FrancophonIA/ELRC3.0 huggingface dataset:
English: • Tricyclic's (such as clomipramine and amitriptyline) used for depressive illness
Maltese: • triċikliċi (bħal clomipramine u amitriptyline) użati għal mard depressiv
English: Oesophageal dysmotility and aspiration have been associated with the use of antipsychotics, including aripiprazole.
Maltese: Dismotilità tal-esofagu u aspirazzjoni ġew assoċjati mal-użu ta' antipsikotiċi, li jinkludu aripiprazole.
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-reċetturi tad-dopamina D2 u D3, tas-serotonina 5-HT1A u 5-HT2A, u b'mod inqas qawwi mar-reċetturi tad-dopamina D4, tas-serotonina 5-HT2C u 5-HT7, α1-adrenerġiki u H1 istamina.
English: • abnormal muscle breakdown which can lead to kidney problems,
Maltese: • kollass mhux normali tal-muskoli li jista' jwassal għal problemi fil-kliewi,
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: burdata fil-parti tal-istudju d-driegħ tal-kura fejn ingħatat mediċina addizzjonalit-trattament aġġuntiv kienu 16 % f'aripiprazole + lithium u 18 % f'aripiprazole + valproate meta mqabblal ma' 45 % fi talplaċebo + lithium u 19 % fi tal-plaċebo + valproate.
English: Potential for aripiprazole to affect other medicinal products 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 t'aripiprazole ta' 10-30 mg/jum ma kellhom l-ebda effett ta' importanza fuq ilmetaboliżmu tas-sustanzi li jaħdmu fuqhom is-CYP2D6 (dextromethorphan/3-methoxymorphinan ratio), CYP2C9 (warfarin), CYP2C19 (omeprazole), u CYP3A4
English: • Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
Maltese: • mediċini li jikkoreġu r-ritmu tal-qalb (bħal quinidine, amiodarone, flecainide)
English: Aspiration pneumonia Laryngospasm Oropharyngeal spasm
Maltese: Pnewmonja minn aspirazzjoni Laringospażmu Spażmu orofarinġeali
English: Fertility Aripiprazole did not impair fertility based on data from reproductive toxicity studies.
Maltese: Fertilità Aripiprazole ma xekkilx il-fertilità abbażi ta' dejta minn studji ta' tossiċità riproduttiva.
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: F'analiżi tas-sottogrupp il-punt ta' stima tal-HR kien 0.495 għal individwi ta' bejn 13 sa 14-il sena meta mqabbel ma' 0.454 fost dawk ta' 15 sa 17-il sena.
English: Kaplan-Meier relapse rates at week 16 were 35% for aripiprazole and 52% for placebo; the hazard ratio for relapse within 16 weeks (aripiprazole/placebo) was 0.57 (non-statistically significant difference).
Maltese: Ir-rati ta' rikaduta Kaplan-Meier f'ġimgħa 16 kienu ta' 35 % għal aripiprazole u ta' 52 % għal plaċebo; ilproporzjon ta' periklu ta' rikaduta fi żmien 16-il ġimgħa (aripiprazole/plaċebo) kien ta' 0.57 (differenza mhux statistikament sinifikanti).
English: Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Maltese: Żieda fil-gamma glutamyl transferase (GGT) Żieda fl-alkaline phosphatase
English: Rhabdomyolysis Myalgia Stiffness
Maltese: Rabdomijoliżi Mijalġja Ebusija
English: Pack size: 14, 28, 49, 56, or 98 tablets Not all pack sizes may be marketed.
Maltese: Daqs tal-pakkett: 14, 28, 49, 56, jew 98 pillola Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: • Rapid heartbeat, agitation/aggressiveness, problems with speech.
Maltese: • taħbit mgħaġġel tal-qalb, aġitazzjoni/aggressività, problemi fit-taħdit.
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 (Kreatina Fosfokinejż), ġeneralment li tgħaddi u asintomatika, kienu osservati f'3.5 % tal-pazjenti kkurati b'aripiprazole meta mqabbla ma' 2.0 % talpazjenti li rċevew plaċebo.
English: Aripiprazole Zentiva 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 Zentiva hu indikat għat-trattament ta' episodji manijaċi minn moderati sa severi f'Disturb Bipolari I u biex jiġi evitat episodju manijaku ġdid f'adulti li kellhom l-aktar episodji manjaċi u li lepisodji manijaċi tagħhom irrispondew għal trattament b'aripiprazole (ara sezzjoni 5.1).
