FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Abbażi ta' stimi mill-analiżi farmakokinetika tal-popolazzjoni, metabolizzaturi estensivi ta' CYP2D6 li jirċievu kemm impedituri ta' CYP3A4 u CYP2D6 jew metabolizzaturi batuti ta' CYP2D6 li jirċievu impedituri qawwija ta' CYP3A4 huma mistennija li jkollhom żieda ta' madwar 4 darbiet sa 5 darbiet fil-konċentrazzjonijiet ta' brexpiprazole u aġġustament fid-doża għal kwart tad-doża hu rakkomandat għal dawn l-individwi (ara sezzjoni 4.2).
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]).
Maltese: Marder pożittivi, negattivi, ħsibijiet diżorganizzati, ostilità inkontrollabbli/eċċitament u ansjeta/depressjoni), u l-analiżi għal rispons (imfisser bħala titjib ta' 30 % fil-punteġġ totali ta' PANSS paragunat mal-linja bażi jew ma' punteġġ CGI-I ta' 1 [imtejjeb ħafna] jew [imtejjeb]).
English: Brexpiprazole maintained symptom control and functioning compared to placebo.
Maltese: Brexpiprazole żamm il-kontroll ta' sintomi u funzjonament meta paragunat ma' plaċebo.
English: The exposure (AUC) of brexpiprazole in women was estimated to be 25 % higher than in men (see section 4.8).
Maltese: L-esponiment (AUC) ta' brexpiprazole fin-nisa kien stmat li hu 25 % ogħla milli fl-irġiel (ara sezzjoni 4.8).
English: The incidence of akathisia in the short-term, controlled trials (5.4 %) was similar to the incidence in the long-term, open-label trials (5.7 %).
Maltese: L-inċidenza ta' akatisja fil-provi fuq terminu ta' żmien qasir, b'kontrolli (5.4 %) kienet simili għallinċidenza ta' provi fuq terminu ta' żmien twil b'tikketta tidher (5.7 %).
English: In embryo-foetal developmental toxicity studies, brexpiprazole was not teratogen in orally treated rats up to exposure levels (based on data in non-pregnant rats) clinically achieved at MRHD.
Maltese: Fi studji ta' tossiċità embrijo-fetali tal-iżvilupp, brexpiprazole ma kienx teratoġeniku f'firien trattati oralment sa livelli ta' esponimenti (abbażi tad-dejta f'frien li ma kinux tqal) miksuba klinikament b'MHRD.
English: Drug withdrawal syndrome neonatal (see section 4.6)
Maltese: tiżmim talmediċina fit tarbija li għadha kif titwieled (ara sezzjoni 4.6)
English: Significant increased pre-implantation losses were observed at 4.1-fold the clinical exposure at MRHD.
Maltese: Żidiet sinjifikanti ogħla ta' telf qabel l-impjantazzjoni kienu osservati 4.1 drabi lesponiment kliniku b'MRHD.
English: The maximum recommended dose in patients with moderate to severe hepatic impairment (Child-Pugh score ≥ 7) is reduced to 3 mg once daily (see section 5.2).
Maltese: Id-doża massima rakkomandata f'pazjenti b'funzjoni tal-fwied indebolita b'mod moderat għal sever (punteġġ Child-Pugh ≥ 7) hi mnaqqsa għal 3 mg darba kuljum (ara sezzjoni 5.2).
English: • increased levels of the hormone prolactin, or have a tumour in your pituitary gland.
Maltese: • livelli ogħla tal-ormon prolaktin, jew għandek tumur fil-glandola pitwitarja tiegħek.
English: Based on in vitro data brexpiprazole showed little to no inhibition of other CYP450 isozymes.
Maltese: Abbażi ta' dejta in vitro brexpiprazole wera ftit jew xejn impediment ta' isoenzimi oħra ta' CYP450.
