FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Fl-istudji kliniċi ta' MYLOTARG f'pazjenti b'AML rikaduta jew refrattorja, l-immunoġeniċità ta' MYLOTARG ġiet evalwata permezz ta' 2 assaġġi ta' immunoassorbiment marbutin mal-enzimi (ELISAs).
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).
Maltese: • reazzjoni għall-infużjoni: waqt l-infużjoni ta' MYLOTARG jew ftit wara tesperjenza sintomi bħal sturdament, tnaqqis fl-awrina, konfużjoni, rimettar, dardir, nefħa, qtugħ ta' nifs, jew disturbi tar-ritmu tal-qalb (din tista' tkun kumplikazzjoni potenzjalment ta' periklu għall-ħajja magħrufa bħala sindrome ta' liżi tat-tumur).
English: Alanine aminotransferase (ALT) increased Blood bilirubin increased Hyperuricaemia
Maltese: Żieda fl-alanine aminotransferase (ALT)
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.
Maltese: Abbażi tal-analiżijiet farmakokinetiċi tal-popolazzjoni (PK), il-kombinazzjoni ta' gemtuzumab ozogamicin ma' hydroxyurea, DNR, u AraC mhix imbassra li tikkawża tibdil klinikament sinifikanti fil-PK ta' hP67.6 jew calicheamicin mhux konjugat.
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.
Maltese: o Dożi ikbar jew daqs 3.9 mg għandhom jiġu dilwiti f'siringa jew f'borża IV f'volum xieraq ta' soluzzjoni ta' sodium chloride ta' 9 mg/mL (0.9%) għall-injezzjoni sabiex tiġi żgurata konċentrazzjoni finali bejn 0.075 mg/mL sa 0.234 mg/mL.
English: Lower gastrointestinal haemorrhage (15.2%), Subcutaneous haemorrhage (28.5%), Other haemorrhage (32.9%), and
Maltese: 2%), Emorraġija taħt il-ġilda (28.5%), Emorraġija oħra (32.9%), u Epistassi l.
English: Other side effects may include:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: Infusion related reactions
Maltese: Reazzjonijiet relatati malinfużjoni
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.
Maltese: Ilproporzjon tal-antikorp jagħqad speċifikament mal-antiġen CD33, proteina tal-adeżjoni dipendenti fuq l-aċidu sijalika li tinstab fuq is-superfiċje ta' blasts lewkimiċi majelojde u ċelluli normali immaturi tan-nisel majelomonoċitiku, iżda mhux fuq ċelluli staminali emopojetiċi normali.
English: The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in monotherapy studies were infection, haemorrhage, multi-organ failure, and VOD.
Maltese: Ir-reazzjonijiet avversi laktar frekwenti (≥ 1%) li wasslu għat-twaqqif permanenti fl-istudji ta' monoterapija kienu infezzjoni, emorraġija, insuffiċjenza ta' bosta organi u VOD.
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.
Maltese: • reazzjoni allerġika: ikollok ħoss ta' tisfir irqiq għoli ħafna waqt li tieħu n-nifs (tħarħir), ikollok diffikultà biex tieħu n-nifs, qtugħ ta' nifs jew sogħla bi jew mingħajr mukus, ħorriqija, ħakk,
English: Male reproductive effects (testes, epididymides, seminal vesicles) in monkeys were observed at approximately 66 times the human clinical exposure after the third dose of 3 mg/m2).
Maltese: Ġew osservati effetti riproduttivi tar-raġel (testikoli, epididimu, bżieżaq seminali) fix-xadini b'madwar 66 darba l-esponiment kliniku tal-bniedem wara t-tielet doża ta' 3 mg/m
English: Routine clinical and laboratory surveillance testing during and after treatment is indicated.
Maltese: Huwa indikat ittestjar ta' sorveljanza klinika u laboratorju ta' rutina waqt u wara l-kura.
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.
