FrancophonIA/ELRC3.0 huggingface dataset:
English: • heart problems or have a history of stroke, especially if you know that you have other risks factors for stroke
Danish: • hjerteproblemer eller tidligere slagtilfælde, især hvis du ved, at du har andre risikofaktorer for slagtilfælde
English: Moreover there is also some evidence based on scientific literature that the use of antipsychotics (even second generation antipsychotics like aripiprazole) is associated with an increase in the risk of falls and fractures, especially among the older population.
Danish: Derudover er der også en vis evidens baseret på den videnskabelige litteratur for, at brugen af antipsykotika (selv andengenerations-antipsykotika som aripiprazol) er forbundet med en øget risiko for fald og frakturer, især blandt den ældre del af befolkningen.
English: • akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly)
Danish: • Akatisi (en ubehagelig følelse af indre rastløshed og en ubændig trang til at bevæge dig konstant)
English: This means that the medicine is essentially ‘sodium-free'.
Danish: Dette betyder, at lægemidlet er næsten natriumfrit.
English: Numbers of Subjects at Risk
Danish: Antal patienter i risiko
English: You should not be given Abilify Maintena if you are pregnant unless you have discussed this with your doctor.
Danish: Du må ikke få Abilify Maintena, hvis du er gravid, medmindre du har talt med din læge om det.
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)
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
English: The final efficacy analysis included 403 randomised patients and 80 exacerbations of psychotic symptoms/impending relapse events.
Danish: Den endelige effektanalyse omfattede 403 randomiserede patienter og 80 forekomster af eksacerbation af psykotiske symptomer/imminent recidiv.
English: The 95 % CI (-5.26, 3.99) for the difference in the estimated proportion of patients experiencing impending relapse by end of Week 26 excluded the predefined non-inferiority margin, 11.5 %.
Danish: I 95 %-KI'et (−5,26, 3,99) for differencen i den estimerede andel af patienter, der oplevede imminent recidiv ved udgangen af uge 26, er den prædefinerede noninferioritetsmargin, 11,5 %, ikke medregnet.
English: • loss of strength
Danish: • Tab af styrke
English: • diabetic ketoacidosis (ketones in the blood and urine) or coma
Danish: • Diabetisk ketoacidose (ketoner i blodet og urinen) eller koma
English: Oesophageal dysmotility and aspiration have been associated with the use of aripiprazole.
Danish: Øsofageal dysmotilitet og aspiration har været forbundet med brugen af aripiprazol.
English: • state of indifference with lack of emotion, feelings of emotional and mental discomfort
Danish: • Tilstand af ligegyldighed med følelsesmæssig tomhed, emotionelt og mentalt ubehag
English: Due to its α1-adrenergic receptor antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive medicinal products.
Danish: På grund af dets α1-adrenerge receptorantagonisme kan aripiprazol forstærke virkningen af visse antihypertensiva.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for aripiprazole, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for aripiprazol er CHMP nået frem til følgende videnskabelige konklusioner:
English: Step 5: Procedures after injection
Danish: Trin 5: Procedurer efter injektionen
English: These could be signs of a condition called “tardive dyskinesia”.
Danish: Disse symptomer kan være tegn på en tilstand, der kaldes tardiv dyskinesi
English: It is likely that healthcare professionals would be able to diagnose oculogyric crisis as dystonia and therefore attribute this symptom to aripiprazole, however it is unlikely that patients would be able to link the eye movements to any of the side effects listed in the PIL.
Danish: Det er sandsynligt, at sundhedspersoner vil kunne diagnosticere okulogyr krise som dystoni og derfor forbinde dette symptom med aripiprazol, men det er usandsynligt, at patienter vil være i stand til at forbinde øjenbevægelserne med nogen af de anførte bivirkninger i indlægssedlen.
English: b: Only patients having both baseline and at least one post baseline were included.
Danish: b: Kun patienter, der har både en baseline-værdi og mindst én værdi efter baseline, var inkluderet.
English: It should be noted that impulse-control symptoms can be associated with the underlying disorder; however, in some cases, urges were reported to have stopped when the dose was reduced or the medicinal productation was discontinued.
