FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Reagila 1,5 mg i Reagila 3 mg tvrde kapsule dostupne su u pakiranjima koja sadrže 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 ili 98 tvrdih kapsula.
English: 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.
Croatian: Prema podacima iz trećeg multinacionalnog, placebom kontroliranog ispitivanja primjene fiksnih/fleksibilnih doza kariprazina od 3,0 do 6,0 mg i kariprazina od 6,0 do 9,0 mg, obje skupine liječene navedenim dozama kariprazina pokazale su statistički značajno poboljšanje mjera i primarnog i sekundarnog ishoda naspram placeba.
English: Elevated liver transaminases (ALT, AST) are frequently observed with antipsychotic treatment.
Croatian: Kod liječenja antipsihoticima često se primijećuju povišene vrijednosti jetrenih transaminaza (ALT, AST).
English: Cariprazine has not been evaluated in patients with severe hepatic impairment (Child-Pugh Class C) (see section 4.2).
Croatian: Kariprazin se nije ocjenjivao u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) (vidjeti dio 4.2).
English: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotics - Frequency unknown.
Croatian: Kod primjene antipsihotika prijavljeni su slučajevi venske tromboembolije, uključujući slučajeve plućne embolije i slučajeve duboke venske tromboze.
English: 1Sleep disorders: Insomnia, Abnormal dreams/nightmare, Circadian rhythm sleep disorder, Dyssomnia, Hypersomnia, Initial insomnia, Middle insomnia, Nightmare, Sleep disorder, Somnambulism, Terminal insomnia
Croatian: 1Poremećaji spavanja: nesanica, abnormalni snovi/noćne more, poremećaj cirkadijanog ritma spavanja, disomnija, hipersomnija, poteškoće s usnivanjem, poteškoće održavanja spavanja, noćne more, poremećaj spavanja, mjesečarenje, ranojutarnje buđenje
English: (Side effect with frequency not known) - thoughts or feelings about hurting yourself or to commit suicide, suicide attempt.
Croatian: (Nuspojava nepoznate učestalosti) - misli o samoozljeđivanju ili osjećate da biste si mogli nauditi ili počiniti samoubojstvo, ili ste pokušali samoubojstvo. (Manje česta nuspojava)
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog pruritus osip
English: 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%).
Croatian: Tijekom perioda dvostruko slijepog liječenja, povećanje od ˃ 60 ms za QTcB u odnosu na vrijednosti s početka liječenja uočeno je u 3 bolesnika (3,1%) liječenih kariprazinom te u 2 bolesnika (2%) liječenih placebom.
English: Weight change
Croatian: Promjena tjelesne težine
English: In clinical trials, only a few, non-serious, QTprolongations have been reported with cariprazine (see section 4.8).
Croatian: U kliničkim ispitivanjima kariprazin je uzrokovao svega nekoliko produljenja QT intervala, a ista nisu bila ozbiljna (vidjeti dio 4.8).
English: Weight changes
Croatian: Promjene tjelesne težine
English: 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.
Croatian: Positive and Negative Syndrome Scale, PANSS), a mjera sekundarnog ishoda bila je promjena od početne vrijednosti do kraja 6. tjedna u ukupnom rezultatu na ocjenskoj ljestvici općeg kliničkog dojma težine bolesti (engl.
English: In rat studies lower female fertility and conception indices were observed (see section 5.3).
Croatian: U ispitivanjima na štakorima primijećeni su niži indeksi plodnosti i začeća u ženki (vidjeti dio 5.3).
English: 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.
Croatian: Prema podacima iz ispitivanja dugotrajnog održavanja učinkovitosti, tijekom otvorene faze uočeno je povećanje od ˃ 60 ms u 12 bolesnika (1,6%) za QTcB te u 4 bolesnika (0,5%) za QTcF u odnosu na vrijednosti s početka liječenja.
English: Signs of high blood sugar level are excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak.
Croatian: Znakovi povišene razine šećera u krvi jesu pretjerana žeđ, obilno mokrenje, pojačani tek i osjećaj slabosti. - ako imate napadaje ili epilepsiju u povijesti bolesti.
English: Cartons contain 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Croatian: Kutija sadrži 21, 28, 30, 49, 56, 60, 84, 90 ili 98 tvrdih kapsula.
English: Rare (≥1/10,000 to
Croatian: Rijetko (≥ 1/10 000 i
English: Adverse drug reactions (ADRs) based upon pooled data from cariprazine schizophrenia studies are shown by system organ class and by preferred term.