English: The pharmacology of brexpiprazole is believed to be mediated by a modulatory activity at the serotonin and dopamine systems that combines partial agonist activity at serotonergic 5-HT1A and at dopaminergic D2 receptors with antagonist activity at serotonergic 5-HT2A receptors, with similar high affinities at all of these receptors
Maltese: Il-farmakoloġija ta' brexpiprazole hi meqjusa li ssir permezz tal-attività modulari fis-sistemi ta' serotonin u dopamine li jikkombinaw attività agonista parzjali fir-riċettaturi serotonerġiċi f'5-HT1A u dopaminerġiċi D2 b'attività antagonista fir-riċettaturi serotonerġiċi 5-HT2A b'affinità għolja simili għal dawn ir-riċettaturi kollha (Ki: 0.1 nM sa 0.5 nM) Brexpiprazole juri wkoll attività antagonista fir-riċettaturi noradrenerġiċi α1B/2C b'affinità fl-istess firxa sottonanomolari ta' Ki (Ki: 0.2 nM sa 0.6 nM).
English: In rabbit, vertebral malformations were seen in 3 foetuses from 2 litters at maternally toxic brexpiprazole oral doses corresponding to exposure approximately 16.5-fold the clinical exposure at MRHD.
Maltese: Fil-fenek, malformazzjonijiet vertebrali ġew osservati fi 3 feti minn 2 btien f'dożi orali ta' brexpiprazole maternament tossiċi li jikkorispondu għal esponiment ta' madwar 16.5 drabi r-rispons kliniku b'MRHD.
English: Each film-coated tablet contains 46.4 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 46.4 mg lactose (bħala monoidrat).
English: Akathisia Dizziness Tremor Sedation
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: Switching from other antipsychotics to brexpiprazole When switching from other antipsychotics to brexpiprazole gradual cross-titration should be considered, with gradual discontinuation of the previous treatment while brexpiprazole treatment is initiated.
Maltese: Meta taqleb minn antipsikotiċi oħrajn għal brexpiprazole titrazzjoni inkroċjata gradwali għandha tiġi kkonsidrata, b'waqfa gradwali tat-trattament preċedenti waqt li jinbeda brexpiprazole.
English: • certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors e.g. indinavir, ritonavir),
Maltese: • ċerti mediċini biex jittrattaw infezzjoni ta' HIV (bħal efavirenz, nevirapine, u impedituri ta'
English: RXULTI 4 mg film-coated tablets brexpiprazole
Maltese: RXULTI 4 mg pilloli miksija b'rita brexpiprazole
English: Each film-coated tablet contains 45.4 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 45.4 mg lactose (bħala monoidrat).
English: 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.
Maltese: Fit-tliet provi ta' terminu ta' żmien qasir b'doża fissa (provi 1, 2 u 3), individwi ġew magħżula b'mod każwali għal brexpiprazole 2 mg darba kuljum, 4 mg darba kuljum jew plaċebo.
English: • akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),
Maltese: • akatisja (sensazzjoni skomda ta' irrikwitezza interna u ħtieġa qawwija li tiċċaqlaq b'mod kostanti),
English: Each film-coated tablet contains 0.25 mg brexpiprazole.
Maltese: Kull pillola miksija b'rita fiha 0.25 mg brexpiprazole.
English: • medicines having an effect on the central nervous system.
Maltese: • mediċini li għandhom effett fuq is-sistema nervuża ċentrali.
English: RXULTI 0.25 mg film-coated tablets Each film-coated tablet contains 0.25 mg brexpiprazole.
Maltese: RXULTI 0.25 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 0.25 mg brexpiprazole.
English: Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia.
Maltese: Fatturi ta' riskju possibbli għal lewkopenija/newtropenija jinkludu ċelluli bojod taddemm (WBC) baxx minn qabel jew storja ta' lewkopenija/newtropenija mqanqla minn mediċina.
English: RXULTI 3 mg film-coated tablets brexpiprazole
Maltese: RXULTI 3 mg pilloli miksija b'rita brexpiprazole
English: RXULTI 3 mg film-coated tablets EU/1/18/1294/006 (28 film-coated tablets)
Maltese: RXULTI 3 mg pilloli miksija b'rita EU/1/18/1294/006 (28 pilloli miksija b'rita)
English: In trial 5, a long-term trial designed to assess the maintenance of effect of brexpiprazole by assessing the delay in time to impending relapse of schizophrenia, patients with schizophrenia, who responded to treatment with brexpiprazole 1 mg/day to 4 mg/day, were stabilised over 12 weeks to 36 weeks, and then randomised in a double-blind manner to either continue treatment with the stabilisation dose of brexpiprazole (n = 96) or to receive placebo (n = 104) for 52 weeks or until relapse occurred.