Maltese: DNR u AraC biss għandhom jingħataw matul it-tieni ċiklu ta' induzzjoni, bid-dożaġġ rakkomandat li ġej: DNR 35 mg/m2/jum f'Jiem 1 u 2, u AraC 1 g/m2 kull 12-il siegħa, f'Jum 1 sa
English: g. Lymphopenia includes the following reported PTs: Lymphopenia and Lymphocyte count decreased.
Maltese: Reazzjoni relatata mal-infużjoni tinkludi l-PTs irrappurtati li ġejjin:
English: • Calculate the dose (mg) of MYLOTARG required.
Maltese: • Ikkalkula d-doża (mg) ta' MYLOTARG meħtieġa.
English: • Abnormalities in liver blood tests (which can be indicators of liver injury)
Maltese: • Anormalitajiet fit-testijiet tad-demm tal-fwied (li jistgħu jkunu indikaturi ta' korriment fil fwied)
English: The median time to neutrophil recovery to ANC of 500/mm3 and 1,000/mm3 was 25 days.
Maltese: Iż-żmien medjan għal irkupru tan newtrofili għal ANC ta' 500/mm 3 u 1,000/mm 3 kien 25 jum.
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.
Maltese: 9/L għan-newtrofili) kien ivarja minn 42-48 jum għall-plejtlits u 30-37 jum għan-newtrofili.
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.
Maltese: Fi studju li fih il-parteċipanti ntgħażlu b'mod każwali (COG AAML0531) li evalwa kimoterapija standard waħidha jew kombinata ma' MYLOTARG fi 1,063 tifel/tifla li kienu għadhom kif ġew dijanjostikati b'AML (93.7% tal-pazjenti ta' età ta' < 18-il sena), u adulti żgħażagħ (6.3% talpazjenti); l-età medja kienet 8.9 snin (medda: 0-29 sena), pazjenti b'AML de novo ġew assenjati b'mod li fih il-parteċipanti ntgħażlu b'mod każwali għal jew kimoterapija standard ta' 5 korsijiet waħidha jew għall-istess kimoterapija b'2 dożi ta' MYLOTARG (3 mg/m2/doża) mogħtija darba flinduzzjoni Kors 1 u fl-intensifikazzjoni Kors 2.
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.
Maltese: VOD ġiet irrappurtata wkoll f'2 pazjenti li rċivew MYLOTARG bħala terapija ta' segwitu wara rikaduta tal-AML wara kura bil-kimoterapija fil-fergħa tal-kontroll tal-istudju ta' terapija kombinata.
English: • Doses must be mixed to a concentration between 0.075 mg/mL to 0.234 mg/mL according to the following instructions: o Doses less than 3.9 mg must be prepared for administration by syringe.
Maltese: • Id-dożi għandhom jitħalltu f'konċentrazzjoni bejn 0.075 mg/mL sa 0.234 mg/mL skont listruzzjonijiet li ġejjin:
English: AML with adverse-risk cytogenetics
Maltese: Tfal u adolexxenti
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.
Maltese: Tagħrif mhux kliniku jissuġġerixxi li l-attività kontra l-kanċer ta' gemtuzumab ozogamicin hija minħabba t-tagħqid tal-ADC maċ-ċelluli tat-tumur li jesprimu s-CD33, segwit mill-internalizzazzjoni tal-kumpless CD33 tal-ADC, u r-rilaxx intraċellulari ta' N-acetyl gamma calicheamicin dimethyl hydrazide permezz talqtugħ (cleavage) idrolitiku tal-linker.
English: The efficacy and safety of MYLOTARG were evaluated in a multicentre, randomised, open-label Phase 3 study comparing the addition of MYLOTARG to a standard chemotherapy induction regimen of daunorubicin and cytarabine (DA) versus DA alone.
Maltese: L-effikaċja u s-sigurtà ta' MYLOTARG ġew evalwati fi studju ta' Fażi 3 multiċentriku, li fih ilparteċipanti ntgħażlu b'mod każwali, open-label li qabbel iż-żieda ta' MYLOTARG ma' kors ta' induzzjoni ta' kimoterapija standard ta' daunorubicin u cytarabine (DA) kontra DA waħdu.
