FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary end-point 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 aripiprazole (n = 18, or 13 % of evaluable patients), compared to 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 għallpunt 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: 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 skiżofrenja, kien hemm differenza statistikament sinifikanti fir-rata ta' rkadar ta' sintomi psikotiċi bejn il-gruppi ta' aripiprazole (19.
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 skiżofrenja kronika, l aripiprazole orali kellu tnaqqis sinifikament akbar fir-rata ta' pazjenti li rkadew, 34 % fil-grupp ta'aripiprazole orali u 57 % fil-plaċebo.
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' dawk ikkurati b'haloperidol (57.3 %).
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: 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 % ta' l-AUC ta' aripiprazole fil-plasma.
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: 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: Aripiprazole Accord 10 mg/ 30 mg tablets
Maltese: Aripiprazole Accord 10 mg/ 30 mg pilloli
English: Talk to your doctor before taking Aripiprazole Accord
Maltese: Mediċini oħra u Aripiprazole Accord
English: Each 10 mg tablet contains 59 mg lactose (as monohydrate).
Maltese: Kull pillola ta' 10 mg fiha 59 mg lactose (bħala monohydrate).
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 flexible-dose (2-15 mg/day) and one fixed-dose (5, 10, or 15 mg/day)] and in one 52-week open-label 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: Concomitant administration of aripiprazole and other stronginducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects and similar dose increases should therefore be applied.
Maltese: (bħal rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine u ipericum (St.
English: Each 5 mg tablet contains 63 mg lactose (as monohydrate).
Maltese: Kull pillola ta' 5 mg fiha 63 mg lactose (bħala monohydrate).
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: 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: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12
Maltese: Psikolettiċi, Kodiċi ATC:
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: In schizophrenia patients the incidence of akathisia was 6.2 % with aripiprazole and 3.0 % with placebo.
Maltese: F'pazjenti bi skiżofrenja, l-inċidenza ta' akatisja kienet ta' 6.2 % b'aripiprazole u 3.0 % bi plaċebo.
English: Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema,
Maltese: Reazzjoni allerġika (eż. reazzjoni anafilattika, anġjoedima li tinkludi lsien minfuħ, edima tal-ilsien, edima tal-wiċċ, ħakk, jew urtikarja)
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 għallgalactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
Maltese: Aripiprazole Accord hu indikat għal trattament ta' episodji manijaċi minn moderati sa severi fidDisturb Bipolari I għal sa 12-il ġimgħa f'adolexxenti li jkollhom 13-il sena u aktar (ara sezzjoni 5.1).
English: Aripiprazole Accord contains lactose
Maltese: Aripiprazole Accord fih lactose
English: In the adolescent (13-17 years) schizophrenia population with aripiprazole exposure of 5 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: Fil-popolazzjoni ta' adolexxenti (1317-il sena) bi skiżofrenja b'esponiment għal aripiprazole ta' 5 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: 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 qawwija oħra ta' CYP2D6, bħal fluoxetine u paroxetine jistgħu jkunu mistennija li jkollhom effetti simili u għalhekk tnaqqis simili fid-doża għandu jiġi applikat.
English: Stiffness
Maltese: Irrekwitezza
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: The rate of death in aripiprazole-treated patients was 3.5 % compared to 1.7 % in the placebo group.
Maltese: Ir-rata ta' mwiet f'pazjenti fuq kura b'aripiprazole kienet 3.5 % imqabbla ma' 1.7 % fil-grupp ta' plaċebo.
English: • diabetes mellitus,
Maltese: • dijabete melittus,
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: 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: Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13-17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo):
Maltese: Skiżofrenja f'adolexxenti li għandhom 15-il sena jew aktar Fi prova klinika li damet żmien qasir, ikkontrollata bil-plaċebo, li kienet tinvolvi 302 adolexxenti (minn 13-17-il sena) li kellhom skiżofrenja, il-frekwenza u t-tip ta' reazzjonijiet avversi kienu simili għal dawk fl-adulti, ħlief għal dawn ir-reazzjonijiet li ġejjin li kienu rrappurtati b'mod iktar frekwenti fl-adolexxenti li kienu qed jirċievu aripiprazole milli fl-adulti li kienu qed jirċievu aripiprazole (u iktar b'mod frekwenti mill-plaċebo):
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 komkomitanti ta'carbamazepine, induttur qawwi ta' CYP3A4, u aripiprazole orali lil pazjenti bi skiżofrenja jew b'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: INFORMATION IN BRAILLE Aripiprazole Accord 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Accord 5 mg
English: In a sub-analysis of the adolescent patients between the ages of 15 to 17 years, representing 74 % of the total enrolled population, maintenance of effect was observed over the 26-week open-label extension trial.
