FrancophonIA/ELRC3.0 huggingface dataset:
English: Nausea Stomatitisp
Maltese: Kunjett mhux miftuħ
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.
Maltese: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide kellu potenzjal baxx li jinduċi l-attivitajiet ta' UGT1A1, UGT1A4, UGT1A6, UGT1A9, u UGT2B7 b'konċentrazzjonijiet klinikament rilevanti.
English: d: Within 30 days from the last dose of MYLOTARG.
Maltese: d: Fi żmien 30 jum mill-aħħar doża ta' MYLOTARG.
English: a. See Table 3 and Table 4 for dose modification information.
Maltese: Ara Tabella 3 u Tabella 4 għal informazzjoni dwar modifikazzjoni fid-doża.
English: a. Infection includes Sepsis and Bacteraemia (25.6%), Fungal infection (10.5%), Lower respiratory tract infection
Maltese: Infezzjoni tinkludi Sepsis u Batteremija (25.6%), Infezzjoni fungali (10.
English: Risk difference [95% CI]f p-valueg
Maltese: Differenza fir-riskju [CI ta' 95%] valur-p
English: In subgroup analyses in ALFA-0701, the addition of MYLOTARG to standard combination chemotherapy did not improve EFS in the subgroup of patients having adverse-risk cytogenetics (HR 1.11; 95% CI: 0.63, 1.95).
Maltese: F'analiżijiet tas-sottogrupp f'ALFA-0701, iż-żieda ta' MYLOTARG ma' kimoterapija kombinata standard ma tejbitx l-EFS fis-sottogrupp ta' pazjenti li jkollhom ċitoġenetiċi ta' riskji avversi (HR 1.11; CI ta' 95%: 0.63, 1.95).
English: • Following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, MYLOTARG solution should be infused immediately.
Maltese: • Wara d-dilwizzjoni b'soluzzjoni ta' sodium chloride ta' 9 mg/mL (0.9%) għall-injezzjoni, issoluzzjoni ta' MYLOTARG għandha tiġi infuża immedjatament.
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).
Maltese: MYLOTARG huwa indikat għal terapija kombinata b'daunorubicin (DNR) u cytarabine (AraC) għallkura ta' pazjenti ta' 15-il sena u aktar b'lewkimja majelojde akuta (AML, acute myeloid leukaemia) pożittiva għas-CD33 de novo li ma ġietx ikkurata preċedentement, ħlief lewkimja promajeloċitika akuta (APL, acute promyelocytic leukaemia) (ara sezzjoni 4.4 u 5.1).
English: ALFA-0701 study of previously untreated patients with de novo AML
Maltese: Studju ALFA-0701 ta' pazjenti b'AML de novo li ma ġietx ikkurata preċedentement
English: Ratec
Maltese: Rata
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide and gemtuzumab ozogamicin had a low potential to inhibit the activities of CYP1A2, CYP2A6 (tested only using gemtuzumab ozogamicin), CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5 at clinically relevant concentrations.
Maltese: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide u gemtuzumab ozogamicin kellhom potenzjal baxx li jinibixxu l-attivitajiet ta' CYP1A2, CYP2A6 (ittestjat biss permezz ta' gemtuzumab ozogamicin), CYP2B6 , CYP2C8, CYP2C9, CYP2C19, CYP2D6, u CYP3A4/5 b'konċentrazzjonijiet klinikament rilevanti.
English: Median EFS was 17.3 months (95% CI: 13.4, 30.0) in the MYLOTARG arm versus 9.5 months (95% CI: 8.1, 12.0) in the DA alone arm; hazard ratio (HR) 0.562 (95% CI: 0.415, 0.762); 2-sided p=0.0002 by log-rank test. Efficacy data from ALFA-0701 study are summarised in Table 8, and the Kaplan-Meier plot for EFS is shown in Figure 1.
Maltese: LEFS medjana kienet 17.3 xhur (CI ta' 95% 13.4-30.0) fil-fergħa ta' MYLOTARG kontra 9.5 xhur (CI ta' 95% 8.1-12.0) fil-fergħa ta' DA waħdu; proporzjon ta' riksju (HR, hazard proportion) 0.562 (CI ta' 95% 0.415-0.762); p miż-żewġ naħat=0.0002 skont test log-rank.
