natgillin/translations-raw huggingface dataset:
Hvis du ønsker yderligere oplysninger om baggrunden for CHMP' s anbefalinger, kan du læse de faglige drøftelser (også en del af denne EPAR).
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Abilify er et lægemiddel, der indeholder det aktive stof aripiprazol.
Abilify is a medicine containing the active substance aripiprazole.
Det fås som 5 mg, 10 mg, 15 mg og 30 mg tabletter eller som 10 mg, 15 mg og 30 mg smeltetabletter (tabletter, der opløses i munden), som oral opløsning (1 mg/ ml) og som injektionsvæske, opløsning (7, 5 mg/ ml).
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).
Abilify anvendes til behandling af voksne med følgende psykiske sygdomme: • skizofreni, en sindssygdom med en række symptomer, der blandt andet består i desorganiseret tankegang og tale, hallucinationer (opfattelsen af at høre eller se ting, som ikke er der), mistænksomhed og vrangforestillinger (forestillinger, der er ude af trit med virkeligheden). • bipolar lidelse type 1, en psykisk sygdom, hvor patienterne svinger mellem maniske episoder (perioder med unormalt højt humør) og perioder med normalt humør.
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.
De kan også have perioder med depression.
They may also have episodes of depression.
Abilify anvendes til at behandle moderate til svære maniske episoder og til at forebygge maniske episoder hos patienter, som tidligere har responderet på lægemidlet.
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.
Injektionsvæsken anvendes til hurtig kontrol af stærk uro eller forstyrret adfærd, når det ikke er hensigtsmæssigt at indtage medicinen gennem munden.
The solution for injection is used for the rapid control of agitation or disturbed behaviour when taking the medicine by mouth is not appropriate.
Ved skizofreni er den anbefalede startdosis 10 eller 15 mg dagligt, som indtages gennem munden.
For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day.
Vedligeholdelsesdosis er 15 mg én gang dagligt, men for nogle patienter kan højere dosis være gavnlig.
The maintenance dose is 15 mg once a day, but higher doses may benefit some patients.
Ved bipolar sygdom er den anbefalede startdosis 15 mg dagligt, som indtages gennem munden, en gang dagligt alene eller i kombination med andre lægemidler.
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.
For visse patienter kan en højere dosis være gavnlig.
Some patients may benefit from a higher dose.
For at forbygge mod maniske episoder bør den samme dosis fastholdes.
To prevent manic episodes, the same dose should be continued.
Ved begge sygdomme kan den orale opløsning eller smeltetabletterne anvendes til patienter, der har vanskeligt ved at synke tabletter.
For both illnesses, the oral solution or orodispersible tablets can be used in patients who have difficulty swallowing tablets.
Smeltetabletterne tages ved, at de lægges på tungen, hvor de hurtigt opløses af spyttet, eller ved at man opløser dem i vand, før de tages.
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.
Injektionsvæsken er kun til kort tids brug og bør snarest muligt afløses af tabletter, smeltetabletter eller oral opløsning: den sædvanlige dosis er 9, 75 mg, der gives som en enkelt injektion i overarmen eller ballemusklen, men doser mellem 5, 25 og 15 mg kan være effektive.
The solution for injection is only for short-term use and should be replaced by tablets, orodispersible tablets or oral solution as soon as possible: the usual dose is 9.75 mg as a single injection into the upper arm or buttock muscle, but effective doses range between 5.25 and 15 mg.
Om nødvendigt kan der 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. gives endnu en injektion mindst 2 timer efter den første.
Reproduction is authorised provided the source is acknowledged.
Abilify kan tages i forbindelse med et måltid eller mellem måltiderne.
Abilify can be taken with or without food.
Den daglige dosis Abilify bør ikke overstige 30 mg.
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.
Dosen af Abilify bør tilpasses hos patienter, der tager anden medicin, som nedbrydes på samme måde som Abilify.
The dose of Abilify should be adjusted in patients who are taking other medicines that are broken down in the same way as Abilify.
Abilify er ikke blevet undersøgt hos børn under 18 år og voksne over 65 år.
Abilify has not been studied in children aged below 18 years or adults aged over 65 years.
Dets nøjagtige virkningsmekanisme kendes ikke, men det bindes til flere forskellige receptorer på overfladen af nervecellerne i hjernen.
Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain.
Derved afbrydes de signaler, som hjernecellerne sender til hinanden ved hjælp af "neurotransmittere", dvs. kemiske stoffer, som af nerveceller anvendes til at kommunikere indbyrdes.
This disrupts signals transmitted between brain cells by ‘ neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
Aripiprazol menes hovedsageligt at virke som en ” partiel agonist ” for receptorerne for neurotransmitterne dopamin og 5- hydroxytryptamin (også kaldet serotonin).
