FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common); abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems).
Maltese: Infezzjonijiet serji (li jinkludu pnewmonja, infezzjonijiet profondi tal-ġilda, infezzjonijiet tal ġogi, infezzjoni tad-demm, u infezzjonijiet f'siti differenti); iggravar ta' insuffiċjenza konġestiva tal-qalb, għadd baxx taċ-ċelluli bojod tad-demm, għadd baxx ta' newtrofili (tip ta'
English: Pyrexia
Maltese: Frekwenza
English: The known side effects of Erelzi include the following in groups of decreasing frequency:
Maltese: L-effetti sekondarji magħrufa ta' Erelzi jinkludu dawn li ġejjin fi gruppi ta' frekwenza li tonqos:
English: Autoantibody formation Treatment with Erelzi may result in the formation of autoimmune antibodies (see section 4.8).
Maltese: Il-kura b'Erelzi tista' tirriżulta fil-formazzjoni ta' antikorpi awtoimmunitarji (ara sezzjoni 4.8).
English: depression/personality disorder, cutaneous ulcer, oesophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection.
Maltese: gastroenterite, epatite B, herpes zoster, ulċera fir-riġlejn, infezzjoni fil-ħalq, osteomajelite, otitis,
English: Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA)
Maltese: Qabel il-bidu tal-kura b'Erelzi, il-pazjenti kollha jridu jkunu evalwati kemm għal tuberkulosi attiva kif ukoll inattiva (‘moħbija').
English: • Check the green indicator fills the window and has stopped moving.
Maltese: • Iċċekkja li l-indikatur l-aħdar mela t-tieqa u waqaf jiċċaqlaq.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI)ATTIVA/I
English: In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia).
Maltese: Fil-provi double-blind u open-label fuq pazjenti b'artrite psorjatika,
English: The possibility exists for TNF-antagonists, including Erelzi, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Maltese: Teżisti l-possibbiltà għal antagonisti ta' TNF, inkluż Erelzi, li jaffettwaw id-difiża tal-bniedem kontra infjammazzjonijiet u tumuri malinni, peress li t-TNF jimmedja l-infjammazzjoni u jimmodula rispons immunitarju taċ-ċelluli.
English: These instructions are to help you to inject correctly using the Erelzi SensoReady pen.
Maltese: “Istruzzjonijiet għall-użu tal-pinna SensoReady ta' Erelzi”.
English: Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.
Maltese: Il-kura ta' artrite psorjatika attiva u progressiva f'adulti meta r-rispons ma kienx adegwat meta ngħataw terapija b'mediċini anti-rewmatiċi li jimmodifikaw il-marda.
English: In long-term (up to 34 months) open-label studies where etanercept was given without interruption, clinical responses were sustained and safety was comparable to shorter-term studies.
Maltese: Fi studji open-label fit-tul (li damu sa 34 xahar) fejn etanercept ingħata mingħajr interruzzjoni, ir risponsi kliniċi kienu sostnuti u s-sigurtà kienet komparabbli ma' dik fi studji li damu inqas żmien.
English: After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the Erelzi solution in the syringe to reach room temperature.
Maltese: Oħroġ il-folja mill-friġġ u ħalliha toqgħod magħluqa għal madwar 15-30 minuta sakemm tilħaq it-temperatura tal-kamra.
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi SensoReady pen".
Maltese: Istruzzjonijiet komprensivi għall-għoti jingħataw fil-fuljett ta' tagħrif, sezzjoni 7, “Istruzzjonijiet għall-użu tal-pinna Erelzi SensoReady”.
English: In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of interstitial lung disease in patients receiving etanercept without concomitant methotrexate was 0.06% (frequency rare).
Maltese: inċidenza) ta' mard interstizjali tal-pulmun f'pazjenti li kienu qed jirċievu etanercept mingħajr methotrexate konkomitanti kienet ta' 0.06 % (frekwenza rari).
English: Erelzi is only available as 25 mg pre-filled syringe and 50 mg pre-filled syringe and pre-filled pen.
Maltese: Popolazzjoni pedjatrika Erelzi huwa disponibbli bħala 25 mg siringa mimlija għal-lest u 50 mg siringa mimlija għal-lest u pinna mimlija għal-lest.
English: Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Maltese: Kura ta' poliartrite (fattur rewmatojde pożittiv jew negattiv) u oligoartrite estiża fit-tfal u adolexxenti mill-età ta' sentejn li kellhom rispons mhux adegwat għal, jew li ntwera li ma jittollerawx,
English: In part 1 of the study, 51 of 69 (74%) patients demonstrated a clinical response and entered part 2.
