in bipolar disorder the SPC of Lamictal in the different EU members show a large overlap.
Danish: Bortset fra indikationen bipolare lidelser er der store overlapninger i produktresuméerne for Lamictal i de forskellige EU-medlemsstater.
English: These have included potentially life-threatening rashes such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.8).
Danish: Disse tilfælde har omfattet potentielt livstruende udslæt som Stevens-Johnsons syndrom og toksisk epidermal nekrolyse (se pkt.
English: Following titration, higher maintenance doses of lamotrigine (by as much as two-fold) will be needed in most cases to attain a maximal therapeutic response.
Danish: Efter titrering vil det i de fleste tilfælde være nødvendigt at øge vedligeholdelsesdosis af lamotrigin (med op til det dobbelte) for at opnå en maksimal terapeutisk respons.
English: • valproate, used to treat epilepsy and mental health problems
Danish: • Valproat, der anvendes til behandling af epilepsi og psykiske problemer
English: hypersensitivity syndrome** (including such symptoms as, fever, lymphadenopathy, facial oedema, abnormalities of the blood and liver, disseminated intravascular coagulation, multi-organ failure).
Danish: Immunsystemet Meget sjælden: Overfølsomhedssyndrom** (herunder symptomer som feber, lymfadenopati, ansigtsødem, blod- og leverabnormiteter, dissemineret intravaskulær koagulation, multiorgansvigt).
English: • in people who already have Parkinson's disease, worsening of the symptoms.
Danish: • Forværring af symptomerne på Parkinsons sygdom hos patienter med denne lidelse.
English: 25, 50, 100 and 200 mg tablets, 5, 25, 50, 100 and 200 mg dispersible/chewable tablets: Three years.
Danish: 25, 50, 100 og 200 mg tabletter, 5, 25, 50, 100 og 200 mg dispergible tabletter / tyggetabletter: Tre år.
English: In a study in healthy volunteers, lopinavir/ritonavir approximately halved the plasma concentrations of lamotrigine, probably by induction of glucuronidation.
Danish: I et forsøg med raske frivillige forsøgspersoner blev plasmakoncentrationen af lamotrigin omtrent halveret ved brug af lopinavir/ritonavir, muligvis på grund af induktion af glukuronidering.
English: Mean clearances were 0.42 mL/min/kg (chronic renal failure), 0.33 mL/min/kg (between hemodialysis) and 1.57 mL/min/kg (during hemodialysis), compared with 0.58 mL/min/kg in healthy volunteers.
Danish: Den gennemsnitlige clearance var 0,42 ml/min./kg (kronisk nedsat nyrefunktion), 0,33 ml/min./kg (mellem hæmodialyser) og 1,57 ml/min./kg (under hæmodialyse) i forhold til 0,58 ml/min./kg hos raske frivillige.
English: Specialist advice should be given to women who are of childbearing potential.
Danish: Fødedygtige kvinder skal rådgives af en specialist.
English: The use of an ethinyloestradiol/levonorgestrel (30 µg/150 µg) combination increases the clearance of lamotrigine by approximately two-fold, resulting in decreased lamotrigine levels.
Danish: Brug af en kombination af ethinyløstradiol og levonorgestrel (30 µg/150 µg) omtrent fordobler lamotrigins clearance, hvilket medfører lavere lamotrigin-niveauer.
English: In a study of healthy volunteers, coadministration of felbamate (1200 mg twice daily) with lamotrigine (100 mg twice daily for 10 days) appeared to have no clinically relevant effects on the pharmacokinetics of lamotrigine.
Danish: I et forsøg, hvor raske frivillige fik både felbamat (1.200 mg to gange dagligt) og lamotrigin (100 mg to gange dagligt i 10 dage), havde den samtidige administration tilsyneladende ingen klinisk relevant effekt på lamotrigins farmakokinetik.
English: • swelling around your face, or swollen glands in your neck, armpit or groin
Danish: • Hævelser i ansigtet eller hævede kirtler på halsen, i armhulerne eller i lysken
English: Interactions involving antiepileptic drugs
Danish: Interaktioner med antiepileptika
English: Monotherapy:
Danish: Monoterapi:
English: • carbamazepine, used to treat epilepsy and mental health problems
Danish: • Carbamazepin, der anvendes til behandling af epilepsi og psykiske problemer
English: 8 9 10 11 12 13 14 (one pocket) 15 16 17 18 19 20 21 (two pockets) 22 23 24 25 26 27 28 (two pockets)
Danish: 8 9 10 11 12 13 14 (en lomme) 15 16 17 18 19 20 21 (to lommer) 22 23 24 25 26 27 28 (to lommer)
English: GROUNDS FOR AMENDMENT OF THE SUMMARYIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉERNE, ETIKETTERINGEN OG INDLÆGSSEDLEN
English: 15 16 17 18 19 20 21 (2 pockets)
Danish: 15 16 17 18 19 20 21 (2 lommer)
English: 2 mg dispersible/chewable tablets - where this is the lowest marketed strength: <* If the calculated daily dose in patients taking valproate is 1 mg or more but less than 2 mg, then Lamictal 2 mg dispersible/chewable tablets may be taken on alternate days for the first two weeks.
