FrancophonIA/ELRC3.0 huggingface dataset:
English: Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablets Blister packs in cartons: 10, 14, 16, 28, 30, 35, 56, 70 tablets Blister packs (unit dose) in cartons: 14 x 1, 28 x 1, 49 x 1, 56 x 1, 98 x 1 tablet Bottle packs in cartons: 100 tablets
Maltese: Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg pilloli Pakketti bil-folji f'kaxxi tal-kartun: 10, 14, 16, 28, 30, 35, 56, 70 pillola Pakketti bil-folji (doża tal-unità) f'kaxxi tal-kartun: 14 x 1, 28 x 1, 49 x 1, 56 x 1, 98 x 1 pillola Pakketti bil-fliexken f'kaxxi tal-kartun: 100 pillola
English: Consequently, the frequency of these adverse events is qualified as "not known"
Maltese: Għaldaqstant, il-frekwenza ta' dawn il-każijiet avversi hi kkwalifikata bħala “mhux magħruf”.
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Maltese: Każijiet ta' tromboemboliżmu venuż (VTE) kienu rrappurtati bi prodotti mediċinali antipsikotiċi.
English: The following adverse reactions had a possible dose response relationship; extrapyramidal disorder (incidences were 10 mg, 9.1%, 30 mg, 28.8%, placebo, 1.7%,); and akathisia (incidences were 10 mg, 12.1%, 30 mg, 20.3%, placebo, 1.7%).
Maltese: Dawn ir- reazjonijiet avversi kellhom relazzjoni possibbli mar-rispons tad-doża; disturb ekstrapiramidali (l-inċidenzi kienu 10 mg, 9.1 %, 30 mg, 28.8 %, plaċebo, 1.7 %); u akatisija (linċidenzi kienu 10 mg, 12.1 %, 30 mg, 20.3 %, plaċebo, 1.7 %).
English: In clinical studies, 10-30 mg/day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan).
Maltese: Fi studji kliniċi, dożi ta' aripiprazole ta' 10-30 mg/jum ma kellhom l-ebda effett sinifikanti fuq issubstrati ta' CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), u CYP3A4
English: LIST OF EXCIPIENTS Also contains: lactose monohydrate.
Maltese: TA' EĊĊIPJENTI Fih ukoll: lactose monohydrate.
English: In three placebo-controlled trials (n=938; mean age: 82.4 years; range: 56-99 years) of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, patients treated with aripiprazole were at increased risk of death compared to placebo.
Maltese: Fi tliet provi kkontrollati minn plaċebo (n= 938; età medja: 82.4 snin; medda: 56-99 sena) ta' aripiprazole f'pazjenti anzjani bi psikosi assoċjata mal-marda Alzheimer, pazjenti kkurati b'aripiprazole kellhom riskju ogħla ta' mewt meta mqabbla ma' dawk fuq plaċebo.
English: Aspiration pneumonia Laryngospasm Oropharyngeal spasm
Maltese: Pulmonite minn aspirazzjoni Laringospażmu Spażmu orofarinġeali
English: This difference was not statistically significant.
Maltese: Din id-differenza ma kinitx statistikament sinifkanti.
English: In the same trials, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78-88 years).
Maltese: Fl-istess provi, kienu rrapportati reazzjonijiet avversi ċerebrovaskulari (eż. puplesija, attakk iskemiku temporanju), inklużi uħud fatali, f'pazjenti (età medja: 84 sena; medda: 78-88 sena).
English: The AUC and Cmax of dehydro-aripiprazole increased by 77% and 43%, respectively.
Maltese: L-AUC u Cmax ta' dehydro-aripiprazole żdiedu b'77 % u 43 % rispettivament.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 August 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Awwissu 2015
English: Four mood stabilizer subgroups were assessed in the randomised phase: aripiprazole + lithium; aripiprazole + valproate; placebo + lithium; placebo + valproate.
Maltese: Erba' sottogruppi ta' stabbilizzaturi tal-burdata kienu assessjati fil-fażi li fiha l-pazjenti ntgħażlu b'mod każwali: aripiprazole + lithium; aripiprazole + valproate, plaċebo + lithium; plaċebo + valproate.
English: Elevations of CPK (Creatine Phosphokinase), generally transient and asymptomatic, were observed in 3.5% of aripiprazole treated patients as compared to 2.0% of patients who received placebo.
Maltese: Elevazzjonijiet ta' CPK (Creatine Phosphokinase), ġeneralment temporanji u asintomatiċi, kienu osservati f'3.5 % tal-pazjenti ikkurati b'aripiprazole meta mqabbla ma' 2.0 % talpazjenti li rċevew plaċebo.
English: Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5-HT1a and 5-HT2a receptors and moderate affinity for dopamine D4, serotonin 5-HT2c and 5-HT7, alpha-1 adrenergic and histamine H1 receptors.
Maltese: Aripiprazole wera affinità ta' rabta qawwija in vitro għar-riċetturi tad-dopamina D2 u D3, tas-serotonina 5HT1a u 5HT21, u b'mod inqas qawwi mar-riċetturi tad-dopamina D4, tas-serotonina 5HT2c u 5HT7, α1-adrenerġiki u H1 istamina.
English: The Kaplan-Meier rates for recurrence to any mood episode for the adjunctive treatment arm were 16% in aripiprazole + lithium and 18% in aripiprazole + valproate compared to 45% in placebo + lithium and 19% in placebo + valproate.
Maltese: Irrati ta' Kaplan-Meier għal rikorrenza ta' kwalunkwe episodju ta' burdata fil-fergħa tal-kura aġġuntiva kienu 16 % f'aripiprazole + lithium u 18 % f'aripiprazole + valproate meta mqabbla ma' 45 % fi plaċebo + lithium u 19 % fi plaċebo + valproate.
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%), extrapyramidal disorder (18.4%), akathisia (16.0%), and fatigue (11.8%); and commonly (≥ 1/100, < 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia.
Maltese: Episodji manijaċi f'Disturb Bipolari I f'adolexxenti li għandhom 13-il sena u aktar Il-frekwenza u t-tip ta' reazjonijiet 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 (18.4 %), akatisija (16 %), u għeja (11.8 %); u komuni (≥ 1/100, < 1/10) uġigħ fil-parti ta' fuq taladdome, żieda fir-rata ta' taħbit tal-qalb, żieda fil-piż, żieda fl-aptit, kontrazzjonijiet tal-muskoli, u diskinesija.
English: Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reductions should therefore be applied.
Maltese: Inibituri potenti oħrajn ta' CYP2D6, bħal fluoxetine u paroxetine jista' jkun li jkollhom effetti simili u għalhekk għandu jiġi applikat tnaqqis simili tad-doża.
English: In a 52-week, placebo-controlled trial, in patients with a current manic or mixed episode of Bipolar I Disorder who achieved sustained remission (Y-MRS and MADRS total scores ≤ 12) on aripiprazole (10 mg/day to 30 mg/day) adjunctive to lithium or valproate for 12 consecutive weeks, adjunctive aripiprazole demonstrated superiority over placebo with a 46% decreased risk (hazard ratio of 0.54) in preventing bipolar recurrence and a 65% decreased risk (hazard ratio of 0.35) in preventing recurrence into mania over adjunctive placebo but failed to demonstrate superiority over placebo in preventing recurrence into depression.
Maltese: Fi prova li damet sejra għal 52 ġimgħa, bil-plaċebo bħala kontroll, f'pazjenti li attwalment kellhom episodju manijaku jew episodju mħawwad ta' Disturb Bipolari I li kisbu remissjoni sostnuta (punteġġi totali ta' ≤ 12 għal Y-MRS u MADRS) b'aripiprazole (10 mg/kuljum sa 30 mg/kuljum) bħala mediċina aġġuntiva għal litju jew valproate għal 12-il ġimgħa konsekuttiva, l-għoti ta' aripiprazole bħala mediċina aġġuntiva wera superjorità fuq il-plaċebo b'riskju mnaqqas ta' 46 % (proporzjon ta' periklu ta' 0.54) fil-prevenzjoni ta' rikorrenza bipolari u riskju mnaqqas ta' 65 % (proporzjon ta' periklu ta' 0.35) fil-prevenzjoni ta' rikorrenza f'manija meta mqabbel mal-plaċebo li ngħata bħala mediċina aġġuntiva imma naqas li juri superjorità fuq il-plaċebo fil-prevenzjoni ta' rikorrenza f'dipressjoni.
English: It has been proposed that aripiprazole's efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1a receptors and antagonism of serotonin 5-HT2a receptors.
Maltese: Ġie propost li l-effikaċja ta' aripiprazole fuq l-iskizofrenja u Disturb Bipolari I hija medjatur bejn taħlita ta' agoniżmu parzjali tar-riċetturi dopamina D2 u serotonina 5HT1a, u antagoniżmu tar- riċetturi serotonina 5HT2.
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, HDL and LDL.
Maltese: F'analiżi miġbura fuq parametri tal-lipidi minn provi kliniċi kkontrollati bi plaċebo f'persuni adulti, ma ntweriex li aripiprazole jikkaġuna tibdil klinikament relevanti fil-livelli ta' kolesterol totali, trigliċeridi, HDL u LDL.
English: Oculogyric crisis: From post-marketing sources, there were 20 reports of oculogyric crisis during the interval (11 serious) and 244 reports cumulatively (92 serious).
Maltese: Minn sorsi ta' wara t-tqegħid fis-suq, kien hemm 20 rapport ta' kriżi tad-dawrien tal-ballun tal-għajn matul l-intervall (11 serji) u 244 rapport b'mod kumulattiv (92 serji).
English: Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/kg, indicating extensive extravascular distribution.
Maltese: Aripiprazole jiġi distribwit b'mod estensiv fil-ġisem, bil-volum medju ta' distribuzzjoni apparenti ta' 4.9 l/kg, li juri distribuzzjoni estensiva fis-sistema ekstravaskulari.
English: In the placebo-controlled trials, the mean weight gain was 0.4 kg for placebo and 1.6 kg for aripiprazole.
Maltese: Fil-provi kkontrollati bi plaċebo, iż-żieda medja fil-piż kienet ta' 0.4 kg għall-plaċebo u 1.6 kg għal aripiprazole.
English: Actual scores in rating scales used as secondary endpoints, including PANSS and the Montgomery-Asberg Depression Rating Scale showed a significant improvement over haloperidol.
Maltese: Il-punteġġi attwali fl-iskali talklassifika użati bħala endpoints sekondarji, li jinkludu PANSS u il-Montgomery-Asberg Depression Rating Scale urew titjib sinifikanti fuq haloperidol.
English: Aripiprazole Sandoz 5 mg tablets Aripiprazole Sandoz 10 mg tablets Aripiprazole Sandoz 15 mg tablets Aripiprazole Sandoz 20 mg tablets Aripiprazole Sandoz 30 mg tablets
Maltese: Aripiprazole Sandoz 5 mg pilloli Aripiprazole Sandoz 10 mg pilloli Aripiprazole Sandoz 15 mg pilloli Aripiprazole Sandoz 20 mg pilloli Aripiprazole Sandoz 30 mg pilloli aripiprazole
English: In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain in adults (see section 5.1).
Maltese: Fi provi kliniċi aripiprazole ma deherx li wassal għal żieda fil-piż klinikament relevanti f'adulti (ara sezzjoni 5.1).
English: Aripiprazole is metabolised by multiple pathways involving the CYP2D6 and CYP3A4 enzymes but not CYP1A enzymes.
Maltese: Aripiprazole jiġi metabolizzat b'diversi sistemi li jirrikjedu l-enzimi CYP2D6 u CYP3A4 iżda mhux l-enzimi CYP1A.
English: Schizophrenia: in a long term 52-week controlled trial, aripiprazole-treated patients had an overall-lower incidence (25.8%) of EPS including Parkinsonism, akathisia, dystonia and dyskinesia compared with those treated with haloperidol (57.3%).
Maltese: Skizofrenija: 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' dawk ikkurati b'haloperidol (57.3 %).
English: Aluminium//Aluminium unit dose blisters packed in cartons containing 14 x 1, 28 x 1, 49 x 1, 56 x 1 or 98 x 1 tablet.
