qanastek/EMEA-V3 huggingface dataset:
91 observed in rats at doses resulting in subtherapeutic exposures (based on AUC) and in rabbits at doses resulting in exposures 3 and 11 times the mean steady-state AUC at the maximum recommended clinical dose.
Effett tossiku fuq l- iżvilupp, li jinkludu, tardjar ta ’ l - ossifikazzjoni tal- fetu skond id- doża u effetti teratoġeniċi possibli ġew osservati f' firien b’ dożi li jirriżultaw f’ espożizzjonijiet taħt il- livelli terapewtiċi (ibbażati fuq l- AUC) u fi fniek b’ dożi li jirriżultaw f’ espożizzjonijiet ta ’ 3 u 11- il darba iktar mill- medja ta ’ l- AUC fi stat stabbli fid- doża massima klinika rakkomandata.
Disodium edetate Fructose Glycerin Lactic acid Methyl parahydroxybenzoate (E218) Propylene glycol Propyl parahydroxybenzoate (E216) Sodium hydroxide Sucrose Purified water
Disodium edetate Fructose Glycerin Lactic acid Methyl parahydroxybenzoate (E218) Propylene glycol Propyl parahydroxybenzoate (E216) Sodium hydroxide Sucrose Ilma ppurifikat
Natural orange cream with other natural flavours
Krema naturali tal- larinġ ma 'togħmit naturali oħrajn
The oral solution should not be diluted with other liquids or mixed with any food prior to administration.
Is- soluzzjoni orali ma għandhiex tiġi mħallta ma 'likwidi oħrajn jew ma' kwalunkwe ikel qabel tingħata.
6.3 Shelf life
96 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
3 years After first opening:
3 snin Wara li jinfetaħ għall- ewwel darba:
6 months.
6 xhur.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali ma jeħtieġx kundizzjonijiet speċjali għall- ħażna.
PET-bottles with polypropylene child-resistant closure containing 50, 150 or 480 ml per bottle.
Flixken tal- PET b' tapp tal- polypropylene u li ma jinfetaħx mit- tfal li fih 50, 150 or 480 ml kull flixkun.
Each carton contains 1 bottle and both a calibrated polypropylene measuring cup and a calibrated polypropylene low-density polyethylene dropper.
Kull kartuna fiha flixkun wieħed kif ukoll tazza kkalibrata tal- polypropylene għall- kejl u dropper ikkalibrat tal- polypropylene maghmul minn polyethylene b' densita 'baxxa.
ABILIFY 7.5 mg/ ml solution for injection
ABILIFY 7. 5 mg/ ml soluzzjoni għall- injezzjoni
Each ml contains 7.5 mg of aripiprazole.
Kull ml fih 7. 5 mg ta 'aripiprazole.
A vial contains 9.75 mg aripiprazole.
Kunjett fih 9. 75 mg ta 'aripiprazole.
Solution for injection Clear, colourless, aqueous solution.
Soluzzjoni għall- injezzjoni Soluzzjoni milwiema, ċara u bla kulur.
ABILIFY solution for injection is indicated 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.
ABILIFY soluzzjoni għall- injezzjoni hi indikata għall- kontroll rapidu ta 'aġitazzjoni u mġiba disturbata f' pazjenti bi skiżofrenja jew f’ pazjenti b’ episodji manijaċi f’ Disturb Bipolari I, meta terapija orali ma tkunx addattata.
Treatment with aripiprazole solution for injection should be discontinued as soon as clinically appropriate and the use of oral aripiprazole should be initiated.
Il- kura bis- soluzzjoni aripiprazole għall- injezzjoni għandha titwaqqaf hekk kif ikun xieraq klinikament u jinbeda l- użu ta 'aripiprazole orali.
For intramuscular use.
Għal użu ġol- muskolu.
To enhance absorption and minimise variability, injection into the deltoid or deep within the gluteus maximus muscle, avoiding adipose regions, is recommended.
Biex jiżdied l- assorbiment u titnaqqas il- varjabilità, hi rrakkomandata injezzjoni fid- deltoid jew fond fil- muskolu gluteus maximus, waqt li tevita l- partijiet mimlijin xaħam.
ABILIFY solution for injection should not be administered intravenously or subcutaneously.
ABILIFY soluzzjoni għall- injezzjoni m' għandhiex tkun amministrata minn ġol- vini jew minn taħt il - ġilda.
ABILIFY solution for injection is ready to use and intended for short-term use only (see section 5.1).
ABILIFY soluzzjoni għall- injezzjoni hi lesta biex tintuża u intenzjonata għal użu fuq medda qasira ta 'żmien biss (ara taqsima section 5. 1).
The recommended initial dose for aripiprazole solution for injection is 9.75 mg (1.3 ml), administered as a single intramuscular injection.
Id- doża tal- bidu rakkomandata għas- soluzzjoni aripiprazole għall- injezzjoni hi 9. 75 mg (1. 3 ml), mogħtija bħala injezzjoni waħda minn ġol- muskolu.
The effective dose range of aripiprazole solution for injection is 5.25-15 mg as a single injection.
Il- medda effettiva ta 'doża ta' soluzzjoni aripiprazole għall- injezzjoni hi 5. 25- 15 mg bħala injezzjoni waħda.
A lower dose of 5.25 mg (0.7 ml) may be given, on the basis of individual clinical status, which should also include consideration of medicinal products already administered either for maintenance or acute treatment (see section 4.5).
Doża aktar baxxa ta '5. 25 mg (0. 7 ml) tista' tingħata, fuq il- bażi tal- qagħda klinika individwali, li għandha wkoll tinkludi konsiderazzjoni tal- prodotti mediċinali li diġa qed jittieħdu jew għal manteniment jew għal kura intensa (ara taqsima 4. 5).
A second injection may be administered 2 hours after the first injection, on the basis of individual clinical status and no more than three injections should be given in any 24-hour period.
