natgillin/translations-raw huggingface dataset:
The safety and efficacy of BESPONSA were evaluated in a single-arm, open-label, multicentre Phase 1/2 study (Study 2).
Sigurnost i djelotvornost lijeka BESPONSA su ocijenjeni u otvorenom, multicentričnom ispitivanju Faze 1/2 s jednom skupinom (Ispitivanje 2).
Potential hepatobiliary disease should be evaluated and treated according to standard medical practice.
Potrebno je procijeniti moguću pojavu hepatobilijarne bolesti te je liječiti u skladu sa standardnom medicinskom praksom.
Women of childbearing potential should avoid becoming pregnant while receiving BESPONSA.
Žene reproduktivne dobi moraju izbjegavati trudnoću dok primaju lijek BESPONSA.
d VOD/SOS includes 1 additional patient with Venoocclusive liver disease that occurred at Day 56 with no intervening HSCT.
VOD/SOS uključuje 1 dodatnog bolesnika s venookluzivnom bolesti jetre koja se pojavila 56. dana bez interveniranja HSCT-om.
For full information on dosage and dose modifications please refer to the Summary of Product Characteristics.
Za potpune informacije o doziranju i prilagodbi doze molimo vidjeti sažetak opisa svojstava lijeka.
Febrile neutropenia, which may be life-threatening, was reported in 43 (26%) patients.
Febrilna neutropenija, koja može biti opasna po život, bila je zabilježena u 43 (26%) bolesnika.
• High levels of liver enzymes (which can be indicators of liver injury) in the blood
• Visoke razine jetrenih enzima (koje mogu biti pokazatelji oštećenja jetre) u krvi
BESPONSA is used to treat adults with acute lymphoblastic leukaemia.
BESPONSA se koristi za liječenje odraslih osoba koji boluju od akutne limfoblastične leukemije.
All patients were required to have ≥ 5% bone marrow blasts and to have received 1 or 2 prior induction chemotherapy regimens for ALL.
Svi bolesnici su trebali imati ≥ 5% blasta u koštanoj srži i već primiti 1 do 2 režima indukcijske kemoterapije za ALL.
BESPONSA is for single use only.
BESPONSA je namijenjena samo za jednokratnu primjenu.
What you need to know before you are given BESPONSA
Što morate znati prije nego počnete primjenjivati lijek BESPONSA
• If the medicine works well and you are going to receive a stem cell transplant (see section 2),
• Ako lijek dobro djeluje i Vi trebate ići na transplantaciju matičnih stanica (vidjeti dio 2),
[6.0 to 9.2]
[6,0 do 9,2]
Table 4 shows the dose modification guidelines depending on the duration of dosing interruptions due to toxicity.
Tablica 4 prikazuje smjernice za prilagodbu doze ovisno o trajanju prekida doziranja zbog toksičnosti.
Infusion related reactions generally occurred in Cycle 1 and shortly after the end of the inotuzumab ozogamicin infusion and resolved spontaneously or with medical management.
Reakcije povezane s infuzijom su se uglavnom javljale u 1. ciklusu i ubrzo nakon završetka infuzije inotuzumab ozogamicina te su bile riješene spontano ili uz medicinsko zbrinjavanje.
c Haemorrhage also includes other types of haemorrhage (17%).
Hemoragija uključuje i druge vrste hemoragija (17%).
Hepatotoxicity, including venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS)
Hepatotoksičnost, uključujući venookluzivnu bolest jetre/sindrom sinusoidalne opstrukcije (VOD/SOS)
Table 2 and Table 3 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
Tablica 2 i Tablica 3 prikazuju smjernice za prilagodbu doze za hematološke i nehematološke toksičnosti.
Complete blood counts should be monitored prior to each dose of BESPONSA and signs and symptoms of infection during treatment and after HSCT (see section 5.1), bleeding/haemorrhage, and other effects of myelosuppression should be monitored during treatment.
Potrebno je kontrolirati kompletnu krvnu sliku prije primjene svake doze lijeka BESPONSA te obratiti pažnju na znakove i simptome infekcije tijekom liječenja i nakon HSCT-a (vidjeti dio 5.1), krvarenja/hemoragije i druge učinke mijelosupresije tijekom liječenja.
By central and local laboratory tests, 231/253 (91.3%) patients and 130/253 (51.4%) patients, respectively, had ≥ 70% CD22-positive leukaemic blasts at baseline.
