FrancophonIA/ELRC3.0 huggingface dataset:
English: Parkinsonism Seizures Neuroleptic malignant syndrome (NMS)
Maltese: Sindrome Malinn Newrolettiku (NMS - Neuroleptic Malignant Syndrome)
English: Placebo Brexpiprazole (2 mg/day) Brexpiprazole (4 mg/day)* 181 94.99
Maltese: Brexpiprazole (4 mg/jum)* 181
English: EU/1/18/1294/003 (10 film-coated tablets) EU/1/18/1294/004 (28 film-coated tablets)
Maltese: EU/1/18/1294/003 (10 pilloli miksija b'rita) EU/1/18/1294/004 (28 pilloli miksija b'rita)
English: • anticonvulsants used to treat epilepsy,
Maltese: • antikonvulsanti użati biex jittrattaw l epilessija,
English: Seizures have been reported during use of brexpiprazole (see section 4.8).
Maltese: Aċċessjonijiet ġew rapportati waqt l-użu ta' brexpiprazole (ara sezzjoni 4.8).
English: The pharmacokinetic of brexpiprazole is dose proportional and time-invariant after single-dose (0.2 mg to 8 mg) and multiple-dose (0.5 mg to 4 mg) using once-daily administration.
Maltese: Il-farmakokinetiċi ta' brexpiprazole huma proporzjonali mad-doża u huma invarjanti mal-ħin wara doża unika (0.2 mg sa 8 mg) u doża multipla (0.5 mg sa 4 mg) b'doża li tittieħed darba kuljum.
English: Neuroleptic Malignant Syndrome (NMS)
Maltese: Sindrome Malinn Newrolettiku (NMS)
English: 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.
Maltese: Fil-provi b'kontroll fuq terminu ta' żmien qasir bi brexpiprazole, 3 TEAEs relatati mat-titwil tal-QT ġew rapportati fil-grupp ta' 2 mg sa 4 mg (0.3 %), meta mqabbla ma' 3 TEAEs (0.5 %) għal individwi fuq plaċebo.
English: Brexpiprazole is highly protein bound in plasma (greater than 99 %) to serum albumin and α1-acid glycoprotein, and its protein binding is not affected by renal or hepatic impairment.
Maltese: Brexpiprazole jintrabat b'mod qawwi mal-proteini fil-plażma (aktar minn 99 %) ma' albumina fis-serum u ma' glikoproteina aċida -α1, u lirbit mal-proteini mhux affettwat b'indeboliment tal-kliewi jew tal-fwied.
English: • shaking,
Maltese: • sturdament,
English: 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.
Maltese: Barra minn hekk, il-frekwenzi ta' livelli ogħla ta' prolaktin > 1 × LON filgrupp ta' brexpiprazole ta' 2 mg sa 4 mg kienu 13.7 % fin-nisa versus 6.4 % fil-plaċebo u 11.1 % fl irġiel versus 10.
English: • medicines to correct heart rhythm (such as quinidine),
Maltese: • mediċini li jikkoreġu r-ritmu tal qalb (bħal quinidine),
English: RXULTI contains lactose
Maltese: RXULTI fih lactose
English: Patients treated with any antipsychotics, including brexpiprazole, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness).
Maltese: Pazjenti trattati bi kwalunkwe antipsikotiku, li jinkludi brexpiprazole, għandhom jiġu osservati għal sinjali u sintomi ta' ipergliċemija (bħal polidipsija, poliurja, polifaġja u dgħufija)
English: Based on results of in vitro studies brexpiprazole protein binding is not affected by warfarin, diazepam, and digitoxin.
Maltese: Abbażi ta' riżultati minn studji in vitro l-irbit ta' brexpiprazole ma' proteini mhux affettwat b'warfarina, diazepam u digitoxin.
English: Table 3: Key secondary efficacy results for 6-week trials in schizophrenia Trial
Maltese: Tabella 3: Riżultati ta' effikaċja sekondarja għal provi ta' 6 ġimgħat fi skiżofrenija
English: Spontaneous cases reporting completed suicide and suicide attempt have been reported in the post-marketing setting.
Maltese: Każijiet spontanji li rraportaw suwiċidju komplut u attentat ta' suwiċidju ġew rapportati fl-ambjent ta' wara t-tqegħid fissuq.
