natgillin/translations-raw huggingface dataset:
In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide and gemtuzumab ozogamicin had a low potential to inhibit the activities of CYP1A2, CYP2A6 (tested only using gemtuzumab ozogamicin), CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5 at clinically relevant concentrations. 
In vitro su N-acetil-gama-kalikeamicindimetilhidrazid i gemtuzumab ozogamicin imali nizak potencijal za inhibiciju aktivnosti CYP1A2, CYP2A6 (testirano samo uz primjenu gemtuzumab ozogamicina), CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 i CYP3A4/5 u klinički relevantnim koncentracijama.
N per study (range) 
Broj po ispitivanju (raspon)
daunorubicin cytarabine 
daunorubicin citarabin
Infusion lines made of PVC (DEHP- or non DEHP-containing), or polyethylene are recommended. 
Preporučuju se cjevčice za infuziju napravljene od PVC-a (koji sadrži DEHP ili koji ne sadrži DEHP) ili polietilena.
Nausea Stomatitisp 
• loša probava
Management of signs or symptoms of hepatic toxicity may require a dose interruption, or discontinuation of MYLOTARG (see section 4.2). 
Zbrinjavanje znakova ili simptoma jetrene toksičnosti može zahtijevati privremeni prekid doziranja ili trajni prekid liječenja lijekom MYLOTARG (vidjeti dio 4.2).
MYLOTARG should not be given if you: 
Nemojte primiti MYLOTARG:
In the combination therapy study in patients with previously untreated de novo AML treated with fractionated doses of gemtuzumab ozogamicin in combination with chemotherapy, Grade 3/4 decreases in leukocytes, neutrophils, and platelets were observed in 131 (100%), 124 (96.1%), and 131 (100%) patients, respectively. 
U ispitivanju kombiniranog liječenja provedenog na bolesnicima s prethodno neliječenim de novo AML-om, koji su liječeni podijeljenim dozama gemtuzumab ozogamicina u kombinaciji s kemoterapijom, smanjenja stupnja 3/4 u broju leukocita zabilježena su kod 131 (100 %), u broju neutrofila kod 124 (96,1 %) te u broju trombocita kod 131 (100 %) bolesnika.
Hepatotoxicity, including life-threatening, and sometimes fatal hepatic failure and VOD/SOS have been reported in patients treated with MYLOTARG (see section 4.8). 
Hepatotoksičnost, uključujući po život opasno zatajenje jetre ponekad sa smrtnim ishodom, i venookluzivna bolest jetre (VOD) / sindrom sinusoidalne opstrukcije (engl. sinusoidal obstruction syndrome, SOS) prijavljeni su u bolesnika liječenih lijekom MYLOTARG (vidjeti dio 4.8).
• The other ingredients are dextran 40, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous. 
• Druge pomoćne tvari su: dekstran 40, saharoza, natrijev klorid, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat, bezvodni.
The efficacy of MYLOTARG has been shown in AML patients with favourable- and intermediate-risk cytogenetics, with uncertainty regarding the size of the effect in patients with adverse cytogenetics (see section 5.1). 
Djelotvornost lijeka MYLOTARG je utvrđena u bolesnika koji boluju od AML-a s povoljnom citogenetikom i citogenetikom intermedijarnog rizika, dok u bolesnika s lošom citogenetikom postoji nesigurnost vezano uz razinu učinka (vidjeti dio 5.1).
In a randomised study (COG AAML0531) that evaluated standard chemotherapy alone or combined with MYLOTARG in 1,063 newly diagnosed children with AML (93.7% of patients < 18 years of age), and young adults (6.3% of patients); mean age was 8.9 years (range: 0-29 years), patients with de novo AML were randomly assigned to either standard 5-course chemotherapy alone or to the same chemotherapy with 2 doses of MYLOTARG (3 mg/m2/dose) administered once in induction Course 1 and once in intensification Course 2. 
U randomiziranom ispitivanju (COG AAML0531) koje je procjenjivalo standardnu kemoterapiju zasebno ili u kombinaciji s lijekom MYLOTARG u 1063 novodijagnosticirane djece s AML-om (93,7 % bolesnika u dobi od < 18 godina) i mlađih odraslih (6,3 % bolesnika); srednja dob iznosila je 8,9 godina (raspon: 0 - 29 godina), bolesnici s de novo AML-om randomizirani su u skupinu koja je primala samo standardnu kemoterapiju u 5 ciklusa ili tu istu kemoterapiju s 2 doze lijeka MYLOTARG (3 mg/m2 po dozi) primijenjenu jedanput u uvodnom ciklusu 1 i jedanput u intenzifikacijskom ciklusu 2.
