FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC nevertheless considered appropriate that further studies be performed to document the efficacy of domperidone in children in this indication and in the newly recommended posology.
Danish: PRAC fandt det dog hensigtsmæssigt med yderligere undersøgelser til dokumentation af virkningen af domperidon til denne indikation til børn ved den nye anbefalede dosering.
English: For all indications other than “relief of symptoms of nausea and vomiting”, there is extremely limited evidence of efficacy of domperidone, and therefore the potential benefits are considered to be outweighed by the identified cardiac risk.
Danish: Til alle indikationer bortset fra »lindring af symptomerne ved kvalme og opkastning« er evidensen for virkningen af domperidon ekstremt begrænset, hvorfor de potentielle fordele anses for at opvejes af den fundne kardiale risiko.
English: • The dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-oesophageal reflux, and oesophagitis:
Danish: • Det dyspeptiske symptomkompleks, der ofte optræder sammen med forsinket ventrikeltømning, gastroøsofageal refluks og øsofagitis:
English: The CMDh considered the request from one MAH with regards to the timelines to fulfil some of the conditions as proposed by the PRAC.
Danish: CMD(h) tog hensyn til anmodningen fra den ene markedsføringstilladelsesindehaver vedrørende tidsfristen for opfyldelse af visse af de betingelser, der var fremsat af PRAC.
English: The CMDh, having considered the PRAC recommendation dated 6 March 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation or revocation as applicable of the marketing authorisations of domperidone-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 6. marts 2014 i henhold til artikel 107k, stk. 1 og 2, i direktiv 2000/83/EF tog CMD(h) stilling til ændring eller i givet fald inddragelse af markedsføringstilladelserne for lægemidler indeholdende domperidon, for hvilke de relevante afsnit af produktresuméet og indlægssedlen er gengivet i bilag III, og betingelserne fremgår af bilag IV.
English: The risks are increased in patients who are over 60 years of age, who are using high doses and/or who are using concomitant QT-prolonging drugs or products that can increase plasma levels of domperidone.
Danish: Risiciene er øget hos patienter over 60 år, som anvender høje doser og/eller samtidig får QT-forlængende lægemidler eller lægemidler, der kan øge plasmakoncentrationen af domperidon.
English: • The PRAC considered that domperidone is associated with an increased risk of serious cardiac adverse drug reaction, including QT prolongation and sudden cardiac death.
Danish: • PRAC fandt, at domperidon er forbundet med øget risiko for alvorlige kardiale bivirkninger, herunder QT-forlængelse og pludselig kardial død.
English: It should also be contraindicated in patients with moderate to severe hepatic impairment and in co-administration with potent CYP3A4 inhibitors, due to the expected increase in plasma levels of domperidone.
Danish: Domperidon bør ligeledes være kontraindiceret ved moderat til svær leverfunktionsnedsættelse og ved koadministration af potente CYP3A4-hæmmere på grund af den forventede højere plasmakoncentration af domperidon.
English: • The PRAC considered that the pharmacokinetic data supporting the rectal formulations is limited, and therefore recommended that further data be generated to allow for a comparison between the oral and rectal formulations.
Danish: • PRAC fandt, at de farmakokinetiske data til støtte for de rektale formuleringer er begrænsede, og anbefalede derfor, at der genereres yderligere data, der gør det muligt at sammenligne de orale og rektale formuleringer,
English: The PRAC also considered that the combination domperidone/cinnarizine, which contains 15 mg domperidone (higher than the newly recommended individual dose), has a negative benefit-risk balance.
Danish: PRAC fandt desuden, at kombinationen domperidon/cinnarizin, der indeholder 15 mg domperidon (mere end den anbefalede nye enkeltdosis) har negativt risk/benefit-forhold.
English: Procedure on Domperidone the CMDh confirmed that the benefit-risk ratio for indication ‘relief of the symptoms of nausea and vomiting' (including in the paediatric population) remains positive.
Danish: Med henvisning til Kommissionens beslutning vedrørende artikel 30-proceduren for domperidon bekræftede CMD(h), at benefit/riskforholdet for indikationerne »lindring af kvalme og opkastning« (også hos den pædiatriske population) fortsat er positivt.
