FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with moderate to severe hepatic impairment (Child-Pugh Classes B and C), the maximum recommended dose is reduced to 3 mg once daily (see section 4.2).
Croatian: U bolesnika s umjerenim do teškim oštećenjem jetre (Child-Pugh stadiji B i C), maksimalna preporučena doza snižena je na 3 mg jedanput dnevno (vidjeti dio 4.2).
English: In subjects (n = 22) with varying degrees of hepatic impairment (Child-Pugh Classes A, B, and C), the AUC of oral brexpiprazole (2 mg single dose), compared to matched healthy subjects, increased 24 % in mild hepatic impairment, increased 60 % in moderate hepatic impairment, and did not change in severe hepatic impairment.
Croatian: AUC peroralnog brekspiprazola (jedne doze od 2 mg) u ispitanika (n = 22) s raznim stupnjevima oštećenja funkcije jetre (Child-Pugh stadiji A, B, i C) u usporedbi s odgovarajućim zdravim ispitanicima bio je povećan za 24 % kod blagog oštećenja funkcije jetre i 60 % kod umjerenog oštećenja funkcije jetre, dok se kod teškog oštećenja jetre nije promijenio.
English: Close supervision of high-risk patients should accompany antipsychotic treatment.
Croatian: Visokorizične bolesnike koji se liječe antipsihoticima potrebno je strogo nadzirati.
English: Once daily dosing while CYP3A4 inducers are administered results in high peak to trough fluctuation, hence twice daily divided dosing is preferable.
Croatian: Doziranje jedanput dnevno dok se primjenjuju induktori CYP3A4 dovodi do velikih fluktuacija između vršnih i najnižih vrijednosti pa je stoga bolje podijeliti dozu i primijeniti je dvaput dnevno.
English: RXULTI contains lactose
Croatian: RXULTI sadrži laktozu
English: The effects of brexpiprazole were also evaluated across a number of pre-specified secondary endpoints; the specific aspects of symptoms of schizophrenia (PANSS Positive Subscale score, PANSS Negative Subscale score, PANSS Excited Component [PEC] score, PANSS Marder factors positive, negative, disorganised thoughts, uncontrolled hostility/excitement and anxiety/depression), and analyses of response (defined as 30 % improvement in PANSS total score compared to baseline or a CGI-I score of 1 [very much improved] or 2 [much improved]).
Croatian: PANSS Marder factors] pozitivni, negativni, neorganizirane misli, nekontrolirano neprijateljsko ponašanje/uzbuđenje i tjeskoba/depresija), i analize odgovora (definirane kao 30 %-tno poboljšanje ukupnog rezultata na ljestvici PANSS u usporedbi s početnim ili rezultat CGI-I od 1 [jako veliko poboljšanje] ili 2 [veliko poboljšanje]).
English: Patients taking strong CYP3A4 inducers
Croatian: Bolesnici koji uzimaju jake induktore CYP3A4
English: Otsuka Pharmaceutical Italy S.r.l.
Croatian: Otsuka Pharmaceuticals (UK) Ltd.
English: Brexpiprazole administered orally did not increase in the incidence of tumours in 2-year carcinogenicity study in both male and female rats and in male mice at exposures up to 4.4-fold and 3.1-fold the MRHD.
Croatian: Peroralno primijenjen brekspiprazol nije povećao incidenciju tumora u dvogodišnjem ispitivanju kancerogenosti u mužjaka i ženki štakora i mužjaka miša pri izloženosti do
English: A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotics.
Croatian: U bolesnika liječenih antipsihoticima može se razviti sindrom potencijalno ireverzibilnih, nevoljnih diskinetičkih pokreta.
English: If brexpiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used.
Croatian: Potreban je oprez ako se brekspiprazol primjenjuje istodobno s lijekovima za koje je utvrđeno da uzrokuju produljenje QT-intervala ili neravnotežu elektrolita.
English: Leukopenia, neutropenia and agranulocytosis (including fatal cases) have been reported during treatment with antipsychotics.
Croatian: Tijekom liječenja antipsihoticima zabilježene su leukopenija, neutropenija i agranulocitoza (uključujući smrtne slučajeve).
English: Dose adjustments should be made in patients taking concomitant strong CYP3A4 inhibitors/inducers or strong CYP2D6 inhibitors.
