natgillin/translations-raw huggingface dataset:
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 %.
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.
Brug ikke Seroquel Prolong efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen (EXP) er den sidste dag i den nævnte måned.
• Do not use Seroquel XR after the expiry date which is stated on the container after EXP.
Effekten på PANSS total var numerisk større for 600 mg og 800 mg end for 400 mg.
The effect size of the 600 mg and 800 mg doses was greater than that of the 400 mg dose.
Tag altid Seroquel Prolong efter lægens anvisning.
Always take Seroquel XR exactly as your doctor has told you.
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.
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.
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.
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.
Der kan være problemer med at få gang i musklerne, rysten,
These include difficulty starting muscle movements, shaking,
Forhøjede serumtriglyceridniveauer11
Investigations Very common Elevations in serum triglyceride levels 11
Hvis du er deprimeret, kan det være, at du ind imellem tænker på at skade dig selv eller begå selvmord.
Thoughts of suicide and worsening of your depression If you are depressed you may sometimes have thoughts of harming or killing yourself.
Stigninger i mængden af hormonet prolaktin i blodet.
• Increase in the amount of a hormone called prolactin, in the blood.
- Selvom du får det bedre, må du ikke stoppe med at tage tabletterne, uden at have talt med din læge.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you.
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.
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.
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.
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).
BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ OG INDLÆGSSEDDEL
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, AND PACKAGE LEAFLET
Quetiapin blev i kliniske forsøg og ved anvendelse i henhold til produktresuméet ikke forbundet med vedvarende forlængelse af QT-intervaller.
In clinical trials and use in accordance with the SPC, quetiapine was not associated with a persistent increase in absolute QT intervals.
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).
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.
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).
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).
¾ M-PEM-undersøgelse (ændret overvågning af behandlingsforløb), ¾ GPRD-undersøgelse (General Practice Research Database).
¾ General Practice Research Database (GPRD) Study;
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 %).
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).
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.
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.
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.
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.
Skift fra Seroqueltabletter:
Switching from Seroquel immediate-release tablets:
Din læge vil muligvis ændre din dosis, hvis du er en ældre person.
Elderly people If you are elderly your doctor may change your dose.
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Diabetes mellitus1,5,6
Diabetes Mellitus 1,5,6, Psychiatric disorders Common:
Metabolisme og ernæring: Almindelig:
Metabolism and nutritional disorders Common:
Farmakoterapeutisk klassifikation: Antipsykotika; diazepiner, oxazepiner og thiazepiner.
Pharmacotherapeutic group: Antipsychotics; Diazepines, oxazepines and thiazepines ATC code: N05A H04
I placebo-kontrollerede kliniske forsøg med børn og unge patienter behandlet med Seroquel er quetiapin blevet forbundet med en øget forekomst af ekstrapyramidale symptomer (EPS) sammenlignet med placebo hos patienter behandlet for skizofreni og bipolar mani (se pkt.
In placebo-controlled clinical trials with children and adolescent patients treated with Seroquel, quetiapine was associated with an increased incidence of extrapyramidal symptoms (EPS) compared to placebo in patients treated for schizophrenia and bipolar mania (see section 4.8).
• Seponeringssymptomer (symptomer som forekommer, når du stopper med at tage Seroquel Prolong) inkluderer søvnløshed, kvalme, hovedpine, diarré, opkastning, svimmelhed og irritabilitet.
• Discontinuation symptoms (symptoms which occur when you stop taking Seroquel XR) include not being able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea, being sick
Ved kronisk administrering forårsager quetiapin ikke supersensitivitet overfor dopamin D2 receptorer.
Quetiapine does not produce dopamine D2-receptor supersensitivity after chronic administration.
BILAG III PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
I to monoterapiforsøg med behandling af moderate til svære maniske episoder har Seroquel vist bedre effekt end placebo på reduktion af maniske symptomer ved uge 3 og 12.
In the treatment of moderate to severe manic episodes, Seroquel demonstrated superior efficacy to placebo in reduction of manic symptoms at 3 and 12 weeks, in two monotherapy trials.
I et klinisk forsøg i bipolar I og bipolar II lidelse hos patienter med depressive episoder viste Seroquel Prolong 300 mg/dag bedre effekt end placebo i reduktion af MADRS totalscore.
In a clinical trial, in patients with depressive episodes in bipolar I or bipolar II disorder, 300 mg/day Seroquel XR showed superior efficacy to placebo in reduction of MADRS total score.
Efter markedsføring er der rapporteret QT-forlængelse for quetiapin ved de terapeutiske doser (se pkt.
