FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical studies with a dosage of 12 mg/m2 daily for 5 days, patients who achieved a complete remission did so as a result of the first induction course.
Danish: Patienter, der opnåede fuldstændig remission i kliniske studier ved en dosis på 12 mg/m2 dagligt i 5 dage, opnåede den som resultat af det første induktionsforløb.
English: Mitoxantrone was found to be mutagenic in bacterial and mammalian test systems, as well as in vivo in rats.
Danish: Mitoxantron blev påvist at være mutagent i bakterie- og pattedyrstestsystemer samt in vivo hos rotter.
English: Amenorrhoea*
Danish: Amenore*
English: Treatment of blast crisis in (chronic) myeloid leukaemia Used alone for recurrence
Danish: Behandling af blastkrisen i (kronisk) myeloid leukæmi Hvis det bruges alene ved tilbagefald
English: When pregnant rabbits were treated during organogenesis, an increased incidence of premature delivery was observed at doses > 0.01 times the recommended human dose on an mg/m2 basis.
Danish: Når drægtige kaniner blev behandlet i organogeneseperioden, blev der observeret en øget forekomst af præmatur fødsel ved doser > 0,01 gange den anbefalede humane dosis på mg/m2-basis.
English: Paediatric population Safety and efficacy in paediatric patients have not been established.
Danish: Pædiatrisk population Sikkerhed og virkning hos pædiatriske patienter er ikke klarlagt.
English: Tell your doctor or pharmacist or nurse immediately if you get any of the following signs or symptoms during treatment with Novantrone: - fever, infections, unexplained bleeding or bruising, weakness and easy fatigability; - breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the ankles or legs , heart fluttering (irregular heart beat).
Danish: Fortæl det straks til lægen, apotekspersonalet eller sundhedspersonalet, hvis du får et eller flere af følgende tegn eller symptomer under behandlingen med Novantrone: - Feber, infektioner, uforklarlig blødning eller blå mærker, svækkelse og let udmattelse; - Åndenød (herunder åndenød om natten), hoste, væskeophobning (hævelse) i ankler eller ben,
English: For patients with hepatic impairment dose adjustment may be necessary as mitoxantrone clearance is reduced by hepatic impairment.
Danish: For patienter med nedsat leverfunktion kan dosisjustering blive nødvendig, fordi clearance af mitoxantron reduceres ved nedsat leverfunktion.
English: Immune system disorders Uncommon
Danish: Immunsystem Ikke almindelig
English: Metastatic breast cancer, non-Hodgkin's lymphoma
Danish: Metastatisk brystcancer, non-Hodgkin-lymfom
English: Oncology
Danish: Onkologisk indikation
English: What you need to know before you use Novantrone
Danish: Det skal du vide, før du begynder at bruge Novantrone
English: Evaluation of the left-ventricular ejection fraction (LVEF) by echocardiogram or MUGA is recommended prior to administration of the initial dose of mitoxantrone and prior to each dose in multiple sclerosis patients and yearly for up to 5 years after the end of therapy.
Danish: Vurdering af venstre ventrikels uddrivningsfraktion (LVEF) ved hjælp af ekkokardiogram eller MUGA anbefales før behandlingsstart af mitoxantron og før hver dosis til patienter med dissemineret sklerose og årligt i op til 5 år efter behandlingafslutning.
English: You should stop breast-feeding before taking Novantrone.
Danish: Du skal stoppe med at amme, før du bruger Novantrone.
English: Treatment of pregnant rats during the organogenesis period of gestation was associated with foetal growth retardation at doses > 0.01 times the recommended human dose on an mg/m2 basis.
Danish: Behandling af drægtige rotter i organogeneseperioden blev forbundet med forsinket fostervækst ved doser > 0,01 gange den anbefalede humane dosis på mg/m2-basis.
English: Hepatobiliary disorders Common
Danish: Hepatobiliærsystem Almindelig
English: Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causes crosslinks and strand breaks.
Danish: Mitoxantron er et DNA-reaktivt stof, der indføjes i deoxyribonukleinsyre (DNA) ved hydrogenbinding og forårsager tværbindinger og brud på strengen.
