FrancophonIA/ELRC3.0 huggingface dataset:
English: While grade 3-4 neutropenia occurred in randomised trials more frequently among Pixuvri recipients, they were uncomplicated in the majority of cases, noncumulative and associated with a low incidence of febrile neutropenia or infections, none leading to fatal outcome.
Danish: I de randomiserede studier forekom neutropeni af grad 3-4 oftere hos personer behandlet med Pixuvri, men var i de fleste tilfælde ukompliceret, ikke-kumulativ og forbundet med en lav forekomst af febril neutropeni eller infektioner, ingen tilfælde resulterede i fatalt udfald.
English: This medicinal product contains approximately 1000 mg (43 mmol) sodium per dose after dilution.
Danish: Denne medicin indeholder ca. 1 000 mg (eller 43 mmol) natrium pr. dosis efter fortynding.
English: Patients in PIX 301 were required to have been sensitive to prior anthracycline therapy (confirmed or unconfirmed CR or PR).
Danish: Det var et krav, at patienterne i PIX 301 havde responderet på tidligere behandling med antracyclin (bekræftet eller ubekræftet komplet eller partiel respons).
English: Hydration, urine alkalinisation, and prophylaxis with allopurinol or other agents to prevent hyperuricaemia may minimise potential complications of tumour lysis syndrome.
Danish: Hydrering, alkalinisering af urinen og profylaktisk behandling med allopurinol eller andre midler til forebyggelse af hyperurikæmi kan minimere de potentielle komplikationer af tumorlysesyndromet.
English: The lyophilised powder should completely dissolve in 60 seconds with agitation.
Danish: Det frysetørrede pulver skal opløses fuldstændigt ved omrystning i 60 sekunder.
English: Pharmacokinetic/pharmacodynamic relationship(s) A relationship between plasma exposure to pixantrone and neutrophil count has been observed.
Danish: Farmakokinetiske/farmakodynamiske forhold Der er fundet sammenhæng mellem plasmaeksponering for pixantron og neutrofiltal.
English: Hepatic uptake of pixantrone is possibly mediated by OCT1 active transporters and biliary excretion by P-gp and BCRP.
Danish: Muligvis er den hepatiske optagelse af pixantron medieret af aktive OCT1- transportører, og den biliære udskillelse medieret af P-gp og BCRP.
English: Common Neutropenic infection, respiratory tract infection, infection, sepsis
Danish: Almindelig Neutropen infektion, luftvejsinfektion, infektion, sepsis
English: Patients treated with Pixuvri are likely to experience myelosuppression (neutropenia, leukopenia, anaemia, thrombocytopenia, and lymphopenia) with the predominant manifestation being neutropenia.
Danish: Patienter, der behandles med Pixuvri, må forventes at få myelosuppression (neutropeni, leukopeni, anæmi, trombocytopeni og lymfopeni) med neutropeni som den dominerende manifestation.
English: log rank p-value = 0.251 HR = 0.79 (95% CI 0.53, 1.18)
Danish: log rank p-value = 0.251 Risk ratio = 0,79 (95 % SI 0,53, 1,18)
English: Pixantrone had only a weak or no capability to inhibit P-gp, BCRP, and BSEP transport mechanism in vitro.
Danish: Pixantron var ikke eller kun ringe grad i stand til at hæmme transportmekanismerne P-gp, BCRP og BSEP in vitro.
English: One vial contains 39 mg sodium.
Danish: Hvert hætteglas indeholder 39 mg natrium.
English: If cardiac toxicity is demonstrated during treatment, the risk versus benefit of continued therapy with Pixuvri must be evaluated.
Danish: Påvises der kardiotoksicitet under behandlingen, skal benefit/risk-forholdet for videre behandling med Pixuvri vurderes.
English: However, the benefit of Pixuvri has not been established when used as fifth line or greater in patients refractory to last therapy, and there is very limited data in this group of patients.
Danish: Fordelen ved behandling med Pixuvri er imidlertid ikke dokumenteret ved anvendelse som femtevalg eller derover hos patienter, der er refraktære over for den senest anvendte terapi; for denne patientgruppe foreligger der kun meget begrænsede data.
