natgillin/translations-raw huggingface dataset:
In the clinical study, the sensitivity of some local tests was lower than the central laboratory test.
V kliničnem preskušanju je bila občutljivost nekaterih lokalnih preskusov manjša kot občutljivost preskusa centralnega laboratorija, zato je treba uporabljati samo validirane preskuse z dokazano veliko občutljivostjo.
During treatment, especially in the first few days after starting treatment, you may have raised liver enzymes.
Med zdravljenjem in zlasti v prvih nekaj dneh po začetku zdravljenja imate lahko zvečane vrednosti jetrnih encimov.
If particles or discolouration are observed, do not use.
Če opazite delce ali obarvanost, je ne uporabite.
Withdraw this amount from the vial(s) using a syringe.
Z brizgo izvlecite to količino iz vial(e).
During treatment, especially in the first few days after starting treatment, your white blood cell count may be severely lowered (neutropenia), which may be accompanied by fever (febrile neutropenia).
Med zdravljenjem in zlasti v prvih nekaj dneh po začetku zdravljenja se vam lahko število belih krvnih celic močno zmanjša (nevtropenija), kar lahko spremlja vročina (febrilna nevtropenija).
These may include corticosteroids (e.g., dexamethasone), antipyretics (medicines to reduce fever), and antihistamines (medicines to reduce allergic reactions).
Ta zdravila lahko vključujejo kortikosteroide (npr. deksametazon), antipiretike (zdravila za zniževanje vročine) in antihistaminike (zdravila za zmanjševanje alergijskih reakcij).
In animals, the primary target organs included the liver, bone marrow and lymphoid organs with associated haematological changes, kidney, and nervous system.
Pri živalih so primarni tarčni organi vključevali jetra, kostni mozeg in limfatične organe s povezanimi hematološkimi spremembami, ledvice in živčni sistem.
For patients who develop abnormal liver tests, liver tests and clinical signs and symptoms of hepatotoxicity should be monitored more frequently.
Pri bolnikih, pri katerih pride do nenormalnih vrednosti jetrnih testov, je treba jetrne teste in klinične znake ter simptome hepatotoksičnosti spremljati pogosteje.
BESPONSA must not be used during pregnancy unless the potential benefit to the mother outweighs the potential risks to the foetus.
Zdravila BESPONSA se ne sme uporabljati med nosečnostjo, razen če morebitna korist za mater odtehta morebitna tveganja za plod.
The European Medicines Agency has deferred the obligation to submit the results of studies with BESPONSA in 1 or more subsets of the paediatric population for the treatment of relapsed or refractory ALL (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom BESPONSA za 1 ali več podskupin pediatrične populacije za zdravljenje recidivne ali refraktarne ALL (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
This belongs to a group of medicines that target cancer cells.
Sodi v skupino zdravil, ki so usmerjena proti rakavim celicam.
The table below shows the recommended dosing regimens.
Spodnja preglednica prikazuje priporočene režime odmerjanja.
This risk was most marked in patients who underwent subsequent HSCT.
To tveganje je bilo najizrazitejše pri bolnikih, pri katerih so v nadaljevanju opravili PKMC.
The co-primary endpoints were CR/CRi, assessed by a blinded independent endpoint adjudication committee (EAC), and overall survival (OS).
Sočasna primarna opazovana dogodka sta bila CR/CRi, ki ju je ocenjeval neodvisni slepljeni Odbor za presojo opazovanih dogodkov (EAC - Endpoint Adjudication Committee), in celokupno preživetje (OS - Overall Survival).
For patients who proceed to HSCT, liver tests should be monitored closely during the first month post-HSCT, then less frequently thereafter, according to standard medical practice.
Pri bolnikih, pri katerih bodo opravili PKMC, je treba v prvem mesecu po PKMC skrbno spremljati jetrne teste, nato pa manj pogosto v skladu z običajno medicinsko prakso.
Table 1 shows the recommended dosing regimens.
Preglednica 1 prikazuje priporočene režime odmerjanja.
BESPONSA improved OS versus Investigator's choice of chemotherapy for all stratification factors including duration of first remission ≥12 months, Salvage 1 status, and age at randomisation <55 years.
Zdravilo BESPONSA je v primerjavi s kemoterapijo po izbiri raziskovalca izboljšalo OS pri vseh stratifikacijskih dejavnikih, vključno s trajanjem prve remisije  12 mesecev, rešilnim statusom 1 in starostjo ob randomizaciji < 55 let.
