FrancophonIA/ELRC3.0 huggingface dataset:
English: • Before you receive MYLOTARG, you will be given some medicines to help reduce symptoms such as fever and chills, known as infusion reactions, during or shortly after the MYLOTARG infusion.
Danish: • Inden du får MYLOTARG, får du medicin, der hjælper med at mindske symptomer såsom feber og kuldegysninger, kaldet infusionsreaktioner, under og kort efter MYLOTARG-infusionen.
English: The overall safety profile of MYLOTARG is based on data from patients with acute myeloid leukaemia from the combination therapy study ALFA-0701, monotherapy studies, and from post-marketing experience.
Danish: MYLOTARGs sikkerhedsprofil er baseret på data fra patienter med akut myeloid leukæmi fra studiet ALFA-0701 med kombinationsbehandling, monoterapistudier og fra indberetninger efter markedsføring.
English: Given that the hP67.6 portion renders target selectivity on the intact molecule, and that gemtuzumab ozogamicin dosages are reported in terms of milligrams of protein (hP67.6), the hP67.6 concentration results are reported as the primary PK measures.
Danish: Eftersom hP67.6-delen giver målselektivitet på det intakte molekyle, og gemtuzumab ozogamicin doser bliver rapporteret som milligram protein (hP67.6), bliver resultaterne af hp67,6-koncentrationen rapporteret som de primære PK-målinger.
English: Gemtuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody which specifically recognises human CD33.
Danish: Gemzumab er et humaniseret immunoglobulin, klasse G, undergruppe 4 (IgG4) antistof, der specifikt genkender humant CD33.
English: No clinical drug interaction studies have been conducted with MYLOTARG.
Danish: Der er ikke udført kliniske interaktionsstudier med MYLOTARG.
English: What you need to know before you are given MYLOTARG
Danish: Det skal du vide, før du får MYLOTARG
English: • A doctor or nurse will give you MYLOTARG through a drip in your vein (intravenous infusion [IV]) gradually over 2 hours.
Danish: • En læge eller sygeplejerske giver dig MYLOTARG via et drop i en blodåre (intravenøs infusion (i.v.).
English: In 23.5% of the studies the majority of patients received fractionated (3 mg/m2 on Day 1, 4, 7) doses of MYLOTARG, while in 35.3% of the studies doses higher than 3 mg/m2 were given.
Danish: I 23,5 % af studierne fik størstedelen af patienterne fraktionerede (3 mg/m2 på dag 1, 4 og 7) doser af MYLOTARG, mens der i 35,3 % af studierne blev givet doser over 3 mg/m2.
English: Discard any unused reconstituted solution left in the vial.
Danish: Eventuelt ubrugt, resterende rekonstitueret opløsning i hætteglasset skal kasseres.
English: Additional findings included effects on the testes, epididymides and mammary gland as well as fertility.
Danish: Yderligere fund omfattede påvirkning af testikler, bitestikler og brystkirtler samt fertilitet.
English: Although the total dose of the fractionated dosing regimen is half of that of the original dosing regimen (9 versus 18 mg/m2), the predicted total AUC of hP67.6 over the course of treatment is 25%, and Cmax is 24%, of the values for original 9 mg/m2 dosing regimen, since the PK is nonlinear.
Danish: Skønt den samlede dosis for den fraktionerede doseringsplan udgør halvdelen af det oprindelige doseringsplan (9 versus 18 mg/m2), er den forudsete samlede AUC for hP67.6 under behandlingsforløbet 25 % og Cmax 24 % af værdierne for det oprindelige 9 mg/m2 doseringsplan, siden PK er ikke-lineær.
English: Complications associated with neutropenia and thrombocytopenia may include infections and bleeding/haemorrhagic reactions respectively.
Danish: Komplikationer forbundet med neutropeni og trombocytopeni kan omfatte henholdsvis infektioner og blødning/hæmoragiske reaktioner.
English: Tables 3 and 4 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
Danish: Skema 3 og Skema 4 viser retningslinjer for dosisjustering ved hhv. hæmatologisk og ikkehæmatologisk toksicitet.
English: c. 2-sided p-value from the log-rank test.
