natgillin/translations-raw huggingface dataset:
Tabletterne skal synkes hele og må ikke tygges, knuses eller brækkes over.
The tablets should be swallowed whole, and not chewed, crushed or divided.
Trobalt er til oral anvendelse.
Trobalt is for oral use.
* Statistisk signifikant, p ≤ 0,05.
* Statistically significant, p≤0.05 ~ Dose not studied
Fortæl det til lægen, hvis noget af ovenstående gælder for dig.
Tell your doctor if any of these applies to you.
Derudover var der en forsinket udvikling af afkommets startle response.
In addition, there was a delay in auditory startle response development.
C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
C OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Retigabin har en plasmahalveringstid på ca. 6-10 timer.
Retigabine has a plasma half-life of approximately 6 to 10 hours.
Hvis du har glemt at tage Trobalt
If you forget to take Trobalt
Symptomer og tegn Der er begrænset erfaring med overdosering af retigabin.
Symptoms and signs There is limited experience of overdose with retigabine.
Derudover er der identificeret tilfælde af erhvervet maculopati af vitelliformtypen, både i kliniske studier og som spontane indberetninger.
In addition, cases of acquired vitelliform-type maculopathy have been identified, both in clinical studies and as spontaneous reports.
Orale kontraceptiva
Oral contraceptives
• manglende evne til at lade vandet (urinretention).
• not being able to pass urine (urinary retention).
Retigabin metaboliseres desuden til en N-acetyl-metabolit (NAMR), som også efterfølgende glucuroniseres.
Retigabine is also metabolised to an N-acetyl metabolite (NAMR) that is also subsequently glucuronidated.
Efter både enkeltdoser og gentagne doser administreret oralt absorberes retigabin hurtigt med medianværdier af tmax generelt på mellem 0,5 og 2 timer.
After both single and multiple oral doses, retigabine is rapidly absorbed with median tmax values generally between 0.5 and 2 hours.
Du må ikke tage mere Trobalt, end lægen har foreskrevet.
Don't take any more Trobalt than your doctor has recommended.
I alt ca. 84 % af dosis genfindes i urinen, herunder N-acetyl-metabolitten (18 %), N-glucuronider af det aktive stof og af N-acetyl-metabolitten (24 %) eller uomdannet aktivt stof (36 %).
A total of approximately 84% of the dose is recovered in the urine, including the N-acetyl metabolite (18%), N-glucuronides of the parent active substance and of the N-acetyl metabolite (24%), or parent active substance (36%).
Usikkerheden omkring betydningen af denne risiko for patienterne vedbliver, da der er risiko for funktionelle abnormaliteter forbundet med retinopati, herunder mulig alvorlig synsnedsættelse.
Uncertainties about the impact of this risk on patients remain as there is a possibility of functional abnormalities associated with retinopathy including potentially severe visual impairment.
• prikken eller følelsesløshed i hænderne eller fødderne
• tingling or numbness of the hands or feet
Retigabins virkning og sikkerhed er imidlertid ikke klarlagt hos unge.
However, efficacy and safety of retigabine have not been determined in adolescents.
Kun 14 % af retigabindosis udskilles i fæces.
Only 14% of retigabine is excreted in the faeces.
Trobalt anbefales ikke under graviditet og til kvinder i den fødedygtige alder, der ikke anvender prævention.
Trobalt is not recommended during pregnancy and in women of childbearing age, not using contraception.
Det anvendes sammen med andre antiepileptiske lægemidler til behandling af voksne, der fortsat oplever anfald og hvor andre kombinationer af antiepileptisk medicin ikke har tilstrækkelig virkning.
It is used together with other anti-epileptic medicines to treat adults who continue to experience seizures and where other combinations of antiepileptic medicines have not worked well.
Der var ingen klinisk relevant ændring i digoxins Cmax.
There was no meaningful change in digoxin Cmax.
Du må ikke holde op med at tage Trobalt uden rådgivning Du skal tage Trobalt i så lang tid, som lægen foreskriver.
Don't stop taking Trobalt without advice Take Trobalt for as long as your doctor recommends.
Meget almindelig: ≥ 1/10
Very common: ≥1/10 Common:
Hos patienter med terminal nyreinsufficiens i hæmodialyse skal de tre daglige doser tages som sædvanligt på dialysedagen.
For patients with end-stage renal disease receiving haemodialysis, the three daily doses should be taken as usual on the dialysis day.
Retigabin var effektiv som tillægsbehandling hos voksne med partielle anfald i tre kliniske studier (tabel 1).
Retigabine was effective in adjunctive treatment of adults with partial onset seizures in three clinical studies (Table 1).
