FrancophonIA/ELRC3.0 huggingface dataset:
English: • The study was designed to assess the effect of adding nicotinic acid / laropiprant to statins on a composite endpoint of major vascular events, which included the combination of coronary death, non-fatal heart attack, stroke and revascularisation.
Danish: • Undersøgelsen var udformet med henblik på at vurdere virkningen af at tilføje nicotinsyre/laropiprant til statiner med det sammensatte endepunkt større kardiovaskulære hændelser, der omfattede dødsfald på grund af koronarsygdom, ikke-fatalt hjerteanfald, apopleksi og revaskularisering.
English: Doctors should no longer prescribe Tredaptive, Pelzont or Trevaclyn and should review patients' treatment options.
Danish: Læger skal ikke længere ordinere Tredaptive, Pelzont eller Trevaclyn, men gennemgå patientens behandlingsmuligheder.
English: • In light of the unfavourable benefit-risk balance of Tredaptive, Pelzont and Trevaclyn, doctors should no longer prescribe these medicines to their patients.
Danish: • På baggrund af det negative benefit/risk-forhold for Tredaptive, Pelzont og Trevaclyn skal lægen ikke længere ordinere disse lægemidler.
English: • Treatment with nicotinic acid / laropiprant together with a statin did not result in a statistically significant reduction in major vascular events such as heart attack and stroke compared with statin therapy alone.
Danish: • Behandling med nicotinsyre/laropiprant sammen med et statin resulterede ikke i statistisk signifikant reduktion i større vaskulære hændelser såsom hjerteanfald og apopleksi i forhold til statinbehandling alene.
English: • If you are taking Tredaptive, Pelzont or Trevaclyn you will have to discontinue treatment, as these medicines are no longer available in the EU.
Danish: • Hvis du bruger Tredaptive, Pelzont eller Trevaclyn, må du holde op med at bruge dem, da disse lægemidler ikke længere er på markedet i EU.
English: • Pharmacists should refer patients on new or repeated prescriptions for Tredaptive, Pelzont and Trevaclyn to the treating doctor.
Danish: • Patienter, der har en ny eller fornyet recept på Tredaptive, Pelzont eller Trevaclyn, bør af apoteket henvises til at gå til den behandlende læge.
English: The results of the study, which are still preliminary, indicated that taking nicotinic acid / laropiprant together with a statin has no significant additional benefit in reducing the risk of major vascular events such as heart attack and stroke, compared with statin therapy alone.
Danish: Undersøgelsens resultater er stadig foreløbige, men viste, at anvendelse af nicotinsyre/laropiprant sammen med et statin ikke giver nævneværdig ekstra fordel i form af mindsket risiko for større vaskulære hændelser såsom hjerteanfald og slagtilfælde i forhold til statinbehandling alene.
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Danish: Bilag I Liste over lægemidlernes navne, lægemiddelform(er), styrke(r), administrationsvej(e), indehaver(e) af markedsføringstilladelser i medlemsstaterne
English: 85-619 Bydgoszcz Poland
Danish: 85-619 Bydgoszcz Polen
English: Avenida de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
Danish: Avenida de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spanien
English: 92931 Paris La Défense Cedex France
Danish: 92931 Paris La Défense Cedex Frankrig
English: 92700 Colombes France
Danish: 92700 Colombes Frankrig
English: Industriestrasse 25, D-83607 Holzkirchen, Germany
Danish: Industriestrasse 25, D-83607 Holzkirchen, Tyskland
English: Floridsdorfer Hauptstraße 1 1210 Vienna
Danish: Floridsdorfer Hauptstraße 1 1210 Wien
English: Rösch & Handel Scheringgasse 2/Objekt 2 1140 Vienna
Danish: Rösch & Handel Scheringgasse 2/Objekt 2 1140 Wien
English: 150 00 Prague 5
Danish: 150 00 Prag
English: Pfizer Europe MA EEIG Ramsgate Road CT13 9 NJ Kent, Sandwich United Kingdom
Danish: Pfizer Europe MA EEIG Ramsgate Road CT13 9 NJ Kent, Sandwich Storbritannien
English: Via Scarlatti Domenico, 31 20124 Milano Italy
Danish: Via Scarlatti Domenico, 31 20124 Milano Italien
English: Largo Umberto Boccioni, 1 21040 Origgio - Varese Italy
