natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
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.
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). 
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).
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. 
Available data show an increased incidence of minor and major malformations in children born to mothers treated with valproate and related substances during pregnancy.
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. 
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.
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. 
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.
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. 
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.
- PRAC's anbefaling 
1 - PRAC recommendation
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. 
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.
Risikoen er dosisafhængig, men der kan ikke fastlægges en tærskeldosis, hvorunder der ikke er nogen risiko. 
The risk is dose dependent but a threshold dose below which no risk exists cannot be established.
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. 
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.
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. 
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.
PRAC stillede desuden krav om en undersøgelse af lægemiddelanvendelse til vurdering af effektiviteten af risikominimeringsforanstaltningerne og til yderligere karakterisering af ordinationsmønstrene for valproat. 
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.
• 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. 
• 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.
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. 
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.
Hovedelementerne i en direkte meddelelse til sundhedspersoner blev vedtaget samt en tidsplan for udsendelsen heraf. 
Core elements of a direct healthcare professional communication (DHPC) were agreed, together with the timelines for its distribution.
PRAC noterede sig de bekymringer, der fra patientside var rejst om det manglende kendskab til risiciene ved eksponering for valproat in utero. 
The PRAC noted the concerns raised from patients about a lack of awareness on the risks associated with valproate in utero exposure.
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. 
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.
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. 
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.
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. 
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.
• 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. 
• 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.
CMD(h) indsatte en præcisering i produktresuméet om anvendelse af depotformuleringen til at undgå høje plasmakoncentrationer. 
The CMDh included a clarification on the use of prolonged release formulation to avoid high peak plasma concentrations in the summary of product characteristics.
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). 
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.
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. 
These include a prescriber guide, patient booklet and information ensuring the understanding and the awareness of prescribers and patients on the risks.
PRAC noterede sig desuden den kendte risiko for medfødte misdannelser. 
The PRAC also confirmed the known risk of congenital anomalies.
Risikoen synes at være dosisafhængig, men ud fra de foreliggende data kan der ikke fastlægges en dosis, hvorunder der ikke er nogen risiko. 
The risk seems to be dose-dependent but a threshold dose below which no risk exists, cannot be established based on available data.
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; 
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.
• 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. 
• 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.
PRAC tog i betragtning, at intrauterin eksponering for valproat og relaterede stoffer er forbundet med øget risiko for udviklingsforstyrrelser hos afkommet. 
• The PRAC considered that intra-uterine exposure to valproate and related substances is associated with an increased risk of developmental disorders in the offspring.
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. 
Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
• 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: 
• 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:
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. 
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.
- Detaljeret videnskabelig begrundelse for afvigelserne fra PRAC's anbefaling 
2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
• PRAC konkluderede, at valproat og relaterede stoffer bør være kontraindiceret til forebyggelse af migræneanfald under graviditet og hos kvinder i den fødedygtige alder, som ikke anvender sikker prævention under behandlingen med valproat. 
• The PRAC concluded that valproate and related substances should be contraindicated in prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate.
Desuden tog PRAC de synspunkter i betragtning, der var udtrykt af patienter, familier og omsorgsgivere, og sundhedspersoners syn på kendskabet til og bevidstheden om risiciene ved eksponering in utero for valproat. 
In addition, the PRAC considered the views of patients, families and carers, and the views of healthcare professionals for the understanding and the awareness of the risks associated with valproate in utero exposure.
I anbefalingen blev der desuden taget hensyn til udtalelser fra patienter, familier og omsorgsgivere samt sundhedspersoners syn på konsekvenserne af, kendskabet til og bevidstheden om risiciene ved in utero-eksponering for valproat. 
In addition, the views of patients, families and carers, and the view of healthcare professionals regarding the implications, the understanding and awareness of the risks associated with valproate in utero exposure were taken into account in the recommendation.
Videnskabelige konklusioner og begrundelse for ændring af markedsføringstilladelserne på visse betingelser samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering) 
Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations subject to conditions and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
CMD(h) (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) har gennemgået nedenstående anbefaling fra PRAC for lægemidler indeholdende valproat og relaterede stoffer: 
The CMDh considered the below PRAC recommendation with regard to valproate and related substances-containing medicinal products:
Europa-Kommissionen traf en afgørelse den 30. marts 2010. 
The European Commission issued a decision on 30 March 2010.
Dr. Harald Enzmann (Tyskland) 
Dr Harald Enzmann (Germany)
Dr. Robert James Hemmings (Det Forenede Kongerige) 
Dr Robert James Hemmings (United Kingdom)
London, den 30. marts 2010 Dok. 
London, 30 March 2010 Doc.
Co-rapportør(er): 
Co-rapporteur(s):
Disse medlemsstater kunne imidlertid ikke nå til enighed, og den svenske lægemiddelkontrolmyndighed henviste sagen til CHMP til voldgift den 30. juli 2009. 
However, the member states were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 30 July 2009.
Bioækvivalensundersøgelser anvendes til at sammenligne, hvordan et generisk lægemiddel optages i kroppen i forhold til referencelægemidlet. 
Bioequivalence studies are used to compare how a generic medicine is absorbed by the body in comparison to the reference medicine.
Spørgsmål og svar vedrørende indbringelsesproceduren for Pantoprazole Bluefish pantoprazol 20- og 40-mg tabletter 
Questions and answers on the referral for Pantoprazole Bluefish pantoprazole 20 and 40 mg tablets
Det Europæiske Lægemiddelagentur har afsluttet en voldgiftsprocedure som følge af uenighed blandt Den Europæiske Unions medlemsstater om godkendelsen af lægemidlet Pantoprazole Bluefish. 