U testiranju u lokalnom i središnjem laboratoriju 231/253 (91,3%) bolesnika i 130/253 (51,4% bolesnika) imalo je ≥ 70% CD22-pozitivnih leukemijskih blasta na početku.
BESPONSA should not be administered as an intravenous push or bolus.
BESPONSA se ne smije primijeniti kao brza intravenska injekcija ili bolus.
The most common reasons for treatment discontinuation were: disease progression/relapse (30 [41.7%)], resistant disease (4 [5.6%]); HSCT (18 [25.0%]), and adverse events
Najčešći razlozi prekida liječenja bili su: progresija bolesti/recidiv (30 [41,7%], ustrajna bolest (4 [5,6%], HSCT (18 [25,0%] i štetni događaji (13 [18,1%]).
Patients should be observed during, and for at least 1 hour after the end of infusion for symptoms of infusion related reactions (see section 4.4).
Bolesnike treba promatrati tijekom infuzije i najmanje 1 sat nakon završetka infuzije zbog moguće pojave simptoma reakcija povezanih s primanjem infuzije (vidjeti dio 4.4).
This is consistent with the known induction of DNA breaks by calicheamicin.
Ovo je u skladu s poznatom indukcijom DNK lomova od strane kalikeamicina.
Among the 79 patients who proceeded to a subsequent HSCT (8 of whom received additional salvage therapy after treatment with BESPONSA before proceeding to HSCT), VOD/SOS was reported in 18 (23%) patients.
Od 79 bolesnika u kojih je naknadno napravljen HSCT (od kojih je 8 primilo dodatnu „terapiju spasa“ nakon liječenja lijekom BESPONSA prije HSCT-a), VOD/SOS je prijavljen u 18 (23%) bolesnika.
Abbreviation: ANC=absolute neutrophil count.
Skraćenica: ABN=apsolutni broj neutrofila.
If further dose modification is required, then reduce the number of doses to 2 per cycle for subsequent cycles.
Ako je potrebna daljnja prilagodba doze, u sljedećim ciklusima smanjiti broj doza na 2 po ciklusu.
Fatal infections, including pneumonia, neutropenic sepsis, sepsis, septic shock, and pseudomonal sepsis, were reported in 8 (5%) patients.
Fatalne infekcije, uključujući upalu pluća, neutropeničnu sepsu, sepsu, septični šok i sepsu povezanu s bakterijama Pseudomonas, su zabilježene u 8 (5%) bolesnika.
In patients who tested positive for anti-inotuzumab ozogamicin antibodies, no effect on clearance of BESPONSA was detected based on population-pharmacokinetic analysis.
U bolesnika koji su imali pozitivne nalaze testa na protutijela protiv inotuzumab ozogamicin nije primijećen nikakav učinak na klirens lijeka BESPONSA na temelju populacijske farmakokinetičke analize.
Based on a population pharmacokinetic analysis in 765 patients, body surface area was found to significantly affect inotuzumab ozogamicin disposition.
Na temelju populacijske farmakokinetičke analize u 765 bolesnika, zaključeno je da tjelesna površina značajno utječe na dispoziciju inotuzumab ozogamicina.
• QT interval prolongation (see section 2); signs and symptoms include a change in electrical activity of the heart that can cause serious irregular heart rhythms.
• produljenja QT-intervala (vidjeti dio 2); znakovi i simptomi uključuju promjenu električne aktivnosti srca koja može uzrokovati ozbiljne nepravilne srčane ritmove.
Permanently discontinue treatment (see section 4.4).
Trajno prekinuti liječenje (vidjeti dio 4.4)
Following administration of multiple doses, a 5.3 times accumulation of inotuzumab ozogamicin was observed between Cycles 1 and 4.
Nakon primjene višestrukih doza zabilježena je 5,3 puta veća akumulacija inotuzumab ozogamicina između 1. i 4. ciklusa.
Because of the potential for adverse reactions in breast-fed children, women must not breast-feed during treatment with BESPONSA and for at least 2 months after the final dose (see section 5.3).
Zbog mogućih nuspojava u dojenčadi, žene ne smiju dojiti tijekom liječenja lijekom BESPONSA i najmanje 2 mjeseca nakon zadnje doze (vidjeti dio 5.3).
A third cycle may be considered for those patients who do not achieve a CR/CRi and MRD negativity after 2 cycles.
