FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Pantozol Control
Danish: Andre oplysninger om Pantozol Control:
English: What is the risk associated with Pantozol Control?
Danish: Hvilken risiko er der forbundet med Pantozol Control?
English: Pantozol Control without medical supervision is appropriate.
Danish: CHMP var også af den opfattelse, at adgangen til Pantozol Control uden lægelig overvågning, baseret på erfaringerne med anvendelsen af pantoprazol, er passende.
English: Why has Pantozol Control been approved?
Danish: Hvorfor blev Pantozol Control godkendt?
English: What benefit has Pantozol Control shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Pantozol Control?
English: How has Pantozol Control been studied?
Danish: Hvordan blev Pantozol Control undersøgt?
English: What is Pantozol Control?
Danish: Hvad er Pantozol Control?
English: What is Pantozol Control used for?
Danish: Hvad anvendes Pantozol Control til?
English: How is Pantozol Control used?
Danish: Hvordan anvendes Pantozol Control?
English: How does Pantozol Control work?
Danish: Hvordan virker Pantozol Control?
English: Current Step 4 version dated July 2000.
Danish: Gældende Step 4-version dateret juli 2000.
English: There are limited data on the long term outcomes.
Danish: Data vedrørende langsigtede udfald er begrænsede.
English: The timetable for the implementation of the agreement is set out in Annex V.
Danish: Tidsplanen for gennemførelse af aftalen fremgår af bilag IV.
English: In addition, the CMDh clarified that the study should be conducted in more than one Member State.
Danish: Desuden præciserede CMD(h), at undersøgelsen burde udføres i mere end én medlemsstat.
English: This is a greater risk of major malformations than for the general population, for whom the risk is about 2-3%.
Danish: Risikoen for væsentlige misdannelser er således større end i den almindelige befolkning, hos hvem risikoen er 2-3 %.
English: The incidence of risk appears to be higher with valproate than with other antiepileptics.
Danish: Risikoen synes at være større med valproat end med andre antiepileptika.
English: CMDh agreement
Danish: CMD(h)-aftale
English: - Treatment of primary generalised epileptic seizures, secondary generalised epileptic seizures and partial epileptic seizures;
Danish: − Behandling af primære generaliserede epileptiske anfald, sekundære, generaliserede epileptiske og partielle epileptiske anfald
English: Minor editorial amendments were also introduced in the rest of the product information for clarity.
Danish: Derudover blev der af klarhedshensyn indført mindre redaktionelle ændringer i resten af produktinformationen.
English: The CMDh also proposed a new timeline for the circulation of the DHPC in order to have it available to relevant recipients as soon as possible.
Danish: CMD(h) foreslog desuden en ny frist for udsendelse af DHPC'en, så den snarest muligt blev tilgængelig for de relevante modtagere.
English: The PRAC noted that in some Member States valproate is authorised for the prevention of migraine attacks.
Danish: PRAC bemærkede, at valproat i nogle medlemsstater er godkendt til forebyggelse af migræneanfald.
English: The CMDh included a clarification about the population affected by the recommendations as these are also applicable to female adolescents (aged between 12 to 16-18 years) according to the ICH E11 age classification of the paediatric population10.
Danish: CMD(h) indsatte en præcisering vedrørende den population, der berøres af anbefalingerne, da disse også gælder unge kvinder (fra 12 til 16-18 år) i henhold til ICH E11-aldersklassifikationen af den pædiatriske population10.
English: The continuation of treatment after manic episode could be considered in patients who have responded to valproate for acute mania.
Danish: Fortsættelse af behandlingen efter manisk episode kan overvejes hos patienter, som har responderet på valproat ved akut mani.
English: The exact gestational period of risk for these effects is uncertain and the possibility of a risk throughout the entire pregnancy cannot be excluded.
Danish: Der er usikkerhed om den nøjagtige gestationsperiode, hvor der er risiko for disse effekter, og risiko under hele graviditeten kan ikke udelukkes.
English: Christensen J et al. Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.
Danish: Christensen J et al. Prenatal valproat exposure and risk of autism spectrum disorders and childhood autism.
English: Clinical Investigation of Medicinal Products in the Pediatric Population E11.
