FrancophonIA/ELRC3.0 huggingface dataset:
English: Infusion lines made of PVC (DEHP or non-DEHP-containing), polyolefin (polypropylene and/or polyethylene), or polybutadiene are recommended.
Croatian: Preporučuju se cjevčice za infuziju napravljene od PVCa (koji sadrži DEHP ili koji ne sadrži DEHP), poliolefina (polipropilena i/ili polietilena) ili polibutadiena.
English: 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.
Croatian: 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.
English: Patients with relapsed or refractory ALL who have received 1 or 2 prior treatment regimens for ALL - Study 1
Croatian: Bolesnici s recidivirajućom ili refraktornom ALL koji su već primili 1 ili 2 režima liječenja za ALL - Ispitivanje 1
English: Hyperbilirubinaemia (21%) Increased transaminases (26%) Increased GGT (21%)
Croatian: Hiperbilirubinemija (21%) Povećane razine transaminaza
English: - Patients with serious ongoing hepatic disease (e.g., cirrhosis, nodular regenerative hyperplasia,
Croatian: - Bolesnici koji trenutno boluju od ozbiljne bolesti jetre (npr. ciroze, nodularne regenerativne hiperplazije, aktivnog hepatitisa).
English: Dosing regimen for subsequent cycles depending on response to treatment Patients who have achieved a CRc or CRid:
Croatian: 21 dan Režim doziranja za sljedeće cikluse, ovisno o odgovoru na liječenje Bolesnici u kojih je postignut CR c ili CRi
English: b Pancytopenia includes the following reported preferred terms: Bone marrow failure, Febrile bone marrow aplasia, and Pancytopenia.
Croatian: Pancitopenija uključuje sljedeće zabilježene preporučene nazive: zatajenje koštane srži, febrilna aplazija koštane srži i pancitopenija.
English: Patients with relapsed or refractory ALL who have received 2 or more prior treatment regimens for ALL - Study 2
Croatian: Bolesnici s recidivirajućom ili refraktornom ALL koji su prethodno primili 2 ili više režima liječenja za ALL - Ispitivanje 2
English: 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).
Croatian: 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).
English: • Excessive accumulation of fluid in the abdomen
Croatian: • Pretjerano nakupljanje tekućine u trbuhu
English: The maximum time from reconstitution through the end of administration should be ≤ 8 hours, with ≤ 4 hours between reconstitution and dilution.
Croatian: Maksimalno vrijeme od rekonstitucije do kraja primjene treba biti ≤ 8 sati, s tim da između rekonstitucije i razrjeđivanja smije proći ≤ 4 sata.
English: 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.
Croatian: 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
English: 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.
Croatian: 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.
English: In the pivotal study (N=164), hyperbilirubinaemia and increased transaminases were reported in 35 (21%) and 43 (26%) patients, respectively.
Croatian: U ključnom kliničkom ispitivanju (N=164) hiperbilirubinemija i povećana razina transaminaza su bile zabilježene u 35 (21%), odnosno 43 (26%) bolesnika.
English: Grade 3/4 TLS was reported in 3 (2%) patients.
Croatian: Slučajevi TLS-a 3./4. stupnja su zabilježeni u 3 (2%) bolesnika.
English: 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).
Croatian: 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).
English: 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.
Croatian: Muškarci koji imaju partnerice koje mogu zatrudnjeti trebaju koristiti učinkovitu kontracepciju tijekom liječenja lijekom BESPONSA i najmanje 5 mjeseci nakon zadnje doze.
English: Based on non-clinical findings, male and female fertility may be compromised by treatment with inotuzumab ozogamicin (see section 5.3).
Croatian: Na temelju nekliničkih nalaza, liječenje inotuzumab ozogamicinom može ugroziti plodnost muškarca i žene (vidjeti dio 5.3).
English: [4.7 to 8.3] Hazard ratio [95% CI] = 0.751 [0.588-0.959] 2-sided p-value = 0.0210
Croatian: [4,7 do 8,3] Omjer hazarda [95% CI] = 0,751 [0,588-0,959] p-vrijednost dvostranog testa = 0,0210
English: Grade 3/4 bleeding/haemorrhagic events were reported in 8/164 (5%) patients.
Croatian: Slučajevi krvarenja/hemoragije 3./4. stupnja su zabilježeni u 8/164 (5%) bolesnika.
English: 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).
Croatian: 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).
English: In the pivotal study (N=164), increases in amylase and lipase were reported in 8 (5%) and 15 (9%) patients, respectively.
