FrancophonIA/ELRC3.0 huggingface dataset:
English: In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 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.
Danish: I tre placebokontrollerede forsøg (n = 938; gennemsnitsalder: 82,4 år; aldersspænd: 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.
English: The most commonly reported adverse reactions in placebo-controlled trials were akathisia and nausea each occurring in more than 3 % of patients treated with oral aripiprazole.
Danish: De hyppigst rapporterede bivirkninger i placebokontrollerede forsøg var akatisi og kvalme, som hver forekom hos mere end 3 % af de patienter, der blev behandlet med oral aripiprazol.
English: Newborn infants exposed to antipsychotics (including aripiprazole) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Danish: Nyfødte, der har været udsat for antipsykotika (inklusive aripiprazol) under tredje trimester af graviditeten, er i risiko for bivirkninger inkluderende ekstrapyramidale og/eller abstinenssymptomer, som kan variere i sværhedsgrad og varighed efter fødslen.
English: In the placebo-controlled trials, the mean weight gain was 0.4 kg for placebo and 1.6 kg for aripiprazole.
Danish: I de placebokontrollerede forsøg var den gennemsnitlige vægtstigning 0,4 kg for placebo og 1,6 kg for aripiprazol.
English: Aripiprazole exhibited high binding affinity in vitro for dopamine D2 and D3, serotonin 5-HT1A and 5-HT2A receptors and moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha-1 adrenergic and histamine H1 receptors.
Danish: 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-HT2Cog 5-HT7-, alfa 1-adrenerge og histamin H1- receptorer.
English: Aripiprazole Mylan Pharmais used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Danish: Aripiprazole Mylan Pharma bruges til at behandle voksne og unge i alderen 13 år og ældre, som lider af en sygdom, der er forbundet med symptomer som fx at føle sig "høj", en overdreven mængde energi, behov for meget mindre søvn end sædvanligt, meget hurtig tale med et væld af idéer og nogle gange voldsom irritabilitet.
English: If you forget to take your Aripiprazole Mylan Pharma If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.
Danish: Hvis du har glemt at tage Aripiprazole Mylan Pharma Hvis du glemmer en dosis, skal du tage den glemte dosis, når du kommer i tanke om det, men du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Danish: Kliniske manifestationer af NMS er hyperpyreksi, muskelstivhed, ændret mental tilstand og tegn på autonom ustabilitet (uregelmæssig puls eller blodtryk, takykardi, diaforese og hjertearytmi).
English: In the same trials, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78-88 years).
Danish: Der er i de samme forsøg rapporteret cerebrovaskulære bivirkninger (fx apopleksi og transitorisk iskæmi (TIA)) samt dødsfald hos patienter (gennemsnitsalder: 84 år; aldersspænd: 78-88 år).
English: In clinical trials of adolescent patients with bipolar mania, aripiprazole has been shown to be associated with weight gain after 4 weeks of treatment.
Danish: I kliniske studier med unge patienter med bipolær mani er aripiprazol vist at være forbundet med vægtstigning efter 4 ugers behandling.
English: Aripiprazole is the predominant medicinal product moiety in systemic circulation.
Danish: Aripiprazol er den dominerende lægemiddelhalvdel ved systemisk cirkulation.
English: 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 treatment, including treatment with aripiprazole (see section 4.8).
Danish: Psykisk sygdom og humørforstyrrelser er forbundet med selvmordsadfærd, som i nogle tilfælde har været rapporteret kort efter opstart eller ændring af antipsykotisk behandling, inklusive behandling med aripiprazol (se pkt.
English: Aripiprazole demonstrated statistically superior efficacy compared to placebo on the Aberrant Behaviour Checklist Irritability subscale.
Danish: Aripiprazol udviste statistisk overlegen virkning sammenlignet med placebo på Aberrant Behaviour Checklist Irritability-underskalaen.
English: Aripiprazole is not recommended for use in patients with schizophrenia below 15 years of age due to insufficient data on safety and efficacy (see sections 4.8 and 5.1).
Danish: Aripiprazol bør ikke anvendes til børn under 15 år med skizofreni på grund af utilstrækkelig dokumentation for sikkerhed og virkning (se pkt.
English: Congenital anomalies have been reported; however, causal relationship with aripiprazole could not be established.
Danish: Der er rapporteret om medfødte anomalier; der kunne dog ikke konstateres nogen kausal sammenhæng mellem disse og aripiprazol.
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Danish: Der er observeret tilfælde af venøs tromboemboli (VTE) i forbindelse med behandling med antipsykotiske lægemidler.
English: Aripiprazole Mylan Pharma is for oral use.
Danish: Aripiprazole Mylan Pharma er til oral anvendelse.
