FrancophonIA/ELRC3.0 huggingface dataset:
English: When treatment was switched from these antidepressants to agomelatine, discontinuation symptoms arose after cessation of the SSRI or SNRI treatment, either after abrupt cessation or gradual cessation of the previous treatment.
Slovenian: Ob menjavi zdravljenja z omenjenih antidepresivov na agomelatin, so se po prenehanju zdravljenja s SSRI ali SNRI pojavili odtegnitveni simptomi, ki so se pojavili bodisi po nenadnem bodisi po postopnem prenehanju zdravljenja s prejšnjim zdravilom.
English: Confusional state*
Slovenian: stanje zmedenosti*
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Spremljanje delovanja jeter
English: Agomelatine 25 mg also induced an advance of the time of sleep onset and of minimum heart rate.
Slovenian: Agomelatin v odmerku 25 mg je tudi premaknil nastop spanja in najmanjše srčne frekvence na zgodnejšo uro.
English: Superiority (2 trials) or non-inferiority (4 trials) has been shown in six out of seven efficacy trials in heterogeneous populations of depressed adult patients versus SSRI/SNRI (sertraline, escitalopram, fluoxetine, venlafaxine or duloxetine) The anti-depressive effect was assessed with the HAMD-17 score either as primary or secondary endpoint.
Slovenian: Superiornost (2 preskušanji) ali neinferiornost (4 preskušanja) napram SSRI/SNRI (setralinu, escitalopramu, fluoksetinu, venlafaksinu ali duloksetinu) je bila dokazana v šestih od sedmih preskušanj učinkovitosti v heterogeni populaciji odraslih bolnikov z depresijo.
English: In a specific sexual dysfunction comparative trial with remitted depressed patients, there was a numerical trend (not statistically significant) towards less sexual emergent dysfunction than venlafaxine for Sex Effects Scale (SEXFX) drive arousal or orgasm scores on agomelatine.
Slovenian: Pri bolnikih z remisijo depresije je specifično primerjalno preskušanje o spolni disfunkciji pokazala težnjo, ki sicer ni bila statistično značilna, k manjšemu številu novonastalih spolnih motenj pri agomelatinu v primerjavi z venlafaksinom pri seštevkih točk, povezanih z libidom, vzburjenjem in orgazmi, merjenih po lestvici spolnih učinkov (SEXFX - Sex Effects Scale).
English: Ten placebo controlled trials have been performed to investigate the short term efficacy of agomelatine in major depressive disorder in adults, with fixed dose and/or dose up-titration.
Slovenian: Da bi proučili kratkoročno učinkovitost agomelatina pri velikih depresivnih epizodah, so izvedli deset s placebom nadzorovanih preskušanj pri odraslih, s stalnimi odmerki in/ali povečevanjem odmerka.
English: Baseline liver function tests should be undertaken in all patients and treatment should not be initiated in patients with baseline values of ALT and/or AST >3 X upper limit of normal (see section 4.3).
Slovenian: Pred začetkom zdravljenja je treba pri vseh bolnikih pregledati delovanje jeter, zdravljenja pa ne smete uvesti bolnikom z izhodiščnimi vrednostmi ALT in/ali AST > 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavje 4.3).
English: A battery of in vitro and in vivo standard genotoxicity assays concludes to no mutagenic or clastogenic potential of agomelatine.
Slovenian: Serija standardnih genotoksičnih analiz in vitro ter in vivo je dokazala, da agomelatin nima mutagenega ali klastogenega potenciala.
English: The Summary of Product Characteristics;
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Smoking induces CYP1A2 and has been shown to decrease the bioavailability of agomelatine, especially in heavy smokers (> 15 cigarettes/day) (see section 5.2).
Slovenian: Pokazali so, da zmanjša biološko uporabnost agomelatina, še posebno pri težkih kadilcih (≥ 15 cigaret/dan) (glejte poglavje 5.2).
