FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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.
English: 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).
Croatian: 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
English: c. Venoocclusive liver disease includes the following reported PTs: Venoocclusive disease and Venoocclusive liver disease*.
Croatian: Venookluzivna bolest jetre uključuje sljedeće zabilježene preporučene pojmove: venookluzivna bolest i venookluzivna bolest jetre t.
English: Abbreviations: N=number of patients; PT=preferred term.
Croatian: Kratice: N=broj bolesnika; PT preporučeni pojam Uključujući smrtni ishod.
English: MYLOTARG 5 mg powder for concentrate for solution for infusion
Croatian: MYLOTARG 5 mg prašak za koncentrat za otopinu za infuziju
English: 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).
Croatian: 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).
English: Haemorrhage*b
Croatian: Frakcionirani b
English: 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.
Croatian: Neklinički podaci ukazuju da gemtuzumab ozogamicin ima protutumorsku aktivnost zahvaljujući vezivanju ADC-a na tumorske stanice s ekspresijom CD33, nakon čega slijedi unošenje kompleksa
English: 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.
Croatian: 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.
English: Effect on drug transporter substrates
Croatian: Učinak na supstrate prijenosnika lijeka
English: 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.
Croatian: Tijekom 1. faze konsolidacijske terapije u 94 (96,9 %) bolesnika broj neutrofila vratio se na 500/mm 3, a u 91
English: Gemtuzumab ozogamicin is a CD33-targeted ADC.
Croatian: Gemtuzumab ozogamicin je konjugat antitijela i lijeka usmjeren na CD33.
English: 2-hour period under close clinical monitoring, including pulse, blood pressure, and temperature.
Croatian: 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.
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 1, 4, and 7
Croatian: 3 mg/m2 po dozi (do maksimalno jedne bočice od 5 mg) 1., 4. i 7. dana
English: Infection*a
Croatian: *a
English: 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.
Croatian: 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.
English: Pfizer Ελλάς A.E. Τηλ: +30 210 6785 800
Croatian: Τηλ: +30 210 6785 800
English: 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.
Croatian: Tijekom 1. faze konsolidacije u 92 (94,8 %) i 71 (73,2 %) bolesnika zabilježen je povrat broja trombocita na 50 000/mm 3, odnosno
English: 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.
Croatian: Tijekom 2. faze konsolidacijske terapije u 80 (97,6 %) bolesnika broj neutrofila se vratio na 500/mm 3, a u 79 (96,3 %)
English: Event-free survival by investigator assessment by AML risk classifications from study ALFA-0701 (mITT Population)
Croatian: Ukupno preživljenje na temelju klasifikacija rizika kod AML-a iz ispitivanja ALFA--0701 (mITT populacija)
English: If not used immediately, store at room temperature (below 25°C) for up to 6 hours.
Croatian: Ako se ne primijeni odmah, može se čuvati do 6 sati na sobnoj temperaturi (ispod 25 °C).
English: N-acetyl gamma calicheamicin DMH (the released cytotoxin) was found to be mutagenic and clastogenic.
Croatian: Zaključeno je da je N-acetil-gama-kalikeamicindimetilhidrazid (oslobođeni citotoksin) mutagen i klastogen.
English: chills or fever, back pain during or after MYLOTARG infusion
Croatian: oticanje ili osjećaj vrućice ili zimice (to su znakovi reakcije povezane s infuzijom) tijekom ili ubrzo nakon infuzije lijeka MYLOTARG
English: 60 mg/m2/day on Day 3 to Day 5
Croatian: 60 mg/m2 na dan od 3. do 5. dana
English: o. Abdominal pain includes the following reported PTs: Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal discomfort, and Abdominal tenderness.
Croatian: 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.
English: e. Leukopenia includes the following reported PTs: Leukopenia and White blood cell count decreased.
Croatian: Leukopenija uključuje sljedeće zabilježene preporučene pojmove: leukopenija i smanjen broj leukocita.
