FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Previdnost je potrebna pri ogroženih bolnikih, kot so starejši bolniki ali bolniki s cirozo jeter oziroma bolniki, sočasno zdravljeni z zdravili, za katere je znano, da povzročajo hiponatriemijo.
English: Co-administration resulted in a higher incidence of adverse reactions when bupropion was added to vortioxetine than when vortioxetine was added to bupropion.
Slovenian: Sočasna uporaba je privedla do večjega pojavljanja neželenih učinkov, ko je bil bupropion dodan vortioksetinu, kot pa takrat, ko je bil vortioksetin dodan bupropionu.
English: Brintellix oral drops are not to be mixed with other medicinal products.
Slovenian: Zdravilo Brintellix peroralne kaplice se ne smejo mešati z drugimi zdravili.
English: Other medicines and Brintellix
Slovenian: Druga zdravila in zdravilo Brintellix
English: You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.
Slovenian: Morda bi bilo koristno, če za težave z depresijo poveste sorodniku ali dobremu prijatelju in ga prosite, da prebere to navodilo.
English: Brintellix is not to be used during breast-feeding.
Slovenian: Zdravilo Brintellix se ne sme uporabljati med dojenjem.
English: The risk of SS or NMS is increased with concomitant use of serotonergic-active substances (including triptans), medicinal products that impair the metabolism of serotonin (including MAOIs), antipsychotics, and other dopamine antagonists.
Slovenian: Tveganje za SS ali NMS je povečano pri sočasni uporabi serotonergičnih zdravilnih učinkovin (vključno s triptani), zdravil, ki ovirajo presnovo serotonina (vključno z zaviralci MAO), antipsihotikov in drugih dopaminskih antagonistov.
English: Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS), potentially life-threatening conditions, may occur with vortioxetine.
Slovenian: Serotoninski sindrom (SS) ali nevroleptični maligni sindrom (NMS), potencialno življenjsko nevarni stanji, se lahko pojavita pri vortioksetinu.
English: This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Slovenian: To zdravilo vsebuje majhno količino etanola (alkohola), in sicer manj kot 100 mg na odmerek.
English: What Brintellix is and what it is used for
Slovenian: Kaj je zdravilo Brintellix in za kaj ga uporabljamo
English: - have a severe kidney disease.
Slovenian: - imate hudo bolezen ledvic.
English: Patients treated with vortioxetine can abruptly stop taking the medicinal product without the need for a gradual reduction in dose (see section 5.1).
Slovenian: Bolniki, ki se zdravijo z vortioksetinom, lahko brez potrebe po postopnem zmanjševanju odmerka nenadno prenehajo z jemanjem zdravila (glejte poglavje 5.1).
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.
Slovenian: Učinkovitost vortioksetina so dokazali z vsaj eno skupino odmerjanja v 9 od 12 študij, ki so pokazale najmanj 2 točki razlike glede na placebo v skupnem številu točk po Montgomeryevi in Åsbergovi lestvici za ocenjevanje depresije (MADRS - Montgomery and Åsberg Depression Rating Scale) ali Hamiltonovi lestvici za ocenjevanje depresije s 24 postavkami (HAM-D24 - Hamilton Depression Rating Scale 24-item).
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).
Slovenian: - Pri pregledu znakov za izpuščaj so zaključili, da obstaja za več poročanih primerov iz obdobja trženja verjetno časovno razmerje (v 74 % so poročali o enem tednu do začetka, v 93 % pa je bil začetek v roku enega meseca), vključno s primeri s pozitivnim testom ukinitve ali ponovne uvedbe zdravila (135 primerov za prvo in 8 za drugo).
English: Post-marketing experience mainly concerns vortioxetine overdoses of up to 80 mg.
Slovenian: Izkušnje po začetku trženja se večinoma nanašajo le na prekomerne odmerke vortioksetina do 80 mg.
English: Brintellix contains ethanol.
Slovenian: Zdravilo Brintellix vsebuje etanol.
English: The reactions were usually temporary and did not lead to cessation of therapy.
Slovenian: Neželeni učinki so bili običajno začasni in niso povzročali prekinitev zdravljenja.
English: In vitro, vortioxetine did not show any relevant potential for inhibition or induction of cytochrome P450 isozymes (see section 5.2).
Slovenian: In vitro vortioksetin ni pokazal relevantnega potenciala za inhibicijo ali indukcijo izoencimov citokroma P450 (glejte poglavje 5.2).
