FrancophonIA/ELRC3.0 huggingface dataset:
English: For the treatment of schizophrenia and moderate to severe manic episodes in bipolar disorder Seroquel XR should be administrated at least one hour before a meal.
Danish: Til behandling af skizofreni og moderate til svære maniske episoder inden for bipolar lidelse Seroquel Prolong bør tages mindst 1 time før et måltid.
English: • Uncontrollable movements, mainly of your face or tongue.
Danish: • ufrivillige bevægelser, specielt i ansigtet eller tungen.
English: If you are pregnant or breast feeding, think you may be pregnant or planning to have a baby ask your doctor for advice before taking Seroquel.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager Seroquel Prolong.
English: Worsening in these parameters should be managed as clinically appropriate (see also section 4.8).
Danish: Forværring af disse parametre skal håndteres i henhold til normal klinisk praksis (se også pkt.
English: (18) Incidence of patients who have a QTc shift from <450 msec to ≥450 msec with a ≥30 msec increase.
Danish: (18) Hyppigheden af patienter med et QTc-skift fra <450 msek.
English: As with other antipsychotics, caution should be exercised when quetiapine is prescribed in patients with cardiovascular disease or family history of QT prolongation.
Danish: Som med ethvert andet antipsykotika skal der udvises forsigtighed, når quetiapin ordineres hos patienter med kardiovaskulær sygdom eller familiær disponering for QT-forlængelse.
English: You may find that you feel depressed, feel guilty, lack energy, lose your appetite or can't sleep.
Danish: • Bipolar depression: Du føler dig ked af det, eller du kan føle dig deprimeret, have skyldfølelse, mangle energi, miste appetitten eller have svært ved at sove.
English: The mean last week median dose of Seroquel in responders was approximately 600 mg/day and approximately 85% of the responders were in the dose range of 400 to 800 mg/day.
Danish: Den gennemsnitlige mediandosis hos responderende patienter sidste uge i behandlingen var cirka 600 mg dagligt, og ca. 85 % af de responderende lå i et dosisinterval mellem 400 og 800 mg/dag.
English: For patients who were randomized to quetiapine, the mean weight gain during the open label period was 2.56 kg, and by week 48 of the randomized period, the mean weight gain was 3.22 kg, compared to open label baseline.
Danish: Hos de patienter, der blev randomiseret til quetiapin, sås en gennemsnitlig vægtøgning på 2,56 kg i open label-perioden, og i uge 48 i den randomiserede periode var den gennemsnitlige vægtøgning 3,22 kg sammenlignet med open-label baseline.
English: Such patients should have a WBC count and an absolute neutrophil count (ANC) performed promptly, especially in the absence of predisposing factors.
Danish: Hos sådanne patienter skal der omgående foretages tælling af hvide blodlegemer og absolut neutrofiltælling, især hvis der ikke er disponerende faktorer.
English: In vitro investigations established that CYP3A4 is the primary enzyme responsible for cytochrome P450 mediated metabolism of quetiapine.
Danish: In vitro-studier påviste, at CYP3A4 er det primære enzym, ansvarligt for cytochrom P450-medieret metabolisme af quetiapin.
English: • Medicines that have an impact on the way your heart beats, for example, drugs that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (water pills) or certain antibiotics (drugs to treat infections).
Danish: • Medicin, der påvirker din hjerterytme (puls), f.eks. lægemidler, som kan forårsage ubalance i elektrolytterne (lave niveauer af kalium eller magnesium i blodet).
English: Day 3 morning evening 25 mg 2x25 mg 100 mg
Danish: Dag 3 morgen aften 25 mg 2x25 mg 100 mg
English: As quetiapine is extensively metabolised by the liver, elevated plasma levels are expected in the population with hepatic impairment.
Danish: Da quetiapin metaboliseres i udstrakt grad i leveren forventes højere plasmaværdier hos individer med nedsat leverfunktion.
English: Concomitant use of quetiapine with a strong hepatic enzyme inducer such as carbamazepine or phenytoin substantially decreases quetiapine plasma concentrations, which could affect the efficacy of quetiapine therapy.
Danish: Samtidig brug af quetiapin og en stærk leverenzyminducer, som f.eks. carbamazepin eller phenytoin, medfører et betydeligt fald i plasmakoncentrationen af quetiapin, hvilket kan påvirke effekten af quetiapin.
English: In a multiple dose trial in patients to assess the pharmacokinetics of quetiapine given before and during treatment with carbamazepine (a known hepatic enzyme inducer), co-administration of carbamazepine significantly increased the clearance of quetiapine.
