natgillin/translations-raw huggingface dataset:
Twice daily divided dosing of brexpiprazole is preferable as once daily dosing results in high peak to trough fluctuation (see section 4.5).
Bolje je podijeliti dozu i primijeniti je dvaput dnevno jer doziranje jedanput dnevno rezultira velikim fluktuacijama od vršnih do najnižih vrijednosti (vidjeti dio 4.5).
Gambling disorder Impulsive behaviour Binge eating Compulsive shopping
Psihijatrijski poremećaji pokušaj samoubojstva suicidalne misli kompulzivno kockanje impulzivno ponašanje kompulzivno prejedanje kompulzivno kupovanje kompulzivno seksualno ponašanje
Film-coated tablet 10 film-coated tablets 28 film-coated tablets
Filmom obložena tableta 10 filmom obloženih tableta 28 filmom obloženih tableta
Brexpiprazole has minor to moderate influence on the ability to drive and use machines due to potential nervous system effects, such as sedation and dizziness that are common adverse drug reactions (see section 4.8).
Brekspiprazol malo ili umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima zbog mogućih učinaka na živčani sustav, kao što su sedacija i omaglica koje su česte nuspojave (vidjeti dio 4.8).
An electrocardiogram should be obtained in case of overdose and if QT interval prolongation is present, cardiac monitoring should be instituted.
U slučaju predoziranja potrebno je napraviti elektrokardiogram te ako je prisutno produljenje QT-intervala,
• increased levels of the hormone prolactin, or have a tumour in your pituitary gland.
• povišene razine hormona prolaktina ili tumor hipofize.
Following oral administration in pregnant rats, foetus and milk transfer of brexpiprazole was demonstrated at concentrations that were generally comparable to levels seen in maternal blood.
Dokazan je prijenos brekspiprazola na fetuse nakon peroralne primjene u skotnih ženki štakora te u mlijeko pri koncentracijama koje su uglavnom bile usporedive s razinama opaženima u majčinoj krvi.
Film-coated tablet 28 film-coated tablets
Filmom obložena tableta 28 filmom obloženih tableta
Efficacy was demonstrated in trial 1 for both brexpiprazole 2 mg/day and 4 mg/day and replicated in trial 2 only for brexpiprazole 4 mg/day and in trial 3 only for brexpiprazole 2 mg/day.
Djelotvornost brekspiprazola dokazana je u ispitivanju 1 i za dozu od 2 mg na dan i za dozu od 4 mg na dan, što je u ispitivanju 2 ponovljeno samo za brekspiprazol u dozi od 4 mg na dan te u ispitivanju 3 samo za brekspiprazol u dozi od 2 mg na dan.
Very common Common Uncommon
Manje često Nepoznato
Based on in vitro data brexpiprazole showed little to no inhibition of other CYP450 isozymes.
Na temelju podataka in vitro pokazalo se da brekspiprazol gotovo uopće ili nimalo ne inhibira druge izoenzime CYP450.
In addition, the frequencies of prolactin elevations > 1 × ULN in the 2 mg to 4 mg brexpiprazole group was 13.7 % in females versus 6.4 % in placebo and 11.1 % in males versus 10.3 % in placebo group.
Nadalje, učestalost povišenja prolaktina > 1 × GGN u skupini liječenoj brekspiprazolom u dozi od 2 mg do 4 mg bila je 13,7 % u žena naspram 6,4 % u skupini koja je primala placebo te 11,1 % u muškaraca naspram 10,3 % u skupini koja je primala placebo.
Patients taking CYP2D6 inhibitors and/or CYP3A4 inhibitors
Bolesnici koji uzimaju inhibitore CYP2D6 i/ili inhibitore CYP3A4
Akathisia was the most frequently reported EPS related ADR in the brexpiprazole 2 mg/day to 4 mg/day group (5.6 %) compared to 4.5 % in placebo, followed by tremor (2.7 %) compared to 1.2 % in placebo.
Ekstrapiramidni simptomi (EPS) Akatizija je bila najčešće prijavljena nuspojava povezana s EPS-om u skupini koja je primala brekspiprazol u dozi od 2 mg na dan do 4 mg na dan (5,6 %) u usporedbi s 4,5 % u skupini koja je primala placebo, a zatim tremor (2,7 %) u usporedbi s 1,2 % u skupini koja je primala placebo.
In the three fixed-dose, short-term trials (trials 1, 2 and 3), subjects were randomised to brexpiprazole 2 mg once daily, 4 mg once daily or placebo.
U tri kratkotrajna ispitivanja fiksne doze (ispitivanja 1, 2 i 3), ispitanici su bili randomizirani u skupinu koja je primala brekspiprazol u dozi od 2 mg jedanput dnevno, skupinu koja je primala brekspiprazol u dozi od 4 mg jedanput dnevno ili skupinu koja je primala placebo.
