qanastek/EMEA-V3 huggingface dataset:
Although the causes of deaths were varied, most of the deaths appeared to be either cardiovascular (e. g. heart failure, sudden death) or infectious (e. g. pneumonia) in nature.
Għalkemm il- kawżi tal - mewt kienu varjati, il- biċċa il- kbira ta 'l- imwiet dehru li kienu jew kardjovaskulari (eż. attakk tal- qalb, mewt zopptu) jew ta' natura infettiva (eż. pnewmonja).
Hypersensitivity: as with other medications hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
40 Sensittività eċċessiva: bħalma jiġri b’ medikazzjonijiet oħra, jistgħu jseħħu reazzjonijiet ta ’ sensittività eċċessiva, ikkaratterizzati minn sintomi ta ’ allerġija, b’ aripiprazole (ara sezzjoni 4. 8).
37 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
ABILIFY dose should be doubled when concomitant administration of ABILIFY occurs with carbamazepine.
41 Id- doża ta ’ ABILIFY għandha tiġi rduppjata meta ABILIFY tingħata ma ’ carbamazepine.
38 When either valproate or lithium were administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations.
Meta valproate jew lithium ingħataw b’ mod konkomitanti ma ’ aripiprazole, ma kienx hemm l- ebda tibdil ta ’ importanza klinika fil- livell ta ’ aripiprazole.
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*
42 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 *
39 Extrapyramidal symptoms (EPS):
Sintomi ekstrapiramidali (EPS):
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 43
The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
44 medikament importanti kienu jinkludu ħedla ta 'rqad, telf temporanju ta' koxjenza u sintomi ekstrapiramidali.
41 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.
Weight gain: in clinical trials aripiprazole has not been shown to induce clinically relevant weight gain.
45 Żieda fil- piż: fi provi kliniċi l- aripiprazole orali ma deherx li jwassal għal żieda fil- piż li hija klinikament relevanti.
42 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.
Elimination:
46 Eliminazzjoni:
43 Hepatic Disease:
Mard tal- fwied:
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).
47 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).
Red iron oxide (E172)
Iron oxide aħmar (E172)
44 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
ABILIFY 10 mg orodispersible tablets
ABILIFY 10 mg pilloli li jinħallu fil- ħalq
Each orodispersible tablet contains 10 mg of aripiprazole.
Kull pillola li tinħall fil- ħalq għandha 10 mg ta 'aripiprazole.
2 mg aspartame (E951) per orodispersible tablet
2 mg aspartame (E951) għal kull pillola li tinħall fil- ħalq
Orodispersible tablet Round and pink, marked with "A" over "640" on one side and "10" on the other.
Pillola li tinħall fil- ħalq tondi u roża, immarkata b '"A" fuq "640" fuq naħa u "10" fuq in- naħa l- oħra.
ABILIFY is indicated for the treatment of schizophrenia.
ABILIFYhuwa indikat għat- trattament ta 'skizofrenija.
Schizophrenia:
Skizofrenija:
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 ABILIFYhija 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.
ABILIFYhuwa effettiv f' doża b' firxa bejn 10 sa 30 mg/ jum.
The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disperse in saliva.
Il- pillola li tinħall fil- ħalq għandha titpoġġa ġol- ħalq fuq l- ilsien, fejn titħallat malajr mal- bżieq.
It can be taken with or without liquid.
Tista 'tittieħed ma' likwidu jew mingħajr likwidu.
Removal of the intact orodispersible tablet from the mouth is difficult.
Huwa diffiċli li titneħħa l- pillola li tinħall fil- ħalq sħiħa minn ġol- ħalq.
Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Minħabba li l- pillola li tinħall fil- ħalq hija fraġli, għandha titieħed immedjatament wara li tinfetaħ il- folja.
Alternatively, disperse the tablet in water and drink the resulting suspension.
Inkella, ħallat il- pillola ma 'l- ilma u ixrob is- sospensjoni li jkollok.
46 The orodispersible tablets may be used as an alternative to ABILIFY tablets for patients who have difficulty to swallow ABILIFY tablets (see also section 5.2).
50 Il- pilloli li jinħallu fil- ħalq jistgħu jintużaw bħala alternattiva għall- pilloli ABILIFY għal pazjenti li għandhom diffikultà illi jibilgħu il- pilloli ABILIFY (ara wkoll sezzjoni 5. 2).