Croatian: Nuspojave lijeka utemeljene na objedinjenim podacima iz ispitivanja kariprazina u liječenju shizofrenije prikazane su prema organskim sustavima i preporučenim pojmovima.
English: 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.
Croatian: Pri klinički značajnim razinama izloženosti opažena je fosfolipidoza u plućima štakora, pasa i miševa (praćena upalom ili bez nje) te u kori nadbubrežne žlijezde pasa.
English: 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.
Croatian: Relaps simptoma shizofrenije je do kraja ispitivanja doživjelo 49,0% bolesnika koji su primali placebo naspram 21,6% bolesnika liječenih kariprazinom.
English: Seizures/ Convulsion Amnesia Aphasia
Croatian: tardivna diskinezija konvulzije amnezija afazija maligni sindrom
English: Parkinsonism was experienced in 13.6%; 5.7%; 22.1% and 5.3% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively.
Croatian: Parkinsonizam je iskusilo 13,6%, 5,7%, 22,1% i 5,3% bolesnika liječenih kariprazinom, placebom, risperidonom odnosno aripiprazolom.
English: 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.
Croatian: Prema podacima iz multinacionalnog, placebom kontroliranog ispitivanja primjene fiksnih doza kariprazina od 1,5 mg, 3,0 mg i 4,5 mg i risperidona od 4,0 mg radi ocjene osjetljivosti testa, sve primijenjenje doze kariprazina i aktivnog kontrolnog lijeka pokazale su statistički značajno poboljšanje mjera i primarnog i sekundarnog ishoda naspram placeba.
English: Cartons contain 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Croatian: Kutija sadrži 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 ili 98 tvrdih kapsula.
English: Akathisia was reported in 13.6%; 5.1%; 9.3% and 9.9% in patients treated with cariprazine, placebo, risperidone and aripiprazole respectively.
Croatian: Akatizija je prijavljena u 13,6%, 5,1%, 9,3% i 9,9% bolesnika liječenih kariprazinom, placebom, risperidonom, odnosno aripiprazolom.
English: 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).
Croatian: Kariprazin i njegovi glavni aktivni metaboliti nisu supstrati P-glikoproteina (P-gp), polipeptidnih prijenosnika organskih aniona 1B1 i 1B3 (OATP1B1 i OATP1B3) ni proteina rezistencije raka dojke (BCRP), što ukazuje na to da interakcija kariprazina s inhibitorima P-gp-a, prijenosnika OATP1B1 i OATP1B3 te BCRP-a nije vjerojatna.
English: However, a causal relationship between lenticular changes / cataracts observed in human studies and cariprazine use has not been established.
Croatian: Međutim, u ispitivanjima primjene lijeka kod ljudi, nije utvrđena uzročno-posljedična veza između pojave lentikularnih promjena/katarakte i primjene kariprazina.
English: How to store Reagila
Croatian: Kako čuvati lijek Reagila
English: Reagila 1.5 mg and Reagila 3 mg hard capsules
Croatian: Reagila 1,5 mg i Reagila 3 mg tvrde kapsule
English: In other clinical trials, only a few, non-serious, QT-prolongations have been reported with cariprazine.
Croatian: U drugim kliničkim ispitivanjima kariprazin je uzrokovao svega nekoliko produljenja QT intervala, a ista nisu bila ozbiljna.
English: In female rats, lower fertility and conception indices were observed at clinically relevant exposures based on mg/m2 body surface area.
Croatian: U ženki štakora su pri klinički značajnim razinama izloženosti na temelju površine tijela izražene u mg/m primijećeni niži indeksi plodnosti i začeća.
English: Cariprazine 3 mg/day 96.1 ± 8.7 -20.2 (1.5) Cariprazine 6 mg/day 95.7 ± 9.4 -23.0 (1.5) Aripiprazole 10 mg/day 95.6 ± 9.0 -21.2 (1.4) RGH-MD-05 (n=439)
Croatian: Aripiprazol 10 mg/dan 95,6 ± 9,0 -21,2 (1,4) RGH-MD-05 (n = 439)
English: Weigth increase
Croatian: Povećanje tjelesne težine
English: Dystonia was observed in 1.8%; 0.2%; 3.6% and 0.7% in patients on cariprazine, placebo, risperidone and aripiprazole, respectively.
Croatian: Distonija je opažena u 1,8%, 0,2% 3,6% i 0,7% bolesnika liječenih kariprazinom, placebom, risperidonom odnosno aripiprazolom.
English: 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.
