FrancophonIA/ELRC3.0 huggingface dataset:
English: • unusual movements (especially of the face or tongue) and reduced level of consciousness.
Danish: • Usædvanlige bevægelser (især i ansigtet og med tungen) og nedsat bevidsthedsniveau.
English: • involuntary, irregular muscle movements, especially in the face
Danish: • ufrivillige, uregelmæssige muskelsammentrækninger, specielt i ansigtet
English: ABILIFY with food, drink and alcohol
Danish: Brug af ABILIFY sammen med mad, drikke og alkohol
English: Blood pressure, pulse, respiratory rate and level of consciousness should be monitored regularly.
Danish: Blodtryk, puls, respirationsfrekvens og bevidsthedsniveau skal monitoreres jævnligt.
English: A second injection may be administered 2 hours after the first injection, on the basis of individual clinical status and no more than three injections should be given in any 24-hour period.
Danish: Yderligere injektion kan administreres 2 timer efter første injektion, på baggrund af individuel klinisk status; der bør ikke gives mere end 3 injektioner i løbet af en 24-timers periode.
English: • thoughts of suicide, suicide attempt and suicide,
Danish: • selvmordstanker, selvmordsforsøg og selvmord,
English: The doctor may also want to measure your blood pressure and pulse.
Danish: Lægen kan vælge at måle dit blodtryk og puls.
English: OUTER CARTON AND BOTTLE LABEL
Danish: YDRE KARTON OG FLASKENS ETIKET
English: • altered or increased sexual interest,
Danish: • ændret eller øget interesse for sex,
English: • fixation of the eyeballs in one position,
Danish: • fiksering af øjenæblerne i en fast position,
English: EXP Use within 6 months after first opening.
Danish: EXP Bruges inden 6 måneder efter åbning.
English: • Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
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:
English: - strong impulse to gamble excessively despite serious personal or family consequences
Danish: - stærk trang til at spille (sygelig spilletrang) trods alvorlige personlige og familiemæssige konsekvenser,
English: Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.
Danish: Selvom du føler du har det bedre, må du ikke ændre eller lade være med at tage den daglige dosis af ABILIFY uden først at have kontaktet lægen.
English: • fits (seizures) since your doctor may want to monitor you more closely
Danish: • krampeanfald - i givet fald vil din læge overvåge dig tættere
English: If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Danish: Hvis du ikke kan få fat i lægen, skal du tage til den nærmeste skadestue og medbringe medicinpakningen.
English: Outer carton:
Danish: Ydre karton:
English: Blood pressure-lowering medicines: ABILIFY may increase the effect of medicines used to lower the blood pressure.
Danish: Blodtrykssænkende medicin: ABILIFY kan forstærke virkningen af medicin, der bruges til at sænke blodtrykket.
English: Use within 6 months after first opening.
Danish: Anvendes inden 6 måneder efter første åbning.
English: Fructose may damage teeth.
Danish: Fructose kan skade tænderne.
English: Your doctor will decide how much ABILIFY you need and how long you need it for.
Danish: Lægen beslutter, hvor meget ABILIFY du skal have, og hvor længe du skal have det.
English: If you realise you have taken more ABILIFY than your doctor has recommended (or if someone else has taken some of your ABILIFY), contact your doctor right away.
Danish: Hvis du tror, du har taget mere ABILIFY, end lægen har anbefalet (eller hvis en anden er kommet til at tage noget af din ABILIFY), skal du straks kontakte lægen.
English: Your doctor will change your treatment to oral ABILIFY as soon as appropriate.
Danish: Lægen ændrer behandlingen til oral ABILIFY, så snart det er hensigtsmæssigt.
English: Sucrose may be harmful to the teeth.
Danish: Saccharose kan være skadelig for tænderne.
English: • yellowing of the skin and white part of eyes,
Danish: • gulfarvning af huden og det hvide i øjnene,
English: Do not open the blister until ready to administer.
Danish: Åbn ikke blisteren før du er klar til at tage smeltetabletten.
English: Aripiprazole/metabolites are excreted in human milk.
Danish: Aripiprazol/metabolitter udskilles i human mælk.
English: Do not use this medicine in children and adolescents under 18 years of age.
Danish: Dette lægemiddel må ikke anvendes til børn og unge under 18 år.
English: • swelling of hands, ankles or feet,
Danish: • opsvulmede hænder, ankler eller fødder,
English: Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister.
Danish: Da smeltetabletten er skrøbelig, bør den indtages straks efter åbning af blisteret.
English: Contains fructose, sucrose, E218, and E216.
Danish: Indeholder fructose, saccharose, E218 og E216.
English: • if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for aripiprazol eller et af de øvrige indholdsstoffer (angivet i afsnit 6).
