FrancophonIA/ELRC3.0 huggingface dataset:
English: • parkinsonism - medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity),
Danish: • Parkinsonisme - en tilstand med mange forskellige symptomer, der omfatter nedsatte eller langsomme bevægelser, langsom tankegang, spjæt ved bøjning af ben eller arme
English: i) Do not store the reconstituted suspension in the syringe.
Danish: i) Opbevar ikke den rekonstituerede suspension i sprøjten.
English: • triptans (such as sumatriptan and zolmitripitan) used for treating migraine.
Danish: • triptaner (fx sumatriptan og zolmitripitan) til behandling af migræne.
English: Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Danish: Yderligere symptomer kan være forhøjet kreatinkinase, myoglobinuri (rabdomyolyse) og akut nyresvigt.
English: Aripiprazole should be used with caution in patients with a family history of QT prolongation (see section 4.8).
Danish: Aripiprazol skal bruges med forsigtighed til patienter med QT-forlængelse i familieanamnesen (se pkt.
English: In the same trials with oral aripiprazole, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78-88 years).
Danish: Cerebrovaskulære bivirkninger I de samme studier med oralt aripiprazol til ældre patienter blev der rapporteret om cerebrovaskulære bivirkninger (fx slagtilfælde, transitorisk iskæmisk anfald), herunder nogle med dødelig udgang (gennemsnitsalder:84 år; aldersspænd: 78-88 år).
English: and not known (cannot be estimated from the available data).
Danish: < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Due to insufficient safety information in humans and concerns raised by animal reproductive studies, this medicinal product should not be used in pregnancy unless the expected benefit clearly justifies the potential risk to the foetus.
Danish: Patienter, der bliver gravide eller har planer om at blive gravide under behandling med aripiprazol, rådes til at underrette deres læge om det. På grund af utilstrækkelige humane sikkerhedsdata, og fordi reproduktionsforsøg hos dyr har givet anledning til bekymring, bør dette lægemiddel ikke anvendes til gravide, medmindre de forventede fordele for kvinden klart opvejer den potentielle risiko for fostret.
English: Subjects with akathisia typically received anti-cholinergic medicines as treatment, primarily benzatropine mesilate and trihexyphenidyl.
Danish: Patienter med akatisi blev typisk behandlet med antikolinergika, primært benzatropinmesilat og trihexyfenidyl.
English: Urinary retention Urinary incontinence
Danish: Urinretention Urininkontinens
English: The results of analysis of the primary efficacy endpoint, the estimated proportion of patients experiencing impending relapse by end of Week 26 of the Double-blind, Active-controlled Phase, showed that Abilify Maintena 400 mg/300 mg is non-inferior to aripiprazole oral tablets 10-30 mg.
Danish: Resultaterne af analysen af det primære effektmål, den estimerede andel af patienter, der oplevede imminent recidiv ved udgangen af uge 26 i den dobbeltblindede, aktivkontrollerede fase, viste, at Abilify Maintena 400 mg/300 mg er noninferiørt i forhold til oralt aripiprazol 10-30 mg (tabletter).
English: - higher amounts of alanine aminotransferase
Danish: - højere niveau af alaninaminotransferase
English: Add 1.5 ml solvent to reconstitute the powder.
Danish: Tilsæt 1,5 ml solvens for at rekonstituere pulveret.
English: Maintenance treatment of schizophrenia in adults The efficacy of Abilify Maintena in the maintenance treatment of patients with schizophrenia was established in two randomised, double-blind, long-term trials.
Danish: Vedligeholdelsesbehandling af voksne patienter med skizofreni Virkningen af Abilify Maintena som vedligeholdelsesbehandling af patienter med skizofreni er fastlagt i to randomiserede, dobbeltblindede og langvarige studier.
English: Your doctor will make it into a suspension that will be given as an injection.
Danish: Lægen blander sprøjtens indhold til en suspension, som du får injiceret.
