FrancophonIA/ELRC3.0 huggingface dataset:
English: How is Amgevita used?
Danish: Hvordan anvendes Amgevita?
English: For the full list of restrictions with Amgevita, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Amgevita fremgår af indlægssedlen.
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when there is no damage on X-ray but clear signs of inflammation
Danish: • aksial spondyloartritis (betændelse i rygsøjlen, som giver rygsmerter), herunder ankyloserende spondylitis, og når der er tydelige tegn på betændelse, men ved røntgen ikke ses nogen skader
English: What benefits of Amgevita have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Amgevita?
English: For practical information about using Amgevita, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Amgevita, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For information on the doses to be used for each condition and other information on the use of Amgevita, see the package leaflet.
Danish: Doseringsoplysningerne for de pågældende sygdomme samt andre oplysninger om anvendelsen af Amgevita fremgår af indlægssedlen.
English: weeks, there was an 81% improvement in symptom score with Amgevita compared with an 83% improvement with Humira.
Danish: I psoriasis-undersøgelsen, der omhandlede graden af forbedring efter 16 ugers behandling, var der en forbedring på 81 % i symptomscoren ved Amgevita sammenholdt med en forbedring på 83 % ved Humira.
English: Amgevita and other medicines of its class may also affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Danish: Amgevita og andre lægemidler i denne klasse kan også påvirke immunsystemets evne til at bekæmpe infektioner og kræft.
English: • Crohn's disease (a disease causing inflammation of the gut)
Danish: • Crohns sygdom (en sygdom, som forårsager betændelse i tarmen)
English: In the rheumatoid arthritis study, response was measured as a 20% or more improvement in symptom score after 24 weeks of treatment: 75% of those given Amgevita responded, compared with 72% of those given Humira.
Danish: I undersøgelsen af reumatoid artritis var responsen efter 24 ugers behandling en forbedring på 20 % eller mere i symptomscoren.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Amgevita have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Amgevita.
English: • rheumatoid arthritis (a disease causing inflammation of the joints)
Danish: • reumatoid artritis (en sygdom, som forårsager betændelse i leddene)
English: • ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut)
Danish: • ulcerøs kolitis (en sygdom, der medfører inflammation og sår i tarmslimhinden)
English: • hidradenitis suppurativa (acne inversa), a chronic skin disease that causes lumps, abscesses
Danish: • hidradenitis suppurativa (en kronisk hudsygdom, der giver knuder, abscesser (bylder) og ardannelse på huden
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints)
Danish: • psoriasisartritis (en sygdom, som fremkalder røde, afskallende pletter på huden og betændelse i leddene)
English: How does Amgevita work?
Danish: Hvordan virker Amgevita?
English: • plaque psoriasis (a disease causing red, scaly patches on the skin)
Danish: • plaquepsoriasis (en sygdom, der giver rød, skællende hud)
English: The European Commission issued a decision on 6 March 2009.
Danish: Europa-Kommissionen traf en afgørelse den 6. marts 2009.
English: The areas harmonised include:
Danish: De harmoniserede områder omfatter:
English: Dr Ian Hudson (UK)
Danish: Dr. Ian Hudson (Det Forenede Kongerige)
English: Tritace has been authorised in the EU since 1989, first in France and then in the following countries: Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.
Danish: Tritace har været godkendt i EU siden 1989, først i Frankrig dernæst i følgende lande: Østrig, Belgien, Bulgarien, Cypern, Tjekkiet, Danmark, Estland, Finland, Frankrig, Tyskland, Grækenland, Ungarn, Irland, Italien, Letland, Litauen, Luxembourg, Nederlandene, Norge, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige.
English: What is Tritace?
Danish: Hvad er Tritace?
English: This allows the heart to pump blood more easily, and the blood flow increases due to more blood being pumped into and through larger passageways.
Danish: Dette bevirker, at hjertet lettere kan pumpe blod, og blodgennemstrømningen øges, fordi der pumpes mere blod ind i og igennem større passager.
English: Tritace is authorised in the European Union (EU) via national procedures.
Danish: Tritace er godkendt i EU efter nationale procedurer.
