FrancophonIA/ELRC3.0 huggingface dataset:
English: Moreover, the CHMP requested further amendments to this section to include information on the need to conduct screening of metabolic parameters i.e. weight, glucose and lipids prior to treatment initiation and regularly during therapy.
Danish: Desuden anmodede CHMP om yderligere ændringer af dette afsnit med indsættelse af oplysninger om nødvendigheden af screening for metaboliske parametre, dvs. vægt, glukose og lipider, før initiering af behandlingen og løbende under behandlingen.
English: Quetiapine is an atypical antipsychotic agent, which together with its active metabolitenorquetiapine - interacts with a broad range of neurotransmitter receptors including serotonin 5hydroxytryptophan type 2 (5HT2A), dopamine type 1 and type 2 (D1, D2), histamine and adrenergic receptors (greatly α1).
Danish: Quetiapin er et atypisk antipsykotikum, der sammen med sin aktive metabolit - norquetiapininteragerer med en lang række neurotransmitter-receptorer, herunder serotonin 5-hydroxytryptophan type 2-receptorer (5HT2A), dopamin type 1- og type 2-receptorer (D1, D2), histaminreceptorer og adrenerge receptorer (særlig α1).
English: However, the CHMP recommended moving this warning to a more prominent place in this section in order to increase awareness to the risk of developing metabolic syndrome associated with quetiapine treatment.
Danish: CHMP anbefalede dog at flytte denne advarsel til en mere fremtrædende plads i dette afsnit for at henlede opmærksomheden på risikoen for metabolisk syndrom ved behandling med quetiapin.
English: Redundant text related to resolution of leucopenia and/or neutropenia following cessation of quetiapine treatment because recovery is implied later in the same paragraph i.e. “Patients should be observed for signs and symptoms of infection and neutrophil counts followed until they exceed 1.5 X 109/l” was removed.
Danish: Overflødig tekst om resolution af leukopeni og/eller neutropeni efter ophør af behandling med quetiapin blev slettet, da der senere i samme afsnit underforstået henvises til restitution, nemlig “patienterne bør observeres for tegn og symptomer på infektion og neutrofiltallet følges, indtil det er over 1,5 x 109/l”.
English: Somnolence and dizziness
Danish: Somnolens og svimmelhed
English: The warning concerning cardiovascular were agreed to be now under this heading i.e. “orthostatic hypotension” which has been re-named.
Danish: Det blev vedtaget, at advarslen om kardiovaskulære bivirkninger nu skulle placeres under denne overskrift, dvs. “ortostatisk hypotension”, som har skiftet betegnelse.
English: • The committee reviewed the data submitted by the MAH on the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the product information
Danish: • udvalget gennemgik de data, der er forelagt af indehaverne af markedsføringstilladelsen om eksisterende kliniske undersøgelser, lægemiddelovervågning og den publicerede litteratur som begrundelse for den foreslåede harmonisering af produktinformationen,
English: The indication “major depressive episodes” in the MRP SmPC was approved on November 2008 when the indication for bipolar depression was first approved.
Danish: Indikationen “svær manisk episode” i produktresuméet fra den gensidige anerkendelsesprocedure blev godkendt i november 2008 i forbindelse med den første godkendelse af indikationen bipolær depression.
English: There were also discrepancies regarding recommendations for special population groups namely elderly and paediatric, administration with/without food.
Danish: Der var også afvigelser i anbefalingerne for ældre og pædiatriske patienter og vedrørende administration sammen med eller mellem måltider.
English: Jaundice is a listed, rare adverse event with quetiapine (in section 4.8 of the SmPC).
Danish: Ikterus er anført som en sjælden bivirkning med quetiapin (i produktresuméets punkt 4.8).
English: The SmPC in other MSs does not include this information.
Danish: Produktresuméet i andre medlemsstater indeholder ikke denne oplysning.
English: The exact mechanism of action of quetiapine, similarly with other antipsychotics, is still unknown, but the combination of receptor antagonism with a higher selectivity for 5HT2 relative to D2 receptors may contribute to its psychotropic activity and mood stabilizing properties.
Danish: Quetiapins nøjagtige virkningsmekanisme er ligesom for andre antipsykotika stadig ukendt, men kombinationen af receptorantagonisme med større selektivitet for 5HT2- end for D2-receptorer kan være medvirkende til dets psykoaktive og stemningsstabiliserende egenskaber.
English: Discontinuing antipsychotic medication in stabilised patients is of particular concern, as well as the development of jaundice.