Interrupt treatment until recovery to Grade 1 or pre-treatment grade levels prior to each dose.
Zdravljenje prekinite do izboljšanja na stopnjo 1 ali stopnjo pred zdravljenjem pred vsakim odmerkom.
If an infusion related reaction occurs, the infusion should be interrupted and appropriate medical management should be instituted.
Če se pojavi z infuzijo povezana reakcija, je treba infundiranje prekiniti in zagotoviti ustrezno medicinsko obravnavo.
The effects of BESPONSA in pregnant women are not known, but based on its mechanism of action BESPONSA may harm your unborn baby.
Učinki zdravila BESPONSA na nosečnice niso znani, vendar lahko zdravilo BESPONSA glede na svoj mehanizem delovanja škoduje vašemu nerojenemu otroku.
The median time to onset of hyperbilirubinaemia and increased transaminases was 73 days and 29 days, respectively.
Mediani čas do pojava hiperbilirubinemije in zvečanja vrednosti transaminaz je bil 73 dni oziroma 29 dni.
Signs may include elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites.
Znaki lahko vključujejo zvečanje celokupnega bilirubina, hepatomegalijo (ki je lahko boleča), hitro zvečanje telesne mase in ascites.
Among all 326 randomised patients (ITT population), 215 (66%) patients had received 1 prior treatment regimen and 108 (33%) patients had received 2 prior treatment regimens for ALL.
Od vseh 326 randomiziranih bolnikov (populacija ITT) je 215 (66 %) bolnikov prejelo 1 predhodni režim zdravljenja, 108 (33 %) bolnikov pa je prejelo 2 predhodna režima zdravljenja za ALL.
Contact your doctor immediately if you or your partner becomes pregnant during the period of treatment with this medicine.
Nemudoma obvestite zdravnika, če med zdravljenjem s tem zdravilom vi ali vaša partnerka zanosite.
In patients with an inadequate bone marrow aspirate sample, a peripheral blood sample was tested.
Pri bolnikih z nezadostnim vzorcem aspirata kostnega mozga so testirali vzorec periferne krvi.
Patients should be monitored closely during and for at least 1 hour after the end of infusion for the potential onset of infusion related reactions, including symptoms such as hypotension, hot flush, or breathing problems.
Bolnike je treba med infundiranjem in najmanj 1 uro po koncu infundiranja skrbno spremljati glede morebitnega pojava z infuzijo povezanih reakcij, vključno s simptomi, kot so hipotenzija, vročinski oblivi ali težave z dihanjem.
Total bilirubin > 1.5 × ULN and AST/ALT > 2.5 × ULN
celokupni bilirubin > 1,5 × ZMN in AST/ALT > 2,5 × ZMN
• Reduced number of red blood cells which may result in fatigue and shortness of breath
• zmanjšano število rdečih krvnih celic, kar lahko povzroči utrujenost in kratko sapo
Of 93 screened patients, 72 patients were assigned to study drug and treated with BESPONSA.
Od 93 pregledanih bolnikov so jih 72 dodelili na in zdravili s preučevanim zdravilom BESPONSA.
progressive disease (including objective progression, relapse from CR/CRi, treatment discontinuation due to global deterioration of health status), and start of new induction therapy or post-therapy HSCT without achieving CR/CRi.
napredovala bolezen (vključno z objektivnim napredovanjem, ponovitvijo bolezni od CR/CRi, prekinitvijo zdravljenja zaradi splošnega poslabšanja zdravstvenega stanja) in začetek novega indukcijskega zdravljenja ali PKMC po zdravljenju brez dosežene CR/CRi.
Other observed changes included male and female reproductive organ effects (see below) and preneoplastic and neoplastic liver lesions
Druge opažene spremembe so vključevale učinke na moške in ženske reprodukcijske organe (glejte spodaj) in preneoplastične in neoplastične lezije v jetrih (glejte spodaj).
Men and women should seek advice regarding fertility preservation before treatment.
Moški in ženske se morajo pred zdravljenjem posvetovati glede ohranjanja plodnosti.
BESPONSA is intended for the treatment of acute lymphoblastic leukaemia for adult patients who have previously tried other treatments and for whom those treatments have failed.