English: Vortioxetine has not shown any clinically significant effect on ECG parameters, including the QT, QTc, PR and QRS intervals, in patients with MDD.
Slovenian: Pri bolnikih z MDD vortioksetin ni pokazal nobenega klinično pomembnega vpliva na parametre EKG, vključno z intervali QT, QTc, PR in QRS.
English: It is expected that vortioxetine will be excreted into human milk (see section 5.3).
Slovenian: Pričakovati je, da se bo vortioksetin izločal v materino mleko (glejte poglavje 5.3).
English: The safety and tolerability of vortioxetine have been established in short- and long-term studies across the dose range of 5 to 20 mg/day.
Slovenian: Varnost in prenašanje vortioksetina so ugotovili v kratko- in dolgoročnih študijah v razponih odmerkov od 5 do 20 mg/dan.
English: Vortioxetine must not be initiated for at least 14 days after discontinuation of treatment with an irreversible non-selective MAOI.
Slovenian: Vortioksetina se ne sme uvesti še vsaj 14 dni po prenehanju zdravljenja z neselektivnim ireverzibilnim zaviralecem MAO.
English: If you take more than the prescribed dose of Brintellix, contact your doctor or nearest hospital emergency department immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Brintellix, kot bi smeli Če ste vzeli večji odmerek od predpisanega odmerka zdravila Brintellix, takoj obvestite svojega zdravnika ali se obrnite na oddelek za nujno pomoč najbližje bolnišnice.
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.
Slovenian: - Na podlagi vpliva serotonina na hemostazo, mehanizma delovanja vortioksetina in 63 primerov v obdobju trženja, ki so kazali znake krvavitev z možno vzročno povezavo z vortioksetinom, je bilo ocenjeno, da je krvavitev treba vključiti kot neželeni učinek zdravila v infomacije o zdravilu za vortioksetin.
English: After first opening the drops should be used within 8 weeks.
Slovenian: Po odprtju je treba kapljice porabiti v 8 tednih.
English: If this happens to your baby, you should contact your midwife and/or doctor immediately.
Slovenian: Če se to zgodi vašemu otroku, morate takoj stopiti v stik z babico oziroma zdravnikom.
English: A no-effect level for convulsions was established with a corresponding safety margin of 5 considering the maximum recommended therapeutic dose of 20 mg/day.
Slovenian: Za konvulzije je bila vrednost brez učinka ugotovljena z ustrezno mejo varnosti v višini 5, upoštevajoč največji priporočeni terapevtski odmerek 20 mg/dan.
English: Administration of vortioxetine in the general toxicity studies in mice, rats and dogs was mainly associated with CNS-related clinical signs.
Slovenian: V študijah splošne toksičnosti pri miših, podganah in psih je bilo jemanje vortioksetina v glavnem povezano s kliničnimi znaki, povezanimi s CNS.
English: lactate).
Slovenian: laktata).
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.
Slovenian: Učinkovitost vortioksetina v odmeku 10 ali 20 mg/dan je bila nadalje dokazana v 12- tedenski, dvojno slepi, primerjalni študiji s prilagodljivim odmerkom v primerjavi z agomelatinom v odmerku 25 ali 50 mg/dan pri bolnikih z MDD.
English: Have the bottle and any remaining solution available.
Slovenian: Imejte steklenico in preostalo raztopino pri sebi.
English: Combining this medicine with alcohol is not advisable.
Slovenian: Uživanje alkohola ob sočasnem jemanju tega zdravila ni priporočljivo.
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Slovenian: Neželeni učinki so našteti po naslednji razvrstitvi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznano (ni mogoče oceniti iz razpoložljivih podatkov).
English: However, there have been reports of enhanced effects when antidepressants with serotonergic effect have been given together with lithium or tryptophan; therefore, concomitant use of vortioxetine with these medicinal products should be undertaken with caution.
Slovenian: Vendar obstajajo poročila o povečanih učinkih antidepresivov s serotonergičnim učinkom ob sočasnem dajanju litija ali triptofana, zato je pri sočasni uporabi vortioksetina in teh zdravil potrebna previdnost.
English: Tolerability and safety
Slovenian: Prenašanje in varnost
English: If you have taken any of these medicines, you will need to wait 14 days before you start taking Brintellix.
Slovenian: Če jemljete katero izmed teh zdravil, je potrebno počakati 14 dni, preden začnete jemati zdravilo Brintellix.
English: You may be more likely to think like this if you: - have previously had thoughts about killing or harming yourself.