Maltese: Fi prova 5, prova fuq terminu ta' żmien twil maħsuba biex taċċessa ż-żamma tal-effett ta' brexpiprazole billi jiġi valutat id-dewmien fi żmien għal rikaduta imminenti ta' skiżofrenija, pazjenti bi skiżofrenija li rrispondew għal trattament bi brexpiprazole 1 mg/jum sa 4 mg/jum, kienu stabilizzati fuq 12-il ġimgħa sa 36 ġimgħa, u mbagħad magħżula b'mod każwali b'mod double-blind biex jew jissoktaw it-trattament bid-doża ta' stabilizzazzjoni ta' brexpiprazole (n = 96) jew jirċievu plaċebo (n = 104) għal 52 ġimgħa jew sakemm kien hemm rikaduta.
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.
Maltese: Għad-dardir, l-inċidenza globali fil-grupp ta' 2 mg sa 4 mg brexpiprazole kienet ta' 2.3 % fi provi b'kontrolli fuq terminu ta' żmien qasir meta mqabbla ma' 2.0 % fil-plaċebo; għal remettar dawn linċidenzi kienu 1.0 % fil-grupp trattat bi brexpiprazole meta mqabbla ma' 1.2 % fil-grupp tal-plaċebo.
English: RXULTI 1 mg film-coated tablets brexpiprazole
Maltese: RXULTI 1 mg pilloli miksija b'rita brexpiprazole
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
Maltese: L-effikaċja kienet murija fi prova 1 kemm għal brexpiprazole 2 mg/jum u 4 mg/jum u replikata fi prova 2 għal brexpiprazole 4 mg/jum biss u fi prova 3 għal brexpiprazole 2 mg/jum biss.
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.
Maltese: • irregolaritajiet fir-ritmu tal-qalb li jistgħu jkunu dovuti għal impulsi newroloġiċi abnormali filqalb, qari mhux normali waqt eżami tal-qalb (ECG), titwil tal-QT - mhux magħruf kemm hemm persuni affettwati.
English: Patients with a pre-existing low WBC or a history of drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and brexpiprazole should be discontinued at the first sign of decline in WBC, in the absence of other causative factors.
Maltese: WBC baxx minn qabel jew bi storja ta' lewkopenija/newtropenija mqanqla minn mediċina għandhom jkollhom l-għadd totali tad-demm (CBC - complete blood count) monitorat ta' spiss matul l-ewwel ftit xhur ta' terapija u brexpiprazole għandu jitwaqqaf mal-ewwel sinjal ta' tnaqqis fil-WBC, fin-nuqqas ta' fatturi kawżattivi oħrajn.
English: In placebo-controlled trials with some antipsychotics in elderly patients with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks), including fatalities, compared to placebo-treated subjects.
Maltese: Fi provi bil-plaċebo bħala kontroll ma' xi antipsikotiċi f'pazjenti anzjani b'dimenzja, kien hemm inċidenza ogħla ta' reazzjonijiet ċerebrovaskulari avversi (inċidenti ċerebrovaskulari u attakki iskemiċi temporanji), li jinkludu fatalitajiet, meta mqabbla ma' individwi trattati bi plaċebo.
English: RXULTI 4 mg film-coated tablets EU/1/18/1294/007 (28 film-coated tablets)
Maltese: RXULTI 4 mg pilloli miksija b'rita EU/1/18/1294/007 (28 pilloli miksija b'rita)
English: Seizures
Maltese: Urtikarja
English: RXULTI 1 mg film-coated tablets Each film-coated tablet contains 1 mg brexpiprazole.
Maltese: RXULTI 1 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 1 mg brexpiprazole.
