FrancophonIA/ELRC3.0 huggingface dataset:
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 dehydro-aripiprazole, 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: At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99 % bound to serum proteins, binding primarily to albumin.
Maltese: aripiprazole u dehydro-aripiprazole jintrabtu b'iktar minn 99 % mal-protejini tad-demm, u jintrabtu laktar ma' l-albumina.
English: ABILIFY 5 mg tablets aripiprazole
Maltese: ABILIFY 5 mg pilloli aripiprazole
English: Suicide attempt, suicidal ideation and completed suicide (see section 4.4)
Maltese: Attentat ta' suwiċidju, formazzjoni ta' ħsieb biex jitwettaq suwiċidju, u t-twettiq ta' suwiċidju (ara sezzjoni 4.4)
English: ABILIFY 15 mg orodispersible tablets 15 mg: Round and yellow, marked with "A" over "641" on one side and "15" on the other.
Maltese: ABILIFY 15 mg pilloli li jinħallu fil-ħalq Tondi u isfar, immarkata b' "A" fuq "641" fuq naħa u “15” fuq in-naħa l-oħra.
English: Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain
Maltese: Disturb fir-regolazzjoni tat temperatura (eż ipotermja, deni) Uġigħ fis-sider
English: Tardive dyskinesia Dystonia
Maltese: Diskajneżja tardiva
English: Manic episodes in Bipolar I Disorder with oral aripiprazole In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
Maltese: Episodji manijaċi f'Disturb Bipolari I b'aripiprazole orali F'żewġ provi ta' monoterapija kkontrollata bi plaċebo, b'doża flessibbli ta' 3 ġimgħat li nvolvew pazjenti b'episodju manijaku jew imħallat ta' Disturb Bipolari I, aripiprazole wera effikaċja superjuri għal plaċebo fit-tnaqqis ta' sintomi manijaċi fuq 3 ġimgħat.
English: ABILIFY 10 mg orodispersible tablets are round and pink, marked with ‘"A" over "640"' on one side and ‘10' on the other.
Maltese: ABILIFY 10 mg pilloli li jinħallu fil-ħalq huma tondi u ta' kulur roża bil-marka ‘"A" fuq "640"' fuq naħa u ‘10' fuq in-naħa l-oħra.
English: Excipient with known effect 62.18 mg lactose (as monohydrate) per tablet
Maltese: 62.18 mg lactose (bħala monohydrate) kull pillola ABILIFY 15 mg pilloli
English: Manic episodes in Bipolar I Disorder: the recommended starting dose for ABILIFY is 15 mg (i.e. 15 mL solution/day) 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 ABILIFY hija 15 mg (i.e 15 mL soluzzjoni/jum) 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: At equivalent doses, the peak plasma concentrations of aripiprazole (Cmax) from the solution were somewhat higher but the systemic exposure (AUC) was equivalent to tablets.
Maltese: F'dożi ekwivalenti, il-konċentrazzjonijiet fil-plasma ta' aripiprazole (Cmax) mis-soluzzjoni kienu kemm xejn ogħla imma lespożizzjoni sistematika (AUC) kienet ekwivalenti għall-pilloli.
English: ABILIFY 15 mg tablets aripiprazole
Maltese: ABILIFY 15 mg pilloli aripiprazole
English: EU/1/04/276/006 (10 mg, 14 × 1 tablets) EU/1/04/276/007 (10 mg, 28 × 1 tablets) EU/1/04/276/008 (10 mg, 49 × 1 tablets) EU/1/04/276/009 (10 mg, 56 × 1 tablets) EU/1/04/276/010 (10 mg, 98 × 1 tablets)
Maltese: EU/1/04/276/006 (10 mg, 14 × 1 pilloli) EU/1/04/276/007 (10 mg, 28 × 1 pilloli) EU/1/04/276/008 (10 mg, 49 × 1 pilloli) EU/1/04/276/009 (10 mg, 56 × 1 pilloli) EU/1/04/276/010 (10 mg, 98 × 1 pilloli)
English: In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
Maltese: Fi provi kliniċi, ġew irrappurtati xi każijiet rari ta' konvulżjoni waqt it-trattament b'aripiprazole.
