FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the incidence rate of ADA development after MYLOTARG treatment was < 1% across the 4 clinical studies with ADA data.
Slovenian: Na splošno je bila stopnja pojavnosti ADA po zdravljenju z zdravilom MYLOTARG < 1 % v vseh 4 kliničnih študijah s podatki o ADA.
English: • Reduced number of white blood cells which may result in general weakness and a tendency to develop infections
Slovenian: • zmanjšanje števila belih krvnih celic, kar lahko povzroči splošno oslabelost in nagnjenost k razvoju okužb
English: No dose adjustment is required in elderly patients (≥ 65 years) (see section 5.2).
Slovenian: Prilagajanje odmerka pri starejših bolnikih (≥ 65 let) ni potrebno (glejte poglavje 5.2).
English: • Calculate the dose (mg) of MYLOTARG required.
Slovenian: • Izračunajte odmerek (mg) zdravila MYLOTARG, ki ga potrebujete.
English: Other severe or life-threatening non-haematologic toxicities
Slovenian: Druge hude ali življenjsko ogrožajoče nehematološke toksičnosti
English: Some of the side effects could be serious and may occur during or after treatment with MYLOTARG.
Slovenian: Nekateri neželeni učinki so lahko resni in se lahko pojavijo med zdravljenjem z zdravilom MYLOTARG ali po njem.
English: MYLOTARG should be administered under the supervision of a physician experienced in the use of anticancer medicinal products and in an environment where full resuscitation facilities are immediately available.
Slovenian: Zdravilo MYLOTARG je treba uporabljati pod nadzorom zdravnika, ki ima izkušnje z uporabo zdravil za zdravljenje rakavih obolenj, in v okolju, kjer je takoj na voljo vsa oprema za reanimacijo.
English: Previously untreated AML
Slovenian: Predhodno nezdravljena AML
English: The ALFA-0701 trial was not designed to prospectively evaluate the benefit of MYLOTARG in subgroups; analysis are presented for descriptive purposes only.
Slovenian: Namen preskušanja ALFA-0701 ni bil prospektivno oceniti koristi zdravila MYLOTARG v podskupinah; analize so predstavljene samo za namen predstavitve.
English: EFS and OS analysed by cytogenetic risk classification and cytogenetic/molecular risk classification are presented in Table 9 and Table 10 below.
Slovenian: EFS in OS, ki so jih analizirali v skladu s klasifikacijo citogenetskega tveganja in klasifikacijo citogenetskega/molekularnega tveganja, so predstavljeni v preglednici 9 in preglednici 10 spodaj.
English: Effects on male rat reproductive organs were partially reversible or not reversible (see section 4.6).
Slovenian: Vplivi na reprodukcijske organe pri samcih podgan so bili delno reverzibilni ali niso bili reverzibilni (glejte poglavje 4.6).
English: c. 2-sided p-value from the log-rank test.
Slovenian: 2-stranska vrednost p po testu log-rank.
English: ALFA-0701 study of previously untreated patients with de novo AML
Slovenian: Študija ALFA-0701 predhodno nezdravljenih bolnikov z AML de novo
English: Signs and symptoms of infusion related reactions may include fever and chills, and less frequently hypotension, tachycardia, and respiratory symptoms that may occur during the first 24 hours after administration.
Slovenian: Znaki in simptomi z infuzijo povezanih reakcij lahko vključujejo vročino in mrzlico, manj pogosto pa hipotenzijo, tahikardijo in respiratorne simptome, ki se lahko pojavijo v prvih 24 urah po uporabi zdravila.
English: For patients who develop abnormal liver tests, more frequent monitoring of liver tests and clinical signs and symptoms of hepatotoxicity is recommended.
Slovenian: Pri bolnikih, pri katerih pride do nenormalnih vrednosti jetrnih testov, je priporočljivo pogostejše spremljanje jetrnih testov in kliničnih znakov ter simptomov hepatotoksičnosti.
English: • During the infusion, the intravenous bag or syringes needs to be protected from light using a light (including ultraviolet light) blocking cover.
