FrancophonIA/ELRC3.0 huggingface dataset:
English: Finland considered that ineffective treatment of mycoplasma mastitis with tylosin presents a serious concern to animal and public health as it delays the correct diagnosis, enables spread of the pathogen to other cows, impedes efficient/prudent control measures and increases risk for the development of antimicrobial resistance due to unnecessary use of antimicrobials.
Maltese: Il-Finlandja kkunsidrat li kura ineffettiva ta' mastite bil-mikoplażma b'tylosin tippreżenta tħassib serju dwar is-saħħa tal-annimali u pubblika peress li din iddewwem id-dijanjożi korretta, tippermetti t-tixrid tal-patoġenu lil baqar oħrajn, timpedixxi miżuri ta' kontroll effiċjenti/prudenti u żżid ir-riskju għalliżvilupp ta' reżistenza antimikrobika minħabba l-użu mhux meħtieġ tal-antimikrobiċi.
English: Why were veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Maltese: Għaliex ġew riveduti prodotti mediċinali veterinarji li fihom tylsoin li jingħataw b' mod parenterali u li huma intiżi għall-kura ta' mastite bovina kkawżata minn Mycoplasma spp.?
English: In the absence of submitted proprietary pre-clinical or clinical data for the products in the scope of this referral in support of the respective indication, the CVMP considered scientific references on efficacy.
Maltese: Fin-nuqqas tad-data preklinka jew klinika ta' proprjetà ppreżentata għall-prodotti fil-kamp ta' applikazzjoni ta' dan ir-riferiment b'appoġġ għall-indikazzjoni rispettiva, is-CVMP kkunsidra referenzi xjentifiċi dwar l-effikaċja.
English: The Committee recommended variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products in order to remove the indications ‘bovine mastitis caused by Mycoplasma spp.'
Maltese: Il-Kumitat irrakkomanda varjazzjonijiet għat-termini talawtorizzazzjoni għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji msemmija hawn fuq sabiex jitneħħew l-indikazzjonijiet "mastite bovina kkawżata minn Mycoplasma spp."
English: Based on the evaluation of the currently-available data, the CVMP concluded that, in the absence of specific pre-clinical or clinical data, and in light of the current scientific knowledge, the indication for treatment of bovine mastitis caused by Mycoplasma spp.
Maltese: Abbażi tal-evalwazzjoni tad-data disponibbli attwalment, is-CVMP ikkonkluda li, fin-nuqqas ta' data preklinika jew klinika u fid-dawl tal-għarfien xjentifiku attwali, l-indikazzjoni għall-kura ta' mastite bovina kkawżata minn Mycoplasma spp. bi prodotti mediċinali veterinarji li fihom tylosin li jingħataw b' mod parenterali mhijiex appoġġjata.
English: The CVMP was requested to review all available data and to provide its opinion on whether the indication related to 'bovine mastitis caused by Mycoplasma spp.'
Maltese: Is-CVMP irrakkomanda t-tħassir tal-indikazzjonijiet relatati ma' "mastite bovina kkawżata minn Mycoplasma spp." jew "mastite bovina kkawżata minn Mycoplasma bovis' millinformazzjoni tal-prodott għall-prodott ikkonċernat.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in the absence of pre-clinical or clinical data, treatment of bovine mastitis caused by Mycoplasma spp.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li, fin-nuqqas tad-data preklinika jew klinika, il-kura ta' mastite bovina kkawżata minn Mycoplasma spp. bil-prodotti mediċinali veterinarji msemmijin hawn fuq mhijiex effettiva.
English: MA (EU) number
Maltese: Numru MA (UE)
English: Pack size
Maltese: L-ewwel Ippakkjar
English: Ref.: EMEA/632126/2009 EMEA/H/C/974
Maltese: EMEA/632126/2009 EMEA/H/C/974
English: This corresponds to a relative reduction in risk of 9% compared with aspirin.
Maltese: Dan jikkorrispondi għattnaqqis relattiv fir-riskju ta' 9% meta mqabbel mal-aspirina.
