natgillin/translations-raw huggingface dataset:
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.
V randomiziranem kliničnem preskušanju pri bolnikih z recidivno ali refraktarno ALL (Študija 1) so največja podaljšanja intervala QTcF za  30 ms in ≥ 60 ms glede na izhodišče izmerili pri 30/162 (19 %) in 4/162 (3 %) bolnikov v skupini z inotuzumab ozogamicinom, v primerjavi z 18/124 (15 %) oziroma 3/124 (2 %) bolnikov v skupini s kemoterapijo po izbiri raziskovalca.
In the Phase 1 portion of the study, 37 patients received BESPONSA at a total dose of 1.2 mg/m2 (n=3), 1.6 mg/m2 (n=12), or 1.8 mg/m2 (n=22).
V 1. fazi študije je 37 bolnikov prejelo zdravilo BESPONSA v skupnem odmerku 1,2 mg/m 2 (n = 3),
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).
Zdravljenje trajno prekinite, če se celokupni bilirubin ne vrne na ≤ 1,5 × ZMN ali če se AST/ALT ne vrne na ≤ 2,5 × ZMN (glejte poglavje 4.4).
Interrupt dosing until recovery of total bilirubin to ≤ 1.5 × ULN and AST/ALT to ≤ 2.5 × ULN prior to each dose unless due to Gilbert's syndrome or haemolysis.
Odmerjanje prekinite, dokler se vrednost celokupnega bilirubina ne vrne na ≤ 1,5 × ZMN ali vrednost AST/ALT na ≤ 2,5 × ZMN pred vsakim odmerkom, razen v primeru Gilbertovega sindroma ali hemolize.
ANC was < 1 × 109/L and/or platelet count was < 50 × 109/La
9/l in/ali število trombocitov < 50 × 10
Grade ≥ 2a non-haematological toxicity (BESPONSA-related)
Prilagoditev(-e) odmerka nehematološka toksičnost stopnje ≥ 2
The frequencies of specific bleeding/haemorrhagic events were: epistaxis (15%), upper gastrointestinal haemorrhage (6%), lower gastrointestinal haemorrhage (4%), and central nervous system (CNS) haemorrhage (1%).
Pogostnosti določenih vrst krvavitev so bile: epistaksa (15 %), krvavitev v zgornjih prebavilih (6 %), krvavitev v spodnjih prebavilih (4 %) in krvavitev v centralnem živčnem sistemu (CŽS) (1 %).
For clinical management of infusion related reactions, see section 4.4.
Za klinično obvladovanje z infuzijo povezanih reakcij glejte poglavje 4.4.
Based on non-clinical safety findings, inotuzumab ozogamicin can cause embryo-foetal harm when administered to a pregnant woman.
Podatkov o uporabi inotuzumab ozogamicina pri nosečnicah ni. Na podlagi nekliničnih ugotovitev glede varnosti lahko inotuzumab ozogamicin škoduje zarodku/plodu, če ga uporabljamo pri nosečnicah.
Eligible patients were ≥ 18 years of age with relapsed or refractory B-cell precursor ALL.
Za vključitev v raziskavo so bili primerni bolniki, stari ≥ 18 let, z recidivno ali refraktarno prekurzorsko B-celično ALL.
Patients with relapsed or refractory ALL who have received 1 or 2 prior treatment regimens for ALL - Study 1
Bolniki z recidivno ali refraktarno ALL, ki so za ALL prejeli 1 ali 2 predhodna režima zdravljenjaŠtudija 1
Maximum time from reconstitution through the end of administration ≤ 8 hoursa Reconstituted solution
Najdaljši čas od rekonstitucije do konca uporabe ≤ 8 ur
Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing (see section 4.2).
Pred odmerjanjem je priporočljiva premedikacija s kortikosteroidom, antipiretikom in antihistaminikom (glejte poglavje 4.2).
Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing (see section 4.4).
Pred odmerjanjem je priporočljiva premedikacija s kortikosteroidom, antipiretikom in antihistaminikom (glejte poglavje 4.4).
• Pain in the abdomen
• bolečine v trebuhu
Women of childbearing potential should avoid becoming pregnant while receiving BESPONSA.
Ženske v rodni dobi se morajo med zdravljenjem z zdravilom BESPONSA izogibati zanositvi.
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).
Na podlagi nekliničnih ugotovitev velja, da lahko inotuzumab ozogamicin potencialno oslabi sposobnost razmnoževanja in plodnost pri moških in ženskah (glejte poglavje 4.6).
incomplete recovery of peripheral blood counts (platelets < 100 × 109/L and/or ANC < 1 × 109/L) and resolution of any extramedullary disease.