English: Acute myeloid leukemia (AML) and Myelodysplastic syndrome A group of anticancer medicines (topoisomerase II inhibitors), including Novantrone, may cause the following diseases when used alone but especially in combination with other chemotherapy and/or radiotherapy:
Danish: Akut myeloid leukæmi og myelodysplastisk syndrom En gruppe kræftmedicin (topoisomerase II-hæmmere), herunder Novantrone, kan give følgende sygdomme, når de bruges alene, men især, når de bruges i kombination med anden kemoterapi og/eller strålebehandling:
English: Myelosuppression is a dose-limiting undesirable effect of mitoxantrone.
Danish: Myelosuppression er en dosisbegrænsende bivirkning ved mitoxantron.
English: Uncommon (may affect up to 1 in 100 people) - Reduced activity of the bone marrow.
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100 personer) - Nedsat funktion af knoglemarven.
English: Thrombocytopenia Granulocytopenia
Danish: Trombocytopeni Granulocytopeni
English: Although patients with severe renal failure have not been studied, mitoxantrone is extensively tissue bound and it is unlikely that the therapeutic effect or toxicity would be mitigated by peritoneal or haemodialysis.
Danish: Mitoxantron er i udstrakt grad vævsbundet, og selv om patienter med svært nyresvigt ikke er blevet undersøgt, er det usandsynligt, at den terapeutiske virkning eller toksicitet kan nedsættes ved peritonealdialyse eller hæmodialyse.
English: Topoisomerase II inhibitors, including mitoxantrone, when used concomitantly with other antineoplastic agents and/or radiotherapy, have been associated with the development of Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS) (see section 4.8).
Danish: Topoisomerase II-inhibitorer, herunder mitoxantron, er, når de anvendes samtidigt med andre antineoplastiske præparater og/eller strålebehandling, blevet forbundet med udvikling af akut myeloid leukæmi (AML) eller myelodysplastisk syndrom (MDS) (se pkt.
English: Mitoxantrone is indicated in combination with corticosteroids for palliation (e.g. pain relief) related to advanced castrate resistant prostate cancer.
Danish: Mitoxantron er i kombination med kortikosteroider indiceret til palliativ behandling (f.eks. smertelindring) i forbindelse med fremskreden, kastratresistent prostatacancer.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including sulphites that may be produced during the manufacturing of mitoxantrone.
Danish: 6.1, herunder sulfitter, der kan blive dannet under fremstillingen af mitoxantron.
English: For this reason, the use of mitoxantrone to treat MS is contraindicated for pregnant women (see section 4.3).
Danish: Derfor er anvendelse af mitoxantron til behandling af MS kontraindiceret hos gravide kvinder (se pkt.
English: Elevated aspartate aminotransferase levels
Danish: Forhøjet aspartataminotransferase
English: If mitoxantrone is administered repeatedly dosing adjustments should be guided by extent and duration of bone marrow suppression.
Danish: Hvis mitoxantron indgives flere gange, bør dosisjustering styres af graden af knoglemarvssuppression og dens varighed.
English: Severe local tissue damage may occur if there is extravasation during administration.
Danish: Svær lokal vævsskade kan forekomme, hvis der forekommer ekstravasation under indgivelsen.
English: How to use Novantrone
Danish: Sådan skal du bruge Novantrone
English: Hepatotoxicity Elevated aspartate aminotransferase levels
Danish: Hepatotoksicitet Forhøjet aspartataminotransferase
English: Men must use an effective method of contraception during the treatment and for at least 6 months after discontinuing the treatment.
Danish: Mænd skal bruge en effektiv præventionsmetode under behandlingen og i mindst 6 måneder efter, behandlingen er afsluttet.
English: Cardiomyopathy
Danish: Kardiotoksicitet
English: • if you had prior treatment of the chest with radiation;
Danish: • - hvis du tidligere har fået strålebehandling af brystet.
English: Topoisomerase II inhibitors (a groups of anticancer medicines including mitoxantrone) in combination with other chemotherapy and/or radiotherapy.
