FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will do heart function tests before you start Novantrone and at regular intervals during therapy.
Danish: Lægen vil undersøge din hjertefunktion, før du starter behandling med Novantrone, og regelmæssigt under behandlingen.
English: Novantrone should be given by slow and freely flowing infusion into the vein.
Danish: Novantrone skal indgives ved langsom og fritløbende infusion i en vene.
English: Mitoxantrone may cause a blue-green colouration to the urine for 24 hours after administration, and patients should be advised to expect this during therapy.
Danish: Mitoxantron kan forårsage en blågrøn farvning af urinen i 24 timer efter indgivelse, og patienterne skal informeres om at forvente dette under behandlingen.
English: Mitoxantrone and its metabolites are excreted in bile and urine, but it is not known whether the metabolic or excretory pathways are saturable, may be inhibited or induced, or if mitoxantrone and its metabolites undergo enterohepatic circulation (see section 5.2).
Danish: Mitoxantron og dets metabolitter udskilles i galde og urin, men det er ikke kendt, om de metaboliske eller ekskretoriske eliminationsveje kan mættes, kan hæmmes eller induceres, eller om mitoxantron og dets metabolitter undergår enterohepatisk cirkulation (se pkt.
English: Haematopoietic, gastrointestinal, hepatic or renal toxicity may be seen, depending on the dosage given and the physical condition of the patient.
Danish: Toksicitet på hæmatopoiese, mave-tarm, lever og nyrer kan ses, afhængigt af den givne dosis og patientens fysiske tilstand.
English: Mitoxantrone has also been used in various combinations for non-Hodgkin's lymphoma; however, data are presently limited and specific regimens cannot be recommended.
Danish: Mitoxantron er også blevet anvendt i forskellige kombinationer til non-Hodgkin-lymfom; data er dog begrænsede i øjeblikket, og specifikke regimer kan ikke anbefales.
English: Haematological toxicity is difficult to evaluate in acute leukaemia because traditional parameters of bone marrow depression such as white blood cell and platelet counts are confounded by marrow replacement with leukemic cells.
Danish: Hæmatologisk toksicitet er vanskelig at vurdere ved akut leukæmi, fordi traditionelle parametre for knoglemarvsdepression, såsom leukocyt- og trombocyttal, bliver påvirket af udskiftning af cellerne i knoglemarven med leukæmiceller.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Mitoxantrone [To be completed nationally]
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Mitoxantron [Udfyldes nationalt]
English: In a pharmacokinetic study in children with de novo acute myeloid leukaemia, ciclosporin co-medication resulted in a 42% decreased clearance of mitoxantrone.
Danish: I et farmakokinetisk studie hos børn med de novo akut myeloid leukæmi resulterede samtidig behandling med ciclosporin i et fald i mitoxantron-clearance på 42 %.
English: In case of non-haematological toxicities WHO grade 2 to 3 the following dose should be adjusted to 10 mg/m2, in case of non-haematological toxicity grade 4 the treatment should be discontinued.
Danish: I tilfælde af ikke-hæmatologiske toksiciteter af WHO-grad 2-3 skal den efterfølgende dosis reguleres til 10 mg/m2; i tilfælde af ikke-hæmatologisk toksicitet af grad 4 skal behandlingen seponeres.
English: Inhibitors of the BCRP transporter (e.g. eltrombopag, gefitinib) could result in an increased bioavailability.
Danish: Hæmmere af BCRPtransportproteinet (f.eks. eltrombopag, gefitinib) kan resultere i øget biotilgængelighed.
English: o Reddening (erythema).
Danish: o Rødme (erytem)
English: Mitoxantrone in combination with cytarabine as initial induction treatment is at least as effective for inducing remission as daunorubicin combinations in adult patients with previously untreated AML.
Danish: Mitoxantron kombineret med cytarabin som initial induktionsbehandling er i det mindste lige så effektivt til at fremkalde remission hos voksne patienter med tidligere ubehandlet AML som kombinaitoner med daunorubicin.