English: - altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
Danish: - ændret eller øget seksuel interesse og adfærd, der vækker stor bekymring hos dig eller andre, for eksempel en øget seksualdrift,
English: Therefore cardiovascular monitoring should be started immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
Danish: Kardiovaskulær overvågning bør derfor straks indledes og bør omfatte løbende elektrokardiografisk overvågning med henblik på eventuelle arytmier.
English: Actual scores in rating scales used as secondary endpoints, including PANSS and the Montgomery-Åsberg Depression Rating Scale (MADRS) showed a significant improvement over haloperidol.
Danish: Faktiske scorer på bedømmelsesskalaer anvendt som sekundære endepunkt, inklusive PANSS og Montgomery-Asberg Depression Rating Scale (MADRS), viste en signifikant forbedring i forhold til haloperidol.
English: Depression Hypersexuality
Danish: Depression Hyperseksualitet
English: Among the patients included in the primary efficacy analysis, 139 patients had a current co-morbid diagnosis of ADHD.
Danish: Blandt patienterne, inkluderet i den primære effektanalyse, var 139 patienter diagnosticeret med ADHD som co-morbiditet.
English: The safety profile in a 26-week open-label extension trial was similar to that observed in the shortterm, placebo-controlled trial.
Danish: Sikkerhedsprofilen i et 26-ugers åbent, forlænget forsøg var den samme som den, der blev observeret i det korte, placebokontrollerede forsøg.
English: This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
Danish: Der skal tages hensyn til dette i situationer, der kræver fuld opmærksomhed, f.eks. ved bilkørsel eller betjening af maskiner.
English: In adults it also prevents this condition from returning in patients who have responded to the treatment with ABILIFY.
Danish: Hos voksne forebygger det også, at tilstanden vender tilbage hos patienter, der har haft god effekt af behandling med ABILIFY.
English: Care must be taken to avoid inadvertent injection of this medicinal product into a blood vessel.
Danish: Man skal omhyggeligt sikre sig, at dette lægemiddel ikke injiceres i et blodkar.
English: ABILIFY is ready to use.
Danish: ABILIFY er klar til brug.
English: The total body clearance of aripiprazole is 0.7 mL/min/kg, which is primarily hepatic.
Danish: Total-clearance af aripiprazol er 0,7 ml/min/kg, primært hepatisk.
English: • withdrawal symptoms in newborn babies in case of exposure during pregnancy,
Danish: • abstinenssymptomer hos nyfødte ved indgivelse under graviditet,
English: • feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Danish: • en følelse af at være "høj", at have 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: This medicine can be given regardless of meals.
Danish: Dette lægemiddel kan gives uafhængigt af måltider.
English: In a sub-analysis of the adolescent patients between the ages of 15 to 17 years, representing 74 % of the total enrolled population, maintenance of effect was observed over the 26-week open-label extension trial.
Danish: I en delanalyse af de unge patienter mellem 15 og 17 år, som repræsenterede 74 % af den totale inkluderede population, blev effekten bibeholdt i det 26-uger åbne, forlængelsesforsøg.
English: Do not push the tablet through the foil because this could damage the tablet.
Danish: Tryk ikke smeltetabletten gennem folien, da den kan tage skade.
English: • blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
Danish: • blodpropper, eller hvis der er tilfælde af blodpropper i familien, da antipsykotika har været forbundet med dannelsen af blodpropper
English: ABILIFY is for oral use.
Danish: ABILIFY er til oral anvendelse.
English: While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic medicinal products.
Danish: Symptomerne kan forekomme selv ved lave doser, men er imidlertid hyppigere og kraftigere med høj potens antipsykotika og ved højere doser af første generationsantipsykotika.
English: It is ready to use and intended for short-term use only (see section 5.1).
Danish: Opløsningen er klar til brug og er udelukkende beregnet til kortvarigt brug (se pkt.
English: This medicine can be taken regardless of meals.
Danish: Dette lægemiddel kan tages uafhængigt af måltider.
English: Do not stop your treatment just because you feel better.
Danish: Du må ikke stoppe med at tage behandlingen, fordi du har fået det bedre.
English: Simultaneous administration of injectable antipsychotics and parenteral benzodiazepine may be associated with excessive sedation and cardiorespiratory depression.
Danish: Samtidig administration af injektioner af antipsykotika og parenteral benzodiazepin kan være forbundet med voldsom sedering og kardiorespiratorisk depression.
English: Less than 1 % of unchanged aripiprazole was excreted in the urine and approximately 18 % was recovered unchanged in the faeces.
Danish: Mindre end 1 % uomdannet aripiprazol blev udskilt i urinen, og ca. 18 % blev genfundet uomdannet i fæces.
