FrancophonIA/ELRC3.0 huggingface dataset:
English: For example in the morning at breakfast, with lunch at mid-day and with dinner in the evening.
Danish: - Tag tabletterne på samme klokkeslæt hver dag, f.eks. sammen med morgenmaden, frokosten og aftensmaden.
English: According to this biochemical mode of action, idebenone may re-activate viable-but-inactive retinal ganglion cells (RGCs) in LHON patients.
Danish: I henhold til denne biokemiske virkningsmekanisme kan idebenon tænkes at reaktivere levedygtige, men inaktive retinale ganglieceller (RGC) hos patienter med LHON.
English: Contents of the pack and other information What Raxone contains
Danish: Pakningsstørrelser og yderligere oplysninger Raxone indeholder:
English: White high-density polyethylene bottles with white polypropylene child-resistant tamper-evident twist-off caps containing 180 film-coated tablets.
Danish: Hvid flaske af HD-polyethylen med hvidt børnesikret, forseglet skruelåg af polypropylen, indeholdende 180 filmovertrukne tabletter.
English: Poly(vinyl alcohol) Talc
Danish: Polyvinylalkohol Talcum
English: After repeated administration Cmax and AUC of midazolam were increased by 28% and 34%, respectively, when midazolam was administered in combination with 300 mg idebenone t.i.d.
Danish: Efter gentagen administration forøgedes Cmax og AUC (arealet under kurven) for midazolam med henholdsvis 28 % og 34 %, når midazolam blev administreret samtidig med 300 mg idebenon 3 gange dagligt.
English: Raxone contains sunset yellow (E110) which may cause allergic reactions.
Danish: Raxone indeholder sunset yellow (E110), som kan forårsage allergiske reaktioner.
English: A pre-specified analysis in RHODOS determined the proportion of patients with an eye with baseline VA of ≤0.5 logMAR in whom the VA deteriorated to ≥1.0 logMAR.
Danish: En præspecificeret analyse i RHODOS fastlagde den andel af patienterne, hos hvem det ene øje havde en baseline-synsstyrke på ≤0,5 logMAR, der aftog til ≥1,0 logMAR.
English: Azotaemia, chromaturia
Danish: Azotæmi, kromaturi
English: The most commonly reported adverse reactions to idebenone are mild to moderate diarrhoea (usually not requiring the discontinuation of the treatment), nasopharyngitis, cough and back pain.
Danish: De oftest beskrevne bivirkninger med idebenon er let til moderat diarré (kræver sædvanligvis ikke seponering), nasofaryngitis, hoste og rygsmerter.
English: Non-interventional post-authorisation safety study (PASS): In order to further investigate the safety of Raxone in the treatment of LHON patients, the MAH should generate data based on an agreed protocol from a drug exposure registry of patients prescribed Raxone for the treatment of LHON in clinical practice.
Danish: Ikke-interventionel sikkerhedsundersøgelse efter markedsføring (PASS): Til nærmere undersøgelse af sikkerheden af Raxone til behandling af LHON skal indehaveren af markedsføringstilladelsen efter en godkendt protokol fremskaffe data fra et register over lægemiddeleksponering af patienter, der har fået ordineret Raxone til behandling af LHON i klinisk praksis.
English: Raxone contains lactose.
Danish: Raxone indeholder lactose.
English: The European Medicines Agency will review any new information which may become available every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger om lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: Nausea, vomiting, anorexia, dyspepsia
Danish: Kvalme, opkastning, anoreksi, dyspepsi
English: Therefore, a decision must be made whether to discontinue breast-feeding or to discontinue therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Danish: Det må derfor enten besluttes, at amning skal ophøre eller Raxone seponeres, idet fordelene ved amning for barnet og den terapeutiske fordel for moderen tages i betragtning.
English: Titanium dioxide Sunset yellow FCF (E110)
Danish: Titaniumdioxid Sunset yellow FCF (E110)
English: Data from a drug-drug interaction study in 32 healthy volunteers indicate that on the first day of oral administration of 300 mg idebenone t.i.d., the metabolism of midazolam, a CYP3A4 substrate, was not modified when both drugs were administered together.
Danish: Data fra et lægemiddel-lægemiddelinteraktionsstudie med 32 raske frivillige indikerer, at metabolismen af midazolam, et CYP3A4substrat, ikke blev modificeret på den første dag med oral administration af 300 mg idebenon 3 gange dagligt, når begge lægemidler blev administreret samtidigt.