English: In a trial designed to assess discontinuation symptoms by the Discontinuation Emergent Signs and Symptoms (DESS) check-list in patients with remitted depression, agomelatine did not induce discontinuation syndrome after abrupt treatment cessation.
Slovenian: (DESS - Discontinuation Emergent Signs and Symptoms) ocenjevali odtegnitvene simptome pri bolnikih z remisijo depresije, agomelatin ni povzročal odtegnitvenega sindroma po nenadni prekinitvi zdravljenja.
English: What Valdoxan contains - The active substance is agomelatine.
Slovenian: Kaj vsebuje zdravilo Valdoxan - Učinkovina je agomelatin.
English: - When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.
Slovenian: - Ob povečanju odmerka je treba jetrne teste znova izvajati v enakih razmakih kot ob uvedbi zdravljenja.
English: (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: občasni (≥ 1/1.000, < 1/100), redki (≥ 1/10.000, < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of agomelatine/metabolites in milk (see section 5.3).
Slovenian: toksikološki podatki pri živalih kažejo na izločanje agomelatina/presnovkov v mleko (glejte poglavje 5.3).
English: Rifampicin an inducer of all three cytochromes involved in the metabolism of agomelatine may decrease the bioavailability of agomelatine.
Slovenian: Rifampicin kot spodbujevalec vseh treh citokromov, ki so vpleteni v presnovo agomelatina, lahko zmanjša biološko uporabnost agomelatina.
English: Hepatic impairment (i.e. cirrhosis or active liver disease) or transaminases exceeding 3 X upper limit of normal (see sections 4.2 and 4.4).
Slovenian: Jetrna okvara (na primer ciroza ali aktivna bolezen jeter) ali zvišanje aminotransferaz nad 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavji 4.2 in 4.4).
English: Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure.
Slovenian: Fluvoksamin, močan zaviralec CYP1A2 in zmeren zaviralec CYP2C9, izrazito zavira presnovo agomelatina, zaradi česar se izpostavljenost agomelatinu zveča za 60-krat (razpon: 12-krat do
English: Your doctor will run laboratory tests to check that your liver is working properly before starting treatment and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks.
Slovenian: Spremljanje delovanja jeter (glejte tudi poglavje 2) Zdravnik bo opravil laboratorijske preiskave, da bi preveril, ali jetra delujejo pravilno, in sicer pred uvedbo zdravljenja ter redno med njim, običajno po 3 tednih, 6 tednih, 12 tednih in 24 tednih.
English: The Physician's guide to prescribing, including a liver monitoring scheme.
Slovenian: • povzetek glavnih značilnosti zdravila; • priročnik o predpisovanju za zdravnike, vključno s shemo spremljanja delovanja jeter.
English: When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.
Slovenian: Ob povečanju odmerka je treba jetrne teste spet izvajati v enakih razmakih kot ob uvedbi zdravljenja.
English: The percentage of patients with at least one discontinuation symptom one week after the SSRI/SNRI treatment stop, was lower in the long tapering group (gradual cessation of the previous SSRI/SNRI within 2 weeks) than in the short tapering group (gradual cessation of the previous SSRI/SNRI within 1 week) and in the abrupt substitution group (abrupt cessation): 56.1%, 62.6 % and 79.8% respectively.
Slovenian: (postopno prenehanje predhodnega zdravljenja s SSRI/SNRI v 2 tednih) v primerjavi s skupino s hitrim zmanjševanjem odmerka (62,6 %) (postopno prenehanje predhodnega zdravljenja s SSRI/SNRI v 1 tednu) in v primerjavi s skupino z nenadno menjavo zdravila (79,8 %) (nenadno prenehanje predhodnega zdravljenja).
English: Valdoxan should be used with caution in patients with a history of bipolar disorder, mania or hypomania and should be discontinued if a patient develops manic symptoms (see section 4.8).
