FrancophonIA/ELRC3.0 huggingface dataset:
English: These include many of the safety concerns associated with marketed antidepressant SSRIs, such as treatment-emergent suicidality, clinically important moodrelated adverse events (including depression and anxiety), akathisia, SSRI discontinuation syndrome, and sexual function adverse effects, which were measured using broadly accepted and validated rating scales, including the Montgomery-Asberg Depression Rating Scale (MADRS) and Beck Depression Inventory-II (BDI-II) (mood), Hamilton Anxiety Scale (HAM-A) (anxiety), Barnes Akathisia Scale (BARS) (akathisia), discontinuation-emergent signs and symptoms (DESS) (withdrawal syndrome), and International Index of Erectile Function (IIEF) (sexual function effects) and methods (Columbia Classification Algorithm of Suicide Assessment [C-CASA] for suicidality).
Maltese: SSRIs fis-suq, bħal suwiċidali ta emerġenti mill-kura, avvenimenti avversi klinikament importati relatati mal-burdata (inkluż dipressjoni u anzjetà), akatiżja, sindromu tat-twaqqif tal-SSRI, u avvenimenti avversi tal-funzjoni sesswali, li tkejlu permezz ta' skali ta' klassifikazzjoni vvalidati u aċċettati b'mod wiesa, inkluż l-Iskala ta' Klassifikazzjoni tad-Dipressjoni Montgomery-Asberg (MADRS) u l-Inventarju tad-Dipressjoni Beck-II (BDI-II) (burdata), l-Iskala tal-Ansjetà Hamilton (HAM-A) (ansjetà), l-Iskala tal-Akatiżja Barnes (BARS) (akatiżja), sinjali u sintomi emerġenti mit-twaqqif (DESS) (sindromu tal-irtirar), u l-Indiċi Internazzjonali tal-Funzjoni Erettili (IIEF) (effetti tal-funzjoni sesswali) u metodi (Algoritmu ta' Klassifikazzjoni ta' Valutazzjoni ta' Suwiċidju Kolumbja [C-CASA] għas-suwiċidalità).
English: Evidence on the safety profile of Priligy in clinical practice is available from 2 complementary data sources, including
Maltese: Evidenza dwar il-profil ta' sigurtà ta' Priligy fil-prattika klinika hija disponibbli minn 2 sorsi kumplimentari ta' data, inkluż
English: Typical syncope episodes are brief and usually last no longer than 20 seconds.
Maltese: Episodji tipiċi ta' sinkope huma qosra u normalment ma jdumux aktar minn 20 sekonda.
English: Placebo: 245
Maltese: Plaċebo: 245
English: Placebo: 430
Maltese: Plaċebo: 430
English: • data from a large post-marketing safety surveillance study (R096769-PRE-4001).
Maltese: • dejta minn studju kbir ta' sorveljanza wara t-tqegħid fis-suq (R096769-PRE-4001).
English: • The Committee considered the notification of the referral triggered by Sweden under Article 29(4) of Council Directive 2001/83/EC.
Maltese: • Il-Kumitat ikkunsidra n-notifika tar-referenza attivata mill-Isvezja skont l-Artikolu 29(4) tadDirettiva tal-Kunsill 2001/83/KE.
English: Placebo: 440
Maltese: Plaċebo: 440
English: The approved indication in the EU is for the treatment of PE in men 18 to 64 years of age.
Maltese: L-indikazzjoni approvata fl-UE hija għall-kura ta' PE fl-irġiel ta' bejn it-18 u l64 sena.
English: Nine spontaneously reported events of syncope in the post-approval setting are included in the PSURs summarizing safety from 17 December 2008 to 17 June 2011, of which 5 events are medically confirmed and 4 events are unconfirmed.
Maltese: Disa' avvenimenti ta' sinkope rrapportati b'mod spontanju wara l-approvazzjoni ġew inklużi filPSURs li jagħtu sommarju tas-sigurtà mis-17 ta' Diċembru 2008 sas-17 ta' Ġunju 2011, li minnhom 5 avvenimenti ġew medikament ikkonfermati u 4 avvenimenti ma ġewx ikkonfermati.
