FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with Valdoxan should only be prescribed after careful consideration of benefit and risk in patients with hepatic injury risk factors e.g.:
Slovenian: Zdravljenje z zdravilom Valdoxan lahko predpišete le po skrbnem pretehtanju koristi in tveganja pri bolnikih s prisotnimi dejavniki tveganja za poškodbo jeter, kot so npr.:
English: Valdoxan is used in adults.
Slovenian: Zdravilo Valdoxan se uporablja pri odraslih.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Slovenian: Po prvi uvedbi zdravljenja z antidepresivi lahko te misli postanejo še hujše, saj ta zdravila začnejo delovati šele čez nekaj časa, običajno čez dva tedna, nekatera pa tudi pozneje.
English: In some cases, your doctor may prescribe a higher dose (50 mg), i.e. two tablets to be taken together at bedtime.
Slovenian: Nekaterim bolnikom lahko zdravnik predpiše večji odmerek (50 mg), to je dve tableti naenkrat pred spanjem.
English: - if you are taking fluvoxamine (another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic).
Slovenian: - če jemljete fluvoksamin (drugo zdravilo za zdravljenje depresije) ali ciprofloksacin (antibiotik).
English: Valdoxan film-coated tablets may be taken with or without food.
Slovenian: Filmsko obložene tablete zdravila Valdoxan lahko bolniki jemljejo s hrano ali brez nje.
English: The safety and efficacy of agomelatine in children from 2 years onwards for treatment of major depressive episodes have not yet been established.
Slovenian: Varnost in učinkovitost agomelatina pri otrocih, starejših od 2 let, pri zdravljenju velikih depresivnih epizod še nista bili dokazani.
English: If you have taken more Valdoxan than you should, or if for example a child has taken medicine by accident, contact your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Valdoxan, kot bi smeli Če ste vzeli večji odmerek zdravila Valdoxan, kot bi smeli, ali če je na primer zdravilo nehote vzel otrok, takoj obvestite svojega zdravnika.
English: ‐ the increase in serum transaminases exceeds 3 X upper limit of normal.
Slovenian: ‐ če zvišanje aminotransferaz v serumu presega 3-kratno zgornjo mejo normalnih vrednosti.
English: No effect is documented in patients ≥75 years.
Slovenian: Pri bolnikih ≥ 75 let učinka niso dokazali.
English: Agomelatine failed to differentiate from placebo in two trials where the active control, paroxetine or fluoxetine showed assay sensitivity.
Slovenian: Agomelatin se ni razlikoval od placeba v dveh preskušanjih, kjer je aktivni nadzor s paroksetinom ali fluoksetinom pokazal občutljivost analize.
English: Agomelatine inhibits neither CYP1A2 in vivo nor the other CYP450 in vitro.
Slovenian: Agomelatin ne zavira CYP1A2 in vivo niti drugih CYP450 in vitro.
English: These discontinuation symptoms may be confounded with a lack of early benefit of agomelatine.
Slovenian: Odtegnitvene simptome bi utegnili zamenjati z odsotnostjo zgodnjega koristnega učinka agomelatina.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of agomelatine in pregnant women.
Slovenian: Podatkov o uporabi agomelatina pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
English: The Marketing Authorisation Holder shall agree the format and content of the patient booklet with the National Competent Authority in the Member State.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo uskladil obliko in vsebino brošure za bolnike s pristojnim organom države članice.
English: Efficacy was also observed in more severely depressed patients (baseline HAM-D ≥ 25) in all positive placebo-controlled trials.
Slovenian: Učinkovitost so dokazali tudi pri bolnikih s hujšo depresijo (izhodiščni seštevek po Hamiltonovi ocenjevalni lestvici za depresijo ≥ 25) v vseh pozitivnih s placebom nadzorovanih preskušanjih.
English: Valdoxan is not recommended in the treatment of depression in patients under 18 years of age since safety and efficacy of Valdoxan have not been established in this age group.
