FrancophonIA/ELRC3.0 huggingface dataset:
English: Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Croatian: S obzirom da paliperidon primarno utječe na središnji živčani sustav (vidjeti dio 4.8), INVEGU treba primjenjivati uz oprez u kombinaciji s drugim lijekovima s centralnim djelovanjem, npr. anksioliticima, većinom antipsihotika, hipnoticima, opijatima, itd. ili alkoholom.
English: Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when INVEGA is administered with other therapeutic agents that have this potential, e.g., other antipsychotics, tricyclics.
Croatian: Zbog potencijala lijeka INVEGA da izazove ortostatsku hipotenziju (vidjeti dio 4.4), može se uočiti aditivan učinak kad se taj lijek primjenjuje zajedno s drugim lijekovima koji imaju takav potencijal, npr. drugima antipsihoticima, tricikličkim antidepresivima.
English: Maximum mean increases of serum prolactin concentrations were generally observed on day 15 of treatment, but remained above baseline levels at study endpoint.
Croatian: Najveće prosječno povećanje koncentracije prolaktina u serumu obično se primijetilo 15. dana liječenja, ali ostalo je iznad početne razine po završetku ispitivanja.
English: The 1-7 version of the PANSS was used.
Croatian: Korištena je PANSS ljestvica, verzija 1-7.
English: However, overall the magnitude of effect in regard to PANSS and YMRS observed on monotherapy was larger than that observed with concomitant antidepressants and/or mood stabilisers.
Croatian: Međutim, cjelokupna veličina učinka na PANSS i YMRS primijećena kod monoterapije je veća nego ona primijećena kod istovremeno primjenjenih antidepresiva i/ili stabilizatora raspoloženja.
English: Paliperidone was not teratogenic in rat and rabbit.
Croatian: Paliperidon nije imao teratogene učinke na štakore i zečeve.
English: • glaucoma (increased pressure within the eyeball), increased tears, redness of the eyes, problems with movement of your eyes, eye rolling
Croatian: • glaukom (povišen tlak u očnoj jabučici), pojačano suzenje, crvenilo očiju, problemi s pokretanjem očiju, preokretanje očiju
English: Schizoaffective disorder is a mental condition in which a person experiences a combination of schizophrenia symptoms (as listed above) in addition to mood disorder symptoms (feeling very high, feeling sad, feeling agitated, distracted, sleeplessness, talkativeness, losing interest in everyday activities, sleeping too much or too little, eating too much or too little, and recurrent thoughts of suicide).
Croatian: Shizoafektivni poremećaj je mentalno stanje u kojem osoba proživljava kombinaciju simptoma shizofrenije (navedeni su gore u tekstu) dodatno uz simptome poremećaja raspoloženja (osjećaj povišenog raspoloženja, osjećaj tuge, osjećaj uzbuđenosti, rastresenosti, besanica, brbljavost, gubitak interesa za svakodnevne aktivnosti, previše ili premalo spavanja, previše ili premalo uzimanja hrane i ponavljajuće misli o samoubojstvu).
English: You may experience sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats.
Croatian: Možete osjetiti pospanost, umor, abnormalne pokrete tijela, probleme s održavanjem ravnoteže i hodom, pospanost zbog niskog krvnog tlaka i nenormalne otkucaje srca.
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.
Croatian: Neznatno smanjanje količine djelatne tvari koja se u nepromijenjenom obliku izlučuje u urinu sugerira da postoji mali učinak na metabolizam putem CYP ili na bioraspoloživost paliperidona tijekom istodobne primjene s karbamazepinom.
English: • a blockage in the bowels, stool incontinence, very hard stool, lack of bowel muscle movement that causes blockage
Croatian: • blokada crijeva, inkontinencija stolice, vrlo tvrda stolica, nedostatak pokretanja mišića crijeva što uzrokuje blokadu
English: • decrease in the type of white blood cells that help to protect you against infection, increase in eosinophils (a type of white blood cell) in your blood
Croatian: • pad vrste bijelih krvnih stanica koje pomažu u borbi protiv infekcije, povišenje eozinofila (vrsta bijelih krvnih stanica) u krvi
English: Additional side effects in adolescents
Croatian: Dodatne nuspojave u adolescenata
English: Do not store above 30 Store in the original package in order to protect from moisture.
