FrancophonIA/ELRC3.0 huggingface dataset:
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Croatian: Podaci iz kliničkih ispitivanja pokazali su povećani rizik od samoubilačkog ponašanja u odraslih osoba u dobi manjoj od 25 godina s psihijatrijskim stanjima koji su bili liječeni antidepresivima.
English: - The review of a signal for anaphylactic reaction reported a total of 40 post-marketing cases, including seven where causality with vortioxetine treatment was considered possible.
Croatian: - Ocjenom signala anafilaktičke reakcije utvrđeno je ukupno 40 slučajeva prijavljenih u razdoblju nakon stavljanja lijeka u promet, uključujući i sedam slučajeva u kojima se uzročno-posljedična veza s liječenjem vortioksetinom smatra mogućom.
English: On the basis of the scientific conclusions for vortioxetine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vortioxetine is unchanged subject to the proposed changes to the product information.
Croatian: Na temelju znanstvenih zaključaka za vortioksetin, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) vortioksetin nepromijenjen, uz predložene izmjene informacija o lijeku.
English: When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Brintellix may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish.
Croatian: Kada se uzimaju tijekom trudnoće, osobito u posljednja 3 mjeseca trudnoće, lijekovi poput Brintellixa mogu kod djeteta povećati rizik od ozbiljnog stanja koje se zove perzistentna plućna hipertenzija kod novorođenčadi (PPHN), koje prouzročuje ubrzano disanje i plavičastu kožu.
English: Brintellix has been shown to reduce the broad range of depressive symptoms, including sadness, inner tension (feeling anxious), sleep disturbances (reduced sleep), reduced appetite, difficulty in concentrating, feelings of worthlessness, loss of interest in favourite activities, feeling of being slowed down.
Croatian: Pokazalo se da Brintellix smanjuje široki raspon depresivnih simptoma, uključujući tugu, unutarnju napetost (osjećaj tjeskobe), smetnje spavanja (smanjeno spavanje), smanjeni apetit, otežanu koncentraciju, osjećaj bezvrijednosti, gubitak interesa za omiljene aktivnosti, osjećaj usporenosti ili usporenost.
English: Very common: may affect more than 1 in 10 people - nausea
Croatian: Vrlo često: može se javiti u više od 1 na 10 osoba - mučnina
English: In CYP2D6 ultra-rapid metabolisers, the plasma concentration of vortioxetine 10 mg/day were between those obtained in extensive metabolisers at 5 mg/day and 10 mg/day.
Croatian: Kod vrlo brzih metabolizatora CYP2D6, koncentracija vortioksetina u plazmi pri 10 mg dnevno je bila između onih dobivenih kod opsežnih metabolizatora pri 5 mg dnevno i pri 10 mg dnevno.
English: In accordance with the half-life, the accumulation index is 5 to 6 based on AUC0-24h following multiple doses of 5 to 20 mg/day.
Croatian: Sukladno poluvremenu, indeks nakupljanja je 5 do 6 na temelju AUC0-24h nakon višekratnih doza od 5 do 20 mg/dan.
English: In vitro, vortioxetine did not show any relevant potential for inhibition or induction of cytochrome P450 isozymes (see section 5.2).
Croatian: In vitro, vortioksetin nije pokazao nikakav relevantni potencijal za inhibiciju ili indukciju izoenzima citokroma P450 (vidjeti dio 5.2).
English: Vortioxetine-related material was distributed to the milk of lactating rats (see section 4.6).
Croatian: Tvari povezane s vortioksetinom distribuirane su u mlijeko štakora u laktaciji (vidjeti dio 4.6).
English: The effect seen with vortioxetine was a 4.7 point difference to placebo in MADRS total score at Week 8 (MMRM analysis).
Croatian: Opaženi učinak vortioksetina je bio 4,7 bodova razlike u odnosu na placebo u ukupnom rezultatu na MADRS u 8. tjednu (MMRM analiza).
