FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 768 patients were randomised in a 1:1 ratio to either the panobinostat + bortezomib + dexamethasone (n=387) or the placebo + bortezomib + dexamethasone (n=381) arm, stratified by prior use of bortezomib [Yes (n=336 (43.8%)), No (n=432 (56.3%))] and number of prior lines of anti-myeloma therapy [1 prior line (n=352 (45.8%)), 2 to 3 prior lines (n=416 (54.2%))].
Maltese: Total ta' 768 pazjent kienu randomizzati (randomised) skont proporzjon ta' 1:1 jew fil-grupp mogħti panobinostat + bortezomib + dexamethasone (n=387) jew il-plaċebo + bortezomib + dexamethasone (n=381), stratifikati skont l-użu minn qabel ta' bortezomib [Iva (n=336 (43.8%)), Le (n=432 (56.3%))] u l-għadd ta' linji ta' terapija għal kontra l-mijeloma mogħtija diġà [linja 1 mogħtija minn qabel (n=352 (45.
English: ECOG performance status was 0-1 in 93% of patients.
Maltese: L-istatut tal-ħila ECOG kien ta' 0-1 fi 93% tal-pazjenti.
English: Renal failure, haematuria, urinary incontinence
Maltese: Insuffiċjenza tal-kliewi, ematurija, inkontinenza tal-awrina
English: The median OS was 40.3 months in the panobinostat + bortezomib + dexamethasone arm and 35.8 months in the placebo + bortezomib + dexamethasone arm (Hazard ratio: 0.94 (95% CI: 0.78, 1.14)).
Maltese: L-OS medju kien 40.3 xhur fil-fergħa panobinostat + bortezomib + dexamethasone u 35.8 xhur fil-fegħa plaċebo + bortezomib + dexamethasone (Proporzjon ta' periklu (hazard ratio): 0.94 (95% CI: 0.78, 1.14)).
English: Capsule content
Maltese: U KONTENUT Kapsula iebsa
English: No pharmacokinetic data are available for patients with severe hepatic impairment.
Maltese: M'hemmx informazzjoni farmakokinetika dwar pazjenti b'indeboliment tal-fwied gravi.
English: The frequency category reflects the combination of all the medicinal products i.e. panobinostat + bortezomib + dexamethasone.
Maltese: Il-kategorija ta' frekwenza tirrifletti lkombinazzjoni tal-prodotti mediċinali kollha jiġifieri panobinostat + bortezomib + dexamethasone.
English: CTC grade 3 or 4 haemorrhage was reported in 4.2% of patients, including cases of gastrointestinal and pulmonary haemorrhage with fatal outcomes.
Maltese: Emorraġija b'CTC fi grad 3 jew 4 kienet irrappurtata f'4.2% tal-pazjenti, inkluż każijiet ta' emorraġija gastrointestinali u pulmonari b'konsegwenzi fatali.
English: Patients over 65 years of age had a higher frequency of selected adverse events and of discontinuation of treatment because of adverse events.
Maltese: Pazjenti 'l fuq minn 65 sena kellhom frekwenza akbar ta' ċerti episodji avversi u ta' waqfien tattrattament minħabba reazzjonijiet avversi.
English: CTC grade 3 or 4 haemorrhage was reported in 4.2% of patients, mostly commonly involving gastrointestinal haemorrhage.
Maltese: Emorraġija CTC fi grad 3 jew 4 kienet irrappurtata f'4.2% tal-pazjenti, u kienet tinvolvi l-aktar emorraġija gastrointestinali.
English: Anticipated pharmacodynamic interactions
Maltese: Interazzjonijiet farmakodinamiċi mbassra
English: The median number of prior therapies was 1.0.
Maltese: In-numru medju ta' terapiji mogħtija qabel kien ta' 1.0.
English: In vitro, panobinostat caused the accumulation of acetylated histones and other proteins, inducing cell cycle arrest and/or apoptosis of some transformed cells.