English: In vitro studies demonstrated that N-acetyl gamma calicheamicin dimethyl hydrazide is extensively metabolised, primarily via nonenzymatic reduction of the disulphide moiety.
Maltese: Studji in vitro wrew li N-acetyl gamma calicheamicin dimethyl hydrazide jiġi metabolizzat b'mod estensiv, primarjament permezz ta' tnaqqis mhux enzimatiku tal-frazzjoni tad-disulphide.
English: Chills
Maltese: HSCT
English: Fatal reports of TLS complicated by acute renal failure have been reported in the post-marketing setting.
Maltese: Test tal-funzjoni tal-fwied anormali u funzjoni epatika anormali.
English: See section 2, “MYLOTARG contains sodium”.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni mediċinali b'MYLOTARG.
English: Gamma-glutamyltransferase increased Uncommon
Maltese: • Funzjoni tal-fwied anormali
English: MYLOTARG 5 mg powder for concentrate for solution for infusion
Maltese: MYLOTARG 5 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: In the combination therapy study, safety data consisting of selected treatment emergent adverse events (TEAEs) considered most important for understanding the safety profile of MYLOTARG consisted of all grades haemorrhages, all grades VOD, and severe infections.
Maltese: Fl-istudju ta' terapija kombinata, inġabret dejta dwar is-sigurtà b'mod retrospettiv li tikkonsisti minn avvenimenti avversi emerġenti tal-kura (TEAEs, treatment emergent adverse events) magħżula li ġiet ikkunsidrata bħala l-aktar importanti għall-fehim tal-profil tas-sigurtà ta' MYLOTARG li kkonsista minn emorraġiji tal-gradi kollha, VOD tal-gradi kollha u infezzjonijiet severi.
English: MYLOTARG is not for use in patients with a type of cancer called acute promyelocytic leukaemia (APL).
Maltese: MYLOTARG mhuwiex għal użu f'pazjenti b'tip ta' kanċer imsejjaħ lewkimja promajeloċitika akuta (APL, acute promyelocytic leukaemia).
English: Deathd
Maltese: Dardir
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).
Maltese: • Qabel ma tirċievi MYLOTARG, inti se tingħata mediċini biex jgħinu jnaqqsu sintomi bħal deni u dehxiet ta' bard, magħrufa bħala reazzjonijiet għall-infużjoni, waqt u ftit wara l-infużjoni b'MYLOTARG.
English: Budd-Chiari s yndrome#
Maltese: TIKKETTA TAL-KUNJETT
English: After reconstitution each vial contains 1 mg/mL gemtuzumab ozogamicin.
Maltese: Wara r-rikostituzzjoni kull kunjett fih 1 mg/mL ta' gemtuzumab ozogamicin.
English: The ALFA-0701 trial was not designed to prospectively evaluate the benefit of MYLOTARG in subgroups; analysis are presented for descriptive purposes only.
Maltese: Il-prova ALFA-0701 ma tfasslitx biex tevalwa b'mod propsettiv il-benefiċċju ta' MYLOTARG f'sottogruppi; l-analiżi qed tiġi ppreżentata għal skopijiet deskrittivi biss.
English: What MYLOTARG contains
Maltese: MYLOTARG frazzjonat
English: In patients, unconjugated calicheamicin plasma levels were typically low, with a predicted mean Cmax of 1.5 ng/mL following the third dose.
Maltese: Fil-pazjenti, il-livelli ta' calicheamicin mhux konjugat fil-plażma kienu tipikament baxxi, b'Cmax medja mbassra ta' 1.5 ng/mL wara t-tielet doża.
English: o. Abdominal pain includes the following reported PTs: Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal discomfort, and Abdominal tenderness.
Maltese: Uġigħ addominali, Uġigħ addominali t'isfel, Uġigħ addominali ta' fuq, Skumdità addominali u Sensittività addominali.
English: Cytogenetics (unfavourable), N Number of deaths, n (%) Median OS in months [95% CI]a Hazard ratio [95% CI]b p-valuec
Maltese: Ċitoġenetiċi (mhux favorevoli), N Numru ta' avvenimenti, n (%) EFS medjana f'xhur [CI ta' 95%] Proporzjon ta' periklu [CI ta' 95%] valur-p
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).