English: MYLOTARG was given as induction treatment in most studies (82.4%).
Croatian: većini ispitivanja (82,4 %) lijek MYLOTARG se davao kao uvodno liječenje.
English: Relapse-free survival (by Investigator)
Croatian: Preživljenje bez recidiva (prema ispitivaču)
English: Each vial contains 5 mg of gemtuzumab ozogamicin.
Croatian: Jedna bočica sadrži 5 mg gemtuzumab ozogamicina.
English: **Only selected safety data were collected in this study of newly diagnosed AML.
Croatian: U ovom ispitivanju novodijagnosticiranog AML-a prikupljeni su samo odabrani sigurnosni podaci.
English: 4 studies; N per study (range) 12-84; 42.2%
Croatian: Infekcija 5 ispitivanja; broj po ispitivanju (raspon) 12 - 30; 28,4 % 4 ispitivanja; broj po ispitivanju (raspon) 12 - 84; 42,2 % Mijelosu presija
English: Infusion should be interrupted immediately for patients who develop evidence of severe reactions, especially dyspnoea, bronchospasm, or clinically significant hypotension.
Croatian: U slučaju da bolesnici razviju znakove teških reakcija, osobito dispneje, bronhospazma ili klinički značajne hipotenzije, infuziju je potrebno odmah prekinuti.
English: Persistent thrombocytopenia (Platelets < 100,000/mm3 at the planned start date of the consolidation course)
Croatian: Perzistirajuća trombocitopenija (trombociti < 100 000/mm
English: In 23.5% of the studies the majority of patients received fractionated (3 mg/m2 on Day 1, 4, 7) doses of MYLOTARG, while in 35.3% of the studies doses higher than 3 mg/m2 were given.
Croatian: 7. dan) doze lijeka MYLOTARG, dok su se u 35,3 % ispitivanja davale doze veće od 3 mg/m 2.
English: 200 mg/m2/day on Day 1 to Day 7
Croatian: 200 mg/m2 na dan od 1. do 7. dana
English: 1 g/m2/every 12 hours on Day 1 to Day 4
Croatian: 1 g/m2/svakih 12 sati, od 1. do 4. dana
English: Non-fractionatedb MYLO TARG
Croatian: Nefrakcionirani MYLOTARG
English: MYLOTARG contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: For patients who develop abnormal liver tests, more frequent monitoring of liver tests and clinical signs and symptoms of hepatotoxicity is recommended.
Croatian: Preporučuje se češće praćenje jetrenih testova i kliničkih znakova i simptoma hepatotoksičnosti u bolesnika u kojih se pokažu abnormalni nalazi jetrenih testova.
English: 1 g/m2/every 12 hours on Day 1 to Day 3
Croatian: 1 g/m2 svakih 12 sati, od 1. do 3. dana
English: i. Hyperglycaemia includes the following reported PTs: Hyperglycaemia and Blood glucose increased#.
Croatian: Hiperglikemija uključuje sljedeće zabilježene preporučene pojmove: hiperglikemija i povećana razina glukoze u krvi j.
English: Blood and lymphatic system disorders Very common
Croatian: Poremećaji krvi i limfnog sustava Vrlo često Febrilna neutropenija Trombocitopenija
English: Nervous system disorders Very common Headache Cardiac disorders Very common Tachycardiaj
Croatian: Srčani poremećaji Vrlo često Tahikardija Krvožilni poremećaji Vrlo često Hemoragija
English: fungal lung infections including Pulmonary mycosis and Pneumocystis jirovecii pneumonia*; and bacterial infections including Stenotrophomonas infection were also reported.
Croatian: * te bakterijske infekcije uključujući infekciju uzrokovanu bakterijom Stenotrophomonas.
English: Consider omitting scheduled dose if delayed more than 2 days between sequential infusions.
Croatian: Ako ste zakasnili više od 2 dana s primjenom neke od uzastopnih doza iz ciklusa, razmislite o propuštanju te doze.
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 34 and 35 days, respectively.
