FrancophonIA/ELRC3.0 huggingface dataset:
English: Brintellix should not be used during pregnancy unless the doctor says it is absolutely necessary.
Slovenian: Zdravila Brintellix ne smete uporabljati med nosečnostjo, razen če zdravnik pravi, da je to nujno potrebno.
English: - if you are allergic to vortioxetine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na vortioksetin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: In the majority of cases, no symptoms or mild symptoms were reported.
Slovenian: V večini primerov niso poročali o simptomih ali so poročali o blagih simptomih.
English: Taking these medicines together with Brintellix may increase the risk of serotonin syndrome.
Slovenian: Jemanje teh zdravil skupaj z zdravilom Brintellix lahko poveča tveganje za serotoninski sindrom.
English: [outer carton only] PC:
Slovenian: [samo zunanja škatla] PC:
English: In 1 case, anaphylactic shock was reported.
Slovenian: Pri 1 primeru so poročali o anafilaktičnem šoku.
English: The bottle must be turned completely upside down.
Slovenian: Steklenico je treba popolnoma obrniti navzdol.
English: Target organ toxicity was restricted to kidneys (rats) and liver (mice and rats).
Slovenian: Toksičnost za ciljne organe je bila omejena na ledvice (podgane) in jetra (miši in podgane).
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Slovenian: Depresija je povezana z večjim tveganjem za pojav samomorilnih misli, samopoškodovanja in samomorilnosti (s samomorom povezani dogodki).
English: Vortioxetine is highly bound to plasma proteins (98 to 99%) and the binding appears to be independent of vortioxetine plasma concentrations.
Slovenian: Vortioksetin je močno vezan na beljakovine v plazmi (98 do 99 %) in zdi se, da je vezava neodvisna od koncentracije vortioksetina v plazmi.
English: Side effects listed below have been reported in the following frequencies.
Slovenian: Spodaj naštete neželene učinke so poročali po naslednji pogostnosti:
English: Patients should be monitored for the emergence of signs and symptoms of SS or NMS (see sections 4.3 and 4.5).
Slovenian: Bolnike je treba spremljati glede možnih znakov in simptomov SS ali NMS (glejte poglavji 4.3 in 4.5).
English: In the dedicated study in elderly, vortioxetine was also effective in these patients.
Slovenian: V namenski študiji pri starejših bolnikih je bil vortioksetin tudi učinkovit pri teh bolnikih.
English: After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response.
Slovenian: Po odpravi depresivnih simptomov je priporočljivo nadaljevati z zdravljenjem vsaj še 6 mesecev, da se utrdi antidepresivni učinek.
English: The efficacy of vortioxetine increased with increasing dose.
Slovenian: Učinkovitost vortioksetina se povečuje s povečanjem odmerka.
English: The safety and efficacy of Brintellix in children and adolescents aged less than 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Brintellix pri otrocih in mladostnikih, mlajših od 18 let, nista dokazani.
English: Continue to take Brintellix even if it takes some time before you feel any improvement in your condition.
Slovenian: Nadaljujte z jemanjem zdravila Brintellix, četudi bo trajalo nekaj časa, preden boste občutili izboljšanje svojega stanja.
English: It is expected that the ingredients of Brintellix will pass into breast milk.
Slovenian: Pričakovati je, da bodo sestavine zdravila Brintellix prehajale v materino mleko.
English: Approximately 2/3 of the inactive vortioxetine metabolites are excreted in the urine and approximately 1/3 in the faeces.
Slovenian: Približno 2/3 neaktivnih presnovkov vortioksetina se izloči z urinom in približno 1/3 z blatom.
English: Management of overdose should consist of treating clinical symptoms and relevant monitoring.
Slovenian: Obravnavanje prevelikega odmerjanja naj vključuje zdravljenje kliničnih simptomov in relevantno spremljanje.
English: Most cases were a combination of airway and skin symptoms.
