FrancophonIA/ELRC3.0 huggingface dataset:
English: In the combination setting, the response rate was 49.0% with non-fractionated MYLOTARG (3 studies) and 38.8% with fractionated MYLOTARG (2 studies).
Croatian: Kod primjene u kombinaciji stopa odgovora je iznosila 49,0 % s nefrakcioniranim lijekom MYLOTARG (3 ispitivanja) i 38,8 % s frakcioniranim lijekom MYLOTARG (2 ispitivanja).
English: In the combination therapy study, safety data consisting of selected treatment emergent adverse events (TEAEs) considered most important for understanding the safety profile of MYLOTARG consisted of all grades haemorrhages, all grades VOD, and severe infections.
Croatian: U ispitivanju kombiniranog liječenja sigurnosni podaci, sastavljeni od odabranih štetnih događaja nastalih tijekom liječenja (engl. treatment emergent adverse events, TEAEs) koji se smatraju najvažnijim za razumijevanje sigurnosnog profila lijeka MYLOTARG, uključivali su hemoragije svih stupnjeva, VOD-ove svih stupnjeva i teške infekcije.
English: Tell your doctor right away if you have rapid weight gain, feel pain in the upper right side of your abdomen, have accumulation of fluid causing abdominal swelling.
Croatian: Odmah obavijestite svog liječnika ako brzo dobivate na težini, osjećate bol na desnoj strani gornjeg dijela trbuha te primijetite nakupljanje tekućine koja uzrokuje oticanje trbuha.
English: • It is recommended that the infusion container be made of polyvinyl chloride (PVC) with DEHP, or polyolefin (polypropylene and/or polyethylene).
Croatian: • Preporučuje se da spremnik za infuziju bude napravljen od polivinilklorida (PVC) s DEHP-om ili poliolefina (polipropilena i/ili polietilena).
English: Repeat-dose toxicity
Croatian: Toksičnost ponovljene doze
English: In the combination therapy study (N=131), VOD was reported in 6 (4.6%) patients during or following treatment, 2 (1.5%) of these reactions were fatal (see Table 5).
Croatian: Tijekom ispitivanja kombiniranog liječenja (N=131) VOD je bio zabilježen u 6 (4,6 %) bolesnika tijekom ili nakon liječenja, dok su 2 (1,5 %) od tih reakcija bile sa smrtnim ishodom (vidjeti tablicu 5).
English: However, it was also found that increased toxicity (post-remission toxic mortality) was observed in patients with low-risk AML which was attributed to the prolonged neutropenia that occurred after receiving gemtuzumab ozogamicin during intensification Course 2 (see sections 4.2 and 4.8).
Croatian: Međutim, isto je tako zaključeno da je povećana toksičnost (smrtnost nakon remisije uzrokovana toksičnošću) zabilježena u bolesnika s niskorizičnim AML-om što se pripisalo produljenoj neutropeniji koja se pojavila nakon primanja gemtuzumab ozogamicina tijekom intenzifikacijskog ciklusa 2 (vidjeti dijelove 4.2 i 4.8).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1277/001
Croatian: EU/1/18/1277/001
English: • Filtration of the diluted solution is required.
Croatian: • Potrebno je filtrirati razrijeđenu otopinu.
English: The terminal plasma half-life (t½) for hP67.6 was predicted to be approximately 160 hours for a typical patient at the recommended dose level (3 mg/m2) of MYLOTARG.
Croatian: Predviđa se da je terminalni poluvijek izlučivanja iz plazme (t½) za hP67.6 približno 160 sati za uobičajenog bolesnika pri preporučenoj dozi(3 mg/m2) lijeka MYLOTARG.
English: MYLOTARG is light sensitive and should be protected from ultraviolet light during reconstitution, dilution and administration.
Croatian: MYLOTARG je osjetljiv na svjetlo te ga treba zaštititi od ultraljubičastih zraka tijekom rekonstitucije, razrjeđivanja i primjene.
English: Patients with acute promyelocytic leukaemia (APL, AML3) and patients with AML arising from myelodysplastic syndrome (MDS) or secondary AML were excluded from the study.
Croatian: Bolesnici s akutnom promijelocitnom leukemijom (APL, AML3) i bolesnici sa AML-om nastalim iz mijelodisplastičnog sindroma (MDS) ili sekundarnim AML-om bili su isključeni iz ispitivanja.