Tista 'tingħata injezzjoni oħra sagħtejn wara l- ewwel injezzjoni, fuq il- bażi tal- qagħda klinika individwali u m' għandhomx jingħataw aktar minn tlett injezzjonijiet f' perjodu ta' 24 siegħa.
The maximum daily dose of aripiprazole is 30 mg (including all formulations of aripiprazole).
Id- doża massima ta 'aripiprazole li tista' tingħata kuljum hi 30 mg (li tinkludi kull formulazzjoni ta 'aripiprazole).
If continued treatment is indicated with oral aripiprazole, see the Summary of Product Characteristics for ABILIFY tablets, ABILIFY orodispersible tablets, or ABILIFY oral solution.
Jekk hemm indikazzjoni li se titkompla l- kura b' aripiprazole orali, ara s- Sommarju ta 'Karatteristiċi tal - Prodott għal pilloli ABILIFY, pilloli orodispersible ABILIFY, jew soluzzjoni orali ABILIFY.
Children and adolescents: there is no experience in children and adolescents under 18 years of age.
Tfal u adoloxxenti: m' hemmx esperjenza dwar l- użu fit- tfal u adolexxenti taħt it- 18- il sena.
Patients with hepatic impairment: no dosage adjustment is required for patients with mild to moderate hepatic impairment.
98 Pazjenti b’ indeboliment epatiku: m’ hemmx bżonn ta 'aġġustament tad- doża f’ pazjenti b’ mard tal - fwied ħafif sa moderat.
In patients with severe hepatic impairment, the data available are insufficient to
F’ pazjenti b’ indeboliment tal- fwied sever, l- informazzjoni disponibbli hija insuffiċenti biex tistabbilixxi rakkomandazzjonijiet.
In these patients dosing should be managed cautiously.
F’ dawn il- pazjenti d- doża għanda tiġi kkontrollata b’ kawtela.
Elderly: the effectiveness of ABILIFY solution for injection in patients who are 65 years of age or older has not been established.
Anzjani: l- effettività ta ’ ABILIFY għadha ma ġietx stabbilita f’ pazjenti li għandhom 65 sena jew aktar.
The efficacy of aripiprazole solution for injection in patients with agitation and disturbed behaviours has not been established related to conditions other than schizophrenia and manic episodes in Bipolar I Disorder.
L- effikaċja ta 'soluzzjoni aripiprazole għall- injezzjoni f' pazjenti b' aġitazzjoni u mġieba disturbata ma kenitx stabbilita rigward kundizzjonijiet għajr skiżofrenja u episodji manijaċi f’ Distrub Bipolari I.
Simultaneous administration of injectable antipsychotics and parenteral benzodiazepine may be associated with excessive sedation and cardiorespiratory depression.
Amministrazzjoni simultanja ta 'antipsikotiċi li jistgħu jkunu injettati u parenteral benzodiazepine jistgħu jkunu assoċjati ma' sedazzjoni eċċessiva u dipressjoni kardjorespiratorja.
If parenteral benzodiazepine therapy is deemed necessary in addition to aripiprazole solution for injection, patients should be monitored for excessive sedation and for orthostatic hypotension (see section 4.5).
Jekk il- kura bil - parenteral benzodiazepine titqies bħala neċessarja flimkien ma 'soluzzjoni aripiprazole għall - injezzjoni, il- pazjenti għandhom ikunu mmonitorjati għal sedazzjoni eċċessiva u għal pressjoni ortostatika baxxa ħafna (ara taqsima 4. 5).
Patients receiving aripiprazole solution for injection should be observed for orthostatic hypotension.
Pazjenti li qed jieħdu soluzzjoni aripiprazole għall- injezzjoni għandhom ikunu osservati għal pressjoni ortostatika baxxa ħafna.
Blood pressure, pulse, respiratory rate and level of consciousness should be monitored regularly.
Il- pressjoni tad- demm, il- polz, ir- rata ta 'respirazzjoni u l- livell ta' koxjenza għandhom ikunu mmonitorjati regolarment.
The safety and efficacy of aripiprazole solution for injection has not been evaluated in patients with alcohol or medicinal product intoxication (either with prescribed or illicit medicinal products).
Is- sigurtà u l- effikaċja ta 'soluzzjoni aripiprazole għall- injezzjoni ma gietx imkejla f' pazjenti b' avvelenar minn prodotti mediċinali jew alkoholiċi (jew bi prodotti mediċinali preskritti jew illeċiti).
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- burdata u f' xi każijiet ġiet irrapurtata hekk kif bdiet jew inbidlet il- kura bl- antipsikotiċi, inkluża l- kura bl- aripiprazole (ara taqsima 4. 8).
Cardiovascular disorders:
99 Disturbi kardjovaskulari:
Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or
L- aripiprazole għandu jintuża b' kawtela f' pazjenti magħrufin li għandhom mard kardjovaskulari (passat ta 'infart mijokardjali jew mard iskemiku tal- qalb, attakk tal- qalb, jew anormalitajiet ta' trasmissjoni), mard ċerebrovaskulari, kundizzjonijiet li jippredisponu lill- pazjent għall- pressjoni baxxa ħafna (deidratazzjoni, ipovolemja, u kura b' medikazzjonijiet tal- pressjoni) jew pressjoni għolja, inkluża dik mgħaġġla jew mhux kontrollabbli.
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 kurati bl- aripiprazole kellhom riskju ogħla ta' mewt imqabbla mal- plaċebo.
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,
96 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 b’ manija 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 il- bejgħ fost pazjenti preskritti l- ABILIFY.
The administration of lorazepam solution for injection had no effect on the pharmacokinetics of aripiprazole solution for injection when administered concomitantly.
It- teħid ta 'soluzzjoni għall- injezzjoni lorazepam m' għandha l- ebda effett fuq il- farmakokinetiċi ta' soluzzjoni għall- injezzjoni aripiprazole meta meħudin b' mod konkomitanti.
