FrancophonIA/ELRC3.0 huggingface dataset:
English: 11 of 16 patients were successfully treated (at the end of treatment complete or partial resolution of signs and symptoms present at baseline) with posaconazole oral suspension 800 mg/day in divided doses for a median of 296 days and up to 460 days.
Maltese: 11 minn 16-il pazjent kienu kkurati b'suċċess (fi tmiem il-kura kellhom fejqan sħiħ jew parzjali missinjali u s-sintomi li kien hemm fil-linja bażi) bi 800 mg/jum tas-suspensjoni orali ta' posaconazole f'dożi maqsumin għal perjodu medjan ta' 296 jum u sa 460 jum.
English: pulmonary embolism, deep vein thrombosis
Maltese: • ħolm stramb, jew diffikultà biex torqod
English: Frequent monitoring for adverse reactions and toxicity related to calcium channel blockers is recommended during co-administration with posaconazole.
Maltese: Huwa rakkomandat monitoraġġ frekwenti għar-reazzjonijiet avversi u t-tossiċità relatati malimblokkaturi tal-kanali tal-kalċju waqt l-għoti fl-istess ħin ma' posaconazole.
English: Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjonijiet 5.1 u 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: The microbiological data suggest that posaconazole is active against Rhizomucor, Mucor, and Rhizopus; however the clinical data are currently too limited to assess the efficacy of posaconazole against these causative agents.
Maltese: It-tagħrif mikrobijoloġiku jissuġġerixxi li posaconazole huwa attiv kontra Rhizomucor, Mucor, u Rhizopus; madankollu t-tagħrif kliniku għadu limitat wisq biex tiġi valutata l-effikaċja ta' posaconazole kontra dawn l-aġenti kawżattivi.
English: Sixteen patients 8-17 years of age were treated with posaconazole oral suspension 800 mg/day in a study for invasive fungal infections.
Maltese: Sittax-il pazjent b'etajiet minn 8-17-il sena kienu kkurati b'800 mg/jum tas-suspensjoni orali ta' posaconazole fi studju dwar infezzjonijiet fungali invażivi.
English: Monitoring of patients with severe renal impairment Due to the variability in exposure, patients with severe renal impairment should be monitored closely for breakthrough fungal infections (see sections 4.2 and 5.2).
Maltese: Monitoraġġ ta' pazjenti b'indeboliment renali sever Minħabba l-varjabbiltà fl-esponiment, il-pazjenti b'indeboliment renali sever għandhom jiġu ssorveljati mill-qrib għal infezzjonijiet fungali li jfiġġu minkejja l-kura (ara sezzjonijiet 4.2 u 5.2).
English: Patient management should include laboratory evaluation of hepatic function (particularly liver function tests and bilirubin).
Maltese: Limaniġġar tal-pazjenti għandu jinkludi evalwazzjoni permezz ta' laboratorju tal-funzjoni epatika (l aktar testijiet tal-funzjoni tal-fwied u bilirubin).
English: Vinca alkaloids
Maltese: Alkalojdi vinka
English: c: In 1899, this was the period from randomisation to 100 days post-randomisation; in 316 it was the period from the baseline day to 111 days post-baseline.
Maltese: Fl-Istudju 1899, dan kien il-perjodu mill-għażla aleatorja sa 100 jum wara l-għażla aleatorja; fl-Istudju 316 dan kien il perjodu mill-jum fil-linja bażi sa 111-il jum wara l-linja bażi.
English: In a study of 136 neutropenic paediatric patients 11 months - 17 years treated with posaconazole oral suspension at doses up to 18 mg/kg/day divided TID, approximately 50% met the pre-specified target (Day 7 Cav between 500 ng/mL-2,500 ng/mL).
Maltese: TID maqsuma, madwar 50% ssodisfaw il-mira speċifikata minn qabel (Ġurnata 7 Cav bejn 500 ng/mL-2,500 ng/mL).
English: 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Polysorbate 80
English: However, in clinical efficacy trials, the safety profile of posaconazole between the young and elderly patients was similar.