English: In a short-term (12-week), randomised, double-blind, placebo-controlled trial with Abilify Maintena 400 mg/300 mg treated subjects the symptoms which had at least twice the incidence of placebo were increased weight and akathisia.
Danish: I et kortvarigt (12 uger), randomiseret, dobbeltblindt placebokontrolleret studie med patienter, der blev behandlet med Abilify Maintena 400 mg/300 mg, var de bivirkninger, der forekom mindst to gange hyppigere end ved placebo, vægtøgning og akatisi.
English: Pull e) Hold syringe upright and advance plunger rod slowly to expel the air.
Danish: Træk e) Hold sprøjten lodret med spidsen i vejret og tryk langsomt på stemplet for at få luften ud.
English: Engage the needle safety device by using the one-handed technique.
Danish: Aktivér sikkerhedsmekanismen ved brug af kun én hånd.
English: After reconstitution each ml of suspension contains 200 mg aripiprazole.
Danish: Efter rekonstitution indeholder hver ml af suspensionen 200 mg aripiprazol.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Danish: Der er rapporteret om agitation, hypertoni, hypotoni, tremor, døsighed, respirationsinsufficiens og dysfagi.
English: Congenital anomalies have been reported; however, causal relationship with aripiprazole could not be established.
Danish: Der er rapporteret om medfødte anomalier, men man har ikke kunnet konstatere nogen kausal sammenhæng mellem disse og aripiprazol.
English: Clear glass pre-filled syringe (type-I glass) with grey chlorobutyl stoppers (front-, middle- and end stopper), polypropylene front assembly, polypropylene finger grip, plunger rod, and silicone over-cap.
Danish: Klar fyldt injektionssprøjte af glas (type 1-glas) med grå chlorobutylprop (front-, mellem- og slutprop), front af polypropylen, fingergreb af polypropylen, stempel og silikonehætte.
English: • hallucination
Danish: • Hallucinationer
English: Prescribers need to be aware of the long-acting properties of Abilify Maintena.
Danish: De ordinerende læger skal være opmærksomme på Abilify Maintenas langtidsvirkninger.
English: If the injection is not performed immediately after reconstitution shake it vigorously for at least 60 seconds to re-suspend prior to injection.
Danish: Hvis der ikke foretages injektion straks efter rekonstitutionen, skal hætteglasset rystes kraftigt i mindst 60 sekunder inden injektionen for at sikre en ensartet suspension.
English: The reconstituted suspension should be used immediately but may be stored below 25°C for up to 4 hours in the vial.
Danish: Den rekonstituerede suspension skal anvendes med det samme, men kan opbevares ved en temperatur under 25 °C i op til 4 timer i hætteglasset.
English: f) Slowly inject into the gluteal or deltoid muscle.
Danish: f) Indgiv langsomt suspensionen i gluteal- eller deltoidmusklen.
English: Nephrolithiasis Glycosuria
Danish: Nefrolitiasis Glukosuri
English: The incidences of the ADRs associated with aripiprazole therapy are tabulated below.
Danish: Incidensen af bivirkninger forbundet med aripiprazol-behandling er opstillet nedenfor.
English: In an open label study comparing bioavailability of Abilify Maintena administered in the deltoid or gluteal muscle, injection site related reactions were slightly more frequent in the deltoid muscle.
Danish: I et åbent studie, der sammenlignede Abilify Maintenas biotilgængelighed ved administration i henholdsvis deltoid- og glutealmusklen, forekom reaktionerne på injektionsstedet en smule hyppigere i deltoidmusklen.
English: Abilify Maintena comes as a white to off-white powder in a clear glass vial.
Danish: Abilify Maintena er et hvidt til off-white pulver, der leveres i et klart hætteglas.
English: Based on population pharmacokinetic evaluation of Abilify Maintena, the total body clearance of aripiprazole was 3.71 L/h in extensive metabolisers of CYP2D6 and approximately 1.88 L/h (approximately 50 % lower) in poor metabolisers of CYP2D6 (for dose recommendation, see section 4.2).
