FrancophonIA/ELRC3.0 huggingface dataset:
English: Just carry on with the next dose at the usual time.
Slovenian: Preprosto nadaljujte z naslednjim odmerkom ob običajnem času.
English: Most of them occurred during the first months of treatment.
Slovenian: Večina se jih je pojavila v prvih mesecih zdravljenja.
English: The total number of patients receiving 50 mg was too low to draw any conclusions.
Slovenian: Celotno število bolnikov, ki so prejemali odmerek 50 mg, je bilo premajhno za kakršenkoli zaključek.
English: It belongs to a group of medicines called antidepressants.
Slovenian: Sodi v skupino zdravil, imenovanih antidepresivi.
English: Medical follow-up in a specialised environment is recommended.
Slovenian: Priporočljivo je zdravniško spremljanje v specializiranem centru.
English: Suicide/suicidal thoughts
Slovenian: Samomor / samomorilne misli
English: Arklow - Co. Wicklow - Ireland
Slovenian: Arklow - Co. Wicklow Irska
English: Depression is a continuing disturbance of mood that interferes with everyday life.
Slovenian: Depresija je daljša motnja razpoloženja, ki moti vsakdanje življenje.
English: Make sure that your reactions are normal before driving or operating machines.
Slovenian: Prepričajte se, da so vaši odzivi normalni, preden upravljate vozila in stroje.
English: The frequencies have not been corrected for placebo.
Slovenian: Pogostnosti niso bile popravljene glede na placebo.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali boste morda začeli jemati katero koli drugo zdravilo.
English: - if your liver does not work properly (hepatic impairment).
Slovenian: - če vaša jetra ne delujejo pravilno (jetrna okvara),
English: Mania/hypomania*
Slovenian: manija/hipomanija*
English: - If you are taking medicines known to affect the liver.
Slovenian: - Če jemljete zdravila, ki vplivajo na jetra.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Slovenian: Splošne klinične izkušnje kažejo, da se tveganje za samomor v zgodnji fazi izboljšanja lahko zveča.
English: Annopol 6B - 03-236 Warszawa, Poland Laboratorios Servier, S.L, Avda.
Slovenian: Annopol 6B - 03-236 Warszawa, Poljska Laboratorios Servier, S.L., Avda.
English: Valdoxan should not be used in children and adolescents (under 18 years old).
Slovenian: Zdravilo Valdoxan se ne sme uporabljati pri otrocih in mladostnikih (mlajših od 18 let).
English: Management of overdose should consist of treatment of clinical symptoms and routine monitoring.
Slovenian: Obravnavanje prevelikega odmerjanja naj vključuje zmanjševanje kliničnih simptomov in rutinsko spremljanje.
English: One person having ingested 2,450 mg agomelatine, recovered spontaneously without cardiovascular and biological abnormalities.
Slovenian: Oseba, ki je zaužila 2.450 mg agomelatina, je okrevala spontano brez kardiovaskularnih in bioloških nenormalnosti.
English: Valdoxan should therefore not be used in these patients.
Slovenian: Zdravila Valdoxan se zato pri teh bolnikih ne sme uporabljati.
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.
Slovenian: Kako se izogniti potencialnim resnim težavam z jetri: - Zdravnik mora preveriti pravilno delovanje vaših jeter pred uvedbo zdravljenja.
English: Before starting treatment
Slovenian: Pred uvedbo zdravljenja
English: The bioavailability is increased in women compared to men.
Slovenian: Biološka uporabnost je večja pri ženskah kot pri moških.
English: You should swallow your tablet with a drink of water.
Slovenian: Tableto pogoltnite s požirkom vode.
English: The maintenance of antidepressant efficacy was demonstrated in a relapse prevention trial.
Slovenian: Ohranjanje antidepresivne učinkovitosti so dokazali v preskušanju o preprečevanju relapsov.
English: You must not use Valdoxan if your liver does not work properly.
Slovenian: Zdravila Valdoxan ne smete jemati, če vaša jetra ne delujejo pravilno.
English: Date of latest renewal : 12 December 2018
Slovenian: Datum prve odobritve: 19. februar 2009 Datum zadnjega podaljšanja: 12. december 2018
English: Absolute bioavailability is low (< 5% at the therapeutic oral dose) and the interindividual variability is substantial.
