FrancophonIA/ELRC3.0 huggingface dataset:
English: IV infusion after reconstitution and dilution.
Croatian: i.v. infuzija nakon rekonstitucije i razrjeđivanja.
English: 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).
Croatian: 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).
English: If you need treatment with BESPONSA, you must stop breast-feeding during treatment and for at least 2 months after treatment.
Croatian: Ako Vam je potrebno liječenje lijekom BESPONSA, morate prestati dojiti tijekom liječenja i najmanje 2 mjeseca nakon završetka liječenja.
English: 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%).
Croatian: 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%).
English: Grade ≥ 2a non-haematological toxicity (BESPONSA-related)
Croatian: Nehematološka toksičnost stupnja a (povezana s primjenom lijeka BESPONSA)
English: Storage times and conditions for reconstituted and diluted BESPONSA solution
Croatian: Vremena i uvjeti čuvanja rekonstituirane i razrijeđene otopine lijeka BESPONSA
English: • 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.
Croatian: • 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.
English: 2-sided p-value = 0.0022
Croatian: p-vrijednost dvostranog testa = 0,0022
English: 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.
Croatian: 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).
English: For clinical management of hepatotoxicity, including VOD/SOS, see section 4.4.
Croatian: Za kliničko zbrinjavanje hepatotoksičnosti, uključujući VOD/SOS, vidjeti dio 4.4.
English: Activation of N-acetyl-gamma-calicheamicin dimethylhydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
Croatian: Aktiviranje N-acetil-gama-kalikeamicindimetilhidrazida uzrokuje lomove dvolančane DNK te potom uzrokuje zastoj staničnog ciklusa i apoptotsku smrt stanice.
English: 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).
Croatian: 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).
English: • 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.
Croatian: • Tijekom infuzije zaštitite intravensku vrećicu od svjetlosti pomoću navlake koja blokira ultraljubičaste zrake (tj. pomoću vrećica jantarne, tamnosmeđe ili zelene boje ili aluminijske folije).
English: Treatment should be permanently discontinued if VOD/SOS occurs (see section 4.2).
Croatian: Nužno je trajno prekinuti liječenje ako se pojavi VOD/SOS (vidjeti dio 4.2).
English: 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).
Croatian: 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).
English: 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).
Croatian: 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).
English: Your doctor will take regular blood tests to monitor your liver enzymes during treatment with BESPONSA.
Croatian: Liječnik će redovito provoditi krvne testove kako bi kontrolirao Vaše jetrene enzime tijekom liječenja lijekom BESPONSA.
English: 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.
Croatian: 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.
English: • infusion related reaction (see section 2); signs and symptoms include fever and chills or breathing problems during or shortly after the BESPONSA infusion.
Croatian: • reakcije povezane s infuzijom (vidjeti dio 2); znakovi i simptomi uključuju vrućicu, zimicu ili probleme s disanjem tijekom ili neposredno nakon infuzije lijeka BESPONSA.
English: [4.5 to 7.9]
Croatian: [3,9 do 5,8]
English: 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.
Croatian: 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.
English: 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).
Croatian: Ovisno o težini reakcije povezane s infuzijom, potrebno je razmotriti prekid infuzije ili primjenu steroida i antihistaminika (vidjeti dio 4.2).
English: For periodic monitoring of increased amylase and lipase, see section 4.4.
Croatian: Za periodično praćenje povišenih razina amilaze i lipaze vidjeti dio 4.4.
English: Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; VOD/SOS=venoocclusive disease/sinusoidal obstruction syndrome.
Croatian: Skraćenice: ALT=alanin-aminotransferaza; AST=aspartat-aminotransferaza; GGN=gornja granica normalne vrijednosti; VOD/SOS=venookluzivna bolest/sindrom sinusoidalne opstrukcije.
English: In the pivotal study (N=164), TLS, which may be life-threatening or fatal, was reported in 4/164 (2%) patients.
Croatian: U ključnom kliničkom ispitivanju (N=164) TLS, koji može biti opasan po život ili fatalan, je zabilježen u 4/164 (2%) bolesnika.
English: 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.
Croatian: 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.
English: • Your doctor will do blood tests during the treatment to check for side effects and for response to treatment.
Croatian: • Vaš liječnik će Vas slati na krvne pretrage tijekom liječenja kako bi provjeravao postoje li nuspojave ili odgovor na liječenje.