English: In CAPRIE, there were 939 events in the Clopidogrel BMS group, and 1,020 in the aspirin group.
Maltese: F'CAPRIE kien hemm 939 każ fil-grupp ta' Clopidogrel BMS, u 1,020 fil-grupp tal-aspirina.
English: In ST segment elevation myocardial infarction, fewer patients on Clopidogrel BMS had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Maltese: F'infart mijokardiku b'elevazzjoni tat-taqsima ST, inqas pazjenti li ngħataw Clopidogrel BMS kellhom każijiet milli fil-pazjenti li ngħataw plaċebo (262 u 377 rispettivament flistudju CLARITY, u 2,121 u 2,310 rispettivament fl-istudju COMMIT).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel BMS to Bristol Myers Squibb Pharma EEIG on 16 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Clopidogre BMS lil Bristol Myers Squibb Pharma EEIG fis-16 ta' Lulju 2008.
English: The most common side effects with Clopidogrel BMS (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured.
Maltese: L-iktar effetti sekondarji komuni ma' Clopidogrel BMS (li dehru f'bejn 1 u 10 pazjent minn kull 100) huma ematoma (ġabra ta' demm taħt il-ġilda), epistassi (fġir tal-imnieħer), emorraġija gastrointestinali (ħruġ ta' demm fiż-żaqq jew fil-musrana), dijarrea, uġigħ addominali (taż-żaqq), dispepsija (indiġestjoni), tbenġil u ħruġ ta' demm fejn il-ġilda tittaqqab.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries);
Maltese: • pazjenti b'mard fl-arterji periferiċi (problemi bil-fluss tad-demm fl-arterji);
English: Clopidogrel BMS is converted into its active form in the body.
Maltese: Clopidogrel BMS jiġi konvertit f'din il-forma attiva fil-ġisem.
English: Clopidogrel BMS is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel BMS huwa mediċina li fiha s-sustanza attiva clopidogrel.
English: In acute coronary syndrome, Clopidogrel BMS is used together with aspirin and treatment generally starts with a loading dose of one 300-mg tablet or four 75-mg tablets.
Maltese: Fis-sindromu koronarju akut, Clopidogrel BMS jintuża mal-aspirina u t-trattament ġeneralment jibda b'doża ta' tagħbija (loading dose) ta' pillola waħda ta' 300 mg jew erba' pilloli ta' 75 mg.
English: In non-ST segment elevation acute coronary syndrome, the overall relative reduction in the risk of an event compared with placebo was 20%.
Maltese: Fis-sindromu koronarju akut mingħajr elevazzjoni tat-taqsima ST, it-tnaqqis relattiv ġenerali fir-riskju ta' każ meta mqabbel ma' plaċebo kien ta' 20 %.
English: The active substance in Clopidogrel BMS, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Clopidogrel BMS, clopidogrel, hu inibitur tal-aggregazzjoni tal-pjastrini (platelets).
English: Clopidogrel BMS was more effective than aspirin at preventing new ischaemic events.
Maltese: Clopidogrel BMS kien iktar effikaċi mill-aspirina fil-prevenzjoni ta' każijiet iskemiċi.
English: Clopidogrel BMS is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Clopidogrel BMS jintuża f'adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis tal-arterji).
English: Why has Clopidogrel BMS been approved?
Maltese: Għaliex ġie approvat Clopidogrel BMS?
English: Clopidogrel BMS has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral arterial disease.
Maltese: Clopidogrel BMS ġie mqabbel ma' aspirina fi studju msejjaħ CAPRIE li inkluda madwar 19,000 pazjent li riċentement sofrew attakk tal-qalb jew puplesija iskemika, jew li mardu fl-arterji periferiċi.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
Maltese: Dan hu segwit minn doża standard ta' 75 mg darba kuljum għal tal-inqas erba' ġimgħat (f'infart mijokardiku ta' elevazzjoni tas-segment ST) jew għal mhux iktar minn 12-il xahar (filpreżenza ta' sindromu mingħajr elevazzjoni tas-segment ST).
English: • patients who have a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots), including patients who have had a stent inserted (a short tube placed in an artery to prevent it closing up).
