FrancophonIA/ELRC3.0 huggingface dataset:
English: The bioavailability is increased by intake of oral contraceptives and reduced by smoking.
Croatian: Bioraspoloživost se povećava unosom oralnih kontraceptiva a smanjuje se pušenjem.
English: No effect is documented in patients ≥75 years.
Croatian: Učinak nije dokumentiran u bolesnika ≥ 75 godina.
English: Decision of dose increase has to be balanced with a higher risk of transaminases elevation.
Croatian: Odluka o povećanju doze treba biti usklađena s povećanim rizikom od povišenja vrijednosti transaminaza.
English: The peak plasma concentration is reached within 1 to 2 hours.
Croatian: Najviša koncentracija lijeka u plazmi postiže se unutar 1 do 2 sata.
English: Valdoxan starts to act on symptoms of depression in most depressed people within two weeks of starting treatment.
Croatian: Valdoxan počinje djelovati na simptome depresije kod većine depresivnih ljudi unutar dva tjedna od početka liječenja.
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suiciderelated events).
Croatian: Depresija je povezana s povećanim rizikom pojave suicidalnih misli, samoozljeđivanjem i suicidom (događajima vezanim uz suicid).
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Croatian: Ove se misli mogu pojačati prilikom početka uzimanja antidepresiva, jer ovim lijekovima treba vremena da djeluju, obično dva tjedna, no ponekad i duže.
English: You might experience dizziness or sleepiness which could affect your ability to drive or operate machines.
Croatian: Možete osjetiti omaglicu i pospanost što može utjecati na vašu sposobnost upravljanja vozilima i strojevima.
English: Macrogol (6000) Magnesium stearate Titanium dioxide (E171)
Croatian: Makrogol (6000) Magnezijev stearat Titanijev dioksid (E171)
English: Agomelatine passes into the placenta and foetuses of pregnant rats.
Croatian: Agomelatin prelazi u placentu i fetus gravidnih štakora.
English: Before starting treatment
Croatian: Prije početka liječenja
English: What to do to avoid potential serious liver problems - Your doctor should have checked that your liver is working properly before starting the treatment.
Croatian: Što je potrebno učiniti kako biste izbjegli moguće ozbiljne tegobe s jetrom: Vaš liječnik morao je provjeriti da li Vaša jetra normalno radi prije početka liječenja.
English: Most side effects are mild or moderate.
Croatian: Većina nuspojava je blaga ili umjerena.
English: No data are available (see section 4.4).
Croatian: Nema dostupnih podataka (vidjeti dio 4.4.).
English: Suicidal thoughts or behaviour (see section
Croatian: Suicidalne misli ili ponašanje (vidjeti dio 4.4)
English: Packs contain 14, 28, 56, 84 or 98 tablets.
Croatian: Pakiranje sadrži 14, 28, 56, 84 ili 98 tableta.
English: Excretion is mainly (80%) urinary and in the form of metabolites, whereas unchanged compound recovery in urine is negligible.
Croatian: Izlučivanje je uglavnom putem urina (80%) te u obliku metabolita, dok je izlučivanje nepromijenjenog spoja u urinu neznatno.
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.
Croatian: Tijekom nekoliko tjedana možete doživjeti simptome povezane s prestankom liječenja prethodnim lijekom, čak i onda kada se doza Vašeg prethodnog antidepresiva postupno smanjuje.
English: The major metabolites, hydroxylated and demethylated agomelatine, are not active and are rapidly conjugated and eliminated in the urine.
Croatian: Glavni metaboliti, hidroksilirani i demetilirani agomelatin nisu aktivni te se brzo konjugiraju i eliminiraju urinom.
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).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke s obzirom na trudnoću, embrionalni/fetalni razvoj, porođaj ili postnatalni razvoj (vidjeti dio 5.3).
English: Other medicines and Valdoxan
Croatian: Drugi lijekovi i Valdoxan
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.
Croatian: Ako ste uzeli više lijeka Valdoxan nego ste trebali, ili ako je npr. dijete nehotično uzelo lijek, odmah se obratite liječniku.
English: Bipolar disorder/ mania / hypomania
Croatian: Bipolarni poremećaj/ manija/ hipomanija
English: Adverse reactions were usually mild or moderate and occurred within the first two weeks of treatment.