Slovenian: • Med infundiranjem je treba intravensko vrečo ali brizge zaščititi pred svetlobo s pregrinjalom, ki ne prepušča svetlobe (vključno z ultravijolično svetlobo).
English: Total bilirubin > 2 × ULN and AST and/or ALT > 2.5 × ULN
Slovenian: celokupni bilirubin > 2 × ZMN in AST in/ali ALT > 2,5 × ZMN
English: • MYLOTARG contains no bacteriostatic preservatives.
Slovenian: • Zdravilo MYLOTARG ne vsebuje bakteriostatičnih konzervansov.
English: The adverse reactions are presented by system organ class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so predstavljeni po organskih sistemih in pogostnosti pojavljanja skladno z naslednjim dogovorom: zelo pogosti ( 1/10); pogosti ( 1/100 do < 1/10); občasni ( 1/1.000 do < 1/100); redki ( 1/10.000 do < 1/1.000), zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Withdraw this amount from the vial using a syringe.
Slovenian: Z brizgo izvlecite to količino iz viale.
English: One VOD event occurred more than 28 days of last dose of gemtuzumab ozogamicin; with 1 of these events occurring a few days after having started an HSCT conditioning regimen.
Slovenian: En primer VOD se je pojavil več kot 28 dni po zadnjem odmerku gemtuzumab ozogamicina; 1 od teh dogodkov se je pojavil nekaj dni po začetku pripravljalnega režima za PKMC.
English: This is consistent with the known induction of DNA breaks by calicheamicin and other enediyne antitumour antibiotics.
Slovenian: To je skladno z znano indukcijo pretrganja DNK s kaliheamicinom in drugimi endiinskimi protitumorskimi antibiotiki.
English: Effect on UGT substrates
Slovenian: Učinek na substrate UGT
English: When male rats were mated again after a 9-week non-dosing period, effects on sperm and fertility were worse but there was partial recovery of the lower spermatogonia and spermatocytes in the testes.
Slovenian: Ko so se podgane po 9-tedenskem obdobju brez odmerjanja ponovno parile, so bili učinki na spermo in plodnost slabši, vendar pa je prišlo do delnega izboljšanja zmanjšanega števila spermatogonijev in spermatocitov v testisih.
English: • infection: have or think you have, an infection, develop chills or shivering, or feel warm, or have fever.
Slovenian: • okužba: imate ali mislite, da imate okužbo, občutite mrzlico ali drgetanje, vam je toplo ali imate vročino.
English: A monoclonal antibody is a protein which recognises certain cancer cells.
Slovenian: Monoklonsko protitelo je beljakovina, ki prepozna določene rakave celice.
English: Relapsed or refractory AML
Slovenian: Recidivna ali refraktarna AML
English: In patients, the total volume of distribution of hP67.6 antibody (sum of V1 [10 L] and V2 [15 L]) was found to be approximately 25 L.
Slovenian: Pri bolnikih so ugotovili, da je celokupni volumen porazdelitve protitelesa hP67.6 (seštevek vrednosti V1 [10 l] in V2 [15 l]) približno 25 l.
English: Consolidation Course 2a,b
Slovenian: 2. konsolidacijski cikel a,b
English: What you need to know before you are given MYLOTARG
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo MYLOTARG
English: Ask your doctor how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte z zdravnikom.
English: • Changes in the levels of different enzymes in the blood (may show in your blood tests)
Slovenian: • spremembe ravni raznih encimov v krvi (se lahko pokaže pri krvnih preiskavah)
English: • Your doctor will do blood tests during the treatment to check for side effects and for response to treatment.
Slovenian: • Zdravnik bo med zdravljenjem opravljal preiskave krvi in vas tako preverjal glede pojava neželenih učinkov in vašega odziva na zdravljenje.
English: Patients should be monitored until signs and symptoms completely resolve.
Slovenian: Bolnike je treba spremljati, dokler znaki in simptomi ne izzvenijo popolnoma.