Maltese: • pazjenti b'kundizzjoni magħrufa bħala ‘sindromu koronarju akut', meta jingħata mal-aspirina (mediċina oħra li tipprevjeni li jagħqad id-demm), fosthom f'pazjenti li tkun iddaħħlitilhom stent (tubu qasir imqiegħed f'arterja biex ma jħallihiex tingħalaq).
English: What is the risk associated with Clopidogrel BMS?
Maltese: X'inhu r-riskju assoċjat ma' Clopidogrel BMS?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Clopidogrel BMS's benefits are greater than its risks in adults for the prevention of atherothrombotic events.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Clopidogrel BMS jisbqu r-riskji tiegħu f'adulti għall-prevenzjoni ta' każijiet aterotrombotiċi.
English: Clopidogrel BMS has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted for up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Clopidogrel BMS with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks.
Maltese: Fis-sindromu koronarju akut, Clopidogrel BMS tqabbel ma' plaċebo (trattament finta) li involva 'l fuq minn 12,000 pazjent b'non-elevazzjoni tat-taqsima ST, b'2,171 minnhom kellhom stent imdaħħal waqt l-istudju (l-istudju CURE, li dam mhux aktar minn sena). Clopidogrel BMS tqabbel ukoll ma' plaċebo f'żewġ studji li involvew pazjenti b'elevazzjoni tat-taqsima ST: CLARITY li involva madwar 3,000 pazjent u dam madwar tmint ijiem; u COMMIT, li involva madwar 46,000 pazjent u li fihom ilpazjenti rċevew Clopidogrel BMS bi jew mingħajr metoprolol (mediċina oħra użata fil-problemi talqalb jew il-pressjoni għolja) għal mhux iktar minn erba' ġimgħat.
English: It is available as pink tablets (round: 75 mg; oblong: 300 mg).
Maltese: Jiġi bħala pilloli roża (tondi: 75
English: For the full list of all side effects reported with Clopidogrel BMS, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati bi Clopidogrel BMS, ara l-Fuljett ta' Tagħrif.
English: Clopidogrel BMS can be used in patients who are having a heart attack with an ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment.
Maltese: Clopidogrel BMS jista' jintuża f'pazjenti li jkollhom attakk tal-qalb flimkien ma' ‘elevazzjoni fit-taqsima ST' (riżultat mhux normali ta' l-elettrokardjogramma jew ECG) meta t-tabib ikun ikkunsidra li jkunu se jibbenefikaw mit-trattament.
English: This showed that Clopidogrel BMS reduces the risk of an event.
Maltese: IlKumitat irrakkomanda li Clopidogrel BMS jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Clopidogrel BMS can be started between a few days and 35 days after the attack;
Maltese: Clopidogrel BMS jista' jinbeda fl-ewwel ftit jiem wara l-attakk u sa 35 ġurnata wara;
English: What benefit has Clopidogrel BMS shown during the studies?
Maltese: Liema benefiċċju wera Clopidogrel BMS waqt l-istudji li twettqu?
English: 2017 Oct;17:75-83.
Maltese: Mult Scler Relat Disord. 2017 Oct;17:75-83.
English: 2016 Apr 29;3(3):e228
Maltese: Neurol Neuroimmunol Neuroinflamm. 2016 Apr 29;3(3):e228
English: 2 Thomas K, Eisele J, Rodriguez-Leal FA, Hainke U, Ziemssen T. Acute effects of alemtuzumab infusion in patients with active relapsing-remitting MS. Neurol Neuroimmunol Neuroinflamm.
Maltese: 2 Thomas K, Eisele J, Rodriguez-Leal FA, Hainke U, Ziemssen T. Acute effects of alemtuzumab infusion in patients with active relapsing-remitting MS.
English: o severe active infections until complete resolution,
Maltese: o b'infezzjonijiet attivi severi sa fejqan sħiħ,
English: Mechanism of first-dose cytokine-release syndrome by CAMPATH 1-H: involvement of CD16 (FcgammaRIII) and CD11a/CD18 (LFA-1) on NK cells.