Slovenian: Pojav takšnih misli je verjetnejši: - če ste že kdaj razmišljali o samomoru ali samopoškodovanju; - če ste mlajša odrasla oseba.
English: Vortioxetine was statistically significantly better than agomelatine as measured by improvement in the MADRS total score and supported by the clinical relevance as demonstrated by the proportions of responders and remitters and improvement in the CGI-I.
Slovenian: Vortioksetin je bil statistično značilno boljši kot agomelatin, kar so izmerili z izboljšanjem skupnega števila točk po lestvici MADRS in podprli s kliničnim pomenon, ki se kaže z deleži odzivnih bolnikov in bolnikov v remisiji in z izboljšanjem ocene po lestvici CGI-I.
English: Patients in remission after an initial 12-week open-label treatment period with vortioxetine were randomised to vortioxetine 5 or 10 mg/day or placebo and observed for relapse during a double-blind period of at least 24 weeks (24 to 64 weeks).
Slovenian: Bolnike v remisiji po začetnem 12-tedenskem obdobju odprte faze zdravljenja z vortioksetinom so randomizirali na vortioksetin v odmerku 5 ali 10 mg/dan ali na placebo in jih opazovali glede relapsa v dvojno slepem obdobju najmanj 24 tednov (24-64 tednov).
English: Vortioxetine-related material was distributed to the milk of lactating rats (see section 4.6).
Slovenian: Z vortioksetinom povezane snovi so prešle v mleko doječih podgan (glejte poglavje 4.6).
English: Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily.
Slovenian: Glede na odziv posameznega bolnika se odmerek lahko zviša na največ 20 mg vortioksetina enkrat na dan ali zniža na najmanj 5 mg vortioksetina enkrat na dan.
English: Do not use this medicine after the expiry date that is stated on the packaging after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Depending on individual patient response, a dose adjustment may be considered (see section 4.2).
Slovenian: Glede na odziv posameznega bolnika je potrebno razmisliti o prilagoditvi odmerka (glejte poglavje
English: Limited data are available for patients with severe renal impairment.
Slovenian: Za bolnike s hudo okvarjenim delovanjem ledvic so na voljo le omejeni podatki.
English: Take Brintellix for as long as your doctor recommends.
Slovenian: Zdravilo Brintellix morate jemati tako dolgo, kot vam to predpiše zdravnik.
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.
Slovenian: Vortioksetin je bil boljši (p=0,004) od placeba glede na primarno merilo za oceno izida, čas do ponovitve MDD, z razmerjem tveganja 2.0; to pomeni, da je bilo tveganje za ponovitev bolezni v skupini, ki je prejemala placebo, dvakrat višje kot v skupini, ki je prejemala vortioksetin.
English: Potential for other medicinal products to affect vortioxetine
Slovenian: Možnost vpliva drugih zdravil na vortioksetin
English: [outer carton only]
Slovenian: [samo zunanja škatla]
English: Pack sizes of 100 and 200 film-coated tablets.
Slovenian: Pakiranje s 100 in 200 filmsko obloženimi tabletami.
English: Reversible, non-selective MAOI (linezolid)
Slovenian: Neselektivni reverzibilni zaviralec MAO (linezolid)
English: Additionally, the class warning on haemorrhage should be updated, to add that haemorrhage has been reported with vortioxetine as well.
Slovenian: Dodatno je treba posodobiti opozorilo glede krvavitve v sklopu organskega sistema in dodati, da so o krvavitvi poročali tudi v povezavi z vortioksetinom.
English: No clinically significant changes were observed in hepatic or renal assessments in clinical studies.
Slovenian: V kliničnih študijah niso opazili klinično pomembnih sprememb pri oceni jeter ali ledvic.
English: Only negligible amounts of vortioxetine are excreted in the faeces.
Slovenian: Le zanemarljive količine vortioksetina se izločijo z blatom.
English: - quinidine (a medicine to treat heart rhythm disorders).
Slovenian: - kinidin (zdravilo proti motnjam srčnega ritma).
English: The plasma concentration of vortioxetine was approximately two times higher in CYP2D6 poor metabolisers than in extensive metabolisers.
Slovenian: Koncentracija vortioksetina v plazmi je bila približno dvakrat višja pri bolnikih z upočasnjeno presnovo s CYP2D6 kot pri tistih z obsežno presnovo.
English: Your doctor will treat you cautiously if you have a history of fits or have unstable fit disorder/epilepsy.