The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, haemorrhage and infection. 
Najčešće (≥ 1%) nuspojave koje su dovele do trajnog prekida u ispitivanju kombiniranog liječenja bile su trombocitopenija, VOD, hemoragija i infekcija.
Complete blood counts should be monitored prior to each dose of MYLOTARG. 
Prije svake doze lijeka MYLOTARG potrebno je kontrolirati kompletnu krvnu sliku.
b. Based on the Cox Proportional Hazards Model Versus daunorubicin+cytarabine. 
Na temelju Coxovog modela proporcionalnih hazarda naspram daunorubicina + citarabin.
Use in patients with hepatic impairment 
Primjena u bolesnika s oštećenjem bubrega
After gemtuzumab ozogamicin binds to the target it is internalised and N-acetyl calicheamicin is released by hydrolytic cleavage. 
Nakon što se gemtuzumab ozogamicin veže na ciljno mjesto slijedi njegov unos, a N-acetil kalikeamicin se otpušta hidrolitičkim cijepanjem.
Haemoglobin decreased Platelets decreased White blood cells decreased Lymphocytes (absolute) decreased 
Smanjen broj trombocita Smanjen broj leukocita Smanjenje (apsolutnog) broja limfocita
MYLOTARG + daunorubicin + cytarabine daunorubicin + cytarabine 
MYLOTARG + daunorubicin + citarabin daunorubicin + citarabin
MYLOTARG has not been studied in patients with severe renal impairment. 
MYLOTARG nije ispitivan u bolesnika s teškim oštećenjem bubrega.
l. Hypotension includes the following reported PTs: Hypotension and Blood pressure decreased. 
Hipotenzija uključuje sljedeće zabilježene preporučene pojmove: hipotenzija i sniženi krvni tlak.
Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate anhydrous 
Natrijev dihidrogenfosfat hidrat Natrijev hidrogenfosfat, bezvodni
In toxicity studies, rats developed preneoplastic lesions (minimal to slight oval cell hyperplasia) in the liver approximately 54 times, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168). 
U ispitivanjima toksičnosti štakori su razvili preneoplastične lezije (minimalnu do blagu hiperplaziju ovalnih stanica) u jetri pri izloženosti približno 54 puta većoj od kliničke izloženosti ljudi nakon treće doze od 3 mg/m na temelju vrijednosti AUC168.
• Liver problems 
• Problemi s jetrom
Amber Type 1 glass vial, with butyl rubber stopper and crimp seal with flip-off cap containing 5 mg gemtuzumab ozogamicin. 
I boje jantara, s butilnim gumenim čepom te prstenastim zatvaračem s flip-off kapicom sadrži 5 mg gemtuzumab ozogamicina.
In patients with hyperleukocytic (leukocyte count ≥ 30,000/mm3) AML, cytoreduction is recommended either with leukapheresis, oral hydroxyurea or AraC with or without hydroxyurea to reduce the peripheral white blood cell (WBC) count 48 hours prior to administration of MYLOTARG. 
3) preporučuje se citoredukcija leukaferezom, peroralnom hidroksiurejom ili AraC-om s hidroksiurejom ili bez nje, kako bi se smanjio broj leukocita u perifernoj krvi 48 sati prije primjene lijeka MYLOTARG.
Male reproductive effects (testes, epididymides, seminal vesicles) in monkeys were observed at approximately 66 times the human clinical exposure after the third dose of 3 mg/m2). 
Učinci na reproduktivni sustav mužjaka majmuna (testise, epididimise, sjemenske mjehuriće) zabilježeni su pri izloženosti približno 66 puta većoj od kliničke izloženosti ljudi nakon treće doze od 3 mg/m
For patients experiencing a complete remission (CR) following induction, defined as fewer than 5% blasts in a normocellular marrow and an absolute neutrophil count (ANC) of more than 1.0 × 109 cells/L with a platelet count of 100 × 109/L or more in the peripheral blood in the absence of transfusion, up to 2 consolidation courses of intravenous DNR (60 mg/m2 for 1 day [first course] or 2 days [second course]) in combination with intravenous AraC (1 g/m2 per 12 hours, infused over 2 hours on Day 1 to Day 4) with intravenous MYLOTARG (3 mg/m2/dose infused over 2 hours up to a maximum dose of one 5 mg vial on Day 1) are recommended. 