Patients with hepatic impairment: no dosage adjustment is required for patients with mild to moderate hepatic impairment.
Pazjenti b’ indeboliment epatiku: m’ hemmx bżonn aġġustament tad- doża f’ pazjenti b’ mard tal- fwied ħafif sa moderat.
In these patients dosing should be managed cautiously.
F’ dawn il- pazjenti d- doża għandha tiġi kkontrollata b’ kawtela.
However, the 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).
Smoking status: according to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers (see section 4.5).
Stat ta 'tipjip: minħabba il- mod kif jiġi metabolizzat aripiprazole m’ hemmx bżonn aġġustar tad- doża f’ dawk li jpejpu (ara sezzjoni 4. 5).
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 irrapurtata hekk kif bdiet jew inbidlet il- kura bl- antipsikotiċi, inkluża l- kura bl- aripiprazole (ara taqsima 4. 8).
Conduction abnormalities:
51 Anormalitajiet ta 'trasmissjoni:
47 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.
Neuroleptic Malignant Syndrome (NMS):
Sindromu Newrolettiku malinn (NMS):
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
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).
Weight gain has been reported post-marketing among patients prescribed ABILIFY.
Ġiet rrapurtata żjieda fil- piż wara il- bejgħ fost pazjenti li ngħataw ABILIFY.
When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary adenoma.
52 ta 'riskju sinifikanti bħal passat ta' dijabete, disturb tat- tirojde jew adenoma tal- glandola pitwitarja.
48 Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
Dysphagia: dysmotility ta 'l- esofagu u tan- nifs ġew assoċjti ma' l- użu ta 'drogi antipsikotiċi, inkluż ABILIFY.
ABILIFY orodispersible tablets contain aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria.
Phenylketonurics: il- pilloli li jinħallu fil- ħalq ABILIFY għandhom l- aspartame, sors ta 'phenylalanine li jista' jagħmel ħsara lil nies bil- phenylketonuria.
Hypersensitivity: as with other medications hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
Sensittività eċċessiva: bħalma jiġri b’ medikazzjonijiet oħra, jistgħu jseħħu reazzjonijiet ta ’ sensittività eċċessiva, ikkaratterizzati minn sintomi ta ’ allerġija, b’ aripiprazole (ara sezzjoni 4. 8).
In a clinical trial in healthy subjects, a potent inhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63% and 37%, respectively.
Fi studju kliniku f’ pazjenti b’ saħħithom, inibitur potenti ta ’ CYP3A4 (ketoconazole) żied l- AUC u s - Cmax ta ’ aripiprazole b’ 63% u 37% rispettivament.
When weak inhibitors of CYP3A4 (e. g., diltiazem or escitalopram) or CYP2D6 are used concomitantly with ABILIFY, modest increases in aripiprazole concentrations might be expected.
53 Meta inibituri ħfief ta 'CYP3A4 (eż., diltiazem jew escitalopram) jew CYP2D6 jintużaw b' mod konkomitanti ma' ABILIFY, wieħed jista 'jistenna li jkun hemm żidiet żgħar fil- konċentrazzjonijiet ta' aripiprazole.
Similarly, for dehydro-aripiprazole the geometric means
Wara l- amministrazzjoni komkomitanti ta’ carbamazepine, stimulant potenti ta ’ CYP3A4, il- medja ġeometrika tas - Cmax 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.
49 of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
Fl- istess mod, għad- dehydro - aripiprazole, wara li ngħata carbamazepine fl- istess waqt, il- medja ġeometrika tas - Cmax u l- AUC kienet ta ’ 69% u 71% iktar baxxa, rispettivament, minn dik fil- pazjenti li kienu qegħdin jieħdu il- kura ta aripiprazole waħidha.
ABILIFY dose should be doubled when concomitant administration of ABILIFY occurs with carbamazepine.
Id- doża ta ’ ABILIFY għandha tiġi rduppjata meta ABILIFY tingħata ma ’ carbamazepine.
When either valproate or lithium were administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations.
Meta valproate jew lithium ingħataw b’ mod konkomitanti ma ’ aripiprazole, ma kienx hemm l- ebda tibdil ta ’ importanza klinika fil- livell ta ’ aripiprazole.