However, in a single-dose, intramuscular study of aripiprazole (dose 15 mg) in healthy subjects, administered simultaneously with intramuscular lorazepam (dose 2 mg), the intensity of sedation was greater with the combination as compared to that observed with aripiprazole alone.
Madankollu, fi studju b' doża waħda ta 'aripiprazole (doża 15 mg) ġol- muskolu, f' nies b' saħħithom, mogħtija simultanjament ma' lorazepam (doża 2 mg) ġol- muskolu, l- intensità tas- sedazzjoni kienet akbar bit- tnejn flimkien meta mqabbla ma 'dik osservata mill- aripiprazole waħdu.
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,
97 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.
The administration of aripiprazole solution for injection had no effect on the pharmacokinetics of lorazepam solution for injection when administered concomitantly.
It- teħid ta 'soluzzjoni aripiprazole għall- injezzjoni ma kellha l- ebda effett fuq il- farmakokinetiċi ta' soluzzjoni lorazepam għall- injezzjoni meta meħudin b' mod konkomitanti.
However, in a single-dose, intramuscular study of aripiprazole (dose 15 mg) in healthy subjects, administered simultaneously with intramuscular lorazepam (dose 2 mg), the orthostatic hypotension observed was greater with the combination as compared to that observed with lorazepam alone.
Madankollu, fi studju b' doża waħda ta 'aripiprazole (doża 15 mg) ġol- muskolu, f' nies b' saħħithom, mogħtija simultanjament ma' lorazepam (doża 2 mg) ġol- muskolu, l- intensità tas- sedazzjoni kienet akbar bit- tnejn flimkien meta mqabbla ma 'dik osservata mill- aripiprazole waħdu.
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 taqsima 5. 3).
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.
102 jintuża fit- tqala jekk il- benefiċċju mistenni ma jiġġustifikax b’ mod ċar ir- riskju li jista ’ potenzjalment ikun hemm għall- fetu.
98 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*) in clinical trials with aripiprazole solution for injection (see section 5.1):
Dawn l- effetti mhux mixtieqa ġraw iktar spiss minn (≥ 1/ 100) meta mqabbla mal- plaċebo, jew ġew identifikati bħala reazzjonijiet possibbli medikament relevanti (*) fi provi kliniċi b' soluzzjoni ta 'aripiprazole għall- injezzjoni (ara taqsima 5. 1):
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).
Cardiac disorders Uncommon: tachycardia* Nervous system disorders Common: somnolence, dizziness, headache, akathisia Gastrointestinal disorders Common: nausea, vomiting Uncommon: dry mouth* Vascular disorders Uncommon: orthostatic hypotension*, increased diastolic blood pressure* General disorders and administration site conditions Uncommon: fatigue*
Disturbi fil- qalb Mhux komuni: takikardja * Disturbi fis- sistema nervuża Komuni: ħedla ta 'rqad, sturdament, uġigħ ta' ras, akatiżja Disturbi gastro- intestinali Komuni: nawsja, remettar Mhux komuni: ħalq xott * Disturbi vaskulari Mhux komuni: pressjoni baxxa ħafna ortostatika *, pressjoni dijastolika tad- demm miżjuda * Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Mhux komuni: għejja *
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*) in clinical trials with oral formulations of aripiprazole (see section 5.1):
Dawn l- effetti mhux mixtieqa ġraw iktar spiss minn (≥ 1/ 100) meta mqabbla mal- plaċebo, jew ġew identifikati bħala reazzjonijiet possibbli medikament relevanti (*) fi provi kliniċi b' formulazzjonijiet orali ta 'aripiprazole (ara taqsima 5. 1):
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*
Komuni: irrekwitezza, insomnja, ansjetà Mhux komuni: dipressjoni *
Extrapyramidal symptoms (EPS):
103 Sintomi ekstrapiramidali (EPS):
Schizophrenia - in a long term 52-week controlled trial, aripiprazole-treated patients had an overall-lower incidence (25.8%) of EPS including parkinsonism, akathisia, dystonia and dyskinesia compared with those treated with haloperidol (57.3%).
Skizofrenija: waqt studju ikkontrollat fit- tul ta ’ 52 ġimgħa, pazjenti kkurati b’ aripiprazole kellhom tnaqqis totali (25. 8%) ta ’ EPS li jinkludu parkinsoniżmu, akatiżja u diskineżja, meta mqabbla ma ’ dawk ikkurati b’ haloperidol (57. 3%).
Manic episodes in Bipolar I Disorder - in a 12-week controlled trial, the incidence of EPS was 23.5% for aripiprazole-treated patients and 53.3% for haloperidol-treated patients.
Episodji manijaċi f’ Disturb Bipolari I – fi prova kkontrollata ta ’ 12- il ġimgħa, l- inċidenza ta ’ EPS kienet 23. 5% għal pazjenti kkurati b’ aripiprazole u 53. 3% għal pazjenti kkurati b’ haloperidol.
In another 12-week trial, the incidence of EPS was 26.6% for patients treated with aripiprazole and 17.6% for those treated with lithium.
Fi prova ta ’ 12- il ġimgħa oħra, l- inċidenza ta ’ EPS kienet 26. 6% għal pazjenti kkurati b’ aripiprazole u 17. 6% għal dawk ikkurati b’ Litju.
In the long term 26-week maintenance phase of a placebo-controlled trial, the incidence of EPS was 18.2% for aripiprazole-treated patients and 15.7% for placebo-treated patients.
Fil- fażi ta ’ manteniment ta ’ 26 ġimgħa ta ’ prova kkontrollata bi plaċebo, l- inċidenza ta ’ EPS kienet ta ’ 18. 2% għal pazjenti kkurati b’ aripiprazole u 15. 7% għal pazjenti kkurati bi plaċebo.
