FrancophonIA/ELRC3.0 huggingface dataset:
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq il-preparazzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: 59 days
Maltese: 59 ġurnata
English: 32 days
Maltese: 32 ġurnata
English: Gastrointestinal disorders Diarrhoea
Maltese: Disturbi gastro-intestinali
English: In vitro enzymatic studies with human liver microsomes revealed that arsenic trioxide has no inhibitory activity on substrates of the major cytochrome P450 enzymes such as 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, 3A4/5, 4A9/11.
Maltese: Studji in vitro bl-enzimi b'mikrosomi tal-fwied tal-bnedmin urew li arsenic trioxide m'għandu l-ebda attività inibitorja fuq substrati ta' l-enzimi maġġuri taċ-ċitokromju P450 bħal 1A2, 2A6, 2B6, 2C8,
English: Patients with newly diagnosed APL confirmed by the presence of t(15; 17) or PML-RARα by RT-PCR or micro speckled PML nuclear distribution in leukaemic cells were included.
Maltese: Kienu inklużi pazjenti b'APL iddijanjostikata għall-ewwel darba kkonfermata bil-preżenza ta' t(15; 17) jew PML-RARα b'RT-PCR jew distribuzzjoni nukleari ta' micro speckled PML fiċ-ċelluli lewkemiċi.
English: Arsenic trioxide causes morphological changes and deoxyribonucleic acid (DNA) fragmentation characteristic of apoptosis in NB4 human promyelocytic leukaemia cells in vitro.
Maltese: Arsenic trioxide jikkawża tibdil morfoloġikali u fragmentazzjoni ta' deoxyribonucleic acid (DNA) li huma karatteristika ta'
English: One patient (receiving multiple, concomitant medicinal products, including amphotericin B) had asymptomatic torsade de pointes during induction therapy for relapsed APL with arsenic trioxide.
Maltese: Pazjent (li rċieva prodotti mediċinali multipliċi, konkomitanti, inklużi amphotericin B) kellha torsade de pointes asimptomatiku matul it-terapija ta' l-induzzjoni għall-APL
English: In newly diagnosed APL patients treated with arsenic trioxide and all-trans-retinoic acid (ATRA), APL differentiation syndrome was observed in 19 % including 5 severe cases.
Maltese: F'pazjenti b'APL iddijanjostikata għall-ewwel darba ttrattati b'arsenic trioxide u all-trans-retinoic acid (ATRA), kien osservat sindrome ta' divrenzjar ta' APL f'19% inklużi
English: In a phase 3, multicentre, non-inferiority trial comparing all-trans-retinoic acid (ATRA) plus chemotherapy with ATRA plus arsenic trioxide in newly diagnosed low-to-intermediate risk APL patients (Study APL0406; see also section 5.1), serious adverse reactions including hepatic toxicity, thrombocytopenia, neutropenia and QTc prolongation were observed in patients treated with arsenic trioxide.
Maltese: Fil-prova ta 'noninferjorità u multiċentrika ta 'fażi 3, li qabblet alltransretinoic acid (ATRA) flimkien ma 'kimoterapija ma 'ATRA flimkien ma 'arsenic trioxide f'pazjenti b'APL iddijanjostikati għallewwel darba b'riskju baxx sa intermedju (studju APL0406; ara wkoll sezzjoni 5.1), reazzjonijiet avversi serji li jinkludu tossiċità epatika, tromboċitopenija, newtropenija u titwil fil-QTc, ġew osservati f'pazjenti kkurati b'arsenic trioxide.
English: TRISENOX is indicated for induction of remission, and consolidation in adult patients with:
Maltese: TRISENOX hu indikat għall-induzzjoni tar-remissjoni, u l-konsolidazzjoni f'pazjent adulti li jbatu minn:
English: Mortality in the pivotal studies in the relapsed setting from disseminated intravascular coagulation (DIC) associated haemorrhage was very common (> 10 %), which is consistent with the early mortality reported in the literature.
