FrancophonIA/ELRC3.0 huggingface dataset:
English: faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate)
Danish: hurtig vejrtrækning, svedtendens, nedsat bevidsthed og pludselige ændringer i blodtrykket og hjerterytmen)
English: Twist + Pull Off b) Select one of the following hypodermic safety needles depending on the injection site and patient's weight.
Danish: Drej + tag af b) Tag en af de medfølgende hypodermiske sikkerhedskanyler alt efter injektionssted og patientens vægt.
English: - higher amounts of bilirubin in your blood
Danish: - højere niveau af bilirubin i blodet
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, svedtendens,
English: The front chamber between front stopper and middle stopper contains the powder and the rear chamber between middle stopper and end stopper the solvent.
Danish: Det forreste kammer mellem frontproppen og mellemproppen indeholder pulveret, og det bagerste kammer mellem mellemproppen og slutproppen indeholder solvensen.
English: *If there's resistance or difficulty expelling air, check that plunger rod is rotated to a complete stop.
Danish: *Hvis du mærker modstand eller har svært ved at presse luften ud, skal du kontrollere, om stemplet er drejet helt i bund.
English: Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
Danish: Fortæl det til lægen, hvis du er gravid, hvis du tror, at du er det, eller hvis du planlægger at blive det.
English: Although there is no information on the effect of haemodialysis in treating an overdose with aripiprazole, haemodialysis is unlikely to be useful in overdose management since aripiprazole is highly bound to plasma proteins.
Danish: Selvom virkningen af hæmodialyse ved overdosering med aripiprazol ikke er undersøgt, er det ikke sandsynligt, at hæmodialyse kan anvendes til behandling af overdosering, da aripiprazol i høj grad bindes til plasmaproteiner.
English: Less than doseproportional increases in aripiprazole and dehydro-aripiprazole concentrations and AUC parameters are observed after monthly Abilify Maintena injections of 300 mg to 400 mg.
Danish: Mindre end dosisproportionale stigninger i aripiprazol- og dehydroaripiprazolkoncentrationen og AUC er observeret efter månedlige injektioner af Abilify Maintena 300 mg til 400 mg.
English: > 4 weeks and < 5 weeks
Danish: > 4 uger og < 5 uger
English: Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalysed by CYP3A4.
Danish: Ifølge in vitro-studier er CYP3A4- og CYP2D6enzymer ansvarlige for dehydrogenering og hydroxylering af aripiprazol, og N-dealkylering katalyseres ved CYP3A4.
English: These included: dose-dependent adrenocortical toxicity in rats after 104 weeks of oral administration at approximately 3 to 10 times the mean steady-state AUC at the maximum recommended human dose and increased adrenocortical carcinomas and combined adrenocortical adenomas/carcinomas in female rats at approximately 10 times the mean steady-state AUC at the maximum recommended human dose.
Danish: Der var tale om følgende virkninger: Dosisafhængig adrenokortikal toksicitet hos rotter efter 104 ugers oral administration ved ca. 3 til 10 gange det gennemsnitlige steady state-AUC ved den maksimale anbefalede humane dosis og øget forekomst af adrenokortikale karcinomer og kombinerede adrenokortikale adenomer/karcinomer hos hunrotter ved ca. 10 gange det gennemsnitlige steady stateAUC ved den maksimale anbefalede humane dosis.
English: • acne, skin condition of the face where the nose and cheeks are unusually red, eczema, skin hardening
Danish: • Akne, en hudlidelse i ansigtet, hvor næsen og kinderne er unormalt røde, eksem, fortykkelse af huden
English: • unable to keep still, difficulty sitting still
Danish: • Motorisk uro, svært ved at sidde stille
English: - higher or lower amounts of blood glucose
Danish: - højere eller lavere niveau af blodsukker
English: • decreased or increased blood levels of the hormone prolactin
Danish: • Nedsat eller forhøjet niveau af hormonet prolaktin i blodet
English: Abilify Maintena with alcohol
Danish: Brug af Abilify Maintena sammen med alkohol
English: By the 7th day, the median aripiprazole concentrations further decline to concentrations following an IM depot dose with no dose dumping.
Danish: Efter 7 dage vil aripiprazolkoncentrationen (medianværdien) være yderligere faldet til en koncentration, der svarer til koncentrationen efter en intramuskulær depotdosis uden dosisdumping.
English: Abilify Maintena also showed statistically significant improvement in symptoms represented by CGIS score change from baseline to week 10.
Danish: Der sås også en statistisk signifikant forbedring af symptomer med Abilify Maintena målt på ændring i CGIS-score fra baseline til uge 10.