Maltese: Madankollu, il-profil tas-sigurtà ta' posaconazole bejn individwi Suwed u Kawkasi kien simili.
English: Type I glass vial closed with bromobutyl rubber stopper and aluminium seal containing 16.7 mL of solution.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett tal-ħġieġ tat-tip I magħluq b'tapp tal-gomma bromobutyl u siġill tal-aluminju li fih 16.7 mL
English: Co-administration of posaconazole with CYP3A4 substrates may result in large increases in exposure to CYP3A4 substrates as exemplified by the effects on tacrolimus, sirolimus, atazanavir and midazolam below.
Maltese: L-għoti fl-istess ħin ta' posaconazole ma' substrati ta' CYP3A4 jista' jwassal għal żidiet kbar fl-esponiment għas-substrati ta' CYP3A4 kif muri milleffetti fuq tacrolimus, sirolimus, atazanavir u midazolam aktar 'l isfel.
English: Due to the variability in exposure, patients with severe renal impairment should be monitored closely for breakthrough fungal infections (see section 4.2).
Maltese: Minħabba l-varjabbiltà fl-esponiment, ilpazjenti b'indeboliment renali sever għandhom jiġu ssorveljati mill-qrib għal infezzjonijiet fungali li għadhom jiġu skoperti (ara sezzjoni 4.2).
English: Noxafil 300 mg concentrate for solution for infusion posaconazole
Maltese: Noxafil 300 mg/konċentrat għal soluzzjoni għall-infużjoni posaconazole
English: Concomitant use of posaconazole and phenytoin and similar inducers (e.g. carbamazepine, phenobarbital, primidone) should be avoided unless the benefit to the patient outweighs the risk.
Maltese: L-użu fl-istess ħin ta' posaconazole u phenytoin u indutturi simili (eż. carbamazepine, phenobarbital, primidone) għandu jiġi evitat sakemm il-benefiċċju għall-pazjent ma jkunx jegħleb irriskju.
English: Race There is insufficient data among different races with posaconazole tablets.
Maltese: M'hemmx dejta suffiċjenti bejn razez differenti bil-pilloli ta' posaconazole.
English: This should be taken into consideration by patients on a controlled sodium diet.
Maltese: Dan għandu jitqies minn pazjenti fuq dieta ta' sodium ikkontrollat.
English: Cardiac disorders Uncommon:
Maltese: • Candida parapsilosis:
English: Multiple, time-matched ECGs collected over a 12 hour period were obtained before and during administration of posaconazole oral suspension (400 mg twice daily with high fat meals) from 173 healthy male and female volunteers aged 18 to 85 years.
Maltese: Ħafna ECGs imqabbla bil-ħin, li nġabru fuq perjodu ta' 12-il siegħa, kienu miksuba qabel u waqt lgħoti tas-suspensjoni orali ta' posaconazole (400 mg darbtejn kuljum ma' ikliet b'kontenut għoli ta' xaħam) minn 173 voluntiera rġiel u nisa b'saħħithom b'etajiet minn 18 sa 85 sena.
English: Meropenem
Maltese: Tfal
English: • through a plastic tube placed in your vein (intravenous infusion)
Maltese: • permezz ta' tubu tal-plastik imqiegħed ġol-vina (infużjoni ġol-vina)
English: long QT syndrome
Maltese: • Preżenza ta' arritmiji bis-sintomi
English: Posaconazole plasma concentrations following administration of posaconazole tablets may increase over time in some patients (see section 5.2).
Maltese: Ilkonċentrazzjonijiet fil-plażma ta' posaconazole wara l-għoti ta' posaconazole jistgħu jiżdiedu mażżmien f'xi pazjenti (ara sezzjoni 5.2).
English: Do not use Noxafil
Maltese: Tużax Noxafil
English: In healthy volunteers under fasting conditions, dividing the total daily dose (800 mg) into 200 mg four times daily compared to 400 mg twice daily, was shown to increase posaconazole exposure by 2.6-fold.