English: • Extend the timeframe for the submission of the final study report on condition 2 (pharmacokinetic study to generate data to allow for a comparison between the rectal and oral formulations).
Danish: • forlængelse af fristen for indsendelse af slutrapporten om undersøgelsen vedrørende betingelse 2 (farmakokinetisk undersøgelse til sammenligning af de rektale og orale formuleringer),
English: • The PRAC considered that the data supporting the efficacy of domperidone in the paediatric population are limited and recommended that further data be generated to confirm the efficacy in this patient population.
Danish: • PRAC fandt, at dataene til støtte for virkningen af domperidon hos den pædiatriske population er begrænsede, og anbefalede, at der genereres yderligere data til at bekræfte virkningen hos denne patientpopulation,
English: Domperidone is authorised also as a fixed-dose combination product with cinnarizine and indicated for the prevention and treatment of symptoms associated with motion sickness.
Danish: Domperidon er desuden godkendt i en fastdosiskombination med cinnarizin og er indiceret til forebyggelse og behandling af symptomer ved transportsyge.
English: • The PRAC was of the opinion that existing data, although limited, are indicative of efficacy in the indication ‘relief of symptoms of nausea and vomiting'.
Danish: • PRAC fandt, at de eksisterende data, skønt de er begrænsede, viser virkning ved indikationen »symptomatisk lindring af kvalme og opkastning«,
English: − rectal formulations dosed at 10 mg and 60 mg
Danish: − rektale formuleringer i styrkerne 10 mg og 60 mg
English: • The PRAC considered the totality of the data submitted in support of the safety and efficacy of domperidone.
Danish: • PRAC vurderede samtlige forelagte data om virkningen og sikkerheden af domperidon,
English: Scientific conclusions and grounds for revocation or variation to the terms of the marketing authorisations, as applicable, and detailed explanation for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner og begrundelse for inddragelse eller i givet fald ændring af markedsføringstilladelserne samt detaljeret redegørelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering)
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) (koordinationsgruppe vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) sig de overordnede videnskabelige konklusioner og begrundelsen for anbefalingen.
English: It is used in the treatment of symptoms of nausea and vomiting of variable origin.
Danish: Det anvendes til symptomatisk behandling af kvalme og opkastning af forskellig årsag.
English: The PRAC also noted that the rectal formulations dosed at 10 mg and approved for paediatric use do not allow for the recommended dose adjustment according to body weight, and therefore are likely to result in exposing paediatric patients to a dose higher than the newly recommended.
Danish: PRAC bemærkede desuden, at de rektale 10 mg formuleringer, der er godkendt til pædiatrisk brug, ikke giver mulighed for den anbefalede dosisjustering i henhold til legemsvægt og derfor må forventes at ville udsætte pædiatriske patienter for højere dosis end den nye anbefalede.
English: • The PRAC noted that, in the combination domperidone/cinnarizine, domperidone is dosed at a 15 mg which is higher than the newly recommended individual dose.
Danish: • PRAC bemærkede, at kombinationen domperidon/cinnarizin indeholder 15 mg domperidon, hvilket er højere end den anbefalede nye enkeltdosis.
English: Off-label use of domperidone is known to exist for conditions such as GERD, gastroparesis and stimulation of lactation.
Danish: Ikke godkendt anvendelse af domperidon vides at finde sted til lidelser såsom gastroøsofageal reflukssygdom, gastroparese og stimulation af laktation.
English: • The PRAC noted that the rectal formulations approved for paediatric use do not allow for the necessary recommended dose adjustment according to body weight, and therefore are likely to result in exposing paediatric patients to a dose higher than recommended.
Danish: • PRAC bemærkede, at de rektale formuleringer, der er godkendt til pædiatrisk brug, ikke giver mulighed for den anbefalede dosisjustering i henhold til legemsvægt og derfor må forventes at ville udsætte pædiatriske patienter for højere dosis end den nye anbefalede,
English: The data in support of the paediatric use in relief of symptoms of nausea and vomiting is limited.
Danish: Der er begrænsede data til dokumentation af pædiatrisk anvendelse til lindring af kvalme og opkastning.
