natgillin/translations-raw huggingface dataset:
Inotuzumab ozogamicin was clastogenic in vivo in the bone marrow of male mice.
Inotuzumab ozogamicin je bio klastogen in vivo u koštanoj srži mužjaka miševa.
If ANC decreases, interrupt the next cycle of treatment until recovery of ANC to ≥ 1 × 109/L.
Ako se ABN smanjuje, prekinuti sljedeći ciklus liječenja do povratka ABN-a na ≥ 1 × 10
In addition, inotuzumab ozogamicin and N-acetyl-gamma-calicheamicin dimethylhydrazide are unlikely to alter the exposure of substrates of CYP enzymes, and N-acetyl-gamma-calicheamicin dimethylhydrazide is unlikely to alter the exposure of substrates of UGT enzymes or major drug transporters.
Nadalje, nije vjerojatno da će inotuzumab ozogamicin i N-acetil-gama-kalikeamicindimetilhidrazid izmijeniti izloženost supstrata CYP enzima i nije vjerojatno da će N-acetil-gama-kalikeamicindimetilhidrazid izmijeniti izloženost supstrata UGT enzima ili glavnih prijenosnika lijeka.
[2.8 to 4.6] Hazard ratio [95% CI] = 0.471 [0.366-0.606] 2-sided p-value < 0.0001
[2,8 do 4,6] Omjer hazarda [95% CI] = 0,471 [0,366-0,606] p-vrijednost dvostranog testa < 0,0001
• 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.
• ako ste već bolovali od teške venske okluzivne bolesti (stanja u kojem krvni ugrušci oštete i začepe krvne žile u jetri) koja je bila potvrđena ili trenutno bolujete od venske okluzivne bolesti.
Of the 49 (15%) patients with Ph+ ALL, 4 patients did not receive a prior TKI, 28 patients received 1 prior TKI, and 17 patients received 2 prior TKIs.
Od 49 (15%) bolesnika s Ph ALL, 4 bolesnika nisu prethodno primili inhibitor tirozin kinaze (TKI), 28 bolesnika je primilo jedan
In 3 patients with hepatic impairment defined by NCI ODWG category C (total bilirubin > 1.5-3 × ULN and AST any level) and 1 patient with hepatic impairment defined by NCI ODWG category D (total bilirubin > 3 × ULN and AST any level), inotuzumab ozogamicin clearance did not appear to be reduced.
U 3 bolesnika s oštećenjem jetre, definiranim NCI ODWG-ovom kategorijom C (ukupni bilirubin > 1,5-3 × GGN i AST s bilo kojom razinom), i u jednog (1) bolesnika s oštećenjem funkcije jetre, definiranim NCI ODWG-ovom kategorijom D (ukupni bilirubin > 3 × GGN i AST s bilo kojom razinom), klirens inotuzumab ozogamicina se nije smanjio.
In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide is a substrate of P-glycoprotein (P-gp).
In vitro je N-acetil-gama-kalikeamicindimetilhidrazid supstrat P-glikoproteina (P-gp).
• Abnormally high levels of amylase (an enzyme needed for digestion and conversion of starch into sugars) in the blood
• Abnormalno visoke razine amilaze (enzima koji je potreban za probavu i pretvaranje škroba u šećere) u krvi
After reconstitution (see section 6.6), 1 mL of solution contains 0.25 mg inotuzumab ozogamicin.
Nakon rekonstitucije (vidjeti dio 6.6), 1 ml otopine sadrži 0,25 mg inotuzumab ozogamicina.
BESPONSA is for intravenous use.
BESPONSA je za intravensku primjenu.
Table 5 shows the adverse reactions reported in patients with relapsed or refractory ALL who received BESPONSA.
Tablica 5 prikazuje nuspojave zabilježene u bolesnika s recidivirajućom ili refraktornom ALL koji su primali lijek BESPONSA.
The co-primary endpoints were CR/CRi, assessed by a blinded independent endpoint adjudication committee (EAC), and overall survival (OS).
Endpoint Adjudication Committee, EAC) su bili CR/CRi i ukupno preživljenje (engl. overall survival, OS).
Furthermore, at month 24, the survival probability was 38.0% (95% CI: 27.4, 48.5) for patients who underwent a follow-up HSCT compared to 8.0% (95% CI: 3.3, 15.3) for patients who did not undergo a follow-up HSCT in the BESPONSA arm.