English: Les Bouillides-Sophia Antipolis, 06560 Valbonne
Maltese: Elaiapharm2881 Route des Crêtes, Z.I. Les Bouillides-Sophia Antipolis, 06560 Valbonne
English: Available pharmacodynamic/toxicological data in animals have shown excretion of brexpiprazole/ metabolites in milk of rats (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika mill-annimali wriet li kien hemm eliminazzjoni tal-metaboliti ta' brexpiprazole fil-ħalib tas-sider ta' firien (ara sezzjoni 5.3).
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotics.
Maltese: Każijiet ta' tromboemboliżmu venuż (VTE, venous thromboembolism) kienu rrappurtati bi prodotti mediċinali antipsikotiċi.
English: In terms of gender differences, there were higher observed frequencies of nausea (4.8 % versus 2.8 %) and vomiting (4.6 % versus 1.4 %) in females compared to males among brexpiprazole-treated subjects in short-term trials, in subjects receiving placebo: the frequency for nausea was 2.8 % for males versus 3.2 % for females and for vomiting the frequency was 3.0 % for males versus 2.6 % for females (see section 5.2).
Maltese: F'termini ta' differenza bejn is-sessi, ġiet osservata frekwenzi ogħla ta' dardir (4.8 % versus 2.8 %) u remettar (4.6 % versus 1.4 %) f'nisa meta mqabbla ma' rġiel fost individwi trattati bi brexpiprazole fi provi fuq terminu ta' żmien qasir, f'individwi li rċevew plaċebo: il-frekwenza għad-dardir kienet ta' 2.8 % għall-irġiel versus 3.2 % għan-nisa u għar-rimettar il-frekwenza kienet ta' 3.0 % għall-irġiel versus 2.6 % għan-nisa (ara sezzjoni 5.2)
English: 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.
Maltese: L-għoti fl-istess waqt ta' rifampicin (600 mg darbtejn kuljum għal 12-il jum), induttur qawwi ta' CYP3A4, b'doża orali waħda ta' 4 mg brexpiprazole rriżulta fi tnaqqis ta' madwar 31 % u 73 % f'brexpiprazole Cmax u AUC, rispettivament.
English: RXULTI 1 mg film-coated tablets 10 or 28 film-coated tablets in Aluminium/PVC blisters.
Maltese: RXULTI 1 mg pilloli miksija b'rita 10 jew 28 pilloli miksija b'rita f'folji tal-Aluminju/PVC.
English: In female mice, an increased incidence of mammary gland adenocarcinoma and adeno-squamous carcinoma, and pars distalis adenoma of the pituitary gland, was observed at similar or even lower clinically relevant exposures: these prolactin-mediated endocrine tumours were also observed in rodents with other antipsychotics and their clinical relevance is unknown.
Maltese: Fi ġrieden nisa, inċidenza ogħla ta' adenokarċinoma fil-glandola mammarja u karċinoma adeno-skwamuża, u adenoma pars distalis tal-glandola pitwitarja kienet osservata f'esponimenti klinikament rilevanti simili jew anke aktar baxxi: dawn it-tumuri endokrinali medjati bi prolaktin kienu osservati f'annimali gerriema ma' antipsikotiċi oħra u r-rilevanza klinika tagħhom mhix magħrufa.
English: This medicinal product may pose a risk to the environment (see section 5.3).
Maltese: Dan il-prodott mediċinali jista' jkun ta' riskju għall-ambjent (ara sezzjoni 5.3).
English: In long-term, open-label trials, TEAEs related to suicidality were reported for 23 subjects (1.6 %).
Maltese: Fi provi fuq terminu ta' żmien twil, bit-tikketta tidher, TEAEs marbuta ma' suwiċidalità ġew rapportati għal 23 individwu (1.6 %).
English: CYP2D6 genotype
Maltese: Ġenotip CYP2D6
English: An increased frequency of weight gain has been observed with increased duration of brexpiprazole treatment (see section 4.8).
Maltese: Frekwenza ogħla ta' żieda fil-piż ġiet osservata b'żieda fil-perijodu ta' trattament bi brexpiprazole (ara sezzjoni 4.8).
