natgillin/translations-raw huggingface dataset:
The maternally toxic dose (approximately 2.3 times the human clinical exposure based on AUC) also resulted in foetal growth retardation, including decreased foetal weights and delayed skeletal ossification. 
Odmerek, toksičen za samice matere (približno 2,3-kratnik klinične izpostavljenosti pri ljudeh na podlagi vrednosti AUC), je povzročil tudi upočasnitev rasti ploda, vključno z zmanjšanjem telesne mase ploda in zapoznelo osifikacijo kosti.
Consider permanent discontinuation of BESPONSA. 
Razmislite o trajni prekinitvi zdravljenja z zdravilom BESPONSA.
In the pivotal study (N=164), infections, including serious infections, some of which were life-threatening or fatal, were reported in 79 (48%) patients. 
V ključnem preskušanju (n = 164) so o okužbah, vključno z resnimi okužbami, od katerih so bile nekatere življenjsko ogrožajoče ali smrtne, poročali pri 79 (48 %) bolnikih.
Regarding other risk factors, VOD/ SOS was reported in 6/11 (55%) patients who received a HSCT conditioning regimen containing 2 alkylating agents and 9/53 (17%) patients who received a HSCT conditioning regimen containing 1 alkylating agent, 7/17 (41%) patients who were ≥ 55 years old and 11/62 (18%) patients who were < 55 years old, and 7/12 (58%) patients with a serum bilirubin ≥ ULN prior to HSCT and in 11/67 (16%) patients with a serum bilirubin < ULN prior to HSCT. 
Glede na druge dejavnike tveganja so o VOD/SOS poročali pri 6/11 (55 %) bolnikov, ki so prejeli pripravljalno shemo za PKMC, ki je vključevala 2 alkilirajoča citostatika, in pri 9/53 (17 %) bolnikov, ki so prejeli pripravljalno shemo za PKMC, ki je vključevala 1 alkilirajoči citostatik, pri 7/17 (41 %) bolnikov, starih ≥ 55 let, in pri 11/62 (18 %) bolnikov, starih < 55 let, ter pri 7/12 (58 %) bolnikov, pri katerih je bila pred PKMC vrednost bilirubina v serumu ≥ ZMN, in pri 11/67 (16 %) bolnikov, pri katerih je bila pred PKMC vrednost bilirubina v serumu < ZMN.
Abbreviations: ALL=acute lymphoblastic leukaemia; ECG=electrocardiogram; GGT=gamma-glutamyltransferase; HSCT=haematopoietic stem cell transplant. 
Okrajšave: ALL = akutna limfoblastna levkemija; EKG = elektrokardiogram; GGT = gama-glutamiltransferaza; PKMC = presaditev krvotvornih matičnih celic.
A third cycle may be considered for those patients who do not achieve a CR/CRi and MRD negativity after 2 cycles. 
O 3. ciklu lahko razmislimo pri tistih bolnikih, ki po 2 ciklih ne dosežejo CR/CRi in negativnega izvida za MRD.
21 daysb Dosing regimen for subsequent cycles depending on response to treatment Patients who have achieved a CRc or CRid: Dose (mg/m2) Cycle length 
21 dni Režim odmerjanja za naslednje cikle glede na odziv na zdravljenje Bolniki, ki so dosegli CR c ali CRi odmerek (mg/m dolžina cikla
BESPONSA significantly increased the risk of VOD/SOS above that of standard chemotherapy regimens in this patient population. 
Pri tej populaciji bolnikov je zdravilo BESPONSA pomembno zvečalo tveganje za VOD/SOS nad tveganje pri standardnih režimih kemoterapije.
VOD/SOS was also reported in 18 patients after a subsequent HSCT. 
O VOD/SOS so poročali tudi pri 18 bolnikih, pri katerih so po zdravljenju opravili PKMC.
Of the 5 patients who experienced VOD/SOS during treatment with inotuzumab ozogamicin but without an intervening HSCT, 2 patients had also received an HSCT before BESPONSA treatment. 
Od 5 bolnikov, pri katerih se je med zdravljenjem z inotuzumab ozogamicinom, vendar brez posredovanja s PKMC, pojavila VOD/SOS, so pri 2 bolnikih pred zdravljenjem z zdravilom BESPONSA opravili tudi PKMC.
In patients in whom the serum bilirubin is ≥ ULN prior to HSCT, HSCT post BESPONSA treatment should only be undertaken after careful consideration of the benefit/risk. 
