natgillin/translations-raw huggingface dataset:
• Betændelseslignende tilstand i tarmene i forbindelse med et lavt antal hvide blodlegemer 
• Inflammation of the bowel in association with low white blood cell counts
Dosisændringer 
Dose modifications
Hvid til råhvid substans eller pulver. 
White to off-white cake or powder.
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. 
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.
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. 
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.
Når gemtuzumab ozogamicin binder til målet, bliver det internaliseret, og N-acetyl-calicheamicin frigives ved hydrolytisk fraspaltning. 
After gemtuzumab ozogamicin binds to the target it is internalised and N-acetyl calicheamicin is released by hydrolytic cleavage.
MYLOTARG har ikke været undersøgt hos patienter med alvorligt nedsat nyrefunktion. 
MYLOTARG has not been studied in patients with severe renal impairment.
I et embryo-føtalt toksicitetsstudie blev der observeret nedsat fostervægt, højere forekomst af føtal bølgede ribben og nedsat føtal knogledannelse. 
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.
Resultater fra ALFA-0701-studiet (mITT population) 
Efficacy results from study ALFA-0701 (mITT population)
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). 
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).
Træk denne mængde op af hætteglasset vha. en sprøjte. 
Withdraw this amount from the vial using a syringe.
N-acetyl-gamma-calicheamicin er kovalent bundet til antistoffet via en AcBut (4-(4-acetylfenolat) smørsyre)-binding. 
N-acetyl gamma calicheamicin is covalently attached to the antibody via an AcBut (4-(4-acetylphenoxy) butanoic acid) linker.
• Aktivt stof/aktive stoffer: gemtuzumab ozogamicin. 
• The active substance is gemtuzumab ozogamicin.
Forkortelser: AML = akut myeloid leukæmi; AraC = cytarabin; BMA = knoglemarvsaspirat, DNR = daunorubicin. 
Abbreviations: AML=acute myeloid leukaemia; AraC=cytarabine; BMA=bone marrow aspirate, DNR=daunorubicin.
Hændelsesfri overlevelse (ved investigator) 
Event-free survival (by Investigator)
Baseret på en farmakokinetisk populationsanalyse påvirker alder, race eller køn ikke omsætningen af gemtuzumab ozogamicins i væsentlig grad. 
Based on a population PK analysis, age, race, and gender did not significantly affect gemtuzumab ozogamicin disposition.
14 dage efter konsolideringsforløbets planlagte startdato (14 dage efter hæmatologisk restituering efter forgående cyklus), skal MYLOTARG seponeres (administrer ikke MYLOTARG i konsolideringscyklussen). 
• 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).
3 i mere end 14 dage, bør konsolideringsbehandling genovervejes, og der bør udføres BMA for at genvurdere patientens status. 
• 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.
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. 
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).
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. 
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).
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. 
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.
Det anbefales at præmedicinere med kortikosteroid, antihistamin og acetaminofen (eller paracetamol) 1 time inden dosering af MYLOTARG (se pkt. 
Premedication with a corticosteroid, antihistamine and acetaminophen (or paracetamol) is recommended 1 hour prior to MYLOTARG dosing (see section 4.2).
• Øvrige indholdsstoffer: dextran 40, saccharose, natriumchlorid, natriumdihydrogenphosfatmonohydrat, vandfri dinatriumphosfat. 
• The other ingredients are dextran 40, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous.
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. 
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.
Forkortelser: ALAT = alaninaminotransferase; ASAT = aspartataminotransferase; SOS = sinusoidalt obstruktionssyndrom; ULN = øvre normalgrænse; VOD = veno-okklusiv sygdom. 
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; SOS=sinusoidal obstruction syndrome; ULN=upper limit of normal; VOD=venoocclusive disease.
De sikkerhedsresultater, der blev observeret i en systematisk litteraturgennemgang af studier til evaluering af MYLOTARG hos pædiatriske patienter (se pkt. 
Safety results observed in a systematic literature review of studies evaluating MYLOTARG in paediatric patients (see section 5.1), are presented in Table 7.
Luftveje, thorax og mediastinum Meget almindelig Dyspnø 
Respiratory, thoracic and mediastinal disorders Very common Dyspnoean
MYLOTARG i behandling af tilbagefald af AML (9 mg/m Enkelttilfælde. 
***MYLOTARG in the treatment of relapsed AML (9 mg/m2).
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. 
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.
Almindelig (kan forekomme hos 1 ud af 10 personer): 
Common (may affect up to 1 in 10 people):
Dyspnø omfatter følgende indberettede FT'er: dyspnø og funktionsdyspnø. 
n. Dyspnoea includes the following reported PTs: Dyspnoea and Dyspnoea exertional.
dosisanbefalinger for konsolideringsforløbet. 
See Table 1 for dose recommendations for consolidation course.
I monobehandlingsstudierne omfattede de klinisk relevante alvorlige bivirkninger også infusionsrelaterede reaktioner (2,5 %), trombocytopeni (21,7 %) og neutropeni 
In monotherapy studies, clinically relevant serious adverse reactions also included infusion related reactions (2.5%), thrombocytopenia (21.7%), and neutropenia (34.3%).
