FrancophonIA/ELRC3.0 huggingface dataset:
English: The studies assessed seem to indicate that metoclopramide reduces gastric transit time, but this did not translate into a clinically meaningful outcome (time taken to complete the examination).
Danish: De vurderede undersøgelser synes at vise, at metoclopramid reducerer den gastriske passagetid, men dette resulterede ikke i et klinisk meningsfyldt udfald (den tid, der medgår til at udføre undersøgelsen).
English: Metoclopramide has long been included in the British National Formulary for children (BNFc), which has been validated against emerging evidence, best practice guidelines and advice from a network of clinical experts.
Danish: Metoclopramid har længe været optaget i British National Formulary for children (BNFc), der er blevet valideret med ny evidens, retningslinjer for bedste praksis og rådgivning fra et net af kliniske eksperter.
English: The available evidence from small single dose studies suggests that metoclopramide clearance is substantially reduced in patients with hepatic cirrhosis.
Danish: Den foreliggende evidens fra små enkeltdosisundersøgelser tyder på, at clearance af metoclopramid er væsentligt nedsat hos patienter med levercirrose.
English: In its July 2013 opinion, the CHMP also recommended that oral liquid formulations be supplied with an appropriate measuring device such as a graduated oral syringe.
Danish: I sin udtalelse fra juli 2013 anbefalede CHMP desuden, at orale flydende formuleringer leveres med en egnet doseringsanordning såsom en oral sprøjte med målestreger.
English: The Committee also considered that the risk of unintentional overdose and associated adverse events in children can be lowered by limiting the maximum concentration of oral liquid formulations.
Danish: Udvalget tog desuden i betragtning, at risikoen for accidentel overdosering og tilknyttede bivirkninger hos børn kan mindskes ved begrænsning af den maksimale koncentration af orale flydende formuleringer,
English: On the basis of such limited and inconsistent data, it is not possible to conclude positively on the efficacy of metoclopramide in this indication.
Danish: Sådanne begrænsede og usammenhængende data giver ikke mulighed for en positiv konklusion om virkningen af metoclopramid ved denne indikation.
English: In its grounds for re-examination, the MAH also argued that in case of nausea drops are easier to swallow than tablets.
Danish: I sin begrundelse for fornyet overvejelse hævdede indehaveren af markedsføringstilladelsen desuden, at det ved kvalme er lettere at indtage dråber end tabletter.
English: The majority of cases of accidental overdose occurred in children and involve the use of high concentration oral liquid formulations.
Danish: De fleste tilfælde af accidentel overdosering fandt sted hos børn ved anvendelse af flydende orale formuleringer med høj koncentration.
English: It is noted that the majority of cases involves the use of high concentration oral liquid formulations, which are currently approved under a number of different formulations (oral drops, oral solution, syrup) with very different concentrations and a range of administration devices.
Danish: Det konstateres, at der i de fleste af tilfældene er anvendt flydende orale formuleringer med høj koncentration, der er godkendt som en række forskellige formuleringer (orale dråber, oral opløsning, syrup) med meget forskellig koncentration og en række forskellige administrationsanordninger.
English: In the absence of an established benefit, and taking into account the safety profile of metoclopramide, the Committee considered that the benefit-risk balance of metoclopramide in this indication is negative.
Danish: I fravær af en godtgjort gavnlig virkning og i betragtning af sikkerhedsprofilen af metoclopramid anså udvalget benefit/risk-forholdet for metoclopramid til denne indikation for at være negativt.
English: In order to minimise the risk of overdose in children, the MAH proposed to add the statement ‘for adults' in the label of oral liquid formulations with concentration > 1 mg/ml, and a contraindication in the paediatric population.
Danish: For at minimere risikoen for overdosering hos børn foreslog indehaveren af markedsføringstilladelsen at tilføje anvisningen “til voksne” på etiketten til orale flydende formuleringer med koncentration > 1 mg samt en kontraindikation hos den pædiatriske population.
English: In conclusion, the Committee considered that oral liquid formulations with concentration 1 mg/ml are suitable for all situations mentioned, and that the availability of higher concentrations carries a risk of overdose in the paediatric population that is unlikely to be resolved by the proposed changes to the product information.
Danish: Som konklusion fandt udvalget, at orale flydende formuleringer med koncentration 1 mg/mg er egnet til alle de nævnte situationer, og at rådighed over højere koncentrationer for den pædiatriske population medfører risiko for overdosering, som næppe kan forventes ophævet ved de foreslåede ændringer i produktinformationen.