In post marketing, QT prolongation was reported with quetiapine at the therapeutic doses (see Section 4.8) and in overdose (see Section 4.9).
I korttidsforsøg blev den antidepressive virkning observeret ved 150 og 300 mg daglig, når lægemidlet blev givet som supplerende behandling (i kombination med amitriptylin, bupropion, citalopram, duloxetin, escitalopram, fluoxetin, paroxetin, sertralin og venlafaxin - se pkt.
Antidepressant effect was seen at 150 and 300 mg/day in short-term trials as add-on therapy (with amitriptyline, bupropion, citalopram, duloxetine, escitalopram, fluoxetine, paroxetine, sertraline and venlafaxine - see Section 5.1) and at 50 mg/day in short-term monotherapy trials.
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Kliniske forsøg med patienter med unipolar depression viste, at hyppigheden af selvmordsrelaterede hændelser hos unge voksne patienter (yngre end 25 år) var 2,1 % (3/144) for quetiapin og 1,3 % (1/75) for placebo.
In clinical studies of patients with MDD the incidence of suicide-related events observed in young adult patients (younger than 25 years of age) was 2.1% (3/144) for quetiapine and 1.3% (1/75) for placebo.
Seroquel Prolong er indiceret til:
Seroquel XR is indicated for:
Hvis du holder op med at tage Seroquel Prolong Hvis du pludselig stopper med at tage Seroquel Prolong, kan det være, at du får svært ved at sove, får kvalme eller hovedpine, diarré, opkastning, bliver svimmel eller irritabel.
If you suddenly stop taking Seroquel XR, you may be unable to sleep (insomnia), you may feel sick (nausea), or you may experience headache, diarrhoea, being sick (vomiting), dizziness or irritability.
Seroquel Prolong tabletter indeholder 50 mg, 150 mg, 200 mg, 300 mg eller 400 mg quetiapin (som quetiapinfumarat).
Seroquel XR tablets contain 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
Placebokontrollerede korttidsforsøg (over 3 til 8 uger) med en fast dosis (50 mg/dag til 800 mg/dag) viste en gennemsnitlig vægtøgning hos quetiapinbehandlede patienter på 0,8 kg ved en daglig dosis på 50 mg til 1,4 kg ved 600 mg/dag (hvor den laveste vægtøgning forekom ved 800 mg/dag) sammenlignet med 0,2 kg hos placebobehandlede patienter.
In short term, fixed dose (50mg/d to 800 mg/d), placebo-controlled studies (ranging from 3 to 8 weeks), the mean weight gain for quetiapine-treated patients ranged from 0.8 kg for the 50 mg daily dose to 1.4 kg for the 600 mg daily dose (with lower gain for the 800 mg daily dose), compared to 0.2 kg for the placebo treated patients.
(10) I akutte placebokontrollerede monoterapiforsøg, hvor seponeringssymptomer blev evalueret, blev følgende seponeringssymptomer hyppigst observeret: Søvnløshed, kvalme, opkastning, hovedpine, diarré, svimmelhed og irritabilitet.
Occurs predominantly during the early weeks of treatment (10) The following withdrawal symptoms have been observed most frequently in acute placebo-controlled, monotherapy clinical trials, which evaluated discontinuation symptoms: insomnia, nausea, headache, diarrhoea, vomiting, dizziness, and irritability.
Et forenklet doseringsregime kan opnås ved, at patienter som bliver behandlet med Seroqueltabletter 2 gange dagligt skiftes til Seroquel Prolong ved ekvivalente totaldoser indtaget én gang dagligt.
For more convenient dosing, patients who are currently being treated with divided doses of immediate release Seroquel tablets may be switched to Seroquel XR at the equivalent total daily dose taken once daily.
I alle kliniske forsøg (placebokontrollerede, open-label, aktiv komparator; 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 0,21 % og 0 % hos de patienter, som fik placebo.
In all clinical trials (placebocontrolled, open-label, active comparator; patients with a baseline neutrophil count ≥1.5 X 109/L), the incidence of at least one occurrence of neutrophil count <0.5 X 109/L was 0.21% in patients treated with quetiapine and 0% in placebo treated patients and the incidence ≥0.5 - <1.0 X 109/L was 0.75% in patients treated with quetiapine and 0.11% in placebo-treated patients.
