FrancophonIA/ELRC3.0 huggingface dataset:
English: No formal assessments of pharmacokinetic interactions between arsenic trioxide and other therapeutic medicinal products have been conducted.
Maltese: Ma saru l-ebda assessjamenti formali ta' interazzjonijiet ta' farmakokinetiċi bejn arsenic trioxide u prodotti mediċinali terapewtiċi oħra.
English: Relapsed/refractory acute promyelocytic leukaemia (APL)
Maltese: Lewkimja promijeloċitika akuta (APL) li tirkadi/refrattarja
English: Patients with significant arrhythmias, EKG abnormalities (congenital long QT syndrome, history or presence of significant ventricular or atrial tachyarrhythmia, clinically significant resting bradycardia (<50 beats per minute), QTc > 450 msec on screening EKG, right bundle branch block plus left anterior hemiblock, bifascicular block) or neuropathy were excluded from the study.
Maltese: Pazjenti b'aritmiji sinifikanti, anormalitajiet fl-EKG (sindrome konġenitali ta' QT twil, storja jew preżenza ta' takiarritmija ventrikolari jew atrijali sinifikanti, brakikardija relattiva klinikament sinifikanti (<50 taħbita fil-minuta), QTc >450 millisekonda fl-iskrinjar bl-EKG, bundle branch block tal-lemin u hemiblock anterjuri tax-xellug, bifascicular block) jew newropatija kienu esklużi millistudju.
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 to 5 and ATRA again at 45 mg/m2 daily for 15 days, and finally a single dose of idarubicin at 12 mg/m2 and ATRA at 45 mg/m2 daily for 15 days.
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: Each course of consolidation was initiated at hematological recovery from the previous course defined as absolute neutrophil count >1.5×109/L and platelets >100×109/L.
Maltese: Kull kors ta' konsolidazzjoni nbeda mal-irkupru ematoloġiku mill-kors preċedenti definit bħala għadd assolut ta' newtrofili ta' >1.5×109/L u plejtlits ta' >100×109/L.
English: Arsenic trioxide 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: Arsenic trioxide ġie investigat f'52 pazjent APL, li qabel kienu kkurati bil-anthracycline u reġimen ta' retinoid, f'żewġ studji open-label, single-arm, mhux komparattivi.
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 tal-enzimi maġġuri taċ-ċitokromju P450 bħal 1A2, 2A6, 2B6, 2C8, 2C9,
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) kellu torsade de pointes asimptomatiku matul it-terapija tal-induzzjoni għall-APL rikadut bl-arsenic trioxide.
English: Arsenic trioxide Accord must then be diluted immediately 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.
Maltese: Arsenic trioxide Accord irid imbagħad jiġi dilwit immedjatament b'100 sa 250 mL ta' glucose 50 mg/mL (5%) soluzzjoni għall-injezzjoni jew sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni.
English: Serious adverse reactions were common (1-10%) and not unexpected in the relapsed/refractory population.
Maltese: Reazzjonijiet avversi serji kienu komuni (1-10%) u kienu mistennija fil-popolazzjoni b'irkadar/refrattarja.
English: The median age in the multicentre study was 40 years (age range 5 to 73).
Maltese: L-età medjana fl-istudju multiċentriku kienet 40 sena (firxa tal-età minn 5 sa 73).
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 hypokalemia or hypomagnesaemia.
Maltese: Irriskju tat-torsade de pointes hu marbut ma' kemm ikun it-titwil tal-QT, l-għoti konkomitanti talprodotti 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 (eż. sparfloxacin), u prodotti mediċinali individwali oħra li huma magħrufa li jżidu l-intervall QT (eż. cisapride), passat ta' torsade de pointes, titwil pre-eżistenti tal-intervall QT, insuffiċjenza tal-qalb konġestiva, l-għoti ta' djuretiċi li jnaqqsu l-potassju, amphotericin B jew kondizzjonijiet oħra li jikkaġunaw ipokalimja jew ipomanjesimja.
English: Each carton contains 1, 5 or 10 vials.
Maltese: Kull kartuna fiha 1, 5 jew 10 kunjetti
English: 95 % CI for the difference, 2-22 percentage points p<0.001 for noninferiority p = 0.02 for superiority of ATRA+Arsenic trioxide
Maltese: għaddifferenz a, 2-22 punti perċentw ali p<0.001
English: QT/QTc prolongation is expected during treatment with arsenic trioxide, and Torsade de pointes and complete heart block have been reported.