Danish: Largo Umberto Boccioni, 1 21040 Origgio - Varese Italien
English: Modifiedrelease capsule, hard
Danish: Hård kapsel med modificeret udløsning
English: PRT Lagoas Park, Edifício 10 Porto Salvo
Danish: Laboratórios Pfizer, Lda PRT Lagoas Park, Edifício 10 Porto Salvo
English: Kwizda Pharma GmbH Effingergasse 21 1160 Vienna Austria
Danish: Kwizda Pharma GmbH Effingergasse 21 1160 Wien
English: Luxembourg film-coated tablets oral use
Danish: Luxembourg filmovertrukne tabletter
English: SERMION 5 mg, poudre pour solution pour perfusion powder for solution for infusion intravenous use
Danish: SERMION 5 mg, poudre pour solution pour perfusion pulver til opløsning til infusion intravenøs anvendelse
English: 10 mg/ml powder and solvent per oral solution
Danish: 10 mg/ml pulver og solvens til oral opløsning
English: 50 Latina (LT) , Italy
Danish: 50 Latina (LT), Italien
English: B-dul Theodor Pallady nr. 44C Sector 3, Bucureşti, Romania
Danish: B-dul Theodor Pallady nr. 44C Sector 3, Bucureşti, Rumænien
English: Sandoz d.d.,Verovškova 57, 1000 Ljubljana, Slovenia
Danish: Sandoz d.d.,Verovškova 57, 1000 Ljubljana, Slovenien
English: NICERIUM® 30 UNO 30 mg
Danish: NICERIUM® 30 UN 30 mg
English: S.C. LABORMED PHARMA S.A. Bd. Theodor Pallady nr. 44 B, sector 3, Bucureşti, Romania
Danish: S.C. LABORMED PHARMA S.A. Bd. Theodor Pallady nr.44 B, sector 3, Bucureşti, Rumænien
English: 4 mg/4 ml powder and solvent for solution for injection intramuscular and intravenous use
Danish: 4 mg/ml pulver og solvens til opløsning til injektion intramuskulær og intravenøs anvendelse
English: Pfizer Italia srl Via Isonzo, 71 04100 Latina Italy
Danish: Pfizer Italia srl Via Isonzo, 71 04100 Latina Italien
English: Ergotop 20 mgFilmtabletten
Danish: Ergotop 20 mgTabletten
English: Angenerico spa Via Nocera Umbra, 75 00181 Roma Italy
Danish: Angenerico spa Via Nocera Umbra, 75
English: 50 Latina (LT) ,Italy
Danish: Latina (LT), Italien
English: Pfizer Italia S.r.l., Via Isonzo 71, 04100 Latina, Italy film-coated tablets oral use
Danish: Pfizer Italia S.r.l., Via Isonzo 71, 04100 Latina, Italien filmovertrukne tabletter
English: Pfizer Italia srl Via Isonzo, 71 04100 Latina Italy soluble tablet
Danish: Pfizer Italia srl Via Isonzo, 71 04100 Latina Italien opløselig tablet
English: Nicergolin powder and solvent for solution for injection intramuscular use intravenous use
Danish: Nicergolin pulver og solvens til opløsning til injektion intramuskulær anvendelse intravenøs anvendelse
English: Powder and solvent for solution for injection intramuscular use intravenous use
Danish: Pulver og solvens til opløsning til injektion intramuskulær anvendelse intravenøs anvendelse
English: Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenia capsules, hard oral use
Danish: Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenien hårde kapsler
English: Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenia film-coated tablets oral use
Danish: Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenien filmovertrukne tabletter
English: Ergotop 30 mgFilmtabletten
Danish: Ergotop 30 mg - Filmtabletten
English: Sermion 30 mgFilmtabletten
Danish: Sermion 30 mg - Filmtabletten
English: 25 October 2013 EMA/565019/2013
Danish: Den 23. oktober 2013 EMA/565019/2013
English: Healthcare professionals will be informed in writing of the updated recommendations.
Danish: Sundhedspersoner vil blive orienteret skriftligt om de ajourførte anbefalinger.
English: The review of short-acting beta-agonists was initiated in November 2012 at the request of the Hungarian medicines agency, under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af korttidsvirkende betareceptorstimulerende midler blev indledt i november 2012 på anmodning af den ungarske lægemiddelstyrelse i henhold til artikel 31 i direktiv 2001/83/EF.
English: The medicines are called ‘short acting' because they work quickly, usually having an effect in less than five minutes, which lasts for several hours.
Danish: Lægemidlerne kaldes “korttidsvirkende”, fordi de virker hurtigt, sædvanligvis i løbet af mindre end fem minutter, og virkningen varer i adskillige timer.
