FrancophonIA/ELRC3.0 huggingface dataset:
English: In short-term clinical trials with Seroquel in paediatric patients (10-17 years of age), 17% of quetiapine treated patients and 2.5% of placebo treated patients gained ≥7% of their body weight.
Danish: I korttids kliniske forsøg med Seroquel med pædiatriske patienter (10-17 år) øgede 17 % af quetiapinbehandlede og 2,5 % af placebobehandlede patienter deres kropsvægt ≥7 %.
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 clearence af quetiapin på ca. 450%.
English: The efficacy of Seroquel XR in the treatment of schizophrenia was demonstrated in one 6-week placebo-controlled trial in patients who met DSM-IV criteria for schizophrenia, and one activecontrolled 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 forsøg med patienter, som opfyldte DSM-IV kriteriet for skizofreni og i ét aktivt kontrolleret forsøg med skift fra Seroquel tabletter til Seroquel Prolong hos stabile ikke-hospitaliserede patienter med skizofreni.
English: - The CHMP considered whether it was appropriate to introduce Seroquel XR, at 50 - 300 mg/day to a population of patients with major depressive disorders, excluding the use as initial treatment and used when patients cannot be appropriately managed on alternative antidepressant treatment.
Danish: - CHMP overvejede, om det var hensigtsmæssigt at medtage Seroquel XR med en dosis på 50300 mg/dag til en patientpopulation med svær depression, idet man udelukker brugen som indledende behandling og anvender lægemidlet, når patienterne ikke kan behandles på en tilstrækkelig måde med alternative antidepressiva,
English: As with other antipsychotics and antidepressants, Seroquel XR should be used with caution in the elderly, especially during the initial dosing period.
Danish: Seroquel Prolong bør som andre antipsykotika og antidepressiva anvendes med forsigtighed til ældre, især i den indledende doseringsperiode.
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 monoterapiforsøg 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: Dysphagia8
Danish: Dysfagi8
English: Dizziness4, 17, somnolence 2, 17, headache
Danish: Svimmelhed4,17, døsighed 2,17, hovedpine
English: Furthermore, although lack of long-term efficacy data for add-on treatment was acknowledged, the CHMP agreed with extrapolation from the monotherapy relapse prevention study.
Danish: Selv om der manglede data for tillægsbehandlingens langtidsvirkning, godkendte CHMP desuden ekstrapoleringen fra undersøgelsen af tilbagefaldsforebyggelse (monoterapi).
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.
English: Somnolence and dizziness:
Danish: Døsighed og svimmelhed:
English: An application for a type II variation to the terms of the Marketing Authorisation of Seroquel XR (NL/H/156/08-011/II/058) submitted by the marketing authorisation holder (MAH), Astra Zeneca AB, via Mutual Recognition Procedure (MRP) to include treatment of recurrent episodes in patients with Major Depressive Disorders (MDD), excluding the use as initial treatment and used when patients cannot be appropriately managed on alternative antidepressant treatment was rejected by all involved Member States on 15 May 2009.
Danish: Den 15. maj 2009 afviste alle de berørte medlemsstater en ansøgning om en type II-ændring af betingelserne for markedsføringstilladelsen for Seroquel XR (NL/H/156/08-011/II/058), der var indgivet af indehaveren af markedsføringstilladelsen, Astra Zeneca AB, via den gensidige anerkendelsesprocedure med henblik på at medtage behandling af tilbagevendende episoder hos patienter med svær depression (MDD), idet man udelukker brugen som indledende behandling og anvender lægemidlet, når patienterne ikke kan behandles på en tilstrækkelig måde med alternative antidepressiva.
English: In the 6-week active-controlled switching study the primary outcome variable was the proportion of patients who showed lack of efficacy, ie, who discontinued study treatment due to lack of efficacy or whose PANSS total score increased 20% or more from randomization to any visit.
Danish: I det 6-ugers aktivt kontrollerede forsøg med skift fra Seroquel til Seroquel Prolong var den primære effektparameter andelen af patienter med manglende effekt, defineret som stop af behandlingen på grund af manglende effekt eller øgning af PANSS total med 20 % eller mere, målt fra randomisering til ethvert besøg.