Slovenian: Večina primerov je bila kombinacija simptomov dihal in kože.
English: Have the container and any remaining tablets available.
Slovenian: Imejte vsebnik in preostale tablete pri sebi.
English: However, the precise contribution of the individual targets to the observed pharmacodynamic profile remains unclear and caution should be applied when extrapolating animal data directly to man.
Slovenian: Vendar pa natančen prispevek posameznih ciljnih receptorjev v opazovanem farmakodinamičnem profilu ostaja nejasen in potrebna je previdnost pri ekstrapolaciji podatkov iz živali neposredno na človeka.
English: These symptoms could be due to either discontinuation effects or excess serotonergic activity.
Slovenian: Ti simptomi so lahko posledica odtegnitvenih učinkov ali presežne serotonergične aktivnosti.
English: If this occurs, treatment with vortioxetine should be discontinued immediately and symptomatic treatment should be initiated.
Slovenian: Če se to zgodi, je treba zdravljenje z vortioksetinom takoj prekiniti in uvesti simptomatsko zdravljenje.
English: Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS)
Slovenian: Serotoninski sindrom (SS) ali nevroleptični maligni sindrom (NMS)
English: Brintellix should only be administered to pregnant women if the expected benefits outweigh the potential risk to the foetus.
Slovenian: Nosečnice lahko Brintellix prejmejo le, če so pričakovane koristi večje od možnega tveganja za plod.
English: Pruritus, including pruritus generalised
Slovenian: Srbenje, vključno z generaliziranim srbenjem
English: Similar effects were seen in the rabbit at sub-therapeutic exposure.
Slovenian: Podobne vplive so opazili pri kuncih pri subterapevtski izpostavljenosti.
English: The mechanism of action of vortioxetine is thought to be related to its direct modulation of serotonergic receptor activity and inhibition of the serotonin (5-HT) transporter.
Slovenian: Domneva se, da je mehanizem delovanja vortioksetina povezan z njegovo neposredno modulacijo aktivnosti serotonergičnega receptorja in inhibicijo prenašalca serotonina (5-HT).
English: Although no studies have investigated the association of PPHN with vortioxetine treatment, this potential risk cannot be ruled out taking into account the related mechanism of action (increase in serotonin concentrations).
Slovenian: Čeprav nobena študija ni preiskovala povezanosti med PPHN in zdravljenjem z vortioksetinom, tega potencialnega tveganja ni mogoče izključiti, saj je potrebno upoštevati, da gre za podoben način delovanja (povečanje koncentracij serotonina).
English: Do not stop taking Brintellix without talking with your doctor.
Slovenian: Ne prenehajte jemati zdravila Brintellix, ne da bi se posvetovali s svojim zdravnikom.
English: In a thorough QTc study in healthy subjects at doses up to 40 mg daily, no potential for the prolongation of the QTc interval was observed.
Slovenian: Pri temeljiti študiji intervala QTc pri zdravih osebah pri odmerkih do 40 mg na dan niso opazili potenciala za podaljšanje intervala QTc.
English: Based on results from conventional 2-year carcinogenicity studies in mice or rats, vortioxetine is not considered to pose a risk of carcinogenicity in humans.
Slovenian: Na osnovi rezultatov 2-letnih konvencionalnih študij kancerogenosti pri miših ali podganah vortioksetin ne predstavlja tveganja za rakotvornost pri ljudeh.
English: - medicines known to cause low sodium level.
Slovenian: - zdravila za katera je znano, da povzročajo nizko raven natrija.
English: Brintellix is not recommended in children and adolescents under 18 years due to lack of information for this age group.
Slovenian: Zdravila Brintellix ne priporočajo otrokom in mladostnikom, mlajšim od 18 let, zaradi pomanjkanja podatkov za to starostno skupino.
English: This multimodal activity is considered responsible for the antidepressant and anxiolytic-like effects and the improvement of cognitive function, learning and memory observed with vortioxetine in animal studies.
