natgillin/translations-raw huggingface dataset:
There was a dose-dependent occupancy of brain dopamine D3 and D2 receptors (with preferential occupancy in regions with higher D3 expression) in patients with schizophrenia within the therapeutic dose range of cariprazine for 15 days.
Pri bolnikih s shizofrenijo so v terapevtskem razponu odmerkov kariprazina opazili 15-dnevno od odmerka odvisno zasedenost možganskih receptorjev D3 in D2 (s preferenčno zasedenostjo v regijah z večjo izraženostjo D3).
Compared to healthy subjects, patients with either mild or moderate hepatic impairment had up to approximately 25% higher exposure (Cmax and AUC) for cariprazine and up to approximately 45% lower exposure for the major active metabolites, desmethyl cariprazine and didesmethyl cariprazine, following the single dose of 1 mg cariprazine or 0.5 mg cariprazine for 14 days.
v primerjavi z zdravimi bolniki so imeli bolniki z blago ali zmerno okvaro jeter po enkratnem odmerku 1 mg kariprazina ali 0,5 mg kariprazina v obdobju 14 dni do približno 25 % večjo izpostavljenost (Cmax in AUC) kariprazinu in do približno 45 % manjšo izpostavljenost glavnima aktivnima presnovkoma, desmetil kariprazinu in didesmetil kariprazinu.
Both cariprazine- and risperidone-treated patient groups have shown statistically significant improvement in the change from baseline for the primary efficacy parameter, PANSS factor score for negative symptoms (PANSS-FSNS) (p< 0.001).
Tako skupna bolnikov, zdravljenih s kariprazinom, kot skupina bolnikov, zdravljenih z risperidonom, je imela statistično značilno izboljšanje pri spremembi od izhodišča za primarni parameter učinkovitosti, tj. faktorska vrednost po lestvici PANSS za negativne simptome (PANSS-FSNS) (p < 0,001).
QUALITATIVE AND QUANTITATIVE COMPOSITION Reagila 1.5 mg hard capsules
KAKOVOSTNA IN KOLIČINSKA SESTAVA Reagila 1,5 mg trde kapsule
Cariprazine and its major active metabolites are not inhibitors of transporters OATP1B1, OATP1B3, BCRP, organic cation transporter 2 (OCT2), and organic anion transporters 1 and 3 (OAT1 and OAT3) in vitro.
Kariprazin in njegova glavna aktivna presnovka in vitro niso zaviralci prenašalcev OATP1B1, OATP1B3, BCRP, prenašalca organskih kationov 2 (OCT2) in prenašalcev organskih anionov 1 in 3 (OAT1 in OAT3).
If you are using hormonal contraceptives a so-called barrier method(e.g. condom or diaphragm) should also be used.
Če uporabljate hormonske kontraceptive, morate uporabljati tudi pregradno metodo (npr. kondom ali diafragmo).
Cariprazine should be used cautiously in patients with history of seizures or with conditions that potentially lower the seizure threshold.
Kariprazin je treba uporabljati previdno pri bolnikih z anamnezo epileptičnih napadov ali stanj, ki lahko znižajo prag za epileptične napade.
In the long-term , maintenance of effect study, during the open-label phase, > 60 msec increase of from baseline was observed in 12 patients (1.6%) for QTcB and in 4 patients (0.5%) for QTcF.
V dolgoročni študiji vzdrževanja učinka so v odprti fazi opazili povečanje > 60 msec od izhodišča pri 12 bolnikih (1,6 %) za QTcB in pri 4 bolnikih (0,5 %) za QTcF.
Reagila with food, drink and alcohol You should not drink grapefruit juice during treatment with Reagila.
Med zdravljenjem z zdravilom Reagila ne smete piti soka grenivke.
- visual impairment.
- motnje vida.
No dose adjustment is required in patients with mild to moderate renal impairment (Creatinine Clearance (CrCl) ≥ 30 mL/min and < 89 mL/min).
