FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the EU for Quadrisol on 4 December 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Quadrisol den 4. december 1997.
English: The withdrawal period for meat from horses treated with Quadrisol is 12 days.
Danish: Tilbageholdelsestiden for kød fra heste, der behandles med Quadrisol, er 12 dage.
English: The full EPAR for Quadrisol can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Quadrisol findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: When used before an operation it is given at least 3 hours before the operation and treatment may be continued for up to one week.
Danish: Når det anvendes inden operation, gives det op til 3 timer før operationen, og behandlingen kan fortsættes i op til en uge.
English: It contains the active substance vedaprofen.
Danish: Det indeholder det aktive stof vedaprofen.
English: This is a summary of the European public assessment report (EPAR) for Quadrisol.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Quadrisol.
English: Quadrisol, available as an oral (mouth) gel, is given twice daily before feeding for a maximum of two weeks.
Danish: Quadrisol, der fås som oral gel, gives to gange dagligt inden fodring i højst to uger.
English: Side effects are generally reversible once the medicine is stopped.
Danish: Bivirkningerne er generelt reversible, når behandlingen afbrydes.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Quadrisol's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Quadrisol opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Quadrisol can also be used to relieve pain and reduce inflammation after an operation.
Danish: Quadrisol kan også anvendes til at lindre smerter og mindske inflammation efter en operation.
English: Vedaprofen blocks an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Danish: Vedaprofen blokerer enzymet cyclooxygenase, der medvirker ved produktionen af prostaglandiner.
English: It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use.
Danish: Det forklarer, hvordan agenturet vurderede dette lægemiddel til dyr for at kunne anbefale udstedelse af en markedsføringstilladelse i EU og fastlægge anvendelsesbetingelserne.
English: It must not be given to foals aged less than six months or to mares producing milk.
Danish: Det må ikke gives til føl på under seks måneder eller til hopper, der producerer mælk.
English: It is not intended to provide practical advice on how to use Quadrisol.
Danish: Det er ikke en praktisk vejledning i, hvordan Quadrisol bør anvendes.
English: The medicine is not authorised for use in horses producing milk for human consumption.
Danish: Lægemidlet må ikke anvendes til heste, der producerer mælk til menneskeligt konsum.
English: It is also the time required after administration of a medicine before milk may be used for human consumption.
Danish: Det er også den tid, der skal gå efter administration af et lægemiddel, før mælken kan anvendes til menneskeligt konsum.
English: Why is Quadrisol approved?
Danish: Hvorfor blev Quadrisol godkendt?
English: What is Quadrisol and what is it used for?
Danish: Hvad er Quadrisol, og hvad anvendes det til?
English: Quadrisol contains vedaprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Quadrisol indeholder vedaprofen, som tilhører en lægemiddelgruppe, der kaldes ikkesteroide antiinflammatoriske lægemidler (NSAID'er).
English: As prostaglandins are substances that trigger inflammation, pain, and fever, vedaprofen reduces these signs of injury.
Danish: Prostaglandiner er stoffer, som udløser inflammation, smerter og feber, og vedaprofen mindsker disse tegn på skader.
English: Other information about Quadrisol:
Danish: Andre oplysninger om Quadrisol
English: For the full list of restrictions, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: What are the risks associated with Quadrisol?
Danish: Hvilke risici er der forbundet med Quadrisol ?
English: Quadrisol oral gel improved lameness and soft tissue injuries in horses and the response to treatment with Quadrisol was similar to the response to either flunixine meglumine or phenylbutazone, which are other NSAIDs used to treat these conditions.
Danish: Quadrisol oral gel forbedrede halten og bløddelslæsioner hos heste, og responsen på behandlingen med Quadrisol var den samme som for både flunixin meglumin og phenylbutazon (andre NSAID'er, der anvendes til disse lidelser).
English: The side effects of Quadrisol are typical for those seen with other medicines from this product class (NSAIDs) such as lethargy or damage to (lesions) the mouth, stomach, intestines (including soft stools or diarrhoea) and kidneys.
Danish: Bivirkningerne ved Quadrisol er typiske for lægemidler i denne klasse af lægemidler (NSAID'er), f.eks. sløvhed eller skader (læsioner) i mund, mave, tarme (herunder blød afføring og diarré) og nyrer.
