FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding the 60 mg strength a more or less pronounced dose-response is observed in all analyses.
Slovenian: Pri jakosti 60 mg so v vseh analizah ugotovili bolj ali manj jasno odvisnost učinka od odmerka.
English: The objecting Member States pointed out that the increase in response noted for the 60mg strength compared to the 30 mg strength in the clinical studies is counteracted by the dose related increase in adverse events, especially the occurrence of syncope associated with loss of consciousness, bradycardia and asystole.
Slovenian: Države članice, ki so vložile ugovor, so izpostavile, da koristi povečanja odziva v kliničnih študijah pri jakosti 60 mg v primerjavi s 30 mg po drugi strani izniči povečanje neželenih učinkov, ki je odvisno od odmerka, zlasti pojavljanje sinkope, povezane z izgubo zavesti, bradikardijo in asistolo.
English: Concerns were raised with regard to the added benefit of the 60 mg strength compared to the 30 mg strength.
Slovenian: Izpostavljeni so bili zadržki v zvezi z dodatno koristjo odmerka jakosti 60 mg v primerjavi z odmerkom 30 mg.
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.
Slovenian: Teh 9 dogodkov se je pojavilo v okviru ocenjene izpostavljenosti med 1 967 483 in 3 934 965 zdravljenj, kar predstavlja ocenjenih 850 000 bolnikov, izpostavljenih od začetka trženja zdravila Priligy do 17. junija 2011.
English: It was also noted that the Phase III studies utilized a fixed-dose design, in which subjects who were randomly assigned to treatment with dapoxetine 60 mg were initiated on a 60-mg dose rather than the 30-mg dose, which is recommended in the Summary of Product Characteristics (SmPC).
Slovenian: Poleg tega so v študijah III. faze uporabljali zasnovo s fiksnim odmerkom, po katerem so preiskovanci, ki so bili naključno razporejeni v zdravljenje z dapoksetinom 60 mg, začeli jemati odmerek 60 mg in ne 30 mg, kot je priporočeno v povzetku glavnih značilnosti zdravila.
English: No event of syncope has been spontaneously reported in association with the administration of Priligy since February 2011.
Slovenian: Od februarja 2011 ni bilo spontano prijavljenega primera sinkope v povezavi z uporabo zdravila Priligy.
English: Therefore, the CHMP was of the opinion that the benefit/risk ratio of Priligy 30 mg and 60 mg filmcoated tablets is considered to be favourable.
Slovenian: Zato je CHMP menil, da je razmerje med koristmi in tveganji za zdravilo Priligy 30 mg in 60 mg filmsko obložene tablete ugodno.
English: After the sponsor implemented risk minimization measures during the course of the two then-ongoing Phase III studies (R096769-PRE-3001 and R096769-PRE-3003), no further episodes of syncope were reported in those studies.
Slovenian: Ko je sponzor med dvema potekajočima študijama III. faze (R096769-PRE-3001 in R096769-PRE-3003) uvedel ukrepe za zmanjšanje tveganja, pojavov sinkope v študijah ni bilo več.
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).
Slovenian: V analizi logaritmiranih podatkov je bila geometrična sredina povprečne IELT v 24. tednu študije R096769-PRE 3001 2,3 minute za dapoksetin 60 mg oz. 1,8 minute za dapoksetin 30 mg (p<0,001) (preglednica 3).
English: The objecting Member States noted that the 60 mg dose yields only mild clinical benefit over the 30 mg dose and asked the MAH to justify that the increase in response for the 60 mg is statistically significant and clinically meaningful.
Slovenian: Države članice, ki so vložile ugovor, so izpostavile, da odmerek 60 mg omogoči le skromno klinično korist v primerjavi z odmerkom 30 mg, in prosile imetnika dovoljenja za promet z zdravilom za utemeljitev, ali je odziv pri odmerku 60 mg statistično ter klinično pomemben.
