FrancophonIA/ELRC3.0 huggingface dataset:
English: Information on the cardiovascular safety and well-documented blood system adverse reactions, which may contribute to the cardiovascular risk should be included in the product information.
Maltese: Informazzjoni dwar is-sigurtà kardjovaskolari u reazzjonijiet avversi tas-sistema tad-demm iddokumentati sew, li jistgħu jikkontribwixxu għar-riskju kardjovaskolari għandha tiġi inkluża fl-informazzjoni tal-prodott.
English: knowledge to date, the PRAC recommended that the possible mechanism on the association between cardiovascular/venous thromboembolic events and the level of testosterone be further investigated by the marketing authorisation holders and reported at the next PSUR.
Maltese: Bħala konsegwenza ta' dan, il-PRAC ikkonkluda li l-bilanċ benefiċċju-riskju ta' prodotti mediċinali li fihom it-testosteron jibqa' favorevoli soġġett għall-kundizzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq, u b'kunsiderazzjoni għall-emendi rrakkomandati fl-informazzjoni tal-prodott.
English: The PRAC noted that others studies will become available.
Maltese: Il-PRAC innota li studji oħra sejrin isiru disponibbli.
English: Testosterone, as well as other androgens and anabolic steroids, should be used cautiously in patients with cardiovascular disorders, renal or hepatic impairment, epilepsy, migraine, diabetes mellitus or other conditions that may be aggravated by the possible fluid retention or oedema caused.
Maltese: It-testosteron, kif ukoll androġeni u sterojdi anaboliċi oħrajn, għandhom jintużaw b'attenzjoni f'pazjenti b'disturbi gastorvaskolari, indeboliment renali jew epatiku, epilessija, emigranja, dijabete mellitus jew kundizzjonijiet oħrajn li jistgħu jiggravaw biż-żamma ta' fluwidi jew edema li jistgħu jiġu kkawżati.
English: EMA/299803/2011 EMEA/V/C/000161
Maltese: EMEA/V/C/000161
English: This summary was last updated in March 2016
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Marzu 2016.
English: The full EPAR for MS-H Vaccine can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Mycoplasma synoviae strain MS-H vaccine (live attenuated)
Maltese: It-tip Mycoplasma synoviae tal-vaċċin MS-H (imdgħajjef)
English: This is a summary of the European public assessment report (EPAR) for MS-H Vaccine.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għall- MS-H Vaccine.
English: The company presented data from laboratory studies and from one field trial.
Maltese: Il-kumpanija ppreżentat data minn studji fil-laboratorju u minn prova waħda fuq il-post.
English: Protection against damage to air sacs lasts for 40 weeks, but the duration of protection against abnormal shells forming is not known.
Maltese: Il-protezzjoni kontra l-ħsara fil-boroż talarja ddum 40 ġimgħa, iżda t-tul tal-protezzjoni mill-formazzjoni ta' qxur anormali mhix magħrufa.
English: The person administering the vaccine should wear protective equipment, consisting of gloves and safety glasses to avoid skin and eye injuries which may occur by manipulating the vaccine bottle which is frozen.
Maltese: Il-persuna li tamministra l-vaċċin għandha tilbes tagħmir protettiv, li jikkonsisti minn ingwanti u nuċċalijiet ta' sigurtà biex ikunu evitati ħsarat fil-ġilda jew fl-għajnejn li jistgħu jokkorru waqt ilmanipulazzjoni tal-flixkun tal-vaċċin li jkun friżat.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for MS-H vaccine on 14 June 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal MS-H Vaccine valida fl-Unjoni Ewropea kollha fl-14 ta' Ġunju 2011.
English: MS-H Vaccine is a vaccine used in chickens from five weeks of age to protect them against Mycoplasma synoviae.
Maltese: MS-H Vaccine huwa vaċċin u jintuża fit-tiġieġ minn età ta' ħames ġimgħat biex jipproteġihom kontra lMycoplasma synoviae.
English: Why is MS-H Vaccine approved?
Maltese: Għaliex ġie approvat MS-H Vaccine?