English: Due to the risk of VOD/SOS, signs and symptoms of VOD/SOS should be closely monitored; these may include elevations in ALT, AST, total bilirubin, and alkaline phosphatase, which should be monitored prior to each dose of MYLOTARG, hepatomegaly (which may be painful), rapid weight gain, and ascites.
Croatian: Zbog rizika od VOD/SOS-a potrebno je pažljivo pratiti znakove i simptome VOD/SOS-a; oni mogu uključivati povišene vrijednosti ALT-a, AST-a, ukupnog bilirubina i alkalne fosfataze, koje je potrebno pratiti prije svake doze lijeka MYLOTARG, hepatomegaliju (koja može biti bolna), brzo dobivanje na težini i ascites.
English: Safety results from a systematic literature review in paediatric patients with relapsed or refractory AML who received MYLOTARG
Croatian: Rezultati sigurnosti primjene iz sistematskog pregleda literature u pedijatrijskih bolesnika s recidivnim ili refraktornim AML-om koji su primali lijek MYLOTARG
English: What MYLOTARG contains
Croatian: Što MYLOTARG sadrži
English: • Oedema (excess fluid in body tissue, causing swelling of the hands and feet)
Croatian: • edem (nakupljeni višak tekućine u tjelesnom tkivu koji uzrokuje oticanje šaka i stopala)
English: Safety results observed in a systematic literature review of studies evaluating MYLOTARG in paediatric patients (see section 5.1), are presented in Table 7.
Croatian: Rezultati sigurnosti primjene zabilježeni u sistematskom pregledu literature ispitivanja koja su procjenjivala lijek MYLOTARG u pedijatrijskih bolesnika (vidjeti dio 5.1) prikazani su u tablici 7.
English: In clinical studies, TLS was reported (see section 4.8).
Croatian: TLS je prijavljen u kliničkim ispitivanjima (vidjeti dio 4.8).
English: This is consistent with the known induction of DNA breaks by calicheamicin and other enediyne antitumour antibiotics.
Croatian: Ovo je u skladu s poznatom indukcijom lomova DNK nastalih zbog kalikeamicina i drugih endinskih antitumorskih antibiotika.
English: Do not mix MYLOTARG with, or administer as an infusion with, other medicinal products.
Croatian: MYLOTARG se ne smije miješati ili primjenjivati kao infuzija s drugim lijekovima.
English: A monoclonal antibody is a protein which recognises certain cancer cells.
Croatian: Monoklonsko antitijelo bjelančevina je koja prepoznaje određene stanice raka.
English: • Reduced number of white blood cells which may result in general weakness and a tendency to develop infections
Croatian: • smanjen broj bijelih krvnih stanica, što može rezultirati općom slabošću i sklonošću dobivanju infekcija
English: VOD was also reported in 2 patients who received MYLOTARG as a follow-up therapy following relapse of AML after chemotherapy treatment in the control arm of the combination therapy study.
Croatian: VOD je isto tako bio zabilježen u 2 bolesnika koji su primali lijek MYLOTARG u sklopu terapije u razdoblju praćenja nakon recidiva AML-a poslije liječenja kemoterapijom u kontrolnoj skupini ispitivanja kombiniranog liječenja.
English: During treatment, patients should be monitored for signs and symptoms of infection, bleeding/haemorrhage, or other effects of myelosuppression.
Croatian: Tijekom liječenja potrebno je obratiti pažnju na znakove i simptome infekcije, krvarenja/hemoragije ili druge učinke mijelosupresije u bolesnika.
English: Infusion related reactions (including anaphylaxis)
Croatian: Reakcije povezane s infuzijom (uključujući anafilaktičku reakciju)
English: 22.5 [15.5, NE]
Croatian: 22,5 [15,5; NP]
English: Given that the hP67.6 portion renders target selectivity on the intact molecule, and that gemtuzumab ozogamicin dosages are reported in terms of milligrams of protein (hP67.6), the hP67.6 concentration results are reported as the primary PK measures.
Croatian: S obzirom na to da hP67.6 dio ostvaruje selektivnost za cilj na intaktnoj molekuli i da se doze gemtuzumab ozogamicina izražavaju u miligramima proteina (hP67.6), rezultati koncentracije hP67.6 smatraju se primarnim farmakokinetičkim mjerama.
