qanastek/EMEA-V3 huggingface dataset:
What is Abilify?
X' inhu Abilify?
Abilify is a medicine containing the active substance aripiprazole.
Abilify huwa mediċina li fiha s- sustanza attiva aripiprazole.
It is available as 5 mg, 10 mg, 15 mg and 30 mg tablets, as 10 mg, 15 mg and 30 mg orodispersible tablets (tablets that dissolve in the mouth), as an oral solution (1 mg/ ml) and as a solution for injection (7.5 mg/ ml).
Huwa disponibbli f' pilloli ta '5 mg, 10 mg, 15 mg u 30 mg, f' pilloli orodispersibbli (pilloli li jinħallu fil- ħalq) ta' 10 mg, 15 mg u 30 mg, f' soluzzjoni orali (1 mg/ ml) u f' soluzzjoni għal injezzjoni (7. 5 mg/ ml).
What is Abilify used for?
Għal xiex jintuża Abilify?
Abilify is used to treat adults with the following mental illnesses: • schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs); • bipolar I disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood.
Abilify jintuża fit- trattament ta 'adulti li jbatu minn dan il- mard mentali: • skizofrenija, marda mentali kkaratterizzata minn għadd ta' sintomi, fosthom disturbi fil- ħsieb u fid- diskors, alluċinazzjonijiet (il- pazjent jisma 'jew jara affarijiet li ma jeżistux), suspetti u delirji (ħsibijiet żbaljati); • disturb bipolari tat- tip I, marda mentali li biha l- pazjenti jkollhom episodji ta' maniji (perjodu anomalu ta 'burdata tajba), alternati b' perjodi ta' burdata normali.
They may also have episodes of depression.
Il- pazjenti jista 'jkollhom ukoll episodji ta' depressjoni.
Abilify is used to treat moderate to severe manic episodes and to prevent manic episodes in patients who have responded to the medicine in the past.
Abilify jintuża għat- trattament ta 'episodji ta' maniji minn moderati għal gravi u għall- prevenzjoni ta 'episodji ta' maniji f' pazjenti li rrispondew għall- mediċina fl- imgħoddi.
The solution for injection is used for the rapid control of agitation or disturbed behaviour when taking the medicine by mouth is not appropriate.
Is- soluzzjoni għall- injezzjoni tintuża għall- kontroll rapidu ta 'aġitazzjoni jew disturbi fl- imġiba meta mhuwiex adegwat li l- mediċina tittieħed mill- ħalq.
How is Abilify used?
Kif jintuża Abilify?
For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day.
Id- doża inizjali rakkomandata għall- iskizofrenija hija 10 jew 15 mg li tittieħed kuljum mill- ħalq.
The maintenance dose is 15 mg once a day, but higher doses may benefit some patients.
Id - doża ta 'manteniment hija 15mg darba kuljum, iżda xi pazjenti jistgħu jibbenefikaw minn dożi aktar qawwijin.
For bipolar disorder, the recommended starting dose is 15 mg by mouth once a day, either on its own or in combination with other medicines.
Id- doża inizjali rakkomandata għad- disturb bipolari hija 15 mg li tittieħed kuljum mill- ħalq, waħedha jew flimkien ma 'mediċini oħra.
Some patients may benefit from a higher dose.
Xi pazjenti jistgħu jibbenefikaw minn doża aktar qawwija.
To prevent manic episodes, the same dose should be continued.
Għall - prevenzjoni ta 'episodji ta' maniji, l- istess doża għandha titkompla.
For both illnesses, the oral solution or orodispersible tablets can be used in patients who have difficulty swallowing tablets.
Għaż- żewġ mardiet, fil- pazjenti li għandhom diffikultà jibilgħu l- pilloli, jistgħu jintużaw is- soluzzjoni orali jew il- pilloli orodispersibbli.
The orodispersible tablets are taken by being placed on the tongue, where they disintegrate quickly in the saliva, or by mixing them in water before swallowing.
Il- pilloli orodispersibbli jittieħdu billi jitpoġġew fuq l- ilsien, fejn jinħallu malajr bil- bżieq, jew inkella billi tħallathom ma 'l- ilma qabel tiblagħhom.
A second injection can be given from two hours after the first if necessary, but no more than three injections should be given in any 24-hour period.
Is- soluzzjoni għal injezzjoni hija biss għal użu qasir u għandha tiġi sostitwita bil- pilloli, bil- pilloli orodispersibbli jew bis- soluzzjoni orali mill- aktar fis possibbli: id- doża tas- soltu hija 9. 75 mg bħala injezzjoni unika fil - parti ta 'fuq tad- driegħ jew tal- gluteu (warrani), iżda jistgħu jirriżultaw effikaċi d- dożi bejn 5. 25 u
Abilify can be taken with or without food.
Abilify jittieħed anki fuq stonku vojt.
The daily dose of Abilify should not exceed 30 mg, but this dose should be used with caution in patients who have severe problems with their liver.
Id- doża ta 'kuljum ta' Abilify ma għandhiex taqbeż it- 30 mg, iżda din id- doża għandha tintuża b' kawtela f' pazjenti bi problemi gravi fil- fwied.
The dose of Abilify should be adjusted in patients who are taking other medicines that are broken down in the same way as Abilify.
Id- doża ta 'Abilify għandha tiġi aġġustata f' pazjenti fil- każ li l- pazjenti qegħdin jieħdu mediċini oħra li jiġu metabolizzati fl- istess mod bħal Abilify.
Abilify has not been studied in children aged below 18 years or adults aged over 65 years.
Abilify ma ġiex studjat fit- tfal ta 'età inqas minn 18- il sena jew adulti ta' età 'l fuq minn 65 sena.
How does Abilify work?
Kif jaħdem Abilify?
The active substance in Abilify, aripiprazole, is an antipsychotic medicine.
Is- sustanza attiva f' Abilify, aripiprazole, hija mediċina antipsikotika.
Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain.
Minkejja li mhuwiex magħruf eżatt kif taħdem, hija teħel ma 'diversi riċetturi differenti preżenti fuq is- superfiċje taċ- ċelluli tan - nervituri tal- moħħ.
This disrupts signals transmitted between brain cells by ‘ neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
B' dan il- mod, is- sinjali trasmessi bejn iċ- ċelluli tal- moħħ permezz tan - 'newrotrasmettituri' jiġu interrotti, jiġifieri s- sustanzi kimiċi li jippermettu ċ- ċelluli nervużi li jikkomunikaw bejniethom.
Aripiprazole is thought to act mainly by being a ‘ partial agonist ’ for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Aripiprazole jitqies li jaħdem prinċipalment bħala 'agonista parzjali' għar - riċetturi għan- newrotrasmettituri dopamina u 5- idrossitriptamina (5- hydroxytryptamine) (imsejħa wkoll serotonina).
This means that aripiprazole acts like 5-hydroxytryptamine and dopamine to activate the receptors, but to a lesser extent than the neurotransmitters.
Dan ifisser li apriprazole jaġixxi bħal 5- idrossitriptamina u d- dopamina biex jattiva r- riċetturi iżda inqas milli kieku kienu jaġixxu n- newrotrasmettituri.
Since dopamine and 5-hydroxytryptamine are involved in schizophrenia and bipolar disorder, aripiprazole helps to normalise the activity of the brain, reducing psychotic or manic symptoms and preventing them from returning.
Billi d- dopamina u 5 - idrossitriptamina huma involuti fl- iskizofrenija u fid- disturb bipolari, aripiprazole jgħin fin - normalizzazzjoni ta 'l- attività tal- moħħ, billi jnaqqas is- sintomi psikotiċi u ta' maniji u jipprevjeni li dawn jerġgħu jitfaċċaw.
How has Abilify been studied?
Kif ġie studjat Abilify?
For the treatment of schizophrenia, there were three main short-term studies of Abilify tablets lasting four to six weeks, which involved 1,203 patients and compared Abilify with placebo (a dummy treatment).
Għat- trattament ta 'l- iskizofrenija, twettqu tliet studji ewlenin b' terminu qasir għall- Abilify f' forma ta' pilloli li damu minn erbgħa sa sitt ġimgħat u involvew 1, 203 pazjenti u qabblu Abilify mal- plaċebo (trattament finta).
The effectiveness of Abilify in preventing symptoms from returning was assessed in three studies lasting up to a year, two of which used haloperidol (another antipsychotic medicine) as a comparator.
L- effikaċja ta 'Abilify biex jipprevjeni li s- sintomi jerġgħu jitfaċċaw ġiet valutata fi tliet studi li damu massimu sena, tnejn minnhom użaw haloperidol (mediċina antipsikotika oħra) bħala mediċina tat- tqabbil.
The effectiveness of the solution for injection was compared with placebo over a period of two hours in two studies involving 805 patients with schizophrenia or related conditions who were experiencing symptoms of agitation.
L- effikaċja tas- soluzzoni għal injezzjoni tqabblet mal- plaċebo f' żewġ studji fuq perjodu ta 'sagħtejn li involvew 805 pazjenti skizofreniċi jew b' kundizzjonijiet relatati, b' sintomi ta' aġitazzjoni.
All of the studies measured the change in the patient’ s symptoms using a standard scale for schizophrenia.
It- tliet studji kollha kejlu l- bidla fis- sintomi tal- pazjent bl- użu ta 'skala standard għall - iskizofrenija.
For the treatment of bipolar disorder, there were eight main studies looking at Abilify taken by mouth.
Għat- trattament tad- disturb bipolari, twettqu tmien studji ewlenin li eżaminaw Abilify meta jittieħed mill- ħalq.
There were five short-term studies that compared the effectiveness of Abilify and placebo over three weeks in a total of 1,900 patients.
Twettqu ħames studji b' terminu qasir li qabblu l- effikaċja ta 'Abilify u l- plaċebo fuq perjodu ta' tliet ġimgħat fuq total ta '1, 900 pazjent.