Danish: Klinisk undersøgelse af lægemidler hos den pædiatriske population E11 (Clinical Investigation of Medicinal Products in the Pediatric Population E11).
English: The most common types of malformations include neural tube defects, facial dysmorphism, cleft lip and palate, craniostenosis, cardiac, renal and urogenital defects, limb defects (including bilateral aplasia of the radius), and multiple anomalies involving various body systems.
Danish: De hyppigste misdannelser er neuralrørsdefekter, faciale dysmorfoser, hareskår og ganespalte, kraniostenose, kardiale, renale og urogenitale defekter, ekstremitetsdefekter (herunder bilateral radiusaplasi) og multiple anomalier, der omfatter forskellige kropssystemer.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for valproate and related substances-containing medicinal products.
Danish: • Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC) fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for lægemidler indeholdende valproat og relaterede stoffer.
English: - Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
Danish: − Behandling af manisk episode ved bipolær sygdom, når lithium er kontraindiceret eller ikke tolereres.
English: Studies in preschool children exposed in utero to valproate show that up to 30-40% experience delays in their early development such as talking and walking later, lower intellectual abilities, poor language skills (speaking and understanding) and memory problems 2,3,4,5.
Danish: Undersøgelser hos førskolebørn eksponeret in utero for valproat viser, at op til 30-40 % har forsinket tidlig udvikling, således at de taler og går senere, har ringere intellektuelle evner, dårlige sproglige evner (tale og forståelse) og hukommelsesproblemer2,3,4,5.
English: The CMDh also considered the need to review the first part of the package leaflet for clarity reasons.
Danish: CMD(h) overvejede desuden nødvendigheden af at revidere første del af indlægssedlen af klarhedshensyn.
English: This follows the format used in the summary of product characteristics.
Danish: Dette svarer til det format, der er anvendt i produktresuméet.
English: The previous statements warning against the risks associated with valproate during pregnancy were summarised and included in rectangle frame.
Danish: De tidligere advarsler mod risici ved valproat under graviditet blev sammenfattet og forsynet med ramme.
English: The review confirms the already known teratogenic risks associated with the use of valproate in pregnant women.
Danish: I gennemgangen bekræftes de i forvejen kendte teratogene risici ved anvendelse af valproat hos gravide kvinder.
English: Intelligence quotient (IQ) measured in school aged children (age 6) with a history of valproate exposure in utero was on average 7-10 points lower than those children exposed to other antiepileptics.
Danish: Intelligenskvotienten (IQ) hos børn i skolealderen (6 år), der havde været eksponeret for valproat in utero, var i gennemsnit 7-10 point lavere end hos børn eksponeret for andre antiepileptika.
English: Data derived from a meta-analysis (including registries and cohort studies) has shown that 10.73% of children of epileptic women exposed to valproate monotherapy during pregnancy suffer from congenital malformations (95% CI: 8.16 -13.29)1.
Danish: Data fra en metaanalyse (herunder registre og kohorteundersøgelser) har vist, at medfødte misdannelser forekommer hos 10,73 % af børn af epileptiske kvinder, der eksponeres for valproat som monoterapi under graviditet (95 % SI: [8,16-13,29])1.
English: Data have shown that exposure to valproate in utero can have adverse effects on mental and physical development of the exposed children.
Danish: Data har vist, at eksponering for valproat in utero kan have negativ indvirkning på den mentale og fysiske udvikling hos det eksponerede barn.
English: This included the responses submitted by the marketing authorisation holders in writing and at oral explanation, as well as the outcome of the scientific advisory group in neurology.
Danish: Heri indgik markedsføringstilladelsesindehavernes skriftlige besvarelser og mundtlige fremlæggelser samt udtalelsen fra den rådgivende videnskabelige gruppe vedrørende neurologi.
English: The PRAC reviewed all available data from pre-clinical studies, pharmacoepidemiological studies, published literature, spontaneous reports as well as the views of the relevant experts (i.e. in neurology, psychiatry, child neuropsychiatry, obstetrics etc.) on the safety and efficacy of valproate and related substances in female children, women of childbearing potential and pregnant women.