Danish: Seponering af antipsykotisk medicinering hos stabiliserede patienter er et særligt problem, hvilket ligeledes gælder opståen af ikterus.
English: Although there were no major divergences in the wording, a more concise text concerning cardiovascular to prevent redundancy was agreed aiming specific product information for the prescriber instead of common knowledge on symptoms and consequences of orthostatic hypotension.
Danish: Skønt der ikke var større divergenser i ordlyden, blev der vedtaget en mere kortfattet tekst om kardiovaskulære bivirkninger, hvor overflødige oplysninger var udeladt, og hvor der blev tilstræbt at give konkrete produktoplysninger til den ordinerende læge frem for generel viden om symptomer på og konsekvenser af ortostatisk hypotension.
English: Overall summary of the scientific evaluation of Seroquel/Seroquel XR and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Seroquel/Seroquel XR og relaterede navne (se bilag I)
English: The wording approved by the variation as follows: “Cardiomyopathy and myocarditis have been reported in clinical trials and during the post-marketing experience, however, a causal relationship to quetiapine has not been established.
Danish: Ved ændringen godkendtes følgende ordlyd: “Der er beskrevet kardiomyopati og myokarditis i kliniske undersøgelser og erfaringer efter markedsføring, men der er ikke fastslået årsagssammenhæng med quetiapin.
English: It is hereafter summarised the main points discussed for the harmonisation of the different sections of the SmPC.
Danish: Nedenstående er en sammenfatning af de hovedpunkter, der blev drøftet i forbindelse med harmoniseringen af de forskellige afsnit af produktresuméet.
English: The pivotal clinical studies for this indication were conducted in a patient population having moderate to severe manic episodes in bipolar disorder.
Danish: De kliniske hovedundersøgelser vedrørende denne indikation blev udført hos en patientpopulation med moderate til svære maniske episoder ved bipolær sygdom.
English: This section was also further amended to reflect the information already included in the package leaflet that exacerbation of pre-existing diabetes may occur.
Danish: Indholdet i dette afsnit blev desuden ændret med den oplysning, der i forvejen indgår i indlægssedlen: muligheden for forværring af præeksisterende diabetes.
English: Other warnings of this section i.e. Extrapyramidal symptoms, Tardive Dyskinesia, Seizures, Interactions, Weight, Hyperglycaemia, Elderly patients with dementia-related psychosis and Dysphagia were also harmonised for minor divergences identified among the SmPC approved in the several MSs.
Danish: Andre advarsler i dette afsnit, f.eks. ekstrapyramidale symptomer, tardiv dyskinesi, krampeanfald, interaktioner, vægt, hyperglykæmi og ældre patienter med demensrelateret psykose og dysfagi, blev ligeledes harmoniseret med hensyn til mindre afvigelser mellem de godkendte produktresuméer i en række medlemsstater.
English: The harmonised wording for the SmPC and found in the majority of the EU MSs i.e. “moderate to severe” is considered appropriate and provides useful information for the prescribing physician as to the patient population that will benefit from taking Seroquel.
Danish: Produktresuméets harmoniserede ordlyd, der anvendes i de fleste EU-medlemsstater, dvs. “moderat til svær”, anses for passende og informativ for den ordinerende læge om den patientpopulation, der vil have fordel af Seroquel.
English: The warning stated that “If jaundice develops, quetiapine should be discontinued”.
Danish: Advarslen lød: “Hvis der opstår ikterus, bør quetiapin seponeres”.
English: Therefore this warning was reworded to clearly state that patients need to immediately report the appearance of symptoms consistent with agranulocitosys or infection, during Seroquel therapy and physicians to proceed to white blood cells (WBC) count and absolute neutrophil count (ANC) in the absence of predisposition factors.
Danish: Denne advarsel blev derfor omformuleret, så den klart angiver, at patienterne øjeblikkelig skal melde om symptomer svarende til agranulocytose eller infektion under behandling med Seroquel, og at lægen skal sørge for bestemmelse af leukocyttal (WBC) og absolut neutrofiltal (ANC) i fravær af disponerende faktorer.
English: All MSs have the same or similar wording in their Seroquel and Seroquel XR SmPCs with regards absorption, distribution, elimination, gender, elderly and renal impairment.
Danish: Alle medlemsstater anvender samme eller ensartet ordlyd i produktresuméerne for Seroquel og Seroquel XR vedrørende absorption, fordeling, udskillelse, køn, ældre og nyrefunktionsnedsættelse.
English: In addition, the MAH reviewed data concerning this risk and confirmed no fatal cases of agranulocytosis in the clinical trial data set.