Danish: I en farmakokinetisk populationsanalyse af Abilify Maintena var den totale clearance af aripiprazol 3,71 l/t hos hurtigere CYP2D6-omsættere og ca. 1,88 l/t (ca. 50 % lavere) hos langsomme CYP2D6omsættere (se dosisanbefalinger i pkt.
English: Your doctor will decide on the dose of Abilify Maintena that is right for you.
Danish: Lægen vil beslutte, hvor meget Abilify Maintena du skal have.
English: Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised during treatment with oral aripiprazole.
Danish: Abilify Maintena er beregnet til behandling af voksne patienter med skizofreni, der er tilstrækkeligt stabiliserede ved behandling med aripiprazol i tabletform.
English: Alopecia Acne
Danish: Alopeci Akne
English: Overall, 1.3 % of oral aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of placebo-treated patients in these trials.
Danish: Overordnet blev det i disse studier rapporteret, at 1,3 % af de patienter, der fik oralt aripiprazol, fik cerebrovaskulære bivirkninger, sammenholdt med 0,6 % af de patienter, der fik placebo.
English: Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Danish: Abilify Maintena er indiceret til vedligeholdelsesbehandling af skizofreni hos voksne patienter stabiliseret med oralt aripiprazol.
English: Ensure the needle is firmly seated on the needle protection device with a push and clockwise twist and then pull the needle cap straight away from the needle.
Danish: Tjek, at kanylen sidder godt fast i sikkerhedshylsteret, ved at give hylsteret et lille tryk og dreje det en smule med uret, og træk derefter nålehætten af nålen i en lige bevægelse væk fra nålen.
English: • dry mouth
Danish: • Tør mund
English: This trial consisted of a screening phase and 4 treatment phases: Conversion, Oral Stabilisation, Abilify Maintena Stabilisation, and Double-blind Placebo-controlled.
Danish: Studiet bestod af en screeningsfase og fire behandlingsfaser: En konverteringsfase, en oral stabiliseringsfase, en Abilify Maintenastabiliseringsfase og en dobbeltblindet placebokontrolleret fase.
English: • uncontrollable twitching, jerking or writhing movements
Danish: • Ukontrollerede spjættende, rykvise eller vridende bevægelser
English: In clinical trials, rare cases of NMS were reported during treatment with aripiprazole.
Danish: Der har i kliniske studier været sjældne rapporter om NMS under behandling med aripiprazol.
English: Other strong inhibitors of CYP2D6, such as fluoxetine and paroxetine, may be expected to have similar effects and similar dose reduction should, therefore, be applied (see section 4.2).
Danish: Andre potente CYP2D6-hæmmere som fx fluoxetin og paroxetin kan forventes at have lignende virkninger, og derfor skal dosis reduceres tilsvarende (se pkt.
English: Dose adjustments due to interactions with CYP2D6 and/or CYP3A4 inhibitors and/or CYP3A4 inducers
Danish: Dosisjustering på grund af interaktioner med CYP2D6- og/eller CYP3A4-hæmmere og/eller CYP3A4induktorer
English: - lower amounts of cholesterol in your blood
Danish: - lavere niveau af kolesterol i blodet
English: A small amount of residual solvent will remain in the vial following withdrawal.
Danish: Bagefter vil der stadig være en lille mængde solvens tilbage i hætteglasset.
English: Dosage adjustments should be made in patients taking concomitant strong CYP3A4 inhibitors or strong CYP2D6 inhibitors for more than 14 days.
Danish: Dosis skal justeres hos patienter, der samtidig tager potente CYP3A4-hæmmere eller potente CYP2D6-hæmmere i mere end 14 dage.