Danish: Det skal bemærkes, at symptomer på manglende impulskontrol kan være forbundet med den underliggende tilstand; i nogle tilfælde er adfærden ifølge rapporter dog ophørt, når dosen er blevet reduceret eller lægemidlet seponeret.
English: Maternal toxicity occurred at doses similar to those eliciting developmental toxicity.
Danish: Der sås maternel toksicitet ved de samme doser som dem, der medførte udviklingsmæssig toksicitet.
English: • reduced sexual interest (libido is decreased)
Danish: • Nedsat seksuel interesse (nedsat libido)
English: The safety and efficacy of Abilify Maintena in children and adolescents aged 0-17 years have not been established.
Danish: Abilify Maintenas sikkerhed og virkning hos børn og unge i alderen 0-17 år er endnu ikke klarlagt.
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, andre antipsykotika, ATC-kode:N05AX12
English: Given that dystonia is a well-known side effect of this drug and the large number of reported cases it seems likely that aripiprazole can cause oculogyric crisis.
Danish: Da dystoni er en kendt bivirkning ved dette lægemiddel, og da antallet af indberettede tilfælde er stort, virker det sandsynligt, at aripiprazol kan forårsage okulogyr krise.
English: Other atypical antipsychotics already have a warning in EU SmPC.
Danish: Andre atypiske antipsykotika har også en advarsel i det europæiske produktresumé.
English: Abilify Maintena is only intended for intramuscular use and should not be administered intravenously or subcutaneously.
Danish: Abilify Maintena er udelukkende beregnet til intramuskulær brug og må ikke administreres intravenøst eller subkutant.
English: If 4th or subsequent doses are missed (i.e., after attainment of steady state) and time since last injection is:
Danish: Hvis den 4. dosis eller efterfølgende doser springes over (dvs. efter opnåelse af steady state), og tiden siden seneste injektion er:
English: Blood pressure-lowering medicines: Abilify Maintena may increase the effect of medicines used to lower the blood pressure.
Danish: Blodtrykssænkende medicin: Abilify Maintena kan øge virkningen af medicin, der sænker blodtrykket.
English: Use in patients who are in an acutely agitated or severely psychotic state
Danish: Brug til patienter, som er i en akut agiteret eller svær psykotisk tilstand
English: If 2nd or 3rd dose is missed and time since last injection is:
Danish: Hvis den 2. eller 3. dosis springes over, og tiden siden seneste injektion er:
English: In these patients dosing should be managed cautiously.
Danish: Hos disse patienter bør dosering foretages med forsigtighed.
English: The toxicological profile for aripiprazole administered to experimental animals by intramuscular injection is generally similar to that seen following oral administration at comparable plasma levels.
Danish: Den toksikologiske profil af aripiprazol administreret til forsøgsdyr ved intramuskulær injektion er generelt den samme som den, der ses efter oral administration med sammenlignelige plasmaniveauer.
English: • high blood pressure
Danish: • Højt blodtryk
English: • difficulty controlling core body temperature or overheating
Danish: • Svært kontrollerbar kropstemperatur eller overophedning
English: • dizziness when getting up from a lying or sitting position due to a drop in blood pressure
Danish: • Svimmelhed, når man rejser sig op fra liggende eller siddende stilling, på grund af et fald i blodtrykket
English: • high blood sugar
Danish: • Højt blodsukker
English: Steady state concentrations for the typical subject were attained by the fourth dose for both sites of administration.
Danish: Steady state-koncentrationen blev typisk nået ved fjerde dosis for begge injektionssteder.
English: Oculogyric crisis: From post-marketing sources, there were 20 reports of oculogyric crisis during the interval (11 serious) and 244 reports cumulatively (92 serious).
Danish: Okulogyr krise: Efter markedsføring er der foretaget 20 indberetninger af okulogyr krise i løbet af perioden (11 alvorlige) og 244 indberetninger kumulativt (92 alvorlige).
English: Full instructions for use and handling of Abilify Maintena are provided in the package leaflet (information intended for healthcare professionals).
Danish: Fuldstændig instruktion i brug og håndtering af Abilify Maintena kan findes i indlægssedlen (oplysninger til læger og sundhedspersonale).
English: • spontaneous flow of milk from the breasts (galactorrhoea)
Danish: • Spontant flow af mælk fra brysterne (galaktorré)
English: P-values were derived from comparison for change from baseline within analysis of covariance model with treatment as term and baseline as covariate.