Pri bolnikih z blago do zmerno okvaro ledvic (očistek kreatinina (CrCl, creatinine clearance) ≥ 30 ml/min in < 89 ml/min) odmerka ni treba prilagajati.
Reagila 3 mg, 4.5 mg and 6 mg hard capsules contain Allura red AC (E 129), which may cause allergic reactions.
3 mg, 4,5 mg in 6 mg trde kapsule zdravila Reagila vsebujejo barvilo alurno rdeče AC (E129), ki lahko povzroči alergijske reakcije.
Akathisia was reported in 3.9% in patients treated with cariprazine, versus 2.0% in the placebo group.
O akatiziji so poročali pri 3,9 % bolnikov, zdravljenih s kariprazinom, v primerjavi z 2,0 % v skupini s placebom.
During the double-blind treatment period, > 60 msec increases from baseline in QTcB were observed in 3 cariprazine-treated patients (3.1%) and 2 placebo-treated patients (2%).
Med dvojno slepim obdobjem zdravljenja so > 60 msek povečanje od izhodišča pri QTcB opazili pri 3 bolnikih, zdravljenih s kariprazinom (3,1 %) in pri 2 bolnikih, ki so prejemali placebo (2 %).
Women of childbearing potential must use highly effective contraception while taking Reagila and for at least 10 weeks after stopping treatment.
Ženske v rodni dobi morajo med jemanjem zdravila Reagila in še vsaj 10 tednov po prenehanju zdravljenja uporabljati zelo učinkovito kontracepcijsko metodo.
Parkinsonism was experienced in 7.8% and 1.0% in cariprazine and placebo group respectively.
Parkinsonizem je doživelo 7,8 % bolnikov v skupini s kariprazinom in 1,0 % v skupini s placebom.
Both cariprazine- and risperidone-treated patient groups have shown statistically significant improvement in the change from baseline for the secondary efficacy parameter, Personal and Social Performance (PSP) total score (p< 0.001).
Tako skupina bolnikov, zdravljenih s kariprazinom, kot skupina bolnikov, zdravljenih z risperidonom, je pokazala statistično značilno izboljšanje pri spremembi od izhodišča za sekundarni parameter učinkovitosti, tj. skupna ocena (p < 0,001) po lestvici osebnega in socialnega delovanja (PSP, Personal and Social Performance).
In clinical trials, only a few, non-serious, QTprolongations have been reported with cariprazine (see section 4.8).
V kliničnih preskušanjih so s kariprazinom opazili le nekaj podaljšanj intervala QT, ki niso bila resna (glejte poglavje 4.8).
Concomitant administration of strong or moderate CYP3A4 inhibitors (see section 4.5).
Sočasna uporaba močnih ali zmernih zaviralcev CYP3A4 (glejte poglavje 4.5).
Accidental acute overdose (48 mg/day) was reported in one patient.
Pri enem bolniku so poročali o nenamernem akutnem prevelikem odmerjanju (48 mg/dan).
Thereafter the dose can be increased slowly in 1.5 mg increments to a maximum dose of 6 mg/day, if needed.
Odmerjanje Priporočen začetni odmerek kariprazina je 1,5 mg enkrat na dan. Nato se lahko odmerek po potrebi počasi povečuje v korakih po 1,5 mg do največjega odmerka 6 mg/dan.
Even after treatment is stopped, contraception must be used for at least 10 weeks after your last dose of Reagila.
Tudi po koncu zdravljenja morajo uporabljati kontracepcijo še vsaj 10 tednov po zadnjem odmerku zdravila Reagila.
