FrancophonIA/ELRC3.0 huggingface dataset:
English: Only limited pharmacokinetic data are available in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Danish: Der er kun begrænsede farmakokinetiske data vedrørende patienter med svær nyreinsufficiens
English: - Zoledronic acid Actavis is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Danish: Infusionen bør vare mindst 15 minutter og skal gives som en enkelt intravenøs infusion i en separat infusionsslange.
English: What Zoledronic acid Actavis is and what it is used for
Danish: Zoledronsyre Actavis, anvendt som indikeret under pkt.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvid du ønsker yderligere oplysninger om Zoledronsyre Actavis, skal du henvende dig til den lokale repræsentant:
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel 1A Pharma to Acino Pharma GmbH on 28 July 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel 1A Pharma til Acino Pharma GmbH den 28. juli 2009.
English: In acute coronary syndrome, Clopidogrel 1A Pharma is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Danish: Ved akut koronarsyndrom anvendes Clopidogrel 1A Pharma sammen med aspirin, og behandlingen indledes almindeligvis med en startdosis på fire 75 mg-tabletter.
English: The standard dose of Clopidogrel 1A Pharma is one 75 mg tablet once a day, taken with or without food.
Danish: Standarddosis af Clopidogrel 1A Pharma er 75 mg en gang dagligt med eller uden et måltid.
English: Clopidogrel 1A Pharma is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel 1A Pharma anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: Clopidogrel 1A Pharma can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the electrocardiogram or ECG) when the doctor thinks that they would benefit from the treatment.
Danish: Clopidogrel 1A Pharma kan anvendes til patienter, som har myokardieinfarkt med ”forhøjelse af STsegmentet” (ST-elevation), dvs. en unormal visning på elektrokardiogrammet (EKG), når lægen vurderer, at patienterne kan have gavn af denne behandling.
English: This means that Clopidogrel 1A Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel 1A Pharma er identisk med et referencelægemiddel, der allerede er godkendt i Den Europæiske Union, kaldet Plavix.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel 1A Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel 1A Pharma i overensstemmelse med EU-kravene har vist sig at være af sammenlignelig kvalitet og at være bioækvivalent med Plavix.
English: • patients with peripheral arterial disease (problems with blood flow in the arteries);
Danish: • patienter med perifere kredsløbsforstyrrelser (problemer med blodgennemstrømningen i
English: Clopidogrel 1A Pharma can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel 1A Pharma kan påbegyndes få dage efter anfaldet og indtil 35 dage efter,
English: Because Clopidogrel 1A Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Clopidogrel 1A Pharma er et generisk lægemiddel, der er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Clopidogrel 1A Pharma is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel 1A Pharma er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: Because Clopidogrel 1A Pharma is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel 1A Pharma er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: What are the benefit and risk of Clopidogrel 1A Pharma?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel 1A Pharma?
English: The full EPAR for Clopidogrel 1A Pharma can be found here.
Danish: Den fuldstændige EPAR for Clopidogrel 1A Pharma findes her.
English: Clopidogrel 1A Pharma can be started between seven days and six months after
Danish: Behandlingen med Clopidogrel 1A Pharma kan påbegyndes 7 dage efter slagtilfældet og indtil 6 måneder efter,
English: The active substance in Clopidogrel 1A Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel 1A Pharma, clopidogrel, er et blodpladeaggregationshæmmende middel.
English: Clopidogrel 1A Pharma is a ‘generic medicine'.
Danish: Det fås som Clopidogrel 1A er et ‘generisk lægemiddel'.
English: Clopidogrel 1A Pharma clopidogrel EPAR summary for the public
Danish: Clopidogrel 1A Pharma clopidogrel
English: How is Clopidogrel 1A Pharma used?
Danish: Hvordan anvendes Clopidogrel 1A Pharma?
English: The Committee recommended that Clopidogrel 1A Pharma be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel
English: Clopidogrel 1A Pharma can be given to the following groups of patients:
Danish: Clopidogrel 1A Pharma kan gives til
English: What is Clopidogrel 1A Pharma?
Danish: Hvordan virker Clopidogrel 1A Pharma?
