FrancophonIA/ELRC3.0 huggingface dataset:
English: Indeed, neurologic toxicity has been associated with levels above 20 mg/l and therefore this threshold should not be reached.
Danish: Neurologisk toksicitet er set i forbindelse med niveauer over 20 mg/l, og derfor bør denne tærskelværdi ikke nås.
English: The threshold of 20 mg/l was reached for cumulative amounts of mitotane of approximately 500 g. In another study, 3 patients with adrenal carcinoma received Lysodren according to a precise protocol allowing fast introduction of a high dose if the product was well tolerated: 3 g (as 3 intakes) on day 1, 4.5 g on day 2, 6 g on day 3, 7.5 g on day 4 and 9 g on day 5.
Danish: Tærsklen på 20 mg/l blev nået for kumulative mængder mitotan på cirka 500 g. I et andet studie fik 3 patienter med adrenalt carcinom Lysodren i henhold til en præcis protokol, der tillod hurtig introduktion af en høj dosis, hvis produktet blev godt tolereret: 3 g (som 3 indtagelser) på dag 1, 4,5 g på dag 2, 6 g på dag 3, 7,5 g på dag 4 og 9 g på dag 5.
English: INSTRUCTIONS FOR USE
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: Clinical information comes mainly from a prospective trial (n= 24 patients) in children and adolescents aged at diagnosis from 5 months to 16 years (median age: 4 years) who had an unresectable primary tumour or who presented a tumour recurrence or a metastasic disease; most of the children (75%) presented with endocrine symptoms.
Danish: Klinisk information kommer hovedsagelig fra et prospektivt forsøg (n= 24 patienter) hos børn og unge, som ved diagnose var i alderen fra 5 måneder til 16 år (aldersmedian: 4 år), der havde en ikkeresektérbar primærtumor, eller som udviste et tumor tilbagefald eller en metastatisk sygdom; de fleste af børnene (75 %) fremstod med endokrine symptomer.
English: In a study performed in 8 patients with adrenal carcinoma treated with 2 to 3 g daily of mitotane, a highly significant correlation was found between plasma mitotane concentration and the total mitotane dose.
Danish: I et studie udført med 8 patienter med adrenalt carcinom behandlet med mitotan 2 til 3 g dagligt, blev der fundet en yderst signifikant korrelation mellem plasma-mitotankoncentrationen og den totale mitotandosis.
English: Your doctor may prescribe you some hormonal treatment (steroids) while you are taking Lysodren.
Danish: Deres læge kan ordinere hormonbehandling (steroider), når De tager Lysodren.
English: There was a positive linear correlation between the cumulative dose of Lysodren and the plasma levels of mitotane.
Danish: Der var en positiv lineær korrelation mellem den kumulative dosis af Lysodren og plasmaniveauerne af mitotan.
English: If it is urgent to control Cushing's symptoms in highly symptomatic patients, higher starting doses between 4 - 6 g per day could be necessary and daily dose increased more rapidly (e.g. every week).
Danish: Hvis det er vigtigt at behandle Cushing-symptomer hos patienter med mange symptomer, kan højere startdoser mellem 4-6 g dagligt være nødvendigt, og den daglige dosis skal øges hurtigere (f.eks. hver uge).
English: Your doctor may start treatment at higher doses such as 4 to 6 g (8 to 12 tablets).
Danish: Deres læge kan starte behandlingen med højere doser, som f.eks. 4 til 6 g (8 til 12 tabletter).
English: Lysodren has a major influence on the ability to drive and use machines.
Danish: Lysodren påvirker i væsentlig grad evnen til at føre og betjene maskiner.
English: Other undesirable central nervous effects have been reported in literature such as memory defects, aggressiveness, central vestibular syndrome, dysarthria, or Parkinson syndrome.
Danish: Andre centralnervøse bivirkninger er blevet rapporteret i litteraturen såsom hukommelsesdefekter, aggressivitet, centralt vestibulært syndrom, dysarthri eller Parkinson syndrom.