Croatian: Nuspojave su obično bile blage ili umjerene i pojavljivale su se unutar prva dva tjedna liječenja.
English: Potential interactions affecting agomelatine
Croatian: Potencijalne interakcije koji utječu na agomelatin
English: 9 DATE OF THE FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation : 19 February 2009
Croatian: Datum prvog odobrenja: 19.veljače 2009.
English: Response rates were statistically significantly higher with agomelatine compared with placebo.
Croatian: Stope odgovora bile su statistički značajno veće uz agomelatin u usporedbi s placebom.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Valdoxan therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Valdoxan uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Pharmacotherapeutic group: Psychoanaleptics, other antidepressants, ATC-code: N06AX22 Mechanism of action
Croatian: Farmakoterapijska skupina: psihoanaleptici, ostali antidepresivi, ATK oznaka: N06AX22
English: Agomelatine is rapidly and well (≥ 80%) absorbed after oral administration.
Croatian: Agomelatin se brzo i dobro apsorbira (≥ 80%) nakon peroralne primjene.
English: No dose adaptation is required in elderly patients.
Croatian: Nije potrebna prilagodba doze u starijih bolesnika.
English: However, in these studies it was not allowed to increase the start dose of either agomelatine, paroxetine or fluoxetine even if the response was not adequate.
Croatian: Međutim, u ovim ispitivanjima nije bilo dozvoljeno povećati početnu dozu agomelatina, paroksetina ili fluoksetina čak i kada odgovor liječenju nije bio adekvatan.
English: Tolerability of agomelatine in elderly patients was comparable to that seen in the younger adults.
Croatian: Podnošljivost agomelatina u starijih bolesnika je usporediva s onom u mlađih odraslih osoba.
English: The expected benefits of Valdoxan are to reduce and gradually remove the symptoms related to your depression.
Croatian: Očekivana korist lijeka Valdoxan je smanjenje i postepeno nestajanje simptoma vezanih uz depresiju.
English: [EU/1/08/499/002] 14 film-coated tablets [EU/1/08/499/003] 28 film-coated tablets [EU/1/08/499/005] 56 film-coated tablets [EU/1/08/499/006] 84 film-coated tablets [EU/1/08/499/007] 98 film-coated tablets [EU/1/08/499/008] 100 film-coated tablets
Croatian: [EU/1/08/499/002] 14 filmom obloženih tableta [EU/1/08/499/003] 28 filmom obloženih tableta [EU/1/08/499/005] 56 filmom obloženih tableta [EU/1/08/499/006] 84 filmom obloženih tableta [EU/1/08/499/007] 98 filmom obloženih tableta [EU/1/08/499/008] 100 filmom obloženih tableta
English: Agomelatine did not show proconvulsive properties at ip doses up to 128 mg/kg in mice and rats.
Croatian: Agomelatin nije pokazao prokonvulzivna svojstva kod ip doza do 128 mg/kg kod miševa i štakora.
English: The variability is increased with high fat food.
Croatian: Varijabilnost se povećava kod unosa hrane s visokim postotkom masnoće.
English: The pooled analysis of trials using the Arizona Sexual Experience Scale (ASEX) showed that agomelatine was not associated with sexual dysfunction.
Croatian: Objedinjena analiza ispitivanja koja su koristila ljestvicu Arizona Sexual Experience Scale (ASEX) pokazale su da agomelatin nije povezan sa seksualnom disfunkcijom.
English: Warnings and precautions There could be some reasons why Valdoxan may not be suitable for you:
Croatian: Postoje neki razlozi zbog kojih Valdoxan možda nije prikladan za Vas:
English: Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet with blue imprint of company logo on one side.
Croatian: Narančasto-žuta, duguljasta, 9,5 mm dugačka, 5,1 mm široka filmom obložena tableta s plavim utisnutim logotipom tvtke na jednoj strani.
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.
Croatian: U dva ostala ispitivanja, nije bilo moguće donijeti zaključke jer se aktivne kontrole, paroksetin ili fluoksetin nisu razlikovali od placeba.
English: Increased gamma-glutamyltransferase* (GGT)(>3 times the upper limit of the normal range
Croatian: Povišena gama glutamiltransferaza* (GGT) (>3 puta gornje granice normale)
English: There is no data on the influence of race on agomelatine pharmacokinetics.
