FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately 70% of patients in the mipomersen groups of pivotal trials had at least a 15% decrease in LDL-C levels from baseline to PET in comparison with approximately 20% of patients in the placebo groups.
Maltese: Madwar 70% tal-pazjenti fil-gruppi ta' mipomersen fil-provi pivotali kellhom millinqas tnaqqis ta' 15% fil-livelli tal-LDL-C mil-linja bażi għall-PET meta mqabbla ma' madwar 20% tal-pazjenti fil-gruppi tal-plaċebo.
English: This was not considered applicable either, even if possible within the scope of Article 2 of Commission Regulation (EC) No. 507/2006, as the requirements as defined in Article 4 of the said Regulation were not met, in particular the demonstration by the applicant of a positive risk-benefit balance of the medicinal product and the likelihood to provide comprehensive clinical data by way of specific obligations.
Maltese: Lanqas din ma tqieset applikabbli, anki jekk possibbli fl-ambitu tal-Artikolu 2 tar-Regolament talKummissjoni (KE) Nru 507/2006, peress li r-rekwiżiti definiti fl-Artikolu 4 tarRegolament imsemmi ma kinux sodisfatti, b'mod partikolari t-turija mill-applikant ta' bilanċ pożittiv bejn ir-riskji u l-benefiċċji tal-prodott mediċinali u l-probabbiltà li tiġi pprovduta dejta klinika komprensiva permezz ta' obbligi speċifiċi.
English: However, while it is agreed that the LDL reduction is predictive of a long-term CVS risk reduction, the implied magnitude of reduction of CHD risk of 50% is speculative.
Maltese: Madankollu, filwaqt li huwa aċċettat li t-tnaqqis fl-LDL jipprevedi tnaqqis fit-tul ta' riskju kardjovaskulari, id-daqs impliċitu ta' tnaqqis ta' 50% fir-riskju ta' CHD huwa spekulattiv.
English: In the pivotal study in HoFH patients (ISIS 301012-CS5), hepatic fat was not routinely measured postbaseline, however, according to the applicant, there were 11 patients from CS5 with liver fat content assessment at baseline and at 12 months or longer on mipomersen treatment.
Maltese: Fl-istudju pivotali fuq pazjenti b'HoFH (ISIS 301012-CS5), ixxaħam fil-fwied ma ġiex imkejjel regolarment wara l-linja bażi, madankollu, skont lapplikant, kien hemm 11-il pazjent minn CS5 li ġew evalwati għall-kontenut ta' xaħam fil-fwied fil-linja bażi u wara 12-il xahar jew aktar fuq kura b'mipomersen.
English: Following the CHMP scientific conclusions adopted on 13 December 2012 that Kynamro was not approvable for the treatment of
Maltese: Wara l-konklużjonijiet xjentifiċi tas-CHMP adottati fit-13 ta' Diċembru 2012 li Kynamro ma kienx approvabbli għall-kura ta'
English: Potential negative effects, in particular inflammatory effects, immunological and renal toxicity (as shown by proteinuria) on other cardiovascular risk factors may counteract the potential beneficial effect on CVS outcome due to reduction in LDL-C.
Maltese: Effetti negattivi potenzjali, b'mod partikolari, tossiċità immunoloġika u renali (kif jidher minn proteinurja) fuq fatturi oħra ta' riskju kardjovaskulari jistgħu jinnewtralizzaw l-effett ta' benefiċċju potenzjali fuq l-effett kardjovaskulari minħabba tnaqqis fl-LDL-C.
English: - a median increase in hepatic fat fraction of 9.6% in mipomersen treated patients versus 0.02% in placebo-treated patients was observed,
Maltese: - żieda medjana ta' 9.6% kienet osservata fl-ammont ta' xaħam fil-fwied f'pazjenti li rċevew kura b'mipomersen kontra 0.02% f'pazjenti li rċevew plaċebo,
English: The applicant presents a comprehensive approach to risk management for liver effects, including hepatic transaminase monitoring, liver imaging to assess hepatic fat, and observations of clinical signs/symptoms of possible liver damage.
Maltese: Lapplikant jippreżenta approċċ komprensiv għall-ġestjoni tar-riskju għall-effetti talfwied, inkluż monitoraġġ tat-transaminażi tal-fwied, immaġni tal-fwied biex jevalwa x-xaħam fil-fwied, u osservazzjonijiet ta' sinjali/sintomi kliniċi ta' ħsara possibbli filfwied.
