FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of medicinal products with serotonergic effect (e.g., tramadol, sumatriptan and other triptans) may lead to serotonin syndrome (see section 4.4).
Slovenian: Sočasna uporaba zdravil s serotonergičnim učinkom (npr. tramadol, sumatriptan in drugi triptani) lahko privede do serotoninskega sindroma (glejte poglavje 4.4).
English: The maintenance of antidepressant efficacy was also demonstrated in this patient population in the long-term relapse prevention study.
Slovenian: V dolgoročni študiji o preprečevanju relapsov je bilo tudi dokazano vzdrževanje antidepresivne učinkovitosti pri tej skupini bolnikov.
English: 5 mg corresponding to 5 drops.
Slovenian: 5 mg ustreza 5 kapljicam.
English: What you need to know before you take Brintellix Do not take Brintellix:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Brintellix
English: - phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (medicines to treat depression called non-selective monoamine oxidase inhibitors); you must not take any of these medicines together with Brintellix.
Slovenian: - fenelzin, iproniazid, isokarboksazid, nialamid, tranilcipromin (zdravila za zdravljenje depresije imenovana neselektivni ireverzibilni zaviralci monoaminooksidaze); nobenega od teh zdravil ne smete jemati skupaj z zdravilom Brintellix.
English: Consequently, it was concluded that rash should be included as an adverse drug reaction in the product information of vortioxetine.
Slovenian: Posledično so sklenili, da je mogoče izpuščaj vključiti kot neželeni učinek zdravila v infomacije o zdravilu za vortioksetin.
English: Microcrystalline cellulose Hydroxypropylcellulose Sodium starch glycolate (type A) Magnesium stearate
Slovenian: Jedro tablete manitol mikrokristalna celuloza hidroksipropilceluloza natrijev karboksimetilškrob (vrsta A) magnezijev stearat
English: No dose adjustment is needed (see section 4.2).
Slovenian: Prilagajanje odmerka ni potrebno (glejte poglavje 4.2).
English: Lundbeck GmbH Tel: +49 40 23649 0
Slovenian: Deutschland Lundbeck GmbH Tel: +49 40 23649 0
English: Each bottle contains 15 ml Brintellix oral drops, solution.
Slovenian: Ena steklenica vsebuje 15 ml zdravila Brintellix peroralne kapljice, raztopina.
English: No effect on the pharmacokinetics of vortioxetine or ethanol and no significant impairment, relative to placebo, in cognitive function were observed when vortioxetine in a single dose of 20 mg or 40 mg was co-administered with a single dose of ethanol (0.6 g/kg) in healthy subjects.
Slovenian: Pri zdravih osebah niso opazili učinka na farmakokinetiko vortioksetina ali etanola ali pomembnega poslabšanja kognitivne funkcije pri sočasni uporabi vortioksetina v enkratnem odmerku 20 ali 40 mg in enkratnega odmerka etanola 0,6 g/kg, v primerjavi s placebom.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Questionnaire) (subjektivna merila)
English: (DSST), ranging from Δ = 1.75 (p = 0.019) to 4.26 (p <0.0001) in the 2 studies in adults and Δ = 2.79
Slovenian: Vortioksetin je imel statistično značilen učinek v primerjavi s placebom na testu zamenjave številčnih simbolov (DSST), v območju od 1,75 (p = 0,019) do 4,26 (p < 0,0001) v 2 študijah pri odraslih in Δ = 2,79 (p = 0,023) v študiji pri starejših.
English: Following multiple doses of vortioxetine, no inhibitory effect was observed in healthy subjects for the cytochrome P450 isozymes CYP2C19 (omeprazole, diazepam), CYP3A4/5 (ethinyl estradiol, midazolam), CYP2B6 (bupropion), CYP2C9 (tolbutamide, S-warfarin), CYP1A2 (caffeine) or CYP2D6 (dextromethorphan).
Slovenian: Pri zdravih osebah niso opazili inhibicijskega učinka večkratnih odmerkov vortioksetina na izoencime citokroma P450 CYP2C19 (omeprazol, diazepam), CYP3A4/5 (etinilestradiol, midazolam), CYP2B6 (bupropion), CYP2C9 (tolbutamid, S-varfarin), CYP1A2 (kofein) ali CYP2D6 (dekstrametorfan).
