FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequent Grade 3 bleeding/haemorrhagic reactions were epistaxis (1.5%), haemoptysis (3.1%), and haematuria (2.3%).
Danish: De hyppigste grad 3 blødning/hæmoragiske reaktioner var epistaxis (1,5 %), hæmoptyse (3,1 %) og hæmaturi (2,3 %).
English: w. Pyrexia includes the following reported PTs: Pyrexia, Body temperature increased, and Hyperthermia.
Danish: Pyreksi omfatter følgende indberettede FT'er: pyreksi, forhøjet kropstemperatur og hypertermi.
English: Several single agent studies measured target (CD33) saturation post-MYLOTARG dose in patients with relapsed and refractory AML.
Danish: Adskillige enkeltstof-studier målte CD33-mætning efter MYLOTARG dosering hos patienter med recidiveret og refraktær AML.
English: a. Median estimated by Kaplan-Meier method; CI based on the Brookmeyer-Crowley method with log-log transformation.
Danish: Median estimeret ud fra Kaplan-Meier kurven; CI baseret på Brookmeyer-Crowley metoden med log-log transformation.
English: The efficacy of MYLOTARG has been shown in AML patients with favourable- and intermediate-risk cytogenetics, with uncertainty regarding the size of the effect in patients with adverse cytogenetics (see section 5.1).
Danish: Virkningen af MYLOTARG er vist hos AML-patienter med god- eller intermediær risiko-cytogenetik, med usikkerhed omkring graden af effekt hos patienter med ugunstig risiko-cytogenetik (se pkt.
English: The safety and efficacy of MYLOTARG in children and adolescents with previously untreated AML below the age of 15 years has not been established (see section 4.2).
Danish: MYLOTARGs sikkerhed og virkning hos børn og unge under 15 år med tidligere ubehandlet AML er ikke klarlagt (se pkt.
English: Tell your doctor right away if you have rapid weight gain, feel pain in the upper right side of your abdomen, have accumulation of fluid causing abdominal swelling.
Danish: Du bør straks fortælle din læge, hvis du oplever brat vægtøgning, smerter i øverste højre side af maven, ophobning af væske, der resulterer i en opsvulmet mave.
English: In vitro studies demonstrated that N-acetyl gamma calicheamicin dimethyl hydrazide is extensively metabolised, primarily via nonenzymatic reduction of the disulphide moiety.
Danish: In vitro-studier har påvist, at N-acetyl-gammacalicheamicin dimethylhydrazid bliver metaboliseret i stor udstrækning, primært via non-enzymatisk reduktion af disulfiddelen.
English: daunorubicin + cytarabine (N=137)
Danish: daunorubicin + cytarabin (N=137)
English: In the combination therapy study (N=131), all grades and Grade 3/4 bleeding/haemorrhagic reactions were reported in 118 (90.1%) and 27 (20.6%) patients, respectively.
Danish: Under kombinationsbehandlingsstudiet (N=131) blev der indberettet alle grader og grad 3/4 blødning/hæmoragiske reaktioner hos henholdsvis 118 (90,1 %) og 27 (20,6 %) patienter.
English: The primary metabolic pathway of gemtuzumab ozogamicin is anticipated to be hydrolytic release of N acetyl gamma calicheamicin dimethyl hydrazide.
Danish: Den primære metaboliske vej for gemtuzumab ozogamicin forventes at være hydrolytisk frigivelse af N-acetyl-gamma-calicheamicin dimethylhydrazid.
English: 28.0 [16.3, NE]
Danish: 28,0 (16,3 - ikke estimerbart)
English: • Abnormal liver function
Danish: • Unormal leverfunktion
English: Patients should be monitored for hepatotoxicity as recommended in section 4.4.
Danish: Patienterne bør monitoreres for levertoksicitet som anbefalet i pkt.
English: It is supplied as white to off-white cake or powder.
Danish: Det leveres som en hvid/råhvid substans eller pulver.
English: • Inflammation of the urinary bladder resulting in bleeding from the bladder
Danish: • Betændelseslignende tilstand i urinblæren, der resulterer i blødning fra blæren.
English: • Inflammation of the bowel in association with low white blood cell counts
Danish: • Betændelseslignende tilstand i tarmene i forbindelse med et lavt antal hvide blodlegemer
English: Dose modifications
Danish: Dosisændringer
English: White to off-white cake or powder.