Maltese: Mechanism of first-dose cytokine-release syndrome by CAMPATH 1-H: involvement of CD16 (FcgammaRIII) and CD11a/CD18 (LFA-1) on NK cells. J Clin Invest 1996;98(12):2819-2826
English: o history of angina pectoris or myocardial infarction,
Maltese: o bi storja ta' angina pectoris jew infart mijokardijaku,
English: o uncontrolled hypertension,
Maltese: o b'ipertensjoni mhux ikkontrollata,
English: Overall summary of the scientific evaluation by the PRAC
Maltese: Sommarju globali tal-valutazzjoni xjentifika mill-PRAC
English: • Lemtrada should also be contraindicated in patients with:
Maltese: • Lemtrada għandu jkun kontraindikat ukoll f'pazjenti:
English: In future PSURs, the MAH is expected to submit cumulative reviews and discuss the following safety concerns: vasculitis, CNS inflammation, GBS, diabetes type 1, myasthenic syndrome, myositis, sarcoidosis, GBS, pneumonitis and EBV hepatitis.
Maltese: Fil-PSURs futuri, l-MAH mistenni li jissottometti rieżamijiet kumulattivi u jiddiskuti t-tħassib li ġej dwar is-sigurtà: vaskulite, infjammazzjoni tas-CNS, GBS, dijabete tat-tip 1, sindrome mijasteniku, mijożite, sarkojdożi, GBS, pulmonite u epatite EBV.
English: Whereas
Maltese: - Każijiet fatali:
English: • PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Lemtrada.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għal Lemtrada.
English: o history of stroke,
Maltese: o bi storja ta' puplesija,
English: - Cardiovascular adverse events in close temporal association with Lemtrada infusions (e.g. cardiac ischaemia and myocardial infarction, ischaemic and haemorrhagic stroke, arterial dissection, pulmonary haemorrhage and embolism, vasculitis and thrombocytopenia), including a possible mechanistic relation to these adverse events.
Maltese: - Avvenimenti avversi kardjovaskulari f'assoċjazzjoni temporali mill-qrib ma' infużjonijiet ta' Lemtrada (eż. iskemija kardijaka u infart mijokardijaku, puplesija iskemika u emorraġika, dissezzjoni arterjali, emorraġija pulmonari u emboliżmu, vaskulite u tromboċitopenija), inkluża l-possibbiltà ta' rabta mekkanikistika ma' dawn l-avvenimenti avversi.
English: During the assessment of the periodic safety update report (PSUSA) for Lemtrada (EMEA/H/C/PSUSA/00010055/201809), the following new emerging and serious safety concerns were highlighted in addition to the known safety profile of alemtuzumab, which raised major concerns to the Pharmacovigilance Risk Assessment Committee (PRAC):
Maltese: Matul il-valutazzjoni tar-rapport perjodiku għall-aġġornament dwar is-sigurtà (PSUSA) għal Lemtrada (EMEA/H/C/PSUSA/00010055/201809), ġie enfasizzat it-tħassib emerġenti u serju ġdid li ġej dwar issigurtà flimkien mal-profil tas-sigurtà magħruf ta' alemtuzumab, li qajjem tħassib kbir għall-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC):
English: Cases of pulmonary embolism, vasculitis, central nervous system autoimmune disease and GuillainBarre Syndrome (GBS) have been reported.
Maltese: Ġew irrapportati każijiet ta' emboliżmu pulmonari, vaskulite, mard awtoimmuni tas-sistema nervuża ċentrali u Sindrome ta' Guillain-Barre (GBS).
English: Acute coronary syndrome and cerebrovascular events including arterial dissection and haemorrhagic stroke, pulmonary haemorrhage and transient thrombocytopenia have been identified as risks in close temporal association with the infusion of alemtuzumab.
Maltese: Sindrome koronarju akut u avvenimenti ċerebrovaskulari inklużi dissezzjoni arterjali u puplesija emorraġika, emorraġija pulmonari u tromboċitopenija temporanja ġew identifikati bħala riskji f'assoċjazzjoni temporali mill-qrib bl-infużjoni ta' alemtuzumab.