English: Metoclopramide crosses the blood-brain barrier and is associated to extrapyramidal disorders and other serious neurological adverse events, which are of particular concern in children.
Danish: Metoclopramid krydser blod-hjernebarrieren og er forbundet med ekstrapyramidale forstyrrelser og andre alvorlige neurologiske bivirkninger, der navnlig er et problem hos børn.
English: • The Committee also noted that the data supporting the therapeutic indication ‘prevention of acute chemotherapy induced nausea and vomiting' is indicative of efficacy but requires the use of high doses.
Danish: • udvalget bemærkede desuden, at den terapeutiske indikation “forebyggelse af akut kemoterapiinduceret kvalme og opkastning” er underbygget med data, der viser virkning, men kræver brug af høje doser,
English: Each individual product is authorised for one or more of these indications, and in some cases the indication is specific to adults and/or children.
Danish: • Adjuvans til kirurgiske og radiologiske procedurer Hvert produkt er godkendt til en eller flere af disse indikationer, og i nogle tilfælde er indikationen begrænset til voksne og/eller børn.
English: Therefore it would be appropriate not to use metoclopramide during breastfeeding.
Danish: Det er derfor hensigtsmæssigt at undgå anvendelse af metoclopramid under amning.
English: Therefore, for these indications the Committee considered the benefitrisk balance to be positive.
Danish: For disse indikationer anså udvalget derfor benefit/risk-forholdet for at være positivt.
English: The Committee, as a consequence, concluded that the benefit-risk balance of metoclopramidecontaining medicinal products remains positive, taking into account the changes to the product information and risk minimisation measures recommended.
Danish: Udvalget konkluderede som følge heraf, at benefit/risk-forholdet for lægemidler indeholdende metoclopramid fortsat er positivt under forudsætning af de anbefalede ændringer af produktinformationen og risikominimeringsforanstaltninger.
English: However, a few cases of extrapyramidal reactions in newborns exposed to metoclopramide before delivery have been identified.
Danish: Der er imidlertid konstateret enkelte tilfælde af ekstrapyramidale reaktioner hos nyfødte, som blev eksponeret for metoclopramid før fødslen.
English: According to the BNFc, in patients at low risk of emesis, pre-treatment with metoclopramide continued for up to 24 hours after chemotherapy is often effective.
Danish: For patienter med lav risiko for emese er det ifølge BNFc ofte effektivt at fortsætte forbehandlingen med metoclopramid i op til 24 timer efter kemoterapi.
English: The Committee noted this proposal from the MAH, but it also took note of the fact that, even if not specifically approved for paediatric use, high concentration oral liquid formulations are associated with risks in this population.
Danish: Udvalget tog forslaget fra indehaveren af markedsføringstilladelsen til efterretning, men hæftede sig ved, at skønt orale flydende formuleringer med høj koncentration ikke er specielt godkendt til pædiatrisk anvendelse, er de forbundet med risici for denne population.
English: The MAH considered in its grounds that for oral liquid solutions a concentration of 4 mg/ml is too high for children and that there is a risk of overdose in this population.
Danish: Indehaveren af markedsføringstilladelsen fandt i sin begrundelse, at for orale opløsninger er en koncentration på 4 mg/ml for høj for børn, og at der er risiko for overdosering hos denne population.
English: The CHMP considered that formulations with concentration 1mg/ml are suitable for those patients that may prefer an oral liquid formulation to a solid pharmaceutical form.
Danish: CHMP fandt, at formuleringer med koncentrationen 1 mg/ml er egnede til de patienter, der foretrækker en oral flydende formulering frem for en fast lægemiddelform.
English: No data was submitted by the MAH in support of the above claims.
Danish: Indehaveren af markedsføringstilladelsen fremlagde ikke data til støtte for ovenstående påstande.
English: Gastroparesis is often a chronic disorder, for which long term treatment is necessary, therefore existing data cannot be considered supportive of the use in this indication.
Danish: Gastroparese er i mange tilfælde en kronisk sygdom, der kræver langvarig behandling, hvorfor de eksisterende data ikke findes at underbygge anvendelsen til denne indikation.
English: For this indication, prophylaxis is usually initiated with a 5-HT3 receptor antagonist before chemotherapy and is followed by metoclopramide (usually oral) prescribed for a further 24-48 hours.