Maltese: Titwil ta' QT/QTc hu mistenni matul it-trattament b'arsenic trioxide u ġew rrapportati Torsade de pointes u imblokkar komplet tal-qalb.
English: Arsenic trioxide Accord contains sodium
Maltese: Arsenic trioxide Accord fih sodium
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: Of 7 patients less than 18 years of age (range 5 to 16 years) treated with arsenic trioxide 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 għandhom inqas minn 18-il sena (medda minn 5 sa 16-il sena) ikkurati bi arsenic trioxide fid-doża rakkomandata ta' 0.15 mg/kg/jum, 5 pazjenti kisbu rispons sħiħ (ara sezzjoni 4.2).
English: Medicinal products known to cause QT/QTc interval prolongation, hypokalemia or hypomagnesaemia
Maltese: Prodotti mediċinali magħrufa li jikkawżaw titwil tal-intervall QT/QTc, ipokalimja jew ipomanjesimja
English: - The active substance is arsenic trioxide One mL of concentrate contains 1 m arsenic trioxide.One vial contains 10 mg of arsenic trioxide.
Maltese: X'fih Arsenic trioxide Accord - Is-sustanza attiva hi arsenic trioxide. mL wieħed ta' konċentrat fih 1 m arsenic trioxide.
English: Substances that are substrates for these P450 enzymes are not expected to interact with arsenic trioxide.
Maltese: Sustanzi li huma substrati ta' dawn l-enzimi ta' P450 mhux mistennija li jinteraġixxu ma' arsenic trioxide.
English: Patients with complete remission received consolidation therapy with arsenic trioxide for 25 additional doses over a 5 weeks period.
Maltese: Pażjenti li kellhom rimessjoni kompleta, ngħataw terapija ta' konsolidazzjoni b'arsenic trioxide għal 25 doża addizzjonali fuq firxa ta' perijodu ta' 5 ġimgħat.
English: Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion arsenic trioxide
Maltese: Arsenic trioxide Accord 1 mg/mL konċentrat għal soluzzjoni għall-infużjoni arsenic trioxide
English: In a phase 3, multicenter, noninferiority 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: 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' dożi multipli meta mqabbel ma' l-għoti ta' doża waħda.
English: Use of Arsenic trioxide Accord
Maltese: Tużax Arsenic trioxide Accord
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: Patients with newly diagnosed APL confirmed by the presence of t(15; 17) or PML-RAR alpha by RT-PCR or micro speckled PML nuclear distribution in leukemic cells were included.
Maltese: Kienu inklużi pazjenti b'APL iddijanjostikata għall-ewwel darba kkonfermata bil-preżenza ta' t(15; 17) jew PMLRAR alfa b'RT-PCR jew distribuzzjoni nukleari ta' micro speckled PML fiċ-ċelluli lewkemiċi.
English: Undesirable effects are listed in table 2 below as MedDRA preferred term by system organ class and frequencies observed during arsenic trioxide clinical trials in 52 patients with refractory/relapsed
Maltese: L-effetti mhux mixtieqa huma elenkati fit-tabella 2 hawn taħt bħala t-terminu ppreferut tal-MedDRA skont il-klassi tas-sistema tal-organi u l-frekwenzi osservati waqt il-provi kliniċi ta' arsenic trioxide fuq 52 pazjent b'APL/li tirkadi/refrattarja.
English: Hydrochloric acid, concentrated (for pH adjustment) Water for injections
Maltese: Hydrochloric acid, ikkonċentrat (għall-aġġustament tal-pH) Ilma għall-injezzjonijiet
English: Related adverse reactions of CTC grade 3 and 4 occurred in 37% of relapsed/refractory APL patients in clinical trials.
Maltese: CTC seħħu fi 37% tal-pazjenti b'APL li tirkadi/refrattarja fi studji kliniċi f'pazjenti b'APL.
English: In newly diagnosed APL patients 15.6 % showed QTc prolongation with arsenic trioxide in combination with ATRA (see section 4.8).
Maltese: 6% kellhom titwil tal-QTc b'arsenic trioxide flimkien ma' ATRA (ara sezzjoni 4.8).
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 arsenic trioxide.
Maltese: Fi trattamenti ta' wara il-konsolidazzjoni, 7 pazjenti fl-istudju ta' istituzzjoni unika u 18-il pazjent flistudju multiċentriku ngħataw aktar terapija ta' manteniment b'arsenic trioxide.