English: For the individual patient, the worst case scenario could be that they might not obtain the potential benefit of mipomersen in terms of reduced CVS morbidity/mortality because they cannot tolerate long-term treatment, but might be harmed by progressive liver disease resulting from mipomersen-induced steatohepatitis.
Maltese: Għall-pazjent individwali, l-agħar sitwazzjoni possibbli tista' tkun li jistgħu ma jiksbux il-benefiċċju potenzjali ta' mipomersen f'termini ta' tnaqqis fil-morbidità/mortalità kardjovaskulari minħabba li ma jistgħux jittolleraw kura fit-tul, imma jistgħu jiġu pperikolati minn mard progressiv tal-fwied li ġej minn steatohepatitis indott minn mipomersen.
English: Mipomersen treatment can cause liver enzyme elevations and hepatic steatosis and this may induce steatohepatitis.
Maltese: Il-kura b'Mipomersen tista' tikkawża żieda fl-enzimi tal-fwied u stejatożi epatika u dan jista' jikkaġuna steatohepatitis.
English: Within (maximal) 2 years of treatment almost 50% (18/38) of these HoFH patients withdrew from treatment due to AEs, mainly due to injection site reactions (ISRs), flu-like symptoms (FLS) and liver enzyme elevations.
Maltese: Fi żmien (massimu) sentejn ta' kura, kważi 50% (18/38) ta' dawn il-pazjenti b'HoFH irtiraw mill-kura minħabba avvenimenti avversi, prinċipalment minħabba reazzjonijiet fis-sit tal-injezzjoni (ISRs), sintomi bħal tal-influwenza (FLS) u żieda fl-enzimi tal-fwied.
English: Potential negative effects on cardiovascular risk factors may counteract the potential beneficial effect on CV outcome due to reduction in LDL-C.
Maltese: L-effetti negattivi potenzjali fuq fatturi ta' riskju kardjovaskulari jistgħu jinnewtralizzaw l-effett ta' benefiċċju potenzjali fuq l-effett kardjovaskulari minħabba t-tnaqqis fl-LDL-C.
English: Twenty two (15.6%) patients experienced increases in ALT and AST that met protocol-defined monitoring/safety rules for liver chemistry; for 8 (5.7%) of these patients, dosing with mipomersen was stopped.
Maltese: 6%) pazjent esperjenzaw żidiet fl-ALT u fl-AST li laħqu regoli definiti millprotokoll għal monitoraġġ/sigurtà għall-kimika tal-fwied; għal 8 (5.7%) minn dawk ilpazjenti, l-għoti ta' dożi ta' mipomersen twaqqaf.
English: Furthermore, in the placebo arm of the pooled phase 2 and 3 trial population including patients at somewhat lower CVS risk (as compared with the very high CV risk in HoFH patients), a higher number of MACE was noted, again potentially indicating that the absence of MACE in the placebo arms of the pivotal studies of overall small size might be a chance finding.
Maltese: Barra minn hekk, fil-fergħa tal-plaċebo tal-popolazzjoni pooled talprova tal-fażi 2 u 3 li fiha ħadu sehem pazjenti b'riskju kardjovaskulari kemxejn aktar baxx (meta mqabbel mar-riskju kardjovaskulari għoli ħafna f'pazjenti b'HoFH), kien innotat għadd kbir ta' MACE, li għal darb'oħra potenzjalment jindika li n-nuqqas ta' MACE fil-fergħat tal-plaċebo tal-istudji pivotali li ġeneralment kienu ta' daqs żgħir jista' jkun riżultat b'kumbinazzjoni.
English: The indication originally proposed in the mipomersen MAA included both HoFH and severe HeFH.
Maltese: L-indikazzjoni oriġinarjament proposta fl-MAA ta' mipomersen kienet tinkludi kemm HoFH kif ukoll HeFH severa.
English: The adopted Guideline on Clinical Investigation of Medicinal Products in the Treatment of Lipid Disorders (CPMP/EWP/3020/03/2004), states on the matter that the safety database should be large enough to reasonably rule out any suspicion of a detrimental effect of the new drug on mortality and that this requirement acquires special relevance in case of drugs belonging to a new therapeutic class.