The key secondary endpoint in trials 1, 2 and 4 was the Clinical Global Impression of Severity (CGI-S) of schizophrenia, a 7-point clinician's assessment of the severity of disease.
Ključna sekundarna mjera ishoda u ispitivanjima 1, 2 i 4 bila je opći klinički dojam o težini (engl.
• medicines changing the salt concentrations in your body (causing a so-called electrolyte imbalance),
• lijekove koji mijenjaju koncentracije soli u tijelu (uzrokujući takozvanu neravnotežu elektrolita), • lijekove koji povisuju razinu enzima pod nazivom kreatin fosfokinaza (CPK),
The incidence of akathisia in the brexpiprazole 1 mg/day, 2 mg/day, and 4 mg/day groups was 3.0 %, 4.6 %, and 6.5 %, respectively, compared with 5.2 % of subjects in the placebo group.
Incidencija akatizije u skupinama koje su primale brekspiprazol u dozi od 1 mg na dan, 2 mg na dan i 4 mg na dan iznosila je 3,0 %, 4,6 % odnosno 6,5 % u usporedbi s 5,2 % u skupini ispitanika koji su primali placebo.
• from day 5 to day 7 take two 1 mg film-coated tablet per day,
• tijekom prva 4 dana uzmite jednu filmom obloženu tabletu od 1 mg na dan • od 5. dana do 7. dana uzmite dvije filmom obložene tablete od 1 mg na dan
Cases of venous thromboembolism (VTE) have been reported with antipsychotics.
Kod primjene antipsihotika prijavljeni su slučajevi venske tromboembolije (VTE).
The effects of brexpiprazole at therapeutic (4 mg) and supra-therapeutic (12 mg) doses on QT interval were evaluated in subjects with schizophrenia or schizoaffective disorder in a randomised, double-blind, placebo- and positive-controlled (moxifloxacin), parallel-arm trial.
Učinci brekspiprazola u terapijskim (4 mg) i supraterapijskim (12 mg) dozama na QT-interval procijenjeni su u ispitanika sa shizofrenijom ili shizoafektivnim poremećajem u randomiziranom,
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Može biti potrebno nekoliko dana do nekoliko tjedana terapije antipsihoticima prije nego što nastupi poboljšanje kliničkog stanja bolesnika.
If the CYP3A4 inhibitor/inducers or CYP2D6 inhibitor is withdrawn, the dose may need to be returned to the original dose (see section 4.5).
CYP2D6, dozu će možda trebati vratiti na prvobitnu dozu (vidjeti dio 4.5).
Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking brexpiprazole.
Dok uzimaju brekspiprazol, bolesnici mogu osjećati pojačane porive, osobito za kockanjem, te nemogućnost kontroliranja tih poriva.
If you forget to take RXULTI
Ako ste zaboravili uzeti lijek RXULTI
Spontaneous cases reporting completed suicide and suicide attempt have been reported in the post-marketing setting.
Nakon stavljanja lijeka u promet zabilježene su spontane prijave slučajeva izvršenog samoubojstva i pokušaja samoubojstva.
Key secondary efficacy measure: CGI-S Mean baseline score (SD)
Ključna sekundarna mjera djelotvornosti: CGI-S
• a history of seizures (fits) or epilepsy.
• napadaje ili epilepsiju u povijesti bolesti.
In the short-term trials, the primary efficacy endpoint was defined as the mean change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total scores, a multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganised thoughts, uncontrolled hostility/excitement, and anxiety/depression.
Positive and Negative Syndrome Scale, PANSS), upitniku s više dijelova koji se sastoji od pet faktora za procjenu pozitivnih simptoma, negativnih simptoma, neorganiziranih misli, nekontroliranog neprijateljskog ponašanja/uzbuđenosti i tjeskobe/depresije.
• thoughts or feelings about hurting yourself or to commit suicide or a suicide attempt (uncommon side effect - may affect up to 1 in 100 people).
Odmah obavijestite liječnika ako imate: • misli o samoozljeđivanju ili osjećate da biste si mogli nauditi ili počiniti samoubojstvo ili pokušaj samoubojstva (manje česta nuspojava - može se javiti u do 1 na 100 osoba).
If you stop taking RXULTI
Ako prestanete uzimati lijek RXULTI
Co-administration of rifampicin (600 mg twice daily for 12 days), a potent CYP3A4 inducer, with a single 4 mg oral dose of brexpiprazole resulted in an approximate 31 % and 73 % decrease in brexpiprazole Cmax and AUC, respectively.
Istodobna primjena rifampicina (600 mg dvaput dnevno tijekom 12 dana), jakog induktora CYP3A4, s jednom peroralnom dozom brekspiprazola od 4 mg rezultirala je sniženjem Cmax brekspiprazola za 31 % i AUC-a za 73 %.
