FrancophonIA/ELRC3.0 huggingface dataset:
English: The patients in these trials died from a variety of causes that were consistent with expectations for this population.
Danish: Patienterne i disse forsøg døde af en række forskellige årsager, som var i henhold til det forventede i denne population.
English: (5) Exacerbation of pre-existing diabetes has been reported in very rare cases.
Danish: (5) Forværring af eksisterende diabetes er rapporteret i meget sjældne tilfælde.
English: Close medical supervision and monitoring should be continued until the patient recovers.
Danish: Tæt overvågning og monitorering bør fortsætte, indtil patienten kommer sig.
English: You have low blood pressure.
Danish: - du har lavt blodtryk.
English: W1K 1LN, UK
Danish: W1K 1LN, Storbritannien
English: You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
Danish: - du ved, at du tidligere har haft et lavt antal hvide blodlegemer (som måske eller måske ikke har været forårsaget af andre lægemidler).
English: • A long-lasting and painful erection (priapism).
Danish: • En langvarig og smertefuld erektion (priapismus).
English: However, survival has also been reported following acute overdoses of up to 30 grams.
Danish: Der er dog også rapporteret overlevelse ved akut overdosering med op til 30 gram.
English: You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.
Danish: Det kan være en hjælp at fortælle en slægtning eller en god ven, at du er deprimeret og bede dem læse denne information.
English: It was nevertheless noted that supportive indirect evidence indicates that an effect can be expected after current or earlier failure (insufficient response or intolerance) with one or two antidepressants.
Danish: Det blev dog bemærket, at understøttende indirekte evidens indikerer, at der kan forventes en virkning efter nuværende eller tidligere fiasko (utilstrækkelig respons eller intolerans) med et eller to antidepressive midler.
English: • Swallow your tablets whole with a drink of water.
Danish: - Synk tabletterne hele med et glas vand.
English: • You will take your tablets once a day.
Danish: - Du skal tage tabletten én gang dagligt.
English: You have problems with your liver.
Danish: - du har problemer med leveren.
English: - The Committee considered all the available data submitted on the safety and efficacy of quetiapine.
Danish: - Udvalget tog alle de tilgængelige data i betragtning, der var fremsendt om quetiapins sikkerhed og virkning,
English: Tardive Dyskinesia:
Danish: Tardiv dyskinesi:
English: An updated version of the Risk Management Plan should be submitted by 30th September 2010 in line with the annual submission of the Period Safety Update Report for Seroquel XR and reflecting the above conditions.
Danish: En opdateret udgave af risikostyringsplanen skal fremsendes senest den 30. september 2010 i tråd med den årlige fremsendelse af den periodiske sikkerhedsopdateringsrapport for Seroquel XR og skal afspejle ovenstående betingelser.
English: You or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Danish: - du eller nogen i din familie har haft blodpropper, da denne type medicin har været forbundet med dannelsen af blodpropper.
English: Thus the potential benefit as add-on treatment was considered.
Danish: Den potentielle gavnlige virkning som tillægsbehandling blev således taget i betragtning.
English: Immediate medical treatment may be needed.
Danish: Dette kræver omgående medicinsk behandling.
English: Note: The frequency is consistent to that observed in adults, but irritability might be associated with different clinical implications in children and adolescents as compared to adults.
Danish: Bemærk: Hyppigheden svarer til den, der er set hos voksne, men irritabilitet kan være forbundet med andre kliniske konsekvenser hos børn og unge sammenlignet med voksne.
English: The safety and efficacy of quetiapine during human pregnancy have not yet been established.
Danish: Sikkerheden og effekten af quetiapin under graviditet er endnu ikke fastlagt.
English: Irritability4
Danish: Irritabilitet4
English: In both studies, patients with known lack of response to Seroquel were excluded.
Danish: I begge forsøg blev patienter med kendt manglende respons på Seroquel ekskluderet.
English: ¾Swedish Record Linkage Study (SE-RLS) in accordance with an agreed protocol.
Danish: ¾ Svensk record linkage-undersøgelse (SE-RLS) i henhold til en godkendt protokol.
English: • The active substance is quetiapine.
Danish: • Det aktive stof er quetiapin.
English: Additionally, norequetiapine has high affinity for the norepinephrine transporter (NET).
Danish: Desuden har norquetiapin høj affinitet for noradrenalintransporteren (NET).