Danish: 2-sided p-værdi fra log-rank test.
English: Dosing regimens for MYLOTARG in combination with chemotherapy
Danish: Doseringsregimer for MYLOTARG kombineret med kemoterapi Behandlingsforløb
English: In the combination therapy study (N=131), VOD was reported in 6 (4.6%) patients during or following treatment, 2 (1.5%) of these reactions were fatal (see Table 5).
Danish: I kombinationsbehandlingsstudiet (N=131) blev VOD rapporteret hos 6 (4,6 %) af patienterne under eller efter behandling, af disse reaktioner var 2 (1,5 %) dødelige (se Skema 5).
English: If AraC is used for leukoreduction with or without hydroxyurea in patients with previously untreated, de novo hyperleukocytic AML receiving MYLOTARG in combination therapy, apply the following modified schedule (Table 2):
Danish: Hvis AraC anvendes til leukoreduktion med eller uden hydroxyurea hos tidligere ubehandlede patienter med de novo hyperleukocytisk AML, der får MYLOTARG i kombinationsbehandling, anvendes følgende modificerede plan (Skema 2):
English: MYLOTARG contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis.
English: Fatal reports of TLS complicated by acute renal failure have been reported in the post-marketing setting.
Danish: Der er blevet rapporteret tilfælde af død i forbindelse med TLS kompliceret med akut nyresvigt efter markedsføring.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglassets etiket og æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Patients should be monitored until signs and symptoms completely resolve and infusion may resume.
Danish: Patienten bør overvåges, indtil symptomerne er fuldstændigt forsvundet, derefter kan infusionen fortsættes.
English: • MYLOTARG contains no bacteriostatic preservatives.
Danish: • MYLOTARG indeholder ikke bakteriehæmmende konserveringsmidler.
English: Gamma-glutamyltransferase increased Uncommon
Danish: Unormal leverfunktion Forhøjet gamma-glutamyltransferase Ikke almindelig
English: • Doses administered by syringe must utilize small bore infusion lines (microbore) with an in-line, low protein-binding 0.2 micron polyethersulphone (PES) filter.
Danish: • Doser indgivet med sprøjte skal bruge infusionsslanger med lille diameter (microbore) med inline lavt protein-bindende 0,2 mikron polyethersulfon (PES)-filter.
English: The antibody portion binds specifically to the CD33 antigen, a sialic acid-dependent adhesion protein found on the surface of myeloid leukaemic blasts and immature normal cells of myelomonocytic lineage, but not on normal haematopoietic stem cells.
Danish: Antistofdelen binder specifikt til antigenet CD33, et sialinsyreafhængigt adhæsionsprotein fundet på overfladen af myeloid leukæmiske blaster og umodne normale celler af myelomonocytisk afstamning, men ikke på normale hæmatopoietiske stamceller.
English: Dose modifications for non-haematological toxicities Non-haematological toxicities Dose modifications VOD/SOS
Danish: Dosisændringer ved ikke-hæmatologisk toksicitet Ikke-hæmatologisk toksicitet Dosisjusteringer VOD/SOS
English: Gemtuzumab ozogamicin was found to be clastogenic.
Danish: Gemtuzumab ozogamicin har vist sig at være klastogent.
English: Persistent neutropenia
Danish: Vedvarende neutropeni
English: • Following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, MYLOTARG solution should be infused immediately.
Danish: • Efter fortynding med natriumchloridopløsning injektionsvæske 9 mg/ml (0,9%) skal MYLOTARG opløsningen straks infunderes.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1277/001
Danish: EU/1/18/1277/001
English: b: Fractionated dosing refers to MYLOTARG dose of 3 mg/m2 on days 1, 4, 7.
Danish: b: Fraktioneret dosering henviser til dosering af MYLOTARG 3 mg/m2 på dag 1, 4 og 7.
English: Formal carcinogenicity studies have not been conducted with gemtuzumab ozogamicin.
Danish: Der er ikke udført formelle karcinogenicitetsstudier med gemtuzumab ozogamicin.
English: Store in a refrigerator (2°C-8°C).
Danish: Opbevares i køleskab (2 C - 8 °C).