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*):
54 L- effetti mhux mixtieqa li ġejjin ġraw aktar spiss minn (≥ 1/ 100) mill- placebo, jew ġew identifikati bħala reazzjonijiet avversi possibilment relevanti klinikament (*):
50 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*
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 *
Extrapyramidal symptoms (EPS):
Sintomi ekstrapiramidali (EPS):
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 55 haemoglobin
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
51 Nervous system disorders:
Disturbi fis- sistema nervuża:
The potentially medically important signs and symptoms observed included lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea.
56 jinkludu letarġija, żjieda fil- pressjoni tad- demm, ħedla ta 'rqad, tatikardija, nawsja, remettar u dijarea.
The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
Is- sinjali u sintomi rapurtati li possibbilment huma medikament importanti kienu jinkludu ħedla ta 'rqad, telf temporanju ta' koxjenza u sintomi ekstrapiramidali.
52 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 Cmax ta ’ aripiprazole bejn wieħed u ieħor b ’ 41% u AUC bejn wieħed u ieħor b ’ 51%, li jissuġġerixxi li l- faħam jista jkun effettiv għall - kura ta ’ doża eċċessiva.
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 Disordni Bipolari I tkun medjatur bejn taħlita ta' agoniżmu parzjali tar- reċetturi dopamina D2 u serotonina 5HT1a, u antagoniżmu tar - reċetturi serotonina 5HT2.
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.
57 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.
Żieda fil- piż: fi provi kliniċi l- aripiprazole orali ma deherx li jwassal għal żieda fil- piż li hija klinikament relevanti.
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
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.
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.
Aripiprazole orodispersible tablet is bioequivalent to aripiprazole tablets, with a similar rate and extent of absorption.
Il- pillola orodispersabbli ta 'Aripiprazole hija bijoekwivalenti għall- pilloli aripiprazole, b' rata u firxa ta' assorbiment simili.
Aripiprazole orodispersible tablets may be used as an alternative to aripiprazole tablets.
Il- pilloli li jinħallu fil- ħalq Aripiprazole jistgħu jintużaw bħala alternettiva għall- pilloli aripiprazole.
Metabolism:
58 Metaboliżmu:
54 Pharmacokinetics in special patient groups
Farmakokinetiċi fi gruppi speċjali
Hepatic Disease:
Mard tal- fwied:
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
The highest nontumorigenic exposure in female rats was 7 times the human exposure at the recommended dose.
59 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).
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).
Kien hemm ukoll każijiet ta ’ ġebla minħabba preċipitazzjoni tal- konjugi sulfatizzati tal- metaboliti idroġenizzati ta ’ aripiprazole fil- bile tax- xadini wara li ħadu ħafna dożi ta ’ 25 sa 125 mg/ kg/ jum mill - 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).
Aripiprazole did not impair fertility in reproductive toxicity studies.
Aripiprazole ma naqqasx il- fertilità fi studji dwar tossiċita` fuq is- sistema riproduttiva.
Calcium silicate Croscarmellose sodium Crospovidone Silicon dioxide Xylitol Microcrystalline cellulose Aspartame (E951) Acesulfame potassium Vanilla flavour (including vanillin and ethyl vanillin) Tartaric acid Magnesium stearate
Calcium silicate Croscarmellose sodium Crospovidone Silicon dioxide Xylitol Microcrystalline cellulose Aspartame (E951) Acesulfame potassium Togħma ta 'vanilla (inklużi vanillin u ethyl vanillin) Tartaric acid Magnesium stearate
Carton of 14 x 1 tablets in cold-formed aluminium perforated unit dose blisters.
Kartuna ta '14 x 1 pillola f' folji ta' l- aluminju iffurmati fil- kiesaħ b' unità perforata.
Carton of 28 x 1 tablets in cold-formed aluminium perforated unit dose blisters.
60 Kartuna ta '28 x 1 pillola f' folji ta' l- aluminju iffurmati fil- kiesaħ b' unità perforata.
Carton of 49 x 1 tablets in cold-formed aluminium perforated unit dose blisters.
Kartuna ta '49 x 1 pillola f' folji ta' l- aluminju iffurmati fil- kiesaħ b' unità perforata.
