FrancophonIA/ELRC3.0 huggingface dataset:
English: Steady state volume of distribution is about 35 l and plasma protein binding is 95% irrespective of the concentration and is not modified with age and in patients with renal impairment but the free fraction is doubled in patients with hepatic impairment.
Croatian: Distribucija Volumen distribucije u stanju dinamičke ravnoteže iznosi oko 35 l, a vezanje na proteine plazme iznosi 95% neovisno o koncentraciji i ne mijenja se s dobi bolesnika te kod bolesnika s oštećenjem bubrega, ali se slobodna frakcija udvostručuje kod bolesnika s oštećenjem jetre.
English: Agomelatine was not compared directly with paroxetine and fluoxetine as these comparators where added in order to ensure assay sensitivity of the trials.
Croatian: Agomelatin nije uspoređivan neposredno sa paroksetinom i fluoksetinom budući da su ovi komparatori dodani da bi se postigla analitička osjetljivost ispitivanja.
English: Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Croatian: Bolesnici s anamnezom događaja povezanih sa suicidom ili oni kod kojih su suicidalne ideje znatno izražene prije početka liječenja imaju veći rizik pojave suicidalnih misli ili pokušaja suicida te se moraju pomnije promatrati tijekom liječenja.
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.
Croatian: Postotak bolesnika s barem jednim simptomom povezanim s prestankom primjene tjedan dana nakon prestanka liječenja s SSRI/ SNRI manji je u skupini bolesnika s dugotrajnijim postupnim smanjivanjem doze (postepeni prestanak liječenja s prethodnim SSRI ili SNRI unutar 2 tjedna) nego u skupini bolesnika s kratkotrajnijim postupnim smanjivanjem doze (postepeni prestanak liječenja s prethodnim SSRI ili SNRI unutar 1 tjedna) i skupini s naglim zamjenskim liječenjem (nagli prestanak): 56,1%, 62,6%, odnosno 79,8%.
English: At higher doses, a saturation of the first-pass effect occurs.
Croatian: Pri višim dozama javlja se zasićenje zbog učinka prvog prolaza.
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.
Croatian: Liječnik će Vas poslati da obavite laboratorijske pretrage kako bi provjerio da li Vaša jetra normalno radi prije početka liječenja, a zatim i redovito tijekom liječenja, obično nakon 3 tjedna, 6 tjedana, 12
English: The maintenance of antidepressant efficacy was demonstrated in a relapse prevention trial.
Croatian: Održanost djelotvornosti antidepresiva pokazana je u ispitivanju sprečavanja relapsa bolesti.
English: The efficacy and safety of agomelatine in major depressive episodes have been studied in a clinical programme including 7,900 patients treated with agomelatine.
Croatian: Proučavani su djelotvornost i sigurnost agomelatina kod velikih depresivnih epizoda u kliničkim ispitivanjima koja su obuhvaćala 7 900 bolesnika liječenih agomelatinom.
English: The incidence of relapse during the 6-months double-blind follow up period was 22% and 47% for agomelatine and placebo, respectively.
Croatian: Incidencija recidiva tijekom 6-mjesečnog dvostruko slijepog praćenja bila je 22% za agomelatin, a 47% za placebo.
English: Liver tumours are most likely related to enzyme induction specific to rodents.
Croatian: Tumori jetre vjerojatno su povezani s indukcijom enzima koji su karakteristični za glodavce.
English: At the end of treatment (over 6 or 8 weeks), significant efficacy of agomelatine 25-50 mg was demonstrated in 6 out of the ten short-term double-blind placebo-controlled trials.
Croatian: Na kraju liječenja (tijekom 6 ili 8 tjedana), dokazana je značajna djelotvornost agomelatina od 25-50 mg u 6 od deset kratkotrajnih dvostruko slijepih placebom kontroliranih ispitivanja.