English: Grade 4 bleeding/haemorrhagic reactions were reported in 4 (3.1%) patients (gastrointestinal haemorrhage, haemorrhage, and pulmonary alveolar haemorrhage [2 patients]).
Maltese: Reazzjonijiet ta' ħruġ ta' demm/emorraġiċi ta' Grad 4 ġew irrappurtati f'4 (3.1%) pazjenti (emorraġija gastrointestinali, emorraġija, u emorraġija alveolari pulmonarja [2 pazjenti]).
English: Contraception
Maltese: Kontraċettiv
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Days 1, 4, and 7
Maltese: 3 mg/m2/doża (sa massimu ta' kunjett wieħed ta' 5 mg) f'Jiem 1, 4 u 7
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC05
Maltese: Mediċini neoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: During the consolidation 2 phase, 80 (97.6%) and 70 (85.4%) patients had a platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Maltese: Waqt il-fażi ta' konsolidazzjoni 2, 80 (97.6%) u 70 (85.4%) pazjent kellhom irkupru tal-plejtlits għal għadd ta' 50,000/mm 3 u 100,000/mm rispettivament.
English: d. 2-sided p-value from the log-rank test. e. Response defined as CR+CRp.
Maltese: Rispons definit bħala CR+CRp.
English: Pharmacokinetics in specific groups of subjects or patients
Maltese: Farmakokinetika fi gruppi speċifiċi ta' individwi jew pazjenti
English: 200 mg/m2/day on Day 1 to Day 7
Maltese: 200 mg/m2/jum f'Jum 1 sa Jum 7
English: Safety information on myelosuppression, infections, VOD overall and VOD post-HSCT, and death, which are known adverse events for MYLOTARG (see section 4.8 and Table 7), was obtained from literature.
Maltese: Informazzjoni tas-sigurtà dwar majelosoppressjoni, infezzjonijiet, VOD globali u VOD wara HSCT, u mewt, li huma avvenimenti avversi magħrufa ta' MYLOTARG (ara sezzjoni 4.8 u Tabella 7), inkisbet mil-letteratura.
English: Effect on drug transporter substrates
Maltese: Effett fuq sottostrati ta' trasportaturi tal-mediċini
English: a. Infection includes Sepsis and Bacteraemia (53.4%), Fungal infection (15.3%), Lower respiratory tract infection
Maltese: Infezzjoni tinkludi Sepsis u Batteremija (53.4%), Infezzjoni fungali (15.
English: No adjustment of the starting dose is required in patients with hepatic impairment defined by total bilirubin ≤ 2 × upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT)
Maltese: Mhu meħtieġ l-ebda aġġustament fid-doża tal-bidu f'pazjenti b'indeboliment tal-fwied definit millbilirubina totali ≤ 2 × limitu ta' fuq tan-normal (ULN) u aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN.
English: Efficacy results from study ALFA-0701 (mITT population)
Maltese: Riżultati tal-effikaċja mill-istudju ALFA-0701 (popolazzjoni mITT)
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.
Maltese: Żid is-soluzzjoni rikostitwita ta' MYLOTARG f'siringa b'soluzzjoni ta' sodium chloride ta' 9 mg/mL (0.9%) għall-injezzjoni għal konċentrazzjoni finali bejn 0.075 mg/mL sa 0.234 mg/mL.
English: How to store MYLOTARG 6.
Maltese: Kif taħżen MYLOTARG 6.
English: During the consolidation 1 phase, 92 (94.8%) and 71 (73.2%) patients had a platelet recovery to counts of 50,000/mm3 and 100,000/mm3, respectively.
Maltese: Waqt il-fażi ta' konsolidazzjoni 1, 92 (94.8%) u 71 (73.2%) pazjent kellhom irkupru tal-plejtlits għal għadd ta' 50,000/mm 100,000/mm 3, rispettivament.
English: • Organ failure
Maltese: • Insuffiċjenza tal-organi
English: In monotherapy studies, clinically relevant serious adverse reactions also included infusion related reactions (2.5%), thrombocytopenia (21.7%), and neutropenia (34.3%).
Maltese: Fi studji ta' monoterapija, reazzjonijiet avversi serji klinikament rilevanti inkludew ukoll reazzjonijiet relatati mal-infużjoni (2.5%), tromboċitopenija (21.7%), u newtropenija
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.
