natgillin/translations-raw huggingface dataset:
Other medicines that have this effect include some medicines used to treat the rhythm of the heart or to treat infection, and other antipsychotics.
Med druga zdravila s takim učinkom sodijo nekatera zdravila za zdravljenje srčnega ritma, nekatera zdravila za zdravljenje okužb in drugi antipsihotiki.
During the 33-week open-label transition/maintenance period of the long-term recurrence prevention trial, 12% of Xeplion-treated subjects met this criterion (weight gain of ≥ 7% from double-blind phase to endpoint); the mean (SD) weight change from open-label baseline was + 0.7 (4.79) kg.
Med 33-tedenskim odprtim prehodnim/vzdrževalnim obdobjem preskušanja dolgotrajnega preprečevanja ponovitve bolezni je to merilo doseglo 12% preiskovancev, ki so jih zdravili z zdravilom Xeplion (povečanje telesne mase za  7% od dvojno slepe faze do zaključka); povprečna sprememba telesne mase (standardni odklon) od začetka odprte faze je bila +0,7 (4,79) kg.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJE
Concomitant administration of oral paliperidone with paroxetine, a potent CYP2D6 inhibitor, showed no clinically significant effect on the pharmacokinetics of paliperidone.
Pri sočasni uporabi peroralnega paliperidona in paroksetina, močnega zaviralca encima CYP2D6, ni bilo klinično pomembnih učinkov na farmakokinetiko paliperidona.
The recommended needle size for initial and maintenance administration of Xeplion into the deltoid muscle is determined by the patient's weight.
Priporočeno velikost igle za uvajalno in vzdrževalno injiciranje zdravila Xeplion v deltoidno mišico določimo glede na bolnikovo telesno maso.
It should be injected slowly, deep into the deltoid or gluteal muscle.
Injicirati ga je treba počasi, globoko v deltoidno ali glutealno mišico.
Due to its extremely low water solubility, paliperidone palmitate dissolves slowly after intramuscular injection before being hydrolysed to paliperidone and absorbed into the systemic circulation.
Zaradi izjemno majhne topnosti v vodi se po intramuskularnem injiciranju paliperidonijev palmitat počasi raztaplja, nato pride do hidrolize v paliperidon in absorpcije v sistemski krvi obtok.
• a reaction at the injection site, including itching, pain or swelling.
• reakcija ne mestu injiciranja, vključno s srbenjem, bolečino ali otekanjem
Immune system disorders hypersensitivity anaphylactic reaction
Bolezni imunskega sistema preobčutljivost anafilaktična reakcija
Paliperidone may antagonise the effect of levodopa and other dopamine agonists.
Paliperidon ima lahko antagonističen učinek na levodopo in druge agoniste dopamina.
• experience involuntary rhythmic movements of the tongue, mouth and face.
• imate nehotene ritmične gibe jezika, ust in obraza.
To avoid a missed dose, patients may be given the second dose 4 days before or after the one-week (day 8) time point.
Da preprečite spuščanje odmerka, lahko bolnikom drugi odmerek injicirate tudi 4 dni pred tedenskim časovnim rokom (8. dan) ali 4 dni po njem.
Missed monthly maintenance dose (> 6 weeks to 6 months) If more than 6 weeks have elapsed since the last injection of Xeplion, the recommendation is as follows:
Spuščen mesečni vzdrževalni odmerek (> 6 tednov do 6 mesecev) Če je od zadnjega injiciranja zdravila Xeplion preteklo več kot 6 tednov, priporočamo:
It is recommended that the second initiation dose of Xeplion be given one week after the first dose.
Priporočeno je, da se drugi uvajalni odmerek zdravila Xeplion injicira en teden po prvem odmerku.
The absolute bioavailability of paliperidone palmitate following Xeplion administration is 100%.
Absolutna biološka uporabnost paliperidonijevega palmitata po injiciranju zdravila Xeplion je 100%.