Danish: Indehaveren af markedsføringstilladelsen gennemgik desuden data vedrørende denne risiko og fastslog, at der ikke var fatale tilfælde af agranulocytose i datasættet fra de kliniske undersøgelser.
English: However, the CHMP considered the sentence regarding the need to consider balance on the benefits and risk of quetiapine to be redundant and was therefore agreed to be removed.
Danish: CHMP fandt dog, at sætningen om nødvendigheden af afvejning af fordele og risici ved quetiapin var overflødig og derfor burde fjernes.
English: • The committee agreed the harmonisation of the summary of product characteristics, labelling and package leaflets proposed by the marketing authorisation holder.
Danish: • udvalget godtog den harmonisering af produktresuméet, etiketteringen og indlægssedlerne, der er foreslået af indehaveren af markedsføringstilladelsen,
English: Studies in animals as explained in section 5.3 of the SmPC have shown reproductive toxicity.
Danish: Dyreforsøg har vist reproduktionstoksicitet som nævnt i punkt 5.3 af produktresuméet.
English: Seroquel XR or XL was first approved in the United States in May 2007 and it is available in 50 mg, 150 mg, 200 mg and 400 mg, and as prolonged released tablets in all European Union (EU) Member States (MS), with exception of Bulgaria and Poland.
Danish: Seroquel blev første gang godkendt i Det Forenede Kongerige i juli 1997 og leveres som tabletter med hurtig udløsning på 25 mg, 100 mg, 150 mg, 200 mg og 300 mg. Seroquel XR eller XL blev første gang godkendt i USA i maj 2007 og leveres som 50 mg, 150 mg, 200 mg og 400 mg tabletter og som depottabletter i alle EU's medlemsstater undtagen Bulgarien og Polen.
English: Seroquel and Seroquel XR are indicated for treatment of schizophrenia and bipolar disorder.
Danish: Seroquel og Seroquel XR er indiceret til behandling af skizofreni og bipolær sygdom.
English: Based on the above, the CHMP considers the benefit/risk ratio of Seroquel/Seroquel XR and associated names to be favourable and the harmonised Product Information documents to be approvable
Danish: På ovenstående grundlag finder CHMP benefit/risk-forholdet for Seroquel/Seroquel XR og relaterede navne positivt og kan godtage de harmoniserede produktinformationer.
English: The CHMP agreed that the wording was not acceptable to be included in the harmonised text, since prevention of relapse is considered to be part of good clinical practise in the treatment of schizophrenia and as such not required to be clearly specified in the therapeutic indication section of the SmPC.
Danish: CHMP fandt det ikke acceptabelt, at denne ordlyd skulle indgå i den harmoniserede tekst, da forebyggelse af recidiv anses for at høre med til god klinisk praksis ved skizofrenibehandling og som sådan ikke behøver specificeres i produktresuméets afsnit om terapeutiske indikationer.
English: Considering that the MAH had already committed to submit a cumulative review on hepatic effects within the PSUR in September 2014, the CHMP agreed that a harmonised wording in regard of hepatic effects should be assessed and agreed upon in the upcoming PSUR.
Danish: Da indehaveren af markedsføringstilladelsen allerede havde forpligtet sig til at indsende en samlet gennemgang af leverpåvirkning i den periodiske sikkerhedsopdateringsrapport (PSUR) i september 2014, bestemte CHMP, at der i forbindelse med den kommende PSUR skulle vurderes og vedtages en harmoniseret ordlyd om leverpåvirkning.
English: Mainly these regard missing information on children and adolescents who received valproate, quetiapine or both, and found a higher incidence of leucopenia and neutropenia in the combination group versus the monotherapy groups.
Danish: Afvigelserne vedrører hovedsagelig manglende oplysninger om børn og unge, som har fået valproat eller quetiapin eller begge dele, hvor der blev fundet højere forekomst af leukopeni og neutropeni med kombinationen end med monoterapi.
English: The CHMP addressed a list of questions to the MAH, pointing out the sections of the products SmPC where divergences existed.
Danish: CHMP stillede en række spørgsmål til indehaveren af markedsføringstilladelsen og udpegede de afsnit i produktresuméerne, hvor der var divergenser.
