FrancophonIA/ELRC3.0 huggingface dataset:
English: Elderly patients may have increased trimetazidine exposure due to age-related decrease in renal function.
Danish: Ældre patienter kan i øget omfang være eksponeret for trimetazidin på grund af aldersbetinget, nedsat nyrefunktion.
English: • The Committee also considered the cumulative efficacy and safety data submitted for the indications of the prophylactic treatment of attacks of angina pectoris, ancillary symptomatic treatment of vertigo and tinnitus and ancillary treatment of visual acuity decrease and visual field disturbances due to vascular reasons.
Danish: • Udvalget overvejede også de indsendte, kumulative data om virkning og sikkerhed for indikationerne for profylaktisk behandling af angina pectoris, supplerende symptomatisk behandling af vertigo og tinnitus samt supplerende behandling af nedsat synsskarphed og synsfeltforstyrrelser af vaskulære årsager.
English: Therefore, trimetazidine as add-on therapy may represent an optional treatment drug to be used in association with first-line anti-anginal drugs especially in those patients for whom optimally control of symptoms cannot be achieved with other anti-anginal drugs in monotherapy due to haemodynamic intolerance or chronotropic incompetence.
Danish: Derfor kan trimetazidin som supplerende behandling vælges til anvendelse sammen med førstelinje, antianginøse lægemidler, især til patienter, for hvem optimal kontrol af symptomer ikke kan opnås med andre antianginøse lægemidler som monoterapi på grund af hæmodynamisk intolerance eller kronotrop inkompetence.
English: Therefore, the Committee concluded that the benefit-risk balance of trimetazidine- containing medicinal products in the add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies, remains positive under normal conditions of use, subject to the restrictions, warnings, changes to the product information, additional pharmacovigilance activities and risk minimisation measures agreed.
Danish: Udvalget konkluderede derfor, at benefit/risk-forholdet for lægemidler, der indeholder trimetazidin, som supplerende lægemiddel i den symptomatiske behandling af patienter med stabil angina pectoris, der ikke kan kontrolleres tilstrækkeligt med eller ikke kan tåle førstelinjebehandling med antianginøse midler, forbliver positivt under normale betingelser for anvendelse, forudsat at begrænsninger, advarsler og ændringer i produktoplysningerne, yderligere lægemiddelovervågningsaktivitet og foranstaltninger for risikominimering vedtages.
English: Considering all currently available data, the CHMP concluded that trimetazidine-containing medicinal products should be contraindicated in patients with severe renal impairment (creatinine clearance < 30ml/min).
Danish: Ved betragtning af alle aktuelt tilgængelige data konkluderede CHMP, at lægemidler, der indeholder trimetazidin, bør være kontraindiceret til patienter med svær nyreinsufficiens (creatininclearance < 30 ml/min).
English: Thus, all of these elements deriving from post-approval data do not demonstrate a relevant clinical benefit of trimetazidine for patients suffering from tinnitus, dizziness or hearing loss.
Danish: Følgelig kan ingen af disse elementer, som er afledt af data efter godkendelsen, påvise en relevant, klinisk fordel ved trimetazidin til patienter, der lider af tinnitus, svimmelhed eller høretab.
English: The Committee, therefore, concluded that the benefit-risk balance of trimetazidine- containing medicinal products remains positive under normal conditions of use, subject to the restrictions, warnings, changes to the product information, additional pharmacovigilance activities and risk minimisation measures agreed, only as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line anti-anginal therapies.
Danish: Udvalget konkluderede derfor, at benefit/risk-forholdet for lægemidler, der indeholder trimetazidin, forbliver positivt under normale betingelser for anvendelse, forudsat at begrænsninger, advarsler og ændringer i produktoplysningerne, yderligere lægemiddelovervågningsaktivitet og foranstaltninger for risikominimering vedtages, og alene som supplerende lægemiddel i den symptomatiske behandling af patienter med stabil angina pectoris, der ikke kan kontrolleres tilstrækkeligt med eller ikke kan tåle førstelinjebehandling med antianginøse midler.
English: In conclusion, the data submitted for trimetazidine with respect to ENT indications, insufficiently support the demonstration of a relevant clinical benefit for these patients suffering from tinnitus, vertigo or hearing loss symptomatology who were targeted by the ENT therapeutic indications as mentioned currently in the European marketing authorisations.