English: You must not use Lysodren with medicines containing spironolactone, often used as a diuretic for heart, liver or kidney diseases.
Danish: De må ikke bruge Lysodren sammen med lægemidler, som indeholder spironolacton, der ofte bruges som et vanddrivende middel til hjerte-, lever- og nyresygdomme.
English: In two of the 3 patients, plasma levels of more than 14 mg/l were achieved within 15 days and in one of them levels above 20 mg/l were achieved within approximately 30 days.
Danish: Hos to af de 3 patienter blev plasmaniveauer på mere end 14 mg/l opnået indenfor 15 dage og hos en af dem, blev niveauer over 20 mg/l opnået indenfor cirka 30 dage.
English: The genotoxic and carcinogenic potential of mitotane has not been investigated.
Danish: Det genotoksiske og carcinogene potentiale ved mitotan er ikke blevet undersøgt.
English: Lysodren may interfere with several medicines.
Danish: Lysodren kan påvirke adskillige lægemidler.
English: At high doses and after prolonged utilization, brain function impairment can occur.
Danish: Ved høje doser og efter længerevarende anvendelse, kan der forekomme nedsættelse af hjernefunktionen.
English: Talk to your doctor or pharmacist before taking Lysodren.
Danish: Kontakt lægen eller apoteketspersonalet, før De tager Lysodren.
English: The activity of liver enzymes (gamma-GT, aminotransferase, alkaline phosphatase) is commonly increased.
Danish: Aktiviteten af leverenzymer (gamma-GT, aminotransferase, alkalisk fosfatase) er almindeligvis øget.
English: Because of its lipophilic nature, mitotane is not likely to be dialysable.
Danish: På grund af dets lipofile natur, er mitotan sandsynligvis ikke dialysabelt.
English: Caution should be taken when co-prescribing active substances metabolised by this pathway such as, among others, sunitinib and midazolam.
Danish: Der bør udvises forsigtighed, når der samtidig ordineres aktive stoffer, som metaboliseres ad denne vej, f.eks. sunitinib og midazolam.
English: Mitotane plasma levels higher than 20 mg/l may be associated with severe undesirable effects and offer no further benefit in terms of efficacy.
Danish: Mitotanplasmaniveauer over 20 mg/l kan være forbundet med alvorlige bivirkninger og giver ikke yderligere fordele i effektivitet.
English: The usual starting dose for adults is 2 to 3 g (4 to 6 tablets) per day.
Danish: Den normale startdosis for en voksen er 2 til 3 g (4 til 6 tabletter) om dagen.
English: Mitotane is an adrenal cytotoxic active substance, although it can apparently also cause adrenal inhibition without cellular destruction.
Danish: Mitotan er en adrenal cytotoksisk aktiv substans, selvom det tilsyneladende også kan medføre adrenal hæmning uden cellulær destruktion.
English: Psychiatric disorders Confusion
Danish: Psykiske forstyrrelser Konfusion
English: The administration of mitotane alters the extra-adrenal metabolism of cortisol in humans, leading to a reduction in measurable 17-hydroxy corticosteroids, even though plasma levels of corticosteroids do not fall.
Danish: Administrationen af mitotan ændrer den ekstra-adrenale metabolisme af kortisol hos mennesket, ledende til en reduktion i målbare 17-hydroxy kortikosteroider, også selvom plasmaniveauer af kortikosteroider ikke falder.
English: It should be taken into account that dose adjustments do not produce immediate changes in plasma levels of mitotane (see section 4.4).
Danish: Man bør tage i betragtning, at dosisjustering ikke medfører øjeblikkelige ændringer i plasma-mitotanniveauer (se pkt.
English: Store in the original packaging.
Danish: Opbevares i den originale pakning.
English: Premenopausal women
Danish: Præmenopausale kvinder
English: If you forget to take Lysodren
Danish: Hvis De har glemt at tage Lysodren
English: Spironolactone: Mitotane must not be given in combination with spironolactone, since this active substance may block the action of mitotane (see section 4.3).