English: Contents of the pack and other information What Abilify Maintena contains
Danish: Pakningsstørrelser og yderligere oplysninger Abilify Maintena indeholder:
English: Given the primary CNS effects of aripiprazole, caution should be used when aripiprazole is administered in combination with alcohol or other CNS medicinal products with overlapping adverse reactions such as sedation (see section 4.8).
Danish: Som følge af aripiprazols primære effekt på centralnervesystemet skal der udvises forsigtighed, når aripiprazol administreres sammen med andre CNS-stimulerende lægemidler - eller alkohol - med overlappende bivirkninger som fx sedation (se pkt.
English: strong impulse to gamble excessively despite serious personal or family consequences altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive uncontrollable excessive shopping binge eating (eating large amounts of food in a short time period) or compulsive eating
Danish: • Manglende evne til at modstå trangen eller fristelsen til at udføre en handling, der kan være skadelig for dig selv eller andre, og som kan omfatte: Stærk trang til at spille (sygelig spilletrang) trods alvorlige personlige og familiemæssige konsekvenser Ændret eller øget seksuel interesse og adfærd, der vækker stor bekymring hos dig eller andre, for eksempel en øget seksualdrift Ukontrollerbart overdrevent indkøbsmønster og forbrug Uhæmmet madindtagelse (spise store mængder mad i en kort periode) eller overdreven madindtagelse (spise mere mad end sædvanligt og mere end nødvendigt for at dække sulten) Tilbøjelighed til at vandre omkring Fortæl din læge, hvis du oplever et sådant adfærdsmønster; han/hun vil diskutere måder til at håndtere eller mindske symptomerne.
English: • muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.
Danish: • muskelstivhed, døsighed/søvnighed, langsom vejrtrækning, kvælningsfornemmelse, højt eller lavt blodtryk, unormal hjerterytme.
English: • heart problems including torsades de pointes, stopping of the heart, irregularities in heart rhythm that may be due to abnormal nerve impulses in the heart, abnormal readings during heart examination (ECG) QT prolongation
Danish: • Hjerteproblemer, herunder torsades de pointes, hjertestop, uregelmæssig hjerterytme, der kan skyldes anomale nerveimpulser til hjertet, unormale værdier ved undersøgelse af hjertet (ekg), QT-forlængelse
English: The estimated relapse rate by end of Week 26 was 7.12 % for Abilify Maintena, and 7.76 % for oral aripiprazole tablets 10-30 mg, a difference of -0.64 %.
Danish: Den estimerede recidivrate ved udgangen af uge 26 var 7,12 % for Abilify Maintena og 7,76 % for oralt aripiprazol 10-30 mg (tabletter), svarende til en difference på -0,64 %.
English: Sudden unexplained death Cardiac arrest Torsades de pointes Ventricular arrhythmias QT prolongation
Danish: Torsades de pointes Ventrikulære arytmier QT-forlængelse
English: Therefore, Abilify Maintena is non-inferior to aripiprazole oral tablets 10-30 mg.
Danish: Abilify Maintena er således noninferiørt i forhold til oralt aripiprazol 10-30 mg (tabletformulering).
English: Gait disturbance Chest discomfort Injection site reaction Injection site erythema Injection site swelling Injection site discomfort Injection site pruritus Thirst
Danish: Gangforstyrrelser Gener i brystet Reaktion på injektionsstedet Erytem på injektionsstedet Hævelse på injektionsstedet Ubehag på injektionsstedet Pruritus på injektionsstedet Tørst
English: Aripiprazole absorption into the systemic circulation is slow and prolonged following Abilify Maintena administration due to low solubility of aripiprazole particles.The average absorption half-life of Abilify Maintena is 28 days.
Danish: Absorptionen af aripiprazol i det systemiske kredsløb sker langsomt og forlænges efter administration af Abilify Maintena som følge af aripiprazolpartiklernes lave opløselighed.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Indicator line Plunger Rod b) Vertically shake the syringe vigorously for 20 seconds until the reconstituted suspension appears uniform.