English: The dose may be increased by your doctor to a maximum of 20 mg vortioxetine per day or lowered to a minimum of 5 mg vortioxetine per day depending on your response to treatment.
Croatian: Vaš liječnik može povećati dozu na najviše 20 mg vortioksetina na dan ili smanjiti na najmanje 5 mg vortioksetina na dan, ovisno o Vašem odgovoru na liječenje.
English: This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Croatian: Ovaj lijek sadrži male količine etanola (alkohola), manje od 100 mg po dozi.
English: Vortioxetine was superior (p=0.004) to placebo on the primary outcome measure, the time to relapse of MDD, with a hazard ratio of 2.0; that is, the risk of relapse was two times higher in the placebo group than in the vortioxetine group.
Croatian: Vortioksetin je bio superioran (p=0,004) placebu u mjeri primarnog ishoda, vremenu do relapsa MDD-a, s omjerom rizika od 2,0; odnosno, rizik od relapsa bio je dva puta veći u placebo skupini, nego u skupini koja je primala vortioksetin.
English: Serotonergic medicinal products
Croatian: Serotonergički lijekovi
English: In general, the observed side effects were mild to moderate and occurred within the first two weeks of treatment.
Croatian: Općenito, opažene nuspojave bile su blage do umjerene te su se javile unutar prvih dvaju tjedana liječenja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA SREDNJEG PAKIRANJA / SASTAVNICA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Reversible, non-selective MAOI (linezolid)
Croatian: Reverzibilni, neselektivni MAOI (linezolid)
English: - are 65 years of age or older.
Croatian: ≥ 65 godina.
English: The efficacy of vortioxetine was demonstrated with at least one dosage group across 9 of the 12 studies, showing at least a 2-point difference to placebo in the Montgomery and Åsberg Depression Rating Scale (MADRS) or Hamilton Depression Rating Scale 24-item (HAM-D24) total score.
Croatian: Djelotvornost vortioksetina je pokazana u najmanje jednoj doznoj skupini kroz 9 od 12 ispitivanja, iskazujući najmanje 2 boda razlike od placeba na Montgomery i Åsberg ljestvici za mjerenje depresije (MADRS) ili Hamilton ljestvici za mjerenje depresije s 24-stavke (HAM-D24) u ukupnom rezultatu.
English: Vortioxetine should be used with caution in patients with a history of mania/hypomania and should be discontinued in any patient entering a manic phase.
Croatian: Vortioksetin treba primjenjivati s oprezom u bolesnika s anamnezom manije/hipomanije te liječenje treba prekinuti u svakog bolesnika koji ulazi u maničnu fazu.
English: Common: may affect up to 1 in 10 people - diarrhoea, constipation, vomiting - dizziness - itching of the whole body - abnormal dreams
Croatian: Često: mogu se javiti u do 1 na 10 osoba - proljev, zatvor, povraćanje - omaglica - svrbež cijelog tijela - neuobičajeni snovi
English: Caution should be exercised in patients at risk, such as the elderly, patients with cirrhosis of the liver or patients concomitantly treated with medicinal products known to cause hyponatraemia.
Croatian: Potreban je oprez u rizičnih bolesnika, kao što su stariji, bolesnici s cirozom jetre ili bolesnici istodobno liječeni lijekovima za koje je poznato da prouzročuju hiponatremiju.
English: EXP {MM-YYYY} When opened, use within 8 weeks
Croatian: ROK VALJANOSTI Rok valjanosti {MM-GGGG} Po otvaranju, upotrijebiti unutar 8 tjedana
English: Please tell your doctor if you are taking any of the medicines above, since your doctor needs to know if you already are at risk for seizures.
Croatian: Molimo obavijestite svog liječnika ako uzimate bilo koji od gore navedenih lijekova, budući da potrebno da Vaš liječnik zna da li već imate rizik za napadaje.
English: The incidence of self-reported adverse sexual reactions was low and similar to placebo in clinical short- and long-term studies with vortioxetine.