English: These reports have included seizures leading to coma and severe neurologic sequelae, and paralysis with bowel and bladder dysfunction.
Danish: Disse indberetninger har omfattet krampeanfald, der medførte koma og svære, neurologiske sequalae, samt paralyse med nedsat tarm- og blærefunktion.
English: A lower initial dosage
Danish: En lavere begyndelsesdosis (12
English: For subsequent courses, the prior dose can usually be repeated if white blood cell and platelet counts have returned to normal levels after 21 days.
Danish: Ved efterfølgende behandlingsforløb kan den tidligere dosis sædvanligvis gentages, hvis tallene for de hvide blodlegemer og blodplader er vendt tilbage til normale niveauer efter 21 dage.
English: Mitoxantrone, a synthetic anthracenedione derivative, is an established cytotoxic, antineoplastic agent.
Danish: Mitoxantron, der er et syntetisk antracendion-derivat, er et dokumenteret cytotoksisk antineoplastisk stof.
English: If this medicinal product is used during pregnancy or if the patient becomes pregnant while taking mitoxantrone, the patient should be informed of the potential risk to the foetus and genetic counselling should be provided.
Danish: Hvis dette lægemiddel anvendes under graviditet, eller hvis patienten bliver gravid, mens hun er i behandling med mitoxantron, skal hun informeres om den potentielle risiko for fosteret, og der bør ydes genetisk rådgivning.
English: Mitoxantrone was mutagenic and clastogenic in all in vitro test systems and in rats in vivo.
Danish: Mitoxantron var mutagent og klastogent i alle in vitro testsystemer og hos rotter in vivo.
English: Because of the possible danger of cardiac effects in patients previously treated with daunorubicin or doxorubicin, the benefit-to-risk ratio of mitoxantrone therapy in such patients should be determined before starting therapy.
Danish: På grund af den mulige fare ved kardiale effekter hos patienter, der tidligere er blevet behandlet med daunorubicin eller doxorubicin, skal benefit/risk-forholdet ved mitoxantronbehandling hos sådanne patienter bestemmes, før behandlingen påbegyndes.
English: If you receive Novantrone to treat multiple sclerosis your doctor will test your heart function before the start of therapy, prior to each subsequent dose and yearly for up to 5 years after the end of therapy.
Danish: Hvis du får Novantrone til behandling af dissemineret sklerose, vil lægen undersøge hjertefunktionen før behandlingens start, før hver efterfølgende dosis og årligt i op til 5 år efter, behandlingen er afsluttet.
English: Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic medicinal products may increase the risk of cardiac toxicity.
Danish: Aktiv eller latent kardiovaskulær sygdom, tidligere eller samtidig strålebehandling på det mediastinale/perikardiale område, tidligere behandling med andre antracykliner eller antracendioner eller samtidig anvendelse af andre kardiotoksiske lægemidler kan øge risikoen for kardiotoksicitet.
English: In patients receiving oral anticoagulant therapy, the prothrombin time ratio or INR should be closely monitored with the addition and withdrawal of treatment with mitoxantrone and should be reassessed more frequently during concurrent therapy.
Danish: Hos patienter, der får orale antikoagulantia, skal protrombintid-forholdet eller INR nøje monitoreres ved tilføjelse og seponering af mitoxantron og skal revurderes hyppigere under sideløbende terapi.
English: Heart, kidney, gastrointestinal tract, and testes were additional targets.
Danish: Hjerte, nyrer, mave-tarm-kanal og testes var yderligere målorganer.
English: Contusion Haemorrhage Hypotension
Danish: Kontusion Hæmoragi Hypotension
English: In addition your blood will be tested regularly during the treatment.
Danish: Endvidere vil dit blod blive undersøgt regelmæssigt under behandlingen, og dosen vil blive reguleret i overensstemmelse med resultaterne af disse prøver.
English: If this medicine is used during pregnancy or if you become pregnant while taking this medicine, inform your doctor as there may be risks to the foetus.