Croatian: U ključnom kliničkom ispitivanju (N=164) povišene razine amilaze i lipaze zabilježene su u 8 (5%), odnosno 15 (9%) bolesnika.
English: For periodic monitoring of ECG and electrolyte levels, see section 4.4.
Croatian: Za periodično praćenje EKG-a i razina elektrolita vidjeti dio 4.4.
English: • Abnormally high levels of lipase (an enzyme needed to process dietary fat) in the blood
Croatian: • Abnormalno visoke razine lipaze (enzima koji je potreban kako bi se preradile masnoće iz hrane) u krvi
English: 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%).
Croatian: 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%).
English: Grade 4 thrombocytopenia and neutropenia were reported in 46 (28%) and 45 (27%) patients, respectively.
Croatian: Trombocitopenija i neutropenija 4. stupnja su bile zabilježene u 46 (28%), odnosno 45 (27%) bolesnika.
English: Re-initiation of BESPONSA at the correct therapeutic dose should be considered when all toxicities have resolved.
Croatian: Kad se povuku sve toksičnosti, treba razmotriti ponovnu primjenu lijeka BESPONSA, uz točnu terapijsku dozu.
English: 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.
Croatian: a-a ili CRi b-a prema procjeni ispitivača do dana događaja PFS-a ili dana cenzuriranja ako nijedan događaj PFS-a nije dokumentiran.
English: • 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.
Croatian: • 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.
English: 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.
Croatian: 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.
English: Patients may experience fatigue during treatment with BESPONSA (see section 4.8).
Croatian: Bolesnici mogu osjetiti umor tijekom liječenja lijekom BESPONSA (vidjeti dio 4.8).
English: • 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.
Croatian: • 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.
English: • 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).
Croatian: • 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).
English: Men must use effective contraception during treatment and for at least 5 months after the last dose of treatment.
Croatian: Muškarci moraju koristiti učinkovitu kontracepciju tijekom liječenja te najmanje 5 mjeseci nakon primitka zadnje doze.
English: 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.
Croatian: 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.
English: BESPONSA 1 mg powder for concentrate for solution for infusion inotuzumab ozogamicin
Croatian: BESPONSA 1 mg prašak za koncentrat za otopinu za infuziju inotuzumab ozogamicin
English: In repeat dose toxicity studies in rats, male reproductive findings included testicular degeneration, associated with hypospermia, and prostatic and seminal vesicle atrophy.
Croatian: 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.
English: For patients not proceeding to HSCT, a maximum of 6 cycles may be administered.
Croatian: U bolesnika koji liječenje neće nastaviti s HSCT-om može se primijeniti maksimalno 6 ciklusa.
English: - Patients who have experienced prior confirmed severe or ongoing venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS).
Croatian: - Bolesnici koji su već bolovali od potvrđene teške venookluzivne bolesti jetre/sindroma sinusoidalne opstrukcije (VOD/SOS) ili koji trenutno boluju od VOD/SOS.
English: Your doctor will take regular blood tests to monitor your blood counts during treatment with BESPONSA.
Croatian: Liječnik će Vam redovito provoditi krvne testove kako bi kontrolirao Vašu krvnu sliku tijekom liječenja lijekom BESPONSA.
English: In the pivotal clinical study (N=164), bleeding/haemorrhagic events, mostly mild in severity, were reported in 54/ (33%) patients.
Croatian: U ključnom kliničkom ispitivanju (N=164) slučajevi krvarenja/hemoragije, većinom blagog intenziteta, su zabilježeni u 54 (33%) bolesnika.
English: Interrupt the infusion and institute appropriate medical management.
Croatian: Reakcija povezana s infuzijom Prekinuti infuziju i započeti s odgovarajućim medicinskim zbrinjavanjem.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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%).
Croatian: 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%].
English: 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%])
Croatian: 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%])
English: BESPONSA 1 mg powder for concentrate for solution for infusion
Croatian: BESPONSA 1 mg prašak za koncentrat za otopinu za infuziju
English: In patients receiving inotuzumab ozogamicin, TLS, which may be life-threatening or fatal, was reported (see section 4.8).
Croatian: U bolesnika koji primaju inotuzumab ozogamicin prijavljen je TLS, koji može biti opasan po život ili imati smrtni ishod (vidjeti dio 4.8).
English: Grade 3 thrombocytopenia and neutropenia were reported in 23 (14%) and 33 (20%) patients, respectively.
Croatian: Trombocitopenija i neutropenija 3. stupnja su bile zabilježene u 23 (14%), odnosno 33 (20%) bolesnika.
