FrancophonIA/ELRC3.0 huggingface dataset:
English: Delay treatment with MYLOTARG until recovery to a severity of no more than mild.
Croatian: Odgodite liječenje lijekom MYLOTARG sve dok stupanj nehematološke toksičnosti bude ne viši od blagog.
English: Effects on liver, kidney and male reproductive organs in rats, and on lymphoid tissues in monkeys (approximately 18 times for rats, and 36 times for monkeys, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168) were not reversible.
Croatian: Učinci na jetru, bubrege i muške reproduktivne organe u štakora te na limfatička tkiva u majmuna (izloženost u štakora približno 18 puta, a u majmuna 36 puta veća od kliničke izloženosti ljudi nakon treće doze od 3 mg/m2 na temelju vrijednosti AUC168) nisu bili reverzibilni.
English: Each carton contains 1 amber, glass vial, with rubber stopper and crimp seal with flip-off cap.
Croatian: Jedna kutija sadrži 1 staklenu bočicu boje jantara s gumenim čepom i prstenastim zatvaračem s flip-off kapicom.
English: The PK of gemtuzumab ozogamicin has not been studied in patients with severe renal impairment.
Croatian: Farmakokinetika gemtuzumab ozogamicina nije proučavana u bolesnika s teškim oštećenjem funkcije bubrega.
English: The study showed that addition of MYLOTARG to intensive chemotherapy improved EFS (3 years: 50.6% versus 44.0%; HR 0.838; 95% CI: 0.706, 0.995; p=0.0431) in de novo AML owing to a reduced relapse risk, with a trend towards longer OS in the MYLOTARG arm which was not statistically significant (3 years: 72.4% versus 67.6%; HR 0.904; 95% CI: 0.721, 1.133; p=0.3799).
Croatian: Ispitivanje je pokazalo da je dodavanje lijeka MYLOTARG intenzivnoj kemoterapiji poboljšalo preživljenje bez događaja (3 godine: 50,6 % naspram 44,0 %; HR 0,838; 95 % CI: 0,706; 0,995; p=0,0431) u de novo AML-u zbog smanjenog rizika od recidiva, uz trend prema duljem ukupnom preživljenju u skupini koja je primala lijek MYLOTARG što nije bilo statistički značajno (3 godine: 72,4 % naspram 67,6 %; HR 0,904; 95 % CI: 0,721; 1,133; p=0,3799).
English: Thrombocytopenia with platelet counts < 50,000/mm3 persisting 45 days after the start of therapy for responding patients (CR and incomplete platelet recovery [CRp]) occurred in 22 (20.4%) of patients.
Croatian: 3 koja je potrajala 45 dana nakon početka terapije za bolesnike koji su reagirali na terapiju (potpuna remisija i nepotpuni oporavak broja trombocita [CRp]) pojavila se u 22 (20,4 %) bolesnika.
English: p. Stomatitis includes the following reported PTs: Mucosal inflammation, Oropharyngeal pain, Stomatitis, Mouth ulceration, Oral pain, Oral mucosal blistering, Aphthous stomatitis, Tongue ulceration, Glossodynia, Oral mucosal erythema, Glossitis#, and Oropharyngeal blistering#.
Croatian: Stomatitis uključuje sljedeće zabilježene preporučene pojmove: upala sluznice, orofaringealna bol, stomatitis, ulceracije usta, bol u ustima, stvaranje mjehurića na sluznici usta, aftozni stomatitis, ulceracije jezika, glosodinija, eritem sluznice usta, glositis
English: When reconstituted to a 1 mg/mL concentration, the extractable content of one vial is 4.5 mg (4.5 mL).
Croatian: Kada se razrijedi na koncentraciju od 1 mg/ml, sadržaj koji se može izvući iz bočice iznosi 4,5 mg (4,5 ml).
English: Women of childbearing potential, or partners of females of childbearing potential should be advised to use 2 methods of effective contraception during treatment with MYLOTARG for at least 7 months (females) or 4 months (males) after the last dose.