Aripiprazole is thought to act mainly by being a ‘ partial agonist ’ for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Dette betyder, at aripiprazol virker som 5- hydroxytryptamin og dopamin for at aktivere receptorerne, men i mindre omfang end neurotransmitterne.
This means that aripiprazole acts like 5-hydroxytryptamine and dopamine to activate the receptors, but to a lesser extent than the neurotransmitters.
Da dopamin og 5- hydroxytryptamin er inddraget ved skizofreni og bipolar sygdom, medvirker aripiprazol til at normalisere hjerneaktiviteten, så de psykotiske og maniske symptomer mindskes og ikke kommer igen.
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.
Undersøgelserne varede 4 til 6 uger og omfattede 1 203 patienter og sammenlignede Abilify med placebo (en virkningsløs behandling).
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).
I to af disse undersøgelser blev haloperidol (et andet antipsykotisk middel) anvendt som sammenligningsstof.
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.
Virkningen af injektionsvæsken blev sammenlignet med placebo inden for to timer i to undersøgelser af 805 patienter med skizofreni eller beslægtede sygdomme, som alle havde urosymptomer.
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.
I alle undersøgelserne måltes ændringen i patienternes symptomer efter en standardskala for skizofreni.
All of the studies measured the change in the patient’ s symptoms using a standard scale for schizophrenia.
Med hensyn til behandlingen af bipolar sygdom blev der foretaget otte undersøgelser af Abilify indtaget gennem munden.
For the treatment of bipolar disorder, there were eight main studies looking at Abilify taken by mouth.
Der var fem undersøgelser af kort tids varighed, som sammenlignede virkningen af Abilify og placebo i løbet af tre uger hos i alt 1 900 patienter.
There were five short-term studies that compared the effectiveness of Abilify and placebo over three weeks in a total of 1,900 patients.
To af disse undersøgelser anvendte haloperidol og lithium (et andet antipsykotisk middel) som sammenligningsstoffer og fortsatte i yderligere ni uger for at se på lægemidlernes vedvarende virkning.
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.
En anden undersøgelse sammenlignede Abilify med haloperidol i løbet af 12 uger hos 347 patienter, og en yderligere undersøgelse sammenlignede virkningen af Abilify og placebo til at forebygge tilbagefald hos 160 patienter, hos hvem de maniske symptomer allerede havde stabiliseret sig med Abilify.
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.
De otte undersøgelser så på virkningen af at tilføje Abilify eller placebo til eksisterende behandling med lithium eller valproat (et andet antipsykotisk middel med) hos 384 patienter.
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.
Virkningen af Abilify injektionsvæske, opløsning, blev sammenlignet med lorazepam (et andet antipsykotisk middel) og placebo i en periode på to timer i en undersøgelse af 301 patienter med bipolar lidelse, som havde urosymptomer.
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.
Alle undersøgelserne så på ændringen i symptomerne efter en standardskala for bipolar lidelse eller antallet af patienter, der responderede på behandlingen.
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.
Virksomheden udførte desuden undersøgelser af absorptionen af smeltetabletterne og den orale opløsning.
The company also carried out studies looking at the absorption of the orodispersible tablets and oral solution by the body.
Abilify var mere effektivt end placebo til behandling af skizofreni i korttidsundersøgelserne.
When used to treat schizophrenia, Abilify was more effective than placebo in the short-term studies.
I langtidsundersøgelserne var Abilify efter et års behandling mere effektivt end placebo og lige så effektivt som haloperidol.
In the long-term studies, Abilify was more effective than placebo, and as effective as haloperidol, after up to a year of treatment.
I begge undersøgelser af injektionsvæsken var mindskelsen af urosymptomer væsentligt større hos de patienter, der fik Abilify i doser på 5, 25, 9, 75 eller 15 mg, end hos dem, der fik injektioner af placebo.
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.
Ved behandling af bipolar lidelse var Abilify mere effektivt end placebo til at mindske maniske symptomer i fire af de fem korttidsundersøgelser.
When used to treat bipolar disorder, Abilify was more effective than placebo at reducing manic symptoms in four of the five short-term studies.
Abilifys virkning svarede til haloperidol og lithium i en tre ugers periode.
Abilify also had a similar effect to haloperidol and to lithium over three weeks.
Denne virkning blev fastholdt i indtil 12 uger.
This effect was maintained for up to 12 weeks.
Abilify var også mere effektivt end placebo til at forebygge mod tilbagevendende maniske episoder hos tidligere behandlede patienter i indtil 74 uger, og når det blev anvendt som en tillægsbehandling til eksisterende behandling.