Danish: P-værdierne blev udledt ved sammenligning af ændringer fra baseline i en kovarians-analysemodel med behandling som faktor og baseline som kovariat.
English: Injection site pain (incidence 5.1 %), had a median onset on day 2 after the injection and a median duration of 4 days.
Danish: Smerter på injektionsstedet (incidens 5,1 %) havde en median debut på dag 2 efter injektionen og en median varighed på 4 dage.
English: Close supervision of high risk patients should accompany antipsychotic treatment.
Danish: Højrisikopatienter skal overvåges nøje i forbindelse med antipsykotisk behandling.
English: • kidney stones, sugar (glucose) in urine
Danish: • Nyresten, sukker (glukose) i urinen
English: The analysis included only subjects who were randomly assigned to treatment, given at least one injection, had baseline and at least one post-baseline efficacy assessment.
Danish: Analysen omfattede kun forsøgspersoner, der blev randomiseret til behandling, fik mindst én injektion, havde en baseline-værdi og mindst én effektvurdering post-baseline.
English: • mental disorder characterized by defective or lost contact with reality
Danish: • Mental forstyrrelse med dårlig eller ingen kontakt med virkeligheden
English: After that, treatment is given with injections of Abilify Maintena unless your doctor tells you otherwise.
Danish: Derefter får du behandlingen i form af injektioner med Abilify Maintena, medmindre din læge siger noget andet.
English: It should be administered once monthly as a single injection (no sooner than 26 days after the previous injection).
Danish: Det skal administreres én gang om måneden som en enkelt injektion (der skal gå mindst 26 dage mellem hver injektion).
English: In addition, reports of accidental overdose with aripiprazole alone (up to 195 mg) in children have been received with no fatalities.
Danish: Derudover er der rapporteret om utilsigtet overdosering af aripiprazol alene (op til 195 mg) hos børn.
English: Hypertension Orthostatic hypotension Blood pressure increased
Danish: Hypertension Ortostatisk hypotension Forhøjet blodtryk
English: • increased blood fats such as high cholesterol, high triglycerides and also low level of cholesterol and low level of triglycerides
Danish: • Forhøjet niveau af fedt i blodet, fx højt niveau af kolesterol og triglycerider, men også lavt niveau af kolesterol og lavt niveau af triglycerider
English: Step 4: Procedures after injection
Danish: Trin 4: Procedurer efter injektionen
English: The safety profile was consistent with that known to Abilify Maintena.
Danish: Sikkerhedsprofilen var konsistent med den kendte for Abilify Maintena.
English: Abilify Maintena contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.
Danish: Abilify Maintena indeholder det aktive stof aripiprazol, som tilhører en gruppe af lægemidler, der kaldes antipsykotika.
English: Receiving Abilify Maintena with some medicines may mean the doctor will need to change your dose of Abilify Maintena or the other medicines.
Danish: Hvis du får Abilify Maintena sammen med visse andre lægemidler, kan det være, at lægen skal ændre din dosis af Abilify Maintena eller af de andre lægemidler.
English: Non-clinical safety data for orally administered aripiprazole 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: Prækliniske data for oralt administreret aripiprazol viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: In case of dose dumping, aripiprazole concentrations are predicted to descend rapidly to the upper limit of the therapeutic window after approximately 3 days.
Danish: Hvis der sker dosisdumping, forventes aripiprazolkoncentrationen at falde hurtigt til den øvre grænse for det terapeutiske vindue efter ca. 3 dage.
English: After reconstitution
Danish: Efter rekonstitution:
English: Figure 1 Kaplan-Meier Product Limit Plot for Time to Exacerbation of Psychotic Symptoms/Impending Relapse
Danish: Figur 1 Kaplan-Meier-diagram (Product Limit), der viser tiden til eksacerbation af psykotiske symptomer/imminent recidiv
English: Potential for other medicinal products to affect aripiprazole
Danish: Andre lægemidler, der kan påvirke optagelsen af aripiprazol
English: If there are adverse reactions with the 400 mg dosage, reduction of the dose to 300 mg once monthly should be considered.
Danish: Hvis der opstår bivirkninger med dosen på 400 mg, skal det overvejes at reducere dosis til 300 mg pr. måned.
