FrancophonIA/ELRC3.0 huggingface dataset:
English: A systematic literature review of studies was conducted to evaluate MYLOTARG in paediatric patients with relapsed or refractory AML, which included 454 patients receiving MYLOTARG either as a monotherapy (single or fractionated dosing) or combination therapy from 16 published papers plus the US Expanded Access Study (see section 4.8).
Slovenian: Za oceno zdravila MYLOTARG pri pediatričnih bolnikih z recidivno ali refraktarno AML so opravili sistematični pregled literature o študijah; v pregled so zajeli 454 bolnikov, ki so prejemali zdravilo MYLOTARG bodisi kot monoterapijo (enkratno ali frakcionirano odmerjanje) bodisi kot kombinirano zdravljenje, iz 16 objavljenih člankov in študije razširjenega dostopa v ZDA (glejte poglavje 4.8).
English: Overall response % [95% CI]e CR
Slovenian: celokupni odziv v % [95 % IZ] CR
English: • anaemia: have headaches, feel tired, experience dizziness, or look pale .
Slovenian: • slabokrvnost: imate glavobole, ste utrujeni, se vam pojavi omotica ali ste videti bledi.
English: MYLOTARG is light sensitive and should be protected from ultraviolet light during reconstitution, dilution and administration.
Slovenian: Zdravilo MYLOTARG je občutljivo na svetlobo in ga je treba med rekonstitucijo, redčenjem in uporabo zaščititi pred ultravijolično svetlobo.
English: MYLOTARG is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see sections 4.4 and 5.1).
Slovenian: Zdravilo MYLOTARG je indicirano za kombinirano zdravljenje z daunorubicinom in citarabinom za zdravljenje bolnikov, starih 15 let in več, s predhodno nezdravljeno, de novo CD33-pozitivno akutno mieloično levkemijo (AML), razen tistih z akutno promielocitno levkemijo (APL) (glejte poglavji 4.4 in 5.1).
English: • Inflammation of the urinary bladder resulting in bleeding from the bladder
Slovenian: • vnetje sečnega mehurja, ki povzroči krvavitev iz mehurja
English: Because of the potential for adverse reactions in breast-fed children, women should not breast-feed during treatment with MYLOTARG and for at least 1 month after the final dose (see section 5.3).
Slovenian: Zaradi možnosti za neželene učinke pri dojenih otrocih ženske med zdravljenjem z zdravilom MYLOTARG in vsaj 1 mesec po zadnjem odmerku ne smejo dojiti (glejte poglavje 5.3).
English: • bleeding: have unusual bleeding, bleeding from your gums, bruising easily or getting nose bleeds on a regular basis.
Slovenian: • krvavitev: se vam pojavi nenavadna krvavitev, vam krvavijo dlesni, se vam hitro pojavijo modrice ali pogosto krvavite iz nosu.
English: • Inflammation of the bowel in association with low white blood cell counts
Slovenian: • vnetje črevesja, povezano z zmanjšanim številom belih krvnih celic
English: q. Transaminases increased includes the following reported PTs: Transaminases increased, Hepatocellular injury, Alanine aminotransferase increased, Aspartate aminotransferase increased, and Hepatic enzyme increased.
Slovenian: Zvečanje vrednosti transaminaz vključuje naslednje PT, o katerih so poročali: zvečanje vrednosti transaminaz, hepatocelularna poškodba, zvečanje vrednosti alanin-aminotransferaze, zvečanje vrednosti aspartat-aminotransferaze in zvečanje vrednosti jetrnih encimov.
English: Selected** adverse reactions in patients who received MYLOTARG in combination therapy study (ALFA-0701)
Slovenian: Izbrani neželeni učinki pri bolnikih, ki so prejemali zdravilo MYLOTARG v študiji kombiniranega zdravljenja (ALFA-0701)
English: Formal carcinogenicity studies have not been conducted with gemtuzumab ozogamicin.
Slovenian: Formalnih študij kancerogenosti z gemtuzumab ozogamicinom niso izvedli.
English: • Abnormalities in liver blood tests (which can be indicators of liver injury)
Slovenian: • nenormalni izvidi krvnih preiskav delovanja jeter (ki so lahko pokazatelji poškodbe jeter)
English: The most common adverse reactions (> 30%) in the combination therapy study were haemorrhage and infection.