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.
Injektioner af Abilify i doser på 10 eller 2/ 3 15 mg var også mere effektive end placebo til at mindske urosymptomerne og svarede til virkningen af lorazepam
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.
Hvilken risiko er der forbundet med Abilify?
2/ 3 What is the risk associated with Abilify?
De mest almindelige bivirkninger ved indtagelse af Abilify gennem munden (set hos mellem 1 og 10 patienter ud af hver 100) er ekstrapyramidal lidelse (spjættende eller rykkende bevægelser, der ikke kan kontrolleres), akatisi (manglende evne til at sidde stille), rystelser, søvntrang, sløvhed, hovedpine, sløret syn, halsbrand, opkastning, kvalme, forstoppelse, øget dannelse af spyt, træthed, rastløshed, søvnbesvær og ængstelse.
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.
Akatisi er mere almindelig hos patienter med bipolar lidelse end hos patienter med skizofreni.
Akathisia is more common in patients with bipolar disorder than in those with schizophrenia.
Blandt de patienter, der fik injektioner af Abilify, oplevede mellem 1 og 10 patienter af 100 søvntrang, svimmelhed, hovedpine, akatisi, kvalme og opkastning.
Between 1 and 10 patients in 100 receiving injections of Abilify experience somnolence, dizziness, headache, akathisia, nausea and vomiting.
Den fuldstændige liste over de indberettede bivirkninger ved Abilify fremgår af indlægssedlen.
For the full list of all side effects reported with Abilify, see the Package Leaflet.
Abilify bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for aripiprazol eller nogen af indholdsstofferne.
Abilify should not be used in people who may be hypersensitive (allergic) to aripiprazole or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Abilify opvejer risiciene til behandling af skizofreni og af moderate til svære maniske episoder ved bipolar lidelse type 1 og til forebyggelse af ny manisk episode hos patienter, der har oplevet hovedsageligt maniske episoder og som i maniske episoder har responderet på behandling med aripiprazol.
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.
Udvalget fandt desuden, at fordelene ved injektionsvæsken opvejer risiciene til hurtig kontrol af uro og forstyrret adfærd hos patienter med skizofreni eller maniske episoder hos patienter med bipolar lidelse af type 1, når oral behandling ikke er hensigtsmæssig.
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.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Abilify.
The Committee recommended that Abilify be given marketing authorisation.
Andre oplysninger om Abilify:
Other information about Abilify:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Abilify til Otsuka Pharmaceutical Europe Ltd. den 4. juni 2004.
The European Commission granted a marketing authorisation valid throughout the European Union for Abilify to Otsuka Pharmaceutical Europe Ltd. on 4 June 2004.
Den fuldstændige EPAR for Abilify findes her.
The full EPAR for Abilify can be found here.
Dette sammendrag blev sidst ajourført i 07- 2008.
This summary was last updated in 07-2008.
EU- nummer
EU Number
Særnavn
Strength
Styrke
Tablet
Lægemiddelform
EU/ 1/ 04/ 276/ 015
Indgivelsesvej
EU/ 1/ 04/ 276/ 016
Emballage
Abilify
Indhold
Oral use
Pakningsstørrelse
1/ 2 EU/ 1/ 04/ 276/ 017
EU/ 1/ 04/ 276/ 001 EU/ 1/ 04/ 276/ 002 EU/ 1/ 04/ 276/ 003 EU/ 1/ 04/ 276/ 004 EU/ 1/ 04/ 276/ 005 EU/ 1/ 04/ 276/ 006 EU/ 1/ 04/ 276/ 007 EU/ 1/ 04/ 276/ 008 EU/ 1/ 04/ 276/ 009 EU/ 1/ 04/ 276/ 010 EU/ 1/ 04/ 276/ 011 EU/ 1/ 04/ 276/ 012 EU/ 1/ 04/ 276/ 013 EU/ 1/ 04/ 276/ 014 EU/ 1/ 04/ 276/ 015 EU/ 1/ 04/ 276/ 016 EU/ 1/ 04/ 276/ 017 EU/ 1/ 04/ 276/ 018 EU/ 1/ 04/ 276/ 019 EU/ 1/ 04/ 276/ 020 EU/ 1/ 04/ 276/ 024 EU/ 1/ 04/ 276/ 025 EU/ 1/ 04/ 276/ 026 EU/ 1/ 04/ 276/ 027 EU/ 1/ 04/ 276/ 028 EU/ 1/ 04/ 276/ 029 EU/ 1/ 04/ 276/ 030 EU/ 1/ 04/ 276/ 031 EU/ 1/ 04/ 276/ 032
Oral use
Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify Abilify
15 mg
5 mg 5 mg 5 mg 5 mg 5 mg 10 mg 10 mg 10 mg 10 mg 10 mg 15 mg 15 mg 15 mg 15 mg 15 mg 30 mg 30 mg 30 mg 30 mg 30 mg 10 mg 10 mg 10 mg 15 mg 15 mg 15 mg 30 mg 30 mg 30 mg