Croatian: Incidencija samoprijavljenih spolnih nuspojava bila je niska te slična onoj s placebom u kratkoročnim i dugoročnim kliničkim ispitivanjima s vortioksetinom.
English: Bleeding abnormalities, such as ecchymoses, purpura and other haemorrhagic events, such as gastrointestinal or gynaecological bleeding, have been reported rarely with the use of antidepressants with serotonergic effect, including vortioxetine .
Croatian: Abnormalnosti povezane s krvarenjem kao što su ekhimoze, purpura i drugi hemoragijski događaji, poput gastrointestinalnog ili ginekološkog krvarenja su rijetko prijavljene uz primjenu antidepresiva sa serotonergičkim učinkom, uključujući vortioksetin.
English: Diarrhoea, Constipation, Vomiting
Croatian: Proljev, konstipacija, povraćanje
English: If you stop taking Brintellix
Croatian: Ako prestanete uzimati Brintellix
English: Make sure your midwife and/or doctor know you are on Brintellix.
Croatian: Obvezno recite Vašoj primalji i/ili liječniku da uzimate Brintellix.
English: Brintellix is used to treat major depressive episodes in adults.
Croatian: Brintellix se koristi za liječenje velikih depresivnih epizoda u odraslih osoba.
English: Component of a multipack, can't be sold separately.
Croatian: Sastavnica višestrukog pakiranja se ne može prodavati zasebno.
English: Following dosages several fold higher than the therapeutic dose range, events of seizure and serotonin syndrome have been reported.
Croatian: Nakon doza nekoliko puta većih od raspona terapijske doze, prijavljeni su događaji napadaja i serotoninskog sindroma.
English: Discontinuation of vortioxetine should be considered in patients with symptomatic hyponatraemia and appropriate medical intervention should be instituted.
Croatian: Treba razmotriti prekid liječenja vortioksetinom u bolesnika sa simptomatskom hiponatremijom te započeti odgovarajuću medicinsku intervenciju.
English: After first opening the drops should be used within 8 weeks.
Croatian: Nakon otvaranja upotrijebiti unutar 8 tjedana.
English: The maintenance of antidepressant efficacy was demonstrated in a relapse-prevention study.
Croatian: Održavanje antidepresivne djelotvornosti pokazano je u ispitivanju prevencije relapsa.
English: Due to the risk of serotonin syndrome, vortioxetine is contraindicated in any combination with irreversible non-selective MAOIs.
Croatian: Zbog rizika od serotoninskog sindroma vortioksetin je kontraindiciran u svakoj kombinaciji s ireverzibilnim neselektivnim MAOI-ma.
English: - Based upon the role of serotonin on haemostasis, the mechanism of action of vortioxetine and 63 post-marketing cases retrieved from a signal for haemorrhage with possible causality with vortioxetine, it was considered that haemorrhage should be included as an adverse drug reaction in the product information of vortioxetine.
Croatian: Na temelju uloge serotonina u hemostazi, mehanizma djelovanja vortioksetina i 63 slučaja iz razdoblja nakon stavljanja lijeka u promet, prikupljena u sklopu signala krvarenja, s mogućom uzročnom povezanošću s vortioksetinom, smatra se da krvarenje treba biti navedeno kao nuspojava u informacijama o lijeku za vortioksetin.
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Croatian: Nuspojave su navedene ispod koristeći se sljedećom konvencijom: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Following multiple dosing of 5, 10, or 20 mg/day, mean Cmax values of 9 to 33 ng/mL were observed.
Croatian: Nakon višekratnog doziranja od 5, 10 ili 20 mg/dan, opažena je srednja vrijednost Cmax od 9 do 33 ng/mL.
English: The efficacy of vortioxetine is supported by the pooled responder analysis, in which the proportion of responders ranged from 46% to 49% for vortioxetine versus 34% for placebo (p <0.01; NRI analysis).
Croatian: Djelotvornost vortioksetina je podržana objedinjenom analizom onih koji su odgovorili na liječenje u kojoj je udio onih koji su odgovorili bio u rasponu od 46% do 49% za vortioksetin u usporedbi s 34% za placebo (p < 0,01; NRI analiza).
