natgillin/translations-raw huggingface dataset:
Som en konsekvens af denne interaktion, kan lavere plasmakoncentrationer forekomme, hvilket kan påvirke effekten af Seroquel Prolong. 
As a consequence of this interaction, lower plasma concentrations can occur, which could affect the efficacy of Seroquel XR therapy.
Hyperglykæmi: 
Hyperglycaemia:
AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer Holland 
AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands
- du har sukkersyge, eller har risiko for at få det. 
You have diabetes or have a risk of getting diabetes.
Selvmord/selvmordstanker eller klinisk forværring: 
Suicide/suicidal thoughts or clinical worsening:
Disse data viser ikke en kausal sammenhæng mellem quetiapin behandling og død hos ældre demenspatienter. 
These data do not establish a causal relationship between quetiapine treatment and death in elderly patients with dementia.
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. 
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.
To korttidsforsøg (6 uger) indrullerede patienter, som havde vist utilstrækkeligt respons på mindst et antidepressivum. 
Two short-term (6 week) studies enrolled patients who had shown an inadequate response to at least one antidepressant.
CHMP bemærkede dog, at mønsteret for utilsigtede hændelser i den randomiserede fase af denne undersøgelse lignede mønsteret i undersøgelserne af den kortsigtede virkning. 
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.
Behandling med quetiapin er blevet sat i forbindelse med små dosisrelaterede fald i thyreoideahormonniveauer, især total T4 og fri T4. 
Quetiapine treatment was associated with small dose-related decreases in thyroid hormone levels, particularly total T4 and free T4.
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE 
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
• 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. 
• 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
Steady-state peak molære koncentrationer af den aktive metabolit norquetiapin er 35 % af den, der er set for quetiapin. 
Steadystate peak molar concentrations of the active metabolite norquetiapine are 35% of that observed for quetiapine.
Hyperprolaktinæmi16 
Hyperprolactinemia16
Eosinofili, thrombocytopeni 
Eosinophilia, Thrombocytopenia
Mulige neutropeni risikofaktorer er et eksisterende lavt antal hvide blodlegemer (WBC) og tidligere medicininduceret neutropeni. 
Possible risk factors for neutropenia include pre-existing low white cell count (WBC) and history of drug induced neutropenia.
Patienterne skal observeres med hensyn til tegn og symptomer på infektion og neutrofiltallet skal følges (indtil det overstiger <1,5 x 109/l). 
Patients should be observed for signs and symptoms of infection and neutrophil counts followed (until they exceed 1.5 X 109/L).
Det blev påvist, at sikkerhedsprofilen hos MDD-populationen var i overensstemmelse med quetiapins velkendte sikkerhedsprofil i andre indikationer. 
The safety profile in the MDD population was shown consistent with the already known safety profile of quetiapine in other indications.
Priapismus, galaktoré 
Priapism, Galactorrhoea
Venøs tromboemboli (VTE): 
Venous Thromboembolism (VTE):
Efter graviditeter, hvorunder quetiapin var anvendt, blev der observeret seponeringssymptomer hos nyfødte. 
Following pregnancies in which quetiapine was used, neonatal withdrawal symptoms were observed.
Forstoppelse, dyspepsi 
Constipation, dyspepsia
Det blokerer også virkningen af dopaminagonister, enten målt adfærdsmæssigt eller elektrofysiologisk og forhøjer dopamins metabolitkoncentrationer, et neurokemisk udtryk for D2 receptor blokering. 
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.
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) 
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).
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. 
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.
(3) Asymptomatiske stigninger i serumtransaminaser (ALT, AST) eller gamma-GT niveauer er observeret hos nogle patienter i quetiapinbehandling. 
(3) Asymptomatic elevations in serum transaminase (ALT, AST) or gamma-GT-levels have been observed in some patients administered quetiapine.
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. 
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.