Danish: PRAC gennemgik alle foreliggende data fra prækliniske undersøgelser, farmakoepidemiologiske undersøgelser, den publicerede litteratur, spontane indberetninger samt udtalelser fra de relevante eksperter (dvs. i neurologi, psykiatri, børneneuropsykiatri, obstetrik mv.) om sikkerheden og virkningen af valproat og relaterede stoffer hos pigebørn, kvinder i den fødedygtige alder og gravide kvinder.
English: Although the role of confounding factors cannot be excluded, there is evidence in children exposed to valproate that the risk of intellectual impairment may be independent from maternal IQ6.
Danish: Skønt konfunderende faktorer ikke kan udelukkes, er der evidens for, at risikoen for nedsat intellektuel funktion hos børn eksponeret for valproat kan være uafhængig af moderens IQ6.
English: Intellectual and language functions in children of mothers with epilepsy.
Danish: 4 Thomas SV et al. Intellectual and language functions in children of mothers with epilepsy.
English: The CMDh considered that the timeline for the submission of the drug utililsation study protocol should be extended in order to allow MAHs to perform a joint post-authorisation study (see Annex IV).
Danish: CMD(h) fandt, at fristen for indsendelse af protokollen til undersøgelsen af lægemiddelanvendelse burde forlænges for at give indehaverne af markedsføringstilladelse mulighed for at foretage en fælles undersøgelse efter markedsføringstilladelse (se bilag IV).
English: Available data show an increased incidence of minor and major malformations in children born to mothers treated with valproate and related substances during pregnancy.
Danish: De foreliggende data viser øget forekomst af mindre og større misdannelser hos børn født af mødre, der er behandlet med valproat og relaterede stoffer under graviditeten.
English: Limited data suggests that children exposed to valproate in utero may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD)7,8,9.
Danish: Begrænsede data tyder på, at børn eksponeret for valproat in utero kan have større sandsynlighed for at udvikle symptomer på hyperaktiv opmærksomhedsforstyrrelse (ADHD)7,8,9.
English: However, the CMDh emphasised that the referral procedure focussed on the risks associated with valproate and related substances in pregnant women and women of childbearing potential; the benefit-risk balance of valproate and related substances was assessed only in this subpopulation, and not in the general patient population for all indications.
Danish: CMD(h) understregede dog, at henvisningsproceduren var rettet mod risiciene forbundet med valproat og relaterede stoffer hos gravide kvinder og kvinder i den fødedygtige alder; benefit/risk-forholdet for valproat og relaterede stoffer var kun vurderet hos denne delpopulation, ikke hos hele patientpopulationen til alle indikationer.
English: The PRAC agreed that targeted and appropriate information to healthcare professionals and patients were key to ensure a full understanding of the risks and that appropriate materials should be put in place.
Danish: PRAC tilsluttede sig, at målrettet og korrekt information til sundhedspersoner og patienter var afgørende for at sikre fuldstændigt kendskab til risiciene, og at der bør indføres passende materiale til formålet.
English: 1 - PRAC recommendation
Danish: - PRAC's anbefaling
English: The CMDh, having considered the PRAC recommendation dated 9 October 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, agreed on the variation to the terms of the marketing authorisations of valproate and related substances containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Danish: Efter gennemgang af PRAC's anbefaling af 9. oktober 2014 vedtog CMD(h) i henhold til artikel 107k, stk. 1 og 2, i direktiv 2001/83/EF ændring af betingelserne for markedsføringstilladelserne for lægemidler indeholdende valproat og relaterede stoffer, for hvilke de relevante afsnit af produktresuméet og indlægssedlen er gengivet i bilag III, og for hvilke betingelserne fremgår af bilag IV.
English: The risk is dose dependent but a threshold dose below which no risk exists cannot be established.
Danish: Risikoen er dosisafhængig, men der kan ikke fastlægges en tærskeldosis, hvorunder der ikke er nogen risiko.
English: The PRAC noted that valproate is considered to be an effective drug in the treatment of epilepsy and of manic episode in bipolar disorder, serious conditions that might be life threatening if not adequately controlled.
Danish: PRAC bemærkede, at valproat anses for at være et effektivt middel til behandling af epilepsi og manisk episode ved bipolær sygdom, som er alvorlige sygdomme, der kan være livstruende, hvis de ikke kontrolleres sufficient.