Nadalje, u 24. mjesecu, vjerojatnost preživljenja u bolesnika podvrgnutih naknadnom HSCT-u bila je 38,0% (95% CI: 27,4; 48,5) naspram 8,0% (95% CI: 3,3; 15,3) u bolesnika kojima naknadno nije proveden HSCT u skupini koja je primala lijek BESPONSA.
In repeat dose toxicity studies in rats and monkeys, female reproductive findings included atrophy of ovaries, uterus, vagina, and mammary gland.
U ispitivanjima toksičnosti ponovljene doze u štakora i majmuna, reproduktivni nalazi u ženki su uključivali atrofiju jajnika, maternice, rodnice i mliječnih žlijezda.
In patients who underwent a follow-up HSCT, the median OS was 11.9 months (95% CI: 9.2, 20.6) for BESPONSA versus 19.8 months (95% CI: 14.6, 26.7) for Investigator's choice of chemotherapy.
U bolesnika podvrgnutih naknadnoj HSCT medijan ukupnog preživljenja je bio 11,9 mjeseci (95% CI: 9,2; 20,6) u skupini koja je primala lijek BESPONSA u odnosu na 19,8 mjeseci (95% CI: 14,6; 26,7) u onih koji su primali kemoterapiju po izboru ispitivača.
In the following subgroups, the reported frequency of VOD/SOS post-HSCT was ≥ 50%: - Patients who received a HSCT conditioning regimen containing 2 alkylating agents; - Patients aged ≥ 65 years; and
U sljedećim podgrupama prijavljena je učestalost VOD/SOS-a nakon HSCT-a bila ≥ 50%: - Bolesnici koji su primili režim kondicioniranja za HSCT koji uključuje 2 alkilirajuća agensa; - Bolesnici u dobi od ≥ 65 godina, i - Bolesnici s razinom bilirubina u serumu ≥ GGN prije HSCT-a.
Formal carcinogenicity studies have not been conducted with inotuzumab ozogamicin.
Nisu provedena posebna ispitivanja kancerogenosti s inotuzumab ozogamicinom.
a Severity grade according to National Cancer Institute Common Terminology Criteria for Adverse Events
Stupanj težine prema Zajedničkim kriterijima terminologije za nuspojave Nacionalnog instituta za rak (engl.
N-acetyl-gamma-calicheamicin dimethylhydrazide (the cytotoxic agent released from inotuzumab ozogamicin) was mutagenic in an in vitro bacterial reverse mutation (Ames) assay.
N-acetil-gama-kalikeamicindimetilhidrazid (citotoksična tvar koju otpušta inotuzumab ozogamicin) bio je mutagen u in vitro testu bakterijske reverzne mutacije (Amesov test).
In patients who received BESPONSA, the most common (≥ 2%) serious adverse reactions were infection (23%), febrile neutropenia (11%), haemorrhage (5%), abdominal pain (3%), pyrexia (3%), VOD/SOS (2%), and fatigue (2%).
Najčešće (≥ 2%) su ozbiljne nuspojave u bolesnika koji su primali lijek BESPONSA bile infekcija (23%), febrilna neutropenija (11%), hemoragija (5%), bol u abdomenu (3%), vrućica (3%), VOD/SOS (2%) i umor (2%).
Grade ≥ 3 hyperbilirubinaemia and increased transaminases were reported in 9 (6%) and 11 (7%) patients, respectively.
Hiperbilirubinemija ≥ 3. stupnja i povećana razina transaminaza bile su zabilježene u 9 (6%), odnosno 11 (7%) bolesnika.
Venoocclusive disease may be fatal and is associated with rapid weight gain, pain in the upper right side of your abdomen (belly), increase in the size of the liver, build-up of fluid causing abdominal swelling, and blood tests showing increases in bilirubin and/or liver enzymes (that may result in yellowing of the skin or eyes).
Venska okluzivna bolest može biti smrtonosna te se povezuje s naglim dobivanjem na težini, boli na gornjoj desnoj strani trbuha, povećanjem veličine jetre, nakupljanjem tekućine koje uzrokuje oticanje trbuha i povećanjem razina bilirubina i/ili jetrenih enzima u rezultatima krvnih pretraga (što može rezultirati žutom bojom kože ili očiju).