English: Children and Adolescents:
Danish: Børn og unge:
English: Distribution: Quetiapine is approximately 83% bound to plasma proteins.
Danish: Distribution: Quetiapin er ca. 83 % bundet til plasmaproteiner.
English: The maintenance dose (daily dose) will depend on your illness and needs but will usually be between 150 mg and 800 mg.
Danish: Vedligeholdelsesdosis (daglig dosis) vil afhænge af din sygdom og dit behov, men vil normalt være mellem 150 mg og 800 mg.
English: A second study did not demonstrate an additive effect at week 6.
Danish: Et andet forsøg viste ikke en additiv effekt ved uge 6.
English: Changes in thyroid function tests have also been observed in children and adolescents.
Danish: Ændringer i thyroidea funktionstest er også blevet observeret hos børn og unge.
English: Angioedema6, Stevens-Johnson syndrome6
Danish: Angioødem6, Stevens-Johnson syndrom6
English: Furthermore, the long-term safety implications of treatment with Seroquel on growth and maturation have not been studied beyond 26 weeks.
Danish: Endvidere er langsigtede sikkerhedskonsekvenser af behandlingen med Seroquel på vækst og modning ikke blevet undersøgt ud over 26 uger.
English: QT Prolongation:
Danish: QT-forlængelse:
English: (2) Somnolence may occur, usually during the first two weeks of treatment and generally resolves with the continued administration of quetiapine.
Danish: (2) Somnolens kan forkomme - oftest i de første 2 uger af behandlingen og ophører normalt ved fortsat administration af quetiapin.
English: Smaller decreases in total T3 and reverse T3 were seen only at higher doses.
Danish: Mindre fald i total T3 og reverse T3 sås kun ved højere doser.
English: Thioridazine (another anti-psychotic medicine).
Danish: Thioridazin (et andet antipsykotika).
English: Formal interaction studies with commonly used cardiovascular medicinal products have not been performed.
Danish: Der er ikke udført formelle interaktionsforsøg med almindeligt anvendte kardiovaskulære lægemidler.
English: Epilepsy medicines (like phenytoin or carbamazepine).
Danish: Epilepsi lægemidler (f.eks. phenytoin eller carbamazepin).
English: ¾Perform new EU Multi-Country Drug Utilisation Study (EU DUS) in accordance with an agreed protocol.
Danish: ¾ Udførelse af ny undersøgelse af lægemiddelanvendelse i flere EU-lande (EU DUS) i henhold til en godkendt protokol.
English: Children and adolescents The same side effects that may occur in adults may also occur in children and adolescents.
Danish: Børn og unge De samme bivirkninger, der indtræder hos voksne, kan også forekomme hos børn og unge.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SEROQUEL XR AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF SEROQUEL XR OG TILKNYTTEDE NAVNE (se bilag I)
English: • Worsening of pre-existing diabetes.
Danish: • Forværring af eksisterende sukkersyge.
English: Most cases of severe neutropenia have occurred within a couple of months of starting therapy with quetiapine.
Danish: De fleste alvorlige neutropenitilfælde er sket inden for et par måneder efter quetiapin behandlingen er startet.
English: Therefore, Seroquel XR should only be used during pregnancy if the benefits justify the potential risks.
Danish: Seroqul Prolong bør derfor kun anvendes under graviditet, hvis fordelene berettiger de potentielle risici.
English: The reduction in total and free T4 was maximal within the first two to four weeks of Seroquel treatment, with no further reduction during long-term treatment.
Danish: Reduktionen i total og fri T4 var højest indenfor de første 2 - 4 uger af Seroquelbehandlingen, uden yderligere reduktion ved længerevarende behandling.
English: This is because the combined effect of Seroquel XR and alcohol can make you sleepy.
Danish: Dette skyldes, at den samlede virkning af Seroquel Prolong og alkohol kan gøre dig søvnig.
English: There are no active controlled on long-term safety data in MDD and the placebo controlled randomised withdrawal data are of limited value due to decreased numbers of patients over time.
Danish: Der er ingen aktivt kontrollerede langsigtede sikkerhedsdata for MDD, og de placebokontrollerede randomiserede tilbagetrækningsdata er af begrænset værdi, fordi antallet af patienter bliver lavere med tiden.
English: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suiciderelated events).
Danish: Depression lidelse er forbundet med en øget risiko for selvmordstanker, selvdestruktiv adfærd og selvmord (selvmordsrelaterede hændelser).