Two of these studies used haloperidol and lithium (another antipsychotic medicine) as comparators and continued for a further nine weeks to look at the maintenance of the effect of the medicines.
Tnejn minn dawn l- istudji użaw haloperidol u l- litju (mediċina antipsikotika oħra) bħala mediċini tat- tqabbil u tkomplew għal disa 'ġimgħat oħra biex jeżaminaw il- manteniment ta' l- effett tal- mediċini.
Another study compared Abilify with haloperidol over 12 weeks in 347 patients, and a further study compared the effectiveness of Abilify and placebo in preventing recurrence in 160 patients whose manic symptoms had already been stabilised using Abilify.
Studju ieħor qabbel Abilify ma 'haloperidol fi 347 pazjent fuq perjodu ta' 12- il ġimgħa u studju ulterjuri qabbel l- effikaċja ta 'Abilify mal- plaċebo biex jipprevjeni li s- sintomi jerġgħu jitfaċċaw f' 160 pazjent li s- sintomi ta' maniji tagħhom ġew diġà stabilizzati bl- użu ta 'Abilify.
The eighth study looked at the effect of adding Abilify or placebo to existing treatment with lithium or valproate (another antipsychotic medicine) in 384 patients.
It- tmien studju eżamina l- effett li Abilify jew il- plaċebo jiżdied mat - trattament attwali bil- litju jew valproate (mediċina antipsikotika oħra) fi 384 pazjent.
The effectiveness of Abilify solution for injection was compared with that of lorazepam (another antipsychotic medicine) and of placebo over a period of two hours in one study involving 301 patients with bipolar disorder who were experiencing symptoms of agitation.
L- effikaċja ta 'Abilify f' forma ta' soluzzjoni għal injezzjoni tqabblet ma 'dik ta' lorazepam (mediċina antipsikotika oħra) u tal- plaċebo fuq perjodu ta 'sagħtejn fi studju wieħed li involva 301 pazjent b' disturb bipolari b' sintomi ta' aġitazzjoni.
All of these studies looked at the change in symptoms using a standard scale for bipolar disorder or at the number of patients who responded to treatment.
Dawn l- istudji kollha eżaminaw il- bidla fis- sintomi bl- użu ta 'skala standard għad- disturb bipolari jew l- għadd ta' pazjenti li rrispondew għat- trattament.
The company also carried out studies looking at the absorption of the orodispersible tablets and oral solution by the body.
Barra minn hekk, il- kumpanija wettqet xi studji li eżaminaw l- assorbiment tal- pilloli orodispersibbli u tas- soluzzjoni orali mill- ġisem.
What benefit has Abilify shown during the studies?
Liema benefiċċji ta 'Abilify intwerew f' dawn l- istudji?
When used to treat schizophrenia, Abilify was more effective than placebo in the short-term studies.
Abilify irriżulta aktar effikaċi mill- plaċebo fit- trattament ta 'l- iskizofrenija fl- istudji b' terminu qasir.
In the long-term studies, Abilify was more effective than placebo, and as effective as haloperidol, after up to a year of treatment.
F' dawk b' terminu twil, Abilify irriżulta aktar effikaċi mill- plaċebo, effikaċi daqs haloperidol, sa massimu ta 'sena wara t- trattament.
In both studies of the solution for injection, patients receiving Abilify at doses of 5.25, 9.75 or 15 mg had a significantly greater reduction in symptoms of agitation than those receiving placebo.
Fiż- żewġ studji tas- soluzzjoni għal injezzjoni, il- pazjenti ttrattati b' Abilify bid- dożi ta '5. 25, 9. 75 jew 15 mg esperjenzaw tnaqqis konsiderevoli fis- sintomi ta' aġitazzjoni milli dawk ittrattati bil- plaċebo.
When used to treat bipolar disorder, Abilify was more effective than placebo at reducing manic symptoms in four of the five short-term studies.
Meta użat għat- trattament tad- disturb bipolari, Abilify irriżulta aktar effikaċi mill- plaċebo biex inaqqas is- sintomi ta 'maniji f' erbgħa fost il- ħames studji b' terminu qasir.
Abilify also had a similar effect to haloperidol and to lithium over three weeks.
Abilify kellu wkoll effett analogu għal dak ta 'haloperidol jew tal- litju fuq perjodu ta' tliet ġimgħat.
This effect was maintained for up to 12 weeks.
Dan l- effett inżamm sa massimu ta '12- il ġimgħa.
Abilify was also more effective than placebo at preventing manic episodes returning in previously treated patients for up to 74 weeks, and when it was used as an add-on to existing treatment.
Abilify irriżulta aktar effikaċi mill- plaċebo biex jipprevjeni li episodji ta 'maniji jerġgħu jitfaċċaw fil- pazjenti preċedentement ittrattati sa massimu ta' 74 ġimgħa u meta ntuża 2/ 3 bħala terapija addizzjonali mat- trattament eżistenti.
