FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Danish: Patienter (og omsorgspersoner) skal tilrådes at søge læge, hvis der opstår tegn på selvmordstanker eller suicidal adfærd.
English: Mania occurs in an illness called “bipolar disorder”.
Danish: Mani forekommer i forbindelse med en sygdom, som kaldes ”bipolær sygdom”.
English: 1.3 Chemical forms and formulations of valproate
Danish: 1.3 Kemiske former og formuleringer af valproat
English: Moreover, no specific safety issues have been identified in studies in which antidepressant co-medication has been used in patients with bipolar disease.
Danish: Desuden har man ikke identificeret nogen specifikke sikkerhedsproblemer i undersøgelser, hvor der samtidig blev givet antidepressive lægemidler til patienter med bipolær lidelse.
English: However, for theoretical reasons slow-release formulations could be advantageous for compliance reasons and also for avoiding high plasma peaks which may be accompanied by frequent adverse effects.
Danish: Teoretisk set kan formuleringer med langsom frigivelse være fordelagtige, når det gælder overensstemmelsen, og også når det gælder om at undgå høje plasmaniveauer, som ledsages af hyppige bivirkninger.
English: The safety and efficacy of {invented name} for the treatment of manic episodes in bipolar disorder have not been evaluated in patients aged less than 18 years.
Danish: Sikkerhed og virkning af {(sær)navn} til behandling af maniske episoder ved bipolær lidelse er ikke blevet evalueret hos patienter under 18 år.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER OG INDLÆGSSEDLER FREMLAGT AF EMEA
English: Following the European Commission Decision the Risk Management Plan should be submitted with any new application for extending the indication regarding the treatment of mania in bipolar disorder.
Danish: Som følge af Europa-Kommissionens afgørelse skal risikostyringsplanen fremsendes sammen med enhver ny ansøgning om udvidelse af indikationen med hensyn til behandling af mani ved bipolær lidelse.
English: Therefore the CHMP recommended that valproate in the indication treatment of acute episodes is restricted to modified-release (solid oral) formulations.
Danish: CHMP anbefalede dog, at valproat til indikationen "behandling af akutte episoder" begrænses til faste orale formuleringer med modificeret frigivelse.
English: After 12 months of treatment following a manic index episode, 41% of patients treated with valproate were still in remission compared to 24% of patients in the lithium group and 13% of patients in the placebo group.
Danish: Efter 12 måneders behandling, der var indledt efter en manisk indeksepisode, var 41 % af de patienter, der blev behandlet med valproat, stadig i bedring sammenlignet med 24 % af patienterne i lithiumgruppen og 13 % af patienterne i placebogruppen.
English: The available studies on the use of valproate to treat patients with bipolar disorder have shown that the drug was generally well tolerated and revealed no unexpected safety concern.
Danish: De foreliggende undersøgelser af brugen af valproat til behandling af patienter med bipolær lidelse viste, at lægemidlet generelt er veltolereret, og de gav ikke anledning til uventede betænkeligheder ved sikkerheden.
English: Dedicated studies have shown that valproate can be used safely in combination with antipsychotic drugs.
Danish: Specifikke undersøgelser har vist, at det er sikkert at anvende valproat sammen med antipsykotiske lægemidler.
English: In most of the EU Member States valproate is also approved (as valproic acid, sodium valproate, valproate semisodium) for the treatment of patients with bipolar disorder (approved in 25 European countries, in 21 countries with a first-line indication).
Danish: I de fleste af EU's medlemsstater er valproat (som valproinsyre, natriumvalproat og seminatriumvalproat) også godkendt til behandling af patienter med bipolær lidelse (valproat er godkendt i 25 europæiske lande, i 21 lande som førstevalgsindikation).
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Amning Spørg din læge eller apoteket til råds, før du tager nogen form for medicin.
English: It was highlighted that although the indication exists in many Member States, sustained efficacy both in acute mania as well as in the prevention of recurrence of mood episodes has not been clearly demonstrated in well designed clinical trials which comply with the requirements of the CPMP Note for Guidance on Clinical Investigation of Medicinal products for the Treatment and Prevention of Bipolar Disorder (CPMP/EWP/567/98).
