FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel DURA to Mylan dura GmbH on 21 September 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel DURA til Mylan dura GmbH den 21. september 2009.
English: The standard dose of Clopidogrel DURA is one 75 mg tablet once a day, taken with or without food.
Danish: Standarddosis af Clopidogrel DURA er en 75 mg tablet en gang dagligt med eller uden et måltid.
English: What are the benefit and risk of Clopidogrel DURA?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel DURA?
English: The full EPAR for Clopidogrel DURA can be found here.
Danish: Den fuldstændige EPAR for Clopidogrel DURA findes her.
English: This means that Clopidogrel DURA is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel DURA er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union, og som hedder Plavix.
English: Clopidogrel DURA is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel DURA anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: The Committee recommended that Clopidogrel DURA be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel DURA.
English: Clopidogrel DURA can be started between a few days and 35 days after the attack;
Danish: Behandling med Clopidogrel DURA kan påbegyndes få dage efter anfaldet og indtil 35 dage efter,
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel DURA has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel DURA i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: Clopidogrel DURA is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel DURA er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: For more information on generic medicines, see the question-and-answer document here.
Danish: Der kan indhentes yderligere oplysninger om generiske lægemidler i dokumentet med spørgsmål og svar
English: Because Clopidogrel DURA 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 DURA er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Why has Clopidogrel DURA been approved?
Danish: Hvorfor blev Clopidogrel DURA godkendt?
English: Clopidogrel DURA can be given to the following groups of patients:
Danish: Clopidogrel DURA kan gives til følgende
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CHMP's anbefalinger, kan du læse den faglige
English: Because Clopidogrel DURA is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel DURA er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: Clopidogrel DURA is a ‘generic medicine'.
Danish: Det fås som lyserøde Clopidogrel DURA er et ‘generisk lægemiddel'.
English: The active substance in Clopidogrel DURA, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel DURA, clopidogrel, er en trombocytfunktionshæmmer.
English: How has Clopidogrel DURA been studied?
Danish: Hvordan blev Clopidogrel DURA undersøgt?
English: Clopidogrel DURA can be started between seven days and six months after the
Danish: Behandling med Clopidogrel DURA kan påbegyndes 7 dage
English: 1 bottle
Danish: 1 flasker
English: 40 mg/ml Oral solution bottle (glass)
Danish: 40 mg/ml oral opløsning
English: The reasons being the following:
Danish: Følgende begrundelser anførtes:
English: BACKGROUND INFORMATION (2)
Danish: BAGGRUNDSOPLYSNINGER (2)
English: The withdrawal period for milk was 2.5 days.
Danish: Tilbageholdelsesperioden for mælk var 2,5 dage.
English: The product was accepted by the Czech Republic, Italy and Spain.
Danish: Produktet godkendtes af Den Tjekkiske Republik, Italien og Spanien.
English: The final opinion was converted into a Decision by the European Commission on 5 September 2008.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 5. september 2008.
English: Concerns were raised by Belgium, Germany and the United Kingdom regarding the inadequacy of the withdrawal periods and the applications were withdrawn from these countries.
Danish: Belgien, Tyskland og Det Forenede Kongerige gav udtryk for deres betænkelighed over de utilstrækkelige tilbageholdelsestider, og ansøgningerne blev tilbagekaldt fra disse stater.
English: The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain and the United Kingdom.
Danish: Referencemedlemsstaten var Frankrig, og de berørte medlemsstater var Belgien, Den Tjekkiske Republik, Tyskland, Italien, Spanien og Det Forenede Kongerige.
English: Belgium referred the issue to the EMEA on 28 July 2005.
Danish: Belgien fremsendte sagen til EMEA den 28. juli 2005.
English: On 25 October 2006 the European Commission forwarded a draft decision to the Standing Committee on Veterinary Medicinal Products for adoption by written procedure.
Danish: Den 25. oktober 2006 fremsendte Europa-Kommissionen et udkast til afgørelse til Det Stående Udvalg for Veterinærlægemidler med henblik på vedtagelse ved skriftlig procedure.
English: The arbitration procedure started on 8 September 2005 with the adoption of a list of questions.
Danish: Voldgiftsproceduren indledtes den 8. september 2005 med vedtagelsen af en liste med spørgsmål.
