natgillin/translations-raw huggingface dataset:
In the open-label phase of the study during 20 weeks cariprazine treatment 9.0% of patients developed potentially clinically significant (PCS) weight gain (defined as increase ≥ 7%) while during the double-blind phase, 9.8 % of the patients who continued with cariprazine treatment had PCS weight gain versus 7.1% of the patients who were randomized to placebo after the 20 week open-label cariprazine treatment.
V odprti fazi študije so med 20 tedni zdravljenja s kariprazinom pri 9,0 % bolnikov poročali o potencialno klinično pomembnem zvečanju telesne mase (opredeljenem kot zvečanje ≥ 7 %), medtem ko so po 20 tednih odprtega zdravljenja s kariprazinom med dvojno slepo fazo zabeležili potencialno klinično pomembno zvečanje telesne mase pri 9,8 % bolnikov, ki so nadaljevali zdravljenje s kariprazinom, v primerjavi s 7,1 % bolnikov, randomiziranih na placebo.
Cariprazine and its major active metabolites did not induce CYP1A2, CYP2B6 and CYP3A4 enzymes and were not inhibitors of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP219, CYP2D6, CYP2E1 and CYP3A4 in vitro.
Kariprazin in njegova glavna aktivna presnovka in vitro niso inducirali encimov CYP1A2, CYP2B6 ter CYP3A4 in niso bili zaviralci CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP219, CYP2D6, CYP2E1 in CYP3A4.
Safety and efficacy of cariprazine have not been evaluated in patients with severe renal impairment (CrCl < 30 mL/min).
Varnost in učinkovitost kariprazina nista bili ocenjeni pri bolnikih s hudo okvaro ledvic (CrCl < 30 ml/min).
The recommended starting dose is 1.5 mg once a day by mouth.
Priporočeni začetni odmerek je 1,5 mg enkrat na dan peroralno.
Change From Baseline to Week 6 in the PANSS Total Score in Studies of Acute Exacerbations of Schizophrenia-ITT Population
Sprememba od izhodišča do 6. tedna v skupni vrednosti PANSS v študijah akutne eksacerbacije shizofrenije pri populaciji ITT Izhodišče povprečje
Absolute bioavailability of cariprazine is unknown.
Absolutna biološka uporabnost kariprazina ni znana.
CYP2D6 mediated pathway plays a minor role in the metabolism of cariprazine, the major pathway is via CYP3A4 (see section 5.2).
Pot, pri kateri posreduje CYP2D6, ima manjšo vlogo pri presnovi kariprazina, glavna pot poteka prek CYP3A4 (glejte poglavje 5.2).
(Uncommon side effect)
(Občasen neželeni učinek)
If you were taking another medicine to treat schizophrenia before starting Reagila, your doctor will decide whether to stop the other medicine gradually or immediately and how to adjust the dose of Reagila.
Če ste pred jemanjem zdravila Reagila jemali drugo zdravilo za zdravljenje shizofrenije, se bo zdravnik odločil, ali boste z jemanjem prejšnjega antipsihotika prenehali postopoma ali takoj, in ali je potrebna prilagoditev odmerka kariprazina.
Side effects with not known frequency (frequency cannot be estimated from the available data) - inflammation of the liver (pain in the upper right abdomen, yellowing of the eye and skin,
Neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) - vnetje jeter (bolečine v spodnjem delu trebuha, porumenelost oči in kože, šibkost, zvišana telesna temperatura)
Hypertrophy of the adrenal gland cortex was observed at 4.1 times the clinical exposure at the MRHD in rats (females only) and at clinically relevant total cariprazine plasma concentrations in mice.
Hipertrofijo korteksa nadledvične žleze so opazili pri 4,1-kratniku kliničnega odmerka MRHD pri podganah (le samice) in pri klinično pomembnih skupnih koncentracijah kariprazina v plazmi pri miših.
The capsules are filled with white to yellowish white powder.
Kapsule so napolnjene z belim do rumenkasto belim praškom.
