FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies showed that Ocrevus was more effective than interferon beta-1a at reducing the number of relapses in patients with relapsing forms of multiple sclerosis.
Danish: Undersøgelser har vist, at Ocrevus var mere effektivt end interferon beta-1a til at reducere antallet af attakker hos patienter med attakvis multipel sklerose.
English: In two studies of 1,656 patients with relapsing forms of multiple sclerosis (RMS), the average number of relapses in patients treated with Ocrevus was about half that in patients treated with another medicine interferon beta-1a (0.16 versus 0.29 relapses per year).
Danish: I to undersøgelser af 1 656 patienter med attakvis multipel sklerose var det gennemsnitlige antal attakker hos patienter, der fik Ocrevus, ca. halvdelen af antallet hos patienter, der fik et andet lægemiddel (interferon beta-1a) (0,16 over for 0,29 attakker pr. år).
English: Ocrevus treatment also provided some benefit in patients with primary progressive multiple sclerosis, a condition for which treatments are urgently needed.
Danish: Behandlingen med Ocrevus var også gavnlig for patienter med primær progressiv multipel sklerose, der er en tilstand, som kræver øjeblikkelig behandling.
English: Ocrevus is given as an infusion (drip) into a vein.
Danish: Ocrevus gives som infusionsvæske (drop) i en blodåre.
English: For more information about treatment with Ocrevus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ocrevus, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Ocrevus?
Danish: Hvilke risici er der forbundet med Ocrevus?
English: These white blood cells play a role in multiple sclerosis by attacking the sheaths around the nerves in the brain and spinal cord, causing inflammation and damage.
Danish: Disse hvide blodlegemer spiller en rolle i multipel sklerose ved at angribe det beskyttende lag, der omgiver nerverne i hjernen og rygmarven, hvilket forårsager betændelse og skade.
English: By targeting the B cells, Ocrevus helps to reduce their activity and thereby relieves symptoms or slows down the worsening of the disease.
Danish: Eftersom Ocrevus er rettet mod B-cellerne, hjælper stoffet med at reducere deres aktivitet og lindrer derved symptomerne eller forsinker forværringen af sygdommen.
English: Ocrevus is a medicine for treating multiple sclerosis - an inflammatory disease of the nervous system that causes symptoms such as weakness, difficulty walking and problems with vision.
Danish: Ocrevus er et lægemiddel til behandling af multipel sklerose, der er en betændelsessygdom i nervesystemet, som medfører symptomer som f.eks. svaghed, gangbesvær og synsforstyrrelser.
English: • adults with primary progressive multiple sclerosis (PPMS), where symptoms get steadily worse over time.
Danish: • voksne med tidlig primær progressiv multipel sklerose, hvor symptomerne forværres med tiden.
English: Studies have shown that Ocrevus is effective at reducing the number of relapses and it can also reduce the worsening of symptoms in some patients.
Danish: Undersøgelser har vist, at Ocrevus reducerer antallet af attakker, og at det også kan reducere forværringen af sygdommen hos nogle patienter.
English: For the full list of side effects reported with Ocrevus, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ocrevus fremgår af indlægssedlen.
English: For practical information about using Ocrevus, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ocrevus, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Ocrevus used?
Danish: Hvordan anvendes Ocrevus?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ocrevus have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ocrevus.
English: What benefits of Ocrevus have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ocrevus?
English: How does Ocrevus work?
Danish: Hvordan virker Ocrevus?
English: • adults with relapsing forms of multiple sclerosis (RMS), where the patient has flare-ups (relapses)
Danish: • voksne med attakvis multipel sklerose, hvor patienten oplever attakker efterfulgt af perioder med mildere eller ingen symptomer
English: Older patients (≥ 65 years old)
Danish: Ældre patienter (≥ 65 år)
English: Other effects should be treated symptomatically.
Danish: Andre virkninger bør behandles symptomatisk.
English: After opening: 1 year.
Danish: Efter åbning: 1 år.
English: Therefore, steroid replacement may be necessary in these patients.
Danish: Steroidsubstitution kan derfor være nødvendig hos disse patienter.
English: Date of first authorisation: 28 April 2004 Date of last renewal: 28 April 2009
Danish: Dato for første markedsføringstilladelse : 28 april 2004 Dato for seneste genregistrering : 28 april 2009
English: For information on the product, please contact:
Danish: For information om produktet, kontakt:
English: Ask your doctor for advice.
Danish: Spørg Deres læge til råds.