Danish: Konklusionen er, at de indsendte data vedrørende trimetazidin i forhold til øre-næse-halsindikationer ikke i tilstrækkelig grad understøtter påvisning af en relevant, klinisk fordel for de patienter, der led af symptomatologierne tinnitus, vertigo eller høretab, og som var målgruppen for de øre-næse-hals-indikationer, der for indeværende nævnes i de europæiske markedsføringstilladelser.
English: Trimetazidine-containing medicinal products are indicated for prophylactic treatment of angina pectoris crisis, ancillary symptomatic treatment of vertigo and tinnitus and ancillary treatment of visual acuity decrease and visual field disturbances due to vascular reasons.
Danish: Lægemidler, der indeholder trimetazidin, er indiceret til profylaktisk behandling af angina pectoris, supplerende symptomatisk behandling af vertigo og tinnitus samt supplerende behandling af nedsat synsskarphed og synsfeltforstyrrelser af vaskulære årsager.
English: • For the indications of symptomatic treatment of tinnitus, vertigo and of visual field disturbances, the CHMP concluded that in view of the newly available safety data and very limited efficacy, the benefits no longer outweigh the risks under normal conditions of use and therefore these therapeutic indications should be removed.
Danish: • For indikationerne for symptomatisk behandling af tinnitus, vertigo og synsfeltforstyrrelser har CHMP ud fra de nye, tilgængelige data om sikkerhed og meget begrænset virkning konkluderet, at fordelene ikke længere opvejer risiciene under normale betingelser for anvendelse, og at disse terapeutiske indikationer derfor bør slettes.
English: The CHMP also agreed on a study protocol to assess the effect of renal impairment and age on trimetazidine pharmacokinetics for the study to be conducted.
Danish: CHMP blev desuden enige om, at der i forbindelse med den undersøgelse, der skal udføres, er behov for en undersøgelsesprotokol til vurdering af indvirkningen af nyreinsufficiens og alder på trimetazidins farmakokinetik.
English: For the remaining two indications of symptomatic treatment of tinnitus, vertigo and of visual field disturbances, the CHMP concluded that in view of the newly available safety data and very limited efficacy, the benefits no longer outweigh the risks under normal conditions of use and therefore these therapeutic indications should be removed.
Danish: For så vidt angår de resterende to indikationer for symptomatisk behandling af tinnitus, vertigo og synsfeltforstyrrelser har CHMP ud fra de nye, tilgængelige data om sikkerhed og meget begrænset virkning konkluderet, at fordelene ikke længere opvejer risiciene under normale betingelser for anvendelse, og at disse terapeutiske indikationer derfor bør slettes.
English: Overall, the CHMP concluded that after assessing the newly available data, the benefits continue to outweigh the risks in patients with angina pectoris but that treatment should be restricted to add-on to existing treatments in patients who are not adequately controlled by or intolerant to other medicines for angina pectoris.
Danish: Efter at have vurderet de nye tilgængelige data fandt CHMP, at fordelene fortsat opvejer risiciene for patienter med angina pectoris, men at behandlingen bør begrænses til at være et supplement til eksisterende behandling af patienter, som ikke kan kontrolleres tilstrækkeligt med eller ikke kan tåle lægemidler mod angina pectoris.
English: • Considering all the currently available safety data the Committee concluded that trimetazidine should be contraindicated in patients with Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders as well as in patients with severe renal impairment (creatinine clearance < 30ml/min).
Danish: • Ved betragtning af alle aktuelt tilgængelige sikkerhedsdata konkluderede udvalget, at trimetazidin bør være kontraindiceret til patienter med Parkinsons sygdom, parkinsonsymptomer, tremor, »Restless Legs Syndrome« og andre beslægtede bevægelsesforstyrrelser samt til patienter med svært nedsat nyrefunktion (creatinineclearance < 30ml/min).
English: A PASS study to address all important, potential and identified risks, particularly Parkinsonism, and a Drug utilization study to monitor whether the risk minimization measures put in place as results of the referral procedure are effective have been requested by the CHMP.
Danish: CHMP har anmodet om, at der udføres et PASS-undersøgelse (»Post Authorisation Safety Study«) med henblik på at håndtere alle vigtige, potentielle og identificerede risici, især parkinsonisme, og en undersøgelse af lægemiddelanvendelse til kontrol af, hvorvidt de fastsatte foranstaltninger for risikominimering, som er et resultat af proceduren for indbringelse af sager, er effektive.
English: Considering all currently available data, the CHMP concluded that trimetazidine-containing medicines should be contraindicated in patients with Parkinson disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders.
