FrancophonIA/ELRC3.0 huggingface dataset:
English: • omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors for reducing stomach acid);
Maltese: • omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol (inibituri tal-pompa tal-proton għattnaqqis tal-aċidu fl-istonku);
English: Edurant is a medicine that contains the active substance rilpivirine.
Maltese: Edurant huwa mediċina li fiha s-sustanza attiva rilpivirina.
English: This is a summary of the European public assessment report (EPAR) for Edurant.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Edurant.
English: Taking the two studies into account, 84% of patients taking Edurant responded to treatment after one year, compared with 82% of patients taking efavirenz.
Maltese: Meta wieħed iqis iż-żewġ studji, 84% tal-pazjenti li kienu qegħdin jieħdu Edurant rrispondew għall-kura wara sena, meta mqabbla ma' 82% tal-pazjenti li kienu qegħdin jieħdu efavirenz.
English: The most frequent side effects with Edurant (seen in more than 1 patient in 10) are headache, insomnia, dizziness, nausea (feeling sick), and increased levels of total cholesterol, low-densitylipoprotein (LDL) cholesterol, pancreatic amylase (an enzyme produced in the pancreas that breaks down starch into sugars) and transaminases (liver enzymes).
Maltese: L-effetti sekondarji l-aktar komuni b'Edurant (li jidhru f'iktar minn pazjent 1 minn kull 10) huma wġigħ ta' ras, insomnja, sturdament, dardir (tħossok ma tiflaħx), żieda fil-livelli tal-kolesterol totali, kolesterol tal-lipoproteina ta' densità baxxa (LDL)), amilażi tal-frixa (enzima prodotta fil-frixa li tkisser il-lamtu f'zokkor) u transaminażi (enzimi tal-fwied).
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to make more viruses in the cells it has infected.
Maltese: Timblokka l-attività tat-transkrittażi inversa, enzima prodotta mill-HIV-1 li jippermettilha li tagħmel aktar virusijiet fiċ-ċelloli li tkun infettat.
English: Edurant is used in combination with other antiviral medicines to treat adults and adolescents from the age of 12 years who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Edurant jintuża flimkien ma' mediċini antivirali oħra fil-kura ta' adulti u adoloxxenti minn tnax-il sena 'l fuq infettati mill-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu minn immunodefiċjenza akkwiżita (AIDS).
English: Edurant was investigated in two main studies in 1,368 previously untreated adult patients infected with HIV-1.
Maltese: Edurant ġie investigat f'żewġ studji ewlenin f'1,368 pazjent infettati bl-HIV-1 li ma ġewx ikkurati qabel.
English: How has Edurant been studied?
Maltese: Kif ġie studjat Edurant?
English: Why has Edurant been approved?
Maltese: Għaliex ġie approvat Edurant?
English: Edurant was also investigated in another study in 36 previously untreated adolescents (between 12 and 18 years old) infected with HIV-1.
Maltese: Edurant kien investigat ukoll fi studju ieħor f'36 adoloxxenti li ma kinux ikkurati qabel (bejn 12 u 18-il sena) infettati bl-HIV-1.
English: What benefit has Edurant shown during the studies?
Maltese: Liema benefiċċju wera Edurant waqt l-istudji mwettqa?
English: A risk management plan has been developed to ensure that Edurant is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jiżgura li Edurant jintuża bl-aktar mod sigur possibbli.
English: It is only used in patients who have not received anti-HIV treatment before and who have HIV levels in the blood (viral load) of no more than 100,000 HIV-1 RNA copies/ml.
Maltese: Jintuża biss fuq pazjenti li ma jkunux irċevew kura qabel kontra lHIV u li għandhom livelli ta' HIV fid-demm (tagħbija virali) ta' mhux aktar minn 100,000 HIV-1 RNA kopji/ml.
English: In the second study, Edurant was compared with efavirenz, when both medicines were given in combination with a fixed regimen of antiviral medicines consisting of tenofovir disoproxil and emtricitabine or two other nucleoside or nucleotide reverse transcriptase inhibitors.