English: The safety and efficacy of brexpiprazole in the treatment of schizophrenia in patients aged 65 years and older have not been established (see sections 4.4 and 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' brexpiprazole fit-trattament ta' skiżofrenija f'pazjenti li għalqu 65 sena u aktar għadhom ma ġewx stabbiliti (ara sezzjonijiet 4.4 u 5.2).
English: RXULTI 0.25 mg film-coated tablets EU/1/18/1294/001 (28 film-coated tablets)
Maltese: RXULTI 0.25 mg pilloli miksija b'rita EU/1/18/1294/001 (28 pilloli miksija b'rita)
English: RXULTI 4 mg film-coated tablets Each film-coated tablet contains 4 mg brexpiprazole.
Maltese: RXULTI 4 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 4 mg brexpiprazole.
English: RXULTI 0.5 mg film-coated tablets brexpiprazole
Maltese: RXULTI 0.5 mg pilloli miksija b'rita brexpiprazole
English: Placebo Brexpiprazole (2 mg/day)* 113 96.55 Brexpiprazole (4 mg/day) Placebo Brexpiprazole (2 mg/day to 4 mg/day
Maltese: Brexpiprazole* (2 mg/jum sa 4 mg/j um)b
English: Dysphagia
Maltese: Dijarea
English: Although no specific pharmacokinetic study was conducted, population pharmacokinetic evaluation revealed no evidence of clinically significant race-related differences in the pharmacokinetics of brexpiprazole.
Maltese: Għalkemm ma sar l-ebda studju farmakokinetiku speċifiku, l-evalwazzjoni farmakokinetika talpopolazzjoni ma wriet l-ebda evidenza ta' differenzi klinikament sinjifikanti marbuta mar-razza filfarmakokinetiċi ta' brexpiprazole.
English: Caution should be exercised when brexpiprazole is prescribed in patients with known cardiovascular disease, family history of QT prolongation, electrolyte imbalance or in concomitant use with other medicinal products thought to prolong the QT interval (see sections 4.8 and 5.1).
Maltese: Kawtela għandha tiġi eżerċitata meta brexpiprazole jingħata bi preskrizzjoni lil pazjenti b'mard kardjovaskulari, bi storja medika filfamilja ta' titwil tal-QT, żbilanċ fl-elettroliti jew b'użu fl-istess waqt ma' prodotti mediċinali oħra maħsubin li jtawwlu l-intervall QT (ara sezzjonijiet 4.8 u 5.1).
English: RXULTI 0.5 mg film-coated tablets EU/1/18/1294/002 (28 film-coated tablets)
Maltese: RXULTI 0.5 mg pilloli miksija b'rita EU/1/18/1294/002 (28 pilloli miksija b'rita)
English: LS mean change from baseline (SE)
Maltese: Bidla medja LS mil-linja bażi (SE)
English: • tooth decay or cavities (dental caries),
Maltese: • karje jew kavitrajiet tas-snien,
English: RXULTI 3 mg film-coated tablets Each film-coated tablet contains 3 mg brexpiprazole.
Maltese: RXULTI 3 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 3 mg brexpiprazole.
English: The recommended target dose range is 2 mg to 4 mg once daily.
Maltese: Id-doża fil-mira rakkomandata hi ta' 2 mg sa 4 mg darba kuljum.
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.
Maltese: Brexpiprazole mogħti oralment ma żiedx l-inċidenza ta' tumuri fi studju karċinoġeniku ta' sentejn kemm f'firien irġiel u nisa u fi ġrieden irġiel f'esponimenti li kienu sa 4.4 darbiet u 3.1 darbiet l-MRHD.
English: Each film-coated tablet contains 1 mg brexpiprazole.
Maltese: Kull pillola miksija b'rita fiha 1 mg brexpiprazole.
English: Overall in the brexpiprazole clinical development program for schizophrenia, one death due to suicide, considered not drug related by the investigator, occurred.
Maltese: Globalment, fil programm ta' żvilupp kliniku għal brexpiprazole għal skiżofrenija, kien hemm mewt waħda dovutagħal suwiċidju, ikkonsidrata mhux relatata mal-mediċina mill-investigatur.
English: RXULTI 0.5 mg film-coated tablets Each film-coated tablet contains 0.5 mg brexpiprazole.
