natgillin/translations-raw huggingface dataset:
f) Anbring og fasthold hætteglasset med rekonstitueret suspension på en hård bordplade. 
f) Place and hold the vial of the reconstituted suspension on a hard surface.
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). 
The primary endpoint (change in PANSS total score from baseline to week 10) showed superiority of Abilify Maintena (n = 167) over placebo (n = 172).
AUC og Cmax for dehydroaripiprazol, den aktive metabolit, faldt med henholdsvis 32 % og 47 %. 
The AUC and Cmax of dehydroaripiprazole, the active metabolite, decreased by 32 % and 47 %, respectively.
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. 
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.
Tilbøjelighed til at vandre omkring 
a tendency to wander away
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. 
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.
Ryst sprøjten kraftigt i mindst 20 sekunder for at omryste suspensionen inden injektion, hvis sprøjten har ligget klar i mere end 15 minutter. 
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.
Efter en bekræftet eller formodet overdosering af aripiprazol er tæt lægelig observation og overvågning påkrævet, indtil patienten kommer sig. 
Following any confirmed or suspected overdose with aripiprazole, close medical supervision and monitoring should continue until the patient recovers.
• Søvnløshed (insomni) 
• difficulty sleeping (insomnia)
Tal med lægen om, hvordan du bedst kan ernære dit barn, hvis du får Abilify Maintena. 
Talk to your doctor about the best way to feed your baby if you are receiving Abilify Maintena.
b) Tag en af de medfølgende hypodermiske sikkerhedskanyler alt efter injektionssted og patientens vægt og fastgør kanylen på luer lock-sprøjten med injektionssuspensionen. 
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.
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. 
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.
• Utilsigtet inhalering af mad med risiko for lungebetændelse 
• accidental inhalation of food with risk of pneumonia (lung infection)
OPLYSNINGER TIL LÆGER OG SUNDHEDSPERSONALE 
INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS
0,8 ml e) Aftør toppen på hætteglasset med rekonstitueret suspension med en steril spritserviet. 
0.8 ml e) Wipe the top of the vial of the reconstituted suspension with a sterile alcohol swab.
Drej + tag af 
Twist + Pull Off
Hvis du bemærker et af disse symptomer, skal du straks kontakte lægen. 
If you notice any of these symptoms seek medical advice immediately.
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. 
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.
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. 
Similar to the PANSS Total Score, both the PANSS positive and negative subscale scores also showed an improvement (decrease) from baseline over time.
Enkeltpakning 
Single pack
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. 
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.
rastløshed, fornemmelse af at være beruset, feber, svedtendens eller stive muskler) 
clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
• Ufrivillig vandladning (inkontinens) 
• involuntary loss of urine (incontinence)
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. 
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.
• 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. 
• 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.
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)). 
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)).
hurtig vejrtrækning, svedtendens, nedsat bevidsthed og pludselige ændringer i blodtrykket og hjerterytmen) 
faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate)
Drej + tag af b) Tag en af de medfølgende hypodermiske sikkerhedskanyler alt efter injektionssted og patientens vægt. 
Twist + Pull Off b) Select one of the following hypodermic safety needles depending on the injection site and patient's weight.
- højere niveau af bilirubin i blodet 
- higher amounts of bilirubin in your blood
• Akut forvirring, krampeanfald (epilepsi), koma, en kombination af feber, hurtig vejrtrækning, svedtendens, 
• acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
Det forreste kammer mellem frontproppen og mellemproppen indeholder pulveret, og det bagerste kammer mellem mellemproppen og slutproppen indeholder solvensen. 
The front chamber between front stopper and middle stopper contains the powder and the rear chamber between middle stopper and end stopper the solvent.
*Hvis du mærker modstand eller har svært ved at presse luften ud, skal du kontrollere, om stemplet er drejet helt i bund. 
*If there's resistance or difficulty expelling air, check that plunger rod is rotated to a complete stop.