Slovenian: Zdravilo Valdoxan ni priporočljivo za zdravljenje depresije pri bolnikih, ki so mlajši od 18 let, ker varnosti in učinkovitosti zdravila Valdoxan pri tej starostni skupini niso proučevali.
English: Agomelatine resynchronises circadian rhythms in animal models of circadian rhythm disruption.
Slovenian: Agomelatin resinhronizira cirkadiane ritme pri živalskih modelih desinhronizacije cirkadianega ritma.
English: Your doctor may continue to give you Valdoxan when you are feeling better to prevent your depression from returning.
Slovenian: Zdravnik vam bo morda predpisoval zdravilo Valdoxan tudi še potem, ko se boste že počutili bolje, da bi preprečil ponovitev depresije.
English: Combination with CYP1A2 inhibitors (see sections 4.3 and 4.5)
Slovenian: Kombinacija z zaviralci CYP1A2 (glejte poglavji 4.3 in 4.5)
English: A meta-analysis of placebocontrolled clinical trials 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.
Slovenian: Metaanaliza s placebom nadzorovanih kliničnih preskušanj antidepresivov pri odraslih bolnikih s psihiatričnimi motnjami je pokazala, da pri bolnikih, mlajših od 25 let, pri uporabi antidepresivov obstaja večje tveganje za pojav samomorilnega vedenja kot pri uporabi placeba.
English: In rodents, a marked induction of CYP2B and a moderate induction of CYP1A and CYP3A were seen from 125 mg/kg/day whereas in monkeys the induction was slight for CYP2B and CYP3A at 375 mg/kg/day.
Slovenian: Pri glodalcih so zasledili izrazito indukcijo CYP2B in zmerno indukcijo CYP1A in CYP3A z odmerkom 125 mg/kg/dan, medtem ko je bila pri opicah z odmerkom 375 mg/kg/dan indukcija
English: A placebo-controlled 8-week trial of agomelatine 25-50mg/day in elderly depressed patients (≥ 65 years, N=222, of which 151 on agomelatine) demonstrated a statistically significant difference of 2.67 points on HAM-D total score, the primary outcome.
Slovenian: V s placebom nadzorovanem 8-tedenskem preskušanju agomelatina v odmerku od 25 do 50 mg/dan pri starejših bolnikih z depresijo (≥ 65 let, N=222, 151 od bolnikov je prejemalo agomelatin) je bila dokazana statistično značilna razlika 2,67 točk po Hamiltonovi ocenjevalni lestvici za depresijo, kot primarni izid.
English: The Marketing Authorisation Holder shall ensure that at launch and after launch all physicians who are expected to prescribe or use Valdoxan are provided with the updated educational material containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob prihodu na trg in po prihodu na trg vsi zdravniki, ki predpisujejo ali uporabljajo zdravilo Valdoxan, prejeli posodobljeno izobraževalno gradivo, ki vsebuje naslednje:
English: If you forget to take Valdoxan
Slovenian: Če ste pozabili vzeti zdravilo Valdoxan
English: Agomelatine can be started immediately while tapering the dosage of a SSRI//SNRI (see section
Slovenian: Zdravljenje z agomelatinom lahko uvedete takoj, ko začnete z zmanjševanjem odmerka SSRI/SNRI (glejte poglavje
English: The pattern of liver damage is predominantly hepatocellular with increased serum transaminases, which usually return to normal levels on cessation of agomelatine.
Slovenian: Pojav poškodb jeter je večinoma hepatocelularen, pri čemer se zvišane aminotransferaze v serumu običajno vrnejo na normalne vrednosti ob ukinitvi agomelatina.
English: Calendar packs of 100 film-coated tablets for hospital use.
Slovenian: Koledarska pakiranja s 100 filmsko obloženimi tabletami za bolnišnično uporabo.
English: Agomelatine was not compared directly with paroxetine and fluoxetine as these comparators where added in order to ensure assay sensitivity of the trials.
Slovenian: Agomelatina niso primerjali neposredno s paroksetinom ali fluoksetinom, ker sta bili ti primerjalni zdravili dodani zaradi zagotavljanja občutljivosti analize v preskušanjih.
