natgillin/translations-raw huggingface dataset:
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.
Omkring 30-40 % af de personer i de kliniske forsøg, som blev behandlet med retigabin, og som fik foretaget hudundersøgelse og/eller oftamologisk undersøgelse, havde misfarvning af negle, læber, hud og/eller slimhinder eller ikke-retinale pigmentforandringer i øjnene, og ca. 15-30 % af de personer i de kliniske forsøg, som blev behandlet med retigabin, og som fik foretaget en oftamologisk undersøgelse, havde retinale pigmentforandringer. 
Approximately 30-40% of clinical trial subjects who were being treated with retigabine and underwent a skin and/or ophthalmological examination had findings of discolouration of nails, lips, skin and/or mucosa or non-retinal ocular pigmentation, and approximately 15-30% of clinical trial subjects who were being treated with retigabine and underwent an ophthalmological examination had retinal pigmentation findings.
Uigennemsigtig PVC-PVDC-aluminiumsfolieblister. 
Opaque PVC-PVDC-aluminium foil blisters.
Retigabins fordelingsvolumen ved steady state er 2 til 3 l/kg efter intravenøs dosering. 
The steady state volume of distribution of retigabine is 2 to 3 l/kg following intravenous dosing.
Justering af digoxindosis er ikke nødvendig. 
No dose adjustment of digoxin is needed.
Dette stabiliserer membranens hvilepotentiale, og kontrollerer neuronets sub-threshold excitabilitet, så initiering af epileptiforme aktionspotentialer forhindres. 
This stabilises the resting membrane potential and controls the sub-threshold electrical excitability in neurons, thus preventing the initiation of epileptiform action potential bursts.
• Ordineringsvejledning til lægen. 
• A physician's guide to prescribing.
Inden for hver frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er. 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Du må ikke stoppe behandlingen uden først at have talt med lægen. 
Do not stop treatment without discussing it with your doctor.
Ved beslutning om, hvorvidt amningen skal fortsætte eller ophøre, eller behandling med Trobalt skal fortsætte eller ophøre, bør der tages højde for barnets fordel ved at blive ammet og moderens fordel ved behandling med Trobalt. 
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Trobalt should be made taking into account the benefit of breast-feeding to the child and the benefit of Trobalt therapy to the woman.
Når Trobalt seponeres, skal doseringen gradvist reduceres over en periode på mindst 3 uger (se pkt. 
When withdrawing Trobalt, the dose must be gradually reduced over a period of at least 3 weeks (see section 4.4).
Retigabin elimineres gennem en kombination af hepatisk metabolisering og renal udskillelse. 
Elimination of retigabine occurs via a combination of hepatic metabolism and renal excretion.
Mekanismen for denne risiko kendes ikke, og muligheden for en forøget risiko ved behandling med retigabin kan ikke udelukkes ud fra de foreliggende data. 
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for retigabine.
Hvis du har glemt at tage en dosis, skal du tage den, så snart du kommer i tanke om det. 
If you miss any doses, just take one dose as soon as you remember.
In vitro-studier indikerer, at retigabin primært virker ved at åbne neuronale kaliumkanaler af typen KCNQ2 [Kv7.2] og KCNQ3 [Kv7.3]. 
In vitro studies indicate that retigabine acts primarily through opening neuronal potassium channels (KCNQ2 [Kv7.2] and KCNQ3 [Kv7.3]).
Fortæl lægen, hvis du oplever synsforandringer, mens du er i behandling med Trobalt. 
Tell your doctor if you experience any changes in vision whilst you are being treated with Trobalt.
Den maksimale totale vedligeholdelsesdosis er 1.200 mg/dag. 
The maximum total maintenance dose is 1,200 mg/day.
Samtidig administration af ethanol (1,0 g/kg) og retigabin (200 mg) resulterede i en øget forekomst af tågesyn hos raske frivillige forsøgspersoner. 