Maltese: Il-mortalità fi studji pivotali f'ambjent ta' rkadar minn ememorraġija assoċjata ma' koagulazzjoni intravaskulari mifruxa (DIC) kienet komuni ħafna (>10%), li hi konsistenti ma' mortalità bikrija rrapportata fil-literattura.
English: Patients in the ATRA + TRISENOX treatment group received oral ATRA at 45 mg/m2 daily and IV
Maltese: Pazjenti fil-grupp ta' trattament b'ATRA+ TRISENOX irċevew 45 mg/m2 ATRA orali kuljum u 0.15 mg/kg
English: For storage conditions after dilution of the medicinal products, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodotti mediċinali, ara sezzjoni 6.3. 6.5
English: Each course of consolidation was initiated at haematological recovery from the previous course defined as absolute neutrophil count > 1.5 × 109/l and platelets > 100 × 109/l.
Maltese: newtrofili ta' >1.5×109/L u plejtlits ta' >100×109/L.
English: • cisapride (a medicine used to relieve certain stomach problems).
Maltese: • cisapride (mediċina wżata biex tikkura ċertu problemi fl-istonku).
English: Time to CR (median)
Maltese: Żmien għal RK (medjan)
English: Pleuritic pain
Maltese: Popolazzjoni pedjatrika
English: In newly diagnosed APL patients 15.6 % showed QTc prolongation with arsenic trioxide in combination with ATRA (see section 4.8).
Maltese: F'pazjenti b'APL iddijanjostikata għall-ewwel darba 15.6% kellhom titwil tal-QTc b'arsenic trioxide flimkien ma' ATRA (ara sezzjoni 4.8).
English: Patients in the ATRA + chemotherapy treatment group received IV idarubicin at 12 mg/m2 on days 2, 4, 6, and 8 and oral ATRA at 45 mg/m2 daily until CR. During consolidation, patients received idarubicin at 5 mg/m2 on days 1 to 4 and ATRA at 45 mg/m2 daily for 15 days, then IV mitoxantrone at 10 mg/m2 on days 1
Maltese: Matul il-konsolidazzjoni, il-pazjenti rċevew 5 mg/m2 idarubicin fil-jiem 1 sa 4 u 45 mg/m2 ATRA kuljum għal 15-il jum, imbagħad 10 mg/m2 mitoxantrone IV fil-jiem 1 sa 5 u għal darb'oħra 45 mg/m2 ATRA kuljum għal 15-il jum, u fl-aħħar doża waħda ta' 12 mg/m2 idarubicin u 45 mg/m2 ATRA kuljum għal 15-il jum.
English: In newly diagnosed patients with low to intermediate risk APL, differentiation syndrome was observed in 19 % including 5 severe cases.
Maltese: F'pazjenti ddijanjostikati għall-ewwel darba b'APL ta' riskju baxx sa intermedju, kien osservat sindrome ta' divrenzjar f'19% inklużi 5 każijiet severi.
English: The pentavalent metabolites, MMAV and DMAV, are slow to appear in plasma (approximately 10-24 hours after first administration of arsenic trioxide), but due to their longer half-life, accumulate more upon multiple dosing than does AsIII.
Maltese: Il-metaboliti pentavalenti, MMAV u DMAV, huma osservati bil-mod fil-plażma (madwar 10-24 siegħa wara l-ewwel għoti ta' arsenic trioxide), iżda minħabba l-half-life itwal tagħhom, jakkumulaw aktar wara dożaġġ multiplu minn AsIII.
English: The safety and efficacy of TRISENOX in children aged up to 17 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' TRISENOX fit-tfal ta' età sa 17-il sena għadhom ma ġewx determinati s'issa.
English: Patients with complete remission received consolidation therapy with TRISENOX for 25 additional doses over a 5 week period.
Maltese: Pażjenti li kellhom rimessjoni kompleta, ngħataw terapija ta' konsolidazzjoni b'TRISENOX għal 25 doża addizzjonali fuq firxa ta' perijodu ta' 5 ġimgħat.
