FrancophonIA/ELRC3.0 huggingface dataset:
English: Abbreviations: CR=complete remission; CRp=complete remission with incomplete platelet recovery; CI=confidence interval; EFS=event-free survival; mITT=modified intent-to-treat; n=number; N=number; NE= not estimable; OS=overall survival; RFS=relapse-free survival.
Croatian: Kratice: CR=potpuna remisija; CRp=potpuna remisija s nepotpunim oporavkom broja trombocita; CI=raspon pouzdanosti; EFS=preživljenje bez događaja; mITT=modificirana populacija planirana za liječenje; n=broj; N=broj; NP= nije procjenjivo; OS=ukupno preživljenje (engl. overall survival); RFS=preživljenje bez recidiva.
English: The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic semisynthetic natural product.
Croatian: Mala molekula Nacetil-gama-kalikeamicin citotoksičan je polusintetski prirodan produkt.
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).
Croatian: Najniža doza s embriofetalnim učincima korelirala je s izloženošću 9,7 puta većom od kliničke izloženosti ljudi nakon treće doze od 3 mg/m2 na temelju vrijednosti AUC168 (vidjeti dio 4.6).
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.
Croatian: Dodajte rekonstituiranu otopinu lijeka MYLOTARG u štrcaljku s 0,9 %-tnom (9 mg/ml) otopinom natrijevog klorida za injekciju do konačne koncentracije između 0,075 mg/ml i 0,234 mg/ml.
English: • Gently invert the infusion container to mix the diluted solution.
Croatian: • Pažljivo preokrenite spremnik za infuziju kako bi se razrijeđena otopina izmiješala.
English: Fatal reports of TLS complicated by acute renal failure have been reported in the post-marketing setting.
Croatian: Izvještaji o smrtnim ishodima TLS-a, koji je kao komplikaciju imao akutno zatajenje bubrega, prijavljeni su nakon stavljanja lijeka u promet.
English: MYLOTARG + daunorubicin + cytarabine (N=131)
Croatian: MYLOTARG + daunorubicin + citarabin (N=131)
English: The most frequent Grade 3 bleeding/haemorrhagic reactions were epistaxis (1.5%), haemoptysis (3.1%), and haematuria (2.3%).
Croatian: Najčešće reakcije krvarenja/hemoragije stupnja 3 bile su epistaksa (1,5 %), hemoptiza (3,1 %) i hematurija (2,3 %).
English: Non-fractionated dosing refers to MYLOTARG (total dose ranging 1.8 mg/m2 - 9 mg/m2) 2 times during a cycle at least 14 days apart.
Croatian: Nefrakcionirano doziranje odnosi se na lijek MYLOTARG (ukupna doza kreće se u rasponu od 1,8 mg/m 2 do 9 mg/m 2) 2 puta tijekom ciklusa s razmakom od najmanje
English: Use appropriate aseptic technique for the reconstitution and dilution procedures.
Croatian: Za postupke rekonstitucije i razrjeđivanja koristite odgovarajuću aseptičku tehniku.
English: However, the optimal dose of gemtuzumab ozogamicin for paediatric patients was not established, since in Study AAML0531 during the second intensification period after the second dose of gemtuzumab ozogamicin, a larger proportion of patients in the gemtuzumab ozogamicin arm experienced prolonged neutrophil recovery time (> 59 days) as compared with the comparator arm (21.0% versus 11.5%), and more patients died during remission (5.5% versus 2.8%).
Croatian: Međutim, optimalna doza gemtuzumab ozogamicina za pedijatrijske bolesnike nije bila određena jer se u ispitivanju AAML0531 tijekom drugog razdoblja intenzifikacije nakon druge doze gemtuzumab ozogamicina većem dijelu bolesnika u skupini koja je primala gemtuzumab ozogamicin produljilo vrijeme oporavka broja neutrofila (> 59 dana), u usporedbi sa skupinom koja je primala usporedni lijek (21,0 % naspram 11,5 %), te je više bolesnika umrlo tijekom remisije (5,5 % naspram 2,8 %).
