FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients enrolled were to have had seizures that were not adequately controlled with 1 to 3 concomitant antiepileptic medicinal products, and more than 75% of all patients were taking ≥2 concurrent antiepileptic medicinal products.
Danish: Alle inkluderede patienter skulle have haft anfald, der ikke var tilstrækkeligt kontrolleret med 1 til 3 samtidigt administrerede antiepileptika.
English: At retigabine doses of up to 750 mg/day, there was no clinically significant effect of retigabine on the pharmacokinetics of the estrogen (ethinyl estradiol) or progestogen (norethindrone) components of the oral contraceptive pill.
Danish: Ved retigabindoser på op til 750 mg/dag havde retigabin ingen klinisk signifikant virkning på farmakokinetikken af østrogenkomponenten (ethinylestradiol) eller gestagenkomponenten (norethisteron) i p-piller, og lavdosis-kombinations-p-pillen havde ingen klinisk signifikant virkning på retigabins farmakokinetik.
English: The 50 mg and 400 mg tablets also contain indigo carmine aluminium lake (E132) and carmine (E120).
Danish: 50 mg og 400 mg tabletter indeholder også indigocarmin aluminiumpigment (E132) og carmin (E120).
English: No signs of gall bladder dysfunction were seen clinically.
Danish: Klinisk blev der ikke set tegn på dysfunktion af galdeblæren.
English: In a single-dose study, retigabine AUC was increased by approximately 30% in volunteers with mild renal impairment (creatinine clearance 50 to 80 ml/min) and by approximately 100% in volunteers with moderate to severe renal impairment (creatinine clearance <50 ml/min), relative to healthy volunteers.
Danish: I et studie med enkeltdoser blev AUC for retigabin øget med ca. 30 % hos frivillige forsøgspersoner med let nedsat nyrefunktion (kreatininclearance på 50-80 ml/min), og med ca. 100 % hos frivillige forsøgspersoner med moderat til svært nedsat nyrefunktion (kreatininclearance < 50 ml/min), i forhold til hos raske frivillige forsøgspersoner.
English: Retigabine overdoses in excess of 2,500 mg/day were reported during clinical studies.
Danish: I kliniske studier er der rapporteret om overdoseringer med retigabin-doser på over 2.500 mg/dag.
English: Don't stop unless your doctor advises you to.
Danish: Du må ikke nedsætte dine doser, medmindre lægen beder dig om det.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX - MULTIPACK ONLY)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MELLEMLIGGENDE KARTON (UDEN BLÅ BOKS - KUN MULTIPAKNING)
English: Marketing Authorisation Holder Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom.
Danish: Indehaver af markedsføringstilladelsen Glaxo Group Limited, 980 Great West Road, Brentford,
English: The majority of adverse reactions occurred in the first 8 weeks of treatment, and there was an apparent dose-relationship for confusional state only.
Danish: Størstedelen af bivirkningerne opstod i de første 8 uger af behandlingen, og der var kun en klar sammenhæng med dosis i forbindelse med konfusion.
English: Retigabine may increase the duration of anaesthesia induced by some anaesthetics (for example thiopental sodium).
Danish: Retigabin kan øge varigheden af anæstesi induceret af visse anæstetika (f.eks. thiopentalnatrium).
English: No dose adjustment is required in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min; see section 5.2).
Danish: Dosisjustering er ikke påkrævet hos patienter med let nedsat nyrefunktion (kreatininclearance på 5080 ml/min, se pkt.
English: Trobalt may be taken with or without food (see section 5.2).
Danish: Det kan indtages med eller uden mad (se pkt.
English: In these patients it is recommended that an electrocardiogram (ECG) is recorded before initiation of treatment with Trobalt and in those with a corrected QT interval >440ms at baseline, an ECG should be recorded on reaching the maintenance dose.