Co-administration of ethanol (1.0 g/kg) with retigabine (200 mg) resulted in an increase in visual blurring in healthy volunteers.
Maksimumsdoser i toksicitetsstudier med gentagne doser var begrænsede af retigabins udtalte farmakologiske virkninger (herunder ataksi, hypokinesi og tremor). 
Maximum doses in repeat dose toxicity studies were limited by the exaggerated pharmacologic effects of retigabine (including ataxia, hypokinesia and tremor).
Yderligere viste denne analyse ingen klinisk signifikant påvirkning af induktorer (phenytoin, carbamazepin og phenobarbital) på retigabins clearance. 
This analysis also showed no clinically significant effect of the inducers (phenytoin, carbamazepine and phenobarbital) on retigabine clearance.
Hypokinesi 
Hypokinesia
Psykotiske forstyrrelser Hallucinationer Desorientering 
Confusional state Psychotic disorders Hallucinations Disorientation Anxiety
Det er vist, at retigabin interagerer med laboratorieanalyser af både serum- og urinbilirubin, hvilket kan resultere i falsk forhøjede værdier. 
Retigabine has been shown to interfere with clinical laboratory assays of both serum and urine bilirubin, which can result in falsely elevated readings.
Pædiatrisk population Retigabins farmakokinetik er ikke undersøgt hos børn under 12 år. 
Paediatric population The pharmacokinetics of retigabine in children below 12 years of age have not been investigated.
Nedsat nyrefunktion Retigabin og dets metabolitter elimineres primært via renal udskillelse. 
Retigabine and its metabolites are eliminated principally by renal excretion.
Størstedelen af hændelserne opstod i de første 8 uger af behandlingen, og der var ingen klar sammenhæng med dosis. 
The majority of events occurred in the first 8 weeks of treatment, and there was no apparent dose-relationship.
Trobalt 50 mg filmovertrukne tabletter Trobalt 100 mg filmovertrukne tabletter Trobalt 200 mg filmovertrukne tabletter Trobalt 300 mg filmovertrukne tabletter Trobalt 400 mg filmovertrukne tabletter 
Trobalt 50 mg film-coated tablets Trobalt 100 mg film-coated tablets Trobalt 200 mg film-coated tablets Trobalt 300 mg film-coated tablets Trobalt 400 mg film-coated tablets
Trobalt skal anvendes med forsigtighed til denne population og det anbefales at reducere start- og vedligeholdelsesdosis (se pkt. 
Trobalt must be used with caution in this population and a reduced initial and maintenance dose is recommended (see sections 4.2 and 5.2).
Denne stigning anses imidlertid ikke for at have klinisk betydning, og da retigabin titreres i henhold til den enkelte patients respons og tolerance, er det ikke nødvendigt at foretage dosisjusteringer på grundlag af legemsvægten. 
However, this increase is not considered to be clinically meaningful, and since retigabine is titrated according to individual patient response and tolerability, dose-adjustments are not required on the basis of body weight.
Trobalt skal seponeres gradvist for at minimere risikoen for anfald som følge af seponeringen. 
Trobalt must be withdrawn gradually to minimise the potential for rebound seizures.
I et kardielt overledningsstudie hos raske forsøgspersoner blev det påvist, at retigabin titreret til 1.200 mg/dag medførte en forlængelse af QT-intervallet. 
A study of cardiac conduction in healthy subjects has demonstrated that retigabine titrated to 1,200 mg/day produced a QT-prolonging effect.
I en række epilepsimodeller hævede retigabin tærsklen for induktion af anfald fremkaldt af maksimalt elektrochok, pentylentetrazol, picrotoxin og N-methyl-D-aspartat (NMDA). 
In a range of seizure models, retigabine increased the threshold for seizure induction produced by maximal electroshock, pentylenetetrazol, picrotoxin and N-methyl-D-aspartate (NMDA).
Blågrå misfarvning af hud, læber eller negle: dette er meget almindeligt hos personer, der har taget Trobalt i flere år. 
