natgillin/translations-raw huggingface dataset:
* Dosis kan øges til 400 mg dagligt efter behov.
* Dose may be increased to 400 mg/ day as needed
55 Tabel 5:
54 Table 5:
Voksne i alderen 18 år og derover – justering af den daglige lamotrigin- dosis efter tilføjelse af andre lægemidler ved behandling af bipolar sygdom
Adults aged 18 years and above - adjustment of lamotrigine daily dosing following the addition of other medicinal products in treatment of bipolar disorder There is no clinical experience in adjusting the lamotrigine daily dose following the addition of other medicinal products.
Uge 3 og frem
Week 3 onwards
Tilføjelse af valproat (hæmmer af lamotrigin- glukuronidering – se pkt.
Addition of valproate (inhibitor of lamotrigine glucuronidation – see section 4.5), depending on original dose of lamotrigine:
4. 5) afhængigt af den oprindelige dosis lamotrigin:
200 mg/ day
Dette dosisregimen skal følges, når 200 mg/ dag valproat tilføjes, uanset om der administreres andre lægemidler 300 mg/ dag samtidigt 400 mg/ dag
100 mg/ day Maintain this dose (100 mg/ day)
100 mg/ dag Oprethold denne dosis (100 mg/ dag) 150 mg/ dag Oprethold denne dosis (150 mg/ dag) 200 mg/ dag Oprethold denne dosis (200 mg/ dag)
150 mg/ day Maintain this dose (150 mg/ day)
Tilføjelse af induktorer af lamotrigin- glukuronidering hos 4. 5), afhængigt af den oprindelige dosis lamotrigin:
200 mg/ day
patienter, der IKKE tager valproat (se pkt.
200 mg/ day 300 mg/ day
Dette dosisregimen skal følges, når 200 mg/ dag følgende midler tilføjes, og der ikke
150 mg/ day 225 mg/ day
200 mg/ dag 300 mg/ dag 400 mg/ dag
300 mg/ day
tages valproat:
100 mg/ day 100 mg/ day
100 mg/ dag 150 mg/ dag 200 mg/ dag
200 mg/ day
4. 5):
Addition of medicinal products that do NOT significantly inhibit or induce lamotrigine glucuronidation (see section 4.5):
Dette dosisregimen skal følges, når Oprethold den måldosis, der er opnået ved dosisøgning (200 mg/ dag, andre lægemidler, der ikke signifikant hæmmer eller inducerer glukuronidering af lamotrigin, tilføjes
This dosage regimen should be used when other medicinal products that do not significantly inhibit or induce lamotrigine glucuronidation are added
dosisinterval 100- 400 mg/ dag)
Maintain target dose achieved in dose escalation (200 mg/ day; dose range 100-400 mg/ day)
4. 4).
Children and adolescents below 18 years 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).
56 Generelle anbefalinger til dosering af Lamictal hos særlige patientpopulationer
55 General dosing recommendations for Lamictal in special patient populations
Kvinder, som tager hormonale kontraceptiva Brug af en kombination af ethinyløstradiol og levonorgestrel (30 µg/ 150 µg) omtrent fordobler lamotrigins clearance, hvilket medfører lavere lamotrigin- niveauer.
Women taking hormonal contraceptives 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.
Der er i den pillefrie uge blevet observeret en fordobling af lamotrigin - niveauerne.
During the pill-free week, a two-fold increase in lamotrigine levels has been observed.
4. 4 og 4. 5).
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; see sections 4.4 and 4.5).
Vedligeholdelsesdosen af lamotrigin skal i de fleste tilfælde øges med op til det dobbelte (se pkt.
Starting hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers of lamotrigine glucuronidation The maintenance dose of lamotrigine will in most cases need to be increased by as much as two-fold (see sections 4.4 and 4.5).
Det anbefales at øge lamotrigin- dosis med 50 til 100 mg/ dag hver uge i henhold til den enkelte patients kliniske respons fra det tidspunkt, hvor det hormonale kontraceptivum initieres.
It is recommended that from the time that the hormonal contraceptive is started, the lamotrigine dose is increased by 50 to 100 mg/ day every week, according to the individual clinical response.
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.
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.
Hos kvinder, som tager et hormonalt kontraceptivum, hvor der indgår en uge med inaktiv behandling ("pillefri uge"), skal der foretages monitorering af lamotrigin- niveauet i serum i uge 3 af den aktive behandling, dvs. på dag 15 til 21 i pillecyklussen.
In women taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i. e. on days 15 to 21 of the pill cycle.
4. 4 og 4. 5)
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; see sections 4.4 and 4.5).
4. 4 og 4. 5).
Stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers of lamotrigine glucuronidation The maintenance dose of lamotrigine will in most cases need to be decreased by as much as 50% (see sections 4.4 and 4.5).
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.
It is recommended to gradually decrease the daily dose of lamotrigine by 50- 100 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.
Det kan overvejes at måle lamotrigin - koncentrationen i serum før og efter seponeringen af hormonale kontraceptiva for at få bekræftet, at baselinekoncentrationen af lamotrigin opretholdes.
Measurement of serum lamotrigine concentrations before and after stopping hormonal contraceptives may be considered, as confirmation that the baseline concentration of lamotrigine is being maintained.
Hos kvinder, som ønsker at stoppe og som tager et hormonalt kontraceptivum, hvor der indgår en uge med inaktiv behandling ("pillefri uge"), skal der foretages monitorering af lamotrigin- niveauet i serum i uge 3 af den aktive behandling, dvs. på dag 15 til 21 i pillecyklussen.
In women who wish to stop taking a hormonal contraceptive that includes one week of inactive treatment ("pill-free week"), serum lamotrigine level monitoring should be conducted during week 3 of active treatment, i. e. on days 15 to 21 of the pill cycle.
Prøverne til vurdering af lamotrigin- niveauerne efter permanent seponeringen af den kontraceptive pille må ikke tages i den første uge efter seponeringen.
Samples for assessment of lamotrigine levels after permanently stopping the contraceptive pill should not be collected during the first week after stopping the pill.
Dosisøgningen skal følge den normale dosisanbefaling, der er beskrevet i tabellerne.
Starting lamotrigine in patients already taking hormonal contraceptives Dose escalation should follow the normal dose recommendation described in the tables.
Det er muligvis ikke nødvendigt at justere dosis til den anbefalede vedligeholdelsesdosis af lamotrigin.
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.
Ældre (over 65 år) Dosisjustering i forhold til den anbefalede doseringsplan er ikke nødvendig.
Elderly (above 65 years) No dosage adjustment from the recommended schedule is required.
5. 2).
The pharmacokinetics of lamotrigine in this age group do not differ significantly from a non-elderly adult population (see section 5.2).
Patienter med nedsat nyrefunktion Der skal udvises forsigtighed, når Lamictal administreres til patienter med nedsat nyrefunktion.
Renal impairment Caution should be exercised when administering Lamictal to patients with renal failure.
4. 4 og 5. 2).
For patients with end-stage renal failure, initial doses of lamotrigine should be based on patients' concomitant medicinal products; reduced maintenance doses may be effective for patients with significant renal functional impairment (see sections 4.4 and 5.2).
50% hos patienter med moderat nedsat leverfunktion (Child- Pugh klasse B) og med 75% ved svært nedsat leverfunktion (Child- Pugh klasse C).
56 Hepatic impairment 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.
5. 2).
Escalation and maintenance doses should be adjusted according to clinical response (see section 5.2).
4. 8).
These have included potentially life-threatening rashes such as Stevens– Johnson syndrome and toxic epidermal necrolysis (see section 4.8).
1 ud af 500 hos patienter med epilepsi.
In adults enrolled in studies utilizing the current lamotrigine dosing recommendations the incidence of serious skin rashes is approximately 1 in 500 in epilepsy patients.
Ca. halvdelen af disse tilfælde er rapporteret som Stevens- Johnsons syndrom (1 ud af 1. 000).
Approximately half of these cases have been reported as Stevens– Johnson syndrome (1 in 1000).
1 ud af 1. 000.
In clinical trials in patients with bipolar disorder, the incidence of serious rash is approximately 1 in 1000.
Høj initialdosis og overskridelse af den anbefalede dosisøgning af lamotrigin (se pkt.
high initial doses of lamotrigine and exceeding the recommended dose escalation of lamotrigine therapy (see section 4.2)
4. 2).
concomitant use of valproate (see section 4.2).
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.
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.
4. 8).
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 (see section 4.8).
Det er vigtigt at bemærke, at tidlige tegn på overfølsomhed (f. eks. feber, lymfadenopati) kan være til stede, selvom udslættet ikke er synligt.
It is important to note that early manifestations of hypersensitivity (for example fever, lymphadenopathy) may be present even though rash is not evident.
Hvis sådanne tegn og symptomer opstår, skal patienten straks undersøges, og behandlingen med Lamictal skal seponeres, hvis der ikke kan etableres en alternativ ætiologi.
If such signs and symptoms are present the patient should be evaluated immediately and Lamictal discontinued if an alternative aetiology cannot be established.
58 Klinisk forværring og selvmordsrisiko forbundet med bipolar sygdom
57 Clinical worsening and suicide risk
Forekomst af selvmordstanker og - adfærd (suicidalitet) er blevet set hos patienter i behandling med antiepileptika for flere indikationer, herunder epilepsi og bipolar sygdom.