Danish: Hvid til råhvid substans eller pulver.
English: Therefore, coadministration of gemtuzumab ozogamicin with inhibitors or inducers of cytochrome P450 (CYP) or uridine diphosphate glucuronosyltransferase (UGT) drug metabolising enzymes are unlikely to alter exposure to N-acetyl gamma calicheamicin dimethyl hydrazide.
Danish: Derfor vil samtidig administration af gemtuzumab ozogamicin og hæmmere eller fremkaldere af cytokrom P450 (CYP) eller uridindifosfatglucuronosyltransferase (UGT) sandsynligvis ikke ændre eksponeringen for N-acetyl-gamma-calicheamicin-dimethylhydrazid.
English: Increased embryolethality and foetal morphological anomalies included digital malformations, absence of the aortic arch, anomalies in the long bones in the forelimbs, misshapen scapula, absence of a vertebral centrum, and fused sternebrae.
Danish: Forøget embryomortalitet og føtal morfologiske anomalier omfattede digitale misdannelser (ektrodaktyli/brakydaktyli), fravær af aortabue, anomalier i forbenenes lange knogler, misdannet skulderblad, fravær af vertebralt centrum og sammenvokset brystben.
English: After gemtuzumab ozogamicin binds to the target it is internalised and N-acetyl calicheamicin is released by hydrolytic cleavage.
Danish: Når gemtuzumab ozogamicin binder til målet, bliver det internaliseret, og N-acetyl-calicheamicin frigives ved hydrolytisk fraspaltning.
English: MYLOTARG has not been studied in patients with severe renal impairment.
Danish: MYLOTARG har ikke været undersøgt hos patienter med alvorligt nedsat nyrefunktion.
English: In an embryo-foetal toxicity study lower foetal body weight, higher incidence of foetal wavy ribs, and lower incidence of foetal skeletal ossification were observed.
Danish: I et embryo-føtalt toksicitetsstudie blev der observeret nedsat fostervægt, højere forekomst af føtal bølgede ribben og nedsat føtal knogledannelse.
English: Efficacy results from study ALFA-0701 (mITT population)
Danish: Resultater fra ALFA-0701-studiet (mITT population)
English: Based on a population PK analysis, the clearance of gemtuzumab ozogamicin (hP67.6 antibody and unconjugated calicheamicin) is not expected to be affected by mild hepatic impairment status, as defined by National Cancer Institute Organ Dysfunction Working Group (NCI ODWG).
Danish: Baseret på en farmakokinetisk populationsanalyse forventes det ikke, at clearance af gemtuzumab ozogamicin (hP67.6 antistof og ukonjugeret calicheamicin) påvirkes ved let nedsat leverfunktion, som defineret af National Cancer Institute Organ Dysfunction Working Group (NCI ODWG).
English: Withdraw this amount from the vial using a syringe.
Danish: Træk denne mængde op af hætteglasset vha. en sprøjte.
English: N-acetyl gamma calicheamicin is covalently attached to the antibody via an AcBut (4-(4-acetylphenoxy) butanoic acid) linker.
Danish: N-acetyl-gamma-calicheamicin er kovalent bundet til antistoffet via en AcBut (4-(4-acetylfenolat) smørsyre)-binding.
English: • The active substance is gemtuzumab ozogamicin.
Danish: • Aktivt stof/aktive stoffer: gemtuzumab ozogamicin.
English: Abbreviations: AML=acute myeloid leukaemia; AraC=cytarabine; BMA=bone marrow aspirate, DNR=daunorubicin.
Danish: Forkortelser: AML = akut myeloid leukæmi; AraC = cytarabin; BMA = knoglemarvsaspirat, DNR = daunorubicin.
English: Event-free survival (by Investigator)
Danish: Hændelsesfri overlevelse (ved investigator)
English: Based on a population PK analysis, age, race, and gender did not significantly affect gemtuzumab ozogamicin disposition.
Danish: Baseret på en farmakokinetisk populationsanalyse påvirker alder, race eller køn ikke omsætningen af gemtuzumab ozogamicins i væsentlig grad.
English: • If neutrophil count does not recover to greater than 500/mm3 within 14 days following the planned start date of the consolidation cycle (14 days after haematologic recovery following previous cycle), discontinue MYLOTARG (do not administer MYLOTARG in the consolidation cycles).