Slovenian: Absolutna biološka uporabnost je majhna (< 5 % ob terapevtskem peroralnem odmerku) in nihanje med posamezniki je veliko.
English: Agomelatine does not alter daytime vigilance and memory in healthy volunteers.
Slovenian: Agomelatin ne moti dnevne budnosti in spomina pri zdravih prostovoljcih.
English: If you stop taking Valdoxan Do not stop taking your medicine without the advice of your doctor even if you feel better.
Slovenian: Če ste prenehali jemati zdravilo Valdoxan Ne prenehajte jemati zdravila brez zdravniškega nasveta niti če se počutite bolje.
English: These symptoms may also be due to the underlying disease (see section 4.4).
Slovenian: Ta simptoma sta lahko prisotna tudi kot posledica osnovne bolezni (glejte poglavje 4.4).
English: Therefore follow-up tests should take place at the following time points:
Slovenian: Laboratorijske preiskave je zato treba opraviti v naslednjih časovnih intervalih:
English: They usually occur within the first two weeks of the treatment and are usually temporary.
Slovenian: Običajno se pojavijo v prvih dveh tednih zdravljenja in so prehodni.
English: These adverse reactions were usually transient and did not generally lead to cessation of therapy.
Slovenian: Neželeni učinki so običajno bili prehodni in na splošno niso povzročali prekinitev zdravljenja.
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.
Slovenian: Vsako povečanje odmerka na 50 mg mora temeljiti na individualni osnovi koristi/tveganja in ob strogem upoštevanju pregledovanja delovanja jeter.
English: before initiation or dose increase around 3 weeks around 6 weeks around 12 weeks around 24 weeks
Slovenian: pred uvedbo ali povečanjem odmerka po približno 3 tednih po približno 6 tednih po približno 12 tednih po približno 24 tednih
English: System organ class
Slovenian: Razred organskega sistema
English: Kinetics are not modified after repeated administration.
Slovenian: Kinetika se ob ponavljajočem odmerjanju ne spreminja.
English: The expected benefits of Valdoxan are to reduce and gradually remove the symptoms related to your depression.
Slovenian: Pričakovane koristi zdravila Valdoxan so zmanjšanje in postopna odprava simptomov, povezanih z depresijo.
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.
Slovenian: Od prvega tedna zdravljenja sta se nastop in kakovost spanja po oceni bolnikov signifikantno izboljšala, brez dnevne okornosti.
English: In healthy volunteers agomelatine preserved sexual function in comparison with paroxetine.
Slovenian: Pri zdravih prostovoljcih se je ob jemanju agomelatina, v primerjavi s paroksetinom, ohranjala spolna funkcija.
English: Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist.
Slovenian: Agomelatin je melatonergični agonist (receptorjev MT1 ter MT2) in antagonist receptorjev 5-HT2C.
English: The efficacy and safety of agomelatine (25 to 50mg/day) have been established in elderly depressed patients (< 75years).
Slovenian: Učinkovitost in varnost agomelatina (25 do 50 mg/dan) sta bili dokazani pri starejših bolnikih z depresijo (< 75 let).
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suiciderelated events).
Slovenian: Depresija je povezana z večjim tveganjem za pojav samomorilnih misli, samopoškodovanja in samomorilnosti (s samomorom povezani dogodki).
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).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z agomelatinom za eno ali več podskupin pediatrične populacije pri zdravljenju velikih depresivnih epizod (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Adverse reactions were usually mild or moderate and occurred within the first two weeks of treatment.
Slovenian: Neželeni učinki so bili običajno blagi ali zmerni in so se pojavljali v prvih dveh tednih zdravljenja.
English: Agomelatine is rapidly and well (≥ 80%) absorbed after oral administration.
Slovenian: Agomelatin se po peroralnem jemanju hitro in dobro (≥ 80 %) absorbira.