9 po litri ili više u perifernoj krvi u odsutnosti transfuzije, preporučuju se do 2 ciklusa konsolidacije uz intravensku primjenu DNRa (60 mg/m2 u trajanju od 1 dan [prvi ciklus] ili 2 dana [drugi ciklus]) u kombinaciji s intravenski primijenjenim AraC-om (1 g/m2 na 12 sati, infundiranim tijekom 2 sata od 1. do 4. dana) s intravenskom primjenom lijeka MYLOTARG (3 mg/m2 po dozi infundiranim tijekom 2 sata do maksimalne doze od jedne bočice od 5 mg 1. dana).
AML with adverse-risk cytogenetics 
AML s lošim citogenetskim rizikom
Store the vial in the original carton to protect from light. 
Čuvati bočicu u originalnoj kutiji radi zaštite od svjetlosti.
m. Hypertension includes the following reported PTs: Hypertension and Blood pressure increased. 
Hipertenzija uključuje sljedeće zabilježene preporučene pojmove: hipertenzija i povišeni krvni tlak.
Management of patients with severe infection, bleeding/haemorrhage, or other effects of myelosuppression, including severe neutropenia or persistent thrombocytopenia, may require a dose delay or permanent discontinuation of MYLOTARG (see sections 4.2 and 4.4). 
Liječenje bolesnika s teškom infekcijom, krvarenjem/hemoragijom ili drugim učincima mijelosupresije, uključujući tešku neutropeniju ili perzistirajuću trombocitopeniju, može zahtijevati odgađanje doziranja ili trajni prekid liječenja lijekom MYLOTARG (vidjeti dijelove 4.2 i 4.4).
Schedule modification for hyperleukocytosis 
Promjena rasporeda kod hiperleukocitoze
In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide is primarily metabolised via nonenzymatic reduction. 
In vitro se N-acetil-gama-kalikeamicindimetilhidrazid prvenstveno metabolizira putem neenzimske redukcije.
Management of patients with severe infection, bleeding/haemorrhage, or other effects of myelosuppression, including severe neutropenia or persistent thrombocytopenia, may require a dose delay or permanent discontinuation of MYLOTARG (see section 4.2). 
Liječenje bolesnika s teškom infekcijom, krvarenjem/hemoragijom ili drugim učincima mijelosupresije, uključujući tešku neutropeniju ili perzistirajuću trombocitopeniju, može zahtijevati odgađanje doziranja ili trajni prekid liječenja lijekom MYLOTARG (vidjeti dio 4.2).
If the product cannot be used immediately, the diluted solution may be stored up to 18 hours in a refrigerator (2°C-8°C) from the time of initial vial puncture with not more than 6 hours at room temperature (below 25°C). 
Ako se lijek ne može upotrijebiti odmah, razrijeđena otopina može se čuvati u hladnjaku (2 °C - 8 °C) do 18 sati od vremena početnog probijanja bočice uz najviše 6 sati na sobnoj temperaturi (ispod 25 °C).
c. Neutropenia includes the following reported PTs: Neutropenia, Granulocytopenia and Neutrophil count decreased. 
Neutropenija uključuje sljedeće zabilježene preporučene pojmove: neutropenija, granulocitopenija i smanjen broj neutrofila.
The primary metabolic pathway of gemtuzumab ozogamicin is anticipated to be hydrolytic release of N acetyl gamma calicheamicin dimethyl hydrazide. 
Očekuje se da je primarni metabolički put gemtuzumab ozogamicina hidrolitičko otpuštanje N-acetil-gama-kalikeamicindimetilhidrazida.
Each vial of powder for concentrate for solution for infusion contains 5 mg gemtuzumab ozogamicin. 
Jedna bočica praška za koncentrat za otopinu za infuziju sadrži 5 mg gemtuzumab ozogamicina.
(13.0%), Upper respiratory tract infection (4.3%), Bacterial infection (3.6%), Viral infection (24.2%), Gastrointestinal infection (3.3%), Skin infection (7.9%), and Other infections (19.5%). 
Infekcija uključuje sepsu i bakterijemiju (25,6 %), gljivičnu infekciju (10,5 %), infekciju donjih dišnih puteva (13,0 %), infekciju gornjih dišnih puteva (4,3 %), bakterijsku infekciju (3,6 %), virusnu infekciju (24,2 %), gastrointestinalnu infekciju (3,3 %), kožnu infekciju (7,9 %) i druge infekcije (19,5 %).
