FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with a certain human leukocyte antigen genotype (which is more frequent in Japanese and Korean patients, but is also found in Caucasians) are more prone to development of insulin autoimmune syndrome (disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels) when treated with thioctic acid.
Maltese: Pazjenti b'ċertu ġenotip ta' antiġenu tal-lewkoċiti tal-bniedem (li huwa iktar frekwenti f'pazjenti Ġappuniżi u Koreani, iżda li jinsab ukoll fil-Kawkażi) huma iktar suxxettibbli għall-iżvilupp tas-sindrome awtoimmuni tal-insulina (disturb tal-ormoni li jirregolaw iz-zokkor fid-demm bi tnaqqis qawwi fil-livelli taz-zokkor fid-demm) meta jiġu kkurati bl-aċidu tijottiku.
English: Cases of Insulin Autoimmune Syndrome (IAS) have been reported during treatment with thioctic acid.
Maltese: Ġew irrapportati każijiet ta' Sindrome Awtoimmuni tal-Insulina (SAI) bl-aċidu tijottiku.
English: Thioctic acid - Insulin autoimmune syndrome (EPITT no
Maltese: 3. Aċidu tijottiku - Sindrome awtoimmuni tal-insulina (EPITT nru 18406)
English: Pulmonary symptoms, such as cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate.
Maltese: Sintomi pulmonari, bħal sogħla u qtugħ ta' nifs, jistgħu jiġġustifikaw il-waqfien tat-terapija u investigazzjoni ulterjuri, kif ikun xieraq.
English: Frequency unknown: Disorder of the blood glucose regulating hormones with pronounced lowering of blood sugar levels (insulin autoimmune syndrome).
Maltese: Disturb tal-ormoni li jirregolaw iz-zokkor fid-demm bi tnaqqis qawwi fillivelli taz-zokkor fid-demm (sindrome awtoimmuni tal-insulina).
English: The full EPAR for Trisenox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effects with Trisenox (seen in 1 patient in 10) are hyperglycaemia (high blood glucose levels), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels), paraesthesia (unusual sensations like pins and needles), dizziness, headache, tachycardia (rapid heartbeat), dyspnoea (difficulty breathing), differentiation syndrome (a potentially fatal complication of chemotherapy in patients with APL), diarrhoea, vomiting, nausea (feeling sick), pruritus (itching), rash, myalgia (muscle pain), pyrexia (fever), pain, fatigue (tiredness), oedema (swelling), prolonged QT interval on an electrocardiogram (an alteration of the electrical activity of the heart), and increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes).
Maltese: L-effetti sekondarji l-aktar komuni bi Trisenox (li dehru f'pazjent 1 minn 10) huma ipergliċemija (livelli għoljin ta' glukożju fid-demm), ipomagneżjemija (livelli baxxi ta' manjeżju fid-demm), ipokalemija (livelli baxxi ta' potassju fid-demm), paresteżija (sensazzjonijiet anormali bħat-tnemnim), sturdament, uġigħ ta' ras, takikardja (taħbit il-qalb mgħaġġel), dispnea (diffikultà fit-teħid tan-nifs), sindromu ta' differenzjazzjoni (kumplikazzjoni li tista' tkun fatali tal-kimoterapija f'pazjenti bl-APL), dijarrea, remettar, nawżja (dardir), prurite (ħakk), raxx, milaġija (uġigħ fil-ġogi), piressija (deni), uġigħ, għejja, edema (nefħa), interval QT imtawwal f'elektrokardjogramm (alterazzjoni tal-attività elettrika tal-qalb), u aktar livelli ta' alanina aminotransferase u aspartate aminotransferase (enżimi tal-fwied).
English: Patients with APL are normally treated with retinoids (substances derived from vitamin A).
Maltese: Pazjenti bl-APL huma normalment ikkurati bir-retinojdi (sustanzi derivati mill-vitamina A).
English: Other information about Trisenox
Maltese: Informazzjoni oħra dwar Trisenox
English: 97% (72 out of 74) of patients treated with Trisenox did not have any event, compared with 86% (65 out of 76) of those treated with anthracyclines.
Maltese: 97% (72 minn 74) tal-pazjenti kkurati bi Trisenox ma kellhom l-ebda avveniment, mqabbla ma' 86% (65 minn 76) ta' dawk ikkurati b'antriċiklini.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 10 August 2010.