Maltese: RXULTI 0.5 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 0.5 mg brexpiprazole.
English: Each film-coated tablet contains 0.5 mg brexpiprazole.
Maltese: Kull pillola miksija b'rita fiha 0.5 mg brexpiprazole.
English: Known CYP2D6 poor metabolisers
Maltese: Metabolizzaturi batuti ta' CYP2D6
English: In the flexible-dose trial 4, at week 6, subjects in the brexpiprazole treatment group had numerically greater improvements on PANSS total score than the subjects in the placebo group, although, the difference at week 6 did not reach statistical significance for the primary efficacy analysis (p = 0.0560; see table 2).
Maltese: Fil-prova b'doża flessibbli 4, f'ġimgħa 6, individwi fil-grupp ta' trattament ta' brexpiprazole kellhom titjib numerikament akbar fil-punteġġ totali ta' PANSS mill-individwi fil-grupp tal-plaċebo, għalkemm id-differenza f'ġimgħa 6 ma laħaqtx livell li kien statistikament sinjifikanti għall-analiżi ta' effikaċja primarja (p = 0.0560; ara tabella 2).
English: RXULTI 4 mg film-coated tablets White, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 4 one side.
Maltese: RXULTI 4 mg pilloli miksija b'rita Bajda, tonda, b'dijametru ta' 6 mm, konvessa baxxa u bit-tarf imċanfar, b'BRX u 4 imnaqqxin fuq naħa waħda.
English: Each film-coated tablet contains 2 mg brexpiprazole.
Maltese: Kull pillola miksija b'rita fiha 2 mg brexpiprazole.
English: 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).
Maltese: Brexpiprazole għandu effett żgħir sa moderat fuq il-ħila biex issuq u tħaddem magni minħabba leffetti potenzjali fuq is-sistema nervuża ċentrali, bħal sedazzjoni u sturdament li huma reazzjonijiet avversi komuni għall-mediċina (ara sezzjoni 4.8).
English: Other medicines and RXULTI
Maltese: Kif taħżen RXULTI
English: RXULTI 0.25 mg film-coated tablets
Maltese: RXULTI 0.25 mg pilloli miksija b'rita
English: Patients taking CYP2D6 inhibitors and/or CYP3A4 inhibitors
Maltese: Pazjenti li qed jieħdu impedituri ta' CYP2D6 u/jew impedituri ta' CYP3A4
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).
Maltese: Għal pazjenti b'indeboliment moderat għal sever tal-fwied (Child-Pugh Klassijiet B, u Ċ), id-doża massima rakkomandata hi mnaqqsa għal 3 mg darba kuljum (ara sezzjoni 4.2).
English: RXULTI 2 mg film-coated tablets Each film-coated tablet contains 2 mg brexpiprazole.
Maltese: 2 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 2 mg brexpiprazole.
English: • combination of fever, sweating, muscle stiffness, and drowsiness or sleepiness.
Maltese: • kombinazzjoni ta' deni, tegħreq, riġidità fil-muskoli u ħedla jew ngħas.
English: RXULTI 3 mg film-coated tablets Iron oxide E 172 (red, black)
Maltese: Iron oxide E 172 (aħmar, iswed)
English: No safety margins based on AUC0-24 h at the Maximum Recommended Human Dose (MRHD) of 4 mg/day could be derived in both female and male rats and monkey.
Maltese: L-ebda marġini ta' sigurtà fuq l-AUC0-24 h fidDoża Massima Rakkomandata għall-Bniedem (MRHD - Maximum Recommended Human Dose) ta' 4 mg/jum ma tista' tiġi derivata kemm fuq firien u xadini nisa u rġiel.
English: Brexpiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medicinal products) or hypertension (including accelerated or malignant).
Maltese: Brexpiprazole għandu jintuża b'kawtela f'pazjenti magħrufin li għandhom mard kardjovaskulari (storja medika ta' infart mijokardjali jew mard iskemiku tal-qalb, insuffiċjenza tal-qalb jew abnormalitajiet fit-trasmissjoni), mard ċerebrovaskulari, kundizzjonijiet li jippredisponu pazjenti għal pressjoni baxxa (deidrazzjoni, ipovolemja, u trattament bi prodotti mediċinali kontra l-pressjoni għolja) jew pressjoni għolja (li jinkludi dik aċċelerata jew malinna).
