FrancophonIA/ELRC3.0 huggingface dataset:
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 SEROQUEL XR 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 Seroquel Prolong og forebyggende foranstaltninger skal foretages.
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 (YMRSforbedring ≥50 %) var 64 % for Seroquel 400 mg/dag, 58% for 600 mg/dag og 37 % i placebogruppen.
English: Interactions: See also section 4.5.
Danish: Interaktioner: Se desuden pkt.
English: The mean quetiapine plasma clearance decreases with approximately 25% in persons with known hepatic impairment (stable alcoholcirrhosis).
Danish: Quetiapins gennemsnitlige plasmaclearence er reduceret med ca. 25 % hos individer med nedsat leverfunktion (stabil alkoholisk cirrhosis).
English: As for other antipsychotic agents, the exact mechanism of action of quetiapine is unknown but the combination of receptor antagonism with a higher selectivity for serotonin 5HT2 relative to dopamine D2 receptors may contribute to its psychotropic activity and mood stabilizing properties.
Danish: Ligesom det er tilfældet med andre antipsykotiske midler, er quetiapins nøjagtige virkningsmekanisme ukendt, men kombinationen af receptorantagonisme med en højere selektivitet over for serotonin 5HT2 i forhold til dopamin D2receptorer menes at medvirke til dets psykotropiske aktivitet og dets humørstabiliserede egenskaber.
English: If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Seroquel XR should be considered.
Danish: Hvis der udvises tegn og symptomer på tardiv dyskinesi, bør det overvejes, om Seroquel Prolong dosis skal reduceres eller behandlingen ophøre.
English: Also caution should be exercised when quetiapine is prescribed either with medicines known to increase QT interval, or with concomitant neuroleptics, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia or hypomagnesaemia (see section 4.5).
Danish: Forsigtighed bør også udvises, når quetiapin ordineres enten sammen med lægemidler, der er kendt for at øge QT-intervallet eller med samtidig neuroleptika, specielt hos ældre, hos patienter med medfødt langt QT-syndrom, hjerteinsufficiens, hjertehypertrofi, hypokalæmi eller hypomagnesæmi (se pkt.
English: In individual patients, in the event of tolerance concerns, clinical trials have indicated that dose reduction to a minimum of 200 mg could be considered.
Danish: Kliniske forsøg har indikeret, at ved mistanke om toleransudvikling hos enkelte patienter kan en reduktion af dosis til minimum 200 mg overvejes.
English: The mean plasma clearance of quetiapine was reduced by approximately 25% in subjects with severe renal impairment (creatinine clearance less than 30 ml/min/1.73 m2), but the individual clearance values are within the range for normal subjects.
Danish: Quetiapins gennemsnitlige plasmaclearence blev reduceret med ca. 25 % hos individer med svært nedsat nyrefunktion (kreatininclearence mindre end 30 ml/min/1,73 m2), men de individuelle clearenceværdier ligger inden for normalområdet.
English: (See section 4.4: Cardiovascular).
Danish: 4.4: Kardiovaskulær).
English: In clinical trials for treatment of patients with bipolar depression and major depressive disorder, onset was usually within the first 3 days of treatment and was predominantly of mild to moderate intensity.
Danish: I kliniske forsøg med patienter med bipolar depression og unipolar depression indtrådte det sædvanligvis inden for de første 3 dages behandling, og intensiteten var hovedsagelig mild til moderat.
English: Children and adolescents under 18 years Seroquel XR should not be used by children and adolescents aged under 18 years.
Danish: Børn og unge under 18 år Børn og unge under 18 år må ikke anvende Seroquel Prolong.
English: The degree to which quetiapine is excreted into human milk is unknown.
Danish: Det vides ikke i hvor høj grad quetiapin udskilles i modermælken.
English: • Take your tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when.
Danish: - Tag tabletterne uden samtidig fødeindtagelse (mindst 1 time før et måltid, eller ved sengetid.
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 dagligt totalt 400 mg til 800 mg per dag som kombinationsbehandling med lithium eller valproat.
English: Mild asthenia, peripheral oedema, irritability
Danish: Mild asteni, perifært ødem, irritabilitet
English: PL - Poland AstraZeneca UK Limited, 15 Stanhope Gate,
Danish: AstraZeneca UK Limited, 15 Stanhope Gate, London
English: Metabolic Risk
Danish: Metabolisk risiko:
English: During post-marketing experience, resolution of leucopenia and/or neutropenia has followed cessation of therapy with quetiapine.
Danish: Erfaringer opnået efter markedsføring viser, at leukopeni og/eller neutropeni forsvinder igen efter stop af behandling med quetiapin.
English: It is recommended that Seroquel XR is taken once daily without food.
Danish: Det anbefales, at Seroquel Prolong tages én gang dagligt uden samtidig fødeindtagelse.