Maltese: B'mod globali, l-età medjana tal-pazjenti kienet 62 sena (medda 50 sa 70 sena) u ħafna mill-pazjenti (87.8%) kellhom status ta' prestazzjoni tal-Grupp tal-Onkoloġija Kooperattiv tal-Lvant (ECOG PS, Eastern Cooperative Oncology Group performance status) ta' 0 sa 1 fil-linja bażi.
English: • MYLOTARG contains no bacteriostatic preservatives.
Maltese: • MYLOTARG ma fih l-ebda preservattiv batterjostatiku.
English: • Infections (including serious infections)
Maltese: • Infezzjonijiet (inkluż infezzjonijiet serji)
English: • Postpone start of consolidation course.
Maltese: • Ipposponi l-bidu tal-kors ta' konsolidazzjoni.
English: Supraventricular tachycardia#.
Maltese: #, u Takikardija supraventrikulari k.
English: In clinical studies, TLS was reported (see section 4.8).
Maltese: Fl-istudji kliniċi, ġie rrappurtat TLS (ara sezzjoni 4.8).
English: In monotherapy studies the most common adverse reactions (> 30%) included pyrexia, nausea, infection, chills, haemorrhage, vomiting, thrombocytopenia, fatigue, headache, stomatitis, diarrhoea, abdominal pain, and neutropenia.
Maltese: Fi studji ta' monoterapija, ir-reazzjonijiet avversi l-aktar komuni (> 30%) inkludew deni, nawsja, infezzjoni, dehxiet ta' bard, emorraġija, rimettar, tromboċitopenija, għeja, uġigħ ta' ras, stomatite, dijarea, uġigħ addominali u newtropenija.
English: In clinical studies infusion related reactions, including anaphylaxis were reported (see section 4.8).
Maltese: Fi studji kliniċi, ġew irrappurtati reazzjonijiet relatati mal-infużjoni, inkluż anafilassi (ara sezzjoni 4.8).
English: MYLOTARG contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża.
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).
Maltese: Abbażi tal-analiżi PK tal-popolazzjoni f'406 pazjent, it-tneħħija ta' gemtuzumab ozogamicin f'pazjenti b'indeboliment tal-kliewi ħafif (tneħħija tal-kreatinina [CLcr] 60-89 mL/min; n=149) jew b'indeboliment tal-kliewi moderat (CLcr 30-59 mL/min; n=47), kienet simili għal pazjenti b'funzjoni tal-kliewi normali (CLcr ≥ 90 mL/min; n=209).
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.
Maltese: MYLOTARG ingħata bħala monoterapija f'47.1%, parti minn kombinazzjoni fi 23.5%, u fiż-żewġ kuntesti f'29.
English: 60 mg/m2/day on Day 3 to Day 5
Maltese: 60 mg/m2/jum f'Jum 3 sa Jum 5
English: Patients with acute promyelocytic leukaemia (APL, AML3) and patients with AML arising from myelodysplastic syndrome (MDS) or secondary AML were excluded from the study.
Maltese: Pazjenti b'lewkimja promajeloċitika akuta (APL, AML3) u pazjenti b'AML li tirriżulta minn sindrome majelodisplastiku (MDS, myelodysplastic syndrome) jew AML sekondarja ġew esklużi mill-istudju.
English: In clinical studies, neutropenia, thrombocytopenia, anaemia, leukopenia, febrile neutropenia, lymphopenia, and pancytopenia, some of which were life-threatening or fatal, were reported (see section 4.8).
Maltese: Fl-istudji kliniċi ġew irrappurtati newtropenija, tromboċtipenija, anemija, lewkopenija, newtropenija bid-deni, limfopenija, u panċitopenija, li xi wħud minnhom kienu ta' periklu għall-ħajja jew fatali (ara sezzjoni 4.8).
English: The most common adverse reactions (> 30%) in the combination therapy study were haemorrhage and infection.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni (> 30%) fl-istudju ta' terapija kombinata kienu emorraġija u infezzjoni.
English: Fractionatedb MYLO TARG
Maltese: Kif taħżen MYLOTARG
English: MYLOTARG 5 mg powder for concentrate for solution for infusion gemtuzumab ozogamicin
Maltese: MYLOTARG 5 mg trab għal konċentrat gemtuzumab ozogamicin
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjoni 4.8, 5.1 u 5.2 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
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.