English: The reviewed data originated from clinical studies, post-marketing reports and the published literature.
Danish: De gennemgåede data hidrørte fra kliniske undersøgelser, indberetninger efter markedsføring og den publicerede litteratur.
English: • If you are given these medicines for premature labour in this way, your doctor will monitor you and your baby during treatment and stop treatment if there are any signs of heart problems.
Danish: • Hvis du får disse lægemidler til vehæmning på denne måde, vil lægen overvåge dig og dit barn under behandlingen og standse behandlingen, hvis der er tegn på hjerteproblemer.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: CMDh er et organ, der repræsenterer EU's medlemsstater, og har ansvar for at sikre harmoniserede sikkerhedsnormer for lægemidler, der godkendes ved nationale procedurer i hele EU.
English: Oral and suppository formulations which are only authorised in obstetric indications will have their marketing authorisations revoked and shall be removed from the market by the Marketing Authorisation Holders by 25th November 2013 at the latest.
Danish: For de orale formuleringer og suppositorieformuleringer, der kun er godkendt til obstetriske indikationer, vil markedsføringstilladelserne blive inddraget, og indehaverne af markedsføringstilladelse skal have taget dem af markedet senest den 25. november 2013.
English: As the PRAC recommendations have been endorsed by consensus by the CMDh, they will now be implemented directly in all Member States, according to an agreed timetable.
Danish: Da PRAC's anbefalinger er vedtaget enstemmigt af CMDh, vil de nu blive gennemført direkte af alle medlemsstater i henhold til den aftalte tidsplan.
English: Short-acting beta-agonists have been authorised by national procedures in several European Union (EU) Member States, and have been marketed for many years under various trade names.
Danish: Korttidsvirkende beta-agonister har været godkendt ved nationale procedurer i en række EUmedlemsstater og har været på markedet i mange år under forskellige handelsnavne.
English: As the CMDh position was adopted by consensus, it will be directly implemented by the Member States where these medicines are authorised.
Danish: Da CMDh's standpunkt blev vedtaget enstemmigt, vil det blive direkte gennemført i de medlemsstater, hvor disse lægemidler er godkendt.
English: It proposed revising their prescribing information, with reinforced warnings on the cardiovascular risks.
Danish: Udvalget foreslog at revidere produktinformationen for disse lægemidler med skærpede advarsler om de kardiovaskulære risici.
English: As short-acting beta-agonists are all authorised nationally, the PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: Eftersom korttidsvirkende betareceptorstimulerende midler alle er godkendt nationalt, blev anbefalingerne fra PRAC fremsendt til Koordinationsgruppen vedrørende gensidig anerkendelse og decentralprocedure - lægmidler til mennesker (CMDh).
English: This timeframe can allow healthcare professionals to take other measures known to improve the health of the baby around the time of birth.
Danish: Dette giver sundhedspersoner tid til at træffe andre foranstaltninger til forbedring af den nyfødtes sundhedstilstand omkring fødselstidspunktet.
English: They are available as tablets, oral solutions, solutions for injection or infusion, and suppositories.
Danish: De leveres som tabletter, orale opløsninger, injektions- eller infusionsvæsker og suppositorier.
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1 has endorsed by consensus new recommendations to restrict the use of medicines called ‘short-acting beta-agonists'.
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - lægemidler til mennesker (CMDh) 1 har uden afstemning vedtaget nye anbefalinger, der begrænser anvendelsen af lægemidler i gruppen korttidsvirkende beta-agonister.
English: • Although these medicines are also used for the treatment of asthma, they are usually given at lower doses for this condition; if you are being treated with short-acting beta-agonists and have any questions or concerns about your treatment, speak to your doctor or pharmacist.
Danish: • Disse lægemidler anvendes desuden til astmabehandling, men normalt i lavere doser; hvis du er i behandling med korttidsvirkende beta-agonister og har spørgsmål til behandlingen, skal du tale med din læge eller apoteker.
English: However, injectable forms of these medicines can still be given for short-term obstetric use under specific conditions.
Danish: Som injektionspræparater kan de dog stadig anvendes til kortvarig obstetrisk brug under visse betingelser.
English: However, their use should be limited to pregnant women between 22 and 37 weeks of gestation and women receiving these medicines should be kept under specialist supervision for the duration of treatment, which is limited to a maximum of 48 hours.
