FrancophonIA/ELRC3.0 huggingface dataset:
English: * NYHA: New York Heart Association ** LVEF: Left Ventricular Ejection Fraction
Maltese: * NYHA: Assoċjazzjoni tal-Qalb ta' New York (New York Heart Association) ** LVEF: Frazzjoni tal-Ħruġ Ventrikolari tax-Xellug (Left Ventricular Ejection Fraction)
English: Event (death) Median OS (95% CI)
Maltese: Avveniment (mewt) OS medju (95% CI)
English: The active substance is pixantrone.
Maltese: Is-sustanza attiva hija pixantrone.
English: P-value
Maltese: valur P
English: Acetylated metabolites were pharmacologically inactive and metabolically stable.
Maltese: Il-metaboliti aċetilati kienu farmakoloġikament inattivi u metabolikament stabbli.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/764/001
Maltese: EU/1/12/764/001
English: Dark blue lyophilised powder.
Maltese: Trab lijofilizzat blu skur.
English: The recommended dose is 50 mg/m2.
Maltese: Id-doża rakkomandata hija 50 mg/m2.
English: Comparator (n=70)
Maltese: Komparatur (n=70)
English: Prevention of photosensitivity reactions
Maltese: Prevenzjoni ta' reazzjonijiet ta' fotosensittività
English: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton, Lancashire BL5 3XX United Kingdom
Maltese: Catalent UK Packaging Limited Lancaster Way,Wingates Industrial Estate Westhoughton, Bolton, Lancashire BL5 3XX Ir-Renju Unit
English: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton Lancashire BL5 3XX United Kingdom
Maltese: Catalent UK Packaging Limited Lancaster Way, Wingates Industrial Estate Westhoughton, Bolton Lancashire BL5 3XX Ir-Renju Unit
English: Pixuvri Dose (mg/m2) Number of patients
Maltese: Doża ta' Pixuvri (mg/m2) Numru ta' Pazjenti
English: Infections, including pneumonia, cellulitis, bronchitis, and sepsis have been reported during clinical trials (see section 4.8).
Maltese: Ġew irrapportati infezzjonijiet, inklużi pulmonite, ċellulite, bronkite, u sepsis waqt il-provi kliniċi (ara sezzjoni 4.8).
English: No other significant clinically relevant interactions with CYPP450s were observed.
Maltese: Ma ġiet osservata l-ebda interazzjoni klinikament sinifikanti oħra b'CYPP450s.
English: Uncommon Spontaneous penile erection
Maltese: Erezzjoni spontanja tal-pene
English: log rank p-value = 0.251 HR = 0.79 (95% CI 0.53, 1.18)
Maltese: HR = 0.79 (95% CI 0.53, 1.18)
English: Uncommon Esophagitis, oral paresthesia, rectal haemorrhage
Maltese: Esofaġite, parestesija orali, emorraġija rettali
English: Pixuvri has been shown to cause phototoxic effects on 3T3 cells in vitro.
Maltese: Pixuvri ntwera li jikkawża effetti fototossiċi fuq ċelloli 3T3 in vitro.
English: Date of latest renewal: 06 June 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 10 ta' Mejju 2012 Data tal-aħħar tiġdid: 06 ta' Ġunju 2019
English: Secondary malignancy
Maltese: Tumuri malinni sekondarji
English: In the EU recommended dose refers to the base of the active substance (pixantrone).
Maltese: Fl-UE d-doża rakkomandata tirreferi għall-bażi tas-sustanza attiva (pixantrone).
English: Figure 2 PIX 301 Overall survival-end of study
Maltese: 2 PIX 301 Sopravvivenza globali - tmiem l-istudju
English: Figure 1 PIX301 Progression-free survival - end of study
Maltese: PIX301 Sopravvivenza mingħajr progressjoni - tmiem l-istudju
English: Pharmacokinetics of pixantrone proved to be linear in a broad range of doses, from 3 mg/m2 to 105 mg/m2.
