FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant shall undertake a DUS to follow the use of prescribed dexamfetamine in the European Union using multiple data sources.
Danish: Ansøgeren foretager en undersøgelse af lægemiddelanvendelse med henblik på at overvåge anvendelsen af dexamfetamin, der ordineres i EU, ved hjælp af en række datakilder.
English: 2. annex 2 should include the proposed text of the package leaflet in addition to the proposed SmPC.
Danish: Bilag 2 skal indeholde den foreslåede tekst til indlægssedlen foruden det foreslåede produktresumé.
English: 4. part III, pharmacovigilance plan: category 1 should be added for the PASS and the DUS.
Danish: Del III, lægemiddelovervågningsplan: Der tilføjes kategori 1 til sikkerhedsundersøgelse efter markedsføring og undersøgelsen af lægemiddelanvendelse.
English: The applicant shall submit an updated RMP taking into consideration the following recommendations: 1. section VI.2.5 Documentation for public summary should include a summary of risk minimisation measures by safety concern.
Danish: Punkt VI.2.5: Dokumentationen til sammendraget for offentligheden skal indeholde et sammendrag af risikominimeringsforanstaltningerne for hvert enkelt sikkerhedsproblem.
English: The mean age was 70.2 and 71.6 years, respectively.
Danish: Gennemsnitsalderen var henholdsvis 70,2 og 71,6 år.
English: This opinion supersedes the opinion on temporary measures adopted on 4 July 2011.
Danish: Denne udtalelse erstatter udtalelsen om midlertidige foranstaltninger, der blev vedtaget den 4. juli 2011.
English: The procedure started during the February 2011 CHMP meeting.
Danish: Proceduren begyndte på CHMP's møde i februar 2011.
English: The need to consider renal function was also introduced.
Danish: Nødvendigheden af at tage hensyn til nyrefunktionen blev ligeledes indført.
English: Annex II Scientific conclusions and grounds for the suspension of the marketing and use of the products presented by the EMA
Danish: Bilag II Videnskabelige konklusioner og begrundelse for suspendering af markedsføringen og anvendelsen af produkter fremlagt af EMA
English: Grounds for the suspension of the Marketing Authorisations
Danish: Begrundelse for suspenderingen af markedsføringstilladelserne
English: Buflomedil-containing medicines are authorised and marketed in 12 EU countries by national procedures and were first authorised in France in 1974.
Danish: Lægemidler indeholdende buflomedil er godkendt og markedsføres i 12 EU-medlemsstater efter nationale procedurer og blev først godkendt i Frankrig i 1974.
English: Overall summary of the scientific evaluation of buflomedil-containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler indeholdende buflomedil (se bilag I)
English: As a result, a procedure under Article 107 of Directive 2001/83/EC, as amended was automatically initiated.
Danish: Dette medførte automatisk indledning af en procedure i henhold til artikel 107 i direktiv 2001/83/EF, med senere ændringer.
English: Safety of the injectable formulations of buflomedil
Danish: Sikkerheden af injektionsvæskeformuleringerne af buflomedil
English: The concerns regarding the rapid deterioration of renal function in these patients, requiring regular and frequent monitoring were also reiterated.
Danish: Betænkelighederne vedrørende den hurtige nedsættelse af nyrefunktionen hos disse patienter, som kræver regelmæssig og hyppigt overvågning, blev ligeledes fremført på ny.
English: Discussion on safety
Danish: Diskussion af sikkerhed
English: These reported 188 and 26 patients respectively who experienced AEs.
Danish: Der blev heri indberettet henholdsvis 188 og 26 patienter, som fik bivirkninger.
English: Following an oral explanation held in July 2011, the MAH was requested to propose further risk minimisation measures and asked whether a restricted population could be identified.
Danish: Efter en mundtlig redegørelse i juli 2011 blev indehaveren af markedsføringstilladelsen anmodet om at foreslå yderligere foranstaltninger til risikominimering og blev spurgt, om der kunne udpeges en indskrænket population.
English: The study compared a reference period of 6 months before the 2006 French evaluation with two 6-months evaluation periods following the implementation of the resulting RMMs and the circulation of a DHPC.
Danish: I undersøgelsen sammenlignedes en 6 måneders referenceperiode fra før den franske 2006-vurdering med to 6måneders evalueringer, der blev gennemført efter implementering af de resulterende risikostyringsforanstaltninger og udsendelse af en DHPC.
English: Overall summary on safety and on risk minimisation measures
Danish: Samlet resumé vedrørende sikkerhed og foranstaltninger til risikominimering
English: Consequently, the CHMP recommended to the European Commission the suspension of the Marketing Authorisations of buflomedil-containing medicinal products listed in Annex I of the Opinion in all concerned EU Member States.
