natgillin/translations-raw huggingface dataset:
Brintellix is not recommended in children and adolescents under 18 years due to lack of information for this age group.
Brintellix se ne preporučuje za primjenu u djece i adolescenata mlađh od 18 godina zbog nedostatka informacija za ovu starosnu skupinu.
In the dedicated study in elderly, vortioxetine was also effective in these patients.
U ispitivanju posvećenim starijim je vortioksetin također bio učinkovit u ovih bolesnika.
This leaflet was last revised in MM/YYYY Other sources of information
Ova uputa je zadnji puta revidirana u MM/GGGG Ostali izvori informacija
If you take more than the prescribed dose of Brintellix, contact your doctor or nearest hospital emergency department immediately.
Ako uzmete više od propisane doze Brintellixa, odmah se obratite svom liječniku ili hitnoj službi najbliže bolnice.
The most frequently reported symptoms were nausea and vomiting.
Najčešće prijavljeni simptomi bili su mučnina i povraćanje.
Sexual dysfunction
Spolna disfunkcija
Brintellix oral drops are not to be mixed with other medicinal products.
Brintellix oralne kapi ne smiju se miješati s drugim lijekovima.
The mean volume of distribution (Vss) is 2,600 L, indicating extensive extravascular distribution.
Srednja vrijednost volumena distribucije (Vss) je 2600 L, što upućuje na opsežnu ekstravaskularnu distribuciju.
Target organ toxicity was restricted to kidneys (rats) and liver (mice and rats).
Toksičnost ciljanih organa bila je ograničena na bubrege (štakori) i jetru (miševi i štakori).
Gastrointestinal adverse reactions, such as nausea, occurred more frequently in women than men.
Gastrointestinalne nuspojave kao što je mučnina pojavljivale su se češće u žena nego u muškaraca.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.
Možda će Vam pomoći da kažete članu obitelji ili bliskom prijatelju da ste depresivni ili imate poremećaj tjeskobe, te ih zamolite da pročitaju ovu uputu.
Patients should be monitored for the emergence of signs and symptoms of SS or NMS (see sections 4.3 and 4.5).
Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma SS-a ili NMS-a (vidjeti dijelove 4.3 i 4.5).
The bottle must be turned completely upside down.
Boca mora biti potpuno okrenuta naopako.
Not known: frequency cannot be estimated from available data - low levels of sodium in the blood (the symptoms may include feeling dizzy, weak, confused,
Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka - niska razina natrija u krvi (simpotmi mogu uključivati osjećaj omaglice, slabosti, smetenosti,
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.
Smatra se da je ova multimodalna aktivnost odgovorna za učinke slične antidepresivnim i anksiolitičkim učincima i za poboljšanje kognitivne funkcije, učenja i pamćenja što je opaženo s vortioksetinom u ispitivanjima na životinjama.
Limited data are available for patients with severe renal impairment.
Dostupni su ograničeni podaci za bolesnike sa teškim oštećenjem bubrega.
However, alcohol intake is not advisable during antidepressant treatment.
Međutim, unos alkohola se ne savjetuje tijekom liječenja antidepresivima.
Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS)
Serotoninski sindrom (SS) ili neuroleptični maligni sindrom (NMS)
Vortioxetine is highly bound to plasma proteins (98 to 99%) and the binding appears to be independent of vortioxetine plasma concentrations.
Vortioksetin pokazuje visoko vezivanje na proteine plazme (98 do 99%) te se čini da je vezivanje neovisno o koncentracijama vortioksetina u plazmi.
If no drops come out, the bottle can be tapped lightly to start the flow.
Ako se ne ispušta kapljica, bočica se može lagano kuckati da bi započela protok.
It is expected that the ingredients of Brintellix will pass into breast milk.
Očekuje se da će sastojci Brintellixa prolaziti u majčino mlijeko.
Vortioxetine is a poor P-gp substrate and inhibitor.
Vortioksetin je slabi P-gp supstrat i inhibitor.
Each drop contains 4.25 mg of ethanol.
Svaka kap sadrži 4,25 mg etanola.
The mean elimination half-life and oral clearance are 66 hours and 33 L/h, respectively.
Srednja vrijednost poluvijeka eliminacije i oralnog klirensa je 66 sati, odnosno, 33 L/h.
Seizures are a potential risk with antidepressants.
Napadaji su potencijalni rizik s antidepresivima.
