FrancophonIA/ELRC3.0 huggingface dataset:
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju u r-riskju talprodott mediċinali.
English: Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Każijiet rari ta' effetti tossiċi fuq il-widna, nuqqas u/jew telf tas-smigħ kienu irrapportati.
English: • Docetaxel Teva Pharma 80 mg vial 15 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Maltese: • Is-solvent għal Docetaxel 80 mg huwa f'kunjett tal-ħġieġ ċar ta' 15 ml u li għandu tapp trasparenti u mingħajr kulur, li jinfetaħ billi tgħollih.
English: Lacrimation increased (G3/4: <0.1%)
Maltese: Żieda fid-dmugħ (G3/4: <0.1%)
English: Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Maltese: L-aħħar stadji sekondarji tal-proċess kienu jinkludu bidla fl-uġigħ, ir-rata globali tal-kwalità talħajja bl-użu tal-EuroQoL-5D, Skala ta' Sintomi għall-Kanċer tal-Pulmun, u bidliet fl-istatus talwirja ta' Karnosfky.
English: Preparation for the intravenous administration a)
Maltese: 1 ġimgħa.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl Għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali dilwit, ara sezzjoni 6.3.
English: What Docetaxel Teva Pharma is and what it is used for What you need to know before you use Docetaxel Teva Pharma How to use Docetaxel Teva Pharma Possible side effects
Maltese: Is-severità ta' dawn il-ġrajjiet avversi ta' Docetaxel Teva Pharma jistgħu jiżdiedu meta Docetaxel Teva Pharma jingħata flimkien ma' sustanzi kimoterapewtiċi oħra.
English: Venous disorder (G3/4: 0.6%)
Maltese: Disturbi fil-vini (G3/4:0.6%)
English: Thrombocytopenia (G3/4: 1.6%);
Maltese: Uġigħ tal-kanċer (G3/4:1.2%)
English: Cardiac left ventricular function decrease (G3/4: 0.3%)
Maltese: Tnaqqis fil-funzjoni ventrikulari tax-xellug tal-qalb (G3/4: 0.3%)
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg per vial.
Maltese: Din iż-żieda fil-volum tiżgura li, wara li ssir it-taħlita tal-kontenut sħiħ tal-kunjett tas-solvent mal-kontenut kollu tal-kunjett ta'docetaxel, ikun hemm ammont minimu li jista' jittella' ta' 8 ml, li għandu 10 mg/ml docetaxel, li jikkorrispondi għallammont indikat fuq it-tabella ta' 80 mg kull kunjett.
English: Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Maltese: Stomatite (G3/4: 23.7%); Rimettar (G3/4: 14.
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with cisplatin
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal Docetaxel 75 mg/m² użat flimkien ma' cisplatin:
English: Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Maltese: Majalġja (G3/4: 0.7%); Artralġja (G3/4: 0.2%)
English: Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3.
Maltese: Docetaxel ma jistax jintuża f'pazjenti fejn il-livell ta' riferiment bażiku tal-għadd taċ-ċelluli newtrofiliċi fid-demm huwa < 1,500 ċelluli/mm
English: In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Maltese: Fil-qasam talistudji fejn docetaxel intuża flimkien ma' trastuzumab, 64% kienu ħadu qabel anthracycline bħala terapija miżjuda, meta mqabbel ma' 55% tal-fergħa ta' docetaxel biss.
English: In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from
Maltese: F'pazjenti li kellhom jew id-deni flimkien man-newtropenija, b'għadd ta' newtrofili ta' <500 ċelluli/mm għal aktar minn ġimgħa, jew reazzjonijiet severi jew kumulattivi fil-ġilda, jew newropatija severa u periferika, waqt it-terapija bid-docetaxel, id-doża ta' docetaxel trid titnaqqas minn 100 mg/m2.
English: Docetaxel Teva Pharma will be administered to you by a healthcare professional.
Maltese: Docetaxel Teva Pharma sejjer jingħatalek minn professjonist fil-qasam tas-saħħa.
English: Gastrointestinal haemorrhage (G3/4: 0.4%)
Maltese: Disturbi gastrointestinali Stomatite (G3/4: 5.3%);
English: Rash pruritus; Dry skin;
Maltese: Uġigh fil-parti ta' fuq taż-żaqq;
English: • nasal drainage; inflammation of the throat and nose; cough
Maltese: • tnixxija tal-imnieħer; infjammazjoni tal-gerżuma u l-imnieħer; sogħla
English: • The solvent for Docetaxel composition is water for injections.
