natgillin/translations-raw huggingface dataset:
• irregular heartbeat, abnormal electrical tracing of the heart (electrocardiogram or ECG), a fluttering or pounding feeling in your chest (palpitations)
• nepravilno bitje srca, nepravilnosti v spremljanju električne aktivnosti srca(elektrokardiogram ali EKG), občutek trepetanja in razbijanja v prsih (palpitacije)
The efficacy of INVEGA in the acute treatment of psychotic or manic symptoms of schizoaffective disorder was established in two placebo-controlled, 6-week trials in non-elderly adult subjects.
Učinkovitost zdravila INVEGA pri akutnem zdravljenju psihotičnih ali maničnih simptomov shizoafektivne motnje so ugotavljali v dveh s placebom nadzorovanih 6-tedenskih preskušanjih pri odraslih preiskovancih, ki niso bili starostniki.
Extrapyramidal symptoms (EPS)
Ekstrapiramidni simptomi (EPS).
The apparent volume of distribution is 487 L. The plasma protein binding of paliperidone is 74%.
Njegov navidezni porazdelitveni volumen je 487 l. Na plazemske beljakovine se veže v 74%, in sicer predvsem na α1-kisli glikoprotein in na albumin.
In vitro studies indicate that paliperidone is not an inducer of CYP1A2 activity.
Študije in vitro kažejo, da paliperidon ne inducira aktivnosti encima CYP1A2.
The amount you take depends on how well the medicine works for you.
Odvisen je od tega, kako dobro bo zdravilo pri vas delovalo.
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.
Pri študijah peroralne kancerogenosti z risperidonom pri podganah in miših so opazili povečanje pogostnosti adenomov žleze hipofize (pri miših), adenomov endokrinega dela trebušne slinavke (pri podganah) in adenomov mlečne žleze (pri obeh vrstah).
INVEGA Medium Dose 3 or 6 mg* N=48
INVEGA srednji odmerek 3 ali 6 mg* N=48
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.
V 40-tedenski študiji toksičnosti pri mladih psih, ki so prejemali do največ 5 mg/kg/dan risperidona peroralno (ki se obsežno pretvori v paliperidon) so opazili učinke na spolno dozorevanje, rast dolgih kosti in mineralno gostoto stegnenice, ki so bili 3krat večji od klinične izpostavljenosti na osnovi AUC.
• lack of emotion
• motnje čustvovanja
INVEGA should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Zdravilo INVEGA je treba uporabljati previdno pri bolnikih z epileptičnimi napadi v pretekli anamnezi ali z drugimi stanji, ki lahko znižajo prag za epileptični napad.
The experience from risperidone is considered valid also for paliperidone.
Izkušnje z risperidonom veljajo tudi za paliperidon.
Conversely, on discontinuation of carbamazepine, the dose of INVEGA should be re-evaluated and decreased if necessary.
Pri ukinjanju karbamazepina je prav tako potrebno ponovno oceniti odmerek zdravila INVEGA in ga po potrebi znižati.
INVEGA should be used with caution in elderly patients with dementia with risk factors for stroke (see section 4.4).
Zdravilo INVEGA uporabljajte previdno pri starejših bolnikih z demenco in z dejavniki tveganja za možgansko kap (glejte poglavje 4.4).
Potential for gastrointestinal obstruction
Možnost obstrukcije prebavil
As INVEGA has not been studied in patients with creatinine clearance below 10 mL/min, use is not recommended in such patients.
Ker zdravila INVEGA niso proučevali pri bolnikih z očistkom kreatinina pod 10 ml/min, pri njih ne priporočamo njegove uporabe.
INVEGA Higher Dose (9-12 mg)
INVEGA večji odmerek (9-12 mg)
Based on pooled data from the three, placebo-controlled, 6-week, fixed-dose trials with INVEGA (3, 6, 9, and 12 mg), orthostatic hypotension was reported by 2.5% of subjects treated with INVEGA compared with 0.8% of subjects treated with placebo.
Po zbranih podatkih iz treh s placebom kontroliranih 6-tedenskih preskušanj s stalnimi odmerki zdravila INVEGA (3, 6, 9 in 12 mg) je ortostatsko hipotenzijo prijavilo 2,5% preiskovancev, zdravljenih z zdravilom INVEGA, v primerjavi z 0,8% preiskovancev, zdravljenih s placebom.
An approximately 3-fold increased risk of cerebrovascular adverse reactions have been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics, including risperidone, aripiprazole, and olanzapine.