Croatian: 50 000/mm 3 i 100 000/mm iznosili su 34, odnosno 35 dana.
English: • If platelet count recovery remains < 50,000/mm3 for greater than 14 days consolidation therapy should be re-evaluated and a BMA should be performed to re-assess the patients' status.
Croatian: 3 dulje od 14 dana, potrebno je ponovno procijeniti terapiju konsolidacije i provesti aspiraciju koštane srži (engl. bone marrow aspiration, BMA) kako bi se ponovno procijenilo stanje bolesnika.
English: d. Anaemia includes the following reported PTs: Anaemia and Haemoglobin decreased.
Croatian: Anemija uključuje sljedeće zabilježene preporučene pojmove: anemija i snižene vrijednosti hemoglobina.
English: Mylotarg vials contain 5 mg of drug product with no overfill.
Croatian: Bočice lijeka Mylotarg sadrže 5 mg lijeka.
English: (5.3%), Bacterial infection (9.2%), Gastrointestinal infection (8.4%), Skin infection (2.3%), and Other infections b. Haemorrhage includes Central nervous system haemorrhage (3.1%), Upper gastrointestinal haemorrhage (33.6%), Lower gastrointestinal haemorrhage (17.6%), Subcutaneous haemorrhage (60.3%), Other haemorrhage (64.9%), and Epistaxis (62.6%).
Croatian: Hemoragija uključuje hemoragiju u središnjem živčanom sustavu (3,1 %), hemoragiju u gornjem dijelu gastrointestinalnog sustava (33,6 %), hemoragiju u donjem dijelu gastrointestinalnog sustava (17,6 %), supkutanu hemoragiju (60,3 %), drugu hemoragiju (64,9 %) i epistaksu (62,6 %).
English: There have been reports of fatal infusion reactions in the post-marketing setting.
Croatian: Postoje izvješća nakon stavljanja lijeka u promet o reakcijama povezanim s infuzijom, a koje su imale smrtni ishod.
English: ≤ 2.5 × ULN prior to each dose (see Table 4, sections 4.4 and 5.2).
Croatian: Odgodite primjenu lijeka MYLOTARG dok se ukupni bilirubin ne vrati na ≤ 2 × GGN, a AST i ALT na ≤ 2,5 × GGN prije svake doze (vidjeti tablicu 4, dijelove 4.4 i 5.2).
English: Ratec
Croatian: Razrjeđivanje
English: Number of studies
Croatian: 13. BROJ SERIJE
English: Effect of gemtuzumab ozogamicin on other medicinal products Effect on CYP substrates
Croatian: Učinak gemtuzumab ozogamicina na druge lijekove
English: • allergic reaction: experience a high-pitched whistling sound during breathing (wheezing), difficult breathing, shortness of breath or cough with or without mucous, hives, itching, swelling, or feeling fever and chills (signs of an infusion related reaction) during or shortly after the MYLOTARG infusion.
Croatian: • imate alergijsku reakciju: primijetite pojavu visokog, zvižduku sličnog zvuka tijekom disanja (piskanje), otežano disanje, nedostatak zraka ili kašalj sa ili bez sluzi, koprivnjaču, svrbež,
English: Neutrophils decreased Hyperglycaemia Aspartate aminotransferase (AST) increas ed Prothrombin time increased Activated partial thromboplastin time prolonged Alkaline phosphatase increased
Croatian: Povišene razine aspartat aminotransferaze (AST) Produljeno protrombinsko vrijeme
English: Hazard ratio [95% CI]c p-valued
Croatian: Omjer hazarda [95 % CI] p-vrijednost
English: Abbreviations: AML =acute myeloid leukaemia; CI=confidence interval; EFS=event-free survival; ELN=European LeukaemiaNet; mIT T =modified intent-to-treat; n=number; N=number; NE=not estimable.
Croatian: Kratica: AML=akutna mijeloična leukemija; CI=raspon pouzdanosti; EFS=preživljenje bez događaja; ELN=Europska mreža za leukemiju (engl.