Danish: Ved betragtning af alle aktuelt tilgængelige data konkluderede CHMP, at lægemidler, der indeholder trimetazidin, bør være kontraindiceret til patienter med Parkinsons sygdom, parkinsonsymptomer, tremor, »Restless Legs Syndrome« (RLS) og andre relaterede bevægelsesforstyrrelser.
English: This analysis showed that in patients with chronic stable angina trimetazidine given as add-on to atenolol significantly improved exercise tolerance (p<0.01), time to 1 mm ST segment depression and time to angina.
Danish: Denne analyse viste, at hos patienter med kronisk, stabil angina forbedrede trimetazidin, givet som supplement til atenolol,
English: was added to 50 mg atenolol (o.d.) for 8 weeks and produced a significant increase (+34.4s, p=0.03) in the time to 1-mm ST-segment depression in exercise tests, in a sub-group of patients (n=173), when compared to placebo, 12 hours after taking the drug.
Danish: 223 patienter blev randomiseret til denne dobbeltblinde, placebokontrollerede undersøgelse, hvor én 35 mg trimetazidin depottablet (to gange dagligt) blev tilsat 50 mg atenolol (en gang dagligt) i 8 uger og frembragte en signifikant stigning (+34,4 s, p=0,03) i tid til 1-mm ST-segment-depression ved belastnings-EKG hos en undergruppe patienter (n=173), sammenlignet med placebo, 12 timer efter indtagelse af lægemidlet.
English: Furthermore, the multiplicity of comparisons was not taken into account in the statistical analyses and the criteria were not presented hierarchically, so this comparison cannot have any demonstrative value; and lastly, the Perdriel single dose electroretinographic study (versus pyridoxilate) used an injectable intravenous form of trimetazidine 20 mg that has not been authorised.
Danish: Derudover blev der ikke taget hensyn til den store mængde af sammenligninger i de statistiske analyser, og kriterierne var ikke fremlagt i hierarkisk orden, hvorfor sammenligningen ingen overbevisende værdi havde.
English: Among these nine studies, three were non-comparative studies (Guillaumat, 1982; Millara, 1988; Nowak, 2007); three were comparative studies of short duration (up to 3 months) conducted against products used at the time of these studies e.g. cinnarizine, piridoxilate which are no more considered as therapies of choice to treat or prevent retinal or glaucoma diseases by the ophthalmologists; two studies were conducted against placebo (Couderc, 1984 and Aron-Rosa, 1988).
Danish: Tre var komparative undersøgelser af kort varighed (op til 3 måneder) udført i forhold til de produkter, der blev anvendt på tidspunktet for undersøgelserne, f.eks. cinnarizin, piridoxilat, som af øjenlæger ikke længere betragtes som behandling eller profylakse af nethindesygdomme eller glaukom.
English: Whereas
Danish: og
English: In this study, the incidence of inhibitor development ranged from 28.2% to 37.7% for all FVIII products.
Danish: I denne undersøgelse var forekomsten af inhibitordannelse mellem 28,2 % og 37,7 % for alle FVIIIlægemidler.
English: - the RODIN (Research of Determinants of Inhibitor development)/PedNet registry; and
Danish: - RODIN-registeret (Research of Determinants of Inhibitor development)/PedNet registry,
English: Overall summary of the scientific evaluation of Kogenate Bayer and Helixate NexGen (see Annex A)
Danish: Samlet resumé af den videnskabelige vurdering af Kogenate Bayer og Helixate NexGen (se bilag A)
English: The PRAC noted that the Factor VIII gene mutation profile of these study population (in studies 200021EU and 100074US) reflects the typical distribution seen in patients with severe haemophilia A, indicating that there was no bias in patient recruitment.
Danish: PRAC bemærkede, at faktor VIIIgenmutationsprofilen for patientpopulationen i disse undersøgelser (200021EU og 100074US) afspejler den typiske fordeling hos patienter med svær hæmofili A som tegn på, at der ikke var skævhed i patientrekrutteringen.
English: Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP, having considered the PRAC recommendation dated 5 December 2013, is of the opinion that the marketing authorisations for Kogenate Bayer and Helixate NexGen should be varied as recommended by the PRAC (see Annex A).
Danish: I henhold til bestemmelserne i artikel 20 i forordning (EF) nr. 726/2004 og efter gennemgang af PRAC's anbefaling af 5. december 2013 er CHMP af den opfattelse, at markedsføringstilladelserne for Kogenate Bayer og Helixate NexGen bør ændres som anbefalet af PRAC (se bilag A).
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Kogenate Bayer and Helixate NexGen (see annexes A).
