FrancophonIA/ELRC3.0 huggingface dataset:
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 irrispondew li żammew rispons għall-prodott mediċinali għall-52 ġimgħa kien simili fiż-żewġ gruppi (aripiprazole 77% u haloperidol 73%).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: • The other ingredients for 5 mg are crystalline maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, indigo carmine (E132) and magnesium stearate.
Maltese: • Is-sustanzi l-oħra għall-5 mg huma maltosju kristallin, microcrystalline cellulose, lamtu ġelatinizzat minn qabel, croscarmellose sodium, indigo carmine (E132) u magnesium stearate.
English: Blood glucose increased Glycosylated haemoglobin increased Blood glucose fluctuation Increased creatine phosphokinase
Maltese: Żieda fl-emoglobina glycosylated Fluttwazzjoni talglucose fid-demm Żieda fi creatine phosphokinase
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: Ferility
Maltese: Fertilità
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: 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 the placebo-controlled trials, the mean weight gain was 0.4 kg for placebo and 1.6 kg for aripiprazole.
Maltese: Fil-provi kkontrollati bil-plaċebo, iż-żieda medja fil-piż kienet 0.4 kg għall-plaċebo u 1.6 kg għal aripiprazole.
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-enżimi CYP2D6 u CYP3A4 iżda mhux l-enżimi CYP1A.
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: Tardive dyskinesia Dystonia
Maltese: Diskinesija tardiva Distonja
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 ttrattati b'aripiprazole u 53.3% għal pazjenti ttrattati b'haloperidol.
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: Aripiprazole did not impair fertility in reproductive toxicity studies.
Maltese: Aripiprazole ma xekkilx il-fertilità abbażi ta' dejta minn studji ta' tossiċità riproduttiva.
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 kienu 2.4 kg u 5.8 kg u għal plaċebo 0.2 kg u 2.3 kg, rispettivament.
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 iddoża (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: Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/kg, indicating extensive extravascular distribution.
Maltese: Aripiprazole tiġi distribwita b'mod estensiv fil-ġisem, bil-volum medju ta' distribuzzjoni apparenti ta' 4.9 l/kg, li juri tqassim estensiv fis-sistema ekstravaskulari.
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'metaboliti estensivi ta' CYP2D6 u madwar 146 siegħa f'metaboliti inferjuri ta' CYP2D6.
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: • The other ingredients for 10, 30 mg are crystalline maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, iron oxide red (E172) and magnesium stearate.
Maltese: • Is-sustanzi l-oħra għal 10, 30 mg huma maltosju kristallin, microcrystalline cellulose, lamtu ġelatinizzat minn qabel, croscarmellose sodium, iron oxide red (E172) u magnesium stearate.
English: The pharmacokinetics of aripiprazole and dehydro-aripiprazole in paediatric patients 10 to 17 years of age were similar to those in adults after correcting for the differences in body weights.
Maltese: Il-farmakokinetika ta' aripiprazole u dehydro-aripiprazole f'pazjenti pedjatriċi li kellhom minn 10 sa 17-il sena, kienet simili għal dawk fl-adulti wara li ġew ikkoreġuti d-differenzi fil-piżijiet tal-ġisem.
English: Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls.
Maltese: Aripiprazole jista' jikkaġuna ħedla, pressjoni baxxa minħabba l-poża, instabilità motorili u sensorjali, li jistgħu jwasslu għal waqgħat.
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: Aripiprazole Mylan Pharma 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 Mylan Pharma hu indikat għal trattament ta' episodji manijaċi minn moderati sa severi fid-Disturb Bipolari I għal sa 12-il ġimgħa f'adolexxenti li jkollhom 13-il sena u aktar (ara sezzjoni 5.1).
English: Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria)
Maltese: Reazzjoni allerġika (eż. reazzjoni anafilattika, anġjoedema li tinkludi lsien minfuħ, edema flilsien, edema tal-wiċċ, ħakk, jew urtikarja)
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: u b'mod inqas qawwi mar-reċetturi tad-dopamina D4, tas-serotonina 5-HT2C u 5-HT7, α1-adrenerġiki u H1 istamina.
English: In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who achieved remission on aripiprazole during a stabilization phase prior to randomisation, aripiprazole demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into depression.
Maltese: Fi prova kkontrollata bi plaċebo ta' 26 ġimgħa, segwita b'estensjoni ta' 74 ġimgħa, f'pazjenti manijaċi li rċievew remissjoni fuq aripiprazole matul fażi ta' stabilizzazzjoni qabel randomizzazzjoni, aripiprazole wera superjorità fuq plaċebo fil-prevenzjoni ta' rikorrenza bipolari, primarjament filprevenzjoni ta' rikorrenza f'manija iżda naqas li juri s-superjorità fuq plaċebo fil-prevenzjoni ta' rikorrenza f'depressjoni.
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: Photosensitivity reaction Alopecia
Maltese: Reazzjoni tassensittività għad-dawl Alopeċja
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 tipprevjeni r-rikorrenza ta' episodji manijaċi f'pazjenti li kienu qegħdin jirċievu aripiprazole, bħala monoterapija jew terapija kkombinata, kompli bit-terapija bl-istess doża.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Extrapyramidal symptoms (EPS) Schizophrenia: in a long term 52-week controlled trial, aripiprazoletreated 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: 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 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: 4.7 Effects on ability to drive and use machines 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: Other symptoms may include:
Maltese: Sintomi oħra jistgħu jinkludu:
English: The incidences of the Adverse Drug Reactions (ADRs) associated with aripiprazole therapy are tabulated below.
Maltese: L-inċidenzi ta' Reazzjonijiet Avversi tal-Mediċina (ADRs) assoċjati ma' terapija b'aripiprazole huma miġbura f'tabella hawn taħt.
English: LIST OF EXCIPIENTS Contains maltose.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Fih maltosju.
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: Aripiprazole Mylan Pharma 30 mg tablets are pink, oval and biconvex of 17.1mm in length, 8.1 mm in width, engraved with ‘30' on one side.
Maltese: Pilloli Aripiprazole Mylan Pharma 30 mg huma roża, ovali u bikonvessi ta 17.1 mm fit-tul, 8.1 mm filwisa', imnaqqxa bil “30” fuq naħa waħda.
English: Patients with ADHD comorbidity
Maltese: Pazjenti b'komorbidità ta' ADHD
English: This difference was not statistically significant.
Maltese: Din id-differenza ma kenitx statistikament sinifkanti.
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 30 mg of aripiprazole.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola għandha 30 mg ta' aripiprazole.
English: Aripiprazole Mylan Pharma 30 mg tablets
Maltese: Aripirprazole Mylan Pharma 30 mg pilloli aripiprazole
English: Aripiprazole Mylan Pharma contains maltose
Maltese: Aripiprazole Mylan Pharma fih maltosju
English: • reports of abnormal liver test values,
Maltese: • rapporti ta' valuri anormali ta' testijiet tal-fwied,
English: Patients treated with any antipsychotic, 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, 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: NAME OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S
Maltese: FIS-SUQ Mylan S.A.S
English: STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 5 mg of aripiprazole.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola għandha 5 mg ta' aripiprazole.
English: Patients were 6 - 18 years and presented an average score of 29 on TTS-YGTSS at baseline.
Maltese: Il-pazjenti kienu minn 6 snin - 18-il sena u ppreżentaw punteġġ medju ta' 29 fit-TTS-YGTSS fil-linja bażi.
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): 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: 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): 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: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (li jistgħu jaffettwaw sa persuna 1 f'100):
English: • life-threatening irregular heartbeat,
Maltese: • taħbit irregolari tal-qalb ta' theddida għall-ħajja,
English: • baldness,
Maltese: • sturdament,
English: Comparisons between aripiprazole and placebo in the proportions of patients experiencing potentially clinically significant changes in routine laboratory and lipid parameters (see section 5.1) revealed no medically important differences.
Maltese: Meta wieħed iqabbel aripiprazole mal-plaċebo fuq il-proporzjon tal-pazjenti li wrew tibdil klinikament importanti fit-testijiet tal-laboratorju u f'parametri lipidi (ara sezzjoni 5.1) ma dehret l-ebda differenza importanti klinikament.
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: Concomitant administration of aripiprazole and other inducers 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 St.
English: Headache Sedation Somnolence Dizziness
Maltese: Ipergliċemija u dijabete mellitus
English: Aripiprazole Mylan Pharma contains the active substance aripiprazole and belong to a group of medicines called antipsychotics.
Maltese: Aripiprazole Mylan Pharma fih is-sustanza attiva aripiprazole u jappartjeni għal grupp ta' mediċini msejħa antipsikotiċi.
English: Doses higher than 10 mg/day should therefore only be used in exceptional cases and with close clinical monitoring (see sections 4.4, 4.8 and 5.1).
Maltese: Għalhekk dożi ogħla minn 10 mg/kuljum għandhom jintużaw biss f'każijiet eċċezzjonali u monitoraġġ kliniku mill-qrib (ara sezzjonijiet 4.4, 4.8 u 5.1).
English: • light-headedness,
Maltese: • infjammazzjoni tal-fwied,
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: 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 CYP2D6 poor metabolisers, concomitant use of strong inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.
Maltese: F'metabolizzaturi batuti ta' CYP2D6, l-użu fl-istess waqt ta' impedituri qawwija ta' CYP3A4 jista' jirriżulta f'konċentrazzjoni ogħla ta' aripiprazole fil-plażma, meta mqabbel ma' dak ta' metabolizzaturi estensivi ta' CYP2D6.
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: Aripiprazole Mylan Pharma 5 mg tablets Indigo carmine (E132) Aripiprazole Mylan Pharma 10 mg tablets Iron Oxide Red (E172) Aripiprazole Mylan Pharma 15 mg tablets Iron Oxide Yellow (E172) Aripiprazole Mylan Pharma 30 mg tablets Iron Oxide Red (E172) 6.2 Incompatibilities Not applicable.
Maltese: Aripiprazole Mylan Pharma 5 mg pilloli Indigo karminju aluminju aħmar skur (E132) Aripiprazole Mylan Pharma 10 mg pilloli
English: • fainting,
Maltese: • remettar,
English: In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
Maltese: Fi provi kliniċi, ġew irrapportati xi każijiet rari ta' NMS waqt it-trattament b'aripiprazole.
English: • difficulty swallowing,
Maltese: • insuffiċjenza tal-fwied,
English: Increased Alanine Aminotransferase (ALT) Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Maltese: Żieda f'Gamma Glutamyl Transferase (GGT)