Maltese: In vitro, panobinostat ikkawża l-akkumulazzjoni ta' histones aċetilati u proteini oħrajn, l-induzzjoni ta' arrest taċ-ċiklu taċċelloli u/jew apoptożi ta' xi ċelloli ttrasformati.
English: Strong CYP3A4 inducers
Maltese: Indutturi qawwija ta' CYP3A4
English: QTc prolongation was observed and was mostly mild in degree: QTcF interval >450 msec and ≤480 msec was reported in 10.8% of patients, with maximum increase from baseline >30 msec and ≤60 msec in 14.5% of patients.
Maltese: Kien hemm titwil tal-QTc u ħafna drabi dan kien ħafif: Kien irrappurtat intervall tal-QTcF ta' >450 msek u ≤480 msek f'10.8% tal-pazjenti, b'żieda massima mil-linja bażi ta' >30 msek u ≤60 msek f'14.5% tal-pazjenti.
English: Prolongation of QT interval
Maltese: Titwil tal-intervall tal-QT
English: Five patients (1.3%) died of events associated with haemorrhage.
Maltese: Ħames pazjenti (1.3%) mietu minħabba avvenimenti assoċjati ma' emorraġija.
English: QTcF >480 and <500 msec was recorded in 1.3% of patients and change from baseline of >60 msec was observed in 0.8% of patients.
Maltese: Kienu rreġistrati QTcF ta' >480 u <500 msek f'1.3% tal-pazjenti u kien osservat tibdil mil-linja bażi ta' >60 msek f'0.8% tal-pazjenti.
English: Haemorrhage intracranial, syncope, tremor, dysgeusia
Maltese: Emorraġija intrakranjali, sinkope, tregħid, diżgweżja (dysgeusia)
English: The median age was 63 years, range 28-84; 42.1% of patients were older than 65 years.
Maltese: L-età medja kienet ta' 63 sena, b'medda ta' 28-84; 42.1% tal-pazjenti kellhom aktar minn 65 sena.
English: Strong CYP3A4 inhibitors
Maltese: Inibituri qawwija ta' CYP3A4
English: The panobinostat fraction metabolised through CYP3A4 is approximately 40%.
Maltese: Il-frazzjoni ta' panobinostat immetabolizzata permezz ta' CYP3A4 hi ta' madwar 40%.
English: Approximately 40% of panobinostat is metabolised through CYP3A4.
Maltese: Madwar 40% ta' panobinostat hu mmetabolizzat permezz ta' CYP3A4.
English: Hypothyroidism events were reported in 8 of 381 patients treated with panobinostat + bortezomib + dexamethasone in Study D2308, of whom 2 required treatment.
Maltese: Kienu rrappurtati episodji ta' ipotirojdiżmu fost 8 minn 381 pazjent ittrattati b'panobinostat + bortezomib + dexamethasone waqt l-Istudju D2308, li minnhom tnejn kellhom bżonn trattament.
English: Grade 3
Maltese: Ġimgħa 3
English: - The active substance of Farydak is panobinostat.
Maltese: X'fih Farydak - Is-sustanza attiva ta' Farydak hi panobinostat.
English: Panobinostat has demonstrated mutagenic potential in the Ames assay, endo-reduplication effects in human peripheral blood lymphocytes in vitro, and DNA damage in an in vivo COMET study in mouse lymphoma L5178Y cells, that are attributed to the pharmacological mode of action.
Maltese: Panobinostat wera li għandu potenzjal mutaġeniku waqt l-investigazzjoni Ames, effetti ta'endoriduplikazzjoni (endo-reduplication) fil-limfoċiti taddemm periferali uman in vitro, u li jagħmel ħsara lid-DNA waqt l-istudju COMET in vivo fiċ-ċelloli tal-limfoma L5178Y tal-ġurdien, li huma attribwiti għall-mod ta' azzjoni farmakoloġiku.
English: Most newly occurring severe neutropenia was grade 3 (28%), with considerably fewer cases of grade 4 (6.6%).