Danish: De bør imidlertid kun anvendes mellem 22. og 37. graviditetsuge, og kvinder, der får disse lægemidler, bør være under opsyn af speciallæge i hele behandlingstiden, som højst må være 48 timer.
English: Short-acting beta-agonists work by stimulating a receptor on the surface of cells called the ‘beta-2 adrenergic receptor', which brings about smooth muscle relaxation.
Danish: Korttidsvirkende beta-agonister virker ved at stimulere en receptor på cellernes overflade, den såkaldte “beta-2-adrenerge receptor”, som virker afslappende på glatmuskulatur.
English: Smooth muscle is found in many organs, including on the inner linings of the airways, blood vessels, stomach and gut, and womb.
Danish: Glatmuskulatur findes i mange organer, bl.a. på de indre overflader af luftveje, blodkar, mavesæk og tarm samt livmoder.
English: The available data showed that injectable forms are effective at supressing labour contractions in the short term (up to 48 hours).
Danish: De foreliggende data viste, at injektionspræparaterne er effektive til kortvarigt (op til 48 timer) at hæmme sammentrækningerne af livmoderen.
English: Therefore, the PRAC concluded that the benefits of injectable forms of these medicines continue to outweigh their risks when used under specific conditions: these medicines should only be used to suppress premature labour for up to 48 hours, between the 22nd and the 37th weeks of pregnancy and under specialist supervision with continuous monitoring of the mother and the unborn baby.
Danish: PRAC konkluderede derfor, at fordelene ved disse lægemidler som injektionspræparater fortsat overstiger risiciene ved anvendelse under bestemte betingelser: Disse lægemidler bør kun anvendes til vehæmning ved truende for tidlig fødsel i op til 48 timer mellem 22. og 37. svangerskabsuge under opsyn af speciallæge og med uafbrudt overvågning af moderen og det ufødte barn.
English: • Parenteral short-acting beta-agonists are effective in the short-term and they can still be used in all authorised obstetric indications (inhibition of premature labour, external cephalic version, emergency use in specified conditions).
Danish: • Parenterale korttidsvirkende beta-agonister er effektive på kort sigt og kan fortsat anvendes til alle godkendte obstetriske indikationer (vehæmning ved truende for tidlig fødsel, ekstern fostervending, akut anvendelse under nærmere bestemte betingelser).
English: These recommendations follow a review of available cardiovascular safety data on the medicines fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol and terbutaline when used in obstetric indications.
Danish: Disse anbefalinger følger efter en gennemgang af de foreliggende kardiovaskulære sikkerhedsdata ved anvendelse af fenoterol, hexoprenalin, isoxsuprin, ritodrin, salbutamol og terbutalin til obstetriske indikationer.
English: • These medicines can still be given intravenously (into a vein) to suppress premature labour, but their use is limited to a maximum of 48 hours, and only in women between the 22nd and the 37th weeks of pregnancy.
Danish: • Disse lægemidler kan stadig gives i en vene (intravenøst) til vehæmning ved truende for tidlig fødsel, men højst i 48 timer, og kun mellem 22. og 37. svangerskabsuge.
English: • Given the identified cardiovascular adverse reaction profile and the very limited data supporting the benefits of oral forms and suppositories as short or long-term tocolytics, these formulations should no longer be used in any obstetric indication.
Danish: • På grund af den konstaterede kardiovaskulære bivirkningsprofil og de meget begrænsede data, der underbygger fordelene ved suppositorie- og orale former som kort- eller langtidsvirkende tokolytika, bør disse formuleringer ikke længere anvendes til nogen obstetrisk indikation.
English: The medicines included in the EU review are: fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol and terbutaline, which have been authorised for tocolytic treatment (to suppress labour contractions).
Danish: EUgennemgangen omfatter følgende lægemidler: fenoterol, hexoprenalin, isoxsuprin, ritodrin, salbutamol og terbutalin, som er godkendt til vehæmning (tokolytisk behandling).
English: These recommendations follow a review by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which looked into the known risk of cardiovascular side effects (problems affecting the heart and blood vessels) with high doses of short-acting beta-agonists when used as tocolytics (medicines that suppress labour contractions).
Danish: De nye anbefalinger følger efter en gennemgang foretaget af Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC), som undersøgte den velkendte risiko for bivirkninger fra hjerte-karsystemet (kardiovaskulære bivirkninger) ved anvendelse af høje doser korttidsvirkende beta-agonister til vehæmning (tokolytisk anvendelse).
English: • Parenteral short-acting beta-agonists should not be used in women with a history of heart disease or significant risk factors for heart disease or when prolongation of the pregnancy is hazardous to mother or fetus.
