natgillin/translations-raw huggingface dataset:
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%).
Učestalosti specifičnih slučajeva krvarenja/hemoragije bile su: epistaksa (15%), krvarenje iz gornjeg dijela gastrointestinalnog sustava (6%), krvarenje iz donjeg dijela gastrointestinalnog sustava (4%) i krvarenje u središnjem živčanom sustavu (SŽS) [1%].
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%])
a (uključujući sepsu i bakterijemiju [17%], gljivičnu infekciju [9%], infekciju donjih dišnih putova [12%], infekciju gornjih dišnih putova [12%], bakterijsku infekciju [1%], virusnu infekciju [7%], gastrointestinalnu infekciju [4%], infekciju kože [4%])
BESPONSA 1 mg powder for concentrate for solution for infusion
BESPONSA 1 mg prašak za koncentrat za otopinu za infuziju
In patients receiving inotuzumab ozogamicin, TLS, which may be life-threatening or fatal, was reported (see section 4.8).
U bolesnika koji primaju inotuzumab ozogamicin prijavljen je TLS, koji može biti opasan po život ili imati smrtni ishod (vidjeti dio 4.8).
Grade 3 thrombocytopenia and neutropenia were reported in 23 (14%) and 33 (20%) patients, respectively.
Trombocitopenija i neutropenija 3. stupnja su bile zabilježene u 23 (14%), odnosno 33 (20%) bolesnika.
In the pivotal study (N=164), thrombocytopenia and neutropenia were reported in 83 (51%) and 81 (49%) patients, respectively.
U ključnom kliničkom ispitivanju (N=164) trombocitopenija i neutropenija su zabilježene u 83 (51%), odnosno 81 (49%) bolesnika.
BESPONSA acts by attaching to cells with a protein called CD22.
BESPONSA djeluje tako da se veže na stanice s bjelančevinom koja se zove CD22.
- Store in a refrigerator (2 °C-8 °C).
- Čuvati u hladnjaku (2°C - 8°C).
MRD negativityc for patients achieving CR/CRi; rated (%) [95% CI]
Negativni status MRD-a c u bolesnika koji postižu CR/CRi; stopa d (%) [95%
Day 8a
8. dan
For clinical management of infusion related reactions, see section 4.4.
Za kliničko zbrinjavanje reakcija povezanih s infuzijom vidjeti dio 4.4.
Study 2: Efficacy results in patients ≥ 18 years of age with relapsed or refractory B-cell precursor ALL who received 2 or more prior treatment regimens for ALL
Ispitivanje 2: Rezultati djelotvornosti u bolesnika od ≥ 18 godina s recidivirajućom ili refraktornom ALL prekursora B-limfocita, koji su prethodno primili 2 ili više režima liječenja za ALL
include a prior HSCT, age ≥ 55 years, a history of liver disease and/or hepatitis before treatment, later salvage lines, and a greater number of treatment cycles.
Ostali čimbenici vezani uz bolesnika za koje se čini da su povezani s povećanim rizikom od VOD/SOS-a nakon HSCT-a, uključuju već provedeni HSCT, dob ≥ 55 godina, povijest bolesti jetre i/ili hepatitisa prije liječenja, terapija spasa u kasnijoj liniji i veći broj ciklusa liječenja.
For severe or life-threatening infusion reactions, permanently discontinue treatment (see section 4.4).
U slučaju reakcija povezanih s infuzijom koje su ozbiljne ili opasne po život, trajno prekinuti liječenje (vidjeti dio 4.4).
Pyrexia (32%) Fatigue (35%) Chills (11%)
Vrućica (32%) Umor (35%) Zimica (11%)
Each vial contains 1 mg inotuzumab ozogamicin.
Jedna bočica sadrži 1 mg inotuzumab ozogamicina.
At month 24, the survival probability was 38.0% (95% CI: 27.4, 48.5) versus 35.5% (95% CI: 20.1, 51.3) for BESPONSA and Investigator's choice of chemotherapy, respectively.
U 24. mjesecu vjerojatnost preživljenja iznosila je 38,0% (95% CI: 27,4; 48,5) u skupini koja je primala lijek BESPONSA u odnosu na 35,5% (95% CI: 20,1; 51,3) u skupini koja je primala kemoterapiju po izboru ispitivača.
For patients not proceeding to HSCT, a maximum of 6 cycles, may be administered.
U bolesnika koji liječenje neće nastaviti sa HSCT-om, može se primijeniti do maksimalno 6 ciklusa.
BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22positive B cell precursor acute lymphoblastic leukaemia (ALL).
BESPONSA je indicirana kao monoterapija za liječenje odraslih osoba s recidivirajućom ili refraktornom CD22-pozitivnom akutnom limfoblastičnom leukemijom (ALL) prekursora B limfocita, te odraslih osoba s recidivirajućom ili refraktornom ALL prekursora B limfocita pozitivnom na Philadelphia kromosom (Ph
If platelet count decreases, interrupt the next cycle of treatment until platelet count recovers to ≥ 50 × 109/La.
Ako se broj trombocita smanjuje, prekinuti sljedeći ciklus liječenja do obnavljanja broja trombocita na ≥ 50 × 10
• Infuse the diluted solution for 1 hour at a rate of 50 mL/h at room temperature (20 °C-25 °C).
• Infundirajte razrijeđenu otopinu tijekom 1 sat brzinom od 50 ml/h na sobnoj temperaturi (20°C - 25°C).
ANC was < 1 × 109/L and/or platelet count was < 50 × 109/La
9/l i/ili broj trombocita je bio < 50 × 10 9/l
Baseline characteristics were similar in the initial 218 patients randomised.
Svih 218 randomiziranih bolesnika imalo je slične karakteristike u početku.
Dose modifications depending on duration of dosing interruption due to toxicity Duration of dosing interruption due to toxicity
Tablica 4. Prilagodbe doze ovisno o trajanju prekida doziranja zbog toksičnosti
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.
Prekinuti doziranje dok se ukupni bilirubin ne vrati na ≤ 1,5 × GGN i AST/ALT na ≤ 2,5 × GGN prije svake doze, osim ako je uzrok Gilbertov sindrom ili hemoliza.
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).
Premedikacija u svrhu smanjenja razina mokraćne kiseline i hidratacija preporučuju se prije doziranja u bolesnika s velikim tumorskim opterećenjem (vidjeti dio 4.2).
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).
U nekih bolesnika koji primaju inotuzumab ozogamicin prijavljene su komplikacije povezane s neutropenijom i trombocitopenijom (uključujući infekcije, odnosno slučajeve krvarenja/hemoragije) (vidjeti dio 4.8).
• BESPONSA contains no bacteriostatic preservatives.
• BESPONSA ne sadrži bakteriostatske konzervanse.
Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing (see section 4.4).
Premedikacija s kortikosteroidom, antipiretikom i antihistaminikom preporučuje se prije doziranja (vidjeti dio 4.4).
If the reconstituted solution cannot be used immediately, it may be stored for up to 4 hours in a refrigerator (2 °C-8 °C).
Ako se rekonstituirana otopina ne može odmah iskoristiti, može se čuvati najviše 4 sata u hladnjaku (2°C - 8°C).
For severe or life-threatening infusion reactions, treatment should be permanently discontinued (see section 4.2).
U slučaju reakcija povezanih s infuzijom koje su teške ili opasne po život, potrebno je trajno prekinuti liječenje (vidjeti dio 4.2).
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.
U randomiziranom kliničkom ispitivanju u bolesnika s recidivirajućom ili refraktornom ALL (Ispitivanje 1), najveća produljenja QTcF intervala od ≥ 30 ms i ≥ 60 ms od početne vrijednosti izmjerena su u 30/162 (19%) bolesnika odnosno 4/162 (3%) bolesnika u skupini koja je primala inotuzumab ozogamicin, naspram 18/124 (15%) odnosno 3/124 (2%) bolesnika u skupini s kemoterapijom po izboru ispitivača.
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]).
Sigurnost i djelotvornost lijeka BESPONSA u bolesnika s recidivirajućom ili refraktornom CD22pozitivnom ALL su ocijenjeni u otvorenom, međunarodnom, multicentričnom ispitivanju faze 3 (Ispitivanje 1) u kojem su bolesnici randomizirani kako bi primili lijek BESPONSA (N=164 [164 je primilo liječenje]) ili kemoterapiju po izboru ispitivača (N=162 [143 je primilo liječenje]), točnije fludarabin + citarabin
Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing (see section 4.2).
Premedikacija kortikosteroidom, antipiretikom i antihistaminikom se preporučuje prije doziranja (vidjeti dio 4.2).
Abbreviations: ANC=absolute neutrophil counts; CR=complete remission; CRi=complete remission with incomplete haematological recovery.
Skraćenice: ABN=apsolutni broj neutrofila; CR=potpuna remisija; CRi=potpuna remisija s nepotpunim oporavkom krvne slike.
For clinical management of infections, see section 4.4.
Za kliničko zbrinjavanje infekcija vidjeti dio 4.4.
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).
Trajno prekinuti liječenje ako se ukupni bilirubin ne vrati na ≤ 1,5 × GGN ili se AST/ALT ne vrati na ≤ 2,5 × GGN (vidjeti dio 4.4).
In the pivotal study (N=164), maximum increases in QT interval corrected for heart rate using the Fridericia formula (QTcF) ≥ 30 msec and ≥ 60 msec from baseline were measured in 30/162 (19%) and 4/162 (3%) patient, respectively.
QT interval corrected for heart rate using the Fridericia formula, QTcF) od ≥ 30 ms i ≥ 60 ms od početne vrijednosti, izmjerena su u 30/162 (19%),
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,
Stopa je definirana kao broj bolesnika koji su postigli negativni status MRD-a podijeljen s ukupnim brojem bolesnika koji su postigli CR/CRi prema EAC-u.
BESPONSA is a powder for concentrate for solution for infusion.
BESPONSA je prašak za koncentrat za otopinu za infuziju.
Study 1: Efficacy results in patients ≥ 18 years of age with relapsed or refractory B-cell precursor ALL who received 1 or 2 prior treatment regimens for ALL
Tablica 6. Ispitivanje 1: Rezultati djelotvornosti u bolesnika od ≥ 18 godina s recidivirajućom ili refraktornom ALL prekursora B-limfocita, koji su prethodno primili 1 ili 2 režima liječenja za ALL
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).
Trajno prekinuti liječenje ako se ukupni bilirubin ne vrati na ≤ 1,5 × GGN ili ako se AST/ALT ne vrati na ≤ 2,5 × GGN (vidjeti Tablicu 3 i dio 4.4).
N-acetyl-gamma-calicheamicin is covalently attached to the antibody via an acid-cleavable linker.
N-acetil-gama-kalikeamicin je kovalentno vezan na protutijelo preko poveznice koja hidrolizira u kiselom.
Your doctor will also monitor for signs and symptoms of tumour lysis syndrome after you receive BESPONSA.
Liječnik će Vas također pratiti na znakove i simptome sindroma lize tumora nakon što primite lijek BESPONSA.
For clinical management of bleeding/haemorrhagic events, see section 4.4.
Za kliničko zbrinjavanje slučajeva krvarenja/hemoragije vidjeti dio 4.4.
- Use immediately or store in a refrigerator (2 °C-8 °C) for up to 4 hours.
- Iskoristiti odmah ili čuvati u hladnjaku (2°C - 8°C) najviše 4 sata.
• Mouth inflammation
• Upala usne šupljine
ANC was ≥ 1 × 109/L
9/l i ABN ≥ 1 × 10
After reconstitution, 1 mL of solution contains 0.25 mg inotuzumab ozogamicin.
Nakon rekonstitucije, 1 ml otopine sadrži 0,25 mg inotuzumab ozogamicina.
MedDRA System organ class Very common
Klasifikacija organskih sustava prema MedDRA-i
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).
HSCT-a,  90% leukemijskih blasta CD22-pozitivno na početku, bez početnih perifernih blasta i početni hemoglobin ≥ 10 g/dl, na temelju eksploratornih analiza).
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).
National Cancer Institute Organ Dysfunction Working Group, NCI ODWG) kao kategorija B1 (ukupni bilirubin ≤ GGN i AST > GGN; n=133) ili B2 (ukupni bilirubin > 1,0-1,5 × GGN i AST s bilo kojom razinom; n=17), bio je sličan onom u bolesnika s normalnom funkcijom jetre (ukupni bilirubin/AST ≤ GGN; n=611) (vidjeti dio 4.2).
• 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 znakove i simptome sindroma lize tumora, koji može biti povezan sa simptomima u trbuhu i crijevima (na primjer, mučnina, povraćanje, proljev), srcu (na primjer, promjene u srčanom ritmu), bubregu (na primjer, smanjena količina mokraće, krv u mokraći) te živcima i mišićima (na primjer, mišićni spazmi, mišićna slabost, grčevi), tijekom ili ubrzo nakon infuzije lijeka BESPONSA.
If the diluted solution is stored in a refrigerator (2 °C-8 °C), bring it to room temperature (20 °C-25 °C) for approximately 1 hour prior to administration.
Ako se razrijeđena otopina čuvala u hladnjaku (2°C - 8°C), pustite je da dosegne sobnu temperaturu (20°C25°C) oko 1 sat prije primjene.
Of the 9 patients with Ph+ B-cell ALL, 1 patient had received 1 previous TKI and 1 patient had received no prior TKIs.
+ B-staničnim ALL-om, 1 bolesnik je primio 1 prethodan TKI i 1 nije prethodno primio TKI.
Interrupt the 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 disease or haemolysis.
Prije svake doze, prekinuti doziranje do vraćanja ukupnog bilirubina na ≤ 1,5 × GGN i AST/ALT na ≤ 2,5 × GGN, osim ako je uzrok Gilbertova bolest ili hemoliza.
In patients receiving inotuzumab ozogamicin, QT interval prolongation was observed (see sections 4.8 and 5.2).
Produljenje QT-intervala je primijećeno u bolesnika koji primaju inotuzumab ozogamicin (vidjeti dijelove 4.8 i 5.2).
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 lize tumora se povezuje s nizom različitih simptoma u trbuhu i crijevima (na primjer, mučnina, povraćanje, proljev), srcu (na primjer, promjene u srčanom ritmu), bubregu (na primjer, smanjena količina mokraće, krv u mokraći) te živcima i mišićima (na primjer, mišićni spazmi, mišićna slabost, grčevi).
• 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.
• Ako se razrijeđena otopina čuva u hladnjaku (2°C - 8°C), mora se ostaviti da dosegne sobnu temperaturu (20°C - 25°C) oko 1 sat prije primjene.
BESPONSA contains no bacteriostatic preservatives.
BESPONSA ne sadrži bakteriostatske konzervanse.
Hazard ratio [95% CI] = 0.450 [0.348-0.581] 2-sided p-value < 0.0001
[1,4 do 2,1] Omjer hazarda [95% CI] = 0,450 [0,348-0,581] p-vrijednost dvostranog testa < 0,0001
Lymphoblastic leukaemia cells have this protein.
Tu bjelančevinu imaju stanice limfoblastične leukemije.
No formal pharmacokinetic studies of inotuzumab ozogamicin have been conducted in patients with hepatic impairment.
Nisu provedena posebna farmakokinetička ispitivanja inotuzumab ozogamicina u bolesnika s oštećenjem jetre.
How to store BESPONSA
Kako čuvati lijek BESPONSA
• Pain in the abdomen
• Bol u trbuhu
incomplete recovery of peripheral blood counts (platelets < 100 × 109/L and/or ANC < 1 × 109/L) and resolution of any extramedullary disease.
9/l i/ili ABN < 1 x 10 9/l) i odsutnost bilo kakve ekstramedularne bolesti.
• 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 lize tumora (vidjeti dio 2); to može biti povezano s različitim simptomima u trbuhu i crijevima (npr. mučnina, povraćanje, proljev), srcu (npr. promjena srčanog ritma), bubregu (npr. smanjena količina mokraće, krv u mokraći) te živcima i mišićima (npr. mišićni spazmi, slabost, grčevi).
For clinical management of myelosuppression/cytopenias, see section 4.4.
Za kliničko zbrinjavanje mijelosupresije/citopenija vidjeti dio 4.4.
There is limited safety information available in patients with total bilirubin > 1.5 × ULN and AST/ALT > 2.5 × ULN prior to dosing.
U bolesnika s ukupnim bilirubinom > 1,5 × GGN i AST/ALT > 2,5 × GGN prije doziranja raspoloživi su ograničeni podaci o sigurnosti.
Dose modification(s)
Prilagodba(-e) doze
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).
Ako se ABN i/ili broj trombocita smanjuje, prekinuti sljedeći ciklus liječenja dok se ne dogodi barem jedno od niže navedenog: - ABN i broj trombocita se vrate barem na početne vrijednosti za prethodni ciklus, ili - ABN se vrati na ≥ 1 × 10
Adverse reactions reported in patients with relapsed or refractory B-cell precursor ALL who received BESPONSA
Tablica 5. Nuspojave zabilježene u bolesnika s recidivirajućom ili refraktornom ALL prekursora B-limfocita, koji su primali lijek BESPONSA
If the reconstituted solution cannot be used immediately, it may be stored in a refrigerator (2 °C-8 °C) for up to 4 hours.
Ako se rekonstituirana otopina ne može odmah iskoristiti, može se čuvati u hladnjaku (2°C - 8°C) do 4 sata.
Eligible patients were ≥ 18 years of age with relapsed or refractory B-cell precursor ALL.
Bolesnici podobni za uključivanje u ispitivanje su imali ≥ 18 godina i recidivirajući ili refraktorni ALL prekursora B-limfocita.
Administer diluted solution as a 1-hour infusion at a rate of 50 mL/h at room temperature (20 °C-25 °C).
Primijenite razrijeđenu otopinu kao jednosatnu infuziju brzinom od 50 ml/h na sobnoj temperaturi (20°C - 25°C).
Dose modifications for non-haematological toxicities at any time during treatment Non-haematological toxicity Dose modification(s)
Tablica 3. Prilagodbe doze za nehematološke toksičnosti u bilo kojem trenutku tijekom liječenja
Use reconstituted solution immediately or after being stored in a refrigerator (2 °C-8 °C) for up to 4 hours.
Iskoristite rekonstituiranu otopinu odmah ili nakon što je bila čuvana u hladnjaku (2°C8°C) najviše 4 sata.
No formal pharmacokinetic studies of inotuzumab ozogamicin have been conducted in patients with renal impairment.
Nisu provedena posebna farmakokinetička ispitivanja inotuzumab ozogamicina u bolesnika s oštećenjem bubrega.
A total of 276 (85%) patients had Ph- ALL.
Ukupno je 276 (85%) bolesnika imalo akutnu limfoblastičnu leukemiju s Philadephia negativnim (Ph
For patients who develop abnormal liver tests, liver tests and clinical signs and symptoms of hepatotoxicity should be monitored more frequently.
Preporučuje se češće praćenje jetrenih proba, kliničkih znakova i simptoma hepatotoksičnosti u bolesnika u kojih se pojave abnormalni nalazi jetrenih proba.
Inotuzumab ozogamicin has not been studied in patients with end-stage renal disease (see section 4.2).
Inotuzumab ozogamicin nije ispitivan u bolesnika sa završnom fazom bubrežne bolesti (vidjeti dio
For clinical management of TLS, see section 4.4.
Za kliničko zbrinjavanje TLS-a vidjeti dio 4.4.
Inotuzumab ozogamicin is an ADC composed of a CD22-directed monoclonal antibody that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Inotuzumab ozogamicin je konjugat protutijela i lijeka (engl. antibody drug conjugate, ADC) koji se sastoji od monoklonskog protutijela usmjerenog protiv CD22, koje je kovalentno vezano na N-acetilgama-kalikeamicindimetilhidrazid.
There was a trend in favour of BESPONSA, improvement grade small, for estimated mean postbaseline scores (BESPONSA and Investigator's choice, respectively) in global health status/Quality of Life (QoL) (62.1 versus 57.8), cognitive functioning (85.3 versus 82.5), dyspnoea (14.7 versus 19.4), diarrhoea (5.9 versus 8.9), fatigue (35.0 versus 39.4).
Quality of Life, QoL) (62,1 naspram 57,8), kognitivnom funkcioniranju (85,3 naspram 82,5), zadusi (14,7 naspram 19,4), proljevu (5,9 naspram 8,9), umoru (35,0 naspram 39,4).
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.
CI=interval pouzdanosti; CR=potpuna remisija; CRi=potpuna remisija s nepotpunim oporavkom krvne slike; DoR=trajanje remisije; EAC=Odbor za odlučivanje o mjerama ishoda; FLAG=fludarabin + citarabin
Headache (28%)
Infekcija (48%)
28 dayse
28 dana
In patients receiving inotuzumab ozogamicin, infusion related reactions were reported (see section 4.8).
Reakcije povezane s infuzijom su prijavljene u bolesnika koji primaju inotuzumab ozogamicin (vidjeti dio 4.8).
Inotuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody that specifically recognises human CD22.
Inotuzumab je humanizirani imunoglobulin razreda G podtipa 4
The OS improvement for BESPONSA versus Investigator's choice of chemotherapy arm was seen in patients who underwent HSCT.
U bolesnika koji su podvrgnuti HSCT-u zabilježeno je poboljšanje ukupnog preživljenja u skupini s lijekom BESPONSA u odnosu na one koji su primali kemoterapiju po izboru ispitivača.
- Use immediately or store at room temperature (20 °C-25 °C) or in a refrigerator (2 °C-8 °C).
- Iskoristiti odmah ili čuvati na sobnoj temperaturi (20°C - 25°C) ili u hladnjaku (2°C - 8°C).