FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovak: 9/l alebo vyšším v periférnej krvi v prípade nepodania transfúzie, sa odporúčajú maximálne 2 konsolidačné fázy intravenózneho DNR (60 mg/m počas 1 dňa [prvá fáza] alebo 2 dní [druhá fáza]) v kombinácii s intravenóznym AraC (1 g/m každých 12 hodín, podaným infúzne počas 2 hodín v 1. až 4. deň) a liekom MYLOTARG (3 mg/m na dávku podaných infúzne v priebehu 2 hodín až do maximálnej dávky jednej 5 mg injekčnej liekovky v 1. deň).
English: Relapse-free survival (by Investigator)
Slovak: Prežívanie bez relapsu (podľa investigátora)
English: What MYLOTARG is and what it is used for
Slovak: MYLOTARG sa má používať len u
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).
Slovak: U pacientov liečených liekom MYLOTARG bola hlásená hepatotoxicita vrátane život ohrozujúceho a niekedy smrteľného zlyhania pečene a VOD/SOS (pozri časť 4.8).
English: • After reconstitution, each ml of the concentrated solution contains 1 mg gemtuzumab ozogamicin.
Slovak: Po rekonštitúcii obsahuje každý ml koncentrovaného roztoku 1 mg gemtuzumab ozogamicínu.
English: Infection*a
Slovak: *a
English: a. Infection includes Sepsis and Bacteraemia (53.4%), Fungal infection (15.3%), Lower respiratory tract infection
Slovak: Infekcia zahŕňa sepsu a bakteriémiu (53,4
English: The median time to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 was 25 days.
Slovak: Medián času obnovy počtu neutrofilov na ANC 500/mm 3 a 1 000/mm 3 bol 25 dní.
English: Schedule modification for the treatment of hyperleukocytosis with cytarabine
Slovak: Úprava schémy podávania pri liečbe hyperleukocytózy cytarabínom Fáza liečby MYLOTARG daunorubicín cytarabín hydroxymočovina
English: Overall, the median age of patients was 62 years (range 50 to 70 years) and most patients (87.8%) had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 at baseline.
Slovak: Celkovo bol medián veku pacientov 62 rokov (rozsah 50 až 70 rokov) a väčšina pacientov (87,8
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.
Slovak: Na základe analýzy možných rizikových faktorov bola u dospelých pacientov, ktorým bol podávaný liek MYLOTARG ako monoterapia, a pacientov, ktorí podstúpili HSCT pred expozíciou gemtuzumab ozogamicínu, 2,6-násobne vyššia pravdepodobnosť (95 % CI: 1,448; 4,769) rozvoja VOD v porovnaní s pacientmi, ktorí nepodstúpili HSCT pred liečbou gemtuzumab ozogamicínom.
English: • Prior to reconstitution, allow the vial to reach room temperature (below 25°C) for approximately 5 minutes.
Slovak: Pred rekonštitúciou nechajte injekčnú liekovku približne 5 minút temperovať na izbovú teplotu (do 25 °C).
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 1, 4, and 7
Slovak: 3 mg/m2/dávka (maximálne jedna 5 mg injekčná liekovka) v 1., 4. a 7. Deň
English: The number of patients with persistent thrombocytopenia remained similar across treatment courses (8 [7.4%] patients at the induction phase and 8 [8.5%] patients at the consolidation 1 phase and 10 [13.2%] patients at the consolidation 2 phase).
Slovak: Počet pacientov s pretrvávajúcou trombocytopéniou zostal podobný v priebehu liečebných fáz (8 [7,4
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).
Slovak: Pokiaľ sa rekonštituovaný roztok nemôže použiť okamžite, môže sa až 6 hodín uchovávať v pôvodnej injekčnej liekovke v chladničke (2 °C - 8 °C) a maximálne 3 hodiny pri izbovej teplote (do 25 °C).
English: Use in AML with adverse-risk cytogenetics
Slovak: Použitie u pacientov s AML s nepriaznivou cytogenetikou
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.
Slovak: In vitro mali N-acetyl-gama-kalicheamicíndimetylhydrazid a gemtuzumab ozogamicín nízky potenciál indukovať aktivity CYP1A2, CYP2B6 a CYP3A4 v klinicky významných koncentráciách.
English: Risk difference [95% CI]f p-valueg
Slovak: Rozdiel rizík [95 % CI] p-hodnota
English: Each vial contains 5 mg of gemtuzumab ozogamicin.