Maltese: 3 fi żmien 14-il jum wara d-data tal-bidu ppjanata taċ-ċiklu ta' konsolidazzjoni (14-il jum wara rkupru ematoloġiku wara ċiklu preċedenti), waqqaf MYLOTARG (tagħtix MYLOTARG fiċ-ċikli ta' konsolidazzjoni).
English: Overall, the incidence rate of ADA development after MYLOTARG treatment was < 1% across the 4 clinical studies with ADA data.
Maltese: B'mod globali, irrata ta' inċidenza ta' żvilupp ta' ADA wara kura b'MYLOTARG kienet < 1% fl-4 studji kliniċi b'dejta ta' ADA.
English: 60 mg/m2/day on Day 1 to Day 2
Maltese: 60 mg/m 2/jum f'Jum 1
English: Fatal bleeding/haemorrhagic reactions were reported in 3 (2.3%) patients (cerebral haematoma, intracranial haematoma, and subdural haematoma).
Maltese: Reazzjonijiet ta' ħruġ ta' demm/emorraġiċi ġew irrappurtati fi 3 (2.3%) pazjenti (ematoma ċerebrali, ematoma intrakranjali u ematoma subdurali).
English: Venoocclusive liver dis ease*c
Maltese: Użu f'pazjenti b'indeboliment tal-fwied
English: MYLOTARG is intended for the treatment of AML for patients age 15 years and above who have not tried other treatments.
Maltese: MYLOTARG huwa intenzjonat għallkura ta' AML għal pazjenti ta' 15-il sena u aktar li ma ppruvawx kuri oħra.
English: MYLOTARG does not undergo renal clearance, the pharmacokinetics in patients with severe renal impairment is unknown (see section 5.2).
Maltese: MYLOTARG ma jgħaddix minn tneħħija mill-kliewi, il-farmakokinetika f'pazjenti b'indeboliment tal-kliewi sever mhix magħrufa (ara sezzjoni 5.2).
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.
Maltese: Fil-fażi ta' konsolidazzjoni 2 tat-terapija, 80 (97.6%) pazjent kellhom irkupru tan-newtrofili għal għadd ta' 500/mm 3, u 79 (96.3%) pazjent irkupraw għal għadd ta' 1,000/mm 3. Iż-żmien medjan għal irkupru tan-newtrofili għal ANC ta'
English: Based on a population PK analysis, age, race, and gender did not significantly affect gemtuzumab ozogamicin disposition.
Maltese: Abbażi tal-analiżi PK tal-popolazzjoni, l-età, ir-razza, u s-sess ma affettwawx b'mod sinifikanti ddispożizzjoni ta' inotuzumab ozogamicin
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).
Maltese: Twettaq rieżami sistemiku tal-letteratura tal-istudji biex jiġi evalwat MYLOTARG f'pazjenti pedjatriċi b'AML rikaduta jew refrattorja, li inkluda 454 pazjent li kienu qed jirċievu MYLOTARG jew bħala monoterapija (dożaġġ wieħed jew frazzjonat) jew bħala terapija kkombinata minn 16il studju ppubblikat flimkien mal-Istudju ta' Aċċess Estiż tal-Istati Uniti (US Expanded Access Study) (ara sezzjoni 4.8).
English: The terminal plasma half-life (t½) for hP67.6 was predicted to be approximately 160 hours for a typical patient at the recommended dose level (3 mg/m2) of MYLOTARG.
Maltese: Il-half-life tal-plażma terminali (t½) għal hP67.6 kienet imbassra li hi madwar 160 siegħa, għal pazjent tipiku bil-livell ta' doża rakkomandat (3 mg/m2) ta' MYLOTARG.
English: Anaemiad
Maltese: Rimettar
English: The results of the population modelling showed that the PK behaviour of gemtuzumab ozogamicin (hP67.6 antibody and unconjugated calicheamicin) is similar between adult and paediatric AML patients following the 9 mg/m2 dosing regimen.