Danish: 14 dage efter konsolideringsforløbets planlagte startdato (14 dage efter hæmatologisk restituering efter forgående cyklus), skal MYLOTARG seponeres (administrer ikke MYLOTARG i konsolideringscyklussen).
English: • If platelet count recovery remains < 50,000/mm3 for greater than 14 days consolidation therapy should be re-evaluated and a BMA should be performed to re-assess the patients' status.
Danish: 3 i mere end 14 dage, bør konsolideringsbehandling genovervejes, og der bør udføres BMA for at genvurdere patientens status.
English: Because of the potential for adverse reactions in breast-fed children, women should not breast-feed during treatment with MYLOTARG and for at least 1 month after the final dose (see section 5.3).
Danish: På grund af den potentielle risiko for bivirkninger hos ammede spædbørn må kvinder ikke amme under behandling med MYLOTARG og i mindst én måned efter sidste dosis (se pkt.
English: Premedication with a corticosteroid, antihistamine, and acetaminophen (or paracetamol) is recommended 1 hour prior to dosing to help ameliorate infusion-related symptoms (see section 4.4).
Danish: Det anbefales at præmedicinere med et kortikosteroid, antihistamin og acetaminofen (eller paracetamol) 1 time inden dosering med henblik på at afhjælpe infusionsrelaterede symptomer (se pkt.
English: In the combination therapy study in patients with previously untreated de novo AML treated with fractionated doses of gemtuzumab ozogamicin in combination with chemotherapy, Grade 3/4 decreases in leukocytes, neutrophils, and platelets were observed in 131 (100%), 124 (96.1%), and 131 (100%) patients, respectively.
Danish: I kombinationsbehandlingsstudiet hos patienter med tidligere ubehandlet de novo AML behandlet med fraktionerede doser gemtuzumab ozogamicin kombineret med kemoterapi, blev der observeret nedsat antal leukocytter, neutrofile og trombocytter af grad 3/4 hos henholdsvis 131 (100 %), 124 (96,1 %) og 131 (100 %) patienter.
English: Premedication with a corticosteroid, antihistamine and acetaminophen (or paracetamol) is recommended 1 hour prior to MYLOTARG dosing (see section 4.2).
Danish: Det anbefales at præmedicinere med kortikosteroid, antihistamin og acetaminofen (eller paracetamol) 1 time inden dosering af MYLOTARG (se pkt.
English: • The other ingredients are dextran 40, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous.
Danish: • Øvrige indholdsstoffer: dextran 40, saccharose, natriumchlorid, natriumdihydrogenphosfatmonohydrat, vandfri dinatriumphosfat.
English: The recommended dose of MYLOTARG is 3 mg/m2/dose (up to a maximum of one 5 mg vial) infused over a 2-hour period on Days 1, 4, and 7 in combination with DNR 60 mg/m2/day infused over 30 minutes on Day 1 to Day 3, and AraC 200 mg/m2/day by continuous infusion on Day 1 to Day 7.
Danish: Den anbefalede dosis MYLOTARG er 3 mg/m2/dosis (op til højst et hætteglas a 5 mg) infunderet over en 2-timers periode på dag 1, 4 og 7 i kombination med DNR 60/m2/dag indgivet over 30 minutter på dag 1 til dag 3 samt AraC 200 mg/m 2/dag ved kontinuerlig infusion på dag 1 til dag 7.
English: Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; SOS=sinusoidal obstruction syndrome; ULN=upper limit of normal; VOD=venoocclusive disease.
Danish: Forkortelser: ALAT = alaninaminotransferase; ASAT = aspartataminotransferase; SOS = sinusoidalt obstruktionssyndrom; ULN = øvre normalgrænse; VOD = veno-okklusiv sygdom.
English: Safety results observed in a systematic literature review of studies evaluating MYLOTARG in paediatric patients (see section 5.1), are presented in Table 7.
Danish: De sikkerhedsresultater, der blev observeret i en systematisk litteraturgennemgang af studier til evaluering af MYLOTARG hos pædiatriske patienter (se pkt.
English: Respiratory, thoracic and mediastinal disorders Very common Dyspnoean
Danish: Luftveje, thorax og mediastinum Meget almindelig Dyspnø
English: ***MYLOTARG in the treatment of relapsed AML (9 mg/m2).
Danish: MYLOTARG i behandling af tilbagefald af AML (9 mg/m Enkelttilfælde.
