FrancophonIA/ELRC3.0 huggingface dataset:
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, yellow iron oxide.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, yellow iron oxide.
English: Aripiprazole Sandoz 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 Sandoz hu indikat għall-kura 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: Drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Sindromu fit-trabi ta' waqfien ta' mediċini jew drogi (ara sezzjoni 4.6)
English: Aripiprazole Sandoz 20 mg tablets EU/1/15/1029/043 (14 tablets) EU/1/15/1029/044 (28 tablets) EU/1/15/1029/045 (49 tablets) EU/1/15/1029/046 (56 tablets) EU/1/15/1029/047 (98 tablets)
Maltese: Aripiprazole Sandoz 20 mg pillola EU/1/15/1029/043 (14-il pillola) EU/1/15/1029/043 (28 pillola) EU/1/15/1029/043 (49 pillola) EU/1/15/1029/043 (56 pillola) EU/1/15/1029/043 (98 pillola)
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 bi plaċebo li fihom kienu involuti 1,228 pazjent adult skizofreniku li wrew sintomi pożittivi jew negattivi, aripiprazole orali kien assoċjat ma' titjib statistikament sinifikanti akbar fis-sintomi psikotiċi meta mqabbla mal-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-amministrazzjoni komkomitanti ta'carbamazepine, stimulant qawwi ta' CYP3A4, u aripiprazole mill-ħalq għal pazjenti b'skizofrenija jew disturb skiżoaffettiv, il-medja ġeometrika tasCmax u l-AUC għal aripriprazole kienu ta' 68 % u 73 % iktar baxxi, rispettivament, meta mqabbla ma dik fil-pazjenti fejn aripiprazole (30 mg) ġie mogħti waħdu.
English: Excipient(s) with known effect 132.33 mg lactose monohydrate per tablet.
Maltese: 132.33 mg lactose monohydrate kull pillola.
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
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 (13-17-il sena) bi skizofrenija 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: However, the concentrations of the sulphate conjugates of hydroxy aripiprazole in human bile at the highest dose proposed, 30 mg per day, were no more than 6% of the bile concentrations found in the monkeys in the 39-week study and are well below (6%) their limits of in vitro solubility.
Maltese: Iżda l-konċentrazzjoni tal-konjugi sulfatizzati ta' hydroxy aripiprazole fil-bile tal-bniedem fl-ogħla doża proposta, dik ta' 30 mg kuljum, ma kinitx iktar minn 6 % tal-konċentrazzjoni fil-bile li nstabet fix-xadini fl-istudju li dam 39 ġimgħa u hija ħafna inqas (6 %) mil-limiti ta' solubilità in vitro.
English: Tel: +420 225 775 111 office.cz@sandoz.com
Maltese: CZ-140 00 Praha 4 - Nusle Tel: +420 225 775 111 office.cz@sandoz.com
English: EU/1/15/1029/043 14 tablets EU/1/15/1029/044 28 tablets EU/1/15/1029/045 49 tablets EU/1/15/1029/046 56 tablets EU/1/15/1029/047 98 tablets
Maltese: EU/1/15/1029/043 14-il pillola EU/1/15/1029/043 28 pillola EU/1/15/1029/043 49 pillola EU/1/15/1029/043 56 pillola EU/1/15/1029/043 98 pillola
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: 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 (1017 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 bi plaċebo li damet 30 ġimgħa li kienet tinvolvi 296 tifel/tifla 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: Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Maltese: Aripiprazole Sandoz hu indikat għall-kura ta' skizofrenija fl-adulti u fl-adolexxenti minn età ta' 15-il sena jew aktar.
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' stabbilizzazzjoni qabel randomizzazzjoni, aripiprazole wera superjorità fuq plaċebo fil-prevenzjoni ta' rikorrenza bipolari, primarjament fil prevenzjoni ta' rikorrenza f'manija iżda naqas li juri s-superjorità fuq plaċebo fil-prevenzjoni ta'rikorrenza f'depressjoni.
English: At therapeutic concentrations, aripiprazole and dehydroaripiprazole 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-proteini tad-demm, u jintrabtu laktar mal-albumina.
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: Keep this leaflet.
Maltese: Stat ta' tipjip
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 għall-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: Aripiprazole Sandoz30mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 9.0mm, debossed with “SZ” on one side and “449” on the other side.
Maltese: Aripiprazole Sandoz 30 mg pilloli, huma pilloli tondi, ta' lewn roża, bit-tikek, b'dijametru ta' bejn wieħed u ieħor 9.0 mm, imnaqqxa b'“SZ” fuq naħa waħda u “449” fuq in-naħa l-oħra.
English: Tics associated with Tourette's disorder: the safety and efficacy of Aripiprazole Sandoz 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 Sandoz fit-tfal u adolexxenti bejn 6 snin u 18-il sena ma ġewx determinati s'issa.
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: Indigo Carmine (E132) Aluminium lake
Maltese: hydroxypropyl cellulose, magnesium stearate, indigo carmine (E132) aluminium lake.
English: How to take Aripiprazole Sandoz
Maltese: Tiħux Aripiprazole Sandoz
English: Each tablet contains 20 mg of aripiprazole.
Maltese: Kull pillola fiha 20 mg ta' aripiprazole.
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, li jinkludu aripiprazole, għandhom ikunu osservati għal sinjali u sintomi ta' ipergliċemija (bħal polydipsia, polyuria, polyphagia u debbulizza) u pazjenti bid-dijabete mellitus jew b'fatturi ta' riskju għal dijabete mellitus għandhom jiġu mmonitorjati regolarment għal aggravar fil-kontroll tal-glucose (ara sezzjoni 4.8).
English: Allergic reaction (e.g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria)
Maltese: Reazzjoni allerġika (eż. reazzjoni anafilattika, anġjoedima li tinkludi lsien minfuħ, edima tal-ilsien, edima tal-wiċċ, ħakk, jew urtikarja)
English: Excipient(s) with known effect 65.97 mg lactose monohydrate per tablet.
Maltese: 65.97 mg lactose monohydrate kull pillola.
English: Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg tablets For storage conditions after first opening of the bottle, see section 6.3.
Maltese: Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 30 mg pilloli Għall-kondizzjonijet ta' ħażna wara l-ewwel ftuħ tal-flixkun, ara sezzjoni 6.3.
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Aripiprazole Sandoz 20 mg
English: The efficacy of aripiprazole in paediatric subjects with Tourette's syndrome (aripiprazole: n=32, placebo: n=29) was also evaluated over a flexible dose range of 2 mg/day to 20 mg/day and a starting dose of 2 mg, in a 10 week, randomised, double blind, placebo-controlled study conducted in South-Korea.
Maltese: n = 29) kienet valutata fuq firxa ta' dożi flessibbli ta' 2 mg/jum sa 20 mg/jum u b'doża inizjali ta' 2 mg, fi studju każwali, double-blind, ikkontrollat bi plaċebo li dam sejjer 10 ġimgħat filKorea t'Isfel.
English: Aripiprazole Sandoz tablets contain lactose.
Maltese: Il-pilloli Aripiprazole Sandoz fihom il-lactose.
English: In clinical trials and post-marketing experience, accidental or intentional acute overdose of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg with no fatalities.
Maltese: Fi provi kliniċi u esperjenza ta' wara l-bejgħ, ġew identifikati każijiet gravi aċċidentali jew intenzjonati ta' doża eċċessiva ta' aripiprazole waħdu f'pazjenti adulti bid-dożi rrapportati kkalkulati sa 1,260 mg mingħajr ebda fatalità.
English: Each tablet contains 30 mg of aripiprazole.
Maltese: Kull pillola fiha 30 mg ta' aripiprazole.
English: Aripiprazole Sandoz 5 mg tablets are blue coloured, mottled, round shaped tablets, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side.
Maltese: Aripiprazole Sandoz 5 mg pilloli, huma pilloli tondi, ta' lewn blu, bit-tikek, b'dijametru ta' bejn wieħed u ieħor 6.0 mm, imnaqqxa b'“SZ” fuq naħa waħda u “444” fuq in-naħa l-oħra.
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: Excipient(s) with known effect 97.75 mg lactose monohydrate per tablet.
Maltese: 97.75 mg lactose monohydrate kull pillola.
English: Each tablet contains 10 mg of aripiprazole.
Maltese: Kull pillola fiha 10 mg ta' aripiprazole.
English: Each tablet contains 15 mg of aripiprazole.
Maltese: Kull pillola fiha 15 mg ta' aripiprazole.