Slovak: Každá injekčná liekovka obsahuje 5 mg gemtuzumab ozogamicínu.
English: Number of events, n (%) Median RFS in months [95% CI]a
Slovak: Medián EFS v mesiacoch [95 % CI]a
English: No dose adjustment is required in patients with mild to moderate renal impairment.
Slovak: U pacientov s miernou až stredne závažnou poruchou funkcie obličiek nie je potrebná žiadna úprava dávkovania.
English: y. Fatigue includes the following reported PTs: Fatigue, Asthenia, Lethargy, and Malaise.
Slovak: Únava zahŕňa nasledujúce hlásené PT: únavu, asténiu, letargiu a malátnosť.
English: Add the reconstituted MYLOTARG solution to a syringe with sodium chloride 9 mg/mL (0.9%) solution for injection to a final concentration between 0.075 mg/mL to 0.234 mg/mL.
Slovak: Pridajte rekonštituovaný roztok lieku MYLOTARG do injekčnej striekačky s injekčným roztokom chloridu sodného s koncentráciou 9 mg/ml (0,9
English: 2-hour period under close clinical monitoring, including pulse, blood pressure, and temperature.
Slovak: Rekonštituovaný a zriedený roztok sa má podávať intravenózne infúziou počas 2 hodín za podrobného klinického monitorovania zahŕňajúceho monitorovanie pulzu, krvného tlaku a teploty.
English: Overall, the incidence rate of ADA development after MYLOTARG treatment was < 1% across the 4 clinical studies with ADA data.
Slovak: Celkovo bola incidencia tvorby ADA po liečbe liekom MYLOTARG < 1
English: daunorubicin + cytarabine (N=137)
Slovak: daunorubicín + cytarabín (N =
English: The diluted solution can be refrigerated at 2°C-8°C for up to 12 hours.
Slovak: Zriedený roztok sa môže uchovávať v chladničke, pri 2 °C8 °C maximálne 12 hodín.
English: 200 mg/m2/day on Day 1 to Day 7
Slovak: 200 mg/m2/deň v 1. až 7. deň
English: Amber Type 1 glass vial, with butyl rubber stopper and crimp seal with flip-off cap containing 5 mg gemtuzumab ozogamicin.
Slovak: I s butylovou gumovou zátkou, zapečatením po okrajoch a ľahko otvárateľným viečkom obsahujúca 5 mg gemtuzumab ozogamicínu.
English: Gently invert the infusion container to mix the diluted solution.
Slovak: Jemne prevráťte infúzny vak, aby ste premiešali zriedený roztok.
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).
Slovak: Analýza zahŕňala 405 pacientov s nasledujúcimi kategóriami poruchy funkcie pečene podľa NCI ODWG: mierna (B1, n =
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.
Slovak: V štúdii s kombinovanou liečbou u pacientov s predtým neliečenou de novo AML, ktorí boli liečení frakcionovanými dávkami gemtuzumab ozogamicínu v kombinácii s chemoterapiou, bolo pozorované zníženie počtu leukocytov stupňa 3/4 u 131 (100
English: Infusion should be interrupted immediately for patients who develop evidence of severe reactions, especially dyspnoea, bronchospasm, or clinically significant hypotension.
Slovak: V prípade rozvoja závažných reakcií u pacientov, obzvlášť dýchavičnosti, bronchospazmu alebo klinicky významnej hypotenzie, je potrebné infúziu ihneď prerušiť.
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.
Slovak: 9/l pre neutrofily) bol v rozsahu 42 - 48 dní pre trombocyty a 30 - 37 dní pre neutrofily.
English: Abbreviations: C=cytarabine; D=daunorubicin; GO=gemtuzumab ozogamicin; mITT=modified intent-to-treat.
Slovak: C = cytarabín; D = daunorubicín; GO = gemtuzumab ozogamicín; mITT
English: Persistent thrombocytopenia (Platelets < 100,000/mm3 at the planned start date of the consolidation course)
Slovak: Perzistentná trombocytopénia (Počet trombocytov < 100 000/mm
English: - If you get any side effects, talk to your doctor or nurse.
Slovak: - Ak sa u vás vyskytne akýkoľvek vedľajší účinok, obráťte sa na svojho lekára alebo zdravotnú informácii.
