FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents aged 8 years and above:
Slovenian: Otroci in mladostniki, stari 8 let in več:
English: After the CD, the Member State competent authorities will update the product information as required.
Slovenian: Pristojne oblasti držav članic bodo po odločbi Komisije informacije o zdravilu posodobile v skladu z zahtevami.
English: Cyproheptadine or dantrolene may benefit patients experiencing such reactions.
Slovenian: Bolnikom s takimi reakcijami lahko koristita ciproheptadin ali dantrolen.
English: An extended time for close medical observation may be needed in patients who have taken excessive quantities of a tricyclic antidepressant if they are also taking, or have recently taken, fluoxetine.
Slovenian: Pri bolnikih, ki so zaužili večje količine tricikličnih antidepresivov, bo morda potrebno podaljšanje skrbnega zdravstvenega spremljanja, če so sočasno jemali ali v zadnjem času zaužili tudi fluoksetin.
English: • the CHMP agreed that the benefits/risk balance for fluoxetine in the treatment of moderate to severe major depressive episode in children and adolescents aged 8 to 18 is favourable,
Slovenian: • CHMP se je strinjal, da je razmerje med koristmi in tveganji za fluoksetin pri zdravljenju zmernih do močno izraženih hudih epizod depresije pri otrocih in mladostnikih v starosti od 8 do 18 let, ugodno.
English: The dose should be increased carefully to ensure that you receive the lowest effective dose.
Slovenian: Odmerek povečujemo previdno, s čimer zagotovimo, da dobite najmanjši učinkoviti odmerek.
English: In the second study, with intermittent luteal phase dosing (20 mg daily for 14 days) for 3 cycles, improvement was observed in the primary efficacy parameter (Daily Record of Severity of Problems score).
Slovenian: V drugi študiji, s prekinjenim odmerjanjem v lutealni fazi (20 mg na dan 14 dni) 3 cikluse, so opažali izboljšanje primarne spremenljivke učinkovitosti (število točk po beleženju hudosti težav na dan (Daily Record of Severity of Problems)).
English: There is only limited data on treatment beyond 9 weeks.
Slovenian: Podatki za zdravljenje, daljše od 9 tednov, so omejeni.
English: If no clinical benefit is achieved within 9 weeks, treatment should be reconsidered.
Slovenian: Če po 9 tednih ni nobene klinične koristi, ponovno razmislimo o smiselnosti zdravljenja.
English: • the CHMP agreed that appropriate warnings to inform doctors and parents about the need to monitor patients for the appearance of events in relation to growth, pubertal development, hostility and suicide related behaviour should be strengthen in the product information,
Slovenian: • CHMP se je strinjal, da je v podatkih o zdravilu treba okrepiti ustrezna opozorila, s katerimi se zdravnike in starše seznani, da je bolnike potrebno spremljati zaradi morebitnih dogodkov, povezanih z rastjo, razvojem v puberteti, sovražnostjo in s samomorilnim vedenjem;
English: • Elderly: Kinetic parameters are not altered in healthy elderly when compared to younger subjects
Slovenian: Skupine s tveganji • Starejši: Kinetične spremenljivke pri zdravih starejših v primerjavi z mlajšimi niso drugačne.
English: The third was a trial sponsored by the National Institute of Mental Health (NIMH) - the Treatment of Adolescents with Depression trial (TADS).
Slovenian: Tretjo raziskavo - Zdravljenje mladostnikov z depresijo (TADS) - je sponzoriral Nacionalni inštitut za mentalno zdravje.
English: However, the combination of SSRI treatment and alcohol is not advisable.
Slovenian: Vendar pa kombinacija zdravljenja s selektivnimi zaviralci prevzema serotonina in alkohola ni priporočljiva.
English: In the first study of continuous 20 mg daily dosing for 6 cycles, improvement was observed in the primary efficacy parameter (irritability, anxiety and dysphoria).
Slovenian: V prvi študiji, s stalnim odmerjanjem 20 mg na dan 6 ciklusov, so opažali izboljšanje primarne spremenljivke učinkovitosti (razdražljivost, tesnoba in disforija).