English: Quinidine and other CYP2D6 inhibitors
Danish: Quinidin og andre CYP2D6-hæmmere
English: Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Danish: Yderligere tegn kan omfatte forhøjet kreatinfosfokinase, myoglobinuri (rabdomyolyse) og akut nyresvigt.
English: The safety and efficacy of aripiprazole in the treatment of schizophrenia or manic episodes in Bipolar I Disorder in patients aged 65 years and older has not been established.
Danish: Sikkerheden ved og virkningen af aripiprazol ved behandling af skizofreni eller maniske episoder ved bipolær lidelse type I hos patienter i alderen 65 år og derover er ikke undersøgt.
English: The mean elimination half-lives for aripiprazole are approximately 75 hours in extensive metabolisers of CYP2D6 and approximately 146 hours in poor metabolisers of CYP2D6.
Danish: Middel-eliminationshalveringstiden for aripiprazol er cirka 75 timer hos ekstensive omdannere via CYP2D6 og cirka 146 timer hos dårlige omdannere.
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}
English: Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including aripiprazole.
Danish: 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 aripiprazol.
English: Aripiprazole was superior to placebo in change from baseline at week 4 and at week 12 on the Y-MRS total score.
Danish: Aripiprazol havde bedre effekt end placebo ved ændring fra baseline ved uge 4 og ved uge 12 målt på total Y-MRS-score.
English: Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in your ability to move and balance, which may lead to falls.
Danish: Aripiprazol kan medføre søvnighed, blodtryksfald, når du rejser dig op, svimmelhed og påvirkning af din evne til at bevæge dig og holde balancen, og det kan medføre fald.
English: The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
Danish: De potentielt alvorlige medicinske symptomer rapporteret er døsighed, forbigående bevidstløshed og ekstrapyramidale symptomer.
English: 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.
Danish: 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.
English: Although there is no information on the effect of haemodialysis in treating an overdose with aripiprazole, haemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.
Danish: Selvom virkningen af hæmodialyse ved overdosering med aripiprazol ikke er undersøgt, er det ikke sandsynligt, at hæmodialyse kan anvendes til behandling af overdosering, da aripiprazol i udstrakt grad bindes til plasmaproteiner.
English: Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is administered in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as sedation (see section 4.8).
Danish: På baggrund af aripiprazols primære CNS-påvirkning, bør der udvises forsigtighed, når aripiprazol administreres i kombination med alkohol eller andre CNS-lægemidler med overlappende bivirkninger, som fx sedering (se pkt.
English: Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
Danish: Du skal fortælle det til din læge med det samme, hvis du tænker eller fornemmer, at du vil gøre skade på dig selv.
English: 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 medicinal products) or hypertension, including accelerated or malignant.
Danish: 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 antihypertensive lægemidler) eller hypertension, accelereret såvel som malign.
English: For patients receiving aripiprazole, the median time to onset was 30 days and median duration was 194 days.
Danish: Hos de patienter, der fik aripiprazol, var mediantiden til debut 30 dage og medianvarigheden 194 dage.
English: Warnings and precautions Talk to your doctor before taking Aripiprazole Mylan Pharma
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Aripiprazole Mylan Pharma.
English: 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 5-HT1A receptors and antagonism of serotonin 5-HT2A receptors.
Danish: Det er foreslået, at aripiprazols virkning på skizofreni og bipolær lidelse type I medieres gennem en kombination af partiel agonisme på dopamin D2- og serotonin 5-HT1A-receptorer samt antagonisme på serotonin 5-HT2A-receptorer.
English: • This medicine has been prescribed for you only.
Danish: Lægen har ordineret dette lægemiddel til dig personligt.
English: Each tablet of 5, 10, 15, 30 mg containing 5, 10, 15, 30 mg of aripiprazole respectively.
Danish: Hver tablet indeholder henholdsvis 5, 10, 15, 30 mg aripiprazol.
English: Mylan S.A.S, 117, Allée des Parcs, 69800 Saint-Priest, France
Danish: 117, Allee des Parcs 69800 Saint-Priest Frankrig
English: The potentially medically important signs and symptoms observed included lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea.
Danish: De observerede, potentielt vigtige medicinske tegn og symptomer omfatter lethargi, blodtryksstigning, døsighed, takykardi, kvalme, opkastninger og diarré.
English: Aripiprazole is metabolised by multiple pathways involving the CYP2D6 and CYP3A4 enzymes but not CYP1A enzymes.
Danish: Aripiprazol metaboliseres via flere enzymsystemer, der involverer CYP2D6- og CYP3A4-enzymer, men ikke CYP1A-enzymer.