Slovenian: Bipolarna motnja / manija / hipomanija Pri bolnikih z bipolarno motnjo, manijo ali hipomanijo v anamnezi morate zdravilo Valdoxan uporabljati previdno in zdravljenje prekiniti, če se pri bolniku razvijejo simptomi manije (glejte poglavje 4.8).
English: Anxiety Abnormal dreams*
Slovenian: Psihiatrične motnje pogosti anksioznost nenormalne sanje*
English: The most common adverse reactions were headache, nausea and dizziness.
Slovenian: Najpogostejši neželeni učinki so bili glavobol, navzea in omotica.
English: If you have any further questions on the use of this product, please ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom ali farmacevtom.
English: In two other trials, it was not possible to draw any conclusions because the active controls, paroxetine or fluoxetine, failed to differentiate from placebo.
Slovenian: V drugih dveh preskušanjih ni bilo mogoče postaviti zaključkov, ker se od skupine, ki je prejemala placebo, nista razlikovali skupini, ki sta prejemali paroksetin ali fluoksetin.
English: In a specific study involving cirrhotic patients with chronic mild (Child-Pugh type A) or moderate (Child-Pugh type B) liver impairment, exposure to agomelatine 25 mg was substantially increased (70times and 140-times, respectively), compared to matched volunteers (age, weight and smoking habit) with no liver failure (see section 4.2, 4.3 and 4.4).
Slovenian: (Child-Pughov tip B) jetrno okvaro se je izpostavljenost agomelatinu po odmerku 25 mg zelo zvečala (70-krat oziroma 140-krat) v primerjavi s prostovoljci brez jetrne okvare, ki so bolnikom ustrezali glede starosti, telesne mase in navad kajenja (glejte poglavja 4.2, 4.3 in 4.4).
English: - Uncommon side effects (may affect up to 1 in 100 people): migraine, pins and needles in the fingers and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder that is characterized by an uncontrollable urge to move the legs), ringing in the ears, excessive sweating (hyperhidrosis), eczema, pruritus, urticaria (hives), agitation, irritability, restlessness, aggressive behaviour, nightmares, mania/hypomania (see also under “Warnings and precautions” in section 2), suicidal thoughts or behaviour,confusion, weight decreased.
Slovenian: mravljinčenje in zbadanje v prstih na rokah ter nogah (parestezije), zamegljen vid, sindrom nemirnih nog (motnja za katero je značilna nenadzorovana nuja po premikanju nog), zvonjenje v ušesih, prekomerno znojenje (hiperhidroza), ekcemi, srbenje, urtikarija (koprivnica), vznemirjenost, razdraženost, nemir, napadalno vedenje, nočne more, manija/hipomanija (glejte tudi »Opozorila in previdnostni ukrepi« v poglavju 2), razmišljanje o samomoru in samomorilno obnašanje, zmedenost, zmanjšanje telesne mase.
English: Switching therapy from SSRI/SNRI antidepressant to agomelatine Patients may experience discontinuation symptoms after cessation from an SSRI/ SNRI antidepressant.
Slovenian: Menjava zdravljenja s SSRI/SNRI na agomelatin Po prenehanju zdravljenja z antidepresivom iz skupine SSRI/SNRI se lahko pri bolnikih pojavijo odtegnitveni simptomi.
English: Valdoxan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Slovenian: Zdravilo Valdoxan vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
English: Discontinuation symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking.
Slovenian: Odtegnitveni simptomi vključujejo: omotico, odrevenelost, motnje spanja, vznemirjenost ali anksioznost, glavobole, siljenje na bruhanje, bruhanje in tresavico.
English: The frequency of benign mammary fibroadenomas observed in the rat was increased with high exposures (60-fold the exposure at the therapeutic dose) but remains in the range of that of controls.
Slovenian: Ob veliki izpostavljenosti (60-krat večji kot ob terapevtskem odmerku) se je pogostnost benignih mamarnih fibroadenomov pri podganah zvečala, vendar je ostala v enakem razponu kot pri kontrolni skupini.