Danish: Hos patienter med et korrigeret QT-interval > 440 ms ved baseline, bør ekg tages på det tidspunkt, hvor vedligeholdelsesdosis opnås.
English: • balance problems, lack of co-ordination, spinning sensation (vertigo), problems walking
Danish: • balanceforstyrrelser, manglende koordination, snurrende fornemmelse i hovedet (vertigo),
English: Polyvinyl alcohol Titanium dioxide (E171) Talc (E553b) Iron oxide yellow (E172).
Danish: Polyvinylalkohol Titandioxid (E171) Talcum (E553b) Gult jernoxid (E172) Lecithin (soja) Xanthangummi.
English: Adverse reactions such as dizziness, somnolence, diplopia and blurred vision were reported in controlled clinical studies, particularly during titration (see section 4.8).
Danish: Bivirkninger som svimmelhed, døsighed, diplopi og tågesyn blev rapporteret i kontrollerede kliniske studier, særligt under titreringen (se pkt.
English: Skin rash Hyperhidrosis
Danish: Udslæt Hyperhidrose
English: Prior to launch in each Member State, and also after changes to the key elements in the educational material the MAH shall agree the final educational material with the National Competent Authority.
Danish: Medlemslandene skal sammen med indehaveren af markedsføringstilladelsen aftale detaljerne omkring det endelige undervisningsmateriale inden markedsføring af produktet samt efter ændringer i de væsentlige elementer af undervisningsmaterialet.
English: Don't chew, crush or split the tablet.
Danish: Tabletterne må ikke tygges, knuses eller brækkes over.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Trobalt in paediatric patients aged 0 to below 2 years with Lennox Gastaut Syndrome (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Trobalt hos pædiatriske patienter i alderen fra 0 til under 2 år med Lennox-Gastaut-syndrom (se pkt.
English: No dose reduction is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6; see section 5.2).
Danish: Dosisjustering er ikke påkrævet hos patienter med let nedsat leverfunktion (Child-Pugh-score på 5 til 6, se pkt.
English: Other antiepileptic medicinal products
Danish: Andre antiepileptika
English: Drinking alcohol with Trobalt can make your vision blurred.
Danish: Hvis du drikker alkohol, mens du er i behandling med Trobalt, kan du få sløret syn.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Trobalt in paediatric patients aged 2 to below 18 years with Lennox Gastaut Syndrome, and in paediatric patients aged 0 to below 18 years with partial onset seizures (see section 4.2 for information on paediatric use) .
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Trobalt hos pædiatriske patienter i alderen fra 2 til under 18 år med Lennox-Gastaut-syndrom og hos pædiatriske patienter i alderen fra 0 til under 18 år med partielle anfald (se pkt.
English: Retigabine
Danish: Retigabin
English: Further management should be as recommended by the national poisons centre, where available.
Danish: Yderligere behandling skal ske i henhold til Giftlinjens anbefalinger.
English: − Caution when using TROBALT in patients with a cardiac disease or those taking medicines concomitantly known to cause QT prolongation
Danish: o Nødvendigheden af at informere patienterne om bivirkninger relateret til QT-forlængelse o At der skal udvises forsigtighed ved anvendelse af Trobalt hos patienter med hjertesygdom eller patienter, der samtidig tager lægemidler, der er kendt for at forlænge QT-intervallet.
English: System Organ Class
Danish: Systemorganklasse Meget almindelig Almindelig
English: − The need to inform patients that TROBALT may cause or potentiate symptoms of urinary retention/urinary hesitation
Danish: Vejledningen skal indeholde følgende centrale punkter: o Nødvendigheden af at informere patienterne om, at Trobalt kan forårsage eller forværre symptomer på urinretention eller manglende evne til at påbegynde vandladning.
English: Study 302 (n=538; n=471)
Danish: Studie 302 (n=538; n=471) Samlet frekvens af partielle anfald (median), ændring i %
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX - MULTIPACK ONLY)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET (MED BLÅ BOKS - KUN MULTIPAKNING)
English: Trobalt may affect some anaesthetics (for example thiopental sodium).