A blue-grey discolouration of the skin, lips or nails: this is very common in people taking Trobalt for several years.
Tabel 1 Oversigt over procentvise ændringer i den samlede frekvens af partielle anfald i løbet af 28 dage og respondentrater 
Summary of percentage changes in 28-day total partial seizure frequency and responder rates
Det anbefales, at dosis af Trobalt reduceres over en periode på mindst 3 uger, medmindre der af sikkerhedsmæssige årsager kræves en øjeblikkelig seponering (se pkt. 
It is recommended that the Trobalt dose is reduced over a period of at least 3 weeks, unless safety concerns require an abrupt withdrawal (see section 4.2).
Det vides ikke, om retigabin udskilles i human mælk. 
It is unknown whether retigabine is excreted in human breast milk.
Øvrige indholdsstoffer: croscarmellosenatrium, hypromellose, magnesiumstearat, mikrokrystallinsk cellulose, polyvinylalkohol, titandioxid (E171), talcum (E553b), lecithin (soja) og xanthangummi. 
The other ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide (E171) , talc (E553b), Lecithin (SOY) and Xanthan gum.
Retigabin metaboliseres i udtalt grad hos mennesker. 
Retigabine is extensively metabolised in humans.
Balanceforstyrrelser Hukommelsesbesvær Dysfasi 
Balance disorder Memory impairment
I et andet studie med enkeltdoser hos personer med nyresygdom i slutstadiet, der fik vedvarende hæmodialyse (n=8), resulterede initiering af dialyse ca. fire timer efter en enkelt dosis retigabin (100 mg) i en gennemsnitlig reduktion af retigabins plasmakoncentration på 52 % fra starten til slutningen af dialysen. 
In a second single-dose study in subjects with end stage renal disease receiving chronic haemodialysis (n= 8), initiation of dialysis at approximately 4 hours after a single dose of retigabine (100 mg) resulted in a median reduction in retigabine plasma concentrations of 52% from the start to end of dialysis.
Data fra ældre patienter indikerer, at de har højere risiko for at opleve bivirkninger i centralnervesystemet, herunder somnolens, amnesi, abnormal koordination, vertigo, tremor, balanceforstyrrelser, påvirket hukommelse og gangforstyrrelse. 
Data from elderly patients indicates that they may be more likely to experience certain central nervous system events, including somnolence, amnesia, coordination abnormal, vertigo, tremor, balance disorder, memory impairment and gait disturbance.
Effekten af retigabin på fertiliteten hos mennesker er ikke fastlagt. 
The effect of retigabine on human fertility has not been established.
Det fungerer ved at forhindre den hjerneaktivitet, der forårsager epileptiske anfald (krampeanfald). 
It works by preventing the brain overactivity that causes epileptic seizures (also called fits).
Resultaterne af et studie med enkeltdoser viste, at Cmax for retigabin hos unge voksne frivillige forsøgspersoner var ca. 65 % højere hos kvinder end hos mænd, og hos ældre frivillige forsøgspersoner (66-82 år) var Cmax for retigabin ca. 75 % højere hos kvinder end hos mænd. 
The results of a single-dose study showed that in young adult volunteers, retigabine Cmax was approximately 65% higher in females than in males, and in elderly volunteers (66 to 82 years of age), retigabine Cmax was approximately 75% higher in females compared with males.
Trobalt kan derfor tages med eller uden mad. 
Therefore Trobalt may be taken with or without food.
Disse er almindelige hos personer, der tager Trobalt, og forekommer oftest i løbet af de første få måneders behandling. 
Mental health problems These are common in people taking Trobalt, and are most likely to happen during the first few months of treatment.
Det blev i en post hoc-analyse på tværs af flere studier hos raske frivillige forsøgspersoner påvist, at der var en reduktion på 20 % i clearance for retigabin hos raske sorte frivillige forsøgspersoner i forhold til hos raske kaukasiske frivillige forsøgspersoner. 