English: With MYLOTARG monotherapy, the response rate (CR/CRp/CRi; weighted average across studies) was 33.3% with fractionated dosing (1 study) and 24.3% with non-fractionated dosing (9 studies).
Danish: Med MYLOTARG-monoterapi var responsraten (CR/CRp/CRi; vægtet gennemsnit på tværs af studier) 33,3 % med fraktioneret dosering (1 studie) og 24,3 med ikke-fraktioneret dosering (9 studier).
English: Hepatotoxicity, including hepatic venoocclusive disease/sinusoidal obstruction syndrome (VOD/SOS)
Danish: Levertoksicitet, herunder hepatisk veno-okklusiv sygdom/sinusoidalt obstruktionssyndrom (VOD/SOS)
English: When gemtuzumab ozogamicin is administered at 3 mg/m2 on Days 1, 4, and 7, the Cmax of hP67.6, which would occur at the end of infusion, is predicted to be 0.38 mg/L following the first dose and increased to 0.63 mg/L after the third dose.
Danish: Når gemtuzumab ozogamicin administreres med 3 mg/m2 på dag 1, 4, og 7, er det forudset, at Cmax for hP67.6, der ville fremkomme i slutningen af infusionen, bliver 0,38 mg/l efter den første dosis og forhøjet til 0,63 mg/l efter den tredje dosis.
English: There have been reports of fatal infusion reactions in the post-marketing setting.
Danish: Der er set dødelige infusionsreaktioner efter markedsføring.
English: Only DNR and AraC should be administered during the second induction cycle, at the following recommended dosing: DNR 35 mg/m2/day on Days 1 and 2, and AraC 1 g/m2 every 12 hours, on Day 1 to Day 3.
Danish: Der må kun administreres DNR og AraC under den anden induktionscyklus ved den følgende anbefalede dosering: DNR 35 mg/m2/dag på dag 1 og 2 og AraC 1 g/m2 hver 12. time på dag 1 til dag 3.
English: Abbreviations: C=cytarabine; D=daunorubicin; GO=gemtuzumab ozogamicin; mITT=modified intent-to-treat.
Danish: Forkortelser: C = cytarabin; D = daunorubicin; GO = gemtuzumab ozogamicin; mITT= modifieceret intent-totreat.
English: Non-fractionated dosing refers to MYLOTARG (total dose ranging 1.8 mg/m2 - 9 mg/m2) 2 times during a cycle at least 14 days apart.
Danish: Ikke-fraktioneret dosering henviser til MYLOTARG (interval for total dosis 1,8 mg/m 2 - 9 mg/m 2) 2 gange i løbet af en cyklus med mindst 14 dages mellemrum.
English: Store in the original carton to protect from light.
Danish: Opbevares i den oprindelige æske for at beskytte mod lys.
English: Fatal severe infection was reported in 2 (1.53%) patients in the MYLOTARG arm and 4 (2.92%) patients in the control arm.
Danish: Alvorlig infektion, som førte til dødsfald, blev indberettet for 2 (1,53 %) patienter i MYLOTARG-armen og 4 (2,92 %) patienter i kontrolarmen.
English: In patients, unconjugated calicheamicin plasma levels were typically low, with a predicted mean Cmax of 1.5 ng/mL following the third dose.
Danish: Hos patienterne var det ukonjugerede plasmaniveau for calicheamicin typisk lavt med et forventet gennemsnits Cmax på 1,5 mg/m efter den tredje dosis.
English: Additional characterisation of hepatotoxicity adverse reactions is provided from the monotherapy studies.
Danish: Yderligere karakterisering af levertoksiske bivirkninger fremgår af monoterapistudierne.
English: Overall response % [95% CI]e CR
Danish: Samlet respons % [95 % CI] CR
English: In a male fertility study, effects on male reproduction included lower spermatogonia and spermatocytes, decreases in testicular spermatids and epididymal sperm, vacuolation of the nucleus in spermatids, and/or appearance of giant cells.
Danish: I et fertilitetsstudie var virkningen på hanlig reproduktion færre spermatogonier og spermatocytter, fald i testikulære spermatider og epididymiske sædceller, vakuolisering af cellekernen i spermatider og/eller udvikling af kæmpeceller.