English: o Doses greater than or equal to 3.9 mg are to be diluted in a syringe or an IV bag in an appropriate volume of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure a final concentration between 0.075 mg/mL to 0.234 mg/mL.
Danish: o Doser større end eller lig med 3,9 mg skal fortyndes i en sprøjte eller en infusionspose i et passende volumen natriumchlorid 9 mg/ml (0,9%) opløsning til indsprøjtning for at sikre en færdig koncentration på mellem 0,075 mg/ml og 0,234 mg/ml.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan forekomme hos 1 ud af 10 personer):
English: n. Dyspnoea includes the following reported PTs: Dyspnoea and Dyspnoea exertional.
Danish: Dyspnø omfatter følgende indberettede FT'er: dyspnø og funktionsdyspnø.
English: See Table 1 for dose recommendations for consolidation course.
Danish: dosisanbefalinger for konsolideringsforløbet.
English: In monotherapy studies, clinically relevant serious adverse reactions also included infusion related reactions (2.5%), thrombocytopenia (21.7%), and neutropenia (34.3%).
Danish: I monobehandlingsstudierne omfattede de klinisk relevante alvorlige bivirkninger også infusionsrelaterede reaktioner (2,5 %), trombocytopeni (21,7 %) og neutropeni
English: • Redness of the skin
Danish: • Rødme i huden
English: VO D VO D post HSCT
Danish: VOD VOD efter HSCT
English: The pharmacokinetics (PK) of gemtuzumab ozogamicin is described by measuring PK characteristics of the antibody (hP67.6) as well as total and unconjugated calicheamicin derivatives.
Danish: Farmakokinetikken (PK) for gemtuzumab ozogamicin beskrives ved måling af PKkarakteristika for antistoffet (hP67.6) samt samlede og ukonjugerede calicheamicin-derivater.
English: Based on a population PK analysis in 406 patients, the clearance of gemtuzumab ozogamicin in patients with mild renal impairment (creatinine clearance [CLcr] 60-89 mL/min; n=149) or moderate renal impairment (CLcr 30-59 mL/min; n=47), was similar to patients with normal renal function (CLcr ≥ 90 mL/min; n=209).
Danish: Baseret på farmakokinetiske populationsanalyser af 406 patienter er clearance af gemtuzumab ozogamicin hos patienter med let nedsat nyrefunktion (CLcr 60-89 ml/min., n=149) eller moderat nedsat nyrefunktion (CLcr 30-59 ml/min., n=47), det samme som hos patienter med normal nyrefunktion (CLcr ≥ 90 ml/min., n=209).
English: • allergic reaction: experience a high-pitched whistling sound during breathing (wheezing), difficult breathing, shortness of breath or cough with or without mucous, hives, itching, swelling, or feeling fever and chills (signs of an infusion related reaction) during or shortly after the MYLOTARG infusion.
Danish: • allergisk reaktion: oplever en højlydt hvæsende lyd ved vejrtrækning, besværet vejrtrækning, åndenød eller hoste med eller uden slim, høfeber, kløe, hævelse eller feberfølelse og kuldegysninger (tegn på en reaktion som skyldes infusionen) under eller kort efter infusion med MYLOTARG.
English: Add the reconstituted MYLOTARG solution to a syringe with sodium chloride 9 mg/mL (0.9%) solution for injection to a final concentration between 0.075 mg/mL to 0.234 mg/mL.
Danish: Tilsæt rekonstitueret MYLOTARG opløsning til en sprøjte med natriumchlorid 9 mg/ml (0,9%) opløsning til indsprøjtning til en færdig koncentration på mellem 0,075 mg/ml og 0,234 mg/ml.
English: Use in patients with renal impairment
Danish: Anvendelse hos patienter med nedsat nyrefunktion
English: The main toxicities occurred in the liver, bone marrow and lymphoid organs, haematology parameters (decreased RBC mass and WBC counts, mainly lymphocytes), kidney, eye and male and female reproductive organs.
Danish: Toksicitet forekom overvejende i lever, knoglemarv og lymfeorganer, hæmatologiske parametre (nedsat erytrocytvolumen og antal leukocytter, hovedsageligt lymfocytter), nyrer, øjne samt hanlige og hunlige reproduktionsorganer.
English: Effect on UGT substrates
Danish: Virkning på UGT-substrater
English: Store the vial in the original carton to protect from light.
