FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that frequent peripheral blood cell counts are performed on all patients receiving mitoxantrone in order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection.
Danish: Det anbefales at foretage hyppig tælling af perifere blodceller på alle patienter, der får mitoxantron, for at monitorere for forekomst af knoglemarvssuppression, især af neutropeni, som kan være alvorlig og resultere i infektion.
English: This treatment should be used only after assessment of the benefit-risk, particularly concerning the haematological and cardiac risks (see section 4.4).
Danish: Denne behandling bør kun anvendes efter vurdering af benefit/risk-forholdet, specielt vedrørende de hæmatologiske og kardiale risici (se pkt.
English: Mitoxantrone blocks the cell cycle in G2-phase leading to an increase of cellular RNA and polyploidy.
Danish: Mitoxantron blokerer cellecyklussen i G2-fasen, hvilket fører til en vækst af celle-RNA og polyploidi.
English: Novantrone prevents cancer cells from growing, as a result of which they eventually die.
Danish: Novantrone forhindrer cancerceller i at vokse, hvilket resulterer i, at de måske dør.
English: - Sudden death.
Danish: Pludselig død**
English: Very Common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 personer)
English: Dosage modification and the timing of subsequent dosing should be determined by clinical judgment depending on the degree and duration of myelosuppression.
Danish: Dosisændring og tidspunkt for efterfølgende dosis skal afgøres ved klinisk vurdering afhængigt af graden af myelosuppression og dens varighed.
English: Precautions to be taken before handling or administering the medicinal product Mitoxantrone should be given slowly into a freely flowing intravenous infusion.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Mitoxantron skal injiceres langsomt i en fritløbende intravenøs infusion.
English: Patients who receive immunosuppressive agents like mitoxantrone have a reduced immunological response to infection.
Danish: Patienter, der får immunsuppressiva som mitoxantron, har et nedsat immunologisk respons på infektion.
English: Novantrone contains the active substance mitoxantrone.
Danish: Novantrone indeholder det aktive stof mitoxantron.
English: There have been reports of local/regional neuropathy, some irreversible, following intra-arterial injection.
Danish: Der har været indberetninger om lokal/regional neuropati, hvoraf nogle irreversible, efter intraartiel injektion.
English: The treatment must not be initiated in patients who have been previously treated with mitoxantrone.
Danish: Behandlingen må ikke påbegyndes hos patienter, der tidligere er blevet behandlet med mitoxantron.
English: This may occur either during or months to years after therapy with Novantrone.
Danish: Dette kan forekomme enten under behandlingen eller måneder til år efter, behandlingen med Novantrone er afsluttet.
English: Novantrone must also not be injected into the space under the brain or spinal cord (intrathecal injection) as this can result in severe injury with permanent impairment.
Danish: Novantrone må heller ikke indsprøjtes i hulrummet under hjernen eller i rygsøjlen (intratekal injektion), da det kan resultere i svær skade med permanent funktionsnedsættelse.
English: Except for the treatment of acute myeloid leukaemia, mitoxantrone therapy generally should not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm3.
Danish: Undtagen ved behandling af akut myeloid leukæmi må mitoxantron generelt ikke gives til patienter med neutrofiltal under 1.500 celler/mm3 ved baseline.
English: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000
Danish: Hyppighederne er defineret i overensstemmelse med følgende konvention: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1,000 til < 1/100), sjælden (≥ 1/10,000 til < 1/1,000), meget sjælden (< 1/10,000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Mitoxantrone alone or in combination with other cytostatic medicinal products shows objective response in patients with several types of NHL.
Danish: Mitoxantron alene eller kombineret med andre cytostatiske lægemidler udviser objektivt respons hos patienter med flere typer NHL.
English: Mitoxantrone does not cross the blood-brain barrier.
Danish: Mitoxantron passerer ikke blod/hjerne-barrieren.
English: If used with other agents against cancer:
Danish: Hvis det bruges sammen med andre præparater mod kræft:
English: Therapy with mitoxantrone should be accompanied by close and frequent monitoring of haematological and chemical laboratory parameters, as well as frequent patient observation.
Danish: Behandling med mitoxantron skal ledsages af tæt og hyppig monitorering af hæmatologiske og kemiske laboratorieparametre samt af hyppig patientovervågning.
English: Mitoxantrone was not teratogenic in animal studies at doses below human exposure, but caused reproductive toxicity (see section 5.3).
Danish: Mitoxantron var ikke teratogent i dyrestudier ved doser under human eksponering, men forårsagede reproduktionstoksicitet (se pkt.