English: Dose modifications for non-haematological toxicities Non-haematological toxicities Dose modifications VOD/SOS
Slovak: Nehematologické toxicity Úpravy dávkovania VOD/SOS
English: Consolidation Course 1a,b
Slovak: Konsolidačná fáza 1
English: 60 mg/m2/day on Day 3 to Day 5
Slovak: 60 mg/m2/deň v 3. až 5. Deň
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.
Slovak: Účinky na pečeň, obličky a samčie reprodukčné orgány u potkanov a na lymfatické tkanivá u opíc (u potkanov približne pri 18-násobku a u opíc približne pri 36-násobku klinickej expozície u ľudí po tretej ľudskej dávke 3 mg/m2 na základe
English: An in-line, low protein-binding 0.2 micron polyethersulphone (PES) filter must be used for infusion of MYLOTARG.
Slovak: Pri infúzii lieku MYLOTARG sa musí použiť in-line filter slabo viažuci bielkoviny s pórmi s priemerom 0,2 μm vyrobený z polyétersulfónu (PES).
English: MYLOTARG contains the active substance gemtuzumab ozogamicin, an anticancer medicine, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells.
Slovak: Čo je liek MYLOTARG a na čo sa používa monoklonálnou protilátkou spojenou s látkou určenou na usmrcovanie nádorových buniek.
English: In vitro, the binding N-acetyl gamma calicheamicin dimethyl hydrazide to human plasma proteins is approximately 97%.
Slovak: In vitro je väzba N-acetyl-gama-kalicheamicíndimetylhydrazidu na proteíny ľudskej plazmy približne 97 %. In vitro je N-acetyl-gama-kalicheamicíndimetylhydrazid substrátom P-glykoproteínu (P-gp).
English: There have been reports of fatal infusion reactions in the post-marketing setting.
Slovak: Po uvedení lieku na trh boli hlásené smrteľné reakcie na infúziu.
English: Total bilirubin > 2 × ULN and AST and/or ALT > 2.5 × ULN
Slovak: Hladina celkového bilirubínu > 2 ×
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.
Slovak: Gemtuzumab ozogamicín je konjugát protilátky a liečiva (ADC, antibody-drug conjugate) skladajúci monoklonálnej protilátky namierenej proti CD33 (hP67,6; kappa reťazec rekombinantného cytotoxickú látku N-acetyl-gama-kalicheamicín.
English: Abbreviat ion: P T =preferred t erm.
Slovak: Skratka: PT = preferované termíny.
English: Haemorrhage*b
Slovak: Frakcionovaný b
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.
Slovak: 3) sa odporúča 48 hodín pred podaním lieku MYLOTARG na zníženie počtu periférnych bielych krviniek cytoredukcia buď leukaferézou, perorálnym podaním hydroxymočoviny alebo AraC s alebo bez hydroxymočoviny.
English: Consolidation Course 2a,b
Slovak: Konsolidačná fáza 2
English: • The active substance is gemtuzumab ozogamicin.
Slovak: mg gemtuzumab ozogamicínu.
English: Skin and subcutaneous tissue disorders Very common Rashu
Slovak: Buddov-Chiariho syndróm Poruchy kože a podkožného tkaniva Veľmi časté
English: e. Leukopenia includes the following reported PTs: Leukopenia and White blood cell count decreased.
Slovak: Leukopénia zahŕňa nasledujúce hlásené PT: leukopéniu a znížený počet leukocytov.
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 36.5 and 43 days, respectively.
Slovak: Medián času obnovy počtu trombocytov na hodnotu 50 000/mm 3 bol 36,5 dní a na hodnotu 100 000/mm 3 43 dní.
English: • Liver failure
Slovak: • zlyhanie pečene,
English: If not used immediately, store at room temperature (below 25°C) for up to 6 hours, which includes the 2-hour infusion time and 1 hour, if needed, to allow the refrigerated diluted solution to equilibrate to room temperature (below 25°C).
Slovak: Táto doba zahŕňa 2 hodiny na podávanie infúzie a, ak je to potrebné, 1 hodinu, počas ktorej sa schladený zriedený roztok zohreje na izbovú teplotu (do 25 °C).
English: k. Haemorrhages include Central nervous system haemorrhage (5.1%), Upper gastrointestinal haemorrhage (21.3%),
Slovak: %), krvácanie do hornej časti gastrointestinálneho traktu (21,3
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.
