natgillin/translations-raw huggingface dataset:
Den maksimale tid fra rekonstituering til fuldendt administration skal være ≤ 8 timer, og der skal være
The maximum time from reconstitution through the end of administration should be ≤ 8 hours, with ≤
I et randomiseret klinisk studie af patienter med recidiverende eller refraktær ALL (Studie 1) blev der målt maksimale stigninger i QTcF interval på ≥ 30 msek og ≥ 60 msek fra baseline hos henholdsvis 30/162 (19 %) og 4/162 (3 %) patienter i inotuzumab ozogamicin-armen henholdsvis 18/124 (15 %) og 3/124 (2 %) i behandlingsarmen med investigators valg af kemoterapi.
In a randomised clinical study in patients with relapsed or refractory ALL (Study 1), maximum increases in QTcF interval of ≥ 30 msec and ≥ 60 msec from baseline were measured in 30/162 (19%) and 4/162 (3%) patients in the inotuzumab ozogamicin arm, respectively, versus18/124 (15%) and 3/124 (2%) in the Investigator's choice of chemotherapy arm, respectively.
Lægen vil regelmæssigt tage blodprøver for at måle leverenzymer under behandlingen med BESPONSA.
Your doctor will take regular blood tests to monitor your liver enzymes during treatment with BESPONSA.
Hos nogle patienter, der fik inotuzumab ozogamicin, er der indberettet neutropeni- og trombocytopenirelaterede komplikationer (herunder hhv. infektioner og blødning/hæmoragi) (se pkt.
In patients receiving inotuzumab ozogamicin, complications associated with neutropenia and thrombocytopenia (including infections and bleeding/haemorrhagic events, respectively) were reported in some patients (see section 4.8).
Trombocyttallet ≥ 50 × 10 9/l a
Platelet count was ≥ 50 × 109/La
Hos patienter med recidiverende eller refraktær ALL behandlet med inotuzumab ozogamicin ved den anbefalede startdosis på 1,8 mg/m2/cyklus (se pkt.
In patients with relapsed or refractory ALL treated with inotuzumab ozogamicin at the recommended starting dose of 1.8 mg/m2/cycle (see section 4.2), steady-state exposure was achieved by Cycle 4.
• Den fortyndede opløsning infunderes over 1 time ved en hastighed på 50 ml/time ved stuetemperatur (20-25 °C).
• Infuse the diluted solution for 1 hour at a rate of 50 mL/h at room temperature (20 °C-25 °C).
NOAEL blev ikke identificeret for påvirkning af reproduktionsorganerne hos handyr, som blev observeret ved ca. 0,3 gange den kliniske eksponering hos mennesker baseret på AUC (se pk t. 4.6).
The NOAEL was not identified for the effects on male reproductive organs, which were observed at approximately 0.3 times the human clinical exposure based on AUC.
Du vil muligvis få medicin og ekstra væske, inden du bliver behandlet med BESPONSA, for at forhindre, at der opstår tumorlysesyndrom.
Before your treatment with BESPONSA, you may be given medicines and be hydrated to prevent tumour lysis syndrome from occurring.
Forlænget QT-interval ved EKG (1 %)
ECG QT prolonged (1%) Increased amylase (5%)
Raten blev defineret som antal patienter, der opnåede MRD-negativitet divideret med det samlede antal patienter, der opnåede CR/CRi ifølge EAC.
d Rate was defined as number of patients who achieved MRD negativity divided by the total number of patients who achieved CR/CRi per EAC. e PFS was defined as the time from date of randomisation to earliest date of the following events: death,
I pivotalstudiet (N = 164) blev der indberettet blødning/hæmoragiske hændelser, de fleste af mild sværhedsgrad, hos 54 (33 %) patienter.
In the pivotal clinical study (N=164), bleeding/haemorrhagic events, mostly mild in severity, were reported in 54/ (33%) patients.
• Hvis den fortyndede opløsning opbevares i køleskab (2-8 °C), skal den stå ved stuetemperatur (20-25 °C) i ca. 1 time inden administration.
• If the diluted solution is stored in a refrigerator (2 °C-8 °C), it must be allowed to equilibrate at room temperature (20 °C-25 °C) for approximately 1 hour prior to administration.