Suicidal ideation and behaviours (suicidality) have been reported in patients treated with AEDs in several indications, including epilepsy and bipolar disorder.
En meta- analyse af placebo - kontrolleret forsøg af antiepileptika (herunder lamotrigin) viste en forhøjet risiko for selvmordsadfærd (se pkt.
A meta-analysis of placebo-controlled trials of AEDs (including lamotrigine) showed an increased risk of suicidal behaviour (see section 5.1).
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.
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.
Dette især ved opstart af behandlingen eller ved dosisskift.
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.
Disse patienter skal derfor overvåges nøje under behandlingen.
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.
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.
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.
4. 5).
Effects of hormonal contraceptives on lamotrigine efficacy 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 (see section 4.5).
En reduktion i lamotrigin- niveauerne er blevet forbundet med en dårligere kontrol af anfald.
A decrease in lamotrigine levels has been associated with loss of seizure control.
Stigninger i lamotrigin- koncentrationerne kan være forbundet med dosisrelaterede bivirkninger.
Increases in lamotrigine concentrations may be associated with dose-related adverse events.
4. 2).
In women not already taking an inducer of lamotrigine glucuronidation and taking a hormonal contraceptive that includes one week of inactive treatment (for example "pill-free week"), gradual transient increases in lamotrigine levels will occur during the week of inactive treatment (see section 4.2).
Variationer i lamotrigin- niveauerne af denne størrelsesorden kan være forbundet med bivirkninger.
Variations in lamotrigine levels of this order may be associated with adverse effects.
Det skal derfor overvejes at bruge kontraceptiva uden en pillefri uge som førstevalgsbehandling (for eksempel kontinuerlige hormonale kontraceptiva eller ikke- hormonale metoder).
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).
Disse kan dog have en lignende effekt på lamotrigins farmakokinetiske parametre.
The interaction between other oral contraceptive or HRT treatments and lamotrigine have not been studied, though they may similarly affect lamotrigine pharmacokinetic parameters.
4. 5).
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).
Derfor skal patienterne rådes til straks at søge læge ved ændringer i deres menstruationsmønster, dvs. gennembrudsblødning.
Therefore patients should be instructed to promptly report changes in their menstrual pattern, i. e. breakthrough bleeding.
59 Dihydrofolatreduktase
58 Dihydrofolate reductase
4. 6).
Lamotrigine has a slight inhibitory effect on dihydrofolic acid reductase, hence there is a possibility of interference with folate metabolism during long-term therapy (see section 4.6).
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.
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.
25, 50, 100 og 200 mg tabletter:
25, 50, 100 and 200 mg tablets:
Hjælpestof i Lamictal- tabletter
Excipient of Lamictal tablets
Lamictal- tabletter indeholder lactosemonohydrat.
Lamictal tablets contain lactose monohydrate.
Dette lægemiddel må ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel (Lapp Lactase Deficiency) eller glucose - / galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pludselig seponering af Lamictal kan, som det også er tilfældet med andre antiepileptika, fremprovokere rebound- krampeanfald.
As with other AEDs, abrupt withdrawal of Lamictal may provoke rebound seizures.
Medmindre der kræves øjeblikkelig seponering af sikkerhedsmæssige årsager (f. eks. udslæt), skal dosis af Lamictal reduceres gradvist over en periode på to uger.
Unless safety concerns (for example rash) require an abrupt withdrawal, the dose of Lamictal should be gradually decreased over a period of two weeks.
I data foreslås det, at respons i forbindelse med enzym induktorer er mindre end i forbindelse med ikke- enzym inducerende antiepileptiske midler.
There is a suggestion in the data that responses in combination with enzyme inducers is less than in combination with non-enzyme inducing antiepileptic agents.
60 Forsigtighedsregler i forbindelse med bipolar sygdom
59 Precautions relating to bipolar disorder
Børn og unge under 18 år Behandling med antidepressiva er forbundet med en øget risiko for selvmordstanker og - adfærd hos børn og unge med alvorlige depressioner og andre psykiske forstyrrelser.
Children and adolescents below 18 years 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.
Lamotrigin metaboliseres af enzymerne UDP- glukuronyltransferaser.
UDP-glucuronyl transferases have been identified as the enzymes responsible for metabolism of lamotrigine.
Der er ingen tegn på, at lamotrigin forårsager en klinisk signifikant induktion eller hæmning af oxidative lægemiddelmetaboliserende leverenzymer, og det er usandsynligt, at der sker interaktioner mellem lamotrigin og lægemidler, som metaboliseres af cytokrom P450- enzymer.
