FrancophonIA/ELRC3.0 huggingface dataset:
English: − No events of syncope have been reported.
Slovenian: − Primerov sinkope ni bilo prijavljenih.
English: • Some of the risk minimisation measures (e.g. patient instructions, exclusion of orthostatic manoeuvres) were introduced already during the course of Phase III program with no further episodes of syncope reported in the clinical program following that.
Slovenian: • Nekatere ukrepe za zmanjšanje tveganja (npr. navodila bolnikom, izključitev ortostatskih manevrov) so uvedli že v med programom III. faze, in v nadaljevanju v kliničnem programu ni bilo prijavljenih epizod sinkop.
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).
Slovenian: Ti vključujejo številne varnostne zadržke - povezane z antidepresivi SSRI, ki so v prometu - kot so pojav samomorilnosti po začetku zdravljenja, klinično pomembni neželeni učinki na razpoloženje (vključno z depresijo in tesnobo), akatizija, sindrom prekinitve jemanja SSRI, neželeni učinki na spolnost, ki so bili merjeni s splošno sprejetimi in validiranimi lestvicami, vključno z lestvico za oceno depresije po Montgomeryju-Asbergu (Montgomery-Asberg Depression Rating Scale, MADRS) in lestvico za oceno depresije po Becku (Beck Depression Inventory-II, BDI-II) (razpoloženje), Hamiltonovo lestvico za oceno tesnobnosti (Hamilton Anxiety Scale, HAM-A) (tesnoba), Barnesovo lestvico za oceno akatizije (Barnes Akathisia Scale, BARS) (akatizija), lestvico znakov in simptomov odtegnitvenega sindroma (Discontinuation-emergent signs and symptoms, DESS) (odtegnitveni sindrom) in mednarodnim indeksom erektilne funkcije (International Index of Erectile Function, IIEF) (učinki na spolnost) oz. metodami merjenja samomorilnosti v skladu s klasifikacijskim algoritmom za oceno samomorilnosti Univerze Columbia (Columbia Classification Algorithm of Suicide Assessment [C-CASA] za samomorilnost).
English: − 92% of patients were prescribed treatment according to the SmPC, i.e. initiation of treatment with 30 mg.
Slovenian: − 92 % bolnikov, je bilo predpisano zdravljenje v skladu s povzetkom glavnih značilnosti zdravila, tj. začetek zdravljenja s 30 mg.
English: Seventeen patients in the study have reported a serious adverse event (11 patients taking Priligy, 6 patients taking alternate care/non Priligy), all of which were considered to be “not related to treatment” by the treating health care provider.
Slovenian: Resen neželeni učinek je prijavilo 17 bolnikov (11 bolnikov, ki jemljejo zdravilo Priligy, 6 bolnikov, ki prejemajo drugačno zdravljenje/ne zdravila Priligy), pri vseh je lečeči zdravnik ocenil, da „ni povezan z zdravljenjem“.
English: Syncope occurrence during Post-authorisation
Slovenian: Pojavnost sinkope v obdobju trženja zdravila
English: Given that IELT data is not expected to be normally distributed, the geometric mean IELT has been proposed as a more appropriate summary statistic than the mean IELT.
Slovenian: Ob upoštevanju, da se za podatke IELT ne pričakuje normalna porazdelitev, je kot primernejša povzemajoča statistika namesto povprečja IELT predlagana geometrična sredina IELT.
English: It is acknowledged that these results are conservative estimates obtained with the Baseline Observation Carried Forward (BOCF) approach for imputation of missing values, i. e. subjects discontinuing prior to end of study are counted as non-responders.
Slovenian: Priznava se, da so ti rezultati konzervativne ocene, dobljene s pristopom naprej prenesenega izhodiščnega opažanja (BOCF) za vnos manjkajočih vrednosti, tj. preiskovanci, ki so prekinili sodelovanje pred koncem študije, se štejejo za neodzivne.
English: Four of these events were associated with the 30 mg dose and the other five were associated with the 60 mg dose.
Slovenian: Štirje od omenjenih dogodkov so bili povezani z odmerkom 30 mg, preostalih pet pa z odmerkom 60 mg.
English: The 4 PRO measures reflected inability to control ejaculation, distress related to the timing of ejaculation, satisfaction with sexual intercourse, and relationship difficulty.