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Bluefish.
På basis af en vurdering af de tilgængelige data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at Pantoprazole Bluefish havde vist sig at være bioækvivalent med referencelægemidlet, og at der kunne udstedes markedsføringstilladelse i Sverige og alle de berørte medlemsstater. 
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Pantoprazole Bluefish had been shown to be bioequivalent to the reference medicine, and therefore the marketing authorisation should be granted in Sweden and all concerned member states.
Ved at blokere pumperne reducerer pantoprazol syreproduktionen. 
By blocking the pumps, pantoprazole reduces acid production.
Disse tabletter passerer gennem maven og bliver først nedbrudt, når de når ned i tarmene. 
These are tablets that pass through the stomach without being broken down until they reach the intestine.
Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Sverige) vurderer et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, som gælder både nationalt og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Østrig, Danmark, Tyskland, Finland, Frankrig, Ungarn, Irland, Italien, Nederlandene, Polen, Portugal og Spanien samt Norge). 
This is a procedure when one Member State (the ‘reference Member State', in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Austria, Denmark, Germany, Finland, France, Hungary, Ireland, Italy, the Netherlands, Norway, Poland, Portugal and Spain).
Begrundelsen for indbringelsen var, at de nederlandske, tyske, irske og italienske lægemiddelkontrolmyndigheder havde givet udtryk for betænkeligheder vedrørende den bioækvivalensundersøgelse, hvor Pantoprazole Bluefish og Pantecta var blevet sammenlignet. 
The grounds for the referral were concerns expressed by the Dutch, German, Irish and Italian medicines regulatory agencies regarding the bioequivalence study comparing Pantoprazole Bluefish and Pantecta.
EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved Pantoprazole Bluefish opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Sverige og i EU-medlemsstaterne Østrig, Danmark, Tyskland, Finland, Frankrig, Ungarn, Irland, Italien, Nederlandene, Polen, Portugal og Spanien samt Norge. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Bluefish outweigh its risks, and the marketing authorisation can be granted in Sweden and in the following Member States of the European Union, Austria, Denmark, Germany, Finland, France, Hungary, Ireland, Italy, the Netherlands, Poland, Portugal, Spain as well as in Norway.
20-mg-tabletterne kan anvendes ved reflukssygdom til behandling af symptomer som f.eks. halsbrand og sure opstød, langtidsbehandling og forebyggelse af tilbagefald af refluksøsofagitis (betændelse i spiserøret forårsaget af syre) og forebyggelse af mavesår, som kan være forårsaget af visse lægemidler mod smerter og betændelse kaldet ikke-selektive, ikke-steroide antiinflammatoriske lægemidler (NSAID'er), når patienten har behov for fortsat NSAID-behandling. 
The 20 mg tablets can be used for reflux disease to treat symptoms such as heartburns and acid regurgitation (acid flowing up in the mouth), for the long-term management and prevention of relapse in reflux oesophagitis (inflammation of the gullet, due to acid), for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.
Bluefish Pharmaceuticals AB indgav en ansøgning for Pantoprazole Bluefish til Sveriges lægemiddelkontrolmyndighed med henblik på en decentral procedure. 
Bluefish Pharmaceuticals AB submitted Pantoprazole Bluefish to the Swedish medicines regulatory agency for a decentralised procedure.
Det virker ved at blokere "protonpumperne", som er proteiner i specialiserede celler i mavesækkens slimhinde, der pumper syre ind i maven. 
It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Hvad er Pantoprazole Bluefish? 
What is Pantoprazole Bluefish?
Pantoprazole Bluefish er et lægemiddel, der anvendes til behandling af sygdomme, hvor der produceres for meget syre i maven. 
Pantoprazole Bluefish is a medicine used to treat diseases where the stomach produces too much acid.
40-mg-tabletterne kan anvendes til sværere syrerelaterede sygdomme som f.eks. mavesår, duodenalsår og Zollinger-Ellison-syndrom (en tilstand, der skyldes oversekretion af syre i maven), og kan hjælpe med at udrydde en bakterie i maven kaldet Helicobacter pylori, som man ved kan forårsage mavesår. 
The 40 mg tablets can be used for more severe acid diseases such as stomach ulcer, duodenal ulcer, Zollinger-Ellison syndrome (a condition caused by oversecretion of acid in the stomach) and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcer.
Hvorfor blev Pantoprazole Bluefish vurderet igen? 
Why was Pantoprazole Bluefish reviewed?
Pantoprozole Bluefish er et generisk lægemiddel, der er baseret på referencelægemidlet Pantecta. 
Pantoprozole Bluefish is a generic medicine based on the reference medicine Pantecta.
Det aktive stof i Pantoprazole Bluefish, pantoprazol, er en protonpumpehæmmer. 
The active substance in Pantoprazole Bluefish, pantoprazole, is a proton pump inhibitor.
Pantoprazole Bluefish fås som enterotabletter. 
Pantoprazole Bluefish is presented as gastro-resistant tablets.
21. september 2009, 26. oktober 2009 
Company responses provided on: 21 September 2009, 26 October 2009 Opinion date:
Denne oversigt blev sidst ajourført i 04-2018. 
This overview was last updated in 04-2018.