English: Treatment should be discontinued in any patient who develops fits or where there is an increase in the frequency of fits.
Slovenian: Zdravljenje je treba prekiniti pri vseh bolnikih, ki dobijo krče ali če se poveča njihova pogostnost.
English: - The active substance is vortioxetine.
Slovenian: - Učinkovina je vortioksetin.
English: No dose adjustment is needed (see section 4.4).
Slovenian: Prilagajanje odmerka ni potrebno (glejte poglavje 4.4).
English: - lithium (a medicine to treat depression and mental disorders) or tryptophan.
Slovenian: - litij (zdravilo za zdravljenje depresije in duševnih motenj) in triptofan.
English: Lundbeck Limited Tel: +44 1908 64 9966
Slovenian: United Kingdom Lundbeck Limited Tel: +44 1908 64 9966
English: Night sweats
Slovenian: Nočno potenje
English: Each drop contains 4.25 mg of ethanol.
Slovenian: Pomožne snovi z znanim učinkom: ena kapljica vsebuje 4,25 mg etanola.
English: How to take Brintellix
Slovenian: Kako jemati zdravilo Brintellix
English: Irreversible, selective MAO-B inhibitor (selegiline, rasagiline) Although a lower risk of serotonin syndrome is expected with selective MAO-B inhibitors than with MAO-A inhibitors, the combination of vortioxetine with irreversible MAO-B inhibitors, such as selegiline or rasagiline should be administered with caution.
Slovenian: Čeprav se s selektivnimi zaviralci MAO-B pričakuje manjše tveganje za serotoninski sindrom kot z zaviralci MAO-A, je treba kombinacijo vortioksetina z ireverzibilnimi zaviralci MAO-B, kakršna sta selegilin in razagilin, uporabljati previdno.
English: Caution is advised when concomitantly using other medicinal products capable of lowering the seizure threshold [e.g., antidepressants (tricyclics, SSRIs, SNRIs), neuroleptics (phenothiazines, thioxanthenes and butyrophenones), mefloquine, bupropion, tramadol] (see section 4.4).
Slovenian: Previdnost je priporočljiva ob sočasni uporabi drugih zdravil, ki lahko znižujejo prag za pojav epileptičnih napadov [npr. antidepresivi (triciklični, SSRI, SNRI), nevroleptiki (fenotiazini, tioksanteni in butirofenoni), meflokin, bupropion in tramadol] (glejte poglavje 4.4).
English: Discontinuation of vortioxetine should be considered in patients with symptomatic hyponatraemia and appropriate medical intervention should be instituted.
Slovenian: Pri bolnikih s simptomatsko hiponatriemijo je treba prenehati z uporabo vortioksetina in začeti z ustreznim zdravljenjem.
English: Vistor hf. Tel: +354 535 7000
Slovenian: Tel: +354 535 7000
English: Your doctor will make a decision on whether you should stop breast-feeding, or stop using Brintellix taking into account the benefit of breast-feeding for your child, and the benefit of therapy for you.
Slovenian: Vaš zdravnik se bo odločil, ali morate prenehati z dojenjem ali z jemanjem zdravila Brintellix, pri čemer bo pretehtal prednosti dojenja za vašega otroka in prednosti zdravljenja za vas.
English: - Keep this leaflet.
Slovenian: Glejte odtis na robu.
English: 10 mg corresponding to 10 drops.
Slovenian: 10 mg ustreza 10 kapljicam.
English: Hydroxypropylbetadex Ethanol (96 per cent) Purified water
Slovenian: 6.1 Seznam pomožnih snovi hidroksipropilbetadeks etanol, 96 odstotni prečiščena voda
English: Irreversible non-selective MAOIs
Slovenian: Neselektivni ireverzibilni zaviralci MAO
English: Concomitant use of antidepressants with serotonergic effect and herbal remedies containing St. John's wort (Hypericum perforatum) may result in a higher incidence of adverse reactions including Serotonin Syndrome (see section 4.4).
Slovenian: Sočasna uporaba antidepresivov s serotonergičnim učinkom in zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum) lahko privede do večjega pojavljanja neželenih učinkov, vključno s serotoninskim sindromom (glejte poglavje 4.4).
English: Each drop contains vortioxetine (D,L)-lactate equivalent to 1 mg vortioxetine.