English: b. For patients experiencing a complete remission (CR) following induction.
Croatian: Za bolesnike koji su postigli potpunu remisiju nakon uvodnog liječenja.
English: Management of some adverse reactions may require dose interruptions or permanent discontinuation of MYLOTARG (see sections 4.4 and 4.8).
Croatian: Liječenje nekih nuspojava može zahtijevati privremene prekide doziranja ili trajni prekid primjene lijeka MYLOTARG (vidjeti dijelove 4.4 i 4.8).
English: Grade 4 bleeding/haemorrhagic reactions were reported in 4 (3.1%) patients (gastrointestinal haemorrhage, haemorrhage, and pulmonary alveolar haemorrhage [2 patients]).
Croatian: Reakcije krvarenja/hemoragije stupnja 4 zabilježene su u 4 (3,1 %) bolesnika (gastrointestinalna hemoragija, hemoragija i plućna alveolarna hemoragija [2 bolesnika]).
English: In the combination therapy study, VOD and hepatic laboratory abnormalities were collected.
Croatian: Tijekom ispitivanja kombiniranog liječenja prikupljeni su podaci o VOD-u i laboratorijskim abnormalnostima povezanim s funkcijom jetre.
English: Kaplan-Meier plot of event-free survival by investigator assessment from study ALFA-0701 (mITT population)
Croatian: Kaplan-Meierova krivulja preživljenja bez događaja prema procjeni ispitivača, ispitivanje ALFA-0701 (mITT populacija)
English: MYLOTARG should not be administered during second induction.
Croatian: MYLOTARG se ne smije primjenjivati tijekom drugog uvodnog liječenja.
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.
Croatian: Pgp-a, proteina rezistencije na karcinom dojke (engl. breast cancer resistance protein, BCRP), pumpe za izbacivanje žučnih soli (engl. bile salt export pump, BSEP), proteina povezanog s otpornošću na različite lijekove (engl. multidrug resistance associated protein, (MRP)2, proteina za izbacivanje više lijekova i toksina (engl. multidrug and toxin extrusion protein) (MATE)1 i MATE2K, transportera organskog aniona (OAT)1 i OAT3, transportera organskog kationa (OCT)1 i OCT2 i polipeptida koji prenosi organski anion (OATP)1B1 i OATP1B3 u klinički relevantnim koncentracijama.
English: Premedication with a corticosteroid, antihistamine and acetaminophen (or paracetamol) is recommended 1 hour prior to MYLOTARG dosing (see section 4.2).
Croatian: Premedikacija kortikosteroidom, antihistaminikom i acetaminofenom (ili paracetamolom) preporučuje se 1 sat prije doziranja lijeka MYLOTARG (vidjeti dio 4.2).
English: In the combination therapy study, in patients with de novo AML treated with fractionated doses of gemtuzumab ozogamicin in combination with chemotherapy (N=131), 102 (77.9%) patients experienced all causality severe (Grade ≥ 3) infections.
Croatian: U ispitivanju kombiniranog liječenja od svih bolesnika s de novo AML-om, koji su liječeni podijeljenim dozama gemtuzumab ozogamicina u kombinaciji s kemoterapijom (N=131), 102 (77,9 %) je oboljelo od teških (stupanj ≥ 3) infekcija svih uzroka.
English: • If neutrophil count does not recover to greater than 500/mm3 within 14 days following the planned start date of the consolidation cycle (14 days after haematologic recovery following previous cycle), discontinue MYLOTARG (do not administer MYLOTARG in the consolidation cycles).
Croatian: 3 u roku od 14 dana nakon planiranog datuma početka ciklusa konsolidacije (14 dana nakon hematološkog oporavka nakon prethodnog ciklusa), prekinite terapiju lijekom MYLOTARG (ne primjenjujte lijek MYLOTARG u ciklusima konsolidacije).
