FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment discontinuation No dosage tapering is needed on treatment discontinuation.
Croatian: Nije potrebno postupno smanjivati dozu pri prekidu liječenja.
English: The Physician's guide to prescribing, including a liver monitoring scheme.
Croatian: • Vodič za liječnike za propisivanje lijeka, uključujući način praćenja jetrenih enzima.
English: Patients responding to 8/10-weeks of acute treatment with open-label agomelatine 25-50 mg once daily were randomised to either agomelatine 25-50 mg once daily or placebo for further 6-months.
Croatian: Bolesnici koji su reagirali na 8/10-tjedno akutno liječenje u otvorenom ispitivanju s agomelatinom 2550 mg jednom dnevno, randomizirani su na 25-50 mg agomelatina jednom dnevno ili istu dozu placeba sljedećih 6 mjeseci.
English: 3 years.
Croatian: Nakon približno 3 tjedna
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.
Croatian: Ako imate probleme s bubrezima, liječnik će napraviti individualnu procjenu da li je za Vas sigurno uzimati Valdoxan.
English: INFORMATION IN BRAILLE Valdoxan 25 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Valdoxan 25 mg
English: The recommended dose of Valdoxan is one tablet (25 mg) at bedtime.
Croatian: Preporučena doza lijeka Valdoxan je jedna tableta (25 mg) navečer prije spavanja.
English: • printing ink : shellac, propylene glycol and indigo carmine aluminium lake (E132)
Croatian: • tinta za označavanje: šelak, propilenglikol i indigo carmine aluminium lake (E132).
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.
Croatian: Ispitivanje reakcije vezanja ukazuju na to da agomelatin ne utječe na pohranu monoamina i nema afiniteta za α- i β-adrenoreceptore, histaminergične, kolinergične, dopaminergične te benzodiazepinske receptore.
English: • A blood tests appointments reminder.
Croatian: • podsjetnik za datume kada je potrebno napraviti krvne pretrage
English: Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes.
Croatian: Kod primjene ovog lijeka potrebno je pažljivo promatrati bolesnike, posebno one visokorizične, naročito u vrijeme početka liječenja i kod promjena doze.
English: Printing ink containing shellac, propylene glycol and indigo carmine aluminium lake (E132).
Croatian: Tinta za označavanje sadrži šelak, propilenglikol i indigo carmine aluminium lake (E132).
English: ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Valdoxan 25 mg film-coated tablets are available in calendar blisters.
Croatian: Valdoxan 25 mg filmom obložene tablete dostupne su u kalendarskim blisterima.
English: Valdoxan is indicated for the treatment of major depressive episodes in adults.
Croatian: 4.1 Terapijske indikacije Valdoxan je indiciran za liječenje velikih depresivnih epizoda u odraslih.
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.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će usuglasiti oblik i sadržaj vodiča za propisivanje lijeka za liječnike s nadležnim nacionalnim tijelom prije stavljanja lijeka u promet u zemlji članici.
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.
Croatian: Dokazana je superiornost (2 ispitivanja) ili neinferiornost (4 ispitivanja) u šest od sedam ispitivanja djelotvornosti na heterogenoj populaciji odraslih bolesnika s depresijom u odnosu na SSRI / SNRI (sertralin, escitalopram, fluoksetin, venlafaksin ili duloksetin).
English: These discontinuation symptoms may be confounded with a lack of early benefit of agomelatine.
Croatian: Ovi simptomi povezani s prestankom primjene mogu se zamijeniti s nedostatkom rane koristi agomelatina.
English: Some patients may get increased levels of liver enzymes in their blood during treatment with Valdoxan.
Croatian: Kod nekih bolesnika tijekom liječenja lijekom Valdoxan može se povećati razina jetrenih enzima u krvi.
English: Anxiety Abnormal dreams*
Croatian: Anksioznost Abnormalni snovi*
English: Therefore, agomelatine should not be used by patients in this age group (see sections 4.4 and 5.1).
Croatian: Shodno tome, agomelatin se ne smije koristiti u ovoj dobnoj skupini (vidjeti dijelove 4.4 i 5.1).
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).
Croatian: Oštećenje jetre (npr. ciroza ili aktivna bolesti jetre) ili povišenje transaminaza iznad 3 x gornje granice normale (vidjeti dijelove 4.2 i 4.4).
English: Do not take Valdoxan - if you are allergic to agomelatine or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Valdoxan - ako ste alergični na agomelatin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6). - ako Vaša jetra ne radi pravilno (ako imate oštećenje jetre).
English: Combination of agomelatine with oestrogens (moderate CYP1A2 inhibitors) results in a several fold increased exposure of agomelatine.
Croatian: Kombinacija agomelatina s estrogenima (umjereni CYP1A2 inhibitori) dovodi do višestruke pojačane izloženosti agomelatinu.
