FrancophonIA/ELRC3.0 huggingface dataset:
English: A clinical study in cancer patients with impaired hepatic function showed that plasma exposure of panobinostat increased by 43% (1.4-fold) and 105% (2-fold) in patients with mild and moderate hepatic impairment, respectively.
Maltese: Studju kliniku f'pazjenti bil-kanċer b'funzjoni empatika indebolita wera li l-espożizzjoni tal-plażma għal panobinostat żdiedet bi 43% (1.4 drabi aktar) u b'105% (darbtejn aktar) f'pazjenti b'indeboliment tal-fwied ħafif u moderat, rispettivament.
English: The effect of renal impairment on the pharmacokinetics of panobinostat was assessed in a phase I study in 37 patients with advanced solid tumours with varying degrees of renal function.
Maltese: L-effet tal-indeboliment tal-kliewi fuq il-farmakokinetika ta' panobinostat kien evalwat fi studju f'fażi I, f'37 pazjent b'tumuri solidi avvanzati u bi gradi varji ta' indeboliment tal-kliewi.
English: Each hard capsule contains panobinostat lactate anhydrous equivalent to 15 mg panobinostat.
Maltese: Kull kapsula iebsa fiha l-panobinostat lactate anhydrous ekwivalenti għal 15 mg panobinostat.
English: In patients with platelet count <50 x 109/l (complicated by bleeding) or <25 x 109/l, Farydak therapy should be withheld and resumed at a reduced dose upon recovery to platelet count ≥50 x 109/l.
Maltese: F'pazjenti bl-għadd tal-plejtlits <50 x 109/l (ikkumplikat bi fsada) jew <25 x 109/l, it-terapija b'Farydak għandha titwaqqaf u titkompla b'doża mnaqqsa wara li lpazjent jirkupra għal għadd ta' plejtlits ≥50 x 109/l.
English: The most common adverse events (AEs) leading to treatment discontinuation were diarrhoea (4.5%), asthenia and fatigue (2.9% each) and pneumonia (1.3%).
Maltese: L-aktar episodji avversi komuni (AEs) li jwasslu biex jitwaqqaf għal kollox tat-trattament kienu d-dijarea (4.5%), l-astenja u l-għeja (2.9% kull wieħed) u l-pulmonite (1.3%).
English: All 55 patients were previously treated with bortezomib and at least one IMiD (lenalidomide: 98.2%, thalidomide: 69.1%).
Maltese: 98.2%, thalidomide: 69.1%).
English: Reproduction toxicity
Maltese: Tossiċità tar-riproduzzjoni
English: The efficacy and safety of panobinostat in combination with bortezomib and dexamethasone were evaluated in a randomised, double-blind, placebo-controlled, multicentre phase III study in patients with relapsed or relapsed and refractory multiple myeloma who had received 1-3 prior lines of therapies.
Maltese: III randomizzat (randomised), double-blind, ikkontrollat bil-plaċebo f'pazjenti b'mijeloma multipla rikorrenti jew rikorrenti u rifrattorja li diġà ngħataw 1-3 linji ta' terapiji.
English: Based on non-clinical findings, male fertility may be compromised by treatment with Farydak (see section 5.3).
Maltese: Skont riżultati mhux kliniċi, il-fertilità fir-raġel tista' tkun affettwata negattivament waqt it-trattament b'Farydak (ara sezzjoni 5.3).
English: Figure 2 Kaplan-Meier plot of progression-free survival in patients with multiple myeloma who received at least two prior regimens including bortezomib and an immunomodulatory agent
Maltese: Figure 2 Struttura Kaplan-Meier ta' sopravivenza ħielsa minn kwalunkwe progressjoni f'pazjenti bi mjeloma multipla li ngħataw mill-inqas żewġ reġimi minn qabel li jinkludu bortezomib u aġent immunomodulatorju
English: Diarrhoea Grade 2 despite anti-diarrhoeal medicinal product
Maltese: Dijarea Grad 2 minkejja l-prodott mediċinali għal kontra d-dijarea
English: In the subgroup of patients who had received at least two prior regimens including bortezomib and an immunomodulatory agent (n=147), the overall response rate using modified EBMT criteria was 59% in the panobinostat + bortezomib + dexamethasone arm and 39% in the placebo + bortezomib + dexamethasone arm.