Slovenian: Ena kapljica vsebuje vortioksetinijev (D,L)-laktat, kar ustreza 1 mg vortioksetina.
English: There is limited experience with vortioxetine overdoses above 80 mg.
Slovenian: O prevelikem odmerjanju z vortioksetinom nad 80 mg je le malo izkušenj.
English: Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function [e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid (ASA)] (see section 4.5) and in patients with known bleeding tendencies/disorders.
Slovenian: Pri bolnikih, ki jemljejo zdravila proti strjevanju krvi in/ali druga zdravila, za katere je znano, da vplivajo na delovanje trombocitov [npr. atipični antipsihotiki in fenotiazini, večina tricikličnih antidepresivov, nesteroidna protivnetna zdravila (NSAID), acetilsalicilna kislina (ASA)] (glejte poglavje 4.5), ter pri bolnikih z znano nagnjenostjo h krvavitvam/motnjami krvavitev je potrebna previdnost.
English: Multipack containing 126 (9 x 14) and 490 (5 x (98x1)) film-coated tablets.
Slovenian: Večkratno pakiranje, ki vsebuje 126 (9x14) in 490 (5 x (98x1)) filmsko obloženih tablet.
English: 15 mg corresponding to 15 drops.
Slovenian: 15 mg ustreza 15 kapljicam.
English: In the meta-analysis, the overall mean difference to placebo across the studies was statistically significant: -2.3 points (p = 0.007), -3.6 points (p <0.001), and -4.6 points (p <0.001) for the 5, 10, and 20 mg/day doses, respectively; the 15 mg/day dose did not separate from placebo in the meta-analysis, but the mean difference to placebo was -2.6 points.
Slovenian: V metaanalizi je bila celotna povprečna razlika v primerjavi s placebom za vse študije statistično značilna: -2,3 točke (p = 0,007), -3,6 točke (p < 0,001) in -4,6 točke (p < 0,001) za odmerke 5, 10 in 20 mg/dan, v tem vrstnem redu.
English: Uncommon: may affect up to 1 in 100 people - flushing - night sweats
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov zardevanje nočno potenje
English: Lundbeck Hellas A.E
Slovenian: Lundbeck Hellas A.E Τηλ.
English: After stopping Brintellix, you must allow 14 days before taking any of these medicines.
Slovenian: Brintellix je potrebno počakati 14 dni, preden začnete jemati katero izmed teh zdravil.
English: Vortioxetine had a statistically significant effect versus placebo on the Digit Symbol Substitution Test
Slovenian: Učinki vortioksetina na testu zamenjave številčnih simbolov (DSST - Digit Symbol Substitution Test),
English: Each drop of solution contains 1 mg vortioxetine (as (D,L)
Slovenian: Ena kapljica raztopine vsebuje 1 mg vortioksetina (v obliki (D,L)
English: - have a tendency to bleed or bruise easily.
Slovenian: - ste nagnjeni h krvavitvam oziroma hitremu nastanku modric.
English: Haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding)
Slovenian: Krvavitev (vključno s kontuzijo, ekhimozo, epistakso, krvavitvijo iz prebavil ali nožnice)
English: Vortioxetine has not been studied in patients with severe hepatic impairment and caution should be exercised when treating these patients (see section 4.4).
Slovenian: Vortioksetin ni bil proučevan pri bolnikih s hudo jetrno okvaro, zato morate biti previdni pri zdravljenju teh bolnikov (glejte poglavje 4.4).
English: If you take medicines to treat depression, including Brintellix, during the last 3 months of your pregnancy, you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties.
Slovenian: Če jemljete zdravila za zdravljenje depresije, vključno z zdravilom Brintellix, v zadnjem trimesečju nosečnosti, morate vedeti, da se lahko pri novorojenčku pojavijo naslednji učinki: težave z dihanjem, modrikasta koža, krči, spremembe telesne temperature, težave s hranjenjem, bruhanje, nizka raven krvnega sladkorja, toge ali mlahave mišice, živahni refleksi, tresenje, nemirnost, razdražljivost, otopelost, neprestan jok, zaspanost in težave s spanjem.