The median apparent half-life of paliperidone following Xeplion administration over the dose range of 25-150 mg ranged from 25-49 days.
Mediana vrednost navideznega razpolovnega časa paliperidona po injiciranju zdravila Xeplion v razponu odmerkov od 25 do 150 mg je bila od 25 do 49 dni.
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.
V študijah reprodukcije pri podganah z uporabo peroralnega risperidona, ki se, tako pri podganah kot pri človeku, v velikem obsegu pretvarja v paliperidon, so opazili neželene učinke v smislu zmanjšanje porodne teže in preživetja mladičev.
• blood clot in the lungs causing chest pain and difficulty in breathing.
• krvni strdki v pljučih, ki povzročajo bolečino v prsnem košu in oteženo dihanje.
The trial was stopped early for efficacy reasons as a significantly longer time to relapse (p < 0.0001, Figure 1) was seen in patients treated with Xeplion compared to placebo (hazard ratio = 4.32; 95% CI: 2.4-7.7).
Preskušanje je bilo predčasno prekinjeno zaradi učinkovitosti zdravila, saj so pri bolnikih, ki so se zdravili z zdravilom Xeplion, opazili pomembno daljši čas do relapsa (p < 0,0001, slika 1) kot pri bolnikih, ki so prejemali placebo (razmerje tveganja = 4,32; 95% IZ: 2,4-7,7).
Discard the syringe with needle appropriately.
Brizgo skupaj z iglo ustrezno zavrzite.
Although Xeplion was not studied on patients with hepatic impairment, no dose adjustment is required in patients with mild or moderate hepatic impairment.
Čeprav zdravila Xeplion niso preučevali pri bolnikih z okvaro jeter, pri bolnikih z blago ali zmerno okvaro jeter ni treba prilagajati odmerka.
Following a single intramuscular dose, the plasma concentrations of paliperidone gradually rise to reach maximum plasma concentrations at a median Tmax of 13 days.
Po enkratnem intramuskularnem odmerku se koncentracije paliperidona v plazmi postopoma večajo in pri mediani vrednosti Tmax 13 dni dosežejo največje koncentracije v plazmi.
Hyperglycaemia and diabetes mellitus
Hiperglikemija in sladkorna bolezen
The combined use of psychostimulants (e.g., methylphenidate) with paliperidone can lead to extrapyramidal symptoms upon change of either or both treatments (see section 4.4).
Kombinirana uporaba psihostimulansov (metilfenidata) in paliperidona lahko ob spremembi enega ali obeh zdravil povzroči ekstrapiramidne simptome (glejte poglavje 4.4).
Missed second initiation dose (< 4 weeks from first injection) If less than 4 weeks have elapsed since the first injection, then the patient should be administered the second injection of 100 mg in the deltoid muscle as soon as possible.
Spuščen drugi uvajalni odmerek (< 4 tedne od prvega injiciranja) Če je od prvega injiciranja preteklo manj kot 4 tedne, je treba bolniku čim prej injicirati drugi 100-miligramski odmerek v deltoidno mišico.
In clinical trials, median increases in serum prolactin were observed in subjects of both genders who received Xeplion.
V kliničnih preskušanjih so pri preiskovancih obeh spolov opazili povečanje mediane vrednosti serumskega prolaktina pri zdravljenju z zdravilom Xeplion.
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.
V študijah kancerogenosti peroralnega paliperidona na podganah in miših so opazili povečano pogostnost adenomov hipofize (pri miših), adenomov endokrinega dela trebušne slinavke (pri podganah) in adenomov mlečnih žlez (pri obeh vrstah).
59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised in the liver.
C-paliperidona s takojšnjim sproščanjem, se je 59% odmerka izločilo nespremenjenega z urinom, kar kaže, da se paliperidon v jetrih ne presnavlja v veliki meri.
In case of severe extrapyramidal symptoms, anticholinergic agents should be administered.
