FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric population The pharmacokinetics of retigabine in children below 12 years of age have not been investigated.
Danish: Pædiatrisk population Retigabins farmakokinetik er ikke undersøgt hos børn under 12 år.
English: Retigabine and its metabolites are eliminated principally by renal excretion.
Danish: Nedsat nyrefunktion Retigabin og dets metabolitter elimineres primært via renal udskillelse.
English: The majority of events occurred in the first 8 weeks of treatment, and there was no apparent dose-relationship.
Danish: Størstedelen af hændelserne opstod i de første 8 uger af behandlingen, og der var ingen klar sammenhæng med dosis.
English: 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
Danish: 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
English: 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).
Danish: Trobalt skal anvendes med forsigtighed til denne population og det anbefales at reducere start- og vedligeholdelsesdosis (se pkt.
English: 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.
Danish: 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.
English: Trobalt must be withdrawn gradually to minimise the potential for rebound seizures.
Danish: Trobalt skal seponeres gradvist for at minimere risikoen for anfald som følge af seponeringen.
English: A study of cardiac conduction in healthy subjects has demonstrated that retigabine titrated to 1,200 mg/day produced a QT-prolonging effect.
Danish: I et kardielt overledningsstudie hos raske forsøgspersoner blev det påvist, at retigabin titreret til 1.200 mg/dag medførte en forlængelse af QT-intervallet.
English: 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).
Danish: I en række epilepsimodeller hævede retigabin tærsklen for induktion af anfald fremkaldt af maksimalt elektrochok, pentylentetrazol, picrotoxin og N-methyl-D-aspartat (NMDA).
English: A blue-grey discolouration of the skin, lips or nails: this is very common in people taking Trobalt for several years.
Danish: Blågrå misfarvning af hud, læber eller negle: dette er meget almindeligt hos personer, der har taget Trobalt i flere år.
English: Summary of percentage changes in 28-day total partial seizure frequency and responder rates
Danish: Tabel 1 Oversigt over procentvise ændringer i den samlede frekvens af partielle anfald i løbet af 28 dage og respondentrater
English: 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).
Danish: 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.
English: It is unknown whether retigabine is excreted in human breast milk.
Danish: Det vides ikke, om retigabin udskilles i human mælk.
English: The other ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide (E171) , talc (E553b), Lecithin (SOY) and Xanthan gum.
Danish: Øvrige indholdsstoffer: croscarmellosenatrium, hypromellose, magnesiumstearat, mikrokrystallinsk cellulose, polyvinylalkohol, titandioxid (E171), talcum (E553b), lecithin (soja) og xanthangummi.
English: Retigabine is extensively metabolised in humans.
Danish: Retigabin metaboliseres i udtalt grad hos mennesker.
English: Balance disorder Memory impairment
Danish: Balanceforstyrrelser Hukommelsesbesvær Dysfasi
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: The effect of retigabine on human fertility has not been established.
Danish: Effekten af retigabin på fertiliteten hos mennesker er ikke fastlagt.
English: It works by preventing the brain overactivity that causes epileptic seizures (also called fits).
Danish: Det fungerer ved at forhindre den hjerneaktivitet, der forårsager epileptiske anfald (krampeanfald).
English: 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.
Danish: 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.
English: Therefore Trobalt may be taken with or without food.
Danish: Trobalt kan derfor tages med eller uden mad.
English: Mental health problems These are common in people taking Trobalt, and are most likely to happen during the first few months of treatment.
Danish: Disse er almindelige hos personer, der tager Trobalt, og forekommer oftest i løbet af de første få måneders behandling.
English: 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.
Danish: 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.
English: If possible, show them the medicine pack.
Danish: Tag pakningen med, hvis det er muligt.
English: 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).
Danish: 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).
English: These are common in people taking Trobalt, and can lead to not being able to pass urine at all.
Danish: Vandladningsproblemer Disse er almindelige hos personer, der tager Trobalt, og kan medføre, at det slet ikke er muligt at lade vandet.
English: At no observed effect levels, animal exposure in these studies was generally less than that reached in humans at recommended clinical doses.
