natgillin/translations-raw huggingface dataset:
På grund af den α1-adrenerge receptorantagonisme, kan aripiprazol øge virkningen af visse antihypertensive lægemidler.
Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.
Aripiprazol blev også undersøgt i et placebokontrolleret, langvarigt vedligeholdelsesstudie.
Aripiprazole was also studied in a placebo-controlled, long-term maintenance trial.
Køn Dosisjustering til kvindelige patienter i forhold til mandlige patienter er ikke påkrævet (se pkt.
Gender No dosage adjustment is required for female patients as compared to male patients (see section 5.2).
Blodtrykssænkende medicin: Aripiprazole Mylan Pharma kan forstærke virkningen af medicin, der bruges til at sænke blodtrykket.
Blood pressure-lowering medicines: Aripiprazole Mylan Pharma may increase the effect of medicines used to lower the blood pressure.
Pludselig, uforklarlig død Torsades de pointes QT-forlængelse Ventrikulære arytmier Hjertestop
Sudden unexplained death Torsades de pointes QT prolongation Ventricular arrhythmias Cardiac arrest Bradycardia
Risikofaktorer, der kan disponere patienterne for alvorlige komplikationer, omfatter overvægt og arvelig diabetes.
Risk factors that may predispose patients to severe complications include obesity and family history of diabetes.
Kontakt lægen, hvis du tager medicin for dit blodtryk.
Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.
Patienter kan opleve forskellige former for øget trang, især til hasardspil, og manglende evne til at styre denne trang, når de tager aripiprazol.
Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking aripiprazole.
på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Forhøjet kreatinfosfokinase og rabdomyolyse, 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.
Aripiprazol viser også moderat bindingsaffinitet for serotonin-reuptake site og ingen væsentlig affinitet for muscarine receptorer.
Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for muscarinic receptors.
Farmakoterapeutisk klassifikation: Psykoleptika, andre antipsykotika, ATC-kode: N05AX12
Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12
Øsofageal dysmotilitet og aspiration har været forbundet med brug af antipsykotika, herunder aripiprazol.
Oesophageal dysmotility and aspiration have been associated with the use of antipsychotics, including aripiprazole.
Brug af Aripiprazole Mylan Pharma sammen med mad, drikke og alkohol Dette lægemiddel kan tages uafhængigt af måltider.
Aripiprazole Mylan Pharma with food, drink and alcohol This medicine can be taken regardless of meals.
Håndtering af overdosering bør omfatte understøttende behandling, opretholdelse af frie luftveje, ilt og ventilering samt behandling af symptomerne.
Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
Aripiprazol absorberes godt, med maksimal plasmakoncentration inden for 3-5 timer efter administration.
Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3-5 hours after dosing.
Aripiprazol metaboliseres hovedsageligt i leveren via tre biotransformationsveje: dehydrogenering, hydroxylering og N-dealkylering.
Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation.
Depression Hyperseksualitet
Depression, Hypersexuality
Stabiliserede patienter blev herefter randomiseret til at fortsætte med at tage den samme stemningsstabilisator med dobbeltblind aripiprazol eller placebo.
Stabilized patients were then randomised to continue the same mood stabilizer with double-blind aripiprazole or placebo.
I en post hoc-analyse var forbedringen versus placebo mere udtalt hos patienter med associeret ADHD som co-morbiditet sammenlignet med gruppen uden ADHD, hvor der ikke var nogen forskel sammenlignet med placebo.
In a post-hoc analysis, the improvement over placebo was more pronounced in the patients with associated co-morbidity of ADHD compared to the group without ADHD, where there was no difference from placebo.
Selvom du føler du har det bedre, må du ikke ændre eller lade være med at tage den daglige dosis af Aripiprazole Mylan Pharma uden først at have kontaktet lægen.
Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Mylan Pharma without first consulting your doctor.
Dato for første markedsføringstilladelse: 30. juni 2015 Dato for seneste fornyelse:
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 June 2015
Forsøg at tage Aripiprazole Mylan Pharma på samme tidspunkt hver dag.
Try to take Aripiprazole Mylan Pharma at the same time each day.
Hos voksne forebygger det også, at tilstanden vender tilbage hos patienter, der har haft god effekt af behandling med Aripiprazole Mylan Pharma.
In adults it also prevents this condition from returning in patients who have responded to the treatment with Aripiprazole Mylan Pharma.
Serotoninsyndrom
Serotonin syndrome
Valproat og litium
Valproate and lithium
Det er derfor ikke sandsynligt, at aripiprazol kan forårsage klinisk relevant lægemiddelinteraktion medieret ved disse enzymer.