English: Why was Tritace reviewed?
Danish: Hvorfor blev Tritace vurderet igen?
English: London, 18 March 2009 Doc.
Danish: London, den 18. marts 2009 Ref. dok.
English: Questions and answers on the referral for Tritace tablet and hard capsules containing ramipril 1.25 mg, 2.5 mg, 5 mg and 10 mg
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Tritacetabletter og hårde kapsler indeholdende ramipril 1,25 mg, 2,5 mg, 5 mg og 10 mg
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Danish: Artikel 30 i direktiv 2001/83/EF, med senere ændringer, indbringelse på baggrund af divergerende nationale beslutninger i medlemsstaterne.
English: 24 January 2008
Danish: 24. januar 2008
English: The CHMP endorsed six contraindications:
Danish: CHMP vedtog seks kontraindikationer:
English: Prof János Borvendég (HU)
Danish: Prof. János Borvendég (Ungarn)
English: The European Medicines Agency (EMEA) has completed a review of Tritace.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har foretaget en vurdering af Tritace.
English: The review was carried out under an ‘Article 30' referral1.
Danish: Vurderingen fandt sted inden for rammerne af en indbringelsesprocedure i henhold til artikel 301.
English: Ref. EMEA/CHMP/233264/2009
Danish: EMEA/202960/2009
English: • Hyperkalaemia
Danish: • Hyperkaliæmi
English: Tritace can also be available in the EU and the EEA under other trade names: Triatec, Triatec Hope, Cardace, Delix, Delix Protect, Delix Protect Startset, Delix P, Ramipril Winthrop, Ramipril Prevent, Loavel, Ramiwin, Ramipril Medgenerics, Ramilich, Tritace Titration, Acovil, Tritace Mite, Triateckit, Ramikit, Hypren, Ramace, Vesdil, Vesdil Protect, Ramipril-Zentiva, Unipril, Quark, Zenra, Pramace.
Danish: Tritace findes muligvis også i EU og EØS under følgende andre handelsbetegnelser: Triatec, Triatec Hope, Cardace, Delix, Delix Protect, Delix Protect Startset, Delix P, Ramipril Winthrop, Ramipril Prevent, Loavel, Ramiwin, Ramipril Medgenerics, Ramilich, Tritace Titration, Acovil, Tritace Mite, Triateckit, Ramikit, Hypren, Ramace, Vesdil, Vesdil Protect, Ramipril-Zentiva, Unipril, Quark, Zenra og Pramace.
English: On 3 January 2008 the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Tritace in the EU and the EEA.
Danish: Den 3. januar 2008 henviste Europa-Kommissionen sagen til Udvalget for Humanmedicinske Lægemidler (CHMP) med henblik på harmonisering af markedsføringstilladelserne for Tritace i EU og EØS.
English: Tritace is used to treat hypertension and symptomatic heart failure.
Danish: Tritace bruges til behandling af hypertension og symptomatisk hjerteinsufficiens.
English: When the production of angiotensin II is lowered, the blood vessels relax and widen.
Danish: Når angiotensin II-produktionen falder, afslappes og udvides blodkarrene.
English: This is in line with the recommendation of the CHMP's Pharmacovigilance Working Party on the use of ACE inhibitors in pregnancy.
Danish: Dette er i overensstemmelse med anbefalingen fra CHMP's arbejdsgruppe vedrørende lægemiddelovervågning i forbindelse med brug af ACE-hæmmere under graviditet.
English: 4.1 Therapeutic Indications
Danish: 4.1 Terapeutiske indikationer
English: The company that markets it is Sanofi-aventis
Danish: Det markedsføres af virksomheden Sanofi-aventis.
English: The CHMP decided to include under this section the harmonised wording:
Danish: CHMP besluttede at tilføje følgende harmoniserede formulering i dette afsnit:
English: When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Danish: Når graviditeten påvises, skal behandling med ACE-hæmmere/AIIRA øjeblikkeligt ophøre, og alternativ behandling skal om nødvendigt igangsættes (se pkt 4.3 og 4.6).
English: The CHMP recommended a contra indication only for the second and third trimester of pregnancy.