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.
Slovenian: Redna posodobljena poročila o varnosti zdravila od 17. decembra 2008 do 17. junija 2011 vsebujejo 9 spontano prijavljenih primerov sinkope v obdobju trženja zdravila, pri čemer je 5 primerov medicinsko potrjenih, 4 pa ne.
English: More specifically, among responders to treatment (i.e., those subjects that reported at least a 2category increase in Control Over Ejaculation and at least a 1-category decrease in Personal Distress) in Study R096769-PRE-3001, regarding:
Slovenian: Specifični rezultati med preiskovanci z odzivom na zdravljenje (tj. tistimi preiskovanci, ki so navedli izboljšanje za vsaj 2 kategoriji po lestvici nadzora nad ejakulacijo in za vsaj 1 kategorijo po lestvici osebne stiske) v študiji R096769-PRE-3001 so naslednji:
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.
Slovenian: Vazovagalna sinkopa je prehodna, samoomejena izguba zavesti, okrevanje pa je spontano,
English: This difference was not noted for mean average IELT.
Slovenian: Razlika ni bila opažena pri srednjem povprečnem trajanju intravaginalne ejakulacijske latence (IELT).
English: These events were transient in nature and resolved spontaneously, without any reported accidental injury or long-term sequelae.
Slovenian: Ti dogodki so bili prehodne narave in so izzveneli spontano brez prijavljenih nezgod ali dolgoročnih posledic.
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).
Slovenian: V opravljenih študijah III. faze so ugotovili odvisnost med odmerkom in učinkovitostjo (≥12 % več preiskovancev z odzivom pri odmerku 30 mg kot pri placebu ter dodatnih 5-10 % več preiskovancev z odzivom pri odmerku 60 mg kot pri odmerku 30 mg) ter varnostjo (0,05 % primerov sinkope pri placebu, 0,06 % primerov sinkope pri odmerku 30 mg in 0,23 % primerov sinkope pri odmerku 60 mg).
English: The corresponding placebo-subtracted difference was 35.6% with dapoxetine 60 mg and 26.0% with dapoxetine 30 mg.
Slovenian: Ustrezna razlika v primerjavi s placebom je bila 35,6 % za dapoksetin 60 mg in 26,0 % za dapoksetin 30 mg.
English: More important, there are statistically significantly more responders to 60 mg in different responder analyses, including the primary responder analyses.
Slovenian: Še pomembneje je, da je v različnih analizah, vključno s primarnimi analizami odziva, statistično pomembno več preiskovancev z odzivom na 60-miligramski odmerek.
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.
Slovenian: Vendar pa je bil v različnih analizah preiskovancev z odzivom ugotovljen dosleden vzorec >12 % več preiskovancev z odzivom v skupini, ki je prejemala 30 mg, v primerjavi s placebom ter dodatnih 5-10 % preiskovancev z odzivom v skupini, ki je prejemala 60 mg.
English: The placebo-subtracted percentage difference was 22.1% with dapoxetine 60 mg and 12.8% with dapoxetine 30 mg.
Slovenian: Razlika v primerjavi s placebom je bila 22,1 % za dapoksetin 60 mg in 12,8 % za dapoksetin 30 mg.
English: Ventricular tachycardia (VT) or other serious dysrhythmias were not observed in any of these 7 subjects during the events.
Slovenian: Pri nobenem od 7 preiskovancev med dogodki niso bile zabeležene ventrikularna tahikardija (VT) ali druge nevarne disaritmije.
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%).
Slovenian: Za te resne neželene učinke niso opazili neravnovesja med odmerkoma 30 mg in 60 mg dapoksetina v primerjavi s placebom: placebo 0,9 %; dapoksetin 30 mg po potrebi 0,6 %; in dapoksetin 60 mg po potrebi 0,5 %).
English: Data from this study substantiate that the majority of patients are initiated on dapoxetine at the 30 mg dose, as recommended in the SmPC.