Maltese: Fis-sottogrupp ta' pazjenti li ngħataw mill-inqas żewġ reġimi minn qabel li jinkludu bortezomib kif ukoll 'aġent immunomodulatorju (n=147), ir-rata ta' rispons ġenerali bl-użu ta' kriterji EBMT modifikati kienet ta' 59% fil-grupp mogħti panobinostat + bortezomib + dexamethasone u 39% filgrupp mogħti plaċebo + bortezomib + dexamethasone.
English: - Each Farydak 15 mg hard capsule contains 15 mg panobinostat.
Maltese: - Kull kapsula iebsa tal-15 mg Farydak fiha 15 mg panobinostat.
English: Treatment-emergent haematological toxicities included thrombocytopenia, anaemia, neutropenia and lymphopenia.
Maltese: It-tossiċitajiet ematoloġiċi li ġew mit-trattament kienu jinkludu tromboċitopenija, anemija, newtropenija u limfopenija.
English: Strong inducers are expected to have greater effects, and may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum), should be avoided.
Maltese: Hu mistenni li indutturi qawwija jkollhom effetti akbar, u jistgħu jnaqqsu l-effikaċja ta' panobinostat, u għalhekk l-użu flimkien ta' indutturi qawwija ta' CYP3A4 li jinkludu, imma mhux biss, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin u St.
English: Table 7 Panobinostat adverse drug reactions observed in multiple myeloma patients in the phase III study
Maltese: Tabella 7 Ir-reazzjonijiet avversi tal-mediċina li fiha panobinostat osservati f'pazjenti b'mijeloma multipla fi studju f'fażi III Sistema tal-Klassifika talOrganu
English: 33.3% patients in the panobinostat + bortezomib + dexamethasone arm and 10.3% patients in the placebo + bortezomib + dexamethasone arm received platelet transfusions during treatment.
Maltese: 3% tal-pazjenti fil-grupp mogħti plaċebo + bortezomib + dexamethasone ngħataw trasfużjonijiet ta' plejtlits matul it-trattament.
English: 1 dose omitted
Maltese: Tikek ħomor
English: Each hard capsule contains panobinostat lactate anhydrous equivalent to 10 mg panobinostat.
Maltese: Kull kapsula iebsa fiha l-panobinostat lactate anhydrous ekwivalenti għal 10 mg panobinostat.
English: In this subset of patients (N=147), the median duration of treatment was 4.5 months in the panobinostat + bortezomib + dexamethasone arm and 4.8 months in the placebo + bortezomib + dexamethasone arm.
Maltese: F'dan is-sottogrupp ta' pazjenti (N=147), it-tul medju ta' trattament kien ta' 4.5 xhur filgrupp mogħti panobinostat + bortezomib + dexamethasone u ta' 4.8 xhur fil-grupp mogħti plaċebo + bortezomib + dexamethasone.
English: Prior to launch of Farydak in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Farydak f'kull Stat Membru d-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel dwar il-kontenut u l-format tal-programm edukattiv, inkluż dwar il-mezzi ta' komunikazzjoni, il-modalitajiet ta' distribuzzjoni, u kull aspett ieħor tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: For patients experiencing severe adverse drug reactions other than thrombocytopenia, gastrointestinal toxicity, neutropenia or QTc prolongation, the recommendation is the following:
Maltese: F'każ ta' pazjenti li qed ikollhom reazzjonijiet avversi gravi għall-mediċina minbarra ttromboċitopenija, it-tossiċità gastrointestinali, in-newtropenija jew it-titwil tal-QTc, irrakkomandazzjoni hi din li ġejja:
English: • oral thrush (yeast infection of the mouth)
Maltese: • thrush orali (infezzjoni tal-ħmira tal-ħalq)
English: Printing ink
Maltese: Pressjoni baxxa
English: • CTC grade 2 toxicity recurrence or CTC grades 3 and 4 - omit the dose until recovery to CTC
Maltese: • Tossiċità rikorrenti ta' CTC fi grad 2 jew CTC fi gradi 3 u 4 - tiħux id-doża sakemm ma tirkuprax għal CTC fi grad ≤1 u kompli bit-trattament b'doża mnaqqsa.
