FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, pale, cold bodies and developmental delays (renal papillae not developed/underdeveloped and decreased auditory startle response in males) were observed in the absence of maternal toxicity.
Croatian: Osim toga, zabilježene su bljedoća i hladnoća tijela te zastoj u razvoju mladunčadi (nerazvijenost/nedovoljna razvijenost bubrežnih papila i smanjen odgovor na slušni podražaj u mužjaka) bez toksičnosti za majku.
English: Akathisia develops early in treatment.
Croatian: Aktazija se razvija u ranoj fazi liječenja.
English: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Croatian: Nuspojave su navedene prema učestalosti, počevši od najčešćih, u skladu sa sljedećom kategorizacijom: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000) vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: 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
Croatian: 21 tvrdih kapsula 28 tvrdih kapsula 30 tvrdih kapsula 49 tvrdih kapsula 56 tvrdih kapsula 60 tvrdih kapsula 84 tvrde kapsule 90 tvrdih kapsula 98 tvrdih kapsula
English: Cariprazine has not been evaluated in patients with severe (CrCl < 30 mL/min) renal impairment (see section 4.2).
Croatian: Kariprazin se nije ocjenjivao u bolesnika s teškim (CrCl < 30 ml/min) oštećenjem funkcije bubrega (vidjeti dio 4.2).
English: 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).
Croatian: Istodobna primjena kariprazina sa snažnim ili umjerenim induktorima CYP3A4 može dovesti do značajnog smanjenja izloženosti ukupnom kariprazinu, pa je istodobna primjena kariprazina sa snažnim ili umjerenim induktorima CYP3A4 (npr. karbamazepinom, fenobarbitalom, fenitoinom, rifampicinom, gospinom travom [Hypericum perforatum], bosentanom, efavirenzom, etravirinom, modafinilom, nafcilinom) kontraindicirana (vidjeti dio 4.3).
English: Slovenská republika
Croatian: Česká republika
English: Dose selection for an elderly patient should be more cautious.
Croatian: Potreban je dodatni oprez kod odabira doze u starijeg bolesnika.
English: No patients treated with cariprazine experienced QTc increases ≥ 60 msec from baseline, nor did any patient experience a QTc of > 500 msec in the study.
Croatian: Nijedan bolesnik liječen kariprazinom nije imao produljenje QTc intervala za ≥ 60 ms u odnosu na početnu vrijednost i nijedan bolesnik u ispitivanju nije imao QTc > 500 ms.
English: Pregelatinized (maize) starch Magnesium stearate
Croatian: Sadržaj kapsule prethodno geliran škrob (kukuruzni) magnezijev stearat
English: Cariprazine should be used cautiously in patients with history of seizures or with conditions that potentially lower the seizure threshold.
Croatian: Kariprazin treba primjenjivati uz oprez u bolesnika koji u anamnezi imaju napadaje ili stanja koja mogu smanjiti prag za konvulzije.
English: Drowsiness, dizziness and vision problems may occur during treatment with this medicine (see section 4).
Croatian: Tijekom liječenja ovim lijekom mogu se javiti omamljenost, omaglica i tegobe s vidom (pogledajte dio 4.).
English: 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.
Croatian: Bolesnice u reproduktivnoj dobi moraju koristiti visoko učinkovite metode kontracepcije tijekom liječenja i najmanje još 10 tjedana nakon posljednje doze Reagile.
English: 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.
Croatian: Kada se primjenjivao skotnim ženkama štakora tijekom organogeneze, skotnosti i laktacije, kariprazin je pri klinički značajnim razinama izloženosti smanjio postnatalno preživljenje, tjelesnu težinu pri okotu i prirast tjelesne težine u razdoblju nakon sisanja kod prve generacije mladunčadi.
English: 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.
Croatian: Kariprazin i njegovi glavni aktivni metaboliti nisu inhibirali prijenosnike OATP1B1 i OATP1B3, BCRP, prijenosnik organskih kationa-2 (OCT2) te prijenosnike organskih aniona 1 i 3 (OAT1 i OAT3) in vitro.
English: 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.
Croatian: Pri prelasku s nekog drugog antipsihotika na kariprazin potrebno je razmotriti postupnu ukriženu titraciju, uz postupan prekid prethodne terapije tijekom uvođenja liječenja kariprazinom.
