FrancophonIA/ELRC3.0 huggingface dataset:
English: It is clearly stated in the Opinion that 50% of the formulations were found to be affected by alcohol in vitro.
Danish: Det nævnes tydeligt i udtalelsen, at 50 % af formuleringerne viste sig at blive påvirket af alkohol in vitro.
English: • The Committee considered all the available data submitted by the MAHs,
Danish: • Udvalget behandlede alle de tilgængelige data fra indehaverne af markedsføringstilladelserne,
English: While most products already contain warnings and references to this interaction in the SPC, the wording should be harmonised to ensure the same level of awareness.
Danish: Advarsler og henvisninger til denne interaktion fremgår allerede af produktresuméet for størstedelen af lægemidlerne, men ordlyden bør harmoniseres for at sikre, at der skabes det samme bevidsthedsniveau.
English: The results of the only study with a morphine product (ethylcellulose N-50, methacrylic acid copolymer type C, polyethylene glycol 6000 and diethyl phthalate formulation) indicate that a relatively high quantity of alcohol has almost no effect in vivo.
Danish: Resultaterne af den eneste undersøgelse af et morfinlægemiddel (formulering af ethylcellulose N-50, methacrylsyre copolymer type C, polyethylenglycol 6000 og diethylphthalat) indikerer, at en forholdsvis stor mængde alkohol næsten ingen effekt havde in vivo.
English: Secondly, because unlike alcohol, SPC information on food interactions will reflect in vivo studies and therefore have clear added value for the prescriber and the patient.
Danish: For det andet vil informationen i produktresuméet om fødevareinteraktioner - i modsætning til alkohol - stamme fra in vivo-undersøgelser og derfor have en klar merværdi for den ordinerende læge og patienten.
English: • The Committee considered that products without a polymethacrylate-triethylcitrate coating as modified-release mechanism do not suggest a significant interaction with alcohol considered to be harmful under normal conditions of use,
Danish: • Udvalget var af den opfattelse, at lægemidler uden polymethacrylat-triethylcitrat-overtræk som mekanisme til modificeret udløsning ikke tyder på en signifikant interaktion med alkohol, der anses for at være skadelig på de normale anvendelsesbetingelser,
English: Whereas
Danish: I alt
English: • The Committee therefore considered that patients exposed to the above mentioned products and concomitant intake of alcohol are at significantly greater risk of developing serious adverse reactions such as respiratory depression and death,
Danish: • Udvalget var derfor af den opfattelse, at patienter, som eksponeres for ovennævnte lægemidler og samtidig indtager alkohol, har en væsentlig større risiko for at udvikle alvorlige bivirkninger, såsom respirationsdepression eller død,
English: Grounds for amendment of the summaries of product characteristics, package leaflets and labelling
Danish: Begrundelser for ændring af produktresuméet, etiketteringen og indlægssedlen
English: • The Committee, based on the published literature, considered that a significant percentage of the patient population using these products does not abstain from alcohol consumption despite the existing warnings and contraindications, and that therefore the existing risk minimisation measures do not adequately address the concern,
Danish: • Udvalget vurderede på baggrund af faglitteraturen, at en væsentlig procentdel af den patientpopulation, der bruger disse lægemidler, ikke afholder sig fra at indtage alkohol på trods af de eksisterende advarsler og kontraindikationer, og at de eksisterende risikominimeringsforanstaltninger derfor ikke i tilstrækkelig grad afhjælper denne betænkelighed,
English: • The Committee considered, however, that as a pharmacodynamic interaction with alcohol may occur, the product information of the above mentioned products should describe in a clear and harmonised manner the pharmacodynamic interaction between opioid products and alcohol,
Danish: • Udvalget var imidlertid af den opfattelse, at produktinformationen for ovennævnte lægemidler, idet der kan forekomme en farmakodynamisk interaktion med alkohol, skal indeholde en klar og harmoniseret beskrivelse af den farmakodynamiske interaktion mellem opioide lægemidler og alkohol,
English: Considering that the proposed pharmacodynamic warning already advises against concomitant use with alcohol, considering also the limitations of the in vitro data and difficulties in its interpretation by prescribers, the majority of the Committee was of the opinion that the addition of a pharmacokinetic interaction warning based on a description of the in vitro data would not favour the clarity of the message to patients and prescribers regarding the need to avoid concomitant use with alcohol.