Farmakokinetikken af quetiapin og norquetiapin er lineær og proportional med dosis for doser op til 800 mg administreret én gang dagligt. 
The pharmacokinetics of quetiapine and norquetiapine are linear and dose-proportional for doses up to 800 mg administered once daily.
Nedsat nyrefunktion: Justering af dosis er ikke nødvendigt hos patienter med nedsat nyrefunktion. 
Renal impairment: Dosage adjustment is not necessary in patients with renal impairment.
Særlige grupper 
Special populations
Gennemsnitsændringen blandt patienter med denne stigning var 41,7 mg/dl (≥1,07 mmol/l). 
Mean change among patients who had this increase was 41.7 mg/dL ( 1.07 mmol/L).
Kvinder kan få manglende eller uregelmæssig menstruation. 
• Women to have no monthly period or irregular periods.
Neutropeni1 
Neutropenia 1
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. 
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.
• Ufrivillige muskelbevægelser. 
• Abnormal muscle movements.
I et specifikt interaktionsforøg hos psykotiske patienter sås dog ingen stigning i cytochrom P450 aktiviteten efter administration af quetiapin. 
In a specific interaction study in psychotic patients, however, no increase in the cytochrome P450 activity was found after administration of quetiapine.
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. 
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.
• Leverbetændelse (hepatitis). 
• Inflammation of the liver (hepatitis)
Den gennemsnitlige clearence af quetiapin hos ældre er ca. 30 til 50 % lavere end hos voksne mellem 18 og 65 år. 
The mean clearance of quetiapine in the elderly is approximately 30 to 50% lower than that seen in adults aged 18 to 65 years.
Primær effektparameter i det placebo-kontrollerede forsøg var ændring i PANSS total fra baseline til endelig evaluering. 
The primary outcome variable in the placebo-controlled trial was change from baseline to final assessment in the PANSS total score.
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. 
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.
En 26-ugers open-label forlængelse af de akutte forsøg (n=380 patients) med Seroquel med en fleksibel dosis på 400-800 mg/dag gav yderligere sikkerhedsdata. 
A 26-week open-label extension to the acute trials (n= 380 patients), with Seroquel flexibly dosed at 400-800 mg/day, provided additional safety data.
nefazodon (mod depression). 
Nefazodone (for depression).
Andre psykiske lidelser, for hvilke der ordineres Seroquel Prolong, er også forbundet med en øget risiko for selvmordsrelaterede hændelser. 
Other psychiatric conditions for which Seroquel XR is prescribed can also be associated with an increased risk of suicide related events.
Udførelse af følgende nye PASS-undersøgelser hos MDD-patienter for yderligere at fastlægge sikkerheden og brugen af quetiapin XR på lang sigt, herunder rammerne for specialistbehandling. 
Perform the following new PASS studies in MDD patients to further characterise the long-term safety and use of quetiapine XR, including the specialist care setting:
- Får ufrivillige bevægelser, specielt i ansigtet eller tungen. 
Uncontrollable movements, mainly of your face or tongue.
ES- Spanien 
ES- Spain
• Søvnighed (forsvinder oftest med tiden, når du fortsætter med at tage Seroquel Prolong) (kan medføre fald). 
• Feeling sleepy (this may go away with time, as you keep taking Seroquel XR) (may lead to falls).
Endvidere blev der udført et 6-ugers placebo-kontrolleret forsøg vedrørende behandling af skizofreni (n=222 patienter i alderen 13-17). 
In addition, a 6-week placebo controlled study for the treatment of schizophrenia (n = 222 patients, aged 13-17) was performed.
CHMP revurderede de data, som indehaveren af markedsføringstilladelsen havde fremsendt under den gensidige anerkendelsesprocedure for type II-ændringen, samt yderligere oplysninger, som indehaveren af markedsføringstilladelsen havde fremsendt skriftligt og under mundtlige redegørelser i forbindelse med denne indbringelsesprocedure. 