English: CYP3A4 inhibitors and CYP2C9, and CYP2C19 inhibitors When vortioxetine was co-administered following 6 days of ketoconazole 400 mg/day (a CYP3A4/5 and P-glycoprotein inhibitor) or following 6 days of fluconazole 200 mg/day (a CYP2C9, CYP2C19, and CYP3A4/5 inhibitor) in healthy subjects, a 1.3-fold and 1.5-fold increase, respectively, in vortioxetine AUC was observed.
Slovenian: Pri sočasni uporabi vortioksetina in ketokonazola v odmerku 400 mg/dan (inhibitor CYP3A4/5 in P-glikoproteina) ali flukonazola v odmerku 200 mg/dan (CYP2C9, CYP2C19 in CYP3A4/5) so po 6 dnevih pri zdravih osebah opazili 1,3-kratno (s ketokonazolom) in 1,5-kratno (s flukonazolom) povečanje AUC vortioksetina.
English: Vortioxetine had no effect relative to placebo on body weight, heart rate, or blood pressure in clinical short- and long-term studies.
Slovenian: V kratko- in dolgoročnih kliničnih študijah vortioksetin ni imel vpliva, v primerjavi s placebom, na telesno maso, srčno frekvenco ali krvni tlak.
English: Lundbeck Slovensko s.r.o.
Slovenian: Slovenská republika Lundbeck Slovensko s.r.o.
English: CYP2D6 gene types
Slovenian: Genotipi CYP2D6
English: Patients with severe depression or with depression and high levels of anxiety symptoms In severely depressed patients (baseline MADRS total score ≥30) and in depressed patients with a high level of anxiety symptoms (baseline HAM-A total score ≥20) vortioxetine also demonstrated efficacy in the short-term studies in adults (the overall mean difference to placebo in MADRS total score at Week 6/8 ranged from 2.8 to 7.3 points and from 3.6 to 7.3 points, respectively,(MMRM analysis)).
Slovenian: Bolniki s hudo obliko depresije ali z depresijo in visoko stopnjo anksioznih simptomov Pri bolnikih s hudo obliko depresije (skupno število točk po lestvici MADRS ≥ 30 pri izhodišču) in depresivnih bolnikih z visoko stopnjo anksioznih simptomov (skupno število točk po lestvici HAM-A ≥ 20 pri izhodišču) je bila prav tako dokazana učinkovitost vortioksetina v kratkoročnih študijah pri odraslih (celotna povprečna razlika v primerjavi s placebom v skupnem številu točk po lestvici MADRS pri 6./8.
English: - St John's wort (hypericum perforatum) (a medicine to treat depression).
Slovenian: - šentjanževka (Hipericum perforatum) (zdravilo za zdravljenje depresije).
English: However, as adverse reactions such as dizziness have been reported, patients should exercise caution when driving or operating hazardous machinery, especially when starting treatment with vortioxetine or when changing the dose.
Slovenian: Vendar pa morajo biti bolniki previdni pri vožnji ali upravljanju s stroji, še posebej na začetku zdravljenja z vortioksetinom ali ob spremembi odmerka, saj so poročali o neželenih učinkih, kot je omotica.
English: Angioedema, Urticaria Rash
Slovenian: Angioedem, Urtikarija Izpuščaj
English: Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6 and to a minor extent CYP3A4/5 and CYP2C9, and subsequent glucuronic acid conjugation.
Slovenian: Vortioksetin se obsežno presnavlja v jetrih, primarno z oksidacijo, ki jo katalizira CYP2D6 in v manjši meri CYP3A4/5 in CYP2C9, in nadaljnjo konjugacijo glukuronske kisline.
English: The following symptoms may occur in the newborn after maternal use of a serotonergic medicinal product in the later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping.
Slovenian: Pri novorojenčkih žensk, ki so v kasnejših obdobjih nosečnosti jemale serotonergično zdravilo, so navajali naslednje učinke: dihalno stisko, cianozo, apnejo, epileptične napade, nestabilno telesno temperaturo, težave pri hranjenju, bruhanje, hipoglikemijo, hipertonijo, hipotonijo, hiperrefleksijo, tremor, živčnost, razdražljivost, letargijo, neprestan jok, zaspanost in težave s spanjem.
English: Brintellix contains the active substance vortioxetine.
Slovenian: Zdravilo Brintellix vsebuje zdravilno učinkovino vortioksetin.