Danish: I betragtning af at det i den foreslåede farmakodynamiske advarsel allerede frarådes at indtage lægemidlet sammen med alkohol, og i betragtning af at in vitro-dataene er begrænsede, og at de er vanskelige for de ordinerende læger at fortolke, var flertallet i udvalget af den opfattelse, at tilføjelsen af en advarsel om farmakokinetisk interaktion på baggrund af en beskrivelse af in vitro-dataene ikke ville fremme budskabets klarhed til patienter og ordinerende læger, når det gælder nødvendigheden af at undgå samtidig brug med alkohol.
English: Having assessed the detailed grounds for re-examination provided by the MAH, the rapporteurs assessment reports, the conclusions from the ad hoc expert meeting together with the MAH's expressed concerns on the conclusions of the ad hoc expert meeting and all the information submitted during the referral procedure, the CHMP discussed each one of the grounds submitted:
Danish: Efter at have vurderet de detaljerede årsager til en revurdering, som indehaveren af markedsføringstilladelsen havde oplyst, rapportørernes vurderingsrapporter, konklusionerne fra ad hoc-ekspertmødet, de bekymringer, som indehaveren af markedsføringstilladelsen havde givet udtryk for med hensyn til konklusionerne fra ad hoc-ekspertmødet, og alle de oplysninger, der var blevet fremsendt under indbringelsesproceduren, drøftede CHMP de enkelte fremlagte grunde:
English: In its detailed grounds for re-examination the MAH referred to statistical analysis confirming different behaviours in the presence of alcohol for a generic and its originator product.
Danish: I sine detaljerede begrundelser for en revurdering henviste indehaveren af markedsføringstilladelsen til en statistisk analyse, som bekræfter forskellig adfærd ved tilstedeværelse af alkohol for et generisk lægemiddel og originallægemidlet.
English: The MAH further considered, in its grounds for re-examination, that the CHMP opinion was inconsistent in its approach regarding alcohol versus food interactions.
Danish: I sine begrundelser for en revurdering var indehaveren af markedsføringstilladelsen ligeledes af den opfattelse, at CHMP's udtalelse var inkonsekvent i sin tilgang til alkoholinteraktioner kontra fødevareinteraktioner.
English: The CHMP having assessed all the detailed grounds for re-examination and argumentation presented by the MAH and having considered the views of the Rapporteurs, the scientific discussion within the Committee and the conclusions of the ad hoc expert group as well as the concerns raised by the MAH in this respect, concluded that products with a polymethacrylate-triethylcitrate coating are harmful under the normal conditions of use and that, for the remaining products, the Product Information should be amended to include a warning and recommendation for avoiding concomitant use with alcohol.
Danish: Efter at have vurderet alle de detaljerede begrundelser for en revurdering og den argumentation, som indehaveren af markedsføringstilladelsen fremførte, og efter at have taget højde for rapportørernes synspunkter, den videnskabelige drøftelse i udvalget og ad hoc-ekspertgruppens konklusioner samt de bekymringer, som indehaveren af markedsføringstilladelsen havde givet udtryk for i den forbindelse, konkluderede CHMP, at lægemidler med polymethacrylat-triethylcitrat-overtræk er skadelige under de normale anvendelsesbetingelser, og at produktinformationen skal ændres for de resterende lægemidlers vedkommende, så der medtages en advarsel og en anbefaling om at undgå samtidig brug med alkohol.
English: A low number of cases of interaction between alcohol and opioid products have been reported, most reports involved intentional overdose or abuse in conjunction with other products and some were fatal.
Danish: Størstedelen af indberetningerne vedrørte forsætlig overdosis eller misbrug i kombination med andre lægemidler, og nogle havde dødelig udgang.
English: In vivo studies conducted with a hydromorphone formulation based on ammonio methacrylate copolymer type B (Eudragit RS) confirmed the existing in vitro data suggesting that alcohol affects the formulation.