Maltese: MYLOTARG (doża totali li tvarja bejn 1.8 mg/m2 - 9 mg/m2) darbtejn matul iċ-ċiklu mill-inqas b'intervall ta' 14-il jum.
English: Leukopeniae
Maltese: Pożoloġija
English: k. Haemorrhages include Central nervous system haemorrhage (5.1%), Upper gastrointestinal haemorrhage (21.3%),
Maltese: Emorraġiji tinkludi Emorraġija tas-sistema nervuża ċentrali (5.1%), Emorraġija gastrointestinali ta' fuq (21.3%), Emorraġija gastrointestinali t'isfel (15.
English: Persistent thrombocytopenia (Platelets < 100,000/mm3 at the planned start date of the consolidation course)
Maltese: Tromboċitopenija persistenti (Plejtlits < 100,000/mm
English: • Excessive accumulation of fluid in the abdomen/stomach
Maltese: • Akkumulazzjoni eċċessiva ta' fluwidu fiż-żaqq/stonku
English: Fatal severe infection was reported in 2 (1.53%) patients in the MYLOTARG arm and 4 (2.92%) patients in the control arm.
Maltese: Infezzjoni severa fatali ġiet irrappurtata f'2 (1.53%) pazjenti fil-fergħa ta' MYLOTARG u f'4 (2.92%) pazjenti fil-fergħa talkontroll.
English: u. Rash includes the following reported PTs: Rash, Dermatitis#, Dermatitis allergic#, Dermatitis bullous, Dermatitis contact, Dermatitis exfoliative#, Drug eruption, Pruritus allergic# and Rash erythematous#, Rash macular#, Rash maculo papular, Rash papular, Rash pruritic, Rash vesicular#.
Maltese: Raxx, Dermatite #, Dermatite allerġika #, Dermatite bulluża, Dermatite tal kuntatt, Dermatite esfoljattiva #, Eruzzjoni tal-mediċina, Prurite allerġiku
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.
Maltese: MYLOTARG fih is-sustanza attiva gemtuzumab ozogamicin, mediċina kontra l-kanċer, li hija magħmula minn antikorp monoklonali marbut ma' sustanza intenzjonata biex toqtol iċ-ċelluli talkanċer.
English: Each vial contains 5 mg of gemtuzumab ozogamicin.
Maltese: Kull kunjett fih 5 mg gemtuzumab ozogamicin.
English: Renal impairment
Maltese: Mhux irrappurtati
English: The small molecule, N-acetyl gamma calicheamicin, is a cytotoxic semisynthetic natural product.
Maltese: Il-molekula ż-żgħira, N-acetyl gamma calicheamicin, hija prodott ċitotossiku.
English: When gemtuzumab ozogamicin is administered at 3 mg/m2 on Days 1, 4, and 7, the Cmax of hP67.6, which would occur at the end of infusion, is predicted to be 0.38 mg/L following the first dose and increased to 0.63 mg/L after the third dose.
Maltese: Meta gemtuzumab ozogamicin jingħata f'doża ta' 3 mg/m2 f'Jiem 1, 4 u 7, is-Cmax ta' hP67.6, li sseħħ fl-aħħar tal-infużjoni, hija mbassra li tkun 0.38 mg/L wara l-ewwel doża u żdiedet għal 0.63 mg/L wara t-tielet doża.
English: (Cyprus Branch)
Maltese: Pfizer Ελλάς Α.Ε. (Cyprus Branch)
English: • The other ingredients are dextran 40, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous.
Maltese: • Is-sustanzi mhux attivi l-oħra huma dextran 40, sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous
English: Hepatomegaly Jaundice
Maltese: Il-gradi kollha
English: Other medicines and MYLOTARG
Maltese: Mediċini oħra u MYLOTARG
English: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide and gemtuzumab ozogamicin had a low potential to induce the activities of CYP1A2, CYP2B6, and CYP3A4 at clinically relevant concentrations.
Maltese: In vitro, N-acetyl gamma calicheamicin dimethyl hydrazide u gemtuzumab ozogamicin kellhom potenzjal baxx li jinduċu l-attivitajiet ta' CYP1A2, CYP2B6, u CYP3A4 b'konċentrazzjonijiet klinikament rilevanti.
English: Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of CD33-directed monoclonal antibody (hP67.6) that is covalently linked to the cytotoxic agent N-acetyl-gamma calicheamicin.