Maltese: F'voluntiera b'saħħithom fl-istat sajjem, meta d-doża tal-jum (800 mg) kienet maqsuma f'200 mg erba' darbiet kuljum imqabbel ma' 400 mg darbtejn kuljum, intwera li l-esponiment ta' posconazole żdied b'2.6-il darba.
English: Each mL of oral suspension contains 40 mg of posaconazole.
Maltese: Kull mL tas-suspensjoni orali fiha 40 mg ta' posaconazole.
English: The excreted metabolites in urine and faeces account for approximately 17 % of the administered radiolabelled dose of posaconazole oral suspension.
Maltese: Il-metaboliti li jitneħħew fl-awrina u flippurgar jammontaw għal madwar 17 % tad-doża radjutikkettata li tingħata ta' posaconazole suspensjoni orali.
English: How to store Noxafil
Maltese: Sejjer tingħata Noxafil:
English: • a blockage in your gut (intestinal obstruction) especially in the “ileum”.
Maltese: • sadd fl-imsaren (ostruzzjoni intestinali) speċjalment fl-“ileu”.
English: • ciclosporin (used during or after transplant surgery)
Maltese: • ciclosporin (jintuża meta issir kirurġija ta' trapjant jew wara)
English: A. fumigatus
Maltese: • stitikezza
English: Clinical success rate was defined as the number of cases assessed as having a clinical response (cure or improvement) divided by the total number of cases eligible for analysis.
Maltese: Rata ta' suċċess kliniku kienet definita bħala n-numru ta' każijiet meqjusa li għandhom rispons kliniku (fejqan jew titjib) diviż man-numru totali ta' każijiet eliġibbli għall-analiżi.
English: Measuring spoon
Maltese: Indeboliment tal-fwied
English: • medicines used to decrease stomach acid such as cimetidine and ranitidine or omeprazole and similar medicines that are called proton pump inhibitors.
Maltese: • mediċini li jintużaw biex inaqqsu l-aċidu fl-istonku bħal cimetidine u ranitidine jew omeprazole u mediċini simili li jissejħu impedituri tal-pompi tal-protoni.
English: Gender The pharmacokinetics of posaconazole are comparable in men and women.
Maltese: Il-farmakokinetika tal-pilloli ta' posaconazole hija komparabbli fl-irġiel u n-nisa.
English: • mental problems such as hearing voices or seeing things that are not there
Maltese: • problemi mentali bħal smigħ ta' vuċijiet jew tara ħwejjeġ li ma jkunux hemm
English: The use of combination antifungal therapies should not decrease the efficacy of either posaconazole or the other therapies; however, there is currently no clinical evidence that combination therapy will provide an added benefit.
Maltese: L-użu ma' terapiji kontra l- fungu m'għandux inaqqas l-effikaċja la ta' posaconazole u l-anqas tatterapiji l-oħra; iżda bħalissa m'hemmx evidenza klinika li terapija kombinata tipprovdi xi benefiċċju addizzjonali.
English: See “Other medicines and Noxafil” below for information on other medicines which may interact with Noxafil.
Maltese: Ara “Mediċini oħra u Noxafil” hawn isfel għal informazzjoni dwar mediċini oħra li jistgħu jinteraġixxu ma' Noxafil.
English: 93055 Regensburg Germany
Maltese: 93055 Regensburg
English: August 2021
Maltese: Awwissu 2021
English: 4879 AC Etten-Leur Netherlands
Maltese: 4879 AC Etten-Leur L-Olanda
English: 1105 BP Amsterdam Netherlands
Maltese: 1105 BP Amsterdam L-Olanda
English: Incyte Biosciences Distribution B.V. Paasheuvelweg 25
Maltese: Incyte Biosciences Distribution B.V.
English: alanine aminotransferase aspartate aminotransferase
Maltese: aspartate aminotransferase
English: Ponatinib is highly bound (> 99%) to plasma proteins in vitro.