English: Bluish discolouration of the sclera, skin and nails may also occur.
Danish: Blålig farvning af sclera, hud og negle kan også forekomme.
English: There have been reports of neuropathy and neurotoxicity, both central and peripheral, following intrathecal injection.
Danish: Der har været indberetninger om neuropati og neurotoksicitet, både central og perifer, efter intratekal injektion.
English: Weight fluctuations * Acute T and B lymphoblastic leukaemia and non-Hodgkin lymphomas (NHL) are most commonly associated with TLS
Danish: Vægtfluktuationer * Akut T- og B-lymfoblastisk leukæmi og non-Hodgkin-lymfomer (NHL) er oftest associeret med TLS
English: Novantrone must not be used during pregnancy for treatment of multiple sclerosis (specifically in the first three months of the pregnancy).
Danish: Novantrone må ikke bruges under graviditet til behandling af dissemineret sklerose (specielt ikke i de første tre måneder af graviditeten).
English: If severe or life-threatening non haematological toxicity is observed during the first induction course, the second induction course shouldbe withheld until toxicity resolves.
Danish: Hvis der observeres svær eller livstruende ikkehæmatologisk toksicitet under det første induktionsforløb, skal det andet induktionsforløb først gives, når toksiciteten er ophørt.
English: Laboratory measurement cannot predict clearance of the active substance and dose adjustments (see section 5.2).
Danish: Laboratoriemåling kan ikke forudsige clearance af det aktive stof eller dosisjusteringer (se pkt.
English: There is no known specific antidote for mitoxantrone.
Danish: Der er ingen kendt specifik antidot mod mitoxantron.
English: Amenorrhoea * Amenorrhea may be prolonged and may be consistent with premature menopause General disorders and administration site conditions Common
Danish: Amenore * Amenore kan være forlænget og kan svare til præmatur menopause Almene symptomer og reaktioner på administrationsstedet Almindelig
English: Mitoxantrone is active when given alone or in combination with other anticancer agents or corticosteroids.
Danish: Mitoxantron er aktivt, når det gives alene eller i kombination med andre cancerpræparater eller kortikosteroider.
English: Single and repeat toxicity studies were conducted in mouse, rat, dog, rabbits, and monkey.
Danish: Studier af toksicitet efter enkeltdosis og gentagne doser blev gennemført hos mus, rotte, kaniner og abe.
English: • if you use Novantrone in high doses (>14 mg/m2 per day x 3 days).
Danish: • du bruger Novantrone i høje doser (>14 mg pr. kvadratmeter legemsoverflade pr. dag i 3 dage).
English: A bluish disolouration of the whites of your eyes, skin and nails may also occur.
Danish: Blålig farvning af det hvide i øjnene og af hud og negle kan også forekomme.
English: Plasma accumulation of active substance was not apparent when mitoxantrone was administered either daily for five days or as a single dose every three weeks.
Danish: Akkumulation af aktivt stof i plasma forekom tilsyneladende ikke, når mitoxantron blev indgivet enten dagligt i fem dage eller som en enkeltdosis hver tredje uge.
English: The long-term usefulness of mitoxantrone is limited by emerging cancer resistance which ultimately may result in fatal outcome when used as last-line therapy.
Danish: Mitoxantrons nytte på langt sigt er begrænset af nytilkommet cancerresistens, der ultimativt kan resultere i dødelig udgang, hvis det anvendes som sidste-linje-terapi.
English: Immunisation with live virus vaccines (e.g. yellow fever vaccination) increases the risk of infection and other adverse reactions such as vaccinia gangrenosa and generalized vaccinia, in patients with reduced immunocompetence, such as during treatment with mitoxantrone.
Danish: Immunisering med levende virus-vacciner (f.eks. gul feber-vaccination) øger risikoen for infektion og andre bivirkninger, såsom vaccinia gangrenosa og vaccinia generalisata, hos patienter med nedsat immunforsvar, f.eks. under behandling med mitoxantron.
English: The infusion liquid can leak out of the vein into the tissue (extravasation).
Danish: Infusionsvæsken kan lække fra venen ud i vævet (ekstravasation).
English: Mitoxantrone has been demonstrated to be a substrate for the BCRP transporter protein in vitro.
Danish: Det er blevet påvist, at mitoxantron er substrat for BCRP-transportproteinet in vitro.
English: The combination of mitoxantrone with other immunosuppressive agents may increase the risk of excessive immunodepression and lymphoproliferative syndrome.