Croatian: Ne čuvati na temperaturi iznad 30 Čuvati u originalnom pakiranju radi zaštite od vlage.
English: In adolescents weighing < 51 kg, a 23% higher exposure was observed than in adolescents weighing ≥ 51 kg. Age alone did not influence the paliperidone exposure.
Croatian: U adolescenata težine< 51 kg, bila je zapažena 23% veća izloženost nego u adolescenata težine ≥ 51 kg.
English: The study showed a significantly longer time to relapse in patients treated with the long-acting injectable formulation of paliperidone compared to placebo (p < 0.001).
Croatian: Ispitivanje je pokazalo značajno duže vrijeme do relapsa u bolesnika koji su liječeni s dugodjelujućom formulacijom paliperidona u obliku injekcije u odnosu na placebo (p < 0,001).
English: Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Croatian: Ispitivanja na kulturama stanica upućuju na to da bi rast stanica tumora dojke u ljudi mogao biti stimuliran prolaktinom.
English: The amount you take depends on how well the medicine works for you.
Croatian: Količina ovisi o tome kako će lijek djelovati na Vas.
English: Appropriate care is advised when prescribing INVEGA 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 medication with anticholinergic activity, or being subject to dehydration.
Croatian: Preporučuje se odgovarajuća skrb prilikom propisivanja lijeka INVEGA bolesnicima koji će biti izloženi uvjetima koji pridonose povišenju osnovne tjelesne temperature, npr. intenzivnom vježbanju, ekstremnim vrućinama, istodobnom uzimanju lijekova s antikolinergičkim djelovanjem ili uvjetima dehidracije.
English: • atrial fibrillation (an abnormal heart rhythm), rapid heartbeat upon standing
Croatian: • atrijska fibrilacija (nenormalan srčani ritam), brzi otkucaji srca nakon ustajanja
English: Concomitant administration of INVEGA with paroxetine, a potent CYP2D6 inhibitor, showed no clinically significant effect on the pharmacokinetics of paliperidone.
Croatian: Istodobna primjena INVEGE s paroksetinom, snažnim inhibitorom CYP2D6, nije imala klinički značajan učinak na farmakokinetiku paliperidona.
English: Refer to ‘Extrapyramidal symptoms' below.
Croatian: Vidjeti odjeljak „Ekstrapiramidalni simptomi” niže.
English: Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% in mild (Creatinine Clearance [CrCl] = 50 to < 80 mL/min), 64% in moderate (CrCl = 30 to < 50 mL/min), and 71% in severe (CrCl = < 30 mL/min) renal impairment.
Croatian: Ukupni klirens paliperidona je smanjen kod ispitanika sa smanjenom bubrežnom funkcijom za 32% u slučaju blagog (klirens kreatnina [CrCl] = 50 do < 80 ml/min), 64% kod umjerenog (CrCl = 30 do < 50ml/min) i 71% kod teškog (CrCl = < 30 ml/min) oštećenja bubrega.
English: This is because it is not known if INVEGA is safe or effective in these age groups.
Croatian: To je zato što nisu poznate sigurnost i djelotvornost lijeka INVEGA u ovim dobnim skupinama.
English: In a long-term trial designed to assess the maintenance of effect, the long-acting injectable formulation of paliperidone was significantly more effective than placebo in maintaining symptom control and delaying relapse of psychotic, manic, and depressive symptoms of schizoaffective disorder.
Croatian: U dugotrajnom ispitivanju dizajniranom za procjenu održavanja učinka, dugodjelujuća formulacija paliperidona u obliku injekcije bila je značajno učinkovitija od placeba u održavanju kontrole simptoma i odgađanju relapsa psihotičnih, maničnih i depresivnih simptoma shizoafektivnog poremećaja.