English: Quadrisol must not be given to horses with stomach and gut disorders or to horses with reduced heart, liver and kidney function.
Danish: Quadrisol må ikke gives til heste med mave- og tarmforstyrrelser eller til heste med nedsat hjerte-, lever- eller nyrefunktion.
English: In horses, skin rashes (urticaria) have been reported.
Danish: For heste er der indberettet om nældefeber.
English: What benefits of Quadrisol have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Quadrisol?
English: How is Quadrisol used?
Danish: Hvordan anvendes Quadrisol?
English: For more information about treatment with Quadrisol, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Quadrisol, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How does Quadrisol work?
Danish: Hvordan virker Quadrisol?
English: For practical information about using Quadrisol, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Quadrisol, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Quadrisol is a veterinary medicine used in horses to relieve pain and reduce inflammation due to injury to the muscle, bones and joints as well as to other non-bony areas of the body (so called soft tissue lesions).
Danish: Quadrisol er et veterinærlægemiddel, der anvendes til heste til at lindre smerte og mindske inflammation ved skader på muskler, knogler og led foruden ved andre bløddelslæsioner.
English: This included studies in a large number of horses with bone, muscle and other soft tissue and joint problems.
Danish: Quadrisol er undersøgt både i laboratorieundersøgelser og feltundersøgelser, herunder undersøgelser hos et stort antal heste med lidelser i knogler og muskler og andre bløddele og med ledproblemer.
English: The medicine can only be obtained with a prescription For further information, see the package leaflet.
Danish: Lægemidlet udleveres kun efter recept.
English: Annex II
Danish: Bilag II
English: However new cases of cardiotoxicity continued to be reported.
Danish: Der blev imidlertid fortsat indberettet nye tilfælde af kardiotoksicitet.
English: However it is important that this be confirmed in an appropriate pharmacokinetic study.
Danish: Det er imidlertid vigtigt, at dette bekræftes ved en fyldestgørende farmakokinetisk undersøgelse.
English: As a consequence, the intravenous formulation was withdrawn worldwide.
Danish: Som følge heraf blev den intravenøse formulering trukket tilbage verden over.
English: • Nausea and vomiting of functional, organic, infectious or dietetic origin
Danish: • kvalme og opkastning af funktionel, organisk, infektiøs eller ernæringsmæssig oprindelse
English: • The revocation of the marketing authorisations for:
Danish: • inddragelse af markedsføringstilladelserne for:
English: The CMDh agreed to:
Danish: CMD(h) tilsluttede sig:
English: However, it is not expected that the mechanism of action will differ between adults and children, and there is in some Member States long-lasting clinical experience with this product in children.
Danish: Virkningsmekanismen hos børn forventes dog ikke at være anderledes end hos voksne, og nogle medlemsstater har lang klinisk erfaring med lægemidlet hos børn.
English: • Nausea and vomiting induced by:
Danish: • kvalme og opkastning forårsaget af:
English: these circumstances patients should not be exposed to the additional risk associated to a combination product.
Danish: disse forudsætninger bør patienterne ikke udsættes for den ekstra risiko, der knyttet til et kombinationslægemiddel.
English: Overall summary of the scientific evaluation by PRAC
Danish: Samlet resumé af PRAC's videnskabelige vurdering
English: 1 - PRAC recommendation
Danish: 1 - PRAC's anbefaling
English: • dopamine agonists (such as L-dopa and bromocriptine) used in the treatment of Parkinson's disease
Danish: • dopaminagonister (såsom L-dopa og bromocriptin), der anvendes til behandling af Parkinsons sygdom
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for domperidonecontaining medicinal products.
Danish: • PRAC fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for lægemidler indeholdende domperidon,
English: Minor amendments were also introduced in the Product Information for clarity.
Danish: Endvidere blev der af klarhedshensyn indført mindre rettelser i produktinformationen.
English: However, the CMDh considered that changes were necessary to proposed conditions to the Marketing Authorisations (Annex IV).
Danish: CMD(h) fandt dog, at der var behov for ændringer i de foreslåede betingelser for markedsføringstilladelserne (bilag IV).
English: Domperidone is commonly used across Europe since 1970s when it was first time authorized via national procedures.
Danish: Domperidon har haft udbredt anvendelse i Europa siden 1970'erne, hvor det første gang blev godkendt via nationale procedurer.
English: In October 2011 the PhVWP agreed on amendments to the product information, and the Marketing Authorisation Holder of the originator product was requested to conduct a pharmacoepidemiological study and a thorough QTc study.
Danish: I oktober 2011 vedtog PhVWP ændringer af produktinformationen, og indehaveren af markedsføringstilladelsen for det oprindelige lægemiddel blev anmodet om at udføre en farmakoepidemiologisk undersøgelse og en gennemgribende QTcundersøgelse.
English: • The CMDh considered that the drug utilisation study in condition 3 needs to be performed in more than one Member State in order to achieve its goal of monitoring off-label use.
Danish: • CMD(h) fandt, at undersøgelsen af lægemiddelanvendelse i betingelse 3 bør udføres i mere end én medlemsstat for at opfylde formålet om overvågning af ikke-godkendt anvendelse.
English: 2 - Detailed explanation for the differences from the PRAC recommendation
Danish: 2 - Detaljeret begrundelse for afvigelserne fra PRAC's anbefaling
English: Whenever available, paediatric patients should make use of other formulations that allow for more accurate dosing (e.g. oral solution) and these should be supplied with an appropriate measuring device.
Danish: Om muligt bør der til pædiatriske patienter anvendes andre formuleringer, der giver mulighed for mere nøjagtig dosering (f.eks. oral opløsning), og de bør leveres med en egnet doseringsanordning.
English: • radiotherapy or drug therapy
Danish: • stråleterapi eller medikamentel behandling
English: In view of the cardiac risk, off-label use should be monitored.
Danish: På baggrund af den kardiale risiko bør ikke godkendt anvendelse overvåges.
English: Domperidone is a peripheral dopamine D2-receptor antagonist with gastrokinetic and anti-emetic properties.
Danish: Domperidon er en perifer dopamin D2-receptorantagonist med gastrokinetiske og antiemetiske egenskaber.
English: The International Birth Date for domperidone has been designated as March 1978, based on the first approval of domperidone in Belgium.
Danish: Den internationale fremkomst af domperidon regnes for at have fundet sted i marts 1978, hvor den første godkendelse af domperidon blev udstedt i Belgien.
English: Domperidone is marketed in several formulations, for oral or rectal administration under various trade names.
Danish: Domperidon markedsføres i eller række formuleringer til oral eller rektal indgift under forskellige handelsnavne.
English: A formulation for intravenous (IV) administration was discontinued in 1985.
Danish: En intravenøs formulering blev trukket tilbage i 1985.
English: In this respect, the PRAC further noted that not only the efficacy data is limited but it does not actually demonstrate the superiority of the combination over the single component product.
Danish: I denne forbindelse bemærkede PRAC yderligere, at dataene vedrørende virkning ikke kun er begrænsede, men faktisk ikke dokumenterer kombinationspræparatets overlegenhed over enkeltkomponentpræparatet.
English: • Extend the timeframe for the submission of the final study report on condition 1 (generation of paediatric efficacy data).
Danish: • forlængelse af fristen for indsendelse af slutrapporten for undersøgelsen vedrørende betingelse 1 (generering af pædiatriske data vedrørende virkning).
English: In addition, the CMDh took the opportunity to introduce the following clarification to the description of the products for which revocation is recommended:
Danish: Derudover benyttede CMD(h) lejligheden til at indføre følgende præcisering i beskrivelsen af de lægemidler, der anbefales trukket tilbage:
English: CMDh position
Danish: CMD(h)'s standpunkt
English: For the reasons mentioned above, it is critical that patients are given the lowest possible effective dose and the PRAC considered that a recommendation for 0.25 mg/kg up to 3 times a day was appropriate.
Danish: Af ovennævnte grunde er det afgørende, at patienterne får den laveste effektive dosis, og PRAC fandt det passende at anbefale 0,25 mg/kg op til tre gange dagligt.
English: As a consequence of the new maximum recommended doses, the PRAC considered that certain formulations such as tablets dosed at 20 mg and suppositories dosed at 60 mg have a negative benefit-risk balance and should therefore be revoked.
Danish: Som følge af de nye anbefalede maksimale doser fandt PRAC, at visse formuleringer såsom tabletter på 20 mg og suppositorier på 60 mg har negativt benefit/risk-forhold og bør trækkes tilbage.
English: It is therefore important that the risk is minimised by restricting the maximum dose (10 mg up to 3 times a day for adults and adolescents 12 years of age and older and weighing ≥ 35 kg), limiting treatment duration to the shortest necessary to control symptoms and contraindicating other drugs that are also known to prolong the QT-interval.
Danish: Det er derfor vigtigt at minimere risikoen ved at begrænse den maksimale dosis (10 mg op til tre gange dagligt til voksne og unge over 12 år med legemsvægt ≥ 35 kg), behandle i den kortest mulige tid, der er nødvendig til kontrol af symptomerne, og kontraindicere andre lægemidler, som også forlænger QT-intervallet.
English: − combination products containing domperidone/cinnarizine
Danish: − kombinationslægemidler indeholdende domperidon/cinnarizin
English: When considering existing data in support of the efficacy of domperidone, the PRAC concluded that overall there is sufficient evidence1,2,3 in support of the use in a general indication in the relief of symptoms of nausea and vomiting in adults.
Danish: Ved vurdering af de eksisterende data til dokumentation af virkningen af domperidon konkluderede PRAC, at der overordnet er tilstrækkelig evidens1,2,3 for anvendelsen til den generelle indikation lindring af symptomerne ved kvalme og opkastning hos voksne.
English: However, in order to ensure that the study will provide relevant data, MAHs are requested to submit the protocols for agreement to the National Competent Authorities.
Danish: For at sikre, at undersøgelsen giver relevante data, anmodes indehaverne af markedsføringstilladelse dog om at indsende protokoller til godkendelse hos de nationale kompetente myndigheder.
English: Therefore the PRAC concluded that the benefit-risk balance of rectal formulations for paediatric patients is negative due to the potential for overdose.
Danish: PRAC konkluderede derfor, at benefit/risk-forholdet for rektale formuleringer til pædiatriske patienter er negativt på grund af potentialet for overdosering.
English: The CMDh highly recommends that MAHs collaborate in order to avoid unnecessary duplication of studies.
Danish: CMD(h) anbefaler stærkt, at indehaverne af markedsføringstilladelse samarbejder for at undgå unødig overlapning mellem undersøgelserne,
English: The extrapolation of existing pharmacokinetic data allows for a conclusion that the 30 mg suppository administered twice a day should be equivalent to the 10 mg oral formulation administered 3 times a day.
Danish: Ved ekstrapolation af eksisterende farmakokinetiske data kan det konkluderes, at et 30 mg suppositorium to gange dagligt kan forventes at være ækvivalent med 10 mg oralt tre gange dagligt.
English: Therefore some of the high dose formulations can no longer be recommended.
Danish: Det må derfor frarådes at anvende visse af højdosisformuleringerne,
English: • The PRAC considered that the risk of serious cardiac adverse drug reactions can be minimised by using lower doses of domperidone, limiting treatment duration and contraindicating treatment for patients at particularly high risk (patients with moderate or severe hepatic impairment, patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure) and patients concurrently taking QT-prolonging drugs or potent CYP3A4 inhibitors.
Danish: • PRAC anså risikoen for alvorlige kardiale lægemiddelreaktioner for at kunne minimeres ved at anvende lavere doser af domperidon, begrænse behandlingens varighed og kontraindicere behandlingen hos patienter med særligt høj risiko (patienter med moderat eller svær leverfunktionsnedsættelse, patienter med kendt forlængelse af kardiale ledningsintervaller, navnlig QTc, patienter med betydningsfuld elektrolytforstyrrelse eller underliggende kardial sygdom såsom venstresidig hjerteinsufficiens) og patienter i behandling med QT-forlængende lægemidler eller potente CYP3A4-hæmmere.
English: o epigastric sense of fullness, early satiety, feeling of abdominal distension, upper abdominal pain o bloating, eructation, flatulence o nausea and vomiting o heartburn with or without regurgitations of gastric contents in the mouth
Danish: o fornemmelse af epigastrisk fyldthed, tidlig mæthed, fornemmelse af abdominal oppression, øvre abdominalsmerter o oppustethed, eruktation, flatulens o kvalme og opkastning o halsbrand med eller uden tilbagestrømning af maveindhold i munden
English: It exerts its action via inhibition of dopamine receptors in the human gut, and in the chemoreceptor trigger zone, which lies outside the blood-brain barrier in the area postrema.
Danish: Det virker ved at hæmme dopaminreceptorer i den humane tarm og i aktiveringszonen for kemoreceptorer, der ligger i area postrema uden for blod-hjernebarrieren.
English: • The variation to the terms of the marketing authorisation for the remaining domperidonecontaining medicinal products referred to in Annex I, for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation.
Danish: • ændring af markedsføringstilladelsen for de orale formuleringer af de øvrige domperidonholdige lægemidler, der er omhandlet i bilag 1, for hvilke de relevante afsnit af produktresuméet, og indlægssedlen fremgår af bilag III til PRAC's 's udtalelse.
English: Grounds for the revocation / variation to the terms of the marketing authorisation
Danish: Begrundelse for inddragelse/ændring af betingelserne for markedsføringstilladelsen
English: The available clinical and non-clinical data consistently indicates that there is an increased risk of serious and potentially life-threatening cardiac adverse drug reactions associated with domperidone use.
Danish: De foreliggende kliniske og ikke-kliniske data viser samstemmende øget risiko for alvorlige og potentielt livstruende kardiale bivirkninger med domperidon.
English: − oral formulations at a strength higher than 10 mg
Danish: − orale formuleringer med styrke over 10 mg
English: In light of the above, on 01 March 2013 Belgium informed the European Medicines Agency, pursuant to Article 31 of Directive 2001/83/EC, of their decision to trigger an Art. 31 referral procedure to ask for the PRAC's recommendation on whether the balance of benefits and risks for these products is still positive in the approved indications, and whether the marketing authorisations for medicinal products containing domperidone should be maintained, varied, suspended or withdrawn.
Danish: På denne baggrund foretog Belgien den 1. marts 2013 i medfør af artikel 31 i direktiv 2001/83/EF en indbringelse for det europæiske Lægemiddelagentur med anmodning om, at PRAC fremsatte en anbefaling om, hvorvidt benefit/risk-forholdet for disse lægemidler fortsat er positivt til de godkendte indikationer, og hvorvidt markedsføringstilladelserne for lægemidler indeholdende domperidon bør opretholdes, ændres, suspenderes eller inddrages.
English: A possible association between domperidone and QT-prolongation and cardiac adverse events was identified in the mid-1980s, when high and rapidly administered intravenous doses were used as an anti-emetic during cytotoxic treatment in cancer patients.
Danish: I midten af 1980'erne blev der konstateret en mulig sammenhæng mellem domperidon og QTforlængelse og kardiale bivirkninger, når der blev anvendt store, hurtigt indgivne intravenøse doser af domperidon som antiemetikum under cytotoksisk behandling af kræftpatienter.
English: In addition, in order to ensure that National Competent Authorities are informed of the study progress, MAHs are required to submit yearly updates on progress with recruitment to the study.
Danish: For at sikre, at de nationale kompetente myndigheder holdes orienteret om forløbet af undersøgelsen, anmodes indehaverne af markedsføringstilladelse endvidere om at indsende årlige statusrapporter om forløbet af rekrutteringen til undersøgelsen.
English: The authorized indications of domperidone, as listed in the Company Core Data Sheet of the originator, are presented below:
Danish: Der er følgende godkendte indikationer for domperidon i henhold til virksomhedens centrale datablad for det oprindelige lægemiddel:
English: In addition, the data supporting the efficacy of the combination domperidone/cinnarizine for motion sickness are limited, do not demonstrate the superiority of the combination over the single component product and therefore do not justify exposing patients to the additional risk associated to a combination product.
Danish: Desuden er data til støtte for virkningen af kombinationen domperidon/cinnarizin mod transportsyge begrænsede og viser ikke overlegenhed af kombinationen i forhold til enkeltkomponentlægemidlet, hvorfor det ikke er berettiget at udsætte patienterne for den ekstra risiko, der er forbundet med et kombinationslægemiddel,