natgillin/translations-raw huggingface dataset:
Serotonin Syndrome symptoms include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, uncoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea). 
Simptomi serotoninskog sindroma uključuju promjene mentalnog statusa (npr. agitaciju, halucinacije, komu), autonomnu nestabilnost (npr. tahikardiju, nestabilni krvni tlak, hipertermiju), neuromuskularne aberacije (npr., hiperrefleksiju, nekoordinaciju) i/ili gastrointestinalne simptome (npr. mučninu, povraćanje, proljev).
No inhibitory or inducing effect of vortioxetine was observed in the drug-drug interaction studies for the CYP isozymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/5 (see section 4.5). 
Nije opažen inhibirajući ili induktorni učinak vortioksetina u ispitivanjima interakcije na CYP izoenzime CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ili CYP3A4/5 (vidjeti dio 4.5).
Consequently, it was concluded that rash should be included as an adverse drug reaction in the product information of vortioxetine. 
Posljedično tome, zaključeno je da osip treba biti naveden kao nuspojava u informacijama o lijeku za vortioksetin.
High-density polyethylene (HDPE) tablet container. 
Spremnik za tablete od polietilena visoke gustoće (HDPE).
Co-administration of medicinal products with serotonergic effect (e.g., tramadol, sumatriptan and other triptans) may lead to serotonin syndrome (see section 4.4). 
Istodobna primjena lijekova sa serotonergičkim učinkom (npr., tramadol, sumatriptan i drugi triptani) može dovesti do serotoninskog sindroma (vidjeti dio 4.4).
What you need to know before you take Brintellix Do not take Brintellix: 
Što morate znati prije nego počnete uzimati Brintellix
Doses of 5 to 15 mg showed no difference to placebo. 
Pokazano je da nema razlike u usporedbi s placebom za doze od 5 do 15 mg.
Overdose signs could be dizziness, nausea, diarrhoea, stomach discomfort, itching of the whole body, sleepiness and flushing. 
Znakovi predoziranja mogu biti omaglica, mučnina, proljev, nelagoda u trbuhu, svrbež cijelog tijela, pospanost i crvenilo uz osjećaj vrućine.
Uncommon: may affect up to 1 in 100 people - flushing - night sweats 
Manje često: mogu se javiti u do 1 na 100 osoba - Navale crvenila - noćno znojenje
Also, no significant inhibitory effect, relative to placebo, on platelet aggregation or pharmacokinetics of acetylsalicylic acid or salicylic acid was observed when acetylsalicylic acid 150 mg/day was co-administered following multiple doses of vortioxetine administration in healthy subjects. 
Također, nije opažen značajni inhibitorni učinak u odnosu na placebo na agregaciju trombocita ili farmakokinetiku acetilsalicilne ili salicilne kiseline, kada je acetilsalicilna kiselina 150 mg/dan istodobno primijenjena nakon višestrukih doza vortioksetina u zdravih ispitanika.
Class effect 
Učinak skupine
No effect of multiple doses of acetylsalicylic acid 150 mg/day on the multiple-dose pharmacokinetics of vortioxetine was observed in healthy subjects. 
Nije opažen učinak višekratnih doza acetilsalicilne kiseline od 150 mg/dan na farmakokinetiku višekratnih doza vortioksetina u zdravih ispitanika.
- if you are taking other medicines known for depression as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors. 
- ako uzimate druge lijekove za depresiju, kao što su neselektivni inhibitori monoaminooksidaze ili selektivni MAO-A inhobitori.
Lundbeck GmbH Tel: +49 40 23649 0 
Deutschland Lundbeck GmbH Tel: +49 40 23649 0
Pack sizes of 56 x 1 and 98 x 1 film-coated tablets. 
Veličine pakiranja od 56 x 1 i 98 x 1 filmom obloženih tableta.
Brintellix contains the active substance vortioxetine. 
Brintellix sadrži djelatnu tvar vortioksetin.
Brintellix is for oral use. 
Brintellix je namjenjen za peroralnu primjenu.
No dose adjustment is needed (see section 4.2). 
Nije potrebna prilagodba doze (vidjeti dio 4.2).
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]). 