Maltese: Folji tal-Aluminju//Aluminju bid-doża tal-unità ppakkjati f'kartun li jkun fih 14 x 1, 28 x 1, 49 x 1, 56 x 1 jew 98 x 1 pillola.
English: Aripiprazole doses ranging from 0.5 to 30 mg administered once a day to healthy subjects for 2 weeks produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor ligand, to the caudate and putamen detected by positron emission tomography.
Maltese: Dożi ta' aripiprazole li jvarjaw minn 0.5 sa 30 mg mogħtija darba kuljum għal ġimagħtejn lil nies b'saħħithom ipproduċew tnaqqis ta' dipendanza fuq id-droga fl-irbit ta' 11C-raclopride, riċettur li jgħaqqad D2/D3, caudate u l-putamen osservati bit-tomografija bl-emissjoni positronika.
English: Overall, 1.3% of aripiprazoletreated 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'aripiprazole irrapurtaw reazzjonijiet avversi ċerebrovaskulari meta mqabbla ma' 0.6 % ta' pazjenti kkurati bil-plaċebo f'dawn il-provi.
English: Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).
Maltese: Aripiprazole Sandoz hu indikat għall-kura ta' episodji manijaċi minn moderati sa severi f'Disturb Bipolari I u għall-prevenzjoni ta' episodju manijaku ġdid f'adulti li esperjenzaw episodji predominantament manijaċi u li l-episodji manijaċi tagħhom irrispondew għall-kura ta' aripiprazole (ara sezzjoni 5.1).
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, muskoli jibbiesu, stat mentali mibdul u evidenza ta' instabilità tas-sistema autonomika (polz mhux regolari jew pressjoni mhux normali, qalb tħabbat iktar mis-soltu, għaraq, u qalb ma tħabbatx regolari).
English: Population pharmacokinetic evaluation showed no evidence of race-related differences on the pharmacokinetics of aripiprazole.
Maltese: Evalwazzjoni farmakokinetika tal-popolazzjoni ma uriet l-ebda evidenza ta' differenza marbuta ma' razza fuq il-farmakokinetika ta' aripiprazole.
English: An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of hydroxy metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 to 125 mg/kg/day (1 to 3 times the mean steady-state AUC at the maximum recommended clinical dose or 16 to 81 times the maximum recommended human dose based on mg/m2).
Maltese: Kien hemm ukoll każijiet ta' ġebla minħabba preċipitazzjoni tal-konjugi sulfatizzati tal-metaboliti idroġenizzati ta' aripiprazole fil-bile tax-xadini wara li ħadu dożi ripetuti ta' 25 sa 125 mg/kg/jum mill-ħalq (1 sa 3 darbiet iktar mill-medja tal-AUC fi stat stabbli fid-doża massima rakkomandata filbnedmin jew 16 sa 81 darba iktar mid-doża massima rakkomandata fil-bniedem imkejla bħala mg/m2).
English: In a 26-week, placebo-controlled trial in adult stabilised patients with chronic schizophrenia, aripiprazole had significantly greater reduction in relapse rate, 34% in aripiprazole group and 57% in placebo.
Maltese: Fi provi ta' 26 ġimgħa kkontrollati bi plaċebo f'pazjenti adulti stabbilizzati, bi skizofrenja kronika, aripiprazole orali kellu tnaqqis ferm akbar fir-rata ta' pazjenti li rkadew, 34 % fil-grupp ta' aripiprazole orali u 57 % fil-plaċebo.
English: Aripiprazole Sandoz contains the active substance aripiprazole and belong to a group of medicines called antipsychotics.
Maltese: Aripiprazole Sandoz fihom is-sustanza attiva aripiprazole u jappartjenu għal grupp ta' mediċini msejħa antipsikotiċi.
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: Inibituri qawwija oħrajn ta' CYP3A4, bħal itraconazole u inibituri tal-protease tal-HIV, jistgħu jkunu mistennija li jkollhom effetti simili u għalhekk għandu jiġi applikat tnaqqis simili taddoża (ara sezzjoni 4.2).
English: The potentially medically important signs and symptoms observed included lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea.
Maltese: Is-sinjali u sintomi osservati li possibbilment huma medikament importanti jinkludu letarġija, żieda fil-pressjoni tad-demm, ħedla ta' rqad, tatikardija, nawseja, rimettar u dijarea.
English: These included: dose-dependent adrenocortical toxicity (lipofuscin pigment accumulation and/or parenchymal cell loss) in rats after 104 weeks at 20 to 60 mg/kg/day (3 to 10 times the mean steady-state AUC at the maximum recommended human dose) and increased adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas in female rats at 60 mg/kg/day (10 times the mean steady-state AUC at the maximum recommended human dose).
Maltese: Dawn jinkludu: tossiċità adreno-kortikali li tiddependi fuq id-doża (ġbir ta' pigment lipofuscin u/jew telf ta' ċelloli parenkimali) f'firien wara 104 ġimgħat fuq doża ta' 20 sa 60 mg/kg/jum (3 sa 10 darbiet aqwa mill-medja fi stat stabbli tal-AUC flakbar doża rakkomandata għall-bnedmin) u żieda ta' tumuri adrenokortikali flimkien ma' adenomi taċ-ċelloli adrenokortikali/karċinomi fi ġrieden tas-sess femminili b'doża ta' 60 mg/kg/jum (10 darbiet ikbar mill-medja tal-AUC fi stat stabbli fid-doża massima rakkomandata fil-bnedmin).
English: Manic episodes in Bipolar I Disorder: in a 12-week controlled trial, the incidence of EPS was 23.5% for aripiprazole-treated patients and 53.3% for haloperidol-treated patients.
Maltese: Episodji manijaċi f'Disturb Bipolari I: fi prova kkontrollata ta' 12-il ġimgħa, l-inċidenza ta' EPS kienet ta' 23.5 % għal pazjenti kkurati b'aripiprazole u 53.3 % għal pazjenti kkurati b'haloperidol.
English: In a 60- to 89-week, randomised, double-blind, placebo-controlled trial in adolescent subjects (n = 146; ages 13-17 years) with schizophrenia, there was a statistically significant difference in the rate of relapse of psychotic symptoms between the aripiprazole (19.39%) and placebo (37.50%) groups.
Maltese: Fi prova każwali, double-blind ta' minn 60 ġimgħa sa 89 ġimgħa, bi plaċebo bħala kontroll f'individwi adolexxenti (n = 146; etajiet ta' 13-17-il sena) bi skiżofrenija, kien hemm differenza statistikament sinifikanti fir-rata ta' rkadar ta' sintomi psikotiċi bejn il-gruppi ta' aripiprazole (19.
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 rriżultaw mill-kura fost pazjenti li rċevew 30 mg kienu disturb ekstrapiramidali (28.3 %), ħedla (27.3 %), uġigħ ta' ras (23.2 %), u dardir (14.1 %).
English: Mean changes in body weight in adolescents with Bipolar I Disorder at 12 and 30 weeks for aripiprazole were 2.4 kg and 5.8 kg, and for placebo 0.2 kg and 2.3 kg, respectively.
Maltese: Tibdil medju fil-piż tal-ġisem f'adolexxenti b'Disturb Bipolari I wara 12-il ġimgħa, u 30 ġimgħa għal aripiprazole kien 2.4 kg u 5.8 kg u għal plaċebo 0.2 kg u 2.3 kg, rispettivament.
English: In the pooled trials, the incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) in aripiprazole-treated patients was 27/46 (58.7%) and 258/298 (86.6%), respectively.
Maltese: Fil-provi miġbura, linċidenza tal-livelli baxxi ta' prolactin fis-serum fin-nisa (< 3 ng/mL) u fl-irġiel (< 2 ng/mL) f'pazjenti kkurati b'aripiprazole kienet 27/46 (58.7 %) u 258/298 (86.6 %), rispettivament.
English: Pancreatitis Dysphagia Diarrhoea
Maltese: Pankreatite Disfaġja
English: Packsizes:
Maltese: PC:
English: Patients were 7 - 17 years of age and presented an average score of 30 on Total Tic Score on the Yale Global Tic Severity Scale (TTS-YGTSS) at baseline.