English: When stopping treatment with (Invented name)® the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see section 4.4 Special warnings and precautions for use and section 4.8 Undesirable Effects).
Slovenian: Ob ukinjanju zdravljenja s (Izmišljeno ime)® odmerek postopno zmanjšujemo v obdobju najmanj enega do dveh tednov z namenom zmanjšanja tveganja za pojav odtegnitvenih reakcij (glejte poglavje 4.4 Posebna opozorila in previdnostni ukrepi in poglavje 4.8 Neželeni učinki).
English: Withdrawal symptoms seen on discontinuation of (Invented name)®: Abrupt discontinuation should be avoided.
Slovenian: Odtegnitveni simptomi ob prekinitvi zdravljenja s (Izmišljeno ime)®: Izogibati se moramo nenadni prekinitvi zdravljenja.
English: Akathisia/psychomotor restlessness: The use of fluoxetine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Slovenian: Akatizija/psihomotorični nemir: Uporabo fluoksetina so povezovali z razvojem akatizije, za katero je značilen osebno neprijeten, mučen nemir in potreba po gibanju, ki jo pogosto spremlja nezmožnost sedenja ali stanja pri miru.
English: • start to experience fever, muscle stiffness or tremor, changes in your mental state like confusion, irritability and extreme agitation; you may suffer from the so called serotonin syndrome or neuroleptic malignant syndrome.
Slovenian: • občutite povišano telesno temperaturo, okorelost mišic ali tresenje, spremembe v vašem duševnem stanju, kot so zmedenost, razdražljivost in huda vznemirjenost; lahko imate tako imenovani serotoninski sindrom ali nevroleptični maligni sindrom.
English: Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting a MAOI.
Slovenian: Prav tako mora preteči najmanj 5 tednov po prekinitvi zdravljenja s fluoksetinom, preden začnemo zdravljenje z zaviralcem monoaminooksidaze.
English: The MAH also committed to use registries in some Member States that could be used to provide data on the effects of fluoxetine on sexual maturation.
Slovenian: Imetnik dovoljenja za promet z zdravilom je tudi prevzel obveznost, da bo v nekaterih državah članicah uporabil registre, ki jih je mogoče uporabiti za zagotovitev podatkov glede vplivov fluoksetina na spolno dozorevanje.
English: Major depressive episodes (children and adolescents): Clinical trials in children and adolescents aged 8 years and above have been conducted versus placebo.
Slovenian: Velike depresivne epizode (otroci in mladostniki): Izvedli so klinična preskušanja pri otrocih in mladostnikih, starih 8 let in več, v primerjavi s placebom.
English: Eli Lilly Sweden AB Gustav III:s boulevard 42, P.O.
Slovenian: Eli Lilly Sweden AB Gustav III:s boulevard 42, P.O. Box 721
English: Do not take (Invented name)® and tell your doctor or pharmacist if the following apply:
Slovenian: Ne jemljite zdravila (Izmišljeno ime)® in povejte svojemu zdravniku ali farmacevtu, če za vas velja:
English: Hepatic/Renal Function: Fluoxetine is extensively metabolised by the liver and excreted by the kidneys.
Slovenian: Delovanje jeter/ledvic: Fluoksetin se obsežno presnavlja v jetrih in izloča skozi ledvice.
English: The capsule shell is made of gelatin, patent blue V (E131), yellow iron oxide (E172), titanium dioxide (E171).
Slovenian: Obloga kapsule je narejena iz želatine, modro V (E131), rumenega železovega oksida (E172), titanovega dioksida (E171).
English: If you experience symptoms when you stop treatment, contact your doctor.
Slovenian: Če se po prenehanju zdravljenja pri vas pojavijo ti simptomi, se posvetujte s svojim zdravnikom.
English: The MAH also undertook to participate in a prospective placebo-controlled study, which will explore possible effects of fluoxetine treatment on sexual maturation.
Slovenian: Imetnik dovoljenja za promet z zdravilom je tudi prevzel obveznost, da bo sodeloval pri s placebom kontrolirani raziskavi, ki bo raziskala možne učinke zdravljenja s fluoksetinom na spolno dozorevanje.
