FrancophonIA/ELRC3.0 huggingface dataset:
English: Up to Week 52, 11 (10.7%) and 8 (7.8%) patients developed 12 and 8 anal fistula adverse events in the Alofisel and control groups, respectively, none of these being of severe intensity.
Maltese: 7%) u 8 (7.8%) pazjenti żviluppaw 12 u 8 avvenimenti avversi tal-fistula anali fil-grupp ta' Alofisel u fil-grupp ta' kontroll rispettivament, bl-ebda wieħed minn dawn ma jkun ta' intensità severa.
English: Reproductive and developmental toxicity studies have not been performed for darvadstrocel because preclinical biodistribution studies indicated no migration and integration of eASC into reproductive organs following administration of eASC via different routes.
Maltese: L-istudji dwar it-tossiċità riproduttiva u tal-iżvilupp ma sarux għal darvadstrocel minħabba li studji dwar il-bijodistribuzzjoni preklinika ma indikaw l-ebda migrazzjoni jew integrazzjoni tal-eASC fl-organi riproduttivi wara l-amministrazzjoni tal-eASC permezz ta' rotot differenti.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Alofisel in one or more subsets of the paediatric population in the treatment of anal fistula (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Alofisel f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-kura tal-fistula anali (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Alofisel will be used after adequate preparation of the fistula, see section 3.
Maltese: Alofisel jintuża wara preparazzjoni b'mod adegwat tal-fistula, ara sezzjoni 3.
English: Do not give this medicine to children and adolescents (i.e. aged under 18 years) because the potential benefits and risks are unknown.
Maltese: Tagħtix din il-mediċina lil tfal u adolexxenti (jiġifieri taħt l-età ta' 18-il sena) minħabba li l-benefiċċji u r-riskji potenzjali mhumiex magħrufa.
English: The MAH shall ensure that in each Member State where Alofisel is marketed, all healthcare professionals who are expected to handle and administer Alofisel have access to the educational package for health professionals.
Maltese: Il-MAH għandu jassigura li f'kull Stat Membru fejn Alofisel jitqiegħed fis-suq, il-professjonisti kollha tal-kura tas-saħħa li huma mistennija li joħorġu riċetta u jamministraw Alofisel, ikollhom aċċess għall-pakkett edukattiv għall-professjonisti fil-kura tas-saħħa.
English: c) Remove the cap from the vial, gently turn the vial upside down, and gently aspirate the whole content using a syringe with a conventional needle no thinner than 22G (see section 4.4).
Maltese: c) Neħħi t-tap mill-kunjett, bil-mod dawwar il-kunjett rasu ‘l isfel u bil-mod aspira l-kontenut kollu bl-użu ta' siringa b'labra konvenzjonali mhux irqaq minn 22G (ara Sezzjoni 4.4.
English: The vials are placed inside a cardboard box.
Maltese: Żomm il-prodott fil-kartuna ta' barra.
English: The active ingredient of Alofisel is darvadstrocel which consists of stem cells which are taken from the fat tissue of a healthy adult donor (so-called allogenic stem cells) and then grown in a laboratory.
Maltese: L-ingredjent attiv ta' Alofisel hu darvadstrocel li jikkonsisti f'ċelloli staminali li jittieħdu mit-tessut tax-xaħamta'donaturadultb'saħħtu('lhekkimsejħaċellolistaminalialloġeniċi)umbagħad imkabbra f'laboratorju.
English: *Conditioning reactions occurring up to seven days after the fistula cleaning for treatment administration.
Maltese: *Reazzjonijiet tal-kundizzjonament li seħħew sa sebat ijiem wara t-tindif tal-fistula biex jingħatat-trattament.
English: This was a randomised, double blind, parallel group, placebo-controlled, multicentre clinical trial to assess efficacy and safety of Alofisel for the treatment of complex perianal fistulas in Crohn's disease patients.