Danish: Kombination af mitoxantron med andre immunsuppressiva kan øge risikoen for overdreven immundepression og lymfoproliferativt syndrom.
English: The most common side effects with mitoxantrone (seen in more than 1 patient in 10) are anaemia, leucopenia, neutropenia, infections, amenorrhoea, alopecia, nausea and vomiting.
Danish: De almindeligste bivirkninger ved mitoxantron (set hos flere end 1 patient ud af 10) er anæmi, leukopeni, neutropeni, infektioner, amenore, alopeci, kvalme og opkastning.
English: Vaccinations and immunisation (protection against the vaccination substances) may not work during treatment with Novantrone and for three months after the end of treatment.
Danish: Vaccinationer og immunisering (beskyttelse mod vaccine-stofferne) virker måske ikke under behandling med Novantrone og i 3 måneder efter, behandlingen er afsluttet.
English: The effect of gender, race, and renal impairment on mitoxantrone pharmacokinetics is unknown.
Danish: Indvirkning fra køn, race og nedsat nyrefunktion på mitoxantrons farmakokinetik kendes ikke.
English: The following table is suggested as a guide to dosage adjustment, in the treatment of metastatic breast cancer and non-Hodgkin's lymphoma according to haematological nadir (which usually occurs about 10 days after dosing).
Danish: Følgende tabel foreslås som vejledning til dosisjustering i behandlingen af metastatisk brystcancer og nonHodgkin-lymfom i overensstemmelse med hæmatologisk nadir (der sædvanligvis forekommer ca. 10 dage efter dosering).
English: Novantrone belongs to the group of medicines known as antineoplastic or anti-cancer medicines.
Danish: Novantrone tilhører en gruppe lægemidler, der kaldes antineoplastiske lægemidler eller cancer-lægemidler.
English: Mitoxantrone causes myelosuppression as an extension of its pharmacological action.
Danish: Mitoxantron forårsager myelosuppression som en udvidelse af dets farmakologiske virkning.
English: Cardiotoxicity can occur at any time during mitoxantrone therapy, and the risk increases with cumulative dose.
Danish: Kardiotoksicitet kan forekomme på ethvert tidspunkt under mitoxantronbehandling, og risikoen øges med kumulativ dosis.
English: Therefore, mitoxantrone has the potential to be carcinogenic in humans.
Danish: Derfor er mitoxantron potentielt karcinogent hos mennesker.
English: When mitoxantrone is used in high doses (> 14 mg/m2/d x 3 days) such as indicated for the treatment of leukaemia, severe myelosuppression will occur.
Danish: Når mitoxantron anvendes i høje doser (> 14 mg/m2/dag i 3 dage), f.eks. indiceret ved behandling af leukæmi, vil svær myelosuppression forekomme.
English: Novantrone is secreted into breast milk and may cause serious adverse reactions in your baby.
Danish: Novantrone udskilles i brystmælk og kan give alvorlige bivirkninger hos dit barn.
English: Cases of tumour lysis syndrome were reported with the use of mitoxantrone.
Danish: Der blev indberettet tilfælde af tumor lysis-syndrom ved anvendelse af mitoxantron.
English: The recommended dose is based on your body surface area, which is calculated in square metres (m2) using your height and weight.
Danish: Den anbefalede dosis er baseret på kroppens overfladeareal, som beregnes i kvadratmeter (m2) ud fra din højde og vægt.
English: Blood tests prior and during treatment with Novantrone Novantrone may affect your blood cell counts.
Danish: Blodprøver før og under behandling med Novantrone Novantrone kan påvirke dine blodtal.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of the vial contains 2 mg mitoxantrone (as hydrochloride).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml i hætteglas indeholder 2 mg mitoxantron (som hydrochlorid).
English: This dosage is given in 21 day-cycles, for induction therapy in AML during three consecutive days, for consolidation therapy during two days.
Danish: Denne dosis gives i 21-dages cykler til induktionsterapi ved AML i 3 konsekutive dage og til konsolideringsterapi i 2 dage.
English: • if you had previous therapies with anthracyclines or anthracenediones, such as daunorubicin or doxorubicin.
Danish: • - hvis du tidligere har fået behandlinger med antracykliner eller antracendioner, f.eks. daunorubicin eller doxorubicin.
English: This risk increases with cumulative dose.
Danish: Denne risiko øges med kumulativ dosis.
English: This medicine might increase the risk for transitory or persistent absence of menstruation (amenorrhoea) in women of childbearing age.
Danish: Denne medicin kan øge risikoen for forbigående eller vedvarende udeblivelse af menstruationen (amenore) hos kvinder i den fødedygtige alder.