V randomiziranih, s placebom kontroliranih kliničnih preskušanjih so pri skupini bolnikov z demenco ugotovili približno za 3-krat povečano tveganje za možganskožilne neželene učinke pri nekaterih atipičnih antipsihotikih, vključno z risperidonom, aripiprazolom in olanzapinom.
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 znižanje količine učinkovine, ki se izloči nespremenjena z urinom kaže na to, da ima sočasno jemanje s karbamazepinom majhen učinek na metabolizem preko CYP ali biološko uporabnost paliperidona.
The efficacy of INVEGA in adolescent subjects with schizophrenia (INVEGA N = 149, placebo N = 51) was studied in a randomised, double-blind, placebo-controlled, 6-week study using a fixed-dose weight-based treatment group design over the dose range of 1.5 mg/day to 12 mg/day.
Učinkovitost zdravila INVEGA pri mladostnikih s shizofrenijo (zdravilo INVEGA N = 149, placebo N = 51) so preučevali v randomizirani, dvojno slepi, s placebom nadzorovani, 6-tedenski študiji z odmerkom določenim glede na telesno maso, v razponu od 1,5 mg/dan do 12 mg/dan.
Eye problems during cataract surgery may also occur.
Med operacijo sive mrene se lahko pojavijo tudi težave z očmi.
Concomitant use of INVEGA with psychostimulants 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).
Sočasna uporaba zdravila INVEGA in psihostimulansov Kombinirana uporaba psihostimulansov (metilfenidata) in paliperidona lahko, ob spremembi enega ali obeh zdravil, povzroči ekstrapiramidne simptome (glejte poglavje 4.4).
eye rolling c, lacrimation increased, ocular hyperaemia
obračanje oči c, povečano solzenje, očesna hiperemija
INVEGA High Dose 6 or 12 mg** N=47
INVEGA velik odmerek 6 ali 12 mg** N=47
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.
Pri novorojenčkih mater, ki so v zadnjih treh mesecih nosečnosti uporabljale zdravilo INVEGA, se lahko pojavijo naslednji simptomi: tresenje, okornost in/ali šibkost mišic, zaspanost, nemir, težave z dihanjem ali motnje hranjenja.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
As INVEGA has not been studied in patients with severe hepatic impairment, caution is recommended in such patients.
Ker zdravila INVEGA niso proučevali pri bolnikih s hudo jetrno okvaro, priporočamo pri njih previdnost.
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.
Shizofrenija je motnja s simptomi, kot so prisluhi, prividi in občutki, ki niso resnični, pa tudi zmotna prepričanja, neobičajna sumničavost, zapiranje vase, nepovezan, zmeden govor in vedenje ter čustvena plitvost.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Vsebnost laktoze(nanaša se samo na 3 mg tablete) Bolniki z redkimi dednimi motnjami galaktozne intolerance, pomanjkanja Lapp laktaze ali malabsorpcije glukoze in galaktoze ne smejo prejemati tega zdravila.
Keep the bottle tightly closed in order to protect from moisture.
Plastenka naj bo tesno zaprta za zagotovitev zaščite pred vlago.
The 3 mg tablet of this medicine contains lactose, a type of sugar.
3 mg tablete zdravila INVEGA vsebujejo laktozo 3 mg tablete tega zdravila vsebujejo laktozo, vrsto sladkorja.
Population pharmacokinetics analyses indicated no discernible difference on the apparent clearance of paliperidone after administration of INVEGA between extensive metabolisers and poor metabolisers of CYP2D6 substrates.
Analize populacijske farmakokinetike niso pokazale nikakršnih vidnih razlik v navideznem očistku paliperidona po jemanju zdravila INVEGA med osebami z obsežno presnovo substratov CYP2D6 in tistimi, ki te substrate slabo presnavljajo.
INVEGA is also used to treat schizoaffective disorder in adults.
Zdravilo INVEGA se uporablja tudi za zdravljenje shizoafektivne motnje pri odraslih.
• dangerously excessive intake of water, low blood sugar, excessive drinking of water, increased cholesterol in your blood
• nevarno prekomerno pitje vode, nizka koncentracija glukoze v krvi, prekomerno pitje vode,
Co-administration of INVEGA with divalproex sodium prolonged-release tablets increased the exposure to paliperidone (see below).
Pri sočasni uporabi zdravila INVEGA in tablet divalproeksa s podaljšanim sproščanjem se poveča izpostavljenost paliperidonu (glejte spodaj).
