FrancophonIA/ELRC3.0 huggingface dataset:
English: This change in colour is harmless - it does not mean your treatment needs to change.
Danish: Denne farveændring er harmløs - den betyder ikke, at din behandling behøver ændres.
English: Analysis according to Mixed Model of Repeated Measures
Danish: Analyseret med blandet model for gentagne målinger
English: Due date of final report: 31 August 2021
Danish: Dato for slutrapport: 31. august 2021
English: This medicinal product has been authorised under ‘exceptional circumstances'.
Danish: Dette lægemiddel er godkendt under “særlige vilkår”.
English: Each bottle contains 180 tablets.
Danish: Hver flaske indeholder 180 tabletter.
English: - Tell your doctor if your urine changes colour.
Danish: - Tal med lægen, hvis din urin ændrer farve.
English: Treatment should be initiated and supervised by a physician with experience in LHON.
Danish: Behandlingen bør iværksættes og overvåges af en læge med erfaring i LHON.
English: Preferred Term
Danish: Foretrukken betegnelse
English: No report of overdose has been received from the RHODOS study.
Danish: Der er ikke indberettet tilfælde af overdosering i RHODOS-undersøgelsen.
English: - Swallow the tablets whole with a glass of liquid.
Danish: - Synk tabletterne hele med et glas vand.
English: Your doctor will check your eye-sight before you start taking this medicine and then at regular visits while you are taking it.
Danish: Lægen vil kontrollere dit syn, før du begynder at tage dette lægemiddel, og efterfølgende ved de regelmæssige besøg, mens du får lægemidlet.
English: The recommended dose is 2 tablets three times a day - this is a total of 6 tablets per day.
Danish: Den anbefalede dosis er 2 tabletter tre gange dagligt - i alt 6 tabletter dagligt.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som alle andre lægemidlergive bivirkninger, men ikke alle får bivirkninger.
English: There are no data concerning the effect of exposure to idebenone on human fertility.
Danish: Der foreligger ingen data om virkningen af eksponering for idebenon på fertiliteten hos mennesker.
English: - Raxone is supplied in white plastic bottles.
Danish: - Raxone leveres i hvide plastflasker.
English: If you take more Raxone than you should, talk to your doctor straight away.
Danish: Hvis du har taget mere Raxone end du skal, skal du straks tale med lægen.
English: Macrogol 3350
Danish: Tabletovertræk Macrogol 3350
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: Dyreforsøg viser hverken direkte eller indirekte skadevirkninger vedrørende reproduktionstoksicitet.
English: Change in urine colour
Danish: Ændring af urinens farve
English: - LHON can lead to loss of eyesight due to the inactivity of cells responsible for vision.
Danish: - LHON kan medføre synstab på grund af inaktiviteten af de celler, der er ansvarlige for synet.
English: Treatment with Raxone can restore the ability of cells to produce energy and so allow inactive eye cells to work again.
Danish: Behandling med Raxone kan genoprette cellernes evne til at producere energi, så de inaktive øjenceller kan komme til at fungere igen.
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 12 months following authorisation.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 12 måneder efter godkendelsen.
English: Exclusion of this patient yielded similar results as in the ITT population; as could be expected, the difference between idebenone and placebo arm was slightly larger.
Danish: Eksklusion af denne patient gav samme resultater som i ITT-populationen; forskellen mellem idebenon- og placeboarmen var som forventet lidt større.
English: QS6+QS6 represented 6.45% to 9.46%, whereas QS10+QS10-C and IDE+IDE-C were close to 1% or below.
Danish: QS6+QS6 repræsenterede 6,45 % til 9,46 %, mens QS10+QS10-C og IDE+IDE-C var nær 1 % eller derunder.
English: Endpoint (ITT)
Danish: Endepunkt (ITT)
English: Frequency groupings are defined to the following convention: very common (≥1/10), common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke kendt (kan ikke vurderes ud fra de foreliggende oplysninger).
English: Currently available data are described in sections 5.1 and 5.2, but no recommendation on posology can be made.
Danish: 5.1 og 5.2, men der kan ikke gives nogen anbefalinger for doseringen.
English: Caution should be exercised to ensure that the chromaturia does not mask changes of colour due to other reasons (e.g. renal or blood disorders).
Danish: Der bør udvises forsigtighed med henblik på, at kromaturi ikke maskerer farveændringer af anden årsag (f.eks. nyre- eller blodsygdom).