Danish: Trobalt kan påvirke virkningen af visse bedøvelsesmidler (f.eks. thiopentalnatrium).
English: The maximum dose is 400 mg taken three times a day (a total of 1,200 mg a day).
Danish: Der må højst tages en dosis på 400 mg 3 gange daglig (en dosis på i alt 1.200 mg om dagen).
English: In a single-dose study in healthy volunteers and subjects with end stage renal disease, the retigabine AUC was increased by approximately 100% in the subjects with end stage renal disease relative to healthy volunteers.
Danish: I et studie med enkeltdoser hos frivillige raske forsøgspersoner og personer med nyresygdom i slutstadiet blev AUC for retigabin øget med ca. 100 % hos personerne med nyresygdom i slutstadiet i forhold til hos raske frivillige forsøgspersoner.
English: • constipation; feeling sick (nausea); indigestion; dry mouth
Danish: • forstoppelse, kvalme, fordøjelsesbesvær, mundtørhed
English: Therefore Trobalt is not recommended during pregnancy.You must use a reliable method of contraception to avoid becoming pregnant while you are being treated with Trobalt.
Danish: Du skal anvende sikker prævention, for at undgå at blive gravid, mens du er i behandling med Trobalt.
English: ≥1/1,000 to <1/100
Danish: Ikke almindelig: ≥ 1/1.000 til < 1/100 Sjælden:
English: Indigo carmine aluminium lake (E132) Carmine (E120).
Danish: Indigocarmin aluminiumpigment (E132) Carmin (E120)
English: The MAH shall ensure that, at launch and after launch, neurologists, ophthalmologists and other healthcare professionals (according to national requirements) are provided with a physician information pack containing the following elements:
Danish: Indehaveren af markedsføringstilladelsen i forbindelse med markedsføring samt efter markedsføring sikre at der udleveres en informationspakke til alle neurologer, øjenlæger og andre sundhedsfaglige personer (efter nationale krav).
English: A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe hepatic impairment (Child-Pugh score ≥7; see section 5.2).
Danish: Det anbefales at reducere start- og vedligeholdelsesdosis af Trobalt med 50 % hos patienter med moderat eller svært nedsat leverfunktion (Child-Pugh-score ≥ 7, se pkt.
English: In a study in volunteers, cardiac arrhythmia (cardiac arrest/asystole or ventricular tachycardia) occurred in two subjects within 3 hours of receiving a single 900 mg retigabine dose.
Danish: I et studie hos frivillige forsøgspersoner opstod der hjertearytmi (hjertestop/asystoli eller ventrikulær takykardi) hos 2 forsøgspersoner inden for 3 timer efter administration af en enkelt dosis retigabin på 900 mg. Arytmierne forsvandt spontant, og begge frivillige forsøgspersoner kom sig uden følger.
English: The active substance is retigabine.
Danish: Aktivt stof: retigabin.
English: A 50% reduction in the initial and maintenance dose of Trobalt is recommended in patients with moderate or severe renal impairment (creatinine clearance <50 ml/min; see section 5.2).
Danish: Det anbefales at reducere start- og vedligeholdelsesdosis af Trobalt med 50 % hos patienter med moderat eller svært nedsat nyrefunktion (kreatininclearance < 50 ml/min, se pkt.
English: If you are not sure what to do, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Haemodialysis has been shown to reduce the plasma concentrations of retigabine and NAMR by approximately 50%.
Danish: Det er vist, at hæmodialyse reducerer plasmakoncentrationerne af retigabin og NAMR med omkring
English: The drug interaction potential was, therefore, evaluated based on a pooled analysis across clinical studies and whilst not considered as robust as stand-alone clinical interaction studies, the results support the in vitro data.