English: Tel: +49 (0) 7621 1690 200
Danish: Tlf.: +49 (0)7621 1690 200
English: The metabolites of idebenone are coloured and may cause chromaturia, i.e. a reddish-brown discoloration of the urine.
Danish: Metabolitterne af idebenon er farvede og kan medføre kromaturi i form af rødbrun misfarvning af urinen.
English: No data regarding a continuous treatment with idebenone beyond 6 months is available from controlled clinical trials.
Danish: Der foreligger ingen data fra kontrollerede kliniske undersøgelser om kontinuerlig behandling med idebenon i længere tid end 6 måneder.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Povidone K25
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium Povidon K25
English: Tablet film-coating: macrogol, poly(vinyl alcohol), talc, titanium dioxide, sunset yellow (E110).
Danish: Tabletovertræk: macrogol, polyvinylalkohol, talcum, titandioxid, sunset yellow (E110).
English: Unknown frequency (frequency cannot be estimated from the available data): - bronchitis - changes in blood test results: low level of white blood cells, or low level of red blood cells, or low level of platelets - increased cholesterol or fat in the blood -shown in tests - fits, feeling confused, seeing or hearing things that are not real (hallucinations), feeling excited,
Danish: Ikke kendt (kan ikke beregnes ud fra de foreliggende oplysninger) - bronkitis - ændrede resultater af blodprøver: lavt antal hvide blodlegemer, lavt antal røde blodlegemer eller lavt antal blodplader - forhøjet kolesterol eller fedtstof i blodet - påvises gennem prøver - krampeanfald, forvirring, opfattelse af at se eller høre ting, der ikke er virkelige
English: Magnesium stearate Colloidal silica
Danish: Magnesiumstearat Silica, kolloid
English: In clinical trials in Friedreich's Ataxia, 32 patients between the ages of 8 and 11 years and 91 patients between the ages of 12 and 17 years received idebenone at ≥ 900 mg/day for up to 42 months.
Danish: I kliniske undersøgelser ved Friedreichs ataksi fik 32 patienter i alderen 8-11 år og 91 patienter i alderen 12-17 år idebenon i en dosis ≥ 900 mg dagligt i op til 42 måneder.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, especially any of the following: - antihistamines to treat allergies (astemizole, terfenadine) - to treat heartburn (cisapride) - to treat muscle and speech tics associated with Tourette syndrome (pimozide) - to treat hearth rhythm disorders (quinidine) - to treat migraine (dihydroergotamine, ergotamine) - to put you to sleep called “anaesthetics” (alfentanil) - to treat inflamation in rheumatoid arthritis and psoriasis (cyclosporine) - to prevent the rejection of an organ transplant (sirolimus, tacrolimus) - to treat strong pain called “opioids” (fentanyl)
Danish: Fortæl det altid til lægen, hvis du bruger anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin, særligt hvis det drejer sig om noget af følgende: - antihistaminer til behandling af allergi (astemizol, terfenadin) - lægemidler til behandling af halsbrand (cisaprid) - lægemidler til behandling af muskulære og vokale tics ved Tourettes syndrom (pimozid) - lægemidler til behandling af hjerterytmeforstyrrelser (kinidin) - lægemidler til behandling af migræne (dihydroergotamin, ergotamin) - lægemidler, som får dig til at sove, kaldet ”anæstetiske” lægemidler (alfentanil) - lægemidler til behandling af betændelse i forbindelse med reumatoid artritis og psoriasis
English: Orange, round, biconvex film-coated tablet of 10 mm diameter, engraved with the Santhera logo on one side and ‘150' on the other side.
Danish: Orange, runde, bikonvekse, filmovertrukne tabletter, diameter 10 mm, med Santheras logo præget på den ene side og "150" på den anden side.
English: - Your doctor will prescribe Raxone to you only if the benefits of the treatment are greater than the risks to the unborn child. - Raxone may pass into the mother's milk.
Danish: - Lægen vil kun ordinere Raxone til dig, hvis fordelene ved behandlingen opvejer risiciene for det ufødte barn.
English: Hepatobiliary disorders Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gammalutamyltransferase increased, blood bilirubin increased, hepatitis
Danish: Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet alkalisk fosfatase i blodet, forhøjet laktatdehydrogenase i blodet, forhøjet gammaglutamyltransferase, forhøjet bilirubin i blodet, hepatitis
English: Following oral administration pharmacologically relevant concentrations of idebenone are detectable in the aqueous humor of the eye.
Danish: Efter oral administration kan der påvises farmakologisk relevante koncentrationer af idebenon i øjets kammervæske.