Maltese: Ponatinib jintrabat b'mod qawwi (> 99%) ma' proteini fil-plażma in vitro.
English: itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit juice.
Maltese: ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, u meraq tal-grejpfrut.
English: Maintained MCyR
Maltese: McyR
English: See section 2 “Iclusig contains lactose”.
Maltese: Ara sezzjoni 2 “Iclusig fih il-lactose”.
English: • The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 4000, polyvinyl alcohol, titanium dioxide (E171).
Maltese: • Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica (colloidal anhydrous), magnesium stearate, talc, macrogol 4000, polyvinyl alcohol, titanium dioxide (E171).
English: *ANC = absolute neutrophil count
Maltese: *ANC = absolute neutrophil count - l-għadd assolut ta' newtrofili
English: The most common serious adverse reactions >2% (treatment-emergent frequencies) were pneumonia (7.3%), pancreatitis (5.8%), abdominal pain (4.7%), atrial fibrillation (4.5%), pyrexia (4.5%), myocardial infarction (4.0%), peripheral arterial occlusive disease (3.8%), anaemia (3.8%), angina pectoris (3.3%), platelet count decreased (3.1%), febrile neutropenia (2.9%), hypertension (2.9%), coronary artery disease (2.7%), cardiac failure congestive (2.4%), cerebrovascular accident (2.4%), sepsis (2.4%), cellulitis (2.2%), acute kidney injury (2.0%), urinary tract infection (2.0%) and lipase increased (2.0%).
Maltese: L-aktar reazzjonijiet avversi komuni serji ta' >2% (frekwenzi li dehru mal-kura) kienu pnewmonja (7.3%), pankreatite (5.8%), uġigħ addominali (4.7%), fibrillazzjoni tal-atriju (4.5%), deni (4.5%), infart mijokardijaku (4.0%), mard okklużiv arterjaliperiferiku (3.8%), anemija, (3.8%), anġina pektoris (3.3%), tnaqqis fl-għadd tal-plejtlits (3.1%), newtropenija bid-deni (2.9%), pressjoni għolja (2.9%), mard tal-arterja koronarja (2.7%), insuffiċjenza konġestiva tal-qalb (2.4%), inċident ċerebrovaskulari (2.4%), sepsis (2.4%), ċellulite (2.2%), ħsara akuta fil-kliewi (2.0%), infezzjoni fis-sistema urinarja (2.0%) u żieda fil-lipase (2.0%).
English: Severe Cutaneous Adverse Reactions (SCARs)
Maltese: Severi tal-Ġilda (SCARs, Severe Cutaneous Adverse Reactions)
English: Iclusig has been evaluated in safety pharmacology, repeat-dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity studies.
Maltese: Iclusig ġie evalwat fi studji ta' sigurtà farmakoloġika, tossiċità dovuta għal dożi ripetuti, ġenotossiċità tossiċità riproduttiva, studji ta' fototossiċità u karċinoġeniċità.
English: *Reported using National Cancer Institute Common Terminology Criteria for Adverse Events version
Maltese: *Rapportaġġ skont in-Cancer Institute Common Terminology Criteria għal Każijiet Avversi verżjoni 4.0.
English: Persistent grade 2 (longer than 7 days)
Maltese: Grad 2 persistenti (itwal minn 7 ijiem)
English: amylase alkaline phosphatase gamma-glutamyltransferase
Maltese: alkaline phosphatase fid-demm, żieda ta' gamma-glutamyltransferase
English: 60 tablets
Maltese: 30 pillola
English: Maintained MMR
Maltese: MMR
English: Database cutoff date 06 February 2017.
Maltese: Data ta' riferiment għad-database 06 ta' Frar 2017.
English: For the overall CP-CML disease group, the probability of survival at 2, 3, 4, and 5 years is estimated as 86.0%, 81.2%, 76.9%, and 73.3%, respectively, as shown in Figure 1.