English: Dosing regimens for MYLOTARG in combination with chemotherapy
Croatian: Režimi doziranja za MYLOTARG u kombinaciji s kemoterapijom Ciklus liječenja
English: • Your doctor will do blood tests during the treatment to check for side effects and for response to treatment.
Croatian: • Liječnik će Vas slati na krvne pretrage tijekom liječenja kako bi provjeravao postoje li nuspojave te postoji li odgovor na liječenje.
English: • infection: have or think you have, an infection, develop chills or shivering, or feel warm, or have fever.
Croatian: • imate infekciju: imate ili mislite da imate infekciju, javi Vam se zimica ili drhtanje, odnosno ako ste vrući ili imate vrućicu.
English: • Following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, MYLOTARG solution should be infused immediately.
Croatian: • Nakon razrjeđivanja 0,9 %-tne (9 mg/ml) otopine natrijevog klorida za injekciju, otopinu lijeka MYLOTARG treba odmah infundirati.
English: Almost all patients (>90 %) experienced myelosuppression across studies a: When MYLOTARG was given in combination, cytarabine was part of the combination studied in 8 out of the 9 studies.
Croatian: U svim ispitivanjima je u gotovo svih bolesnika (> 90 %) nastupila mijelosupresija a: Kada se lijek MYLOTARG davao u kombinaciji, citarabin je bio dio kombinacije koja se ispitivala u 8 od 9 ispitivanja.
English: Patients should be monitored until signs and symptoms completely resolve and infusion may resume.
Croatian: Bolesnike je potrebno nadzirati dok se znakovi i simptomi u potpunosti ne povuku i dok se ne može nastaviti s infuzijom.
English: Tables 3 and 4 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
Croatian: Tablice 3 i 4 prikazuju smjernice za promjenu doze za hematološke, odnosno nehematološke toksičnosti.
English: • Inflammation of the bowel in association with low white blood cell counts
Croatian: • upala crijeva povezana s niskim brojem bijelih krvnih stanica
English: No cases of overdose with MYLOTARG were reported in clinical experience.
Croatian: Nisu prijavljeni slučajevi predoziranja s lijekom MYLOTARG iz kliničkog iskustva.
English: Discard any unused reconstituted solution left in the vial.
Croatian: Bacite neiskorištenu rekonstituiranu otopinu koja je preostala u bočici.
English: When MYLOTARG was given in combination, a cytarabine based regimen was used in 8 of the 9 studies.
Croatian: Kada se lijek MYLOTARG davao u kombinaciji, režim temeljen na citarabinu primjenjivao se u 8 od 9 ispitivanja.
English: • MYLOTARG contains no bacteriostatic preservatives.
Croatian: • MYLOTARG ne sadrži bakteriostatske konzervanse.
English: • The active substance is gemtuzumab ozogamicin.
Croatian: • Djelatna tvar je gemtuzumab ozogamicin.
English: • Before you receive MYLOTARG, you will be given some medicines to help reduce symptoms such as fever and chills, known as infusion reactions, during or shortly after the MYLOTARG infusion.
Croatian: • Prije nego što primite lijek MYLOTARG primit ćete lijekove koji pomažu ublažiti simptome kao što su vrućica i zimica, poznate kao reakcije povezane s infuzijom, koji se mogu javiti tijekom ili ubrzo nakon infuzije lijeka MYLOTARG.
English: Fatal severe infection was reported in 2 (1.53%) patients in the MYLOTARG arm and 4 (2.92%) patients in the control arm.
Croatian: Smrtonosna teška infekcija zabilježena je u 2 (1,53 %) bolesnika u skupini koja je primala MYLOTARG i u 4 (2,92 %) bolesnika u kontrolnoj skupini.
English: Patients should be monitored for signs and symptoms of TLS and treated according to standard medical practice.
Croatian: Potrebno je obratiti pažnju na znakove i simptome TLS-a u bolesnika te ih liječiti u skladu sa standardnom medicinskom praksom.
English: Store in a refrigerator (2°C-8°C).
Croatian: Čuvati u hladnjaku (2 C - 8 °C).
English: Formal carcinogenicity studies have not been conducted with gemtuzumab ozogamicin.
Croatian: Nisu provedena formalna ispitivanja kancerogenosti s gemtuzumab ozogamicinom.
