qanastek/EMEA-V3 huggingface dataset:
Cardiac disorders Uncommon: tachycardia* Nervous System disorders Common: extrapyramidal disorder, akathisia, tremor, dizziness, somnolence, sedation, headache Eye disorders Common: blurred vision Gastrointestinal disorders Common: dyspepsia, vomiting, nausea, constipation, salivary hypersecretion Vascular disorders Uncommon: orthostatic hypotension* General disorders and administration site conditions Common: fatigue Psychiatric disorders Common: restlessness, insomnia, anxiety Uncommon: depression*
30 Disturbi kardijaċi Mhux komuni: takikardija * Disturbi fis- sistema nervuża Komuni: disturbi ekstrapiramidjali, akatisja, rogħda, sturdament, ħedla ta ’ rqad, sedazzjoni, uġigħ ta ’ ras Disturbi fl- għajnejn Komuni: vista bi żlieġa Disturbi gastro- intestinali Komuni: dispepsja, remettar, nawsja, stitikezza, sekrezzjoni eċċessiva tal- bżieq Disturbi vaskulari Mhux komuni: pressjoni ortostatika baxxa ħafna * Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni: għejja Disturbi psikjatriċi Komuni: irrekwitezza, insomnja, ansjetà Mhux komuni: depressjoni *
28 Extrapyramidal symptoms (EPS):
Sintomi ekstrapiramidali (EPS):
Schizophrenia - in a long term 52-week controlled trial, aripiprazole-treated patients had an overall-lower incidence (25.8%) of EPS including parkinsonism, akathisia, dystonia and dyskinesia compared with those treated with haloperidol (57.3%).
Skizofrenija - 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%).
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.
Fi studju fit- tul ta ’ 26 ġimgħa kkontrollat minn plaċebo, l- inċidenza ta ’ EPS kienet 19% għall- pazjenti ikkurati b’ aripiprazole u 13. 1% għall- pazjenti ikkurati bil- plaċebo.
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.
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.
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.
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.
In another 12-week trial, the incidence of EPS was 26.6% for patients treated with aripiprazole and 17.6% for those treated with lithium.
Fi prova oħra ta ’ 12- il ġimgħa, l- inċidenza ta ’ EPS kienet ta ’ 26. 6% għal pazjenti ttrattati b’ aripiprazole u 17. 6% għal dawk ittrattati b’ litju.
In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of EPS was 18.2% for aripiprazole-treated patients and 15.7% for placebo-treated patients.
F’ fażi ta ’ manutenzjoni ta ’ 26 ġimgħa fuq perjodu ta ’ żmien twil ta ’ prova kkontrollata bi plaċebo, l- inċidenza ta ’ EPS kienet 18. 2% għal pazjenti ttrattati b’ aripiprazole u 15. 7% għal pazjenti ttrattati bi plaċebo.
In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo.
Fi provi kkontrollati bi plaċebo, l- inċidenza ta ’ akatisja f’ pazjenti bipolari kienet ta ’ 12. 1% b ’ aripiprazole u 3. 2% bi plaċebo.
In schizophrenia patients the incidence of akathisia was 6.2% with aripiprazole and 3.0% with placebo.
F’ pazjenti bi skizofrenija, l- inċidenza ta ’ akatisja kienet ta ’ 6. 2% b’ aripiprazole u 3. 0% bi plaċebo.
Comparisons between aripiprazole and placebo in the proportions of patients experiencing potentially clinically significant changes in routine laboratory parameters revealed no medically important differences.
Meta wieħed iqabbel aripiprazole mal- plaċebo fuq il- proporzjon tal- pazjenti li wrew tibdil klinikament importanti fit- testijiet tal- laboratorju, ma dehret l- ebda differenza importanti klinikament.
Elevations of CPK (Creatine Phosphokinase), generally transient and asymptomatic, were observed in 3.5% of aripiprazole treated patients as compared to 2.0% of patients who received placebo.
Elevazzjonijiet ta ’ CPK (Kreatina Fosfokinejż), ġeneralment li tgħaddi u asintomatika, kienu osservati f’ 3. 5% tal- pazjenti ikkurati b’ aripiprazole meta mqabbla ma ’ 2. 0% tal- pazjenti li rċevew plaċebo.
Other findings:
Riżultati oħrajn:
Undesirable effects known to be associated with antipsychotic therapy and also reported during treatment with aripiprazole include neuroleptic malignant syndrome, tardive dyskinesia, seizure, cerebrovascular adverse events and increased mortality in elderly demented patients, hyperglycaemia and diabetes mellitus (see section 4.4).
Effetti mhux mixtieqa magħrufa li jseħħu meta jingħataw antipsikotiċi u li ġew ukoll irrappurtati waqt it- trattament b’ aripiprazole jinkludu is- sindromu newrolettiku malinn, diskineżja li tiżviluppa fit- tard, attakk ta 'puplesija, ġrajjiet avversi ċerebrovaskulari u żjieda fir- rata ta' mwiet f' pazjenti anzjani b' dimensja, ipergliċemija u dijabete mellitus (ara taqsima 4. 4).
Post-Marketing:
Wara l- bejgħ:
The following adverse events have been reported during post-marketing surveillance.
Il- ġrajjiet avversi li ġejjin ukoll ġew irrapurtati waqt sorveljanza wara l- bejgħ.
The frequency of these events is considered not known (cannot be estimated from the available data).
