FrancophonIA/ELRC3.0 huggingface dataset:
English: Other sections such as those on special warnings, interactions and pregnancy and lactation were also harmonised.
Danish: Andre afsnit, herunder om særlige advarsler, interaktion og graviditet og amning, blev også harmoniseret.
English: Patients with impairment of kidney function may have to take lower doses.
Danish: Patienter med nedsat nyrefunktion skal muligvis tage lavere doser.
English: Treatment with diuretics (medicines that help increase the amount of water removed from the body in the urine) should, where possible, be stopped two to three days before starting treatment with Vascace.
Danish: Behandling med diuretika (lægemidler, som medvirker til at øge mængden af vand, der udskilles fra kroppen gennem urinen) skal om muligt ophøre to til tre dage, inden behandlingen med Vascace indledes.
English: Why was Vascace reviewed?
Danish: Hvorfor blev Vascace vurderet igen?
English: Vascace is also available in the EU under other trade names: Dynorm, Inhibace, Inibace, Justor and Vascase.
Danish: Vascace markedsføres ligeledes i EU under andre særnavne: Dynorm, Inhibace, Inibace, Justor og Vascase.
English: The usual dose is 2.5 to 5 mg per day.
Danish: Den sædvanlige dosis er 2,5 til 5 mg pr. dag.
English: On 16 September 2009, European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vascace in the EU.
Danish: Den 16. september 2009 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Vascace i EU.
English: It is used to treat hypertension and long-term heart failure (inability of the heart to pump enough blood around the body).
Danish: Det anvendes til behandling af hypertension og langvarig hjerteinsufficiens (hjertets manglende evne til at pumpe blod nok rundt i kroppen).
English: It blocks the action of the enzyme ACE, which is responsible for the production of a hormone in the body called angiotensin II.
Danish: Det blokerer virkningen af ACE-enzymet, som er ansvarligt for dannelsen af et hormon i kroppen kaldet angiotensin II.
English: By blocking the production of this hormone, cilazapril allows the blood vessels to widen, reducing the blood pressure.
Danish: Ved at blokere dannelsen af dette hormon gør cilazapril det muligt for blodkarrene at udvide sig, hvorved blodtrykket falder.
English: Vascace is a medicine that contains the active substance cilazapril.
Danish: Vascace er et lægemiddel, der indeholder det aktive stof cilazapril.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har medført, at lægemidlet blev anvendt på forskellige måder i medlemsstaterne, sådan som det fremgår af forskellene i produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: A lower starting dose of 0.5 mg is recommended for hypertension in patients with a highly activated ‘renin-angiotensin-aldosterone system' as they may experience an excessive drop in blood pressure.
Danish: En lavere startdosis på 0,5 mg anbefales ved hypertension hos patienter med et stærkt aktiveret "renin-angiotensin-aldosteronsystem", da disse kan opleve et for kraftigt fald i blodtrykket.
English: 7 July 2010
Danish: 7. juli 2010
English: The reduced blood pressure also helps patients with heart failure, because it is easier for the heart to pump out blood if the pressure in the blood vessels is not too high.
Danish: Et lavere blodtryk er også en fordel for patienter med hjerteinsufficiens, idet det er lettere for hjertet at pumpe blod ud, hvis trykket i blodkarrene ikke er for højt.
English: It must not be used in patients with angioedema (swelling beneath the skin) associated with previous treatment with ACE inhibitor or in patients with hereditary or idiopathic angioedema.
Danish: Det må ikke anvendes hos patienter med angioødem (hævelser under huden) forbundet med tidligere behandling med ACEhæmmere eller hos patienter med hereditært eller idiopatisk angioødem.
English: The CHMP agreed that Vascace should be used for the treatment of hypertension and chronic heart failure.
Danish: CHMP vedtog, at Vascace skal anvendes til behandling af hypertension og kronisk hjerteinsufficiens.
English: The European Medicines Agency has completed a review of Vascace.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en vurdering af Vascace.
English: If this dose is well tolerated by the patient, it can be increased to 1 or 2.5 mg once a day.
Danish: Hvis denne dosis er veltolereret af patienten, kan dosis øges til 1 mg eller 2,5 mg én gang daglig.
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 Vascace in the European Union (EU).
Danish: EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Vascace i Den Europæiske Union (EU).
English: The active substance in Vascace, cilazapril, is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Danish: Det aktive stof i Vascace, cilazapril, er en "angiotensinkonverterende enzymhæmmer" (ACE-hæmmer).
