FrancophonIA/ELRC3.0 huggingface dataset:
English: In repeated 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 events on development.
Danish: I studier med gentagne doser hos juvenile rotter og hunde var aripiprazols toksicitetsprofil sammenlignelig med aripiprazols toksicitetsprofil hos voksne dyr, og der var ingen tegn på neurotoksicitet eller uønskede virkninger på udviklingen.
English: Oral aripiprazole 10-30 mg/day (n = 266)
Danish: Oralt aripiprazol 10-30 mg/dag (n = 266)
English: H. Lundbeck A/S Ottiliavej 9, 2500 Valby Denmark
Danish: H. Lundbeck A/S Ottiliavej 9, 2500 Valby Danmark
English: The reconstituted medicine is a white to off-white, fluid suspension.
Danish: Det rekonstituerede præparat er en hvid til off-white flydende suspension.
English: • low levels of white blood cells
Danish: • Lavt niveau af hvide blodlegemer
English: Additionally, from the EudraVigilance database, at least one case is retrieved with a positive rechallenge, which conveys a probable causal association of aripiprazole use with oculogyric crisis.
Danish: Derudover er der identificeret i hvert fald ét tilfælde med positiv rechallenge fra EudraVigilance-databasen, hvilket tyder på en mulig årsagssammenhæng mellem brug af aripiprazol og okulogyr krise.
English: For patients who have never taken aripiprazole, tolerability with oral aripiprazole must occur prior to initiating treatment with Abilify Maintena.
Danish: For så vidt angår patienter, der ikke tidligere har taget aripiprazol, skal deres tolerabilitet over for aripiprazol fastslås, før behandling med Abilify Maintena påbegyndes.
English: In this context, and given the seriousness of the consequences of falls, especially in elderly, the PRAC believes that an update of the Product Information with inclusion of a warning in section 4.4 of the SmPC is recommended.
Danish: I denne sammenhæng og i betragtning af alvoren af konsekvenserne af fald, især hos ældre, er PRAC af den opfattelse, at det er nødvendigt at opdatere pkt.
English: Photosensitivity reaction Hyperhidrosis
Danish: Fotosensibilitetsreaktion Hyperhidrose
English: The recommended and starting dose is 400 mg unless your doctor decided to give you a lower starting or follow up dose (300 mg, 200 mg or 160 mg).
Danish: Lægen kan dog beslutte at give dig en lavere startdosis eller en lavere opfølgningsdosis (300 mg, 200 mg eller 160 mg).
English: Multipack Bundle pack of 3 single packs.
Danish: Multipakning Multipakning med 3 enkeltpakninger.
English: Based on the available data, this condition should be listed in all aripiprazole containing products formulations.
Danish: På grundlag af de tilgængelige data bør denne tilstand anføres for alle aripiprazol-holdige lægemiddelformuleringer.
English: Multipack: Three single packages, each containing:
Danish: Multipakning: Tre enkeltpakninger, der hver indeholder
English: Developmental toxicity, including dose-dependent delayed foetal ossification and possible teratogenic effects, were observed in rats at doses resulting in sub-therapeutic exposures (based on AUC) and in rabbits at doses resulting in exposures approximately 3 and 11 times the mean steady-state AUC at the maximum recommended clinical dose.
Danish: Udviklingstoksicitet, herunder dosisafhængig forsinket føtal ossifikation og mulig teratogen effekt, blev observeret hos rotter ved doser, der førte til subterapeutiske eksponeringer (baseret på AUC), og hos kaniner ved doser, der førte til eksponeringer på ca. 3 og 11 gange det gennemsnitlige steady state-AUC ved den maksimale anbefalede kliniske dosis.
English: d) Withdraw air to equalise the pressure in the vial by pulling back slightly on the plunger.
Danish: d) Træk luft ud for at udligne trykket i hætteglasset ved at trække stemplet en lille smule tilbage.
English: It is important that you carry on receiving Abilify Maintena for as long as your doctor has told you to.
Danish: Det er vigtigt, at du fortsætter med at få Abilify Maintena i så lang tid, som lægen har sagt, at du skal have det.
English: Concomitant administration of Abilify Maintena and other inducers of CYP3A4 (such as rifampicin, rifabutin, phenytoin, phenobarbital, primidone, efavirenz, nevirapine and St. John's Wort) may be expected to have similar effects.