English: Severe Neutropenia:
Danish: Alvorlig neutropeni:
English: In addition, physicians should consider the potential risk of suicide-related events after abrupt cessation of quetiapine treatment, due to the known risk factors for the disease being treated.
Danish: Desuden bør læger overveje den potentielle risiko for selvmordsrelaterede hændelser efter pludseligt ophør af behandling med quetipin, som følge af de kendte risikofaktorer for den behandlede sygdom.
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Danish: Passende klinisk monitorering i overensstemmelse med de gældende retningslinjer for antispykotisk behandling anbefales.
English: This is most likely to occur within the first few weeks of treatment.
Danish: Forekommer hovedsagelig i de første uger af behandlingen.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, decreases in the number of certain types of blood cells 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, fald i mængden af visse typer blodlegemer og stigninger i mængden af hormonet prolaktin i blodet.
English: Whilst the prevention of absorption in overdose has not been investigated, gastric lavage can be indicated in severe poisonings and if possible to perform within one hour of ingestion.
Danish: Selvom hæmning af absorption ved overdosis ikke er undersøgt, kan maveskylning være indiceret ved svære forgiftninger og hvis det er muligt at udføre inden for en time efter indtagelse.
English: Erythromycin or clarithromycin (for infections).
Danish: erythromycin eller clarithromycin (mod infektioner).
English: If you do, your doctor may check your blood sugar levels while you are taking Seroquel XR.
Danish: Hvis dette er tilfældet, kan det være at din læge checker dit blodsukkerniveau, mens du tager Seroquel Prolong.
English: Additional information:
Danish: Yderligere information:
English: A slower titration regimen could be considered in patients with underlying cardiovascular disease.
Danish: Et langsommere doseringsregime kan overvejes til patienter med underliggende kardiovaskulær sygdom.
English: Weight:
Danish: Vægt:
English: However, the committee agreed that long-term safety on add-on treatment is needed when considering the potentially large number of possible combinations and the potential long-term safety concerns identified (i.e. metabolic changes and EPS related events).
Danish: Udvalget besluttede dog, at det er nødvendigt at påvise tillægsbehandlingens sikkerhed på lang sigt i betragtning af det potentielt store antal mulige kombinationer og de potentielle betænkeligheder med hensyn til sikkerheden på lang sigt (nemlig metaboliske ændringer og EPS-relaterede begivenheder).
English: The need to increase the dose from 150 to 300 mg/day should be based on individual patient evaluation.
Danish: Behovet for at øge dosis fra 150 til 300 mg daglig skal baseres på en individuel evaluering af patienten.
English: Seroquel XR can be used to treat several illnesses, such as:
Danish: Seroquel Prolong kan bruges til at behandle forskellige sygdomme, som f.eks.:
English: In post marketing experience, there have been very rare reports of overdose of quetiapine alone resulting in death or coma or QT-prolongation.
Danish: Efter markedsføring har der været meget få rapporter med overdosering af quetiapin alene, der førte til død, koma eller QT-forlængelse.
English: Barbiturates (for difficulty sleeping).
Danish: Barbiturater (mod søvnbesvær).
English: feeling restless or muscle stiffness without pain.
Danish: rastløshed eller muskelstivhed uden smerte.
English: This includes medicines that you buy without a prescription and herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept og naturmedicin.
English: This increase in clearance reduced systemic quetiapine exposure (as measured by AUC) to an average of 13% of the exposure during administration of quetiapine alone; although a greater effect was seen in some patients.
Danish: Denne øgede clearence reducerede den systemiske eksponering af quetiapin (målt som AUC) til gennemsnitlig 13% af eksponeringen ved quetiapin alene, selvom en større effekt blev observeret hos nogle patienter.
English: As a consequence of this interaction, lower plasma concentrations can occur, which could affect the efficacy of Seroquel XR therapy.
Danish: Som en konsekvens af denne interaktion, kan lavere plasmakoncentrationer forekomme, hvilket kan påvirke effekten af Seroquel Prolong.
English: Hyperglycaemia:
Danish: Hyperglykæmi:
English: AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands
Danish: AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer Holland
English: You have diabetes or have a risk of getting diabetes.
Danish: - du har sukkersyge, eller har risiko for at få det.
