FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Pri obravnavi bolnikov s hudo okužbo, krvavitvijo ali drugimi učinki mielosupresije, vključno s hudo nevtropenijo ali perzistentno trombocitopenijo, bo morda potrebna zakasnitev odmerjanja ali trajna prekinitev zdravljenja z zdravilom MYLOTARG (glejte poglavji 4.2 in 4.4).
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide had a low potential to inhibit the activities of UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7 at clinically relevant concentrations.
Slovenian: In vitro je imel N-acetil-gama-kaliheamicin dimetilhidrazid v klinično pomembnih koncentracijah nizek potencial za zaviranje aktivnosti UGT1A1, UGT1A4, UGT1A6, UGT1A9 in UGT2B7.
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.
Slovenian: V študiji toksičnosti za zarodek in plod so pri plodu opazili manjšo telesno maso, večjo pojavnost valovite deformacije reber in manjšo pojavnost okostenevanja skeleta.
English: Saturation of a high percentage of CD33 antigenic sites is presumed to be required for maximum delivery of calicheamicin to leukaemic blast cells.
Slovenian: Za največje sproščanje kaliheamicina v levkemične blaste je predvidoma potrebna nasičenost visokega odstotka vezavnih mest za CD33.
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.
Slovenian: Okrajšave: AML = akutna mieloična levkemija; IZ = interval zaupanja; EFS = preživetje brez dogodkov; ELN = European LeukaemiaNet; mITT = modificirana populacija, ki so jo nameravali zdraviti; n = število; NE = ni mogoče oceniti.
English: Based on non-clinical findings, male and female fertility may be compromised by treatment with gemtuzumab ozogamicin (see section 5.3).
Slovenian: Podatkov o plodnosti pri bolnikih ni. Na podlagi nekliničnih ugotovitev lahko zdravljenje z gemtuzumab ozogamicinom ogrozi plodnost pri moških in ženskah (glejte poglavje 5.3).
English: x. Oedema includes the following reported PTs: Oedema, Face oedema, Oedema peripheral, Swelling face, Generalised oedema, and Periorbital oedema.
Slovenian: Edem vključuje naslednje PT, o katerih so poročali: edem, obrazni edem, periferni edem, otekanje obraza, generalizirani edem in periorbitalni edem.
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%).
Slovenian: Okužbe vključujejo sepso in bakteriemijo (25,6 %), glivično okužbo (10,5 %), okužbo spodnjih dihal (13,0 %), okužbo zgornjih dihal (4,3 %), bakterijsko okužbo (3,6 %), virusno okužbo (24,2 %), okužbo prebavil (3,3 %), okužbo kože (7,9 %) in druge okužbe (19,5 %).
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.
Slovenian: In vitro sta imela N-acetil-gama-kaliheamicin dimetilhidrazid in gemtuzumab ozogamicin v klinično pomembnih koncentracijah nizek potencial za zaviranje aktivnosti CYP1A2, CYP2A6 (testirano le z gemtuzumab ozogamicinom), CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4/5.
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.
Slovenian: V randomizirani študiji (COG AAML0531), v kateri so ocenjevali zdravljenje s samo standardno kemoterapijo ali kombinacijo standardne kemoterapije in zdravila MYLOTARG pri 1.063 na novo diagnosticiranih otrocih z AML (93,7 % bolnikov < 18 let) in mladih odraslih (6,3 % bolnikov), pri katerih je bila povprečna starost 8,9 leta (razpon: 0-29 let), so bolnike z AML de novo randomizirali bodisi v skupino, ki je prejela samo standardnih 5 ciklov kemoterapije, bodisi v skupino, ki je prejela enako kemoterapijo skupaj z 2 odmerkoma zdravila MYLOTARG (3 mg/m2/odmerek), danima enkrat v 1. indukcijskem ciklu in enkrat v 2. intenzifikacijskem ciklu.
English: j. Tachycardia includes the following reported PTs: Tachycardia, Sinus tachycardia, Heart rate increased#, and
Slovenian: Tahikardija vključuje naslednje PT, o katerih so poročali: tahikardija, sinusna tahikardija, povišan srčni utrip
English: Based on an analysis of potential risk factors, adult patients who received MYLOTARG as monotherapy, patients who had received an HSCT prior to gemtuzumab ozogamicin exposure were 2.6 times more likely (95% CI: 1.448, 4.769) to develop VOD compared to patients without HSCT prior to treatment with gemtuzumab ozogamicin; patients who had received an HSCT following treatment with gemtuzumab ozogamicin were 2.9 times more likely (95% CI: 1.502, 5.636) to develop VOD compared to patients without HSCT following treatment with gemtuzumab ozogamicin; and patients who had moderate/severe hepatic impairment at baseline were 8.7 times more likely (95% CI: 1.879, 39.862) to develop VOD compared to patients without moderate/severe hepatic impairment at baseline.