Visual acuity reduced
motnje akomodacije, zmanjšana ostrina vida
2Akathisia: Akathisia, Psychomotor hyperactivity, Restlessness 3Parkinsonism: Akinesia, Bradykinesia, Bradyphrenia, Cogwheel rigidity, Extrapyramidal disorder, Gait disturbance, Hypokinesia, Joint stiffness, Tremor, Masked facies, Muscle rigidity, Musculoskeletal stiffness, Nuchal rigidity, Parkinsonism
2Akatizija: akatizija, psihomotorična hiperaktivnost, nemir 3Parkinsonizem: akinezija, bradikinezija, bradifrenija, okorelost po tipu zobatega kolesa, ekstrapiramidne motnje, motnje hoje, hipokinezija, okorelost sklepov, tremor, obraz maske, togost mišic, mišično-skeletna togost,
Patients with an established diagnosis of diabetes mellitus or patients with risk factors for diabetes mellitus (e.g. obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should be monitored for serum glucose levels.
(npr. debelost, sladkorna bolezen v družinski anamnezi), ki se začenjajo zdraviti z atipičnimi antipsihotiki, je treba spremljati ravni glukoze v serumu.
Cariprazine has not been evaluated in patients with severe hepatic impairment (Child-Pugh Class C) (see section 4.2).
Kariprazina niso ocenili pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) (glejte poglavje 4.2).
There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress or feeding disorder.
hipertoniji, hipotoniji, tremorju, somnolenci, dihalni stiski in motnjah prehranjevanja.
Phospholipidosis was observed in the lungs of rats, dogs, and mice (with or without inflammation) and in the adrenal gland cortex of dogs at clinically relevant exposures.
Pri klinično pomembnih izpostavljenostih so opazili fosfolipidozo na pljučih podgan, psov in miši (z vnetjem ali brez) in korteksu nadledvične žleze psov .
1103 Budapest HUNGARY
1103 Budimpešta
Cases of venous thromboembolism have been reported with antipsychotic medicinal products.
Pri uporabi antipsihotičnih zdravil so poročali o primerih venske trombembolije.
° abnormal sodium level in the blood
° nenormalna raven natrija v krvi
By the end of the trial 49.0% of placebo-treated patients versus 21.6% of cariprazine-treated patients had a relapse of schizophrenic symptoms.
Do konca preskušanja je imelo ponovitev simptomov shizofrenije 49,0 % bolnikov, zdravljenih s placebom, v primerjavi s 21,6 % bolnikov, zdravljenih s kariprazinom.
DCAR is further metabolized by CYP3A4 and to a lesser extent by CYP2D6 into DDCAR and HDCAR.
DCAR se s CYP3A4 in v manjši meri s CYP2D6 nadalje presnovi v DDCAR in HDCAR.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 13 July 2017
13. julij 2017
If you are using hormonal contraceptives a so-called barrier method (e.g.condom or diaphragma) should also be used.
Če uporabljate hormonske kontraceptive, morate uporabljati tudi tako imenovano pregradno metodo (kondom ali diafragmo).
Akathisia2 Parkinsonism3
Bolezni živčevja akatizija parkinsonize m3
Persistent predominant negative symptoms were defined as symptoms lasting for a period of at least 6 months with high level of negative symptoms and low level of positive symptoms [(PANSS factor score for negative symptoms ≥ 24, a score of ≥ 4 on a minimum 2 of the 3 PANSS items (N1: flat affect, N4: avolition, and N6: poverty of speech) and PANSS factor score for positive symptoms ≤ 19].
≥ 24, vrednost ≥ 4 za vsaj 2 od 3 postavk na lestvici PANSS (N1: čustvena praznost, N4: pomanjkanje zagona in N6: osiromašen govor) in faktorska vrednost po lestvici PANSS za pozitivne simptome ≤ 19].
In a third multinational placebo controlled study using fixed/flexible doses of 3.0-6.0 mg and 6.0-9.0 mg cariprazine, both cariprazine doses groups showed statistically significant improvement in both primary as well as secondary endpoint compared to placebo.