Danish: - Topoisomerase II-hæmmere (en gruppe kræftlægemidler, herunder mitoxantron) i kombination med anden kemoterapi og/eller strålebehandling.
English: Treatment with mitoxantrone 12 mg/m² administered every three months was superior to 5 mg/m² and placebo in one clinical study with highly active inflammatory active MS disease.
Danish: Behandling med mitoxantron 12 mg/m² indgivet hver tredje måned var superiort i forhold til 5 mg/m² og placebo i et klinisk studie med højaktiv inflammatorisk aktiv MS. Der blev observeret en reduktion i forværring af neurologisk handicap og hyppighed af kliniske relapser.
English: Anxiety Confusion Headache Paraesthesia
Danish: Angst Konfusion Hovedpine Paræstesi
English: Myelosuppression may be more severe and prolonged in patients with poor general condition, or prior chemotherapy and/or radiotherapy.
Danish: Myelosuppression kan være sværere og mere langvarig hos patienter med dårlig almentilstand og patienter, der tidligere har fået kemoterapi og/eller strålebehandling.
English: The recommended dosage of mitoxantrone is usually 12 mg/m2 body surface area given as a short
Danish: Den anbefalede dosis mitoxantron er normalt 12 mg/m2 kropsoverflade, indgivet som en kortvarig (ca.
English: Common (may affect up to 1 in 10 people) - Low number of red blood cells which can cause a feeling of tiredness and shortness of breath
Danish: Almindelig (kan påvirke op til 1 ud af 10 personer) - Lavt antal røde blodlegemer, som kan give en følelse af træthed og åndenød (anæmi).
English: Women of childbearing potential should be informed about increased risk of transitory or persistent amenorrhoea (see section 4.6).
Danish: Fertilitet Kvinder i den fertile alder skal informeres om øget risiko for forbigående eller vedvarende amenore (se pkt.
English: (12 mg/m2 or less) is recommended in patients with inadequate bone marrow reserves e.g. due to prior chemotherapy or poor general condition.
Danish: mg/m2 eller mindre) anbefales til patienter med utilstrækkelige knoglemarvsreserver, f.eks. på grund af tidligere kemoterapi eller dårlig almentilstand.
English: This infection should be treated before taking Novantrone; if you plan a vaccination or immunisation during treatment.
Danish: - - hvis du planlægger en vaccination eller immunisering under behandlingen.
English: Mitoxantrone clearance may be reduced by hepatic impairment.
Danish: Mitoxantron-clearance kan blive reduceret ved nedsat leverfunktion.
English: Congestive heart failure Cardiomyopathy Sinus bradycardia Myocardial infarction (including fatal events)
Danish: Kongestivt hjertesvigt Kardiomyopati Sinusbradykardi Myokardieinfarkt (herunder med dødelig udgang)
English: - Irregular heart beat.
Danish: hjerteflimmer (uregelmæssig hjerterytme).
English: Carcinogenic effects were seen in rat and in male mice.
Danish: Karcinogene effekter blev iagttaget hos rotter og hanmus.
English: The pharmacokinetics of mitoxantrone in patients following single-dose intravenous administration can be characterised by a three-compartment model.
Danish: Efter indgivelse af en intravenøs enkeltdosis til patienter kan mitoxantrons farmakokinetik karakteriseres ved en tre-kompartmentmodel.
English: Mitoxantrone is indicated for treatment of patients with highly active relapsing multiple sclerosis associated with rapidly evolving disability where no alternative therapeutic options exist (see sections 4.2, 4.4 and 5.1).
Danish: Mitoxantron er indiceret til behandling af patienter med højaktiv recidiverende dissemineret sclerose i forbindelse med hastigt udviklende handicap, hvor der ikke findes alternative terapeutiske muligheder (se pkt.
English: - Abnormal results of blood tests to check liver function (raised aspartate aminotransferase levels).
Danish: Du har ingen symptomer - Unormale resultater af blodprøver for leverfunktion (forhøjet aspartat-aminotrasferase)
English: Secondary acute myeloid leukaemia and myelodysplastic syndrome Topoisomerase II inhibitors, including mitoxantrone, when used as monotherapy or especially concomitantly with other antineoplastic agents and/or radiotherapy, have been associated with the development of Acute Myeloid Leukaemia or Myelodysplastic Syndrome.