Slovenian: Štirje kazalniki PRO so odražali nesposobnost obvladovanja ejakulacije, stisko zaradi časovne uskladitve ejakulacije, zadovoljstvo s spolnim odnosom in težave v partnerski zvezi.
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.
Slovenian: Po pojavu redkih primerov sinkope v zgodnjih fazah kliničnega programa razvoja so v III. fazi programa uvedli spremljanje s holterjem.
English: Half of them were considered as medically confirmed (adjudicated syncope).
Slovenian: Večina je bila medicinsko potrjenih (obravnavana sinkopa).
English: During the mutual recognition procedure some Members States considered that the benefit-risk balance for the 60 mg dose was not positive.
Slovenian: Med postopkom medsebojnega priznavanja so nekatere države članice menile, da razmerje med koristmi in tveganji za odmerek 60 mg ni pozitivno.
English: The main safety concern was related to the occurrence of syncope in particular for the 60mg strength.
Slovenian: Glavni varnostni zadržek je bil povezan s pojavnostjo sinkope, zlasti pri jakosti 60 mg.
English: • Efficacy issues
Slovenian: • Zadržki glede učinkovitosti
English: C-2002-014 Multicenter, open-label, 9-month extension study (enrolling subjects from studies C-2002-012 and C-2002-013)
Slovenian: C-2002-014 Multicentrična, odprta, 9-mesečna podaljšana študija (vključeni preiskovanci iz študij 2002-012 in C-2002-013)
English: The CHMP issued a positive opinion recommending the granting of the marketing authorisation for Priligy 30mg and 60 mg film-coated tablets for which the summary of product characteristics remains as per the final version achieved during the Coordination group procedure.
Slovenian: CHMP je izdal pozitivno mnenje s priporočilom za odobritev dovoljenja za promet z zdravilom Priligy 30 mg in 60 mg filmsko obložene tablete, za katerega povzetek glavnih značilnosti zdravila ostaja kot v končni različici, pripravljeni med postopkom usklajevalne skupine.
English: Number of subjects
Slovenian: Število preiskovancev
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.
Slovenian: Zdravilna učinkovina v zdravilu Priligy je dapoksetinijev hidroklorid, ki spada v skupino selektivnih zaviralcev ponovnega privzema serotonina (SSRI) in je bil prvotno razvit kot potencialno zdravilo proti bolečinam, debelosti in depresiji.
English: It can also be concluded that up to about 10% more patients responds to 60 mg compared to 30 mg.
Slovenian: Lahko se zaključi tudi, da se na odmerek 60 mg odzove približno 10 % več bolnikov.
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).
Slovenian: Od 6 081 preiskovancev, naključno razporejenih v zdravljenje v okviru študije III. faze, so pri 41 preiskovancih ugotovili resne neželene učinke (25 preiskovancev so zdravili z dapoksetinom, 16 pa jih je prejelo placebo).
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.
Slovenian: Ta zaključek je dodatno potrdila odsotnost primerov sinkope v študiji varnosti v obdobju trženja zdravila ter ocenjena izpostavljenost 850 000 bolnikov v obdobju trženja z le 5 medicinsko potrjenimi spontanimi prijavami sinkope, ki so bile kratkotrajne in so spontano izzvenele.
English: However the median and the geometric mean are more appropriate measures of central tendency for IELT, and for these endpoints highly significant differences between 30 and 60 mg were obtained.
Slovenian: Vendar sta mediana in geometrična sredina primernejši merili težnje IELT k sredini in pri omenjenih ciljih so bile opažene zelo pomembne razlike med 30- in 60-miligramskim odmerkom.
English: Thus, although a statistically significant result was not observed in every analysis it must be concluded from the overall pattern that a statistically significant efficacy difference between 30 and 60 mg has been established.
Slovenian: Čeprav statistično pomembnih rezultatov niso odkrili v nobeni analizi, je treba iz splošnega vzorca zaključiti, da je ugotovljena statistično pomembna razlika v učinkovitosti med odmerkoma 30 in 60 mg.
English: All events of syncope observed in the Phase III clinical development program summarized in the MAA occurred before implementation of activities intended to minimize the occurrence of syncope, including the administration of patient instructions and the exclusion of orthostatic manoeuvres from the study designs, suggesting that syncope could be managed through patient and clinician instruction/education.