English: In order to further investigate the benefits of Raxone in the treatment of LHON patients, the MAH should conduct and submit the results of an external natural history controlled, open-label intervention study to assess the efficacy and safety of Raxone in the treatment of LHON patients, including long-term treatment.
Danish: Til nærmere undersøgelse af fordelene ved Raxone til behandling af LHON skal indehaveren af markedsføringstilladelsen udføre og forelægge resultaterne af en åben interventionsundersøgelse, hvor der anvendes en ekstern kontrolgruppe vedrørende spontanforløb, og hvor virkningen og sikkerheden af Raxone til behandling af LHON vurderes, herunder langtidsbehandling.
English: In this small subgroup of patients (n=8), 0 of 6 patients in the idebenone group deteriorated to ≥1.0 logMAR whereas 2 of 2 patients in the placebo group showed such a deterioration.
Danish: I denne lille undergruppe af patienter (n=8) var der hos 0 ud af 6 patienter i gruppen på idebenon forringelse til ≥1,0 logMAR,
English: In RHODOS and the EAP in LHON, a total of 3 patients between the ages of 9 and 11 years and 27 patients between the ages of 12 and 17 years received idebenone at 900 mg/day for up to 33 months.
Danish: I RHODOS og programmet til udvidet adgang (EAP) ved LHON fik i alt 3 patienter i alderen 9-11 år og 27 patienter i alderen 12-17 år idebenon i en dosis på 900 mg dagligt i op til 33 måneder.
English: Best recovery of VA (mean ± SE; 95%CI)
Danish: Bedste genvinding af synsstyrke (gennemsnit ± standardfejl, 95 % CI)
English: Patients with hepatic or renal impairment have not been investigated.
Danish: Der er ingen undersøgelser hos patienter med nedsat lever- eller nyrefunktion.
English: The primary endpoint “best recovery of visual acuity (VA)” was defined as the result from the eye experiencing the most positive improvement in VA from baseline to week 24 using ETDRS charts.
Danish: Det primære endepunkt "bedste genvinding af synsstyrke" blev defineret som resultatet for det øje, hvor forbedringen i synsstyrke fra baseline til uge 24 var bedst, bestemt med ETDRS-tavle.
English: If you stop taking Raxone
Danish: Hvis du holder op med at tage Raxone
English: Idebenone is used to treat vision impairment in adults and adolescents with an eye disease called Leber's Hereditary Optic Neuropathy (LHON).
Danish: Idebenon anvendes til behandling af synsnedsættelse hos voksne og unge med øjensygdommen Lebers hereditære opticus-neuropati (LHON).
English: If you forget to take Raxone
Danish: Hvis du har glemt at tage Raxone
English: Therefore, CYP3A4 substrates known to have a narrow therapeutic index such as alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus,
Danish: Derfor skal CYP3A4-substrater, som vides at have et snævert terapeutisk indeks, som f.eks. alfentanil, astemizol, terfenadin, cisaprid,
English: Each film-coated tablet contains 150 mg idebenone.
Danish: Hver filmovertrukken tablet indeholder 150 mg idebenon.
English: The safety of idebenone in pregnant women has not been established.
Danish: Sikkerheden af anvendelsen af Raxone under graviditet er ikke fastlagt.
English: Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber's Hereditary Optic Neuropathy (LHON) (see section 5.1).
Danish: Raxone er indiceret til behandling af synsnedsættelse hos unge og voksne patienter med Lebers hereditære opticus-neuropati (LHON) (se pkt.
English: Nervous system disorders Seizure, delirium, hallucinations, agitation, dyskinesia, hyperkinesia, poriomania, dizziness, headache, restlessness, stupor
Danish: Krampeanfald, delirium, hallucinationer, uro, dyskinesi, hyperkinesi, poriomani, svimmelhed, hovedpine, rastløshed, stupor
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg apotek spersonalet, hvordan du skal bortskaffe medicinrester.
English: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K25, magnesium stearate and colloidal silica.
Danish: Tabletkerne: Lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, povidon K25, magnesiumstearat, kolloid silica.
English: Whilst clinical trials experience in paediatrics with LHON is limited to patients of 14 years of age and above, pharmacokinetic data from population pharmacokinetic studies, which included paediatric Friedreich's Ataxia patients of age 8 years and above, did not reveal any significant differences in the pharmacokinetics of idebenone.