English: Erythematous rash Face oedema and angioedema*
Slovenian: redki eritematozni izpuščaj edem obraza in angioedem*
English: Each film-coated tablet contains 61.8 mg lactose (as monohydrate) For the full list of excipients, see section 6.1.
Slovenian: Ena filmsko obložena tableta vsebuje 61,8 mg laktoze (v obliki monohidrata).
English: The experience of overdoses with Valdoxan is limited but reported symptoms include pain in the upper part of the stomach, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise.
Slovenian: Izkušnje s prevelikim odmerjanjem zdravila Valdoxan so omejene, poročali pa so o simptomih, kot so bolečine v zgornjem delu želodca, zaspanost, utrujenost, razdraženost, zaskrbljenost, napetost, omotica, cianoza in občutek slabosti.
English: Electroconvulsive therapy (ECT)
Slovenian: Elektrokonvulzivno zdravljenje
English: Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.
Slovenian: Pri bolnikih z depresijo in/ali anksiozno motnjo se občasno lahko pojavijo misli na samopoškodovanje ali samomor.
English: Agomelatine had neutral effect on heart rate and blood pressure in clinical trials.
Slovenian: V kliničnih preskušanjih agomelatin ni imel vpliva na srčno frekvenco in krvni tlak.
English: Treatment should be discontinued if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4).
Slovenian: Zdravljenje morate prekiniti, če vrednosti aminotransferaz presegajo 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavji 4.3 in 4.4).
English: Printing ink containing shellac, propylene glycol and indigo carmine aluminium lake (E132).
Slovenian: Črnilo vsebuje šelak, propilenglikol in indigotin (E132).
English: How to take Valdoxan
Slovenian: Kako jemati zdravilo Valdoxan
English: LIST OF EXCIPIENTS Contains lactose.
Slovenian: SEZNAM POMOŽNIH SNOVI Zdravilo vsebuje laktozo.
English: Make sure to tell your doctor if you are taking any of the following medicines: propranolol (a beta-blocker used in the treatment of hypertension), enoxacin (antibiotic) Make sure to tell your doctor if you are smoking more than15 cigarettes/day.
Slovenian: Svojega zdravnika morate obvestiti, če jemljete katero od naslednjih zdravil: propranolol (beta blokator, ki se uporablja za zdravljenje visokega krvnega tlaka), enoksacin (antibiotik).
English: Treatment should not be initiated if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4).
Slovenian: Zdravljenja ne smete uvesti, če vrednosti aminotransferaz presegajo 3-kratno zgornjo mejo normalnih vrednosti (glejte poglavji 4.3 in 4.4).
English: Caution should be exercised when Valdoxan is administered to patients with pretreatment elevated transaminases (> the upper limit of the normal ranges and ≤3 times the upper limit of the normal range).
Slovenian: • Previdnost je potrebna pri predpisovanju bolnikom z zvišanimi vrednostmi aminotransferaz pred zdravljenjem (> zgornjo mejo normalnih vrednosti in ≤ 3-kratno zgornjo mejo normalnih vrednosti);
English: Cases of liver injury, including hepatic failure (few cases were exceptionally reported with fatal outcome or liver transplantation in patients with hepatic risk factors), elevations of liver enzymes exceeding 10 times upper limit of normal, hepatitis and jaundice have been reported in patients treated with agomelatine in the post-marketing setting (see section 4.8).
Slovenian: V času po prihodu zdravila na trg so pri bolnikih, zdravljenih z agomelatinom, poročali o primerih poškodb jeter, vključno z odpovedjo jeter (pri bolnikih s prisotnimi dejavniki tveganja za poškodbo jeter so izjemoma poročali o nekaj primerih s smrtnim izidom ali transplantacijo jeter), zvišanjih jetrnih encimov nad 10-kratno zgornjo mejo normalnih vrednosti, hepatitisu in zlatenici (glejte poglavje 4.8).