English: In patients with hyperleukocytic AML, leukoreduction should be considered with hydroxyurea or leukapheresis to reduce the peripheral WBC count to below 30,000/mm3 prior to administration of MYLOTARG to reduce the risk of inducing TLS (see section 4.2).
Croatian: U bolesnika s AML-om s hiperleukocitozom potrebno je razmotriti mogućnost leukoredukcije hidroksiurejom ili leukaferezom, kako bi se smanjenjem broja leukocita u perifernoj krvi na manje od 30 000/mm
English: u. Rash includes the following reported PTs: Rash, Dermatitis#, Dermatitis allergic#, Dermatitis bullous, Dermatitis contact, Dermatitis exfoliative#, Drug eruption, Pruritus allergic# and Rash erythematous#, Rash macular#, Rash maculo papular, Rash papular, Rash pruritic, Rash vesicular#.
Croatian: Osip uključuje sljedeće zabilježene preporučene pojmove: osip, dermatitis #, alergijski dermatitis #, bulozni dermatitis,
English: Respiratory, thoracic and mediastinal disorders Very common Dyspnoean
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često Dispneja
English: Adverse reactions in patients who received MYLOTARG in monotherapy*** studies and post-marketing
Croatian: Tablica 6. Nuspojave u bolesnika koji su primali lijek MYLOTARG u ispitivanjima monoterapije i nakon stavljanja lijeka u promet
English: Use in AML with adverse-risk cytogenetics
Croatian: Primjena u slučaju AML-a s nepovoljnom citogenetikom
English: Bronchospasm, Drug hypersensitivity, and Injection site urticaria#.
Croatian: kontaktni dermatitis, eksfolijativni dermatitis #, medikamentni osip, alergijski pruritus # i eritematozni osip
English: h. Infusion related reaction includes the following reported PTs: Infusion related reaction, Urticaria, Hypersensitivity,
Croatian: Reakcija povezana s infuzijom uključuje sljedeće zabilježene preporučene pojmove: reakcija povezana s infuzijom, urtikarija, preosjetljivost, bronhospazam, preosjetljivost na lijekove i urtikarija na mjestu primjene injekcije i.
English: During the induction phase, 109 (83.2%) and 99 (75.6%) patients had platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Croatian: Tijekom faze uvodnog liječenja u 109 (83,2 %) i 99 (75,6 %) bolesnika zabilježen je povrat broja trombocita na 50 000/mm 3, odnosno 100 000/mm 3. Medijani vremena do povrata broja trombocita na
English: • Fatigue
Croatian: • mučnina
English: y. Fatigue includes the following reported PTs: Fatigue, Asthenia, Lethargy, and Malaise.
Croatian: Umor uključuje sljedeće zabilježene preporučene pojmove: umor, astenija, letargija i malaksalost.
English: • Prolonged clotting time
Croatian: • produljeno vrijeme zgrušavanja krvi
English: • Each vial contains 5 mg gemtuzumab ozogamicin.
Croatian: • Jedna bočica sadrži 5 mg gemtuzumab ozogamicina.
English: Lower gastrointestinal haemorrhage (15.2%), Subcutaneous haemorrhage (28.5%), Other haemorrhage (32.9%), and
Croatian: Hemoragije uključuju hemoragiju središnjeg živčanog sustava (5,1 %), gornju gastrointestinalnu hemoragiju (21,3 %), donju gastrointestinalnu hemoragiju (15,2 %), supkutanu hemoragiju (28,5 %), drugu hemoragiju (32,9 %) i epistaksu l.
English: • Liver failure
Croatian: • nedostatak zraka
English: Dose modifications for non-haematological toxicities Non-haematological toxicities Dose modifications VOD/SOS
Croatian: Tablica 4. Promjene doze za nehematološke toksičnosti Nehematološke toksičnosti
English: 60 mg/m2/day on Day 1 to Day 2
Croatian: 60 mg/m2 na dan, od 1. do 2. dana
English: Treatment course
Croatian: Način primjene
English: • Mouth inflammation
Croatian: • upala usne šupljine
English: No formal PK studies of gemtuzumab ozogamicin have been conducted in patients with hepatic impairment.