English: 4 studies; N per study (range) 12-84; 42.2%
Danish: 5 studier; N per studie (interval) 12-30; 28,4 % 4 studier; N per studie (interval) 12-84; 42,2 %
English: q. Transaminases increased includes the following reported PTs: Transaminases increased, Hepatocellular injury, Alanine aminotransferase increased, Aspartate aminotransferase increased, and Hepatic enzyme increased.
Danish: Forhøjede transaminaser omfatter følgende indberettede FT'er: transaminaser forøget, hepatocellulær skade, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase og forhøjet hepatisk enzym.
English: The diluted solution can be refrigerated at 2°C-8°C for up to 12 hours.
Danish: Den fortyndede opløsning kan opbevares ved 2°C-8°C I op til 12 timer.
English: The safety and efficacy of MYLOTARG in patients less than 15 years of age has not been established.
Danish: MYLOTARGs sikkerhed og virkning hos patienter, der er under 15 år, er ikke klarlagt.
English: In the combination therapy study, safety data consisting of selected treatment emergent adverse events (TEAEs) considered most important for understanding the safety profile of MYLOTARG consisted of all grades haemorrhages, all grades VOD, and severe infections.
Danish: Efterfølgende blev der indsamlet data fra kombinationsbehandlingsstudiet af udvalgte behandlingsfremkaldte bivirkninger (TEAE'er), som betragtes som de vigtigste for forståelsen af MYLOTARGs sikkerhedsprofil, disse var alle grader af blødninger, alle grader af VOD samt alvorlige infektioner.
English: v. Erythema includes the following reported PTs: Catheter site erythema, Erythema and Infusion site erythema#.
Danish: Erytem omfatter følgende indberettede FT'er: erytem ved katetersted, erytem og erytem på infusionssted w.
English: • Reduced number of red blood cells (anaemia) which may result in fatigue and shortness of breath
Danish: • Nedsat antal røde blodlegemer (blodmangel), hvilket kan medføre træthed og åndenød
English: Based on Population PK analyses, the predicted clearance (CL) value of hP67.6 from plasma was 3 L/h immediately after the first dose and then 0.3 L/h.
Danish: Baseret på PK-populationsanalyser er den forventede clearance (CL)-værdi for hP67.6 fra plasma 3 l/t lige efter den første dosis og 0,3 l/t efter den tredje dosis.
English: Patients should be advised they may experience fatigue, dizziness and headache during treatment with MYLOTARG (see section 4.8).
Danish: Patienterne bør underrettes om, at de kan opleve træthed, svimmelhed og hovedpine under behandling med MYLOTARG (se pkt.
English: However, the optimal dose of gemtuzumab ozogamicin for paediatric patients was not established, since in Study AAML0531 during the second intensification period after the second dose of gemtuzumab ozogamicin, a larger proportion of patients in the gemtuzumab ozogamicin arm experienced prolonged neutrophil recovery time (> 59 days) as compared with the comparator arm (21.0% versus 11.5%), and more patients died during remission (5.5% versus 2.8%).
Danish: Den optimale dosis gemtuzumab ozogamicin til pædiatriske patienter blev dog ikke klarlagt, da der i studiet AAML0531 i den anden intensiveringsperiode efter den anden dosis gemtuzumab ozogamicin, var en større andel af patienter i gemtuzumab ozogamicin-armen, der oplevede forlænget neutrofilrestitutionstid (>59 dage) sammenlignet med komparator-armen (21,0 % vs 11,5 %), og flere patienter døde under remission (5,5 % vs 2,8 %).
English: Selected** adverse reactions in patients who received MYLOTARG in combination therapy study (ALFA-0701)
Danish: Udvalgte bivirkninger hos patienter, der fik MYLOTARG i kombinationsbehandlingsstudiet (ALFA-0701)
English: MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see sections 4.4 and 5.1).
Danish: MYLOTARG er indiceret til kombinationsbehandling med daunorubicin (DNR) og cytarabin (AraC) til behandling af patienter på 15 år og derover med tidligere ubehandlet de novo CD33-positiv akut myeloid leukæmi (AML), bortset fra akut promyelocyt leukæmi (APL) (se pkt.