Danish: Markering Stempel b) Ryst sprøjten kraftigt op og ned i 20 sekunder, indtil den rekonstituerede suspension ser ensartet ud.
English: • low sodium level in the blood
Danish: • Lavt niveau af natrium i blodet
English: Muscle rigidity Muscle spasms Muscle twitching Muscle tightness Myalgia
Danish: Muskelrigiditet Muskelspasmer Muskeltrækninger Muskelspændinger Myalgi
English: If you miss an injection of Abilify Maintena
Danish: Hvis du mangler at få en injektion med Abilify Maintena
English: In a clinical trial of oral aripiprazole in healthy subjects, a strong inhibitor of CYP2D6 (quinidine) increased aripiprazole AUC by 107 %, while Cmax was unchanged.
Danish: I et klinisk studie med raske forsøgspersoner, der fik oralt aripiprazol, øgede en potent CYP2D6hæmmer (kinidin) aripiprazols AUC med 107 %, mens Cmax var uændret.
English: Abilify Maintena powder and solvent for prolonged-release suspension for injection The suspension should be injected immediately after reconstitution but can be stored below 25 °C for up to 4 hours in the vial.
Danish: Abilify Maintena pulver og solvens til depotinjektionsvæske, suspension Suspensionen skal injiceres straks efter rekonstitution, men kan opbevares ved en temperatur under 25 °C i op til 4 timer i hætteglasset.
English: The incidence of weight loss of ≥ 7 % from baseline to last visit was 6.4 % for Abilify Maintena and 6.7 % for placebo.
Danish: Incidensen af et vægttab ≥ 7 % fra baseline til sidste besøg var 6,4 % for Abilify Maintena-gruppen og 6,7 % for placebo-gruppen.
English: Patients taking 300 mg of Abilify Maintena
Danish: Patienter, der tager 300 mg Abilify Maintena
English: The efficacy of Abilify Maintena in acutely relapsed adult patients with schizophrenia was established in a short-term (12-week), randomised, double-blind, placebo-controlled trial (n = 339).
Danish: Akut behandling af voksne patienter med skizofreni Virkningen af Abilify Maintena hos voksne patienter med akut tilbagefald af skizofreni er undersøgt i et kortvarigt (12 uger) randomiseret, dobbeltblindt placebokontrolleret studie (n = 339).
English: The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Danish: Samtidig brug af CYP3A4-induktorer og Abilify Maintena skal undgås, da blodets indhold af aripiprazol reduceres og kan nedsættes til under det virksomme niveau.
English: Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection EU/1/13/882/002
Danish: Abilify Maintena 400 mg pulver og solvens til depotinjektionsvæske, suspension EU/1/13/882/002
English: A number of symptoms of dystonia are then listed, including spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue.
Danish: En række symptomer på dystoni anføres dernæst, herunder spasmer i nakkemusklerne, der i nogle tilfælde kan udvikle sig til en sammensnørende fornemmelse i halsen, synkebesvær, vejrtrækningsbesvær og/eller protrusion af tungen.
English: Patients taking 400 mg of Abilify Maintena
Danish: Patienter, der tager 400 mg Abilify Maintena
English: - higher amounts of aspartate aminotransferase
Danish: - højere niveau af aspartataminotransferase
English: Shake the vial vigorously for at least 30 seconds until the suspension appears uniform.
Danish: Ryst hætteglasset kraftigt i mindst 30 sekunder, indtil suspensionen ser ensartet ud.
English: Concomitant oral aripiprazole should be restarted for 14 days with next administered injection and then resume monthly injection schedule.
Danish: Samtidig med den næste injektion skal der administreres oralt aripiprazol i 14 dage, og derefter genoptages den månedlige injektion.
English: Weight gain has been reported post-marketing among patients prescribed oral aripiprazole.
Danish: Vægtøgning er rapporteret efter markedsføring hos patienter behandlet med oralt aripiprazol.