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.
Croatian: Iskustvo s predoziranjem lijekom Valdoxan je ograničeno, no zabilježeni simptomi uključuju bol u gornjem dijelu trbuha, pospanost, umor, uznemirenost, tjeskobu, napetost, vrtoglavicu, cijanozu ili opću slabost.
English: The safety and efficacy of agomelatine in children from 2 years onwards for treatment of major depressive episodes have not yet been established.
Croatian: Sigurnost i djelotvornost agomelatina za liječenje velikih depresivnih epizoda u djece od navršene 2. godine nadalje još nije ustanovljena.
English: - Rare side effects (may affect up to 1 in 1,000 people): serious skin eruption (erythematous rash), face oedema (swelling) and angioedema (swelling of the face, lips, tongue and/or throat that may cause difficulty in breathing or swallowing), hepatitis, yellow coloration of the skin or the whites of the eyes (jaundice), hepatic failure*, hallucinations, inability to remain still (due to physical and mental unrest), inability to completely empty the bladder.
Croatian: Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba): izbijanje ozbiljnih kožnih promjena (eritematozni osip), edem lica (oticanje) i angioedem (oticanje lica, usana, jezika i/ili grla što može imati za posljedicu otežano disanje ili gutanje), hepatitis, žuta boja kože ili bjeloočnica (žutica), zatajenje jetre*, halucinacije, nemogućnost ostajanja u mirnom položaju (zbog fizičke i mentalne uznemirenosti), nemogućnost potpunog pražnjenja mjehura.
English: Rifampicin an inducer of all three cytochromes involved in the metabolism of agomelatine may decrease the bioavailability of agomelatine.
Croatian: Rifampicin je induktor sva tri citokroma uključenih u metabolizam agomelatina te može smanjiti bioraspoloživosti agomelatina.
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.
Croatian: Kod bolesnika koji boluju od depresije, liječenje agomelatinom od 25 mg povećalo je sporovalno spavanje bez mijenjanja količine REM faze sna ili vremena do nastupa REM faze.
English: Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility, embryofoetal development and pre- and post natal development.
Croatian: Studije reprodukcije štakora i kunića pokazuju da agomelatin nema utjecaja na plodnost, embriofetalni razvoj te prenatalni i postnatalni razvoj.
English: Erythematous rash Face oedema and angioedema*
Croatian: Eritematozni osip Edem lica i angioedem*
English: The most common adverse reactions were headache, nausea and dizziness.
Croatian: Najčešće nuspojave bile su glavobolja, mučnina i omaglica.
English: Hepatic impairment Agomelatine is contraindicated in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Croatian: Agomelatin je kontraindiciran kod bolesnika s oštećenjem jetre (vidjeti dijelove 4.3, 4.4. i 5.2.) Pedijatrijska populacija
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).
Croatian: Kod svih bolesnika prije početka liječenja potrebno je napraviti testove funkcije jetre i liječenje se ne smije započeti u bolesnika kod kojih su vrijednosti ALT-a i/ili AST-a >3 puta gornje granice normale na početku liječenja (vidjeti dio 4.3).
English: How to take Valdoxan
Croatian: Kako uzimati Valdoxan
English: These symptoms may also be due to the underlying disease (see section 4.4).
Croatian: Manija/hipomanija* Ovi simptomi mogu također biti posljedica podležeće bolesti (vidjeti dio 4.4)
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.
Croatian: Obavezno obavijestite svog liječnika ako uzimate bilo koje od sljedećih lijekova: propranolol (beta blokator koji se koristi u liječenju hipertenzije), enoksacin (antibiotik).
English: Magnesium stearate Silica, colloidal anhydrous
Croatian: Magnezijev stearat Silicijev dioksid, koloidni, bezvodni
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.
Croatian: godina, N= 222, od kojih je 151 liječen agomelatinom), u trajanju od 8 tjedana, pokazalo je statistički značajnu razliku od 2,67 bodova na HAM-D ukupnoj ljestvici, što je bio primarni ishod.
English: When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.
Croatian: Kada se doza povećava, mora se ponovno provesti testiranje jetrene funkcije istom učestalošću kao i kod uvođenja liječenja.
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:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će osigurati da svi liječnici za koje se očekuje da će propisivati ili koristiti Valdoxan dobiju ažurirani edukacijski materijal koji će sadržavati sljedeće: • Sažetak opisa svojstava lijeka,
English: There is no experience of concurrent use of agomelatine with ECT.
Croatian: Nema iskustva istovremene primjene agomelatina s EKT.
English: Reproduction studies in the rat and the rabbit showed no effect of agomelatine on fertility (see section
Croatian: Ispitivanja reprodukcije štakora i kunića pokazuju da agomelatin nema utjecaja na plodnost (vidjeti dio 5.3 ).
