FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of mitotane in patients with severe renal impairment is not recommended and, in cases of mild to moderate renal impairment, caution should be exercised.
Danish: Brug af mitotan hos patienter med svær nedsat nyrefunktion anbefales ikke, og i tilfælde af let til moderat nedsat nyrefunktion bør der udvises forsigtighed.
English: Each tablet contains 500 mg of mitotane.
Danish: Hver tablet indeholder 500 mg mitotan.
English: Mitotane plasma levels should be monitored as for adults, with particular attention when plasma levels reach 10 mg/l as a quick increase in plasma levels may be observed.
Danish: Mitotanplasmaniveauer bør monitoreres som for voksne med særlig opmærksomhed, når plasmaniveauerne når 10 mg/l, da der kan ses en hurtig stigning i plasmaniveauerne.
English: Therefore, patients should be closely monitored for a change in anticoagulant dose requirements when mitotane is administered to patients on coumarin-like anticoagulants.
Danish: Derfor skal patienterne monitoreres tæt med henblik på eventuel ændring af antikoagulansdosis, når mitotan gives til patienter i behandling med coumarin-lignende antikoagulantia.
English: Contents of the pack and other information What Lysodren contains
Danish: Pakningsstørrelser og yderligere oplysninger Lysodren indeholder:
English: Hepatotoxicity has been observed in patients treated with mitotane.
Danish: Der er observeret hepatotoksicitet hos patienter i behandling med mitotan.
English: You should swallow the tablets with a glass of water during meals containing fat-rich food.
Danish: De skal sluge tabletter med et glas vand i forbindelse med måltider med madvarer med et højt fedtindhold.
English: Ovarian macrocysts
Danish: Makrocyster i ovarierne
English: Therefore, the plasma concentrations of the substances metabolised via cytochrome 3A4 may be modified.
Danish: Derfor kan plasmakoncentrationerne af stoffer, der metaboliseres via CYP3A4, ændres.
English: - The other ingredients are maize starch, microcrystalline cellulose (E 460), macrogol 3350 and silica colloidal anhydrous.
Danish: - Øvrige indholdsstoffer: majsstivelse, mikrokrystallinsk cellulose (E460), macrogol 3350 og silica, kolloid, vandfri.
English: Lysodren (Braille applies only to outer carton)
Danish: Lysodren (kun på den ydre emballage)
English: Non-malignant ovarian macrocysts (with symptoms such as pelvic pain, bleeding) have been described.
Danish: Ikke-maligne makrocyster i ovarierne er beskrevet (med symptomer som underlivssmerter og blødning).
English: This leaflet is available in all European languages on the EMA website.
Danish: Denne indlægsseddel findes på alle EU-/EØS-sprog på Det Europæiske Lægemiddelagenturs hjemmeside.
English: Paediatric patients
Danish: Hos pœdiatriske patienter
English: Patients should carry with them the Lysodren Patient Card provided with the package leaflet indicating that they are prone to adrenal insufficiency and that, in case of emergency care, adequate precautionary measures should be taken.
Danish: Patienterne bør have Lysodren patientkortet, der medfølger indlægssedlen, på sig indikerende, at de er tilbøjelige til binyrebarkinsufficiens, og at der i tilfælde af en nødsituation tages tilstrækkelige forholdsregler.
English: Substances metabolised through cytochrome P450 and particularly cytochrome 3A4: Mitotane is a hepatic enzyme inducer and it should be used with caution in case of concomitant use of medicinal products influenced by hepatic metabolism (see section 4.5).
Danish: Stoffer, der metaboliseres af CYP450 og især CYP3A4: Mitotan inducerer leverenzymer og bør anvendes med forsigtighed ved samtidig anvendelse af lægemidler, der metaboliseres i leveren (se pkt.
English: Improvement after mitotane discontinuation has been observed.
Danish: Bedring efter seponering af mitotan er iagttaget.
English: Monitoring of mitotane plasma levels is specially recommended in these patients (see section 4.4).
Danish: Monitorering af plasma-mitotanniveauer anbefales især hos disse patienter (se pkt.
English: OUTER CARTON BOTTLE LABEL
Danish: YDRE ÆSKE FLASKEETIKET
English: Mitotane tissue accumulation: Fat tissue can act as a reservoir for mitotane, resulting in a prolonged half-life and potential accumulation of mitotane.
Danish: Mitotan vævsakkumulation: Fedtvæv kan fungere som reservoir for mitotan, hvilket medfører en øget halveringstid og mulig akkumulering af mitotan.