Injections of Abilify at doses of 10 or 15 mg were also more effective than placebo in reducing the symptoms of agitation, and were of similar effectiveness to lorazepam.
L- injezzjonijiet ta 'Abilify b' dożi ta' 10 jew 15 mg rriżultaw ukoll aktar effikaċi mill- plaċebo biex inaqqsu s- sintomi ta 'aġitazzjoni u kellhom effikaċja simili għal dik ta' lorazepam.
2/ 3 What is the risk associated with Abilify?
X' inhu r- riskju assoċjat ma 'Abilify?
The most common side effects when taking Abilify by mouth (seen in between 1 and 10 patients in 100) are extrapyramidal disorder (uncontrolled twitching or jerking), akathisia (constant urge to move), tremor (shaking), somnolence (sleepiness), sedation (drowsiness), headache, blurred vision, dyspepsia (heartburn), vomiting, nausea (feeling sick), constipation, salivary hypersecretion (increased production of saliva), fatigue (tiredness), restlessness, insomnia (difficulty sleeping) and anxiety.
L- effetti sekondarji l- aktar komuni b' Abilify meħud mill- ħalq (li dehru f' bejn pazjent 1 u 10 f' 100) huma disturb ekstrapiramidali (ċaqliq spasmodiku bla kontroll), akatiżija (inkapaċità kontinwa li toqgħod mingħajr ma tiċċaqlaq), rogħda, ħedla ta 'l- irqad, sedazzjoni (ħedla), uġigħ ta' ras, vista sfukata, dispepsija (qrusa ta 'l- istonku), remettar, nawżea (dardir), stitikezza, produzzjoni eċċessiva ta' bżieq, għeja, nuqqas ta 'sabar, insonnja (diffikultà biex torqod) u ansjetà.
Akathisia is more common in patients with bipolar disorder than in those with schizophrenia.
L- akatiżija hija iktar komuni mal- pazjent b' disturb bipolari milli f' dawk skizofreniċi.
Between 1 and 10 patients in 100 receiving injections of Abilify experience somnolence, dizziness, headache, akathisia, nausea and vomiting.
Bejn pazjent 1 u 10 fost il- 100 ttrattati bl - injezzjonijiet ta 'Abilify kellhom ħedla ta' l- irqad, sturdament, uġigħ ta 'ras, akatiżija, nawżea u remettar.
For the full list of all side effects reported with Abilify, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati b' Abilify, ara l- Fuljett ta' Tagħrif.
Abilify should not be used in people who may be hypersensitive (allergic) to aripiprazole or any of the other ingredients.
Abilify ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal aripiprazole jew għal xi ingredjenti oħra tiegħu.
Why has Abilify been approved?
Għaliex ġie approvat Abilify?
The Committee for Medicinal Products for Human Use (CHMP) decided that Abilify’ s benefits are greater than its risks for the treatment of schizophrenia and 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.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Abilify huma ogħla mir- riskji tiegħu għat- trattament ta' l- iskizofrenija u tad- disturb bipolari tat- tip I b' episodji ta 'maniji minn moderati għal gravi u għall- prevenzjoni ta' episodji ta 'maniji ġodda fil - pazjenti li għaddew predominantement minn episodji ta' maniji u li dawk irrispondew għat- trattament b' aripiprazole.
It also decided that the benefits of the solution for injection outweighed its risks for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or in patients with manic episodes in bipolar I disorder, when oral therapy is not appropriate.
Il- Kumitat iddeċieda wkoll li l- benefiċċji tas- soluzzjoni għal injezzjoni kienu ogħla mir- riskji għall- kontroll rapidu ta 'l- aġitazzjoni u tad- disturbi fl- imġiba fil- pazjenti skizofreniċi jew bid- disturb bipolari tat- tip I b' episodji ta' maniji, meta t- terapija orali ma tkunx adegwata.
The Committee recommended that Abilify be given marketing authorisation.
Il- Kumitat irrakkomanda li Abilify jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Abilify:
Aktar tagħrif dwar Abilify:
The European Commission granted a marketing authorisation valid throughout the European Union for Abilify to Otsuka Pharmaceutical Europe Ltd. on 4 June 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Abilify lil Otsuka Pharmaceutical Europe Ltd. fl- 4 ta 'Ġunju 2004.
The full EPAR for Abilify can be found here.
L- EPAR sħiħ għal Abilify jista 'jiġi kkonsultat hawn.
Oral use
Użu orali
unit dose perforated blister (alu/ alu)
perforata( alu/ alu) folja ta ’ doża waħda
Tablet
Pillola
unit dose perforated blister (alu/ alu)
perforata( alu/ alu)
EU/ 1/ 04/ 276/ 020
1/ 2 folja ta ’ doża waħda EU/ 1/ 04/ 276/ 020
Orodispersible Tablet
Pilloli li jinħallu fil- ħalq
49 x 1
49 x 1 1 flixkun + 1 tazza +
bottle (PET)
flixkun (PET)
1 bottle + 1 cup + 1 calibrated dropper
1 flixkun + 1 tazza +
1 bottle + 1 cup + 1 calibrated dropper
1 dropper ikkalibrat
Solution for injection
injezzjoni
Intramuscular use
muskoli
1.3 ml
1. 3 ml
ABILIFY 5 mg tablets
ABILIFY 5 mg pilloli
67 mg lactose per tablet
67 mg lactose kull pillola
Tablet Rectangular and blue, engraved with "A-007" and "5" on one side.