English: In clinical studies, TLS was reported (see section 4.8).
Slovenian: V kliničnih študijah so poročali o TLS (glejte poglavje 4.8).
English: Infections and bleeding/haemorrhagic reactions were reported, some of which were life-threatening or fatal.
Slovenian: Poročali so o okužbah in krvavitvah/hemoragičnih reakcijah; nekateri od teh primerov so bili življenjsko ogrožajoči ali smrtni.
English: Tables 3 and 4 show the dose modification guidelines for haematological and non-haematological toxicities, respectively.
Slovenian: Preglednici 3 in 4 prikazujeta smernice za prilagajanje odmerkov za hematološko oziroma nehematološko toksičnost.
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).
Slovenian: Tekom zdravljenja je število bolnikov s perzistentno trombocitopenijo ostalo podobno (8 bolnikov [7,4 %] v indukcijski fazi, 8 bolnikov [8,5 %] v 1. konsolidacijski fazi in 10 bolnikov [13,2 %] v 2. konsolidacijski fazi).
English: Interrupt the infusion and institute appropriate medical management based on the severity of symptoms.
Slovenian: Z infuzijo povezane reakcije Infundiranje prekinite in zagotovite ustrezno medicinsko obravnavo glede na resnost simptomov.
English: The safety and efficacy of MYLOTARG in patients less than 15 years of age has not been established.
Slovenian: Varnost in učinkovitost zdravila MYLOTARG pri bolnikih, mlajših od 15 let, nista bili dokazani.
English: • Signs of an enlarged liver (hepatomegaly), such as an enlarged belly
Slovenian: • znaki zvečanih jeter (hepatomegalija), kot je povečan trebuh
English: Patients in the Phase 2 trials did not develop antidrug antibodies (ADAs) and only 2 patients in a Phase 1 trial developed antibodies against the calicheamicin-linker complex, 1 of whom had reduced hP67.6 plasma concentrations.
Slovenian: V preskušanjih 2. faze bolniki niso razvili protiteles proti zdravilu (ADA - Antidrug Antibody), v preskušanju 1. faze pa sta le 2 bolnika razvila protitelesa proti kompleksu kaliheamicin-povezovalec, pri čemer je 1 od njiju imel znižane koncentracije hP67.6 v plazmi.
English: See section 5.2 for available data from in vitro studies.
Slovenian: Za razpoložljive podatke iz študij in vitro glejte poglavje 5.2.
English: Hepatotoxicity, including hepatic VOD/SOS
Slovenian: Hepatotoksičnost, vključno z VOD jeter/SOS
English: Total dosing of MYLOTARG ranged from 1.8 mg/m2 to 9 mg/m2.
Slovenian: Skupni odmerek zdravila MYLOTARG je bil v razponu od 1,8 mg/m2 do 9 mg/m2.
English: f. Overall response difference; CI based on Santner and Snell method.
Slovenian: Razlika v celokupnem odzivu; IZ na podlagi Santner-Snellove metode.
English: Safety results from a systematic literature review in paediatric patients with relapsed or refractory AML who received MYLOTARG
Slovenian: Rezultati varnosti iz sistematičnega pregleda literature pri pediatričnih bolnikih z recidivno ali refraktarno AML, ki so prejemali zdravilo MYLOTARG
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.
Slovenian: Rezultati varnosti, ki so jih opazili pri sistematičnem pregledu literature o študijah, v katerih so ocenjevali zdravilo MYLOTARG pri pediatričnih bolnikih (glejte poglavje 5.1), so predstavljeni v preglednici 7.
English: Consolidation
Slovenian: Konsolidacija
English: Hepatotoxicity, including hepatic venoocclusive disease/sinusoidal obstruction syndrome (VOD/SOS)
Slovenian: Hepatotoksičnost, vključno z venookluzivno boleznijo jeter/sindromom obstrukcije sinusoidov (VOD/SOS)
English: Proportions were transformed using Freeman-Tukey double arcsine transformation prior to combining studies, and the estimated combined rate was back-transformed using the harmonic mean of study sample sizes.