Če so ekstrapiramidni simptomi hudi, je treba uporabiti antiholinergik.
Effect of smoking on the pharmacokinetics of paliperidone was not studied with Xeplion.
Vpliv kajenja na farmakokinetiko paliperidona pri uporabi zdravila Xeplion niso preučevali.
Thereafter, you will receive an injection (ranging from 25 mg to 150 mg) in either the upper arm or buttocks once a month.
Nato boste prejeli injekcijo (v odmerkih od 25 mg do 150 mg) v zgornji del roke ali v zadnjico enkrat na mesec.
Pregnancy, puerperium and perinatal conditions drug withdrawal syndrome neonatal (see section 4.6)
Motnje v času nosečnosti, puerperija in perinatalnem obdobju sindrom odtegnitve zdravila pri novorojenčku (glejte poglavje 4.6)
• dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood
• nevarno majhno število določenih vrst belih krvnih celic, ki jih potrebujete za obrambo pred okužbo v krvi
• an increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes released with muscle breakdown
• povečana koncentracija kreatin fosfokinaze (CPK) v krvi (encima, ki se včasih sprosti ob razpadanju mišic)
This medicine can pass from mother to baby through breast milk and may harm the baby.
To zdravilo lahko z materinim mlekom prehaja do dojenčka in mu lahko škoduje, zato ne smete dojiti, če uporabljate to zdravilo.
• high blood triglycerides (a fat), increased cholesterol in your blood
• povišane koncentracije trigliceridov (maščob) v krvi, povišane koncentracije holesterola v krvi
What Xeplion looks like and contents of the pack Xeplion is a white to off-white prolonged release suspension for injection in a pre-filled syringe.
Izgled zdravila Xeplion in vsebina pakiranja Zdravilo Xeplion je bela do sivkastobela suspenzija za injiciranje s podaljšanim sproščanjem v napolnjeni injekcijski brizgi.
Of these, akathisia and sedation/somnolence appeared to be dose-related.
Kaže, da so akatizija in sedacija/somnolenca odvisni od odmerka.
• experience fever, muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”).
• imate visoko telesno temperaturo, okorele mišice, se potite ali imate zmanjšano stopnjo zavesti (stanje, ki se imenuje nevroleptični maligni sindrom).
As paliperidone has not been studied in patients with severe hepatic impairment, caution is recommended in such patients (see section 5.2).
Ker paliperidona niso preučevali pri bolnikih s hudo okvaro jeter, je pri njih potrebna previdnost (glejte poglavje 5.2).
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.
Majhno zmanjšanje količine učinkovine, ki se izloči nespremenjena z urinom kaže, da ima sočasno jemanje s karbamazepinom majhen učinek na metabolizem preko CYP ali biološko uporabnost paliperidona.
The plasma concentrations of paliperidone are increased in patients with renal impairment and therefore, dose adjustment is recommended in patients with mild renal impairment.
Pri bolnikih z okvaro ledvic so koncentracije paliperidona v plazmi povečane, zato pri bolnikih z blago ledvično okvaro priporočamo prilagoditev odmerka.
• common cold symptoms, urinary tract infection, feeling like you have the flu
• simptomi prehlada, okužba sečil, občutek, da imate gripo
Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicinal products.
Antipsihotikom pripisujejo motenje sposobnosti telesa za zniževanje temperature telesnega jedra.
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.
Med jemanjem tega zdravila so pri bolnikih opazili sladkorno bolezen ali njeno poslabšanje, zato bo vaš zdravnik preverjal, če imate znake povečane koncentracije sladkorja v krvi.
Other injection site reactions were mostly mild in intensity and included induration (common), pruritus (uncommon) and nodules (rare).
Ostale reakcije na mestu injiciranja, ki so vključevale induracijo (pogosta), srbenje (občasno) in noduluse (redki), so bile večinoma blage.
If you have shown responsiveness to paliperidone or risperidone in the past and have mild to moderate symptoms your doctor may start treatment with Xeplion without prior stabilisation with paliperidone or risperidone.