Pillola Rettangolari u blu, imnaqqxa b '"A- 007" u "5" fuq naħa waħda.
2 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).
Neuroleptic Malignant Syndrome (NMS):
3 Sindromu Newrolettiku malinn (NMS):
Hypersensitivity: as with other medications hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
4 Sensittività eċċessiva: bħalma jiġri b’ medikazzjonijiet oħra, jistgħu jseħħu reazzjonijiet ta ’ sensittività eċċessiva, ikkaratterizzati minn sintomi ta ’ allerġija, b’ aripiprazole (ara sezzjoni 4. 8).
ABILIFY dose should be doubled when concomitant administration of ABILIFY occurs with carbamazepine.
5 Id- doża ta ’ ABILIFY għandha tiġi rduppjata meta ABILIFY tingħata ma ’ carbamazepine.
5 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*
6 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 *
6 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 7
The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
8 medikament importanti kienu jinkludu ħedla ta 'rqad, telf temporanju ta' koxjenza u sintomi ekstrapiramidali.
8 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.
9 Żieda fil- piż: fi provi kliniċi l- aripiprazole orali ma deherx li jwassal għal żieda fil- piż li hija klinikament relevanti.
9 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:
10 Eliminazzjoni:
10 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).
11 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).
Indigo carmine aluminium lake (E132)
Indigo karminju aluminju aħmar skur (E132)
ABILIFY 10 mg tablets
ABILIFY 10 mg pilloli
62.18 mg lactose per tablet
62. 18 mg lactose kull pillola
Tablet Rectangular and pink, engraved with "A-008" and "10" on one side.
Pillola Rettangolari u roża, imnaqqxa b '"A- 008" u "10" fuq naħa waħda.
13 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).
Neuroleptic Malignant Syndrome (NMS):
15 Sindromu Newrolettiku malinn (NMS):
Hypersensitivity: as with other medications hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
16 Sensittività eċċessiva: bħalma jiġri b’ medikazzjonijiet oħra, jistgħu jseħħu reazzjonijiet ta ’ sensittività eċċessiva, ikkaratterizzati minn sintomi ta ’ allerġija, b’ aripiprazole (ara sezzjoni 4. 8).
15 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.
17 Id- doża ta ’ ABILIFY għandha tiġi rduppjata meta ABILIFY tingħata ma ’ carbamazepine.
16 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*
18 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 *
17 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 19
The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
20 medikament importanti kienu jinkludu ħedla ta 'rqad, telf temporanju ta' koxjenza u sintomi ekstrapiramidali.
19 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.
21 Żieda fil- piż: fi provi kliniċi l- aripiprazole orali ma deherx li jwassal għal żieda fil- piż li hija klinikament relevanti.
20 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:
22 Eliminazzjoni:
21 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).
23 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).
22 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
ABILIFY 15 mg tablets
ABILIFY 15 mg pilloli
57 mg lactose per tablet
57 mg lactose kull pillola
Tablet Round and yellow, engraved with "A-009" and "15" on one side.
Pillola Tonda u safra, imnaqqxa b '"A- 009" u "15" fuq naħa waħda.
24 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).
Neuroleptic Malignant Syndrome (NMS):
27 Sindromu Newrolettiku malinn (NMS):
Cerebrovascular adverse events: in the same trials, cerebrovascular adverse events (e. g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age:
Ġrajjiet avversi ċerebrovaskulari: fl- istess provi, kienu rrapurtati ġrajjiet avversi ċerebrovaskulari (eż. puplesija, attakk għaddieni iskemiku), inklużi uħud fatali, f' pazjenti (età medja:
84 years; range:
84 sena; medda:
78-88 years).
78 - 88 sena).
Overall, 1.3% of aripiprazole-treated patients reported cerebrovascular adverse events compared with 0.6% of placebo-treated patients in these trials.
Bħala total, 1. 3% ta 'pazjenti kkurati bl- aripiprazole irrapurtaw ġrajjiet avversi ċerebrovaskulari mqabbla ma' 0. 6% ta 'pazjenti kkurati bil- plaċebo f' dawn il- provi.
This difference was not statistically significant.
Din id- differenza ma kenitx statistikament sinifkanti.
However, in one of these trials, a fixed-dose trial, there was a significant dose response relationship for cerebrovascular adverse events in patients treated with aripiprazole.
Madankollu, f' waħda minn dawn il- provi, prova b' doża fissa, kien hemm konnessjoni sinifikanti ta 'rispons għad- droga għal ġrajjiet avversi ċerebrovaskulari f' pazjenti kkurati bl- aripiprazole.