English: Bronchitis, candidiasis, cellulitis, herpes zoster, meningitis, nail infection, oral fungal infection, oral herpes, pneumonia, salmonella gastroenteritis, septic shock
Danish: Bronkitis, candidiasis, cellulitis, herpes zoster, meningitis, negleinfektion, oral svampeinfektion, oral herpes, pneumoni, salmonella-gastroenteritis, septisk shock
English: Cardiac toxicity with Pixuvri may occur whether or not cardiac risk factors are present.
Danish: Kardiotoksicitet af Pixuvri kan forekomme uanset tilstedeværelse af kardielle risikofaktorer.
English: As with other agents in the general class of deoxyribonucleic acid (DNA) damaging agents, Pixuvri may be associated with fertility impairment.
Danish: Ligesom for andre midler i gruppen af deoxyribonukleinsyre- (DNA-) beskadigende midler kan behandling med Pixuvri være forbundet med nedsat fertilitet.
English: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood creatinine increased
Danish: Forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet basisk fosfatase i blodet, forhøjet kreatinin i blodet
English: The median overall survival for patients treated with Pixuvri was 2.6 months longer compared to patients treated with comparator (HR=0.79, logrank p=0.25) (see Figure 2 below).
Danish: Den mediane samlede overlevelse for patienter behandlet med Pixuvri var 2,6 måneder længere end for patienter behandlet med komparatorstofferne (risikoforhold = 0,79, logrank p = 0,25) (se figur 2 nedenfor).
English: Pixantrone may induce hyperuricaemia as a consequence of the extensive purine catabolism that accompanies drug-induced rapid lysis of neoplastic cells (tumour lysis syndrome) and can lead to electrolyte imbalances, which can result in kidney damage.
Danish: Pixantron kan inducere hyperurikæmi som følge af den ekstensive purinkatabolisme, der ledsager lægemiddelinduceret hurtig henfald af neoplastiske celler (tumorlysesyndrom) og kan forårsage elektrolytforstyrrelser med deraf følgende nyreskade.
English: All initial treatment with Pixuvri should be preceded by a careful baseline assessment of blood counts, serum levels of total bilirubin, serum levels of total creatinine, and cardiac function as measured by left ventricular ejection fraction (LVEF).
Danish: Før behandlingen med Pixuvri indledes, bør der altid foretages en omhyggelig baselinebestemmelse af blodbillede, total serumbilirubin, total serumkreatinin og hjertefunktion målt som venstre ventrikels uddrivningsfraktion (LVEF).
English: Careful monitoring of blood counts is required, including leukocyte, red blood cells, platelet, and absolute neutrophil counts.
Danish: Det er nødvendigt nøje at overvåge blodbilledet, herunder leukocyt-, erytrocyt-, trombocyt- og absolutte neutrofiltal.
English: Amitriptyline, haloperidol, clozapine, ondansetron and propranolol are metabolised by CYP1A2, and therefore, a theoretical concern exists that co-administration of Pixuvri may increase blood levels of this medicinal product.
Danish: Amitriptylin, haloperidol, clozapin, ondansetron og propranolol metaboliseres af CYP1A2, hvorfor koadministration af Pixuvri teoretisk kan frygtes at øge blodkoncentrationen af disse lægemidler.
English: log rank p-value = 0.005 HR = 0.60 (95% CI 0.42, 0.86)
Danish: log rank p-værdi = 0,005 Risk ratio = 0,60 (95 % SI 0,42, 0,86)
English: Blood uric acid levels, potassium, calcium phosphate, and creatinine should be evaluated after treatment in patients at high risk for tumour lysis (elevated LDH, high tumour volume, high baseline uric acid or serum phosphate levels).
Danish: Blodets indhold af urinsyre, kalium, calciumphosphat og kreatinin bør bestemmes efter behandling af patienter med høj risiko for tumorlyse (forhøjet LDH, stort tumorvolumen, høj baseline-værdi af urinsyre eller serumphosphat).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs http://www.ema.europa.eu hjemmeside.