If no drops come out, tap the bottle lightly to start the flow.
Ako ne izlazi nijedna kap, lagano kucnite bočicu kako biste pokrenuli protok.
The major metabolite of vortioxetine is pharmacologically inactive.
Većina metabolita vortioksetina je farmakološki neaktivna.
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).
Iako ne postoje ispitivanja koja su istražila povezanost PPHN a i liječenja vortioksetinom, ovaj mogući rizik se ne može isključiti uzimajući u obzir povezani mehanizam djelovanja (povećanje koncentracije serotonina).
Vortioxetine was not genotoxic in a standard battery of in vitro and in vivo tests.
Vortioksetin nije bio genotoksičan u standardnoj bateriji in vitro i in vivo testova.
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.
U temeljitom ispitivanju QTc-a u zdravih ispitanika pri dozama do 40 mg dnevno, nije opažen potencijal za produljenje QTc intervala.
Brintellix should not be used during pregnancy unless the doctor says it is absolutely necessary.
Brintellix se ne smije primjenjivati tijekom trudnoče, osim ako liječnik ne kaže da je apsolutno nužno.
No effect of food on the pharmacokinetics was observed (see section 4.2).
Nije opažen učinak hrane na farmakokinetiku (vidjeti dio 4.2).
ECT (electroconvulsive therapy)
EKT (elektrokonvulzivna terapija)
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.
Provedena su dva ispitivanja pozitronske emisijske tomografije (PET) u ljudi koristeći se ligandima transportera 5-HT (11C-MADAM ili 11C-DASB) da bi se kvantificirala popunjenost 5-HT transportera u mozgu u rasponu različitih razina doze.
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.
Bolesnike (kao i njegovatelje bolesnika) treba upozoriti na potrebu za nadzorom zbog moguće pojave bilo kakvog kliničkog pogoršanja, suicidalnog ponašanja ili misli i neobičnih promjena ponašanja te da odmah zatraže medicinski savjet ako se jave ovi simptomi.
Clear, nearly colourless to yellowish solution.
Bistra, gotovo bezbojna do žućkasta otopina.
2500 Valby DENMARK
2500 Valby Danska
What Brintellix is and what it is used for
Što je Brintellix i za što se koristi
The safety and efficacy of Brintellix in children and adolescents aged less than 18 years have not been established.
Sigurnost i djelotvornost Brintellixa u djece i adolescenata u dobi manjoj od 18 godina nisu još ustanovljene.
Management of overdose should consist of treating clinical symptoms and relevant monitoring.
Zbrinjavanje predoziranja se treba sastojati od liječenja kliničkih simptoma i relevantnog praćenja.
- bupropion (a medicine to treat depression also used to wean from smoking).
- bupropion (lijek za liječenje depresije koji se također koristi za odvikavanje od pušenja).
Fits are a potential risk with medicines used to treat depression.
Napadaji su potencijalni rizik s lijekovima koji se koriste za liječenje depresije.
What Brintellix looks like and contents of the pack
Kako Brintellix izgleda i sadržaj pakiranja
Vortioxetine did not increase the incidence of insomnia or somnolence relative to placebo.
Vortioksetin nije povećao incidenciju nesanice ili somnolencije, u odnosu na placebo.
The reactions were usually temporary and did not lead to cessation of therapy.
Reakcije su obično bile privremene te nisu vodile do prekida terapije.
Vortioxetine has not shown any clinically significant effect on ECG parameters, including the QT, QTc, PR and QRS intervals, in patients with MDD.
Vortioksetin nije pokazao nikakav klinički značajan učinak na parametre EKG-a, uključujući QT, QTc, PR i QRS intervale u bolesnika s MDD.
If this occurs, treatment with vortioxetine should be discontinued immediately and symptomatic treatment should be initiated.
Ako se to dogodi, liječenje vortioksetinom treba odmah prekinuti te započeti simptomatsko liječenje.
The reactions were usually transient and did not generally lead to cessation of therapy.
Reakcije su obično bile prolazne te općenito nisu vodile do prekida terapije.
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.
Poznato je da bolesnici s anamnezom događaja povezanih sa samoubojstvom ili oni koji pokazuju značajan stupanj suicidalnih ideacija prije početka liječenja imaju veći rizik od suicidalnih misli ili pokušaja samoubojstva te bi trebali biti pažljivo praćeni tijekom liječenja.