English: Treatment should not be initiated if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4).
Croatian: Liječenje se ne smije započeti ako vrijednost transaminaza premašuje 3 x gornju granicu normale (vidjeti dijelove 4.3 i 4.4).
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).
Croatian: i/ili AST za >3 puta gornje granice normale zabilježen je u 1,2% bolesnika liječenih agomelatinom u dozi od 25 mg dnevno i u 2,6 %
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).
Croatian: Tijekom liječenja vrijednosti transaminaza moraju se pratiti periodično; nakon približno tri tjedna, šest tjedana (kraj akutne faze), dvanaest tjedana, dvadeset četiri tjedna (kraj faze održavanja)
English: Experience with agomelatine in overdose has indicated that epigastralgia, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis or malaise have been reported.
Croatian: Iskustvo s predoziranjem agomelatinom ukazuje da su tom prilikom zabilježeni epigastralgija, somnolencija, umor, agitiranost, anksioznost, napetost, omaglica, cijanoza ili opća slabost.
English: Each film-coated tablet contains 25 mg of agomelatine.
Croatian: Svaka filmom obložena tableta sadrži 25 mg agomelatina.
English: Each film-coated tablet contains 61.8 mg lactose (as monohydrate) For the full list of excipients, see section 6.1.
Croatian: Jedna filmom obložena tableta sadrži 61,8 mg laktoze (u obliku hidrata).
English: Therefore follow-up tests should take place at the following time points:
Croatian: Stoga se moraju provoditi testovi praćenja funkcije jetre u sljedećim vremenskim intervalima:
English: Treatment should be discontinued if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4).
Croatian: Liječenje se mora prekinuti ako vrijednost transaminaza premašuje 3 x gornju granicu normale (vidjeti dijelove 4.3 i 4.4).
English: Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) (see section 4.5).
Croatian: Istovremena primjena potentnih inhibitora CYP1A2 (npr. fluvoksamin, ciprofloksacin) (vidjeti dio
English: If you forget to take Valdoxan
Croatian: Ako prestanete uzimati Valdoxan
English: - If you are suffering from dementia, your doctor will make an individual evaluation of whether it is right for you to take Valdoxan.
Croatian: Ako bolujete od demencije (poremećaj sposobnosti pamćenja), liječnik će napraviti individualnu procjenu je li za Vas sigurno da uzimate Valdoxan.
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.
Croatian: Međutim, dostupan je samo ograničen broj podataka o primjeni agomelatina kod liječenja bolesnika s velikim depresivnim epizodama koji imaju teško ili umjereno oštećenje bubrega, stoga je potrebno pažljivo propisivati agomelatin takvim bolesnicima.
English: If you have any further questions on the use of this product, please ask your doctor or pharmacist.
Croatian: U slučaju dodatnih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
English: Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.
Croatian: Ako ste depresivni, ponekad možete razmišljati o samoozljeđivanju ili samoubojstvu.
English: Valdoxan contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially ‘sodium-free'.
Croatian: Valdoxan sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija
English: • A guidance on the scheme of hepatic monitoring
Croatian: • smjernice o shemi praćenja jetre
English: Based on the evaluation of these tests your doctor will decide whether you should receive or continue using Valdoxan (see also under “How to take Valdoxan” in section 3).
Croatian: Valdoxan ( također pogledajte „Kako uzimati Valdoxan“ u dijelu 3).
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg of agomelatine.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 25 mg agomelatina.
English: Valdoxan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Croatian: Valdoxan sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
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).
Croatian: Prijavljeni su slučajevi oštećenja jetre, uključujući i zatajenje jetre (izuzetno su zabilježeni malobrojni slučajevi sa smrtnim ishodom ili transplantacijom jetre kod bolesnika s rizičnim čimbenicima za nastanak oštećenja jetre), porast jetrenih enzima veći od 10 puta iznad gornje granice normale,
English: You should not take Valdoxan together with certain medicines (see also under “Do not take Valdoxan” in section 2): fluvoxamine (another medicine used in the treatment of depression), ciprofloxacin (an antibiotic) can modify the expected dose of agomelatine in your blood.
Croatian: Valdoxan“): fluvoksamin (drugi lijek koji se koristi u liječenju depresije), ciprofloksacin (antibiotik), jer oni mogu promijeniti očekivanu dozu agomelatina u Vašoj krvi.
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).
Croatian: bolesnika liječenih u kombinaciji s estrogenima, agomelatin je potrebno s oprezom propisivati s ostalim umjerenim inhibitorima CYP1A2 (npr. propranolol, enoksacin) dok se ne stekne više iskustva (vidjeti dio 4.4).
English: Packs of 100 film-coated tablets are also available for hospital use.
