natgillin/translations-raw huggingface dataset:
Forhøjede transaminaser omfatter følgende indberettede FT'er: transaminaser forøget, hepatocellulær skade, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase og forhøjet hepatisk enzym.
q. Transaminases increased includes the following reported PTs: Transaminases increased, Hepatocellular injury, Alanine aminotransferase increased, Aspartate aminotransferase increased, and Hepatic enzyme increased.
Den fortyndede opløsning kan opbevares ved 2°C-8°C I op til 12 timer.
The diluted solution can be refrigerated at 2°C-8°C for up to 12 hours.
MYLOTARGs sikkerhed og virkning hos patienter, der er under 15 år, er ikke klarlagt.
The safety and efficacy of MYLOTARG in patients less than 15 years of age has not been established.
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.
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.
Erytem omfatter følgende indberettede FT'er: erytem ved katetersted, erytem og erytem på infusionssted w.
v. Erythema includes the following reported PTs: Catheter site erythema, Erythema and Infusion site erythema#.
• Nedsat antal røde blodlegemer (blodmangel), hvilket kan medføre træthed og åndenød
• Reduced number of red blood cells (anaemia) which may result in fatigue and shortness of breath
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.
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.
Patienterne bør underrettes om, at de kan opleve træthed, svimmelhed og hovedpine under behandling med MYLOTARG (se pkt.
Patients should be advised they may experience fatigue, dizziness and headache during treatment with MYLOTARG (see section 4.8).
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 %).
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%).
Udvalgte bivirkninger hos patienter, der fik MYLOTARG i kombinationsbehandlingsstudiet (ALFA-0701)
Selected** adverse reactions in patients who received MYLOTARG in combination therapy study (ALFA-0701)
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.
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).
• 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.
• 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.
• Den fortyndede opløsning indgives i 2 timer.
• Infuse the diluted solution for 2 hours.
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.
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).
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).
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).
N-acetyl-gamma-calicheamicin DMH (det frigivne cytotoksin) viste sig at være mutagent og klastogent.
N-acetyl gamma calicheamicin DMH (the released cytotoxin) was found to be mutagenic and clastogenic.
• Det anbefales at bruge en infusionsbeholder fremstillet af PVC med DEHP eller polyolefin (polypropylen og/eller polyætylen).
• It is recommended that the infusion container be made of polyvinyl chloride (PVC) with DEHP, or polyolefin (polypropylene and/or polyethylene).
Aktivering af Nacetyl-gamma-calicheamicin dimethylhydrazid inducerer brud på dobbeltstrenget DNA, hvorefter der induceres standsning af cellecyklus og apoptotisk celledød.
Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
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.
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.
Hvis der kræves endnu en induktion, må MYLOTARG ikke administreres under denne induktionsbehandling.
If a second induction is required, MYLOTARG should not be administered during second induction therapy.
Det lille molekyle, N-acetyl-gamma-calicheamicin, er et cytotoksisk semisyntetisk naturligt stof.
The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic semisynthetic natural product.
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 %).
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%).
• Forhøjet mængde urinsyre i blodet.
• High level of uric acid in the blood
Der er ikke indberettet tilfælde af Mylotarg overdosering fra klinisk praksis.
No cases of overdose with MYLOTARG were reported in clinical experience.
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.
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).
• Ødem (for meget væske i kroppen, fx hævelse af hænder og fødder)
• Oedema (excess fluid in body tissue, causing swelling of the hands and feet)
Efter markedsføring er der også indberettet (hyppighed ikke kendt) svampinfektioner i lungerne, herunder lungemykose og pneumocystosis jirovicii* samt bakterieinfektioner, herunder stenotrophomonasinfektion.
fungal lung infections including Pulmonary mycosis and Pneumocystis jirovecii pneumonia*; and bacterial infections including Stenotrophomonas infection were also reported.
De mest almindelige bivirkninger (>30 %) i studiet med kombinationsbehandling var blødning og infektion.
The most common adverse reactions (> 30%) in the combination therapy study were haemorrhage and infection.
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
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.
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.
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)
Ændringer af dosis og behandlingsplan
Dose and schedule modifications
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.
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).
MYLOTARG undergår ikke renal udskillelse, og farmakokinetikken hos patienter med alvorligt nedsat nyrefunktion er ukendt (se pkt.
MYLOTARG does not undergo renal clearance, the pharmacokinetics in patients with severe renal impairment is unknown (see section 5.2).
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.
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.
Ændret plan for behandling af hyperleukocytose med cytarabin Behandling sforløb
Schedule modification for the treatment of hyperleukocytosis with cytarabine
• Gulfarvning af huden eller det hvide i øjnene forårsaget af problemer i levereren eller blodet
• Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)
De hyppigste grad 3 blødning/hæmoragiske reaktioner var epistaxis (1,5 %), hæmoptyse (3,1 %) og hæmaturi (2,3 %).
The most frequent Grade 3 bleeding/haemorrhagic reactions were epistaxis (1.5%), haemoptysis (3.1%), and haematuria (2.3%).
Pyreksi omfatter følgende indberettede FT'er: pyreksi, forhøjet kropstemperatur og hypertermi.
w. Pyrexia includes the following reported PTs: Pyrexia, Body temperature increased, and Hyperthermia.
Adskillige enkeltstof-studier målte CD33-mætning efter MYLOTARG dosering hos patienter med recidiveret og refraktær AML.
Several single agent studies measured target (CD33) saturation post-MYLOTARG dose in patients with relapsed and refractory AML.
Median estimeret ud fra Kaplan-Meier kurven; CI baseret på Brookmeyer-Crowley metoden med log-log transformation.
a. Median estimated by Kaplan-Meier method; CI based on the Brookmeyer-Crowley method with log-log transformation.
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.
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).
MYLOTARGs sikkerhed og virkning hos børn og unge under 15 år med tidligere ubehandlet AML er ikke klarlagt (se pkt.
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).
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.
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.
In vitro-studier har påvist, at N-acetyl-gammacalicheamicin dimethylhydrazid bliver metaboliseret i stor udstrækning, primært via non-enzymatisk reduktion af disulfiddelen.
In vitro studies demonstrated that N-acetyl gamma calicheamicin dimethyl hydrazide is extensively metabolised, primarily via nonenzymatic reduction of the disulphide moiety.
daunorubicin + cytarabin (N=137)
daunorubicin + cytarabine (N=137)
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.
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.
Den primære metaboliske vej for gemtuzumab ozogamicin forventes at være hydrolytisk frigivelse af N-acetyl-gamma-calicheamicin dimethylhydrazid.
The primary metabolic pathway of gemtuzumab ozogamicin is anticipated to be hydrolytic release of N acetyl gamma calicheamicin dimethyl hydrazide.
28,0 (16,3 - ikke estimerbart)
28.0 [16.3, NE]
• Unormal leverfunktion
• Abnormal liver function
Patienterne bør monitoreres for levertoksicitet som anbefalet i pkt.
Patients should be monitored for hepatotoxicity as recommended in section 4.4.
Det leveres som en hvid/råhvid substans eller pulver.
It is supplied as white to off-white cake or powder.
• Betændelseslignende tilstand i urinblæren, der resulterer i blødning fra blæren.
• Inflammation of the urinary bladder resulting in bleeding from the bladder
• 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