natgillin/translations-raw huggingface dataset:
4. 5).
When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased (see section 4.5).
Ved samtidig administration af potente CYP3A4- induktorer og aripiprazol, bør dosis af aripiprazol øges.
When concomitant administration of potent CYP3A4 inducers with aripiprazole occurs, the aripiprazole dose should be increased.
4. 5).
When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should then be reduced to the recommended dose (see section 4.5).
4. 3 Kontraindikationer
4.3 Contraindications
4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
4.4 Special warnings and precautions for use
4. 8).
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).
Høj- risikopatienter bør overvåges tæt under antipsykotisk behandling..
Close supervision of high-risk patients should accompany antipsychotic therapy.
Resultater fra en epidemiologisk undersøgelse viste, at der ikke var en øget risiko for selvmord med aripiprazol sammenlignet med andre antispsykotika, hos patienter med bipolar lidelse.
Results of an epidemiological study found that there was no increased risk of suicidality with aripiprazole compared to other antipsychotics among patients with bipolar disorder.
Kardiovaskulære sygdomme:
Cardiovascular disorders:
Aripiprazol bør anvendes med forsigtighed til patienter med kendt kardiovaskulær sygdom (anamnestisk myokardieinfarkt eller iskæmisk hjertesygdom, hjertesvigt eller ledningsforstyrrelser), cerebrovaskulær sygdom, tilstande som disponerer for hypotension (dehydrering, hypovolæmi og behandling med antihypertensiva) eller hypertension, accelereret såvel som malign.
Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications) or hypertension, including accelerated or malignant.
Ledningsforstyrrelser:
Conduction abnormalities:
Hyppighed af QT- forlængelse var i kliniske forsøg med aripiprazol sammenlignelig med placebo.
In clinical trials of aripiprazole, the incidence of QT prolongation was comparable to placebo.
Som med andre antipsykotika bør aripiprazol anvendes med forsigtighed til patienter med arvelig QT- forlængelse.
As with other antipsychotics, aripiprazole should be used with caution in patients with a family history of QT prolongation.
I kliniske forsøg, af en varighed på et år eller kortere, er der kun sjældent indberettet behandlingsbetingede dyskinesier under behandling med aripiprazol.
Tardive Dyskinesia: in clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
Hvis der fremkommer symptomer på tardiv dyskinesi hos en patient, der behandles med ABILIFY, skal dosisreduktion eller afbrydelse overvejes.
If signs and symptoms of tardive dyskinesia appear in a patient on ABILIFY, dose reduction or discontinuation should be considered.
Neuroleptisk Malignt Syndrom (NMS):
Neuroleptic Malignant Syndrome (NMS):
NMS er et potentielt fatalt symptomkompleks forbundet med antipsykotiske lægemidler.
NMS is a potentially fatal symptom complex associated with antipsychotic medicinal products.
Der har i kliniske forsøg været sjældne rapporter om NMS under
In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
3 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).
3 mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Yderligere tegn kan omfatte forhøjet kreatinfosfokinase, myoglobinuri (rhabdomyolyse) og akut nyresvigt.
Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Forhøjet kreatinfosfokinase og rhabdomyolose, der ikke nødvendigvis er forbundet med NMS, er dog også rapporteret.
However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported.
Hvis patienten udvikler symptomer på NMS, eller uforklarligt får høj feber uden andre kliniske manifestationer på NMS, skal alle antipsykotiske lægemidler, inklusive ABILIFY, seponeres.
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicinal products, including ABILIFY, must be discontinued.
Der er i kliniske forsøg rapporteret sjældne tilfælde af kramper under behandling med aripiprazol.
Seizure: in clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole.
Aripiprazol skal dog anvendes med forsigtighed til patienter, der tidligere har haft kramper eller har sygdom forbundet med kramper.
Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures.
Ældre patienter med demensrelaterede psykoser:
Elderly patients with dementia-related psychosis:
I tre placebo- kontrollerede forsøg (n= 938; gennemsnitsalder:
Increased mortality: in three placebo-controlled trials (n= 938; mean age:
82, 4 år; aldersspænd:
82.4 years; range:
56- 99 år) med ældre patienter med psykose i forbindelse med Alzheimer- sygdom sås øget risiko for dødsfald hos patienter behandlet med aripiprazol sammenlignet med placebo.
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.
Dødeligheden var 3, 5% blandt aripiprazol- behandlede patienter sammenlignet med 1, 7% i placebogruppen.