English: The second trial was a 52-week, randomised, withdrawal, double-blind, trial conducted in US adult patients with a current diagnosis of schizophrenia.
Danish: Det andet studie var et randomiseret, dobbeltblindet seponeringsstudie over 52 uger med voksne patienter i USA, der havde en aktuel skizofrenidiagnose.
English: • unusual heartbeat, sudden unexplained death, heart attack
Danish: • Unormalt hjerteslag, pludselige uforklarlige dødsfald, hjerteanfald
English: Similarly, for dehydro-aripiprazole the geometric means of Cmax and AUC after carbamazepine co-administration were 69 % and 71 % lower, respectively, than those following treatment with oral aripiprazole alone.
Danish: Tilsvarende var de geometriske middelværdier for dehydroaripiprazols Cmax og AUC efter samtidig administration af carbamazepin henholdsvis 69 % og 71 % lavere, end når oralt aripiprazol blev administreret alene.
English: Abilify Maintena contains less than 1 mmol sodium (23 mg) per dose.
Danish: Abilify Maintena indeholder mindre end 1 mmol natrium (23 mg) pr. dosis.
English: Neuroleptic malignant syndrome Grand mal convulsion Serotonin syndrome Speech disorder
Danish: Malignt neuroleptikasyndrom Grand mal-kramper Serotoninsyndrom Taleforstyrrelser
English: Patients treated with 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, der behandles med aripiprazol, skal observeres for tegn og symptomer på hyperglykæmi (fx polydipsi, polyuri, polyfagi og svækkelse), og patienter med diabetes mellitus eller med risiko for at udvikle diabetes mellitus skal monitoreres regelmæssigt for forværret glucosekontrol (se pkt.
English: However, in one of these trials, a fixed-dose trial, there was a significant doseresponse relationship for cerebrovascular adverse reactions in patients treated with aripiprazole (see section 4.8).
Danish: I et af disse studier, et studie med fast dosis, var der imidlertid et signifikant dosis/respons-forhold, hvad angår cerebrovaskulære bivirkninger hos aripiprazol-behandlede patienter (se pkt.
English: Aripiprazole should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including accelerated or malignant.
Danish: Aripiprazol bør anvendes med forsigtighed til patienter med kendt kardiovaskulær sygdom (myokardieinfarkt eller iskæmisk hjertesygdom i anamnesen, hjertesvigt eller ledningsforstyrrelser), cerebrovaskulær sygdom, tilstande, som disponerer for hypotension (dehydrering, hypovolæmi og behandling med antihypertensiva), eller hypertension, accelereret såvel som malign.
English: Weight gain is commonly seen in schizophrenic patients due to use of antipsychotics known to cause weight gain, co-morbidities, poorly managed life-style and might lead to severe complications.
Danish: Vægtøgning ses ofte hos skizofrene patienter på grund af brug af antipsykotika, der forårsager vægtøgning, komorbiditeter eller en ukontrolleret livsstil, og det kan føre til svære komplikationer.
English: • abnormal heartbeat, slow or fast heart rate, abnormal electrical conduction of the heart,
Danish: • Unormalt hjerteslag, langsom eller hurtig hjerterytme, unormal elektrisk ledning i hjertet,
English: g) Slowly withdraw the recommended volume from the vial into the luer lock syringe to allow for injection.
Danish: g) Træk langsomt den anbefalede mængde suspension fra hætteglasset op i luer lock-sprøjten, der skal bruges til injektion.
English: e) Subsequently, remove the needle from the vial.
Danish: e) Fjern derefter kanylen fra hætteglasset.
English: Patients eligible for the Double-blind, Placebo-controlled Phase were randomly assigned in a 2:1 ratio to double-blind treatment with Abilify Maintena or placebo, respectively.
Danish: Patienter, der var egnede til den dobbeltblindede, placebokontrollerede fase, blev randomiseret i forholdet 2:1 til dobbeltblindet behandling med henholdsvis Abilify Maintena og placebo.
English: These effects gradually resolved with discontinuation of dosing.
Danish: Disse bivirkninger fortog sig gradvist ved seponering.
English: Aripiprazole Long-Acting Injectable 50 mg/25 mg (n = 131)
Danish: Aripiprazol-depotinjektion 50 mg/25 mg (n = 131)
English: The most frequently observed adverse drug reactions (ADRs) reported in ≥ 5 % of patients in two double-blind, long-term trials of Abilify Maintena were weight increased (9.0 %), akathisia (7.9 %), insomnia (5.8 %), and injection site pain (5.1 %).
