FrancophonIA/ELRC3.0 huggingface dataset:
English: In conclusion, taking into account the serious cardiac and neurological adverse events associated with the use of buflomedil-containing medicinal products under normal conditions of use, the evidence of limited clinical efficacy which is insufficient to compensate for the risks associated with the use of buflomedil and the established concerns regarding the effectiveness of the risk minimisation measures, the CHMP considered that the risk-benefit balance of buflomedil-containing medicinal products is not positive under normal conditions of use.
Maltese: Bħala konklużjoni, b'kunsiderazzjoni tal-avvenimenti avversi serji kardijaċi u newroloġiċi assoċjati mal-użu ta' prodotti mediċinali li fihom il-buflomedil taħt kundizzjonijiet normali ta' użu, l-evidenza ta' effikaċja klinika limitata li mhijiex biżżejjed biex tikkumpensa għar-riskji assoċjati mal-użu talbuflomedil u t-tħassib stabbilit dwar l-effikaċja tal-miżuri għall-minimizzazzjoni tar-riskju, is-CHMP ikkunsidra li l-bilanċ tar-riskju-benefiċċju ta' prodotti mediċinali li fihom il-buflomedil mhuwiex pożittiv taħt kundizzjonijiet normali ta' użu.
English: In summary, the CHMP concluded that the use of buflomedil is associated with a number of serious cardiological (mainly tachycardia, hypotension, ventricular rhythm disorders and cardiac arrest) and neurological (mainly convulsions, myoclonia and status epilepticus) adverse events, which occur under normal conditions of use, particularly in elderly patients, who are predominantly the patient population relevant to the approved indication.
Maltese: Fil-qosor, is-CHMP ikkonkluda li l-użu tal-buflomedil huwa assoċjat ma' għadd ta' avvenimenti serji kardjoloġiċi (prinċipalment takikardja , pressjoni baxxa, disturbi fir-ritmu ventrikulari u arrest kardijaku) u newroloġiċi (prinċipalment konvulżjonijiet, majoklonja u status epilepticus), li jseħħu taħt kundizzjonijiet normali ta' użu, partikularment f'pazjenti anzjani, li predominantement huma lpopolazzjoni ta' pazjenti rilevanti għall-indikazzjoni approvata.
English: The MAH review of the ICSR database identified 33 cases involving the use of a maximum daily dose of 600 mg. From these, a total of 21 cases of neurological adverse events were retrieved.
Maltese: Ir-reviżjoni tal-MAH tad-database tal-ICSR identifikat 33 każ li kienu jinvolvu l-użu ta' doża massima ta' kuljum ta' 600 mg.
English: In addition, the CHMP noted the evidence of limited clinical efficacy of buflomedil, as demonstrated in recent clinical trials.
Maltese: Barra minn hekk, is-CHMP innota l-evidenza tal effikaċja klinika limitata tal-buflomedil, kif intweriet fil-provi kliniċi riċenti.
English: The CHMP also carried out a separate assessment of the safety of the parenteral formulations of buflomedil, which are used in the hospital setting for the treatment of severe chronic ischaemia of the lower limbs.
Maltese: Is-CHMP wettaq ukoll valutazzjoni separata dwar is-sigurtà tal-formulazzjonijiet parenterali talbuflomedil, li jintużaw fl-isptarijiet fil-kura ta' iskemija severa kronika tal-riġlejn.
English: The CHMP concluded that due to the similarities between the proposed RMMs and the ones implemented in France, it is possible to conclude on the effectiveness of the proposed RMMs, despite the lack of implementation in all member states and that these measures are inadequate to prevent the occurrence of serious adverse events with buflomedil.
Maltese: Is-CHMP ikkonkluda li minħabba s-similaritajiet bejn l-RMMs proposti u dawk implimentati fi Franza, huwa possibbli li jiġi konkluż dwar l-effikaċja tal-RMMs proposti, minkejja n-nuqqas ta' implimentazzjoni fl-istati membri kollha u li dawn ilmiżuri mhumiex adegwati biex iwaqqfu l-okkorrenza ta' avvenimenti avversi serji bil-buflomedil.
English: Regarding risk minimisation measures, the CHMP noted the MAH proposals but considered that these are unlikely to be sufficient to prevent the occurrence of serious cardiac and neurological adverse events under normal conditions of use nor reduce the well identified risks of accidental overdoses and non-compliance with renal function monitoring associated with the use of buflomedil to an acceptable level.