English: In such an event, Seroquel XR should be discontinued and appropriate medical treatment given.
Danish: I sådanne tilfælde bør behandlingen med Seroquel Prolong ophøre og passende medicinsk behandling påbegyndes.
English: Prior to initiating treatment, clinicians should consider the safety profile of SEROQUEL XR (see Section
Danish: 5.1) Inden behandlingen indledes, bør klinikerne tage højde for sikkerhedsprofilen for SEROQUEL PROLONG (se pkt.
English: The CHMP, based on the data available and further to consultation of the clinical neuroscience scientific advisory group (SAG-CNS), considered that efficacy in the therapeutic indication applied by the MAH, i.e., monotherapy in patients with recurrent major depression episodes that cannot be appropriately managed with alternative antidepressants, was not explicitly studied in the performed studies.
Danish: På baggrund af de tilgængelige data og efter høring af den videnskabelige rådgivende gruppe for klinisk neurovidenskab (SAG-CNS) var CHMP af den opfattelse, at virkningen i den terapeutiske indikation, som indehaveren af markedsføringstilladelsen ansøger om, dvs. monoterapi hos patienter med tilbagevendende svære depressive episoder, der ikke kan behandles på en tilstrækkelig måde med alternative antidepressiva, ikke var blevet udtrykkeligt undersøgt i de foretagne undersøgelser.
English: In a meta-analysis of atypical antipsychotics, it has been reported that elderly patients with dementiarelated psychosis are at an increased risk of death compared to placebo.
Danish: I en metaanalyse af atypiske antipsykotika er det blevet rapporteret, at ældre patienter med demens relateret psykose er i øget risiko for at dø sammenlignet med placebo.
English: The short-term efficacy demonstrated in the two add-on studies in patients with inadequate response to initial antidepressant monotherapy treatment balanced positively with the already know safety profile of quetiapine.
Danish: Den kortsigtede virkning, der blev påvist i de to tillægsbehandlingsundersøgelser hos patienter med en utilstrækkelig respons på indledende antidepressiv behandling som monoterapi, var positiv i forhold til quetiapins velkendte sikkerhedsprofil.
English: Quetiapine and the active human plasma metabolite, norquetiapine interact with a broad range of neurotransmitter receptors.
Danish: Quetiapin og den aktive humane plasmametabolit, norquetiapin indvirker på en bred vifte af neurotransmitterreceptorer.
English: Bipolar depression patients and patients with major depressive episodes in MDD experiencing somnolence of severe intensity may require more frequent contact for a minimum of 2 weeks from onset of somnolence, or until symptoms improve and treatment discontinuation may need to be considered.
Danish: Patienter med bipolar depression og patienter med depressive episoder med unipolar depression, som får døsighed i svær grad, kan have brug for hyppigere kontakt i minimum 2 uger fra døsighed indtræder, eller indtil symptomerne forbedres, og det kan være nødvendigtat overveje seponering.
English: In the relapse prevention study (monotherapy), also in unrestricted MDD population but after 14 to 26 weeks of open label treatment, responders were randomised to continuing quetiapine treatment or placebo for up to 52 weeks and showed significant and clinically relevant results in favour of active treatment.
Danish: I undersøgelsen af tilbagefaldsforebyggelse (monoterapi), som også fandt sted hos en ikkeafgrænset MDD-population, men efter 14-26 ugers åben behandling, blev de responderende patienter randomiseret til at fortsætte med quetiapinbehandling eller placebo i op til 52 uger, og de viste signifikante og klinisk relevante resultater til fordel for aktiv behandling.
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 bør tages mindst 1 time før et måltid.
English: Based on these in vitro results, it is unlikely that coadministration of quetiapine with other drugs will result in clinically significant drug inhibition of cytochrome P450 mediated metabolism of the other drug.
Danish: På basis af disse in vitro resultater, er det usandsynligt, at samtidig indgift af quetiapin og anden medicin, vil resultere i klinisk signifikant lægemiddel inhibering af cytochrom P450 medieret metabolisme af det andet stof.
English: - The Committee considered the referral made under article 6(13) Commission Regulation (EC) No 1084/2003, for Seroquel XR and associated names initiated by the MAH (see annex I).
Danish: - Udvalget behandlede den indbringelse, som indehaveren af markedsføringstilladelsen havde foretaget i henhold til artikel 6, stk. 13, i Kommissionens forordning (EF) nr. 1084/2003 for Seroquel XR og tilknyttede navne (se bilag I),
English: The incidence of relapse was 14.2% for Seroquel XR treated patients and 34.4% for placebotreated patients.
Danish: Recidivhyppigheden var 14,2 % for Seroquel Prolong-behandlede patienter og 34,4 % for placebo-behandlede patienter.
English: (18) HDL cholesterol: <40 mg/dL (1.025 mmol/L) males; <50 mg/dL (1.282 mmol/L) females at any time.