Maltese: Il-farmakokinetika ta' pixantrone uriet li hija lineari f'medda wiesgħa ta' dożi, minn 3 mg/m2 sa 105 mg/m2.
English: Hepatic uptake of pixantrone is possibly mediated by OCT1 active transporters and biliary excretion by P-gp and BCRP.
Maltese: It-teħid epatiku ta' pixantrone huwa possibbilment medjat permezz ta' trasportaturi attivi b'OCT1 u t-tneħħija biljari permezz ta' P-gp u BCRP.
English: (listed in section 6).
Maltese: (imniżżlafis-sezzjoni 6).
English: * ADRs discussed below
Maltese: * ADRs diskussi hawn taħt
English: Patients with serum creatinine > 2 x Upper Limit of the Normal range (ULN) were excluded from the randomised studies.
Maltese: Il-pazjenti bil-kreatinina fis-serum > 2 x l-Ogħla Limitu tal-Medda Normali (ULN) kienu esklużi mill-istudji aleatorji.
English: Sodium chloride
Maltese: Sodium chloride Lactose monohydrate
English: From an analysis of population PK data, for a target recorded dose of 50 mg/m2 of pixantrone the median 28-day cycle exposure was 6320 ng.hr/ml (90% CI, 5990-6800 ng.hr/ml), for 3 doses / 4 week cycle.
Maltese: Minn analiżi ta' dejta tal-PK tal-popolazzjoni, għal doża rreġistrata mmirata ta' 50 mg/m2 ta'pixantrone, l-espożizzjoni medja taċ-ċiklu ta' 28 jum kienet 6320 ng.hr/ml (90% CI, 5990-6800 ng.hr/ml), għal 3 dożi /ċikli ta' 4 ġimgħat.
English: Common Neutropenic infection, respiratory tract infection, infection, sepsis
Maltese: Infezzjoni newtropenika, infezzjoni fl-apparat respiratorju, infezzjoni, sepsis
English: Genotoxicity studies confirmed the potential for clastogenic effects in mammalian cells in vitro and in vivo.
Maltese: Il-fotosensittività hija riskju potenzjali bbażat fuq dejta mhux klinika in vitro u in vivo.
English: Devices and surfaces accidentally contaminated with Pixuvri must be treated with a solution of sodium hypochlorite (100 µl of water and 20 µl of sodium hypochlorite [7 ± 2% of available chlorine] for 0.58 mg of Pixuvri).
Maltese: Apparat u uċuħ ikkontaminati bi żball b'Pixuvri għandhom jiġu mnaddfa b'soluzzjoni ta' sodium hypochlorite (100 µl ta' ilma u 20 µl ta' sodium hypochlorite [7 ± 2% ta' klorin disponibbli] għal 0.58 mg ta' Pixuvri).
English: ADRs are listed in Table 3 below by MedDRA system organ class and by frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data).
Maltese: < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: In a colony-forming units study in mice, the myelotoxicity of Pixuvri and mitoxantrone administered at their LD10 (pixantrone dimaleate 38 mg/kg and mitoxantrone 6.1 mg/kg) was similar.
Maltese: Fi studju ta' unitajiet li jiffurmaw kolonja fil-ġrieden, il-majelotossiċità ta' Pixuvri u mitoxantrone mogħtija f'LD10 tagħhom (pixantrone dimaleate 38 mg/kg u mitoxantrone 6.1 mg/kg) kienet simili.
English: For the study overall, patient median age was 59, 61% were male, 64% were Caucasian, 76% had Ann Arbor stage III/IV disease at baseline, 74% had a baseline
Maltese: Għall-istudju inġenerali, l-età medja tal-pazjenti kienet 59, 61% kienu rġiel, 64% kienu Kawkasi, 76% kellhom mard bażiku fl-istadju III/IV ta' Ann Arbor, 74% kellhom punteġġ bażiku ≥ 2 tal-Indiċi Pronjostiku Internazzjonali (IPI), u 60% kienu rċevew ≥ 3 kemoterapiji preċedenti.