English: Renal impairment Plasma clearance of AsIII was not altered in patients with mild renal impairment (creatinine clearance of 50-80 ml/min) or moderate renal impairment (creatinine clearance of 30-49 ml/min).
Maltese: It-tneħħija mill-plażma ta' AsIII ma kienetx mibdula f'pazjenti b'indeboliment renali ħafif (tneħħija tal-krejatinina ta' 50-80 mL/min) jew b'indeboliment renali moderat (tneħħija tal-krejatinina ta' 30-49 mL/min).
English: Hydrochloric acid (for pH adjustment) Water for injections
Maltese: Hydrochloric acid (għall-aġġustament tal-pH)
English: Related adverse reactions of CTC grade 3 and 4 occurred in 37 % of relapsed/refractory APL patients in clinical trials.
Maltese: Sommarju tal-profil tas-sigurtà Reazzjonijiet avversi relatati ta' Grad 3 u 4 CTC seħħu fi 37% tal-pazjenti b'APL li tirkadi/refrattarja fi studji kliniċi f'pazjenti b'APL.
English: Very Common
Maltese: Komuni Komuni
English: Erythema
Maltese: Wernicke
English: Chills
Maltese: Nawseja
English: APL = acute promyelocytic leukaemia; ATRA = all-trans-retinoic acid
Maltese: flimkien ma' all-trans-retinoic acid (ATRA)
English: CAUTION, NOTICE NEW CONCENTRATION (2 mg/ml)
Maltese: ATTENZJONI, INNOTA IL-KONĊENTRAZZJONI L-ĠDIDA (2 mg/mL)
English: TRISENOX must be diluted with 100 to 250 ml of glucose 50 mg/ml (5 %) solution for injection or sodium chloride 9 mg/ml (0.9 %) solution for injection immediately after withdrawal from the ampoule or vial.
Maltese: TRISENOX irid ikun dilwit ma' 100 sa 250 mL ta' 50 mg/mL (5%) glucose soluzzjoni għall injezzjoni jew soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride hekk kif jinġibed mill ampulla jew mill-kunjett.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: In one newly diagnosed patient induction treatment was terminated because of severe prolongation of the QTc interval and electrolyte abnormalities on day 3 of induction treatment.
Maltese: F'pazjent wieħed it-trattament ta' induzzjoni twaqqaf minħabba titwil sever tal intervall QTc u anormalitajiet tal-elettroliti f'jum 3.
English: The total clearance of AsIII over the single-dose range of 7-32 mg (administered as 0.15 mg/kg) is 49 l/h and the renal clearance is 9 l/h.
Maltese: fuq il-firxa ta' doża waħda ta' 7-32 mg (mogħti bħala 0.15 mg/kg) hija 49 L/h u t-tneħħija renali hija 9 L/h.
English: Patients in the multicentre study had relapsed following 1-4 prior therapy regimens and 5 patients had relapsed following stem cell transplantation.
Maltese: Pazjenti fl-istudju multiċentriku kellhom rikaduta wara 1-4 ir-reġimeni ta' terapija ta' qabel u 5 pazjenti kellhom rikaduta wara ttrapjant taċ-ċelluli staminali.
English: Approximate accumulation ranged from 1.4- to 8-fold following multiple as compared to single dose administration.
Maltese: L-akkumulazzjoni approssimattiva varjat minn 1.4 sa 8 darbiet wara għoti ta'
English: WBC counts during consolidation were not as high as during induction treatment and were < 10 x 103/μl, except in one patient who had a WBC count of 22 x 103/μl during consolidation.
Maltese: Il-kownts tal-WBC matul il-konsolidazzjoni ma kinux għoljin daqshekk matul it-trattament ta' l-induzzjoni u kienu <10 x 103/μL, barra fil-każ ta' pazjent wieħed li kellu kownt ta' WBC ta' 22 x 103/μL matul il konsolidazzjoni.