Der blev observeret udspiling af galdeblæren i studier af hunde, men der blev ikke set kolestase eller andre tegn på dysfunktion af galdeblæren, og udstrømningsvolumenet af galde var uændret.
Distension of the gall bladder was seen in studies with dogs, but there was no evidence of cholestasis or other signs of gall bladder dysfunction, and bile ejection volume was unchanged.
Der er indberettet selvmordstanker og selvmordsadfærd hos patienter, som er blevet behandlet med antiepileptika ved flere indikationer.
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Mekanismen for retigabins virkning på kaliumkanaler er veldokumenteret, mens andre af retigabins mekanismer, som eventuelt kan have en antiepileptisk effekt endnu ikke er fuldt belyst.
The mechanism of action of retigabine on potassium channels has been well documented, however other mechanisms by which retigabine may assert an antiepileptic effect have yet to be fully elucidated.
Derudover inducerede retigabin og NAMR ikke CYP 1A2 eller CYP 3A4/5 i humane primære hepatocytter.
In addition, retigabine and NAMR did not induce CYP1A2 or CYP3A4/5 in human primary hepatocytes.
Når en oversprungen dosis er taget, skal der gå mindst 3 timer, før den næste dosis tages, og herefter skal den sædvanlige doseringsplan igen følges.
After taking a missed dose, at least 3 hours should be allowed before the next dose and then the normal dosing schedule should be resumed.
Hver tablet indeholder 50 mg, 100 mg, 200 mg, 300 mg eller 400 mg retigabin.
Each tablet contains 50 mg, 100 mg, 200 mg, 300 mg or 400 mg retigabine.
Retigabin havde ingen effekt på fertiliteten eller den generelle reproduktionsevne.
Retigabine had no effect on fertility or general reproductive performance.
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.
In women being treated for epilepsy, sudden discontinuation of antiepileptic medicine therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Fortæl det til lægen, at du tager Trobalt, og sig det i god tid i forvejen.
Tell the doctor that you are taking Trobalt, well in advance.
Farmakoterapeutisk klassifikation: Antiepileptika, andre antiepileptika, ATC-kode: N03AX21.
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX21.
I tilfælde af overdosering anbefales det, at patienten får en passende understøttende behandling, som klinisk indiceret, herunder overvågning med ekg-optagelser.
In the event of overdose, it is recommended that the patient is given appropriate supportive therapy as clinically indicated, including electrocardiogram (ECG) monitoring.
Trobalt indeholder det aktive stof retigabin.
Trobalt contains the active substance retigabine.
• blod i urinen, urin med unormal farve
• blood in the urine; abnormally coloured urine
Lægen vil holde tættere øje med dig, hvis behandlingen med Trobalt fortsættes.
Your doctor will monitor you more closely if treatment with Trobalt is continued.
Patienter (og pårørende samt plejepersonale) bør rådgives til at søge lægehjælp, hvis der opstår tegn på selvmordstanker og selvmordsadfærd.
Patients (and caregivers of patients) should be advised to seek medical advice if signs of suicidal ideation or behaviour emerge.
Administration af retigabin sammen med et måltid med et højt fedtindhold resulterede ikke i ændring i det samlede omfang af absorption af retigabin, men mad reducerede between-subject variability i Cmax (23 %) sammenlignet med fastende tilstand (41 %) og medførte en stigning i Cmax (38 %).
Administration of retigabine with a high fat meal resulted in no change in the overall extent of retigabine absorption, but food reduced the between-subject variability in Cmax (23%) compared to the fasted state (41%), and led to an increase in Cmax (38%).
Risici ved Trobalt
Risk related to Trobalt
Der foreligger ikke tilstrækkelige data fra anvendelse af retigabin til gravide kvinder.
There are no adequate data from the use of retigabine in pregnant women.
Hvis du skal opereres under fuld bedøvelse:
If you are going to have an operation under a general anaesthetic:
• hvis du har et lavt niveau af kalium (hypokaliæmi) eller magnesium (hypomagnesiæmi) i blodet
• if you have an existing heart problem • if you have low potassium (hypokalaemia) or low magnesium (hypomagnesaemia) in your
I et studie, hvor den peri- og postnatale udvikling hos rotter blev undersøgt, blev retigabin forbundet med en øget perinatal mortalitet efter administration i drægtighedsperioden.
In a study of peri- and post-natal development in rats, retigabine was associated with increased perinatal mortality following administration during pregnancy.
Tal med lægen om, hvordan din epilepsi påvirker din evne til at føre motorkøretøj og arbejde med maskiner.
You must talk to your doctor about the effect of your epilepsy on driving and using machines.