Maltese: Fl-ewwel parti tal-istudju, 51 minn 69 (74%) tal-pazjenti wrew rispons kliniku u daħlu għat-tieni parti tal-istudju.
English: Pruritus, rash Angioedema, psoriasis (including new onset or worsening and pustular, primarily palms and soles), urticaria, psoriasiform rash
Maltese: Prurite, raxx Anġjoedema, psorjasi (li tinkludi bidu mill-ġdid jew aggravament ta' psorjasi, u psorjasi bilponot, primarjament filkeffa tal-id u filqiegħ tas-saqajn), urtikarja, raxx psorjasiformi
English: 24a wk 12 wk 12 wk 12 wk 12 wk 12 wk 24a
Maltese: Jekk Erelzi ma jkollux effett fuq il-kundizzjoni tiegħek wara 12il ġimgħa, it-tabib tiegħek għandu mnejn jgħidlek tieqaf tuża din il-mediċina.
English: The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p < 0.001).
Maltese: Il-punteġġ tal-indiċi taddiżabilità kien b'mod sinifikanti aħjar f'kull punt ta' żmien f'pazjenti bl-artrite psorjatika kkurati b'etanercept, meta mqabbel mal-plaċebo (p< 0.001).
English: Clear type I glass syringe with a stainless steel 27 gauge ½ inch needle with a needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.5 ml or 1.0 ml of solution.
Maltese: Siringa ta' ħġieġ ċar ta' tip 1 b'labra ta' ½ pulzier b'kejl ta' 27 ta' azzar li ma jsaddadx, bi protezzjoni tal-labra b'xifer fejn tpoġġi subgħajk, għatu tal-labra tal-lastku u planġer tal-plastik, li jkun fiha 0.5 mL jew 1.0 mL ta' soluzzjoni.
English: A new and unused Erelzi SensoReady pen.
Maltese: Dan jinkludi xi effett sekondarju li mhuwiex elenkat f'dan il-fuljett.
English: The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Maltese: Etanercept jista' wkoll jimmodula r-risponsi bijoloġiċi kkontrollati b'molekuli addizzjonali downstream (eż. cytokines, molekuli tal-adeżjoni jew proteinases) li huma kkaġunati jew irregolati mit-TNF.
English: Mean (SE) annualized change from baseline in total sharp score
Maltese: Bażi b'Punteġġ Totali Sharp
English: Instructions for use and handling of the Erelzi pre-filled SensoReady pen Before injection, Erelzi single-use pre-filled pens should be allowed to reach room temperature (approximately 15 to 30 minutes).
Maltese: Wara li toħroġ is-siringa mill-friġġ, stenna madwar 15-30 minuta biex tippermetti li s-soluzzjoni ta' Erelzi fis-siringa tilħaq it-temperatura tal-kamra.
English: Based on the review of the literature and spontaneous reporting presented in this PSUSA, covering the period from 15 July 2018 to 14 January 2019, as well as cumulative data since the European birth date, the PRAC considered that a causal relationship between inflammatory bowel disease and etanercept cannot be excluded and therefore recommends that the product information of medicinal products containing the active substance etanercept should be updated as follows: update of section 4.8 of the SmPC to add inflammatory bowel disease with a frequency uncommon.
Maltese: Abbażi tar-reviżjoni tal-letteratura u r-rappurtaġġ spontanju fil-PSUSA, li jkopri l-perjodu mill15 ta' Lulju 2018 sal-14 ta' Jannar 2019, kif ukoll id-dejta kumulattiva mid-data tat-twelid Ewropea, il-PRAC (Pharmacovigilance Risk Assessment Committee - il-Kumitat tal-Evalwazzjoni tar-Riskju fil-qasam tal-Farmakoviġilanza) ikkunsidra li relazzjoni kawżali bejn il-mard infjammatorju talimsaren u etanercept ma tistax tiġi eskluża u għalhekk jirrakkomanda li l-informazzjoni tal-prodott ta' prodotti mediċinali li fihom is-sustanza attiva etanercept għandha tiġi aġġornata kif ġej: aġġornament tas-sezzjoni 4.8 tal-SmPC biex iżżid il-mard infjammatorju tal-imsaren bi frekwenza mhux komuni.
English: EU/1/17/1195/005 1 pre-filled syringe EU/1/17/1195/006 2 pre-filled syringes EU/1/17/1195/007 4 pre-filled syringes
Maltese: EU/1/17/1195/006 EU/1/17/1195/007 EU/1/17/1195/008
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use.