Danish: I et multidosis-studie i patienter til bestemmelse af quetiapins farmakokinetik når det administreres hhv. før og samtidig med carbamazepin (en kendt leverenzym-inducer), gav samtidig behandling med carbamazepin en signifikant øget quetiapin-clearance.
English: In clinical studies of patients with MDD the incidence of suicide-related events observed in young adult patients (younger than 25 years of age) was 2.1% (3/144) for quetiapine and 1.3% (1/75) for placebo.
Danish: Kliniske studier med patienter med unipolar depression viste, at hyppigheden af selvmordsrelaterede hændelser hos unge voksne patienter (yngre end 25 år) var 2,1 % (3/144) for quetiapin og 1,3 % (1/75) for placebo.
English: Quetiapine and several of its metabolites (including norquetiapine) were found to be weak inhibitors of human cytochrome P450 1A2, 2C9, 2C19, 2D6 and 3A4 activities in vitro.
Danish: norquetiapin) er svage inhibitorer af human cytochrom P450 1A2, 2C9, 2C19, 2D6 og 3A4 aktiviteter in vitro.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Danish: Der er blevet indberettet agitation, hypertoni, hypotoni, tremor, døsighed, åndedrætsbesvær og problemer med at tage føde til sig.
English: The pharmacokinetics of quetiapine were not significantly altered by co-administration of the antipsychotics risperidone or haloperidol.
Danish: Quetiapins farmakokinetik blev ikke ændret signifikant som følge af samtidig administration af de antipsykotiske midler risperidon eller haloperidol.
English: The mean quetiapine plasma clearance decreases with approximately 25% in persons with known hepatic impairment (stable alcoholcirrhosis).
Danish: Quetiapins gennemsnitlige plasmaclearance er reduceret med ca. 25 % hos individer med nedsat leverfunktion (stabil alkoholisk cirrhosis).
English: In clinical trials and use in accordance with the SPC, quetiapine was not associated with a persistent increase in absolute QT intervals.
Danish: Quetiapin blev i kliniske studier og ved anvendelse i henhold til produktresuméet ikke forbundet med vedvarende forlængelse af absolutte QT-intervaller.
English: • Azole medicines (for fungal infections).
Danish: • Lægemidler som indeholder azoler (mod svampeinfektioner).
English: Renal impairment: Dosage adjustment is not necessary in patients with renal impairment.
Danish: Nedsat nyrefunktion Justering af dosis er ikke nødvendigt hos patienter med nedsat nyrefunktion.
English: In this study patients randomised to Seroquel XR received 50 mg/day on Days 1-3, the dose could be increased to 100 mg/day on Day 4, 150 mg/day on Day 8 and up to 300 mg/day depending on clinical response and tolerability.
Danish: I dette studie fik de patienter, der var blevet randomiseret til Seroquel Prolong, 50 mg/dag på dag 1-3, og dosis kunne øges til 100 mg/dag på dag 4, 150 mg/dag på dag 8 og op til 300 mg/dag afhængigt af klinisk respons og tolerabilitet.
English: Patients should be advised to immediately report the appearance of signs/symptoms consistent with agranulocytosis or infection (e.g., fever, weakness, lethargy, or sore throat) at any time during Seroquel therapy.
Danish: Patienter skal informeres om omgående at indberette tegn/symptomer på agranulocytose eller infektion (f.eks. feber, svaghed, letargi eller ondt i halsen) på et hvilket som helst tidspunkt under behandlingen med Seroquel.
English: Neither low dose (400 mg/day) nor high dose regimen (800 mg/day) quetiapine was superior to placebo with respect to the percentage of patients achieving response, defined as ≥30% reduction from baseline in PANSS total score.
Danish: I hverken lavdosis(400 mg/dag) eller højdosis-regimet (800 mg/dag) var quetiapin bedre end placebo med hensyn til procentdelen af patienter, der fik respons, defineret som ≥30 % reduktion fra baseline i PANSS
English: Elevations in blood creatine phosphokinase14
Danish: Stigning i blodkreatinfos fokinase14
English: • Swelling of arms or legs.
Danish: • Væskeansamlinger i arme og ben.
English: An increase in LDL cholesterol of ≥30 mg/dL (≥0.769 mmol/L) has been very commonly observed.
Danish: Det er meget almindeligt, at der ses en stigning i LDL-kolesterol på ≥30 mg/dl (≥0,769 mmol/l).
English: Neonates exposed to antipsychotics (including quetiapine) 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.