Zdravilo BESPONSA uporabljamo za zdravljenje akutne limfoblastne levkemije pri odraslih bolnikih, ki so predhodno že preskusili druga zdravljenja in so bila ta neuspešna.
Dosing regimen for Cycle 1 and subsequent cycles depending on response to treatment
Režim odmerjanja za 1. cikel in naslednje cikle glede na odziv na zdravljenje
Baseline characteristics were similar in the initial 218 patients randomised.
Osnovne značilnosti so bile podobne pri vseh začetnih 218 randomiziranih bolnikih.
The safety and efficacy of BESPONSA were evaluated in a single-arm, open-label, multicentre Phase 1/2 study (Study 2).
Varnost in učinkovitost zdravila BESPONSA so ocenili v odprti, multicentrični študiji 1./2.
Although there was a higher frequency of early deaths post-HSCT (at Day 100) in the BESPONSA arm, there was evidence of a late survival benefit for BESPONSA.
Čeprav je bila pogostnost zgodnjih smrti po PKMC (100. dan) večja v skupini z zdravilom BESPONSA, so za zdravilo BESPONSA obstajali dokazi o poznejšem izboljšanju preživetja.
What you need to know before you are given BESPONSA
Kaj morate vedeti, preden boste prejeli zdravilo BESPONSA
No formal clinical drug interaction studies have been performed (see section 5.2).
Formalnih kliničnih preskušanj medsebojnega delovanja niso izvedli (glejte poglavje 5.2).
• If the medicine works well and you are going to receive a stem cell transplant (see section 2),
• Če zdravilo deluje dobro in bodo pri vas opravili presaditev matičnih celic (glejte poglavje 2),
Note: patients may have had > 1 type of haemorrhage.
Opomba: bolniki so lahko imeli > 1 vrsto krvavitve.
All patients were required to have ≥ 5% bone marrow blasts and to have received 1 or 2 prior induction chemotherapy regimens for ALL.
Zahtevali so, da morajo vsi bolniki imeti ≥ 5 % blastov v kostnem mozgu in so za ALL prejeli 1 ali 2 predhodna režima indukcijske kemoterapije.
Interrupt the next dose (maintain a minimum of 6 days between doses).
Prekinite naslednji odmerek (med odmerki mora miniti vsaj 6 dni).
• Reduced number of lymphocytes (a type of white blood cells) which may result in a tendency to develop infections
• zmanjšano število limfocitov (vrsta belih krvnih celic), kar lahko povzroči nagnjenost k razvoju okužb
• 1 glass vial containing a white to off-white lyophilised cake or powder.
• 1 stekleno vialo, ki vsebuje belo do belkasto liofilizirano pogačo ali prašek.
Before your treatment with BESPONSA, you will be given other medicines (pre-medications) to help reduce infusion reactions and other possible side effects.
Pred zdravljenjem z zdravilom BESPONSA boste prejeli druga zdravila (premedikacija), ki bodo pomagala zmanjšati z infuzijo povezane reakcije in druge morebitne neželene učinke.
Tell your doctor, pharmacist or nurse immediately if you became pregnant during the period of treatment with BESPONSA and for up to 8 months after finishing treatment.
Nemudoma obvestite zdravnika, farmacevta ali medicinsko sestro, če med zdravljenjem z zdravilom BESPONSA in v času do 8 mesecev po koncu zdravljenja zanosite.
No adjustment to the starting dose is required based on age (see section 5.2).
Prilagajanje začetnega odmerka glede na starost ni potrebno (glejte poglavje 5.2).
BESPONSA (N=109)
Zdravilo BESPONSA (n = 109)
Dosing regimen for Cycle 1 All patients: Dose (mg/m2) Cycle length
Režim odmerjanja za 1. cikel Vsi bolniki: odmerek (mg/m dolžina cikla
In humans, the total volume of distribution of inotuzumab ozogamicin was approximately 12 L.
Celotni volumen porazdelitve inotuzumab ozogamicina je pri ljudeh znašal približno 12 l.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT OTHER
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
• The other ingredients are sucrose, polysorbate 80, sodium chloride, and tromethamine.
• Druge sestavine zdravila so saharoza, polisorbat 80, natrijev klorid in trometamol.