Maltese: Gemtuzumab ozogamicin huwa konjugat ta' mediċina tal-antikorpi (ADC) magħmul minn antikorp monoklonali dirett lejn CD33 (hP67.6) li huwa marbut b'mod kovalenti mal-aġent ċitotossiku Nacetyl-gamma calicheamicin.
English: m. Hypertension includes the following reported PTs: Hypertension and Blood pressure increased.
Maltese: Anemija tinkludi l-PTs irrappurtati li ġejjin: Anemija u Tnaqqis fl-emoglobina.
English: Frequency unknown (frequency cannot be estimated from the available data):
Maltese: Frekwenza mhux magħruf (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli):
English: MYLOTARG should not be administered as an intravenous push or bolus (see section 6.6).
Maltese: MYLOTARG m'għandux jingħata bħala push ġol-vini jew bolus (ara sezzjoni 6.6).
English: If not used immediately, store at room temperature (below 25°C) for up to 6 hours.
Maltese: Jekk ma jintużax immedjatament, aħżen f'temperatura ambjentali (taħt 25C) sa 6 sigħat.
English: Management of some adverse reactions may require dose interruptions or permanent discontinuation of MYLOTARG (see sections 4.4 and 4.8).
Maltese: Il-ġestjoni ta' xi reazzjonijiet avversi tal-mediċina tista' tkun teħtieġ interruzzjonijiet fid-doża jew twaqqif permanenti ta' MYLOTARG (ara sezzjonijiet 4.4 u 4.8).
English: The most frequent Grade 3 bleeding/haemorrhagic reactions were epistaxis (1.5%), haemoptysis (3.1%), and haematuria (2.3%).
Maltese: Irreazzjonijiet ta' ħruġ ta' demm/emorraġiċi ta' Grad 3 l-aktar frekwenti kienu epistassi (1.5%), emoptiżi (3.1%), u ematurja (2.3%).
English: 3 mg/m2/dose (up to a maximum of one 5 mg vial) on Day 1
Maltese: 3 mg/m2/doża (sa massimu ta' kunjett wieħed ta' 5 mg) f'Jum 1
English: See Table 1 for dose recommendations for consolidation course.
Maltese: Ara Tabella 1 għal rakkomandazzjonijiet dwar id-doża għal kors ta' konsolidazzjoni.
English: It is essentially ‘sodium-free'.
Maltese: Din hija essenzjalment “ħielsa mis-sodium”.
English: The trial met its primary objective of demonstrating that MYLOTARG added in fractionated doses (3 mg/m2 × 3) to standard induction chemotherapy for patients with previously untreated de novo AML resulted in a statistically significant and clinically meaningful improvement in EFS.
Maltese: Il-prova ssodisfat l-objettiv primarju tagħha billi wriet li MYLOTARG miżjud f'dożi frazzjonati (3 mg/m2 × 3) mal-kimoterapija ta' induzzjoni standard għal pazjenti b'AML de novo li ma ġietx ikkurata preċedentement irriżulta f'titjib statistikament sinfikanti u klinikament sinifikanti fl-EFS.
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.
Maltese: Il-farmakokinetika (PK) ta' gemtuzumab ozogamicin hija deskritta billi jitkejlu l-karatteristiċi tal-PK tal-antikorp (hP67.6) kif ukoll id-derivattivi ta' calicheamicin totali u mhux konjugati.
English: • Each vial contains 5 mg gemtuzumab ozogamicin.
Maltese: • Kull kunjett fih 5 mg gemtuzumab ozogamicin.
English: The median times to platelet recovery to counts of 50,000/mm3 and 100,000/mm3 were 36.5 and 43 days, respectively.
Maltese: Iż-żmien medjan għal irkupru tal-plejtlits għal għadd ta' 50,000/mm 3 u 100,000/mm kien 36.5 u 43 jum, rispettivament.
English: Abbreviations: AML=acute myeloid leukaemia; AraC=cytarabine; BMA=bone marrow aspirate, DNR=daunorubicin.
Maltese: BMA=aspirat tal-mudullun, DNR=daunorubicin.
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).
Maltese: B'kollox 271 pazjent ġew magħżula b'mod każwali f'dan l-istudju b'135 għal kura ta' induzzjoni ta' 3+7 DA flimkien ma' dożi ta' 3 mg/m2 × 3 frazzjonati ta' MYLOTARG u 136 sa 3+7 DA waħdu (ara sezzjoni 4.2).