Slovenian: Domneva se, da je ta multimodalna aktivnost odgovorna za učinke, podobne učinkom antidepresivov in anksiolitikov, in za izboljšanje kognitivne funkcije, učenja in spomina, ki je bilo opaženo pri vortioksetinu v študijah na živalih.
English: ECT (electroconvulsive therapy)
Slovenian: EKT (elektrokonvulzivna terapija)
English: However, alcohol intake is not advisable during antidepressant treatment.
Slovenian: Vendar pa vnos alkohola med zdravljenjem z antidepresivom ni priporočljiv.
English: The maintenance of antidepressant efficacy was demonstrated in a relapse-prevention study.
Slovenian: Vzdrževanje antidepresivne učinkovitosti so dokazali v študiji o preprečevanju relapsov.
English: Gastrointestinal adverse reactions, such as nausea, occurred more frequently in women than men.
Slovenian: Gastrointestinalni neželeni učinki, kot je navzea, so pogostejši pri ženskah kot pri moških.
English: Steady-state plasma concentrations are achieved in approximately 2 weeks.
Slovenian: Koncentracija v plazmi v stanju dinamičnega ravnovesja je dosežena v približno 2 tednih.
English: - bupropion (a medicine to treat depression also used to wean from smoking).
Slovenian: - bupropion (zdravilo za zdravljenje depresije; uporablja se tudi za odvračanje od kajenja).
English: These included salivation (rat and dog), pupil dilatation (dog), and two incidences of convulsions in dogs in the general toxicity study programme.
Slovenian: Med njimi so bili slinjenje (podgane in psi), dilatacija zenice (psi) in dve incidenci konvulzije pri psih v programu študije splošne toksičnosti.
English: Vortioxetine is a poor P-gp substrate and inhibitor.
Slovenian: Vortioksetin je slab substrat in inhibitor P-gp.
English: Vortioxetine is slowly, but well absorbed after oral administration and the peak plasma concentration is reached within 7 to 11 hours.
Slovenian: Vortioksetin se po peroralnem jemanju počasi, vendar dobro absorbira in največja koncentracija v plazmi je dosežena v roku od 7 do 11 ur.
English: Environmental risk assessment studies have shown that vortioxetine has the potential to be pesistent, bioaccumulative and toxic to the environment (risk to fish).
Slovenian: V študijah za ocenjevanje tveganja za okolje so pokazali, da je vortioksetin potencialno obstojen, bioakumulativen in toksičen za okolje (tveganje za ribe).
English: In humans, two positron emission tomography (PET) studies have been conducted using 5-HT transporter ligands (11C-MADAM or 11C-DASB) to quantify the 5-HT transporter occupancy in the brain across different dose levels.
Slovenian: Pri ljudeh so opravili dve študiji s pozitronsko emisijsko tomografijo (PET), z uporabo ligandov prenašalca 5-HT (11C-MADAM ali 11C-DASB), za kvantifikacijo zasedenosti prenašalca 5-HT v možganih pri različnih odmerkih.
English: In juvenile toxicity studies in rats, all vortioxetine treatment-related findings were consistent with those noted in adult animals.
Slovenian: V študijah toksičnosti pri mladih podganah so bile vse ugotovitve v povezavi z zdravljenjem vortioksetina skladne s tistimi, navedene za odrasle živali.
English: Caution should therefore be exercised (see section 5.2).
Slovenian: Zato je potrebna previdnost (glejte poglavje 5.2).
English: The drops can be mixed with water, juice or other non-alcoholic drinks.
Slovenian: Kapljice se lahko mešajo z vodo, s pomarančnim sokom ali z drugimi brezalkoholnimi pijačami.
English: Furthermore, vortioxetine, in the dose range of 5-20 mg/day, demonstrated efficacy on the broad range of depressive symptoms (assessed by improvement in all MADRS single-item scores).
