FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily).
Maltese: - Bis-segment mhux ST elevat (anġina instabbli jew infart mijokardijaku mhux-mewġaQ): il-kura bi clopidogrel għandha tinbeda b'doża waħda qawwija tal-bidu ta' 300 mg u titkompla b'75 mg darba kuljum (b'acetylsalicylic acid (ASA) 75 mg-325 mg kuljum).
English: Marketing Authorisation Holder TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Il-Ġermanja l-Manifattur
English: Clonmel Healthcare Ltd. Tel: + 353 52 6177778
Maltese: Tel: + 353 52 6177778
English: Tel: + 34 911 61 03 81
Maltese: KRKA Farmacéutica, S.L. Tel: + 34 911 61 03 81
English: - You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Maltese: - Għandek tgħarraf lit-tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika (magħrufa wkoll bħala Purpura Trombotika Tromboċitopenika jew TTP) li tinkludi deni u tbenġil taħt il-ġilda li jidher bħala dbabar żgħar ħomor, b'għeja sfinita spjegabbli jew mhix spjegabbli, konfużjoni, sfurija tal-ġilda jew l-għajnejn (suffejra) (ara sezzjoni 4 t-taqsima dwar ‘Effetti sekondarji possibbli').
English: How to store Clopidogrel TAD
Maltese: Jekk tinsa tieħu Clopidogrel TAD
English: Proton Pump Inhibitors (PPI):
Maltese: Acetylsalicylic acid (ASA):
English: Haematuria
Maltese: Tqala
English: Diacerein and its active metabolite, rhein, are anthranquinone derivates.
Maltese: Diacerein u l-metabolit attiv tiegħu, rhein, huma derivati ta' anthranquinone.
English: Diacerein is a symptomatic slow acting drug in osteoarthritis (SYSADOA).
Maltese: Diacerein huwa mediċina sintomatika li taġixxi bil-mod fl-osteoartrite (SYSADOA).
English: The agreed new data lock point (DLP) of 31 December 2014 for all diacerein-containing medicinal products will be reflected in the list of Union reference dates (EURD list).
Maltese: Id-data lock point (DLP) ġdida miftiehma tal-31 ta' Diċembru 2014 għall-prodotti mediċinali kollha li fihom diacerein se tiġi riflessa fil-lista ta' dati ta' referenza tal-Unjoni (lista EURD).
English: It is thought that diacerein works by blocking/reducing the actions of interleukin-1β, a protein involved in the process of articular cartilage destruction and synovial inflammation (Yaron M et al., 1999; Alvarez Soria et al., 2008; Legendre F et al., 2009).
Maltese: Huwa maħsub li diacerein jaħdem billi jimblokka/jnaqqas l-azzjonijiet ta' interleukin1β, proteina nvoluta fil-proċess tal-qerda tal-qarquċa artikulari u infjammazzjoni sinovjali (Yaron M et al., 1999; Alvarez Soria et al., 2008;
English: Safety issues
Maltese: Kwistjonijiet ta' sigurtà
English: The main studies evaluating structural progression or disease modifying properties in OA ((i) Echodiah study (Dougados et al. 2001) with 255 patients in the diacerein arm and 252 under placebo for three years of treatment; and (ii) Pham study (2004) which included 85 patients in the diacerein arm and 85 under placebo during one year) did not show convincing evidence of efficacy of diacerein on pain or physical functioning.
Maltese: L-istudji ewlenin li vvalutaw il-progressjoni strutturali jew il-karatteristiċi li jimmodifikaw il-marda f'OA ((i) Echodiah study (Dougados et al. 2001) b'255 pazjent fil-grupp ta' diacerein u 252 taħt plaċebo għal tliet snin ta' kura; u (ii) studju Pham (2004) li kien jinkludi 85 pazjent fil-grupp ta' diacerein u 85 taħt plaċebo matul sena waħda) ma wrewx evidenza konvinċenti tal-effikaċja ta' diacerein fuq l-uġigħ jew il-funzjonament fiżiku.
English: In general, treatment includes non-pharmacological therapies such as weight control, physical therapy, exercise, patient education as well as pharmacological intervention.