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 sinifikanti fit-testijiet tal-laboratorju u f'parametri lipidi (ara sezzjoni 5.1) ma dehret l-ebda differenza medikament importanti.
English: In paediatric clinical trials of aripiprazole akathisia and Parkinsonism were observed.
Maltese: Fi provi kliniċi pedjatriċi ta' aripiprazole, ġew osservati akatisja u parkinsoniżmu.
English: A single-dose study in subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, and C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole and dehydroaripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which is insufficient to draw conclusions on their metabolic capacity.
Maltese: Studji ta' pazjenti b'mard tal-fwied (Child-Pugh Klassi A, B u C) li ngħataw doża waħda ma wrew lebda effett tal-mard tal-fwied fuq il-farmakokinetiċi ta' aripiprazole u dehydro-aripiprazole iżda listudju li inkluda 3 pazjenti biss b'ċirrożi tal-fwied Klassi C, huwa insuffiċjenti biex joħroġ b'konklużjonijiet fuq il-kapaċitajiet metaboliċi tagħhom.
English: Pink coloured, mottled, round shaped tablet, with an approximate diameter of 9.0 mm, debossed with “SZ” on one side and “449” on the other side.
Maltese: Pillola tonda, bit-tikek, ta' lewn roża, b'dijametru ta' bejn wieħed u ieħor 9.0 mm, imnaqqxa b'“SZ” fuq naħa waħda u “449” fuq in-naħa l-oħra.
English: Aripiprazole Sandoz20mg tablets are white coloured, round shaped tablets, with an approximate diameter of 7.8mm, debossed with “SZ” on one side and “448” on the other side.
Maltese: Aripiprazole Sandoz 20 mg pilloli, huma pilloli tondi, ta' lewn abjad, bit-tikek, b'dijametru ta' bejn wieħed u ieħor 7.8 mm, imnaqqxa b'“SZ” fuq naħa waħda u “448” fuq in-naħa l-oħra.
English: Aripiprazole group showed animprovement of 14.97 on TTS-YGTSS change from baseline to week 10 as compared with an improvement of 9.62 in the placebo group.
Maltese: Il-grupp ta' aripiprazole wera titjib ta' 14.97 fuq il-bidla TTS-YGTSS mil-linja bażi sa ġimgħa 10 meta mqabbel ma' titjib ta' 9.62 fil-grupp tal-plaċebo.
English: SK-811 02 Bratislava Tel: + 421 2 48 200 600 info@sandoz.sk
Maltese: Tel: + 421 2 48 200 600 info@sandoz.sk
English: Thus, aripiprazole is unlikely to cause clinically important medicinal product interactions mediated by these enzymes.
Maltese: Għaldaqstant mhuwiex probabbli li aripiprazole jikkawża interazzjonijiet klinikament sinifikanti relatati ma' prodotti mediċinali medjati minn dawn l-enzimi.
English: Each tablet contains 5 mg of aripiprazole.
Maltese: Kull pillola fiha 5 mg ta' aripiprazole.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/042
Maltese: EU/1/15/1029/042
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028
Maltese: EU/1/15/1029/028
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-iskizofrenja, ikkontrollat bl-olanzapine, li inkluda 314-il pazjent adult u fejn l-end-point primarju kien iż-żieda fil-piż, ferm inqas pazjenti kellhom mill-inqas żieda ta' 7 % fil-piż fuq il-linja bażi (jiġifieri żieda ta' mill-inqas 5.6 kg għall-punt medjan tal-linja bażi tal-piż ~80.
English: Excipient(s) with known effect 71.02 mg lactose monohydrate per tablet.
Maltese: 71.02 mg lactose monohydrate kull pillola.
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: Meta aripiprazole jin għata ma' sustanzi oħrajn li jistimulaw is-CYP3A4 b'mod qawwi (bħal rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine u ipericum (St.
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 bi plaċebo, li kienet tinvolvi 302 pazjenti adolexxenti skizofreniċi (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 Sandoz15mg tablets are yellow coloured, mottled, round shaped tablets, with an approximate diameter of 7.0mm, debossed with “SZ” on one side and “447” on the other side.
Maltese: Aripiprazole Sandoz 15 mg pilloli, huma pilloli tondi, ta' lewn isfar, bit-tikek, b'dijametru ta' bejn wieħed u ieħor 7.0 mm, imnaqqxa b'“SZ” fuq naħa waħda u “447” fuq in-naħa l-oħra.