Če ste se odzvali na prejšnje zdravljenje s paliperidonom ali risperidonom in imate blage ali zmerne simptome bolezni, vas bo zdravnik lahko začel zdraviti z zdravilom Xeplion brez predhodne stabilizacije s paliperidonom ali risperidonom.
Xeplion has not been systematically studied in patients with renal impairment (see section 5.2).
ZdravilaXeplion niso sistematično preučevali pri bolnikih z okvaro ledvic (glejte poglavje 5.2).
Care must be taken to avoid inadvertent injection of Xeplion into a blood vessel.
Pazimo, da zdravila Xeplion pomotoma ne injiciramo v krvno žilo.
In general, overall initiation plasma levels with Xeplion were within the exposure range observed with 6-12 mg prolonged release oral paliperidone.
Na splošno so bile celokupne plazemske koncentracije zdravila Xeplion ob uvajanju znotraj v razponu izpostavljenosti 6-12 mg peroralnega paliperidona s podaljšanim sproščanjem.
• are aware of having dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood.
• veste, da imate nevarno majhno število določenih tipov belih krvnih celic, ki jih potrebujete za obrambo pred okužbo.
Missed monthly maintenance dose (1 month to 6 weeks) After initiation, the recommended injection cycle of Xeplion is monthly.
Spuščen mesečni vzdrževalni odmerek (od 1 meseca do 6 tednov) Po uvajanju je priporočeno enkrat mesečno injiciranje zdravila Xeplion.
Prolonged release suspension for injection Day 8
suspenzija za injiciranje s podaljšanim sproščanjem za 8. dan
• parkinsonism: This condition may include slow or impaired movement, sensation of stiffness or tightness of the muscles (making your movements jerky), and sometimes even a sensation of movement "freezing up" and then restarting.
• parkinsonizem: to stanje lahko vključuje zmanjšano ali moteno gibanje telesa, občutek togosti ali napetosti mišic (nenavadni sunkoviti gibi), včasih celo občutek, da gibanje zastane in se nato nadaljuje.
The recommended monthly maintenance dose is 50 mg with a range of 25 to 100 mg based on patient tolerability and/or efficacy.
Priporočeni mesečni vzdrževalni odmerek je 50 mg, njegov razpon pa je lahko od 25 do 100 mg, kar je odvisno od bolnikovega prenašanja in/ali učinkovitosti zdravila.
CARDBOARD CARTON (100 mg PRE-FILLED SYRINGE, COMPONENT OF TREATMENT INITIATION PACK - WITHOUT BLUE BOX)
KARTONASTA ŠKATLA (100 mg NAPOLNJENA INJEKCIJSKA BRIZGA, KOMPLET ZA UVEDBO ZDRAVLJENJA - BREZ MODREGA OKENCA)
If you have mild kidney problems your doctor may give you a lower dose.
Če imate blago okvaro ledvic, vam bo zdravnik lahko zmanjšal odmerek zdravila.
This medicine will be given to you under medical supervision; it is, therefore, unlikely that you will be given too much.
Če ste vzeli večji odmerek zdravila Xeplion, kot bi smeli To zdravilo boste prejemali pod zdravniškim nadzorom, zato je malo verjetno, da boste prejeli prevelik odmerek.
Neonates exposed to paliperidone during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Pri novorojenčkih, ki so bili med tretjim trimesečjem nosečnosti izpostavljeni paliperidonu, obstaja tveganje za pojav neželenih učinkov, vključno z ekstrapiramidnimi in/ali odtegnitvenimi simptomi, katerih jakost in čas trajanja po porodu sta lahko različna.