Danish: anbefalede CHMP Europa-Kommissionen at suspendere markedsføringstilladelserne for de lægemidler indeholdende buflomedil, der er nævnt i udtalelsens bilag 1, i samtlige berørte EU medlemsstater.
English: Thalès observational drug utilisation study
Danish: Thalès-undersøgelsen af lægemiddelanvendelse
English: If dose-adaptation is not done correctly, this leads to serious and lifethreatening toxicity.
Danish: Finder dosistilpasning ikke sted, medfører det alvorlig og livstruende toksisk virkning.
English: In December 2010, a further French benefit-risk evaluation of buflomedil was carried out, following which the French National Competent Authority suspended all French Marketing Authorisations for buflomedil-containing products.
Danish: I december 2010 foretog Frankrig endnu en risk/benefit-vurdering af buflomedil, hvorefter de kompetente franske myndigheder suspenderede alle franske markedsføringsgodkendelser for produkter indeholdende buflomedil.
English: One patient experienced convulsions after taking two 300 mg tablets at the same time instead of two tablets BID.
Danish: Én patient fik kramper efter at have taget to 300 mg tabletter samtidigt i stedet for to gange dagligt.
English: For the lifting of the suspension, the Marketing Authorisation Holders should provide convincing data to identify a population in which the benefits of buflomedil clearly outweigh its identified risks (see Annex III).
Danish: For at opnå ophævelse af suspenderingen skal indehaverne af markedsføringstilladelserne fremlægge overbevisende data til udpegelse af en patientpopulation, hos hvem fordelene ved buflomedil klart overstiger de fundne risici (se bilag III).
English: The CHMP also noted the two French pharmacovigilance enquiries covering the period 1998 to 2004 and 2006 to 2009.
Danish: CHMP noterede sig desuden de to franske undersøgelser af data fra lægemiddelovervågning i perioden 1998-2004 og 2006-2009.
English: Various indications previously registered across the EU were deleted and the indication was restricted to the Symptomatic treatment of chronic peripheral vascular disease (stage 2) (intermittent claudication), bringing it in line with the French SmPC.
Danish: Der blev slettet en række indikationer, der tidligere var registreret på tværs af EU, og indikationen blev begrænset til symptomatisk behandling af kronisk perifer vaskulær sygdom (stadium 2) (claudicatio intermittens)), hvilket bragte den på linje med det franske produktresumé.
English: The CHMP noted that the MAH did not propose to withdraw the 300 mg tablets formulation.
Danish: CHMP konstaterede, at indehaveren af markedsføringstilladelsen ikke foreslog at trække 300 mg tabletten tilbage.
English: Overall conclusions on safety
Danish: Samlede konklusioner vedrørende sikkerhed
English: However, the CHMP noted that the analysis did not demonstrate statistical significance and that the results therefore did not allow to conclude on a statistically significant reduction in the combined primary endpoint compared to placebo.
Danish: CHMP konstaterede dog, at resultatet ikke var statistisk signifikant, så det kunne ikke konkluderes, at der var en statistisk signifikant reduktion i det kombinerede primære endepunkt i forhold til placebo.
English: The CHMP noted that of the 24 reported cases (about 5% of all adverse drug reactions recorded in the MAH database), a majority (13 out of 24) were cases of accidental overdose.
Danish: CHMP noterede sig, at ud af de 24 rapporterede tilfælde (ca. 5 % af alle bivirkninger registreret i databasen hos indehaveren af markedsføringstilladelsen) vedrørte størstedelen (13 ud af 24) accidentel overdosering.
English: The study showed that about 30% of patients with renal failure still receive an excessive dose, although it was noted that this had decreased from 75% prior to the DHPC.
Danish: Undersøgelsen viste, at ca. 30 % af alle patienter med nyreinsufficiens fortsat får for stor dosis, skønt det bemærkedes, at denne procentdel var aftaget fra 75 % procent før udsendelsen af den pågældende DHPC.
English: Buflomedil is currently approved in France in the treatment of ”symptomatic peripheral arterial occlusive disease (PAOD Stage II) symptoms”.
Danish: Buflomedil er på nuværende tidspunkt godkendt i Frankrig til behandling af "symptomer på symptomatisk perifer arteriel okklusiv sygdom-2 (PAOD Stage II)".