Danish: 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.
English: 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).
Danish: 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.
English: Discolouration of skin, nails, lips and eyes, and eye disorders caused by changes in the centre of the retina (maculopathy)
Danish: Misfarvning af hud, negle, læber og øjne samt øjensygdom forårsaget af ændring i nethindens centrum (maculopati)
English: The following convention has been used for the classification of adverse reactions:
Danish: Tabel over bivirkninger Der er benyttet følgende konvention til klassificering af bivirkninger:
English: Acquired Vitelliform
Danish: Erhvervet vitelliform
English: There is no evidence for hepatic oxidative metabolism of retigabine or NAMR by cytochrome P450 enzymes.
Danish: Der er ingen tegn på en hepatisk oxidativ metabolisering af retigabin eller NAMR forårsaget af cytochrom P450-enzymer.
English: • effects on heart rhythm.
Danish: • påvirket hjerterytme.
English: Elderly patients may be at increased risk of central nervous system events, urinary retention and atrial fibrillation.
Danish: Ældre patienter kan have en forøget risiko for bivirkninger i centralnervesystemet, urinretention, samt atrieflimren.
English: Eye disorders caused by changes in the centre of the retina (maculopathy): this can be common in people taking Trobalt.
Danish: Øjensygdomme, forårsaget af ændringer i nethindens centrum (maculopati): dette kan være almindeligt hos personer ,der tager Trobalt.
English: Trobalt with alcohol
Danish: Brug af Trobalt sammen med alkohol
English: Contact your doctor or pharmacist for advice if you ever take more Trobalt than you are prescribed.
Danish: Kontakt lægen, skadestuen eller apoteket, hvis du har taget mere Trobalt, end lægen har foreskrevet.
English: 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.
Danish: 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.
English: These may affect up to 1 in 10 people:
Danish: Disse kan forekomme hos op til 1 ud af 100 personer:
English: 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.
Danish: Der var en tilsyneladende sammenhæng mellem dosis og graden af svimmelhed, døsighed, konfusion, afasi, koordinationsbesvær, tremor, balanceforstyrrelser, hukommelsesbesvær, gangforstyrrelser, tågesyn og obstipation.
English: 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).
Danish: 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
English: 84 film-coated tablets Component of a multipack, can't be sold separately
Danish: Del af en multipakning, kan ikke sælges enkeltvis
English: Increased liver function tests
Danish: Forhøjede værdier ved leverfunktionsundersøgelser
English: 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).
Danish: 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.
English: 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).
Danish: 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.
English: Reversibility of retinal pigmentation after retigabine discontinuation has been reported in some subjects.
Danish: Reversibilitet af pigmentforandringer i øjenvæv efter seponering af retigabin har været rapporteret hos nogle personer.
English: Skin and subcutaneous disorders
Danish: Hud og subkutane væv
English: Therefore, retigabine is unlikely to affect the pharmacokinetics of substrates of the major cytochrome P450 isoenzymes through inhibition or induction mechanisms.
Danish: Derfor er det usandsynligt, at retigabin vil påvirke farmakokinetikken af substrater af de primære cytochrom P450isoenzymer gennem hæmnings- eller induktionsmekanismer.
English: You can take Trobalt with or without food.
Danish: Trobalt kan tages med eller uden mad.
English: Doses greater than 900 mg/day are not recommended (see sections 4.4 and 5.2).
Danish: Doser på mere end 900 mg/dag anbefales ikke (se pkt.
English: However, the plasma levels achieved in these studies were less than those reached in humans at recommended doses (see section 5.3).
Danish: Plasmaniveauerne, der blev opnået i disse studier, var imidlertid lavere end de niveauer, der blev set hos mennesker ved de anbefalede doser (se pkt.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: What you need to know before you take Trobalt
Danish: Det skal du vide, før du begynder at tage Trobalt
English: 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.
Danish: 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.
English: Don't take more than one dose at a time to make up for missed doses.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: 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).
Danish: 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.
English: The maternal toxicities interfered with higher dosing of the dams and hence deduction of safety margins with regard to human therapy.