• High levels of liver enzymes (which can be indicators of liver injury) in the blood
• zvečane ravni jetrnih encimov (ki so lahko kazalniki poškodbe jeter) v krvi
In vitro, the binding of the N-acetyl-gamma-calicheamicin dimethylhydrazide to human plasma proteins is approximately 97%.
In vitro delež vezave N-acetil-gama-kaliheamicin dimetilhidrazida na človeške beljakovine v plazmi znaša približno 97 %.
• Reduced number of white blood cells which may result in general weakness and a tendency to develop infections
• zmanjšano število belih krvnih celic, kar lahko povzroči splošno oslabelost in nagnjenost k razvoju okužb
Toxicity and dose modification(s)
Toksičnost in prilagoditev(-e) odmerka
The median (upper bound of the 95% CI) for the change in QTcF at a supratherapeutic Cmax concentration was 3.87 msec (7.54 msec).
Mediana (zgornja meja 95 % IZ) za spremembo intervala QTcF pri supraterapevtski koncentraciji Cmax je bila 3,87 ms (7,54 ms).
Any patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment.
Vsi bolniki, ki v 3 ciklih ne dosežejo CR/CRi, morajo zdravljenje prekiniti.
CR/CRi and MRD negativity findings in the initial 218 randomised patients were consistent with those seen in all 326 randomised patients.
CR/CRi in negativni izvidi za MRD pri prvotnih 218 randomiziranih bolnikih so bili skladni s tistimi, ki so jih opazili pri vseh 326 randomiziranih bolnikih.
Febrile neutropenia, which may be life-threatening, was reported in 43 (26%) patients.
O febrilni nevtropeniji, ki je lahko življenjsko ogrožajoča, so poročali pri 43 (26 %) bolnikih.
Abbreviation: ANC=absolute neutrophil count.
Okrajšava: ANC = absolutno število nevtrofilcev.
Fatal infections, including pneumonia, neutropenic sepsis, sepsis, septic shock, and pseudomonal sepsis, were reported in 8 (5%) patients.
O smrtnih okužbah, vključno s pljučnico, nevtropenično sepso, sepso, septičnim šokom in sepso, ki jo povzroča bakterija Pseudomonas aeruginosa, so poročali pri 8 (5 %) bolnikih.
Inotuzumab ozogamicin pharmacokinetics were well characterised by a 2-compartment model with linear and time-dependent clearance components.
Za farmakokinetiko inotuzumab ozogamicina je bil zelo značilen dvoprostorni model z linearnimi in časovno odvisnimi komponentami očistka.
BESPONSA doses within a treatment cycle (i.e. Days 8 and/or 15) do not need to be interrupted due to neutropenia or thrombocytopenia, but dosing interruptions within a cycle are recommended for non-haematological toxicities.
Znotraj cikla zdravljenja (tj. 8. in/ali 15. dan) odmerjanja zdravila BESPONSA ni treba prekiniti zaradi nevtropenije ali trombocitopenije, vendar pa so prekinitve odmerjanja znotraj cikla priporočljive pri nehematološki toksičnosti.
The secondary endpoints included MRD negativity, duration of remission (DoR), HSCT rate, and progression-free survival (PFS).
Sekundarni opazovani dogodki so vključevali negativen izvid za MRD, trajanje remisije (DoR - Duration of Remission), stopnjo PKMC in preživetje brez napredovanja bolezni (PFS - Progression-Free Survival).
Vaccination with live viral vaccines is not recommended for at least 2 weeks prior to the start of BESPONSA treatment, during treatment, and until recovery of B lymphocytes following the last treatment cycle.
Cepljenje z živimi virusnimi cepivi ni priporočljivo najmanj 2 tedna pred zdravljenjem z zdravilom BESPONSA, med zdravljenjem z zdravilom in po zadnjem ciklu zdravljenja, dokler ne pride do porasta limfocitov B.
BESPONSA is used to treat adults with acute lymphoblastic leukaemia.
Zdravilo BESPONSA se uporablja za zdravljenje odraslih z akutno limfoblastno levkemijo.
HIDAC, FLAG, or MXN/Ara-C (N=109)
HiDAC, FLAG ali MXN/Ara-C (n = 109)
Treatment with BESPONSA may prolong QT interval (a change in electrical activity of the heart that can cause serious irregular heart rhythms).
Zdravljenje z zdravilom BESPONSA lahko podaljša interval QT (sprememba električne aktivnosti srca, kar lahko povzroči resno neredno bitje srca).