Danish: Samtidig administration af Abilify Maintena og andre CYP3A4-induktorer (som fx rifampicin, rifabutin, phenytoin, phenobarbital, primidon, efavirenz, nevirapin og perikon) kan forventes at have lignende virkninger.
English: Any excess should be discarded.
Danish: Overskydende solvens skal kasseres.
English: After the first injection, treatment with 10 mg to 20 mg oral aripiprazole per day should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.
Danish: Efter den første injektion skal der fortsat behandles med 10 til 20 mg oralt aripiprazol pr. dag i 14 dage i træk for at opretholde de terapeutiske aripiprazol-koncentrationer i starten af behandlingen.
English: Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia.
Danish: Aripiprazol skal anvendes med forsigtighed hos patienter med risiko for aspirationspneumoni.
English: In three placebo-controlled trials of oral aripiprazole in elderly patients with psychosis associated with Alzheimer's disease (n = 938; mean age: 82.4 years; range: 56-99 years), patients treated with aripiprazole were at an increased risk of death compared to placebo.
Danish: I tre placebo-kontrollerede studier af oralt aripiprazol hos ældre patienter med Alzheimer-relateret psykose (n = 938; gennemsnitsalder: 82,4 år; aldersspænd: 56-99 år) havde de patienter, der blev behandlet med aripiprazol, øget dødsrisiko i forhold til de patienter, der fik placebo.
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 (see section 4.8).
Danish: Da patienter, der er i behandling med antipsykotika, ofte har sygdomsbetingede risikofaktorer for VTE, skal alle mulige risikofaktorer for VTE identificeres før og under behandling med aripiprazol, og der skal iværksættes forebyggende foranstaltninger (se pkt.
English: Management of overdose should concentrate on supportive therapy, maintaining an adequate airway, oxygenation and ventilation, and management of symptoms.
Danish: Håndtering af overdosering skal omfatte understøttende behandling, opretholdelse af frie luftveje, sikring af tilstrækkelig iltning og ventilering samt behandling af symptomerne.
English: • spasm of the muscles around the voice box
Danish: • Spasmer i musklerne omkring strubehovedet
English: Mean baseline (SD)
Danish: Middelværdi ved baseline (SD)
English: Abilify Maintena should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted.
Danish: Abilify Maintena bør ikke bruges til behandling af tilstande med akut agitation eller svær psykose, når omgående symptomkontrol er påkrævet.
English: Pain in extremity Arthralgia
Danish: Smerter i ekstremiteterne Artralgi
English: On the basis of the scientific conclusions for aripiprazole the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing aripiprazole is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for aripiprazol er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder aripiprazol, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Less often substances such as propranolol and benzodiazepines (clonazepam and diazepam) were administered to control akathisia.
Danish: Stoffer som fx propranolol og benzodiazepiner (clonazepam og diazepam) blev mindre hyppigt administreret for at kontrollere akatisien.
English: > 6 weeks
Danish: > 6 uger
English: Do not inject into an area with signs of inflammation, skin damage, lumps and/or bruises.
Danish: Du må ikke injicere i et område, hvor der er tegn på inflammation, beskadiget hud, buler og/eller blå mærker.
English: The reconstituted product suspension should appear to be a uniform, homogeneous suspension that is opaque and milky-white in colour.
Danish: Den rekonstituerede suspension skal være ensartet og homogen, uigennemsigtig og mælkehvid.
English: Step 4: Injection procedure a) Detach the luer lock syringe containing the recommended volume of reconstituted Abilify Maintena suspension from the vial.
Danish: Trin 4: Injektionsprocedure a) Fjern luer lock-sprøjten med den anbefalede mængde Abilify Maintena-suspension fra hætteglasset.
English: Solvent for Abilify Maintena Water for injections
Danish: Solvens til Abilify Maintena Vand til injektionsvæsker
English: • muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine.
Danish: • Muskelsvækkelse, ømhed eller smerter, især hvis du samtidig føler dig utilpas, har høj feber eller din urin er mørk.
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 punkt 6).
English: Libido decreased Mood altered
Danish: Nedsat libido Humørsvingninger
English: Hyperglycaemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with aripiprazole.
Danish: Der er rapporteret om hyperglykæmi, som i nogle tilfælde har været ekstrem og forbundet med ketoacidose eller hyperosmolær koma eller død, hos patienter, der er blevet behandlet med aripiprazol.
English: g) Visually inspect the reconstituted suspension for particulate matter and discolouration prior to administration.
Danish: g) Kontrollér den rekonstituerede suspension for partikler og misfarvning før indgivelse.