English: • Bleeding (signs of a low number of blood cells known as platelets) Tell your doctor right away if you bruise easily or get nose bleeds on a regular basis, or have black tarry stools, coughing up of blood, bloody sputum, or change in your mental status.
Danish: • Blødning (tegn på lavt antal blodlegemer kaldet blodplader) Fortæl straks din læge, hvis du let får blå mærker eller tilbagevendende næseblod, eller hvis du har sort, tjæreagtig afføring, hoster blod op, har blodigt spyt eller oplever mental forandring.
English: • Infuse the diluted solution for 2 hours.
Danish: • Den fortyndede opløsning indgives i 2 timer.
English: The analysis included 405 patients in the following NCI ODWG impairment status categories: mild (B1, n=58 and B2, n=19), moderate (C, n=6), and normal hepatic function (n=322) (see section 4.2).
Danish: Analyserne omfattede 405 patienter i følgende NCI ODWG-kategorier over funktionsnedsættelse: let (B1, n=58 og B2, n=19), moderat (C, n=6) og normal leverfunktion (n=322) (se pkt.
English: In clinical studies of MYLOTARG in patients with relapsed or refractory AML, the immunogenicity of MYLOTARG was evaluated using 2 enzyme-linked immunosorbent assays (ELISAs).
Danish: I kliniske studier med MYLOTARG hos patienter med recidiverende eller refraktær AML blev immunogeniciteten for MYLOTARG evalueret ved hjælp af to ELISA test (Enzyme Linked Immuno Sorbent Assay).
English: N-acetyl gamma calicheamicin DMH (the released cytotoxin) was found to be mutagenic and clastogenic.
Danish: N-acetyl-gamma-calicheamicin DMH (det frigivne cytotoksin) viste sig at være mutagent og klastogent.
English: • It is recommended that the infusion container be made of polyvinyl chloride (PVC) with DEHP, or polyolefin (polypropylene and/or polyethylene).
Danish: • Det anbefales at bruge en infusionsbeholder fremstillet af PVC med DEHP eller polyolefin (polypropylen og/eller polyætylen).
English: Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Danish: Aktivering af Nacetyl-gamma-calicheamicin dimethylhydrazid inducerer brud på dobbeltstrenget DNA, hvorefter der induceres standsning af cellecyklus og apoptotisk celledød.
English: The incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, circulating gemtuzumab ozogamicin concentrations, sample handling, timing of sample collection, concomitant treatments and underlying disease.
Danish: Forekomsten af antistofpositivitet i en analyse kan påvirkes af flere faktorer, herunder analysemetode, koncentrationen af cirkulerende gemtuzumab ozogamcin, prøvehåndtering, tidspunkt for prøvetagning, samtidig medicinering og underliggende sygdom.
English: If a second induction is required, MYLOTARG should not be administered during second induction therapy.
Danish: Hvis der kræves endnu en induktion, må MYLOTARG ikke administreres under denne induktionsbehandling.
English: The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic semisynthetic natural product.
Danish: Det lille molekyle, N-acetyl-gamma-calicheamicin, er et cytotoksisk semisyntetisk naturligt stof.
English: In the combination therapy study ALFA-0701, clinically relevant serious adverse reactions were hepatotoxicity, including VOD/SOS (3.8%), haemorrhage (9.9%), severe infection (41.2%), and tumour lysis syndrome (1.5%).
Danish: I kombinationsbehandlingsstudiet ALFA-0701 var de klinisk relevante alvorlige bivirkninger levertoksicitet, herunder VOD/SOS (3,8 %), blødning (9,9 %), alvorlig infektion (41,2 %) og tumorlysesyndrom (1,5 %).
English: • High level of uric acid in the blood
Danish: • Forhøjet mængde urinsyre i blodet.
English: No cases of overdose with MYLOTARG were reported in clinical experience.
Danish: Der er ikke indberettet tilfælde af Mylotarg overdosering fra klinisk praksis.