English: Results are heterogeneous and inconsistent.
Danish: Resultaterne var heterogene og inkonsekvente.
English: Available data is in fact indicative of such causal relationship.
Danish: Tilgængelige data tyder faktisk på en sådan årsagssammenhæng.
English: Its effect results mainly from its α1-blocking properties.
Danish: Dets virkning skyldes primært dens α1blokerende egenskaber.
English: Benefit -risk balance
Danish: Benefit/risk-forholdet
English: It produces a decrease in blood pressure and an increase in peripheral blood flow.
Danish: Det giver et fald i blodtrykket og en stigning i det perifere blodomløb.
English: The seriousness of such adverse effects and their possible fatal outcome is underlined.
Danish: Sådanne bivirkningers sværhedsgrad og deres mulige dødelige udfald understreges.
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC, the CHMP recommends:
Danish: Derfor anbefaler CHMP i henhold til artikel 116 i direktiv 2001/83/EF følgende:
English: Under-reporting can also be suspected because the substance has been on the market for a long time and because fibrosis is already mentioned as an undesirable effect in the product information.
Danish: Underrapportering kan også mistænkes, fordi stoffet har været på markedet i lang tid, og fordi fibrose allerede er nævnt som en bivirkning i produktinformationen.
English: Grounds for the variation/suspension to the terms of the marketing authorisations
Danish: Begrundelser for ændring/suspendering af betingelserne for markedsføringstilladelserne
English: Overall summary of the scientific evaluation of dihydroergocristine containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder dihydroergocristin (se bilag I).
English: In Europe, dihydroergocristine is also available in combination with etofyllinum.
Danish: I Europa fås dihydroergocristin også i kombination med etofyllinum.
English: On 18 January 2012, France triggered a referral under Article 31 of Directive 2001/83/EC for the following ergot derivatives containing medicinal products: dihydroergocryptine/caffeine, dihydroergocristine, dihydroergotamine, dihydroergotoxine and nicergoline.
Danish: Den 18. januar 2012 indbragte Frankrig en sag i henhold til artikel 31 i direktiv 2001/83/EF for følgende lægemidler, der indeholder ergotderivater: dihydroergocryptin/koffein, dihydroergocristin, dihydroergotamin, dihydroergotoxin og nicergolin.
English: There were 3 placebo controlled studies with a study population of 200-240 patients.
Danish: Der var 3 placebokontrollerede undersøgelser med en undersøgelsespopulation på 200-240 patienter.
English: • The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergocristine in the currently assessed indications is very limited, and therefore the potential benefit for patients in these indications is outweighed by the above identified risk.
Danish: • Udvalget er af den opfattelse, at beviserne for klinisk signifikant virkning af dihydroergocristin i de aktuelt vurderede indikationer er meget begrænsede, hvorfor den potentielle fordel for patienter i disse indikationer opvejes af de ovenfor identificerede risici.
English: The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergocristine.
Danish: CHMP har gennemgået de samlede tilgængelige data om dihydroergocristins sikkerhed og virkning.
English: However, in this study with adequate methodological quality standard, non-significant difference between dihydroergocristine + raubasine and placebo groups was observed.
Danish: I denne undersøgelse, der lever op til en tilstrækkelig metodisk kvalitet, blev der imidlertid observeret en ikke-signifikant forskel mellem dihydroergocristin + raubasin-gruppen og placebogruppen.
English: The CHMP was therefore requested to give its opinion on whether the marketing authorisations for ergot derivatives containing medicinal products should be maintained, varied, suspended or withdrawn in relation to the below mentioned indications:
Danish: CHMP blev derfor anmodet om at afgive en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler, der indeholder ergotderivater, bør opretholdes, ændres, suspenderes eller tilbagekaldes for så vidt angår de nedenfor angivne indikationer:
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products in the concerned indications.
Danish: • Udvalget vurderede proceduren i henhold til artikel 31 i direktiv 2001/83/EF for lægemidler, der indeholder ergotderivater, ved de berørte indikationer.
English: The CHMP was of the opinion that no efficacy conclusion could be drawn based on these studies.