Croatian: Dozu je potrebno prilagoditi u bolesnika koji istodobno uzimaju jake inhibitore/induktore CYP3A4 ili jake inhibitore CYP2D6.
English: In clinical trials, only a few, nonserious, QT prolongations have been reported with brexpiprazole.
Croatian: U kliničkim je ispitivanjima zabilježeno svega nekoliko slučajeva produljenja QT-intervala uz brekspiprazol, koji nisu bili ozbiljni.
English: Tell your doctor if this happens.
Croatian: Ako se to dogodi, obratite se liječniku.
English: Patients with kidney problems
Croatian: Bolesnici koji imaju probleme s bubrezima
English: RXULTI 0.25 mg film-coated tablets RXULTI 0.5 mg film-coated tablets RXULTI 1 mg film-coated tablets RXULTI 2 mg film-coated tablets RXULTI 3 mg film-coated tablets RXULTI 4 mg film-coated tablets
Croatian: RXULTI 0,25 mg filmom obložene tablete RXULTI 0,5 mg filmom obložene tablete RXULTI 1 mg filmom obložene tablete RXULTI 2 mg filmom obložene tablete RXULTI 3 mg filmom obložene tablete RXULTI 4 mg filmom obložene tablete brekspiprazol
English: The maximum recommended dose in patients with moderate to severe impaired renal function is reduced to 3 mg once daily (see section 5.2).
Croatian: Oštećenje funkcije bubrega Maksimalna preporučena doza u bolesnika s umjerenim do teškim oštećenjem funkcije bubrega snižena je na 3 mg jedanput dnevno (vidjeti dio 5.2).
English: A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic treatment.
Croatian: Povezano s antipsihotičkim liječenjem zabilježen je potencijalno smrtonosan kompleks simptoma koji se naziva maligni neuroleptični sindrom (MNS).
English: The LS Mean, 95 % CI, and p-values for individual trials were derived from an MMRM (Mixed effect Model Repeat Measurement) analysis as follows: fixed effects of site, treatment, visit, and treatment-by-visit interaction, with baseline and baseline-by-visit interaction as covariates.
Croatian: Mixed effect Model Repeat Measurement, MMRM) na sljedeći način: fiksni učinci interakcije mjesta, liječenja, dolaska i liječenja po dolasku, uz interakciju početnih vrijednosti i početnih vrijednosti po dolasku kao kovarijate.
English: • during blood tests your doctor may find increases in liver enzymes.
Croatian: • na krvnim pretragama, liječnik Vam može pronaći veće količine triglicerida u krvi • na krvnim pretragama, liječnik Vam može pronaći povećane razine jetrenih enzima.
English: Based on in vivo studies, brexpiprazole is neither a substrate nor an inhibitor of efflux transporters, such as Multi Drug Resistance (MDR) 1 (P-gp) and BCRP.
Croatian: Na temelju ispitivanja in vivo, brekspiprazol nije ni supstrat niti inhibitor efluksnih prijenosnika poput prijenosnika za rezistenciju na više lijekova (engl.
English: In the brexpiprazole 4 mg/day group, the maximum placebo-adjusted mean change from baseline in the QTcl interval was 5.2 ms (90 % Cl: 1.5, 8.9) in males (n = 48) and 15.0 ms (90 % Cl: 7.7., 22.3) in females (n = 14) at 6 hours post-dosing.
Croatian: (90 % CI: 1,5; 8,9) u muškaraca (n = 48) i 15,0 ms (90 % CI: 7,7, 22,3) u žena (n = 14) 6 sati nakon primjene doze.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE
English: Delayed growth, physical development and impaired viability of the offspring were observed at maternally toxic brexpiprazole doses in a pre-/post-natal developmental toxicity study in orally administered rats.
Croatian: U ispitivanju prenatalne/postnatalne razvojne toksičnosti u kojem se brekspiprazol peroralno primjenjivao štakorima opaženi su zastoj u rastu i fizičkom razvoju te narušena vijabilnost potomstva pri dozama brekspiprazola toksičnima za majku.
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj
English: QT prolongation
Croatian: Produljenje QT-intervala
English: • irregularities in heart rhythm that may be due to abnormal nerve impulses in the heart, abnormal readings during heart examination (ECG), QT prolongation - it is not known how many people are affected.