English: Design and dosage
Maltese: Disinn u dożaġġ
English: The majority of adverse events reported in Phase III clinical studies, (including nausea, diarrhoea, dizziness, headache, insomnia, and fatigue, which are typical of the SSRI class of drugs), were generally acute symptomatic events that were typically self-limited, mild or moderate in severity, brief in duration, and temporally related to dosing.
Maltese: Il-maġġoranza tal-avvenimenti avversi rrapportati fl-istudji kliniċi tal-Fażi III, (inkluż nawseja, dijarea, sturdament, uġigħ ta' ras, insomnija, u għejja, li huma tipiċi tal-klassi ta' mediċini SSRI), kienu ġeneralment avvenimenti akuti sintomatiċi li tipikament kienu awto-limitanti, ħfief jew moderati fis-severità, ta' dewmien qasir, u temporanjament relatati mad-dożaġġ.
English: In the analysis of logtransformed data, the geometric mean average IELT at Week 24 in Study R096769-PRE-3001 was 2.3 minutes for dapoxetine 60 mg and 1.8 minutes for dapoxetine 30 mg (p<0.001) (Table 3).
Maltese: Fl-analiżi tad-dejta trasformata f'logaritmi, il-medja ġeometrika tal-IELT fil-Ġimgħa 24 flIstudju R096769-PRE-3001 kienet ta' 2.3 minuti għal dapoxetine 60 mg u ta' 1.8 minuti għal dapoxetine 30 mg (p<0.001) (Tabella 3).
English: C-2002-014 Multicenter, open-label, 9-month extension study (enrolling subjects from studies C-2002-012 and C-2002-013)
Maltese: Studju ta' estensjoni, multi-ċentriku, b'tikketta miftuħa, fuq 9-xhur (li fih ħadu sehem suġġetti mill-istudji C-2002-012 u C-2002-013)
English: • Against a background of a post-marketing exposure estimated to 850,000 patients only 9 events of syncope have been spontaneously reported, 5 of which are medically confirmed and 4 of which are unconfirmed.
Maltese: • Fi sfond ta' espożizzjoni wara t-tqegħid fis-suq stmata għal 850,000 pazjent kien hemm biss 9 avvenimenti ta' sinkope rrapportati b'mod spontanju, li 5 minnhom huma medikament ikkonfermati u 4 li mhumiex ikkonfermati.
English: During the Phase III studies of dapoxetine, Holter monitoring detected bradycardia and asystole (including 1 case of 28-second asystole) associated with the occurrence of syncope.
Maltese: Matul l-istudji tal-Fażi III ta' dapoxetine, il-monitoraġġ Holter innota bradikardija u asystole (inkluż każ wieħed ta' asystole ta' 28-sekonda) assoċjat mal-okkorrenza ta' sinkope.
English: The placebo-subtracted percentage difference was 22.1% with dapoxetine 60 mg and 12.8% with dapoxetine 30 mg.
Maltese: Id-differenza fil-perċentwal bil-plaċebo mnaqqas kienet ta' 22.1% b'dapoxetine 60 mg u ta' 12.8% b'dapoxetine 30 mg.
English: It was concluded that Priligy 30 mg shows greater efficacy versus placebo.
Maltese: Ġie konkluż li Priligy 30 mg juri effikaċja akbar kontra plaċebo.
English: For these serious adverse events no imbalance between the 30 mg and 60-mg doses of dapoxetine relative to placebo was obsereved: placebo, 0.9%; dapoxetine 30 mg p.r.n., 0.6%; and dapoxetine 60 mg p.r.n., 0.5%).
Maltese: Għal dawk l-avvenimenti avversi serji ma kienx osservat żbilanċ bejn id-dożi ta' dapoxetine ta' 30 mg u ta' 60 mg fir-rigward tal-plaċebo: plaċebo, 0.9%; dapoxetine 30 mg p.r.n., 0.6%; u dapoxetine 60 mg p.r.n., 0.5%).