Maltese: L-aktar episodji ġodda ta' newtropenija gravi kienu fi grad 3 (28%), b'ħafna anqas każijiet fi grad 4 (6.6%).
English: SGOT (AST) levels
Maltese: TWISSIJA(IET) SPEĊJALI
English: QTcF should be <480 msec prior to initiation of treatment with Farydak.
Maltese: Il-QTcF għandu jkun ta' <480 msek qabel ma jitnieda t-trattament b'Farydak.
English: Other medicines and Farydak
Maltese: Mediċini oħra u Farydak
English: Study DUS71 was a two-stage, single-arm, open-label multicentre phase II study of oral panobinostat (20 mg) in combination with bortezomib (1.3 mg/m2) and dexamethasone (20 mg) in 55 patients with relapsed and refractory multiple myeloma, who were bortezomib-refractory and had received at least two prior lines of therapy.
Maltese: L-istudju DUS71 kien studju multiċentriku f'fażi II f'żewġ stadji, bi trattatment wieħed (single-arm), open-label dwar panobinostat mogħti mill-ħalq (20 mg) flimkien ma' bortezomib (1.3 mg/m2) u dexamethasone (20 mg) f'55 pazjent b'mijeloma multipola rikorrenti u rifrattorja, li kienu rifrattorji b'bortezomib u kienu ngħataw mill-inqas żewġ linji ta' terapija minn qabel.
English: HDACs catalyse the removal of acetyl groups from the lysine residues of histones and some non-histone proteins.
Maltese: L-HDACs jikkatalizzaw it-tneħħija ta' gruppi ta' acetyl mir-residwi ta' lysine tal- histones u xi proteini mhux histone.
English: Clinical efficacy in patients with bortezomib-refractory multiple myeloma (Study DUS71Panorama 2)
Maltese: L-effikaċja klinika f'pazjenti b'mijeloma multipla bortezomib-rifrattorja (Studju DUS71
English: Liver function should be monitored prior to treatment and regularly during treatment.
Maltese: Il-funzjoni tal-fwied għandha tkun immonitorata qabel it-trattament u b'mod regolari matul ittrattament.
English: In the overall patient population PFS based on the full analysis set (FAS) was statistically significantly different between the treatment arms (stratified Log-rank test p<0.0001, with an estimated 37% risk reduction in the panobinostat + bortezomib + dexamethasone arm compared to the placebo + bortezomib + dexamethasone arm (Hazard ratio: 0.63 (95% CI: 0.52, 0.76)).
Maltese: Fil-popolazzjoni sħiħa ta' pazjenti, il-PFS imsejjes fuq sett ta' analiżi sħiħa (full analysis set FAS) kienstatistikament differenti b'mod sinifikanti bejn ilgruppi mogħtija t-trattament (stratified Log-rank test p<0.0001, bi tnaqqis tar-riskju stmat li kien 37% fil-grupp mogħti panobinostat + bortezomib + dexamethasone imqabbel mal-grupp mogħti plaċebo + bortezomib + dexamethasone (Proporzjon ta' periklu (hazard ratio): 0.63 (95% CI: 0.52, 0.76)).
English: Bortezomib may be started at 1.3 mg/m2 once weekly on days 1 and 8, and dexamethasone at 20 mg on days 1 and 8.
Maltese: Bortezomib jista' jinbeda b'1.3 mg/m2 darba fil-ġimgħa fl-1el u t-8n ġurnata, u dexamethasone b'20 mg fl-1el u t-8n ġurnata.
English: This could potentially lead to slightly decreased exposure to sensitive CYP3A4 substrates.
Maltese: Dan jista' potenzjalment iwassal għal espożizzjoni kemmxejn imnaqqsa għal sottostrati sensittivi ta' CYP3A4.