Treći ciklus može se uzeti u obzir u onih bolesnika koji ne postignu CR/CRi i negativan status MRD-a nakon 2 ciklusa.
- Protect from light.
- Zaštititi od svjetlosti.
Protect from light and do not freeze.
Zaštititi od svjetlosti i ne zamrzavati.
Patients should be monitored for signs and symptoms of TLS and treated according to standard medical practice.
Bolesnike je potrebno pratiti radi znakova i simptoma TLS-a te liječiti u skladu sa standardnom medicinskom praksom.
Based on non-clinical safety findings, inotuzumab ozogamicin can cause embryo-foetal harm when administered to a pregnant woman.
Na temelju nekliničkih sigurnosnih rezultata, inotuzumab ozogamicin može imati štetan učinak na embrio-fetalni razvoj kada se daje trudnici.
Of 93 screened patients, 72 patients were assigned to study drug and treated with BESPONSA.
Od 93 bolesnika u probiru, 72 bolesnika je dodijeljeno na ispitivani lijek i liječeno lijekom BESPONSA.
Careful consideration is required before administering BESPONSA to patients who have had a prior HSCT.
Potrebno je pažljivo razmatranje prije primjene lijeka BESPONSA u bolesnika u kojih je već proveden HSCT.
Common Increased lipase (9%)
Povećane razine lipaze (9%)
Dosing regimen for Cycle 1 All patients: Dose (mg/m2) Cycle length
Režim doziranja za 1. ciklus Svi bolesnici: Doza (mg/m Trajanje ciklusa
Alternatively, CD22 expression was assessed using immunohistochemistry in patients with an inadequate bone marrow aspirate and insufficient circulating blasts.
Alternativno se ekspresija CD22 procjenjivala imunohistokemijski u bolesnika s nedostatnim uzorkom aspirata koštane srži i nedostatnim cirkulirajućim blastima.
Due to the risk of VOD/SOS, for patients proceeding to HSCT, the recommended duration of treatment with inotuzumab ozogamicin is 2 cycles; a third cycle may be considered for those patients who do not achieve a CR or CRi and MRD negativity after 2 cycles (see section 4.2).
Zbog rizika od VOD/SOS-a, u bolesnika koji nastavljaju s HSCT-om preporučeno trajanje liječenja inotuzumab ozogamicinom je 2 ciklusa; treći ciklus se može uzeti u obzir u onih bolesnika koji ne postignu CR ili CRi i negativan status MRD-a nakon 2 ciklusa (vidjeti dio 4.2).
• Gently invert the infusion container to mix the diluted solution.
• Nježno preokrenite spremnik za infuziju kako bi se promiješala razrijeđena otopina.
No patients with relapsed or refractory ALL who were treated with BESPONSA in clinical trials had undergone HSCT within the previous 4 months.
Nijedan bolesnik s recidivirajućom ili refraktornom ALLliječen lijekom BESPONSA u kliničkim ispitivanjima nije podvgrnut HSCT-u u zadnja 4 mjeseca.
Bleeding/haemorrhage
Krvarenje/hemoragija
Treatment with BESPONSA may prolong QT interval (a change in electrical activity of the heart that can cause serious irregular heart rhythms).
Liječenje lijekom BESPONSA može produljiti QT interval (promjena električne vodljivosti srca koja može uzrokovati ozbiljne nepravilne srčane ritmove).
Management of severe infection, bleeding/haemorrhage and other effects of myelosuppression, including severe neutropenia or thrombocytopenia, may require a dosing interruption, dose reduction, or discontinuation of treatment (see section 4.2).
Zbrinjavanje teške infekcije, krvarenja/hemoragije i drugih učinaka mijelosupresije, uključujući tešku neutropeniju ili trombocitopeniju, može zahtijevati privremeni prekid doziranja, smanjenje doze ili prekid liječenja (vidjeti dio 4.2).
Depending on the severity of the infusion related reaction, consider discontinuation of the infusion or administration of steroids and antihistamines.
Ovisno o težini reakcije povezane s infuzijom, razmotriti prekid infuzije ili primjenu steroida i antihistaminika.
Patients with Ph+ B-cell precursor ALL were required to have failed treatment with at least 1 second or third generation TKI and standard chemotherapy.
Bolesnici s Ph+ ALL prekursora B limfocita su trebali imati neuspjelo liječenje s barem 1 TKI-om druge ili treće generacije i standardnom kemoterapijom.