Fortæl det til lægen, hvis du er gravid, hvis du tror, at du er det, eller hvis du planlægger at blive det. 
Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.
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. 
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.
Mindre end dosisproportionale stigninger i aripiprazol- og dehydroaripiprazolkoncentrationen og AUC er observeret efter månedlige injektioner af Abilify Maintena 300 mg til 400 mg. 
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.
> 4 uger og < 5 uger 
> 4 weeks and < 5 weeks
Ifølge in vitro-studier er CYP3A4- og CYP2D6enzymer ansvarlige for dehydrogenering og hydroxylering af aripiprazol, og N-dealkylering katalyseres ved CYP3A4. 
Based on in vitro studies, CYP3A4 and CYP2D6 enzymes are responsible for dehydrogenation and hydroxylation of aripiprazole, and N-dealkylation is catalysed by CYP3A4.
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. 
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.
• Akne, en hudlidelse i ansigtet, hvor næsen og kinderne er unormalt røde, eksem, fortykkelse af huden 
• acne, skin condition of the face where the nose and cheeks are unusually red, eczema, skin hardening
• Motorisk uro, svært ved at sidde stille 
• unable to keep still, difficulty sitting still
- højere eller lavere niveau af blodsukker 
- higher or lower amounts of blood glucose
• Nedsat eller forhøjet niveau af hormonet prolaktin i blodet 
• decreased or increased blood levels of the hormone prolactin
Brug af Abilify Maintena sammen med alkohol 
Abilify Maintena with alcohol
Efter 7 dage vil aripiprazolkoncentrationen (medianværdien) være yderligere faldet til en koncentration, der svarer til koncentrationen efter en intramuskulær depotdosis uden dosisdumping. 
By the 7th day, the median aripiprazole concentrations further decline to concentrations following an IM depot dose with no dose dumping.
Der sås også en statistisk signifikant forbedring af symptomer med Abilify Maintena målt på ændring i CGIS-score fra baseline til uge 10. 
Abilify Maintena also showed statistically significant improvement in symptoms represented by CGIS score change from baseline to week 10.
Det andet studie var et randomiseret, dobbeltblindet seponeringsstudie over 52 uger med voksne patienter i USA, der havde en aktuel skizofrenidiagnose. 
The second trial was a 52-week, randomised, withdrawal, double-blind, trial conducted in US adult patients with a current diagnosis of schizophrenia.
• Unormalt hjerteslag, pludselige uforklarlige dødsfald, hjerteanfald 
• unusual heartbeat, sudden unexplained death, heart attack
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. 
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.
Abilify Maintena indeholder mindre end 1 mmol natrium (23 mg) pr. dosis. 
Abilify Maintena contains less than 1 mmol sodium (23 mg) per dose.
Malignt neuroleptikasyndrom Grand mal-kramper Serotoninsyndrom Taleforstyrrelser 
Neuroleptic malignant syndrome Grand mal convulsion Serotonin syndrome Speech disorder
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. 
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).
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. 
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).
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. 
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.
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. 
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.
• Unormalt hjerteslag, langsom eller hurtig hjerterytme, unormal elektrisk ledning i hjertet, 
• abnormal heartbeat, slow or fast heart rate, abnormal electrical conduction of the heart,
g) Træk langsomt den anbefalede mængde suspension fra hætteglasset op i luer lock-sprøjten, der skal bruges til injektion. 
g) Slowly withdraw the recommended volume from the vial into the luer lock syringe to allow for injection.
e) Fjern derefter kanylen fra hætteglasset. 
e) Subsequently, remove the needle from the vial.
Patienter, der var egnede til den dobbeltblindede, placebokontrollerede fase, blev randomiseret i forholdet 2:1 til dobbeltblindet behandling med henholdsvis Abilify Maintena og placebo. 
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.
Disse bivirkninger fortog sig gradvist ved seponering. 
These effects gradually resolved with discontinuation of dosing.