English: • chills
Maltese: • Tqala
English: Progression-free survival Median, months [95% CI] Hazard ratio [95% CI]1
Maltese: Proporzjon ta' periklu [95% CI]1
English: Localised and systemic infections, including pneumonia, other bacterial infections, invasive fungal infections such as aspergillosis or candidiasis, and viral infections including hepatitis B virus and herpes simplex, have been reported in patients taking panobinostat.
Maltese: Infezzjonijiet lokalizzati u sistemiċi, inkluż pulmonite, infezzjonijiet batteriċi oħrajn, infezzjonijiet invażivi bil-fungu bħal asperġillożi jew kandidjasi, u infezzjonijiet virali, inklużi l-virus tal-epatite B u herpes simplex, kienu rrappurtati f'pazjenti li qed jieħdu.
English: Reduce bortezomib dose to 0.7 mg/m2 in the first treatment cycle.
Maltese: bortezomib għal 0.7 mg/m2 fl-ewwel ċiklu ta' trattament.
English: It is not known whether panobinostat is dialysable.
Maltese: Mhux magħruf jekk panobinostat huwiex dijalizzabbli.
English: Clinical efficacy in patients with relapsed and relapsed and refractory multiple myeloma (Study D2308 - Panorama 1)
Maltese: L-effikaċja klinika f'pazjenti b'mijeloma multipla rikorrenti u rikorrenti u rifrattorja (Studju D2308
English: Number of patients at risk
Maltese: Numru ta‘ pazjenti f‘riskju
English: The median duration of follow-up was 28.75 months in the panobinostat + bortezomib + dexamethasone arm and 29.04 months in the placebo + bortezomib + dexamethasone arm.
Maltese: Id-dewmien medju ta' follow-up kien ta' 28.75 xhur għall-grupp mogħti panobinostat + bortezomib + dexamethasone u ta' 29.04 xhur għall-grupp mogħti plaċebo + bortezomib + dexamethasone.
English: 20.7% of patients experienced haemorrhage, most frequently epistaxis (4.7%), haematoma (2.6%), and conjunctival haemorrhage (2.1%).
Maltese: Bosta mill-pazjenti bi tromboċitopenija ma kellhom l-ebda emorraġija. 20.7% tal-pazjenti kellhom emorraġija, l-aktar frekwenti jkunu epistassi (4.7%), ematoma (2.6%), u emorraġija konġuntivali (2.1%).
English: After a single oral dose of [14C] panobinostat in patients, 29 to 51% of administered radioactivity is excreted in the urine and 44 to 77% in the faeces.
Maltese: Wara doża orali singola ta' [14C] panobinostat fil-pazjenti, minn 29 sa 51% tar-radjuattività tgħaddi mal-awrina u bejn 44 u 77% mal-ippurgar.
English: Tabulated list of adverse drug reactions from clinical studies
Maltese: Lista ttabulata ta' reazzjonijiet avversi tal-mediċina minn studji kliniċi
English: One Farydak blister = 3 weeks = 1 cycle
Maltese: Folja waħda b'Farydak = 3 ġimgħat = ċiklu 1
English: Haemorrhage has been reported in patients during treatment with panobinostat.
Maltese: Kienet irrappurtata emorraġija f'pazjenti matul it-trattament b'panobinostat.
English: Day 5
Maltese: Tabella 5
English: Unchanged panobinostat accounted for <2.5% of the dose in urine and <3.5% of the dose in faeces.
Maltese: L-ammont ta' panobinostat mhux mittiefes kien ta' <2.5% tad-doża fl-awrina u ta' <3.5% tad-doża fl-ippurgar.
English: Figure 1 Median platelet counts over time (Study D2308, Safety set, cycles 1-8)
Maltese: Figura 1 L-għadd medju ta' plejtlits matul il-medda taż-żmien (Studju D2308, Sett tas sigurtà, ċikli 1-8)
English: The safety data of panobinostat have been assessed from a total of 451 patients with multiple myeloma treated with panobinostat in combination with bortezomib and dexamethasone and from a total of 278 patients treated with panobinostat as a single agent.