Besvimelse4,17, ekstrapyramidale symptomer1,21 Dysarti
Extrapyramidal symptoms1, 21, Dysarthria
Opdatering af protokollerne for følgende igangværende sikkerhedsundersøgelser efter godkendelsen (PASS) med henblik på at indsamle data for sikkerheden af quetiapin XR på lang sigt hos MDD-patienter:
National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders: Update the protocols for the following ongoing Post Authorisation Safety Studies (PASSs) to collect long-term safety data of quetiapine XR in MDD patients: ¾ Modified Prescription Event Monitoring (M-PEM) Study;
Til behandling af depressive episoder inden for bipolar lidelse Seroquel Prolong bør tages ved sengetid.
For the treatment of depressive episodes in bipolar disorder Seroquel XR should be administered at bedtime.
Blod og lymfesystem Almindelig:
Blood and lymphatic system disorders
Ved et korttidsforsøg (9 uger) med ældre patienter uden demens (i alderen 66 til 89 år) med svær depression blev der påvist en bedre virkning med Seroquel Prolong overfor placebo hvad angik reduktion af de depressive symptomer målt ved forbedring af MADRS-totalscoren (gennemsnitlig ændring vs. placebo på -7,54).
In a short-term (9 week) study non-demented elderly patients (aged 66 to 89 years) with major depressive disorder, Seroquel XR dosed flexibly in the range of 50 mg to 300 mg/day demonstrated superior efficacy to placebo in reducing depressive symptoms as measured by improvement in MADRS total score (LS mean change vs placebo -7.54).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvar tablet indeholder 50 mg quetiapin (som fumarat)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg quetiapine (as fumarate)
Krampeanfald:
Cardiovascular:
• Feber, ondt i halsen over længere tid eller mundsår, hurtigt åndedræt, svedeture, muskelstivhed, følelse af stærk døsighed eller besvimelse.
• A high temperature (fever), long lasting sore throat or mouth ulcers, faster breathing, sweating,
Placebokontrollerede korttidsforsøg med bipolar depression viste en samlet hyppighed af ekstrapyramidale symptomer på 8,9 % for quetiapin sammenlignet med 3,8 % for placebo.
In short-term, placebo-controlled bipolar depression trials the aggregated incidence of extrapyramidal symptoms was 8.9% for quetiapine compared to 3.8% for placebo.
(11) Mindst ét tilfælde af triglycerider ≥200 mg/dl (≥2,258 mmol/l) (patienter ≥18 år) eller ≥150 mg/dl (≥1,694 mmol/l) (patienter <18 år).
(11) Triglycerides ≥200 mg/dL (≥2.258 mmol/L) (patients ≥18 years of age) or ≥150 mg/dL (≥1.694 mmol/L) (patients <18 years of age) on at least one occasion (12) Cholesterol ≥240 mg/dL (≥6.2064 mmol/L) (patients ≥18 years of age) or ≥200 mg/dL (≥5.172 mmol/L) (patients <18 years of age) on at least one occasion.
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Forhøjet blod-kreatin fosfokinase
Elevations in blood creatine phosphokinase15
- Bliver svimmel eller pludseligt føler dig meget søvnig.
Dizziness or a severe sense of feeling sleepy.
Mænd og kvinder kan få øget brystudvikling og uventet produktion af brystmælk (galaktoré).
• Men and women to have swelling of breasts and unexpectedly produce breast milk.
Dette kan øge risikoen for ulykker (fald)
This could increase the risk of accidental injury (fall) in elderly patients.
Seroquel Prolong indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for heriditær lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
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Ekstrapyramidale symptomer:
Extrapyramidal symptoms:
For nogle atypiske antipsykotika er der i randomiserede placebo-kontrollerede forsøg set en ca. 3dobbelt øget risiko for cerebrovaskulære bivirkninger i demens- populationen.
An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled trials in the dementia population with some atypical antipsychotics.
Ved anvendelse af neuroleptika er der rapporteret QT forlængelse, ventrikulær-arytmi, pludselig uforklarlig død, hjertestop og torsades de pointes.
Cases of QT prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and torsades de pointes have been reported with the use of neuroleptics and are considered class effects.
• behandling af skizofreni inklusive: o Forebyggelse af tilbagefald hos stabile skizofrenipatienter, der har vist initialt behandlingsrespons på Seroquel Prolong.
• treatment of schizophrenia including preventing relapses in stable schizophrenic patients who have been maintained on Seroquel XR.
• Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
Sjælden (sker hos færre end 1 ud af 1.000 personer):
Rare (affects less than 1 in 1,000 people):
Der er begrænset data for quetiapin i kombination med divalproex eller lithium til behandling af akutte moderate til svære maniske episoder, dog var kombinations-behandling veltolereret (se pkt.