English: Isolated cases of complicated cysts have been reported (adnexal torsion and haemorrhagic cyst rupture).
Danish: Enkeltstående tilfælde af komplicerede cyster er indberettet (torkveret adnex og hæmoragisk cysteruptur).
English: White, biconvex, round, scored tablets.
Danish: Hvide, bikonvekse, runde tabletter med delekærv.
English: Mitotane plasma levels should be assessed after each dose adjustment and at frequent intervals (e.g. every two weeks), until the optimal maintenance dose is reached.
Danish: Mitotanplasmaniveauer skal vurderes efter hver dosisændring og med frekvente intervaller (f.eks. hver anden uge), indtil den optimale vedligeholdelsesdosis er nået.
English: Package leaflet: Information for the user Lysodren 500 mg tablets mitotane
Danish: Indlægsseddel: Information til brugeren Lysodren 500 mg tabletter mitotan
English: Anaemia Thrombocytopenia
Danish: Anæmi Trombocytopeni
English: Patients should be advised not to use any tablets showing signs of deterioration, and caregivers to wear disposable gloves when handling the tablets.
Danish: Patienter bør tilrådes ikke at tage tabletter med synlige tegn på nedbrydning, og sundhedspersonalet skal bruge engangshandsker, når de håndterer tabletterne.
English: Metabolism studies in man have identified the corresponding acid, 1,1-(o,p'-dichlorodiphenyl) acetic acid (o,p'-DDA), as the major circulating metabolite, together with smaller quantities of the 1,1-(o,p'
Danish: Metabolismeundersøgelser hos mennesket har identificeret den tilhørende syre, 1,1-(o,p'dichlordiphenyl) eddikesyre ( o,p'-DDA), som den væsentlige cirkulerende metabolit, sammen med mindre mængder af 1,1-(o,p'-dichlordiphenyl)-2,2 dichlorethen (o,p'-DDE) analogen af mitotan.
English: Serious undesirable effects appear linked to the cumulative exposure to mitotane and are most likely to occur when mitotane plasma levels are at 20 mg/l or above.
Danish: Alvorlige bivirkninger synes forbundet med den kumulative eksponering for mitotan og vil sandsynligvis forekomme, når plasma-mitotanniveauet er på 20 mg/l eller derover.
English: Concomitant use with spironolactone (see section 4.5)
Danish: Samtidig anvendelse af spironolacton (se pkt.
English: Liver enzymes levels normalize when the mitotane dose is decreased.
Danish: Leverenzymniveauer normaliseres, når mitotandosis bliver sat ned.
English: Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: In patients with mild or moderate hepatic or renal impairment, caution should be exercised and monitoring of mitotane plasma levels is particularly recommended (see section 4.2).
Danish: Hos patienter med mild eller moderat nedsat lever- eller nyrefunktion bør der udvises forsigtighed, og monitorering af plasmamitotanniveauer anbefales specielt (se pkt.
English: There are some data suggesting that mitotane plasma above 14 mg/l may result in enhanced efficacy (see section 5.1).
Danish: Der er visse data, der tyder på, at plasma-mitotan over 14 mg/l kan give øget virkning, se pkt.
English: Treatment in adults should be started with 2 - 3 g mitotane per day and increased progressively (e.g. at two-week intervals) until mitotane plasma levels reach the therapeutic window 14 - 20 mg/l.
Danish: Behandling af voksne skal indledes med 2-3 g mitotan dagligt og progressivt øges (f.eks. hver anden uge), indtil plasma-mitotanniveauet når det terapeutiske vindue på 14-20 mg/l.
English: Regular monitoring (e.g. every two months) of mitotane plasma levels is also necessary after interruption of treatment.
Danish: Regelmæssig monitorering (f.eks. hver anden måned) af plasma-mitotanniveauer er også nødvendig efter seponering af behandlingen.
English: Caution should be exercised and frequent monitoring of mitotane plasma levels is especially recommended in these patients.
Danish: Der bør udvises forsigtighed, og regelmæssig monitorering af plasma-mitotanniveauer anbefales særligt til disse patienter.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.emea.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Tell your doctor immediately, who may decide to temporarily stop treatment.
Danish: Fortæl det straks til Deres læge, som kan beslutte at stoppe Lysodren for en tid.
English: What you need to know before you take Lysodren Do not take Lysodren
Danish: Det skal De vide, før De begynder at tage Lysodren Tag ikke Lysodren
English: Warfarin and coumarin-like anticoagulants: When administering mitotane to patients on coumarinlike anticoagulants, patients should be closely monitored for a change in anticoagulant dose requirements (see section 4.5).