English: These improvements were maintained during the 52-week double-blind maintenance phase in patients on brexpiprazole whereas patients randomised to placebo showed deterioration in PANSS, CGI-S and CGI-I, and GAF scores [ANCOVA LOCF]).
Maltese: Dan it-titjib kien mantenut waqt ilfażi ta' manteniment double-blind ta' 52 ġimgħa f'pazjenti fuq brexpiprazole waqt li pazjenti magħżula b'mod każwali biex jirċievu plaċebo wrew deterjorament fil-punteġġi PANSS, CGI-S u CGI-I, u GAF (ANCOVA LOCF).
English: Potential for brexpiprazole to affect other medicinal products
Maltese: Potenzjal ta' brexpiprazole li jaffettwa prodotti mediċinali oħra
English: • certain antibiotics used to treat tuberculosis (such as rifampicin),
Maltese: • ċerti antibijotiċi użati biex jittrattaw it-tuberkolosi (bħal rifampicin),
English: LS Mean Least-squares mean CI
Maltese: Standard error (Errur standard) LS Mean Least-squares mean (Medja tal-inqas kubi) CI
English: The incidences of other EPS-related ADRs reported in short-term, controlled trials are dyskinesia (0.4 %), extrapyramidal disorder (1.8 %) and Parkinsonism (0.4 %).
Maltese: L-inċidenzi ta' ADRs oħrajn relatati ma' EPS rapportati waqt provi fuq terminu ta' żmien qasir, b'kontroll kienu diskinesja (0.4 %), disturb estrapiramidali (1.8 %) u
English: Extrapyramidal symptoms (including acute dystonia) are known class effects for antipsychotics.
Maltese: Sintomi ekstrapiramidali (li jinkludu distonja) huma effetti magħrufa tal-klassi għal antipsikotiċi.
English: Cardiac disorders
Maltese: Diskineżja tardiva
English: 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.
Maltese: Akatisja kienet l-aktar ADR relatata ma' EPS rapportata b'mod frekwenti fil-grupp ta' brexpiprazole 2 mg/jum sa 4 mg/jum (5.6 %) meta mqabbel ma' 4.5 % fil-plaċebo, segwit mir-rogħda (2.7 %) meta mqabbel ma' 1.2 % fil-plaċebo.
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.
Maltese: Faħam attivat u sorbitol (50 g/240 mL), mogħtijin mill-ħalq siegħa wara li tibla' 2 mg doża orali ta' brexpiprazole, naqqas is-Cmax u l-AUC ta' brexpiprazole b'madwar 5 % sa 23 % u 31 % sa 39 % rispettivament; madanakollu, mhemmx biżżejjed informazzjoni disponibbli fuq il-potenzjal terapewtiku ta' faħam attivat fit-trattament ta' doża eċċessiva bi brexpiprazole.
English: Subgroup analyses from this trial suggested that the QTc prolongation was larger in female subjects than in males (see section 5.1).
Maltese: Analiżi tas-sottogrupp minn din ilprova ssuġġeriet li t-titwil QTc kien akbar fin-nisa milli fl-irġiel (ara sezzjoni 5.1)
English: Standard deviation
Maltese: Standard deviation (Devjazzjoni standard)
English: Tél/Tel: +32 2 535 79 79 Tél/Tel: +32 2 340 2828
Maltese: +32 2 535 79 79 Tél/Tel:
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.
Maltese: F'individwi (n = 22) bi gradi varji ta' indeboliment tal-fwied (Child-Pugh Klassijiet A, B, u Ċ), l-AUC ta' brexpiprazole orali (doża waħda ta' 2 mg), mqabbla ma' individwi b'saħħithom paragunabbli, żdiedet b'24 % f'indeboliment tal-fwied ħafif, żdiedet b'60 % f'indeboliment tal-fwied moderat, u ma nbidletx f'indeboliment tal-fwied sever.
English: Cardiovascular toxicity
Maltese: Tossiċità kardjovaskulari
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.