Quetiapine data in combination with divalproex or lithium in acute moderate to severe manic episodes is limited; however, combination therapy was well tolerated (see section 4.8 and 5.1).
Vægtøgning, besvimelse, malignt neuroleptikasyndrom, leukopeni, neutropeni og perifært ødem har som for andre antipsykotika været forbundet med quetiapin.
As with other antipsychotics, weight gain, syncope, neuroleptic malignant syndrome, leucopenia, neutropenia and peripheral oedema, have been associated with quetiapine.
Meget almindelig (sker hos flere end 1 ud af 10 personer):
Very common (affects more than 1 in 10 people):
De samme bivirkninger, som er beskrevet ovenfor for voksne, bør forventes hos børn og unge.
Children and adolescents (10 to 17 years of age) The same ADRs described above for adults should be considered for children and adolescents.
Seroquel Prolong bør anvendes med forsigtighed hos patienter med risiko for at få et slagtilfælde.
Seroquel XR should be used with caution in patients with risk factors for stroke.
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4.8) indtrådte visse bivirkninger med større hyppighed hos børn og unge sammenlignet med voksne (øget appetit, forhøjet serumprolaktin og ekstrapyramidale symptomer), og der blev identificeret én bivirkning, som ikke tidligere er set i forsøg med voksne (forhøjet blodtryk).
Clinical trials with Seroquel have shown that in addition to the known safety profile identified in adults (see section 4.8), certain adverse events occurred at a higher frequency in children and adolescents compared to adults (increased appetite, elevations in serum prolactin and extrapyramidal symptoms) and one was identified that has not been previously seen in adult studies (increases in blood pressure).
Selvmord/selvmordstanker eller klinisk forværring I korttids placebo-kontrollerede kliniske forsøg med Seroquel med pædiatriske patienter med skizofreni var forekomsten af selvmordsrelaterede hændelser 1,4 % (2/147) for quetiapin og 1,3 % (1/75) for placebo hos patienter på <18 år.
In short-term placebo-controlled clinical trials with Seroquel in paediatric patients with schizophrenia, the incidence of suicide related events was 1.4% (2/147) for quetiapine and 1.3% (1/75) for placebo in patients <18 years of age.
I et placebokontrolleret korttids-monoterapiforsøg med ældre patienter med unipolar depression var den samlede forekomst af ekstrapyramidale symptomer 9,0 % for Seroquel Prolong og 2,3 % for placebo.
In a short-term placebo-controlled monotherapy trial in elderly patients with major depressive disorder, the aggregated incidence of extrapyramidal symptoms was 9.0% for Seroquel XR and 2.3% for placebo.
Må ikke deles, knuses eller tygges.
Do not split, chew or crush the tablets.
Ekstrapyramidale symptomer
Extrapyramidal Symptoms
Thyroxin-binding globulin (TBG) niveauet var uændret, og generelt sås ingen reciprok stigning i thyrotropin (thyroid stimulating hormone, TSH).
Levels of TBG were unchanged and in general, reciprocal increases in TSH were not observed, with no indication that quetiapine causes clinically relevant hypothyroidism.
Tre ud af fire korttidsforsøg (op til 8 uger) forsøg, hvor Seroquel Prolong blev givet som monoterapi til patienter med alvorlige depressive lidelser, viste at Seroquel Prolong 50 mg, 150 mg og 300 mg daglig var bedre end placebo til at reducere depressive symptomer, målt ved forbedring af MADRStotalscoren (gennemsnitlig ændring vs. placebo på 2-4 point).
In three out of four short term (up to 8 weeks) monotherapy studies, in patients with major depressive disorder, Seroquel XR 50 mg, 150 mg and 300 mg/day demonstrated superior efficacy to placebo in reducing depressive symptoms as measured by improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score (LS mean change vs. placebo of 2-4 points).
Seroquel Prolong indeholder det aktive stof quetiapin.
Seroquel XR contains a substance called quetiapine.
Spørg lægen eller på apoteket, hvis der er noget, du er i tvivl om, eller føler dig usikker på.
You should check with your doctor or pharmacist if you are not sure.
Tag ikke Seroquel Prolong hvis: du er overfølsom (allergisk) over for quetiapin eller et af de øvrige indholdsstoffer (se pkt.
Do not take Seroquel XR if: you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Seroquel XR (see section 6: Further information) you are taking any of the following medicines: - some medicines for HIV - azole medicines (for fungal infections) - erythromycin or clarithromycin (for infections) - nefazodone (for depression).