In placebo-controlled trials, the incidence of akathisia in bipolar patients was 12.1% with aripiprazole and 3.2% with placebo.
Fi provi kkontrollati bi plaċebo, l- inċidenza ta ’ akatisja f’ pazjenti bipolari kienet ta ’ 12. 1% b’ aripiprazole u 3. 2% bi plaċebo.
In schizophrenia patients the incidence of akathisia was 6.2% with aripiprazole and 3.0% with placebo.
F’ pazjenti bi skizofrenija, l- inċidenza ta ’ akatisja kienet 6. 2% b ’ aripiprazole u 3. 0% bi plaċebo.
99 Comparisons between aripiprazole and placebo in the proportions of patients experiencing potentially clinically significant changes in routine laboratory parameters revealed no medically important differences.
Meta wieħed iqabbel aripiprazole mal- plaċebo fuq il- proporzjon tal- pazjenti li wrew tibdil klinikament importanti fit- testijiet tal- laboratorju, ma dehret l- ebda differenza importanti klinikament.
Elevations of CPK (Creatine Phosphokinase), generally transient and asymptomatic, were observed in 3.5% of aripiprazole treated patients as compared to 2.0% of patients who received placebo.
Elevazzjonijiet ta ’ CPK (Kreatina Fosfokinejż), ġeneralment li tgħaddi u asintomatika, kienu osservati fi 3. 5% tal- pazjenti ikkurati b’ aripiprazole meta mqabbla ma ’ 2. 0% tal- pazjenti li rċevew plaċebo.
The following adverse events have been reported during post-marketing surveillance.
Il- ġrajjiet avversi li ġejjin ukoll ġew irrappurtati f' każijiet rari ħafna waqt sorveljanza wara l- bejgħ.
The frequency of these events is considered not known (cannot be estimated from the available data).
Il - frekwenza ta ’ dawn l- episodji għadha mhux magħrufa (ma tistax tiġi stmata mit- tagħrif disponibbli):
Musculoskeletal and connective tissue disorders:
Disturbi muskolu- skeltrali u
rhabdomyolysis, myalgia, stiffness
tal- connective tissue u ta 'l - għadam:
N05AX12
N05 AX12
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 hi medjata bejn taħlita ta' agoniżmu parzjali tar- reċetturi dopamina D2 u serotonina 5HT1a, u antagoniżmu tar- reċetturi serotonina 5HT2.
Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic hypoactivity.
Aripiprazole wriet li tnaqqas l- attività f’ annimali li juru attività żejda tad- dopamina u żżid l- attività f’ annimali li juru nuqqas ta ’ attività tad- dopamina.
Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and moderate affinity for dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and histamine H1 receptors.
L- aripiprazole wera affinità ta 'rabta qawwija in vitro għar- reċetturi tad- dopamina D2 u D3, tas- serotonina 5HT1a u 5HT21, u b’ mod inqas qawwi mar- reċetturi tad- dopamina D4, tas- serotonina 5HT2c u 5HT7, α1- adrenerġiki u H1 istamina.
101 Further information on clinical trials:
Iżjed tagħrif fuq provi kliniċi:
Agitation in schizophrenia and Bipolar I Disorder with aripiprazole solution for injection:
Aġitazzjoni fi skizofrenja u f’ Disturb Bipolari I b' soluzzjoni ta ’ aripiprazole għall- injezzjoni:
In two short- term (24-hour) placebo-controlled trials involving 554 schizophrenic patients presenting with agitation and disturbed behaviours, aripiprazole solution for injection was associated with statistically significant greater improvements in agitation/ behavioural symptoms compared to placebo and was similar to haloperidol.
F' żewġ provi fuq medda qasira (24 siegħa) ikkontollati minn plaċebo li fihom kienu involuti 554 pazjent skiżofreniku li ppreżentaw mġieba ta 'aġitazzjoni u disturbata, soluzzjoni aripiprazole għall- injezzjoni kienet assoċjata ma' titjib statistikament sinifikanti akbar fis- sintomi ta 'aġitazzjoni u ta' mġieba mqabbla ma 'plaċebo u kienu l- istess għal haloperidol.
In one short-term (24-hour) placebo-controlled trial involving 291 patients with bipolar disorder presenting with agitation and disturbed behaviours, aripiprazole solution for injection was associated with statistically significant greater improvements in agitation/ behavioural symptoms compared to placebo and was similar to the reference arm lorazepam.
Fi prova qasira (24 siegħa) kkontrollata bi plaċebo li involviet 291 pazjent b’ disturb bipolari preżenti b’ aġitazzjoni u b’ imġiba disturbata, soluzzjoni ta ’ aripiprazole għall- injezzjoni ġiet assoċjata ma ’ titjib statistikament ferm ikbar f’ sintomi ta ’ aġitazzjoni/ imġiba meta mqabbla ma ’ plaċebo u kien simili għall- fergħa ta ’ referenza ta ’ lorazepam.
The observed mean improvement from baseline on the PANSS Excitement Component score at the primary 2-hour endpoint was 5.8 for placebo, 9.6 for lorazepam, and 8.7 for aripiprazole.
It- titjib medju osservat mil- linja bażi fuq l- iskor PANSS Excitement Component f’ punt ta ’ tmiem primarju ta ’ sagħtejn kien 5. 8 għal plaċebo, 9. 6 għal lorazepam, u 8. 7 għal aripiprazole.
In subpopulation analyses on patients with mixed episodes or on patients with severe agitation, a similar pattern of efficacy to the overall population was observed but statistical significance could not be established due to a reduced sample size.
F’ analiżi ta ’ subpopolazzjoni fuq pazjenti b’ episodji mħallta jew fuq pazjenti b’ aġitazzjoni severa, ġiet osservata tendenza simili ta ’ effikaċja għall- popolazzjoni ġenerali iżda s- sinifikat statistiku ma setax jiġi stabbilit minħabba daqs imnaqqas tal- kampjun.