Danish: Sekundær akut myeloid leukæmi og myelodysplastisk syndrom Topoisomerase II-inhibitorer, herunder mitoxantron, er, når de anvendes som monoterapi eller i særdeleshed i kombination med andre antineoplastiske præparater og/eller strålebehandling, blevet forbundet med udviklingen af akut myeloid leukæmi eller myelodysplastisk syndrom.
English: Hence, patients with multiple sclerosis should not receive a lifetime cumulative dose greater than 72 mg/m².
Danish: Derfor bør patienter med dissemineret sklerose højst have en kumulativ livstidsdosis på 72 mg/m2.
English: The maximum lifetime cumulative dose should not exceed 72 mg/m2.
Danish: Den maksimale kumulative (samlede) livstidsdosis bør ikke overstige 72 mg/m2.
English: For induction, the recommended dosage is 12 mg/m2 of mitoxantrone daily on Days 1 to 3 given as an intravenous infusion, and 100 mg/m2 of cytarabine for 7 days given as a continuous 24-hour infusion on Days 1 to 7.
Danish: Til induktion er den anbefalede dosis 12 mg/m2 mitoxantron som intravenøs infusion dagligt på dag 1 til 3 og 100 mg/m2 cytarabin som kontinuerlig 24-timers infusion i 7 dage på dag 1 til 7.
English: Discolouration of urine and other tissues
Danish: Farveændring af urin og væv
English: • if you have a low count of a specific type of white blood cells (neutrophils) (less than
Danish: • du har et lavt antal af en specifik type hvide blodlegemer (neutrofiler) (under 1.500 celler/mm3).
English: As a guide, when mitoxantrone is used in combination chemotherapy with another myelosuppressive agent, the initial dose of mitoxantrone should be reduced by 2 to 4 mg/m2 below the doses recommended for single agent usage; subsequent dosing, as outlined in the table above, depends on the degree and duration of myelosuppression.
Danish: Når mitoxantron anvendes i kombinationskemoterapi med et andet myelosuppressivt præparat, bør begyndelsesdosis af mitoxantron vejledende reduceres med 2-4 mg/m2 under de anbefalede doser ved monoterapi; efterfølgende dosering afhænger som skitseret i tabellen ovenfor af graden af myelosuppression og dens varighed.
English: Acute myeloid leukaemia:
Danish: Akut myeloid leukæmi:
English: Constipation Diarrhoea Stomatitis
Danish: Obstipation Diarré Stomatitis
English: In metastatic breast cancer, combinations of Novantrone with other cytotoxic agents including cyclophosphamide and 5-fluorouracil or methotrexate and mitomycin C have been shown to be effective.
Danish: Ved metastatisk brystkræft er det påvist, at kombination af Novantrone med andre cytotoksiske præparater, herunder cyclophosphamid og 5fluoruracil eller methotrexat og mitomycin C er effektive.
English: - Low number of special white blood cells (neutrophils and leukocytes) - Nausea (feeling sick).
Danish: Det kan blive nødvendigt med en blodtransfusion - Lavt antal af specielle hvide blodlegemer (neutrofiler og leukocytter) - Kvalme - Opkastning - Hårtab
English: In metastatic breast cancer, combinations of mitoxantrone with other cytotoxic agents including cyclophosphamide and 5-fluorouracil or methotrexate and mitomycin C have been shown to be effective.
Danish: Ved metastatisk brystcancer er det påvist, at kombinationer af mitoxantron med andre cytotoksiske præparater, herunder cyclophosphamid og 5fluoruracil eller methotrexat og mitomycin C er effektive.
English: The maximum lifetime cumulative dose should not exceed 72 mg/m2 (see section 5.1).
Danish: Den maksimale kumulerede livstidsdosis bør ikke overstige 72 mg/m2 (se pkt.
English: Urinary tract infection Upper respiratory tract infection Sepsis
Danish: Urinvejsinfektion Øvre luftvejsinfektion Sepsis
English: Mitoxantrone should not ordinarily be not receive a lifetime cumulative dose greater than 72 mg/m administered to multiple sclerosis patients, with either LVEF of < 50% or a clinically-significant reduction in LVEF.