English: 4 studies; N per study (range) 12-84; 42.2%
Maltese: 4 studji; N għal kull studju (firxa) 12-84;
English: When reconstituted to a 1 mg/mL concentration as directed, the extractable content of the vial is 4.5 mg (4.5 mL).
Maltese: Meta jiġi rikostitwit għal konċentrazzjoni ta' 1 mg/mL, il-kontenut li jista' jiġi estratt ta' kunjett wieħed ikun ta' 4.5 mg (4.5 mL).
English: Premedication with a corticosteroid, antihistamine and acetaminophen (or paracetamol) is recommended 1 hour prior to MYLOTARG dosing (see section 4.2).
Maltese: Premedikazzjoni b'kortikosterojd, antistamina, u acetaminophen (jew paracetamol) hija rakkomandata siegħa qabel id-dożaġġ ta' MYLOTARG (ara sezzjoni 4.2).
English: Almost all patients (>90 %) experienced myelosuppression across studies a: When MYLOTARG was given in combination, cytarabine was part of the combination studied in 8 out of the 9 studies.
Maltese: Kważi l-pazjenti kollha (>90 %) esperjenzaw majelosoppressjoni fost l-istudji a: Meta MYLOTARG ingħata f'kombinazzjoni, cytarabine kien parti mill-kombinazzjoni studjata fi 8 minn 9 studji.
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.
Maltese: Il-profil tas-sigurtà globali ta' MYLOTARG huwa bbażat fuq dejta minn pazjenti b'lewkimja majelojde akuta mill-istudju ta' terapija kombinata ALFA-0701, studji ta' monoterapija u minn esperjenza ta' wara t-tqegħid fis-suq.
English: MYLOTARG was given as induction treatment in most studies (82.4%).
Maltese: induzzjoni fil-maġġoranza tal-istudji (82.4%).
English: fungal lung infections including Pulmonary mycosis and Pneumocystis jirovecii pneumonia*; and bacterial infections including Stenotrophomonas infection were also reported.
Maltese: *; u infezzjonijiet batteriċi inkluż Infezzjoni stenotrophomonas ukoll ġew irrappurtati.
English: However, it was also found that increased toxicity (post-remission toxic mortality) was observed in patients with low-risk AML which was attributed to the prolonged neutropenia that occurred after receiving gemtuzumab ozogamicin during intensification Course 2 (see sections 4.2 and 4.8).
Maltese: Madankollu, instab ukoll li ġiet osservata żieda fl-effett tossiku (mortalità tossika wara r-remissjoni) f'pazjenti b'AML ta' riskju baxx li ġiet attribwita għannewtropenija mdewma li seħħet wara li dawn irċivew gemtuzumab ozogamicin waqt Kors 2 ta' intensifikazzjoni (ara sezzjonijiet 4.2 u 4.8).
English: Gastrointestinal disorders Very common Vomiting
Maltese: Pulmonite interstizjali Disturbi gastrointestinali Komuni ħafna
English: Increased embryolethality and foetal morphological anomalies included digital malformations, absence of the aortic arch, anomalies in the long bones in the forelimbs, misshapen scapula, absence of a vertebral centrum, and fused sternebrae.
Maltese: Żieda fl-embrijoletalità u fl-anomaliji morfoloġiċi tal-fetu inkludew malformazzjonijiet diġitali, nuqqas tal-arka aortika, anomaliji fl-għadam twil fis-saqajn ta' quddiem, skapula deformata, nuqqas ta' ċentrum vertebrali u sternebrae magħqudin ma' xulxin.
English: • Doses administered by syringe must utilize small bore infusion lines (microbore) with an in-line, low protein-binding 0.2 micron polyethersulphone (PES) filter.
Maltese: • Id-dożi mogħtija bis-siringa għandhom jutilizzaw linji ta' infużjoni ta' toqob żgħar (microbore) b'filtru f'linja, bi twaħħil baxx mal-proteini ta' 0.2 mikron tal-polyethersulphone (PES).
English: Determination of PK parameters for unconjugated calicheamicin was limited due to the low systemic concentration levels.
Maltese: Id-determinazzjoni għall-parametri tal-PK għal calicheamicin mhux konjugat kienet limitata minħabba l-livelli ta' konċentrazzjoni sistemika baxxi.