FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients stabilised on Seroquel immediate release 400 mg to 800 mg, efficacy was maintained when patients were switched to an equivalent daily dose of Seroquel XR given once daily.
Danish: Hos patienter stabiliseret på Seroquel tabletter 400 mg til 800 mg blev effekten fastholdt, når patienterne blev skiftet til en ækvivalent Seroquel Prolong-dosis givet en gang daglig.
English: 6.4 Special precautions for storage This medicinal product does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige opbevaringsforhold.
English: Increases in blood pressure2
Danish: Blodtryksstigning2
English: The same ADRs described above for adults should be considered for children and adolescents.
Danish: De samme bivirkninger, som er beskrevet ovenfor for voksne, bør forventes hos børn og unge.
English: If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of quetiapine should be considered.
Danish: Hvis der udvises tegn og symptomer på tardiv dyskinesi, bør det overvejes, om quetiapin skal reduceres eller behandlingen ophøre.
English: At steady-state, the dose-normalised plasma levels of the parent compound, quetiapine, in children and adolescents (10-17 years of age) were in general similar to adults, though Cmax in children was at the higher end of the range observed in adults.
Danish: Ved steady-state lignede de dosisnormaliserede plasmaniveauer af moderstoffet, quetiapin, hos børn og unge (10-17 år) generelt voksnes, selvom Cmax hos børn var i den højere ende af det område, som blev observeret hos voksne.
English: (5) Calculation of Frequency for these ADR's have only been taken from postmarketing data with the immediate release formulation of quetiapine.
Danish: (5) Udregning af bivirkningsfrekvens stammer udelukkende fra postmarketing-data med quetiapintabletformuleringen.
English: • add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy (see Section 5.1).
Danish: • supplerende behandling af depressive episoder hos patienter med unipolar depression (major depression), der har suboptimalt respons på monoterapi med antidepressiva (se pkt.
English: Side effects in children and adolescents The same side effects that may occur in adults may also occur in children and adolescents.
Danish: Bivirkninger hos børn og unge De samme bivirkninger, der indtræder hos voksne, kan også forekomme hos børn og unge.
English: This includes fatal reports in patients who are at higher risk of intestinal obstruction, including those that are receiving multiple concomitant medications that decrease intestinal motility and/or may not report symptoms of constipation.
Danish: Der er rapporteret om dødelige tilfælde hos patienter med en højere risiko for intestinal obstruktion, herunder patienter i samtidig behandling med flere lægemidler, som nedsætter den intestinale motilitet, og /eller patienter, der ikke rapporterede symptomer på forstoppelse.
English: Do not store above 30°C.
Danish: Må ikke opbevares over 30º C.
English: If you are having a urine drug screen, taking Seroquel may cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TCAs) when some test methods are used, even though you may not be taking methadone or TCAs.
Danish: Hvis du skal havet taget en urinprøve til narkotikatestning, kan behandling med Seroquel kombineret med bestemte testmetoder medføre, at prøven testes positiv for metadon samt nogle stoffer til behandling af depression, som hedder tricykliske antidepressiva (TCA), selvom du hverken tager metadon eller TCA'er.
English: There were no additional safety findings associated with treatment with Seroquel XR for up to 9 months (median 7 months).
Danish: Gennemsnitsdosis var 669 mg. Der er ikke yderligere fund i relation til sikkerhed forbundet med Seroquel Prolong-behandling i op til 9 måneder (median 7 måneder).
English: If you do, your doctor may check your blood sugar levels while you are taking Seroquel.
Danish: Hvis dette er tilfældet, kan det være at din læge checker dit blodsukkerniveau, mens du tager Seroquel.
English: A 26-week open-label extension to the acute trials (n=380 patients), with Seroquel flexibly dosed at 400800 mg/day, provided additional safety data.
Danish: En 26-ugers open-label-forlængelse af de akutte studierne (n=380 patienter) med Seroquel med en fleksibel dosis på 400-800 mg/dag gav yderligere sikkerhedsdata.
English: Seizure 1, Restless legs syndrome, Tardive dyskinesia 1, 5,
Danish: Krampeanfald , restless legs-syndrom, tardiv dyskinesi1,5,
English: The safety results showed a higher incidence of extrapyramidal symptoms reported in 16.8% of patients in the lithium add-on group and 6.6% in the placebo add-on group, the majority of which consisted of tremor, reported in 15.6% of the patients in the lithium add-on group and 4.9% in the placebo add-on group.