Danish: Den maternale toksicitet interfererede med højere dosering hos moderdyrene og doseringerne kan derfor ikke bruges som sikkerhedsmarginer i forbindelse med evalueringen af reproduktionstoksicitet.
English: Adverse reactions that were most frequently reported to lead to discontinuation were dizziness, somnolence, fatigue and confusional state.
Danish: De hyppigst rapporterede bivirkninger, der førte til seponering, var svimmelhed, døsighed, træthed og konfusion.
English: In rats, retigabine increased the sleep time induced by thiopental sodium from approximately 4 min to 53 min, and the propofol-induced sleep time from approximately 8 min to 12 min.
Danish: Hos rotter forlængede retigabin sovetiden induceret af thiopentalnatrium fra ca. 4 min til 53 min, og den propofol-inducerede sovetid fra ca. 8 min til 12 min. Der var ingen effekt på sovetiden induceret af halothan og methohexitalnatrium.
English: Your doctor will discuss with you whether treatment with Trobalt should be continued.
Danish: Lægen vil sammen med dig beslutte, om behandlingen med Trobalt skal stoppes.
English: A blue-grey discolouration of the skin, lips or nails has also been reported in people taking Trobalt for several years (See Section 4).
Danish: En blågrå misfarvning af huden, læberne eller neglene er også set hos personer, der har taget Trobalt i flere år (se punkt 4).
English: This leaflet was last approved in
Danish: Denne indlægsseddel blev senest ændret
English: Three multicentre, randomized, double-blind, placebo-controlled studies in a total of 1239 adult patients have been conducted to assess the efficacy of retigabine as adjunctive therapy of partial onset seizures, with or without secondary generalisation.
Danish: Klinisk virkning af tillægsbehandling med retigabin ved partielle anfald Der er udført tre randomiserede, dobbeltblindede, placebokontrollerede multicenter-studier, som omfattede 1.239 voksne patienter, med henblik på at vurdere virkningen af retigabin som tillægsbehandling ved partielle anfald med eller uden sekundær generalisering.
English: Based on these pooled data, retigabine did not cause clinically significant effects on the plasma trough concentrations of the following antiepileptic medicinal products: - carbamazepine, clobazam, clonazepam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine,
Danish: Retigabin havde på grundlag af disse samlede data ikke klinisk signifikant påvirkning af dalværdien af plasmakoncentrationerne af følgende antiepileptika: - carbamazepin, clobazam, clonazepam, gabapentin, lamotrigin, levetiracetam, oxcarbazepin,
English: There were no treatment-related effects of retigabine on fertility in animal studies.
Danish: I dyrestudier sås ingen behandlingsrelaterede virkninger af retigabin på fertiliteten.
English: Trobalt must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability.
Danish: Trobalt skal titreres i henhold til den enkelte patients respons, med henblik på at opnå en optimal effekt med færrest mulige bivirkninger.
English: The maximum total daily starting dose is 300 mg (100 mg three times daily).
Danish: Den maksimale totale daglige startdosis er 300 mg (100 mg 3 gange daglig).
English: If retinal pigment changes, vitelliform maculopathy or vision changes are detected, treatment with Trobalt should only be continued after a careful re-assessment of the balance of benefits and risks.
Danish: Hvis der opdages pigmentforandringer i nethinden, vitelliform maculopati eller synsforandringer, må behandling med Trobalt kun fortsættes efter en grundig reevaluering af fordele og risici.
English: Do not reduce your dose unless your doctor tells you to. To stop taking Trobalt, it is important that the dose is reduced gradually, over at least 3 weeks.
Danish: Hvis du skal stoppe med at tage Trobalt, er det vigtigt, at dosis nedsættes gradvist over mindst 3 uger.
English: The total daily starting dose is 150 mg/day and during the titration period the total daily dose should be increased by a maximum of 150 mg every week, according to the individual patient response and tolerability.
Danish: Den totale daglige startdosis er 150 mg/dag, og den totale daglige dosis bør i titreringsperioden øges med maksimalt 150 mg hver uge alt efter den enkelte patients respons og tolerance.