Opaženo je povećanje spolne disfunkcije koja se javila tijekom liječenja u usporedbi s placebom (razlika u incidenciji od 14,2%, 95% CI [1,4, 27,0]) za doze od 20 mg/dan.
Brintellix oral drops, solution, are available in 20 ml amber glass bottle including screw cap with dropper (child-resistant closure). 
Brintellix oralne kapi, otopina su dostupne u jantarnim staklenim bocama od 20 ml sa zatvaračem s navojem i kapaljkom (zatvarač siguran za djecu).
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). 
Savjetuje se oprez pri istodobnoj primjeni drugih lijekova koji mogu sniziti prag napadaja [npr. antidepresiva (triciklika, SSRI-a, SNRI-a), neuroleptika (fenotiazina, tioksantena i butirofenona), meflokina, bupropiona, tramadola] (vidjeti dio 4.4).
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. 
Međutim, kako su prijavljene nuspojave kao što je omaglica, bolesnici bi trebali biti oprezni pri upravljanju vozilima ili opasnim strojevima, osobito pri početku liječenja vortioksetinom ili pri promjeni doze.
The tablet can be taken with or without food. 
Tabletu možete uzeti sa ili bez hrane.
The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years of age (see section 4.2). 
Najniža učinkovita doza od 5 mg vortioksetina, se uvijek mora koristiti kao početna doza kod bolesnika u dobi ≥65 godina (vidjeti dio 4.2).
5 mg corresponding to 5 drops. 
5 mg odgovara 5 kapi.
However, caution should be exercised when prescribing to elderly patients at doses higher than 10 mg vortioxetine once daily (see section 4.4). 
Međutim, oprez se savjetuje kada se vortioksetin propisuje starijim bolesnicima u dozama višim od 10 mg jednom dnevno (vidjeti dio 4.4).
Treatment should be discontinued in any patient who develops seizures or for whom there is an increase in seizure frequency. 
Liječenje treba prekinuti u svakog bolesnika koji razvije napadaje ili kod koga se poveća učestalost napadaja.
Lundbeck Limited Tel: +44 1908 64 9966 
United Kingdom Lundbeck Limited Tel: +44 1908 64 9966
Therefore, caution should be exercised when treating patients ≥ 65 years of age with doses higher than 10 mg vortioxetine once daily (see sections 4.2, 4.8 and 5.2). 
≥ 65 godina dozama višim od 10 mg vortioksetina jednom dnevno (vidjeti dijelove 4.2, 4.8 i 5.2).
No dose adjustment is needed (see section 4.4). 
Nije potrebna prilagodba doze (vidjeti dio 4.4).
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). 
Nakon primjene višekratnih doza vortioksetina u zdravih ispitanika nije opažen inhibitorni učinak za izoenzime CYP2C19 (omeprazol, diazepam), CYP3A4/5 (etinil estradiol, midazolam), CYP2B6 (bupropion), CYP2C9 (tolbutamid, S-varfarin), CYP1A2 (kofein) ili CYP2D6 (dekstrometorfan) citokroma P450.
The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years of age. 
Najniža učinkovita doza od 5 mg vortioksetina jednom dnevno, se uvijek mora koristiti kao početna doza kod bolesnika u dobi
No significant impairment, relative to placebo, in cognitive function was observed for vortioxetine following co-administration with a single 10 mg dose of diazepam. 
Nije bilo opaženo značajno pogoršanje kognitivne funkcije u usporedbi s placebom, nakon istodobne primjene vortioksetina i jedne doze od 10 mg diazepama.
CYP2D6 gene types 
CYP2D6 genotipi
How to store Brintellix 
Kako čuvati Brintellix
- are taking medicines with a so-called serotonergic effect, such as: - tramadol (a strong pain killer) - sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine). 
- uzimate lijekove s takozvanim serotonergičkim učinkom, kao što su: - tramadol (snažni lijek protiv bolova). sumatriptan i slični lijekovi s imenima djelatnih tvari koja završavaju na “triptani” (primjenjuju se za liječenje migrene).
Each drop contains vortioxetine (D,L)-lactate equivalent to 1 mg vortioxetine. 
Svaka kap sadrži vortioksetin (D,L)-laktat u količini koja odgovara 1 mg vortioksetina.
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). 