Pri bolnikih z vrednostjo bilirubina v serumu pred PKMC ≥ ZMN lahko PKMC po zdravljenju z zdravilom BESPONSA opravite šele po skrbnem pretehtanju razmerja med koristmi in tveganji.
In patients who tested positive for anti-inotuzumab ozogamicin antibodies, no effect on clearance of BESPONSA was detected based on population-pharmacokinetic analysis. 
Pri bolnikih, ki so bili pozitivni na protitelesa proti inotuzumab ozogamicinu, z analizo populacijske farmakokinetike niso odkrili učinkov na očistek zdravila BESPONSA.
Dose modifications depending on duration of dosing interruption due to toxicity Duration of dosing interruption due to toxicity 
Prilagoditve odmerkov glede na trajanje prekinitve odmerjanja zaradi toksičnosti
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). 
Obvladovanje nekaterih neželenih učinkov zdravila lahko zahteva prekinitve odmerjanja in/ali zmanjšanje odmerkov ali trajno prekinitev zdravljenja z zdravilom BESPONSA (glejte poglavji 4.4 in 4.8).
There was a trend in favour of BESPONSA for estimated mean postbaseline scores from the EuroQoL 5 Dimension (EQ-5D) questionnaire, (BESPONSA and Investigator's choice of chemotherapy, respectively) for the EQ-5D index (0.80 versus 0.76, minimally important difference for cancer = 0.06). 
Prisoten je bil trend v korist zdravila BESPONSA pri ocenjenih povprečnih rezultatih od izhodišča, ki so jih ocenjevali s petdimenzionalnim vprašalnikom EuroQoL (EQ-5D) (zdravilo BESPONSA v primerjavi s kemoterapijo po izbiri raziskovalca) glede kazalnika EQ-5D (0,80 v primerjavi z 0,76, minimalno pomembna razlika za raka = 0,06).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING VIAL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
• The active substance is inotuzumab ozogamicin. 
• Učinkovina je inotuzumab ozogamicin.
- Store in the original carton in order to protect from light. 
- Shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
In patients who received BESPONSA, the most common (≥ 2%) serious adverse reactions were infection (23%), febrile neutropenia (11%), haemorrhage (5%), abdominal pain (3%), pyrexia (3%), VOD/SOS (2%), and fatigue (2%). 
Pri bolnikih, ki so prejemali zdravilo BESPONSA, so bili najpogostejši (≥ 2 %) resni neželeni učinki okužba (23 %), febrilna nevtropenija (11 %), krvavitev (5 %), bolečine v trebuhu (3 %), pireksija (3 %), VOD/SOS (2 %) in utrujenost (2 %).
If you need treatment with BESPONSA, you must stop breast-feeding during treatment and for at least 2 months after treatment. 
Če potrebujete zdravljenje z zdravilom BESPONSA, med zdravljenjem in še najmanj 2 meseca po zdravljenju ne smete dojiti.
a Severity grade according to National Cancer Institute Common Terminology Criteria for Adverse Events 
Merila NCI za poenoteno terminologijo neželenih dogodkov (National Cancer Institute Common Terminology Criteria for Adverse Events), različica 3.0.
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). 
Odrasli bolniki z recidivno ali refraktarno prekurzorsko B-celično ALL s prisotnim kromosomom Philadelphia (Ph morajo biti predhodno neuspešno zdravljeni z vsaj 1 zaviralcem tirozin-kinaze (TKI - Tyrosine Kinase Inhibitor).
• infusion related reaction (see section 2); signs and symptoms include fever and chills or breathing problems during or shortly after the BESPONSA infusion. 
• z infuzijo povezane reakcije (glejte poglavje 2); znaki in simptomi vključujejo vročino in mrzlico ali težave z dihanjem med infundiranjem zdravila BESPONSA ali kmalu po njem.
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. 
Pred vsakim odmerkom zdravila BESPONSA je treba spremljati celotno krvno sliko, med zdravljenjem in po PKMC (glejte poglavje 5.1) je treba bolnike spremljati glede znakov in simptomov okužbe, med zdravljenjem pa je treba bolnike spremljati glede krvavitve in drugih učinkov mielosupresije.
Of the 9 patients with Ph+ B-cell ALL, 1 patient had received 1 previous TKI and 1 patient had received no prior TKIs. 
Od 9 bolnikov s Ph B-celično ALL je 1 bolnik prejel 1 predhodni TKI, 1 bolnik pa ni prejel predhodnih TKI.