Il- frekwenza ta ’ dawn l - episodji hija bbażata fuq stima ta ’ l- espożizzjoni tal- pazjent):
Investigations:
Investigazzjonijiet:
increased Creatine Phosphokinase, blood glucose increased, blood glucose fluctuation, glycosylated haemoglobin increased
żieda f’ Creatine Phosphokinase, żieda fil- glucose fid- demm, flutwazzjoni tal- glucose fid- demm, żieda fil- glycosylated haemoglobin
Cardiac disorders:
Disturbi fil- qalb:
QT prolongation, ventricular arrhythmias, sudden unexplained death, cardiac arrest, torsades de pointes, bradycardia
tkarkir ta 'QT, ventricular arrhythmias, mewt zopptu bla spjegazzjoni, attakk tal- qalb, torsades de pointes, bradycardia 31
Blood and the lymphatic system disorders:
Disturbi tad- demm u tas - sistema limfatika
leukopenia, neutropenia, thrombocytopenia
lewkopenja, newtropenja, tromboċitopenja
Nervous system disorders:
Disturbi fis- sistema nervuża:
speech disorder, Neuroleptic Malignant Syndrome (NMS), grand mal convulsion
disturbi fid- diskors, Sindromu Newrolettiku Malinn (NMS), konvulżjoni grand mal
Respiratory, thoracic and mediastinal disorders:
Disturbi respiratorji, toraċiċi u medjastinali:
oropharyngeal spasm, laryngospasm, aspiration pneumonia
spażmu tal- faringi, spażmu tal- larinġi, pnewmonja tan- nifs
Gastrointestinal disorders:
Disturbi gastro- intestinali:
pancreatitis, dysphagia, abdominal discomfort, stomach discomfort, diarrhoea
pankreatite, disfaġja, diqa addominali, diqa fl- istonku, dijarea
Renal and urinary disorders:
Disturbi fil- kliewi u fis - sistema urinarja:
urinary incontinence, urinary retention
inkontinenza ta 'l- awrina, żamma ta' l- awrina
rash, photosensitivity reaction, alopecia, hyperhidrosis
raxx, reazzjoni fotosensittivà, alopeċja, iperidrożi
Musculoskeletal and connective tissue disorders:
Disturbi muskolu- skeltrali u tal- connective tissue u ta 'l - għadam:
rhabdomyolysis, myalgia, stiffness
rhabdomyolysis, uġigħ fil- muskoli, ebusija
Endocrine disorders:
Disturbi fis- sistema endokrinarja:
hyperglycaemia, diabetes mellitus, diabetic ketoacidosis, diabetic hyperosmolar coma
ipergliċemija, dijabete mellitus, ketoacidosi dijabetika, koma ipersmolari tad- dijabete
Metabolism and nutrition disorders:
Disturbi fil- metaboliżmu u n - nutrizzjoni:
weight gain, weight decreased, anorexia, hyponatremia
żjieda fil- piż, tnaqqis fil- piż, anoressja, hyponatremia
Vascular disorders:
Disturbi vaskulari:
syncope, hypertension, thromboembolic events
sinkope, pressjoni għolja, episodji tromo- emboliċi
General disorders and administration site conditions:
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata:
temperature regulation disorder (e. g. hypothermia, pyrexia), chest pain, peripheral oedema
diżordni fir- regolament tat- temperatura (eż. ipotermija, deni), uġigħ fis- sider, edima periferali
Immune system disorders:
Disturbi fis- sistema immuni
allergic reaction (e. g. anaphylactic reaction, angioedema including swollen tongue, tongue oedema, face oedema, pruritus, or urticaria)
reazzjoni allerġika (eż. reazzjoni anafilattika, anġjoedima inkluż in - nefħa ta 'l- ilsien, edima ta' l- ilsien, edima tal- wiċċ, ħakk tal- ġilda, jew urtikarja)
Hepatobiliary disorders:
Disturbi fil- fwied u fil - marrara:
jaundice, hepatitis, increased Alanine Aminotransferase (ALT), increased Aspartate Aminotransferase (AST), increased Gamma Glutamyl Transferase (GGT), increased alkaline phosphatase
suffejra, epatite, żieda fl- Alanine Aminotransferase (ALT), żieda fl - Aspartate Aminotransferase (AST), żieda fil- Gamma Glutamyl Transferase (GGT), żieda fl- alkaline phosphatase
Reproductive system and breast disorders:
Disturbi fis- sistema riproduttiva u fis- sider:
priapism
priapiżmu
Psychiatric disorders:
Disturbi psikjatriċi:
agitation, nervousness; suicide attempt, suicidal ideation, and completed suicide (see section 4.4)
aġitazzjoni, nervożiżmu; tentattivi ta ’ suwiċidju, ideazzjoni ta ’ suwiċidju u twettiq ta ’ suwiċidju (ara sezzjoni 4. 4)
In clinical trials and post-marketing experience, accidental or intentional acute overdosage of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg with no fatalities.
Fi provi kliniċi u esperjenza ta 'wara l- bejgħ, kienu identifikati każi gravi aċċidentali jew intenzjonati ta' doża eċċessiva ta 'aripiprazole waħdu f' pazjenti adulti bid- dożi rrapurtati kkalkulati sa 1, 260 mg mingħajr ebda fatalità.
The potentially medically important signs and symptoms observed included lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea.
Is- sinjali u sintomi osservati li possibbilment huma medikament importanti jinkludu letarġija, żjieda fil- pressjoni tad- demm, ħedla ta 'rqad, tatikardija, nawsja, remettar u dijarea.