Maltese: Fit-tieni studju, Edurant tqabbel ma' efavirenz, meta ż-żewġ mediċini ngħataw f'kombinazzjoni ma' reġimen stabbilit ta' mediċini antivirali li jikkonsistu minn tenofovir disoproxil u emtricitabine jew żewġ nukleosidi jew inibituri mhux nukleosidiċi tat-transkrittażi inversa oħrajn.
English: What measures are being taken to ensure the safe and effective use of Edurant?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat użu sigur u effettiv ta' Edurant?
English: In adults, Edurant in combination with other antiretroviral medicines was as effective as the comparator medicine at reducing the level of HIV-1 in the patients' blood.
Maltese: Edurant, f'kombinazzjoni ma' mediċini antiretrovirali oħrajn, kien effettiv daqs il-mediċina tat-tqabbil fit-tnaqqis tal-livell ta' HIV-1 fid-demm tal-pazjenti.
English: What is the risk associated with Edurant?
Maltese: Għal xiex jintuża Edurant?
English: Therefore, the CHMP considered that the benefits of Edurant outweigh its risks in patients with a low HIV-1 viral load, and recommended that it be granted marketing authorisation for this group of patients.
Maltese: Għaldaqstant, is-CHMP ikkunsidra li l-benefiċċji ta' Edurant huma akbar mir-riskji tiegħu f'pazjenti b'tagħbija virali baxxa ta' HIV-1, u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq għal dan il-grupp ta' pazjenti.
English: However, the CHMP noted that there was some risk of HIV-1 developing resistance to rilpivirine and that this risk appeared to be lower in patients with a lower viral load.
Maltese: Madankollu, is-CHMP innota li kien hemm xi riskju li l-HIV-1 jiżviluppa reżistenza għarrilpivirina u li dan ir-riskju deher li kien aktar baxx f'pazjenti b'tagħbija virali aktar baxxa.
English: The CHMP concluded that Edurant, in combination with other antiretroviral medicines, was as effective as the main NNRTI currently used in the first-line treatment of adult patients infected with HIV-1.In addition, Edurant has also been shown to be effective in children aged 12 to 18 years of age.
Maltese: Is-CHMP ikkonkluda li Edurant, flimkien ma' mediċini antiretrovirali oħra, kien effettiv daqs l-NNRTI prinċipali li qed jintuża bħalissa bħala l-ewwel linja ta' kura f'pazjenti infettati bl-HIV-1.
English: Edurant does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Edurant ma jikkurax l-infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara li ssir lis-sistema immuni u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.
English: How does Edurant work?
Maltese: X'inhu Edurant?
English: Edurant was given in combination with a fixed regimen of antiviral medicines and was not compared with another treatment.
Maltese: Edurant ingħata flimkien ma' skeda stabbilita ta' mediċini antivirali u ma tqabbilx ma' kura oħra.
English: (see section 4.2)
Maltese: (ara sezzjoni 4.2)
English: Grades ≥ 3
Maltese: Gradi ≥3
English: Date of first authorisation: 05 March 2002 Date of latest renewal: 05 March 2007
Maltese: Data tal-ewwel awtorizzazzjoni: 05 Marzu 2002 Data tal-aħħar tiġdid: 05 Marzu 2007
English: Conventional Cytogenetics [t(15;17)] Absent
Maltese: Konvenzjonali [t(15;17)]
English: Laboratory tests
Maltese: Testijiet fil-laboratorju
English: ATRA + Chemotherapy (n = 79)
Maltese: ATRA + Kimoterapija (n=79)
English: Electrocardiogram (ECG) abnormalities
Maltese: Abnormalitajiet elektrokardjogrammi (ECG)
English: 3 months.
Maltese: 3 snin.
English: Ventricular extrasystoles
Maltese: Extrasystoles ventrikulari
English: TRISENOX is normally given by a doctor or a nurse.
Maltese: TRISENOX normalment jingħata minn tabib jew infermier.
English: Pulmonary alveolar haemorrhage
Maltese: Emorraġija alveolari pulmonari
English: Hepatotoxicity (grade 3-4)
Maltese: Epatossiċità (grad 3-4)
English: Aspartate amino transferase increased
Maltese: Żieda f'aspartate amino transferase
English: See section 2 “TRISENOX contains sodium”.