English: • low level of a specific type of white blood cells (neutropenia), low haemoglobin or red blood cell count, low level of blood platelets
Danish: • Lavt niveau af en særlig type hvide blodlegemer (neutropeni), lavt niveau af hæmoglobin eller røde blodlegemer, lavt niveau af blodplader
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 anomale sammentrækninger af muskelgrupper, hos modtagelige individer i de første par dage af behandlingen.
English: The suspension should be injected slowly as a single injection (doses must not be divided) into the gluteal or deltoid muscle.
Danish: Suspensionen skal injiceres langsomt som en enkelt injektion (dosen må ikke deles) i gluteal- eller deltoidmusklen.
English: No interaction studies have been performed with Abilify Maintena.
Danish: Der er ikke udført interaktionsstudier med Abilify Maintena.
English: The occurrence of suicidal behaviour is inherent in psychotic illnesses, and in some cases has been reported early after initiation or switch of antipsychotic treatment, including treatment with aripiprazole (see section 4.8).
Danish: Forekomsten af suicidal adfærd er et iboende træk ved psykotiske lidelser og er i nogle tilfælde blevet rapporteret kort tid efter start eller skift af antipsykotisk behandling, herunder behandling med aripiprazol (se pkt.
English: After multiple dose administration of Abilify Maintena, dehydro-aripiprazole, the active metabolite, represents about 29.1-32.5 % of aripiprazole AUC in plasma.
Danish: Efter administration af flere doser Abilify Maintena udgør dehydroaripiprazol, den aktive metabolit, ca. 29,1-32,5 % af aripiprazols AUC i plasma.
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 sulfatkonjugater af hydroxyaripiprazol i den humane galde ved den højeste foreslåede dosis (30 mg/dag) var dog kun 6 % af de koncentrationer, der sås i galden hos aber i 39ugers forsøget, og de lå et godt stykke under (6 %) grænserne for opløseligheden in vitro.
English: If you notice you are gaining weight, develop unusual movements, experience sleepiness that interferes with normal daily activities, any difficulty in swallowing or have allergic symptoms, please talk to your doctor immediately.
Danish: Hvis du bemærker, at du tager på i vægt, får usædvanlige bevægelser, bliver så døsig, at det har indvirkning på dine daglige aktiviteter, får problemer med at synke eller får allergiske symptomer, så skal du tale med din læge med det samme.
English: Patients fulfilling the oral stabilisation requirement in the Oral Stabilisation Phase were assigned to receive, in a single-blind fashion, Abilify Maintena and began an Abilify Maintena Stabilisation Phase for a minimum of 12 weeks and a maximum of 36 weeks.
Danish: Patienter, der opfyldte kravene til oral stabilisering i den orale stabiliseringsfase, blev allokeret til at få Abilify Maintena og påbegyndte en enkeltblindet Abilify Maintena-stabiliseringsfase på mindst 12 og højst 36 uger.
English: Do not massage the injection site.
Danish: Du må ikke gnide på injektionsstedet.
English: The PIL for these products have similar warnings regarding muscle spasms, swallowing difficulty and breathing difficulty but again no mention of eye movement disorders.
Danish: Indlægssedlen for disse lægemidler har lignende advarsler vedrørende muskelspasmer, synkebesvær og vejrtrækningsbesvær, men nævner heller ikke her øjenbevægelsesforstyrrelser.
English: However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported.
Danish: Forhøjet kreatinkinase og rabdomyolose, der ikke nødvendigvis er forbundet med NMS, er dog også rapporteret.
English: Look for signs or symptoms of inadvertent intravenous administration.
Danish: Tjek for tegn og symptomer på utilsigtet intravenøs indgivelse.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Abilify Maintena in all subsets of the paediatric population in schizophrenia (see section 4.2).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Abilify Maintena i alle undergrupper af den pædiatriske population med skizofreni (se pkt.
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 (see section 4.8).
Danish: Hvis en patient får tegn og symptomer, som tyder på NMS, eller får uforklarlig høj feber uden yderligere kliniske manifestationer af NMS, skal alle antipsykotika, inklusive aripiprazol, seponeres (se pkt.
