FrancophonIA/ELRC3.0 huggingface dataset:
English: Somnambulism and related reactions such as sleep talking and sleep related eating disorder
Danish: Søvngængeri og relaterede reaktioner, såsom at tale i søvne og søvnrelaterede spiseforstyrrel ser
English: • You can take your tablets with or without food.
Danish: • Du kan tage tabletterne med eller uden samtidig fødeindtagelse.
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Danish: Passende klinisk monitorering i overensstemmelse med de gældende retningslinjer for antipsykotisk behandling anbefales.
English: Quetiapine is an atypical antipsychotic agent.
Danish: Quetiapin er et atypisk antipsykotisk middel.
English: Hyponatraemia 19, Diabetes Mellitus
Danish: Hyponatriæmi a 19, diabetes mellitus
English: • You have low blood pressure.
Danish: • du har lavt blodtryk.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Danish: Da det ikke er sikkert, at der sker en forbedring i de første få til flere uger af behandlingen, bør patienterne monitoreres tæt indtil bedring.
English: These effects are related to elevated prolactin levels and not directly relevant to humans because of species differences in hormonal control of reproduction.
Danish: Disse virkninger er relateret til forhøjet prolaktinniveauer og ikke direkte relevant for mennesker på grund af artsforskelle i den hormonelle reproduktionskontrol.
English: This is further supported by the data from a positron emission tomography (PET) study, which identified that for quetiapine, 5HT2- and D2-receptor occupancy are maintained for up to 12 hours.
Danish: Dette understøttes yderligere af data fra et positronemissionstomografi (PET)-studie, som for quetiapin, 5HT2 og D2 viste, at besættelsen af receptorer er opretholdt i op til 12 timer.
English: The reduction in total and free T4 was maximal within the first six weeks of quetiapine treatment, with no further reduction during long-term treatment.
Danish: Reduktionen i total og fri T4 var maksimal inden for de første seks uger af quetiapinbehandlingen uden yderligere reduktion under langtidsbehandlingen.
English: Neutropenia 1
Danish: Neutropeni 1
English: Based on very limited data from published reports on quetiapine excretion into human breast milk, excretion of quetiapine at therapeutic doses appears to be inconsistent.
Danish: Baseret på meget begrænsede data fra offentliggjorte rapporter om udskillelse af quetiapin i human mælk er udskillelsen af quetiapin ved brug af terapeutiske doser tilsyneladende inkonsistent.
English: The need to increase the dose from 150 to 300 mg/day should be based on individual patient evaluation.
Danish: Behovet for at øge dosis fra 150 til 300 mg daglig skal baseres på en individuel evaluering.
English: (32) May occur at or near initiation of treatment and be associated with hypotension and/or syncope.
Danish: (32) Kan forekomme ved eller omkring behandlingsstart og kan være forbundet med hypotension og/eller synkope.
English: Efficacy and safety has not been evaluated in patients over 65 years with depressive episodes in the framework of bipolar disorder.
Danish: Sikkerhed og effekt er ikke undersøgt hos patienter over 65 år med depressive episoder inden for bipolar lidelse.
English: • Body temperature decreased (hypothermia).
Danish: • Nedsat kropstemperatur (hypothermi).
English: Seroquel is indicated for: • treatment of Schizophrenia.
Danish: Seroquel Prolong er indiceret til: • behandling af skizofreni .
English: Seroquel XR achieves peak quetiapine and norquetiapine plasma concentrations at approximately 6 hours after administration (Tmax).
Danish: Seroquel Prolong opnår peak quetiapin og norquetiapin plasmakoncentrationer ca. 6 timer efter administration (Tmax).
English: Third trimester
Danish: Tredje trimester
English: • You, or someone in your family, have or have had any heart problems, for example heart rhythm problems, weakening of the heart muscle or inflammation of the heart or if you are taking any medicines that may have an impact on the way your heart beats.
Danish: • du eller nogen i din familie har eller har haft hjerteproblemer, f.eks. problemer med hjerterytmen, svækket hjertemuskel eller betændelse i hjertet, eller hvis du tager medicin, der kan påvirke måden, hvorpå dit hjerte slår.
English: Steady-state peak molar concentrations of the active metabolite norquetiapine are 35% of that observed for quetiapine.
Danish: Steady-state peak molære koncentrationer af den aktive metabolit norquetiapin er 35 % af den, der er set for quetiapin.
English: Elevations in prolactin1
Danish: Stigning i prolaktin1
English: Gradual withdrawal over a period of at least 1 to 2 weeks is advisable.
Danish: Gradvis nedtrapning over en periode på mindst 1 til 2 uger tilrådes.