56 Date of first authorisation:
Data ta 'l- ewwel awtorizzazzjoni:
ABILIFY 15 mg orodispersible tablets
ABILIFY 15 mg pilloli li jinħallu fil- ħalq
Each orodispersible tablet contains 15 mg of aripiprazole.
Kull pillola li tinħall fil- ħalq għandha 15 mg ta 'aripiprazole.
3 mg aspartame (E951) per orodispersible tablet
3 mg aspartame (E951) għal kull pillola li tinħall fil- ħalq
Orodispersible tablet Round and yellow, marked with "A" over "641" on one side and "15" on the other.
Pillola li tinħall fil- ħalq tondi u isfar, immarkata b '"A" fuq "641" fuq naħa u "15" fuq in- naħa l- oħra.
58 The orodispersible tablets may be used as an alternative to ABILIFY tablets for patients who have difficulty to swallow ABILIFY tablets (see also section 5.2).
62 Il- pilloli li jinħallu fil- ħalq jistgħu jintużaw bħala alternattiva għall- pilloli ABILIFY għal pazjenti li għandhom diffikultà illi jibilgħu il- pilloli ABILIFY (ara wkoll sezzjoni 5. 2).
Conduction abnormalities:
63 Anormalitajiet ta 'trasmissjoni:
59 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.
When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary adenoma.
64 ta 'riskju sinifikanti bħal passat ta' dijabete, disturb tat- tirojde jew adenoma tal- glandola pitwitarja.
60 Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
Dysphagia: dysmotility ta 'l- esofagu u tan- nifs ġew assoċjti ma' l- użu ta 'drogi antipsikotiċi, inkluż ABILIFY.
When weak inhibitors of CYP3A4 (e. g., diltiazem or escitalopram) or CYP2D6 are used concomitantly with ABILIFY, modest increases in aripiprazole concentrations might be expected.
65 Meta inibituri ħfief ta 'CYP3A4 (eż., diltiazem jew escitalopram) jew CYP2D6 jintużaw b' mod konkomitanti ma' ABILIFY, wieħed jista 'jistenna li jkun hemm żidiet żgħar fil- konċentrazzjonijiet ta' aripiprazole.
61 of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
Fl- istess mod, għad- dehydro - aripiprazole, wara li ngħata carbamazepine fl- istess waqt, il- medja ġeometrika tas - Cmax u l- AUC kienet ta ’ 69% u 71% iktar baxxa, rispettivament, minn dik fil- pazjenti li kienu qegħdin jieħdu il- kura ta aripiprazole waħidha.
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*):
66 L- effetti mhux mixtieqa li ġejjin ġraw aktar spiss minn (≥ 1/ 100) mill- placebo, jew ġew identifikati bħala reazzjonijiet avversi possibilment relevanti klinikament (*):
62 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*
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 *
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 67 haemoglobin
63 Nervous system disorders:
Disturbi fis- sistema nervuża:
The potentially medically important signs and symptoms observed included lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea.
68 jinkludu letarġija, żjieda fil- pressjoni tad- demm, ħedla ta 'rqad, tatikardija, nawsja, remettar u dijarea.
64 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 Cmax ta ’ aripiprazole bejn wieħed u ieħor b ’ 41% u AUC bejn wieħed u ieħor b ’ 51%, li jissuġġerixxi li l- faħam jista jkun effettiv għall - kura ta ’ doża eċċessiva.
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.
69 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.
Metabolism:
70 Metaboliżmu:
66 Pharmacokinetics in special patient groups
Farmakokinetiċi fi gruppi speċjali
The highest nontumorigenic exposure in female rats was 7 times the human exposure at the recommended dose.
71 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).
Carton of 28 x 1 tablets in cold-formed aluminium perforated unit dose blisters.
72 Kartuna ta '28 x 1 pillola f' folji ta' l- aluminju iffurmati fil- kiesaħ b' unità perforata.
68 Date of first authorisation:
Data ta 'l- ewwel awtorizzazzjoni:
ABILIFY 30 mg orodispersible tablets
ABILIFY 30 mg pilloli li jinħallu fil- ħalq
Each orodispersible tablet contains 30 mg of aripiprazole.
Kull pillola li tinħall fil- ħalq għandha 30 mg ta 'aripiprazole.