Maltese: Peress li l-kumpanija pprovdiet l-informazzjoni addizzjonali mitluba, iċ-"ċirkostanzi ta' eċċezzjoni" ntemmu fl-10 ta' Awwissu 2010.
English: Trisenox contains the active substance arsenic trioxide.
Maltese: Trisenox fih is-sustanza attiva trijossidu arseniku.
English: This is a summary of the European public assessment report (EPAR) for Trisenox.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Trisenox.
English: The treatment is divided into 2 phases: induction and consolidation.
Maltese: Il-kura hija maqsuma f'żewġ fażijiet: induzzjoni u konsolidazzjoni.
English: Why is Trisenox approved?
Maltese: Għaliex ġie approvat Trisenox?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trisenox on 5 March 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Trisenox fil-5 ta' Marzu 2002.
English: Trisenox has also been investigated in two studies involving a total of 52 patients with APL who had been previously treated with an anthracycline and a retinoid.
Maltese: Trisenox ġie investigat ukoll f'żewġ studji li involvew total ta' 52 pazjent bl-APL li ġew ikkurati preċedentement b'antraċiklina u b'retinojde.
English: What are the risks associated with Trisenox?
Maltese: X'inhuma r-riskji assoċjati ma' Trisenox?
English: If this does not happen by day 50 (for previously treated patients) or by day 60 (for newly diagnosed patients), the treatment should be stopped.
Maltese: Jekk dan ma jseħħx sal-jum 50 (għallpazjenti li kienu kkurati preċedentement) jew sal-jum 60 (għall-pazjenti li jkunu għadhom kemm ġew dijanjostikati), il-kura għandha titwaqqaf.
English: Trisenox is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes).
Maltese: Trisenox jintuża għall-kura ta' adulti (minn 18-il sena 'l fuq) li jbatu minn lewkimja promjeloċitika akuta (APL), forma rari ta' lewkimja (kanċer taċ-ċelloli bojod tad-demm) ikkawżata minn 'trażlokazzjoni' ġenetika (meta jkun hemm tpartiti ta' ġene bejn żewġ kromożomi).
English: • Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid (ATRA).
Maltese: • Pazjenti li għadhom kemm ġew dijanjostikati b'riskju żgħir jew intermedju ta' APL meta jintuża flimkien mal-mediċina aċidu transretinojtiku kollu (ATRA).
English: Trisenox was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Maltese: Oriġinarjament Trisenox kien awtorizzat taħt “ċirkostanzi ta' eċċezzjoni”, għaliex, minħabba li l-marda hija rari, kienet disponibbli informazzjoni limitata fi żmien l-approvazzjoni.
English: The active substance in Trisenox, arsenic trioxide, is a chemical that has been used in medicines for many years, including for the treatment of leukaemia.
Maltese: Is-sustanza attiva fi Trisenox, it-trijossidu arseniku, hija kimika li ntużat f'mediċini għal ħafna snin, inkluż għall-kura tal-lewkimja.
English: Forty-five of the patients in the studies were adults.
Maltese: Ħamsa u erbgħin mill-pazjenti fl-istudji kienu adulti.
English: Trisenox arsenic trioxide
Maltese: Sommarju tal-EPAR għall-pubbliku trijossidu arseniku
English: How does Trisenox work?
Maltese: Kif jintuża Trisenox?
English: Trisenox has been investigated in 159 newly diagnosed patients who had not yet received any treatment for APL. Trisenox was compared with an anthracycline (a type of cancer medicine), both taken in combination with ATRA, and the measure of effectiveness was the number of patients who did not experience any event (such as worsening of their disease or death) 2 years after diagnosis.
Maltese: Trisenox tqabbel ma' antraċiklina (tip ta' mediċina kontra l-kanċer), it-tnejn meħudin f'kombinazzjoni mal-ATRA, u l-kejl tal-effikaċja kien in-numru ta' pazjenti li ma esperjenzaw lebda avveniment (bħall-aggravar tal-marda taghom jew mewt) sentejn wara d-dijanjożi.
English: For the full list of all side effects and restrictions with Trisenox, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha bi Trisenox, ara l-fuljett ta' tagħrif.
English: The recommended dose of Trisenox depends on the body weight of the patient.