Patients with relapsed or refractory ALL who have received 2 or more prior treatment regimens for ALL - Study 2 
Bolniki z recidivno ali refraktarno ALL, ki so za ALL prejeli 2 ali več predhodnih režimov zdravljenja - Študija 2
Administration of inotuzumab ozogamicin to female rats at the maternally toxic dose (approximately 2.3 times the human clinical exposure based on AUC) prior to mating and during the first week of gestation resulted in embryo-foetal toxicity, including increased resorptions and decreased viable embryos. 
Uporaba inotuzumab ozogamicina je pri podganjih samicah pri odmerku, ki je toksičen za samice matere (približno 2,3-kratnik klinične izpostavljenosti pri ljudeh na podlagi vrednosti AUC), pred parjenjem in v prvem tednu gestacije povzročila toksičnost za zarodek/plod, vključno z zvečano resorpcijo in zmanjšanim številom za življenje sposobnih zarodkov.
Abdominal pain (23%) Vomiting (15%) Diarrhoea (17%) Nausea (31%) Stomatitis (13%) Constipation (17%) 
Bolezni prebavil bolečine v trebuhu (23 %) bruhanje (15 %) diareja (17 %) navzea (31 %) stomatitis (13 %) zaprtje (17 %)
• Abnormally high levels of amylase (an enzyme needed for digestion and conversion of starch into sugars) in the blood 
• nenormalno visoke ravni amilaze (encima, ki je potreben za prebavo in pretvorbo škroba v sladkorje) v krvi
In all patients, liver tests should be monitored, including, ALT, AST, total bilirubin, and alkaline phosphatase, prior to and following each dose of BESPONSA. 
Pri vseh bolnikih je treba pred vsakim odmerkom zdravila BESPONSA in po njem spremljati jetrne teste, vključno z ALT, AST, celokupnim bilirubinom in alkalno fosfatazo.
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. 
Pri bolnikih z recidivno ali refraktarno ALL, ki so jih zdravili z inotuzumab ozogamicinom v priporočenem začetnem odmerku 1,8 mg/m2/cikel (glejte poglavje 4.2), so izpostavljenost v stanju dinamičnega ravnovesja dosegli do 4. cikla.
Patients with Ph+ B-cell precursor ALL were required to have failed treatment with at least 1 second or third generation TKI and standard chemotherapy. 
+ prekurzorsko B-celično ALL so morali biti predhodno neuspešno zdravljeni z vsaj 1 TKI druge ali tretje generacije in standardno kemoterapijo.
For instructions on reconstitution and dilution of BESPONSA before administration, see section 6.6. 
Za navodila glede rekonstitucije in redčenja zdravila BESPONSA pred dajanjem glejte poglavje 6.6.
The storage times and conditions for reconstitution, dilution, and administration of BESPONSA are shown below. 
Čas shranjevanja in pogoji rekonstitucije, redčenja in uporabe zdravila BESPONSA so prikazani spodaj.
The maximum time from reconstitution through the end of administration should be ≤ 8 hours, with ≤ 4 hours between reconstitution and dilution. 
Najdaljši čas od rekonstitucije do konca uporabe mora biti ≤ 8 ur, čas med rekonstitucijo in redčenjem pa ≤ 4 ure.
Patients with a history of liver disease should be carefully evaluated (e.g., ultrasound scan, viral hepatitis testing) prior to treatment with BESPONSA to exclude serious ongoing hepatic disease (see section 4.3). 
Bolnike z boleznijo jeter v anamnezi je treba pred zdravljenjem z zdravilom BESPONSA skrbno oceniti (npr. z ultrazvočnim slikanjem, testiranjem za virusni hepatitis) za izključitev prisotnosti resne bolezni jeter (glejte poglavje 4.3).
In 3 patients with hepatic impairment defined by NCI ODWG category C (total bilirubin > 1.5-3 × ULN and AST any level) and 1 patient with hepatic impairment defined by NCI ODWG category D (total bilirubin > 3 × ULN and AST any level), inotuzumab ozogamicin clearance did not appear to be reduced. 
Pri 3 bolnikih z okvaro jeter, kot jo opredeljuje kategorija C NCI ODWG (celokupni bilirubin > 1,5-3 × ZMN in katerakoli vrednost AST), in 1 bolniku z okvaro jeter, kot jo opredeljuje kategorija D NCI ODWG (celokupni bilirubin > 3 × ZMN in katerakoli vrednost AST), niso opazili, da bi bil očistek inotuzumab ozogamicina zmanjšan.