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: - difficulty in breathing - coughing - chest pain - fever
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Sindrome ta' divrenzjar
English: • any medicines that cause a decrease in magnesium or potassium in your blood (e.g. amphotericin B)
Maltese: • kull mediċina li tikkawża tnaqqis ta' magnesium jew potassium fid-demm tiegħek (eż. amphotericin B)
English: • some medicines to treat allergies such as hayfever, called antihistamines (e.g. terfenadine and astemizole)
Maltese: • xi mediċini għall-kura ta' allerġiji bħal hayfever, imsejħa antistaminiċi (eż. terfenadine u astemizole)
English: Pregnancy
Maltese: Preżenti
English: Arsenic trioxide was administered intravenously over 1 to 2 hours until the bone marrow was free of leukaemic cells, up to a maximum of 60 days.
Maltese: Arsenic trioxide kien mogħti ġol-vina fuq firxa ta' minn 1 sa 2 sagħtejn sakemm il-mudullun tal-għadma kien ħieles miċ-ċelluli lewkemiċi, sa massimu ta' 60 ġurnata.
English: APL. Frequencies are defined as: (very common ≥ 1/10), (common ≥ 1/100 to < 1/10), (uncommon ≥
Maltese: (komuni ħafna ≥1/10), (komuni ≥1/100 sa <1/10), (mhux komuni ≥1/1,000 sa <1/100), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
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 leukocytosis.
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, ikkaraterizzat minn deni, qtugħ ta' nifs, żieda fil-piż, infiltrati pulmonari u effużjonijiet plewrali jew perikardjali, ma' jew mingħajr il-lewkoċiti.
English: Arsenic trioxide must be administered intravenously at a dose of 0.15 mg/kg/day, 5 days per week.
Maltese: Arsenic trioxide għandu jingħata ġol-vina b'doża ta' 0.15 mg/kg/jum, 5 ijiem kull ġimgħa.
English: Prior to initiating therapy with arsenic trioxide, a 12-lead ECG must be performed and serum electrolytes (potassium, calcium, and magnesium) and creatinine must be assessed; preexisting electrolyte abnormalities must be corrected and, if possible, medicinal products that are known to prolong the QT interval must be discontinued.
Maltese: Qabel ma tibda tingħata t-terapija b'arsenic trioxide, irid isir 12-lead ECG u l-elettroliti fis-serum (potassium, calcium, u magnesium) u l-kreatinina jridu jiġu assessjati, abnormalitajiet ta' elettroliti li diġà kienu jeżistu jridu jiġu kkorreġuti u, jekk hu possibbli, prodotti mediċinali li huma magħrufa li jtawlu l-intervall QT iridu jitwaqqfu.
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: Ilkonċentrazzjoni fil-plażma ta' AsIII tonqos mill-konċentrazzjoni massima fil-plażma b'mod bifażiku b'half-life medja tal-eliminazzjoni terminali ta' 10 sigħat sa 14-il siegħa.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull volum unitarju, jiġifieri essenzjalment “ħieles mis-sodium”.
English: Arsenic trioxide has been investigated in 77 newly diagnosed patients with low to intermediate risk APL, in a controlled, randomized, non-inferiority Phase 3 clinical study comparing the efficacy and safety of arsenic trioxide combined with all-trans-retinoic acid (ATRA) with those of ATRA+chemotherapy (eg, idarubicin and mitoxantrone) (Study APL0406).
Maltese: Pazjenti b'APL ta' riskju mhux għoli ddijanjostikata għall-ewwel darba arsenic trioxide kien investigat f'77 pazjent iddijanjostikati għall-ewwel darba b'APL ta' riskju baxx sa intermedju, fi studju kliniku ta' Fażi 3 ikkontrollat, randomised, dwar nuqqas ta' inferjorità li qabbel l-effikaċja u s-sigurtà ta' arsenic trioxide flimkien ma' all-trans-retinoic acid (ATRA) ma' dawk ta' ATRA+kimoterapija (eż., idarubicin u mitoxantrone) (Studju APL0406).
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: It-tneħħija totali ta' AsIII 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: Very common
Maltese: Komuni Komuni
English: Arsenic trioxide Accord must be administered intravenously over 1-2 hours.
Maltese: Arsenic trioxide Accord għandu jingħata fil-vina fuq firxa ta' 1-2 sigħat.
English: In case of reappearance of hepatotoxicity, arsenic trioxide must be permanently discontinued.
Maltese: Jekk jerġa' jkun hemm epatossiċità, arsenic trioxide għandu jitwaqqaf b'mod permanenti.
English: You may experience convulsions, muscle weakness and confusion.
Maltese: Int għandek mnejn ikollok konvulsjonijiet, indebboliment muskolari u konfużjoni.