English: Leukocyte activation syndrome (APL differentiation syndrome) 27 % of patients with APL, in the relapsed/refractory setting, treated with arsenic trioxide have experienced symptoms similar to a syndrome called the retinoic-acid-acute promyelocytic leukaemia (RA-APL) or APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leucocytosis.
Maltese: Sindrome ta' attivazzjoni tal-lewkoċiti (sindrome ta' divrenzjar ta' APL) 27% tal-pazjenti b'APL, f'ambjent ta' rkadar/refrattarju, li kienu kkurati b'arsenic trioxide kellhom sintomi simili għas-sindrome magħruf bħala lewkimja promijeloċitika akuta-aċida-retinojka (RAAPL) jew sindrome ta' divrenzjar ta' APL, kkaraterizzat minn deni, qtugħ ta' nifs, żjieda fil-piż, infiltrati pulmonari u effużjonijiet plewrali jew perikardjali, ma' jew mingħajr il-lewkoċiti.
English: Patients with risk factors of QTc prolongation or risk factors of torsade de pointes should be monitored with continuous cardiac monitoring (ECG).
Maltese: Pazjenti li għandhom fatturi ta' riskju ta' titwil ta' QTc jew fatturi ta' riskju ta' torsade de pointes iridu jkunu monitorjati b'monitoraġġ kontinwu kardijaku (ECG).
English: The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products (such as class Ia and III antiarrythmics (e.g. quinidine, amiodarone, sotalol, dofetilide), antipsychotics (e.g. thioridazine), antidepressants (e.g. amitriptyline), some macrolides (e.g. erythromycin), some antihistamines (e.g. terfenadine and astemizole), some quinolone antibiotics (e.g. sparfloxacin), and other individual medicinal products known to increase QT interval (e.g. cisapride)), a history of torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, amphotericin B or other conditions that result in hypokalaemia or hypomagnesaemia.
Maltese: Ir riskju tat-torsade de pointes hu marbut ma' kemm ikun it-titwil tal-QT, l-għoti konkomitanti tal prodotti mediċinali li jtawwlu l-QT (bħal ngħidu aħna antjarrimiċi tal-klassi Ia u III (eż. quinidine, amiodarone, sotalol, dofetilide), antipsikotiċi (eż. thioridazine), antidipressanti (eż. amitriptyline), xi macrolides (eż. erythromycin), xi antistamini (eż. terfenadine u astemizole), xi antibijotiċi quinolone
English: Pain
Maltese: BŻONN
English: Each ml of concentrate contains 2 mg of arsenic trioxide.
Maltese: Kull mL ta' konċentrat fih 2 mg ta' arsenic trioxide.
English: Hepatotoxicity (grade 3 or greater)
Maltese: Epatotossiċità (grad 3 jew akbar)
English: 2-Year overall survival (OS)
Maltese: Sopravivenza globali (OS - overall survival) ta' sentejn p=0.02
English: Respiratory, thoracic and mediastinal disorders Differentiation syndrome
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: The median age in the single centre study was 33 years (age range 9 to 75).
Maltese: L-età medjana fl-istudju ċentriku uniku kienet 33 sena (firxa ta' l-età minn 9 sa 75).
English: TRISENOX 1 mg/ml concentrate for solution for infusion arsenic trioxide
Maltese: TRISENOX 1 mg/mL konċentrat sterili arsenic trioxide
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX27
Maltese: Aġenti antineoplastiċi oħra, Kodiċi ATC:
English: Patients in the ATRA + chemotherapy treatment group also received maintenance treatment for up to 2 years, consisting of oral 6-mercaptopurine at 50 mg/m2 daily, intramuscular methotrexate at 15 mg/m2 weekly, and ATRA at 45 mg/m2 daily for 15 days every
Maltese: Pazjenti fil-grupp ta' trattament b'ATRA+kimoterapija rċevew ukoll trattament ta' manutenzjoni għal perjodu sa sentejn, li kien jikkonsisti minn 50 mg/m2 ta' 6-mercaptopurine orali kuljum, 15 mg/m2 methotrexate intramaskulari fil-ġimgħa, u 45 mg/m2 ATRA kuljum għal 15-il jum kull 3 xhur.