English: Distribution Quetiapine is approximately 83% bound to plasma proteins.
Danish: Fordeling Quetiapin er ca. 83 % bundet til plasmaproteiner.
English: For the treatment of schizophrenia
Danish: Til behandling af skizofreni
English: These data do not establish a causal relationship between quetiapine treatment and death in elderly patients with dementia.
Danish: Disse data viser ikke en kausal sammenhæng mellem quetiapinbehandling og død hos ældre demenspatienter.
English: • Medicines that can cause constipation.
Danish: • Medicin, der kan medføre forstoppelse.
English: Seroquel can be used to treat several illnesses, such as:
Danish: Seroquel kan bruges til at behandle forskellige sygdomme, som f.eks.:
English: If you notice any of these symptoms seek medical advice immediately.
Danish: Hvis du får nogle af disse symptomer, skal du straks søge læge.
English: Neutropenia should be considered in patients presenting with infection or fever, particularly in the absence of obvious predisposing factor(s), and should be managed as clinically appropriate.
Danish: Neutropeni bør overvejes hos patienter med infektion eller feber, især ved fravær af tydelige prædisponerende faktorer, og bør behandles klinisk hensigtsmæssigt.
English: Severe Neutropenia and agranulocytosis:
Danish: Alvorlig neutropeni og agranulocytose
English: The tablets should be swallowed whole and not split, chewed or crushed.
Danish: Tabletterne skal synkes hele og må ikke deles, tygges eller knuses.
English: Seroquel with food, drink and alcohol
Danish: Brug af Seroquel sammen med mad, drikke og alkohol
English: There have been reports of false positive results in enzyme immunoassays for methadone and tricyclic antidepressants in patients who have taken quetiapine.
Danish: Der er blevet indberettet falsk-positive resultater i forbindelse med enzym-immunanalyser af metadon og tricykliske antidepressiva hos patienter, som har taget quetiapin.
English: (For cataracts/lens opacities see section 5.1).
Danish: (Angående katarakter/linseuklarheder, se pkt 5.1).
English: • A slower than normal heart rate which may occur when starting treatment and which may be associated with low blood pressure and fainting.
Danish: • Nedsat hjerterytme, der kan forekomme ved behandlingsstart og som kan være forbundet med lavt blodtryk og besvimelse.
English: The long-term efficacy of Seroquel IR in prevention of schizophrenic relapses has not been verified in blinded clinical trials.
Danish: Den langsigtede effekt af Seroquel til forebyggelse af recidiv hos skizofrene patienter er ikke blevet kontrolleret i blindede kliniske studier.
English: Quetiapine treatment was associated with dose-related decreases in thyroid hormone levels.
Danish: Behandlingen med quetiapin var forbundet med dosisrelaterede fald i thyroideahormonniveauerne.
English: Tell your doctor if you are taking any of the following medicines:
Danish: Fortæl det til lægen, hvis du tager et af følgende lægemidler:
English: In a specific interaction study in psychotic patients, however, no increase in the cytochrome P450 activity was found after administration of quetiapine.
Danish: I et specifikt interaktionsstudie hos psykotiske patienter sås dog ingen stigning i cytochrom P450 aktiviteten efter administration af quetiapin.
English: Long-term safety
Danish: Sikkerhed på langtidsstudier
English: Mean change among patients who had this increase was 41.7 mg/dL (≥1.07 mmol/L).
Danish: Gennemsnitsændringen blandt patienter med denne stigning var 41,7 mg/dl (≥1,07 mmol/l).
English: Most cases of severe neutropenia have occurred within a couple of months of starting therapy with quetiapine.
Danish: De fleste alvorlige neutropenitilfælde er sket inden for et par måneder efter quetiapin-behandlingen er startet.
English: In clinical trials, no additional benefit was seen in the 600 mg group compared to the 300 mg group (see section 5.1).
Danish: I kliniske studier sås der ingen yderligere fordel i 600 mg gruppen i forhold til 300 mg gruppen (se pkt.
English: There are no data from long-term studies to demonstrate Seroquel's effectiveness in preventing subsequent manic or depressive episodes.
Danish: Der findes ingen data fra langtidsstudier, der viser Seroquels evne til at forebygge senere maniske eller depressive episoder.
English: In addition, a 6-week placebo controlled study for the treatment of schizophrenia (n=222 patients, aged 13-17) was performed.
Danish: Endvidere blev der udført et 6-ugers placebo-kontrolleret studie vedrørende behandling af skizofreni (n=222 patienter i alderen 13-17).
English: • Thoughts of suicide and worsening of your depression.