6 mg aspartame (E951) per orodispersible tablet
6 mg aspartame (E951) għal kull pillola li tinħall fil- ħalq
Orodispersible tablet Round and pink, marked with "A" over "643" on one side and "30" on the other.
Pillola li tinħall fil- ħalq tondi u roża, immarkata b '"A" fuq "643" fuq naħa u "30" fuq in- naħa l- oħra.
70 The orodispersible tablets may be used as an alternative to ABILIFY tablets for patients who have difficulty to swallow ABILIFY tablets (see also section 5.2).
74 Il- pilloli li jinħallu fil- ħalq jistgħu jintużaw bħala alternattiva għall- pilloli ABILIFY għal pazjenti li għandhom diffikultà illi jibilgħu il- pilloli ABILIFY (ara wkoll sezzjoni 5. 2).
Conduction abnormalities:
75 Anormalitajiet ta 'trasmissjoni:
71 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.
When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary adenoma.
76 ta 'riskju sinifikanti bħal passat ta' dijabete, disturb tat- tirojde jew adenoma tal- glandola pitwitarja.
72 Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
Dysphagia: dysmotility ta 'l- esofagu u tan- nifs ġew assoċjti ma' l- użu ta 'drogi antipsikotiċi, inkluż ABILIFY.
When weak inhibitors of CYP3A4 (e. g., diltiazem or escitalopram) or CYP2D6 are used concomitantly with ABILIFY, modest increases in aripiprazole concentrations might be expected.
77 Meta inibituri ħfief ta 'CYP3A4 (eż., diltiazem jew escitalopram) jew CYP2D6 jintużaw b' mod konkomitanti ma' ABILIFY, wieħed jista 'jistenna li jkun hemm żidiet żgħar fil- konċentrazzjonijiet ta' aripiprazole.
73 of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
Fl- istess mod, għad- dehydro - aripiprazole, wara li ngħata carbamazepine fl- istess waqt, il- medja ġeometrika tas - Cmax u l- AUC kienet ta ’ 69% u 71% iktar baxxa, rispettivament, minn dik fil- pazjenti li kienu qegħdin jieħdu il- kura ta aripiprazole waħidha.
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*):
78 L- effetti mhux mixtieqa li ġejjin ġraw aktar spiss minn (≥ 1/ 100) mill- placebo, jew ġew identifikati bħala reazzjonijiet avversi possibilment relevanti klinikament (*):
74 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*
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 *
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 79 haemoglobin
75 Nervous system disorders:
Disturbi fis- sistema nervuża:
The potentially medically important signs and symptoms observed included lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea.
80 jinkludu letarġija, żjieda fil- pressjoni tad- demm, ħedla ta 'rqad, tatikardija, nawsja, remettar u dijarea.
76 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 Cmax ta ’ aripiprazole bejn wieħed u ieħor b ’ 41% u AUC bejn wieħed u ieħor b ’ 51%, li jissuġġerixxi li l- faħam jista jkun effettiv għall - kura ta ’ doża eċċessiva.
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.
81 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.
Metabolism:
82 Metaboliżmu:
78 Pharmacokinetics in special patient groups
Farmakokinetiċi fi gruppi speċjali
The highest nontumorigenic exposure in female rats was 7 times the human exposure at the recommended dose.
83 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).
Carton of 28 x 1 tablets in cold-formed aluminium perforated unit dose blisters.
84 Kartuna ta '28 x 1 pillola f' folji ta' l- aluminju iffurmati fil- kiesaħ b' unità perforata.
80 Date of first authorisation:
Data ta 'l- ewwel awtorizzazzjoni:
ABILIFY 1 mg/ ml oral solution
ABILIFY 1 mg/ ml soluzzjoni orali
Each ml contains 1 mg of aripiprazole.
Kull ml fih 1 mg ta 'aripiprazole.
200 mg fructose per ml 400 mg sucrose per ml 1.8 mg methyl parahydroxybenzoate (E218) per ml 0.2 mg propyl parahydroxybenzoate (E216) per ml
200 mg fructose għal kull ml 400 mg sucrose għal kul ml 1. 8 mg methyl parahydroxybenzoate (E218) għal kul ml 0. 2 mg propyl parahydroxybenzoate (E216) għal kul ml
Oral solution Clear, colourless to light yellow liquid.
Soluzzjoni orali Likwidu ċar, bla kuluri sa isfar ċar.
ABILIFY oral solution may be used as an alternative to ABILIFY tablets for patients who have difficulty swallowing ABILIFY tablets (see section 5.2).
ABILIFY soluzzjoni orali jista 'jintuża bħala alternattiva għal pilloli ABILIFY għal pazjenti li għandhom problema biex jibilgħu pilloli ABILIFY (ara sezzjoni 5. 2).
The recommended starting dose for ABILIFY is 10 or 15 mg/ day (i. e.
Id- doża tal- bidu rakkomandata għal ABILIFYhija ta '10 jew 15 mg/ jum (i. e.
10 or 15 ml solution/ day) with a maintenance dose of 15 mg/ day administered on a once-a-day schedule without regard to meals.
10 jew 15ml soluzzjoni/ kuljum) b' doża ta 'manteniment ta' 15 mg/ jum mogħtija fuq skeda ta 'waħda kull jum mingħajr attenzjoni lejn l- ikliet.
A calibrated measuring cup and a 2 ml calibrated dropper are included in the carton.
Tazza kkalibrata u dropper ikkalibrat ta ’ 2 ml huma fil- kartuna.
10 to 30 ml solution/ day).
ABILIFY huwa effettiv f' doża b' firxa bejn 10 sa 30 mg/ jum.
15 ml solution/ day) 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).
30 ml solution/ day).
Id- doża massima ta ’ kuljum ma għandhiex taqbeż 30 mg.
Recurrence prevention of manic episodes in Bipolar I Disorder:
Il- prevenzjoni ta ’ rikorrenza ta ’ episodji manijaċi f’ Disturbi Bipolari I
82 For preventing recurrence of manic episodes in patients who have been receiving aripiprazole, continue therapy at the same dose.
86 Biex tipprevjeni r- rikorrenza ta ’ episodji manijaċi f’ pazjenti li kienu qegħdin jirċievu aripiprazole, kompli bit- terapija bl- istess doża.
Gender: no dosage adjustment is required for female patients as compared to male patients (see sections 4.4 and 5.2).
Sess: m’ hemmx bżonn li tbiddel id- doża għal pazjenti nisa meta mqabbla ma ’ pazjenti rġiel (ara sezzjonijiet 4. 4 u 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 metaboliżżat ABILIFY m’ hemmx bżonn aġġustament tad- doża f’ dawk li jpejpu (ara sezzjoni 4. 5).
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 irrapurtata hekk kif bdiet jew inbidlet il- kura bl- antipsikotiċi, inkluża l- kura bl- aripiprazole (ara sezzjoni 4. 8).
Conduction abnormalities:
87 Anormalitajiet ta 'trasmissjoni:
83 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.
Neuroleptic malignant syndrome (NMS):
Sindromu Newrolettiku malinn (NMS):
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.
Hyperglycaemia and diabetes mellitus: hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotic agents, including ABILIFY.
Ipergliċemija u Dijabete mellitus: ipergliċemija, f' xi każi gravi u assoċjata ma 'ketoacidosis jew koma hyperosmolar jew mewt, ġiet irrapurtata f' pazjenti kkurati b' aġenti antipsikotiċi mhux tipiċi, inklużi ABILIFY.
When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary adenoma.
88 ta 'riskju sinifikanti bħal passat ta' dijabete, disturb tat- tirojde jew adenoma tal- glandola pitwitarja.
84 Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
Dysphagia: dysmotility ta 'l- esofagu u tan- nifs ġew assoċjti ma' l- użu ta 'drogi antipsikotiċi, inkluż ABILIFY.
Intolerance:
Intoleranza:
The oral solution contains fructose.
Is- soluzzjoni orali għandha l- fructose.
Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Pajenti bi problemi ereditarji rari ta 'intolleranza għall- fructose ma għandhomx jieħdu dan il- prodott mediċinali.
The oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Is- soluzzjoni orali għanha methyl parahydroxybenzoate u propyl parahydroxybenzoate li jistgħu jikkawżaw reazzjonijiet allerġiċi (possibilment li jibdew tard).
The oral solution contains sucrose.
Is- soluzzjoni orali għandha s- sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take the oral solution.