Danish: De hyppigst observerede bivirkninger, der blev rapporteret hos ≥ 5 % af patienterne i to dobbeltblindede, langvarige studier af Abilify Maintena, var vægtøgning (9,0 %), akatisi (7,9 %), insomni (5,8 %) og smerter på injektionsstedet (5,1 %).
English: If signs and symptoms of tardive dyskinesia appear in a patient on aripiprazole, dose reduction or discontinuation should be considered (see section 4.8).
Danish: Hvis der opstår tegn og symptomer på tardiv dyskinesi hos en patient, der behandles med aripiprazol, skal dosisreduktion eller seponering overvejes (se pkt.
English: If you see more than one doctor, be sure to tell them that you are receiving Abilify Maintena.
Danish: Hvis du tilses af mere end én læge, skal du sige til de pågældende læger, at du får Abilify Maintena.
English: An additional finding was cholelithiasis as a consequence of precipitation of sulphate conjugates of hydroxy-metabolites of aripiprazole in the bile of monkeys after repeated oral dosing at 25 to 125 mg/kg/day or approximately16 to 81 times the maximum recommended human dose based on mg/m2.
Danish: Man fandt også kolelitiasis som følge af udfældning af sulfatkonjugater af hydroxymetabolitter af aripiprazol i galden hos aber efter gentagne orale doser på 25 til 125 mg/kg/dag eller ca. 16 til 81 gange den maksimale anbefalede humane dosis baseret på mg/m2.
English: b Difference (Abilify Maintena minus placebo) in least squares mean change from baseline.
Danish: b Forskellen (Abilify Maintena minus placebo) i middelændring fra baseline beregnet ved mindste kvadraters metode.
English: Step 3: Preparation prior to injection a) Remove the cover, but not the adapter from the package.
Danish: Trin 3: Forberedelser inden injektionen a) Fjern folien, men ikke hætteglasadapteren, fra emballagen.
English: A dose reduction or stopping of the medicinal product should be considered if a patient develops such urges (see section 4.8).
Danish: Det bør overvejes at reducere dosen eller seponere lægemidlet, hvis patienten udvikler en sådan trang (se pkt.
English: Mean baseline (SD) Mean change (SD) P-value
Danish: Middelværdi for ændring (SD) p-værdi
English: For oral aripiprazole, toxicologically significant effects were observed only at doses or exposures that were sufficiently in excess of the maximum human dose or exposure, indicating that these effects were limited or of no relevance to clinical use.
Danish: Hvad angår oralt aripiprazol, så man kun toksikologisk signifikante virkninger ved doser eller eksponeringer, der lå tilstrækkeligt langt over den maksimale humane dosis eller eksponering.
English: You should be given an injection every month but not before the 26 days has passed from the last injection.
Danish: Du skal have en injektion hver måned, idet der skal gå mindst 26 dage mellem hver injektion.
English: Aripiprazole oral doses ranging from 0.5 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: Aripiprazol i orale doser fra 0,5 til 30 mg administreret én gang dagligt til raske forsøgspersoner i 2 uger genererede en dosisafhængig reduktion i bindingen af 11C-racloprid, en D2/D3-receptor-ligand, til nucleus caudatus og putamen påvist ved hjælp af positronemissionstomografi.
English: The potentially medically important signs and symptoms observed included lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea.
Danish: De potentielt medicinsk vigtige tegn og symptomer, der er observeret, omfatter letargi, forhøjet blodtryk, døsighed, takykardi, kvalme, opkastninger og diarré.
English: Abilify Maintena contains sodium
Danish: Abilify Maintena indeholder natrium
English: Powder and solvent for prolonged-release suspension for injection Powder: white to off-white
Danish: Pulver og solvens til depotinjektionsvæske, suspension Pulver: Hvidt til offwhite
English: Keep the syringe in the outer carton in order to protect from light.
Danish: Opbevar den fyldte injektionssprøjte i den ydre karton for at beskytte mod lys.
English: Oral aripiprazole
Danish: Oralt aripiprazol
English: • muscle problems
Danish: • Muskelproblemer
English: A simulation of dose dumping showed that the predicted median aripiprazole concentration reaches a peak of 4,500 ng/ml or approximately 9 times the upper therapeutic range.
Danish: En simuleret dosisdumping har vist, at den forventede maksimale aripiprazolkoncentration (medianværdi) når op på 4.500 ng/ml eller ca. 9 x den øvre grænse for det terapeutiske interval.
English: Although the causes of deaths were varied, most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) or infectious (e.g. pneumonia) in nature (see section 4.8).