Slovenian: Na podlagi analize potencialnih dejavnikov tveganja pri odraslih bolnikih, ki so zdravilo MYLOTARG prejemali kot monoterapijo, je bila verjetnost za razvoj VOD pri bolnikih, pri katerih so pred izpostavljenostjo gemtuzumab ozogamicinu opravili PKMC, 2,6-krat večja (95 % IZ: 1,448; 4,769) v primerjavi z bolniki brez opravljene PKMC pred izpostavljenostjo gemtuzumab ozogamicinu; pri bolnikih, pri katerih so PKMC opravili po zdravljenju z gemtuzumab ozogamicinom, je bila verjetnost za razvoj VOD 2,9-krat večja (95 % IZ: 1,502; 5,636) v primerjavi z bolniki brez opravljene PKMC po zdravljenju z gemtuzumab ozogamicinom.
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.
Slovenian: Med indukcijsko fazo so pri 121 bolnikih (92,4 %) oziroma 118 bolnikih (90,1 %) zabeležili povečanje ANC na 500/mm 3 oziroma 1.000/mm 3.
English: Adverse reactions in patients who received MYLOTARG in monotherapy*** studies and post-marketing
Slovenian: Neželeni učinki pri bolnikih, ki so prejemali zdravilo MYLOTARG v študijah monoterapije in v obdobju trženja zdravila
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).
Slovenian: V študiji plodnosti pri samicah podgan so opazili nekoliko manjše število rumenih telesc in povečano smrtnost zarodkov ob prisotnosti toksičnosti za samice matere (pri približno 9,7-kratniku klinične izpostavljenosti pri ljudeh po tretjem odmerku 3 mg/m2 za človeka na podlagi vrednosti AUC168).
English: Gently invert the infusion container to mix the diluted solution.
Slovenian: Infuzijski vsebnik nežno zasukajte, da zmešate razredčeno raztopino.
English: Infusion should be interrupted immediately for patients who develop evidence of severe reactions, especially dyspnoea, bronchospasm, or clinically significant hypotension.
Slovenian: Pri bolnikih, pri katerih se pojavijo znaki hude reakcije, zlasti dispneja, bronhospazem ali klinično pomembna hipotenzija, je treba infundiranje takoj prekiniti.
English: Number of events, n (%) Median RFS in months [95% CI]a
Slovenian: število dogodkov, n (%) mediano RFS v mesecih [95 % IZ]
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).
Slovenian: Pri obravnavi bolnikov s hudo okužbo, krvavitvijo ali drugimi učinki mielosupresije, vključno s hudo nevtropenijo ali perzistentno trombocitopenijo, bo morda potrebna zakasnitev odmerjanja ali trajna prekinitev zdravljenja z zdravilom MYLOTARG (glejte poglavje 4.2).
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.
Slovenian: Mediano EFS je bilo 17,3 meseca (95 % IZ: 13,4; 30,0) v skupini, ki je prejemala zdravilo MYLOTARG, v primerjavi z 9,5 meseca (95 % IZ: 8,1; 12,0) v skupini, ki je prejemala samo DA; razmerje ogroženosti (HR - Hazard Ratio) je bilo 0,562 (95 % IZ: 0,415; 0,762); 2-stranska vrednost p = 0,0002 po testu log-rank.
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#.
Slovenian: Stomatitis vključuje naslednje PT, o katerih so poročali: vnetje sluznice, bolečina v ustih in žrelu, stomatitis, razjede v ustih, bolečine v ustih, mehurji na ustni sluznici, aftozni stomatitis, razjede na jeziku, glosodinija, eritem ustne sluznice, glositis
English: • After reconstitution, each ml of the concentrated solution contains 1 mg gemtuzumab ozogamicin.
Slovenian: • Po rekonstituciji 1 mililiter koncentrirane raztopine vsebuje 1 mg gemtuzumab ozogamicina.
English: **Including fatal adverse reactions in the post-marketing setting.
Slovenian: Vključno z neželenimi reakcijami s smrtnim izidom v obdobju trženja zdravila.
English: Each vial of powder for concentrate for solution for infusion contains 5 mg gemtuzumab ozogamicin.