Istodobna primjena antidepresiva sa serotonergičkim učinkom i biljnih pripravaka koji sadržavaju gospinu travu (Hypericum perforatum) može rezultirati većom incidencijom nuspojava, uključujući serotoninski sindrom (vidjeti dio 4.4).
Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs). 
Rijetko je prijavljena hiponatremija s primjenom antidepresiva sa serotonergičkim učinkom (SSRI-i, SNRI-i), vjerojatno zbog neodgovarajućeg izlučivanja antidiuretskog hormona (SIADH).
Co-administration of strong CYP3A4/2C9-inhibitors to CYP2D6 poor metabolisers could potentially result in higher exposure (see section 4.5). 
Istodobna primjena snažnih CYP3A4/2C9 inhibitora kod slabih metabolizatora CYP2D6 bi mogla potencijalno dovesti do više izloženosti (vidjeti dio 4.5).
Effects of vortioxetine on the Digit Symbol Substitution Test (DSST), the University of California San Diego Performance-Based Skills Assessment (UPSA) (objective measures) and Perceived Deficits Questionnaire (PDQ) and Cognitive and Physical Functioning Questionnaire CPFQ (subjective measures) scores 
University of California San Diego Performance-Based Skills Assessment, UPSA) (objektivno mjerilo) i Upitnika za primijećene deficite (engl.
10 mg corresponding to 10 drops. 
10 mg odgovara 10 kapi.
Vortioxetine has not been studied in patients with severe hepatic impairment and caution should be exercised when treating these patients (see section 4.4). 
Vortioksetin nije bio ispitivan u bolesnika s teškim oštećenjem jetre te je potreban oprez pri liječenju ovih bolesnika (vidjeti dio 4.4).
15 mg corresponding to 15 drops. 
15 mg odgovara 15 kapi.
(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 
Vortioksetin je imao statistički značajan učinak naspram placeba na Testu sparivanja brojki i simbola (DSST), u rasponu od Δ=1,75 (p=0,019) do 4,26 (p<0,0001) u 2 ispitivanja u odraslih i Δ=2,79 (p=0,023) u ispitivanju u starijih osoba.
- fluoxetine, paroxetine and other medicines to treat depression called SSRI/SNRIs, tricyclics - St John's wort (hypericum perforatum)(a medicine to treat depression). 
- fluoksetin, paroksetin i drugi lijekovi za liječenje depresije koji se zovu SSRI/SNRI-i, triciklici - gospinu travu (Hypericum perforatum) (lijek za liječenje depresije). - kinidin (lijek za liječenje poremećaja srčanog ritma).
The oral drops can be taken with or without food. 
Oralne kapi se mogu uzeti sa ili bez hrane.
Medicines that increase the risk of fits: - sumatriptan and similar medicines with active substance names ending in “triptans”. 
Lijekove koji povećavaju rizik od napadaja: - sumatriptan i slični lijekovi s imenima djelatnih tvari koja završavaju na “triptani”.
In the 8-week, double-blind, placebo-controlled, fixed-dose study in elderly depressed patients (aged ≥65 years, n=452, 156 of whom were on vortioxetine), vortioxetine 5 mg/day was superior to placebo as measured by improvement in the MADRS and HAM-D24 total scores. 
U dvostruko slijepom, placebom kontrolirarnom, ispitivanju s fiksnim dozama od 8 tjedana u starijih depresivnih bolesnika (u dobi ≥65 godina, n=452 od kojih je 156 bilo na vortioksetinu), vortioksetin u dozi od 5 mg/dan je bio superioran placebu, mjereno poboljšanjem u ukupnim rezultatima MADRS i HAM-D24.
Blister: Transparent; PVC/PVdC/aluminium blister. 
Blister: proziran, PVC/PVdC/aluminij blister.
Vortioxetine has not been studied in patients with severe hepatic impairment and caution should be exercised when treating these patients (see section 5.2). 
Vortioksetin nije ispitivan u bolesnika s teškim oštećenjem jetre te je potreban oprez pri liječenju takvih bolesnika (vidjeti dio 5.2).
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. 
Nisu opaženi značajni učinci u odnosu na placebo na INR, vrijednosti protrombina ili R-/S-varfarina u plazmi nakon istodobne primjene višekratnih doza vortioksetina i stabilnih doza varfarina u zdravih ispitanika.