Maltese: Id-dejta tas-sigurtà ta' panobinostat ġiet evalwata minn total ta' 451 pazjent b'mijeloma multipla ttrattati b'panobinostat flimkien ma' bortezomib u dexamethasone u minn total ta' 278 pazjent ittrattati b'panobinostat bħala aġent waħdieni.
English: Day 2
Maltese: Dublin 2
English: Patients received panobinostat (20 mg taken orally once a day, three times per week, on a 2 weeks on and 1 week off dosing regimen), in combination with bortezomib (1.3 mg/m2 injected intravenously) and dexamethasone (20 mg).
Maltese: Il-pazjenti ngħataw panobinostat (20 mg meħuda mill-ħalq darba kuljum, tliet darbiet fil-ġimgħa, b'reġim ta' dożaġġ, ta' ġimagħtejn iva u ġimgħa le), flimkien ma' bortezomib (1.3 mg/m2 injettati minn ġol-vina) u dexamethasone (20 mg).
English: QT prolongation and ECG abnormalities
Maltese: Titwil tal-QT u anormalitajiet fl-ECG
English: Magnesium stearate Mannitol
Maltese: Il-kontenut tal-kapsula Magnesium stearate
English: No patient had an absolute QTcF >500 msec.
Maltese: Ma kienx irrappurtat QTcF ta' >500 msek f'xi pazjent.
English: In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, including, but not limited to, ketoconazole, itraconazole, voriconazole, ritonavir, saquinavir, telithromycin, posaconazole and nefazodone, the dose of panobinostat should be reduced to 10 mg (see section 4.5).
Maltese: F'pazjenti li jieħdu prodotti mediċinali konkomitanti li huma inibituri qawwija ta' CYP3A u/jew Pgp, inklużi, iżda mhux limitati għal, ketoconazole, itraconazole, voriconazole, ritonavir, saquinavir, telithromycin, posaconazole u nefazodone, id-doża ta' panobinostat għandha titnaqqas għal 10 mg (ara sezzjoni 4.5).
English: Mild hypothyroidism was reported in patients treated with panobinostat + bortezomib + dexamethasone in Study D2308; some patients required treatment (see section 4.4).
Maltese: Ġie rrapportat ipotirojdiżmu ħafif f'pazjenti li ngħataw trattament b'panobinostat + bortezomib + dexamethasone fl-Istudju D2308; xi pazjenti kienu jeħtieġu trattament (ara sezzjoni 4.4).
English: • If QT prolongation is unresolved within 7 days, treatment should be discontinued.
Maltese: • Jekk it-titwil tal-QT ma jissolviex fi żmein 7t ijiem, it-trattament għandu jitwaqqaf.
English: Very common Decreased appetite, hypophosphataemia a, hyponatraemia a, hypokalaemia a
Maltese: Nuqqas ta' aptit, ipofosfatemija a, iponatremija a, ipokalemija a
English: ECG (electrocardiogram) abnormalities have been reported in patients treated with panobinostat + bortezomib + dexamethasone, mainly involving ST-T depression (21.7%) and T wave changes (39.6%).
Maltese: Kienu rrapportati anormalitajiet fl-ECG (elettrokardjogramm) f'pazjenti ttrattati b'panobinostat + bortezomib + dexamethasone, l-aktar dawk li jinvolvu dipressjoni ST-T (21.7%) u bidliet fil-mewġa T (39.6%).
English: PAN=panobinostat BTZ= bortezomib Dex = dexamethasone
Maltese: BTZ= bortezomib Dex = dexamethasone
English: In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, including, but not limited to, ketoconazole, itraconazole, voriconazole, ritonavir, saquinavir, telithromycin, posaconazole and nefazodone, the dose of panobinostat should be reduced (see section 4.2).
Maltese: F'pazjenti li jieħdu flimkien prodotti mediċinali li huma inibituri qawwija ta' CYP3A u/jew Pgp, inkluż, imma mhux biss, ketoconazole, itraconazole, voriconazole, ritonavir, saquinavir, telithromycin, posaconazole u nefazodone, id-doża ta' panobinostat għandha titnaqqas (ara sezzjoni 4.2).
