FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised when paliperidone is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QT interval.
Slovenian: Pri predpisovanju paliperidona bolnikom z znano srčnožilno boleznijo ali s podaljšanjem intervala QT v družinski anamnezi ter pri sočasni uporabi paliperidona z drugimi zdravili, ki tudi podaljšajo interval QT, je potrebna previdnost.
English: In rat reproduction studies with oral risperidone, which is extensively converted to paliperidone in rats and humans, adverse effects were seen on the birth weight and survival of the offspring.
Slovenian: V študijah reprodukcije pri podganah z uporabo peroralnega risperidona, ki se tako pri podganah kot pri človeku v velikem obsegu pretvarja v paliperidon, so opažali neželene učinke v smislu zmanjšanja porodne teže in preživetja mladičev.
English: The following table provides recommended dose conversion regimens to allow patients previously stabilised on different doses of TREVICTA to attain similar paliperidone exposure with paliperidone prolonged release tablets.
Slovenian: V preglednici so navedene priporočene sheme odmerjanja, s katerimi lahko bolniki, ki so bili stabilizirani z različnimi odmerki zdravila TREVICTA, dosežejo podobno izpostavljenost paliperidonu tudi s tabletami paliperidona s podaljšanim sproščanjem.
English: • are aware of having dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood.
Slovenian: • veste, da imate nevarno majhno število določenih tipov belih krvnih celic, ki jih potrebujete za obrambo pred okužbo v krvi.
English: Action
Slovenian: Ukrep
English: You will receive an injection of TREVICTA in the upper arm or buttocks once every 3 months.
Slovenian: Zdravilo TREVICTA vam bodo injicirali v nadlaket ali zadnjico enkrat na 3 mesece.
English: As elderly patients may have reduced renal function, see Renal impairment below for dosing recommendations in patients with renal impairment.
Slovenian: Ker imajo lahko starejši bolniki oslabljeno delovanje ledvic, za priporočeno odmerjanje pri bolnikih z okvaro ledvic glejte odstavek Okvara ledvic spodaj.
English: Due to its extremely low water solubility, the 3-monthly formulation of paliperidone palmitate dissolves slowly after intramuscular injection before being hydrolysed to paliperidone and absorbed into the systemic circulation.
Slovenian: Zaradi izjemno majhne topnosti v vodi se paliperidonijev palmitat po intramuskularnem injiciranju 3-mesečne formulacije počasi raztaplja, nato pride do hidrolize v paliperidon in absorpcije v sistemski krvni obtok.
English: A total of 379 subjects then received a single dose of TREVICTA in either the deltoid or gluteal muscle in the open-label stabilisation phase (dose was a 3.5 multiple of the last dose of 1-monthly paliperidone palmitate).
Slovenian: Nato je skupno 379 preiskovancev med odprtim delom zdravljenja v fazi stabilizacije prejelo enkraten odmerek zdravila TREVICTA bodisi v deltoidno ali glutealno mišico (odmerek zdravila TREVICTA je bil 3,5-kratnik zadnjega odmerka 1-mesečnega paliperidonijevega palmitata).
English: Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leucopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of TREVICTA should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Slovenian: Bolnike, ki so že imeli klinično pomembno majhno število levkocitov ali z zdravilom izzvano levkopenijo/nevtropenijo, je treba v prvih mesecih zdravljenja spremljati in ob pojavu prvih znakov klinično pomembnega zmanjšanja števila levkocitov in odsotnosti drugih vzročnih dejavnikov, razmisliti o prekinitvi zdravljenja z zdravilom TREVICTA.
English: Dominating central serotonin antagonism may reduce the tendency of paliperidone to cause extrapyramidal side effects.
Slovenian: Dominantno antagonistično delovanje na serotonergične receptorje v osrednjem živčevju lahko zmanjša nagnjenost paliperidona k povzročanju ekstrapiramidnih neželenih učinkov.
English: TREVICTA can then be resumed after the patient has been adequately treated with 1-monthly paliperidone palmitate injectable preferably for four months or more.