English: Seizure 1, Restless legs syndrome, Tardive dyskinesia 1, 6
Danish: Krampe 1, uro i benene Tardiv dyskinesi1,6
English: COUNTRY
Danish: LAND
English: Neuroleptic Malignant Syndrome:
Danish: Malignt neuroleptikasyndrom:
English: Azole medicines (for fungal infections).
Danish: lægemidler som indeholder azoler (mod svampeinfektioner).
English: Keep the Seroquel XR tablets with you.
Danish: Tag Seroquel Prolong tabletterne med dig.
English: The daily dose at the start of therapy is 300 mg on Day 1 and 600 mg on Day 2.
Danish: Ved behandlingstart er den daglige dosis 300 mg på dag 1 og 600 mg på dag 2.
English: 6.5 Nature and contents of container Polychlorotrifluoroethylene and polyvinylchloride with aluminium blister
Danish: 6.5 Emballagetype og pakningsstørrelser Blisterkort af polychlortrifluorethylen og polyvinylchlorid med aluminium.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Kerne
English: Cytochrome P450 (CYP) 3A4 is the enzyme that is primarily responsible for the cytochrome P450 mediated metabolism of quetiapine.
Danish: Cytochrom P450 (CYP) 3A4 er det primære enzym ved cytochrom P450 medieret metabolisme af quetiapin.
English: (20) Cases of suicidal ideation and suicidal behaviours have been reported during Seroquel XR therapy or early after treatment discontinuation (see Sections 4.4 and 5.1).
Danish: (20) Der er blevet rapporteret om selvmordstanker og selvmordsadfærd under behandlingen med Seroquel Prolong samt efter behandling ophør (se pkt.
English: The CHMP concluded that there is potential benefit in the use of quetiapine as an add-on treatment of major depressive episodes in patients with MDD who have sub-optimal response to antidepressant monotherapy.
Danish: CHMP konkluderede, at der er en potentiel fordel ved brugen af quetiapin som tillægsbehandling af svære depressive episoder hos MDD-patienter, som responderer suboptimalt på antidepressiv monoterapi.
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: Stigninger i blodtryk blev rapporteret hos børn og unge, og øget appetit, ekstrapyramidale symptomer og forhøjelser i serumprolaktin blev rapporteret med større hyppighed hos børn og unge end hos voksne patienter (se pkt.
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: Weight gain has been seen in patients taking Seroquel XR.
Danish: Der er observeret vægtøgning hos patienter, der tager Seroquel Prolong.
English: In vitro investigations established that CYP3A4 is the primary enzyme responsible for cytochrome P450 mediated metabolism of quetiapine.
Danish: In vitro undersøgelser påviste, at CYP3A4 er det primære enzym, ansvarligt for cytochrom P450 medieret metabolisme af quetiapin.
English: Tablet core: microcrystalline cellulose, sodium citrate, lactose monohydrate, magnesium stearate, hypromellose.
Danish: • Øvrige indholdsstoffer: Tabletkerne: Mikrokrystallinsk cellulose, natriumcitrat, lactosemonohydrat, magnesiumstearat, hypromellose.
English: In one long-term study (up to 2 years treatment) evaluating recurrence prevention in patients with manic, depressed or mixed mood episodes quetiapine was superior to placebo in increasing the time to recurrence of any mood event (manic, mixed or depressed), in patients with bipolar I disorder.
Danish: I et langtidsforsøg (op til 2 års behandling) hvor man evaluerede forebyggelse af tilbagevendende sygdomsepisoder hos patienter med maniske, deprimerede eller blandede stemningsepisoder var quetiapin bedre end placebo til at øge tiden til tilbagevendende sygdomsepisoder for enhver stemningshændelse (manisk, blandet eller deprimeret) hos patienter med bipolar I lidelse.
English: • treatment of major depressive episodes in bipolar disorder.
Danish: • Behandling af svære depressive episoder inden for bipolær lidelse.