98 x 1 film-coated tablets 
98 x 1 filmom obloženih tableta
- sumatriptan and similar medicines with active substance names ending in “triptans” (used to treat migraine). 
- sumatriptan i slični lijekovi s imenima djelatnih tvari koja završavaju na “triptani” (primjenjuju se za liječenje migrene).
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. 
Smatra se da vortioksetin ne predstavlja rizik od kancerogenosti u ljudi na temelju rezultata konvencionalnih dvogodišnjih ispitivanja kancerogenosti u miševa ili štakora.
- 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. 
- fenelzin, iproniazid, izokarboksazid, nialamid, tranilcipromin (lijekovi za liječenje depresije koji se zovu neselektivni inhibitori monoaminooksidaze); ni jedan od tih lijekova ne smijete uzimati zajedno s
98 x 1 film-coated tablets. 
98 x 1 filmom obloženih tableta.
No clinically relevant effect was observed during steady-state lithium exposure following coadministration with multiple doses of vortioxetine in healthy subjects. 
Nije opažen klinički relevantan učinak tijekom izloženosti litiju u stanju dinamičke ravnoteže nakon istodobne primjene s višestrukim dozama vortioksetina u zdravih ispitanika.
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. 
Kada je vortioksetin istodobno primijenjen nakon 6 dana primjene ketokonazola 400 mg/dan (inhibitor CYP3A4/5 i P-glikoproteina) ili nakon 6 dana flukonazola 200 mg/dan (inhibitor CYP2C9, CYP2C19 i CYP3A4/5) u zdravih ispitanika, opaženo je povećanje od 1,3 odnosno 1,5 puta u AUC-u vortioksetina.
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). 
Ako se pokaže da je kombinacija neophodna, dodani lijek se mora davati u minimalnoj dozi i pod strogim kličkim praćenjem za serotoninski sindrom (vidjeti dio 4.4).
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. 
U novorođenčeta čije su majke uzimale serotonergičke lijekove u kasnijim stadijima trudnoće se mogu javiti sljedeći simptomi: respiratorni distres, cijanoza, apneja, napadaji, temperaturna nestabilnost, poteškoće s hranjenjem, povraćanje, hipoglikemija, hipertonija, hipotonija, hiperrefleksija, tremor, nervoza, razdražljivost, letargija, neprekidno plakanje, somnolencija i poteškoće sa spavanjem.
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). 
≥ 65 godina dozama višim od 10 mg vortioksetina jednom dnevno, za koje su podaci ograničeni (vidjeti dio 4.4).
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)). 
U teško depresivnih bolesnika (početna vrijednost MADRS ukupni rezulatat ≥30) te u depresivnih bolesnika s visokom razinom simptoma anksioznosti (početna vrijednost HAM-A ukupni rezultat ≥20) vortioksetin je, također, pokazao djelotvornost u kratkoročnim ispitivanjima u odraslih (ukupna srednja razlika od placeba u ukupnom rezultatu na MADRS u 6/8 tjednu se kretala od 2,8 do 7,3 boda, odnosno od 3,6 do 7,3 boda (MMRM analiza)).
Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS), potentially life-threatening conditions, may occur with vortioxetine. 
S vortioksetinom se mogu javiti serotoninski sindrom (SS) ili neuroleptični maligni sindrom (NMS), stanja koja su potencijalno životno ugrožavajuća.
If you take medicine 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. 
Ako uzmete lijek za liječenje depresije, uključujući Brintellix, tijekom posljednja 3 mjeseca trudnoće trebate biti svjesni sljedećih mogućih učinaka na novorođenče: poteškoće s disanjem, plavičasta koža, napadaji, promjene tjelesne temperature, poteškoće s hranjenjem, povraćanje, niski šećer u krvi, ukočeni ili mlitavi mišići, snažni refleksi, tremor, nervoza, razdražljivost, letargija, neprestano plakanje, pospanost i poteškoće sa spavanjem.
- are taking medicines with a so-called serotonergic effect, such as: - tramadol (a strong painkiller). 
- uzimate lijekove s takozvanim serotonergičkim učinkom, kao što su: - tramadol (snažni lijek protiv bolova).
