FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of omega-3 fatty acids in the claimed indication has also not been demonstrated by other relevant RCTs conducted in other CV risk populations (e.g. coronary revascularisation, angina pectoris, ischaemic stroke ), including ORIGIN, SU.FOL.OM3, ASCEND, and VITAL.
Danish: Effekten ved omega-3-fedtsyrer i den ansøgte indikation er heller ikke blevet påvist i andre relevante randomiserede kontrollerede studier hos andre populationer med kardiovaskulær risiko (f.eks. koronar revaskularisering, angina pectoris, iskæmisk slagtilfælde), herunder ORIGIN, SU.FOL.OM3, ASCEND og VITAL.
English: However, with respect to statin therapy, CHMP concluded that subjects in this subgroup analysis were not on optimal statin therapy.
Danish: Hvad angår statin-behandling, vurderer CHMP imidlertid, at forsøgspersonerne i denne delgruppeanalyse ikke fik optimal statin-behandling.
English: The MAHs disagreed with the CHMP that the evidence that supported the authorisation of omega-3 in secondary prevention after MI suffered from some methodological limitations and was weak and that the efficacy in this indication was not demonstrated in subsequent and more robust clinical trials.
Danish: Indehaverne af markedsføringstilladelse er ikke enige med CHMP i, at den evidens, der understøttede godkendelsen af omega-3 til sekundær forebyggelse efter hjerteinfarkt, havde metodemæssige begrænsninger og var svag, eller at virkningen i denne indikation ikke er blevet påvist i efterfølgende, mere robuste kliniske studier.
English: Therefore if omega-3 fatty acids are effective in reducing cardiovascular events after an MI, cardiovascular benefits in other CV risk populations (e.g. coronary revascularisation, angina pectoris, ischaemic stroke) can be anticipated.
Danish: Hvis omega-3fedtsyrer er effektive til at reducere kardiovaskulære hændelser efter et hjerteinfarkt, må man derfor forvente at se kardiovaskulære fordele i andre populationer med kardiovaskulær risiko (f.eks. koronar revaskularisering, angina pectoris, iskæmisk slagtilfælde).
English: In addition, it may be questioned if the results are relevant in the context of current MI standard of care which has substantially evolved since the time the study was performed and secondary prevention of CVD.
Danish: Derudover kan der sættes spørgsmålstegn ved, om resultaterne er relevante for sekundær forebyggelse af kardiovaskulære sygdomme, idet den aktuelle hjerteinfarkt-standardbehandling har udviklet sig betragteligt siden studiets gennemførelse.
English: In view of all the available data, the CHMP considered that the evidence that supported the authorisation of omega-3 in secondary prevention after MI suffered from some methodological limitations and was weak.
Danish: På grundlag af de tilgængelige data vurderede CHMP, at den evidens, der understøttede godkendelsen af omega-3 til sekundær forebyggelse efter hjerteinfarkt, havde en række metodemæssige begrænsninger, og at den var svag.
English: Although CHMP considers that the GISSI-P and the OMEGA trials are the most relevant for evaluating the effect of omega-3 containing products in the secondary prevention after MI, it is also acknowledged that RCTs (GISSI-HF, ORIGIN, SU.FOL.OM3) conducted in other CV risk populations (e.g. coronary revascularisation, angina pectoris, ischaemic stroke) are as well relevant, as CV disease is still considered a continuum.
Danish: Selvom CHMP vurderer, at GISSI-P og OMEGA er de mest relevante studier til vurdering af virkningen ved omega-3-holdige produkter til sekundær forebyggelse efter et hjerteinfarkt, anerkendes det også, at randomiserede kontrollerede studier (GISSI-HF, ORIGIN, SU.FOL.OM3), der er udført hos andre populationer med kardiovaskulær risiko (f.eks. koronar revaskularisering, angina pectoris, iskæmisk slagtilfælde), også er relevante, da kardiovaskulær sygdom stadig anses som et kontinuum.