Danish: Selvom denne type analyse ikke kan anses som værende ligeså robust som egentlige kliniske interaktionsstudier, støttede analysens resultater de fundne in vitro data.
English: The 100 mg and 300 mg tablets also contain indigo carmine aluminium lake (E132) and iron oxide yellow (E172).
Danish: 100 mg og 300 mg tabletter indeholder også indigocarmin aluminiumpigment (E132) og gult jernoxid (E172).
English: Common side effects
Danish: Ikke almindelige bivirkninger
English: Each pack contains blisters of 84 or 2 x 84 film-coated tablets.
Danish: Hver pakning indeholder 84 eller 2 x 84 filmovertrukne tabletter.
English: The doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are pregnant.
Danish: Din læge vil afveje dine fordele ved behandling med Trobalt under graviditet op imod risici for barnet.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget du er i tvivl om.
English: Lecithin (SOY)
Danish: Lecithin (soja)
English: The maximum starting dose of Trobalt is 100 mg, taken three times a day (a total of 300 mg a day).
Danish: Den maksimale startdosis af Trobalt er 100 mg 3 gange daglig (dosis på i alt 300 mg om dagen).
English: • confusion
Danish: Konfusion
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 March 2011
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
English: Uncommon side effects These may affect up to 1 in 100 people:
Danish: Almindelige bivirkninger Disse kan forekomme hos op til 1 ud af 10 personer:
English: In addition a distinct form of macular abnormality with features of vitelliform maculopathy (see section 4.8) has also been identified, in most cases diagnosed with optical coherence tomography (OCT) imaging.
Danish: Derudover er der også identificeret en særlig form for makulær abnormalitet med udslag af vitelliform maculopati (se pkt.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Trobalt Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Xanthan gum
Danish: Xanthangummi.
English: Currently available pharmacokinetic data are described in section 5.2, but no recommendation on a posology can be made.
Danish: Nuværende tilgængelige farmakokinetiske data er beskrevet i pkt.
English: Your doctor will weigh up the benefit to you against any risk to your baby of taking Trobalt while you are breast-feeding.
Danish: Din læge vil afveje dine fordele ved behandling med Trobalt under amning op imod risici for barnet.
English: Study 205 (n=396; n=303)
Danish: Studie 205 (n=396, n=303) Samlet frekvens af partielle anfald (median), ændring i %
English: Study 301 (n=305; n=256)
Danish: Studie 301 (n=305, n=256) Samlet frekvens af partielle anfald (median), ændring i %
English: Peripheral oedema
Danish: Avda Extremadura 3
English: Each pack contains blisters of 21or 84 film-coated tablets.
Danish: Hver pakning indeholder 21 eller 84 filmovertrukne tabletter.
English: Purple, round, film-coated tablets of 5.6 mm, marked with “RTG 50” on one side.
Danish: Lilla, runde, filmovertrukne tabletter på 5,6 mm, mærket "RTG 50" på den ene side.
English: Adjustment of the Trobalt dose is recommended in patients with moderate or severe hepatic impairment (see section 4.2).
Danish: Det anbefales at justere dosis af Trobalt hos patienter med moderat eller svært nedsat leverfunktion (se pkt.
English: Packs containing 21or 84 film-coated tablets.
Danish: Pakningerne indeholder 21 eller 84 filmovertrukne tabletter.
English: 50 mg tablets:
Danish: 50 mg tabletter:
English: − The need to inform patients that TROBALT may cause pigment changes in ocular tissues, including the retina, and also in the skin, lips and/or nails, as well as a distinct form of macular abnormality with features of vitelliform maculopathy;
Danish: o Nødvendigheden af at informere patienterne om, at Trobalt kan forårsage forvirring, hallucinationer og psykotiske forstyrrelser og om, at det er nødvendigt at følge dosistitreringen for at minimere disse risici; o Nødvendigheden af at informere patienterne om, at Trobalt kan forårsage pigmentforandringer i øjenvævet, herunder nethinden, og også i huden, læberne og/eller neglene samt en særlig form for makulær abnormalitet med udslag af vitelliform o Nødvendigheden af omfattende oftalmologiske undersøgelser, inklusive visuel skarphed, spaltelampeundersøgelse og udvidet fundos fotografering og makulær optisk koherenstomografi (OCT) scan ved behandlingsstart og mindst hver 6. måned herefter, så længe behandlingen er i gang.