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including INVEGA, should be considered.
Croatian: Ukoliko se pojave znakovi i simptomi tardivne diskinezije, potrebno je razmotriti prekid uzimanja svih antipsihotika, uključujući i INVEGU.
English: Torsade de pointes and ventricular fibrillation have been reported in association with overdose.
Croatian: Torsade de pointes i ventrikularna fibrilacija prijavljeni su kod predoziranja.
English: In vitro studies have shown that paliperidone is a P-glycoprotein (P-gp) substrate.
Croatian: In-vitro ispitivanja su pokazala da je paliperidon P-glikoprotein (P-gp) supstrat.
English: As diabetes mellitus or worsening of pre-existing diabetes mellitus have been seen with patients taking INVEGA, your doctor should check for signs of high blood sugar.
Croatian: Budući da je u bolesnika koji uzimaju INVEGU zabilježena šećerna bolest ili pogoršanje već postojeće šećerne bolesti, liječnik treba pratiti znakove koji upućuju na visoki šećer u krvi.
English: The pharmacokinetics of paliperidone following INVEGA administration are dose proportional within the available dose range.
Croatian: Farmakokinetika paliperidona slijedom uzimanja lijeka INVEGA proporcionalna je dozi unutar dostupnog raspona doza.
English: In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone's known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms.
Croatian: Općenito, očekivani znakovi i simptomi su oni koji proizlaze iz prekomjerno izraženih poznatih farmakoloških učinaka paliperidona, tj. pospanost i sedacija, tahikardija i hipotenzija, produljenje QT
English: • tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body).
Croatian: • tardivna diskinezija (trzajni pokreti lica, jezika i drugih dijelova tijela koje ne možete kontrolirati).
English: Patients treated with any atypical antipsychotic, including INVEGA, should be monitored for symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus should be monitored regularly for worsening of glucose control.
Croatian: Bolesnike koji se liječe bilo kojim atipičnim antipsihotikom, uključujući INVEGU, treba pratiti zbog simptoma hiperglikemije (kao što su polidipsija, poliurija, polifagija i slabost), a bolesnike s dijabetes melitusom treba redovito pratiti zbog mogućeg pogoršanja kontrole glukoze.
English: Taking the results of both studies together (pooled study-data), INVEGA improved the psychotic and manic symptoms of schizoaffective disorder at endpoint relative to placebo when administered either as monotherapy or in combination with mood stabilisers and/or antidepressants.
Croatian: Ako se uzmu u obzir rezultati oba ispitivanja (udruženi podaci ispitivanja), INVEGA je poboljšala psihotične i manične simptome shizoafektivnog poremećaja na kraju ispitivanja u odnosu na placebo kada je primijenjena bilo kao monoterapija ili u kombinaciji sa stabilizatorima raspoloženja i/ili antidepresivima.
English: In a meta-analysis of 17 controlled clinical trials, elderly patients with dementia treated with other atypical antipsychotics, including risperidone, aripiprazole, olanzapine, and quetiapine had an increased risk of mortality compared to placebo.
Croatian: Metaanaliza 17 kontroliranih kliničkih ispitivanja pokazala je da stariji bolesnici s demencijom koji se liječe atipičnim antipsihoticima, uključujući risperidon, aripiprazol, olanzapin i kvetiapin, imaju povećani rizik od smrtnosti u odnosu na placebo.
English: The dose may be increased or decreased by your doctor within the dose range of 3 mg to 12 mg once a day for schizophrenia or 6 mg to 12 mg once a day for schizoaffective disorder.
Croatian: Liječnik može povećati ili smanjiti dozu u rasponu doza od 3 mg do 12 mg jednom dnevno za shizofreniju ili 6 mg do 12 mg jedanput dnevno za shizoafektivni poremećaj.
English: INVEGA High Dose 6 or 12 mg** N=47
Croatian: INVEGA Visoka doza 6 ili 12 mg** N=47
English: Based on in vitro studies utilising human liver enzymes, paliperidone is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of paliperidone.