Maltese: Ara sezzjoni 2 “TRISENOX fih sodium”.
English: Almac Pharma Services (Ireland) Limited; Finnabair Industrial Estate, Dundalk, Co. Louth, A91 P9KD, Ireland
Maltese: Almac Pharma Services (Ireland) Limited; Finnabair Industrial Estate, Dundalk, Co. Louth, A91 P9KD, L-Irlanda
English: P-value
Maltese: Valur p
English: Almac Pharma Services Limited, Almac House, 20 Seagoe Industrial Estate, Craigavon, BT63 5QD, United Kingdom
Maltese: Almac Pharma Services Limited, Almac House, 20 Seagoe Industrial Estate, Craigavon, BT63 5QD, Ir-Renju Unit
English: Table 1 Recommendation for initiation of hydroxyurea WBC
Maltese: Tabella 1 Rakkomandazzjoni biex tinbeda hydroxyurea WBC
English: Arsenic compounds induce chromosomal aberrations and morphological transformations of mammalian cells in vitro and in vivo.
Maltese: Kompownds arseniċi jikkaġunaw aberrazzjonijiet kromosomali u trasformazzjonijiet morfoloġikali ta' ċelluli mammaljani in vitro u in vivo.
English: Not evaluable RT-PCR for PML/ RAR
Maltese: RT-PCR għal PML/
English: TRISENOX contains sodium
Maltese: TRISENOX fih sodium
English: Single centre pilot trial N with CR = 11
Maltese: Esperiment pilota ta' ċentru uniku N ma' KR=11
English: The active ingredient of TRISENOX, arsenic trioxide, is a human carcinogen.
Maltese: Is-sustanza attiva ta' TRISENOX, arsenic trioxide, hija karċinoġenu uman.
English: 95 % CI for the difference, percentage points p < 0.001 for non-inferiority p = 0.02 for superiority of ATRA + TRISENOX
Maltese: għad differenza, 2-22 punti perċentwali p<0.001 għal nuqqas ta' inferjorità p=0.02 għal superjorità ta' ATRA+TRISENOX
English: No data are available on patient with variant translocations like t(11;17) (PLZF/RARα).
Maltese: M'hemm l-ebda data disponibbli dwar pazjenti bi traslokazzjonijiet varjanti bħal t(11;17) (PLZF/RARα).
English: Single centre trial N=12
Maltese: Studju ċentriku uniku N=12
English: 12 mg/6 ml
Maltese: 12-il mg/6 mL
English: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Maltese: Teva Pharmaceuticals Europe B.V., Swensweg 5, 2031 GA Haarlem, L-Olanda
English: Confidence interval (CI)
Maltese: Intervall ta' kunfidenza (CI)
English: Arsenic trioxide can cause QT interval prolongation (see section 4.4).
Maltese: Arsenic trioxide jista' jikkaġuna titwil ta' l-intervall QT (ara sezzjoni 4.4).
English: Haematologic complete remission (HCR)
Maltese: Remissjoni ematoloġika kompleta (HCRHematologic complete remission)
English: Psychiatric disorders Confusional state
Maltese: Disturbi psikjatriċi Stat ta' konfużjoni
English: TRISENOX contains less than 1 mmol sodium (23 mg) per dose.
Maltese: TRISENOX fih anqas minn 1 mmol sodium (23 mg) f'kull doża.
English: Pleural effusion
Maltese: Effużjoni plewrali
English: 2031 GA Haarlem, The Netherlands
Maltese: 2031 GA Haarlem, L-Olanda
English: After dilution in intravenous solutions, TRISENOX is chemically and physically stable for 24 hours at 15-30 °C and 72 hours at refrigerated (2-8 °C) temperatures.
Maltese: Wara d-dilwazzjoni fis-soluzzjoni fil-vina, TRISENOX hu kemikalment u fiżikament stabbli għal 24 siegħa f'15-30°C u 72 siegħa f'temperaturi fil-friġġ (2-8°C).
English: Each pack contains 10 ampoules.
Maltese: Kull pakkett fih 10 ampulli.