English: Store in the original carton to protect from light.
Croatian: Čuvati u originalnoj kutiji radi zaštite od svjetlosti.
English: Gemtuzumab ozogamicin was found to be clastogenic.
Croatian: Ustanovljeno je da je gemtuzumab ozogamicin bio klastogen.
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide is a substrate of P-glycoprotein (P-gp).
Croatian: In vitro je N-acetil-gama-kalikeamicindimetilhidrazid supstrat P-glikoproteina (P-gp).
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
Croatian: • venookluzivna bolest jetre što uključuje simptome povećane jetre, bol u gornjem desnom dijelu trbuha, žutilo kože i bjeloočnica, nakupljanje tekućine u trbuhu, povećanje tjelesne težine, abnormalne rezultate krvnih pretraga funkcije jetre
English: Infections and infestations Very common Infection*a
Croatian: Infekcije i infestacije Vrlo često Infekcija
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.
Croatian: Tijekom ciklusa drugog uvodnog liječenja smiju se primjenjivati samo DNR i AraC u sljedećim preporučenim dozama: 35 mg/m2 na dan DNR-a 1. i 2. dan, te 1 g/m2 AraC-a svakih 12 sati od 1. do
English: MYLOTARG daunorubicin cytarabine hydroxyurea
Croatian: MYLOTARG daunorubicin citarabin hidroksiureja
English: The pharmacokinetics (PK) of gemtuzumab ozogamicin is described by measuring PK characteristics of the antibody (hP67.6) as well as total and unconjugated calicheamicin derivatives.
Croatian: Farmakokinetika gemtuzumab ozogamicina opisana je mjerenjem farmakokinetičkih karakteristika antitijela (hP67.6) kao i ukupnih i nekonjugiranih derivata kalikeamicina.
English: Alanine aminotransferase (ALT) increased Blood bilirubin increased Hyperuricaemia
Croatian: Povišene razine alanin aminotransferaze (ALT) Povišene razine bilirubina u krvi
English: Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
Croatian: Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: + 386 (0)1 52 11 400
English: Unopened vial: Store in a refrigerator (2°C-8°C).
Croatian: Neotvorena bočica: Čuvati u hladnjaku (2°C-8°C).
English: In vitro studies demonstrated that N-acetyl gamma calicheamicin dimethyl hydrazide is extensively metabolised, primarily via nonenzymatic reduction of the disulphide moiety.
Croatian: In vitro ispitivanja su pokazala da se N-acetil-gama-kalikeamicindimetilhidrazid opsežno metabolizira, prvenstveno putem neenzimske redukcije disulfidnog dijela.
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).
Croatian: 14 dana nakon planiranog datuma početka ciklusa konsolidacije: započnite terapiju konsolidacije (vidjeti kako je opisano u tablici 1).
English: MYLOTARG is a powder for concentrate for solution for infusion.
Croatian: MYLOTARG je prašak za koncentrat za otopinu za infuziju.
English: Fatal bleeding/haemorrhagic reactions were reported in 3 (2.3%) patients (cerebral haematoma, intracranial haematoma, and subdural haematoma).
Croatian: Smrtonosne reakcije krvarenja/hemoragije zabilježene su u 3 (2,3 %) bolesnika (cerebralni hematom, intrakranijalni hematom i subduralni hematom).
English: After reconstitution (see section 6.6), the concentrated solution contains 1 mg/mL gemtuzumab ozogamicin.
Croatian: Nakon rekonstitucije (vidjeti dio 6.6) 1 ml koncentrirane otopine sadrži 1 mg gemtuzumab ozogamicina.
English: Patients with CR or CRp received consolidation therapy with 2 courses of treatment including DNR and AraC with or without MYLOTARG according to their initial randomisation.