Maltese: Ir-riżultati tal-immudellar tal-popolazzjoni wrew li l-imġiba tal-PK ta' gemtuzumab ozogamicin (antikorp hP67.6 u calicheamicin mhux konjugat) hija simili bejn pazjenti tal-AML adulti u pedjatriċi wara l-kors tad-dożaġġ ta' 9 mg/m
English: Management of patients with severe infection, bleeding/haemorrhage, or other effects of myelosuppression, including severe neutropenia or persistent thrombocytopenia, may require a dose delay or permanent discontinuation of MYLOTARG (see section 4.2).
Maltese: Il-ġestjoni ta' pazjenti b'infezzjoni severa, ħruġ ta' demm/emorraġija, jew effetti oħra ta' majelosuppressjoni, inkluż newtropenija jew tromboċitopenija severi, tista' tkun teħtieġ dewmien fiddoża jew it-twaqqif permanenti ta' MYLOTARG (ara sezzjoni 4.2).
English: t. Hepatic function abnormal includes the following reported PTs: Liver function test abnormal and Hepatic function abnormal.
Maltese: Funzjoni epatika anormali tinkludi l-PTs irrappurtati li ġejjin:
English: Thrombocytopenia with platelet counts < 50,000/mm3 persisting 45 days after the start of therapy for responding patients (CR and incomplete platelet recovery [CRp]) occurred in 22 (20.4%) of patients.
Maltese: 3 li ppersistiet 45 jum wara l-bidu tat-terapija għal pazjenti li rrispondew (CR u irkupru tal-plejtlits mhux komplut [CRp]) seħħet f'22 (20.
English: You may need to read it again.
Maltese: Probabbiltà ta' Sopravivenza
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.
Maltese: 3), hija rakkomandata ċitoriduzzjoni jew b'lewkafereżi, hydroxyurea orali jew AraC ma' jew mingħajr hydroxyurea biex tnaqqas l-għadd ta' ċelluli bojod tad-demm (WBC, white blood cell) periferali 48 siegħa qabel l-għoti ta' MYLOTARG.
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.
Maltese: Fi studju dwar il-fertilità tar-raġel, effetti fuq ir-riproduzzjoni tar-raġel inkludew spermatogonja u spermatoċiti aktar baxxi, tnaqqis fl-ispermatidi testikolari u fl-isperma tal-epididimu, vakwolazzjoni tan-nukleu fl-ispermatidi, u/jew dehra ta' ċelluli ġganti.
English: • Rapid heartbeat
Maltese: • Dehxiet ta' bard
English: Previously untreated AML
Maltese: AML li ma ġietx ikkurata preċedentement
English: MYLOTARG should not be administered during second induction.
Maltese: MYLOTARG m'għandux jingħata waqt it-tieni induzzjoni.
English: Number of events, n (%) Median EFS in months [95% CI]a, 2-year EFS probability[95% CI]b 3-year EFS probability [95% CI]b
Maltese: Numru ta' avvenimenti, n (%) EFS medjana f'xhur [CI ta' 95%] Proporzjon ta' Periklu [CI ta' 95%] valur-p
English: Abbreviations: AML=acute myeloid leukaemia; CI=confidence interval; ELN=European LeukaemiaNet; mITT=modified intent-to-treat; n=number; N=number; NE=not estimable; OS=Overall Survival a. Median estimated by Kaplan-Meier method; CI based on the Brookmeyer and Crowley Method with log-log transformation.
Maltese: L-inċidenza ta' pożittività tal-antikorp f'assaġġ tista' tiġi influwenzata minn diversi fatturi, inkluż il-metodoloġija tal-assaġġ, il-konċentrazzjonijiet ta' gemtuzumab ozogamicin li jiċċirkolaw, l-immaniġġjar talkampjun, meta jinġabar il-kampjun, kuri konkomitanti u l-marda sottostanti.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
Maltese: DATA TA' REVIŻJONI TAT-TEST
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.