ABILIFY is not approved for the treatment of dementia-related psychosis.
ABILIFY mhux approvat għall- kura ta 'psikosi relatata ma' dimenzja.
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.
Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
Fatturi ta 'riskju li jistgħu jippredisponu pazjenti għal kumplikazzjonijiet severi jinkludu obesità u passat ta' dijabete fil- familja.
In clinical trials with aripiprazole, there were no significant differences in the incidence rates of hyperglycaemia-related adverse events (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
Fi provi kliniċi bl- aripiprazole, ma kienx hemm differenzi sinifikanti fir- rati ta 'inċidenza ta' ġrajjiet avversi assoċjati ma 'ipergliċemija (inkluż id- dijabete) jew fil- valuri tal- laboratorju ta' gliċemija annormali mqabbla ma 'plaċebo.
Precise risk estimates for hyperglycaemia-related adverse events in patients treated with ABILIFY and with other atypical antipsychotic agents are not available to allow direct comparisons.
Estimi eżatti ta 'riskju għal ġrajjiet avversi assoċjati ma' ipergliċemija f' pazjenti kkurati b' ABILIFY u b' aġenti antipsikotiċi oħra mhux tipiċi mhumix disponibbli sabiex jiġu mqabbla.
Patients treated with any antipsychotic agents, including ABILIFY, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Pazjenti kkurati b' aġenti antipsikotiċi, inkluż ABILIFY, għandhom ikunu osservati għal sinjali u sintomi ta 'ipergliċemija (bħal polydipsia, polyuria, polyphagia u debbulizza) u pazjenti bid- dijabete mellitus jew b' fatturi ta' riskju għal dijabete mellitus għandhom ikunu mmonitorjati regolarment għal aggravar fil- kontroll tal- glucose.
Weight gain: weight gain is commonly seen in schizophrenic and bipolar mania patients due to co- morbidities, use of antipsychotics known to cause weight gain, poorly managed life-style, and might lead to severe complications.
Żjieda fil- piż: hu komuni li jkun hemm żjieda fil- piż ta 'pazjenti skiżofreniċi u pazjenti b’ mania bipolari minħabba co- morbidities, l- użu ta' antipsikotiċi magħrufa li jikkawżaw żjieda fil- piż, immaniġjar ħażin ta 'stil ta' ħajja, u jista 'jagħti lok għal kumplikazzjonijiet gravi.
Weight gain has been reported post-marketing among patients prescribed ABILIFY.
Ġiet irrapurtata żjieda fil- piż wara l- 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.
Meta jkun hemm, is- soltu tkun f' dawk b' fatturi ta 'riskju sinifikanti bħal passat ta' dijabete, disturb tat- tirojde jew adenoma tal- glandola pitwitarja.
In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain (see section 5.1).
Fi provi kliniċi aripiprazole ma deherx li jwassal għal żieda fil- piż klinikament relevanti (ara sezzjoni 5. 1).
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.
Aripiprazole and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.
Aripiprazole u drogi antipsikotiċi oħra għandhom jintużaw b' kawtela fuq pazjenti b' riskju ta 'pnewmonja tan- nifs.
Lactose: patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Lactose: pazjenti bi problemi rari ereditarji ta 'intolleranza għall- galactose, in- nuqqas ta' lapp lactase jew assorbiment ħażin ta 'glucose- galactose ma għandhomx jieħdu dan il- prodott mediċinali.
Hypersensitivity: as with other medications hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
28 Sensittività eċċessiva: bħalma jiġri b’ medikazzjonijiet oħra, jistgħu jseħħu reazzjonijiet ta ’ sensittività eċċessiva, ikkaratterizzati minn sintomi ta ’ allerġija, b’ aripiprazole (ara sezzjoni 4. 8).
26 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
Due to its α 1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents.
Minħabba li jinibixxi ir- reċettur α1- adrenerġiku, aripiprazole jista ’ jkabbar l- effett ta ’ xi mediċini tal - pressjoni.
Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is taken in combination with alcohol or other CNS medicinal products with overlapping undesirable effects such as sedation (see section 4.8).
Meta wieħed jikkunsidra l- effetti primarji ta 'l - aripiprazolefuq is- sistema nervuża ċentrali, għandha tintuża kawtela meta jittieħed l- aripiprazole flimkien ma ’ l- alkoħol jew ma ’ mediċini oħra li għandhom effett fuq is- sistema nervuża ċentrali u li għandhom effetti mhux mixtieqa li jixbħu lil dawk ta ’ aripiprazole, bħal sedazzjoni (ara taqsima 4. 8).
If aripiprazole is administered concomitantly with medicines known to cause QT prolongation or electrolyte imbalance, caution should be used.
Jekk l- aripiprazole ikun mogħti b' mod konkomitanti ma 'mediċini magħrufa li jikkawżaw tkarkir ta' QT jew żbillanċ elettrolitiku, għandha tintuża kawtela.
Potential for other medicinal products to affect ABILIFY:
Xi mediċini oħra li jistgħu jaffettwaw lil ABILIFY:
A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
Imblokkatur ta ’ l- aċidu fl- istonku, l- antagonista ta ’ l- H2 fomatidine, inaqqas ir- rata li biha jiġi assorbit aripiprazole, iżda dan l- effett m’ huwiex meqjus bħala wieħed klinikament relevanti.
Aripiprazole is metabolised by multiple pathways involving the CYP2D6 and CYP3A4 enzymes but not CYP1A enzymes.
Aripiprazole jiġi metabolizzat b’ diversi sistemi li jirrikjedu l- enżimi CYP2D6 u CYP3A4 iżda mhux l - enżimi CYP1A.
Thus, no dosage adjustment is required for smokers.
Għalhekk m’ hemmx bżonn aġġustament tad- doża f’ dawk li jpejpu.
In a clinical trial in healthy subjects, a potent inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107%, while Cmax was unchanged.
Fi studju kliniku f’ pazjenti b’ saħħithom, inibitur potenti tas- CYP2D6 (quinidine) żied l- AUC ta ’ aripiprazole b ’ 107% waqt li Cmax ma tbiddilx.
The AUC and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32% and 47%.
L- AUC u Cmax ta ’ dehydro- aripiprazole, is- sustanza metabolika attiva, tnaqqsu bejn 32% u 47%.
ABILIFY dose should be reduced to approximately one-half of its prescribed dose when concomitant administration of ABILIFY with quinidine occurs.
Id- doża ta ’ ABILIFY għandha tinaqqas għal bejn wieħed u ieħor nofs id- doża preskritta meta ABILIFY jingħata ma ’ quinidine.
Other potent inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reductions should therefore be applied.
Inibituri potenti oħra ta ’ CYP2D6, bħal fluoxetine u paroxetine jista jkun li jkollhom effetti simili u tnaqqis simili tad- doża għandu għalhekk jiġi applikat.
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 Cmax ta ’ aripiprazole b’ 63% u 37% rispettivament.
The AUC and Cmax of dehydro-aripiprazole increased by 77% and 43%, respectively.
L- AUC u Cmax ta ’ dehydro- aripiprazole żdiedu b ’ 77% u 43% rispettivament.
In CYP2D6 poor metabolisers, concomitant use of potent inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.
Fin- nies li jimmetabolizzaw is- CYP2D6 bil- mod, użu konkomitanti ta’ inibituri potenti ta ’ CYP3A4 jistgħu jirriżultaw f’ konċentrazzjoni ogħla fil- plażma ta ’ aripiprazole, meta mqabbel mal- livell fin- nies li jimmetabolizzaw is- CYP2D6 b’ mod jgħaġġel.
When considering concomitant administration of ketoconazole or other potent CYP3A4 inhibitors with ABILIFY, potential benefits should outweigh the potential risks to the patient.
Meta wieħed qiegħed jaħseb li jagħti ABILIFY ma ’ ketoconazole jew inibituri potenti oħra ta ’ CYP3A4, wieħed irid jiżgura ruħu li ċ- ċans li l- pazjent imur aħjar fuq ABILIFY huwa ikbar miċ- ċans li dan il- pazjent jiżviluppa effetti mhux mixtieqa.
When concomitant administration of ketoconozole with ABILIFY occurs, ABILIFY dose should be reduced to approximately one-half of its prescribed dose.
Meta wieħed jagħti ketoconazole ma ’ ABILIFY, id- doża ta ’ ABILIFY għandha titnaqqas għal bejn wieħed u ieħor nofs id- doża preskritta.
Other potent inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors, may be expected to have similar effects and similar dose reductions should therefore be applied.
Inibituri potenti oħra ta ’ CYP3A4, bħal itraconazole u inibituri tal- protease ta ’ l- HIV li jistgħu jkunu mistennija li jkollhom effetti simili u għalhekk tnaqqis simili tad- doża, għandu jiġi applikat.
Upon discontinuation of the CYP2D6 or 3A4 inhibitor, the dosage of ABILIFY should be increased to the level prior to the initiation of the concomitant therapy.
Meta l- inibitur tas- CYP2D6 jew 3A4 jitwaqqaf, id- doża ta ’ ABILIFY għandha tiżdied sal- livell li kien qed jingħata qabel ma nbdiet it- terapija b’ iktar minn mediċina waħda.
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.
Following concomitant administration of carbamazepine, a potent inducer of CYP3A4, the geometric means of Cmax and AUC for aripiprazole were 68% and 73% lower, respectively, compared to when aripiprazole (30 mg) was administered alone.
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.
Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
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.
29 Id- doża ta ’ ABILIFY għandha tiġi rduppjata meta ABILIFY tingħata ma ’ carbamazepine.
Other potent inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St.
Sustanzi oħra li jistimolaw is- CYP3A4 b’ mod qawwi (bħal rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine u ipericum (St.
John's Wort) may be expected to have similar effects and similar dose increases should therefore be applied.
John’ s Wort)) huma mistennija li jkollhom effetti simili, u għalhekk żidiet simili tad- doża għandhom jiġu applikati.
Upon discontinuation of potent CYP3A4 inducers, the dosage of ABILIFY should be reduced to the recommended dose.
Meta jitwaqqfu dawn is- sustanzi li jistimolaw is- CYP3A4 b’ mod qawwi, id- doża ta ’ ABILIFY għandha titnaqqas sad- doża rakkomandata.
27 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.
Potential for ABILIFY to affect other medicinal products:
Kif ABILIFY jista ’ jaffettwa mediċini oħra:
In clinical studies, 10-30 mg/ day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/ 3-methoxymorphinan ratio), 2C9 (warfarin), 2C19 (omeprazole), and 3A4 (dextromethorphan).
Fi studji kliniċi, dożi t’ aripiprazole ta ’ 10- 30 mg/ jum ma kellhom l- ebda effett ta ’ importanza fuq il - metaboliżmu tas- sustanzi li jaħdmu fuqhom is- CYP2D6 (dextromethorphan/ 3- methoxymorphinan ratio), 2C9 (warfarin), 2C19 (omeprazole), u 3A4 (dextromethorphan).
Additionally, aripiprazole and dehydro-aripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro.
Ukoll, aripiprazole u dehydro - aripiprazole ma wrewx li jistgħu ibiddlu il- metaboliżmu li jiġi effettwat mis- CYP1A2 fi studji in vitro.
Thus, aripiprazole is unlikely to cause clinically important medicinal product interactions mediated by these enzymes.
Għaldaqstant m’ huwiex probabbli li aripiprazole jaġixxi b’ mod ħażin ma ’ dawk il- prodotti mediċinali li jiġu metabolizzati b’ dawn l- enżimi.
When aripiprazole was administered concomitantly with either valproate or lithium, there was no clinically important change in valproate or lithium concentrations.
Meta l- aripiprazole ingħatat b’ mod konkomitanti mal- valproate jew litju, ma kien hemm l- ebda bidla klinikament importanti fil- konċentrazzjonijiet ta 'valproate jew litju.
4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ
There are no adequate and well-controlled trials of aripiprazole in pregnant women.
Ma sarux studji apposta u kkontrollati tajjeb, ta 'l- aripiprazole fin- nisa tqal.
Animal studies could not exclude potential developmental toxicity (see section 5.3).
Studji fuq l- annimali ma setgħux jeskludu il- potenzjal ta ’ tossiċità fl- iżvilupp (ara sezzjoni 5. 3).
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with aripiprazole.
Il- pazjenti għandhom jiġu mgħarrfin biex jgħidu lit- tabib tagħhom jekk joħorġu tqal jew għandhom ħsieb li joħorġu tqal waqt it - trattament b ’ aripipirazole.
Due to insufficient safety information in humans and concerns raised by animal reproductive studies, this medicinal product should not be used in pregnancy unless the expected benefit clearly justifies the potential risk to the foetus.
Minħabba n- nuqqas ta ’ informazzjoni fuq is- sigurta` fil- bnedmin u mit - tħassib imqajjem minn studju fuq ir- riproduzzjoni ta ’ l- annimali, dan il- prodott mediċinali m’ għandux jintuża fit- tqala jekk il- benefiċċju mistenni ma jiġġustifikax b’ mod ċar ir- riskju li jista ’ potenzjalment ikun hemm għall- fetu.
Aripiprazole was excreted in the milk of treated rats during lactation.
Aripiprazole tneħħa fil- ħalib tal- ġrieden li ngħataw il- mediċina waqt li qegħdin ireddgħu.
It is not known whether aripiprazole is excreted in human milk.
Għadna ma nafux jekk aripiprazole jitneħħiex fil- ħalib tal- bniedem.
Patients should be advised not to breast feed if they are taking aripiprazole.
Il- pazjenti għandhom ikunu avżati li ma għandhomx ireddgħu jekk qegħdin jieħdu aripiprazole.
No studies on the effect on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
However, as with other antipsychotics, patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that aripiprazole does not affect them adversely.
Madankollu, l- istess kif ma 'mediċini antipsikotiċi oħra, il- pazjenti għandhom ikunu avżati dwar l- operat ta' magni perikolużi, inkluż is- sewqan tal- karozzi, sakemm jaċċertaw ruħhom li l- aripiprażole m’ għandu l- ebda effett avvers fuqhom.
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 (≥ 1/ 100) mill- placebo, jew ġew identifikati bħala reazzjonijiet avversi possibilment relevanti klinikament (*):
The frequency listed below is defined using the following convention: common (> 1/ 100 ,< 1/10) and uncommon (> 1/1 ,000, < 1/100).
Il- frekwenza kif imniżżla hawn taħt hi definita skond din il- konvenzjoni: komuni (> 1/ 100, < 1/ 10) u mhux komuni (> 1/ 1, 000, < 1/ 100).