English: • The PRAC was also of the opinion that existing data on the efficacy of domperidone in indications other than ‘relief of symptoms of nausea and vomiting' are very limited, and therefore the potential benefit is outweighed by the cardiac risk.
Danish: • PRAC fandt desuden, at der kun er meget begrænsede data om virkningen af domperidon ved andre indikationer end »symptomatisk lindring af kvalme og opkastning«, hvorfor den potentielle fordel opvejes af den kardiale risiko,
English: The PRAC, as a consequence, concluded that the benefit-risk balance of domperidone-containing medicinal products remains favourable subject to the conditions to the marketing authorisations, and taking into account the amendments to the product information and other risk minimisation measures recommended.
Danish: Orale væskeformige formuleringer skal leveres med en egnet doseringsanordning, konkluderede PRAC, at benefit/risk-forholdet for lægemidler indeholdende domperidon fortsat er positivt under forudsætning af de anbefalede betingelser for markedsføringstilladelserne og ændringer af produktinformationen samt de øvrige anbefalede risikominimeringsforanstaltninger.
English: Domperidone-containing medicines are available as over-the-counter (OTC) or prescription-only medicines (POM).
Danish: Lægemidler indeholdende domperidon fås som håndkøbsmedicin og som receptpligtig medicin.
English: • In view of the available data the PRAC concluded, subject to the amendments to the product information and implementation of other risk minimisation measures, that the benefit-risk balance of domperidone-containing products:
Danish: • af de foreliggende data konkluderede PRAC, at under forudsætning af ændringer i produktinformationen og andre risikominimeringsforanstaltninger er benefit/risk-forholdet for lægemidler indeholdende domperidon: o positivt til lindring af symptomerne ved kvalme og opkastning,
English: Domperidone is not approved in all Member States for paediatric use in the subpopulation under 12 years of age and adolescents weighing <35 kg.
Danish: Domperidon er ikke godkendt i alle medlemsstater til pædiatrisk anvendelse hos populationen under 12 år eller unge <35 kg. Hvor en sådan godkendelse foreligger, ses den aktuelt godkendte dosering at variere fra 0,25 til 0,5 mg/kg 3 til 4 gange dagligt.
English: Subsequently, cardiovascular events including risk of QT-prolongation, arrhythmia and sudden cardiac death in association with other pharmaceutical forms of domperidone have since been discussed at the European level by the Pharmacovigilance Working Party (PhVWP).
Danish: Efterfølgende har arbejdsgruppen vedrørende lægemiddelovervågning (PhVWP) på europæisk plan drøftet kardiovaskulære hændelser knyttet til andre lægemiddelformer af domperidon, herunder risikoen for QT-forlængelse, arytmier og pludselig kardial død.
English: The CMDh considered the below PRAC recommendation with regards to domperidone-containing medicinal products:
Danish: CMD(h) (koordinationsgruppe vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) har gennemgået nedenstående anbefaling fra PRAC for lægemidler indeholdende domperidon:
English: o Is not favourable for high dose rectal formulations (60 mg) or rectal formulations approved for paediatric use (10 mg).
Danish: • af de foreliggende data konkluderede PRAC desuden, at benefit/risk-forholdet for lægemidler indeholdende domperidon: o ikke er positivt til de øvrige godkendte indikationer, o ikke er positivt for orale højdosisformuleringer (over 10 mg), o ikke er positivt for rektale højdosisformuleringer (60 mg) eller rektale formuleringer godkendt til pædiatrisk anvendelse (10 mg), o ikke er positivt til kombination domperidon/cinnarizin, anbefaler PRAC i medfør af artikel 116 i direktiv 2001/83/EF:
English: Cmax is reached after 10-16 hours.
Danish: Cmax nås efter 10-16 timer.
English: These reactions are not in themselves an indication of sensitisation.
Danish: Disse reaktioner er ikke i sig selv et tegn på overfølsomhed.
English: Diagnosis should be made according to current guidelines.
Danish: Diagnosen bør stilles i henhold til de gældende retningslinjer.
English: 2 years
Danish: 2 år
English: Use in children and adolescents
Danish: Brug til børn og teenagere
English: Population/Visit
Danish: Population/Besøg
English: You may require medical attention.