English: Carton (pack) contents Blisters
Danish: Karton(paknings)indhold
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 og tolerabilitet forbundet med Seroquel Prolong behandling i op til 9 måneder (median 7 måneder).
English: Based on the above, the benefit risk is considered positive for Seroquel XR as add-on treatment of major depressive episodes in patients with major depressive disorder, who have had suboptimal response to initial antidepressant mono-therapy subject to conditions of the marketing authorisation.
Danish: På baggrund af ovenstående anses benefit/risk-forholdet for at være positivt for Seroquel XR som tillægsbehandling af svære depressive episoder hos patienter med svær depression, der har responderet suboptimalt på indledende antidepressiv monoterapi underlagt betingelserne i markedsføringstilladelsen.
English: In patients receiving a hepatic enzyme inducer, initiation of Seroquel XR treatment should only occur if the physician considers that the benefits of Seroquel XR outweigh the risks of removing the hepatic enzyme inducer.
Danish: Hos patienter som er i behandling med en leverenzyminducer, bør initiering af Seroquel Prolong kun ske, såfremt lægen vurderer, at fordelene ved Seroquel Prolong overstiger risici ved at stoppe behandlingen med leverenzyminduceren.
English: Extrapyramidal symptoms3
Danish: Ekstrapyramidale symptomer3
English: Efficacy Six studies in monotherapy and two add-on treatment studies were submitted by the MAH.
Danish: Indehaveren af markedsføringstilladelsen fremlagde seks monoterapiundersøgelser og to tillægsbehandlingsundersøgelser.
English: 100 blisters of 1 tablet
Danish: 100 blistre á 1 tablet
English: If you take more Seroquel XR than you should If you take more Seroquel XR than prescribed by your doctor, you may feel sleepy, feel dizzy and experience abnormal heart beats.
Danish: Hvis du har taget for mange Seroquel Prolong depottabletter Hvis du tager flere Seroquel Prolong end lægen har anbefalet, kan du føle dig søvnig og svimmel og få en unormal hjerterytme (puls).
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: 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 korttidsforsøg 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 quitiapin og 11,4 % for placebo).
English: • treatment of moderate to severe manic episodes in bipolar disorder.
Danish: • Behandling af moderate til svære maniske episoder inden for bipolær lidelse.
English: If you are, Seroquel XR should not be taken because the group of medicines that Seroquel XR belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
Danish: Seroquel Prolong må ikke tages af ældre demente personer, fordi Seroquel Prolong kan øge risikoen for slagtilfælde, og i nogle tilfælde dødsfald, hos disse personer.
English: In placebo-controlled trials with quetiapine the mean change and the incidence of patients who have a shift to a clinically significant level is similar between quetiapine and placebo.
Danish: I placebo-kontrollerede quetiapinforsøg var gennemsnitsændringen og hyppigheden af patienter, som har skift til et klinisk signifikant niveau ens mellem quetiapin og placebo.
English: However in two 10-week placebo controlled quetiapine studies in the same patient population (n=710; mean age: 83 years; range: 56-99 years) the incidence of mortality in quetiapine treated patients was 5.5% versus 3.2% in the placebo group.
Danish: Dog var mortalitetshyppigheden hos quetiapin behandlede patienter i to 10-ugers placebo-kontrollerede quetiapin forsøg i samme patientpopulation (n=710; gennemsnitsalder: 83 år, interval: 56-99 år) 5,5 % mod 3,2 % i placebogruppen.
English: The most commonly reported Adverse Drug Reactions (ADRs) with quetiapine are somnolence, dizziness, dry mouth, mild asthenia, constipation, tachycardia, orthostatic hypotension and dyspepsia.
Danish: De hyppigst indrapporterede bivirkninger for quetiapin er somnolens, svimmelhed, mundtørhed, mild asteni, forstoppelse, tachycardia, ortostatisk hypotension og dyspepsi.
English: In 4 additional clinical trials with quetiapine, with a duration of 8 weeks in patients with moderate to severe depressive episodes in bipolar I or bipolar II disorder, Seroquel IR 300 mg and 600 mg was significantly superior to placebo treated patients for the relevant outcome measures: mean improvement on the MADRS and for response defined as at least a 50% improvement in MADRS total score from baseline.