Maltese: Din kienet prova klinikarandonised, double-blind, bi grupp parallel, ikkontrollat bi plaċebo, f'ħafna ċentri biex tiġi vvalutata l-effikaċja u s-sigurtà ta' Alofisel għall-kura ta' fistuli perianali kumplessi f'pazjenti bil-marda ta' Crohn. Ġew randomizzati 212-il pazjent, u 205 pazjenti rċevew injezzjoni lokali b'Alofisel ta' 120 miljun ċellola jew bi plaċebo b'disinn 1:1.
English: GLASS VIAL
Maltese: TAGĦRIF
English: For injection in the fistula tract tissue in a surgical environment under anaesthesia (general or regional (see section 4.4)) as described below.
Maltese: Għal injezzjoni fit-tessut tal-passaġġ tal-fistula f'ambjent kirurġiku taħt anesteżija (ġenerali jew reġjonali (ara Sezzjoni 4.4)) kif deskritt hawn taħt.
English: Adult stem cells are a special type of cells found in many adult tissues, whose primary role is the repair of the tissue in which they are found.
Maltese: Ċelloli staminali adulti huma tip speċjali ta' ċelloli li jinsabu f'ħafna tessuti adulti, li r-rwol primarju tagħhom hu t-tiswija tat-tessut li jinsabu fih.
English: After the cells have been resuspended (by gentle manual tapping), Alofisel is a white to yellowish homogenous suspension.
Maltese: Wara li ċ-ċelloli jkunu ġew sospiżi mill-ġdid (permezz ta' tektik manwali ħafif), Alofisel hu suspensjoni omoġena bajda fl-isfar.
English: Local anaesthesia is not recommended due to the unknown effect of local anaesthetics on the injected cells (see section 4.2).
Maltese: L-anestesija lokali mhix rakkomandata minħabba l-effett mhux magħruf tal-anestetiċi lokali fuq iċ-ċelloli injettati (ara Sezzjoni 4.2).
English: • Instructions how to handle medication errors and transmission of infectious agents
Maltese: • Struzzjonijiet dwar kif għandhom jiġu trattati żbalji fil-medikazzjoni u t-trażmissjoni ta' aġenti infettivi.
English: Alofisel may contain traces of benzylpenicillin or streptomycin (antibiotics).
Maltese: Qabel it-tattament b'Alofisel, inti tingħata anestetiku.
English: It may harm them,
Maltese: Ġeneru sesswali
English: • The active substance is brexpiprazole.
Maltese: • Is-sustanza attiva hi brexpiprazole.
English: DK 2500 Valby Denmark
Maltese: DK 2500 Valby Id-Danimarka
English: Tablet coat: Hypromellose, talc, titanium dioxide.
Maltese: Hypromellose, talc, titanium dioxide.
English: Confidence interval Treatment statistically significantly superior to placebo a
Maltese: Confidence interval (Intervall ta' kunfidenza) Trattament statistikament sinjifikanti superjuri għal plaċebo a
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code N05AX16
Maltese: Grupp fatmakoterapewtiku Psikolettiċi, antipsikotiċi oħrajn, Kodiċi ATC N05AX16
English: Effects on QT
Maltese: Effetti fuq QT
English: Treatment group n
Maltese: Grupp ta' trattament n
English: Lactose monohydrate, maize starch, microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, purified water.
Maltese: Lactose monohydrate, lamtu tal-qamħirrun, microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate, ilma purifikat.
English: Results of a sensitivity analysis using placebo based multiple imputation (PMI) were consistent with the primary analysis.
Maltese: Riżultati ta' analiżi sensittiva permezz ta' imputazzjoni multipla abbażi ta' plaċebo (PMI - placebo based multiple imputation) kienu konsistenti mal-analiżi primarja.
English: LS mean differencea (95 % CI)
Maltese: Differenza medjaa LS 95 % Cl)
English: The categorisation of blood prolactin increased is based on Potentially Clinically Relevant (PCR) criteria of > 1 × upper limit of normal (ULN).
Maltese: Klinikament (Potentially clinically relevant, PCR) ta' > 1 × limitu ta' fuq tan-normal (ULN).
English: Body temperature
Maltese: Temperatura tal-ġisem
English: The trials included 2,690 patients with the age of 18 years to 65 years.
Maltese: Il-provi kienu jinkludu 2,690 pazjent mill-etajiet ta' 18-il sena sa 65 sena.