The CHMP re-evaluated the data submitted by the MAH in the Mutual Recognition type II variation, additional information submitted by the MAH in written and by oral explanations during this referral procedure.
Din læge vil muligvis fortsat ordinere Seroquel Prolong, selvom du får det bedre. 
Your doctor may continue to prescribe Seroquel XR even when you are feeling better.
- du er en ældre, dement person (nedsat hjernefunktion). 
You are an elderly person with dementia (loss of brain function).
Fortæl det altid til lægen eller på apoteket, hvis du tager anden medicin eller har taget det for nylig, da det kan påvirke den måde, medicinen virker på. 
Please tell your doctor if you are taking or have recently taken any other medicines because it may affect the way the medicines work.
Selv om der mangler data for langtidsvirkningen, konkluderede udvalget, at det var acceptabelt at ekstrapolere vedligeholdelsesdata fra monoterapiundersøgelserne, 
Although long-term efficacy data are lacking the committee concluded to be acceptable to extrapolate maintenance data from the monotherapy studies.
I næsten alle tilfælde medførte ophør af Seroquelbehandling reversibilitet i effekten på henholdsvis total og fri T4, uafhængigt af behandlingens varighed. 
In nearly all cases, cessation of Seroquel treatment was associated with a reversal of the effects on total and free T4, irrespective of the duration of treatment.
Tag ikke Seroquel Prolong, hvis ovenstående gælder for dig. 
Do not take Seroquel XR if the above applies to you.
Hyppigheden faldt signifikant 1 uge efter seponering. 
The incidence of these reactions had decreased significantly after 1 week postdiscontinuation.
Quetiapin har ikke nogen væsentlig affinitet til muscarine receptorer eller benzodiazepin receptorer. 
Quetiapine has no appreciable affinity at muscarinic or benzodiazepine receptors.
Det er vigtigt, at enhver ændring af behandlingen med induceren sker gradvist og hvis nødvendigt, at erstatte denne med en non-inducer (f.eks natriumvalproat). 
It is important that any change in the inducer is gradual, and if required, replaced with a non-inducer (e.g. sodium valproate).
• Mani: Du kan føle dig meget opstemt, opløftet, ophidset, begejstret eller hyperaktiv eller have en dårlig dømmekraft, eller du kan have enaggressiv eller destruktiv opførsel. 
• Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
- CHMP anerkendte, at der for tillægsbehandling er påvist relevante virkninger hos patienter, som ikke responderer på mindst én antidepressiv behandling. 
- The CHMP recognised that for add-on treatment relevant effects have been demonstrated in patients not responding to at least one antidepressant treatment.
Seroquel Prolong kan, som al anden medicin, give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, Seroquel XR can cause side effects, although not everybody gets them.
Vigtig information om nogle af de øvrige indholdsstoffer i Seroquel Prolong Seroquel Prolong indeholder lactose, som er en sukkerart. 
Important information about some of the ingredients of Seroquel XR Seroquel XR contains lactose which is a type of sugar.
Quetiapin metaboliseres i vid udstrækning i leveren. 
Quetiapine is extensively metabolized by the liver.
Der bør udvises forsigtighed, når quetiapin anvendes samtidig med lægemidler, som er kendt for at medføre elektrolytubalance eller øge QT intervallet. 
Caution should be exercised when quetiapine is used concomitantly with medicinal products known to cause electrolyte imbalance or to increase QT interval.
(19) Hyppigheden af patienter med et QTc skift fra <450 msek. 
(19) Incidence of patients who have a QTc shift from <450 msec to ≥450 msec with a ≥30 msec increase.
Ved steady-state lignede de dosisnormaliserede plasmaniveauer af moderstoffet, quetiapin, hos børn og unge (10-17 år) generelt voksnes, selvom Cmax hos børn var i den højere ende af det område, som blev observeret hos voksne. 
At steady-state, the dosenormalized plasma levels of the parent compound, quetiapine, in children and adolescents (10-17 years of age) were in general similar to adults, though Cmax in children was at the higher end of the range observed in adults.