English: Luxembourg/Luxemburg Recordati BVBA
Croatian: Luxembourg/Luxemburg
English: (Rare side effect) - symptoms related to blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Croatian: To mogu biti znakovi oštećenja mišića koje može uzrokovati vrlo ozbiljne probleme s bubrezima (Rijetka nuspojava) - simptome povezane s krvnim ugrušcima u venama, osobito u nogama (simptomi uključuju oticanje, bol i crvenilo noge), koji mogu putovati krvnim žilama do pluća, uzrokujući bol u prsnom košu i poteškoće s disanjem.
English: Holter monitor-derived electrocardiographic assessments were obtained in 129 patients over a twelve hour period at baseline and steady state.
Croatian: Provedene su elektrokardiografske procjene u 129 bolesnika na temelju 12-satnog EKG praćenja (Holter) na početku ispitivanja i u stanju dinamičke ravnoteže.
English: Change From Baseline to Week 6 in the PANSS Total Score in Studies of Acute Exacerbations of Schizophrenia-ITT Population
Croatian: Promjena od početne vrijednosti s početka ispitivanja do 6. tjedna u ukupnom rezultatu na PANSS ljestvici u ispitivanjima akutnih egzacerbacija shizofrenijeITT populacija Početna srednja vrijednost
English: Cariprazine 3 to 6 mg/day 96.3 ± 9.3 -22.8 (1.6) Cariprazine 6 to 9 mg/day 96.3 ± 9.0 -25.9 (1.7) CI = confidence interval; ITT = intent to treat; LS mean = least squares mean; PANSS = Positive and Negative Syndrome Scale.
Croatian: Kariprazin 3 do 6 mg/dan 96,3 ± 9,3 -22,8 (1,6) Kariprazin 6 do 9 mg/dan 96,3 ± 9,0 -25,9 (1,7) CI = interval pouzdanosti; ITT = populacija bolesnika predviđenih za liječenje; LS srednja vrijednost = srednja vrijednost dobivena metodom najmanjih kvadrata; PANSS = ljestvica pozitivnih i negativnih simptoma *u usporedbi s placebom
English: Hepatic impairment No dose adjustment is required in patients with mild to moderate hepatic impairment (Child-Pugh score between 5-9).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije jetre (Child-Pugh rezultat između 5 i 9).
English: 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.
Croatian: U pasa su primijećene reverzibilna hipertrofija/hiperplazija i vakuolizacija/vezikulacija kore nadbubrežne žlijezde uz 4,2 puta viši NOAEL od kliničke izloženosti pri maksimalnoj preporučenoj dozi za ljude.
English: If you are using hormonal contraceptives a so-called barrier method should also be used (see section “Pregnancy and breast-feeding” below).
Croatian: Ako koristite hormonske kontraceptive, potrebno je koristiti i takozvanu mehaničku metodu kontracepcije (vidjeti dio „Trudnoća i dojenje“ u nastavku).
English: Reagila should not be used by elderly patients with dementia (loss of memory).
Croatian: Stariji bolesnici s demencijom (gubitak pamćenja) ne smiju koristiti lijek Reagila.
English: You may experience dizziness from low blood pressure, or have abnormal heartbeats, you may feel sleepy, tired, or have abnormal body movements and find it difficult to stand or walk.
Croatian: Mogu se javiti omaglica uslijed pada krvnog tlaka ili nepravilni otkucaji srca, pospanost, umor ili neuobičajeni pokreti tijela te poteškoće sa stajanjem ili hodanjem.
English: Results for the primary outcome parameter are summarized in Table 1 below.
Croatian: U tablici 1 u nastavku, prikazani su sažeti rezultati parametara primarnog ishoda.
English: 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.
Croatian: Prema podacima iz kratkoročnih ispitivanja postojale su neznatno veće promjene srednje vrijednosti tjelesne težine u skupini liječenoj kariprazinom naspram skupine liječene placebom; 1 kg, odnosno 0,3 kg.
English: Cariprazine has low affinity for serotonin 5-HT2C and adrenergic α1 receptors (Ki values of 134 nM and 155 nM, respectively).
Croatian: Kariprazin ima nizak afinitet za serotoninske receptore 5-HT2C i adrenergičke receptore α1 (Ki:
English: QR code to be included www.reagila.com
Croatian: Umetnuti QR kod www.reagila.com
English: Alcohol should be avoided when taking Reagila.
Croatian: Tijekom liječenja lijekom Reagila treba izbjegavati alkohol.
English: Concomitant administration of strong or moderate CYP3A4 inhibitors (see section 4.5).
