FrancophonIA/ELRC3.0 huggingface dataset:
English: Possible risk factors for neutropenia include pre-existing low white blood cell count (WBC) and history of drug induced neutropenia.
Danish: Mulige risikofaktorer for neutropenu er eksisterende lavt antal hvide blodlegemer (WBC) og tidligere medicininduceret neutropeni.
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 studie.
English: • Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
Danish: • Pludselig hævelse af huden, som regel omkring øjnene, læber og hals (angioødem).
English: • Dizziness (may lead to falls), headache, dry mouth.
Danish: • Svimmelhed (kan medføre fald), hovedpine, tør mund.
English: In general, reported signs and symptoms were those resulting from an exaggeration of the active substance's known pharmacological effects, ie, drowsiness and sedation, tachycardia and hypotension.
Danish: Generelt var de rapporterede tegn og symptomer resultatet af en forstærkning af det aktive stofs kendte farmakologiske effekter dvs. søvnighed og sedation, takykardi og hypotension.
English: Inappropriate antidiuretic hormone secretion
Danish: Uhensigtsmæs sig produktion af antidiuretisk hormon
English: • Decreases in the number of certain types of blood cells
Danish: • Nedsat antal af visse typer blodlegemer.
English: Metabolic syndrome29
Danish: Metabolisk syndrom 29
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: Pharmacotherapeutic group: Antipsychotics ATC code: N05A H04
Danish: Farmakoterapeutisk gruppe: Antipsykotika ATC-kode: N 05 AH 04
English: Shifts in total T4, free T4, total T3 and free T3 are defined as <0.8 x LLN (pmol/L) and shift in TSH is > 5 mIU/L at any time.
Danish: Ændringer i total T4, fri T4, total T3 og fri T3 defineres som <0,8 x LLN (pmol/L) og ændringer i TSH er > 5 mIU/l når som helst.
English: The recommended daily dose is 300 mg.
Danish: Den anbefalede dosis er 300 mg dagligt.
English: In a fertility study in rats, marginal reduction in male fertility and pseudopregnancy, protracted periods of diestrus, increased precoital interval and reduced pregnancy rate were seen.
Danish: I et fertilitetsstudie hos rotter så man marginal reduktion i fertilitet hos hanrotter og pseudodrægtighed, langvarige perioder med diestrus, øget precoital interval og nedsat drægtighedsrate.
English: The elimination half lives of quetiapine and norquetiapine are approximately 7 and 12 hours, respectively.
Danish: Halveringstiden for eliminering af quetiapin og norquetiapin er henholdsvis ca. 7 og 12 timer.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest revideret {MM/ÅÅÅÅ}.
English: Seroquel compresse a rilascio prolungato
Danish: Seroquel compresse a rilascio prolungato: Italien.
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 clearance reducerede den systemiske eksponering af quetiapin (målt som AUC) til gennemsnitlig 13 % af eksponeringen ved quetiapin administreret alene, selvom en større effekt blev observeret hos nogle patienter.
English: • Increased appetite
Danish: • Øget appetit
English: The incidence of reciprocal, potentially clinically significant shifts of both T3 or T4 and TSH in these trials were rare, and the observed changes in thyroid hormone levels were not associated with clinically symptomatic hypothyroidism.
Danish: Hyppigheden af gensidige, potentielt klinisk signifikante ændringer i både T3 eller T4 og TSH i disse studier var sjældne, og de observerede ændringer i thyroideahormon-niveauerne var ikke forbundne med klinisk symptomatisk hypothyroidisme.
English: When Seroquel XR is compared to Seroquel immediate release, the norquetiapine metabolite AUC is 18% lower.
Danish: Når Seroquel Prolong sammenlignes med Seroquel tabletter er AUC for norquetiapin metabolitten 18 % lavere.
English: • Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
Danish: • Overfølsomhedsreaktioner, der kan omfatte hævede knuder (kvadler), hævelse af huden og hævelse omkring munden.