2-sided p-value < 0.0001
p-vrijednost dvostranog testa < 0,0001
No patients tested positive for neutralising anti-inotuzumab ozogamicin antibodies.
Nijedan od bolesnika nije imao pozitivne nalaze testa na neutralizirajuća protutijela protiv inotuzumab ozogamicina.
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).
Smatra se da inotuzumab ozogamicin ima potencijal oštetiti reproduktivnu funkciju i plodnost u muškaraca i žena na temelju nekliničkih nalaza.
Increases in Grade ≥ 3 amylase and lipase were reported in 3 (2%) and 7 (4%) patients, respectively.
Povećanja amilaze i lipaze ≥ 3. stupnja zabilježena su u 3 (2%), odnosno 7 (4%) bolesnika.
For storage conditions after reconstitution and dilution, see section 6.3.
Uvjete čuvanja nakon rekonstitucije i razrjeđivanja lijeka vidjeti u dijelu 6.3.
Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA (see section 4.2).
Povećanje razina u nalazima jetrenih proba može zahtijevati privremeni prekid doziranja, smanjenje doze ili trajni prekid primjene lijeka BESPONSA (vidjeti dio 4.2).
Diluted solution After start of dilution
Nakon početka razrjeđivanja
Type I amber glass vial with chlorobutyl rubber stopper and crimp seal with flip off cap containing 1 mg of powder.
I boje jantara, s klorobutilnim gumenim čepom te prstenastim zatvaračem s flipoff kapicom, koja sadrži 1 mg praška.
ECG QT prolonged (1%) Increased amylase (5%)
Produljeni QT-interval na EKG-u (1%) Povećane razine amilaze
Infusion lines made of PVC (DEHP or non-DEHP-containing), polyolefin (polypropylene and/or polyethylene), or polybutadiene are recommended.
Preporučuju se cjevčice za infuziju napravljene od PVCa (koji sadrži DEHP ili koji ne sadrži DEHP), poliolefina (polipropilena i/ili polietilena) ili polibutadiena.
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.
Skraćenice: ALL=akutna limfoblastična leukemija; ABN=apsolutni broj neutrofila; CI=interval pouzdanosti; CR=potpuna remisija; CRi=potpuna remisija s nepotpunim oporavkom krvne slike; DoR=trajanje remisije; HSCT=transplantacija hematopoetskih matičnih stanica; MRD=minimalna ostatna bolest; N/n=broj bolesnika; OS=ukupno preživljenje; PFS=preživljenje bez progresije bolesti.
Patients with relapsed or refractory ALL who have received 1 or 2 prior treatment regimens for ALL - Study 1
Bolesnici s recidivirajućom ili refraktornom ALL koji su već primili 1 ili 2 režima liječenja za ALL - Ispitivanje 1
Hyperbilirubinaemia (21%) Increased transaminases (26%) Increased GGT (21%)
Hiperbilirubinemija (21%) Povećane razine transaminaza
- Patients with serious ongoing hepatic disease (e.g., cirrhosis, nodular regenerative hyperplasia,
- Bolesnici koji trenutno boluju od ozbiljne bolesti jetre (npr. ciroze, nodularne regenerativne hiperplazije, aktivnog hepatitisa).
Dosing regimen for subsequent cycles depending on response to treatment Patients who have achieved a CRc or CRid:
21 dan Režim doziranja za sljedeće cikluse, ovisno o odgovoru na liječenje Bolesnici u kojih je postignut CR c ili CRi
b Pancytopenia includes the following reported preferred terms: Bone marrow failure, Febrile bone marrow aplasia, and Pancytopenia.
Pancitopenija uključuje sljedeće zabilježene preporučene nazive: zatajenje koštane srži, febrilna aplazija koštane srži i pancitopenija.
Patients with relapsed or refractory ALL who have received 2 or more prior treatment regimens for ALL - Study 2
Bolesnici s recidivirajućom ili refraktornom ALL koji su prethodno primili 2 ili više režima liječenja za ALL - Ispitivanje 2
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).
U dijelu ispitivanja faze I, 37 bolesnika je primilo lijek BESPONSA u ukupnoj dozi od 1,2 mg/m (n=3), 1,6 mg/m 2 (n=12) ili 1,8 mg/m 2 (n=22).
• Excessive accumulation of fluid in the abdomen
• Pretjerano nakupljanje tekućine u trbuhu
The maximum time from reconstitution through the end of administration should be ≤ 8 hours, with ≤ 4 hours between reconstitution and dilution.