Croatian: nepravilan nalaz na pregledu srca (EKG), produljenje QT-intervala - nije poznato u koliko ljudi se pojavljuje.
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane povećanje tjelesne težine
English: Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics.
Croatian: U bolesnika liječenih atipičnim antipsihoticima zabilježena je hiperglikemija, u nekim slučajevima krajnje visoka i povezana s ketoacidozom ili hiperosmolarnom komom ili smrću.
English: Oral activated charcoal and sorbitol (50 g/240 mL), administered one hour after ingesting 2 mg oral dose of brexpiprazole, decreased brexpiprazole Cmax and AUC by approximately 5 % to 23 % and 31 % to 39 % respectively; however, there is insufficient information available on the therapeutic potential of activated charcoal in treating an overdose with brexpiprazole.
Croatian: Peroralni aktivni ugljen i sorbitol (50 g/240 ml) primijenjeni jedan sat nakon uzimanja peroralne doze brekspiprazola od 2 mg smanjili su Cmax i AUC brekspiprazola za približno 5 % do 23 % odnosno
English: Strong/moderate CYP2D6 inhibitors with strong/moderate CYP3A4 inhibitors
Croatian: Jaki/umjereno jaki inhibitori CYP2D6 s jakim/umjereno jakim inhibitorima CYP3A4
English: Parkinsonism Seizures Neuroleptic malignant syndrome (NMS)
Croatian: Poremećaji živčanog sustava akatizija omaglica tremor sedacija parkinsonizam napadaji maligni neuroleptički sindrom (MNS)
English: • The active substance is brexpiprazole.
Croatian: • Djelatna tvar je brekspiprazol.
English: Further dosing modifications to a quarter of the recommended dose is required for known CYP2D6 poor metabolisers while taking strong or moderate CYP3A4 inhibitors (see sections 4.5 and 5.2).
Croatian: Daljnje prilagodbe doze na četvrtinu preporučene doze potrebne su kod utvrđeno sporih metabolizatora CYP2D6 dok uzimaju jake ili umjereno jake inhibitore CYP3A4
English: • antidepressants or herbal remedies used to treat depression and anxiety (such as fluoxetine,
Croatian: • lijekove za regulaciju srčanog ritma (kao što je kinidin), • antidepresive ili biljne lijekove koji se primjenjuju za liječenje depresije i tjeskobe (kao što su fluoksetin, paroksetin, gospina trava),
English: Based on studies utilising human liver enzymes in vitro, brexpiprazole is not a substrate for CYP1A2; smoking should, therefore, not have an effect on the pharmacokinetics of brexpiprazole.
Croatian: Na temelju ispitivanja pomoću enzima ljudske jetre in vitro, brekspiprazol nije supstrat CYP1A2;
English: Based on in vitro metabolism studies using recombinant human cytochrome P450, the metabolism of brexpiprazole was shown to be mainly mediated by CYP3A4 and CYP2D6 leading to formation of oxidative metabolites.
Croatian: pokazalo se da je metabolizam brekspiprazola uglavnom posredovan CYP3A4 i CYP2D6 i dovodi do stvaranja oksidacijskih metabolita.
English: QT prolongation can develop in patients treated with antipsychotics.
Croatian: U bolesnika liječenih antipsihoticima može se razviti produljenje QT-intervala.
English: CYP2D6 inhibitors
Croatian: Inhibitori CYP2D6
English: RXULTI 0.25 mg film-coated tablets Each film-coated tablet contains 0.25 mg brexpiprazole.
Croatian: RXULTI 0,25 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 0,25 mg brekspiprazola.
English: RXULTI 0.5 mg film-coated tablets Each film-coated tablet contains 0.5 mg brexpiprazole.
Croatian: RXULTI 0,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 0,5 mg brekspiprazola.
English: Known CYP2D6 poor metabolisers taking strong/moderate CYP3A4 inhibitors
Croatian: Utvrđeno spori metabolizatori CYP2D6 koji uzimaju jake/umjereno jake inhibitore CYP3A4
English: Impulse-control disorders including gambling disorder have been reported in patients treated with brexpiprazole.
Croatian: U bolesnika liječenih brekspiprazolom zabilježeni su poremećaji kontrole impulsa, uključujući kompulzivno kockanje.