Danish: Hætteglasset opbevares i den oprindelige æske for at beskytte mod lys.
English: The lowest dose with embryo-foetal effects correlated with 9.7 times the human clinical exposure after the third human dose of 3 mg/m2, based on AUC168 (see section 4.6).
Danish: Den laveste dosis med embryo-føtal virkning svarede til 9,7 gange human klinisk eksponering efter tredje humane dosis på 3 mg/m2, baseret på AUC168 (se pkt.
English: The study showed that addition of MYLOTARG to intensive chemotherapy improved EFS (3 years: 50.6% versus 44.0%; HR 0.838; 95% CI: 0.706, 0.995; p=0.0431) in de novo AML owing to a reduced relapse risk, with a trend towards longer OS in the MYLOTARG arm which was not statistically significant (3 years: 72.4% versus 67.6%; HR 0.904; 95% CI: 0.721, 1.133; p=0.3799).
Danish: Studiet viste, at tilføjelse af MYLOTARG til intensiv kemoterapi forbedrede hændelsesfri overlevelse (3 år: 50,6 % versus 44,0 %; HR 0,838; 95 % CI: 0,706-0,995; p=0,0431) i de novo AML forårsaget af en reduceret risiko for tilbagefald med tendens til længerevarende OS i MYLOTARG-armen, som ikke var statistisk signifikant (3 år: 72,4 % versus 67,6 %; HR 0,904; 95 % CI: 0,721-1,133, p=0,3799).
English: In clinical studies, neutropenia, thrombocytopenia, anaemia, leukopenia, febrile neutropenia, lymphopenia, and pancytopenia, some of which were life-threatening or fatal, were reported (see section 4.8).
Danish: Der blevet indberettet neutropeni, trombocytopeni, anæmi, leukopeni, febril neutropeni, lymfopeni og pancytopeni, heraf visse tilfælde der var livstruende eller dødelige i kliniske studier (se pkt.
English: i. Hyperglycaemia includes the following reported PTs: Hyperglycaemia and Blood glucose increased#.
Danish: Hyperglykæmi omfatter følgende indberettede FT'er: Hyperglykæmi og forhøjet blodglukose#
English: • bleeding: have unusual bleeding, bleeding from your gums, bruising easily or getting nose bleeds on a regular basis.
Danish: • blødning: har unormal blødning, blødende tandkød, let ved at få blå mærker eller tilbagevendende næseblod.
English: Hepatotoxicity, including life-threatening, and sometimes fatal hepatic failure and VOD/SOS have been reported in patients treated with MYLOTARG (see section 4.8).
Danish: Der har været indberettet levertoksicitet, herunder livstruende, og somme tider dødeligt leversvigt og VOD/SOS hos patienter, der er blevet behandlet med MYLOTARG (se pkt.
English: Table 8.
Danish: Skema 8.
English: Medicines of this type (monoclonal antibodies) can cause infusion reactions such as a rash, shortness of breath, difficulty breathing, a tight chest, chills or fever, back pain.
Danish: Denne type lægemidler (monoklonale antistoffer) kan forårsage reaktioner i forbindelse med infusionen såsom udslæt, åndenød, vejrtrækningsbesvær, trykken for brystet, kuldegysninger eller feber og rygsmerter.
English: Hepatomegaly Jaundice
Danish: Hepatomegali
English: Reconstitute each 5 mg vial with 5 mL of water for injections to obtain a single-use solution of 1 mg/mL of gemtuzumab ozogamicin.
Danish: Rekonstituér hvert hætteglas af 5 mg med 5 ml vand til injektionsvæske for at få en engangsopløsning på 1 mg/ml gemtuzumab ozogamicin.
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelig (kan forekomme hos 1 ud af 100 personer):
English: r. Hyperbilirubinaemia includes the following reported PTs: Blood bilirubin increased and Hyperbilirubinaemia.
Danish: Hyperbilirubinanæmi omfatter følgende indberettede FT'er: forhøjet serumbilirubin og hyperbilirubinanæmi.
English: • After reconstitution, each ml of the concentrated solution contains 1 mg gemtuzumab ozogamicin.
Danish: • Efter rekonstitution indeholder hver ml af den koncentrerede opløsning 1 mg gemtuzumab ozogamicin.
English: l. Hypotension includes the following reported PTs: Hypotension and Blood pressure decreased.
Danish: Hypotension omfatter følgende indberettede FT'er: hypotension og nedsat blodtryk.