Maltese: Fir-rigward tal-miżuri għall-minimizzazzjoni tar-riskju, is-CHMP innota l-proposti tal-MAH imma kkunsidra li dawn mhumiex probabbli li jkunu biżżejjed biex jipprevjenu l-okkorrenza ta' avvenimenti avversi serji kardijaċi u newroloġiċi taħt kundizzjonijiet normali ta' użu u lanqas ma jnaqqsu r-riskji identifikati sew ta' dożi eċċessivi aċċidentali u ta' nuqqas ta' konformità malmonitoraġġ tal-funzjoni renali assoċjat mal-użu tal-buflomedil għal livell aċċettabbli.
English: The CHMP assessed the impact of the risk minimisation measures previously implemented in France, consisting mainly of revisions to the SmPC and communication and noted the proposed extension of these measures to other member states.
Maltese: Is-CHMP evalwa l-impatt tal-miżuri għall-minimizzazzjoni tar-riskju preċedentement implimentati fi Franza, li prinċipalment kienu jikkonsistu minn reviżjonijiet għall-SmPC u komunikazzjoni u nnota lestensjoni proposta ta' dawn il-miżuri lil stati membri oħra.
English: • The Committee therefore concluded, in view of the available data, that the risks of serious cardiac and neurological adverse events associated with the use of buflomedil-containing medicinal products in the symptomatic treatment of chronic peripheral vascular disease, under normal conditions of use, outweigh the limited benefits.
Maltese: • Il-Kumitat għalhekk ikkonkluda, fid-dawl tad-dejta disponibbli, li r-riskji ta' avvenimenti avversi serji kardijaċi u newroloġiċi assoċjati mal-użu ta' prodotti mediċinali li fihom il-buflomedil filkura sintomatika ta' mard vaskulari periferali kroniku, taħt kundizzjonijiet normali ta' użu, jegħlbu l-benefiċċji limitati.
English: Consequently, the CHMP recommended to the European Commission the suspension of the Marketing Authorisations of buflomedil-containing medicinal products listed in Annex I of the Opinion in all concerned EU Member States.
Maltese: Awtorizzazzjonijiet għat-Tqegħid fis-Suq ta' prodotti mediċinali li fihom il-buflomedil elenkati flAnness I tal-Opinjoni fl-Istati Membri kollha kkonċernati tal-UE.
English: Discussion on efficacy
Maltese: L-istudju osservazzjonali
English: The MAH review of the ICSR database identified 5 cases with known dosage occurring in elderly patients for whom dosage adjustment was required.
Maltese: Ir-reviżjoni tal-MAH tad-database tal-ICSR identifikat 5 każi b'dożaġġ magħruf li seħħew f'pazjenti anzjani li kienu jeħtieġu aġġustament tad-doża.
English: Serious cardiovascular and neurological adverse events in elderly patients and patients with renal impairment
Maltese: Avvenimenti avversi serji kardjovaskulari u newroloġiċi f'pazjenti anzjani u f'pazjenti b'indeboliment renali
English: One patient experienced convulsions after taking two 300 mg tablets at the same time instead of two tablets BID.
Maltese: Pazjent wieħed esperjenza konvulżjonijiet wara li kien ħa żewġ pilloli ta' 300 mg flistess ħin minflok żewġ pilloli BID.
English: Following these enquiries, France took a number of national regulatory actions to minimise the risk of adverse events associated with buflomedil.
Maltese: Wara dawn l-inkjesti, Franza ħadet numru ta' azzjonijiet regolatorji nazzjonali biex timminimizza r-riskju ta' avvenimenti avversi assoċjati mal-buflomedil.
English: Having assessed the risk minimisation measures proposed by the MAH, the CHMP concluded that given the high risk with buflomedil, notably in patients with advanced vascular disease and/or diabetes and metabolic syndrome, in patients with impaired renal function and in elderly patients, no adequate or sufficient measures could be identified to reduce the risks associated with buflomedil to an acceptable level.
Maltese: Wara li evalwa ttotalità tal-miżuri għall-minimizzazzjoni tar-riskju proposti mill-MAH, is-CHMP ikkonkluda li minħabba r-riskju ogħli bil-buflomedil, speċjalment f'pazjenti b'indeboliment tal-funzjoni renali u f'pazjenti anzjani, ma setgħu jiġu identifikati l-ebda miżuri biex inaqqsu r-riskji assoċjati malbuflomedil għal livelli aċċettabbli.