Danish: Det blev understreget, at selv om indikationen er godkendt i mange medlemsstater, er vedvarende virkning både ved akut mani og i forbindelse med forebyggelse af humørsvingningsepisoders tilbagevenden ikke blevet klart påvist i veltilrettelagte kliniske undersøgelser, som opfylder kravene i CHMP's "Note for Guidance on Clinical Investigation of Medicinal products for the Treatment and Prevention of Bipolar Disorder" (CPMP/EWP/567/98).
English: There is also some evidence for maintenance of effect in treatment of acute mania episode (up to 12 weeks), although the 12 weeks studies lack a placebo arm, which is a deficiency.
Danish: Der er ligeledes en vis dokumentation for virkningens bevarelse ved behandling af akutte maniske episoder (op til 12 uger), selv om 12-ugers undersøgelserne ikke omfatter en placebogruppe, hvilket er en mangel.
English: WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR {Invented name} is a medicine for the treatment of […] and mania.
Danish: VIRKNING OG ANVENDELSE {(Sær)navn} er medicin til behandling af […] og mani.
English: The MAHs should look into their respective safety databases and add the appropriate frequency of occurrence to the above additional adverse events.
Danish: Indehaverne af markedsføringstilladelsen skal konsultere deres respektive sikkerhedsdatabaser og tilføje, hvor hyppigt ovennævnte yderligere bivirkninger forekommer.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: Based on the literature references provided it can be concluded that there is evidence for the efficacy of valproate in the acute treatment of manic episode, which has been demonstrated in placebo controlled studies of three weeks.
Danish: Ud fra de fremlagte litteraturreferencer kan det konkluderes, at der er dokumentation for valproats virkning ved akut behandling af maniske episoder, hvilket er blevet påvist i placebokontrollerede undersøgelser af tre ugers varighed.
English: The evidence of the efficacy of valproate in the treatment of bipolar disorder comes from sixteen randomised, comparative double-blind or open-label clinical trials.
Danish: Evidensen for valproats virkning ved behandling af bipolær lidelse kommer fra 16 randomiserede, komparative, dobbeltblindede eller åbne kliniske undersøgelser.
English: The need for a Risk Management Plan was discussed with the MAHs.
Danish: Behovet for en risikostyringsplan blev drøftet med indehaverne af markedsføringstilladelsen.
English: The treatment of bipolar disorder includes management of the current mood episode and prevention of recurrence of next mood episodes.
Danish: Behandlingen af bipolær lidelse omfatter styring af den aktuelle humørsvingningsepisode og forebyggelse af efterfølgende humørsvingningsepisoders tilbagevenden.
English: A meta-analysis of randomised placebo controlled trials of antiepileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Danish: En meta-analyse af randomiserede, placebokontrollerede forsøg med antiepileptika har også vist en let øget risiko for selvmordstanker og suicidal adfærd.
English: In other words, the conducted studies demonstrate efficacy of valproate in the treatment of acute mania over 21 days, but evidence for the maintenance of the treatment effect up to 12 weeks of treatment is not considered complete.
Danish: De foretagne undersøgelser påviser med andre ord valproats virkning ved behandling af akut mani over 21 dage, men dokumentationen for en bevarelse af behandlingens virkning ved op til 12 ugers behandling betragtes ikke som fuldstændig.
English: 4.6 Pregnancy and lactation
Danish: 4.6 GRAVIDITET OG AMNING
English: Valproic acid passes into the breast milk.
Danish: Valproatsyre udskilles i modermælken.
English: The MAHs for valproate authorised products who apply for the new indication should contact the national competent authorities (NCAs) of the respective member states in order to submit a Risk Management Plan.
Danish: Indehaverne af markedsføringstilladelsen for godkendte lægemidler indeholdende valproat, som ansøger om godkendelse af den nye indikation, skal kontakte de nationale kompetente myndigheder i de respektive medlemsstater med henblik på at fremsende en risikostyringsplan.
English: As conclusion the recurrence prevention of both mania and depression has not been demonstrated.
Danish: Konklusionen er, at forebyggelse af tilbagevenden af mani ikke er blevet påvist.
English: Rua Quinta do PinheiroEdifício Tejo 6° Piso Carnaxide
Danish: Rua Quinta do PinheiroEdifício
English: Evidence of efficacy of valproate in the prevention of mood episodes is thus not completely convincing based on the performed clinical studies alone.
Danish: Dokumentationen for valproats virkning til forebyggelse af humørsvingningsepisoder er således ikke helt overbevisende ud fra de gennemførte kliniske undersøgelser.
English: Following the literature presented as well the post-marketing experience the adverse events of “nausea”, “sedation” and “extrapyrimidal disorders” are proposed to be added to the Section 4.8 “Undesirable effects” of the SPC.
Danish: Ud fra den fremlagte litteratur og erfaringerne efter markedsføringen foreslås det, at bivirkningerne "kvalme", "sedation" og "ekstrapyramidale lidelser" medtages i produktresuméets punkt 4.8 om bivirkninger.
English: No unexpected signals have been identified from post-marketing surveillance.
Danish: Overvågningen efter markedsføringen har ikke vist nogen uventede signaler.
English: The daily dosage should be established and controlled individually by your doctor.
Danish: Den daglige dosis skal fastsættes og kontrolleres individuelt af din læge.
English: On the basis of the evidence available to the PhVWP, it was agreed that SPCs for all antiepileptics across the European Union should be modified with regard to suicidality with the addition of a warning
Danish: På baggrund af den dokumentation, der var tilgængelig for arbejdsgruppen vedrørende lægemiddelovervågning, blev det besluttet, at produktresuméerne for alle antiepileptiske lægemidler i hele EU skal ændres med hensyn til suicidalitet, og at der skal tilføjes en advarsel.
English: CONDITIONS OF THE MARKETING AUTHORISATIONS
Danish: BETINGELSER FOR MARKEDSFØRINGSTILLADELSERNE
English: Therefore, in women envisaging a pregnancy, valproate should not be used for the treatment of manic episodes, unless safer alternatives prove to be ineffective or are not tolerated.
Danish: Derfor må valproat ikke bruges til behandling af maniske episoder hos gravide kvinder eller kvinder, der planlægger at blive gravide, medmindre sikrere alternativer viser sig at være virkningsløse eller ikke tolereres.
English: As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet are set out in Annex III and in accordance to the conditions set out in Annex IV.
Danish: Som følge heraf anbefalede CHMP at opretholde markedsføringstilladelserne for de lægemidler, der er omtalt i bilag I. Ændringerne af de pågældende punkter i produktresuméerne og indlægssedlerne fremgår af bilag III og er i overensstemmelse med betingelserne i bilag IV.
English: In 2008, in light of the results of the US FDA meta-analysis of clinical trial data for antiepileptics, and in light of the spontaneous and literature reports, the PhVWP concluded that any antiepileptic drug may be associated with a low risk of suicidal thoughts and behaviour.
Danish: I lyset af resultaterne af den amerikanske Food and Drug Administrations metaanalyse af kliniske undersøgelsesdata om antiepileptiske lægemidler og i lyset af de spontane indberetninger og indberetninger omtalt i litteraturen konkluderede arbejdsgruppen vedrørende lægemiddelovervågning i 2008, at alle antiepileptiske lægemidler kan være forbundet med en lav risiko for selvmordstanker og selvmordsadfærd.
English: Taking into account that in different EU member States the authorised valproate products may have or not the indication for the bipolar disorder the CHMP has the following proposal:
Danish: I betragtning af, at de godkendte valproatlægemidler i de forskellige EU-medlemsstater muligvis ikke alle omfatter indikationen "bipolær lidelse", foreslår CHMP følgende:
English: In children and adolescents:
Danish: Børn og unge:
English: Women of child-bearing potential have to use effective contraception during treatment.
Danish: Kvinder i den fertile alder skal anvende effektiv kontraception under behandlingen.
English: A specialist doctor (neurologist, neuropaediatrician) should decide upon dose titration, the duration of treatment and withdrawal of Valproinsäure-ratiopharm chrono on an individual basis.
Danish: En speciallæge (i neurologi eller neuropædiatri) skal ved dosistitrering afgøre behandlingens varighed og seponering af [HANDELSNAVN] på individuel basis.
English: According to the CHMP recommendation for Valproate-ratiopharm chrono 300/500 mg Retardtabletten and associated names the indication should be adapted in the following due to the limitations and shortcomings of the data from clinical trials:
Danish: I overensstemmelse med CHMP's anbefaling for lægemidler indeholdende Valproate-ratiopharm chrono 300/500 mg Retardtabletten og tilknyttede navne skal indikationen tilpasses som følger på grund af begrænsningerne og manglerne ved dataene fra de kliniske undersøgelser:
English: If you are a woman of child-bearing age, you have to use effective contraception during treatment.
Danish: Hvis du er en kvinde i den fødedygtige alder, skal du anvende sikker prævention under behandlingen.
English: BEFORE YOU TAKE {INVENTED NAME}
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE {(SÆR)NAVN}
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
Danish: BEGRUNDELSE FOR ÆNDRING AF PRODUKTRESUMEERNE
English: Whereas the Bowden study which was lithium- and placebo- controlled failed to show a statistically significant difference with respect to the primary outcome criterion (time to recurrence of any mood episode), patients treated with valproate had better outcomes on several secondary outcome measures than those treated with lithium or placebo.
Danish: Mens Bowden-undersøgelsen, der var lithium- og placebokontrolleret, ikke påviste en statistisk signifikant forskel, når det gælder det primære effektmål (den tid, der går, inden en humørsvingningsepisode finder sted igen), havde patienter behandlet med valproat bedre resultater med hensyn til adskillige sekundære effektmål end de patienter, der fik lithium eller placebo.
English: In addition, in clinical trials a starting dose of 20 mg sodium valproate/kg body weight has also shown an acceptable safety profile.
Danish: Derudover har en initialdosis på 20 mg natriumvalproat/kg legemsvægt også vist en acceptabel sikkerhedsprofil i kliniske forsøg.
English: Whereas, in the original analysis time to recurrence of any mood episode or depressive episode, respectively was not significantly different in the three treatment groups, post-hoc analyses showed that valproate treated patients dropped out significantly less frequent than placebo treated patients because of a mood episode and due to a depressive episode, respectively, whereas the respective difference was not statistically significant compared to lithium treated patients.
Danish: Mens der i den oprindelige analyse af den tid, der går, inden henholdsvis en humørsvingningsepisode eller depressiv episode finder sted igen, ikke var nogen signifikant forskel i de tre behandlingsgrupper, viste post hoc-analyserne, at patienter, der blev behandlet med valproat, udgik af undersøgelserne som følge af en humørsvingningsepisode i signifikant mindre grad end patienter, der fik placebo, mens den respektive forskel ikke var statistisk signifikant sammenlignet med de lithiumbehandlede patienter.
English: Furthermore, according to clinical practice and the dose recommendations, the daily dose should be adapted individually to the clinical response between a specific dose range and the lowest effective dose should be used in the prevention of recurrence in bipolar disorder.
Danish: I overensstemmelse med klinisk praksis og dosisanbefalingerne skal den daglige dosis desuden tilpasses individuelt til den kliniske respons i et specifikt dosisinterval, og den laveste effektive dosis skal anvendes til forebyggelse af tilbagevenden ved bipolær lidelse.
English: Continuation of treatment of manic episodes in bipolar disorder should be adapted individually using the lowest effective dose.
Danish: Fortsættelse af behandling for maniske episoder ved bipolær lidelse skal tilpasses individuelt med anvendelse af den laveste effektive dosis.
English: POSSIBLE SIDE EFFECTS Nausea, sedation, extrapyramidal disorders.
Danish: 4.8 BIVIRKNINGER Kvalme, sedation, ekstrapyramidale forstyrrelser.
English: The content, objectives and implementation of the RMP should be discussed between the relevant MAH and the NCA and it should be agreed and implemented.
Danish: Risikostyringsplanens indhold, målsætninger og gennemførelse skal drøftes mellem de berørte indehavere af markedsføringstilladelsen og de nationale kompetente myndigheder og dernæst gennemføres.
English: The MAHs should update the Product Information to include the relevant sections as proposed by the CHMP regarding the proposed amended indication for the treatment of mania in bipolar disorder when lithium is contraindicated or not tolerated.
Danish: Indehaverne af markedsføringstilladelsen skal ajourføre produktoplysningerne, så de pågældende punkter medtages således som foreslået af CHMP med hensyn til den foreslåede ændring af indikationen til behandling af mani ved bipolær lidelse, når lithium er kontraindiceret eller ikke tolereres.
English: HOW TO TAKE {INVENTED NAME}
Danish: SÅDAN SKAL DU TAGE {(SÆR)NAVN}
English: Safety
Danish: 2 Sikkerhed
English: In addition, in clinical trials a starting dose of 20 mg <valproate>/kg body weight has also shown an acceptable safety profile.
Danish: Derudover har en initialdosis på 20 mg valproat/kg legemsvægt også vist en acceptabel sikkerhedsprofil i kliniske forsøg.
English: The daily dosage should be established and controlled individually by the treating physician.