English: - Take the tablets with food - this helps to get more of the medicine from your stomach into your blood.
Danish: - Tag tabletterne sammen med et måltid - det medvirker til, at en større del af lægemidlet optages i blodet fra maven.
English: Neither idebenone nor its metabolites showed time-dependent pharmacokinetics.
Danish: Hverken idebenon eller dets metabolitter udviste tidsafhængig farmakokinetik.
English: You can also report side effects directly via the national reporting system in Appendix V. By reporting side effecs you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The tablets should not be broken or chewed.
Danish: Tabletterne må ikke knuses eller tygges.
English: If you have been told by your doctor that you have lactose intolerance or that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Danish: Hvis lægen har fortalt dig, at du har lactoseintolerans, eller hvis du ikke kan tåle eller fordøje visse sukkerarter, skal du tale med lægen, før du tager dette lægemiddel.
English: Raxone was given as 3 daily doses of 300 mg each with meals.
Danish: Raxone blev givet som 3 daglige doser på hver 300 mg sammen med måltiderne.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogent potentiale samt reproduktions- og udviklingstoksicitet.
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: E. SÆRLIG FORPLIGTELSE TIL AT TRÆFFE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE UNDER SÆRLIGE VILKÅR
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: Some medicine may interact with Raxone.
Danish: Nogle lægemidler kan vekselvirke med Raxone.
English: The main metabolites in plasma are IDE-C and QS4+QS4-C.
Danish: Hovedmetabolitterne i plasma er IDE-C og QS4+QS4-C.
English: Raxone film-coated tablets should be swallowed whole with water.
Danish: Raxone filmovertrukne tabletter skal synkes hele med vand.
English: In addition, no induction of CYP1A2, CYP2B6 or CYP3A4 was observed.
Danish: Der er derudover ikke iagttaget induktion af CYP1A2, CYP2B6 eller CYP3A4.
English: Idebenone is not a substrate for p-gp in vitro.
Danish: Idebenon er ikke substrat for p-gp in vitro.
English: Clinical safety and efficacy of idebenone in LHON have been assessed in one double-blind, randomised, placebo-controlled study (RHODOS).
Danish: Den kliniske sikkerhed og virkningen af idebenon ved LHON er blevet vurderet i én dobbeltblindet, randomiseret, placebokontrolleret undersøgelse (RHODOS).
English: This will take into account the benefit of breast-feeding to the child and the benefit of the medicine for you.
Danish: Dette vil ske under hensyn til fordelene ved amning for barnet og fordelene ved lægemidlet for dig.
English: After oral administration of Raxone, idebenone is rapidly absorbed.
Danish: Efter oral administration af Raxone absorberes idebenon hurtigt.
English: Raxone should be administered with food because food increases the bioavailability of idebenone.
Danish: Raxone skal administreres sammen med et måltid, da fødeindtagelse øger biotilgængeligheden af idebenon.
English: Patients received either 900 mg/day Raxone or placebo for a period of 24 weeks (6 months).
Danish: Patienterne fik enten Raxone, 900 mg dagligt, eller placebo i en periode på 24 uger (6 måneder).
English: Experimental data have shown that idebenone passes the blood-brain barrier and is distributed at significant concentrations in cerebral tissue.
Danish: Forsøgsdata har vist, at idebenon krydser blod-hjernebarrieren og fordeles med betydelig koncentration i hjernevævet.
English: This can lead to some improvement in lost eyesight.
Danish: Dette kan i nogen grad genoprette den tabte synsstyrke.
English: If you are breast-feeding your doctor will discuss with you whether to stop breast-feeding or to stop taking the medicine.
Danish: Hvis du ammer, vil lægen drøfte med dig, om du skal holde op med at amme eller holde op med at tage lægemidlet.
English: Clinical particulars 4.1 Therapeutic indications
Danish: KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer
English: Interim reports should be provided at the time of annual reassessments.
Danish: Der forelægges interimrapporter på tidspunktet for de årlige revurderinger.
English: The main route of elimination is metabolism, with the majority of dose excreted via the kidneys as metabolites.
Danish: Den vigtigste eliminationsvej er metabolisme, idet størstedelen af dosis udskilles via nyrerne som metabolitter.
English: Talk to your doctor or pharmacist before taking Raxone if: - you have any blood, liver or kidney problems.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Raxone: - hvis du har blod-, lever- eller nyreproblemer.