Slovak: % pacientov); priemerný vek pacientov bol 8,9 roka (rozsah: 0 - 29 rokov), boli pacienti s de novo AML náhodne zaradení buď do skupiny liečenej štandardnou chemoterapiou skladajúcou sa z 5 cyklov alebo do skupiny liečenej rovnakou chemoterapiou s 2 dávkami lieku MYLOTARG (3 mg/m2/dávka) podanými jedenkrát v indukčnom cykle 1 a jedenkrát v intenzifikačnom cykle 2.
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.
Slovak: Skratky: AML = akútna myeloblastová leukémia; CI = interval spoľahlivosti; EFS = prežívanie bez príhody; ELN =
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.
Slovak: %) pacientov vrátil počet neutrofilov na hodnotu 500/mm 3 a u 91 (94
English: In the combination therapy study ALFA-0701, clinically relevant serious adverse reactions were hepatotoxicity, including VOD/SOS (3.8%), haemorrhage (9.9%), severe infection (41.2%), and tumour lysis syndrome (1.5%).
Slovak: V štúdii s kombinovanou liečbou ALFA-0701 boli klinicky významné závažné nežiaduce reakcie hepatotoxicita vrátane VOD/SOS (3,8
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.
Slovak: 3, je potrebné prehodnotiť podanie konsolidačnej liečby a vykonať BMA na opätovné posúdenie stavu pacienta.
English: • Infections (signs of a low number of white blood cells known as neutrophils) Some infections may be serious and can be due to viruses, bacteria, or other causes that may be life-threatening.
Slovak: Niektoré infekcie môžu byť závažné a môžu byť spôsobené vírusmi, baktériami alebo inými príčinami, ktoré môžu byť život ohrozujúce.
English: Non-fractionatedb MYLO TARG
Slovak: Nefrakcionovaný MYLOTARG
English: Overall, 29 (5.5%) of patients in the MYLOTARG arm and 15 (2.8%) patients in the comparator arm died during remission.
Slovak: %) pacientov v ramene s liekom MYLOTARG a 15 (2,8
English: Neutrophils decreased Hyperglycaemia Aspartate aminotransferase (AST) increas ed Prothrombin time increased Activated partial thromboplastin time prolonged Alkaline phosphatase increased
Slovak: Predĺžený aktivovaný parciálny tromboplastínový čas Zvýšená hladina alkalickej fosfatázy
English: Fatal severe infection was reported in 2 (1.53%) patients in the MYLOTARG arm and 4 (2.92%) patients in the control arm.
Slovak: %) pacientov v ramene lieku MYLOTARG a u 4 (2,92
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).
Slovak: 0,0431) pri de novo AML v dôsledku zníženého rizika relapsu s tendenciou k dlhšiemu OS v ramene lieku MYLOTARG, ktoré nebolo štatisticky významné (3 ročné: 72,4 % oproti 67,6 %; HR 0,904; 95 %
English: 1 g/m2/every 12 hours on Day 1 to Day 3
Slovak: 1 g/m2/každých 12 hodín v 1. deň až 3. deň
English: Hazard ratio [95% CI]b p-valuec
Slovak: Miera rizika [95 % CI]b p-hodnotac
English: MYLOTARG should be used only in patients eligible to receive intensive induction chemotherapy.
Slovak: používaním dispozícii kompletné resuscitačné pacientov vhodných na intenzívnu indukčnú chemoterapiu.
English: d. Anaemia includes the following reported PTs: Anaemia and Haemoglobin decreased.
Slovak: Anémia zahŕňa nasledujúce hlásené PT: anémiu a zníženú hladinu hemoglobínu.
English: Nausea Stomatitisp
Slovak: ZATRIEDENIE LIEKU
English: j. Tachycardia includes the following reported PTs: Tachycardia, Sinus tachycardia, Heart rate increased#, and
Slovak: Tachykardia zahŕňa nasledujúce hlásené PT: tachykardiu, sínusovú tachykardiu, zrýchlenú frekvenciu srdca a supraventrikulárnu tachykardiu k.
English: Hepatobiliary disorders Very common Transaminases increasedq Hyperbilirubinaemiar
Slovak: Zvýšené hladiny transamináz Hyperbilirubinémia Časté
English: • Mouth inflammation
Slovak: • zápal pažeráka,
English: Pfizer Luxembourg SARL filiāle Latvijā
Slovak: Pfizer Luxembourg SARL Eesti filiaal Tel:
English: Hepatic impairment
Slovak: Venookluzívna choroba pečene
English: Unknown Inters titial pneumonia*
Slovak: Intersticiálna pneumónia Poruchy gastrointestinálneho traktu
English: Each vial of powder for concentrate for solution for infusion contains 5 mg gemtuzumab ozogamicin.