Maksimalno vrijeme od rekonstitucije do kraja primjene treba biti ≤ 8 sati, s tim da između rekonstitucije i razrjeđivanja smije proći ≤ 4 sata.
Regarding other risk factors, VOD/ SOS was reported in 6/11 (55%) patients who received a HSCT conditioning regimen containing 2 alkylating agents and 9/53 (17%) patients who received a HSCT conditioning regimen containing 1 alkylating agent, 7/17 (41%) patients who were ≥ 55 years old and 11/62 (18%) patients who were < 55 years old, and 7/12 (58%) patients with a serum bilirubin ≥ ULN prior to HSCT and in 11/67 (16%) patients with a serum bilirubin < ULN prior to HSCT.
Što se tiče ostalih čimbenika rizika, VOD/SOS je prijavljen u 6/11 (55%) bolesnika koji su prošli režim kondicioniranja za HSCT koji uključuje 2 alkilirajuća agensa i 9/53 (17%) bolesnika koji su prošli režim kondicioniranja za HSCT koji uključuje 1 alkilirajući agens, 7/17 (41%) bolesnika u dobi od ≥ 55 godina i 11/62 (18%) bolesnika u dobi
The no observed adverse effect level (NOAEL) for the effects on female reproductive organs in rats and monkeys was approximately 2.2 and 3.1 times the human clinical exposure based on AUC, respectively.
Razina izloženosti pri kojoj nisu opaženi štetni učinci (engl. no observed adverse effect level, NOAEL) za učinke na reproduktivne organe ženki štakora i majmuna je bila oko 2,2, odnosno 3,1 veća od kliničke izloženosti u ljudi na temelju AUC.
In the pivotal study (N=164), hyperbilirubinaemia and increased transaminases were reported in 35 (21%) and 43 (26%) patients, respectively.
U ključnom kliničkom ispitivanju (N=164) hiperbilirubinemija i povećana razina transaminaza su bile zabilježene u 35 (21%), odnosno 43 (26%) bolesnika.
Grade 3/4 TLS was reported in 3 (2%) patients.
Slučajevi TLS-a 3./4. stupnja su zabilježeni u 3 (2%) bolesnika.
Increases in QTcF interval of > 450 msec and > 500 msec were observed in 26/162 (16%) and none of the patients in the inotuzumab ozogamicin arm versus 12/124 (10%) and 1/124 (1%) patients in the Investigator's choice of chemotherapy arm, respectively (see section 4.8).
Produljenja QTcF intervala na > 450 ms i > 500 ms zabilježena su u 26/162 (16%) bolesnika odnosno ni u jednog bolesnika iz skupine koja je primala inotuzumab ozogamicin, naspram 12/124 (10%) odnosno 1/124 (1%) bolesnika u skupini s kemoterapijom po izboru ispitivača (vidjeti dio 4.8).
Men with female partners of childbearing potential should use effective contraception during treatment with BESPONSA and for at least 5 months after the last dose.
Muškarci koji imaju partnerice koje mogu zatrudnjeti trebaju koristiti učinkovitu kontracepciju tijekom liječenja lijekom BESPONSA i najmanje 5 mjeseci nakon zadnje doze.
Based on non-clinical findings, male and female fertility may be compromised by treatment with inotuzumab ozogamicin (see section 5.3).
Na temelju nekliničkih nalaza, liječenje inotuzumab ozogamicinom može ugroziti plodnost muškarca i žene (vidjeti dio 5.3).
[4.7 to 8.3] Hazard ratio [95% CI] = 0.751 [0.588-0.959] 2-sided p-value = 0.0210
[4,7 do 8,3] Omjer hazarda [95% CI] = 0,751 [0,588-0,959] p-vrijednost dvostranog testa = 0,0210
Grade 3/4 bleeding/haemorrhagic events were reported in 8/164 (5%) patients.
Slučajevi krvarenja/hemoragije 3./4. stupnja su zabilježeni u 8/164 (5%) bolesnika.
Based on population pharmacokinetic analysis in 765 patients, the clearance of inotuzumab ozogamicin in patients with mild renal impairment (CLcr 60-89 mL/min; n=237), moderate renal impairment (CLcr 30-59 mL/min; n=122), or severe renal impairment (CLcr 15-29 mL/min; n=4) was similar to patients with normal renal function (CLcr ≥ 90 mL/min; n=402) (see section 4.2).