English: Human case reports with medicinal products from the related pharmacological class of antidepressants (SSRIs) have shown an effect on sperm quality that is reversible.
Croatian: Prikazi slučajeva u ljudi o lijekovima iz srodne farmakološke skupine antidepresiva (SSRI-i) su pokazali reverzibilni učinak na kakvoću sperme.
English: A meta-analysis of placebo-controlled clinical studies of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 years old.
Croatian: Meta analiza placebom kontroliranih kliničkih ispitivanja antidepresiva u odraslih bolesnika s psihijatrijskim poremećajima pokazala je povećani rizik od suicidalnog ponašanja s antidepresivima u usporedbi s placebom u bolesnika mlađih od 25 godina.
English: Brintellix is indicated for the treatment of major depressive episodes in adults.
Croatian: Brintellix je indiciran za liječenje velikih depresivnih epizoda u odraslih.
English: If this happens to your baby, you should contact your midwife and/or doctor immediately.
Croatian: Ako se to dogodi Vašem djetetu, odmah se obratite svojoj primalji i/ili liječniku.
English: Vortioxetine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI.
Croatian: Liječenje vortioksetinom se ne smije započeti najmanje 14 dana nakon prekida liječenja ireverzibilnim neselektivnim MAOI-ma.
English: - carbamazepine, phenytoin (medicines to treat epilepsy or other illness).
Croatian: - karbamazepin, fenitoin (lijekovi za liječenje epilepsije i drugih bolesti).
English: For information on undesirable effects, see section 4.8.
Croatian: Za informacije o nuspojavama, vidjeti dio 4.8.
English: However, as adverse reactions such as diziness have been reported, caution is advised during such activities when beginning Brintellix treatment or changing the dose.
Croatian: Međutim, kako su prijavljene nuspojave kao što je omaglica, savjetuje se oprez tijekom tih aktivnosti u početku liječenja Brintellixom ili pri promjeni doze.
English: Irreversible non-selective MAOIs
Croatian: Ireverzibilni neselektivni MAOI-i
English: Side effects listed below have been reported in the following frequencies.
Croatian: Nuspojave navedene ispod su prijavljene sa sljedećim učestalostima.
English: Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes.
Croatian: Liječenje treba pratiti pomni nadzor bolesnika, a posebno onih s visokim rizikom te osobito u ranim fazama liječenja i nakon promjena doze.
English: This medicinal product contains small amounts of ethanol, less than 100 mg per dose.
Croatian: Ovaj lijek sadrži male količine etanola, manje od 100 mg po dozi.
English: Fertility studies in male and female rats showed no effect of vortioxetine on fertility, sperm quality or mating performance (see section 5.3).
Croatian: Ispitivanja plodnosti u muških i ženskih štakora nisu pokazale učinke vortioksetina na plodnost, kakvoću sperme ili sposobnost parenja (vidjeti dio 5.3).
English: If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Croatian: Ako ikada počnete misliti o samoozljeđivanju ili samoubojstvu, obratite se svom liječniku ili odmah idite u bolnicu.
English: Medicinal products lowering the seizure threshold Antidepressants with serotonergic effect can lower the seizure threshold.
Croatian: Antidepresivi sa serotonergičkim učinkom mogu sniziti prag napadaja.
English: The efficacy of vortioxetine 10 or 20 mg/day was further demonstrated in a 12-week, double-blind, flexible-dose comparative study versus agomelatine 25 or 50 mg/day in patients with MDD.
Croatian: Djelotvornost vortioksetina 10 ili 20 mg dnevno je nadalje bila pokazana u 12 tjedenskom, dvostruko slijepom usporednom ispitivanju fleksibilnih doza naspram agomelatina 25 ili 50 mg dnevno u bolesnika s MDD.
English: This was supported by clinical relevance as demonstrated by the proportions of responders and remitters and the improvement in the Clinical Global Impression - Global Improvement (CGI-I) score.