Danish: Hvis denne medicin bruges under graviditet, eller hvis du bliver gravid, mens du bruger denne medicin, skal du fortælle det til lægen, da der kan være en risiko for fostret.
English: However, cardiotoxicity increases with cumulative doses.
Danish: Kardiotoksicitet øges imidlertid med kumulerede doser.
English: If Novantrone is used alone:
Danish: Novantrone bruges alene.
English: Myelosuppression can be more pronounced and longer-lasting in patients who have previously received chemotherapy or radiotherapy.
Danish: Myelosuppression kan være mere udtalt og længerevarende hos patienter, der tidligere har fået kemoterapi eller strålebehandling.
English: Severe local tissue damage may occur if Novantrone leaks in surrounding tissue (extravasation) during administration.
Danish: Svær lokal vævsskade kan forekomme, hvis Novantrone lækker ud i det omgivende væv (ekstravasation) under indgivelsen.
English: Rare (may affect up to 1 in 1,000 people) None.
Danish: Sjælden (kan påvirke mere end 1 ud af 1000 personer) Ingen
English: Mitoxantrone is indicated for the treatment of acute myeloid leukaemia (AML) in adults.
Danish: Mitoxantron er indiceret til behandling af akut myeloid leukæmi (AML) hos voksne.
English: In men, no data are available, but tubular atrophy of the testes and reduced sperm counts were observed in animals (see section 5.3).
Danish: Hos mænd findes ingen tilgængelige data, men tubulær atrofi i testes og reducerede spermtal blev observeret hos dyr (se pkt.
English: Sudden death** * Extravasation at the infusion site has been reported, which may result in erythema, swelling, pain, burning and/or blue discolouration of the skin.
Danish: * Der er blevet indberettet ekstravasation på infusionsstedet, som kan resultere i erytem, hævelse, smerter, brændende fornemmelse og/eller blåfarvning af huden.
English: Mitoxantrone has been given as part of combination therapy.
Danish: Mitoxantron er blevet givet som del af kombinationsterapi.
English: The recommended initial dosage of Novantrone is 14 mg/m2 of body surface area, given as a single intravenous dose, which may be repeated at 21-day intervals, if your blood values have returned to acceptable levels.
Danish: Den anbefalede begyndelsesdosis af Novantrone er 14 mg/m kropsareal, indgivet som en enkelt intravenøs dosis, der kan gentages med intervaller på 21 dage, hvis dine blodværdier er vendt tilbage til acceptable niveauer.
English: The fraction bound is independent of concentration and is not affected by the presence of phenytoin, doxorubicin, methotrexate, prednisone, prednisolone, heparin, or aspirin.
Danish: Den bundne fraktion er koncentrationsuafhængig og påvirkes ikke af tilstedeværelse af phenytoin, doxorubicin, methotrexat, prednison, prednisolon, heparin eller acetylsalicylsyre.
English: Mitoxantrone is indicated in the treatment of metastatic breast cancer.
Danish: Mitoxantron er indiceret til behandling af metastatisk brystcancer.
English: Mitoxantrone in combination with other cytostatic active substances is effective in the treatment of metastatic breast cancer, also in patients who failed adjuvant therapy with an anthracycline-containing regimen.
Danish: Mitoxantron i kombination med andre cytostatiske stoffer er effektivt til behandling af metastatisk brystcancer, også hos patienter, hvor adjuverende terapi med et antracyklinholdigt regime er mislykket.
English: Evaluation of the left-ventricular ejection fraction (LVEF) by echocardiogram or multiple-gated acquisition (MUGA) is recommended prior to administration of the initial dose of mitoxantrone in cancer patients.
Danish: Vurdering af venstre ventrikels uddrivningsfraktion (LVEF) ved hjælp af ekkokardiogram eller MUGA (multiple gated data acquisition) anbefales før administration af første mitoxantrondosis til cancerpatienter.