English: Dysphagia
Danish: Hæmaturi
English: Trobalt may increase the duration of anaesthesia induced by some anaesthetics (for example thiopental sodium; see section 5.1).
Danish: Interaktion med anæstetika Trobalt kan øge varigheden af anæstesi induceret af visse anæstetika (f.eks. thiopentalnatrium, se pkt.
English: What is in this leaflet What Trobalt is and what it is used for What you need to know before you take Trobalt
Danish: Oversigt over indlægssedlen Det skal du vide, før du begynder at tage Trobalt
English: Multipack: 168 (2 packs of 84) film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Multipakning: 168 (2 pakninger a 84) filmovertrukne tabletter
English: Green, round, film-coated tablets of 7.1 mm, marked with “RTG 100” on one side.
Danish: Grønne, runde, filmovertrukne tabletter på 7,1 mm, mærket "RTG 100" på den ene side.
English: Urinary retention Nephrolithiasis
Danish: Urinretention Nyresten
English: Memory impairment
Danish: Svimmelhed Døsighed
English: Manufacturer
Danish: • Produktresumé
English: Indigo carmine aluminium lake (E132) Iron oxide yellow (E172).
Danish: Indigocarmin aluminiumpigment (E132) Gult jernoxid (E172) Lecithin (soja)
English: Trobalt 200 mg film-coated tablets are yellow, oblong and marked “RTG-200” on one side.
Danish: Trobalt 200 mg filmovertrukne tabletter er gule, aflange og mærket "RTG-200" på den ene side.
English: Yellow, oblong, film-coated tablets of 7.1 mm x 14 mm, marked with “RTG-200” on one side.
Danish: Gule, aflange, filmovertrukne tabletter på 7,1 mm x 14 mm, mærket "RTG-200" på den ene side.
English: INFORMATION IN BRAILLE trobalt 50 mg
Danish: INFORMATION I BRAILLE-SKRIFT trobalt 50 mg
English: Name and address of the manufacturer(s) responsible for batch release
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse Glaxo Wellcome S.A.
English: Trobalt 100 mg film-coated tablets are green, round and marked “RTG 100” on one side.
Danish: Trobalt 100 mg filmovertrukne tabletter er grønne, runde og mærket "RTG 100" på den ene side.
English: Purple, oblong, film-coated tablets of 8.1 mm x 18 mm, marked with “RTG-400” on one side.
Danish: Lilla, aflange, filmovertrukne tabletter på 8,1 mm x 18 mm, mærket "RTG-400" på den ene side.
English: All patients should undergo comprehensive ophthalmological examinations at baseline and at least every six months, which should include visual acuity, slit-lamp examination, dilated fundus photography, and macular OCT imaging.
Danish: Undersøgelserne skal inkludere visus-undersøgelse, spaltelampeundersøgelse, udvidet fundusfotografering og makulært OCT scan.
English: Talk to your doctor about breast-feeding while you are taking Trobalt.
Danish: Tal med lægen om amning og behandling med Trobalt.
English: Withdrawal seizures
Danish: Anfald i forbindelse med seponering
English: 400 mg tablets:
Danish: 400 mg tabletter:
English: • drowsiness
Danish: • døsighed
English: 300 mg tablets:
Danish: 300 mg tabletter:
English: Green, oblong, film-coated tablets of 7.1 mm x 16 mm, marked with “RTG-300” on one side.