Der er indberettet neutropeni, trombocytopeni, anæmi, leukopeni, febril neutropeni, lymfopeni og pancytopeni, heraf livstruende tilfælde, hos patienter, der fik inotuzumab ozogamicin (se pkt.
In patients receiving inotuzumab ozogamicin, neutropenia, thrombocytopenia, anaemia, leukopenia, febrile neutropenia, lymphopenia, and pancytopenia, some of which were life-threatening, have been reported (see section 4.8).
- Bruges straks eller opbevares i køleskab (2-8 °C) i op til 4 timer.
- Use immediately or store in a refrigerator (2 °C-8 °C) for up to 4 hours.
• Omfattende væskeansamling i underlivet
• Excessive accumulation of fluid in the abdomen
BESPONSA 1 mg pulver til koncentrat til infusionsvæske, opløsning
BESPONSA 1 mg powder for concentrate for solution for infusion
9/l, og/eller trombocyttallet < 50 × 10
ANC was < 1 × 109/L and/or platelet count was < 50 × 109/La
Det virksomme stof i BESPONSA er inotuzumab ozogamicin.
The active ingredient in BESPONSA is inotuzumab ozogamicin.
Det anbefales at bruge en infusionsbeholder af polyvinylchlorid (PVC) (med eller uden di(2-ethylhexyl) phthalat (DEHP)), polyolefin (polypropylen og/eller polyethylen) eller ethylenvinylacetat (EVA).
An infusion container made of polyvinyl chloride (PVC) (di(2-ethylhexyl)phthalate [DEHP]- or non-DEHP-containing), polyolefin (polypropylene and/or polyethylene), or ethylene vinyl acetate (EVA) is recommended.
+) recidiverende eller refraktær CD22-positiv B-celle prækursor ALL skal have behandlingssvigt efter mindst 1 tyrosinkinasehæmmer (TKI).
Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).
ANC var < 1 × 10
ANC was ≥ 1 × 109/L
Foretag komplet blodtælling inden hver dosis BESPONA, og undersøg om der er symptomer på infektion under behandlingen og efter HSCT (se pkt.
Complete blood counts should be monitored prior to each dose of BESPONSA and signs and symptoms of infection during treatment and after HSCT (see section 5.1), bleeding/haemorrhage, and other effects of myelosuppression should be monitored during treatment.
4.4 vedrørende klinisk behandling af infektioner.
For clinical management of infections, see section 4.4.
- Opbevares i køleskab (2-8 °C).
- Store in a refrigerator (2 °C-8 °C).
Seponer behandlingen permanent, hvis total bilirubin ikke restituerer til ≤ 1,5 × ULN, eller ASAT/ALAT ikke restitierer til ≤ 2,5 × ULN (se Skema 3 og pkt.
Permanently discontinue treatment if total bilirubin does not recover to ≤ 1.5 × ULN or AST/ALT does not recover to ≤ 2.5 × ULN (see Table 3 and section 4.4).
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du:
Talk to your doctor, pharmacist or nurse before using BESPONSA if you:
4.4 og 4.8).
[2.6 to 4.7]
Brug af anden medicin sammen med BESPONSA
Other medicines and BESPONSA
Blødning omfatter også andre typer af blødning (17 %).
c Haemorrhage also includes other types of haemorrhage (17%).
Efter rekonstituering indeholder hvert hætteglas 0,25 mg/ml inotuzumab ozogamicin.
After reconstitution each vial contains 0.25 mg/mL of inotuzumab ozogamicin.
Virkning og anvendelse 2.
What BESPONSA is and what it is used for 2.
• Ændre hjertets elektriske aktivitet (forlænge QT-intervallet) (se afsnit 2), der kan give alvorlig uregelmæssig hjerterytme.
• QT interval prolongation (see section 2); signs and symptoms include a change in electrical activity of the heart that can cause serious irregular heart rhythms.
CI]
Or
Inden behandling af patienter med høj tumorbyrde anbefales præmedicinering for at reducere urinsyreniveauet i blodet og hydrering (se pkt.
For patients with a high tumour burden, pre-medication to reduce uric acid levels and hydration is recommended prior to dosing (see section 4.4).