English: Arsenic trioxide must be administered intravenously over 1-2 hours.
Maltese: Arsenic trioxide għandu jingħata fil-vina fuq firxa ta' 1-2 sigħat.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Parestesija
English: Twenty-seven patients had leukocytosis (WBC ≥ 10 x 103/µl) during induction, 4 of whom had values above 100,000/µl.
Maltese: Sebgħa u għoxrin pazjent kellhom lewkoċitożi (WBC  10 x 103/l) matul l-induzzjoni, 4 minnhom kellhom valuri ogħla minn 100,000/l.
English: - Blood tests (potassium, calcium, magnesium and liver function) should be repeated during your treatment with Arsenic trioxide Accord.
Maltese: - Testijiet tad-demm (potassium, calcium, funzjoni tal-fwied) għandhom jiġi rripetuti matul ilkura tiegħek b'Arsenic trioxide Accord.
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 3 months.
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: The mean estimated terminal elimination half-lives of the metabolites MMAV and DMAV
Maltese: Il-half-lives medji stmati tal-eliminazzjoni terminali tal-metaboliti MMAV u DMAV huma 32 siegħa u 70 siegħa, rispettivament.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull volum unitarju, jiġifieri essenzjalment “ħielsa mis-sodium”.
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 żieda fittossiċità.
English: During therapy with arsenic trioxide, 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'arsenic trioxide, 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: Arsenic trioxide Accord contains arsenic trioxide which is an anticancer medicine.
Maltese: Arsenic trioxide Accord fih arsenic trioxide li huwa mediċina kontra l-kanċer.
English: Peripheral neuropathy, characterised by paresthesia/dysesthesia, is a common and well known effect of environmental arsenic.
Maltese: Newtropatija periferali, ikkaratterizzata minn parestesija/disestesija hi komuni u effett magħruf sew ta' arseniku ambjentali.
English: Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion
Maltese: Arsenic trioxide Accord 1 mg/mL konċentrat għal soluzzjoni għall-infużjoni
English: - The other ingredients are sodium hydroxide, concentrated hydrochloric acid (for pH adjustment) and water for injections.
Maltese: - Is-sustanzi l-oħra huma sodium hydroxide, hydrochloric acid ikkonċentrat (għall-aġġustament tal-pH) u ilma għal injezzjonijiet.
English: During arsenic trioxide treatment, 14 of the 52 patients in the APL studies in the relapsed setting had one or more symptoms of APL differentiation syndrome, characterised by fever, dyspnoea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis (see section 4.4).
Maltese: Matul it-trattament b'arsenic trioxide, 14 minn 52 pazjent fl-istudji ta'APL f'ambjent ta' rkadar kellhom wieħed jew aktar mis-sintomi ta' sindrome ta' divrenzjar ta' APL, ikkaraterizzat b'deni, qtugħ ta' nifs, żieda fil-piż, infiltrati pulmonari u effużjonijiet plewrali jew perikardjali, bil- jew mingħajr lewkoċitożi (ara sezzjoni 4.4).
English: In clinical trials, in the relapsed/refractory setting, 40% of patients treated with arsenic trioxide 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 arsenic trioxide infusion, and then returned to baseline by the end of 8 weeks after arsenic trioxide infusion.
Maltese: Fi studji kliniċi, f'ambjent ta' rkadar/refrattarju, 40% talpazjenti li kienu kkurati b'arsenic trioxide esperjenzaw tal-anqas titwil tal-intervall QT kkorreġut (QTc) ta' aktar minn 500 msec.
English: The plasma clearance of AsIII in patients with severe renal impairment (creatinine clearance less than 30 mL/min) was 40% lower when compared with patients with normal renal function (see section 4.4).
Maltese: It-tneħħija mill-plażma ta' AsIII f'pazjenti b'indeboliment renali sever (tneħħija talkrejatinina inqas minn 30 mL/min) kienet 40% inqas meta mqabbel ma' pazjenti b'funzjoni renali normali (ara sezzjoni 4.4).
English: Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and 48 hours at 2°C to 8°C.
Maltese: Kemm hu kimikament u fiżikament stabbli waqt l-użu ntwera għal 24 siegħa f'25 °C u 48 siegħa f'2°C sa 8°C.
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 arsenic trioxide 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'arsenic trioxide flimkien ma' ATRA meta mqabbla ma' pazjenti ttrattati b'ATRA + kimoterapija.
English: Febrile neutropenia
Maltese: Disturbi vaskulari Vaskulite
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 tal-età minn 9 sa 75).