Croatian: Istodobna primjena jakih ili umjerenih inhibitora CYP3A4 (vidjeti dio 4.5).
English: - 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
Croatian: - osjećaj nemira i nemogućnost mirnog sjedenja - parkinsonizam - zdravstveno stanje praćeno mnoštvom različitih simptoma, koji uključuju smanjene ili usporene pokrete, usporene misli, iznenadno trzanje kod svijanja udova (zupčasta ukočenost), sitni koraci uz povlačenje nogu pri hodu, drhtanje, neznatna izražajnost lica ili bezizražajno lice, ukočenost mišića, slinjenje
English: Reagila 3 mg, 4.5 mg and 6 mg hard capsules contain Allura red AC (E 129), which may cause allergic reactions.
Croatian: Reagila tvrde kapsule od 3 mg, 4,5 mg i 6 mg sadrže boju Allura red AC (E 129), koja može uzrokovati alergijske reakcije.
English: Reagila 3 mg, 4.5 mg, 6 mg hard capsules contain Allura red AC (E129).
Croatian: Reagila 3 mg, 4,5 mg i 6 mg tvrde kapsule sadrže boju Allura red AC (E129).
English: In the negative symptom study EPS was reported in 14.3% in the cariprazine group and 11.7% in the risperidone treated patients.
Croatian: Prema podacima iz ispitivanja negativnih simptoma, EPS je prijavljen u 14,3% bolesnika iz skupine liječene kariprazinom, te u 11,7% bolesnika liječenih risperidonom.
English: 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.
Croatian: U bolesnika sa shizofrenijom je kod primjene kariprazina unutar terapijskog raspona doza tijekom 15 dana primijećena o dozi ovisna zauzetost moždanih dopaminskih receptora D3 i D2 (uz preferencijalnu zauzetost u regijama s većom ekspresijom D3).
English: LIST OF EXCIPIENTS Also contains Allura red AC (E129).
Croatian: POPIS POMOĆNIH TVARI Sadrži i boju Allura red AC (E129).
English: Cariprazine should be used with caution in patients with risk factors for stroke.
Croatian: Kariprazin treba primjenjivati uz oprez u bolesnika koji imaju čimbenike rizika za moždani udar.
English: A potentially fatal symptom complex referred to as neuroleptic malignant syndrome (NMS) has been reported in association with antipsychotic treatment.
Croatian: Kod liječenja antipsihoticima prijavljen je potencijalno smrtonosan skup simptoma pod nazivom neuroleptički maligni sindrom (NMS).
English: 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
Croatian: 2Akatizija: akatizija, psihomotorička hiperaktivnost, nemir 3Parkinsonizam: akinezija, bradikinezija, bradifrenija, „zupčasta ukočenost“, ekstrapiramidni poremećaj, poremećaj hoda, hipokinezija, ukočenost zglobova, tremor, hipomimija, mišićna ukočenost, mišićno-koštana ukočenost, ukočenost vrata, parkinsonizam
English: 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.
Croatian: Za koncentracije vezanih i nevezanih spojeva, ukupna izloženost (AUC i Cmax) aktivnim spojevima (CAR+DCAR+DDCAR) smanjena je za 21-22% u bolesnika s blagim, odnosno 13-15% u bolesnika s umjerenim oštećenjem funkcije jetre naspram zdravih ispitanika, dok je ukupna izloženost nevezanim spojevima smanjena za 12-13% u bolesnika s blagim, odnosno povećana za 20-25% u bolesnika s umjerenim oštećenjem funkcije jetre, nakon višetrukih doza kariprazina.
English: However, a statistically significant difference (p< 0.001) in favour of cariprazine over risperidone was observed from Week 10 onward (Table 2).
Croatian: Međutim, počevši od 10. tjedna uočena je statistički značajna razlika (p < 0,001) u korist kariprazina naspram risperidona (tablica 2).
English: How to take Reagila
Croatian: Kako uzimati lijek Reagila
English: 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
Croatian: 4Distonija: blefarospazam, distonija, mišićna napetost, oromandibularna distonija, tortikolis, trizmus 5Druge ekstrapiramidne bolesti i poremećaji koji se manifestiraju abnormalnim kretnjama: poremećaj ravnoteže, bruksizam, slinjenje, dizartrija, poremećaj hoda, abnormalan glabelarni refleks, hiporefleksija, poremećaj kretanja, sindrom nemirnih nogu, hipersekrecija sline, poremećaj pokreta jezika 6Diskinezija: koreoatetoza, diskinezija, grimase, okulogirna kriza, protruzija jezika
English: Therefore, co-administration of cariprazine with strong or moderate inhibitors of CYP3A4 (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole, diltiazem, erythromycin, fluconazole verapamil) is contraindicated (see section 4.3).