Danish: CHMP anbefalede kun en kontraindikation for graviditetens andet og tredje trimester.
English: • The CHMP agreed on the indication: Treatment of hypertension.
Danish: • CHMP vedtog indikationen: Behandling af hypertension.
English: The CHMP noted that there were contraindications present in one or several local SPCs.
Danish: CHMP bemærkede, at der var kontraindikationer i et eller flere lokale produktresuméer.
English: This has led to divergences across member states on the way the medicine can be used, as seen in the differences observed in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed.
Danish: Dette har medført afvigelser i lægemidlets anvendelsesmåde i medlemsstaterne, som det fremgår af forskelle i produktresuméer, etiketter og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: • Hypotension and renal dysfunction after acute myocardial infarction occurred more frequently with ramipril than placebo in the target population in the AIRE study.
Danish: • Hypotension og nyredysfunktion efter akut myokardieinfarkt forekom hyppigere med ramipril end placebo i målpopulationen i AIRE-undersøgelsen.
English: • Neutropenia/agranulocytosis
Danish: • Neutropeni/agranulatocytose
English: Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Medmindre fortsat ACE-hæmmer-/AIIRA-terapi skønnes nødvendig, skal patienter, der planlægger graviditet, skifte til alternativ antihypertensiv behandling med bedre sikkerhedsprofiler for brug under graviditet.
English: The active substance in Tritace, ramipril, is an angiotensinconverting enzyme (ACE) inhibitor.
Danish: Det aktive stof i Tritace, ramipril, er en angiotensinkonverterende enzym(ACE)-hæmmer.
English: The CHMP agreed adding a seventh contraindication: Ramipril must not be used in patients in patients with hypotensive or haemodynamically unstable states
Danish: CHMP besluttede at tilføje en syvende kontraindikation: Ramipril må ikke anvendes til hypotensivt eller hæmodynamisk ustabile patienter.
English: The CHMP also noted that Tritace had an indication for nephroprotection in some countries.
Danish: CHMP bemærkede endvidere, at Tritace i visse lande er indiceret til nyrebeskyttelse.
English: • Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
Danish: • Ramipril må ikke anvendes til hypotensivt eller hæmodynamisk ustabile patienter.
English: The CHMP discussed the areas where there was a divergence identified in the dose recommendations per indication: For each indication, the posology is presented as starting dose, titration schedule, maintenance dose and maximum dose.
Danish: CHMP drøftede de områder, hvor der var afvigelser i doseringsvejledningen for den enkelte indikation: For hver indikation indeholder doseringsanvisningen startdosis, titreringsskema, vedligeholdelsesdosis og maksimumdosis.
English: Tritace is also used to prevent cardiovascular disease in patients who are at cardiovascular risk (such as patients who already have coronary artery disease), and to prevent any further heart attack (acute myocardial infarction [MI]) in patients who have already had one.
Danish: Tritace bruges også til at forebygge kardiovaskulære sygdomme hos patienter, som er i risikogruppen for kardiovaskulære sygdomme (såsom patienter, der allerede lider af koronararteriesygdom) og til at forebygge hjerteanfald (akut myokardieinfarkt) hos patienter, som allerede har haft et hjerteanfald.
English: ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
Danish: ACE-hæmmere sænker produktionen af angiotensin II, som er en kraftig vasokonstriktor (et stof, der forsnævrer blodkarrene).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tritace in the European Union (EU) and the European Economic Area (EEA).
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) er af den opfattelse, at der er behov for at harmonisere ordinationsoplysningerne for Tritace i Den Europæiske Union (EU) og Det Europæiske Økonomiske Samarbejdsområde (EØS).
English: • Manifest glomerular non-diabetic nephropathy as defined by macroproteinuria ≥ 3g/day
Danish: • Manifest glomerulær ikkediabetisk nefropati defineret som makroproteinuri ≥ 3g/dag
English: After discussion the CHMP agreed on including the harmonised indication: Treatment of renal disease
Danish: Efter at have diskuteret sagen besluttede CHMP at medtage den harmoniserede indikation: Behandling af nyresygdom.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de fremlagte oplysninger og den faglige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméet, etiketteringen og indlægssedlen skulle harmoniseres inden for EU.