English: Having assessed the totality of the risk minimisation measures proposed by the MAH, the CHMP concluded that given the high risk with buflomedil, notably in patients with impaired renal function and in elderly patients, no measures could be identified to reduce the risks associated with buflomedil to an acceptable level.
Maltese: Fir-rigward tal-attivitajiet addizzjonali ta' farmakoviġilanza proposti, is-CHMP kien tal-opinjoni li s-sejbien ta' sinjal ma għadux prijorità, minħabba li r-riskji assoċjati mal-buflomedil issa ġew identifikati u kkonfermati.
English: • The Committee considered that in this context, the narrow therapeutic index of buflomedil is of major concern, as patients with peripheral vascular disease treated with buflomedil are inherently likely to experience decreased renal function, due to the nature of their condition.
Maltese: • Il-Kumitat ikkunsidra li f'dan il-kuntest, l-indiċi terapewtiku dejjaq tal-buflomedil huwa ta' tħassib maġġuri, peress li pazjenti b'mard vaskulari periferali li jirċievu kura bil-buflomedil huma intrinsikament probabbli li jesperjenzaw tnaqqis fil-funzjoni renali, minħabba n-natura tal-kundizzjoni tagħhom.
English: However, the CHMP noted that the analysis did not demonstrate statistical significance and that the results therefore did not allow to conclude on a statistically significant reduction in the combined primary endpoint compared to placebo.
Maltese: Madankollu, is-CHMP innota li l-analiżi ma wrietx sinifikanza statistika u li r-riżultati għalhekk ma kienux jippermettu li jiġi konkluż dwar tnaqqis statistikament sinifikanti fl-endpoint primarju kkombinat meta mqabbel ma' plaċebo.
English: However, the CHMP considered that the risk minimisation measures proposed by the MAH are unlikely to reduce the serious cardiac and neurological adverse events associated with the use of buflomedil to a clinically acceptable level.
Maltese: Madankollu, is-CHMP ikkunsidra li lmiżuri għall-minimizzazzjoni tar-riskju proposti mill-MAH mhumiex probabbli li jnaqqsu lavvenimenti avversi serji kardijaċi u newroloġiċi assoċjati mal-użu tal-buflomedil għal livell klinikament aċċettabbli.
English: In addition, review of all available individual case safety data related to buflomedil identified 28 cases of overdoses in elderly patients (over 65
Maltese: Barra dan, reviżjoni taddejta kollha disponibbli dwar każi individwali ta' sigurtà relatati mal-buflomedil identifikat 28 każ ta' dożi eċċessivi f'pazjenti anzjani ('il fuq minn 65 sena).
English: Following an oral explanation held in July 2011, the MAH was requested to propose further risk minimisation measures and asked whether a restricted population could be identified.
Maltese: Wara spjegazzjoni orali li saret f'Lulju 2011, il-MAH intalab jipproponi miżuri ulterjuri għallminimizzazzjoni tar-riskju u ġie mistoqsi jekk setgħetx tiġi identifikata popolazzjoni ristretta.
English: Following a European PSUR assessment and a full benefit-risk assessment completed by the MAH in January 2010, the MAH proposed a number of measures to address the identified concerns.
Maltese: Wara valutazzjoni tal-PSUR Ewropew u valutazzjoni sħiħa tal-benefiċċju-riskju li tlestiet mill-MAH f'Jannar 2010, il-MAH ippropona għadd ta' miżuri biex jindirizza t-tħassib identifikat.
English: Strength Pharmaceuti cal form
Maltese: Qawwa Għamla Farmaċewtika
English: (Invente d) name
Maltese: Numru ta' l-EU Isem (ivvintat)
English: Product invented name
Maltese: Isem inventat talprodott
English: Enurace 50 Tablets
Maltese: Enurace 50
English: Enurace has been officially authorised since 2000 (since 1995 available in the Netherlands).
Maltese: Enurace ilu awtorizzat uffiċjalment sa mill-2000 (disponibbli fl-Olanda sa mill-1995).
English: ACE Pharmaceuticals BV
Maltese: ACE Pharmaceuticals
English: The Netherlands, Belgium, Germany, France, Italy, Spain and the United Kingdom.
Maltese: L-Olanda, il-Belġju, ilĠermanja, Franza, l-Italja, Spanja u r-Renju Unit.