Maltese: • Is-solvent għal Docetaxel huwa ilma għall-injezzjonijiet.
English: Docetaxel Teva Pharma is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Teva Pharma solutions.
Maltese: Docetaxel Teva Pharma hija sustanza kimika għall-użu kontra t-tumuri u, bħal kull sustanza potenzjalment tossika, trid tkun eżerċitata l-kawtela fl-immaniġġar u fil-preparazzjoni tat-taħlitiet ta' Docetaxel Teva Pharma.
English: Between infusions of Docetaxel Teva Pharma the following may occur, and the frequency may vary with the combinations of medicines that are received:
Maltese: Bejn infużjoni u oħra ta' Docetaxel Teva Pharma jista' jkollu dawn l-effetti, li l-frekwenza tagħhom tvarja skont it-taħlita ta' mediċini li qed tieħu:
English: • one 15 ml clear glass vial with a flip-off cap containing 5.12 ml of solvent.
Maltese: • kunjett tal-ħġieġ ċar ta' 15 ml b'għatu li jinqala' bis-suba' li fih 5.12 ml ta' solvent.
English: Cutaneous reactions
Maltese: U KWANTITATTIVA
English: Neutropenia (G3/4: 83.5%);
Maltese: Stomatite (G3/4: 18%);
English: What Docetaxel Teva Pharma looks like and contents of the pack: Docetaxel Teva Pharma concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution.
Maltese: Jekk konċentrat ta'Docetaxel Teva Pharma, jew is-soluzzjoni inizjali tal-infużjoni jew l-infużjoni nfisha tiġi f'kuntatt mal-ġilda, aħsel immedjatament u sew bis-sapun u l-ilma.
English: Fluid retention is cumulative in incidence and severity (see section 4.4).
Maltese: Iż-żamm tal-fluwidu jista' jkun kumulattiv fl-inċidenza u s-severità (ara sezzjoni 4.4).
English: Whereas
Maltese: SUSTAIN:
English: As of November 2017, 2,251 patients had received Zinbryta in the clinical development program.
Maltese: Minn Novembru 2017, 2,251 pazjent irċevew Zinbryta fil-programm ta' żvilupp kliniku.
English: In the European Union, as of 30 November 2017, daclizumab beta has been marketed in Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Norway, Poland, Slovenia, Sweden and United Kingdom.
Maltese: Fl-Unjoni Ewropea, sa mit-30 ta' Novembru 2017, daclizumab beta ġie kkummerċjalizzat fl-Awstrija, fil-Belġju, fidDanimarka, fil-Finlandja, fil-Ġermanja, fl-Irlanda, fl-Italja, fin-Netherlands, fin-Norveġja, fil-Polonja, fis-Slovenja, fl-Iżvezja u fir-Renju Unit.
English: Zinbryta (daclizumab beta) has been authorised in the European Union (EU) since 1 July 2016.
Maltese: Zinbryta (daclizumab beta) ilu awtorizzat fl-Unjoni Ewropea (UE) sa mill-1 ta' Lulju 2016.
English: It was initially indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
Maltese: Fil-bidu ġie indikat f'pazjenti adulti għall-kura ta' forom ta' rikaduta ta' sklerożi multipla (RMS).
English: Daclizumab beta binds to the alpha-subunit (CD25) of the high-affinity interleukin-2 (IL-2) receptor.
Maltese: Daclizumab beta jingħaqad mas-subunità-alfa (CD25) tar-riċettur ta' interleukin-2 (IL-2) b'affinità għolja.
English: There are no active patients;
Maltese: Ma hemmx pazjenti attivi;
English: Daclizumab beta blocks CD25 (alfa subunit of high affinity IL-2 receptor), decreasing the number and function of CD4+CD25+FoxP3+Treg and produces an activation and expansion of CD56 NK cells.
Maltese: Daclizumab beta jimblokka s-CD25 (subunità alfa tar-riċettur ta' IL-2 b'affinità għolja), u b'hekk inaqqas l-għadd u l-funzjoni ta' CD4+CD25+FoxP3+Treg u jipproduċi attivazzjoni u espansjoni ta' ċelloli NK CD56.