English: In subpopulation analyses on patients with mixed episodes or on patients with severe agitation, a similar pattern of efficacy to the overall population was observed but statistical significance could not be established due to a reduced sample size.
Danish: I subgruppe-analyser af patienter med blandede episoder og patienter med svær agitation sås effektmønstre svarende til den overordnede population, men statistisk signifikans kunne ikke fastslås på grund af reduceret populationsstørrelse.
English: • muscle disorder causing twisting movements (dystonia),
Danish: • muskelforstyrrelse, der giver rykkende bevægelser (dystoni),
English: • feeling restless and unable to keep still, difficulty sitting still,
Danish: • rastløshed og svært ved at forholde sig i ro, svært ved at sidde stille,
English: Aripiprazole administered intramuscularly as a single-dose to healthy subjects is well absorbed and has an absolute bioavailability of 100 %.
Danish: Aripiprazol administreret intramuskulært som enkeltdosis til raske frivillige absorberes godt og har en absolut biotilgængelighed på 100 %.
English: The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disperse in saliva.
Danish: Smeltetabletten skal lægges på tungen, hvor den opløses hurtigt i saliva.
English: • loss of appetite (anorexia),
Danish: • appetitløshed (anoreksi),
English: Caution should be taken when treating patients at higher risk, and a lower starting dose should be considered (e.g., elderly or debilitated patients; see section 4.2).
Danish: Der skal udvises forsigtighed ved behandling af patienter med høj risiko, og en lavere startdosis bør overvejes (f.eks. ældre eller svækkede patienter; se pkt.
English: Contains aspartame and lactose.
Danish: Indeholder aspartam og lactose.
English: A lower dose of 5.25 mg (0.7 mL) may be given, on the basis of individual clinical status, which should also include consideration of medicinal products already administered either for maintenance or acute treatment (see section 4.5).
Danish: Der kan gives lavere dosis, 5,25 mg (0,7 ml), på baggrund af individuel klinisk status, hvor andre medicinske produkter, der allerede administreres i forbindelse med vedligeholdelses- eller akut behandling også indgår i overvejelserne (se afsnit 4.5).
English: - uncontrollable excessive shopping
Danish: - ukontrollerbart overdrevent indkøbsmønster og forbrug,
English: The maximum daily dose of aripiprazole is 30 mg (including all formulations of ABILIFY).
Danish: Maksimal daglig dosis af aripiprazol er 30 mg (inkluderende alle formuleringer af ABILIFY).
English: At therapeutic concentrations, aripiprazole and dehydro-aripiprazole are greater than 99 % bound to serum proteins, binding primarily to albumin.
Danish: Ved terapeutiske koncentrationer bindes aripiprazol og dehydroaripiprazol mere end 99 % til serumproteiner, primært til albumin.
English: Dizziness and vision problems may occur during treatment with this medicine (see section 4).
Danish: Der kan forekomme svimmelhed og synsproblemer ved behandling med dette lægemiddel (se pkt.
English: • onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
Danish: • start eller forværring af sukkersyge, ketoacidose (ketonstoffer i blod og urin) eller koma,
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 aripiprazols toksicitetsprofil sammenlignelig med den, der blev observeret hos voksne dyr, og der var intet, der tydede på neurotoksicitet eller negative virkninger på udviklingen.
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with aripiprazole and preventive measures undertaken.
Danish: Da patienter i behandling med antipsykotika ofte har sygdomsbetingede risikofaktorer for VTE, bør alle mulige risikofaktorer for VTE identificeres før og under behandling med aripiprazol og forebyggende foranstaltninger iværksættes.
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: If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.
Danish: Hvis du udebliver fra en injektionsaftale, skal du kontakte lægen, så I kan lave en ny aftale så hurtigt som muligt.
English: The safety and efficacy of ABILIFY solution for injection has not been evaluated in patients with alcohol or medicinal product intoxication (either with prescribed or illicit medicinal products).
Danish: Sikkerheden og effekten af ABILIFY injektionsvæske, opløsning er ikke evalueret hos patienter med alkohol- eller medicinforgiftning (hverken med ordinerede eller ulovlige midler).
English: - a tendency to wander away.
Danish: - tilbøjelighed til at vandre omkring.
English: At steady state, dehydro-aripiprazole, the active metabolite, represents about 40 % of aripiprazole AUC in plasma.
Danish: Ved steady-state repræsenterer dehydro-aripiprazol, den aktive metabolit, omkring 40 % af aripiprazol AUC i plasma.
English: • past experience with excessive gambling
Danish: • tidligere tilbøjelighed til overdreven spillelyst
English: • blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately),
Danish: • blodpropper i venerne, særligt i benene (symptomer omfatter hævelse, smerter og rødme i benet), der kan vandre gennem blodårerne til lungerne medførende smerte i brystet samt vejrtrækningsbesvær (søg straks læge, hvis du bemærker nogle af disse symptomer),
English: The total dose of ABILIFY (all formulations) should not exceed 30 mg per day.