English: In addition, review of all available individual case safety data related to buflomedil identified 28 cases of overdoses in elderly patients (over 65
Danish: Ved gennemgang af alle foreliggende individuelle patientsikkerhedsdata for buflomedil fandtes desuden 28 tilfælde med overdosering af ældre patienter (over 65 år).
English: There were 6 cases of cardiovascular and 6 cases of neurological serious adverse events.
Danish: Der var seks tilfælde af alvorlige kardiovaskulære og seks tilfælde af alvorlige neurologiske bivirkninger.
English: Discussion on efficacy
Danish: Diskussion af virkning
English: In 70% of the cases, the dose of buflomedil received by the patients was inappropriate because of underlying renal failure.
Danish: I 70 % af disse tilfælde var den anvendte dosis af buflomedil uhensigtsmæssig som følge af underliggende nyreinsufficiens.
English: Regarding the proposed additional pharmacovigilance activities, the CHMP was of the opinion that signal detection is no longer a priority, given that the risks associated with buflomedil are now identified and confirmed.
Danish: Vedrørende den foreslåede supplerende lægemiddelovervågning var det CHMP's opfattelse, at signaldetektion ikke længere er en prioritet, nu hvor risiciene knyttet til buflomedil er kortlagt og bekræftet.
English: The CHMP also examined a review of all available individual case safety data related to buflomedil, conducted by the MAH, based on post-marketing safety data from Abbott Laboratories' global safety database and Amdipharm's safety database, published medical literature (worldwide) and from a number of other sources, including Toxicology/Poison Control Centres and Regulatory Authorities.
Danish: CHMP gennemgik endvidere dels en oversigt over alle foreliggende individuelle patientsikkerhedsdata vedrørende buflomedil, der af indehaveren af markedsføringstilladelsen var udarbejdet på grundlag af sikkerhedsdata efter markedsføring fra Abbott Laboratories' globale sikkerhedsdatabase og Amdipharms sikkerhedsdatabase, dels publiceret medicinsk litteratur (globalt) og dels en række andre kilder, herunder toksikologiske centre/giftcentre og tilsynsmyndigheder.
English: Serious cardiovascular and neurological adverse events under normal conditions of use
Danish: Alvorlige kardiovaskulære og neurologiske bivirkninger under normale anvendelsesbetingelser
English: The CHMP acknowledged that variations to implement the European harmonisation of the SmPC are still ongoing in some countries but noted that the RMP proposed by Amdipharm in May 2010 was largely equivalent to the RMPs already implemented in France.
Danish: CHMP var vidende om, at ændringsansøgninger til gennemførelse af den europæiske harmoniseret produktresumé stadig er under behandling i visse lande, men konstaterede, at den af Amdipharm i maj 2010 foreslåede risikostyringsplan stort set svarer til dem, der allerede er indført i Frankrig.
English: The approved maximum daily dose in patients with normal renal function is 600 mg and 300 mg in patients with renal impairment.
Danish: Den godkendte maksimale daglige dosis er 600 mg til patienter med normal nyrefunktion, og 300 mg til patienter med nedsat nyrefunktion.
English: In addition, the CHMP observed with concern that an initial assessment of renal function was only carried out in 20% of patients and that measurements of creatinine clearance were only performed in 17% of patients, despite the SmPC recommendations.
Danish: Desuden konstaterede CHMP med betænkelighed, at indledende vurdering af nyrefunktionen kun fandt sted hos 20 % af patienterne, og at kreatininclearance kun blev målt hos 17 % af patienterne trods anbefalingen herom i produktresuméet.
English: The MAH review of the ICSR database identified 5 cases with known dosage occurring in elderly patients for whom dosage adjustment was required.
Danish: Ved den af indehaveren af markedsføringstilladelsen foretagne gennemgang af ICSR-databasen fandtes 5 tilfælde med kendt dosering til ældre patienter, som krævede dosisjustering.
English: Serious cardiovascular and neurological adverse events in elderly patients and patients with renal impairment
Danish: Alvorlige kardiovaskulære og neurologiske bivirkninger hos ældre patienter og patienter med nedsat nyrefunktion
English: In addition, 32 cardiological adverse events were retrieved; the most frequent reactions were tachycardia, hypertension, flushing and hypotension.
Danish: Derudover fandtes 32 tilfælde med kardiologiske bivirkninger, hvoraf de hyppigste var takykardi, hypertension, blussen og hypotension.
English: The CHMP was of the opinion that this data showed the risks associated with buflomedil in view of its narrow therapeutic margin.
Danish: Det var CHMP's opfattelse, at disse data viser de risici, der er knyttet til buflomedil i lys af dets smalle terapeutiske margin.