English: 13 rue Pagès 92158 Suresnes Cedex FRANCE
Slovenian: 13 rue Pagès 92158 Suresnes Cedex Francija
English: • have suffered from mania in the past; if you have a manic episode, contact your doctor immediately, the use of fluoxetine might need to be discontinued.
Slovenian: • ste kdaj imeli manijo; če se pri vas pojavi manična epizoda, se takoj obrnite na svojega zdravnika, morda bo potrebna prekinitev uporabe fluoksetina.
English: If you take more (Invented name)® than you should
Slovenian: Če ste vzeli večji odmerek zdravila (Izmišljeno ime)®, kot bi smeli
English: Your doctor will review and adjust your dosage if necessary after 2 weeks of treatment.
Slovenian: Vaš zdravnik bo po 2 tednih zdravljenja ocenil in po potrebi prilagodil vaš odmerek.
English: When given fluoxetine 20 mg/day for 2 months, patients with severe renal failure (GFR <10 ml/min) requiring dialysis showed no difference in plasma levels of fluoxetine or norfluoxetine compared to controls with normal renal function.
Slovenian: Ob dajanju fluoksetina 20 mg/dan 2 meseca bolniki s hudo okvarjenim delovanjem ledvic (hitrost glomerulne filtracije < 0,17 ml/s) na dializi niso kazali razlike v plazemskih ravneh fluoksetina ali norfluoksetina v primerjavi s kontrolno skupino z normalnim ledvičnim delovanjem.
English: Bulimia nervosa: (Invented name)® is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity.
Slovenian: Bulimija nervoza: (Izmišljeno ime)® je indiciran kot dopolnilo psihoterapiji za zmanjšanje prenajedanja in bruhanja.
English: If no improvement is observed within 10 weeks, treatment with fluoxetine should be reconsidered.
Slovenian: Če po 10 tednih ni izboljšanja, je treba ponovno razmisliti o smiselnosti zdravljenja s fluoksetinom.
English: Although there may be an increased potential for undesirable effects at higher doses in some patients, if after two weeks there is insufficient response to 20mg, the dose may be increased gradually up to a maximum of 60mg.
Slovenian: Kljub večji možnosti pojava neželenih učinkov pri višjih odmerkih, lahko pri nekaterih bolnikih z nezadostnim odgovorom na 20 mg, odmerek postopno večamo, do največ 60 mg.
English: In common with other SSRIs the following undesirable effects have been seen:
Slovenian: Kot pri drugih selektivnih zaviralcih prevzema serotonina so opažali naslednje neželene učinke:
English: Take special care with (Invented name)® and tell your doctor or pharmacist if you:
Slovenian: Bodite posebno pozorni pri jemanju zdravila (Izmišljeno ime)® in povejte svojemu zdravniku ali farmacevtu, če:
English: Fluoxetine should be discontinued in any patient entering a manic phase.
Slovenian: Zdravljenje s fluoksetinom prekinemo pri vsakem bolniku, pri katerem se pojavi manična faza.
English: (Invented name)® should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes and it should not be used in other indications.
Slovenian: (Izmišljeno ime)® lahko uporabljamo pri otrocih in mladostnikih med 8 in 18 letom starosti za zdravljenje zmernih do hudih velikih depresivnih epizod in ga ne smemo uporabljati za druge indikacije.
English: Elderly: Caution is recommended when increasing the dose and the daily dose should generally not exceed 40 mg.
Slovenian: Starejši: Pri višanju odmerka je potrebna previdnost, odmerek pa naj v splošnem ne presega 40 mg na dan.
English: The MAH committed therefore to study further the characterisation of effects on specified emotional behaviours in juvenile rats.
Slovenian: Imetnik dovoljenja za promet z zdravilom je zato prevzel obveznost, da bo še naprej raziskoval značilnosti učinkov na določena čustvena obnašanja pri mladih podganah.
English: In these studies, (Invented name)® produced a significantly higher rate of response (defined by a 50% decrease in the HAM-D score) and remission, compared to placebo.