Danish: Generelt må mitoxantron ikke indgives til patienter med dissemineret sklerose med enten LVEF < 50 % eller en klinisk signifikant reduktion i LVEF.
English: If WBC nadir > 1,500 µl and platelet nadir > 50,000 µl
Danish: Hvis WBC-nadir > 1.500 µl og blodplade-nadir > 50.000 µl
English: [See Annex I - To be completed nationally] {Name and address} {tel} {fax} {e-mail}
Danish: [Se bilag I - udfyldes nationalt] {Navn og adresse} Tlf: +(Tlfnr.)
English: Mitoxantrone must not be used in treatment of multiple sclerosis in pregnant women (see sections 4.4 and
Danish: Mitoxantron må ikke anvendes til behandling af dissemineret sklerose hos gravide kvinder (se pkt.
English: • cancer of white blood cells (acute myeloid leukaemia, AML)
Danish: • Kræft i hvide blodlegemer (akut myeloid leukæmi, AML).
English: Signs and symptoms of infection and differential blood count with WHO grade 1: following dose 9 mg/m² Signs and symptoms of infection and differential blood count with WHO grade 2: following dose 6 mg/m²
Danish: Differential blodtælling 7 dage før mitoxantroninfusion Tegn og symptomer på infektion og differential blodtælling med WHO-grad 1: efterfølgende dosis 9 mg/m Tegn og symptomer på infektion og differential blodtælling med WHO-grad 2: efterfølgende dosis 6 mg/m2 Tegn og symptomer på infektion og differential blodtælling med WHO-grad 3-4: seponér behandlingen
English: If WBC nadir < 1,000 µl or platelet nadir < 25,000 µl
Danish: Hvis WBC-nadir < 1.000 µl eller blodplade-nadir < 25.000 µl
English: Decrease by 2 mg/m2 from prior dose, after recovery.
Danish: Efter restitution nedsættes dosis med 2 mg/m2 i forhold til tidligere dosis.
English: If WBC nadir < 1,500 µl or platelet nadir < 50,000 µl
Danish: Hvis WBC-nadir < 1.500 µl eller blodplade-nadir < 50.000 µl
English: Novantrone and associated names (see Annex I) 2 mg/ml concentrate for solution for infusion [See Annex I - To be completed nationally]
Danish: Novantrone og relaterede navne (se bilag I) 2 mg/ml koncentrat til infusionsvæske, opløsning [Se bilag I - udfyldes nationalt]
English: Sinus bradycardia Electrocardiogram abnormal Left ventricular ejection fraction decreased
Danish: Sinusbradykardi Abnormt elektrokardiogram Nedsat venstre ventrikel uddrivningsfraktion
English: Novantrone should be administered under the supervision of a doctor experienced in the use of cancer medicines that are toxic to your cells (cytotoxic chemotherapy agents).
Danish: Novantrone skal indgives under tilsyn af en læge, der har erfaring med brug af kræftmedicin, der er giftig for dine celler (cytotoksiske kemoterapipræparater).
English: Novantrone concentrate must not be given subcutaneously, intramuscularly, or intra-arterially.
Danish: Novantronekoncentrat må ikke indgives subkutant, intramuskulært eller intraarterielt.
English: Elevated serum creatinine Elevated blood urea nitrogen levels
Danish: Forhøjet serumkreatinin Forhøjet blodureanitrogen Toksisk nefropati Farveændring af urin
English: Mitoxantrone administered at any dose can cause myelosuppression.