9/l in/ali ANC < 1 × 10 9/l) ter izboljšanje stanja katerekoli ekstramedularne bolezni.
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).
Sindrom tumorske lize je povezan z različnimi simptomi v trebuhu in črevesju (na primer občutek siljenja na bruhanje, bruhanje, driska), srčnimi simptomi (na primer spremembe ritma), ledvičnimi simptomi (na primer zmanjšana količina urina, kri v urinu) ter živčnimi in mišičnimi simptomi (na primer bolečine v mišicah, oslabelost, krči).
There was also a trend for better OS with BESPONSA for patients with other prognostic factors (Ph-, no prior HSCT, ≥ 90% leukaemic blasts CD22-positive at baseline, no baseline peripheral blasts, and baseline haemoglobin ≥ 10 g/dL, based on exploratory analyses).
-, brez predhodne PKMC,  90 % levkemičnih blastov, pozitivni na CD22 ob izhodišču, brez blastov v periferni krvi ob izhodišču in izhodiščni hemoglobin ≥ 10 g/dl glede na raziskovalne analize).
The recommended BESPONSA dose was determined to be 1.8 mg/m2/cycle administered at a dose of 0.8 mg/m2 on Day 1 and 0.5 mg/m2 on Days 8 and 15 of a 28-day cycle with a dose reduction upon achieving CR/CRi.
Priporočeni odmerek zdravila BESPONSA, ki so ga določili, je bil 1,8 mg/m 2/cikel, dan v odmerku 0,8 mg/m 2 na 1. dan in 0,5 mg/m 2 na 8. in 15. dan
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).
Pri bolnikih z velikim tumorskim bremenom sta pred odmerjanjem priporočljivi premedikacija za znižanje ravni sečne kisline in hidracija (glejte poglavje 4.2).
• Infuse the diluted solution for 1 hour at a rate of 50 mL/h at room temperature (20 °C-25 °C).
• Razredčeno raztopino infundirajte 1 uro pri sobni temperaturi (20 °C - 25 °C) s hitrostjo 50 ml/h.
Pyrexia (32%) Fatigue (35%) Chills (11%)
Splošne težave in spremembe na mestu aplikacije pireksija (32 %) utrujenost (35 %) mrzlica (11 %)
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).
Zdravljenje trajno prekinite, če se vrednost celokupnega bilirubina ne vrne na ≤ 1,5 × ZMN ali če se vrednost AST/ALT ne vrne na ≤ 2,5 × ZMN (glejte preglednico 3 in poglavje 4.4).
Eligible patients were ≥ 18 years of age with Philadelphia chromosome negative (Ph-) or Ph+ relapsed or refractory B-cell CD22-positive precursor ALL.
Za vključitev so bili primerni bolniki, stari ≥ 18 let, z recidivno ali refraktarno prekurzorsko B-celično ALL, pozitivno na CD22, s prisotnim kromosomom Philadelphia (Ph
No formal pharmacokinetic studies of inotuzumab ozogamicin have been conducted in patients with renal impairment.
Formalnih farmakokinetičnih preskušanj z inotuzumab ozogamicinom pri bolnikih z okvaro ledvic niso izvedli.
No formal pharmacokinetic studies of inotuzumab ozogamicin have been conducted in patients with hepatic impairment.
Formalnih farmakokinetičnih preskušanj z inotuzumab ozogamicinom pri bolnikih z okvaro jeter niso izvedli.
Common Increased lipase (9%)
zvečanje vrednosti amilaze (5 %) zvečanje vrednosti lipaze (9 %)
c Haemorrhage also includes other types of haemorrhage (17%).
Krvavitev vključuje tudi druge vrste krvavitev (17 %).
Hyperbilirubinaemia (21%) Increased transaminases (26%) Increased GGT (21%)
Bolezni jeter, žolčnika in žolčevodov hiperbilirubinemija (21 %) zvečanje vrednosti transaminaz zvečanje vrednosti GGT (21 %)
• 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.
• imate znake ali simptome nizkega števila krvnih celic, imenovanih nevtrofilci (kar včasih spremlja vročina), rdečih krvnih celic, belih krvnih celic, limfocitov ali nizko število krvnih sestavin, imenovanih trombociti.
Use reconstituted solution immediately or after being stored in a refrigerator (2 °C-8 °C) for up to 4 hours.
Rekonstituirano raztopino uporabite takoj ali po tem, ko ste jo hranili v hladilniku (2 °C - 8 °C) največ 4 ure.
• 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.
• Če razredčeno raztopino hranite v hladilniku (2 °C - 8 °C), jo morate pred uporabo pustiti, da se 1 uro segreva na sobni temperaturi (20 °C - 25 °C).
• 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).
• sindrom tumorske lize (glejte poglavje 2); to je lahko povezano z vrsto simptomov v trebuhu in črevesju (na primer občutek siljenja na bruhanje, bruhanje, driska), srčnimi simptomi (na primer spremembe ritma), ledvičnimi simptomi (na primer zmanjšana količina urina, kri v urinu) ter živčnimi in mišičnimi simptomi (na primer bolečine v mišicah, oslabelost, krči).
g Duration of remission was defined as the time since first response of CRa or CRib per Investigator's assessment to the date of a PFS event or censoring date if no PFS event was documented.
PFS ali datuma krnjenja, če niso zabeležili nobenega dogodka PFS.
For clinical management of TLS, see section 4.4.
Za klinično obvladovanje TLS glejte poglavje 4.4.
Treatment should be permanently discontinued if VOD/SOS occurs (see section 4.2).
Če se pojavi VOD/SOS, je treba zdravljenje trajno prekiniti (glejte poglavje 4.2).
After reconstitution, 1 mL of solution contains 0.25 mg inotuzumab ozogamicin.
Po rekonstituciji 1 ml raztopine vsebuje 0,25 mg inotuzumab ozogamicina.
• If the medicine works well, but you are not going to receive a stem cell transplant (see section
• Če zdravilo deluje dobro, vendar pri vas ne bodo opravili presaditve matičnih celic (glejte poglavje 2), lahko prejmete največ 6 ciklov zdravljenja.
Dose modifications for non-haematological toxicities at any time during treatment Non-haematological toxicity Dose modification(s)
Prilagoditve odmerkov za nehematološke toksičnosti kadarkoli med zdravljenjem
Hepatotoxicity, including severe, life-threatening, and sometimes fatal hepatic VOD/SOS, was reported in patients with relapsed or refractory ALL receiving BESPONSA (see section 4.8).
Pri bolnikih z recidivno ali refraktarno ALL, ki so prejemali zdravilo BESPONSA, so poročali o hepatotoksičnosti, vključno s hudo, življenjsko ogrožajočo in včasih smrtno VOD jeter/SOS (glejte poglavje 4.8).
Based on a population pharmacokinetic analysis in 765 patients, the clearance of inotuzumab ozogamicin in patients with hepatic impairment defined by National Cancer Institute Organ Dysfunction Working Group (NCI ODWG) category B1 (total bilirubin ≤ ULN and AST > ULN; n=133) or B2 (total bilirubin > 1.0-1.5 × ULN and AST any level; n=17) was similar to patients with normal hepatic function (total bilirubin/AST ≤ ULN; n=611) (see section 4.2).
in AST > ZMN; n = 133) ali B2 (celokupni bilirubin > 1,0-1,5 × ZMN in katerakoli vrednost AST; n = 17) delovne skupine Nacionalnega inštituta za rakava obolenja za področje motenj delovanja organov (NCI ODWG - National Cancer Institute Organ Dysfunction Working Group), podoben kot pri bolnikih z normalnim delovanjem jeter (celokupni bilirubin/AST ≤ ZMN; n = 611) (glejte poglavje 4.2).
Always use this medicine exactly as your doctor, pharmacist, or nurse has told you.
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre.
Administer diluted solution as a 1-hour infusion at a rate of 50 mL/h at room temperature (20 °C-25 °C).
Razredčeno raztopino infundirajte 1 uro pri sobni temperaturi (20 °C - 25 °C) s hitrostjo 50 ml/h.
Haemorrhagec (33%) (includes Central nervous system haemorrhage [1%], Upper gastrointestinal haemorrhage [6%], Lower gastrointestinal haemorrhage [4%], Epistaxis
Žilne bolezni krvavitev c (33 %) (vključuje krvavitev v centralnem živčnem sistemu [1 %], krvavitev v zgornjih prebavilih [6 %], krvavitev v spodnjih prebavilih [4 %], epistakso [15 %])
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).
Če se ANC in/ali število trombocitov zmanjšata, prekinite naslednji cikel zdravljenja, dokler se ne zgodi vsaj eno od naslednjega: - ANC in število trombocitov se vrneta vsaj na izhodiščni vrednosti predhodnega cikla ali - ANC se vrne na ≥ 1 × 10
In the pivotal clinical study (N=164), bleeding/haemorrhagic events, mostly mild in severity, were reported in 54/ (33%) patients.
V ključnem preskušanju (n = 164) so o krvavitvah, ki so bile večinoma blage, poročali pri 54 (33 %) bolnikih.
After reconstitution each vial contains 0.25 mg/mL of inotuzumab ozogamicin.
Po rekonstituciji ena viala vsebuje 0,25 mg/ml inotuzumab ozogamicina.
CRa; n (%) [95% CI]
CR a; n (%) [95 % IZ]
White to off-white, lyophilised cake or powder.
prašek za koncentrat za raztopino za infundiranje bela do belkasta liofilizirana pogača ali prašek
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,
Stopnjo je odbor EAC opredelil kot število bolnikov, ki so dosegli negativen izvid za MRD, deljeno s skupnim številom bolnikom, ki so dosegli CR/CRi.
• 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.
• imate med infundiranjem zdravila BESPONSA ali kmalu po njem znake in simptome sindroma tumorske lize, ki je lahko povezan s simptomi v trebuhu in črevesju (na primer občutek siljenja na bruhanje, bruhanje, driska), srčnimi simptomi (na primer spremembe ritma), ledvičnimi simptomi (na primer zmanjšana količina urina, kri v urinu) ter živčnimi in mišičnimi simptomi (na primer bolečine v mišicah, oslabelost, krči).
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).
Pri bolnikih, ki so prejemali inotuzumab ozogamicin, so pri nekaterih bolnikih poročali o zapletih, povezanih z nevtropenijo oziroma trombocitopenijo (vključno z okužbami oziroma krvavitvami) (glejte poglavje 4.8).
Abbreviations: ALL=acute lymphoblastic leukaemia; ANC=absolute neutrophil counts; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete haematological recovery; DoR=duration of remission; HSCT=haematopoietic stem cell transplant; MRD=minimal residual disease; N/n=number of patients; OS=overall survival; PFS=progression-free survival.
Okrajšave: ALL = akutna limfoblastna levkemija; ANC = absolutno število nevtrofilcev; IZ = interval zaupanja; CR = popolna remisija; CRi = popolna remisija z delnim hematološkim okrevanjem; DoR = trajanje remisije;
For clinical management of myelosuppression/cytopenias, see section 4.4.
Za klinično obvladovanje mielosupresije/citopenij glejte poglavje 4.4.
What BESPONSA contains
Kaj vsebuje zdravilo BESPONSA
• Mouth inflammation
• otekanje trebuha
Platelet count was ≥ 50 × 109/La
število trombocitov ≥ 50 × 10
• have previously had severe venoocclusive disease (a condition in which the blood vessels in the liver become damaged and blocked by blood clots) which was confirmed or have ongoing venoocclusive disease.
• ste v preteklosti imeli potrjeno ali imate trenutno venookluzivno bolezen jeter (stanje, pri katerem krvni strdki poškodujejo in zamašijo žile v jetrih).
• The diluted solution must be used immediately, stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
• Razredčeno raztopino je treba uporabiti takoj oziroma hraniti pri sobni temperaturi (20 °C25 °C) ali v hladilniku (2 °C - 8 °C).
28 dayse
28 dni
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).
Pred odmerjanjem sta pri bolnikih z velikim tumorskim bremenom priporočljivi premedikacija za znižanje ravni sečne kisline in hidracija (glejte poglavje 4.4).
How to store BESPONSA
Rekonstituirana raztopina
Patients with mixed-lineage leukaemia (MLL) gene rearrangements, including t (4;11), that generally have lower
Bolniki s preureditvami gena levkemije mešane celične linije (MLL - Mixed-Lineage Leukaemia), vključno s t(4;11), ki imajo pred zdravljenjem običajno nižjo izraženost CD22, so imeli po zdravljenju z zdravilom BESPONSA ali kemoterapiji po izbiri raziskovalca slabši izid OS.
The diluted solution must be used immediately or stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
Razredčeno raztopino je treba uporabiti takoj oziroma hraniti pri sobni temperaturi (20 °C - 25 °C) ali v hladilniku (2 °C - 8 °C).
The benefit/risk should be carefully considered before administering BESPONSA to patients in whom the future use of HSCT conditioning regimens containing 2 alkylating agents is likely unavoidable.
Pri bolnikih, pri katerih je v prihodnosti verjetno neizogibna uporaba pripravljalnih shem za PKMC, ki vključujejo 2 alkilirajoča citostatika, je pred uporabo zdravila BESPONSA treba skrbno pretehtati razmerje med koristmi in tveganji.
Median PFSe, f; months [95% CI]
Mediano DoR f; meseci [95 % IZ]
CRib; n (%) [95% CI]
CRi b; n (%) [95 % IZ]
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).
V kliničnih preskušanjih pri bolnikih z recidivno ali refraktarno ALL so bili največji enkratni oziroma večkratni odmerki inotuzumab ozogamicina 0,8 mg/m 2 oziroma 1,8 mg/m 2 na cikel, ki so jih dajali kot
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.
Ženske morajo med zdravljenjem in vsaj 8 mesecev po zadnjem odmerku zdravila uporabljati učinkovito metodo kontracepcije.
CRa/CRib; n (%) [95% CI]
CR a/CRi b; n (%) [95 % IZ]
Inotuzumab ozogamicin has not been studied in patients with end-stage renal disease (see section 4.2).
Pri bolnikih s končno ledvično odpovedjo inotuzumab ozogamicina niso preučevali (glejte poglavje 4.2).
Use diluted solution immediately or after being stored at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
Razredčeno raztopino uporabite takoj ali po tem, ko ste jo hranili na sobni temperaturi (20 °C - 25 °C) ali v hladilniku (2 °C - 8 °C).
and/or vincristine to a peripheral blast count ≤ 10,000/mm3 is recommended prior to the first dose.
Pri bolnikih z limfoblasti v obtoku je pred prvim odmerkom priporočljiva citoredukcija s kombinacijo hidroksisečnine, steroidov in/ali vinkristina, in sicer do števila blastov v periferni krvi ≤ 10.000/mm
For subsequent cycles, the recommended total dose of BESPONSA is 1.5 mg/m2 per cycle given 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.
(0,5 mg/m 2) in 15. dan (0,5 mg/m 2), pri bolnikih, ki dosežejo CR/CRi, ali 1,8 mg/m 2 na cikel, ki ga dajemo v 3 deljenih odmerkih 1.
Increased alkaline phosphatase
Preiskave zvečanje vrednosti alkalne fosfataze (13 %)
SN:
IZ]
Potential hepatobiliary disease should be evaluated and treated according to standard medical practice.
Bolnike je treba spremljati glede zvečanih vrednosti amilaze in lipaze, ocenjevati možnost za bolezni jeter, žolčnika in žolčevodov in jih zdraviti v skladu z običajno medicinsko prakso.
Median PFSe; months [95% CI]
Mediano OS; meseci [95 % IZ]
Special populations Elderly
Posebne skupine bolnikov
The active ingredient in BESPONSA is inotuzumab ozogamicin.
Učinkovina v zdravilu BESPONSA je inotuzumab ozogamicin.
a CR, per EAC, was 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.
CR je odbor EAC opredelil kot < 5 % blastov v kostnem mozgu in odsotnost levkemičnih blastov v periferni krvi, popolno izboljšanje periferne krvne slike (trombociti ≥ 100 × 10
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.
CR je opredeljen kot < 5 % blastov v kostnem mozgu in odsotnost levkemičnih blastov v periferni krvi, popolno izboljšanje periferne krvne slike (trombociti ≥ 100 × 10
Median OS; months [95% CI]
; meseci [95 % IZ]
4 hours between reconstitution and dilution.
Čas med rekonstitucijo in redčenjem mora biti ≤ 4 ure.
Median DoRg; months [95% CI]
Mediano DoR g; meseci [95 % IZ]
The OS improvement for BESPONSA versus Investigator's choice of chemotherapy arm was seen in patients who underwent HSCT.
Pri bolnikih, ki so jim opravili PKMC, so opazili izboljšanje OS za zdravilo BESPONSA v primerjavi s skupino s kemoterapijo po izbiri raziskovalca.
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.
CRi je odbor EAC opredelil kot < 5 % blastov v kostnem mozgu in odsotnost levkemičnih blastov v periferni krvi, delno izboljšanje periferne krvne slike (trombociti < 100 × 10
Dose (mg/m2)
(0,8 mg/m
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).
Pri prvem ciklu je priporočeni celokupni odmerek zdravila BESPONSA za vse bolnike 1,8 mg/m 2 na cikel, ki ga dajemo v 3 deljenih odmerkih 1.
Women should use effective contraception during treatment with BESPONSA and for at least
Ženske morajo med zdravljenjem z zdravilom BESPONSA in vsaj 8 mesecev po zadnjem odmerku uporabljati učinkovito metodo kontracepcije.
Careful consideration is required before administering BESPONSA to patients who have had a prior HSCT.
Pri bolnikih s predhodnim PKMC je pred dajanjem zdravila BESPONSA potreben skrben razmislek.
These will require specific and sometimes preventive treatment.
Te zahtevajo specifično in včasih preventivno zdravljenje.