Slovenian: V teh študijah je (Izmišljeno ime)® v primerjavi s placebom povzročil značilno višjo stopnja odziva (določeno kot 50 % zmanjšanje števila točk po lestvici HAM-D) in remisije.
English: Obsessive-compulsive disorder.
Slovenian: Obsesivno-kompulzivna motnja.
English: Fluoxetine can be used during pregnancy, but caution should be exercised when prescribing to pregnant women, especially during late pregnancy or just prior to the onset of labour since the following effects have been reported in neonates: irritability, tremor, hypotonia, persistent crying, difficulty in sucking or in sleeping.
Slovenian: Fluoksetin med nosečnostjo lahko uporabljamo, vendar je potrebna previdnost pri predpisovanju fluoksetina nosečim ženskam, zlasti v pozni nosečnosti ali tik pred porodom, ker so pri novorojenčkih poročali o naslednjih učinkih: razdražljivost, tresenje, hipotonija, vztrajno jokanje, težave pri sesanju ali motnje spanja.
English: However caution should be exercised when used during pregnancy, especially during late pregnancy or just before giving birth since the following effects have been reported in new born children: irritability, tremor, muscle weakness, persistent crying, difficulty in sucking or in sleeping.
Slovenian: Kljub temu je ob uporabi med nosečnostjo potrebna previdnost, zlasti v pozni nosečnosti ali tik pred porodom, ker so pri novorojenčkih poročali o naslednjih učinkih: razdražljivost, tresenje, mišična šibkost, vztrajno jokanje, težave pri sesanju ali motnje spanja.
English: The majority of reports were associated with older patients, and patients taking diuretics or otherwise volume depleted.
Slovenian: V večini primerov je šlo za starejše bolnike in bolnike, ki so jemali diuretike ali bili iz drugih vzrokov hipovolemični.
English: • have epilepsy or have had a fit in the past; if you have a fit (seizure) or experience an increase in seizure frequency, contact your doctor immediately, the use of fluoxetine might need to be discontinued.
Slovenian: • imate epilepsijo ali ste kdaj imeli epileptični napad; če imate napad (krč) ali se je pogostnost napadov pri vas povečala, se takoj obrnite na svojega zdravnika, morda bo potrebna prekinitev uporabe fluoksetina.
English: • Take the bottle of (Invented name)® with you if you can.
Slovenian: • Če je mogoče, vzemite s seboj steklenico (Izmišljeno ime)®.
English: - NIMH Prospective placebo-controlled study: The MAHs committed to assess the possibilities to include the evaluation of the effect of fluoxetine on sexual maturation in children aged 8 - 12
Slovenian: - Prospektivna, s placebom primerjana raziskava Nacionalnega inštituta za mentalno zdravje: Imetnik dovoljenja za promet z zdravilom je prevzel obveznost, da bo preučil možnosti za vključitev vrednotenja učinka fluoksetina na spolno dozorevanje pri otrocih, starih od 8 do 12
English: INFORMATION IN BRAILLE (Invented name)® 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI (Izmišljeno ime)® 20 mg
English: • Obsessive-compulsive disorder
Slovenian: • obsesivno-kompulzivno motnje
English: • phenytoin (for epilepsy); because (Invented name)® may influence the blood levels of this drug, your doctor may need to introduce phenytoin more carefully and carry out check-ups when given with (Invented name)®.
Slovenian: • fenitoin (za epilepsijo); ker (Izmišljeno ime)® lahko vpliva na vrednosti tega zdravila v krvi, bo ob jemanju (Izmišljeno ime)® vaš zdravnik morda previdneje uvedel fenitoin in vas naročil na redne preglede.
English: If you forget to take (Invented name)®
Slovenian: Če ste pozabili vzeti zdravilo (Izmišljeno ime)®
English: Hallucinations, manic reaction, confusion, agitation, anxiety and associated symptoms (e.g. nervousness), impaired concentration and thought process (e.g. depersonalisation), panic attacks, suicidal thoughts and behaviour (these symptoms may be due to the underlying disease), very rarely serotonin syndrome.