Danish: Uanset dosis kan mitoxantron forårsage myelosuppression.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Novantrone and associated names (see Annex I) 2 mg/ml concentrate for solution for infusion [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Novantrone og relaterede navne (se bilag I) 2 mg/ml koncentrat til infusionsvæske, opløsning [Se bilag I - udfyldes nationalt]
English: Novantrone and associated names (see Annex I) 2 mg/ml concentrate for solution for infusion [See Annex I - To be completed nationally] Mitoxantrone
Danish: Novantrone og relaterede navne (se bilag I) 2 mg/ml koncentrat til infusionsvæske, opløsning [Se bilag I - udfyldes nationalt] Mitoxantron
English: Treatment of blast crisis in (chronic) myeloid leukaemia Single dose therapy in relapse
Danish: Behandling af blastkrisen i (kronisk) myeloid leukæmi Monoterapi ved relaps
English: Differential blood count within 21 days after mitoxantrone infusion Signs and symptoms of infection and differential blood count with WHO grade 3: following dose 10 mg/m²
Danish: Differentialtælling inden for 21 dage efter mitoxantroninfusion Tegn og symptomer på infektion og differential blodtælling med WHO-grad 3: efterfølgende dosis 10 mg/m2 Tegn og symptomer på infektion og differential blodtælling med WHO-grad 4: efterfølgende dosis 8 mg/m
English: Consolidation therapy, which was used in two large randomised multicentre trials, consists of mitoxantrone 12 mg/m2 given by intravenous infusion daily on Days 1 and 2, and cytarabine, 100 mg/m2
Danish: Konsolideringsterapi, som blev anvendt i to store randomiserede multicenterforsøg, består af mitoxantron 12 mg/m2 som intravenøs infusion dagligt på dag 1 og 2 og cytarabin 100 mg/m2 som kontinuerlig 24-timers infusion i 5 dage på dag 1 til 5.
English: Multiple sclerosis population
Danish: Population med dissemineret sklerose
English: • a bone marrow disorder that causes abnormally shaped blood cells and leads to leukaemia (myelodysplastic syndrome)
Danish: • En knoglemarvssygdom, der giver unormalt formede blodceller og resulterer i leukæmi (myelodysplastisk syndrom).
English: Therefore men under therapy must be advised not to father a child and to use contraceptive measures during and at least 6 months after therapy.
Danish: Derfor skal mænd tilrådes ikke at besvangre en kvinde under behandlingen og at anvende prævention under og mindst 6 måneder efter behandlingen.
English: Leukopenia Granulocytopenia White blood cell count abnormal
Danish: Leukopeni Granulocytopeni Abnorme leukocyttal
English: Women of child-bearing potential should have a negative pregnancy test prior to each dose and must practise effective contraception for at least 4 months after stopping the treatment with Novantrone.
Danish: Kvinder i den fødedygtige alder skal have en negativ graviditetstest før hver dosis samt bruge effektiv prævention i mindst 4 måneder efter, behandlingen med Novantrone er afsluttet.
English: Fatigue Pyrexia
Danish: Asteni Træthed Pyreksi
English: Tumour lysis syndrome
Danish: Tumor lysis-syndrom (TLS)
English: - Taste disturbances.
Danish: - - hvis du har nyreproblemer.
English: As a guide, when Novantrone is used in combination chemotherapy, the initial dose of Novantrone should be reduced by 2-4 mg/m2 below the doses recommended when Novantrone is used alone.
Danish: Når Novantrone anvendes i kombinationskemoterapi med et andet myelosuppressivt præparat, bør begyndelsesdosis af Novantrone vejledende reduceres med 2-4 mg/m2 i forhold til de anbefalede doser, når
English: Cancer patients who received cumulative doses of 140 mg/m2 either alone or in combination with other chemotherapeutic agents had a cumulative 2.6% probability of clinical congestive heart failure.
Danish: Cancerpatienter, der fik kumulerede doser på 140 mg/m2 enten alene eller i kombination med andre kemoterapeutika, havde en kumulativ 2,6 % sandsynlighed for klinisk kongestivt hjertesvigt.
English: The treatment with mitoxantrone should be administered under the supervision of a physician experienced in the use of cytotoxic chemotherapeutic agents for the treatment of multiple sclerosis.
Danish: Behandling med mitoxantron skal administreres under supervision af en læge med erfaring i anvendelse af cytotoksiske kemoterapeutika til behandling af dissemineret sklerose.
English: Congestive heart failure Myocardial infarction (including fatal events)
Danish: Kongestivt hjertesvigt Myokardieinfarkt (herunder med dødelig udgang)