Maltese: Il-pazjenti kellhom bejn 7 snin - 17-il sena u kienu ppreżentati b'punteġġ medju ta' 30 fit-Total Tic Score fil-Global Tic Severity Scale (TTS-YGTSS) fil-linja bażi.
English: Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: • rapid heartbeat, agitation/aggressiveness, problems with speech.
Maltese: • taħbit mgħaġġel tal qalb, aġitazzjoni/aggressività, problemi fit-taħdit.
English: The mean elimination half-lives for aripiprazole are approximately 75 hours in extensive metabolisers of CYP2D6 and approximately 146 hours in poor metabolisers of CYP2D6.
Maltese: Il-medja tal-half-lives ta' eliminazzjoni għal aripiprazole hija madwar 75 siegħa f'metabolituri estensivi ta' CYP2D6 u madwar 146 siegħa f'metabolituri dgħajfin ta' CYP2D6.
English: In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated patients and 15.1% for olanzapinetreated patients.
Maltese: Fi studju ieħor ikkontrollat fit-tul ta' 26 ġimgħa, l-inċidenza ta' EPS kienet 14.8 % f'pazjenti kkurati b'aripiprazole u 15.1 % għall-pazjenti kkurati b'olanzapine.
English: Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablets High density polyethylene (HDPE) tablet container (bottle) containing a silica gel desiccant and a polyester coil.
Maltese: Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg pilloli Kontenitur tal-pilloli (flixkun) magħmul minn polyethylene ta' densità għolja (HDPE) li jkun fih dessikant u kojl tal-polyester.
English: In schizophrenia patients the incidence of akathisia was 6.2% with aripiprazole and 3.0% with placebo.
Maltese: F'pazjenti bi skizofrenija, l-inċidenza ta' akatisja kienet ta' 6.2 % b'aripiprazole u 3.0 % bi plaċebo.
English: In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107%, while Cmax was unchanged.
Maltese: Fi studju kliniku f'pazjenti b'saħħithom, inibitur qawwi tas-CYP2D6 (quinidine) żied l-AUC ta' aripiprazole b'107 % waqt li Cmax ma tbiddilx.
English: Irritability associated with autistic disorder in paediatric patients (see section 4.2) Aripiprazole was studied in patients aged 6 to 17 years in two 8-week, placebo-controlled trials [one flexibledose (2-15 mg/day) and one fixed-dose (5, 10, or 15 mg/day)] and in one 52-week open-label trial.
Maltese: Irritabilità relatata ma' disturb awtistiku f'pazjenti pedjatriċi (ara sezzjoni 4.2) Aripiprazole kien studjat f'pazjenti li kellhom bejn is-6 u s-17-il sena, f'żewġ provi li damu 8 ġimgħat, ikkontrollati bi plaċebo (waħda b'doża flessibbli (2-15 mg/kuljum) u waħda b'doża fissa (5, 10, jew 15 mg/kuljum)) u prova waħda ta' 52-il ġimgħa open-label.
English: Irritability associated with autistic disorder: the safety and efficacy of Aripiprazole Sandoz in children and adolescents aged below 18 years have not yet been established.
Maltese: Irritabilità relatata ma' disturb awtistiku: is-sigurtà u l-effikaċja ta' Aripiprazole Sandoz fit-tfal u adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Population pharmacokinetic evaluation has revealed no evidence of clinically significant effects from smoking on the pharmacokinetics of aripiprazole.
Maltese: Tipjip Evalwazzjoni farmakokinetika tal-popolazzjoni ma wriet l-ebda evidenza ta' effetti klinikament sinifikanti minn tipjip fuq il-farmakokinetika ta' aripiprazole.
English: • unusual movements (especially of the face or tongue) and reduced level of consciousness.
Maltese: • movimenti mhux tas-soltu (speċjalment tal wiċċ jew l ilsien) u livell mnaqqas ta' koxjenza.
English: At steady state, dehydro-aripiprazole, the active metabolite, represents about 40% of aripiprazole AUC in plasma.
Maltese: Fi stat stabbli, dehydro-aripiprazole, il-prodott tal-metaboliżmu attiv, jagħmel madwar 40 % tal-AUC ta' aripiprazole fil-plasma.