English: The procedure for evaluation of the new data started on 15 April 2008.
Danish: Proceduren for vurdering af de nye data indledtes den 15. april 2008.
English: • it was not possible to establish a withdrawal period for cattle and pigs based on the data available;
Danish: • Det var ikke muligt at fastsætte en tilbageholdelsesperiode for kvæg og svin på grundlag af de foreliggende oplysninger
English: The product is used in the treatment of respiratory infections caused by Pasteurella multocida and Mannheimia haemolytica in cattle and for the treatment of respiratory infections due to Pasteurella multocida in pigs.
Danish: Lægemidlet anvendes til behandling af luftvejsinfektioner forårsaget af Pasteurella multocida og Mannheimia haemolytica hos kvæg og til behandling af luftvejsinfektioner forårsaget af Pasteurella multocida hos svin.
English: The reasons for the suspension were the same as those identified in the May 2006 CVMP meeting.
Danish: Begrundelserne for suspenderingen var identiske med de begrundelser, som var blevet identificeret på CVMP's møde i maj 2006.
English: A mutual recognition procedure was started on 28 April 2005.
Danish: En gensidig anerkendelsesprocedure indledtes den 28. april 2005.
English: The detailed grounds for the request were submitted to the EMEA on 18 July 2006 and the evaluation procedure for the re-examination started on 19 July 2006.
Danish: De nærmere begrundelser for anmodningen fremlagdes for EMEA den 18. juli 2006, og evalueringsproceduren for revurderingen indledtes den 19. juli 2006.
English: • the currently authorised withdrawal periods are inadequate to ensure that foodstuffs obtained from treated animals do not contain residues which might constitute a health hazard to the consumer.
Danish: • De godkendte tilbageholdelsesperioder er for korte til at sikre, at levnedsmidler hidrørende fra de behandlede dyr ikke indeholder restkoncentrationer, som kan være sundhedsfarlige for forbrugeren.
English: During the written procedure a request was received from France for a scientific assessment of new studies made available by the Marketing Authorisation Holder.
Danish: I løbet af den skriftlige procedure modtog udvalget en anmodning fra Frankrig om gennemførelse af en faglig vurdering af nye undersøgelser, som indehaveren af markedsføringstilladelsen havde fremlagt.
English: The rapporteur was Mrs. R. Kearsley and the co-rapporteur was Prof. C. Friis.
Danish: Rapportøren var R. Kearsley, og medrapportøren var prof. C. Friis.
English: • the currently established withdrawal periods for cattle and pigs are inadequate to ensure that residues do not exceed the MRLs;
Danish: • De aktuelt fastsatte tilbageholdelsesperioder for kvæg og svin er utilstrækkelige til at sikre, at restkoncentrationerne ikke overstiger MRL-værdierne
English: During its June 2006 meeting, the CVMP appointed Dr. R. Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Danish: På udvalgets møde i juni 2006 udpegede CVMP dr. R. Breathnach som rapportør for vurderingen af begrundelserne for anmodningen om revurdering af udtalelsen.
English: Furthermore, the Committee recommends varying the marketing authorisations of the veterinary medicinal products referred to in Annex I in accordance with the Summary of Product Characteristics (SPC) as set out in Annex III.
Danish: Udvalget anbefaler endvidere at variere markedsføringstilladelserne for de veterinærlægemidler, der er nævnt i bilag I, i overensstemmelse med produktresuméet (SPC) i bilag III.
English: Therefore, the Committee adopted by consensus an opinion recommending the lifting of the suspension of the marketing authorisations for the above-mentioned product.
Danish: Derfor vedtog udvalget med enstemmighed en udtalelse, hvori det anbefaledes at ophæve suspenderingen af markedsføringstilladelserne for ovennævnte lægemiddel.
English: The rapporteur was Mr. J. Schefferlie and the co-rapporteur was Prof. R. Kroker.
Danish: J. Schefferlie var rapportør og prof. R. Kroker medrapportør.
English: Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic belonging to the penicillin group.
Danish: Suramox 15 % LA er en suspension til injektion, som indeholder amoxicillin, der er et beta-lactam antibiotikum tilhørende penicillingruppen.