English: In clinical studies in multiple myeloma, the exposure of panobinostat was decreased by approximately 20% by the concomitant use of dexamethasone, which is a dose-dependent mild/moderate CYP3A4 inducer.
Maltese: Fi studji kliniċi dwar il-mijeloma multipla, l-espożizzjoni ta' panobinostat niżlet b'madwar 20% bl-użu flimkien ta' dexamethasone, li hu induttur ħafif/moderat ta' CYP3A4 dipendenti fuq id-doża.
English: Caucasians comprised 65.0% of the study population, Asians 30.2% and blacks 2.9%.
Maltese: Il-Kawkażjatiċi kienu jammontaw għal 65.0% talpopolazzjoni tal-istudju, l-Ażjatiċi 30.2% u s-suwed 2.9%.
English: Platelets <50 x 109/l with bleeding
Maltese: <50 x 109/l bi fsada
English: Refractoriness to bortezomib was defined as disease progression on or within 60 days of the last bortezomib-containing line of therapy.
Maltese: Ir-rifrattorizzazzjoni għal bortezomib kienet definata bħala progressjoni tal-marda sas-60 jum jew fi żmien 60 jum mill-aħħar linja ta' terapija
English: • blood in urine (a sign of a kidney problem)
Maltese: • demm fl-awrina (sinjal ta' problema fil-kliewi)
English: Grade 3 asthenia was observed in 9.4% of the patients, with no patients experiencing asthenia at CTC grade 4.
Maltese: Astenja fi grad 3 dehret f'9.4% tal-pazjenti, bl-ebda pazjent ma jkollu astenja skont CTC fi grad 4.
English: Likewise ischaemic heart disease (including myocardial infarction and ischaemia) were reported in 4.5% of patients with ST-T depression and 4.8% of patients with T wave change and 2.7% of patients with neither of these ECG abnormalities.
Maltese: Bl-istess mod, kien irrapportat mard iskemiku talqalb (inklużi infart mijokardjali u iskemija) f'4.5% tal-pazjenti b'dipressjoni ST-T u f'4.8% talpazjenti b'bidliet fil-mewġa T, kif ukoll fi 2.7% tal-pazjenti b'ebda waħda minn dawn l-anormalitajiet fl-ECG.
English: Liver function tests
Maltese: Testijiet tal-funzjoni tal-fwied
English: Table 2 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 9-16).
Maltese: Tabella 2 Skeda rrakkomandata għat-teħid ta' Farydak flimkien ma' bortezomib u dexamethasone (ċikli 9-16).
English: Panobinostat represented 6 to 9% of the drug-related exposure in plasma.
Maltese: Panobinostat irrappreżenta 6 sa 9% tal-espożizzjoni fil-plażma b'rabta mal-mediċina.
English: Farydak 15 mg capsules panobinostat
Maltese: IL-PRODOTT MEDIĊINALI Farydak 15 mg kapsuli panobinostat
English: Joint swelling
Maltese: Shellac glaze
English: Table 1 Recommended dosing schedule of panobinostat in combination with bortezomib and dexamethasone (cycles 1-8)
Maltese: Tabella 1 Skeda tad-doża rrakkomandata ta' panobinostat flimkien ma' bortezomib u dexamethasone (ċikli 1-8)
English: Abnormal values should be corrected as clinically indicated (see section 4.4).
Maltese: Il-valuri anormali għandhom ikunu korretti kif indikat klinikament (ara sezzjoni 4.4).
English: Thyroid function tests
Maltese: Testijiet tal-funzjoni tat-tirojde
English: Panobinostat has not been studied in patients with end-stage renal disease (ESRD) or patients on dialysis (see section 5.2).
Maltese: Panobinostat ma ġiex studjat f'pazjenti morda bil-kliewi fl-aħħar stadju (end-stage renal disease ESRD) jew f'pazjenti fuq dijaliżi (ara sezzjoni 5.2).
English: Table 1 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 1-8)
Maltese: Tabella 1 Skeda rrakkomandata għat-teħid ta' Farydak flimkien ma' bortezomib u dexamethasone (ċikli 1-8)
English: Therefore, medicinal products that can influence CYP3A4 enzyme activity may alter the pharmacokinetics of panobinostat.
Maltese: Għaldaqstant, il-prodotti mediċinali li jistgħu jinfluwenza l-attività tal-enzima CYP3A4 jistgħu jwasslu biex tinbidel il-farmakokinetika ta' panobinostat.
English: In patients with hepatic impairment receiving concomitant medicinal products which are strong CYP3A4 inhibitors, treatment with panobinostat should be avoided due to lack of experience and safety data in this patient population.
Maltese: F'pazjenti b'indeboliment tal-fwied li qed jingħataw prodotti mediċinali konkomitanti li huma inibituri qawwija ta' CYP3A4, għandu jiġi evitat trattament b'panobinostat minħabba n-nuqqas ta' esperjenza u informazzjoni dwar is-sigurtà f'din il-popolazzjoni ta' pazjenti.
English: 1 Hazard ratio obtained from stratified Cox model
Maltese: 1 Proporzjon ta' periklu miksub mill-mudell stratifikat Cox
English: Panobinostat has a terminal elimination half-life of approximately 37 hours based on final parameters estimate in the population PK analysis.
Maltese: Panobinostat għandu half-life tal-eliminazzjoni terminali ta' madwar 37 siegħa skont l-istima tal-parametri finali tal-analiżi talpopolazzjoni PK.
English: Farydak 10 mg hard capsules
Maltese: Farydak 10 mg kapsuli iebsa
English: Gastrointestinal toxicity is very common in patients treated with panobinostat.
Maltese: It-tossiċità gastrointestinali hi komuni ħafna f'pazjenti ttrattati b'panobinostat.
English: Electrocardiographic changes
Maltese: Tibdiliet elettrokardjografiċi
English: Hyperglycaemia, dehydration, hypoalbuminaemia, fluid retention, hyperuricaemia, hypocalcaemia, hypomagnesaemia
Maltese: Ipergliċemija, deidrazzjoni, ipoalbuminemija, żamma ta' fluwidu, iperurikemija, ipokalċemija, ipomanjeżemija
English: More than half (57.2%) of the patients had undergone prior stem cell transplantation and 62.8% of the patients were relapsed after previous anti-neoplastic therapies (e.g. melphalan 79.6%, dexamethasone 81.1%, thalidomide 51.2%, cyclophosphamide 45.3%, bortezomib 43.0%, combined bortezomib and dexamethasone 37.8%, lenalidomide 20.4%).
Maltese: Aktar minn nofs (57.2%) talpazjenti kellhom trapjant taċ-ċelloli staminali qabel u 62.8% tal-pazjenti kellhom rikaduta wara terapiji antineoplastiċi preċedenti (e.g. melphalan 79.6%, dexamethasone 81.
English: Platelet counts should be monitored prior to each dose of bortezomib (i.e. on days 1, 4, 8 and 11 of cycles 1-8, see Table 1, and on days 1 and 8 of cycles 9-16, see Table 2).
Maltese: L-għadd tal-plejtlits għandu jkun evalwat qabel kull doża ta' bortezomib (jiġifieri fil-jiem 1, 4, 8 u 11 taċ-ċikli 1-8, ara Tabella 1, u fil-jiem 1 u 8 taċ-ċikli 9-16, ara Tabella 2).
English: Increased levels of acetylated histones were observed in xenografts from mice that were treated with panobinostat.
Maltese: Ġiet osservata żieda fil-livelli ta' histonesaċetilati fi xenografts minn ġrieden li kienu ttrattati b'panobinostat.
English: Farydak 20 mg hard capsules
Maltese: Farydak 20 mg kapsuli iebsa
English: Anti-emetic medicinal products with a known risk of QT prolongation such as dolasetron, granisetron, ondansetron and tropisetron should be used with caution (see section 4.4).
Maltese: Il-prodotti antiemitiċi b'riskju magħruf li jtawlu l-QT fosthom dolasetron, granisetron, ondansetron u tropisetron għandhom jintużaw b'kawtela (ara sezzjoni 4.4).
English: Take the pack and this leaflet with you.
Maltese: Ħu miegħek il-pakkett u dan il-fuljett.
English: - Do not store above 30°C.
Maltese: - Taħżinx f'temperatura 'l fuq minn 30°C.
English: Farydak 15 mg hard capsules
Maltese: Farydak 15 mg kapsuli iebsa
English: - medicines used to treat hypertension, such as metoprolol or nebivolol.
Maltese: - Tarmix mediċini mal-ilma tad-dranaġġ.
English: Oxidative metabolism of panobinostat played a less prominent role, with approximately 40% of the dose eliminated by this pathway.
Maltese: Il-metaboliżmu ossidattiv ta' panobiunostat kellu sehem anqas prominenti, b'madwar 40% tad-doża eliminata minn din il-mogħdija.
English: Haematological adverse drug reactions, including severe thrombocytopenia, neutropenia and anaemia (CTC grade 3 to 4) were reported in patients treated with panobinostat.
Maltese: Kienu rrappurtati reazzjonijiet avversi ematoloġiċi minħabba l-mediċina fost il-pazjentili kienu qed jieħdu panobinostat, inkluż troboċitopenija, newtropenija u anemija gravi (CTC fi grad 3 sa 4).
English: - Each Farydak 10 mg hard capsule contains 10 mg panobinostat.
Maltese: - Kull kapsula iebsa tal-10 mg Farydak fiha 10 mg panobinostat.
English: Strong inducers may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin and St. John's Wort (Hypericum perforatum), should be avoided (see section 4.5).
Maltese: Indutturi qawwija jistgħu jnaqqsu l-effikaċja ta' panobinostat, għalhekk, l-użu -istess ħin ta' indutturi qawwija ta' CYP3A4 inkluż, iżda mhux limitat għal, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin u St.
English: Farydak 20 mg capsules panobinostat
Maltese: IL-PRODOTT MEDIĊINALI Farydak 20 mg kapsuli panobinostat
English: Anti-emetic medicinal products with a known risk of QT prolongation such as dolasetron, granisetron, ondansetron and tropisetron should be used with caution (see section 4.5).
Maltese: Il-prodotti antiemitiċi b'riskju magħruf li jtawlu l-QT fosthom dolasetron, granisetron, ondansetron u tropisetron għandhom jintużaw b'kawtela (ara sezzjoni 4.5).
English: Co-administration of a single 20 mg panobinostat dose with ketoconazole, a strong CYP3A inhibitor, increased the Cmax and AUC of panobinostat by 1.6- and 1.8-fold, respectively, compared to when panobinostat was given alone.
Maltese: L-għoti flimkien ta' doża waħda ta' 20 mg panobinostat ma' ketocanzole, inibitur qawwi ta' CYP3A, żied is-Cmax u l-AUC ta' panobinostat b'1.6 u 1.8 drabi, rispettivament, imqabbel ma' meta panobinostat ingħata waħdu.
English: Petechiae
Maltese: Mistrieħ
English: EU/1/15/1023/001 6 capsules
Maltese: EU1/15/1023/006 24 kapsula
English: Cardiac events (most frequently atrial fibrillation, tachycardia, palpitation and sinus tachycardia) were reported in 17.6% of panobinostat + bortezomib + dexamethasone-treated patients versus 9.8% of placebo + bortezomib + dexamethasone-treated patients and syncope events were reported in 6.0% versus 2.4%, respectively.
Maltese: 6% tal-pazjenti ttrattati b'panobinostat + bortezomib + dexamethasone kontra 9.8% tal-pazjenti ttrattati bi plaċebo + bortezomib + dexamethasone u kienu rrapportati avvenimenti ta' sinkope f'6.0% kontra 2.4%, rispettivament.
English: Additional blood counts should be considered during the “rest period” - e.g. on days 15 and/or 18, especially in patients ≥65 years and patients with a baseline platelet count below 150 x 109/l.
Maltese: Għandu jiġi kkunsidrat għadd ta' demm addizzjonali matul il-“perjodu ta' mistrieħ” - eż. fil-jiem 15 u/jew 18, speċjalment f'pazjenti ≥65 sena u pazjenti b'għadd ta' plejtlits fil-linja bażi inqas minn 150 x 109/l.
English: Farydak 10 mg hard capsules Farydak 15 mg hard capsules Farydak 20 mg hard capsules
Maltese: Farydak 10 mg kapsuli iebsa Farydak 15 mg kapsuli iebsa Farydak 20 mg kapsuli iebsa panobinostat
English: The effect of hepatic impairment on the pharmacokinetics of panobinostat was evaluated in a phase I study, in 24 patients with solid tumours and with varying degrees of hepatic impairment.
Maltese: L-effet tal-indeboliment tal-fwied fuq il-farmakokinetika ta' panobinostat kien evalwat fi studju f'fażi I, f'24 pazjent b'tumuri solidi u bi gradi varji ta' indeboliment tal-fwied.
English: The recommended dose of bortezomib is 1.3 mg/m2 given as an injection.
Maltese: Id-doża rrakkomandata ta' bortezomib hi ta' 1.3 mg/m2 mogħtija bħala injezzjoni.
English: If continuous treatment with a strong CYP3A4 inhibitor is required, a dose escalation from 10 mg to 15 mg panobinostat may be considered based on patient tolerability.
Maltese: Jekk ikun meħtieġ trattament kontinwu b'inibitur qawwi ta' CYP3A4, tista' tiġi kkunsidrata żieda tad-doża minn 10 mg għal 15 mg ta' panobinostat skont it-tollerabbiltà tal-pazjent.
English: No episodes of QTcF prolongation >500 msec were reported with the dose of 20 mg Farydak in the phase III clinical study, in combination with bortezomib and dexamethasone.
Maltese: Ma kinux irrappurtati episodji ta' titwil tal-QTcF b'>500 msek b'doża ta' 20 mg Farydak waqt studju kliniku f'fażi
English: • abdominal pain, diarrhoea, swelling or bloating of the abdomen (signs of inflamed stomach lining)
Maltese: • uġigħ fl-addome, dijarea, nefħa fl-addome (sinjali ta' infjammazzjoni fir-rita tal-istonku)
English: Farydak 10 mg capsules panobinostat
Maltese: IL-PRODOTT MEDIĊINALI Farydak 10 mg kapsuli panobinostat
English: Panobinostat shows more cytotoxicity towards tumour cells compared to normal cells.
Maltese: Panobinostat juri aktar ċitotossiċità lejn iċċelloli ta' tumur, imqabbla maċ-ċelloli normali.
English: • diarrhoea, abdominal pain, fever (signs of an inflamed colon)
Maltese: • dijarea, uġigħ fl-addome, deni (sinjali ta' infjammazzjoni fil-musrana)
English: Appropriate monitoring of electrolytes (e.g. potassium, magnesium and phosphorus) and ECG should be performed at baseline and periodically during treatment, particularly in patients with severe gastrointestinal adverse drug reaction (see section 4.2).
Maltese: Għandu jkun hemm monitoraġġ xieraq tal-elettroliti (eż. potassju, manjeżju u fosfru) u jsir ECG fillinja bażi u b'mod regolari matul it-trattament, b'mod partikulari f'pazjenti b'reazzjoni avversa għallmediċina gastrointestinali gravi (ara sezzjoni 4.2).
English: Bortezomib dose on recovery to ≤ grade 1
Maltese: bortezomib meta l pazjent jirkupra għal ≤ grad 1
English: Hepatotoxicity
Maltese: Newtropenija
English: Thyroid and pituitary function should be monitored by measuring hormone levels (e.g. free T4 and TSH) as clinically indicated (see section 4.2).
Maltese: Għandu jkun hemm monitoraġġ tal-funzjoni tat-tirojde u l-glandola pitwitarja billi jitkejlu l-livelli ormonali (eż. free T4 u TSH) kif indikat klinikament (ara sezzjoni 4.2).
English: After oral administration, panobinostat pharmacokinetics appear to be linear in the dose range 10-30 mg, but AUC increases less than proportionally with dose at higher doses.
Maltese: Wara l-għoti mill-ħalq, il-farmakokinetika ta' panobinostat jidher li kienet lineari malfirxa tad-doża ta' 10-30 mg, imma l-AUC jiżdied anqas milli proporzjonalment b'doża mogħtija skont dożi ogħla.
English: Placebo bortezomib and dexamethasone N=74
Maltese: Plaċebo bortezomib u dexamethasone
English: • feeling tired (fatigue), pale skin.
Maltese: • tħossok għajjien, ġilda pallida.
English: Table 3 Recommended dose modifications for thrombocytopenia Thrombocytopenia grade on day of treatment
Maltese: Tabella 3 Tibdil tad-doża rrakkomandat għal tromboċitopenija
English: Any
Maltese: Xejn
English: Day 10 Day 11 Day 12 Day 13 Day 14 Day 15 Day 16 Day 17 Day 18 Day 19 Day 20 Day 21
Maltese: Jekk jogħġbok irreferi għat-Tabella 1 għaċ-ċikli minn 1 sa 8 u t-Tabella 2 għaċ-ċikli minn 9 sa
English: Embryo foetal lethality and increases in skeletal anomalies (extra sternabrae, extra ribs, increases in minor skeletal variations, delayed ossification and variations of the sternabrae) were seen above exposures corresponding to 0.25 of the human clinical AUC.
Maltese: Ġew osservati mwiet tal-embrijuni u l-fetu u żidiet f'anomaliji skelettriċi (sternabrae żejda, kustilji żejda, żidiet f''varjazzjonijiet skelettriċi minuri, dewmien fl-ossifikazzjoni u varjazzjonijiet tal-isternabrae) 'il fuq minn espożizzjonijiet li jikkorrespondu għal 0.25 tal-AUC kliniku uman.
English: • The dose should be omitted, if QTcF is ≥480 msec or above 60 msec from baseline.
Maltese: • Id-doża għandha titwaqqaf, jekk il-QTcF ikun ta' ≥480 msek jew aktar minn 60 msek mil-linja bażi.
English: If this is unavoidable, patients should be closely monitored and further dose reduction or discontinuation may be considered as clinically indicated (see section 4.5).
Maltese: Jekk dan ikun inevitabbli, il-pazjenti għandhom jiġu mmonitorjati mill-qrib u jista' jiġi kkunsidrat li d-doża tkompli titnaqqas jew titwaqqaf skont kif indikat klinikament (ara sezzjoni 4.5).
English: Overall survival (OS) was the key secondary endpoint.
Maltese: Is-sopravivenza ġenerali (overall survival - OS) kienet l-endpoint ewlieni sekondarju.
English: Treatment of tumour cells with panobinostat resulted in a dose-dependent increase in acetylation of histones H3 and H4 both in vitro and in xenograft animal pre-clinical models, demonstrating target inhibition.
Maltese: It-trattament taċ-ċelloli tat-tumur b'panobinostat wassal għal żieda dipendenti fuq id-doża talaċetilazzjoni (acetylation) tal-histones H3 u H4 t-tnejn li huma in vitro u f'mudelli mhux kliniċi xenograft ta' annimali, li juru inibizzjoni tat-target.