English: In general, dose selection for an elderly patient should be initiated at the low end of the dosing range, reflecting the greater frequency of decreasing hepatic, renal, or cardiac function, and of concomitant disease or treatment with other medicinal products.
Danish: I almindelighed skal dosering til en ældre patient initieres i den lave ende af dosisintervallet og afspejle den større hyppighed af nedsat lever-, nyre- og hjertefunktion og af samtidig sygdom eller behandling med andre lægemidler.
English: The most serious side effects with mitoxantrone are myocardial toxicity and myelosuppression.
Danish: De alvorligste bivirkninger ved mitoxantron er myokardietoksicitet og myelosuppression.
English: Date of first authorisation: {DD month YYYY} Date of latest renewal: {DD month YYYY} [To be completed nationally]
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ} Dato for seneste fornyelse: {DD måned ÅÅÅÅ} [Udfyldes nationalt]
English: The pathways leading to the metabolism of mitoxantrone have not been elucidated.
Danish: Metaboliseringsvejene for mitoxantron er ikke blevet belyst.
English: Abdominal pain Gastrointestinal haemorrhage Mucosal inflammation Pancreatitis
Danish: Abdominalsmerter Gastrointestinal hæmoragi Mucosainflammation Pankreatitis
English: Mitoxantrone in combination regimens is indicated in the remission-induction treatment of blast crisis in chronic myeloid leukaemia.
Danish: Mitoxandron i et kombinationsregime er indiceret til remissions-induktionsbehandling af blastkrisen i kronisk myeloid leukæmi.
English: The medicinal product must also not be given by intrathecal injection.
Danish: Lægemidlet må ikke indgives ved intratekal injektion.
English: For patients being treated for Multiple Sclerosis:
Danish: For patienter i behandling for dissemineret sklerose:
English: Mitoxantrone
Danish: Mitoxantron
English: If mitoxantrone is administered repeatedly, dosing adjustments should be guided by extent and duration of the reduction in the number of white and red blood cells as well as platelets in your blood.
Danish: Hvis mitoxantron indgives flere gange, bør dosisregulering styres af reduktionen i antal hvide og røde blodlegemer samt blodplader i blodet.
English: Novantrone concentrate should be slowly injected into a free flowing intravenous infusion of isotonic saline or 5% glucose solution over a period of not less than 3 to 5 minutes.
Danish: Novantronekoncentrat skal injiceres langsomt i en fritløbende infusion af isoton natriumchlorid- eller 5 % glucoseinfusionsvæske over en periode på mindst 3 til 5 minutter.
English: You must not breast-feed while using mitoxantrone and for up to one month after the last administration.
Danish: Du må ikke amme, mens du bruger mitoxantron og i op til en måned efter sidste dosis.
English: Mitoxantrone may cause a blue-green colouration to the urine for 24 hours after administration.
Danish: Mitoxantron kan forårsage en blågrøn farvning af urinen i 24 timer efter indgivelse.
English: Acute congestive heart failure may occasionally occur in patients treated with mitoxantrone for acute myeloid leukaemia.
Danish: Akut kongestivt hjertesvigt kan undertiden forekomme hos patienter, der er behandlet med mitoxantron for akut myeloid leukæmi.
English: Subsequent dosing
Danish: Efterfølgende dosis
English: Other medicines and Novantrone
Danish: Brug af anden medicin sammen med Novantrone
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and Address} {tel} {fax} {e-mail}
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - udfyldes nationalt] {Navn og adresse}
English: Weight fluctuations Tumour lysis syndrome*
Danish: Vægtfluktuationer Tumor lysis-syndrom*
English: Method of administration Novantrone concentrate should be given by intravenous infusion only.
Danish: Administration Novantronekoncentrat må kun indgives som intravenøs infusion.
English: Mitoxantrone is excreted in breast-milk and has been detected in breast-milk for up to one month after the last administration.
Danish: Mitoxantron udskilles i brystmælk og er blevet påvist i mælk i op til en måned efter sidste indgivelse.
English: The most serious side effects are damage to the heart (myocardial toxicity) and myelosuppression (reduced activity of the bone marrow).
Danish: De alvorligste bivirkninger er skade på hjertet (myokardietoksicitet) og myelosuppression (nedsat funktion af knoglemarven).
English: Myelosuppresion can be increased when it is used in combination chemotherapy with another myelosuppressive agent such as for treatment of breast cancer.
Danish: Myelosuppression kan forstærkes, når mitoxantron anvendes i kombinationskemoterapi med et andet myelosuppressivt præparat, f.eks. ved behandling af brystcancer.
English: In a clinical trial with acute leukaemia patients, significant myelosuppression occurred in all patients who were given mitoxantrone therapy.
Danish: I et klinisk forsøg med patienter med akut leukæmi forekom signifikant myelosuppression hos alle patienter, der fik mitoxantron.
English: Cases of congestive heart failure with left-ventricular ejection fraction (LVEF) < 50 % have also been reported (see section 4.4).
Danish: Tilfælde af kongestivt hjertesvigt med LVEF < 50 % er også blevet indberettet (se pkt.
English: Treatment with mitoxantrone is not recommended in the paediatric population.
Danish: Behandling med mitoxantron anbefales ikke i den pædiatriske population.
English: Mitoxantrone has been detected in breast-milk for up to one month after the last administration.
Danish: Mitoxantron er blevet påvist i brystmælk i op til en måned efter sidste indgivelse.
English: Therefore, live virus vaccines should not be administered during therapy.
Danish: Derfor må patienterne ikke vaccineres med levende virus-vacciner under behandlingen.
English: Extravasation can result in tissue necrosis with resultant need for debridement and skin grafting.
Danish: Ekstravasation kan resultere i vævsnekrose med efterfølgende behov for débridement og hudtransplantation.
English: The haematopoietic system was the primary target organ of toxicity showing myelosuppression.
Danish: Det hæmatopoietiske system var det primære målorgan for toksicitet og udviste myelosuppression.
English: PHARMACEUTICAL FORM Concentrate for solution for infusion [To be completed nationally]
Danish: LÆGEMIDDELFORM Koncentrat til infusionsvæske, opløsning [Udfyldes nationalt]
English: Based on data from two comparative trials of mitoxantrone plus corticosteroids versus corticosteroids alone, the recommended dosage of mitoxantrone is 12 to 14 mg/m2 given as a short intravenous infusion every 21 days, in combination with low oral doses of corticosteroids.
Danish: Baseret på data fra to komparative forsøg med mitoxantron plus kortikosteroider versus kortokosteroider alene er den anbefalede dosis mitoxantron 12-14 mg/m2 som en kortvarig intravenøs infusion hver 21. dag, i kombination med lave orale kortikosteroiddoser.
English: Fatal cases of Acute Myeloid Leukaemia (AML) have been reported (see section 4.4).
Danish: Dødelige tilfælde af akut myeloid leukæmi (AML) er blevet indberettet (se pkt.
English: This dose might be adjusted if: - The combination of medicines reduces the production of white and red blood cells as well as platelets in your bone marrow more than Novantrone used alone; - If you have serious liver or kidney problems.
Danish: Denne dosis kan blive reguleret, hvis: - kombinationen af lægemidler reducerer produktionen af hvide og røde blodlegeme samt blodplader i knoglemarven mere end Novantrone brugt alene.
English: Mitoxantrone must not be given by intrathecal injection.
Danish: Mitoxantron må ikke indgives ved intratekal injektion.
English: Novantrone must not be administered under the skin (subcutaneous), in a muscle (intramuscular), or into the artery (intra-arterial).
Danish: Novantrone må ikke indgives under huden (subkutant), i en muskel (intramuskulært) eller i en arterie (intraarterielt).
English: Advanced castrate-resistant prostate cancer
Danish: Fremskreden kastrat-resistent prostatakræft
English: Novantrone concentrate also can be administered as a short infusion (15 to 30 minutes) diluted in 50 to 100 ml isotonic saline or 5% glucose solution.