Danish: Spironolacton: Mitotan må ikke gives i kombination med spironolacton, da dette aktive stof kan blokere virkningen af mitotan (se pkt.
English: Paediatric patients: In children and adolescents, neuro-psychological retardation can be observed during mitotane treatment.
Danish: Pædiatriske patienter: Hos børn og unge kan der observeres neuro-psykologisk retardering under behandling med mitotan.
English: This dose of Lysodren was continued or decreased in function of side effects and plasma mitotane levels.
Danish: Denne dosis Lysodren blev fortsat eller nedsat som funktion af bivirkninger og plasma-mitotanniveauer.
English: Before the initiation of the treatment: Large metastatic masses should be surgically removed as far as possible before starting mitotane treatment, in order to minimise the risk of infarction and haemorrhage in the tumour due to a rapid cytotoxic effect of mitotane.
Danish: Inden behandlingens indledning: Store metastaser bør så vidt muligt fjernes kirurgisk, inden mitotanbehandlingen startes for at minimere risikoen for infarkt og blødning i tumoren grundet en hurtig cytotoksisk virkning af mitotan.
English: Mitotane plasma levels and the possible relationship with its efficacy were studied in the FIRM ACT trial, a randomized, prospective, controlled, open-label, multicenter, parallel-group study to compare the efficacy of etoposide, doxorubicin and cisplatin plus mitotane (EDP/M) to that of streptozotocin plus mitotane (Sz/M) as first-line treatment in 304 patients.
Danish: Mitotanplasmaniveauer og den mulige relation til dets effektivitet blev undersøgt i FIRM ACTforsøget et randomiseret, prospektivt, kontrolleret, open-label, multicenter parallelgruppe-forsøg, der sammenlignede effektiviteten af etoposid, doxorubicin og cisplatin plus mitotan (EDP/M) med streptozotocin plus mitotan (Sz/M) som førstevalgsbehandling hos 304 patienter.
English: It is recommended to increase frequency of mitotane plasma level monitoring (e.g. every two weeks) in patients at risk of overdose (e.g. in case of renal or hepatic impairment, obese patients or patients with a recent weight loss).
Danish: Det anbefales at øge frekvensen af monitorering af plasma-mitotanniveauet (f.eks. hver anden uge) hos patienter, der er i risiko for overdosering (f.eks. ved nyre- eller leverskade, hos overvægtige patienter eller patienter med nyligt vægttab).
English: After six months mitotane plasma levels were undetectable and the patient recovered clinically.
Danish: Efter seks måneder kunne der ikke påvises mitotan i plasma, og patienten kom sig klinisk.
English: The target plasma mitotane concentration (14 mg/l) was reached in all patients within 3 to 5 months and the total mitotane dose ranged between 283 and 387 g (median value: 363 g).
Danish: Målt plasma-mitotankoncentration (14 mg/l) blev nået hos alle patienter indenfor 3 til 5 måneder, og den totale mitotandosis strakte sig mellem 283 og 387 g (median værdi: 363 g).
English: 76-78, avenue du Midi
Danish: CENTRE SPECIALITES PHARMACEUTIQUES 76-78, avenue du Midi
English: Among the latter, three studies find such an increase only in patients in whom mitotane plasma is above 14 mg/l.
Danish: Blandt de sidste finder tre undersøgelser kun sådan en øgning hos patienter, hos hvem plasmamitotanniveauet er over 14 mg/l.
English: In the absence of information on the specific P450 isoenzymes involved, caution should be taken when co-prescribing active substances metabolised by this route such as, among others, anticonvulsants, rifabutin, rifampicin, griseofulvin and St. John's wort (Hypericum perforatum).
Danish: På grund af manglende information om de specifikke involverede P450 isoenzymer bør der udvises forsigtighed, når der samtidig ordineres aktive substanser, der metaboliseres i dette system, såsom bl.a. antikonvulsiva, rifabutin, rifampicin, griseofulvin og perikon (Hypericum perforatum).
English: - The active substance is mitotane.
Danish: - Aktivt stof: mitotan.