A post-hoc analysis across multiple healthy volunteer studies demonstrated a 20% reduction in retigabine clearance in healthy black volunteers relative to healthy Caucasian volunteers.
Tag pakningen med, hvis det er muligt. 
If possible, show them the medicine pack.
I et studie med enkeltdoser var der ingen klinisk signifikante effekter på AUC for retigabin hos frivillige forsøgspersoner med let nedsat leverfunktion (Child-Pugh-score på 5 til 6). 
In a single-dose study, there were no clinically significant effects on retigabine AUC in volunteers with mild hepatic impairment (Child-Pugh score 5 to 6).
Vandladningsproblemer Disse er almindelige hos personer, der tager Trobalt, og kan medføre, at det slet ikke er muligt at lade vandet. 
These are common in people taking Trobalt, and can lead to not being able to pass urine at all.
Ved dosisniveauer, hvor ingen effekt har kunnet observeres, var eksponeringen hos dyr i disse studier generelt lavere end den eksponering, der ses hos mennesker ved de anbefalede kliniske doser. 
At no observed effect levels, animal exposure in these studies was generally less than that reached in humans at recommended clinical doses.
I et studie vedrørende udviklingen hos rotter, hvis mødre blev behandlet med retigabin i drægtighedsperioden, var der en forsinket udvikling af afkommets startle response (se pkt. 
In a developmental study in rats whose mothers were treated with retigabine during pregnancy, there was a delay in auditory startle response development of the offspring (see section 5.3).
Misfarvning af hud, negle, læber og øjne samt øjensygdom forårsaget af ændring i nethindens centrum (maculopati) 
Discolouration of skin, nails, lips and eyes, and eye disorders caused by changes in the centre of the retina (maculopathy)
Tabel over bivirkninger Der er benyttet følgende konvention til klassificering af bivirkninger: 
The following convention has been used for the classification of adverse reactions:
Erhvervet vitelliform 
Acquired Vitelliform
Der er ingen tegn på en hepatisk oxidativ metabolisering af retigabin eller NAMR forårsaget af cytochrom P450-enzymer. 
There is no evidence for hepatic oxidative metabolism of retigabine or NAMR by cytochrome P450 enzymes.
• påvirket hjerterytme. 
• effects on heart rhythm.
Ældre patienter kan have en forøget risiko for bivirkninger i centralnervesystemet, urinretention, samt atrieflimren. 
Elderly patients may be at increased risk of central nervous system events, urinary retention and atrial fibrillation.
Øjensygdomme, forårsaget af ændringer i nethindens centrum (maculopati): dette kan være almindeligt hos personer ,der tager Trobalt. 
Eye disorders caused by changes in the centre of the retina (maculopathy): this can be common in people taking Trobalt.
Brug af Trobalt sammen med alkohol 
Trobalt with alcohol
Kontakt lægen, skadestuen eller apoteket, hvis du har taget mere Trobalt, end lægen har foreskrevet. 
Contact your doctor or pharmacist for advice if you ever take more Trobalt than you are prescribed.
Den totale daglige startdosis er 150 mg, og det anbefales, at den totale daglige dosis i titreringsperioden øges med 50 mg hver uge til en maksimal total dosis på 600 mg/dag. 
The total daily starting dose is 150 mg, and it is recommended that during the titration period, the total daily dose is increased by 50 mg every week, to a maximum total dose of 600 mg/day.
Disse kan forekomme hos op til 1 ud af 100 personer: 
These may affect up to 1 in 10 people:
Der var en tilsyneladende sammenhæng mellem dosis og graden af svimmelhed, døsighed, konfusion, afasi, koordinationsbesvær, tremor, balanceforstyrrelser, hukommelsesbesvær, gangforstyrrelser, tågesyn og obstipation. 
There was an apparent dose-relationship for dizziness, somnolence, confusional state, aphasia, coordination abnormal, tremor, balance disorder, memory impairment, gait disturbance, blurred vision and constipation.