Danish: CHMP var af den opfattelse, at der ud fra disse undersøgelser ikke kunne drages nogen konklusion om virkningen.
English: Of these, 18 concerned placebocontrolled trials, 2 concerned actively-controlled trials and 7 concerned open label studies.
Danish: Af disse var 18 placebokontrollerede undersøgelser, 2 var aktivt kontrollerede undersøgelser, og 7 var åbne undersøgelser.
English: A review of all other available data (i.e. literature data, pre-clinical data, and other clinical data including epidemiological studies) that were relevant to evaluate the risk of fibrosis was provided where possible.
Danish: En gennemgang af alle andre tilgængelige data (dvs. litteraturoplysninger, prækliniske data og andre kliniske data, herunder epidemiologiske undersøgelser) af relevans for vurderingen af risikoen for fibrose blev tilvejebragt i det omfang, det var muligt.
English: Although some of the proposed measures could help identify patients with pre-existing fibrosis, relevant concomitant medication and increased risk, the Committee pointed out that they are insufficient to avoid that some patients develop fibrosis and ergotism during treatment.
Danish: Skønt enkelte af de foreslåede foranstaltninger kunne medvirke til at identificere patienter med præeksisterende fibrose, relevant samtidig lægemiddelbehandling og øget risiko, påpegede udvalget, at foranstaltningerne ikke er tilstrækkelige til at undgå, at nogle patienter under behandlingen udvikler fibrose og ergotisme.
English: • Orthostatic hypotension
Danish: • otostatisk hypotension
English: In six of the evaluable studies with population under 100 patients there were similar findings.
Danish: Lignende resultater foreligger fra seks af de evaluérbare undersøgelser med en population på under 100 patienter.
English: Of the 6 randomised, double blind, placebo-controlled studies, 5 studies were not considered relevant by the CHMP because the definition of the diagnosis was not standardised, no primary efficacy criterion was selected among the multi-dimensional assessment, the number of patients per group was small (from 47 to 65), and the treatment duration was short (2 and 3 months).
Danish: Af de 6 randomiserede, dobbeltblinde, placebokontrollerede undersøgelser vurderede CHMP, at 5 undersøgelser ikke var relevante, fordi definitionen af diagnosen ikke var standardiseret, fordi intet primært effektkriterium blev udvalgt blandt den multidimensionale vurdering, fordi antallet af patienter pr. gruppe var lille (47-65), og fordi behandlingsvarigheden var kort (2 og 3 måneder).
English: (excluding Alzheimer's disease and other dementia)
Danish: Alzheimers sygdom og anden demens)
English: Moreover, it was pointed out that topical instillations of dihydroergocristine are out of the scope of this procedure.
Danish: Desuden blev det påpeget, at topiske instillationer med dihydroergocristin ligger uden for denne procedures anvendelsesområde.
English: The group highlighted that the claimed indication is not used anymore in the clinical practice and that from a clinical viewpoint there is no evidence at present that there is a therapeutic need for this active substance in the treatment of cognitive and neurosensorial impairment in the elderly.
Danish: Gruppen understregede, at den ansøgte indikation ikke længere anvendes i klinisk praksis, og at der ud fra et klinisk synspunkt på nuværende tidspunkt ikke er beviser for et terapeutisk behov for dette aktive stof ved behandling af kognitiv og neurosensorisk funktionsnedsættelse hos ældre.
English: • The Committee considered the overall submitted data provided by the MAHs and the outcome of the scientific advisory group.
Danish: • Udvalget noterede sig de overordnede data indgivet af indehaverne af markedsføringstilladelsen samt den videnskabelige rådgivende gruppes resultater.
English: There are 2 further studies by Hugonot et al with population of 114-127 patients, both showing superiority over placebo.
Danish: Der findes yderligere 2 undersøgelser af Hugonot et al, der omfattede en population på 114-127 patienter, og som begge påviste overlegenhed i forhold til placebo.
English: Among these 3 studies, the publications by Lazzaroni et al and Aranda et al indicated superiority over placebo, while the study by Vellas et al demonstrated similar efficacy to placebo.