Slovenian: Podatki iz te študije potrjujejo, da se večina bolnikov začne zdraviti z odmerkom 30 mg dapoksetina po priporočilih v povzetku glavnih značilnosti zdravila.
English: They are all included in the 5 PSURs mentioned above.
Slovenian: Vsi so navedeni v zgoraj omenjenih 5 rednih posodobljenih poročilih o varnosti zdravila.
English: Regarding efficacy on the basis of the available data the CHMP concluded that patients receiving Priligy 30 mg and 60 mg showed statistically significant response over patients receiving placebo.
Slovenian: Glede učinkovitosti je na osnovi razpoložljivih podatkov CHMP menil, da so imeli bolniki, ki so prejemali zdravilo Priligy 30 mg in 60 mg, statistično pomembnejšo razliko v odzivu glede na bolnike s placebom.
English: In the analysis of the pooled data for the CGIC (Clinical Global Impression of Change) PRO (Patient Reported Outcome) measure the percentage of subjects reporting the two highest CGIG ratings of “better” or “much better” was 39.0% in the dapoxetine 60 mg group, 30.7% in the dapoxetine 30 mg group and 14.8% in the placebo group at Week 12.
Slovenian: V analizi združenih podatkov za kazalnik CGIC (klinični globalni vtis o spremembi) PRO (izid, o katerem poroča bolnik) je bil v 12. tednu odstotek preiskovancev, ki so navedli dve najvišji oceni CGIG „bolje“ ali „veliko bolje“, 39,0 % v skupini, ki je prejemala dapoksetin 60 mg, 30,7 % v skupini, ki je prejemala dapoksetin 30 mg, ter 14,8 % v skupini, ki je prejemala placebo.
English: Because of that, the MAH conducted exploratory analyses to compare the effect of dapoxetine 60 mg to that of dapoxetine 30 mg.
Slovenian: Zaradi tega je imetnik dovoljenja za promet z zdravilom opravil raziskovalne analize za primerjavo učinka dapoksetina 60 mg in dapoksetina 30 mg.
English: Each of these events was transient in nature and resolved spontaneously, without any reported accidental injury or long-term sequelae.
Slovenian: Vsi dogodki so bili prehodne narave in so izzveneli spontano brez prijavljenih nezgod ali dolgoročnih posledic.
English: On the basis of the available data the CHMP concluded that patients receiving Priligy 30 mg and 60 mg showed statistically significant response over patients receiving placebo.
Slovenian: Na osnovi razpoložljivih podatkov je CHMP menil, da so imeli bolniki, ki so prejemali zdravilo Priligy 30 mg in 60 mg, statistično pomembnejšo razliko v odzivu glede na bolnike, ki so prejemali placebo.
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).
Slovenian: Povprečno trajanje intravaginalne ejakulacijske latence na koncu študij R096769-PRE-3001 in R096769-PRE-3003 za preiskovance z odzivom je bilo skoraj 6 minut v primerjavi s približno 1 minuto v izhodišču ne glede na skupino zdravljenja (preiskovance so naključno razporedili v skupini za zdravljenje s fiksnim odmerkom dapoksetina bodisi 30 mg bodisi 60 mg).
English: Therefore, the CHMP concluded that the benefit-risk of Priligy 30 mg and 60 mg is considered positive.
Slovenian: Zato je CHMP menil, da je razmerje med koristmi in tveganji za zdravilo Priligy 30 mg in 60 mg pozitivno.
English: In this study, no events of “syncope” or “syncope vasovagal” have been reported in any patient prescribed with Priligy.
Slovenian: V tej študiji noben bolnik s predpisanim zdravilom Priligy ni prijavil primera „sinkope“ ali „sinkope, vazovagalne“.