Danish: Det kan være nødvendigt med lægebehandling.
English: Patients with clinically significant response (%)
Danish: Patienter med klinisk signifikant respons (%)
English: The clinical benefit of rivastigmine should be reassessed on a regular basis.
Danish: Den kliniske fordel af rivastigmin bør revurderes regelmæssigt.
English: - The patch can be used in everyday situations, including bathing and during hot weather.
Danish: - Plasteret kan anvendes i hverdagssituationer, herunder badning og varmt vejr.
English: Rivastigmine should not be used during pregnancy unless clearly necessary.
Danish: Rivastigmin bør ikke anvendes under graviditet, medmindre det er klart nødvendigt.
English: Clinical studies in Alzheimer's dementia
Danish: Kliniske studier af Alzheimers demens
English: These adverse reactions occur more commonly in women.
Danish: Disse bivirkninger forekommer hyppigere hos kvinder.
English: In massive overdose, atropine can be used.
Danish: Ved massiv overdosering kan atropin anvendes.
English: The in vivo micronucleus test was negative.
Danish: In vivo-micronucleus-testen var negativ.
English: United Kingdom Tel: +44 (0)1509 611611
Danish: Storbritannien Tel: +44 (0)1509 611611
English: Make sure the patch does not loosen during these activities.
Danish: Sørg for, at depotplasteret ikke løsner sig under disse aktiviteter.
English: Dehydration can be associated with serious outcomes.
Danish: Dehydrering kan få alvorlige følger.
English: Rivastigmine is weakly bound to plasma proteins (approximately 40%).
Danish: Rivastigmin bindes svagt til plasmaproteiner (ca. 40%).
English: solarium) for long periods of time.
Danish: solarium) i længere tid.
English: • Additional risk minimisation measures
Danish: • Yderligere risikominimeringsforanstaltninger
English: Possible dose adjustments or temporarily stopping treatment can be considered if needed.
Danish: Mulige dosisjusteringer eller midlertidig standsning af behandlingen kan overvejes, hvis det findes nødvendigt.
English: 2 Based on CMH test (van Elteren test) blocking for country.
Danish: 2 Baseret på CMH-testblokning (van Elteren-test) for land.
English: Specific dermal studies in pregnant animals have not been conducted.
Danish: Der er ikke udført specifikke dermale studier på gravide dyr.
English: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia.
Danish: Behandlingen bør indledes og overvåges af en læge, der har erfaring med diagnosticering og behandling af Alzheimers demens.
English: - Bathing, swimming or showering should not affect the patch.
Danish: - Badning, svømning eller brusebad påvirker ikke plasteret.
English: Activity of the enzyme returns to baseline levels about 9 hours after the maximum inhibitory effect has been achieved.
Danish: Enzymets aktivitet er tilbage på baseline-niveau ca. 9 timer efter, at den maksimale hæmmende effekt er opnået.
English: If you feel faint or confused do not drive, use machines or perform any other tasks that require your attention.
Danish: Hvis du føler dig svag eller konfus, skal du lade være med at køre bil, betjene maskiner eller gøre andet, som kræver opmærksomhed.
English: - if you have a low body weight.
Danish: - hvis din kropsvægt er lav.
English: It readily crosses the blood-brain barrier and has an apparent volume of distribution in the range of 1.8-2.7 l/kg.
Danish: Det krydser let blod-hjerne-barrieren og har et tilsyneladende fordelingsvolumen på 1,8-2,7 l/kg.
English: United Kingdom
Danish: Storbritannien
English: The pouch can be torn open in two places.
Danish: Brevet kanåbnes to steder.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83 and published on the European medicines web-portal
Danish: Indehaveren af markedsføringstilladelsen skal imidlertid fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel, såfremt lægemidlet bliver inkluderet på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.
Danish: Du kan eksperimentere med forskellige placeringer, når du sætter et nyt plaster på, for at finde de steder, som er mest behagelige for dig, og hvor tøjet ikke gnider mod plasteret.
English: Discontinuation should also be considered when evidence of a therapeutic effect at the optimal dose is no longer present.