English: • back pain,
Croatian: • bol u leđima
English: Based on estimations from the population pharmacokinetic analysis, CYP2D6 extensive metabolisers receiving both CYP3A4 and CYP2D6 inhibitors or CYP2D6 poor metabolisers receiving strong CYP3A4 inhibitors are expected to have approximately 4-fold to 5-fold increase in brexpiprazole concentrations and dose adjustment to a quarter of the dose is recommended for these subjects (see section 4.2).
Croatian: Na temelju procjena iz populacijske farmakokinetičke analize, u brzih metabolizatora CYP2D6 koji primaju inhibitore CYP3A4 i CYP2D6 ili sporih metabolizatora CYP2D6 koji primaju jake inhibitore
English: Each film-coated tablet contains 0.25 mg brexpiprazole.
Croatian: Jedna filmom obložena tableta sadrži 0,25 mg brekspiprazola.
English: Consider dose reduction or stopping the medication if a patient develops such urges while taking brexpiprazole (see section 4.8).
Croatian: Ako se u bolesnika tijekom uzimanja brekspiprazola jave takvi porivi, razmotrite smanjenje doze ili prekid primjene lijeka (vidjeti dio 4.8).
English: Each film-coated tablet contains 0.5 mg brexpiprazole.
Croatian: Jedna filmom obložena tableta sadrži 0,5 mg brekspiprazola.
English: Angioedema Urticaria
Croatian: • omaglica • drhtanje
English: Brexpiprazole (2 mg/day)* Brexpiprazole (4 mg/day)* Placebo Brexpiprazole (2 mg/day) Brexpiprazole (4 mg/day)* Placebo Brexpiprazole (2 mg/day)* Brexpiprazole (4 mg/day) Placebo 4 Brexpiprazole* (2 mg/day to 4 mg/day)b 150 Placebo
Croatian: (2 mg na dan)* 113 Brekspiprazol (4 mg na dan) Placebo Brekspiprazol* (2 mg na dan do 4 mg na dan)b
English: Talk to your doctor about the best way to feed your baby if you are taking RXULTI.
Croatian: Ako uzimate RXULTI, upitajte liječnika koji je najbolji način da hranite svoje dijete.
English: The incidence of blood prolactin increased was 0.9 % in 2 mg to 4 mg brexpiprazole group compared to that of 0.5 % in placebo in short-term, controlled trials.
Croatian: U kratkotrajnim kontroliranim ispitivanjima, incidencija povišenog prolaktina u krvi bila je 0,9 % u skupini liječenoj brekspiprazolom u dozi od 2 mg do 4 mg u usporedbi s onom od 0,5 % u skupini koja je primala placebo.
English: Brexpiprazole steady-state concentrations are attained within 10 days to 12 days of dosing.
Croatian: 10 dana do 12 dana doziranja.
English: Placebo Brexpiprazole (2 mg/day) Brexpiprazole (4 mg/day)* 181 94.99
Croatian: 1 Brekspiprazol (2 mg na dan)* 181 Brekspiprazol
English: les Bouillides Sophia Antipolis 06560 Valbonne France
Croatian: Elaiapharm 2881 Route des Crêtes Z.I. les Bouillides Sophia Antipolis 06560 Valbonne Francuska
English: In the brexpiprazole 12 mg/day group, the maximum placebo-adjusted mean change from baseline in the QTcl interval was 2.9 ms (90 % Cl: −1.2, 6.9) in males (n = 40) at 12 hours post-dosing and 10.4 ms (90 % Cl: 2.7, 18.2) in females (n = 13) at 24 hours post-dosing.
Croatian: CI: −1,2; 6,9) u muškaraca (n = 40) 12 sati nakon primjene doze te 10,4 ms (90 % CI: 2,7, 18,2) u žena
English: • Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include: - strong impulse to gamble excessively despite serious personal or family consequences - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive - uncontrollable excessive shopping - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.
Croatian: snažan nagon za pretjeranim kockanjem usprkos ozbiljnim posljedicama za osobu ili obitelj promijenjen ili povećan seksualni interes i ponašanje koje znatno zabrinjava Vas ili druge, na primjer, povećani seksualni poriv
English: Each film-coated tablet contains 48.2 mg lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 48,2 mg laktoze (u obliku laktoza hidrata).