English: MS-H Vaccine, like all vaccines, works by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: MS-H Vaccine, bħall-vaċċini kollha, jaħdem billi ‘jgħallem' lis-sistema immunitarja (id-difiżi naturali talġisem) kif tiddefendi ruħha kontra marda.
English: In the future, if the animals are exposed to Mycoplasma synoviae, the immune system will be able to respond more quickly.
Maltese: Fil-futur, jekk l-annimali jiġu esposti għal Mycoplasma synoviae, is-sistema immunitarja tkun kapaċi tirrispondi b'mod aktar mgħaġġel.
English: MS-H Vaccine is used in young chickens intended to produce eggs for broilers (for meat) and layers (for egg production) to reduce the damage to air sacs and reduce the number of eggs with abnormal shells.
Maltese: MS-H Vaccine jintuża fit-tiġieġ żgħar imrobbija biex jipproduċu l-bajd għall-brojlers (għal-laħam) u għal dawk li jipproduċu l-bajd (għall-produzzjoni tal-bajd) biex inaqqas il-ħsara lill-boroż tal-arja u jnaqqas in-numru ta' bajd bi qxur anormali.
English: Infection with Mycoplasma synoviae may result in difficulty breathing and is also associated with poor quality of the eggshell.
Maltese: Infezzjoni b'Mycoplasma synoviae tista' twassal għal diffikulta fit-teħid tan-nifs u hija wkoll assoċjata ma' kwalità dgħajfa tal-qoxra tal-bajda.
English: The vaccine has no known side effects.
Maltese: Il-vaċċin ma għandux effetti sekondarji magħrufa.
English: What are the risks associated with MS-H Vaccine?
Maltese: X'riskji huma assoċjati ma' MS-H Vaccine?
English: The field study looked at how vaccinated chickens fared when moved to flocks with a history of Mycoplasma synoviae infection.
Maltese: L-istudju fuq il-post ħares lejn kif marru t-tiġieġ imlaqqma meta tpoġġew ma' qatgħat bi storja ta' infezzjoni bi Mycoplasma synoviae.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that MS-H Vaccine's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' MS-H Vaccine huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: How does MS-H Vaccine work?
Maltese: Kif jintuża dan MS-H Vaccine?
English: The laboratory studies showed that MS-H Vaccine reduces damage to the air sacs and reduces the number of eggs with shell abnormalities.
Maltese: L-istudji fil-laboratorju wrew li MS-H Vaccine jnaqqas il-ħsara lill-boroż tal-arja u jnaqqas in-numru ta' bajd b'anormalitajiet fil-qxur.
English: Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/114)
Maltese: Riżultat ta' proċedura skont l-Artikolu 34 tad-Direttiva 2001/82/KE (EMEA/V/A/114)
English: Denagard 45% (and associated names such as Tiamutin 45%, Denagard 450 mg/g and Denagard vet 450 mg/g) is marketed in Austria, Belgium, Czech Republic, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Slovak Republic and Spain.
Maltese: Denagard 45 % (u ismijiet assoċjati bħal Tiamutin 45 %, Denagard 450 mg/g u Denagard vet 450 mg/g) jitqiegħed fis-suq fl-Awstrija, fil-Belġju, fir-Repubblika Ċeka, fil-Finlandja, fil-Ġermanja, filGreċja, fl-Ungerija, fl-Italja, fil-Latvja, fil-Litwanja, fin-Netherlands, fil-Polonja, fil-Portugall, firRumanija, fir-Repubblika Slovakka u fi Spanja.
English: Denagard 45% is authorised in the EU via national procedures.
Maltese: Denagard 45 % huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: Denagard 45% is a veterinary medicinal product available as granules for use in drinking water and contains 450 mg tiamulin hydrogen fumarate per gram product.
Maltese: Denagard 45 % huwa prodott mediċinali veterinarju li jiġi bħala granuli għall-użu fl-ilma tax-xorb u li fih 450 mg tiamulin hydrogen fumarate għal kull gramma ta' prodott.
English: The amended product information is available on the 'All documents' tab.