Danish: Data fra populationsfarmakokinetiske undersøgelser hos pædiatriske patienter med Friedreichs ataksi i alderen over 8 år viste imidlertid ingen væsentlige forskelle i farmakokinetikken af idebenon
English: Idebenone, a short-chain benzoquinone, is an anti-oxidant assumed to be capable of transferring electrons directly to complex III of the mitochondrial electron transport chain, thereby circumventing complex I and restoring cellular energy (ATP) generation under experimental conditions of complex I deficiency.
Danish: Idebenon er et kortkædet benzoquinon med antioxidativ virkning og antages at kunne overføre elektroner direkte til kompleks III i den mitokondrielle elektrontransportkæde og derved omgå kompleks I, idet det genetablerer produktionen af cellulær energi (ATP) ved eksperimentelt fremkaldt mangel på kompleks I. Ved LHON kan idebenon tilsvarende overføre elektroner direkte til kompleks III i elektrontransportkæden og derved omgå kompleks I, som berøres af alle de tre primære mtDNAmutationer, der er årsag til LHON, og genetablere ATP-produktionen i cellerne.
English: Raxone contains a substance called idebenone.
Danish: Raxone indeholder det aktive stof idebenon.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Raxone.
Danish: Raxone bør ikke anvendes af patienter med de sjældne arvelige sygdomme galaktoseintolerans, Lapp-lactasemangel eller glukose-/galaktosemalabsorption.
English: Other medicines and Raxone
Danish: Brug af anden medicin sammen med Raxone
English: In a single-visit observational follow-up study of RHODOS VA assessments from 58 patients obtained on average 131 weeks after discontinuation of treatment indicates that the effect of Raxone may be maintained.
Danish: At Raxones virkning kan tænkes at blive fastholdt, blev påvist i en opfølgende observationsundersøgelse til RHODOS, hvor der blev aflagt et enkelt besøg med synsstyrkebestemmelse hos 58 patienter gennemsnitligt 131 uger efter behandlingsophør.
English: Blood cholesterol increased, blood triglycerides increased
Danish: Metabolisme og ernæring Forhøjet kolesterolindhold i blodet, forhøjet triglyceridindhold i blodet
English: Contains lactose and sunset yellow (E110).
Danish: Indeholder lactose og sunset yellow (E110).
English: - The active substance is idebenone.
Danish: - Aktivt stof: idebenon.
English: Package leaflet: Information for the user Raxone 150 mg film-coated tablets idebenone
Danish: Indlægsseddel: Information til brugeren Raxone, filmovertrukne tabletter, 150 mg idebenon
English: Responders (N, %) 19 (30.6 %)
Danish: Respondere (N, %)
English: What you need to know before you take Raxone Do not take Raxone if you are allergic to idebenone or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for idebenon eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: Main secondary endpoint: Change in best VA (mean ± SE; 95% CI)
Danish: Ændring i bedste synsstyrke (gennemsnit ± standardfejl, 95 % CI)
English: Raxone 150 mg film-coated tablets idebenone
Danish: Raxone 150 mg filmovertrukne tabletter idebenon
English: What you need to know before you take Raxone 3.
Danish: Det skal du vide, før du begynder at tage Raxone Tag ikke Raxone
English: Raxone 150 mg film-coated tablets
Danish: Raxone 150 mg filmovertrukne tabletter
English: - Raxone film-coated tablets are orange, round tablets of 10 mm diameter, engraved with the
Danish: - Raxone filmovertrukne tabletter er orange, runde tabletter, diameter 10 mm, med Santheras logo præget på den ene side og "150" på den anden side.
English: - Raxone contains lactose (a type of sugar).
Danish: - Raxone indeholder sukkerarten lactose.
English: Core tablet
Danish: Tabletkerne
English: The following adverse reactions emerging from clinical trials in LHON patients or reported postmarketing in other indications are tabulated below.
Danish: LHON eller er indberettet efter markedsføring ved andre indikationer.
English: - This eye problem is inherited - this means it runs in families.
Danish: - Denne øjensygdom er arvelig.
English: or ergot alkaloids (ergotamine, dihydroergotamine) should be administered with caution in patients receiving idebenone.
Danish: cyclosporin, fentanyl, pimozid, quinidin, sirolimus, tacrolimus eller ergotalkaloider (ergotamin, dihydroergotamin), administreres med forsigtighed hos patienter, der får idebenon.
English: Raxone contains lactose and sunset yellow (E110)
Danish: Raxone indeholder lactose og sunset yellow (E110).