English: In the second PSUR (period from 27 November 2016 - 26 May 2017), the review of autoimmune encephalitis cases and other immune-related disorders cases showed that there was a wide variety of immune-mediated disorders reported (such as encompassed seronegative arthritis, blood dyscrasias, thyroid disorders, glomerulonephritis and skin and subcutaneous disorders).
Maltese: Fit-tieni PSUR (perjodu mis-27 ta' Novembru 2016 - 26 ta' Mejju 2017), ir-reviżjoni ta' każijiet ta' enċefalite awtoimmuni u ta' każijiet oħra ta' disturbi relatati mas-sistema immunitarja wrew li kien hemm varjetà wiesgħa ta' disturbi medjati mis-sistema immunitarja rrapportati (bħall-artrite seronegattiva, abnormalitajiet tad-demm, disturbi fit-tirojde, glomerulonefrite u disturbi fil-ġilda u fittessuti ta' taħt il-ġilda).
English: ZEUS: non-interventional study in Germany with 609 patients enrolled currently.
Maltese: ZEUS: studju mingħajr intervent fil-Ġermanja b'609 pazjenti attwalment reġistrati.
English: On 20 February 2018, the Paul Ehrlich Institute (PEI) informed the EMA about five patients who were treated in 2016 and 2017 with daclizumab beta in Germany, and experienced worsening of disease after initiation of therapy.
Maltese: Fl-20 ta' Frar 2018, il-Paul Ehrlich Institute (PEI) informa lill-EMA dwar ħames pazjenti li kienu ngħataw kura b'daclizumab beta fl-2016 u fl-2017 fil-Ġermanja, u li esperjenzaw aggravar tal-marda wara l-bidu tat-terapija.
English: Autoimmune haemolytic anemia is already known to be related to daclizumab beta treatment.
Maltese: L-anemija emolitika awtoimmuni diġà hija magħrufa li hija relatata mal-kura b'daclizumab beta.
English: Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab beta in multiple sclerosis (MS) include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
Maltese: L-effetti ewlenin ta' din il-modulazzjoni tal-passaġġ ta' IL-2 potenzjalment relatata mal-effetti terapewtiċi ta' daclizumab beta fl-isklerożi multipla (SM) jinkludu antagoniżmu selettiv tar-rispons taċ-ċelloli T attivati, u l-espansjoni ta' ċelluli qattiela naturali (NK) CD56 bright immunoregolatorji, li ntwera li jnaqqsu b'mod selettiv iċ-ċelloli T attivati.
English: • The PRAC reviewed the totality of the available data, including data provided by the marketing authorisation holder in writing and in an oral explanation on the 12 cases of serious encephalitis and meningo-encephalitis (of which three fatal) reported since the initial marketing authorisation and safety data from clinical trials, in relation to the overall risk of immune-mediated disorders with CNS involvement during treatment with Zinbryta.
Maltese: • Il-PRAC irreveda t-totalità tad-data disponibbli, inkluża d-data pprovduta mid-detentur talawtorizzazzjoni għat-tqegħid fis-suq bil-miktub u fi spjegazzjoni orali dwar it-12-il każ ta' enċefalite serja u ta' meningoenċefalite (li tlieta minnhom kienu fatali) irrapportati millawtorizzazzjoni inizjali għat-tqegħid fis-suq kif ukoll data dwar is-sigurtà minn provi kliniċi, firrigward tar-riskju globali ta' disturbi medjati mis-sistema immunitarja b'involviment tas-CNS waqt il-kura b'Zinbryta.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Zinbryta, in particular the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004, taking into account the grounds set out in Articles 116 and 117 of Directive 2001/83/EC.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat ta' data dwar il-farmakoviġilanza għal Zinbryta, b'mod partikolari rigward il-ħtieġa għal miżuri proviżorji skont l-Artikolu 20(3) tar-Regolament (KE) Nru 726/2004, filwaqt li jitqiesu rraġunijiet stabbiliti fl-Artikoli 116 u 117 tad-Direttiva 2001/83/KE.
English: Together, these immunomodulatory effects of daclizumab beta are believed to reduce central nervous system (CNS) pathology in MS and thereby reduce the occurrence of relapses and disability progression.