Udspilingen af galdeblæren hos hunden resulterede i fokal sammenpresning af leveren.
The gall bladder distension in the dog resulted in focal compression of the liver.
Behandling med flere antiepileptika er forbundet med en højere risiko for medfødte misdannelser end monoterapi, og derfor bør monoterapi altid benyttes, når det er muligt.
Therapy with multiple antiepileptic medicinal products is associated with a higher risk of congenital malformations than monotherapy and therefore monotherapy should be used whenever possible.
I en populationsfarmakokinetisk analyse steg clearance for retigabin med stigende kropsoverfladeareal.
In a population pharmacokinetic analysis, retigabine clearance increased with increasing body surface area.
Det anbefales, at patienter informeres om risikoen for sådanne bivirkninger i starten af behandlingsforløbet og efter hvert titreringstrin, samt at de instrueres i ikke at føre motorkøretøj og betjene maskiner, før de ved, hvordan Trobalt påvirker dem.
It is recommended that patients are advised about the risk of such adverse reactions at treatment initiation and following each titration step, and that they are advised not to drive or operate machinery until they have established how Trobalt affects them.
Trobalt er indiceret som tillægsbehandling ved lægemiddelresistente partielle epileptiske anfald med eller uden sekundær generalisering hos voksne i alderen 18 år og derover, hvor andre passende kombinationer med andre lægemidler har vist sig utilstrækkelige eller ikke tåles.
Trobalt is indicated as adjunctive treatment of drug-resistant partial onset seizures with or without secondary generalization in patients aged 18 years or older with epilepsy, where other appropriate combinations with other medicinal products have proved inadequate or have not been tolerated.
Øjensygdomme er set ved brug af Trobalt, herunder pigmentændringer i retina.
Eye disorders have been observed with the use of Trobalt, including pigment changes in the retina.
Patienterne havde på tværs af alle studierne haft epilepsi i gennemsnitligt 22 år og en medianfrekvens af anfald ved baseline på 8-12 pr. 28 dage.
Across all studies, patients had a mean duration of epilepsy of 22 years and a median baseline seizure frequency ranging from 8 to 12 per 28 days.
Mutationer i KCNQ-kanalerne ligger til grund for flere arvelige forstyrrelser hos mennesker, herunder epilepsi (KCNQ2 og KCNQ3).
Mutations in the KCNQ channels underlie several human inheritable disorders, including epilepsy (KCNQ2 and 3).
Fortæl det hurtigst muligt til lægen, hvis du får et eller flere af disse symptomer.
Tell your doctor as soon as possible if you get any of these symptoms.
Data fra et in vitro-studie viste, at N-acetyl-metabolitten af retigabin (NAMR) hæmmede den Pglycoprotein-medierede transport af digoxin på en koncentrationsafhængig måde.
Data from an in vitro study showed that the N-acetyl metabolite of retigabine (NAMR) inhibited P-glycoprotein-mediated transport of digoxin in a concentration-dependent manner.
Sammenlagte sikkerhedsdata fra tre randomiserede, dobbeltblindede, placebokontrollerede multicenterstudier viste, at bivirkningerne generelt var milde til moderate i intensitet og hyppigst blev rapporteret i de første 8 uger af behandlingen.
In pooled safety data from three multicentre, randomised, double-blind, placebo-controlled studies, adverse reactions were generally mild to moderate in intensity, and were most commonly reported in the first 8 weeks of treatment.
6.6 Regler for destruktion Ingen særlige forholdsregler.
6.6 Special precautions for disposal No special requirements.
Fødepåvirkning af Cmax under sædvanlige kliniske forhold anses ikke for at være klinisk relevant.
The effect of food on Cmax under usual clinical conditions is not expected to be clinically relevant.
Den absolutte biotilgængelighed af oralt administreret retigabin i forhold til intravenøs dosering er ca. 60 %.
Absolute oral bioavailability of retigabine relative to an intravenous dose is approximately 60%.
Farmakokinetikken for retigabin er essentielt lineær over enkeltdosis-intervallet fra 25 til 600 mg hos raske frivillige forsøgspersoner og op til 1.200 mg daglig hos patienter med epilepsi, og der er ingen uventet akkumulation efter gentagen administration.
Retigabine pharmacokinetics are essentially linear over the single-dose range of 25 to 600 mg in healthy volunteers and up to 1,200 mg daily in patients with epilepsy, with no unexpected accumulation following repeated administration.
Synsabnormaliteter (begrænsning i synsfelt, tab af central følsomhed og nedsat synsskarphed) er rapporteret.
Vision abnormalities (field constriction, loss of central sensitivity, and reduced visual acuity) have been reported.