English: • antifungal medicines (such as ketoconazole, itraconazole),
Maltese: • mediċini ta' kontra l moffa (bħal ketoconazole, itraconazole),
English: Blood creatine phosphokinase increased
Maltese: Żieda ta' creatine phosphokinase fiddemm
English: Česká republika Lundbeck Česká republika s.r.o.
Maltese: Lundbeck Česká republika s.r.o.
English: Brexpiprazole is predominantly metabolised by CYP3A4 and CYP2D6.
Maltese: Brexpiprazole huwa prinċipalment metabolizzat b'CYP3A4 and CYP2D6.
English: Leukopenia, neutropenia and agranulocytosis
Maltese: Lewkopenija, newtropenija u agranuloċitosi
English: Immune system disorders
Maltese: Disturbi fs-sistema immuni
English: • muscle pain,
Maltese: • uġigħ muskolari,
English: The CGI-S was also assessed in trials 3 and 5 as secondary endpoint.
Maltese: Is-CGI-S kien assessjat ukoll fil-provi 3 u 5 bħala punt finali sekondarju.
English: At week 52 brexpiprazole (13.5 %) reduced the risk of impending relapse by 71 % compared with placebo (38.5 %).
Maltese: F'ġimgħa 52 brexpiprazole (13.5 %) naqqas ir-riskju ta' rikaduta imminenti b'71 % meta mqabbel ma' plaċebo (38.5 %).
English: Trial 4 assessed the efficacy, safety, and tolerability of brexpiprazole in a flexible dose range of 2 mg/day to 4 mg/day and 400 mg to 800 mg quetiapine extended release (XR) for assay sensitivity.
Maltese: Prova 4 assessjat l-effikaċja, is-sigurtà u t-tolerabilità ta' brexpiprazole fil-firxa ta' doża flessibbli ta' 2 mg/jum sa 4 mg/jum u 400 mg sa 800 mg quetiapine ta' rilaxx estiż (XR, extended release) għal assaġġ ta' sensittività.
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.
Maltese: Abbażi ta' studi in vivo, brexpiprazole la huwa substrat u lanqas mhu impeditur ta' trasportaturi tal-effluss, bħal Multi Drug Resistance (MDR) 1 (P-gp) u BRCP.
English: Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292
Maltese: Otsuka Pharmaceutical Netherlands B.V.
English: Blood prolactin increased1
Maltese: prolaktin fiddemm1
English: A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotics.
Maltese: Sindrome ta' movimenti diskinetiċi, involontarji, u potenzjalment irriversibbli jista' jiżviluppa f'pazjenti trattati b'antipsikotiċi.
English: The volume of distribution of brexpiprazole following intravenous administration is high (1.56 L/kg ± 0.418 L/kg), indicating extravascular distribution.
Maltese: Il-volum ta' distribuzzjoni ta' brexpiprazole wara l-għoti ġol-vina huwa għoli (1.56 L/kg ± 0.418 L/kg), li jindika distribuzzjoni estravaskulari.
English: Brexpiprazole does not affect absorption of medicinal products that are substrates of Breast Cancer Resistance Protein transporter (BCRP) and P-glycoprotein (P-gp) transporter.
Maltese: Brexpiprazole ma jaffetwax l-assorbiment ta' prodotti mediċinali li huma substrati tat-trasportatur tal-Proteina ta' Reżistenza għall-Kanċer tas-Sider (BCRP - Breast Cancer Resistance protein) u t-trasportatur ta' P-glikoproteina.
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Maltese: Manifestazzjonijiet kliniċi ta' NMS huma iperpiressja, riġidità muskolari, stat tal-moħħ alterat u evidenza ta' instabilità awtonomika (polz jew pressjoni taddemm irregolari, takikardja, dijaforesi u disritmija kardijaka).
English: RXULTI 0.25 mg, 0.5 mg, 2 mg, 3 mg and 4 mg film-coated tablets 28 film-coated tablets in Aluminium/PVC blisters.
Maltese: RXULTI 0.25 mg, 0.5 mg, 2 mg, 3 mg and 4 mg pilloli miksija b'rita 28 pilloli miksija b'rita f'folji tal-Aluminju/PVC.
English: Extrapyramidal Symptoms (EPS)
Maltese: Sintomi estrapiramidali (EPS - extrapyramidal symptoms)
English: Environmental risk assessment (ERA)
Maltese: Valutazzjoni tar-riskju ambjentali (ERA)
English: Impulse-control disorders
Maltese: Disturbi fil-kontroll ta' impulsi
English: All ADRs are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: L-ADRs kollha huma elenkati skont il-klassi tas-sistema tal-organi (SOC - system organ class) u l-frekwenza; komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Brexpiprazole is an atypical antipsychotic agent.
Maltese: Brexpiprazole huwa aġent antipsikotiku atipiku.
English: Mean dose 3.5 mg/day
Maltese: Doża medja 3.5 mg/jum
English: Administer a quarter of the recommended dose
Maltese: Amministra kwart id-doża rakkomandata
English: • antibiotics to treat bacterial infections (such as clarithromycin),
Maltese: • antibijotiċi użati għal trattament ta' infezzjonijiet batterjali (bħal clarithromycin),
English: Apparent oral clearance of brexpiprazole tablet after once daily administration is 19.8 (± 11.4) mL/h/kg.
Maltese: It-tneħħija orali apparent tal-pillola brexpiprazole wara l-għoti darba kuljum hi ta' 19.8 (± 11.4) mL/h/kg.
English: Oesophageal dysmotility and aspiration have been associated with antipsychotic use.
Maltese: Dismotilità esofaġeali u aspirazzjoni ġew assoċjati ma' użu antipsikotiku.
English: LS mean differencea, b (95 % CI)
Maltese: Differenza medja LSa, b 95 % Cl)
English: CI
Maltese: JIS
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.
Maltese: LS Medju, CI 95%, u valuri p għal provi individwali kienu derivati minn analiżi MMRM (Mixed effect Model Repeat Measurement - Mudell ta' effett Imħallat b'Kejl Ripetut) kif ġej: effetti fissi tas-sit, trattament, vista u interazzjoni bi trattament mal-vista, b'linja bażi u b'interazzjoni b'linja bażi mal-vista bħala kovarjanti.
English: During the stabilisation, brexpiprazole improved clinical symptomology (as assessed by PANSS, CGI-S and CGI-I, [Analysis of Covariance - ANCOVA Last Observation Carried Forward - LOCF]) and functioning (as assessed by Global Assessment of Functioning (GAF) [ANCOVA LOCF]).
Maltese: Forward - L-aħħar osservazzjoni miġjuba 'l quddiem - LOCF]) u funzjonament (kif assessjat b'Assessjar Globali ta' Funzjonament (GAF)(ANCOVA LOCF]).
English: Based on results of in vitro studies, brexpiprazole is unlikely to cause clinically important pharmacokinetic interactions with medicinal products metabolised by cytochrome P450 enzymes.
Maltese: Abbażi ta' riżultati minn studji in vitro, brexpiprazole mhux mistenni li jikkawża interazzjonijiet farmakokinetiċi klinikament importanti ma' prodotti mediċinali metabolizzati b'enzimi ta' ċitokroma P450.
English: Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP3A4 inhibitors (itraconazole, ketoconazole, ritonavir, and clarithromycin).
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' CYP3A4 (itraconazole, ketoconazole, ritonavir u clarithromycin).
English: How to store RXULTI
Maltese: Tiħux RXULTI
English: Population PK evaluation identified gender as statistically significant covariate.
Maltese: L-evalwazzjoni PK tal-popolazzjoni identifikat il-ġeneru sesswali bħala kovarjanti statistikament sinjifikanti.
English: After single dose administration of brexpiprazole (2 mg), elderly subjects (older than 65 years) exhibited similar brexpiprazole systemic exposure (Cmax and AUC) in comparison with the adult subjects (18 years to 45 years old; see sections 4.2 and 4.4).
