natgillin/translations-raw huggingface dataset:
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
62, 18 mg lactose per tablet.
62.18 mg lactose per tablet
Tablet Rektangulær og lyserød, graveret med ” A- 008” og ” 10 ” på den ene side.
Tablet Rectangular and pink, engraved with "A-008" and "10" on one side.
5. 2).
13 maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
14 behandling med aripiprazol.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered
Kliniske manifestationer af NMS er hyperpyreksi, muskelstivhed, ændret mental tilstand og tegn på autonom ustabilitet (uregelmæssig puls eller blodtryk, takykardi, diaforese og hjertearytmi).
14 mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
15 4. 5 Interaktion med andre lægemidler og andre former for interaktion
15 4.5 Interaction with other medicinal products and other forms of interaction
Ved samtidig administration af valproat eller lithium og aripiprazol sås ingen klinisk signifikant ændring i koncentrationerne af aripiprazol.
16 When either valproate or lithium were administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations.
16 Andre lægemidler, der kan påvirkes af ABILIFY:
Potential for ABILIFY to affect other medicinal products:
Ekstrapyramidale symptomer (EPS):
17 Extrapyramidal symptoms (EPS):
Skizofreni - I et længerevarende, 52- ugers kontrolleret forsøg havde aripiprazol- behandlede patienter totalt set en lavere forekomst (25, 8%) af EPS, inklusive parkinsonisme, akatisi, dystoni og dyskinesi sammenlignet med patienter behandlet med haloperidol 17 (57, 3%).
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%).
Knogler, led, muskler og bindevæv:
Skin and subcutaneous tissue disorders:
hyperglykæmi, diabetes mellitus, diabetisk ketoacidose, diabetisk hyperosmolært koma
rash, photosensitivity reaction, alopecia, hyperhidrosis
Metabolisme og ernæring:
Musculoskeletal and connective tissue disorders:
vægtøgning, vægttab, anoreksi, hyponatræmi
rhabdomyolysis, myalgia, stiffness
Vaskulære sygdomme:
Endocrine disorders:
Det er foreslået, at aripiprazols virkning på skizofreni og bipolar lidelse type 1 medieres gennem en kombination af partiel agonisme på dopamin D2 - og serotonin 5- HT1a- receptorer samt antagonisme på serotonin 5- HT2a- receptorer.
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.
I et 26- ugers, placebokontrolleret forsøg, efterfulgt af en 74- ugers forlængelse, med maniske patienter, som oplevede remission med aripiprazol under en stabiliseringsfase inden randomisering, havde aripiprazol bedre effekt end placebo ved forebyggelse af bipolært recidiv, primært ved at forebygge recidiv af mani, men havde ikke bedre effekt end placebo ved forebyggelse af recidiv af depression.
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.
20 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
Leverlidelse:
21 Hepatic Disease:
21 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
6. 4 Særlige opbevaringsforhold
22 6.4 Special precautions for storage
22 6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container
57 mg lactose per tablet.
57 mg lactose per tablet
Tablet Rund og gul, graveret med ” A- 009” og ” 15 ” på den ene side.
Tablet Round and yellow, engraved with "A-009" and "15" on one side.
5. 2).
24 maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
Kliniske manifestationer af NMS er hyperpyreksi, muskelstivhed, ændret mental tilstand og tegn på autonom ustabilitet (uregelmæssig puls eller blodtryk, takykardi, diaforese og hjertearytmi).
25 mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
26 4. 5 Interaktion med andre lægemidler og andre former for interaktion
26 4.5 Interaction with other medicinal products and other forms of interaction
Andre potente CYP3A4- induktorer (fx rifampicin, rifabutin, fenytoin, fenobarbital, primidon, efavirenz, nevarapin og perikum) kan forventes at have lignende virkninger, og lignende dosisøgninger bør derfor anvendes.
Other potent inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St.