Slovenian: Zdravilo TREVICTA je nato mogoče ponovno uvesti po tem, ko je bil bolnik ustrezno zdravljen z 1-mesečnimi injekcijami paliperidonijevega palmitata, najbolje štiri mesece ali več.
English: For subjects that met randomisation criteria at weeks 14 and 17, 1,016 were randomised in a 1:1 ratio to continue on monthly injections of 1-monthly paliperidone palmitate injectable or to switch to TREVICTA with a 3.5 multiple of the week 9 and 13 dose of 1-monthly paliperidone palmitate injectable for 48 weeks.
Slovenian: Izmed bolnikov, ki so v 14. in 17. tednu ustrezali merilom za randomizacijo, so jih 1.016 v razmerju 1:1 randomizirali tako, da so 48 tednov bodisi nadaljevali z 1-mesečnimi injekcijami paliperidonijevega palmitata ali pa so prešli na zdravilo TREVICTA z odmerkom, ki je bil 3,5-kratnik odmerka 1-mesečne injekcije paliperidonijevega palmitata v 9. in 13. tednu.
English: A minor decrease in the amount of active substance excreted unchanged in the urine suggests that there was little effect on the CYP metabolism or bioavailability of paliperidone during carbamazepine co-administration.
Slovenian: Majhno zmanjšanje količine učinkovine, ki se izloči nespremenjena z urinom, kaže, da ima sočasno jemanje s karbamazepinom majhen učinek na metabolizem, ki poteka s CYP, ali biološko uporabnost paliperidona.
English: Needles from the 1-monthly paliperidone palmitate injectable pack or other commercially available needles must not be used when administering TREVICTA (see Information intended for medical or health care professionals).
Slovenian: Igle, ki so priložene pakiranju z 1-mesečnimi injekcijami paliperidonijevega palmitata in druge na trgu dostopne igle, niso primerne in se jih ne sme uporabljati za injiciranje zdravila TREVICTA (glejte Informacije za zdravnike in drugo zdravstveno osebje).
English: Pre-filled syringe (cyclic-olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a thin wall 22G 1½ inch (0.72 mm x 38.1 mm) safety needle and a thin wall 22G 1 inch (0.72 mm x 25.4 mm) safety needle.
Slovenian: Napolnjena injekcijska brizga (kopolimer cikloolefina) z batom, varovalom in vrhnjo zaporko (iz bromobutilne gume) ter varnostna igla s tanko steno velikosti 0,72 mm x 38,1 mm (dolžine 1½ palca in velikosti 22G) in varnostna igla s tanko steno velikosti 0,72 mm x 25,4 mm (1 palec, velikost 22G).
English: As diabetes mellitus or worsening of pre-existing diabetes mellitus have been seen with patients taking this medicine, your doctor should check for signs of high blood sugar.
Slovenian: Med jemanjem tega zdravila so pri bolnikih opazili sladkorno bolezen ali njeno poslabšanje, zato bo zdravnik preverjal, če imate znake povečane koncentracije sladkorja v krvi.
English: The total exposure of paliperidone following TREVICTA administration was dose-proportional over a 175-525 mg dose range, and approximately dose-proportional for Cmax.
Slovenian: Celokupna izpostavljenost paliperidonu po injiciranju zdravila TREVICTA je sorazmerna z velikostjo odmerka v okviru odmerjanja 175-525 mg, Cmax pa je približno sorazmerna z velikostjo odmerka.
English: Administer 1-monthly paliperidone palmitate injectable, two doses one week apart (into deltoid muscle)
Slovenian: Injicirajte 1-mesečni injekciji paliperidonijevega palmitata: dva odmerka s presledkom enega tedna (v deltoidno mišico)
English: Do not remove the pouch until the syringe and needle are securely attached.
Slovenian: Zaščitnega omota ne odstranjujte, dokler ni injekcijska igla trdno nameščena na injekcijsko brizgo.
English: Paliperidone may induce orthostatic hypotension in some patients based on its alpha-adrenergic blocking activity.