Maltese: Id-doża rakkomandata ta' Trisenox tiddependi mill-piż tal-ġisem tal-pazjent.
English: Trisenox was not compared with any other medicine in either study.
Maltese: Trisenox ma tqabbel mal-ebda mediċina oħra f'kull studju li sar.
English: The hazard ratio for mortality (cilostazol vs. placebo) was 0.94, 95% CI [0.63-1.39].
Maltese: Il-proporzjon ta' periklu għall-mortalità (ilkilostażolu vs. plaċebo) kien ta' 0.94, 95% CI [0.63-1.39].
English: It was noted that there was a small excess of cases of heart failure (cilostazol: 2.9%, vs. placebo: 2.4%) and hypotension (cilostazol: 0.7%, vs. placebo: 0.1%) in the CASTLE study.
Maltese: Ġie osservat li kien hemm eċċess żgħir ta' każi ta' insuffiċjenza kardijaka (ilkilostażolu: 2.9%, vs. plaċebo: 2.4%) u pressjoni baxxa (tal-kilostażolu: 0.7%, vs. plaċebo: 0.1%) fl-istudju CASTLE.
English: Cilostazol is mainly metabolised by CYP3A4, and CYP2C19 and has two main active metabolites, OPC13015 (dehydrocilostazol, 3-7 times more potent than cilostazol), and OPC-13213 (trans-hydroxycilostazol, 2 - 5 times less potent than cilostazol).
Maltese: Il-kilostażolu hija metabolizzat l-iktar minn CYP3A4, u CYP2C19 u għandu żewġ metaboliti attivi ewlenin, OPC-13015 (dehydrocilostazol, 3-7 drabi iktar qawwi mill-kilostażolu), u OPC-13213 (trans-idrossi-cilostazol, 2 - 5 drabi inqas qawwi minn cilostazol).
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC on cilostazolcontaining medicinal products;
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE dwar prodotti mediċinali li fihom il-kilostażolu;
English: The range of improvement was between +28% to +100% for cilostazol, and -10% to +42% for placebo in the individual trials.
Maltese: Il-medda ta' titjib kienet tvarja bejn +28% u +100% għall-kilostażolu, u -10% sa +42% għall-plaċebo fil-provi individwali.
English: Palpitations and tachycardia were well-documented in clinical trials.
Maltese: Il-palpitazzjonijiet u t-takikardija kienu dokumentati sew fil-provi kliniċi.
English: A pooled meta-analysis of these trials using the ratio of geometric means for LOG (ACD at last visit/ACD at baseline) for cilostazol vs. placebo demonstrated a treatment effect of 1.15 (95% CI: 1.11 - 1.19) for ACD.
Maltese: Metanaliżi raggruppata ta' dawn il-provi kliniċi bl-użu tal-proporzjon ta' mezzi ġeometriċi għal LOG (ACD fl-aħħar żjara/ACD tax-xenarju bażi) għall-kilostażolu kontra plaċebo wriet effett tal-kura ta' 1.15 (95% CI: 1.11 - 1.19) għal ACD.
English: Benefit -risk balance
Maltese: Bilanċ bejn il-benefiċċji u r-riskji
English: This reduced dose has been shown to be clinically effective in clinical trials in patients using CYP3A4 or CYP2C19 inhibitors.
Maltese: Intwera li din id-doża mnaqqsa għandha tkun klinikament effettiva fi provi kliniċi f'pazjenti li jużaw l-inibituri CYP3A4 jew CYP2C19.
English: In view of this, the CHMP considered that patients treated concomitantly with two or more additional antiplatelet or anticoagulant agents (e.g. aspirin acetylsalicylic acid, clopidogrel, heparin, warfarin, acenocoumarol, dabigatran, rivaroxaban or apixaban) should not be treated with cilostazol-containing products.
Maltese: Fid-dawl ta' dan, is-CHMP qies li l-pazjenti kkurati b'mod konkomittanti ma' żewġ aġenti antipjastrini jew antikoagulanti addizzjonali jew iktar (eż. aċidu aċetilsaliċikliku tal-aspirina, ilklopidogrel, l-eparina, il-warfarina, l-akenokoumarol, id-dabigatran, ir-rivaroxaban jew l-apixaban) ma għandhomx jiġu kkurati bi prodotti li fihom il-kilostażolu.