There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of medicines in non-deformable controlled-release formulations.
Pri bolnikih z znano strikturo v prebavilih so namreč v redkih primerih poročali o obstruktivnih simptomih v povezavi z zaužitjem zdravil v formulacijah z nadzorovanim sproščanjem, ki se ne morejo deformirati.
In the short-term, placebo-controlled, fixed-dose adolescent study, a higher percentage of INVEGA-treated subjects (6-19% depending on dose) had an increase in body weight of ≥ 7% compared to placebo-treated subjects (2%).
V kratkotrajni, s placebom nadzorovani študiji z določenim odmerkom pri mladostnikih, je imel večji odstotek bolnikov, zdravljenih z zdravilom INVEGA (6-19%, odvisno od odmerka) za ≥ 7% povečano telesno maso v primerjavi z bolniki, ki so prejemali placebo (2%).
• glaucoma (increased pressure within the eyeball), increased tears, redness of the eyes, problems with movement of your eyes, eye rolling
• glavkom (zvečan tlak v notranjosti očesa), zvečano solzenje, rdeče oči, težave pri premikanju oči, zavijanje z očmi
Hyperglycemia and diabetes mellitus
Hiperglikemija in sladkorna bolezen
INVEGA may cause you to gain weight.
Zdravilo INVEGA lahko povzroči, da se zredite.
In the study that examined two dose groups (see section 5.1), the increase in body weight of ≥ 7% was 3% in the lower-dose (3-6 mg) group, 7% in the higher-dose (9-12 mg) group, and 1% in the placebo group.
V študiji, v kateri so raziskovali dve skupini, ki sta prejemali različna odmerka (glejte poglavje 5.1), je bilo povečanje telesne mase za ≥ 7% v skupini z manjšim odmerkom (od 3 do 6 mg) 3-odstotno, v skupini z večjim odmerkom (od 9 do 12 mg) 7-odstotno, v skupini, v kateri so preiskovanci prejemali placebo pa 1-odstotno.
Pack sizes of 30 and 350 prolonged-release tablets.
Velikosti pakiranj: 30 in 350 tablet s podaljšanim sproščanjem.
The use of oral risperidone together with this medicine is not recommended as the combination of the two medicines may lead to increased side effects.
Sočasna uporaba peroralnega risperidona in tega zdravila ni priporočljiva, ker lahko ta kombinacija zdravil zveča pojav neželenih učinkov.
• chills, an increase in body temperature
• mrzlica, zvišanje telesne temperature,
Paliperidone is the active metabolite of risperidone.
Paliperidon je aktivni presnovek risperidona.
In schizophrenia clinical trials, there was no difference observed between placebo and the 3 and 6 mg doses of INVEGA.
V kliničnih preskušanjih shizofrenije niso opazili razlike med placebom in 3 mg in 6 mg odmerki zdravila INVEGA.
For patients with moderate to severe renal impairment (creatinine clearance  10 to < 50 mL/min), the recommended initial dose of INVEGA is 3 mg every other day, which may be increased to 3 mg once daily after clinical reassessment.
Pri bolnikih z zmerno do hudo okvaro ledvic (očistek kreatinina  10 do < 50 ml/min) je priporočeni začetni odmerek zdravila INVEGA 3mg vsak drug dan. Odmerek se lahko poveča na 3 mg enkrat na dan po ponovni klinični oceni bolnikovega stanja.
INVEGA Lower Dose (3-6 mg)
INVEGA manjši odmerek (3-6 mg)
• high blood triglycerides (a fat)
• visoke koncentracije trigliceridov v krvi (maščobe)
Responder, n (%) Non-responder, n (%) P value (vs Placebo)
Preiskovanci, ki se odzivajo, n (%) Preiskovanci, ki se ne odzivajo, n (%) Vrednost p (v primerjavi s placebom)
Paliperidone may antagonise the effect of levodopa and other dopamine agonists.
Paliperidon ima lahko antagonistično delovanje na levodopo in druge agoniste dopamina.
• symptoms of drug withdrawal.
• sindrom odtegnitve zdravila
• weight gain, increased appetite, weight loss, decreased appetite
• povečanje telesne mase, povečan apetit, zmanjšanje telesne mase, zmanjšan apetit
Patients with schizoaffective disorder treated with paliperidone should be carefully monitored for a potential switch from manic to depressive symptoms.