Slovenian: Ena viala praška za koncentrat za raztopino za infundiranje vsebuje 5 mg gemtuzumab ozogamicina.
English: MYLOTARG has not been studied in patients with severe renal impairment.
Slovenian: Zdravila MYLOTARG pri bolnikih s hudo ledvično okvaro niso preučevali.
English: MYLOTARG + daunorubicin + cytarabine daunorubicin + cytarabine
Slovenian: GO + daunorubicin + citarabin daunorubicin + citarabin
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).
Slovenian: Če zdravila ne morete uporabiti takoj, lahko razredčeno raztopino hranite v hladilniku (2 °C - 8 °C) največ 18 ur od prvega predrtja viale in največ 6 ur na sobni temperaturi (do 25 °C).
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide is primarily metabolised via nonenzymatic reduction.
Slovenian: N-acetil-gama-kaliheamicin dimetilhidrazid se in vitro primarno presnavlja preko neencimske redukcije.
English: • If platelet count recovers to ≥ 100,000/mm3 within 14 days following the planned start date of the consolidation course: initiate consolidation therapy (see as described in Table 1).
Slovenian: 14 dneh po načrtovanem datumu začetka konsolidacijskega cikla: uvedite konsolidacijsko zdravljenje (glejte opis v preglednici 1).
English: Infection*a
Slovenian: *a
English: No cases of overdose with MYLOTARG were reported in clinical experience.
Slovenian: V kliničnih izkušnjah niso poročali o primerih prevelikega odmerjanja zdravila MYLOTARG.
English: Because of this limited data collection, laboratory data from the combination therapy study are included in Table 5.
Slovenian: Zaradi te omejene zbirke podatkov so za popolno predstavitev neželenih učinkov laboratorijski podatki iz študije kombiniranega zdravljenja vključeni v preglednico 5, informacije o neželenih učinkih zdravila iz študij monoterapije in izkušenj v obdobju trženja zdravila pa so predstavljene v preglednici 6.
English: Dose modifications
Slovenian: Prilagoditve odmerkov
English: MYLOTARG 5 mg powder for concentrate for solution for infusion
Slovenian: MYLOTARG 5 mg prašek za koncentrat za raztopino za infundiranje
English: Management of signs or symptoms of hepatic toxicity may require a dose interruption, or discontinuation of MYLOTARG (see section 4.2).
Slovenian: Za obvladovanje znakov in simptomov hepatotoksičnosti bo morda potrebna prekinitev odmerjanja ali prekinitev zdravljenja z zdravilom MYLOTARG (glejte poglavje 4.2).
English: Grade 4 bleeding/haemorrhagic reactions were reported in 4 (3.1%) patients (gastrointestinal haemorrhage, haemorrhage, and pulmonary alveolar haemorrhage [2 patients]).
Slovenian: O krvavitvah/hemoragičnih reakcijah stopnje 4 so poročali pri 4 bolnikih (3,1 %) (krvavitev v prebavilih, hemoragija in pljučna alveolarna krvavitev [2 bolnika]).
English: Respiratory, thoracic and mediastinal disorders Very common Dyspnoean
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti dispneja neznana intersticijska pljučnica
English: Fatal reports of TLS complicated by acute renal failure have been reported in the post-marketing setting.
Slovenian: V obdobju trženja zdravila so poročali o primerih TLS s smrtnim izidom, pri katerih je prišlo do zapleta zaradi akutne ledvične odpovedi.
English: Use in AML with adverse-risk cytogenetics
Slovenian: Uporaba pri AML z neugodnim citogenetskim tveganjem
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Day 1
Slovenian: 3 mg/m2/odmerek (do največ ene 5 mg viale) na 1. dan
English: r. Hyperbilirubinaemia includes the following reported PTs: Blood bilirubin increased and Hyperbilirubinaemia.
Slovenian: Hiperbilirubinemija vključuje naslednja PT, o katerih so poročali: zvečanje vrednosti bilirubina v krvi in hiperbilirubinemija.
English: Amber Type 1 glass vial, with butyl rubber stopper and crimp seal with flip-off cap containing 5 mg gemtuzumab ozogamicin.
Slovenian: Viala iz rjavega stekla tipa I z zamaškom iz butilne gume in objemno zaporko s snemljivim pokrovčkom, ki vsebuje 5 mg gemtuzumab ozogamicina.
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.