Danish: Warfarin og coumarin-lignende antikoagulantia: Ved administration af mitotan til patienter, som får coumarin-lignende antikoagulantiga, skal patienterne monitoreres tæt med henblik på eventuel ændring af antikoagulans-dosis (se pkt.
English: Salivary hypersecretion Dysgeusia
Danish: Hypersalivation Dysgeusi
English: Mitotane overdose may lead to central nervous system impairment especially if mitotane plasma levels are above 20 mg/l.
Danish: Mitotan-overdosering kan lede til svækkelse af centralnervesystemet, især hvis plasmamitotanniveauet er over 20 mg/l.
English: In addition, because of tissue accumulation, mitotane plasma levels should be monitored regularly (e.g. monthly) once the maintenance dose has been reached.
Danish: På grund af vævsakkumulation bør plasma-mitotanniveauer desuden monitoreres regelmæssigt (f.eks. en gang om måneden), når vedligeholdelsesdosen er nået.
English: Lysodren may harm the foetus.
Danish: Lysodren kan skade fostret.
English: NAME AND ADDRESS OF THE MARKETING AUTORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: Balance disorders
Danish: Balanceforstyrrelser
English: Reproductive toxicity studies have not been performed with mitotane.
Danish: Reproduktive toksicitetsundersøgelser er ikke blevet udført med mitotan.
English: Dosing should be individually adjusted based on mitotane plasma levels monitoring and clinical tolerance until mitotane plasma levels reach the therapeutic window 14 - 20 mg/l.
Danish: Dosering bør justeres individuelt på grundlag af monitorering af plasma-mitotanniveauer og klinisk tolerance, indtil plasma-mitotanniveauerne når det terapeutiske vindue på 14-20 mg/l.
English: Women of childbearing potential must use an effective contraception during treatment and after discontinuation of treatment as long as mitotane plasma levels are detectable.
Danish: Kvinder i den fertile alder skal anvende sikker kontraception under behandling og efter seponering af behandlingen, så længe mitotan kan detekteres i plasma.
English: You should tell your doctor if any of the following applies to you: - if you have an injury (shock, severe trauma), an infection or if you have any illness while you are taking Lysodren.
Danish: De skal fortælle lægen, hvis noget af følgende gælder for Dem: - Hvis De kommer til skade (shock, alvorligt traume), får en infektion, eller hvis De bliver syg, mens De tager Lysodren.
English: Blood uric acid decreased Blood androstenedione decreased (in females) Blood testosterone decreased (in females) Sex hormone binding globulin increased Blood free testosterone decreased (in males)
Danish: Nedsat blodurinsyre Nedsat androstendion i blodet (hos kvinder) Nedsat testosteron i blodet (hos kvinder) Forhøjet kønshormonbindende globulin
English: In children and adolescents, thyroid problems, neuro-psychological, growth retardation and one case of encephalopathy have been observed.
Danish: Hos børn og unge er thyroideaproblemer (problemer med skjoldbruskkirtlen), neuropsykologisk retardering, væksthæmning og et tilfælde af encefalopati (forstyrrelse af hjernens funktion) observeret.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG FOR MARKEDSFØRINGSTILLADELSEN
English: Hypercholesterolemia Hypertriglyceridaemia
Danish: Hyperkolesterolæmi Hypertriglyceridæmi
English: Tablets should be taken with a glass of water during meals containing fat-rich food (see section 4.5).
Danish: Tabletter bør tages med et glas vand i forbindelse med måltider med madvarer med et højt fedtindhold (se pkt.
English: Other medicines and Lysodren
Danish: Brug af anden medicin sammen med Lysodren
English: Data on a limited number of exposed pregnancies indicate abnormalities on the adrenals of the foetus after exposure to mitotane.
Danish: Data for anvendelse af mitotan hos et begrænset antal gravide indikerer abnormiteter i binyrerne hos fostret.
English: Lysodren tablets are white, biconvex, round and scored.
Danish: Lysodrentabletter er hvide, bikonvekse, runde tabletter med delekærv.
English: Animal reproduction studies have not been conducted with mitotane.
Danish: Reproduktionsundersøgelser på dyr er ikke blevet gennemført med mitotan.
English: Therefore, monitoring of mitotane plasma levels (e.g. every two months) is also necessary after interruption of treatment, as prolonged release of mitotane can occur.