Slovenian: Deleže so pretvorili s Freeman-Tukeyevo arkus sinus korensko transformacijo pred združevanjem študij, ocenjeni združeni delež pa so pretvorili nazaj s harmonizirano srednjo vrednostjo velikosti vzorca v študijah.
English: b. For patients experiencing a complete remission (CR) following induction.
Slovenian: Pri bolnikih, pri katerih je po indukciji prišlo do popolne remisije (CR).
English: What MYLOTARG is and what it is used for
Slovenian: Kaj je zdravilo MYLOTARG in za kaj ga uporabljamo
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.
Slovenian: Skupno je bila mediana starost bolnikov 62 let (razpon od 50 do 70 let), večina bolnikov (87,8 %) pa je imela izhodiščno stanje zmogljivosti (PS - Performance Status), ocenjeno po lestvici ECOG (Eastern Cooperative Oncology Group), od 0 do 1.
English: • Excessive accumulation of fluid in the abdomen/stomach
Slovenian: • čezmerno kopičenje tekočine v trebuhu/želodcu
English: Both men and women should seek advice on fertility preservation before treatment.
Slovenian: Moški in ženske se morajo pred zdravljenjem posvetovati glede ohranjanja plodnosti.
English: MYLOTARG was given as monotherapy in 47.1%, part of a combination in 23.5%, and in both settings in 29.4% of the studies.
Slovenian: Zdravilo MYLOTARG so dajali kot monoterapijo v 47,1 %, kot del kombiniranega zdravljenja v 23,5 % in v obeh oblikah v 29,4 % študij.
English: MYLOTARG is intended for the treatment of AML for patients age 15 years and above who have not tried other treatments.
Slovenian: Zdravilo MYLOTARG je namenjeno za zdravljenje AML pri bolnikih, starih 15 let in več, ki predhodno niso prejeli drugih zdravljenj.
English: Infusion related reactions (including anaphylaxis)
Slovenian: Reakcije, povezane z infuzijo (vključno z anafilaksijo)
English: • Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)
Slovenian: • rumenkasto obarvanje kože ali beločnic zaradi težav z jetri ali krvjo (zlatenica)
English: Symptoms may also include feeling sick (nausea) and/or vomiting.
Slovenian: Simptomi lahko vključujejo tudi slabost s siljenjem na bruhanje (navzea) in/ali bruhanje.
English: Overall, 59.0% and 65.3% of patients had documented favourable/intermediate-risk disease by the National Comprehensive Cancer Network (NCCN) and European LeukaemiaNet (ELN) 2010 risk classifications, respectively.
Slovenian: Skupno je imelo 59,0 % oziroma 65,3 % bolnikov dokumentirano bolezen z ugodnim tveganjem po klasifikaciji tveganj združenja NCCN (National Comprehensive Cancer Network) oziroma zmernim tveganjem po klasifikaciji tveganj združenja ELN (European LeukaemiaNet) iz leta 2010.
English: Both of these patients experienced VOD more than 28 days after the last dose of gemtuzumab ozogamicin.
Slovenian: Pri obeh bolnikih se je VOD pojavila več kot 28 dni po zadnjem odmerku gemtuzumab ozogamicina.
English: If you need treatment with MYLOTARG, you must stop breast-feeding during treatment and for at least 1 month after treatment.
Slovenian: Če potrebujete zdravljenje z zdravilom MYLOTARG, med zdravljenjem in še najmanj 1 mesec po zdravljenju ne smete dojiti.
English: The relevance of the irreversible animal findings to humans is uncertain.
Slovenian: Pomen ireverzibilnih ugotovitev pri živalih za ljudi je negotov.
English: Patients in either arm who did not receive the second course of induction therapy and did not achieve a CR after induction could receive a salvage course comprised of idarubicin, AraC, and granulocyte colonystimulating factor (G-CSF).