Slovenian: Gemtuzumab ozogamicin je imunokonjugat (ADC - Antibody-Drug Conjugate), sestavljen iz monoklonskega protitelesa, ki je usmerjeno proti CD33 (hP67.6) in je kovalentno vezano na citotoksično učinkovino N-acetil-gama-kaliheamicin.
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.
Slovenian: V študiji kombiniranega zdravljenja pri bolnikih s predhodno nezdravljeno AML de novo, ki so jo zdravili s frakcioniranim odmerjanjem gemtuzumab ozogamicina v kombinaciji s kemoterapijo, so pri 131 bolnikih (100 %), 124 bolnikih (96,1 %) oziroma 131 bolnikih (100 %) opazili zmanjšanje števila levkocitov, nevtrofilcev oziroma trombocitov stopnje 3/4.
English: MYLOTARG 5 mg powder for concentrate for solution for infusion gemtuzumab ozogamicin
Slovenian: MYLOTARG 5 mg prašek za koncentrat za raztopino za infundiranje gemtuzumab ozogamicin
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).
Slovenian: 12-tedenski študiji so opazili učinke na rodila pri samicah opic (atrofija jajčnikov, jajcevoda, maternice in materničnega vratu; približno 193-kratnik klinične izpostavljenosti pri ljudeh po tretjem odmerku 3 mg/m
English: Each vial contains 5 mg of gemtuzumab ozogamicin.
Slovenian: Ena viala vsebuje 5 mg gemtuzumab ozogamicina.
English: c. Neutropenia includes the following reported PTs: Neutropenia, Granulocytopenia and Neutrophil count decreased.
Slovenian: Nevtropenija vključuje naslednje PT, o katerih so poročali: nevtropenija, granulocitopenija in zmanjšanje števila nevtrofilcev.
English: 60 mg/m2/day on Day 3 to Day 5
Slovenian: 60 mg/m2/dan od 3. do 5. dne
English: N-acetyl gamma calicheamicin DMH (the released cytotoxin) was found to be mutagenic and clastogenic.
Slovenian: Ugotovili so, da je N-acetil-gama-kaliheamicin DMH (sproščeni citotoksin) mutagen in klastogen.
English: Event-free survival by investigator assessment by AML risk classifications from study ALFA-0701 (mITT Population)
Slovenian: Celokupno preživetje po klasifikacijah tveganja za AML iz študije ALFA0701 (populacija mITT)
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 1, 4, and 7
Slovenian: 3 mg/m2/odmerek (do največ ene 5 mg viale) na 1., 4. in 7. dan
English: During treatment, patients should be monitored for signs and symptoms of infection, bleeding/haemorrhage, or other effects of myelosuppression.
Slovenian: Pred vsakim odmerkom zdravila MYLOTARG je treba spremljati celotno krvno sliko, med zdravljenjem pa je treba bolnike spremljati glede znakov in simptomov okužbe, krvavitve ter drugih učinkov mielosupresije.
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 36.5 and 43 days, respectively.
Slovenian: Mediani čas do povečanja števila trombocitov na 50.000/mm 3 oziroma 100.000/mm 3 je bil 36,5 dni oziroma 43 dni.
English: Dosing regimens for MYLOTARG in combination with chemotherapy
Slovenian: Režimi odmerjanja za zdravilo MYLOTARG v kombinaciji s kemoterapijo Potek zdravljenja zdravilo MYLOTARG daunorubicin citarabin
English: Dose modification for adverse reactions
Slovenian: Prilagajanje odmerkov v primeru neželenih učinkov
English: Discontinuation of treatment should be strongly considered for patients who develop signs or symptoms of anaphylaxis, including severe respiratory symptoms or clinically significant hypotension (see section 4.2).
Slovenian: Pri bolnikih, pri katerih se pojavijo znaki ali simptomi anafilaksije, vključno s hudimi respiratornimi simptomi ali klinično pomembno hipotenzijo, je treba skrbno razmisliti o prekinitvi zdravljenja (glejte poglavje 4.2).
English: How to store MYLOTARG
Slovenian: Kako dajemo zdravilo MYLOTARG
English: Postpone MYLOTARG until recovery of total bilirubin to ≤ 2 × ULN and AST and ALT to
Slovenian: Odložite zdravljenje z zdravilom MYLOTARG, dokler se celokupni bilirubin pred vsakim odmerkom ne izboljša na ≤ 2 × ZMN, vrednosti AST in ALT pa na ≤ 2,5 × ZMN.
English: Only DNR and AraC should be administered during the second induction cycle, at the following recommended dosing: DNR 35 mg/m2/day on Days 1 and 2, and AraC 1 g/m2 every 12 hours, on Day 1 to Day 3.