Slovenian: Vsi dogodki sinkope, ugotovljeni v III. fazi kliničnega programa razvoja in povzeti v vlogi za pridobitev dovoljenja za promet z zdravilom, so se pojavili pred uvedbo aktivnosti za zmanjšanje pojavnosti sinkope, vključno z navodilom bolnikom in izključevanjem ortostatskih manevrov iz zasnov študij, kar kaže, da se lahko sinkopa obravnava v okviru svetovanja/usposabljanja, ki poteka med bolnikom in zdravnikom.
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.
Slovenian: • Izpostavljenost v obdobju trženja zdravila je ocenjena na 850 000 bolnikov, od katerih je bilo spontano prijavljenih le 9 primerov sinkope, od teh je bilo 5 medicinsko potrjenih, 4 pa ne.
English: These findings suggest that syncope associated with the administration of dapoxetine is vasovagal in etiology.
Slovenian: Ta odkritja nakazujejo, da je sinkopa, povezana z dajanjem dapoksetina, po etiologiji vazovagalna.
English: The severity of the adverse events has generally been reported as mild or perhaps moderate, resulting in limited discontinuation from the study by patients.
Slovenian: Resnost ugotovljenih neželenih učinkov je na splošno blaga oz. morda zmerna, kar je povzročilo malo število prekinitev sodelovanja v študiji.
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).
Slovenian: Študije III. faze so bile prvotno zasnovane za primerjavo učinka dapoksetina 30 in 60 mg s placebom in ne med seboj (tj. 30 mg v primerjavi s 60 mg).
English: Based on data collected to date, responses to the survey questions indicated that the majority (>98%) of patients who received the Patient Brochure and PIL understood the content and felt that the information regarding Priligy dosing, Priligy safety, and PE was adequate.
Slovenian: Doslej zbrani odgovori na anketna vprašanja kažejo, da je večina (>98 %) bolnikov, ki so prejeli brošuro za bolnike in navodilo za uporabo, razumela vsebino in je mnenja, da so informacije o odmerjanju, varnosti zdravila Priligy in prezgodnji ejakulaciji zadostne.
English: − More than 98% of the patients prescribed Priligy found that the Patient Brochure and PIL were understandable, and felt that the information regarding Priligy dosing and Priligy safety was helpful.
Slovenian: − Več kot 98 % bolnikov s predpisanim zdravilom Priligy je menilo, da sta brošura za bolnike in navodilo za uporabo razumljiva in da so informacije o odmerjanju in varnosti zdravila Priligy koristne.
English: All analyses for all endpoints confirmed the treatment benefit of dapoxetine when subjects who discontinued early, had no postbaseline data, or had no postbaseline data at Week 9-12 were considered as non-responders.
Slovenian: Vse analize za vse cilje so potrdile korist zdravljenja z dapoksetinom, če se preiskovanci, ki so prekinili sodelovanje prezgodaj in preiskovanci brez podatkov po 9.-12. tednu, štejejo za neodzivne preiskovance.
English: However, the initially observed excess risk for syncope with the 60 mg was found manageable with the risk minimisation measures introduced during the phase III program.
Slovenian: Vendar je bilo ugotovljeno, da je v začetku opaženo odvečno tveganje sinkope pri odmerku 60 mg obvladljivo z ukrepi za zmanjšanje tveganja, uvedenimi v program III. faze.
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.
Slovenian: V zvezi z varnostjo so bili glavni neželeni učinki, ugotovljeni med kliničnimi preskušanji, navzea, driska, omotica, glavobol, nespečnost in utrujenost, ki so tipični za skupino zdravil SSRI.
English: • The Committee reviewed all available data submitted by the marketing authorisation holder on the safety of Priligy in particular for the 60 mg film-coated tablets and the reported cases of syncope.
Slovenian: • Odbor je pregledal vse razpoložljive podatke o varnosti, ki jih je predložil imetnik dovoljenja za promet z zdravilom Priligy, zlasti za 60 mg filmsko obložene tablete in prijavljene primere sinkope.
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.
Slovenian: Med študijami dapoksetina III. faze je spremljanje s holterjem zaznalo bradikardijo in asistole, povezane s pojavom sinkope (vključno z 1 primerom asistole, ki je trajala 28 sekund).
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.