Ved seponering af potente CYP3A4- induktorer bør dosis af ABILIFY nedsættes til den anbefalede dosis.
John's Wort) may be expected to have similar effects and similar dose increases should therefore be applied.
Ved samtidig administration af valproat eller lithium og aripiprazol sås ingen klinisk signifikant ændring i koncentrationerne af aripiprazol.
Upon discontinuation of potent CYP3A4 inducers, the dosage of ABILIFY should be reduced to the recommended dose.
27 Andre lægemidler, der kan påvirkes af ABILIFY:
27 When either valproate or lithium were administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations.
Ekstrapyramidale symptomer (EPS):
28 Extrapyramidal symptoms (EPS):
Skizofreni - I et længerevarende, 52- ugers kontrolleret forsøg havde aripiprazol- behandlede patienter totalt set en lavere forekomst (25, 8%) af EPS, inklusive parkinsonisme, akatisi, dystoni og dyskinesi sammenlignet med patienter behandlet med haloperidol 28 (57, 3%).
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%).
Det er foreslået, at aripiprazols virkning på skizofreni og bipolar lidelse type 1 medieres gennem en kombination af partiel agonisme på dopamin D2 - og serotonin 5- HT1a- receptorer samt antagonisme på serotonin 5- HT2a- receptorer.
30 It has been proposed that aripiprazole’ s efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
I et 26- ugers, placebokontrolleret forsøg, efterfulgt af en 74- ugers forlængelse, med maniske patienter, som oplevede remission med aripiprazol under en stabiliseringsfase inden randomisering, havde aripiprazol bedre effekt end placebo ved forebyggelse af bipolært recidiv, primært ved at forebygge recidiv af mani, men havde ikke bedre effekt end placebo ved forebyggelse af recidiv af depression.
31 In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who achieved remission on aripiprazole during a stabilization phase prior to randomization, aripiprazole demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into depression.
31 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
32 5. 3 Prækliniske sikkerhedsdata
32 Hepatic Disease:
6. 4 Særlige opbevaringsforhold
33 6.4 Special precautions for storage
33 6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container
186, 54 mg lactose per tablet.
186.54 mg lactose per tablet
Tablet Rund og lyserød, graveret med ” A- 011” og ” 30 ” på den ene side.
Tablet Round and pink, engraved with "A-011" and "30" on one side.
5. 2).
35 maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
Kliniske manifestationer af NMS er hyperpyreksi, muskelstivhed, ændret mental tilstand og tegn på autonom ustabilitet (uregelmæssig puls eller blodtryk, takykardi, diaforese og hjertearytmi).
36 mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
37 4. 5 Interaktion med andre lægemidler og andre former for interaktion
37 4.5 Interaction with other medicinal products and other forms of interaction
38 Andre lægemidler, der kan påvirkes af ABILIFY:
38 When either valproate or lithium were administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations.
Ekstrapyramidale symptomer (EPS):
39 Extrapyramidal symptoms (EPS):
Skizofreni - I et længerevarende, 52- ugers kontrolleret forsøg havde aripiprazol- behandlede patienter totalt set en lavere forekomst (25, 8%) af EPS, inklusive parkinsonisme, akatisi, dystoni og dyskinesi sammenlignet med patienter behandlet med haloperidol 39 (57, 3%).
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%).
Det er foreslået, at aripiprazols virkning på skizofreni og bipolar lidelse type 1 medieres gennem en kombination af partiel agonisme på dopamin D2 - og serotonin 5- HT1a- receptorer samt antagonisme på serotonin 5- HT2a- receptorer.
41 It has been proposed that aripiprazole’ s efficacy in schizophrenia and Bipolar I Disorder is mediated through a combination of partial agonism at dopamine D2 and serotonin 5HT1a receptors and antagonism of serotonin 5HT2a receptors.