Slovenian: Halucinacije, manična reakcija, zmedenost, vznemirjenost, anksioznost in z njimi povezani simptomi (npr. živčnost), motnje zbranosti in miselnega procesa (npr. depersonalizacija), panični napadi, samomorilne misli in vedenje (ti simptomi se lahko pojavijo zaradi osnovne bolezni), zelo redko serotoninski sindrom.
English: • If you take too many capsules, go to your nearest hospital emergency department (or casualty)
Slovenian: • Če zaužijete preveč kapsul, pojdite na urgentni oddelek najbližje bolnišnice ali takoj sporočite svojemu zdravniku.
English: Concomitant therapy with drugs predominantly metabolised by this isoenzyme, and which have a narrow therapeutic index (such as flecainide, encainide, carbamazepine and tricyclic antidepressants), should be initiated at or adjusted to the low end of their dose range.
Slovenian: Sočasno zdravljenje z zdravili, ki se presnavljajo predvsem s tem izoencimom in imajo ozek terapevtski indeks (kot so flekainid, enkainid, karbamazepin in triciklični antidepresivi), je treba začeti z nižjimi vrednostmi razpona njihovega odmerjanja ali pa jih takšnim vrednostim prilagoditi.
English: Maximum recommended dose is 60 mg/day.
Slovenian: Najvišji priporočeni odmerek je 60 mg/dan.
English: As these syndromes may result in potentially life-threatening conditions, treatment with fluoxetine should be discontinued if such events (characterised by clusters of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma) occur and supportive symptomatic treatment should be initiated.
Slovenian: Ker ti sindromi lahko povzročijo potencialno življenjsko nevarna stanja, moramo zdravljenje s fluoksetinom ob pojavu takih dogodkov (ki jih označujejo skupki simptomov, kot so hipertermija, rigidnost, mioklonus, avtonomna labilnost z možnimi hitrimi nihanji vitalnih znakov, spremembe mentalnega stanja, vključujoč zmedenost, razdražljivost, skrajno vznemirjenost, ki napredujejo v delirij in komo) prekiniti in uvesti podporno simptomatsko zdravljenje.
English: Caution is advised in patients taking SSRI's, particularly in concomitant use with oral anticoagulants, drugs known to affect platelet function (e.g. atypical antipsychotics such as clozapine, phenothiazines, most TCA's, aspirin, NSAID's) or other drugs that may increase risk of bleeding as well as in patients with a history of bleeding disorders.
Slovenian: Pri bolnikih, ki jemljejo selektivne zaviralce prevzema serotonina je potrebna previdnost, zlasti ob sočasni uporabi peroralnih antikoagulantov, zdravil, za katere vemo, da vplivajo na delovanje trombocitov (npr. atipični antipsihotiki, kot so klozapin, fenotiazini, večina tricikličnih antidepresivov, aspirin, nesteroidna protivnetna zdravila), ali drugih zdravil, ki lahko povečajo tveganje za krvavitev, kot tudi pri bolnikih, ki imajo v anamnezi motnje strjevanja krvi.
English: • Bulimia nervosa: The recommended dose is 60 mg daily.
Slovenian: • bulimija nervoza: Priporočeni odmerek je 60 mg na dan.
English: Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Slovenian: S samomorom povezana vedenja, (poskus samomora in samomorilne misli) ter sovražnost (večinoma nasilno vedenje, nasprotovalno vedenje in jeza) so bila v kliničnih preskušanjih pogosteje opažena pri otrocih in mladostnikih, ki so bili zdravljeni z antidepresivnimi zdravili, v primerjavi s tistimi, ki so prejemali placebo.
English: Cases of overdose of fluoxetine alone usually have a mild course.
Slovenian: Primeri prevelikega odmerjanja fluoksetina samega običajno potekajo blago.
English: Dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate.
Slovenian: V 3 do 4 tednih po začetku zdravljenja ter kasneje je treba oceniti odmerjanje in ga v skladu s klinično presojo po potrebi prilagoditi.