Croatian: Bolesnici s potpunom remisijom ili potpunom remisijom s nepotpunim oporavkom trombocita primili su terapiju konsolidacije s 2 ciklusa liječenja uključujući DNR i AraC s lijekom MYLOTARG ili bez njega, prema njihovoj početnoj randomizaciji.
English: • Organ failure
Croatian: • zatajenje organa
English: An interval of at least 2 months between the last dose of MYLOTARG and transplantation was recommended.
Croatian: Između zadnje doze lijeka MYLOTARG i transplantacije bio je preporučen razmak od najmanje 2 mjeseca.
English: Based on population pharmacokinetic (PK) analyses, the combination of gemtuzumab ozogamicin with DNR and AraC is not predicted to cause clinically meaningful changes in the PK of these agents.
Croatian: Na osnovi populacijskih farmakokinetičkih analiza ne predviđa se da će kombiniranje gemtuzumab ozogamicina s DNR-om i AraC-om uzrokovati klinički značajne promjene u farmakokinetici ovih lijekova.
English: In the completed randomised paediatric Phase 3 Study AAML0531 (see section 5.1) of gemtuzumab ozogamicin combined with intensive first-line therapy in 1,063 newly diagnosed children (93.7% of patients <18 years of age), and young adults (6.3% of patients) with de novo AML aged 0 to 29 years, the safety profile was similar with that observed in the other studies of gemtuzumab ozogamicin combined with intensive chemotherapy in adult patients with de novo AML.
Croatian: U dovršenom randomiziranom pedijatrijskom ispitivanju faze 3 AAML0531 (vidjeti dio 5.1) provedenom za gemtuzumab ozogamicin kombiniran s intenzivnom prvom linijom terapije u 1063 novodijagnosticirane djece (93,7 % bolesnika u dobi od < 18 godina) i mlađih odraslih (6,3 % bolesnika) s de novo AML-om u dobi od 0 do 29 godina, sigurnosni profil bio je sličan onome zabilježenom tijekom drugih ispitivanja gemtuzumab ozogamicina kombiniranog s intenzivnom kemoterapijom u odraslih bolesnika s de novo AML-om.
English: Effect on co-administered chemotherapeutic agents
Croatian: Učinak na kemoterapeutike koji se istodobno primjenjuju
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).
Croatian: Na osnovi populacijske farmakokinetičke analize 406 bolesnika klirens gemtuzumab ozogamicina u bolesnika s blagim oštećenjem funkcije bubrega (klirens kreatinina [CrCl] 60-89 ml/min; n=149) ili umjerenim oštećenjem funkcije bubrega (CrCl 30-59 ml/min; n=47) bio je sličan onome u bolesnika s normalnom funkcijom bubrega (CrCl ≥ 90 ml/min; n=209).
English: In clinical studies of MYLOTARG in patients with relapsed or refractory AML, the immunogenicity of MYLOTARG was evaluated using 2 enzyme-linked immunosorbent assays (ELISAs).
Croatian: Tijekom kliničkih ispitivanja lijeka MYLOTARG u bolesnika s recidivnim ili refraktornim AML-om imunogenost lijeka MYLOTARG procjenjivala se primjenom 2 enzimska imunotesta ELISA (engl.
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.
Croatian: In vitro je N-acetil-gama-kalikeamicindimetilhidrazid imao nizak potencijal za inhibiciju aktivnosti UGT1A1, UGT1A4, UGT1A6, UGT1A9 i UGT2B7 u klinički relevantnim koncentracijama.
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).
Croatian: Na osnovi populacijske farmakokinetičke analize ne očekuje se da stanje blagog oštećenja funkcije jetre utječe na klirens gemtuzumab ozogamicina (hP67.6 antitijelo i nekonjugirani kalikeamicin), kako je definirala Radna skupina za disfunkciju organa Nacionalnog instituta za rak (engl.
English: • After reconstitution, each ml of the concentrated solution contains 1 mg gemtuzumab ozogamicin.