I et 26- ugers, placebokontrolleret forsøg, efterfulgt af en 74- ugers forlængelse, med maniske patienter, som oplevede remission med aripiprazol under en stabiliseringsfase inden randomisering, havde aripiprazol bedre effekt end placebo ved forebyggelse af bipolært recidiv, primært ved at forebygge recidiv af mani, men havde ikke bedre effekt end placebo ved forebyggelse af recidiv af depression.
42 In a 26-week, placebo-controlled trial, followed by a 74-week extension, in manic patients who achieved remission on aripiprazole during a stabilization phase prior to randomization, aripiprazole demonstrated superiority over placebo in preventing bipolar recurrence, primarily in preventing recurrence into mania but failed to demonstrate superiority over placebo in preventing recurrence into depression.
42 5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
43 5. 3 Prækliniske sikkerhedsdata
43 Hepatic Disease:
6. 4 Særlige opbevaringsforhold
44 6.4 Special precautions for storage
44 6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container
2 mg aspartam (E951) per smeltetablet.
2 mg aspartame (E951) per orodispersible tablet
Smeltetablet Rund og lyserød, mærket med "A" over "640" på den ene side og ” 10 ” på den anden side.
Orodispersible tablet Round and pink, marked with "A" over "640" on one side and "10" on the other.
Den anbefalede startdosis for ABILIFY er 10 eller 15 mg/ dag med en vedligeholdelsesdosis på 15 mg/ dag, administreret som en enkelt daglig dosis uden hensyntagen til måltider.
The recommended starting dose for ABILIFY is 10 or 15 mg/ day with a maintenance dose of 15 mg/ day administered on a once-a-day schedule without regard to meals.
ABILIFY er effektiv i dosisområdet 10- 30 mg/ dag (dvs.
ABILIFY is effective in a dose range of 10 to 30 mg/ day.
Smeltetabletten skal lægges på tungen, hvor den opløses hurtigt i mundvandet.
The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disperse in saliva.
Det er svært at fjerne en intakt smeltetablet fra munden.
Removal of the intact orodispersible tablet from the mouth is difficult.
5. 2).
46 The orodispersible tablets may be used as an alternative to ABILIFY tablets for patients who have difficulty to swallow ABILIFY tablets (see also section 5.2).
5. 2).
However, the maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
4. 5).
Smoking status: according to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers (see section 4.5).
Høj- risikopatienter bør overvåges tæt under antipsykotisk behandling.
Close supervision of high-risk patients should accompany antipsychotic therapy.
I kliniske forsøg, af en varighed på et år eller kortere, er der kun sjældent indberettet behandlingsbetingede dyskinesier under behandling med aripiprazol.
47 Tardive Dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
Vægtstigning: vægtstigning er almindeligt forekommende hos patienter med skizofreni og bipolar sygdom pga. samtidige sygdomme, anvendelse af antipsykotika der vides at forårsage vægtstigning og dårlig livsstil og kan medføre alvorlige komplikationer.
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.
48 Dysfagi: øsofagusdysmotilitet og aspiration er forbundet med anvendelse af antipsykotika inklusive ABILIFY.
48 Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
Phenylketonuri:
Phenylketonurics:
4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction
Ligeledes var de geometriske middelværdier for dehydro- aripiprazol for Cmax og AUC efter samtidig brug af carbamazepin henholdsvis 69% og 71% lavere end ved behandling med aripiprazol alene.
49 of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
49 Dosis af ABILIFY bør fordobles ved samtidig administration af ABILIFY og carbamazepin.
ABILIFY dose should be doubled when concomitant administration of ABILIFY occurs with carbamazepine.
Andre lægemidler, der kan påvirkes af ABILIFY:
Potential for ABILIFY to affect other medicinal products:
Der sås ingen kliniske signifikante ændringer i valproat - eller lithiumkoncentrationer ved samtidig administration af aripiprazol og valproat eller lithium
When aripiprazole was administered concomitantly with either valproate or lithium, there was no clinically important change in valproate or lithium concentrations.