Slovenian: Na podlagi poročil o zakasnjeni ejakulaciji pri bolnikih, ki so prejemali dapoksetin za zdravljenje poglavitne depresivne motnje, ter profila hitrega delovanja in izločanja so učinkovino kasneje razvijali kot zdravilo za prezgodnjo ejakulacijo, ki se jemlje po potrebi (p.r.n).
English: Syncope has been reported in 1 patient taking alternate care/non-Priligy treatment.
Slovenian: Sinkopo je prijavil 1 bolnik, ki je jemal drugačno zdravljenje/ne zdravila Priligy.
English: In the Phase III studies, the treatment benefit was measured in subjects who met the prespecified composite endpoint requiring functional benefit (i.e., improved control over ejaculation) as well as emotional benefit (i.e., decreased levels of distress) related to the latency of their ejaculation.
Slovenian: V študijah III. faze so korist zdravljenja merili pri preiskovancih, ki so izpolnili vnaprej opredeljen kombiniran cilj z zahtevano funkcionalno koristjo (tj. boljši nadzor nad ejakulacijo) ter čustveno koristjo (tj. zmanjšana stiska) v povezavi z latenco ejakulacije.
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)
Slovenian: Preglednica 4: Neželeni učinki (≥2 %), povezani z zdravljenjem, z nastopom v 4. tednu s placebom kontrolirane študije III. faze (Dapoksetin SCS: nabor za analizo preiskovancev z namenom zdravljenja)
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).
Slovenian: Porazdelitev odzivov na te kazalnike PRO pri moških, ki so dosegli kombinirani cilj, so primerjali s porazdelitvijo pri moških brez prezgodnje ejakulacije, ki so sodelovali v opazovalni študiji v EU (R096769-PRE
English: Grounds for positive opinion and amendment of the labelling and package leaflet
Slovenian: Podlaga za pozitivno mnenje in dopolnilo označevanja in navodila za uporabo
English: • The Committee considered that a non-negligible improvement can be achieved with the 60 mg strength for some patients with insufficient response to the 30 mg strength and that the potentially increased risk for syncope has been proven manageable with the adequate risk minimization measures.
Slovenian: • Odbor je menil, da pri nekaterih bolnikih z nezadostnim odzivom na jakost 30 mg lahko dosežemo nezanemarljivo izboljšanje z jakostjo 60 mg in da je potencialno povečanje tveganja za sinkopo dokazano obvladljivo z uvedenimi ukrepi za zmanjšanje tveganja.
English: A statistically significant efficacy difference in favour of 60 mg compared to 30 mg has been established.
Slovenian: Ugotovljena je bila statistično pomembna razlika v učinkovitosti v prid odmerku 60 mg v primerjavi z odmerkom 30 mg.
English: Dapoxetine 60 mg: 1774 Dose reduction to 30mg: 194
Slovenian: Dapoksetin 60 mg: 1774 Zmanjšanje odmerka na 30 mg: 194
English: • The Committee reviewed all available data submitted by the marketing authorisation holder, in particular to support the efficacy of Priligy 60 mg film-coated tablets versus Priligy 30 mg filmcoated tablets.
Slovenian: • Odbor je pregledal vse razpoložljive podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, zlasti v podporo učinkovitosti zdravila Priligy 60 mg filmsko obložene tablete v primerjavi z zdravilom Priligy 30 mg filmsko obložene tablete.
English: Considering that PE is not a life-threatening disease, the added benefit of 60 mg compared to 30 mg (5-10% more responders) was considered too modest to outweigh the potentially increased risk for severe cases of syncope.
Slovenian: Ob upoštevanju, da prezgodnja ejakulacija ni življenjsko ogrožajoča bolezen, štejejo dodatno korist odmerka 60 mg v primerjavi s 30 mg (510 % več oseb z odzivom) za preskromno, da bi odtehtala potencialno povečano tveganje hudih primerov sinkope.
English: The most important study for the European target population (R096769-PRE-3001) failed to demonstrate statistical significance for the primary endpoint (mean average IELT) in the comparison of the 30 and 60 mg doses.
Slovenian: V najpomembnejši študiji za evropsko ciljno populacijo (R096769-PRE-3001) niso dokazali statistične pomembnosti primarnega cilja (geometrična sredina povprečne IELT) v primerjavah 30-miligramskega in 60-miligramskega odmerka.
English: With regard to the added benefits of the 60mg strength, the mean (or median) difference in IELT between the 30 and 60 mg dose appears marginal.