English: Safety pharmacology studies showed no effect of agomelatine on hERG (human Ether à-go-go Related Gene) current or on dog Purkinje cells action potential.
Slovenian: Farmakološke študije o varnosti niso pokazale učinka agomelatina na hERG (human Ether à-go-go
English: Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) (see section 4.5).
Slovenian: Sočasno jemanje močnih zaviralcev CYP1A2 (npr. fluvoksamin in ciprofloksacin) (glejte poglavje
English: Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold increased exposure of agomelatine.
Slovenian: Sočasno predpisovanje agomelatina z estrogeni, zmernimi zaviralci CYP1A2, privede do večkratnega zvečanja izpostavljenosti agomelatinu.
English: Film-coating
Slovenian: Način jemanja
English: Valdoxan contains lactose.
Slovenian: Zdravilo Valdoxan vsebuje laktozo.
English: Hyperhidrosis Eczema Pruritus* Urticaria*
Slovenian: Bolezni kože in podkožja občasni prekomerno znojenje ekcem pruritus* urtikarija*
English: Level of sodium
Slovenian: Vrednost natrija
English: Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
Slovenian: Sočasno jemanje agomelatina z močnimi zaviralci CYP1A2 (npr. fluvoksaminom in ciprofloksacinom) je zato kontraindicirano.
English: Caution should be exercised when prescribing Valdoxan with moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) which may result in increased exposure of agomelatine.
Slovenian: Pri sočasnem predpisovanju zdravila Valdoxan z zmernimi zaviralci CYP1A2 (npr. propranololom, enoksacinom) morate biti previdni, saj se lahko zveča izpostavljenost agomelatinu.
English: Macrogol (6000) Magnesium stearate Titanium dioxide (E171)
Slovenian: Filmska obloga - hipromeloza - rumeni železov oksid (E172) - glicerol - makrogol (6000) - magnezijev stearat - titanov dioksid (E171)
English: You may experience discontinuation symptoms related to stopping of your previous medicine for a few weeks, even if the dose of your previous antidepressant medicine is decreased gradually.
Slovenian: Kljub postopnemu zmanjševanju odmerka prejšnjega antidepresiva se pri vas lahko pojavijo nekaj tednov trajajoči neželeni učinki, ki so posledica prenehanja predhodnega zdravljenja.
English: The Marketing Authorisation Holder shall agree the format and content of the physician's guide to prescribing with the National Competent Authority prior to launch in the Member State.
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Imetnik dovoljenja za promet z zdravilom se bo z nacionalnim pristojnim organom, preden da zdravilo v promet v državi članici, dogovoril o obliki in vsebini priročnika o predpisovanju za zdravnike.
English: There were mild non dose dependent decreases in body weight related to the pharmacological properties and some minor effects on male reproductive tract without any impairment on reproductive performances.
Slovenian: povezanih s farmakološkimi lastnostmi, in nekaj manjših učinkov na reproduktivni trakt pri samcih,
English: 7 MARKETING AUTHORISATION HOLDER
Slovenian: IMETNIK DOVOLJENJA ZA PROMET
English: Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility (see section
Slovenian: Študije o razmnoževanju na podganah in kuncih niso pokazale nikakršnega učinka agomelatina na plodnost (glejte poglavje 5.3).
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: It is not advisable to drink alcohol while you are being treated with Valdoxan.
Slovenian: Med zdravljenjem z zdravilom Valdoxan ni priporočljivo piti alkohola.
English: However, only limited clinical data on the use of agomelatine in depressed patients with severe or moderate renal impairment with major depressive episodes is available.
Slovenian: Klinični podatki o predpisovanju agomelatina pri bolnikih z depresijo in hudo ali zmerno ledvično okvaro pa so omejeni, zato morate biti pri predpisovanju agomelatina tem bolnikom previdni.
English: Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/19 (10%).