English: - He or she may do a urine check to make sure the change in colour is not hiding other problems.
Danish: - Lægen vil muligvis tage en urinprøve for at sikre, at den ændrede farve ikke skyldes andre problemer.
English: After a single or repeated oral dose of 750 mg Raxone, QS4+QS4-C were the most prominent idebenone-derived metabolites in urine, representing on average between 49.3% and 68.3% of the total administered dose.
Danish: Efter en enkelt eller gentagne orale doser af 750 mg Raxone var QS4+QS4-C de dominerende idebenon-deriverede metabolitter i urinen og udgjorde gennemsnitligt mellem 49,3 % og 68,3 % af den samlede administrerede dosis.
English: Talk to your doctor before you stop taking this medicine.
Danish: Kontakt lægen, før du holder op med at bruge dette lægemiddel.
English: There is no specific antidote for idebenone.
Danish: Der er ingen specifik modgift mod idebenon.
English: - Do not crush or chew the tablets.
Danish: - Du må ikke knuse eller tygge tabletterne.
English: Depending on the time since symptom onset and the proportion of RGCs already affected, idebenone can promote recovery of vision in patients who experience vision loss.
Danish: Afhængigt af den forløbne tid siden symptomernes indsætten og andelen af allerede berørte RGC kan idebenon bevirke genvinding af synet hos patienter med synstab.
English: The recommended dose is 900 mg/day idebenone (300 mg, 3 times a day).
Danish: Den anbefalede dosis er 900 mg idebenon dagligt (300 mg 3 gange dagligt).
English: If you forget a dose, skip the missed dose.
Danish: Hvis du glemmer at tage en dosis, skal du springe den glemte dosis over.
English: In the EAP the number of responders increased with longer treatment duration, from 19 out of 62 patients (30.6%) at 6 months to 17 out of 47 patients (36.2%) at 12 months.
Danish: EAP steg andelen af responderende patienter med behandlingsvarigheden fra 19 ud af 62 patienter (30,6 %) ved 6 måneder til 17 ud af 47 patienter (36,2 %) ved 12 måneder.
English: Table 2: Proportion of patients with clinically relevant recovery of VA after 6 months from baseline
Danish: Tabel 2: Andel af patienter med klinisk relevant forbedring af synsstyrken efter 6 måneder i forhold til baseline
English: Results are shown in Table 2 including supporting data from 62 LHON patients using Raxone in an Expanded Access Programme (EAP) and from 94 untreated patients in a Case Record Survey (CRS).
Danish: Resultaterne er vist i tabel 2, der desuden omfatter støttende data fra 62 patienter med LHON, der fik Raxone i et program for udvidet adgang (EAP), og fra 94 ubehandlede patienter i en journalundersøgelse (CRS).
English: No data are available in these populations.
Danish: Der foreligger ingen data hos disse patientgrupper.
English: Reports to be provided at the time of annual re-assessment
Danish: Der forelægges rapporter på tidspunktet for de årlige revurderinger.
English: No specific dose adjustment is required for the treatment of LHON in elderly patients.
Danish: Der behøves ingen specifik dosisjustering hos ældre ved behandling af LHON.
English: Pharmacotherapeutic group: Psychoanaleptics, Other psychostimulants and nootropics; ATC code: N06BX13
Danish: Farmakoterapeutisk klassifikation: Psykoanaleptika, Psykostimulantia og nootropika; ATC-kode: N06BX13
English: Raxone is not expected to affect your ability to drive or use machines.
Danish: Raxone forventes ikke at påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: One patient in the placebo group presented with ongoing spontaneous recovery of vision at baseline.
Danish: Hos én patient i placebogruppen var synet i spontan bedring ved baseline.
English: Studies in rats have shown that idebenone is excreted into maternal milk.
Danish: Forsøg med rotter har vist, at idebenon udskilles i moderdyrets mælk.
English: Doses up to 2250 mg/day have been administered in clinical studies showing a safety profile consistent with that reported in section 4.8.
Danish: I de kliniske undersøgelser er anvendt doser på op til 2.250 mg dagligt med en sikkerhedsprofil svarende til den, der angives i punkt 4.8.
English: A post-hoc responder analysis was performed in RHODOS evaluating the proportion of patients who had a clinically relevant recovery of VA from baseline in at least one eye, defined as either: (i) improvement in VA from unable to read a single letter to able to read at least 5 letters on the ETDRS chart; or (ii) improvement in VA by at least 10 letters on the ETDRS chart.
