FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Nefazodone (for depression).
Danish: nefazodon (mod depression).
English: Other psychiatric conditions for which Seroquel XR is prescribed can also be associated with an increased risk of suicide related events.
Danish: Andre psykiske lidelser, for hvilke der ordineres Seroquel Prolong, er også forbundet med en øget risiko for selvmordsrelaterede hændelser.
English: 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:
Danish: 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.
English: Uncontrollable movements, mainly of your face or tongue.
Danish: - Får ufrivillige bevægelser, specielt i ansigtet eller tungen.
English: ES- Spain
Danish: ES- Spanien
English: • Feeling sleepy (this may go away with time, as you keep taking Seroquel XR) (may lead to falls).
Danish: • Søvnighed (forsvinder oftest med tiden, når du fortsætter med at tage Seroquel Prolong) (kan medføre fald).
English: In addition, a 6-week placebo controlled study for the treatment of schizophrenia (n = 222 patients, aged 13-17) was performed.
Danish: Endvidere blev der udført et 6-ugers placebo-kontrolleret forsøg vedrørende behandling af skizofreni (n=222 patienter i alderen 13-17).
English: 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.
Danish: 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.
English: Your doctor may continue to prescribe Seroquel XR even when you are feeling better.
Danish: Din læge vil muligvis fortsat ordinere Seroquel Prolong, selvom du får det bedre.
English: You are an elderly person with dementia (loss of brain function).
Danish: - du er en ældre, dement person (nedsat hjernefunktion).
English: Please tell your doctor if you are taking or have recently taken any other medicines because it may affect the way the medicines work.
Danish: 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.
English: Although long-term efficacy data are lacking the committee concluded to be acceptable to extrapolate maintenance data from the monotherapy studies.
Danish: Selv om der mangler data for langtidsvirkningen, konkluderede udvalget, at det var acceptabelt at ekstrapolere vedligeholdelsesdata fra monoterapiundersøgelserne,
English: 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.
Danish: I næsten alle tilfælde medførte ophør af Seroquelbehandling reversibilitet i effekten på henholdsvis total og fri T4, uafhængigt af behandlingens varighed.
English: Do not take Seroquel XR if the above applies to you.
Danish: Tag ikke Seroquel Prolong, hvis ovenstående gælder for dig.
English: The incidence of these reactions had decreased significantly after 1 week postdiscontinuation.
Danish: Hyppigheden faldt signifikant 1 uge efter seponering.
English: Quetiapine has no appreciable affinity at muscarinic or benzodiazepine receptors.
Danish: Quetiapin har ikke nogen væsentlig affinitet til muscarine receptorer eller benzodiazepin receptorer.
English: It is important that any change in the inducer is gradual, and if required, replaced with a non-inducer (e.g. sodium valproate).
Danish: 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).
English: • Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
Danish: • 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.
English: - The CHMP recognised that for add-on treatment relevant effects have been demonstrated in patients not responding to at least one antidepressant treatment.
Danish: - CHMP anerkendte, at der for tillægsbehandling er påvist relevante virkninger hos patienter, som ikke responderer på mindst én antidepressiv behandling.
English: Like all medicines, Seroquel XR can cause side effects, although not everybody gets them.
Danish: Seroquel Prolong kan, som al anden medicin, give bivirkninger, men ikke alle får bivirkninger.
English: Important information about some of the ingredients of Seroquel XR Seroquel XR contains lactose which is a type of sugar.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Seroquel Prolong Seroquel Prolong indeholder lactose, som er en sukkerart.
English: Quetiapine is extensively metabolized by the liver.
Danish: Quetiapin metaboliseres i vid udstrækning i leveren.
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 elektrolytubalance eller øge QT intervallet.
English: (19) Incidence of patients who have a QTc shift from <450 msec to ≥450 msec with a ≥30 msec increase.
Danish: (19) Hyppigheden af patienter med et QTc skift fra <450 msek.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: • Feeling weak, fainting (may lead to falls).
Danish: • Svaghedsfølelse, besvimelse (kan medføre fald).
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 forsøg viser, at der er en øget risiko for selvmordstanker og/eller selvmordsadfærd hos yngre voksne under 25 år med depression.
English: The protocol should be submitted to the Reference Member State within two months of the CHMP Opinion on this referral procedure.
Danish: Protokollen skal fremsendes til referencemedlemsstaten senest to måneder efter CHMP's udtalelse om denne indbringelsesprocedure.
English: If you are pregnant, trying to get pregnant, or breast-feeding, talk to your doctor before taking Seroquel XR.
Danish: Hvis du er gravid, forsøger at blive gravid eller ammer, bør du tale med din læge, før du tager Seroquel Prolong.
English: Unknown:
Danish: Ikke kendt:
English: Hypersensitivity to the active substance or to any of the excipients of this product.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
English: Elevations in prolactin1, increases in blood pressure2
Danish: Forhøjet serumprolaktin1, forhøjet blodtryk2
English: There is an increased risk of adverse events at higher doses.
Danish: Der er øget risiko for bivirkningerved højere doser.