English: In the several studies in multiple sclerosis the effective cumulative dose ranged from 36 mg/m to 120 mg/m2.
Danish: I adskillige studier hos patienter med dissemineret sklerose spændte den effektive kumulative dosis fra 36 mg/m2 til 120 mg/m2.
English: The combination of vitamin K antagonists and cytotoxic agents may result in an increased risk of bleeding.
Danish: Kombination af vitamin K-antagonister og cytotoksiske præparater kan resultere i en øget risiko for blødning.
English: Skin discolouration Tissue necrosis (after extravasation)
Danish: Misfarvning af hud Vævsnekrose (efter ekstravasation)
English: A complete blood count, including platelets, should be obtained prior to administration of the initial dose of mitoxantrone, 10 days following the administration and prior to each subsequent infusion and in the event that signs and symptoms of infection develop.
Danish: Fuldstændig blodtælling, herunder af blodplader, skal foretages før administration af initialdosis af mitoxantron, 10 dage efter indgivelse og før hver efterfølgende infusion samt i tilfælde af, at der optræder tegn og symptomer på infektion.
English: Mitoxantrone is excreted slowly in urine and faeces as either unchanged active substance or as inactive metabolites.
Danish: Mitoxantron udskilles langsom i urin og fæces som enten uomdannet aktivt stof eller som inaktive metabolitter.
English: Novantrone has also been used in various combinations for non-Hodgkin's lymphoma; however, data are presently limited and specific regimens cannot be recommended.
Danish: Novantrone er også blevet anvendt i forskellige kombinationer til non-Hodgkin-lymfom; data er dog i øjeblikket begrænsede, og specifikke regimer kan ikke anbefales.
English: {MM/YYYY} {DD/MM/YYYY} {DD month YYYY}
Danish: DATO FOR ÆNDRING AF TEKSTEN {MM/ÅÅÅÅ} {DD/MM/ÅÅÅÅ} {DD måned ÅÅÅÅ} [Udfyldes nationalt]
English: This also has been reported for MS patients treated with mitoxantrone.
Danish: Dette er også blevet indberettet for MS-patienter, der er behandlet med mitoxantron.
English: You should avoid contact with Novantrone, especially with the skin, mucous membranes (moist body surfaces, such as the lining of the mouth) and eyes.
Danish: Du skal undgå kontakt med Novantrone, især med hud, slimhinder (fugtige overflader i kroppen, f.eks. mundens inderside) og øjne.
English: Combining mitoxantrone with potentially cardiotoxic active substances (e.g. anthracyclines) increases the risk of cardiac toxicity.
Danish: Kombination af mitoxantron med potentielt kardiotoksiske aktive stoffer (f.eks. antracykliner) øger risikoen for kardiotoksicitet.
English: Not all pack sizes may be marketed.
Danish: 6.5 Emballagetype og pakningsstørrelser Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Myocardial toxicity, manifested in its most severe form by potentially irreversible and fatal congestive heart failure (CHF), may occur either during therapy with mitoxantrone or months to years after termination of therapy.
Danish: Myokardietoksicitet i den sværeste form med potentielt irreversibelt og dødeligt kongestivt hjertesvigt (CHF) kan forekomme enten under behandlingen med mitoxantron eller måneder til år efter afsluttet behandling.
English: Heart function tests prior and during treatment with Novantrone Novantrone may damage your heart and cause a deterioration of your heart function or in more severe cases heart failure.
Danish: Undersøgelse af hjertefunktionen før og under behandling med Novantrone Novantrone kan skade hjertet og forringe hjertefunktionen eller i alvorligere tilfælde give hjertesvigt.
English: Anaphylaxis/anaphylactoid reactions (including shock)
Danish: Anafylaksi/anafylaktoide reaktioner (herunder shock)
English: No teratogenic effects were observed in these studies, but the maximum doses tested were well below the recommended human dose (0.02 and 0.05 times in rats and rabbits, respectively, on an mg/m2
Danish: Der blev ikke observeret teratogene virkninger i disse studier, men de maksimale doser, der blev testet, var langt under den anbefalede humane dosis (0,02 og 0,05 gange hos hhv. rotter og kaniner på mg/m2-basis).
English: It also belongs to the subgroup of anti-cancer medicines called anthracyclines.
Danish: Det tilhører også en undergruppe af cancer-lægemidler, der kaldes antracykliner.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: Mitoxantrone in combination with corticosteroids improves pain control, and quality of life in patients with advanced castrate resistant prostate cancer, without any improvement in overall survival.