English: Single doses of pixantrone up to 158 mg/m2 have been given in dose-escalation clinical trials without evidence of dose-related toxicity.
Maltese: Dożi singoli ta' pixantrone sa 158 mg/m2 ingħataw fi provi kliniċi ta' żidiet fid-doża mingħajr evidenza ta' tossiċità relatata mad-doża.
English: Patients treated with Pixuvri demonstrated 40% improvement in progression-free-survival compared to patients treated with comparator agents with 2.7 months longer median PFS ( hazard ratio (HR)=0.60, logrank p=0.005) (see Figure 1 below).
Maltese: Il-pazjenti kkurati b'Pixuvri urew titjib ta' 40% fis-sopravvivenza mingħajr progressjoni meta mqabbla malpazjenti kkurati b'aġenti komparaturi b'PFS medju ta' 2.7 xhur aktar (proporzjon ta' periklu (HR)=0.60, logrank p=0.005) (ara l-Figura 1 hawn taħt).
English: Bronchitis, candidiasis, cellulitis, herpes zoster, meningitis, nail infection, oral fungal infection, oral herpes, pneumonia, salmonella gastroenteritis, septic shock
Maltese: meninġite, infezzjoni fid-dwiefer, infezzjoni fungali orali, herpes orali, pulmonite, gastroenterite salmonella, xokk settiku
English: Similar findings were reported in rats, and in dogs at 116 mg/m2.
Maltese: Riżultati simili kienu rrapportati fil-firien, u fil-klieb b'116 mg/m2.
English: * LLN: Lower Limit of the Normal range ** ANC: Absolute Neutrophil Count
Maltese: Għadd Assolut tan-Newtrofili (Absolute Neutrophil Count)
English: The incidence of severe infections was low and opportunistic infections associated with immunocompromise were not seen.
Maltese: L-inċidenza ta' infezzjonijiet severi kienet baxxa u ma dehrux infezzjonijiet opportunistiċi assoċjati mal-kompromess tal-immunità.
English: Recombinant hematopoietic growth factors may be used according to institutional or European Society for Medical Oncology (ESMO) guidelines.
Maltese: Society for Medical Oncology - ESMO).
English: In the study PIX 301, decreased ejection fraction occurred in 13 patients (19.1%) in the Pixuvri group.
Maltese: Fl-istudju PIX 301, tnaqqis fil-frazzjoni tal-ħruġ seħħ fi 13-il pazjent (19.1%) fil-grupp ta' Pixuvri.
English: Pixantrone has a moderate to high total plasma clearance of 72.7 l/hr and a low renal excretion accounting for less than 10% of the administered dose in 0-24 hours.
Maltese: Pixantrone għandu tneħħija totali moderata sa għolja fil-plażma ta' 72.7 l/siegħa u tneħħija renali baxxa li tammonta għal inqas minn 10% tad-doża mogħtija f'0-24 siegħa.
English: Table 4 Summary of response per independent assessment panel (ITT population) End-of-Treatment
Maltese: Tabella 4 Sommarju tar-rispons skont il-bord ta' valutazzjoni indipendenti (popolazzjoni
English: Based on in vitro studies, pixantrone was found to be a substrate for the membrane transport proteins P-gp/BRCP and OCT1 and agents which inhibit these transporters have the potential to decrease hepatic uptake and excretion efficiency of pixantrone.
Maltese: Skont studji in vitro, pixantrone nstab li huwa sottostrat għall-proteini li jġorru l-membrani P-gp/BRCP u OCT1 u aġenti li jinibixxu lil dawn it-trasportaturi jistgħu jnaqqsu t-teħid epatiku u l-effiċjenza tat-tneħħija ta' pixantrone.