• har haft symptomer på tumorlysesyndrom, der kan være forbundet med symptomer i maven og tarmene (fx kvalme, opkastning, diarré), hjertet (fx ændringer i hjerterytmen), nyrerne (fx mindre mængde urin, blod i urinen), nerverne og musklerne (fx muskelspasmer, muskelsvækkelse, muskelkramper) under eller kort efter infusionen af BESPONSA.
• have signs and symptoms of tumour lysis syndrome, which may be associated with symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps), during or shortly after the BESPONSA infusion.
4.4 vedrørende klinisk behandling af TLS.
For clinical management of TLS, see section 4.4.
Hvis ANC og/eller trombocyttallet falder, skal næste cyklus afbrydes, indtil mindst et af følgende sker: - ANC og trombocyttallet restitueres til mindst baselineniveau for det foregående forløb, eller - ANC ≥ 1 × 10
If ANC and/or platelet count decreases, interrupt the next cycle of treatment until at least one of the following occurs: - ANC and platelet count recover to at least baseline levels for the prior cycle, or - ANC recovers to ≥ 1 × 109/L and platelet count recovers to ≥ 50 × 109/La, or - Stable or improved disease (based on most recent bone marrow assessment) and the ANC and platelet count decrease is considered to be due to the underlying disease (not considered to be BESPONSA-related toxicity).
Tumorlysesyndrom er forbundet med forskellige symptomer i maven og tarmene (fx kvalme, opkastning, diarré), hjertet (fx ændringer i hjerterytmen), nyrerne (fx mindre mængde urin, blod i urinen), nerverne og musklerne (fx muskelspasmer, muskelsvækkelse, muskelkramper).
Tumour lysis syndrome is associated with a variety of symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps).
Se i pkt.
(see below).
Baseret på ikke-kliniske fund anses inotuzumab ozogamicin for at have potentiale til at påvirke reproduktion og fertilitet hos mænd og kvinder (se pkt.
Inotuzumab ozogamicin is considered to have the potential to impair reproductive function and fertility in men and women based on non-clinical findings (see section 4.6).
social rolle (64,7 versus 53,4: forbedringsgrad lille), fysisk funktionsdygtighed (75,0 versus 68,1: forbedringsgrad lille), social funktionsdygtighed (68,1 versus 59,8: forbedringsgrad medium) og appetittab (17,6 versus 26,3: forbedringsgrad lille) sammenlignet med investigators valg af kemoterapi.
Patient-reported outcomes measured using the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), were significantly better for BESPONSA by estimated mean postbaseline scores (BESPONSA and Investigator's choice of chemotherapy, respectively) for role functioning (64.7 versus 53.4, improvement grade small), physical functioning (75.0 versus 68.1, improvement grade small), social functioning (68.1 versus 59.8, improvement grade medium), and appetite loss (17.6 versus 26.3, improvement grade small) compared to Investigator's choice of chemotherapy.
Hvis den rekonstituerede opløsning ikke kan bruges med det samme, kan den opbevares i køleskab (2-8 °C) i op til 4 timer.
If the reconstituted solution cannot be used immediately, it may be stored in a refrigerator (2 °C-8 °C) for up to 4 hours.
(herunder sepsis og bakteriæmi (17 %), svampeinfektion (9 %), nedre luftvejsinfektion (12 %), øvre luftvejsinfektion (12 %), bakteriel infektion (1 %), virusinfektion (7 %), gastrointestinal infektion (4 %), hudinfektion (4 %))
Infection (48%)a (includes Sepsis and Bacteraemia [17%], Fungal infection [9%], Lower respiratory tract infection [12%)], Upper respiratory tract infection [12%], Bacterial infection [1%], Viral infection [7%], Gastrointestinal infection [4%], Skin infection [4%])
Lægen vil regelmæssigt tage blodprøver for at måle dine blodtal under behandlingen med BESPONSA, se også afsnit 4.
Your doctor will take regular blood tests to monitor your blood counts during treatment with BESPONSA.
For at reducere urinsyreniveauet anbefales det, at præmedicinere og hydrere patienter med høj tumorbyrde inden behandlingen påbegyndes (se pkt.
Pre-medication to reduce uric acid levels and hydration is recommended prior to dosing for patients with a high tumour burden (see section 4.2).