Maltese: L-informazzjoni dwar il-prodott emendata hija disponibbli fit-tab “Id-dokumenti kollha” (“All documents”).
English: Denagard 45% is indicated for the treatment of swine dysentery, colitis, ileitis, enzootic pneumonia and pleuropneumonia in pigs; chronic respiratory disease in chickens and infectious sinusitis and airsacculitis in turkeys.
Maltese: Denagard 45 % huwa indikat għall-kura ta' diżenterija tal-majjali, kolite, ileite, pulmonite enżootika u plewropulmonite fil-ħnieżer; mard respiratorju kroniku fit-tiġieġ u sinusite u sakkulite tal-arja infettivi fid-dundjani.
English: On 12 April 2017, the European Medicines Agency (the Agency) completed a review of Denagard 45%.
Maltese: Fit-12 ta' April 2017, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet reviżjoni ta' Denagard 45 %.
English: What is Denagard 45%?
Maltese: Għaliex ġie rieżaminat Denagard 45 %?
English: Tiamulin is a semi-synthetic antibiotic belonging to the pleuromutilin group of antibiotics and works by inhibiting bacterial protein synthesis.
Maltese: Tiamulin huwa antibijotiku semisintetiku li jappartjeni għall-grupp ta' antibijotiċi pleuromutilin u jaħdem billi jinibixxi s-sinteżi talproteini batteriċi.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information (summary of product characteristics (SPC), labelling and package leaflet) for Denagard 45% in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CHMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni dwar il-prodott (sommarju tal-karatteristiċi talprodott (SPC), tat-tikkettar u tal-fuljett ta' tagħrif), għal Denagard 45 % fl-Unjoni Ewropea (UE).
English: Questions and answers on Denagard 45% and its associated names EMA/275123/2017
Maltese: 14 ta' Lulju 2017 EMA/491896/2017
English: On 24 August 2016, Germany referred the matter to the CVMP in order to harmonise the product information for Denagard 45% (and associated names) in the EU.
Maltese: Fl-24 ta' Awwissu 2016, il-Ġermanja rreferiet il-kwistjoni lis-CHMP sabiex jarmonizza l-informazzjoni dwar il-prodott għal Denagard 45 % (u ismijiet assoċjati) fl-UE.
English: Based on the evaluation of the currently-available data, the CVMP concluded that the product information for Denagard 45% and its associated names should be harmonised across the EU.
Maltese: Abbażi tal-valutazzjoni tad-dejta disponibbli bħalissa, is-CVMP ikkonkluda li l-informazzjoni dwar ilprodott għal Denagard 45 % u ismijiet assoċjati tiegħu għandha tiġi armonizzata fl-UE.
English: Zinbryta (daclizumab) is a centrally authorised medicinal product indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (RMS).
Maltese: Zinbryta (daclizumab) huwa prodott mediċinali awtorizzat b'mod ċentrali indikat f'pazjenti adulti għallkura ta' forom rikaduti ta' sklerożi multipla (RMS, relapsing forms of multiple sclerosis).
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, in particular regarding the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004 for Zinbryta (daclizumab).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat ta' data dwar il-farmakoviġilanza, b'mod partikolari rigward il-ħtieġa għal miżuri proviżorji skont l-Artikolu 20(3) tar-Regolament (KE) Nru 726/2004 għal Zinbryta (daclizumab).
English: Transaminases elevations and serious hepatic injury are known risks associated to treatment with Zinbryta (daclizumab) and several risk minimisation measures (RMMs) were implemented in this regard, including monthly liver function monitoring.
Maltese: Żidiet fit-transaminases u ħsara serja fil-fwied huma riskji magħrufa assoċjati mal-kura b'Zinbryta (daclizumab) u f'dan ir-rigward ġew implimentati diversi miżuri tal-minimizzazzjoni tar-riskju (RMMs, risk minimisation measures), inkluż monitoraġġ kull xahar tal-funzjoni tal-fwied.