English: Although the total dose of the fractionated dosing regimen is half of that of the original dosing regimen (9 versus 18 mg/m2), the predicted total AUC of hP67.6 over the course of treatment is 25%, and Cmax is 24%, of the values for original 9 mg/m2 dosing regimen, since the PK is nonlinear.
Croatian: Iako je ukupna doza režima podijeljenog doziranja pola one originalnog režima doziranja (9 naspram 18 mg/m2), predviđeni ukupni AUC za hP67.6 u ciklusu liječenja iznosi 25 %, a Cmax 24 % vrijednosti za originalni režim doziranja od 9 mg/m2, budući da je farmakokinetika nelinearna.
English: Do not use this medicine if you notice any particulate matter or discolouration prior to administration.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakve vidljive čestice ili promjenu boje prije primjene.
English: Eligible patients were between 50 and 70 years of age with previously untreated de novo AML (Study ALFA-0701).
Croatian: Bolesnici podobni za uključivanje u ispitivanje bili su u dobi između 50 i 70 godina i imali prethodno neliječen de novo AML (ispitivanje ALFA-0701).
English: All of these TEAEs were determined to be adverse drug reactions.
Croatian: Utvrđeno je da su svi ovi TEAEs nuspojave lijeka.
English: q. Transaminases increased includes the following reported PTs: Transaminases increased, Hepatocellular injury, Alanine aminotransferase increased, Aspartate aminotransferase increased, and Hepatic enzyme increased.
Croatian: Povećane razine transaminaza uključuju sljedeće zabilježene preporučene pojmove: povećane razine transaminaza, hepatocelularno oštećenje, povećane razine alanin aminotransferaze, povećane razine aspartat aminotransferaze i povećane razine jetrenih enzima.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici na bočici i kutiji iza oznake „EXP“.
English: No adjustment of the starting dose is required in patients with hepatic impairment defined by total bilirubin ≤ 2 × upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT)
Croatian: Nije potrebno prilagođavati početnu dozu u bolesnika s oštećenjem jetre koje je definirano ukupnim bilirubinom od ≤ 2 × gornja granica normalne vrijednosti (GGN) i aspartat aminotransferazom (AST)/alanin aminotransferazom (ALT) ≤ 2,5 × GGN.
English: Effect of other medicinal products on gemtuzumab ozogamicin
Croatian: Učinak drugih lijekova na gemtuzumab ozogamicin
English: How MYLOTARG will be given
Croatian: Kako će se MYLOTARG davati
English: The efficacy and safety of MYLOTARG were evaluated in a multicentre, randomised, open-label Phase 3 study comparing the addition of MYLOTARG to a standard chemotherapy induction regimen of daunorubicin and cytarabine (DA) versus DA alone.
Croatian: Djelotvornost i sigurnost lijeka MYLOTARG procijenjene su u multicentričnom, randomiziranom, otvorenom ispitivanju faze 3 koje je uspoređivalo dodavanje lijeka MYLOTARG standardnom kemoterapijskom indukcijskom režimu daunorubicina i citarabina (DA) naspram samog DA.
English: Toxic waste disposal procedures prescribed for anticancer medicinal products must be used.
Croatian: Potrebno je provesti postupke za zbrinjavanje toksičnog otpada propisane za lijekove protiv raka.
English: • Doses must be mixed to a concentration between 0.075 mg/mL to 0.234 mg/mL according to the following instructions: o Doses less than 3.9 mg must be prepared for administration by syringe.
Croatian: • Doze se mora pomiješati do koncentracije između 0,075 mg/ml i 0,234 mg/ml prema sljedećim uputama: o Doze manje od 3,9 mg moraju biti pripremljene za primjenu štrcaljkom.
English: Consider permanent discontinuation of treatment for severe or life-threatening infusion reactions (see section 4.4).
Croatian: Razmotrite trajan prekid liječenja u slučaju teških ili životno opasnih reakcija na infuziju (vidjeti dio 4.4).
English: In patients, unconjugated calicheamicin plasma levels were typically low, with a predicted mean Cmax of 1.5 ng/mL following the third dose.
Croatian: U bolesnika su razine nekonjugiranog kalikeamicina u plazmi obično niske, s predviđenom srednjom vrijednošću Cmax od 1,5 ng/ml nakon treće doze.