English: Medicines that increase the level of serotonin are typically used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine and pain:
Danish: Medicin, der øger niveauet af serotonin, bruges typisk til behandling af lidelser som depression, generaliseret angst, OCD (obsessiv-kompulsiv tilstand) og social fobi samt migræne og smerter:
English: • acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
Danish: Akut forvirring, krampeanfald (epilepsi), koma, en kombination af feber, hurtig vejrtrækning, svedtendens,
English: Toxicologically significant effects were observed only at doses or exposures that were sufficiently in excess of the maximum human dose or exposure, indicating that these effects were limited or of no relevance to clinical use.
Danish: Der er kun observeret signifikante toksikologiske virkninger ved doser eller optagelse, der i væsentlig grad overstiger den maksimale humane eksponering eller optagelse.
English: In a pooled analysis on lipid parameters from placebo controlled clinical trials in adults, aripiprazole has not been shown to induce clinically relevant alterations in levels of total cholesterol, triglycerides, HDL and LDL.
Danish: I en samlet analyse af lipidparametre fra placebokontrollerede kliniske forsøg med voksne har aripiprazol vist ikke at inducere klinisk relevante ændringer i totalkolesterol, triglycerider, HDL og LDL.
English: Aripiprazole doses ranging from 0.5 to 30 mg administered once a day to healthy subjects for 2 weeks produced a dose-dependent reduction in the binding of 11C-raclopride, a D2/D3 receptor ligand, to the caudate and putamen detected by positron emission tomography.
Danish: Ved administration af aripiprazoldoser i intervallet 0,5-30 mg, én gang dagligt til raske personer i 2 uger, sås dosisafhængig reduktion i bindingen af 11C-racloprid, en D2/D3-receptorligand til caudatus og putamen påvist ved positronemissionstomografi.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from aripiprazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med aripiprazol seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: BGP Products ApS Tel: +45 28116932 (Danmörk)
Danish: BGP Product ApS Tel: +45 28116932 (Danmörk)
English: In addition, cases of stroke or "mini" stroke have been reported.
Danish: Derudover er der indberettet slagtilfælde eller forbigående slagtilfælde.
English: The rate of death in aripiprazole-treated patients was 3.5 % compared to 1.7 % in the placebo group.
Danish: Dødeligheden var 3,5 % blandt aripiprazol-behandlede patienter sammenlignet med 1,7 % i placebogruppen.
English: Concomitant administration of aripiprazole and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects and similar dose increases should therefore be applied.
Danish: Samtidig administration af aripiprazol og andre CYP3A4-induktorer (fx rifampicin, rifabutin, fenytoin, fenobarbital, primidon, efavirenz, nevarapin og perikum) kan forventes at have lignende virkninger, og lignende dosisøgninger bør derfor anvendes.
English: The Kaplan-Meier rates for recurrence to any mood episode for the adjunctive treatment arm were 16 % in aripiprazole + lithium and 18 % in aripiprazole + valproate compared to 45 % in placebo + lithium and 19 % in placebo + valproate.
Danish: Kaplan-Meier recidivrate for alle stemningsepisoder i armen med tillægsbehandling var 16 % for aripiprazol + lithium og 18 % for aripiprazol + valproat sammenlignet med 45 % for placebo + lithium og 19 % for placebo + valproat.
English: The most common treatment-emergent adverse events among patients receiving 30 mg were extrapyramidal disorder (28.3 %), somnolence (27.3 %), headache (23.2 %), and nausea (14.1 %).
Danish: De hyppigst forekommende behandlingskrævende bivirkninger hos patienter, behandlet med 30 mg, var ekstrapyramidale symptomer (28,3 %), døsighed (27,3 %), hovedpine (23,2 %) og kvalme (14,1 %).
English: Consider dose reduction or stopping the medication if a patient develops such urges while taking aripiprazole (see section 4.8).
Danish: Overvej dosisreduktion eller seponering af lægemidlet, hvis en patient udvikler en sådan adfærd under behandling med aripiprazol (se pkt.
English: 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.
Danish: Vægtstigning er almindeligt forekommende hos patienter med skizofreni og bipolær sygdom pga. samtidige sygdomme, anvendelse af antipsykotika der vides at forårsage vægtstigning og dårlig livsstil og kan medføre alvorlige komplikationer.
English: 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 (see section 4.8).
Danish: Selv om dødsårsagerne var forskellige, havde de fleste dødsfald cerebrovaskulære (fx hjertesvigt, pludselig død) eller infektiøse årsager (fx lungebetændelse) (se pkt.
English: Aripiprazole should be used with caution in patients with a family history of QT prolongation (see section 4.8).