However the therapeutic effect of cariprazine may be mediated through a combination of partial agonist activity at dopamine D3, D2 (Ki values of 0.085-0.3 nM versus 0.49-0.71 nM respectively) and serotonin 5-HT1A receptors (Ki values of 1.4-2.6 nM), and antagonist activity at serotonin 5-HT2B, 5-HT2A and histamine H1 receptors (Ki values of 0.58-1.1 nM, 18.8 nM and 23.3 nM, respectively).
Vendar pa je lahko terapevtski učinek kariprazina posledica kombinacije delnega agonističnega učinka na receptorje dopamina D3, D2 (vrednosti Ki 0,085 do 0,3 nM v primerjavi z 0,49 do 0,71 nM) in serotoninske receptorje 5HT1A (vrednosti Ki 1,4 do 2,6 nM) ter antagonističnega učinka na serotoninske receptorje 5HT2B, 5HT2A in histaminske receptorje H1 (vrednosti Ki 0,58 do 1,1 nM, 18,8 nM in 23,3 nM).
Administration of cariprazine to pregnant rats during the period of organogenesis, throughout pregnancy and lactation at clinically relevant exposures decreased postnatal survival, birth weight, and post-weaning body weight of first generation pups.
Dajanje kariprazina brejim podganam v obdobju organogeneze, v času brejosti in laktacije v klinično pomembnih izpostavljenostih je pri prvi generaciji mladičev zmanjšalo preživetje po porodu, telesno maso ob porodu in telesno maso po odstavitvi.
Alcohol should be avoided when taking Reagila.
Med jemanjem zdravila Reagila se je treba izogibati alkoholu.
In the placebo-controlled part of the long-term maintenance of effect study EPS was 13.7% in the cariprazine group compared to 3.0% in the placebo treated patients.
V s placebom nadzorovanem delu dolgoročne študije vzdrževanja učinkovitosti so EPS opazili pri 13,7 % bolnikov v skupini s kariprazinom v primerjavi s 3,0 % v skupini s placebom.
Gastrooesopha geal reflux disease
bruhanje gastroezofagealna refluksna bolezen disfagija
Ketoconazole, a strong CYP3A4 inhibitor, caused two fold increase in plasma exposure for total cariprazine (sum of cariprazine and its active metabolites) during short-term (4 days) co-administration, either if unbound or unbound+bound moieties considered.
Ketokonazol, močan zaviralec CYP3A4, je pri kratkotrajnem sočasnem dajanju (4 dni) povzročil dvakratno povečanje izpostavljenosti skupnemu kariprazinu v plazmi (vsota kariprazina in njegovih aktivnih presnovkov), bodisi če se gleda nevezano ali nevezano + vezano učinkovino.
After repeated administration plasma exposure of cariprazine and its two major active metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), increases proportionally over the therapeutic dose range of 1.5 to 6 mg.
Po večkratnem dajanju se plazemska izpostavljenost kariprazinu in njegovima dvema glavnima aktivnima presnovkoma, desmetil kariprazinu (DCAR) in didesmetil kariprazinau (DDCAR), v razponu terapevtskih odmerkov od 1,5 do 6 mg povečuje sorazmerno.
MedDRA System Organ Class
MedDRA Organski sistem
In the short term studies, there were slightly greater mean increases in body weight in the cariprazine group compared to the placebo group; 1 kg and 0.3 kg, respectively.
V kratkoročnih študijah so opazili blago povprečno zvečanje telesne mase v skupini s kariprazinom v primerjavi s skupino s placebom; 1 kg oz. 0,3 kg.
Cariprazine is well absorbed after oral administration.
Kariprazin se po peroralnem vnosu dobro absorbira.
If your baby develops any of these symptoms you should contact your doctor.
Če se pri otroku razvije kateri od teh simptomov, se obrnite na zdravnika.
Transparent hard PVC/PE/PVDC blister heat-sealed with hard aluminium foil backing packed in folded carton box.
Prozorni trdi pretisni omot iz PVC/PE/PVDC, toplotno zavarjen s trdo aluminijasto folijo na hrbtni strani, pakiran v škatlo.
The two major active metabolites, desmethyl cariprazine and didesmethyl cariprazine have a similar in vitro receptor binding and functional activity profile as the parent drug.