Maltese: Għall-grupp ta' mard ta' CP-CML b'mod globali, il-probabbiltà ta' sopravvivenza fi 2, 3, 4 u 5 snin hija stmata li hi 86.0%, 81.2%, 76.9%, u 73.3%, rispettivament, kif inhu muri fil-Figura 1.
English: Elevation of AST or ALT ≥ 3 × ULN concurrent with an elevation of bilirubin > 2 × ULN and alkaline phosphatase < 2 × ULN
Maltese: Livelli ogħla ta' AST or ALT ≥ 3 × ULN b'livelli ogħla fl-istess ħin ta' bilirubina > 2 × ULN u alkaline phosphatase < 2 × ULN
English: After a minimum follow-up of 64 months, the rates of adverse reactions resulting in discontinuation were 20% in CP-CML, 11% in AP-CML, 15% in BP-CML and 9% in Ph+ ALL.
Maltese: Wara segwitu minimu ta' 64 xahar, ir-rati ta' reazzjonijiet avversi li wasslu għal twaqqif kienu 20% f'CP-CML, 11% f'AP-CML u 15% f'BP-CML u 9% f'Ph+ ALL.
English: *ULN = Upper Limit of Normal for the lab
Maltese: *IULN = institution upper limit of normal
English: Of the CP-CML patients previously treated with one, two, three or four prior TKIs, 75% (12/16), 68% (66/97), 44% (63/142), and 58% (7/12)) achieved a MCyR while on Iclusig, respectively.
Maltese: Mill-pazjenti b'CP-CML li kienu ngħataw il-kura preċedenti b'TKI wieħed, tnejn, tlieta jew erba', 75% (12/16), 68% (66/97), 44% (63/142) u 58% (7/12) rispettivament kisbu MCyR waqt li kienu fuq Iclusig.
English: Ponatinib is not a substrate for the human organic anion transporting polypeptides OATP1B1, OATP1B3 and the organic cation transporter OCT-1.
Maltese: Ponatinib mhuwiex sottostrat għall-polipeptidi organiċi umani li jġorru l-anjoni, OATP1B1 u OATP1B3 u għat-trasportatur organiku tal-katajoni, OCT-1.
English: A MCyR at the 3-month landmark correlated strongly and statistically significantly with PFS and OS (p<0.0001 and p=0.0006, respectively).
Maltese: Tragward ta' 3 xhur ta' MCyR kien jirrelata b'mod qawwi u b'mod statistikament sinjifikanti ma' PFS u OS (p<0.0001 u p=0.0006, rispettivament).
English: Ponatinib inhibits the activity of other clinically relevant kinases with IC50 values below 20 nM and has demonstrated cellular activity against RET, FLT3, and KIT and members of the FGFR, PDGFR, and VEGFR families of kinases.
Maltese: Ponatinib jimpedixxi l-attività ta' kinases rilevanti oħra b'valuri ta' IC50 taħt 20 nM u wera attività ċellulari kontra RET, FLT3, u KIT u l-membri tal-familji ta' kinases ta' FGFR, PDGFR, u VEGFR.
English: Figure 1- Kaplan-Meier estimates for overall survival in the CP-CML population (Treated Population)
Maltese: Figura 1 - stimi għas-sopravivvenza globali fil-popolazzjoni ta' CP-CML (Popolazzjoni Ttrattata)
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE24
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, impedituri tal-proteina kinase, Kodiċi ATC:
English: Iclusig may result in elevation in ALT, AST, bilirubin, and alkaline phosphatase.
Maltese: Iclusig jista' jirriżulta f'livelli ogħla ta' ALT, AST, bilirubin u, alkaline phosphatase.