English: Safety data are based on literature (mainly retrospective studies).
Danish: Sikkerhedsdata er baseret på litteraturen (fortrinsvis retrospektive forsøg).
English: Treatment should be initiated and followed by a suitably experienced specialist.
Danish: Behandling bør indledes og følges af en specialist med passende erfaring.
English: 2.800 04010 Sermoneta (Latina) Italy or
Danish: 2.800 04010 Sermoneta (Latina) Italien eller
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til andre websteder om sjældne sygdomme, og hvordan de behandles.
English: EXP After opening: 1 year
Danish: EXP Efter åbning: 1 år
English: There were recurrences in 40% of children; the survival rate at 5 years was 49%.
Danish: Der var tilbagefald hos 40 % af børnene; overlevelsesraten efter 5 år var 49 %.
English: Overall, the disease-free interval was 7 months (2 to 16 months).
Danish: Totalt var det sygdomsfrie interval 7 måneder (2 til 16 måneder).
English: If you are pregnant or planning to become pregnant, tell your doctor.
Danish: Hvis De er gravid eller planlægger at blive gravid, skal De fortælle det til Deres læge.
English: The target plasma concentration is usually reached within a period of 3 to 5 months.
Danish: Målplasmakoncentrationen nås normalt inden for en periode på 3-5 måneder.
English: The experience in patients in this age group is very limited.
Danish: Erfaringen med patienter i denne aldersgruppe er meget begrænset.
English: Hypothyroidism and growth retardation may be also observed.
Danish: Hypotyroidisme og forsinket vækst kan også observeres.
English: Frequency Not Known
Danish: Hyppighed ikke kendt
English: Autoimmune hepatitis has been reported in 7 % of patients with no other information on mechanism.
Danish: Autoimmun hepatitis er blevet rapporteret hos 7 % af patienterne uden anden information om mekanismen.
English: In order to find the optimal dose for you, your doctor will monitor regularly the levels of Lysodren in your blood.
Danish: For at finde den optimale dosis til Dem vil Deres læge regelmæssigt overvåge niveauet af Lysodren i Deres blod.
English: A case of cholestatic hepatitis has been reported.
Danish: Et tilfælde af cholestatisk hepatitis er rapporteret.
English: A starting dose higher than 6 g/day is generally not recommended.
Danish: En startdosis på mere end 6 g dagligt anbefales generelt ikke.
English: If you accidentally miss a dose, just take the next dose as scheduled.
Danish: Hvis De ved et uheld springer en dosis over, så tag bare den næste dosis som planlagt.
English: After intravenous administration, 25% of the dose was excreted as metabolites within 24 hours.
Danish: Efter intravenøs administration blev 25 % af dosis udskilt som metabolitter inden for 24 timer.
English: They are bisected on one side and impressed "BL" over "L1" on the other side.
Danish: De har delekærv på den ene side og er præget med "BL" over "L1" på den anden side.
English: In terms of overall survival, four studies conclude that mitotane treatment does not increase the survival rate whereas five find an increase in the survival rate.
Danish: Udtrykt i total overlevelse konkluderer fire undersøgelser, at mitotanbehandling ikke øger overlevelsesraten, medens fem finder en øgning i overlevelsesraten.
English: Leucopoenia has been reported in 8 to 12 % of patients.
Danish: Leukopeni er blevet rapporteret hos 8 til 12 % af patienterne.
English: Ambulatory patients should be warned not to drive or use machines.
Danish: Ambulante patienter bør advares om ikke at køre eller betjene maskiner.
English: France Tel: + 33 1 40 33 93 14
Danish: Tlf.: + 33 1 40 33 93 14
English: Its biochemical mechanism of action is unknown.
Danish: Dens biokemiske virkningsmekanisme er ukendt.
English: Gastrointestinal disorders are the most frequently reported (10 to 100 % of patients) and are reversible when the dose is reduced.
Danish: Gastrointestinale forstyrrelser er oftest rapporteret (10 til 100 % af patienterne) og er reversible, når dosis bliver reduceret.
English: Mitotane has not been studied in a comprehensive clinical development program.
Danish: Mitotan er ikke blevet undersøgt i et omfattende klinisk udviklingsprogram.
English: However, this result should be cautiously taken since the examination of the mitotane effects was not the primary endpoint of the study.
Danish: Dette resultat skal dog tages med forbehold, eftersom undersøgelse af mitotans virkninger ikke var forsøgets primære endepunkt.