English: Oropharyngeal spasm Laryngospasm Aspiration pneumonia
Danish: Orofaryngeale spasmer Laryngospasmer Aspirationspneumoni
English: Blood glucose increased Blood glucose decreased Glycosylated haemoglobin increased
Danish: Forhøjet blodsukker Lavt blodsukker Forhøjet glykosyleret hæmoglobin
English: Before treatment with Abilify Maintena, tell your doctor if you suffer from
Danish: Inden du bliver behandlet med Abilify Maintena, skal du fortælle lægen, om følgende lidelser og forhold er gældende for dig:
English: Remember to rotate sites of injections between the two gluteal or deltoid muscles.
Danish: Husk at skifte injektionssted, så der veksles mellem de to gluteal- eller deltoidmuskler.
English: - The active substance is aripiprazole.
Danish: - Aktivt stof: aripiprazol
English: What you need to know before you are given Abilify Maintena Do not use Abilify Maintena:
Danish: Det skal du vide om Abilify Maintena Du må ikke få Abilify Maintena:
English: Other strong inhibitors of CYP3A4, such as itraconazole and HIV protease inhibitors may be expected to have similar effects and similar dose reductions should, therefore, be applied (see section 4.2).
Danish: Andre potente CYP3A4-hæmmere som fx itraconazol og HIV-protease-hæmmere kan forventes at have lignende virkninger, og derfor skal dosis reduceres tilsvarende (se pkt.
English: Volume to Inject
Danish: Injektionsvolumen
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection EU/1/13/882/001
Danish: Abilify Maintena 300 mg pulver og solvens til depotinjektionsvæske, suspension EU/1/13/882/001
English: In CYP2D6 poor metabolisers, concomitant use of strong inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolisers (see section 4.2).
Danish: Hos langsomme CYP2D6-omsættere kan samtidig brug af potente CYP3A4-hæmmere medføre højere plasmakoncentrationer af aripiprazol end hos hurtige CYP2D6-omsættere (se pkt.
English: Concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided for more than 14 days because the blood levels of aripiprazole are decreased and may be below the effective levels (see section 4.5).
Danish: Samtidig brug af CYP3A4-induktorer og Abilify Maintena i mere end 14 dage skal undgås, da blodets indhold af aripiprazol reduceres og kan nedsættes til under det virksomme niveau (se pkt.
English: Hyperglycaemia Hypercholesterolaemia Hyperinsulinaemia Hyperlipidaemia Hypertriglyceridaemia Appetite disorder
Danish: Hyperglykæmi Hyperkolesterolæmi Hyperinsulinæmi Hyperlipidæmi Hypertriglyceridæmi Appetitforstyrrelser
English: • involuntary, irregular muscle movements, especially in the face
Danish: • ufrivillige, uregelmæssige muskelbevægelser, især i ansigtetoplever en kombination af feber,
English: For deep intramuscular gluteal or deltoid injection only.
Danish: Kun til dyb intramuskulær injektion i gluteal- eller deltoidmusklen.
English: Blood glucose fluctuation
Danish: Fluktuerende blodsukkerniveau
English: • enlargement of breast in men, breast tenderness, vaginal dryness
Danish: • Brystforstørrelser hos mænd, ømme bryster, tørhed i skeden
English: • severe liver problems.
Danish: • svære problemer med leveren.
English: When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.
Danish: Når svage CYP3A4-hæmmere (fx diltiazem) eller CYP2D6-hæmmere (fx escitalopram) bruges samtidig med dette lægemiddel, kan en lille stigning i plasmakoncentrationen af aripiprazol forventes.
English: • sleep disorder
Danish: • Søvnforstyrrelser
English: Abilify Maintena comes in a pre-filled syringe containing a white to off-white powder in the front chamber and a clear solvent in the rear chamber.
Danish: Abilify Maintena leveres i en fyldt injektionssprøjte, der indeholder et hvidt til råhvidt pulver i forkammeret og en klar solvens i bagkammeret.