Danish: Selvmordstanker og forværring af din depression
English: • You have diabetes or have a risk of getting diabetes.
Danish: • du har sukkersyge eller har risiko for at få det.
English: It is also not recommended to consume grapefruit juice while on quetiapine therapy.
Danish: Det anbefales ligeledes ikke at indtage grapefrugtjuice, når man er i behandling med quetiapin.
English: Treatment with quetiapine should be reassessed in patients with suspected cardiomyopathy or myocarditis.
Danish: Behandlingen med quetiapin skal revurderes hos patienter med mistænkt kardiomyopati eller myokarditis.
English: • Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Danish: • Blodpropper i venerne specielt i benene (symptomer på dette er hævelse, smerte og rødmen af benet), som gennem blodårerne kan transporteres til lungerne og forårsage smerter i brystet og problemer med at trække vejret.
English: • Vomiting (mainly in the elderly).
Danish: • Opkastning (fortrinsvis hos ældre).
English: • A long-lasting and painful erection (Priapism).
Danish: • en langvarig og smertefuld erektion (priapisme).
English: This could increase the occurrence of accidental injury (fall), especially in the elderly population.
Danish: Det kan øge risikoen for faldulykker, især hos den ældre del af populationen.
English: • A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock.
Danish: • En alvorlig allergisk reaktion (anafylakse), som kan medføre åndedrætsbesvær og shock.
English: (2) Somnolence may occur, usually during the first two weeks of treatment and generally resolves with the continued administration of quetiapine.
Danish: (2) Døsighed kan forekomme - oftest i de første 2 uger af behandlingen og ophører normalt ved fortsat administration af quetiapin.
English: The AUC and Cmax for the active metabolite, norquetiapine, were higher, approximately 62% and 49% in children (10-12 years), respectively and 28% and 14% in adolescents (13-17 years), respectively, compared to adults.
Danish: AUC og Cmax for den aktive metabolit, norquetiapin, var højere, ca. hhv. 62 % og 49 % hos børn (10-12 år) og hhv. 28 % og 14 % hos unge (13-17 år) sammenlignet med voksne.
English: In laboratory animals at a clinically relevant exposure level the following deviations were seen, which as yet have not been confirmed in long-term clinical research:
Danish: Hos laboratoriedyr sås i klinisk relevante eksponeringsniveauer følgende afvigelser, som indtil videre ikke er bekræftet i længerevarende klinisk forskning.
English: In comparison, a light meal had no significant effect on the Cmax or AUC of quetiapine.
Danish: Til sammenligning havde et let måltid ingen signifikant effekt på quetiapins Cmax eller AUC.
English: There is no specific antidote to quetiapine.
Danish: Der er ingen specifik antidot mod quetiapin.
English: The primary outcome variable in the placebo-controlled trial was change from baseline to final assessment in the PANSS total score.
Danish: Primær effektparameter i det placebo-kontrollerede studiet var ændring i PANSS total fra baseline til endelig evaluering.
English: • Erythromycin or clarithromycin (for infections).
Danish: • Erythromycin eller clarithromycin (mod infektioner).
English: Given the primary central nervous system effects of quetiapine, quetiapine should be used with caution in combination with other centrally acting medicinal products and alcohol.
Danish: Da quetiapin primært virker på centralnervesystemet, bør quetiapin anvendes med forsigtighed, når det kombineres med andre centralt virkende lægemidler og alkohol.
English: Tablet coating: hypromellose, macrogol, titanium dioxide (E171).
Danish: Tabletovertræk: Hypromellose, macrogol, titandioxid (E171).
English: Mild asthenia, peripheral oedema, irritability, pyrexia
Danish: Let asteni, perifert ødem, irritabilitet, pyreksi
English: Quetiapine is active in tests for antipsychotic activity, such as conditioned avoidance.
Danish: Quetiapin er aktiv i tests for antipsykotisk aktivitet såsom i betingede undvigereaktioner (conditioned avoidance).
English: As Seroquel has several indications, the safety profile should be considered with respect to the individual patient's diagnosis and the dose being administered.
Danish: Da Seroquel har flere indikationer, skal der tages højde for sikkerhedsprofilen under hensyntagen til den enkelte patients diagnose og den administrerede dosis.
English: It is this combination of receptor antagonism with a higher selectivity for 5HT2 relative to D2- receptors, which is believed to contribute to the clinical antipsychotic properties and low extrapyramidal side effect (EPS) liability of Seroquel compared to typical antispychotics.
Danish: Det er denne kombination af receptorantagonisme med en højere selektivitet til 5HT2-receptorer i forhold til D2-receptorer, som menes at medvirke til de kliniske antipsykotiske egenskaber og den lave tilbøjelighed til at udløse ekstrapyramidale bivirkninger (EPS) for Seroquel sammenlignet med typiske antipsykotika.