Croatian: Ženama reproduktivne dobi ili partnerima žena reproduktivne dobi potrebno je savjetovati da koriste 2 metode učinkovite kontracepcije tijekom liječenja lijekom MYLOTARG i još najmanje 7 mjeseci (žene) ili 4 mjeseca (muškarci) nakon zadnje doze.
English: Effects on female reproductive organs and the eye in monkeys were adverse in the 12-week study (approximately 193 and 322 times, respectively, the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).
Croatian: Učinci na ženske reproduktivne organe i oko u majmuna bili su štetni u ispitivanju koje je trajalo 12 tjedana (pri izloženosti približno 193 odnosno 322 puta većoj od kliničke izloženosti ljudi nakon treće doze od 3 mg/m2 na temelju vrijednosti AUC168).
English: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of the CD33-directed monoclonal antibody (hP67.6; recombinant humanised immunoglobulin [Ig] G4, kappa antibody produced by mammalian cell culture in NS0 cells) that is covalently linked to the cytotoxic agent N-acetyl gamma calicheamicin.
Croatian: Gemtuzumab ozogamicin je konjugat antitijela i lijeka (engl. antibody-drug conjugate, ADC) sastavljen od monoklonskog antitijela usmjerenog na CD33 (hP67.6; rekombinantnog humaniziranog imunoglobulina [Ig] G4, kapa antitijela proizvedenog u kulturi stanica sisavaca u NS0 stanicama) koje je kovalentno vezano na citotoksičnu tvar N-acetil-gama-kalikeamicin.
English: #Singular cases.
Croatian: Pojedinačni slučajevi.
English: What you need to know before you are given MYLOTARG 3.
Croatian: Što morate znati prije nego počnete primati MYLOTARG 3. Kako će se MYLOTARG davati 4. Moguće nuspojave
English: When reconstituted to a 1 mg/mL concentration as directed, the extractable content of the vial is 4.5 mg (4.5 mL).
Croatian: Kada se prema uputama razrijedi na koncentraciju od 1 mg/ml, sadržaj koji se može izvući iz bočice iznosi 4,5 mg (4,5 ml).
English: There were no preneoplastic or neoplastic lesions observed in monkeys up to approximately 115 times the human clinical exposure after the third human dose of 3 mg/m2 based on AUC168).
Croatian: Nisu primijećene preneoplastične ili neoplastične lezije u majmuna pri izloženosti do približno 115 puta većoj od kliničke izloženosti ljudi nakon treće doze od 3 mg/m2 na temelju vrijednosti AUC168.
English: • If the reconstituted solution cannot be used immediately, it may be stored in the original vial for up to 6 hours in a refrigerator (2°C-8°C) with not more than 3 hours at room temperature (below 25°C).
Croatian: • Ako se rekonstituirana otopina ne može odmah upotrijebiti, može se čuvati u originalnoj bočici do 6 sati u hladnjaku (2 °C - 8 °C) uz najviše 3 sata na sobnoj temperaturi (ispod 25 °C).
English: In patients who experience VOD/SOS, MYLOTARG should be discontinued and patients treated according to standard medical practice.
Croatian: Liječenje lijekom MYLOTARG potrebno je trajno prekinuti u bolesnika koji razviju VOD/SOS te se ti bolesnici trebaju liječiti prema standardnoj medicinskoj praksi.
English: 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.
Croatian: 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.
English: N per study (range)
Croatian: Broj po ispitivanju (raspon)
English: daunorubicin cytarabine
Croatian: daunorubicin citarabin
English: Infusion lines made of PVC (DEHP- or non DEHP-containing), or polyethylene are recommended.
Croatian: Preporučuju se cjevčice za infuziju napravljene od PVC-a (koji sadrži DEHP ili koji ne sadrži DEHP) ili polietilena.
English: Nausea Stomatitisp
Croatian: • loša probava
English: Management of signs or symptoms of hepatic toxicity may require a dose interruption, or discontinuation of MYLOTARG (see section 4.2).
Croatian: Zbrinjavanje znakova ili simptoma jetrene toksičnosti može zahtijevati privremeni prekid doziranja ili trajni prekid liječenja lijekom MYLOTARG (vidjeti dio 4.2).