English: Priapism, galactorrhoea, breast swelling, menstrual disorder
Danish: Priapisme, galaktorré, brysthævelse, menstruations forstyrrelser
English: The estimated risks of relapse after 6 months treatments was 14.3% for the Seroquel XR treatment group compared to 68.2% for placebo.
Danish: Den estimerede risiko for tilbagefald efter 6 måneders behandling var 14,3 % for Seroquel Prolong-behandlingsgruppen sammenlignet med 68,2 % for placebo.
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: The mean dose of Seroquel XR during the randomised phase was 177 mg/day.
Danish: Gennemsnitsdosis for Seroquel Prolong i den randomiserede fase var 177 mg/dag.
English: • Thioridazine or Lithium (other anti-psychotic medicines).
Danish: • Thioridazin eller lithium (andre antipsykotika).
English: Angioedema5, StevensJohnson syndrome
Danish: Angioødem5, StevensJohnsons syndrom
English: Given the observed risk for worsening of their metabolic profile, including changes in weight, blood glucose (see hyperglycemia) and lipids, which was seen in clinical studies, patients' metabolic parameters should be assessed at the time of treatment initiation and changes in these parameters should be regularly controlled for during the course of treatment.
Danish: På baggrund af den observerede risiko for forværring af patientens metaboliske profil, herunder ændringer i vægt, blodglucose (se hyperglykæmi) og lipider, der blev set i kliniske studier, skal de metaboliske parametre vurderes ved behandlingsstart, og der skal regelmæssigt kontrolleres for ændringer i disse parametre under behandlingen.
English: • Symptoms of withdrawal may occur in newborn babies of mothers that have used Seroquel during their pregnancy.
Danish: • Abstinenssymptomer kan forekomme hos nyfødte, hvor mødrene har anvendt Seroquel under graviditeten.
English: Anaphylactic reaction5
Danish: Anafylaktisk reaktion5
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 D2receptorblokering.
English: Quetiapine produces only weak catalepsy at effective dopamine D2-receptor blocking doses.
Danish: Quetiapin forårsager kun svag katalepsi ved effektive dopamin D2-receptorblokerende doser.
English: For the treatment of schizophrenia, Seroquel should be administered twice a day.
Danish: Til behandling af skizofreni bør Seroquel tages to gange dagligt.
English: For 150 mg and 300 mg tablets pack sizes of 120, 180 and 240 tablets are registered.
Danish: For 150 mg og 300 mg er der registreret pakningsstørrelser på 120, 180 og 240 tabletter.
English: Elderly people If you are elderly your doctor may change your dose.
Danish: Ældre Din læge vil muligvis ændre din dosis, hvis du er en ældre person.
English: Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression.
Danish: Information fra kliniske studier viser, at der er en øget risiko for selvmordstanker og/eller selvmordsadfærd hos yngre voksne under 25 år med depression.
English: • Yellowing of the skin and eyes (jaundice).
Danish: • Gulfarvning af hud og øjne (gulsot).
English: Therefore, patients should be advised not to drive or operate machinery, until individual susceptibility to this is known.
Danish: Derfor bør patienter advares mod at køre bil og betjene maskiner, indtil den enkeltes påvirkelighed er kendt.
English: Based on public literature, patients with delerium and agitation and a clear anticholinergic syndrome may be treated with physostigmine, 1-2 mg (under continuous ECG monitoring).
Danish: Baseret på publiceret litteratur kan patienter med delirium og agitation samt et tydeligt antikolinergt syndrom behandles med 1-2 mg physostigmin under kontinuerligt EKG monitorering.
English: The incidences of shifts in TSH was 3.2 % for quetiapine versus 2.7 % for placebo.
Danish: Hyppigheden af ændringer i TSH var 3,2 % for quetiapin over for 2,7 % for placebo.
English: Quetiapine should be used with caution in patients with known cardiovascular disease, cerebrovascular disease, or other conditions predisposing to hypotension.
Danish: Quetiapin bør anvendes med forsigtighed til patienter med kendt kardiovaskulær sygdom, cerebrovaskulær sygdom eller andre tilstande, hvor patienten er disponeret for hypotension.