Night sweats
- noćno znojenje
If you have taken any of these medicines, you will need to wait 14 days before you start taking Brintellix.
Ako ste uzimali bilo koji od ovih lijekova potrebno je pričekati 14 dana prije nego počnete uzimati Brintellix.
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.
Međutim, točan doprinos učinka na pojedinačne ciljne receptore u opaženom farmakodinamičkom profilu ostaje nejasan i oprez je potreban kada se ekstrapoliraju podaci sa životinja na čovjeka.
The list is based on information from clinical trials and post-marketing experience.
Lista se temelji na podacima iz kliničkih ispitivanja i razdoblju nakon stavljanja lijeka u promet.
Caution should therefore be exercised (see section 5.2).
Stoga je potreban oprez (vidjeti dio 5.2).
There are limited data from the use of vortioxetine in pregnant women.
Ograničeni su podaci o primjeni vortioksetina u trudnica.
Taking into account the PRAC Assessment Report on the PSUR(s) for vortioxetine, the scientific conclusions of CHMP are as follows:
Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za vortioksetin, znanstveni zaključci CHMP-a su sljedeći:
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).
Ne preporučuje se primjena Brintellixa za liječenje depresije u bolesnika u dobi manjoj od 18 godina s obzirom da sigurnost i djelotvornost vortioksetina nisu ustanovljene u ovoj dobnoj skupini (vidjeti dio 4.2).
These included salivation (rat and dog), pupil dilatation (dog), and two incidences of convulsions in dogs in the general toxicity study programme.
To je uključivalo salivaciju (štakor i pas), širenje zjenica (pas) i dvije pojave konvulzija u pasa u programu ispitivanja općenite toksičnosti.
The maintenance of antidepressant efficacy was also demonstrated in this patient population in the long-term relapse prevention study.
Održavanje antidepresivne djelotvornosti je bilo pokazano u ovoj skupini bolesnika u dugoročnom ispitivanju prevencije relapsa.
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.
Smatra se da je mehanizam djelovanja vortioksetina povezan s izravnom modulacijom aktivnosti serotonergičkih receptora i inhibicijom transportera serotonina (5-HT).
Brintellix contains ethanol.
Brintellix sadrži etanol.
Co-administration resulted in a higher incidence of adverse reactions when bupropion was added to vortioxetine than when vortioxetine was added to bupropion.
Istodobna primjena rezultirala je većom incidencijom nuspojava kada se bupropion dodao vortioksetinu nego kad se vortioksetin dodao bupropionu.
A no-effect level for convulsions was established with a corresponding safety margin of 5 considering the maximum recommended therapeutic dose of 20 mg/day.
Razina bez učinaka za konvulzije je ustanovljena s odgovarajućom sigurnosnom marginom od 5, uzimajući u obzir maksimalnu preporučenu terapijsku dozu od 20 mg/dan.
Combining this medicine with alcohol is not advisable.
Ne savjetuje se primjena ovog lijeka s alkoholom.
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.
Nije bilo klinički relevantne razlike u usporedbi s placebom u incidenciji ili prirodi simptoma prestanka liječenja, bilo nakon kratkoročnog (6-12 tjedana) ili dugoročnog (24-64 tjedna) liječenja vortioksetinom.
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.
Srednja vrijednost popunjenosti 5-HT transportera u raphe nuclei bila je približno 50% pri 5 mg/dan, 65% pri 10 mg/dan te se povećala na više od 80% pri 20 mg/dan.
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).
Nadalje, vortioksetin je u rasponu doza od 5-20 mg/dan, pokazao djelotvornost za široki raspon depresivnih simptoma (procijenjeno pomoću poboljšanja u svim MADRS rezultatima s jednom stavkom).
Approximately 2/3 of the inactive vortioxetine metabolites are excreted in the urine and approximately 1/3 in the faeces.
Približno 2/3 neaktivnog metabolita vortioksetina izlučuje se u urinu i približno 1/3 u fecesu.
In juvenile toxicity studies in rats, all vortioxetine treatment-related findings were consistent with those noted in adult animals.
U ispitivanjima juvenilne toksičnosti u štakora sva otkrića povezana s liječenjem vortioksetinom bila su konzistentna s onim opaženim u odraslih životinja.
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).
Epidemiološki podaci upućuju na to da primjena SSRI-a u trudnoći, osobito u kasnoj trudnoći, može povećati rizik od perzistentne plućne hipertenzije u novorođenčeta (PPHN).