Croatian: Temeljem in vitro ispitivanja u kojima su korišteni enzimi ljudske jetre, paliperidon nije supstrat za CYP1A2; pušenje, stoga, ne bi trebalo utjecati na farmakokinetiku paliperidona.
English: Refer to ‘Hyperprolactinaemia' below.
Croatian: Vidjeti odjeljak „Hiperprolaktinemija” niže.
English: Menstrual disorder includes: menstruation irregular, oligomenorrhoea
Croatian: Menstrualni poremećaj uključuje: neredovite menstruacije, oligomenoreju
English: White high-density polyethylene (HDPE) bottle with induction sealing and polypropylene child-resistant closure.
Croatian: Bijela boca od polietilena visoke gustoće (HDPE) zatvorena zalijepljenom zaštitnom folijom i polipropilenskim sigurnosnim zatvaračem za djecu.
English: INVEGA with alcohol Alcohol should be avoided when taking this medicine.
Croatian: INVEGA s akoholom Za vrijeme uzimanja ovog lijeka potrebno je izbjegavati alkohol.
English: • breakdown of muscle fibers and pain in muscles (rhabdomyolysis), abnormal posture
Croatian: • pucanje mišićnih vlakana i bol u mišićima (rabdomioliza), nenormalno držanje
English: CARTON FOR PVC-PCTFE/ALUMINIUM BLISTER (for white and clear blister)
Croatian: KUTIJA ZA PVC-PCTFE/ALUMINIJ BLISTER (za bijeli i prozirni blister)
English: • swollen tongue, stomach or intestinal infection, difficulty swallowing, excessive passing of gas or wind
Croatian: • otečen jezik, infekcija želuca ili crijeva, poteškoće s gutanjem, prekomjerno izlaženje zraka ili vjetrovi
English: INVEGA may cause you to gain weight.
Croatian: INVEGA može uzrokovati povećanje težine.
English: Dosage reduction for this medicine should be considered when this medicine is co-administered with valproate.
Croatian: Potrebno je razmotriti smanjenje doze ovog lijeka kada se ovaj lijek primjenjuje istovremeno s valproatom.
English: • common cold symptoms
Croatian: • uobičajeni simptomi prehlade
English: If you stop INVEGA
Croatian: Ako prestanete uzimati INVEGU
English: In a 7-week juvenile toxicity study in rats administered oral doses of paliperidone up to 2.5 mg/kg/day, corresponding to an exposure approximately equal to the clinical exposure based on AUC, no effects on growth, sexual maturation and reproductive performance were observed.
Croatian: U 7-tjednom ispitivanju toksičnosti u mladunčadi štakora, doze paliperidona primjenjene peroralno do 2,5 mg/kg/dan, koje odgovaraju izloženosti približno jednakoj kliničkoj izloženosti temeljeno na AUC, nisu zapaženi učinci na rast, spolno sazrijevanje i reproduktivnu sposobnost.
English: • missed menstrual periods or other problems with your cycle (females), leakage of milk from the breasts, sexual dysfunction, breast pain, breast discomfort
Croatian: • propuštena menstruacija ili drugi problemi s ciklusom (u žena), curenje mlijeka iz dojki, spolna disfunkcija, bol dojki, nelagoda u dojkama
English: If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne ponosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.
English: Efficacy was also evaluated by calculation of treatment response (defined as decrease in PANSS Total Score ≥ 30% and CGI-C Score ≤ 2) as a secondary endpoint.
Croatian: Djelotvornost je također bila procjenjena izračunom odgovora na terapiju (definirana kao smanjenje u PANSS ukupnom rezultatu ≥ 30% i CGI-C rezultat ≤ 2) kao sekundarna mjera ishoda.
English: INVEGA should be used with caution in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction or ischaemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration and hypovolemia).