50 Hjerte Ikke almindelige: takykardi * Nervesystemet Almindelige: ekstrapyramidale forstyrrelser, akathisia, tremor, svimmelhed, søvnighed, sedering, hovedpine Øjne Almindelige: sløret syn Mave- tarmkanalen Almindelige: dyspepsi, opkastning, kvalme, opstipation, hypersekretion af spyt Vaskulære sygdomme Ikke almindelige: ortostatisk hypotension * Almene symptomer og reaktioner på administrationsstedet Almindelige: træthed Psykiske forstyrrelser Almindelige: rastløshed, søvnløshed, ængstelse Ualmindelige: depression *
50 Cardiac disorders Uncommon: tachycardia* Nervous System disorders Common: extrapyramidal disorder, akathisia, tremor, dizziness, somnolence, sedation, headache Eye disorders Common: blurred vision Gastrointestinal disorders Common: dyspepsia, vomiting, nausea, constipation, salivary hypersecretion Vascular disorders Uncommon: orthostatic hypotension* General disorders and administration site conditions Common: fatigue Psychiatric disorders Common: restlessness, insomnia, anxiety Uncommon: depression*
Ekstrapyramidale symptomer (EPS):
Extrapyramidal symptoms (EPS):
Skizofreni - I et længerevarende, 52- ugers kontrolleret forsøg havde aripiprazol- behandlede patienter totalt set en lavere forekomst (25, 8%) af EPS, inklusive parkinsonisme, akatisi, dystoni og dyskinesi sammenlignet med patienter behandlet med haloperidol (57, 3%).
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%).
I et andet 12- ugers forsøg var forekomsten af EPS 26, 6% for aripiprazol- behandlende patienter og 17, 6% for patienter lithium - behandlede patienter.
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.
leukopeni, neutropeni, thrombocytopeni 51
51 Nervous system disorders:
52 Medicinsk kul (50 g) administreret en time efter aripiprazol nedsatte aripiprazol Cmax med omkring 41% og AUC med omkring 51%; dette viser, at kul kan være effektivt i behandlingen af overdosering.
52 Activated charcoal (50 g), administered one hour after aripiprazole, decreased aripiprazole Cmax by about 41% and AUC by about 51%, suggesting that charcoal may be effective in the treatment of overdose.
Det er foreslået, at aripiprazols virkning på skizofreni og bipolar lidelse type 1 medieres gennem en kombination af partiel agonisme på dopamin D2 - og serotonin 5- HT1a- receptorer samt antagonisme på serotonin 5- HT2a- receptorer.
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.
Aripiprazol har høj bindingsaffinitet in vitro for dopamin D2 - og D3 -, serotonin 5- HT1a - og 5- HT2a - receptorer og moderat affinitet for dopamin D4 -, serotonin 5- HT2c - og 5- HT7 -, alfa 1- adrenerge og histamin H1 - receptorer.
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.
I to, 3- ugers placebokontrollerede enkeltstof- forsøg med fleksible doser til patienter med manisk eller blandet episode af bipolar lidelse type 1, viste aripiprazol bedre effekt end placebo til reduktion af de
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
53 maniske symptomer over 3 uger.
53 reduction of manic symptoms over 3 weeks.
I et 3- ugers, placebokontrolleret enkeltstof- forsøg med fast dosis til patienter med manisk eller blandet episode med bipolar lidelse type 1, havde aripiprazol ikke bedre effekt end placebo.
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.
I to, 12- ugers, placebo - og aktivt kontrollerede enkeltstof- forsøg med patienter med en manisk eller blandet episode af bipolar lidelse type 1, med eller uden psykotiske træk, havde aripiprazol bedre effekt end placebo ved uge 3 og en vedligeholdelse af effekt sammenlignelig med lithium eller haloperidol ved uge 12.
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.