English: • If platelet count recovers to ≥ 100,000/mm3 within 14 days following the planned start date of the consolidation course: initiate consolidation therapy (see as described in Table 1).
Danish: 3 inden for 14 dage efter konsolideringsforløbets planlagte startdato, skal konsolideringsterapien igangsættes (se beskrivelse i Skema 1)
English: Kaplan-Meier plot of event-free survival by investigator assessment from study ALFA-0701 (mITT population)
Danish: Kaplan-Meier-kurven for hændelsesfri overlevelse (investigators vurdering) fra studiet ALFA-0701 (mITT population)
English: In monotherapy studies the most common adverse reactions (> 30%) included pyrexia, nausea, infection, chills, haemorrhage, vomiting, thrombocytopenia, fatigue, headache, stomatitis, diarrhoea, abdominal pain, and neutropenia.
Danish: I monoterapistudierne var de mest almindelige bivirkninger (> 30%) pyreksi, kvalme, infektion, kuldegysninger, blødning, opkastning, trombocytopeni, træthed, hovedpine, stomatitis, diarré, mavesmerter og neutropeni.
English: • anaemia: have headaches, feel tired, experience dizziness, or look pale .
Danish: • Blodmangel: får hovedpine, bliver træt, svimmel eller ser bleg ud.
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide is a substrate of P-glycoprotein (P-gp).
Danish: N-acetyl-gamma-calicheamicin dimethylhydrazid er et substrat af P-glykoprotein (P-gp) in vitro.
English: Intravenous use after reconstitution and dilution.
Danish: infusion efter rekonstitution og fortynding.
English: The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in monotherapy studies were infection, haemorrhage, multi-organ failure, and VOD.
Danish: De hyppigste (≥1 %) bivirkninger, der førte til permanent seponering i monobehandlingsstudierne, var infektion, multiorgansvigt og VOD.
English: c. Neutropenia includes the following reported PTs: Neutropenia, Granulocytopenia and Neutrophil count decreased.
Danish: Neutropeni omfatter følgende indberettede FT'er: Neutropeni, granulocytopeni og nedsat neutrofiltal.
English: Based on population pharmacokinetic (PK) analyses, the combination of gemtuzumab ozogamicin with hydroxyurea, DNR, and AraC is not predicted to cause clinically meaningful changes in the PK of hP67.6 or unconjugated calicheamicin.
Danish: Baseret på farmakokinetiske (PK) populationsanalyser forventes det ikke, at kombinationen med gemtuzumab ozogamicin og hydroxyurea, DNR og AraC vil forårsage klinisk meningsfulde ændringer i PK af hP67.6 eller ukonjugeret calicheamicin.
English: *Including fatal outcome.
Danish: dødeligt udfald.
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide had a low potential to inhibit the activities of P-gp, breast cancer resistance protein (BCRP), bile salt export pump (BSEP), multidrug resistance associated protein (MRP) 2, multidrug and toxin extrusion protein (MATE)1 and MATE2K, organic anion transporter (OAT)1 and OAT3, organic cation transporter (OCT)1 and OCT2, and organic anion transporting polypeptide (OATP)1B1 and OATP1B3 at clinically relevant concentrations.
Danish: In vitro havde N-acetyl-gamma-calicheamicin dimethylhydrazid lavt potentiale for at hæmme aktiviteten for P-gp, brystcancerresistent protein (BCRP), galdesalt-eksportpumpen (BSEP), multidrugresistance-protein (MRP) 2, multidrug and toxin extrusion-protein (MATE)1, og MATE2K, organisk aniontransporter (OAT)1 og OAT3, organisk kationtransporter (OCT) 2, organisk aniontransport-polypeptid (OATP) 1B1 og OATP1B3 ved klinisk relevante koncentrationer.
English: Due to the risk of VOD/SOS, signs and symptoms of VOD/SOS should be closely monitored; these may include elevations in ALT, AST, total bilirubin, and alkaline phosphatase, which should be monitored prior to each dose of MYLOTARG, hepatomegaly (which may be painful), rapid weight gain, and ascites.
Danish: Disse kan inkludere forhøjede værdier for ALAT, ASAT, total bilirubin og alkalisk fosfatase, som skal monitoreres før hver dosis MYLOTARG, hepatomegali (som kan være smertefuld), brat vægtøgning og ascites.