Croatian: INVEGA se treba koristiti s oprezom kada su u pitanju bolesnici s poznatim kardiovaskularnim bolestima (npr. srčani zastoj, infarkt ili ishemija miokarda, abnormalnosti provođenja impulsa), cerebrovaskularnim bolestima ili stanjima koja čine bolesnika sklonim hipotenziji (npr. dehidracija i hipovolemija).
English: • diabetes or worsening diabetes, high blood sugar, increased waist size, loss of appetite resulting in malnutrition and low body weight, high blood triglycerides (a fat)
Croatian: • šećerna bolest ili pogoršanje postojeće šećerne bolesti, visok šećer u krvi, povećan opseg struka, gubitak apetita koji za posljedicu ima pothranjenost i nisku tjelesnu težinu, visoki trigliceridi u krvi (masnoća)
English: dry mouth, toothache
Croatian: suha usta, zubobolja
English: Dosage adjustment, if indicated, should occur only after clinical reassessment.
Croatian: Prilagodba doze, ukoliko je indicirana, može biti izvršena samo nakon kliničke procjene.
English: • white blood cell count decreased, decrease in platelets (blood cells that help you stop bleeding), anaemia, decrease in red blood cells
Croatian: • smanjen broj bijelih krvnih stanica, smanjen broj trombocita (krvne stanice koje pomažu pri zaustavljenju krvarenja), anemija, smanjen broj crvenih krvnih stanica
English: Efficacy of INVEGA over a flexible dose range of 3 mg/day to 9 mg/day in adolescent subjects (12 years and older) with schizophrenia (INVEGA N = 112, aripiprazole N = 114) was also evaluated in a randomised, double-blind, active-controlled study that included an 8-week, double-blind acute phase and an 18-week, double-blind maintenance phase.
Croatian: Djelotvornost lijeka INVEGA u fleksibilnom rasponu doza od 3 mg/dan do 9 mg/dan u ispitanika adolescenata (12 godina i starijih) sa shizofrenjom (INVEGA N = 112, aripiprazol N = 114) također je bila procijenjena u randomiziranom, dvostruko slijepom ispitivanju s aktivnom kontrolom koje je uključilo 8-o tjednu, dvostruko slijepu akutnu fazu i 18-o tjednu, dvostruko slijepu fazu održavanja.
English: As INVEGA has not been studied in patients with severe hepatic impairment, caution is recommended in such patients.
Croatian: Obzirom da INVEGA nije ispitana kod bolesnika s teškim oštećenjem jetre, preporučuje se oprez kod takvih bolesnika.
English: Schizoaffective disorder: The safety and efficacy of INVEGA in the treatment of schizoaffective disorder in patients aged 12 to 17 years has not been studied or established.
Croatian: Shizoafektivni poremećaj: Sigurnost i djelotvornost lijeka INVEGA u liječenju shizoafektivnog poremećaja u bolesnika dobi 12 do 17 godina nije ispitivano ili ustanovljeno.
English: Schizoaffective disorder (adults)
Croatian: Shizoafektivni poremećaj (odrasli)
English: Very common: may affect more than 1 in 10 people
Croatian: Vrlo često: mogu utjecati na više od 1 na 10 osoba
English: • chills, an increase in body temperature
Croatian: • zimica, povišenje tjelesne temperature
English: During post-marketing surveillance priapism has also been reported with paliperidone, which is the active metabolite of risperidone.
Croatian: Tijekom postmarketinškog praćenja prijapizam je također zabilježen pri peroralnoj primjeni paliperidona, koji je aktivni metabolit risperidona.
English: Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, and behaviour and emotional flatness.
Croatian: Shizofrenija je poremećaj sa simptomima kao što su priviđanje glasova, predmeta ili osjeta koji nisu stvarni, neumjesna/pogrešna uvjerenja, neuobičajena sumnjičavost, povlačenje u sebe, nesuvisao govor i ponašanje, te emocionalna ravnodušnost.
English: - Patients with schizoaffective disorder treated with this medicine should be carefully monitored for a potential switch from manic to depressive symptoms.