The rate of death in aripiprazole-treated patients was 3.5% compared to 1.7% in the placebo group.
Selv om dødsårsagerne var forskellige, havde de fleste dødsfald cerebrovaskulære (fx hjertesvigt, pludselig død) eller infektiøse årsager (fx lungebetændelse).
Although the causes of deaths were varied, most of the deaths appeared to be either cardiovascular (e. g. heart failure, sudden death) or infectious (e. g. pneumonia) in nature.
Der er i de samme forsøg rapporteret cerebrovaskulære bivirkninger (fx apopleksi og transitorisk iskæmi (TIA)) samt dødsfald hos patienter (gennemsnitsalder:
Cerebrovascular adverse events: in the same trials, cerebrovascular adverse events (e. g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age:
84 år; aldersspænd:
84 years; range:
78- 88 år).
78-88 years).
Der er ialt indberettet cerebrovaskulære bivirkninger hos 1, 3% af de aripiprazol- behandlede patienter i forsøgene sammenlignet med 0, 6% af de placebo- behandlede.
Overall, 1.3% of aripiprazole-treated patients reported cerebrovascular adverse events compared with 0.6% of placebo-treated patients in these trials.
I et af disse forsøg, et forsøg med fast dosis, sås signifikant dosis- responsforhold for cerebrovaskulære bivirkninger hos aripiprazol- behandlede patienter.
However, in one of these trials, a fixed-dose trial, there was a significant dose response relationship for cerebrovascular adverse events in patients treated with aripiprazole.
ABILIFY er ikke godkendt til behandling af demensrelateret psykose.
ABILIFY is not approved for the treatment of dementia-related psychosis.
Der er indberettet hyperglykæmi, i nogle tilfælde udtalt og relateret til ketoacidose eller hyperosmolær koma eller død, hos patienter i behandling med atypiske antipsykotika, inklusive ABILIFY.
Hyperglycaemia and Diabetes Mellitus: hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotic agents, including ABILIFY.
I kliniske undersøgelser med aripiprazol sås ingen signifikant forskel i forekomst af hyperglykæmirelaterede bivirkninger (herunder diabetes) eller i abnorme glykæmiske laboratorieværdier sammenlignet med placebo.
In clinical trials with aripiprazole, there were no significant differences in the incidence rates of hyperglycaemia-related adverse events (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
Præcise risikovurderinger for hyperglykæmirelaterede bivirkninger hos patienter behandlet med ABILIFY eller andre atypiske antipsykotika er ikke tilgængelige til at kunne lave en direkte sammenligning.
Precise risk estimates for hyperglycaemia-related adverse events in patients treated with ABILIFY and with other atypical antipsychotic agents are not available to allow direct comparisons.
Patienter som behandles med antipsykotika, herunder ABILIFY, bør observeres for symptomer for hyperglykæmi (fx polydipsi, polyuri, polyfagi og svækkelse), og patienter med diabetes mellitus, eller med risiko for at udvikle diabetes mellitus, bør monitoreres regelmæssigt med henblik på forværring i glukosekontrollen.
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.
Vægtstigning: vægtstigning er almindeligt forekommede 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.
Der er efter markedsføring indberettet vægtstigning hos patienter behandlet med ABILIFY.
Weight gain has been reported post-marketing among patients prescribed ABILIFY.
Aripiprazol har i kliniske forsøg ikke induceret klinisk relevant vægtstigning (se afsnit 5. 1).
In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain (see section 5.1).
Dysfagi: øsofagusdysmotilitet og aspiration er forbundet med anvendelse af antipsykotika, inklusive ABILIFY.
Dysphagia: oesophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY.
Aripiprazol og andre antipsykotika bør anvendes med forsigtighed hos patienter med risiko for aspirationspneumoni.
Aripiprazole and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.
Lactose: patienter med sjældne arvelige problemer i forbindelse med galaktoseintolerans, lappisk laktasemangel eller glukose- galaktose malabsorption bør ikke anvende dette lægemiddel.
Lactose: patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
4. 8).
Hypersensitivity: as with other medications hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
4 4. 5 Interaktion med andre lægemidler og andre former for interaktion
4 4.5 Interaction with other medicinal products and other forms of interaction
På grund af den α1- adrenerge receptorantagonisme, kan aripiprazol øge virkningen af visse antihypertensive midler.
Due to its α 1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents.
4. 8).
Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is taken in combination with alcohol or other CNS medicinal products with overlapping undesirable effects such as sedation (see section 4.8).