Danish: Blandt disse 3 undersøgelser blev der i publikationer fra Lazzaroni et al og Aranda et al påvist overlegenhed i forhold til placebo, mens undersøgelsen fra Vellas et al viste lignende virkning for placebo.
English: • The suspension of the marketing authorisation for dihydroergocristine containing medicinal products referred to in Annex I in the event that no other indications are approved as part of their marketing authorisation.
Danish: • suspendering af markedsføringstilladelsen for lægemidler, der indeholder dihydroergocristin, som omhandlet i bilag I, såfremt der i markedsføringstilladelsen ikke er godkendt andre indikationer.
English: In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the product outweigh the identified risk.
Danish: For at ophæve suspenderingen skal indehaverne af markedsføringstilladelsen identificere en specifik patientpopulation, hos hvem fordelene ved lægemidlet opvejer de fundne risici.
English: Following a national pharmacovigilance review held in 2011 new spontaneous notifications reported with some of those products identified serious cases of fibrosis and ergotism and France considered that this safety concern is not outweighed by the limited evidence of efficacy.
Danish: Efter en national gennemgang af lægemiddelovervågningen i 2011 blev der gennem nye spontane indberetninger om enkelte af disse lægemidler identificeret alvorlige tilfælde af fibrose og ergotisme, og Frankrig mente, at dette sikkerhedsproblem ikke opvejes af den begrænsede dokumentation for virkningen.
English: The marketing authorisation holders (MAHs) submitted all available efficacy data from clinical trials and observational studies, including data that became available since the granting of the initial marketing authorisation.
Danish: Indehaverne af markedsføringstilladelsen forelagde alle tilgængelige data om virkning fra kliniske undersøgelser og observationsstudier, herunder oplysninger offentliggjort siden udstedelsen af den oprindelige markedsføringstilladelse.
English: The most recent study (Vellas 1998 - Not published) that became available after the granting of the initial marketing autohrisation, uses a standardised definition of diagnosis (patients had to present a moderate memory deficit, with a Mini-Mental Sate Examination MMSE > 25 and a score total > 38 and < 70 on the Mac Nair and Kahn auto-questionnaire assessing the difficulties in daily activities) and defines the primary efficacy criterion a priori (the Mac Nair and Kahn auto-questionnaire and the Gröber and Buschke test).
Danish: Den seneste undersøgelse (Vellas 1998 - ikke offentliggjort), som blev gjort tilgængelig efter udstedelsen af den oprindelige markedsføringstilladelse, anvender en standarddefinition for diagnosen (patienterne skulle have et moderat hukommelsestab med en MMSE-score (Mini-Mental Sate Examination) > 25 og en totalscore > 38 og < 70 på Mac Nair og Kahns spørgeskema til selvvurdering af vanskeligheder ved daglige aktiviteter) og foruddefinerer det primære effektkriterium (Mac Nair og Kahns selvvurderingsspørgeskema samt Gröber og Buschkes test).
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations or suspension of the marketing authorisations, as applicable, taking into consideration the approved indications for each product
Danish: Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelserne eller for suspendering af markedsføringstilladelserne under hensyntagen til de godkendte indikationer for hvert lægemiddel
English: In addition it has a pharmacological action on the serotoninergic and dopaminergic receptors leading to interesting effects on cerebral metabolism.
Danish: Desuden har det en farmakologisk virkning på serotoninerge og dopaminerge receptorer, der medfører interessante virkninger på den cerebrale metabolisme.
English: • The Committee considered that a potential causal association between fibrotic reactions or ergotism and dihydroergocristine cannot be excluded.
Danish: • Udvalget vurderede, at der ikke kan udelukkes en mulig årsagssammenhæng mellem fibrotiske reaktioner eller ergotisme og dihydroergocristin.
English: This is indicative of a causal relationship between fibrosis and dihydroergocristine.
Danish: Dette tyder på en årsagssammenhæng mellem fibrose og dihydroergocristin.
English: Moreover the severity of such adverse effects, their possible fatal outcome and the raised risk for patient to develop a fibrotic disorder with long term use according to the authorised indications should be underlined.