Danish: Resultaterne for sikkerhed viste en højere forekomst af ekstrapyramidale symptomer, der blev rapporteret hos 16,8 % af patienterne i gruppen med lithium som tillægsbehandling og hos 6,6 % i gruppen med placebo som tillægsbehandling, hvor størstedelen bestod af tremor, som blev rapporteret hos 15,6 % af patienterne i gruppen med lithium som tillægsbehandling og hos 4,9 % af gruppen med placebo som tillægsbehandling.
English: • Feeling weak, fainting (may lead to falls).
Danish: • Følelse af svaghed, besvimelse (kan medføre fald).
English: Pharmacokinetic data were sampled in 9 children aged 10-12 years old and 12 adolescents, who were on steady-state treatment with 400 mg quetiapine (Seroquel) twice daily.
Danish: Farmakokinetiske data blev undersøgt hos 9 børn i alderen 10-12 år og 12 unge, som var på steadystate-behandling med 400 mg quetiapin (Seroquel) to gange daglig.
English: The bioavailability of quetiapine is not significantly affected by administration with food.
Danish: Biotilgængeligheden af quetiapin påvirkes ikke signifikant af samtidig fødeindtagelse.
English: The recommended daily dose is 600 mg, however if clinically justified the dose may be increased to 800 mg daily.
Danish: Den anbefalede daglige dosis er 600 mg, dosis kan dog øges til 800 mg daglig, hvis det er klinisk begrundet.
English: Pancreatitis Intestinal obstruction/Ileus
Danish: Pancreatitis intestinal obstruktion/ile us
English: Agranulocytosis26
Danish: Agranulocytos e26
English: Do not take Seroquel if you are taking any of the following medicines:
Danish: Du må ikke tage Seroquel, hvis du tager et af følgende lægemidler:
English: Overdose could lead to QT-prolongation, seizures, status epilepticus, rhabdomyolysis, respiratory depression, urinary retention, confusion, delirium and/or agitation, coma and death.
Danish: Overdosering kan medføre QT-forlængelse, krampeanfald, status epilepticus, rhabdomyolyse, åndedrætsdepression, urinretention, konfusion, delirium og/eller agitation, koma og død.
English: Metabolism and nutritional disorders
Danish: Metabolisme og ernæring
English: QT Prolongation
Danish: QT-forlængelse
English: Patients with a history of suicide related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Danish: Patienter med selvmordsrelaterede hændelser i anamnesen og patienter med hyppige selvmordstanker inden behandlingsstart har en højere risiko for suicidale tanker eller selvmordsforsøg, og disse patienter skal derfor monitoreres grundigt, under behandlingen.
English: Angioedema StevensJohnson syndrome5
Danish: Angioødem StevensJohnsons syndrom5
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with quetiapine and preventive measures undertaken.
Danish: Patienter behandlet med antipsykotiske lægemidler udviser ofte risikofaktorer for VTE, derfor skal alle risikofaktorer for VTE identificeres før og under behandling med Quetiapin og forebyggende foranstaltninger skal foretages.
English: Frequency based on adverse event reports of bradycardia and related events in all clinical trials with quetiapine.
Danish: Hyppigheden er baseret på bivirkningsrapporter om bradykardi og relaterede hændelser i alle kliniske studier med quetiapin.
English: The same side effects that may occur in adults may also occur in children and adolescents.
Danish: De samme bivirkninger, der indtræder hos voksne, kan også forekomme hos børn og unge.
English: Jaundice Hepatitis
Danish: Gulsot hepatitis
English: The efficacy of Seroquel XR in the treatment of schizophrenia was demonstrated in one 6-week placebocontrolled trial in patients who met DSM-IV criteria for schizophrenia, and one active-controlled Seroquel immediate release-to-Seroquel XR switching study in clinically stable outpatients with schizophrenia.
Danish: Effekten af Seroquel Prolong til behandling af skizofreni blev vist i ét 6-ugers placebo-kontrolleret studie med patienter, som opfyldte DSM-IV-kriteriet for skizofreni og i ét aktivt kontrolleret studie med skift fra Seroquel tabletter til Seroquel Prolong hos stabile ikke-hospitaliserede patienter med skizofreni.
English: Liver problems If you have liver problems your doctor may change your dose.
Danish: Leverproblemer Din læge vil muligvis ændre din dosis, hvis du har problemer med leveren.
English: • Serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
Danish: • Pludselig alvorlig allergisk reaktion med symptomer såsom feber, blærer på huden og hudafskalning (toksisk epidermal nekrolyse).
English: 6.6 Special precautions for disposal No special requirements.
Danish: 6.6 Regler for destruktion og anden håndtering Ingen særlige forholdsregler.