English: Mitotane plasma levels should therefore be monitored in order to adjust the Lysodren dose and to avoid reaching toxic levels.
Danish: Mitotanplasmaniveauer bør derfor monitoreres med henblik på at justere dosis af Lysodren samt undgå, at toksiske niveauer nås.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND ON THE IMMEDIATE PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN INDRE EMBALLAGE
English: Due to the lipophilic nature of mitotane, it is likely to be excreted in breast milk.
Danish: Grundet mitotans lipofile natur vil det sandsynligvis blive udskilt i mælk.
English: Lysodren is available in plastic bottles of 100 tablets.
Danish: Lysodren findes i plastflasker med 100 tabletter.
English: Use in children and adolescents The starting daily dose of Lysodren is 1.5 to 3.5 g/m2 body surface (this will be calculated by your doctor according to the weight and the size of the child).
Danish: Den daglige startdosis Lysodren er 1,5 til 3,5 g/m² legemsoverflade (dette vil blive beregnet af Deres læge ud fra barnets vægt og størrelse).
English: Exogenous steroids should be administered in such circumstances, since the depressed adrenal gland may not immediately start to secrete steroids.
Danish: Eksogene steroider bør gives under sådanne omstændigheder, da den svækkede binyre måske ikke umiddelbart begynder at udskille steroider.
English: Hormone binding protein: Mitotane has been shown to increase plasma levels of hormone binding proteins (e.g. sex hormone-binding globulin (SHBG) and corticosteroid-binding globulin (CBG).
Danish: Hormonbindende protein: Mitotan har vist sig at øge plasmaniveauer af hormonbindende protein (f.eks. kønshormonbindende globulin (SHBG) og kortikosteroidbindende globulin (CBG)).
English: Cytotoxic.
Danish: Cytotoksisk.
English: Premenopausal women: Ovarian macrocysts have been observed with higher incidence in this population.
Danish: Præmenopausale kvinder: Øget forekomst af makrocyster i ovarierne er set i denne gruppe.
English: No proven antidotes have been established for mitotane overdose.
Danish: Ingen bevislige modgifte er blevet fastslået for mitotan overdosering.
English: In addition, mitotane induces a state of adrenal insufficiency which leads to the disappearance of Cushing syndrome in patients with secreting adrenal carcinoma and necessitates substitution hormonotherapy.
Danish: Derudover inducerer mitotan en tilstand af binyrebarkinsufficiens, der leder til forsvinden af Cushings syndrom hos patienter med udskillende adrenalt carcinom og nødvendiggør substituerende hormonbehandling.
English: Cases of liver damage (hepatocellular, cholestatic and mixed) and autoimmune hepatitis were observed.
Danish: Der blev observeret tilfælde af leverskader (hepatocellulær, kolestatisk og blandet) og autoimmun hepatitis.
English: Fat-rich food: Data with various mitotane formulations suggest that administration with fat-rich food enhances absorption of mitotane.
Danish: Madvarer med højt fedtindhold: Data med forskellige formuleringer af mitotan antyder, at administration sammen med madvarer med højt fedtindhold fremmer absorptionen af mitotan.
English: Store in the original container.
Danish: Opbevares i den originale beholder.
English: Side effects may occur with certain frequencies, which are defined as follows: - very common: may affect more than 1 in 10 people - common: may affect up to 1 in 10 people - not known: frequency cannot be estimated from the available data
Danish: Bivirkninger kan forekomme med visse hyppigheder, der defineres som følger: - Meget almindelig: Kan påvirker flere end 1 ud af 10 personer.
English: You can divide the total daily dose in two or three intakes.
Danish: Den totale daglige dosis kan fordeles på to eller tre doser.
English: HRA Pharma Rare Diseases 200 avenue de Paris
Danish: HRA Pharma Rare Diseases 200 avenue de Paris 92320 CHATILLON Frankrig
English: Caution and close monitoring of mitotane plasma levels are highly recommended when treating overweight patients.