Schizophrenia with oral aripiprazole:
Skizofrenja b' soluzzjoni aripiprazole orali:
In three short-term (4 to 6 weeks) placebo-controlled trials involving 1,228 schizophrenic patients, presenting with positive or negative symptoms, oral aripiprazole was associated with statistically significantly greater improvements in psychotic symptoms compared to placebo.
Fi tliet provi kliniċi fuq medda qasira (4 sa 6 ġimgħat) ikkontrollati minn plaċebo li fihom kienu involuti 1, 228 pazjent skiżofreniku li wrew sintomi pożittivi jew negattivi, l- aripiprazole orali kien assoċjat ma ’ titjib statistikament sinifikanti akbar fis- sintomi psikotiċi meta mqabbla mal- plaċebo.
In a haloperidol-controlled trial, the proportion of responder patients maintaining response to medicinal product at 52-weeks was similar in both groups (oral aripiprazole 77% and haloperidol 73%).
Waqt prova kkontrollata b’ haloperidol, il- proporzjon tal- pazjenti li irrispondew li żammew rispons għall- prodott mediċinali għall- 52 ġimgħa kien simili fiż- żewġ gruppi (aripiprazole 77% u haloperidol 73%).
The overall completion rate was significantly higher for patients on oral aripiprazole (43%) than for oral haloperidol (30%).
Ir- rata globali ta ’ dawk li spiċċaw il- kors kienet sinifikament ogħla għall- pazjenti fuq aripiprazole (43%) milli għall- haloperidol (30%).
In a 26-week, placebo-controlled trial in stabilised patients with chronic schizophrenia, oral aripiprazole had significantly greater reduction in relapse rate, 34% in oral aripiprazole group and 57% in placebo.
Fi provi ta ’ 26 ġimgħa kkontrollati bil- plaċebo f ’ pazjenti stabbilizzati, bi skizofrenja kronika, l - aripiprazole orali kellu tnaqqis sinifikament akbar fir- rata ta 'pazjenti li rkadew, 34% fil- grupp ta ’ aripiprazole orali u 57% fil- plaċebo.
Weight gain: in clinical trials oral 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 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 oral aripiprazole (N= 18, or 13% of evaluable patients), compared to oral olanzapine (N= 45, or 33% of evaluable patients).
106 inqas ta ’ 5. 6 kg għall- punt medjan tal- linja bażi tal- piż – 80. 5 kg) fuq aripiprazole (N= 18, jew 13% tal- pazjenti evalwabbli), mqabbla ma ’ olanzapine orali (N= 45, jew 33% tal- pazjenti evalwabbli).
Manic episodes in Bipolar I Disorder with oral aripiprazole:
Episodji manijaċi f’ Disturb Bipolari I b’ aripiprazole orali:
In two 3-week, flexible-dose, placebo-controlled monotherapy trials involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole demonstrated superior efficacy to placebo in reduction of manic symptoms over 3 weeks.
F’ żewġ provi ta ’ monoterapija kkontrollati bi plaċebo, b’ doża flessibbli ta ’ tliet ġimgħat li nvolvew pazjenti b’ episodju manijaku jew imħallat ta ’ Disturb Bipolari I, aripiprazole wera effikaċja superjuri għal plaċebo fit- tnaqqis ta ’ sintomi manijaċi fuq 3 ġimgħat.
These trials included patients with or without psychotic features and with or without a rapid-cycling course.
Dawn il- provi nkludew pazjenti bi jew mingħajr karatteristiċi psikotiċi u bi jew mingħajr kors ta ’ ċiklaġġ rapidu.
In one 3-week, fixed-dose, placebo-controlled monotherapy trial involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole failed to demonstrate superior efficacy to placebo.
Fi prova ta ’ monoterapija kkontrollata bi plaċebo b’ doża fissa ta ’ 3 ġimgħat li nvolviet pazjenti b’ episodju manijaku jew imħallat ta ’ Disturb Bipolari I, aripiprazole naqas milli juri effikaċja superjuri għal plaċebo.
In two 12-week, placebo- and active-controlled monotherapy trials in patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, aripiprazole demonstrated superior efficacy to placebo at week 3 and a maintenance of effect comparable to lithium or haloperidol at week 12.
Fi provi ta ’ monoterapija kkontrollati bi plaċebo u b’ mod attiv ta ’ 12- il ġimgħa li nvolvew pazjenti b’ episodju manijaku jew imħallat ta ’ Disturb Bipolari I, bi jew mingħajr karatteristiċi psikotiċi, aripiprazole wera effikaċja superjuri għal plaċebo f’ ġimgħa 3 u wera żamma ta ’ l- effett komparabbli għal- litju jew haloperidol f’ ġimgħa 12.
Aripiprazole also demonstrated a comparable proportion of patients in symptomatic remission from mania as lithium or haloperidol at week 12.
Aripiprazole wera wkoll proporzjon komparabbli ta ’ pazjenti f’ remissjoni simtomatika minn manija bħala litju jew haloperidol f’ ġimgħa 12.
In a 6-week, placebo-controlled trial involving patients with a manic or mixed episode of Bipolar I Disorder, with or without psychotic features, who were partially non-responsive to lithium or valproate monotherapy for 2 weeks at therapeutic serum levels, the addition of aripiprazole as adjunctive therapy resulted in superior efficacy in reduction of manic symptoms than lithium or valproate monotherapy.
Fi prova kkontrollata bi plaċebo ta ’ 6 ġimgħat li involviet pazjenti b’ episodju manijaku jew imħallat ta ’ Disturb Bipolari I, bi jew mingħajr karatteristiċi psikotiċi, li kienu parzjalment mhux risponsivi għal litju jew monoterapija ta ’ valproate għal ġimagħtejn f’ livelli ta ’ serum terapewtiċi, iż- żieda ta ’ aripiprazole bħala terapija aġġuntiva rriżultat f’ effikaċja superjuri fit- tnaqqis tas- sintomi manijaċi milli litju jew monoterapija ta ’ valproate.