Danish: Endvidere skal det understreges, at sådanne bivirkninger er alvorlige, kan være dødelige og kan øge risikoen for, at patienten udvikler en fibrotisk lidelse ved langvarig brug i henhold til de godkendte indikationer.
English: Overall, the varying affinity for serotoninergic receptors with the different ergot derivatives and the therapeutic doses used may explain the differences observed for notification rates for the fibrotic reactions.
Danish: Samlet set kan den varierende affinitet for serotonerge receptorer med forskellige ergotderivater og de anvendte terapeutiske doser forklare de forskelle, der er observeret i forbindelse med indberetningsfrekvensen for fibrotiske reaktioner.
English: While it is agreed that the medical terminology used nowdays and in the past differs and that the data needs to be assessed bearing this aspect in mind, the clinical symptom of dementia is a result of various pathophysiological processes which makes pooling and comparison of the data difficult, especially when the individual studies used slightly different inclusion criteria.
Danish: Selv om der er enighed om, at den medicinske terminologi, der anvendes i dag, adskiller sig fra tidligere anvendt terminologi, og at data skal vurderes med dette aspekt for øje, skyldes det kliniske symptom på demens forskellige patofysiologiske processer, der gør pooling og sammenligning af data vanskelig, især når de enkelte undersøgelser anvender forskellige inklusionskriterier.
English: − Is not favourable for acute retinopathies of vascular origin.
Danish: − ikke er fordelagtigt til akut retinopati af vaskulær oprindelse.
English: The MAHs also submitted their own overviews and critical summaries of all spontaneous reports of fibrotic reactions (cardiac with or without pulmonary arterial hypertension, pulmonary, pleural, peritoneal, retroperitoneal, etc) and ergotism with their ergot derivatives-containing medicinal products.
Danish: Indehaverne af markedsføringstilladelsen fremlagde desuden deres egne oversigter over og kritiske sammendrag af alle spontane indberetninger om fibrotiske reaktioner (kardielle med eller uden pulmonal arteriel hypertension, pulmonal, pleural, peritoneal, retroperitoneal osv.) og ergotisme sammen med deres lægemidler indeholdende ergotderivater.
English: The data from the reported cases of fibrosis (n=12) are indicative of the capacity of dihydroergocristine to induce fibrotic reactions, mostly localised in the pulmonary area considering also the improvement of some patients following discontinuation of the product.
Danish: Dataene fra de indberettede tilfælde af fibrose (n=12) er udtryk for dihydroergocristins evne til at forårsage fibrotiske reaktioner, hovedsageligt lokaliseret i det pulmonale område, også i betragtning af en forbedring hos enkelte patienter efter seponering af lægemidlet.
English: • The Committee considered that the benefit-risk balance of dihydroergocristine containing products:
Danish: • Udvalget vurderede, at benefit/risk-forholdet for lægemidler, der indeholder dihydroergocristin:
English: A scientific advisory group (SAG) was convened in December 2012 at the request of the CHMP during which the experts discussed, based on their clinical experience, whether this substance plays a role in the symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Danish: En videnskabelig rådgivende gruppe (SAG) blev efter anmodning fra CHMP indkaldt til møde i december 2012, hvor eksperterne på baggrund af deres kliniske erfaring drøftede, om dette stof spiller en rolle i symptomatisk behandling af kronisk patologisk kognitiv og neurosensorisk funktionsnedsættelse hos ældre (ekskl.
English: Dihydroergocristine is a partial agonist of α-adrenoreceptors that decreases the activity of sympathetic centres and is responsible for a peripheral adrenolytic effect with an increased venous wall tone.
Danish: Dihydroergocristin er en partiel agonist for α-adrenoreceptorer, der reducerer aktiviteten af sympatiske centre, og er ansvarlig for en perifer adrenolytisk effekt med en forøget venøs vægtonus.
English: Based on these data and based on the pharmacological plausibility, dihydroergocristine is considered to be associated with fibrotic reactions.
Danish: På grundlag af disse data og den farmakologiske sandsynlighed anses dihydroergocristin for at være tilknyttet fibrotiske reaktioner.