V tretji mednarodni, s placebom nadzorovani študiji, v kateri so uporabljali fiksne/prilagodljive odmerke od 3,0 mg do 6,0 mg in od 6,0 mg do 9,0 mg kariprazina, sta obe skupini z odmerkoma kariprazina pokazali statistično značilno izboljšanje tako primarnega kot sekudnarnega opazovanega dogodka v primerjavi s placebom.
Change LS mean (SE)
± SD (SE)
Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain Allura red AC (E129).
3 mg, 4,5 mg in 6 mg trde kapsule zdravila Reagila vsebujejo barvilo alurno rdeče AC (E129).
In the cariprazine clinical studies the incidence of ALT, AST elevation ADRs occurred in 2.2% of cariprazine-, 1.6% of risperidone- and 0.4% of placebo-treated patients.
kliničnih študijah s kariprazinom je bila incidenca zvišanja vrednosti ALT, AST 2,2 % pri kariprazinu, 1,6 % pri risperidonu in 0,4 % pri placebu.
Use of cariprazine is not recommended in patients with severe renal impairment (see section 5.2).
Uporaba kariprazina se pri bolnikih s hudo okvaro ledvic ne priporoča (glejte poglavje 5.2).
This medicine is not recommended for children and adolescents under 18 years due to the lack of data in these patients.
Zaradi pomanjkanja podatkov uporaba tega zdravila ni priporočljiva pri otrocih in mladostnikih,
A potentially fatal symptom complex referred to as neuroleptic malignant syndrome (NMS) has been reported in association with antipsychotic treatment.
V povezavi z zdravljenjem z antipsihotiki so poročali o sindromu, ki se imenuje nevroleptični maligni sindrom (NMS) in se lahko konča s smrtjo.
7 hard capsules 14 hard capsules 21 hard capsules 28 hard capsules 30 hard capsules 49 hard capsules 56 hard capsules 60 hard capsules 84 hard capsules 90 hard capsules 98 hard capsules
21 trdih kapsul 28 trdih kapsul 30 trdih kapsul 49 trdih kapsul
In clinical trials, glucose-related adverse reactions have been reported with cariprazine (see section 5.1).
V kliničnih preskušanjih s kariprazinom so poročali o neželenih učinkih, povezanih z glukozo (glejte poglavje 5.1).
Treatment difference versus placebo (95% CI)
Razlika zdravljenja v primerjavi s placebom Vrednost p
Cartons contain 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Škatla vsebuje 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 ali 98 trdih kapsul
Ocular symptoms/cataract
Očesni simptomi/katarakta
Women of childbearing potential must be advised to avoid pregnancy while on Reagila.
Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom Reagila ne zanosijo.
LIST OF EXCIPIENTS Also contains Allura red AC (E129).
3 SEZNAM POMOŽNIH SNOVI Vsebuje tudi barvilo alurno rdeče AC (E129).
In a multinational placebo controlled study using fixed doses of 1.5 mg, 3.0 mg and 4.5 mg cariprazine and 4.0 mg risperidone for assay sensitivity, all cariprazine doses and the active-control showed statistically significant improvement in both primary as well as secondary endpoint compared to placebo.
V mednarodni, s placebom nadzorovani študiji, v kateri so uporabljali fiksne odmerke 1,5 mg, 3,0 mg in 4,5 mg kariprazina ter 4,0 mg risperidona za občutljivost testa, so vsi odmerki kariprazina in aktivne kontrole pokazali statistično značilno izboljšanje tako primarnega kot sekudnarnega opazovanega dogodka v primerjavi s placebom.
Tel: +370 5 261 01 54
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Development of cataracts was observed in cariprazine non-clinical studies (see section 5.3).
V nekliničnih študijah s kariprazinom so opazili razvoj katarakt (glejte poglavje 5.3).
Female patients of child-bearing potential must use highly effective contraceptive methods during treatment and for at least 10 weeks following the last dose of Reagila.
Bolnice v rodni dobi morajo morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še vsaj 10 tednov po zadnjem odmerku zdravila Reagila.
were supportive of findings on the primary and secondary efficacy parameters.
izboljšanje v 26. tednu; p = 0,003) podpirajo izsledke primarnih in sekundarnih parametrov učinkovitosti.