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 en enkelt oral dosis af 14C-mærket aripiprazol blev ca. 27 % af den administrerede radioaktivitet genfundet i urinen og ca. 60 % i fæces.
English: Water c) Slowly inject the solvent into the vial containing the powder.
Danish: Vand c) Sprøjt langsomt solvensen ned i hætteglasset med pulver.
English: • neuroleptic malignant syndrome ( a syndrome with symptoms such as fever, muscle stiffness,
Danish: • Neuroleptisk malignt syndrom (et syndrom med symptomer som f.eks. feber, muskelstivhed,
English: • pain at the injection site, hardening of the skin at the injection site
Danish: • Smerter ved injektionsstedet, fortykkelse af huden omkring injektionsstedet
English: Your doctor will alternate the injections between your right and left side.
Danish: Lægen vil skiftevis give dig injektionen i højre og venstre side.
English: This trial consisted of a screening phase and 3 treatment phases: Conversion Phase, Oral Stabilisation Phase, and Double-blind, Active-controlled Phase.
Danish: Studiet bestod af en screeningsfase og 3 behandlingsfaser: En konverteringsfase, en oral stabiliseringsfase og en dobbeltblindet, aktivkontrolleret fase.
English: • muscle movements that you cannot control such as grimacing, lip-smacking and tongue movements.
Danish: • Muskelbevægelser, du ikke kan kontrollere, fx grimasser og smæld med læberne og tungen.
English: During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks.
Danish: Under antipsykotisk behandling kan det tage fra flere dage til nogle uger, før patientens kliniske tilstand bedres.
English: In this PSUR, there are 15 spontaneous reports of oculogyric crisis (8 serious) in the interval and 223 cumulatively (78 serious) for the oral formulations, comparing to 5 spontaneous reports of oculogyric crisis (3 serious) in the interval and 21 cumulatively (14 serious) for the prolonged-release suspension for injection.
Danish: I denne PSUR er der 15 spontane indberetninger af okulogyr krise (8 alvorlige) i perioden og 223 kumulativt (78 alvorlige) for de orale formuleringer sammenholdt med 5 spontane indberetninger af okulogyr krise (3 alvorlige) i perioden og 21 kumulativt (14 alvorlige) for depotinjektionsvæske, suspension.
English: From a microbiological point of view, unless the method of opening/ reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør præparatet anvendes med det samme, medmindre åbnings/rekonstitutionsmetoden udelukker risiko for kontaminering med mikroorganismer.
English: Aripiprazole also exhibited moderate binding affinity for the serotonin reuptake site and no appreciable affinity for cholinergic muscarinic receptors.
Danish: Aripiprazol har også udvist moderat bindingsaffinitet til serotonin reuptake-sitet og ingen målbar affinitet til kolinerge muskarine receptorer.
English: They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis)
Danish: Dette kan skyldes en unormal nedbrydning af musklerne, som kan være livstruende og medføre nyreproblemer (en tilstand, der kaldes rabdomyolyse)
English: Additionally, it is known that the use of aripiprazole is associated with other ADR that may predispose to falls, such as somnolence, sedation, dizziness or hypotension.
Danish: Desuden er det kendt, at brugen af aripiprazol er forbundet med andre bivirkninger, der kan prædisponere for fald, f.eks. somnolens, sedation, svimmelhed eller hypotension.
English: Do not use this medicine after the expiry date which is stated on the carton and the vial.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: Based on results from trials with oral administration of aripiprazole, aripiprazole is widely distributed throughout the body with an apparent volume of distribution of 4.9 l/kg, indicating extensive extravascular distribution.
Danish: Baseret på resultater fra studier med oral administration af aripiprazol fordeles aripiprazol i stor udstrækning i kroppen med en tilsyneladende fordelingsvolumen på 4,9 l/kg, hvilket indikerer omfattende ekstravaskulær fordeling.
English: Aripiprazole is extensively metabolised by the liver primarily by three biotransformation pathways: dehydrogenation, hydroxylation, and N-dealkylation.
Danish: Aripiprazol metaboliseres i stor udstrækning i leveren via tre biotransformationsveje: dehydrogenering, hydroxylering og N-dealkylering.
English: > 5 weeks
Danish: > 5 uger
English: • drug withdrawal symptoms in new-born infant
Danish: • Abstinenssymptomer hos nyfødte