Croatian: Stoga je istodobna primjena kariprazina sa snažnim ili umjerenim inhibitorima CYP3A4 (npr. boceprevirom, klaritromicinom, kobicistatom, indinavirom, itrakonazolom, ketokonazolom, nefazodonom, nelfinavirom, posakonazolom, ritonavirom, sakvinavirom, telaprevirom, telitromicinom, vorikonazolom, diltiazemom, eritromicinom, flukonazolom, verapamilom) kontraindicirana (vidjeti dio 4.3).
English: In clinical trials, glucose-related adverse reactions have been reported with cariprazine (see section 5.1).
Croatian: U kliničkim su ispitivanjima kod primjene kariprazina prijavljene nuspojave povezane s glukozom (vidjeti dio 5.1).
English: - decreased or increased sexual desire, erectile problems - eye irritation, high pressure in the eye, poor vision - focusing problems seeing at a distance to or seeing close-to - low blood pressure - abnormal ECG reading, abnormal nerve impulses in the heart - slow, irregular heart rate - hiccups - heartburn - thirst - pain when passing urine - abnormally frequent and large urinations - itching, rash - diabetes - the following can be seen in laboratory tests:
Croatian: - smanjena ili povećana spolna želja, poteškoće s erekcijom - nadraženost oka, visok tlak u oku, oslabljen vid - problemi pri prebacivanju fokusa s gledanja na daljinu na gledanje na blizinu - nizak krvni tlak - odstupanja u nalazima EKG-a, abnormalno provođenje električnih impulsa u srcu - spori, nepravilni otkucaji srca - štucavica - žgaravica - žeđ - bol pri mokrenju - neuobičajeno česta i obilna mokrenja - svrbež, osip - šećerna bolest - sljedeće može biti viđeno u rezultatima laboratorijskih pretraga:
English: 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).
Croatian: Zabilježeno je statistički značajno poboljšanje i u skupini liječenoj kariprazinom i u skupini liječenoj risperidonom s obzirom na promjenu PANSS rezultata za negativne simptome (primarni parametar za djelotvornost) od početka ispitivanja (PANSS-FSNS) (p < 0,001).
English: - anxiety - sleepiness, difficulty in sleeping, abnormal dreams, nightmare, sleepwalking - dizziness - involuntary twisting movements and strange postures - excessive teeth grinding or jaw clenching, drooling, persistent blinking in response to tapping of the forehead (an abnormal reflex), movement problems, tongue movement disturbance (these are called extrapyramidal symptoms) - blurred vision - high blood pressure - fast, irregular heartbeat - decreased or increased appetite - nausea, vomiting, constipation - weight increased - tiredness - the following can be seen in laboratory tests:
Croatian: - tjeskoba - pospanost, poteškoće sa spavanjem, neuobičajeni snovi, noćne more, mjesečarenje - omaglica - nevoljni pokreti uvijanja i neobično držanje - prekomjerno škrgutanje zubima ili stiskanje čeljusti, slinjenje, ustrajno treptanje kao odgovor na lupkanje čela (abnormalan refleks), poteškoće s kretanjem, poremećaj pokreta jezika (ovi simptomi nazivaju se ekstrapiramidni simptomi) - zamagljen vid - visok krvni tlak - brzi, nepravilni otkucaji srca - smanjen ili povećan tek - mučnina, povraćanje, zatvor - povećanje tjelesne težine - umor - sljedeće može biti viđeno u rezultatima laboratorijskih pretraga:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Reagila 1.5 mg hard capsules
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Reagila 1,5 mg tvrde kapsule
English: Unchanged cariprazine is excreted by 1.2% of the dose in urine and 3.7% of the dose in feces.
Croatian: 1,2% doze kariprazina izlučuje se u neizmijenjenu obliku kroz mokraću, dok se 3,7% doze izlučuje kroz feces.
English: 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.
Croatian: Prema podacima kliničkih ispitivanja kariprazina incidencija nuspojava u vidu povišenih vrijednosti ALT-a, AST-a javila se u 2,2% bolesnika liječenih kariprazinom, 1,6% bolesnika liječenih risperidonom i 0,4% bolesnika liječenih placebom.