English: Leucocytosis
Maltese: Citotossiku
English: - fatigue (weariness), pain, fever, headache
Maltese: - infezzjoni fil-pulmun, infezzjoni fid-demm
English: Patients in the first study received a median dose of 0.16 mg/kg/day of TRISENOX (range 0.06 to 0.20 mg/kg/day) and patients in the multicentre study received a fixed dose of 0.15 mg/kg/day.
Maltese: Pazjenti ta' l-ewwel studju ngħataw doża medjana ta' 0.16 mg/kg/kuljum ta' TRISENOX ( bejn 0.06 sa 0.20 mg/kg/kuljum) u pazjenti fl-istudji multiċentriku ngħataw doża fissa ta' 0.15 mg/kg/kuljum.
English: Each ml of concentrate contains 1 mg of arsenic trioxide.
Maltese: Kull mL ta' konċentrat fih 1 mg ta' arsenic trioxide.
English: TRISENOX has been investigated in 52 APL patients, previously treated with an anthracycline and a retinoid regimen, in two open-label, single-arm, non-comparative studies.
Maltese: retinoid, f'żewġ studji open-label, single-arm, mhux komparattivi.
English: Of 7 patients under 18 years of age (range 5 to 16 years) treated with TRISENOX at the recommended dose of 0.15 mg/kg/day, 5 patients achieved a complete response (see section 4.2).
Maltese: Mis-7 pazjenti li għadhom m'għalqux 18-il sena (medda minn 5 sa 16il sena) ikkurati bi TRISENOX fid-doża rakkomandata ta' 0.15 mg/kg/jum, 5 pazjenti kisbu rispons sħiħ (ara sezzjoni 4.2).
English: p = 0.24
Maltese: KR=34
English: Blood and lymphatic system disorders Febrile neutropenia
Maltese: Disturbi fis-sistema nervuża
English: Use of TRISENOX
Maltese: TRISENOX.
English: Present
Maltese: LISTA
English: The plasma concentration of AsIII declines from peak plasma concentration in a biphasic manner with a mean terminal elimination half-life of 10 to 14 hours.
Maltese: Il konċentrazzjoni fil-plażma ta' AsIII tonqos mill-konċentrazzjoni massima fil-plażma b'mod bifażiku b'half-life medja ta' l-eliminazzjoni terminali ta' 10 sigħat sa 14-il siegħa.
English: In the multicentre study 27 of 40 patients were alive with a median follow-up time of 16 months (range 9 to 25).
Maltese: Fl-istudju multiċentriku 27 minn 40 pazjent kienu ħajjin bi żmien medjan ta' 16-il xahar (firxa ta' minn 9 sa 25).
English: Currently available data for children aged 5 to 16 years are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Data disponibbli għal tfal ta' età minn 5 sa 16-il sena hija deskritta fis-sezzjoni 5.1, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: 2-Year cumulative incidence of relapse (CIR)
Maltese: Inċidenza kumulattiva ta' rkadar (CIRcumulative incidence of relapse) ta' sentejn p=0.24
English: However, arsenic trioxide and other inorganic arsenic compounds are recognised as human carcinogens.
Maltese: Imma, arsenic trioxide u kompownds oħra arseniċi inorganiċi huma meqjusa bħala karkinoġeniċi umani.
English: Table 3 Endpoint
Maltese: ANNESS III
English: Wernicke encephalopathy after arsenic trioxide treatment was reported in patients with vitamin B1 deficiency.
Maltese: Enċefalopatija ta' Wernicke wara trattament b'arsenic trioxide kienet irrappurtata f'pazjenti b'defiċjenza ta'
English: 2-Year disease-free survival (DFS)
Maltese: Sopravivenza mingħajr mard (DFS
English: In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with arsenic trioxide in combination with ATRA (see section 4.8).