English: A second course of induction therapy with DA but without MYLOTARG, regardless of the randomisation arm, was allowed.
Croatian: Dopušten je drugi ciklus uvodnog liječenja s DA, ali bez lijeka MYLOTARG, bez obzira na randomizacijsku skupinu.
English: MYLOTARG is used to treat a certain type of cancer called acute myeloid leukaemia (AML) in which the bone marrow makes abnormal white blood cells.
Croatian: Lijek MYLOTARG se koristi za liječenje određene vrste raka koji se zove akutna mijeloična leukemija (AML) kod koje koštana srž stvara abnormalne bijele krvne stanice.
English: For IV infusion after reconstitution and dilution
Croatian: Za intravensku infuziju nakon rekonstitucije i razrjeđivanja
English: Based on Population PK analyses, the predicted clearance (CL) value of hP67.6 from plasma was 3 L/h immediately after the first dose and then 0.3 L/h.
Croatian: Na osnovi populacijskih farmakokinetičkih analiza predviđena vrijednost klirensa hP67.6 iz plazme iznosila je 3 l/h odmah nakon prve doze i tada 0,3 l/h.
English: Hepatotoxicity, including hepatic venoocclusive disease/sinusoidal obstruction syndrome (VOD/SOS)
Croatian: Hepatotoksičnost, uključujući venookluzivnu bolest jetre/sindrom sinusoidalne opstrukcije (VOD/SOS)
English: EFS and OS analysed by cytogenetic risk classification and cytogenetic/molecular risk classification are presented in Table 9 and Table 10 below.
Croatian: Preživljenje bez događaja i ukupno preživljenje, analizirano prema citogenetskoj klasifikaciji rizika i citogenetskoj/molekularnoj klasifikaciji rizika, prikazani su ispod u tablici 9 i tablici 10.
English: If AraC is used for leukoreduction with or without hydroxyurea in patients with previously untreated, de novo hyperleukocytic AML receiving MYLOTARG in combination therapy, apply the following modified schedule (Table 2):
Croatian: Ako se za leukoredukciju koristi AraC s hidroksiurejom ili bez nje u bolesnika s prethodno neliječenim, de novo AML-om s hiperleukocitozom, koji primaju lijek MYLOTARG u sklopu kombiniranog liječenja, primijenite sljedeći izmijenjeni raspored (tablica 2):
English: • Budd-Chiari syndrome, which includes pain in the upper right part of the belly, an abnormally large liver, and/or accumulation of fluid in the belly associated with blood clots in the liver.
Croatian: • Budd Chirai sindrom koji uključuje bol u gornjem desnom dijelu trbuha, abnormalno povećanje jetre i/ili nakupljanje tekućine u trbuhu povezane sa krvnim ugrušcima u jetri.
English: Age, race, and gender
Croatian: Dob, rasa i spol
English: MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see sections 4.4 and 5.1).
Croatian: MYLOTARG je indiciran za kombiniranu terapiju daunorubicinom (DNR) i citarabinom (AraC) za liječenje bolesnika od 15 godina i starijih s prethodno neliječenom, de novo CD-33 -pozitivnom akutnom mijeloičnom leukemijom (engl. acute myeloid leukaemia, AML), osim akutne promijelocitne leukemije (engl. acute promyelocytic leukaemia, APL (vidjeti dijelove 4.4 i 5.1)).
English: Additional characterisation of hepatotoxicity adverse reactions is provided from the monotherapy studies.
Croatian: Dodatna karakterizacija nuspojava hepatotoksičnosti dobivena je u ispitivanjima monoterapije.
English: b: Fractionated dosing refers to MYLOTARG dose of 3 mg/m2 on days 1, 4, 7.
Croatian: b: Frakcionirano doziranje odnosi se na dozu lijeka MYLOTARG od 3 mg/m2 1., 4. i 7. dan.
English: The overall safety profile of MYLOTARG is based on data from patients with acute myeloid leukaemia from the combination therapy study ALFA-0701, monotherapy studies, and from post-marketing experience.
Croatian: Ukupan sigurnosni profil lijeka MYLOTARG temelji se na podacima bolesnika s akutnom mijeloičnom leukemijom dobivenim u ispitivanju kombiniranog liječenja ALFA-0701, ispitivanjima monoterapije i iz razdoblja nakon stavljanja lijeka u promet.