English: Pack size of 1 bottle.
Danish: Pakningsstørrelse med 1 flaske.
English: Microcrystalline cellulose (E 460) Macrogol 3350
Danish: Mikrokrystallinsk cellulose (E 460) Macrogol 3350
English: Frequency groupings are defined according to the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Danish: Frekvensgrupperne er defineret efter følgende konvention: Meget almindelig (≥1/10), Almindelig (≥1/100 til <1/10), Ikke almindelig (≥1/1.000 til <1/100), Sjælden (≥1/10.000 til <1/1.000), Meget sjælden(<1/10.000), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Nervous system undesirable effects occur in approximately 40 % of patients.
Danish: Bivirkninger ved nervesystemet forekommer hos cirka 40 % af patienter.
English: Lysodren with food and drink
Danish: Brug af Lysodren sammen med mad og drikke
English: Do not take a double dose to make up for the forgotten one.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: If no clinical benefits are observed after 3 months at optimal dose, treatment should be permanently discontinued.
Danish: Hvis der ikke ses kliniske fordele efter 3 måneder ved optimal dosering, bør behandlingen afbrydes permanent.
English: 63800 COURNON D'AUVERGNE FRANCE
Danish: 63800 COURNON D'AUVERGNE FRANKRIG
English: Lysodren should be given to pregnant women only if clearly needed and if the clinical benefit clearly outweighs any potential risk to the foetus.
Danish: Lysodren bør kun gives til gravide kvinder, hvis der er klart behov for det, og hvis den kliniske fordel klart opvejer enhver potentiel risiko for fostret.
English: Opportunistic mycosis
Danish: Opportunistisk mykose
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX23
Danish: Farmakoterapeutisk gruppe: Antineoplastiske midler ATC kode: L01XX23
English: In case of mild toxicity, the dose should be reduced until the maximum tolerated dose is attained.
Danish: I tilfælde af let toksicitet bør dosis reduceres, indtil den maksimalt tolererede dosis er nået.
English: More than 80 % of patients treated with mitotane have shown at least one type of undesirable effect.
Danish: Mere end 80 % af patienter behandlet med mitotan har udvist mindst én type bivirkning.
English: Monitoring should be more frequent (e.g. every week) when a high starting dose has been used.
Danish: Monitorering bør ske hyppigere (f.eks. hver uge), når der er anvendt en høj startdosis.
English: Some of these effects (anorexia) may constitute the hallmark of initial central nervous system impairment.
Danish: Nogle af disse virkninger (anoreksi) kan udgøre stemplet for initial forringelse af centralnervesystemet.
English: Treatment with Lysodren should be continued as long as clinical benefits are observed.
Danish: Behandling med Lysodren bør fortsætte, så længe der ses kliniske fordele.
English: Skin rashes which have been reported in 5 to 25 % of patients do not seem to be dose related.
Danish: Hududslæt, der er blevet rapporteret hos 5 til 25 % af patienterne, synes ikke at være dosisrelaterede.
English: Mitotane was given alone or combined with chemotherapy with various agents.
Danish: Mitotan blev givet alene eller kombineret med kemoterapi med forskellige stoffer.
English: Consequently, despite a constant dose, mitotane levels may increase.
Danish: På trods af konstant dosering kan mitotan niveauerne derfor øges.
English: Animal studies with similar substances have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier med lignende stoffer har påvist reproduktionstoksicitet (se pkt.
English: The patient should be followed closely, taking into account that impairment is reversible, but given the long half-life and the lipophilic nature of mitotane, it may take weeks to return to normal.
Danish: Patienten bør følges nøje, idet man tager højde for, at svækkelsen er reversibel, men den lange halveringstid og mitotans lipofile natur taget i betragtning, kan det tage uger at vende tilbage normal tilstand.
English: Adverse reactions listed below are classified according to frequency and system organ class.
Danish: Bivirkninger, der er nævnt herunder, er opdelt efter frekvens og organklasse.
English: Lysodren is an antitumoral medicine.
Danish: Lysodren er et antitumormiddel.
English: Prolonged bleeding time appears a frequent finding (90 %): although the exact mechanism of such an effect is unknown and its relation with mitotane or with the underlying disease is uncertain, it should be taken into account when surgery is considered.
Danish: Forlænget blødningstid forekommer at være et ofte forekommende fund (90 %): Selvom den nøjagtige mekanisme ved sådan en virkning er ukendt, og dens forbindelse med mitotan eller med den underliggende lidelse er usikker, bør det tages i betragtning, når der overvejes operation.