Slovenian: Vaš zdravnik vas bo zdravil previdno, če ste kdaj imeli krče ali imate nestabilna obolenja s krči/ epilepsijo.
English: Following multiple dosing of 5, 10, or 20 mg/day, mean Cmax values of 9 to 33 ng/mL were observed.
Slovenian: Po večkratnem odmerjanju 5, 10, ali 20 mg/dan so opazili povprečno Cmax od 9 do 33 ng/ml.
English: - rifampicin (a medicine to treat tuberculosis and other infections).
Slovenian: - rifampicin (zdravilo za zdravljenje tuberkuloze in drugih okužb).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
Slovenian: ZUNANJA NALEPKA NA VEČKRATNEM PAKIRANJU V FOLIJI (VKLJUČUJE "BLUE BOX")
English: Fertility studies in male and female rats showed no effect of vortioxetine on fertility, sperm quality or mating performance (see section 5.3).
Slovenian: Študije o vplivu na sposobnost razmnoževanja pri samcih in samicah podgan niso pokazale nobenega vpliva vortioksetina na plodnost, kakovost sperme ali uspešnost parjenja (glejte poglavje 5.3).
English: Vortioxetine had no effect on rat fertility, mating performance, reproductive organs, or sperm morphology and motility.
Slovenian: Vortioksetin ni vplival na plodnost podgan, uspešnost parjenja, reproduktivne organe ali morfologijo in gibljivost sperme.
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.
Slovenian: Zdravnik lahko poveča odmerek do največ 20 mg vortioksetina dnevno ali zmanjša na najmanj 5 mg vortioksetina dnevno, odvisno od tega, kako se odzivate na zdravilo.
English: - if you are taking other medicines for depression known as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors.
Slovenian: - če jemljete druga zdravila za zdravljenje depresije, imenovana neselektivni zaviralci monoaminooksidaze ali selektivni zaviralci MAO-A.
English: - carbamazepine, phenytoin (medicines to treat epilepsy or other illness).
Slovenian: - karbamazepin, fenitoin (zdravili za zdravljenje epilepsije ali drugih bolezni).
English: This medicinal product contains small amounts of ethanol, less than 100 mg per dose.
Slovenian: To zdravilo vsebuje majhne količine etanola, in sicer manj kot 100 mg na odmerek.
English: Vortioxetine separated from placebo statistically with results of 8.0 for vortioxetine versus 5.1 points for placebo (p=0.0003).
Slovenian: Vortioksetin se je statistično ločil od placeba z rezultatom 8,0 točk za vortioksetin v primerjavi s 5,1 točk za placebo (p = 0,0003).
English: Brintellix with alcohol
Slovenian: Zdravilo Brintellix skupaj z alkoholom
English: In a pre- and post-natal study in rats, vortioxetine was associated with increased pup mortality, reduced bodyweight gain, and delayed pup development at doses that did not result in maternal toxicity and with associated exposures similar to those achieved in humans following administration of vortioxetine 20 mg/day (see section 4.6).
Slovenian: V študiji pre- in postnatalne toksičnosti pri podganah je bil vortioksetin povezan s povečano smrtnostjo mladičev, zmanjšanim pridobivanjem telesne mase in zapoznelim razvojem mladičev pri odmerkih, ki niso povzročili toksičnosti za mater in s povezanimi izpostavljenostmi, podobnim tistim, ki so bili doseženi pri ljudeh po jemanju vortioksetina v odmerku 20 mg/dan (glejte poglavje 4.6).
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.
Slovenian: Ugotovljeno je, da zdravilo Brintellix zmanjša širok spekter simptomov depresije, ki zajemajo žalost, notranjo napetost (občutek tesnobe), motnje spanja (zmanjšanje spanja), zmanjšanje apetita, težavo s koncentracijo, občutke ničvrednosti, izgubo zanimanja za stvari, ki so bolnika prej veselile, in občutek splošne upočasnjenosti.
English: Very common: may affect more than 1 in 10 people - nausea
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov slabost
English: Therefore, caution should be exercised when treating patients ≥ 65 years of age with doses higher than 10 mg vortioxetine once daily (see sections 4.2, 4.8 and 5.2).
Slovenian: Zato je potrebna previdnost pri zdravljenju bolnikov, starih ≥ 65 let, z odmerki, višjimi od 10 mg vortioksetina enkrat na dan (glejte poglavja 4.2, 4.8 in 5.2).
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).