I et 26- ugers, placebokontrolleret forsøg, efterfulgt af en 74- ugers forlængelse, med maniske patienter, som oplevede remission med aripiprazol under en stabiliseringsfase inden randomisering, havde aripiprazol bedre effekt end placebo ved forebyggelse af bipolært recidiv, primært ved at forebygge recidiv af mani, men havde ikke bedre effekt end placebo ved forebyggelse af recidiv af depression.
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.
5. 2 Farmakokinetiske egenskaber
5.2 Pharmacokinetic properties
Aripiprazol smeltetablet og apripiprazol tablet er bioækvivalente, med lignende absorptionshastighed og absorptionsgrad.
Aripiprazole orodispersible tablet is bioequivalent to aripiprazole tablets, with a similar rate and extent of absorption.
Aripiprazol smeltetabletter kan anvendes som alternativ til aripiprazol tabletter.
Aripiprazole orodispersible tablets may be used as an alternative to aripiprazole tablets.
54 Farmakokinetik i særlige patientgrupper
54 Pharmacokinetics in special patient groups
Leverlidelse:
Hepatic Disease:
5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Koncentrationerne af sulfatkonjugat af hydroxyaripiprazol i den humane galdeblære ved den højeste foreslåede dosis (30 mg/ dag) var dog ikke mere end 6% af de galdekoncentrationer, der sås hos aber i 39- ugers forsøget og lå godt under (6%) grænserne for in vitro opløselighed.
However, the concentrations of the sulphate conjugates of hydroxy aripiprazole in human bile at the highest dose proposed, 30 mg per day, were no more than 6% of the bile concentrations found in the monkeys in the 39-week study and are well below (6%) their limits of in vitro solubility.
Der er hos rotter observeret udviklingsmæssig toksicitet, inklusive dosisafhængig, forsinket føtal ossifikation og mulig teratogen effekt ved doser som resulterede i sub- terapeutisk optagelse (baseret på AUC), og i kaniner ved doser, der resulterede i optagelser henholdsvis 3 og 11 gange middel- steady- state AUC ved maksimal, anbefalet klinisk dosis.
Developmental toxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were observed in rats at doses resulting in subtherapeutic exposures (based on AUC) and in rabbits at doses resulting in exposures 3 and 11 times the mean steady-state AUC at the maximum recommended clinical dose.
Calciumsilicat Croscarmellosenatrium Crospovidon Silicondioxid Xylitol Mikrokrystallinsk cellulose Aspartam (E951) Acesulfamkalium Vanillesmagsstof (indeholdende vanillin og ethylvanillin) Vinsyre Magnesiumstearat
Calcium silicate Croscarmellose sodium Crospovidone Silicon dioxide Xylitol Microcrystalline cellulose Aspartame (E951) Acesulfame potassium Vanilla flavour (including vanillin and ethyl vanillin) Tartaric acid Magnesium stearate
6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
6. 5 Emballagetype og pakningsstørrelser
6.5 Nature and contents of container
Æsker indeholdende 14 x 1 tabletter i hård perforeret aluminium- enkeltdosisblister.
Carton of 14 x 1 tablets in cold-formed aluminium perforated unit dose blisters.
Æsker indeholdende 28 x 1 tabletter i hård perforeret aluminium- enkeltdosisblister.
Carton of 28 x 1 tablets in cold-formed aluminium perforated unit dose blisters.
Æsker indeholdende 49 x 1 tabletter i hård perforeret aluminium- enkeltdosisblister.
Carton of 49 x 1 tablets in cold-formed aluminium perforated unit dose blisters.
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
56 Date of first authorisation:
3 mg aspartam (E951) per smeltetablet.
3 mg aspartame (E951) per orodispersible tablet
Smeltetablet Rund og gul, mærket med "A" over "641" på den ene side og ” 15 ” på den anden side.
Orodispersible tablet Round and yellow, marked with "A" over "641" on one side and "15" on the other.
5. 2).
58 The orodispersible tablets may be used as an alternative to ABILIFY tablets for patients who have difficulty to swallow ABILIFY tablets (see also section 5.2).