English: The results of the meta-analyses by Aung et al. and the recent Cochrane review, even though they include trials with products, doses and populations not exactly representing the approved secondary prevention indication, are considered relevant as all studies include patients with cardiovascular disease and therefore are supportive of lack of efficacy.
Danish: Resultaterne af metaanalyserne, som Aung et al. har udført, og den nylige Cochrane-gennemgang (om end der er tale om studier med produkter, doser og populationer, der ikke fuldt ud repræsenterer den godkendte indikation (sekundær forebyggelse) anses som relevante, da alle studier omfatter patienter med kardiovaskulær sygdom og derfor understøtter en manglende virkning.
English: The results of the recently published REDUCE-IT trial are of limited relevance since the daily dose was much higher than the dose of the indication under review (4 g vs. 1 g) and the active substance was icosapent ethyl, a highly purified EPA ethyl ester, instead of a mixture of EPA and DHA.
Danish: Resultaterne af det nyligt offentliggjorte REDUCEIT-studie har begrænset relevans, da den daglige dosis var meget højere end dosen i den omhandlede indikation (4 g vs. 1 g), og da det aktive stof var icosapentethyl, en stærkt oprenset EPA-ethylester, og ikke en blanding af EPA og DHA.
English: The results of RECUCE-IT study results are of limited relevance since the daily dose was much higher than the dose of the indication under review (4 g vs 1 g) and the active substance was icosapent ethyl, a highly purified EPA ethyl ester, instead of a mixture of EPA and DHA.
Danish: Resultaterne af RECUCE-IT-studiet har begrænset relevans, da den daglige dosis var meget højere end dosen i den omhandlede indikation (4 g vs. 1 g), og da det aktive stof var icosapentethyl, en stærkt oprenset EPA-ethylester, og ikke en blanding af EPA og DHA.
English: Based on the totality of the data emerging after the original approval as well as the serious limitations of the GISSI-P trial, the CHMP concluded that efficacy is not established in secondary cardiovascular prevention at the dose of 1 g/day and whereas the safety profile of omega-3 -acid ethyl esters is unchanged, the CHMP concluded that the benefit-risk balance in this indication is no longer favourable.
Danish: På grundlag af de samlede data, der er fremkommet efter den oprindelige godkendelse, samt de alvorlige begrænsninger i GISSI-P-studiet konkluderede CHMP, at virkningen ikke er fastslået i indikationen sekundær kardiovaskulær forebyggelse ved en dosis på 1 g/dag, og selvom sikkerhedsprofilen for omega-3-syreethylestere er uændret, er CHMP af den opfattelse, at benefit/riskforholdet i denne indikation ikke længere er positivt.
English: • Based on the totality of the data emerging after the original approval as well as the limitations of the GISSI-P trial, the CHMP concluded that efficacy is not established in secondary prevention after myocardial infarction at the dose of 1 g/day and, although the safety profile of omega-3 -acid ethyl esters is unchanged, the CHMP concluded that the benefit-risk balance in this indication is no longer favourable.
Danish: • På grundlag af de samlede data, der er fremkommet efter den oprindelige godkendelse, samt begrænsningerne i GISSI-P-studiet konkluderede CHMP, at virkningen af omega-3syreethylestere i en dosis på 1 g/dag som sekundær forebyggelse efter hjerteinfarkt ikke er fastslået, og selvom sikkerhedsprofilen for omega-3-syreethylestere er uændret, er CHMP af den opfattelse, at benefit/risk-forholdet i denne indikation ikke længere er positivt.
English: In addition, in other prospective randomised trials performed after the original approval (GISSI-HF, ORIGIN study and SU.FOL.OM3 performed between 2003 and 2012), as well as in meta-analyses (e.g. by Aung et al. 20184), the results from the GISSI-P study could also not be reproduced.