Dva glavna aktivna presnovka, desmetil kariprazin in didesmetil kariprazin, imata in vitro podobno vezavo na receptorje in profil funkcionalne aktivnosti kot matična učinkovina.
Inflammation was observed in the lungs of dogs dosed for 1 year with a NOAEL at AUC exposures 2.7 (males) and 1.7 (females) times the clinical exposure at the MRHD.
Vnetje so opazili v pljučih psov, ki so jim vsak dan 1 leto dajali NOAEL pri izpostavljenosti AUC 2,7-kratnik (samci) in 1,7-kratnik (samice) klinične izpostavljenosti pri MRHD.
What Reagila looks like and contents of the pack
Izgled zdravila Reagila in vsebina pakiranja
The capsules are filled with white to yellowish white powder mixture.
Kapsule so napolnjene z mešanico belega do rumenkasto belega praška.
° decreased level of thyroid stimulating hormone (TSH) in the blood
° zmanjšana raven ščitnico stimulirajočega hormona (TSH, thyroid stimulating hormone) v krvi
In the negative symptom study EPS was reported in 14.3% in the cariprazine group and 11.7% in the risperidone treated patients.
V študiji negativnih simptomov so o EPS poročali pri 14,3 % bolnikov v skupini s kariprazinom in 11,7 % bolnikov, zdravljenih z risperidonom.
Titanium dioxide (E 171) Gelatin
titanov dioksid (E 171) želatina
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, elevated serum creatine phosphokinase levels, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Klinični znaki NMS so hiperpireksija, mišična togost, zvišane ravni kreatin fosfokinaze v serumu, spremenjen duševni status in znaki avtonomne labilnosti (nereden utrip ali krvni tlak, tahikardija, diaforeza in motnje srčnega ritma).
Cariprazine should be used with caution in patients with risk factors for stroke.
Kariprazin je treba uporabljati previdno pri bolnikih z dejavniki tveganja za možgansko kap.
The exposure (AUC of total cariprazine) at the no-observed-adverse-effectlevel (NOAEL) for ocular toxicity is 4.2-fold the clinical AUC exposure at the maximal recommended human dose (MRHD) of 6 mg/day.
Izpostavljenost (AUC skupnega kariprazina) pri koncentraciji, pri kateri ni opaznih neželenih učinkov (NOAEL, no-observed-adverse-effect-level), za oksičnost za oči je 4,2-kratnik klinične izpostavljenosti AUC pri največjem priporočenem odmerku pri človeku (MRHD, maximal recommended human dose) 6 mg/dan.
If you forget to take Reagila
Če ste pozabili vzeti zdravilo Reagila
Photophobia Cataract
Fotofobija, katarakta
Switching from other antipsychotics to cariprazine When switching from another antipsychotic to cariprazine gradual cross-titration should be considered, with gradual discontinuation of the previous treatment while cariprazine treatment is initiated.
Pri prehodu z drugega antipsihotika na kariprazin je treba razmisliti o postopnem navzkrižnem titriranju, s postopnim ukinjanjem predhodnega zdravljenja ob uvedbi zdravljenja s kariprazinom.
The total active moiety (CAR+DCAR+DDCAR) exposure (AUC and Cmax) decreased by 21-22% and 13-15% in mild or moderate hepatic impairment (HI), respectively, compared to healthy subjects if unbound + bound concentrations were considered, while for unbound total moiety a decrease of 1213% and an increase of 20-25% were calculated in mild HI patients and in moderate HI patients, respectively, after multiple dosing of cariprazine.
Skupna izpostavljenost aktivni učinkovini (CAR + DCAR + DDCAR) (AUC in Cmax) se je zmanjšala za 21 % do 22 % pri blagi ter za 13 % do 15 % pri zmerni okvari jeter v primerjavi z zdravimi prostovoljci, če so se upoštevale nevezane + vezane koncentracije, medtem ko so za nevezano skupno učinkovino opazili zmanjšanje za 12 % do 13 % pri bolnikih z blago jetrno okvaro in povečanje za 20 % do 25 % pri bolnikih z zmerno jetrno okvaro, po večkratnem odmerjanju kariprazina.