Danish: Dosis af ABILIFY ialt (alle formuleringer) bør ikke overstige 30 mg per dag.
English: This medicine contains 200 mg of fructose and 400 mg of sucrose in each mL.
Danish: Dette lægemiddel indeholder 200 mg fructose og 400 mg saccharose pr. ml.
English: 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 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: To enhance absorption and minimise variability, injection into the deltoid or deep within the gluteus maximus muscle, avoiding adipose regions, is recommended.
Danish: For at øge absorptionen og minimere forskelle i absorption anbefales det at injicere i deltoidmusklen eller dybt i gluteus maximus-musklen og at undgå områder med fedtaflejringer.
English: Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3 to 5 hours after dosing.
Danish: Aripiprazol absorberes godt, med maksimal plasmakoncentration inden for 3 til 5 timer efter administration.
English: In intravenous reproductive toxicity studies, no new safety concerns were observed at maternal exposures up to 15 (rat) and 29 (rabbit) times human exposure at 30 mg.
Danish: I reproduktionsstudier med intravenøs administration opstod ingen nye sikkerhedsmæssige spørgsmål ved maternel eksponering på op til 15 (rotter) og 29 (kaniner) gange den humane eksponering ved 30 mg.
English: Oral solution 50 mL oral solution 150 mL oral solution 480 mL oral solution
Danish: 50 ml oral opløsning 150 ml oral opløsning 480 ml oral opløsning
English: The singledose pharmacokinetics of aripiprazole was linear and dose-proportional.
Danish: Enkeltdosisfarmakokinetik for aripiprazol var lineær og dosisproportionel.
English: The following symptoms may occur in newborn babies, of mothers that have used ABILIFY 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 ABILIFY i sidste trimester (de sidste tre måneder af graviditeten): rystelser, muskelstivhed og/eller svaghed, døsighed, ophidselse, vejrtrækningsbesvær og besvær med at indtage føde.
English: • high blood sugar,
Danish: • højt blodsukker,
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 hydroxyaripiprazol 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: Extrapyramidal symptoms (EPS)
Danish: Ekstrapyramidale symptomer (EPS)
English: Patients who have taken too much aripiprazole have experienced the following symptoms:
Danish: Patienter, der har taget for meget aripiprazol, har oplevet følgende symptomer:
English: • dry mouth.
Danish: • tør mund.
English: • certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
Danish: • visse antibiotika mod tuberkulose (rifabutin, rifampicin)
English: The aripiprazole AUC in the first 2 hours after an intramuscular injection was 90 % greater than the AUC after the same dose as a tablet; systemic exposure was generally similar between the 2 formulations.
Danish: AUC for aripiprazol er i de første 2 timer efter en intramuskulær injektion 90 % større end AUC efter samme dosis i tabletform; den systemiske optagelse er umiddelbart den samme for de 2 formuleringer.
English: ABILIFY is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Danish: ABILIFY er indiceret til behandling af skizofreni hos voksne og unge i alderen 15 år og opefter.
English: Additionally, aripiprazole and dehydro-aripiprazole did not show potential for altering CYP1A2-mediated metabolism in vitro.
Danish: Derudover viste aripiprazol og dehydro-aripiprazol ikke potentiale til at ændre CYP1A2-medieret metabolisme in vitro.
English: After a 13 to 26-week stabilisation on aripiprazole (2 mg/day to 15 mg/day) patients with a stable response were either maintained on aripiprazole or substituted to placebo for further 16 weeks.
Danish: Efter 13 til 26 ugers stabilisering med aripiprazol (2 mg/dag til 15 mg/dag) fik patienter med stabil respons enten vedligeholdelse med aripiprazol eller blev skiftet over til placebo i yderligere 16 uger.
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 heartbeat.
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: 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: • 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: 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: The point estimate of the hazard ratio (HR) was 0.461 (95 % confidence interval, 0.242 to 0.879) in the full population.
Danish: Punktestimatet for hazard ratioen i hele populationen var 0,461 (95 %-konfidensinterval, 0,242 til 0,879).
English: Sulfobutylether β-cyclodextrin (SBECD) Tartaric acid
Danish: Sulfobutylether β-cyclodextrin (SBECD) Vinsyre
English: ABILIFY contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
Danish: ABILIFY indeholder det aktive stof aripiprazol, som tilhører en gruppe af lægemidler, der kaldes antipsykotika.
English: Patients were 7 to 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 til 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: clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
Danish: rastløshed, en følelse af at være beruset, feber, svedtendens eller muskelstivhed),