English: Musculoskeletal and connective tissue disorders
Croatian: Krvožilni poremećaji venska tromboembolija
English: Strong CYP3A4 inhibitors
Croatian: Jaki inhibitori CYP3A4
English: Blood creatine phosphokinase increased
Croatian: povišena kreatin fosfokinaza u krvi povišen krvni tlak povišeni trigliceridi u krvi povišeni jetreni enzimi
English: Oesophageal dysmotility and aspiration have been associated with antipsychotic use.
Croatian: S primjenom antipsihotika povezuju se poremećaj motiliteta jednjaka i aspiracija.
English: Summary of the safety profile The most frequently observed adverse drug reactions (ADRs) were akathisia (5.6 %) and weight gain
Croatian: Najčešće opažene nuspojave bile su akatizija (5,6 %) i povećanje tjelesne težine (3,9 %).
English: Seizures
Croatian: Čimbenici
English: Mechanism of action
Croatian: Global Assessment of
English: Each film-coated tablet contains 1 mg brexpiprazole.
Croatian: Jedna filmom obložena tableta sadrži 1 mg brekspiprazola.
English: RXULTI 1 mg film-coated tablets
Croatian: RXULTI 1 mg filmom obložene tablete
English: Each film-coated tablet contains 47.9 mg lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 47,9 mg laktoze (u obliku laktoza hidrata).
English: RXULTI 0.25 mg film-coated tablets
Croatian: RXULTI 0,25 mg filmom obložene tablete
English: Each film-coated tablet contains 4 mg brexpiprazole.
Croatian: Jedna filmom obložena tableta sadrži 4 mg brekspiprazola.
English: RXULTI 2 mg film-coated tablets
Croatian: RXULTI 2 mg filmom obložene tablete
English: RXULTI 0.5 mg film-coated tablets
Croatian: RXULTI 0,5 mg filmom obložene tablete
English: Each film-coated tablet contains 2 mg brexpiprazole.
Croatian: Jedna filmom obložena tableta sadrži 2 mg brekspiprazola.
English: RXULTI 0.25 mg film-coated tablets Iron oxide E 172 (yellow, red, black)
Croatian: Željezov oksid E 172 (žuti, crveni, crni)
English: RXULTI 3 mg film-coated tablets
Croatian: RXULTI 3 mg filmom obložene tablete
English: Each film-coated tablet contains 3 mg brexpiprazole.
Croatian: Jedna filmom obložena tableta sadrži 3 mg brekspiprazola.
English: (Ki: 0.1 nM to 0.5 nM).
Croatian: (vidjeti dijelove 4.5 i 5.2).
English: RXULTI 3 mg film-coated tablets Iron oxide E 172 (red, black)
Croatian: Željezov oksid E 172 (crveni, crni)
English: Each film-coated tablet contains 46.4 mg lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 46,4 mg laktoze (u obliku laktoza hidrata).
English: Titanium dioxide
Croatian: Tardivna diskinezija
English: Light orange, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.5 on one side.
Croatian: Svjetlonarančasta, okrugla, promjera 6 mm, blago konveksna, s kosim rubovima i utisnutim BRX i 0.5 na jednoj strani.
English: Light brown, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.25 on one side.
Croatian: Svjetlosmeđa, okrugla, promjera 6 mm, blago konveksna, s kosim rubovima i utisnutim BRX i 0.25 na jednoj strani.
English: RXULTI 4 mg film-coated tablets brexpiprazole
Croatian: RXULTI 4 mg filmom obložene tablete brekspiprazol
English: Rhabdomyolysis
Croatian: • proljev
English: Difference (brexpiprazole minus placebo) in least-squares mean change from baseline, at week 6
Croatian: interval pouzdanosti liječenje statistički značajno superiorno placebu a razlika (brekspiprazol minus placebo) u srednjoj vrijednosti promjene od početne vrijednosti dobivenoj metodom najmanjih kvadrata u 6. tjednu b
English: RXULTI 3 mg film-coated tablets EU/1/18/1294/006 (28 film-coated tablets)
Croatian: RXULTI 3 mg filmom obložene tablete EU/1/18/1294/006 (28 filmom obloženih tableta)
English: CYP2D6 poor metabolisers
Croatian: Spori metabolizatori CYP2D6
English: RXULTI 1 mg film-coated tablets brexpiprazole
Croatian: RXULTI 1 mg filmom obložene tablete brekspiprazol
English: Based on the patient's clinical response and tolerability the brexpiprazole dose can be titrated to 2 mg once daily on day 5 through day 7 and then to 4 mg on day 8.