English: Because of the potential for adverse reactions in breast-fed children, women should not breast-feed during treatment with MYLOTARG and for at least 1 month after the final dose (see section 5.3).
Croatian: Zbog mogućih nuspojava u dojenčadi, žene ne smiju dojiti za vrijeme terapije lijekom MYLOTARG i najmanje 1 mjesec nakon zadnje doze (vidjeti dio 5.3).
English: Tumour lysis syndrome (TLS)
Croatian: Sindrom lize tumora (engl. tumour lysis syndrome, TLS)
English: ***MYLOTARG in the treatment of relapsed AML (9 mg/m2).
Croatian: MYLOTARG u liječenju recidivnog AML-a (9 mg/m
English: The analysis included 405 patients in the following NCI ODWG impairment status categories: mild (B1, n=58 and B2, n=19), moderate (C, n=6), and normal hepatic function (n=322) (see section 4.2).
Croatian: U analizu je bilo uključeno 405 bolesnika razvrstano u sljedeće kategorije stanja oštećenja NCI ODWG-a: blaga (B1, n=58 i B2, n=19), umjerena (C, n=6) i normalna funkcija jetre (n=322) (vidjeti dio 4.2).
English: MYLOTARG is not for use in patients with a type of cancer called acute promyelocytic leukaemia (APL).
Croatian: MYLOTARG nije namijenjen za primjenu u bolesnika s vrstom raka koji se zove akutna promijelocitna leukemija (APL).
English: The safety and efficacy of MYLOTARG in paediatric patients with relapsed or refractory AML has not been established (see sections 4.1 and 4.2).
Croatian: Sigurnost i djelotvornost lijeka MYLOTARG u pedijatrijskih bolesnika s recidivnim ili refraktornim AML-om nisu ustanovljene (vidjeti dijelove 4.1 i 4.2).
English: • High blood sugar
Croatian: • povišene razine šećera u krvi
English: Safety information on myelosuppression, infections, VOD overall and VOD post-HSCT, and death, which are known adverse events for MYLOTARG (see section 4.8 and Table 7), was obtained from literature.
Croatian: Informacije o sigurnosti primjene za mijelosupresiju, infekcije, VOD općenito i VOD nakon HSCT-a te smrt, poznate štetne događaje kod primjene lijeka MYLOTARG (vidjeti dio 4.8 i tablicu 7), prikupljene su iz literature.
English: In an embryo-foetal toxicity study lower foetal body weight, higher incidence of foetal wavy ribs, and lower incidence of foetal skeletal ossification were observed.
Croatian: U ispitivanju embriofetalne toksičnosti zabilježena je manja tjelesna težina fetusa, veća incidencija valovitih rebara u fetusa i manja incidencija osifikacije skeleta fetusa.
English: • Inflammation of the urinary bladder resulting in bleeding from the bladder
Croatian: • upala mokraćnog mjehura koja rezultira krvarenjem iz mjehura
English: The trial met its primary objective of demonstrating that MYLOTARG added in fractionated doses (3 mg/m2 × 3) to standard induction chemotherapy for patients with previously untreated de novo AML resulted in a statistically significant and clinically meaningful improvement in EFS.
Croatian: Ispitivanje je ispunilo svoj primarni cilj dokazivanja da lijek MYLOTARG dodan u podijeljenim dozama (3 mg/m2 × 3) standardnoj indukcijskoj kemoterapiji za bolesnike s prethodno neliječenim de novo AML-om dovodi do statistički značajnog i klinički važnog poboljšanja u preživljenju bez događaja.
English: Thus, the optimal dose of gemtuzumab ozogamicin for paediatric patients was not established (see section 4.2).
Croatian: Stoga nije bila određena optimalna doza gemtuzumab ozogamicina za pedijatrijske bolesnike (vidjeti dio 4.2).
English: In a male fertility study, effects on male reproduction included lower spermatogonia and spermatocytes, decreases in testicular spermatids and epididymal sperm, vacuolation of the nucleus in spermatids, and/or appearance of giant cells.
Croatian: U ispitivanju plodnosti mužjaka učinci na reprodukciju mužjaka uključivali su manji broj spermatogonija i spermatocita, smanjenja razina testikularnih spermatida i epididimalne sperme, vakuolizaciju jezgre u spermatida i/ili pojavu orijaških stanica.