Maltese: Avvenimenti ta' mard li jneħħi l-majelin tas-sistema ċentrali u periferali ġew irrapurtati b'mod rari u rari ħafna, rispettivament, bl-użu ta' etanercept.
English: Erelzi treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Maltese: .2 Pożoloġija u metodu ta' kif għandu jingħata Il-kura b'Erelzi għandha tinbeda taħt is-superviżjoni ta' tobba speċjalisti b'esperjenza fid-dijanjosi u fil-kura ta' artrite rewmatojda, artrite idjopatika taż-żgħażagħ, artrite psorjatika, ankylosing spondylitis, spondiloartrite assjali mhux radjografika, psorjasi tal-plakka jew psorjasi pedjatrika talplakka.
English: Subcutaneous use.
Maltese: Tintuża darba biss.
English: Erelzi should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years or weighing less than 62.5 kg, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years or weighing less than 62.5 kg, or in children with psoriasis below the age of 6 years or weighing less than 62.5 kg.
Maltese: Normalment, Erelzi m'għandux jintuża fi tfal b'poliartrite jew b'oligoartrite estiża ta' inqas minn sentejn jew li jiżnu inqas minn 62.5 kg, jew fi tfal ta' taħt it-12-il sena jew li jiżnu inqas minn 62.5 kg b'artrite relatata ma' entesite jew artrite psorjatika, jew fi tfal b'psorjażi ta' inqas minn 6 snin jew li jiżnu inqas minn 62.5 kg.
English: However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0.8 mg/kg subcutaneously (see section 5.1).
Maltese: Madankollu, tagħrif limitat dwar is sigurtà minn reġistru ta' pazjent jissuġġerixxi li l-profil tas-sigurtà fi tfal minn sentejn sa 3 snin huwa simili għal dak li jidher fl-adulti u tfal minn 4 snin 'il fuq, meta ddożati kull ġimgħa b'0.8 mg/kg taħt il-ġilda (ara sezzjoni 5.1).
English: Sandoz GmbH Biochemiestr.
Maltese: Sandoz GmbH Biochemiestr. 10 A-6250
English: The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Maltese: L-effikaċja ta' etanercept kienet evalwata f'205 pazjenti li kellhom artrite psorjatika fi studju randomised, double-blind u kkontrollat bil-plaċebo.
English: • Dispose of the used pen in a sharps disposal container (i.e. a puncture-resistant closable container, or similar).
Maltese: • Armi l-pinna użata f'kontenitur li fih jintremew oġġetti bil-ponta jew li jaqtgħu (jiġifieri kontenitur magħluq li ma jittaqqabx, jew simili).
English: In evaluating patients for infections, the patient's risk for relevant opportunistic infections (e.g., exposure to endemic mycoses) should be considered.
Maltese: pazjenti għal infezzjonijiet, ir-riskju tal-pazjent għal infezzjonijiet opportunistiċi rilevanti (eż. espożizzjoni għal mikożi endemika) għandu jiġi kkunsidrat.
English: • Any core educational materials for HCPs are subject to country-specific adaptation according to local regulatory requirements
Maltese: • Kull materjal edukattiv ewlieni għal HCPs huwa soġġett għal adattament speċifiku għall-pajjiż skont rekwiżiti regolatorji lokali
English: Radiographic progression: comparison of etanercept vs. methotrexate in patients with RA of < 3 years duration
Maltese: Progressjoni radjografika: paragun ta' etanercept vs. methotrexate f'pazjenti b'RA ta' < 3 snin
English: Elevated liver enzymes*
Maltese: Anemija aplastika*
English: This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in adults with non-radiographic axial spondyloarthritis, four studies in adults with plaque psoriasis, three studies in juvenile idiopathic arthritis and one study in paediatric patients with plaque psoriasis.
Maltese: Din is-sezzjoni fiha tagħrif meħud minn erba' studji randomised u kkontrollati f'adulti b'artrite rewmatojde, studju wieħed f'adulti b'artrite psorjatika, studju wieħed f'adulti b'ankylosing spondylitis, studju wieħed f'adulti bi spondiloartrite assjali mhux radjografika, erba' studji f'adulti bi psorjasi tal-plakka, tliet studji f'artrite idjopatika taż-żgħażagħ u studju wieħed fuq pazjenti pedjatriċi bi psorjasi tal-plakka.
English: Haematologic reactions
Maltese: Reazzjonijiet allerġiċi
English: Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”.
Maltese: Tużax is-siringa wara d-data ta' meta tiskadi li tidher fuq il-kaxxa ta' barra jew it-tikketta tas-siringa wara “EXP”.