English: MYLOTARG should not be given if you:
Croatian: Nemojte primiti MYLOTARG:
English: 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.
Croatian: 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.
English: Hepatotoxicity, including life-threatening, and sometimes fatal hepatic failure and VOD/SOS have been reported in patients treated with MYLOTARG (see section 4.8).
Croatian: 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).
English: • The other ingredients are dextran 40, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous.
Croatian: • Druge pomoćne tvari su: dekstran 40, saharoza, natrijev klorid, natrijev dihidrogenfosfat hidrat, natrijev hidrogenfosfat, bezvodni.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, haemorrhage and infection.
Croatian: Najčešće (≥ 1%) nuspojave koje su dovele do trajnog prekida u ispitivanju kombiniranog liječenja bile su trombocitopenija, VOD, hemoragija i infekcija.
English: Complete blood counts should be monitored prior to each dose of MYLOTARG.
Croatian: Prije svake doze lijeka MYLOTARG potrebno je kontrolirati kompletnu krvnu sliku.
English: b. Based on the Cox Proportional Hazards Model Versus daunorubicin+cytarabine.
Croatian: Na temelju Coxovog modela proporcionalnih hazarda naspram daunorubicina + citarabin.
English: Use in patients with hepatic impairment
Croatian: Primjena u bolesnika s oštećenjem bubrega
English: After gemtuzumab ozogamicin binds to the target it is internalised and N-acetyl calicheamicin is released by hydrolytic cleavage.
Croatian: Nakon što se gemtuzumab ozogamicin veže na ciljno mjesto slijedi njegov unos, a N-acetil kalikeamicin se otpušta hidrolitičkim cijepanjem.
English: Haemoglobin decreased Platelets decreased White blood cells decreased Lymphocytes (absolute) decreased
Croatian: Smanjen broj trombocita Smanjen broj leukocita Smanjenje (apsolutnog) broja limfocita
English: MYLOTARG + daunorubicin + cytarabine daunorubicin + cytarabine
Croatian: MYLOTARG + daunorubicin + citarabin daunorubicin + citarabin
English: MYLOTARG has not been studied in patients with severe renal impairment.
Croatian: MYLOTARG nije ispitivan u bolesnika s teškim oštećenjem bubrega.
English: l. Hypotension includes the following reported PTs: Hypotension and Blood pressure decreased.
Croatian: Hipotenzija uključuje sljedeće zabilježene preporučene pojmove: hipotenzija i sniženi krvni tlak.
English: Sodium dihydrogen phosphate monohydrate Disodium hydrogen phosphate anhydrous
Croatian: Natrijev dihidrogenfosfat hidrat Natrijev hidrogenfosfat, bezvodni
English: 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).
Croatian: 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.
English: • Liver problems
Croatian: • Problemi s jetrom
English: Amber Type 1 glass vial, with butyl rubber stopper and crimp seal with flip-off cap containing 5 mg gemtuzumab ozogamicin.
Croatian: I boje jantara, s butilnim gumenim čepom te prstenastim zatvaračem s flip-off kapicom sadrži 5 mg gemtuzumab ozogamicina.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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
English: 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.
Croatian: 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).
English: AML with adverse-risk cytogenetics
Croatian: AML s lošim citogenetskim rizikom
English: Store the vial in the original carton to protect from light.
Croatian: Čuvati bočicu u originalnoj kutiji radi zaštite od svjetlosti.
English: m. Hypertension includes the following reported PTs: Hypertension and Blood pressure increased.
Croatian: Hipertenzija uključuje sljedeće zabilježene preporučene pojmove: hipertenzija i povišeni krvni tlak.
English: 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).
Croatian: 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).
English: Schedule modification for hyperleukocytosis
Croatian: Promjena rasporeda kod hiperleukocitoze
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide is primarily metabolised via nonenzymatic reduction.
Croatian: In vitro se N-acetil-gama-kalikeamicindimetilhidrazid prvenstveno metabolizira putem neenzimske redukcije.
English: 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).
Croatian: 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).
English: 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).
Croatian: 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).
English: c. Neutropenia includes the following reported PTs: Neutropenia, Granulocytopenia and Neutrophil count decreased.