Danish: Desuden kunne resultaterne fra GISSI-P-studiet heller ikke genskabes i andre prospektive, randomiserede studier, der blev gennemført efter den oprindelige godkendelse (GISSI-HF-, ORIGINog SU.FOL.OM3-studierne (2003-2012)), eller i metaanalyser (f.eks. ved Aung et al., 20184).
English: beneficial effect of omega-3 for secondary prevention after myocardial infarction at the dose of 1 g/day is weak.
Danish: til sekundær forebyggelse efter hjerteinfarkt ved en dosis på 1 g/dag er svag.
English: • The CHMP considered the totality of the data submitted for omega-3 acid ethyl esters medicinal products with regard to their use in secondary prevention after myocardial infarction.
Danish: • CHMP vurderede de samlede oplysninger, der var fremlagt vedrørende omega-3syreethylester-holdige lægemidler til brug ved sekundær forebyggelse efter hjerteinfarkt.
English: • The Committee for Medicinal Products for Human Use (CHMP) considered the procedure under Article 31 of Directive 2001/83/EC for Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction.
Danish: • Udvalget for Lægemidler til Mennesker (CHMP) gennemførte proceduren vedrørende omega-3syreethylester-holdige lægemidler til oral anvendelse som sekundær forebyggelse efter hjerteinfarkt i henhold til artikel 31 i direktiv 2001/83/EF.
English: The Committee, as a consequence, considers that the benefit-risk balance of Omega-3 acid ethyl esters medicinal products for oral use in secondary prevention after myocardial infarction is not favourable.
Danish: CHMP vurderer, jf. ovenstående, at benefit/risk-forholdet for omega-3-syreethylester-holdige lægemidler til oral anvendelse til sekundær forebyggelse efter hjerteinfarkt ikke er positivt.
English: In addition to MI, ACS is also associated with unstable angina.
Danish: Akut koronart syndrom er ud over hjerteinfarkt også forbundet med ustabil angina.
English: The ASCEND and VITAL studies did not show an effect of omega3 fatty acids on the primary or secondary cardiovascular endpoints and, as such, were considered as negative studies.
Danish: I ASCEND og VITAL blev der ikke påvist nogen effekt af omega-3-fedtsyrer, hvad angår de primære og sekundære kardiovaskulære endepunkter, og disse
English: The MAHs have described the results from different RCTs to support the beneficial effect of omega-3 fatty acids in secondary prevention after an MI.
Danish: Indehaverne af markedsføringstilladelse har beskrevet resultaterne fra forskellige randomiserede kontrollerede studier til påvisning af den gavnlige effekt af omega-3-fedtsyrer til sekundær forebyggelse efter et hjerteinfarkt.
English: Therefore, the key concern that standard of care after MI has intensified since the time of the GISSI-P study, in particular statin therapy, beta-blockers and PCI, still remains.
Danish: Det er derfor stadig en væsentlig indvending, at standardbehandling efter hjerteinfarkt har udviklet sig, siden GISSI-P-studiet blev gennemført, navnlig i form af statin-behandling, betablokkere og PCI.
English: In conclusion, the level of evidence resulting from the GISSI-P trial to support a
Danish: Det må derfor konkluderes, at evidensen fra GISSI-P-studiet til støtte for en gavnlig effekt af omega-3
English: Upon request from the MAHs, a second SAG CVS meeting was convened on 19 March 2019.
Danish: På anmodning fra indehaverne af markedsføringstilladelse afholdt den videnskabelige rådgivende gruppe vedrørende kardiovaskulære sygdomme endnu et møde den 19. marts 2019.
English: The key concern of this study is that standard of care for the treatment of MI has evolved since the outcome of the GISSI-P trial in particular statin therapy, beta-blocker therapy and invasive treatment.
Danish: Det største problem ved GISSI-P er, at standardbehandlingen af hjerteinfarkt har udviklet sig siden udfaldet af studiet, navnlig med henblik på statiner, betablokkere og invasive indgreb.
English: However, some experts in the SAG saw a place in therapy for omega-3containing medicinal products in secondary prevention after MI.