Croatian: • Nakon rekonstitucije 1 ml koncentrirane otopine sadrži 1 mg gemtuzumab ozogamicina.
English: v. Erythema includes the following reported PTs: Catheter site erythema, Erythema and Infusion site erythema#.
Croatian: Eritem uključuje sljedeće zabilježene preporučene pojmove: eritem na mjestu katetera, eritem i eritem na mjestu primjene infuzije w.
English: Dose modifications for haematological toxicities Haematological toxicities
Croatian: Tablica 3. Promjene doze za hematološke toksičnosti Hematološke toksičnosti
English: Event-free survival (by Investigator)
Croatian: Preživljenje bez događaja (prema ispitivaču)
English: Total dosing of MYLOTARG ranged from 1.8 mg/m2 to 9 mg/m2.
Croatian: Ukupno doziranje lijeka MYLOTARG kretalo se u rasponu od 1,8 mg/m2 do
English: The most common adverse reactions (> 30%) in the combination therapy study were haemorrhage and infection.
Croatian: U ispitivanju kombiniranog liječenja najčešće nuspojave (> 30%) bile su hemoragija i infekcija.
English: Women of childbearing potential, or partners of females of childbearing potential should be advised to use 2 methods of effective contraception during treatment with MYLOTARG for at least 7 months (females) or 4 months (males) after the last dose (see section 4.6).
Croatian: Potrebno je savjetovati ženama reproduktivne dobi ili partnerima žena reproduktivne dobi da koriste 2 metode učinkovite kontracepcije tijekom liječenja lijekom MYLOTARG te najmanje 7 mjeseci (žene) ili 4 mjeseca (muškarci) nakon zadnje doze (vidjeti dio 4.6).
English: Definitive conclusions cannot be drawn between the presence of antibodies and potential impact on efficacy and safety due to the limited number of patients with positive ADAs.
Croatian: Zbog ograničenog broja bolesnika s pozitivnom ADA-om, ne mogu se donijeti konačni zaključci o povezanosti između prisutnosti antitijela i potencijalnog utjecaja na djelotvornost i sigurnost.
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.
Croatian: Na temelju analize potencijalnih čimbenika rizika u odraslih bolesnika koji su primali lijek MYLOTARG kao monoterapiju, u bolesnika koji su podvrgnuti HSCT-u prije izlaganja gemtuzumab ozogamicinu bila je 2,6 puta veća vjerojatnost (95 % CI: 1,448; 4,769) da će razviti VOD u usporedbi s bolesnicima bez HSCT-a prije liječenja gemtuzumab ozogamicinom; za bolesnike koji su podvrgnuti HSCT-u nakon liječenja gemtuzumab ozogamicinom bila je 2,9 puta veća vjerojatnost (95 % CI: 1,502; 5,636) da će razviti VOD u usporedbi s bolesnicima bez HSCT-a nakon liječenja gemtuzumab ozogamicinom; dok je u bolesnika koji su imali umjereno/teško oštećenje funkcije jetre prije početka terapije postojala 8,7 puta veća vjerojatnost (95 % CI: 1,879; 39,862) da će razviti VOD u usporedbi s bolesnicima bez umjerenog/teškog oštećenja funkcije jetre prije početka terapije.
English: Gently invert the infusion container to mix the diluted solution.
Croatian: Pažljivo preokrenite spremnik za infuziju kako bi se promiješala razrijeđena otopina.
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).
Croatian: Kada postanu dostupni rezultati testiranja citogenetike u bolesnika s novodijagnosticiranim de novo AML-om koji se liječe lijekom MYLOTARG u kombinaciji s daunorubicinom i citarabinom, potrebno je razmotriti nadmašuje li potencijalna korist nastavka liječenja lijekom MYLOTARG rizike za pojedinog bolesnika (vidjeti dio 5.1).