102 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 kisbu remissjoni b’ aripiprazole matul fażi ta ’ stabbilizzazzjoni qabel randomizzazzjoni, aripiprazole wera superjorità fuq plaċebo fil- prevenzjoni ta ’ rikorrenza bipolari, primarjament fil- prevenzjoni ta ’ rikorrenza f’ manija iżda naqas li juri superjorità fuq plaċebo fil- prevenzjoni ta ’ rikorrenza f’ depressjoni.
Aripiprazole solution for injection administered intramuscularly as a single-dose to healthy subjects is well absorbed and has an absolute bioavailability of 100%.
Soluzzjoni aripipazole għall- injezzjoni mogħtija fil- muskolu bħala doża waħda lil nies b' saħħithom tkun assorbita sew u għandha biodisponibbilità assoluta ta '100%.
The aripiprazole AUC in the first 2 hours after an intramuscular injection was 90% greater than the AUC after the same dose as a tablet; systemic exposure was generally similar between the 2 formulations.
L- aripiprazole AUC fl- ewwel sagħtejn wara injezzjoni fil- muskolu kien 90% aktar minn l- AUC wara l- istess doża bħala pillola; l - espożizzjoni sistematika kienet ġeneralment l- istess bejn iż- żewġ formulazzjonijiet.
In 2 studies in healthy subjects the median times to the peak plasma concentrations were 1 and 3 hours after dosing.
F' żewġ studji f' nies b' saħħithom il- ħinijiet medjani sa l- ogħla konċentrazzjonijiet tal- plażma kienu siegħa u tliet sigħat wara d- doża.
The total body clearance of aripiprazole is 0.7 ml/ min/ kg, which is primarily hepatic.
107 Ir- rata ta ’ l- eliminazzjoni sħiħa mill- ġisem ta ’ aripiprazole hija ta ’ 0. 7 ml/ min/ kg, li sseħħ l- aktar fil - fwied.
Pharmacokinetics in special patient groups
Farmakokinetiċi fi gruppi ta 'pazjenti speċjali
103 Renal Disease:
Mard tal- kliewi:
Administration of aripiprazole solution for injection was well tolerated and produced no direct target organ toxicity in rats or monkeys after repeated dosing at systemic exposures (AUC) that were 15 and 5 times, respectively, human exposure at the maximum recommended human dose of 30 mg intramuscular.
L- għoti ta 'soluzzjoni aripiprazole għall- injezzjoni kienet tollerata tajjeb u ma pproduċiet l- ebda vvelenar dirett direttament lejn xi organu f' firien jew xadini wara li ngħataw dożi ripetuti b' espożizzjoni sistematika (AUC) li kienu 15 u 5 darbiet, rispettivament, l- espożizzjoni umana tad - doża umana massima rakkomaandata ta '30 mg fil- muskolu.
In intravenous reproductive toxicity studies, no new safety concerns were observed at maternal exposures up to 15 (rat) and 29 (rabbit) times human exposure at 30 mg.
Fi studji ta 'vvellenar reprodduttiv mill - vini, ma kien osservat l- ebda tħassib ġdid li jikkonċerna s- saħħa f' espożizzjonijiet materni sa 15 (far) u 29 (fenek) darba l- espożizzjoni umana ta' 30 mg.
Non-clinical safety data revealed no special hazard for humans based on conventional oral aripiprazole studies of safety pharmacology, repeat-dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta 'aripiprazole orali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin.
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).
L- ogħla
The highest nontumorigenic exposure in female rats was 7 times the human exposure at the recommended dose.
108 espożizzjoni li ma tirriżultax f' tumur f 'firien nisa kienet 7 darbiet l- espożizzjoni umana bid- doża rakkommondata.
An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of hydroxy metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 to 125 mg/ kg/ day (1 to 3 times the mean steady-state AUC at the maximum recommended clinical dose 2 or 16 to 81 times the maximum recommended human dose based on mg/ m).
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 - 2 bnedmin jew 16 sa 81 darba iktar mid- doża massima rakkomandata fil- bniedem imkejla bħala mg/ m).
Sulfobutylether β -cyclodextrin (SBECD) Tartaric acid Sodium hydroxide Water for injection
Sulfobutylether β- cyclodextrin (SBECD) Tartaric acid Sodium hydroxide Ilma għall- injezzjonijiet
18 months Use product immediately after opening and discard any unused amount.
18- il xahar Uża l- prodott immedjatament kif tiftħu u armi kwalunkwe parti li ma tużax.
Each carton contains one single-use type I glass vial with a rubber butyl stopper and a "flip-off" aluminium seal.
Kull kartuna fiha kunjett tal- ħġieġ tat- tip I li jintuża darba biss b' tapp tal- gomma sintetika u siġill ta 'l - aluminju li jitqaċċat.
Otsuka Pharmaceutical Europe Ltd.
109 Otsuka Pharmaceutical Europe Ltd.
105 ANNEX II
110 ANNESS II
A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A ID- DETENTUR TA 'L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL - LOTT
B CONDITIONS OF THE MARKETING AUTHORISATION
B KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
106 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
111 A ID- DETENTUR TA 'L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall- produzzjoni
Bristol-Myers Squibb Srl Contrada Fontana Del Ceraso I-03012 Anagni-Frosinone Italy
Bristol- Myers Squibb Srl Contrada Fontana Del Ceraso I- 03012 Anagni- Frosinone L- Italja
B CONDITIONS OF THE MARKETING AUTHORISATION
B KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA 'L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
Otsuka Pharmaceutical Europe Ltd commits to provide a PSUR at 6 monthly intervals unless otherwise decided by the CHMP.