Of the 5 patients who experienced VOD/SOS during treatment with inotuzumab ozogamicin but without an intervening HSCT, 2 patients had also received an HSCT before BESPONSA treatment.
Od 5 bolesnika koji su doživjeli VOD/SOS tijekom liječenja inotuzumab ozogamicinom, ali bez HSCT intervencije, 2 bolesnika su prije liječenja lijekom BESPONSA prošli i HSCT.
The mean (SD) maximum serum concentration (Cmax) of inotuzumab ozogamicin was 308 ng/mL (362).
Srednja vrijednost (SD) maksimalne koncentracije u serumu (Cmax) inotuzumab ozogamicina je iznosila 308 ng/ml (362).
The median age was 45 years (range 20-79); 76.4% were Salvage status ≥ 2; 31.9% had received a prior HSCT and 22.2% were Ph+.
Medijan dobi je bio 45 godina (raspon 20-79); 76,4% su imali status spašavanja ≥2; 31,9% je prethodno prošlo HSCT i 22,2% njih je imalo Ph+ kromosom.
In clinical studies of BESPONSA in patients with relapsed or refractory ALL, 7/236 (3%) patients tested positive for anti-inotuzumab ozogamicin antibodies.
U kliničkim ispitivanjima lijeka BESPONSA u bolesnika s recidivirajućom ili refraktornom ALL, 7/236 (3%) bolesnika su imali pozitivne nalaze testa na protutijela protiv inotuzumab ozogamicina.
In the Phase 2 portion of the study, patients had to have received at least 2 prior treatment regimens for ALL and patients with Ph+ B-cell ALL had to have failed treatment with at least 1 TKI.
U dijelu ispitivanja faze II bolesnici su trebali primiti najmanje 2 prethodna režima liječenja za ALL, a bolesnici s Ph+ B-staničnim ALL-om trebali su imati neuspješno liječenje najmanje jednim TKI-om.
ECG and electrolytes should be obtained prior to the start of treatment and periodically monitored during treatment (see sections 4.8 and 5.2).
Potrebno je napraviti nalaze EKG-a i elektrolita prije početka liječenja te ih periodički pratiti tijekom liječenja (vidjeti dijelove 4.8 i 5.2).
If an infusion related reaction occurs, the infusion should be interrupted and appropriate medical management should be instituted.
Ako se pojavi reakcija povezana s infuzijom, potrebno je prekinuti infuziju i započeti s odgovarajućim medicinskim zbrinjavanjem.
The mean (SD) simulated total area under the concentration-time curve (AUC) per cycle at steady state was 100 mcgh/mL (32.9).
Srednja vrijednost (SD) simulirane ukupne površine pod krivuljom (AUC) koncentracija-vrijeme po ciklusu u stanju dinamičke ravnoteže iznosila je 100 µgh/ml (32,9).
In the pivotal clinical study (N=164), VOD/SOS was reported in 23 (14%) patients including 5 (3%) patients during study therapy or in follow-up without an intervening HSCT.
U ključnom kliničkom ispitivanju (N=164) VOD/SOS je prijavilo 23 (14%) bolesnika uključujući 5 (3%) bolesnika tijekom primjene ispitivane terapije ili u periodu praćenja bez HSCT intervencije.
≥ 14 days
≥ 14 dana
Slight foetal growth retardation in rats also occurred at approximately 0.4 times the human clinical exposure based on AUC (see section 4.6).
Neznatno usporavanje fetalnog rasta u štakora se isto tako dogodilo i pri izloženosti koja je bila približno 0,4 puta veća od kliničke izloženosti u ljudi na temelju AUC (vidjeti dio 4.6).
In patients in whom the serum bilirubin is ≥ ULN prior to HSCT, HSCT post BESPONSA treatment should only be undertaken after careful consideration of the benefit/risk.
U bolesnika u kojih je razina bilirubina u serumu ≥ GGN prije HSCT-a, smije se nastaviti s HSCT-om poslije liječenja lijekom BESPONSA samo nakon pažljivog razmatranja koristi i rizika.
The maternally toxic dose (approximately 2.3 times the human clinical exposure based on AUC) also resulted in foetal growth retardation, including decreased foetal weights and delayed skeletal ossification.
Toksična maternalna doza (približno 2,3 puta veća od kliničke izloženosti u ljudi na temelju AUC) je isto tako rezultirala usporavanjem fetalnog rasta, uključujući smanjenu fetalnu težinu i zakašnjelu osifikaciju skeleta.