Danish: Den daglige dosis skal fastsættes og kontrolleres individuelt af den behandlende læge.
English: The recommended initial daily dose is 750 mg.
Danish: Den anbefalede daglige initialdosis er 750 mg.
English: Concerns were raised by the Netherlands regarding the efficacious and safe use of Valproateratiopharm chrono 300/500 mg Retardtabletten (and associated names) in the acute treatment of manic episodes and the prevention of recurrence of mood episodes in patients with bipolar disorder.
Danish: Nederlandene gav udtryk for betænkeligheder med hensyn til en effektiv og sikker brug af Valproateratiopharm chrono 300/500 mg Retardtabletten (og tilknyttede navne) til akut behandling af maniske episoder og forebyggelse af humørsvingningsepisoders tilbagevenden hos patienter med bipolær lidelse.
English: Preventive treatment of mania will be adapted individually using the lowest effective dose.
Danish: Forebyggende behandling af mani vil tilpasses individuelt med den laveste, effektive dosis.
English: “Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
Danish: "Behandling af maniske episoder ved bipolær lidelse, når lithium er kontraindiceret eller ikke tolereres.
English: Manic episodes in bipolar disorder
Danish: Maniske episoder ved bipolær lidelse
English: Manic episodes in bipolar disorder:
Danish: Maniske episoder ved bipolær lidelse:
English: Children and adolescents under 18 years of age: […] should not be used in children and adolescents under 18 years of age for the treatment of mania.
Danish: Børn og unge under 18 år: […] bør ikke bruges til behandling af mani hos børn og unge under 18 år.
English: Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
Danish: Behandling af maniske episoder ved bipolær lidelse, når lithium er kontraindiceret eller ikke tolereres.
English: The mean daily dose usually ranges between 1000 and 2000 mg <valproate>.
Danish: Den gennemsnitlige daglige dosis ligger sædvanligvis på mellem 1.000 og 2.000 mg valproat.
English: - The Committee considered the referral made under article of Article 6 of Commission Regulation (EC) No 1084/2003, for Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) initiated by The Netherlands.
Danish: - CHMP behandlede den sag, der var indbragt af Nederlandene i henhold til artikel 6 i Kommissionens forordning (EF) nr. 1084/2003 for Valproate-ratiopharm chrono 300/500 mg Retardtabletten (og tilknyttede navne).
English: A small number of people being treated with anti-epileptics such as <active substance> have had thoughts of harming or killing themselves.
Danish: Vær ekstra forsigtig med at tage {(SÆR)NAVN} En lille andel af de personer, som bliver behandlet med epilepsimedicin som for eksempel valproat, har haft tanker om at gøre skade på sig selv eller begå selvmord.
English: In addition the time to recurrence of manic and depression events has not shown differences.
Danish: Desuden viste undersøgelsen af den tid, der går, inden en manisk episode optræder igen, ikke nogen statistisk signifikante forskelle.
English: ANNEX III AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND THE PACKAGE LEAFLET
Danish: BILAG III ÆNDRINGER TIL PRODUKTRESUMÉ OG INDLÆGSSEDDEL
English: The daily dose should be adapted to the clinical response to establish the lowest effective dose for the individual patient.
Danish: Den daglige dosis skal tilpasses den kliniske respons for at fastlægge den laveste, effektive dosis til den enkelte patient.
English: Bipolar disorder is a severe mental disorder characterized by recurrent episodes of mania and depression, which as a recurrent affective illness produces significant distress and dysfunction, ranking among the top 30 causes of worldwide disability.
Danish: Denne tilbagevendende affektive lidelse forårsager væsentlige gener og dysfunktion, og det er en af de 30 hyppigste grunde til funktionstab på verdensplan.
English: - The Committee concluded that Valproate-ratiopharm chrono 300/500 mg Retardtabletten (and associated names) have a positive benefit-risk ratio in the proposed amended indication for the treatment of mania in bipolar disorder when lithium is contraindicated or not tolerated.
Danish: - CHMP konkluderede, at Valproate-ratiopharm chrono 300/500 mg Retardtabletten (og tilknyttede navne) har et positivt benefit/risk-forhold til den foreslåede ændrede indikation til behandling af mani ved bipolær lidelse, når lithium er kontraindiceret eller ikke tolereres.
English: 4.2 Posology and method of administration
Danish: 4.2 DOSERING OG INDGIVELSESMÅDE