Otsuka Pharmaceutical Europe Ltd timpennja ruħha li tipprovdi PSUR f' 6 intervalli ta 'xahar' il wieħed sakemm ma jkunx hemm deċiżjoni oħra mill- CHMP.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 1. 0 ippreżentata fil- Modulu 1. 8. 1. ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun qed taħdem tajjeb qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ Ġestjoni tar- Riskji Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq jimpenja ruħu li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil - verżjoni 3. 0 tal- Pjan ta ’ Ġestjoni tar- Riskji (RMP) ppreżentat fil- Modulu 1. 8. 2. ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornament sussegwenti ieħor tal- RMP miftiehem mill- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tal- CHMP dwar is- Sistemi ta ’ Ġestjoni tar- Riskji għal prodotti mediċinali għal użu mill- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess żmien tar- Rapport ta ’ Aġġornament Perjodiku dwar is- Sigurtà (PSUR).
In addition, an updated RMP should be submitted When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat Meta tiġi rċevuta informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà, il - Pjan ta ’ Farmakoviġilanza jew l- attivitajiet ta ’ minimizzazzjoni tar- riskji Fi żmien 60 jum minn meta tkun intlaħqet mira importanti (farmakoviġilanza jew minimizzazzjoni tar- riskji) Fuq talba ta ’ l- EMEA
107 ANNEX III
112 ANNESS III
109 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
114 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ABILIFY 5 mg tablets aripiprazole
ABILIFY 5 mg pilloli aripiprazole
Each tablet contains 5 mg of aripiprazole.
Kull pillola għandha 5 mg ta 'aripiprazole.
Also contains: lactose monohydrate.
Fih ukoll: lactose monohydrate.
14 x 1 tablets 28 x 1 tablets 49 x 1 tablets 56 x 1 tablets 98 x 1 tablets
14 x 1 pilloli 28 x 1 pilloli 49 x 1 pilloli 56 x 1 pilloli 98 x 1 pilloli
EU/ 1/ 04/ 276/ 001 14 x 1 tablets EU/ 1/ 04/ 276/ 002 28 x 1 tablets EU/ 1/ 04/ 276/ 003 49 x 1 tablets EU/ 1/ 04/ 276/ 004 56 x 1 tablets EU/ 1/ 04/ 276/ 005 98 x 1 tablets
EU/ 1/ 04/ 276/ 001 14 x 1 pilloli EU/ 1/ 04/ 276/ 002 28 x 1 pilloli EU/ 1/ 04/ 276/ 003 49 x 1 pilloli EU/ 1/ 04/ 276/ 004 56 x 1 pilloli EU/ 1/ 04/ 276/ 005 98 x 1 pilloli
ABILIFY 5 mg
ABILIFY5 mg
111 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
116 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI U FUQ L- ISTRIXXI
BLISTERS
STRIXXI
112 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
117 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ABILIFY 10 mg tablets aripiprazole
ABILIFY 10 mg pilloli aripiprazole
Each tablet contains 10 mg of aripiprazole.
Kull pillola għandha 10 mg ta 'aripiprazole.
EU/ 1/ 04/ 276/ 006 14 x 1 tablets EU/ 1/ 04/ 276/ 007 28 x 1 tablets EU/ 1/ 04/ 276/ 008 49 x 1 tablets EU/ 1/ 04/ 276/ 009 56 x 1 tablets EU/ 1/ 04/ 276/ 010 98 x 1 tablets
EU/ 1/ 04/ 276/ 006 14 x 1 pilloli EU/ 1/ 04/ 276/ 007 28 x 1 pilloli EU/ 1/ 04/ 276/ 008 49 x 1 pilloli EU/ 1/ 04/ 276/ 009 56 x 1 pilloli EU/ 1/ 04/ 276/ 010 98 x 1 pilloli
ABILIFY 10 mg
ABILIFY10 mg
114 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
119 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI U FUQ L- ISTRIXXI
115 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
120 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ABILIFY 15 mg tablets aripiprazole
ABILIFY 15 mg pilloli aripiprazole
Each tablet contains 15 mg of aripiprazole.
Kull pillola għandha 15 mg ta 'aripiprazole.
EU/ 1/ 04/ 276/ 011 14 x 1 tablets EU/ 1/ 04/ 276/ 012 28 x 1 tablets EU/ 1/ 04/ 276/ 013 49 x 1 tablets EU/ 1/ 04/ 276/ 014 56 x 1 tablets EU/ 1/ 04/ 276/ 015 98 x 1 tablets
EU/ 1/ 04/ 276/ 011 14 x 1 pilloli EU/ 1/ 04/ 276/ 012 28 x 1 pilloli EU/ 1/ 04/ 276/ 013 49 x 1 pilloli EU/ 1/ 04/ 276/ 014 56 x 1 pilloli EU/ 1/ 04/ 276/ 015 98 x 1 pilloli
ABILIFY 15 mg
ABILIFY15 mg
117 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
122 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI U FUQ L- ISTRIXXI
ABILIFY 30 mg tablets aripiprazole
ABILIFY 30 mg pilloli aripiprazole
EU/ 1/ 04/ 276/ 016 14 x 1 tablets EU/ 1/ 04/ 276/ 017 28 x 1 tablets EU/ 1/ 04/ 276/ 018 49 x 1 tablets EU/ 1/ 04/ 276/ 019 56 x 1 tablets EU/ 1/ 04/ 276/ 020 98 x 1 tablets
EU/ 1/ 04/ 276/ 016 14 x 1 pilloli EU/ 1/ 04/ 276/ 017 28 x 1 pilloli EU/ 1/ 04/ 276/ 018 49 x 1 pilloli EU/ 1/ 04/ 276/ 019 56 x 1 pilloli EU/ 1/ 04/ 276/ 020 98 x 1 pilloli
ABILIFY 30 mg
ABILIFY30 mg
120 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
125 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI U FUQ L- ISTRIXXI
121 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
126 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON
PAKKETT TA ’ BARRA
ABILIFY 10 mg orodispersible tablets aripiprazole
ABILIFY 10 mg pilloli li jinħallu fil- ħalq aripiprazole
Each tablet contains 10 mg of aripiprazole.
Kull pillola fiha 10 mg aripiprazole.
14 x 1 orodispersible tablets 28 x 1 orodispersible tablets 49 x 1 orodispersible tablets
14 x 1 pilloli li jinħallu fil- ħalq 28 x 1 pilloli li jinħallu fil- ħalq 49 x 1 pilloli li jinħallu fil- ħalq
Contains aspartame.
Għandu l- aspartame.
EU/ 1/ 04/ 276/ 024 14 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 025 28 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 026 49 x 1 orodispersible tablets
EU/ 1/ 04/ 276/ 024 14 x 1 pilloli li jinħallu fil- ħalq EU/ 1/ 04/ 276/ 025 28 x 1 pilloli li jinħallu fil- ħalq EU/ 1/ 04/ 276/ 026 49 x 1 pilloli li jinħallu fil- ħalq
123 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
128 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TA 'L- AWTORIZZAZZJONI TAL- KUMMERĊ
ABILIFY 15 mg orodispersible tablets aripiprazole
ABILIFY 15 mg pilloli li jinħallu fil- ħalq aripiprazole
Each tablet contains 15 mg of aripiprazole.
Kull pillola fiha 15 mg aripiprazole.
EU/ 1/ 04/ 276/ 027 14 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 028 28 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 029 49 x 1 orodispersible tablets
EU/ 1/ 04/ 276/ 027 14 x 1 pilloli li jinħallu fil- ħalq EU/ 1/ 04/ 276/ 028 28 x 1 pilloli li jinħallu fil- ħalq EU/ 1/ 04/ 276/ 029 49 x 1 pilloli li jinħallu fil- ħalq
127 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
132 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
ABILIFY 30 mg orodispersible tablets aripiprazole
ABILIFY 30 mg pilloli li jinħallu fil- ħalq aripiprazole
Each tablet contains 30 mg of aripiprazole.
Kull pillola fiha 30 mg aripiprazole.
EU/ 1/ 04/ 276/ 030 14 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 031 28 x 1 orodispersible tablets EU/ 1/ 04/ 276/ 032 49 x 1 orodispersible tablets
EU/ 1/ 04/ 276/ 030 14 x 1 pilloli li jinħallu fil- ħalq EU/ 1/ 04/ 276/ 031 28 x 1 pilloli li jinħallu fil- ħalq EU/ 1/ 04/ 276/ 032 49 x 1 pilloli li jinħallu fil- ħalq
129 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
134 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
130 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
135 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON AND BOTTLE LABEL
KARTUNA TA 'BARRA U TIKKETTA TAL- FLIXKUN
ABILIFY 1 mg/ ml oral solution aripiprazole
ABILIFY 1 mg/ ml soluzzjoni orali aripiprazole
Contains fructose, sucrose, E218, and E216.
Għandu fructose, sucrose, E218, u E216.
50 ml oral solution 150 ml oral solution 480 ml oral solution
50 ml soluzzjoni orali 150 ml soluzzjoni orali 480 ml soluzzjoni orali
EXP Use within 6 months after first opening.
JIS Uża fi żmien 6 xhur minn meta jinfetaħ għall- ewwel darba.
Otsuka Pharmaceutical Europe Ltd.
Kartuna ta 'barra Otsuka Pharmaceutical Europe Ltd.
EU/ 1/ 04/ 276/ 033 - 50 ml bottle EU/ 1/ 04/ 276/ 034 - 150 ml bottle EU/ 1/ 04/ 276/ 035 - 480 ml bottle
EU/ 1/ 04/ 276/ 033 - flixkun ta '50 ml EU/ 1/ 04/ 276/ 034 - flixkun ta' 150 ml EU/ 1/ 04/ 276/ 035 - flixkun ta '480 ml
Outer carton:
Kartuna ta 'barra:
ABILIFY 7.5 mg/ ml solution for injection aripiprazole
ABILIFY 7. 5 mg/ ml soluzzjoni għall- injezzjoni aripiprazole
A vial provides 9.75 mg in 1.3 ml
Kunjett jagħti 9. 75 mg f '1. 3ml.
Also contains sulfobutylether b-cyclodextrin, tartaric acid, sodium hydroxide, and water for injection.
Għandu wkoll sulfobutylether b- cyclodextrin, tartaric acid, sodium hydroxide, u ilma għall- injezzjoni.
Solution for injection 1 vial
Soluzzjoni għall- injezzjoni 1 kunjett
Intramuscular use Read the package leaflet before use.
Għal użu għal ġol- muskoli Aqra l- fuljett ta 'tagħrif qabel l- użu.
As ABILIFY 7.5 mg/ ml solution for injection is only intended for administration by health care professionals, no information will be included in Braille.
Minħabba li s- soluzzjoni għall- injezzjoni ABILIFY 7. 5 mg/ ml hija maħsuba għall- għoti minn professjonisti għall- kura tas- saħħa, ebda informazzjoni bil- Braille mhu se tkun inkluża.
134 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
139 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
ABILIFY 7.5 mg/ ml solution for injection aripiprazole Intramuscular use
ABILIFY 7. 5 mg/ ml soluzzjoni għall- injezzjoni aripiprazole Għal użu għal ġol- muskoli
9.75 mg (1.3ml)
9. 75 mg (1. 3 ml)
136 PACKAGE LEAFLET:
141 FULJETT TA 'TAGĦRIF:
Read all of this leaflet carefully before you start taking this medicine.
Aqra dan il- fuljett kollu qabel tibda tuża din il- mediċina.
It may harm them, even if their symptoms are the same as yours.
Tista 'tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.