Population pharmacokinetic/pharmacodynamic evaluation suggested a correlation between increasing inotuzumab ozogamicin serum concentrations and prolongation of QTc intervals in ALL and non-Hodgkin's lymphoma (NHL) patients.
Populacijska farmakokinetička/farmakodinamička procjena ukazala je na korelaciju između povećanja koncentracije inotuzumab ozogamicina u serumu i produljenja QTc-intervala u bolesnika s ALL-om i non-Hodgkinovim limfomom (NHL).
In humans, serum N-acetyl-gamma-calicheamicin dimethylhydrazide levels were typically below the limit of quantitation (50 pg/mL), but sporadic measurable levels of unconjugated calicheamicin up to 276 pg/mL occurred in some patients.
U ljudi su razine N-acetil-gama-kalikeamicindimetilhidrazida u serumu obično ispod granice kvantifikacije (50 pg/ml), ali u nekih su se bolesnika povremeno pojavile mjerljive razine nekonjugiranog kalikeamicina do 276 pg/ml.
• have elevations in amylase or lipase enzymes that may be a sign of problems with your pancreas or liver and gallbladder or bile ducts.
• imate povišene razine enzima amilaze ili lipaze koje mogu biti znak problema s gušteračom ili jetrom i žučnim mjehurom ili žučnim vodovima.
If these patients do proceed to HSCT, signs and symptoms of VOD/SOS should be monitored closely (see section 4.2).
Ako ovi bolesnici ipak nastave s HSCT-om, treba obratiti posebnu pažnju na znakove i simptome VOD/SOS-a (vidjeti dio 4.2).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING VIAL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
• If the medicine works well, but you are not going to receive a stem cell transplant (see section
• Ako lijek dobro djeluje, ali Vi nećete ići na transplantaciju matičnih stanica (vidjeti dio 2),
Tumour lysis syndrome (2%) Hyperuricaemia (4%)
Sindrom lize tumora (2%) Hiperuricemija (4%)
In 234 patients with relapsed or refractory ALL, the clearance of inotuzumab ozogamicin at steady state was 0.0333 L/h, and the terminal elimination half-life (t½) at the end of Cycle 4 was approximately 12.3 days.
U 234 bolesnika s recidivirajućom ili refraktornom ALL klirens inotuzumab ozogamicina u stanju dinamičke ravnoteže iznosio je 0,0333 l/h, a terminalni poluvijek eliminacije (t½) na kraju 4. ciklusa bio je oko 12,3 dana.
Table 8 shows the storage times and conditions for reconstitution, dilution, and administration of BESPONSA.
Tablica 8 prikazuje vremena čuvanja i uvjete za rekonstituciju, razrjeđivanje i primjenu lijeka BESPONSA.
BESPONSA should be administered with caution in patients who have a history of, or predisposition to QT interval prolongation, who are taking medicinal products that are known to prolong QT interval (see section 4.5) and in patients with electrolyte disturbances.
Lijek BESPONSA treba primjenjivati uz oprez u bolesnika koji imaju povijest ili predispoziciju za produljenje QT-intervala, primaju lijekove za koje je poznato da produljuju QT-interval (vidjeti dio 4.5) te u bolesnika s poremećajima elektrolita.
BESPONSA significantly increased the risk of VOD/SOS above that of standard chemotherapy regimens in this patient population.
U ovoj populaciji bolesnika BESPONSA značajno povećava rizik od VOD/SOS-a iznad onog standardnih režima kemoterapije.
• have a history of, or tendency to have, QT interval prolongation (a change in electrical activity of the heart that can cause serious irregular heart rhythms), are taking medicines that are known to prolong QT interval, and/or have abnormal electrolyte (e.g., calcium, magnesium, potassium) levels.
• ste već imali ili ste skloni produljenju QT-intervala (promjena u električnoj aktivnosti srca koja može prouzrokovati ozbiljne nepravilne srčane ritmove), uzimate lijekove za koje je poznato da produljuju QT-interval i/ili imate poremećaj razine elektrolita (npr. kalcija, magnezija, kalija).
Administration of inotuzumab ozogamicin to female rats at the maternally toxic dose (approximately 2.3 times the human clinical exposure based on AUC) prior to mating and during the first week of gestation resulted in embryo-foetal toxicity, including increased resorptions and decreased viable embryos.