Danish: Forsigtighed og nøje monitorering af plasma-mitotanniveauet anbefales kraftigt ved behandling af overvægtige patienter.
English: The prolonged elimination of mitotane from the body after discontinuation of Lysodren should be considered.
Danish: Den langvarige elimination af mitotan efter seponering af Lysodren bør tages i betragtning.
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Danish: FARMAKOLOGISKE EGENSKABER 5.1 Farmakadynamiske egenskaber
English: In such cases, thyroid function should be investigated in order to identify a possible thyroid impairment linked to mitotane treatment.
Danish: I sådanne tilfælde bør thyroideafunktionen undersøges for at identificere en mulig thyroideaforringelse forbundet med mitotanbehandling.
English: This should be taken into account when interpreting the results of hormonal assays and may result in gynaecomastia.
Danish: Dette bør tages i betragtning, når resultaterne af hormonale bestemmelser fortolkes, og det kan medføre gynækomasti.
English: Monitoring of plasma levels: Mitotane plasma levels should be monitored in order to adjust the mitotane dose, particularly if high starting doses are considered necessary.
Danish: Monitorering af plasmaniveauer: Mitotanplasmaniveauer bør monitoreres med henblik på justering af dosis af mitotan, navnlig hvis høje startdoser anses for nødvendige.
English: Neuro-psychological retardation may be observed during mitotane treatment.
Danish: Neuro-psykologisk retardering kan observeres under behandling med mitotan.
English: Treatment can be resumed when mitotane plasma levels will be ranged between 14 - 20 mg/l.
Danish: Behandling kan genoptages, når plasma-mitotanniveauerne ligger mellem 14-20 mg/l.
English: Bleeding time: Prolonged bleeding time has been reported in patients treated with mitotane and this should be taken into account when surgery is considered (see section 4.8).
Danish: Blødningstid: Der er rapporteret forlænget blødningstid hos patienter behandlet med mitotan, og dette bør tages i betragtning, når der overvejes operation (se pkt.
English: This medicine is used for the treatment of symptoms of advanced non operable, metastatic or recurrent malignant tumours of the adrenal glands.
Danish: Dette lægemiddel anvendes til behandling af symptomer på fremskredne ikke-operable, metastatiske eller tilbagevendende maligne tumorer i binyrerne.
English: Leucopenia (including neutropenia), anemia and thrombocytopenia have been reported frequently during mitotane treatment (see section 4.8).
Danish: Leukopeni (herunder neutropeni), anæmi og trombocytopeni er ofte rapporteret under behandling med mitotan (se pkt.
English: SN: NN:
Danish: NN:
English: Particularly, mitotane has been shown to have an inductive effect on cytochrome 3A4.
Danish: Især har mitotan vist sig at have en induktiv effekt på CYP3A4.
English: Hepatic or renal impairment: There are insufficient data to support the use of mitotane in patients with severe hepatic or renal impairment.
Danish: Nedsat lever- eller nyrefunktion: Der er utilstrækkelige data til at understøtte anvendelsen af mitotan hos patienter med kraftigt nedsat lever- eller nyrefunktion.
English: You must not breast-feed while taking Lysodren.
Danish: De må ikke amme, mens De tager Lysodren.
English: Always keep with you the Lysodren Patient Card included at the end of this leaflet.
Danish: Hav altid det patientkort, der findes til sidst i denne indlægsseddel, på Dem.
English: Women should be urged to seek medical advice if they experience gynaecological symptoms such as bleeding and/or pelvic pain.
Danish: Kvinden skal informeres om at søge læge i tilfælde af gynækologiske symptomer som blødnig og/eller underlivssmerter.
English: Dose adjustments may be necessary to achieve the desired therapeutic levels in the window between 14 - 20 mg/l and avoid specific adverse reactions (see section 4.2).
Danish: Dosisjusteringer kan være nødvendige for at nå de ønskede terapeutiske niveauer i vinduet mellem 14-20 mg/l og undgå specifikke bivirkninger (se pkt.
English: Central nervous system disorders: Long-term continuous administration of high doses of mitotane may lead to reversible brain damage and impairment of function.