Danish: Nyfødte, der er blevet udsat for antipsykotika (herunder quetiapin) i løbet af graviditetens tredje trimester, har risiko for bivirkninger, herunder ekstrapyramidale symptomer og/eller abstinenser af varierende sværhedsgrad og varighed efter fødslen.
English: Increases in blood pressure were reported in children and adolescents and increased appetite, extrapyramidal symptoms and elevations in serum prolactin were reported with higher frequency in children and adolescents than in adult patients (see sections 4.4 and 4.8).
Danish: Der blev rapporteret blodtryksstigninger hos børn og unge, og øget appetit, ekstrapyramidale symptomer og forhøjet serumprolaktin blev rapporteret med større hyppighed hos børn og unge end hos voksne patienter (se pkt.
English: Hypersensitivity to the active substance or to any of the excipients of this product.
Danish: Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne.
English: The mean dose of Seroquel XR was 160 mg/day.
Danish: Gennemsnitsdosis for Seroquel Prolong var 160 mg/dag.
English: Based on clinical trial adverse event reports of blood creatine phosphokinase increase not associated with neuroleptic malignant syndrome 15.
Danish: (14) Er baseret på bivirkningsrapporter fra kliniske studier vedrørende forhøjet blodkreatinphosphokinase, som ikke var relateret til malignt neuroleptikasyndrom.
English: Quetiapine treatment has been associated with somnolence and related symptoms, such as sedation (see Section 4.8).
Danish: Quetiapinbehandling er blevet forbundet med døsighed og relaterede symptomer som f.eks. sedation (se pkt.
English: (3) Asymptomatic elevations (shift from normal to > 3X ULN at any time) in serum transaminase (ALT, AST) or gamma-GT-levels have been observed in some patients administered quetiapine.
Danish: (3) Asymptomatiske stigninger (ændringer fra normal til > 3X ULN når som helst) i serumtransaminaser (ALAT, ASAT) eller gamma-GT-niveauer er observeret hos nogle patienter i quetiapinbehandling.
English: Elevations in blood creatine phosphokinase
Danish: Stigning i blodkreatinfos fokinase
English: • If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Seroquel (see section 6: Further information)
Danish: • hvis du er allergisk over for quetiapin eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: • Increased levels of sugar in the blood.
Danish: • Øget blodsukkerniveau.
English: In short-term, placebo-controlled clinical trials in schizophrenia and bipolar mania the aggregated incidence of extrapyramidal symptoms was similar to placebo (schizophrenia: 7.8% for quetiapine and 8.0% for placebo; bipolar mania: 11.2% for quetiapine and 11.4% for placebo).
Danish: I placebokontrollerede, kliniske korttidsstudier med skizofreni og bipolær mani svarede den samlede hyppighed af ekstrapyramidale symptomer til hyppigheden ved placebo (skizofreni: 7,8 % for quetiapin og 8,0 % for placebo; bipolær mani: 11,2 % for quetiapin og 11,4 % for placebo).
English: Very Rare Not known
Danish: Ikke kendt
English: Keep the Seroquel tablets with you.
Danish: Tag Seroquel Prolong tabletterne med dig.
English: • Skin rash with irregular red spots (erythema multiforme).
Danish: • Uregelmæssigt hududslæt med røde prikker (erythema multiforme).
English: Responder rates (YMRS improvement ≥50%) were 64% for Seroquel 400 mg/day, 58% for 600 mg/day and 37% in the placebo arm.
Danish: Responsrater (YMRS forbedring ≥50 %) var 64 % for Seroquel 400 mg/dag, 58 % for 600 mg/dag og 37 % i placebogruppen.
English: In elderly patients with major depressive episodes in MDD, dosing should begin with 50 mg/day on Days 1-3, increasing to 100 mg/day on Day 4 and 150 mg/day on Day 8.
Danish: Hos ældre med depressive episoder i forbindelse med unipolar depression skal der indledes med en dosis på 50 mg/dag på dag 1-3, hvorefter dosis øges til 100 mg/dag på dag 4 og til 150 mg/dag på dag 8.
English: In an interaction study in healthy volunteers, concomitant administration of quetiapine (dosage of 25 mg) with ketoconazole, a CYP3A4 inhibitor, caused a 5-to 8-fold increase in the AUC of quetiapine.
Danish: I et interaktionsstudie hos raske forsøgspersoner medførte samtidig administrering af quetiapin (25 mg) og ketoconazol (CYP3A4-inhibitor) en faktor 5 til 8 stigning i quetiapins AUC.