Danish: Monitorering af plasma-mitotanniveauer (f.eks. hver anden måned) er derfor også nødvendig efter seponering af behandling, da der kan forekomme længerevarende frigørelse af mitotan.
English: Ataxia Paresthesia Vertigo Sleepiness
Danish: Ataksi Paræstesi Vertigo
English: Lysodren 500 mg tablets
Danish: Lysodren 500 mg tabletter
English: Haemorrhagic cystitis Haematuria Proteinuria
Danish: Hæmoragisk cystitis Hæmaturi
English: System Organ Class
Danish: Organklasse
English: Any unused product or waste material should be disposed of in accordance with local requirements
Danish: Ikke anvendte lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Hypertension Orthostatic hypotension Flushing
Danish: Hypertension Ortostatisk hypotension Ansigtsrødme
English: In patients with mild to moderate hepatic impairment, caution should be exercised and monitoring of liver function should be performed.
Danish: Hos patienter med let til moderat nedsat leverfunktion bør der udvises forsigtighed, og leverfunktionen bør monitoreres.
English: Dyspepsia
Danish: Dyspepsi
English: Hyperpyrexia Generalised aching
Danish: Hyperpyreksi Generaliseret ømhed
English: Leucopoenia Bleeding time prolonged
Danish: Blod og lymfesystem Leukopeni Blødningstid forlænget
English: Caregivers should wear disposable gloves when handling the tablets.
Danish: Plejere bør bruge engangshandsker, når de håndterer tabletterne.
English: - if you are allergic to mitotane or any of the other ingredients of this medicine (listed in section - if you are breast-feeding.
Danish: - hvis De er allergisk over for mitotan eller et af de øvrige indholdsstoffer i Lysodren (angivet i punkt 6).
English: Women of childbearing potential: Women of childbearing potential must use effective contraception during treatment with mitotane (see section 4.6).
Danish: Kvinder i den fertile alder: Kvinder i den fertile alder skal anvende sikker kontraception under behandling med mitotan (se pkt.
English: The use of mitotane in patients with severe hepatic impairment is not recommended.
Danish: Brug af mitotan til patienter med stærkt nedsat leverfunktion anbefales ikke.
English: Therefore, the plasma concentrations of the substances metabolised via cytochrome P450 may be modified.
Danish: Plasmakoncentrationerne af stoffer metaboliseret via CYP kan derfor ændres.
English: Medicinal products active on central nervous system: Mitotane can cause central nervous system undesirable effects at high concentrations (see section 4.8).
Danish: Lægemidler med indvirkning på centralnervesystemet: Mitotan kan forårsage bivirkninger i centralnervesystemet ved høje koncentrationer (se pkt.
English: - if you are being treated with medicines containing spironolactone (see "Other medicines and
Danish: - hvis De bliver behandlet med lægemidler med spironolacton (se "Brug af anden medicin sammen med Lysodren").
English: Elevated liver enzymes Plasma cholesterol increased
Danish: Forhøjede leverenzymer Forhøjet plasmakolesterol Forhøjede plasmatriglycerider
English: Substances metabolised through cytochrome P450: Mitotane has been shown to have an inductive effect on cytochrome P450 enzymes.
Danish: Stoffer, der metaboliseres via CYP: Mitotan har vist sig at have en induktiv virkning på CYP-enzymer.
English: Hepatic impairment
Danish: Svimmelhed Hovedpine
English: Mental impairment Polyneuropathy Movement disorder Dizziness Headache
Danish: Mental svækkelse Polyneuropati Bevægelsesforstyrrelse
English: Behavioural and neurological assessments should be made at regular intervals, especially when mitotane plasma levels exceed
Danish: Der bør foretages adfærdsmæssige og neurologiske vurderinger med regelmæssige intervaller, især når plasma-mitotanniveauer overskrider 20 mg/l (se pkt.
English: Lysodren 500 mg tablets mitotane
Danish: Lysodren 500 mg tabletter mitotan
English: OTHER SPECIAL WARNING (S), IF NECESSARY
Danish: EVENTUELT ANDRE SÆRLIGE ADVARSLER
English: How to take Lysodren
Danish: Sådan skal De tage Lysodren
English: There is no experience on the use of mitotane in older patients, so data are insufficient to give a dose recommendation in this group.
Danish: Der er ingen erfaring med brugen af mitotan til ældre patienter, så data er utilstrækkelige til at give en dosisanbefaling for denne gruppe.