English: The potentially medically serious signs and symptoms reported included somnolence, transient loss of consciousness and extrapyramidal symptoms.
Danish: De potentielt medicinsk alvorlige tegn og symptomer, der er rapporteret, er døsighed, forbigående tab af bevidsthed og ekstrapyramidale symptomer.
English: Agitation Anxiety Restlessness Insomnia
Danish: Agitation Angst Rastløshed Søvnløshed
English: Following multiple intramuscular doses, the plasma concentrations of aripiprazole gradually rise to a maximum plasma concentration at a median tmax of 7 days for the gluteal muscle and 4 days for the deltoid muscle.
Danish: Efter flere intramuskulære doser steg plasmakoncentrationen af aripiprazol gradvist til den maksimale plasmakoncentration med en median tmax på henholdsvis 7 dage (glutealmusklen) og 4 dage (deltoidmusklen).
English: • movement problems
Danish: • Bevægelsesproblemer
English: If you are receiving Abilify Maintena, your doctor will discuss with you whether you should breastfeed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding.
Danish: Hvis du får Abilify Maintena, 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: Aripiprazole exhibited antagonist properties in animal models of dopaminergic hyperactivity and agonist properties of dopaminergic hypoactivity.
Danish: Aripiprazol har udvist antagonistiske egenskaber i dyremodeller med dopaminerg hyperaktivitet og agonistiske egenskaber i dyremodeller med dopaminerg hypoaktivitet.
English: Shelf-life after reconstitution: 4 hours below 25 °C Do not store the reconstituted suspension in the syringe.
Danish: Opbevaringstid efter rekonstitution: 4 timer ved temperaturer under 25 °C Opbevar ikke den rekonstituerede suspension i sprøjten.
English: Attach the adaptersyringe assembly to the vial by holding the outside of the adapter and pushing the adapter's spike firmly through the rubber stopper, until the adapter snaps in place.
Danish: Fastgør adapteren med isat sprøjte på hætteglasset ved at holde fast på ydersiden af adapteren og skubbe adapterens spids gennem gummiproppen med en fast bevægelse, indtil adapteren klikker på plads.
English: The PSUR for the brand leader, Abilify and Abilify Maintena, gathers data from the immediate-realease formulations and the prolonged-release suspension for injection.
Danish: PSUR'en for det førende produkt, Abilify og Abilify Maintena, samler data fra formuleringerne med øjeblikkelig frigivelse og depotinjektionsvæske, suspension.
English: The AUC and Cmax of dehydroaripiprazole increased by 77 % and 43 %, respectively.
Danish: AUC og Cmax for dehydroaripiprazol steg med henholdsvis 77 % og 43 %.
English: 20 seconds c) Visually inspect the syringe for particulate matter and discoloration prior to administration.
Danish: 20 sekunder c) Kontrollér sprøjtens indhold for partikler og misfarvning før indgivelse.
English: The following symptoms may occur in new-born babies, of mothers that have received Abilify Maintena 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 opstå hos nyfødte, hvis deres mor har fået Abilify Maintena det sidste trimester (de sidste tre måneder af graviditeten): rysten, muskelstivhed og/eller muskelsvækkelse, søvnighed, uro, vejrtrækningsproblemer og spisebesvær.
English: • an acutely agitated state or a severely psychotic state
Danish: • en akut opstået ophidset tilstand eller en svær psykotisk tilstand
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Danish: De kliniske manifestationer af NMS er hyperpyreksi, muskelrigiditet, ændret mental status og tegn på autonom ustabilitet (uregelmæssig puls eller ustabilt blodtryk, takykardi, svedtendens og hjertearytmi).
English: • abnormal hair loss
Danish: • Unormalt hårtab
English: Musculoskeletal stiffness
Danish: Muskuloskeletal stivhed
English: Aripiprazole is the predominant medicinal product moiety in systemic circulation.
Danish: Aripiprazol er den dominerende lægemiddel-fraktion i det systemiske kredsløb.
English: It has been proposed that aripiprazole's efficacy in schizophrenia is mediated through a combination of partial agonism at dopamine D2 and serotonin 5-HT1A receptors and antagonism at serotonin 5-HT2A receptors.
Danish: Det er blevet foreslået, at aripiprazols effekt ved skizofreni medieres gennem en kombination af partiel agonisme på dopamin D2- og serotonin 5-HT1A-receptorer og antagonisme på serotonin 5-HT2Areceptorer.
English: Animal studies could not exclude potential developmental toxicity (see section 5.3).
Danish: I dyreforsøg har udviklingstoksicitet ikke kunnet udelukkes (se pkt.
English: The rate of death in oral aripiprazole-treated patients was 3.5 % compared to 1.7 % in placebo.
Danish: Mortaliteten blandt patienter behandlet med oralt aripiprazol var 3,5 % sammenholdt med 1,7 % i placebo-gruppen.
English: Venous thromboembolism (including pulmonary embolism and deep vein thrombosis)
Danish: Venøs tromboemboli (inklusive lungeemboli og dyb venetrombose)
English: In clinical trials of treatment with oral aripiprazole, the incidence of QT prolongation was comparable to placebo.
Danish: I kliniske studier af oralt aripiprazol var incidensen af QT-forlængelse sammenlignelig med placebo.
English: Abilify Maintena comes as a powder which your doctor or nurse will make into a suspension.
Danish: Abilify Maintena er et pulver, som lægen eller sygeplejersken opblander til en suspension.
English: • gastroesophageal reflux disease.
Danish: • Gastroøsofageal reflukssygdom.
English: • panic reaction
Danish: • Panikreaktioner
English: Based on results of a full range of standard genotoxicity tests, aripiprazole was considered nongenotoxic.
Danish: Ud fra resultaterne af en fuld række genotoksiske standardundersøgelser vurderes det, at aripiprazol ikke er genotoksisk.
English: > 4 weeks and < 6 weeks
Danish: > 4 uger og < 6 uger
English: Dyskinesia Sedation Somnolence Dizziness Headache
Danish: Dyskinesi Sedation Døsighed Svimmelhed Hovedpine
English: f) Place and hold the vial of the reconstituted suspension on a hard surface.
Danish: f) Anbring og fasthold hætteglasset med rekonstitueret suspension på en hård bordplade.
English: The primary endpoint (change in PANSS total score from baseline to week 10) showed superiority of Abilify Maintena (n = 167) over placebo (n = 172).
Danish: Det primære endepunkt (ændring i samlet PANSS-score fra baseline til uge 10) viste, at Abilify Maintena (n = 167) var superiort i forhold til placebo (n = 172).
English: The AUC and Cmax of dehydroaripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively.
Danish: AUC og Cmax for dehydroaripiprazol, den aktive metabolit, faldt med henholdsvis 32 % og 47 %.
English: A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from aripiprazole therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med aripiprazol seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: a tendency to wander away
Danish: Tilbøjelighed til at vandre omkring
English: 87 cases had medical history of confounding risk factors such as balance disorders, loss of consciousness, syncope, somnolence, extrapyramidal disorder, femoral fracture, alcohol abuse, bundle branch block, osteoporosis, knee arthroplasty, spinal fusion surgery, road traffic accident, fall, transient ischemic attack, cerebrovascular accident, head injury and dementia with Lewy bodies and concomitant therapy with risperidone, quetiapine fumarate, clonazepam, Latuda, valium was a confounding factor in 172 cases.
Danish: 87 tilfælde havde en anamnese med forstyrrende risikofaktorer som f.eks. balanceforstyrrelser, svækket bevidsthed, besvimelse, somnolens, ekstrapyramidale forstyrrelser, femur-fraktur, alkoholmisbrug, grenblok, osteoporose, knæartroplastik, spondylodese, trafikulykke, fald, transitorisk iskæmisk attak, cerebrovaskulær hændelse, hovedskade og Lewi Body-demens, og samtidig behandling med risperidon, quetiapinfumarat, clonazepam, Latuda og valium var en forstyrrende faktor i 172 tilfælde.
English: Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection if the syringe has been left for more than 15 minutes.
Danish: Ryst sprøjten kraftigt i mindst 20 sekunder for at omryste suspensionen inden injektion, hvis sprøjten har ligget klar i mere end 15 minutter.
English: Following any confirmed or suspected overdose with aripiprazole, close medical supervision and monitoring should continue until the patient recovers.
Danish: Efter en bekræftet eller formodet overdosering af aripiprazol er tæt lægelig observation og overvågning påkrævet, indtil patienten kommer sig.
English: • difficulty sleeping (insomnia)
Danish: • Søvnløshed (insomni)
English: Talk to your doctor about the best way to feed your baby if you are receiving Abilify Maintena.
Danish: Tal med lægen om, hvordan du bedst kan ernære dit barn, hvis du får Abilify Maintena.