English: Effect on Urine Drug Screens
Danish: Indvirkning på narkotikatestning af urin
English: The percentage of quetiapine treated patients who gained ≥7% of body weight ranged from 5.3% for the 50 mg daily dose to 15.5% for the 400 mg daily dose (with lower gain for the 600 and 800 mg daily doses), compared to 3.7% for placebo treated patients.
Danish: Procenten af quetiapinbehandlede patienter, hvis vægt steg med ≥7 % af legemsvægten varierede fra 5,3 % ved 50 mg/dag til 15,5 % ved 400 mg/dag (hvor den laveste vægtøgning forekom ved daglige doser på 600 og 800 mg) sammenlignet med 3,7 % af de placebobehandlede patienter.
English: Other medicines and Seroquel Tell your doctor if you are taking or have recently taken any other medicines .
Danish: Brug af anden medicin sammen med Seroquel Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: The rates of suicide related events in the active arm vs. placebo were 1.4% vs. 1.3% in the schizophrenia trial, 1.0% vs. 0% in the bipolar mania trial, and 1.1% vs. 0% in the bipolar depression trial.
Danish: Hyppigheden af selvmordsrelaterede hændelser i den aktive arm versus placebo var 1,4 % hhv. 1,3 % i skizofrenistudiet, 1,0 % hhv. 0 % i studiet med bipolar mani, og 1,1 % hhv. 0 % i studiet med bipolar depression.
English: Concomitant administration of cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azoleantifungal agents, erythromycin, clarithromycin and nefazodone, is contraindicated.
Danish: Samtidig administrering af CYP3A4-inhibitorer, såsom hiv-proteaseinhibitorer, svampemidler af azoltypen, erythromycin, clarithromycin og nefazodon er kontraindiceret (se pkt.
English: Weight gain has been seen in patients taking Seroquel.
Danish: Det er observeret vægtøgning hos patienter, der tager Seroquel.
English: • Do not store above 30°C.
Danish: • Må ikke opbevares ved temperaturer over 30oC.
English: In clinical trials for treatment of patients with bipolar depression, onset was usually within the first 3 days of treatment and was predominantly of mild to moderate intensity.
Danish: I kliniske studier på patienter med bipolar depression indtrådte det sædvanligvis inden for de første 3 dages behandling og intensiteten var hovedsagelig mild til moderat.
English: This is because the combined effect of Seroquel and alcohol can make you sleepy.
Danish: Seroquel Prolong og alkohol kan gøre dig søvnig.
English: For maintenance therapy in schizophrenia no dosage adjustment is necessary.
Danish: Justering af dosis er ikke nødvendigt til vedligeholdelsesbehandling af skizofreni.
English: Hyperglycaemia and/ or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma has been reported rarely, including some fatal cases (see section 4.8).
Danish: Der er i sjældne tilfælde blevet rapporteret om hyperglykæmi og/eller udvikling eller forværring af diabetes, sommetider i forbindelse med ketoacidose eller koma, herunder nogle letale tilfælde (se pkt.
English: Day 4 morning evening 25 mg 2x25 mg 100 mg 200 mg
Danish: Dag 4 morgen aften 25 mg 2x25 mg 100 mg 200 mg
English: Seroquel XR 150 mg and 300 mg/day, given as add-on treatment to ongoing antidepressant therapy (amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline or venlafaxine) demonstrated superiority over antidepressant therapy alone in reducing depressive symptoms as measured by improvement in MADRS total score (LS mean change vs. placebo of 2-3.3 points).
Danish: Seroquel Prolong 150 mg og 300 mg daglig, der blev givet som supplerende behandling til den igangværende antidepressivumbehandling (amitriptylin, bupropion, citalopram, duloxetin, escitalopram, fluoxetin, paroxetin, sertralin eller venlafaxin), viste sig at være bedre end behandling med antidepressiva alene til at reducere de depressive symptomer målt ved forbedring af MADRS (Montgomery-Åsberg Depression Rating Scale)-totalscoren (gennemsnitlig ændring vs. placebo på 2-3,3 point).
English: Due to lack of robust data, a decision must be made whether to discontinue breast-feeding or to discontinue Seroquel therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Grundet manglen på robuste data skal det besluttes, om amning eller behandling med Seroquel skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: The most commonly reported Adverse Drug Reactions (ADRs) with quetiapine (≥10%) are somnolence, dizziness, headache, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.
Danish: De hyppigst indrapporterede bivirkninger for quetiapin (≥ 10 %) er døsighed, svimmelhed, hovedpine, mundtørhed, abstinenssymptomer (ved afbrydelse af behandling), forhøjede serumtriglyceridniveauer, forhøjet total-kolesterol (hovedsagelig LDL-kolesterol), fald i HDL-kolesterol, vægtøgning, nedsat hæmoglobin og ekstrapyramidale symptomer.