English: In both species the product is administered intramuscularly at a dose of 15 mg amoxicillin/kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice with a 48 hour interval between doses.
Danish: For begge dyrearters vedkommende gives produktet intramuskulært i en dosis på 15 mg amoxicillin pr. kg legemsvægt (svarende til 1 ml Suramox 15 % LA pr. 10 kg legemsvægt) to gange med 48 timers mellemrum mellem doserne.
English: The scope of the referral was to agree whether the proposed withdrawal periods of 58 days for cattle and 35 days for pigs were adequately established.
Danish: Formålet med indbringelsen var at fastslå, hvorvidt de foreslåede tilbageholdelsesperioder på 58 dage for kvæg og 35 dage for svin var fastsat med tilstrækkelig sikkerhed.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the SPC in Annex III.
Danish: Listen over de berørte lægemiddelnavne findes i bilag I. De faglige konklusioner findes i bilag II og produktresuméet i bilag III.
English: On 14 November 2006 the European Commission suspended the written procedure and on 16 November 2006, requested the CVMP to consider the new residue studies in the assessment of the referral and to revise as appropriate the opinion of 13 September 2006.
Danish: Den 14. november 2006 suspenderede Europa-Kommissionen den skriftlige procedure og anmodede den 16. november 2006 CVPM om at behandle de nye restkoncentrationsundersøgelser i vurderingen af indbringelsen og i givet fald at revidere udtalelsen af 13. september 2006.
English: The Marketing Authorisation Holder submitted further new residue studies to the CVMP on 14 April 2008.
Danish: Indehaveren af markedsføringstilladelsen fremlagde resultaterne af nye restkoncentrationsundersøgelser den 14. april 2008 for CVMP.
English: On 1 June 2006, the MAH notified the EMEA of its intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2.
Danish: Den 1. juni 2006 meddelte indehaveren af markedsføringstilladelsen EMEA, at han havde til hensigt at anmode om en revurdering af CVMP's udtalelse i overensstemmelse med artikel 36, stk. 42.
English: On 13 June 2007 the European Commission adopted a Commission Decision suspending the national marketing authorisations for Suramox 15% LA and Stabox 15% LA, but providing an opportunity for the decision to be reviewed further to a new opinion formulated by the CVMP on the basis of the assessment of new residue depletion studies.
Danish: Den 13. juni 2007 vedtog Europa-Kommissionen en kommissionsafgørelse om suspendering af de nationale markedsføringstilladelser for Suramox 15 % LA og Stabox 15 % LA, men gav dog mulighed for at afgørelsen kunne revideres efter en ny udtalelse fra CVMP på grundlag af en vurdering af nye restkoncentrationsundersøgelser.
English: On 13 September 2006 the CVMP considered the detailed grounds for the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended.
Danish: Den 13. september 2006 behandlede CVMP de nærmere begrundelser for revurderingen af udtalelsen og bekræftede sin tidligere udtalelse med den konklusion at markedsføringstilladelsen for Suramox 15 % LA skulle suspenderes.
English: The Marketing Authorisation Holder (MAH) subsequently provided written explanations to the Committee on 16 January 2006.
Danish: Efterfølgende fremlagde indehaveren af markedsføringstilladelsen den 16. januar 2006 en skriftlig redegørelse for udvalget.
English: The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007.
Danish: Den 9. januar 2007 fremlagde indehaveren af markedsføringstilladelsen de nye restkoncentrationsundersøgelser for CVMP og afgav den 13. marts 2007 flere mundtlige redegørelser for udvalget.
English: FOLLOW-UP OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Suramox 15 % LA and its associated name Stabox 15 % LA International Non-Proprietary Name (INN): Amoxicillin
Danish: Suramox 15 % LA og tilknyttede navn Stabox 15 % LA Internationalt fællesnavn (INN): Amoxicillin
English: On 14 March 2007 the CVMP, having considered the new residue studies, concluded that it was not possible to set a withdrawal period for Suramox 15% LA and Stabox 15% LA, for either cattle or pig meat and offal and therefore recommended by consensus the suspension of the above marketing authorisations for the above-mentioned products.
Danish: På sit møde den 14. marts 2007 behandlede CVMP de nye restkoncentrationsundersøgelser og konkluderede, at det ikke var muligt at fastsætte en tilbageholdelsesperiode for Suramox 15 % LA og Stabox 15 % LA for hverken kød eller indvolde fra kvæg og svin, anbefalede derfor med enighed, at ovennævnte markedsføringstilladelser for de nævnte lægemidler suspenderes.
English: During its June 2008 meeting the CVMP considered the new residue studies submitted with regard to Suramox 15% LA and concluded that withdrawal periods can now be set for both cattle and pigs for Suramox 15% LA and Stabox 15% LA.
Danish: På sit møde i 2008 behandlede CVMP resultaterne af de nye restkoncentrationsundersøgelser, som var fremlagt for Suramox 15 % LA, og konkluderede, at der nu kunne fastsættes tilbageholdelsestider for såvel kvæg som svin for Suramox 15 % LA og Stabox 15 % LA.
English: During its May 2006 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion recommending the suspension of the marketing authorisations for Suramox 15% LA and the Stabox 15% LA, for cattle and pigs.
Danish: På baggrund af de samlede fremlagte oplysninger og den faglige debat i udvalget vedtog CVPM på sit møde i maj 2006 enstemmigt en udtalelse med henstilling om at suspendere markedsføringstilladelserne for Suramox 15 % LA og Stabox 15 % LA til kvæg og svin.
English: A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S.A. in France on 6 July 2004 based on an abridged application citing Duphamox LA as reference medicinal product.
Danish: Der er tidligere, nemlig den 6. juli 2004, blevet udstedt en markedsføringstilladelse for Suramox 15 % LA til Virbac S.A. i Frankrig på grundlag af en forkortet ansøgning med Duphamox LA som referencelægemiddel med tilbageholdelsesperioder for Suramox 15 % på 58 dage for kvæg til kød og indvolde og 35 dage for svin til kød og indvolde.
English: Some cases have had fatal outcome.
Danish: Nogle tilfælde har haft fatalt udfald.
English: However, the occurrence was rare.
Danish: Imidlertid, var forekomsten sjælden.
English: There were three groups in this study.
Danish: Der var tre grupper i dette forsøg.
English: Patient's Name: _____________________ Doctor's Name: _____________________ Doctor's Phone: _____________________
Danish: Patientens navn: _____________________ Lægens navn: _____________________ Lægens telefonnr.
English: There is no experience in children.
Danish: Der er ingen erfaring med børn.
English: (95% confidence interval)
Danish: (95% konfidensinterval)
English: The marketing authorisation holder should submit 6 monthly periodic safety update reports.
Danish: Indehaveren af markedsføringstilladelsen skal indsende periodic safety updates reports hver 6. måned.
English: • protein in urine.
Danish: • protein i urinen.
English: Some patients were treated for up to 60 months duration.
Danish: Nogle patienter blev behandlet i op til 60 måneder.
English: • You should be screened for tuberculosis.
Danish: • De bør screenes for tuberkulose.
English: Because the elimination of adalimumab may take up to five months, monitoring should be continued throughout this period.
Danish: Da udskillelsen af adalimumab kan vare op til fem måneder, bør monitoreringen fortsættes i hele denne periode.
English: Infections may progress more rapidly and be more severe.
Danish: Infektioner kan udvikle sig hurtigere og kan være mere alvorlige.
English: Your doctor may decide to stop treatment.
Danish: Deres læge kan eventuelt beslutte at afbryde behandlingen.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable.
Danish: VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET Ikke relevant.
English: It should be noted that in the majority of those reports, tuberculosis was extra-pulmonary, i.e. disseminated.
Danish: Det bør bemærkes, at i størstedelen af disse rapporter var tuberkulose ekstra-pulmonær, med andre ord dissemineret.
English: 1 st injection: _______________________ Following injections:
Danish: Første injektion: _______________________ Efterfølgende injektioner:
English: If you use more Trudexa than you should:
Danish: Hvis De anvender mere Trudexa, end De bør:
English: Like all medicines, Trudexa can have side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Trudexa have bivirkninger, selv om alle ikke får dem.
English: An updated risk management plan should be provided as per the CHMP guideline on the risk management systems for medicinal products for human use.