English: In terms of safety, clinical trial data showed that the most commonly-reported adverse events are headaches, diarrhoea, dizziness, palpitations, peripheral oedema and tachycardia, and these adverse events were listed in the product information.
Maltese: F'termini ta' sigurtà, id-dejta tal-provi kliniċi uriet li l-iktar avvenimenti avversi rrapportati b'mod komuni huma uġigħ ta' ras, dijarea, sturdament, palpitazzjonijiet, edema periferika u takikardija, u dawn l-avvenimenti avversi ġew elenkati fit-tagħrif dwar il-prodott.
English: The WMD estimates a mean improvement from baseline for walking distance of 87.4m for cilostazol 100mg bid and 43.7m for placebo (p<0.0001) with a mean baseline walking distance of about 133m (66% improvement with cilostazol).
Maltese: Id-WMD tistima titjib medju mix-xenarju bażi għad-distanza ta' mixi ta' 87.4m tal-kilostażolu 100mg darbtejn kuljum u 43.7m għall-plaċebo (p<0.
English: Cilostazol's effect on absolute walking distances on the treadmill, expressed as an absolute increase over baseline walking distance ranged from +23m to +109m, compared with -2m to +65m for placebo.
Maltese: L-effett tal-kilostażolu fuq id-distanzi ta' mixi assoluti fuq it-tredmil, mogħti bħala żieda assoluta fuq id-distanza ta' mixi tax-xenarju bażi, varja bejn +23m u +109m, meta mqabbel ma' -2m u +65m għall-plaċebo.
English: Considering all available data on the safety and efficacy of cilostazol as well as the conclusions of the ad-hoc expert group meeting, the CHMP has agreed on a number of measures including the restriction of the indication to “second-line use, in patients in whom lifestyle modifications (including stopping smoking and [supervised] exercise programs) and other appropriate interventions have failed to sufficiently improve their intermittent claudication symptoms”, and the introduction of three new contraindications, in patients with history of severe tachyarrhythmia, patients treated concomitantly with two or more additional anti-platelet/anticoagulant agents and patients with unstable angina pectoris, myocardial infarction within the last 6 months, or a coronary intervention in the last 6 months.
Maltese: Wara li titqies id-dejta kollha għad-dispożizzjoni fuq is-sigurtà u l-effikaċja tal-kilostażolu kif ukoll il-konklużjonijiet tal-laqgħa tal-grupp ta' esperti ad-hoc, is-CHMP qabel fuq numru ta' miżuri inkluża r-restrizzjoni tal-indikazzjoni “użu sekondarju, f'pazjenti li modifiki fl-istil tal-ħajja tagħhom (inkluż waqfien mit-tipjip u programmi ta' eżerċizzju [issorveljati]) u interventi xierqa oħrajn naqsu milli jtejbu b'mod suffiċjenti s-sintomi ta' klawdikazzjoni intermittenti tagħhom”, u l-introduzzjoni ta' tliet kontraindikazzjonijiet ġodda, f'pazjenti li fl-imgħoddi kellhom takiarritmija severa, pazjenti kkurati b'żewġ sustanzi kontra l-pjastrini/antikoagulanti jew iktar f'daqqa u pazjenti b'anġina pektoris instabbli, li kellhom infart mijokardijaku tul l-aħħar 6 xhur, jew intervent koronarju flaħħar 6 xhur.
English: Secondary efficacy endpoints included painfree walking distance (initial claudication distance - ICD) measured by treadmill exercise; and Quality of Life assessments.
Maltese: Punti aħħarin sekondarji tal-effikaċja inkludew distanza ta' mixi bla uġigħ (distanza ta' klawdikazzjoni inizjali - ICD) imkejla permezz ta' eżerċizzju fuq tredmil; u valutazzjonijiet tal-Kwalità tal-Ħajja.
English: Cilostazol is a dihydro-quinolinone derivative that belongs to the pharmacotherapeutic group antithrombotic agents, platelet aggregation inhibitor excluding heparin.
Maltese: Is-sustanza kolostażolu hija derivattiv ta' diidro-quinolinone li tappartieni lill-aġenti antitrombotiċi tal-grupp farmakoterapewtiku, inibitur tal-aggregazzjoni tal-pjastrini minbarra eparina.
English: The efficacy of cilostazol has been evaluated in 14 clinical trials which enrolled more than 4000 intermittent claudication (IC) patients.