The no observed adverse effect level (NOAEL) for the effects on female reproductive organs in rats and monkeys was approximately 2.2 and 3.1 times the human clinical exposure based on AUC, respectively. 
Odmerek brez opaznega neželenega učinka (NOAEL - No Observed Adverse Effect Level) za učinke na ženske reprodukcijske organe pri podganah oziroma opicah je bil približno 2,2- oziroma 3,1-kratnik klinične izpostavljenosti pri ljudeh na podlagi vrednosti AUC.
Venoocclusive liver disease (sinusoidal obstruction syndrome) (3% [pre-HSCT]d) 
venookluzivna bolezen jeter (sindrom obstrukcije sinusoidov) (3 % [pred PKMC]
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. 
Priporočljiv je vsebnik za infuzijo iz polivinil klorida (PVC) (ki vsebuje ali ne vsebuje di-(2-etilheksil)ftalata (DEHP)), poliolefina (polipropilena in/ali polietilena) ali etilen-vinil acetata (EVA).
For patients not proceeding to HSCT, a maximum of 6 cycles may be administered. 
Pri bolnikih, pri katerih ne bodo opravili PKMC, lahko uporabimo največ 6 ciklov.
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. 
Odmerka NOAEL za učinke na moške reprodukcijske organe, ki so jih opazili pri približno 0,3-kratniku klinične izpostavljenosti pri ljudeh na podlagi vrednosti AUC, niso ugotovili.
The safety and efficacy of BESPONSA in patients with relapsed or refractory CD22-positive ALL were evaluated in an open-label, international, multicentre, Phase 3 study (Study 1) in which patients were randomised to receive BESPONSA (N=164 [164 received treatment) or Investigator's choice of chemotherapy (N=162 [143 received treatment]), specifically fludarabine plus cytarabine plus granulocyte colony-stimulating factor (FLAG) (N=102 [93 received treatment]), mitoxantrone/cytarabine (MXN/Ara-C) (N=38 [33 received treatment]), or high dose cytarabine (HIDAC) (N=22 [17 received treatment]). 
Varnost in učinkovitost zdravila BESPONSA pri bolnikih s CD22-pozitivno recidivno ali refraktarno ALL so ocenili v odprti, mednarodni, multicentrični študiji 3. faze (Študija 1), v kateri so bolnike randomizirali na prejemanje zdravila BESPONSA (n = 164; 164 jih je prejelo zdravljenje) ali na kemoterapijo po izbiri raziskovalca (n = 162; 143 jih je prejelo zdravljenje), natančneje fludarabin + citarabin + granulocitne kolonije stimulirajoči faktor (FLAG) (n = 102; 93 jih je prejelo zdravljenje), mitoksantron/citarabin (MXN/Ara-C) (n = 38; 33 jih je prejelo zdravljenje) ali velike odmerke citarabina (HiDAC) (n = 22; 17 jih je prejelo zdravljenje).
• Protect the intravenous bag from light using an ultraviolet light-blocking cover (i.e., amber, dark brown, or green bags or aluminium foil) during infusion. 
• Infuzijsko vrečko med infundiranjem zaščitite pred svetlobo s prekrivalom, ki ne prepušča ultravijolične svetlobe (tj. z rumenorjavimi, temnorjavimi ali zelenimi vrečkami ali aluminijasto folijo).
b Pancytopenia includes the following reported preferred terms: Bone marrow failure, Febrile bone marrow aplasia, and Pancytopenia. 
Pancitopenija vključuje naslednje priporočene izraze, o katerih so poročali: odpoved kostnega mozga, febrilna aplazija kostnega mozga in pancitopenija.
Among patients who proceeded to HSCT after BESPONSA treatment, VOD/SOS was reported in 5/11 (46%) patients who received an HSCT both prior to and after BESPONSA treatment and 13/68 (19%) patients who only received an HSCT after BESPONSA treatment. 
Od bolnikov, pri katerih so po zdravljenju z zdravilom BESPONSA opravili PKMC, so o VOD/SOS poročali pri 5/11 (46 %) bolnikov, pri katerih so PKMC opravili pred zdravljenjem z zdravilom BESPONSA in po njem, ter pri 13/68 (19 %) bolnikov, pri katerih so PKMC opravili samo po zdravljenju z zdravilom BESPONSA.