English: Agomelatine 25-50 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.0001) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Croatian: Doza agomelatina od 25-50 mg jednom dnevno pokazala je statistički značajnu superiornost u odnosu na placebo (p=0,0001) u prvoj mjeri ishoda, u sprječavanju recidiva depresije, mjereno prema vremenu do relapsa bolesti.
English: The pattern of liver damage is predominantly hepatocellular with increased serum transaminases, which usually return to normal levels on cessation of agomelatine.
Croatian: Prevladava hepatocelularni oblik oštećenja jetre s povišenim serumskim transaminazama koje se obično vraćaju na normalnu razinu prestankom primjene agomelatina.
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).
Croatian: Valdoxan se mora pažljivo koristiti u bolesnika koji su bolovali od bipolarnog poremećaja, manije ili hipomanije, a liječenje treba prekinuti ako se u bolesnika pojave simptomi manije (vidjeti dio 4.8).
English: There is limited experience with agomelatine overdose.
Croatian: Postoje ograničena iskustva povezana s predoziranjem agomelatinom.
English: What you need to know before you take Valdoxan
Croatian: Što morate znati prije nego počnete uzimati Valdoxan
English: Calendar packs containing 14, 28, 56, 84 and 98 film-coated tablets.
Croatian: Kalendarsko pakiranje sadrži 14, 28, 56, 84 i 98 filmom obloženih tableta.
English: No relevant modification in agomelatine pharmacokinetic parameters in patients with severe renal impairment has been observed.
Croatian: Nisu zamijećene nikakve značajne promjene u farmakokinetičkim parametrima agomelatina kod bolesnika s teškim oštećenjem bubrega.
English: Agomelatine 25 mg also induced an advance of the time of sleep onset and of minimum heart rate.
Croatian: Agomelatin od 25 mg također je uzrokovao skraćenje vremena nastupa sna i minimalnih otkucaja srca.
English: No relevant modification of pharmacokinetic parameters in patients with severe renal impairment has been observed (n=8, single dose of 25 mg), but caution should be exercised in patients with severe or moderate renal impairment as only limited clinical data are available in these patients (see section 4.2).
Croatian: Nisu zamijećene bitne promjene farmakokinetičkih parametara kod bolesnika s teškim oštećenjem bubrega (n=8, pojedinačna doza od 25 mg), ali je oprez potreban kod bolesnika s teškim ili umjerenim oštećenjem bubrega s obzirom na to da su za te bolesnike dostupni samo ograničeni klinički podaci (vidjeti dio 4.2).
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).
Croatian: • laktoza hidrat, kukuruzni škrob, povidon (K30), natrijev škroboglikolat, vrste A, stearatna kiselina, magnezijev stereat, koloidni bezvodni silicijev dioksid, hipromeloza, glicerol, makrogol (6000), željezov oksid, žuti (E172) i titanijev dioksid (E171).
English: Hypromellose Yellow iron oxide (E172) Glycerol
Croatian: Željezov oksid, žuti (E172) Glicerol
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.
Croatian: Valdoxan se ne preporučuje za liječenje depresije kod bolesnika mlađih od 18 godina s obzirom na to da sigurnost i djelotvornost lijeka Valdoxan nisu utvrđeni za tu dobnu skupinu.
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).
Croatian: Provedeno je posebno kontrolirano ispitivanje u trajanju od 3 tjedna na bolesnicima koji boluju od velikog depresivnog poremećaja, a bolest im se nije dostatno poboljšala primjenom paroksetina (SSRI) ili venlafaksina (SNRI).
English: No hepatotoxicity was observed in rodents and monkeys in the repeat dose toxicity studies.
Croatian: Kod glodavaca i majmuna nije zamijećena hepatotoksičnost u studijama toksičnosti ponovljenih doza.
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.
Croatian: Valdoxan se ne smije koristiti za liječenje velikih depresivnih epizoda u starijih bolesnika s demencijom s obzirom na to da u tih bolesnika sigurnost i djelotvornost lijeka Valdoxan nije utvrđena.
English: Agomelatine resynchronises circadian rhythms in animal models of circadian rhythm disruption.