Maltese: Wara l-għoti ta' doża waħda ta' brexpiprazole (2 mg), pazjenti anzjani (akbar minn 65 years), urew esponiment sistematiku simili għal brexpiprazole (Cmax u AUC) paragunabbli ma' individwi adulti (18-il sena sa 45 sena; ara sezzjonijiet 4.2 u 4.4).
English: Strong/moderate CYP2D6 inhibitors with strong/moderate CYP3A4 inhibitors
Maltese: Impedituri qawwija/moderati ta' CYP2D6 ma' impedituri qawwija/moderati ta' CYP3A4
English: Angioedema Urticaria
Maltese: Anġjoedema
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c (7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: • medicines increasing an enzyme called creatine phosphokinase (CPK),
Maltese: • mediċini li jgħollu enzima li tissejjaħ creatine phosphokinase (CPK),
English: Extrapyramidal symptoms (EPS)
Maltese: Sintomi Estrapiramidali (EPS)
English: Results for the (key) secondary outcome parameter and additional endpoints were supportive of the primary endpoint.
Maltese: Ir-riżultati għall-parametru tal-eżitu sekondarju (ewlieni) u l-punti finali addizzjonali kienu jsostnu lpunt finali primarju.
English: Brexpiprazole did not show any genotoxic potential in both in vitro and in vivo studies using clinically relevant exposures.
Maltese: Brexpiprazole ma wera l-ebda potenzjal ġenotossiku kemm fi studji in vitro u in vivo meta ntużaw esponimenti klinikament rilevanti.
English: 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.
Maltese: F'individwi (n = 10) b'indeboliment sever tal-kliewi (CLcr < 30 mL/min), AUC ta' brexpiprazole orali (doża waħda ta' 3 mg) kienet mqabbla ma' individwi b'saħħithom paragunabbli ma' 68 %, waqt li s-Cmax ma nbidilx.
English: 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.
Maltese: L-inċidenza ta' akatisja fil-gruppi ta' 1 mg/jum, 2 mg/jum, u 4 mg/jum ta' brexpiprazole kienu ta' 3.0 %, 4.6 % u 6.5 %, rispettivament, meta mqabbla ma' 5.2 % ta' individwi fil-grupp tal-plaċebo.
English: The primary statistical analysis was performed using an MMRM model with MAR (Missing At Random) imputation.
Maltese: L-analiżi statistiċi primarji saru permezz ta' mudell MMRM b'imputazzjoni MAR (Missing At Random - Każwalità Nieqsa).
English: Lactose monohydrate Maize starch
Maltese: Il-qalba tal-pillola Lactose monohydrate
English: Population pharmacokinetic evaluation shows that CYP2D6 poor metabolisers have 47 % higher exposure to brexpiprazole compared to extensive metabolisers (see section 4.2).
Maltese: L-evalwazzjoni farmakokinetika tal-popolazzjoni wriet li metabolizzaturi batuti ta' CYP2D6 għandhom esponiment 47 % ogħla għal brexpiprazole meta mqabbla ma' metabolizzaturi estensivi (ara sezzjoni 4.2).
English: After multiple once daily administration of brexpiprazole, the terminal elimination half-life of brexpiprazole and its major metabolite, DM-3411, is 91.4 hours and 85.7 hours, respectively.
Maltese: Wara l-għoti multiplu darba kuljum ta' brexpiprazole, il-half-life terminali ta' eliminazzjoni ta' brexpiprazole u l-metabolit ewlieni tiegħu, DM-3411, hu 91.4 sigħat u 85.7 sigħat, rispettivament.
English: Following a single oral dose of [14C]-labelled brexpiprazole, approximately 24.6 % and 46 % of the administered radioactivity was recovered in the urine and faeces, respectively.
Maltese: Wara doża orali waħda ta' brexpiprazole tikkettat b'[14C], madwar 24.6 % u 46 % tar-radjuattività amministrata ġiet irkuprata fl-awrina u fl-ippurgar, rispettivament.
English: Summary of the safety profile The most frequently observed adverse drug reactions (ADRs) were akathisia (5.6 %) and weight gain
Maltese: L-aktar reazzjonijiet avversi għall-mediċina (ADRs - adverse drug reactions) osservati frekwentament kienu akatisja (5.6 %) u żieda fil-piż (3.9 %).