Danish: In vivo-undersøgelser foretaget med en hydromorphonformulering baseret på ammonio methacrylate copolymer type B (Eudragit RS) bekræftede de eksisterende in vitro-data, som indikerede, at formuleringen påvirkedes af alkohol.
English: The CHMP had not addressed the issue of the additional risk to patients posed by modified release formulations of opioids which exhibit a greater vulnerability to alcohol compared with the reference product, whilst conferring no additional patient benefit.
Danish: CHMP havde ikke behandlet spørgsmålet om den yderligere risiko for patienter, som depotformuleringer af opioider udgør, eftersom de viser en større modtagelighed for alkohol sammenlignet med referencelægemidlet, men ikke giver nogen yderligere patientfordele.
English: Overall summary of the scientific evaluation of modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications) (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af orale opioide lægemidler med modificeret udløsning omfattet af niveau III på WHO's skala for smertebehandling (intens vedvarende smerte, som er resistent over for tidligere anvendte lægemidler) (se bilag I)
English: • The Committee took the view that modified-release oral opioid products in the level III of the WHO scale for the management of pain containing a polymethacrylate-triethylcitrate coating as modified-release mechanism are harmful under the normal conditions of use in accordance with article 116 of Directive 2001/83/EC, as amended.
Danish: • Udvalget var af den opfattelse, at orale opioide lægemidler med modificeret udløsning omfattet af niveau III på WHO's skala for smertebehandling med polymethacrylat-triethylcitrat-overtræk som mekanisme til modificeret udløsning er skadelige under normale anvendelsesbetingelser i henhold til artikel 116 i direktiv 2001/83/EF, med senere ændringer.
English: A product containing hydromorphone and a prolonged release system consisting of ammonio methacrylate co-polymer type B (Eudragit RS) also suffered a significant effect of high concentrations of alcohol on in vitro dissolution.
Danish: Et lægemiddel indeholdende hydromorphon og et depotsystem bestående af ammonio methacrylate copolymer type B (Eudragit RS) viste også en signifikant effekt ved høje alkoholkoncentrationer ved in vitro-opløsning.
English: The MAH expressed the view that:
Danish: Ud fra følgende betragtninger:
English: Consequently, the CHMP has recommended the suspension of the marketing authorisation for modified-release oral opioid products in the level III of the WHO scale for the management of pain containing a polymethacrylate-triethylcitrate coating as modified-release mechanism (see annex I).
Danish: CHMP har således anbefalet, at markedsføringstilladelsen for orale opioide lægemidler med modificeret udløsning omfattet af niveau III på WHO's skala for smertebehandling med polymethacrylattriethylcitrat-overtræk som mekanisme til modificeret udløsning suspenderes (se bilag I).
English: This morphine formulation with polymethacrylate- triethylcitrate coating as modified-release mechanism has been identified as a product where dose dumping might occur when taken together with alcohol.
Danish: Denne morfinformulering med polymethacrylat-triethylcitrat-overtræk som mekanisme til modificeret udløsning er blevet identificeret som et lægemiddel, hvor der kan forekomme dosisdumping, når det tages sammen med alkohol.
English: This is justified on the basis that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation.
Danish: Dette begrundes med, at der kan forekomme en farmakodynamisk interaktion mellem opioide lægemidler og alkohol uanset formulering.
English: From the products tested, fifty percent of the formulations were found to be affected by alcohol solutions in vitro.
Danish: Blandt de testede lægemidler blev det påvist, at 50 % af formuleringerne blev påvirket af alkoholopløsninger in vitro.
English: The exception is one morphine formulation using polymethacrylate-triethylcitrate coating as modified-release mechanism, for which dose dumping might occur when taken together with alcohol.
Danish: Undtaget herfra er én morfinformulering, hvor polymethacrylat-triethylcitrat-overtræk anvendes som mekanisme til modificeret udløsning, og hvor dosisdumping kan forekomme, når formuleringen tages sammen med alkohol.
English: In particular, assumptions were made about the behaviour of some formulations based solely on the excipients; in this respect the CHMP did not take into account the evidence provided in the Oral Hearing on 23 June 2010 that such assumptions are flawed.