English: The dose of inotuzumab ozogamicin is administered based on body surface area (see section 4.2).
Croatian: Doza inotuzumab ozogamicina se primjenjuje ovisno o tjelesnoj površini (vidjeti dio 4.2).
English: • have signs and symptoms of an infusion related reaction, such as fever and chills or breathing problems during or shortly after the BESPONSA infusion.
Croatian: • imate znakove ili simptome reakcija povezanih s infuzijom, kao što su vrućica i zimica tijekom ili ubrzo nakon infuzije lijeka BESPONSA.
English: 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.
Croatian: 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.
English: The safety of immunisation with live viral vaccines during or following BESPONSA therapy has not been studied.
Croatian: Sigurnost provođenja imunizacije živim virusnim cjepivima tijekom ili nakon liječenja lijekom BESPONSA nije ispitivana.
English: 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.
Croatian: 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.
English: 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).
Croatian: Zbrinjavanje nekih nuspojava može zahtijevati prekide doziranja i/ili smanjenja doze, ili trajni prekid primjene lijeka BESPONSA (vidjeti dijelove 4.4 i 4.8).
English: Maximum time from reconstitution through the end of administration ≤ 8 hoursa Reconstituted solution
Croatian: Maksimalno vrijeme od rekonstitucije do kraja primjene ≤ 8 sati Rekonstituirana otopina
English: Any patients who do not achieve a CR/CRi within 3 cycles should discontinue treatment.
Croatian: U svakog bolesnika u kojeg unutar 3 ciklusa nije postignut CR/CRi treba prekinuti liječenje.
English: 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).
Croatian: 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).
English: • Reduced number of red blood cells which may result in fatigue and shortness of breath
Croatian: • Smanjen broj crvenih krvnih stanica, što može rezultirati umorom i nedostatkom zraka
English: For patients proceeding to a haematopoietic stem cell transplant (HSCT), the recommended duration of treatment is 2 cycles.
Croatian: Bolesnicima koji liječenje nastavljaju s transplantacijom hematopoetskih matičnih stanica (engl. haematopoietic stem cell transplant, HSCT) preporučuje se trajanje liječenja od 2 ciklusa.
English: Day 15a
Croatian: 15. dan
English: 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.
Croatian: 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.
English: 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.
Croatian: Stoga treba pažljivo razmotriti istodobnu primjenu inotuzumab ozogamicina i lijekova za koje je poznato da produljuju QT-interval ili koji izazivaju Torsades de Pointes.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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).
English: The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic product.
Croatian: Mala molekula N-acetil-gamakalikeamicin je citotoksični lijek.
English: The secondary endpoints included MRD negativity, duration of remission (DoR), HSCT rate, and progression-free survival (PFS).
Croatian: 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).
English: Inotuzumab ozogamicin was clastogenic in vivo in the bone marrow of male mice.
Croatian: Inotuzumab ozogamicin je bio klastogen in vivo u koštanoj srži mužjaka miševa.
English: If ANC decreases, interrupt the next cycle of treatment until recovery of ANC to ≥ 1 × 109/L.
Croatian: Ako se ABN smanjuje, prekinuti sljedeći ciklus liječenja do povratka ABN-a na ≥ 1 × 10
English: 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.
Croatian: 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.
English: [2.8 to 4.6] Hazard ratio [95% CI] = 0.471 [0.366-0.606] 2-sided p-value < 0.0001
Croatian: [2,8 do 4,6] Omjer hazarda [95% CI] = 0,471 [0,366-0,606] p-vrijednost dvostranog testa < 0,0001
English: • 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.
Croatian: • 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.
English: 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.
Croatian: Od 49 (15%) bolesnika s Ph ALL, 4 bolesnika nisu prethodno primili inhibitor tirozin kinaze (TKI), 28 bolesnika je primilo jedan
English: 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.
Croatian: 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.
English: In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide is a substrate of P-glycoprotein (P-gp).
Croatian: In vitro je N-acetil-gama-kalikeamicindimetilhidrazid supstrat P-glikoproteina (P-gp).
English: • Abnormally high levels of amylase (an enzyme needed for digestion and conversion of starch into sugars) in the blood
Croatian: • Abnormalno visoke razine amilaze (enzima koji je potreban za probavu i pretvaranje škroba u šećere) u krvi
English: After reconstitution (see section 6.6), 1 mL of solution contains 0.25 mg inotuzumab ozogamicin.