Danish: Nogle af eksperterne i den videnskabelige rådgivende gruppe mente dog, at behandling med omega-3-holdige lægemidler til sekundær forebyggelse efter hjerteinfarkt kan have sin berettigelse.
English: The OMEGA trial was a large prospective, double blind, randomized study including a population highly representative of the target population including the use of standard of care treatment.
Danish: Det primære formål med OMEGA-studiet var at undersøge forekomsten af pludselig hjertedød ved at teste én af de formodede virkningsmekanismer (antiarytmisk effekt) for omega-3 i GISSI-P. OMEGA-studiet var et stort prospektivt, dobbeltblindet, randomiseret studie med deltagelse af en gruppe forsøgspersoner, der var meget repræsentativ for målpopulationen, herunder i forhold til brugen af standardbehandling.
English: In the MAHs' view, GISSI‐P represented the mainstay of evidence in favour of the use of omega-3 fatty acids in the secondary prevention after MI and it is a valid and robust study.
Danish: Ifølge indehaverne af markedsføringstilladelse udgør GISSI‐P i sin egenskab af et validt og robust studie den væsentligste evidens for en gavnlig effekt af omega-3-fedtsyrer til sekundær forebyggelse efter et hjerteinfarkt.
English: Associations of Omega-3 Fatty Acid Supplement Use With Cardiovascular Disease Risks: Meta-analysis of 10 Trials Involving 77917 Individuals.
Danish: 4 Aung T, Halsey J, Kromhout D, Gerstein HC, Marchioli R, Tavazzi L, et al. Associations of Omega-3 Fatty Acid Supplement Use With Cardiovascular Disease Risks: Meta-analysis of 10 Trials Involving 77917 Individuals.
English: 27 November 2015 EMA/134144/2015
Danish: Den 27. november 2015 EMA/134144/2015
English: • During the switch to this type of combination medicine and in the weeks after the switch you should measure your blood sugar levels more frequently.
Danish: • Når du skifter til denne type kombinationsmedicin og i ugerne derefter bør du få målt blodsukkeret oftere.
English: • Ensure that your patients are adequately informed on how to use their medicine.
Danish: • Sørg for, at dine patienter er tilstrækkeligt informeret om, hvordan lægemidlet bruges.
English: An example of a diabetes medicine that contains insulin in combination with a non-insulin active substance is Xultophy (100 units/ml insulin degludec and 3.6 mg/ml liraglutide) which was authorised in the EU on.
Danish: Et eksempel på et sukkersygelægemidddel, der indeholder insulin i kombination med et andet aktivt stof, er Xultophy (100 enheder/ml insulin degludec og 3,6 mg/ml liraglutid), som blev godkendt i EU den.
English: Further information on the safe use of these medicines and other ways to minimise the possible risk of medication errors, can be found in the guidance on risk minimisation strategies for high strength and fixed combination insulin products.
Danish: Yderligere oplysninger om sikker brug af disse lægemidler og andre metoder til minimering af risikoen for medicineringsfejl findes i vejledning om strategier til risikominimering for højstyrkeinsulin og faste kombinationsprodukter med insulin.
English: Patients and healthcare professionals are therefore advised to take extra care when using these medicines and carefully follow the recommendations given below.
Danish: Patienter og sundhedspersoner tilrådes derfor at være ekstra forsigtige, når de bruger sådanne lægemidler, og nøje følge nedenstående anbefalinger.
English: However, there is a potential risk of patients receiving too little or too much of their medicine because of confusion that may arise over the way the doses are expressed for the individual components − the dose of the insulin is expressed in units while the dose of the non-insulin medicine may be expressed in other units such as mg.
Danish: Der er dog risiko for, at patienterne får for lidt eller for meget af medicinen, fordi der kan opstå forvirring om angivelsen af doserne for hver bestanddel − insulindosis angives i enheder, mens dosis af den anden bestanddel kan være angivet i andre enheder, f.eks. mg.