Træk denne mængde op af hætteglasset/-glassene vha. en sprøjte.
Withdraw this amount from the vial(s) using a syringe.
Seponer behandlingen permanent, hvis total bilirubin restituere til ≤ 1,5 × ULN, eller ASAT/ALAT ikke restituere til ≤ 2,5 × ULN (se pkt.
Permanently discontinue treatment if total bilirubin does not recover to ≤ 1.5 × ULN or AST/ALT does not recover to ≤ 2.5 × ULN (see section 4.4).
Efter rekonstituering indeholder 1 ml opløsning 0,25 mg inotuzumab ozogamicin.
After reconstitution, 1 mL of solution contains 0.25 mg inotuzumab ozogamicin.
Hos patienter med cirkulerende lymfoblaster anbefales cytoreduktion med en kombination af hydroxyurea, steroid, og/eller vincristin til et perifert blasttal ≤ 10.000/mm
For patients with circulating lymphoblasts, cytoreduction with a combination of hydroxyurea, steroids,
• Hvis behandlingen fungerer godt, men du ikke skal have en stamcelletransplantation, får du op til højst 6 behandlingsforløb.
• If the medicine works well, but you are not going to receive a stem cell transplant (see section
Blødning c (33 %) (herunder blødning i centralnervesystemet (1 %), øvre gastrointestinal blødning (6 %), nedre gastrointestinal blødning (4 %), næseblod (15 %)
Haemorrhagec (33%) (includes Central nervous system haemorrhage [1%], Upper gastrointestinal haemorrhage [6%], Lower gastrointestinal haemorrhage [4%], Epistaxis
Der er ikke udført studier af inotuzumab ozogamicin hos patienter med nedsat leverfunktion.
No formal pharmacokinetic studies of inotuzumab ozogamicin have been conducted in patients with hepatic impairment.
4.4 vedrørende klinisk behandling af blødning/hæmoragiske hændelser.
For clinical management of bleeding/haemorrhagic events, see section 4.4.
• Tumorlysesyndrom (se afsnit 2), dette kan give forskellige symptomer i mave-tarmkanalen (fx kvalme, opkastning og diarre), hjertet (fx ændringer i hjerterytmen), nyrerne (fx nedsat mængde urin, blod i urinen), nerver og muskler (muskelspasmer, -svaghed og -kramper)
• tumour lysis syndrome (see section 2); this may be associated with a variety of symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhoea), heart (for example, changes in the rhythm), kidney (for example, decreased urine, blood in urine), and nerves and muscles (for example, muscular spasms, weakness, cramps).
Behandling af visse bivirkninger kan nødvendiggøre dosisafbrydelse og/eller -nedsættelse eller permanent seponering af BESPONSA (se pkt.
Management of some adverse drug reactions may require dosing interruptions and/or dose reductions, or permanent discontinuation of BESPONSA (see sections 4.4 and 4.8).
• har symptomer på et lavt antal blodlegemer, der kaldes for neutrofile (nogen gange ledsaget af feber), røde blodlegemer, hvide blodlegemer, lymfocytter eller et lavt antal blodplader.
• have signs or symptoms of a low number of blood cells known as neutrophils (sometimes accompanied with fever), red blood cells, white blood cells, lymphocytes, or a low number of blood components known as platelets; these signs and symptoms include developing an infection or fever or bruising easily or getting frequent nose bleeds.
4.4 vedrørende klinisk behandling af infusionsrelaterede hændelser.
For clinical management of infusion related reactions, see section 4.4.
Den rekonstituerede opløsning skal bruges straks eller efter opbevaring i køleskab (2-8 °C) i op til 4 timer.
Use reconstituted solution immediately or after being stored in a refrigerator (2 °C-8 °C) for up to 4 hours.
Der er ikke udført studier af inotuzumab ozogamicin hos patienter med nedsat nyrefunktion.
No formal pharmacokinetic studies of inotuzumab ozogamicin have been conducted in patients with renal impairment.
Opbevaringstider og -forhold for rekonstitueret og fortyndet BESPONSA opløsning.
The storage times and conditions for reconstitution, dilution, and administration of BESPONSA are shown below.
4.8 og 5.2).