Danish: Selv om dødsårsagerne var forskellige, syntes de fleste dødsfald at skyldes cerebrovaskulære hændelser (fx hjertesvigt, pludselig død) eller infektiøse hændelser (fx lungebetændelse) (se pkt.
English: In trials in stable patients with schizophrenia, Abilify Maintena was associated with a higher frequency of EPS symptoms (18.4 %) than oral aripiprazole treatment (11.7 %).
Danish: I studier med stabile skizofrene patienter er Abilify Maintena blevet forbundet med en højere hyppighed af ekstrapyramidale symptomer (18,4 %) end oralt aripiprazol (11,7 %).
English: Thus, superiority of Abilify Maintena over the aripiprazole Long-Acting Injectable 50 mg/25 mg was established and the validity of the trial design was confirmed.
Danish: Abilify Maintenas superioritet i forhold til aripiprazoldepotinjektion 50 mg/25 mg blev således fastslået, og validiteten af studiets design blev bekræftet.
English: The safety and efficacy of Abilify Maintena in the treatment of schizophrenia in patients 65 years of age or older has not been established (see section 4.4).
Danish: Sikkerheden ved og virkningen af Abilify Maintena til behandling af skizofreni hos patienter på 65 år og opefter er ikke klarlagt (se pkt.
English: With intramuscular injection, however an inflammatory response was seen at the injection site, and consisted of granulomatous inflammation, foci (deposited drug), cellular infiltrates, oedema (swelling) and, in monkeys, fibrosis.
Danish: Ved intramuskulær injektion sås imidlertid inflammatorisk respons på injektionsstedet i form af granulomatøs inflammation, foci (aflejret lægemiddel), cellulære infiltrater, ødem (hævelse) og, hos aber, fibrose.
English: • blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
Danish: • blodpropper, blodpropper i familien - antipsykotika er blevet forbundet med blodpropperhar svært ved at synke
English: The estimated proportion of patients experiencing impending relapse by end of Week 26 for Abilify Maintena was 7.12 %, which was statistically significantly lower than in aripiprazole Long-Acting Injectable 50 mg/25 mg (21.80 %; p = 0.0006).
Danish: Den estimerede andel af patienter, der oplevede imminent recidiv ved udgangen af uge 26, var 7,12 % for Abilify Maintena, hvilket statistisk var signifikant lavere end for aripiprazol-depotinjektion 50 mg/25 mg (21,80 %; p = 0,0006).
English: Further, the non-inferiority of Abilify Maintena compared to oral aripiprazole 10-30 mg is supported by the results of the analysis of the Positive and Negative Syndrome Scale score (PANSS).
Danish: Desuden understøttes Abilify Maintenas noninferioritet i forhold til oralt aripiprazol 10-30 mg af PANSS-analyseresultaterne (Positive and Negative Syndrome Scale Score).
English: While overdose is less likely with parenteral than oral medicinal products, reference information for oral aripiprazole overdose is presented below.
Danish: Da overdosering er mindre sandsynlig med parenterale præparater end med orale, er det overdosering med oralt aripiprazol, der omhandles nedenfor.
English: Suicidality
Danish: Suicidal adfærd
English: Anorexia Hyponatraemia
Danish: Anoreksi Hyponatriæmi
English: Add 1.9 ml solvent to reconstitute the powder.
Danish: Tilsæt 1,9 ml solvens for at rekonstituere pulveret.
English: • during blood tests your doctor may find higher amounts of creatine phosphokinase in your blood (enzyme important for muscle function)
Danish: • Lægen kan konstatere en øget mængde kreatinfosfokinase (et enzym, der er vigtigt for muskelfunktionen) i dine blodprøver
English: When compared to studies where Abilify Maintena was injected in the gluteal muscle, repeated occurrence of injection site pain was more frequent in the deltoid muscle.
Danish: Sammenlignet med studier, hvor Abilify Maintena blev injiceret i glutealmusklen, forekom gentagne smerter ved injektionsstedet oftere i deltoidmusklen.
English: When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary adenoma.
Danish: Når vægtøgning ses, er det sædvanligvis hos patienter med signifikante risikofaktorer som fx anamnestisk diabetes, thyroideasygdomme eller hypofyseadenom.
English: • serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,
Danish: • Serotoninsyndrom (en reaktion, hvor der kan opleves stor lykkefølelse, sløvhed, klodsethed,
English: During double-blind treatment, mean change in body weight from baseline to last visit was -0.2 kg for Abilify Maintena and -0.4 kg for placebo (p = 0.812).