English: TRISENOX dose, mg/kg/day (median, range) Complete remission Time to bone marrow remission (median)
Maltese: TRISENOX, mg/kg/kuljum (medjana, firxa) Remissjoni kompleta
English: 2-Year event-free survival (EFS)
Maltese: Sopravivenza mingħajr avvenimenti (EFSevent-free survival) ta' sentejn
English: One was a single investigator clinical study (n=12) and the other was a multicentre, 9-institution study (n=40).
Maltese: Wieħed minnhom kien kliniku ta' investigatur (n=12) u l-ieħor kien multiċentriku, studju ta' 9-instituzzjoni (n=40).
English: • medicines for depression (e.g. amitriptyline)
Maltese: • mediċini għall-kura ta' dipressjoni (eż. amitriptyline)
English: For ECG, electrolytes abnormalities and hepatotoxicity see section 4.4.
Maltese: Għal abnormalitajiet tal-ECG, tal-elettroliti u epatotossiċità, ara sezzjoni 4.4.
English: • some types of antiarrhythmics (medicines used to correct irregular heart beats, e.g. quinidine, amiodarone, sotalol, dofetilide)
Maltese: • xi tipi ta' mediċini kontra l-arritmija (mediċini wżati biex jiġi kkoreġut taħbit irregolari tal-qalb, eż. quinidine, amiodarone, sotalol, dofetilide)
English: Arsenic trioxide also causes damage or degradation of the fusion protein promyelocytic leukaemia/retinoic acid receptor-alpha (PML/RAR alpha).
Maltese: L-Arsenic trioxide jikkawża wkoll dannu jew degradazzjoni fil-protein tal-fużjoni Pro-Myelocytic Leukaemia/Retinoic Acid Receptoralpha (PML/RAR alpha).
English: Some cases recovered with vitamin B1 supplementation.
Maltese: vitamina B1.
English: AsIII is the pharmacologically active species of arsenic trioxide.
Maltese: AsIII huwa l-ispeċi attiva farmakoloġikament ta' arsenic trioxide.
English: Consolidation schedule
Maltese: Skeda ta' konsolidazzjoni
English: Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block.
Maltese: L-Arsenic trioxide jista' jikkawża titwil ta' l-intervall QT u l-imblokkar komplet atrijoventrikulari.
English: Investigations Alanine amino transferase increased
Maltese: Żieda f'alanine aminotransferase
English: • Relapsed/refractory acute promyelocytic leukaemia (APL) (previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
Maltese: • Lewkimja promijeloċitika li tirkadi/refrattarja (APL) (it-trattament li ngħata qabel kellu jinkludi retinojd u kimoterapija) karatterizata mill-preżenza tat-translokazzjoni t(15;17) u/jew il preżenza tal-ġene ta' lewkimja promijeloċitika/riċettur tal-aċidu retinojku-alfa (PML/RAR-alfa).
English: If complete remission has not occurred by day 60, dosing must be discontinued.
Maltese: Jekk ma jkunx hemm remissjoni kompleta sa jum 60, id-dożaġġ għandu jitwaqqaf.
English: QT interval prolongation
Maltese: Titwil tal-intervall QT
English: No formal assessments of pharmacokinetic interactions between TRISENOX and other therapeutic medicinal products have been conducted.
Maltese: Ma saru l-ebda assessjamenti formali ta' interazzjonijiet ta' farmakokinetiċi bejn TRISENOX u prodotti mediċinali terapewtiċi oħra.
English: Each pack contains 10 vials.
Maltese: Kull pakkett fih 10 kunjetti.
English: AsV is present in plasma only at relatively low levels.
Maltese: AsV huwa preżenti fil-plażma f'livelli relattivament baxxi biss.
English: In newly diagnosed patients, with low to intermediate risk APL, QTc prolongation was observed in 15.6 %.
Maltese: F'pazjenti ddijanjostikati għall-ewwel darba, b'APL ta' riskju baxx sa intermedju, kien osservat titwil ta' QTc f'15.6%.
English: Cytogenetic confirmation of conversion to a normal genotype and reverse transcriptase - polymerase chain reaction (RT-PCR) detection of PML/RAR conversion to normal are shown in table 5 below.