[4.5 to 7.9]
Gennemsnitlig OS, måneder [95 % CI]
Median OS; months [95% CI]
Patienter med MLL-genrearrangement (mixed lineage leukemia), inklusive t(4;11), der generelt havde lavere CD22 ekspression inden behandlingen, havde et dårligere OS-resultat efter behandling med BESPONSA eller investigators valg af kemoterapi.
CD22 expression prior to treatment, had a worse OS outcome following treatment with BESPONSA or Investigator's choice of chemotherapy.
Dosis (mg/m Længde på cyklus
Dosing regimen for Cycle 1 All patients: Dose (mg/m2) Cycle length
QT-intervallet skal observeres, når disse lægemidler administreres samtidigt (se pkt.
The QT interval should be monitored in case of combinations of such medicinal products (see sections 4.4, 4.8, and 5.2).
i.v.
SN:
28 dage
28 dayse
Med ≤ 4 timer mellem rekonstituering og fortynding.
a With ≤4 hours between reconstitution and dilution.
med ≤4 timer i mellem rekonstituering og fortynding.
a With ≤ 4 hours between reconstitution and dilution.
Der er indberettet infusionsrelaterede reaktioner hos patienter, der fik inotuzumab ozogamicin (se pkt.
In patients receiving inotuzumab ozogamicin, infusion related reactions were reported (see section 4.8).
≤ 4 timer mellem rekonstituering og fortynding.
4 hours between reconstitution and dilution.
Gennemsnitlig DoR f, måneder [95% CI]
Median PFSe, f; months [95% CI]
CR defineres som < 5% blaster i knoglemarven og fravær af leukæmiske blaster i perifert blod, fuld restitution af perifere blodtal (trombocytter ≥ 100 × 109/l og ANC ≥ 1 × 109/l) og resolution af eventuel ekstramedullær sygdom.
c CR is defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, full recovery of peripheral blood counts (platelets ≥ 100 × 109/L and ANC ≥ 1 × 109/L) and resolution of any extramedullary disease.
28 patienter havde fået 1 TKI tidligere og 17 patienter havde fået 2 TKI'ere tidligere.
Of the 49 (15%) patients with Ph+ ALL, 4 patients did not receive a prior TKI, 28 patients received 1 prior TKI, and 17 patients received 2 prior TKIs.
I første cyklus anbefales en samlet dosis til alle patienter på 1,8 mg/m 2 pr. forløb, givet som 3 opdelte doser på dag 1 (0,8 mg/m 2), 8 (0,5 mg/m 2) og 15 (0,5 mg/m 2).
For the first cycle, the recommended total dose of BESPONSA for all patients is 1.8 mg/m2 per cycle, given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2).
Ingen patienter havde en stigning i QTcF-intervallet på > 500 msek.
No patients had an increase in QTcF interval > 500 msec. Grade 2 QT interval prolongation was reported in 2/164 (1%) patients.
Kvinder skal bruge sikker prævention under behandlingen og i mindst 8 måneder efter sidste dosis.
You must avoid becoming pregnant or fathering a child. Women must use effective contraception during treatment and for at least 8 months after the last dose of treatment.
Der er indberettet TLS, som kan være livstruende eller dødelig, hos patienter, der fik inotuzumab ozogamicin (se pkt.
In patients receiving inotuzumab ozogamicin, TLS, which may be life-threatening or fatal, was reported (see section 4.8).
CR a, n (%) [95% CI]
CRa; n (%) [95% CI]
Hos patienter med både utilstrækkeligt knoglemarvsaspirat og utilstrækkelige cirkulerende blaster blev CD22ekspression vurderet ved hjælp af immunhistokemi.
Alternatively, CD22 expression was assessed using immunohistochemistry in patients with an inadequate bone marrow aspirate and insufficient circulating blasts.
CRi defineres som < 5% blaster i knoglemarven og fravær af leukæmiske blaster i perifert blod, delvis restitution af perifere blodtal (trombocytter < 100 × 109/l og/eller ANC < 1 × 109/l) og resolution af eventuel ekstramedullær sygdom.
b CRi, per EAC, was defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts, partial recovery of peripheral blood counts (platelets < 100 × 109/L and/or ANC < 1 × 109/L) and resolution of any extramedullary disease.