• Rødme i huden 
• Redness of the skin
VOD VOD efter HSCT 
VO D VO D post HSCT
Farmakokinetikken (PK) for gemtuzumab ozogamicin beskrives ved måling af PKkarakteristika for antistoffet (hP67.6) samt samlede og ukonjugerede calicheamicin-derivater. 
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.
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). 
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).
• 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. 
• 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.
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. 
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.
Anvendelse hos patienter med nedsat nyrefunktion 
Use in patients with renal impairment
Toksicitet forekom overvejende i lever, knoglemarv og lymfeorganer, hæmatologiske parametre (nedsat erytrocytvolumen og antal leukocytter, hovedsageligt lymfocytter), nyrer, øjne samt hanlige og hunlige reproduktionsorganer. 
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.
Virkning på UGT-substrater 
Effect on UGT substrates
Hætteglasset opbevares i den oprindelige æske for at beskytte mod lys. 
Store the vial in the original carton to protect from light.
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. 
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).
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). 
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).
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. 
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).
Hyperglykæmi omfatter følgende indberettede FT'er: Hyperglykæmi og forhøjet blodglukose# 
i. Hyperglycaemia includes the following reported PTs: Hyperglycaemia and Blood glucose increased#.
• blødning: har unormal blødning, blødende tandkød, let ved at få blå mærker eller tilbagevendende næseblod. 
• bleeding: have unusual bleeding, bleeding from your gums, bruising easily or getting nose bleeds on a regular basis.
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. 
Hepatotoxicity, including life-threatening, and sometimes fatal hepatic failure and VOD/SOS have been reported in patients treated with MYLOTARG (see section 4.8).
Skema 8. 
Table 8.
Denne type lægemidler (monoklonale antistoffer) kan forårsage reaktioner i forbindelse med infusionen såsom udslæt, åndenød, vejrtrækningsbesvær, trykken for brystet, kuldegysninger eller feber og rygsmerter. 
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.
Hepatomegali 
Hepatomegaly Jaundice
Rekonstituér hvert hætteglas af 5 mg med 5 ml vand til injektionsvæske for at få en engangsopløsning på 1 mg/ml gemtuzumab ozogamicin. 
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.
Ikke almindelig (kan forekomme hos 1 ud af 100 personer): 
Uncommon (may affect up to 1 in 100 people):
Hyperbilirubinanæmi omfatter følgende indberettede FT'er: forhøjet serumbilirubin og hyperbilirubinanæmi. 
r. Hyperbilirubinaemia includes the following reported PTs: Blood bilirubin increased and Hyperbilirubinaemia.
• Efter rekonstitution indeholder hver ml af den koncentrerede opløsning 1 mg gemtuzumab ozogamicin. 
• After reconstitution, each ml of the concentrated solution contains 1 mg gemtuzumab ozogamicin.
Hypotension omfatter følgende indberettede FT'er: hypotension og nedsat blodtryk. 
l. Hypotension includes the following reported PTs: Hypotension and Blood pressure decreased.
3 inden for 14 dage efter konsolideringsforløbets planlagte startdato, skal konsolideringsterapien igangsættes (se beskrivelse i Skema 1) 
• 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).
Kaplan-Meier-kurven for hændelsesfri overlevelse (investigators vurdering) fra studiet ALFA-0701 (mITT population) 
Kaplan-Meier plot of event-free survival by investigator assessment from study ALFA-0701 (mITT population)
I monoterapistudierne var de mest almindelige bivirkninger (> 30%) pyreksi, kvalme, infektion, kuldegysninger, blødning, opkastning, trombocytopeni, træthed, hovedpine, stomatitis, diarré, mavesmerter og neutropeni. 
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.
• Blodmangel: får hovedpine, bliver træt, svimmel eller ser bleg ud. 
• anaemia: have headaches, feel tired, experience dizziness, or look pale .
N-acetyl-gamma-calicheamicin dimethylhydrazid er et substrat af P-glykoprotein (P-gp) in vitro. 
In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide is a substrate of P-glycoprotein (P-gp).
infusion efter rekonstitution og fortynding. 
Intravenous use after reconstitution and dilution.
De hyppigste (≥1 %) bivirkninger, der førte til permanent seponering i monobehandlingsstudierne, var infektion, multiorgansvigt og VOD. 
The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in monotherapy studies were infection, haemorrhage, multi-organ failure, and VOD.
Neutropeni omfatter følgende indberettede FT'er: Neutropeni, granulocytopeni og nedsat neutrofiltal. 
c. Neutropenia includes the following reported PTs: Neutropenia, Granulocytopenia and Neutrophil count decreased.
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. 
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.
dødeligt udfald. 
*Including fatal outcome.
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. 
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.
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. 
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.