Danish: Novantronekoncentrat kan også indgives som kortvarig infusion (15-30 minutter) fortyndet i 50-100 ml isoton natriumchlorid- eller 5 % glucoseinfusionsvæske.
English: Tubular atrophy of the testes and decreased sperm counts were observed.
Danish: Tubulær atrofi i testes og reduceret spermtal blev observeret.
English: Severe injury with permanent sequelae can result from intrathecal administration.
Danish: Intratekal administration kan medføre svære skader med permanente sequalae.
English: Functional cardiac changes may occur in patients with multiple sclerosis treated with mitoxantrone.
Danish: Funktionelle, kardiale ændringer kan forekomme hos patienter med dissemineret sklerose, som er behandlet med mitoxantron.
English: When used for treatment in other indications mitoxantrone should not be administered during pregnancy in particular during the first trimester of pregnancy.
Danish: Ved andre indikationer må mitoxantron ikke indgives under graviditet, specielt ikke i første trimester.
English: There is no relevant use of mitoxantrone in the paediatric population.
Danish: Der er ingen relevant anvendelse af mitoxantron hos den pædiatriske population.
English: Mitoxantrone has been shown in vitro to inhibit B cell, T cell, and macrophage proliferation and impair antigen presentation, as well as the secretion of interferon gamma, tumour necrosis factor alpha, and interleukin-2.
Danish: Det er blevet påvist in vitro, at mitoxantron hæmmer B-celle-, T-celle- og makrofagproliferation og svækker antigenpræsentation samt sekretionen af interferon-gamma, tumornekrosefaktor-alfa og interleukin-2.
English: Because of the risk of development of secondary malignancies, the benefit-to-risk ratio of mitoxantrone therapy should be determined before starting therapy.
Danish: På grund af risikoen for udvikling af sekundære maligniteter skal benefit/risk-forholdet ved mitoxantronbehandling bestemmes, før behandlingen påbegyndes.
English: Safety and efficacy in paediatric patients have not been established.
Danish: Sikkerhed og virkning hos pædiatriske patienter er ikke blevet klarlagt.
English: Mitoxantrone is indicated in the treatment of non-Hodgkin's lymphoma.
Danish: Mitoxantron er indiceret til behandling af non-Hodgkin-lymfom.
English: Single doses ranged from 5 to 12 mg/m2, dose intervals from once per month to once per 3 months.
Danish: Enkeltdoser spændte fra 5 til 12 mg/m2, dosisintervaller fra en gang pr. måned til en gang pr. 3 måneder.
English: Confusion and fatigue may occur following administration of mitoxantrone (see section 4.8).
Danish: Konfusion og træthed kan forekomme efter indgivelse af mitoxantron (se pkt.
English: Mitoxantrone pharmacokinetics in the paediatric population is unknown.
Danish: Mitoxantrons farmakokinetik i den pædiatriske population kendes ikke.
English: What Novantrone contains
Danish: Novantrone indeholder:
English: Anaemia Neutropenia Leukopenia
Danish: Anæmi Neutropeni Leukopeni
English: In combination regimens mitoxantrone, in starting doses ranging from 7 to 8 to 10 to 12 mg/m2, dependent on the combination and frequency used, has shown effectiveness.
Danish: I kombinationsregimer har mitoxantron vist effektivitet ved startdoser fra 7-8 til 10-12 mg/m2, afhængigt af kombinationen og den anvendte doseringshyppighed.
English: Reproductive system and breast disorders Very common
Danish: Det reproduktive system og mammae Meget almindelig
English: A lower initial dosage (12 mg/m2 or less) is recommended in patients with low bone marrow reserves e.g. due to prior chemotherapy or poor general condition.
Danish: En lavere begyndelsesdosis (12 mg/m2 eller mindre) anbefales til patienter med utilstrækkelige knoglemarvsreserver, f.eks. på grund af tidligere kemoterapi eller dårlig almentilstand.