Danish: I RHODOS udførtes en post hoc-responderanalyse til bestemmelse af den andel af patienterne, der fik klinisk relevant genvinding af synsstyrken fra baseline i mindst ét øje, defineret som enten: (i) en synsstyrkeforbedring fra ikke at kunne læse ét bogstav til at kunne læse mindst fem bogstaver på ETDRS-tavlen, eller (ii) en synsstyrkeforbedring på mindst 10 bogstaver på ETDRS-tavlen.
English: In vivo idebenone is a mild inhibitor of CYP3A4.
Danish: In vivo er idebenon en mild hæmmer af CYP3A4.
English: - It is caused by a problem with your genes (called a “genetic mutation”) that affects the ability of cells in the eye to produce the energy they need to work normally, so they become inactive.
Danish: - Den skyldes et problem med generne (en genmutation), der nedsætter øjencellernes evne til at producere den energi, de behøver for at virke normalt.
English: The main secondary endpoint “change in best VA” was measured as the difference between best VA in either the left or right eye at 24 weeks compared to baseline (Table 1).
Danish: Det vigtigste sekundære endepunkt "ændring i bedste synsstyrke" blev målt som forskellen mellem bedste synsstyrke i enten venstre eller højre øje ved 24 uger og baseline (tabel 1) .
English: Due to the high first-pass effect, the plasma concentrations of idebenone were generally only measurable up to 6 hours after oral administration of 750 mg Raxone, given either as a single oral dose or after repeated (14 days) t.i.d dosing.
Danish: På grund af den store first pass-effekt var plasmakoncentrationerne af idebenon sædvanligvis kun målelige op til seks timer efter oral administration af 750 mg Raxone, enten som en enkelt oral dosis eller gentagen dosering tre gange dagligt i 14 dage.
English: Metabolism occurs by means of oxidative shortening of the side chain and by reduction of the quinone ring and conjugation to glucuronides and sulphates.
Danish: Metabolismen sker ved oxidativ afkortning af sidekæden, reduktion af quinonringen og konjugering til glukuronider og sulfater.
English: CARTONS/ HDPE BOTTLE LABEL
Danish: KARTON/ETIKET PÅ HDPE-FLASKE
English: However, the change in colour could mean that you have problems with your kidneys or bladder.
Danish: Farveændringerne kan dog skyldes problemer med nyrerne eller blæren.
English: This effect is harmless, not associated with haematuria, and does not require any adaptation of dose or discontinuation of treatment.
Danish: Denne virkning er harmløs, er ikke forbundet med hæmaturi og kræver ingen dosistilpasning eller seponering.
English: On repeat dosing, maximum plasma concentrations of idebenone are reached on average within 1 hour (median 0.67 h range: 0.33-2.00 h).
Danish: Ved gentagen dosering nås maksimal plasmakoncentration af idebenon i gennemsnit inden for en time (medianværdi 0,67 timer med variationsbredden: 0,33-2,00 timer).
English: Data from in vitro studies have demonstrated that idebenone and its metabolite QS10 do not exert systemic inhibition of cytochrome P450 isoforms CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4 at clinically relevant concentrations of idebenone or QS10.
Danish: Data fra in vitro-undersøgelser har vist, at idebenon og dets metabolit QS10 ikke systemisk hæmmer cytokrom P450-isoformerne CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 eller 3A4 ved klinisk relevante koncentrationer af idebenon eller QS10.
English: In phase I pharmacokinetic studies, proportional increases in plasma concentrations of idebenone were observed for doses from 150 mg to 1050 mg.
Danish: I fase I-undersøgelser af farmakokinetik iagttoges proportionalt stigende plasmakoncentrationer af idebenon ved doser fra 150 mg til 1.050 mg.
English: The safety and efficacy of Raxone in LHON patients under 12 years of age have not yet been established.
Danish: Raxones sikkerhed og virkning ved LHON hos patienter under 12 år er endnu ikke klarlagt.
English: Food increases the bioavailability of idebenone by approximately 5-7-fold and therefore, Raxone should always be administered with food.
Danish: Ved fødeindtagelse øges biotilgængeligheden af idebenon med en faktor 5-7, hvorfor Raxone altid skal gives sammen med et måltid.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Detaljeret information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for indsendelse af PSUR´er for dette lægemiddel fremgår af listen over EUreferencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EC, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu .
English: Very common (may affect more than 1 in 10 people): - nasopharyngitis (cold) - cough
Danish: Meget almindelig (kan forekomme hos mere end 1 ud af 10 behandlede) - forkølelse (nasofaryngitis) - hoste
English: In RHODOS a total of 85 LHON patients, 14-66 years of age, with any of the 3 primary mtDNA mutations (G11778A, G3460A or T14484C) and disease duration of not more than 5 years were enrolled.
Danish: I RHODOS indgik i alt 85 patienter med LHON i alderen 14-66 år med en vilkårlig af de tre primære mtDNA-mutationer (G11778A, G3460A eller T14484C) og en sygdomsvarighed på højst 5 år.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle after ‘EXP'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på etiketten og på kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Idebenone shows a high first pass metabolism resulting in conjugates of idebenone (glucuronides and sulphates (IDE-C)) and the Phase I metabolites QS10, QS6, and QS4 as well as their corresponding Phase II metabolites (glucuronides and sulphates (QS10+QS10-C, QS6+QS6-C, QS4+QS4-C)).
Danish: Idebenon undergår høj first pass-metabolisme, der resulterer i konjugater af idebenon (glukuronider og sulfater (IDE-C)) og i fase I-metabolitterne QS10, QS6 og QS4 samt de tilsvarende fase II-metabolitter (glukuronider og sulfater (QS10+QS10-C, QS6+QS6-C, QS4+QS4C)).
English: Raxone has no or negligible influence on the ability to drive and use machines.
Danish: Raxone påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Table 1: RHODOS: Best recovery of VA and change in best VA from baseline to week 24
Danish: Tabel 1: RHODOS: Bedste genvinding af synsstyrke og ændring i bedste synsstyrke fra baseline til uge 24
English: Common (may affect up to 1 in 10 people): - diarrhoea (mild to moderate that usually does not require discontinuation of treatment) - back pain
Danish: Almindelig (kan forekomme hos indtil 1 ud af 10 behandlede): - diarré (let eller moderat, der sædvanligvis ikke kræver, at behandlingen standses) - rygsmerter
English: Idebenone may inhibit P-glycoprotein (p-gp) with possible exposure increases of e.g. dabigatran etexilate, digoxin or aliskiren.
Danish: Idebenon kan hæmme P-glykoprotein (p-gp) med deraf følgende mulig øget eksponering for f.eks. dabigatranetexilat, digoxin eller aliskiren.
English: CRS-untreated (N=94)
Danish: CRS-ubehandlede (N=94)
English: Raxone may make your urine become reddish brown.
Danish: Raxone kan bevirke, at din urin bliver rødbrun.
English: This medicine should not be used in children This is because it is not known if Raxone is safe or works in patients under 12 years of age.
Danish: Dette skyldes, at det ikke vides, om Raxone er sikkert eller virker hos patienter under 12 år.
English: logMAR -0.135 ± 0.041 logMAR -0.071 ± 0.053 logMAR -0.064, 3 letters (-0.184; 0.055) p=0.291
Danish: logMAR -0,135 ± 0,041 logMAR -0,071 ± 0,053 logMAR -0,064, 3 bogstaver [-0,184; 0,055] p=0,291
English: Idebenone should only be administered to pregnant women or women of child-bearing age likely to become pregnant if it is considered that the benefit of the therapeutic effect outweighs any potential risk.
Danish: Til kvinder, der er gravide eller har sandsynlighed for at blive gravide, bør idebenon kun administreres, hvis den terapeutiske fordel skønnes at opveje en potentiel risiko.
English: logMAR -0.035 ± 0.046 logMAR 0.085 ± 0.060 logMAR -0.120, 6 letters (-0.255; 0.014) p=0.078
Danish: logMAR -0,035 ± 0,046 logMAR 0,085 ± 0,060 logMAR -0,120, 6 bogstaver [-0,255; 0,014] p=0,078
English: Excipients with known effect: Each film-coated tablet contains 46 mg of lactose (as monohydrate) and 0.23 mg of sunset yellow (E110).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 46 mg lactose (som monohydrat) og 0,23 mg sunset yellow (E110).
English: Therefore, caution should be exercised when prescribing Raxone to patients with hepatic or renal impairment.
Danish: Forsigtighed bør derfor udvises ved ordination af Raxone til patienter med nedsat lever- eller nyrefunktion.
English: Primary endpoint:
Danish: Primære endepunkt: