FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not known if it is safe and effective in these patients.
Danish: Dets sikkerhed og virkning hos denne patientgruppe kendes ikke.
English: Patients were 6 to 18 years and presented an average score of 29 on TTS-YGTSS at baseline.
Danish: Patienterne var 6 til 18 år og havde en gennemsnitlig baseline-score på 29 på TTS-YGTSSskalaen.
English: The observed mean improvement from baseline on the PANSS Excitement Component score at the primary 2-hour endpoint was 5.8 for placebo, 9.6 for lorazepam, and 8.7 for ABILIFY solution for injection.
Danish: Den observerede gennemsnitlige forbedring fra baseline i affektkomponent-scoren i PANSS ved det primære 2-timers endepunkt var 5,8 for placebo, 9,6 for lorazepam og 8,7 for ABILIFY injektionsvæske, opløsning.
English: The information below is obtained from studies with oral aripiprazole.
Danish: Oplysningerne nedenfor stammer fra studier med oralt aripiprazol.
English: Schizophrenia with oral aripiprazole
Danish: Skizofreni med oral aripiprazol
English: Hyponatremia Anorexia
Danish: Hyponatriæmi Anoreksi
English: Extrapyramidal symptoms were mainly reported during the stabilisation phase in 17 % of patients, with tremor accounting for 6.5 %.
Danish: Ekstrapyramidale symptomer blev rapporteret hos 17 % af patienterne, hovedsageligt i stabiliseringsfasen; heraf udgjorde tremor 6,5 %.
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 til 17 år, svarede til den hos voksne, efter der er taget højde for forskellen i kropsvægt.
English: Treatment with ABILIFY solution for injection should be discontinued as soon as clinically appropriate and the use of oral aripiprazole should be initiated.
Danish: Behandling med ABILIFY injektionsvæske, opløsning skal seponeres så hurtigt som klinisk muligt, og brug af oral aripiprazol påbegyndes.
English: • uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
Danish: • ukontrollerede bevægelser af mund, tunge og arme og ben (tardiv dyskinesi),
English: ABILIFY is 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: ABILIFY 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 hurtigt tale med et væld af idéer og nogle gange voldsom irritabilitet.
English: • Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include: strong impulse to gamble excessively despite serious personal or family consequences altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive uncontrollable excessive shopping binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) a tendency to wander away.
Danish: • manglende evne til at modstå trangen eller fristelsen til at udføre en handling, der kan være skadelig for dig selv eller andre, og som kan omfatte: - stærk trang til at spille (sygelig spilletrang) trods alvorlige personlige og familiemæssige konsekvenser, - ændret eller øget seksuel interesse og adfærd, der vækker stor bekymring hos dig eller andre, for eksempel en øget seksualdrift, - ukontrollerbart overdrevent indkøbsmønster og forbrug, - uhæmmet madindtagelse (spise store mængder mad i en kort periode) eller overdreven madindtagelse (spise mere mad end sædvanligt og mere end nødvendigt for at dække sulten), - tilbøjelighed til at vandre omkring.
English: Neuroleptic Malignant Syndrome Grand mal convulsion Serotonin syndrome Speech disorder
Danish: Malignt neuroleptikasyndrom Grand mal-kramper Serotoninsyndrom Taleforstyrrelser
English: Patients who have been given too much aripiprazole have experienced the following symptoms:
Danish: Patienter, der har fået for meget aripiprazol, har oplevet følgende symptomer:
English: Sudden death unexplained Torsades de pointes Ventricular arrhythmia Cardiac arrest Bradycardia
Danish: Pludselig uforklarlig død Torsades de pointes Ventrikulære arytmier Hjertestop
English: • high blood pressure,
Danish: • højt blodtryk,
English: • rapid heartbeat, agitation/aggressiveness, problems with speech.
Danish: • Hjertebanken, uro/aggressivitet, talebesvær.
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).
English: Following any confirmed or suspected accidental overdose/inadvertent intravenous administration, close observation of the patient is needed and if any potentially medically serious sign or symptom develops, monitoring, which should include continuous electrocardiographic monitoring, is required.
Danish: Efter en bekræftet eller formodet utilsigtet overdosering/utilsigtet intravenøs administration er det nødvendigt at holde patienten under tæt observation, og hvis der opstår et medicinsk alvorligt tegn eller symptom, er nøje overvågning af patienten påkrævet, herunder kontinuerlig overvågning med ekg.
English: This medicinal product may be started at a low dose with the oral solution (liquid) form.
Danish: Der kan startes med en lav dosis af dette lægemiddel som oral opløsning.
English: It can be taken with or without liquid.
Danish: Smeltetabletten kan tages med eller uden væske.
English: • shaking and blurred vision,
Danish: • rysten og sløret syn,
English: In the placebocontrolled 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 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: The dose of ABILIFY must be measured using the calibrated cup or the 2 mL calibrated dropping pipette supplied in the carton.
Danish: Dosis af ABILIFY skal måles ved hjælp af det kalibrerede målebæger eller 2 ml pipetten, som findes i pakningen.