Maltese: B'mod ġenerali, il-kura tinkludi terapiji mhux farmakoloġiċi bħallkontroll tal-piż, terapija fiżika, eżerċizzju, edukazzjoni tal-pazjent kif ukoll intervent farmakoloġiku.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for diacerein containing medicinal products;
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE bħala riżultat taddejta ta' farmakoviġilanza, għall-prodotti mediċinali li fihom diacerein;
English: In addition, in a comparative study of the efficacy and tolerability of two therapeutic regimens of diacerein (usual treatment (50 mg twice a day) for 3 months versus progressive treatment (50 mg once a day for one month; then 50 mg twice a day for two months) the proportion of patients developing diarrhoea decreased by approx. 10% in the group treated by 50mg once a day followed by 50mg twice a day compared to the group with no titration.
Maltese: Barra minn hekk, fi studju komparattiv tal-effikaċja u t-tollerabbiltà ta' żewġ programmi terapewtiċi ta' diacerein (kura normali (50 mg darbtejn kuljum) għal 3 xhur kontra kura progressiva (50 mg darba kuljum għal xahar; imbagħad 50 mg darbtejn kuljum għal xahrejn) il-proporzjon ta' pazjenti li żviluppaw dijarea naqas b'madwar 10% fil-grupp ikkurat b'50mg darba kuljum segwiti minn 50mg darbtejn kuljum meta mqabbel mal-grupp b'ebda titrazzjoni.
English: The present review showed that rash, pruritus and eczema were the most common cutaneous reactions reported in clinical trials but available post-marketing data revealed cases of erythema multiforme, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Maltese: Ir-reviżjoni attwali wriet li raxx, ħakk u ekżema kienu r-reazzjonijiet talġilda l-aktar komuni rrapportati fil-provi kliniċi iżda dejta disponibbli wara t-tqegħid fis-suq uriet każijiet ta' multiformi eritema, is-sindromu ta' Stevens-Johnson (SJS) u nekroliżi epidermali tossika (TEN).
English: Following the adoption of the PRAC recommendation during the November 2013 PRAC meeting, two MAHs expressed their disagreement with the initial recommendation for suspension.
Maltese: Wara l-adozzjoni tar-rakkomandazzjoni tal-PRAC matul il-laqgħa tal-PRAC ta' Novembru 2013, żewġ MAHs esprimew in-nuqqas ta' qbil tagħhom mar-rakkomandazzjoni inizjali għas-sospensjoni.
English: Hepatic reactions were reported, including symptomatic acute liver injury and one fatal case of fulminant hepatitis.
Maltese: Ġew irrapportati reazzjonijiet epatiċi, inkluża ħsara sintomatika akuta fil-fwied u każ wieħed fatali ta' epatite fulminanti.
English: The CMDh, having considered the revised final PRAC recommendation dated 10 July 2014 with regards to diacerein containing medicinal products, agrees with the recommendation therein as stated below:
Maltese: Is-CMDh, wara li kkunsidra r-rakkomandazzjoni finali riveduta tal-PRAC datata l-10 ta' Lulju 2014 firrigward ta' prodotti mediċinali li fihom diacerein, jaqbel mar-rakkomandazzjoni fiha kif iddikjarat hawn taħt:
English: In spontaneous reports, one quarter of serious gastrointestinal cases were related with diarrhoea.
Maltese: F'rapporti spontanji, kwart tal-każijiet gastrointestinali serji kienu relatati mad-dijarea.
English: In 2012, the French national competent authority (Agence nationale de sécurité du médicament et des produits de santé, ANSM) initiated a review of the benefit-risk of diacerein containing medicinal products that underlined the occurrence of very frequent digestive disorders, cases of hepatitis and serious skin reactions in patients treated with diacerein.
Maltese: Fl-2012, l-awtorità kompetenti nazzjonali Franċiża (Agence nationale de sécurité du médicament et des produits de santé, ANSM) bdiet reviżjoni tal-benefiċċju-riskju ta' prodotti mediċinali li fihom diacerein li enfasizzat l-okkorrenza ta' disturbi diġestivi frekwenti ħafna, każijiet ta' epatite u reazzjonijiet serji talġilda f'pazjenti li ngħataw kura b'diacerein.
English: With regards to the potential risk of hepatic reactions, several hepatic events have been reported, including serious hepatic reactions and one fatal case of hepatitis was reported.