English: Patients 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 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 nødvendigt at overveje seponering.
English: The maintenance dose (daily dose) will depend on your illness and needs but will usually be between 150 mg and 800 mg.
Danish: Din læge vil bestemme hvilken dosering, du skal starte med. Vedligeholdelsesdosis (daglig dosis) vil afhænge af din sygdom og dit behov, men vil normalt være mellem 150 mg og 800 mg.
English: Lipid changes should be managed as clinically appropriate.
Danish: Lipidændringer skal håndteres i henhold til normal klinisk praksis.
English: Patients treated with any antipsychotic agent including quetiapine, should be observed for signs and symptoms of hyperglycaemia, (such as polydipsia, polyuria, polyphagia and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Danish: Patienter, der behandles med antipsykotisk medicin, herunder quetiapin, bør observeres for tegn og symptomer på hyperglykæmi (såsom polydipsi, polyuri, polyfagi og svækkelse), og patienter med diabetes mellitus eller risikofaktorer for diabetes mellitus bør monitoreres regelmæssigt for dårligere glucosekontrol.
English: Quetiapine and the active human plasma metabolite, norquetiapine interact with a broad range of neurotransmitter receptors.
Danish: Quetiapin og den aktive humane plasma metabolit, norquetiapin indvirker på en bred vifte af neurotransmitterreceptorer.
English: The number of patients with a mood event was 91 (22.5%) in the quetiapine group, 208 (51.5%) in the placebo group and 95 (26.1%) in the lithium treatment groups respectively.
Danish: Antallet af patienter med en stemningshændelse var henholdsvis 91 (22,5 %) i quetiapingruppen, 208 (51,5 %) i placebogruppen og 95 (26,1 %) i de lithiumbehandlede grupper.
English: Adults:
Danish: Voksne
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
Danish: ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR
English: The symptoms of tardive dyskinesia can worsen or even arise after discontinuation of treatment (see Section 4.8).
Danish: Symptomer på tardiv dyskinesi kan forværres eller endda opstå efter behandlingsophør (se pkt.
English: The incidence of relapse was 14.2% for Seroquel XR treated patients and 34.4% for placebo-treated patients.
Danish: Recidivhyppigheden var 14,2 % for Seroquel Prolong-behandlede patienter og 34,4 % for placebo-behandlede patienter.
English: Epinephrine and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of quetiapine-induced alpha blockade.
Danish: Epinefrin og dopamin skal undgås, da betastimulering kan forværre hypotension i et regi med en quetiapin-fremkaldt alfablokade.
English: Quetiapine demonstrates selectivity for the limbic system by producing depolarisation blockade of the mesolimbic but not the nigrostriatal dopamine-containing neurones following chronic administration.
Danish: Quetiapin udviser ved kronisk administrering selektivitet for det limbiske system, idet der forekommer en depolariserende blokade af de mesolimbiske, men ikke af de nigrostriatale dopamin-holdige neuroner.
English: In addition, a higher percentage of patients treated in the lithium add-on group (8.0%) had weight gain (≥7%) at the end of treatment compared to patients in the placebo add-on group (4.7%).
Danish: Derudover oplevede en højere procentdel af de patienter, der blev behandlet i gruppen med lithium som tillægsbehandling (8,0 %) vægtøgning (≥7 %) ved afslutning af behandlingen sammenlignet med patienterne i gruppen med placebo som tillægsbehandling (4,7 %).
English: In an embryofetal toxicity study in rabbits the foetal incidence of carpal/tarsal flexure was increased.
Danish: I et embryoføtal toksicitetsstudie hos kaniner var den føtale incidens af carpal/tarsal bøjning øget.
English: Elevations in serum triglyceride levels 10,30
Danish: Stigning i serumtriglycer ider 10,30
English: Quetiapine and norquetiapine have no appreciable affinity at benzodiazepine receptors but high affinity at histaminergic and adrenergic alpha1 receptors, moderate affinity at adrenergic alpha2 receptors and moderate to high affinity at several muscarinic receptors.