English: • Pregnancy: ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Danish: • Graviditet: ACE-hæmmere såsom ramipril eller angiotensin II-receptorantagonister (AIIRA) bør ikke opstartes under graviditet.
English: • Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor
Danish: • Manifest glomerulær diabetisk nefropati defineret ved makroproteinuri hos patienter med mindst én kardiovaskulær risikofaktor
English: • Surgery: It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
Danish: • Operation: Det anbefales, at behandling med angiotensinkonverterende enzymhæmmere, såsom ramipril, bør ophøre én dag før operationen, såfremt det er muligt.
English: • When considering the indication in heart failure, the CHMP took into consideration previous harmonisations referrals for other ACE-inhibitors (enalapril, perindopril and lisinopril), and agreed on the indication: Treatment of symptomatic heart failure.
Danish: • I betragtning af indikationen for hjerteinsufficiens medtog CHMP de tidligere henvisninger af sager vedrørende harmonisering for andre ACE-hæmmere (enalapril, perindopril og lisinopril) i sine overvejelser og vedtog indikationen: Behandling af symptomatisk hjerteinsufficiens.
English: • Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5)
Danish: • Ekstrakorporale behandlinger, som medfører kontakt med blod med negativt ladede overflader
English: • The CHMP also discussed the indications in the treatment of cardiovascular secondary prevention, and primary prevention in high-risk patients, and endorsed the harmonised indication: Cardiovascular prevention: reduction cardiovascular morbidity and mortality in patients with: i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or ii) diabetes with at least one cardiovascular risk factor.
Danish: • CHMP diskuterede også indikationerne for behandling af kardiovaskulær sekundær profylakse og primær profylakse hos højrisikopatienter og godkendte den harmoniserede indikation: Kardiovaskulær profylakse: nedsættelse af kardiovaskulær morbiditet og mortalitet hos patienter med: i) manifest aterotrombotisk kardiovaskulær sygdom (anamnese med koronar hjertesygdom, slagtilfælde eller perifer vaskulær sygdom) eller ii) diabetes med mindst én kardiovaskulær risikofaktor.
English: • For the secondary prevention after MI in patients with heart failure, the CHMP endorsed the harmonised indication: Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started >48 hours following acute myocardial infarction.
Danish: • For den sekundære profylakse efter myokardieinfarkt hos patienter med hjerteinsufficiens godkendte CHMP den harmoniserede indikation: Sekundær profylakse efter akut myokardieinfarkt: nedsættelse af mortalitet af den akutte fase af myokardieinfarkt hos patienter med kliniske tegn på hjerteinsufficiens, når behandlingen påbegyndes > 48 timer efter akut myokardieinfarkt.
English: • Cough
Danish: • Hoste.
English: • 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6)
Danish: • Graviditet i andet og tredje trimester (se pkt.
English: • Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria
Danish: • Begyndende glomerulær diabetisk nefropati defineret ved tilstedeværelse af mikroalbuminuri
English: Tritace has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det er blevet bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentraliserede procedurer (CMD(h)), at Tritace bør harmoniseres.
English: • Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
Danish: • Signifikant bilateral nyrearteriestenose eller nyrearteriestenose i en enkelt fungerende nyre
English: Therefore the CHMP agreed on including the wording: Transient or persistent heart failure post MI
Danish: Derfor besluttede CHMP at tilføje formuleringen: Forbigående eller vedvarende hjerteinsufficiens efter myokardieinfarkt.
English: • Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin
Danish: • Overfølsomhed over for det aktive stof, et eller flere af hjælpestofferne eller nogen andre
English: • History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE
Danish: • Anamnese med angioødem (hereditært, idiopatisk eller tidligere angioødem med ACE-hæmmere eller AIIRA (angiotensin II-receptorantagonister))
English: Company responses provided on: 28 April 2008, 24 October 2008 Opinion date:
Danish: 28. april 2008, 24. oktober 2008
English: Converting Enzyme) inhibitors (see section 6.1)
Danish: ACE(angiotensinkonverterende enzym)-hæmmere (se pkt.