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 waqfienfejqan sostnut (punteġġi totali ta' ≤ 12 għal Y-MRS u MADRS) b'aripiprazole (10 mg/kuljum sa 30 mg/kuljum) bħala mediċina addizzjonaliaġġuntiv mal- għal lithiumju jew valproate għal 12-il ġimgħa konsekuttiva, l-għoti ta' aripiprazole bħala mediċina addizzjonaliaġġuntiv wera superjorità fuq ilplaċebo b'riskju mnaqqas ta' 46 % (proporzjon ta' periklu ta' 0.54) fil-prevenzjoni ta' sabiex ixejjen ir-rikorrenza bipolari u riskju mnaqqas ta' 65 % (proporzjon ta' periklu ta' 0.35) fil-prevenzjoni ta'sabiex ixejjen rikorrenza għal rikorrenza ta' manija meta mqabbel mal-plaċebo li ngħata bħala mediċina addizzjonali, aġġuntiv imma naqas li juri superjorità fuq il-plaċebo fil-prevenzjoni ta' biex ixejjen ir-rikorrenza għal 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 is-skizofrenja u Disturb Bipolari I hija medjatur bejn taħlita ta' agoniżmu parzjali tar-reċetturi dopamina D2 u serotonina 5-HT1A, u antagoniżmu tarreċetturi serotonina 5-HT2A.
English: • Other anti-depressants (such as venlafaxine and tryptophan) used in major depression
Maltese: • antidipressanti oħra (bħal venlafaxine u trytophan) użati għal depressjoni maġġuri
English: Each tablet contains 5 mg/10 mg/15 mg/30 mg of aripiprazole.
Maltese: Kull pillola fiha 5 mg/10 mg/15 mg/30 mg ta' aripiprazole.
English: The incidence of hyperprolactinaemia or increased serum prolactin in patients treated with aripiprazole (0.3%) was similar to that of placebo (0.2%).
Maltese: L-inċidenza ta' iperprolaktinimija jew żieda ta' prolaktin fis-serum f'pazjenti trattati b'aripiprazole (0.3 %) kienet simili għal dik tal-plaċebo (0.2 %).
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 talprotease ta' HIV huma mistennija li jkollhom effetti simili u tnaqqis simili fid-doża għandu, għalhekk jiġi applikat (ara sezzjoni 4.2).
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: Bil-kuntrarju l-intervall tal-kunfidenza ta' 95% għall-HR fis-sottogrupp ta' etajiet akbar (aripiprazole, 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: • Triptans (such as sumatriptan and zolmitripitan) used for treating migraine
Maltese: • triptans (bħal sumatriptan u zolmitripitan) użati għal trattament ta' emigranja
English: Excipient with known effect: each orodispersible tablet contains 55.5 mg of lactose (as monohydrate) and 1.97 mg of sodium.
Maltese: Eċċipjent b'effett magħruf: kull pillola li tinħall fil-ħalq fiha 55.5 mg ta' lactose (bħala monohydrate) u ta' 1.97 mg sodium.
English: Excipient with known effect: each tablet contains 198 mg of lactose (as monohydrate) and 5.62 mg of sodium.
Maltese: Eċċipjent b'effett magħruf: kull pillola fiha 198 mg ta' lactose (bħala monohydrate) u ta' 5.62 mg sodium.
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, impeditur qawwi tas-CYP2D6 (quinidine) żied l-AUC ta' aripiprazole b' 107 % waqt li Cmax ma tbiddilx.
English: Hepatic failure Hepatitis
Maltese: Indeboliment epatiku
English: Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Maltese: Aripiprazole Zentiva hu indikat għat-trattament tal-iskiżofrenija fl-adulti u adolexxenti b'età ta' 15-il sena jew aktar.
English: Neuroleptic Malignant Syndrome (NMS) Grand mal convulsion Serotonin syndrome Speech disorder
Maltese: Konvulżjoni grand mal Sindromu ta' serotonin Disturb fid-diskors
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 skizofrenja, kien hemm differenza statistikament sinifikanti fir-rata ta' rkadar ta' sintomi psikotiċi bejn il-gruppi ta' aripiprazole (19.
English: The safety profile in a 26-week open-label extension trial was similar to that observed in the shortterm, placebo-controlled trial.
Maltese: Il-profil tas-sigurtà fil-prova ta' estensjoni open-label, li damet 26 ġimgħa, kien simili għal dak osservat fil-prova li damet żmien qasir, ikkontrollata bil-plaċebo.
English: All ADRs are listed by system organ class 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 mniżżla skont is-sistema tal-klassifika tal-organi u 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 magħrufa (<(ma tistax tittieħed stima mid-dejta disponibbli).
English: In a haloperidol-controlled trial, the proportion of responder patients maintaining response to medicinal product at 52-weeks was similar in both groups (aripiprazole 77% and haloperidol 73%).
Maltese: Waqt prova kkontrollata b'haloperidol, il-proporzjon tal-pazjenti li rrispondew li żammew rispons għall-prodott mediċinali għall-52 ġimgħa kien simili fiż-żewġ gruppi (aripiprazole 77 % u haloperidol 73 %).
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 irrappurtaw reazzjonijiet avversi ċerebrovaskulari mqabbla ma' 0.6 % ta' pazjenti kkurati bil-plaċebo f'dawn il-provi.
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: Skizofrenja: 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: In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated patients and 15.1% for olanzapine-treated 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: Excipient with known effect: each tablet contains 33 mg of lactose (as monohydrate) and 0.94 mg of sodium.
Maltese: Eċċipjent b'effett magħruf: kull pillola għandha 33 mg ta' lactose (bħala monohydrate) u ta' 0.94 mg sodium.
English: Aripiprazole showed an improvement on TTS-YGTSS change from baseline to week 8 of 13.35 for the low dose group (5 mg or 10 mg) and 16.94 for the high dose group (10 mg or 20 mg) as compared with an improvement of 7.09 in the placebo group.
Maltese: Aripiprazole wera titjib fuq il-bidla TTS-YGTSS mil-linja bażi sa Ġimgħa 8 ta' 13.35 għall-grupp ta' doża baxxa (5 mg jew 10 mg) u 16.94 għall-grupp ta' doża għolja (10 mg jew 20 mg) meta mqabbel ma' titjib ta' 7.09 fil-grupp tal-plaċebo.
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' kulur lipofuscin u/jew telf ta' ċelloli parenkimali) f'firien wara 104 ġimgħa fuq doża ta' 20 sa 60 mg/kg/jum (3 sa 10 darbiet aqwa mill-medja fi stat stabbli ta' l-AUC fl-akbar 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 ta' l-AUC fi stat stabbli fid-doża massima rakkomandata fil-bnedmin).
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 baxx 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: In schizophrenia patients the incidence of akathisia was 6.2% with aripiprazole and 3.0% with placebo.
Maltese: F'pazjenti bi skizofrenja, l-inċidenza ta' akatisja kienet ta' 6.2 % b'aripiprazole u 3.0 % bi plaċebo.
English: LIST OF EXCIPIENTS Contains lactose and sodium.
Maltese: TA' EĊĊIPJENTI Fih lactose monohydrate u sodium.
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 ħafna dożi ta' 25 sa 125 mg/kg/jum millħalq (1 sa 3 darbiet iktar mill-medja ta' l-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: Aripiprazole Zentiva 5 mg tablets Aripiprazole Zentiva 10 mg tablets Aripiprazole Zentiva 15 mg tablets Aripiprazole Zentiva 30 mg tablets aripiprazole
Maltese: Aripiprazole Zentiva 5 mg pilloli Aripiprazole Zentiva 10 mg pilloli Aripiprazole Zentiva 15 mg pilloli Aripiprazole Zentiva 30 mg pilloli aripiprazole
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 bil-plaċebo f'pazjenti adulti stabbilizzati, bi skizofrenja kronika, aripiprazole orali kellu tnaqqis sinifikament akbar fir-rata ta' pazjenti li rkadew, 34 % fil-grupp ta' aripiprazole orali u 57 % fil-plaċebo.
English: Excipient with known effect: each tablet contains 66 mg of lactose (as monohydrate) and 1.87 mg of sodium.
Maltese: Eċċipjent b'effett magħruf: kull pillola għandha 66 mg ta' lactose (bħala monohydrate) u ta' 1.87 mg sodium.
English: Aripiprazole demonstrated statistically superior efficacy compared to placebo on the Aberrant Behaviour Checklist Irritability subscale.