English: • The committee considered the identified divergences for the Seroquel and Seroquel XR and associated names regarding the therapeutic indications, posology and method of administration, special warnings and precautions for use, as well as in the remaining sections of the SmPCs
Danish: • udvalget behandlede de konstaterede divergenser i produktinformationen for Seroquel og Seroquel XR og relaterede navne vedrørende afsnittene terapeutiske indikationer, dosering og administration, særlige advarsler og forsigtighedsregler vedrørende brugen samt de øvrige afsnit i produktresuméet,
English: From all the EU MSs in which Seroquel is approved, only one had a different wording from the MRPapproved SmPC by having the following additional text: “treatment of acute and chronic psychosis, including schizophrenia and manic episodes associated with bipolar disorder”.
Danish: Af alle de EU medlemsstater, hvor Seroquel er godkendt, havde kun én en ordlyd, der afveg fra det produktresumé, der var godkendt ved den gensidige anerkendelsesprocedure, idet det indeholdt følgende yderligere tekst: “behandling af akut og kronisk psykose, herunder skizofreni og manisk episode ved bipolær sygdom”.
English: The harmonised wording for this indication is “Treatment of schizophrenia”.
Danish: Den harmoniserede ordlyd af denne indikation er “behandling af skizofreni”.
English: The active metabolite, noraquetapine, shows greater affinity for 5HT2A receptor and is an inhibitor of the norepinephrine transporter.
Danish: Den aktive metabolit, norquetiapin, har større aktivitet for 5HT2Areceptorer og er en hæmmer af noradrenalin-transporteren.
English: The CHMP agreed that this warning included redundant information regarding orthostatic hypotension and related dizziness, since it repeated information already included under subheading on Cardiovascular (now Orthostatic hypotension).
Danish: CHMP fandt, at denne advarsel indeholdt overflødige oplysninger om ortostatisk hypotension og ledsagende svimmelhed, da disse i forvejen var medtaget under overskriften om kardiovaskulære bivirkninger (nu ortostatisk hypotension).
English: the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflets are set out in Annex III for Seroquel and Seroquel XR and associated names (see Annex I).
Danish: anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægssedler fremgår af bilag III for Seroquel og Seroquel XR og relaterede navne (se bilag I).
English: However, the available data are very limited, and therefore it is recommended that a decision must be made whether to discontinue breast-feeding or to discontinue Seroquel therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the mother.
Danish: Der foreligger imidlertid kun meget begrænsede data, hvorfor det skal besluttes at ophøre enten med amningen eller med behandlingen med <X> ud fra fordelene ved amning for barnet og den terapeutiske fordel for moderen.
English: Hepatic Effects
Danish: Leverpåvirkning
English: Three MSs had the following wording: “For the prevention of recurrence in patients with bipolar disorder, in patients whose manic, mixed or depressive episode has responded to quetiapine treatment”, while twenty other MSs had the current MRP-approved SmPC, without the word “mixed”.
Danish: Tre medlemsstater anvendte ordlyden: “Forebyggelse af recidiv ved bipolær sygdom hos patienter, hos hvem den maniske, blandede eller depressive episode har responderet på behandling med quetiapin”, mens 20 andre medlemsstater anvendte ordlyden i det gældende produktresumé fra den gensidige anerkendelsesprocedure, uden ordet “blandet”.
English: Seroquel (quetiapine) and Seroquel XR (quetiapine prolonged released formulation) are used for the treatment of schizophrenia and bipolar disorder, being Seroquel XR also used as an add-on treatment in major depression.
Danish: Seroquel (quetiapin) og Seroquel XR (depotformulering af quetiapin) anvendes til behandling af skizofreni og bipolær sygdom, idet Seroquel XR desuden anvendes som tillægsbehandling ved svær depression.
English: Therefore the harmonised wording for this indication is “Treatment of schizophrenia”.
Danish: Den harmoniserede ordlyd af denne indikation er derfor “behandling af skizofreni”.
English: Therefore, the agreed harmonised text is “for the prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment”.
Danish: Den vedtagne harmoniserede tekst er derfor “forebyggelse af recidiv af manisk eller depressiv episode hos patienter med bipolær sygdom, der tidligere har responderet på behandling med quetiapin”.
English: Therefore, the following wording was added “Patients with intestinal obstruction / ileus should be managed with close monitoring and urgent care”.
Danish: Der blev derfor tilføjet følgende ordlyd: “*Ved tarmobstruktion/ileus kræves tæt overvågning og akut pleje”.
English: In the heading referring to breastfeeding is stated that the degree of excretion in milk is not consistent.
Danish: Under overskriften om amning anføres, at der ikke er samstemmende oplysninger om omfanget af udskillelsen i mælk.