English: • Interim data (4,002 patients treated with Priligy) from the observational post-marketing safety study (R096769-PRE-4001) show:
Maltese: • Dejta interim (4,002 pazjenti li rċevew kura bi Priligy) mill-istudju ta' osservazzjoni dwar issigurtà wara t-tqegħid fis-suq (R096769-PRE-4001) turi:
English: Of the adverse events coding to the MedDRA preferred terms of “syncope” or “syncope vasovagal” (i.e., cases of interest)
Maltese: Fost l-avvenimenti avversi kodifikati skont it-termini preferuti tal-MedDRA ta' “sinkope” jew
English: A statistically significant efficacy difference in favour of 60 mg compared to 30 mg has been established.
Maltese: Ġiet stabbilita differenza statistikament sinifikanti fl-effikaċja favur id-doża ta' 60 mg meta mqabbla mad-doża ta' 30 mg.
English: • spontaneously reported adverse events summarized in 5 Periodic Safety Update Reports (PSURs)
Maltese: • avvenimenti avversi irrapportati b'mod spontanju miġbura fil-qosor f'5 Rapporti Perjodiċi ta'
English: The dose-titration recommendation in the SmPC is intended to mitigate the risk to those patients who are exposed to the 60 mg dose of dapoxetine and thereby reduce the possibility that a patient may experience more severe adverse events, including syncope, in routine clinical practice.
Maltese: It-titrazzjoni tad-doża rrakkomandata fl-SmPC hija maħsuba biex tnaqqas ir-riskju għal dawk il-pazjenti li huma esposti għad-doża ta' dapoxetine ta' 60 mg u b'hekk tnaqqas il-possibbiltà li pazjent jista' jesperjenza aktar avvenimenti avversi severi, inkluż sinkope, fil-prattika klinika ta' rutina.
English: − 92% of patients were prescribed treatment according to the SmPC, i.e. initiation of treatment with 30 mg.
Maltese: − 92% tal-pazjenti ġew preskritti kura skont l-SmPC, jiġifieri l-bidu ta' kura bi 30 mg.
English: A total of 30 syncope cases (cases of interest) were observed during the clinical studies.
Maltese: Kienu osservati total ta' 30 każ ta' sinkope (każijiet ta' interess) matul l-studji kliniċi.
English: Of the 6,081 subjects randomly assigned to treatment in the Phase III studies, 41 subjects reported serious adverse events (25 subjects were treated with dapoxetine, 16 subjects received placebo).
Maltese: Mis-6,081 suġġett assenjati b'mod aleatorju għall-kura fl-istudji tal-Fażi III, 41 suġġett irrapportaw avvenimenti avversi serji (25 suġġett kienu rċevew kura bi dapoxetine, 16-il suġġett kienu rċevew plaċebo).
English: In the Phase III studies that were conducted, a dose-response was observed with respect to efficacy (≥ 12% more responders on 30 mg compared to placebo and an additional 5-10% responders on 60 mg compared to 30 mg) as well as safety (0.05, 0.06 and 0.23% cases of syncope with loss of consciousness for placebo, 30 mg and 60 mg, respectively).
Maltese: Fl-istudji tal-Fażi III li saru, ġie osservat rispons għad-doża fir-rigward tal-effikaċja (≥ 12% aktar ta' dawk li rrispondew għal 30 mg meta mqabbla ma' plaċebo u 5-10% addizzjonali ta' dawk li rrispondew għal 60 mg meta mqabbla ma' 30 mg) kif ukoll tas-sigurtà (0.05, 0.06 u 0.23% ta' każijiet ta' sinkope b'telf ta' konoxxenza għal plaċebo, 30 mg u 60 mg, rispettivament).
English: Regarding safety the main events reported during clinical trials were nausea, diarrhoea, dizziness, headache, insomnia, and fatigue, which are typical of the SSRI class of drugs.
Maltese: Fir-rigward tas-sigurtà, l-avvenimenti ewlenin irrapportati matul il-provi kliniċi kienu nawseja, dijarea, sturdament, uġigħ ta' ras, insomnija, u għejja, li huma tipiċi tal-klassi ta' mediċini SSRI.
English: Of these the strict medical definition requiring loss of consciousness was fulfilled for 8 cases, including one case with sinus arrest (with an associated 28-second period of asystole).