Slovenian: Med drugim ciklom indukcijskega zdravljenja lahko dajemo samo daunorubicin in citarabin z naslednjim priporočenim odmerjanjem: 35 mg/m2/dan daunorubicina na 1. in 2. dan ter
English: • Redness of the skin
Slovenian: • pordelost kože
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.
Slovenian: In vitro sta imela N-acetil-gama-kaliheamicin dimetilhidrazid in gemtuzumab ozogamicin v klinično pomembnih koncentracijah nizek potencial za induciranje aktivnosti CYP1A2, CYP2B6 in CYP3A4.
English: White to off-white cake or powder.
Slovenian: bela do belkasta pogača ali prašek
English: • Each vial contains 5 mg gemtuzumab ozogamicin.
Slovenian: • Ena viala vsebuje 5 mg gemtuzumab ozogamicina.
English: AML with adverse-risk cytogenetics
Slovenian: AML z neugodnim citogenetskim tveganjem
English: • Gently swirl the vial to aid dissolution.
Slovenian: • Vialo narahlo sučite, da pospešite raztapljanje.
English: Each carton contains 1 amber, glass vial, with rubber stopper and crimp seal with flip-off cap.
Slovenian: Ena škatla vsebuje 1 vialo iz rjavega stekla z gumijastim zamaškom in objemno zaporko s snemljivim pokrovčkom.
English: • Prolonged clotting time
Slovenian: • podaljšan čas strjevanja krvi
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial
Slovenian: prašek za koncentrat za raztopino za infundiranje 1 viala
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.
Slovenian: V 23,5 % študij je večina bolnikov prejemala frakcionirane odmerke (3 mg/m2 na 1.,
English: • Pain in the abdomen
Slovenian: • bolečina v trebuhu
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.
Slovenian: 3 v 14 dneh po načrtovanem datumu začetka konsolidacijskega cikla: zdravila MYLOTARG ne smete ponovno uvesti, konsolidacijsko zdravljenje pa naj vključuje le daunorubicin in citarabin.
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.
Slovenian: • Odmerke je treba zmešati do koncentracije med 0,075 mg/ml in 0,234 mg/ml v skladu z naslednjimi navodili: o Odmerke, manjše od 3,9 mg, je treba pripraviti za dajanje z brizgo: rekonstituirano raztopino zdravila MYLOTARG dodajte v brizgo z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje, da dobite končno koncentracijo med 0,075 mg/ml in 0,234 mg/ml.
English: The median time to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 was 25 days.
Slovenian: Mediani čas do povečanja ANC na 500/mm oziroma 1.000/mm 3 je bil 25 dni.
English: Based on a population PK analysis, the clearance of gemtuzumab ozogamicin (hP67.6 antibody and unconjugated calicheamicin) is not expected to be affected by mild hepatic impairment status, as defined by National Cancer Institute Organ Dysfunction Working Group (NCI ODWG).
Slovenian: Na podlagi populacijske farmakokinetične analize blaga okvara jeter, kot jo opredeljuje delovna skupina Nacionalnega inštituta za rakava obolenja za področje motenj delovanja organov (NCI ODWG - National Cancer Institute Organ Dysfunction Working Group), predvidoma ne vpliva na očistek gemtuzumab ozogamicina (protitelo hP67.6 in nekonjugirani kaliheamicin).
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 32 and 35 days, respectively.
Slovenian: Mediani čas do povečanja števila trombocitov na 50.000/mm 3 oziroma 100.000/mm 3 je bil 32 dni oziroma 35 dni.
English: 1 g/m2/every 12 hours on Day 1 to Day 3
Slovenian: 1 g/m2/vsakih 12 ur od 1. do 3. dne
English: 2-hour period under close clinical monitoring, including pulse, blood pressure, and temperature.
Slovenian: Rekonstituirano in razredčeno raztopino je treba dajati intravensko v obliki 2-urne infuzije ob skrbnem kliničnem spremljanju, vključno s spremljanjem srčnega utripa, krvnega tlaka in telesne temperature.
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).
Slovenian: Pri bolnikih, ki so jih zdravili z zdravilom MYLOTARG, so poročali o hepatotoksičnosti, vključno z življenjsko ogrožajočo in včasih smrtno odpovedjo jeter in VOD/SOS (glejte poglavje 4.8).
English: 1 g/m2/every 12 hours on Day 1 to Day 4
Slovenian: 1 g/m2/vsakih 12 ur od 1. do 4. dne