Co-administration of ketoconazole (200 mg twice daily for 7 days), a potent inhibitor of CYP3A4, with a 2 mg single oral dose of brexpiprazole increased the AUC of brexpiprazole by 97 % and no change in Cmax.
Istodobna primjena ketokonazola (200 mg dvaput dnevno tijekom 7 dana), jakog inhibitora CYP3A4, s jednom peroralnom dozom brekspiprazola od 2 mg povećala je AUC brekspiprazola za 97 %, bez promjene u Cmax.
• pain in the upper abdomen,
• bol u gornjem dijelu trbuha
Diarrhoea Nausea Abdominal pain upper
Poremećaji probavnog sustava proljev mučnina bol u gornjem dijelu abdomena zubni karijes vjetrovi
In subjects (n = 10) with severe renal impairment (CLcr < 30 mL/min), AUC of oral brexpiprazole (3 mg single dose) compared to matched healthy subjects was increased by 68 % while its Cmax was not changed.
AUC peroralnog brekspiprazola (jedne doze od 3 mg) u ispitanika (n = 10) s teškim oštećenjem funkcije bubrega (CLcr < 30 ml/min) u usporedbi s odgovarajućim zdravim ispitanicima bio je povećan za 68 %, dok mu se Cmax nije promijenio.
For patients with moderate to severe renal impairment (creatinine clearance CLcr < 60 mL/minute), the maximum recommended dose is reduced to 3 mg once daily (see section 4.2).
U bolesnika s umjerenim do teškim oštećenjem funkcije bubrega (klirens kreatnina CLcr < 60 ml/min), maksimalna preporučena doza snižena je na 3 mg jedanput dnevno (vidjeti dio 4.2).
EU/1/18/1294/003 (10 film-coated tablets) EU/1/18/1294/004 (28 film-coated tablets)
EU/1/18/1294/003 (10 filmom obloženih tableta) EU/1/18/1294/004 (28 filmom obloženih tableta)
• parkinsonism - medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity),
• parkinsonizam - zdravstveno stanje s mnoštvom različitih simptoma koji uključuju smanjene ili usporene pokrete, usporene misli, iznenadno trzanje prilikom savijanja udova (ukočenost kao kod zupčastog kotača), sitne korake uz povlačenje nogu pri hodu, drhtanje, neznatnu izražajnost lica ili bezizražajno lice, ukočenost mišića, slinjenje
In the short-term controlled trials with brexpiprazole, 3 TEAEs related to QT prolongation were reported in the 2 mg to 4 mg group (0.3 %), compared with 3 TEAEs (0.5 %) reported for subjects on placebo.
U kratkotrajnim kontroliranim ispitivanjima brekspiprazola zabilježena su 3 štetna događaja nastala tijekom liječenja povezana s produljenjem QT-intervala u skupini koja je primala 2 mg do 4 mg brekspiprazola (0,3 %) u usporedbi s 3 štetna događaja nastala tijekom liječenja (0,5 %) zabilježena u ispitanika koji su primali placebo.
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).
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).
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.
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.
Close supervision of high-risk patients should accompany antipsychotic treatment.
Visokorizične bolesnike koji se liječe antipsihoticima potrebno je strogo nadzirati.
Once daily dosing while CYP3A4 inducers are administered results in high peak to trough fluctuation, hence twice daily divided dosing is preferable.
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.
RXULTI contains lactose
RXULTI sadrži laktozu
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]).
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]).
Patients taking strong CYP3A4 inducers
Bolesnici koji uzimaju jake induktore CYP3A4
Otsuka Pharmaceutical Italy S.r.l.
Otsuka Pharmaceuticals (UK) Ltd.
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.
Peroralno primijenjen brekspiprazol nije povećao incidenciju tumora u dvogodišnjem ispitivanju kancerogenosti u mužjaka i ženki štakora i mužjaka miša pri izloženosti do
A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotics.
U bolesnika liječenih antipsihoticima može se razviti sindrom potencijalno ireverzibilnih, nevoljnih diskinetičkih pokreta.
If brexpiprazole is administered concomitantly with medicinal products known to cause QT prolongation or electrolyte imbalance, caution should be used.
Potreban je oprez ako se brekspiprazol primjenjuje istodobno s lijekovima za koje je utvrđeno da uzrokuju produljenje QT-intervala ili neravnotežu elektrolita.
Leukopenia, neutropenia and agranulocytosis (including fatal cases) have been reported during treatment with antipsychotics.
Tijekom liječenja antipsihoticima zabilježene su leukopenija, neutropenija i agranulocitoza (uključujući smrtne slučajeve).
Dose adjustments should be made in patients taking concomitant strong CYP3A4 inhibitors/inducers or strong CYP2D6 inhibitors.
Dozu je potrebno prilagoditi u bolesnika koji istodobno uzimaju jake inhibitore/induktore CYP3A4 ili jake inhibitore CYP2D6.