English: Before you use your medicine be clear on how many dose steps you require.
Danish: Før du bruger medicinen, skal du vide, hvor mange dosistrin du behøver.
English: These types of combination medicines are advantageous to patients since they reduce the number of injections they need to have and may help them keep to their treatment.
Danish: Sådanne kombinationspræparater er en fordel for patienterne, da de mindsker antallet af indsprøjtninger og kan gøre det lettere at overholde behandlingen.
English: • Read the instructions in your package leaflet carefully before using your medicine.
Danish: • Læs anvisningerne i indlægssedlen grundigt, før du bruger medicinen.
English: • Tell patients to closely monitor their blood sugar levels when starting a medicine containing insulin and a non-insulin active substance and in the weeks after.
Danish: • Fortæl patienterne, at de skal have overvåget blodsukkeret tæt, når de begynder på et lægemiddel, der foruden insulin indeholder et andet aktivt stof, og i flere uger bagefter.
English: In addition, healthcare professionals are encouraged to take the following precautions when storing, prescribing and dispensing diabetes medicines that contain insulin in combination with a non-insulin active substance:
Danish: Sundhedspersoner opfordres derudover til at træffe følgende forholdsregler ved opbevaring, ordination og udlevering af diabetesmedicin, der indeholder insulin i kombination med et andet aktivt stof:
English: • If the patient has been transferred from another pen device, highlight the differences in design between the two devices.
Danish: • Hvis patienten skifter fra en anden pen, skal du forklare forskellene mellem de to anordninger.
English: • One dose step contains a set number of units of insulin plus a fixed amount of the non-insulin medicine.
Danish: • Et dosistrin indeholder et bestemt antal enheder insulin plus en fast mængde af den anden bestanddel, som ikke er insulin.
English: Always prescribe the dose of insulin and the dose of non-insulin to be injected as well as the dose frequency.
Danish: Ordinér altid dosis af insulin og dosis af det andet lægemiddel, der skal injiceres, foruden dosishyppigheden.
English: • Your healthcare professional will explain the design and features of your pen, including how the dose counter of the pen device shows the number of dose steps to be injected.
Danish: • Din sundhedsperson vil forklare opbygningen af din pen, dens funktioner og hvordan pennens dosistæller viser det antal dosistrin, der skal indsprøjtes.
English: Recently, diabetes medicines that contain insulin in combination with a non-insulin active substance have been approved in the EU.
Danish: Der er for nylig i EU godkendt sukkersygelægemidler, der indeholder insulin i kombination med et andet aktivt stof.
English: • If you have any questions about your treatment speak to your healthcare professional.
Danish: • Spørg din sundhedsperson, hvis der er mere, du vil vide om behandlingen.
English: • Pharmacists are encouraged to check that patients and carers are able to read the dose counter of the pen device before dispensing the medicine.
Danish: • Apotekspersonale opfordres til inden lægemidlet udleveres at kontrollere, at patienter og omsorgsgivere er i stand til at aflæse pennens dosistæller.
English: Wash and disinfect hands after use.
Danish: Vask og desinficer hænderne efter anvendelsen.
English: No special precautions.
Danish: Ingen specielle forbehold.
English: Date of first authorisation: 14/04/2003 Date of last renewal: 11/03/2008
Danish: Dato for første markedsføringstilladelse: 14/04/2003 Dato for seneste fornyelse af markedsføringstilladelse: 11/03/2008
English: No undesirable effects have been observed after the administration of twice the recommended dosage.
Danish: Ingen bivirkninger er iagttaget efter administration af det dobbelte af den anbefalede dosis.
English: Manufacturing authorisation issued by the French Ministère des Affaires Sociales, Ministère délégué à la Santé, and the Ministère de l'Agriculture et de la Forêt on 31 March 1992.
Danish: Virksomhedsgodkendelse udstedt den 31. marts 1992 af det franske Ministère des Affaires Sociales, Ministère délégué à la Santé og Ministère de l'Agriculture et de la Forêt.