Thus, aripiprazole is unlikely to cause clinically important medicinal product interactions mediated by these enzymes.
Ved steady-state repræsenterer dehydro-aripiprazol, den aktive metabolit, omkring 40 % af aripiprazol AUC i plasma.
At steady state, dehydro-aripiprazole, the active metabolite, represents about 40% of aripiprazole AUC in plasma.
Ved terapeutiske koncentrationer bindes aripiprazol og dehydro-aripiprazol mere end 99 % til serumproteiner, primært til albumin.
At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99 % bound to serum proteins, binding primarily to albumin.
Dosis kan gradvist øges til den anbefalede dosis for unge på 10 mg dagligt.
The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day.
Aripiprazol kan medføre somnolens, postural hypotension, motorisk og sensorisk ustabilitet, som kan medføre fald.
Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls.
Aripiprazol er effektivt til at opretholde klinisk forbedring under fortsættelsesbehandling hos voksne patienter med respons på den indledende behandling.
Aripiprazole is effective in maintaining the clinical improvement during continuation therapy in adult patients who have shown an initial treatment response.
Hvis patienten udvikler symptomer på NMS, eller uforklarligt får høj feber uden andre kliniske manifestationer på NMS, skal alle antipsykotika, inklusive aripiprazol, seponeres.
If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotics, including aripiprazole, must be discontinued.
Fire subgrupper blev undersøgt i den randomiserede fase: aripiprazol + lithium, aripiprazol + valproat; placebo + lithium; placebo + valproat.
Four mood stabilizer subgroups were assessed in the randomised phase: aripiprazole + lithium; aripiprazole + valproate; placebo + lithium; placebo + valproate.
Tardiv dyskinesi
Tardive dyskinesia
Aripiprazole Mylan Pharma indeholder det aktive stof aripiprazol, som tilhører en gruppe af lægemidler, der kaldes antipsykotika.
Aripiprazole Mylan Pharma contains the active substance aripiprazole and belong to a group of medicines called antipsychotics.
Klasseeffekt - der kan forekomme symptomer på dystoni, længerevarende anormale sammentrækninger af muskelgrupper hos modtagelige individer i de første par dage af behandlingen.
Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
I studier med gentagne doser hos juvenile rotter og hunde var toksicitetsprofilen af aripiprazol sammenlignelig med den, der blev observeret hos voksne dyr, og der var intet, der tydede på neurotoksicitet eller bivirkninger på udviklingen.
In repeat-dose studies in juvenile rats and dogs, the toxicity profile of aripiprazole was comparable to that observed in adult animals, and there was no evidence of neurotoxicity or adverse reactions on development.
I den pædiatriske population blev der hyppigere observeret døsighed og træthed hos patienter med bipolær lidelse end hos patienter med skizofreni.
In the paediatric population somnolence and fatigue were observed more frequently in patients with bipolar disorder compared to patients with schizophrenia.
I delgruppeanalyserne var punktestimatet for hazard ratioen 0,495 hos patienter i alderen 13-14 år og 0,454 hos patienter i alderen 15-17 år.
In subgroup analyses the point estimate of the HR was 0.495 for subjects 13 to 14 years of age compared to 0.454 for subjects 15 to 17 years of age.
Aripiprazol er ikke indiceret til behandling af patienter med demensrelateret psykose.
Aripiprazole is not indicated for the treatment of patients with dementia-related psychosis.
Hvis du er ældre og lider af demens (hukommelsestab og tab af andre mentale evner), skal din familie eller din kontaktperson informere lægen om eventuelle slagtilfælde eller forbigående slagtilfælde.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke.
Bivirkningerne er opstillet efter systemorganklasse og hyppighed; meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
All ADRs are listed by system organ class and frequency; very common (≥ 1 /10), common (≥ 1/100 to< 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Aripiprazol bør anvendes med forsigtighed hos patienter med risiko for aspirationspneumoni.
Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia.
Aripiprazol fordeles i stor udstrækning, med et faktisk fordelingsvolumen på 4,9 l/kg, indikerende omfattende ekstravaskulær fordeling.
Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/kg, indicating extensive extravascular distribution.
Patienterne blev stabiliseret i mindst 12 konsekutive uger med kombinationsbehandling med aripiprazol og den samme stemningsstabilisator.
Patients were stabilised for at least 12 consecutive weeks with the combination of aripiprazole and the same mood stabilizer.
På grund af den øgede følsomhed hos denne population, bør en lavere startdosis overvejes, såfremt kliniske faktorer taler for dette (se pkt.
Owing to the greater sensitivity of this population, a lower starting dose should be considered when clinical factors warrant (see section 4.4).