English: • Interim data (4,002 patients treated with Priligy) from the observational post-marketing safety study (R096769-PRE-4001) show:
Slovenian: • Vmesni podatki (4 002 bolnika, zdravljena z zdravilom Priligy) iz opazovalne študije v obdobju trženja zdravila (R096769-PRE-4001) kažejo naslednje:
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.
Slovenian: Pri vseh preiskovancih z izboljšanjem prezgodnje ejakulacije (tj. oceno CGIG vsaj „nekoliko bolje“) je bilo preiskovancev z izboljšanjem v 9.-12. tednu 71,7 % v skupini, ki je prejemala dapoksetin 60 mg, 62,1 % v skupini, ki je prejemala dapoksetin 30 mg, in 36,0 % v skupini, ki je prejemala placebo.
English: One study of 9 weeks duration was also conducted to evaluate the withdrawal effects of dapoxetine 60 mg p.r.n.
Slovenian: Izvedena je bila še ena študija, ki je trajala 9 tednov, za oceno učinkov odtegnitve dapoksetina 60 mg po potrebi in 60 mg enkrat dnevno.
English: Nine events of syncope were reported in the post-approval setting.
Slovenian: V obdobju trženja zdravila je bilo prijavljenih 9 primerov sinkope.
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.
Slovenian: V preglednici 2 je prikazan statistični pomen učinka dapoksetina 60 mg v primerjavi z dapoksetinom 30 mg iz analiz združenih podatkov študij III. faze za ključne parametre učinkovitosti srednje povprečne IELT, mediane povprečne IELT in preiskovančeve ocene CGIC kategorije vsaj „boljše“ in vsaj „nekoliko boljše“.
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.
Slovenian: Za ta kombinirani cilj so z analizo združenih podatkov dokazali, da je bilo v 9.-12. tednu preiskovancev z odzivom 40,2 % v skupini, ki je prejemala dapoksetin 60 mg, 30,8 % v skupini, ki je prejemala dapoksetin 30 mg, in 18,1 % v skupini, ki je prejemala placebo.
English: Therefore, unlike the post-approval setting where all patients initiate treatment with the 30-mg dose of dapoxetine, subjects enrolled into the Phase III studies did not experience the effect of the lower dose first, with the option to increase to the higher dose only if the lower dose was well tolerated.
Slovenian: Zato preiskovanci v študijah III. faze niso bili kot bolniki v obdobju trženja zdravila, ki začnejo zdravljenje z odmerkom 30 mg dapoksetina, in niso najprej prejemali manjšega odmerka z možnostjo prehoda na večji odmerek po dobrem prenašanju manjšega odmerka.
English: Dapoxetine 30 mg: 388 Dapoxetine 60 mg: 389
Slovenian: Dapoksetin 30 mg: 388 Dapoksetin 60 mg: 389
English: Dapoxetine 30 mg: 445 Dapoxetine 60 mg: 445
Slovenian: Dapoksetin 30 mg: 445 Dapoksetin 60 mg: 445
English: Of the most commonly reported dose-dependent adverse events, more than half were reported within the first 4 weeks of the double-blind treatment period of the Phase III studies, and as early as the first dose, and emerged and resolved in a predictable timeframe around the time of anticipated Cmax of dapoxetine (Table 4).
Slovenian: Od najpogosteje ugotovljenih neželenih učinkov, odvisnih od odmerka, je bila več kot polovica prijavljenih v prvih 4 tednih obdobja dvojno zaslepljenega zdravljenja študij III. faze.
English: • spontaneously reported adverse events summarized in 5 Periodic Safety Update Reports (PSURs)
Slovenian: • spontano prijavljenimi neželenimi učinki, povzetimi v 5 rednih posodobljenih poročilih o varnosti zdravila (PSUR) od 17. decembra 2008 do 17. junija 2011,
English: Dapoxetine 30 mg: 354 Dapoxetine 60 mg: 356
Slovenian: Dapoksetin 30 mg: 354 Dapoksetin 60 mg: 356
English: Of the adverse events coding to the MedDRA preferred terms of “syncope” or “syncope vasovagal” (i.e., cases of interest)
Slovenian: Sedem preiskovancev v kliničnem programu razvoja dapoksetina je nosilo holter med nastopom neželenega učinka, ki ima prednostni izraz po MedDRA „sinkopa“ ali „sinkopa, vazovagalna“ (tj. zanimivi primeri).