In clinical trials, only a few, nonserious, QT prolongations have been reported with brexpiprazole.
U kliničkim je ispitivanjima zabilježeno svega nekoliko slučajeva produljenja QT-intervala uz brekspiprazol, koji nisu bili ozbiljni.
Tell your doctor if this happens.
Ako se to dogodi, obratite se liječniku.
Patients with kidney problems
Bolesnici koji imaju probleme s bubrezima
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
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
The maximum recommended dose in patients with moderate to severe impaired renal function is reduced to 3 mg once daily (see section 5.2).
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).
A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic treatment.
Povezano s antipsihotičkim liječenjem zabilježen je potencijalno smrtonosan kompleks simptoma koji se naziva maligni neuroleptični sindrom (MNS).
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.
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.
• during blood tests your doctor may find increases in liver enzymes.
• na krvnim pretragama, liječnik Vam može pronaći veće količine triglicerida u krvi • na krvnim pretragama, liječnik Vam može pronaći povećane razine jetrenih enzima.
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.
Na temelju ispitivanja in vivo, brekspiprazol nije ni supstrat niti inhibitor efluksnih prijenosnika poput prijenosnika za rezistenciju na više lijekova (engl.
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.
(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.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE
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.
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.
Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja kašalj
QT prolongation
Produljenje QT-intervala
• 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.
nepravilan nalaz na pregledu srca (EKG), produljenje QT-intervala - nije poznato u koliko ljudi se pojavljuje.
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane povećanje tjelesne težine
Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics.
U bolesnika liječenih atipičnim antipsihoticima zabilježena je hiperglikemija, u nekim slučajevima krajnje visoka i povezana s ketoacidozom ili hiperosmolarnom komom ili smrću.
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.
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
Strong/moderate CYP2D6 inhibitors with strong/moderate CYP3A4 inhibitors
Jaki/umjereno jaki inhibitori CYP2D6 s jakim/umjereno jakim inhibitorima CYP3A4
Parkinsonism Seizures Neuroleptic malignant syndrome (NMS)
Poremećaji živčanog sustava akatizija omaglica tremor sedacija parkinsonizam napadaji maligni neuroleptički sindrom (MNS)
• The active substance is brexpiprazole.
• Djelatna tvar je brekspiprazol.
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).
Daljnje prilagodbe doze na četvrtinu preporučene doze potrebne su kod utvrđeno sporih metabolizatora CYP2D6 dok uzimaju jake ili umjereno jake inhibitore CYP3A4
• antidepressants or herbal remedies used to treat depression and anxiety (such as fluoxetine,
• 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),
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.
Na temelju ispitivanja pomoću enzima ljudske jetre in vitro, brekspiprazol nije supstrat CYP1A2;
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.
pokazalo se da je metabolizam brekspiprazola uglavnom posredovan CYP3A4 i CYP2D6 i dovodi do stvaranja oksidacijskih metabolita.
QT prolongation can develop in patients treated with antipsychotics.
U bolesnika liječenih antipsihoticima može se razviti produljenje QT-intervala.
CYP2D6 inhibitors
Inhibitori CYP2D6
RXULTI 0.25 mg film-coated tablets Each film-coated tablet contains 0.25 mg brexpiprazole.
RXULTI 0,25 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 0,25 mg brekspiprazola.
RXULTI 0.5 mg film-coated tablets Each film-coated tablet contains 0.5 mg brexpiprazole.
RXULTI 0,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 0,5 mg brekspiprazola.
Known CYP2D6 poor metabolisers taking strong/moderate CYP3A4 inhibitors
Utvrđeno spori metabolizatori CYP2D6 koji uzimaju jake/umjereno jake inhibitore CYP3A4
Impulse-control disorders including gambling disorder have been reported in patients treated with brexpiprazole.
U bolesnika liječenih brekspiprazolom zabilježeni su poremećaji kontrole impulsa, uključujući kompulzivno kockanje.
• back pain,
• bol u leđima
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).
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
Each film-coated tablet contains 0.25 mg brexpiprazole.
Jedna filmom obložena tableta sadrži 0,25 mg brekspiprazola.
Consider dose reduction or stopping the medication if a patient develops such urges while taking brexpiprazole (see section 4.8).
Ako se u bolesnika tijekom uzimanja brekspiprazola jave takvi porivi, razmotrite smanjenje doze ili prekid primjene lijeka (vidjeti dio 4.8).
Each film-coated tablet contains 0.5 mg brexpiprazole.
Jedna filmom obložena tableta sadrži 0,5 mg brekspiprazola.
Angioedema Urticaria
• omaglica • drhtanje
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
(2 mg na dan)* 113 Brekspiprazol (4 mg na dan) Placebo Brekspiprazol* (2 mg na dan do 4 mg na dan)b