Maltese: Fir-rigward tar-riskju potenzjali ta' reazzjonijiet epatiċi, kienu rrapportati diversi avvenimenti epatiċi, inklużi reazzjonijiet epatiċi serji u kien irrapportat każ fatali wieħed ta' epatite.
English: The PRAC recommended not to use diacerein-containing medicinal product for patients older than 65 years, but did not consider it as a contraindication.
Maltese: Il-PRAC irrakkomanda li prodotti mediċinali li fihom diacerein ma jintużawx għal pazjenti ta' aktar minn 65 sena, iżda ma qiesx dan bħala kontraindikazzjoni.
English: • The PRAC considered that available data from pre-clinical studies, clinical trials, post-marketing spontaneous case reports, and published literature have shown that the use of diacereincontaining products is associated with safety concerns such as frequent cases of severe diarrhoea and cases of potentially serious hepatotoxicity; a risk of cutaneous reactions could not be excluded.
Maltese: • Il-PRAC ikkunsidra li d-dejta disponibbli minn studji pre-kliniċi, provi kliniċi, rapporti ta' każijiet spontanji wara t-tqegħid fis-suq, u letteratura ppubblikata wrew li l-użu ta' prodotti li fihom diacerein huwa marbut ma' tħassib dwar is-sigurtà bħal każijiet frekwenti ta' dijarea severa u każijiet ta' epatotossiċità potenzjalment serja; ma setax jiġi eskluż r-riskju ta' reazzjonijiet talġilda.
English: The evidence obtained from different meta-analysis of the clinical trials performed with diacerein showed a small beneficial effect of diacerein in the treatment of OA of the knee and hip with different criteria for the inclusion of the clinical trials in the meta-analyses.
Maltese: L-evidenza li nkisbet minn meta-analiżi differenti tal-provi kliniċi li saru b'diacerein uriet effett benefiċċjali żgħir ta' diacerein fil-kura ta' OA tal-irkoppa u tal-ġenbejn bi kriterji differenti għallinklużjoni tal-provi kliniċi fil-meta-analiżi.
English: The PRAC also noted that spontaneous notifications reported serious cases of diarrhoea with dehydration and electrolyte disorders.
Maltese: Il-PRAC innota wkoll li n-notifiki spontanji rrapportaw każijiet serji ta' dijarea b'deidrazzjoni u disturbi fl-elettroliti.
English: The MAHs considered that there is adequate data supporting the efficacy of diacerein in the symptomatic treatment of osteoarthritis of the hip and the knee and proposed further risk minimisation measures to reduce the risk of diarrhoea and potential risk of hepatic reactions associated with diacerein.
Maltese: L-MAHs qiesu li hemm dejta adegwata li tappoġġja l-effikaċja ta' diacerein fil-kura sintomatika ta' osteoartrite tal-ġenbejn u tal-irkoppa u pproponew aktar miżuri għall-minimizzazzjoni tar-riskji biex jitnaqqas irriskju ta' dijarea u r-riskju potenzjali ta' reazzjonijiet epatiċi marbuta ma' diacerein.
English: Diacerein, as other anthraquinone derivatives, has a hepatotoxic effect for which the mechanism of action is unknown.
Maltese: Diacerein, bħal derivati oħra ta' anthraquinone, għandu effett epatotossiku li l-mekkaniżmu ta' azzjoni tiegħu mhuwiex magħruf.
English: • The PRAC concluded that the risk of severe diarrhoea associated with the use of diacerein containing medicinal products and the occurrence of potentially severe hepatic reactions could be mitigated by the above mentioned risk minimisation measures to be reflected in the SmPC and adequately monitored with yearly PSUR submissions.
Maltese: • Il-PRAC ikkonkluda li r-riskju ta' dijarea severa marbut mal-użu ta' prodotti mediċinali li fihom diacerein u l-okkorrenza ta' reazzjonijiet epatiċi potenzjalment severi jistgħu jiġu mitigati bilmiżuri għall-minimizzazzjoni tar-riskji msemmija hawn fuq għandhom jiġu riflessi fl-SmPC u jiġu adegwatament immonitorjati permezz ta' preżentazzjonijiet tal-PSUR kull sena.