Der skal udvises forsigtighed, hvis aripiprazol administreres samtidig med lægemidler, der vides at forårsage QT- forlængelse eller elektrolytforstyrrelser.
If aripiprazole is administered concomitantly with medicines known to cause QT prolongation or electrolyte imbalance, caution should be used.
Andre lægemidler, der kan påvirke optagelsen af ABILIFY:
Potential for other medicinal products to affect ABILIFY:
Syreblokkeren og H2- antagonisten famotidin nedsætter absorptionshastigheden for aripiprazol, men denne virkning synes ikke klinisk relevant.
A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
Aripiprazol metaboliseres via flere enzymsystemer, der involverer CYP2D6 - og CYP3A4- enzymer, men ikke CYP1A- enzymer.
Aripiprazole is metabolised by multiple pathways involving the CYP2D6 and CYP3A4 enzymes but not CYP1A enzymes.
I et klinisk forsøg med raske personer øgede en potent CYP2D6- hæmmer (quinidin) aripiprazols AUC med 107%, mens Cmax var uforandret.
In a clinical trial in healthy subjects, a potent inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107%, while Cmax was unchanged.
AUC og Cmax for dehydro- aripiprazol, den aktive metabolit, reduceredes med henholdsvis 32% og 47%.
The AUC and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32% and 47%.
ABILIFY- dosis bør halveres ved samtidig administration af ABILIFY og quinidin.
ABILIFY dose should be reduced to approximately one-half of its prescribed dose when concomitant administration of ABILIFY with quinidine occurs.
Andre potente CYP2D6- hæmmere, som fx fluoxetin og paroxetin, kan forventes at have lignende virkninger, og lignende dosisreduktioner bør derfor anvendes.
Other potent inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reductions should therefore be applied.
I et klinisk forsøg med raske forsøgspersoner øgede en potent CYP3A4- hæmmer (ketoconazol) aripiprazols AUC og Cmax med henholdsvis 63% og 37%.
In a clinical trial in healthy subjects, a potent inhibitor of CYP3A4 (ketoconazole) increased aripiprazole AUC and Cmax by 63% and 37%, respectively.
AUC og Cmax for dehydro- aripiprazol øgedes med henholdsvis 77% og 43%.
The AUC and Cmax of dehydro-aripiprazole increased by 77% and 43%, respectively.
Hos langsomme CYP2D6- omsættere kan samtidig brug af potente CYP3A4- hæmmere medføre højere plasmakoncentrationer af aripiprazol end hos ekstensive CYP2D6- omsættere.
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.
Hvis samtidig administration af ketoconazol, eller andre potente CYP3A4 - hæmmere, og ABILIFY overvejes, bør eventuelle fordele opveje potentielle risici for patienten.
When considering concomitant administration of ketoconazole or other potent CYP3A4 inhibitors with ABILIFY, potential benefits should outweigh the potential risks to the patient.
Ved samtidig administration af ketoconazol og ABILIFY bør dosis af ABILIFY halveres.
When concomitant administration of ketoconozole with ABILIFY occurs, ABILIFY dose should be reduced to approximately one-half of its prescribed dose.
Andre potente CYP3A4- hæmmere, som fx itraconazol og HIV- proteasehæmmere, kan forventes at have lignende virkninger, og lignende dosisreduktioner bør derfor anvendes.
Other potent inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors, may be expected to have similar effects and similar dose reductions should therefore be applied.
Ved afbrydelse af behandling med CYP2D6 - eller 3A4- hæmmer, bør dosis af ABILIFY øges til niveauet inden start af den samtidige behandling.
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.
Ved samtidig anvendelse af svage CYP3A4 - (fx diltiazem eller escitalopram) eller CYP2D6- hæmmere og ABILIFY, kan beskeden stigning i koncentrationen af aripiprazol forventes.
When weak inhibitors of CYP3A4 (e. g., diltiazem or escitalopram) or CYP2D6 are used concomitantly with ABILIFY, modest increases in aripiprazole concentrations might be expected.
Efter samtidig behandling med carbamazepin, en potent induktor af CYP3A4, var de geometriske middelværdier for Cmax og AUC for aripiprazol henholdsvis 68% og 73% lavere end, hvis aripiprazol (30 mg) blev givet alene.
Following concomitant administration of carbamazepine, a potent inducer of CYP3A4, the geometric means of Cmax and AUC for aripiprazole were 68% and 73% lower, respectively, compared to when aripiprazole (30 mg) was administered alone.