Postpone MYLOTARG until recovery of total bilirubin to ≤ 2 × ULN and AST and ALT to 
Odgodite liječenje lijekom MYLOTARG dok se ukupni bilirubin ne vrati na ≤ 2 × GGN, a AST i ALT na ≤ 2,5 × GGN prije svake doze.
In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide and gemtuzumab ozogamicin had a low potential to induce the activities of CYP1A2, CYP2B6, and CYP3A4 at clinically relevant concentrations. 
In vitro su N-acetil-gama-kalikeamicindimetilhidrazid i gemtuzumab ozogamicin imali nizak potencijal za indukciju aktivnosti CYP1A2, CYP2B6 i CYP3A4 u klinički relevantnim koncentracijama.
3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 3, 6, and 9 
3 mg/m2 po dozi (do maksimalno jedne bočice od 5 mg) 3., 6. i 9. dana
MYLOTARG 5 mg powder for concentrate for solution for infusion gemtuzumab ozogamicin 
MYLOTARG 5 mg prašak za koncentrat za otopinu za infuziju gemtuzumab ozogamicin
Interactions with other medicinal products 
Interakcije lijekova
• If platelet count recovers to < 100,000/mm3 and ≥ 50,000/mm3 within 14 days following the planned start date of the consolidation course: MYLOTARG should not be re-introduced and consolidation therapy should consist of DNR and AraC only. 
3 u roku od 14 dana nakon planiranog datuma početka ciklusa konsolidacije: MYLOTARG se ne smije ponovno uvesti, a terapija konsolidacije smije se sastojati samo od DNR-a i AraC-a.
The diluted solution can be refrigerated at 2°C-8°C for up to 12 hours. 
Razrijeđena otopina može se čuvati u hladnjaku na 2 °C - 8 °C do 12 sati.
The mITT population included all patients who were randomised, unless withdrawal of consent prior to start of treatment and were analysed according to initial randomisation arm. 
Modificirana populacija planirana za liječenje (mITT) uključivala je sve bolesnike koji su bili randomizirani, osim u slučaju povlačenja pristanka prije početka liječenja, te su bili analizirani prema skupini u koju su početno randomizirani.
3 mg/m2/dose (up to a maximum of one 5 mg vial) on Day 1 
3 mg/m2 po dozi (do maksimalno jedne bočice od 5 mg) 1. dana
Schedule modification for the treatment of hyperleukocytosis with cytarabine 
Tablica 2. Promjena rasporeda za liječenje hiperleukocitoze citarabinom Ciklus liječenja
• Bleeding (signs of a low number of blood cells known as platelets) Tell your doctor right away if you bruise easily or get nose bleeds on a regular basis, or have black tarry stools, coughing up of blood, bloody sputum, or change in your mental status. 
Odmah obavijestite svog liječnika ako lako dobivate modrice ili imate redovno krvarenje iz nosa, odnosno ako imate crne stolice poput katrana, iskašljavate krv, imate krvavi ispljuvak ili primijetite promjenu svog mentalnog stanja.
**Including fatal adverse reactions in the post-marketing setting. 
Uključujući smrtonosne nuspojave nakon stavljanja lijeka u promet.
***Frequency is based on laboratory values (Grade per NCI CTCAE v4.03). 
National Cancer Institute Common Terminology Criteria for Adverse Events, NCI CTCAE) verziji 4.03).
j. Tachycardia includes the following reported PTs: Tachycardia, Sinus tachycardia, Heart rate increased#, and 
Tahikardija uključuje sljedeće zabilježene preporučene pojmove: tahikardija, sinusna tahikardija, povećana frekvencija srca
The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 32 and 35 days, respectively. 
100 000/mm 3. Medijani vremena do povrata broja trombocita na 50 000/mm 3 i 100 000/mm iznosili su 32, odnosno 35 dana.
Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of CD33-directed monoclonal antibody (hP67.6) that is covalently linked to the cytotoxic agent N-acetyl-gamma calicheamicin. 
Gemtuzumab ozogamicin je konjugat antitijela i lijeka (ADC) sastavljen od monoklonskog antitijela usmjerenog na CD33 (hP67.6) koje je kovalentno vezano na citotoksičnu tvar N-acetil-gamakalikeamicin.
Effect on UGT substrates 
Učinak na supstrate UGT-a
The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in monotherapy studies were infection, haemorrhage, multi-organ failure, and VOD. 
Najčešće (≥ 1 %) nuspojave koje su dovele do trajnog prekida u ispitivanju monoterapije bile su infekcija, hemoragija, višeorgansko zatajenje i VOD.