Maltese: Fost dawn id-definizzjoni medika stretta li teħtieġ telf ta' konoxxenza kienet sodisfatta fi 8 każijiet, inkluż każ wieħed b'arrest tas-sinus (b'asystole assoċjat fuq perjodu ta' 28 sekonda).
English: The available evidence shows that the risk minimisation measures put in place have been effective in the management of syncope events:
Maltese: L-evidenza disponibbli turi li l-miżuri għall-minimizzazzjoni tar-riskju stabbiliti kienu effettivi flimmaniġġjar tal-avvenimenti ta' sinkope:
English: The corresponding placebo-subtracted difference was 35.6% with dapoxetine 60 mg and 26.0% with dapoxetine 30 mg.
Maltese: Id-differenza korrispondenti bil-plaċebo mnaqqas kienet ta' 35.6% b'dapoxetine 60 mg u ta' 26.
English: The 9 events occurred in the context of an estimated exposure between 1,967,483 and 3,934,965 treatment courses, representing an estimated 850,000 patients exposed from the time that Priligy became commercially available to 17 June 2011.
Maltese: Id-9 avvenimenti seħħew fil-kuntest ta' espożizzjoni stmata bejn il-korsijiet ta' kura 1,967,483 u 3,934,965, li jirrappreżentaw madwar 850,000 pazjent esposti minn meta Priligy kien sar kummerċjalment disponibbli sas-17 ta' Ġunju 2011.
English: reported across the dapoxetine clinical development program, 7 subjects were wearing a Holter monitor at the time of the syncopal event.
Maltese: “sinkope vasovagali” (jiġifieri, każijiet ta' interess) rapportati matul il-programm ta' żvilupp kliniku ta' dapoxetine, 7 suġġetti kienu liebsin monitor Holter fil-ħin tal-avveniment sincopali.
English: Dapoxetine 60 mg: 1774 Dose reduction to 30mg: 194
Maltese: Dapoxetine 60 mg: 1774
English: The active substance of Priligy is dapoxetine hydrochloride that belongs to the class of selective serotonin reuptake inhibitors (SSRIs), originally developed as a potential treatment of pain, obesity and depression.
Maltese: Is-sustanza attiva ta' Priligy hija dapoxetine hydrochloride li tagħmel parti mill-klassi ta' inibituri selettivi ta' ġbir mill-ġdid ta' serotonin (SSRIs), oriġinarjament żviluppata bħala kura potenzjali ta' uġigħ, obeżità u dipressjoni.
English: The mean average IELT at study end for responders in studies R096769-PRE-3001 and R096769-PRE-3003 approached 6 minutes compared to approximately 1 minute at baseline irrespective of treatment group (subjects were randomly assigned to fixed-dose treatment with either dapoxetine 30 mg or 60 mg).
Maltese: L-IELT medju fit-tmiem tal-istudju għal dawk li rrispondew flistudji R096769-PRE-3001 u R096769-PRE-3003 qarreb is-6 minuti meta mqabbel ma' madwar minuta 1 fil-linja bażi irrispettivament mill-grupp ta' kura (is-suġġetti kienu assenjati b'mod aleatorju għal kura b'doża fissa b'jew dapoxetine 30 mg jew 60 mg).
English: For all subjects with improvement in their PE condition (i.e. CGIC rating of at least “slightly better”) the percentage of subjects that reported an improvement at Week 9-12 was 71.7% for dapoxetine 60 mg, 62.1% for dapoxetine 30 mg and 36.0% in the placebo group.
Maltese: Għas-suġġetti kollha li kellhom titjib fil-kundizzjoni tal-PE tagħhom (jiġifieri klassifikazzjoni ta' CGIC ta' mill-anqas “ftit aħjar”), il-perċentwal ta' suġġetti li rrapportaw titjib filĠimgħa 9-12 kien ta' 71.7% għal dapoxetine 60 mg, 62.1% għal dapoxetine 30 mg u 36.0% għallgrupp tal-plaċebo.
English: For this composite endpoint, the analysis of the pooled dataset demonstrated that the percentage of subjects who were responders in the dapoxetine 60 mg group was 40.2% versus 30.8% in the 30 mg group and 18.1% in those receiving placebo at Week 9-12.