Danish: En opdateret risk management-plan skal tilvejebringes ifølge CHMP guideline om risk managementsystemer for lægemidler til human anvendelse.
English: Improvement in quality of life was measured up to week 156 (36 months) and improvement was maintained through that time.
Danish: Forbedring af livskvalitet blev målt op til uge 156 (36 måneder) og forbedringen blev opretholdt gennem hele denne tidsperiode.
English: Other opportunistic infections:
Danish: Andre opportunistiske infektioner:
English: The primary non-responders were excluded from the studies and therefore these patients were not further evaluated.
Danish: De oprindelige non-responders blev ekskluderet fra forsøgene, og derfor blev disse patienter ikke yderligere undersøgt.
English: For all of the above indications, available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Danish: For alle ovenstående indikationer tyder tilgængelige data på, at det kliniske respons sædvanligvis opnås inden for 12 ugers behandling.
English: This includes tuberculosis.
Danish: Dette gælder også for tuberkulose.
English: Maintenance of clinical remission was evaluated in CHARM.
Danish: Vedligeholdelse af klinisk remission blev undersøgt i CHARM.
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Danish: DATO FOR ÆNDRING AF TEKSTEN { MM/ÅÅÅÅ }
English: BATCH NUMBER LOT:
Danish: BATCHNUMMER LOT:
English: The injection is complete when the yellow indicator stops moving.
Danish: Injektionen er færdig, når den gule indikator ikke bevæger sig mere.
English: In Study III, these improvements were maintained throughout 52 weeks.
Danish: I forsøg III holdt disse forbedringer sig i 52 uger.
English: If you take Trudexa your risk may increase.
Danish: Hvis De tager Trudexa, er Deres risiko forøget.
English: Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
Danish: Forsøg ikke at injicere Dem selv, før De er sikker på, hvordan De skal forberede og give injektionen.
English: − This medicine has been prescribed for you.
Danish: - Dette lægemiddel er ordineret til Dem personligt.
English: Change the place that you inject each time so that you do not become sore in one area.
Danish: Skift stedet, hvor De injicerer hver gang, så De ikke bliver øm i området.
English: WHAT TRUDEXA IS AND WHAT IT IS USED FOR
Danish: HVAD TRUDEXA ER, OG HVAD DET ANVENDES TIL
English: Serious infections:
Danish: Alvorlige infektioner:
English: Significant response was first observed at Week 2 and maintained through 24 weeks (Table 8).
Danish: Første signifikante respons blev observeret ved uge 2 og blev opretholdt frem til uge 24 (Tabel 8).
English: Do not use the product if the date has passed the month and year shown.
Danish: Anvend ikke produktet, hvis datoen har passeret den viste måned og år.
English: Study III also had a primary endpoint of changes in quality of life.
Danish: Forsøg III havde også et primært end-point, som var ændringer i livskvalitet.
English: Tuberculosis:
Danish: Tuberkulose:
English: Trudexa increases the risk of getting infections.
Danish: Trudexa øger risikoen for infektioner.
English: Puerto Rico 00617
Danish: Puerto Rico 00617 USA
English: The active substance is adalimumab.
Danish: Det aktive stof er adalimumab.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 1 September 2003
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN 1 September 2003
English: Among those, 66 patients showed no progression of structural damage defined by a change in the TSS of zero or less.
Danish: Blandt disse viste 66 patienter ingen af progression af strukturel ødelæggelse defineret som ændring af TSS på nul eller mindre.
English: What should I do before I give myself a subcutaneous injection of Trudexa?
Danish: Hvad skal jeg gøre, inden jeg giver mig selv subkutan injektion med Trudexa?
English: Monoclonal antibodies are proteins that recognise and bind to other unique proteins.
Danish: Monoklonale antistoffer er proteiner, som genkender andre unikke proteiner og bindes til disse.
English: Side effects may occur at least up to 5 months after the last treatment.
Danish: Bivirkninger kan forekomme op til 5 måneder efter den sidste behandling.
English: Do NOT remove the grey stopper or aluminium ring around the top of the vial.
Danish: Fjern IKKE den grå prop eller aluminiumringen rundt om hætteglassets top.
English: Hepatitis B Reactivation
Danish: Hepatitis B-reaktivering