Danish: Quetiapin og norquetiapin har ingen væsentlig affinitet til benzodiazepinreceptorer, men høj affinitet til histaminerge og adrenerge alfa1-receptorer, moderat affinitet til adrenerge alfa2receptorer og moderat til høj affinitet til adskillige muskarinreceptorer.
English: Quetiapine is well absorbed and extensively metabolised following oral administration.
Danish: Quetiapin bliver velabsorberet og metaboliseres i udstrakt grad efter oral administration.
English: Caution should be exercised when quetiapine is used concomitantly with medicinal products known to cause electrolyte imbalance or to increase QT interval.
Danish: Der bør udvises forsigtighed, når quetiapin anvendes samtidig med lægemidler, som er kendt for at medføre elektrolyt ubalance eller øge QT-intervallet.
English: • Feeling sleepy (this may go away with time, as you keep taking Seroquel) (may lead to falls).
Danish: • Søvnighed (forsvinder oftest med tiden, når du fortsætter med at tage Seroquel) (kan medføre fald).
English: • Change in electrical activity of the heart seen on ECG (QT prolongation)
Danish: • Ændring af hjertets elektriske impulser, set på hjertekardiogram (forlængelse af QT-intervallet).
English: A placebo-controlled trial evaluating fixed doses of quetiapine across the range of 75 to 750 mg/day showed no evidence of an increase in EPS or the use of concomitant anticholinergics.
Danish: Et placebo-kontrolleret studie, som undersøgte fastsatte doser af quetiapin i intervallet 75-750 mg/dag, viste ingen tegn på en stigning i EPS eller samtidig anvendelse af anticholinerge stoffer.
English: In a third short-term placebo-controlled monotherapy trial with Seroquel XR in children and adolescent patients (10-17 years of age) with bipolar depression, efficacy was not demonstrated.
Danish: I et tredje kortvarigt placebokontrolleret monoterapistudie med Seroquel Prolong til børn og unge patienter (10-17 år) med bipolar depression blev der ikke påvist nogen effekt.
English: Quetiapine is extensively metabolised by the liver, with parent compound accounting for less than 5% of unchanged drug-related material in the urine or faeces, following the administration of radiolabelled quetiapine.
Danish: Quetiapin metaboliseres i vid udstrækning i leveren, hvor umetaboliseret quetiapin udgør mindre end 5 % af uomdannet lægemiddel-relateret stof i urinen eller afføringen efter indgift af radioaktivt mærket quetiapin.
English: In cases of severe signs, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.
Danish: Intensiv behandling anbefales, deriblandt sikring og vedligeholdelse af åbne luftveje, sikring af tilstrækkelig ilttilførsel og ventilation, samt overvågning og understøttelse af det kardiovaskulære system.
English: During an extended post-treatment follow-up phase of the bipolar depression trial, there were two additional suicide related events in two patients; one of these patients was on quetiapine at the time of the event.
Danish: I løbet af en udvidet opfølgende postbehandlingsfase i studiet med bipolar depression, var der yderligere to selvmordsrelaterede hændelser hos to patienter; en af disse patienter var i behandling med quetiapin på tidspunktet for hændelsen.
English: Do not take Seroquel if the above applies to you.
Danish: Tag ikke Seroquel hvis ovenstående gælder for dig.
English: In cases of quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents.
Danish: I tilfælde af en quetiapin-overdosis skal refraktær hypotension behandles efter standardforskrifter, herunder med intravenøs væske og/eller sympatomimetika.
English: The lowest effective dose, starting from 50 mg/day should be used.
Danish: Den laveste effektive dosis, startende med 50 mg/dag, skal anvendes.
English: Pharmacokinetic data were sampled in 9 children aged 10-12 years old and 12 adolescents, who were on steady-state treatment with 400 mg quetiapine twice daily.
Danish: Farmakokinetiske data blev undersøgt hos 9 børn i alderen 10-12 år og 12 unge, som var på steadystate-behandling med 400 mg quetiapin to gange daglig.