English: Autopsy data from patients show that mitotane is found in most tissues of the body, with fat as the primary site of storage.
Danish: Obduktionsdata fra patienter viser, at mitotan bliver fundet i de fleste af kroppens væv, med fedt som det primære sted for opbevaring.
English: Therefore, you should tell your doctor if you are using medicines containing any of the following active substances: - warfarin or other anticoagulants (blood thinners), used to prevent blood clots.
Danish: De bør derfor informere Deres læge, hvis De bruger lægemidler, der indeholder et af følgende aktive stoffer: - Warfarin eller andre antikoagulantia (blodfortyndende midler), der bruges til at forebygge blodpropper.
English: Due to the prolonged half-life, significant serum concentrations may persist for weeks after cessation of therapy.
Danish: På grund af den øgede halveringstid kan signifikante serumkoncentrationer persistere i uger efter seponering af behandlingen.
English: Because of an increased risk of acute adrenocortical insufficiency, patients should be instructed to contact their physician immediately if injury, infection, or any other concomitant illness occurs.
Danish: På grund af en øget risiko for akut adrenocortical insufficiens, bør patienterne informeres om at kontakte deres læge med det samme, hvis der forekommer skade, infektion eller nogen anden samtidig sygdom.
English: Treatment should be initiated at 1.5 to 3.5 g/m2/day in children and adolescents with the objective of reaching 4 g/m2/day.
Danish: Behandling bør indledes med 1,5 til 3,5 g/m2/dag hos børn og unge med det formål at nå 4 g/m2/dag.
English: Available clinical information comes mainly from published data in patients with inoperable or metastatic adrenal carcinoma.
Danish: Tilgængelig klinisk information kommer hovedsagelig fra offentliggjorte data hos patienter med inoperabelt eller metastatisk adrenalt carcinom.
English: Although no specific information on pharmacodynamic interactions in the central nervous system is available, this should be borne in mind when co-prescribing medicinal products with central nervous system depressant action.
Danish: Selvom der ikke foreligger specifik information om farmakodynamiske interaktioner i centralnervesystemet, bør dette holdes in mente, når der ordineres lægemidler med depressiv virkning på centralnervesystemet.
English: Table 1: Frequency of adverse reactions identified from literature data
Danish: Tabel 1: Bivirkningsfrekvens identificeret ud fra litteraturdata:
English: No unchanged mitotane has been found in bile or in urine, where o,p'-DDA predominates, together with several of its hydroxylated metabolites.
Danish: Intet uændret mitotan er blevet fundet i galde eller i urin, hvor o,p'-DDA prædominerer, sammen med adskillige af dens hydroxylerede metabolitter.
English: Therefore, the possibility of mitotane-induced liver damage cannot be excluded.
Danish: Muligheden for mitotan-induceret leverskade kan derfor ikke udelukkes.
English: Lysodren should preferably be taken during meals containing fat-rich food such as milk, chocolate, oil.
Danish: Lysodren bør fortrinsvis tages i forbindelse med måltider med madvarer med et højt indhold af fedt, såsom mælk, chokolade, olie.
English: However, dichlorodiphenyltrichlorethane (DDT) and other polychlorinated biphenyl analogues are known to have deleterious effects on fertility, pregnancy and development, and mitotane could be expected to share these properties.
Danish: Dichlordiphenyltrichlorethan (DDT) og andre polyklorinerede bifenylanaloger er imidlertid kendt for at have skadelige virkninger på fertilitet, graviditet og udvikling, og mitotan kunne forventes at dele disse egenskaber.
English: The effect of Lysodren on non functional adrenal cortical carcinoma is not established
Danish: Virkningen af Lysodren på ikke-funktionelt adrenokortikalt karcinom er ikke fastslået.
English: Dose may be reduced after 2 or 3 months according to the mitotane plasma levels or in case of serious toxicity.
Danish: Dosis kan nedsættes efter 2 eller 3 måneder i henhold til plasma-mitotanniveauerne eller i tilfælde af alvorlig toksicitet.
English: The paediatric posology of mitotane has not been well characterised but appears equivalent to that of adults after correction for body surface.
Danish: Den pædiatriske dosering af mitotan er ikke blevet særlig godt karakteriseret, men synes at være den samme som for voksne efter korrektion for legemsoverflade.
English: Oral use.
Danish: Oral brug.