Slovenian: Najpogostejša neželena učinka (> 30 %) v študiji kombiniranega zdravljenja sta bila krvavitev in okužba.
English: Store the vial in the original carton to protect from light.
Slovenian: Vialo shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
English: Delay treatment with MYLOTARG until recovery to a severity of no more than mild.
Slovenian: Odložite zdravljenje z zdravilom MYLOTARG, dokler ne pride do izboljšanja toksičnosti do stopnje, ki ni večja od blage.
English: Seek advice regarding fertility preservation before treatment.
Slovenian: Pred zdravljenjem se posvetujte glede ohranjanja plodnosti.
English: Dose modifications for haematological toxicities Haematological toxicities
Slovenian: Prilagoditve odmerkov za hematološke toksičnosti Hematološke toksičnosti
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide had a low potential to inhibit the activities of P-gp, breast cancer resistance protein (BCRP), bile salt export pump (BSEP), multidrug resistance associated protein (MRP) 2, multidrug and toxin extrusion protein (MATE)1 and MATE2K, organic anion transporter (OAT)1 and OAT3, organic cation transporter (OCT)1 and OCT2, and organic anion transporting polypeptide (OATP)1B1 and OATP1B3 at clinically relevant concentrations.
Slovenian: In vitro je imel N-acetil-gama-kaliheamicin dimetilhidrazid v klinično pomembnih koncentracijah nizek potencial za zaviranje aktivnosti P-gp, beljakovine odpornosti pri raku dojk (BCRP - Breast Cancer Resistance Protein), črpalke žolčnih soli (BSEP - Bile Salt Export Pump), beljakovine za odpornost na številna zdravila (MRP - Multidrug Resistance-Associated Protein) 2, beljakovine za ekstruzijo več zdravil in toksinov (MATE - Multidrug and Toxin Extrusion Protein)1 in MATE2K, prenašalca organskih anionov (OAT)1 in OAT3, prenašalca organskih kationov (OCT)1 in OCT2 ter polipeptidnega prenašalca organskih anionov (OATP)1B1 in OATP1B3.
English: Abbreviations: C=cytarabine; D=daunorubicin; GO=gemtuzumab ozogamicin; mITT=modified intent-to-treat.
Slovenian: Okrajšave: C = citarabin; D = daunorubicin; GO = gemtuzumab ozogamicin; mITT = modificirana populacija, ki so jo nameravali zdraviti.
English: Although the total dose of the fractionated dosing regimen is half of that of the original dosing regimen (9 versus 18 mg/m2), the predicted total AUC of hP67.6 over the course of treatment is 25%, and Cmax is 24%, of the values for original 9 mg/m2 dosing regimen, since the PK is nonlinear.
Slovenian: Čeprav celokupni odmerek režima frakcioniranega odmerjanja predstavlja polovico prvotnega režima odmerjanja (9 mg/m2 v primerjavi z 18 mg/m2), je zaradi nelinearne farmakokinetike predvidena celokupna vrednost AUC za hP67.6 v obdobju zdravljenja 25 %, vrednost Cmax pa 24 % vrednosti pri prvotnem režimu odmerjanja 9 mg/m2.
English: Overall, 29 (5.5%) of patients in the MYLOTARG arm and 15 (2.8%) patients in the comparator arm died during remission.
Slovenian: Med remisijo je umrlo skupno 29 (5,5 %) bolnikov v skupini, ki je prejemala zdravilo MYLOTARG, in 15 (2,8 %) bolnikov v primerjalni skupini.
English: The antibody portion binds specifically to the CD33 antigen, a sialic acid-dependent adhesion protein found on the surface of myeloid leukaemic blasts and immature normal cells of myelomonocytic lineage, but not on normal haematopoietic stem cells.
Slovenian: Del protitelesa se specifično veže na CD33, od sialne kisline odvisno adhezijsko beljakovino, ki jo najdemo na površini mieloičnih levkemičnih blastov in nezrelih normalnih celic mielomonocitne linije, vendar ne na normalnih krvotvornih matičnih celicah.
English: Complications associated with neutropenia and thrombocytopenia may include infections and bleeding/haemorrhagic reactions respectively.