English: In total, 271 patients were randomised in this study with 135 to induction treatment of 3+7 DA plus fractionated 3 mg/m2 × 3 doses of MYLOTARG and 136 to 3+7 DA alone (see section 4.2).
Danish: I alt blev 271 patienter randomiseret i dette studie med 135 til induktionsbehandling af 3+7 DA plus fraktioneret 3 mg/m x 3 doser MYLOTARG og 136 til 3+7 DA alene (se pkt.
English: • Oedema (excess fluid in body tissue, causing swelling of the hands and feet)
Danish: • Ødem (for meget væske i kroppen, fx hævelse af hænder og fødder)
English: fungal lung infections including Pulmonary mycosis and Pneumocystis jirovecii pneumonia*; and bacterial infections including Stenotrophomonas infection were also reported.
Danish: Efter markedsføring er der også indberettet (hyppighed ikke kendt) svampinfektioner i lungerne, herunder lungemykose og pneumocystosis jirovicii* samt bakterieinfektioner, herunder stenotrophomonasinfektion.
English: The most common adverse reactions (> 30%) in the combination therapy study were haemorrhage and infection.
Danish: De mest almindelige bivirkninger (>30 %) i studiet med kombinationsbehandling var blødning og infektion.
English: The results of the population modelling showed that the PK behaviour of gemtuzumab ozogamicin (hP67.6 antibody and unconjugated calicheamicin) is similar between adult and paediatric AML patients following the 9 mg/m2 dosing regimen.
Danish: Resultaterne fra populationsmodellering viste, at gemtuzumab ozogamicins (hP67.6 antistof og ukonjugeret calicheamicin) PK-reaktion er den samme hos voksne og pædiatriske AML-patienter, som følger doseringsregimenet 9 mg/m
English: No adjustment of the starting dose is required in patients with hepatic impairment defined by total bilirubin ≤ 2 × upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT)
Danish: Anvendelse hos patienter med nedsat leverfunktion Det er ikke nødvendigt at justere startdosis til patienter med nedsat leverfunktion, defineret som total bilirubin ≤ 2 × den øvre normalgrænse (ULN) og aspartataminotransferase (ASAT)/alaninaminotransferase (ALAT) ≤ 2,5 × ULN.
English: Dose and schedule modifications
Danish: Ændringer af dosis og behandlingsplan
English: However, it was also found that increased toxicity (post-remission toxic mortality) was observed in patients with low-risk AML which was attributed to the prolonged neutropenia that occurred after receiving gemtuzumab ozogamicin during intensification Course 2 (see sections 4.2 and 4.8).
Danish: Det blev dog også konstateret, at der sås forhøjet toksicitet (post-remission toksisk dødelighed) hos patienter med lavrisiko AML, hvilket blev henført til den længerevarende neutropeni, som opstod efter at have fået gemtuzumab ozogamicin under intensiveringsforløb 2 (se pkt.
English: MYLOTARG does not undergo renal clearance, the pharmacokinetics in patients with severe renal impairment is unknown (see section 5.2).
Danish: MYLOTARG undergår ikke renal udskillelse, og farmakokinetikken hos patienter med alvorligt nedsat nyrefunktion er ukendt (se pkt.
English: Non-clinical data suggest that the anticancer activity of gemtuzumab ozogamicin is due to the binding of the ADC to CD33-expressing tumour cells, followed by internalisation of the ADC-CD33 complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker.
Danish: Non-kliniske data tyder på, at gemtuzumab ozogamicins aktivitet mod cancer skyldes bindingen af ADC til tumorceller, der udtrykker CD33, efterfulgt af internalisering af ADC-CD33-komplekset og den intracellulære frigivelse af N-acetylgamma-calicheamicin dimethylhydrazid via hydrolytisk spaltning af bindingen.
English: daunorubicin cytarabine
Danish: daunorubicin cytarabin
English: Schedule modification for the treatment of hyperleukocytosis with cytarabine
Danish: Ændret plan for behandling af hyperleukocytose med cytarabin Behandling sforløb
English: • Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)
Danish: • Gulfarvning af huden eller det hvide i øjnene forårsaget af problemer i levereren eller blodet