English: Use in paediatric population
Slovenian: Uporaba pri pediatrični populaciji
English: Potential for agomelatine to affect other medicinal products
Slovenian: Možen vpliv agomelatina na druga zdravila
English: 92284 Suresnes cedex - France
Slovenian: 92284 Suresnes cedex
English: Pharmacotherapeutic group: Psychoanaleptics, other antidepressants, ATC-code: N06AX22 Mechanism of action
Slovenian: Farmakoterapevtska skupina: psihoanaleptiki, drugi antidepresivi, oznaka ATC: N06AX22 Mehanizem delovanja
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
Slovenian: [EU/1/08/499/002] 14 filmsko obloženih tablet [EU/1/08/499/003] 28 filmsko obloženih tablet [EU/1/08/499/005] 56 filmsko obloženih tablet [EU/1/08/499/006] 84 filmsko obloženih tablet [EU/1/08/499/007] 98 filmsko obloženih tablet [EU/1/08/499/008] 100 filmsko obloženih tablet
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
Slovenian: 14 filmsko obloženih tablet 28 filmsko obloženih tablet 56 filmsko obloženih tablet 84 filmsko obloženih tablet 98 filmsko obloženih tablet 100 filmsko obloženih tablet
English: The bioavailability is increased by intake of oral contraceptives and reduced by smoking.
Slovenian: Biološka uporabnost se zveča ob jemanju peroralnih kontraceptivov in zmanjša ob kajenju.
English: The major metabolites, hydroxylated and demethylated agomelatine, are not active and are rapidly conjugated and eliminated in the urine.
Slovenian: Poglavitna presnovka, hidroksilirani in demetilirani agomelatin, nista aktivna ter se hitro konjugirata in odstranita iz telesa z urinom.
English: No specific antidotes for agomelatine are known.
Slovenian: Specifični antidoti za agomelatin niso znani.
English: Excretion is mainly (80%) urinary and in the form of metabolites, whereas unchanged compound recovery in urine is negligible.
Slovenian: Izločanje poteka predvsem z urinom (80 %) v obliki presnovkov, medtem ko je izločanje nespremenjene učinkovine z urinom zanemarljivo.
English: Orange-yellow, oblong, 9.5 mm long, 5.1 mm wide film-coated tablet with blue imprint of company logo on one side.
Slovenian: Oranžnorumena, podolgovata, 9,5 mm dolga in 5,1 mm široka filmsko obložena tableta z modrim odtisom logotipa podjetja na eni strani.
English: Agomelatine did not show proconvulsive properties at ip doses up to 128 mg/kg in mice and rats.
Slovenian: Agomelatin ni imel prokonvulzivnih lastnosti v intraperitonealnih odmerkih do 128 mg/kg pri miših in podganah.
English: These effects are usually mild to moderate and disappear spontaneously within a few days.
Slovenian: Ti neželeni učinki so običajno blagi do zmerni in izginejo v nekaj dneh.
English: Agomelatine increases noradrenaline and dopamine release specifically in the frontal cortex and has no influence on the extracellular levels of serotonin.
Slovenian: Agomelatin zvečuje sproščanje noradrenalina in dopamina specifično v prefrontalni skorji ter nima vpliva na zunajcelično vrednost serotonina.
English: Food intake (standard meal or high fat meal) does not modify the bioavailability or the absorption rate.
Slovenian: Uživanje hrane (standardnih obrokov ali takšnih z veliko maščobami) ne vpliva na biološko uporabnost ali stopnjo absorpcije.
English: Most side effects are mild or moderate.
Slovenian: Večina neželenih učinkov je blaga ali zmerna.
English: The Patient's Booklet should contain the following key messages:
Slovenian: Priročnik o predpisovanju za zdravnike mora vsebovati naslednja ključna sporočila:
English: Tolerability of agomelatine in elderly patients was comparable to that seen in the younger adults.
Slovenian: Prenašanje agomelatina pri starejših bolnikih je bilo primerljivo kot pri mlajših odraslih.
English: * Few cases resulting in liver transplantation or death have been reported.
Slovenian: * Poročali so o nekaj primerih s transplantacijo jeter ali smrtnim izidom.