In the negative symptom study, the mean change of body weight was -0.3 kg for cariprazine and +0.6 kg for risperidone and PCS weight gain was observed in 6% of the cariprazine group while 7.4% of the risperidone group.
V študiji negativnih simptomov je bila povprečna sprememba telesne mase -0,3 kg za kariprazin in +0,6 kg za risperidon in potencialno klinično pomembno zvečanje telesne mase so opazili pri 6 % v skupini s kariprazinom ter pri 7,4 % v skupini z risperidonom.
Reagila is indicated for the treatment of schizophrenia in adult patients.
4.1 Terapevtske indikacije Zdravilo Reagila je indicirano za zdravljenje shizofrenije pri odraslih bolnikih.
Metabolism of cariprazine and its major active metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), is mediated mainly by CYP3A4 with a minor contribution of CYP2D6.
Pri presnovi kariprazina in njegovih glavnih presnovkov, desmetil kariprazina (DCAR) in didesmetil kariprazina (DDCAR), v največji meri posreduje CYP3A4 z manjšim prispevkom CYP2D6.
Totally, 751 patients with acute symptoms of schizophrenia received cariprazine 3-9 mg/day for 20 weeks, of whom 337 received cariprazine in the dose-range of 3 or 6 mg/day.
20 tednov prejemali kariprazin od 3 do 9 mg/dan, od katerih je 337 prejemalo kariprazin v odmerku 3 ali 6 mg/dan.
Cariprazine and its major active metabolites are not substrates of P-glycoprotein (P-gp), the organic anion transporting polypeptide 1B1 and 1B3 (OATP1B1 and OATP1B3), and the breast cancer resistance protein (BCRP).
Kariprazin in njegovi glavni aktivni presnovki niso substrati P-glikoproteina (P-gp), organskega anionskega transportnega polipeptida 1B1 in 1B3 (OATP1B1 in OATP1B3) in proteina odpornosti pri raku dojke (BCRP, breast cancer resistance protein).
Therefore close monitoring in the first phase of treatment is important.
Akatizija se razvije zgodaj med zdravljenjem, zato je pomembno natančno spremljanje v prvi fazi zdravljenja.
The same information is also available on the following URL: www.reagila.com
Iste informacije so na voljo tudi na naslednji spletni strani: www.reagila.com »Vključiti kodo QR« + www.reagila.com
If you stop taking Reagila
Če ste prenehali jemati zdravilo Reagila
Co-administration of cariprazine with strong and moderate inducers of CYP3A4 may result in a significant decrease in total cariprazine exposure, therefore the co-administration of cariprazine and strong or moderate CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort (Hypericum perforatum), bosentan, efavirenz, etravirine, modafinil, nafcillin) is contraindicated (see section 4.3).
Sočasna uporaba kariprazina z močnimi in zmernimi induktorji CYP3A4 lahko povzroči pomembno zmanjšanje skupne izpostavljenosti kariprazinu, zato je sočasno dajanje kariprazina in močnih ali zmernih induktorjev CYP3A4 (npr. karbamazepina, fenobarbitala, fenitoina, rifampicina, šentjanževke (Hypericum perforatum), bosentana, efavirenza, etravirina, modafinila, nafcilina) kontraindicirana (glejte poglavje 4.3).
Risk of cerebrovascular accidents (CVA)
Tveganje za cerebrovaskularne dogodke
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako *
° increased blood glucose (blood sugar), increased bile pigment (bilirubin) in the blood
° zvišana raven glukoze v krvi (krvnega sladkorja), zvišana raven žolčnega pigmenta (bilirubina)
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ
Women of childbearing potential must use effective contraception during Reagila treatment.
Ženske v rodni dobi morajo med zdravljenjem z zdravilom Reagila uporabljati učinkovito kontracepcijo.
Cariprazine and its metabolites are excreted in milk of rats during lactation (see section 5.3).
Kariprazin in njegovi presnovki so se pri podganah v laktaciji izločali v mleko (glejte poglavje 5.3).
The effect of cariprazine on human fertility has not been evaluated.
Učinkov kariprazina na sposobnost razmnoževanja pri ljudeh niso ugotavljali.