Maltese: L-effikaċja tal-kilostażolu ġiet evalwata f'14-il prova klinika li rreġistraw iktar minn 4000 pazjent bi klawdikazzjoni intermittenti (IC).
English: The results from clinical trials did not generate any signal of serious cardiac arrhythmic events, but a small number of serious events (ventricular tachycardia, electrocardiogram QT prolongation (including Torsade de Pointes)) were received from spontaneous sources/non-interventional studies and some of these were considered compatible with the chronotropic effects of cilostazol.
Maltese: Ir-riżultati mill-provi kliniċi ma ġġeneraw l-ebda sinjal ta' avvenimenti arritmiċi kardijaċi serji, iżda daħal numru żgħir ta' avvenimenti serji (takikardija ventrukulari, prolungazzjoni tal-QT talelettrokardjogramma (inkluża Torsade de Pointes)) minn sorsi spontanji/studji bla interventi u wħud minn dawn tqiesu kompatibbli mal-effetti kronotropiċi tal-kilostażolu.
English: The primary analysis, pre-specified in the protocols, demonstrated a statistically significant longer walking distance in patients receiving cilostazol 100mg bid over placebo.
Maltese: L-analiżi primarja, speċifikata minn qabel fil-protokolli, uriet distanza ta' mixi statistikament importanti f'pazjenti li kienu qed jirċievu l-kilostażolu 100mg darbtejn kuljum meta mqabbel malplaċebo.
English: No signal for increased mortality was observed in clinical trials, including the CASTLE study.
Maltese: Ma ġie osservat l-ebda sinjal ta' mortalità ogħla filprovi kliniċi, inkluż l-istudju CASTLE.
English: The concerns relating to interactions with other medications (in particular CYP3A4 and CYP2C19 inhibitors) and the possibility of an increased risk for adverse effects have been addressed by the recommendation of a dose reduction to 50mg bid in patients taking concomitant medicines that inhibit these enzymes.
Maltese: It-tħassib relatat malinterazzjonijiet ma' mediċini oħrajn (b'mod partikolari inibituri CYP3A4 u CYP2C19) u l-possibilità ta' riskju ikbar għal effetti avversi ġie indirizzat mir-rakkomandazzjoni ta' tnaqqis tad-doża għal 50mg darbtejn kuljum f'pazjenti li jieħdu mediċini konkomittanti li jinibixxu dawn l-enzimi.
English: The meta-analysis of weighted mean difference (WMD) across the nine trials also demonstrated consistent efficacy of cilostazol across the trials.
Maltese: Il-metanaliżi tad-differenza medja peżata (WMD) fost id-disa' provi wriet ukoll effikaċja konsistenti tal-kilostażolu bejn il-provi.
English: The pharmacovigilance measures should be increased by submitting 6-monthly PSURs including safety reports focused on cardiovascular adverse events, haemorrhagic adverse events and off-label use.
Maltese: Il-miżuri ta' farmakoviġilanza għandhom jiżdiedu billi jiġu sottomessi PSURs ta' 6 xhur inklużi rapporti dawr is-sigurtà ffokati fuq avvenimenti kardjovaskulari avversi, avvenimenti emorraġiċi avversi u użu għal indikazzjoni mhux approvata.
English: Although a post-hoc analysis, the demonstration that the current accepted CV MACE in studies of new drugs (CV death, non-fatal MI and stroke) was statistically significantly lower in the treatment group was felt to give strong reassurance on CV safety.
Maltese: Minkejja analiżi post-hoc, inħass li l-wiri li s-CV MACE attwali aċċettat fl-istudji ta' mediċini ġodda (mewt minn CV, MI mhux fatali u puplesija) kien inqas b'mod statistikament importanti, kien ta' serħan il-moħħ fuq is-sigurtà minn CV.
English: The CHMP also recommended a dose reduction to 50mg bid of cilostazol during concomitant use with such medicines.
Maltese: Is-CHMP irrakkomanda wkoll tnaqqis tad-doża għal 50mg darbtejn kuljum tal-kilostażolu tul użu konkomittanti mat-tali mediċini.
English: The primary endpoint in the nine efficacy trials (called mid-term trials) was maximum walking distance (absolute claudication distance - ACD), measured by exercise treadmill testing.