Maltese: F'pazjenti ddijanjostikati għall-ewwel darba b'APL ta' riskju baxx sa intermedju, 63.2% żviluppaw effetti ta' tossiċità epatika ta' grad 3 jew 4 matul it-trattament ta' induzzjoni jew konsolidazzjoni b' arsenic trioxide flimkien ma' ATRA (ara sezzjoni 4.8).
English: Twenty-seven patients had leucocytosis (WBC  10 x 103/l) during induction, 4 of whom had values above 100,000/l.
Maltese: Sebgħa u għoxrin pazjent kellhom lewkoċitożi (WBC ≥ 10 x 103/µl) matul l-induzzjoni, 4 minnhom kellhom valuri ogħla minn 100,000/µl.
English: Treatment with arsenic trioxide has been associated with the development of hyperleucocytosis (≥ 10 x 103/μl) in some relapsed/refractory APL patients.
Maltese: It-trattament b'arsenic trioxide kien assoċjat ma' l-iżvilupp ta' iperlewkoċitożi (≥ 10 x 103/μL) f'xi pazjenti b'APL li tirkadi/refrattarja.
English: Prior to initiating therapy with TRISENOX, a 12-lead ECG must be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine must be assessed; pre-existing electrolyte abnormalities must be corrected and, if possible, medicinal products that are known to prolong the QT interval must be discontinued.
Maltese: Rakkomandazzjonijiet dwar il-monitoraġġ tal-ECG u tal-elettroliti Qabel ma tibda tingħata t-terapija b'TRISENOX, irid isir 12-lead ECG u l-elektroliti fis-serum (potassium, calcium, u magnesium) u l-kreatinina jridu jkunu assessjati, abnormalitajiet ta' elektroliti li diġà kienu jeżistu jridu jkunu kkorreġuti u, jekk hu possibbli, prodotti mediċinali li huma magħrufa li jtawlu l-intervall QT iridu jitwaqqfu.
English: The single institution study included 2 paediatric patients (< 18 years old), both of whom achieved CR.
Maltese: Sopravivenza ta' 18-il Xahar L-istudju ta' istituzzjoni unika inkluda 2 pazjenti pedjatriċi (<18-il sena), it-tnejn kellhom RK. L
English: In clinical trials, in the relapsed/refractory setting, 40 % of patients treated with TRISENOX experienced at least one QT corrected (QTc) interval prolongation greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after TRISENOX infusion, and then returned to baseline by the end of 8 weeks after TRISENOX infusion.
Maltese: Fi studji kliniċi, f'ambjent ta' rkadar/refrattarju, 40% talpazjenti li kienu kkurati bit-TRISENOX esperjenzaw ta' l-anqas titwil ta' l-intervall QT kkorreġut (QTc) ta' aktar minn 500 msec.
English: Metabolism and nutrition disorders Hyperglycaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni
English: In newly diagnosed patients with low to intermediate risk APL, gastrointestinal toxicity, grade 3-4 neutropenia and grade 3 or 4 thrombocytopenia occurred, however these were 2.2 times less frequent in patients treated with TRISENOX in combination with ATRA compared to patients treated with ATRA + chemotherapy.
Maltese: F'pazjenti ddijanjostikati għall-ewwel darba, b'APL ta' riskju baxx sa intermedju, seħħew tossiċità gastro-intestinali, newtropenija ta' grad 3-4 u tromboċitopenija ta' grad 3 jew 4, madankollu, dawn 0i kienu 2.2 inqas frekwenti f'pazjenti ttrattati b'TRISENOX flimkien ma' ATRA meta mqabbla ma' pazjenti ttrattati b'ATRA + kimoterapija.
English: In a follow-up treatment after consolidation, 7 patients in the single institution study and 18 patients in the multicentre study received further maintenance therapy with TRISENOX.