No patients tested positive for neutralising anti-inotuzumab ozogamicin antibodies. 
Noben bolnik ni bil pozitiven na nevtralizirajoča protitelesa proti inotuzumab ozogamicinu.
Medicines given before treatment with BESPONSA 
Zdravila, ki jih boste prejeli pred zdravljenjem z zdravilom BESPONSA
Depending on the severity of the infusion related reaction, discontinuation of the infusion or administration of steroids and antihistamines should be considered (see section 4.2). 
Glede na resnost z infuzijo povezane reakcije je treba razmisliti o prekinitvi infundiranja ali uporabi steroidov in antihistaminikov (glejte poglavje 4.2).
BESPONSA is for single use only. 
Zdravilo BESPONSA je samo za enkratno uporabo.
The most common (≥ 20%) adverse reactions were thrombocytopenia (51%), neutropenia (49%), infection (48%), anaemia (36%), leukopenia (35%), fatigue (35%), haemorrhage (33%), pyrexia (32%), nausea (31%), headache (28%), febrile neutropenia (26%), increased transaminases (26%), abdominal pain (23%), increased gamma-glutamyltransferase (21%), and hyperbilirubinaemia (21%). 
Najpogostejši (≥ 20 %) neželeni učinki so bili trombocitopenija (51 %), nevtropenija (49 %), okužba (48 %), anemija (36 %), levkopenija (35 %), utrujenost (35 %), krvavitev (33 %), pireksija (32 %), navzea (31 %), glavobol (28 %), febrilna nevtropenija (26 %), zvečanje vrednosti transaminaz (26 %),
In addition, inotuzumab ozogamicin and N-acetyl-gamma-calicheamicin dimethylhydrazide are unlikely to alter the exposure of substrates of CYP enzymes, and N-acetyl-gamma-calicheamicin dimethylhydrazide is unlikely to alter the exposure of substrates of UGT enzymes or major drug transporters. 
Prav tako ni verjetno, da bi inotuzumab ozogamicin in N-acetil-gama-kaliheamicin dimetilhidrazid spremenila izpostavljenost substratov encimov CYP in da bi N-acetil-gama-kaliheamicin dimetilhidrazid spremenil izpostavljenost substratov encimov UGT ali pomembnih prenašalcev zdravil.
Diluted solution After start of dilution 
Razredčena raztopina po začetku redčenja uporaba
One Grade 5 bleeding/haemorrhagic event (intra-abdominal haemorrhage) was reported. 
Poročali so o eni krvavitvi stopnje 5 (intraabdominalna krvavitev).
The frequencies of specific infections were: sepsis and bacteraemia (17%), lower respiratory tract infection (12%), upper respiratory tract infection (12%), fungal infection (9%), viral infection (7%), gastrointestinal infection (4%), skin infection (4%), and bacterial infection (1%). 
Pogostnosti določenih vrst okužb so bile: sepsa in bakteriemija (17 %), okužba spodnjih dihal (12 %), okužba zgornjih dihal (12 %), glivična okužba (9 %), virusna okužba (7 %), okužba prebavil (4 %), okužba kože (4 %) in bakterijska okužba (1 %).
For periodic monitoring of ECG and electrolyte levels, see section 4.4. 
Za redno spremljanje vrednosti EKG in elektrolitov glejte poglavje 4.4.
Abbreviations: ALL=acute lymphoblastic leukaemia; ANC=absolute neutrophil counts; Ara-C=cytarabine; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete haematological recovery; DoR=duration of remission; EAC=Endpoint Adjudication Committee; FLAG=fludarabine + cytarabine + granulocyte colony-stimulating factor; HIDAC=high dose cytarabine; HSCT=haematopoietic stem cell transplant; ITT=intent-to-treat; MRD=minimal residual disease; MXN=mitoxantrone; N/n=number of patients; OS=overall survival; PFS=progression-free survival. 
Okrajšave: ALL = akutna limfoblastna levkemija; ANC = absolutno število nevtrofilcev; Ara-C = citarabin; IZ = interval zaupanja; CR = popolna remisija; CRi = popolna remisija z delnim hematološkim okrevanjem; DoR = trajanje remisije; EAC = Odbor za presojo opazovanih dogodkov; FLAG = fludarabin + citarabin + granulocitne kolonije stimulirajoči faktor; HiDAC = veliki odmerki citarabina; PKMC = presaditev krvotvornih matičnih celic; ITT = populacija, ki so jo nameravali zdraviti (Intent-To-Treat); MRD = minimalna rezidualna bolezen; MXN = mitoksantron; n = število bolnikov; OS = celokupno preživetje; PFS = preživetje brez napredovanja bolezni.