English: EU/1/04/276/011 (15 mg, 14 × 1 tablets) EU/1/04/276/012 (15 mg, 28 × 1 tablets) EU/1/04/276/013 (15 mg, 49 × 1 tablets) EU/1/04/276/014 (15 mg, 56 × 1 tablets) EU/1/04/276/015 (15 mg, 98 × 1 tablets)
Maltese: EU/1/04/276/011 (15 mg, 14 × 1 pilloli) EU/1/04/276/012 (15 mg, 28 × 1 pilloli) EU/1/04/276/013 (15 mg, 49 × 1 pilloli) EU/1/04/276/014 (15 mg, 56 × 1 pilloli) EU/1/04/276/015 (15 mg, 98 × 1 pilloli)
English: In the paediatric bipolar population (10 to 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 sa 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: 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 to 17 years), who met DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders) for Bipolar I Disorder with manic or mixed episodes with or without psychotic features and had a YMRS 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 sa 17-il sena) li kienu ssodisfaw il-kriterji tad-DSM-IV (Manwal Dijanjostiku u
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: Over 75 % of patients were less than 13 years of age.
Maltese: Aktar minn 75 % tal-pazjenti kellhom inqas minn 13-il sena.
English: Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69 % and 71 % lower, respectively, than those following treatment with aripiprazole alone.
Maltese: Hekk ukoll, għad-dehydro-aripiprazole, il-medji ġeometriċi tas-Cmax u l-AUC wara l-għoti ta' carbamazepine kienu ta' 69 % u 71 % inqas, rispettivament, minn dawk ta' wara l-kura b'aripiprazole orali waħdu.
English: NMS is a potentially fatal symptom complex associated with antipsychotics.
Maltese: NMS huwa grupp ta' sintomi li jista' jwassal għall-mewt,,assoċjat ma' antipsikotiċi.
English: Drug withdrawal syndrome neonatal (see section 4.6)
Maltese: Sindromu fit-trabi ta' waqfien ta' mediċini jew drogi li jivvizzjaw (ara sezzjoni 4.6)
English: Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji ta' l-aluminju perforati għal unità ta' doża f'kartun ta' 14 × 1, 28 × 1, 49 × 1 pillola.
English: • accidental inhalation of food with risk of pneumonia (lung infection),
Maltese: • bligħ aċċidentali ta' ikel b'riskju ta' pnewmonja (infezzjoni tal-pulmun),
English: • increased blood levels of the hormone prolactin,
Maltese: • żieda fil-livelli tal-ormon prolaktin fid-demm,
English: ABILIFY in one or more subsets of the paediatric population in the treatment of schizophrenia and in the treatment of bipolar affective disorder (see section 4.2 for information on paediatric use).
Maltese: ABILIFY f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fil-kura ta' skiżofrenja u fit-trattament ta' disturb affettiv bipolari (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: A vial contains 9.75 mg (1.3 mL) aripiprazole.
Maltese: Iddoża rakkomandata hija ta' 9.75 mg (1.3 mL) għall-ewwel injezzjoni.
English: In two long-term trials with adolescent (13 to 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 sa 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: 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' idroxi aripiprazole fil-bile talbniedem fl-ogħla doża proposta, dik ta' 30 mg kuljum, ma kienux iktar minn 6 % tal-konċentrazzjoni fil-bile li nstabet fix-xadini fl-istudju li dam 39 ġimgħa u huwa ħafna inqas (6 %) mill-limiti li taħthom jinħallu in vitro.
English: In subpopulation analyses on patients with mixed episodes or on patients with severe agitation, a similar pattern of efficacy to the overall population was observed but statistical significance could not be established due to a reduced sample size.
Maltese: F'analiżi ta' subpopolazzjoni fuq pazjenti b'episodji mħallta jew fuq pazjenti b'aġitazzjoni severa, ġiet osservata tendenza simili ta' effikaċja għall-popolazzjoni ġenerali iżda s-sinifikat statistiku ma setax jiġi stabbilit minħabba daqs imnaqqas tal-kampjun.
