natgillin/translations-raw huggingface dataset:
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).
Når de cytogenetiske resultaterne bliver tilgængelige hos patienter med nydiagnosticeret de novo AML i kombinationsbehandling med MYLOTARG sammen med daunorubicin og cytarabin, bør den potentielle fordel af forsat behandling med MYLOTARG vurderes i forhold til risikoen for den enkelte patient (se pkt.
For patients being treated with MYLOTARG in combination with daunorubicin and cytarabine for newly diagnosed de novo AML, when cytogenetics testing results become available it should be considered whether the potential benefit of continuing treatment with MYLOTARG outweighs the risks for the individual patient (see section 5.1).
Gemtuzumab ozogamicin er et antistof-lægemiddelkonjugat (ADC) sammensat af det CD33-rettede monoklonale antistof (hP67.6; rekombinant humaniseret immunoglobulin [Ig] G4, kappa-antistof fremstillet af pattedyrcellekultur i NS0-celler), som er kovalent bundet til det cytotoksiske stof Nacetyl-gamma-calicheamicin.
Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanised immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin.
Nedsat hæmoglobin Nedsat antal trombocytter Nedsat antal hvide blodlegemer Nedsat antal (absolutte) lymfocytter Nedsat antal neutrofile Hyperglykæmi
Haemoglobin decreased Platelets decreased White blood cells decreased Lymphocytes (absolute) decreased
Uåbnede hætteglas: Opbevares i køleskab (2 °C - 8 °C).
Unopened vial: Store in a refrigerator (2°C-8°C).
Der bør træffes passende foranstaltninger til forebyggelse af udvikling af tumorlyserelateret hyperurikæmi, såsom hydrering, administration af antihyperurikæmiske eller andre midler til behandling af hyperurikæmi (se pkt.
Appropriate measures to help prevent the development of tumour lysis-related hyperuricaemia, such as hydration, administration of antihyperuricemic or other agents for treatment of hyperuricaemia should be taken (see section 4.4).
MYLOTARG + daunorubicin + cytarabin (N=131)
MYLOTARG + daunorubicin + cytarabine (N=131)
• infusionsreaktion: oplever symptomer, under eller kort efter infusion med MYLOTARG, såsom svimmelhed, nedsat vandladning, forvirring, opkastning, kvalme, hævelse, åndenød eller hjerterytmeforstyrrelser (dette kan skyldes en mulig livstruende komplikation, som kaldes tumorlysesyndrom).
• infusion reaction: experience during or shortly after MYLOTARG infusion symptoms such as dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (this may be a potentially life-threatening complication known as tumour lysis syndrome).
Forkortelse: FT = Foretrukken term a.
Abbreviat ion: P T =preferred t erm.
Seponering af MYLOTARG (se pkt.
Discontinue MYLOTARG (see section 4.4).
Sådan administreres MYLOTARG 4.
How MYLOTARG will be given 4.
De hyppigste (≥1 %) bivirkninger, der førte til permanent seponering i kombinationsbehandlingsstudiet, var trombocytopeni, VOD, blødning og infektion.
The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, haemorrhage and infection.
Der blev udført en systematisk litteraturgennemgang af studier fra 16 publicerede artikler plus US Expanded Access Study, som omfattede 454 patienter, for at evaluere MYLOTARG hos pædiatriske patienter med recidiverende eller refraktær AML, der fik MYLOTARG som enten monoterapi (enkelt eller fraktioneret dosering) eller kombinationsbehandling (se pkt.
A systematic literature review of studies was conducted to evaluate MYLOTARG in paediatric patients with relapsed or refractory AML, which included 454 patients receiving MYLOTARG either as a monotherapy (single or fractionated dosing) or combination therapy from 16 published papers plus the US Expanded Access Study (see section 4.8).
Relapssfri overlevelse (ved investigator)
Relapse-free survival (by Investigator)
• Der skal anvendes procedurer for korrekt håndtering og bortskaffelse af cytotoksiske lægemidler.
• Toxic waste disposal procedures prescribed for anticancer medicinal products must be used.
Behandling af patienter med svær infektion, blødning/hæmoragi eller andre virkninger af knoglemarvssuppression, herunder svær neutropeni eller vedvarende trombocytopeni, kan gøre det nødvendigt at udsætte dosering eller permanent seponere behandlingen med MYLOTARG (se pkt.
Management of patients with severe infection, bleeding/haemorrhage, or other effects of myelosuppression, including severe neutropenia or persistent thrombocytopenia, may require a dose delay or permanent discontinuation of MYLOTARG (see section 4.2).