Danish: (18) HDL-kolesterol: <40 mg/dl (1,025 mmol/l) hankøn; <50 mg/dl (1,282 mmol/l) hunkøn ved ethvert tidspunkt.
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: Den anbefalede dosis er 300 mg. I kliniske forsøg sås der ingen yderligere fordel i 600 mg gruppen i forhold til 300 mg gruppen (se pkt.
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 ekvivalent Seroquel Prolong dosis givet én gang dagligt.
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 dagligt, hvis det er klinisk begrundet.
English: Elevations in total cholesterol (predominantly LDL cholesterol) 12, Decreases in HDL cholesterol18, Weight gain9
Danish: Forhøjet total-kolesterol (hovedsagelig LDL-kolesterol)12, fald i HDL-kolesterol, vægtøgning9
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-forsøg i patienter til bestemmelse af quetiapins pharmakokinetik når det administreres hhv. før og samtidig med carbamazepin (en kendt leverenzym- inducer), gav samtidig behandling med carbamazepin en signifikant øget quetiapin clearence.
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 quetiapins plasmakoncentration, hvilket kan påvirke effekten af quetiapinbehandling.
English: (4) As with other antipsychotics with alpha1 adrenergic blocking activity, quetiapine may commonly induce orthostatic hypotension, associated with dizziness, tachycardia and, in some patients, syncope, especially during the initial dose-titration period.
Danish: (4) Som for andre antipsykotika med α1 blokerende adrenerg aktivitet kan quetiapin specielt i den indledende dosis titreringsperiode inducere ortostatisk hypotension forbundet med svimmelhed, tachycardia, og hos nogle patienter besvimelse (se pkt.
English: The most commonly noted adverse reactions with quetiapine were dry mouth, sedation, and somnolence while nausea and headache were more commonly noted with the active controls.
Danish: De mest almindelige utilsigtede hændelser med quetiapin var mundtørhed, sedation og somnolens, mens kvalme og hovedpine var mere almindelige med de aktive kontrolstoffer.
English: Seroquel XR should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension.
Danish: Seroquel Prolong bør anvendes med forsigtighed til patienter med kendt kardiovaskulær sygdom, cerebrovaskulær sygdom eller andre tilstande, hvor patienten er disponeret for hypotension.
English: - The CHMP concluded that the Product Information of quetiapine should reflect the current lack of long-term data of quetiapine as add-on treatment of major depressive episodes in patients with major depressive disorder, who have had suboptimal response to initial antidepressant mono-therapy and therefore recommended the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet.
Danish: - CHMP konkluderede, at produktinformationen for quetiapin bør afspejle den nuværende mangel på langtidsdata for quetiapin som tillægsbehandling af svære depressive episoder hos patienter med svær depression, der har responderet suboptimalt på indledende antidepressiv monoterapi, og CHMP anbefalede derfor ændringerne af de relevante punkter i produktresuméet og indlægssedlen,
English: Lipids:
Danish: Lipider:
English: As Seroquel XR is indicated for the treatment of schizophrenia, bipolar disorder and add-on treatment of major depressive episodes in patients with MDD, the safety profile should be considered with respect to the individual patient's diagnosis and the dose being administered.
Danish: Da Seroquel Prolong er indiceret til behandling af skizofreni, bipolar lidelse og supplerende behandling ved depressive episoder hos patienter med unipolar depression skal der tages højde for sikkerhedsprofilen med hensyn til patientens individuelle diagnose og den administrerede dosis.
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 defor monitoreres grundigt, under behandlingen.
English: Elevations in gamma-GT levels3, Platelet count decreased14, QT prolongation 1,13, 19
Danish: Gamma-GT forhøjelse3, fald i blodpladetallet14 QT forlængelse1,13,19
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 forsøg sås ingen forskel i hyppigheden af krampeanfald hos patienter behandlet med quetiapin eller placebo.
English: Abnormal dreams and nightmares Suicidal ideation and suicidal behaviour20
Danish: Selvmordstanker og selvmordsadfærd20
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 interaktionsforsøg hos raske forsøgspersoner medførte samtidig administrering af quetiapin (25 mg) og ketoconazol (CYP 3A4 inhibitor) en faktor 5 til 8 stigning i quetiapins AUC.
English: Reproductive system and breast disorders Rare:
Danish: Det reproduktive system og mammae Sjælden
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.
English: • Feeling irritated
Danish: • Irritation.
English: Neuroleptic malignant syndrome 1
Danish: Malignt neuroleptikasyndrom1
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 langtidsforsøg med stabiliserede skizofrenipatienter fastholdt på Seroquel Prolong i 16 uger, var Seroquel Prolong mere effektiv end placebo i forebyggelse af tilbagefald.
English: The efficacy of Seroquel XR was further demonstrated with significance versus placebo in an additional 3 week study.