In addition, reports of accidental overdose with aripiprazole alone (up to 195 mg) in children have been received with no fatalities.
Barra minn hekk, kien hemm rapporti ta 'każijiet aċċidentali ta' doża eċċessiva ta 'aripiprazole waħdu (sa 195 mg) fi tfal mingħajr ebda fatalità.
The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
32 medikament importanti kienu jinkludu ħedla ta 'rqad, telf temporanju ta' koxjenza u sintomi ekstrapiramidali.
Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
Meta wieħed jieħu doża eċċessiva, it- trattament għandu jkun l- iżjed terapija ta ’ sapport, billi żżomm il- pajp tan- nifs miftuħ, biżżejjed ossiġnu fid- demm u ventilazzjoni tajba, u trattament tas- sintomi.
The possibility of multiple medicinal product involvement should be considered.
Il - possibilità ta ’ involviment ta ’ doża multipla għandha tiġi kunsidrata.
Therefore cardiovascular monitoring should be started immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Għalhekk osservazzjoni kardjovaskolari għandha tibda immedjatament u għandha tinkludi osservazzjoni kontinwa elektrokardjografika biex taqbad xi possibiltà ta ’ arrhythmia.
Following any confirmed or suspected overdose with aripiprazole, close medical supervision and monitoring should continue until the patient recovers.
Jekk wieħed jissuspetta jew jikkonferma li ttieħdet doża eċċessiva t ’ aripiprazole, il- pazjent għandu jiġi segwit mill- qrib mit- tobba sakemm il - pazjent jirkupra.
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.
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 għall - kura ta ’ doża eċċessiva.
Although there is no information on the effect of haemodialysis in treating an overdose with aripiprazole, haemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.
Għalkemm m’ hemm l- ebda tagħrif fuq kif l- emodijaliżi jaħdem fit- trattament ta ’ doża eċċessiva ta ’ aripirazole, l- emodijaliżi x’ aktarx m’ huwiex utli f’ każijiet bħal dawn minħabba li aripiprazole huwa marbut b’ mod qawwi mal- proteini tal- plasma.
Pharmacotherapeutic group: antipsychotics, ATC code:
Kategorija farmakoterapewtika: antipsikotiċi, Kodiċi ATC:
30 It has been proposed that aripiprazole’ s efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
Ġie propost li l- effikaċja ta 'l- aripiprazole fuq is- skizofrenja u Disturb Bipolari I hija medjatur bejn taħlita ta' agoniżmu parzjali tar- reċetturi dopamina D2 u serotonina 5HT1a, u antagoniżmu tar - reċetturi serotonina 5HT2.
Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic hypoactivity.
Aripiprazole wriet li tnaqqas l- attività f’ annimali li juru attività żejda tad - dopamina u żżid l- attività f’ annimali li juru nuqqas ta ’ attività tad- dopamina.
Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors.
L- aripiprazole wera affinità ta 'rabta qawwija in vitro għar- reċetturi tad- dopamina D2 u D3, tas- serotonina 5HT1a u 5HT21, u b’ mod inqas qawwi mar- reċetturi tad- dopamina D4, tas- serotonina 5HT2c u 5HT7, α1 - adrenerġiki u H1 istamina.
Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for muscarinic receptors.
Aripiprazole ukoll torbot b’ saħħa moderata mal- postijiet fejn terġa ’ tinġabar is- serotonina, torbot ftit li xejn mar- reċetturi muskariniċi.
Interaction with receptors other than dopamine and serotonin subtypes may explain some of the other clinical effects of aripiprazole.
L- effetti kliniċi oħrajn ta ’ aripiprazole jistgħu ikunu minħabba li aripiprazole taħdem ukoll fuq reċetturi oħrajn barra dawk tad- dopamina u tat- tipi differenti tas- serotonina.
Aripiprazole doses ranging from 0.5 to 30 mg administered once a day to healthy subjects for 2 weeks produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/ D3 receptor ligand, to the caudate and putamen detected by positron emission tomography.
Dożi ta 'aripiprazole li jvarjaw minn 0. 5 sa 30 mg mogħtija darba kuljum għal ġimgħatejn lil nies b' saħħithom ipproduċew tnaqqis ta' dipendanza fuq id- droga fl- irbit ta ’ 11C- raclopride, reċettur li jgħaqqad D2/ D3, caudate u l- putamen osservati bit- tomografija bl- emisssjoni positronika.
Further information on clinical trials:
Iżjed tagħrif fuq studji kliniċi:
Schizophrenia:
Skizofrenja:
In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic patients, presenting with positive or negative symptoms, aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Fi tliet provi kliniċi fuq medda qasira (4 sa 6 ġimgħat) ikkontrollati minn plaċebo li fihom kienu involuti 1, 228 pazjent skiżofreniku li wrew sintomi pożittivi jew negattivi, l- aripiprazole orali kien assoċjat ma ’ titjib statistikament sinifikanti akbar fis- sintomi psikotiċi meta mqabbla mal- plaċebo.
ABILIFY is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
ABILIFY huwa effettiv li jżomm titjib kliniku waqt kura kontinwa f’ pazjenti li wrew rispons fil- bidu tal- kura.
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%).
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%).
The overall completion rate was significantly higher for patients on aripiprazole (43%) than for haloperidol (30%).
Ir- rata globali ta ’ dawk li spiċċaw il- kors kienet sinifikament ogħla għall- pazjenti fuq aripiprazole (43%) milli għall- haloperidol (30%).