Cushing's syndrome - when the body produces an excess of cortisol (medicines containing ketoconazole) depression (herbal therapy containing St. John's wort (Hypericum perforatum) and medicines containing nefazodone) epilepsy and seizures (medicines containing carbamazepine, phenobarbital and phenytoin) heart disease (medicines containing diltiazem and verapamil) sleepiness (medicines containing modafinil) high blood pressure in the lungs (medicines containing bosentan).
Cushingovega sindroma - če v telesu nastaja preveč kortizola (zdravila, ki vsebujejo ketokonazol) depresije (zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum) in zdravila, ki vsebujejo nefazodon) epilepsije in epileptičnih napadov (zdravila, ki vsebujejo karbamazepin, fenobarbital in fenitoin) bolezni srca (zdravila, ki vsebujejo diltiazem in verapamil) nespečnosti (zdravila, ki vsebujejo modafinil) visokega krvnega tlaka v pljučih (zdravila, ki vsebujejo bosentan).
However, a statistically significant difference (p< 0.001) in favour of cariprazine over risperidone was observed from Week 10 onward (Table 2).
Vendar pa so opazili statistično značilno razliko (p < 0,001) v korist kariprazina glede na risperidon od 10. tedna naprej (preglednica 2).
In dogs, reversible hypertrophy/hyperplasia and vacuolation/vesiculation of the adrenal gland cortex were observed with a NOAEL 4.2 times the clinical exposure at the MRHD.
Pri psih so opazili reverzibilno hipertrofijo/hiperplazijo in vakuolacijo/vezikulacijo korteksa nadledvične žleze z NOAEL, ki je 4,2-kratnik klinične izpostavljenosti pri MRHD 6 mg/dan.
In the preclinical studies of cariprazine lens opacity/cataract was detected in dogs (see sections 4.8 and 5.3).
V predkliničnih študijah s kariprazinom so pri psih odkrili motnjavo leče/katarakto (glejte poglavji 4.8 in 5.3).
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotics - Frequency unknown.
Pri antipsihotikih so poročali o primerih venske trombembolije, vključno s primeri pljučne embolije in primeri globoke venske tromboze, z neznano pogostnostjo.
Stabilized patients were then randomised to receive fixed doses of 3 or 6 mg cariprazine (n=51) or placebo (n=51) in a double-blind manner for up to 72 weeks.
6 mg kariprazina (n = 51) ali placeba (n = 51) v obdobju do 72 tednov na dvojno slepi način.
Concomitant administration of strong or moderate CYP3A4 inducers (see section 4.5).
Sočasna uporaba močnih ali zmernih induktorjev CYP3A4 (glejte poglavje 4.5).
Elimination of cariprazine and its major active metabolites is mainly through hepatic metabolism.
Izločanje kariprazina in njegovih glavnih aktivnih presnovkov poteka pretežno z jetrno presnovo.
Switching to another antipsychotic from cariprazine When switching to another antipsychotic from cariprazine, no gradual cross-titration is needed, the new antipsychotic should be initiated in its lowest dose while cariprazine is discontinued.
Pri prehodu na drug antipsihotik s kariprazina postopno navzkrižno titriranje ni potrebno, nov antipsihotik je treba uvesti v najmanjšem odmerku in prekiniti zdravljenje s kariprazinom.
Breast-feeding should be discontinued during treatment with cariprazine.
Med zdravljenjem s kariprazinom je treba prenehati z dojenjem.
However, a statistically significant difference (p=0.002) in favour of cariprazine over risperidone was observed from Week 14 onward (Table 2).
Vendar pa so opazili statistično značilno razliko (p = 0,002) v korist kariprazina glede na risperidon od 14. tedna naprej (preglednica 2).
An approximately 3-fold increased risk of cerebrovascular adverse reactions has been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics.
V randomiziranih, s placebom nadzorovanih kliničnih preskušanjih so v populaciji dementnih bolnikov ob uporabi nekaterih atipičnih antipsihotikov zabeležili 3-kratno povečanje tveganja za cerebrovaskularne neželene učinke.
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Neželeni učinki so navedeni po pogostnosti, pri čemer so najpogostejši navedeni najprej, po naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
There is no specific antidote to cariprazine.