English: The PRAC reviewed all available data from clinical studies, published literature, and post-marketing experience on the safety of the diacerein containing products, in particular in relation to the risk of hepatotoxicity, gastro-intestinal disorders and cutaneous disorders.
Maltese: Il-PRAC irreveda d-dejta kollha disponibbli minn studji kliniċi, letteratura ppubblikata, u esperjenza wara tqegħid fis-suq dwar is-sigurtà tal-prodotti li fihom diacerein, b'mod partikolari fir-rigward tarriskju ta' epatotossiċità, disturbi gastrointestinali u disturbi fil-ġilda.
English: A laxative effect was observed in up to 50% of the diacerein-treated patients in clinical studies.
Maltese: Fl-istudji kliniċi kien osservat effett lassattiv f'sa 50% tal-pazjenti li rċevew kura b'diacerein.
English: The correct diagnosis includes both clinical and radiological criteria.
Maltese: Id-dijanjosi korretta tinkludi kemm kriterji kliniċi kif ukoll radjoloġiċi.
English: Re-examination procedure
Maltese: Kwistjonijiet ta' effikaċja
English: With regards to the safety profile of diacerein, it was noted that the most frequently reported events with diacerein when used as per label (100mg/day) in the clinical trials, were loose stools and diarrhoea, including severe diarrhoea.
Maltese: Fir-rigward tal-profil tas-sigurtà ta' diacerein, ġie nnotat li fil-provi kliniċi, l-avvenimenti l-aktar irrapportati b'mod frekwenti b'diacerein meta ntuża skont it-tikketta (100mg/kuljum), kienu ippurgar maħlul u dijarea, inkluż dijarea severa.
English: About 10% of adverse drug reactions (ADR) reported were hepatic disorders and in over 68% of these cases, diacerein was the only drug suspected.
Maltese: Madwar 10% tar-reazzjonijiet avversi għall-mediċina (ADR) irrapportati kienu disturbi epatiċi u f'aktar minn 68% ta' dawn il-każijiet, diacerein kien l-uniku mediċina suspettata.
English: Some studies revealed that 25% patients with diarrhoea during diacerein treatment experienced chronic diarrhoeas, defined by diarrhoea persisting more than 4 weeks.
Maltese: Xi studji wrew li 25% tal-pazjenti b'dijarea waqt il-kura b'diacerein esperjenzaw dijarea kronika, definita bħala dijarea li tippersisti għal aktar minn 4 ġimgħat.
English: • The PRAC considered that the available data supporting the use of diacerein have shown a modest but statistically significant effect in the treatment of osteoarthritis of the knee and hip, with a delayed effect.
Maltese: • Il-PRAC qies li d-dejta disponibbli li tappoġġja l-użu ta diacerein uriet effett modest iżda statistikament sinifikanti fil-kura ta' osteoartrite tal-irkoppa u tal-ġenbejn, b'effett ittardjat.
English: However, the quality of the studies was heterogeneous and publication bias could not be excluded since only published trials and nonpublished trials sponsored by the companies were included in the systematic reviews.
Maltese: Madankollu, il-kwalità tal-istudji kienet eteroġena u ma setax jiġi eskluż preġudizzju tal-pubblikazzjoni peress li fir-reviżjonijiet sistematiċi ġew inklużi biss provi ppubblikati u provi mhux ippubblikati sponsorjati mill-kumpaniji.
English: • The PRAC reviewed all the available data on the efficacy and safety of diacerein-containing medicines in particular data in relation to the risk of hepatotoxicity, gastrointestinal disorders and cutaneous reactions provided by the MAHs in writing and in the oral explanations;
Maltese: • Il-PRAC irreveda d-dejta kollha disponibbli dwar l-effikaċja u s-sigurtà tal-mediċini li fihom diacerein b'mod partikolari d-dejta fir-rigward tar-riskju ta' epatotossiċità, disturbi gastrointestinali u reazzjonijiet tal-ġilda pprovduti mill-MAHs bil-miktub u fl-ispjegazzjonijiet orali;
English: In addition, and according to the clinical trials and bibliographical data, the efficacy appeared weak in the symptomatic treatment of osteoarthritis with low impact on pain and functional symptoms and with no demonstration of a decrease of NSAIDs intake in the population treated with diacerein.