Table 2 and Table 3 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
Preglednica 2 oziroma 3 prikazuje smernice za prilagajanje odmerkov za hematološko oziroma nehematološko toksičnost.
For patient-reported outcomes, most functioning and symptom scores were in favour of BESPONSA compared to Investigator's choice of chemotherapy.
Pri izidih, o katerih so poročali bolniki, je bila večina rezultatov funkcionalnosti in simptomov v korist zdravilu BESPONSA v primerjavi s kemoterapijo po izbiri raziskovalca.
Table 4 shows the dose modification guidelines depending on the duration of dosing interruptions due to toxicity.
Preglednica 4 prikazuje smernice za prilagajanje odmerkov glede na trajanje prekinitev odmerjanja zaradi toksičnosti.
Before your treatment with BESPONSA, you may be given medicines and be hydrated to prevent tumour lysis syndrome from occurring.
Pred zdravljenjem z zdravilom BESPONSA boste morda prejeli zdravila in boste hidrirani za preprečevanje pojava sindroma tumorske lize.
Other medicines and BESPONSA
Druga zdravila in zdravilo BESPONSA
In humans, serum N-acetyl-gamma-calicheamicin dimethylhydrazide levels were typically below the limit of quantitation (50 pg/mL), but sporadic measurable levels of unconjugated calicheamicin up to 276 pg/mL occurred in some patients.
Pri ljudeh so bile serumske vrednosti N-acetil-gama-kaliheamicin dimetilhidrazida običajno pod mejo kvantifikacije (50 pg/ml), pri nekaterih bolnikih pa so se občasno pojavljale izmerljive ravni nekonjugiranega kaliheamicina do 276 pg/ml.
In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Za izboljšanje sledljivosti bioloških zdravil morata biti v bolnikovi kartoteki jasno dokumentirana (ali navedena) lastniško ime in številka serije prejetega zdravila.
Adverse reactions included treatment-emergent, all-causality events that commenced on, or after Cycle 1 Day 1 within 42 days after the last dose of BESPONSA, but prior to the start of a new anticancer treatment (including HSCT).
Neželeni učinki so vključevali dogodke iz vseh vzrokov, ki so se pojavili zaradi zdravljenja na 1. dan 1. cikla ali po njem v 42 dneh po zadnjem odmerku zdravila BESPONSA, vendar pred začetkom novega zdravljenja proti rakavemu obolenju (vključno s PKMC).
• Your doctor will decide on the correct dose.
• Pravi odmerek bo določil zdravnik.
Slight foetal growth retardation in rats also occurred at approximately 0.4 times the human clinical exposure based on AUC (see section 4.6).
Rahla upočasnitev rasti ploda pri podganah se je pojavila tudi pri približno 0,4-kratniku klinične izpostavljenosti pri ljudeh na podlagi vrednosti AUC (glejte poglavje 4.6).
The QT interval should be monitored in case of combinations of such medicinal products (see sections 4.4, 4.8, and 5.2).
V primeru kombinacij teh zdravil je treba spremljati interval QT (glejte poglavja 4.4, 4.8 in 5.2).
Among the 79 patients who proceeded to a subsequent HSCT (8 of whom received additional salvage therapy after treatment with BESPONSA before proceeding to HSCT), VOD/SOS was reported in 18 (23%) patients.
Izmed 79 bolnikov, pri katerih so opravili PKMC (8 od njih je po zdravljenju z zdravilom BESPONSA prejelo dodatno rešilno zdravljenje, preden so pri njih opravili PKMC), so o VOD/SOS poročali pri 18 (23 %) bolnikih.
2-sided p-value = 0.0022
2-stranska vrednost p = 0,0022
Among all 326 randomised patients, the survival probability at 24 months was 22.8% in the BESPONSA arm and 10% in the Investigator's choice of chemotherapy arm.
Med vsemi 326 randomiziranimi bolniki je bila verjetnost preživetja po 24 mesecih 22,8 % v skupini z zdravilom BESPONSA in 10 % v skupini s kemoterapijo po izbiri raziskovalca.
Infusion related reactions generally occurred in Cycle 1 and shortly after the end of the inotuzumab ozogamicin infusion and resolved spontaneously or with medical management.