English: 5 to 7 weeks before farrowing
Danish: 5-7 uger før faring
English: Annex II of Council Regulation (EEC) No 2377/90 Pharmacologically active substance(s)
Danish: Bilag II til Rådets forordning (EØF) nr. 2377/90 Farmakologisk aktive stoffer
English: EXP {month/year}
Danish: EXP (måned/år)
English: Revaccination: 1 injection 2 weeks before each subsequent farrowing.
Danish: Revaccination 1 injektion 2 uger før hver efterfølgende faring.
English: Per dose of 2 ml:
Danish: Per dosis à 2 ml:
English: Vaccination may cause a slight hyperthermia (less than 1.5°C during a maximum period of 24 hours).
Danish: Vaccination kan forårsage let hyperthermi (mindre end 1,5°C i højst 24 timer).
English: Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
Danish: Vaccinens sikkerhed og virkning ved samtidig brug af andre vacciner (enten samme dag eller på andre tidspunkter) er derfor ikke påvist.
English: - Vaccinate only healthy animals.
Danish: − Vacciner kun raske dyr.
English: Laboratoire de Toulouse 4 Chemin du Calquet 31300 TOULOUSE FRANCE
Danish: Laboratoire de Toulouse 4, Chemin du Calquet 31300 TOULOUSE FRANKRIG
English: - Since the protection of piglets is ensured by colostrum intake, each piglet should ingest a sufficient quantity of colostrum within 6 hours of birth.
Danish: − Da beskyttelse af pattegrisene foregår ved optagelse af kolostrum, bør det sikres, at den enkelte pattegris optager passende mængde kolostrum inden for de første 6 levetimer.
English: Store and transport between 2ºC and 8ºC, protected from light.
Danish: Opbevares og transporteres ved 2ºC - 8ºC, beskyttet mod lys.
English: Intramuscular injection in the neck in the area behind the ear.
Danish: Intramuskulær injektion i nakken bag øret.
English: Administer using aseptic procedures.
Danish: Anvend sædvanlig aseptisk procedure.
English: - Do not administer in conjunction with other medicinal products.
Danish: − Bør ikke administreres sammen med andre lægemidler.
English: 2 weeks before farrowing.
Danish: 2 uger før faring
English: All food producing species
Danish: Alle arter bestemt til levnedsmiddelproduktion
English: Shelf-life: 18 months at 2 - 8 °C.
Danish: 18 måneder ved 2 - 8°C.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency https://www.ema.europa.eu/
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur http://ema.europa.eu
English: Do not mix with any other vaccine.
Danish: Bør ikke blandes med andre vacciner.
English: No information is available on the compatibility of this vaccine with any other.
Danish: Der foreligger ingen oplysninger om anvendelse af denne vaccine sammen med andre vacciner.
English: DATE OF FIRST RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktivt stof (Aktive stoffer):
English: Adhesins:
Danish: Adhesiner:
English: All food producing species For use only as a preservative in multidose vaccines at a concentration not exceeding 0.02%
Danish: Kun til anvendelse som konserveringsmiddel i flerdosisvacciner i en koncentration, som ikke overstiger
English: 1 OJ No L 290 of 05.12.95 2 OJ No L 110 of 26.04.97 3 OJ No L 272 of 25.10.96 4 OJ No L 290 of 05.12.95 5 OJ No L 143 of 27.06.95
Danish: 1 EFT nr. L 290 af 05.12.1995 2 EFT nr. L 110 af 26.04.1997 3 EFT nr. L 272 af 25.10.1996 4 EFT nr. L 290 af 05.12.1995 5 EFT nr. L 143 af 27.06.1995
English: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Danish: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein TYSKLAND
English: ATC vet code: QI09AB02
Danish: QI09AB02
English: MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Danish: Indehaver af markedsføringstilladelse: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/ Rhein TYSKLAND
English: Use sterile syringe and needles.
Danish: Anvend sterile sprøjter og kanyler.