Maltese: Flimkien, dawn l-effetti immunomodulatorji ta' daclizumab beta huma maħsuba li jnaqqsu l-patoloġija tas-sistema nervuża ċentrali (CNS) fl-SM u b'hekk inaqqsu l-okkorrenza ta' rikaduti u l-progressjoni tad-diżabilità.
English: From the third PSUR (period from 27 May 2017 - 26 November 2017), there have also been some cases of unexpected deaths, attributed to cerebrovascular accidents, but with no detailed information on them that would conclusive allow for the exclusion of encephalitis.
Maltese: Mit-tielet PSUR (perjodu mis-27 ta' Mejju 2017 - 26 ta' Novembru 2017), kien hemm ukoll xi każijiet ta' mwiet mhux mistennija, attribwiti għal aċċidenti ċerebrovaskulari, iżda ma kienx hemm informazzjoni dettaljata dwarhom li tippermetti l-esklużjoni konklussiva ta' enċefalite.
English: Daclizumab beta is a humanised IgG1 monoclonal antibody that modulates IL-2 signalling by blocking CD25-dependent, high affinity IL-2 receptor signalling, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor.
Maltese: IgG1 umanizzat li jimmodula s-sinjalar ta' IL-2 billi jimblokka s-sinjalar ta' riċetturi ta' IL-2 b'affinità għolja, dipendenti fuq is-CD25, li jwassal għal livelli ogħla ta' IL-2 disponibbli għal sinjalar permezz tar-riċettur ta' IL-2 b'affinità intermedja.
English: All cases were spontaneous reports, except for the Spanish case which came from an extension of a clinical trial.
Maltese: Il-każijiet kollha kienu rapporti spontanji, ħlief għall-każ Spanjol li ġie minn estensjoni ta' prova klinika.
English: These cases concerned 10 females, 1 male (and 1 unknown), aged between 30 and 69 years-old; 9 cases occurred in Germany, 2 in USA and 1 in Spain.
Maltese: Dawn il-każijiet kienu jinkludu 10 nisa, raġel 1 (u każ 1 mhux magħruf), ta' bejn it-30 u d-69 sena; 9 każijiet seħħew fil-Ġermanja, 2 fl-Istati Uniti tal-Amerka u 1 fi Spanja.
English: Three of these cases had a fatal outcome, 2 cases are still intubated, 1 has an Expanded Disability Status Scale (EDSS) score 9.5, 1 recovered with sequelae, 1 partially recovered, and the remaining cases had an unknown outcome.
Maltese: Tlieta minn dawn il-każijiet kellhom eżitu fatali, 2 każijiet għadhom intubati, 1 għandu punteġġ ta' 9.5 fuq l-Iskala tal-Istat Mifrux tad-Diżabilità (EDSS), 1 irkupra b'sintomi bħala konsegwenza tal-marda, 1 irkupra parzjalment, u l-eżitu tal-każijiet li fadal mhuwiex magħruf.
English: In summary, 12 cases of serious and potentially fatal immune-mediated events involving CNS, with symptoms initially compatible with relapse of MS and later on explained by unexpected findings in the neuropathology, with a predominantly inflammatory process and eosinophilic granulocytes, were reported.
Maltese: Fil-qosor, ġew irrapportati 12-il każ ta' avvenimenti serji u potenzjalment fatali medjati mis-sistema immunitarja li jinvolvu s-CNS, b'sintomi inizjalment kompatibbli mar-rikaduta ta' SM u aktar tard spjegati minn sejbiet mhux mistennija fin-newropatoloġija, bi proċess predominanti infjammatorju u granuloċiti oesofiniliċi.
English: PRAC concluded that these adverse reactions could be causally associated with Zinbryta.
Maltese: Il-PRAC ikkonkluda li dawn ir-reazzjonijiet avversi jistgħu jkunu kawżalment assoċjati ma' Zinbryta.
English: It is plausible that the immunomodulatory effects of the drug are involved in immune-mediated adverse effects, such as autoimmune hepatitis, and could be related to the reported cases of encephalitis and/or meningoencephalitis.
Maltese: Huwa plawsibbli li l-effetti immunomodulatorji tal-mediċina huma involuti fl-effetti negattivi medjati mis-sistema immunitarja, bħall-epatite awtoimmuni, u jistgħu jkunu relatati malkażijiet ta' enċefalite u/jew ta' meningoenċefalite rrapportati.