Danish: Forstyrrelser i centralnervesystemet: Længerevarende, løbende indgivelse af høje doser af mitotan kan lede til reversibel hjerneskade og funktionsnedsættelse.
English: Dose adjustment is aimed to reach a therapeutic window (mitotane plasma levels 14 - 20 mg/l) which ensures optimal use of Lysodren with acceptable safety.
Danish: Dosisjustering foretages for at nå et terapeutisk vindue (plasma-mitotanniveau 14-20 mg/l), hvilket sikrer optimal anvendelse af Lysodren med acceptabel sikkerhed.
English: Your doctor should do blood tests to check your liver function before and during treatment with Lysodren, and as clinically indicated.
Danish: Lægen skal tage nogle blodprøver for at kontrollere Deres leverfunktion før og under behandling med Lysodren og desuden, hvis der er klinisk behov for det.
English: The dose of your anticoagulant may need adjustment.
Danish: Dosis af Deres blodfortyndende midler skal måske justeres.
English: Liver damage (hepatocellular/cholestatic /mixed)
Danish: Leverskade (hepatocellulær/kolestatisk /blandet)
English: Paediatric patients The experience in children is limited.
Danish: Pædiatrisk population Erfaring med behandling af børn er begrænset.
English: Since mitotane is mainly metabolised through the liver, mitotane plasma levels are expected to increase if liver function is impaired.
Danish: Da mitotan hovedsagelig bliver metaboliseret gennem leveren, forventes plasma-mitotanniveauer at øges, hvis leverfunktionen er nedsat.
English: Square opaque white HDPE bottle having a thread on the mouth containing 100 tablets.
Danish: Firkantet, ugennemsigtig, hvid HDPE-flaske med en gevind ved åbningen indeholdende 100 tabletter.
English: - -if you have liver problems: Tell your doctor if you develop any of the following signs and symptoms of liver problems during Lysodren treatment: itching, yellow eyes or skin, dark urine, and pain or discomfort in the right upper stomach area.
Danish: - Hvis De har leverproblemer: Fortæl det til lægen, hvis De udvikler et af følgende tegn og symptomer på leverproblemer under behandling med Lysodren: kløe, gulfarvning af øjne eller hud, mørk urin og smerter eller ubehag øverst til højre i maveregionen.
English: Warfarin and coumarin-like anticoagulants: Mitotane has been reported to accelerate the metabolism of warfarin through hepatic microsomal enzyme induction, leading to an increase in dose requirements for warfarin.
Danish: Warfarin og coumarinlignende antikoagulantia: Mitotan er blevet rapporteret at fremme metaboliseringen af warfarin ved hepatisk mikrosomal enzyminduktion, hvilket kan medføre behov for øget dosis af warfarin.
English: Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske lægemidler.
English: Maculopathy Retinal toxicity Diplopia
Danish: Makulopati Retinal toksicitet Diplopi
English: Since mitotane increases plasma levels of steroid binding proteins, free cortisol and corticotropin (ACTH) determinations are necessary for optimal dosing of steroid substitution (see section 4.8).
Danish: Eftersom mitotan øger plasmaniveauer af steroidbindende proteiner, er det nødvendigt at bestemme fri kortisol og corticotropin (ACTH) for optimal dosering af steroidsubstitution (se pkt.
English: Epigastric discomfort
Danish: Epigastrisk ubehag
English: Nervous system undesirable effects appear reversible after cessation of mitotane treatment and decrease in plasma levels (see section 4.4).
Danish: Bivirkninger på nervesystemet forekommer reversible efter ophør med mitotanbehandling og fald i plasmaniveauer (se pkt.
English: The total daily dose may be divided in two or three doses according to patient's convenience.
Danish: Den totale daglige dosis kan deles i 2 eller 3 doser, efter hvad der er praktisk for patienten.
English: Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma (ACC).
Danish: Symptomatisk behandling af fremskreden (inoperabelt, metastaserende eller genkommet) adrenokortikalt karcinom.