FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Hvis patienten udvikler symptomer på NMS, eller uforklarligt får høj feber uden andre kliniske manifestationer på NMS, skal alle antipsykotika, inklusive aripiprazol, seponeres.
English: Four mood stabilizer subgroups were assessed in the randomised phase: aripiprazole + lithium; aripiprazole + valproate; placebo + lithium; placebo + valproate.
Danish: Fire subgrupper blev undersøgt i den randomiserede fase: aripiprazol + lithium, aripiprazol + valproat; placebo + lithium; placebo + valproat.
English: Tardive dyskinesia
Danish: Tardiv dyskinesi
English: Aripiprazole Mylan Pharma contains the active substance aripiprazole and belong to a group of medicines called antipsychotics.
Danish: Aripiprazole Mylan Pharma indeholder det aktive stof aripiprazol, som tilhører en gruppe af lægemidler, der kaldes antipsykotika.
English: Class effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment.
Danish: Klasseeffekt - der kan forekomme symptomer på dystoni, længerevarende anormale sammentrækninger af muskelgrupper hos modtagelige individer i de første par dage af behandlingen.
English: 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.
Danish: 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.
English: In the paediatric population somnolence and fatigue were observed more frequently in patients with bipolar disorder compared to patients with schizophrenia.
Danish: I den pædiatriske population blev der hyppigere observeret døsighed og træthed hos patienter med bipolær lidelse end hos patienter med skizofreni.
English: 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.
Danish: 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.
English: Aripiprazole is not indicated for the treatment of patients with dementia-related psychosis.
Danish: Aripiprazol er ikke indiceret til behandling af patienter med demensrelateret psykose.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia.
Danish: Aripiprazol bør anvendes med forsigtighed hos patienter med risiko for aspirationspneumoni.
English: Aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/kg, indicating extensive extravascular distribution.
Danish: Aripiprazol fordeles i stor udstrækning, med et faktisk fordelingsvolumen på 4,9 l/kg, indikerende omfattende ekstravaskulær fordeling.
English: Patients were stabilised for at least 12 consecutive weeks with the combination of aripiprazole and the same mood stabilizer.
Danish: Patienterne blev stabiliseret i mindst 12 konsekutive uger med kombinationsbehandling med aripiprazol og den samme stemningsstabilisator.
English: Owing to the greater sensitivity of this population, a lower starting dose should be considered when clinical factors warrant (see section 4.4).
Danish: På grund af den øgede følsomhed hos denne population, bør en lavere startdosis overvejes, såfremt kliniske faktorer taler for dette (se pkt.
English: Greece or
Danish: Grækenland eller
English: No long term data are available with regard to the efficacy and the safety of aripiprazole in this fluctuating disorder.
Danish: Der mangler langtidsdata, hvad angår aripiprazols virkning og sikkerhed til behandling af denne udsvingsprægede lidelse.
English: 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.
Danish: Efter enkelt oral dosis af 14C-mærket aripiprazol, blev ca. 27 % af den administrerede radioaktivitet genfundet i urinen og cirka 60 % i fæces.
English: 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.
Danish: 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.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. den er i det væsentlige natrium-fri.
English: 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.
Danish: 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.
English: Hyperglycaemia and diabetes mellitus
Danish: Hyperglykæmi og diabetes mellitus
English: Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties in animal models of dopaminergic hypoactivity.
Danish: Aripiprazol viser antagonistiske egenskaber i dyremodeller med dopaminerg hyperaktivitet og agonistiske egenskaber i dyremodeller med dopaminerg hypoaktivitet.
English: Pathological gambling and other impulse control disorders
Danish: Ludomani og andre forstyrrelser af impulskontrollen
English: 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.
Danish: 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.
English: Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Danish: Aripiprazole Mylan Pharma er indiceret til behandling af skizofreni hos voksne og unge i alderen15 år og opefter.
English: 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.
Danish: 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).
English: Patients were 6 - 18 years and presented an average score of 29 on TTS-YGTSS at baseline.
Danish: Patienterne var 6-18 år og havde en gennemsnitlig baseline-score på 29 på TTS-YGTSSskalaen.
English: According to the metabolic pathway of aripiprazole no dosage adjustment is required for smokers (see section 4.5).
Danish: På baggrund af den metaboliske vej for aripiprazol, er dosisjustering for rygere ikke påkrævet (se pkt.
English: However, the maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment (see section 5.2).
Danish: Den maksimale daglige dosis på 30 mg bør imidlertid anvendes med forsigtighed hos patienter med stærkt nedsat leverfunktion (se pkt.