Maltese: Konfirmazzjoni ċitoġenetika tal-bidla għal ġenotip normali u l-bidla ta' Rreverse transcriptase polymerase chain reaction (RT-PCR) detection of PML/RARα għan-normal huma murija fit-tabella 5
English: Ventricular tachycardia
Maltese: Takikardija ventrikulari
English: Distribution The volume of distribution (Vd) for AsIII is large (> 400 l) indicating significant distribution into the tissues with negligible protein binding.
Maltese: Distribuzzjoni Il-volum ta' distribuzzjoni (Vd) għal AsIII huwa kbir (>400 L) u dan jindika distribuzzjoni sinifikanti ġewwa t-tessuti bi twaħħil negliġibbli mal-proteini.
English: The inorganic, lyophilized form of arsenic trioxide, when placed into solution, immediately forms the hydrolysis product arsenious acid (AsIII).
Maltese: Il-forma inorganika u lajofiliżżata ta' arsenic trioxide, meta mqegħda ġewwa soluzzjoni, tifforma immedjatament il-prodott ta' idrolisi arsenious acid (AsIII).
English: In newly diagnosed patients with low to intermediate risk APL leucocytosis developed during induction therapy in 35 of 74 (47 %) patients (see section 4.8).
Maltese: F'pazjenti ddijanjostikati għall-ewwel darba b'APL ta' riskju baxx sa intermedju, żviluppat lewkoċitożi matul it-terapija ta' induzzjoni f'35 minn 74 (47%) pazjent (ara sezzjoni 4.8).
English: Hypernatraemia
Maltese: Ipernatremija
English: Haematological and gastrointestinal toxicity
Maltese: Tossiċità ematoloġika u gastro-intestinali
English: There is no experience on the effect of TRISENOX on the variant APL containing the t(11;17) and t(5;17) chromosomal translocations.
Maltese: M'hemmx esperjenza fuq l-effett ta' TRISENOX fuq il-varjant APL li fih it-t(11;17) u t(5;17) translokazzjoni kromożomali.
English: • medicines to treat psychosis (loss of contact with reality, e.g. thioridazine)
Maltese: • mediċini għall-kura ta' psikożi (telf ta' kuntatt mar-realtà, eż. thioridazine)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/204/002
Maltese: UE/1/02/204/002
English: Each ampoule of 10 ml contains 10 mg of arsenic trioxide.
Maltese: Kull ampulla ta' 10 mL fiha 10 mg ta' arsenic trioxide.
English: Biotransformation The metabolism of arsenic trioxide involves oxidation of arsenious acid (AsIII), the active species of arsenic trioxide, to arsenic acid (AsV), as well as oxidative methylation to monomethylarsonic acid (MMAV) and dimethylarsinic acid (DMAV) by methyltransferases, primarily in the liver.
Maltese: arsenic trioxide, għal arsenic acid (AsV), kif ukoll il-metilazzjoni ossidattiva għal monomethylarsonic acid (MMAV) u dimethylarsinic acid (DMAV) permezz ta' methyltransferases, primarjament fil-fwied.
English: Limited reproductive toxicity studies of arsenic trioxide in animals indicate embryotoxicity and teratogenicity (neural tube defects, anophthalmia and microphthalmia) at administration of 1-10 times the recommended clinical dose (mg/m2).
Maltese: Studji limitati dwar it-tossiċità fuq is-sistema riproduttiva ta' arsenic trioxide f'bhejjem jindikaw embrijutossiċità u teratoġeniċità (difetti ta' tubu newrali, anoftalmija u mikroftalmija) fid-dożi mogħtija ta' minn 1 sa 10 darbiet id-doża klinika rakkomandata (mg/m2).
English: • Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/µl) in combination with all-trans-retinoic acid (ATRA)
Maltese: • Lewkimja promijeloċitika akuta (APL - acute promyelocytic leukaemia) ta' riskju baxx sa intermedju ddijanjostikata għall-ewwel darba (għadd ta' ċelluli bojod tad-demm, ≤10 x 103/µL)
English: 54 days
Maltese: 54 ġurnata
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 mill-istudju.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/204/001
Maltese: UE/1/02/204/001
English: Patients tended to tolerate consolidation and maintenance treatment with less toxicity than in induction.