English: gastroenteritis - viral infections such as shingles or reactivation of other virus such as herpes in the mouth - nervousness, sleeplessness - loss of energy - dizziness, vertigo - dryness of the eye - numbness of the mouth - infection of the cornea - allergy to the medicine - decrease in blood calcium and sodium level; increase in blood uric acid level - inflammation or fluid accumulation around the lungs - runny nose - bleeding such as gut bleed, purple spots on body due to broken blood vessels - vein irritation - night sweats - irregular heartbeat - spontaneous erection - skin rash and/or ulceration - pain, swelling, weakness, stiffness in joints or muscles - decreased urinary output - loss of weight - increased bilirubin in blood or urine - inflammation of the gullet - pain in neck, back, extremities - nail infection - neoplasm (tumour) progression - new cancers of the bone marrow or blood, such as acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) - liver damage - bone marrow failure - increased eosinophils in blood.
Maltese: gastroenterite infezzjonijiet virali bħal ħruq ta' Sant'Antnin jew ir-riattivazzjoni ta' virusijiet oħrajn bħall-herpes fil-ħalq nervożiżmu, nuqqas ta' rqad telf ta' enerġija sturdament, vertiġini nixfa fl-għajnejn tnemnim fil-ħalq infezzjoni tal-kornea allerġija għall-mediċina nuqqas fil-livell tal-kalċju u tas-sodju fid-demm; żieda fil-livell tal-aċidu uriku fid-demm infjammazzjoni jew akkumulazzjoni ta' fluwidu madwar il-pulmuni imnieħer iqattar fsada bħal fsada fl-imsaren, tikek vjola fuq il-ġisem minħabba vini miksura irritazzjoni fil-vini għaraq bil-lejl taħbit tal-qalb irregolari erezzjoni spontanja raxx/ jew ulċera fil-ġilda uġigħ, nefħa, dgħufija, ebusija fil-ġogi jew fil-muskoli tnaqqis fil-produzzjoni tal-awrina tnaqqis fil-piż żieda tal-biliribuna fid-demm jew fl-awrina infjammazzjoni fil-griżmejn uġigħ fl-għonq, fid-dahar, fl-estremitajiet infezzjoni fid-dwiefer progressjoni tan-neoplażma (tumur) kanċer ġdid tal-mudullun jew demm, bħal lewkimja majelojde akuta (AML) jew sindromu majelodisplastiku (MDS)
English: Delay treatment until recovery to platelet count ≥ 50 x 109/l and ANC** ≥ 1.0 x 109/l.
Maltese: ≥ 50 x 109/l u ANC** ≥ 1.0 x 109/l.
English: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood creatinine increased
Maltese: Żieda tal-alanine aminotransferase, żieda tal-aspartate aminotransferase, żieda tal-alkaline phosphatase fid demm, żieda tal-kreatinina fid-demm
English: Reconstituted pixantrone solution is stable for up to 24 hours at room temperature (15°C to 25°C) in standard infusion bags.
Maltese: Is-soluzzjoni rikostitwita ta' pixantrone hija stabbli għal 24 siegħa f'temperatura ambjentali (15°C sa 25°C) f'boroż tal-infużjoni standard.
English: One vial contains pixantrone dimaleate equivalent to 29 mg pixantrone
Maltese: Kull kunjett fih pixantrone dimaleate ekwivalenti għal 29 mg pixantrone.
English: B. PACKAGE LEAFLET
Maltese: Tabella 2
English: In vitro studies with the most common human cytochrome P450 isoforms (including CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4) have shown a possible mixed-type inhibition of CYP1A2 and CYP2C8 that may be of clinical relevance.
Maltese: 2C9, 2C19, 2D6, u 3A4) urew inibizzjoni possibbli tat-tip imħallat ta' CYP1A2 u CYP2C8 li tista' tkun ta'
English: 5.2 Pharmacokinetic properties Absorption
Maltese: .2 Tagħrif farmakokinetiku
English: BATCH NUMBER
Maltese: Figura 1
English: This yields a dark blue solution with a pixantrone concentration of 5.8 mg/ml.
Maltese: Dan jagħti soluzzjoni blu skura b'konċentrazzjoni ta' pixantrone ta' 5.8 mg/ml.