Croatian: 2 mg jedanput dnevno od 5. do 7. dana i potom na 4 mg 8. dana.
English: RXULTI 0.5 mg film-coated tablets brexpiprazole
Croatian: RXULTI 0,5 mg filmom obložene tablete brekspiprazol
English: RXULTI 4 mg film-coated tablets EU/1/18/1294/007 (28 film-coated tablets)
Croatian: RXULTI 4 mg filmom obložene tablete EU/1/18/1294/007 (28 filmom obloženih tableta)
English: Pregnancy
Croatian: • napadaji
English: Electrocardiogram QT prolonged
Croatian: Srčani poremećaji produljenje QT-intervala na elektrokardiogram u
English: RXULTI 2 mg film-coated tablets Iron oxide E 172 (yellow, black)
Croatian: Željezov oksid E 172 (žuti, crni)
English: Each film-coated tablet contains 47.4 mg lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 47,4 mg laktoze (u obliku laktoza hidrata).
English: • muscle pain,
Croatian: • bol u mišićima
English: RXULTI 2 mg film-coated tablets EU/1/18/1294/005 (28 film-coated tablets)
Croatian: RXULTI 2 mg filmom obložene tablete EU/1/18/1294/005 (28 filmom obloženih tableta)
English: Myalgia
Croatian: pvrijednost
English: RXULTI 0.25 mg film-coated tablets brexpiprazole
Croatian: RXULTI 0,25 mg filmom obložene tablete brekspiprazol
English: Each film-coated tablet contains 45.4 mg lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 45,4 mg laktoze (u obliku laktoza hidrata).
English: Dosing modifications to half the recommended doses is required for patients with known CYP2D6 poor metaboliser status.
Croatian: U bolesnika za koje je utvrđeno da su spori metabolizatori CYP2D6 potrebno je prilagoditi dozu na pola preporučene doze.
English: RXULTI 0.5 mg film-coated tablets EU/1/18/1294/002 (28 film-coated tablets)
Croatian: RXULTI 0,5 mg filmom obložene tablete EU/1/18/1294/002 (28 filmom obloženih tableta)
English: Light green, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 2 on one side.
Croatian: Svjetlozelena, okrugla, promjera 6 mm, blago konveksna, s kosim rubovima i utisnutim BRX i 2 na jednoj strani.
English: RXULTI 2 mg film-coated tablets brexpiprazole
Croatian: RXULTI 2 mg filmom obložene tablete brekspiprazol
English: RXULTI 3 mg film-coated tablets brexpiprazole
Croatian: RXULTI 3 mg filmom obložene tablete brekspiprazol
English: RXULTI 0.25 mg film-coated tablets EU/1/18/1294/001 (28 film-coated tablets)
Croatian: RXULTI 0,25 mg filmom obložene tablete EU/1/18/1294/001 (28 filmom obloženih tableta)
English: RXULTI 0.5 mg film-coated tablets Iron oxide E 172 (yellow, red)
Croatian: Željezov oksid E 172 (žuti, crveni)
English: Each film-coated tablet contains 44.4 mg lactose (as monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 44,4 mg laktoze (u obliku laktoza hidrata).
English: Known CYP2D6 poor metabolisers
Croatian: Utvrđeno spori metabolizatori CYP2D6
English: • irregular heart beat or if someone else in your family has a history of irregular heart beat (including so called QT prolongation seen with ECG monitoring).
Croatian: • nepravilne otkucaje srca ili je netko drugi u Vašoj obitelji imao nepravilne otkucaje srca
English: For nausea, the incidence in the 2 mg to 4 mg brexpiprazole group was 2.3 % overall in short-term controlled trials, compared to 2.0 % in placebo; for vomiting, these incidences were 1.0 % in the brexpiprazole-treated group compared to 1.2 % in placebo group.
Croatian: incidencija povraćanja iznosila je 1,0 % u skupini liječenoj brekspiprazolom u usporedbi s 1,2 % u skupini koja je primala placebo.
English: Light purple, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 3 on one side.
Croatian: Svjetloljubičasta, okrugla, promjera 6 mm, blago konveksna, s kosim rubovima i utisnutim BRX i 3 na jednoj strani.