English: If the combination proves necessary, the added medicinal product should be given with minimum dosage and under close clinical monitoring for Serotonin Syndrome (see section 4.4).
Slovenian: Če se izkaže, da je sočasna uporaba obeh zdravil nujna, je treba dodano zdravilo dati v minimalnem odmerku in pod skrbnim kliničnim spremljanjem bolnika zaradi tveganja za pojav serotoninskega sindroma (glejte poglavje 4.4).
English: Pack sizes of 7, 14, 28, 56 and 98 film-coated tablets.
Slovenian: Pakiranje s 7, 14, 28, 56 in 98 filmsko obloženimi tabletami.
English: Vortioxetine is extensively metabolised in the liver, primarily through oxidation catalysed by CYP2D6 and to a minor extent CYP3A4/5 and CYP2C9 (see section 5.2).
Slovenian: Vortioksetin se obsežno presnavlja v jetrih, primarno z oksidacijo, ki jo katalizira CYP2D6 in v manjši meri CYP3A4/5 in CYP2C9 (glejte poglavje 5.2).
English: Multipack containing 490 (5 x (98x1)) film-coated tablets.
Slovenian: Večkratno pakiranje, ki vsebuje 490 (5 x (98x1)) filmsko obloženih tablet.
English: The incidence of self-reported adverse sexual reactions was low and similar to placebo in clinical short- and long-term studies with vortioxetine.
Slovenian: V kratko- in dolgoročnih kliničnih študijah z vortioksetinom je bila incidenca poročanja o neželenih spolnih učinkih nizka in podobna kot pri placebu.
English: For elderly people 65 years of age or older, the starting dose is 5 mg vortioxetine taken once daily.
Slovenian: Za starejše bolnike, stare 65 let ali več, je začetni odmerek 5 mg vortioksetina v enkratnem dnevnem odmerku.
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Slovenian: Podatki iz kliničnih preskušanj kažejo, da pri mlajših odraslih (mlajših od 25 let) z motnjami razpoloženja med zdravljenjem z antidepresivi obstaja večje tveganje za pojav samomorilnega vedenja.
English: Brintellix 20 mg/ml [outer carton only]
Slovenian: PODATKI V BRAILLOVI PISAVI Brintellix 20 mg/ml [samo zunanja škatla] 17.
English: Vortioxetine has not been studied in patients with severe hepatic impairment and caution should be exercised when treating these patients (see section 5.2).
Slovenian: Uporabo vortioksetina niso proučevali pri bolnikih s hudo jetrno okvaro in zato je pri zdravljenju teh bolnikov potrebna previdnost (glejte poglavje 5.2).
English: Cytochrome P450 substrates
Slovenian: Substrati citokroma P450
English: The effect in the individual studies was supported by the meta-analysis (MMRM) of the mean change from baseline in MADRS total score at Week 6/8 in the short-term, placebo-controlled studies in adults.
Slovenian: Učinek v posameznih študijah je bil podprt z metaanalizo (MMRM) povprečne spremembe od izhodišča v skupnem številu točk po lestvici MADRS pri 6./8.
English: Pack sizes of 14, 28 and 98 film-coated tablets.
Slovenian: Pakiranje s 14, 28 in 98 filmsko obloženimi tabletami.
English: Interactions in CYP2D6 poor metabolisers
Slovenian: Medsebojno delovanje pri bolnikih z upočasnjeno presnovo CYP2D6
English: Oral drops, solution.
Slovenian: Peroralne kapljice, raztopina.
English: The pack sizes of 56 x 1, 98 x 1 and 490 film-coated tablets are presented in unit dose blister.
Slovenian: V škatlah s 56 x 1, 98 x 1 in 490 filmsko obloženimi tabletami se tablete nahajajo v pretisnih omotih za enkratni odmerek.
English: Caution is advised when treating patients ≥ 65 years of age with doses higher than 10 mg vortioxetine once daily for which data are limited (see section 4.4).
Slovenian: Pri zdravljenju z odmerki, višjimi od 10 mg vortioksetina enkrat na dan, je pri bolnikih, starih ≥ 65 let, potrebna previdnost, saj so podatki omejeni (glejte poglavje 4.4).
English: Cytochrome P450 inhibitors
Slovenian: Inhibitorji citokroma P450
English: The oral drops can be taken with or without food.