English: Increased gamma-glutamyltransferase* (GGT)(>3 times the upper limit of the normal range
Slovenian: občasni zvišana gama-glutamiltransferaza* (GGT) (> 3-kratno zgornjo mejo normalnih vrednosti)
English: de los Madroños, 33 -28043 Madrid, Spain
Slovenian: de los Madroños, 33 -28043 Madrid, Španija
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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Valdoxan, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
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.
Slovenian: Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, Francija Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co. Wicklow, Irska Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
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.
Slovenian: Klinična učinkovitost in varnost Učinkovitost in varnost agomelatina pri bolnikih z velikimi depresivnimi epizodami so proučevali v kliničnem programu pri 7.900 bolnikih, zdravljenih z agomelatinom.
English: Thereafter tests will be taken if the doctor finds it necessary.
Slovenian: Zdravnik bo preiskave opravljal tudi pozneje, če bo menil, da jih potrebujete.
English: Aluminium/PVC blister packed in cardboard boxes.
Slovenian: Pretisni omoti iz aluminija/polivinilklorida, pakirani v kartonastih škatlah.
English: The peak plasma concentration is reached within 1 to 2 hours.
Slovenian: Največjo koncentracijo v plazmi agomelatin doseže v 1 do 2 urah.
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.
Slovenian: Če vam zdravnik poveča odmerek na 50 mg, je treba laboratorijske preiskave izvesti ob tem povečanju in nato redno med zdravljenjem, običajno po 3 tednih, 6 tednih, 12 tednih in 24 tednih.
English: The combination of agomelatine and alcohol is not advisable.
Slovenian: Sočasno jemanje agomelatina z alkoholom ni priporočljivo.
English: No dose adaptation is required in elderly patients.
Slovenian: Prilagoditev odmerka pri starejših bolnikih ni potrebna.
English: You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet.
Slovenian: Morda bi bilo koristno, če za težave z depresijo poveste sorodniku ali dobremu prijatelju in ga prosite, da prebere to navodilo.
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).
Slovenian: Glede na rezultate preiskav se bo zdravnik odločil, ali boste prejeli oz. nadaljevali z jemanjem zdravila Valdoxan (glejte tudi poglavje 3 »Kako jemati zdravilo Valdoxan«).
English: No dose adjustment is required in relation to age (see section 5.2).
Slovenian: Prilagoditev odmerka glede na starost ni potrebna (glejte poglavje 5.2).
English: Nightmares*
Slovenian: nočne more*
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.
Slovenian: V študijah o karcinogenosti je agomelatin povzročil zvečanje pojavnosti tumorjev na jetrih pri podganah in miših v odmerkih, ki so bili vsaj 110-krat večji od terapevtskih.
English: The pooled analysis of trials using the Arizona Sexual Experience Scale (ASEX) showed that agomelatine was not associated with sexual dysfunction.
Slovenian: Zbirna analiza preskušanj z arizonsko lestvico spolne izkušnje (ASEX - Arizona Sexual Experience Scale) je pokazala, da agomelatin ni povezan s spolno disfunkcijo.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravniki, ki bodo predvidoma predpisovali ali uporabljali zdravilo Valdoxan, prejeli brošure za bolnike, da jih bodo razdelili svojim bolnikom, katerim bodo predpisali to zdravilo.
English: No relevant modification in agomelatine pharmacokinetic parameters in patients with severe renal impairment has been observed.
Slovenian: Pomembnih sprememb farmakokinetičnih parametrov agomelatina pri bolnikih s hudo ledvično okvaro niso opazili.
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.
Slovenian: Dokazali so, da je agomelatin v odmerku 25 do 50 mg enkrat na dan statistično značilno boljše kot placebo (P = 0,0001) glede poglavitnega merila izida, preprečevanja relapsov depresije, merjenega s časom do relapsa.
English: In mice, rats and monkeys sedative effects were observed after single and repeated administration at high doses.
Slovenian: Pri miših, podganah in opicah so po enkratnem in večkratnem dajanju velikih odmerkov opažali sedativne učinke.
English: Liver function tests should be performed in all patients before starting treatment.
Slovenian: Delovanje jeter morate pregledovati pri vseh bolnikih pred uvedbo zdravljenja.
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.
Slovenian: Vendar v teh preskušanjih zvečanje začetnega odmerka agomelatina, paroksetina ali fluoksetina ni bilo dovoljeno niti v primeru nezadostnega odziva.
English: Decision of dose increase has to be balanced with a higher risk of transaminases elevation.
Slovenian: Odločitev o povečanju odmerka je potrebno pretehtati glede na povečano tveganje za zvišanje vrednosti jetrnih aminotransferaz.
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).
Slovenian: - Če imate bipolarno motnjo, če ste že doživeli manične simptome ali jih začnete opažati (obdobje pretirane vznesenosti in čustvenosti), se posvetujte z zdravnikom, preden začnete jemati zdravilo ali nadaljujete z jemanjem (glejte tudi »Možni neželeni učinki« v poglavju 4).
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.
Slovenian: Znano je, da pri bolnikih s samomorom povezanimi dogodki v anamnezi, ali bolnikih, ki kažejo znatno stopnjo samomorilne miselnosti pred uvedbo zdravljenja, obstaja večje tveganje za pojav samomorilnih misli ali poskusov samomora in jih je treba med zdravljenjem skrbno spremljati.
English: Liver tumours are most likely related to enzyme induction specific to rodents.
Slovenian: Tumorji na jetrih so bili najverjetneje povezani s spodbujanjem encimov, specifičnih za glodalce.
English: What Valdoxan is and what it is used for What you need to know before you take Valdoxan How to take Valdoxan
Slovenian: Kaj je zdravilo Valdoxan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Valdoxan Kako jemati zdravilo Valdoxan
English: The incidence of relapse during the 6-months double-blind follow up period was 22% and 47% for agomelatine and placebo, respectively.
Slovenian: Pojavnost relapsov med 6-mesečnim dvojno slepim spremljanjem je znašala 22 % za agomelatin oziroma 47 % za placebo.
English: During your treatment with Valdoxan :
Slovenian: Med zdravljenjem z zdravilom Valdoxan:
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.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja je približno 35 l. Vezava na beljakovine v plazmi znaša 95 % ne glede na koncentracijo in se ne spreminja s starostjo ali pri bolnikih z ledvično okvaro.
English: In humans, agomelatine has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.
Slovenian: Pri ljudeh agomelatin povzroča pozitivne fazne premike; spodbuja začetek spanja, znižanje telesne temperature in zgodnejše izločanje melatonina.
English: In the therapeutic dose-range, agomelatine systemic exposure increases proportionally with dose.
Slovenian: V razponu terapevtskih odmerkov se sistemska izpostavljenost agomelatinu zvečuje sorazmerno z odmerkom.
English: How to switch from an antidepressant medicine (SSRI/SNRI) to Valdoxan?
Slovenian: Kako zamenjati antidepresiv iz skupine SSRI/SNRI z zdravilom Valdoxan?
English: Your depression should be treated for a sufficient period of at least 6 months to ensure that you are free of symptoms.
Slovenian: Depresijo je potrebno zdraviti dovolj dolgo obdobje vsaj 6-ih mesecev, da se zagotovi odsotnost simptomov.
English: As a precautionary measure, it is preferable to avoid the use of Valdoxan during pregnancy.
Slovenian: Zaradi previdnosti se je uporabi zdravila Valdoxan med nosečnostjo bolje izogniti.
English: Response rates were statistically significantly higher with agomelatine compared with placebo.
Slovenian: Stopnje odziva so bile v skupinah, ki so prejemale agomelatin, statistično značilno večje v primerjavi s placebom.
English: Calendar packs containing 14, 28, 56, 84 and 98 film-coated tablets.
Slovenian: Koledarska pakiranja s 14, 28, 56, 84 in 98 filmsko obloženimi tabletami.
English: Valdoxan can be taken with or without food.
Slovenian: Zdravilo Valdoxan lahko jemljete s hrano ali brez nje.
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.
Slovenian: Bolnike (in skrbnike bolnikov) je treba opozoriti, da morajo biti pozorni na kakršnokoli klinično poslabšanje, pojav samomorilnega vedenja, misli na samomor in pojav neobičajnih vedenjskih sprememb, ter da se morajo v primeru, da takšni simptomi ne minejo, nemudoma posvetovati z zdravnikom.