Rare side effects: may affect up to 1 in 1,000 people
Redki: pojavijo se lahko pri največ 1 od 1.000 bolnikov
• newborn babies born to mothers who have taken Xeplion 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
• pri novorojenčkih mater, ki so v nosečnosti prejemale zdravilo Xeplion, se lahko pojavijo neželeni učinki zdravila in/ali odtegnitveni simptomi, kot so razdražljivost, počasni ali dolgotrajni krči mišic, tresenje zaspanost, težave z dihanjem ali motnje hranjenja
• rapid heart rate
• hiter srčni utrip
Injections into the deltoid were perceived as slightly more painful than corresponding gluteal injections.
Injiciranje v deltoidno mišico so bolniki ocenili kot rahlo bolj boleče kot injiciranje v glutealno mišico.
Previous oral paliperidone or oral risperidone can be discontinued at the time of initiation of treatment with Xeplion.
Predhodno zdravljenje s peroralnim paliperidonom ali peroralnim risperidonom lahko prekinemo ob uvedbi zdravljenja z zdravilom Xeplion.
Xeplion is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min) (see sections 4.2 and 5.2).
Uporaba zdravila Xeplion pri bolnikih z zmerno ali hudo ledvično okvaro (očistek kreatinina < 50 ml/min) ni priporočljiva (glejte poglavji 4.2 in 5.2).
Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.
Zdravilo Xeplion je indicirano za vzdrževalno zdravljenje shizofrenije pri odraslih bolnikih, stabiliziranih s paliperidonom ali risperidonom.
Vascular disorders hypertension hypotension, orthostatic hypotension venous thrombosis, flushing pulmonary embolism, ischaemia
Žilne bolezni hipertenzija hipotenzija, ortostatska hipotenzija venska tromboza, rdečica pljučna embolija, ishemija
Switching from risperidone long acting injection to Xeplion When switching patients from risperidone long acting injection, initiate Xeplion therapy in place of the next scheduled injection.
Prehod z dolgodelujoče injekcije risperidona na zdravilo Xeplion Kadar preidemo z dolgodelujoče injekcije risperidona, zdravilo Xeplion bolniku uvedemo ob naslednjem načrtovanem injiciranju.
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.
Med očesno operacijo zaradi zamotnitve očesne leče (katarakta, operacija sive mrene) se lahko zgodi, da se zenica (črni krog v sredini očesa) ne širi kot bi se morala.
If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
Če se pripravljate na operacijo očesa, morate o jemanju tega zdravila obvestiti zdravnika okulista.
Use in patients with prolactin-dependent tumours
Uporaba pri bolnikih s tumorji, odvisnimi od prolaktina
Population pharmacokinetics analyses indicated no discernible difference on the apparent clearance of paliperidone after administration of oral paliperidone between extensive metabolisers and poor metabolisers of CYP2D6 substrates.
Analize populacijske farmakokinetike niso pokazale nobene razlike v navideznem očistku paliperidona po zaužitju peroralnega paliperidona med bolniki s hitro in počasno presnovo substratov encima CYP2D6.
Thereafter, the monthly maintenance injections can be administered in either the DELTOID or GLUTEAL muscle using the appropriate needle for the injection site.
Mesečna vzdrževalna injekcija se lahko injicira v v DELTOIDNO ali v GLUTEALNO mišico in uporabi pravo iglo za mesto injiciranja.
This leaflet was last revised in
To navodilo je bilo nazadnje revidirano dne MM/LLLL
Patients who are overweight or obese may require doses in the upper range (see section 5.2).
Bolniki s prekomerno telesno maso bodo morda potrebovali odmerke v zgornjem delu razpona (glejte poglavje 5.2).