Slovenian: Poleg tega je vortioksetin, v razponu odmerkov od 5 do 20 mg/dan, dokazal učinkovitost pri najrazličnejših depresivnih simptomih (ocenjeno z izboljšanjem vseh točk v posamičnih postavkah po lestvici MADRS).
English: Please tell your doctor if you are taking any of the medicines above, since your doctor needs to know if you already are at risk for seizures.
Slovenian: Povejte svojemu zdravniku, če jemljete katero od zgoraj navedenih zdravil, saj mora vaš zdravnik vedeti, če pri vas že obstaja tveganje za epileptične napade.
English: Turn the bottle completely upside down.
Slovenian: Steklenico obrnite navpično navzdol.
English: In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX).
Slovenian: V kliničnih študijah je bila spolna disfunkcija ocenjena z uporabo arizonske lestvice spolne izkušnje (ASEX - Arizona Sexual Experience Scale).
English: Brintellix has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Brintellix nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Fits are a potential risk with medicines used to treat depression.
Slovenian: Krči so možno tveganje pri zdravilih, ki se uporabljajo za zdravljenje depresije.
English: The most frequently reported symptoms were nausea and vomiting.
Slovenian: Simptoma, o katerih so poročali najpogosteje, sta bila navzea in bruhanje.
English: Vortioxetine was not genotoxic in a standard battery of in vitro and in vivo tests.
Slovenian: Vortioksetin ni bil genotoksičen v seriji standardnih in vitro in in vivo testov.
English: There was no clinically relevant difference to placebo in the incidence or nature of the discontinuation symptoms after either short-term (6-12 weeks) or long-term (24-64 weeks) treatment with vortioxetine.
Slovenian: Klinično pomembnih razlik s placebom v incidenci ali naravi odtegnitvenih simptomov ni bilo, niti po kratkoročnem (6-12 tednov) niti dolgoročnem (24-64 tednov) zdravljenju z vortioksetinom.
English: Data on the use of Brintellix in elderly patients with major depressive episodes are limited.
Slovenian: Podatki o uporabi zdravila Brintellix pri starejših bolnikih z epizodami velike depresije so omejeni.
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 se pojavijo takšni simptomi, nemudoma posvetovati z zdravnikom.
English: The mean 5-HT transporter occupancy in the raphe nuclei was approximately 50% at 5 mg/day, 65% at 10 mg/day and increased to above 80% at 20 mg/day.
Slovenian: Povprečna zasedenost prenašalca 5-HT v jedrih raphe je bila približno 50 % pri odmerku 5 mg/dan, 65 % pri odmerku 10 mg/dan in se je povečala nad 80 % pri odmerku 20 mg/dan.
English: However, the 20 mg dose of vortioxetine was associated with an increase in sexual dysfunction (TESD)(see section 5.1) .
Slovenian: Vendar pa je bil odmerek 20 mg vortioksetina povezan s povišano pojavnostjo spolne disfunkcije (TESD - Treatment-Emergent Sexual Dysfunction) (glejte poglavje 5.1).
English: Class effect
Slovenian: Razredni učinek
English: No effect of food on the pharmacokinetics was observed (see section 4.2).
Slovenian: Niso opazili nobenega učinka hrane na farmakokinetiko (glejte poglavje 4.2).
English: If no drops come out, the bottle can be tapped lightly to start the flow.
Slovenian: Če nobena kapljica ne izteče, se lahko narahlo potapka po steklenici, da se začne iztekanje.
English: In general, the observed side effects were mild to moderate and occurred within the first two weeks of treatment.
Slovenian: Na splošno so bili opaženi neželeni učinki blagi do zmerni in so se pojavili v prvih dveh tednih zdravljenja.
English: Nonclinical data indicate that vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter, leading to modulation of neurotransmission in several systems, including predominantly the serotonin but probably also the norepinephrine, dopamine, histamine, acetylcholine, GABA and glutamate systems.