Croatian: Za bolničku primjenu dostupno je i pakiranje od 100 filmom obloženih tableta.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Les Laboratoires Servier
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Les Laboratoites Servier
English: 5 How to store Valdoxan Contents of the pack and other information
Croatian: Kako Valdoxan izgleda i sadržaj pakiranja
English: - If you are diabetic, ask your doctor for advice.
Croatian: - Ako bolujete od šećerne bolesti, posavjetujte se sa svojim liječnikom.
English: Akathisia*
Croatian: Akatizija*
English: You have been given Valdoxan to treat your depression.
Croatian: Propisan Vam je radi liječenja depresije.
English: In mice, rats and monkeys sedative effects were observed after single and repeated administration at high doses.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Kod miševa, štakora i majmuna primijećeni su sedativni učinci nakon jedne primjene i nakon ponovljene primjene viših doza.
English: Therefore, clinical consequences of ECT performed concomitantly with agomelatine treatment, are considered to be unlikely.
Croatian: Stoga, nije vjerojatna pojava kliničkih posljedica kod istovremenog EKT liječenja i liječenja agomelatinom.
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.
Croatian: postojao je numerički trend (statistički neznatan) prema manjem broju novonastalih seksualnih disfunkcija s agomelatinom u odnosu na venlafaksin na ljestvici učinaka na seksualnost (engl.
English: Paraesthesia Restless leg syndrome*
Croatian: Sindrom nemirnih nogu*
English: In carcinogenicity studies agomelatine induced an increase in the incidence of liver tumours in the rat and the mouse, at a dose at least 110-fold higher than the therapeutic dose.
Croatian: Kod doza koje su barem 110 puta više od terapijske doze u studijama kancerogenosti agomelatin je doveo do povećanja incidencije jetrenih tumora kod miševa i štakora.
English: Consequently, co-administration of Valdoxan with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
Croatian: Posljedično tome, kontraindicirana je istovremena primjena tableta Valdoxan s potentnim CYP1A2 inhibitorima (npr. fluvoksamin, ciprofloksacin).
English: How to store Valdoxan
Croatian: Kako čuvati Valdoxan
English: (>3 times the upper limit of the normal range) Hepatic failure*(1)
Croatian: Povišena alkalna fosfataza* (>3 puta gornje granice normale) Zatajenje jetre*(1) Žutica*
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).
Croatian: ‐ ako se kod bolesnika pojave simptomi ili znakovi mogućeg oštećenja jetre (kao što su urin tamne boje, svijetlo obojene stolice, žuta boja kože/očiju, bol u gornjem desnom dijelu trbuha,
English: Valdoxan 25 mg film-coated tablets agomelatine
Croatian: Valdoxan 25 mg filmom obložene tablete agomelatin
English: Responder rate analysis favoured agomelatine.
Croatian: Analiza odgovora na terapiju bila je na strani agomelatina.
English: Valdoxan contains lactose
Croatian: Valdoxan sadrži laktozu
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.
Croatian: - Ako primjetite bilo koji od sljedećih znakova i simptoma jetrenih tegoba: neobično tamjenje mokraće, svijetlo obojene stolice, žuta boja kože/očiju, bol u gornjem desnom dijelu trbuha, neobičan umor (osobito povezan s drugim simptomima navedenim gore),
English: Valdoxan contains lactose.
Croatian: Valdoxan sadrži laktozu.
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.
Croatian: Ako Vaš liječnik promijeni Vaš prethodni antidepresiv sa selektivnog inhibitora ponovne pohrane serotonina (SSRI) ili inhibitora ponovne pohrane serotonina i noradrenalina (SNRI) na Valdoxan,
English: - If you are obese or overweight, ask your doctor for advice.
Croatian: Ako ste pretili ili ako imate prekomjernu tjelesnu težinu, posavjetujte se sa svojim liječnikom.
English: What Valdoxan looks like and contents of the pack Valdoxan 25 mg film-coated tablets (tablet) are oblong, orange-yellow with a blue imprint of ‘company logo'
Croatian: Valdoxan 25 mg filmom obložene tablete (tableta) su duguljaste, narančastožute s utisnutim logom tvrtke u plavoj boji na jednoj strani.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 25 mg of agomelatine.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Svaka filmom obložena tableta sadrži 25 mg agomelatina.
English: Level of sodium
Croatian: Sadržaj natrija
English: - If you are taking medicines known to affect the liver.
Croatian: Ako uzimate lijekove za koje se zna da utječe na jetru, posavjetujte se sa svojim liječnikom o tom lijeku.
English: ‐ the increase in serum transaminases exceeds 3 X upper limit of normal.
Croatian: stalan, novonastao i neobjašnjiv umor) ‐ ako je porast serumskih transaminaza veći od 3 x gornje granice normale.