Maltese: Aripiprazole wera effikaċja statistikament superjuri meta mqabbel mal-plaċebo fuq is-sottoskala talIrritabilità tal-Lista tal-Iċċekkjar tal-Imġiba Aberranti.
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, acesulfame potassium, mango flavour, magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, acesulfame potassium, mango flavour, magnesium stearate.
English: Aripiprazole Zentiva 10 mg, 30 mg orodispersible tablets: The score line is not intended for breaking the tablet.
Maltese: Aripiprazole Zentiva 10 mg, 30 mg: Is-sinjal imnaqqax mhuwiex intiż biex tinqasam il-pillola.
English: In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo.
Maltese: Fi provi kkontrollati bi plaċebo, l-inċidenza ta' akatisja f'pazjenti bipolari kienet ta' 12.1 % b'aripiprazole u 3.2 % bi plaċebo.
English: Recurrence prevention of manic episodes in Bipolar I Disorder For preventing recurrence of manic episodes in patients who have been receiving aripiprazole as monotherapy or combination therapy, continue therapy at the same dose.
Maltese: Il-prevenzjoni ta' rikorrenza ta' episodji manijaċi f'Disturbi Bipolari I Biex tiġi evitata r-rikorrenza ta' episodji manijaċi f'pazjenti li kienu qegħdin jirċievu aripiprazole, bħala monoterapija jew terapija kkombinata, kompli t-terapija bl-istess doża.
English: Aripiprazole Zentiva 5 mg tablets Aripiprazole Zentiva 10 mg tablets Aripiprazole Zentiva 15 mg tablets Aripiprazole Zentiva 30 mg tablets
Maltese: Aripiprazole Zentiva 5 mg pilloli Aripiprazole Zentiva 10 mg pilloli Aripiprazole Zentiva 15 mg pilloli Aripiprazole Zentiva 30 mg pilloli
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,
Maltese: Episodji manijaċi f'Disturb Bipolari I f'adolexxenti li għandhom 13-il sena u aktar 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 (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: 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: • uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
Maltese: • movimenti mhux ikkontrollati tal-ħalq, l-ilsien u dirgħajn/riġlejn (diskajnisja tardiva),
English: Pancreatitis Dysphagia
Maltese: Pankreatite Disfaġja Dijarea
English: Hepatobiliary disorders
Maltese: Pankreatite Disfaġja
English: The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
Maltese: Is-sinjali u s-sintomi rrappurtati li possibbilment huma medikament serji kienu jinkludu ħedla ta' rqad, telf temporanju missensi u sintomi ekstrapiramidali.
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 flexible-dose (2 - 15 mg/day) and one fixed-dose (5, 10, or 15 mg/day)] and in one 52-week openlabel trial.
Maltese: Irritabilità marbuta 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 bil-plaċebo (wieħed b'doża flessibbli (2-15 mg/kuljum) u wieħed b'doża fissa (5, 10, jew 15 mg/kuljum)) u prova waħda ta' 52-il ġimgħa open-label.
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium, magnesium stearate.
English: Excipient with known effect: each tablet contains 99 mg of lactose (as monohydrate) and 2.81 mg of sodium.
Maltese: Eċċipjent b'effett magħruf: kull pillola għandha 99 mg ta' lactose (bħala monohydrate) u ta' 2.81 mg sodium.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew assorbiment ħażin tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Manic episodes in Bipolar I Disorder in children and adolescents Aripiprazole was studied in a 30-week placebo-controlled trial involving 296 children and adolescents (10 - 17 years), who met DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a Y-MRS score ≥ 20 at baseline.
Maltese: Episodji manijaċi f'Disturb Bipolari I fi tfal u f'adolexxenti Aripiprazole ġie studjat fi prova kkontrollata bil-plaċebo li damet 30 ġimgħa li kienet tinvolvi 296 tfal u adolexxenti (10-17-il sena) li kienu ssodisfaw il-kriterji tad-DSM-IV għal Disturb Bipolari I b'episodji manijaċi jew imħallta bi jew mingħajr karatteristiċi psikotiċi u li kellhom punteġġ Y-MRS ta' ≥ 20 fil-linja bażi.
English: Excipient with known effect: each orodispersible tablet contains 111 mg of lactose (as monohydrate) and 3.93 mg of sodium.
Maltese: Eċċipjent b'effett magħruf: kull pillola li tinħall fil-ħalq fiha 111 mg ta' lactose (bħala monohydrate) u ta' 3.93 mg sodium.