English: No effect of agomelatine is documented in patients ≥75 years, therefore agomelatine should not be used by patients in this age group (see also sections 4.2 and 5.1).
Slovenian: Pri bolnikih ≥ 75 let učinka agomelatina niso dokazali, zato se agomelatin pri bolnikih v tej starostni skupini ne sme uporabljati (glejte tudi poglavji 4.2 in 5.1).
English: If Valdoxan is initiated while tapering the dosage of the previous medicine, possible discontinuation symptoms should not be confounded with a lack of early effect of Valdoxan.
Slovenian: Če vam bodo zdravilo Valdoxan uvedli že v času zmanjševanja odmerka prejšnjega zdravila, možnih odtegnitvenih simptomov ne smete zamenjati z odsotnostjo zgodnjega učinka zdravila Valdoxan.
English: There is no relevant use of agomelatine in children from birth to 2 years for treatment of major depressive episodes.
Slovenian: Agomelatin ni primeren za uporabo pri otrocih, od rojstva do starosti 2 let, za zdravljenje velikih depresivnih epizod.
English: Other medicines and Valdoxan
Slovenian: Druga zdravila in zdravilo Valdoxan
English: Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.
Slovenian: Bolnike z depresijo morate zdraviti dovolj časa, to je najmanj 6 mesecev, da se zagotovi odsotnost simptomov.
English: Be vigilant about signs and symptoms that your liver may not be working properly - If you observe any of these signs and symptoms of liver problems: unusual darkening of the urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, unusual fatigue (especially associated with other symptoms listed above), seek urgent advice from a doctor who may advise you to stop taking Valdoxan.
Slovenian: Bodite pozorni na znake in simptome, ki kažejo na morebitno nepravilno delovanje vaših jeter - Če opazite katere koli znake in simptome težav z jetri: neobičajno temen urin, svetlo obarvanje blata, rumena koža/oči, bolečina v zgornjem desnem delu trebuha, neobičajna utrujenost (še posebno, če je povezana z drugimi simptomi, navedenimi zgoraj), nujno poiščite pomoč zdravnika, ki vam bo morda svetoval prenehanje zdravljenja z zdravilom Valdoxan.
English: Ethnic groups
Slovenian: Etnična pripadnost
English: Agomelatine has no abuse potential as measured in healthy volunteer studies on a specific visual analogue scale or the Addiction Research Center Inventory (ARCI) 49 check-list.
Slovenian: Agomelatin nima potenciala za zlorabo, kar so dokazali v študijah pri zdravih prostovoljcih z namensko vizualno analogno lestvico ali vprašalnikom Centra za raziskave odvisnosti (ARCI-49).
English: At higher doses, a saturation of the first-pass effect occurs.
Slovenian: Ob večjih odmerkih se pojavi zasičenost učinka prvega prehoda preko jeter.
English: Any patient who develops increased serum transaminases should have his/her liver function tests repeated within 48 hours.
Slovenian: Če pri kateremkoli bolniku opazite zvišanje aminotransferaz v serumu, je treba pregled delovanja jeter ponoviti v 48 urah.
English: Therefore, agomelatine should not be used by patients in this age group (see sections 4.4 and 5.1).
Slovenian: Agomelatin se zato v tej starostni skupini bolnikov ne sme uporabljati (glejte poglavji 4.4 in 5.1).
English: Treatment discontinuation No dosage tapering is needed on treatment discontinuation.
Slovenian: Prekinitev zdravljenja Ob prekinitvi zdravljenja odmerka ni potrebno postopoma zmanjševati.
English: Therefore, agomelatine will not modify exposure to medicinal products metabolised by CYP 450.
Slovenian: Agomelatin zato ne vpliva na izpostavljenost zdravilom, ki se presnavljajo preko CYP450.
English: During treatment transaminases should be monitored periodically after around three weeks, six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated (see also section 4.4).