Specifični antidot za kariprazin ni znan.
Your doctor will therefore check your weight regularly.
Zato bo zdravnik redno preverjal vašo telesno maso.
How to take Reagila
Kako jemati zdravilo Reagila
In vivo non-clinical studies demonstrated that cariprazine occupies D3 receptors to a similar extent as D2 receptors at pharmacologically effective doses.
Predklinične študije in vivo so pokazale, da pri farmakološko učinkovitih odmerkih kariprazin zasede receptorje D3 v podobnem obsegu kot receptorje D2.
България ТП „Гедеон Рихтер АД”
ТП „Гедеон Рихтер АД” Teл.
- seizure - loss of memory, loss of speech - eye discomfort in bright light - clouding of the lens in the eye leading to a decrease in vision (cataract) - difficulty in swallowing - reduced levels of a type of white blood cells, this can make you more susceptible to infections - underactive thyroid gland
- epileptični napad - izguba spomina, izguba govora - nelagodje očes ob močni svetlobi motnjava leče v očesu, kar povzroči poslabšanje vida (katarakta) - težave s požiranjem - zmanjšane števila vrste belih krvnih celic, zaradi česar ste lahko bolj nagnjeni k okužbam - premalo aktivna ščitnica
The primary endpoint was change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score and the secondary endpoint was change from baseline to week 6 in the Clinical Global Impressions-Severity (CGI-S) score in all acute schizophrenia studies.
V vseh študijah akutne shizofrenije je bila primarni opazovani dogodek sprememba od izhodišča do 6. tedna po lestvici za ocenjevanje pozitivnega in negativnega sindroma (PANSS, Positive and Negative Syndrome Scale), drugi opazovani dogodek pa je bila sprememba od izhodišča do 6. tedna po lestvici za ocenjevanje celokupnega kliničnega vtisa glede resnosti (CGI-S, Clinical Global Impressions-Severity).
Cariprazine has not been evaluated in patients with severe (CrCl < 30 mL/min) renal impairment (see section 4.2).
Kariprazina niso ocenili pri bolnikih s hudo (CrCl < 30 ml/min) okvaro ledvic (glejte poglavje 4.2).
Hepatic impairment No dose adjustment is required in patients with mild to moderate hepatic impairment (Child-Pugh score between 5-9).
Pri bolnikih z blago do zmerno okvaro jeter odmerka ni treba prilagajati (seštevek od 5 do 9 po ChildPughu).
Seizures and convulsions
Epileptični napadi in konvulzije
Reagila 1.5 mg and Reagila 3 mg hard capsules are available in pack sizes containing 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Zdravilo Reagila 1,5 mg in Reagila 3 mg trde kapsule so na voljo v velikostih pakiranja po 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 ali 98 trdih kapsul.
In other clinical trials, only a few, non-serious, QT-prolongations have been reported with cariprazine.
V drugih kliničnih preskušanjih s kariprazinom so opazili le nekaj podaljšanj intervala QT, ki niso bila resna.
PANSS total (MMRM) RGH-MD-16 (n=711)
RGH-MD-16 (n = 711) Placebo
1Sleep disorders: Insomnia, Abnormal dreams/nightmare, Circadian rhythm sleep disorder, Dyssomnia, Hypersomnia, Initial insomnia, Middle insomnia, Nightmare, Sleep disorder, Somnambulism, Terminal insomnia
1Motnje spanja: nespečnost, nenormalne sanje/nočne more, motnje cirkadianega ritma spanja, dissomnija, hipersomnija, začetna nespečnost, vmesna nespečnost, nočne more, motnje spanja, somnambulizem, končna nespečnost
Close medical supervision and monitoring should continue until the patient recovers.
Dokler bolnik ne okreva, je potrebno pozorno spremljanje in zdravniški nadzor.
Akathisia was reported in 10.0% in patients treated with cariprazine and 5.2% in the risperidone group.
O akatiziji so poročali pri 10,0 % bolnikov, zdravljenih s kariprazinom, in 5,2 % v skupini z risperidonom.
Cariprazine has minor or moderate influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Kariprazin ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.