English: How to take Raxone
Danish: Sådan skal du tage Raxone
English: Agranulocytosis, anaemia, leukocytopenia, thrombocytopenia, neutropenia
Danish: Blod og lymfesystem Agranulocytose, anæmi, leukocytopeni, trombocytopeni, neutropeni
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Udslæt, pruritus
English: Chromaturia
Danish: Kromaturi
English: feeling restless, lacking energy - nausea, vomiting, loss of appetite, stomach ache - high levels of some liver enzymes in the body which mean you have liver problems - shown in tests, high levels of “bilirubin” - this can make your skin and the whites of your eyes look yellow, hepatitis - rash, itching - pain in extremity - high levels of nitrogen in the blood - shown in tests change in urine colour - generally feeling unwell
Danish: leverbetændelse - udslæt, kløe - smerter i arme og ben - højt kvælstofindhold i blodet (påvises ved prøver), ændret farve af urinen - generel utilpashed
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Tal med lægen eller apotekspersonalet, hvis der er mere, du vil vide om brugen af lægemidlet.
English: Caution is advised in treatment of patients with hepatic or renal impairment (see section 4.4).
Danish: Ved nedsat lever- eller nyrefunktion tilrådes forsigtighed (se pkt.
English: Taking this medicine
Danish: Brug af lægemidlet
English: EAP and CRS
Danish: Program for udvidet adgang (EAP) og journalundersøgelse (CRS)
English: - Raxone contains a colourant called “sunset yellow” (also called E110).
Danish: - Raxone indeholder farvestoffet sunset yellow (E110).
English: If you take more Raxone than you should
Danish: Hvis du har taget for meget Raxone
English: These reactions are usually short lived and go away within 5 to 15 days but could last up to 49 days.
Danish: Disse reaktioner er sædvanligvis kortvarige og forsvinder inden for 5-15 dage, men kan vare op til 49 dage.
English: Zeleris should not be administered by pregnant women.
Danish: Zeleris må ikke indgives af gravide kvinder.
English: The withdrawal period for meat from cattle treated with Zeleris is 56 days.
Danish: Tilbageholdelsestiden for kød fra kvæg, der behandles med Zeleris, er 56 dage.
English: This is a summary of the European public assessment report (EPAR) for Zeleris.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zeleris.
English: The full EPAR for Zeleris can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zeleris findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: In addition, in the first 48 hours after the injection, Zeleris was more effective than florfenicol alone in reducing the body temperature to below 39.5˚C.
Danish: I de første 48 timer efter indsprøjtningen var Zeleris desuden mere effektivt end florfenicol alene til at bringe kropstemperaturen under 39,5 ˚C.
English: The dose depends on the animal's weight and is given by injection under the skin in the neck area.
Danish: Dosis afhænger af dyrets vægt og gives ved injektion under huden i nakkeområdet.
English: In case of eye contact the affected area should be rinsed immediately with water.
Danish: Ved uforvarende kontakt med øjnene skal det berørte område omgående skylles med vand.
English: This means that the antibiotic may no longer work on bacteria infecting either animals or humans.
Danish: Det kan betyde, at antibiotikummet ikke længere virker mod bakterier, der smitter dyr eller mennesker.
English: Antibiotic resistance is the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth.
Danish: Antibiotikaresistens er bakteriers evne til at vokse i tilstedeværelse af et antibiotikum, der normalt ville dræbe dem eller hæmme deres vækst.
English: During injection of this product animals may show signs of moderate pain, such as movement of the head or neck.
Danish: Under indsprøjtning af dette produkt kan dyrene udvise tegn på moderat smerte såsom ved at bevæge hovedet eller nakken.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zeleris's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Zeleris opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: A success rate of 67% was achieved with Zeleris compared to 65% for florfenciol.
Danish: Der blev opnået en helbredelsesprocent på 67 % med Zeleris, sammenholdt med 65 % for florfenicol.
English: Cattle weighing more than 150 kg will need to have the dose divided and injected at more than one site.
Danish: Til kvæg med vægt over 150 kg må dosis opdeles og indsprøjtes mere end ét sted.
English: Zeleris was as effective as florfenicol alone in improving signs of the disease (based on behaviour and breathing) on day 7.
Danish: Zeleris var lige så effektivt som florfenicol alene til at give bedring i sygdomstegnene (baseret på adfærd og vejrtrækning) på dag 7.
English: As Zeleris contains an antibiotic it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance.
Danish: Da Zeleris indeholder et antibiotikum, at det vigtigt, at indlægssedlens anvisninger overholdes nøje for at minimere udviklingen af antibiotikaresistens.