Close supervision of high-risk patients should accompany antipsychotic therapy.
Ob antipsihotičnem zdravljenju je potreben natančen nadzor bolnikov z visokim tveganjem.
With cariprazine no QT interval prolongation was detected compared to placebo in a clinical trial designed to assess QT prolongation (see section 5.1).
V kliničnih preskušanjih, zasnovanih za ocenjevanje podaljšanja intervala QT, niso opazili podaljšanja intervala QT pri kariprazinu v primerjavi s placebom (glejte poglavje 5.1).
Your doctor will need to check your blood sugar regularly since it may be increased by Reagila.
Zdravnik bo moral redno preverjati vašo raven sladkorja v krvi,
Parkinsonism was experienced in 13.6%; 5.7%; 22.1% and 5.3% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively.
Parkinsonizem je doživelo 13,6% bolnikov, zdravljenih s kariprazinom, 5,7 % bolnikov, ki so dobivali placebo, 22,1 % bolnikov, zdravljenih z risperidonom, in 5,3 % bolnikov, zdravljenih z aripiprazolom.
In another multinational placebo controlled study using fixed doses of 3.0 mg, and 6.0 mg cariprazine and 10 mg aripiprazole for assay sensitivity, both cariprazine doses and the active-control showed statistically significant improvement in both primary as well as secondary endpoint compared to placebo.
V drugi mednarodni, s placebom nadzorovani študiji, v kateri so uporabljali fiksne odmerke 3,0 mg in 6,0 mg kariprazina ter 10 mg aripiprazola za občutljivost testa, sta oba odmerka kariprazina in aktivna kontrola pokazali statistično značilno izboljšanje tako primarnega kot sekudnarnega opazovanega dogodka v primerjavi s placebom.
Dysuria Pollakisuria
Okvara ledvic
Adverse drug reactions (ADRs) based upon pooled data from cariprazine schizophrenia studies are shown by system organ class and by preferred term.
Seznam neželenih učinkov v obliki preglednice Neželeni učinki zdravila na podlagi združenih podatkov študij kariprazina pri bolnikih s shizofrenijo so prikazani po organskih sistemih in s prednostnimi izrazi.
Use of cariprazine is not recommended in patients with severe hepatic impairment (see section 5.2).
Uporaba kariprazina se pri bolnikih s hudo okvaro jeter ne priporoča (glejte poglavje 5.2).
DDCAR is further metabolised to HDDCAR by CYP3A4.
DDCAR se s CYP3A4 nadalje presnovi v HDDCAR.
Signs of high blood sugar level are excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak.
Znaki visoke ravni sladkorja v krvi so pretirana žeja, obilno odvajanje seča, povečanje apetita in občutek šibkosti - imate epileptične napade (krče) ali epilepsijo v zdravstveni zgodovini.
- dementia (loss of memory and other mental abilities) especially if you are elderly - Parkinson's disease - if you have diabetes or risk factors for diabetes (e.g. obesity, or someone else in your family has diabetes).
- imate demenco (izgubo spomina in drugih duševnih sposobnosti), zlasti, če ste starejši
Cariprazine is metabolized by CYP3A4 and, to a lesser extent, by CYP2D6, to DCAR and HCAR.
CYP3A4 in v manjšem obsegu CYP2D6 presnavljata kariprazin v DCAR in HCAR.
Printing ink (white: 4.5 mg capsule)
Črnilo (belo: 4,5 mg kapsula)
No effects on male fertility were noted at exposures up to 4.8 times the clinical exposure at the MRHD.
Pri izpostavljenosti do 4,8-kratnik klinične izpostavljenosti pri MRHD niso opazili vpliva na plodnost pri samcih.