Danish: Under den dobbeltblinde behandling var den gennemsnitlige ændring i kropsvægt fra baseline til sidste besøg på −0,2 kg for Abilify Maintena og på −0,4 kg for placebo (p = 0,812).
English: After plunger rod is at complete stop, middle stopper will be at the indicator line.
Danish: Når stemplet ikke kan komme længere ned, vil midterstopperen være ved markeringen.
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Danish: Der er observeret tilfælde af venøs tromboemboli (VTE) i forbindelse med behandling med antipsykotika.
English: Do not store the reconstituted suspension in the syringe.
Danish: Opbevar ikke den rekonstituerede suspension i sprøjten.
English: • jerky resistance to passive movement as muscles tense and relax, abnormally increased muscle tone, slow body movement
Danish: • Rykvis modstand mod passive bevægelser, når musklerne spændes og afslappes, unormalt øget muskelspænding, langsomme kropsbevægelser
English: Following concomitant administration of carbamazepine, a strong inducer of CYP3A4, and oral aripiprazole to patients with schizophrenia or schizoaffective disorder, the geometric means of Cmax and AUC for aripiprazole were 68 % and 73 % lower, respectively, compared to when oral aripiprazole (30 mg) was administered alone.
Danish: Efter samtidig administration af carbamazepin, en potent CYP3A4-induktor, og oralt aripiprazol hos patienter med skizofreni eller skizoaffektive lidelser var de geometriske middelværdier for aripiprazols Cmax og AUC henholdsvis 68 % og 73 % lavere, end når oralt aripiprazol (30 mg) blev administreret alene.
English: Step 2: Reconstitution of the powder a) Remove the solvent and powder vial caps and wipe the tops with a sterile alcohol swab.
Danish: Trin 2: Rekonstitution af pulveret a) Fjern hætten fra hætteglassene med solvens og pulver, og aftør toppen af hætteglassene med en steril spritserviet.
English: In clinical trials and post-marketing experience, accidental or intentional acute overdose of aripiprazole alone was identified in adult patients with reported estimated doses up to 1,260 mg (41 times highest recommended daily aripiprazole dose) with no fatalities.
Danish: I kliniske studier og efter markedsføring er der hos voksne patienter rapporteret om utilsigtet eller intentionel akut overdosering af aripiprazol alene i estimerede doser på op til 1.260 mg (41 x den højeste anbefalede daglige aripiprazoldosis).
English: No dosage adjustment is required for patients with mild or moderate hepatic impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat leverfunktion.
English: Akathisia was the most frequently observed EPS symptom (Abilify Maintena 11.4 % and placebo group 3.5 %).
Danish: Akatisi var det hyppigst observerede ekstrapyramidale symptom (11,4 % for Abilify Maintena-gruppen og 3,5 % for placebogruppen).
English: If it's not possible to advance plunger rod to expel the air, check that plunger rod is rotated to a complete stop.
Danish: Hvis du ikke kan få stemplet til at bevæge sig, så luften kan presses ud, skal du kontrollere, om stemplet er drejet helt i bund.
English: The pivotal trial was a 38 week, randomised, double-blind, active-controlled trial designed to establish the efficacy, safety, and tolerability of this medicinal product administered as monthly injections compared to once daily oral aripiprazole tablets 10-30 mg as maintenance treatment in adult patients with schizophrenia.
Danish: Det pivotale studie var et randomiseret, dobbeltblindet, aktivkontrolleret studie over 38 uger designet til at klarlægge virkningen af og sikkerheden og tolerabiliteten ved dette lægemiddel administreret som månedlige injektioner sammenlignet med oralt aripiprazol 10-30 mg (tabletter) én gang dagligt som vedligeholdelsesbehandling af voksne patienter med skizofreni.
English: When considering concomitant administration of ketoconazole or other potent CYP3A4 inhibitors with aripiprazole, potential benefits should outweigh the potential risks to the patient.
Danish: Hvis samtidig administration af ketoconazol, eller andre potente CYP3A4-hæmmere, og aripiprazol overvejes, skal eventuelle fordele opveje potentielle risici for patienten.
English: Vertically shake the syringe vigorously for 20 seconds until medicine is uniformly milky-white and use immediately.
Danish: Ryst sprøjten kraftigt i lodrette bevægelser i 20 sekunder, indtil indholdet er ensartet mælkehvidt, og brug det med det samme.
English: Sodium Abilify Maintena contains less than 1 mmol of sodium (23 mg) per dose.
Danish: Natrium Abilify Maintena indeholder mindre end 1 mmol natrium (23 mg) pr. dosis.