natgillin/translations-raw huggingface dataset:
• if you have a risk of bleeding such as: - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer). 
• če imate tveganje za krvavitev, kot je: - bolezen, zaradi katere ste v nevarnosti za notranjo krvavitev (npr. razjeda na želodcu), - krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitvam v katerokoli tkivo, organ ali sklep v telesu), - nedavna huda poškodba, - nedaven kirurški poseg (vključno z zobozdravstvenimi posegi), - načrtovan kirurški poseg (vključno z zobozdravstvenimi posegi) v naslednjih sedmih dneh,
Cases of Reye's syndrome have occurred following the use of salicylates during varicella infections (see section 4.4). 
Po uporabi salicilatov med okužbo z noricami so poročali o pojavu Reyevega sindroma (glejte poglavje
Hydrogenated castor oil Stearic acid 
Glazura karnauba vosek
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 March 2010 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
DuoPlavin 75 mg/75 mg film-coated tablets clopidogrel/acetylsalicylic acid 
DuoPlavin 75 mg/75 mg filmsko obložene tablete klopidogrel/acetilsalicilna kislina
DuoPlavin 75 mg/100 mg film-coated tablets clopidogrel/acetylsalicylic acid 
DuoPlavin 75 mg/100 mg tablete klopidogrel/acetilsalicilna kislina
Vertigo 
Trombolitiki
Concentrate for solution for 
20 mg/1ml koncentrat za raztopino za
The data submitted by the company are presented below. 
Podatki, ki jih je družba predložila, so predstavljeni spodaj.
On the average the effects appears modest. 
V povprečju je učinek skromen.
The countries involved in the first wave were Austria, Germany, Spain, Finland, Italy, Portugal. 
Države v prvem valu so bile Avstrija, Nemčija, Španija, Finska, Italija in Portugalska.
• The Committee considered the notification of the referral triggered by Sweden under Article 29(4) of Council Directive 2001/83/EC. 
• Odbor je obravnaval napotitveni postopek, ki ga je sprožila Švedska skladno s členom 29(4) Direktive Sveta 2001/83/ES.
Typical syncope episodes are brief and usually last no longer than 20 seconds. 
Tipične epizode sinkope so kratke, običajno ne trajajo več kot 20 sekund.
As an agreement could not be reached the procedure was subsequently referred to CHMP. 
Ker dogovor ni bil dosežen, je bil postopek napoten na CHMP.
The amended labelling and package leaflet of the reference Member State are set out in Annex III. 
Revidirano označevanje in navodilo za uporabo za referenčno državo članico sta na voljo v Prilogi III.
It has been granted marketing authorisation in 25 countries worldwide, including 7 countries in the European Union which were part of a decentralised procedure with Sweden acting as reference Member State. 
Za zdravilo je bilo pridobljeno dovoljenje za promet v 25 državah sveta, vključno s 7 državami v Evropski uniji, ki so bile del decentraliziranega postopka, v katerem je bila Švedska referenčna država članica.
The CHMP having reviewed the above available data on safety noted the following: 
CHMP je po pregledu zgoraj navedenih podatkov o varnosti ugotovil naslednje:
Subsequently, Janssen Cilag submitted an application for mutual recognition of Priligy, 30 mg and 60 mg film-coated tablets in the following Member States: Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, France, Hungary, Ireland, Iceland, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Romania, Slovenia, Slovakia and the United Kingdom. 
Zatem je družba Janssen Cilag predložila vlogo za postopek medsebojnega priznavanja za zdravilo Priligy 30 mg in 60 mg filmsko obložene tablete v naslednjih državah članicah: Belgiji, Bolgariji, na Cipru, v Češki republiki, na Danskem, v Estoniji, Grčiji, Franciji, na Madžarskem, Irskem, Islandiji, v Litvi, Luksemburgu, Latviji, na Malti, Nizozemskem, Norveškem, Poljskem, v Romuniji, Sloveniji, na Slovaškem in v Združenem kraljestvu.
• Safety issues 
• Zadržki glede varnosti
Five of these events were medically confirmed and four events were unconfirmed. 
Pet teh dogodkov je bilo medicinsko potrjenih, štirje pa so bili nepotrjeni.
Overall summary of the scientific evaluation of Priligy and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Priligy in povezana imena (glejte Prilogo I)
Design and dosage 
Zasnova in odmerjanje
The approved indication in the EU is for the treatment of PE in men 18 to 64 years of age. 
Odobrena indikacija v EU je zdravljenje prezgodnje ejakulacije pri moških, starih od 18 do 64 let.
Evidence on the safety profile of Priligy in clinical practice is available from 2 complementary data sources, including 
Dokazi o varnostnem profilu zdravila Priligy v klinični praksi zagotavljata 2 dodatna vira podatkov, vključno s:
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION AND AMENDMENT OF THE LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EUROPEAN MEDICINES AGENCY 
PRILOGA II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE IN DOPOLNILO OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
Overall discussion and benefit/risk assessment 
Končna razprava in vrednotenje koristnih učinkov in tveganja
Those analyses assume that all subjects with missing data, irrespective of the reason for discontinuation, experienced no benefit from treatment with dapoxetine. 
Te analize predpostavljajo, da preiskovanci z manjkajočimi podatki, ne glede na vzrok prekinitve, niso imeli koristi od zdravljenja z dapoksetinom.
All of these events were of short duration and spontaneously resolved. 
Vsi primeri so bili kratkotrajni in so spontano izzveneli.
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). 
Od teh je bila stroga medicinska definicija izgube zavesti izpolnjena pri 8 primerih, vključno z enim sinusnim zastojem (s povezanim 28-sekundnim obdobjem asistole).