English: - Warfarin to prevent blood clot formation - Theophylline to treat lung conditions like emphysema or asthma - Amitriptyline to treat depression - Olanzapine, Clozapine to treat schizophrenia or maniac depression - Haloperidol to treat anxiety and sleeplessness - Ondansetron to prevent nausea and vomiting during chemotherapy - Propranolol to treat high blood pressure
Maltese: - Amitriptyline għall-kura tad-depressjoni - Olanzapine, Clozapine għall-kura tal-iskizofrenija jew depressjoni manijaka - Haloperidol għall-kura tal-ansjetà u tan-nuqqas ta' rqad - Ondansetron għall-prevenzjoni tan-nawsja u tar-rimettar waqt il-kemoterapija
English: Neoplasm progression
Maltese: Progressjoni tan-neoplażma
English: Pharmacokinetic/pharmacodynamic relationship(s) A relationship between plasma exposure to pixantrone and neutrophil count has been observed.
Maltese: Relazzjoni(-jiet) farmakokinetika(ċi)/farmakodinamika(ċi) Ġiet osservata relazzjoni bejn l-espożizzjoni tal-plażma għal pixantrone u l-għadd tan-newtrofili.
English: Pixantrone dimaleate up to 27 mg/kg given twice a week for 4 weeks did not induce any cardiotoxic effects, while mitoxantrone, as expected, was cardiotoxic at all tested doses (0.6, 1.6, and 1.5 mg/kg).
Maltese: 27 mg/kg mogħti darbtejn f'ġimgħa għal 4 ġimgħat ma kkaġunax effetti kardjotossiċi, filwaqt li mitoxantrone, kif mistenni, kien kardjotossiku fid-dożi kollha ttestjati (0.6, 1.6, u 1.5 mg/kg).
English: After a single intravenous administration of Pixuvri at 29 mg/kg and 38 mg/kg, immediate deaths were seen in mice (114 mg/m2, LD10).
Maltese: Wara għotja waħda ta' Pixuvri ġol-vina ta' 29 mg/kg u 38 mg/kg, kien hemm imwiet immedjati fil-ġrieden (114 mg/m2, LD10).
English: Tabulated list of adverse reactions Adverse drug reactions (ADR) reported with Pixuvri are from final data from all completed single agent studies (n=197).
Maltese: Ir-reazzjonijiet avversi għall-mediċina (ADR) irrapportati b'Pixuvri huma minn dejta finali mill-istudji kollha kompluti b'aġent waħdieni (n=197).
English: Pixantrone was a poor inhibitor of OATP1B1 and OATP1B3 uptake transporters in vitro.
Maltese: Pixantrone kien inibitur dgħajjef tat-trasportaturi tat-teħid OATP1B1 u OATP1B3 in vitro.
English: Delay treatment and monitor until recovery.Consider discontinuation for persistent decline in LVEF** of ≥ 15% of baseline value.
Maltese: Ikkunsidra li twaqqaf il-kura għal tnaqqis persistenti f'LVEF** ta' ≥ 15% tal-valur tal-linja bażi.
English: The development of haematological malignancies such as secondary acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) is a recognised risk associated with anthracycline treatment and other topoisomerase II inhibitors.
Maltese: L-iżvilupp ta' tumuri malinni ematoloġiċi bħal lewkimja akuta sekondarja majelojde (AML) jew sindromu majelodisplastiku (MDS) huwa riskju rikonoxxut assoċjat mal-kura b'anthracycline u inibituri oħra topoisomerase II.
English: Patients with cardiac disease or risk factors such as a baseline LVEF value of < 45% by multigated radionuclide (MUGA) scan, clinically significant cardiovascular abnormalities (equal to New York Heart Association [NYHA] grade 3 or 4), myocardial infarction within the last 6 months, severe arrhythmia, uncontrolled hypertension, uncontrolled angina, or prior cumulative doses of doxorubicin or equivalent exceeding 450 mg/m2 should receive careful risk versus benefit consideration before receiving treatment with Pixuvri.