Maltese: Il-Linja Gwida adottata dwar Prodotti Mediċina fil-Kura ta' Disturbi fil-Lipidi (CPMP/EWP/3020/03/2004), tiddikjara fuq il-kwistjoni li d-database dwar is-sigurtà għandha tkun kbira biżżejjed biex b'mod raġonevoli teskludi kwalunkwe suspett ta' effett detrimentali tal-mediċina l-ġdida fuq il-mortalità u li dan ir-rekwiżit jikseb rilevanza speċjali fil-każ ta' mediċini li jagħmlu parti minn klassi terapewtika ġdida.
English: The applicant requested a re-examination of the CHMP's opinion for mipomersen, to re-assess the benefit/risk in the very rare Homozygous Familial Hypercholesterolaemia (HoFH) population (estimated size in the European Union, 500 patients) with a high unmet medical need.
Maltese: L-applikant talab eżaminazzjoni mill-ġdid tal-opinjoni tas-CHMP għal mipomersen, biex jerġa' jiġi evalwat il-benefiċċju/riskju fil-popolazzjoni rari ħafna talIperkolesterolemija Omozigota Familjali (HoFH) (daqs stmat fl-Unjoni Ewropea, 500 pazjent) bi ħtieġa medika għolja mhux sodisfatta.
English: The applicant addressed the CHMP's concerns of liver and cardiovascular safety, tolerability and patient retention, as well as post-approval management plans, in light of the benefit/risk in the HoFH population, which the applicant believes is positive.
Maltese: L-applikant indirizza t-tħassib tas-CHMP dwar is-sigurtà epatika u kardjovaskulari, it-tollerabilità u ż-żamma ta' pazjenti, kif ukoll il-pjanijiet ta' ġestjoni wara l-approvazzjoni, fid-dawl talbenefiċċju/riskju fil-popolazzjoni ta' HoFH, li l-applikant jemmen huwa pożittiv.
English: Focusing on the targeted HoFH population, the CHMP noted that the withdrawal rate for HoFH patients who had been enrolled in the pivotal 6 months DB study CS5 and consented to further participate in the OL extension study CS6 (for one or two years, including the time in CS5), was approximately 60% (23/38) within the first two years.
Maltese: Waqt li ffoka fuq il-popolazzjoni fil-mira b'HoFH, is-CHMP innota li r-rata ta' rtirar għal pazjenti b'HoFH li kienu ħadu sehem fl-istudju pivotali DB CS5 fuq 6 xhur u kienu taw il-kunsens tagħhom biex anke jipparteċipaw fl-istudju ta' estensjoni OL CS6 (għal sena jew sentejn, inkluż iż-żmien f'CS5), kienet ta' madwar 60% (23/38) fl-ewwel sentejn.
English: In the pooled phase 3 studies, thirty six (13.8%) mipomersen-treated patients experienced increases in ALT and AST that met protocol-defined monitoring/safety rules for liver chemistry.
Maltese: Fl-istudji miġbura tal-fażi 3, 36 (13.8%) pazjent li rċevew kura b'mipomersen esperjenzaw żidiet fl-ALT u fl-AST li laħqu regoli definiti mill-protokoll għall-monitoraġġ/sigurtà għall-kimika tal-fwied.
English: For a medicinal product that is intended to protect patients at high CV risk, the data on Major Adverse Cardiac Event (MACE) during the phase 3 studies raise a safety concern.
Maltese: Għal prodott mediċinali li huwa maħsub li jipproteġi pazjenti f'riskju kardjovaskulari għoli, id-dejta dwar Avvenimenti Kardijaċi Avversi Maġġuri (MACE) matul l-istudji tal-fażi 3 tqajjem tħassib dwar issigurtà.
English: With respect to the Kynamro Patient Support programme, the CHMP considered that its usefulness, suitability and applicability in different EU countries are difficult to foresee.
Maltese: Fir-rigward tal-programm ta' Appoġġ għall-Pazjent ta' Kynamro, is-CHMP ikkunsidra li huwa diffiċli li wieħed jipprevedi l-utilità, l-adegwatezza u l-applikabilità tiegħu filpajjiżi differenti tal-UE.
English: • Within the context of the small number of patients tested, the 6-month treatment time of placebo-controlled studies, and the 6-month follow-up time, final conclusions regarding CVS adverse effects as demonstrated in the clinical studies cannot be reached at this time; however, the results of analyses performed to date do not provide support for a difference in the rate of MACE between treatment groups.