English: From an analysis of population PK data, for a target recorded dose of 50 mg/m2 of pixantrone the median 28-day cycle exposure was 6320 ng.hr/ml (90% CI, 5990-6800 ng.hr/ml), for 3 doses / 4 week cycle.
Danish: Farmakokinetiske populationsdata viser, at med en registreret måldosis på 50 mg/m2 pixantron var den mediane eksponering i en 28-dages cyklus 6 320 ng.t/ml (90 % SI 5990-6 800 ng.t/ml) ved 3 doser i en 4-ugers cyklus.
English: Pixuvri must not be given to pregnant women as it may cause harm to unborn babies.
Danish: Pixuvri må ikke gives til gravide kvinder, dette kan skade fosteret.
English: Experience administering Pixuvri to patients with more significant cardiac compromise is limited and should only be undertaken in the context of a clinical trial.
Danish: Der er begrænsede erfaringer med administration af Pixuvri til patienter med mere alvorlig hjerteaffektion, og dette bør kun finde sted i forbindelse med et klinisk studie.
English: Pixuvri is a cytotoxic agent.
Danish: Pixuvri er et cytotoksisk middel.
English: Blood counts should be closely monitored when co-administered with agents which inhibit such transporters such as cyclosporine A or tacrolimus, commonly used to control chronic graft-versus-host disease, and the anti-HIV agents ritonavir, saquinavir, or nelfinavir.
Danish: Blodbilledet bør derfor nøje overvåges ved koadministration sammen med midler, der hæmmer sådanne transportproteiner, såsom ciclosporin A og tacrolimus, der er almindeligt anvendt til kontrol af kroniske transplantat-mod-vært-reaktioner, og hiv-midlerne ritonavir, saquinavir og nelfinavir.
English: The recommended dose is 50 mg/m2 of pixantrone on days 1, 8, and 15 of each 28-day cycle for up to
Danish: Den anbefalede dosis er 50 mg/m2 pixantron på dag 1, 8 og 15 af hver 28-dages cyklus i indtil seks cyklusser.
English: Use gloves, masks, and protective eyewear when handling and during decontamination procedures.
Danish: Brug handsker, maske og øjenværn ved håndteringen og ved dekontamineringsprocedurer.
English: Contains sodium, see leaflet for further information.
Danish: Indeholder natrium, de yderligere oplysninger herom fremgår af indlægssedlen.
English: 1-2 LLN* - 50 x 10 9/l LLN - 1.0 x 10 9/l No change in dose or schedule.
Danish: Dosisjustering 1-2 LLN* - 50 x 109/l LLN - 1,0 x 109/l Ingen ændring i dosis eller doseringsplan.
English: Warfarin is partially metabolised by CYP1A2, therefore, a theoretical concern exists with regard to co-administration of this medicinal product and the effect inhibition of its metabolism might have on its intended action.
Danish: Warfarin metaboliseres delvis af CYP1A2, hvorfor man teoretisk kan være betænkelig ved koadministration af dette lægemiddel og den virkning, som hæmning af dets metabolisering kan tænkes at have.
English: Very common: may affect more than 1 in 10 people - nausea, vomiting - skin discolouration - thinning or loss of hair - abnormal colouration of the urine - physical weakness - low number of white blood cells, low number of red blood cells (anaemia), and low number of platelets in the blood (may require transfusion).
Danish: Meget almindelig: kan påvirke flere end 1 ud af 10 personer - kvalme, opkastning - misfarvning af huden - tyndt hår eller hårtab - unormal farve af urinen - fysisk svaghed - lavt antal hvide blodlegemer, lavt antal røde blodlegemer (anæmi) og lavt antal blodplader (kan kræve transfusion).
English: Dose modification guidelines
Danish: Retningslinjer for dosisjustering
English: Pixuvri is for single use only.
Danish: Pixuvri er udelukkende til engangsbrug.
English: Patients on a sodium restricted diet
Danish: Patienter på natriumfattig diæt
English: Although the occurrence of cardiac toxicity manifested by CHF appears to be lower than that would be expected with related medicinal products such as anthracyclines, monitoring of LVEF either by MUGA scans or ECHO is recommended to assess subclinical cardiotoxicity.