Similar results for the geometric mean average IELT at Week 12 were seen in each Phase III study in which IELT was measured. 
Podobne rezultate za geometrično sredino povprečne IELT v 12. tednu so ugotovili v vseh študijah III. faze, v katerih so merili IELT.
The available evidence shows that the risk minimisation measures put in place have been effective in the management of syncope events: 
Razpoložljivi dokazi kažejo, da so uvedeni ukrepi za zmanjšanje tveganja učinkovito obvladali primere sinkope:
Some of the required procedures in the dapoxetine clinical development program (e.g., venipuncture and orthostatic challenge) that may have contributed to the occurrence of syncope are not expected in routine clinical practice. 
Nekaj od postopkov, zahtevanih v kliničnem programu razvoja dapoksetina (npr. venipunkcija in ortostatski izziv) in ki so morda prispevali k pojavu sinkope, se v rutinski klinični praksi ne pričakujejo.
Priligy is a pharmacologic treatment approved for men with Premature Ejaculation (PE). 
Zdravilo Priligy se uporablja za farmakološko zdravljenje in je odobreno za moške s prezgodnjo ejakulacijo (PE).
− No events of syncope have been reported. 
− Primerov sinkope ni bilo prijavljenih.
• 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. 
• 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.
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). 
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).
− 92% of patients were prescribed treatment according to the SmPC, i.e. initiation of treatment with 30 mg. 
− 92 % bolnikov, je bilo predpisano zdravljenje v skladu s povzetkom glavnih značilnosti zdravila, tj. začetek zdravljenja s 30 mg.
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. 
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“.
Syncope occurrence during Post-authorisation 
Pojavnost sinkope v obdobju trženja zdravila
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. 
Ob upoštevanju, da se za podatke IELT ne pričakuje normalna porazdelitev, je kot primernejša povzemajoča statistika namesto povprečja IELT predlagana geometrična sredina IELT.
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. 
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.
Four of these events were associated with the 30 mg dose and the other five were associated with the 60 mg dose. 
Štirje od omenjenih dogodkov so bili povezani z odmerkom 30 mg, preostalih pet pa z odmerkom 60 mg.
The 4 PRO measures reflected inability to control ejaculation, distress related to the timing of ejaculation, satisfaction with sexual intercourse, and relationship difficulty. 
Štirje kazalniki PRO so odražali nesposobnost obvladovanja ejakulacije, stisko zaradi časovne uskladitve ejakulacije, zadovoljstvo s spolnim odnosom in težave v partnerski zvezi.
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. 
Po pojavu redkih primerov sinkope v zgodnjih fazah kliničnega programa razvoja so v III. fazi programa uvedli spremljanje s holterjem.
Half of them were considered as medically confirmed (adjudicated syncope). 
Večina je bila medicinsko potrjenih (obravnavana sinkopa).
During the mutual recognition procedure some Members States considered that the benefit-risk balance for the 60 mg dose was not positive. 
Med postopkom medsebojnega priznavanja so nekatere države članice menile, da razmerje med koristmi in tveganji za odmerek 60 mg ni pozitivno.
The main safety concern was related to the occurrence of syncope in particular for the 60mg strength. 
Glavni varnostni zadržek je bil povezan s pojavnostjo sinkope, zlasti pri jakosti 60 mg.
• Efficacy issues 
• Zadržki glede učinkovitosti
C-2002-014 Multicenter, open-label, 9-month extension study (enrolling subjects from studies C-2002-012 and C-2002-013) 
C-2002-014 Multicentrična, odprta, 9-mesečna podaljšana študija (vključeni preiskovanci iz študij 2002-012 in C-2002-013)
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. 
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.
Number of subjects 
Število preiskovancev
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. 
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.
It can also be concluded that up to about 10% more patients responds to 60 mg compared to 30 mg. 
Lahko se zaključi tudi, da se na odmerek 60 mg odzove približno 10 % več bolnikov.
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). 
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).
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. 
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.
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. 
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.
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. 
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.
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. 
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.
• 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. 
• 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.
These findings suggest that syncope associated with the administration of dapoxetine is vasovagal in etiology. 
Ta odkritja nakazujejo, da je sinkopa, povezana z dajanjem dapoksetina, po etiologiji vazovagalna.
The severity of the adverse events has generally been reported as mild or perhaps moderate, resulting in limited discontinuation from the study by patients. 
Resnost ugotovljenih neželenih učinkov je na splošno blaga oz. morda zmerna, kar je povzročilo malo število prekinitev sodelovanja v študiji.
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). 
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).
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. 
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.
− 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. 
− 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.
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. 
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.
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. 
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.
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. 
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.
• 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. 
• 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.
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. 
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).
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. 
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).
Syncope has been reported in 1 patient taking alternate care/non-Priligy treatment. 
Sinkopo je prijavil 1 bolnik, ki je jemal drugačno zdravljenje/ne zdravila Priligy.
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. 
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.
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) 
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)
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). 
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
Grounds for positive opinion and amendment of the labelling and package leaflet 
Podlaga za pozitivno mnenje in dopolnilo označevanja in navodila za uporabo
• 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. 
• 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.
A statistically significant efficacy difference in favour of 60 mg compared to 30 mg has been established. 
Ugotovljena je bila statistično pomembna razlika v učinkovitosti v prid odmerku 60 mg v primerjavi z odmerkom 30 mg.
Dapoxetine 60 mg: 1774 Dose reduction to 30mg: 194 
Dapoksetin 60 mg: 1774 Zmanjšanje odmerka na 30 mg: 194