English: Introduction and background
Maltese: Introduzzjoni u Sfond
English: At Day 90 of the MRP, 27 September 2006, France and Italy could not agree to the granting of a marketing authorization as they consider there are potentially serious risks for animal health.
Maltese: Fid-disgħin jum ta' l-MRP, fis-27 ta' Settembru 2006, Franza u l-Italja ma setgħux jaqblu ma' l-għoti ta' l-awtorizzazzjoni għat-tqegħid fis-suq għax qiesu li kien hemm riskji potenzjali serji għas-saħħa ta' l-annimali.
English: However, the study where Enurace 50 is compared to Propaline (ACE129802) is convincing although a non-inferiority analysis has not been performed.
Maltese: Madankollu, l-istudju li fih, Enurace 50 tqabbel ma' Propaline (ACE129802) huwa wieħed konvinċenti għalkemm ma saritx analiżi non-inferiority.
English: For the reason of very limited treatment options, high risk of euthanasia if treatment fails or is not affordable, ephedrine is a substance of other eventual choice - Propalin instead Enurace and vice versa, considering that sympathicomimetic treatment of urinary incontinence is far better than hormonal treatment (an alternative is surgical therapies as colposuspension, urethropexy and the endoscopic injection of collagen in refractory cases).
Maltese: Minħabba l-għażliet limitati ħafna ta' trattament, riskju qawwi ta' ewtanasija jekk it-trattament ma jirnexxix jew jekk dan ma jkunx finanzjarjament sostenibbli, l-efedrina hija sustanza oħra li tista' tkun għażla eventwali - Propalin minflok Enurace u viċi versa, meta wieħed jikkonsidra li trattament simpatikomimetiku ta' l-inkontinenza awrinarja hu ferm aħjar minn trattament ormonali (alternattivi oħra huma terapiji kirurġiċi bħal colposuspension, urethropexy u l-injezzjoni endoskopika tal-kollaġen f'każijiet refrattorji).
English: The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) for a 60 day procedure in accordance with Article 33(1) of Directive 2001/82/EC, as amended.
Maltese: Il-kwistjoni ġiet riferuta lill-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u lProċeduri Deċentralizzati (CMD(v)) għal perjodu ta' 60 jum skond l-Artikolu 33(1) tad-Direttiva 2001/82/KE, kif emendata.
English: The application was made in accordance with Article 12.3 of Directive 2001/82/EC as a stand alone application.
Maltese: L-applikazzjoni saret skond l-Artikolu 12.3 tad-Direttiva 2001/82/KE bħala applikazzjoni weħidha.
English: The raw outcome shows good effect in both test and control groups (87% vs 85.5%), an effect that might be somewhat higher in treatment naïve animals (93.7% vs 88.9%).
Maltese: Ir-riżultati qabel l-analiżi wrew effett tajjeb kemm fil-grupp ittestjat kif ukoll fil-grupp ta' kontroll (87% vs 85.5%), effett li jaf ikun ftit jew wisq ikbar fit-trattament ta' annimali naïve (93.7% vs 88.9%).
English: Section 4.5 of the SPC and Section 12 of the Package Leaflet:
Maltese: Sezzjoni 4.5 ta' l-SPC u s-Sezzjoni 12 tal-Fuljett ta' Tagħrif:
English: The CVMP during its meeting of December 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Enurace 50.
Maltese: Is-CVMP waqt il-laqgħa tiegħu ta' Diċembru ta' l-2006 beda proċedura ta' riferiment skond l-Artikolu 33(4) tad-Direttiva 2001/82/KE kif emendata għal Enurace 50.
English: France considers the risk/benefit analysis unfavourable for the animal when the adverse effects (in very rare cases atrium fibrillation and tachycardia) are weighed against the potential benefits of effective treatment of incontinence.
Maltese: Franza tqis li l-analiżi tar-riskju meta mqabbel mal-benefiċċju huwa wieħed sfavorevoli għall-annimali meta l-effetti sekondarji (każijijiet rari ħafna ta' fibrazzjoni atrijali u takikardija) jitqabblu malbenefiċċji potenzjali ta' trattament effettiv ta' l-inkontinenza.
English: The data provided by the applicant show that Enurace 50 is an effective medicinal product for treatment of urinary incontinence in ovariohysterectomised bitches.