Danish: Mitoxantron kombineret med kortikosteroider forbedrer smertekontrol og livskvalitet hos patienter med fremskreden kastratresistent prostatacancer uden nogen forbedring i den samlede overlevelse.
English: (approximately 5 to 15 minutes) intravenous infusion that may be repeated every 1-3 months.
Danish: 5 til 15 minutter) intravenøs infusion, der kan gentages for hver 1-3 måneder.
English: However, in male animals, damage to the testes and decreased sperm counts were observed.
Danish: Hos dyrehanner er der imidlertid blevet observeret skade på testiklerne og nedsat spermtal.
English: Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA.
Danish: Mitoxantron vekselvirker også med ribonukleinsyre (RNA) og er en potent hæmmer af topoisomerase II, et enzym, der er ansvarligt for udfoldning og reparation af beskadiget DNA.
English: Mitoxantrone is genotoxic and is considered a potential human teratogen.
Danish: Mitoxantron er genotoksisk og anses for at have potentiel human teratogen effekt.
English: The safety and efficacy of mitoxantrone have not been studied after treatment with natalizumab, fingolimod, alemtuzumab, dimethyl fumarate, or teriflunomide.
Danish: Mitoxantrons sikkerhed og virkning er ikke blevet undersøgt efter behandling med natalizumab, fingolimod, alemtuzumab, dimethylfumarat eller teriflunomid.
English: Elderly patient should receive doses at the low end of the dosing range due to possible reduced liver, kidney or heart function and of possible illness or treatment with other medicines.
Danish: Ældre personer bør få doser i den lave ende af doseringsintervallet på grund af mulig nedsat funktion af lever, nyrer eller hjerte og af mulig sygdom eller behandling med andre lægemidler.
English: Systemic infections should be treated concomitantly with or just prior to commencing therapy with mitoxantrone.
Danish: Systemiske infektioner skal behandles samtidigt med eller umiddelbart før påbegyndelse af mitoxantronbehandling.
English: Four patients receiving 140 to 180 mg/m2 as a single bolus injection died as a result of severe leukopenia with infection.
Danish: Fire patienter, der fik 140 til 180 mg/m2 som en enkelt bolusinjektion, døde som følge af svær leukopeni med infektion.
English: In the event of an incomplete antileukaemic response, a second induction course may be given with mitoxantrone given for 2 days and cytarabine for 5 days, using the same daily dosage levels.
Danish: I tilfælde af et ufuldstændigt respons kan et nyt induktionsforløb gives med mitoxantron i 2 dage og cytarabin i 5 dage med anvendelse af de samme daglige dosisniveauer.
English: Cardiac toxicity with mitoxantrone may occur at lower cumulative doses whether or not cardiac risk factors are present.
Danish: Kardiotoksicitet med mitoxantron kan forekomme ved lavere kumulerede doser, uanset om der er kardiale risikofaktorer til stede eller ej.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl det til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: If any signs or symptoms of extravasation have occurred, including burning, pain, pruritus, erythema, swelling, blue discolouration, or ulceration, the administration should be stopped immediately (see section 4.4).
Danish: Hvis der er forekommet tegn eller symptomer på ekstravasation, herunder en brændende fornemmelse, smerter, pruritus, erytem, hævelse, blå misfarvning eller ulceration, skal infusionen straks standses (se pkt.
English: Inducers of the BCRP transporter could potentially decrease mitoxantrone exposure.
Danish: Induktorer af BCRP-transportproteinet kan potentielt nedsætte mitoxantroneksponeringen.
English: Women treated with Mitoxantrone have an increased risk of transitory or persistent amenorrhoea and therefore preservation of gametes should be considered prior to therapy.
Danish: Kvinder, der behandles med mitoxantron, har en øget risiko for forbigående eller vedvarende amenore, og derfor bør opbevaring af ægceller overvejes før behandling.
English: It is advised to use live virus vaccines with caution after stopping chemotherapy, and vaccinate not sooner than 3 months after the last dose of chemotherapy (see section
Danish: Der tilrådes forsigtighed ved vaccination med levende virus-vacciner efter ophør af kemoterapi og først vaccinere mindst 3 måneder efter sidste dosis kemoterapi (se pkt.
English: Acute myeloid leukaemia, myelodysplastic syndrome, acute leukaemia
Danish: Akut myeloid leukæmi, myelodysplastisk syndrom, akut leukæmi
English: Talk to your doctor or, pharmacist or nurse before using Novantrone:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Novantrone.