Croatian: Prema podacima iz drugog multinacionalnog, placebom kontroliranog ispitivanja primjene fiksnih doza kariprazina od 3,0 mg i 6,0 mg i aripiprazola od 10,0 mg radi ocjene osjetljivosti testa, obje primijenjenje doze kariprazina i aktivnog kontrolnog lijeka pokazale su statistički značajno poboljšanje mjera i primarnog i sekundarnog ishoda naspram placeba.
English: Reagila 1.5 mg hard capsules Reagila 3 mg hard capsules Reagila 4.5 mg hard capsules Reagila 6 mg hard capsules cariprazine
Croatian: Reagila 1,5 mg tvrde kapsule Reagila 3 mg tvrde kapsule Reagila 4,5 mg tvrde kapsule Reagila 6 mg tvrde kapsule kariprazin
English: Reagila 4.5 mg and Reagila 6 mg hard capsules
Croatian: Reagila 4,5 mg i Reagila 6 mg tvrde kapsule
English: - 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)
Croatian: Nemojte uzimati lijek Reagila: - ako ste alergični na kariprazin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako uzimate lijekove koji se koriste za liječenje: hepatitisa C (lijekovi koji sadrže boceprevir i telaprevir) bakterijskih infekcija (lijekovi koji sadrže klaritromicin, telitromicin, eritromicin i nafcillin) tuberkuloze (lijekovi koji sadrže rifampicin)
English: Cases of venous thromboembolism have been reported with antipsychotic medicinal products.
Croatian: Kod primjene antipsihotika prijavljeni su slučajevi venske tromboembolije.
English: 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.
Croatian: Tijekom perioda dugotrajnog, otvorenog liječenja, 3 bolesnika (0,4%) imalo je QTcB ˃ 500 ms, od kojih je jedan također imao QTcF ˃ 500 ms.
English: INFORMATION IN BRAILLE reagila 1.5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU reagila 1,5 mg
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava anemija eozinofilija neutropenija
English: Recordati AB Tel: +46 8 545 80 230
Croatian: Tel: +46 8 545 80 230
English: Use of cariprazine is not recommended in patients with severe hepatic impairment (see section 5.2).
Croatian: Primjena kariprazina ne preporučuje se u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dio 5.2).
English: INFORMATION IN BRAILLE reagila 6 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU reagila 6 mg
English: Close supervision of high-risk patients should accompany antipsychotic therapy.
Croatian: Visokorizične bolesnike koji se liječe antipsihoticima potrebno je strogo nadzirati.
English: Use of cariprazine is not recommended in patients with severe renal impairment (see section 5.2).
Croatian: Primjena kariprazina ne preporučuje se u bolesnika s teškim oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: Lens opacity/Cataract
Croatian: Neprozirnost leće/katarakta
English: INFORMATION IN BRAILLE reagila 4.5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU reagila 4,5 mg
English: Reagila 1.5 mg hard capsules Reagila 3 mg hard capsules Reagila 4.5 mg hard capsules Reagila 6 mg hard capsules
Croatian: Reagila 1,5 mg tvrde kapsule Reagila 3 mg tvrde kapsule Reagila 4,5 mg tvrde kapsule Reagila 6 mg tvrde kapsule
English: Reagila 6 mg hard capsules
Croatian: Reagila 6 mg tvrde kapsule
English: Gastrooesopha geal reflux disease
Croatian: Poremećaji probavnog sustava mučnina konstipacija povraćanje gastroezofagus na refluksna bolest disfagija
English: After discontinuation of cariprazine treatment contraception should be used for at least 10 weeks due to the slow elimination of active moieties.
Croatian: Zbog spore eliminacije aktivnih spojeva potrebno je koristiti kontracepciju najmanje još 10 tjedana nakon prekida liječenja kariprazinom.
English: Efficacy in predominantly negative symptoms of schizophrenia The efficacy of cariprazine for the treatment of predominantly negative symptoms of schizophrenia was investigated in a 26-week, multi-centre, double-blind, and active-controlled clinical trial.
Croatian: U 26-tjednom multicentričnom, dvostruko slijepom, aktivnim lijekom kontroliranom kliničkom ispitivanju ispitivala se djelotvornost kariprazina u liječenju predominantno negativnih simptoma shizofrenije.