Croatian: Nisu provedena službena farmakokinetička ispitivanja gemtuzumab ozogamicina u bolesnika s oštećenjem funkcije jetre.
English: Number of events, n (%) Median RFS in months [95% CI]a
Croatian: Broj događaja, n (%) Medijan preživljenja bez događaja u mjesecima [95 % CI]
English: After reconstitution each vial contains 1 mg/mL gemtuzumab ozogamicin.
Croatian: Nakon rekonstitucije jedna bočica sadrži 1 mg/ml gemtuzumab ozogamicina.
English: Immunogenicity
Croatian: Hiperuricemija
English: Cytogenetics (unfavourable), N Number of events, n (%) Median EFS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Croatian: Citogenetika (nepovoljna), N Broj događaja, n (%) Medijan preživljenja bez događaja u mjesecima [95 % CI] Omjer hazarda [95 % CI]
English: Investigations Very common Blood lactate dehydrogenase increased Common Blood alkaline phosphate increased
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često Pireksija Edem Umor Zimica Često Višeorgansko zatajenje Pretrage Vrlo često Povišene razine laktat dehidrogenaze u krvi Često Povišene razine alkalne fosfataze u krvi
English: During the induction phase, 121 (92.4%) and 118 (90.1%) patients had a documented neutrophil recovery to ANC of 500/mm3 and 1,000/mm3, respectively.
Croatian: Tijekom faze uvodnog liječenja u 121 (92,4 %) i 118 (90,1 %) bolesnika zabilježen je povrat broja neutrofila na apsolutni broj neutrofila od 500/mm 3, odnosno 1000/mm 3. Medijan vremena do povrata broja neutrofila na apsolutni broj neutrofila od 500/mm 3 i 1000/mm 3 iznosio je 25 dana.
English: VO D VO D post HSCT
Croatian: HSCT a
English: b. Thrombocytopenia includes the following reported PTs: Platelet count decreased and Thrombocytopenia*.
Croatian: Trombocitopenija uključuje sljedeće zabilježene preporučene pojmove: smanjen broj trombocita i trombocitopenija c.
English: See also section 6.3 for dilution, storage, and infusion information.
Croatian: Informacije o razrjeđivanju, čuvanju i infuziji vidjeti također u dijelu 6.3.
English: Hepatobiliary disorders Very common Transaminases increasedq Hyperbilirubinaemiar
Croatian: Povišene razine transaminaza Hiperbilirubinemija
English: The median times to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 were 22 and 27 days, respectively.
Croatian: bolesnika vratio se na 1000/mm 3. Medijani vremena do povrata broja neutrofila na apsolutni broj neutrofila od 500/mm 3 i 1000/mm 3 iznosili su 22, odnosno 27 dana.
English: g. Lymphopenia includes the following reported PTs: Lymphopenia and Lymphocyte count decreased.
Croatian: Limfopenija uključuje sljedeće zabilježene preporučene pojmove: limfopenija i smanjen broj limfocita.
English: 35 mg/m2/day on Day 1 to Day 2
Croatian: 35 mg/m 2 na dan, od 1. do
English: • Shortness of breath
Croatian: • brzi otkucaji srca
English: ELN (favourable/intermediate), N Number of events, n (%) Median EFS in months [95% CI]a
Croatian: ELN (povoljno/intermedijarni rizik), N Broj događaja, n (%) Medijan preživljenja bez događaja u mjesecima [95 % CI]
English: • Indigestion
Croatian: • umor
English: Τηλ: +357 22 817690
Croatian: Pfizer Ελλάς Α.Ε. (Cyprus Branch) Τηλ: +357 22 817690
English: An in-line, low protein-binding 0.2 micron polyethersulphone (PES) filter must be used for infusion of MYLOTARG.