Actual scores in rating scales used as secondary endpoints, including PANSS and the Montgomery-Asberg Depression Rating Scale showed a significant improvement over haloperidol.
Il- punteġġ attwali fl- iskali tal- klassifika użati bħala endpoints sekondarji, li jinkludu PANSS u il- Montgomery- Asberg Depression Rating Scale urew titjib sinifikanti fuq haloperidol.
In a 26-week, placebo-controlled trial in stabilised patients with chronic schizophrenia, aripiprazole had significantly greater reduction in relapse rate, 34% in aripiprazole group and 57% in placebo.
Fi provi ta ’ 26 ġimgħa kkontrollati bil- plaċebo f ’ pazjenti stabbilizzati, bi skizofrenja kronika, l - aripiprazole orali kellu tnaqqis sinifikament akbar fir- rata ta 'pazjenti li rkadew, 34% fil- grupp ta ’ aripiprazole orali u 57% fil- plaċebo.
Weight gain: in clinical trials aripiprazole has not been shown to induce clinically relevant weight gain.
33 Żieda fil- piż: fi provi kliniċi l- aripiprazole orali ma deherx li jwassal għal żieda fil- piż li hija klinikament relevanti.
In a 26-week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 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).
(i. e. żieda ta ’ mill - inqas ta ’ 5. 6 kg għall- punt 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).
Manic episodes in Bipolar I Disorder:
Episodji manijaċi f’ Disturbi Bipolari I:
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.
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 akbar minn plaċebo fit- tnaqqis ta ’ sintomi manijaċi fuq 3 ġimgħat.
These trials included patients with or without psychotic features and with or without a rapid-cycling course.
Dawn il- provi inkludew pazjenti bi jew mingħajr karatteristiċi psikotiċi u bi jew mingħajr kors ta ’ ċiklu rapidu.
In one 3-week, fixed-dose, placebo-controlled monotherapy trial involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole failed to demonstrate superior efficacy to placebo.
Fi prova ta ’ monoterapija kkontrollata bi plaċebo, b’ doża fissa ta ’ 3 ġimgħat li nvolviet pazjenti b’ episodju manijaku jew imħallat ta ’ Disturb Bipolari I, aripiprazole naqas li juri effikaċja superjuri għal plaċebo.
In two 12-week, placebo- and active-controlled monotherapy trials in patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, aripiprazole demonstrated superior efficacy to placebo at week 3 and a maintenance of effect comparable to lithium or haloperidol at week 12.
F’ żewġ provi ta ’ monoterapija kkontrollata bi plaċebo u attiva ta ’ 12- il ġimgħa f’ pazjenti b’ episodju manijaku jew imħallat ta ’ Disturb Bipolari I, bi jew mingħajr karatteristiċi psikotiċi, aripiprazole wera effikaċja superjuri għal plaċebo f’ ġimgħa 3 u manteniment ta ’ effett komparabbli għal litju jew haloperidol f’ ġimgħa 12.
Aripiprazole also demonstrated a comparable proportion of patients in symptomatic remission from mania as lithium or haloperidol at week 12.
Aripiprazole wera wkoll proporzjon komparabbli ta ’ pazjenti b’ remissjoni sintomatika minn manija bħal litju jew haloperidol f’ ġimgħa 12.
In a 6-week, placebo-controlled trial involving patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, who were partially non-responsive to lithium or valproate monotherapy for 2 weeks at therapeutic serum levels, the addition of aripiprazole as adjunctive therapy resulted in superior efficacy in reduction of manic symptoms than lithium or valproate monotherapy.
Fi prova kkontrollata bi plaċebo ta ’ 6 ġimgħat li tinvolvi pazjenti b’ episodju manijaku jew imħallat ta ’ Disturb Bipolari I, bi jew mingħajr karatteristiċi psikotiċi, li kienu pazjalment mhux risponsivi għal monoterapija b’ litju jew valproate għal ġimagħtejn f’ livelli ta ’ serum terapewtiċi, iż- żieda ta ’ aripiprazole bħala terapija aġġuntiva rriżultat f’ effikaċja superjuri fit- tnaqqis ta ’ sintomi manijaċi minn monoterapija b’ litju jew valproate.
31 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 randomization, 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.
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 fil - prevenzjoni ta ’ rikorrenza f’ manija iżda naqas li juri s- superjorità fuq plaċebo fil- prevenzjoni ta ’ rikorrenza f’ depressjoni.
Absorption:
Assorbiment:
Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3-5 hours after dosing.
Aripiprazole jiġi assorbit b' mod tajjeb, bl- ogħla konċentrazzjonijiet fil- plasma jintlaħqu fi żmien 3- 5 sigħat wara li tittieħed id- doża.
Aripiprazole undergoes minimal pre-systemic metabolism.
Aripiprazole ikollu metaboliżmu pre- sistematiku minimu.
The absolute oral bioavailability of the tablet formulation is 87%.
Il - bijodisponibbilità orali assoluta tal- formolazzjoni tal- pillola hija ta '87%.
There is no effect of a high fat meal on the pharmacokinetics of aripiprazole.
Ma hemmx effett fuq il - farmakokinetika ta 'aripiprazole b' ikla b' ħafna xaħam.
Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/ kg, indicating extensive extravascular distribution.
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.
At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99% bound to serum proteins, binding primarily to albumin.
F’ konċentrazzjonijiet terapewtiċi, aripiprazole u dehydro- aripiprazole jintrabtu b’ iktar minn 99% mal- protejini tad- demm, u jintrabtu l - aktar ma ’ l- albumina.
Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation.
Aripiprazole tiġi metabolizzata b’ mod qawwi mill- fwied bi tlett metodi ta ’ biotransformazzjoni: deidroġinazzjoni, idroksilazzjoni u N- di- alkajlazzjoni.
Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalysed by CYP3A4.
Milli nafu mill- istudji in vitro, l- enżimi CYP3A4 u CYP2D6 jagħmlu de- idroġinazzjoni u idroksilazzjoni ta ’ aripiprazole, u CYP2D6 jagħmel l - N- di- alkajlazzjoni.
Aripiprazole is the predominant medicinal product moiety in systemic circulation.
Aripiprazole hija l- iżjed forma tal- prodott li tinstab fiċ- ċirkolazzjoni tal - ġisem.
At steady state, dehydro-aripiprazole, the active metabolite, represents about 40% of aripiprazole AUC in plasma.
Fi stat stabbli, dehydro- aripiprazole, il- prodott tal- metaboliżmu attiv, jagħmel madwar 40% ta ’ l- AUC ta ’ aripiprazole fil- plasma.
Elimination:
34 Eliminazzjoni:
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.
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.
The total body clearance of aripiprazole is 0.7 ml/ min/ kg, which is primarily hepatic.
Ir- rata ta ’ l- eliminazzjoni sħiħa mill- ġisem ta ’ aripiprazole hija ta ’ 0. 7 ml/ min/ kg, li sseħħ l- aktar fil - fwied.
Following a single oral dose of [14C]-labelled aripiprazole, approximately 27% of the administered radioactivity was recovered in the urine and approximately 60% in the faeces.
Wara li ngħatat doża waħda mill- ħalq ta ’ aripiprazole mmarkata bl - [14C], bejn wieħed u ieħor 27% u 60% tar- radjoattività li ngħatat ħarġet fl- awrina u madwar 60% ma 'l- ippurgar.
Less than 1% of unchanged aripiprazole was excreted in the urine and approximately 18% was recovered unchanged in the faeces.
Inqas minn 1% ta ’ aripiprazole mhux imbiddel tneħħa fl- awrina u bejn wieħed u ieħor 18% inġabar mhux mibdul fl - ippurgar.
Pharmacokinetics in special patient groups
Farmakokinetiċi fi gruppi speċjali
There are no differences in the pharmacokinetics of aripiprazole between healthy elderly and younger adult subjects, nor is there any detectable effect of age in a population pharmacokinetic analysis in schizophrenic patients.
M’ hemm l- ebda differenza fil- farmakokinetiċi ta ’ aripiprazole bejn anzjani b’ saħħithom u pazjenti adulti, lanqas ma hemm effett li għandhu x’ jaqsam ma ’ l- età f’ analiżi farmakokinetika tal - popolazzjoni ta ’ pazjenti skizofreniċi.
There are no differences in the pharmacokinetics of aripiprazole between healthy male and female subjects nor is there any detectable effect of gender in a population pharmacokinetic analysis in schizophrenic patients.
M’ hemm l- ebda differenza fil- farmakokinetiċi ta ’ aripiprazole bejn rġiel u nisa b’ saħħithom, lanqas ma kien hemm effett li għandhu x’ jaqsam ma ’ sess fi studji farmakokinetiċi ta ’ popolazzjoni ta ’ pazjenti skiżofreniċi.
Smoking and Race:
Tipjip u Razza:
Population pharmacokinetic evaluation has revealed no evidence of clinically significant race-related differences or effects from smoking upon the pharmacokinetics of aripiprazole.
Studju farmakokinetiku tal- popolazzjoni ma wera l- ebda differenzi fuq skala klinikament importanti li għandhom x’ jaqsmu mar- razza jew mat- tipjip.
Renal Disease:
Mard tal- kliewi:
The pharmacokinetic characteristics of aripiprazole and dehydro-aripiprazole were found to be similar in patients with severe renal disease compared to young healthy subjects.
F’ pazjenti b’ mard tal- kliewi gravi, il- karatteristiċi farmakokinetiċi ta ’ aripiprazole u dehydro - aripiprazole instabu li huma simili ma ’ dawk f’ pazjenti żgħar f’ saħħithom.
32 Hepatic Disease:
Mard tal- fwied:
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.
Studji ta ’ pazjenti b’ mard tal- fwied (Child- Pugh Klassi A, B u C) li ngħataw doża waħda ma wrew l - ebda effett tal- mard tal- fwied fuq il- farmakokinetiċi ta ’ aripiprazole u dehydro- aripiprazole iżda l - istudju li inkluda 3 pazjenti biss b’ ċirrożi tal- fwied Klassi C, huwa insuffiċjenti biex joħroġ b’ konklużjonijiet fuq il- kapaċitajiet metaboliċi tagħhom.
Non-clinical safety data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta 'aripiprazole orali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin.
Toxicologically significant effects were observed only at doses or exposures that were sufficiently in excess of the maximum human dose or exposure, indicating that these effects were limited or of no relevance to clinical use.
Effetti ta ’ importanza tossikoloġika li ġew osservati biss b’ dożi jew espożizzjonijiet meqjusa ferm aktar ogħla mill- massimu tad- doża jew espożizzjoni fil- bnedmin, juru li dawn l- effetti ftit jew xejn għandhom relevanza waqt l- użu kliniku.
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).