Croatian: To je bilo podržano i kliničkom relevantnošću, kao što je pokazano udjelima onih koji su odgovorili i koji su u remisiji te poboljšanjem u rezultatu Općeg Kliničkog Dojma - Općeg Poboljšanja (engl.
English: 15 ml in an amber glass bottle (type III) and screw cap (polypropylene) with dropper (LDpolyethylene), (child-resistant closure).
Croatian: 15 ml u jantarnoj staklenoj boci (tip III) sa zatvaračem s navojem (polipropilen) i kapaljkom (LDpolietilen) (zatvarač siguran za djecu).
English: It is expected that vortioxetine will be excreted into human milk (see section 5.3).
Croatian: Očekivano je da će se vortioksetin izlučiti u majčino mlijeko u ljudi (vidjeti dio 5.3).
English: If you forget to take Brintellix
Croatian: Ako ste zaboravili uzeti Brintellix
English: - mefloquine (a medicine to prevent and treat malaria).
Croatian: - meflokin (lijek za prevenciju i liječenje malarije).
English: - The other ingredients are hydroxypropylbetadex, ethanol (96 percent) and purified water
Croatian: - Drugi sastojci su hidroksipropilbetadeks, etanol (96 postotni) i voda, pročišćena.
English: These symptoms could be due to either discontinuation effects or excess serotonergic activity.
Croatian: Ti se simptomi mogu javiti ili zbog učinaka prekida liječenja ili zbog povećane serotonergičke aktivnosti.
English: Vortioxetine must be discontinued for at least 14 days before starting treatment with an irreversible non-selective MAOI (see section 4.3).
Croatian: Liječenje vortioksetinom mora se prekinuti najmanje 14 dana prije početka liječenja ireverzibilnim neselektivnim MAOI-ma (vidjeti dio 4.3).
English: When a single dose of 20 mg vortioxetine was co-administered following 10 days of rifampicin 600 mg/day (a broad inducer of CYP isozymes) in healthy subjects, a 72% decrease in AUC of vortioxetine was observed.
Croatian: Kada je jedna doza od 20 mg vortioksetina istodobno primjenjena nakon 10 dana rifampicina 600 mg/dan (induktor širokog spektra CYP izoenzima) u zdravih ispitanika, opaženo je smanjenje od 72% u AUC-u vortioksetina.
English: No clinically significant changes were observed in hepatic or renal assessments in clinical studies.
Croatian: Nisu opažene klinički značajne promjene u pretragama jetre ili bubrega u kliničkim ispitivanjima.
English: The film-coated tablets can be taken with or without food.
Croatian: Filmom obložene tablete se mogu uzeti sa ili bez hrane.
English: Vortioxetine had no effect on rat fertility, mating performance, reproductive organs, or sperm morphology and motility.
Croatian: Vortioksetin nije imao učinka na plodnost štakora, sposobnost parenja, reproduktivne organe ili morfologiju i pokretljivost sperme.
English: Vortioxetine separated from placebo statistically with results of 8.0 for vortioxetine versus 5.1 points for placebo (p=0.0003).
Croatian: Vortioksetin se statistički odvojio od placeba s rezultatima 8,0 bodova za vortioksetin naspram 5,1 bod za placebo (p=0,0003).
English: Pack sizes of 100 and 200 film-coated tablets.
Croatian: Veličine pakiranja od 100 i 200 filmom obloženih tableta.
English: Most cases were a combination of airway and skin symptoms.
Croatian: Većinu su slučajeva sačinjavale kombinacije simptoma vezanih uz dišne puteve i kožu.
English: Each bottle contains 15 ml Brintellix oral drops, solution.
Croatian: Svaka boca sadrži 15 ml Brintellixa oralnih kapi, otopine.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Brintellix treatment taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja Brintellixom, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Ingestion of vortioxetine in clinical trials in the dose range of 40 mg to 75 mg has caused an aggravation of the following adverse reactions: nausea, postural dizziness, diarrhoea, abdominal discomfort, generalised pruritus, somnolence and flushing.