Croatian: Nakon rekonstitucije (vidjeti dio 6.6), 1 ml otopine sadrži 0,25 mg inotuzumab ozogamicina.
English: BESPONSA is for intravenous use.
Croatian: BESPONSA je za intravensku primjenu.
English: Table 5 shows the adverse reactions reported in patients with relapsed or refractory ALL who received BESPONSA.
Croatian: Tablica 5 prikazuje nuspojave zabilježene u bolesnika s recidivirajućom ili refraktornom ALL koji su primali lijek BESPONSA.
English: The co-primary endpoints were CR/CRi, assessed by a blinded independent endpoint adjudication committee (EAC), and overall survival (OS).
Croatian: Endpoint Adjudication Committee, EAC) su bili CR/CRi i ukupno preživljenje (engl. overall survival, OS).
English: 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.
Croatian: 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.
English: In repeat dose toxicity studies in rats and monkeys, female reproductive findings included atrophy of ovaries, uterus, vagina, and mammary gland.
Croatian: U ispitivanjima toksičnosti ponovljene doze u štakora i majmuna, reproduktivni nalazi u ženki su uključivali atrofiju jajnika, maternice, rodnice i mliječnih žlijezda.
English: 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.
Croatian: 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.
English: 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
Croatian: 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.
English: Formal carcinogenicity studies have not been conducted with inotuzumab ozogamicin.
Croatian: Nisu provedena posebna ispitivanja kancerogenosti s inotuzumab ozogamicinom.
English: a Severity grade according to National Cancer Institute Common Terminology Criteria for Adverse Events
Croatian: Stupanj težine prema Zajedničkim kriterijima terminologije za nuspojave Nacionalnog instituta za rak (engl.
English: N-acetyl-gamma-calicheamicin dimethylhydrazide (the cytotoxic agent released from inotuzumab ozogamicin) was mutagenic in an in vitro bacterial reverse mutation (Ames) assay.
Croatian: N-acetil-gama-kalikeamicindimetilhidrazid (citotoksična tvar koju otpušta inotuzumab ozogamicin) bio je mutagen u in vitro testu bakterijske reverzne mutacije (Amesov test).
English: 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%).
Croatian: 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%).
English: Grade ≥ 3 hyperbilirubinaemia and increased transaminases were reported in 9 (6%) and 11 (7%) patients, respectively.
Croatian: Hiperbilirubinemija ≥ 3. stupnja i povećana razina transaminaza bile su zabilježene u 9 (6%), odnosno 11 (7%) bolesnika.
English: 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).
Croatian: 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).
English: 2-sided p-value < 0.0001
Croatian: p-vrijednost dvostranog testa < 0,0001
English: No patients tested positive for neutralising anti-inotuzumab ozogamicin antibodies.
Croatian: Nijedan od bolesnika nije imao pozitivne nalaze testa na neutralizirajuća protutijela protiv inotuzumab ozogamicina.
English: 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).
Croatian: Smatra se da inotuzumab ozogamicin ima potencijal oštetiti reproduktivnu funkciju i plodnost u muškaraca i žena na temelju nekliničkih nalaza.
English: Increases in Grade ≥ 3 amylase and lipase were reported in 3 (2%) and 7 (4%) patients, respectively.
Croatian: Povećanja amilaze i lipaze ≥ 3. stupnja zabilježena su u 3 (2%), odnosno 7 (4%) bolesnika.
English: For storage conditions after reconstitution and dilution, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije i razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA (see section 4.2).
Croatian: Povećanje razina u nalazima jetrenih proba može zahtijevati privremeni prekid doziranja, smanjenje doze ili trajni prekid primjene lijeka BESPONSA (vidjeti dio 4.2).
English: Diluted solution After start of dilution
Croatian: Nakon početka razrjeđivanja
English: Type I amber glass vial with chlorobutyl rubber stopper and crimp seal with flip off cap containing 1 mg of powder.
Croatian: I boje jantara, s klorobutilnim gumenim čepom te prstenastim zatvaračem s flipoff kapicom, koja sadrži 1 mg praška.
English: ECG QT prolonged (1%) Increased amylase (5%)
Croatian: Produljeni QT-interval na EKG-u (1%) Povećane razine amilaze