English: Withdrawal Period
Danish: Tilbageholdelses-tid
English: Strength Pharmaceutical Form
Danish: EU Nummer Handelsnavn Styrke Lægemiddelform
English: Content Package Size
Danish: Indgivelsesvej Emballage Indhold Pakningsstørrelse
English: Target Species Route of Administration
Danish: Dyrearter, som lægemidlet er beregnet til
English: This is called priapism.
Danish: Dette kaldes priapisme.
English: General supportive measures should be employed.
Danish: Generel understøttende foranstaltninger bør iværksættes.
English: This list is indicative and not exhaustive.
Danish: Denne liste er vejledende og ikke udtømmende.
English: Your doctor will tell you when you need your next injection.
Danish: Lægen fortæller dig, hvornår du behøver din næste indsprøjtning.
English: Tell your doctor immediately if you:
Danish: Fortæl det straks til din læge, hvis du:
English: The system is fully activated when a ‘click' is heard.
Danish: Systemet er fuldt aktiveret, når der høres et "klik".
English: The mechanism for this increased risk is not known.
Danish: Mekanismen bag denne øgede risiko er ukendt.
English: Note: Negative change in score indicates improvement.
Danish: Bemærk: En negativ ændring i scoren indikerer forbedring.
English: It is also recommended to alternate between left and right sides (see below).
Danish: Det anbefales endvidere at veksle mellem venstre og højre side (se nedenfor).
English: Not known: frequency cannot be estimated from the available data
Danish: Ikke kendt: hyppigheden kan ikke fastslås ud fra forhåndenværende data
English: Consequently, newborns should be monitored carefully.
Danish: Derfor bør nyfødte overvåges nøje.
English: IFIS may increase the risk of eye complications during and after the operation.
Danish: IFIS kan øge risikoen for øjenkomplikationer under og efter operationen.
English: The release of the active substance starts as early as day 1 and lasts for at least 4 months.
Danish: Frigivelsen af det aktive stof starter så tidligt som dag 1 og varer i mindst 4 måneder.
English: No clinically significant differences were observed between men and women.
Danish: Ingen klinisk signifikante forskelle blev observeret mellem mænd og kvinder.
English: Close supervision and monitoring should continue until the patient recovers.
Danish: Tæt medicinsk observation og monitorering skal fortsætte, indtil patienten er kommet sig.
English: The following side effects may happen:
Danish: Følgende bivirkninger kan forekomme:
English: Some patients may benefit from gradual withdrawal.
Danish: Visse patienter kan have fordel af gradvis seponering.
English: Children and adolescents This medicine is not for people who are under 18 years old.
Danish: Børn og unge Dette lægemiddel er ikke til personer under 18 år.
English: Significant weight gain may adversely affect your health.
Danish: Betydelig vægtstigning kan påvirke dit helbred negativt.
English: Dosing adjustments were only allowed in the first 12 weeks of the maintenance period.
Danish: Dosisjusteringer var kun tilladt i de første 12 uger af vedligeholdelsesperioden.
English: The suspension is white to off-white.
Danish: Suspensionen er hvid til off-white.
English: Schizophrenia is a disease with “positive” and “negative” symptoms.
Danish: Skizofreni er en sygdom med “positive” og “negative” symptomer.
English: It is important not to miss your scheduled dose.
Danish: Det er vigtigt, at du ikke går glip af den planlagte dosis.
English: It should be inspected visually for foreign matter before administration.
Danish: Den skal inspiceres visuelt for fremmedlegemer før administration.
English: The majority of these reactions were reported to be of mild to moderate severity.
Danish: Størstedelen af disse reaktioner var rapporteret som milde til moderate i sværhedsgrad.
English: It must not be administered by any other route.
Danish: Det må ikke administreres på nogen anden måde.
English: Agranulocytosis has been reported very rarely (< 1/10,000 patients) during post-marketing surveillance.
Danish: Agranulocytose er rapporteret meget sjældent (< 1/10.000 patienter) under postmarketingsovervågning.
English: Polysorbate 20
Danish: Polysorbat 20
English: or other parts of your body).
Danish: tungen eller andre dele af kroppen).