Maltese: • Fil-kuntest tal-għadd żgħir ta' pazjenti ttestjati, iż-żmien ta' kura ta' 6 xhur talistudji kkontrollati bi plaċebo, u ż-żmien ta' segwitu ta' 6 xhur, il-konklużjonijiet finali dwar l-effetti kardjovaskulari avversi kif dehru fl-istudji kliniċi ma jistgħux jintlaħqu issa, madankollu, ir-riżultati tal-analiżi mwettqa sal-lum ma jipprovdux appoġġ għal differenza fir-rata ta' MACE bejn il-gruppi ta' kura.
English: Concern remains about the potential progression of fatty liver disease to steatohepatitis and fibrosis, for which monitoring of patients at risk of developing inflammatory and fibrotic changes includes repeated liver biopsy.
Maltese: Għad baqa' tħassib dwar il-progressjoni potenzjali ta' mard b'xaħam fil-fwied għal steatohepatitis u fibrożi, li għalihom monitoraġġ ta' pazjenti f'riskju li jiżviluppaw tibdil infjammatorju u fibrotiku jinkludi bijopsiji ripetuti tal-fwied.
English: To conclude on ground 2, the discussion provided by the applicant for the reexamination of Kynamro does not provide a new insight to the former CHMP assessment on mipomersen treatment and CVS risk.
Maltese: Biex jikkonkludi dwar raġuni 2, id-diskussjoni pprovduta mill-applikant għalleżaminazzjoni mill-ġdid ta' Kynamro ma tipprovdi l-ebda għarfien ġdid lillevalwazzjoni preċedenti tas-CHMP dwar kura b'mipomersen u r-riskju kardjovaskulari.
English: The long-term benefit/risk of mipomersen remains undetermined, even if the indication is restricted to patients with HoFH.
Maltese: Il-benefiċċju/riskju ta' mipomersen fit-tul jibqa' mhux determinat, anki jekk lindikazzjoni hija limitata għal pazjenti b'HoFH.
English: Furthermore, the CHMP considered the input from the expert group meeting and noted that there was an agreement amongst the experts that the tolerability of mipomersen treatment was poor.
Maltese: Din ilfehma kienet ukoll appoġġjata mill-esperti li kkunsidraw l-estrapolazzjoni bħala ipotetika biss.
English: The CHMP concluded that such type of Marketing Authorisation could not be recommended in the present case as it does not fulfil the requirements of Article 14(8) of Regulation (EC) No 726/2004, in particular, as the applicant would be able to provide comprehensive data on the efficacy and safety under normal condition of use of Kynamro.
Maltese: Is-CHMP ikkonkluda li din it-tip ta' Awtorizzazzjoni għat-Tqegħid fis-Suq ma tistax tiġi rakkomandata fil-każ preżenti peress li ma tissodisfax ir-rekwiżiti talArtikolu 14(8) tar-Regolament (KE) Nru 726/2004, b'mod partikolari, peress li lapplikant jkun jista' jipprovdi dejta komprensiva dwar l-effikaċja u s-sigurtà taħt kundizzjonijiet normali ta' użu ta' Kynamro.
English: Overall summary of the scientific evaluation of Kynamro
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Kynamro
English: Statistically significant percent reductions with mipomersen compared to placebo were also observed for apo B, TC, and non HDL-C from baseline to PET.
Maltese: B'mod partikolari, l-iżbilanċ numeriku fl-avvenimenti kardjovaskulari globali, MACE u dħul l-isptar minħabba avvenimenti kardjovaskulari huma ta' tħassib.
English: There is no proven relationship between mipomersen treatment and the occurrence of neoplasm, mainly due to the low incidence rate, lack of systematic evaluation during the studies, and the short timing after start of mipomersen, but uncertainties about the clinical relevance of these findings remain.
Maltese: Ma hemm l-ebda relazzjoni ppruvata bejn kura b'mipomersen u lokkorrenza ta' neoplażmi, prinċipalment minħabba r-rata baxxa ta' inċidenza, innuqqas ta' evalwazzjoni sistematika matul l-istudji, u ż-żmien qasir wara l-bidu ta' mipomersen, iżda inċertezzi dwar ir-rilevanza klinika ta' dawn is-sejbiet jibqgħu.