English: Based on clinical data and also the views of the relevant experts it was concluded valproate should remain an option for female patients, but should be reserved for situations when other treatment alternatives have been tried and failed.
Danish: På grundlag af kliniske data og udtalelser fra de relevante eksperter konkluderedes det, at valproat fortsat bør være til rådighed for kvindelige patienter, men bør forbeholdes situationer, hvor andre behandlingsalternativer har været forsøgt uden resultat.
English: The PRAC also imposed a drug utilisation study to assess the effectiveness of the risk minimisation measures and to further characterise the prescribing patterns for valproate.
Danish: PRAC stillede desuden krav om en undersøgelse af lægemiddelanvendelse til vurdering af effektiviteten af risikominimeringsforanstaltningerne og til yderligere karakterisering af ordinationsmønstrene for valproat.
English: • The PRAC recommended further changes to the product information such as warnings and precautions and updated information on the risks related to exposure during pregnancy to better inform the healthcare professionals and women.
Danish: • PRAC anbefalede yderligere ændringer af produktinformationen, såsom advarsler og forsigtighedsregler samt opdaterede oplysninger om risiciene ved eksponering under graviditet, med henblik på bedre oplysning af sundhedspersoner og kvindelige patienter.
English: The Committee, as a consequence, concluded that the benefit-risk balance of valproate and related substances-containing medicinal products, remains favourable subject to the conditions to the marketing authorisations, and taking into account the amendments to the product information, where applicable, and other risk minimisation measures recommended.
Danish: konkluderede udvalget, at benefit/risk-forholdet for lægemidler indeholdende valproat og relaterede stoffer fortsat er positivt under forudsætning af de anbefalede betingelser for markedsføringstilladelserne og, hvor det er relevant, ændringer af produktinformationen samt de øvrige anbefalede risikominimeringsforanstaltninger.
English: Core elements of a direct healthcare professional communication (DHPC) were agreed, together with the timelines for its distribution.
Danish: Hovedelementerne i en direkte meddelelse til sundhedspersoner blev vedtaget samt en tidsplan for udsendelsen heraf.
English: The PRAC noted the concerns raised from patients about a lack of awareness on the risks associated with valproate in utero exposure.
Danish: PRAC noterede sig de bekymringer, der fra patientside var rejst om det manglende kendskab til risiciene ved eksponering for valproat in utero.
English: In addition, the PRAC recommended education materials to be put in place in order to ensure that healthcare professionals and patients are informed about the risks associated with valproate in pregnant women and women of childbearing potential and on the measures necessary to minimise the risk.
Danish: Desuden anbefalede PRAC, er der indføres oplysningsmateriale, som informerer sundhedspersoner og patienter om risiciene ved valproat hos gravide kvinder og kvinder i den fødedygtige alder og om de foranstaltninger, der er nødvendige for at minimere risikoen.
English: In view of the risks of valproate use during pregnancy and the available therapeutic alternatives for the treatment of acute migraine attacks, the PRAC concluded that in prophylaxis of migraine attacks valproate should be contraindicated in pregnancy or in women of childbearing potential who are not using effective methods of contraception.
Danish: På baggrund af risiciene ved anvendelse af valproat under graviditet og de tilgængelige behandlingsalternativer ved akutte migræneanfald konkluderede PRAC, at valproat til forebyggelse af migræneanfald bør være kontraindiceret ved graviditet og hos kvinder i den fødedygtige alder, som ikke bruger sikker prævention.
English: Available data show that children exposed to valproate in utero are at increased risk of autistic spectrum disorder (approximately three-fold) and childhood autism (approximately five-fold) compared with the general study population.
Danish: Der foreligger data, som viser, at børn eksponeret for valproat in utero har ca. tre gange større risiko for forstyrrelser i det autistiske spektrum og ca. fem gange større risiko for autisme i barndommen end den almindelige population, der er undersøgt.
English: • The PRAC also concluded that there was a need for further risk minimisation measures such as educational materials aimed to better inform patients and healthcare professionals on the risks and a drug utilisation study to assess the effectiveness of the proposed risk minimisation measures.