Maltese: Fil-grupp ta' brexpiprazole 12 mg/jum, il-bidla massima medja aġġustata għall-plaċebo mil-linja bażi fl-intervall ta' QTcl kienet ta' 2.9 ms (90 % Cl: −1.2, 6.9) f'irġiel (n = 40) fi 12-il siegħa wara d-dożaġġ u 10.4 ms (90 % Cl:
English: Genotoxicity, carcinogenicity
Maltese: Ġenotossiċità, karċinoġeniċità
English: • medicines known to prolong your QT interval (an important measurement of your heart function in an electrocardiogram [ECG]),
Maltese: • mediċini magħrufa li jtawwlu l-intervall QT tiegħek (kejl importanti tal-funzjoni ta' qalbek f'elettrokardjogramma [ECG]),
English: Neuroleptic malignant syndrome
Maltese: Sindrome malinn newrolettiku
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).
Maltese: Id-doża massima rakkomandata f'pazjenti b'funzjoni tal-kliewi indebolita b'mod moderat sa sever hi mnaqqsa għal 3 mg darba kuljum (ara sezzjoni 5.2).
English: Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP2D6 inhibitors (quinidine, paroxetine, and fluoxetine).
Maltese: Abbażi ta' studji ta' interazzjoni, l-aġġustament fid-doża ta' brexpiprazole għal nofs id-doża hu rakkomandat meta jingħata flimkien ma' impedituri qawwija ta' CYP2D6 (quinidine, paroxetine, u fluoxetine).
English: 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.
Maltese: Fil-provi fuq terminu ta' żmien qasir, il-punt aħħari ta' effikaċja primarju kien definit bħala l-bidla medja mil-linja bażi għal ġimgħa 6 fil-punteġġi totali tal-Iskala tas-Sindrome Pożittiv u Negattiv (PANSS - Positive and Negative Syndrome Scale), inventarju ta' oġġetti multipli magħmul minn ħames fatturi biex jevalwa sintomi pożittivi, sintomi negattivi, ħsibijiet diżorganizzati, ostilità inkontrollata/eċċitament, u ansjetà/depressjoni.
English: CYP3A4 inhibitors
Maltese: CYP3A4
English: It is not possible to advise on a minimum effective/safe dose in this population.
Maltese: Mhux possibbli li jingħata parir fuq doża minima effettiva/sikura f'din il-popolazzjoni.
English: RXULTI with food and alcohol
Maltese: RXULTI ma' ikel u alkoħol
English: Brexpiprazole is very persistent and very bioaccumulative but not toxic, to the environment: possible enrichment of brexpiprazole in terrestrial food chains might pose a concern (see section 6.6).
Maltese: Brexpiprazole huwa persistenti ħafna u bijoakkumulattiv ħafna imma mhux tossiku għall-ambjent: hemm possibilita ta' arrikament ta' brexpiprazole f'katini tal-ikel terrestri li jista' jkun ta' tħassib (ara sezzjoni 6.6).
English: In short-term, controlled trials, the percentage of subjects with clinically significant weight gain (increase of ≥ 7 % from baseline in body weight) was 9.1 % in the brexpiprazole 2 mg/day to 4 mg/day group, compared with 3.8 % in the placebo group.
Maltese: Fi provi kkontrollati fuq terminu ta' żmien qasir, il-perċentwali ta' individwi b'żieda fil-piż klinikament sinjifikanti (żieda ta' ≥ 7 % mil-linja bażi fil-piż tal-ġisem) kien ta' 9.1 % fil-grupp ta' 2 mg/jum sa 4 mg/jum ta' brexpiprazole, paragunat ma' 3.8 % fil-grupp tal-plaċebo.
English: Table 2: Primary efficacy results for 6-week trials in schizophrenia Trial
Maltese: Tabella 2: Riżultati ta' effikaċja primarja għal provi ta' 6 ġimgħat fi skiżofrenija
English: • diarrhoea,
Maltese: • attakk epilettiku,
English: In vivo, the metabolism of brexpiprazole is mainly mediated by CYP3A4 and CYP2D6 leading to formation of oxidative metabolites with only one metabolite, DM-3411, present in plasma with more than 10 % of plasma exposure.
Maltese: In vivo, il-metaboliżmu ta' brexpiprazole huwa prinċipalment medjat permezz ta' CYP3A4 u CYP2D6 li jwassal għal formazzjoni ta' metaboliti ossidattivi b'metabolit wieħed biss, DM-3411, preżenti fil-plażma b'aktar minn esponiment ta' 10 % fil-plażma.