English: Aripiprazole Sandoz 10 mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 6.0mm, debossed with “SZ” on one side and “446” on the other side.
Maltese: Aripiprazole Sandoz 10 mg pilloli, huma pilloli tondi, ta' lewn roża, bit-tikek, b'dijametru ta' bejn wieħed u ieħor 6.0 mm, imnaqqxa b'“SZ” fuq naħa waħda u “446” fuq in-naħa l-oħra.
English: To allow the start of the treatment at a low dose you can use an alternative formulation (oral solution - liquid) more suitable than Aripiprazole Sandoz tablets.
Maltese: Biex tippermetti l-bidu tal-kura b'doża baxxa, tista' tuża formolazzjoni alternattiva (soluzzjoni oralilikwida) aktar adattata minn Aripiprazole Sandoz pilloli.
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: 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 aġġuntiva wera superjorità fuq il-plaċebo fuq ilkejl tar-riżultat sekondarju, il-punteġġ tas-Severità tal-Marda CGI-BP (manija).
English: The safety profile of a long-term, double-blind placebo controlled trial was also similar except for the following reactions that were reported more frequently than paediatric patients taking placebo: weight decreased, blood insulin increased, arrhythmia, and leukopenia were reported commonly (≥ 1/100, < 1/10).
Maltese: Il-profil tas-sigurtà ta' prova double blind u bil-plaċebo bħala kontroll, fuq perijodu ta' żmien twil, kien simili wkoll għajr għar-reazzjonijiet li ġejjin li kienu rrapportati bi frekwenza aktar spissa milli f'pazjenti pedjatriċi li kienu qed jieħdu plaċebo: tnaqqis fil-piż, żieda fil-livell ta' insulina fid-demm, arritmija, u lewkopenija kienu rrapportati b'mod komuni (≥ 1/100, < 1/10).
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 Cmax ta' aripiprazole b'63% u 37 % rispettivament.
English: • thoughts of suicide, suicide attempt and suicide,
Maltese: • ħsibijiet ta' suwiċidju, tentattiv ta' suwiċidju, suwiċidju,
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.
English: Aripiprazole Sandoz 20 mg tablets
Maltese: Aripiprazole Sandoz 20 mg pilloli
English: Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n=99, placebo: n=44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weightbased treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Maltese: n = 44) fi studju każwali, double-blind, bil-plaċebo bħala kontroll, ta' 8 ġimgħat fejn intuża grupp ta' kura b'doża fissa abbażi tal-piż fuq firxa ta' dożi ta' bejn 5 mg/jum sa 20 mg/jum b'doża inizjali ta' 2 mg.
English: Manic episodes in Bipolar I Disorder: the recommended starting dose for Aripiprazole Sandoz 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 Sandoz 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: Serotonin syndrome Cases of serotonin syndrome have been reported in patients taking aripiprazole, and possible signs and symptoms for this condition can occur especially in cases of concomitant use with other serotonergic medicinal products, such as SSRI/SNRI, or with medicinal products that are known to increase aripiprazole concentrations (see section 4.8).
Maltese: Każijiet ta' sindromu ta' serotonin ġew irrappurtati f'pazjenti li kienu qed jieħdu aripiprazole u sinjali u sintomi possibbli għal din il-kundizzjoni jistgħu jseħħu speċjalment f'każijiet ta' użu fl-istess ħin ma' prodotti mediċinali serotonerġiċi oħrajn, bħal SSRI/SNRI, jew ma' prodotti mediċinali li huma magħrufin li jżidu l-konċentrazzjonijiet ta' aripiprazole (ara sezzjoni 4.8).
English: Aripiprazole Sandoz 30mg tablets
Maltese: Aripiprazole Sandoz 30mg pilloli
English: The 20 mg tablets are supplied in Aluminium//Aluminium blisters packed in cartons containing 14, 28, 49, 56 or 98 tablets.
Maltese: Il-pilloli ta' 20 mg jiġu f'folji tal-Aluminju /Aluminju ppakkjati f'kartun li jkun fihom 14, 28, 49, 56 jew 98 pillola.
English: • triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder,
Maltese: • triptans, tramadol u tryptophan użati għal kundizzjonijiet li jinkludu depressjoni, disturb ta'