Maltese: Il-pazjenti kellhom it-tendenza li jittoleraw trattament ta' konsolidazzjoni u ta' manteniment b'inqas tossiċità mill-induzzjoni.
English: Relapsed/refractory acute promyelocytic leukaemia (APL) Induction treatment schedule
Maltese: Lewkimja promijeloċitika akuta (APL) li tirkadi/refrattarja
English: In the total single dose range of 7 to 32 mg (administered as 0.15 mg/kg), systemic exposure (AUC) appears to be linear.
Maltese: Fil-firxa totali ta' doża waħda ta' 7 sa 32 mg (mogħti bħala 0.15 mg/kg), l-esponiment sistemiku (AUC) jidher li huwa lineari.
English: The methylated metabolites of AsIII (MMAV, DMAV) are primarily excreted in the urine.
Maltese: Ilmetaboliti metilati ta' AsIII (MMAV, DMAV) huma mneħħija primarjament fl-awrina.
English: The mean estimated terminal elimination half-lives of the metabolites MMAV and DMAV are 32 hours and
Maltese: Il-half-lives medji stmati ta' l-eliminazzjoni terminali tal-metaboliti MMAV u DMAV huma 32 siegħa u 70 siegħa, rispettivament.
English: Marketing Authorisation Holder Teva B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Maltese: Teva B.V., Swensweg 5, 2031 GA Haarlem, L-Olanda
English: Consolidation therapy began 6 weeks (range, 3-8) after induction in the single institution study and 4 weeks (range, 3-6) in the multicentre study.
Maltese: It-terapija ta' konsolidazzjoni bdiet 6 ġimgħat (firxa, 3-8) wara l-induzzjoni fl-uniku studju instituzzjonali u 4 ġimgħat (firxa, 3-6) fl-istudju multiċentriku.
English: TRISENOX 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 TRISENOX combined with all-trans-retinoic acid (ATRA) with those of ATRA + chemotherapy (eg, idarubicin and mitoxantrone) (Study APL0406).
Maltese: TRISENOX 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 leffikaċja u s-sigurtà ta' TRISENOX flimkien ma' all-trans-retinoic acid (ATRA) ma' dawk ta' ATRA+kimoterapija (eż., idarubicin u mitoxantrone) (Studju APL0406).
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: - Blood tests (potassium, calcium, magnesium and liver function) should be repeated during your treatment with TRISENOX.
Maltese: - Testijiet tad-demm (potassium, calcium, magnesium u funzjoni tal-fwied) għandhom jiġi rripetuti matul il-kura tiegħek bi TRISENOX.
English: What TRISENOX contains - The active substance is arsenic trioxide.
Maltese: - Is-sustanza attiva hi arsenic trioxide.
English: TRISENOX 2 mg/ml concentrate for solution for infusion 6 ml concentrate in a clear, Type I borosilicate glass vial with a chlorobutyl rubber stopper (FluroTec coated plug) and an aluminium crimp cap with a plastic flip-top button.
Maltese: 6 mL ta' konċentrat f'kunjett tal-ħġieġ ċar borosilikat Tip I b'tapp tal-gomma chlorobutyl (tapp miksi bi FluroTec) u għatu ippjegat tal-aluminju b'buttuna flip-top tal-plastik.
English: TRISENOX 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: TRISENOX 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: • some types of medicines to treat bacterial infections (e.g. erythromycin and sparfloxacin)
Maltese: • xi tipi ta' mediċini għall-kura ta' infezzjonijiet batterjali (eż. erythromycin u sparfloxacin)
English: Excipients: sodium hydroxide, hydrochloric acid, water for injections
Maltese: Eċċipjenti: sodium hydroxide, hydrochloric acid, ilma għall-injezzjonijiet
English: 35 days
Maltese: 35 ġurnata
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 ta' l-età minn 5 sa 73).
English: Patients at risk of B1 deficiency should be closely monitored for signs and symptoms of encephalopathy after arsenic trioxide initiation.
Maltese: Pazjenti b'riskju ta' defiċjenza ta' B1 għandhom jiġu mmonitorjati mill-qrib għal sinjali u sintomi ta' enċefalopatija wara li jinbeda l-arsenic trioxide.