Slovak: prášku na infúzny koncentrát obsahuje 5 mg gemtuzumab ozogamicínu.
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 32 and 35 days, respectively.
Slovak: Medián času obnovy počtu trombocytov na hodnotu 50 000/mm 3 bol 32 dní a na hodnotu 100 000/mm 3 35 dní.
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.
Slovak: Štúdia splnila svoj primárny cieľ preukázať, že pridanie lieku MYLOTARG vo frakcionovaných dávkach (3 mg/m2 ×
English: See also section 6.3 for dilution, storage, and infusion information.
Slovak: Pre informácie o riedení, uchovávaní a infúznom podávaní pozri tiež časť 6.3.
English: 1 g/m2/every 12 hours on Day 1 to Day 4
Slovak: 1 g/m2/každých 12 hodín v 1. až 4. deň
English: h. Infusion related reaction includes the following reported PTs: Infusion related reaction, Urticaria, Hypersensitivity,
Slovak: Reakcia súvisiaca s infúziou zahŕňa nasledujúce hlásené PT: reakciu súvisiacu s infúziou, urtikáriu, precitlivenosť, bronchospazmus, precitlivenosť na lieky a urtikáriu v mieste vpichu i.
English: Effect of gemtuzumab ozogamicin on other medicinal products Effect on CYP substrates
Slovak: Vplyv gemtuzumab ozogamicínu na iné lieky
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.
Slovak: %) pacientov zdokumentovaný návrat absolútneho počtu neutrofilov (ANC - absolute neutrophil count) na 500/mm 3 a u 118 (90,1
English: SN
Slovak: CR
English: Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500
Slovak: Pfizer Luxembourg SARL filiāle Latvijā Tel: + 371 670 35 775
English: Ratec
Slovak: Únava
English: Grade 4 bleeding/haemorrhagic reactions were reported in 4 (3.1%) patients (gastrointestinal haemorrhage, haemorrhage, and pulmonary alveolar haemorrhage [2 patients]).
Slovak: %) pacientov (gastrointestinálne krvácanie, krvácanie a pľúcne alveolárne krvácanie [2 pacienti]).
English: 35 mg/m2/day on Day 1 to Day 2
Slovak: 35 mg/m 2/deň v 1. deň až
English: Epistaxis (28.5%).
Slovak: %), krvácanie do podkožia (28,5
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.
Slovak: %) pacientov vrátil počet neutrofilov na hodnotu 500/mm 3 a u 79 (96,3
English: The median times to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 were 21 and 25 days, respectively.
Slovak: Medián času obnovy ANC na hodnotu 500/mm 3 bol 21 dní a na hodnotu 1 000/mm 3 25 dní.
English: MYLOTARG 5 mg powder for concentrate for solution for infusion
Slovak: 5 mg prášok na infúzny koncentrát.
English: In monotherapy studies, clinically relevant serious adverse reactions also included infusion related reactions (2.5%), thrombocytopenia (21.7%), and neutropenia (34.3%).
Slovak: V štúdiách s monoterapiou patrili medzi klinicky významné závažné nežiaduce reakcie aj reakcie súvisiace s infúziou (2,5
English: o. Abdominal pain includes the following reported PTs: Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal discomfort, and Abdominal tenderness.
Slovak: Bolesť brucha zahŕňa nasledujúce hlásené PT: bolesť brucha, bolesť v hypogastriu, bolesť v epigastriu, brušný diskomfort a citlivosť brucha.
English: • Itchy skin
Slovak: • zápal úst,
English: MYLOTARG 5 mg powder for concentrate for solution for infusion gemtuzumab ozogamicin
Slovak: 5 mg prášok na infúzny koncentrát gemtuzumab ozogamicín bezpečnosti.
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 34 and 35 days, respectively.
Slovak: Medián času obnovy počtu trombocytov na hodnotu 50 000/mm 3 bol 34 dní a na hodnotu 100 000/mm 3 35 dní.
English: • have or ever had liver problems: MYLOTARG may cause, during or after treatment, a potentially life-threatening condition called hepatic venoocclusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots which may include fluid retention, rapid weight gain, increased liver size (which may be painful), and ascites (excessive accumulation of fluid in the abdominal cavity).
Slovak: • máte alebo ste niekedy mali problémy s pečene, pri ktorom sa poškodia krvné cievy v môže zahŕňať zadržiavanie môže byť bolestivá) a ascit