Danish: Grønne, aflange, filmovertrukne tabletter på 7,1 mm x 16 mm, mærket "RTG-300" på den ene side.
English: INFORMATION IN BRAILLE trobalt 200 mg
Danish: INFORMATION I BRAILLE-SKRIFT trobalt 200 mg
English: 200 mg tablets:
Danish: 200 mg tabletter:
English: Trobalt 300 mg film-coated tablets are green, oblong and marked “RTG-300” on one side.
Danish: Trobalt 300 mg filmovertrukne tabletter er grønne, aflange og mærket "RTG-300" på den ene side.
English: 100 mg tablets:
Danish: 100 mg tabletter:
English: There were no reported sequelae.
Danish: Der blev ikke rapporteret nogen følger.
English: Pigment changes (discolouration) of ocular tissues, including the retina have been reported in longterm clinical studies withretigabine, sometimes but not always in conjunction with pigment changes of the skin, lips or nails (see below paragraph and section 4.8).
Danish: Dette har i nogle tilfælde, men ikke altid, været set i forbindelse med pigmentforandringer i hud, læber eller negle (se afsnittet nedenfor og pkt.
English: INFORMATION IN BRAILLE trobalt 400 mg
Danish: INFORMATION I BRAILLE-SKRIFT trobalt 400 mg
English: INFORMATION IN BRAILLE trobalt 300 mg
Danish: INFORMATION I BRAILLE-SKRIFT trobalt 300 mg
English: INFORMATION IN BRAILLE trobalt 100 mg
Danish: INFORMATION I BRAILLE-SKRIFT trobalt 100 mg
English: Breastfeeding
Danish: Dysfagi
English: The physician's guide should include the following key messages:
Danish: Informationspakken skal indeholde følgende:
English: Trobalt 400 mg film-coated tablets are purple, oblong and marked “RTG-400” on one side.
Danish: Trobalt 400 mg filmovertrukne tabletter er lilla, aflange og mærket "RTG-400" på den ene side.
English: NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Trobalt 50 mg filmovertrukne tabletter
English: Hepatic impairment
Danish: Svimmelhed døsighed
English: NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Trobalt 300 mg filmovertrukne tabletter
English: Each tablet contains 300 mg retigabine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 300 mg retigabin
English: NAME OF THE MEDICINAL PRODUCT Trobalt 200 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Trobalt 200 mg filmovertrukne tabletter
English: ≥1/10,000 to <1/1,000
Danish: Meget sjælden: < 1/10.000.
English: Each tablet contains 200 mg retigabine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 200 mg retigabin
English: NAME OF THE MEDICINAL PRODUCT Trobalt 400 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Trobalt 400 mg filmovertrukne tabletter
English: NAME OF THE MEDICINAL PRODUCT Trobalt 100 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Trobalt 100 mg filmovertrukne tabletter
English: Each tablet contains 50 mg retigabine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 50 mg retigabin
English: NAME OF THE MEDICINAL PRODUCT Trobalt 50 mg film-coated tablets retigabine
Danish: LÆGEMIDLETS NAVN Trobalt 50 mg filmovertrukne tabletter retigabin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of retigabine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 300 mg retigabin.
English: Coordination abnormal
Danish: Blågrå misfarvning
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of retigabine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 50 mg retigabin.
English: Pigment changes (discolouration) of the skin, lips or nails have been reported in long-term clinical studies with retigabine, sometimes but not always in conjunction with pigment changes of ocular tissues (see above paragraph and section 4.8).
Danish: Pigmentforandringer (misfarvning) i hud, læber og negle har været rapporteret i kliniske langtidsstudier med retigabin.
English: Each tablet contains 400 mg retigabine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 400 mg retigabin
English: NAME OF THE MEDICINAL PRODUCT Trobalt 300 mg film-coated tablets retigabine
Danish: LÆGEMIDLETS NAVN Trobalt 300 mg filmovertrukne tabletter retigabin