Maltese: skan ta' multigated radionuclide (MUGA), anormalitajiet kardjovaskulari klinikament sinifikanti (tal-grad 3 jew 4 tal-Assoċjazzjoni tal-Qalb ta' New York [NYHA]), infart mijokardijaku fl-aħħar 6 xhur, arritmija severa, pressjoni għolja mhux ikkontrollata, anġina mhux ikkontrollata, jew dożi kumulattivi preċedenti ta' doxorubicin jew ekwivalenti li jaqbżu l-450 mg/m2, għandhom jiġu kkunsidrati bir-reqqa r-riskji meta mqabbla mal-benefiċċji qabel ma jingħataw kura b'Pixuvri.
English: The occurrence of secondary cancers, including AML and MDS, may occur during or after treatment with Pixuvri.
Maltese: L-okkorrenza ta' kanċer sekondarji, inkluż AML u MDS, jistgħu jseħħu waqt jew wara trattament Pixuvri.
English: After reconstitution with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection, each ml of concentrate contains pixantrone dimaleate equivalent to 5.8 mg pixantrone.
Maltese: Wara r-rikostituzzjoni b'5 ml klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni, kull ml ta' konċentrat fih pixantrone dimaleate ekwivalenti għal 5.8 mg pixantrone.
English: CLINICAL PARTICULARS
Maltese: rilevanza klinika.
English: The results in the rituximab pretreated patients still showed superior treatment benefit with Pixuvri over the comparator for overall response rate (31.6% with Pixuvri versus 17.9% with the comparator) and median progression-free survival (3.3 months with Pixuvri versus 2.5 months with the comparator).
Maltese: Ir-riżultati fil-pazjenti li qabel kienu kkurati b'rituximab xorta urew benefiċċju ogħla bil-kura b'Pixuvri meta mqabbel mal-komparatur għar-rata ta' rispons globali (31.6% b'Pixuvri meta mqabbel ma' 17.9% bil komparatur) u sopravivenza medja mingħajr progressjoni (3.3 xhur b'Pixuvri meta mqabbel ma' 2.5 xhur bilkomparatur).
English: The terminal half-life ranged from 14.5 to 44.8 hr with a mean of 23.3 ± 8.0 (n=14, CV=34%) and a median of 21.2 hr. Due to the limited contribution of renal clearance, plasma clearance is mainly non-renal.
Maltese: 14.5 sa 44.8 sigħat b'medja ta' 23.3 ± 8.0 (n=14, CV=34%) u medja ta' 21.2 siegħa.
English: Lactose monohydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Maltese: Sodium hydroxide (għall-aġġustament tal-pH) Hydrochloric acid (għall-aġġustament tal-pH)
English: How to store Pixuvri
Maltese: Jekk Pixuvri
English: s r.o.
Maltese: U L-UŻU Ċ.
English: The pharmacokinetics of Pixuvri was dose-independent in the 3 mg/m2 to105 mg/m2 dose range and no substantial differences were observed when the medicinal product was given as a single agent or in combination studies.
Maltese: Il-farmakokinetika ta' Pixuvri kienet indipendenti mid-doża fil-medda tad-doża ta' bejn it-3 mg/m2 sa 105 mg/m2 u ma ġiet osservata l-ebda differenza sostanzjali meta l-prodott mediċinali ngħata bħala aġent waħdieni jew fi studji ta' taħlit ta' aġenti.
English: The median overall survival for patients treated with Pixuvri was 2.6 months longer compared to patients treated with comparator (HR=0.79, logrank p=0.25) (see Figure 2 below).
Maltese: Is-sopravvivenza globali medja għall-pazjenti kkurati b'Pixuvri kienet ta' 2.6 xhur aktar meta mqabbla malpazjenti kkurati bil-komparatur (HR=0.79, logrank p=0.25) (ara l-Figura 2 ta' hawn taħt).
English: Each vial contains 50 mg pixantrone dimaleate (equivalent to 29 mg pixantrone).