English: If you may become pregnant, you should use an effective contraception during treatment with Lysodren and even after stopping it, ask your doctor for advice.
Danish: Hvis De har mulighed for at blive gravid, bør De anvende sikker kontraception under behandlingen med Lysodren, og når behandlingen er slut.
English: Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: mg/l could suggest that patients with mitotane plasma levels ≥ 14 mg/l could have an improvement in disease control rate (62.9% versus 33.5%; p< 0.
Danish: Analysen af patienter, som opnåede mitotanniveauer ≥ 14 mg/l mindst en gang i løbet af 6 måneder, i forhold til patienter, hvis mitotanniveauer var < 14 mg/l, kunne tyde på, at patienter med plasma-mitotanniveauer ≥ 14 mg/l kunne opnå en forbedring i sygdommens kontrolrate (62,9 % i forhold til 33,5 %; p< 0,0001).
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: - antiepileptics - rifabutin or rifampicin, used to treat tuberculosis - griseofulvin, used in the treatment of fungal infections - herbal preparations containing St. John's wort (Hypericum perforatum) - Sunitinib: to treat cancer
Danish: - Griseofulvin, der bruges til behandling af svampeinfektioner - Naturmedicin, der indeholder perikon (Hypericum perforatum).
English: There is no experience in the use of mitotane in patients with renal impairment, so data are insufficient to give a dose recommendation in this group.
Danish: Der er ingen erfaring med brugen af mitotan til patienter med nedsat nyrefunktion, så data er utilstrækkelige til at give en dosisanbefaling for denne gruppe.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of the medicine.
Danish: Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Tell your doctor immediately if you experience any of the following side effects: - Adrenal insufficiency: fatigue, abdominal pain, nausea, vomiting, diarrhoea, confusion - Anaemia: cutaneous pallor, muscular fatigability, feeling breathless, vertigo especially when standing up - Liver damage: yellowing of the skin and eyes, itching, nausea, diarrhoea, fatigue, dark coloured urine - Neurological disorders: movement and coordination disorders, abnormal sensations like pins and needles, memory loss, concentration difficulty, difficulty to talk, vertigo
Danish: - Anæmi: Bleghed, muskelsvaghed, stakåndethed, svimmelhed, især når De rejser Dem. - Leverskade: Gulfarvning af hud og øjne, kløe, kvalme, diarré, træthed, mørk urin - Neurologiske forstyrrelser: Bevægelses- og koordinationsforstyrrelser, unormale fornemmelser såsom sovende fornemmelse, hukommelsestab, koncentrationsbesvær, talebesvær, svimmelhed.
English: PC:
Danish: SN:
English: For induction with cytochrome P450, see section 4.5.
Danish: Vedrørende induktion med CYP, se pkt.
English: The name of my Doctor is: Phone: ……………………………….
Danish: Min læges navn er:
English: You must not breast-feed while taking Lysodren and even after stopping it.
Danish: De må ikke amme, mens De tager Lysodren og heller ikke efter, De er holdt op. Spørg Deres læge til råds.
English: Breast-feeding is contraindicated while taking mitotane (see section 4.3) and after treatment discontinuation as long as mitotane plasma levels are detectable.
Danish: 4.3) og efter seponering af behandlingen, så længe mitotan kan detekteres i plasma.
English: - dizziness, headache
Danish: - Svimmelhed, hovedpine.
English: Lens opacity Visual impairment Vision blurred
Danish: Uklar linse Nedsat syn Sløret syn
English: Red blood cell, white blood cell and platelet counts should be monitored during mitotane treatment.
Danish: Erytrocytter, leukocytter og trombocytter skal monitoreres under behandlingen.
English: Endocrine disorders Adrenal insufficiency
Danish: Myasteni Det endokrine system Binyrebarkinsufficiens
English: MARKETING AUTORISATION NUMBER
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
English: LYSODREN PATIENT CARD I am on Lysodren (mitotane) treatment I am prone to acute adrenal insufficiency In case I need emergency care, adequate precautionary measures should be taken
Danish: LYSODREN-PATIENTKORT Jeg er i behandling med Lysodren (mitotan)
English: One case of encephalopathy has been observed in a paediatric patient five months after initiation of the treatment; this case was considered to be related to an increased mitotane plasma level of 34.5 mg/l.
Danish: Der er observeret et tilfælde af encefalopati hos en pædiatrisk patient fem måneder efter initiering af behandlingen.
English: Do not use after the expiry date which is stated on the carton and the bottle after EXP. Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic medicines.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Lactation (see section 4.6)
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.