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).
Slovenian: V študiji spremljanja v obdobju trženja zdravila (R096769-PRE-4001) so prezgodnjo ejakulacijo zdravili pri 4 002 bolnikih z zdravilom Priligy, 1 696 bolnikov pa so zdravili na drugačen način (669 s peroralnim zdravilom).
English: and 60 mg q.d (once daily) as well as another open-label 9-month extension study (see summary table below).
Slovenian: Izvedena je bila še ena 9-mesečna podaljšana študija odprtega tipa (glejte povzetek v spodnji preglednici).
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.
Slovenian: V preglednici 1 je prikazan statistični pomen učinka dapoksetina 60 mg v primerjavi z dapoksetinom 30 mg v 24. tednu študije učinkovitosti in varnosti (R096769-PRE-3001) za ključne parametre učinkovitosti mediane povprečnega trajanja intravaginalne ejakulacijske latence, kombiniranega cilja in preiskovančeve ocene CGIC kategorije vsaj „boljše“ in vsaj „nekoliko boljše“.
English: Dapoxetine 30 mg: 429 Dapoxetine 60 mg: 425
Slovenian: Dapoksetin 30 mg: 429 Dapoksetin 60 mg: 425
English: Sensitivity analyses: Sensitivity analyses were conducted for the key efficacy variables, each representing more conservative assumptions than the originally planned analyses, which included the intent-to-treat (ITT) population with last postbaseline observation carried forward (LPOCF).
Slovenian: Analize so zajemale populacijo z namenom zdravljenja (ITT) z zadnjim naprej prenesenim opažanjem po izhodišču (LPOCF).
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);
Slovenian: • Nadzor nad ejakulacijo: 98,9 % preiskovancev z odzivom je v izhodišču navedlo „zelo slab“ ali „slab“ nadzor, vendar jih je na koncu študije 67,4 % navedlo „dober“ ali „zelo dober“ nadzor, v primerjavi z 78,4 % moških brez prezgodnje ejakulacije, ki so navedli „dober“ ali „zelo dober“ nadzor v opazovalni študiji v EU (R096769-PRE-3004);
English: In the pooled analyses of all Phase III studies significant differences in favour of the 60 mg doses compared to 30 mg were observed for median average IELT, and two out of three PRO measures i.e.
Slovenian: V združenih analizah vseh študij III. faze so bile ugotovljene pomembne razlike med odmerkoma 60 mg in 30 mg za mediano povprečnega IELT in dvema od treh kazalnikov PRO, tj. kombinirani cilj (C2D1) in CGIC vsaj „nekoliko boljši“.
English: • Satisfaction With Sexual Intercourse, 64.4 % of responders reported "very poor" or "poor" satisfaction at baseline but 71.9% reported "good" or "very good" satisfaction at study end, compared with 91.6% of men without PE who reported "good" or "very good" satisfaction in the EU observational study (R096769-PRE-3004);
Slovenian: • Zadovoljstvo s spolnim odnosom: 64,4 % preiskovancev z odzivom je v izhodišču navedlo „zelo majhno“ ali „majhno“ zadovoljstvo, vendar jih je na koncu študije 71,9 % navedlo „veliko“ ali „zelo veliko“ zadovoljstvo, v primerjavi z 91,6 % moških brez prezgodnje ejakulacije, ki so navedli „veliko“ ali „zelo veliko“ zadovoljstvo v opazovalni študiji v EU (R096769-PRE-3004);
English: C-2002-013 Double-blind, randomised, placebo-controlled 12week study evaluating dapoxetine 30 mg and 60 mg p.r.n.