English: Suicide/suicidal thoughts or clinical worsening:
Danish: Selvmord/selvmordstanker eller klinisk forværring:
English: These data do not establish a causal relationship between quetiapine treatment and death in elderly patients with dementia.
Danish: Disse data viser ikke en kausal sammenhæng mellem quetiapin behandling og død hos ældre demenspatienter.
English: The target population have not been studied in the placebo controlled monotherapy studies and the potential better safety profile of alternative antidepressants precluded a positive balance between efficacy and safety in the claimed indication.
Danish: Målpopulationen var ikke blevet undersøgt i de placebokontrollerede monoterapiundersøgelser, og de alternative antidepressivas potentielle bedre sikkerhedsprofil udelukker en positiv balance mellem virkning og sikkerhed i den indikation, der ansøges om.
English: Two short-term (6 week) studies enrolled patients who had shown an inadequate response to at least one antidepressant.
Danish: To korttidsforsøg (6 uger) indrullerede patienter, som havde vist utilstrækkeligt respons på mindst et antidepressivum.
English: Nonetheless, the CHMP noted that the pattern of adverse events in the randomised phase of this stidy was similar to that seen in the short-term studies.
Danish: CHMP bemærkede dog, at mønsteret for utilsigtede hændelser i den randomiserede fase af denne undersøgelse lignede mønsteret i undersøgelserne af den kortsigtede virkning.
English: Quetiapine treatment was associated with small dose-related decreases in thyroid hormone levels, particularly total T4 and free T4.
Danish: Behandling med quetiapin er blevet sat i forbindelse med små dosisrelaterede fald i thyreoideahormonniveauer, især total T4 og fri T4.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: • Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed
Danish: • Skizofreni: Du kan høre eller fornemme ting, som ikke er der, tro på ting, der ikke er sande, eller føle dig usædvanligt mistroisk, nervøs, forvirret, have skyldfølelse, være anspændt eller deprimeret.
English: Steadystate peak molar concentrations of the active metabolite norquetiapine are 35% of that observed for quetiapine.
Danish: Steady-state peak molære koncentrationer af den aktive metabolit norquetiapin er 35 % af den, der er set for quetiapin.
English: Hyperprolactinemia16
Danish: Hyperprolaktinæmi16
English: Eosinophilia, Thrombocytopenia
Danish: Eosinofili, thrombocytopeni
English: Possible risk factors for neutropenia include pre-existing low white cell count (WBC) and history of drug induced neutropenia.
Danish: Mulige neutropeni risikofaktorer er et eksisterende lavt antal hvide blodlegemer (WBC) og tidligere medicininduceret neutropeni.
English: Patients should be observed for signs and symptoms of infection and neutrophil counts followed (until they exceed 1.5 X 109/L).
Danish: Patienterne skal observeres med hensyn til tegn og symptomer på infektion og neutrofiltallet skal følges (indtil det overstiger <1,5 x 109/l).
English: The safety profile in the MDD population was shown consistent with the already known safety profile of quetiapine in other indications.
Danish: Det blev påvist, at sikkerhedsprofilen hos MDD-populationen var i overensstemmelse med quetiapins velkendte sikkerhedsprofil i andre indikationer.
English: Priapism, Galactorrhoea
Danish: Priapismus, galaktoré
English: Venous Thromboembolism (VTE):
Danish: Venøs tromboemboli (VTE):
English: Following pregnancies in which quetiapine was used, neonatal withdrawal symptoms were observed.
Danish: Efter graviditeter, hvorunder quetiapin var anvendt, blev der observeret seponeringssymptomer hos nyfødte.
English: Constipation, dyspepsia
Danish: Forstoppelse, dyspepsi
English: It also blocks the action of dopamine agonists, measured either behaviourally or electrophysiologically, and elevates dopamine metabolite concentrations, a neurochemical index of D2-receptor blockade.
Danish: Det blokerer også virkningen af dopaminagonister, enten målt adfærdsmæssigt eller elektrofysiologisk og forhøjer dopamins metabolitkoncentrationer, et neurokemisk udtryk for D2 receptor blokering.
English: The incidences of ADRs associated with quetiapine therapy, are tabulated below according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group 1995).
Danish: Forekomsten af bivirkninger i forbindelse med quetiapin behandling er gengivet nedenfor i tabelformat som anbefalet af Council for International Organizations of Medical Sciences (CIOMS III Working Group; 1995)
English: Approximately 73% of a radiolabelled drug was excreted in the urine and 21% in the faeces with less than 5% of the total radioactivity representing unchanged drug-related material.