English: The numerically higher number of neoplasms and cancer raises an additional safety concern.
Maltese: L-għadd numerikament ogħla ta' neoplażmi u ta' kanċer iqajjem tħassib addizzjonali għas-sigurtà.
English: The withdrawal rate - even if “similar to that observed with statins and other lipidlowering therapies and with other approved SC injectable therapies studied in similar long-term studies” as claimed by the applicant - must be seen in the context of the identified safety concerns and the limited population studied.
Maltese: SC injettabbli approvati oħra studjati fi studji simili fit-tul" kif iddikjarat mill-applikant - għandha titqies fil-kuntest tat-tħassib identifikat għassigurtà u l-popolazzjoni limitata studjata.
English: • The rates of discontinuation from mipomersen treatment (taking into account the patient's consented length of treatment) are similar to those observed with statins and other lipid-lowering therapies and with other approved SC injectable therapies studied in similar long-term studies, although, due to a lack of placebo control in the long-term extension study, the true adherence rate in this study is not possible to assess.
Maltese: • Ir-rati ta' twaqqif mill-kura b'mipomersen (b'kunsiderazzjoni tat-tul ta' kura mogħti b'kunsens mill-pazjent) huma simili għal dawk osservati bi statins u b'terapiji oħra li jbaxxu l-lipidi u b'terapiji
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom delay the dose in patients who experience severe side effects.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom doża f'pazjenti li jesperjenzaw effetti sekondarji severi.
English: Other information about Farydak
Maltese: Informazzjoni oħra dwar Farydak
English: Farydak contains the active substance panobinostat.
Maltese: Farydak fih is-sustanza attiva panobinostat.
English: The recommended starting dose of Farydak is 20 mg, taken on days 1, 3, 5, 8, 10 and 12 of the cycle.
Maltese: Id-doża inizjali rakkomandata ta' Farydak hija ta' 20 mg, li għandha tittieħed fil-jum 1, 3, 5, 8, 10 u 12 taċ-ċiklu.
English: The full EPAR and risk management plan summary for Farydak can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Farydak, panobinostat, is a type of medicine called a histone deacetylase (HDAC) inhibitor.
Maltese: Is-sustanza attiva f'Farydak, panobinostat, hija tip ta' mediċina msejħa inibitur ta' histone deacetylase (HDAC).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Farydak can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Farydak.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Farydak.
English: The benefits of Farydak have been shown in one main study involving 768 patients with multiple myeloma that had come back after previous treatments.
Maltese: Il-benefiċċji ta' Farydak intwerew fi studju ewlieni wieħed li involva 768 pazjent b'majeloma multipla li reġgħet tfaċċat wara kuri preċedenti.
English: Patients are given the medicine for 8 cycles, and further 8 cycles of treatment are recommended in those that benefit.
Maltese: Il-pazjenti jingħataw il-mediċina għal 8 ċikli, u 8 ċikli oħrajn ta' kura huma rakkomandati f'dawk li jibbenefikaw.
English: Why is Farydak approved?
Maltese: Għaliex ġie approvat Farydak?
English: Farydak is available as capsules (10, 15 and 20 mg) and it is given in 21-day treatment cycles, together with bortezomib and dexamethasone.
Maltese: Farydak jiġi bħala kapsuli (10, 15 u 20 mg) u jingħata f'ċikli ta' kura ta' 21 jum, flimkien ma' borteżomib u deżametason.
English: What are the risks associated with Farydak?
Maltese: X'inhuma r-riskji assoċjati ma' Farydak?
English: Farydak is a cancer medicine used in combination with two other medicines, bortezomib and dexamethasone, to treat multiple myeloma (a cancer of the bone marrow).
Maltese: Farydak huwa mediċina kontra l-kanċer użata flimkien ma' żewġ mediċini oħrajn, borteżomib u deżametason, biex tikkura majeloma multipla (kanċer tal-mudullun).
English: Because the number of patients with multiple myeloma is low, the disease is considered ‘rare', and Farydak was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 November 2012.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn majeloma multipla huwa baxx, il-marda hija kkunsidrata 'rari', u Farydak ġie kklassifikat bħala 'mediċina orfni' (mediċina li tintuża f'mard rari) fit8 ta' Novembru 2012.
English: When results were analysed just for the group of patients who had previously received at least two previous treatments, including bortezomib and an immunomodulatory medicine (thalidomide, lenalidomide or pomalidomide), the average time until the myeloma got worse was 12.5 months with Farydak, versus 4.7 months with placebo.