Danish: Til denne indikation indledes forebyggende behandling før kemoterapi sædvanligvis med en 5-HT3-receptorantagonist, efterfulgt af metoclopramid (sædvanligvis oralt) i yderligere 2448 timer.
English: Very limited data exists in support of the efficacy of metoclopramide in this indication, and the existing data is not consistent.
Danish: Der findes kun meget begrænsede data til støtte for virkningen af metoclopramid til denne indikation, og de eksisterende data er ikke samstemmende.
English: For the majority of the indications, there is clinical data evaluating the efficacy of the posology of 10 mg three times a day.
Danish: For størstedelen af indikationerne foreligger der kliniske data til vurdering af doseringen 10 mg tre gange dagligt.
English: While metoclopramide was found to improve gastric emptying and relieve symptoms in diabetic and idiopathic gastroparesis in short term treatment when compared to placebo, no consistent benefit was observed in the long term.
Danish: Metoclopramid fandtes at forbedre ventrikeltømningen og lindre symptomerne ved korttidsbehandling af diabetisk og idiopatisk gastroparese mere end placebo, men på langt sigt sås ikke vedholdende gavnlig virkning.
English: The data presented in support of the effect of metoclopramide in post-operative nausea and vomiting indicates that it has similar efficacy to other active substances authorised in this indication.
Danish: De forelagte data om virkningen af metoclopramid ved postoperativ kvalme og opkastning viser sammenlignelig virkning med andre aktive stoffer, der er godkendt til denne indikation.
English: Therefore the Committee considered that it is an important risk minimisation measure to restrict the maximum concentration of oral liquid formulations to 1 mg/ml, to ensure that clear instructions are given in the product information on posology for paediatric patients and that these oral liquid formulations are supplied with an appropriate measuring device such as a graduated oral syringe.
Danish: Udvalget fandt derfor, at det er en vigtig risikominimeringsforanstaltning at begrænse den maksimale koncentration af flydende orale formuleringer til 1 mg/ml, at sørge for klare anvisninger i produktinformationen om doseringen til pædiatriske patienter og for, at sådanne flydende orale formuleringer leveres med en velegnet doseringsanordning såsom en oral sprøjte med målestreger.
English: Both the 50% and the 75% dose reductions recommended, respectively, in hepatic and renal impairment are easily achievable with the 1 mg/ml liquid formulations.
Danish: De anbefalede dosisreduktioner på 50 % og 75 % ved henholdsvis nedsat leverfunktion og nedsat nyrefunktion kan begge let opnås med flydende formuleringer i styrken 1 mg/ml.
English: The available evidence in relation to CYP2D6 polymorphisms, when taken together with the data on interactions with CYP2D6 inhibitors, is suggestive that whilst CYP2D6 metabolism is not the main metabolic pathway for metoclopramide, the inhibition of this pathway due to polymorphisms or pharmacokinetic interactions with other drugs may potentially be clinically significant.
Danish: Den foreliggende evidens vedrørende CYP2D6-polymorfier tyder sammen med data om interaktioner med CYP2D6-hæmmere på, at hæmning af denne metaboliseringsvej som følge af polymorfier eller farmakokinetisk interaktion med andre lægemidler kan have potentiel klinisk betydning, selv om CYP2D6-metabolisering ikke er den vigtigste metaboliseringsvej for metoclopramid.
English: • In view of the available data the Committee also concluded that the benefit-risk balance of metoclopramide-containing products:
Danish: • I betragtning af de foreliggende data konkluderede udvalget desuden, at benefit/riskforholdet for produkter indeholdende metoclopramid:
English: o Is favourable in adults for ‘symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting' (parenteral route) and ‘symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting.
Danish: o positivt hos voksne til “symptomatisk behandling af kvalme og opkastning ved migræne” (parenteral administration) og “symptomatisk behandling af kvalme og opkastning ved migræne, herunder kvalme og opkastning ved akut migræne.
English: For therapeutic indications such as delayed CINV, prevention of RINV, prevention of PONV and symptomatic treatment of nausea and vomiting including migraine induced nausea and vomiting, data is indicative of efficacy at low doses (10mg, three times daily) which minimise the risk of serious neurological adverse reactions.
Danish: Til terapeutiske indikationer såsom forsinket kemoterapiinduceret kvalme og opkastning, forebyggelse af stråleterapiinduceret kvalme og opkastning, forebyggelse af postoperativ kvalme og opkastning samt symptomatisk behandling af kvalme og opkastning, herunder kvalme og opkastning ved migræne, viser dataene virkning ved lave doser (10 mg tre gang dagligt), hvilket minimerer risikoen for alvorlige neurologiske bivirkninger.
English: Given the limited therapeutic alternatives for the paediatric population in this setting, it may be acceptable that delayed CINV is retained as a second line option despite the lack of robust efficacy data.
Danish: På baggrund af de begrænsede behandlingsalternativer for den pædiatriske population i dette scenarie kan det være acceptabelt at bibeholde indikationen forsinket kemoterapiinduceret kvalme og opkastning som andetvalgsbehandling trods de manglende pålidelige data om virkning.
English: For the indication acute CINV, while there is some data indicative of efficacy, it requires the intravenous use of high doses of metoclopramide which carry higher risks not only of neurological but also cardiovascular adverse reactions (including cardiac arrest).
Danish: For indikationen akut kemoterapiinduceret kvalme og opkastning foreligger der en del data, der viser virkning, man der kræves høje intravenøse doser af metoclopramid, som indebærer højere risici ikke kun for neurologiske, men også kardiovaskulære bivirkninger (herunder hjertestop).
English: With regards to the delayed CINV, the Committee agreed with the previous assessment that the data is limited and shows that metoclopramide is inferior to 5-HT3 receptor antagonists.
Danish: Vedrørende forsinket kemoterapiinduceret kvalme og opkastning tilsluttede udvalget sig den tidligere vurdering: De begrænsede data viser, at metoclopramid er inferiørt i forhold til 5-HT3receptorantagonister.
English: When administered for moderately emetic chemotherapy, doses ranging from 30 to 60mg appear to be effective.
Danish: Når det anvendes ved moderat emetisk kemoterapi synes det at være effektivt i doser fra 30 til 60 mg.
English: This body of data is more consistent and indicates similar efficacy for these doses of metoclopramide given orally to the efficacy of 5-HT3 receptor antagonists.
Danish: Disse data er mere overensstemmende og viser, at metoclopramid i disse orale doser har en virkning svarende til 5-HT3receptorantagonisters.
English: The MAH considered that oral liquid formulations with concentration higher than 1 mg/ml continue to be useful for adult patients, in terms of dosing (less number of drops are necessary to achieve the intended dose with a higher concentration solution) and in terms of easiness of administration vis-à-vis tablets.
Danish: Indehaveren af markedsføringstilladelsen fandt, at orale flydende formuleringer med koncentration over 1 mg/ml fortsat er nyttige til voksne patienter hvad angår doseringen (med en mere koncentreret opløsning kræves færre dråber for at opnå den tilsigtede dosis) og hvad angår bekvem administration sammenlignet med tabletter.
English: Post marketing data is suggestive of unintended misuse of these formulations (oral drops, oral solution, syrup), approved under a range of concentrations and with a range of administration devices potentially leading to the inadvertent administration of doses higher than intended.
Danish: Data efter markedsføring tyder på utilsigtet fejlanvendelse af disse formuleringer (orale dråber, oral opløsning, sirup), som er godkendt i en række høje koncentrationer og med en række doseringsanordninger, der potentielt kan medføre administration af utilsigtet høje doser.
English: The MAH disagreed with the CHMP recommendation for revocation of oral liquid formulations with concentration higher than 1 mg/ml.
Danish: Indehaveren af markedsføringstilladelsen tilsluttede sig ikke CHMP's anbefalinger om tilbagekaldelse af orale væskeformige formuleringer med en koncentration over 1 mg/ml.
English: Based on data from both the Jantunen meta-analysis and the randomised clinical studies assessed, metoclopramide administered intravenously or orally is consistently inferior to 5-HT3 receptor antagonists for prevention of acute CINV for highly or moderately emetogenic chemotherapy.
Danish: Både Jantunen-metaanalysen og de vurderede randomiserede kliniske undersøgelser viser, at hvad enten metoclopramid administreres intravenøst eller oralt, er det vedholdende inferiørt i forhold til 5-HT3-receptorantagonister til forebyggelse af akut kemoterapiinduceret kvalme og opkastning ved stærkt eller moderat emetogen kemoterapi.
English: While considering that the concentration 4 mg/ml is appropriate for adults, the MAH recognised that it is too high for children and therefore proposed the measures to avoid the risk of overdose in children, including contraindication in this patient population.