English: 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 selective serotonin reuptake inhibitor/selective serotonin noradrenalin reuptake inhibitor (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' mediċini serotonerġiċi oħrajn, bħal inibituri selettivi tat-teħid mill-ġdid ta' serotonin/inibituri selettivi tat-teħid mill-ġdid ta' serotonin-noradrenalin (SSRI/SNRI), jew ma' mediċini li huma magħrufa li jżidu l-konċentrazzjonijiet ta' aripiprazole (ara sezzjoni 4.8).
English: Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41 % and AUC by about 51 %, suggesting that charcoal may be effective in the treatment of overdose.
Maltese: Faħam attivat (50 g), li ngħata siegħa wara aripiprazole, naqqas is- Cmax ta' aripiprazole bejn wieħed u ieħor b' 41 % u l-AUC bejn wieħed u ieħor b' 51 %, li jissuġġerixxi li l-faħam jista jkun effettiv għallkura ta' doża eċċessiva.
English: Stiffness
Maltese: Konvulżjoni
English: aripiprazole and dehydro-aripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro.
Maltese: Ukoll, aripiprazole u dehydro-aripiprazole ma wrewx li jistgħu ibiddlu il metaboliżmu li jiġi effettwat mis-CYP1A2 fi studji in vitro.
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100 persuna):
English: Therefore, ABILIFY is not recommended for use in patients below 13 years of age (see sections 4.8 and 5.1).
Maltese: Għalhekk ABILIFY mhux rakkomandat għal użu f'pazjenti taħt it-13-il sena (ara sezzjonijiet 4.8 u 5.1).
English: ABILIFY 30 mg orodispersible tablets 30 mg: Round and pink, marked with "A" over "643" on one side and "30" on the other.
Maltese: ABILIFY 30 mg pilloli li jinħallu fil-ħalq Tondi u roża, immarkata b' "A" fuq "643" fuq naħa u “30” fuq in-naħa l-oħra.
English: Schizophrenia in adolescents aged 15 years and older In a short-term placebo-controlled clinical trial involving 302 adolescents (13 to 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: (minn 13 sa 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: Akathisia Extrapyramidal disorder Tremor
Maltese: Akatisja Disturb ekstrapiramidali
English: EU/1/04/276/001 (5 mg, 14 × 1 tablets) EU/1/04/276/002 (5 mg, 28 × 1 tablets) EU/1/04/276/003 (5 mg, 49 × 1 tablets) EU/1/04/276/004 (5 mg, 56 × 1 tablets) EU/1/04/276/005 (5 mg, 98 × 1 tablets)
Maltese: EU/1/04/276/001 (5 mg, 14 × 1 pilloli) EU/1/04/276/002 (5 mg, 28 × 1 pilloli) EU/1/04/276/003 (5 mg, 49 × 1 pilloli) EU/1/04/276/004 (5 mg, 56 × 1 pilloli) EU/1/04/276/005 (5 mg, 98 × 1 pilloli)
English: Pathological gambling and other impulse control disorders
Maltese: Logħob tal-ażżard u disturbi fil-kontroll tal-impuls
English: • slower heartbeat,
Maltese: • attakk tal-qalb,
English: The safety and efficacy of ABILIFY solution for injection in children and adolescents aged 0 to 17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' ABILIFY fi tfal u adolexxenti minn età ta' 0 sa 17-il sena ma ġewx determinati s'issa.
English: Elderly
Maltese: Ebusija
English: Use in children and adolescents The recommended dose for adolescents is 10 mL solution (corresponding to 10 mg aripiprazole)
Maltese: Id-doża rakkomandata għall-adolexxenti hija ta' 10 mg darba kuljum (li tikkorrespondi għal 10 mg aripiprazole) darba kuljum.
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0 %), extrapyramidal disorder (18.4 %), akathisia (16.0 %), and fatigue (11.8 %); and commonly (≥ 1/100, < 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia.
Maltese: (minn 13 sa 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: Neuroleptic Malignant Syndrome Grand mal convulsion Serotonin syndrome Speech disorder
Maltese: Sindromu tas-serotonin Disturb fid-diskors
English: The incidence of hypoprolactinaemia or decreased serum prolactin in patients treated with aripiprazole was 0.4 %, compared with 0.02 % for patients treated with placebo.
Maltese: L-inċidenza ta' ipoprolaktinemija jew tnaqqis ta' prolaktin fis-serum f'pazjenti trattati b'aripiprazole kien ta' 0.4 % meta mqabbel ma' 0.02 % għal pazjenti trattati bi plaċebo.
English: • involuntary loss of urine (incontinence),
Maltese: • telf involontarju ta' awrina,
English: Hepatobiliary
Maltese: Tromboċitopenija
English: Irritability associated with autistic disorder: the safety and efficacy of ABILIFY in children and adolescents aged below 18 years have not yet been established.
Maltese: Irritabilità marbuta ma' disturb awtistiku: is-sigurtà u effikaċja ta' ABILIFY fit-tfal u adolexxenti taħt l-età ta' 18-il sena ma ġewx determinati s'issa.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: • diabetes mellitus,
Maltese: • infjammazzjoni tal-frixa,
English: ABILIFY 10 mg orodispersible tablets 10 mg: Round and pink, marked with "A" over "640" on one side and "10" on the other.
Maltese: ABILIFY 10 mg pilloli li jinħallu fil-ħalq Tondi u roża, immarkata b' "A" fuq "640" fuq naħa u “10” fuq in-naħa l-oħra.
English: ABILIFY tablets are supplied in perforated unit dose blisters packed in cartons containing 14 × 1, 28 × 1, 49 × 1, 56 × 1, or 98 × 1 tablets.
Maltese: ABILIFY hu fornut f'folji ta' doża unika pperforati ppakkjati f'kartun li fihom 14 × 1, 28 × 1, 49 × 1,
English: In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107 %, while Cmax was unchanged.
Maltese: Quinidine u impedituri oħra ta' CYP2D6 Fi studju kliniku f'pazjenti b'saħħithom, impeditur qawwi tas-CYP2D6 (quinidine) żied l-AUC ta'
English: Patients with attention deficit hyperactivity disorder (ADHD) comorbidity Despite the high comorbidity frequency of Bipolar I Disorder and ADHD, very limited safety data are available on concomitant use of aripiprazole and stimulants; therefore, extreme caution should be taken when these medicinal products are co-administered.
Maltese: Minkejja l-frekwenza għolja ta' komorbidità għal Disturb Bipolari I u ADHD, hemm dejta limitata ħafna dwar l-użu fl-istess ħin ta' aripiprazole u stimulanti; għalhekk għandha tingħata attenzjoni kbira ħafna meta dawn il-mediċni jingħataw fl-istess ħin.
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' ‘creatine phosphokinase' u rabdomajoliżi, mhux neċessarjemant assoċjati ma' NMS.
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: 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'
English: Pathological gambling Impulse-control disorder Binge eating
Maltese: Disturb tal-kontroll tal-impuls
English: • stomach discomfort,
Maltese: • diffikultà biex tibla',
English: Package leaflet: Information for the user ABILIFY 10 mg orodispersible tablets ABILIFY 15 mg orodispersible tablets ABILIFY 30 mg orodispersible tablets aripiprazole
Maltese: Skiżofrenja: id-doża tal-bidu rakkomandata għal ABILIFY hija ta' 10 mg/jum jew 15 mg/jum b'doża ta' manteniment ta' 15 mg/jum mogħtija fuq skeda ta' waħda kull jum mingħajr attenzjoni lejn l-ikliet.
English: Hepatic impairment
Maltese: Aġitazzjoni Nervożità
English: Acesulfame potassium
Maltese: Kif taħżen ABILIFY
English: The overall completion rate was significantly higher for patients on aripiprazole (43 %) than for haloperidol (30 %).
Maltese: Ir-rata globali ta' dawk li spiċċaw il-kors kienet sinifikament ogħla għall pazjenti fuq aripiprazole (43 %) milli għall-haloperidol (30 %).
English: Each carton contains one bottle and both a calibrated polypropylene measuring cup and a calibrated polypropylene low-density polyethylene dropping pipette.
Maltese: Kull kartuna fiha flixkun wieħed kif ukoll tazza kkalibrata tal-polypropylene għall-kejl u pipetta għat tqattir ikkalibrata tal-polypropylene maghmula minn polyethylene b'densità baxxa.