Et åbent, multidosis, farmakokinetisk sikkerheds- og tolerabilitetsstudie hos fem forsøgspersoner i alderen fra 12 år til under 18 år med partielle epileptiske anfald påviste, at retigabins farmakokinetik hos unge var sammenlignelig med farmakokinetikken hos voksne.
An open-label, multiple dose pharmacokinetic, safety and tolerability study in five subjects aged between 12 years to less than 18 years with partial onset seizures determined that the pharmacokinetics of retigabine in adolescents were consistent with the pharmacokinetics of retigabine in adults.
Retigabin var statistisk signifikant bedre end placebo, ved dosis på 600 mg/dag (ét studie), 900 mg/dag (to studier) og 1.200 mg/dag (to studier).
Retigabine was statistically significantly superior to placebo at 600 mg/day (one study), 900 mg/day (two studies) and 1,200 mg/day (two studies).
Der var dog ingen klar forskel i den vægt-normaliserede clearance mellem kønnene, og da retigabin titreres i henhold til den enkelte patients respons og tolerance, er det ikke nødvendigt at foretage dosisjusteringer på grundlag af kønnet.
However, there was no apparent gender difference in weight-normalized clearance, and since retigabine is titrated according to individual patient response and tolerability, dose-adjustments are not required on the basis of gender.
I det samlede datasæt over patienter, der blev behandlet med retigabin, blev der rapporteret om konfusion hos 9 % af patienterne, hallucinationer hos 2 % af patienterne og psykotiske forstyrrelser hos 1 % af patienterne (se pkt.
In retigabine-treated patients in the pooled dataset, confusional state was reported in 9% of patients, hallucinations in 2% of patients and psychotic disorders in 1% of patients (see section 4.4).
Meget almindelige bivirkninger Disse kan forekomme hos flere end 1 ud af 10 personer:
Very common side effects These may affect more than 1 in 10 people:
En gennemsnitlig stigning af Individual Corrected QT Interval (QTcl) på op til 6,7 ms (øvre grænse for 95 % ensidet konfidensinterval var 12,6 ms) blev observeret inden for 3 timer efter dosering.
A mean increase in Individual Corrected QT Interval (QTcI) of up to 6.7 ms (upper bound of 95% one-sided CI 12.6 ms) was observed within 3 hours of dosing.
Retigabins sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt (se pkt.
The safety and efficacy of retigabine in children below 18 years of age has not yet been established (see section 5.2).
Sikkerheden og virkningen af doser højere end 1.200 mg/dag er ikke fastlagt.
The safety and efficacy of doses higher than 1,200 mg/day have not been established.
Den totale clearance af retigabin fra plasma efter intravenøs dosering er typisk 0,4-0,6 l/t./kg.
The total clearance of retigabine from plasma following intravenous dosing is typically 0.4 to 0.6 l/h/kg.
Det anbefales, at patienter informeres om den mulige påvirkning af synet, hvis de drikker alkohol, mens de er i behandling med Trobalt.
It is recommended that patients are advised about the possible effects on vision if they take Trobalt with alcohol.
Der bør udvises forsigtighed ved ordinering af Trobalt sammen med lægemidler, som er kendt for at forlænge QT-intervallet, og hos patienter med kendt langt QT-interval, kongestiv hjerteinsufficiens, ventrikelhypertrofi, hypokaliæmi eller hypomagnesiæmi samt hos patienter, der er 65 år eller ældre.
Caution should be taken when Trobalt is prescribed with medicinal products known to increase QT interval and in patients with known prolonged QT interval, congestive cardiac failure, ventricular hypertrophy, hypokalaemia or hypomagnesaemia and in patients initiating treatment who are 65 years of age and above.
Hvis patienten, der udvikler disse forandringer, må behandling med Trobalt kun fortsættes efter en grundig reevaluering af fordele og risici.
In patients who develop these changes, treatment with Trobalt should only be continued after a careful re-assessment of the balance of benefits and risks.
Tag altid lægemidlet nøjagtigt efter lægens anvisning.
Always take this medicine exactly as your doctor has told you to.
Fortæl det straks til lægen, hvis du får et eller flere af disse symptomer.
Tell your doctor immediately if you get any of these symptoms.
Ud over de bivirkninger, der er set ved administration af terapeutiske doser, omfattede symptomerne på overdosering af retigabin agitation, aggressiv adfærd og irritabilitet.
In addition to adverse reactions seen at therapeutic doses, symptoms of retigabine overdose included agitation, aggressive behaviour and irritability.
Patienterne blev randomiseret til placebo eller doser af retigabin på 600, 900 eller 1.200 mg/dag (se tabel 1).
