natgillin/translations-raw huggingface dataset:
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Pantozol Control.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pantozol Control.
De hyppigste bivirkninger ved Pantozol Control (som optræder hos omkring 1 ud af 100 patienter) er diarré og hovedpine.
The most common side effects with Pantozol Control (seen in around 1 patient in 100) are diarrhoea and headache.
Hvis du ønsker yderligere oplysninger om behandling med Pantozol Control, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Pantozol Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Pantozol Control må ikke anvendes af patienter, der er overfølsomme (allergiske) over for pantoprazol, soja eller andre af indholdsstofferne.
Pantozol Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients.
Pantozol Control anvendes til korttidsbehandling af symptomer på syrerefluks hos voksne.
Pantozol Control is used for the short-term treatment of the symptoms of acid reflux in adults.
CHMP konkluderede derfor, at fordelene ved Pantozol Control er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Pantozol Control.
The CHMP therefore decided that Pantozol Control's benefits are greater than its risks and recommended that it be given marketing authorisation.
Pantozol Control svarer til et referencelægemiddel ved navn Pantozol, som allerede er godkendt i Den Europæiske Union (EU).
Pantozol Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Pantozol.
Pantozol Control er et lægemiddel, der indeholder det aktive stof pantoprazol.
Pantozol Control is a medicine that contains the active substance pantoprazole.
Pantozol Control pantoprazol
Pantozol Control pantoprazole
Det aktive stof i Pantozol Control, pantoprazol, er en protonpumpehæmmer.
The active substance in Pantozol Control, pantoprazole, is a proton pump inhibitor.
Den fuldstændige liste over de indberettede bivirkninger ved pantoprazol fremgår af indlægssedlen.
For the full list of all side effects reported with pantoprazole, see the package leaflet.
Referencelægemidlet Pantozol udleveres kun efter recept.
The reference medicine, Pantozol, is only available with a prescription.
Andre oplysninger om Pantozol Control:
Other information about Pantozol Control
Hvilken risiko er der forbundet med Pantozol Control?
What is the risk associated with Pantozol Control?
CHMP var også af den opfattelse, at adgangen til Pantozol Control uden lægelig overvågning, baseret på erfaringerne med anvendelsen af pantoprazol, er passende.
Pantozol Control without medical supervision is appropriate.
Hvorfor blev Pantozol Control godkendt?
Why has Pantozol Control been approved?
Hvilken fordel viser undersøgelserne, at der er ved Pantozol Control?
What benefit has Pantozol Control shown during the studies?
Hvordan blev Pantozol Control undersøgt?
How has Pantozol Control been studied?
Hvad er Pantozol Control?
What is Pantozol Control?
Hvad anvendes Pantozol Control til?
What is Pantozol Control used for?
Hvordan anvendes Pantozol Control?
How is Pantozol Control used?
Hvordan virker Pantozol Control?
How does Pantozol Control work?
Gældende Step 4-version dateret juli 2000.
Current Step 4 version dated July 2000.
Data vedrørende langsigtede udfald er begrænsede.
There are limited data on the long term outcomes.
Tidsplanen for gennemførelse af aftalen fremgår af bilag IV.
The timetable for the implementation of the agreement is set out in Annex V.
Desuden præciserede CMD(h), at undersøgelsen burde udføres i mere end én medlemsstat.
In addition, the CMDh clarified that the study should be conducted in more than one Member State.
Risikoen for væsentlige misdannelser er således større end i den almindelige befolkning, hos hvem risikoen er 2-3 %.
This is a greater risk of major malformations than for the general population, for whom the risk is about 2-3%.
Risikoen synes at være større med valproat end med andre antiepileptika.
The incidence of risk appears to be higher with valproate than with other antiepileptics.
CMD(h)-aftale
CMDh agreement
− Behandling af primære generaliserede epileptiske anfald, sekundære, generaliserede epileptiske og partielle epileptiske anfald
- Treatment of primary generalised epileptic seizures, secondary generalised epileptic seizures and partial epileptic seizures;
Derudover blev der af klarhedshensyn indført mindre redaktionelle ændringer i resten af produktinformationen.
Minor editorial amendments were also introduced in the rest of the product information for clarity.
CMD(h) foreslog desuden en ny frist for udsendelse af DHPC'en, så den snarest muligt blev tilgængelig for de relevante modtagere.
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.
PRAC bemærkede, at valproat i nogle medlemsstater er godkendt til forebyggelse af migræneanfald.
The PRAC noted that in some Member States valproate is authorised for the prevention of migraine attacks.
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.
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.
Fortsættelse af behandlingen efter manisk episode kan overvejes hos patienter, som har responderet på valproat ved akut mani.
The continuation of treatment after manic episode could be considered in patients who have responded to valproate for acute mania.
Der er usikkerhed om den nøjagtige gestationsperiode, hvor der er risiko for disse effekter, og risiko under hele graviditeten kan ikke udelukkes.
The exact gestational period of risk for these effects is uncertain and the possibility of a risk throughout the entire pregnancy cannot be excluded.
Christensen J et al. Prenatal valproat exposure and risk of autism spectrum disorders and childhood autism.
Christensen J et al. Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.
Klinisk undersøgelse af lægemidler hos den pædiatriske population E11 (Clinical Investigation of Medicinal Products in the Pediatric Population E11).
Clinical Investigation of Medicinal Products in the Pediatric Population E11.
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.
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.
• 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.
• 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.
− Behandling af manisk episode ved bipolær sygdom, når lithium er kontraindiceret eller ikke tolereres.
- Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated.
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.
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.
CMD(h) overvejede desuden nødvendigheden af at revidere første del af indlægssedlen af klarhedshensyn.
The CMDh also considered the need to review the first part of the package leaflet for clarity reasons.
Dette svarer til det format, der er anvendt i produktresuméet.
This follows the format used in the summary of product characteristics.
De tidligere advarsler mod risici ved valproat under graviditet blev sammenfattet og forsynet med ramme.
The previous statements warning against the risks associated with valproate during pregnancy were summarised and included in rectangle frame.
I gennemgangen bekræftes de i forvejen kendte teratogene risici ved anvendelse af valproat hos gravide kvinder.
The review confirms the already known teratogenic risks associated with the use of valproate in pregnant women.
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.
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.
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.
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.
Data har vist, at eksponering for valproat in utero kan have negativ indvirkning på den mentale og fysiske udvikling hos det eksponerede barn.
Data have shown that exposure to valproate in utero can have adverse effects on mental and physical development of the exposed children.
Heri indgik markedsføringstilladelsesindehavernes skriftlige besvarelser og mundtlige fremlæggelser samt udtalelsen fra den rådgivende videnskabelige gruppe vedrørende neurologi.
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.
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.