Seroquels effekt og sikkerhed blev undersøgt i et 3-ugers placebo-kontrolleret forsøg vedrørende behandling af mani (n=284 patienter fra USA i alderen 10-17). 
The efficacy and safety of Seroquel was studied in a 3-week placebo controlled study for the treatment of mania (n= 284 patients from the US, aged 10-17).
anbefalede CHMP godkendelse af ansøgningen om ændring af de(n) markedsføringstilladelse(r), for hvilke produktresumé og indlægsseddel fremgår af bilag III, for Seroquel XR og tilknyttede navne (se bilag I) i henhold til betingelserne i bilag IV. 
The CHMP has recommended the granting of the variation of the Marketing Authorisation(s) for which the Summary of Product Characteristics and package leaflet are set out in Annex III for Seroquel XR and associated names (see Annex I) and in accordance to the conditions set out in Annex IV.
• Svaghedsfølelse, besvimelse (kan medføre fald). 
• Feeling weak, fainting (may lead to falls).
Information fra kliniske forsøg viser, at der er en øget risiko for selvmordstanker og/eller selvmordsadfærd hos yngre voksne under 25 år med depression. 
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.
Protokollen skal fremsendes til referencemedlemsstaten senest to måneder efter CHMP's udtalelse om denne indbringelsesprocedure. 
The protocol should be submitted to the Reference Member State within two months of the CHMP Opinion on this referral procedure.
Hvis du er gravid, forsøger at blive gravid eller ammer, bør du tale med din læge, før du tager Seroquel Prolong. 
If you are pregnant, trying to get pregnant, or breast-feeding, talk to your doctor before taking Seroquel XR.
Ikke kendt: 
Unknown:
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne. 
Hypersensitivity to the active substance or to any of the excipients of this product.
Forhøjet serumprolaktin1, forhøjet blodtryk2 
Elevations in prolactin1, increases in blood pressure2
Der er øget risiko for bivirkningerved højere doser. 
There is an increased risk of adverse events at higher doses.
På baggrund heraf er samtidig brug af quetiapin og CYP 3A4 inhibitorer kontraindiceret. 
On the basis of this, concomitant use of quetiapine with CYP3A4 inhibitors is contraindicated.
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 glukosekontrol. 
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.
Derfor bør patienter advares mod at køre bil eller betjene maskiner, indtil den enkeltes påvirkelighed er kendt. 
Therefore, patients should be advised not to drive or operate machinery, until individual susceptibility to this is known.
Farmakokinetiske data blev undersøgt hos 9 børn i alderen 10-12 år og 12 unge, som var på steadystate behandling med 400 mg quetiapin (Seroquel) to gange daglig. 
Children and adolescents (10 to 17 years of age) 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 (Seroquel) twice daily.
Anafylaktiske reaktioner6 
Anaphylactic reaction6
Baseret på ændringer over klinisk signifikante tærskler (tilpasset fra National Institutes of Healths kriterier) eller stigninger på >20 mmHg for systolisk eller >10 mmHg for diastolisk blodtryk ved ethvert tidspunkt i to akutte (3-6 uger) placebo-kontrollerede forsøg med børn og unge. 
Based on shifts above clinically significant thresholds (adapted from the National Institutes of Health criteria) or increases >20mmHg for systolic or >10 mmHg for diastolic blood pressure at any time in two acute (3-6 weeks) placebo-controlled trials in children and adolescents.
AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU Storbritannien 
IE - Ireland AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU
Leukopeni1 
Leucopenia 1
I prækliniske tests, hvor der undersøges for EPS tilbøjeligheden, adskiller quetiapin sig fra de typiske antipsykotika og har en atypisk profil. 
In pre-clinical tests predictive of EPS, quetiapine is unlike typical antipsychotics and has an atypical profile.