There is no evidence that lamotrigine causes clinically significant induction or inhibition of hepatic oxidative drug-metabolising enzymes, and interactions between lamotrigine and medicinal products metabolised by cytochrome P450 enzymes are unlikely to occur.
Effekten af andre lægemidler på glukuronidering af lamotrigin
Effects of other medicinal products on glucuronidation of lamotrigine
Lægemidler, der signifikant Lægemidler, der signifikant
Medicinal products that Medicinal products that
hæmmer glukuronidering af lamotrigin
Medicinal products that do not
inducerer glukuronidering af lamotrigin
significantly inhibit glucuronidation of lamotrigine Valproate
Phenytoin Carbamazepin Phenobarbital Primidon Rifampicin Lopinavir/ ritonavir Kombination af ethinyløstradiol/ levonorgestrel *
significantly induce glucuronidation of lamotrigine Phenytoin Carbamazepine Phenobarbitone Primidone Rifampicin Lopinavir/ ritonavir Ethinyloestradiol/ levonorgestrel combination*
Oxcarbazepin Felbamat Gabapentin Levetiracetam Pregabalin Topiramat Zonisamid Lithium Bupropion Olanzapin
significantly inhibit or induce glucuronidation of lamotrigine Oxcarbazepine Felbamate Gabapentin Levetiracetam Pregabalin Topiramate Zonisamide Lithium Buproprion Olanzapine
4. 2 og 4. 4).
* Other oral contraceptive and HRT treatments have not been studied, though they may similarly affect lamotrigine pharmacokinetic parameters (see sections 4.2 and 4.4).
4. 2).
In patients receiving concomitant therapy with valproate, the appropriate treatment regimen should be used (see section 4.2).
4. 2).
In patients receiving concomitant therapy with phenytoin, carbamazepine, pheonbarbitone or primidone, the appropriate treatment regimen should be used (see section 4.2).
Der blev
These events usually resolve when the dose of carbamazepine is reduced.
61 observeret en lignende effekt i et forsøg med lamotrigin og oxcarbazepin hos raske frivillige voksne, men dosisreduktion blev ikke undersøgt.
A similar effect was seen during a study of lamotrigine and oxcarbazepine in healthy adult volunteers, but dose reduction was not investigated.
I et prospektivt forsøg, hvor raske frivillige voksne fik doser på 200 mg lamotrigin og 1. 200 mg oxcarbazepin, ændrede oxcarbazepin ikke metaboliseringen af lamotrigin, og lamotrigin ændrede ikke metaboliseringen af oxcarbazepin.
60 doses of 200 mg lamotrigine and 1200 mg oxcarbazepine, oxcarbazepine did not alter the metabolism of lamotrigine and lamotrigine did not alter the metabolism of oxcarbazepine.
4. 2).
Therefore in patients receiving concomitant therapy with oxcarbazepine, the treatment regimen for lamotrigine adjunctive therapy without valproate and without inducers of lamotrigine glucuronidation should be used (see section 4.2).
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.
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.
Administration af lamotrigin medførte en stigning i koncentrationen af topiramat på 15%.
Administration of lamotrigine resulted in a 15% increase in topiramate concentrations.
I et forsøg, hvor patienter med epilepsi fik både zonisamid (200 til 400 mg/ dag) og lamotrigin (150 til 500 mg/ dag) i 35 dage, havde den samtidige administration ingen signifikant effekt på lamotrigins farmakokinetik.
In a study of patients with epilepsy, coadministration of zonisamide (200 to 400 mg/ day) with lamotrigine (150 to 500 mg/ day) for 35 days had no significant effect on the pharmacokinetics of lamotrigine.
In vitro- forsøg indikerer, at lamotrigin ikke fortrænger andre antiepileptika fra proteinbindingsstederne.
Evidence from in vitro studies indicates that lamotrigine does not displace other AEDs from protein binding sites.
Lithiums farmakokinetik efter administration af 2 g vandfrit lithiumgluconat to gange dagligt i seks dage til 20 raske forsøgspersoner blev ikke ændret ved samtidig administration af 100 mg lamotrigin dagligt.
The pharmacokinetics of lithium after 2 g of anhydrous lithium gluconate given twice daily for six days to 20 healthy subjects were not altered by co-administration of 100 mg/ day lamotrigine.
I et forsøg med raske frivillige voksne medførte administration af 15 mg olanzapin en reduktion i AUC og Cmax af lamotrigin på gennemsnitligt henholdsvis 24% og 20%.
In a study in healthy adult volunteers, 15 mg olanzapine reduced the AUC and Cmax of lamotrigine by an average of 24% and 20%, respectively.