An increased risk of bone fractures has been observed in patients taking this type of medicines.
Opažen je povećan rizik od prijeloma kostiju kod bolesnika koji uzimaju ovu vrstu lijekova.
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).
Djelotvornost i sigurnost vortioksetina ispitivane su u kliničkom programu koji je uključivao više od 6700 bolesnika, od kojih je više od 3700 bilo liječeno vortioksetinom u kratkoročnim ispitivanjima (≤12 tjedana) velikog depresivnog poremećaja (engl. major depresive disorder, MDD).
Brintellix can be taken with or without food.
Brintellix možete uzeti sa ili bez hrane.
The plasma concentration of vortioxetine was approximately two times higher in CYP2D6 poor metabolisers than in extensive metabolisers.
Koncentracija vortioksetina u plazmi bila je približno dva puta veća kod slabih metabolizatora CYP2D6, nego kod opsežnih metabolizatora.
Brintellix has no or negligible influence on the ability to drive and use machines.
Brintellix nema ili ima neznatan utjecaj na sposobnost upravljanja vozilima i rada na strojevima.
Vortioxetine is slowly, but well absorbed after oral administration and the peak plasma concentration is reached within 7 to 11 hours.
Vortioksetin se polako, ali dobro apsorbira nakon peroralne primjene te se vršne koncentracije u plazmi postižu unutar 7 do 11 sati.
Steady-state plasma concentrations are achieved in approximately 2 weeks.
Stanje dinamičke ravnoteže koncentracija u plazmi postiže se za približno 2 tjedna.
Vortioxetine had no effect relative to placebo on body weight, heart rate, or blood pressure in clinical short- and long-term studies.
Vortioksetin nije imao učinka u odnosu na placebo na tjelesnu težinu, brzinu rada srca ili krvni tlak u kratkoročnim i dugoročnim kliničkim ispitivanjima.
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.
Neklinički podaci upućuju na to da je vortioksetin antagonist receptora 5-HT3, 5-HT7 i 5-HT1D, djelomični agonist receptora 5-HT1B, agonist receptora 5-HT1A i inhibitor transportera 5-HT, što vodi do modulacije neurotransmisije u nekoliko sustava, uključujući pretežno serotoninski ali vjerojatno također noradrenergički, dopaminski, histaminski, acetilkolinski, GABAergički i glutamatni sustav.
Acetylsalicylic acid
Acetilsalicilna kiselina
Available data in animals have shown excretion of vortioxetine/ vortioxetine metabolites in milk.
Dostupni podaci u životinja pokazuju da se vortioksetin/metaboliti vortioksetina izlučuju u mlijeko.
Administration of vortioxetine in the general toxicity studies in mice, rats and dogs was mainly associated with CNS-related clinical signs.
Primjena vortioksetina u ispitivanjima općenite toksičnosti u miševa, štakora i pasa bila je uglavnom povezana s kliničkim znakovima povezanima sa SŽS-om.
However, the 20 mg dose of vortioxetine was associated with an increase in sexual dysfunction (TESD)(see section 5.1) .
Međutim, doza od 20 mg vortioksetina je bila povezana s povećanjem spolne disfunkcije (vidjeti dio 5.1).
Pharmacotherapeutic group: Psychoanaleptics; Other antidepressants, ATC-code: N06AX26
Farmakoterapijska skupina: Psihoanaleptici; Ostali antidepresivi, ATK oznaka: N06AX26
Brintellix is not to be used during breast-feeding.
Brintellix se ne smije koristiti tijekom dojenja.
* Based on post-marketing cases
* Na osnovi slučajeva nakon stavljanja lijeka u promet
Vortioxetine was statistically significantly better than agomelatine as measured by improvement in the MADRS total score and supported by the clinical relevance as demonstrated by the proportions of responders and remitters and improvement in the CGI-I.
Vortioksetin je bio statistički značajno bolji od agomelatina, mjereno poboljšanjem u ukupnom rezultatu MADRS i podržano kliničkom relevantnošću kako je pokazano razmjerima onih koji su odgovorili i koji su u remisiji te poboljšanjem u rezultatu na CGI-I.
The risk of SS or NMS is increased with concomitant use of serotonergic-active substances (including triptans), medicinal products that impair the metabolism of serotonin (including MAOIs), antipsychotics, and other dopamine antagonists.