Croatian: Agomelatin ponovo usklađuje cirkadijski ritam u životinjskim modelima poremećaja cirkadijskog ritma.
English: In clinical trials among children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed compared to those treated with placebo (see section 4.2).
Croatian: U kliničkim studijama provedenim na djeci i adolescentima koji su liječeni drugim antidepresivima, suicidalno ponašanje (pokušaji suicida i suicidalne misli), agresivnost (uglavnom agresija, suparničko ponašanje i gnjev) češće su primijećeni u usporedbi s bolesnicima liječenim placebom (vidjeti dio 4.2).
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.
Croatian: Sigurnosne farmakološke studije pokazale su da agomelatin nema utjecaja na hERG (humani Ether àgo-go Related Gene) potencijal ili na akcijski potencijal Purkinjeovih stanica u pasa.
English: The calendar printed on the blister containing the tablets should help you remembering when you last took a tablet of Valdoxan.
Croatian: Kalendar ispisan na blisteru koji sadrži tablete pomoći će Vam sjetiti se kada ste zadnji put uzeli
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Valdoxan, are provided with patient booklets to be distributed to their patients being prescribed this medicine.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet mora osigurati da svi liječnici, za koje se očekuje da propisuju ili upotrebljavaju Valdoxan, dobiju knjižice za bolesnike koje će podijeliti bolesnicima kojima propisuju ovaj lijek.
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).
Croatian: Nije zabilježen učinak agomelatina u bolesnika ≥ 75 godina, zbog toga se agomelatin ne bi trebao primjenjivati u bolesnika ove dobne skupine (vidjeti dijelove 4.2 i 5.1).
English: The frequencies have not been corrected for placebo.
Croatian: Za navedene nuspojave nije rađena korekcija učestalosti prema placebu.
English: Calendar packs of 100 film-coated tablets for hospital use.
Croatian: Kalendarsko pakiranje od 100 filmom obloženih tableta za bolničku primjenu.
English: Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (aged less than 25 years) with psychiatric conditions who were being treated with an antidepressant.
Croatian: Podaci iz kliničkih ispitivanja pokazali su da postoji povećan rizik od suicidalnog ponašanja kod mladih odraslih osoba (mlađih od 25 godina) koji boluju od psihičkih poremećaja, a liječe se antidepresivima.
English: This risk persists until significant remission occurs.
Croatian: Ovaj rizik traje do remisije bolesti.
English: - If you have increased levels of liver enzymes before treatment, your doctor will decide if Valdoxan is right for you.
Croatian: Ako imate povišenu razinu jetrenih enzima prije liječenja, Vaš liječnik će odrediti da li je Valdoxan prikladan lijek za Vas.
English: If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Croatian: Ako bilo kada razmišljate o samoozljeđivanju ili samoubojstvu, obratite se svom liječniku ili odmah odite u bolnicu.
English: Use in paediatric population
Croatian: Primjena u pedijatrijskoj populaciji
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Croatian: Kliničko poboljšanje će se možda postići tek nakon nekoliko tjedana liječenja, stoga se bolesnici trebaju pažljivo motriti dok ne dođe do poboljšanja.
English: - if you are taking fluvoxamine (another medicine used in the treatment of depression) or ciprofloxacin (an antibiotic).
Croatian: - ako uzimate fluvoksamin (drugi lijek koji se koristi u liječenju depresije) ili ciprofloksacin
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).
Croatian: Potreban je oprez kada se Valdoxan primijenjuje kod bolesnika kod kojih su transaminaze povišene bile prije liječenja (> gornje granice od normalnog raspona i ≤3 puta gornje granice od normalnog raspona).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with agomelatine in one or more subsets of the paediatric population in the treatment of major depressive episodes (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja agomelatina u jednoj ili više podskupina pedijatrijske populacije u liječenju velikih depresivnih epizoda (vidjeti dio
English: Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine.
Croatian: Lijekovi koji su u interakciji s ovim izoenzimima mogu povećati ili smanjiti bioraspoloživost agomelatina.