Danish: Skønt forekomsten af kardiotoksicitet i form af kongestiv hjerteinsufficiens (CHF) ser ud til at være lavere end forventet for beslægtede lægemidler som antracycliner, anbefales det at overvåge venstre ventrikels uddrivningsfraktion (LVEF) ved MUGA-skanning eller ekkokardiografi for at give mulighed for at vurdere subklinisk kardiotoksicitet.
English: What you need to know before you use Pixuvri
Danish: Det skal du vide, før du begynder at bruge Pixuvri
English: Theophylline levels should be carefully monitored in the weeks immediately following initiation of Pixuvri concurrent therapy.
Danish: Theophyllinniveauet bør overvåges nøje i de første uger efter sideløbende initiering af behandling med Pixuvri.
English: In-use storage conditions
Danish: Opbevaring ved brug
English: The safety and efficacy of Pixuvri as single-agent therapy were evaluated in a multicentre, randomised, active controlled trial in patients with relapsed or refractory aggressive NHL after receiving at least two prior therapies.
Danish: Pixuvris sikkerhed og virkning som monoterapi blev vurderet i et randomiseret, kontrolleret multicenterstudie med aktivt sammenligningspræparat hos patienter, der havde recidiverende eller refraktært aggressivt NHL efter mindst to forudgående behandlinger af anden type (PIX301).
English: Table 1 Dose modifications for hematologic toxicity on days 8 and 15 of any cycle Grade Platelet count
Danish: Tabel 1 Dosisjustering ved hæmatologisk toksicitet på dag 8 og 15 af en vilkårlig cyklus Grad Trombocyttal
English: The other ingredients are lactose monohydrate, sodium hydroxide, hydrochloric acid, and sodium chloride.
Danish: Øvrige indholdsstoffer: laktosemonohydrat, natriumhydroxid, saltsyre og natriumchlorid.
English: Pixuvri is given on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles.
Danish: Hvor ofte Pixuvri gives Pixuvri gives på dag 1, 8 og 15 i hver 28-dages cyklus i indtil seks cyklusser.
English: Patients with cardiac disease or risk factors such as a baseline LVEF value of < 45% by multigated radionuclide (MUGA) scan, clinically significant cardiovascular abnormalities (equal to New York Heart Association [NYHA] grade 3 or 4), myocardial infarction within the last 6 months, severe arrhythmia, uncontrolled hypertension, uncontrolled angina, or prior cumulative doses of doxorubicin or equivalent exceeding 450 mg/m2 should receive careful risk versus benefit consideration before receiving treatment with Pixuvri.
Danish: Der bør foretages en nøje benefit/risk-vurdering, før behandlingen med Pixuvri indledes hos patienter med kardiel sygdom eller risikofaktorer som baseline-LVEF < 45 % ved multigated radionuklidskanning (MUGA), klinisk betydningsfulde kardiovaskulære abnormiteter (svarende til New York Heart Association [NYHA] grad 3 eller 4), myokardieinfarkt inden for de seneste seks måneder, svær arytmi, ukontrolleret hypertension, ukontrolleret angina pectoris eller foregående kumulative doser af doxorubicin på over 450 mg/m2 eller ækvivalente kumulerede doser af andre antracykliner.
English: Pixuvri is for intravenous use only.
Danish: Pixuvri er udelukkende til intravenøs anvendelse.
English: The active substance is pixantrone.
Danish: Aktivt stof: pixantron.
English: Importantly, growth factor support was not routinely required and transfusions with red blood cells and platelets were uncommon.
Danish: Det er vigtigt at bemærke, at det ikke rutinemæssigt var nødvendigt at anvende hæmatopoietiske vækstfaktorer, og det var ikke almindeligt at give transfusioner af erytrocytter og trombocytter.
English: Upon reconstitution and dilution, this medecine contains approximately 1g (43 mmol) sodium (main component of cooking salt) per dose.
Danish: Efter rekonstitution og fortynding indeholder dette lægemiddel 1 g (43 mmol) natrium (hovedkomponent af madlavnings-/bordsalt) pr. dosis.