Danish: Ca. 73 % af det radioaktivt mærkede stof blev udskilt i urinen og 21 % i afføringen med mindre end 5% af den totale radioaktivitet stammende fra uomdannet lægemiddel-relateret stof.
English: (3) Asymptomatic elevations in serum transaminase (ALT, AST) or gamma-GT-levels have been observed in some patients administered quetiapine.
Danish: (3) Asymptomatiske stigninger i serumtransaminaser (ALT, AST) eller gamma-GT niveauer er observeret hos nogle patienter i quetiapinbehandling.
English: The AUC and Cmax for the active metabolite, norquetiapine, were higher, approximately 62% and 49% in children (10-12 years), respectively and 28% and 14% in adolescents (13-17 years), respectively, compared to adults.
Danish: AUC og Cmax for den aktive metabolit, norquetiapin, var højere, ca. hhv. 62 % og 49% hos børn (10-12 år) og hhv. 28 % og 14 % hos unge (13-17 år) sammenlignet med voksne.
English: The pharmacokinetics of quetiapine and norquetiapine are linear and dose-proportional for doses up to 800 mg administered once daily.
Danish: Farmakokinetikken af quetiapin og norquetiapin er lineær og proportional med dosis for doser op til 800 mg administreret én gang dagligt.
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: Special populations
Danish: Særlige grupper
English: Mean change among patients who had this increase was 41.7 mg/dL ( 1.07 mmol/L).
Danish: Gennemsnitsændringen blandt patienter med denne stigning var 41,7 mg/dl (≥1,07 mmol/l).
English: • Women to have no monthly period or irregular periods.
Danish: Kvinder kan få manglende eller uregelmæssig menstruation.
English: Neutropenia 1
Danish: Neutropeni1
English: Fatal outcome has been reported in clinical trials following an acute overdose at 13.6 grams, and in post-marketing on doses as low as 6 grams of Seroquel alone.
Danish: I kliniske forsøg er der rapporteret dødsfald efter en akut overdosering med 13,6 gram og efter markedsføring ved doser så lavt som 6 gram Seroquel alene.
English: • Abnormal muscle movements.
Danish: • Ufrivillige muskelbevægelser.
English: In a specific interaction study in psychotic patients, however, no increase in the cytochrome P450 activity was found after administration of quetiapine.
Danish: I et specifikt interaktionsforøg hos psykotiske patienter sås dog ingen stigning i cytochrom P450 aktiviteten efter administration af quetiapin.
English: When adjusting for normal growth over longer term, an increase of at least 0.5 standard deviation from baseline in Body Mass Index (BMI) was used as a measure of a clinically significant change; 18.3% of patients who were treated with quetiapine for at least 26 weeks met this criterion.
Danish: Ved justering for normal vækst over længere tid blev en stigning på mindst 0,5 standard afvigelse fra baseline i Body Mass Index (BMI) anvendt som et mål for en klinisk signifikant ændring; 18,3 % af patienter, som blev behandlet med quetiapin i mindst 26 uger, opfyldte dette kriterium.
English: • Inflammation of the liver (hepatitis)
Danish: • Leverbetændelse (hepatitis).
English: AT - Austria AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien
Danish: AstraZeneca Österreich GmbH Schwarzenbergplatz 7 A-1037 Wien
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 clearence af quetiapin hos ældre er ca. 30 til 50 % lavere end hos voksne mellem 18 og 65 år.
English: The primary outcome variable in the placebo-controlled trial was change from baseline to final assessment in the PANSS total score.
Danish: Primær effektparameter i det placebo-kontrollerede forsøg var ændring i PANSS total fra baseline til endelig evaluering.
English: The CHMP agreed that the potential long-term safety concerns could be manageable by updated warnings in the product information and by collection of data in the already ongoing and in new post authorisation safety studies (PASSs) which will be included in the updated Risk Management Plan.
Danish: CHMP besluttede, at de potentielle betænkeligheder med hensyn til sikkerheden på lang sigt kunne håndteres ved hjælp af opdaterede advarsler i produktinformationen og ved at indsamle data i de allerede igangværende og de nye sikkerhedsundersøgelser efter godkendelsen (PASS), som vil blive medtaget i den opdaterede risikostyringsplan.