Slovenian: C-2002-013 Dvojno zaslepljena, randomizirana, s placebom nadzorovana 12-tedenska študija ocene dapoksetina 30 mg in 60 mg po potrebi
English: C-2002-012 Double-blind, randomised, placebo-controlled 12week study evaluating dapoxetine 30 mg and 60 mg p.r.n.
Slovenian: C-2002-012 Dvojno zaslepljena, randomizirana, s placebom nadzorovana 12-tedenska študija ocene dapoksetina 30 mg in 60 mg po potrebi
English: • Personal Distress, 77.9% of responders reported "extremely" or "quite a bit" of distress at baseline but 80.1% reported "not at all" or "a little bit" of distress at study end, compared with 91.9% of men without PE who reported "not at all" or "a little bit" of distress in the EU observational study (R096769-PRE-3004);
Slovenian: • Osebna stiska: 77,9 % preiskovancev z odzivom je v izhodišču navedlo „izjemno“ ali „precejšnjo“ stisko, vendar jih je na koncu študije 80,1 % navedlo, da so bili „brez“ oziroma so imeli „majhno“ stisko, v primerjavi z 91,9 % moških brez prezgodnje ejakulacije, ki so navedli, da so bili„brez“ oziroma so imeli "majhno" stisko v opazovalni študiji v EU (R096769-PRE
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).
Slovenian: • Težave v partnerski zvezi: 33,7 % preiskovancev z odzivom je v izhodišču navedlo „izjemne“ ali „precejšnje“ težave v partnerski zvezi, vendar jih je na koncu študije 79,1 % navedlo, da so „brez“ oziroma imajo „majhne“ težave, v primerjavi z 98,4 % moških brez prezgodnje ejakulacije, ki so navedli, da so „brez“ oziroma imajo „majhne“ težave v opazovalni študiji v EU (R096769-PRE-3004).
English: Double-blind, randomised, placebo-controlled 24week study evaluating dapoxetine 30 mg and 60 mg p.r.n.
Slovenian: Dvojno zaslepljena, randomizirana, s placebom nadzorovana 24-tedenska študija ocene dapoksetina 30 mg in 60 mg po potrebi
English: Double-blind, randomised, placebo-controlled 9week study evaluating dapoxetine 60 mg p.r.n.
Slovenian: Dvojno zaslepljena, randomizirana, s placebom nadzorovana 9-tedenska študija ocene dapoksetina 60 mg po potrebi in 60 mg enkrat dnevno
English: Double-blind, randomised, placebo-controlled 12week study evaluating dapoxetine 30 mg and 60 mg p.r.n.
Slovenian: Dvojno zaslepljena, randomizirana, s placebom nadzorovana 12-tedenska študija ocene dapoksetina 30 mg in 60 mg po potrebi
English: In conclusion, a non-negligible improvement can be achieved with 60 mg for some patients with insufficient response to 30 mg.
Slovenian: Torej, pri nekaterih bolnikih z nezadostnim odzivom na odmerek 30 mg lahko dosežemo nezanemarljivo izboljšanje z odmerkom 60 mg. Potencialno povečanje tveganja za sinkopo je dokazano obvladljivo z uvedenimi ukrepi za zmanjšanje tveganja.
English: Efficacy and safety were documented in four Phase III studies of 12-24 weeks duration comparing dapoxetine 30 mg p.r.n and 60 mg p.r.n with placebo.
Slovenian: Učinkovitost in varnost so dokumentirali v štirih študijah III. faze, ki so trajale 12-24 tednov.
English: London, 22 January 2009 Doc.
Slovenian: London, 22. januarja 2009 Sklic dok.
English: International non-proprietary name (INN): paliperidone
Slovenian: Mednarodno nelastniško ime (INN): paliperidon