English: If you stop taking (Invented name)®
Slovenian: Če ste prenehali jemati zdravilo (Izmišljeno ime)®
English: • Bulimia nervosa: (Invented name)® is used alongside psychotherapy for the reduction of binge eating and purging
Slovenian: • bulimije nervoze: (Izmišljeno ime)® uporabljamo v kombinaciji s psihoterapijo za zmanjševanje epizod prenajedanja in bruhanja
English: Hypersensitivity to fluoxetine or to any of the excipients.
Slovenian: Preobčutljivost za fluoksetin ali katerokoli pomožno snov.
English: Due to higher plasma levels in lower weight children, the therapeutic effect may be achieved with lower doses (see Section 5.2 Pharmacokinetic properties).
Slovenian: Pri otrocih z manjšo telesno maso lahko glede na višje vrednosti koncentracije zdravila v plazmi dosežemo terapevtski učinek že pri nižjih odmerkih (glejte poglavje 5.2 Farmakokinetične lastnosti).
English: If (Invented name)® has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor.
Slovenian: Če so vam (Izmišljeno ime)® predpisali za dolgo obdobje in/ali v visokem odmerku, naj vaš zdravnik premisli o daljšem intervalu od prenehanja jemanja MAOI.
English: Pharmaceutical grade edible printing ink components: Formulation 1:
Slovenian: Sestavine farmacevtskega užitnega tiskalnega črnila:
English: Only after one to two weeks, the dose may be increased to 20mg/day.
Slovenian: Šele po enem do dveh tednih se odmerek lahko poveča na 20 mg/dan.
English: However, the CHMP requested the MAH to undertake an additional study in young rats, to assess the neurohormonal status of hypothalamic-pituitary-gonadal (HPG) axis during sexual maturation of juvenile male and female rats.
Slovenian: Vendarle pa je CHMP od imetnika dovoljenja za promet z zdravilom zahteval, da izvede dodatno raziskavo pri mladih podganah za ocenitev nevrohormonskega statusa osi hipotalamus-hipofiza-spolne žleze (HPG) med spolnim dozorevanjem mladih podgan moškega in ženskega spola.
English: At 10 mg/kg/day, plasma levels achieved in animals were approximately 0.8 to 8.8 fold (fluoxetine) and 3.6 to 23.2 fold (norfluoxetine) those usually observed in paediatric patients.
Slovenian: Pri odmerku 10 mg/kg/dan so plazemske vrednosti pri živalih dosegle približno 0,8 do 8,8 krat (fluoksetin) oziroma 3,6 do 23,2 krat (norfluoksetin) višje vrednosti v primerjavi z vrednostmi, ki jih navadno opažamo pri pediatričnih bolnikih.
English: Fluoxetine is secreted into breast milk.
Slovenian: Fluoksetin se izloča v materino mleko.
English: Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), asthenia, agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported reactions.
Slovenian: Omotica, senzorične motnje (vključno s parestezijami), motnje spanja (vključno z nespečnostjo in intenzivnimi sanjami), astenija, agitacija ali tesnobnost, slabost in/ali bruhanje, tresenje in glavobol so reakcije, o katerih bolniki najpogosteje poročajo.
English: The black edible printing ink consists of shellac, propylene glycol, ammonium hydroxide, black iron oxide (E172) (formulation 1) or shellac, soya lecithin, antifoam DC 1510, black iron oxide (E172) (formulation 2).
Slovenian: Užitno tiskalno črnilo je iz šelaka, propilenglikola, amonijevega hidroksida, črnega železovega oksida (E172) (formulacija 1) ali šelaka, lecitina soje, sredstva proti penjenju DC 1510 in črnega železovega oksida (E172) (formulacija 2).
English: Urogenital system and reproductive disorders - difficulty passing urine or passing urine too frequently, poor sexual performance, prolonged erections, and producing breastmilk.
Slovenian: Sečila, spolovila in motnje reprodukcije - težave pri uriniranju ali pogosto uriniranje, spolna neučinkovitost, podaljšana erekcija in izločanje materinega mleka.
English: Major depressive episodes.
Slovenian: Velike depresivne epizode.