English: INFORMATION IN BRAILLE reagila 3 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU reagila 3 mg
English: Reagila 4.5 mg hard capsules
Croatian: Reagila 4,5 mg tvrde kapsule
English: Reagila 3 mg hard capsules
Croatian: Reagila 3 mg tvrde kapsule
English: Recordati BVBA Tel: + 32 2 46101 36 (België)
Croatian: Tel: + 32 2 46101 36 (België)
English: With cariprazine no QT interval prolongation was detected compared to placebo in a clinical trial designed to assess QT prolongation (see section 5.1).
Croatian: U kliničkom ispitivanju dizajniranom da procijeni učinak liječenja na produljenje QT intervala, kariprazin nije uzrokovao produljenje QT intervala u odnosu na placebo (vidjeti dio 5.1).
English: Cariprazine is metabolized by CYP3A4 and, to a lesser extent, by CYP2D6, to DCAR and HCAR.
Croatian: Kariprazin se metabolizira putem CYP3A4, i u manjoj mjeri putem CYP2D6, u DCAR i HCAR.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Gedeon Richter Plc.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Gedeon Richter Plc.
English: Reagila 1.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Croatian: Reagila 1,5 mg: jedna tvrda kapsula sadrži 1,5 mg kariprazina u obliku kariprazinklorida.
English: Vision blurred Eye irritation Intraocular pressure increased
Croatian: Poremećaji oka zamagljen vid iritacija oka povišen intraokularni tlak poremećaj akomodacije oka smanjena oštrina vida fotofobija katarakta
English: Neuroleptic malignant syndrome extrapyramidal diseases and abnormal movement disorders5
Croatian: Nepoznata učestalost živčanog sustava parkinsonizam omaglica distonija4 druge ekstrapiramidn e bolesti i poremećaji koji se manifestiraju abnormalnim kretnjama5
English: 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)
Croatian: Kariprazin 4,5 mg/dan 96,7 ± 9,01 -23,77 (1,74) -10,48 (-15,41, -5,55) < 0,0001 Risperidon 4 mg/dan
English: Hiccups
Croatian: Štucavica
English: Uncommon (≥1/1,000 to
Croatian: Manje često (≥ 1/1000 i
English: Tel.: + 48 (22)755 96 48
Croatian: GEDEON RICHTER POLSKA Sp. z o.o. Tel.: + 48 (22)755 96 48
English: Reagila 4.5 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine.
Croatian: Reagila 4,5 mg: jedna tvrda kapsula sadrži 4,5 mg kariprazina u obliku kariprazinklorida.
English: Gedeon Richter Slovakia, s.r.o.
Croatian: Gedeon Richter România S.A.
English: Total PSP at Baseline Total PSP at Week 26 Total PSP CfB to Week 26 CfB= change from baseline
Croatian: Ukupni rezultat na ljestvici PSP u 26. tjednu
English: Allura red AC (E 129) Brilliant blue FCF (E 133) Titanium dioxide (E 171) Yellow iron oxide (E 172) Gelatin
Croatian: Allura red AC (E 129) titanijev dioksid (E 171) želatina
English: Parkinsonism was experienced in 7.8% and 1.0% in cariprazine and placebo group respectively.
Croatian: Parkinsonizam je iskusilo 7,8% bolesnika iz skupine liječene kariprazinom, odnosno 1,0% bolesnika liječenih placebom.
English: ° decreased level of thyroid stimulating hormone (TSH) in the blood
Croatian: ° anemija (smanjen broj crvenih krvnih stanica) ° povećan broj jedne vrste bijelih krvnih stanica ° snižena razina hormona koji stimulira štitnjaču (TSH) u krvi
English: Parkinsonism was experienced in 5.2% and 7.4% in cariprazine and risperidone treated patients respectively.
Croatian: Parkinsonizam je iskusilo 5,2% bolesnika iz skupine liječene kariprazinom, odnosno 7,4% bolesnika iz skupine liječene risperidonom.
English: Reagila 6 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine.
Croatian: Reagila 6 mg: jedna tvrda kapsula sadrži 6 mg kariprazina u obliku kariprazinklorida.
English: Reagila 3 mg: Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine.
Croatian: Reagila 3 mg: jedna tvrda kapsula sadrži 3 mg kariprazina u obliku kariprazinklorida.
English: NAME OF THE MEDICINAL PRODUCT Reagila 1.5 mg hard capsules cariprazine
Croatian: NAZIV LIJEKA Reagila 1,5 mg tvrde kapsule kariprazin
English: Dysuria Pollakisuria
Croatian: Prijavljivanje nuspojava
English: QT- prolongation
Croatian: Produljenje QT intervala
English: Each hard capsule contains 0.0096 mg Allura red AC (E 129).