Slovenian: Bolniki v obeh skupinah, ki niso prejeli drugega cikla indukcijskega zdravljenja in po indukciji niso dosegli CR, so lahko prejeli cikel rešilnega zdravljenja, ki je obsegal idarubicin, citarabin in granulocitne kolonije stimulirajoči faktor (G-CSF - Granulocyte Colony-Stimulating Factor).
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.
Slovenian: O VOD so poročali tudi pri 2 bolnikih, ki sta zdravilo MYLOTARG prejemala kot nadaljnje zdravljenje po ponovitvi AML po zdravljenju s kemoterapijo v kontrolni skupini študije kombiniranega zdravljenja.
English: One of these patients experienced VOD 25 days after the subsequent HSCT.
Slovenian: Pri enem od teh bolnikov se je VOD pojavila 25 dni po kasnejši PKMC.
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.
Slovenian: • Preden boste prejeli zdravilo MYLOTARG, boste prejeli nekaj zdravil, ki pomagajo zmanjšati simptome z infuzijo povezane reakcije, kot sta vročina in mrzlica, ki se pojavijo med infundiranjem zdravila MYLOTARG ali kmalu po njem.
English: Do not use this medicine if you notice any particulate matter or discolouration prior to administration.
Slovenian: Tega zdravila ne uporabite, če pred uporabo opazite vidne delce ali obarvanost.
English: It is supplied as white to off-white cake or powder.
Slovenian: Na voljo je kot bela do belkasta pogača ali prašek.
English: Contact your doctor immediately if you or your partner becomes pregnant while taking this medicine.
Slovenian: Nemudoma obvestite zdravnika, če med zdravljenjem s tem zdravilom vi ali vaša partnerka zanosite.
English: MYLOTARG is for intravenous use and must be reconstituted and diluted before administration (see section 6.6).
Slovenian: Zdravilo MYLOTARG je za intravensko uporabo in ga je treba pred uporabo rekonstituirati in razredčiti (glejte poglavje 6.6).
English: Gemtuzumab is a humanised immunoglobulin class G subtype 4 (IgG4) antibody which specifically recognises human CD33.
Slovenian: Gemtuzumab je humanizirano protitelo, imunoglobulin razreda G podtipa 4 (IgG4), ki specifično prepoznava humani CD33.
English: The activity (cytotoxicity) of the resultant metabolites is expected to be significantly attenuated.
Slovenian: Aktivnost (citotoksičnost) nastalih presnovkov je pričakovano znatno oslabljena.
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.
Slovenian: Celoten varnostni profil zdravila MYLOTARG temelji na podatkih bolnikov z akutno mieloično levkemijo iz študije kombiniranega zdravljenja ALFA-0701, študijah monoterapije in izkušnjah v obdobju trženja zdravila.
English: • Following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, MYLOTARG solution should be infused immediately.
Slovenian: • Po redčenju z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje je treba raztopino zdravila MYLOTARG infundirati takoj.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC05
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC05
English: 4 studies; N per study (range) 12-84; 42.2%
Slovenian: 4 študije; n na študijo (razpon) 12-84; 42,2 %
English: Do not mix MYLOTARG with, or administer as an infusion with, other medicinal products.
Slovenian: Zdravila MYLOTARG ne smete mešati ali ga dajati kot infuzijo z drugimi zdravili.
English: • Interstitial pneumonia (inflammation of the lungs causing coughing and difficulty breathing)
Slovenian: • intersticijska pljučnica (vnetje pljuč, ki povzroča kašelj in težko dihanje)
English: Effect of other medicinal products on gemtuzumab ozogamicin
Slovenian: Učinek drugih zdravil na gemtuzumab ozogamicin
English: Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase; SOS=sinusoidal obstruction syndrome; ULN=upper limit of normal; VOD=venoocclusive disease.
Slovenian: Okrajšave: ALT = alanin-aminotransferaza; AST = aspartat-aminotransferaza; SOS = sindrom obstrukcije sinusoidov; ZMN = zgornja meja normale; VOD = venookluzivna bolezen.
English: Probability (%) calculated by the product-limit method; CI calculated from the log log transformation of survival probability using a normal approximation and the Greenwood formula.