Der er observeret forlængelse af QT-intervallet hos patienter, der fik inotuzumab ozogamicin (se pkt.
In patients receiving inotuzumab ozogamicin, prolonged QT interval was observed (see section 4.4).
MRD-negativitet c for patienter, som opnåede CR/CRi, frekvens d (%) [95% CI] Gennemsnitlig PFS e, måneder [95% CI]
CRa/CRib; n (%) [95% CI] CRa; n (%) [95% CI] CRib; n (%) [95% CI] Median DoRf; months [95% CI]
CR a/CRi b, n (%) [95 % CI]
CRa/CRib; n (%) [95% CI]
- Bruges straks eller opbevares ved stuetemperatur (20-25 °C) eller i køleskab (2-8 °C).
- Use immediately or store at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
Der er indberettet stigninger i amylase og lipase hos patienter, der fik inotuzumab ozogamicin (se pkt.
In patients receiving inotuzumab ozogamicin, increases in amylase and lipase have been reported (see section 4.8).
Egnede patienter var ≥ 18 år og havde Philadelphia-kromosomnegativ (Ph
Eligible patients were ≥ 18 years of age with Philadelphia chromosome negative (Ph-) or Ph+ relapsed or refractory B-cell CD22-positive precursor ALL.
Patienter, der ikke har opnået CR c eller CRi
Patients who have not achieved a CRc or CRid: Dose (mg/m2)
Udseende og pakningsstørrelser
What BESPONSA looks like and contents of the pack
• Den fortyndede opløsning skal bruges straks, opbevares ved stuetemperatur (20-25 °C) eller i køleskab (2-8 °C).
• The diluted solution must be used immediately, stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
Den fortyndede opløsning skal bruges straks eller opbevares ved stuetemperatur (20-25 °C) eller i køleskab (2-8 °C).
The diluted solution must be used immediately or stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
I kliniske studier hos patienter med recidiverende eller refraktær ALL var den maksimale enkeltdosis og gentagne doser inotuzumab ozogamicin hhv. 0,8 mg/m 2 og 1,8 mg/m 2 pr. cyklus, givet som
In clinical studies in patients with relapsed or refractory ALL, the maximum single and multiple doses of inotuzumab ozogamicin were 0.8 mg/m2 and 1.8 mg/m2, respectively, per cycle, given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) (see section 4.2).
CRi b, n (%) [95 % CI]
CRib; n (%) [95% CI]
Ph
PC:
CRi blev ifølge EAC defineret som < 5 % blaster i knoglemarven og fravær af leukæmiske blaster i perifert blod, delvis restitution af perifere blodtal (trombocytter < 100 × 10
d CRi is defined as < 5% blasts in the bone marrow and the absence of peripheral blood leukaemic blasts,
I de efterfølgende cyklusser er den anbefalede, samlede dosis 1,5 mg/m 2 pr. cyklus givet som 3 opdelte doser på dag 1 (0,5 mg/m 2), 8 (0,5 mg/m 2) og 15 (0,5 mg/m 2) til patienter, der opnår CR/CRi, eller
For subsequent cycles, the recommended total dose is 1.5 mg/m2 per cycle administered as 3 divided doses on Days 1 (0.5 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who achieve a CR/CRi or 1.8 mg/m2 per cycle given as 3 divided doses on Days 1 (0.8 mg/m2), 8 (0.5 mg/m2), and 15 (0.5 mg/m2) for patients who do not achieve a CR/CRi.
Den fortyndede opløsning skal bruges straks eller efter opbevaring ved stuetemperatur (20-25 °C) eller i køleskab (2-8 °C).
Use diluted solution immediately or after being stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
0,4 gange den kliniske eksponering hos mennesker baseret på AUC.
Slight foetal growth retardation in rats also occurred at approximately 0.4 times the human clinical exposure based on AUC (see section 4.6).
For patienter, der forsætter med HSCT, anbefales en behandlingsvarighed med inotuzumab ozogamicin på 2 cyklusser for at mindske risikoen for VOD/SOS.
Due to the risk of VOD/SOS, for patients proceeding to HSCT, the recommended duration of treatment with inotuzumab ozogamicin is 2 cycles; a third cycle may be considered for those patients who do not achieve a CR or CRi and MRD negativity after 2 cycles (see section 4.2).