Bolnike s shizoafektivno motnjo, ki prejemajo paliperidon, je treba skrbno spremljati, ker pri njih lahko pride do prehoda iz maničnih v depresivne simptome.
neutropenia, eosinophil count increased
nevtropenija, povečanje števila eozinofilcev
In case of severe extrapyramidal symptoms, anticholinergic agents should be administered.
V primeru močnih ekstrapiramidnih simptomov dajte bolniku antiholinergik.
Co-administration of INVEGA once daily with carbamazepine 200 mg twice daily caused a decrease of approximately 37% in the mean steady-state Cmax and AUC of paliperidone.
Sočasno jemanje zdravila INVEGA, enkrat na dan in 200 mg karbamazepina, dvakrat na dan, povzroči približno 37 % znižanje povprečnega ravnotežnega stanja Cmax in AUC paliperidona.
30 prolonged-release tablets 350 prolonged-release tablets
30 tablet s podaljšanim sproščanjem 350 tablet s podaljšanim sproščanjem
Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicinal products.
Antipsihotikom pripisujejo motnje v sposobnosti telesa, da zmanjša temperaturo jedra.
Pharmacologic group: Psycholeptics, other antipsychotics ATC code: N05AX13
Oznaka ATC: N05AX13
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.
Pri predpisovanju zdravila INVEGA bolnikom, ki se bodo lahko znašli v okoliščinah, ko se zviša temperatura jedra, npr. naporna telesna vadba, izpostavljenost skrajni toploti, sočasno prejemanje zdravil z antiholinergičnim delovanjem ali dehidracija, svetujemo ustrezno previdnost.
Safety and efficacy of INVEGA in patients > 65 years of age with schizoaffective disorder have not been studied.
Varnosti in učinkovitosti zdravila INVEGA pri bolnikih s shizoafektivno motnjo, starih > 65 let, niso ugotavljali.
It must be swallowed whole with liquid, and must not be chewed, divided, or crushed.
Tableto naj bolnik pogoltne celo s tekočino in je ne sme žvečiti, razdeliti ali zdrobiti.
You may experience sleepiness, tiredness, abnormal body movements, problems with standing and walking, dizziness from low blood pressure, and abnormal heart beats.
Morda boste postali zaspani ali utrujeni, lahko pa se pojavijo tudi nenormalni telesni gibi, težave pri stanju in hoji, omotica zaradi nizkega krvnega tlaka in nenormalno bitje srca.
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs - Frequency unknown.
Pri uporabi antipsihotikov so poročali o primerih venskega trombembolizma, vključno s pljučno embolijo in globoko vensko trombozo (pogostnost ni znana).
INVEGA should be used with caution in elderly patients with dementia who have risk factors for stroke.
Zdravilo INVEGA uporabljajte previdno pri starejših bolnikih z demenco in dejavniki tveganja za možgansko kap.
Caution is advised when prescribing INVEGA with medicines 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 other antipsychotics and some antimalarials (e.g., mefloquine).
Pri sočasnem predpisovanju zdravila INVEGA z zdravili, ki podaljšajo interval QT, npr. antiaritmiki razreda IA (npr. kinidin, dizopiramid) in antiaritmiki razreda III (npr. amiodaron, sotalol), nekaterimi antihistaminiki, nekaterimi antipsihotiki in nekaterimi zdravili proti malariji (npr. meflokin) svetujemo previdnost.
In addition to the above adverse reactions, the following adverse reactions have been noted with the use of risperdone products and can be expected to occur with INVEGA.
Dodatno k zgoraj navedenim neželenim učinkom, so naslednje neželene učinke poročali pri uporabi risperidona, zato se lahko pojavijo tudi pri uporabi zdravila INVEGA.
• pneumonia caused by inhaling food, congestion of breathing passages, voice disorder
• pljučnica, povzročena z vdihnjeno hrano, zapora dihalnih poti, motnje glasu
• missed menstrual periods or other problems with your cycle (females), leakage of milk from the breasts, sexual dysfunction, breast pain, breast discomfort
• izostanek menstruacije ali druge motnje menstrualnega cikla pri ženskah, iztekanje mleka iz dojk, spolna disfunkcija, bolečina v dojkah, nelagodje v dojkah
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).
Shizoafektivna motnja je duševna bolezen, pri kateri se poleg simptomov motnje razpoloženja (zelo privzdignjeno razpoloženje, žalost, razdražljivost, raztresenost, nespečnost, zgovornost, izguba zanimanja za vsakdanje dejavnosti, preveč ali premalo spanja, zaužitje preveč ali premalo hrane in ponavljajoče se samomorilne misli), pri oboleli osebi pojavi kombinacija simptomov shizofrenije (navedenih zgoraj).