Croatian: Nema podataka o utjecaju rase na farmakokinetiku agomelatina.
English: In some cases, your doctor may prescribe a higher dose (50 mg), i.e. two tablets to be taken together at bedtime.
Croatian: U nekim slučajevima će Vam liječnik propisati veću dozu (50 mg), tj. dvije tablete koje se uzimaju zajedno prije spavanja.
English: • Information about the risk of hepatic reactions and clinical signs of liver problems
Croatian: • informacije o riziku od jetrenih nuspojava i kliničkih znakova problema s jetrom
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 56 filmom obloženih tableta 84 filmom obloženih tableta 98 filmom obloženih tableta 100 filmom obloženih tableta
English: Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist.
Croatian: Agomelatin je agonist melatonergičkih receptora (MT1 i MT2 receptori) te antagonist 5-HT2c receptora.
English: No dose adjustment is required in relation to age (see section 5.2).
Croatian: Prilagodba doze vezano uz dob nije potrebna (vidjeti dio 5.2).
English: Following discontinuation of Valdoxan therapy liver function tests should be repeated until serum transaminases return to normal.
Croatian: Nakon prekida terapije lijekom Valdoxan, testiranja jetrene funkcije se moraju ponavljati sve dok se serumske transaminaze ne vrate u normalu.
English: Animal studies have not shown proconvulsant properties (see section 5.3).
Croatian: Ispitivanja na životinjama nisu pokazala prokonvulzivna svojstva (vidjeti dio 5.3).
English: Hallucinations*
Croatian: Halucinacije*
English: Agomelatine increases noradrenaline and dopamine release specifically in the frontal cortex and has no influence on the extracellular levels of serotonin.
Croatian: Agomelatin specifično povećava otpuštanje noradrenalina i dopamina u području frontalnog korteksa i ne utječe na izvanstaničnu razinu serotonina.
English: Agomelatine had neutral effect on heart rate and blood pressure in clinical trials.
Croatian: Agomelatin je imao neutralan učinak na brzinu otkucaja srca i krvni tlak u kliničkim ispitivanjima.
English: Valdoxan with alcohol
Croatian: Valdoxan s alkoholom
English: There is no relevant use of agomelatine in children from birth to 2 years for treatment of major depressive episodes.
Croatian: Nema relevantne primjene agomelatina u djece u dobi od rođenja do 2. godine za liječenje velikih depresivnih epizoda.
English: Your depression should be treated for a sufficient period of at least 6 months to ensure that you are free of symptoms.
Croatian: Vaša depresija treba biti liječena dovoljno dugo, najkraće 6 mjeseci, kako bi se zajamčilo da ste bez simptoma.
English: You should discuss with your doctor on the best way of stopping your previous antidepressant medicine when starting Valdoxan.
Croatian: Posavjetujte se sa svojim liječnikom o tome koji je najbolji način za prekid Vašeg prethodnog antidepresiva pri započinjanju liječenja Valdoxanom.
English: Breastfeeding should be discontinued if you take Valdoxan.
Croatian: Dojenje treba prekinuti ako uzimate Valdoxan.
English: Elimination is rapid, the mean plasma half-life is between 1 and 2 hours and the clearance is high (about 1,100 ml/min) and essentially metabolic.
Croatian: Eliminacija je brza, srednja vrijednost poluvijeka u plazmi je između 1 i 2 sata, a klirens je visok (oko 1 100 ml/min) i uglavnom metabolički.
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Valdoxan should therefore not be used in these patients.
Croatian: Prema tome, Valdoxan se ne smije primjenjivati kod tih bolesnika.
English: No effect of agomelatine on juvenile animals behavioural performances, visual and reproductive function were observed.
Croatian: Nije zabilježen učinak agomelatina na ponašanje mladih životinja, kao ni na vizualne i reproduktivne funkcije.
English: Kinetics are not modified after repeated administration.
Croatian: Kinetika ostaje neizmijenjena nakon ponovljene primjene.
English: Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Croatian: Bolesnike (i njihove njegovatelje) treba upozoriti da je potrebno paziti na eventualnu pojavu bilo kakvog kliničkog pogoršanja, pojavu suicidalnog ponašanja ili misli i neuobičajenih promjena ponašanja te ako su prisutni takvi simptomi da je potrebno odmah zatražiti medicinski savjet.