De primære effekt endepunkter var: - den procentvise ændring i den samlede frekvens af partielle anfald i løbet af 28 dage fra baseline til den dobbeltblindede fase (titrerings- og vedligeholdelsesfasen kombineret) i alle tre studier - respondentraten (defineret som procentdel af patienter med en reduktion på ≥ 50 % i den samlede frekvens af partielle anfald i løbet af 28 dage) fra baseline til vedligeholdelsesfasen 
The primary efficacy endpoints were: - percentage change in the 28-day total partial seizure frequency from baseline to the double-blind phase (titration and maintenance phases combined) in all three studies - responder rate (defined as the percentage of patients with a ≥50% reduction in 28-day total partial seizure frequency) from baseline to the maintenance phase (Studies 301 and 302 only).
Del af en multipakning, kan ikke sælges enkeltvis 
84 film-coated tablets Component of a multipack, can't be sold separately
Forhøjede værdier ved leverfunktionsundersøgelser 
Increased liver function tests
Dyrestudier er ikke tilstrækkelige, hvad angår reproduktionstoksicitet, da plasmaniveauerne, der blev opnået i disse studier, var lavere end de niveauer, der blev set hos mennesker ved de anbefalede doser (se pkt. 
Animal studies are insufficient with respect to reproductive toxicity because the plasma levels achieved in these studies were less than those reached in humans at recommended doses (see section 5.3).
I et studie med enkeltdoser blev retigabin elimineret langsommere af raske ældre frivillige forsøgspersoner (66-82 år) end af raske unge voksne frivillige forsøgspersoner, hvilket resulterede i et større AUC (ca. 40-50 %) og en længere terminal halveringstid (30 %) (se pkt. 
In a single-dose study, retigabine was eliminated more slowly by healthy elderly volunteers (66 to 82 years of age) relative to healthy young adult volunteers, resulting in a higher AUC (approximately 40 to 50%) and longer terminal half-life (30%) (see section 4.2).
Reversibilitet af pigmentforandringer i øjenvæv efter seponering af retigabin har været rapporteret hos nogle personer. 
Reversibility of retinal pigmentation after retigabine discontinuation has been reported in some subjects.
Hud og subkutane væv 
Skin and subcutaneous disorders
Derfor er det usandsynligt, at retigabin vil påvirke farmakokinetikken af substrater af de primære cytochrom P450isoenzymer gennem hæmnings- eller induktionsmekanismer. 
Therefore, retigabine is unlikely to affect the pharmacokinetics of substrates of the major cytochrome P450 isoenzymes through inhibition or induction mechanisms.
Trobalt kan tages med eller uden mad. 
You can take Trobalt with or without food.
Doser på mere end 900 mg/dag anbefales ikke (se pkt. 
Doses greater than 900 mg/day are not recommended (see sections 4.4 and 5.2).
Plasmaniveauerne, der blev opnået i disse studier, var imidlertid lavere end de niveauer, der blev set hos mennesker ved de anbefalede doser (se pkt. 
However, the plasma levels achieved in these studies were less than those reached in humans at recommended doses (see section 5.3).
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/. 
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Det skal du vide, før du begynder at tage Trobalt 
What you need to know before you take Trobalt
Misfarvning af dele af øjet, herunder nethinden (i den bageste del af øjet): dette kan være meget almindeligt hos personer, der har taget Trobalt i flere år. 
Discolouration of parts of the eye, including the retina (inside the back of the eye): this can be very common in people taking Trobalt for several years.
Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis. 
Don't take more than one dose at a time to make up for missed doses.
Der blev rapporteret bivirkninger relateret til vandladningsproblemer, herunder urinretention, hos 5 % af de patienter, som blev behandlet med retigabin, i det samlede sikkerhedsdatasæt (se pkt. 
Adverse reactions related to voiding dysfunction, including urinary retention, were reported in 5% of retigabine-treated patients in the pooled safety dataset (see section 4.4).