Danish: 2 mg dispergible tabletter / tyggetabletter - hvor dette er den laveste markedsførte styrke: * Hvis den beregnede daglige dosis til patienter, der tager valproat, er 1 mg eller derover, men under 2 mg, kan der tages Lamictal 2 mg dispergible tabletter / tyggetabletter hver anden dag i de første to uger.
English: Table 3: Adults aged 18 years and above - recommended dose escalation to the maintenance total daily stabilisation dose in treatment of bipolar disorder
Danish: Tabel 3: Voksne i alderen 18 år og derover - anbefalet dosisøgning til den samlede daglige vedligeholdende stabiliseringsdosis ved behandling af bipolar sygdom
English: Binding to plasma proteins is about 55%; it is very unlikely that displacement from plasma proteins would result in toxicity.
Danish: Det er meget usandsynligt, at fortrængningen fra plasmaproteiner vil resultere i toksicitet.
English: Albert-Schweitzer-Gasse 6 A-1140 Wien Austria
Danish: GlaxoSmithKline Pharma GmbH, Albert-Schweitzer-Gasse 6, A-1140 Wien, Østrig
English: Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom
Danish: Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN Storbritannien
English: Starter pack of 42 tablets.
Danish: Startpakning med 42 tabletter.
English: **Rash has also been reported as part of a hypersensitivity syndrome associated with a variable pattern of systemic symptoms including fever, lymphadenopathy, facial oedema and abnormalities of the blood and liver.
Danish: ** Der er også rapporteret om udslæt som en del af et overfølsomhedssyndrom, der er forbundet med et skiftende mønster af systemiske symptomer, herunder feber, lymfadenopati, ansigtsødem samt blodog leverabnormiteter.
English: Effects of lamotrigine on hormonal contraceptive efficacy An interaction study in 16 healthy volunteers has shown that when lamotrigine and a hormonal contraceptive (ethinyloestradiol/levonorgestrel combination) are administered in combination, there is a modest increase in levonorgestrel clearance and changes in serum FSH and LH (see section 4.5).
Danish: Effekten af lamotrigin på effekten af hormonale kontraceptiva Det er i et interaktionsforsøg med 16 raske frivillige blevet påvist, at administration af lamotrigin i kombination med et hormonalt kontraceptivum (kombination af ethinyløstradiol/levonorgestrel) medfører en beskeden stigning i clearance af levonorgestrel samt ændringer i niveauerne af FSH og LH i serum (se pkt.
English: 5 mg dispersible/chewable tablets - where 2 mg dispersible/chewable tablets are not marketed and 5 mg dispersible/chewable tablets are the lowest marketed strength: <It should be noted that with the currently available Lamictal 5 mg dispersible/chewable tablet strength, it is not possible to accurately initiate lamotrigine therapy using the recommended dosing guidelines in paediatric patients weighing less than 17 kg.>
Danish: 5 mg dispergible tabletter / tyggetabletter - hvor 2 mg dispergible tabletter / tyggetabletter ikke er markedsført, og 5 mg dispergible tabletter / tyggetabletter er den laveste markedsførte styrke: Det skal bemærkes, at det med den aktuelt tilgængelige Lamictal 5 mg dispergible tabletter / tyggetabletter styrke ikke er muligt helt nøjagtigt at initiere behandling med lamotrigin ved brug af de anbefalede retningslinjer for dosering hos børn, der vejer under 17 kg.
English: lamotrigine
Danish: Lamotrigin
English: Measurement of serum lamotrigine concentrations before and after starting hormonal contraceptives may be considered, as confirmation that the baseline concentration of lamotrigine is being maintained.
Danish: Det kan overvejes at måle lamotrigin-koncentrationen i serum før og efter initieringen af hormonale kontraceptiva for at få bekræftet, at baselinekoncentrationen af lamotrigin opretholdes.
English: 1 What Lamictal is and what it is used for 2 Before you take Lamictal 3 How to take Lamictal 4 Possible side effects 5 How to store Lamictal 6 Further information
Danish: Lamictals virkning og hvad du skal bruge det til Det skal du vide, før du begynder at tage Lamictal Sådan skal du tage Lamictal Bivirkninger
English: PVC/PVdC/aluminium foil blister.
Danish: Blisterpakning af PVC/PVdC/aluminiumsfolie.
English: Starting and stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and TAKING inducers of lamotrigine glucuronidation Adjustment to the recommended maintenance dose of lamotrigine may not be required.
Danish: Initiering og seponering af hormonale kontraceptiva hos patienter, som allerede tager vedligeholdelsesdoser af lamotrigin, og som TAGER induktorer af lamotrigin-glukuronidering: Det er muligvis ikke nødvendigt at justere dosis til den anbefalede vedligeholdelsesdosis af lamotrigin.
English: Efficacy as monotherapy treatment of typical absence seizures was demonstrated.
Danish: Det er påvist, at lægemidlet er effektivt til monoterapibehandling af typiske absenceanfald.
English: These may affect up to 1 in 10 people:
Danish: Disse forekommer hos op til 1 ud af 10 behandlede: