natgillin/translations-raw huggingface dataset:
Consider permanent discontinuation of BESPONSA.
Razmotriti trajni prekid uzimanja lijeka BESPONSA.
Abbreviations: ALL=acute lymphoblastic leukaemia; ECG=electrocardiogram; GGT=gamma-glutamyltransferase; HSCT=haematopoietic stem cell transplant.
Skraćenice: ALL=akutna limfoblastična leukemija; EKG=elektrokardiogram; GGT=gama-glutamil transferaza; HSCT=transplantacija hematopoetskih matičnih stanica.
• have a history of liver problems or liver diseases or if you have signs and symptoms of a serious condition called hepatic venoocclusive disease, a condition in which the blood vessels in the liver become damaged and blocked by blood clots.
• imate povijest problema s jetrom ili bolesti jetre ili ako imate znakove i simptome teškog stanja koje se zove venska okluzivna bolest jetre, stanja u kojem krvni ugrušci oštete i začepe krvne žile u jetri.
Myelosuppression/cytopenias
Mijelosupresija/citopenije
This included 70 and 18 patients in the BESPONSA and Investigator's choice of chemotherapy arm, respectively, who proceeded directly to HSCT.
To je uključivalo 70 bolesnika na lijeku BESPONSA i 18 bolesnika na kemoterapiji po izboru ispitivača koji su odmah upućeni na HSCT.
The storage times and conditions for reconstitution, dilution, and administration of BESPONSA are shown below.
Vremena i uvjeti čuvanja za rekonstituciju, razrjeđivanje i primjenu lijeka BESPONSA su navedeni ispod.
Withdraw this amount from the vial(s) using a syringe.
Ovu količinu treba izvući iz bočice (bočica) pomoću štrcaljke.
The median age was 47 years (range: 18-79 years), 206 (63%) patients had a duration of first remission < 12 months, and 55 (17%) patients had undergone an HSCT prior to receiving BESPONSA or Investigator's choice of chemotherapy.
Medijan dobi je bio 47 godina (raspon: 18-79 godina), 206 (63%) bolesnika je bilo s vremenom < 12 mjeseci do prve remisije i 55 (17%) bolesnika je prošlo HSCT prije primitka lijeka BESPONSA ili kemoterapije po izboru ispitivača.
In the Phase 2 portion of the study, 8/35 (22.9%) patients had a follow-up HSCT.
U ispitivanju faze 2 8/35 (22,9%) bolesnika naknadno je prošlo HSCT.
However, if the diluted solution is filtered, polyethersulphone (PES)-, polyvinylidene fluoride (PVDF)-, or hydrophilic polysulphone (HPS)-based filters are recommended.
Međutim, ako se razrijeđena otopina filtrira, preporučuju se filteri bazirani na polietersulfonu (PES), poliviniliden fluoridu (PVDF) ili hidrofilnom polisulfonu (HPS).
If particles or discolouration are observed, do not use.
Ako primijetite čestice ili promjenu boje, nemojte ga koristiti.
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).
Potrebno je pažljivo procijeniti bolesnike s poviješću bolesti jetre (npr. ultrazvučna pretraga, testiranje na virusni hepatitis) prije liječenja lijekom BESPONSA kako bi se isključila mogućnost trenutne ozbiljne bolesti jetre (vidjeti dio 4.3).
Dosing regimen for Cycle 1 and subsequent cycles depending on response to treatment Day 1
Režim doziranja za 1. ciklus i sljedeće cikluse, ovisno o odgovoru na liječenje 1. dan
• The active substance is inotuzumab ozogamicin.
• Djelatna tvar je inotuzumab ozogamicin.
The primary analysis of CR/CRi and MRD negativity was conducted in the initial 218 randomised patients and the analysis of OS, PFS, DoR, and HSCT rate was conducted in all 326 randomised patients.
Primarna analiza CR/CRi-a i negativnog statusa MRD-a provedena je među prvih 218 randomiziranih bolesnika, a analiza OS-a, PFS-a, DoR-a i stope HSCT-a među svih 326 randomiziranih bolesnika.
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.
Potrebno je pažljivo razmotriti omjer koristi i rizika prije primjene lijeka BESPONSA u bolesnika u kojih se primjena režima kondicioniranja prije HSCT-a koji uključuju 2 alkilirajuća agensa u budućnosti vjerojatno neće moći izbjeći.
f In the standard definition of PFS, defined as the time from date of randomisation to earliest date of the following events: death, progressive disease (including objective progression and relapse from CR/CRi), the HR was 0.568 (2-sided p-value=0.0002) and median PFS was 5.6 months and 3.7 months in the BESPONSA and Investigator's choice of chemotherapy arm, respectively.
U standardnoj definiciji PFS, definiranoj kao vrijeme od datuma randomizacije do najranijeg datuma sljedećih događaja: smrt, progresija bolesti (uključujući objektivnu progresiju i recidiv s CR/CRi), omjer rizika je bio 0,568 (p-vrijednost dvostranog testa=0,0002) i medijan PFS od 5,6 mjeseci uz lijek BESPONSA i 3,7 mjeseci u skupini na kemoterapiji po izboru ispitivača.
Once attached to the lymphoblastic leukaemia cells, the medicine delivers a substance into the cells that interferes with the cells' DNA and eventually kills them.
Kada se veže na stanice limfoblastične leukemije, lijek u stanice unosi tvar koja ometa DNK stanica te ih na kraju ubija.
CD22 expression was assessed using flow cytometry based on bone marrow aspirate.
Ekspresija CD22 procjenjivala se protočnom citometrijom na temelju aspirata koštane srži.
Medicines given before treatment with BESPONSA
Lijekovi koji se daju prije liječenja lijekom BESPONSA
For patient-reported outcomes, most functioning and symptom scores were in favour of BESPONSA compared to Investigator's choice of chemotherapy.
Kada je riječ o rezultatima koje su prijavili bolesnici, bodovanje funkcioniranja i simptoma je većinom išlo u korist lijeka BESPONSA u usporedbi s ispitivačevim odabirom kemoterapije.
• Reduced number of white blood cells which may result in general weakness and a tendency to develop infections
• Smanjen broj bijelih krvnih stanica, što može rezultirati općom slabošću i sklonošću dobivanju infekcija
Do not use BESPONSA if you:
Nemojte primjenjivati lijek BESPONSA:
Pancytopeniab (2%)
Pancitopenija b (2%)
In all patients, liver tests should be monitored, including, ALT, AST, total bilirubin, and alkaline phosphatase, prior to and following each dose of BESPONSA.
Potrebno je pratiti jetrene probe, uključujući ALT, AST, ukupnu razinu bilirubina i alkalnu fosfatazu u svih bolesnika prije i nakon svake doze lijeka BESPONSA.
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.
Među bolesnicima u kojih je HSCT napravljen nakon liječenja lijekom BESPONSA, VOD/SOS je bio zabilježen u 5/11 (46%) bolesnika koji su primili HSCT prije i poslije liječenja lijekom BESPONSA i 13/68 (19%) bolesnika koji su primili HSCT samo nakon liječenja lijekom BESPONSA.
This medicine should be inspected visually for particulate matter and discolouration prior to administration.
Ovaj lijek treba vizualno pregledati na prisutnost čestica i promjenu boje prije primjene.
In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide was primarily metabolised via nonenzymatic reduction.
In vitro je N-acetil-gama-kalikeamicindimetilhidrazid prvenstveno metaboliziran putem neenzimske redukcije.
An increase in QTcF interval of > 450 msec was observed in 26/162 (16%) patients.
Produljenje QTcF intervala na > 450 ms opaženo je u 26/162 (16%) bolesnika.
In the pivotal study (N=164), infections, including serious infections, some of which were life-threatening or fatal, were reported in 79 (48%) patients.
U ključnom kliničkom ispitivanju (N=164) infekcije, uključujući ozbiljne infekcije, od kojih neke opasne po život ili fatalne, su bile zabilježene u 79 (48%) bolesnika.
In the pivotal study (N=164), infusion related reactions were reported in 17 (10%) patients.
U ključnom kliničkom ispitivanju (N=164) reakcije povezane s infuzijom su zabilježene u 17 (10%) bolesnika.
2), you may receive up to a maximum of 6 cycles of treatment.
možete primiti do maksimalno 6 ciklusa liječenja.
• Reduced number of lymphocytes (a type of white blood cells) which may result in a tendency to develop infections
• Smanjen broj limfocita (vrste bijelih krvnih stanica), što može rezultirati sklonošću dobivanju infekcija
• A doctor or nurse will give you BESPONSA through a drip in your vein (intravenous infusion) which will run for 1 hour.
• Liječnik ili medicinska sestra će Vam davati lijek BESPONSA putem infuzije u venu
How BESPONSA is given
Kako se BESPONSA daje
2-sided p-value < 0.0001 BESPONSA (N=164)
p-vrijednost dvostranog testa < 0,0001 BESPONSA (N=164)
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.
U bolesnika s recidivirajućom ili refraktornom ALL liječenih s inotuzumab ozogamicinom u preporučenoj početnoj dozi od 1,8 mg/m2/ciklus (vidjeti dio 4.2), izloženost u stanju dinamičke ravnoteže bila je postignuta do 4. ciklusa.
Any patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment (see Summary of Product Characteristics section 4.2).
U svakog bolesnika u kojeg unutar 3 ciklusa nije postignut CR/CRi treba prekinuti terapiju (vidjeti sažetak opisa svojstava lijeka, dio 4.2).
Preferred terms were retrieved by applying the Medical Dictionary for Regulatory Activities (MedDRA) version 19.1.
Medical Dictionary for Regulatory Activities, MedDRA), verzija 19.1.
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).
Trend u prilog lijeku BESPONSA zabilježen je u procijenjenim prosječnim rezultatima nakon početne vrijednosti izmjerene upitnikom EuroQoL 5 Dimension (EQ-5D) (BESPONSA, odnosno ispitivačev odabir kemoterapije) za EQ-5D indeks (0,80 naspram 0,76; najmanja značajna razlika za rak = 0,06).
Dosing regimen for Cycle 1 and subsequent cycles depending on response to treatment
Režim doziranja za 1. ciklus i sljedeće cikluse, ovisno o odgovoru na liječenje
Venoocclusive liver disease (sinusoidal obstruction syndrome) (3% [pre-HSCT]d)
Venookluzivna bolest jetre (sindrom sinusoidalne opstrukcije) (3% [prije HSCT-a]
IV infusion after reconstitution and dilution.
i.v. infuzija nakon rekonstitucije i razrjeđivanja.
No adjustment to the starting dose is required in patients with mild, moderate, or severe renal impairment (creatinine clearance [CLcr] 60-89 mL/min, 30-59 mL/min, or 15-29 mL/min, respectively) (see section 5.2).
Nije potrebna prilagodba početne doze u bolesnika s blagim, umjerenim ili teškim oštećenjem bubrega (klirens kreatinina [CLcr] 60-89 ml/min, 30-59 ml/min, odnosno 15-29 ml/min) (vidjeti dio 5.2).
If you need treatment with BESPONSA, you must stop breast-feeding during treatment and for at least 2 months after treatment.
Ako Vam je potrebno liječenje lijekom BESPONSA, morate prestati dojiti tijekom liječenja i najmanje 2 mjeseca nakon završetka liječenja.
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%).
Najčešće (≥ 20%) nuspojave su bile: trombocitopenija (51%), neutropenija (49%), infekcija (48%), anemija (36%), leukopenija (35%), umor (35%), hemoragija (33%), vrućica (32%), mučnina (31%), glavobolja (28%), febrilna neutropenija (26%), povećane razine transaminaza (26%), bol u abdomenu (23%), povećane razine gama-glutamil transferaze (21%) i hiperbilirubinemija (21%).
Grade ≥ 2a non-haematological toxicity (BESPONSA-related)
Nehematološka toksičnost stupnja a (povezana s primjenom lijeka BESPONSA)
Storage times and conditions for reconstituted and diluted BESPONSA solution
Vremena i uvjeti čuvanja rekonstituirane i razrijeđene otopine lijeka BESPONSA
• Reconstitute each 1 mg vial with 4 mL of water for injection, to obtain a single-use solution of 0.25 mg/mL of BESPONSA.
• Rekonstituirajte svaku bočicu od 1 mg s 4 ml vode za injekcije kako biste dobili otopinu s 0,25 mg/ml lijeka BESPONSA za jednokratnu upotrebu.
2-sided p-value = 0.0022
p-vrijednost dvostranog testa = 0,0022
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.
Preporučuje se spremnik za infuziju napravljen od polivinil klorida (PVC) (koji sadrži di-(2-etilheksil)ftalat [DEHP] ili koji ne sadrži DEHP), poliolefina (polipropilena i/ili polietilena) ili etilen vinil acetata (EVA).
For clinical management of hepatotoxicity, including VOD/SOS, see section 4.4.
Za kliničko zbrinjavanje hepatotoksičnosti, uključujući VOD/SOS, vidjeti dio 4.4.
Activation of N-acetyl-gamma-calicheamicin dimethylhydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Aktiviranje N-acetil-gama-kalikeamicindimetilhidrazida uzrokuje lomove dvolančane DNK te potom uzrokuje zastoj staničnog ciklusa i apoptotsku smrt stanice.
A third cycle may be considered for those patients who do not achieve a complete remission (CR) or complete remission with incomplete haematological recovery (CRi) and minimal residual disease (MRD) negativity after 2 cycles (see section 4.4).
Treći ciklus može se uzeti u obzir u onih bolesnika u kojih potpuna remisija (engl. complete remission, CR) nije postignuta, ili u kojih je postignuta potpuna remisija s nepotpunim oporavkom krvne slike (engl. complete remission with incomplete haematological recovery, CRi) i negativnim statusom minimalne ostatne bolesti (engl. minimal residual disease, MRD) nakon 2 ciklusa (vidjeti dio 4.4).
• 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.
• Tijekom infuzije zaštitite intravensku vrećicu od svjetlosti pomoću navlake koja blokira ultraljubičaste zrake (tj. pomoću vrećica jantarne, tamnosmeđe ili zelene boje ili aluminijske folije).
Treatment should be permanently discontinued if VOD/SOS occurs (see section 4.2).
Nužno je trajno prekinuti liječenje ako se pojavi VOD/SOS (vidjeti dio 4.2).
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).
Prijavljena je hepatotoksičnost, uključujući tešku, po život opasnu i ponekad fatalnu jetrenu VOD/SOS u bolesnika s recidivirajućom ili refraktornom ALL koji primaju lijek BESPONSA (vidjeti dio 4.8).
When considering the use of BESPONSA as a treatment for relapsed or refractory B cell ALL, baseline CD22 positivity of > 0% using a validated and sensitive assay is required prior to initiating treatment (see section 5.1).
Kad se razmatra primjena lijeka BESPONSA za liječenje recidivirajuće ili refraktorne B-stanične ALL, nužno je da se prije početka liječenja primjenom validiranog i osjetljivog testa utvrdi početna pozitivnost na CD22 > 0% (vidjeti dio 5.1).
Your doctor will take regular blood tests to monitor your liver enzymes during treatment with BESPONSA.
Liječnik će redovito provoditi krvne testove kako bi kontrolirao Vaše jetrene enzime tijekom liječenja lijekom BESPONSA.
In 1 monkey, a focus of hepatocellular alteration was detected at approximately 3.1 times the human clinical exposure based on AUC at the end of the 26-week dosing period.
U jednog (1) majmuna je žarište hepatocelularne promjene detektirano pri izloženosti dozama koje su približno 3,1 puta veće od kliničke izloženosti u ljudi na temelju AUC na kraju 26-tjednog razdoblja doziranja.
• infusion related reaction (see section 2); signs and symptoms include fever and chills or breathing problems during or shortly after the BESPONSA infusion.
• reakcije povezane s infuzijom (vidjeti dio 2); znakovi i simptomi uključuju vrućicu, zimicu ili probleme s disanjem tijekom ili neposredno nakon infuzije lijeka BESPONSA.
[4.5 to 7.9]
[3,9 do 5,8]
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 (koji ima gustoću od 1,02 g/ml pri temperaturi od 20°C/68°F) je osjetljiv na svjetlost te ga treba zaštititi od ultraljubičastih zraka tijekom rekonstitucije, razrjeđivanja i primjene.
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).
Ovisno o težini reakcije povezane s infuzijom, potrebno je razmotriti prekid infuzije ili primjenu steroida i antihistaminika (vidjeti dio 4.2).
For periodic monitoring of increased amylase and lipase, see section 4.4.
Za periodično praćenje povišenih razina amilaze i lipaze vidjeti dio 4.4.
Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD/SOS=venoocclusive disease/sinusoidal obstruction syndrome.
Skraćenice: ALT=alanin-aminotransferaza; AST=aspartat-aminotransferaza; GGN=gornja granica normalne vrijednosti; VOD/SOS=venookluzivna bolest/sindrom sinusoidalne opstrukcije.
In the pivotal study (N=164), TLS, which may be life-threatening or fatal, was reported in 4/164 (2%) patients.
U ključnom kliničkom ispitivanju (N=164) TLS, koji može biti opasan po život ili fatalan, je zabilježen u 4/164 (2%) bolesnika.
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.
NOAEL nije identificiran za učinke na muške reproduktivne organe koji su zabilježeni pri izloženosti približno 0,3 puta većoj od kliničke izloženosti u ljudi na temelju AUC.
• Your doctor will do blood tests during the treatment to check for side effects and for response to treatment.
• Vaš liječnik će Vas slati na krvne pretrage tijekom liječenja kako bi provjeravao postoje li nuspojave ili odgovor na liječenje.
The dose of inotuzumab ozogamicin is administered based on body surface area (see section 4.2).
Doza inotuzumab ozogamicina se primjenjuje ovisno o tjelesnoj površini (vidjeti dio 4.2).
• have signs and symptoms of an infusion related reaction, such as fever and chills or breathing problems during or shortly after the BESPONSA infusion.
• imate znakove ili simptome reakcija povezanih s infuzijom, kao što su vrućica i zimica tijekom ili ubrzo nakon infuzije lijeka BESPONSA.
Among the initial 218 randomised patients, 64/88 (73%) and 21/88 (24%) of responding patients per EAC achieved a CR/CRi in Cycles 1 and 2, respectively, in the BESPONSA arm. No additional patients achieved CR/CRi after Cycle 3 in the BESPONSA arm.
Među prvih 218 randomiziranih bolesnika, 64/88 (73%) i 21/88 (24%) bolesnika koji su reagirali na liječenje prema EAC-u je postiglo CR/CRi u 1., odnosno 2. ciklusu, u skupini koja je primila lijek BESPONSA.
The safety of immunisation with live viral vaccines during or following BESPONSA therapy has not been studied.
Sigurnost provođenja imunizacije živim virusnim cjepivima tijekom ili nakon liječenja lijekom BESPONSA nije ispitivana.
A total of 79/164 (48.2%) patients in the BESPONSA arm and 36/162 (22.2%) patients in the Investigator's choice of chemotherapy arm had a follow-up HSCT.
Ukupno je 79/164 (48,2%) bolesnika u skupini s lijekom BESPONSA i 36/162 (22,2%) bolesnika u skupini na kemoterapiji po izboru ispitivača prošlo naknadnu HSCT.
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).
Zbrinjavanje nekih nuspojava može zahtijevati prekide doziranja i/ili smanjenja doze, ili trajni prekid primjene lijeka BESPONSA (vidjeti dijelove 4.4 i 4.8).