English: Very common Nausea, vomiting
Danish: Meget almindelig Kvalme, opkastning
English: Tabulated list of adverse reactions Adverse drug reactions (ADR) reported with Pixuvri are from final data from all completed single agent studies (n=197).
Danish: De indberettede bivirkninger (ADR) ved Pixuvri er baseret på endelige data fra alle afsluttede monoterapi-studier (n=197).
English: Pixuvri is given through a drip into a vein (by intravenous infusion).
Danish: Hvordan Pixuvri gives Pixuvri gives med drop i en vene (ved intravenøs infusion).
English: Pixuvri is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas (NHL).
Danish: Pixuvri er indiceret som monoterapi til behandling af voksne patienter med gentagent recidiverende eller behandlingsrefraktære, aggressive B-celle non-Hodgkins lymfomer (NHL).
English: The pharmacokinetics of Pixuvri was dose-independent in the 3 mg/m2 to105 mg/m2 dose range and no substantial differences were observed when the medicinal product was given as a single agent or in combination studies.
Danish: Farmakokinetikken af Pixuvri var dosisuafhængig i området 3 mg/m2 til 105 mg/m2, og var i det væsentlige uafhængig af, om lægemidlet blev givet som monoterapi eller i kombinationsstudier.
English: Delay treatment and monitor until recovery.Consider discontinuation for persistent decline in LVEF** of ≥ 15% of baseline value.
Danish: Overvej seponering ved persisterende fald i LVEF** på ≥ 15 % af udgangsværdien.
English: Tell the person giving you the infusion immediately if you feel pain or if the injection site gets red.
Danish: Hvis injektionen gør ondt eller injektionsstedet bliver rødt, skal du straks sige det til den, der giver dig infusionen.
English: Reconstituted pixantrone solution is stable for up to 24 hours at room temperature (15°C to 25°C) in standard infusion bags.
Danish: Den rekonstituerede opløsning af pixantron er stabil i indtil 24 timer ved rumtemperatur (15 °C til 25 °C) i standard-infusionsposer.
English: Pixantrone was a poor inhibitor of OATP1B1 and OATP1B3 uptake transporters in vitro.
Danish: Pixantron hæmmede kun i ringe grad optagelsestransportørerne OATP1B1 og OATP1B3 in vitro.
English: Pixuvri is not recommended for use in patients with severe excretory hepatic impairment, (see section 4.3).
Danish: Pixuvri anbefales ikke hos patienter med svær ekskretorisk nedsat leverfunktion (se pkt.
English: Common Anorexia, hypophosphataemia Uncommon Hyperuricaemia, hypocalcaemia, hyponatraemia,
Danish: Almindelig Anoreksi, hypofosfatæmi Ikke almindelig Hyperurikæmi, hypokalcæmi, hyponatriæmi
English: Driving and using machines It is not known whether Pixuvri has an effect on your ability to drive a car or use machines.
Danish: Trafik- og arbejdssikkerhed Det vides ikke, om Pixuvri påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: Pixuvri is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Pixuvri bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: In dogs, the heart was not affected by treatment, as no ECG changes were seen at different treatment times, nor heart changes were detected at gross- and histopathology.
Danish: idet der ikke sås EKG-forandringer på forskellige behandlingstidspunkter og ikke fandtes hjerteforandringer ved makroskopisk eller histopatologisk studie.
English: Uncommon Anxiety, insomnia, sleep disorder
Danish: Ikke almindelig Angst, søvnløshed, søvnforstyrrelser
English: Males were more sensitive to treatment, with respect to reduction in white blood cells and platelet count (reversible) and lymphoid depletion (spleen and thymus), as well as the marked toxicity to reproductive organs, as expected from a cytotoxic agent.
Danish: Handyr viste større følsomhed over for behandlingen i form af (reversible) fald i leukocyttal og trombocyttal, lymfoid depletion (milt og thymus) og markant toksisk virkning på reproduktionsorganerne som forventeligt af et cytotoksisk stof.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (15°C to 25°C) and daylight exposure in polyethylene (PE) standard infusion bags.