Slovenian: Med zdravljenjem je treba redno spremljati vrednosti aminotransferaz, po približno 3 tednih, 6 tednih (na koncu akutne faze), 12 tednih in 24 tednih (na koncu vzdrževalne faze) ter pozneje, ko je to klinično indicirano (glejte tudi poglavje 4.4).
English: Agomelatine has shown an antidepressant-like effect in animal models of depression (learned helplessness test, despair test, chronic mild stress) as well as in models with circadian rhythm desynchronisation and in models related to stress and anxiety.
Slovenian: Agomelatin je imel antidepresivom soroden učinek pri živalskih modelih depresije (test priučene nebogljenosti, test obupanosti, kroničen blag stres), desinhronizacije cirkadianega ritma ter stresa in anksioznosti.
English: - If you have increased levels of liver enzymes before treatment, your doctor will decide if Valdoxan is right for you.
Slovenian: - Če imate pred zdravljenjem zvišane vrednosti jetrnih encimov, bo vaš zdravnik odločil, ali je zdravilo Valdoxan primerno za vas.
English: Some patients may get increased levels of liver enzymes in their blood during treatment with Valdoxan.
Slovenian: Pri nekaterih bolnikih se lahko vrednosti jetrnih encimov med jemanjem zdravila Valdoxan zvišajo.
English: Hallucinations*
Slovenian: redki halucinacije*
English: Following discontinuation of Valdoxan therapy liver function tests should be repeated until serum transaminases return to normal.
Slovenian: Po prekinitvi zdravljenja z zdravilom Valdoxan morate delovanje jeter pregledovati dokler se aminotransferaze v serumu ne vrnejo na normalne vrednosti.
English: Adverse reactions are listed below using the following convention: very common (≥1/10); common (≥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, < 1/10),
English: It is not known whether agomelatine/metabolites are excreted in human milk.
Slovenian: Dojenje Ni znano, ali se agomelatin/presnovki izločajo v materino mleko.
English: INFORMATION IN BRAILLE Valdoxan 25 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Valdoxan 25 mg
English: The recommended dose is 25 mg once daily taken orally at bedtime.
Slovenian: Odmerjanje Priporočeni odmerek je 25 mg enkrat na dan peroralno pred spanjem.
English: 5 How to store Valdoxan Contents of the pack and other information
Slovenian: Shranjevanje zdravila Valdoxan Vsebina pakiranja in dodatne informacije
English: Valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting treatment.
Slovenian: Pri večini bolnikov zdravilo Valdoxan začne zmanjševati simptome depresije v dveh tednih po začetku zdravljenja.
English: Valdoxan should not be used for the treatment of major depressive episodes in elderly patients with dementia since the safety and efficacy of Valdoxan have not been established in these patients.
Slovenian: Uporaba pri starejših z demenco Zdravila Valdoxan ne smete predpisovati za zdravljenje velikih depresivnih epizod pri starejših bolnikih z demenco, ker varnosti in učinkovitosti zdravila Valdoxan pri tovrstnih bolnikih niso proučevali.
English: The variability is increased with high fat food.
Slovenian: Ob živilih z veliko maščobami se zveča variabilnost.
English: If your doctor changes your previous antidepressant medicine from an SSRI or SNRI to Valdoxan, he/she will advise you on how you should discontinue your previous medicine when starting Valdoxan.
Slovenian: Če vam bo zdravnik zamenjal vaš prejšnji antidepresiv iz skupine SSRI ali SNRI z zdravilom Valdoxan, vam bo ob uvedbi zdravila Valdoxan svetoval o ustreznem načinu prenehanja zdravljenja s prejšnjim zdravilom.
English: Increased ALT and/or AST (in clinical trials, increases >3 times the upper limit of the normal range for ALT and/or AST were seen in 1.2% of patients on agomelatine 25 mg daily and 2.6 % on agomelatine 50 mg daily vs. 0.5% on placebo).