Maltese: Għal dan il-punt ta' tmiem kompost, l-analiżi tas-sett ta' dejta miġbura wriet li l-perċentwal ta' suġġetti li kienu dawk li rrispondew fil-grupp ta' dapoxetine 60 mg kien ta' 40.2% kontra 30.8% filgrupp ta' 30 mg u 18.1% f'dawk li kienu qegħdin jirċievu plaċebo bejn Ġimgħa 9-12.
English: : 491 Dapoxetine 60 mg q.d.
Maltese: Dapoxetine 60 mg p.r.n.: 491 Dapoxetine 60 mg q.d.:
English: In the analyses of the pooled Phase III study data, the statistical significance of the effect for dapoxetine 60 mg compared to dapoxetine 30 mg for the key efficacy parameters of mean average IELT, median average IELT, and both subject-rated CGIC measure thresholds of at least "better" and at least "slightly better" can be observed in Table 2.
Maltese: Fl-analiżi tad-dejta miġbura tal-istudju tal-Fażi III, is-sinifikat statistiku tal-effett għal dapoxetine 60 mg meta mqabbel ma' dapoxetine 30 mg għall-parametri ewlenin ta' effikaċja talIELT medju, l-IELT medju medjan, u ż-żewġ CGIC ikklassifikati mis-suġġetti jkejlu limiti ta' millinqas "aħjar" u mill-inqas "ftit aħjar" jistgħu jiġu osservati fit-Tabella 2.
English: C-2002-012 Double-blind, randomised, placebo-controlled 12week study evaluating dapoxetine 30 mg and 60 mg p.r.n.
Maltese: C-2002-012 Studju bi blindaġġ doppju, randomizzat, ikkontrollat bi plaċebo fuq 12-il ġimgħa li evalwa dapoxetine 30 mg u 60 mg p.r.n.
English: C-2002-013 Double-blind, randomised, placebo-controlled 12week study evaluating dapoxetine 30 mg and 60 mg p.r.n.
Maltese: C-2002-013 Studju bi blindaġġ doppju, randomizzat, ikkontrollat bi plaċebo fuq 12-il ġimgħa li evalwa dapoxetine 30 mg u 60 mg p.r.n.
English: The countries involved in the first wave were Austria, Germany, Spain, Finland, Italy, Portugal.
Maltese: Il-pajjiżi nvoluti fl-ewwel mewġa kienu l-Awstrija, il-Ġermanja, Spanja, il-Finlandja, lItalja, il-Portugall.
English: • Interpersonal Difficulty, 33.7% of responders reported "extremely" or "quite a bit" of interpersonal difficulty at baseline but 79.1% reported "not at all" or "a little bit" of interpersonal difficulty at study end, compared with 98.4% of men without PE who reported "not at all" or "a little bit" of interpersonal difficulty in the EU observational study (R096769-PRE-3004).
Maltese: • Diffikultà Interpersonali, 33.7% ta' dawk li rrispondew irrapportaw diffikultà interpersonali "estrema" jew "pjuttost gravi" fil-linja bażi iżda 79.1% irrapportaw "lanqas xejn" jew "ftit biss" ta' diffikultà interpersonali fit-tmiem tal-istudju, meta mqabbla ma' 98.4% tal-irġiel mingħajr PE li rrapportaw "lanqas xejn" jew "ftit biss" ta' diffikultà interpersonali fl-istudju ta' osservazzjoni tal-UE (R096769-PRE-3004).
English: Following reports of ejaculatory delay in patients taking dapoxetine for major depressive disorder and based on the rapid onset and elimination profile of the substance it was later developed as a PE treatment on an as needed (p.r.n) basis.
Maltese: Wara rapporti ta' dewmien fl-ejakulazzjoni f'pazjenti li kienu qegħdin jieħdu dapoxetine għal disturb dipressiv maġġuri u abbażi tal-bidu rapidu u l-profil ta' eliminazzjoni tas-sustanza aktar tard ġie żviluppat bħala kura għall-PE fuq bażi ta' ħtieġa (p.r.n).