English: ≥ 12 month reduction at 30 mg 8 ≥ 18 month reduction at 30 mg 7 ≥ 24 month reduction at 30 mg 6 ≥ 36 month reduction at 30 mg 1 Any dose reduction to 15 mg ≥ 3 month reduction at 15 mg
Maltese: ≥ 3 xhur ta' tnaqqis għal 30 mg ≥ 6 xhur ta' tnaqqis għal 30 mg ≥ 12-il xahar ta' tnaqqis għal 30 mg ≥ 18-il xahar ta' tnaqqis għal 30 mg ≥ 24 xahar ta' tnaqqis għal 30 mg ≥ 36 xahar ta' tnaqqis għal 30 mg
English: Resistant or Intolerant
Maltese: Intolleranti
English: Table 2 Dose modifications for pancreatitis and elevation of lipase/amylase Grade 2 pancreatitis and/or asymptomatic elevation of lipase/amylase
Maltese: Tabella 2 Modifikazzjonijiet fid-doża għal pankreatite u żieda ta' lipase/amylase
English: 90 tablets
Maltese: 30 pillola 90 pillola
English: Frequency categories are very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 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 mill-informazzjoni disponibbli).
English: b CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils < 5% in peripheral blood, No extramedullary involvement (including no hepatomegaly or splenomegaly).
Maltese: b CHR: WBC ≤ ULN instituzzjonali, ANC ≥1,000/mm3, plejtlits ≥100,000/mm3, nuqqas ta' blasts jew promajeloċiti fid-demm periferali, blasts fil-mudullun ≤ 5%, < 5% majeloċiti flimkien ma'
English: The geometric mean (CV%) Cmax and AUC(0-τ) exposures achieved for ponatinib 45 mg daily at steady state were 77 ng/mL (50%) and 1296 ng•hr/mL (48%), respectively.
Maltese: AUC(0-τ) miksuba għal ponatinib 45 mg kuljum fl-istadju fiss kienu 77 ng/mL (50%) u 1296 ng•hr/mL
English: Achieved MCyR at 45 mg (N=86)
Maltese: MCyR milħuq b'45 mg (N=86)
English: Date of latest renewal: 8 February 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 1 ta' Lulju 2013 Data tal-aħħar tiġdid: 8 ta' Frar 2018
English: Ponatinib is a potent pan BCR-ABL inhibitor with structural elements, including a carbon-carbon triple-bond, that enable high affinity binding to native BCR-ABL and mutant forms of the ABL kinase.
Maltese: Ponatinib huwa impeditur qawwi għal pan BCR-ABL b'elementi strutturali, li jinkludu bond tripliku ta' karbonju-karbonju, li jippermetti affinità għolja għal BCR-ABL nattivi u għamliet mutanti tal-kinase ABL.
English: Majora (MaHR)
Maltese: Ematoloġiku Maġġuria (MaHR)
English: The risk of arterial occlusive events is likely to be dose-related.
Maltese: Ir-riskju ta' avvenimenti okklussivi arterjali x'aktarx li huwa relatat mad-doża.
English: All patients (N=449)
Maltese: Pazjenti kollha (N=449)
English: Iclusig 15 mg film-coated tablets Iclusig 30 mg film-coated tablets Iclusig 45 mg film-coated tablets ponatinib
Maltese: Iclusig 15 mg pilloli miksija b'rita Iclusig 30 mg pilloli miksija b'rita Iclusig 45 mg pilloli miksija b'rita
English: A prior MCyR or better (MCyR, MMR, or CMR) to dasatinib or nilotinib was only achieved in 26% patients with CP-CML and a prior MaHR or better (MaHR, MCyR, MMR, or CMR) was only achieved in 21%, and 24% of AP-CML, and BP-CML/Ph+ALL patients, respectively.
Maltese: MCyR minn qabel jew aħjar (MCyR, MMR, jew CMR) għal dasatinib jew nilotinib inkiseb biss f'26% tal-pazjenti b'CP-CML u Mahrminn qabel jew aħjar (MaHR, MCyR, MMR, jew CMR) kien miksub biss f'21% u 24% tal-pazjenti b'AP-CML, u BP-CML/Ph+ ALL,
English: Arterial occlusion and venous thromboembolism
Maltese: Okklużjoni arterjali u tromboemboliżmu venuż
English: The frequency of Grade 3 or 4 thrombocytopenia, neutropenia, and anaemia was higher in patients with AP-CML and BPCML/Ph+ ALL than in patients with CP-CML (see Table 5).