Slovenian: Bolezni jeter, žolčnika in žolčevodov pogosti zvišani ALT in/ali AST (v kliničnih preskušanjih so zvišanja za > 3-kratno zgornjo mejo normalnih vrednosti ALT in/ali AST opazili pri 1,2 % bolnikov, zdravljenih s 25 mg agomelatina, ter 2,6 % bolnikov, zdravljenih s 50 mg agomelatina, v primerjavi z 0,5 % bolnikov, ki so prejemali placebo)
English: No improvement was observed in very elderly patients (≥75 years, N= 69, of which 48 on agomelatine).
Slovenian: Pri najstarejših bolnikih (≥ 75 let, N=69, 48 od bolnikov je prejemalo agomelatin) ni bilo opaznega izboljšanja.
English: - obesity/overweight/non-alcoholic fatty liver disease, diabetes
Slovenian: - debelost/prekomerna telesna masa/zamaščenost jeter nealkoholnega izvora, sladkorna bolezen,
English: The symptoms of depression vary from one person to another, but often include deep sadness, feelings of worthlessness, loss of interest in favourite activities, sleep disturbances, feeling of being slowed down, feelings of anxiety, changes in weight.
Slovenian: Simptomi depresije se razlikujejo od bolnika do bolnika, pogosto pa zajemajo globoko žalost, občutek ničvrednosti, izgubo zanimanja za priljubljene dejavnosti, motnje spanja, občutek upočasnjenosti, občutek tesnobe in spremembe telesne mase.
English: After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime.
Slovenian: Če se simptomi ne izboljšajo, lahko po 2 tednih zdravljenja odmerek zvečate na 50 mg enkrat na dan,
English: In depressed patients, treatment with agomelatine 25 mg increased slow wave sleep without modification of REM (Rapid Eye Movement) sleep amount or REM latency.
Slovenian: Pri bolnikih z depresijo je zdravljenje z agomelatinom v odmerku 25 mg podaljšalo spanje s počasnimi valovi, brez vpliva na fazo spanja REM (Rapid Eye Movement) ali na čas do njenega nastopa.
English: Binding studies indicate that agomelatine has no effect on monoamine uptake and no affinity for α, β adrenergic, histaminergic, cholinergic, dopaminergic and benzodiazepine receptors.
Slovenian: Študije o vezavi so pokazale, da agomelatin nima učinka na privzem monoaminov niti afinitete za α-adrenergične, β-adrenergične, histaminske, holinergične, dopaminergične ali benzodiazepinske receptorje.
English: Effect of Valdoxan is not documented in patients aged 75 years and older.
Slovenian: Učinka zdravila Valdoxan pri bolnikih starih 75 let in več niso dokazali.
English: The below table gives the adverse reactions observed from placebo-controlled and active-controlled clinical trials.
Slovenian: V spodnji preglednici so navedeni neželeni učinki, ki so jih opažali v kliničnih preskušanjih, nadzorovanih s placebom ali učinkovino.
English: Caution should be exercised before starting treatment and close surveillance should be performed throughout the treatment period in all patients, especially if hepatic injury risk factors or concomitant medicinal products associated with risk of hepatic injury are present.
Slovenian: Pred uvedbo zdravljenja je potrebna previdnost, med zdravljenjem pa morate posebej skrbno nadzirati vse bolnike, zlasti tiste, ki imajo prisotne dejavnike tveganja za poškodbo jeter ali sočasno jemljejo zdravila, ki jih spremlja tveganje za poškodbe jeter.
English: Agomelatine passes into the placenta and foetuses of pregnant rats.
Slovenian: Agomelatin prehaja v placento in fetuse pri brejih podganah.
English: You might experience dizziness or sleepiness which could affect your ability to drive or operate machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Morda boste občutili omotico ali zaspanost, ki lahko vplivata na vašo sposobnost upravljanja vozil in strojev.
English: Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine.
Slovenian: Zdravila, ki medsebojno delujejo z naštetimi izoencimi, lahko zvečujejo ali zmanjšujejo biološko uporabnost agomelatina.
English: No effect of agomelatine on juvenile animals behavioural performances, visual and reproductive function were observed.