English: On the basis of this, concomitant use of quetiapine with CYP3A4 inhibitors is contraindicated.
Danish: På baggrund heraf er samtidig brug af quetiapin og CYP 3A4 inhibitorer kontraindiceret.
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 glukosekontrol.
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 eller betjene maskiner, indtil den enkeltes påvirkelighed er kendt.
English: 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.
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 (Seroquel) to gange daglig.
English: Anaphylactic reaction6
Danish: Anafylaktiske reaktioner6
English: 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.
Danish: 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.
English: IE - Ireland AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU
Danish: AstraZeneca UK Ltd 600 Capability Green Luton LU1 3LU Storbritannien
English: Leucopenia 1
Danish: Leukopeni1
English: In pre-clinical tests predictive of EPS, quetiapine is unlike typical antipsychotics and has an atypical profile.
Danish: I prækliniske tests, hvor der undersøges for EPS tilbøjeligheden, adskiller quetiapin sig fra de typiske antipsykotika og har en atypisk profil.
English: • 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.
Danish: • 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.
English: Up to now there are no indications for harmfulness in animal tests, possible effects on the foetal eye have not been examined, though.
Danish: Indtil nu er der ingen antydninger af skadelige virkninger i dyreforsøg.
English: 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).
Danish: 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).
English: 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).
Danish: 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).
English: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussel Belgium
Danish: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussel Belgien
English: The amended protocols should be submitted to the Reference Member State within two months of the CHMP Opinion on this referral procedure.
Danish: De ændrede protokoller skal fremsendes til referencemedlemsstaten senest to måneder efter CHMP's udtalelse om denne indbringelsesprocedure.
English: Quetiapine and norquetiapine also have high affinity at histaminergic and adrenergic α1 receptors, with a lower affinity at adrenergic α2- and serotonin 5HT1A receptors.
Danish: Quetiapin og norquetiapin har også høj affinitet for histaminerge- og adrenerge α1 receptorer og en lavere affinitet for adrenerge α2 og serotonin 5HT1A receptorer.
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: Elderly patients with dementia-related psychosis: Seroquel XR is not approved for the treatment of dementia-related psychosis.
Danish: Ældre patienter med demens-relateret psykose: Seroquel Prolong er ikke godkendt til behandling af patienter med demens relateret psykose.
English: • prevention of recurrence in patients with bipolar disorders, in patients whose maniac or depressive episode has responded to quetiapine treatment.
Danish: • Forebyggelse af tilbagevendende sygdomsepisoder hos patienter med bipolær lidelse, hvis maniske eller depressive episode har responderet på quetiapinbehandling.
English: 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.
Danish: 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).
English: 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.
Danish: 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.
English: Given the primary central nervous system effects of quetiapine, Seroquel XR should be used with caution in combination with other centrally acting medicinal products and alcohol.
Danish: Da quetiapin primært virker på centralnervesystemet, bør Seroquel Prolong anvendes med forsigtighed, når det kombineres med andre centraltvirkende lægemidler og alkohol.
English: The CHMP concluded that the safety profile for add-on treatment in short-term studies was similar to the safety demonstrated for mono-therapy.
Danish: CHMP konkluderede, at sikkerhedsprofilen for tillægsbehandling i korttidsundersøgelserne lignede den påviste sikkerhedsprofil for monoterapi.
English: Do not take Seroquel XR if you are taking any of the following medicines:
Danish: Du må ikke tage Seroquel Prolong, hvis du tager et af følgende lægemidler:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not split, chew or crush the tablets.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Må ikke deles, knuses eller tygges.
English: Longer term relapse prevention trials had an open label period (ranging from 4 to 36 weeks) during which patients were treated with quetiapine, followed by a randomized withdrawal period during which patients were randomized to quetiapine or placebo.
Danish: Recidivforebyggende langtidsforsøg havde en open label-periode (fra 4 til 36 uger), hvor patienterne blev behandlet med quetiapin, efterfulgt af en randomiseret afvænningsperiode, hvor patienterne blev randomiseret til quetiapin eller placebo.
English: Quetiapine produces only weak catalepsy at effective dopamine D2-receptor blocking doses.
Danish: Quetiapin forårsager kun svag katalepsi ved effektive dopamin D2 receptor blokerende doser.
English: Concomitant administration of cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole-antifungal agents, erythromycin, clarithromycin and nefazodone, is contraindicated.
Danish: Samtidig administrering af cytochrom P450 3A4 inhibitorer, såsom HIV-protease inhibitorer, svampemidler af azoltypen, erythromycin, clarithromycin og nefazodon er kontraindiceret (se pkt.
English: Quetiapine is an atypical antipsychotic agent, which together with its active metabolite - norquetiapine interacts with several neurotransmitter receptors.
Danish: Quetiapin er et atypisk antipsykotisk middel, som sammen med sin aktive metabolit, norquetiapin, indvirker på en lang række neurotransmitterreceptorer.
English: Taking these findings into consideration, the benefits of the treatment with quetiapine need to be balanced against the safety risks for the patient.