English: • infusion reaction: experience during or shortly after MYLOTARG infusion symptoms such as dizziness, decreased urination, confusion, vomiting, nausea, swelling, shortness of breath, or heart rhythm disturbances (this may be a potentially life-threatening complication known as tumour lysis syndrome).
Croatian: • imate reakciju na infuziju: primijetite tijekom ili ubrzo nakon infuzije lijeka MYLOTARG simptome kao što su omaglica, smanjeno mokrenje, smetenost, povraćanje, mučnina, oticanje, nedostatak zraka ili poremećaje u srčanom ritmu (to može ukazivati na komplikaciju koja može biti opasna po život, poznatu kao sindrom lize tumora).
English: Investigations *** Very common
Croatian: Pretrage ***
English: Appropriate measures to help prevent the development of tumour lysis-related hyperuricaemia, such as hydration, administration of antihyperuricemics (e.g., allopurinol) or other agents for treatment of hyperuricaemia (e.g., rasburicase) must be taken.
Croatian: Moraju se poduzeti odgovarajuće mjere koje pomažu u sprječavanju razvoja hiperuricemije povezane s lizom tumora, kao što su hidracija, primjena lijekova protiv hiperuricemije (npr. alopurinol) ili drugih lijekova koji se koriste u liječenju hiperuricemije (npr. razburikaze).
English: d. 2-sided p-value from the log-rank test. e. Response defined as CR+CRp.
Croatian: Odgovor definiran kao CR+CRp.
English: Appropriate measures to help prevent the development of tumour lysis-related hyperuricaemia, such as hydration, administration of antihyperuricemic or other agents for treatment of hyperuricaemia should be taken (see section 4.4).
Croatian: Treba poduzeti odgovarajuće mjere za sprječavanje razvoja hiperuricemije povezane s lizom tumora, kao što su hidracija, primjena lijekova protiv hiperuricemije ili drugih lijekova koji se koriste u liječenju hiperuricemije (vidjeti dio 4.4).
English: Dextran 40, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous.
Croatian: Dekstran 40, saharoza, natrijev klorid, natrijev dihidrogenfosfat hidrat, bezvodni, natrijev hidrogenfosfat.
English: Based on population pharmacokinetic (PK) analyses, the combination of gemtuzumab ozogamicin with hydroxyurea, DNR, and AraC is not predicted to cause clinically meaningful changes in the PK of hP67.6 or unconjugated calicheamicin.
Croatian: Na osnovi populacijskih farmakokinetičkih analiza ne predviđa se da će kombiniranje gemtuzumab ozogamicina s hidroksiurejom, DNR-om i AraC-om uzrokovati klinički značajne promjene u farmakokinetici hP67.6 ili nekonjugiranog kalikeamicina.
English: Overall survival by AML risk classifications from study ALFA-0701 (mITT Population) MYLOTARG + daunorubicin + cytarabine daunorubicin + cytarabine
Croatian: Tablica 9. Preživljenje bez događaja prema procjeni ispitivača na temelju klasifikacije rizika kod AML-a iz ispitivanja ALFA-0701 (mITT populacija) MYLOTARG + daunorubicin + citarabin daunorubicin + citarabin
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.
Croatian: Preporučena doza lijeka MYLOTARG je 3 mg/m 2 po dozi (do maksimalno jedne bočice od 5 mg) koja se infundira tijekom 2 sata 1., 4. i 7. dana, u kombinaciji sa 60 mg/m 2 na dan DNR-a infundiranog tijekom 30 minuta od 1. do 3. dana, te 200 mg/m 2 na dan AraC-a primijenjenog kontinuiranom infuzijom od 1. do 7. dana.
English: x. Oedema includes the following reported PTs: Oedema, Face oedema, Oedema peripheral, Swelling face, Generalised oedema, and Periorbital oedema.
Croatian: Edem uključuje sljedeće zabilježene preporučene pojmove: edem, edem lica, periferni edem, oticanje lica, generalizirani edem i periorbitalni edem.