Risk difference [95% CI]f p-valueg 
Razlika u riziku [95 % CI] p-vrijednost
r. Hyperbilirubinaemia includes the following reported PTs: Blood bilirubin increased and Hyperbilirubinaemia. 
Hiperbilirubinemija uključuje sljedeće zabilježene preporučene pojmove: povećane razine bilirubina u krvi i hiperbilirubinemija.
The secondary endpoints included CR and CRp rates, relapse-free survival (RFS), overall survival (OS), and safety of the combination DA with or without MYLOTARG. 
Sekundarne mjere ishoda uključivale su stope potpune remisije i potpune remisije s nepotpunim oporavkom trombocita, preživljenje bez recidiva, ukupno preživljenje i sigurnost kombinacije DA s lijekom MYLOTARG ili bez njega.
Effects on the reproductive tract of female monkeys were observed in the 12-week study (atrophy of the ovary, oviduct, uterus, and cervix; approximately 193 times the human clinical exposure after the third dose of 3 mg/m2). 
Učinci na reproduktivni sustav ženki majmuna zabilježeni su u ispitivanju koje je trajalo 12 tjedana (atrofija jajnika, jajovoda, maternice i vrata maternice pri izloženosti približno 193 puta većoj od kliničke izloženosti ljudi nakon treće doze od 3 mg/m
c. Venoocclusive liver disease includes the following reported PTs: Venoocclusive disease and Venoocclusive liver disease*. 
Venookluzivna bolest jetre uključuje sljedeće zabilježene preporučene pojmove: venookluzivna bolest i venookluzivna bolest jetre t.
Abbreviations: N=number of patients; PT=preferred term. 
Kratice: N=broj bolesnika; PT preporučeni pojam Uključujući smrtni ishod.
MYLOTARG 5 mg powder for concentrate for solution for infusion 
MYLOTARG 5 mg prašak za koncentrat za otopinu za infuziju
In a female rat fertility study slightly lower numbers of corpora lutea and increased embryolethality were observed in the presence of maternal toxicity (approximately 9.7 times, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168). 
U ispitivanju plodnosti ženki štakora zabilježeni su neznatno manji brojevi žutih tijela i povećana embrionalna smrtnost u prisutnosti toksičnosti za majku (izloženost približno 9,7 puta veća od kliničke izloženosti ljudi nakon treće doze od 3 mg/m na temelju vrijednosti AUC168).
Haemorrhage*b 
Frakcionirani b
Non-clinical data suggest that the anticancer activity of gemtuzumab ozogamicin is due to the binding of the ADC to CD33-expressing tumour cells, followed by internalisation of the ADC-CD33 complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker. 
Neklinički podaci ukazuju da gemtuzumab ozogamicin ima protutumorsku aktivnost zahvaljujući vezivanju ADC-a na tumorske stanice s ekspresijom CD33, nakon čega slijedi unošenje kompleksa
e: Where analysed, median recovery (defined as 20 x 109/L or 50 x 109/L for platelets and 0.5 x 109/L for neutrophils) ranged from 42-48 days for platelets and 30-37 days for neutrophils. 
9/l za trombocite i 0,5 x 10 9/l za neutrofile) kretao se u rasponu od 42 do 48 dana za trombocite i od 30 do 37 dana za neutrofile.
Effect on drug transporter substrates 
Učinak na supstrate prijenosnika lijeka
In the consolidation 1 phase of therapy, 94 (96.9%) patients had neutrophil recovery to counts of 500/mm3, and 91 (94%) patients recovered to counts of 1,000/mm3. 
Tijekom 1. faze konsolidacijske terapije u 94 (96,9 %) bolesnika broj neutrofila vratio se na 500/mm 3, a u 91
Gemtuzumab ozogamicin is a CD33-targeted ADC. 
Gemtuzumab ozogamicin je konjugat antitijela i lijeka usmjeren na CD33.
2-hour period under close clinical monitoring, including pulse, blood pressure, and temperature. 
Rekonstituiranu i razrijeđenu otopinu treba primijeniti intravenski putem infuzije u trajanju od 2 sata pod pomnim kliničkim nadzorom, uključujući praćenje pulsa, krvnog tlaka i temperature.