English: The CHMP concluded that the impact of the implemented measures was very weak and that the expected impact of the proposed measures was insufficient to adequately address the identified risks observed with buflomedil.
Danish: CHMP konkluderede, at de gennemførte foranstaltninger kun havde haft meget ringe virkning, og at den forventede virkning af de foreslåede foranstaltninger var utilstrækkelig til at imødegå de fundne risici ved brug af buflomedil på betryggende vis.
English: Following these enquiries, France took a number of national regulatory actions to minimise the risk of adverse events associated with buflomedil.
Danish: Efter disse undersøgelser traf tilsynsmyndighederne i Frankrig en række nationale foranstaltninger til mindskelse af risikoen for bivirkninger relateret til buflomedil.
English: • The Committee considered that a number of serious cardiac and neurological adverse events have been reported with the use of buflomedil under normal conditions of use, particularly in elderly patients.
Danish: • Udvalget tog i betragtning, at der er indberettet en række alvorlige kardiale og neurologiske bivirkninger i forbindelse med brug af buflomedil under normale anvendelsesbetingelser, navnlig hos ældre patienter,
English: Overall benefit-risk assessment
Danish: Samlet vurdering af benefit/risk-forholdet
English: • The Committee therefore considered that the risk-benefit balance of buflomedil-containing medicinal products is not positive under normal conditions of use.
Danish: • udvalget vurderede derfor, at benefit/risk-forholdet for lægemidler indeholdende buflomedil ikke er gunstigt under normale anvendelsesbetingelser,
English: The CHMP also carried out a separate assessment of the safety of the parenteral formulations of buflomedil, which are used in the hospital setting for the treatment of severe chronic ischaemia of the lower limbs.
Danish: CHMP foretog desuden en separat vurdering af sikkerheden af de parenterale buflomedilformuleringer, der anvendes på hospitaler til behandling af svær kronisk iskæmi af underekstremiteterne.
English: The CHMP also noted the MAH proposal to reduce the pack size, to minimise the consequences of an intentional overdose.
Danish: CHMP noterede sig desuden forslaget fra indehaveren af markedsføringstilladelsen om at mindske pakningsstørrelsen for at minimere følgerne af forsætlig overdosering.
English: • The Committee considered, based on the assessment of the impact of risk minimisation measures already implemented in some Member States and on the published literature, that the risk minimisation measures proposed by the Marketing Authorisation Holder would not be able to adequately reduce the risks of serious adverse events to a clinically acceptable level.
Danish: • på grundlag af en vurdering af virkningen af de i nogle medlemsstater allerede gennemførte foranstaltninger til risikominimering og af den publicerede litteratur fandt udvalget, at de af indehaveren af markedsføringstilladelsen påtænkte foranstaltninger til risikominimering ikke vil være tilstrækkelige til at mindske risiciene for alvorlige bivirkninger til et klinisk acceptabelt niveau,
English: • The Committee considered that buflomedil-containing medicinal products showed only limited clinical efficacy in the symptomatic treatment of chronic peripheral vascular disease.
Danish: • udvalget vurderede, at lægemidler indeholdende buflomedil kun udviste begrænset klinisk virkning til symptomatisk behandling af kroniske perifere kredsløbsforstyrrelser,
English: The CHMP was of the opinion that despite this reduction, the percentage of patients at risk remained unacceptably high.
Danish: CHMP fandt procentdelen af udsatte patienter uacceptabelt høj trods denne reduktion.
English: The CHMP also noted the results of the Thalès observational drug utilisation study, including 300 000 patients and conducted to assess the impact of the RMMs implemented in France on prescription patterns.
Danish: CHMP noterede sig endvidere resultaterne af Thalès-undersøgelsen af lægemiddelanvendelse, der omfattede 300 000 patienter og havde til formål at vurdere, hvordan ordinationsmønsteret blev påvirket af de risikostyringsforanstaltninger, der var implementeret i Frankrig.
English: The CHMP noted the efficacy data submitted by the MAH, including the relatively recent large placebocontrolled LIMB (Limbs International Medicinal Buflomedil) study.
Danish: CHMP gennemgik de af indehaveren af markedsføringstilladelsen fremlagte data om virkning, herunder den forholdsvis nye store placebokontrollerede LIMB-undersøgelse (Limbs International Medicinal Buflomedil).
English: Following a European PSUR assessment and a full benefit-risk assessment completed by the MAH in January 2010, the MAH proposed a number of measures to address the identified concerns.
Danish: Efter en europæisk PSUR-vurdering og en gennemgribende risk/benefit-vurdering foretaget af indehaveren af markedsføringstilladelsen i januar 2010 foreslog indehaveren af markedsføringstilladelsen en række foranstaltninger til imødegåelse af de fundne problemer.