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
Croatian: Nuspojave su niže navedene prema sljedećoj učestalosti: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100) ; rijetko (≥1/10 000 i <1/1000) ; vrlo rijetko (<1/10 000) ; nepoznato (ne može se procijeniti iz dostupnih podataka).
English: What Valdoxan is and what it is used for What you need to know before you take Valdoxan How to take Valdoxan
Croatian: Što je Valdoxan i za što se koristi Što morate znati prije nego počnete uzimati Valdoxan Kako uzimati Valdoxan
English: * Few cases resulting in liver transplantation or death have been reported.
Croatian: *Prijavljeno je nekoliko slučajeva koji su završili transplantacijom jetre ili sa smrtnim ishodom.
English: Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/19 (10%).
Croatian: Agomelatin uglavnom metabolizira citokrom P450 1A2 (CYP1A2) (90%) te CYP2C9/19 (10%).
English: In humans, agomelatine has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.
Croatian: Kod ljudi, agomelatin ima svojstva pozitivnog mijenjanja faza; izaziva uznapredovalu fazu sna, pad tjelesne temperature i nastup djelovanja melatonina.
English: In the therapeutic dose-range, agomelatine systemic exposure increases proportionally with dose.
Croatian: Unutar raspona terapijskih doza, sistemska izloženost agomelatinu proporcionalno raste s dozom.
English: No specific antidotes for agomelatine are known.
Croatian: Nije poznat nikakav specifičan antidot agomelatina.
English: Agomelatine inhibits neither CYP1A2 in vivo nor the other CYP450 in vitro.
Croatian: Agomelatin ne inhibira ni CYP1A2 in vivo, niti ostale CYP450 in vitro.
English: Primary endpoint was change in HAMD-17 score from baseline.
Croatian: Primarni ishod je bila promjena u vrijednosti HAMD-17 skora od početne.
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.
Croatian: Učestalost benignih fibroadenoma mliječnih žlijezda koji su zamijećeni kod štakora povećana je kod veće izloženosti (60-erostruka izloženost pri terapijskim dozama), ali ostaje u jednakom rasponu kao od kontrole.
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.
Croatian: Kod glodavaca, zamijećena je znatna indukcija CYP2B i umjerena indukcija CYP1A i CYP3A pri 125 mg/kg/dan dok je kod majmuna indukcija bila blaža za CYP2B i CYP3A pri 375 mg/kg/dnevno.
English: During your treatment with Valdoxan :
Croatian: Tijekom Vašeg liječenja lijekom Valdoxan:
English: Medical follow-up in a specialised environment is recommended.
Croatian: Preporučena je kontrola liječnika specijalista.
English: How to switch from an antidepressant medicine (SSRI/SNRI) to Valdoxan?
Croatian: Kako promijeniti liječenje s antidepresiva (SSRI/SNRI) na Valdoxan?
English: Valdoxan film-coated tablets may be taken with or without food.
Croatian: Valdoxan filmom obložene tablete mogu se uzimati sa ili bez obroka.
English: Liver function tests should be performed in all patients before starting treatment.
Croatian: Potrebno je provesti testiranje jetrene funkcije kod svih bolesnika prije početka liječenja.
English: - If you have bipolar disorder, have experienced or if you develop manic symptoms (a period of abnormally high excitability and emotions) talk to your doctor before you start taking this medicine or before you continue with this medicine (see also under “Possible side effects” in section 4).
Croatian: Ako bolujete od bipolarnog poremećaja, ako ste već imali ili imate simptome manije (razdoblje izrazito velike razdražljivosti i emocija) obratite se svom liječniku prije nego počnete uzimati ovaj lijek ili prije nastavljanja uzimanja ovog lijeka (pogledajte „Moguće nuspojave“ u dijelu
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.
Croatian: Agomelatin je pokazao učinak sličan antidepresivima na životinjskim modelima za depresiju (test naučene bespomoćnosti, test očajavanja, kronični blagi stres) kao i na modelima s desinkronizacijom cirkadijalnog ritma te na modelima vezanim uz stres i anksioznost.
English: Any dose increase to 50 mg should be made on an individual patient benefit/risk basis and with strict respect of Liver Function Test monitoring.