English: However, a number of serious hepatic events in patients in daclizumab groups occurred in the setting of concomitant drugs with known hepatotoxic potential, including one fatal autoimmune hepatitis and one non-fatal hepatic failure assessed by an adjudication committee as probable Hy's Law (indicative of a risk of drug-induced severe liver injury).
Maltese: Madankollu, kien hemm numru ta' avvenimenti fil-fwied serji f'pazjenti fil-gruppi ta' daclizumab fl-ambjent ta' mediċini konkomitanti b'potenzjal epatotossiku magħruf, inkluż epatite awtoimmunitarja fatali waħda u insuffiċjenza tal-fwied mhux fatali waħda vvalutati minn kumitat ta' aġġudikazzjoni bħala Liġi ta' Hy probabbli (indikattiva ta' riskju ta' ħsara fil-fwied severa indotta mill-mediċina).
English: The current recommendation relates only to provisional measures recommended by the PRAC for daclizumab based on the preliminary data available at this time.
Maltese: Ir-rakkomandazzjoni attwali hija relatata biss ma' miżuri proviżorji rakkomandati mill-PRAC għal daclizumab abbażi tad-data preliminarja disponibbli bħalissa.
English: On 9 June 2017 the 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 impact of the above concerns on the benefit-risk balance of Zinbryta (daclizumab) and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Għalhekk fid-9 ta' Ġunju 2017, il-KE tat bidu għal proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat ta' data dwar il-farmakoviġilanza, u talbet lill-PRAC jevalwa l-impatt tattħassib imsemmi hawn fuq dwar il-bilanċ bejn il-benefiċċju u r-riskju ta' Zinbryta (daclizumab) u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq rilevanti għandhomx jinżammu, jiġu varjati, sospiżi jew revokati.
English: During the clinical development, transaminases elevations and serious hepatic injury were identified as important identified risks.
Maltese: Matul l-iżvilupp kliniku, żidiet fittransaminases u ħsara serja fil-fwied ġew identifikati bħala riskji identifikati importanti.
English: • The PRAC noted that a fatal case of fulminant liver failure occurred despite adherence to the terms of the marketing authorisation and the risk minimisation measures recommended, including the liver function monitoring.
Maltese: • Il-PRAC innota li seħħ każ fatali ta' insuffiċjenza tal-fwied fulminanti minkejja l-aderenza għattermini tal-awtorizzazzjoni għat-tqegħid fis-suq u l-miżuri tal-minimizzazzjoni tar-riskju rakkomandati, inkluż il-monitoraġġ tal-funzjoni tal-fwied.
English: The above provisional measures should be reflected in the product information of daclizumab and communicated to HCPs via a dedicated letter.
Maltese: Il-miżuri proviżorji ta' hawn fuq għandhom jiġu riflessi fl-informazzjoni dwar il-prodott ta' daclizumab u jiġu kkomunikati lill-HCPs permezz ta' ittra dedikata.
English: Considering the lack of clinical data in patients with pre-existent significant hepatic diseases as these were excluded from clinical trials, the new serious hepatic cases, and that a mild elevation of serum transaminases was reported prior to treatment initiation in the patient who died of fulminant liver failure, the PRAC recommended as a provisional measure that daclizumab should be contraindicated in all patients with pre-existing hepatic disease or hepatic impairment, while the pattern of hepatotoxicity and possible mechanism of action is further investigated.
Maltese: Meta jiġi kkunsidrat in-nuqqas ta' data klinika f'pazjenti b'mard tal-fwied sinifikanti preeżistenti peress li dawn ġew esklużi mill-provi kliniċi, il-każijiet tal-fwied serji ġodda, u li ġiet irrappuratata żieda ħafifa ta' transaminases fis-serum qabel il-bidu tal-kura fil-pazjent li miet b'insuffiċjenza tal-fwied fulminanti, ilPRAC irrakkomanda bħala miżura proviżorja li daclizumab għandu jiġi kontraindikat fil-pazjenti kollha b'marda tal-fwied jew b'indeboliment tal-fwied preeżistenti, waqt li t-tendenza tal-epatotossiċità u lmekkaniżmu ta' azzjoni possibbli jkomplu jiġu investigati.