English: From these cases, a total of 12 cases were identified in which patients were treated within the maximum therapeutic range (i.e. up to 600 mg daily) of buflomedil.
Danish: Blandt tilfældene var der i alt 12, hvor dosis ikke havde oversteget det maksimale terapeutiske område (dvs. op til 600 mg dagligt) for buflomedil.
English: According to the approved indication, the injection formulation of buflomedil is used to initiate PAOD therapy, to be followed by a switch to oral therapy.
Danish: Ifølge den godkendte indikation anvendes den parenterale formulering af buflomedil til initiering af behandlingen af PAOD, hvorefter patienten overgår til oral behandling.
English: These risks are compounded by the fact that buflomedil is a substance with a narrow therapeutic index and that buflomedil treatment requires dose-adaptation to adjust for renal function.
Danish: Disse risici forstærkes af det forhold, at buflomedil har et smalt terapeutisk indeks og kræver tilpasning af dosis efter nyrefunktionen.
English: As a result, when addressing the risk-benefit of buflomedil under normal conditions for use, the CHMP assumed a switch to oral formulations and therefore considered that the risk/benefit of buflomedil injectable needs to be considered within the overall discussion of the risk-benefit of buflomedil.
Danish: Ved analysen af risk/benefit-forholdet for buflomedil under normale anvendelsesbetingelser forudsatte CHMP, at der blev skiftet til orale formuleringer, og var derfor af den opfattelse, at risk/benefit-forholdet for buflomedil injektionsvæske må vurderes som led i den overordnede diskussion af risk/benefit-forholdet for buflomedil.
English: Although the 12 cases were complicated by underlying clinical conditions and other concomitant medications, the CHMP considered them to confirm the risk of serious adverse events associated with the use of buflomedil under normal conditions of use.
Danish: Skønt disse 12 tilfælde var kompliceret af underliggende sygdomme og samtidig anden medicinering, vurderede CHMP, at de bekræftede risikoen for alvorlige bivirkninger relateret til buflomedil under normale anvendelsesbetingelser.
English: Buflomedil is an α1-, α2-adrenolytic agent with vasoactive and haemorheologic properties, improving the blood flow in the microcirculation as well as tissue oxygenation.
Danish: Buflomedil er en 1-, 2-adrenoceptorantagonist, hvis vasoaktive og hæmoreologiske egenskaber øger blodgennemstrømningen i mikrokredsløbet og iltningen af vævet.
English: In addition, the CHMP noted the evidence of limited clinical efficacy of buflomedil, as demonstrated in recent clinical trials.
Danish: CHMP noterede sig desuden dokumentationen for den begrænsede kliniske virkning af buflomedil, som demonstreres af de seneste kliniske undersøgelser.
English: Consequently, while the efficacy remains largely unchanged since the granting of the initial MA, the CHMP was of the opinion that the available evidence is not supportive of a significant clinical efficacy of buflomedil on cardiovascular events and on walking distance.
Danish: Virkningen er således i det store hele uændret siden udstedelsen af den oprindelige markedsføringstilladelse, og det er CHMP's opfattelse, at den foreliggende dokumentation ikke støtter, at buflomedil har nogen væsentlig klinisk virkning på kardiovaskulære hændelser og gangdistance.
English: France previously conducted two pharmacovigilance and toxicovigilance investigations following reports of nervous system and cardiac serious adverse events (SAEs) associated with the use of buflomedil.
Danish: Frankrig har tidligere foretaget to undersøgelser af lægemiddelovervågning og toksikologisk overvågning, efter at der var indberettet om alvorlige neurologiske og kardiale bivirkninger relateret til brug af buflomedil.
English: • The Committee raised concerns regarding the rapid deterioration of renal function in patients with peripheral vascular disease, requiring regular and frequent monitoring.
Danish: • udvalget udtrykte betænkelighed ved, at der hos patienter med perifer vaskulær sygdom forekommer et hurtigt fald i nyrefunktionen, som kræver regelmæssig og hyppig overvågning,
English: Regarding the LIMB study, the results indicated a trend of a decrease in symptoms (symptomatic deterioration of PAOD, amputations) although there was an increase in cardiovascular events (MI, stroke, CV deaths).
Danish: LIMB-undersøgelsen viste en tendens til bedring af symptomer (symptomatisk forværring af PAOD, amputationer), men der var en stigning i kardiovaskulære hændelser (myokardieinfarkt, slagtilfælde, kardiovaskulært betingede dødsfald).