Slovenian: Neklinični podatki kažejo, da je vortioksetin antagonist receptorjev 5-HT3, 5-HT7 in 5-HT1D, delni antagonist receptorja 5-HT1B, agonist receptorja 5-HT1A in inhibitor prenašalca 5-HT, kar vodi do modulacije nevrotransmisije v več sistemih, vključno predvsem s serotoninskim, verjetno pa tudi z noradrenalinskim, dopaminskim, histaminskim in acetilholinskim, GABA in glutaminskim sistemom.
English: Make sure your midwife and/or doctor know you are on Brintellix.
Slovenian: Poskrbite, da babica oziroma zdravnik vesta, da se zdravite z zdravilom Brintellix.
English: There are limited data from the use of vortioxetine in pregnant women.
Slovenian: Podatki o uporabi vortioksetina pri nosečnicah so omejeni.
English: In clinical short- and long-term placebo-controlled studies, potential discontinuation symptoms were systematically evaluated after abrupt treatment cessation of vortioxetine.
Slovenian: V kratko- in dolgoročnih, placebom nadzorovanih kliničnih študijah so bili možni odtegnitveni simptomi sistematično ovrednoteni po nenadnem prenehanju zdravljenja z vortioksetinom.
English: Potential for vortioxetine to affect other medicinal products
Slovenian: Možnost vpliva vortioksetina na druga zdravila
English: The pharmacokinetics are linear and time independent in the dose range studied (2.5 to 60 mg/day).
Slovenian: Farmakokinetika je linearna in časovno neodvisna v preučevanem razponu odmerkov (2,5 do 60 mg/dan).
English: Vortioxetine did not increase the incidence of insomnia or somnolence relative to placebo.
Slovenian: Vortioksetin ni povečal incidence nespečnosti ali zaspanosti v primerjavi s placebom.
English: Nausea was 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: This was supported by clinical relevance as demonstrated by the proportions of responders and remitters and the improvement in the Clinical Global Impression - Global Improvement (CGI-I) score.
Slovenian: To je bilo podprto s kliničnim pomenom, kar so dokazali z deležem odzivnih bolnikov in bolnikov v remisiji in izboljšanjem ocene po lestvici CGI-I (Clinical Global Impression - Global Impovement).
English: If no drops come out, tap the bottle lightly to start the flow.
Slovenian: Če nobena kapljica ne izteče, narahlo potapkajte po steklenici, da sprožite iztekanje.
English: The efficacy and safety of vortioxetine have been studied in a clinical programme that included more than 6,700 patients, of whom more than 3,700 were treated with vortioxetine in short-term (≤12 weeks) studies of major depressive disorder (MDD).
Slovenian: Učinkovitost in varnost vortioksetina so preučevali v kliničnem programu, ki je vključeval več kot 6.700 bolnikov, od katerih je bilo v kratkoročnih (≤ 12 tednov) študijah več kot 3.700 bolnikov z veliko depresivno motnjo (MDD - Major Depressive Disorder) zdravljenih z vortioksetinom.
English: Brintellix is not recommended for the treatment of depression in patients aged less than 18 years since the safety and efficacy of vortioxetine have not been established in this age group (see section 4.2).
Slovenian: Zdravilo Brintellix ni priporočljivo za zdravljenje depresije pri bolnikih, ki so mlajši od 18 let, ker varnost in učinkovitost vortioksetina pri tej starostni skupini nista dokazani (glejte poglavje 4.2).
English: Epidemiological data suggest that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).
Slovenian: Epidemiološki podatki nakazujejo, da bi lahko uporaba zdravil iz skupine SSRI v nosečnosti, zlasti v pozni nosečnosti, povečala tveganje za nastanek persistentne pljučne hipertenzije pri novorojenčku (PPHN).
English: - The review of a signal for anaphylactic reaction reported a total of 40 post-marketing cases, including seven where causality with vortioxetine treatment was considered possible.