English: Jaundice5 Hepatitis
Danish: Gulsot5, hepatitis
English: The usual effective dose is in the range of 400 to 800 mg/day.
Danish: Normal effektiv dosis er i intervallet 400-800 mg/dag.
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 demensrelateret psykose er i øget risiko for at dø sammenlignet med placebo.
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: (23) These reports often occurred in the setting of tachycardia, dizziness, orthostatic hypotension, and/or underlying cardiac/respiratory disease.
Danish: (23) Disse indberetninger optrådte hyppigt sammen med takykardi, svimmelhed, ortostatisk hypotension og/eller underliggende hjerte-/åndedrætssygdomme.
English: When Seroquel XR administered once daily is compared to the same total daily dose of immediate-release quetiapine fumarate (Seroquel immediate release) administered twice daily, the area under the plasma concentration-time curve (AUC) is equivalent, but the maximum plasma concentration (Cmax) is 13% lower at steady state.
Danish: Når Seroquel Prolong administreret en gang daglig sammenlignes med den samme totale daglige dosis af quetiapinfumarat givet som Seroquel tabletter to gange daglig, er arealet under plasma koncentration-tids kurven (AUC) ækvivalent, men den maksimale plasmakoncentration (Cmax) er 13 % lavere.
English: • Seroquel can be taken with or without food.
Danish: • Seroquel kan tages med eller uden samtidig fødeindtagelse.
English: MARKETING AUTHORISATION NUMBER(S) <[To be completed nationally]>
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) <[Udfyldes nationalt]>
English: Based on these in vitro results, it is unlikely that co-administration 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: With respect to weight gain, when adjusting for normal growth over the 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: Med hensyn til vægtøgning blev der anvendt en stigning på mindst 0,5 standardafvigelse fra baseline i Body Mass Index (BMI), med justering for normal vækst over længere tid, som mål for klinisk signifikant ændring; 18,3 % af patienterne, som blev behandlet med quetiapin i mindst 26 uger, opfyldte dette kriterium.
English: (1) See Section 4.4.
Danish: (1) Se pkt 4.4.
English: On the basis of this, concomitant use of quetiapine with CYP3A4inhibitors is contraindicated.
Danish: På baggrund heraf er samtidig brug af quetiapin og CYP3A4-inhibitorer kontraindiceret.
English: 6 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Danish: 6 filmovertrukne tabletter 20 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 60 filmovertrukne tabletter 100 filmovertrukne tabletter
English: The following table summarises ADRs that occur in a higher frequency category in children and adolescents patients (10-17 years of age) than in the adult population or ADRs that have not been identified in the adult population.
Danish: Følgende tabel opsummerer bivirkninger, som indtræder med større hyppighed hos børn og unge patienter (10-17 år) end hos voksenpopulationen, eller bivirkninger, som ikke er blevet identificeret hos voksenpopulationen.
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: 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 studier har indikeret, at ved mistanke om toleransudvikling hos enkelte patienter kan en reduktion af dosis til minimum 200 mg overvejes.
English: Venous Thromboembolism (VTE)
Danish: Venøs tromboemboli (VTE)
English: • Inflammation of the liver (hepatitis).
Danish: • Leverbetændelse (hepatitis).
English: • Feeling like your heart is pounding, racing or has skipped beats.
Danish: • Fornemmelse af, at hjertet banker, slår hurtigt eller springer slag over.
English: Increased appetite, blood glucose increased to hyperglycaemic levels 6, 30
Danish: Øget appetit, blodglucosesti gning til hyperglykæmi sk niveau 6,30
English: The incidence of these reactions had decreased significantly after 1 week post-discontinuation.
Danish: Hyppigheden faldt signifikant 1 uge efter seponering.
English: The average molar dose fraction of free quetiapine and the active human plasma metabolite norquetiapine is <5% excreted in the urine.
Danish: Den gennemsnitlige molære dosisfraktion af fri quetiapin og den aktive humane plasmametabolit norquetiapin er <5 % udskilt i urinen.