English: During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Danish: Ved antipsykotisk behandling kan der gå fra flere dage til nogle uger, før der ses bedring af patientens kliniske tilstand.
English: 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.
Danish: 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.
English: It is important that you carry on taking Aripiprazole Mylan Pharma for as long as your doctor has told you to.
Danish: 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.
English: 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.
Danish: Præcise risikovurderinger for hyperglykæmirelaterede bivirkninger hos patienter behandlet med aripiprazol eller andre atypiske antipsykotika er ikke tilgængelige til at kunne lave en direkte sammenligning.
English: Aripiprazole is effective in a dose range of 10 to 30 mg/day.
Danish: Aripiprazol er effektivt i et dosisinterval på 10 til 30 mg/dag.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Hypertension
Danish: Venøs tromboemboli (inklusive lungeemboli og dyb venetrombose) Hypertension Synkope
English: A gastric acid blocker, the H2 antagonist famotidine, reduces aripiprazole rate of absorption but this effect is deemed not clinically relevant.
Danish: Syreblokkeren og H2-antagonisten famotidin nedsætter absorptionshastigheden for aripiprazol, men denne virkning synes ikke klinisk relevant.
English: In this trial, patients were assigned by investigators with either open-label lithium or valproate monotherapy to determine partial non-response.
Danish: I dette forsøg blev patienterne af investigatorerne tildelt enten ikke-blindet lithium eller valproat monoterapi for at bestemme delvist manglende respons.
English: 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 %).
Danish: 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 %).
English: Schizophrenia in adolescents
Danish: Skizofreni hos unge
English: Irritability associated with autistic disorder: the safety and efficacy of aripiprazole in children and adolescents aged below 18 years have not yet been established.
Danish: Irritabilitet associeret med autisme: Aripiprazols sikkerhed og virkning hos børn og unge under 18 år er endnu ikke blevet klarlagt.
English: Mean weight gain in the 30 weeks treatment-interval was 2.9 kg as compared to 0.98 kg in patients treated with placebo.
Danish: Den gennemsnitlige vægtstigning i det 30-ugers behandlingsforløb var 2,9 kg sammenlignet med 0,98 kg for patienter behandlet med placebo.
English: 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.
Danish: 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.
English: 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.
Danish: Kontakt straks lægen, hvis du lider af muskelstivhed eller manglende bøjelighed med feber, sveden, ændret mental tilstand eller meget hurtig eller uregelmæssig hjerterytme.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: Younger patients are at increased risk of experiencing adverse events associated with aripiprazole.
Danish: Yngre patienter har en øget risiko for at opleve bivirkninger i forbindelse med aripiprazol.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERKORT
English: The point estimate of the hazard ratio (HR) was 0.461 (95% confidence interval, 0.242-0.879) in the full population.
Danish: Punktestimatet for hazard ratioen i hele populationen var 0,461 (95 %-konfidensinterval, 0,2420,879).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedgruppe er bivirkningerne opført efter, hvor alvorlige de er.
English: 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.
Danish: I kliniske undersøgelser med aripiprazol sås ingen signifikant forskel i forekomst af hyperglykæmirelaterede bivirkninger (herunder diabetes) eller i abnorme glykæmiske laboratorieværdier sammenlignet med placebo.
English: 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.
Danish: 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.
English: Other extrapyramidal symptoms
Danish: Andre ekstrapyramidale symptomer
English: The AUC and Cmax of dehydro-aripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively.
Danish: AUC og Cmax for dehydro-aripiprazol, den aktive metabolit, reduceredes med henholdsvis 32 % og 47 %.
English: • high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes
Danish: højt blodsukker (karakteriseret ved symptomer såsom voldsom tørst, udskillelse af store mængder urin, øget appetit og svaghedsfølelse) eller arvelig sukkersyge (diabetes)
English: Increased Alanine Aminotransferase (ALT) Increased Aspartate Aminotransferase (AST) Increased Gamma Glutamyl Transferase (GGT) Increased alkaline phosphatase
Danish: Forhøjet alaninaminotransferase (ALAT) Forhøjet aspartat aminotransferase (ASAT)Forhøjet gammaglutamyltransferase (GGT)
English: When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary adenoma.
Danish: Når det ses, er det sædvanligvis hos patienter med signifikante risikofaktorer som fx anamnestisk diabetes, thyreoideasygdomme eller hypofyseadenom.
English: However, the estimation of the HR for the younger (13-14 years) group was not precise, reflecting the smaller number of subjects in that group (aripiprazole, n = 29; placebo, n = 12), and the confidence interval for this estimation (ranging from 0.151 to 1.628) did not allow conclusions to be drawn on the presence of a treatment effect.