English: Risk of adrenal insufficiency: All patients with non functional tumour and 75% of patients with functional tumour show signs of adrenal insufficiency.
Danish: Risiko for binyrebarkinsufficiens: Alle patienter med nonfunktionel tumor og 75 % af patienter med funktionel tumor viser tegn på binyrebarkinsufficiens.
English: Your doctor may decide to stop treatment with Lysodren temporarily or to lower the dose if you experience certain side effects.
Danish: Deres læge kan beslutte at stoppe behandlingen med Lysodren for en tid eller at sænke dosis, hvis De oplever visse bivirkninger.
English: Blood and lymphatic system disorders: All blood cells can be affected with mitotane treatment.
Danish: Blod og lymfesystem: Alle blodceller kan påvirkes af behandling med mitotan.
English: These symptoms may reveal complications for which specific medication could be appropriate.
Danish: Disse symptomer kan være tegn på komplikationer, som kan behandles med bestemte lægemidler.
English: Tell your doctor immediately if you have taken accidentally more Lysodren than you should or if a child has accidentally swallowed some.
Danish: Underret straks Deres læge, hvis De ved et uheld har taget flere Lysodren, end De skulle, eller hvis et barn ved et uheld har slugt nogle.
English: Tel: + 33 1 40 33 93 14 medinfo-rd@hra-pharma.com
Danish: HRA Pharma Rare Diseases Tlf.: + 33 1 40 33 93 14 medinfo-rd@hra-pharma.com
English: Mitotane apparently causes increased formation of 6-betahydroxy cholesterol.
Danish: Mitotan medfører tilsyneladende øget formation af 6-beta-hydroxyl kolesterol.
English: Bottle of 100 tablets.
Danish: Flaske med 100 tabletter.
English: In addition, in both studies, in some patients, the plasma mitotane levels continued to rise despite maintenance or a decrease of the daily dose of mitotane.
Danish: Derudover fortsatte, i begge undersøgelser, hos nogle patienter, plasmamitotanniveauer med at stige på trods af vedligeholdelse eller en nedgang i den daglige dosis mitotan.
English: Like all medicines, Lysodren can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Non-clinical data on the general toxicity of mitotane is limited.
Danish: Ikke-kliniske data på den almene toksicitet af mitotan er begrænset.
English: This medicinal product should not be handled by persons other than the patient and his/her caregivers, and especially not by pregnant women.
Danish: Dette lægemiddel bør ikke håndteres af personer udover patienten og hans/hendes plejepersonale og især ikke af gravide kvinder.
English: Shock, severe trauma or infection: Mitotane should be temporarily discontinued immediately following shock, severe trauma or infection, since adrenal suppression is its prime action.
Danish: Shock, svært traume eller infektion: Mitotan bør temporært afbrydes umiddelbart efter shock, svært traume eller infektion, da adrenal suppression er dets primære virkning.
English: Available data suggest that mitotane modifies the peripheral metabolism of steroids and that it also directly suppresses the adrenal cortex.
Danish: Tilgængelige data antyder, at mitotan modificerer steroiders perifere metabolisme, og at det også direkte undertrykker den adrenale cortex.
English: If serious adverse reactions occur, such as neurotoxicity, treatment with mitotane may need to be temporarily interrupted.
Danish: Hvis der forekommer alvorlige bivirkninger, såsom neurotoksicitet, kan det blive nødvendigt midlertidig at afbryde behandlingen med mitotan.
English: Dose adjustments, monitoring and discontinuation
Danish: Dosisjusteringer, monitorering og seponering
English: Following discontinuation of mitotane treatment, it is slowly released from storage sites in fat, leading to reported terminal plasma half-lives ranging from 18 to 159 days.
Danish: Efter seponering af behandling med mitotan, bliver det langsomt frigjort fra opbevaringssteder i fedt, ledende til rapporterede terminale plasmahalveringstider strækkende sig fra 18 til 159 dage.
English: To be handled only by patients, or caregivers wearing gloves.
Danish: Må kun håndteres af patienter eller sundhedspersonale med handsker.
English: Liver function tests (alanine transaminase [ALT], aspartate transaminase [AST], bilirubin levels) should be periodically monitored, especially during the first months of treatment or when it is necessary to increase the dose.
Danish: Leverfunktionstest (alanintransaminase [ALAT], aspartattransaminase [ASAT], bilirubin) bør monitoreres jævnligt, især i de første måneder af behandlingen, eller når det er nødvendigt at sætte dosis op.