Endocrine disorders hyperprolactinaemia inappropriate antidiuretic hormone secretion c, glucose urine present
Bolezni endokrinega sistema hiperprolaktinemija a motnje v izločanju antidiuretičnega hormona c, prisotnost glukoze v urinu
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).
Srednja končna razpolovna doba izločanja paliperidona je znašala 24 ur pri preiskovancih z blago okvaro ledvic, 40 ur pri preiskovancih z zmerno okvaro ledvic in 51 ur pri tistih s hudo okvaro ledvic, v primerjavi s 23 urami pri preiskovancih z normalnim delovanjem ledvic (CrCl ≥ 80 ml/min).
• convulsion (fits), 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
• konvulzije (napadi krčev), omedlevica, nuja premikati dele telesa, omotica ob vstajanju, motnje pozornosti, težave pri govoru, izguba normalnega zaznavanja okusa, zmanjšana občutljivost kože na bolečino in dotik, občutek mravljinčenja, zbadanja in odrevenelosti kože,
Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with INVEGA and preventive measures undertaken.
Zato je pred in med zdravljenjem z zdravilom INVEGA treba preveriti vse dejavnike tveganja za VTE in uvesti preventivne ukrepe.
In the short-term, placebo-controlled, fixed-dose adolescent study, the incidence of EPS was higher than placebo for all doses of INVEGA with an increased frequency of EPS at higher doses.
V kratkotrajni, s placebom nadzorovani študiji z določenim odmerkom pri mladostnikih, je bila incidenca EPS pri vseh skupinah, ki so prejemale zdravilo INVEGA večja kot pri placebu, s povečano pogostnostjo pri večjih odmerkih.
Adverse reactions that may suggest increase in prolactin levels (e.g., amenorrhoea, galactorrhoea, menstrual disturbances, gynaecomastia) were reported overall in 9.3% of subjects.
O neželenih učinkih, ki bi lahko bili povezani s prolaktinom (npr. o amenoreji, galaktoreji, menstrualnih motnjah, ginekomastiji) pa so poročali pri skupaj 9,3% preiskovancev.
The other ingredients are:
Vsebniki:
The effects of this medicine may be affected if you are taking medicines that affect the speed of movement in the gut (e.g., metoclopramide).
Na učinkovitost tega zdravila lahko vpliva tudi jemanje zdravil, ki vplivajo na hitrost gibanja črevesja (kot je metoklopramid) .
The recommended dose in adults is 6 mg once a day taken in the morning.
Priporočeni odmerek pri odraslih je 6 mg enkrat na dan, zjutraj.
• severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure, allergic reaction
• resne alergijske reakcije za katere so značilni vročina, otekla ustna sluznica, obraz, ustnice ali jezik, težko dihanje, srbenje, kožni izpuščaj in včasih tudi znižanje krvnega tlaka, alergijska reakcija
In a long-term trial designed to assess the maintenance of effect, INVEGA was significantly more effective than placebo in maintaining symptom control and delaying relapse of schizophrenia.
V dolgotrajnem preskušanju za oceno ohranitve učinka zdravila INVEGA je bilo to zdravilo bistveno bolj učinkovito od placeba pri ohranjanju nadzora nad simptomi in pri zapoznitvi ponovnih izbruhov shizofrenije.
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.
Skupen obseg učinka, glede na oceno PANSS ali YMRS, ki so ga opazili pri samostojnem zdravljenju, je bil večji kot učinek, ki so ga opazili pri sočasni uporabi z antidepresivi in/ali stabilizatorji razpoloženja.
Do not use this medicine after the expiry date which is stated on the blister/bottle and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu oz. plastenki in škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Paliperidone is rapidly distributed.
Paliperidon se hitro porazdeli po telesu.
Co-administration of a single dose of INVEGA 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.
Sočasna uporaba enkratnega 12 mg odmerka zdravila INVEGA in tablet divalproeksa s podaljšanim sproščanjem (dve 500 mg tableti enkrat na dan) je za približno 50% povečala vrednosti Cmax in AUC paliperidona.
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.
Pri mladostnikih s telesno maso < 51 kg so opažali za 23% večjo izpostavljenost kot pri mladostnikih s telesno maso ≥ 51 kg.
9/L) should discontinue INVEGA and have their WBC followed until recovery.
9/l) je potrebno zdravljenje z zdravilom INVEGA ukiniti in spremljati število levkocitov do normalizacije.