Danish: • Parenterale korttidsvirkende beta-agonister bør ikke anvendes til kvinder med hjertesygdom i anamnesen eller væsentlige risikofaktorer for hjertesygdom, eller når forlængelse af graviditeten er farlig for moderen eller fostret.
English: The PRAC concluded that there was a risk of serious cardiovascular side effects to both the mother and unborn baby when high-dose short-acting beta-agonists are used in obstetric indications, with the data suggesting these mostly occur with prolonged use.
Danish: PRAC konkluderede, at der er risiko for alvorlige kardiovaskulære bivirkninger for både moderen og det ufødte barn ved anvendelse af høje doser korttidsvirkende beta-agonister til obstetriske indikationer, og at dataene tyder på, at de hovedsagelig optræder ved langvarig anvendelse.
English: Given the cardiovascular risk and the very limited data on the effectiveness of the oral and suppository forms of these medicines, the PRAC concluded that their benefit-risk balance is not favourable and these medicines should no longer be used in obstetric indications.
Danish: På baggrund af den kardiovaskulære risiko og de meget begrænsede data om virkningen af disse lægemidler i oral form og som suppositorier konkluderede PRAC, at benefit/risk-forholdet af disse lægemidler ikke er gunstigt, og at de ikke længere bør anvendes til obstetriske indikationer.
English: • Because of a risk of problems affecting the heart and circulation to both the mother and unborn baby with high-dose short-acting beta-agonists, these medicines must not be used by mouth or as suppositories to suppress premature labour in pregnant women.
Danish: • På grund af risikoen for hjerte- og kredsløbsproblemer hos både moderen og det ufødte barn ved brug af høje doser af korttidsvirkende beta-agonister må disse lægemidler ikke anvendes til indgivelse gennem munden eller som suppositorier til vehæmning ved truende for tidlig fødsel.
English: The CMDh is a medicines regulatory body representing the European Union (EU) Member States recommended that they remain authorised in these indications.
Danish: CMDh er en lægemiddelmyndighed, der repræsenterer Den Europæiske Unions (EU's) medlemsstater.
English: • High-dose short-acting beta-agonists are associated with a risk of serious adverse cardiovascular events to both the mother and the fetus, particularly when used for a prolonged period of time.
Danish: • Højdosisbehandling med korttidsvirkende beta-agonister er forbundet med risiko for alvorlige kardiovaskulære hændelser for både moderen og fostret, navnlig ved langvarig anvendelse.
English: These medicines should no longer be used in oral or suppository forms in obstetric indications (for the care of pregnant women), such as for suppressing premature labour or excessive labour contractions.
Danish: Disse lægemidler bør i oral form eller som suppositorier ikke længere anvendes til vehæmning ved truende for tidlig fødsel eller for kraftige sammentrækninger af livmoderen.
English: In addition to oral medicines and suppositories, this review also covered injectable short-acting betaagonists used as tocolytics.
Danish: Gennemgangen af korttidsvirkende beta-agonister omfattede foruden orale former og suppositorier også injektionspræparater anvendt som tokolytika.
English: In countries where injectable forms are also authorised for external cephalic version (a method for moving the baby into the right position for birth) and emergency use in specific conditions, the PRAC
Danish: I lande, hvor injektionspræparaterne desuden er godkendt til udvendig vending af fosteret for at bringe dette i hovedstilling og til akut anvendelse under særlige betingelser,
English: Packaging
Danish: Emballagestørrelse
English: Similar results were seen in adults and in children.
Danish: Der blev observeret lignende resultater hos voksne og børn.
English: The results of the allergen challenge tests supported these results.
Danish: Resultaterne af allergenbelastningsundersøgelserne understøttede disse resultater.
English: If more than one type of eye treatment is being used, each one should be given at least 10 minutes apart and any eye ointments should be given last.
Danish: Hvis der anvendes mere end én type øjenbehandling, skal hver behandling gives med mindst 10 minutters mellemrum, og eventuelle øjensalver skal anvendes til sidst.
English: The full EPAR for Emadine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Emadine findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emadine on 27 January 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Emadine den 27. januar 1999.
English: This is a summary of the European public assessment report (EPAR) for Emadine.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Emadine.
English: The active substance in Emadine, emedastine, is an antihistamine.
Danish: Det aktive stof i Emadine, emedastin, er et antihistamin.
English: Emadine emedastine
Danish: Emadine emedastin