English: The efficacy and safety of Seroquel was studied in a 3-week placebo controlled study for the treatment of mania (n= 284 patients from the US, aged 10-17).
Danish: Seroquels effekt og sikkerhed blev undersøgt i et 3-ugers placebo-kontrolleret studie vedrørende behandling af mani (n=284 patienter fra USA i alderen 10-17).
English: It is important that any change in the inducer is gradual, and if required, replaced with a non-inducer (e.g. sodium valproate).
Danish: Det er vigtigt, at enhver ændring af behandlingen med induceren sker gradvist og hvis nødvendigt, at erstatte denne med en non-inducer (f.eks. natriumvalproat).
English: In addition, physicians should consider the potential risk of suicide-related events after abrupt cessation of quetiapine treatment, due to the known risk factors for the disease being treated.
Danish: Desuden bør læger overveje den potentielle risiko for selvmordsrelaterede hændelser efter pludseligt ophør af behandling med quetiapin, som følge af de kendte risikofaktorer for den behandlede sygdom.
English: Clinical trials have demonstrated that Seroquel is effective in schizophrenia and mania when given twice a day, although quetiapine has a pharmacokinetic half-life of approximately 7 hours.
Danish: Kliniske studier har vist effekt af Seroquel ved skizofreni og mani ved administration to gange dagligt, selvom quetiapin har en halveringstid på ca. 7 timer.
English: Dose adjustments may be necessary in these patients (see section 4.2).
Danish: Det kan være nødvendigt med dosisjustering i denne patientgruppe (se pkt.
English: Constipation and intestinal obstruction
Danish: Forstoppelse og intestinal obstruktion
English: Cardiomyopathy and Myocarditis
Danish: Kardiomyopati og myokarditis
English: Toxic Epidermal Necrolysis, Erythema Multiforme
Danish: Toksisk epidermal nekrolyse, erythema multiforme
English: For about 2/3 of all cases, cessation of quetiapine treatment was associated with a reversal of the effects on total and free T4, irrespective of the duration of treatment.
Danish: I 2 ud 3 af alle tilfælde var ophør med quetiapinbehandlingen forbundet med en reversering af virkningen på det totale og frie T4, uanset behandlingens varighed.
English: • Seroquel XR does not require any special storage conditions.
Danish: • Seroquel Prolong kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: In such an event, quetiapine should be discontinued and appropriate medical treatment given.
Danish: I sådanne tilfælde bør behandlingen med quetiapin ophøre og passende medicinsk behandling påbegyndes.
English: • You are an elderly person with dementia (loss of brain function).
Danish: • du er en ældre dement person (nedsat hjernefunktionsevne).
English: This effect occurred in the presence of overt maternal effects such as reduced body weight gain.
Danish: Denne virkning forekom i tilfælde af tydelige maternelle påvirkninger, som f.eks. reduceret vægtøgning.
English: (31) See Section 4.6.
Danish: (31) Se pkt 4.6.
English: The incidences of ADRs associated with quetiapine therapy, are tabulated below (Table 1) according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group; 1995).
Danish: Forekomsten af bivirkninger i forbindelse med quetiapin-behandling er gengivet nedenfor (tabel 1) i tabelformat som anbefalet af Council for International Organizations of Medical Sciences (CIOMS III Working Group; 1995).
English: Seroquel XR 400 mg/day, 600 mg/day and 800 mg/day were associated with statistically significant improvements in psychotic symptoms compared to placebo.
Danish: Seroquel Prolong 400 mg/dag, 600 mg/dag og 800 mg/dag var alle forbundet med statistisk signifikante forbedringer i psykotiske symptomer sammenlignet med placebo.
English: Whilst the prevention of absorption in overdose has not been investigated, gastric lavage can be indicated in severe poisonings and if possible to perform within one hour of ingestion.
Danish: Selvom hæmning af absorption ved overdosis ikke er undersøgt, kan maveudskylning være indiceret ved alvorlig forgiftning og bør så vidt muligt udføres inden for en time efter indtagelsen.
English: Pancreatitis has been reported in clinical trials and during post marketing experience.
Danish: Pancreatitis er blevet rapporteret ved kliniske studier og efter markedsføring.
English: Given its primary central nervous system effects, quetiapine may interfere with activities requiring mental alertness.
Danish: Da effekten primært ses i centralnervesystemet, kan quetiapin påvirke aktiviteter, der nødvendiggør mental bevågenhed.