English: Immune-mediated or autoimmune conditions such as type I diabetes, colitis, autoimmune thyroiditis, pancreatitis, glomerulonephritis, among other, were reported in low numbers.
Maltese: Kien hemm għadd żgħir ta' rapporti ta' kundizzjonijiet awtoimmuni jew medjati mis-sistema immunitarja bħal fost oħrajn, dijabete tat-tip I, kolite, tirojodite awtoimmuni, pankreatite u glomerulonefrite.
English: A PRAC review concluded on 31 October 2017 (due to cases of immune-mediated liver injury) led to the restriction of indication to the treatment of adult patients with relapsing forms of multiple sclerosis who have had an inadequate response to at least two disease modifying therapies (DMTs) and for whom treatment with any other DMT is contraindicated or otherwise unsuitable.
Maltese: Reviżjoni tal-PRAC konkluża fil-31 ta' Ottubru 2017 (minħabba każijiet ta' ħsara fil-fwied medjata mis-sistema immunitarja) waslet għar-restrizzjoni tal-indikazzjoni għall-kura ta' pazjenti adulti b'forom ta' rikaduta ta' sklerożi multipla li fil-passat kellhom rispons inadegwat għal minn tal-inqas żewġ terapiji li jimmodifikaw il-marda (DMTs) u li għal min kura bi kwalunkwe DMT oħra hija kontraindikata jew inkella mhijiex adegwata.
English: The postmarketing exposure in the European Economic Area (EEA) is estimated at 3,290 patients (of which around 2,890 patients in Germany) and worldwide at 5,086 patients.
Maltese: L-esponiment ta' wara t-tqegħid fis-suq fiż-Żona Ekonomika Ewropea (ŻEE) huwa stmat li hu ta' 3,290 pazjent (li minnhom madwar 2,890 pazjent fil-Ġermanja) u fid-dinja kollha 5,086 pazjent.
English: In light of all of the above and having carefully assessed all available data, PRAC considered at this stage that the benefit-risk balance of the product is no longer favourable and that urgent measures in accordance with Article 20(3) of Regulation (EC) No 726/2004, taking into account the grounds set out in Articles 116 and 117 of Directive 2001/83/EC, are needed to protect patients.
Maltese: Fid-dawl ta' dak kollu li ntqal hawn fuq u wara li vvaluta bir-reqqa d-data kollha disponibbli, il-PRAC qies li f'dan l-istadju lbilanċ bejn ir-riskji u l-benefiċċji tal-prodott ma għadux aktar favorevoli u li hemm bżonn ta' miżuri urġenti skont l-Artikolu 20(3) tar-Regolament (KE) Nru 726/2004, filwaqt li jitqiesu r-raġunijiet stabbiliti fl-Artikoli 116 u 117 tad-Direttiva 2001/83/KE, biex jiġu mħarsa l-pazjenti.
English: On 26 February 2018, pursuant to Article 20 of Regulation (EC) No 726/2004, the European Commission requested the opinion of the Agency on whether the marketing authorisation of Zinbryta should be maintained, varied, suspended or revoked.
Maltese: Fis-26 ta' Frar 2018, skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004, il-Kummissjoni Ewropea talbet l-opinjoni tal-Aġenzija dwar jekk l-awtorizzazzjoni għat-tqegħid fis-suq ta' Zinbryta għandhiex tinżamm, tinbidel, tiġi sospiża jew revokata.
English: PRAC has considered carefully the above described cases, the probable mechanism of action for these adverse events, along with the potential for auto-immune or immune-mediated reactions that appears associated with Zinbryta, the product mechanism of action, the biological plausibility, and that no risk minimisation measures (RMMs) can be foreseeable to prevent occurrence of these risks in patients on treatment with daclizumab beta at this stage.
Maltese: Il-PRAC qies bir-reqqa l-każijiet deskritti hawn fuq, il-mekkaniżmu ta' azzjoni probabbli għal dawn lavvenimenti avversi, flimkien mal-potenzjal għal reazzjonijiet awtoimmuni jew medjati mis-sistema immunitarja li jidhru assoċjati ma' Zinbryta, il-mekkaniżmu ta' azzjoni tal-prodott, il-plawsibilità bijoloġika, u li f'dan l-istadju ma hemm prevista l-ebda attività tal-imminimizzar tar-riskju (RMMs) biex tiġi evitata l-okkorrenza ta' dawn ir-riskji f'pazjenti fuq kura b'daclizumab beta.