Slovenian: Z nevtropenijo oziroma trombocitopenijo povezani zapleti lahko vključujejo okužbe oziroma krvavitve/hemoragične reakcije.
English: Based on a population PK analysis, age, race, and gender did not significantly affect gemtuzumab ozogamicin disposition.
Slovenian: Glede na populacijsko farmakokinetično analizo starost, rasa in spol niso pomembno vplivali na odstranjevanje gemtuzumab ozogamicina.
English: Reconstitute each 5 mg vial with 5 mL of water for injections to obtain a single-use solution of 1 mg/mL of gemtuzumab ozogamicin.
Slovenian: Eno 5 mg vialo rekonstituirajte s 5 ml vode za injekcije, da dobite raztopino gemtuzumab ozogamicina 1 mg/ml za enkratno uporabo.
English: • Liver problems
Slovenian: • Težave z jetri
English: Therefore, coadministration of gemtuzumab ozogamicin with inhibitors or inducers of cytochrome P450 (CYP) or uridine diphosphate glucuronosyltransferase (UGT) drug metabolising enzymes are unlikely to alter exposure to N-acetyl gamma calicheamicin dimethyl hydrazide.
Slovenian: Zato ni verjetno, da bi sočasna uporaba gemtuzumab ozogamicina z zaviralci ali induktorji citokroma P450 (CYP) ali encimi uridin-difosfo-glukuronoziltransferaz (UGT) za presnovo zdravil, spremenila izpostavljenost N-acetil-gama-kaliheamicin dimetilhidrazidu.
English: • Signs of an infusion reaction, such as a rash, shortness of breath, difficulty breathing, a tight chest,
Slovenian: • znaki reakcije na infuzijo, kot so izpuščaj, kratka sapa, težko dihanje, stiskanje v prsnem košu,
English: Non-clinical data suggest that the anticancer activity of gemtuzumab ozogamicin is due to the binding of the ADC to CD33-expressing tumour cells, followed by internalisation of the ADC-CD33 complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker.
Slovenian: Neklinični podatki kažejo, da gemtuzumab ozogamicin deluje proti rakavim obolenjem zaradi vezave ADC na tumorske celice z izraženim CD33, čemur sledi internalizacija kompleksa ADC-CD33 in znotrajcelično sproščanje N-acetil-gama-kaliheamicin dimetilhidrazida preko hidrolitske cepitve povezovalca.
English: • A doctor or nurse will give you MYLOTARG through a drip in your vein (intravenous infusion [IV]) gradually over 2 hours.
Slovenian: • Zdravnik ali medicinska sestra vam bosta postopoma dajala zdravilo MYLOTARG kapalno v veno (intravenska infuzija [i.v.
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).
Slovenian: • imate ali ste kdaj imeli težave z jetri: zdravilo MYLOTARG lahko med zdravljenjem ali po njem povzroči potencialno življenjsko ogrožajoče stanje, imenovano venookluzivna bolezen jeter, pri katerem krvni strdki poškodujejo in zamašijo žile v jetrih, kar lahko vključuje zastajanje tekočine v telesu, hitro povečanje telesne mase, povečanje jeter (ki je lahko boleče) in ascites (prekomerno kopičenje tekočine v trebušni votlini).
English: • Abnormal liver function
Slovenian: • nenormalno delovanje jeter
English: Nervous system effects have not been observed in animals after administration of MYLOTARG.
Slovenian: Učinkov na živčevje po uporabi zdravila MYLOTARG pri živalih niso ugotavljali.
English: • Feeling sick (nausea)
Slovenian: • občutek siljenja na bruhanje (navzea)
English: Women of childbearing potential should be advised to avoid becoming pregnant while receiving MYLOTARG.
Slovenian: Ženskam v rodni dobi je treba svetovati, naj se med zdravljenjem z zdravilom MYLOTARG izogibajo zanositvi.
English: Kaplan-Meier plot of event-free survival by investigator assessment from study ALFA-0701 (mITT population)
Slovenian: Kaplan-Meierjeva krivulja preživetja brez dogodkov po oceni raziskovalca iz študije ALFA-0701 (populacija mITT)
English: MYLOTARG is not for use in patients with a type of cancer called acute promyelocytic leukaemia (APL).
Slovenian: Zdravilo MYLOTARG ni primerno za uporabo pri bolnikih z določeno vrsto raka, ki se imenuje akutna promielocitna levkemija (APL).