Slovenian: Epidemiološke študije, opravljene večinoma pri bolnikih, starejših od 50 let, kažejo povečano tveganje za zlome kosti pri bolnikih, ki dobivajo antidepresive iz podobne farmakološke skupine (SSRI in TCA).
English: Pharmacotherapeutic group: Psychoanaleptics; Other antidepressants, ATC code: N06AX26
Slovenian: Farmakoterapevtska skupina: psihoanaleptiki; drugi antidepresivi, oznaka ATC: N06AX26
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.
Slovenian: V študijah z arizonsko lestvico spolne izkušnje (ASEX), incidenca spolne disfunkcije zaradi zdravljenja (TESD) in skupno število točk po lestvici ASEX ni pokazalo klinično pomembnih razlik v primerjavi s placebom glede simptomov spolne disfunkcije pri odmerkih 5 do 15 mg/dan vortioksetina.
English: - warfarin, dipyridamole, phenprocoumon, low-dose acetylsalicylic acid (blood thinning medicines).
Slovenian: - varfarin, dipiridamol, fenprokumon, majhni odmerki acetilsalicilne kisline (zdravila za redčenje krvi).
English: Vortioxetine was not teratogenic in rats or rabbits, but reproductive toxicity in terms of effects on foetal weight and delayed ossification were seen in the rat at exposures more than 10-fold the human exposure at the maximum recommended therapeutic dose of 20 mg/day.
Slovenian: Vortioksetin ni bil teratogen pri podganah ali kuncih, vendar so opazili reproduktivno toksičnost v smislu vplivov na maso ploda in zapoznelo osifikacijo pri podgani pri izpostavljenostih večjih od 10-kratne izpostavljenosti za človeka pri največjem priporočenem terapevtskem odmerku 20 mg/dan.
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.
Slovenian: Pri bolnikih z izjemno hitro presnovo s CYP2D6 so bile koncentracije vortioksetina v odmerku 10 mg/dan v plazmi med vrednostmi koncentracij, pridobljenih pri bolnikih z obsežno presnovo pri odmerkih 5 mg/dan in 10 mg/dan.
English: - have had fits (seizures).
Slovenian: - ste kdaj imeli krče (epilepične napade).
English: The film-coated tablets can be taken with or without food.
Slovenian: Filmsko obložene tablete se lahko jemlje s hrano ali brez nje.
English: Lithium, tryptophan
Slovenian: Litij, triptofan
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.
Slovenian: Učinkovitost vortioksetina (5-20 mg/dan) pri bolnikih z MDD je bila raziskovana v 2 s placebom kontroliranih kratkotrajnih študijah pri odraslih in v 1 s placebom kontrolirani kratkotrajni študiji pri starejših.
English: However, caution should be exercised when vortioxetine is combined with oral anticoagulants or antiplatelet medicinal products due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction (see section 4.4).
Slovenian: Vendar pa je pri kombinaciji vortioksetina s peroralnimi antikoagulanti ali antitrombotičnimi zdravili potrebna previdnost zaradi možnega povečanega tveganja za krvavitev, ki se lahko pripiše farmakodinamični interakciji (glejte poglavje 4.4).
English: The reactions were usually transient and did not generally lead to cessation of therapy.
Slovenian: Neželeni učinki so običajno bili prehodni in zaradi njih na splošno ni bilo treba prekiniti zdravljenja.
English: This syndrome may be associated with hallucinations, involuntary twitching, accelerated heartbeat, high blood pressure, fever, nausea and diarrhoea.
Slovenian: Ta sindrom je lahko povezan s halucinacijami, nehotenim trzanjem, pospešenim bitjem srca, visokim krvnim tlakom, zvišano telesno temperaturo, slabostjo in drisko.
English: In elderly healthy subjects (aged ≥65 years; n=20), the exposure to vortioxetine increased up to 27% (Cmax and AUC) compared to young healthy control subjects (aged ≤45 years) after multiple doses of
Slovenian: Pri starejših zdravih osebah (starih ≥ 65 let; n=20) se je izpostavljenost povečala do 27 % (Cmax in AUC) v primerjavi z mladimi zdravimi kontroliranimi osebami (starimi ≤ 45 let) po večkratnih odmerkih 10 mg/dan.
English: Vortioxetine must be discontinued for at least 14 days before starting treatment with an irreversible non-selective MAOI (see section 4.3).
Slovenian: Uporabo vortioksetina je treba prekiniti vsaj 14 dni pred začetkom zdravljenja z neselektivnim ireverzibilnim zaviralcem MAO (glejte poglavje 4.3).