English: Due to the conclusion of the previous referral and based on the clinical characteristics of the patients, the MAH has already decided in January 2018 to stop this trial by 30 March 2018;
Maltese: Minħabba l-konklużjoni tar-riferiment preċedenti u abbażi tal-karatteristiċi kliniċi tal-pazjenti, f'Jannar 2018 il-MAH kien diġà ddeċieda li sat-30 ta' Marzu 2018 din il-prova titwaqqaf;
English: • Furthermore, PRAC recommended that a healthcare professional communication should be disseminated to inform healthcare professionals about the risks related to Zinbryta and provide instructions related to the cessation of the treatment and the follow-up of patients having received Zinbryta.
Maltese: • Barra minn hekk, il-PRAC irrakkomanda t-tixrid ta' komunikazzjoni għall-professjonali fil-qasam tal-kura tas-saħħa biex dawn jiġu mgħarrfa dwar ir-riskji relatati ma' Zinbryta u sabiex jingħataw struzzjonijiet relatati mal-waqfien tal-kura u mas-segwitu tal-pazjenti li jkunu rċevew Zinbryta.
English: At least 5 of these patients had clinical symptoms compatible with ‘drug rash with eosinophilia and systemic symptoms' (DRESS) syndrome, one of which was confirmed with skin biopsy and one highly suspected.
Maltese: Tal-anqas ħamsa minn dawn il-pazjenti kellhom sintomi kliniċi kompatibbli ma' ‘raxx minħabba l-mediċina b'eosinofilja u sintomi sistemiċi' (DRESS), u każ minnhom kien ikkonfermat permezz ta' bijopsija tal-ġilda u f'każ wieħed kien hemm suspett kbir ta' dan.
English: Administration of acute corticosteroids and/or plasmapheresis did not improve the clinical situation, brain biopsies were obtained, which showed an unexpected finding of massive inflammation with eosinophilic granulocytes (unexpected in MS patients).
Maltese: L-għoti ta' kortikosterojdi u/jew ta' plażmafereżi akuti ma tejbux is-sitwazzjoni klinika; inkisbu bijopsiji tal-moħħ, li wrew sejba mhux mistennija ta' infjammazzjoni massiva bi granuloċiti oesofiniliċi (mhux mistennija f'pazjenti b'SM).
English: SUSTAIN: A phase 3b open label study to assess efficacy and safety of daclizumab beta in patients switching from natalizumab in 5 countries, 3 in EU (DE, IT and UK).
Maltese: Studju bi prova miftuħa tal-fażi 3b biex tiġi vvalutata l-effikaċja u s-sigurtà ta' daclizumab beta f'pazjenti li jaqilbu minn natalizumab f'ħames pajjiżi, tlieta fl-UE (DE, IT u r-Renju Unit).
English: It is administered as 150 mg dose subcutaneously once a month.
Maltese: Jiġi amministrat bħala doża ta' 150 mg taħt il-ġilda darba fix-xahar.
English: Daclizumab beta is hypothesized to exert its activity in MS through immunomodulatory mechanisms.
Maltese: Il-MAH kien intalab jipprovdi aktar informazzjoni dwar dawn l-avvenimenti medjati mis-sistema immunitarja fit-tielet PSUR.
English: Further information on Ilumetri can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni fuq Ilumetri tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Ilumetri
Maltese: Informazzjoni oħra dwar Ilumetri
English: Patients do not experience many side effects.
Maltese: Il-pazjenti ma jesperjenzawx ħafna effetti sekondarji.
English: The active substance in Ilumetri, tildrakizumab, is a monoclonal antibody (a type of protein) which is designed to attach to interleukin 23 and block its activity.
Maltese: Is-sustanza attiva f'Ilumetri, it-tildrakizumab, hija antikorp monoklonali (tip ta' proteina) li hija mfassla biex teħel ma' interleukin 23 u timblokka l-attività tiegħu.
English: The second study involving 1,090 patients compared Ilumetri with placebo and with etanercept (another psoriasis medicine).
Maltese: It-tieni studju li involva 1,090 pazjent qabbel Ilumetri ma' plaċebo u ma' etanercept (mediċina oħra ta' kontra l-psorjasi).