English: Thus, the optimal dose of gemtuzumab ozogamicin for paediatric patients was not established (see section 4.2).
Slovenian: Zato pri pediatričnih bolnikih optimalnega odmerka gemtuzumab ozogamicina niso ugotovili (glejte poglavje 4.2).
English: In clinical studies infusion related reactions, including anaphylaxis were reported (see section 4.8).
Slovenian: V kliničnih študijah so poročali o reakcijah, povezanih z infuzijo, vključno z anafilaksijo (glejte poglavje 4.8).
English: • Your doctor may change your dose, interrupt, or completely stop treatment with MYLOTARG if you have certain side effects.
Slovenian: • Zdravnik lahko spremeni odmerek, prekine ali popolnoma ukine zdravljenje z zdravilom
English: The most frequent Grade 3 bleeding/haemorrhagic reactions were epistaxis (1.5%), haemoptysis (3.1%), and haematuria (2.3%).
Slovenian: Najpogostejše krvavitve/hemoragične reakcije stopnje 3 so bile epistaksa (1,5 %), hemoptiza (3,1 %) in hematurija (2,3 %).
English: In a male fertility study, effects on male reproduction included lower spermatogonia and spermatocytes, decreases in testicular spermatids and epididymal sperm, vacuolation of the nucleus in spermatids, and/or appearance of giant cells.
Slovenian: V študiji plodnostih pri samcih so učinki na reprodukcijske organe pri samcih vključevali manjše število spermatogonijev in spermatocitov, manjše število spermatid v testisih, zmanjšano količino sperme v epididimisu, vakuolizacijo jedra spermatid in/ali pojav celic velikank.
English: Routine clinical and laboratory surveillance testing during and after treatment is indicated.
Slovenian: Med zdravljenjem in po njem so indicirane rutinske klinične in laboratorijske preiskave za spremljanje bolnikov.
English: o Doses greater than or equal to 3.9 mg are to be diluted in a syringe or an IV bag in an appropriate volume of sodium chloride 9 mg/mL (0.9%) solution for injection to ensure a final concentration between 0.075 mg/mL to 0.234 mg/mL.
Slovenian: o Odmerke, večje ali enake 3,9 mg, je treba razredčiti v brizgi ali infuzijski vreči v ustrezni količini natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje, da zagotovite končno koncentracijo med 0,075 mg/ml in 0,234 mg/ml.
English: Based on a population PK analysis in 406 patients, the clearance of gemtuzumab ozogamicin in patients with mild renal impairment (creatinine clearance [CLcr] 60-89 mL/min; n=149) or moderate renal impairment (CLcr 30-59 mL/min; n=47), was similar to patients with normal renal function (CLcr ≥ 90 mL/min; n=209).
Slovenian: Glede na populacijsko farmakokinetično analizo pri 406 bolnikih je bil očistek gemtuzumab ozogamicina pri bolnikih z blago ledvično okvaro (očistek kreatinina [CLcr] 60-89 ml/min; n = 149) ali zmerno ledvično okvaro (CLcr 30-59 ml/min; n = 47) podoben kot pri bolnikih z normalnim delovanjem ledvic (CLcr ≥ 90 ml/min; n = 209).
English: The recommended dose of MYLOTARG is 3 mg/m2/dose (up to a maximum of one 5 mg vial) infused over a 2-hour period on Days 1, 4, and 7 in combination with DNR 60 mg/m2/day infused over 30 minutes on Day 1 to Day 3, and AraC 200 mg/m2/day by continuous infusion on Day 1 to Day 7.
Slovenian: Priporočeni odmerek zdravila MYLOTARG je 3 mg/m 2/odmerek (do največ ene 5 mg viale) v obliki 2-urne infuzije na 1., 4. in 7. dan v kombinaciji s 60 mg/m 2/dan daunorubicina v obliki 30-minutne infuzije od 1. do 3. dne in 200 mg/m 2/dan citarabina v obliki kontinuirane infuzije od 1. do 7. dne.
English: Unopened vial: Store in a refrigerator (2°C-8°C).
Slovenian: Neodprta viala: Shranjujte v hladilniku (2 °C - 8 °C).