Na osnovi populacijske farmakokinetičke analize u 765 bolesnika, klirens inotuzumab ozogamicina u bolesnika s blagim oštećenjem bubrega (CLcr 60-89 ml/min; n=237), umjerenim oštećenjem bubrega (CLcr 30-59 ml/min; n=122) ili teškim oštećenjem bubrega (CLcr 15-29 ml/min; n=4) bio je sličan onome u bolesnika s normalnom funkcijom bubrega (CLcr ≥ 90 ml/min; n=402) (vidjeti dio 4.2).
In the pivotal study (N=164), increases in amylase and lipase were reported in 8 (5%) and 15 (9%) patients, respectively.
U ključnom kliničkom ispitivanju (N=164) povišene razine amilaze i lipaze zabilježene su u 8 (5%), odnosno 15 (9%) bolesnika.
For periodic monitoring of ECG and electrolyte levels, see section 4.4.
Za periodično praćenje EKG-a i razina elektrolita vidjeti dio 4.4.
• Abnormally high levels of lipase (an enzyme needed to process dietary fat) in the blood
• Abnormalno visoke razine lipaze (enzima koji je potreban kako bi se preradile masnoće iz hrane) u krvi
The frequencies of specific infections were: sepsis and bacteraemia (17%), lower respiratory tract infection (12%), upper respiratory tract infection (12%), fungal infection (9%), viral infection (7%), gastrointestinal infection (4%), skin infection (4%), and bacterial infection (1%).
Učestalosti sspecifičnih infekcija bile su: sepsa i bakterijemija (17%), infekcija donjih dišnih putova (12%), infekcija gornjih dišnih putova (12%), gljivična infekcija (9%), virusna infekcija (7%), gastrointestinalna infekcija (4%), infekcija kože (4%) i bakterijska infekcija (1%).
Grade 4 thrombocytopenia and neutropenia were reported in 46 (28%) and 45 (27%) patients, respectively.
Trombocitopenija i neutropenija 4. stupnja su bile zabilježene u 46 (28%), odnosno 45 (27%) bolesnika.
Re-initiation of BESPONSA at the correct therapeutic dose should be considered when all toxicities have resolved.
Kad se povuku sve toksičnosti, treba razmotriti ponovnu primjenu lijeka BESPONSA, uz točnu terapijsku dozu.
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.
a-a ili CRi b-a prema procjeni ispitivača do dana događaja PFS-a ili dana cenzuriranja ako nijedan događaj PFS-a nije dokumentiran.
• 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 znakove ili simptome niskog broja krvnih stanica poznatih kao neutrofili (što je ponekad popraćeno vrućicom), crvenih krvnih stanica, bijelih krvnih stanica, limfocita ili niskog broja krvnih sastojaka poznatih kao trombociti; ovi znakovi i simptomi uključuju dobivanje infekcije ili vrućice ili lako dobivanje modrica ili često krvarenje iz nosa.
Nonclinical data suggest that the anticancer activity of BESPONSA is due to the binding of the ADC to CD22-expressing tumour cells, followed by internalisation of the ADC-CD22 complex, and the intracellular release of N-acetyl-gamma-calicheamicin dimethylhydrazide via hydrolytic cleavage of the linker.
Neklinički podaci ukazuju da lijek BESPONSA ima antitumorsku aktivnost zahvaljujući vezivanju ADC-a na tumorske stanice s ekspresijom CD22, nakon čega slijedi unos ADC-CD22 kompleksa i unutarstanično otpuštanje N-acetil-gama-kalikeamicindimetilhidrazida putem hidrolitičkog cijepanja poveznice.
Patients may experience fatigue during treatment with BESPONSA (see section 4.8).
Bolesnici mogu osjetiti umor tijekom liječenja lijekom BESPONSA (vidjeti dio 4.8).
• low number of blood cells known as neutrophils, (sometimes accompanied with fever), red blood cells, white blood cells, lymphocytes, or low number of blood components known as platelets (see section 2); signs and symptoms include developing an infection or fever or bruising easily or getting nose bleeds on a regular basis.
• nizak broj krvnih stanica poznatih kao neutrofili (što je ponekad popraćeno vrućicom), crvenih krvnih stanica, bijelih krvnih stanica, limfocita ili nizak broj krvnih sastojaka poznatih kao trombociti (vidjeti dio 2); znakovi i simptomi uključuju razvoj infekcije, vrućicu, lako nastajanje modrica ili redovito krvarenje iz nosa.