English: (Ki: 0.1 nM to 0.5 nM).
Maltese: (ara sezzjonijiet 4.5 u 5.2)
English: Studies in animals have shown decreased female fertility (see section 5.3).
Maltese: Studji fl-annimali wrew tnaqqis fil-fertilità tal-mara (ara sezzjoni 5.3).
English: A potentially fatal symptom complex referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with brexpiprazole (see section 4.4).
Maltese: Kumpless sintomatiku potenzjalment fatali riferut bħala Sindrome Malinn Newrolettiku (NMS) ġie rapportat flimkien ma' brexpiprazole (ara sezzjoni 4.4).
English: 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.
Maltese: L-effetti ta' brexpiprazole f'dożi terapewtiċi (4 mg) u sovraterapewtiċi (12 mg) fuq l-intervall QT kienu valutati f'individwi bi skiżofrenija jew b'disturb skiżoaffettiv fi prova każwali, double blind, b'kontrolli bi plaċebo u pożittivi (moxifloxacin), fi grupp parallel.
English: Higher frequencies of prolactin increased (1.5 % versus 0.60 %) were observed in females compared to males in short-term trials.
Maltese: Frekwenzi ogħla ta' prolaktin ogħla (1.5 % versus 0.60 %) kienu osservati fin-nisa meta mqabbla ma rġiel filprovi ta' terminu qasir.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder.
Maltese: Kien hemm rapporti ta' aġitazzjoni, ipertonja, ipotonja, rogħda, ħedla, distress respiratorju u disturb ta' tmigħ.
English: The efficacy and safety of brexpiprazole in the treatment of adults with schizophrenia was studied in two multi-national and one regional (Japan), 6-week, randomised, double-blind, placebo-controlled, fixed-dose clinical trials (trials 1 to 3), a multi-national, 6-week, randomised, double-blind, placebo-controlled, active reference (quetiapine), flexible-dose clinical trial (trial 4), and, one multi-national, placebo-controlled, 52-week maintenance trial (trial 5).
Maltese: L-effikaċja u s-sigurtà ta' brexpiprazole fit-trattament ta' adulti bi skiżofrenija ġie studjat f'żewġ provi kliniċi każwali, multinazzjonali, u f'reġjun wieħed (Ġappun), b'doża fissa, każwali, bi plaċebo bħala kontroll, double-blind ta' 6 ġimgħat (provi 1 sa 3), fi prova klinika multinazzjonali, każwali, doubleblind, bi plaċebo bħala kontroll, b'referenza attiva (quetiapine), fi prova klinika b'doża flessibbli ta' 6 ġimgħat (prova 4), u, fi prova waħda ta' manteniment, multinazzjonali, bi plaċebo bħala kontroll ta' 52 ġimgħa (prova 5).
English: It is important that you get your blood checked regularly as this may be fatal.
Maltese: Huwa importanti li jkollok id-demm tiegħek iċċekkjat regolarment peress li dan jista' jkun fatali.
English: les Bouillides Sophia Antipolis 06560 Valbonne France
Maltese: Elaiapharm 2881 Route des Crêtes Z.I. les Bouillides Sophia Antipolis 06560 Valbonne Franza
English: Additional signs may include increased creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Maltese: Sinjali addizzjoni jistgħu jinkludu creatine phosphokinase ogħla, mijoglobinurja (rabdomijolisi), u insuffiċjenza akuta tal-kliewi.
English: In the overall analysis brexpiprazole did not prolong the QTc interval to clinically relevant extent following therapeutic and supra-therapeutic doses (4 mg/day; n = 62 or 12 mg/day; n = 53) and no correlation has been observed between brexpiprazole concentrations and QTc prolongation.
Maltese: Fl-analiżi globali brexpiprazole ma tawwalx l-intervall ta' QTc b'mod klinikament rilevanti wara dożi terapewtiċi u sovraterapewtiċi (4 mg/jum; n = 62 or 12 mg/jum; n = 53) u l-ebda korelazzjoni ma ġiet osservata bejn il-konċentrazzjonijiet ta' brexpiprazole u t-titwil ta' QTc.