English: Thus, considering the serious risk of hepatic injury along with the benefit that daclizumab may bring to RMS patients, the PRAC recommended that the use of daclizumab should be provisionally restricted to adult patients with highly active RMS despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) or, with rapidly evolving severe relapsing multiple sclerosis who are unsuitable for treatment with other DMTs.
Maltese: Għalhekk, meta jiġi kkunsidrat ir-riskju serju ta' ħsara fil-fwied flimkien mal-benefiċċju li daclizumab jista' jġib għal pazjenti ta' RMS, il-PRAC irrakkomanda li l-użu ta' daclizumab għandu jiġi ristrett b'mod proviżorju għal pazjenti adulti b'RMS attiva ħafna minkejja kors sħiħ u adegwat ta' kura b'tal-inqas terapija li timmodifika l-marda (DMT, disease modifying therapy) waħda jew, bi sklerożi multipla rikaduta severa li tevolvi b'mod rapidu li mhumiex xierqa għal kura b'DMTs oħra.
English: Therefore, while the magnitude and nature of the risk are being reviewed in depth, having considered the seriousness of the risk and that further RMMs that would be effective in preventing with certainty any new severe cases cannot be identified at this stage, the PRAC considered that it is necessary to provisionally limit the use of daclizumab through restriction of the indication and through preventing its use in patients potentially predisposed to liver injury and provide further recommendations to healthcare professionals (HCPs) and patients in the management of this risk.
Maltese: Għalhekk, waqt li d-daqs u n-natura tar-riskju qed jiġu reveduti fil-fond, wara li ġiet ikkunsidrata s-serjetà tar-riskju u li f'dan l-listadju ma jistax jiġi identifikat jekk aktar RMMs ikunux effettivi biex b'ċertezza jipprevjenu xi każijiet severi ġodda, il-PRAC ikkunsidra li huwa neċessarju li jillimita b'mod proviżorju l-użu ta' daclizumab permezz tar-restrizzjoni talindikazzjoni u permezz tal-prevenzjoni tal-użu tiegħu f'pazjenti predisposti potenzjalment għal ħsara fil-fwied u li jipprovdi aktar rakkomandazzjonijiet lill-professjonisti fil-qasam tal-kura tas-saħħa (HCPs) u lill-pazjenti fil-ġestjoni ta' dan ir-riskju.
English: • The PRAC recommended as provisional measure amendment to the indication of daclizumab to restrict its use to adult patients with highly active relapsing disease despite a previous treatment with at least one disease modifying therapy (DMT) or, with rapidly evolving severe relapsing multiple sclerosis who are unsuitable for treatment with other DMTs.
Maltese: • Bħala miżura proviżorja, il-PRAC irrakkomanda emenda għall-indikazzjoni ta' daclizumab sabiex jiġi limitat l-użu tiegħu għal pazjenti adulti b'marda rikaduta attiva ħafna minkejja kura preċedenti b'tal-inqas terapija li timmodifika l-marda (DMT) waħda jew, bi sklerożi multipla rikaduta severa li tevolvi b'mod rapidu li mhumiex xierqa għal kura b'DMTs oħra.
English: The majority of findings were asymptomatic transaminases elevations, however a low incidence of serious liver events and a rare incidence of fatal liver failure (autoimmune hepatitis) were acknowledged as important risks with daclizumab.
Maltese: Il-maġġoranza tas-sejbiet kienu żidiet fit-transaminases asintomatiċi, madankollu, inċidenza baxxa ta' avvenimenti serji fil-fwied u inċidenza rari ta' insuffiċjenza tal-fwied fatali (epatite awtoimmunitarja) ġew rikonoxxuti bħala riskji importanti b'daclizumab.
English: • The PRAC reviewed the preliminary data provided by the marketing authorisation holder on cases of serious liver injury reported since the initial marketing authorisation, in the context of available safety data from clinical trials submitted in support of the initial marketing authorisation in relation to the overall risk of liver injury with daclizumab.