Maltese: Id-dejta pprovduta mill-applikant turi li Enurace 50 hu prodott mediċinali effettiv għat-trattament ta' linkontinenza awrinarja fi klieb nisa li jkunu tneħħewlhom l-ovarji u l-utru.
English: This procedure ended on 28 November 2006.
Maltese: Din il-proċedura ntemmet fit-28 ta' Novembru 2006.
English: A Mutual Recognition Procedure started on 29 June 2006 with The Netherlands as Reference Member State and Belgium, Germany, Spain, France, Italy and the United Kingdom as Concerned Member States.
Maltese: Fid-29 ta' Ġunju 2006 inbdiet Proċedura tar-Rikonoxximent Reċiproku (MRP) bl-Olanda bħala l-Istat Membru ta' Referenza u l-Belġju, il-Ġermanja, Spanja, Franza, l-Italja u r-Renju Unit bħala Stati Membri Konċernati.
English: The Marketing Authorisation Holder should provide all supporting data (preclinical and clinical documentation, including the expert reports, efficacy and tolerance studies conducted), to justify a positive benefit-risk ratio for the treated animal.
Maltese: Is-Sid ta' l-Awtorizzazzjoni għatTqegħid fis-Suq irid jipprovdi d-dejta kollha relevanti (dokumentazzjoni klinika u preklinika, inkluż rapporti ta' esperti, l-istudji tat-tolleranza u ta' l-effikaċja li jkunu saru), biex jiġġustifika proporzjon favorevoli tal-benefiċċju-riskju għall-annimal taħt il-kura.
English: The CVMP has concluded that the risk/benefit for this product is favourable.
Maltese: Is-CVMP ikkonkluda li r-riskju/benefiċċju għal dan il-prodott huwa wieħed favorevoli.
English: These figures seem highly convincing when compared to the 20 % placebo treated animals that became continent in study ACE129801.
Maltese: Dawn il-figuri jidhru konvinċenti ħafna meta mqabbla ma' l-20% ta' l-annimali ttrattati bil-plaċebo li saru kontinenti fl-istudju ACE129801.
English: In response to the questions related to toxicity, the applicant argues that due to the pharmacologic effect of ephedrine and the individual variation in receptor density no safety margin can be determined and increasing doses will be associated to increased intensity and frequency of well known adverse effects.
Maltese: Bi tweġiba għall-mistoqsijiet relatati mat-tossiċità, l-applikant argumenta li minħabba l-effett farmakoloġiku ta' l-efedrina u l-varjazzjoni individwali fid-densità tar-riċetturi, ma jista' jkun stabbilit l-ebda limitu ta' sigurtà u żidiet fid-dożi huma assoċjati ma' żieda fl-intensità u l-frekwenza ta' effetti sekondarji magħrufa.
English: Since 1998 post-marketing studies have been performed as well as regular monitoring of adverse effects by FAQ system.
Maltese: Mill-1998 bdew isiru studji ta' wara t-tqegħid fis-suq kif ukoll sorveljanza regolari ta' l-effetti sekondarji permezz ta' sistema ta' tweġibiet ta' l-iktar mistoqsijiet komuni dwar il-prodott.
English: Frequency and route of administration
Maltese: Frekwenza u mnejn jingħata
English: Proposed dose of 1 - 3 mg Ephedrine HCl /kg/day, divided in two oral doses is effective and safe, but some animals may need a higher dose, which is associated with individual variation in the response to ephedrine.
Maltese: Id-doża proposta ta' 1 - 3 mg Ephedrine HCl/kg kuljum, diviża f'żewġ dożi orali hi effettiva u sigura, iżda xi annimali jista' jkollhom bżonn dożi ikbar, li jkunu assoċjati ma' varjazzjoni individwali fir-rispons għall-efedrina.
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel: (44-20) 74 18 84 00 Fax: (44-20) 74 18 84 47 E-Mail: mail@emea.europa.eu http://www.emea.europa.eu
Maltese: Is-Sommarju tal-Karatteristiċi tal-Prodott, l-ittikkettar u l-fuljett ta' tagħrif validi huma l-verżjonijiet finali miksuba waqt il-proċedura tal-Grupp tal-Koordinazzjoni bl-emendi li ġejjin:
English: 50 mg Female dogs
Maltese: 50 mg Klieb nisa Għal għoti fil-ħalq biss, għandha tingħata ma' likel
English: CMD(v) could not reach an agreement by day 60 of this procedure, as France and Italy maintained their concerns.