English: Outer carton: abilify 1 mg/mL
Danish: Ydre karton: abilify 1 mg/ml
English: In 2 studies in healthy subjects the median times to the peak plasma concentrations were 1 and 3 hours after dosing.
Danish: I 2 forsøg med raske frivillige var median-tid til maksimal plasmakoncentration 1 og 3 timer efter administration.
English: Oral solution Clear, colourless to light yellow liquid solution.
Danish: Oral opløsning Klar, farveløs til lysegul væske.
English: If you see more than one doctor, be sure to tell them that you are receiving ABILIFY.
Danish: Hvis du tilses af mere end én læge, skal du sige til de pågældende læger, at du får ABILIFY.
English: Aripiprazole is well absorbed when administered orally as the solution.
Danish: Aripiprazol absorberes godt, når det administreres peroralt som opløsning.
English: In three placebo-controlled trials (n = 938; mean age: 82.4 years; range: 56 to 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 til 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: Irritability associated with autistic disorder: the safety and efficacy of ABILIFY in children and adolescents aged below 18 years have not yet been established.
Danish: Irritabilitet associeret med autisme: ABILIFYs sikkerhed og virkning hos børn og unge under 18 år er endnu ikke blevet klarlagt.
English: • allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
Danish: • allergiske reaktioner (fx hævelse i mund, tunge, ansigt og hals, kløe og udslæt),
English: • low levels of white blood cells,
Danish: • lav mængde hvide blodlegemer,
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,
English: Adjunctive aripiprazole demonstrated superiority over placebo on the secondary outcome measure in Clinical Global Impression - Bipolar version (CGI-BP) Severity of Illness (SOI; mania) scores.
Danish: Aripiprazol som tillægsbehandling viste superioritet i forhold til placebo for det sekundære endepunkt i Clinical Global Impression - Bipolar version (CGI-BP) Severity of Illness-score (mani).
English: ABILIFY 1 mg/mL oral solution is a clear, colourless to light yellow liquid supplied in bottles with polypropylene child-resistant closure containing 50 mL, 150 mL or 480 mL per bottle.
Danish: ABILIFY 1 mg/ml oral opløsning er en klar, farveløs til lysegul væske i polyethylenflaske med børnesikret polypropylenlåg, der indeholder 50 ml, 150 ml eller 480 ml pr. flaske.
English: At equivalent doses, the peak plasma concentrations of aripiprazole (Cmax) from the solution were somewhat higher but the systemic exposure (AUC) was equivalent to tablets.
Danish: Ved ækvivalente doser var maksimal plasmakoncentrationen af aripiprazol (Cmax) for opløsningen noget højere end for tabletterne, men den systemiske optagelse (AUC) var ækvivalent.
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: • abnormal muscle breakdown which can lead to kidney problems,
Danish: • unormal muskelnedbrydning, hvilket kan medføre nyreproblemer,
English: Somnolence/sedation and extrapyramidal disorder were reported very commonly (≥ 1/10), and dry mouth, increased appetite, and orthostatic hypotension were reported commonly (≥ 1/100, < 1/10).
Danish: Døsighed/sedation og ekstrapyramidale forstyrrelser blev meget almindeligt rapporteret (≥ 1/10) og tør mund, øget appetit og ortostatisk hypotension blev almindeligt rapporteret (≥ 1/100 til < 1/10).
English: The oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Danish: Den orale opløsning indeholder methylparahydroxybenzoat samt propylparahydroxybenzoat.
English: ABILIFY solution for injection should not be administered intravenously or subcutaneously.
Danish: ABILIFY injektionsvæske, opløsning må ikke administreres intravenøst eller subkutant.
English: Talk to your doctor about the best way to feed your baby if you are receiving this medicine.
Danish: Tal med lægen om, hvordan du bedst kan ernære dit barn, hvis du får dette lægemiddel.
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 delgruppe-analyserne var punktestimatet for hazard ratioen 0,495 hos patienter i alderen 13 til 14 år og 0,454 hos patienter i alderen 15 til 17 år.
English: Schizophrenia: in a long-term 52-week controlled trial, aripiprazole-treated patients had an overalllower incidence (25.8 %) of EPS including Parkinsonism, akathisia, dystonia and dyskinesia compared with those treated with haloperidol (57.3 %).
Danish: 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 (57,3 %).
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 QT-forlængelse (se pkt.
English: The recommended dose is 9.75 mg (1.3 mL) for the first injection.
Danish: Den anbefalede dosis er 9,75 mg (1,3 ml) ved første injektion.
English: Diastolic blood pressure increased
Danish: Øget diastolisk blodtryk
English: This medicine will be given to you under medical supervision; it is therefore unlikely that you will be given too much.
Danish: Det er ikke sandsynligt, at du får for meget af dette lægemiddel, da det gives til dig under lægeligt tilsyn.
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 YMRS-score.
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, High Density Lipoprotein (HDL) and Low Density Lipoprotein (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 (højdensitetslipoprotein) og LDL (lavdensitetslipoprotein).