Multipack: 126 (9 packs of 14) film-coated tablets. 
OBLIK I SADRŽAJ Višestruko pakiranje: 126 (9 pakiranja od 14) filmom obloženih tableta.
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. 
Vortioksetin se ekstenzivno metabolizira u jetri, primarno kroz oksidaciju kataliziranu s CYP2D6 i u manjem opsegu s CYP3A4/5 i CYP2C9 i posljedično kroz konjugaciju glukuronične kiseline.
Pack sizes of 7, 14, 28, 56 and 98 film-coated tablets. 
Veličine pakiranja od 7, 14, 28, 56 i 98 filmom obloženih tableta.
CARTON AND LABEL FOR THE TABLET CONTAINER NAME OF THE MEDICINAL PRODUCT 
KUTIJA I NALJEPNICA ZA SPREMNIK ZA TABLETE
Tell your doctor if you are taking any of the following medicines: - 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. 
Obavijestite svog liječnika ako uzimate bilo koji od sljedećih lijekova: - fenelzin, iproniazid, izokarboksazid, nialamid, tranilcipromin (lijekovi za liječenje depresije koji se zovu neselektivni inhibitori monoaminooksidaze); ni jedan od tih lijekova ne smijete uzimati zajedno s
Reversible, selective MAO-A inhibitor (moclobemide) The combination of vortioxetine with a reversible and selective MAO-A inhibitor, such as moclobemide, is contraindicated (see section 4.3). 
Kontraindicirana je kombinacija vortioksetina i reverzibilnih i selektivnih MAO-A inhibitora, poput moklobemida (vidjeti dio 4.3).
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 
7 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 56 filmom obloženih tableta 56 x 1 filmom obloženih tableta 98 filmom obloženih tableta 98 x 1 filmom obloženih tableta 100 filmom obloženih tableta 200 filmom obloženih tableta
Each drop of solution contains 1 mg vortioxetine (as (D,L) 
Svaka kap otopine sadrži 1 mg vortioksetina (u obliku (D, L) laktata).
Medicines that increase the risk of fits: - sumatriptan and similar medicines with active substance names ending in “triptans” - tramadol (a strong painkiller). 
Lijekove koji povećavaju rizik od napadaja: - sumatriptan i slični lijekovi s imenima djelatnih tvari koja završavaju na “triptani”. - tramadol (snažni lijek protiv bolova).
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. 
Savjetuje se oprez u bolesnika koji uzimaju antikoagulanse i/ili lijekove za koje je poznato da utječu na funkciju trombocita [npr. atipični antipsihotici i fenotiazini, većina tricikličkih antidepresiva, nesteroidni protuupalni lijekovi (NSAILi)), acetilsalicilna kiselina (ASK)] (vidjeti dio 4.5) te u bolesnika s poznatim sklonostima/poremećajima krvarenja.
Perforated unit dose blisters: PVC/PVdC/aluminium. 
Perforirani blisteri s jediničnim dozama: PVC/PVdC/aluminij.
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)). 
U teško depresivnih bolesnika (početna vrijednost MADRS ukupni rezulatat ≥30) te u depresivnih bolesnika s visokom razinom simptoma anksioznosti (početna vrijednost HAM-A ukupni rezultat ≥20 vortioksetin je, također, pokazao djelotvornost u kratkoročnim ispitivanjima u odraslih (ukupna srednja razlika od placeba u ukupnom rezultatu na MADRS u 6/8 tjednu se kretala od 2,8 do 7,3 boda, odnosno 3,6 do 7,3 boda (MMRM analiza)).
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 
14 filmom obloženih tableta 28 filmom obloženih tableta 56 filmom obloženih tableta 56 x 1 filmom obloženih tableta 98 filmom obloženih tableta 98 x 1 filmom obloženih tableta 100 filmom obloženih tableta 200 filmom obloženih tableta
H. Lundbeck AB Tel: +46 40 699 8200 
Lundbeck AB Tel: +46 4069 98200
The pack sizes of 56 x 1, 98 x 1 and 490 film-coated tablets are presented in unit dose blister. 
Veličine pakiranja od 56 x 1, 98 x 1 i 490 filmom obloženih tableta se nalaze u blisteru s jediničnim dozama.