Danish: Med udgangspunkt i ovennævnte fund bør fordelene ved behandling med quetiapin afvejes mod risici for patienten.
English: Women who are breastfeeding should therefore be advised to avoid breast-feeding while taking Seroquel XR.
Danish: Kvinder, der ammer, anbefales derfor at undlade at amme, mens de tager Seroquel Prolong.
English: Given the observed changes in weight, blood glucose (see hyperglycemia) and lipids seen in clinical studies, there may be possible worsening of the metabolic risk profile in individual patients, which should be managed as clinically appropriate (see also section 4.8).
Danish: På baggrund af de observerede ændringer i vægt, blodglucose (se hyperglykæmi) og lidpider set i kliniske forsøg, kan der være en mulig forværring af den metaboliske risikoprofil hos enkelte patienter, som skal håndteres i henhold til normal klinisk praksis (se også pkt.
English: - The CHMP further concluded that, although long-term safety data are lacking, the potential long-term safety concerns (in particular metabolic changes, EPS related events) including the potentially possible combinations of quetiapine as add-on treatment to be appropriately manage by collection of data in the already ongoing and new post authorisation safety studies which will be included in the updated Risk Management Plan.
Danish: - CHMP konkluderede ligeledes, at selv om der mangler data for sikkerheden på lang sigt, kan de potentielle betænkeligheder med hensyn til sikkerheden på lang sigt (navnlig metaboliske ændringer og EPS-relaterede hændelser), herunder de potentielt mulige kombinationer af quetiapin som tillægsbehandling, tackles ved at indsamle data i de allerede igangværende og de nye sikkerhedsundersøgelser efter godkendelsen (PASS), som vil blive medtaget i den opdaterede risikostyringsplan,
English: It is this combination of receptor antagonism with a higher selectivity for 5HT2 relative to D2- receptors, which is believed to contribute to the clinical antipsychotic properties and low extrapyramidal undesirable effect (EPS) liability of Seroquel compared to typical antispychotics.
Danish: Det er denne kombination af receptorantagonisme med en højere selektivitet overfor 5HT2 i forhold til D2 receptorer, som menes at medvirke til de kliniske antipsykotiske egenskaber og tilbøjeligheden for få ekstrapyramidiale bivirkninger (EPS) for Seroquel sammenlignet med typiske antipsykotika.
English: In five placebo controlled monotherapy studies (including a study in elderly subjects) the effects of quetiapine in an unrestricted MDD population were shown.
Danish: I fem placebokontrollerede monoterapiundersøgelser (herunder en undersøgelse hos ældre patienter) påvistes virkningerne af quetiapin hos en ikke-afgrænset MDD-population.
English: Pharmacodynamic effects:
Danish: Farmakodynamisk effekt:
English: The two adjunct (add-on) therapy studies, in patients with inadequate response to at least one initial antidepressant showed statistically and clinically relevant effects for quetiapine compared to placebo.
Danish: De to tillægsbehandlingsundersøgelser hos patienter med en utilstrækkelig respons på mindst ét indledende antidepressivt middel viste statistisk og klinisk relevante virkninger af quetiapin sammenlignet med placebo.
English: • Uncontrollable movements, mainly of your face or tongue.
Danish: • Ufrivillige bevægelser, hovedsageligt ansigt og tunge.
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 én gang dagligt sammenlignes med den samme totale daglige dosis af quetiapinfumarat givet som Seroquel tabletter to gange dagligt, er arealet under plasma koncentration-tids kurven (AUC) ekvivalent, men den maksimale plasmakoncentration (Cmax) er 13 % lavere.
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: DE - Germany AstraZeneca GmbH, Tinsdaler Weg 183, 22880 Wedel,
Danish: AstraZeneca GmbH, Tinsdaler Weg 183, 22880 Wedel, Tyskland
English: Neither low dose (400 mg/day) nor high dose regimen (800 mg/day) quetiapine was superior to placebo with respect to the percentage of patients achieving response, defined as ≥30% reduction from baseline in PANSS total score.
Danish: I hverken lavdosis(400 mg/dag) eller højdosis-regimet (800 mg/dag) var quetiapin bedre end placebo med hensyn til procentdelen af patienter, der fik respons, defineret som ≥30 % reduktion fra baseline i PANSS totalscore.
English: An increase in LDL cholesterol of ≥30 mg/dL ( 0.769 mmol/L) has been very commonly observed.
Danish: Det er meget almindeligt, at der ses en stigning i LDL-kolesterol på ≥30 mg/dl (≥0,769 mmol/l).
English: You, or someone in your family, have or have had any heart problems, for example heart rhythm problems or if you are taking any medicines that may have an impact on the way your heart beats.
Danish: Tal med din læge, før du tager din medicin, hvis: du eller nogen i din familie har eller har haft hjerteproblemer, f.eks. problemer med hjerterytmen, eller hvis du tager medicin, der kan påvirke måden, hvorpå dit hjerte slår.
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 lithium behandlede grupper.