Maltese: • Il-PRAC irrieżamina d-data preliminarja pprovduta mid-detentur tal-awtorizzazzjoni għattqegħid fis-suq dwar każijiet ta' ħsara serja fil-fwied irrappurtati sa mill-awtorizzazzjoni għattqegħid fis-suq inizjali, fil-kuntest ta' data dwar is-sigurtà disponibbli mill-provi kliniċi ppreżentata biex tappoġġa l-awtorizzazzjoni għat-tqegħid fis-suq inizjali fir-rigward tar-riskju globali ta' ħsara fil-fwied b'daclizumab.
English: • In addition, the PRAC recommended, as provisional measures to further minimise the risk of liver injury, to strengthen the current warnings to take due account that all patients should be monitored for signs and symptoms of hepatic injury and that liver functions testing should be performed at least monthly, to promptly refer patients to an hepatologist in case of signs or symptoms suggestive of such injury and that treatment initiation is not recommended in patients with other autoimmune conditions.
Maltese: • Barra minn hekk, bħala miżuri proviżorji sabiex ikompli jiġi minimizzat ir-riskju ta' ħsara filfwied, il-PRAC irrakkomanda li jissaħħu t-twissijiet attwali sabiex jikkunsidraw li l-pazjenti kollha għandhom jiġu mmonitorjati għal sinjali u sintomi ta' ħsara fil-fwied u li għandu jsir ittestjar tal-funzjonijiet tal-fwied tal-inqas kull xahar, sabiex jirreferu lill-pazjenti minnufih għand epatoloġista f'każ ta' sinjali jew sintomi li jissuġġerixxu tali ħsara u li l-bidu tal-kura mhuwiex rakkomandat f'pazjenti b'kondizzjonijiet awtoimmunitarji oħra.
English: Analyses performed in the clinical development program to assess potential interactions of daclizumab with potentially hepatotoxic medications showed no clear evidence of increased risk of liver injury with concomitant hepatotoxic medications.
Maltese: Analiżijiet li saru fil-programm ta' żvilupp kliniku sabiex jiġu vvalutati l-interazzjonijiet potenzjali ta' daclizumab ma' medikazzjonijiet potenzjalment epatotossiċi ma wrew l-ebda evidenza ċara ta' riskju miżjud ta' ħsara fil-fwied b'medikazzjonijiet epatotossiċi konkomitanti.
English: On 7 June 2017, the European Commission (EC) was informed of a fatal case of fulminant liver failure in a patient treated with daclizumab in an ongoing observational study, despite monthly liver function testing performed in accordance with recommendations in the product information.
Maltese: Fis-7 ta' Ġunju 2017, il-Kummissjoni Ewropea (KE) ġiet infurmata b'każ fatali ta' insuffiċjenza tal-fwied fulminanti f'pazjent ikkurat b'daclizumab fi studju ta' osservazzjoni li għadu għaddej, minkejja li sar ittestjar kull xahar tal-funzjoni tal-fwied skont ir-rakkomandazzjonijiet fl-informazzjoni dwar il-prodott.
English: HCPs and patients should be informed of the post-marketing fatal case of fulminant liver failure, the common risk of hepatitis and the updated frequency of serious cases of hepatic injury in the light of the new cases.
Maltese: L-HCPs u l-pazjenti għandhom jiġu infurmati dwar il-każ fatali ta' wara t-tqegħid fis-suq ta' insuffiċjenza tal-fwied fulminanti, ir-riskju komuni tal-epatite u l-frekwenza aġġornata ta' każijiet serji ta' ħsara fil-fwied fid-dawl tal-każijiet ġodda.
English: The PRAC took under consideration the alternative treatment options for the different stages or manifestations of RMS and that limiting access to daclizumab may deny some patients a treatment option for this disease.
Maltese: Il-PRAC ikkunsidra l-għażliet ta' kura alternattivi għall-istadji differenti jew manifestazzjonijiet ta' RMS u li l-limitu tal-aċċess għal daclizumab jista' jċaħħad xi pazjenti minn għażla ta' kura għal din il-marda.