Dawn jinkludu: tossiċita` adreno- kortikali li tiddependi fuq id- doża (ġbir ta ’ kulur lipofuscin u/ jew telf ta ’ ċelloli parenkimali) f’ firien wara 104 ġimgħa fuq doża ta ’ 20 sa 60 mg/ kg/ jum (3 sa 10 darbiet aqwa mill- medja fi stat stabbli ta ’ l- AUC fl- akbar doża rakkomandata għall- bnedmin) u żieda ta ’ tumuri adrenokortikali flimkien ma ’ adenomi taċ- ċelloli adrenokortikali/ karċinomi fi ġrieden tas- sess femminili b’ doża ta ’ 60 mg/ kg/ jum (14- il darba ikbar mill- medja ta ’ l- AUC fi stat stabbli fid- doża massima rakkomandata fil- bnedmin).
The highest nontumorigenic exposure in female rats was 7 times the human exposure at the recommended dose.
L- ogħla espożizzjoni li ma tirriżultax f' tumur f 'firien nisa kienet 7 darbiet l- espożizzjoni umana bid- doża rakkommondata.
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).
35 ħalq (1 sa 3 darbiet iktar mill- medja ta ’ l- AUC fi stat stabbli fid- doża massima rakkomandata fil - bnedmin jew 16 sa 81 darba iktar mid- doża massima rakkomandata fil- bniedem imkejla bħala mg/ m2).
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.
Iżda l- konċentrazzjoni tal- konjugi sulfatizzati ta ’ idroxi aripiprazole fil- bile tal- bniedem 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.
Based on results of a full range of standard genotoxicity tests, aripiprazole was considered non-genotoxic.
Minn riżultati ta ’ serje sħiħa ta ’ testijiet normali fuq l- effett tossiku fuq il- ġeni, ġie meqjus li aripiprazole ma kellha l- ebda effett tossiku fuq il- ġeni.
Aripiprazole did not impair fertility in reproductive toxicity studies.
Aripiprazole ma ’ naqqsetx il- fertilità fi studji dwar tossiċita` fuq is- sistema riproduttiva.
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.
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.
Maternal toxicity occurred at doses similar to those eliciting developmental toxicity.
Effett tossiku fuq l- omm intwera b’ dożi simili għal dawk li jagħmlu effett tossiku fuq l- iżvilupp.
Lactose monohydrate Maize starch Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate
Lactose monohydrate Maize starch Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate
Yellow iron oxide (E172)
Iron oxide isfar (E172)
33 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa 'mill- umdità.
Aluminium perforated unit dose blisters in cartons of 14 x 1, 28 x 1, 49 x 1, 56 x 1, 98 x 1 tablets.
Folji ta 'l- aluminju perforati għal unità ta' doża f' kartun ta '14 x 1, 28 x 1, 49 x 1, 56 x 1, 98 x 1 pillola.
Not all pack sizes may be marketed.
Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal- skop kummerċjali.
Hunton House Highbridge Business Park, Oxford Road Uxbridge - Middlesex UB8 1HU - United Kingdom
Hunton House Highbridge Business Park, Oxford Road Uxbridge - Middlesex UB8 1HU - Ir- Renju Unit
Date of first authorisation:
Data ta 'l- ewwel awtorizzazzjoni:
4 June 2004
4 ta 'Ġunju 2004
{MM/ YYYY}
{XX/ SSSS}
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta 'l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
ABILIFY 30 mg tablets
ABILIFY 30 mg pilloli
Each tablet contains 30 mg of aripiprazole.
Kull pillola għandha 30 mg ta 'aripiprazole.
186.54 mg lactose per tablet
186. 54 mg lactose kull pillola
Tablet Round and pink, engraved with "A-011" and "30" on one side.
Pillola Tonda u roża, imnaqqxa b '"A- 011" u "30" fuq naħa waħda.
ABILIFY is indicated for the treatment of schizophrenia.
ABILIFY huwa indikat għat- trattament ta 'skizofrenija.
ABILIFY is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).
ABILIFY huwa indikat għat- trattament ta ’ episodji manijaċi serji f’ Disturb Bipolari I u għall - prevenzjoni ta ’ episodju manijaku ġdid f’ pazjenti li esperjenzaw episodji predominantament manijaċi u li l- episodji manijaċi tagħhom irrispondew għal trattament ta ’ aripiprazole (ara sezzjoni 5. 1).
The recommended starting dose for ABILIFY is 10 or 15 mg/ day with a maintenance dose of 15 mg/ day administered on a once-a-day schedule without regard to meals.
Id- doża tal- bidu rakkomandata għal ABILIFY hija ta '10 jew 15 mg/ jum b' doża ta' manteniment ta '15 mg/ jum mogħtija fuq skeda ta' waħda kull jum mingħajr attenzjoni lejn l- ikliet.
ABILIFY is effective in a dose range of 10 to 30 mg/ day.
ABILIFY huwa effettiv f' doża b' firxa bejn 10 sa 30 mg/ jum.
Enhanced efficacy at doses higher than a daily dose of 15 mg has not been demonstrated although individual patients may benefit from a higher dose.
Ma ntweritx effikaċja mtejba b' doża ogħla minn doża ta 'kuljum ta' 15 mg għalkemm pazjenti individwali jistgħu jibbenefikaw minn doża ogħla.
The maximum daily dose should not exceed 30 mg.
Id- doża massima ta 'kuljum ma għandhiex taqbeż it- 30 mg.
Manic episodes:
Episodji manijaċi:
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).
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).
Some patients may benefit from a higher dose.
Xi pazjenti jistgħu jibbenefikaw minn doża ogħla.
The maximum daily dose should not exceed 30 mg.
Id- doża massima ta ’ kuljum ma għandhiex taqbeż 30 mg.
For preventing recurrence of manic episodes in patients who have been receiving aripiprazole, continue therapy at the same dose.
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, kompli bit- terapija bl- istess doża.
Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status.
Għandhom jiġu kkunsidrati aġġustamenti fid- dożaġġ ta ’ kuljum, inkluż tnaqqis fid- doża fuq il- bażi ta ’ l- istejtus kliniku.
Children and adolescents: there is no experience in children and adolescents under 18 years of age.
Tfal u adoloxxenti: m' hemmx esperjenza dwar l- użu fit- tfal u fl- adolexxenti taħt it- 18- il sena.
Patients with hepatic impairment: no dosage adjustment is required for patients with mild to moderate hepatic impairment.
Pazjenti b’ indeboliment epatiku: m’ hemmx bżonn ta 'aġġustament tad- doża f’ pazjenti b’ mard tal - fwied ħafif sa moderat.
In patients with severe hepatic impairment, the data available are insufficient to establish recommendations.
F’ pazjenti b’ indeboliment tal- fwied sever, l- informazzjoni disponibbli hija insuffiċjenti biex tistabbilixxi rakkomandazzjonijiet.
In these patients dosing should be managed cautiously.
F’ dawn il- pazjenti d- doża għandha tiġi
35 maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
Iżda wieħed għandu juża d- doża massima ta ’ kuljum ta ’ 30 mg b’ attenzjoni f’ pazjenti b' indeboliment tal- fwied sever (ara sezzjoni 5. 2).
Patients with renal impairment: no dosage adjustment is required in patients with renal impairment.
Pazjenti b’ indeboliment renali: m’ hemmx għalfejn tbiddel id- doża f’ pazjenti b’ mard tal- kliewi.
Elderly: the effectiveness of ABILIFY in the treatment of schizophrenia and Bipolar I Disorder in patients 65 years of age or older has not been established.
Anzjani: l- effettività ta ’ ABILIFY fit- trattament ta ’ l- iskizofrenija u ta ’ Disturb Bipolari I għadha ma ġietx stabbilita f’ pazjenti li għandhom 65 sena jew aktar.
Owing to the greater sensitivity of this population, a lower starting dose should be considered when clinical factors warrant (see section 4.4).
Minħabba li din il- popolazzjoni hija iktar sensittiva, wieħed għandu jikkonsidra li jibda b’ doża iżgħar meta s- sinjali kliniċi juru l- bżonn ta ’ dan (ara sezzjoni 4. 4).
Gender: no dosage adjustment is required for female patients as compared to male patients (see section 5.2).
Sess: m’ hemmx bżonn li tbiddel id- doża għal pazjenti nisa meta mqabbla ma ’ pazjenti rġiel (ara sezzjoni 5. 2).
Smoking status: according to the metabolic pathway of ABILIFY no dosage adjustment is required for smokers (see section 4.5).
Tipjip: minħabba il- mod kif jiġi metabolizzat ABILIFY m’ hemmx bżonn aġġustament tad- doża f’ dawk li jpejpu (ara sezzjoni 4. 5).
When concomitant administration of potent CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, the aripiprazole dose should be reduced.
Meta aripiprazole tingħata ma ’ inibituri potenti ta ’ CYP3A4 jew CYP2D6, id- doża ta ’ aripiprazole għandha titnaqqas.
When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased (see section 4.5).
Meta ma jibqax jingħata l- inibitur ta ’ CYP3A4 jew CYP2D6, id- doża ta ’ aripiprazole għandha tiżdied (ara sezzjoni 4. 5).
When concomitant administration of potent CYP3A4 inducers with aripiprazole occurs, the aripiprazole dose should be increased.
Meta sustanzi potenti li jistimolaw CYP3A4 jingħataw ma ’ aripiprazole, id- doża ta ’ aripiprazole għandha tiżdied.
When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should then be reduced to the recommended dose (see section 4.5).
Meta s- sustanza li tistimola CYP3A4 ma tibqax tingħata ma ’ aripiprazole, id- doża ta ’ aripiprazole għandha titnaqqas sad- doża rakkomandata (ara sezzjoni 4. 5).
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva għas- sustanza( i) attiva( i) jew għal xi sustanzi mhux attivi.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Waqt it- trattament ta ’ kontra l- psikożi, il- pazjent jista ’ jdum ħafna ġranet jew xi ftit ġimgħat biex juri titjib fil- kundizzjoni klinika tiegħu.
Patients should be closely monitored throughout this period.
Il- pazjenti għandhom jiġu segwiti mill- qrib matul dan il- perijodu kollu.
The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and in some cases has been reported early after initiation or switch of antipsychotic therapy, including treatment with aripiprazole (see section 4.8).
Hemm l- eżistenza ta 'tendenzi suwiċidjali f' mard psikotiku u disturbi fil- burdati u f' xi każijiet ġiet irrappurtata hekk kif bdiet jew inbidlet il- kura bl- antipsikotiċi, inkluża l- kura bl- aripiprazole (ara taqsima 4. 8).
Close supervision of high-risk patients should accompany antipsychotic therapy.
F' pazjenti b' riskju għoli l- kura bl- antipsikotiċi għandha tkun akkumpanjata b' sorveljanza mill- qrib.
Results of an epidemiological study found that there was no increased risk of suicidality with aripiprazole compared to other antipsychotics among patients with bipolar disorder.
Riżultati ta ’ studju epidemijoloġiku sab illi ma kien hemm ebda żieda fir- riskju ta ’ suwiċidju b’ aripiprazole meta mqabbel ma ’ antipsikotiċi oħrajn fost pazjenti b’ disturbi bipolari.
Cardiovascular disorders:
Disturbi kardjovaskulari:
Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications) or hypertension, including accelerated or malignant.
L- aripiprazole għandu jintuża b' kawtela f' pazjenti magħrufin li għandhom mard kardjovaskulari (passat ta 'infart mijokardjali jew mard iskemiku tal- qalb, attakk tal- qalb, jew anormalitajiet ta' trasmissjoni), mard ċerebrovaskulari, kundizzjonijiet li jippredisponu lill- pazjent għall- pressjoni baxxa ħafna (deidratazzjoni, ipovolemja, u kura b' medikazzjonijiet tal- pressjoni) jew pressjoni għolja, inkluża dik mgħaġġla jew mhux kontrollabbli.
Conduction abnormalities:
Anormalitajiet ta 'trasmissjoni:
In clinical trials of aripiprazole, the incidence of QT prolongation was comparable to placebo.
Fi provi kliniċi ta 'aripiprazole, l- inċidenza ta' tkarkir tal- QT kien jinkompara mal- plaċebo.
As with other antipsychotics, aripiprazole should be used with caution in patients with a family history of QT prolongation.
L- istess bħal antipsikotiċi oħra, l- aripiprazole għandu jintuża b' kawtela f' pazjenti fejn kien hemm tkarkir tal- QT fl- istorja tal- familja.
Tardive Dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
Diskineżja li tiżviluppa fit- tard: fi provi kliniċi li damu sena jew inqas, kien hemm rapporti mhux komuni li waqt it- trattament b’ aripiprazole il- pazjent żviluppa diskineżja.
If signs and symptoms of tardive dyskinesia appear in a patient on ABILIFY, dose reduction or discontinuation should be considered.
Jekk il- pazjent li qiegħed jieħu ABILIFY juri sinjali u sintomi ta ’ diskineżja li tiżviluppa fit- tard, wieħed għandu jikkonsidra li jnaqqas id- doża jew iwaqqaf it- trattament.
These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Dawn is- sintomi jistgħu imorru għall- agħar jew anke jibdew wara li jitwaqqaf it- trattament.
Neuroleptic Malignant Syndrome (NMS):
39 Sindromu Newrolettiku malinn (NMS):
NMS is a potentially fatal symptom complex associated with antipsychotic medicinal products.
NMS huwa grupp ta ’ sintomi li jista ’ jwassal għall- mewt, li jinstab meta jittieħdu mediċini kontra l- psikosi.
In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
Fi provi kliniċi, ġew irrapportati xi każijit rari ta ’ NMS waqt it- trattament b’ aripiprazole.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered
Klinikament NMS jista ’ juri deni, muskoli jibbiesu, stat mentali mibdul u evidenza ta ’ instabilità tas- sistema autonomika (polz mhux regolari jew pressjoni mhux normali, qalb tħabbat iktar mis- soltu, għaraq, u qalb ma tħabbatx regolari).
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Sinjali oħra jistgħu jkunu livell għoli tal- kreatinina phosphokinase, myoglobulin fl- awrina (rabdomajoliżi), u mard tal - kliewi akut.
However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported.
Madankollu, ġew irrapurtai wkoll żidiet ta 'kreatinina fosfoinejż u rabdomajoliżi, mhux neċessarjemant assoċjati ma' NMS.
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicinal products, including ABILIFY, must be discontinued.
Jekk il- pazjent juri sinjali u sintomi ta ’ NMS, jew inkella jitlagħlu d- deni mingħajr sinjali oħra ta ’ NMS, wieħed għandu jwaqqaf il- prodotti mediċinali ta ’ kontra l - psikożi kollha, inkluż ABILIFY.
Seizure: in clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole.
Konvulżjoni: fi provi kliniċi, ġew irrappurtati xi każijiet rari ta ’ konvulżjoni waqt it- trattament b’ aripiprazole.
Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures.
Għalhekk wieħed għandu juża aripiprazole b’ attenzjoni f’ pazjenti li għandhom storja ta ’ mard tal- konvulżjoni jew ibatu minn mard li huwa assoċjat mal- konvulżjoni.
Elderly patients with dementia-related psychosis:
Pazjenti anzjani b' psikosi relatata ma 'dimenzja:
Increased mortality: in three placebo-controlled trials (n= 938; mean age:
Rata ta 'mwiet ogħla: fi tliet provi kontrollati minn plaċebo (n= 938; età medja:
82.4 years; range:
82. 4 snin; medda:
56-99 years) of aripiprazole in elderly patients with psychosis associated with Alzheimer's disease, patients treated with aripiprazole were at increased risk of death compared to placebo.
56- 99 sena) ta 'aripiprazole f' pazjenti anzjani bil- psikosi assoċjat mal- marda Alzheimer, pazjenti kkurati bl- aripiprazole kellhom riskju ogħla ta' mewt imqabbla mal- plaċebo.
The rate of death in aripiprazole-treated patients was 3.5% compared to 1.7% in the placebo group.
Ir- rata ta 'mwiet f' pazjenti fuq kura bl- aripiprazole kienet 3. 5% imqabbla ma' 1. 7% fil- grupp ta 'plaċebo.