English: Longer term relapse prevention trials had an open label period (ranging from 4 to 36 weeks) during which patients were treated with quetiapine, followed by a randomized withdrawal period during which patients were randomized to quetiapine or placebo.
Danish: Recidivforebyggende langtidsstudier havde en open label-periode (fra 4 til 36 uger), hvor patienterne blev behandlet med quetiapin, efterfulgt af en randomiseret afvænningsperiode, hvor patienterne blev randomiseret til quetiapin eller placebo.
English: From animal studies it appears that quetiapine can induce cytochrome P450 enzymes.
Danish: Fra dyrestudier forekommer det, at quetiapin kan inducere cytochrom P450 enzymer.
English: Constipation along with persistent abdominal pain, or constipation which has not responded to treatment, as this may lead to a more serious blockage of the bowel.
Danish: Forstoppelse sammen med vedholdende mavesmerter, eller forstoppelse, som ikke har reageret på behandling, da dette kan medføre en mere alvorlig blokering af tarmene.
English: (19) Shift from >132 mmol/L to ≤132 mmol/L on at least one occasion.
Danish: (19) Skift fra >132 mmol/l til ≤132 mmol/l ved mindst ét tilfælde.
English: • Severe rash, blisters, or red patches on the skin.
Danish: • Alvorligt udslæt, blærer eller røde pletter på huden.
English: • Do not use Seroquel after the expiry date which is stated on the container after EXP.
Danish: • Brug ikke Seroquel Prolong efter den udløbsdato, der står på pakningen efter EXP.
English: Elderly patients with dementia-related psychosis Quetiapine is not approved for the treatment of dementia-related psychosis.
Danish: Ældre patienter med demensrelateret psykose Quetiapin er ikke godkendt til behandling af demensrelateret psykose.
English: You should not take Seroquel during pregnancy unless this has been discussed with your doctor.
Danish: Du bør ikke tage Seroquel under graviditet, medmindre du har aftalt det med din læge.
English: Confirmation of questionable immunoassay screening results by an appropriate chromatographic technique is recommended.
Danish: Det anbefales, at man screener tvivlsomme immunanalyse-resultater med en passende kromatografisk metode.
English: Based on shifts above clinically significant thresholds (adapted from the National Institutes of Health criteria) or increases >20 mmHg for systolic or >10 mmHg for diastolic blood pressure at any time in two acute (3-6 weeks) placebo-controlled trials in children and adolescents.
Danish: Baseret på ændringer over klinisk signifikante tærskler (tilpasset fra National Institutes of Healths kriterier) eller stigninger på >20 mmHg for systolisk eller >10 mmHg for diastolisk blodtryk ved ethvert tidspunkt i to akutte (3-6 uger) placebo-kontrollerede studier med børn og unge.
English: Clinicians should therefore ensure that the lowest effective dose, starting with 50 mg/day, is used for treatment.
Danish: Klinikerne bør derfor sikre sig, at den laveste effektive dosis, startende med 50 mg/dag, anvendes i behandlingen.
English: From Day 4 onwards, the dose should be titrated to the usual effective dose of 300 to 450 mg/day.
Danish: Fra dag 4 og frem skal dosis titreres til det normale effektive doseringsniveau mellem 300 - 450 mg/dag.
English: Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day.
Danish: Yderligere dosisjusteringer op til 800 mg/dag på dag 6 bør ske trinvist med maksimalt 200 mg/dag.
English: The pharmacokinetics of quetiapine and norquetiapine are linear and dose-proportional for doses up to 800 mg administered once daily.
Danish: Farmakokinetikken af quetiapin og norquetiapin er lineær og proportional med dosis for doser op til 800 mg administreret en gang daglig.
English: • Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
Danish: • Mani: Du kan føle dig meget opstemt, opløftet, ophidset, begejstret eller hyperaktiv eller have en dårlig dømmekraft, som omfatter aggressiv eller destruktiv opførsel.
English: • Changes in the amount of certain fats (triglycerides and total cholesterol)
Danish: • Ændring i indholdet af visse typer fedt (triglycerider og totalkolesterol) i blodet.
English: In open label trials, in patients with schizophrenia, quetiapine was effective in maintaining the clinical improvement during continuation therapy in patients who showed an initial treatment response, suggesting some long-term efficacy.
Danish: I open-label-studier med skizofrene patienter var quetiapin effektiv til opretholdelse af den kliniske forbedring under kontinuerlig behandling af patienter, som indledningsvist responderede på behandlingen, hvilket peger på en langsigtet effekt.
English: • Nefazodone (for depression).
Danish: • Nefazodon (mod depression).
English: 25 mg tablets
Danish: 25 mg tabletter