Maltese: Abbażi tal-analiżijiet farmakokinetiċi (PK) tal-popolazzjoni, il-kombinazzjoni ta' gemtuzumab ozogamicin ma' DNR u AraC mhijiex imbassra li se tikkawża tibdil klinikament sinifikanti fil-PK ta' dawn il-mediċini.
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.
Maltese: • Jekk l-għadd tal-plejtlits jirkupra għal < 50,000/mm 3 għal aktar minn 14-il jum, it-terapija ta' konsolidazzjoni għandha tiġi evalwata mill-ġdid u għandu jsir BMA biex jiġi evalwat mil-ġdid l-istatus tal-pazjenti.
English: 1 g/m2/every 12 hours on Day 1 to Day 4
Maltese: 1 g/m2/kull 12-il siegħa f'Jum 1 sa Jum 4
English: Monitoring only total bilirubin may not identify all patients at risk of VOD/SOS.
Maltese: Il-monitoraġġ tal-bilirubina totali biss jista' ma jidentifikax il-pazjenti kollha f'riskju ta' VOD/SOS.
English: Postpone MYLOTARG until recovery of total bilirubin to ≤ 2 × ULN
Maltese: X'inhu MYLOTARG u għalxiex jintuża 2.
English: Due to the risk of VOD/SOS, signs and symptoms of VOD/SOS should be closely monitored; these may include elevations in ALT, AST, total bilirubin, and alkaline phosphatase, which should be monitored prior to each dose of MYLOTARG, hepatomegaly (which may be painful), rapid weight gain, and ascites.
Maltese: Minħabba r-riskju ta' VOD/SOS, is-sinjali u s-sintomi ta' VOD/SOS għandhom jiġu mmonitorjati mill-qrib; dawn jistgħu jinkludu żidiet fl-ALT, AST, bilirubina totali u alkaline phosphatase, li għandhom jiġu mmonitorjati qabel kull doża ta' MYLOTARG, epatomegalija (li tista' tkun bl-uġigħ), żieda mgħaġġla fil-piż, u axxite.
English: The main toxicities occurred in the liver, bone marrow and lymphoid organs, haematology parameters (decreased RBC mass and WBC counts, mainly lymphocytes), kidney, eye and male and female reproductive organs.
Maltese: RBC u fl-għadd tal-WBC, prinċipalment limfoċiti), fil-kliewi, flgħajnejn u fl-organi riproduttivi tar-raġel u tal-mara.
English: Based on Population PK analyses, the predicted clearance (CL) value of hP67.6 from plasma was 3 L/h immediately after the first dose and then 0.3 L/h.
Maltese: Abbażi ta' analiżijiet PK tal-popolazzjoni, il-valur tat-tneħħija (CL, clearance) imbassar ta' hP67.6 mill-plażma kien 3 L/h immedjatament wara l-ewwel doża u mbagħad 0.3 L/h.
English: Use in patients with hepatic impairment
Maltese: Infezzjonijiet u infestazzjonijiet Komuni ħafna Infezzjoni
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).
Maltese: Ġew irrappurtati epatotossiċità, inkluż insuffiċjenza tal-fwied ta' periklu għall-ħajja, u xi kultant fatali, u VOD/SOS f'pazjenti kkurati b'MYLOTARG (ara sezzjoni 4.8).
English: v. Erythema includes the following reported PTs: Catheter site erythema, Erythema and Infusion site erythema#.
Maltese: Eritema tinkludi l-PTs irrappurtati li ġejjin: Eritema fis-sit tal-katerer, Eritema u Eritema fis-sit tal-infużjoni w.
English: 1 g/m2/every 12 hours on Day 1 to Day 3
Maltese: 1 g/m2/kull 12-il siegħa f'Jum 1 sa Jum 3
English: n. Dyspnoea includes the following reported PTs: Dyspnoea and Dyspnoea exertional.
Maltese: Newtropenija tinkludi l-PTs irrappurtati li ġejjin:
English: Event-free survival (by Investigator)
Maltese: Sopravivenza mingħajr avvenimenti (mill-Investigatur)
English: VO D VO D post HSCT
Maltese: GO + D+ C D + C