English: t. Hepatic function abnormal includes the following reported PTs: Liver function test abnormal and Hepatic function abnormal.
Slovenian: Nenormalno delovanje jeter vključuje naslednja PT, o katerih so poročali: nenormalni izvidi testov jetrne funkcije in nenormalno delovanje jeter.
English: Store in the original carton to protect from light.
Slovenian: Shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
English: See Table 1 for dose recommendations for consolidation course.
Slovenian: Za priporočila glede odmerjanja pri konsolidacijskem ciklu glejte preglednico 1.
English: MYLOTARG contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose.
Slovenian: Zdravilo MYLOTARG vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni "brez natrija".
English: This substance is delivered to cancer cells by the monoclonal antibody.
Slovenian: To učinkovino v rakave celice dostavlja monoklonsko protitelo.
English: N-acetyl gamma calicheamicin is covalently attached to the antibody via an AcBut (4-(4-acetylphenoxy) butanoic acid) linker.
Slovenian: N-acetil-gama-kaliheamicin je na protitelo kovalentno vezan preko povezovalca AcBut (4-(4-acetilfenoksi)butanojska kislina).
English: • Inspect the reconstituted solution for particulates and discolouration.
Slovenian: • Rekonstituirano raztopino preglejte glede prisotnosti vidnih delcev in obarvanosti.
English: • Prior to reconstitution, allow the vial to reach room temperature (below 25°C) for approximately 5 minutes.
Slovenian: • Pred rekonstitucijo pustite vialo približno 5 minut, da se segreje na sobno temperaturo (do 25 °C).
English: In monotherapy studies, clinically relevant serious adverse reactions also included infusion related reactions (2.5%), thrombocytopenia (21.7%), and neutropenia (34.3%).
Slovenian: V študijah monoterapije so klinično pomembni resni neželeni učinki vključevali tudi z infuzijo povezane reakcije (2,5 %), trombocitopenijo (21,7 %) in nevtropenijo
English: Several single agent studies measured target (CD33) saturation post-MYLOTARG dose in patients with relapsed and refractory AML.
Slovenian: V številnih študijah monoterapije so merili ciljno nasičenost (CD33) po odmerku zdravila MYLOTARG pri bolnikih z recidivno in refraktarno AML.
English: Baseline characteristics were balanced between treatment arms with the exception of gender as a higher percentage of males were enrolled in the MYLOTARG arm (54.8%) than in the DA alone arm (44.1%).
Slovenian: Med zdravljenima skupinama so uravnotežili izhodiščne značilnosti, razen spola, saj so v skupino, ki je prejemala zdravilo MYLOTARG, vključili več moških (54,8 %) kot v skupino, ki je prejemala samo DA, (44,1 %).
English: For patients being treated with MYLOTARG in combination with daunorubicin and cytarabine for newly diagnosed de novo AML, when cytogenetics testing results become available it should be considered whether the potential benefit of continuing treatment with MYLOTARG outweighs the risks for the individual patient (see section 5.1).
Slovenian: Ko so na voljo izvidi citogenetske preiskave pri bolnikih, zdravljenih z zdravilom MYLOTARG v kombinaciji z daunorubicinom in citarabinom zaradi na novo diagnosticirane AML de novo, je treba razmisliti, ali morebitna korist nadaljevanja zdravljenja z zdravilom MYLOTARG odtehta tveganja za posameznega bolnika (glejte poglavje 5.1).
English: The incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, circulating gemtuzumab ozogamicin concentrations, sample handling, timing of sample collection, concomitant treatments and underlying disease.
Slovenian: Na pozitivnost preskusa za ugotavljanje prisotnosti protiteles lahko vpliva več dejavnikov, med drugim metodologija preskusa, koncentracija gemtuzumab ozogamicina v obtoku, ravnanje z vzorcem, čas odvzema vzorca, sočasno zdravljenje in osnovna bolezen.
English: Consider omitting scheduled dose if delayed more than 2 days between sequential infusions.
Slovenian: Če je med zaporednima infuzijama minilo več kot 2 dni, razmislite o izpustitvi načrtovanega odmerka.
English: a. Median estimated by Kaplan-Meier method; CI based on the Brookmeyer-Crowley method with log-log transformation.