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Možna medsebojna delovanja, ki vplivajo na agomelatin Agomelatin se presnavlja predvsem preko citokroma P450 1A2 (CYP1A2) (90 %) in CYP2C9/19
English: Akathisia*
Slovenian: redki akatizija*
English: Valdoxan contains lactose
Slovenian: Zdravilo Valdoxan vsebuje laktozo
English: Diarrhoea Constipation Abdominal pain Vomiting*
Slovenian: Bolezni prebavil pogosti navzea diareja zaprtje bolečine v trebuhu bruhanje*
English: - If you are diabetic, ask your doctor for advice.
Slovenian: - Če imate sladkorno bolezen, se posvetujte s svojim zdravnikom.
English: - if you are a young adult.
Slovenian: - če ste že kdaj razmišljali o samomoru ali samopoškodovanju; - če ste mlajša odrasla oseba.
English: - If you are suffering from dementia, your doctor will make an individual evaluation of whether it is right for you to take Valdoxan.
Slovenian: - Če imate demenco, bo vaš zdravnik individualno presodil, ali je za vas zdravljenje z zdravilom
English: on one side.
Slovenian: (logotip podjetja) na eni strani.
English: 4.7 Effects on ability to drive and use machines Agomelatine has minor influence on the ability to drive and use machines.Considering that dizziness and somnolence are common adverse reactions, patients should be cautioned about their ability to drive or operate machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Agomelatin ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: • printing ink : shellac, propylene glycol and indigo carmine aluminium lake (E132)
Slovenian: - črnilo: šelak, propilenglikol in indigotin (E132).
English: Blood tests
Slovenian: Laboratorijske preiskave
English: If you have trouble with your kidneys, your doctor will make an individual evaluation of whether it is safe for you to take Valdoxan.
Slovenian: Če imate težave z ledvicami, bo zdravnik individualno presodil, ali je za vas zdravljenje z zdravilom
English: (>3 times the upper limit of the normal range) Hepatic failure*(1)
Slovenian: redki hepatitis zvišana alkalna fosfataza* (> 3-kratno zgornjo mejo normalnih vrednosti) odpoved jeter*(1) zlatenica*
English: • Information about the risk of hepatic reactions and clinical signs of liver problems
Slovenian: Brošura za bolnike mora vsebovati naslednja ključna sporočila: • informacije o tveganju za jetrne reakcije in o kliničnih znakih težav z jetri
English: During treatment period Valdoxan treatment should be discontinued immediately if: ‐ patient develops symptoms or signs of potential liver injury (such as dark urine, light coloured stools, yellow skin/eyes, pain in the upper right belly, sustained new-onset and unexplained fatigue).
Slovenian: Med zdravljenjem Zdravljenje z zdravilom Valdoxan je treba takoj prekiniti: ‐ če se pri bolniku pojavijo simptomi ali znaki možne poškodbe jeter (kot je temen urin,
English: Warnings and precautions There could be some reasons why Valdoxan may not be suitable for you:
Slovenian: V nekaterih primerih zdravilo Valdoxan ni primerno za vas:
English: Les Laboratoires Servier Tel: +33 (0)1 55 72 60 00
Slovenian: Tel: +33 (0)1 55 72 60 00
English: Valdoxan is for oral use.
Slovenian: Valdoxan primerno.
English: A specific controlled, 3-week trial has been conducted in patients suffering from major depressive disorder and insufficiently improved with paroxetine (a SSRI) or venlafaxine (a SNRI).
Slovenian: Bolniki z veliko depresivno epizodo, pri katerih zdravljenje s paroksetinom (SSRI) ali venlafaksinom
English: The recommended dose of Valdoxan is one tablet (25 mg) at bedtime.
Slovenian: Običajen odmerek je ena tableta (25 mg) zdravila Valdoxan pred spanjem.
English: Agitation and related symptoms* (such as irritability and restlessness) Aggression*
Slovenian: občasni razmišljanje o samomoru ali samomorilno obnašanje (glejte poglavje 4.4) agitacija in z njo povezani simptomi* (kot sta razdražljivost in vznemirjenost) napadalnost*