Maltese: Barra minn hekk, u skont il-provi kliniċi u d-dejta bibljografika, l-effikaċja dehret dgħajfa fil-kura sintomatika tal-osteoartrite b'impatt baxx fuq l-uġigħ u s-sintomi funzjonali u bl-ebda dimostrazzjoni ta' tnaqqis fit-teħid ta' NSAIDs fil-popolazzjoni li kienet qed tingħata kura b'diacerein.
English: Furthermore, evidence of hepatic reactions was reported, including symptomatic acute liver injury.
Maltese: Barra minn hekk, ġiet irrapportata evidenza ta' reazzjonijiet epatiċi, inkluż ħsara sintomatika akuta fil-fwied.
English: The PRAC acknowledged that although neither the available randomised clinical trials nor the metaanalyses were without flaws, clinical trials show a modest and statistically significant effect for diacerein in the end-points pain relief and function disability.
Maltese: Il-PRAC irrikonoxxa li għalkemm la l-provi kliniċi każwali disponibbli u lanqas il-meta-analiżi ma kienu mingħajr difetti, il-provi kliniċi juru effett modest u statistikament sinifikanti għal diacerein fil-punti aħħarin ta' serħan mill-uġigħ u diżabbiltà funzjonali.
English: The CMDh, having considered the revised final PRAC recommendation dated 10 July 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of diacerein containing medicinal products for which the amendments to the product information are set out in annex III and subject to the condition set out in Annex IV.
Maltese: Is-CMDh, wara li qies ir-rakkomandazzjoni finali riveduta tal-PRAC datata l-10 ta' Lulju 2014 skont lArtikolu 107k(1) u (2) tad-Direttiva 2001/83/KE, laħaq pożizzjoni dwar il-varjazzjoni talawtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali li fihom diacerein li għalihom l-emendi għall-informazzjoni dwar il-prodott huma stabbiliti fl-anness III u soġġetti għall-kondizzjoni stabbilita fl-Anness
English: Finally, several double-blind randomised clinical trials analysed the alleged NSAID sparing effect of diacerein as a secondary endpoint.
Maltese: Fl-aħħar nett, diversi provi kliniċi bi blindaġġ doppju u każwali analizzaw l-allegat effett ta' NSAID li jevita l-użu ta' diacerein bħala punt aħħari sekondarju.
English: • The PRAC considered the grounds for re-examination provided by the MAHs in writing and in the oral explanations;
Maltese: • Il-PRAC qies ir-raġunijiet għal eżaminazzjoni mill-ġdid ipprovduti mill-MAHs bil-miktub u flispjegazzjonijiet orali;
English: With regards to the risk of gastrointestinal disorders, diarrhoea was a common and expected reaction of diacerein.
Maltese: Fir-rigward tar-riskju ta' disturbi gastrointestinali, id-dijarea kienet reazzjoni komuni u mistennija ta' diacerein.
English: Double blind placebo controlled clinical trials performed during the last 20 years showed heterogeneous results, which may be explained by the usual high placebo effect in this kind of indications.
Maltese: Provi kliniċi bi blindaġġ doppju u kkontrollati bi plaċebo li saru matul l-aħħar 20 sena wrew riżultati eteroġenji, li jistgħu jiġu spjegati mill-effett normalment għoli tal-plaċebo f'dan it-tip ta' indikazzjonijiet.
English: Based on the totality of the data available on the safety and the efficacy of diacerein, and considering all the risk minimisation measures proposed during assessment and the re-examination procedure, the PRAC concluded that the benefit-risk balance of diacerein-containing medicinal products remained favourable in the symptomatic treatment osteoarthritis, subject to changes to the product information and conditions.
Maltese: Abbażi tat-totalità tad-dejta disponibbli dwar is-sigurtà u l-effikaċja ta' diacerein, u jitqiesu l-miżuri kollha ta' minimizzazzjoni tar-riskji proposti waqt il-valutazzjoni u l-proċedura ta' eżaminazzjoni millġdid, il-PRAC ikkonkluda li l-bilanċ tal-benefiċċju-riskju ta' prodotti mediċinali li fihom diacerein baqa' favorevoli fil-kura sintomatika ta' osteoartrite, soġġett għal tibdil fl-informazzjoni dwar il-prodott u lkundizzjonijiet.