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.
Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69% and 71% lower, respectively, than those following treatment with aripiprazole alone.
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 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.
John's Wort) may be expected to have similar effects and similar dose increases should therefore be applied.
Ved seponering af potente CYP3A4- induktorer bør dosis af ABILIFY nedsættes til den anbefalede dosis.
Upon discontinuation of potent CYP3A4 inducers, the dosage of ABILIFY should be reduced to the recommended dose.
Ved samtidig administration af valproat eller lithium og aripiprazol sås ingen klinisk signifikant ændring i koncentrationerne af aripiprazol.
5 When either valproate or lithium were administered concomitantly with aripiprazole, there was no clinically significant change in aripiprazole concentrations.
5 Andre lægemidler, der kan påvirkes af ABILIFY:
Potential for ABILIFY to affect other medicinal products:
I kliniske forsøg havde en daglig dosis på 10- 30 mg aripiprazol ingen signifikant effekt på metabolismen af CYP2D6- substrater (dextromethorphan/ 3- methoxymorphinan forholdet), 2C9 (warfarin), 2C19 (omeprazol) og 3A4 (dextromethorphan).
In clinical studies, 10-30 mg/ day doses of aripiprazole had no significant effect on the metabolism of substrates of CYP2D6 (dextromethorphan/ 3-methoxymorphinan ratio), 2C9 (warfarin), 2C19 (omeprazole), and 3A4 (dextromethorphan).
Derudover viste aripiprazol og dehydro - aripiprazol ikke potentiale til at ændre CYP1A2- medieret metabolisme in vitro.
Additionally, aripiprazole and dehydro-aripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro.
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.
4. 6 Graviditet og amning
4.6 Pregnancy and lactation
5. 3).
Animal studies could not exclude potential developmental toxicity (see section 5.3).
Patienterne rådes til at informere lægen, hvis de bliver gravide, eller planlægger at blive gravide, under behandling med aripiprazol.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with aripiprazole.
Aripiprazol udskilles i modermælk hos rotter behandlet under laktation.
Aripiprazole was excreted in the milk of treated rats during lactation.
Det vides ikke, om aripiprazol udskilles i human modermælk.
It is not known whether aripiprazole is excreted in human milk.
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
Som med andre antipsykotika, bør patienterne dog advares mod at betjene farlige maskiner og føre motorkøretøj indtil man er sikker på, hvordan aripiprazol påvirker patienten.
However, as with other antipsychotics, patients should be cautioned about operating hazardous machines, including motor vehicles, until they are reasonably certain that aripiprazole does not affect them adversely.
4. 8 Bivirkninger
4.8 Undesirable effects
Følgende bivirkninger optrådte hyppigere (≥ 1/ 100) end placebo eller blev identificeret som muligvis medicinsk relevante bivirkningsreaktioner (*):
The following undesirable effects occurred more often (≥ 1/ 100) than placebo, or were identified as possibly medically relevant adverse reactions (*):
Hyppigheden af bivirkninger anført nedenfor defineres i henhold til følgende konventioner: almindelig (> 1/ 100, < 1/ 10); ikke almindelig (> 1/ 1. 000, < 1/ 100)
The frequency listed below is defined using the following convention: common (> 1/ 100 ,< 1/10) and uncommon (> 1/1 ,000, < 1/100).
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 *
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):
6 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 6 (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 længerevarende, 26- ugers placebo- kontrolleret forsøg var forekomsten af EPS 19% for aripiprazol- behandlede patienter og 13, 1% for placebo- behandlede patienter.
In a long term 26-week placebo-controlled trial, the incidence of EPS was 19% for aripiprazole-treated patients and 13.1% for placebo-treated patients.
I et andet længerevarende, 26- ugers kontrolleret forsøg var forekomsten af EPS 14, 8% for aripiprazol - behandlede patienter og 15, 1% for olanzapin- behandlede patienter.
In another long-term 26-week controlled trial, the incidence of EPS was 14.8% for aripiprazole-treated patients and 15.1% for olanzapine-treated patients.
Maniske episoder ved bipolar lidelse type 1 - i et 12- ugers, kontrolleret forsøg var forekomsten af EPS 23, 5% for aripiprazol - behandlede patienter og 53, 3% for haloperidol- behandlede patienter.
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.
I et andet 12- ugers forsøg var forekomsten af EPS 26, 6% for patienter aripiprazol- behandlede patienter og 17, 6% for 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.