Danish: Seponering bør også overvejes, når der ikke længere er tegn på terapeutisk effekt ved den optimale dosis.
English: N is the number of patients with an assessment at baseline (last assessment in the initial open-label phase) and with at least 1 post-baseline assessment (for the LOCF).
Danish: N er antal af patienter med vurdering ved baseline (sidste vurdering i den første open-label fase) og med mindst 1 post baseline vurdering (for LOCF).
English: Functional decline was assessed by the investigator and cognitive decline was defined as a decrease in the MMSE score of >2 points from the previous visit or a decrease of >3 points from baseline.
Danish: Funktionel tilbagegang blev vurderet af investigator, og kognitiv tilbagegang blev defineret som et fald i MMSE score på >2 point fra det forrige besøg eller et fald på >3 point fra baseline.
English: In these cases, treatment should be discontinued (see section 4.3).
Danish: I disse tilfælde bør behandlingen afbrydes (se pkt.
English: It is recommended to apply the first transdermal patch on the day following the last oral dose.
Danish: Det anbefales at påføre det første depotplaster dagen efter den sidste orale dosis.
English: Oral and topical dosing in animal studies was limited due to the sensitivity of the animal models used.
Danish: Oral og topikal dosering i dyreforsøg var begrænset på grund af følsomheden af de anvendte dyremodeller.
English: 24-week placebo-controlled study
Danish: 24-ugers placebo-kontrolleret studie
English: Patients and caregivers should be instructed accordingly.
Danish: Patienter og omsorgsgivende personer skal instrueres i dette.
English: 48-week active comparator controlled study
Danish: 48-ugers aktiv komparator-kontrolleret studie
English: A direct comparison of the rate of skin irritation events reported in each of these studies cannot be made due to the difference in data collection methods employed.
Danish: En direkte sammenligning af frekvensen af hudirritationshændelser rapporteret i hvert af disse studier kan ikke foretages på grund af brug af forskellige dataindsamlingsmetoder.
English: Use of scopolamine as an antidote is not recommended.
Danish: Anvendelse af skolopamin som antidot kan ikke anbefales.
English: After the first dose, detectable plasma concentrations are observed after a lag time of 0.5-1 hour.
Danish: Efter den første dosis observeres der påviselige plasmakoncentrationer efter et interval på 0,5-1 time.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at bliver gravid, skal du spørge din læge eller apoteket til råds, før du bruger dette lægemiddel.
English: In some other dermal toxicity studies, a mild irritant effect on the skin of laboratory animals, including controls, was observed.
Danish: I nogle andre dermale toksicitetsundersøgelser blev der observeret en mildt irriterende effekt på laboratoriedyr, herunder kontroldyr.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
English: • Only one patch per day.
Danish: • Kun et plaster per dag.
English: ITT: Intent-To-Treat; LOCF: Last Observation Carried Forward 1 Based on ANCOVA with treatment and country as factors and baseline value as a covariate.
Danish: ITT: Intent-To-Treat; LOCF: Last Observation Carried Forward 1 Baseret på ANCOVA med behandling og land som faktorer og baselineværdi som co-variant.
English: Rivastigmine transdermal patches were not phototoxic.
Danish: Rivastigmin-depotplastrene var ikke fototoksiske.
English: Metabolism is primarily via cholinesterase-mediated hydrolysis to the metabolite NAP226-90.
Danish: Metaboliseringen sker primært via kolinesterasemedieret hydrolyse til metabolitten NAP226-90.
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppighed er angivet efter følgende regler: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The DLSM, 95% CI, and p-value are based on an ANCOVA (analysis of covariance) model adjusted for country and baseline ADAS-cog score.
Danish: DLSM, 95% CI, og p-værdi er baseret på ANCOVA (analysis of covariance) model tilpasset for lande og baseline ADAS-cog score.
English: - if you suffer from trembling.
Danish: - hvis du ryster meget.
English: You may have side effects more often when you start your medicine or when your dose is increased.
Danish: Du kan oftere få bivirkninger, når du starter med medicinen, eller går op til en højere dosis.
English: If you find you have forgotten to apply a patch, apply one immediately.
Danish: Hvis du har glemt at sætte et plaster på, skal du straks sætte et på.