English: Table 4: Treatment-Emergent Adverse Events (≥2%) With Onset Days Within 4 Weeks on the Study in Phase III Placebo-Controlled Studies (Dapoxetine SCS: Intent-to-Treat Analysis Set)
Maltese: Tabella 4: Avvenimenti Avversi li Ħarġu mill-Kura (≥2%) Bi Ġranet Ta' Bidu Fi Żmien 4
English: It can also be concluded that up to about 10% more patients responds to 60 mg compared to 30 mg.
Maltese: Jista' jiġi konkluż ukoll li sa 10% aktar ta' pazjenti jirrispondu għal 60 mg meta mqabbla ma' 30 mg.
English: However, in different responder analyses there is a consistent pattern of >12% more responders on 30 mg compared to placebo and an additional 5-10% more responders on 60 mg.
Maltese: Madankollu, fl-analiżi differenti ta' dawk li rrispondew hemm mudell konsistenti ta' >12% aktar ta' rispons fuq id-doża ta' 30 mg meta mqabbla ma' plaċebo u żieda ta' 5-10% aktar ta' rispons għal 60 mg.
English: Vasovagal syncope represents a transient, self-limited loss of consciousness, from which subsequent recovery is spontaneous, complete, and usually prompt, without reported serious associated injury.
Maltese: Is-sinkope vasovagali jirrappreżenta telfien temporanju fl-għarfien, awto-limitanti, li minnu l-irkupru sussegwenti huwa spontanju, komplet, u normalment fil-pront, mingħajr rapporti ta' dannu serju assoċjat.
English: It should be noted that 3 of the 6 cases of syncope with loss of consciousness on 60 mg occurred in Study R096769-PRE-3002 in which all subjects underwent orthostatic manoeuvres, and comparing only 60 mg and placebo randomised in a 4:1 ratio, potentially introducing a bias against the 60 mg dose.
Maltese: Għandu jiġi nnotat li 3 mis-6 każijiet ta' sinkope li kellhom telf ta' għarfien fuq id-doża ta' 60 mg seħħew fl-Istudju R096769-PRE-3002 li fih is-suġġetti kollha għaddew minn manuvri ortostatiċi, u li qabbel biss id-doża ta' 60 mg u plaċebo randomizzati fi proporzjon ta' 4:1, li potenzjalment introduċa preġudizzju kontra d-doża ta' 60 mg.
English: This conclusion has been further strengthen with no cases of syncope in the postmarketing safety study and an estimated post-marketing exposure of 850,000 patients with only 5 medically confirmed spontaneous reports of syncope, all of short duration and spontaneously resolved.
Maltese: Din il-konklużjoni ġiet imsaħħa ulterjorment bin-nuqqas ta' każijiet ta' sinkope fl-istudju dwar is-sigurtà wara t-tqegħid fis-suq u l-espożizzjoni stmata ta' wara t-tqegħid fis-suq ta' 850,000 pazjent b'biss 5 rapporti spontanji medikament ikkonfermati ta' sinkope, li kollha kienu ta' dewmien qasir u rriżolvew b'mod spontanju.
English: • Control Over Ejaculation, 98.9% of responders reported "very poor" or "poor" control at baseline but 67.4% reported "good" or "very good" control at study end, compared with 78.4% of men without PE who reported "good" or "very good" control in the EU observational study (R096769PRE-3004);
Maltese: • Kontroll Fuq l-Eġakulazzjoni, 98.9% ta' dawk li rrispondew irrapportaw kontroll "baxx ħafna" jew "baxx" fil-linja bażi iżda 67.4% irrapportaw kontroll "tajjeb" jew "tajjeb ħafna" fit-tmiem tal-istudju, meta mqabbla ma' 78.4% tal-irġiel mingħajr PE li rrapportaw kontroll "tajjeb" jew "tajjeb ħafna" fl-istudju ta' osservazzjoni tal-UE (R096769-PRE-3004);
English: efficacy and safety study (R096769-PRE-3001), the statistical significance of the effect for dapoxetine 60 mg compared to dapoxetine 30 mg for the key efficacy parameters of median average IELT, the composite endpoint, and the subject-rated CGIC measure thresholds of at least "better" and at least "slightly better" can be observed in Table 1.