Danish: Aripiprazol bør anvendes med forsigtighed til patienter med en familieanamnese med QTforlængelse (se pkt.
English: Enhanced efficacy at doses higher than a daily dose of 15 mg has not been demonstrated although individual patients may benefit from a higher dose.
Danish: Der er ikke påvist forbedret effekt ved doser over 15 mg dagligt, selvom individuelle patienter kan have gavn af en højere dosis.
English: In a clinical trial in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107 %, while Cmax was unchanged.
Danish: I et klinisk forsøg med raske personer øgede en stærk CYP2D6-hæmmer (quinidin) aripiprazols AUC med 107 %, mens Cmax var uforandret.
English: Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reductions should therefore be applied.
Danish: Andre stærke CYP2D6-hæmmere, som fx fluoxetin og paroxetin, kan forventes at have lignende virkninger, og lignende dosisreduktioner bør derfor anvendes.
English: Enhanced efficacy at doses higher than a daily dose of 10 mg has not been demonstrated, and a daily dose of 30 mg is associated with a substantially higher incidence of significant adverse reactions including EPS related events, somnolence, fatigue and weight gain (see section 4.8).
Danish: Der er ikke påvist forbedret virkning ved doser over 10 mg dagligt, og en daglig dosis på 30 mg er associeret med en betydelig højere forekomst af signifikante bivirkninger, herunder ekstrapyramidale symptomer, døsighed, træthed og vægtstigning (se pkt.
English: In a 26-week, placebo-controlled trial in adult stabilised patients with chronic schizophrenia, aripiprazole had significantly greater reduction in relapse rate, 34 % in aripiprazole group and 57 % in placebo.
Danish: I et 26-ugers, placebokontrolleret forsøg med voksne stabiliserede patienter med kronisk skizofreni var aripiprazol forbundet med en signifikant større reduktion i tilbagefaldsraten; 34 % i aripiprazolgruppen og 57 % i placebo.
English: Pharmathen S.A. 6, Dervenakion Pallini 15351 Attiki,
Danish: Pharmathen S.A. 6, Dervenakion Pallini 15351
English: In contrast the 95 % confidence interval for the HR in the older subgroup (aripiprazole, n = 69; placebo, n = 36) was 0.242 to 0.879 and hence a treatment effect could be concluded in the older patients.
Danish: Derimod var konfidensintervallet for hazard ratioen i den ældste delgruppe (aripiprazol, n = 69; placebo, n = 36) 0,242-0,879, og derfor kunne der konstateres en behandlingseffekt blandt de ældste patienter.
English: For patients receiving aripiprazole, the median time to onset was 42 days and median duration was 34 days.
Danish: Hos de patienter, der fik aripiprazol, var mediantiden til debut 42 dage og medianvarigheden 34 dage.
English: Patients treated with any antipsychotic, including aripiprazole, 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 (see section 4.8).
Danish: Patienter som behandles med antipsykotika, herunder aripiprazol, 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 dårligere glucosekontrol (se pkt.
English: 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.
Danish: 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 middelsteady-state AUC ved maksimal, anbefalet klinisk dosis.
English: Aripiprazole showed an improvement on TTS-YGTSS change from baseline to week 8 of 13.35, for the low dose group (5 mg or 10 mg) and 16.94 for the high dose group (10 mg or 20 mg) as compared with an improvement of 7.09 in the placebo group.
Danish: Aripiprazol gav en TTS-YGTSS-forbedring fra baseline til uge 8 på 13,35 i lavdosisgruppen (5 mg eller 10 mg) og på 16,94 i højdosisgruppen (10 mg eller 20 mg); til sammenligning var forbedringen i placebogruppen på 7,09.
English: If signs and symptoms of other EPS appear in a patient taking aripiprazole, dose reduction and close clinical monitoring should be considered.
Danish: Hvis der fremkommer symptomer på andre ekstrapyramidale symptomer hos en patient, der behandles med Aripiprazole Mylan Pharma, skal dosisreduktion og tæt klinisk monitorering overvejes.
English: Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalysed by CYP3A4.
Danish: Baseret på in vitro-forsøg er CYP3A4 og CYP2D6 ansvarlige for dehydrogenering og hydroxylering af aripiprazol, og N-dealkylering katalyseres ved CYP3A4.
English: Carbamazepine and other CYP3A4 inducers
Danish: Carbamazepin og andre CYP3A4-induktorer
English: Adjunctive aripiprazole demonstrated superiority over placebo on the secondary outcome measure, CGI-BP Severity of Illness score (mania).
Danish: Aripiprazol som tillægsbehandling viste superioritet i forhold til placebo for det sekundære endepunkt CGI-BP Severity of Illness score (mani).