Slovenian: Verjetnost (%), izračunana po Kaplan-Meierjevi metodi; IZ, izračunan iz transformacije log-log verjetnosti preživetja z uporabo normalne aproksimacije in Greenwoodove formule.
English: Your doctor may do blood tests and find abnormalities in liver blood tests, which might be signs of a potentially life-threatening condition called venoocclusive liver disease.
Slovenian: Zdravnik bo morda opravil krvne preiskave, ki lahko pokažejo nenormalno delovanje jeter, kar so lahko znaki potencialno življenjsko ogrožajoče bolezni, ki se imenuje venookluzivna bolezen jeter.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1277/001
Slovenian: EU/1/18/1277/001
English: 5 studies; N per study (range) 12-30; 28.4%
Slovenian: 5 študij; n na študijo (razpon) 12-30; 28,4 %
English: • Reduced number of blood platelets (cells that help blood to clot)
Slovenian: • zmanjšanje števila krvnih ploščic (celic, ki pomagajo pri strjevanju krvi)
English: In patients who experience VOD/SOS, MYLOTARG should be discontinued and patients treated according to standard medical practice.
Slovenian: Pri bolnikih, pri katerih pride do VOD/SOS, je treba zdravljenje z zdravilom MYLOTARG prekiniti in te bolnike zdraviti v skladu z običajno medicinsko prakso.
English: • The active substance is gemtuzumab ozogamicin.
Slovenian: • Učinkovina je gemtuzumab ozogamicin.
English: Additional findings included effects on the testes, epididymides and mammary gland as well as fertility.
Slovenian: Dodatno so ugotovili učinke na testise, epididimis in mlečno žlezo ter plodnost.
English: • Infusion reactions
Slovenian: • Reakcije na infuzijo
English: Tumour lysis syndrome (TLS)
Slovenian: Sindrom tumorske lize (TLS - Tumour Lysis Syndrome)
English: Other medicines and MYLOTARG
Slovenian: Druga zdravila in zdravilo MYLOTARG
English: • High blood sugar
Slovenian: • visoka raven sladkorja v krvi
English: Persistent thrombocytopenia (Platelets < 100,000/mm3 at the planned start date of the consolidation course)
Slovenian: Prilagoditve odmerkov perzistentna trombocitopenija (število trombocitov < 100.000/mm na načrtovani datum začetka konsolidacijskega cikla)
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.
Slovenian: Ob upoštevanju, da del protitelesa hP67.6 povzroči tarčno selektivnost na intaktni molekuli in da o odmerkih gemtuzumab ozogamicina poročajo v miligramih beljakovine (hP67.6), so rezultati koncentracije hP67.6 navedeni kot primarno farmakokinetično merilo.
English: • Reduced number of red blood cells (anaemia) which may result in fatigue and shortness of breath
Slovenian: • zmanjšanje števila rdečih krvnih celic (slabokrvnost), kar lahko povzroči utrujenost in kratko sapo
English: CD33 expression on AML blasts by flow cytometry harmonised from local laboratory results was determined in 194/271 (71.6%) patients overall.
Slovenian: Izražanje CD33 na blastih AML so ugotavljali s pretočno citometrijo, usklajeno z rezultati lokalnega laboratorija, pri skupno 194/271 bolnikov (71,6 %).
English: Reconstituted and diluted solution: Following reconstitution and dilution, the solution should be protected from light and should be used immediately.
Slovenian: Rekonstituirana in razredčena raztopina: Po rekonstituciji in redčenju je treba raztopino zaščititi pred svetlobo in jo uporabiti takoj.
English: Gemtuzumab ozogamicin is a CD33-targeted ADC.
Slovenian: Gemtuzumab ozogamicin je ADC, usmerjen proti CD33.
English: MYLOTARG should be used only in patients eligible to receive intensive induction chemotherapy.
Slovenian: Zdravilo MYLOTARG se sme uporabljati samo pri bolnikih, ki so primerni za intenzivno indukcijsko kemoterapijo.