Danish: Der er påvist kemisk og fysisk stabilitet i brug i løbet af 24 timer ved rumtemperatur (15 °C til 25 °C) og ved udsættelse for dagslys i standardinfusionsposer af polyethylen.
English: Use gloves, masks, and protective eyewear when handling Pixuvri and during decontamination procedures.
Danish: Brug handsker, maske og øjenværn ved håndtering af Pixuvri og ved dekontamineringsprocedurer.
English: Uncommon Chills, injection site coldness, local reaction
Danish: Kulderystelser, kuldefølelse på injektionsstedet, lokalreaktion
English: Pixuvri contains sodium
Danish: Pixuvri indeholder natrium
English: What Pixuvri contains
Danish: Pixuvri indeholder
English: In a colony-forming units study in mice, the myelotoxicity of Pixuvri and mitoxantrone administered at their LD10 (pixantrone dimaleate 38 mg/kg and mitoxantrone 6.1 mg/kg) was similar.
Danish: I et studie af kolonidannende enheder hos mus havde Pixuvri samme myelotoksicitet som mitoxantron ved administration af de to stoffer i en dosis svarende til LD10 (pixantrondimaleat 38 mg/kg og mitoxantron 6,1 mg/kg).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs http://www.ema.europa.eu hjemmeside.
English: The results in the rituximab pretreated patients still showed superior treatment benefit with Pixuvri over the comparator for overall response rate (31.6% with Pixuvri versus 17.9% with the comparator) and median progression-free survival (3.3 months with Pixuvri versus 2.5 months with the comparator).
Danish: For patienter, der tidligere var behandlet med rituximab, viste resultaterne stadig større gavn af behandling med Pixuvri end med komparatorstoffet i form af samlet responsrate (31,6 % med Pixuvri mod 17,9 % i standardarmen) og median progressionsfri overlevelse (3,3 måneder med Pixuvri mod 2,5 måneder i standardarmen).
English: After reconstitution, each ml of concentrate contains pixantrone dimaleate equivalent to 5.8 mg pixantrone.
Danish: Efter rekonstitution indeholder hver ml koncentrat pixantrondimaleat svarende til 5,8 mg pixantron.
English: Common Dyspnoea, cough Uncommon Pleural effusion, pneumonitis, rhinorrhoea
Danish: Almindelig Dyspnø, hoste Ikke almindelig Pleuraeffusion, pneumonitis, rhinorré
English: After reconstitution with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection, each ml of concentrate contains pixantrone dimaleate equivalent to 5.8 mg pixantrone.
Danish: Efter rekonstitution med 5 ml natriumchlorid, 9 mg/ml (0,9 %), injektionsvæske, opløsning, indeholder hver ml koncentrat pixantrondimaleat svarende til 5,8 mg pixantron.
English: - Warfarin to prevent blood clot formation - Theophylline to treat lung conditions like emphysema or asthma - Amitriptyline to treat depression - Olanzapine, Clozapine to treat schizophrenia or maniac depression - Haloperidol to treat anxiety and sleeplessness - Ondansetron to prevent nausea and vomiting during chemotherapy - Propranolol to treat high blood pressure
Danish: - warfarin til forebyggelse af blodpropper - teofyllin til behandling af lungesygdomme som emfysem eller astma - amitriptylin til behandling af depression - olanzapin eller clozapin til behandling af skizofreni eller maniodepressiv sindslidelse - haloperidol til behandling af angst og søvnløshed - ondansetron til behandling af kvalme eller opkastning under kemoterapi - propranolol til behandling af forhøjet blodtryk
English: Modification
Danish: Justering
English: Average exposures as single agent accounted for:
Danish: Den gennemsnitlige eksponering ved monoterapi var:
English: Type I glass vial with grey butyl rubber stopper with aluminium seal and red plastic cap containing 50 mg pixantrone dimaleate equivalent to 29 mg pixantrone.
Danish: Hætteglas (glas type I) med prop af gråt butylgummi, forsegling af aluminium og låg af rød plastic, indeholdende 50 mg pixantrondimaleat svarende til 29 mg pixantron.