Slovenian: Paliperidon lahko pri nekaterih bolnikih povzroči ortostatsko hipotenzijo, ker zavira adrenergične receptorje alfa.
English: In the clinical trials of TREVICTA, akathisia, dyskinesia, dystonia, parkinsonism, and tremor were reported in 3.9%, 0.8%, 0.9%, 3.6%, and 1.4% of subjects, respectively.
Slovenian: V kliničnih preskušanjih zdravila TREVICTA so o akatiziji poročali pri 3,9% preiskovancev, o diskineziji pri 0,8%, o distoniji pri 0,9%, o parkinsonizmu pri 3,6% in o tremorju pri 1,4% preiskovancev.
English: 90 kg or more yellow hub
Slovenian: 90 kg ali več rumeni nastavek 22G x 1 ½ palca
English: Switching from other antipsychotic medicinal products Patients should not be switched directly from other antipsychotics as 3-monthly paliperidone palmitate injectable should only be initiated after the patient is stabilised on the 1-monthly paliperidone palmitate injectable.
Slovenian: Bolniki ne smejo preiti direktno z drugih antipsihotičnih zdravil, ker se lahko 3-mesečne injekcije paliperidonijevega palmitata uvede šele potem, ko je bolnik stabilen na 1-mesečnih injekcijah paliperidonijevega palmitata.
English: • dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood
Slovenian: • nevarno majhno število določenih vrst belih krvnih celic, ki jih potrebujete v krvi za obrambo pred okužbo
English: It should be injected slowly, deep into the deltoid or gluteal muscle.
Slovenian: Zdravilo je treba injicirati počasi, globoko v deltoidno ali glutaelno mišico.
English: Caution is warranted in patients receiving both, psychostimulants (e.g., methylphenidate) and paliperidone concomitantly, as extrapyramidal symptoms could emerge when adjusting one or both medicinal products.
Slovenian: Pri bolnikih, ki sočasno prejemajo psihostimulanse (metilfenidat) in paliperidon je potrebna previdnost, ker se ob prilagajanju enega ali obeh zdravil lahko pojavijo ekstrapiramidni simptomi.
English: Caution is advised when prescribing TREVICTA with medicinal products known to prolong the QT interval, e.g., class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g., amiodarone, sotalol), some antihistaminics, some antibiotics (e.g., fluoroquinolones), some other antipsychotics and some antimalarials (e.g., mefloquine).
Slovenian: Pri predpisovanju zdravila TREVICTA skupaj z zdravili, za katere je znano, da podaljšajo interval QT, kot so antiaritmiki razreda IA (npr. kinidin, dizopiramid), antiaritmiki razreda III (npr. amiodaron, sotalol), nekateri antihistaminiki, nekateri antibiotiki (npr. fluorokinoloni), nekateri drugi antipsihotiki in nekateri antimalariki (npr. meflokin), je potrebna previdnost.
English: In the clinical trials of TREVICTA, 0.3% of subjects reported orthostatic hypotension related adverse reaction.
Slovenian: V kliničnih študijah zdravila TREVICTA je o neželenih učinkih, povezanih z ortostatsko hipotenzijo, poročalo 0,3% preiskovancev.
English: Based on population pharmacokinetic analysis, the median apparent half-life of paliperidone following TREVICTA administration over the dose range of 175-525 mg ranged from 84-95 days following deltoid injections and 118-139 days following gluteal injections.
Slovenian: Po podatkih populacijske farmakokinetične analize je mediani navidezni razpolovni čas paliperidona po odmerjanju zdravila TREVICTA v razponu od 175 do 525 mg znašal od 84 do 95 dni po injiciranju v deltoidno mišico in od 118 do 139 dni po injiciranju v glutealno mišico.
English: If you have a history of seizures, this medicine may increase your chance of experiencing them.
Slovenian: Če ste že kdaj imeli epileptične napade, lahko to zdravilo poveča tveganje za ponovitev napadov.
English: After the injection is complete, use your thumb or a flat surface to secure the needle in the safety mechanism.