Slovenian: - V pregledu znakov za anafilaktično reakcijo so poročali o skupno 40 primerih v obdobju trženja, vključno s sedmimi, pri katerih so ocenili, da je možna vzročna povezava z vortioksetinom.
English: One study assessed the effect of vortioxetine on functional capacity using the University of California San Diego Performance-Based Skills Assessment (UPSA).
Slovenian: Ena študija je ocenjevala učinek vortioksetina na funkcionalno sposobnost z uporabo testa za ocenjevanje spretnosti, ki temelji na izvedbi Univerze Kalifornija San Diego (UPSA).
English: Available data in animals have shown excretion of vortioxetine/ vortioxetine metabolites in milk.
Slovenian: Razpoložljivi podatki pri živalih kažejo na izločanje vortioksetina/njegovih presnovkov v mleko.
English: For the 20 mg/day dose, an increase in TESD was seen compared to placebo (an incidence difference of 14.2%, 95% CI [1.4, 27.0]).
Slovenian: Za odmerek 20 mg/dan so opazili povečanje v TESD v primerjavi s placebom (razlika v incidenci 14,2 %, 95 % IZ [1,4; 27,0]).
English: The mean elimination half-life and oral clearance are 66 hours and 33 L/h, respectively.
Slovenian: Povprečni razpolovni čas izločanja je 66 ur in očistek po peroralnem odmerjanju je 33 L/h.
English: In accordance with the half-life, the accumulation index is 5 to 6 based on AUC0-24h following multiple doses of 5 to 20 mg/day.
Slovenian: V skladu z razpolovnim časom je indeks akumulacije 5 do 6 na osnovi AUC0-24h po večkratnih odmerkih od 5 do 20 mg/dan.
English: The major metabolite of vortioxetine is pharmacologically inactive.
Slovenian: Glavni presnovek vortioksetina je farmakološko neaktiven.
English: Linearity/non-linearity
Slovenian: Linerarnost/nelinearnost
English: On the basis of the scientific conclusions for vortioxetine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vortioxetine is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za vortioksetin odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) vortioksetin nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Serotonergic medicinal products
Slovenian: Serotonergična zdravila
English: When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Brintellix may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish.
Slovenian: Pri jemanju med nosečnostjo, zlasti v zadnjih treh mesecih nosečnosti, lahko zdravila, kot je zdravilo Brintellix, povečajo tveganje za hudo bolezensko stanje pri otroku, imenovano persistentna pljučna hipertenzija pri novorojenčku (PPHN), zaradi katerega otrok diha hitreje in ima modrikast videz.
English: There is no clinical experience with concurrent administration of vortioxetine and ECT, therefore caution is advisable.
Slovenian: Ni kliničnih izkušenj s sočasnim zdravljenjem z vortioksetinom in EKT, zato je priporočljiva previdnost.
English: Clear, nearly colourless to yellowish solution.
Slovenian: Bistra, skoraj brezbarvna do rumenkasta raztopina.
English: The efficacy of vortioxetine is supported by the pooled responder analysis, in which the proportion of responders ranged from 46% to 49% for vortioxetine versus 34% for placebo (p <0.01; NRI analysis).
Slovenian: Učinkovitost vortioksetina je podprta z združeno analizo sodelujočih, v kateri se je delež odzivnih bolnikov gibal od 46 % do 49 % za vortioksetin proti 34 % za placebo (p < 0,01; NRI analiza).
English: Human case reports with medicinal products from the related pharmacological class of antidepressants (SSRIs) have shown an effect on sperm quality that is reversible.
Slovenian: Poročila primerov pri ljudeh, ki so jemali antidepresive iz podobne farmakološke skupine (SSRI), so pokazala učinek na kakovost sperme, ki je reverzibilen.
English: No dose adjustment is needed.
Slovenian: Prilagajanje odmerka ni potrebno.