English: - Immune-mediated diseases such as auto-immune hepatitis, hepatic injury, auto-immune-mediated central nervous system disease and Guillain-Barre Syndrome (GBS).
Maltese: - Mard medjat mis-sistema immuni bħal epatite awtoimmuni, korriment epatiku, marda tas-sistema nervuża ċentrali medjata mis-sistema awtoimmuni u s-Sindrome ta' Guillain-Barré (GBS).
English: During the procedure, other new adverse reactions were identified which are also considered related to Lemtrada such as Epstein-Barr virus re-activation.
Maltese: Matul il-proċedura, ġew identifikati reazzjonijiet avversi ġodda oħra li huma wkoll ikkunsidrati bħala relatati ma' Lemtrada bħal riattivazzjoni tal-virus Epstein-Barr.
English: Recent studies of RRMS with long-term follow-up have shown that disease-modifying therapies (DMTs) reduce the proportion of patients who progress to SPMS compared to the proportion of untreated patients who progress.
Maltese: Studji reċenti ta' RRMS b'segwitu fit-tul urew li t-terapiji li jimmodifikaw il-marda (DMTs) inaqqsu lproporzjon ta' pazjenti li jipprogressaw għal SPMS meta mqabbla mal-proporzjon ta' pazjenti mhux ittrattati li jagħmlu progress.
English: These risks are considered to be related to cytokine release syndrome, which has been described in the literature for alemtuzumab1,2.
Maltese: Dawn ir-riskji huma kkunsidrati li huma relatati mas-sindromu ta' rilaxx taċ-ċitokina, li ġie deskritt fil-letteratura għal alemtuzumab1,2.
English: Grounds for PRAC recommendation
Maltese: Konklużjonijiet xjentifiċi
English: • PRAC concluded that myocardial ischaemia, myocardial infarction, haemorrhagic stroke, dissection of the cervicocephalic arteries, pulmonary alveolar haemorrhage and thrombocytopenia may occur in close temporal association with the infusion of Lemtrada.
Maltese: • Il-PRAC ikkonkluda li iskemija mijokardijaka, infart mijokardijaku, puplesija emorraġika, dissezzjoni tal-arterji ċervikoċefaliċi, emorraġija alveolari pulmonari u tromboċitopenija jistgħu jseħħu f'assoċjazzjoni temporali mill-qrib mal-infużjoni ta' Lemtrada.
English: Therefore many of the newly-identified risks associated to Lemtrada are unpredictable and largely unavoidable.
Maltese: Għalhekk ħafna mir-riskji li għadhom kif ġew identifikati assoċjati ma' Lemtrada huma imprevedibbli u ġeneralment inevitabbli.
English: o coagulopathy, on antiplatelet or anti-coagulant therapy o concomitant autoimmune diseases other than multiple sclerosis.
Maltese: o b'koagulapatija, fuq terapija kontra l-pjastrini jew antikoagulanti o b'mard awtoimmuni konkomitanti minbarra l-isklerożi multipla.
English: • As a consequence, PRAC recommended that treatment with Lemtrada should be restricted to patients with highly active relapsing remitting multiple sclerosis for the following patient groups:
Maltese: • B'konsegwenza ta' dan, il-PRAC irrakkomanda li t-trattament b'Lemtrada għandu jkun ristrett għal pazjenti bi sklerożi multipla li tirkadi-tbatti attiva ħafna għall-gruppi ta' pazjenti li ġejjin:
English: • PRAC reviewed data currently available from post-marketing setting and from clinical trials on fatal cases, cardiovascular adverse events in close temporal association with Lemtrada infusions and immune-mediated diseases, including data provided in writing and at an oral explanation.
Maltese: • Il-PRAC irrieżamina d-data disponibbli attwalment mill-ambjent ta' wara t-tqegħid fis-suq u minn provi kliniċi fuq każijiet fatali, avvenimenti avversi kardjovaskolari f'assoċjazzjoni temporali mill-qrib ma' infużjonijiet ta' Lemtrada u mard immedjat mis-sistema immuni, inkluża data pprovduta bil-miktub u bi spjegazzjoni bil-fomm.