English: No data is available that can be used to exclude the risk that panobinostat could be a weak inducer of the enzyme CYP3A4 in the gastrointestinal tract.
Maltese: Ma hija disponibbli ebda informazzjoni li tista' tintuża sabiex teskludi r-riskju li panobinostat jista' jkun induttur dgħajjef tal-enzima CYP3A4 fil-passaġġ gastrointestinali.
English: Blood and lymphatic system disorders a
Maltese: Disturbi tad-demm u tassistema limfatika a
English: Treatment was administered for a maximum of 16 cycles (see Tables 1 and 2).
Maltese: It-trattament ingħata għal massimu ta' 16-il ċiklu (ara Tabelli 1 u 2).
English: The baseline platelet count should be ≥100 x 109/l and the baseline absolute neutrophil count (ANC) ≥1.0 x 109/l.
Maltese: L-għadd tal-plejtlits fil-linja bażi għandu jkun ta' ≥100 x 109/l u l-għadd assolut ta' newtrofili fil-linja bażi (ANC) ta' ≥1.0 x 109/l.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX42
Maltese: Aġenti antineoplastiċi oħrajn, Kodiċi ATC:
English: Each hard capsule contains panobinostat lactate anhydrous equivalent to 20 mg panobinostat.
Maltese: Kull kapsula iebsa fiha l-panobinostat lactate anhydrous ekwivalenti għal 20 mg panobinostat.
English: If a dose reduction is required, the dose of panobinostat should be reduced by decrements of 5 mg (i.e. from 20 mg to 15 mg or from 15 mg to 10 mg).
Maltese: Jekk ikun hemm bżonn li titnaqqas id-doża, id-doża ta' panobinostat għandha titnaqqas bil-mod il-mod b'5 mg kull darba (jiġifieri minn 20 mg għal 15 mg jew minn 15 mg għal 10 mg).
English: Very common Pancytopenia, thrombocytopenia, anaemia, leukopenia, neutropenia, lymphopenia
Maltese: Panċitopenija, tromboċitopenija, anemija, lewkopenija, newtropenija, limfopenija
English: Adverse reactions observed were consistent with the safety profile, with events primarily involving haematological and gastrointestinal disorders such as thrombocytopenia, pancytopenia, diarrhoea, nausea, vomiting and anorexia.
Maltese: Ir-reazzjonijiet avversi osservati kienu konsistenti mal-profil ta' sigurtà, bl-episodji jinvolvu primarjament disturbi ematoloġiċi u gastrointestinali fosthom tromboċitopenija, panċitopenija, dijarea, dardir, rimettar u anoressija.
English: • Patient information pack
Maltese: • Pakkett Informattiv għall-Pazjent
English: A total of 53.0% of patients were male.
Maltese: Total ta' 53.0% tal-pazjenti kienu rġiel.
English: In addition, increased expression of the tumour suppressor gene p21CDKNIA (cyclin dependent kinase inhibitor 1/p21) gene, a key mediator of G1 arrest and differentiation, was triggered with panobinostat exposure.
Maltese: Barra minn hekk, minħabba l-espożizzjoni għal panobinostat kien hemm żieda fl-espressjoni tal-ġene suppressur tat-tumur p21CDKNIA (ċiklin li jiddependi fuq l-inibitur tal-kinasi 1/p21 - cyclin dependent kinase inhibitor 1/p21), medjatur ewlieni tal-arrest u d-differenzazzjoni tal-GI,.
English: On-treatment deaths not due to the study indication (multiple myeloma) were reported in 6.8% of panobinostat + bortezomib + dexamethasone-treated patients versus 3.2% of placebo + bortezomib + dexamethasone-treated patients.
Maltese: Kienu rrappurtati mwiet waqt it-trattament mhux minħabba l-indikazzjoni tal-istudju (mijeloma multipla) f'6.8% tal-pazjenti ttrattati b'panobinostat + bortezomib + dexamethasone kontra 3.2% talpazjenti ttrattati bi plaċebo + bortezomib + dexamethasone.
English: Farydak is an anti-cancer medicine that contains the active substance panobinostat, which belongs to a group of medicines called pan-deacetylase inhibitors.
Maltese: Farydak hu mediċina għal kontra l-kanċer li fih is-sustanza attiva panobinostat, li tagħmel parti minn grupp ta' mediċini msejħa inibitur pan-deacetylase.
English: Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.
Maltese: Farydak, flimkien ma' bortezomib u dexamethasone, hu indikat għat-trattament ta' pazjenti adulti b'mijeloma multipla li rkadew jew ma fiqux wara li diġà ngħataw mill-inqas żewġ reġimi li jinkludu bortezomib u aġent immunomodulatorju.
English: QTcF should be <480 msec prior to initiation of treatment with panobinostat (see below section on dose adjustments and section 4.4).
Maltese: Il-QTcF għandhu jkun ta' <480 msek qabel it-tnedija tat-trattament b'panobinostat (ara t-taqsima ta' hawn taħt dwar l-aġġustament tad-doża u s-sezzjoni 4.4).
English: Skin lesions, rash, erythema
Maltese: Feriti fuq il-ġilda, raxx, eritema
English: Table 4 Recommended dose modifications for gastrointestinal toxicity Adverse drug reaction
Maltese: Tabella 4 Tibdil tad-doża rrakkomandata f'każ ta' tossiċità gastrointestinali
English: The other ingredients are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze.
Maltese: Is-sustanzi l-oħra huma: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze.
English: Mild and moderate hepatic impairment as per NCI-CTEP classification increased panobinostat plasma exposure by 43% and 105%, respectively.
Maltese: L-indeboliment talfwied bejn ħafif u moderat skont il-klassifikazzjoni NCI-CTEP żied l-espożizzjoni ta' panobinostat filplażma bi 43% u 105%, rispettivament.
English: The other ingredients are: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze.
Maltese: Is-sustanzi l-oħra huma: magnesium stearate, mannitol, microcrystalline cellulose, pregelatinised starch, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac glaze.
English: Respiratory failure, rales, wheezing, epistaxis
Maltese: Insuffiċjenza respiratorja, ħsejjes fil-pulmun, tħarħir, epistassi
English: Adverse drug reactions from the phase III study (Panorama 1) are shown in Table 7.
Maltese: Ir-reazzjonijiet avversi tal-mediċina fi studju f'fażi III (Panorama 1) huma murija f'Tabella 7.
English: Pooled clinical data from over 500 patients treated with panobinostat alone in multiple indications and at different dose levels have shown that the incidence of CTC grade 3 QTc prolongation (QTcF >500 msec) was approximately 1% overall and 5% or more at a dose of 60 mg or higher; no episodes of torsades de pointes were observed.
Maltese: Skont dejta klinika miġbura minn fost aktar minn 500 pazjent ittrattati b'panobinostat waħdu f'indikazzjonijiet multipli u b'dożi f'livelli differenti ntwera li l-inċidenza ta' titwil tal-QTc b'CTC fi grad 3 (QTcF >500 msek) kienet ta' madwar 1% fuq kollox u ta' 5% jew aktar b'doża ta' 60 mg jew ogħla; ma kienx hemm episodji ta' torsades de pointes.
English: Farydak bortezomib and dexamethasone N=73
Maltese: Farydak bortezomib u dexamethasone
English: - Each Farydak 20 mg hard capsule contains 20 mg panobinostat.
Maltese: - Kull kapsula iebsa tal-20 mg Farydak fiha 20 mg panobinostat.
English: Hazard Ratio= 0.47
Maltese: N=74
English: Carcinogenesis and mutagenesis
Maltese: Karċinoġenesi u mutaġenesi