English: The Committee recommended that Vascace should not be used in patients who are hypersensitive (allergic) to cilazapril or to any other ingredients of the product, or to other ACE inhibitors.
Danish: CHMP anbefalede, at Vascace ikke bør anvendes hos patienter, som er hypertensive (allergiske) over for cilazapril, andre af indholdsstofferne i lægemidlet eller andre ACE-hæmmere.
English: For heart failure, the recommended starting dose is 0.5 mg once a day for one week.
Danish: Den anbefalede startdosis ved hjerteinsufficiens er 0,5 mg én gang daglig i en uge.
English: Vascace was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentraliserede procedurer (CMD(h)), at Vascace skulle harmoniseres.
English: Company responses provided on: 28 December 2009, 22 March 2010 Opinion date:
Danish: 28. december 2009, 22. marts 2010.
English: For hypertension, the recommended starting dose is 1 mg per day, which can be adjusted depending on how the patient's blood pressure responds.
Danish: Dosis kan tilpasses alt afhængig af, hvordan patientens blodtryk responderer på behandlingen.
English: • Do not store below 4°C.
Danish: • Må ikke opbevares ved temperaturer under 4 °C.
English: • Store in the original package.
Danish: • Opbevares i den originale pakning.
English: Flexible PVC container holding 1.5, 2.0 or 2.5 litres.
Danish: Fleksibel PVC beholder indeholdende 1,5, 2,0 eller 2,5 liter.
English: Changes are shown as greyed boxed wording
Danish: Ændringer er vist som tekst i grå bokse
English: • Do not use EXTRANEAL after the expiry date.
Danish: • Brug ikke EXTRANEAL efter den udløbsdato, der står på pakningen.
English: units per box
Danish: Koblingstype per kasse skrue
English: The product, once removed from its overpouch should be used immediately.
Danish: Når produktet er fjernet fra yderposen, skal det straks anvendes.
English: DIANEAL PD4 6.3 Shelf life
Danish: DIANEAL PD4
English: The shelf life of the product as packaged for sale is 24 months 12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only).
Danish: Opbevaringstid for produktet er 24 måneder 12 måneder (for lægemidler fremstillet hos Alliston, Canada og North Cove, USA).
English: Amendments to be included in the relevant sections of the summary of product characteristics and package leaflets for Dianeal PD4 and Extraneal, as applicable.
Danish: Ændringer som skal tilføjes relevante punkter i produktresumeet og indlægssedlen for Dianeal PD4 og Extraneal, efter behov.
English: Twin bag (lineo connector) Not all pack sizes may be marketed.
Danish: 4 enheder pr. kasse Duopose (lineokobling) Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: • Dispose EXTRANEAL as you have been trained
Danish: • Bortskaf EXTRANEAL på den måde, som du har fået at vide i undervisningen.
English: Amendments to the relevant sections of the summaries of product characteristics and package leaflets
Danish: Bilag III Ændringer til relevante punkter i produktresumeer og indlægssedler
English: The lineo connector that may equip the Y transfer line of the twin bag, contains 10.5% of Povidone iodine ointment
Danish: Y-overføringsslangen på duoposen kan være udstyret med en lineokobling, som indeholder 10,5 % povidonjodsalve.
English: 12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only).
Danish: 12 måneder (kun for lægemidler fremstillet hos Alliston, Canada og North Cove, USA) Produktet skal anvendes straks efter yderposen er fjernet.
English: 6.5 Nature and Contents of Container
Danish: 6.5 Emballagetyper og pakningsstørrelser
English: Product configuration
Danish: PRODUKTRESUME
English: Summary of Product Characteristics
Danish: Indhold Antal enheder
English: Number of
Danish: INDLÆGSSEDDEL
English: Overall summary of the scientific evaluation of polymyxin-based products (see Annex A and Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af polymyxinbaserede lægemidler (se bilag A og bilag I)
English: Corresponding changes were made to the package leaflets.
Danish: Tilsvarende ændringer blev foretaget af indlægssedlerne.
English: Data was also particularly limited for paediatric patients.
Danish: Også for pædiatriske patienter var data meget begrænsede.
English: It was agreed that colistin can be used without age restrictions, but only for the treatment of serious infections.
Danish: Det blev fastslået, colistin kan anvendes uden aldersbegrænsning, men kun til behandling af alvorlige infektioner.
English: Only polymyxin E (referred to as colistin) is approved for clinical use in the EU.
Danish: Kun polymyxin E (her benævnt colistin) er godkendt til klinisk brug i EU.
English: The scope of the procedure includes nationally-authorised medicinal products and a centrally-authorised medicinal product, Colobreathe (dry powder for inhalation), authorised in February 2012.
Danish: Proceduren omfatter nationalt godkendte lægemidler og ét centralt godkendte lægemiddel, Colobreathe (tørt inhalationspulver), der blev godkendt i februar 2012.
English: The emergence of multi-drug resistant Gram-negative bacteria that cause nosocomial infections is a growing problem worldwide.
Danish: Fremkomsten af multiresistente gramnegative bakterier, der forårsager sygehusinfektioner, er et voksende problem i hele verden.
English: In addition, differences across the world in the expression of the strength and dose of colistin products may result in medication errors and put patients at risk.
Danish: Desuden kan forskellene verden over i styrke- og dosisangivelse for colistinlægemidler medføre medicineringsfejl og bringe patienterne i risiko.
English: Polymyxins are a group of naturally occurring antibiotics produced by the bacterium Paenibacillus polymyxa.
Danish: Polymyxiner er en gruppe naturligt forekommende antibiotika, der produceres af bakterien Paenibacillus polymyxa.
English: For Colobreathe, referred to in Annex A, the CHMP recommended the maintenance of the marketing authorisation, without any variations to the term of the marketing authorisation.
Danish: For Colobreathe, som er omhandlet i bilag A, anbefalede CHMP opretholdelse af markedsføringstilladelsen uden ændringer af betingelserne for markedsføringstilladelsen.
English: The posology and method of administration section was also revised in its entirety, for all patient subpopulations, in order to define the optimal treatment regimens for achieving plasma concentrations above the critical minimal inhibitory concentrations.
Danish: Afsnittet om dosering og administration blev ligeledes revideret i sin helhed for alle patientundergrupper for at fastlægge de optimale behandlingsregimer til opnåelse af plasmakoncentrationer over de kritiske mindste hæmmende koncentrationer.
English: However, data was extremely limited in certain patient populations and as a result, no firm recommendations could be made for patients with renal impairment, on renal replacement therapy or with hepatic impairment.
Danish: For visse patientpopulationer var data imidlertid ekstremt begrænsede; der kan derfor ikke fremsættes faste anbefalinger ved nedsat nyrefunktion, nyresubstitutionsbehandling eller nedsat leverfunktion.
English: Polymyxins are currently listed among the critically important antimicrobials and in view of the importance of ensuring the availability of efficacious and safe antibiotics in order to efficiently respond to the threat posed by the spread of antimicrobial resistance, the European Commission initiated a procedure under Article 31 of Directive 2001/83/EC on 16 September 2013, requesting the CHMP to give its opinion on the benefit-risk of polymyxin-based products and on the need for regulatory measures.
Danish: Polymyxiner er opført som kritisk vigtige antimikrobielle midler, og i betragtning af vigtigheden af at råde over virksomme og sikre antibiotika til imødegåelse af truslerne fra udbredelsen af antimikrobiel resistens indledte Europa-Kommissionen den 16. september 2013 en procedure i henhold til artikel 31 i direktiv 2000/83/EF, idet Kommissionen anmodede CHMP om at fremsætte en udtalelse om benefit/risk-forholdet for polymyxinbaserede lægemidler og behovet for regulatoriske indgreb.
English: CMS for parenteral use is indicated for the treatment of serious infections caused by Gram-negative pathogens and CMS for inhalation use is indicated for the management of chronic pulmonary infections due to P. aeruginosa in patients with cystic fibrosis.
Danish: CMS til parenteral brug er indiceret til behandling af alvorlige infektioner med gramnegative patogener, og CMS til inhalationsbrug er indiceret til behandling af kroniske lungeinfektioner med P. aeruginosa hos patienter med cystisk fibrose.
English: A key concern is to maintain the efficacy of colistin against multi-drug resistant pathogens and to avoid the selection of resistance arising from monotherapy and the CHMP therefore agreed recommendations for the co-administration of parenteral colistin with other antibiotics.
Danish: Et hovedanliggende er at bevare virkningen af colistin mod multiresistente patogener og undgå selektion af resistente organismer som følge af monoterapi, og CHMP vedtog derfor anbefalingerne for koadministration af parenteralt colistin sammen med andre antibiotika.
English: Annex II Scientific conclusions and grounds for maintenance of the marketing authorisations or the variation to the terms of the marketing authorisations, as relevant
Danish: Bilag II Videnskabelige konklusioner og begrundelse for opretholdelse af markedsføringstilladelserne eller ændring af betingelserne for markedsføringstilladelserne, som relevant
English: • the CHMP considered that the dose and strength of polymyxin-based products should continue to be expressed in international units,
Danish: • CHMP fandt, at dosis og styrke af polymyxinbaserede lægemidler fortsat burde angives i internationale enheder.
English: Two forms of colistin are used clinically: colistin sulphate and its microbiologically inactive prodrug, colistimethate sodium (CMS).
Danish: Klinisk anvendes to forskellige former af colistin: colistinsulfat og det mikrobiologisk inaktive prodrug colistimethatnatrium (CMS).
English: The CHMP decided that the medical need was greatest for high dose products for parenteral and inhalation use and that the scope of the review should be limited to these medicinal products.
Danish: CHMP fastslog, at det medicinske behov var størst for højdosislægemidler til parenteral brug og inhalation, og at gennemgangen burde begrænses til sådanne lægemidler.
English: In its assessment, the CHMP reviewed all available data, including submissions by marketing authorisation holders during the procedure and consulted the Pharmacokinetics Working Party and the Infectious Disease Working Party.
Danish: I sin vurdering gennemgik CHMP alle foreliggende data, herunder dem, der var indsendt af indehaverne af markedsføringstilladelse under proceduren, og herudover konsulterede udvalget arbejdsgruppen vedrørende farmakokinetik og arbejdsgruppen vedrørende infektionssygdomme.
English: • the CHMP carried out a benefit-risk evaluation of polymyxin-based products under Article 31 of Directive 2001/83/EC, reviewing all available data, including responses submitted by the marketing authorisation holders during the procedure and recommendations from the Pharmacokinetics and the Infectious Disease working parties,
Danish: • CHMP foretog en benefit/risk-vurdering af polymyxin-baserede lægemidler i henhold til artikel 31 i direktiv 2001/83/EF med gennemgang af alle foreliggende data, herunder de ved proceduren modtagne besvarelser fra indehaverne af markedsføringstilladelse, samt anbefalinger fra arbejdsgrupperne vedrørende farmakokinetik og infektionssygdomme.
English: In particular, the CHMP considered that a loading dose should be administered, to ensure plasma concentrations above the minimum inhibitory concentration from the very first administration.
Danish: Herunder fandt CHMP, at der bør gives en støddosis for at sikre, at plasmakoncentrationerne er over den mindste hæmmende koncentration fra den allerførste administration.
English: However, the CHMP introduced a dose content conversion table between CMS expressed in IU, CMS expressed in mg and CBA expressed in mg, to raise awareness of the different ways of expressing the strength and dose and to help prescribers who obtain additional information from the literature.
Danish: CHMP indførte imidlertid en omregningstabel for dosis af CMS i IE, CMS i mg og CBA i mg for at udbrede kendskabet til de forskellige angivelsesmåder for styrke og dosis og gøre det lettere for de ordinerende læger at søge supplerende information i litteraturen.
English: Regarding the centrallyauthorised product Colobreathe, the CHMP considered the product information to be up to date, with no need for revision.
Danish: For det centralt godkendte lægemiddel Colobreathe fandt CHMP, at produktoplysningerne var ajour og ikke krævede revision.
English: Colistin has a relatively high level of toxicity associated with parenteral administration and CMS was therefore developed for parenteral and inhalation use.
Danish: Colistin er forholdsvis toksisk ved parenteral administration, hvorfor CMS blev udviklet til parenteral brug og inhalationsbrug.
English: Finally, extensive revisions were made to reflect current pharmacokinetic and pharmacodynamic data, including an update of the EUCAST breakpoints and the list of susceptible species.
Danish: Endelig blev der foretaget omfattende revisioner, der afspejler de nuværende farmakokinetiske og farmakodynamiske data, herunder ajourføringer af EUCAST-afskæringspunkterne og fortegnelsen over følsomme arter.
English: The CHMP also reviewed the data on adverse events observed with the use of colistin and agreed that the use of colistin for parenteral use is associated with nephrotoxicity and neurotoxicity but considered that these risks must be balanced against the risk of the underlying disease and the high mortality from the treated conditions and that they can be satisfactorily mitigated by statements in the SmPC.
Danish: CHMP gennemgik desuden data om de iagttagne bivirkninger ved anvendelse af colistin og fastslog, at parenteral anvendelse af colistin er forbundet med nefrotoksicitet og neurotoksicitet, men at disse risici må afvejes mod risikoen fra den underliggende sygdom og den høje dødelighed ved de behandlede tilstande og kan afbødes tilfredsstillende gennem angivelser i produktresuméet.
English: As a consequence, the existing preclinical and clinical pharmacokinetic (PK) and pharmacodynamic (PD) information is limited, the product information has not been significantly updated over the years and the dosage regimens in use today are not based upon robust PK/PD data.
Danish: Som følge heraf er de foreliggende prækliniske, kliniskfarmakokinetiske og farmakodynamiske oplysninger begrænsede, produktinformationen er ikke blevet opdateret nævneværdigt i årenes løb, og de i dag anvendte doseringsregimer bygger ikke på pålidelige farmakokinetiske/farmakodynamiske data.
English: • the CHMP considered that the risks of nephrotoxicity and neurotoxicity observed with colistin for parenteral use should be balanced against the risk of the underlying disease and the high mortality from the treated conditions and that it can be satisfactorily mitigated by warnings and recommendations in the SmPC,
Danish: • CHMP fandt, at de iagttagne risici for nefrotoksicitet og neurotoksicitet med parenteralt colistin bør afvejes mod risikoen fra den underliggende sygdom og den høje mortalitet af de behandlede sygdomme, og at risikoen kan imødegås tilfredsstillende gennem advarsler og anbefalinger i produktresuméet.
English: Indeed, recent clinical experience and the medical literature point to the urgent need to update the product information, in particular the indications, the dosage recommendations and the PK/PD information, as highlighted by recent reports of suboptimal efficacy and the emergence of colistin resistance, in particular when used as monotherapy.
Danish: De seneste kliniske erfaringer og den medicinske litteratur tyder da også på, at der er tvingende behov ajourføring af produktinformationen, navnlig indikationer, dosisanbefalinger og farmakokinetiske/farmakodynamiske oplysninger, således som det fremgår af nylige indberetninger om suboptimal effektivitet og udvikling af resistens over for colistin, navnlig når det anvendes som monoterapi.
English: Grounds for the maintenance and the variation to the terms of the marketing authorisation, as applicable
Danish: Begrundelse for opretholdelsen af markedsføringstilladelsen eller ændring af betingelserne for markedsføringstilladelsen, som relevant
English: The Committee, as a consequence, concluded that the benefit-risk balance of the polymyxin-based products included in the scope of this procedure remains positive under normal conditions of use, taking into account the agreed changes to the product information, as applicable.
Danish: konkluderede udvalget, at benefit/risk-forholdet for de af proceduren omfattede polymyxinbaserede lægemidler fortsat var positivt ved normale anvendelsesbetingelser under forudsætning af de relevante vedtagne ændringer af produktinformationen.
English: • the existing preclinical and clinical data and the product information including the indications, dosage recommendations and pharmacokinetic and pharmacodynamic information for polymyxin-based products in the EU are not up to date or based on robust data, as highlighted by recent reports of suboptimal efficacy and the emergence of colistin resistance,
Danish: • De foreliggende prækliniske og kliniske data og produktoplysningerne, herunder indikationer, dosisanbefalinger og farmakokinetiske og farmakodynamiske oplysninger, for polymyxinbaserede lægemidler i EU er ikke ajour eller baseret på pålidelige data, således som det fremgår af indberetninger om suboptimal virkning og fremkomst af colistinresistens.
English: • the CHMP considered that colistimethate sodium and colistin represent a crucial therapeutic option in the context of the treatment of infections caused by multi-drug resistant Gramnegative pathogens,
Danish: • CHMP tog i betragtning, at colistimethatnatrium og colistin er en afgørende vigtig behandlingsmulighed til infektioner forårsaget af multiresistente gramnegative patogener.
English: Therefore, for the medicinal products referred to in Annex I, the CHMP recommended the variation to the terms of the marketing authorisation, for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III to the opinion.
Danish: CHMP anbefalede derfor ændring af betingelserne for markedsføringstilladelsen for de i bilag 1 omhandlede lægemidler, for hvilke de relevante afsnit af produktresuméet og indlægssedlen fremgår af bilag III til udtalelsen.