Capsule shell (1.5 mg capsule)
Ovojnica kapsule (kapsula 1,5 mg)
Reagila 1.5 mg hard capsules Reagila 3 mg hard capsules Reagila 4.5 mg hard capsules Reagila 6 mg hard capsules
Reagila 1,5 mg trde kapsule Reagila 3 mg trde kapsule Reagila 4,5 mg trde kapsule Reagila 6 mg trde kapsule
Vision blurred Eye irritation Intraocular pressure increased
Očesne bolezni zamegljen vid draženje očesa, povečanje očesnega tlaka,
4Dystonia: Blepharospasm, Dystonia, Muscle tightness, Oromandibular dystonia, Torticollis, Trismus 5Other extrapyramidal diseases and abnormal movement disorders: Balance disorder, Bruxism, Drooling, Dysarthria, Gait deviation, Glabellar reflex abnormal, Hyporeflexia, Movement disorder, Restless legs syndrome, Salivary hypersecretion, Tongue movement disturbance 6Dyskinesia: Choreoathetosis, Dyskinesia, Grimacing, Oculogyric crisis, Protrusion tongue
4Distonija: blefarospazem, distonija, mišična napetost, oromandibularna distonija, tortikolis, trizmus 5Druge ekstrapiramidne bolezni in motnje z nenormalnim gibanjem: motnje ravnovesja, bruksizem, slinjenje,
Capsule shell (6 mg capsule)
Ovojnica kapsule (kapsula 6 mg)
You cannot take certain medicines together with Reagila (see section “Do not take Reagila”).
(glejte poglavje „Ne jemljite zdravila Reagila“).
DCAR and DDCAR were not inhibitors of transporter P-gp although cariprazine was a P-gp inhibitor in the intestine (see section 4.5).
DCAR in DDCAR nista bila zaviralca prenašalca P-gp,
During the long-term, open-label treatment period in, 3 patients (0.4%) had QTcB > 500 msec, one of whom also had QTcF > 500 msec. A > 60 msec increase from baseline was observed in 7 patients (1%) for QTcB and in 2 patients (0.3%) for QTcF.
Med dolgoročnim obdobjem odprtega zdravljenja so imeli 3 bolniki (0,4 %) QTcB > 500 msek, ena ženska med njimi je imela tudi QTcF > 500 msek.
Reagila 4.5 mg and Reagila 6 mg hard capsules
Reagila 4,5 mg in Reagila 6 mg trde kapsule
Pregnancy, puerperium and perinatal conditions
Motnje v času nosečnosti, puerperija in perinatalnem obdobju odtegnitveni sindrom pri novorojencu
(Side effect with frequency not known - inexplicable muscle pains, muscle cramps or muscle weakness.
- nepojasnjene bolečine v mišicah, mišični krči ali mišična šibkost.
Brilliant blue FCF (E 133) Allura red AC (E 129) Titanium dioxide (E 171) Gelatin
briljantno modro FCF (E133) alurno rdeče AC (E129) titanov dioksid (E171) želatina
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalneg a prostora kolcanje
Capsule shell (3 mg capsule)
Ovojnica kapsule (kapsula 3 mg)
Total PSP at Baseline Total PSP at Week 26 Total PSP CfB to Week 26 CfB= change from baseline
Sprememba PANSS-FSNS od izhodišča do 26. tedna Skupni PSP ob izhodišču Skupni PSP v 26. tednu
QT prolongation can develop in patients treated with antipsychotics.
Spremembe EKG Pri bolnikih, zdravljenih z antipsihotiki, se lahko pojavi podaljšanje intervala QT.