Patients were randomized to placebo or retigabine at 600, 900 or 1,200 mg/day (see Table 1).
Virkningen og sikkerheden af retigabin taget sammen med antiepileptika, som mindre ofte blev anvendt som baggrundsbehandling i de kliniske studier, herunder levetiracetam, er derfor ikke blevet påvist med sikkerhed.
Consequently, the efficacy and safety of retigabine when taken concomitantly with antiepileptic medicinal products that were less commonly used as background treatment in the clinical studies, including levetiracetam, has not been definitely shown.
Der blev ikke observeret teratogenicitet efter administration af retigabin til drægtige dyr i perioden med organogenese.
There was no evidence of teratogenicity following administration of retigabine to pregnant animals during the period of organogenesis.
Når det er relevant, skal uddannelsesmaterialet inkludere et følgebrev, der fremhæver de vigtigste ændringer.
When applicable, a cover letter highlighting the main changes should also be included as part of the educational materials.
Croscarmellosenatrium Hypromellose Magnesiumstearat Mikrokrystallinsk cellulose.
Croscarmellose sodium Hypromellose Magnesium stearate Microcrystalline cellulose.
Baseret på et studie med raske frivillige resulterede terapeutiske doser af retigabin (600-1.200 mg/dag) i en mindre (8-18%) stigning i digoxin-AUC efter en enkelt oral digoxindosis.
Based on a study conducted in healthy volunteers, therapeutic doses of retigabine (600-1,200 mg/day) resulted in a minor (8-18%) increase in digoxin AUC following a single oral dose of digoxin.
En metaanalyse af randomiserede, placebokontrollerede studier med antiepileptika har desuden vist, at der er en let forøget risiko for selvmordstanker og selvmordsadfærd.
A meta-analysis of randomised placebo-controlled trials of antiepileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the pack.
• rystelser/tremor, pludselige muskelsammentrækninger (myoclonus)
• tremors; sudden jerking of muscles (myoclonus)
Herefter øges den totale daglige dosis med maksimalt 150 mg hver uge alt efter den enkelte patients respons og tolerance.
Thereafter, the total daily dose is increased by a maximum of 150 mg every week, according to the individual patient response and tolerability.
De hyppigst indberettede misdannelser er læbespalte, kardiovaskulære misdannelser og neuralrørsdefekter.
The most frequently reported defects are cleft lip, cardiovascular malformations and neural tube defects.
En effektiv vedligeholdelsesdosis forventes at ligge mellem 600 mg/dag og 1.200 mg/dag.
An effective maintenance dose is expected to be between 600 mg/day and 1,200 mg/day.
In vitro-studier, hvor der blev anvendt humane levermikrosomer, viste, at retigabin havde et lille eller intet potentiale til at hæmme de primære cytochrom P450-isoenzymer (herunder CYP 1A2, CYP 2A6, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 og CYP 3A4/5).
In vitro studies using human liver microsomes showed little or no potential for retigabine to inhibit the major cytochrome P450 isoenzymes (including CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5).
Disse fund blev åbenlyse ved lavere eksponeringsniveau end dem, der blev opnået ved de anbefalede kliniske doser og var forbundet med maternal toksicitet (herunder ataksi, hypokinesi, tremor og reduceret øgning af kropsvægten).
These findings were apparent at exposure levels lower than those obtained with clinically recommended doses and were accompanied by maternal toxicities (including ataxia, hypokinesia, tremor and reduced body weight gain).
Hos rotter passerede retigabin og/eller dets metabolitter placenta, hvilket resulterede i vævskoncentrationer, der var af samme størrelsesorden hos moderdyrene og i fostrene.
In rats, retigabine and/or its metabolites crossed the placenta resulting in tissue concentrations that were similar in dams and foetuses.
Derudover forhindrede retigabin effektivt status epilepticusanfald hos gnavere med cobolt-inducerede epileptogene læsioner og hæmmede toniske anfald i ekstensorer hos genetisk disponerede mus.
In addition, retigabine was effective in preventing status epilepticus seizures in rodents with cobalt-induced epileptogenic lesions, and inhibiting tonic extensor seizures in genetically susceptible mice.
Disse bivirkninger forekom generelt inden for de første 8 uger af behandlingen og førte hyppigt til seponering af behandlingen hos de pågældende patienter.
These effects generally occurred within the first 8 weeks of treatment, and frequently led to treatment withdrawal in affected patients.
Dyrestudier har vist, at retigabin og/eller dets metabolitter udskilles i modermælken.
Animal studies have shown excretion of retagabine and/or its metabolites in breast milk.