Maltese: Il-punt aħħari primarju fid-disa' provi kliniċi tal-effikaċja (imsejħa provi ta' terminu medju) kien id-distanza massima ta' mixi (distanza ta' klawdikazzjoni assoluta - ACD), imkejla permezz ta' testijiet ta' eżerċizzju fuq tredmil.
English: The CASTLE study included patients who were treated up to 3 years.
Maltese: L-istudju CASTLE inkluda pazjenti li ġew ikkurati għal massimu ta' 3 snin.
English: The therapeutic indication that has been approved for cilostazol products in Europe is the improvement of the maximal and pain-free walking distances in patients with intermittent claudication (IC), who do not have rest pain and who do not have evidence of peripheral tissue necrosis (peripheral arterial disease (PAD) Fontaine stage II).
Maltese: L-indikazzjoni terapewtika li ġiet approvata għal prodotti tal-kilostażolu hija t-titjib tad-distanzi massimali u bla uġigħ ta' mixi f'pazjenti bi klawdikazzjoni intermittenti (IC), li ma jħossux uġigħ meta jistrieħu u li ma għandhomx evidenza ta' nekrożi tat-tessut periferiku (mard arterjali periferiku (PAD) fl-istadju Fontaine II).
English: The proposal from the MAHs to recommend a reduction to 50mg bid in some patient sub-groups was welcomed by the group.
Maltese: Il-proposta mill-MAHs ta' rakkomandazzjoni ta' tnaqqis għal 50mg darbtejn kuljum f'ċerti sottogruppi ta' pazjenti ntlaqgħet mill-grupp.
English: In order to minimise the risk of drug metabolism interaction, warnings have been introduced in the SmPC and it is now recommended to reduce the dose to 50mg bid in patients taking medicines that inhibit CYP3A4 or 2C19.
Maltese: Biex jiġi minimizzat ir-riskju ta' interazzjoni tal-metaboliżmu tal-mediċina, iddaħħlu twissijiet flSmPC u issa huwa rakkomandat it-tnaqqis tad-doża għal 50mg darbtejn kuljum f'pazjenti li qed jieħdu mediċini li jinibixxu CYP3A4 jew 2C19.
English: Pooled meta-analyses of patient reported outcomes from the short-form health survey (SF-36) and the Walking Impairment Questionnaire (WIQ) demonstrated significant effects of cilostazol over placebo on physical functioning and the physical component score of the SF-36, as well as significant improvements in WIQ speed and distance scores.
Maltese: Ilmetanaliżijiet raggruppati tar-riżultati rrapportati mill-pazjenti mill-istħarriġ sintetizzat dwar issaħħa (SF-36) u l-Kwestonarju dwar l-Indeboliment tal-Mixi (WIQ) urew effetti importanti talkilostażolu apparagun mal-plaċebo fuq il-funzjonament fiżiku u l-punteġġ tal-komponent fiżiku talSF-36, kif ukoll titjib importanti fil-punteġġi tal-veloċità u d-distanza tad-WIQ.
English: However these imbalances involved small numbers of events.
Maltese: Madankollu, dawn l-iżbilanċi involvew numri żgħar ta' avvenimenti.
English: The expert group noted the spontaneous reports of haemorrhage when used with one or two antiplatelet drugs, but were reassured by the absence of evidence from the published placebo-controlled studies.
Maltese: Il-grupp ta' esperti osserva r-rapporti spontanji talemorraġija meta jintuża ma' mediċina kontra l-pjastrini waħda jew tnejn, iżda serrħu rashom minħabba n-nuqqas ta' evidenza mill-istudji kkontrollati bil-plaċebo ppubblikati.
English: The anti-platelet activity of cilostazol also raised a concern for haemorrhagic events.
Maltese: L-attività kontra l-pjastrini tal-kilostażolu qajmet tħassib għal avvenimenti emorraġiċi wkoll.
English: This Article 31 referral was initiated by Spain following review of safety reports received in association with cilostazol during the first 18 months of marketing in Spain (cilostazol was licenced in Spain in 2008).
Maltese: Dan ir-riferiment skont l-Artikolu 31 tnieda minn Spanja wara analiżi tar-rapporti dwar is-sigurtà riċevuti b'rabta mal-kilostażolu tul l-ewwel 18-il xahar ta' kummerċjalizzazzjoni fi Spanja (illkilostażolu ġie liċenzjat fi Spanja fl-2008).