Maltese: Meta r-riżultati kienu analizzati biss għall-grupp ta' pazjenti li kienu rċevew qabel tal-anqas żewġ kuri preċedenti, inkluż borteżomib u mediċina immunomodulatorja (thalidomide, lenalidomide jew pomalidomide), iż-żmien medju sakemm il-majeloma marret għall-agħar kien ta' 12.5 xhur b'Farydak, meta mqabbel ma' 4.7 xhur bi plaċebo.
English: Effects on the heart occurred in between 1 and 2 patients in 10 and included tachycardia (increased heart rate), palpitations, and irregular heart rhythms (atrial fibrillation, sinus tachycardia); more rarely patients had changes in electrical conduction in the heart (prolonged QTc interval).
Maltese: Effetti fuq il-qalb seħħew f'bejn pazjent wieħed u żewġ pazjenti minn kull għaxra u inkludew takikardja (żieda fir-rata ta' taħbit tal-qalb), palpitazzjonijiet, u ritmi irregolari tal-qalb (fibrillazzjoni atrijali, takikardija tas-sinus); b'mod aktar rari l-pazjenti kellhom bidliet fil-konduzzjoni elettriku fil-qalb (intervall QTc imtawwal).
English: It blocks the activity of enzymes called histone deacetylases (HDACs), which are involved in switching the activity of genes on and off within cells.
Maltese: Timblokka l-attività ta' enzimi msejħin histone deacetylases (HDACs), li huma involuti flattivazzjoni/diżattivazzjoni tal-ġeni fiċ-ċelloli.
English: The most common side effects with Farydak (which may affect more than 1 in 10 people) are diarrhoea, tiredness, nausea (feeling sick) and vomiting, and effects on the blood such as thrombocytopenia (low levels of blood platelets which are important for blood clotting), anaemia and neutropenia and lymphopenia (low levels of certain white blood cells).
Maltese: L-effetti sekondarji l-aktar komuni b'Farydak (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma dijarea, għeja, nawżja (tħossok ma tiflaħx) u rimettar, u effetti fuq id-demm bħal tromboċitopenija (livelli baxxi ta' pjastrini tad-demm li huma importanti għall-għaqid tad-demm), anemija u newtropenija u limfopenija (livelli baxxi ta' ċerti ċelloli bojod tad-demm).
English: A risk management plan has been developed to ensure that Farydak is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Farydak jintuża bl-aktar mod sigur possibbli.
English: It is given to adults whose disease has come back or got worse after at least two previous treatments, including bortezomib and an immunomodulatory medicine (a medicine that acts on the immune system).
Maltese: Tingħata lill-adulti li l-marda tagħhom tkun reġgħet feġġet jew marret għall-agħar wara tal-anqas żewġ kuri preċedenti, inkluż borteżomib u mediċina immunomodulatorja (mediċina li taħdem fuq is-sistema immuni).
English: For the full list of all side effects reported with Farydak, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Farydak, ara l-fuljett ta' tagħrif.
English: In multiple myeloma, panobinostat is expected to keep genes that suppress the division and growth of the cancer cells switched ‘on'.
Maltese: F'majeloma multipla, panobinostat huwa mistenni li jżomm attivati l-ġeni li jrażżnu d-diviżjoni u t-tkabbir taċ-ċelloli tal-kanċer.
English: In addition, panobinostat works in a different way to existing treatments.
Maltese: Barra minn hekk, panobinostat jaħdem b'mod differenti minn kuri eżistenti.
English: Although the side effects were of concern and could not be justified in patients who could be given less toxic treatments, the CHMP considered that they were acceptable in this previously treated subgroup in view of the lack of alternatives, and could be managed.
Maltese: Għalkemm l-effetti sekondarji kienu ta' tħassib u ma setgħux jiġu ġġustifikati f'pazjenti li setgħu jingħataw anqas kuri tossikoloġiċi, is-CHMP ikkunsidra li kienu aċċettabbli f'dan is-sottogrupp li kien ikkurat qabel fid-dawl tan-nuqqas ta'
English: Further information can be found in the summary of the risk management plan.
Maltese: Aktar informazzjoni tista' tinstab fis-sommarju tal-pjan ta' ġestjoni tar-riskju.