English: Contents of the pack and other information What ABILIFY contains
Danish: Pakningsstørrelser og yderligere oplysninger ABILIFY indeholder
English: Treatment should be initiated at 2 mg (using ABILIFY oral solution 1 mg/mL) 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 ABILIFY oral opløsning 1 mg/ml) i 2 dage, der optitreres til 5 mg i yderligere 2 dage, indtil den anbefalede daglige dosis på 10 mg er nået.
English: It may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Danish: Det kan være skadeligt for patienter med phenylketonuri (PKU, Føllings sygdom), en sjælden genetisk lidelse, hvor phenylalanin ophobes, fordi kroppen ikke kan fjerne det ordentligt.
English: ABILIFY 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: ABILIFY bør ikke anvendes til børn under 15 år med skizofreni på grund af utilstrækkelig dokumentation for sikkerhed og virkning (se pkt.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, carcinogent potentiale samt reproduktions- og udviklingstoksicitet.
English: The orodispersible tablet can be taken with or without liquid.
Danish: Tabletten kan tages med eller uden væske.
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 aripiprazol, skal dosisreduktion og tæt klinisk monitorering overvejes.
English: Each carton contains 1 bottle and both a calibrated polypropylene measuring cup with a graduation interval of 2.5 mL and a calibrated polypropylene low-density polyethylene dropping pipette with a graduation interval of 0.5 mL.
Danish: Hver pakning indeholder en flaske og både et kalibreret polypropylen-målebæger med et gradueringsinterval på 2,5 ml og en kalibreret polypropylen low-density polyethylen pipette med et gradueringsinterval på 0,5 ml.
English: No specific interaction studies have been performed with ABILIFY solution for injection.
Danish: Der er ikke udført specifikke interaktionsstudier med ABILIFY injektionsvæske, opløsning.
English: Diabetes mellitus Hyperglycaemia
Danish: Diabetes mellitus Hyperglykæmi
English: Aripiprazole doses ranging from 0.5 mg 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 mg til 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: The European Medicines Agency has deferred the obligation to submit the results of studies with ABILIFY 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 ABILIFY i en eller flere undergrupper af den pædiatriske population ved behandling af skizofreni og bipolær lidelse (se pkt.
English: • diabetes mellitus,
Danish: • diabetes mellitus (sukkersyge),
English: • combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
Danish: • kombination af feber, muskelstivhed, hurtigere vejrtrækning, svedtendens, nedsat bevidsthed og pludselige ændringer i blodtryk og hjerterytme, besvimelse (malignt neuroleptisk syndrom),
English: Patients receiving ABILIFY solution for injection should be observed for orthostatic hypotension.
Danish: Patienter der behandles med ABILIFY injektionsvæske, opløsning skal observeres for ortostatisk hypotension.
English: Each carton contains one bottle and both a calibrated polypropylene measuring cup and a calibrated polypropylene low-density polyethylene dropping pipette.
Danish: Hver pakning indeholder en flaske og både et kalibreret målebæger af polypropylen og en kalibreret polypropylen low-density polyethylen pipette.
English: Tics associated with Tourette's disorder: the safety and efficacy of ABILIFY in children and adolescents 6 to 18 years of age have not yet been established.
Danish: Tics associeret med Tourettes syndrom: ABILIFYs sikkerhed og virkning hos børn og unge i alderen 6 til 18 år er endnu ikke klarlagt.
English: Patients treated with any antipsychotics, 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: The effective dose range of ABILIFY solution for injection is 5.25 mg to 15 mg as a single injection.
Danish: Effektivt dosisområde for ABILIFY injektionsvæske, opløsning er 5,25 mg til 15 mg som enkeltinjektion.
English: PET-bottles with polypropylene child-resistant closure containing 50 mL, 150 mL or 480 mL per bottle.
Danish: Polyethylenflaske med børnesikret polypropylenlåg indeholdende 50 ml, 150 ml eller 480 ml pr. flaske.
English: • spasm of the muscles around the voice box,
Danish: • muskelkramper omkring strubehovedet,
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis) Hypertension
Danish: Venøs tromboemboli (inklusive lungeemboli og dyb venetrombose) Hypertension
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 middel-steady-state AUC ved maksimal, anbefalet klinisk dosis.
English: However, the estimation of the HR for the younger (13 to 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 til 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 til 1,628) gjorde det ikke muligt at drage en konklusion med hensyn til eventuel behandlingseffekt.
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 til 0,879, og derfor kunne der konstateres en behandlingseffekt blandt de ældste patienter.
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 kraftig nedsat leverfunktion (se pkt.
English: • low levels of blood platelets,
Danish: • lav mængde blodplader,
English: However, in one of these trials, a fixed-dose trial, there was a significant dose response relationship for cerebrovascular adverse reactions in patients treated with aripiprazole (see section 4.8).
Danish: I et af disse forsøg, et forsøg med fast dosis, sås signifikant dosis-responsforhold for cerebrovaskulære bivirkninger hos aripiprazol-behandlede patienter (se pkt.
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-YGTSSforbedring 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: Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain
Danish: Forstyrrelser i temperaturreguleringen (fx hypotermi, pyreksi) Brystsmerter