English: • treatment of bipolar disorder o for the treatment of moderate to severe manic episodes in bipolar disorder
Danish: • behandling af bipolær sygdom o behandling af moderat til svær manisk episode ved bipolær sygdom
English: Seroquel XR is indicated as well as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy.
Danish: Seroquel XR er desuden indiceret som tillægsbehandling ved svær depressiv episode hos patienter med svær depressiv sygdom og forudgående suboptimal respons på monoterapi med antidepressiva.
English: o for the prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment.
Danish: o forebyggelse af recidiv af manisk eller depressiv episode hos patienter med bipolær sygdom, der tidligere har responderet på behandling med quetiapin.
English: The final agreed wording is part of the harmonised SmPCs for Seroquel and for Seroquel XR.
Danish: Den endelige vedtagne ordlyd indgår i de harmoniserede produktresuméer for Seroquel og for Seroquel XR.
English: Therefore, the agreed harmonised text is “for the treatment of major depressive episodes in bipolar disorder”.
Danish: Den vedtagne harmoniserede tekst er derfor “behandling af svær manisk episode ved bipolær sygdom”.
English: Seroquel XR wording was disharmonised by one MS in which the following text: “Treatment of Schizophrenia, including preventing relapse in stable schizophrenic patients who have been maintained on Seroquel XR” was omitted in comparison with the MRP SmPC.
Danish: Ordlyden for Seroquel XR afveg hos én medlemsstat, hvor teksten: “Behandling af skizofreni, herunder forebyggelse af recidiv hos patienter med stabil skizofreni, som har været i vedligeholdelsesbehandling med Seroquel XR” blev udeladt ved sammenligning med produktresuméet fra den gensidige anerkendelsesprocedure.
English: The proposed, harmonised text more accurately reflects the current data and knowledge on Seroquel and Seroquel XR.
Danish: Den foreslåede harmoniserede tekst afspejler bedre de nuværende data og den nuværende viden om Seroquel og Seroquel XR.
English: Divergent information was identified in one MS namely with regards to hepatic impairment and paediatric population.
Danish: I én medlemsstat er der konstateret divergerende oplysninger om leverfunktionsnedsættelse og den pædiatriske population.
English: The CHMP had the opportunity to provide comments namely, the CHMP requested the MAH to remove information regarding fatal dose as this is not in line with the SmPC guideline.
Danish: CHMP anmodede i sin kommentar hertil indehaveren af markedsføringstilladelsen om at fjerne oplysningen om fatal dosis, da dette ikke er i overensstemmelse med retningslinjerne for produktresuméer.
English: However, the CHMP requested this warning to be further strengthened with regards the need to manage patients with intestinal obstruction / ileus with close monitoring and urgent care to be added.
Danish: CHMP anmodede imidlertid om yderligere skærpelse af advarslen om nødvendigheden af at behandle tarmobstruktion/ileus, idet der tilføjedes tæt overvågning og akut pleje.
English: This section was updated in format of the adverse reactions listed according to the QRD template.
Danish: Dette afsnit blev ajourført med angivelse af bivirkninger i henhold til QRD-skabelonen.
English: Furthermore, the recommendations for up-titration and for daily dose in some indications i.e. schizophrenia, moderate to severe episodes in bipolar disorder and major depressive episodes in bipolar disorder differed among MSs.
Danish: Desuden var der afvigelser i medlemsstaternes anbefalinger for optitrering og for daglig dosis ved indikationerne skizofreni, moderat til svær episode ved bipolær sygdom og svær depressiv episode ved bipolær sygdom.
English: The CHMP supported the MAH decision that the harmonised wording for this indication would be aligned with the MRPapproved SmPC text i.e. separating the indications “Schizophrenia” and “Manic episodes in bipolar disorder”.
Danish: CHMP støttede markedsføringstilladelsesindehaveren i, at den harmoniserede ordlyd af denne indikation skulle rettes ind efter teksten i det produktresumé, der er godkendt ved den gensidige anerkendelsesprocedure, dvs. med adskillelse af indikationerne “skizofreni” og “manisk episode ved bipolær sygdom”.
English: Hence, these medicinal products were included in the list of products for PI harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC.
Danish: Disse lægemidler er derfor optaget på den liste over produkter med behov for harmonisering af produktinformationen, der i medfør af artikel 30, stk. 2, i direktiv 2001/83/EF er opstillet af CMD(h) (koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - human).
English: Following all the changes in the SmPC there were amendments made to the Package Leaflet.
Danish: Efter de mange ændringer i produktresuméet blev der foretaget en række tilsvarende ændringer af indlægssedlen.