Maltese: Fl-24-il Ġimgħa fl-istudju tal-U.E. dwar l-effikaċja u s-sigurtà (R096769-PRE-3001), is-sinifikat statistiku tal-effett għal dapoxetine 60 mg meta mqabbel ma' dapoxetine 30 mg għall-parametri ewlenin ta' effikaċja tal-medja medjana tal-IELT, il-punt ta' tmiem kompost, u l-CGIC ikklassifikat mis-suġġett ikejlu limiti ta' mill-inqas "aħjar" u mill-inqas "ftit aħjar" jistgħu jiġu osservati fitTabella 1.
English: More important, there are statistically significantly more responders to 60 mg in different responder analyses, including the primary responder analyses.
Maltese: Aktar importanti, fl-analiżi differenti ta' dawk li rrispondew, inkluż fl-analiżi primarji ta' dawk li rrispondew hemm aktar rispons statistikament sinifikanti għal 60 mg.
English: − No events of syncope have been reported.
Maltese: − L-ebda avvenimenti ta' sinkope ma ġew irrapportati.
English: Half of them were considered as medically confirmed (adjudicated syncope).
Maltese: Nofshom kienu kkunsidrati bħala medikament ikkonfermati (sinkope aġġudikata).
English: The distribution of responses to these PRO measures in men who met the composite endpoint was compared to that of men without PE who participated in the EU Observational study (R096769-PRE-3004).
Maltese: Id-distribuzzjoni tarrisposti għal dawn il-miżuri tal-PRO fl-irġiel li ssodisfaw il-punt ta' tmiem kompost tqabblet ma' dik tal-irġiel mingħajr PE li pparteċipaw fl-istudju ta' Osservazzjoni tal-UE (R096769-PRE-3004).
English: In the post-marketing safety surveillance study (R096769-PRE-4001) 4,002 patients have been treated with Priligy and 1,696 patients have been treated with an alternate form of treatment (669 of which were treated with oral medication) for PE as of the data cut-off of 30 June 2011, representing data collected over approximately 24 months since regulatory approval through the Decentralized Procedure (DCP).
Maltese: Fl-istudju ta' sorveljanza tas-sigurtà wara t-tqegħid fis-suq (R096769-PRE-4001) 4,002 pazjenti rċevew kura bi Priligy u 1,696 pazjent irċevew kura b'forma alternattiva ta' kura (li minnhom 669 rċevew kura b'mediċina orali) għall-PE mid-data tal-għeluq tat-30 ta' Ġunju 2011, li jirrappreżentaw dejta miġbura fuq madwar 24 xahar mill-approvazzjoni regolatorja permezz talProċedura Deċentralizzata (DCP). Dejta minn dan l-istudju tissostanzja li l-maġġoranza ta' pazjenti jinbdew fuq dapoxetine fid-doża ta' 30 mg, kif irrakkomandat fl-SmPC.
English: The Phase III studies were originally designed to compare the effect of dapoxetine 30 and 60 mg to that of placebo, and not to each other (i.e., 30 mg versus 60 mg).
Maltese: L-istudji tal-Fażi III kienu oriġinarjament iddisinjati biex iqabblu l-effett ta' dapoxetine 30 u 60 mg ma' dawk tal-plaċebo, u mhux ma' xulxin (jiġifieri, 30 mg kontra 60 mg).
English: After occurrence of infrequent cases of syncope in the early phases of the clinical development program Holter monitoring was introduced in the phase III program.
Maltese: L-avvenimenti kollha ta' sinkope osservati fil-programm ta' żvilupp kliniku tal-Fażi
English: Nine events of syncope were reported in the post-approval setting.
Maltese: Ġew irrapportati disa' avvenimenti ta' sinkope wara l-approvazzjoni.
English: The potentially increased risk for syncope has been proven manageable with the risk minimization measures put in place.
Maltese: Ġie ppruvat li l-potenzjal ta' żieda fir-riskju għal sinkope huwa maniġġevoli permezz tal-miżuri għall-minimizzazzjoni tar-riskju stabbiliti.