Aripiprazol-depotinjektion 50 mg/25 mg (n = 131) 
Aripiprazole Long-Acting Injectable 50 mg/25 mg (n = 131)
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 %). 
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 %).
Hvis der opstår tegn og symptomer på tardiv dyskinesi hos en patient, der behandles med aripiprazol, skal dosisreduktion eller seponering overvejes (se pkt. 
If signs and symptoms of tardive dyskinesia appear in a patient on aripiprazole, dose reduction or discontinuation should be considered (see section 4.8).
Hvis du tilses af mere end én læge, skal du sige til de pågældende læger, at du får Abilify Maintena. 
If you see more than one doctor, be sure to tell them that you are receiving Abilify Maintena.
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. 
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.
b Forskellen (Abilify Maintena minus placebo) i middelændring fra baseline beregnet ved mindste kvadraters metode. 
b Difference (Abilify Maintena minus placebo) in least squares mean change from baseline.
Trin 3: Forberedelser inden injektionen a) Fjern folien, men ikke hætteglasadapteren, fra emballagen. 
Step 3: Preparation prior to injection a) Remove the cover, but not the adapter from the package.
Det bør overvejes at reducere dosen eller seponere lægemidlet, hvis patienten udvikler en sådan trang (se pkt. 
A dose reduction or stopping of the medicinal product should be considered if a patient develops such urges (see section 4.8).
Middelværdi for ændring (SD) p-værdi 
Mean baseline (SD) Mean change (SD) P-value
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. 
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.
Du skal have en injektion hver måned, idet der skal gå mindst 26 dage mellem hver injektion. 
You should be given an injection every month but not before the 26 days has passed from the last injection.
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. 
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.
De potentielt medicinsk vigtige tegn og symptomer, der er observeret, omfatter letargi, forhøjet blodtryk, døsighed, takykardi, kvalme, opkastninger og diarré. 
The potentially medically important signs and symptoms observed included lethargy, increased blood pressure, somnolence, tachycardia, nausea, vomiting and diarrhoea.
Abilify Maintena indeholder natrium 
Abilify Maintena contains sodium
Pulver og solvens til depotinjektionsvæske, suspension Pulver: Hvidt til offwhite 
Powder and solvent for prolonged-release suspension for injection Powder: white to off-white
Opbevar den fyldte injektionssprøjte i den ydre karton for at beskytte mod lys. 
Keep the syringe in the outer carton in order to protect from light.
Oralt aripiprazol 
Oral aripiprazole
• Muskelproblemer 
• muscle problems
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. 
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.
Selv om dødsårsagerne var forskellige, syntes de fleste dødsfald at skyldes cerebrovaskulære hændelser (fx hjertesvigt, pludselig død) eller infektiøse hændelser (fx lungebetændelse) (se pkt. 
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).
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 %). 
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 %).
Abilify Maintenas superioritet i forhold til aripiprazoldepotinjektion 50 mg/25 mg blev således fastslået, og validiteten af studiets design blev bekræftet. 
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.
Sikkerheden ved og virkningen af Abilify Maintena til behandling af skizofreni hos patienter på 65 år og opefter er ikke klarlagt (se pkt. 
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).
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. 
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.
• blodpropper, blodpropper i familien - antipsykotika er blevet forbundet med blodpropperhar svært ved at synke 
• blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
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). 
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).
Desuden understøttes Abilify Maintenas noninferioritet i forhold til oralt aripiprazol 10-30 mg af PANSS-analyseresultaterne (Positive and Negative Syndrome Scale Score). 
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).
Da overdosering er mindre sandsynlig med parenterale præparater end med orale, er det overdosering med oralt aripiprazol, der omhandles nedenfor. 
While overdose is less likely with parenteral than oral medicinal products, reference information for oral aripiprazole overdose is presented below.
Suicidal adfærd 
Suicidality
Anoreksi Hyponatriæmi 
Anorexia Hyponatraemia