Danish: I yderligere 4 kliniske forsøg med quetiapin, med en varighed på 8 uger hos patienter med moderate til svære depressive episoder inden for bipolar I og bipolar II lidelse, var Seroquel 300 mg og 600 mg signifikant bedre end placebobehandlede patienter for de relevante effektmål: MADRS gennemsnitsforbedring og for respons defineret som mindst en 50 % forbedring i MADRS totalscore fra baseline.
English: In a study examining the effects of food on the bioavailability of quetiapine, a high-fat meal was found to produce statistically significant increases in the Seroquel XR Cmax and AUC of approximately 50% and 20% respectively., It cannot be excluded that the effect of a high fat meal on the formulation may be larger.
Danish: I et forsøg hvor man undersøgte effekten af føde på biotilgængeligheden af quetiapin, blev der fundet, at et måltid med et højt fedtindhold medførte signifikante stigninger i Seroquel Prolongs Cmax og AUC på henholdsvis ca. 50 % og 20 %.
English: • Do not use Seroquel XR 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. Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
English: The effect size of the 600 mg and 800 mg doses was greater than that of the 400 mg dose.
Danish: Effekten på PANSS total var numerisk større for 600 mg og 800 mg end for 400 mg.
English: Always take Seroquel XR exactly as your doctor has told you.
Danish: Tag altid Seroquel Prolong efter lægens anvisning.
English: A meta analysis of placebo controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Danish: En metaanalyse af placebokontrollerede kliniske forsøg med antidepressiva hos voksne patienter med psykiske lidelser viste en øget risiko for selvmordsadfærd ved antidepressiva sammenlignet med placebo hos patienter under 25 år.
English: In placebo-controlled studies in elderly patients with dementia-related psychosis, the incidence of cerebrovascular adverse events per 100 patient years was not higher in quetiapine-treated patients than in placebo-treated patients.
Danish: I placebo-kontrollerede forsøg med ældre patienter med demens relateret psykose var hyppigheden af cerebrovaskulære bivirkninger pr. 100 patientår ikke højere hos quetiapin-behandlede patienter end hos placebo-behandlede patienter.
English: These include difficulty starting muscle movements, shaking,
Danish: Der kan være problemer med at få gang i musklerne, rysten,
English: Investigations Very common Elevations in serum triglyceride levels 11
Danish: Forhøjede serumtriglyceridniveauer11
English: Thoughts of suicide and worsening of your depression If you are depressed you may sometimes have thoughts of harming or killing yourself.
Danish: Hvis du er deprimeret, kan det være, at du ind imellem tænker på at skade dig selv eller begå selvmord.
English: • Increase in the amount of a hormone called prolactin, in the blood.
Danish: Stigninger i mængden af hormonet prolaktin i blodet.
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: In a short-term placebo-controlled monotherapy trial with Seroquel in children and adolescent patients (10-17 years of age) with bipolar mania, the aggregated incidence of extrapyramidal symptoms was 3.6% for quetiapine and 1.1% for placebo.
Danish: I et korttids placebo-kontrolleret monoterapiforsøg med Seroquel med børn og unge patienter (10-17 år) med bipolar mani var den samlede forekomst af ekstrapyramidale symptomer 3,6 % for quetiapin og 1,1 % for placebo.
English: Other than the incidence of extrapyramidal symptoms (see section 4.8 and ‘Clinical Safety' below) the tolerability of Seroquel XR once daily in elderly patients was comparable to that seen in adults (aged 18-65 years).
Danish: 4,8 og ”Klinisk sikkerhed” nedenfor) svarede tolerabiliteten for Seroquel Prolong givet én gang dagligt til ældre patienter til den, som sås hos voksne i alderen 18-65 år.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ OG INDLÆGSSEDDEL
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 forsøg og ved anvendelse i henhold til produktresuméet ikke forbundet med vedvarende forlængelse af QT-intervaller.