3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 1, 4, and 7 
3 mg/m2 po dozi (do maksimalno jedne bočice od 5 mg) 1., 4. i 7. dana
Median EFS was 17.3 months (95% CI: 13.4, 30.0) in the MYLOTARG arm versus 9.5 months (95% CI: 8.1, 12.0) in the DA alone arm; hazard ratio (HR) 0.562 (95% CI: 0.415, 0.762); 2-sided p=0.0002 by log-rank test. Efficacy data from ALFA-0701 study are summarised in Table 8, and the Kaplan-Meier plot for EFS is shown in Figure 1. 
Medijan preživljenja bez događaja bio je 17,3 mjeseca (95 % CI: 13,4; 30,0) u skupini koja je primala lijek MYLOTARG naspram 9,5 mjeseci (95 % CI: 8,1; 12,0) u skupini koja je primala samo DA; omjer hazarda (engl. hazard ratio, HR) 0,562 (95 % CI: 0,415; 0,762); za dvostrani long rank test p=0,0002.
Pfizer Ελλάς A.E. Τηλ: +30 210 6785 800 
Τηλ: +30 210 6785 800
During the consolidation 1 phase, 92 (94.8%) and 71 (73.2%) patients had a platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively. 
Tijekom 1. faze konsolidacije u 92 (94,8 %) i 71 (73,2 %) bolesnika zabilježen je povrat broja trombocita na 50 000/mm 3, odnosno
In the consolidation 2 phase of therapy, 80 (97.6%) patients had neutrophil recovery to counts of 500/mm3, and 79 (96.3%) patients recovered to counts of 1,000/mm3. 
Tijekom 2. faze konsolidacijske terapije u 80 (97,6 %) bolesnika broj neutrofila se vratio na 500/mm 3, a u 79 (96,3 %)
Event-free survival by investigator assessment by AML risk classifications from study ALFA-0701 (mITT Population) 
Ukupno preživljenje na temelju klasifikacija rizika kod AML-a iz ispitivanja ALFA--0701 (mITT populacija)
If not used immediately, store at room temperature (below 25°C) for up to 6 hours. 
Ako se ne primijeni odmah, može se čuvati do 6 sati na sobnoj temperaturi (ispod 25 °C).
N-acetyl gamma calicheamicin DMH (the released cytotoxin) was found to be mutagenic and clastogenic. 
Zaključeno je da je N-acetil-gama-kalikeamicindimetilhidrazid (oslobođeni citotoksin) mutagen i klastogen.
chills or fever, back pain during or after MYLOTARG infusion 
oticanje ili osjećaj vrućice ili zimice (to su znakovi reakcije povezane s infuzijom) tijekom ili ubrzo nakon infuzije lijeka MYLOTARG
60 mg/m2/day on Day 3 to Day 5 
60 mg/m2 na dan od 3. do 5. dana
o. Abdominal pain includes the following reported PTs: Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal discomfort, and Abdominal tenderness. 
Bol u abdomenu uključuje sljedeće zabilježene preporučene pojmove: bol u abdomenu, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena, nelagoda u abdomenu i osjetljivost abdomena.
e. Leukopenia includes the following reported PTs: Leukopenia and White blood cell count decreased. 
Leukopenija uključuje sljedeće zabilježene preporučene pojmove: leukopenija i smanjen broj leukocita.
MYLOTARG was given as induction treatment in most studies (82.4%). 
većini ispitivanja (82,4 %) lijek MYLOTARG se davao kao uvodno liječenje.
Relapse-free survival (by Investigator) 
Preživljenje bez recidiva (prema ispitivaču)
Each vial contains 5 mg of gemtuzumab ozogamicin. 
Jedna bočica sadrži 5 mg gemtuzumab ozogamicina.
**Only selected safety data were collected in this study of newly diagnosed AML. 
U ovom ispitivanju novodijagnosticiranog AML-a prikupljeni su samo odabrani sigurnosni podaci.
4 studies; N per study (range) 12-84; 42.2% 
Infekcija 5 ispitivanja; broj po ispitivanju (raspon) 12 - 30; 28,4 % 4 ispitivanja; broj po ispitivanju (raspon) 12 - 84; 42,2 % Mijelosu presija
Infusion should be interrupted immediately for patients who develop evidence of severe reactions, especially dyspnoea, bronchospasm, or clinically significant hypotension. 
U slučaju da bolesnici razviju znakove teških reakcija, osobito dispneje, bronhospazma ili klinički značajne hipotenzije, infuziju je potrebno odmah prekinuti.
Persistent thrombocytopenia (Platelets < 100,000/mm3 at the planned start date of the consolidation course) 
Perzistirajuća trombocitopenija (trombociti < 100 000/mm