Maximum time from reconstitution through the end of administration ≤ 8 hoursa Reconstituted solution
Maksimalno vrijeme od rekonstitucije do kraja primjene ≤ 8 sati Rekonstituirana otopina
Any patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment.
U svakog bolesnika u kojeg unutar 3 ciklusa nije postignut CR/CRi treba prekinuti liječenje.
In the event of an overdose, the infusion should be temporarily interrupted, and patients should be monitored for liver and haematological toxicities (see section 4.2).
U slučaju predoziranja infuziju treba privremeno prekinuti, a bolesnike pratiti kako bi se ustanovilo jesu li prisutne jetrene ili hematološke toksičnosti (vidjeti dio 4.2).
• Reduced number of red blood cells which may result in fatigue and shortness of breath
• Smanjen broj crvenih krvnih stanica, što može rezultirati umorom i nedostatkom zraka
For patients proceeding to a haematopoietic stem cell transplant (HSCT), the recommended duration of treatment is 2 cycles.
Bolesnicima koji liječenje nastavljaju s transplantacijom hematopoetskih matičnih stanica (engl. haematopoietic stem cell transplant, HSCT) preporučuje se trajanje liječenja od 2 ciklusa.
Day 15a
15. dan
Patient-reported outcomes measured using the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), were significantly better for BESPONSA by estimated mean postbaseline scores (BESPONSA and Investigator's choice of chemotherapy, respectively) for role functioning (64.7 versus 53.4, improvement grade small), physical functioning (75.0 versus 68.1, improvement grade small), social functioning (68.1 versus 59.8, improvement grade medium), and appetite loss (17.6 versus 26.3, improvement grade small) compared to Investigator's choice of chemotherapy.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30), bili su značajno bolji za lijek BESPONSA prema procijenjenim prosječnim rezultatima nakon početnih vrijednosti (BESPONSA, odnosno ispitivačev odabir kemoterapije) u pogledu ispunjavanja svoje uloge (64,7 naspram 53,4; mali stupanj poboljšanja), fizičkog funkcioniranja (75,0 naspram 68,1; mali stupanj poboljšanja), socijalnog funkcioniranja (68,1 naspram 59,8; srednji stupanj poboljšanja) i gubitka apetita (17,6 naspram 26,3; mali stupanj poboljšanja) u usporedbi s ispitivačevim odabirom kemoterapije.
Therefore, the concomitant use of inotuzumab ozogamicin with medicinal products known to prolong QT interval or to induce Torsades de Pointes should be carefully considered.
Stoga treba pažljivo razmotriti istodobnu primjenu inotuzumab ozogamicina i lijekova za koje je poznato da produljuju QT-interval ili koji izazivaju Torsades de Pointes.
In patients receiving inotuzumab ozogamicin, neutropenia, thrombocytopenia, anaemia, leukopenia, febrile neutropenia, lymphopenia, and pancytopenia, some of which were life-threatening, have been reported (see section 4.8).
U bolesnika koji primaju inotuzumab ozogamicin prijavljene su neutropenija, trombocitopenija, anemija, leukopenija, febrilna neutropenija, limfopenija i pancitopenija, od kojih su neke opasne po život (vidjeti dio 4.8).
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.
U tih bolesnika koji su odmah upućeni na HSCT medijan raspona vremena od zadnje doze inotuzumab ozogamicina do HSCT je bio 4,8 tjedana (raspon: 1-19 tjedana).
The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic product.
Mala molekula N-acetil-gamakalikeamicin je citotoksični lijek.
The secondary endpoints included MRD negativity, duration of remission (DoR), HSCT rate, and progression-free survival (PFS).
Sekundarni ishodi uključivali su negativni status minimalne ostatne bolesti (engl. minimal residual disease, MRD), trajanje remisije (engl. duration of remission, DoR), stopu HSCT-a i preživljenje bez progresije bolesti (engl. progression-free survival, PFS).