• Bipolar depression og depressive episoder ved unipolar depression: Du føler dig ked af det, eller du kan føle dig deprimeret, have skyldfølelse, mangle energi, miste appetitten eller have svært ved at sove. 
• Bipolar depression and major depressive episodes in major depressive disorder: where you may feel sad or you may find that you feel depressed, feel guilty, lack energy, lose your appetite or can't sleep.
Indtil nu er der ingen antydninger af skadelige virkninger i dyreforsøg. 
Up to now there are no indications for harmfulness in animal tests, possible effects on the foetal eye have not been examined, though.
Quetiapins farmakokinetik blev ikke ændret signifikant som følge af samtidig administration af de antidepressive midler imipramin (en kendt CYP2D6 inhibitior) eller fluoxetin (en kendt CYP3A4 og CYP2D6 inhibitor). 
The pharmacokinetics of quetiapine were not significantly altered by co-administration of the antidepressants imipramine (a known CYP 2D6 inhibitor) or fluoxetine (a known CYP 3A4 and CYP 2D6 inhibitor).
Bivirkningshyppigheden er inddelt som: Meget almindelig (≥1/10), almindelig (≥1/100, <1/10), ikke almindelig (≥1/1000, <1/100), sjælden (≥1/10000, <1/1000) og meget sjælden (<1/10000). 
The frequencies of adverse events are ranked according to the following: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100, rare (≥1/10,000, <1/1000) and very rare (<1/10,000).
NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussel Belgien 
NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussel Belgium
De ændrede protokoller skal fremsendes til referencemedlemsstaten senest to måneder efter CHMP's udtalelse om denne indbringelsesprocedure. 
The amended protocols should be submitted to the Reference Member State within two months of the CHMP Opinion on this referral procedure.
Quetiapin og norquetiapin har også høj affinitet for histaminerge- og adrenerge α1 receptorer og en lavere affinitet for adrenerge α2 og serotonin 5HT1A receptorer. 
Quetiapine and norquetiapine also have high affinity at histaminergic and adrenergic α1 receptors, with a lower affinity at adrenergic α2- and serotonin 5HT1A receptors.
Den estimerede risiko for tilbagefald efter 6 måneders behandling var 14,3 % for Seroquel Prolong behandlingsgruppen sammenlignet med 68,2 % for placebo. 
The estimated risks of relapse after 6 months treatments was 14.3% for the Seroquel XR treatment group compared to 68.2% for placebo.
Ældre patienter med demens-relateret psykose: Seroquel Prolong er ikke godkendt til behandling af patienter med demens relateret psykose. 
Elderly patients with dementia-related psychosis: Seroquel XR is not approved for the treatment of dementia-related psychosis.
• Forebyggelse af tilbagevendende sygdomsepisoder hos patienter med bipolær lidelse, hvis maniske eller depressive episode har responderet på quetiapinbehandling. 
• prevention of recurrence in patients with bipolar disorders, in patients whose maniac or depressive episode has responded to quetiapine treatment.
Den overordnede sikkerhedsprofil hos ældre patienter lignede sikkerhedsprofilen hos yngre voksne patienter, men der blev observeret en større hyppighed af somnolens, svimmelhed og ekstrapyramidale symptomer (EPS). 
The overall safety profile in the elderly patients was similar to that in younger adult patients; however a higher frequency of somnolence, dizziness and extrapyramidal symptoms (EPS) was observed.
I opfølgningsfasen i to af disse kliniske forsøg blev det vist, at langtidsbehandling af patienter, som responderede på Seroquel 300 eller 600 mg var effektfuldt sammenlignet med placebobehandling med hensyn til depresssive symptomer, men ikke hvad angår maniske symptomer. 
In the continuation phase in two of these studies, it was demonstrated that long-term treatment, of patients who responded on Seroquel IR 300 or 600 mg, was efficacious compared to placebo treatment with respect to depressive symptoms, but not with regard to manic symptoms.