Croatian: Neutropenija uključuje sljedeće zabilježene preporučene pojmove: neutropenija, granulocitopenija i smanjen broj neutrofila.
English: The primary metabolic pathway of gemtuzumab ozogamicin is anticipated to be hydrolytic release of N acetyl gamma calicheamicin dimethyl hydrazide.
Croatian: Očekuje se da je primarni metabolički put gemtuzumab ozogamicina hidrolitičko otpuštanje N-acetil-gama-kalikeamicindimetilhidrazida.
English: Each vial of powder for concentrate for solution for infusion contains 5 mg gemtuzumab ozogamicin.
Croatian: Jedna bočica praška za koncentrat za otopinu za infuziju sadrži 5 mg gemtuzumab ozogamicina.
English: (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%).
Croatian: 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 %).
English: Postpone MYLOTARG until recovery of total bilirubin to ≤ 2 × ULN and AST and ALT to
Croatian: Odgodite liječenje lijekom MYLOTARG dok se ukupni bilirubin ne vrati na ≤ 2 × GGN, a AST i ALT na ≤ 2,5 × GGN prije svake doze.
English: 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.
Croatian: In vitro su N-acetil-gama-kalikeamicindimetilhidrazid i gemtuzumab ozogamicin imali nizak potencijal za indukciju aktivnosti CYP1A2, CYP2B6 i CYP3A4 u klinički relevantnim koncentracijama.
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 3, 6, and 9
Croatian: 3 mg/m2 po dozi (do maksimalno jedne bočice od 5 mg) 3., 6. i 9. dana
English: MYLOTARG 5 mg powder for concentrate for solution for infusion gemtuzumab ozogamicin
Croatian: MYLOTARG 5 mg prašak za koncentrat za otopinu za infuziju gemtuzumab ozogamicin
English: Interactions with other medicinal products
Croatian: Interakcije lijekova
English: • 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.
Croatian: 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.
English: The diluted solution can be refrigerated at 2°C-8°C for up to 12 hours.
Croatian: Razrijeđena otopina može se čuvati u hladnjaku na 2 °C - 8 °C do 12 sati.
English: 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.
Croatian: 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.
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Day 1
Croatian: 3 mg/m2 po dozi (do maksimalno jedne bočice od 5 mg) 1. dana
English: Schedule modification for the treatment of hyperleukocytosis with cytarabine
Croatian: Tablica 2. Promjena rasporeda za liječenje hiperleukocitoze citarabinom Ciklus liječenja
English: • 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.
Croatian: 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.
English: **Including fatal adverse reactions in the post-marketing setting.
Croatian: Uključujući smrtonosne nuspojave nakon stavljanja lijeka u promet.
English: ***Frequency is based on laboratory values (Grade per NCI CTCAE v4.03).
Croatian: National Cancer Institute Common Terminology Criteria for Adverse Events, NCI CTCAE) verziji 4.03).
English: j. Tachycardia includes the following reported PTs: Tachycardia, Sinus tachycardia, Heart rate increased#, and
Croatian: Tahikardija uključuje sljedeće zabilježene preporučene pojmove: tahikardija, sinusna tahikardija, povećana frekvencija srca
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 32 and 35 days, respectively.
Croatian: 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.
English: 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.
Croatian: 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.
English: Effect on UGT substrates
Croatian: Učinak na supstrate UGT-a
English: The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in monotherapy studies were infection, haemorrhage, multi-organ failure, and VOD.
Croatian: Najčešće (≥ 1 %) nuspojave koje su dovele do trajnog prekida u ispitivanju monoterapije bile su infekcija, hemoragija, višeorgansko zatajenje i VOD.
English: Risk difference [95% CI]f p-valueg
Croatian: Razlika u riziku [95 % CI] p-vrijednost
English: r. Hyperbilirubinaemia includes the following reported PTs: Blood bilirubin increased and Hyperbilirubinaemia.
Croatian: Hiperbilirubinemija uključuje sljedeće zabilježene preporučene pojmove: povećane razine bilirubina u krvi i hiperbilirubinemija.