Danish: Seroquel Prolongs effekt blev også vist med signifikant forskel i forhold til placebo i yderligere et 3 ugers forsøg.
English: • Seroquel XR does not require any special storage conditions.
Danish: Seroquel Prolong kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Seroquel (quetiapine fumarate), prolonged release tablets (XR) at strength of 50 mg, 150 mg, 200 mg, 300 mg and 400 mg is authorised in the European Union via the Mutual Recognition and Decentralised procedures for the following indications:
Danish: Seroquel (quetiapinfumarat) depottabletter (XR) i en styrke på 50 mg, 150 mg, 200 mg, 300 mg og 400 mg er godkendt i Den Europæiske Union via den gensidige anerkendelsesprocedure og den decentrale procedure til følgende indikationer:
English: Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatinine phosphokinase.
Danish: Kliniske tegn er bl.a. hypertermi, bevidsthedsændring, muskelstivhed, autonome forstyrrelser og forhøjet kreatininfosfokinase.
English: Quetiapine and norquetiapine exhibit affinity for brain serotonin (5HT2) and dopamine D1- and D2- receptors.
Danish: Quetiapin og norquetiapin udviser affinitet for serotonin (5HT2) receptorer og for dopamin D1 og D2 receptorer i hjernen.
English: • treatment of Schizophrenia, including o preventing relapse in stable schizophrenic patients who have been maintained on Seroquel XR.
Danish: • Behandling af skizofreni, herunder forebyggelse af tilbagefald hos stabile skizofrenipatienter, der stadig behandles med Seroquel XR.
English: If you are not sure, talk to your doctor or pharmacist before taking Seroquel XR.
Danish: Hvis du er usikker, så tal altid med din læge eller apoteket, inden du tager Seroquel Prolong.
English: In a long-term open label study with Seroquel of schizophrenia and bipolar mania, the aggregated incidence of treatment-emergent EPS was 10%.
Danish: I et langtids open-label forsøg med Seroquel af skizofreni og bipolar mania var den samlede forekomst af EPS opstået under behandling 10 %.
English: Weight gain has been reported in patients who have been treated with quetiapine, and should be monitored and managed as clinically appropriate as in accordance with utilised antipsychotic guidelines (see Sections 4.8 and 5.1).
Danish: Der er blevet rapporteret vægtøgning hos patienter, som er blevet behandlet med quetiapin, og patienterne bør derfor monitoreres og behandles klinisk hensigtsmæssigt i overensstemmelse med de gældende retningslinjer for antipsykotisk behandling (se pkt.
English: CY - Cyprus AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA,
Danish: AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA,
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 skizofreniforsøget 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: On 22 May 2009, the MAH triggered a referral under Article 6(13) of Commission Regulation (EC) No 1084/2003, requesting the CHMP to consider whether it is appropriate to introduce Seroquel XR, at 50 - 300 mg/day dosage 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: Den 22. maj 2009 foretog indehaveren af markedsføringstilladelsen en indbringelse i henhold til artikel 6, stk. 13, i Kommissionens forordning (EF) nr. 1084/2003, og anmodede CHMP om at overveje, om det er hensigtsmæssigt at medtage Seroquel XR med en dosis på 50-300 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: 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 maniforsøget 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: C/ Serrano Galvache, 56Edificio Roble 28033 Madrid Spain
Danish: C/ Serrano Galvache, 56 - Edificio Roble
English: High blood pressure medicines.
Danish: Lægemidler mod forhøjet blodtryk.
English: Cellulose, microcrystalline
Danish: Cellulose, mikrokrystallinsk Natriumcitrat
English: In a short-term placebo-controlled monotherapy trial with Seroquel in adolescent patients (13-17 years of age) with schizophrenia, the aggregated incidence of extrapyramidal symptoms was 12.9% for quetiapine and 5.3% for placebo, though the incidence of the individual adverse events (e.g. akathisia, tremor, extrapyramidal disorder, hypokinesia, restlessness, psychomotor hyperactivity, muscle rigidity, dyskinesia) did not exceed 4.1% in any treatment group.
Danish: I et korttids placebo-kontrolleret monoterapiforsøg med Seroquel med unge patienter (13-17 år) med skizofreni var den samlede forekomst af ekstrapyramidale symptomer 12,9 % for quetiapin og 5,3 % for placebo, selvom forekomsten af de enkelte bivirkninger (f.eks. akatisi, tremor, ekstrapyramidal lidelse, hypokinesi, rastløshed, psykomotorisk hyperaktivitet, muskelstivhed, dyskinesi) ikke oversteg 4,1 % i nogen behandlingsgruppe.
English: Metabolism and nutritional disorders Very common:
Danish: Metabolisme og ernæring Meget almindelig:
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 clearence af quetiapin på omkring 70%.