Croatian: Primjena vortioksetina u kliničkim ispitivanjima u rasponu doze od 40 mg do 75 mg prouzročila je pogoršanje sljedećih nuspojava: mučnine, posturalne omaglice, proljeva, abdominalne nelagode, generaliziranog pruritusa, somnolencije i navale crvenila.
English: When adjusting for the change in MADRS the total score in the meta-analysis of the same studies showed that vortioxetine separated from placebo (p<0.05) with a standardised effect size of 0.24.
Croatian: Pri prilagodbi za promjenu u MADRS-u, ukupni rezultat u meta analizi istih ispitivanja pokazao je da se vortioksetin odvojio od placeba (p<0,05) sa standardiziranom veličinom učinka od 0,24.
English: The efficacy of vortioxetine (5-20 mg/day) in patients with MDD has been investigated in 2 adult and 1 elderly short-term, placebo-controlled studies.
Croatian: Djelotvornost vortioksetina (5-20 mg/dan) u bolesnika s MDD-om je ispitivana u 2 kratkoročna placebom kontrolirana ispitivanja u odraslih i 1 kratkoročnom placebom kontroliranom ispitivanju u starijih osoba.
English: Your doctor will make a decision on whether you should stop breast-feeding, or stop using Brintellix taking into account the benefit of breast-feeding for your child, and the benefit of therapy for you.
Croatian: Vaš će liječnik odlučiti da li morate prekinuti dojenje ili prekinuti uzimanje Brintellixa uzimajući u obzir korist dojenja za dijete i korist liječenja za Vas.
English: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a medicinal product from related pharmacological classes of antidepressants (SSRIs or TCAs).
Croatian: Epidemiološka ispitivanja, uglavnom provedena u bolesnika u dobi od 50 godina i starijih, pokazuju povećan rizik od prijeloma kostiju u bolesnika koji primaju lijekove iz srodne farmakološke skupine antidepresiva (SSRI ili tricikličke antidepresive (TCA)).
English: This syndrome may be associated with hallucinations, involuntary twitching, accelerated heartbeat, high blood pressure, fever, nausea and diarrhoea.
Croatian: Ovaj sindrom može biti povezan s halucinacijama, nevoljnim trzanjem mišića, ubrzanim otkucajima srca, visokim krvnim tlakom, vrućicom, mučninom i proljevom.
English: Concomitant use with nonselective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (see section 4.5).
Croatian: Istodobna primjena s neselektivnim inhibitorima monoaminooksidaze (MAOI) ili sa selektivnim MAO-A inhibitorima (vidjeti dio 4.5).
English: - Based upon the review of a signal for rash, a plausible temporal relationship was concluded in several post-marketing cases reported (74% of reported time to onset was within one week and 93% was within one month), including cases with positive de- or re-challenge (respectively 135 and 8 cases).
Croatian: U sklopu ocjene signala osipa, vremenska povezanost nekoliko slučajeva prijavljenih nakon stavljanja lijeka u promet ocijenjena je kao vjerojatna (vremenski okvir do nastupa u 74% slučajeva bio je tjedan dana, a u 93% slučajeva mjesec dana), uključujući i slučajeve s pozitivnim dechallenge-om ili rechallenge-om (135, odnosno 8 slučajeva).
English: In studies using the Arizona Sexual Experience Scale (ASEX), the incidence of treatment-emergent sexual dysfunction (TESD) and the ASEX total score showed no clinically relevant difference to placebo in symptoms of sexual dysfunction at the 5 to 15 mg/day doses of vortioxetine.
Croatian: Arizona Sexual Experience Scale, (ASEX)), incidencija spolne disfunkcije koja se javila tijekom liječenja te ukupni rezultat ASEX-a, nisu pokazali klinički relevantne razlike u odnosu na placebo po pitanju simptoma spolne disfunkcije pri dozama vortioksetina od 15 mg/dan.