Croatian: Za infuziju lijeka MYLOTARG potreban je ugrađeni filtar od polietersulfona (PES) s porama od 0,2 mikrometra i s niskim vezanjem proteina.
English: ELN (poor/adverse), N Number of events, n (%) Median EFS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Croatian: ELN (slabo/loše), N Broj događaja, n (%) Medijan preživljenja bez događaja u mjesecima [95 % CI] Omjer hazarda [95 % CI]
English: ELN (favourable/intermediate), N Number of deaths, n (%) Median OS in months [95% CI]a
Croatian: ELN (povoljno/intermedijarni rizik), N Broj smrtnih slučajeva, n (%) Medijan ukupnog preživljenja u mjesecima [95 % CI]
English: No formal PK studies of gemtuzumab ozogamicin have been conducted in patients with renal impairment.
Croatian: Nisu provedena službena farmakokinetička ispitivanja gemtuzumab ozogamicina u bolesnika s oštećenjem funkcije bubrega.
English: Abbreviat ion: P T =preferred t erm.
Croatian: Kratica: PT=preporučeni pojam.
English: The median times to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 were 21 and 25 days, respectively.
Croatian: (94 %) bolesnika vratio se na 1000/mm 3. Medijani vremena do povrata broja neutrofila na apsolutni broj neutrofila od 500/mm 3 i 1000/mm 3 iznosili su 21, odnosno 25 dana.
English: • Chills
Croatian: • proljev
English: During the consolidation 2 phase, 80 (97.6%) and 70 (85.4%) patients had a platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Croatian: Tijekom 2. faze konsolidacije u 80 (97,6 %) i 70 (85,4 %) bolesnika zabilježen je povrat broja trombocita na 50 000/mm 3, odnosno 100 000/mm 3. Medijani vremena do povrata broja trombocita na 50 000/mm 3 i 100 000/mm iznosili su 36,5, odnosno 43 dana.
English: Dilution
Croatian: Dispepsija
English: SN
Croatian: *s
English: Vascular disorders Very common
Croatian: Krvožilni poremećaji Vrlo često
English: ≤ 2.5 × ULN.
Croatian: 9 mg/m 2.
English: • Pain in the abdomen
Croatian: • bol u trbuhu
English: Cytogenetics (favourable/intermediate), N Number of deaths, n (%) Median OS in months [95% CI]a
Croatian: Citogenetika (nepovoljna), N Broj smrtnih slučajeva, n (%) Medijan ukupnog preživljenja u mjesecima [95 % CI]
English: Abbreviations: AML=acute myeloid leukaemia; CI=confidence interval; ELN=European LeukaemiaNet; mITT=modified intent-to-treat; n=number; N=number; NE=not estimable; OS=Overall Survival a. Median estimated by Kaplan-Meier method; CI based on the Brookmeyer and Crowley Method with log-log transformation.
Croatian: European Leukaemia Net); mITT= modificirana populacija planirana za liječenje; n=broj; N=broj; NP=nije procjenjivo; OS=ukupno preživljenje a.
English: • Gently swirl the vial to aid dissolution.
Croatian: • Lagano vrtite bočicu kako biste pospješili otapanje.
English: a. Infection includes Sepsis and Bacteraemia (53.4%), Fungal infection (15.3%), Lower respiratory tract infection
Croatian: Infekcija uključuje sepsu i bakterijemiju (53,4 %), gljivičnu infekciju (15,3 %), infekciju donjih dišnih puteva (5,3 %), bakterijsku infekciju (9,2 %), gastrointestinalnu infekciju (8,4 %), kožnu infekciju (2,3 %) i druge infekcije (28,4 %).
English: How to store MYLOTARG 6.
Croatian: Kako čuvati MYLOTARG 6. Sadržaj pakiranja i druge informacije
English: Тел.
Croatian: x.
English: Rate
Croatian: Primjena
English: ANNEX II
Croatian: Nefrakcionirani b