English: As a precautionary measure, it is preferable to avoid the use of Valdoxan during pregnancy.
Croatian: poželjno je izbjegavati primjenu lijeka Valdoxan tijekom trudnoće.
English: It is not known whether agomelatine/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se agomelatin/metaboliti u majčino mlijeko.
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.
Croatian: Fluvoksamin, potentni CYP1A2 i umjereni CYP2C9 inhibitor, značajno inhibira metabolizam agomelatina što dovodi do 60-erostrukog povećanja (raspon 12-412) izloženosti agomelatinu.
English: Weight increased *
Croatian: Povećanje tjelesne težine*
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.
Croatian: Zabilježen je blagi gubitak tjelesne težine neovisno o dozi lijeka, a koji je vezan uz farmakološka svojstva kao i manji učinci na muški reproduktivni sustav bez oštećenja reproduktivne sposobnosti.
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.
Croatian: Ukoliko nakon dva tjedna liječenja izostane ublažavanje simptoma, doza se može povećati na 50 mg jednom dnevno, tj. dvije tablete od 25 mg koje se uzimaju prije spavanja.
English: What Valdoxan contains - The active substance is agomelatine.
Croatian: Što Valdoxan sadrži - Djelatna tvar je agomelatin.
English: Food intake (standard meal or high fat meal) does not modify the bioavailability or the absorption rate.
Croatian: Unos hrane (standardni obrok ili obrok s većom količinom masti) ne mijenja bioraspoloživost ili brzinu apsorpcije agomelatina.
English: A battery of in vitro and in vivo standard genotoxicity assays concludes to no mutagenic or clastogenic potential of agomelatine.
Croatian: Skup in vitro i in vivo standardnih analiza genotoksičnosti zaključuju da ne postoji ni mutageni ni klastogeni potencijal agomelatina.
English: Agomelatine can be started immediately while tapering the dosage of a SSRI//SNRI (see section
Croatian: Primjena agomelatina može započeti odmah, tijekom postupnog smanjenja doze SSRI/SNRI (vidjeti dio 5.1).
English: No improvement was observed in very elderly patients (≥75 years, N= 69, of which 48 on agomelatine).
Croatian: (≥ 75 godina, N = 69, od kojih je 48 liječenih agomelatinom).
English: The below table gives the adverse reactions observed from placebo-controlled and active-controlled clinical trials.
Croatian: Niže navedena tablica navodi nuspojave koje su zabilježene u placebom kontroliranim kliničkim ispitivanjima i kliničkim ispitivanjima s aktivnom kontrolom.
English: - after around 3 weeks, - after around 6 weeks (end of acute phase), - after around 12 and 24 weeks (end of maintenance phase), - and thereafter when clinically indicated.
Croatian: - nakon približno 3 tjedna, - nakon približno 6 tjedana (kraj akutne faze), - nakon približno 12 i 24 tjedna (kraj faze održavanja),
English: From the first week of treatment, onset of sleep and the quality of sleep were significantly improved without daytime clumsiness as assessed by patients.
Croatian: Prema procjeni bolesnika od prvog tjedna liječenja, nastupanje faze sna i kvaliteta sna značajno su poboljšani bez pojave nespretnosti tijekom dana.
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.
Croatian: Meta-analiza placebom kontroliranih kliničkih ispitivanja primjene antidepresiva u odraslih bolesnika s psihijatrijskim poremećajima otkrila je povećanje rizika pojave suicidalnog ponašanja kod bolesnika mlađih od 25 godina koji su liječeni antidepresivima u usporedbi s onima koji su primali placebo.
English: Treatment with Valdoxan should only be prescribed after careful consideration of benefit and risk in patients with hepatic injury risk factors e.g.:
Croatian: Liječenje Valdoxanom smije se propisati nakon pažljivog razmatranja omjera koristi i rizika u bolesnika s rizičnim čimbenicima za nastanak oštećenja jetre npr.:
English: In vivo, agomelatine does not induce CYP450 isoenzymes.
Croatian: In vivo, agomelatin ne inducira CYP450 izoenzime.
English: Tinnitus*
Croatian: Tinitus*
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of agomelatine in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni agomelatina u trudnica ograničeni (manje od 300 ishoda trudnoća).
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.
Croatian: Potreban je oprez prije početka liječenja te se mora pomno pratiti sve bolesnike tijekom trajanje liječenja, osobito ako su prisutni čimbenici rizika za nastanak oštećenja jetre ili ako se istodobno primjenjuju lijekovi povezani s rizikom od nastanka oštećenja jetre.
English: Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co. Wicklow, Ireland Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
Croatian: Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, Francuska Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co.
English: The recommended dose is 25 mg once daily taken orally at bedtime.
Croatian: Doziranje Preporučena doza je 25 mg jednom dnevno, primijenjena peroralno prije spavanja.
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).
Croatian: U posebnoj studiji koja je obuhvaćala bolesnike sa cirozom jetre, s kroničnim blagim (Child-Pugh A stadij bolesti) ili umjerenim (Child-Pugh B stadij) oštećenjem jetre, izloženost agomelatinu od 25 mg bila je značajno povećana (70 odnosno 140 puta), u usporedbi s odgovarajućim dobrovoljcima (s obzirom na dob, tjelesnu težinu i pušenje) koji nisu imali zatajenje jetre (vidjeti dijelove 4.2, 4.3 i
English: Therefore, agomelatine will not modify exposure to medicinal products metabolised by CYP 450.
Croatian: Stoga, agomelatin neće modificirati izloženost lijeku koji metabolizira CYP
English: Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.
Croatian: Bolesnici koji pate od depresije trebali bi se liječiti dovoljno dugo, barem tijekom perioda od 6 mjeseci kako bi se u potpunosti uklonili simptomi.
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.
Croatian: U ispitivanju namijenjenom procijeniti simptome ustezanja, provedenom prema (Discontinuation Emergent Signs and Symptoms, DESS) kontrolnoj listi simptoma i znakova ustezanja na bolesnicima s depresijom u remisiji, agomelatin nije izazvao sindrom ustezanja nakon naglog prekida liječenja.
English: Do not take a double dose to make up for a forgotten dose.
Croatian: Ako ste zaboravili uzeti Valdoxan Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Switching therapy from SSRI/SNRI antidepressant to agomelatine Patients may experience discontinuation symptoms after cessation from an SSRI/ SNRI antidepressant.
Croatian: Zamjena terapije sa SSRI/SNRI antidepresiva na agomelatin Bolesnici mogu imati simptome povezane s prestankom primjene SSRI/SNRI antidepresiva.
English: The Marketing Authorisation Holder shall agree the format and content of the patient booklet with the National Competent Authority in the Member State.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će usuglasiti format i sadržaj knjižice za bolesnika s nadležnim nacionalnim tijelom u zemlji članici.
English: The combination of agomelatine and alcohol is not advisable.
Croatian: Ne preporučuje se kombinirati agomelatin s alkoholom.
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.
Croatian: Kada je liječenje tim antidepresivima zamijenjeno liječenjem s agomelatinom, pojavili su se simptomi povezani s prestankom primjene SSRI ili SNRI, bilo nakon naglog prekida, bilo nakon postepenog prekida prethodne terapije.
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.
Croatian: Agomelatin ne predstavlja potencijalnu opasnost za zlouporabu prema mjerenjima na zdravim dobrovoljcima na specifičnoj vizualnoj analognoj skali ili na kontrolnoj listi Addiction Research
English: Nightmares*
Croatian: Noćne more*
English: Agomelatine failed to differentiate from placebo in two trials where the active control, paroxetine or fluoxetine showed assay sensitivity.
Croatian: Agomelatin se nije razlikovao od placeba u dva ispitivanja gdje su aktivne kontrole, paroksetin ili fluoksetin,