English: • cough,
Maltese: • gass,
English: Brexpiprazole can elevate prolactin levels.
Maltese: Żieda fil-livelli ta' enzimi talfwied.
English: In short-term, controlled trials, Treatment Emergent Adverse Events (TEAEs) related to suicidality were reported for 8 subjects (0.5 %, 2 serious events, 1 leading to discontinuation) in the all brexpiprazole treatment group and 3 subjects (0.4 %, none serious) in the placebo group.
Maltese: Fi provi fuq terminu ta' żmien qasir, b'kontroll, Każijiet Avversi Emerġenti bi Trattament (TEAEsTreatment Emergent Adverse Events) marbuta ma' suwiċidalità ġew rapportati għal 8 individwi (0.5 %, 2 każijiet serji, 1 wassal għal waqfien) fil-grupp ta' trattament kollu ta' brexpiprazole u 3 individwi (0.4 %, xejn serji) fil-grupp tal-plaċebo.
English: Brexpiprazole (2 mg/day)* 180 95.85 Brexpiprazole (4 mg/day)* 178 94.70
Maltese: Brexpiprazole (4 mg/jum)* 178
English: Dental caries Flatulence
Maltese: Karje tas-snien Gass
English: Leukopenia, neutropenia and agranulocytosis (including fatal cases) have been reported during treatment with antipsychotics.
Maltese: Lewkopenija, newtropenija u agranuloċitosi (li jinkludu każijiet fatali) ġew rappurtati waqt trattament b'antipsikotiċi.
English: RXULTI is indicated for the treatment of schizophrenia in adult patients.
Maltese: RXULTI hu indikat għat-trattament ta' skiżofrenija f'pazjenti adulti.
English: Light brown, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.25 on one side.
Maltese: Kannella ċara, tonda, b'dijametru ta' 6 mm, konvessa baxxa u bit-tarf imċanfar, b'BRX u 0.25
English: Effects observed in repeated-dose toxicity studies in rats and monkeys were mainly related to the exaggerated pharmacological activity of brexpiprazole.
Maltese: Effetti osservati fi studji ta' tossiċità ta' doża ripetuta fil-firien u x-xadini kienu prinċipalment relatati għall-attività farmakoloġika eżagerata ta' brexpiprazole.
English: • or had problems with your movements called extrapyramidal symptoms (EPS) in the past.
Maltese: • jew kellek problemi bil-movimenti tiegħek li jissejħu sintomi estrapiramidali (EPSextrapyramidal symptoms) fil-passat.
English: Co-administration of a 2 mg single oral dose of brexpiprazole with quinidine (324 mg/day for 7 days), a potent inhibitor of CYP2D6, increased the AUC of brexpiprazole by 94 % and no change in Cmax.
Maltese: L-għoti fl-istess waqt ta' 2 mg doża orali waħda ta' brexpiprazole ma' quinidine (324 mg/jum għal 7 ijiem), impeditur qawwi ta' CYP2D6, żied l-AUC ta' brexpiprazole b'94 % u l-ebda bidla f'Cmax.
English: Patients at increased risk of these adverse reactions (e.g. elderly) or at increased risk of developing complications from hypotension include those with dehydration, hypovolemia, treatment with antihypertensive medicinal products, history of cardiovascular disease (e.g., heart failure, myocardial infarction, ischemia, or conduction abnormalities), history of cerebrovascular disease, as well as patients who are antipsychotic-naive.
Maltese: Pazjenti b'riskju akbar ta' dawn ir-reazzjonijiet avversi (eż. l-anzjani) jew b'riskju ogħla li jiżviluppaw kumplikazzjonijiet minn pressjoni baxxa jinkludu dawk b'deidrazzjoni, ipovolemja, trattament bi prodotti mediċinali ta' kontra l-pressjoni għolja, storja ta' mard kardjovaskulari (eż. insuffiċjenza tal-qalb, infart mijokardjali, iskemija jew abnormalitajiet fit-trasmissjoni), storja ta' mard ċerebrovaskulari, kif ukoll pazjenti li m'għandhomx esperjenza ta' mediċini antipsikotiċi.
English: A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic treatment.