• diabetes or worsening of diabetes, increased insulin (a hormone that controls blood sugar levels)
• sladkorna bolezen ali poslabšanje sladkorne bolezni, povišanje koncentracije insulina (hormon,
Xeplion 25 mg prolonged release suspension for injection Xeplion 50 mg prolonged release suspension for injection Xeplion 75 mg prolonged release suspension for injection Xeplion 100 mg prolonged release suspension for injection Xeplion 150 mg prolonged release suspension for injection
Xeplion 25 mg suspenzija za injiciranje s podaljšanim sproščanjem Xeplion 50 mg suspenzija za injiciranje s podaljšanim sproščanjem Xeplion 75 mg suspenzija za injiciranje s podaljšanim sproščanjem Xeplion 100 mg suspenzija za injiciranje s podaljšanim sproščanjem Xeplion 150 mg suspenzija za injiciranje s podaljšanim sproščanjem
Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% on average in mild (CrCl = 50 to < 80 mL/min), 64% in moderate (CrCl = 30 to < 50 mL/min), and 71% in severe (CrCl = 10 to < 30 mL/min) renal impairment, corresponding to an average increase in exposure (AUCinf) of 1.5, 2.6, and 4.8 fold, respectively, compared to healthy subjects.
Skupni očistek paliperidona se je pri preizkušancih z okvaro ledvic v povprečju zmanjšal za 32% pri blagi (CrCl = 50 do < 80 ml/min), 64% pri zmerni (CrCl = 30 do < 50 ml/min) in 71% pri hudi (CrCl = 10 do < 30 ml/min) ledvični okvari, kar je skladno s povprečnim povečanjem izpostavitve (AUCinf) 1,5-, 2,6- oziroma 4,8-krat v primerjavi z zdravimi preiskovanci.
The plasma protein binding of racemic paliperidone is 74%.
Vezava racemnega paliperidona na plazemske beljakovine je približno 74%.
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.
Med očesno operacijo zaradi zamotnitve očesne leče (katarakta) se lahko zgodi, da šarenica (obarvani del očesa) postane ohlapna (kar imenujemo sindrom ohlapne šarenice) in to lahko povzroči poškodbo očesa.
• chapped lips
• razpokane ustnice
• 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
• omedlevica, neprestana potreba po premikanju delov telesa, omotica pri vstajanju, motnje pozornosti, težave pri govoru, izguba ali nenormalno zaznavanje okusa, zmanjšana občutljivot kože na bolečino in dotik, občutek mravljinčenja, zbadanja in odrevenelosti kože
Missed second initiation dose (> 7 weeks from first injection) If more than 7 weeks have elapsed since the first injection of Xeplion, initiate dosing as described for the initial recommended initiation of Xeplion above.
Spuščen drugi uvajalni odmerek (> 7 tednov od prvega injiciranja) Če je od prvega injiciranja zdravila Xeplion preteklo več kot 7 tednov, odmerjanje začnite tako, kot je opisano za prvo začetno uvajanje zdravila Xeplion.
Following intramuscular injection of single doses (25-150 mg) in the deltoid muscle, on average, a 28% higher Cmax was observed compared with injection in the gluteal muscle.
Po intramuskularnem injiciranju enkratnih odmerkov (25-150 mg) v deltoidno mišico, so v povprečju opazili za 28% večjo vrednost Cmax kot pri injiciranju v glutealno mišico.
If your doctor is switching you from risperidone long acting injection to this medicine, you will receive the first injection of this medicine (ranging from 25 mg to 150 mg) in either the upper arm or buttocks on the date that your next injection was scheduled.
Če vam zdravnik zamenja dolgodelujoče injekcije risperidona s tem zdravilom, boste prejeli prvo injekcijo tega zdravila (v odmerkih od 25 mg do 150 mg) v zgornji del roke ali v zadnjico ob načtovanem naslednjem injiciranju.
Appropriate care is advised when prescribing Xeplion 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.
Pri predpisovanju zdravila Xeplion bolnikom, ki se lahko znajdejo v okoliščinah, ko se poviša temperatura jedra, npr. naporna telesna vadba, izpostavljenost skrajni vročini, sočasno jemanjen zdravil z antiholinergičnim delovanjem ali dehidracija, svetujemo ustrezno oskrbo.
Withdrawal of paliperidone may be needed.
Morda bo potrebno prekiniti zdravljenje s paliperidonom.