English: Ocular symptoms/cataract
Croatian: Očni simptomi/katarakta
English: Patients should be monitored for adverse reactions and treatment response for several weeks after starting cariprazine and after each dosage change (see section 5.2).
Croatian: Nakon uvođenja kariprazina i nakon svake promjene doze bolesnici moraju biti pod nadzorom zbog nuspojava i praćenja odgovora na liječenje tijekom nekoliko tjedana (vidjeti dio 5.2).
English: Magyarország
Croatian: MAĐARSKA
English: 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.
Croatian: Primijećena je hipertrofija kore nadbubrežne žlijezde u štakora (samo kod ženki) pri razini izloženosti koja je bila 4,1 puta veća od kliničke izloženosti pri maksimalnoj preporučenoj dozi za ljude, dok je u miševa isto zabilježeno pri klinički značajnim plazmatskim koncentracijama ukupnog kariprazina.
English: If you are using hormonal contraceptives a so-called barrier method(e.g. condom or diaphragm) should also be used.
Croatian: Ako koristite hormonske kontraceptive, trebate koristiti i takozvanu mehaničku metodu kontracepcije (npr. kondome ili dijafragmu).
English: DCAR is further metabolized by CYP3A4 and to a lesser extent by CYP2D6 into DDCAR and HDCAR.
Croatian: DCAR se dalje metabolizira putem CYP3A4, i u manjoj mjeri putem CYP2D6, u DDCAR i HDCAR.
English: No effects on male fertility were noted at exposures up to 4.8 times the clinical exposure at the MRHD.
Croatian: Nisu zabilježeni učinci na plodnost mužjaka pri izloženosti do 4,8 puta većoj od kliničke izloženosti pri maksimalnoj preporučenoj dozi za ljude.
English: Women of childbearing potential must use highly effective contraception while taking Reagila and for at least 10 weeks after stopping treatment.
Croatian: Žene u reproduktivnoj dobi moraju koristiti visoko učinkovitu kontracepciju tijekom uzimanja lijeka Reagila te najmanje još 10 tjedana nakon prekida liječenja.
English: 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.
Croatian: U randomiziranim, placebom kontroliranim kliničkim ispitivanjima, kod primjene nekih atipičnih antipsihotika u populaciji bolesnika s demencijom primijećen je približno 3 puta veći rizik od cerebrovaskularnih nuspojava.
English: Akathisia was reported in 10.0% in patients treated with cariprazine and 5.2% in the risperidone group.
Croatian: Akatizija je prijavljena u 10,0% bolesnika liječenih kariprazinom, te u 5,2% bolesnika iz skupine liječene risperidonom.
English: However, a statistically significant difference (p=0.002) in favour of cariprazine over risperidone was observed from Week 14 onward (Table 2).
Croatian: Međutim, počevši od 14. tjedna, zabilježena je statistički značajna razlika (p = 0,002) u korist kariprazina naspram risperidona (tablica 2).
English: Electrocardiog ram QT prolonged Electrocardiog ram T wave abnormal
Croatian: T-val na elektrokardiog ramu
English: Akathisia was reported in 3.9% in patients treated with cariprazine, versus 2.0% in the placebo group.
Croatian: Akatizija je prijavljena u 3,9% bolesnika iz skupine liječene kariprazinom u usporedbi s 2,0% bolesnika liječenih placebom.
English: Akathisia, restlessness
Croatian: Akatizija, nemir
English: Reagila 4.5 mg and Reagila 6 mg hard capsules are available in pack sizes containing 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Croatian: Reagila 4,5 mg i Reagila 6 mg tvrde kapsule dostupne su u pakiranjima koja sadrže 21, 28, 30, 49, 56, 60, 84, 90 ili 98 tvrdih kapsula.
English: In the short term studies the incidence of EPS was observed in 27%; 11.5%; 30.7% and 15.1% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively.
Croatian: Prema podacima iz kratkoročnih ispitivanja, incidencija EPS-a opažena je u 27%, 11,5%, 30,7% i 15,1% bolesnika liječenih kariprazinom, placebom, risperidonom, odnosno aripiprazolom.
English: Development of cataracts was observed in cariprazine non-clinical studies (see section 5.3).
Croatian: U nekliničkim ispitivanjima kariprazina opažen je razvoj katarakte (vidjeti dio 5.3).