Maltese: Kumpless sintomatiku potenzjalment fatali riferut bħala Sindrome Malinn Newrolettiku (NMS) ġie rapportat flimkien ma' trattament antipsikotiku.
English: At steady-state, DM-3411 represents 23.1 % to 47.7 % of brexpiprazole exposure (AUC) in plasma.
Maltese: Fl-istat fiss, DM-3411 jirrapreżenta 23.1 % sa 47.
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.
Maltese: Fil-grupp ta' brexpiprazole 4 mg/jum, il-bidla massima medja aġġustata għall-plaċebo mil-linja bażi fl-intervall ta' QTcl kienet ta' 5.2 ms (90 % Cl: 1.5, 8.9) f'irġiel (n = 48) u 15.
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
Maltese: RXULTI 0.25 mg pilloli miksija b'rita RXULTI 0.5 mg pilloli miksija b'rita RXULTI 1 mg pilloli miksija b'rita RXULTI
English: In the same trial the active reference, quetiapine XR added for assay sensitivity only, separated from placebo.
Maltese: Fl-istess prova r-riferiment attiv, quetiapine XR kien miżjud għas-sensittività tal-assaġġ biss, isseparat mill-plaċebo.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal gallatosju, defiċjenza totali ta' lattosju jew assorbiment ħażin ta' glukosju-gallatosju m'għandhomx jieħdu dan il-prodott mediċinali.
English: Generally, these risks are greatest at the beginning of treatment with antipsychotics and during dose escalation.
Maltese: Ġeneralment, dawn ir-riskji huma l-aktar fil-bidu ta' trattament b'antipsikotiċi u waqt żieda fid-doża.
English: Tablet coat
Maltese: Kisi tal-pillola
English: Each film-coated tablet contains 48.2 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 48.2 mg lactose (bħala monoidrat).
English: In trials 1, 2 and 3 brexpiprazole was titrated as described in section 4.2 with 1 mg for 4 days, followed by 2 mg on days 5 to 7.
Maltese: Fil-provi 1, 2 u 3 brexpiprazole ġie titrat kif deskritt f'sezzjoni 4.2 b'1 mg għal 4 ijiem, segwit b'2 mg f'jiem 5 sa 7.
English: RXULTI 0.25 mg film-coated tablets brexpiprazole
Maltese: RXULTI 0.25 mg pilloli miksija b'rita brexpiprazole
English: 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.
Maltese: L-għoti fl-istess waqt ta' ketoconazole (200 mg darbtejn kuljum għal 7 ijiem), impeditur qawwi ta' CYP3A4, b'2 mg doża orali waħda ta' brexpiprazole żied l-AUC ta' brexpiprazole b'97 % u l-ebda bidla f'Cmax.
English: • allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
Maltese: • reazzjoni allerġika (eż. nefħa fil-ħalq, l-ilsien, il-wiċċ u l-griżmejn, ħakk, urtikarja),
English: 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).
Maltese: Għal pazjenti b'indeboliment moderat għal sever tal-kliewi (tneħħija tal-kreatinina CLcr < 60 mL/minuta), id-doża massima rakkomandata għandha titnaqqas għal 3 mg darba kuljum (ara sezzjoni 4.2).
English: Key secondary efficacy measure: CGI-S Mean baseline score (SD)
Maltese: Punteġġ tal linja bażi medja (SD)
English: Following oral administration, brexpiprazole decreased blood pressure and prolonged QT interval in safety pharmacology study in conscious male dog, in repeated-dose toxicity studies in male and female monkeys and in juvenile toxicity study in male and female dogs.
Maltese: Wara l-għoti orali, brexpiprazole naqqas il-pressjoni tad-demm u tawwal l-intervall QT fi studju farmakoloġiku ta' sigurtà f'kelb maskili konxju, fi studji ta' tossiċità b'doża ripetuta f'xadini maskili u feminili u fi studju ta' tossiċità ġovanili fi klieb maskili u feminili.
English: Thus, DM-3411 is considered not to contribute to the therapeutic effects of brexpiprazole.
Maltese: Għalhekk, DM-3411 hu kkonsidrat li ma jikkontribwixxix għall-effetti terapewtiċi ta' brexpiprazole.