English: Month 6
Maltese: 6 xhur
English: Disposal instructions
Maltese: Eliminazzjoni
English: In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of autoimmune hepatitis in patients receiving etanercept without concomitant methotrexate was 0.02% (frequency rare).
Maltese: inċidenza) ta' epatite awtoimmunitarja f'pazjenti li kienu qed jirċievu etanercept mingħajr methotrexate konkomitanti kienet ta' 0.02 % (frekwenza rari).
English: Among patients with plaque psoriasis who received etanercept, significant responses relative to placebo were apparent at the time of the first visit (2 weeks) and were maintained through 24 weeks of therapy.
Maltese: Fost pazjenti bi psorjasi tal-plakka li ngħataw etanercept, risponsi sinifikanti meta mqabbla mal plaċebo kienu apparenti fiż-żmien tal-ewwel viżta (ġimagħtejn) u nżammu matul l-24 ġimgħa tat terapija.
English: In plaque psoriasis, infiltration by inflammatory cells, including T-cells, leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Maltese: infiltrazzjoni minn ċelluli infjammatorji inklużi ċ-ċelluli-T, twassal għal żieda fil-livelli tat-TNF f'leżjonijiet psorjatiċi meta mqabblin mal-livelli fil-ġilda mhux involuta.
English: Caregivers and healthcare professionals only:
Maltese: Kategorija farmakoterapewtika:
English: Combination therapy
Maltese: MEDIĊINALI
English: Patients should be evaluated for infections before, during, and after treatment with Erelzi, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Maltese: Il-pazjenti għandhom ikunu evalwati għal infezzjonijiet qabel, matul, u wara l-kura b'Erelzi, u trid tkun ikkunsidrata li l-medja tal-half-life ta' l-eliminazzjoni ta' etanercept hi ta' madwar 70 siegħa (medda ta' 7 sa 300 siegħa).
English: • Not known (frequency cannot be estimated from the available data): Merkel cell carcinoma (a type of skin cancer); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash).
Maltese: Karċinoma taċ-ċelluli Merkel (tip ta' kanċer tal-ġilda); attivazzjoni eċċessiva ta' ċelluli bojod tad demm assoċjati ma' infjammazzjoni (sindrome tal-attivazzjoni tal-makrofagu); rikorrenza tal-epatite B
English: This card provides important safety information for patients, including information relating to infections and to worsening of congestive heart failure related to Erelzi.
Maltese: Din il-kard tipprovdi informazzjoni importanti dwar is-sigurtà għall-pazjenti, inkluż informazzjoni relatata ma' infezzjonijiet u l-iggravar ta' insuffiċjenza konġestiva tal-qalb relatati ma' Erelzi.
English: In patients who develop HBV infection, Erelzi should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Maltese: F'pazjenti li jiżviluppaw infezzjoni tal-HBV, Erelzi għandu jitwaqqaf u għandha tinbeda terapija antivirali effettiva b'kura adatta ta' appoġġ.
English: Several seconds later a 2nd click will indicate that the injection is almost finished.
Maltese: Bosta sekondi wara se tisma' t-tieni ħoss li jurik li l-injezzjoni kważi lesta.
English: There have been post-marketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4).
Maltese: Wara t-tqegħid fis-suq, kien hemm rapporti ta' panċitopenja u anemija aplastika, li x'uħud minnhom spiċċaw biex kienu fatali (ara sezzjoni 4.4).
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the etanercept in combination with methotrexate group compared with the etanercept alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p < 0.05).
Maltese: wara 24 xahar kien ogħla fil-grupp li ngħata etanercept flimkien ma' methotrexate meta mqabbel mal gruppi li ħadu etanercept waħdu u methotrexate waħdu (62%, 50%, and 36%, rispettivament;
English: Slowly release the plunger and allow the needle guard to automatically cover the exposed needle.
Maltese: Reazzjonijiet serji ematoloġiċi, newroloġiċi u awtoimmuni kienu wkoll irrappurtati.