Maltese: Fi trattamenti ta' wara il-konsolidazzjoni, 7 pazjenti fl-istudju ta' istituzzjoni unika u 18-il pazjent fl istudju multiċentriku ngħataw aktar terapija ta' manteniment b'TRISENOX.
English: Each vial of 6 ml contains 12 mg of arsenic trioxide.
Maltese: Kull kunjett ta' 6 mL fih 12-il mg ta' arsenic trioxide.
English: However all cases were successfully managed with hydroxyurea therapy.
Maltese: Madankollu, il-każijiet kollha kienu mmaniġġjati b'suċċess b'terapija ta' hydroxyurea.
English: Systemic exposure to MMAV and DMAV tended to be larger in patients with renal impairment; the clinical consequence of this is unknown but no increased toxicity was noted.
Maltese: Esponiment sistemiku għal MMAV u DMAV kellu tendenza li jkun akbar f'pazjenti b'indeboliment renali; il-konsegwenza klinika ta' dan mhux magħrufa iżda ma kienet innutata l-ebda żjieda fittossiċità.
English: Preparation of TRISENOX
Maltese: Preparazzjoni ta' TRISENOX
English: In the presence of coagulopathy, the oral administration of the chelating agent Dimercaptosuccinic Acid Succimer (DCI) 10 mg/kg or 350 mg/m2 every 8 hours during 5 days and then every 12 hours during 2 weeks is recommended.
Maltese: Meta jkun hemm kojagulopatija, l-għoti mill-ħalq ta' aġent ta' kelazzjoni Dimercaptosuccinic Acid Succimer (DCI) 10 mg/kg jew 350 mg/m2 kull 8 sigħat matul 5
English: Cases of encephalopathy were reported with treatment with arsenic trioxide.
Maltese: Każijiet ta' enċefalopatija kienu rrappurtati bi trattament b'arsenic trioxide.
English: In order to prevent the development of the APL differentiation syndrome during induction treatment, prednisone (0.5 mg/kg body weight per day throughout induction treatment) may be administered from day 1 of TRISENOX application to the end of induction therapy in APL patients.
Maltese: Sabiex jiġi evitat l iżvilupp tas-sindrome ta' divrenzjar ta' APL matul it-trattament ta' induzzjoni, prednisone (0.5 mg/kg ta' piż tal-ġisem kuljum matul it-trattament ta' induzzjoni) jista' jingħata minn jum 1 talapplikazzjoni ta' TRISENOX sat-tmiem tat-terapija ta' induzzjoni f'pazjenti b'APL.
English: In newly diagnosed patients with low to intermediate risk APL 63.2 % developed grade 3 or 4 hepatic toxic effects during induction or consolidation treatment with TRISENOX in combination with ATRA.
Maltese: F'pazjenti ddijanjostikati għall-ewwel darba, b'APL ta' riskju baxx sa intermedju 63.2% żviluppaw effetti ta' tossiċità epatika ta' grad 3 jew 4 matul it-trattament ta' induzzjoni jew konsolidazzjoni b'TRISENOX flimkien ma' ATRA.
English: During therapy with TRISENOX, potassium concentrations must be kept above 4 mEq/l and magnesium concentrations must be kept above 1.8 mg/dl.
Maltese: Matul it-terapija b'TRISENOX il-konċentrazzjonijiet tal-potassju jridu jinżammu ogħla minn 4 mEq/L u l-konċentrazzjonijiet tal-magnesium iridu jinżammu ogħla minn 1.8 mg/dl.
English: The multicentre trial included 5 paediatric patients (< 18 years old), 3 of whom achieved CR. No children of less than 5 years of age were treated.
Maltese: istudju multiċentriku inkluda 5 pazjenti pedjatriċi (<18-il sena), 3 minnhom kellhom RK. L-ebda tifel/tifla ta' taħt il-5 snin ma kien ikkurat/a.
English: Ketoacidosis
Maltese: Deidratazzjoni