Danish: Estimatet for hazard ratio hos den yngste gruppe (13-14 år) var imidlertid ikke præcist, idet der var et lavere antal patienter i den gruppe (aripiprazol, n = 29; placebo, n = 12), og konfidensintervallet for dette estimat (0,151-1,628) gjorde det ikke muligt at drage en konklusion med hensyn til eventuel behandlingseffekt.
English: LIST OF EXCIPIENTS Contains maltose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder maltose.
English: When appropriate, subsequent dose increases should be administered in 5 mg increments without exceeding the maximum daily dose of 30 mg (see section 5.1).
Danish: Om nødvendigt skal en efterfølgende øgning af dosis ske trinvist med 5 mg uden at overskride den maksimale daglige dosis på 30 mg (se pkt.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with aripiprazole in one or more subsets of the paediatric population in the treatment of schizophrenia and in the treatment of bipolar affective disorder (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med aripiprazol i en eller flere undergrupper af den pædiatriske population ved behandling af skizofreni og bipolær lidelse (se pkt.
English: If you stop taking Aripiprazole Mylan Pharma Do not stop your treatment just because you feel better.
Danish: Hvis du holder op med at tage Aripiprazole Mylan Pharma Du må ikke stoppe med at tage lægemidlet, fordi du har fået det bedre.
English: It is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole.
Danish: Det er vigtigt for ordinerende læger at spørge patienterne eller deres plejepersoner specifikt om udvikling af nye former for trang eller øget trang til hasardspil, sex, indkøb, overspisning eller andre former for trang under behandling med aripiprazol.
English: Tics associated with Tourette's disorder: the safety and efficacy of aripiprazole in children and adolescents 6 to 18 years of age have not yet been established.
Danish: Tics associeret med Tourettes syndrom: Aripiprazols sikkerhed og virkning hos børn og unge i alderen 6-18 år er endnu ikke klarlagt.
English: Tardive dyskinesia Dystonia
Danish: Tardiv dyskinesi Dystoni
English: Orodispersible tablets or oral solution may be used as an alternative to Aripiprazole Mylan Pharma tablets for patients who have difficulty swallowing Aripiprazole Mylan Pharma tablets (see section 5.2).
Danish: Smeltetabletterne eller den orale opløsning kan anvendes som et alternativ til Aripiprazole Mylan Pharma-tabletter til patienter, som har svært ved at sluge Aripiprazole Mylan Pharma-tabletter (se også pkt.
English: If you are taking, Aripiprazole Mylan Pharma your doctor will discuss with you whether you should breast-feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding.
Danish: Hvis du tager Aripiprazole Mylan Pharma, vil din læge drøfte med dig, om du bør amme dit barn, ved at se på fordelen for dig ved behandling og fordelen ved amning for barnet.
English: Suicide attempt, suicidal ideation and completed suicide (see section 4.4)
Danish: Selvmordsforsøg, selvmordsforestillinger og gennemførte selvmord (se pkt.
English: • The active substance is aripiprazole.
Danish: Det aktive stof er aripiprazol.
English: Other urges, reported, include: increased sexual urges, compulsive shopping, binge or compulsive eating, and other impulsive and compulsive behaviours.
Danish: Andre former for trang, der er blevet rapporteret, omfatter: øget seksualdrift, kompulsiv trang til indkøb, overspisning samt anden impulsiv og kompulsiv adfærd.
English: Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The mean weight gain over the stabilisation phase (up to 26 weeks) on aripiprazole was 3.2 kg, and a further mean increase of 2.2 kg for aripiprazole as compared to 0.6 kg for placebo was observed in the second phase (16 weeks) of the trial.
Danish: Den gennemsnitlige vægtstigning i stabiliseringsfasen (op til 26 uger) med aripiprazol var 3,2 kg, og en yderligere gennemsnitlig vægtstigning på 2,2 kg for aripiprazol, sammenlignet med 0,6 kg for placebo, blev observeret i den anden fase (16 uger) af studiet.
English: Kaplan-Meier relapse rates at week 16 were 35% for aripiprazole and 52% for placebo; the hazard ratio for relapse within 16 weeks (aripiprazole/placebo) was 0.57 (non-statistically significant difference).
Danish: Kaplan-Meier recidivraten ved uge 16 var 35 % for aripiprazol og 52 % for placebo; hazard ratio for recidiv inden for 16 uger (aripiprazol/placebo) var 0,57 (ikke statistisk signifikant forskel).