Slovenian: Kar zadeva dodatne koristi jakosti 60 mg, je povprečna razlika (ali mediana) v IELT med odmerkom 30 in 60 mg postranskega pomena.
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.
Slovenian: Večina neželenih učinkov v kliničnih študijah III. faze (vključno z navzeo, drisko, omotico, glavobolom, nespečnostjo in utrujenostjo, ki so značilne za skupino zdravil SSRI) je bilo na splošno akutne simptomatike in prehodne narave, blage do zmerne resnosti, kratkotrajnih in časovno odvisnih od odmerjanja.
English: Although the Phase III studies were not intended to detect a statistically significant difference between the 30 mg and 60 mg dose, a dose response was observed in all studies for all endpoints.
Slovenian: Čeprav študije III. faze niso bile zasnovane za odkrivanje statistično pomembne razlike med odmerkoma 30 mg in 60 mg, so za cilj vseh študij ugotovili odvisnost odziva od odmerka.
English: However, in conservative responder analyses based on IELT data as well as on patient and partner reported outcome measures an additional 5-10% responders to 60 mg compared to 30 mg.
Slovenian: Vendar pa je v konzervativnih analizah preiskovancev z odzivom na osnovi podatkov o IELT ter kazalnikih izida, poročanih s strani bolnika oz. partnerice, še 5-10 % več pri prejemnikih odmerka 60 mg v primerjavi s prejemniki odmerka 30 mg.
English: • data from a large post-marketing safety surveillance study (R096769-PRE-4001).
Slovenian: • podatki iz velike študije spremljanja v obdobju trženja zdravila (R096769-PRE-4001).
English: Patients who were prescribed with Priligy in study R096769-PRE-4001 were given a survey at the last observational visit to provide feedback on the understandability and helpfulness of the Priligy Patient Brochure and/or Patient Information Leaflet (PIL).
Slovenian: Bolniki s predpisanim zdravilom Priligy v študiji R096769-PRE-4001 so na zadnjem kontrolnem obisku prejeli anketo za povratne informacije o razumljivosti in koristnosti brošure za zdravilo Priligy za bolnike oz. o navodilu za uporabo.
English: The key efficacy endpoints were Intravaginal Ejaculation Latency Time (IELT) and percentage of responders based on Control Over Ejaculation and Personal Distress (at least a 2-category increase in Control Over Ejaculation and at least a 1-category decrease in Personal Distress).
Slovenian: Ključna merila učinkovitosti so bila trajanje intravaginalne ejakulacijske latence (IELT), odstotek preiskovancev z odzivom po lestvici nadzora nad ejakulacijo in lestvici esebne stiske (povečanje vsaj za 2 kategoriji po lestvici aadzora nad ejakulacijo in za 1 kategorijo po lestvici osebne stiske).
English: With additional wording in the Product Information it was concluded and agreed in the initial decentralised procedure that benefit-risk was positive for the 60 mg dose.
Slovenian: Z dodatkom besedila v navodilo za uporabo je bilo v prvotnem decentraliziranem postopku sklenjeno in dogovorjeno, da je razmerje med koristmi in tveganji za odmerek 60 mg pozitivno.
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.
Slovenian: Priporočilo za titracijo odmerka v povzetku glavnih značilnosti zdravila je namenjeno zmanjšanju tveganja pri tistih bolnikih, ki so izpostavljeni 60 mg dapoksetina, da bi v rutinski klinični praksi zmanjšali možnost hudih neželenih učinkov, vključno s sinkopo.
English: A total of 30 syncope cases (cases of interest) were observed during the clinical studies.
Slovenian: Med kliničnimi študijami so ugotovili skupno 30 primerov sinkope (zanimivi primeri).
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.
Slovenian: Upoštevati je treba, da so se 3 od 6 primerov sinkope z izgubo zavesti po odmerku 60 mg zgodili v študiji R096769-PRE-3002, v kateri so vsi preiskovanci izvajali ortostatske manevre, hkrati pa primerjava samo skupine s 60 mg in skupine s placebom, ki sta bili randomizirani v razmerju 4:1, potencialno vnese napako v škodo odmerku 60 mg.
English: It was concluded that Priligy 30 mg shows greater efficacy versus placebo.
Slovenian: Šteje se, da je zdravilo Priligy 30 mg učinkovitejše od placeba.