FrancophonIA/ELRC3.0 huggingface dataset:
English: The rate of death in aripiprazoletreated patients was 3.5 % compared to 1.7 % in the placebo group.
Maltese: Ir-rata ta' mwiet f'pazjenti fuq kura b'aripirazole kienet 3.5 % imqabbla ma' 1.7 % fil-grupp ta' plaċebo.
English: In a pooled analysis on lipid parameters from placebo controlled clinical trials in adults, aripiprazole has not been shown to induce clinically relevant alterations in levels of total cholesterol, triglycerides, High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL).
Maltese: lipoproteina ta' densità għolja (HDL, High Density Lipoprotein) u lipoproteina ta' densità baxxa (LDL, Low Density Lipoprotein).
English: • uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
Maltese: • movimenti mhux ikkontrollati tal-ħalq, l-ilsien u dirgħajn/riġlejn (diskinesja tardiva),
English: Alkaline phosphatase increased QT prolonged
Maltese: Żieda fl-alkaline phosphatase Titwil tal QT
English: 3 mg aspartame (E 951) and 0.1125 mg lactose per orodispersible tablet
Maltese: 3 mg aspartame (E 951) u 0.1125 mg lactose għal kull pillola li tinħall fil-ħalq
English: Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors may be expected to have similar effects and similar dose reductions should therefore be applied (see section 4.2).
Maltese: Impedituri qawwija oħra ta' CYP3A4, bħal itraconazole u impedituri tal protease ta' HIV huma mistennija li jkollhom effetti simili u tnaqqis simili fid-doża għandu, għalhekk jiġi applikat (ara sezzjoni 4.2).
English: Population pharmacokinetic evaluation showed no evidence of race-related differences on the pharmacokinetics of aripiprazole.
Maltese: Evalwazzjoni farmakokinetika tal-popolazzjoni ma wriet l-ebda evidenza ta' differenza marbuta ma' razza fuq il-farmakokinetika ta' aripiprazole.
English: Actual scores in rating scales used as secondary endpoints, including PANSS and the Montgomery-Åsberg Depression Rating Scale (MADRS) showed a significant improvement over haloperidol.
Maltese: Klassifika tad-Depressjoni (MADRS, Montgomery-Åsberg-Depression-Rating-Scale) urew titjib sinifikanti fuq haloperidol.
English: In clinical trials for the approved indications and post-marketing, both increase and decrease in serum prolactin as compared to baseline was observed with aripiprazole (section 5.1).
Maltese: Prolaktin Fi provi kliniċi bl-indikazzjonijiet approvati u wara t-tqegħid fis-suq, ġew osservati kemm żieda u kemm tnaqqis ta' prolaktin fis-serum meta mqabbla mal-linja bażi b'aripiprazole (sezzjoni 5.1).
English: In the adolescent (13 to 17 years) schizophrenia population with aripiprazole exposure of 5 mg to 30 mg up to 72 months, incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 25.6 % and 45.0 %, respectively.
Maltese: sa 17-il sena) bi skiżofrenja b'esponiment għal aripiprazole ta' 5 mg sa 30 mg għal 72 xahar, l inċidenza ta' livelli baxxi ta' prolactin fis-serum f'nisa (< 3 ng/mL) u rġiel (< 2 ng/mL) kienu ta' 25.6 % u 45.0 % rispettivament.
English: ABILIFY 7.5 mg/mL solution for injection
Maltese: ABILIFY 7.5 mg/mL soluzzjoni għall-injezzjoni
English: In subgroup analyses the point estimate of the HR was 0.495 for subjects 13 to 14 years of age compared to 0.454 for subjects 15 to 17 years of age.
Maltese: 13 sa 14-il sena meta mqabbel ma' 0.454 fost dawk ta' 15 sa 17-il sena.
English: ABILIFY 5 mg tablets Indigo carmine aluminium lake (E 132)
Maltese: Indigo karminju aluminju aħmar skur (E 132)
English: ABILIFY 10 mg tablets
Maltese: ABILIFY 10 mg pilloli
English: Each vial contains 9.75 mg aripiprazole.
Maltese: Kull kunjett fih 9.75 mg ta' aripiprazole.
English: Tics associated with Tourette's disorder: the safety and efficacy of ABILIFY in children and adolescents 6 to 18 years of age have not yet been established.
Maltese: Tikks assoċjati mad-disturb ta' Tourette: is-sigurtà u l-effikaċja ta' ABILIFY fit-tfal u adolexxenti bejn 6 snin u 18-il sena ma ġewx determinati s'issa.
English: In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary endpoint was weight gain, significantly less patients had at least 7 % weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg) on oral aripiprazole (n = 18, or 13 % of evaluable patients), compared to oral olanzapine (n = 45, or 33 % of evaluable patients).
Maltese: Fi studju ta' 26 ġimgħa multi-nazzjonali double-blind fuq l-iskiżofrenja ikkontrollat bl-olanzapine li inkluda 314 pazjent adult u fejn l-end-point primarju kien iż-żieda fil-piż, inqas pazjenti kellhom millinqas żieda ta' 7 % fil-piż fuq il-linja bażi b'mod sinifikattiv (i.e. żieda ta' mill-inqas ta' 5.6 kg għall punt medjan tal-linja bażi tal-piż - 80.5 kg) fuq aripiprazole (n = 18, jew 13 % tal-pazjenti evalwabbli), mqabbla ma' olanzapine orali (n = 45, jew 33 % tal-pazjenti evalwabbli).
English: Other extrapyramidal symptoms
Maltese: Sintomi ekstrapiramidali oħra
English: Agitation in schizophrenia and Bipolar I Disorder with ABILIFY solution for injection In two short- term (24-hour) placebo-controlled trials involving 554 schizophrenic adult patients presenting with agitation and disturbed behaviours, ABILIFYsolution for injection was associated with statistically significant greater improvements in agitation/behavioural symptoms compared to placebo and was similar to haloperidol.
Maltese: Aġitazzjoni fi skiżofrenja u f'Disturb Bipolari I b'soluzzjoni ta' ABILIFY għall-injezzjoni F'żewġ provi fuq medda qasira (24 siegħa) ikkontollati minn plaċebo li fihom kienu involuti 554 pazjent adult skiżofreniku li ppreżentaw mġiba ta' aġitazzjoni u disturbata, soluzzjoni ta' ABILIFY għall-injezzjoni kienet assoċjata ma' titjib statistikament sinifikanti akbar fis-sintomi ta' aġitazzjoni u ta' mġiba mqabbla ma' plaċebo u kienu l-istess għal haloperidol.
English: Aripiprazole has minor to moderate influence on the ability to drive and use machines due to potential nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia (see section 4.8).
Maltese: Aripiprazole għandu effett żgħir sa effett moderat fuq il-ħila biex issuq u tħaddem magni minħabba l-possibbiltà ta' effetti fuq is-sistema nervuża u effetti viżwali, bħal sedazzjoni, ħedla, sinkope, vista mċajpra, diplopja (ara sezzjoni 4.8).
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall fructose, malassorbiment tal-glucose-galactose jew nuqqas ta' sucrase-isomaltase, m'għandhomx jieħdu dan il-prodott mediċinali.
English: However, the estimation of the HR for the younger (13 to 14 years) group was not precise, reflecting the smaller number of subjects in that group (aripiprazole, n = 29; placebo, n = 12), and the confidence interval for this estimation (ranging from 0.151 to 1.628) did not allow conclusions to be drawn on the presence of a treatment effect.
Maltese: (aripiprazole, n = 29; plaċebo, n = 12), u l-intervall ta' kunfidenza għal din l-istima (li tvarja minn 0.151 sa 1.628) ma ppermettietx li jsiru konklużjonijiet fuq l-preżenza tal-effett tat-trattament.
English: Patients treated with any antipsychotics, including aripiprazole, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control (see section 4.8).
Maltese: Pazjenti kkurati b'antipsikotiċi, li jinkludu aripiprazole, għandhom ikunu osservati għal sinjali u sintomi ta' ipergliċemija (bħal polydipsia, polyuria, polyphagia u debbulizza) u pazjenti bid-dijabete mellitus jew b'fatturi ta' riskju għal dijabete mellitus għandhom ikunu mmonitorjati regolarment għal aggravar fil-kontroll tal-glucose (ara sezzjoni 4.8).
English: ABILIFY 15 mg tablets are round and yellow, marked with ‘A-009' and ‘15' on one side.
Maltese: ABILIFY 15 mg pilloli huma tondi u ta' kulur isfar bil-marka ‘A-009' u ‘15' fuq naħa waħda.
English: Population pharmacokinetic evaluation of oral aripiprazole has revealed no evidence of clinically relevant effects from smoking on the pharmacokinetics of aripiprazole.
Maltese: Evalwazzjoni farmakokinetika tal-popolazzjoni ta' aripiprazole orali ma rrivelat l-ebda prova ta' effetti klinikament rilevanti minn tipjip fuq il-farmakokinetika ta' aripiprazole.
English: Outer carton:
Maltese: Kartuna ta' barra:
English: Schizophrenia: the recommended starting dose for ABILIFY is 10 mg/day or 15 mg/day (i.e. 10 mL or 15 mL solution/day) with a maintenance dose of 15 mg/day administered on a once-a-day schedule without regard to meals.
Maltese: Skiżofrenja: id-doża tal-bidu rakkomandata għal ABILIFY hija ta' 10 mg/jum jew 15 mg/jum (i.e. 10 mL jew 15 mL soluzzjoni/kuljum) b'doża ta' manteniment ta' 15 mg/jum mogħtija fuq skeda ta' waħda kull jum mingħajr attenzjoni lejn l-ikliet.
English: Red iron oxide (E 172)
Maltese: Iron oxide aħmar (E 172)
English: 2 mg aspartame (E 951) and 0.075 mg lactose per orodispersible tablet
Maltese: 2 mg aspartame (E 951) u 0.075 mg lactose għal kull pillola li tinħall fil-ħalq
English: The most common treatment-emergent adverse events among patients receiving 30 mg were extrapyramidal disorder (28.3 %), somnolence (27.3 %), headache (23.2 %), and nausea (14.1 %).
Maltese: L-aktar każijiet avversi komuni li joħorġu mit-trattament fost pazjenti li qed jirċievu 30 mg kienu disturb ekstrapiramidali (28.3 %), ħedla (27.3 %), uġigħ ta' ras (23.2 %), u dardir (14.1 %).
English: Population pharmacokinetic evaluation has revealed no evidence of clinically significant effects from smoking on the pharmacokinetics of aripiprazole.
Maltese: Studju farmakokinetiku tal-popolazzjoni ma wera l-ebda evidenza ta' effetti klinikament sinifikanti minn tipjip fuq il-farmakokinetika ta' aripiprazole.
English: Each carton contains 1 bottle and both a calibrated polypropylene measuring cup with a graduation interval of 2.5 mL and a calibrated polypropylene low-density polyethylene dropping pipette with a graduation interval of 0.5 mL.
Maltese: gradwazzjoni ta' 2.5 mL u pipetta għat-tqattir ikkalibrat tal-polypropylene maghmul minn polyethylene b'densita' baxxa b'intervall ta' gradwazzjoni 0.5 mL.
English: How to store ABILIFY
Maltese: Tużax ABILIFY
English: ABILIFY 30 mg tablets aripiprazole
Maltese: ABILIFY 30 mg pilloli aripiprazole
English: ABILIFY 5 mg tablets
Maltese: ABILIFY 5 mg pilloli
English: 6 mg aspartame (E 951) and 0.225 mg lactose per orodispersible tablet
Maltese: 6 mg aspartame (E 951) u 0.225 mg lactose għal kull pillola li tinħall fil-ħalq
English: • trembling,
Maltese: • itterter,
English: ABILIFY 10 mg tablets:
Maltese: ABILIFY 10 mg pilloli:
English: Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus allergic, or urticaria)
Maltese: Reazzjoni allerġika (eż. reazzjoni anafilattika, anġjoedima li tinkludi lsien minfuħ, edima tal-ilsien, edima tal-wiċċ, ħakk allerġiku, jew urtikarja)
English: • reports of abnormal liver tests values,
Maltese: • rapporti ta' valuri anormali ta' testijiet tal-fwied,
English: Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1, 56 × 1, 98 × 1 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji ta' l-aluminju perforati għal unità ta' doża f'kartun ta' 14 × 1, 28 × 1, 49 × 1, 56 × 1,
English: The recommended dose for adults is 15 mL solution (corresponding to 15 mg aripiprazole) once a day.
Maltese: Id-doża rakkomandata għall-adulti hija 15 mL soluzzjoni (li tikkorrespondi għal 15 mg aripiprazole) darba kuljum.
English: In contrast the 95 % confidence interval for the HR in the older subgroup (aripiprazole, n = 69; placebo, n = 36) was 0.242 to 0.879 and hence a treatment effect could be concluded in the older patients.
Maltese: n = 69; plaċebo, n = 36) kien 0.242 sa 0.879 u għalhekk l-effett ta' trattament seta jiġi konkluż f'pazjenti akbar fl-età.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Maltese: Kien hemm rapporti ta' aġitazzjoni, ipertonja, ipotonja, rogħda,ħedla, distress respiratorju, jew disturb fit-tmigħ.
English: Aspiration pneumonia Laryngospasm Oropharyngeal spasm
Maltese: Laringospażmu Spażmu orofarinġeali
English: Urinary incontinence Urinary retention
Maltese: Inkontinenza tal-awrina
English: ABILIFY 1 mg/mL oral solution is a clear, colourless to light yellow liquid supplied in bottles with polypropylene child-resistant closure containing 50 mL, 150 mL or 480 mL per bottle.
Maltese: ABILIFY 1 mg/mL soluzzjoni orali hija likwidu ċar, bla kulur għal likwidu safrani ċar fornut fi fliexken b'tapp tal-polypropylene li t-tfal isibu diffiċli biex jiftħu b'50 mL, 150 mL jew 480 mL kull flixkun.
English: Schizophrenia: in a long-term 52-week controlled trial, aripiprazole-treated patients had an overalllower incidence (25.8 %) of EPS including Parkinsonism, akathisia, dystonia and dyskinesia compared with those treated with haloperidol (57.3 %).
Maltese: Skiżofrenja: waqt studju ikkontrollat fit-tul ta' 52 ġimgħa, pazjenti kkurati b'aripiprazole kellhom tnaqqis totali (25.8 %) ta' EPS li jinkludu Parkinsoniżmu, akatiżja u diskineżja, meta mqabbla ma'
English: In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult patients, presenting with positive or negative symptoms, oral aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Maltese: Fi tliet provi kliniċi fuq medda qasira (4 sa 6 ġimgħat) ikkontrollati minn plaċebo li fihom kienu involuti 1,228 pazjent adulti skiżofreniku li wrew sintomi pożittivi jew negattivi, aripiprazole orali kien assoċjat ma' titjib statistikament sinifikanti akbar fis-sintomi psikotiċi meta mqabbla malplaċebo.
English: Simultaneous administration of injectable antipsychotics and parenteral benzodiazepine may be associated with excessive sedation and cardiorespiratory depression.
Maltese: Amministrazzjoni simultanja ta' antipsikotiċi li jistgħu jkunu injettati u parenteral benzodiazepine jistgħu jkunu assoċjati ma' sedazzjoni eċċessiva u dipressjoni kardjorespiratorja.
English: In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13 to 17 years), presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Maltese: Fi prova klinika li damet 6 ġimgħat, ikkontrollata bil-plaċebo, li kienet tinvolvi 302 pazjenti adolexxenti skiżofreniċi (minn 13 sa 17-il sena) li kellhom sintomi pożittivi jew negattivi, aripiprazole kien assoċjat ma' titjib li kien statistikament ħafna akbar f'sintomi psikotiċi meta mqabbel malplaċebo.
English: • cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
Maltese: • mard kardjovaskulari (mard tal-qalb u taċ-ċirkolazzjoni), storja ta' mard kardjovaskulari fil-familja, puplesija jew attakk ħafif ta' puplesija, pressjoni mhux normali
English: ABILIFY 10 mg tablets aripiprazole
Maltese: ABILIFY 10 mg pilloli aripiprazole
English: Round and pink, engraved with "A-011" and "30" on one side.
Maltese: Tonda u roża, imnaqqxa b'“A-011” u “30” fuq naħa waħda.
English: • thoughts of suicide, suicide attempt and suicide,
Maltese: • żieda fil-piż, • tentattiv ta' suwiċidju, suwiċidju,
English: Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10).
Maltese: Ngħas/sedazzjoni u disturb ekstrapiramidali kienu rrappurtati b'mod komuni ħafna (≥ 1/10), u ħalq xott, żieda fl-aptit, u pressjoni tad-demm baxxa meta wieħed ikun bilwieqfa kienu rrappurtati b'mod komuni (≥ 1/100, < 1/10).
English: EU/1/04/276/016 (30 mg, 14 × 1 tablets) EU/1/04/276/017 (30 mg, 28 × 1 tablets) EU/1/04/276/018 (30 mg, 49 × 1 tablets) EU/1/04/276/019 (30 mg, 56 × 1 tablets) EU/1/04/276/020 (30 mg, 98 × 1 tablets)
Maltese: EU/1/04/276/016 (30 mg, 14 × 1 pilloli) EU/1/04/276/017 (30 mg, 28 × 1 pilloli) EU/1/04/276/018 (30 mg, 49 × 1 pilloli) EU/1/04/276/019 (30 mg, 56 × 1 pilloli) EU/1/04/276/020 (30 mg, 98 × 1 pilloli)
English: Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater than 1 in 100 patients).
Maltese: Adolexxenti li kellhom 13-il sena jew aktar, kellhom effetti sekondarji li kienu simili fil-frekwenza u fit-tip għal dawk fl-adulti, ħlief li l-irqad, kontrazzjonijiet jew movimenti bl-iskossi li ma setgħux jiġu kkontrollati, ma kellhomx kwiet f'ġisimhom u għeja kienu komuni ħafna (aktar minn 1 f'kull 10 pazjenti) u wġigħ fil-parti ta' fuq tal-addome, ħalq xott, żieda fir-rata ta' taħbit tal-qalb, żieda fil piż, żieda fl-aptit, kontrazzjonijiet tal-muskoli, movimenti mhux ikkontrollati tad-dirgħajn u tas saqajn, u sensazzjoni ta' sturdament, speċjalment meta tqum bilwieqfa meta tkun mimdud/a jew bilqiegħda, kienu komuni (aktar minn 1 f'kull 100 pazjent).
English: Administration of ABILIFY solution for injection was well tolerated and produced no direct target organ toxicity in rats or monkeys after repeated dosing at systemic exposures (AUC) that were 15 and 5 times, respectively, human exposure at the maximum recommended human dose of 30 mg intramuscular.
Maltese: L-għoti ta' soluzzjoni aripiprazole għall-injezzjoni kienet tollerata tajjeb u ma pproduċiet l-ebda vvelenar dirett direttament lejn xi organu f' firien jew xadini wara li ngħataw dożi ripetuti b'espożizzjoni sistematika (AUC) li kienu 15 u 5 darbiet, rispettivament, l-espożizzjoni umana tad doża umana massima rakkomaandata ta' 30 mg fil-muskolu.
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: Klinikament NMS jista' juri deni għoli, muskoli jibbiesu, stat mentali mibdul u evidenza ta' instabilità tas-sistema autonomika
English: ABILIFY 5 mg tablets:
Maltese: ABILIFY 5 mg pilloli:
English: In the pooled adolescent schizophrenia population (13 to 17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 29.5 % and 48.3 %, respectively.
Maltese: Fil-popolazzjoni miġbura ta' adolexxenti (13 sa 17-il sena) li jbatu bl-iskiżofrenja li kellhom espożizzjoni sa sentejn, l-inċidenza ta' livelli baxxi ta' prolactin fis-serum fin-nisa (< 3 ng/mL) u fl irġiel (< 2 ng/mL) kienet ta' 29.5 % u ta' 48.3 % respettivament.
English: Leukopenia Neutropenia Thrombocytopenia
Maltese: Lewkopenija Newtropenija
English: ABILIFY 15 mg tablets:
Maltese: ABILIFY 15 mg pilloli:
English: Yellow iron oxide (E 172)
Maltese: iron oxide isfar (E 172).