English: Developmental toxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were observed in rats at doses resulting in subtherapeutic exposures (based on AUC) and in rabbits at doses resulting in exposures 3 and 11 times the mean steady-state AUC at the maximum recommended clinical dose.
Maltese: Effett tossiku fuq l-iżvilupp, li jinkludu, tardjar ta' l ossifikazzjoni tal-fetu skond id-doża u effetti teratoġeniċi possibli ġew osservati f'firien b'dożi li jirriżultaw f'espożizzjonijiet taħt il-livelli terapewtiċi (ibbażati fuq l-AUC) u fi fniek b'dożi li jirriżultaw f'espożizzjonijiet ta' 3 u 11-il darba iktar mill-medja ta' l-AUC fi stat stabbli fid-doża massima klinika rakkomandata.
English: 14 × 1 orodispersible tablets 28 × 1 orodispersible tablets 49 × 1 orodispersible tablets
Maltese: 14 × 1 pilloli li jinħallu fil-ħalq
English: Constipation Dyspepsia Nausea Salivary hypersecretion Vomiting
Maltese: Calcium silicate Croscarmellose sodium Crospovidone Silicon dioxide Xylitol
English: EU/1/04/276/030 (30 mg, 14 × 1 orodispersible tablets) EU/1/04/276/031 (30 mg, 28 × 1 orodispersible tablets) EU/1/04/276/032 (30 mg, 49 × 1 orodispersible tablets)
Maltese: EU/1/04/276/030 (30 mg, 14 × 1 pilloli li jinħallu fil-ħalq) EU/1/04/276/031 (30 mg, 28 × 1 pilloli li jinħallu fil-ħalq) EU/1/04/276/032 (30 mg, 49 × 1 pilloli li jinħallu fil-ħalq)
English: Manic episodes in Bipolar I Disorder: the recommended starting dose for ABILIFY 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 ABILIFY 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: • difficulty controlling core body temperature or overheating,
Maltese: • diffikultà fil-kontroll tat-temperatura tal-ġisem jew sħana eċċessiva,
English: Round and yellow, engraved with "A-009" and "15" on one side.
Maltese: ABILIFY 15 mg pilloli Tonda u safra, imnaqqxa b'“A-009” u “15” fuq naħa waħda.
English: IM use
Maltese: Prijapiżmu
English: Haemodialysis
Maltese: MEDIĊINALI
English: Each mL contains 1 mg of aripiprazole.
Maltese: Kull mL fih 1 mg ta' aripiprazole.
English: After a 13 to 26-week stabilisation on aripiprazole (2 mg/day to 15 mg/day) patients with a stable response were either maintained on aripiprazole or substituted to placebo for further 16 weeks.
Maltese: Wara stabbilizzazzjoni ta' 13 sa 26 ġimgħa fuq aripiprazole (2 mg/jum sa 15 mg/jum) pazjenti b'rispons stabbli kienu jew miżmuma fuq aripiprazole jew sostitwiti għal plaċebo għal 16-il ġimgħa addizzjonali.
English: Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older: the recommended dose for ABILIFY is 10 mg/day administered on a once-a-day schedule without regard to meals.
Maltese: Episodji manijaċi f'Disturb Bipolari I f'adolexxenti li għandhom 13-il sena jew aktar: id-doża rakkomandata għal ABILIFY hi ta' 10 mg/kuljum li tingħata fuq skeda ta' darba kuljum mingħajr ma jingħata kas tal-ikel.
English: Dose adjustments due to interactions
Maltese: Aktar tnixxija milli suppost ta'
English: • certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. indinavir, ritonavir)
Maltese: • ċerti mediċini biex jittrattaw infezzjoni ta' HIV (bħal efavirenz, nevirapine, u impedituri ta'
English: Extrapyramidal symptoms were mainly reported during the stabilisation phase in 17 % of patients, with tremor accounting for 6.5 %.
Maltese: Sintomi ekstrapiramidali ġew irrappurtati primarjament matul il-fażi ta' stabbilizzazzjoni fi 17 % tal-pazjenti, bir-rogħda li kienet tammonta għal 6.5 %.