English: Instructions for use of the Erelzi SensoReady pen
Maltese: Effetti sekondarji addizzjonali fit-tfal u l-adolexxenti
English: United Kingdom Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire RG14 1JN
Maltese: Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire RG14 1 JN
English: Cell Pharm GmbH Theodor-Heuss-Str. 52 61118 Bad Vilbel Germany
Maltese: Ġermanja cell pharm GmbH Theodor-Heuss-Str. 52 61118 Bad Vilbel Germany
English: STADA Arzneimittel GmbH, Muthgasse 36, A-1190 Wien
Maltese: STADA Arzneimittel GmbH, Muthgasse 36, A-1190
English: Germany
Maltese: Austria
English: Novgos 3.6mg Implant 3.6 mg
Maltese: Novgos 3.6 mg Implant
English: List of the names, pharmaceutical forms, strength of the medicinal product, route of administration, marketing authorisation holders in the Member States
Maltese: Lista ta` ismijiet, għamliet farmaċewtiċi, qawwa tal-prodott mediċinali, mnejn jingħata, id-detenturi ta` l-awtorizzazzjonijiet għat-tqegħid fissuq fl-istati membri
English: Novogos 3,6 mg Implantat implant, pre-filled syringe subcutaneous use
Maltese: Novogos 3,6 mg Implantat
English: Marketing authorisation holder
Maltese: Id-Detentur ta' lAwtorizzazzjoni għat-tqegħid fis-suq
English: Information for patients
Maltese: Konklużjoni globali
English: EMA restricts use of prostate cancer medicine Xofigo
Maltese: Anness IV Konklużjonijiet xjentifiċi
English: The above recommendations are based on the assessment of data from a randomised, double blind, placebo controlled phase III trial (ERA-223), which showed that there was an increased incidence of fractures (28.6% vs 11.4%), a possible reduction in median overall survival (30.7 months vs 33.3 months, HR 1.195, 95% confidence interval (CI) 0.950 - 1.505, p=0.13) and an increased risk of radiological non-bone progression (HR 1.376 [95% CIs 0.972, 1.948], p=0.07) among patients receiving Xofigo in combination with abiraterone acetate plus prednisone/prednisolone (n=401) compared to patients receiving placebo in combination with abiraterone acetate plus prednisone/prednisolone (n=405).
Maltese: Peress li s-sett tad-data evolva matul din il-proċedura, huwa nnutat li l-iżbilanċ statistikament sinifikanti fil-mortalità osservat fl-analiżi interim ta' ERA-223 meta seħħew il-miżuri proviżorji (HR 1.347; 95% CI [1.047, 1.732] p=0.02) ma baqax statistikament sinifikanti fl-analiżi wara li ġiet illokkjata l-bażi tad-data fit-8 ta' Ġunju 2018 (HR 1.195; 95% CI [0.950, 1.505] p=0.128).
English: In another randomised, double blind, placebo controlled phase III trial (ALSYMPCA), a statistically significant overall survival benefit of treatment with Xofigo could not be demonstrated in the subgroups of patients with fewer than 6 metastases (HR for radium-223 to placebo 0.901; 95% CI [0.5531.466], p=0.674) or a baseline total alkaline phosphatase (ALP) <220 U/L (HR 0.823 95% CI 0.6331.068, p=0.142), indicating that efficacy may be diminished in patients with a low level of osteoblastic activity from their bone metastases.
Maltese: F'ALSYMPCA, radium-223 dewwem b'mod sinifikanti s-sopravivenza globali fis-sottogrupp ta' utenti li ma użawx opjojdi (HR = 0.70; 95% CI [0.52-0.93]; p = 0.013), madankollu, kien hemm differenzi fil-linja bażi f'favur radium-223.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 September 2018 EMA/680161/2018
Maltese: Studju 15396 (ERA-223); NCT02043678; prova ta' fażi
English: • Xofigo should only be used as monotherapy or in combination with an LHRH analogue for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, who are in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment.
Maltese: • Bħala konsegwenza, il-PRAC irrakkomanda li l-indikazzjoni ta' radium-223 tiġi ristretta għal użu bħala monoterapija jew flimkien ma' analogu ta' ormon li jistimula l-produzzjoni tal-ormon ta' lutejinazzjoni (LHRH), għall-kura ta' pazjenti adulti b'kanċer tal-prostata reżistenti għallkastrazzjoni metastatiku (mCRPC), metastasi sintomatika fl-għadam u l-ebda metastasi vixxerali magħrufa, fi progressjoni wara tal-inqas żewġ linji preċedenti ta' terapija sistemika għal mCRPC (minbarra analogi ta' LHRH), jew ineliġibbli għal kwalunkwe kura ta' mCRPC sistemika disponibbli.
English: More about the medicine
Maltese: Billi,
English: The PRAC's recommendations were endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP).
Maltese: Id-data interim minn REASSURE tindika wkoll użu konkomitanti ma' enzalutamide (22%).
English: • Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone.
Maltese: B'mod globali, il-PRAC qies li l-kontraindikazzjoni introdotta meta saru l-miżuri provviżorji għall-użu ta' radium-223 flimkien ma' abiraterone u prednisone/prednisolone għandha tinżamm.