English: Further, based on pooled data, there were no clinically significant effects of the following antiepileptic medicinal products on retigabine pharmacokinetics: - lamotrigine, levetiracetam, oxcarbazepine, topiramate, valproate.
Danish: På grundlag af sammenlagte data var der derudover ingen klinisk signifikant påvirkning af følgende antiepileptika på retigabins farmakokinetik: - lamotrigin, levetiracetam, oxcarbazepin, topiramat og valproat.
English: The retigabine AUC was increased by approximately 50% in volunteers with moderate hepatic impairment (Child-Pugh score 7 to 9) and by approximately 100% in volunteers with severe hepatic impairment (Child-Pugh score >9), relative to healthy volunteers.
Danish: AUC for retigabin blev øget med ca. 50 % hos frivillige forsøgspersoner med moderat nedsat leverfunktion (Child-Pugh-score på 7 til 9) og med ca. 100 % hos frivillige forsøgspersoner med svært nedsat leverfunktion (Child-Pugh-score > 9) i forhold til hos raske frivillige forsøgspersoner.
English: Adverse event data from clinical trial subjects showed a rate of event of discolouration of the nails, lips, skin and/or mucosa per patient year of exposure of 3.6%.
Danish: Bivirkningsdata fra kliniske studier viste en hyppighed på 3,6 % pr. patientår for bivirkningen misfarvning af negle, læber, hud og/eller slimhinder.
English: Discolouration of parts of the eye, including the retina (inside the back of the eye) has been reported in people taking Trobalt for several years (see Section 4).
Danish: Misfarvning af dele af øjet, herunder nethinden (i den bageste del af øjet) har været rapporteret hos personer, der har taget Trobalt i flere år (se punkt 4).
English: During an 8-week baseline period, patients had to experience ≥4 partial onset seizures per 28 days.
Danish: Patienterne skulle have ≥ 4 partielle anfald pr. 28 dage i løbet af en baselineperiode på 8 uger.
English: Eye disorders caused by changes in the centre of the retina (maculopathy) have been reported in people taking Trobalt (see Section 4).
Danish: Øjensygdomme forårsaget af ændringer i nethindens centrum (maculopati) har været set hos personer, der tager Trobalt (se punkt 4).
English: Therefore, co-administration with inhibitors or inducers of cytochrome P450 enzymes is unlikely to affect the pharmacokinetics of retigabine or NAMR.
Danish: Derfor er det ikke sandsynligt, at samtidig administration med hæmmere eller induktorer af cytochrom P450-enzymer har indflydelse på farmakokinetikken af retigabin eller NAMR.
English: • changes in liver function, which will show up in blood tests.
Danish: • følelse af svaghed eller generel utilpashed • ændringer i leverfunktionen, hvilket kan ses ved blodprøver.
English: Swallow the tablet whole.
Danish: Tabletterne skal synkes hele.
English: Adjustment of the Trobalt dose is recommended in patients with moderate to severe renal impairment but no adjustment of the Trobalt dose is recommended in patients with mild renal impairment (see section 4.2).
Danish: Justering af dosis af Trobalt anbefales hos patienter med moderat til svært nedsat nyrefunktion, mens der ikke anbefales dosisjustering hos patienter med let nedsat nyrefunktion (se pkt.
English: Confusional state, psychotic disorders and hallucinations were reported in controlled clinical studies with retigabine (see section 4.8).
Danish: Der blev rapporteret konfusion, psykotiske forstyrrelser og hallucinationer i kontrollerede kliniske studier med retigabin (se pkt.
English: The 200 mg tablets also contain iron oxide yellow (E172).
Danish: 200 mg tabletter indeholder også gult jernoxid (E172).
English: • lack of co-ordination; spinning sensation (vertigo); balance problems; problems walking
Danish: • manglende koordination, snurrende fornemmelse i hovedet (vertigo), balanceforstyrrelser,
English: Pack containing 84 film-coated tablets; multi-pack comprising 168 (2 x 84) film-coated tablets.
Danish: Pakning indeholder 84 filmovertrukne tabletter; multipakning indeholder 168 (2 x 84) filmovertrukne tabletter.