Maltese: Il-frekwenza ta' tromboċitopenja, newtropenja, u anemija ta' Grad 3 jew 4 kienet ogħla f'pazjenti b'AP-CML u BP-CML/Ph+ ALL milli f'pazjenti b'CP-CML (ara Tabella 5).
English: Dose modifications for neutropenia (ANC* < 1.0 x 109/L) and thrombocytopenia (platelet < 50 x 109/L) that are unrelated to leukaemia are summarized in Table 1.
Maltese: Majelosoppressjoni Modifikazzjonijiet fid-doża għal newtropenija (ANC* < 1.0 x 109/L) u tromboċitopenija (plejtlet
English: R/I
Maltese: NUMRU(I)
English: Aneurysms and artery dissections
Maltese: Okklużjoni arterjali
English: Prior TKI therapy- number of regimens, n (%)
Maltese: Terapija minn Qabel b'TKI-numru ta' programmi ta' kura, n (%)
English: Each film-coated tablet contains 120 mg of lactose monohydrate.
Maltese: Kull pillola miksija b'rita fiha 120 mg ta' lactose monohydrate.
English: Iclusig 30 mg film-coated tablets EU/1/13/839/006
Maltese: Iclusig 30 mg pilloli miksija b'rita EU/1/13/839/006
English: Defined as a ≤ 0.1% ratio of BCR-ABL to ABL transcripts on the International Scale (IS) (ie, ≤ 0.1% BCR-ABLIS; patients must have the b2a2/b3a2 (p210) transcript),
Maltese: Imfisser bħala proporzjon ta' ≤ 0.1% ta' BCR-ABL għal traskrizzjonijiet t'ABL fuq l-Iskala Internazzjonali (IS) (ie, ≤ 0.1% BCR-ABL IS; il-pazjenti għandhom jkollhom l-b2a2/b3a2 (traskrizzjoni ta' (p210)), fid-demm periferali mkejjel bil-quantitative reverse transcriptase polymerase chain reaction (qRT PCR).
English: Table 10 Vascular occlusive first adverse events in CP-CML patients who achieved MCyR at 45 mg or 30 mg (data extraction 7 April 2014) Most recent dose at onset of first vascular occlusive Event 45 mg
Maltese: Tabella 10 L-ewwel avvenimenti avversi okklussivi vaskulari f'pazjenti b'CP-CML li kisbu MCyR b'45 mg jew 30 mg (estrazzjoni tad-dejta 7 ta' April 2014)
English: The median time to MaHR in patients with AP-CML, BP-CML, and Ph+ ALL was 0.7 months (range: 0.4 to 5.8 months), 1.0 months (range: 0.4 to 3.7 months), and 0.7 months (range: 0.4 to 5.5 months),
Maltese: Iż-żmien medjan għal MaHR f'pazjenti b'AP-CML, BP-CML, u Ph+ ALL kien ta' 0.7 xhur (firxa: 0.4 sa 5.8 xhur), 1.0 xahar (firxa: 0.4 sa 3.7 xhur), u 0.7 xhur (firxa: 0.4 sa 5.5 xhur), rispettivament.
English: BCR-ABL mutation detected at entry, n (%)b None a* of 427 patients reporting prior TKI therapy with dasatinib or nilotinib b Of the patients with one or more BCR-ABL kinase domain mutations detected at entry, 37 unique mutations were detected.
Maltese: BCR-ABL mutazzjoni misjuba fid-dħul, n (%)b Xejn a* minn 427 pazjent li rraportaw qabel terapija b'TKI b' dasatinib jew nilotinib b Mill-pazjenti b'mutazzjoni waħda jew aktar ta' BCR-ABL fid-dominju ta' kinase osservati mad-dħul, ġew osservati 37 mutazzjoni unika.
English: Occurrence at 30 mg:
Maltese: F'każ ta' 30 mg: