FrancophonIA/ELRC3.0 huggingface dataset:
English: The presence of free Yttrium (90Y) chloride in the body after an inadvertent administration of Ytracis will lead to increase bone marrow toxicity and haematopoetic stem cell damage.
Maltese: IŜ-Ŝewā organi prinëipali fejn Yttrium chloride (90Y) jiddistribwixxi ruħu, huma l-fwied u l-għadam.
English: No interaction studies have been performed.
Maltese: Ma sarux studji dwar l-interazzjonijiet.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Maltese: Prodott mediëinali jingħata b'riëetta ristretta tat-tabib (Ara Anness I : Sommarju tal- Karatteristiëi talProdott, sezzjoni 4.2).
English: Do not use YTRACIS: - if you are hypersensitive (allergic) to Yttrium (90Y) chloride or any of the other ingredients of
Maltese: - jekk inti tbati minn sensittività eëëessiva (allerāiku) għall-Yttrium chloride (90Y) jew sustanzi l oħra ta' YTRACIS.
English: YTRACIS is a radiopharmaceutical precursor.
Maltese: Mhux applikabbli.
English: EMA/675530/2015 EMEA/H/C/001177
Maltese: EMEA/H/C/001177
English: Sycrest asenapine
Maltese: Sycrest asenapina
English: The Y-MRS rates the severity of symptoms of manic episodes on a scale from 0 to 60.
Maltese: Il-Y-MRS tikklassifika s-severità tas-sintomi ta' episodji manijaċi fuq skala minn 0 sa 60.
English: The active substance in Sycrest, asenapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Sycrest, l-asenapina, hija mediċina antipsikotika.
English: Other information about Sycrest:
Maltese: Informazzjoni oħra dwar Sycrest:
English: It is available as sublingual tablets (5 and 10 mg).
Maltese: Jiġi bħala pilloli għal taħt l-ilsien (5 u 10 mg).
English: This summary was last updated in 10-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10-2015.
English: The full EPAR for Sycrest can be found on the Agency's website under EMA website/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Sycrest jista' jinstab fis-sit web tal-Aġenzija taħt EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Sycrest.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Sycrest.
English: The reductions for the second shortterm study were 10.8 and 12.6 points for Sycrest and olanzapine, respectively, and 5.5 for placebo.
Maltese: 8 u 12.6 punti għal Sycrest u l-olanzapina, rispettivament, u 5.5 għal plaċebo.
English: In the first shortterm study, the reductions in Y-MRS score after three weeks were 11.5 and 14.6 points for Sycrest and olanzapine, respectively, compared with 7.8 points for placebo.
Maltese: Fl-ewwel studju fuq perjodu ta' żmien qasir, it-tnaqqis fil-punteġġ ta' Y-MRS wara tliet ġimgħat kien 11.5 u 14.6 punti għal Sycrest u l-olanzapina, rispettivament, meta mqabbel ma' 7.8 punti għal plaċebo.
English: Sycrest is a medicine that contains the active substance asenapine.
Maltese: Sycrest huwa mediċina li fiha s-sustanza attiva asenapina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sycrest on 1 September 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Sycrest valida fl-Unjoni Ewropea kollha fl-1 ta' Settembru 2010.
English: It is thought that Sycrest works by blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Maltese: Huwa maħsub li Sycrest jaħdem billi jimblokka riċetturi għannewrotrażmettituri 5-idrossitripamina (imsejħa wkoll serotonina) u dopamina.
English: Sycrest was also studied in patients with schizophrenia.
Maltese: Sycrest ġie studjat ukoll f'pazjenti bi skizofrenja.
English: In two of these studies, a total of 977 adult patients were given Sycrest, olanzapine (another antipsychotic medicine) or placebo (a dummy treatment) over three weeks.
Maltese: Fi tnejn minn dawn l-istudji, total ta' 977 pazjent adult ingħataw Sycrest, l-olanzapina (mediċina antipsikotika oħra) jew plaċebo (kura finta) għal tliet ġimgħat.
English: In the second long-term study, the reductions in Y-MRS score were 10.3 and 7.9 for Sycrest and placebo, respectively, after three weeks and 12.7 and 9.3 after 12 weeks.
Maltese: 3 u 7.9 għal Sycrest u plaċebo, rispettivament, wara tliet ġimgħat u 12.7 u 9.3 wara 12-il ġimgħa.
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Maltese: Hija magħrufa bħala antipsikotiku ‘atipiku' minħabba li hija differenti mill-mediċini antipsikotiċi aktar antiki li ilhom disponibbli sa millħamsinijiet.
English: What is Sycrest?
Maltese: X'inhu Sycrest?
English: Four main studies looked at the use of Sycrest for manic episodes in bipolar disorder.
Maltese: Erba' studji prinċipali studjaw l-użu ta' Sycrest għal episodji manijaċi f'disturb bipolari.
English: Sycrest is used to treat moderate to severe manic episodes (extremely high mood) in adults (aged 18 years or over) with bipolar disorder, a mental illness in which patients have periods of abnormally high mood alternating with periods of normal or depressed mood.
Maltese: Sycrest jintuża biex jikkura episodji manijaċi moderati għal severi (burdata tajba ħafna) fl-adulti (minn 18-il sena 'l fuq) b'disturb bipolari, mard mentali li fih, il-pazjenti jkollhom perjodi ta' burdata tajba b'mod anomalu li talterna ma' perjodi ta' burdata normali jew ta' dipressjoni.
English: The other two studies lasted longer: one compared Sycrest with olanzapine over nine weeks in patients who had come from the short-term studies; and the other was a 12-week ‘add on' study, in which 326 patients who were already being treated with another medicine (lithium or valproic acid) were also given either Sycrest or placebo.
Maltese: Iż-żewġ studji l-oħrajn damu iktar: wieħed qabbel Sycrest mal-olanzapina fuq disa' ġimgħat f'pazjenti li kienu ġew mill-istudji fuq perjodu ta' żmien qasir; u lieħor kien studju ‘addizzjonali' ta' 12-il ġimgħa, li fih 326 pazjent li kienu diġà ġew ikkurati b'mediċina oħra (litju jew aċidu valporiku) ingħataw ukoll Sycrest jew plaċebo.
English: The most common side effects with Sycrest (seen in more than 1 patient in 10) are anxiety and somnolence (sleepiness).
Maltese: L-effetti sekondarji l-aktar komuni b'Sycrest (osservati f'aktar minn pazjent 1 minn kull 10) huma ansjetà u somnolenza (ngħas).
English: How has Sycrest been studied?
Maltese: Kif ġie studjat Sycrest?
English: Why has Sycrest been approved?
Maltese: Għaliex ġie approvat Sycrest?
English: The studies included short- and long-term studies in patients receiving Sycrest, other medicines for schizophrenia (olanzapine, risperidone or haloperidol) or placebo.
Maltese: L-istudji inkludew studji fuq perjodu ta' żmien qasir u fuq perjodu ta' żmien twil f'pazjenti li rċevew Sycrest, mediċini oħrajn għall-iskizofrenija (l-olanzapina, ir-risperidona jew il-ħaloperidol) jew plaċebo.
English: Sycrest was effective at treating manic episodes in patients with bipolar disorder.
Maltese: Sycrest kien effikaċi fil-kura ta' episodji manijaċi f'pazjenti b'disturb bipolari.
English: For the full list of side effects and restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha, ara lfuljett ta' tagħrif.
English: The CHMP decided that Sycrest's benefits are greater than its risks and recommended that it be given marketing authorisation for the treatment of moderate to severe manic episodes in patients with bipolar disorder.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Sycrest huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq għall-kura ta' episodji manijaċi moderati għal severi f'pazjenti b'disturb bipolari.
English: What is the risk associated with Sycrest?
Maltese: Għal xiex jintuża Sycrest?
English: In the first long-term study, a reduction in Y-MRS score of 12.9 was seen in patients taking Sycrest compared with 16.2 in patients taking olanzapine.
Maltese: Fl-ewwel studju fuq perjodu ta' żmien twil, deher tnaqqis fil-punteġġ ta' Y-MRS ta' 12.9 f'pazjenti li kienu qegħdin jieħdu Sycrest meta mqabbel ma' 16.2 f'pazjenti li kienu qegħdin jieħdu l-olanzapina.
English: What benefit has Sycrest shown during the studies?
Maltese: Liema benefiċċju wera Sycrest waqt l-istudji?
English: A risk management plan has been developed to ensure that Sycrest is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Sycrest jintuża bl-aktar mod sigur possibbli.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Maltese: Dan ifixkel is-sinjali trażmessi bejn iċ-ċelloli talmoħħ permezz ta' ‘newrotrażmettituri', sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: phenobarbital or phenytoin).
Maltese: phenobarbital jew phenytoin).
English: The list of associated symptoms is provided in section 4, Possible side effects.
Maltese: Il-lista ta' sintomi assoċjati tinsab f'sezzjoni 4, Effetti Sekondarji Possibbli.
English: Secura Bio Limited
Maltese: FIS-SUQ Secura Bio Limited
English: quinidine, propafenone or sotalol.
Maltese: procainamide, quinidine, propafenone u sotalol.
English: Microcrystalline cellulose Pregelatinised starch (maize)
Maltese: Microcrystalline cellulose Pregelatinised starch (qamħirrum)
English: >1.0 x ULN and ≤1.5 x ULN
Maltese: >1.0 x ULN u ≤1.5 x ULN
English: Overall response [95% CI]
Maltese: Rispons ġenerali [95% CI]
English: In the event of QT prolongation during treatment:
Maltese: QT matul it-trattament:
English: Colitis, haematemesis, gastrointestinal pain
Maltese: Kolite, ematemeżi, uġigħ gastrointestinali
English: The median OS was 17.5 months.
Maltese: L-OS medjan kien ta' 17.5 xhur.
English: Treatment discontinuation due to infections was reported in 5% of patients.
Maltese: Kien irrappurtat li t-trattament twaqqaf minħabba infezzjonijiet f'5% tal-pazjenti.
English: Pneumonia fungal, hepatitis B, aspergillosis
Maltese: Pulmonite fungali, epatite B, asperġillożi
English: Packs containing 6, 12 or 24 capsules.
Maltese: Pakketti li fihom 6, 12 jew 24 kapsula.
English: Its fraction in the erythrocyte is 0.60 in vitro, independent of the concentration.
Maltese: Il-frazzjoni tiegħu fl-eritroċiti hi ta' 0.60 in vitro, indipendentament mill-konċentrazzjoni.
English: Panobinostat is a P-gp substrate.
Maltese: Panobinostat hu sottostrat ta' P-gp.
English: 95% CI [0.31; 0.72] Logrank p-value=0.0003
Maltese: Proporzjon ta' periklu = 0.47 95% CI [0.31; 0.72] Logrank valur p =0.
English: Metabolism via CYP2D6 and 2C19 was minor.
Maltese: Il-metaboliżmu permezz ta' CYP2D6 u 2C19 kien ftit li xejn.
English: The median PFS (95% CI) was 12.0 months (10.3, 12.9) and 8.1 months (7.6, 9.2), respectively.
Maltese: Il-PFS (95% CI) medju kien ta' 12.0 xhur (10.3, 12.9) u 8.1 xhur (7.6, 9.2), rispettivament.
English: SGOT = serum glutamic oxaloacetic transaminase; AST = aspartate aminotransferase
Maltese: SGOT = serum glutamic oxaloacetic transaminase;
English: Censoring Times PAN+BTZ+Dex (n/N=44/73) PBO+BTZ+Dex (n/N=54/74)
Maltese: Żminijiet ta‘ ċensura PAN+BTZ+Dex (n/N=44/73) PBO+BTZ+Dex (n/N=54/74)
English: Moderate >1.5 x ULN and ≤3.0 x ULN
Maltese: >1.5 x ULN u ≤3.0 x ULN
English: Omit dose
Maltese: Ieqaf għal dejjem
English: Adverse reactions leading to permanent discontinuation occurred in 30%, 44% and 47% of patients aged <65 years, 65-75 years and ≥75 years, respectively.
Maltese: Kien hemm reazzjonijiet avversi li wasslu għal twaqqif permanenti fi 30%, 44% u 47% tal-pazjenti li kellhom <65 sena, 65-75 sena u ≥75 sena, rispettivament.
English: Cytochrome P450 3A4 (CYP3A4) is the main oxidation enzyme, with potential minor involvement of CYP2D6 and 2C19.
Maltese: Iċ-ċitokromu P450 3A4 (CYP3A4) hu l-enzima ossidattiva ewlieni, bl-involviment potenzjali minutr ta' CYP2D6 u 2C19.
English: Patients achieved an ORR (≥PR (partial response)) of 34.5% and 52.7% (≥MR (minimal response)).
Maltese: Ilpazjenti kisbu ORR (≥PR (rispons parzjali)) ta' 34.5% u 52.7% (≥MR (rispons minimu)).
English: Grade 3 neutropenia (<1.0-0.5 x 109/l)
Maltese: Newtropenija fi grad 3 (<1.0-0.5 x 109/l)
English: itraconazole, voriconazole or posaconazole) and some bacterial infections (such as antibiotics like clarithromycin or telithromycin).
Maltese: itraconazole, voriconazole jew posaconazole) u xi infezzjonijiet batteriċi (bħal xi antibijotiċi bħal clarithromycin jew telithromycin).
English: Kaplan Meier medians PAN+BTZ+Dex: 12.48 months PBO+BTZ+Dex: 4.70 months
Maltese: Medji ta' Kaplan Meier PAN+BTZ+Dex: 12.48 xhur PBO+BTZ+Dex: 4.70 xhur
English: Grade 4 neutropenia (<0.5 x 109/l) or febrile neutropenia (<1.0 x 109/l and fever ≥38.5°C)
Maltese: Newtropenija fi grade 4 (<0.5 x 109/l) jew newtropenija febrili (<1.0 x 109/l u deni ≥38.5°C)
English: • increased blood levels of the liver enzymes alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP).
Maltese: • żieda fil-livell tal-alanina aminotransferasi (ALT) fl-enzimi tal-fwied, aspartate aminotransferase (AST) jew alkalina phosphatase (ALP) fid-demm.
English: An increase in early resorptions was observed in female rats (doses ≥30 mg/kg).
Maltese: Ġiet osservata żieda fir-resorbiment bikri fost il-firien nisa (dożi ≥30 mg/kg).
English: Panobinostat may increase the QTc interval (see section 4.4).
Maltese: Panobinostat jista' jżid l-intervall tal-QTc (ara sezzjoni 4.4).
English: PVC/PCTFE/Alu blister containing 6 capsules.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji PVC/PCTFE/Alu li fihom 6 kapsuli.
English: The parent substance is deemed to be responsible for the overall pharmacological activity of panobinostat.
Maltese: Is-sustanza parentali jidher li hi responsabbli għall-attività farmakoloġika sħiħa ta' panobinostat.
English: The volume of distribution of panobinostat at steady state (Vss) is approximately 1,000 litres based on final parameter estimates in the population pharmacokinetic analysis.
Maltese: Il-volum ta' distribuzzjoni ta' panobinostat fi stat wieqaf (steady state - Vss) hu ta' madwar 1,000 litru skont l-istimi tal-parametri finali fl-analiż farmakokinetika tal-popolazzjoni.
English: Discontinuation due to adverse events, regardless of causality, was observed in 36.2% of patients.
Maltese: Kien hemm twaqqif għal kollox minħabba episodji avversi, indipendentament mill-kawżalità, fi 36.2% tal-pazjenti.
English: The absolute oral bioavailability of panobinostat was approximately 21%.
Maltese: Il-bijodisponibbilità orali assoluta għal panobinostat kienet ta' madwar 21%.
English: Apparent panobinostat renal clearance (CLR/F) was found to range from 2.4 to 5.5 l/h.
Maltese: It-tneħħija apparenti ta' panobinostat mill-kliewi (CLR/F) instab li kienet bejn 2.4 u 5.5 l/h.
English: Grade 3-4 events more frequently observed in patients included the following (percentages presented for patients <65 years, 65-75 years and ≥75 years of age, respectively): thrombocytopenia (60%, 74%, and 91%), anaemia (16%, 17% and 29%), diarrhoea (21%, 27% and 47%), and fatigue (18%, 28% and 47%).
Maltese: Fil-pazjenti dehru episodji fi grad 3-4 u dawn kienu jinkludu (persentaġġi ppreżentati għal pazjenti li kellhom <65 sena, 65-75 sena u ≥75 sena, rispettivament): tromboċitopenija (60%, 74%, u 91%), anemija (16%, 17% u 29%), dijarea (21%, 27% u 47%), u għeja (18%, 28% u 47%).
English: QT syndrome.
Maltese: • b'sindromu ta' QT twil.
English: Of note, whereas grade 3 and grade 4 neutropenia were observed in 28% and 7% of patients, respectively, febrile neutropenia was observed in 1% of patients (see section 4.8).
Maltese: Ta' min wieħed jinnota li, filwaqt li nnewtropenija fi grad 3 u grad 4 kienet osservata fi 28% u 7% tal-pazjenti, rispettivament, innewtropenija febrili kienet osservata f'1% tal-pazjenti (ara sezzjoni 4.8).
English: Platelets 10 x 109/l
Maltese: <25 x 109/l
English: Cycles 9-16 (3-week cycles)
Maltese: Ċikli 9-16 (ċikli ta' 3 ġimgħat)
English: Bradycardia, atrial fibrillation, sinus tachycardia, tachycardia, palpitation
Maltese: Bradikardija, fibrillazzjoni atrijali, takikardija sinużali, takikardija, palpitazzjoni
English: Week 1 Week 2 Week 3 Day 1
Maltese: Ġimgħa 1 Ġimgħa 2 Ġimgħa 3 Jum 1
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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); and not known (cannot be estimated from available data).
Maltese: Barra minn hekk, il-kategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa tal-mediċina tissejjes fuq il-konvenzjoni li ġejja (CIOMS III): 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); u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: - St. John's wort, a herbal medicine used to treat depression.
Maltese: John's wort, mediċina erbali użata biex tittratta d-dipressjoni.
English: Panobinostat may prolong cardiac ventricular repolarisation (QT interval).
Maltese: Panobinostat jista' jtawwal ir-ripolarizzazzjoni ventrikulari kardijaka (intervall tal-QT).
English: Farydak is a histone deacetylase (HDAC) inhibitor that inhibits the enzymatic activity of HDACs at nanomolar concentrations.
Maltese: Farydak huwa inibitur ta' histone deacetylase (HDAC) li jinibixxi l-attività enzimatika tal-HDACs f'konċentrazzjonijiet nanomolari.
English: Capsule shell
Maltese: 12-il kapsula
English: Panobinostat is moderately (approximately 90%) bound to human plasma proteins.
Maltese: Panobinostat jeħel b'mod moderat (madwar 90%) mal-porteini tal-plażma umani.
English: Gastrointestinal toxicity
Maltese: Tossiċità gastronintestinali
English: CTC grade 3 fatigue was reported in 15.7% of the patients, and grade 4 in 1.3%.
Maltese: L-għeja skont CTC fi grad 3 kienet irrappurtata fi 15.7% tal-pazjenti, u fi grad 4 f'1.3%.
English: Cycles 1-8 (3-week cycles)
Maltese: Ċikli 1-8 (ċikli ta' 3 ġimgħat)
English: Septic shock, urinary tract infection, viral infection, oral herpes, Clostridium difficile colitis, otitis media, cellulitis, sepsis, gastroenteritis, lower respiratory tract infection, candidiasis
Maltese: Xokk settiku, infezzjoni fil-passaġġ tal-awrina, infezzjoni virali, erpite orali, kolite Clostridium difficile, otitis media, ċellulite, sepsis, gastroenterite, infezzjoni fin-naħa ta' isfel talpassaġġ respiratorju, kandidijażi
English: Pulmonary haemorrhage, haemoptysis
Maltese: Emorraġija pulmonari, emoptiżi
English: Blood urea increased, glomerular filtration rate decreased, blood alkaline phosphatase increased, electrocardiogram QT prolonged, blood creatinine increased a, SGPT alanine transaminase (ALT) increased a, SGOT aspartate transaminase (AST) increased a a Frequency is based on laboratory values
Maltese: Żieda tal-urea fid-demm, tnaqqis fir-rata ta' filtrazzjoni glomerulari, żieda tal-fosfat talalkalina fid-demm, titwil tal-QT flelettrokardjogramm, żieda tal-kreatinina fiddemm a, żieda tat-transaminasi tal-alanina SGPT (ALT)a, żieda tat-transaminasi tal-aspartat SGOT (AST)a a Il-frekwenza tissejjes fuq valuri tal-laboratorju
English: 28 August 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI 28 Awwissu 2015
English: The primary endpoint was progression free survival (PFS) as per modified European Bone Marrow Transplant Group (mEBMT) criteria and as assessed by the investigator.
Maltese: L-endpoint primarju kien ta' sopravvivenza ħielsa minn kwalunkwe progressjoni (progression free survival - PFS) skont il-kriterji mmodifikati tal-European Bone Marrow Transplant Group (mEBMT) u skont kif evalwat mill-investigatur.
English: When Farydak is co-administered with sensitive CYP2D6 substrates (e.g. atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine and pimozide), dose titrate individual CYP2D6 substrates based on tolerability and frequently monitor patients for adverse reactions.
Maltese: Meta Farydak jingħata flimkien ma' sottostrati sensittivi ta' CYP2D6 (eż. atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine u pimozide), agħmel titrazzjoni tad-doża għal sottostrati individwali ta' CYP2D6 abbażi tat-tolerabbiltà u mmonitorja l-pazjenti ta' spiss minħabba reazzjonijiet avversi.
English: Thrombocytopenia rarely leads to treatment discontinuation (1.6% of patients).
Maltese: It-tromboċitopenija rari twassal sabiex jitwaqqaf it-trattament (1.6% tal-pazjenti).
English: The median PFS (95% CI) was 12.5 months (7.26, 14.03) in the panobinostat + bortezomib + dexamethasone arm and 4.7 months (3.71, 6.05) in the placebo + bortezomib + and dexamethasone arm [HR: 0.47 (0.31, 0.72)].
Maltese: Il-PFS medju (95% CI) kien ta' 12.5 xhur (7.26, 14.03) fil-grupp mogħti ta' panobinostat + bortezomib + dexamethasone u 4.7 xhur (3.71, 6.05) fil-grupp mogħti plaċebo + bortezomib + dexamethasone [HR: 0.47 (0.31, 0.
English: Panobinostat dose on recovery to ≤ grade 1
Maltese: panobinostat meta l pazjent jirkupra għal ≤ grad 1
English: Fatigue and asthenia were reported in 41.2% and 22.0% of patients, respectively.
Maltese: L-għeja u l-astenja kienu rrappurtati f'41.2% u 22.0% tal-pazjenti, rispettivament.
English: You may need medical treatment.
Maltese: Jaf ikollok bżonn ta' trattament mediku.
English: The remainders are metabolites.
Maltese: Il-kumplament hu metaboliti.
English: The thyroid changes including hormones in dogs (decrease triodothyronine (T3)) and rats (decrease in triodothyronine (T3), tetraiodothyronine (T4) (males) and thyroid stimulating hormone (TSH)) were observed at exposures corresponding to 0.07-2.2 of the human AUC observed clinically.
Maltese: Il-bidliet fit-tirojde, inklużi ormonji fi klieb (tnaqqis ta' triodothyronine (T3)) u firien (tnaqqis ta' triodothyronine (T3), tetraiodothyronine (T4) (irġiel) u l-ormonju li jistimola t-tirojde (TSH)) kienu osservati f'espożizzjonijiet li jikkorrespondu għal 0.07-2.2 tal-AUC uman osservat klinikament.
English: ULN = upper limit of the normal range
Maltese: ULN = l-ogħla limitu tal-firxa normali (upper limit of the normal range) * Imsejjes fuq il-klassifikazzjoni NCI-CTEP
English: Iron oxide, black (E172) Propylene glycol (E1520) Shellac glaze
Maltese: Propylene glycol (E1520)
English: • CTC grade 3 or 4 toxicity recurrence - a further dose reduction may be considered once the adverse event has resolved to CTC grade <1.
Maltese: • Tossiċità rikorrenti ta' CTC fi grad 3 jew 4 - jista' jitqies aktar tnaqqis tad-doża jekk l-episodju ta' reazzjoni avversa jinżel għal CTC fi grad <1.
English: Mild
Maltese: Moderat
English: Dizziness may occur following administration of Farydak (see section 4.8).
Maltese: Jista' jkun hemm sturdament wara l-għoti ta' Farydak (ara sezzjoni 4.8).
English: Concomitant use of anti-arrhythmic medicinal products (including, but not limited to, amiodarone, disopyramide, procainamide, quinidine and sotalol) and other substances that are known to prolong the QT interval (including, but not limited to, chloroquine, halofantrine, clarithromycin, methadone, moxifloxacin, bepridil and pimozide) is not recommended.
Maltese: L-użu fl-istess ħin ta' prodotti mediċinali antiarritmiċi (inkluż, imma mhux biss, amiodarone, disopyramide, procainamide, quinidine u sotalol) u sustanzi oħrajn magħrufa li jtawlu lintervall tal-QT (inkluż, imma mhux biss, chloroquine, halofantrine, clarithromycin, methadone, moxifloxacin, bepridil u pimozide) mhuwiex irrakkomandat.
English: Pertinent metabolic pathways involved in the biotransformation of panobinostat are reduction, hydrolysis, oxidation and glucuronidation processes.
Maltese: Il-mogħdijiet metaboliċi pertinenti involuti fil-bijotrasformazzjoni ta' panobinostat huma proċessi ta' riduzzjoni (reduction), idroliżi, ossidazzjoni (oxidation) u glukuronidazzjoni (glucuronidation).