Rizik od SS-a ili NMS-a se povećava s istodobnom primjenom serotonergičkih djelatnih tvari (uključujući triptane), lijekova koji sprječavaju metabolizam serotonina (uključujući MAOI-e), antipsihotika i drugih antagonista dopamina.
Only negligible amounts of vortioxetine are excreted in the faeces.
Samo zanemarive količine vortioksetina se izlučuju u fecesu.
- have had mania.
- ste imali napadaje.
In clinical short- and long-term placebo-controlled studies, potential discontinuation symptoms were systematically evaluated after abrupt treatment cessation of vortioxetine.
U kliničkim kratkoročnim i dugoročnim placebom kontroliranim ispitivanjima, mogući simptomi prestanka liječenja bili su sustavno procjenjivani nakon naklog prekida liječenja vortioksetinom.
Potential for vortioxetine to affect other medicinal products
Mogućnost da vortioksetin utječe na druge lijekove
Have the bottle and any remaining solution available.
Imajte sa sobom bočicu i sve preostalu otopinu.
One study assessed the effect of vortioxetine on functional capacity using the University of California San Diego Performance-Based Skills Assessment (UPSA).
Jedno ispitivanje je ocjenjivalo učinak vortioksetina na funkcionalne sposobnosti koristeći Ocjenu vještina temeljenu na izvedbi Sveučilišta California San Diego (UPSA).
There is no clinical experience with concurrent administration of vortioxetine and ECT, therefore caution is advisable.
Ne postoji kliničko iskustvo s istodobnom primjenom vortioksetina i EKT-a, stoga se savjetuje oprez.
Patients treated with vortioxetine can abruptly stop taking the medicinal product without the need for a gradual reduction in dose (see section 5.1).
Bolesnici koji se liječe vortioksetinom mogu naglo prekinuti uzimati lijek bez potrebe za postupnim smanjivanjem doze (vidjeti dio 5.1).
However, there have been reports of enhanced effects when antidepressants with serotonergic effect have been given together with lithium or tryptophan; therefore, concomitant use of vortioxetine with these medicinal products should be undertaken with caution.
Međutim, bilo je slučajeva pojačanih učinaka kada su se antidepresivi sa serotonergičkim učinkom davali zajedno s litijem ili triptofanom; stoga se istodobna primjena vortioksetina s ovim lijekovima treba provoditi s oprezom.
Hypromellose Macrogol 400
Hipromeloza Makrogol 400
The pharmacokinetics are linear and time independent in the dose range studied (2.5 to 60 mg/day).
Farmakokinetika je linearna i neovisna o vremenu u ispitivanom rasponu doza (2,5 do 60 mg/dan).
Data on the use of Brintellix in elderly patients with major depressive episodes are limited.
Podaci o primjeni Brintellixa u starijih bolesnika sa velikim depresivnim poremećajem su ograničeni.
Environmental risk assessment studies have shown that vortioxetine has the potential to be pesistent, bioaccumulative and toxic to the environment (risk to fish).
Studije procjene rizika po okoliš pokazale su da vortioksetin može biti postojan, bioakumulativan i toksičan za okoliš (rizik za ribe).
However, caution should be exercised when vortioxetine is combined with oral anticoagulants or antiplatelet medicinal products due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction (see section 4.4).
Međutim, treba biti oprezan kada se vortioksetin primjenjuje u kombinaciji s oralnim antikoagulansima ili antitrombocitnim lijekovima zbog mogućeg povećanog rizika od krvarenja, što se može pripisati farmakodinamičkoj interakciji (vidjeti dio 4.4).
The safety and tolerability of vortioxetine have been established in short- and long-term studies across the dose range of 5 to 20 mg/day.
Sigurnost i podnošljivost vortioksetina ustanovljene su u kratkoročnim i dugoročnim ispitivanjima kroz raspon doza od 5 do 20 mg/dan.
Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily.
Ovisno o individualnom odgovoru bolesnika, dozu se može povećati do maksimalno 20 mg vortioksetina jednom dnevno ili smanjiti na minimalno 5 mg vortioksetina jednom dnevno.
Potential for other medicinal products to affect vortioxetine
Mogućnost da drugi lijekovi utječu na vortioksetin
Nausea was usually mild or moderate and occurred within the first two weeks of treatment.
Nuspojave su bile obično blage ili umjerene te su se javile unutar prva dva tjedna liječenja.