Croatian: - Bolesnici sa shizoafektivnim poremećajem koji se liječe ovim lijekom trebaju se pažljivo nadzirati zbog potencijalnih izmjena s maničnih na depresivne simptome.
English: In vitro studies have shown that paliperidone is a P-gp substrate and a weak inhibitor of P-gp at high concentrations.
Croatian: In vitro ispitivanja pokazala su kako je paliperidon P-gp supstrat i slabi inhibitor P-gp-a u visokim koncentracijama.
English: Both studies included subjects who received INVEGA either as monotherapy or in combination with mood stabilisers and/or antidepressants.
Croatian: Oba ispitivanja su uključivala ispitanike koji su lijek INVEGA primili bilo kao monoterapiju bilo u kombinaciji sa stabilizatorima raspoloženja i/ili antidepresivima.
English: The efficacy of INVEGA in the treatment of schizophrenia was established in three multi-centre, placebo-controlled, double-blind, 6-week trials in subjects who met DSM-IV criteria for schizophrenia.
Croatian: Djelotvornost INVEGE u liječenju shizofrenije utvrđena je u tri multicentrična, placebo-kontrolirana, dvostruko slijepa ispitivanja u trajanju od 6 tjedana na ispitanicima koji su ispunjavali kriterij DSM-IV za shizofreniju.
English: Neuroleptic Malignant Syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness, and elevated serum creatine phosphokinase levels has been reported to occur with paliperidone.
Croatian: Maligni neuroleptički sindrom (MNS) karakteriziran hipertermijom, rigiditetom mišića, autonomnom nestabilnošću, promjenom stanja svijesti i povišenim vrijednostima serumske kreatin fosfokinaze, zabilježen je pri uzimanju paliperidona.
English: INVEGA is also used to treat schizoaffective disorder in adults.
Croatian: INVEGA se također koristi za liječenje shizoafektivnog poremećaja u odraslih.
English: Do not use this medicine after the expiry date which is stated on the blister/bottle and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru/boci i kutiji iza oznake „Rok valjanosti”.
English: The mean terminal elimination half-life of paliperidone was 24, 40, and 51 hours in subjects with mild, moderate, and severe renal impairment, respectively, compared with 23 hours in subjects with normal renal function (CrCl ≥ 80 mL/min).
Croatian: Prosječan poluvijek uklanjanja paliperidona je bio 24, 40 i 51 sat kod ispitanika s blagim, umjerenim i ozbiljnim oštećenjem bubrega u usporedbi s 23 sata kod ispitanika s normalnom bubrežnom funkcijom (CrCl ≥ 80 ml/min).
English: INVEGA Low Dose 1.5 mg N=54
Croatian: Niska doza 1,5 mg N=54
English: INVEGA is not for use in children and adolescents who are under 18 years for the treatment of schizoaffective disorder.
Croatian: INVEGA nije namijenjena za primjenu u djece i adolescenata mlađih od 18 godina za liječenje shizoafektivnog poremećaja.
English: In oral carcinogenicity studies of risperidone in rats and mice, increases in pituitary gland adenomas (mouse), endocrine pancreas adenomas (rat), and mammary gland adenomas (both species) were seen.
Croatian: U ispitivanjima kancerogenosti nakon peroralne primjene risperidona na štakorima i miševima uočena su povećanja adenoma hipofize (miševi), adenoma gušterače (štakor) i adenoma mliječnih žlijezda (obiju vrsta).
English: In a 40-week juvenile toxicity study in dogs with oral doses of risperidone (which is extensively converted to paliperidone) up to 5 mg/kg/day, effects on sexual maturation, long bone growth and femur mineral density were observed from 3 times the clinical exposure based on AUC.
Croatian: U 40- tjednom ispitivanju toksičnosti u mladunčadi pasa s peroralnim dozama risperidona (koji se ekstenzivno pretvara u paliperidon) do 5 mg/kg/dan, učinci na spolno sazrijevanje, rast dugih kostiju i mineralnu gustoću femura bili su zapaženi u vidu 3 puta kliničke izloženosti temeljno na AUC.