Slovenian: Po končanem injiciranju s palcem ali s pritiskom ob ravno površino aktivirajte sistem za zaščito igle.
English: During an operation on the eye for cloudiness of the lens (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed.
Slovenian: Med očesno operacijo zaradi zamotnitve očesne leče (katarakta, operacija sive mrene) se lahko zgodi, da se zenica (črni krog v sredini očesa) ne širi tako, kot bi se morala.
English: • experience a severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an ‘anaphylactic reaction').
Slovenian: • se pojavi huda alergijska reakcija, za katero so značilni povišana telesna temperatura, otekanje ust, obraza, ustnic ali jezika, zasoplost, srbenje, kožni izpuščaj in včasih padec krvnega tlaka (zaradi tako imenovane anafilaktične reakcije).
English: In clinical trials of TREVICTA, 5.3% of subjects reported injection site related adverse reaction.
Slovenian: V kliničnih preskušanjih zdravila TREVICTA je o neželenih učinkih na mestu injiciranja poročalo 5,3% preiskovancev.
English: • newborn babies born to mothers who have taken TREVICTA during pregnancy may experience side effects of the drug and/or withdrawal symptoms, such as irritability, slow, or sustained muscle contractions, shaking, sleepiness, breathing, or feeding problems
Slovenian: • pri novorojenčkih mater, ki so v nosečnosti prejemale zdravilo TREVICTA, se lahko pojavijo neželeni učinki zdravila in/ali odtegnitveni simptomi, kot so razdražljivost, počasni ali dolgotrajni krči mišic, tresenje, zaspanost, težave z dihanjem in motnje hranjenja
English: Co-administration of a single dose of an oral paliperidone prolonged release tablet 12 mg with divalproex sodium prolonged release tablets (two 500 mg tablets once daily) resulted in an increase of approximately 50% in the Cmax and AUC of paliperidone, likely as a result of increased oral absorption.
Slovenian: Sočasna uporaba enkratnega 12 mg odmerka tablet peroralnega paliperidona s podaljšanim sproščanjem in tablet natrijevega divalproeksa s podaljšanim sproščanjem (dve tableti po 500 mg enkrat na dan) je za približno 50% povečala vrednosti Cmax in AUC paliperidona, kar je verjetno posledica povečane absorpcije.
English: 9/L) should discontinue TREVICTA and have their WBC followed until recovery.
Slovenian: 9/l) je treba zdravljenje z zdravilom TREVICTA ukiniti in spremljati število levkocitov do normalizacije.
English: • fainting, a restless urge to move parts of your body, dizziness upon standing, disturbance in attention, problems with speech, loss or abnormal sense of taste, reduced sensation of skin to pain and touch, a sensation of tingling, pricking, or numbness of skin
Slovenian: • omedlevica, neprestana potreba po premikanju delov telesa, omotica pri vstajanju, motnje pozornosti, težave pri govoru, izguba ali nenormalno zaznavanje okusa, zmanjšana občutljivost kože na bolečino in dotik, občutek mravljinčenja, zbadanja ali odrevenelosti kože
English: During an operation on the eye for cloudiness of the lens (cataract), the iris (the coloured part of the eye) may become floppy during surgery (known as “floppy iris syndrome”) that may lead to eye damage.
Slovenian: Med očesno operacijo zaradi zamotnitve očesne leče (katarakta, operacija sive mrene) se lahko zgodi, da šarenica (obarvani del očesa) postane ohlapna (kar imenujemo sindrom ohlapne šarenice) in to lahko povzroči poškodbo očesa.
English: The following symptoms may occur in newborn babies of mothers that have used paliperidone in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Slovenian: Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti uporabljale paliperidon, se lahko pojavijo naslednji simptomi: tresenje, okorelost in/ali šibkost mišic, zaspanost, nemir, težave z dihanjem in motnje hranjenja.