Pazjenti bi problemi ereditarji rari ta 'intolleranza għall- fructose, assorbiment ħażin ta' glucose- galactose jew nuqqas ta 'sucrase- isomaltase ma għandhomx jieħdu din is- soluzzjoni orali.
When concomitant administration of ketoconozole with ABILIFY occurs, ABILIFY dose should be reduced to approximately one-half of its prescribed dose.
89 ABILIFY għandha titnaqqas għal bejn wieħed u ieħor nofs id- doża preskritta.
85 When weak inhibitors of CYP3A4 (e. g., diltiazem or escitalopram) or CYP2D6 are used concomitantly with ABILIFY, modest increases in aripiprazole concentrations might be expected.
Meta inibituri ħfief ta 'CYP3A4 (eż., diltiazem jew escitalopram) jew CYP2D6 jintużaw b' mod konkomitanti ma' ABILIFY, wieħed jista 'jistenna li jkun hemm żidiet żgħar fil- konċentrazzjonijiet ta' aripiprazole.
No studies on the effect on the ability to drive and use machines have been performed.
90 Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*):
L- effetti mhux mixtieqa li ġejjin ġraw aktar spiss minn mill- placebo, jew ġew identifikati bħala reazzjonijiet avversi possibilment relevanti klinikament (*):
86 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*
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 *
Post-Marketing:
91 Wara l- bejgħ:
87 Nervous system disorders:
Disturbi fis- sistema nervuża:
agitation, nervousness; suicide attempt, suicidal ideation, and completed suicide (see section 4.4)
suwiċidju u twettiq ta ’ suwiċidju (ara sezzjoni 4. 4)
88 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 Cmax ta ’ aripiprazole bejn wieħed u ieħor b ’ 41% u AUC bejn wieħed u ieħor b’ 51%, li jissuġġerixxi li l- faħam jista jkun effettiv għall - kura ta ’ doża eċċessiva.
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 tkun medjatur bejn taħlita ta' agoniżmu parzjali tar- reċetturi dopamina D2 u serotonina 5HT1a, u antagoniżmu tar - reċetturi serotonina 5HT2.
ABILIFY is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.
93 ABILIFY huwa effettiv li jżomm titjib kliniku waqt kura kontinwa f’ pazjenti li wrew rispons fil- bidu tal- kura.
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).
Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/ kg, indicating extensive extravascular distribution.
F’ konċentrazzjonijiet terapewtiċi,
At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99% bound to serum proteins, binding primarily to albumin.
94 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 metaboliżżata b’ mod qawwi mill- fwied bi tlett metodi ta ’ biotransformazzjoni: deidroġinazzjoni, idroksilazzjoni u N- di- alkajlazzjoni.
Oral Solution:
Soluzzjoni Orali:
Aripiprazole is well absorbed when administered orally as the solution.
Aripiprazole huwa assorbit b' mod tajjeb meta mogġti mill- ħalq bħala soluzzjoni.
At equivalent doses, the peak plasma concentrations of aripiprazole (Cmax) from the solution were somewhat higher but the systemic
F' dożi ekwivalenti, il - konċentrazzjonijiet fil- plasma ta 'aripiprazole (Cmax) mis- soluzzjoni kienu kemm xejn ogħla imma l - espożizzjoni sistematika (AUC) kienet ekwivalenti għall- pilloli.
In a relative bioavailability study comparing the pharmacokinetics of 30 mg aripiprazole as the oral solution to 30 mg aripiprazole tablets in healthy subjects, the solution to the tablet ratio of geometric mean Cmax values was 122% (N = 30).
Fi studju ta 'bijodisponibilità relattiva li tikkompara l- farmakokinetika ta' 30 mg ta 'aripiprazole bħala soluzzjoni orali ma' 30 mg ta 'pilloli aripiprazole f' suġġetti b' saħħithom, il- proporzjoni tas- soluzzjoni għall- pilloli tal- medja ġeometrika tal - valuri Cmax kien ta' 122% (N = 30).
The single- dose pharmacokinetics of aripiprazole were linear and dose-proportional.
Il- farmakokinetiċi ta 'doża unika ta' aripiprazole kienu lineari u proporzjonati mad- doża.
5.3 Preclinical safety data
95 5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
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 (10 darbiet ikbar mill- medja ta ’ l- AUC fi stat stabbli fid- doża massima rakkomandata fil- bnedmin).