English: Light orange, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.5 on one side.
Maltese: Oranġjo ċara, tonda, b'dijametru ta' 6 mm, konvessa baxxa u bit-tarf imċanfar, b'BRX u 0.5 imnaqqxin fuq naħa waħda.
English: 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).
Maltese: Jekk l-impeditur/indutturi ta' CYP3A4 jew l-impeditur ta' CYP2D6 jiġu rtirati, id-doża għandha mnejn tkun trid tiġi lura għad-doża oriġinali (ara sezzjoni 4.5).
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.
Maltese: Metabolizzaturi batuti ta' CYP2D6 Aġġustamenti dożali għal nofs id-dożi rakkomandati huma meħtieġa għal pazjenti bi stat magħruf batut ta' metabolizzatur ta' CYP2D6.
English: Elderly
Maltese: Fatturi
English: Each film-coated tablet contains 4 mg brexpiprazole.
Maltese: Kull pillola miksija b'rita fiha 4 mg brexpiprazole.
English: Each film-coated tablet contains 3 mg brexpiprazole.
Maltese: Kull pillola miksija b'rita fiha 3 mg brexpiprazole.
English: RXULTI can help to keep the symptoms under control and to prevent relapse as you continue treatment.
Maltese: Dawn is-sintomi jistgħu jseħħu kmieni waqt it-trattament.
English: 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.
Maltese: Il-punt sekondarju ewlieni fil-provi 1, 2, u 4 kien l-Impressjoni Globali
English: It should be noted that in vivo preclinical studies have shown that at clinically relevant plasma exposures of brexpiprazole, DM-3411 brain exposures were below the detection limit.
Maltese: Għandu jiġi nnotat li studji in vivo ta' qabel l-użu kliniku wrew li f'esponimenti ta' brexpiprazole fil-plażma klinikament rilevanti, l-esponiment fil-moħħ ta' DM-3411 kien inqas mil-livell intraċċabbli.
English: Brexpiprazole is absorbed after administration of the tablet, with peak plasma concentrations occurring within 4.0 hours after single dose administrations; the absolute oral bioavailability of the tablet formulation is 95.1 %.
Maltese: Brexpiprazole jiġi assorbit wara l-għoti tal-pillola, bl-ogħla konċentrazzjonijiet fil-plażma jintlaħqu fi żmien 4.0 sigħat wara l-għoti ta' doża waħda, bil-bijodisponibilità assoluta orali tal-formulazzjoni talpillola tkun 95.1 %.
English: Adjusted dose
Maltese: Tqala u treddigħ
English: Clinical monitoring of weight and lipid profile is recommended at baseline and during treatment.
Maltese: Monitoraġġ kliniku tal-piż u l-profil ta' lipidi hu rakkomandat fil-linja bażi u waqt it-trattament.
English: Not known
Maltese: Ilma purifikat
English: Each film-coated tablet contains 47.4 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 47.4 mg lactose (bħala monoidrat). RXULTI
English: RXULTI 0.25 mg film-coated tablets Iron oxide E 172 (yellow, red, black)
Maltese: Iron oxide E 172 (isfar, aħmar, iswed)
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Orthostatic hypotension
Maltese: • sintomi relatati mal-emboli tad-demm fil-vini b'mod speċjali fir-riġlejn (sintomi jinkludu nefħa,
English: RXULTI 2 mg film-coated tablets brexpiprazole
Maltese: 2 mg pilloli miksija b'rita brexpiprazole
English: Brexpiprazole also shows antagonist activity at noradrenergic α1B/2C receptors with affinity in the same sub-nanomolar Ki range (Ki: 0.2 nM to 0.6 nM).
Maltese: Pazjenti b'newtropenija severa (għadd assolut ta' newtrofili < 1,000/mm3) għandhom iwaqqfu brexpiprazole u jkollhom il-WBC segwit sakemm jirkupraw.
English: Age
Maltese: Akatisja