English: In the TREVICTA group, the mean change from double-blind baseline to double-blind end point was +2.90 ng/mL for males (vs. -10.26 ng/mL in the placebo group) and +7.48 ng/mL for females (vs. -32.93 ng/mL in the placebo group).
Slovenian: V skupini z zdravilom TREVICTA je bila povprečna sprememba od izhodišča dvojno slepega zdravljenja do zaključka opazovanja dvojno slepega zdravljenja +2,90 ng/ml pri moških (v primerjavi z -10,26 ng/ml v skupini s placebom) in +7,48 ng/ml pri ženskah (v primerjavi z -32,93 ng/ml v skupini s placebom).
English: One female (2.4%) in the TREVICTA group experienced an adverse reaction of amenorrhea, while no potentially prolactin related adverse reactions were noted among females in the placebo group.
Slovenian: Pri eni od bolnic (2,4%) v skupini z zdravilom TREVICTA je prišlo do neželenega učinka (amenoreje), v skupini s placebom pa niso opazili nobenega neželenega učinka, ki bi bil lahko povezan s prolaktinom.
English: Appropriate care is advised when prescribing TREVICTA to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medicinal products with anticholinergic activity or being subject to dehydration.
Slovenian: Pri predpisovanju zdravila TREVICTA bolnikom, ki se lahko znajdejo v okoliščinah, ko se poviša temperatura jedra, npr. naporna telesna vadba, izpostavljenost skrajni vročini, sočasno jemanje zdravil z antiholinergičnim delovanjem ali dehidracija, svetujemo ustrezno oskrbo.
English: In placebo-controlled trials, diabetes mellitus was reported in 0.32% in subjects treated with 1-monthly paliperidone palmitate injectable compared to a rate of 0.39% in placebo group.
Slovenian: V s placebom nadzorovanih preskušanjih so pri bolnikih, zdravljenih z 1-mesečno injekcijo paliperidonijevega palmitata poročali o sladkorni bolezni pri 0,32% bolnikov v primerjavi z 0,39% bolnikov v skupini, ki je prejemala placebo.
English: TREVICTA, when administered at doses that are 3.5-fold higher than the corresponding dose of 1-monthly paliperidone palmitate injection (see section 4.2), results in paliperidone exposures similar to those obtained with corresponding monthly doses of 1-monthly paliperidone palmitate injection and corresponding once daily doses of paliperidone prolonged release tablets.
Slovenian: Pri odmerjanju zdravila TREVICTA v odmerkih, ki so 3,5-krat večji od ustreznega odmerka 1-mesečne injekcije paliperidonijevega palmitata (glejte poglavje 4.2), je mogoče doseči podobno izpostavljenost paliperidonu kot z enkrat mesečnim dajanjem ustreznih odmerkov 1-mesečnih injekcij paliperidonijevega palmitata ali ustreznih enkrat dnevnih odmerkov paliperidona v obliki tablet s podaljšanim sproščanjem.
English: During the double-blind phase of the long-term randomised withdrawal study, elevations of prolactin to above the reference range (> 13.13 ng/mL in males and > 26.72 ng/mL in females) were noted in a higher percentage of males and females in the TREVICTA group than in the placebo group (9% vs. 3% and 5% vs. 1%, respectively).
Slovenian: Med dvojno slepo fazo zdravljenja v dolgotrajnem randomiziranem preskušanju odtegnitve zdravila so pri moških in ženskah opazili povečanje koncentracije prolaktina nad normalno vrednostjo (> 13,13 ng/ml pri moških in > 26,72 ng/ml pri ženskah) v večjem odstotku v skupini z zdravilom TREVICTA kot v skupini s placebom (9% v primerjavi s 3% pri moških in 5% v primerjavi z 1% pri ženskah).
English: Extrapyramidal symptoms (EPS) included a pooled analysis of the following terms: parkinsonism (includes extrapyramidal disorder, extrapyramidal symptoms, on and off phenomenon, Parkinson's disease, parkinsonian crisis, salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, glabellar reflex abnormal, and parkinsonian rest tremor), akathisia (includes akathisia, restlessness, hyperkinesia, and restless leg syndrome), dyskinesia (dyskinesia, chorea, movement disorder, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia (includes dystonia, cervical spasm, emprosthotonus, oculogyric crisis, oromandibular dystonia, risus sardonicus, tetany, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus), and tremor.