Primjena inotuzumab ozogamicina u ženki štakora u maternalno toksičnoj dozi (približno 2,3 puta veće od kliničke izloženosti u ljudi na temelju AUC) prije parenja i tijekom prvog tjedna gestacije je rezultirala embrio-fetalnom toksičnošću, uključujući povećane resorpcije i smanjeni broj vijabilnih embrija.
• have serious ongoing liver disease, e.g., cirrhosis (a condition in which the liver does not function properly due to long-term damage), nodular regenerative hyperplasia (a condition with signs and symptoms of portal hypertension that can be caused by chronic use of medicines), active hepatitis (a disease characterised by inflammation of the liver).
• ako trenutno bolujete od ozbiljne bolesti jetre, npr. ciroze (stanja u kojem jetra ne funkcionira kako bi trebala zbog dugotrajnog oštećenja), nodularne regenerativne hiperplazije (stanja sa znakovima i simptomima portalne hipertenzije koje može biti izazvano stalnim uzimanjem lijekova), aktivnog hepatitisa (bolesti koju karakterizira upala jetre).
Interrupt treatment until recovery to Grade 1 or pre-treatment grade levels prior to each dose.
Prije svake doze, prekinuti liječenje do povratka na 1. stupanj ili razinu stupnja prije liječenja.
No Grade ≥ 3 QT interval prolongation or events of Torsades de Pointes were reported.
Nisu zabilježena produljenja QT-intervala ≥ 3. stupnja ili slučajevi Torsades de Pointes.
Among all 326 randomised patients, the survival probability at 24 months was 22.8% in the BESPONSA arm and 10% in the Investigator's choice of chemotherapy arm.
Među svih 326 randomiziranih bolesnika je vjerojatnost preživljenja nakon 24 mjeseca bila 22,8% u skupini s lijekom BESPONSA te 10% u skupini s kemoterapijom po izboru ispitivača.
TLS occurred shortly after the end of the inotuzumab ozogamicin infusion and resolved with medical management.
TLS se pojavio ubrzo nakon završetka infuzije inotuzumab ozogamicina te je bio riješen medicinskim zbrinjavanjem.
No adjustment to the starting dose is required in patients with hepatic impairment defined by total bilirubin ≤ 1.5 × upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (see section 5.2).
Nije potrebna prilagodba početne doze u bolesnika s oštećenjem jetre koje je definirano ukupnim bilirubinom ≤ 1,5 × GGN (gornja granica normale) i aspartat aminotransferazom (AST)/ alanin aminotransferazom (ALT) ≤ 2,5 × GGN (vidjeti dio 5.2).
The safety and efficacy of BESPONSA have not been studied in patients with end-stage renal disease.
Sigurnost i djelotvornost lijeka BESPONSA nisu ispitivane u bolesnika sa završnim stadijem bubrežne bolesti.
In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati (ili navesti) u zdravstvenom kartonu bolesnika.
≥ 7 days
≥ 7 dana
In toxicity studies, rats developed oval cell hyperplasia, altered hepatocellular foci, and hepatocellular adenomas in the liver at approximately 0.3 times the human clinical exposure based on AUC.
U ispitivanjima toksičnosti, štakori su razvili hiperplaziju ovalnih stanica, izmijenjena hepatocelularna žarišta i hepatocelularne adenome u jetri pri izloženosti dozama koje su približno 0,3 puta veće od kliničke izloženosti u ljudi na temelju AUC.
Febrile neutropenia (26%) Neutropenia (49%) Thrombocytopenia (51%) Leukopenia (35%) Lymphopenia (18%) Anaemia (36%)
Febrilna neutropenija (26%) Neutropenija (49%) Trombocitopenija (51%) Leukopenija (35%) Limfopenija (18%) Anemija (36%)
For instructions on reconstitution and dilution of BESPONSA before administration, see section 6.6.
Za upute o rekonstituciji i razrjeđivanju lijeka BESPONSA prije primjene vidjeti dio 6.6.
Inotuzumab ozogamicin pharmacokinetics were well characterised by a 2-compartment model with linear and time-dependent clearance components.
Farmakokinetika inotuzumab ozogamicina je bila dobro predočena modelom s 2 odjeljka s linearnim i komponentama klirensa koje su ovisne o vremenu.
Sucrose Polysorbate 80 Sodium chloride Tromethamine
saharoza polisorbat 80 natrijev klorid trometamin