As appropriate, prophylactic anti-infectives should be administered and surveillance testing should be employed during and after treatment. 
Med zdravljenjem in po njem je treba po potrebi uporabiti profilaktična zdravila za zdravljenje okužb in izvajati preiskave za spremljanje bolnikov.
Each vial contains 1 mg inotuzumab ozogamicin. 
Ena viala vsebuje 1 mg inotuzumab ozogamicina.
Venoocclusive disease may be fatal and is associated with rapid weight gain, pain in the upper right side of your abdomen (belly), increase in the size of the liver, build-up of fluid causing abdominal swelling, and blood tests showing increases in bilirubin and/or liver enzymes (that may result in yellowing of the skin or eyes). 
Venookluzivna bolezen jeter je lahko smrtna in je povezana s hitrim zvečanjem telesne mase, bolečino v zgornjem desnem predelu trebuha, zvečanjem velikosti jeter, kopičenjem tekočine, kar povzroča otekanje trebuha, in izvidi krvnih preiskav, ki kažejo na zvečanje vrednosti bilirubina in/ali jetrnih encimov (kar lahko povzroči rumenkasto obarvanje kože ali oči).
Based on non-clinical findings, male and female fertility may be compromised by treatment with inotuzumab ozogamicin (see section 5.3). 
Na podlagi nekliničnih ugotovitev lahko zdravljenje z inotuzumab ozogamicinom ogrozi plodnost pri moških in ženskah (glejte poglavje 5.3).
Injury, poisoning and procedural complications 
Poškodbe in zastrupitve in zapleti pri posegih z infuzijo povezana reakcija
BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22positive B cell precursor acute lymphoblastic leukaemia (ALL). 
Zdravilo BESPONSA je indicirano kot monoterapija za zdravljenje odraslih z recidivno ali refraktarno prekurzorsko B-celično akutno limfoblastno levkemijo (ALL), pozitivno na CD22.
Alternatively, CD22 expression was assessed using immunohistochemistry in patients with an inadequate bone marrow aspirate and insufficient circulating blasts. 
Druga možnost je bila, da so izraženost CD22 pri bolnikih z nezadostnim aspiratom kostnega mozga in nezadostnimi blasti v obtoku ocenjevali imunohistokemijsko.
Nonclinical data suggest that the anticancer activity of BESPONSA is due to the binding of the ADC to CD22-expressing tumour cells, followed by internalisation of the ADC-CD22 complex, and the intracellular release of N-acetyl-gamma-calicheamicin dimethylhydrazide via hydrolytic cleavage of the linker. 
Neklinični podatki kažejo, da zdravilo BESPONSA deluje proti rakavim obolenjem zaradi vezave ADC na tumorske celice z izraženim CD22, čemur sledi internalizacija kompleksa ADC-CD22, in znotrajcelično sproščanje N-acetil-gama-kaliheamicin dimetilhidrazida preko hidrolitske cepitve povezovalca.
2-sided p-value < 0.0001 BESPONSA (N=164) 
2-stranska vrednost p < 0,0001 Zdravilo BESPONSA (n = 164)
In those patients who proceeded directly to HSCT, there was a median gap of 4.8 weeks (range: 1-19 weeks) between the last dose of inotuzumab ozogamicin and HSCT. 
Pri bolnikih, ki so nadaljevali neposredno na PKMC, je bil mediani razmik od zadnjega odmerka inotuzumab ozogamicina do PKMC 4,8 tednov (razpon: 1-19 tednov).
Infusion related reaction 
z infuzijo povezana reakcija
Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA (see section 4.2). 
Zvečanje vrednosti jetrnih testov lahko zahteva prekinitev odmerjanja, zmanjšanje odmerka ali trajno prekinitev zdravljenja z zdravilom BESPONSA (glejte poglavje 4.2).
Infusion lines made of PVC (DEHP or non-DEHP-containing), polyolefin (polypropylene and/or polyethylene), or polybutadiene are recommended. 
Priporočljivi so infuzijski sistemi, izdelani iz PVC (ki vsebujejo ali ne vsebujejo DEHP), poliolefina (polipropilena in/ali polietilena) ali polibutadiena.