English: In a monotherapy relapse prevention study, patients with depressive episodes stabilised on open-label Seroquel XR treatment for at least 12 weeks were randomised to either Seroquel XR once daily or placebo for up to 52 weeks.
Danish: Ved et recidivforebyggende monoterapistudie blev patienter med depressive episoder, som havde været stabile på en open-label Seroquel Prolong-behandling i mindst 12 uger, randomiseret til enten Seroquel Prolong én gang om dagen eller placebo i op til 52 uger.
English: In controlled clinical trials there was no difference in the incidence of seizures in patients treated with quetiapine or placebo.
Danish: I kontrollerede kliniske studier sås ingen forskel i hyppigheden af krampeanfald hos patienter behandlet med quetiapin eller placebo.
English: • Feeling irritated.
Danish: • Følelse af irritation.
English: In both bipolar depression and MDD, the incidence of the individual adverse events (eg, akathisia, extrapyramidal disorder, tremor, dyskinesia, dystonia, restlessness, muscle contractions involuntary, psychomotor hyperactivity and muscle rigidity) did not exceed 4% in any treatment group.
Danish: Ved såvel bipolar depression som ved unipolar depression var forekomsten af de enkelte bivirkninger (f.eks. akatisi, ekstrapyramidale symptomer, tremor, dyskinesi, dystoni, rastløshed, ufrivillige muskelsammentrækninger, psykomotorisk hyperaktivitet og muskelstivhed) ikke over 4 % i nogen af behandlingsgrupperne.
English: In a long-term study in stable schizophrenic patients who had been maintained on Seroquel XR for 16 weeks, Seroquel XR was more effective than placebo in preventing relapse.
Danish: I et langtidsstudie med stabiliserede skizofrenipatienter fastholdt på Seroquel Prolong i 16 uger, var Seroquel Prolong mere effektiv end placebo i forebyggelse af tilbagefald.
English: Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine (see section 4.8).
Danish: Malignt neuroleptikasyndrom er blevet sat i forbindelse med antipsykotisk behandling, inklusiv quetiapin (se pkt 4.8).
English: Your doctor may continue to prescribe Seroquel even when you are feeling better.
Danish: Din læge vil muligvis fortsat ordinere Seroquel, selvom du får det bedre.
English: 120 film-coated tablets (150 mg and 300 mg tablets only) 180 film-coated tablets (150 mg and 300 mg tablets only) 240 film-coated tablets (150 mg and 300 mg tablets only)
Danish: 120 filmovertrukne tabletter (kun 150 mg og 300 mg tabletter) 180 filmovertrukne tabletter (kun 150 mg og 300 mg tabletter) 240 filmovertrukne tabletter (kun 150 mg og 300 mg tabletter)
English: In the continuation phase in two of these studies, it was demonstrated that long-term treatment, of patients who responded on Seroquel IR 300 or 600 mg, was efficacious compared to placebo treatment with respect to depressive symptoms, but not with regard to manic symptoms.
Danish: I opfølgningsfasen i to af disse kliniske studier blev det vist, at langtidsbehandling af patienter, som responderede på Seroquel 300 eller 600 mg, var effektfuld sammenlignet med placebobehandling med hensyn til depressive symptomer, men ikke hvad angår maniske symptomer.
English: In the schizophrenia study, the difference in LS mean change from baseline in PANSS total score (active minus placebo) was -8.16 for Seroquel 400 mg/day and -9.29 for Seroquel 800 mg/day.
Danish: I skizofrenistudiet var forskellen i LS-gennemsnitsændring fra baseline i PANSS totalscore (aktiv minus placebo) -8,16 for Seroquel 400 mg/dag og -9,29 for Seroquel 800 mg/dag.
English: Read the package leaflet before use.
Danish: Læs indlægssedlen inden brug Oral anvendelse
English: In pre-clinical tests predictive of EPS, quetiapine is unlike typical antipsychotics and has an atypical profile.
Danish: I prækliniske tests, hvor der undersøges for EPS-tilbøjeligheden, adskiller quetiapin sig fra de typiske antipsykotika og har en atypisk profil.
English: • Swelling of breasts and unexpected production of breast milk (galactorrhoea).
Danish: • Øget brystudvikling og uventet produktion af brystmælk (galaktoré).
English: In vitro CYP inhibition is observed only at concentrations approximately 5 to 50 fold higher than those observed at a dose range of 300 to 800 mg/day in humans.
Danish: In vitro CYP inhibering ses kun ved koncentrationer ca. 5-50 gange højere end de, der ses ved et doseringsinterval hos mennesker på 300800 mg/dag.