Croatian: Jedna tvrda kapsula sadrži 0,0096 mg boje Allura red AC (E 129).
English: Printing ink (black: 1.5 mg, 3 mg and 6 mg capsules)
Croatian: Tinta za označavanje (crna: kapsule od 1,5 mg, 3 mg i 6 mg) šelak željezov oksid, crni (E 172) propilenglikol kalijev hidroksid
English: NAME OF THE MEDICINAL PRODUCT Reagila 6 mg hard capsules cariprazine
Croatian: NAZIV LIJEKA Reagila 6 mg tvrde kapsule kariprazin
English: Each hard capsule contains 0.0008 mg Allura red AC (E 129).
Croatian: Jedna tvrda kapsula sadrži 0,0008 mg boje Allura red AC (E 129).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Gedeon Richter Plc.
English: Increased incidence of retinal degeneration/atrophy was observed in albino rats in the 2-year study at clinically relevant exposures.
Croatian: 2godišnjem je ispitivanju pri klinički značajnim razinama izloženosti opažena povećana incidencija degeneracije/atrofije mrežnice u albino štakora.
English: NAME OF THE MEDICINAL PRODUCT Reagila 4.5 mg hard capsules cariprazine
Croatian: NAZIV LIJEKA Reagila 4,5 mg tvrde kapsule kariprazin
English: NAME OF THE MEDICINAL PRODUCT Reagila 3 mg hard capsules cariprazine
Croatian: NAZIV LIJEKA Reagila 3 mg tvrde kapsule kariprazin
English: Lethargy Dysaesthesia Dyskinesia6 Tardive
Croatian: dizestezija diskinezija6
English: 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).
Croatian: I u skupini liječenoj kariprazinom i u skupini liječenoj risperidonom uočeno je statistički značajno poboljšanje s obzirom na promjenu ukupnog rezultata za osobno i društveno funkcioniranje (engl.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/029-036
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1209/029-036
English: ° abnormal sodium level in the blood
Croatian: ° odstupanja vrijednosti natrija u krvi
English: Each hard capsule contains 0.0003 mg Allura red AC (E 129).
Croatian: Jedna tvrda kapsula sadrži 0,0003 mg boje Allura red AC (E 129).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 1,5 mg kariprazina u obliku kariprazinklorida.
English: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Croatian: Jedna tvrda kapsula sadrži 1,5 mg kariprazina u obliku kariprazinklorida.
English: as well as PANSS-FSNS response rates (PANSS FSNS ≥ 30% improvement at Week 26; p= 0.003)
Croatian: Razlike u rezultatima na ocjenskim ljestvicama općeg kliničkog dojma težine (p = 0,005) i poboljšanja (p < 0,001) bolesti, kao i u stopama odgovora mjerenih ljestvicom PANSS-FSNS (PANSS-FSNS ≥ 30% poboljšanja u 26. tjednu; p = 0,003) išle su u prilog zaključcima temeljenim na primarnim i sekundarnim parametrima za djelotvornost.
English: - Reagila 4.5 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink.
Croatian: - Reagila 4,5 mg tvrde kapsule: Tvrda želatinska kapsula veličine „4“ (približne duljine 14,3 mm) s neprozirnom zelenom kapicom i neprozirnim zelenim tijelom te oznakom „GR 4.5“ otisnutom bijelom tintom na tijelu kapsule.
English: QT prolongation can develop in patients treated with antipsychotics.
Croatian: U bolesnika liječenih antipsihoticima može doći do produljenja QT intervala.
English: - Reagila 1.5 mg hard capsules: ‘Size 4' (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink.
Croatian: - Reagila 1,5 mg tvrde kapsule: Tvrda želatinska kapsula veličine „4“ (približne duljine 14,3 mm) s neprozirnom bijelom kapicom i neprozirnim bijelim tijelom te oznakom „GR 1.5“ otisnutom crnom tintom na tijelu kapsule.
English: Tel: + +386 8 205 68 70
Croatian: Gedeon Richter d.o.o. Tel: + +386 8 205 68 70
English: Significant weight gain has been observed with the use of cariprazine.
Croatian: Kod primjene kariprazina primijećeno je značajno povećanje tjelesne težine.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/011-020
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1209/011-020
English: Titanium dioxide (E 171) Propylene glycol Simeticone
Croatian: Tinta za označavanje (bijela: kapsule od 4,5 mg) šelak titanijev dioksid (E 171) propilenglikol simetikon
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1209/021-028
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1209/021-028