English: Xospata is available as tablets (40 mg).
Maltese: Xospata jiġi bħala pilloli (40 mg).
English: The active substance in Xospata is gilteritinib.
Maltese: Is-sustanza attiva fi Xospata hija gilteritinib.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3171961.
Maltese: ema.europa.eu/medicines/human/orphan-designations/eu3171961
English: Other information about Xospata
Maltese: Informazzjoni oħra dwar Xospata
English: The most common side effects with Xospata (which may affect more than 1 in 10 people) are increased levels of some enzymes in the blood (creatine phosphokinase, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase), diarrhoea, tiredness, nausea (feeling sick), constipation, cough, peripheral oedema (swelling, especially of the ankles and feet), dyspnoea (shortness of breath), dizziness, hypotension (low blood pressure), pain in the extremities, weakness, joint pain and muscle pain.
Maltese: L-effetti sekondarji l-aktar komuni bi Xospata (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma żieda fil-livelli ta' xi enzimi fid-demm (kreatina fosfokinażi, alanina aminotransferażi, aspartat aminotransferażi, alkalina fosfatażi), dijarea, għeja, nawżja (tħossok ma tiflaħx), stitikezza, sogħla, edema periferika (nefħa, speċjalment tal-għekiesi u s-saqajn), dispnea (qtugħ ta' nifs), sturdament, ipotensjoni (pressjoni tad-demm baxxa), uġigħ fl-estremitajiet, dgħjufija, uġigħ fil-ġogi u wġigħ filmuskoli.
English: Patients receiving Xospata lived on average 9.3 months compared with 5.6 months for those receiving various types of chemotherapy.
Maltese: Il-pazjenti li rċevew Xospata għexu medja ta' 9.3 xhur meta mqabbla ma' 5.6 xhur għal dawk li rċevew diversi tipi ta' kimoterapija.
English: AML is rare, and Xospata was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 January 2018.
Maltese: L-AML hija rari, u Xospata ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis17 ta' Jannar 2018.
English: What are the risks associated with Xospata?
Maltese: X'inhuma r-riskji assoċjati ma' Xospata?
English: Further information on Xospata can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/xospata This overview was last updated in 10-2019.
Maltese: ema.europa.eu/medicines/human/EPAR/xospata
English: Xospata is a cancer medicine used to treat adults with acute myeloid leukaemia (AML), a cancer of white blood cells.
Maltese: Xospata huwa mediċina kontra l-kanċer li tintuża biex tikkura adulti b'lewkimja tal-majelojde akuta (AML, acute myeloid leukaemia), kanċer taċ-ċelloli bojod tad-demm.
English: The active substance in Xospata, gilteritinib, blocks the action of enzymes known as tyrosine kinases, in particular a tyrosine kinase called FLT3 which normally controls growth and division of white blood cells.
Maltese: Is-sustanza attiva fi Xospata, il-gilteritinib, timblokka l-azzjoni ta' enzimi magħrufa bħala tirożina kinażi, b'mod partikolari tirożina kinażi msejħa FLT3 li normalment tikkontrolla t-tkabbir u d-diviżjoni taċ-ċelloli bojod tad-demm.
English: In a main study with 371 patients with AML who have an FLT3 mutation, and whose disease had come back or had not improved following previous treatment, Xospata prolonged patients' lives compared with patients receiving chemotherapy.
Maltese: Fi studju ewlieni bi 371 pazjent b'AML li għandhom mutazzjoni FLT3, u li l-marda tagħhom reġgħet feġġet jew ma kinitx tjiebet wara kura preċedenti, Xospata tawwal il-ħajja tal-pazjenti meta mqabbla ma' pazjenti li rċevew il-kimoterapija.
English: The company that markets Xospata will provide educational materials to healthcare professionals and patients about the signs and symptoms of differentiation syndrome.
Maltese: Il-kumpanija li tqiegħed Xospata fis-suq se tipprovdi materjal edukattiv lill-professjonisti fil-qasam talkura tas-saħħa u lill-pazjenti dwar is-sinjali u s-sintomi tas-sindrome ta' differenzjazzjoni.