unit dose perforated blister (alu/ alu)
Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Tabletter Smeltetabletter Smeltetabletter Smeltetabletter Smeltetabletter Smeltetabletter Smeltetabletter Smeltetabletter Smeltetabletter Smeltetabletter
unit dose perforated blister (alu/ alu)
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Orodispersible Tablet
Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips( alu/ alu) Blisterstrips (alu/ alu) Blisterstrips (alu/ alu) Blisterstrips (alu/ alu) Blisterstrips (alu/ alu) Blisterstrips (alu/ alu) Blisterstrips (alu/ alu) Blisterstrips (alu/ alu) Blisterstrips (alu/ alu) Blisterstrips (alu/ alu)
Abilify
14 x 1 28 x 1 49 x 1 56 x 1 98 x 1 14 x 1 28 x 1 49 x 1 56 x 1 98 x 1 14 x 1 28 x 1 49 x 1 56 x 1 98 x 1 14 x 1 28 x 1 49 x 1 56 x 1 98 x 1 14 x 1 28 x 1 49 x 1 14 x 1 28 x 1 49 x 1 14 x 1 28 x 1 49 x 1
unit dose perforated blister (alu/ alu)
EU/ 1/ 04/ 276/ 033
EU/ 1/ 04/ 276/ 031
1 mg/ ml
49 x 1
Flaske (PET)
bottle (PET)
1 flaske + 1 bæger + 1 kalibreret pipette
1 bottle + 1 cup + 1 calibrated dropper
Hætteglas (glas)
vial (glass)
67 mg lactose per tablet.
67 mg lactose per tablet
Tablet Rektangulær og blå, graveret med ” A- 007” og ” 5 ” på den ene side.
Tablet Rectangular and blue, engraved with "A-007" and "5" on one side.
4. 1 Terapeutiske indikationer
4.1 Therapeutic indications
ABILIFY er indiceret til behandling af skizofreni.
ABILIFY is indicated for the treatment of schizophrenia.
5. 1).
ABILIFY is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1).
4. 2 Dosering og indgivelsesmåde
4.2 Posology and method of administration
Skizofreni:
Schizophrenia:
Den anbefalede startdosis for ABILIFY er 10- 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.
ABILIFY is effective in a dose range of 10 to 30 mg/ day.
Maniske episoder:
Manic episodes:
5. 1).
The recommended starting dose for ABILIFY is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy (see section 5.1).
Forebyggelse af recidiv af maniske episoder ved bipolar lidelse type 1:
Recurrence prevention of manic episodes in Bipolar I Disorder:
Til forebyggelse af recidiv af maniske episoder hos patienter, der har været behandlet med aripiprazol, fortsættes behandlingen i samme dosis.
For preventing recurrence of manic episodes in patients who have been receiving aripiprazole, continue therapy at the same dose.
Justering af daglig dosis, inklusive dosisreduktioner, bør overvejes på baggrund af klinisk status.
Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status.
Der er ingen erfaring med behandling af børn og unge under 18 år.
Children and adolescents: there is no experience in children and adolescents under 18 years of age.
Dosisjustering til patienter med mild til moderat leverinsufficiens er ikke påkrævet.
Patients with hepatic impairment: no dosage adjustment is required for patients with mild to moderate hepatic impairment.
Den
However, the
5. 2).
2 maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
Dosisjustering til patienter med nedsat nyrefunktion er ikke påkrævet.
Patients with renal impairment: no dosage adjustment is required in patients with renal impairment.
Virkning af ABILIFY ved behandling af skizofreni og bipolar lidelse type 1 hos patienter på 65 år eller derover er ikke undersøgt.
Elderly: the effectiveness of ABILIFY in the treatment of schizophrenia and Bipolar I Disorder in patients 65 years of age or older has not been established.
4. 4).
Owing to the greater sensitivity of this population, a lower starting dose should be considered when clinical factors warrant (see section 4.4).
5. 2).
Gender: no dosage adjustment is required for female patients as compared to male patients (see section 5.2).
4. 5).
Smoking status: according to the metabolic pathway of ABILIFY no dosage adjustment is required for smokers (see section 4.5).
Ved samtidig administration af potente CYP3A4 - eller CYP2D6- hæmmere og aripiprazol, bør dosis af aripiprazol nedsættes.
When concomitant administration of potent CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, the aripiprazole dose should be reduced.