Slovenian: EPS so vključevali združeno analizo naslednjih terminov: parkinsonizem (vključuje ekstrapiramidne motnje, ekstrapiramidne simptome, fenomen vklop-izklop, Parkinsonovo bolezen, parkinsonsko krizo, prekomerno izločanje sline, okorelost mišic in skeleta, parkinsonizem, slinjenje, rigidnost zobatega kolesa, bradikinezijo, hipokinezijo, obraz maske, mišično napetost, akinezijo, okorel vrat, rigidnost mišic, parkinsonsko držo in nenormalni grabelarni refleks, parkinsonski tremor v mirovanju); akatizija (vključuje akatizijo, nemir, hiperkinezijo in sindrom nemirnih nog); diskinezija (vključuje diskinezijo, horeo, motnje gibanja, trzanje mišic, horeoatetozo, atetozo, in mioklonus); distonija (vključuje distonijo, spazem vratnih mišic, emprostotonus, okulogirno krizo, oromandibularno distonijo, risus sardonicus, tetanijo, hipertonijo, tortikolis, nenadzorovano krčenje mišic, kontrakture mišic, blefarospazem, okulogiracijo, paralizo jezika, obrazne krče, laringospazem, miotonijo, opistotonus, orofaringealne krče, plevrototonus, krč jezika in trizmus) ter tremor.
English: Subject-rated injection site pain based on a visual analogue scale was low and decreased in intensity over time.
Slovenian: Bolečina na mestu injiciranja, ki so jo s pomočjo vizualne analogne lestvice ocenjevali preiskovanci sami, je bila blaga, njena intenzivnost se je sčasoma zmanjšala.
English: akathisia c, sedation/ somnolence, dystonia c,
Slovenian: akatizija c, sedacija/ somnolenca, distonija c, omotičnost, diskinezija c, tremor,
English: The initiation dosing as described in the prescribing information for 1-monthly paliperidone palmitate injectable is not required.
Slovenian: Uvajalno odmerjanje, ki je opisano v povzetku glavnih značilnosti zdravila za 1-mesečne injekcije paliperidonijevega palmitata, ni potrebno.
English: • hardening of the skin
Slovenian: • zadebelitev kože
English: Prolonged release suspension for injection 1 pre-filled syringe
Slovenian: suspenzija za injiciranje s podaljšanim sproščanjem 1 napolnjena injekcijska brizga 2 igli
English: Estimated Percent of Subjects Without Relapse
Slovenian: Čas (dnevi) od randomizacije ocenjen odstotek bolnikov brez relapsa
English: • an interruption in conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval from your heart, rapid heartbeat upon standing, slow heart rate, abnormal electrical tracing of the heart (electrocardiogram or ECG), a fluttering or pounding feeling in your chest (palpitations)
Slovenian: • motnje prevajanja med zgornjimi in spodnjimi deli srca, nenormalna električna prevodnost srca, podaljšanje intervala QT v zapisu aktivnosti srca, hiter srčni utrip pri vstajanju, počasen srčni utrip, nepravilnosti v izvidu spremljanja električne aktivnosti srca (elektrokardiogram ali EKG), občutek vibriranja ali močnega utripanja ali razbijanja v prsnem košu (palpitacije)
English: • dyskinesia: This is a condition involving involuntary muscle movements, and can include repetitive, spastic or writhing movements, or twitching.
Slovenian: • diskinezija: to stanje vključuje nehotene mišične gibe, lahko vključuje ponavljajoče, krčevite ali trzajoče gibe ali trzanje.
English: TREVICTA should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted.
Slovenian: Zdravila TREVICTA ne smemo uporabljati, kadar je potreben takojšen nadzor simptomov pri akutno agitiranih ali zelo psihotičnih bolnikih.