Slovenian: Mediana ocena po Kaplan-Meierjevi metodi; IZ na podlagi Brookmeyer-Crowleyjeve metode s transformacijo log-log.
English: In total, 271 patients were randomised in this study with 135 to induction treatment of 3+7 DA plus fractionated 3 mg/m2 × 3 doses of MYLOTARG and 136 to 3+7 DA alone (see section 4.2).
Slovenian: Skupno so v študiji randomizirali 271 bolnikov, od katerih so 135 bolnikov vključili v indukcijsko zdravljenje s 3 + 7 DA plus 3 frakcioniranimi odmerki zdravila MYLOTARG po 3 mg/m 136 bolnikov pa so zdravili samo s 3 + 7 DA (glejte poglavje 4.2).
English: • allergic reaction: experience a high-pitched whistling sound during breathing (wheezing), difficult breathing, shortness of breath or cough with or without mucous, hives, itching, swelling, or feeling fever and chills (signs of an infusion related reaction) during or shortly after the MYLOTARG infusion.
Slovenian: • alergijska reakcija: če med dihanjem slišite visok, piskajoč zvok (piskajoče dihanje), težko dihate, ste zasopli (imate kratko sapo) ali kašljate s sluzjo ali brez nje, imate koprivnico, vas srbi koža, opazite otekanje ali imate vročino in mrzlico (znaka z infuzijo povezane reakcije) med infundiranjem zdravila MYLOTARG ali kmalu po njem.
English: The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic semisynthetic natural product.
Slovenian: Majhna molekula, N-acetil-gama-kaliheamicin, je citotoksična polsintezna učinkovina naravnega izvora.
English: Consider permanent discontinuation of treatment for severe or life-threatening infusion reactions (see section 4.4).
Slovenian: Pri hudih ali življenjsko ogrožajočih reakcijah na infuzijo razmislite o trajni prekinitvi zdravljenja (glejte poglavje 4.4).
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.
Slovenian: Zdravilo MYLOTARG vsebuje učinkovino gemtuzumab ozogamicin, tj. zdravilo za zdravljenje rakavih obolenj, ki je sestavljeno iz monoklonskega protitelesa, ki je povezano z učinkovino, namenjeno uničevanju rakavih celic.
English: • Liver venoocclusive disease (VOD), which includes signs of enlarged liver, pain in the upper right belly, yellowing of the skin and the whites of the eyes, accumulation of fluid in the abdomen, weight gain, abnormal liver blood tests
Slovenian: • venookluzivna bolezen jeter, ki vključuje znake povečanih jeter, bolečino v zgornjem desnem delu trebuha, rumenkasto obarvanje kože in beločnic, kopičenje tekočine v trebuhu, povečanje telesne mase, nenormalne izvide krvnih preiskav delovanja jeter
English: Fatal bleeding/haemorrhagic reactions were reported in 3 (2.3%) patients (cerebral haematoma, intracranial haematoma, and subdural haematoma).
Slovenian: O krvavitvah/hemoragičnih reakcijah s smrtnim izidom so poročali pri 3 bolnikih (2,3 %) (možganski hematom, intrakranialni hematom in subduralni hematom).
English: N per study (range)
Slovenian: število študij n na študijo (razpon)
English: In vitro studies demonstrated that N-acetyl gamma calicheamicin dimethyl hydrazide is extensively metabolised, primarily via nonenzymatic reduction of the disulphide moiety.
Slovenian: Študije in vitro so pokazale, da se N-acetil-gama-kaliheamicin dimetilhidrazid obsežno presnavlja, primarno preko neencimske redukcije disulfidne skupine.
English: a. Median estimated by Kaplan-Meier method; CI based on the Brookmeyer and Crowley Method with log-log transformation.
Slovenian: Mediana ocena po Kaplan-Meierjevi metodi; IZ na podlagi Brookmeyer-Crowleyjeve metode s transformacijo loglog.
English: The lowest dose with embryo-foetal effects correlated with 9.7 times the human clinical exposure after the third human dose of 3 mg/m2, based on AUC168 (see section 4.6).
Slovenian: Najmanjši odmerek z učinki na zarodek ali plod so opazili pri 9,7-kratniku klinične izpostavljenosti pri ljudeh po tretjem odmerku za človeka 3 mg/m2 na podlagi vrednosti AUC168 (glejte poglavje 4.6).