Unormal leverfunktion omfatter følgende indberettede FT'er: unormal leverfunktionstest og unormal hepatisk funktion.
t. Hepatic function abnormal includes the following reported PTs: Liver function test abnormal and Hepatic function abnormal.
I et fertilitetsstudie hos hunrotter blev der observeret lidt lavere antal corpora lutea og øget embryomortalitet med maternel toksicitet (ved ca. 9,7 gange human klinisk eksponering efter den tredje humane dosis på 3 mg/m2 baseret på AUC168).
In a female rat fertility study slightly lower numbers of corpora lutea and increased embryolethality were observed in the presence of maternal toxicity (approximately 9.7 times, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).
ALFA-0701-studie hos tidligere ubehandlede patienter med de novo AML Sikkerhed og virkning af MYLOTARG er blevet vurderet i et multicenter, randomiseret, open-label fase 3-studie, hvor man sammenlignede tilføjelse af MYLOTARG til et standard kemoterapiinduktionsregimen med daunorubicin og cytarabin (DA) kontra DA alene.
The efficacy and safety of MYLOTARG were evaluated in a multicentre, randomised, open-label Phase 3 study comparing the addition of MYLOTARG to a standard chemotherapy induction regimen of daunorubicin and cytarabine (DA) versus DA alone.
MYLOTARG daunorubicin cytarabin hydroxyurea
MYLOTARG daunorubicin cytarabine hydroxyurea
Gemtuzumab ozogamicins virkninger på andre lægemidler
Effect of other medicinal products on gemtuzumab ozogamicin
• Lungebetændelse, som giver hoste og besværet vejrtrækning
• Interstitial pneumonia (inflammation of the lungs causing coughing and difficulty breathing)
Virkning på lægemiddel-transportsubstrater
Effect on drug transporter substrates
Hvis patienten oplever VOD/SOS, bør MYLOTARG afbrydes og patienten behandles iht.
In patients who experience VOD/SOS, MYLOTARG should be discontinued and patients treated according to standard medical practice.
Behandling af symptomer på levertoksicitet kan kræve dosisafbrydelse eller seponering af MYLOTARG (se pkt.
Management of signs or symptoms of hepatic toxicity may require a dose interruption, or discontinuation of MYLOTARG (see section 4.2).
Gemtuzumab ozogamicin er et antistof-lægemiddelkonjugat (ADC) sammensat af det CD33-rettede monoklonale antistof (hP67.6), der er kovalent bundet til det cytotoksiske stof N-acetyl-gammacalicheamicin.
Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of CD33-directed monoclonal antibody (hP67.6) that is covalently linked to the cytotoxic agent N-acetyl-gamma calicheamicin.
Hypertension omfatter følgende indberettede FT'er: hypertension og forhøjet blodtryk.
m. Hypertension includes the following reported PTs: Hypertension and Blood pressure increased.
Konsolideringsforløb 1
Consolidation Course 1a,b
Der bør træffes passende foranstaltninger til forebyggelse af udvikling af tumorlyserelateret hyperurikæmi, såsom hydrering, administration af antihyperurikæmiske (fx allopurinol) midler eller andre midler til behandling af hyperurikæmi (fx rasburikase).
Appropriate measures to help prevent the development of tumour lysis-related hyperuricaemia, such as hydration, administration of antihyperuricemics (e.g., allopurinol) or other agents for treatment of hyperuricaemia (e.g., rasburicase) must be taken.
Hændelsesfri overlevelse (investigators vurdering) i forhold til AML risikoklassifikation fra studie ALFA-0701 (mITT Population)
Event-free survival by investigator assessment by AML risk classifications from study ALFA-0701 (mITT Population)
• Omfattende væskeansamling i underlivet/maven
• Excessive accumulation of fluid in the abdomen/stomach
5.1) med gemtuzumab ozogamicin kombineret med intensiv førstelinjebehandling hos 1.063 nyligt diagnosticerede børn (93,7 % af patienterne <18 år) og unge (6,3 % af patienterne) med de novo AML i alderen 0 til 29 år, var sikkerhedsprofilen den samme som den, der blev observeret i andre studier med gemtuzumab ozogamicin kombineret med intensiv kemoterapi hos voksne patienter med de novo AML.
In the completed randomised paediatric Phase 3 Study AAML0531 (see section 5.1) of gemtuzumab ozogamicin combined with intensive first-line therapy in 1,063 newly diagnosed children (93.7% of patients <18 years of age), and young adults (6.3% of patients) with de novo AML aged 0 to 29 years, the safety profile was similar with that observed in the other studies of gemtuzumab ozogamicin combined with intensive chemotherapy in adult patients with de novo AML.