Danish: • PRAC konkluderede desuden, at der er behov for yderligere risikominimeringsforanstaltninger, såsom målrettet oplysningsmateriale med bedre information af patienter og sundhedspersoner om risiciene og en undersøgelse af lægemiddelanvendelse med henblik på vurdering af effektiviteten af de foreslåede risikominimeringsforanstaltninger.
English: The CMDh included a clarification on the use of prolonged release formulation to avoid high peak plasma concentrations in the summary of product characteristics.
Danish: CMD(h) indsatte en præcisering i produktresuméet om anvendelse af depotformuleringen til at undgå høje plasmakoncentrationer.
English: In this respect, the PRAC recommended amendments to the product information, including strengthening of the wording to reflect the current knowledge of risks of developmental disorders and congenital anomalies and communication to healthcare professionals through a direct healthcare professional communication.
Danish: I denne forbindelse anbefalede PRAC ændringer af produktinformationen, herunder skærpelse af ordlyden, så den afspejler den nuværende viden om risiciene for udviklingsforstyrrelser og medfødte misdannelser, og en direkte henvendelse til sundhedspersoner (DHPC).
English: These include a prescriber guide, patient booklet and information ensuring the understanding and the awareness of prescribers and patients on the risks.
Danish: Dette skal omfatte en vejledning til ordinerende læger, en patientfolder og information, der sikrer, at ordinerende læger og patienter er vidende og bevidste om risiciene.
English: The PRAC also confirmed the known risk of congenital anomalies.
Danish: PRAC noterede sig desuden den kendte risiko for medfødte misdannelser.
English: The risk seems to be dose-dependent but a threshold dose below which no risk exists, cannot be established based on available data.
Danish: Risikoen synes at være dosisafhængig, men ud fra de foreliggende data kan der ikke fastlægges en dosis, hvorunder der ikke er nogen risiko.
English: Therefore, the PRAC recommends the variation to the terms of the marketing authorisation for the valproate and related substances containing medicinal products referred to in Annex I, for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation.
Danish: anbefaler PRAC ændring af markedsføringstilladelsen for de lægemidler indeholdende valproat og relaterede stoffer, der er omhandlet i bilag 1, for hvilke de relevante afsnit af produktresuméet, og indlægssedlen fremgår af bilag III til PRAC's 's udtalelse;
English: • The PRAC considered the totality of the data submitted with regard to safety and efficacy in female children, women of childbearing potential and pregnant women treated with valproate and related substances.
Danish: • PRAC tog i betragtning samtlige forelagte data vedrørende sikkerhed hos pigebørn, kvinder i den fødedygtige alder og gravide kvinder ved behandling med valproat og relaterede stoffer.
English: • The PRAC considered that intra-uterine exposure to valproate and related substances is associated with an increased risk of developmental disorders in the offspring.
Danish: PRAC tog i betragtning, at intrauterin eksponering for valproat og relaterede stoffer er forbundet med øget risiko for udviklingsforstyrrelser hos afkommet.
English: Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Danish: Efter at have gennemgået PRAC's anbefaling tilsluttede CMD(h) (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) sig de overordnede videnskabelige konklusioner og begrundelsen for anbefalingen.
English: • The PRAC concluded that valproate and related substances should not be used in female children, women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated in the following indications:
Danish: • PRAC konkluderede, at valproat og relaterede stoffer ikke bør anvendes hos pigebørn, kvinder i den fødedygtige alder og gravide kvinder, medmindre behandlingsalternativer ikke virker eller ikke tolereres ved følgende indikationer:
English: Therefore, the PRAC concluded that valproate and related substances should not be used in female children, women of childbearing potential and pregnant women for the treatment of epilepsy and manic episode in bipolar disorder unless alternatives treatments are ineffective or not tolerated.
Danish: PRAC konkluderede derfor, at valproat og relaterede stoffer ikke bør anvendes til pigebørn, kvinder i den fødedygtige alder eller gravide kvinder til behandling af epilepsi eller manisk episode ved bipolær sygdom, medmindre andre behandlingsalternativer ikke virker eller ikke tolereres.
English: 2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
Danish: - Detaljeret videnskabelig begrundelse for afvigelserne fra PRAC's anbefaling