Maltese: F'sottoanaliżi ta' pazjenti adolexxenti bejn l-etajiet ta' 15 sa 17-il sena, li jirrappreżentaw 74 % tal-popolazzjoni totali rreġistrata, iż-żamma tal-effett kienet osservata matul il-prova ta' estensjoni open-label, li damet 26 ġimgħa.
English: Irritability associated with autistic disorder: the safety and efficacy of Aripiprazole Accord in children and adolescents aged below 18 years have not yet been established.
Maltese: Irritabilità marbuta ma' disturb awtistiku: is-sigurtà u effikaċja ta' Aripiprazole Accord fit-tfal u adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: Aripiprazole Accord 30 mg tablets
Maltese: Aripiprazole Accord 30 mg pilloli
English: In a clinical trial in healthy subjects, a stronginhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63 % and 37 %, respectively.
Maltese: (ketoconazole) żied l-AUC u sCmax ta' aripiprazole b'63% u 37 % rispettivament.
English: Tics associated with Tourette's disorder: the safety and efficacy of Aripiprazole Accord 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' Aripiprazole Accord fit-tfal u adolexxenti bejn 6 snin u 18-il sena ma ġewx determinati s'issa.
English: INFORMATION IN BRAILLE Aripiprazole Accord 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Accord 10 mg
English: INFORMATION IN BRAILLE Aripiprazole Accord 15 mg 17.
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Accord 30 mg 17.
English: In the paediatric bipolar population (10-17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/ml) and males (< 2 ng/ml) was 28.0 % and 53.3 %, respectively.
Maltese: Fil-popolazzjoni bipolari pedjatrika (10-17-il sena) b'esponiment sa 30 ġimgħa, l-inċidenza ta' livelli baxxi ta' prolactin fis-serum fin-nisa (< 3 ng/ml) u fl-irġiel (< 2 ng/ml) kienet 28.0 % u 53.3 % rispettivament.
English: In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic adult patients, presenting with positive or negative symptoms, 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: Pathological gambling Impulse-control disorders Binge eating
Maltese: Logħob patoloġiku tal-azzard Disturbi tal-kontroll tal-impuls Teħid ta' ikel bla rażan Xiri kompulsiv
English: In a 6-week placebo-controlled trial involving 302 schizophrenic adolescent patients (13-17 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: Aripiprazole Accord 10 mg tablets
Maltese: Aripiprazole Accord 10 mg pilloli
English: Aripiprazole Accord 15 mg tablets
Maltese: Aripiprazole Accord 15 mg pilloli
English: Less than 1 % of unchanged aripiprazole was excreted in the urine and approximately 18 % was recovered unchanged in the faeces.
Maltese: Inqas minn 1 % ta' aripiprazole mhux imbiddel tneħħa fl-awrina u bejn wieħed u ieħor 18 % inġabar mhux mibdul flippurgar.
English: Aripiprazole Accord 5 mg tablets are blue colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A5” on one side and another side is plain.
Maltese: Aripiprazole Accord 5 mg pilloli huma pilloli mhux miksijin, bikonvessi, b'forma rettangolari modifikata, b'wisa' ta' madwar 4.6 mm, b'tul ta' madwar 8.1 mm, ta' kulur blu, b'“A5” imnaqqxa fuq naħa minnhom u bin-naħa l-oħra sempliċi.
English: Aripiprazole Accord 5 mg tablets
Maltese: Aripiprazole Accord 5 mg pilloli
English: Adjunctive aripiprazole demonstrated superiority over placebo on the secondary outcome measure, CGI-BP Severity of Illness score (mania).
Maltese: L-għoti ta' aripiprazole bħala mediċina addizzjonali aġġuntiv wera superjoritaà fuq il-plaċebo fuq il-kejl tar-riżultat sekondarju, il-punteġġ tas-Sseverità tal-Mmarda CGI-BP (manija).
English: Aripiprazole Accord 10 mg tablets are pink colored, approximately 8.1 mm in length, 4.6 mm in width, modified rectangle shaped, biconvex, uncoated tablets, debossed with “A10” on one side and another side is plain.
Maltese: Aripiprazole Accord 10 mg pilloli huma pilloli mhux miksija, bikonvessi, b'forma rettangolari modifikata, b'wisa' ta' madwar 4.6 mm, b'tul ta' madwar 8.1 mm, ta' kulur roża, b'“A10” imnaqqxa fuq naħa minnhom u bin-naħa l-oħra sempliċi.
English: At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99 % bound to serum proteins, binding primarily to albumin.
Maltese: F'konċentrazzjonijiet terapewtiċi, aripiprazole u dehydro-aripiprazole jintrabtu b'iktar minn 99 % mal-protejini tad-demm, u jintrabtu laktar ma' l-albumina.
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 (may affect more than 1 in 10 people) 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 (may affect up to 1 in 10 people).
Maltese: Effetti sekondarji addizzjonali fit-tfal u l-adolexxenti 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 (jistgħu jaffettwaw aktar minn pazjent 1 minn kull 10) u wġigħ fil-parti ta' fuq tal-addome, ħalq xott, żieda fir-rata ta' taħbit talqalb, żieda fil-piż, żieda fl-aptit, kontrazzjonijiet tal-muskoli, movimenti mhux ikkontrollati taddirgħajn u tas-saqajn, u sensazzjoni ta' sturdament, speċjalment meta tqum bilwieqfa meta tkun mimdud/a jew bilqiegħda, kienu komuni (jistgħu jaffettwaw sa pazjent 1 minn kull 10).
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: .7 Effetti fuq il-ħila biex issuq u tħaddem magni Aripiprazole għandu effett żgħir sa effett moderat fuq il-ħila biex issuq u tħaddem magni minħabba lpossibbiltà ta' effetti fuq is-sistema nervuża u effetti viżwali, bħal sedazzjoni, ħedla, sinkope, vista mċajpra, diplopja (ara sezzjoni 4.8).
English: Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for muscarinic receptors.
Maltese: Madankollu, ġew irrapurtai wkoll żidiet ta' kreatinina fosfoinejż u rabdomajoliżi, mhux neċessarjemant assoċjati ma' NMS.
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: Manic episodes in Bipolar I Disorder: the recommended starting dose for Aripiprazole Accord is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Maltese: Episodji manijaċi f'Disturb Bipolari I: id-doża rakkomandata tal-bidu għal Aripiprazole Accord hija 15 mg mogħtija fuq skeda ta' darba kuljum fuq stonku vojt jew fuq stonku mimli bħala monoterapija jew bħala terapija ta' kombinazzjoni (ara sezzjoni 5.1).
English: In the pooled adolescent schizophrenia population (13-17 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 (13-17-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 flirġiel (< 2 ng/ml) kienet ta' 29.5 % u ta' 48.3 % respettivament.
English: Aripiprazole Accord 15 mg tablets are yellow colored, approximately 7.14 mm in diameter, round shaped, bevelled edge, biconvex, uncoated tablets, debossed with “A15” on one side and another side is plain.
Maltese: Aripiprazole Accord 15 mg pilloli huma pilloli mhux miksija, bikonvessi, b'xifer imżerżaq, b'forma tonda, b'dijametru ta' madwar 7.14 mm, ta' kulur isfar, b'“A15” imnaqqxa fuq naħa minnhom u binnaħa l-oħra sempliċi.
English: Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Maltese: Aripiprazole Accord hu indikat għal trattament ta' skiżofrenja fl-adulti u fl-adolexxenti minn età ta' 15-il sena jew aktar.
English: In two long term trials with adolescent (13-17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 37.0 % and 59.4 %, respectively.
Maltese: F'żewġ provi b'terminu ta' żmien twil b'pazjenti adolexxenti (13-17-il sena) skiżofreniċi u bipolari ttrattati b'aripiprazole, l-inċidenza ta' livelli baxxi ta' prolactin fis-serum fin-nisa (< 3 ng/ml) u flirġiel (< 2 ng/ml) kienet 37.0% u 59.4, rispettivament.
English: Aripiprazole Accord 5/10/15 mg tablets are available in HDPE bottle with PPCRC closure containing 30 or 100 tablets.
Maltese: Aripiprazole Accord 5/10/15 mg pilloli jiġu bħala flixkun HDPE b'tapp PPCRC li fih 30 jew 100 pillola.
English: In a long term 26-week placebo-controlled trial, the incidence of EPS was 19 % for aripiprazole-treated patients and 13.1 % for placebo-treated patients.
Maltese: Fi studju fit-tul ta' 26 ġimgħa kkontrollat minn plaċebo, linċidenza ta' EPS kienet 19 % għall-pazjenti ikkurati b'aripiprazole u 13.1 % għall-pazjenti ikkurati bil-plaċebo.