English: A retrospective study of children and adolescents who received valproate, quetiapine, or both, found a higher incidence of leucopenia and neutropenia in the combination group versus the monotherapy groups.
Danish: I en retrospektiv studie med børn og unge, som modtog valproat, quetiapin eller begge dele, blev der observeret en højere forekomst af leukopeni og neutropeni i kombinationsgruppen i forhold til i monoterapigrupperne.
English: Effects related to elevated prolactin levels were seen in rats, although these are not directly relevant to humans (see section 5.3 preclinical data).
Danish: Hos rotter blev der set virkninger relateret til forhøjede prolaktinniveauer, men disse er ikke direkte relevante for mennesker (se pkt.
English: Like all medicines, Seroquel can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: You should not take Seroquel XR during pregnancy unless this has been discussed with your doctor.
Danish: Du bør ikke tage Seroquel Prolong under graviditet, medmindre du har aftalt det med din læge.
English: The following symptoms which can represent withdrawal may occur in newborn babies of mothers that have used Seroquel in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Danish: Følgende abstinenssymptomer kan opstå hos nyfødte børn, hvis mødre har taget Seroquel i det sidste trimester (sidste tre måneder af graviditeten): rystelser, muskelstivhed og eller/svaghed, døsighed, ophidselse, åndedrætsbesvær og problemer med at tage føde til sig.
English: • Fainting (may lead to falls)
Danish: • Besvimelse (kan medføre fald).
English: If you stop taking Seroquel
Danish: Hvis du holder op med at tage Seroquel
English: The pharmacokinetics of quetiapine were not significantly altered by co-administration of the antidepressants imipramine (a known CYP 2D6 inhibitor) or fluoxetine (a known CYP 3A4 and CYP 2D6 inhibitor).
Danish: Quetiapins farmakokinetik blev ikke ændret signifikant som følge af samtidig administration af de antidepressive midler imipramin (en kendt CYP2D6-inhibitor) eller fluoxetin (en kendt CYP3A4- og CYP2D6-inhibitor).
English: Patients should be observed for signs and symptoms of infection and neutrophil counts followed (until they exceed 1.5 X 109/L) (see section 5.1).
Danish: Patienterne skal observeres for tegn og symptomer på infektion, og neutrofiltallene skal følges (indtil de overstiger 1,5 x 109/l) (se pkt.
English: • Women to have no monthly period or irregular periods.
Danish: • Kvinder kan få manglende eller uregelmæssig menstruation.
English: 50 mg tablets are peach coloured; 150 mg tablets are white coloured, 200 mg tablets are yellow coloured; 300 mg tablets are pale yellow coloured and 400 mg tablets are white coloured.
Danish: 50 mg tabletter er ferskenfarvede; 150 mg tabletter er hvide; 200 mg tabletter er gule; 300 mg tabletter er lysegule og 400 mg tabletter er hvide.
English: In patients who responded to quetiapine, when comparing continued treatment with quetiapine to switching to lithium, the results indicated that a switch to lithium treatment does not appear to be associated with an increased time to recurrence of a mood event.
Danish: Hvis man sammenligner fortsat behandling med quetiapin med skift til lithium hos patienter, som har responderet på quetiapin, så indikerer resultaterne, at et skift til lithium-behandling ikke ser ud til at være forbundet med en øget tid til en tilbagevendende stemningshændelse.
English: Among post marketing reports, while not all cases were confounded by risk factors, many patients had factors which are known to be associated with pancreatitis such as increased triglycerides (see section 4.4), gallstones, and alcohol consumption.
Danish: Selvom ikke alle tilfældene var påvirket af disse risikofaktorer, havde mange af patienterne blandt de indberettede tilfælde efter markedsføring faktorer, som vides at være forbundet med pancreatitis, herunder forhøjede triglycerider (se pkt.
English: • Combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count, a condition called agranulocytosis.
Danish: • En kombination af feber, influenzalignende symptomer, ondt i halsen eller enhver anden infektion med meget lavt antal hvide blodceller, en tilstand der kaldes agranulocytose.
English: Concomitant use of quetiapine and thioridazine caused an increased clearance of quetiapine with approx. 70%.
Danish: Samtidig indgift af quetiapin og thioridazin medførte forøget clearance af quetiapin på omkring 70 %.
English: The pharmacokinetics of quetiapine and norquetiapine are linear across the approved dosing range.
Danish: Farmakokinetikken af quetiapin og norquetiapin er lineær indenfor det godkendte doseringsinterval.
English: Always take Seroquel exactly as your doctor has told you.
Danish: Tag altid Seroquel nøjagtigt efter lægens anvisning.
English: It is recommended that Seroquel XR is taken once daily without food.
Danish: Det anbefales, at Seroquel Prolong tages en gang daglig uden samtidig fødeindtagelse.
English: Pharmacodynamic effects:
Danish: Farmakodynamisk virkning
English: The mean clearance of quetiapine in the elderly is approximately 30 to 50% lower than that seen in adults aged 18 to 65 years.
Danish: Den gennemsnitlige clearance af quetiapin hos ældre er ca. 30 - 50 % lavere end hos voksne mellem 18 og 65 år.
English: Quetiapine is extensively metabolised by the liver.
Danish: Quetiapin metaboliseres i vid udstrækning i leveren.
English: In the mania study, the difference in LS mean change from baseline in YMRS total score (active minus placebo) was -5.21 for Seroquel 400 mg/day and -6.56 for Seroquel 600 mg/day.
Danish: I manistudiet var forskellen i LS-gennemsnitsændringen fra baseline i YMRS totalscore (aktiv minus placebo) -5,21 for Seroquel 400 mg/dag og -6,56 for Seroquel 600 mg/dag.
English: Extrapyramidal symptoms3, 4
Danish: Ekstrapyramidale symptomer3,4
English: Co-administration of quetiapine and phenytoin (another microsomal enzyme inducer) caused a greatly increased clearance of quetiapine by approx. 450%.
Danish: Samtidig indgift af quetiapin og phenytoin (en anden mikrosomal enzyminducer) medførte en mærkbar stigning i clearance af quetiapin på ca. 450 %.
English: 240 tablets
Danish: 240 tabletter
English: • Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Danish: • Selvom du får det bedre, må du ikke stoppe med at tage tabletterne, uden at have talt med din læge.
English: • Decrease in the amount of red blood cells
Danish: • Nedsat antal røde blodlegemer.
English: No data is available about the incidence of seizures in patients with a history of seizure disorder.
Danish: Der foreligger ingen data om hyppigheden af krampeanfald hos patienter med krampelidelser i anamnesen.
English: Carton (pack) contents Blisters
Danish: Karton (paknings)indhold Blisterkort
English: Dose reduction or more gradual titration should be considered if orthostatic hypotension occurs, especially in patients with underlying cardiovascular disease.
Danish: Hvis der opstår ortostatisk hypotension, bør dosisreduktion eller en mere gradvis titrering overvejes, især hos patienter med underliggende kardiovaskulær sygdom.
English: These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in your blood, increased liver enzymes, decreases in the number of certain types of blood cells, decrease in the amount of red blood cells, increased blood creatine phosphokinase (a substance in the muscles), decrease in the amount of sodium in the blood and increases in the amount of the hormone prolactin in the blood.
Danish: Det kan være ændringer i mængden af visse fedttyper (triglycerider og totalkolesterol) eller sukker i blodet, ændringer i mængden af thyroideahormoner i blodet, forhøjede leverenzymer, fald i mængden af visse typer blodlegemer, fald i antallet af røde blodlegemer, forhøjet blod-kreatinin-fosfokinase (et stof i musklerne), fald i mængden af natrium i blodet og stigninger i mængden af hormonet prolaktin i blodet.
English: The incidence of shifts to >0.5-<1.0 x 109/L was the same (0.2%) in patients treated with quetiapine as with placebo-treated patients.
Danish: Hyppigheden af ændringer til >0,5-<1,0 x 109/l var den samme (0,2 %) hos de patienter, der fik quetiapin, som hos patienter, der fik placebo.
English: Cases of QT prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and torsades de pointes have been reported with the use of neuroleptics and are considered class effects.
Danish: Ved anvendelse af neuroleptika er der rapporteret QT-forlængelse, ventrikulær arytmi, pludselig uforklarlig død, hjertestop og torsades de pointes, disse betragtes som klasseeffekter.
English: For patients who were randomized to placebo, the mean weight gain during the open label period was 2.39 kg, and by week 48 of the randomized period the mean weight gain was 0.89 kg, compared to open label baseline.
Danish: Hos de patienter, der blev randomiseret til placebo, sås en gennemsnitlig vægtøgning på 2,39 kg i open label-perioden, og i uge 48 i den randomiserede periode var vægtøgningen 0,89 kg sammenlignet med open-label baseline.
English: It is important that any change in the inducer is gradual, and if required, replaced with a non-inducer (e.g. sodium valproate) (see section 4.4).
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) (se pkt.