English: Vulnerable patient groups such as patients with severe active infections until complete resolution, uncontrolled hypertension, a history of arterial dissection of the cervicocephalic arteries, of stroke, angina pectoris or myocardial infarction and patients with known coagulopathy, on anti-platelet or anticoagulant therapy, should be contraindicated.
Maltese: Gruppi ta' pazjenti vulnerabbli bħal pazjenti b'infezzjonijiet attivi severi sakemm iseħħ fejqan sħiħ, ipertensjoni mhux ikkontrollata, storja ta' dissezzjoni arterjali tal-arterji ċervikoċefaliċi, ta' puplesija, angina pectoris jew infart mijokardijaku u pazjenti b'koagulopatija magħrufa, fuq terapija kontra l-pjastrini
English: One general characteristic of alemtuzumab which impacts on its safety profile and on risk management is the very long treatment effect, and thereby the infrequent administration regimen.
Maltese: Karatteristika ġenerali ta' alemtuzumab li għandha impatt fuq il-profil tas-sigurtà tiegħu u fuq ilġestjoni tar-riskju huwa l-effett twil ħafna tat-trattament, u b'hekk il-kors tal-għoti mhux frekwenti.
English: On 10 April 2019 the European Commission (EC) therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data and requested the PRAC to assess the above safety concerns and their impact on the benefit-risk balance of Lemtrada and to issue a recommendation on whether the relevant marketing authorisation should be maintained, varied, suspended or revoked.
Maltese: Għalhekk, fl-10 ta' April 2019, il-Kummissjoni Ewropea (KE) tat bidu għal proċedura skont l-Artikolu 20 tar-Regolament(KE) Nru 726/2004 bħala riżultat tad-data dwar il-farmakoviġilanza u talbet lill-PRAC jivvaluta t-tħassib dwar is-sigurtà ta' hawn fuq u l-impatt tiegħu fuq il-bilanċ bejn il-benefiċċju u rriskju ta' Lemtrada u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjoni għat-tqegħid fis-suq rilevanti għandhiex tinżamm, tiġu varjata, sospiża jew revokata.
English: There are uncertainties about a potential causal relationship with a number of other autoimmune adverse events reported in temporal association with Lemtrada, and these will have to continue to be closely monitored in the future.
Maltese: Hemm inċertezzi dwar relazzjoni kawżali potenzjali ma' għadd ta' avvenimenti avversi awtoimmuni oħrajn irrappurtati f'assoċjazzjoni temporali ma' Lemtrada, u dawn se jkollhom ikomplu jiġu mmonitorjati mill-qrib fil-futur.
English: Following the review, it has been reconfirmed that Lemtrada causes secondary autoimmune disease including auto-immune hepatitis, thyroiditis, immune thrombocytopenic purpura, acquired haemophilia A, nephropathies, cytopenias and serious immunological reactions such as haemophagocytic lymphohistiocytosis.
Maltese: Wara r-rieżami, ġie kkonfermat mill-ġdid li Lemtrada jikkawża mard awtoimmuni sekondarju inklużi epatite awtoimmuni, tirojdite, purpura tromboċitopenika immuni, emofilja A akkwiżita, nefropatiji, ċitopenji, u reazzjonijiet immunoloġiċi serji bħal limfoistjoċitożi emofagoċitika.
English: o patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy, or o patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Maltese: o pazjenti b'mard attiv ħafna minkejja kors ta' trattament sħiħ u adegwat b'minn talinqas terapija waħda li timmodifika l-marda, jew o pazjenti bi sklerożi multipla li tirkadi-tbatti severa li qed tevolvi b'mod rapidu, li hija definita minn żewġ rikaduti jew aktar ta' diżabilità f'sena, u b'leżjoni waħda jew aktar ta' żieda fil-Gadolinium f'MRI tal-moħħ jew żieda sinifikanti fit-tagħbija tal-leżjoni T2 meta mqabbla ma' MRI riċenti preċedenti.