Maltese: Is-CMD(v) ma setax jilħaq qbil sas-sittin jum ta' din il-proċedura, billi Franza u l-Italja baqgħu jsostnu t-tħassib tagħhom.
English: A starting dose of 2 mg Ephedrine HCl per kg of bodyweight per day, divided in two oral doses is recommended.
Maltese: Doża tal-bidu ta' 2 mg Ephedrine HCl għal kull kg tal-piż tal-ġisem kuljum, maqsuma f'żewġ dożi orali.
English: Although the influence of age was not reflected in the tolerance studies, it was taken into account in the efficacy and post- marketing studies.
Maltese: Għalkemm l-influwenza ta' l-età ma kinitx riflessa fl-istudji tat-tolleranza, din ġiet ikkunsidrata flistudji dwar l-effikaċja u ta' wara t-tqegħid fis-suq.
English: Italy could accept the application with revised wording in the SPC .
Maltese: L-Italja tista' taċċetta l-applikazzjoni b'formolazzjoni riveduta ta' l-SPC.
English: The dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment.
Maltese: Il-funzjonalità kardjovaskulari tal-kelb għandha tkun assessjata bir-reqqa qabel il-bidu tat-trattament bl-Enurace 50 u għandha tkun monitorjata perjodikament matul it-trattament.
English: At the recommended dose level, which according to the suggested SPC should be individually adjusted, safety is ensured to a reasonable level.
Maltese: Fil-livell tad-doża rakkomandata, li skond l-SPC huwa ssuġġerit li din trid tkun aġġustata individwalment, is-sigurtà hija raġjonevolment assigurata.
English: Enurace 50 was first authorised in The Netherlands on 15 September 2000.
Maltese: Enurace 50 ġie awtorizzat għall-ewwel darba fl-Olanda fil-15 ta' Settembru 2000.
English: Consequently the matter was referred to the CVMP.
Maltese: Konsegwentament il-kwistjoni ġiet riferuta lis-CVMP.
English: European Medicines Agency Veterinary Medicines and Inspections
Maltese: Għamla farmaċewtika
English: Empliciti (elotuzumab)
Maltese: Empliciti (elotużumab)
English: Further information on Empliciti can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/empliciti.
Maltese: ema.europa.eu/medicines/human/EPAR/empliciti.
English: Empliciti received a marketing authorisation valid throughout the EU on 11 May 2016.
Maltese: Empliciti rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fil11 ta' Mejju 2016.
English: Empliciti contains the active substance elotuzumab.
Maltese: Empliciti fih is-sustanza attiva elotużumab.
English: Other information about Empliciti
Maltese: Informazzjoni oħra dwar Empliciti
English: Empliciti is given as an infusion (drip) into a vein.
Maltese: Empliciti jingħata bħala infużjoni (dripp) ġol-vina.
English: Patients' previous treatment should have included the multiple myeloma medicines lenalidomide and a class of medicines called proteasome inhibitors (e.g. bortezomib, carfilzomib and ixazomib).
Maltese: Il-kura preċedenti tal-pazjenti għandha tkun inkludiet il-mediċini kontra l-mijeloma multipla lenalidomide u klassi tal-mediċini msejħa inibituri tal-proteasome (eż. bortezomib, carfilzomib u ixazomib).
English: What are the risks associated with Empliciti?
Maltese: X'inhuma r-riskji assoċjati ma' Empliciti?
English: The most common side effects with Empliciti (which may affect more than 1 in 10 people) are headache, tiredness, fever, diarrhoea, sore throat, nose and throat infections, cough, pneumonia (lung infection), low levels of white blood cells and weight loss.
Maltese: L-effetti sekondarji l-aktar komuni b'Empliciti (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) huma wġigħ ta' ras, għeja, deni, dijarea, uġigħ fil-griżmejn, infezzjonijiet fl-imnieħer u filgriżmejn, sogħla, pulmonite (infezzjoni fil-pulmun), livelli baxxi ta' ċelluli bojod tad-demm u telf tal-piż.
English: In a main study of 646 multiple myeloma patients a combination of Empliciti plus lenalidomide and dexamethasone was compared with only lenalidomide and dexamethasone.
Maltese: Fi studju ewlieni fuq 646 pazjent b'mijeloma multipla kombinazzjoni ta' Empliciti flimkien ma' lenalidomide u dexamethasone tqabblet ma' lenalidomide u dexamethasone waħidhom.