• venoocclusive liver disease (see section 2); signs and symptoms include rapid weight gain, pain in the upper right side of your abdomen, increase in the size of the liver, accumulation of fluid causing abdominal swelling, and increases in bilirubin and/or liver enzymes (that may result in yellowing of the skin or eyes).
• venska okluzivna bolest jetre (vidjeti dio 2); znakovi i simptomi uključuju nagli porast tjelesne težine, bol u gornjem desnom dijelu trbuha, povećanje veličine jetre, nakupljanje tekućine uzrokujući oticanje trbuha i porast bilirubina i/ili jetrenih enzima (što može rezultirati žutom bojom kože ili očiju).
Men must use effective contraception during treatment and for at least 5 months after the last dose of treatment.
Muškarci moraju koristiti učinkovitu kontracepciju tijekom liječenja te najmanje 5 mjeseci nakon primitka zadnje doze.
Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
Inotuzumab ozogamicin je konjugat protutijela i lijeka (engl. antibody-drug conjugate, ADC) sastavljen od rekombinantnog humaniziranog IgG4 kappa monoklonskog protutijela usmjerenog protiv CD22 (proizvedenog u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK), kovalentno vezanog na N-acetil-gama-kalikeamicindimetilhidrazid.
BESPONSA 1 mg powder for concentrate for solution for infusion inotuzumab ozogamicin
BESPONSA 1 mg prašak za koncentrat za otopinu za infuziju inotuzumab ozogamicin
In repeat dose toxicity studies in rats, male reproductive findings included testicular degeneration, associated with hypospermia, and prostatic and seminal vesicle atrophy.
U ispitivanjima toksičnosti ponovljene doze u štakora, reproduktivni nalazi u mužjaka su uključivali testikularnu degeneraciju povezanu s hipospermijom te atrofiju prostate i atrofiju sjemenskog mjehurića.
For patients not proceeding to HSCT, a maximum of 6 cycles may be administered.
U bolesnika koji liječenje neće nastaviti s HSCT-om može se primijeniti maksimalno 6 ciklusa.
- Patients who have experienced prior confirmed severe or ongoing venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS).
- Bolesnici koji su već bolovali od potvrđene teške venookluzivne bolesti jetre/sindroma sinusoidalne opstrukcije (VOD/SOS) ili koji trenutno boluju od VOD/SOS.
Your doctor will take regular blood tests to monitor your blood counts during treatment with BESPONSA.
Liječnik će Vam redovito provoditi krvne testove kako bi kontrolirao Vašu krvnu sliku tijekom liječenja lijekom BESPONSA.
In the pivotal clinical study (N=164), bleeding/haemorrhagic events, mostly mild in severity, were reported in 54/ (33%) patients.
U ključnom kliničkom ispitivanju (N=164) slučajevi krvarenja/hemoragije, većinom blagog intenziteta, su zabilježeni u 54 (33%) bolesnika.
Interrupt the infusion and institute appropriate medical management.
Reakcija povezana s infuzijom Prekinuti infuziju i započeti s odgovarajućim medicinskim zbrinjavanjem.
Based on in vitro data, coadministration of inotuzumab ozogamicin with inhibitors or inducers of cytochrome P450 (CYP) or uridine diphosphate-glucuronosyltransferase (UGT) drug metabolising enzymes are unlikely to alter exposure to N-acetyl-gamma-calicheamicin dimethylhydrazide.
In vitro podaci pokazuju da nije vjerojatno da će istodobna primjena inotuzumab ozogamicina s inhibitorima ili induktorima enzima citokroma P450 (CYP) ili uridin-difosfat-glukuronoziltransferaze (UGT), koji metaboliziraju lijek, izmijeniti izloženost N-acetil-gama-kalikeamicindimetilhidrazidu.
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.
PFS je definiran kao vrijeme od dana randomizacije do najranijeg dana sljedećih događaja: smrt, progresivna bolest (uključujući objektivno napredovanje, recidiv od CR/CRi-a, trajni prekid liječenja zbog sveopćeg pogoršanja zdravstvenog stanja) i početak nove indukcijske terapije ili HSCT-a nakon terapije bez postizanja CR/CRi-a.