Danish: I den forbindelse tog CHMP ikke højde for den evidens, der blev givet under den mundtlige høring den 23. juni 2010 for, at sådanne postulater er forkerte.
English: As a consequence, where accelerated drug release is seen, the EWP's recommendation was for label warnings and risk management strategies to be considered.
Danish: Som følge heraf anbefalede EWP at overveje mærkningsadvarsler og risikostyringsstrategier i de tilfælde, hvor der ses en fremskyndet frigivelse af lægemidlet.
English: The dissolution profile of this product (80% dissolved substance within 15 min in 20% alcohol) is beyond the limit of the Ph. Eur.
Danish: Opløsningsprofilen for dette lægemiddel (80 % opløst stof inden for 15 minutter i 20 % alkohol) overskrider grænsen i Den Europæiske Farmakopé for lægemidler med konventionel udløsning (NLT 75 % opløst aktivt stof inden for 45 minutter).
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC, as amended for modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications),
Danish: • Udvalget tog højde for proceduren i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, for orale opioide lægemidler med modificeret udløsning omfattet af niveau III på WHO's skala for smertebehandling (intens vedvarende smerte, som er resistent over for tidligere anvendte lægemidler),
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC, as amended for modified-release oral opioid products in the level III of the WHO scale for the management of pain (intense sustained pain resistant to previous medications) on the EU market,
Danish: • Udvalget tog højde for proceduren i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, for orale opioide lægemidler med modificeret udløsning omfattet af niveau III på WHO's skala for smertebehandling (intens vedvarende smerte, som er resistent over for tidligere anvendte lægemidler) på EU's marked,
English: • The Committee noted that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
Danish: • Udvalget bemærkede, at der kan forekomme en farmakodynamisk interaktion mellem opioide lægemidler og alkohol uanset formulering,
English: For all other strong-opioid modified release oral products in the European market (formulations not containing polymethacrylate-triethylcitrate), no significant risk of dose-dumping due to alcohol use was identified.
Danish: Der blev ikke identificeret nogen væsentlig risiko for dosisdumping på grund af indtagelse af alkohol for nogen andre stærke opioide orale lægemidler med modificeret udløsning på det europæiske marked (formuleringer, som ikke indeholder polymethacrylat-triethylcitrat).
English: • The Committee considered that a pharmacodynamic interaction between opioid products and alcohol may occur irrespective of the formulation,
Danish: • Udvalget var af den opfattelse, at der kan forekomme en farmakodynamisk interaktion mellem opioide lægemidler og alkohol uanset formulering,
English: What is Arikayce?
Danish: Hvad er Arikayce?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 June 2016
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24.
English: The withdrawal letter is available here.
Danish: Brevet om tilbagetrækningen kan ses her.
English: It was to be used in patients whose infection has persisted despite previous treatment.
Danish: Lægemidlet skulle bruges hos patienter, hvis infektion fortsatte på trods af tidligere behandling.
English: It was to be available as a suspension for inhalation.
Danish: Det var hensigten, at det skulle leveres som suspension til inhalation.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you.
Danish: Hvis du deltager i en klinisk undersøgelse med Arikayce og har behov for mere information om din behandling, kan du kontakte den læge, der behandler dig.
English: These liposomes help reduce the rate at which the active substance is broken down, allowing it to remain in the body for longer.
Danish: Liposomerne bidrager til at reducere den hastighed, med hvilken det aktive stof nedbrydes, og det gør det muligt for stoffet at blive i kroppen i længere tid.
English: What was Arikayce expected to be used for?
Danish: Hvad forventedes Arikayce anvendt til?
English: Withdrawal of the marketing authorisation application for Arikayce (amikacin) EMA/430267/2016
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Arikayce (amikacin) EMA/430267/2016
English: How is Arikayce expected to work?
Danish: Hvordan forventes Arikayce at virke?
English: Withdrawal of the marketing authorisation application for Arikayce (amikacin)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Arikayce (amikacin)
English: The company submitted results of an early (phase 2) study in 89 adult patients with lung infections caused by MAC or similar bacteria.