English: b) Select one of the following hypodermic safety needles depending on the injection site and patient's weight and attach the needle to the luer lock syringe containing the suspension for injection.
Danish: b) Tag en af de medfølgende hypodermiske sikkerhedskanyler alt efter injektionssted og patientens vægt og fastgør kanylen på luer lock-sprøjten med injektionssuspensionen.
English: New-born infants exposed to antipsychotics (including aripiprazole) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Danish: Nyfødte, der har været eksponeret for antipsykotika (herunder aripiprazol) i graviditetens tredje trimester, har risiko for at få bivirkninger, herunder ekstrapyramidale symptomer og/eller abstinenssymptomer, der kan variere i sværhedsgrad og varighed efter fødslen.
English: • accidental inhalation of food with risk of pneumonia (lung infection)
Danish: • Utilsigtet inhalering af mad med risiko for lungebetændelse
English: INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS
Danish: OPLYSNINGER TIL LÆGER OG SUNDHEDSPERSONALE
English: 0.8 ml e) Wipe the top of the vial of the reconstituted suspension with a sterile alcohol swab.
Danish: 0,8 ml e) Aftør toppen på hætteglasset med rekonstitueret suspension med en steril spritserviet.
English: Twist + Pull Off
Danish: Drej + tag af
English: If you notice any of these symptoms seek medical advice immediately.
Danish: Hvis du bemærker et af disse symptomer, skal du straks kontakte lægen.
English: After administration of multiple dose of 400 mg or 300 mg of Abilify Maintena, the mean aripiprazole terminal elimination half-life is respectively 46.5 and 29.9 days presumably due to absorption ratelimited kinetics.
Danish: Efter administration af flere doser Abilify Maintena 400 eller 300 mg er den gennemsnitlige terminale halveringstid for aripiprazol på henholdsvis 46,5 og 29,9 dage, antagelig på grund af den begrænsede absorptionshastighed.
English: Similar to the PANSS Total Score, both the PANSS positive and negative subscale scores also showed an improvement (decrease) from baseline over time.
Danish: Ligesom for den samlede PANSS-score sås der over tid forbedringer (fald) i scores for både den positive og den negative PANSS-subskala i forhold til baseline.
English: Single pack
Danish: Enkeltpakning
English: It is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Danish: Det anvendes til behandling af skizofreni - en sygdom, der gør, at man fx hører, ser eller mærker ting, som ikke eksisterer, er mistroisk, har vrangforestillinger, taler og opfører sig usammenhængende og er følelsesmæssigt mat.
English: clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
Danish: rastløshed, fornemmelse af at være beruset, feber, svedtendens eller stive muskler)
English: • involuntary loss of urine (incontinence)
Danish: • Ufrivillig vandladning (inkontinens)
English: Aripiprazole exhibits high binding affinity in vitro for dopamine D2 and D3, serotonin 5-HT1A and 5-HT2A receptors and has moderate affinity for dopamine D4, serotonin 5-HT2C and 5-HT7, alpha-1 adrenergic, and histamine H1 receptors.
Danish: Aripiprazol udviser høj bindingsaffinitet in vitro til dopamin D2- og D3-, serotonin 5-HT1A- og 5-HT2A-receptorer og har moderat affinitet til dopamin D4-, serotonin 5-HT2C- og 5-HT7-receptorer, alfa-1-adrenerge receptorer og histamin H1-receptorer.
English: • a combination of any of these symptoms: excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, fever, weakness, irritability, aggression, anxiety, increase in blood pressure, or seizures that can lead to unconsciousness.
Danish: • En kombination af nogen af disse symptomer: Ekstrem søvnighed, svimmelhed, forvirring, desorientering, talebesvær, gangbesvær, muskelstivhed eller rysten, feber, svaghed, irritabilitet, aggression, angst, forhøjet blodtryk eller krampeanfald, der kan føre til bevidstløshed.
English: There was a statistically significant treatment difference in favour of Abilify Maintena 400 mg/300 mg compared to placebo at week 10 (+7.1, p < 0.0001, 95 % CI: 4.1, 10.1 using an ANCOVA model (LOCF)).
Danish: Der var en statistisk signifikant behandlingsforskel til fordel for Abilify Maintena 400 mg/300 mg sammenlignet med placebo ved uge 10 (+7,1; p < 0,0001; 95 % KI: 4,1-10,1 beregnet ved ANCOVA-modellen (LOCF)).