- if you are taking medicines used to treat: hepatitis caused by the hepatitis C virus (medicines containing boceprevir and telaprevir) bacterial infections (medicines containing clarithromycin, telithromycin, erythromycin and nafcillin) tuberculosis (medicines containing rifampicin)
hepatitisa, ki ga povzroči virus hepatitisa C (zdravila, ki vsebujejo boceprevir in telaprevir bakterijskih okužb (zdravila, ki vsebujejo klaritromicin, telitromicin, eritromicin in nafcilin) tuberkuloze (zdravila, ki vsebujejo rifampicin) okužb s HIV (zdravila, ki vsebujejo kobicistat, indinavir, nelfinavir, ritonavir, sakvinavir, efavirenz in etravirin)
Reagila 1.5 mg and Reagila 3 mg hard capsules
Reagila 1,5 mg in Reagila 3 mg trde kapsule
Reagila 4.5 mg hard capsules
Reagila 4,5 mg trde kapsule
- depression - sudden and severe confusion - spinning sensation - unpleasant, abnormal sense of touch - drowsiness, lack of energy or a lack of interest in doing things - involuntary movements, most commonly of the tongue or face.
- dremavost, pomanjkanje energije ali pomanjkanje interesa za stvari - nehotni gibi, najpogosteje jezika ali obraza.
Safety and efficacy of cariprazine have not been evaluated in patients with severe hepatic impairment (Child-Pugh score between 10 and 15).
Varnosti in učinkovitosti kariprazina niso ocenili pri bolnikih s hudo okvaro jeter (ocena od
- feeling of restlessness and inability to sit still - Parkinsonism - a medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity), shuffling, steps, shaking, little or no facial expression, muscle stiffness, drooling
Bolezni živčevja - občutek nemira in nezmožnost mirnega sedenja - Parkinsonizem - zdravstveno stanje s številnimi različnimi simptomi, ki vključujejo zmanjšano ali upočasnjeno gibanje, počasnost misli, nehotni gibi pri upogibanju okončine (okorelost tipa zobatega kolesa), negotovi koraki, tresenje, slaba izraznost ali brezizraznost obraza, okorelost mišic, slinjenje) Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov)
HIV infections (medicines containing cobicistat, indinavir, nelfinavir, ritonavir, saquinavir, efavirenz and etravirine) fungal infections (medicines containing itraconazole, posaconazole, voriconazole and fluconazole)
glivičnih okužb (zdravila, ki vsebujejo itrakonazol, posakonazol, vorikonazol in flukonazol)
° increases in the level of creatine phosphokinase in the blood
° zvišana raven jetrnih encimov ° zvišana raven kreatin fosfokinaze v krvi
Cariprazine 1.5 mg/day 97.1 ± 9.13 -21.27 (1.77) -7.97 (-12.94, -3.01) 0.0017 Cariprazine 3 mg/day 97.2 ± 8.66 -21.45 (1.74) -8.16 (-13.09, -3.22) 0.0013 Cariprazine 4.5 mg/day 96.7 ± 9.01 -23.77 (1.74) -10.48 (-15.41, -5.55) < 0.0001 Risperidone 4 mg/day 98.1 ± 9.50 -29.27 (1.74) -15.98 (-20.91, -11.04) < 0.0001* RGH-MD-04 (n=604)
Kariprazin 4,5 mg/dan 96,7 ± 9,01 -23,77 (1,74) -10,48 (-15,41; -5,55) < 0,0001
Tardive dyskinesia is a syndrome consisting of potentially irreversible, rhythmical, involuntary movements, predominantly of the tongue and/or face that can develop in patients treated with antipsychotics.
pretežno jezika in/ali obraza, ki se lahko pojavijo pri bolnikih, zdravljenih z antipsihotiki.
Capsule shell (4.5 mg capsule)
Ovojnica kapsule (kapsula 4,5 mg)
Dystonia was observed in 1.8%; 0.2%; 3.6% and 0.7% in patients on cariprazine, placebo, risperidone and aripiprazole, respectively.
Distonijo so opazili pri 1,8 % bolnikov, zdravljenih s kariprazinom, 0,2 % bolnikov, ki so dobivali placebo, 3,6 % bolnikov, zdravljenih z risperidonom, in 0,7 % bolnikov, zdravljenih z aripiprazolom.