Grækenland eller
Greece or
Der mangler langtidsdata, hvad angår aripiprazols virkning og sikkerhed til behandling af denne udsvingsprægede lidelse.
No long term data are available with regard to the efficacy and the safety of aripiprazole in this fluctuating disorder.
Efter enkelt oral dosis af 14C-mærket aripiprazol, blev ca. 27 % af den administrerede radioaktivitet genfundet i urinen og cirka 60 % i fæces.
Following a single oral dose of [14C]-labelled aripiprazole, approximately 27% of the administered radioactivity was recovered in the urine and approximately 60 % in the faeces.
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.
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.
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. den er i det væsentlige natrium-fri.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Dosis i disse forsøg var initialt 2 mg/dag, forhøjet til 5 mg/dag efter en uge og øget ugentligt med 5 mg/dag, indtil måldosis var nået.
Dosing in these trials was initiated at 2 mg/day, increased to 5 mg/day after one week, and increased by 5 mg/day in weekly increments to the target dose.
Hyperglykæmi og diabetes mellitus
Hyperglycaemia and diabetes mellitus
Aripiprazol viser antagonistiske egenskaber i dyremodeller med dopaminerg hyperaktivitet og agonistiske egenskaber i dyremodeller med dopaminerg hypoaktivitet.
Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic hypoactivity.
Ludomani og andre forstyrrelser af impulskontrollen
Pathological gambling and other impulse control disorders
Koncentrationerne af sulfatkonjugat af hydroxy/aripiprazol 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.
Aripiprazole Mylan Pharma er indiceret til behandling af skizofreni hos voksne og unge i alderen15 år og opefter.
Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Patienterne var 7-17 år og havde en gennemsnitlig baseline-score for samlede tics (Total Tic Score) på 30 på Yale Global Tic Severity-skalaen (TTS-YGTSS).
Patients were 7 - 17 years of age and presented an average score of 30 on Total Tic Score on the Yale Global Tic Severity Scale (TTS-YGTSS) at baseline.
Patienterne var 6-18 år og havde en gennemsnitlig baseline-score på 29 på TTS-YGTSSskalaen.
Patients were 6 - 18 years and presented an average score of 29 on TTS-YGTSS at baseline.
På baggrund af den metaboliske vej for aripiprazol, er dosisjustering for rygere ikke påkrævet (se pkt.
According to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers (see section 4.5).
Den maksimale daglige dosis på 30 mg bør imidlertid anvendes med forsigtighed hos patienter med stærkt nedsat leverfunktion (se pkt.
However, the maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
Ved antipsykotisk behandling kan der gå fra flere dage til nogle uger, før der ses bedring af patientens kliniske tilstand.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Følgende symptomer kan forekomme hos nyfødte af mødre, som har taget Aripiprazole Mylan Pharma i sidste trimester (de sidste tre måneder af graviditeten): rystelser, muskelstivhed og/eller svaghed, døsighed, ophidselse, vejrtrækningsbesvær og besvær med at indtage føde.
The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole Mylan Pharma tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Det er vigtigt, at du fortsætter med at tage Aripiprazole Mylan Pharma i så lang tid, som lægen har sagt, at du skal have det.
It is important that you carry on taking Aripiprazole Mylan Pharma for as long as your doctor has told you to.
Præcise risikovurderinger for hyperglykæmirelaterede bivirkninger hos patienter behandlet med aripiprazol eller andre atypiske antipsykotika er ikke tilgængelige til at kunne lave en direkte sammenligning.
Precise risk estimates for hyperglycaemia-related adverse reactions in patients treated with aripiprazole and with other atypical antipsychotics are not available to allow direct comparisons.
Aripiprazol er effektivt i et dosisinterval på 10 til 30 mg/dag.
Aripiprazole is effective in a dose range of 10 to 30 mg/day.
Efter 1326 ugers stabilisering med aripiprazol (2-15 mg/dag) fik patienter med stabil respons enten vedligeholdelse med aripiprazol eller blev skiftet over til placebo i yderligere 16 uger.
After a 13-26 week stabilisation on aripiprazole (2-15 mg/day) patients with a stable response were either maintained on aripiprazole or substituted to placebo for further 16 weeks.
Hvis du har taget for meget Aripiprazole Mylan Pharma Hvis du tror du har taget mere Aripiprazole Mylan Pharma end lægen har anbefalet (eller hvis en anden er kommet til at tage noget af din Aripiprazole Mylan Pharma), skal du straks kontakte lægen.
If you take more Aripiprazole Mylan Pharma than you should If you realise you have taken more Aripiprazole Mylan Pharma than your doctor has recommended (or if someone else has taken some of your Aripiprazole Mylan Pharma), contact your doctor right away.