English: The short-term monotherapy studies showed that patients treated with quetiapine had more adverse events and a higher dropout rate due to adverse events when compared to the active controlsSelective serotonin reuptake inhibitor - duloxetine and escitalopram.
Danish: Korttidsundersøgelserne af monoterapi viste, at patienter behandlet med quetiapin havde flere utilsigtede hændelser og en højere andel af patienter, der udgik af undersøgelsen som følge af utilsigtede hændelser, end de aktive kontrolstoffer duloxetin og escitalopram (selektive serotoningenoptagelseshæmmere).
English: In two recurrence prevention studies evaluating quetiapine in combination with mood stabilizers, in patients with manic, depressed or mixed mood episodes, the combination with quetiapine was superior to mood stabilizers monotherapy in increasing the time to recurrence of any mood event (manic, mixed or depressed).
Danish: I to kliniske forsøg til forebyggelse af tilbagevendende sygdomsepisoder hvor quetiapin blev evalueret i kombination med stemningsstabiliserende behandling hos patienter med maniske, depressive eller blandede sygdomsepisoder var kombinationen med quetiapin bedre end stemningsstabiliserende monoterapi med hensyn til at øge tiden til tilbagevendende sygdomsepisoder (manisk, blandet eller depressiv).
English: ¾ General Practice Research Database (GPRD) Study;
Danish: ¾ M-PEM-undersøgelse (ændret overvågning af behandlingsforløb), ¾ GPRD-undersøgelse (General Practice Research Database).
English: In shorter-term placebo controlled clinical studies of patients with major depressive episodes in bipolar disorder an increased risk of suicide-related events was observed in young adults patients (younger than 25 years of age) who were treated with quetiapine as compared to those treated with placebo (3.0% vs. 0%, respectively).
Danish: I placebokontrollerede, kliniske korttidsforsøg med patienter med depressive episoder inden for bipolar lidelse sås en øget risiko for selvmordsrelaterede hændelser hos unge voksne patienter under 25 år, som blev behandlet med quetiapin sammenlignet med dem, som fik placebo (3,0 % versus 0 %).
English: In short-term placebo-controlled trials with Seroquel in paediatric patients with bipolar mania, the incidence of suicide related events was 1.0% (2/193) for quetiapine and 0% (0/90) for placebo in patients <18 years of age.
Danish: I korttids placebo-kontrollerede forsøg med Seroquel med pædiatriske patienter med bipolar mani var forekomsten af selvmordsrelaterede hændelser 1,0 % (2/193) for quetiapin og 0 % (0/90) for placebo hos patienter på <18 år.
English: In placebo-controlled monotherapy trials in patients with a baseline neutrophil count ≥ 1.5 X 109/L, the incidence of at least one occurrence of neutrophil count <1.5 X 109/L, was 1.72% in patients treated with quetiapine compared to 0.73% in placebo-treated patients.
Danish: I placebo-kontrollerede monoterapiforsøg hos patienter med et baseline neutrofiltal ≥1,5 x 109/l var hyppigheden af mindst ét tilfælde af et neutrofiltal <1,5 x 109/l hos quetiapin behandlede patienter 1,72 % sammenlignet med 0,73 % hos de patienter, som fik placebo.
English: Switching from Seroquel immediate-release tablets:
Danish: Skift fra Seroqueltabletter:
English: Elderly people If you are elderly your doctor may change your dose.
Danish: Din læge vil muligvis ændre din dosis, hvis du er en ældre person.
English: NO- Norway AstraZeneca AS, Hoffsveien 70B, (PO Box 200),
Danish: AstraZeneca AS, Hoffsveien 70B, (PO Box 200), 0319 Oslo, Norge
English: Diabetes Mellitus 1,5,6, Psychiatric disorders Common:
Danish: Diabetes mellitus1,5,6
English: Metabolism and nutritional disorders Common:
Danish: Metabolisme og ernæring: Almindelig:
English: Pharmacotherapeutic group: Antipsychotics; Diazepines, oxazepines and thiazepines ATC code: N05A H04
Danish: Farmakoterapeutisk klassifikation: Antipsykotika; diazepiner, oxazepiner og thiazepiner.