Slovenian: Vpliva agomelatina na vedenjsko sposobnost, vidno in razmnoževalno funkcijo pri živalih v juvenilnem obdobju niso opazili.
English: Responder rate analysis favoured agomelatine.
Slovenian: Analiza stopenj odziva je pokazala prednost agomelatina.
English: Valdoxan with alcohol
Slovenian: Zdravilo Valdoxan skupaj z alkoholom
English: Hepatic impairment Agomelatine is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Slovenian: Agomelatin je pri bolnikih z jetrno okvaro kontraindiciran (glejte poglavja 4.3, 4.4 in 5.2).
English: • lactose monohydrate, maize starch, povidone (K30), sodium starch glycolate type A, stearic acid, magnesium stearate, colloidal anhydrous silica,hypromellose, glycerol, macrogol (6000), yellow iron oxide (E172) and titanium dioxide (E171).
Slovenian: - Pomožne snovi so: - laktoza monohidrat, koruzni škrob, povidon (K30), natrijev karboksimetilškrob (vrsta A), stearinska kislina, magnezijev stearat, brezvoden koloidni silicijev dioksid, hipromeloza, glicerol, makrogol (6000), rumeni železov oksid (E172) in titanov dioksid (E171);
English: While there was no specific safety signal in the 800 patients treated in combination with oestrogens, caution should be exercised when prescribing agomelatine with other moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) until more experience has been gained (see section 4.4).
Slovenian: Čeprav pri 800 bolnikih, ki so sočasno jemali estrogene, niso zasledili specifičnih varnostnih opozoril, morate biti previdni, ko predpisujete agomelatin z drugimi zmernimi zaviralci CYP1A2 (npr. propranololom, enoksacinom), dokler ne bo na voljo več izkušenj
English: No evidence of pharmacokinetic or pharmacodynamic interaction with medicinal products which could be prescribed concomitantly with Valdoxan in the target population was found in phase I clinical trials: benzodiazepines, lithium, paroxetine, fluconazole and theophylline.
Slovenian: V kliničnih preskušanjih faze I niso opazili dokazov o farmakokinetičnem ali famakodinamičnem medsebojnem delovanju zdravila Valdoxan z zdravili, ki jih sočasno predpisujemo pri ciljni skupini bolnikov: benzodiazepini, litijem, paroksetinom, flukonazolom in teofilinom.
English: Weight decreased* * Frequency estimated from clinical trials for adverse reactions detected from spontaneous report (1) Few cases were exceptionally reported with fatal outcome or liver transplantation in patients with hepatic risk factors.
Slovenian: *frekvenca neželenih učinkov spontanih poročil ocenjena na podlagi kliničnih preskušanj (1) pri bolnikih s prisotnimi dejavniki tveganja za poškodbo jeter so izjemoma poročali o nekaj primerih s smrtnim izidom ali transplantacijo jeter.
English: Do not take Valdoxan - if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Valdoxan Ne jemljite zdravila Valdoxan - če ste alergični na agomelatin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: Valdoxan is indicated for the treatment of major depressive episodes in adults.
Slovenian: 4.1 Terapevtske indikacije Zdravilo Valdoxan je indicirano za zdravljenje velikih depresivnih epizod pri odraslih.
English: Each film-coated tablet contains 25 mg of agomelatine.
Slovenian: Ena filmsko obložena tableta vsebuje 25 mg agomelatina.
English: In vivo, agomelatine does not induce CYP450 isoenzymes.
Slovenian: In vivo, agomelatin ne spodbuja izoencimov CYP450.
English: Primary endpoint was change in HAMD-17 score from baseline.
Slovenian: Primarni izid je bila sprememba izhodiščnega seštevka po Hamiltonovi ocenjevalni lestvici za depresijo HAMD-17.
English: Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility, embryofoetal development and pre- and post natal development.
Slovenian: Študije o razmnoževanju pri podganah in kuncih niso pokazale učinka agomelatina na plodnost, razvoj zarodka ali ploda in predporodni ter poporodni razvoj.