Danish: Virksomheden indsendte resultaterne af en tidlig undersøgelse (fase 2) af 89 voksne patienter med lungeinfektion forårsaget af MAC eller lignende bakterier.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Danish: Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, virksomheden havde fremlagt, og udarbejdet en liste med spørgsmål.
English: On 8 June 2016, Insmed Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Arikayce intended for the treatment of Mycobacterium avium complex (MAC) lung disease.
Danish: Den 8. juni 2016 meddelte Insmed Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Arikayce til behandling af lungesygdommen Mycobacterium avium complex (MAC) tilbage.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af den sidste runde spørgsmål, var der fortsat visse uafklarede punkter.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Arikayce did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Arikayce ikke opvejede risiciene.
English: Because the medicine is breathed in, it also reaches the lungs more directly than amikacin given by injection.
Danish: Da lægemidlet inhaleres, når det lungerne på en mere direkte måde end ved injektion.
English: Further information on the orphan designation can be found here.
Danish: Yderligere oplysninger om udpegelsen til lægemiddel til sjældne sygdomme findes her.
English: Arikayce is an antibiotic containing the active substance amikacin.
Danish: Arikayce er et antibiotikum, der indeholder det aktive stof amikacin.
English: The Committee's main concern was that the study submitted in the application did not provide enough evidence that Arikayce can permanently clear the bacteria from patients' sputum.
Danish: Udvalgets primære bekymring var, at den undersøgelse, der var blevet anvendt i ansøgningen, ikke indeholdt beviser nok for, at Arikayce permanent kan fjerne bakterierne fra patienternes ophost.
English: Arikayce was expected to be used to treat adults with a lung infection caused by Mycobacterium avium complex (MAC), a group of bacteria commonly found in the environment, such as in soil and water.
Danish: Arikayce var beregnet til at behandle voksne patienter med en lungeinfektion forårsaget af Mycobacterium avium complex (MAC), der er en gruppe bakterier, som findes i miljøet, f.eks. i jorden og i vand.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials for Arikayce.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Arikayce.
English: In its letter notifying the Agency of the withdrawal, the company stated that its decision is based on the understanding that CHMP was not going to recommend approval of the medicine on the basis of current data.
Danish: I det brev, hvori virksomheden orienterer Udvalget om, at den trækker ansøgningen tilbage, angiver virksomheden, at dens beslutning er baseret på den opfattelse, at CHMP ikke ville anbefale godkendelsen af lægemidlet på grundlag af de aktuelle data.
English: The active substance in Arikayce, amikacin, is a well-established antibiotic of the group ‘aminoglycosides' that works by disrupting bacterial production of vital proteins.
Danish: Det aktive stof i Arikayce, amikacin, er et velkendt antibiotikum i gruppen af aminoglykosider, som virker ved at forstyrre bakteriernes produktion af vitale proteiner.
English: Based on the review of the data and the company's response to the CHMP lists of questions, the CHMP was of the provisional opinion that Arikayce could not be approved for the treatment of MAC lung infection.
Danish: På baggrund af gennemgangen af dataene og firmaets svar på CHMP's liste med spørgsmål var CHMP af den foreløbige opfattelse, at Arikayce ikke kunne godkendes til behandling af MAC-lungeinfektion.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Arikayce?
English: Arikayce was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 8 April 2014 for treating infections caused by MAC and similar bacteria.
Danish: Arikayce blev udpeget som lægemiddel til sjældne sygdomme den 8. april 2014 til behandling af infektioner forårsaget af MAC og lignende bakterier.
English: This study compared Arikayce with placebo (a dummy treatment) and looked mainly at how effectively the medicine cleared bacteria from patients' sputum (phlegm) after about 3 months of treatment.
Danish: I denne undersøgelse blev Arikayce sammenlignet med placebo (et ikke-aktivt stof), og et af hovedformålene med undersøgelsen var at undersøge, hvor effektivt lægemidlet fjerner bakterier fra patienternes opspyt efter 3 måneders behandling.
English: In this medicine, amikacin is contained within microscopic fat capsules known as liposomes.
Danish: I dette lægemiddel er amikacin indeholdt i liposomer, dvs. mikroskopiske fedtkapsler.