Forkortelser: CR = komplet remission; CRp = komplet remission med ufuldstændig bedring af trombocyttal; CI = konfidensinterval; EFS = hændelsesfri overlevelse; mITT = modificeret intent-to-treat; n = tal; N = antal; NE = ikke estimerbart; OS = samlet overlevelse; RFS = relapsfri overlevelse. 
Abbreviations: CR=complete remission; CRp=complete remission with incomplete platelet recovery; CI=confidence interval; EFS=event-free survival; mITT=modified intent-to-treat; n=number; N=number; NE= not estimable; OS=overall survival; RFS=relapse-free survival.
Efter rekonstitution til en koncentration på 1 mg/ml er den ekstraherbare mængde i et hætteglas 4,5 mg (4,5 ml). 
When reconstituted to a 1 mg/mL concentration, the extractable content of one vial is 4.5 mg (4.5 mL).
Vend forsigtigt infusionsbeholderen om for at blande den fortyndede opløsning. 
Gently invert the infusion container to mix the diluted solution.
• Komplikation kaldet tumorlysesyndrom Fortæl straks din læge, hvis du oplever symptomer såsom svimmelhed, nedsat vandladning, forvirring, opkastning, kvalme, hævelse, åndenød eller hjerterytmeforstyrrelser. 
• Complication known as tumour lysis syndrome Tell your doctor right away if you experience dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances.
Mylotarg hætteglas indeholder 5 mg lægemiddel uden overskud. 
Mylotarg vials contain 5 mg of drug product with no overfill.
• Hvirvl infusionsbeholderen forsigtigt for at blande den fortyndede opløsning. 
• Gently invert the infusion container to mix the diluted solution.
Infektion omfatter sepsis og bakteriæmi (53,4 %), svampeinfektion (15,3 %), nedre luftvejsinfektion (5,3 %), 
a. Infection includes Sepsis and Bacteraemia (53.4%), Fungal infection (15.3%), Lower respiratory tract infection
Hver æske indeholder et ravgult hætteglas med en gummiprop og flip off-hætte med krympeforsegling. 
Each carton contains 1 amber, glass vial, with rubber stopper and crimp seal with flip-off cap.
3) AML anbefales cytoreduktion enten med leukaferese, oral hydroxyurea eller AraC med eller uden hydroxyurea for at reducere antallet af perifere hvide blodlegemer 48 timer inden administration af MYLOTARG. 
In patients with hyperleukocytic (leukocyte count ≥ 30,000/mm3) AML, cytoreduction is recommended either with leukapheresis, oral hydroxyurea or AraC with or without hydroxyurea to reduce the peripheral white blood cell (WBC) count 48 hours prior to administration of MYLOTARG.
Dosisændringer på grund af hæmatologisk toksicitet Hæmatologisk toksicitet 
Dose modifications for haematological toxicities Haematological toxicities
Dextran 40, saccharose, natriumchlorid, natriumdihydrogenphosfatmonohydrat, dinatriumphosphat, vandfri. 
Dextran 40, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous.
Baseret på en analyse over potentielle risikofaktorer er der en øget risiko for udvikling af VOD hos voksne patienter, der har fået MYLOTARG som monoterapi, enten før eller efter en hæmatopoietisk stamcelletransplantation (HSCT), samt hos patienter med moderat til svært nedsat leverfunktion (se pkt. 
Based on an analysis of potential risk factors, adult patients who received MYLOTARG as monotherapy, either before or after an haematopoietic stem cell transplant (HSCT), and patients with moderate or severe hepatic impairment are at increased risk for developing VOD (see section 4.8).
Dødelig blødning/hæmoragiske reaktioner blev indberettet for 3 (2,3 %) patienter (cerebralt hæmatom, intrakranialt hæmatom og subduralt hæmatom). 
Fatal bleeding/haemorrhagic reactions were reported in 3 (2.3%) patients (cerebral haematoma, intracranial haematoma, and subdural haematoma).
Baseret på Cox proportional hazards-model versus daunorubicin + cytarabin. 
b. Based on the Cox Proportional Hazards Model Versus daunorubicin+cytarabine.
• Unormale leverblodprøver (som kan antyde leverskade) 
• Abnormalities in liver blood tests (which can be indicators of liver injury)
MYLOTARG kan ikke bruges til patienter med den type kræft, som hedder promyelocyt leukæmi. 
MYLOTARG is not for use in patients with a type of cancer called acute promyelocytic leukaemia (APL).
Natriumdihydrogenphosfatmonohydrat Dinatriumphosfat, vandfri 
Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate anhydrous
• Se efter, om den rekonstituerede opløsning indeholder partikler eller er misfarvet. 
• Inspect the reconstituted solution for particulates and discolouration.
I toksicitetsstudierne udviklede rotter præ-neoplastiske læsioner (minimal til svag oval celle hyperplasi) i leveren ved ca. 54 gange human klinisk eksponering efter den tredje humane dosis på 3 mg/m baseret på AUC168. 
In toxicity studies, rats developed preneoplastic lesions (minimal to slight oval cell hyperplasia) in the liver approximately 54 times, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).