Z infuzijo povezane reakcije so se običajno pojavile v 1. ciklu in kmalu po koncu infundiranja inotuzumab ozogamicina ter so izzvenele spontano ali z medicinsko obravnavo.
HIDAC, FLAG, or MXN/Ara-C (N=162)
HiDAC, FLAG ali MXN/Ara-C (n = 162)
The safety of immunisation with live viral vaccines during or following BESPONSA therapy has not been studied.
Varnosti imunizacije z živimi virusnimi cepivi med zdravljenjem ali po zdravljenju z zdravilom BESPONSA niso preučevali.
Management of severe infection, bleeding/haemorrhage and other effects of myelosuppression, including severe neutropenia or thrombocytopenia, may require a dosing interruption, dose reduction, or discontinuation of treatment (see section 4.2).
Obvladovanje hude okužbe, krvavitve in drugih učinkov mielosupresije, vključno s hudo nevtropenijo ali trombocitopenijo, lahko zahteva prekinitev odmerjanja, zmanjšanje odmerka ali prekinitev zdravljenja (glejte poglavje 4.2).
Based on a population pharmacokinetic analysis, age, race, and gender did not significantly affect inotuzumab ozogamicin disposition.
Glede na populacijsko farmakokinetično analizo starost, rasa in spol niso pomembno vplivali na odstranjevanje inotuzumab ozogamicina.
Inotuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody that specifically recognises human CD22.
Inotuzumab je humanizirano protitelo, imunoglobulin razreda G podtipa 4 (IgG4), ki specifično prepoznava humani CD22.
• Add the reconstituted solution to an infusion container with sodium chloride 9 mg/mL (0.9%) solution for injection, to a total nominal volume of 50 mL.
• Rekonstituirano raztopino dodajte v infuzijski vsebnik z 9 mg/ml (0,9 %) raztopino natrijevega klorida za injiciranje do skupnega nominalnega volumna 50 ml.
BESPONSA should be administered with caution in patients who have a history of, or predisposition to QT interval prolongation, who are taking medicinal products that are known to prolong QT interval (see section 4.5) and in patients with electrolyte disturbances.
Zdravilo BESPONSA je treba uporabljati previdno pri bolnikih, ki imajo podaljšanje intervala QT v anamnezi ali so nagnjeni k podaljšanju intervala QT, pri bolnikih, ki jemljejo zdravila, za katera je znano, da podaljšajo interval QT (glejte poglavje 4.5), ter pri bolnikih z motnjami elektrolitov.
Inotuzumab ozogamicin (which has a density of 1.02 g/mL at 20 °C/68 °F) is light sensitive and should be protected from ultraviolet light during reconstitution, dilution, and administration.
Inotuzumab ozogamicin (ki ima gostoto 1,02 g/ml pri 20 °C/68 °F) je občutljiv na svetlobo in ga je treba med rekonstitucijo, redčenjem in uporabo zaščititi pred ultravijolično svetlobo.
In 234 patients with relapsed or refractory ALL, the clearance of inotuzumab ozogamicin at steady state was 0.0333 L/h, and the terminal elimination half-life (t½) at the end of Cycle 4 was approximately 12.3 days.
Pri 234 bolnikih z recidivno ali refraktarno ALL je bil očistek inotuzumab ozogamicina v stanju dinamičnega ravnovesja 0,0333 l/h, končni razpolovni čas izločanja (t½) ob koncu 4. cikla pa je znašal približno 12,3 dneva.
Based on a population pharmacokinetic analysis in 765 patients, body surface area was found to significantly affect inotuzumab ozogamicin disposition.
S populacijsko farmakokinetično analizo pri 765 bolnikih so ugotovili, da telesna površina pomembno vpliva na odstranjevanje inotuzumab ozogamicina.
In the Phase 2 portion of the study, 8/35 (22.9%) patients had a follow-up HSCT.
V 2. fazi študije so 8/35 (22,9 %) bolnikom v nadaljevanju opravili PKMC.
By central and local laboratory tests, 231/253 (91.3%) patients and 130/253 (51.4%) patients, respectively, had ≥ 70% CD22-positive leukaemic blasts at baseline.
Rezultati preskusov centralnega oziroma lokalnega laboratorija kažejo, da je 231/253 (91,3 %) bolnikov oziroma 130/253 (51,4 %) bolnikov imelo ≥ 70% CD22-pozitivnih levkemičnih blastov ob izhodišču.