Maltese: Kull kunjett fih 50 mg pixantrone dimaleate (ekwivalenti għal
English: This medicinal product contains approximately 1000 mg (43 mmol) sodium per dose after dilution.
Maltese: Dan il-prodott mediċinali fih madwar 1000 mg (43 mmol) melħ għal kull doża wara d-dilwizzjoni.
English: Uncommon Hypersensitivity to the medicinal product
Maltese: Sensittività eċċessiva għall-prodott mediċinali
English: Uncommon Dizziness, lethargy
Maltese: Sturdament, letarġija
English: Theophylline: when co-administering the narrow-therapeutic index medicinal product theophylline, which is primarily metabolised by CYP1A2, there is a theoretical concern that this substrate may increase in concentration resulting in theophylline toxicity.
Maltese: Theophylline: meta wieħed jagħti fl-istess waqt il-prodott mediċinali theophylline bl-indiċi terapewtiku żgħir, li huwa primarjament metabolizzat permezz ta' CYP1A2, hemm tħassib teoretiku li dan is-sottostrat jista' jżid fil-konċentrazzjoni u jikkawża tossiċità mit-theophylline.
English: Pixuvri 29 mg powder for concentrate for solution for infusion pixantrone
Maltese: Pixuvri 29 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: After repeated administrations of Pixuvri at doses as low as 0,1 mg/kg/day, a dose-dependent testicular atrophy was detected in the dogs.
Maltese: Wara l-għoti ripetut ta' Pixuvri f'dożi baxxi sa 0,1 mg/kg/kuljum, fil-klieb instabet atrofija testikolari dipendenti mid-doża.
English: Please note:
Maltese: /Tel:
English: Cardiac failure events (MedDRA terms cardiac failure, cardiac failure acute and cardiac failure congestive) occurred in 6 patients (8.8%) treated with Pixuvri (2 patients with grade 1-2, 1 patient with grade 3, and 3 patients, 2 considered as unrelated, with grade 5).
Maltese: seħħew f'6 pazjenti (8.8%) ikkurati b'Pixuvri (2 pazjenti bi grad 1-2, pazjent bi grad 3, u 3 pazjenti,
English: Uncommon Hyperbilirubinaemia, hepatotoxicity
Maltese: Anoressija, ipofosfatemija
English: Progression Free Survival Probability
Maltese: Probabbiltà ta' Sopravvivenza mingħajr Progressjoni
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tat- tessuti konnettivi
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (15°C to 25°C) and daylight exposure in polyethylene (PE) standard infusion bags.
Maltese: L-istabilità kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperatura ambjentali (15°C sa 25°C) u f'espożizzjoni għad-dawl tax-xemx f'boroż tal-infużjoni standard tal-polyethylene (PE).
English: Pixuvri is intended for administration as a slow intravenous infusion using an in-line filter (over a minimum of 60 minutes) only after reconstitution with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection and after further dilution with sodium chloride 9 mg/ml (0.9%) solution for injection to a final volume of 250 ml.
Maltese: Pixuvri huwa maħsub sabiex jingħata bħala infużjoni ġol-vina bil-mod permezz ta' filtru fil-linja (għal tal inqas 60 minuta) biss wara r-rikostituzzjoni b'5 ml ta' klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għallinjezzjoni u wara aktar dilwizzjoni bil-klorur tas-sodju 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni għal volum finali ta' 250 ml.
English: Mechanism of action The active substance of Pixuvri is pixantrone , a cytotoxic aza-anthracenedione.
Maltese: Is-sustanza attiva ta' Pixuvri hija pixantrone, aza-anthracenedione ċitotossiku.
English: This is equivalent to 50% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 50 % tat-teħid fid-dieta massimu ta' kuljum rakkomandat ta' sodju għal adult.
English: Delay treatment until recovery to grade 1.
Maltese: Ittardja l-kura sakemm ikun hemm irkupru għal grad 1.
English: Pixuvri contains sodium
Maltese: Kif jidher Pixuvri u l-kontenut tal-pakkett