Croatian: Svako povećanje doze na 50 mg treba se temeljiti na individualnoj procjeni odnosa koristi/rizika za svakog bolesnika, uz pomno praćenje jetrene funkcije.
English: Preferred Term
Croatian: Preporučeni izraz
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.
Croatian: Provedeno je deset placebom kontroliranih kliničkih ispitivanja kako bi se ispitala kratkoročna djelotvornost agomelatina kod velikog depresivnog poremećaja u odraslih, s fiksnom dozom i/ili sa titracijom doza.
English: Confusional state*
Croatian: Konfuzno stanje*
English: Available pharmacodynamic/toxicological data in animals have shown excretion of agomelatine/metabolites in milk (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazuju da se agomelatin/metaboliti izlučuju u mlijeko (vidjeti dio 5.3).
English: Any patient who develops increased serum transaminases should have his/her liver function tests repeated within 48 hours.
Croatian: Kod svakog bolesnika kod kojeg se povećaju serumske transaminaze mora se ponovno testirati jetrena funkcija unutar 48 sati.
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).
Croatian: Pušenje inducira CYP1A2 i dokazano je da smanjuje bioraspoloživost agomelatina, osobito u teških pušača (≥ 15 cigareta/dan) (vidjeti dio 5.2).
English: The efficacy and safety of agomelatine (25 to 50mg/day) have been established in elderly depressed patients (< 75years).
Croatian: Djelotvornost i sigurnost primjene agomelatina (25 do 50 mg/dan) dokazana je kod starijih bolesnika koji boluju od depresije (< 75 godina).
English: If your doctor increase the dose to 50mg, laboratory tests should be performed at this initiation and then periodically during treatment, usually after 3 weeks, 6 weeks, 12 weeks and 24 weeks.
Croatian: Ako Vam liječnik poveća dozu na 50 mg, laboratorijske pretrage moraju se raditi na početku povećanja doze, a zatim i redovito tijekom liječenja, obično nakon 3 tjedna, 6 tjedana, 12 tjedana i 24 tjedna.
English: If you stop taking Valdoxan Do not stop taking your medicine without the advice of your doctor even if you feel better.
Croatian: Nemojte prestati uzimati ovaj lijek bez savjetovanja s Vašim liječnikom, čak i ako se osjećate bolje.
English: Valdoxan is used in adults.
Croatian: Valdoxan se primjenjuje u odraslih.
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.
Croatian: Nisu pronađeni dokazi o farmakokinetičkoj ili farmakodinamičkoj interakciji s lijekovima koji se mogu propisati za istovremenu primjenu s lijekom Valdoxan u ciljanoj populaciji tijekom faze I kliničkih studija: benzodiazepini, litij, paroksetin, flukonazol i teofilin.
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.
Croatian: Ako se Valdoxan počinje primjenjivati tijekom postupnog smanjenja doze prethodnog lijeka, moguće simptome povezane s prestankom liječenja se ne smije zamijeniti s nedostatkom ranog učinka Valdoxana.
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.
Croatian: Simptomi depresije variraju od osobe do osobe, ali često uključuju duboku tugu, osjećaj bezvrijednosti, gubitak interesa za omiljene aktivnosti, poremećaje sna, osjećaj usporenosti, osjećaj tjeskobe, promjene tjelesne težine.
English: Potential for agomelatine to affect other medicinal products
Croatian: Potencijal utjecaja agomelatina na druge lijekove
English: Effect of Valdoxan is not documented in patients aged 75 years and older.
Croatian: Učinak lijeka Valdoxan nije ispitan kod bolesnika od 75 godina i starijih.
English: In a pharmacokinetic study in elderly patients (≥ 65 years), it was showed that at a dose of 25 mg the mean AUC and mean Cmax were about 4-fold and 13-fold higher for patients ≥ 75 years old compared to patients < 75 years old.
Croatian: U farmakokonetičkoj studiji u starijih bolesnika (≥ 65 godina), pokazalo se da su pri dozi od 25 mg srednja vrijednost AUC-a i Cmax bili 4 puta odnosno 13 puta veći kod bolesnika ≥75 godina u usporedbi s bolesnicima < 75 godina.
English: Hyperhidrosis Eczema Pruritus* Urticaria*
Croatian: Hiperhidroza Ekcem Svrbež* Urtikarija*