English: In the pivotal study (N=164), thrombocytopenia and neutropenia were reported in 83 (51%) and 81 (49%) patients, respectively.
Croatian: U ključnom kliničkom ispitivanju (N=164) trombocitopenija i neutropenija su zabilježene u 83 (51%), odnosno 81 (49%) bolesnika.
English: BESPONSA acts by attaching to cells with a protein called CD22.
Croatian: BESPONSA djeluje tako da se veže na stanice s bjelančevinom koja se zove CD22.
English: - Store in a refrigerator (2 °C-8 °C).
Croatian: - Čuvati u hladnjaku (2°C - 8°C).
English: MRD negativityc for patients achieving CR/CRi; rated (%) [95% CI]
Croatian: Negativni status MRD-a c u bolesnika koji postižu CR/CRi; stopa d (%) [95%
English: Day 8a
Croatian: 8. dan
English: For clinical management of infusion related reactions, see section 4.4.
Croatian: Za kliničko zbrinjavanje reakcija povezanih s infuzijom vidjeti dio 4.4.
English: 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
Croatian: 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
English: 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.
Croatian: 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.
English: For severe or life-threatening infusion reactions, permanently discontinue treatment (see section 4.4).
Croatian: U slučaju reakcija povezanih s infuzijom koje su ozbiljne ili opasne po život, trajno prekinuti liječenje (vidjeti dio 4.4).
English: Pyrexia (32%) Fatigue (35%) Chills (11%)
Croatian: Vrućica (32%) Umor (35%) Zimica (11%)
English: Each vial contains 1 mg inotuzumab ozogamicin.
Croatian: Jedna bočica sadrži 1 mg inotuzumab ozogamicina.
English: 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.
Croatian: 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.
English: For patients not proceeding to HSCT, a maximum of 6 cycles, may be administered.
Croatian: U bolesnika koji liječenje neće nastaviti sa HSCT-om, može se primijeniti do maksimalno 6 ciklusa.
English: BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22positive B cell precursor acute lymphoblastic leukaemia (ALL).
Croatian: 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
English: If platelet count decreases, interrupt the next cycle of treatment until platelet count recovers to ≥ 50 × 109/La.
Croatian: Ako se broj trombocita smanjuje, prekinuti sljedeći ciklus liječenja do obnavljanja broja trombocita na ≥ 50 × 10
English: • Infuse the diluted solution for 1 hour at a rate of 50 mL/h at room temperature (20 °C-25 °C).
Croatian: • Infundirajte razrijeđenu otopinu tijekom 1 sat brzinom od 50 ml/h na sobnoj temperaturi (20°C - 25°C).
English: ANC was < 1 × 109/L and/or platelet count was < 50 × 109/La
Croatian: 9/l i/ili broj trombocita je bio < 50 × 10 9/l
English: Baseline characteristics were similar in the initial 218 patients randomised.
Croatian: Svih 218 randomiziranih bolesnika imalo je slične karakteristike u početku.
English: Dose modifications depending on duration of dosing interruption due to toxicity Duration of dosing interruption due to toxicity
Croatian: Tablica 4. Prilagodbe doze ovisno o trajanju prekida doziranja zbog toksičnosti
English: 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.
Croatian: 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.
English: 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).
Croatian: Premedikacija u svrhu smanjenja razina mokraćne kiseline i hidratacija preporučuju se prije doziranja u bolesnika s velikim tumorskim opterećenjem (vidjeti dio 4.2).
English: 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).
Croatian: 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).
English: • BESPONSA contains no bacteriostatic preservatives.
Croatian: • BESPONSA ne sadrži bakteriostatske konzervanse.
English: Pre-medication with a corticosteroid, antipyretic, and antihistamine is recommended prior to dosing (see section 4.4).
Croatian: Premedikacija s kortikosteroidom, antipiretikom i antihistaminikom preporučuje se prije doziranja (vidjeti dio 4.4).
English: If the reconstituted solution cannot be used immediately, it may be stored for up to 4 hours in a refrigerator (2 °C-8 °C).
Croatian: Ako se rekonstituirana otopina ne može odmah iskoristiti, može se čuvati najviše 4 sata u hladnjaku (2°C - 8°C).
English: For severe or life-threatening infusion reactions, treatment should be permanently discontinued (see section 4.2).
Croatian: U slučaju reakcija povezanih s infuzijom koje su teške ili opasne po život, potrebno je trajno prekinuti liječenje (vidjeti dio 4.2).