Venøs tromboemboli (inklusive lungeemboli og dyb venetrombose) Hypertension Synkope
Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Hypertension
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.
I dette forsøg blev patienterne af investigatorerne tildelt enten ikke-blindet lithium eller valproat monoterapi for at bestemme delvist manglende respons.
In this trial, patients were assigned by investigators with either open-label lithium or valproate monotherapy to determine partial non-response.
I et kontrolleret forsøg med haloperidol var andelen af responderende patienter, der opretholdt respons på lægemidlet efter 52 uger, den samme i begge grupper (aripiprazol 77 % og haloperidol 73 %).
In a haloperidol-controlled trial, the proportion of responder patients maintaining response to medicinal product at 52-weeks was similar in both groups (aripiprazole 77 % and haloperidol 73 %).
Skizofreni hos unge
Schizophrenia in adolescents
Irritabilitet associeret med autisme: Aripiprazols sikkerhed og virkning hos børn og unge under 18 år er endnu ikke blevet klarlagt.
Irritability associated with autistic disorder: the safety and efficacy of aripiprazole in children and adolescents aged below 18 years have not yet been established.
Den gennemsnitlige vægtstigning i det 30-ugers behandlingsforløb var 2,9 kg sammenlignet med 0,98 kg for patienter behandlet med placebo.
Mean weight gain in the 30 weeks treatment-interval was 2.9 kg as compared to 0.98 kg in patients treated with placebo.
Der er hos voksne patienter i kliniske forsøg og efter markedsføring konstateret utilsigtet eller tilsigtet overdosering med aripiprazol alene i estimerede doser på op til 1260 mg uden dødsfald.
In clinical trials and post-marketing experience, accidental or intentional acute overdose of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg with no fatalities.
Kontakt straks lægen, hvis du lider af muskelstivhed eller manglende bøjelighed med feber, sveden, ændret mental tilstand eller meget hurtig eller uregelmæssig hjerterytme.
Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat.
Et enkeltdosis-forsøg med patienter med varierende grad af levercirrhose (Child-Pugh-klasse A, B og C) har ikke vist, at hepatisk svækkelse skulle have signifikant betydning for farmakokinetik for aripiprazol og dehydro-aripiprazol, men undersøgelsen omfattede kun 3 patienter med klasse C levercirrhose, hvilket er utilstrækkelig basis for en konklusion vedrørende metabolisk kapacitet.
A single-dose study in subjects with varying degrees of liver cirrhosis (Child-Pugh Classes A, B, and C) did not reveal a significant effect of hepatic impairment on the pharmacokinetics of aripiprazole and dehydro-aripiprazole, but the study included only 3 patients with Class C liver cirrhosis, which is insufficient to draw conclusions on their metabolic capacity.
I kliniske forsøg havde en daglig dosis på 10-30 mg aripiprazol ingen signifikant effekt på metabolismen af CYP2D6-substrater (dextromethorphan/3-methoxymorphinan forholdet), CYP2C9 (warfarin), CYP2C19 (omeprazol) og CYP3A4 (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), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP3A4 (dextromethorphan).
Farmakokinetikken af aripiprazol og dehydroaripiprazol hos pædiatriske patienter i alderen 10-17 år, svarede til den hos voksne, efter der er taget højde for forskellen i kropsvægt.
The pharmacokinetics of aripiprazole and dehydro-aripiprazole in paediatric patients 10 to 17 years of age were similar to those in adults after correcting for the differences in body weights.
Yngre patienter har en øget risiko for at opleve bivirkninger i forbindelse med aripiprazol.
Younger patients are at increased risk of experiencing adverse events associated with aripiprazole.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERKORT
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Punktestimatet for hazard ratioen i hele populationen var 0,461 (95 %-konfidensinterval, 0,2420,879).
The point estimate of the hazard ratio (HR) was 0.461 (95% confidence interval, 0.242-0.879) in the full population.
Inden for hver hyppighedgruppe er bivirkningerne opført efter, hvor alvorlige de er.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
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 reactions (including diabetes) or in abnormal glycaemia laboratory values compared to placebo.
Behandling bør påbegyndes med 2 mg (ved at anvende et passende lægemiddel indeholdende aripiprazol) i 2 dage, der optitreres til 5 mg i yderligere 2 dage, indtil den anbefalede daglige dosis på 10 mg er nået.
Treatment should be initiated at 2 mg (using an appropriate aripiprazole containing medicinal product) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg.
Andre ekstrapyramidale symptomer
Other extrapyramidal symptoms
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 %, respectively.