English: ABILIFY solution for injection is indicated for the rapid control of agitation and disturbed behaviours in adult patients with schizophrenia or with manic episodes in Bipolar I Disorder, when oral therapy is not appropriate.
Maltese: ABILIFY soluzzjoni għall-injezzjoni hu indikat għall-kontroll rapidu ta' aġitazzjoni u mġiba disturbata f'pazjenti adulti bi skiżofrenja jew b'episodji manijaċi f'Disturb Bipolari I, meta terapija orali ma tkunx adattata.
English: Aripiprazole/metabolites are excreted in human milk.
Maltese: Aripiprazole/metaboliti huma eliminati fil-ћalib tas-sider tal-bniedem.
English: Overall, 1.3 % of aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of placebo-treated patients in these trials.
Maltese: Bħala total, 1.3 % ta' pazjenti kkurati b'aripirazole irrapurtaw reazzjonijiet avversi ċerebrovaskulari mqabbla ma'
English: ABILIFY 30 mg orodispersible tablets are round and pink, marked with ‘"A" over "643"' on one side and ‘30' on the other.
Maltese: ABILIFY 30 mg pilloli li jinħallu fil-ħalq huma tondi u ta' kulur roża bil-marka ‘"A" fuq "643"' fuq naħa u ‘30' fuq in-naħa l-oħra.
English: Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax and AUC for aripiprazole were 68 % and 73 % lower, respectively, compared to when aripiprazole (30 mg) was administered alone.
Maltese: Wara l-għoti fl-istess waqt ta'carbamazepine, induttur qawwi ta' CYP3A4, u aripiprazole orali lil pazjenti bi skiżofrenja jew disturb skiżoaffettiv, il-medji ġeometriċi tas-Cmax u l-AUC ta' aripriprazole kienu ta' 68 % u 73 % inqas, rispettivament, meta mqabbla ma' meta aripiprazole (30 mg) ġie mogħti waħdu.
English: In a clinical trial in healthy subjects, a strong inhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63 % and 37 %, respectively.
Maltese: (ketoconazole) żied l-AUC u s-Cmax ta' aripiprazole b'63% u 37 % rispettivament.
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis)
Maltese: Tromboemboliżmu fil-vini (li jinkludi emboliżmu fil-pulmuni u trombożi fil-vini tal-fond)
English: Each mL contains 7.5 mg of aripiprazole.
Maltese: Kull mL fih 7.5 mg ta' aripiprazole.
English: • hiccups,
Maltese: • puplesija,
English: All ADRs are listed by system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to
Maltese: arritmija, u lewkopenija kienu rrapportati b'mod komuni (≥ 1/100, < 1/10).
English: ABILIFY 15 mg tablets
Maltese: ABILIFY 15 mg pilloli
English: In one short-term (24-hour) placebo-controlled trial involving 291 patients with bipolar disorder presenting with agitation and disturbed behaviours, ABILIFY solution for injection was associated with statistically significant greater improvements in agitation/behavioural symptoms compared to placebo and was similar to the reference arm lorazepam.
Maltese: Fi prova qasira (24 siegħa) kkontrollata bi plaċebo li involviet 291 pazjent b'disturb bipolari preżenti b'aġitazzjoni u b'imġiba disturbata, soluzzjoni ta' ABILIFY għall-injezzjoni ġiet assoċjata ma' titjib statistikament ferm ikbar f'sintomi ta' aġitazzjoni/imġiba meta mqabbla ma' plaċebo u kien simili għall-fergħa ta' referenza ta' lorazepam.
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0 %),
Maltese: Il-frekwenza u t-tip ta' reazzjonijiet avversi f'adolexxenti b'Disturb Bipolari I kienu simili għal dawk fl-adulti barra r-reazzjonijiet li ġejjin: komuni ħafna (≥ 1/10) ngħas (23.0 %), disturb ekstrapiramidali
English: ABILIFY 15 mg orodispersible tablets are round and yellow, marked with ‘"A" over "641"' on one side and ‘15' on the other.
Maltese: ABILIFY 15 mg pilloli li jinħallu fil-ħalq huma tondi u ta' kulur isfar bil-marka ‘"A" fuq "641"' fuq naħa u ‘15' fuq in-naħa l-oħra