Danish: Indehaveren af markedsføringstilladelsen fandt koncentrationen 4 mg/ml velegnet til voksne, men vedgik, at den er for høj til børn, og foreslog derfor foranstaltninger til undgåelse af overdosering af børn, herunder en kontraindikation hos denne patientpopulation.
English: • Gastrointestinal motility disorders including gastroparesis
Danish: • Gastrointestinale motilitetsforstyrrelser, herunder gastroparese
English: There is sufficient evidence of efficacy of metoclopramide in the treatment of post-operative nausea and vomiting in the paediatric population.
Danish: Der er tilstrækkelig evidens for virkningen af metoclopramid til behandling af postoperativ kvalme og opkastning hos den pædiatriske population.
English: For this reason, the Committee considered that the benefit-risk balance of metoclopramide in this indication is negative and recommended that it is deleted.
Danish: Udvalget fandt derfor, benefit/risk-forholdet for denne indikation er negativt, og anbefalede, at den slettes.
English: The lack of placebo-controlled trial data prevents assessment of the absolute efficacy of metoclopramide in these indications.
Danish: I mangel af placebokontrollerede undersøgelser er det ikke muligt at vurdere den absolutte virkning af metoclopramid til disse indikationer.
English: Limited data exists on the efficacy of metoclopramide in the different therapeutic indications authorised in the European Union; however, when taken together, it is indicative of the efficacy of the product in the management of nausea and vomiting of different origins.
Danish: Der foreligger kun begrænsede data om virkningen af metoclopramid ved de forskellige terapeutiske indikationer, der er godkendt i EU, men tilsammen viser dataene, at produktet er effektivt til behandling af kvalme og opkastning af forskellige årsager.
English: Metoclopramide has long been associated with a risk of serious neurological adverse reactions such as acute extrapyramidal symptoms and irreversible tardive dyskinesia.
Danish: Metoclopramid er længe blevet sat i forbindelse med risiko for alvorlige neurologiske bivirkninger såsom akutte ekstrapyramidale symptomer og irreversibel tardiv dyskinesi.
English: Data on the dosing seems to indicate that individual doses of metoclopramide higher than 10mg do not result in increased efficacy.
Danish: Data om doseringen synes at vise, at virkningen ikke øges ved enkeltdoser af metoclopramid ud over 10 mg.
English: As such, based on the data assessed, the relative efficacy must be assessed in comparison to the 5-HT3 receptor antagonists.
Danish: Den relative virkning må som sådan vurderes ved sammenholdelse med 5-HT3-receptorantagonisterne.
English: The data presented in relation to the prevention of delayed CINV is predominantly in patients receiving moderately emetogenic chemotherapy, using oral metoclopramide at doses of 10-20 mg three or four times a day.
Danish: De forelagte data vedrørende forebyggelse af forsinket kemoterapiinduceret kvalme og opkastning omfatter hovedsagelig patienter, der fik moderat emetogen kemoterapi og orale doser af metoclopramid på 10-20 mg tre eller fire gange dagligt.
English: Considering the newly recommended posology, parenteral formulations with concentration higher than 5mg/ml currently approved in the European Union (mainly for the management of acute CINV) will not be suitable for administration of the 10mg dose, are therefore considered to have a negative benefitrisk balance and should be revoked.
Danish: De parenterale formuleringer med større koncentration end 5 mg/ml, der på nuværende tidspunkt er godkendt i EU (hovedsagelig til behandling af akut kemoterapiinduceret kvalme og opkastning), er ikke egnede til administration af en dosis på 10 mg. I betragtning af den nye doseringsanbefaling anses de derfor for at have et negativt benefit/risk-forhold og bør afregistreres.
English: While in some cases higher doses may be currently authorised, with the exception of acute CINV the existing data does not clearly indicate that higher doses result in increased efficacy.
Danish: Skønt der i nogle tilfælde er godkendt højere doser, fremgår det ikke klart af de eksisterende data,
English: It is possible that there is unintended misuse of the high concentration oral liquid formulations, leading to the inadvertent administration of doses higher than intended.
Danish: De orale flydende formuleringer med høj koncentration giver mulighed for utilsigtet fejlanvendelse ved administration af højere doser end den tilsigtede.
English: Based on the data presented, there is little evidence of efficacy of metoclopramide in treatment of gastroesophageal reflux disease or dyspepsia and existing data is not consistent in terms of effect.
Danish: De forelagte data giver kun ringe evidens for virkningen af metoclopramid til behandling af gastroøsofageal reflukssygdom eller dyspepsi og er ikke samstemmende hvad angår virkningen.