Danish: • PRAC behandlede proceduren i henhold til artikel 20 i forordning (EF) nr. 726/2004, for Kogenate Bayer og Helixate NexGen, (se bilag A),
English: In view of the above, the PRAC agreed that the current evidence does not confirm an increased risk of developing antibodies against Kogenate Bayer and Helixate NexGen when compared with other factor VIII products in PUPs with the bleeding disorder haemophilia A. However the PRAC considered that the frequency for inhibitor development in PUPs should be amended from “common” to “very common” in the section 4.8 of the SmPC and also recommended that the product information should be updated with results from the RODIN study as part of the routine risk minimisation activities.
Danish: På ovenstående baggrund fandt PRAC, at den nuværende evidens ikke bekræfter en højere risiko for dannelse af antistoffer mod Kogenate Bayer og Helixate NexGen end mod andre faktor VIIIlægemidler hos ikke tidligere behandlede patienter med blødningsforstyrrelsen hæmofili A. PRAC fandt imidlertid at angivelsen af hyppigheden af inhibitordannelse hos ikke tidligere behandlede patienter i afsnit 4.8 i produktresuméet burde ændres fra “almindelig” til “meget almindelig”, og anbefalede, at produktoplysningerne endvidere ajourføres med resultater fra RODIN-undersøgelsen som led i de rutinemæssige risikominimeringsaktiviteter.
English: The MAH will continue to support the RODIN/PedNet registry as well as the EUHASS registry, as per current obligations defined in the RMP, to further investigate individual risk factors for inhibitor development and risk mitigation in PUPs.
Danish: Indehaveren af markedsføringstilladelsen skal fortsat støtte RODIN/PedNet-registeret samt EUHASS-registeret i overensstemmelse med de gældende forpligtelser i risikostyringsplanen med henblik på yderligere undersøgelse af de enkelte risikofaktorer for inhibitordannelse samt risikonedsættelse hos ikke tidligere behandlede patienter.
English: The MAH also submitted data from four interventional clinical trials and six observational studies, which investigated the safety and efficacy of Kogenate Bayer/Helixate NexGen in haemophilia A patients, including studies 200021EU and 100074US in PUPs and minimally treated patients (MTPs).
Danish: Kogenate Bayer og Helixate NexGen hos patienter med hæmofili A, herunder undersøgelse 200021EU og 100074US hos tidligere ubehandlede patienter og minimalt behandlede patienter.
English: The reference Member State (RMS) is the United Kingdom and 12 concerned Member States (CMS) are involved: Austria, Czech Republic, Estonia, Finland, France, Germany, Greece, Italy, Latvia, the Netherlands, Slovakia and Spain.
Danish: Referencemedlemsstaten er Det Forenede Kongerige, og der er 12 berørte medlemsstater: Østrig, Tjekkiet, Estland, Finland, Frankrig, Tyskland, Grækenland, Italien, Letland, Nederlandene, Slovakiet og Spanien.
English: The opinion was converted into a Decision by the European Commission on 12 August 2013.
Danish: Udtalelsen blev omarbejdet til en afgørelse af Europa-Kommissionen den 12. august 2013.
English: International non-proprietary name (INN): doxycycline hyclate
Danish: Internationalt fællesnavn (INN): doxycyclinhyclat
English: During its meeting of 9-11 April 2013 the CVMP appointed Prof. C. Friis as the rapporteur and Dr M. Holzhauser-Alberti as the co-rapporteur for the re-examination procedure.
Danish: På sit møde den 9.-11. april 2013 udpegede CVMP prof. C. Friis som rapportør og Dr M. Holzhauser-Alberti som medrapportør for den fornyede overvejelsesprocedure.
English: The detailed grounds for the re-examination request were submitted by Eurovet Animal Health BV on 26 April 2013.
Danish: Den detaljerede begrundelse for anmodningen om fornyet overvejelse blev indgivet af Eurovet Animal Health BV den 26. april 2013.
English: Day 60 of the CMD(v) procedure was on 18 October 2012, and since the Member States concerned failed to reach an agreement, the procedure was referred to the CVMP.
Danish: Dag 60 af proceduren i CMD(v) var den 18. oktober 2012, og da de berørte medlemsstater ikke var i stand til at nå til enighed, blev proceduren indbragt for CVMP.
English: The re-examination procedure started on 27 April 2013.
Danish: Den fornyede overvejelsesprocedure blev indledt den 27. april 2013.
English: The referral procedure started on 7 November 2012.
Danish: Henvisningsproceduren blev indledt den 7. november 2012.
English: Written explanations were provided by the marketing authorisation holder on 8 January 2013.
Danish: Indehaveren af markedsføringstilladelsen indsendte skriftlige redegørelser den 8. januar 2013.
English: The Committee appointed Mr J. Schefferlie as rapporteur and Ms H. Jukes as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis G. J. Schefferlie og H. Jukes.
English: It is indicated in chickens to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by Ornithobacterium rhinotracheale (ORT).
Danish: Det er indiceret til kyllinger til nedsættelse af mortalitet, morbiditet, kliniske symptomer og læsioner ved pasteurellose forårsaget af Pasteurella multocida samt reduktion af morbiditet og læsioner ved luftvejsinfektioner forårsaget af Ornithobacterium rhinotracheale (ORT).
English: On 22 March 2013, Eurovet Animal Health BV notified the Agency of their intention to request a reexamination of the CVMP opinion of 7 March 2013.
Danish: Den 22. marts 2013 underrettede, Eurovet Animal BV agenturet om, at virksomheden havde til hensigt at anmode om fornyet overvejelse af CVMP's udtalelse af 7. marts 2013.
English: On 30 October 2012, the reference Member State, the United Kingdom, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 13(2) of Commission Regulation (EC) No. 1234/2008.
Danish: Den 30. oktober 2012 underrettede referencemedlemsstaten, Det Forenede Kongerige, Det Europæiske Lægemiddelagentur om, at CMD(v) ikke havde været i stand til at nå til enighed, og indbragte sagen for CVMP i medfør af 13, stk. 2, i Kommissionens forordning (EF) nr. 1234/2008.
English: Potential serious risks were identified during the decentralised procedure by the Netherlands regarding the appropriate withdrawal period for chicken meat and offal.
Danish: decentrale procedure påpegede Nederlandene en potentiel alvorlig risiko for menneskers sundhed vedrørende den korrekte tilbageholdelsestid for kød og indmad fra kyllinger.
English: On day 90, these issues remained unsolved and therefore a referral under Article 13(1) of Commission Regulation (EC) No. 1234/2008 to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 20 August 2012.
Danish: På dag 90 var disse spørgsmål fortsat uafklarede, hvorfor sagen den 20. august 2012 i medfør af artikel 13, stk. 1, i Kommissionens forordning (EF) nr. 1234/2008/EF blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentrale godkendelsesprocedurerveterinær (CMD(v)).
English: There are two authorised dosages: 10 mg/kg bw for 4 consecutive days, for which the withdrawal period is 3 days, and 20 mg/kg bw for 4 consecutive days for which the withdrawal period is 12 days.
Danish: Der er to godkendte doseringer: 10 mg/kg kropsvægt i 4 på hinanden følgende dage, ved hvilken tilbageholdelsestiden er 3 dage, og 20 mg/kg kropsvægt i 4 på hinanden følgende dage, ved hvilken tilbageholdelsestiden er 12 dage.
English: The CVMP concluded a withdrawal period of 9 days is appropriate for chickens for the dose of 20 mg/kg bw for 4 consecutive days.
Danish: CVMP konkluderede, at en tilbageholdelsestid på 9 dage er passende for kyllinger ved en dosering på 20 mg/kg kropsvægt i 4 på hinanden følgende dage.
English: Soludox 500 mg/g powder for use in drinking water for pigs and chickens contains doxycycline hyclate as active ingredient.
Danish: Soludox, pulver til opløsning i drikkevand, 500 mg/g, til svin og kyllinger, indeholder doxycyclinhyclat som aktivt indholdsstof.
English: Opinion following an Article 130F referral for Soludox 500 mg/g powder for use in drinking water for pigs and chickens and associated names EMA/426302/2013
Danish: Udtalelse efter en artikel 130F-henvisning for Soludox, pulver til opløsning i drikkevand, 500 mg/g, til svin og kyllinger, og relaterede navne EMA/426302/2013
English: The worksharing procedure (UK/V/xxxx/WS/006) involving Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/WS/002) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/WS/002) started on 6 January 2012.
Danish: Arbejdsdelingsproceduren (UK/V/xxxx/WS/006) for Soludox, pulver til opløsning i drikkevand, 500 mg/g, til svin og kyllinger (NL/V/0141/001/WS/002) og Soludox, pulver til opløsning i drikkevand, 500 mg/g, til svin og kyllinger (UK/V/0349/001/WS/002) blev indledt den 6. januar 2012.