Slovenian: Peroralne kapljice se lahko jemlje s hrano ali brez nje.
English: Each ml of solution contains vortioxetine (D,L)-lactate equivalent to 20 mg vortioxetine.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje vortioksetinijev (D,L)-laktat v količini, ki ustreza 20 mg vortioksetina (vortioxetinum).
English: Bleeding abnormalities, such as ecchymoses, purpura and other haemorrhagic events, such as gastrointestinal or gynaecological bleeding, have been reported rarely with the use of antidepressants with serotonergic effect, including vortioxetine .
Slovenian: Pri uporabi antidepresivov s serotonergičnim učinkom, vključno z vortioksetinom, so redko poročali o nenormalnih krvavitvah, kot so ekhimoze, purpura in druge krvavitve, kot so krvavitve iz prebavil ali ginekološke krvavitve.
English: - The other ingredients are mannitol (E421), microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate (type A), magnesium stearate, hypromellose, Macrogol 400, titanium dioxide (E171), iron oxide red (E172).
Slovenian: - Druge sestavine zdravila so manitol (E421), mikrokristalna celuloza, hidroksipropilceluloza, natrijev karboksimetilškrob (vrsta A), magnezijev stearat, hipromeloza, makrogol 400, titanov dioksid (E171), rdeči železov oksid (E172).
English: Vortioxetine should be used with caution in patients with a history of mania/hypomania and should be discontinued in any patient entering a manic phase.
Slovenian: Zdravljenje z vortioksetinom je potrebno prekiniti, če bolnik preide v manično fazo.
English: Perforated unit dose blisters: PVC/PVdC/aluminium.
Slovenian: Perforirani pretisni omoti za enkratni odmerek: PVC/PVdC/aluminij.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets 100 film-coated tablets 200 film-coated tablets
Slovenian: 7 filmsko obloženih tablet 14 filmsko obloženih tablet 28 filmsko obloženih tablet 56 filmsko obloženih tablet 98 filmsko obloženih tablet 56 x 1 filmsko obložena tableta 98 x 1 filmsko obložena tableta 100 filmsko obloženih tablet 200 filmsko obloženih tablet
English: sleepy or very tired, or feeling or being sick; more serious symptoms are fainting, fits or falls) - serotonin syndrome (see section 2) - allergic reactions, that may be serious, causing swelling of the face, lips, tongue or throat,
Slovenian: Neznana pogostnost: pogostnosti iz razpoložljivih podatkov ni mogoče oceniti nizke vrednosti natrija v krvi (simptomi lahko vključujejo občutek omotičnosti, šibkosti, zmedenosti, zaspanosti ali hude utrujenosti ali pa siljenje na bruhanje oziroma bruhanje; resnejši simptomi so omedlevica, krči ali padci) serotoninski sindrom (glejte poglavje 2) alergijske reakcije, ki so lahko resne in povzročajo oteklost obraza, ustnic, jezika ali žrela, težave z dihanjem ali požiranjem in/ali nenaden padec krvnega tlaka (zaradi česar ste lahko omotični ali imate vrtoglavico) koprivnica pretirana ali nepojasnjena krvavitev (vključno z modricami, krvavitvijo iz nosu, krvavitvijo iz prebavil in nožnice) izpuščaj
English: Anticoagulants and antiplatelet medicinal products No significant effects, relative to placebo, were observed in INR, prothrombin or plasma R-/S-warfarin values following co-administration of multiple doses of vortioxetine with stable doses of warfarin in healthy subjects.
Slovenian: Pri sočasni uporabi večkratnih odmerkov vortioksetina s stalnimi odmerki varfarina pri zdravih osebah, v primerjavi s placebom, niso opazili pomembnega učinka na vrednosti INR, protrombina ali R-/S-varfarina v plazmi.
English: Pack sizes of 14, 28, 56 and 98 film-coated tablets.
Slovenian: Pakiranje s 14, 28, 56 in 98 filmsko obloženimi tabletami.
English: However, as adverse reactions such as diziness have been reported, caution is advised during such activities when beginning Brintellix treatment or changing the dose.
Slovenian: Vseeno svetujemo previdnost med takimi aktivnostmi, ko začnete z zdravljenjem z zdravilom Brintellix ali spremenite odmerek, saj so poročali o neželenih učinkih, kot je omotica.