English: Quetiapine was administered twice-daily totalling 400 mg to 800 mg a day as combination therapy to lithium or valproate.
Danish: Quetiapin blev givet to gange daglig, totalt 400 mg til 800 mg per dag, som kombinationsbehandling med lithium eller valproat.
English: In three placebo-controlled clinical trials, in patients with schizophrenia, using variable doses of quetiapine, there were no differences between the Seroquel and placebo treatment groups in the incidence of EPS or concomitant use of anticholinergics.
Danish: I tre placebo-kontrollerede kliniske studier med skizofrene patienter sås ved brug af variable doser af quetiapin ingen forskelle mellem Seroquel- og placebo-grupperne i forekomsten af EPS eller samtidig anvendelse af anticholinerge stoffer.
English: In a clinical trial to evaluate the cataractogenic potential of Seroquel (200-800 mg/ day) versus risperidone (2-8 mg/day) in patients with schizophrenia or schizoaffective disorder, the percentage of patients with increased lens opacity grade was not higher in Seroquel (4%) compared with risperidone (10%), for patients with at least 21 months of exposure.
Danish: I et klinisk studie, der skulle evaluere det kataraktogene potentiale ved Seroquel (200-800 mg/dag) over for risperidon (2-8 mg/dag) hos til patienter med skizofreni eller skizoaffektiv sindslidelse var procentdelen af patienter med øget linseuklarhed ikke højere for Seroquel (4 %) sammenlignet med risperidon (10 %), hos patienter, der var blevet udsat for lægemidlet i mindst 21 måneder.
English: In particular, reports of adverse events related to EPS and weight gain did not increase with longer-term treatment with Seroquel XR.
Danish: Der blev for eksempel ikke rapporteret flere bivirkninger relateret til EPS og vægtøgning ved langtidsbehandling med Seroquel Prolong.
English: The mean plasma clearance of quetiapine was reduced by 30% to 50% in elderly patients when compared to younger patients.
Danish: Quetiapins gennemsnitlige plasmaclearance var reduceret med 30 % til 50 % hos ældre, sammenlignet med yngre patienter.
English: Calculation of Frequency for these ADR's have been taken from postmarketing data only.
Danish: (5) Udregning af bivirkningsfrekvens stammer udelukkende fra postmarketing data.
English: BATCH NUMBER LOT
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: Due to lack of robust data, a decision must be made whether to discontinue breast-feeding or to discontinue Seroquel XR therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Grundet manglen på robuste data skal det besluttes, om amning eller behandling med Seroquel Prolong skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: If you are not sure, talk to your doctor or pharmacist before taking Seroquel.
Danish: Hvis du er usikker, så tal altid med din læge eller apoteket, inden du tager Seroquel.
English: For the treatment of moderate to severe manic episodes in bipolar disorder For the treatment of manic episodes associated with bipolar disorder, Seroquel should be administered twice a day.
Danish: Til behandling af moderate til svære maniske episoder inden for bipolar lidelse Til behandling af maniske episoder i forbindelse med bipolær lidelse, bør Seroquel tages to gange dagligt.
English: The rate of dose titration of Seroquel XR may need to be slower, and the daily therapeutic dose lower, than that used in younger patients.
Danish: Der kan være behov for en langsommere dosistitrering og en lavere daglig terapeutisk dosis af Seroquel Prolong end hos yngre patienter.
English: Inhibition of NET and partial agonist action at 5HT1A sites by norquetiapine may contribute to Seroquel's therapeutic efficacy as an antidepressant.
Danish: Norquetiapins hæmning af NET og delvise agonistvirkning på 5HT1A-stederne kan medvirke til Seroquel Prolongs terapeutiske virkning som et antidepressivum.
English: What you need to know before you take Seroquel
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE SEROQUEL
English: 6.5 Nature and contents of container Polychlorotrifluoroethylene and polyvinylchloride with aluminium blister
Danish: Blisterkort af polychlortrifluorethylen og polyvinylchlorid med aluminium.
English: When Seroquel XR is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another drug being used to treat this illness.
Danish: Hvis Seroquel Prolong tages mod depressive episoder ved unipolar depression, skal det tages sammen med anden medicin, som gives mod denne sygdom.
English: Neuroleptic malignant syndrome 1, hypothermia
Danish: Malignt neuroleptikasy ndrom1, hypotermi